Levofloxacin compared with imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia: a multicenter, prospective, randomized, open-label study.

PubMed

West, Mike; Boulanger, Bernard R; Fogarty, Charles; Tennenberg, Alan; Wiesinger, Barbara; Oross, Margaret; Wu, Shu-Chen; Fowler, Cynthia; Morgan, Nancy; Kahn, James B

2003-02-01

Therapy of nosocomial pneumonia is usually empiric and includes > or = 1 broad-spectrum antimicrobial agent. When considering the use of fluoroquinolones in these difficult-to-treat infections--in which drug delivery to the site of infection may be impaired or organisms with higher minimum inhibitory concentrations may be present--an agent should be chosen whose pharmacodynamics ensure maximal drug exposure. Use of the 750-mg dose of levofloxacin should enhance therapeutic benefit in patients with nosocomial pneumonia. The goal of this study was to compare the efficacy and safety of levofloxacin 750 mg and imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia. This was a multicenter, prospective, randomized, open-label trial conducted in North America. Patients were randomly assigned to 1 of 2 treatment arms: levofloxacin 750 mg QD given i.v. and then orally for 7 to 15 days or imipenem/cilastatin 500 mg to 1 g i.v. every 6 to 8 hours, followed by oral ciprofloxacin 750 mg every 12 hours for 7 to 15 days. Adjunctive antibacterial therapy was mandatory in patients with documented or suspected Pseudomonas aeruginosa or methicillin-resistant Staphylococcus aureus infection. The primary predefined outcome measure was the clinical response (cure, improvement, failure, or unable to evaluate) in microbiologically evaluable patients 3 to 15 days after the end of therapy. The study enrolled 438 adult patients (315 men, 123 women; mean [SD] age, 55.7 [20.04] years). Two hundred twenty patients received levofloxacin, and 218 received the comparator regimen. Demographic and baseline clinical characteristics were similar in the intent-to-treat and clinically evaluable populations. In patients evaluable for microbiologic efficacy, clinical success (cure or improvement) was achieved in 58.1% (54/93) of patients who received levofloxacin, compared with 60.6% (57/94) of patients who received the comparator regimen (95% CI, -12.0 to 17.2). Similar clinical results were seen in patients evaluable for clinical efficacy and in the intent-to-treat population. In the 187 patients evaluable for microbiologic efficacy, eradication was achieved in 66.7% (62/93) of patients receiving levofloxacin and 60.6% (57/94) of patients receiving the comparator regimen (95% CI, -20.3 to 8.3). In this study, levofloxacin was at least as effective and was as well tolerated as imipenem/cilastatin followed by ciprofloxacin in adult patients with nosocomial pneumonia, as demonstrated by comparable clinical and microbiologic success rates.

Reducing barriers to mental health and social services for Iraq and Afghanistan veterans: outcomes of an integrated primary care clinic.

PubMed

Seal, Karen H; Cohen, Greg; Bertenthal, Daniel; Cohen, Beth E; Maguen, Shira; Daley, Aaron

2011-10-01

Despite high rates of post-deployment psychosocial problems in Iraq and Afghanistan veterans, mental health and social services are under-utilized. To evaluate whether a Department of Veterans Affairs (VA) integrated care (IC) clinic (established in April 2007), offering an initial three-part primary care, mental health and social services visit, improved psychosocial services utilization in Iraq and Afghanistan veterans compared to usual care (UC), a standard primary care visit with referral for psychosocial services as needed. Retrospective cohort study using VA administrative data. Five hundred and twenty-six Iraq and Afghanistan veterans initiating primary care at a VA medical center between April 1, 2005 and April 31, 2009. Multivariable models compared the independent effects of primary care clinic type (IC versus UC) on mental health and social services utilization outcomes. After 2007, compared to UC, veterans presenting to the IC primary care clinic were significantly more likely to have had a within-30-day mental health evaluation (92% versus 59%, p < 0.001) and social services evaluation [77% (IC) versus 56% (UC), p < 0.001]. This exceeded background system-wide increases in mental health services utilization that occurred in the UC Clinic after 2007 compared to before 2007. In particular, female veterans, younger veterans, and those with positive mental health screens were independently more likely to have had mental health and social service evaluations if seen in the IC versus UC clinic. Among veterans who screened positive for  ≥ 1 mental health disorder(s), there was a median of 1 follow-up specialty mental health visit within the first year in both clinics. Among Iraq and Afghanistan veterans new to primary care, an integrated primary care visit further improved the likelihood of an initial mental health and social services evaluation over background increases, but did not improve retention in specialty mental health services.

[Clinical and videofluoroscopic evaluation of deglutition in children with tetraparetic spastic cerebral palsy].

PubMed

Furkim, Ana Maria; Behlau, Mara Suzana; Weckx, Luc Louis Maurice

2003-09-01

Cerebral palsy is a condition that may be associated with swallowing disorders, that is, oropharingeal dysphagia. The aim of this study was to characterize and compare the swallowing processes of 32 children with this condition, by clinical and videofluoroscopic evaluation, with special focus on tracheal aspiration detectability. Results show an important compromise of oral phase. The most important findings during the pharyngeal phase were velopharingeal incompetence and residuals on the pharyngeal recesses. Aspiration was more common with liquids, before and after deglutition. On clinical and videofluoroscopic evaluation, cervical hyperextension was the commonest postural abnormality. Videofluoroscopy confirmed the occurrence of aspiration on most of the cases that presented suggestive signs of aspiration during clinical evaluation. We conclude that clinical and videofluoroscopic evaluations are complementary on deglutition evaluation and together may point to the most specific rehabilitation procedure.

Contrast-enhanced MRI compared with the physical examination in the evaluation of disease activity in juvenile idiopathic arthritis.

PubMed

Hemke, Robert; Maas, Mario; van Veenendaal, Mira; Dolman, Koert M; van Rossum, Marion A J; van den Berg, J Merlijn; Kuijpers, Taco W

2014-02-01

To assess the value of magnetic resonance imaging (MRI) in discriminating between active and inactive juvenile idiopathic arthritis (JIA) patients and to compare physical examination outcomes with MRI outcomes in the assessment of disease status in JIA patients. Consecutive JIA patients with knee involvement were prospectively studied using an open-bore MRI. Imaging findings from 146 JIA patients were analysed (59.6% female; mean age, 12.9 years). Patients were classified as clinically active or inactive. MRI features were evaluated using the JAMRIS system, comprising validated scores for synovial hypertrophy, bone marrow oedema, cartilage lesions and bone erosions. Inter-reader reliability was good for all MRI features (intra-class correlation coefficient [ICC] = 0.87-0.94). No differences were found between the two groups regarding MRI scores of bone marrow oedema, cartilage lesions or bone erosions. Synovial hypertrophy scores differed significantly between groups (P = 0.016). Nonetheless, synovial hypertrophy was also present in 14 JIA patients (35.9%) with clinically inactive disease. Of JIA patients considered clinically active, 48.6% showed no signs of MRI-based synovitis. MRI can discriminate between clinically active and inactive JIA patients. However, physical examination is neither very sensitive nor specific in evaluating JIA disease activity compared with MRI. Subclinical synovitis was present in >35% of presumed clinically inactive patients. • MRI is sensitive for evaluating juvenile idiopathic arthritis (JIA) disease activity. • Contrast-enhanced MRI can distinguish clinically active and inactive JIA patients. • Subclinical synovitis is present in 35.9 % of presumed clinically inactive patients. • Physical examination is neither sensitive nor specific in evaluating JIA disease activity.

Evaluation of clinical practice guidelines.

PubMed Central

Basinski, A S

1995-01-01

Compared with the current focus on the development of clinical practice guidelines the effort devoted to their evaluation is meagre. Yet the ultimate success of guidelines depends on routine evaluation. Three types of evaluation are identified: evaluation of guidelines under development and before dissemination and implementation, evaluation of health care programs in which guidelines play a central role, and scientific evaluation, through studies that provide the scientific knowledge base for further evolution of guidelines. Identification of evaluation and program goals, evaluation design and a framework for evaluation planning are discussed. PMID:7489550

Evaluation of a Rapid Assay for Detection of Chlamydia trachomatis Infections in Outpatient Clinics in South Kalimantan, Indonesia

PubMed Central

Widjaja, Susana; Cohen, Surekha; Brady, William E.; O'reilly, Kevin; Susanto; Wibowo, Ajar; Cahyono; Graham, Robert R.; Porter, Kevin R.

1999-01-01

A multicenter cross-sectional survey was conducted comparing a commercially available chlamydial optical immunoassay (OIA) to the chlamydial ligase chain reaction (LCR). Endocervical samples from 415 outpatients visiting clinics from three hospitals in South Kalimantan, Indonesia, were evaluated. Relative to the LCR, the overall sensitivity and specificity of the OIA were 31.6 and 98.9%, respectively. The sensitivity of the OIA varied among the three hospital laboratories, ranging from 20 to 50%. The OIA performance was slightly lower on samples from patients attending dermatovenereology clinics than on samples from nondermatovenereology clinic patients. The results indicate that the OIA did not perform well compared to LCR. PMID:10565960

Evaluation of a rapid assay for detection of Chlamydia trachomatis infections in outpatient clinics in South Kalimantan, Indonesia.

PubMed

Widjaja, S; Cohen, S; Brady, W E; O'reilly, K; Susanto; Wibowo, A; Cahyono; Graham, R R; Porter, K R

1999-12-01

A multicenter cross-sectional survey was conducted comparing a commercially available chlamydial optical immunoassay (OIA) to the chlamydial ligase chain reaction (LCR). Endocervical samples from 415 outpatients visiting clinics from three hospitals in South Kalimantan, Indonesia, were evaluated. Relative to the LCR, the overall sensitivity and specificity of the OIA were 31.6 and 98.9%, respectively. The sensitivity of the OIA varied among the three hospital laboratories, ranging from 20 to 50%. The OIA performance was slightly lower on samples from patients attending dermatovenereology clinics than on samples from nondermatovenereology clinic patients. The results indicate that the OIA did not perform well compared to LCR.

Evaluating imbalances of adverse events during biosimilar development

PubMed Central

Vana, Alicia M.; Freyman, Amy W.; Reich, Steven D.; Yin, Donghua; Li, Ruifeng; Anderson, Scott; Jacobs, Ira A.; Zacharchuk, Charles M.; Ewesuedo, Reginald

2016-01-01

ABSTRACT Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials. PMID:27050730

Comparators (medicinal and non medicinal) for marketing authorization, for public health, for payers and at the European level.

PubMed

Berdaï, Driss; Hotton, Jean-Michel; Lechat, Philippe

2010-01-01

Drug evaluation is based on comparison. Thus, the choice of the comparator for any new treatment becomes a key issue, especially when there are great differences in medical practice and of use conditions of the comparators depending on the geographical zones and their evolution with time. The choice of the comparators must satisfy sometimes different expectations from the registration authorities and for insurance coverage. The universal comparator that allows answering all the clinical assessment questions does not exist. Placebo, when it can be used, remains a reference for the MA (marketing authorisation) application, but does not exclude the use of the reference drug available on the market and prescribed under optimal efficacy conditions. The reference treatment is sometimes a difficult choice due to the absence of validated therapeutic recommendations or if the recommendations vary depending on the countries. The expansion and international harmonization of prescription guidelines (clinical practice guidelines) would reinforce the robustness and efficiency of clinical research efforts with respect to the relevance of the comparison to reference treatments. This principle also applies to the use of a non-drug comparator when it has been recognized as the reference comparator in the treatment of the pathology in question. In as much as possible, the search for a consensus must also aim at defining in the clinical development recommendations significant thresholds for the size of evaluated effects. Optimization of the information made available after clinical trials could also be helped by the development of use of methodologies that allow assessing superiority on secondary criteria during a non-inferiority study on the main criterion. Finally, the development of early scientific consultations by the Haute Autorité de Santé (HAS, French Health Authority) would contribute to adapt phase III clinical trials better to questions concerning the assessment of the clinical added value of the medicinal products evaluated. © 2010 Société Française de Pharmacologie et de Thérapeutique.

Overview of phase IV clinical trials for postmarket drug safety surveillance: a status report from the ClinicalTrials.gov registry.

PubMed

Zhang, Xinji; Zhang, Yuan; Ye, Xiaofei; Guo, Xiaojing; Zhang, Tianyi; He, Jia

2016-11-23

Phase IV trials are often used to investigate drug safety after approval. However, little is known about the characteristics of contemporary phase IV clinical trials and whether these studies are of sufficient quality to advance medical knowledge in pharmacovigilance. We aimed to determine the fundamental characteristics of phase IV clinical trials that evaluated drug safety using the ClinicalTrials.gov registry data. A data set of 19 359 phase IV clinical studies registered in ClinicalTrials.gov was downloaded. The characteristics of the phase IV trials focusing on safety only were compared with those evaluating both safety and efficacy. We also compared the characteristics of the phase IV trials in three major therapeutic areas (cardiovascular diseases, mental health and oncology). Multivariable logistic regression was used to evaluate factors associated with the use of blinding and randomisation. A total of 4772 phase IV trials were identified, including 330 focusing on drug safety alone and 4392 evaluating both safety and efficacy. Most of the phase IV trials evaluating drug safety (75.9%) had enrolment <300 with 96.5% <3000. Among these trials, 8.2% were terminated or withdrawn. Factors associated with the use of blinding and randomisation included the intervention model, clinical specialty and lead sponsor. Phase IV trials evaluating drug safety in the ClinicalTrials.gov registry were dominated by small trials that might not have sufficient power to detect less common adverse events. An adequate sample size should be emphasised for phase IV trials with safety surveillance as main task. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Northwestern University Flexible Subischial Vacuum Socket for persons with transfemoral amputation: Part 2 Description and Preliminary evaluation

PubMed Central

Fatone, Stefania; Caldwell, Ryan

2017-01-01

Background: Current transfemoral prosthetic sockets are problematic as they restrict function, lack comfort, and cause residual limb problems. Development of a subischial socket with lower proximal trim lines is an appealing way to address this problem and may contribute to improving quality of life of persons with transfemoral amputation. Objectives: The purpose of this study was to illustrate the use of a new subischial socket in two subjects. Study design: Case series. Methods: Two unilateral transfemoral prosthesis users participated in preliminary socket evaluations comparing functional performance of the new subischial socket to ischial containment sockets. Testing included gait analysis, socket comfort score, and performance-based clinical outcome measures (Rapid-Sit-To-Stand, Four-Square-Step-Test, and Agility T-Test). Results: For both subjects, comfort was better in the subischial socket, while gait and clinical outcomes were generally comparable between sockets. Conclusion: While these evaluations are promising regarding the ability to function in this new socket design, more definitive evaluation is needed. Clinical relevance Using gait analysis, socket comfort score and performance-based outcome measures, use of the Northwestern University Flexible Subischial Vaccum Socket was evaluated in two transfemoral prosthesis users. Socket comfort improved for both subjects with comparable function compared to ischial containment sockets. PMID:28132589

Performance characteristics of a conformal ultra-wideband multilayer applicator (CUMLA) for hyperthermia in veterinary patients: a pilot evaluation of its use in the adjuvant treatment of non-resectable tumours.

PubMed

Smrkovski, O A; Koo, Y; Kazemi, R; Lembcke, L M; Fathy, A; Liu, Q; Phillips, J C

2013-03-01

Performance and clinical characteristics of a novel hyperthermia antenna operating at 434 MHz were evaluated for the adjuvant treatment of locally advanced superficial tumours in cats, dogs and horses. Electromagnetic simulations were performed to determine electric field characteristics and compared to simulations for a flat microwave antenna with similar dimensions. Simulation results show a reduced skin surface and backfield irradiation and improved directional irradiation (at broadside) compared to a flat antenna. Radiated power and penetration is notably increased with a penetration depth of 4.59 cm compared to 2.74 cm for the flat antenna. Clinical use of the antenna was then evaluated in six animals with locoregionally advanced solid tumours receiving adjuvant chemotherapy. During clinical applications, therapeutic temperatures were achieved at depths ≥4 cm. Objective responses were seen in all patients; tissue toxicity in one case limited further therapy. This antenna provides compact, efficient, focused and deep-penetrating clinical hyperthermia for the treatment of solid tumours in veterinary patients. © 2011 Blackwell Publishing Ltd.

Evidence of the economic benefit of clinical pharmacy services: 1996-2000.

PubMed

Schumock, Glen T; Butler, Melissa G; Meek, Patrick D; Vermeulen, Lee C; Arondekar, Bhakti V; Bauman, Jerry L

2003-01-01

We sought to summarize and assess original evaluations of the economic impact of clinical pharmacy services published from 1996-2000, and to provide recommendations and methodologic considerations for future research. A systematic literature search was conducted to identify articles that were then blinded and randomly assigned to reviewers who confirmed inclusion and abstracted key information. Results were compared with those of a similar review of literature published from 1988-1995. In the 59 included articles, the studies were conducted across a variety of practice sites that consisted of hospitals (52%), community pharmacies and clinics (41%), health maintenance organizations (3%), and long-term or intermediate care facilities (3%). They focused on a broad range of clinical pharmacy services such as general pharmacotherapeutic monitoring (47%), target drug programs (20%), disease management programs (10%), and patient education or cognitive services (10%). Compared with the studies of the previous review, a greater proportion of evaluations were conducted in community pharmacies or clinics, and the types of services evaluated tended to be more comprehensive rather than specialized. Articles were categorized by type of evaluation: 36% were considered outcome analyses, 24% full economic analyses, 17% outcome descriptions, 15% cost and outcome descriptions, and 8% cost analyses. Compared with the studies of the previous review, a greater proportion of studies in the current review used more rigorous study designs. Most studies reported positive financial benefits of the clinical pharmacy service evaluated. In 16 studies, a benefit:cost ratio was reported by the authors or was able to be calculated by the reviewers (these ranged from 1.7:1-17.0:1, median 4.68:1). The body of literature from this 5-year period provides continued evidence of the economic benefit of clinical pharmacy services. Although the quality of study design has improved, whenever possible, future evaluations of this type should incorporate methodologies that will further enhance the strength of evidence of this literature and the conclusions that may be drawn from it.

A randomized trial comparing INR monitoring devices in patients with anticoagulation self-management: evaluation of a novel error-grid approach.

PubMed

Hemkens, Lars G; Hilden, Kristian M; Hartschen, Stephan; Kaiser, Thomas; Didjurgeit, Ulrike; Hansen, Roland; Bender, Ralf; Sawicki, Peter T

2008-08-01

In addition to the metrological quality of international normalized ratio (INR) monitoring devices used in patients' self-management of long-term anticoagulation, the effectiveness of self-monitoring with such devices has to be evaluated under real-life conditions with a focus on clinical implications. An approach to evaluate the clinical significance of inaccuracies is the error-grid analysis as already established in self-monitoring of blood glucose. Two anticoagulation monitors were compared in a real-life setting and a novel error-grid instrument for oral anticoagulation has been evaluated. In a randomized crossover study 16 patients performed self-management of anticoagulation using the INRatio and the CoaguChek S system. Main outcome measures were clinically relevant INR differences according to established criteria and to the error-grid approach. A lower rate of clinically relevant disagreements according to Anderson's criteria was found with CoaguChek S than with INRatio without statistical significance (10.77% vs. 12.90%; P = 0.787). Using the error-grid we found principally consistent results: More measurement pairs with discrepancies of no or low clinical relevance were found with CoaguChek S, whereas with INRatio we found more differences with a moderate clinical relevance. A high rate of patients' satisfaction with both of the point of care devices was found with only marginal differences. A principal appropriateness of the investigated point-of-care devices to adequately monitor the INR is shown. The error-grid is useful for comparing monitoring methods with a focus on clinical relevance under real-life conditions beyond assessing the pure metrological quality, but we emphasize that additional trials using this instrument with larger patient populations are needed to detect differences in clinically relevant disagreements.

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

PubMed Central

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

2014-01-01

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

Clinical decision support tools: performance of personal digital assistant versus online drug information databases.

PubMed

Clauson, Kevin A; Polen, Hyla H; Marsh, Wallace A

2007-12-01

To evaluate personal digital assistant (PDA) drug information databases used to support clinical decision-making, and to compare the performance of PDA databases with their online versions. Prospective evaluation with descriptive analysis. Five drug information databases available for PDAs and online were evaluated according to their scope (inclusion of correct answers), completeness (on a 3-point scale), and ease of use; 158 question-answer pairs across 15 weighted categories of drug information essential to health care professionals were used to evaluate these databases. An overall composite score integrating these three measures was then calculated. Scores for the PDA databases and for each PDA-online pair were compared. Among the PDA databases, composite rankings, from highest to lowest, were as follows: Lexi-Drugs, Clinical Pharmacology OnHand, Epocrates Rx Pro, mobileMicromedex (now called Thomson Clinical Xpert), and Epocrates Rx free version. When we compared database pairs, online databases that had greater scope than their PDA counterparts were Clinical Pharmacology (137 vs 100 answers, p<0.001), Micromedex (132 vs 96 answers, p<0.001), Lexi-Comp Online (131 vs 119 answers, p<0.001), and Epocrates Online Premium (103 vs 98 answers, p=0.001). Only Micromedex online was more complete than its PDA version (p=0.008). Regarding ease of use, the Lexi-Drugs PDA database was superior to Lexi-Comp Online (p<0.001); however, Epocrates Online Premium, Epocrates Online Free, and Micromedex online were easier to use than their PDA counterparts (p<0.001). In terms of composite scores, only the online versions of Clinical Pharmacology and Micromedex demonstrated superiority over their PDA versions (p>0.01). Online and PDA drug information databases assist practitioners in improving their clinical decision-making. Lexi-Drugs performed significantly better than all of the other PDA databases evaluated. No PDA database demonstrated superiority to its online counterpart; however, the online versions of Clinical Pharmacology and Micromedex were superior to their PDA versions in answering questions.

Standardization of Clinical Skill Evaluation in Physical/Occupational Therapist Education –Effects of Introduction of an Education System Using OSCE–

PubMed Central

Sakurai, Hiroaki; Kanada, Yoshikiyo; Sugiura, Yoshito; Motoya, Ikuo; Yamada, Masayuki; Tomita, Masao; Naka, Toru; Teranishi, Toshio; Tanabe, Shigeo; Tsujimura, Toru; Okanishi, Tetsuo

2013-01-01

[Purpose] A major issue in physical/occupational therapist education is the improvement of students' clinical techniques. In this study, we introduced an education system using an Objective Structured Clinical Examination (OSCE), and made an attempt at standardization of its evaluation. [Subjects] The subjects were 227 students in the classes of 2008 to 2010 who enrolled at our university between 2004 and 2006, before the introduction of the education system using OSCE, and 221 students in the classes of 2011 to 2013 who enrolled between 2007 and 2009, after the introduction. [Methods] Performances in attitude and skills (performance in clinical training and OSCE) were compared between before and after the introduction of OSCE. OSCE results were compared between before and after clinical trainings at each OSCE Level; and the correlation of between performances in clinical training and OSCE was examined. [Results] Performances in OSCE and clinical training (attitude, skills) were improved by the introduction of the education system using OSCE, but no significant correlation was observed in the relationship between performances in OSCE and clinical training. [Conclusion] Further studies should be conducted aiming at the standardization of clinical skill evaluation in postgraduate education to establish an education system using OSCE. PMID:24259918

A Clinical Evaluation of Cone Beam Computed Tomography

DTIC Science & Technology

2013-07-31

body of literature lacks in vivo studies comparing CBCT images with clinical findings. The purpose of this descriptive case series was to...All (18/18) bone measurements were underrepresented on CBCT images in this study . This case series also identified limitations in accuracy when... study was to compare pre-surgical CBCT images against the actual clinical presentation of the hard tissues. METHOD: Eleven patients requiring

Evaluation of drug reviews.

PubMed

Hendrickson, N M; Amerson, A B

1986-10-01

Drug reviews appearing in Clinical Pharmacy, Drug Intelligence and Clinical Pharmacy (DICP), Drugs, and Pharmacotherapy from January 1982 through December 1984 were evaluated for number, duplication among journals, timeliness, scope, and format. The design of this study was primarily quantitative rather than qualitative. Pharmacotherapy published the most reviews (49), followed by Drugs (43), Clinical Pharmacy (37), and DICP (29). Drugs and Pharmacotherapy published the largest number of unique reviews (agents not reviewed by the other journals during the study period), while Pharmacotherapy and Clinical Pharmacy published the most reviews on newly marketed drugs. Reviews of four drugs (acyclovir, moxalactam, ranitidine, and trazodone) were compared in terms of major sections, terminology and format, bibliography, use of tables and figures, scope of evaluative comments, and review process. Reviews in Drugs consistently contained the most references and tables and provided the most detail. Information was most accessible in Drugs, followed by Pharmacotherapy. Drugs used the largest panel of reviewers. All of the journals provided evaluative comments, although the scope varied. Continuing-education credit is available for review articles in Clinical Pharmacy and DICP. In selecting one or more of these journals, individuals or institutions should compare their needs with regard to the timeliness, scope, and format of the review articles in each journal.

What is the role of combination drug therapy in the treatment of overactive bladder? ICI-RS 2014.

PubMed

Visco, Anthony G; Fraser, Matthew O; Newgreen, Donald; Oelke, Matthias; Cardozo, Linda

2016-02-01

The role of combination therapy using oral antimuscarinic medications for the treatment of overactive bladder was proposed at the 2014 International Consultation on Incontinence-Research Society in Bristol, UK to identify key factors to consider when making clinical decisions and to guide future research design. Combination therapy is justified if monotherapy is associated with suboptimal efficacy or bothersome side effects. Combination therapy has the potential to improve efficacy with fewer side effects than monotherapy. Two Phase 2 studies comparing combination therapy that included an antimuscarinic demonstrated improvement in mean voided volume, the primary outcome chosen, with some combinations showing improved micturition frequency and quality of life. The two studies found no evidence of an increased safety risk with combination therapy compared to monotherapy. Future studies should use clinically meaningful or patient reported outcomes such as incontinence episodes when comparing efficacy. If surrogate measures are used, a clear justification should be provided. Cost analyses should be planned for clinical research trials evaluating combination drug therapy. Combination therapy is reasonable when monotherapy has suboptimal efficacy or bothersome side effects. Future research studies evaluating combination therapy for urgency urinary incontinence should ideally(1) be performed as part of a randomized clinical trial,(2) evaluate non-responders to monotherapy,(3) evaluate combination therapy using medications with different mechanisms of action,(4) include clinically meaningful and patient reported outcomes when evaluating efficacy, and(5) include cost-effectiveness analyses to justify any increased cost by showing improvement in efficacy or reduction in side effects. © 2016 Wiley Periodicals, Inc.

The case for introducing pre-registered confirmatory pharmacological pre-clinical studies.

PubMed

Kiwanuka, Olivia; Bellander, Bo-Michael; Hånell, Anders

2018-05-01

When evaluating the design of pre-clinical studies in the field of traumatic brain injury, we found substantial differences compared to phase III clinical trials, which in part may explain the difficulties in translating promising experimental drugs into approved treatments. By using network analysis, we also found cases where a large proportion of the studies evaluating a pre-clinical treatment was performed by inter-related researchers, which is potentially problematic. Subjecting all pre-clinical trials to the rigor of a phase III clinical trial is, however, likely not practically achievable. Instead, we repeat the call for a distinction to be made between exploratory and confirmatory pre-clinical studies.

Cost-effectiveness of health research study participant recruitment strategies: a systematic review.

PubMed

Huynh, Lynn; Johns, Benjamin; Liu, Su-Hsun; Vedula, S Swaroop; Li, Tianjing; Puhan, Milo A

2014-10-01

A large fraction of the cost of conducting clinical trials is allocated to recruitment of participants. A synthesis of findings from studies that evaluate the cost and effectiveness of different recruitment strategies will inform investigators in designing cost-efficient clinical trials. To systematically identify, assess, and synthesize evidence from published comparisons of the cost and yield of strategies for recruitment of participants to health research studies. We included randomized studies in which two or more strategies for recruitment of participants had been compared. We focused our economic evaluation on studies that randomized participants to different recruitment strategies. We identified 10 randomized studies that compared recruitment strategies, including monetary incentives (cash or prize), direct contact (letters or telephone call), and medical referral strategies. Only two of the 10 studies compared strategies for recruiting participants to clinical trials. We found that allocating additional resources to recruit participants using monetary incentives or direct contact yielded between 4% and 23% additional participants compared to using neither strategy. For medical referral, recruitment of prostate cancer patients by nurses was cost-saving compared to recruitment by consultant urologists. For all underlying study designs, monetary incentives cost more than direct contact with potential participants, with a median incremental cost per recruitment ratio of Int$72 (Int$-International dollar, a theoretical unit of currency) for monetary incentive strategy compared to Int$28 for direct contact strategy. Only monetary incentives and source of referral were evaluated for recruiting participants into clinical trials. We did not review studies that presented non-monetary cost or lost opportunity cost. We did not adjust for the number of study recruitment sites or the study duration in our economic evaluation analysis. Systematic and explicit reporting of cost and effectiveness of recruitment strategies from randomized comparisons is required to aid investigators to select cost-efficient strategies for recruiting participants to health research studies including clinical trials. © The Author(s) 2014.

Psychotic Disorders in Learning Disabilities--Outcome of an Audit across Community Teams

ERIC Educational Resources Information Center

Varghese, Susan; Banerjee, Subimal

2011-01-01

The aim of the audit was to evaluate the current clinical practice for learning-disabled individuals with psychotic disorders. We evaluated the existing clinical practice in 910 individuals who were under the care of learning disability psychiatrists in Buckinghamshire (population of 480 000). This was compared with the National Institute for…

Dose reduction of up to 89% while maintaining image quality in cardiovascular CT achieved with prospective ECG gating

NASA Astrophysics Data System (ADS)

Londt, John H.; Shreter, Uri; Vass, Melissa; Hsieh, Jiang; Ge, Zhanyu; Adda, Olivier; Dowe, David A.; Sabllayrolles, Jean-Louis

2007-03-01

We present the results of dose and image quality performance evaluation of a novel, prospective ECG-gated Coronary CT Angiography acquisition mode (SnapShot Pulse, LightSpeed VCT-XT scanner, GE Healthcare, Waukesha, WI), and compare it to conventional retrospective ECG gated helical acquisition in clinical and phantom studies. Image quality phantoms were used to measure noise, slice sensitivity profile, in-plane resolution, low contrast detectability and dose, using the two acquisition modes. Clinical image quality and diagnostic confidence were evaluated in a study of 31 patients scanned with the two acquisition modes. Radiation dose reduction in clinical practice was evaluated by tracking 120 consecutive patients scanned with the prospectively gated scan mode. In the phantom measurements, the prospectively gated mode resulted in equivalent or better image quality measures at dose reductions of up to 89% compared to non-ECG modulated conventional helical scans. In the clinical study, image quality was rated excellent by expert radiologist reviewing the cases, with pathology being identical using the two acquisition modes. The average dose to patients in the clinical practice study was 5.6 mSv, representing 50% reduction compared to a similar patient population scanned with the conventional helical mode.

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

Student assessment by objective structured examination in a neurology clerkship

PubMed Central

Adesoye, Taiwo; Smith, Sandy; Blood, Angela; Brorson, James R.

2012-01-01

Objectives: We evaluated the reliability and predictive ability of an objective structured clinical examination (OSCE) in the assessment of medical students at the completion of a neurology clerkship. Methods: We analyzed data from 195 third-year medical students who took the OSCE. For each student, the OSCE consisted of 2 standardized patient encounters. The scores obtained from each encounter were compared. Faculty clinical evaluations of each student for 2 clinical inpatient rotations were also compared. Hierarchical regression analysis was applied to test the ability of the averaged OSCE scores to predict standardized written examination scores and composite clinical scores. Results: Students' OSCE scores from the 2 standardized patient encounters were significantly correlated with each other (r = 0.347, p < 0.001), and the scores for all students were normally distributed. In contrast, students' faculty clinical evaluation scores from 2 different clinical inpatient rotations were uncorrelated, and scores were skewed toward the highest ratings. After accounting for clerkship order, better OSCE scores were predictive of better National Board of Medical Examiners standardized examination scores (R2Δ = 0.131, p < 0.001) and of better faculty clinical scores (R2Δ = 0.078, p < 0.001). Conclusions: Student assessment by an OSCE provides a reliable and predictive objective assessment of clinical performance in a neurology clerkship. PMID:22855865

WE-F-201-03: Evaluate Clinical Cases Using Commercially Available Systems and Compare to TG-43 Dosimetry

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

Beaulieu, L.

With the recent introduction of heterogeneity correction algorithms for brachytherapy, the AAPM community is still unclear on how to commission and implement these into clinical practice. The recently-published AAPM TG-186 report discusses important issues for clinical implementation of these algorithms. A charge of the AAPM-ESTRO-ABG Working Group on MBDCA in Brachytherapy (WGMBDCA) is the development of a set of well-defined test case plans, available as references in the software commissioning process to be performed by clinical end-users. In this practical medical physics course, specific examples on how to perform the commissioning process are presented, as well as descriptions of themore » clinical impact from recent literature reporting comparisons of TG-43 and heterogeneity-based dosimetry. Learning Objectives: Identify key clinical applications needing advanced dose calculation in brachytherapy. Review TG-186 and WGMBDCA guidelines, commission process, and dosimetry benchmarks. Evaluate clinical cases using commercially available systems and compare to TG-43 dosimetry.« less

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections

PubMed Central

2012-01-01

Background Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality. Methods In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196). Results In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group. Conclusions Tigecycline was generally safe and effective in the treatment of cSSSIs. Trial registration ClinicalTrials.gov NCT00368537 PMID:23145952

A randomized trial of tigecycline versus ampicillin-sulbactam or amoxicillin-clavulanate for the treatment of complicated skin and skin structure infections.

PubMed

Matthews, Peter; Alpert, Marc; Rahav, Galia; Rill, Denise; Zito, Edward; Gardiner, David; Pedersen, Ron; Babinchak, Timothy; McGovern, Paul C

2012-11-12

Complicated skin and skin structure infections (cSSSIs) frequently result in hospitalization with significant morbidity and mortality. In this phase 3b/4 parallel, randomized, open-label, comparative study, 531 subjects with cSSSI received tigecycline (100 mg initial dose, then 50 mg intravenously every 12 hrs) or ampicillin-sulbactam 1.5-3 g IV every 6 hrs or amoxicillin-clavulanate 1.2 g IV every 6-8 hrs. Vancomycin could be added at the discretion of the investigator to the comparator arm if methicillin-resistant Staphylococcus aureus (MRSA) was confirmed or suspected within 72 hrs of enrollment. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test-of-cure (TOC) visit. Microbiologic response and safety were also assessed. The modified intent-to-treat (mITT) population comprised 531 subjects (tigecycline, n = 268; comparator, n = 263) and 405 were clinically evaluable (tigecycline, n = 209; comparator, n = 196). In the CE population, 162/209 (77.5%) tigecycline-treated subjects and 152/196 (77.6%) comparator-treated subjects were clinically cured (difference 0.0; 95% confidence interval [CI]: -8.7, 8.6). The eradication rates at the subject level for the microbiologically evaluable (ME) population were 79.2% in the tigecycline treatment group and 76.8% in the comparator treatment group (difference 2.4; 95% CI: -9.6, 14.4) at the TOC assessment. Nausea, vomiting, and diarrhea rates were higher in the tigecycline group. Tigecycline was generally safe and effective in the treatment of cSSSIs. ClinicalTrials.gov NCT00368537.

[The role of the quality of hospital discharge records on the comparative evaluation of outcomes: the example of chronic obstructive pulmonary disease (COPD)].

PubMed

Fano, Valeria; D'Ovidio, Mariangela; del Zio, Katiuscia; Renzi, Davide; Tariciotti, Daniela; Agabiti, Nera; Argenti, Lucia; Cattaruzza, Maria Sofia; Fortino, Antonio

2012-01-01

To analyse the results of the regional comparative evaluation of the outcome "thirty days mortality after admission for reacutized Chronic obstructive pulmonary disease (COPD)" before and after a reabstract study. Reabstract study of clinical records included in the regional comparative evaluation. 232 clinical records retrieved from Grassi Hospital archives (years 2006-2007) and reviewed by two physicians and one nurse specifically trained. Models performed before and after reabstract study for comparative evaluation of the outcome were compared. Blind coding of diagnosis and interventions/procedures was completed according to a standard grid consistent with regional guidelines for Hospital Discharge Record coding. Other information was registered, if present on discharge record: smoking habit, number of reacutizations occurred within previous year, use of oxigen and/or other therapies, pneumological visit at discharge. The majority (94%) of reviewed cases were confirmed as being cases of COPD. A total of 168 cases (72%) have been identified as reacutized COPD coherent with enrolment criteria of regional program, 49 (21%) have been identified as COPD and only 15 cases (6%) resulted not affected by COPD. Results of the regional comparative model were substantially unchanged for Grassi hospital (RR =23 vs RR =24). Accurateness of clinical documentation resulted inadequate especially regarding information at discharge (50% missing information on smoking habit, 83% on previous year reacutizations, 22% on follow-up organization after discharge). This study contributes to the debate on the role of administrative data on the comparative evaluation of health outcomes. Other relevant issues are to promote the collaboration among different health professionals working in the same hospital, and to increase the awareness of the importance of the quality of health and administrative data.

Understanding resident ratings of teaching in the workplace: a multi-centre study.

PubMed

Fluit, Cornelia R M G; Feskens, Remco; Bolhuis, Sanneke; Grol, Richard; Wensing, Michel; Laan, Roland

2015-08-01

Providing clinical teachers with feedback about their teaching skills is a powerful tool to improve teaching. Evaluations are mostly based on questionnaires completed by residents. We investigated to what extent characteristics of residents, clinical teachers, and the clinical environment influenced these evaluations, and the relation between residents' scores and their teachers' self-scores. The evaluation and feedback for effective clinical teaching questionnaire (EFFECT) was used to (self)assess clinical teachers from 12 disciplines (15 departments, four hospitals). Items were scored on a five-point Likert scale. Main outcome measures were residents' mean overall scores (MOSs), specific scale scores (MSSs), and clinical teachers' self-evaluation scores. Multilevel regression analysis was used to identify predictors. Residents' scores and self-evaluations were compared. Residents filled in 1,013 questionnaires, evaluating 230 clinical teachers. We received 160 self-evaluations. 'Planning Teaching' and 'Personal Support' (4.52, SD .61 and 4.53, SD .59) were rated highest, 'Feedback Content' (CanMEDS related) (4.12, SD .71) was rated lowest. Teachers in affiliated hospitals showed highest MOS and MSS. Medical specialty did not influence MOS. Female clinical teachers were rated higher for most MSS, achieving statistical significance. Residents in year 1-2 were most positive about their teachers. Residents' gender did not affect the mean scores, except for role modeling. At group level, self-evaluations and residents' ratings correlated highly (Kendall's τ 0.859). Resident evaluations of clinical teachers are influenced by teacher's gender, year of residency training, type of hospital, and to a lesser extent teachers' gender. Clinical teachers and residents agree on strong and weak points of clinical teaching.

Comparative Studies of Collaborative Team Depression Care Adoption in Safety Net Clinics

ERIC Educational Resources Information Center

Ell, Kathleen; Wu, Shinyi; Guterman, Jeffrey; Schulman, Sandra-Gross; Sklaroff, Laura; Lee, Pey-Jiuan

2018-01-01

Purpose: To evaluate three approaches adopting collaborative depression care model in Los Angeles County safety net clinics with predominantly Latino type 2 diabetes patients. Methods: Pre-post differences in treatment rates and symptom reductions were compared between baseline, 6-month, and 12-month follow-ups for each approach: (a) Multifaceted…

Periocular mexametric melanin and erythema indexes in adult glaucoma patients treated with topical prostaglandin analogs.

PubMed

Duman, Nilay; Duman, Reşat; Yavaş, Güliz Fatma; Doğruk Kaçar, Seval; Özuğuz, Pınar; Çetinkaya, Ersan

2017-03-01

Although topical prostaglandin analogs (PGAs) have been previously associated with periocular skin hyperpigmentation, studies using objective clinical methods are lacking. Furthermore changes in periocular skin erythema indexes associated with topical PGAs have not been reported previously. The purpose of the present study was to evaluate periocular melanin and erythema indexes in patients treated with topical PGA using an objective clinical method - Mexameter. About 45 glaucoma patients treated with topical PGA therapy, and 30 age-, and sex-matched controls were enrolled in the study. Demographic data, medical history including duration of therapy, PGA type, involved eye (unilateral, bilateral) were noted, and skin phototypes were evaluated. Melanin and erythema indexes on medial and lateral upper and lower eyelids, and normal skin from the upper cheeks were measured using Mexameter MX-18. The index of difference for lower/upper eyelid was calculated. Reading results of patients and controls were compared. Melanin and erythema indexes of upper/lower eyelids, and the index of differences for upper/lower eyelids were significantly higher in patients despite similar clinical findings (p < 0.05). Duration of therapy and type of PGA were not associated with skin changes (p > 0.05). Both periocular melanin and erythema indexes increased in both upper and lower eyelids due to PGA therapy compared to controls, despite similar clinical findings. Mexametric evaluation is more sensitive than clinical evaluation, and may be used as an objective, sensitive clinical method to evaluate periocular skin changes, even smallest changes, in such patients.

A Clinician-Centered Evaluation of the Usability of AHLTA and Automated Clinical Practice Guidelines at TAMC

DTIC Science & Technology

2011-03-31

evidence based medicine into clinical practice. It will decrease costs and enable multiple stakeholders to work in an open content/source environment to exchange clinical content, develop and test technology and explore processes in applied CDS. Design: Comparative study between the KMR infrastructure and capabilities developed as an open source, vendor agnostic solution for aCPG execution within AHLTA and the current DoD/MHS standard evaluating: H1: An open source, open standard KMR and Clinical Decision Support Engine can enable organizations to share domain

Evaluation of a pediatric liquid formulation to improve 6-mercaptopurine therapy in children.

PubMed

Tiphaine, Adam de Beaumais; Hjalgrim, Lisa Lynqsie; Nersting, Jacob; Breitkreutz, Joerg; Nelken, Brigitte; Schrappe, Martin; Stanulla, Martin; Thomas, Caroline; Bertrand, Yves; Leverger, Guy; Baruchel, André; Schmiegelow, Kjeld; Jacqz-Aigrain, Evelyne

2016-02-15

6-mercaptopurine (6-MP), a key drug for treatment of acute lymphoblastic leukemia (ALL), has until recently had no adequate formulation for pediatric patients. Several approaches have been taken but the only oral paraben-free 6-MP liquid formulation named Loulla was developed and evaluated in the target population. Preclinical and clinical evaluations were performed according to a Pediatric Investigation Plan, in order to apply for a Pediatric Use Marketing Authorization. The pre-clinical study assessed the maximum tolerated dosage-volume and evaluated local mucosal toxicity of 28 daily administrations in treated compared to controls gold hamsters. The multi-centre clinical study was single-dose, open-label, crossover trial, conducted in 15 ALL children during maintenance therapy. The bioavailability and palatability of a single 50mg fixed dose of Loulla compared to 50mg registered tablets were evaluated in a random order on two consecutive days. Seven blood samples over 9h were obtained each day to determine 6-MP pharmacokinetic parameters, including Tmax, Cmax, AUC0-9 and AUC0-∞. A questionnaire adapted to children testing Loulla palatability and preference for either Loulla or the usual 6-MP tablet was completed. Occurrence of adverse events was determined at study visits by vital sign measurements, patient's spontaneous reporting, investigator's questioning and clinical examination. The preclinical study in gold hamsters showed that dosage-volume of 75 mg/kg/day was well tolerated. The relative bioavailability of liquid Loulla formulation compared to the reference presentation is 76% for AUC0-9 and AUC0-∞ and 80% for Cmax. The taste of Loulla and the mouth feeling after ingestion compare favorably to the tablet. No adverse event occurred. Pharmacokinetic, palatability and safety data support the use of Loulla in children. Copyright © 2015 Elsevier B.V. All rights reserved.

[The comparative evaluation of level of security culture in medical organizations].

PubMed

Roitberg, G E; Kondratova, N V; Galanina, E V

2016-01-01

The study was carried out on the basis of clinic “Medicine” in 2014-2015 concerning security culture. The sampling included 465 filled HSPSC questionnaires. The comparative analysis of received was implemented. The “Zubovskaia district hospital” Having no accreditation according security standards and group of clinics from USA functioning for many years in the system of patient security support were selected as objects for comparison. The evaluation was implemented concerning dynamics of security culture in organization at implementation of strategies of security of patients during 5 years and comparison of obtained results with USA clinics was made. The study results demonstrated that in conditions of absence of implemented standards of security in medical organization total evaluation of security remains extremely low. The study of security culture using HSPSC questionnaire is an effective tool for evaluating implementation of various strategies of security ofpatient. The functioning in the system of international standards of quality, primarily JCI standards, permits during several years to achieve high indices of security culture.

Spontaneous Swallow Frequency Compared with Clinical Screening in the Identification of Dysphagia in Acute Stroke

PubMed Central

Crary, Michael A.; Carnaby, Giselle D.; Sia, Isaac

2017-01-01

Background The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. Methods In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Results Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Conclusions Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. PMID:25088166

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

PubMed

Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

2014-09-01

The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

[What and how to evaluate clinical-surgical competence. The resident and staff surgeon perspective].

PubMed

Cervantes-Sánchez, Carlos Roberto; Chávez-Vizcarra, Paola; Barragán-Ávila, María Cristina; Parra-Acosta, Haydee; Herrera-Mendoza, Renzo Eduardo

2016-01-01

Evaluation is a means for significant and rigorous improvement of the educational process. Therefore, competence evaluation should allow assessing the complex activity of medical care, as well as improving the training process. This is the case in the evaluation process of clinical-surgical competences. A cross-sectional study was designed to measure knowledge about the evaluation of clinical-surgical competences for the General Surgery residency program at the Faculty of Medicine, Universidad Autónoma de Chihuahua (UACH). A 55-item questionnaire divided into six sections was used (perception, planning, practice, function, instruments and strategies, and overall evaluation), with a six level Likert scale, performing a descriptive, correlation and comparative analysis, with a significance level of 0.001. In both groups perception of evaluation was considered as a further qualification. As regards tools, the best known was the written examination. As regards function, evaluation was considered as a further administrative requirement. In the correlation analysis, evaluation was perceived as qualification and was significantly associated with measurement, assessment and accreditation. In the comparative analysis between residents and staff surgeons, a significant difference was found as regards the perception of the evaluation as a measurement of knowledge (Student t test: p=0.04). The results provide information about the concept we have about the evaluation of clinical-surgical competences, considering it as a measure of learning achievement for a socially required certification. There is confusion as regards the perception of evaluation, its function, goals and scopes as benefit for those evaluated. Copyright © 2015 Academia Mexicana de Cirugía A.C. Published by Masson Doyma México S.A. All rights reserved.

Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation.

PubMed

Edwards, Steven J; Barton, Samantha; Thurgar, Elizabeth; Trevor, Nicola

2015-01-01

Ovarian cancer is the fifth most common cancer in the UK, and the fourth most common cause of cancer death. Of those people successfully treated with first-line chemotherapy, 55-75% will relapse within 2 years. At this time, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrent, advanced ovarian cancer. To determine the comparative clinical effectiveness and cost-effectiveness of topotecan (Hycamtin(®), GlaxoSmithKline), pegylated liposomal doxorubicin hydrochloride (PLDH; Caelyx(®), Schering-Plough), paclitaxel (Taxol(®), Bristol-Myers Squibb), trabectedin (Yondelis(®), PharmaMar) and gemcitabine (Gemzar(®), Eli Lilly and Company) for the treatment of advanced, recurrent ovarian cancer. Electronic databases (MEDLINE(®), EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) and trial registries were searched, and company submissions were reviewed. Databases were searched from inception to May 2013. A systematic review of the clinical and economic literature was carried out following standard methodological principles. Double-blind, randomised, placebo-controlled trials, evaluating topotecan, PLDH, paclitaxel, trabectedin and gemcitabine, and economic evaluations were included. A network meta-analysis (NMA) was carried out. A de novo economic model was developed. For most outcomes measuring clinical response, two networks were constructed: one evaluating platinum-based regimens and one evaluating non-platinum-based regimens. In people with platinum-sensitive disease, NMA found statistically significant benefits for PLDH plus platinum, and paclitaxel plus platinum for overall survival (OS) compared with platinum monotherapy. PLDH plus platinum significantly prolonged progression-free survival (PFS) compared with paclitaxel plus platinum. Of the non-platinum-based treatments, PLDH monotherapy and trabectedin plus PLDH were found to significantly increase OS, but not PFS, compared with topotecan monotherapy. In people with platinum-resistant/-refractory (PRR) disease, NMA found no statistically significant differences for any treatment compared with alternative regimens in OS and PFS. Economic modelling indicated that, for people with platinum-sensitive disease and receiving platinum-based therapy, the estimated probabilistic incremental cost-effectiveness ratio [ICER; incremental cost per additional quality-adjusted life-year (QALY)] for paclitaxel plus platinum compared with platinum was £24,539. Gemcitabine plus carboplatin was extendedly dominated, and PLDH plus platinum was strictly dominated. For people with platinum-sensitive disease and receiving non-platinum-based therapy, the probabilistic ICERs associated with PLDH compared with paclitaxel, and trabectedin plus PLDH compared with PLDH, were estimated to be £25,931 and £81,353, respectively. Topotecan was strictly dominated. For people with PRR disease, the probabilistic ICER associated with topotecan compared with PLDH was estimated to be £324,188. Paclitaxel was strictly dominated. As platinum- and non-platinum-based treatments were evaluated separately, the comparative clinical effectiveness and cost-effectiveness of these regimens is uncertain in patients with platinum-sensitive disease. For platinum-sensitive disease, it was not possible to compare the clinical effectiveness and cost-effectiveness of platinum-based therapies with non-platinum-based therapies. For people with platinum-sensitive disease and treated with platinum-based therapies, paclitaxel plus platinum could be considered cost-effective compared with platinum at a threshold of £30,000 per additional QALY. For people with platinum-sensitive disease and treated with non-platinum-based therapies, it is unclear whether PLDH would be considered cost-effective compared with paclitaxel at a threshold of £30,000 per additional QALY; trabectedin plus PLDH is unlikely to be considered cost-effective compared with PLDH. For patients with PRR disease, it is unlikely that topotecan would be considered cost-effective compared with PLDH. Randomised controlled trials comparing platinum with non-platinum-based treatments might help to verify the comparative effectiveness of these regimens. This study is registered as PROSPERO CRD42013003555. The National Institute for Health Research Health Technology Assessment programme.

The enteral vs parenteral nutrition debate revisited.

PubMed

Thomson, Andrew

2008-01-01

Many trials and several meta-analyses have been devoted to comparing enteral with parenteral nutrition support. In this review, these studies are subjected to critical analysis with particular emphasis on their methodology and clinical relevance. Evidence is produced to suggest that the heterogeneous patient populations of the studies and the rigid approach taken to comparing different nutrition therapies inter alia render their conclusions highly questionable and of very doubtful clinical significance. An alternative approach to nutrition research is suggested in which strategies of nutrition support rather than fixed menus are compared. It is suggested that objective measures of intestinal function be evaluated more fully in patients requiring nonvolitional nutrition support, and these are briefly reviewed. In addition, a more scientific approach to evaluating the physiological effects of nutrition support, including chemical tagging and evaluation of muscle function, is recommended.

Digital transillumination in caries detection versus radiographic and clinical methods: an in-vivo study

PubMed Central

Lara-Capi, Cynthia; Lingström, Peter; Lai, Gianfranco; Cocco, Fabio; Simark-Mattsson, Charlotte; Campus, Guglielmo

2017-01-01

Objectives: This article aimed to evaluate: (a) the agreement between a near-infrared light transillumination device and clinical and radiographic examinations in caries lesion detection and (b) the reliability of images captured by the transillumination device. Methods: Two calibrated examiners evaluated the caries status in premolars and molars on 52 randomly selected subjects by comparing the transillumination device with a clinical examination for the occlusal surfaces and by comparing the transillumination device with a radiographic examination (bitewing radiographs) for the approximal surfaces. Forty-eight trained dental hygienists evaluated and reevaluated 30 randomly selected images 1-month later. Results: A high concordance between transillumination method and clinical examination (kappa = 0.99) was detected for occlusal caries lesions, while for approximal surfaces, the transillumination device identified a higher number of lesions with respect to bitewing (kappa = 0.91). At the dentinal level, the two methods identified the same number of caries lesions (kappa = 1), whereas more approximal lesions were recorded using the transillumination device in the enamel (kappa = 0.24). The intraexaminer reliability was substantial/almost perfect in 59.4% of the participants. Conclusions: The transillumination method showed a high concordance compared with traditional methods (clinical examination and bitewing radiographs). Caries detection reliability using the transillumination device images showed a high intraexaminer agreement. Transillumination showed to be a reliable method and as effective as traditional methods in caries detection. PMID:28191797

Novel method for evaluation of eye movements in patients with narcolepsy.

PubMed

Christensen, Julie A E; Kempfner, Lykke; Leonthin, Helle L; Hvidtfelt, Mathias; Nikolic, Miki; Kornum, Birgitte Rahbek; Jennum, Poul

2017-05-01

Narcolepsy causes abnormalities in the control of wake-sleep, non-rapid-eye-movement (non-REM) sleep and REM sleep, which includes specific eye movements (EMs). In this study, we aim to evaluate EM characteristics in narcolepsy as compared to controls using an automated detector. We developed a data-driven method to detect EMs during sleep based on two EOG signals recorded as part of a polysomnography (PSG). The method was optimized using the manually scored hypnograms from 36 control subjects. The detector was applied on a clinical sample with subjects suspected for central hypersomnias. Based on PSG, multiple sleep latency test and cerebrospinal fluid hypocretin-1 measures, they were divided into clinical controls (N = 20), narcolepsy type 2 (NT2, N = 19), and narcolepsy type 1 (NT1, N = 28). We investigated the distribution of EMs across sleep stages and cycles. NT1 patients had significantly less EMs during wake, N1, and N2 sleep and more EMs during REM sleep compared to clinical controls, and significantly less EMs during wake and N1 sleep compared to NT2 patients. Furthermore, NT1 patients showed less EMs during NREM sleep in the first sleep cycle and more EMs during NREM sleep in the second sleep cycle compared to clinical controls and NT2 patients. NT1 patients show an altered distribution of EMs across sleep stages and cycles compared to NT2 patients and clinical controls, suggesting that EMs are directly or indirectly controlled by the hypocretinergic system. A data-driven EM detector may contribute to the evaluation of narcolepsy and other disorders involving the control of EMs. Copyright © 2016 Elsevier B.V. All rights reserved.

The perceived value of clinical pharmacy service provision by pharmacists and physicians: an initial assessment of family medicine and internal medicine providers.

PubMed

Wietholter, Jon P; Ponte, Charles D; Long, Dustin M

2017-10-01

Few publications have addressed the perceptions of pharmacists and physicians regarding the value of clinical pharmacist services. A survey-based study was conducted to determine whether Internal Medicine (IM) and Family Medicine (FM) pharmacists and physicians differed in their attitudes regarding the benefits of collaboration in an acute care setting. The primary objective was to evaluate perceived differences regarding self-assessment of value between IM and FM pharmacists. The secondary objective was to evaluate perceived differences of clinical pharmacist benefit between IM and FM physicians. An eight-item questionnaire assessed the attitudes and beliefs of pharmacists and physicians regarding the value of clinical pharmacy services. Surveys were emailed and participants marked their responses using a 7-point Likert scale for each item. Demographic data and overall comments were collected from each participant. Overall, 167 surveys were completed. When comparing cumulative physician and pharmacist responses, none of the eight questions showed significant differences. Statistically significant differences were noted when comparing IM and FM clinical pharmacists on five of the eight survey items; for each of these items, FM pharmacists had more favourable perceptions than their IM counterparts. No statistically significant differences were noted when comparing responses of IM and FM physicians. This study found that FM pharmacists perceived a greater benefit regarding participation in inpatient acute care rounds when compared to their IM pharmacist counterparts. Future studies are necessary to determine if other medical specialties' perceptions of clinical pharmacy provision differ from our findings and to evaluate the rationale behind specific attitudes and behaviours. © 2016 Royal Pharmaceutical Society.

Development and Evaluation of a Clinical Note Section Header Terminology

PubMed Central

Denny, Joshua C.; Miller, Randolph A.; Johnson, Kevin B.; Spickard, Anderson

2008-01-01

Clinical documentation is often expressed in natural language text, yet providers often use common organizations that segment these notes in sections, such as “history of present illness” or “physical examination.” We developed a hierarchical section header terminology, supporting mappings to LOINC and other vocabularies; it contained 1109 concepts and 4332 synonyms. Physicians evaluated it compared to LOINC and the Evaluation and Management billing schema using a randomly selected corpus of history and physical notes. Evaluated documents contained a median of 54 sections and 27 “major sections.” There were 16,196 total sections in the evaluation note corpus. The terminology contained 99.9% of the clinical sections; LOINC matched 77% of section header concepts and 20% of section header strings in those documents. The section terminology may enable better clinical note understanding and interoperability. Future development and integration into natural language processing systems is needed. PMID:18999303

Direct and indirect markers of cartilage metabolism in synovial fluid obtained from dogs with hip dysplasia and correlation with clinical and radiographic variables.

PubMed

Fujita, Yukihiro; Hara, Yasushi; Nezu, Yoshinori; Yamaguchi, Shinya; Schulz, Kurt S; Tagawa, Masahiro

2005-12-01

To compare activities of interleukin (IL)-1beta, IL-6, tumor necrosis factor (TNF)-alpha, and matrix metalloproteinase (MMP)-3 and contents of sulfated glycosaminoglycan (S-GAG) in joint fluid obtained from dogs with hip dysplasia (HD) and clinically normal dogs, evaluate correlations among these markers in joint fluid obtained from dogs with HD, and evaluate correlations between each marker and clinical and radiographic variables. Animals-26 dogs with HD (clinical group) and 43 clinically normal Beagles (control group). Joint fluid was aseptically collected from the hip joints of all dogs. For each dog in the clinical group, age, duration of lameness, radiographic osteoarthritis (OA) score, and Norberg angle in each affected joint were recorded. Activities of IL-1beta, IL-6, TNF-alpha, and MMP-3 and S-GAG contents were measured. Values were compared between groups by use of Mann-Whitney U tests, and the Spearman rank correlation test was used to evaluate correlations among markers and between each marker and clinical or radiographic variables. Values of all markers were significantly higher for the clinical group, compared with values for the control group. There was a moderate positive correlation between lameness duration and IL-6 activity and a strong negative correlation between the Norberg angle and IL-1beta activity. Analysis of our results indicated that there was a significant increase in markers of OA in dogs with HD. Activities of IL-1beta and IL-6 in joint fluid of dogs with HD may be influenced by the severity of laxity in the hip joint and lameness duration, respectively.

Evaluating the impact of a pre-rotation workshop on student preparation for clinical advanced pharmacy practice experiences.

PubMed

Medina, Melissa S; Stark, Jennifer E; Vesta, Kimi S; Lockhart, Staci M

2008-10-01

This pilot study was designed to evaluate the impact of a pre-rotation workshop (PRW) on pharmacy students' clinical skills and preparation for clinical Advanced Pharmacy Practice Experiences (APPE) involving direct patient care. Randomized controlled trial of an educational intervention with Institutional Review Board approval. PRW activities designed to simulate rotation activities around five competencies, patient charts, medication histories, SOAP notes, patient presentations, and professionalism. Endpoints were evaluated using clinical rotation preceptors' evaluation of performance and students' performance on objective structured clinical exams (OSCE). Eight fourth-year students and eight GPA matched controls (20% of the total class) were selected to voluntarily participate. The PRW demonstrated a positive impact on students' clinical skills and preparation for rotations by improving OSCE performance. However, no significant differences were found between groups when comparing preceptor evaluations of skills on rotations. These results are limited by the small sample size, potential OSCE "test-wiseness" effects, lack of OSCE evaluator blinding to study groups, potential case specificity effects due to the limited number of cases used on the OSCE and possible lack of sensitivity of the rotation evaluation tool to capture true differences among the experimental and control group participants. The PRW was successful at advancing students' clinical skills and preparation for rotations and may be considered as a tool to help bridge didactic to clinical experiences in the Pharm.D. curriculum.

Short- and long-term clinical outcomes of use of beta-interferon or glatiramer acetate for people with clinically isolated syndrome: a systematic review of randomised controlled trials and network meta-analysis.

PubMed

Armoiry, X; Kan, A; Melendez-Torres, G J; Court, R; Sutcliffe, P; Auguste, P; Madan, J; Counsell, C; Clarke, A

2018-05-01

Beta-interferon (IFN-β) and glatiramer acetate (GA) have been evaluated in people with clinically isolated syndrome (CIS) with the aim to delay a second clinical attack and a diagnosis of clinically definite multiple sclerosis (CDMS). We systematically reviewed trials evaluating the short- and long-term clinical effectiveness of these drugs in CIS. We searched multiple electronic databases. We selected randomised controlled studies (RCTs) conducted in CIS patients and where the interventions were IFN-β and GA. Main outcomes were time to CDMS, and discontinuation due to adverse events (AE). We compared interventions using random-effect network meta-analyses (NMA). We also reported outcomes from long-term open-label extension (OLE) studies. We identified five primary studies. Four had open-label extensions following double-blind periods comparing outcomes between early vs delayed DMT. Short-term clinical results (double-blind period) showed that all drugs delayed CDMS compared to placebo. Indirect comparisons did not suggest superiority of any one active drug over another. We could not undertake a NMA for discontinuation due to AE. Long-term clinical results (OLE studies) showed that the risk of developing CDMS was consistently reduced across studies after early DMT treatment compared to delayed DMT (HR = 0.64, 95% CI 0.55, 0.74). No data supported the benefit of DMTs in reducing the time to, and magnitude of, disability progression. Meta-analyses confirmed that IFN-β and GA delay time to CDMS compared to placebo. In the absence of evidence that early DMTs can reduce disability progression, future research is needed to better identify patients most likely to benefit from long-term DMTs.

Quantitative methods for evaluating the efficacy of thalamic deep brain stimulation in patients with essential tremor.

PubMed

Wastensson, Gunilla; Holmberg, Björn; Johnels, Bo; Barregard, Lars

2013-01-01

Deep brain stimulation (DBS) of the thalamus is a safe and efficient method for treatment of disabling tremor in patient with essential tremor (ET). However, successful tremor suppression after surgery requires careful selection of stimulus parameters. Our aim was to examine the possible use of certain quantitative methods for evaluating the efficacy of thalamic DBS in ET patients in clinical practice, and to compare these methods with traditional clinical tests. We examined 22 patients using the Essential Tremor Rating Scale (ETRS) and quantitative assessment of tremor with the stimulator both activated and deactivated. We used an accelerometer (CATSYS tremor Pen) for quantitative measurement of postural tremor, and a eurythmokinesimeter (EKM) to evaluate kinetic tremor in a rapid pointing task. The efficacy of DBS on tremor suppression was prominent irrespective of the method used. The agreement between clinical rating of postural tremor and tremor intensity as measured by the CATSYS tremor pen was relatively high (rs = 0.74). The agreement between kinetic tremor as assessed by the ETRS and the main outcome variable from the EKM test was low (rs = 0.34). The lack of agreement indicates that the EKM test is not comparable with the clinical test. Quantitative methods, such as the CATSYS tremor pen, could be a useful complement to clinical tremor assessment in evaluating the efficacy of DBS in clinical practice. Future studies should evaluate the precision of these methods and long-term impact on tremor suppression, activities of daily living (ADL) function and quality of life.

The prognostic value of sleep patterns in disorders of consciousness in the sub-acute phase.

PubMed

Arnaldi, Dario; Terzaghi, Michele; Cremascoli, Riccardo; De Carli, Fabrizio; Maggioni, Giorgio; Pistarini, Caterina; Nobili, Flavio; Moglia, Arrigo; Manni, Raffaele

2016-02-01

This study aimed to evaluate, through polysomnographic analysis, the prognostic value of sleep patterns, compared to other prognostic factors, in patients with disorders of consciousness (DOCs) in the sub-acute phase. Twenty-seven patients underwent 24-h polysomnography and clinical evaluation 3.5 ± 2 months after brain injury. Their clinical outcome was assessed 18.5 ± 9.9 months later. Polysomnographic recordings were evaluated using visual and quantitative indexes. A general linear model was applied to identify features able to predict clinical outcome. Clinical status at follow-up was analysed as a function of the baseline clinical status, the interval between brain injury and follow-up evaluation, patient age and gender, the aetiology of the injury, the lesion site, and visual and quantitative sleep indexes. A better clinical outcome was predicted by a visual index indicating the presence of sleep integrity (p=0.0006), a better baseline clinical status (p=0.014), and younger age (p=0.031). Addition of the quantitative sleep index strengthened the prediction. More structured sleep emerged as a valuable predictor of a positive clinical outcome in sub-acute DOC patients, even stronger than established predictors (e.g. age and baseline clinical condition). Both visual and quantitative sleep evaluation could be helpful in predicting clinical outcome in sub-acute DOCs. Copyright © 2015 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Exploring the validity and reliability of a questionnaire for evaluating veterinary clinical teachers' supervisory skills during clinical rotations.

PubMed

Boerboom, T B B; Dolmans, D H J M; Jaarsma, A D C; Muijtjens, A M M; Van Beukelen, P; Scherpbier, A J J A

2011-01-01

Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. We examined the validity and reliability of the Maastricht Clinical Teaching Questionnaire (MCTQ) as an instrument to evaluate individual clinical teachers during short clinical rotations in veterinary education. We examined four sources of validity evidence: (1) Content was examined based on theory of effective learning. (2) Response process was explored in a pilot study. (3) Internal structure was assessed by confirmatory factor analysis using 1086 student evaluations and reliability was examined utilizing generalizability analysis. (4) Relations with other relevant variables were examined by comparing factor scores with other outcomes. Content validity was supported by theory underlying the cognitive apprenticeship model on which the instrument is based. The pilot study resulted in an additional question about supervision time. A five-factor model showed a good fit with the data. Acceptable reliability was achievable with 10-12 questionnaires per teacher. Correlations between the factors and overall teacher judgement were strong. The MCTQ appears to be a valid and reliable instrument to evaluate clinical teachers' performance during short rotations.

Clinical and microbiologic effects of commercially available dentifrice containing aloe vera: a randomized controlled clinical trial.

PubMed

Pradeep, A R; Agarwal, Esha; Naik, Savitha B

2012-06-01

Certain plants used in folk medicine serve as a source of therapeutic agents that have antimicrobial and other multipotential effects. This prospective, randomized, placebo, and positively controlled clinical trial was designed to evaluate the clinical and microbiologic effects of a commercially available dentifrice containing aloe vera on the reduction of plaque and gingival inflammation in patients with gingivitis. Ninety patients diagnosed with chronic generalized gingivitis were selected and randomly divided into three groups: group 1, placebo toothpaste; group 2, toothpaste containing aloe vera; and group 3, toothpaste with polymer and fluoride containing triclosan. Clinical evaluation was undertaken using a gingival index, plaque was assessed using a modification of the Quigley-Hein index, and microbiologic counts were assessed at baseline, 6 weeks, 12 weeks, and 24 weeks. A subjective evaluation was also undertaken by questionnaire. Toothpaste containing aloe vera showed significant improvement in gingival and plaque index scores as well as microbiologic counts compared with placebo dentifrice. These improvements were comparable to those achieved with toothpaste containing triclosan. Toothpaste containing aloe vera may be a useful herbal formulation for chemical plaque control agents and improvement in plaque and gingival status.

Faculty and resident evaluations of medical students on a surgery clerkship correlate poorly with standardized exam scores.

PubMed

Goldstein, Seth D; Lindeman, Brenessa; Colbert-Getz, Jorie; Arbella, Trisha; Dudas, Robert; Lidor, Anne; Sacks, Bethany

2014-02-01

The clinical knowledge of medical students on a surgery clerkship is routinely assessed via subjective evaluations from faculty members and residents. Interpretation of these ratings should ideally be valid and reliable. However, prior literature has questioned the correlation between subjective and objective components when assessing students' clinical knowledge. Retrospective cross-sectional data were collected from medical student records at The Johns Hopkins University School of Medicine from July 2009 through June 2011. Surgical faculty members and residents rated students' clinical knowledge on a 5-point, Likert-type scale. Interrater reliability was assessed using intraclass correlation coefficients for students with ≥4 attending surgeon evaluations (n = 216) and ≥4 resident evaluations (n = 207). Convergent validity was assessed by correlating average evaluation ratings with scores on the National Board of Medical Examiners (NBME) clinical subject examination for surgery. Average resident and attending surgeon ratings were also compared by NBME quartile using analysis of variance. There were high degrees of reliability for resident ratings (intraclass correlation coefficient, .81) and attending surgeon ratings (intraclass correlation coefficient, .76). Resident and attending surgeon ratings shared a moderate degree of variance (19%). However, average resident ratings and average attending surgeon ratings shared a small degree of variance with NBME surgery examination scores (ρ(2) ≤ .09). When ratings were compared among NBME quartile groups, the only significant difference was for residents' ratings of students with the lower 25th percentile of scores compared with the top 25th percentile of scores (P = .007). Although high interrater reliability suggests that attending surgeons and residents rate students with consistency, the lack of convergent validity suggests that these ratings may not be reflective of actual clinical knowledge. Both faculty members and residents may benefit from training in knowledge assessment, which will likely increase opportunities to recognize deficiencies and make student evaluation a more valuable tool. Copyright © 2014 Elsevier Inc. All rights reserved.

Evaluation of image features and classification methods for Barrett's cancer detection using VLE imaging

NASA Astrophysics Data System (ADS)

Klomp, Sander; van der Sommen, Fons; Swager, Anne-Fré; Zinger, Svitlana; Schoon, Erik J.; Curvers, Wouter L.; Bergman, Jacques J.; de With, Peter H. N.

2017-03-01

Volumetric Laser Endomicroscopy (VLE) is a promising technique for the detection of early neoplasia in Barrett's Esophagus (BE). VLE generates hundreds of high resolution, grayscale, cross-sectional images of the esophagus. However, at present, classifying these images is a time consuming and cumbersome effort performed by an expert using a clinical prediction model. This paper explores the feasibility of using computer vision techniques to accurately predict the presence of dysplastic tissue in VLE BE images. Our contribution is threefold. First, a benchmarking is performed for widely applied machine learning techniques and feature extraction methods. Second, three new features based on the clinical detection model are proposed, having superior classification accuracy and speed, compared to earlier work. Third, we evaluate automated parameter tuning by applying simple grid search and feature selection methods. The results are evaluated on a clinically validated dataset of 30 dysplastic and 30 non-dysplastic VLE images. Optimal classification accuracy is obtained by applying a support vector machine and using our modified Haralick features and optimal image cropping, obtaining an area under the receiver operating characteristic of 0.95 compared to the clinical prediction model at 0.81. Optimal execution time is achieved using a proposed mean and median feature, which is extracted at least factor 2.5 faster than alternative features with comparable performance.

Clinical evaluation of GEM 21S® and a collagen membrane with a coronally advanced flap as a root coverage procedure in the treatment of gingival recession defects: A comparative study

PubMed Central

Singh, Preetinder; Suresh, D. K.

2012-01-01

Aim: Clinical evaluation of efficacy of rhPDGF-BB plus beta tricalcium phosphate (GEM 21S®) along with a collagen membrane in root coverage using a coronally advanced flap. Materials and Methods: This human case series evaluated the clinical outcome of rhPDGF-BB with beta-tricalcium phosphate (GEM 21S®) and a collagen membrane in the treatment of recession defects using a coronally advanced flap. Patients were followed postoperatively, and healing was evaluated at 1, 3, and 6 months, with recession depth as the primary outcome measure. Results: This pioneer case series revealed a favorable tissue response to GEM 21S® and collagen membrane from both clinical and esthetic point of view in regenerative periodontal surgery. PMID:23493720

Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial.

PubMed

Frakking, Thuy T; Chang, Anne B; O'Grady, Kerry-Ann F; Walker-Smith, Katie; Weir, Kelly A

2013-11-07

Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of 'CFE + CA' versus 'CFE' only compared to MBS-identified OPA. Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility of CA in assessing and diagnosing OPA risk in young children. Australia and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12613000589785.

Cervical auscultation in the diagnosis of oropharyngeal aspiration in children: a study protocol for a randomised controlled trial

PubMed Central

2013-01-01

Background Oropharyngeal aspiration (OPA) can lead to recurrent respiratory illnesses and chronic lung disease in children. Current clinical feeding evaluations performed by speech pathologists have poor reliability in detecting OPA when compared to radiological procedures such as the modified barium swallow (MBS). Improved ability to diagnose OPA accurately via clinical evaluation potentially reduces reliance on expensive, less readily available radiological procedures. Our study investigates the utility of adding cervical auscultation (CA), a technique of listening to swallowing sounds, in improving the diagnostic accuracy of a clinical evaluation for the detection of OPA. Methods We plan an open, unblinded, randomised controlled trial at a paediatric tertiary teaching hospital. Two hundred and sixteen children fulfilling the inclusion criteria will be randomised to one of the two clinical assessment techniques for the clinical detection of OPA: (1) clinical feeding evaluation only (CFE) group or (2) clinical feeding evaluation with cervical auscultation (CFE + CA) group. All children will then undergo an MBS to determine radiologically assessed OPA. The primary outcome is the presence or absence of OPA, as determined on MBS using the Penetration-Aspiration Scale. Our main objective is to determine the sensitivity, specificity, negative and positive predictive values of ‘CFE + CA’ versus ‘CFE’ only compared to MBS-identified OPA. Discussion Early detection and appropriate management of OPA is important to prevent chronic pulmonary disease and poor growth in children. As the reliability of CFE to detect OPA is low, a technique that can improve the diagnostic accuracy of the CFE will help minimise consequences to the paediatric respiratory system. Cervical auscultation is a technique that has previously been documented as a clinical adjunct to the CFE; however, no published RCTs addressing the reliability of this technique in children exist. Our study will be the first to establish the utility of CA in assessing and diagnosing OPA risk in young children. Trial registration Australia and New Zealand Clinical Trials Register (ANZCTR) number ACTRN12613000589785. PMID:24199872

SU-G-201-09: Evaluation of a Novel Machine-Learning Algorithm for Permanent Prostate Brachytherapy Treatment Planning

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

Nicolae, A; Department of Physics, Ryerson University, Toronto, ON; Lu, L

Purpose: A novel, automated, algorithm for permanent prostate brachytherapy (PPB) treatment planning has been developed. The novel approach uses machine-learning (ML), a form of artificial intelligence, to substantially decrease planning time while simultaneously retaining the clinical intuition of plans created by radiation oncologists. This study seeks to compare the ML algorithm against expert-planned PPB plans to evaluate the equivalency of dosimetric and clinical plan quality. Methods: Plan features were computed from historical high-quality PPB treatments (N = 100) and stored in a relational database (RDB). The ML algorithm matched new PPB features to a highly similar case in the RDB;more » this initial plan configuration was then further optimized using a stochastic search algorithm. PPB pre-plans (N = 30) generated using the ML algorithm were compared to plan variants created by an expert dosimetrist (RT), and radiation oncologist (MD). Planning time and pre-plan dosimetry were evaluated using a one-way Student’s t-test and ANOVA, respectively (significance level = 0.05). Clinical implant quality was evaluated by expert PPB radiation oncologists as part of a qualitative study. Results: Average planning time was 0.44 ± 0.42 min compared to 17.88 ± 8.76 min for the ML algorithm and RT, respectively, a significant advantage [t(9), p = 0.01]. A post-hoc ANOVA [F(2,87) = 6.59, p = 0.002] using Tukey-Kramer criteria showed a significantly lower mean prostate V150% for the ML plans (52.9%) compared to the RT (57.3%), and MD (56.2%) plans. Preliminary qualitative study results indicate comparable clinical implant quality between RT and ML plans with a trend towards preference for ML plans. Conclusion: PPB pre-treatment plans highly comparable to those of an expert radiation oncologist can be created using a novel ML planning model. The use of an ML-based planning approach is expected to translate into improved PPB accessibility and plan uniformity.« less

1-year clinical outcomes of diabetic patients treated with everolimus-eluting bioresorbable vascular scaffolds: a pooled analysis of the ABSORB and the SPIRIT trials.

PubMed

Muramatsu, Takashi; Onuma, Yoshinobu; van Geuns, Robert-Jan; Chevalier, Bernard; Patel, Tejas M; Seth, Ashok; Diletti, Roberto; García-García, Hector M; Dorange, Cécile C; Veldhof, Susan; Cheong, Wai-Fung; Ozaki, Yukio; Whitbourn, Robert; Bartorelli, Antonio; Stone, Gregg W; Abizaid, Alexandre; Serruys, Patrick W

2014-05-01

The aim of this study was to evaluate 1-year clinical outcomes of diabetic patients treated with the Absorb bioresorbable vascular scaffold (BVS). Clinical outcomes of diabetic patients after BVS implantation have been unreported. This study included 101 patients in the ABSORB Cohort B trial and the first consecutive 450 patients with 1 year of follow-up in the ABSORB EXTEND trial. A total of 136 diabetic patients were compared with 415 nondiabetic patients. In addition, 882 diabetic patients treated with everolimus-eluting metal stents (EES) in pooled data from the SPIRIT trials (SPIRIT FIRST [Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT II [A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System], SPIRIT III [Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System (EECSS)], SPIRIT IV Clinical Trial [Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System]) were used for the comparison by applying propensity score matching. The primary endpoint was a device-oriented composite endpoint (DoCE), including cardiac death, target vessel myocardial infarction, and target lesion revascularization at 1-year follow-up. The cumulative incidence of DoCE did not differ between diabetic and nondiabetic patients treated with the BVS (3.7% vs. 5.1%, p = 0.64). Diabetic patients treated with the BVS had a similar incidence of the DoCE compared with diabetic patients treated with EES in the matched study group (3.9% for the BVS vs. 6.4% for EES, p = 0.38). There were no differences in the incidence of definite or probable scaffold/stent thrombosis (0.7% for both diabetic and nondiabetic patients with the BVS; 1.0% for diabetic patients with the BVS vs. 1.7% for diabetic patients with EES in the matched study group). In the present analyses, diabetic patients treated with the BVS showed similar rates of DoCEs compared with nondiabetic patients treated with the BVS and diabetic patients treated with EES at 1-year follow-up. (ABSORB Clinical Investigation, Cohort B; NCT00856856; ABSORB EXTEND Clinical Investigation; NCT01023789; Clinical Trial of the Abbott Vascular XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT FIRST]; NCT00180453; A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT II]; NCT00180310; Clinical Trial of the XIENCE V Everolimus Eluting Coronary Stent System [EECSS] [SPIRIT III]; NCT00180479; Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System [SPIRIT IV Clinical Trial]; NCT00307047). Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

The use of medical quality indices as a performance-enhancement tool for community clinics.

PubMed

Elhayany, A

2001-12-01

One of the most important issues for a country, its population and doctors is the effective use of its health system. The extensive variation in doctors' performance leads to a tremendous waste of resources. To combat this, and at the same time ensure that medical quality plays a role when making decisions on interventions, it is essential to equip doctors and clinic directors with information on the quality of the medical care they are providing. In order to assist clinic directors in maintaining medical quality, Clalit Health Services has developed comparative medical indices enabling doctors to compare their performance to that of their colleagues, as well as to the standard and their performance over time. The development of an index to evaluate the quality of medical treatment offered in clinics provides doctors and the health system with an essential tool to lessen the existing variation among doctors and to enhance and evaluate performance.

Implementation of an Oxytocin Checklist to Improve Clinical Outcomes.

PubMed

Sundin, Courtney; Mazac, Lauren; Ellis, Kathleen; Garbo, Candon

Oxytocin is one of the most common drugs administered in obstetrics. Since its designation as a high-alert medication by the Institute for Safe Medication Practices in 2007, there has been much attention to oxytocin administration during labor. Oxytocin is generally safe when administered correctly, but adverse perinatal outcomes can occur during uterine tachysystole. The purpose of this project was to evaluate and compare results of maternal and fetal outcomes of induction of labor for women at term prior to and after implementation of a newly developed oxytocin checklist. To evaluate the practice change associated with the implementation of the new oxytocin checklist, 200 cases based on retrospective medical record reviews were compared with 200 cases after implementation. Use of the checklist was associated with several significant clinical outcomes, including decreases in tachysystole, decreases in cesarean births for concern about fetal status based on electronic fetal monitoring data, decreases in length of first stage labor, and decreases in maximum dose of oxytocin. Results are similar to previous research. Early physician buy-in, clinical team education, and ongoing evaluation enhanced facilitation of the oxytocin checklist. Clinical outcomes were favorable.

Detecting clinically relevant new information in clinical notes across specialties and settings.

PubMed

Zhang, Rui; Pakhomov, Serguei V S; Arsoniadis, Elliot G; Lee, Janet T; Wang, Yan; Melton, Genevieve B

2017-07-05

Automated methods for identifying clinically relevant new versus redundant information in electronic health record (EHR) clinical notes is useful for clinicians and researchers involved in patient care and clinical research, respectively. We evaluated methods to automatically identify clinically relevant new information in clinical notes, and compared the quantity of redundant information across specialties and clinical settings. Statistical language models augmented with semantic similarity measures were evaluated as a means to detect and quantify clinically relevant new and redundant information over longitudinal clinical notes for a given patient. A corpus of 591 progress notes over 40 inpatient admissions was annotated for new information longitudinally by physicians to generate a reference standard. Note redundancy between various specialties was evaluated on 71,021 outpatient notes and 64,695 inpatient notes from 500 solid organ transplant patients (April 2015 through August 2015). Our best method achieved at best performance of 0.87 recall, 0.62 precision, and 0.72 F-measure. Addition of semantic similarity metrics compared to baseline improved recall but otherwise resulted in similar performance. While outpatient and inpatient notes had relatively similar levels of high redundancy (61% and 68%, respectively), redundancy differed by author specialty with mean redundancy of 75%, 66%, 57%, and 55% observed in pediatric, internal medicine, psychiatry and surgical notes, respectively. Automated techniques with statistical language models for detecting redundant versus clinically relevant new information in clinical notes do not improve with the addition of semantic similarity measures. While levels of redundancy seem relatively similar in the inpatient and ambulatory settings in the Fairview Health Services, clinical note redundancy appears to vary significantly with different medical specialties.

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Effect of 1% sodium alendronate in the non-surgical treatment of periodontal intraosseous defects: a 6-month clinical trial

PubMed Central

DUTRA, Bernardo Carvalho; OLIVEIRA, Alcione Maria Soares Dutra; OLIVEIRA, Peterson Antônio Dutra; MANZI, Flavio Ricardo; CORTELLI, Sheila Cavalca; COTA, Luís Otávio de Miranda; COSTA, Fernando Oliveira

2017-01-01

Abstract Background and objectives Few studies have evaluated the effect of the topical application of sodium alendronate (ALN) on the treatment of intrabuccal bone defects, especially those caused by periodontitis. This 6-month randomized placebo controlled clinical trial aimed at evaluating the effect of non-surgical periodontal treatment associated with the use of 1% ALN, through clinical evaluations and cone-beam computed tomography (CBCT). Material and Methods Twenty individuals with chronic periodontitis underwent periodontal examination at the baseline as well as 3 and 6 months after periodontal treatment, registering clinical attachment level (CAL), periodontal probing depth (PPD), and bleeding on probing (BOP) as the clinical outcomes. After manual scaling and root planing, 40 bilateral sites with interproximal vertical bone defects were randomly treated with either 1% ALN gel or a placebo. Bone defects were evaluated through CBCT at the baseline and 6 months post-treatment. The clinical and CBCT parameters were compared using the Wilcoxon and Friedman tests (p<0.05). Results Although ALN produced a greater CAL gain when compared to the placebo at 6 months post-treatment (p=0.021), both treatments produced similar effects on the PPD, BOP, and bone height. Significant differences in bone fill were observed only in patients of the ALN group (4.5 to 3.8 mm; p=0.003) at 6 months post-treatment. Conclusions Topical application of 1% ALN might be a beneficial adjuvant to non-surgical periodontal therapy. PMID:28678950

[Virus detection, clinical signs, and laboratory findings in dogs with acute hemorrhagic diarrhea: a retrospective study of 935 cases].

PubMed

Kempf, C; Schulz, B S; Strauch, C; Sauter-Louis, C; Truyen, U; Hartmann, K

2010-01-01

The study evaluated which viruses can be detected in dogs with acute hemorrhagic diarrhea and compared signalment, clinical signs, and laboratory abnormalities among groups of dogs infected with different viruses and those that tested virus-negative. Fecal samples from 935 dogs with acute hemorrhagic diarrhea were examined by electron microscopy. The medical records of these patients were retrospectively evaluated for clinical and laboratory parameters. Virus was detected in 44.2% of the dogs presented with acute bloody diarrhea. The highest prevalence for a virus infection was demonstrated for canine parvovirus (19.9%), followed by coronavirus (17.3%), and paramyxovirus (13.9%). More than one virus species was detected in 6.5% of all fecal samples. Dogs with a virus-positive fecal sample were significantly younger than dogs that tested negative on electron microscopy. Among virus-positive dogs, dogs with parvovirus infection were significantly younger when compared to dogs infected with other enteric viruses. Parvovirus-infected patients also showed significantly lower leukocyte and erythrocyte counts as well as hematocrit, total protein, and albumin levels compared to all other groups. No significant differences were seen when evaluating sex, clinical parameters, character of diarrhea or vomiting among all groups. Young dogs are more likely to suffer from viral enteritis. Based on clinical parameters it is not possible to differentiate a virus-positive from a virus-negative dog or to diagnose a certain virus species. Besides the young age, parvovirus infection is associated with typical changes in laboratory parameters, but not with specific clinical signs. A virologic fecal examination is always indicated.

Different manifestation of depressive disorder in the elderly.

PubMed

Shahpesandy, Homayun

2005-12-01

To compare the clinical manifestation of depressive disorder in elderly, and younger adults. To compare the clinical manifestation of depressive disorder, we evaluate 46 elderly (33 female, and 13 male, mean age 71.1) and 60 younger adults (40 female, and 20 male, mean age 44.5 years). All patients suffering from depressive disorders according to ICD-10. For evaluation and comparison of depressive symptomatology we used the HAM-D-17. The results analysed by the SPSS. The clinical manifestation of depression is different in the elderly. Elderly depressed patients compared with their younger counterparts, scored significantly less in Depressed mood, but significantly higher in Work and activities, Retardation, Somatic symptoms-general, Hypochondriasis, Insomnia-middle, Insomnia-late, Anxiety-somatic, and Somatic symptoms-gastrointestinal. On the other hand, younger patients scored significantly higher in Feelings of guilt, and Genital symptoms. Clinical presentation of depressive disorder is different in the elderly, depressed mood is often absent or masked. Anxiety, somatization, and hypochondriasis are more often present in the elderly depressed patients than in younger patients. The elderly people are also more likely than their younger counterparts to complain of insomnia.

[Assessment of the correlation between histological degeneration and radiological and clinical parameters in a series of patients who underwent lumbar disc herniation surgery].

PubMed

Munarriz, Pablo M; Paredes, Igor; Alén, José F; Castaño-Leon, Ana M; Cepeda, Santiago; Hernandez-Lain, Aurelio; Lagares, Alfonso

The use of histological degeneration scores in surgically-treated herniated lumbar discs is not common in clinical practice and its use has been primarily restricted to research. The objective of this study is to evaluate if there is an association between a higher grade of histological degeneration when compared with clinical or radiological parameters. Retrospective consecutive analysis of 122 patients who underwent single-segment lumbar disc herniation surgery. Clinical information was available on all patients, while the histological study and preoperative magnetic resonance imaging were also retrieved for 75 patients. Clinical variables included age, duration of symptoms, neurological deficits, or affected deep tendon reflex. The preoperative magnetic resonance imaging was evaluated using Modic and Pfirrmann scores for the affected segment by 2 independent observers. Histological degeneration was evaluated using Weiler's score; the presence of inflammatory infiltrates and neovascularization, not included in the score, were also studied. Correlation and chi-square tests were used to assess the association between histological variables and clinical or radiological variables. Interobserver agreement was also evaluated for the MRI variables using weighted kappa. No statistically significant correlation was found between histological variables (histological degeneration score, inflammatory infiltrates or neovascularization) and clinical or radiological variables. Interobserver agreement for radiological scores resulted in a kappa of 0.79 for the Pfirrmann scale and 0.65 for the Modic scale, both statistically significant. In our series of patients, we could not demonstrate any correlation between the degree of histological degeneration or the presence of inflammatory infiltrates when compared with radiological degeneration scales or clinical variables such as the patient's age or duration of symptoms. Copyright © 2017 Sociedad Española de Neurocirugía. Publicado por Elsevier España, S.L.U. All rights reserved.

Role of mixed ion channel effects in the cardiovascular safety assessment of the novel anti-MRSA fluoroquinolone JNJ-Q2.

PubMed

Eichenbaum, G; Pugsley, M K; Gallacher, D J; Towart, R; McIntyre, G; Shukla, U; Davenport, J M; Lu, H R; Rohrbacher, J; Hillsamer, V

2012-07-01

JNJ-Q2, a novel broad-spectrum fluoroquinolone with anti-methicillin-resistant Staphylococcus aureus activity, was evaluated in a comprehensive set of non-clinical and clinical cardiovascular safety studies. The effect of JNJ-Q2 on different cardiovascular parameters was compared with that of moxifloxacin, sparfloxacin and ofloxacin. Through comparisons with these well-known fluoroquinolones, the importance of effects on compensatory ion channels to the cardiovascular safety of JNJ-Q2 was investigated. JNJ-Q2 and comparator fluoroquinolones were evaluated in the following models/test systems: hERG-transfected HEK293 cells sodium channel-transfected CHO cells, guinea pig right atria, arterially perfused rabbit left ventricular wedge preparations and in vivo studies in anaesthetized guinea pigs, anaesthetized and conscious telemetered dogs, and a thorough QT study in humans. The trend for effects of JNJ-Q2 on Tp-Te, QT, QRS and PR intervals in the non-clinical models and the plateau in QTc with increasing plasma concentration in humans are consistent with offsetting sodium and calcium channel activities that were observed in the non-clinical studies. These mixed ion channel activities result in the less pronounced or comparable increase in QTc interval for JNJ-Q2 compared with moxifloxacin and sparfloxacin despite its greater in vitro inhibition of I(Kr). Based on the non-clinical and clinical cardiovascular safety assessment, JNJ-Q2 has a safe cardiovascular profile for administration in humans with comparable or reduced potential to prolong QT intervals, compared with moxifloxacin. The results demonstrate the importance of compensatory sodium and calcium channel activity in offsetting potassium channel activity for compounds with a fluoroquinolone core. © 2012 Janssen Pharmaceutical Companies of Johnson & Johnson. British Journal of Pharmacology © 2012 The British Pharmacological Society.

Evaluation of a rebound tonometer (Tonovet) in clinically normal cat eyes.

PubMed

Rusanen, Elina; Florin, Marion; Hässig, Michael; Spiess, Bernhard M

2010-01-01

To determine the accuracy of and to establish reference values for a rebound tonometer (Tonovet) in normal feline eyes, to compare it with an applanation tonometer (Tonopen Vet) and to evaluate the effect of topical anesthesia on rebound tonometry. Six enucleated eyes were used to compare both tonometers with direct manometry. Intraocular pressure (IOP) was measured in 100 cats to establish reference values for rebound tonometry. Of these, 22 cats were used to compare rebound tonometry with and without topical anesthesia and 33 cats to compare the rebound and applanation tonometers. All evaluated eyes were free of ocular disease. Both tonometers correlated well with direct manometry. The best agreement with the rebound tonometer was achieved between 25-50 mmHg. The applanation tonometer was accurate at pressures between 0 and 30 mmHg. The mean IOP in clinically normal cats was 20.74 mmHg with the rebound tonometer and 18.4 mmHg with the applanation tonometer. Topical anesthesia did not significantly affect rebound tonometry. As the rebound tonometer correlated well with direct manometry in the clinically important pressure range and was well tolerated by cats, it appears suitable for glaucoma diagnosis. The mean IOP obtained with the rebound tonometer was 2-3 mmHg higher than that measured with the applanation tonometer. This difference is within clinically acceptable limits, but indicates that the same type of tonometer should be used in follow-up examinations in a given cat.

Curriculum gaps in teaching clinical skills to Iranian undergraduate medical students.

PubMed

Mirzazadeh, Azim; Bavarian, Behrouz; Labaf, Ali; Afshari, Ali; Nikoo, Mohammad; Meshkani, Zahra Sadat; Khashayar, Patricia

2013-04-20

The inefficacy of clinical skill education during the clerkship has been reported in several studies. The present study was conducted to evaluate the competency of medical students in performing several clinical skills through an Objective Structured Clinical Examination (OSCE), aiming to evaluate the quality of the existing curriculum in the clerkship phase. The cross sectional study was conducted at the end of the clerkship period, before the students had entered the internship. The OSCE exam was conducted in the morning (2 different tracts) and in the evening (2 similar tracts) and 86 students participated in the exam. Each tract consisted of seven stations. The students' points in the stations assessing history taking and clinical skills were compared. The students gained the highest points in the history taking stations, whereas the procedure stations accounted for the lowest points; there was a significant difference between these stations (p < 0.001). The female students achieved higher scores in the OSCE exam compared to males (p = 0.004). The OSCE exam revealed the inefficacy of the current medical curriculum in teaching the required clinical skill to undergraduate medical students during the clerkship.

MARIA M4: clinical evaluation of a prototype ultrawideband radar scanner for breast cancer detection

PubMed Central

Preece, Alan W.; Craddock, Ian; Shere, Mike; Jones, Lyn; Winton, Helen L.

2016-01-01

Abstract. A microwave imaging system has been developed as a clinical diagnostic tool operating in the 3- to 8-GHz region using multistatic data collection. A total of 86 patients recruited from a symptomatic breast care clinic were scanned with a prototype design. The resultant three-dimensional images have been compared “blind” with available ultrasound and mammogram images to determine the detection rate. Images show the location of the strongest signal, and this corresponded in both older and younger women, with sensitivity of >74%, which was found to be maintained in dense breasts. The pathway from clinical prototype to clinical evaluation is outlined. PMID:27446970

Evaluation of a filmed clinical scenario as a teaching resource for an introductory pharmacology unit for undergraduate health students: A pilot study.

PubMed

East, Leah; Hutchinson, Marie

2015-12-01

Simulation is frequently being used as a learning and teaching resource for both undergraduate and postgraduate students, however reporting of the effectiveness of simulation particularly within the pharmacology context is scant. The aim of this pilot study was to evaluate a filmed simulated pharmacological clinical scenario as a teaching resource in an undergraduate pharmacological unit. Pilot cross-sectional quantitative survey. An Australian university. 32 undergraduate students completing a healthcare degree including nursing, midwifery, clinical science, health science, naturopathy, and osteopathy. As a part of an undergraduate online pharmacology unit, students were required to watch a filmed simulated pharmacological clinical scenario. To evaluate student learning, a measurement instrument developed from Bloom's cognitive domains (knowledge, comprehension, application, analysis, synthesis and evaluation) was employed to assess pharmacological knowledge conceptualisation and knowledge application within the following fields: medication errors; medication adverse effects; medication interactions; and, general pharmacology. The majority of participants were enrolled in an undergraduate nursing or midwifery programme (72%). Results demonstrated that the majority of nursing and midwifery students (56.52%) found the teaching resource complementary or more useful compared to a lecture although less so compared to a tutorial. Students' self-assessment of learning according to Bloom's cognitive domains indicated that the filmed scenario was a valuable learning tool. Analysis of variance indicated that health science students reported higher levels of learning compared to midwifery and nursing. Students' self-report of the learning benefits of a filmed simulated clinical scenario as a teaching resource suggest enhanced critical thinking skills and knowledge conceptualisation regarding pharmacology, in addition to being useful and complementary to other teaching and learning methods. Copyright © 2015 Elsevier Ltd. All rights reserved.

[Comparison of participative educative strategy versus traditional educative strategy in health personnel].

PubMed

Barrera de León, Juan Carlos; Barajas-Serrano, Tanya Lizbeth; Jiménez-Hernández, Jacive Elizabeth; Barrera-López, Efrén; González-Bernal, Cesáreo; Higareda-Almaraz, Martha Alicia

2015-01-01

To compare the clinical aptitude in neonatal resuscitation with participative educative strategy versus traditional educative strategy in health personnel. Quasi-experimental study design including physicians and nurses distributed in two groups: (i) participative educative strategies n=156, and (ii) traditional n=158, were imparted in 12 sessions. Evaluation of clinical aptitude evaluated with validated questionnaire. Descriptive and interferential statistical inter- and intragroup. Clinical aptitude median score before/after: participative educative strategy 25.0/36.5 (p=0.000) and traditional 24.5/31.0 (p=0.000); differences between intergroup p=0.040. Changes to higher category according to the score before/after in participative 114 (73%) vs. traditional 65 (41%); p=0.010. There were no significant differences in the intergroup results in the category of evaluation of clinical aptitude, but there were differences in the intragroup when we evaluated median before and after with both strategies. Increase of clinical aptitude in neonatal resuscitation in health personnel,with both educative strategies being higher with participative strategy.

Clinical evaluation of the new Roche platform of serological and molecular cytomegalovirus-specific assays in the diagnosis and prognosis of congenital cytomegalovirus infection.

PubMed

Chiereghin, Angela; Pavia, Claudia; Gabrielli, Liliana; Piccirilli, Giulia; Squarzoni, Diego; Turello, Gabriele; Gibertoni, Dino; Simonazzi, Giuliana; Capretti, Maria Grazia; Lanari, Marcello; Lazzarotto, Tiziana

2017-10-01

Clinical evaluation of the Elecsys ® CMV IgM, IgG, IgG Avidity and COBAS AmpliPrep/COBAS TaqMan CMV (COBAS CMV) assays (Roche Diagnostics AG) in the diagnosis and prognosis of congenital CMV infection was performed. In this study, 150 preselected clinical samples (50 primary infection sera, 50 amniotic fluid [AF] and 50 newborn urine) were processed using Roche serological/molecular CMV-specific tests. Results were compared with those obtained by routine assays (comparator assays). The Elecsys ® CMV IgM and IgG assays showed a perfect agreement (100%) with the comparator assays. Using the combination of the Elecsys ® CMV IgM and IgG Avidity assays results, a primary infection was identified in 100% of cases. Inappropriate avidity CMV IgG values in two samples with very low IgG values (<6 AU/mL) were observed. COBAS CMV assay showed an agreement equal to 98% and 100% with comparator assays by processing AF and urine samples, respectively. Among AF with quantitative results, Lin's concordance correlation was 0.933 and comparator-COBAS CMV assays gave CMV-DNA loads differing by <0.5 log 10 DNA. Finally, higher CMV-DNA levels in AF samples were associated with a symptomatic outcome (p=0.003). The Roche CMV-specific assays compared well with the comparator assays, thus providing to be suitable for clinical use. Copyright © 2017 Elsevier B.V. All rights reserved.

[Comparison between administrative and clinical databases in the evaluation of cardiac surgery performance].

PubMed

Rosato, Stefano; D'Errigo, Paola; Badoni, Gabriella; Fusco, Danilo; Perucci, Carlo A; Seccareccia, Fulvia

2008-08-01

The availability of two contemporary sources of information about coronary artery bypass graft (CABG) interventions, allowed 1) to verify the feasibility of performing outcome evaluation studies using administrative data sources, and 2) to compare hospital performance obtainable using the CABG Project clinical database with hospital performance derived from the use of current administrative data. Interventions recorded in the CABG Project were linked to the hospital discharge record (HDR) administrative database. Only the linked records were considered for subsequent analyses (46% of the total CABG Project). A new selected population "clinical card-HDR" was then defined. Two independent risk-adjustment models were applied, each of them using information derived from one of the two different sources. Then, HDR information was supplemented with some patient preoperative conditions from the CABG clinical database. The two models were compared in terms of their adaptability to data. Hospital performances identified by the two different models and significantly different from the mean was compared. In only 4 of the 13 hospitals considered for analysis, the results obtained using the HDR model did not completely overlap with those obtained by the CABG model. When comparing statistical parameters of the HDR model and the HDR model + patient preoperative conditions, the latter showed the best adaptability to data. In this "clinical card-HDR" population, hospital performance assessment obtained using information from the clinical database is similar to that derived from the use of current administrative data. However, when risk-adjustment models built on administrative databases are supplemented with a few clinical variables, their statistical parameters improve and hospital performance assessment becomes more accurate.

Comparison of methods for quantitative evaluation of endoscopic distortion

NASA Astrophysics Data System (ADS)

Wang, Quanzeng; Castro, Kurt; Desai, Viraj N.; Cheng, Wei-Chung; Pfefer, Joshua

2015-03-01

Endoscopy is a well-established paradigm in medical imaging, and emerging endoscopic technologies such as high resolution, capsule and disposable endoscopes promise significant improvements in effectiveness, as well as patient safety and acceptance of endoscopy. However, the field lacks practical standardized test methods to evaluate key optical performance characteristics (OPCs), in particular the geometric distortion caused by fisheye lens effects in clinical endoscopic systems. As a result, it has been difficult to evaluate an endoscope's image quality or assess its changes over time. The goal of this work was to identify optimal techniques for objective, quantitative characterization of distortion that are effective and not burdensome. Specifically, distortion measurements from a commercially available distortion evaluation/correction software package were compared with a custom algorithm based on a local magnification (ML) approach. Measurements were performed using a clinical gastroscope to image square grid targets. Recorded images were analyzed with the ML approach and the commercial software where the results were used to obtain corrected images. Corrected images based on the ML approach and the software were compared. The study showed that the ML method could assess distortion patterns more accurately than the commercial software. Overall, the development of standardized test methods for characterizing distortion and other OPCs will facilitate development, clinical translation, manufacturing quality and assurance of performance during clinical use of endoscopic technologies.

Benefit-risk Evaluation for Diagnostics: A Framework (BED-FRAME).

PubMed

Evans, Scott R; Pennello, Gene; Pantoja-Galicia, Norberto; Jiang, Hongyu; Hujer, Andrea M; Hujer, Kristine M; Manca, Claudia; Hill, Carol; Jacobs, Michael R; Chen, Liang; Patel, Robin; Kreiswirth, Barry N; Bonomo, Robert A

2016-09-15

The medical community needs systematic and pragmatic approaches for evaluating the benefit-risk trade-offs of diagnostics that assist in medical decision making. Benefit-Risk Evaluation of Diagnostics: A Framework (BED-FRAME) is a strategy for pragmatic evaluation of diagnostics designed to supplement traditional approaches. BED-FRAME evaluates diagnostic yield and addresses 2 key issues: (1) that diagnostic yield depends on prevalence, and (2) that different diagnostic errors carry different clinical consequences. As such, evaluating and comparing diagnostics depends on prevalence and the relative importance of potential errors. BED-FRAME provides a tool for communicating the expected clinical impact of diagnostic application and the expected trade-offs of diagnostic alternatives. BED-FRAME is a useful fundamental supplement to the standard analysis of diagnostic studies that will aid in clinical decision making. © 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.

The impact of rheologically controlled materials on the identification of airway compromise on the clinical and videofluoroscopic swallowing examinations.

PubMed

Groher, Michael E; Crary, Michael A; Carnaby Mann, Giselle; Vickers, Zata; Aguilar, Carlos

2006-10-01

Numerous studies have suggested that the clinical evaluation of swallowing fails to adequately identify those patients who aspirate or do not aspirate on a videofluoroscopic swallowing examination. These conclusions, however, are based on comparisons between swallowed materials that were not rheologically matched. The present study used a battery of rheologically matched test materials, involving thin and thick liquids and cohesive and adhesive semisolids. Using these test items, results from a clinical swallow evaluation were compared to the results of a videofluorographic evaluation using identical test materials. Results suggest that the use of three test materials, including thin and thick liquids given in volumes of 5 and 10 ml, demonstrated the strongest associations between cough on the clinical examination and aspiration on the videofluoroscopic examination.

[Emotional climate and internal communication in a clinical management unit compared with two traditional hospital services].

PubMed

Alonso, E; Rubio, A; March, J C; Danet, A

2011-01-01

The aim of this study is to compare the emotional climate, quality of communication and performance indicators in a clinical management unit and two traditional hospital services. Quantitative study. questionnaire of 94 questions. 83 health professionals (63 responders) from the clinical management unit of breast pathology and the hospital services of medical oncology and radiation oncology. descriptive statistics, comparison of means, correlation and linear regression models. The clinical management unit reaches higher values compared with the hospital services about: performance indicators, emotional climate, internal communication and evaluation of the leadership. An important gap between existing and desired sources, channels, media and subjects of communication appear, in both clinical management unit and traditional services. The clinical management organization promotes better internal communication and interpersonal relations, leading to improved performance indicators. Copyright © 2011 SECA. Published by Elsevier Espana. All rights reserved.

76 FR 10367 - Agency Information Collection Request; 60-Day Public Comment Request

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-24

.... Proposed Project: Research Evaluation and Impact Assessment of ARRA Comparative Effectiveness Research... under real-world conditions in diverse populations and clinical practice settings, that is, comparative... Coordinating Council on Comparative Effectiveness Research (FCCCER) to help coordinate and minimize duplicative...

Gluteus maximus impairment in femoroacetabular impingement: a tensiomyographic evaluation of a clinical fact.

PubMed

Seijas, Roberto; Alentorn-Geli, Eduard; Álvarez-Díaz, Pedro; Marín, Miguel; Ares, Oscar; Sallent, Andrea; Cuscó, Xavier; Cugat, Ramón

2016-06-01

the aim of the present study is to evaluate the mechanical and contractile properties of the gluteus maximus (GM) muscle in patients with femoroacetabular impingement (FAI). Our hypothesis is that the clinical observation of GM pain would be evidenced by tensiomyographic impairment in muscle function. A prospective, cross-sectional, intra-group comparative study was conducted to assess the neuromuscular changes of lower extremity muscles in patients with FAI. Fifty-one patients with clinical and radiographic diagnosis of FAI for at least 3 months were included. The rectus femoris (RF), adductor magnus (AM), and GM of both lower extremities of all patients were evaluated with tensiomyography (TMG). The values of TMG of the affected lower extremity were compared to those of the healthy contralateral side. The parameters obtained in this study were maximal displacement (Dm), and contraction time (Tc). The Tc of the injured GM was significantly higher compared to the healthy side (p = 0.01). There were no significant side-to-side differences in the Dm of the GM (p = 0.13), either in the Tc and Dm of the RF (p = 0.15 and p = 0.8, respectively) and AM (p = 0.25 and p = 0.75, respectively). FAI is associated with impairment of contraction time in the GM of the injured compared to the healthy side. Impairment of the GM may be monitored to evaluate response to conservative or surgical treatment.

Evaluation of tolerability and efficacy of incorporating carboplatin in neoadjuvant anthracycline and taxane based therapy in a BRCA1 enriched triple-negative breast cancer cohort.

PubMed

Sella, Tal; Gal Yam, Einav Nili; Levanon, Keren; Rotenberg, Tal Shapira; Gadot, Moran; Kuchuk, Iryna; Molho, Rinat Bernstein; Itai, Amit; Modiano, Tami Mekel; Gold, Raya; Kaufman, Bella; Shimon, Shani Paluch

2018-05-22

The addition of carboplatin (Cb) to neoadjuvant chemotherapy in triple-negative breast cancer (TNBC) has been demonstrated to improve pathologic complete response (pCR) at the expense of increased toxicity. We aimed to evaluate the effectiveness and tolerability of dose-dense anthracycline & cyclophosphamide (ddAC) followed by weekly paclitaxel (wT) in combination with weekly Cb. Retrospective data was collected on patients with clinical stage I-III TNBC treated with neoadjuvant ddAC-wTCb (four cycles of ddA 60 mg/m 2 and ddC 600 mg/m 2 every 2 weeks followed by 12 cycles of wT 80 mg/m 2 with Cb AUC 1.5). Indices of tolerability and pCR were evaluated and compared to a historical cohort (n = 76) treated with ddAC-T. A secondary objective was to evaluate the rates of pCR by BRCA status. For 43 eligible patients, mean age was 41.5 years, 51% had clinical stage II disease, 81.4% were clinically node positive and 32.6% carried a deleterious BRCA1 mutation. Only 35% completed all scheduled doses of chemotherapy. Grade 3/4 neutropenia was observed in 42.5% of patients. Overall pCR was 51.2%; 44.8% in BRCA wild-type compared to 64.3% in BRCA-associated TNBC (p = 0.232). pCR rates with ddAC-wTCb were similar to historic institutional rates with ddAC-T (51.2% vs. 51.3%, p = 0.987) and were comparable when stratified by BRCA status. In pooled multivariate analysis, only BRCA status (HR 4.00, 95%CI 1.65-9.75, p = 0.002) was significantly associated with pCR. Neoadjuvant ddAC-wTCb is less tolerable in clinical practice compared to most clinical trials, with a pCR comparable to historic rates using non-platinum regimen. The role of Cb in neoadjuvant chemotherapy for BRCA mutated TNBC remains uncertain. Copyright © 2018 Elsevier Ltd. All rights reserved.

Comparing student clinical self-efficacy and team process outcomes for a DEU, blended, and traditional clinical setting: A quasi-experimental research study.

PubMed

Plemmons, Christina; Clark, Michele; Feng, Du

2018-03-01

Clinical education is vital to both the development of clinical self-efficacy and the integration of future nurses into health care teams. The dedicated education unit clinical teaching model is an innovative clinical partnership, which promotes skill development, professional growth, clinical self-efficacy, and integration as a team member. Blended clinical teaching models are combining features of the dedicated education unit and traditional clinical model. The aims of this study are to explore how each of three clinical teaching models (dedicated education unit, blended, traditional) affects clinical self-efficacy and attitude toward team process, and to compare the dedicated education unit model and blended model to traditional clinical. A nonequivalent control-group quasi-experimental design was utilized. The convenience sample of 272 entry-level baccalaureate nursing students included 84 students participating in a dedicated education unit model treatment group, 66 students participating in a blended model treatment group, and 122 students participating in a traditional model control group. Perceived clinical self-efficacy was evaluated by the pretest/posttest scores obtained on the General Self-Efficacy scale. Attitude toward team process was evaluated by the pretest/posttest scores obtained on the TeamSTEPPS® Teamwork Attitude Questionnaire. All three clinical teaching models resulted in significant increases in both clinical self-efficacy (p=0.04) and attitude toward team process (p=0.003). Students participating in the dedicated education unit model (p=0.016) and students participating in the blended model (p<0.001) had significantly larger increases in clinical self-efficacy compared to students participating in the traditional model. These findings support the use of dedicated education unit and blended clinical partnerships as effective alternatives to the traditional model to promote both clinical self-efficacy and team process among entry-level baccalaureate nursing students. Copyright © 2017 Elsevier Ltd. All rights reserved.

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method

NASA Astrophysics Data System (ADS)

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A.; Purdie, Thomas G.

2017-08-01

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

Fully automated treatment planning for head and neck radiotherapy using a voxel-based dose prediction and dose mimicking method.

PubMed

McIntosh, Chris; Welch, Mattea; McNiven, Andrea; Jaffray, David A; Purdie, Thomas G

2017-07-06

Recent works in automated radiotherapy treatment planning have used machine learning based on historical treatment plans to infer the spatial dose distribution for a novel patient directly from the planning image. We present a probabilistic, atlas-based approach which predicts the dose for novel patients using a set of automatically selected most similar patients (atlases). The output is a spatial dose objective, which specifies the desired dose-per-voxel, and therefore replaces the need to specify and tune dose-volume objectives. Voxel-based dose mimicking optimization then converts the predicted dose distribution to a complete treatment plan with dose calculation using a collapsed cone convolution dose engine. In this study, we investigated automated planning for right-sided oropharaynx head and neck patients treated with IMRT and VMAT. We compare four versions of our dose prediction pipeline using a database of 54 training and 12 independent testing patients by evaluating 14 clinical dose evaluation criteria. Our preliminary results are promising and demonstrate that automated methods can generate comparable dose distributions to clinical. Overall, automated plans achieved an average of 0.6% higher dose for target coverage evaluation criteria, and 2.4% lower dose at the organs at risk criteria levels evaluated compared with clinical. There was no statistically significant difference detected in high-dose conformity between automated and clinical plans as measured by the conformation number. Automated plans achieved nine more unique criteria than clinical across the 12 patients tested and automated plans scored a significantly higher dose at the evaluation limit for two high-risk target coverage criteria and a significantly lower dose in one critical organ maximum dose. The novel dose prediction method with dose mimicking can generate complete treatment plans in 12-13 min without user interaction. It is a promising approach for fully automated treatment planning and can be readily applied to different treatment sites and modalities.

[Immunological surrogate endpoints to evaluate vaccine efficacy].

PubMed

Jin, Pengfei; Li, Jingxin; Zhou, Yang; Zhu, Fengcai

2015-12-01

An immunological surrogate endpoints is a vaccine-induced immune response (either humoral or cellular immune) that predicts protection against clinical endpoints (infection or disease), and can be used to evaluate vaccine efficacy in clinical vaccine trials. Compared with field efficacy trials observing clinical endpoints, immunological vaccine trials could reduce the sample size or shorten the duration of a trial, which promote the license and development of new candidate vaccines. For these reasons, establishing immunological surrogate endpoints is one of 14 Grand Challenges of Global Health of the National Institutes of Health (NIH) and the Bill and Melinda Gates Foundation. From two parts of definition and statistical methods for evaluation of surrogate endpoints, this review provides a more comprehensive description.

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.

A Systems Approach to Designing Effective Clinical Trials Using Simulations

PubMed Central

Fusaro, Vincent A.; Patil, Prasad; Chi, Chih-Lin; Contant, Charles F.; Tonellato, Peter J.

2013-01-01

Background Pharmacogenetics in warfarin clinical trials have failed to show a significant benefit compared to standard clinical therapy. This study demonstrates a computational framework to systematically evaluate pre-clinical trial design of target population, pharmacogenetic algorithms, and dosing protocols to optimize primary outcomes. Methods and Results We programmatically created an end-to-end framework that systematically evaluates warfarin clinical trial designs. The framework includes options to create a patient population, multiple dosing strategies including genetic-based and non-genetic clinical-based, multiple dose adjustment protocols, pharmacokinetic/pharmacodynamics (PK/PD) modeling and international normalization ratio (INR) prediction, as well as various types of outcome measures. We validated the framework by conducting 1,000 simulations of the CoumaGen clinical trial primary endpoints. The simulation predicted a mean time in therapeutic range (TTR) of 70.6% and 72.2% (P = 0.47) in the standard and pharmacogenetic arms, respectively. Then, we evaluated another dosing protocol under the same original conditions and found a significant difference in TTR between the pharmacogenetic and standard arm (78.8% vs. 73.8%; P = 0.0065), respectively. Conclusions We demonstrate that this simulation framework is useful in the pre-clinical assessment phase to study and evaluate design options and provide evidence to optimize the clinical trial for patient efficacy and reduced risk. PMID:23261867

Evaluation of Four Pulpotomy Techniques in Primary Molars: A Randomized Controlled Trial

PubMed Central

Ansari, Ghassem; Morovati, Seyyedeh Pouya; Asgary, Saeed

2018-01-01

Introduction: This trial was designed to evaluate the clinical and radiographic success rates of calcium-enriched mixture (CEM) cement with and without low level laser therapy (LLLT) and compare them to that of formocresol (FC) and ferric sulfate (FS) in primary molar pulpotomies. Methods and Materials: This randomized clinical trial was conducted on a total of 160 teeth selected from 40 patients aged 3-9 years. Patients with at least four primary molars needing pulpotomy, were included in order to have each tooth assigned randomly in one of the four following groups; FC, FS, CEM, and LLLT/CEM. Six- and twelve-month follow-up periods were conducted in order to enable a clinical and radiographic evaluation of the treated teeth. Collected data were analyzed using Cochran Q Tests. Results: The 12-month clinical success rate for each technique was: FC=100%, FS=95%, CEM=97.5% and LLLT/CEM=100% with no significant differences (P>0.05). Furthermore, 12-month radiographic success rate for each technique was: FC=100%, FS=92.5%, CEM=95% and LLLT/CEM=100% with no significant differences (P>0.05). Conclusion: Favorable outcomes of four treatment techniques in pulpotomy of primary molar teeth were comparable. CEM with/without LLLT may be considered as a safe and successful pulpotomy treatment modality compared to current conventional methods. PMID:29692828

Standardized evaluation of algorithms for computer-aided diagnosis of dementia based on structural MRI: the CADDementia challenge.

PubMed

Bron, Esther E; Smits, Marion; van der Flier, Wiesje M; Vrenken, Hugo; Barkhof, Frederik; Scheltens, Philip; Papma, Janne M; Steketee, Rebecca M E; Méndez Orellana, Carolina; Meijboom, Rozanna; Pinto, Madalena; Meireles, Joana R; Garrett, Carolina; Bastos-Leite, António J; Abdulkadir, Ahmed; Ronneberger, Olaf; Amoroso, Nicola; Bellotti, Roberto; Cárdenas-Peña, David; Álvarez-Meza, Andrés M; Dolph, Chester V; Iftekharuddin, Khan M; Eskildsen, Simon F; Coupé, Pierrick; Fonov, Vladimir S; Franke, Katja; Gaser, Christian; Ledig, Christian; Guerrero, Ricardo; Tong, Tong; Gray, Katherine R; Moradi, Elaheh; Tohka, Jussi; Routier, Alexandre; Durrleman, Stanley; Sarica, Alessia; Di Fatta, Giuseppe; Sensi, Francesco; Chincarini, Andrea; Smith, Garry M; Stoyanov, Zhivko V; Sørensen, Lauge; Nielsen, Mads; Tangaro, Sabina; Inglese, Paolo; Wachinger, Christian; Reuter, Martin; van Swieten, John C; Niessen, Wiro J; Klein, Stefan

2015-05-01

Algorithms for computer-aided diagnosis of dementia based on structural MRI have demonstrated high performance in the literature, but are difficult to compare as different data sets and methodology were used for evaluation. In addition, it is unclear how the algorithms would perform on previously unseen data, and thus, how they would perform in clinical practice when there is no real opportunity to adapt the algorithm to the data at hand. To address these comparability, generalizability and clinical applicability issues, we organized a grand challenge that aimed to objectively compare algorithms based on a clinically representative multi-center data set. Using clinical practice as the starting point, the goal was to reproduce the clinical diagnosis. Therefore, we evaluated algorithms for multi-class classification of three diagnostic groups: patients with probable Alzheimer's disease, patients with mild cognitive impairment and healthy controls. The diagnosis based on clinical criteria was used as reference standard, as it was the best available reference despite its known limitations. For evaluation, a previously unseen test set was used consisting of 354 T1-weighted MRI scans with the diagnoses blinded. Fifteen research teams participated with a total of 29 algorithms. The algorithms were trained on a small training set (n=30) and optionally on data from other sources (e.g., the Alzheimer's Disease Neuroimaging Initiative, the Australian Imaging Biomarkers and Lifestyle flagship study of aging). The best performing algorithm yielded an accuracy of 63.0% and an area under the receiver-operating-characteristic curve (AUC) of 78.8%. In general, the best performances were achieved using feature extraction based on voxel-based morphometry or a combination of features that included volume, cortical thickness, shape and intensity. The challenge is open for new submissions via the web-based framework: http://caddementia.grand-challenge.org. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of the COBAS Hepatitis C Virus (HCV) TaqMan analyte-specific reagent assay and comparison to the COBAS Amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 assays.

PubMed

Konnick, Eric Q; Williams, Sheri M; Ashwood, Edward R; Hillyard, David R

2005-05-01

Performance characteristics of the COBAS hepatitis C virus (HCV) TaqMan analyte-specific reagent (TM-ASR) assay using the QIAGEN BioRobot 9604 for RNA extraction were evaluated and compared to the COBAS Amplicor HCV Monitor V2.0 (Amplicor) and Versant HCV bDNA 3.0 (Versant) assays using clinical samples. Calibration of TM-ASR using Armored RNA allowed determination of the distribution of HCV RNA in clinical samples, using 22,399 clinical samples. Limit of detection, linearity, and inter- and intraassay assay precision were determined for the TM-ASR assay using multiple clinical specimen panels across multiple determinations. Genotype specificity for the TM-ASR assay was determined using samples with different HCV RNA genotypes evaluated and compared against predetermined results. Contamination control of the TM-ASR assay was evaluated using pools of HCV RNA-positive and -negative samples tested in a checkerboard pattern over 12 runs of 96 samples. Correlation of the TM-ASR, Amplicor, and Versant assays was determined using 100 paired clinical samples and Deming regression analysis. The TM-ASR performed well with respect to linearity, precision, and contamination control. The correlation between TM-ASR and the Amplicor and Versant assays was poor, with large differences between assay results for individual samples. Calibration of the TM-ASR assay with Armored RNA allowed for a wide dynamic range and description of the distribution of HCV RNA in clinical samples.

Evaluation of the COBAS Hepatitis C Virus (HCV) TaqMan Analyte-Specific Reagent Assay and Comparison to the COBAS Amplicor HCV Monitor V2.0 and Versant HCV bDNA 3.0 Assays

PubMed Central

Konnick, Eric Q.; Williams, Sheri M.; Ashwood, Edward R.; Hillyard, David R.

2005-01-01

Performance characteristics of the COBAS hepatitis C virus (HCV) TaqMan analyte-specific reagent (TM-ASR) assay using the QIAGEN BioRobot 9604 for RNA extraction were evaluated and compared to the COBAS Amplicor HCV Monitor V2.0 (Amplicor) and Versant HCV bDNA 3.0 (Versant) assays using clinical samples. Calibration of TM-ASR using Armored RNA allowed determination of the distribution of HCV RNA in clinical samples, using 22,399 clinical samples. Limit of detection, linearity, and inter- and intraassay assay precision were determined for the TM-ASR assay using multiple clinical specimen panels across multiple determinations. Genotype specificity for the TM-ASR assay was determined using samples with different HCV RNA genotypes evaluated and compared against predetermined results. Contamination control of the TM-ASR assay was evaluated using pools of HCV RNA-positive and -negative samples tested in a checkerboard pattern over 12 runs of 96 samples. Correlation of the TM-ASR, Amplicor, and Versant assays was determined using 100 paired clinical samples and Deming regression analysis. The TM-ASR performed well with respect to linearity, precision, and contamination control. The correlation between TM-ASR and the Amplicor and Versant assays was poor, with large differences between assay results for individual samples. Calibration of the TM-ASR assay with Armored RNA allowed for a wide dynamic range and description of the distribution of HCV RNA in clinical samples. PMID:15872232

When should we use nitrates in congestive heart failure?

PubMed

Vizzardi, Enrico; Bonadei, Ivano; Rovetta, Riccardo; D'Aloia, Antonio; Quinzani, Filippo; Curnis, Antonio; Dei Cas, Livio

2013-02-01

Organic nitrates remain among the oldest and most commonly employed drugs in cardiology. Although, in most cases, their use in acute and chronic heart failure is based on clinical practice, only a few clinical trials have been conducted to evaluate their use in acute and chronic heart failure, most of which compare them with other drugs to evaluate differing endpoints. The purpose of this review is to examine the various trials that have evaluated the use of nitrates in acute and chronic heart failure. © 2012 Blackwell Publishing Ltd.

Is the large simple trial design used for comparative, post-approval safety research? A review of a clinical trials registry and the published literature.

PubMed

Reynolds, Robert F; Lem, Joanna A; Gatto, Nicolle M; Eng, Sybil M

2011-10-01

Post-approval, observational drug safety studies face well known difficulties in controlling for confounding, particularly confounding by indication for drug use. A study design that addresses confounding by indication is the large simple trial (LST). LSTs are characterized by large sample sizes, often in the thousands; broad entry criteria consistent with the approved medication label; randomization based on equipoise, i.e. neither physician nor patient believes that one treatment option is superior; minimal, streamlined data collection requirements; objectively-measured endpoints (e.g. death, hospitalization); and follow-up that minimizes interventions or interference with normal clinical practice. In theory then, the LST is a preferred study design for drug and vaccine safety research because it controls for biases inherent to observational research while still providing results that are generalizable to 'real-world' use. To evaluate whether LSTs are used for comparative safety evaluation and if the design is, in fact, advantageous compared with other designs, we conducted a review of the published literature (1949 through 31 December 2010) and the ClinicalTrials.gov registry (2000 through 31 December 2010). Thirteen ongoing or completed safety LSTs were identified. The design has rarely been used in comparative drug safety research, which is due to the operational, financial and scientific hurdles of implementing the design. The studies that have been completed addressed important clinical questions and, in some cases, led to re-evaluation of medical practice. We conclude the design has demonstrated utility for comparative safety research of medicines and vaccines if the necessary scientific and operational conditions for its use are met.

A randomized comparative study of levofloxacin versus amoxicillin/clavulanate for treatment of infants and young children with recurrent or persistent acute otitis media.

PubMed

Noel, Gary J; Blumer, Jeffrey L; Pichichero, Michael E; Hedrick, James A; Schwartz, Richard H; Balis, Dainius A; Melkote, Rama; Bagchi, Partha; Arguedas, Adriano

2008-06-01

The need for alternative antimicrobial therapy for recurrent and persistent acute otitis media (AOM) in children has raised interest in assessing the efficacy and safety of fluoroquinolones for treatment of these infections. In an evaluator-blinded, active-comparator, noninferiority, multicenter study, children (6 months to <5 years) were randomized 1:1 to receive levofloxacin (10 mg/kg twice daily) or amoxicillin/clavulanate (14:1; amoxicillin 45 mg/kg twice daily) for 10 days, with evaluations 4-6 days of therapy (visit 2), 2-5 days after completing therapy (visit 3), and 10-17 days after last dose (visit 4). Primary outcome was clinical cure at visit 3 based on resolution of clinical signs and symptoms of AOM. A total of 1650 children were randomized and 1305 were clinically evaluable at visit 3 (630 levofloxacin, 675 comparator). Clinical cure rates were 72.4% (456 of 630) in levofloxacin-treated and 69.9% (472 of 675) in amoxicillin/clavulanate-treated children. Cure rates were also similar for levofloxacin and comparator for each age group (< or =24 months: 68.9% versus 66.2%; >24 months: 76.9% versus 75.1%; respectively). Cure rates at visit 4 were 74.9% and 73.8% in levofloxacin and amoxicillin/clavulanate groups, respectively. The upper limits of the confidence intervals were less than the noninferiority margin of 10% indicating that levofloxacin treatment is noninferior to comparator treatment overall and in both infants (6 months to 2 years) and children 2-5 years. No differences between treatment groups regarding the frequency or type of adverse events were apparent. Levofloxacin was not inferior to amoxicillin/clavulanate for the treatment of recurrent and/or persistent AOM in infants and children.

Comparative Cost-effectiveness of Strategies to Prevent Postoperative Clinical Recurrence of Crohn's Disease

PubMed Central

Doherty, Glen A.; Miksad, Rebecca A.; Cheifetz, Adam S.; Moss, Alan C.

2012-01-01

Background A number of treatments have been shown to reduce the risk of postoperative recurrence of Crohn's disease (CD). The optimal strategy is unknown. The aim was to evaluate the comparative cost-effectiveness of postoperative strategies to prevent clinical recurrence of CD. Methods Three prophylactic strategies were compared to “no prophylaxis”; mesalamine, azathioprine (AZA) / 6-mercaptopurine (6-MP), and infliximab. The probability of clinical recurrence, endoscopic recurrence, and therapy discontinuation due to adverse drug reactions (ADRs) were extracted from randomized controlled trials (RCTs). Quality-of-life scores and treatment costs were derived from published data. The primary model evaluated quality-adjusted life years (QALYs) and cost-effectiveness at 1 year after surgery. Sensitivity analysis assessed the impact of a range of recurrence rates on cost-effectiveness. An exploratory analysis evaluated cost-effectiveness outcomes 5 years after surgery. Results A strategy of “no prophylaxis” was the least expensive one at 1 and 5 years after surgery. Compared to this approach, AZA/6-MP had the most favorable incremental cost-effectiveness ratio (ICER) ($299,188/QALY gained), and yielded the highest net health benefits of the medication strategies at 1 year. Sensitivity analysis determined that the ICER of AZA/6-MP was preferable to mesalamine up to a recurrence rate of 52%, but mesalamine dominated at higher rates. In the 5-year exploratory analysis, mesalamine had the most favorable ICER over 5 years ($244,177/QALY gained). Conclusions Compared to no prophylactic treatment, AZA/6-MP has the most favorable ICER in the prevention of clinical recurrence of postoperative CD up to 1 year. At 5 years, mesalamine had the most favorable ICER in this model. PMID:21905173

A semi-automated tool for treatment plan-quality evaluation and clinical trial quality assurance

NASA Astrophysics Data System (ADS)

Wang, Jiazhou; Chen, Wenzhou; Studenski, Matthew; Cui, Yunfeng; Lee, Andrew J.; Xiao, Ying

2013-07-01

The goal of this work is to develop a plan-quality evaluation program for clinical routine and multi-institutional clinical trials so that the overall evaluation efficiency is improved. In multi-institutional clinical trials evaluating the plan quality is a time-consuming and labor-intensive process. In this note, we present a semi-automated plan-quality evaluation program which combines MIMVista, Java/MATLAB, and extensible markup language (XML). More specifically, MIMVista is used for data visualization; Java and its powerful function library are implemented for calculating dosimetry parameters; and to improve the clarity of the index definitions, XML is applied. The accuracy and the efficiency of the program were evaluated by comparing the results of the program with the manually recorded results in two RTOG trials. A slight difference of about 0.2% in volume or 0.6 Gy in dose between the semi-automated program and manual recording was observed. According to the criteria of indices, there are minimal differences between the two methods. The evaluation time is reduced from 10-20 min to 2 min by applying the semi-automated plan-quality evaluation program.

Health economic evaluation of patients treated for nosocomial pneumonia caused by methicillin-resistant Staphylococcus aureus: secondary analysis of a multicenter randomized clinical trial of vancomycin and linezolid.

PubMed

Niederman, Michael S; Chastre, Jean; Solem, Caitlyn T; Wan, Yin; Gao, Xin; Myers, Daniela E; Haider, Seema; Li, Jim Z; Stephens, Jennifer M

2014-09-01

Results from studies comparing health care resource use (HCRU), costs of treatment, and cost-effectiveness of linezolid compared with vancomycin therapy in the treatment of hospitalized patients with methicillin-resistant Staphylococcus aureus (MRSA) nosocomial pneumonia are limited in the published literature. We therefore conducted an analysis to compare the HCRU, costs of treatment, and cost-effectiveness of linezolid compared with vancomycin in the treatment of hospitalized patients with MRSA nosocomial pneumonia using data from a Phase IV clinical trial. The economic effect of moderate to severe adverse events (MSAEs) and the development of renal failure were also evaluated. We performed a post hoc analysis of data from a Phase IV, double-blind, randomized, comparator-controlled, multicenter trial that compared linezolid and vancomycin treatment in patients with MRSA nosocomial pneumonia. HCRU and costs were compared based on treatment, development of MSAEs, and development of renal failure using data from the modified intent-to-treat population. Predictors of costs were evaluated using generalized linear models. A piggyback cost-effectiveness analysis was conducted to assess the incremental cost-effectiveness ratio of linezolid versus vancomycin, given the significantly higher clinical success of linezolid compared with vancomycin found in the trial. Overall, HCRU and costs were similar between the linezolid and vancomycin treatment groups; drug costs were significantly higher and dialysis costs significantly lower for linezolid- compared with vancomycin-treated patients. Total treatment costs were approximately $8000 higher (P = .046) for patients who developed renal failure compared with those who did not. Renal failure occurred more commonly in patients randomized to receive vancomycin (15%) compared with linezolid (4%; P < .001). Region, ventilator-associated pneumonia, clinical failure, and development of renal failure were associated with significantly higher total costs. The point estimate incremental cost-effectiveness ratio for linezolid compared with vancomycin was $16,516 per treatment success, with linezolid dominant in 24% and dominated in <2% of bootstrapped samples. This phase 4 clinical trial conducted in patients with MRSA-confirmed nosocomial pneumonia reveals that linezolid- compared with vancomycin-treated patients had similar HCRU and total overall costs. Fewer patients developed renal failure during the study while taking linezolid compared with vancomycin, and patients with a documented MSAE or renal failure had increased HCRU and costs. In summary, linezolid may be a cost-effective treatment strategy in MRSA-confirmed nosocomial pneumonia. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

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.

Evaluation and comparison of clinical results of femoral fixation devices in arthroscopic anterior cruciate ligament reconstruction.

PubMed

Aydin, Deniz; Ozcan, Mert

2016-03-01

Several femoral fixation devices are available for hamstring tendon autograft in anterior cruciate ligament (ACL) reconstruction, but the best technique is debatable. We hypothesised that different suspensory femoral fixation techniques have no superiority over each other. The aim of this study was to evaluate and compare the clinical results of different suspensory femoral fixation devices in arthroscopic ACL reconstruction. This was a Level III, retrospective, comparative study. A total of 100 consecutive patients who underwent arthroscopic ACL reconstruction in a single institution with a mean follow-up time of 40 months (12-67 months) were divided into three groups according to femoral fixation devices as 'Endobutton' (n=34), 'Transfix' (n=35) and 'Aperfix' (n=31). The length of painful period after surgery, time to return to work and sporting activities, final range of motion, anterior drawer and Lachman tests, knee instability symptoms, International Knee Documentation Committee (IKDC) subjective knee evaluation score, Short Form 36 (SF-36) score, Lysholm knee score and Tegner point of the patients were evaluated and compared between groups. There were no significant differences between the groups. All techniques led to significant recovery in knee instability tests and symptoms. In this study, the clinical results of different suspensory femoral fixation techniques were found to be similar. We believe that different femoral fixation techniques have no effect on clinical results provided that the technique is correctly applied. The surgeon must choose a technique appropriate to his or her experience. Copyright © 2015 Elsevier B.V. All rights reserved.

[Clinical evaluation of heavy-particle radiotherapy using dose volume histogram (DVH)].

PubMed

Terahara, A; Nakano, T; Tsujii, H

1998-01-01

Radiotherapy with heavy particles such as proton and heavy-charged particles is a promising modality for treatment of localized malignant tumors because of the good dose distribution. A dose calculation and radiotherapy planning system which is essential for this kind of treatment has been developed in recent years. It has the capability to compute the dose volume histogram (DVH) which contains dose-volume information for the target volume and other interesting volumes. Recently, DVH is commonly used to evaluate and compare dose distributions in radiotherapy with both photon and heavy particles, and it shows that a superior dose distribution is obtained in heavy particle radiotherapy. DVH is also utilized for the evaluation of dose distribution related to clinical outcomes. Besides models such as normal tissue complication probability (NTCP) and tumor control probability (TCP), which can be calculated from DVH are proposed by several authors, they are applied to evaluate dose distributions themselves and to evaluate them in relation to clinical results. DVH is now a useful and important tool, but further studies are needed to use DVH and these models practically for clinical evaluation of heavy-particle radiotherapy.

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

PubMed

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

2017-07-27

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

Comparative evaluation of neonatal bilirubin using Radiometer whole blood co-oximetry and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics.

PubMed

Lano, Ian Marie; Lyon, Andrew W; Wang, Li; Ruskin, Rob; Lyon, Martha E

2018-03-01

Clinically significant variation has been reported within and between plasma and whole blood total bilirubin methods used to identify neonates for whom clinical intervention for hyperbilirubinemia may be required. To evaluate total bilirubin measurements between the Radiometer whole blood co-oximeter and plasma bilirubin methods from Roche Diagnostics and Ortho Clinical Diagnostics using neonatal specimens. Total bilirubin levels were analyzed by whole blood co-oximetry (Radiometer® ABL90). Specimens were centrifuged and plasma analyzed for total bilirubin with a diazo method (Roche Cobas® C-601) and a reflectance spectrophotometric BuBc dry film method (Ortho Clinical Diagnostics VITROS® 350). Results were evaluated by regression, Bland-Altman comparisons and t-tests. The patient correlation study yielded the following regression equations in μmol/L: a) Radiometer=1.03 Roche - 3.5μmol/L b) Radiometer=0.98 Ortho - 5.7μmol/L c) Roche=0.97 Ortho - 2.4μmol/L. The mean bias over the range of total bilirubin levels examined was -1.0μmol/L for the Radiometer versus the Roche (p≤0.305); -4.4μmol/L for the Radiometer versus Ortho (p≤0.005) and -4.4μmol/L for the Roche versus Ortho (p≤0.002). Whole blood total bilirubin measurement using the Radiometer ABL90 blood gas analyzer provides accurate and precise results compared to the Roche plasma diazo method. Compared to the reflectance spectrophotometric method, results are precise and had a small but statistically significant bias of -4.4μmol/L. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Use of error grid analysis to evaluate acceptability of a point of care prothrombin time meter.

PubMed

Petersen, John R; Vonmarensdorf, Hans M; Weiss, Heidi L; Elghetany, M Tarek

2010-02-01

Statistical methods (linear regression, correlation analysis, etc.) are frequently employed in comparing methods in the central laboratory (CL). Assessing acceptability of point of care testing (POCT) equipment, however, is more difficult because statistically significant biases may not have an impact on clinical care. We showed how error grid (EG) analysis can be used to evaluate POCT PT INR with the CL. We compared results from 103 patients seen in an anti-coagulation clinic that were on Coumadin maintenance therapy using fingerstick samples for POCT (Roche CoaguChek XS and S) and citrated venous blood samples for CL (Stago STAR). To compare clinical acceptability of results we developed an EG with zones A, B, C and D. Using 2nd order polynomial equation analysis, POCT results highly correlate with the CL for CoaguChek XS (R(2)=0. 955) and CoaguChek S (R(2)=0. 93), respectively but does not indicate if POCT results are clinically interchangeable with the CL. Using EG it is readily apparent which levels can be considered clinically identical to the CL despite analytical bias. We have demonstrated the usefulness of EG in determining acceptability of POCT PT INR testing and how it can be used to determine cut-offs where differences in POCT results may impact clinical care. Copyright 2009 Elsevier B.V. All rights reserved.

Cost effectiveness of high-sensitivity troponin compared to conventional troponin among patients presenting with undifferentiated chest pain: A trial based analysis.

PubMed

Kaambwa, Billingsley; Ratcliffe, Julie; Horsfall, Matthew; Astley, Carolyn; Karnon, Jonathan; Coates, Penelope; Arstall, Margaret; Zeitz, Christopher; Worthley, Matthew; Beltrame, John; Chew, Derek P

2017-07-01

Patients with low and intermediate risk chest pain features comprise the greatest proportion presenting to emergency services for evaluation of suspected acute coronary syndromes (ACS). The efficient and timely identification of patients with these features remains a major challenge within clinical practice. Troponin assays are increasingly being used for the determination of risk among patients presenting with chest pain potentially facilitating more appropriate care. To date, no economic evaluation comparing high-sensitivity troponin T (hs-TnT) reporting to standard troponin T (c-TnT) reporting in the routine management of suspected ACS and based on longer-term clinical outcomes has been conducted. An economic evaluation was conducted with 1937 participants randomized to either hs-TnT (n=973) or c-TnT (n=964) with 12month follow-up. The primary outcome measure was the number of cumulative combined outcomes of all-cause mortality and new or recurrent ACS avoided. Mean per participant Australian Medicare costs were higher in the hs-TnT arm compared to the c-TnT arm (by $1285/patient). Mean total adverse clinical outcomes avoided were higher in the hs-TnT arm (by 0.0120/patient) resulting in an incremental cost-effectiveness ratio (ICER) of $108,552/adverse clinical outcome avoided. An ICER of $49,030/adverse clinical outcome avoided was obtained when the analysis was restricted to patients below the threshold of normal Troponin testing (actual c-TnT levels <30ng/L). hs-TnT reporting leads to fewer adverse clinical events but at a high ICER. For the routine implementation of hs-TnT to be more cost-effective, substantial changes in clinical practice will be required. Australian New Zealand Clinical Trials Registry (ACTRN12614000189628). https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365726. Copyright © 2017 Elsevier B.V. All rights reserved.

Lung Ultrasonography: A Viable Alternative to Chest Radiography in Children with Suspected Pneumonia?

PubMed

Ambroggio, Lilliam; Sucharew, Heidi; Rattan, Mantosh S; O'Hara, Sara M; Babcock, Diane S; Clohessy, Caitlin; Steinhoff, Mark C; Macaluso, Maurizio; Shah, Samir S; Coley, Brian D

2016-09-01

To determine the interrater reliability (IRR) of lung ultrasonography (LUS) and chest radiography (CXR) and evaluate the accuracy of LUS compared with CXR for detecting pediatric pneumonia compared with chest computed tomography (CT) scan. This was a prospective cohort study of children aged 3 months to 18 years with a CXR and LUS performed between May 1, 2012, and January 31, 2014 with or without a clinical diagnosis of pneumonia. Four pediatric radiologists blinded to clinical information reported findings for the CXR and LUS images. IRR was estimated for 50 LUS and CXR images. The main outcome was the finding from CT ordered clinically or the probability of the CT finding for patients clinically requiring CT. Two radiologists reviewed CT scans to determine an overall finding. Latent class analysis was used to evaluate the sensitivity and specificity for findings (eg, consolidation) for LUS and CXR compared with CT. Of the 132 patients in the cohort, 36 (27%) had CT performed for a clinical reason. Pneumonia was clinically documented in 47 patients (36%). The IRR for lung consolidation was 0.55 (95% CI, 0.40-0.70) for LUS and 0.36 (95% CI, 0.21-0.51) for CXR. The sensitivity for detecting consolidation, interstitial disease, and pleural effusion was statistically similar for LUS and CXR compared with CT; however, specificity was higher for CXR. The negative predictive value was similar for CXR and LUS. LUS has a sufficiently high IRR for detection of consolidation. Compared with CT, LUS and CXR have similar sensitivity, but CXR is more specific for findings indicating pneumonia. Copyright © 2016 Elsevier Inc. All rights reserved.

Resident Cosmetic Clinic: Practice Patterns, Safety, and Outcomes at an Academic Plastic Surgery Institution.

PubMed

Qureshi, Ali A; Parikh, Rajiv P; Myckatyn, Terence M; Tenenbaum, Marissa M

2016-10-01

Comprehensive aesthetic surgery education is an integral part of plastic surgery residency training. Recently, the ACGME increased minimum requirements for aesthetic procedures in residency. To expand aesthetic education and prepare residents for independent practice, our institution has supported a resident cosmetic clinic for over 25 years. To evaluate the safety of procedures performed through a resident clinic by comparing outcomes to benchmarked national aesthetic surgery outcomes and to provide a model for resident clinics in academic plastic surgery institutions. We identified a consecutive cohort of patients who underwent procedures through our resident cosmetic clinic between 2010 and 2015. Major complications, as defined by CosmetAssure database, were recorded and compared to published aesthetic surgery complication rates from the CosmetAssure database for outcomes benchmarking. Fisher's exact test was used to compare sample proportions. Two hundred and seventy-one new patients were evaluated and 112 patients (41.3%) booked surgery for 175 different aesthetic procedures. There were 55 breast, 19 head and neck, and 101 trunk or extremity aesthetic procedures performed. The median number of preoperative and postoperative visits was 2 and 4 respectively with a mean follow-up time of 35 weeks. There were 3 major complications (2 hematomas and 1 infection requiring IV antibiotics) with an overall complication rate of 1.7% compared to 2.0% for patients in the CosmetAssure database (P = .45). Surgical outcomes for procedures performed through a resident cosmetic clinic are comparable to national outcomes for aesthetic surgery procedures, suggesting this experience can enhance comprehensive aesthetic surgery education without compromising patient safety or quality of care. 4 Risk. © 2016 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

[Evaluation of cartilage defects in the knee: validity of clinical, magnetic-resonance-imaging and radiological findings compared with arthroscopy].

PubMed

Spahn, G; Wittig, R; Kahl, E; Klinger, H M; Mückley, T; Hofmann, G O

2007-05-01

The study was aimed to evaluate the validity of clinical, radiological and MRI examination for cartilage defects of the knee compared with arthroscopic finding. Seven-hundred seventy-two patients who were suffering from knee pain over more than 3 months were evaluated clinical (grinding-sign) and with radiography and magnetic resonance imaging (MRI) and subsequent arthroscopy. The grinding sign had a sensitivity of 0.39. The association of a positive grinding test with high grade cartilage defects was significant (p<0.000). In 97.4% an intact chondral surface correlated with a normal radiological finding. Subchondral sclerosis, exophytes and a joint space narrowing was significantly associated with high grade cartilage defects (p<0.000). The accuracy of MRI was 59.5%. The MRI resulted in an overestimation in 36.6% and an underestimation in 3.9%. False-positive results were significant more often assessed in low-grade cartilage defects (p<0.000). Clinical signs, x-ray imaging and MRI correlate with arthroscopic findings in cases of deep cartilage lesions. In intact or low-grade degenerated cartilage often results an overestimating of these findings.

ClinicAl Evaluation of Dental Restorative Materials

DTIC Science & Technology

1989-01-01

use of an Atuarial Life Table Survival Analysis procedure. The median survival time for anterior composites was 13.5 years, as compared to 12.1 years...dental materials. For the first time in clinical biomaterials research, we used a statistical approach of Survival Analysis which utilized the... analysis has been established to assure uniformity in usage. This scale is now in use by clinical investigators throughout the country. Its use at the

EVALUATION OF CLINICAL PERIODONTAL CONDITIONS IN SMOKERS AND NON-SMOKERS

PubMed Central

Luzzi, Lucinara Ignez Tavares; Greghi, Sebastião Luiz Aguiar; Passanezi, Euloir; Sant'ana, Adriana Campos Passanezi; Lauris, José Roberto Pereira; Cestari, Tânia Mary

2007-01-01

Given that tobacco smoking habit is a risk factor for periodontal diseases, the aim of this study was to compare clinical periodontal aspects between smokers and non-smokers. The clinical status were assessed in 55 patients, 29 smokers and 26 non-smokers, aged 30 to 50 years, with mean age of 40. The clinical parameters used were: probing depth (PD), plaque index (PI), gingival index (GI), clinical attachment level (CAL), gingival recession (GR) and gingival bleeding index (GBI) for arches (upper and lower) and teeth (anterior and posterior). Tooth loss was also evaluated in both groups. Multiple regression analysis showed: tendency of greater probing depth and clinical attachment level means for smokers; greater amount of plaque in smokers in all regions; greater gingival index means for non-smokers with clinical significance (p<0.05) in all regions. Although, without statistical significance, the analysis showed greater gingival bleeding index means almost always for non-smokers; similar gingival recession means in both groups and tendency of upper tooth loss in smokers and lower tooth loss in non-smokers. The findings of this study showed that clinical periodontal parameters may be different in smokers when compared to non-smokers and that masking of some periodontal signs can be a result of nicotine's vasoconstrictor effect. PMID:19089190

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.

Measuring Workload Demand of Informatics Systems with the Clinical Case Demand Index

PubMed Central

Iyengar, M. Sriram; Rogith, Deevakar; Florez-Arango, Jose F

2017-01-01

Introduction: The increasing use of Health Information Technology (HIT) can add substantially to workload on clinical providers. Current methods for assessing workload do not take into account the nature of clinical cases and the use of HIT tools while solving them. Methods: The Clinical Case Demand Index (CCDI), consisting of a summary score and visual representation, was developed to meet this need. Consistency with current perceived workload measures was evaluated in a Randomized Control Trial of a mobile health system. Results: CCDI is significantly correlated with existing workload measures and inversely related to provider performance. Discussion: CCDI combines subjective and objective characteristics of clinical cases along with cognitive and clinical dimensions. Applications include evaluation of HIT tools, clinician scheduling, medical education. Conclusion: CCDI supports comparative effectiveness research of HIT tools. In addition, CCDI could have numerous applications including training, clinical trials, design of clinical workflows, and others. PMID:29854166

Axial computed tomography evaluation of the internal nasal valve correlates with clinical valve narrowing and patient complaint.

PubMed

Moche, Jason A; Cohen, Justin C; Pearlman, Steven J

2013-07-01

The objective of this work was to explore the utility of axial computed tomography (CT) imaging to objectively define a narrow internal nasal valve, and compare those findings with clinical examination and patient complaint. Retrospective review from a single facial plastic surgery center. We reviewed 40 consecutive patients evaluated for either sinusitis or nasal airway obstruction for which a CT scan was obtained at a single radiology institution. Thirty-six complete office records were examined for the presence of clinical internal valve narrowing and complaints of nasal obstruction. In total, 72 internal nasal valves were analyzed using axial plane CT and measurements were compared to clinical findings and presence of airway obstruction. Measured valve areas for clinically normal internal nasal valves averaged 0.47 cm(2) vs 0.28 cm(2) for clinically narrow valves, a decrease of 40.4%. In unobstructed nasal airways the valve area averaged 0.51 cm(2) vs 0.38 cm(2) in obstructed airways, a difference of 25.5%. A radiographically measured valve area of <0.30 cm(2) suggests clinical narrowing with a sensitivity of 71.4%, specificity of 88.9%, positive predictive value of 62.5%, and negative predictive value of 92.3%. Using standard axial CT imaging we describe an objective method of radiographically evaluating the nasal valve, demonstrating strong correlation with physical examination and patient complaint. Additionally, radiographic valve areas can be used to screen for clinically narrow nasal valves with good sensitivity and specificity, providing a novel straightforward method for nasal valve assessment. © 2012 ARS-AAOA, LLC.

Use of a cost accounting system to evaluate costs of a VA special program.

PubMed

Menke, T J; Wray, N P

1999-04-01

The Department of Veterans Affairs (VA) established six mobile clinics to provide care for rural veterans. Each was operated by a parent VA Medical Center (VAMC). To describe the use of a cost-accounting system which does not provide costs at the service or patient level to determine the costs of the mobile clinics. Costs per visit were compared among the mobile clinics with the parent VAMCs and with simulated fixed-location clinics. Cost data came from VA's Centralized Accounting for Local Management (CALM) data. Utilization data came from VA's outpatient file. Information was obtained from the VAMCs' fiscal services to reallocate costs among the CALM subaccounts to generate cost data that was comparable among the mobile clinics. Costs per visit for the mobile clinics were twice as high as those of the parent VAMCs. Costs per visit would be lower at fixed-location clinics unless the volume were substantially less than that provided by the mobile clinics. Differences between cost allocations for accounting purposes and research are likely to necessitate adjusting cost accounting data for research purposes. Fortunately, information from the accountants or primary data can lead to a cost database which is appropriate for research evaluations. In the mobile clinics study, the analysis of cost accounting data led to the conclusion that mobile clinics were not a cost-effective way in which to provide care to rural veterans.

EULAR task force recommendations on annual cardiovascular risk assessment for patients with rheumatoid arthritis: an audit of the success of implementation in a rheumatology outpatient clinic.

PubMed

Ikdahl, Eirik; Rollefstad, Silvia; Olsen, Inge C; Kvien, Tore K; Hansen, Inger Johanne Widding; Soldal, Dag Magnar; Haugeberg, Glenn; Semb, Anne Grete

2015-01-01

EULAR recommendations for cardiovascular disease (CVD) risk management include annual CVD risk assessments for patients with rheumatoid arthritis (RA). We evaluated the recording of CVD risk factors (CVD-RF) in a rheumatology outpatient clinic, where EULAR recommendations had been implemented. Further, we compared CVD-RF recordings between a regular rheumatology outpatient clinic (RegROC) and a structured arthritis clinic (AC). In 2012, 1142 RA patients visited the rheumatology outpatient clinic: 612 attended RegROC and 530 attended AC. We conducted a search in the patient journals to ascertain the rate of CVD-RF recording. The overall CVD-RF recording rate was 40.1% in the rheumatology outpatient clinic, reflecting a recording rate of 59.1% in the AC and 23.6% in the RegROC. The odds ratios for having CVD-RFs recorded for patients attending AC compared to RegROC were as follows: blood pressure: 12.4, lipids: 5.0-6.0, glucose: 9.1, HbA1c: 6.1, smoking: 1.4, and for having all the CVD-RFs needed to calculate the CVD risk by the systematic coronary risk evaluation (SCORE): 21.0. The CVD-RF recording rate was low in a rheumatology outpatient clinic. However, a systematic team-based model was superior compared to a RegROC. Further measures are warranted to improve CVD-RF recording in RA patients.

Efficacy of a botanical preparation for the intramammary treatment of clinical mastitis on an organic dairy farm

PubMed Central

Pinedo, Pablo; Karreman, Hubert; Bothe, Hans; Velez, Juan; Risco, Carlos

2013-01-01

The objective was to evaluate the efficacy of a botanical product (PHYTO-MAST®) for the intra-mammary treatment of clinical mastitis (CM) in dairy cows managed in an organic system. The study involved 194 naturally occurring cases of clinical mastitis. Treatment was applied every 12 hours for 3 days and cows were evaluated for clinical cure starting on day 4. Outcomes of interest consisted of mastitis resolution at day 4, time to resolution, somatic cell score (SCS) after recovery, and bacteriological cure at 14 and 28 d after treatment. There was no significant effect on clinical mastitis resolution at day 4 for treatment compared with the control group. However, there was a faster recovery for the treatment group compared to the control group with median intervals from end of treatment to recovery of 4.6 d and 6.5 d, respectively. There was no effect on the probability of a SCS < 4 (200 000 SC/mL) after treatment. No significant effects were found for treatment on bacteriological cure at days 14 and 28. PMID:24155432

Comparative evaluation of topographical data of dental implant surfaces applying optical interferometry and scanning electron microscopy.

PubMed

Kournetas, N; Spintzyk, S; Schweizer, E; Sawada, T; Said, F; Schmid, P; Geis-Gerstorfer, J; Eliades, G; Rupp, F

2017-08-01

Comparability of topographical data of implant surfaces in literature is low and their clinical relevance often equivocal. The aim of this study was to investigate the ability of scanning electron microscopy and optical interferometry to assess statistically similar 3-dimensional roughness parameter results and to evaluate these data based on predefined criteria regarded relevant for a favorable biological response. Four different commercial dental screw-type implants (NanoTite Certain Prevail, TiUnite Brånemark Mk III, XiVE S Plus and SLA Standard Plus) were analyzed by stereo scanning electron microscopy and white light interferometry. Surface height, spatial and hybrid roughness parameters (Sa, Sz, Ssk, Sku, Sal, Str, Sdr) were assessed from raw and filtered data (Gaussian 50μm and 5μm cut-off-filters), respectively. Data were statistically compared by one-way ANOVA and Tukey-Kramer post-hoc test. For a clinically relevant interpretation, a categorizing evaluation approach was used based on predefined threshold criteria for each roughness parameter. The two methods exhibited predominantly statistical differences. Dependent on roughness parameters and filter settings, both methods showed variations in rankings of the implant surfaces and differed in their ability to discriminate the different topographies. Overall, the analyses revealed scale-dependent roughness data. Compared to the pure statistical approach, the categorizing evaluation resulted in much more similarities between the two methods. This study suggests to reconsider current approaches for the topographical evaluation of implant surfaces and to further seek after proper experimental settings. Furthermore, the specific role of different roughness parameters for the bioresponse has to be studied in detail in order to better define clinically relevant, scale-dependent and parameter-specific thresholds and ranges. Copyright © 2017 The Academy of Dental Materials. Published by Elsevier Ltd. All rights reserved.

Surgery Clerkship Evaluations Are Insufficient for Clinical Skills Appraisal: The Value of a Medical Student Surgical Objective Structured Clinical Examination.

PubMed

Butler, Kathryn L; Hirsh, David A; Petrusa, Emil R; Yeh, D Dante; Stearns, Dana; Sloane, David E; Linder, Jeffrey A; Basu, Gaurab; Thompson, Lisa A; de Moya, Marc A

Optimal methods for medical student assessment in surgery remain elusive. Faculty- and housestaff-written evaluations constitute the chief means of student assessment in medical education. However, numerous studies show that this approach has poor specificity and a high degree of subjectivity. We hypothesized that an objective structured clinical examination (OSCE) in the surgery clerkship would provide additional data on student performance that would confirm or augment other measures of assessment. We retrospectively reviewed data from OSCEs, National Board of Medical Examiners shelf examinations, oral presentations, and written evaluations for 51 third-year Harvard Medical School students rotating in surgery at Massachusetts General Hospital from 2014 to 2015. We expressed correlations between numeric variables in Pearson coefficients, stratified differences between rater groups by one-way analysis of variance, and compared percentages with 2-sample t-tests. We examined commentary from both OSCE and clinical written evaluations through textual analysis and summarized these results in percentages. OSCE scores and clinical evaluation scores correlated poorly with each other, as well as with shelf examination scores and oral presentation grades. Textual analysis of clinical evaluation comments revealed a heavy emphasis on motivational factors and praise, whereas OSCE written comments focused on cognitive processes, patient management, and methods to improve performance. In this single-center study, an OSCE provided clinical skills data that were not captured elsewhere in the surgery clerkship. Textual analysis of faculty evaluations reflected an emphasis on interpersonal skills, rather than appraisal of clinical acumen. These findings suggest complementary roles of faculty evaluations and OSCEs in medical student assessment. Copyright © 2017 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

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.

Depression in Adults with Intellectual Disability: Symptoms and Challenging Behaviour

ERIC Educational Resources Information Center

Hurley, A. D.

2008-01-01

Background: Psychiatric evaluation of adults with intellectual disability (ID) remains complex because of limitations in verbal abilities, atypical clinical presentation and challenging behaviour. This study examines the clinical presentation of adults with depression compared with bipolar disorder, anxiety disorders and non-psychiatric control…

Psychometric Evaluation of the MMPI-2/MMPI-2-RF Restructured Clinical Scales in an Israeli Sample.

PubMed

Shkalim, Eleanor

2015-10-01

The current study cross-culturally evaluated the psychometric properties of the Minnesota Multiphasic Personality Inventory-2 (MMPI-2)/MMPI-2-Restructured Form Restructured Clinical (RC) Scales in psychiatric settings in Israel with a sample of 100 men and 133 women. Participants were administered the MMPI-2 and were rated by their therapists on a 188-item Patient Description Form. Results indicated that in most instances the RC Scales demonstrated equivalent or better internal consistencies and improved intercorrelation patterns relative to their clinical counterparts. Furthermore, external analyses revealed comparable or improved convergent validity (with the exceptions of Antisocial Behavior [RC4] and Ideas of Persecution [RC6] among men), and mostly greater discriminant validity. Overall, the findings indicate that consistent with previous findings, the RC Scales generally exhibit comparable to improved psychometric properties over the Clinical Scales. Implications of the results, limitations, and recommendations for future research are discussed. © The Author(s) 2014.

Prostate biopsies assisted by comanipulated probe-holder: first in man.

PubMed

Vitrani, Marie-Aude; Baumann, Michael; Reversat, David; Morel, Guillaume; Moreau-Gaudry, Alexandre; Mozer, Pierre

2016-06-01

A comanipulator for assisting endorectal prostate biopsies is evaluated through a first-in-man clinical trial. This lightweight system, based on conventional robotic components, possesses six degrees of freedom. It uses three electric motors and three brakes. It features a free mode, where its low friction and inertia allow for natural manipulation of the probe and a locked mode, exhibiting both a very low stiffness and a high steady-state precision. Clinical trials focusing on the free mode and the locked mode of the robot are presented. The objective was to evaluate the practical usability and performance of the robot during clinical procedures. A research protocol for a prospective randomized clinical trial has been designed. Its specific goal was to compare the accuracy of biopsies performed with and without the assistance of the comanipulator. The accuracy is compared between biopsies performed with and without the assistance of the comanipulator, across the 10 first patients included in the trial. Results show a statistically significant increase in the precision.

Interdisciplinary Team Evaluation: An Effective Method for the Diagnostic Assessment of Autism Spectrum Disorder.

PubMed

Gerdts, Jennifer; Mancini, James; Fox, Emily; Rhoads, Candace; Ward, Tracey; Easley, Erin; Bernier, Raphael A

2018-05-01

The objective of this research is to assess the feasibility of an interdisciplinary team diagnostic assessment model for autism spectrum disorder (ASD). Medical records from 366 patients evaluated for ASD at the Seattle Children's Autism Center (SCAC) were reviewed. ASD diagnostic outcomes, provider satisfaction, engagement in follow-up care, billed time, and reimbursement amounts were compared in patients evaluated through an interdisciplinary team approach (n = 91) with those seen in multidisciplinary evaluations led by either a psychologist (n = 165) or a physician (n = 110). Diagnostic determination was made in 90% of patients evaluated through the interdisciplinary team model in a single day. Rates of ASD diagnosis were similar across the 3 tracks, ranging from 61% to 72%. Demographic characteristics did not impact the likelihood of ASD diagnosis. Rates of patient follow-up care and provider satisfaction were significantly higher in interdisciplinary versus multidisciplinary teams. Interdisciplinary team evaluations billed 1.8 fewer hours yet generated more net hourly clinic income compared with psychology-led multidisciplinary evaluations. An interdisciplinary team approach, focusing on ruling-in or ruling-out ASD, was sufficient to determine ASD diagnosis in most patients seen at the SCAC Interdisciplinary teams generated more clinic income and decreased the time spent in evaluation compared with a psychology-led approach. They did so while maintaining consistency in diagnostic rates, demonstrating increased provider satisfaction and an increased likelihood of engagement in follow-up care.

Tenosynovitis US scoring systems follow synovitis and clinical scoring systems in RA and are responsive to change after biologic therapy.

PubMed

Vlad, Violeta; Berghea, Florian; Micu, Mihaela; Varzaru, Luminita; Bojinca, Mihai; Milicescu, Mihaela; Ionescu, Ruxandra; Naredo, Esperanza

2015-09-01

To investigate by ultrasonography (US) in a cohort of active RA patients starting biologic therapy the responsiveness of tenosynovitis of wrist and hands compared to the responsiveness of synovitis in a 6 month period follow-up, to compare the responsiveness of finger flexor tenosynovitis with the responsiveness of wrist extensor tenosynovitis and to describe the subclinical synovitis and tenosynovitis in RA patients in clinical remission. Fifty seven patients with active RA starting biologic therapy were included. Clinical, laboratory, and US evaluations were performed at baseline, 1, and 6 months. US evaluation included wrist and MCPs 2-5 joints, bilaterally for synovitis and extensor tendons compartments 2, 4, and 6 and finger flexors 2-5 for tenosynovitis. Eighteen US scores based on semiquantitative or binary grades were calculated at each visit. Responsiveness of synovitis and tenosynovitis scores was calculated using the standardized response mean (SRM). The responsiveness of US tenosynovitis was lower comparing with the responsiveness of US synovitis but both showed large effect of therapy. Furthermore, tenosynovitis responsiveness was similar to CRP responsiveness (SRM -0.90). Finger flexors tenosynovitis showed a higher responsiveness than extensor tenosynovitis on GS (-0.94 compared to -0.63) and a lower SRM on PD (-0.56 compared to -0.85). Tenosynovitis scores remission was overlapping clinical remission according to CDAI and SDAI in 100% of cases. Overall there was less subclinical tenosynovitis than subclinical synovitis at final visit according to clinical activity indices. Tenosynovitis US scoring in RA may be as good as synovitis scoring for characterization of disease activity and responsiveness.

Efficacy of patient-specific bolus created using three-dimensional printing technique in photon radiotherapy.

PubMed

Fujimoto, Koya; Shiinoki, Takehiro; Yuasa, Yuki; Hanazawa, Hideki; Shibuya, Keiko

2017-06-01

A commercially available bolus ("commercial-bolus") does not make complete contact with the irregularly shaped patient skin. This study aims to customise a patient-specific three-dimensional (3D) bolus using a 3D printing technique ("3D-bolus") and to evaluate its clinical feasibility for photon radiotherapy. The 3D-bolus was designed using a treatment planning system (TPS) in Digital Imaging and Communications in Medicine-Radiotherapy (DICOM-RT) format, and converted to stereolithographic format for printing. To evaluate its physical characteristics, treatment plans were created for water-equivalent phantoms that were bolus-free, or had a flat-form printed 3D-bolus, a TPS-designed bolus ("virtual-bolus"), or a commercial-bolus. These plans were compared based on the percentage depth dose (PDD) and target-volume dose volume histogram (DVH) measurements. To evaluate the clinical feasibility, treatment plans were created for head phantoms that were bolus-free or had a 3D-bolus, a virtual-bolus, or a commercial-bolus. These plans were compared based on the target volume DVH. In the physical evaluation, the 3D-bolus provided effective dose coverage in the build-up region, which was equivalent to the commercial-bolus. With regard to the clinical feasibility, the air gaps were lesser with the 3D-bolus when compared to the commercial-bolus. Furthermore, the prescription dose could be delivered appropriately to the target volume. The 3D-bolus has potential use for air-gap reduction compared to the commercial-bolus and facilitates target-volume dose coverage and homogeneity improvement. A 3D-bolus produced using a 3D printing technique is comparable to a commercial-bolus applied to an irregular-shaped skin surface. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Current treatment of ocular toxoplasmosis in immunocompetent patients: A network meta-analysis.

PubMed

Zhang, Yanxia; Lin, Xiao; Lu, Fangli

2018-04-25

Ocular toxoplasmosis (OT) is the most frequent form of infectious posterior uveitis caused by the protozoan parasite Toxoplasma gondii. To evaluate the available evidence in peer-reviewed publications about the most effective therapy for OT in immunocompetent patients, herein a systematic literature search was conducted using Embase, PubMed, Google Scholar, and the Cochrane Central Register of Controlled Trials (CENTRAL) database from January 1987 to October 2017, with search terms "OT", "retinochoroiditis", "treatment", and "immunocompetent"; search filters "controlled clinical trial", "randomized clinical trial", and "clinical trial". The included studies were performed to evaluate the various treatment modalities of OT. Different treatment regimens were compared with regard to the improvement of visual acuity, the resolution of vitreous inflammation, recurrence, and side-effects. We independently extracted data and assessed eligibility and risk of bias using the preferred reporting items for systematic reviews and meta-analysis, and resolved any disagreement through discussion. A Bayesian network meta-analysis model was used to evaluate the interesting outcomes of all the interventions. Total 10 trials of treatments for OT were found to meet the inclusion criteria. Six trials of treatments including clindamycin, azithromycin, and trimethoprim-sulfamethoxazole (TMP-SMX) were compared with conventional therapy (the combination of pyrimethamine, sulfadiazine, and prednisone) for evaluation of the effect on visual acuity, vitreous inflammation, recurrence of OT, and side-effects. Two trials were compared TMP-SMX with placebo. One trial was compared azithromycin with TMP-SMX. And another trial was compared among treatments with clindamycin, P-S, TMP-SMX, and placebo. Based on our network meta-analysis, therapy with TMP-SMX seems to be an alternative treatment of OT in immunocompetent patients. Copyright © 2018 Elsevier B.V. All rights reserved.

Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma.

PubMed

Sharma, Karun V; Yarmolenko, Pavel S; Celik, Haydar; Eranki, Avinash; Partanen, Ari; Smitthimedhin, Anilawan; Kim, Aerang; Oetgen, Matthew; Santos, Domiciano; Patel, Janish; Kim, Peter

2017-11-01

To evaluate clinical feasibility and safety of magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) treatment of symptomatic osteoid osteoma and to compare clinical response with standard of care treatment. Nine subjects with radiologically confirmed, symptomatic osteoid osteoma were treated with MR-HIFU in an institutional review board-approved clinical trial. Treatment feasibility and safety were assessed. Clinical response was evaluated in terms of analgesic requirement, visual analog scale pain score, and sleep quality. Anesthesia, procedure, and recovery times were recorded. This MR-HIFU group was compared with a historical control group of 9 consecutive patients treated with radiofrequency ablation. Nine subjects (7 male, 2 female; 16 ± 6 years) were treated with MR-HIFU without technical difficulties or any serious adverse events. There was significant decrease in their median pain scores 4 weeks within treatment (6 vs 0, P < .01). Total pain resolution and cessation of analgesics were achieved in 8 of 9 patients after 4 weeks. In the radiofrequency ablation group, 9 patients (8 male, 1 female; 10 ± 6 years) were treated in routine clinical practice. All 9 demonstrated complete pain resolution and cessation of medications by 4 weeks with a significant decrease in median pain scores (9 vs 0, P < .001). One developed a second-degree skin burn, but there were no other adverse events. Procedure times and treatment charges were comparable between the 2 groups. This pilot study shows that MR-HIFU treatment of osteoid osteoma refractory to medical therapy is feasible and can be performed safely in pediatric patients. Clinical response is comparable with standard of care treatment but without any incisions or exposure to ionizing radiation. ClinicalTrials.govNCT02349971. Copyright © 2017 Elsevier Inc. All rights reserved.

The Dutch Hospital Standardised Mortality Ratio (HSMR) method and cardiac surgery: benchmarking in a national cohort using hospital administration data versus a clinical database

PubMed Central

Siregar, S; Pouw, M E; Moons, K G M; Versteegh, M I M; Bots, M L; van der Graaf, Y; Kalkman, C J; van Herwerden, L A; Groenwold, R H H

2014-01-01

Objective To compare the accuracy of data from hospital administration databases and a national clinical cardiac surgery database and to compare the performance of the Dutch hospital standardised mortality ratio (HSMR) method and the logistic European System for Cardiac Operative Risk Evaluation, for the purpose of benchmarking of mortality across hospitals. Methods Information on all patients undergoing cardiac surgery between 1 January 2007 and 31 December 2010 in 10 centres was extracted from The Netherlands Association for Cardio-Thoracic Surgery database and the Hospital Discharge Registry. The number of cardiac surgery interventions was compared between both databases. The European System for Cardiac Operative Risk Evaluation and hospital standardised mortality ratio models were updated in the study population and compared using the C-statistic, calibration plots and the Brier-score. Results The number of cardiac surgery interventions performed could not be assessed using the administrative database as the intervention code was incorrect in 1.4–26.3%, depending on the type of intervention. In 7.3% no intervention code was registered. The updated administrative model was inferior to the updated clinical model with respect to discrimination (c-statistic of 0.77 vs 0.85, p<0.001) and calibration (Brier Score of 2.8% vs 2.6%, p<0.001, maximum score 3.0%). Two average performing hospitals according to the clinical model became outliers when benchmarking was performed using the administrative model. Conclusions In cardiac surgery, administrative data are less suitable than clinical data for the purpose of benchmarking. The use of either administrative or clinical risk-adjustment models can affect the outlier status of hospitals. Risk-adjustment models including procedure-specific clinical risk factors are recommended. PMID:24334377

Pre- and postoperative evaluation of patients with lumbosacral disc herniation by neurophysiological and clinical assessment.

PubMed

Wojtysiak, Magdalena; Huber, Juliusz; Wiertel-Krawczuk, Agnieszka; Szymankiewicz-Szukała, Agnieszka; Moskal, Jakub; Janicki, Jacek

2014-10-01

The application of complex neurophysiological examination including motor evoked potentials (MEP) for pre- and postoperative evaluation of patients experiencing acute sciatica. The assessment of sensitivity and specificity of needle electromyography, MEP, and H-reflex examinations. The comparative analysis of preoperative and postoperative neurophysiological examination. In spite of the fact that complex neurophysiological diagnostic tools seem to be important for interpretation of incompatible results of neuroimaging and clinical examination, especially in the patients qualified for surgical treatment, their application has never been completely analyzed and documented. Pre- and postoperative electromyography, electroneurography, F-waves, H-reflex, and MEP examination were performed in 23 patients with confirmed disc-root conflict at lumbosacral spine. Clinical evaluation included examination of sensory perception for L5-S1 dermatomes, muscles strength with Lovett's scale, deep tendon reflexes, pain intensity with visual analogue scale, and straight leg raising test. Sensitivity of electromyography at rest and MEP examination for evaluation of L5-S1 roots injury was 22% to 63% and 31% to 56% whereas specificity was 71% to 83% and 57% to 86%, respectively. H-reflex sensitivity and specificity for evaluation of S1 root injury were 56% and 67%, respectively. A significant improvement of root latency parameter in postoperative MEP studies as compared with preoperative was recorded for L5 (P = 0.039) and S1 root's levels (P = 0.05). The analysis of the results from neurophysiological tests together with neuroimaging and clinical examination allow for a precise preoperative indication of the lumbosacral roots injury and accurate postoperative evaluation of patients experiencing sciatica. 3.

Tribal Benefits Counseling Program: Expanding Health Care Opportunities for Tribal Members

PubMed Central

Friedsam, Donna; Haug, Gretchen; Rust, Mike; Lake, Amy

2003-01-01

American Indian tribal clinics hired benefits counselors to increase the number of patients with public and private insurance coverage, expand the range of health care options available to tribal members, and increase third-party revenues for tribal clinics. Benefits counselors received intensive training, technical assistance, and evaluation over a 2-year period. Six tribal clinics participated in the full training program, including follow-up, process evaluation, and outcomes reporting. Participating tribal sites experienced a 78% increase in Medicaid enrollment among pregnant women and children, compared with a 26% enrollment increase statewide during the same period. Trained benefits counselors on-site at tribal clinics can substantially increase third-party insurance coverage among patients. PMID:14534213

A proposed model for economic evaluations of major depressive disorder.

PubMed

Haji Ali Afzali, Hossein; Karnon, Jonathan; Gray, Jodi

2012-08-01

In countries like UK and Australia, the comparability of model-based analyses is an essential aspect of reimbursement decisions for new pharmaceuticals, medical services and technologies. Within disease areas, the use of models with alternative structures, type of modelling techniques and/or data sources for common parameters reduces the comparability of evaluations of alternative technologies for the same condition. The aim of this paper is to propose a decision analytic model to evaluate long-term costs and benefits of alternative management options in patients with depression. The structure of the proposed model is based on the natural history of depression and includes clinical events that are important from both clinical and economic perspectives. Considering its greater flexibility with respect to handling time, discrete event simulation (DES) is an appropriate simulation platform for modelling studies of depression. We argue that the proposed model can be used as a reference model in model-based studies of depression improving the quality and comparability of studies.

Instruments evaluating the quality of the clinical learning environment in nursing education: A systematic review of psychometric properties.

PubMed

Mansutti, Irene; Saiani, Luisa; Grassetti, Luca; Palese, Alvisa

2017-03-01

The clinical learning environment is fundamental to nursing education paths, capable of affecting learning processes and outcomes. Several instruments have been developed in nursing education, aimed at evaluating the quality of the clinical learning environments; however, no systematic review of the psychometric properties and methodological quality of these studies has been performed to date. The aims of the study were: 1) to identify validated instruments evaluating the clinical learning environments in nursing education; 2) to evaluate critically the methodological quality of the psychometric property estimation used; and 3) to compare psychometric properties across the instruments available. A systematic review of the literature (using the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines) and an evaluation of the methodological quality of psychometric properties (using the COnsensus-based Standards for the selection of health Measurement INstruments guidelines). The Medline and CINAHL databases were searched. Eligible studies were those that satisfied the following criteria: a) validation studies of instruments evaluating the quality of clinical learning environments; b) in nursing education; c) published in English or Italian; d) before April 2016. The included studies were evaluated for the methodological quality of the psychometric properties measured and then compared in terms of both the psychometric properties and the methodological quality of the processes used. The search strategy yielded a total of 26 studies and eight clinical learning environment evaluation instruments. A variety of psychometric properties have been estimated for each instrument, with differing qualities in the methodology used. Concept and construct validity were poorly assessed in terms of their significance and rarely judged by the target population (nursing students). Some properties were rarely considered (e.g., reliability, measurement error, criterion validity), whereas others were frequently estimated, but using different coefficients and statistical analyses (e.g., internal consistency, structural validity), thus rendering comparison across instruments difficult. Moreover, the methodological quality adopted in the property assessments was poor or fair in most studies, compromising the goodness of the psychometric values estimated. Clinical learning placements represent the key strategies in educating the future nursing workforce: instruments evaluating the quality of the settings, as well as their capacity to promote significant learning, are strongly recommended. Studies estimating psychometric properties, using an increased quality of research methodologies are needed in order to support nursing educators in the process of clinical placements accreditation and quality improvement. Copyright © 2017 Elsevier Ltd. All rights reserved.

Quantifying learning in medical students during a critical care medicine elective: a comparison of three evaluation instruments.

PubMed

Rogers, P L; Jacob, H; Rashwan, A S; Pinsky, M R

2001-06-01

To compare three different evaluative instruments and determine which is able to measure different aspects of medical student learning. Student learning was evaluated by using written examinations, objective structured clinical examination, and patient simulator that used two clinical scenarios before and after a structured critical care elective, by using a crossover design. Twenty-four 4th-yr students enrolled in the critical care medicine elective. All students took a multiple-choice written examination; evaluated a live simulated critically ill patient, requested data from a nurse, and intervened as appropriate at different stations (objective structured clinical examination); and evaluated the computer-controlled patient simulator and intervened as appropriate. Students' knowledge was assessed by using a multiple-choice examination containing the same data incorporated into the other examinations. Student performance on the objective structured clinical examination was evaluated at five stations. Both objective structured clinical examination and simulator tests were videotaped for subsequent scores of responses, quality of responses, and response time. The videotapes were reviewed for specific behaviors by faculty masked to time of examination. Students were expected to perform the following: a) assess airway, breathing, and circulation; b) prepare a mannequin for intubation; c) provide appropriate ventilator settings; d) manage hypotension; and e) request, interpret, and provide appropriate intervention for pulmonary artery catheter data. Students were expected to perform identical behaviors during the simulator examination; however, the entire examination was performed on the whole-body computer-controlled mannequin. The primary outcome measure was the difference in examination scores before and after the rotation. The mean preelective scores were 77 +/- 16%, 47 +/- 15%, and 41 +/- 14% for the written examination, objective structured clinical examination, and simulator, respectively, compared with 89 +/- 11%, 76 +/- 12%, and 62 +/- 15% after the elective (p <.0001). Prerotation scores for the written examination were significantly higher than the objective structured clinical examination or the simulator; postrotation scores were highest for the written examination and lowest for the simulator. Written examinations measure acquisition of knowledge but fail to predict if students can apply knowledge to problem solving, whereas both the objective structured clinical examination and the computer-controlled patient simulator can be used as effective performance evaluation tools.

Comparison of everolimus- and paclitaxel-eluting stents in patients with acute and stable coronary syndromes: pooled results from the SPIRIT (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) Trials.

PubMed

Planer, David; Smits, Pieter C; Kereiakes, Dean J; Kedhi, Elvin; Fahy, Martin; Xu, Ke; Serruys, Patrick W; Stone, Gregg W

2011-10-01

This study sought to compare the clinical outcomes of everolimus-eluting stents (EES) versus paclitaxel-eluting stents (PES) in patients with acute coronary syndromes (ACS) and stable coronary artery disease (CAD). Although randomized trials have shown superiority of EES to PES, the safety and efficacy of EES in ACS is unknown. We performed a patient-level pooled analysis from the prospective, randomized SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) II, III, IV, and COMPARE (A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice) trials in which 2,381 patients with ACS and 4,404 patients with stable CAD were randomized to EES or to PES. Kaplan-Meier estimates of death, myocardial infarction (MI), ischemia-driven target lesion revascularization, and stent thrombosis were assessed at 2 years and stratified by clinical presentation (ACS vs. stable CAD). At 2 years, patients with ACS compared with stable CAD had higher rates of death (3.2% vs. 2.4%, hazard ratio [HR]: 1.37 [95% confidence interval (CI): 1.02 to 1.85], p = 0.04) and MI (4.9% vs. 3.4%, HR: 1.45 [95% CI: 1.14 to 1.85], p = 0.02). In patients with ACS, EES versus PES reduced the rate of death or MI (6.6% vs. 9.3%, HR: 0.70 [95% CI: 0.52 to 0.94], p = 0.02), stent thrombosis (0.7% vs. 2.9%, HR: 0.25 [95% CI: 0.12 to 0.52], p = 0.0002), and ischemia-driven target lesion revascularization (4.7% vs. 6.2%, HR: 0.69 [95% CI: 0.48 to 0.99], p = 0.04). In patients with stable CAD, EES reduced the rate of death or MI (4.5% vs. 7.1%, HR: 0.62 [95% CI: 0.48 to 0.80], p = 0.0002), stent thrombosis (0.7% vs. 1.8%, HR: 0.34 [95% CI: 0.19 to 0.62], p = 0.0002), and ischemia-driven target lesion revascularization (3.9% vs. 6.9%, HR: 0.55 [95% CI: 0.42 to 0.73], p < 0.0001). Treatment with EES versus PES provides enhanced safety and efficacy regardless of the acuity of the clinical syndrome being treated and appears to mitigate the increased risk of stent thrombosis associated with ACS. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions [SPIRIT II]; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT III]; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions [SPIRIT IV]; NCT00307047; A Trial of Everolimus-Eluting Stents and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice: the COMPARE Trial [COMPARE]; NCT01016041). Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Clinical evaluation of subepithelial connective tissue graft and guided tissue regeneration for treatment of Miller’s class 1 gingival recession (comparative, split mouth, six months study)

PubMed Central

Bhavsar, Neeta-V.; Dulani, Kirti; Trivedi, Rahul

2014-01-01

Objectives: The present study aims to clinically compare and evaluate subepithelial connective tissue graft and the GTR based root coverage in treatment of Miller’s Class I gingival recession. Study Design: 30 patients with at least one pair of Miller’s Class I gingival recession were treated either with Subepithelial connective tissue graft (Group A) or Guided tissue regeneration (Group B). Clinical parameters monitored included recession RD, width of keratinized gingiva (KG), probing depth (PD), clinical attachment level (CAL), attached gingiva (AG), residual probing depth (RPD) and % of Root coverage(%RC). Measurements were taken at baseline, three months and six months. A standard surgical procedure was used for both Group A and Group B. Data were recorded and statistical analysis was done for both intergroup and intragroup. Results: At end of six months % RC obtained were 84.47% (Group A) and 81.67% (Group B). Both treatments resulted in statistically significant improvement in clinical parameters. When compared, no statistically significant difference was found between both groups except in RPD, where it was significantly greater in Group A. Conclusions: GTR technique has advantages over subepithelial connective tissue graft for shallow Miller’s Class I defects and this procedure can be used to avoid patient discomfort and reduce treatment time. Key words:Collagen membrane, comparative split mouth study, gingival recession, subepithelial connective tissue graft, guided tissue regeneration (GTR). PMID:25136420

Development and evaluation of a clinical model for lung cancer patients using stereotactic body radiotherapy (SBRT) within a knowledge-based algorithm for treatment planning.

PubMed

Chin Snyder, Karen; Kim, Jinkoo; Reding, Anne; Fraser, Corey; Gordon, James; Ajlouni, Munther; Movsas, Benjamin; Chetty, Indrin J

2016-11-08

The purpose of this study was to describe the development of a clinical model for lung cancer patients treated with stereotactic body radiotherapy (SBRT) within a knowledge-based algorithm for treatment planning, and to evaluate the model performance and applicability to different planning techniques, tumor locations, and beam arrangements. 105 SBRT plans for lung cancer patients previously treated at our institution were included in the development of the knowledge-based model (KBM). The KBM was trained with a combination of IMRT, VMAT, and 3D CRT techniques. Model performance was validated with 25 cases, for both IMRT and VMAT. The full KBM encompassed lesions located centrally vs. peripherally (43:62), upper vs. lower (62:43), and anterior vs. posterior (60:45). Four separate sub-KBMs were created based on tumor location. Results were compared with the full KBM to evaluate its robustness. Beam templates were used in conjunction with the optimizer to evaluate the model's ability to handle suboptimal beam placements. Dose differences to organs-at-risk (OAR) were evaluated between the plans gener-ated by each KBM. Knowledge-based plans (KBPs) were comparable to clinical plans with respect to target conformity and OAR doses. The KBPs resulted in a lower maximum spinal cord dose by 1.0 ± 1.6 Gy compared to clinical plans, p = 0.007. Sub-KBMs split according to tumor location did not produce significantly better DVH estimates compared to the full KBM. For central lesions, compared to the full KBM, the peripheral sub-KBM resulted in lower dose to 0.035 cc and 5 cc of the esophagus, both by 0.4Gy ± 0.8Gy, p = 0.025. For all lesions, compared to the full KBM, the posterior sub-KBM resulted in higher dose to 0.035 cc, 0.35 cc, and 1.2 cc of the spinal cord by 0.2 ± 0.4Gy, p = 0.01. Plans using template beam arrangements met target and OAR criteria, with an increase noted in maximum heart dose (1.2 ± 2.2Gy, p = 0.01) and GI (0.2 ± 0.4, p = 0.01) for the nine-field plans relative to KBPs planned with custom beam angles. A knowledge-based model for lung SBRT consisting of multiple treatment modalities and lesion loca-tions produced comparable plan quality to clinical plans. With proper training and validation, a robust KBM can be created that encompasses both IMRT and VMAT techniques, as well as different lesion locations. © 2016 The Authors.

Self-verification in clinical depression: the desire for negative evaluation.

PubMed

Giesler, R B; Josephs, R A; Swann, W B

1996-08-01

Do clinically depressed individuals seek favorable or unfavorable information about the self? Self-verification theory makes the counterintuitive prediction that depressed individuals solicit feedback that confirms their negative self-views. To test this prediction, participants were classified on the basis of a structured clinical interview and self-report measures into high-esteem, low self-esteem, and depressed groups. All participants were offered a choice between receiving favorable or unfavorable feedback; 82% of the depressed participants chose the unfavorable feedback, compared to 64% of the low self-esteem participants and 25% of the high self-esteem participants. Additional evidence indicated that depressed individuals also failed to exploit fully an opportunity to acquire favorable evaluations that were self-verifying. The authors discuss how seeking negative evaluations and failing to seek favorable evaluations may help maintain depression.

Clinical and Other Risk Indicators for Early Periodontitis in Adults

PubMed Central

Tanner, Anne C.R.; Kent, Ralph; Van Dyke, Thomas; Sonis, Steven T.; Murray, Lora A.

2005-01-01

Background Periodontal diseases affect over half the adults in the U.S., disproportionately affecting minority populations. Periodontitis can be treated in early stages, but it is not clear what features indicate, or could be risk factors for, early stages of periodontal attachment loss. This study aimed to evaluate associations between clinical and other risk indicators of early periodontitis. Methods A cross-sectional evaluation of 225 healthy and early periodontitis adults aged 20 to 40 years was performed. Clinical measurements, demographic information, and smoking histories were recorded. Analyses evaluated demographic and clinical associations with health and early periodontitis disease categories and periodontal attachment loss. Patterns of attachment loss at interproximal and buccal/lingual sites were evaluated. Results Subject age, plaque, and measures of gingivitis exhibited associations with attachment loss and probing depth. More periodontal attachment loss was detected in African-American and Hispanic subjects compared to Asian and Caucasian subjects. Smoking history was associated with attachment loss. At interproximal sites, lower molars most frequently had attachment loss, whereas at buccal/lingual sites, higher proportions of lower bicuspid teeth demonstrated attachment loss compared with other sites. Conclusions In this study of subjects with minimal attachment loss, gingival inflammation was associated with early periodontitis. Lower molar interproximal sites were frequently associated with interproximal attachment loss, whereas lower bicuspid teeth were at risk for gingival recession on buccal surfaces. PMID:15857098

Oxidized zirconium versus cobalt-chromium against the native patella in total knee arthroplasty: Patellofemoral outcomes.

PubMed

Matassi, Fabrizio; Paoli, Tommaso; Civinini, Roberto; Carulli, Christian; Innocenti, Massimo

2017-10-01

Oxidized zirconium (OxZr) has demonstrated excellent mechanical properties in vitro when used against articular cartilage; less coefficient of friction and less chondral damage have been found when compared with cobalt-chromium (CoCr) implants. However, controversy exists as to whether implants with a zirconium femoral component articulate safely with a native patella in total knee arthroplasty (TKA). To answer this question, the clinical and radiographic results were analysed from a group of patients who underwent a TKA with patella retention; the OxZr versus CoCr femoral components were compared. The present study prospectively evaluated 83 knees of 74 patients from 2009 to 2010. Each patient was evaluated clinically (visual analogue scale, Knee Society score, patellar score) and radiographically (long leg standing radiograph, anterior-posterior and latero-lateral projections, axial view of the patella) pre-operatively and postoperatively with a mean follow-up of 4.47years. The patellar tilt and shift, and progression of patellofemoral osteoarthritis were calculated with the axial view. There were no patient reported adverse reactions and none of the evaluated prostheses failed. Both the clinical and radiographic evaluations showed no statistically significant between-group differences. No adverse events were observed clinically or radiologically. These results justify pursuing the use of oxidized zirconium as an alternative bearing surface for a femoral component associated with patellar retention in TKA. Published by Elsevier B.V.

Structured reports of videofluoroscopic swallowing studies have the potential to improve overall report quality compared to free text reports.

PubMed

Schoeppe, Franziska; Sommer, Wieland H; Haack, Mareike; Havel, Miriam; Rheinwald, Marika; Wechtenbruch, Juliane; Fischer, Martin R; Meinel, Felix G; Sabel, Bastian O; Sommer, Nora N

2018-01-01

To compare free text (FTR) and structured reports (SR) of videofluoroscopic swallowing studies (VFSS) and evaluate satisfaction of referring otolaryngologists and speech therapists. Both standard FTR and SR of 26 patients with VFSS were acquired. A dedicated template focusing on oropharyngeal phases was created for SR using online software with clickable decision-trees and concomitant generation of semantically structured reports. All reports were evaluated regarding overall quality and content, information extraction and clinical decision support (10-point Likert scale (0 = I completely disagree, 10 = I completely agree)). Two otorhinolaryngologists and two speech therapists evaluated FTR and SR. SR received better ratings than FTR in all items. SR were perceived to contain more details on the swallowing phases (median rating: 10 vs. 5; P < 0.001), penetration and aspiration (10 vs. 5; P < 0.001) and facilitated information extraction compared to FTR (10 vs. 4; P < 0.001). Overall quality was rated significantly higher in SR than FTR (P < 0.001). SR of VFSS provide more detailed information and facilitate information extraction. SR better assist in clinical decision-making, might enhance the quality of the report and, thus, are recommended for the evaluation of VFSS. • Structured reports on videofluoroscopic exams of deglutition lead to improved report quality. • Information extraction is facilitated when using structured reports based on decision trees. • Template-based reports add more value to clinical decision-making than free text reports. • Structured reports receive better ratings by speech therapists and otolaryngologists. • Structured reports on videofluoroscopic exams may improve the comparability between exams.

Evaluation of meniscus tears of the knee by radionuclide imaging

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

Marymont, J.V.; Lynch, M.A.; Henning, C.E.

We compare the accuracy of radionuclide imaging of the knee with Tc99m-pyrophosphate with arthrography for the evaluation of meniscus tears in young athletes with clinically suspected knee injury. All patients had arthroscopy which was used as the standard against which the other two diagnostic procedures were compared. Radionuclide scintigraphy and arthrography were comparable in their ability to detect tears of the medial meniscus. Scintigraphy was superior for the detection of tears of the lateral meniscus and of both menisci.

The Effect of Anxiety, Depression, and Optimism on Postoperative Satisfaction and Clinical Outcomes in Lumbar Spinal Stenosis and Degenerative Spondylolisthesis Patients: Cohort Study.

PubMed

Lee, Jaewon; Kim, Hong-Sik; Shim, Kyu-Dong; Park, Ye-Soo

2017-06-01

The aim of this study is to evaluate the effect of depression, anxiety, and optimism on postoperative satisfaction and clinical outcomes in patients who underwent less than two-level posterior instrumented fusions for lumbar spinal stenosis and degenerative spondylolisthesis. Preoperative psychological status of subjects, such as depression, anxiety, and optimism, was evaluated using the Hospital Anxiety and Depression Scale (HADS) and the Revised Life Orientation Test (LOT-R). Clinical evaluation was determined by measuring changes in a visual analogue scale (VAS) and the Oswestry Disability Index (ODI) before and after surgery. Postoperative satisfaction of subjects assessed using the North American Spine Society lumbar spine questionnaire was comparatively analyzed against the preoperative psychological status. The correlation between patient's preoperative psychological status (depression, anxiety, and optimism) and clinical outcomes (VAS and ODI) was evaluated. VAS and ODI scores significantly decreased after surgery ( p < 0.001), suggesting clinically favorable outcomes. Preoperative psychological status of patients (anxiety, depression, and optimism) was not related to the degree of improvement in clinical outcomes (VAS and ODI) after surgery. However, postoperative satisfaction was moderately correlated with optimism. Anxiety and optimism were more correlated with patient satisfaction than clinical outcomes. Accordingly, the surgeon can predict postoperative satisfaction of patients based on careful evaluation of psychological status before surgery.

Micrometastases in neuroblastoma: are they clinically important?

PubMed Central

Burchill, S A

2004-01-01

Despite advances in the treatment of neuroblastoma (NBL), recurrence and metastases continue to pose major problems in clinical management. The relation between micrometastases and the development of secondary disease is not fully understood. However, accurate methods to detect low numbers of tumour cells may allow the evaluation of their role in the disease process, and by implication the possible benefits of eliminating them. Although there is substantial evidence for the increased sensitivity of current molecular methods for the detection of NBL cells compared with more conventional cytology, the clinical relevance and usefulness of detecting this disease remain controversial. The primary goal of current translational research must be to evaluate the clinical relevance of micrometastatic disease detected by these methods in multicentre prospective clinical outcome studies. Only then can the clinical usefulness of these methods be defined so that they may be introduced into relevant clinical practice. PMID:14693828

A systematic review of model-based economic evaluations of diagnostic and therapeutic strategies for lower extremity artery disease.

PubMed

Vaidya, Anil; Joore, Manuela A; ten Cate-Hoek, Arina J; Kleinegris, Marie-Claire; ten Cate, Hugo; Severens, Johan L

2014-01-01

Lower extremity artery disease (LEAD) is a sign of wide spread atherosclerosis also affecting coronary, cerebral and renal arteries and is associated with increased risk of cardiovascular events. Many economic evaluations have been published for LEAD due to its clinical, social and economic importance. The aim of this systematic review was to assess modelling methods used in published economic evaluations in the field of LEAD. Our review appraised and compared the general characteristics, model structure and methodological quality of published models. Electronic databases MEDLINE and EMBASE were searched until February 2013 via OVID interface. Cochrane database of systematic reviews, Health Technology Assessment database hosted by National Institute for Health research and National Health Services Economic Evaluation Database (NHSEED) were also searched. The methodological quality of the included studies was assessed by using the Philips' checklist. Sixteen model-based economic evaluations were identified and included. Eleven models compared therapeutic health technologies; three models compared diagnostic tests and two models compared a combination of diagnostic and therapeutic options for LEAD. Results of this systematic review revealed an acceptable to low methodological quality of the included studies. Methodological diversity and insufficient information posed a challenge for valid comparison of the included studies. In conclusion, there is a need for transparent, methodologically comparable and scientifically credible model-based economic evaluations in the field of LEAD. Future modelling studies should include clinically and economically important cardiovascular outcomes to reflect the wider impact of LEAD on individual patients and on the society.

[Role of the gastroenterologist in the fate of the functional gastrointestinal patient. Comparative evaluation in 2 series of patients in the outpatient clinic of the Social Security Gastroenterology department of Barquisimeto].

PubMed

Nazareno Pifano, F

1977-01-01

A comparative evaluation is made of patients with functional digestive diseases in an out-patient clinic of the Social Security of Barquisimeto. In the first group of patients a routine approach was followed while in the second group a brief biographic history is added adapting it to the circumstances of work that exist within this type of clinic. From the information obtained of the destiny of the patients of each group, it is evident that the total approach to the patient is of importance as the only mean possible for an adequate approximation to the patient and the proper management of the case. The problem is presented of the gastroenterologist, overwhelmed by the great technical progress, confronted by the destiny of the functional digestive patient in socialized medicine.

Spinal and temporo-mandibular disorders in male workers of the State Police.

PubMed

Sancini, Angela; Tomei, Francesco; Tomei, Gianfranco; Caciari, Tiziana; Capozzella, Assunta; Di Famiani, Manuela; Samperi, Ilaria; Scala, Barbara; Fiaschetti, Maria; Cetica, Carlotta; Ciarrocca, Manuela

2013-01-01

The aims of this study are to evaluate the prevalence of disorders of the lumbar region and the temporo-mandibular district co-morbidity in drivers and workers of the State Police employed for different office activities. The study population included 103 drivers as cases and 100 police officers as controls. The study was carried out through questionnaire and clinical evaluation of the spine and temporo-mandibular region. At clinical examination, the drivers were found to have a higher prevalence (p < 0.05) of both symptoms and clinical signs at the spine and temporo-mandibular joint (TMJ), when compared with the controls. The results also showed a higher prevalence (p < 0.05) of co-morbidity in the two districts among the drivers, when compared with the controls. These results confirm that morbidity related to back and TMJ and increase in co-morbidity between the two districts are higher in professional drivers.

Performance of two different digital evaluation systems used for assessing pre-clinical dental students' prosthodontic technical skills.

PubMed

Gratton, D G; Kwon, S R; Blanchette, D R; Aquilino, S A

2017-11-01

Proper integration of newly emerging digital assessment tools is a central issue in dental education in an effort to provide more accurate and objective feedback to students. The study examined how the outcomes of students' tooth preparation were correlated when evaluated using traditional faculty assessment and two types of digital assessment approaches. Specifically, incorporation of the Romexis Compare 2.0 (Compare) and Sirona prepCheck 1.1 (prepCheck) systems was evaluated. Additionally, satisfaction of students based on the type of software was evaluated through a survey. Students in a second-year pre-clinical prosthodontics course were allocated to either Compare (n = 42) or prepCheck (n = 37) systems. All students received conventional instruction and used their assigned digital system as an additional evaluation tool to aid in assessing their work. Examinations assessed crown preparations of the maxillary right central incisor (#8) and the mandibular left first molar (#19). All submissions were graded by faculty, Compare and prepCheck. Technical scores did not differ between student groups for any of the assessment approaches. Compare and prepCheck had modest, statistically significant correlations with faculty scores with a minimum correlation of 0.3944 (P = 0.0011) and strong, statistically significant correlations with each other with a minimum correlation of 0.8203 (P < 0.0001). A post-course student survey found that 55.26% of the students felt unfavourably about learning the digital evaluation protocols. A total of 62.31% felt favourably about the integration of these digital tools into the curriculum. Comparison of Compare and prepCheck showed no evidence of significant difference in students' prosthodontics technical performance and perception. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Two-year clinical trial of a universal adhesive in total-etch and self-etch mode in non-carious cervical lesions☆

PubMed Central

Lawson, Nathaniel C.; Robles, Augusto; Fu, Chin-Chuan; Lin, Chee Paul; Sawlani, Kanchan; Burgess, John O.

2016-01-01

Objectives To compare the clinical performance of Scotchbond™ Universal Adhesive used in self- and total-etch modes and two-bottle Scotchbond™ Multi-purpose Adhesive in total-etch mode for Class 5 non-carious cervical lesions (NCCLs). Methods 37 adults were recruited with 3 or 6 NCCLs (>1.5 mm deep). Teeth were isolated, and a short cervical bevel was prepared. Teeth were restored randomly with Scotchbond Universal total-etch, Scotchbond Universal self-etch or Scotchbond Multi-purpose followed with a composite resin. Restorations were evaluated at baseline, 6, 12 and 24 months for marginal adaptation, marginal discoloration, secondary caries, and sensitivity to cold using modified USPHS Criteria. Patients and evaluators were blinded. Logistic and linear regression models using a generalized estimating equation were applied to evaluate the effects of time and adhesive material on clinical assessment outcomes over the 24 month follow-up period. Kaplan–Meier method was used to compare the retention between adhesive materials. Results Clinical performance of all adhesive materials deteriorated over time for marginal adaptation, and discoloration (p <0.0001). Both Scotchbond Universal self-etch and Scotchbond Multi-purpose materials were more than three times as likely to contribute to less satisfying performance in marginal discoloration over time than Scotchbond Universal total-etch. The retention rates up to 24 months were 87.6%, 94.9% and 100% for Scotchbond Multi-purpose and Scotchbond Universal self-etch and total-etch, respectively. Conclusions Scotchbond Universal in self- and total- etch modes performed similar to or better than Scotchbond Multipurpose, respectively. Clinical significance 24 month evaluation of a universal adhesive indicates acceptable clinical performance, particularly in a total-etch mode. PMID:26231300

Accuracy and completeness of drug information in Wikipedia medication monographs.

PubMed

Reilly, Timothy; Jackson, William; Berger, Victoria; Candelario, Danielle

The primary objective of this study was to determine the accuracy and completeness of drug information on Wikipedia and Micromedex compared with U.S. Food and Drug Administration-approved U.S. product inserts. The top 10 brand and top 10 generic medications from the 2012 Institute for Health Informatics' list of top 200 drugs were selected for evaluation. Wikipedia medication information was evaluated and compared with Micromedex in 7 sections of drug information; the U.S. product inserts were used as the standard comparator. Wikipedia demonstrated significantly lower completeness and accuracy scores compared with Micromedex (mean composite scores 18.55 vs. 38.4, respectively; P <0.01). No difference was found between the mean composite scores for brand versus generic drugs in either reference (17.8 vs. 19.3, respectively [P = 0.62], for Wikipedia; 39.2 vs. 37.6, [P = 0.06] for Micromedex). Limitations to these results include the speed with which information is edited on Wikipedia, that there was no evaluation of off-label information, and the limited number of drugs that were evaluated. Wikipedia lacks the accuracy and completeness of standard clinical references and should not be a routine part of clinical decision making. More research should be conducted to evaluate the rationale for health care providers' use of Wikipedia. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Outcome methods used in clinical studies of Chiari malformation Type I: a systematic review.

PubMed

Greenberg, Jacob K; Milner, Eric; Yarbrough, Chester K; Lipsey, Kim; Piccirillo, Jay F; Smyth, Matthew D; Park, Tae Sung; Limbrick, David D

2015-02-01

Chiari malformation Type I (CM-I) is a common and often debilitating neurological disease. Efforts to improve treatment of CM-I are impeded by inconsistent and limited methods of evaluating clinical outcomes. To understand current approaches and lay a foundation for future research, the authors conducted a systematic review of the methods used in original published research articles to evaluate clinical outcomes in patients treated for CM-I. The authors searched PubMed, Embase, the Cumulative Index to Nursing and Allied Health Literature, ClinicalTrials.gov , and Cochrane databases to identify publications between January 2003 and August 2013 that met the following criteria: 1) reported clinical outcomes in patients treated for CM-I; 2) were original research articles; 3) included at least 10 patients or, if a comparative study, at least 5 patients per group; and 4) were restricted to patients with CM-I. Among the 74 papers meeting inclusion criteria, there was wide variation in the outcome methods used. However, all approaches were broadly grouped into 3 categories: 1) "gestalt" impression of overall symptomatic improvement (n=45 papers); 2) postoperative change in specific signs or symptoms (n=20); or 3) results of various standardized assessment scales (n=22). Among standardized scales, 11 general function measures were used, compared with 6 disease-specific tools. Only 3 papers used scales validated in patients with CM-I. To facilitate a uniform comparison of these heterogeneous approaches, the authors appraised articles in multiple domains defined a priori as integral to reporting clinical outcomes in CM-I. Notably, only 7 articles incorporated patient-response instruments when reporting outcome, and only 22 articles explicitly assessed quality of life. The methods used to evaluate clinical outcomes in CM-I are inconsistent and frequently not comparable, complicating efforts to analyze results across studies. Development, validation, and incorporation of a small number of disease-specific patient-based instruments will improve the quality of research and care of CM-I patients.

Pneumonia due to Pseudomonas aeruginosa: the levofloxacin clinical trials experience.

PubMed

Tennenberg, Alan M; Davis, Neelam B; Wu, Shu-Chen; Kahn, James

2006-05-01

Respiratory infections caused by Pseudomonas aeruginosa present significant treatment challenges, including that of overcoming intrinsic and adaptive resistance by these organisms. The fluoroquinolones may provide an effective option for treating these infections. In this analysis, we report on the efficacy of levofloxacin in the treatment of community-acquired pneumonia (CAP) and nosocomial pneumonia caused by P. aeruginosa using information from nine clinical studies supported by Johnson & Johnson Pharmaceutical Research and Development (Raritan, NJ) or Ortho-McNeil Pharmaceutical (Raritan, NJ). From these studies, a total of 36 patients were identified with pneumonia caused by P. aeruginosa and treated with levofloxacin (750 mg or 500 mg). For patients diagnosed with nosocomial pneumonia, levofloxacin treatment achieved a 64.7% (11/17) clinical success rate, compared with 41.2% (7/17) with comparator treatment (imipenem/cilastatin followed by ciprofloxacin) in the microbiologically evaluable population. Eradication rates were 58.8% with levofloxacin treatment vs. 29.4% with comparator (95% CI, -64.2 to 5.4). For levofloxacin-treated CAP patients with P. aeruginosa infections (n = 19), clinical success and microbiological eradication rates in the microbiologically evaluable population were 89.5% and 78.9%, respectively. Several limitations of this analysis exist including that this was a retrospective evaluation that pooled data from multiple studies with varying protocols, the number of patients included was limited, and the nosocomial pneumonia patients used adjunctive therapy with an antipseudomonal beta-lactam in most cases. Nonetheless, these findings suggest that levofloxacin may play a role in the treatment of these difficult respiratory infections.

[The evaluation of costs: standards of medical care and clinical statistic groups].

PubMed

Semenov, V Iu; Samorodskaia, I V

2014-01-01

The article presents the comparative analysis of techniques of evaluation of costs of hospital treatment using medical economic standards of medical care and clinical statistical groups. The technique of evaluation of costs on the basis of clinical statistical groups was developed almost fifty years ago and is largely applied in a number of countries. Nowadays, in Russia the payment for completed case of treatment on the basis of medical economic standards is the main mode of payment for medical care in hospital. It is very conditionally a Russian analogue of world-wide prevalent system of diagnostic related groups. The tariffs for these cases of treatment as opposed to clinical statistical groups are counted on basis of standards of provision of medical care approved by Minzdrav of Russia. The information derived from generalization of cases of treatment of real patients is not applied.

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

Are We Using Slow-Acting Symptomatic Chondroprotective Drugs Conscious Enough?

PubMed

Gumustas, Seyit Ali; Oznam, Kadir; Mutlu, Cagri Ata; Kaya, Yasin Emre; Yilmaz, Ibrahim; Isyar, Mehmet; Guzelant, Aliye Yıldırım; Guler, Olcay; Akkaya, Semih; Mahirogullari, Mahir

2017-01-01

Osteochondral injuries constitute an entity that is widespread and can be seen in patients of all ages. Actual treatment modalities aim to relieve pain, obtain full range of movement of the joint, and improve the quality of life. There are many slow-acting chondroprotective agents prevalently used in the United States that are classified as nutritional support but not as medicines . This study presents the importance of clinical adverse effect profiles as well as the pharmacological mechanism of action and application of combinations of drugs that are widely prescribed and not subjected to control. Electronic databases were searched with keywords about the chondroprotective drugs without any language restriction. Evaluations of the descriptive statistics were represented via Microsoft Office Excel 2010 lists in the form of a mean±standard deviation or frequency (%). The first evaluation showed that 1502 studies were potentially relevant. Following exclusion of the 1277 studies which were not clinical, full versions of the remaining 225 studies were subjected to further evaluation. No controlled, blinded, randomized and/or comparative studies met the inclusion criteria of the study, and no studies evaluated the comparative clinical results of the hyaluronan of different molecular weights. The findings of this study concluded that especially when prescribing drugs with ingredients like GS and CS, many patients' pre-existing conditions must be considered, such as whether the patient has a glucose intolerance or not. Additionally, mineral toxication should be considered since the drugs contain minerals, and after the application of injected hyaluronan, complications should be considered. Clinical, controlled and comparative studies about the use of chondroprotective drugs must be performed to define the benefits of these drugs, if any, in order to determine the most suitable time for operative intervention.

Allogeneic cultured keratinocytes vs. cadaveric skin to cover wide-mesh autogenous split-thickness skin grafts.

PubMed

Monstrey, S; Beele, H; Kettler, M; Van Landuyt, K; Blondeel, P; Matton, G; Naeyaert, J M

1999-09-01

Improved shock therapy has extended the limits of survival in patients with massive burns, and nowadays skin coverage has become the major problem in burn management. The use of mesh skin grafts is still the simplest technique to expand the amount of available donor skin. However, very wide-mesh skin grafts take a very long time to heal, often resulting in unaesthetic scar formation. On the other hand, allogeneic cultured keratinocytes have been reported as a natural source of growth factors and thus could be useful to improve wound healing of these wide-mesh grafts. A clinical study was performed to compare the use of cryopreserved allogeneic cultured keratinocytes vs. the traditional cadaveric skin as a double layer over widely expanded autogenous skin grafts. This procedure was performed in 18 pairs of full-thickness burn wounds (with similar depth and location) in 11 severely burned patients. Early clinical evaluation was made at 2, 3, and 4 to 5 weeks. Parameters such as epithelialization, granulation tissue formation, infection, and scar formation were evaluated. Biopsies were taken to compare the histological characteristics of the epidermis, the epidermal-dermal junction, and the dermis. Late evaluations were performed at 6 and 12 months regarding color, softness, thickness, and subjective feeling of the scar tissue. Aside from a faster (p < 0.05) epithelialization in the keratinocyte group at 2 weeks, there were no statistically different results in any of the early evaluated parameters, neither clinically nor histologically. At long-term follow-up, clinical results and scar characteristics were not significantly different in the two compared groups. It is concluded from the results of this study that, during the early phase, epithelialization was faster with allogeneic cultured keratinocytes compared with cadaveric skin. However, taking into account the substantial difference in costs, the described use of cryopreserved allogeneic cultured keratinocytes as a double layer on meshed autogenous split-thickness skin grafts can hardly be advocated.

Competence evaluation processes for nursing students abroad: Findings from an international case study.

PubMed

Tommasini, Cristina; Dobrowolska, Beata; Zarzycka, Danuta; Bacatum, Claudia; Bruun, Anne Marie Gran; Korsath, Dag; Roel, Siv; Jansen, Mette Bro; Milling, Tine; Deschamps, Anne; Mantzoukas, Stefanos; Mantzouka, Christine; Palese, Alvisa

2017-04-01

Assessing clinical competence in nursing students abroad is a challenge, and requires both methods and instruments capable of capturing the multidimensional nature of the clinical competences acquired. The aim of the study was to compare the clinical competence assessment processes and instruments adopted for nursing students during their clinical placement abroad. A case study design was adopted in 2015. A purposeful sample of eight nursing programmes located in seven countries (Belgium, Denmark, Greece, Norway, Poland, Portugal and Italy) were approached. Tools as instruments for evaluating competences developed in clinical training by international nursing students, and written procedures aimed at guiding the evaluation process, were scrutinised through a content analysis method. All clinical competence evaluation procedures and instruments used in the nursing programmes involved were provided in English. A final evaluation of the competences was expected by all nursing programmes at the end of the clinical placement, while only four provided an intermediate evaluation. Great variability emerged in the tools, with between five and 88 items included. Through content analysis, 196 items emerged, classified into 12 different core competence categories, the majority were categorised as 'Technical skills' (=60), 'Self-learning and critical thinking' (=27) and 'Nursing care process' (=25) competences. Little emphasis was given in the tools to competences involving 'Self-adaptation', 'Inter-professional skills', 'Clinical documentation', 'Managing nursing care', 'Patient communication', and 'Theory and practice integration'. Institutions signing Bilateral Agreements should agree upon the competences expected from students during their clinical education abroad. The tools used in the process, as well as the role expected by the student, should also be agreed upon. Intercultural competences should be further addressed in the process of evaluation, in addition to adaptation to different settings. There is also a need to establish those competences achievable or not in the host country, aiming at increasing transparency in learning expectations and evaluation. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparative effectiveness of next generation genomic sequencing for disease diagnosis: design of a randomized controlled trial in patients with colorectal cancer/polyposis syndromes.

PubMed

Gallego, Carlos J; Bennette, Caroline S; Heagerty, Patrick; Comstock, Bryan; Horike-Pyne, Martha; Hisama, Fuki; Amendola, Laura M; Bennett, Robin L; Dorschner, Michael O; Tarczy-Hornoch, Peter; Grady, William M; Fullerton, S Malia; Trinidad, Susan B; Regier, Dean A; Nickerson, Deborah A; Burke, Wylie; Patrick, Donald L; Jarvik, Gail P; Veenstra, David L

2014-09-01

Whole exome and whole genome sequencing are applications of next generation sequencing transforming clinical care, but there is little evidence whether these tests improve patient outcomes or if they are cost effective compared to current standard of care. These gaps in knowledge can be addressed by comparative effectiveness and patient-centered outcomes research. We designed a randomized controlled trial that incorporates these research methods to evaluate whole exome sequencing compared to usual care in patients being evaluated for hereditary colorectal cancer and polyposis syndromes. Approximately 220 patients will be randomized and followed for 12 months after return of genomic findings. Patients will receive findings associated with colorectal cancer in a first return of results visit, and findings not associated with colorectal cancer (incidental findings) during a second return of results visit. The primary outcome is efficacy to detect mutations associated with these syndromes; secondary outcomes include psychosocial impact, cost-effectiveness and comparative costs. The secondary outcomes will be obtained via surveys before and after each return visit. The expected challenges in conducting this randomized controlled trial include the relatively low prevalence of genetic disease, difficult interpretation of some genetic variants, and uncertainty about which incidental findings should be returned to patients. The approaches utilized in this study may help guide other investigators in clinical genomics to identify useful outcome measures and strategies to address comparative effectiveness questions about the clinical implementation of genomic sequencing in clinical care. Copyright © 2014 Elsevier Inc. All rights reserved.

A Comparative Analysis of Health-Related Quality of Life and Family Impact between Children with ADHD Treated in a General Pediatric Clinic and a Psychiatric Clinic Utilizing the PedsQL

ERIC Educational Resources Information Center

Limbers, Christine A.; Ripperger-Suhler, Jane; Boutton, Kelly; Ransom, Daniel; Varni, James W.

2011-01-01

Objective: To evaluate health-related quality of life (HRQOL) from the perspective of children with ADHD and their parents being seen in a Pediatric Clinic in comparison to healthy children and children with ADHD being seen in a Psychiatric Clinic. Method: Participants were children with a physician diagnosis of ADHD ages 5-18 years and their…

Defining Surrogate Endpoints for Clinical Trials in Severe Falciparum Malaria

PubMed Central

Plewes, Katherine; Maude, Richard J.; Hanson, Josh; Herdman, M. Trent; Leopold, Stije J.; Ngernseng, Thatsanun; Charunwatthana, Prakaykaew; Phu, Nguyen Hoan; Ghose, Aniruddha; Hasan, M. Mahtab Uddin; Fanello, Caterina I.; Faiz, Md Abul; Hien, Tran Tinh; Day, Nicholas P. J.; White, Nicholas J.; Dondorp, Arjen M.

2017-01-01

Background Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. Methods Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African ‘AQUAMAT’ trial comparing artesunate and quinine (children), and the Vietnamese ‘AQ’ study (adults) comparing artemether with quinine. The absolute change, relative change, slope of the normalization over time, and time to normalization were derived from sequential measurements of plasma lactate and coma score, and validated for their use as surrogate endpoint, including the proportion of treatment effect on mortality explained (PTE) by these surrogate measures. Results Improvements in lactate concentration or coma scores over the first 24 hours of admission, were strongly prognostic for survival in all datasets. In hyperlactataemic patients in the AQ study (n = 173), lower mortality with artemether compared to quinine closely correlated with faster reduction in plasma lactate concentration, with a high PTE of the relative change in plasma lactate at 8 and 12 hours of 0.81 and 0.75, respectively. In paediatric patients enrolled in the ‘AQUAMAT’ study with cerebral malaria (n = 785), mortality was lower with artesunate compared to quinine, but this was not associated with faster coma recovery. Conclusions The relative changes in plasma lactate concentration assessed at 8 or 12 hours after admission are valid surrogate endpoints for severe malaria studies on antimalarial drugs or adjuvant treatments aiming at improving the microcirculation. Measures of coma recovery are not valid surrogate endpoints for mortality. PMID:28052109

Defining Surrogate Endpoints for Clinical Trials in Severe Falciparum Malaria.

PubMed

Jeeyapant, Atthanee; Kingston, Hugh W; Plewes, Katherine; Maude, Richard J; Hanson, Josh; Herdman, M Trent; Leopold, Stije J; Ngernseng, Thatsanun; Charunwatthana, Prakaykaew; Phu, Nguyen Hoan; Ghose, Aniruddha; Hasan, M Mahtab Uddin; Fanello, Caterina I; Faiz, Md Abul; Hien, Tran Tinh; Day, Nicholas P J; White, Nicholas J; Dondorp, Arjen M

2017-01-01

Clinical trials in severe falciparum malaria require a large sample size to detect clinically meaningful differences in mortality. This means few interventions can be evaluated at any time. Using a validated surrogate endpoint for mortality would provide a useful alternative allowing a smaller sample size. Here we evaluate changes in coma score and plasma lactate as surrogate endpoints for mortality in severe falciparum malaria. Three datasets of clinical studies in severe malaria were re-evaluated: studies from Chittagong, Bangladesh (adults), the African 'AQUAMAT' trial comparing artesunate and quinine (children), and the Vietnamese 'AQ' study (adults) comparing artemether with quinine. The absolute change, relative change, slope of the normalization over time, and time to normalization were derived from sequential measurements of plasma lactate and coma score, and validated for their use as surrogate endpoint, including the proportion of treatment effect on mortality explained (PTE) by these surrogate measures. Improvements in lactate concentration or coma scores over the first 24 hours of admission, were strongly prognostic for survival in all datasets. In hyperlactataemic patients in the AQ study (n = 173), lower mortality with artemether compared to quinine closely correlated with faster reduction in plasma lactate concentration, with a high PTE of the relative change in plasma lactate at 8 and 12 hours of 0.81 and 0.75, respectively. In paediatric patients enrolled in the 'AQUAMAT' study with cerebral malaria (n = 785), mortality was lower with artesunate compared to quinine, but this was not associated with faster coma recovery. The relative changes in plasma lactate concentration assessed at 8 or 12 hours after admission are valid surrogate endpoints for severe malaria studies on antimalarial drugs or adjuvant treatments aiming at improving the microcirculation. Measures of coma recovery are not valid surrogate endpoints for mortality.

Evaluation of the clinical usefulness of modulated arc treatment

NASA Astrophysics Data System (ADS)

Lee, Young Kyu; Jang, Hong Seok; Kim, Yeon Sil; Choi, Byung Ock; Kang, Young-Nam; Nam, Sang Hee; Park, Hyeong Wook; Kim, Shin Wook; Shin, Hun Joo; Lee, Jae Choon; Kim, Ji Na; Park, Sung Kwang; Kim, Jin Young

2015-07-01

The purpose of this study is to evaluate the clinical usefulness of modulated arc (mARC) treatment techniques. The mARC treatment plans for non-small-cell lung cancer (NSCLC) patients were made in order to verify the clinical usefulness of mARC. A pre-study was conducted to find the best plan condition for mARC treatment, and the usefulness of the mARC treatment plan was evaluated by comparing it with other Arc treatment plans such as tomotherapy and RapidArc plans. In the case of mARC, the optimal condition for the mARC plan was determined by comparing the dosimetric performance of the mARC plans developed by using various parameters, which included the photon energy (6 MV, 10 MV), the optimization point angle (6°- 10°intervals), and the total number of segments (36 - 59 segments). The best dosimetric performance of mARC was observed at a 10 MV photon energy, a point angle 6 degrees, and 59 segments. The treatment plans for the three different techniques were compared by using the following parameters: the conformity index (CI), homogeneity index (HI), the target coverage, the dose to the OARs, the number of monitor units (MU), the beam on time, and the normal tissue complication probability (NTCP). As a result, the three different treatment techniques showed similar target coverages. The mARC plan had the lowest V20 (volume of lung receiving > 20 Gy) and MU per fraction compared with both the RapidArc and the tomotherapy plans. The mARC plan reduced the beam on time as well. Therefore, the results of this study provide satisfactory evidence that the mARC technique can be considered as a useful clinical technique for radiation treatment.

Self-expandable metal stents for malignant esophageal obstruction: a comparative study between extrinsic and intrinsic compression.

PubMed

Rhee, K; Kim, J-H; Jung, D H; Han, J W; Lee, Y C; Lee, S K; Shin, S K; Park, J C; Chung, H S; Park, J J; Youn, Y H; Park, H

2016-04-01

Self-expandable metal stents (SEMSs) are effective for malignant esophageal obstruction, but usefulness of SEMSs in extrinsic lesions is yet to be elucidated. This study is aimed at evaluating the clinical usefulness of SEMSs in the extrinsic compression compared with intrinsic. A retrospective review was conducted for 105 patients (intrinsic, 85; extrinsic, 20) with malignant esophageal obstruction who underwent endoscopic SEMSs placement. Technical and clinical success rates were evaluated and clinical outcomes were compared between extrinsic and intrinsic group. Extrinsic group was mostly pulmonary origin. Overall technical and clinical success rate was 100% and 91%, respectively, without immediate complications. Extrinsic and intrinsic group did not differ significantly in clinical success rate. The median stent patency time was 131.3 ± 85.8 days in intrinsic group while that of extrinsic was 54.6 ± 45.1 due to shorter survival after stent insertion. The 4-, 8-, and 12-week patency rates were 90.5%, 78.8%, and 64.9% respectively in intrinsic group, while stents of extrinsic group remained patent until death. Uncovered, fully covered, and double-layered stent were used evenly and the types did not influence patency in both groups. In conclusion, esophageal SEMSs can safely and effectively be used for malignant extrinsic compression as well as intrinsic. © 2015 International Society for Diseases of the Esophagus.

Biopharmaceutical industry-sponsored global clinical trials in emerging countries.

PubMed

Alvarenga, Lenio Souza; Martins, Elisabeth Nogueira

2010-01-01

To evaluate biopharmaceutical industry-sponsored clinical trials placed in countries previously described as emerging regions for clinical research, and potential differences for those placed in Brazil. Data regarding recruitment of subjects for clinical trials were retrieved from www.clinicaltrials.gov on February 2nd 2009. Proportions of sites in each country were compared among emerging countries. Multiple logistic regressions were performed to evaluate whether trial placement in Brazil could be predicted by trial location in other countries and/or by trial features. A total of 8,501 trials were then active and 1,170 (13.8%) included sites in emerging countries (i.e., Argentina, Brazil, China, Czech Republic, Hungary, India, Mexico, Poland, Russia, South Korea, and South Africa). South Korea and China presented a significantly higher proportion of sites when compared to other countries (p<0.05). Multiple logistic regressions detected no negative correlation between placement in other countries when compared to Brazil. Trials involving subjects with less than 15 years of age, those with targeted recruitment of at least 1,000 subjects, and seven sponsors were identified as significant predictors of trial placement in Brazil. No clear direct competition between Brazil and other emerging countries was detected. South Korea showed the higher proportion of sites and ranked third in total number of trials, appearing as a major player in attractiveness for biopharmaceutical industry-sponsored clinical trials.

Microbiological and clinical effects of probiotics and antibiotics on nonsurgical treatment of chronic periodontitis: a randomized placebo- controlled trial with 9-month follow-up

PubMed Central

Morales, Alicia; Gandolfo, Alessandro; Bravo, Joel; Carvajal, Paola; Silva, Nora; Godoy, Claudia; Garcia-Sesnich, Jocelyn; Hoare, Anilei; Diaz, Patricia; Gamonal, Jorge

2018-01-01

ABSTRACT Objective The aim of this double-blind, placebo-controlled and parallel- arm randomized clinical trial was to evaluate the effects of Lactobacillus rhamnosus SP1-containing probiotic sachet and azithromycin tablets as an adjunct to nonsurgical therapy in clinical parameters and in presence and levels of Tannerella forsythia, Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans. Material and Methods Forty-seven systemically healthy volunteers with chronic periodontitis were recruited and monitored clinically and microbiologically at baseline for 3, 6 and 9 months after therapy. Subgingival plaque samples were collected from four periodontal sites with clinical attachment level ≥1 mm, probing pocket depth ≥4 mm and bleeding on probing, one site in each quadrant. Samples were cultivated and processed using the PCR technique. Patients received nonsurgical therapy including scaling and root planing (SRP) and were randomly assigned to a probiotic (n=16), antibiotic (n = 16) or placebo (n = 15) group. L. rhamnosus SP1 was taken once a day for 3 months. Azithromycin 500mg was taken once a day for 5 days. Results All groups showed improvements in clinical and microbiological parameters at all time points evaluated. Probiotic and antibiotic groups showed greater reductions in cultivable microbiota compared with baseline. The placebo group showed greater reduction in number of subjects with P. gingivalis compared with baseline. However, there were no significant differences between groups. Conclusions The adjunctive use of L. rhamnosus SP1 sachets and azithromycin during initial therapy resulted in similar clinical and microbiological improvements compared with the placebo group. PMID:29364340

Randomized clinical trial to evaluate the efficacy of a 5-day ceftiofur hydrochloride intramammary treatment on nonsevere gram-negative clinical mastitis.

PubMed

Schukken, Y H; Bennett, G J; Zurakowski, M J; Sharkey, H L; Rauch, B J; Thomas, M J; Ceglowski, B; Saltman, R L; Belomestnykh, N; Zadoks, R N

2011-12-01

The objective of this study was to evaluate the efficacy of intramammary treatment with ceftiofur hydrochloride of nonsevere, clinical coliform mastitis. One hundred four cases on 5 farms met the enrollment criteria for the study. Escherichia coli was the most common coliform species identified in milk samples from cows with mild to moderate clinical mastitis, followed by Klebsiella spp. and Enterobacter spp. At enrollment, a milk sample from the affected quarter was taken and used for on-farm culture or submitted to the laboratory. For cows in the treatment group, treatment was initiated with ceftiofur hydrochloride via intramammary infusion at 24-h intervals for 5 d according to label standards. Cows in the control group did not receive treatment. Culture results were available on the day after enrollment and only cows with coliform mastitis continued in the treatment and untreated control groups. Bacteriological cure was defined based on 2 posttreatment milk samples. Molecular typing was used for final definition of bacteriological cure. Treatment of nonsevere clinical gram-negative mastitis with ceftiofur hydrochloride resulted in a significant increase in bacteriological cure compared with nontreated controls in animals infected with E. coli or Klebsiella spp. Treated animals clinically improved significantly more compared with control cows. No significant differences were observed between treated and control animals in milk production or linear score before or after clinical mastitis. Treated animals left the study less frequently compared with control animals. Copyright © 2011 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Outcomes of a pharmacotherapy/research rotation in a family medicine training program.

PubMed

Murphy, Julie A; Shrader, Sarah R; Montooth, Audrey K

2008-06-01

The effects of a required pharmacotherapy/research rotation in family medicine residency programs, precepted by a clinical pharmacist, have not been documented in the literature. This study evaluated the effects that a focused pharmacotherapy/research rotation had on family medicine residents' knowledge of pharmacotherapy and research topics. During the first year of a family medicine residency, 15 residents were required to complete 1 month in pharmacotherapy and research. They spent time observing a pharmacist-run clinic and discussing pharmacotherapy and research topics. Residents completed a 20-question pretest and a posttest consisting of 15 pharmacotherapy and five research questions while on the rotation. Higher scores on the tests indicated higher levels of knowledge. The differences in mean scores were evaluated using paired t tests. Overall, the mean score on the pretest was 10.13 compared to 14.67 on the posttest. Mean scores on the pharmacotherapy and research components for the pretests and posttests were 7.27 compared to 10.47 and 2.87 compared to 4.20, respectively. A focused pharmacotherapy/research rotation, precepted by a clinical pharmacist, increases family medicine residents' knowledge.

A Comparative Analysis of Drug-Induced Hepatotoxicity in Clinically Relevant Situations

PubMed Central

Thiel, Christoph; Cordes, Henrik; Fabbri, Lorenzo; Aschmann, Hélène Eloise; Baier, Vanessa; Atkinson, Francis; Blank, Lars Mathias; Kuepfer, Lars

2017-01-01

Drug-induced toxicity is a significant problem in clinical care. A key problem here is a general understanding of the molecular mechanisms accompanying the transition from desired drug effects to adverse events following administration of either therapeutic or toxic doses, in particular within a patient context. Here, a comparative toxicity analysis was performed for fifteen hepatotoxic drugs by evaluating toxic changes reflecting the transition from therapeutic drug responses to toxic reactions at the cellular level. By use of physiologically-based pharmacokinetic modeling, in vitro toxicity data were first contextualized to quantitatively describe time-resolved drug responses within a patient context. Comparatively studying toxic changes across the considered hepatotoxicants allowed the identification of subsets of drugs sharing similar perturbations on key cellular processes, functional classes of genes, and individual genes. The identified subsets of drugs were next analyzed with regard to drug-related characteristics and their physicochemical properties. Toxic changes were finally evaluated to predict both molecular biomarkers and potential drug-drug interactions. The results may facilitate the early diagnosis of adverse drug events in clinical application. PMID:28151932

New generation cut-and-seal devices in oral and oropharyngeal cancer resection: clinical and cost-effectiveness study.

PubMed

Tirelli, G; Del Piero, G C; Valentinuz, G; Monte, A; Gatto, A; Rebelli, A; Quatela, E

2018-04-01

To evaluate the clinical efficacy and cost-effectiveness of ultrasonic shears and the electrothermal bipolar vessel sealing system, in comparison to the traditional cold knife and bipolar forceps, in oral and oropharyngeal cancer surgery. Patients who underwent oral or oropharyngeal cancer resection and neck dissection with either ultrasonic shears (n = 36) or electrothermal bipolar vessel sealing (n = 32) were enrolled. Surgical time, intra-operative bleeding, blood drainage, post-operative pain, neck oedema, complications and hospitalisation duration were compared to those of an historical cohort of 36 patients treated using a cold knife and bipolar forceps. Additionally, a cost-effectiveness evaluation was performed. Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, were advantageous compared to the traditional techniques. The cost of ultrasonic shears and electrothermal bipolar vessel sealing was completely offset by declining time-driven costs for the surgical team and operating theatre. Ultrasonic shears and, in particular, electrothermal bipolar vessel sealing, are more advantageous compared to the traditional techniques, from both a clinical and economic point of view.

Patient Navigation As a Model to Increase Participation of African Americans in Cancer Clinical Trials.

PubMed

Fouad, Mona N; Acemgil, Aras; Bae, Sejong; Forero, Andres; Lisovicz, Nedra; Martin, Michelle Y; Oates, Gabriela R; Partridge, Edward E; Vickers, Selwyn M

2016-06-01

Less than 10% of patients enrolled in clinical trials are minorities. The patient navigation model has been used to improve access to medical care but has not been evaluated as a tool to increase the participation of minorities in clinical trials. The Increasing Minority Participation in Clinical Trials project used patient navigators (PNs) to enhance the recruitment of African Americans for and their retention in therapeutic cancer clinical trials in a National Cancer Institute-designated comprehensive cancer center. Lay individuals were hired and trained to serve as PNs for clinical trials. African American patients potentially eligible for clinical trials were identified through chart review or referrals by clinic nurses, physicians, and social workers. PNs provided two levels of services: education about clinical trials and tailored support for patients who enrolled in clinical trials. Between 2007 and 2014, 424 African American patients with cancer were referred to the Increasing Minority Participation in Clinical Trials project. Of those eligible for a clinical trial (N = 378), 304 (80.4%) enrolled in a trial and 272 (72%) consented to receive patient navigation support. Of those receiving patient navigation support, 74.5% completed the trial, compared with 37.5% of those not receiving patient navigation support. The difference in retention rates between the two groups was statistically significant (P < .001). Participation of African Americans in therapeutic cancer clinical trials increased from 9% to 16%. Patient navigation for clinical trials successfully retained African Americans in therapeutic trials compared with non-patient navigation trial participation. The model holds promise as a strategy to reduce disparities in cancer clinical trial participation. Future studies should evaluate it with racial/ethnic minorities across cancer centers. Copyright © 2016 by American Society of Clinical Oncology.

COMPUTERIZED NEEDS-ORIENTED QUALITY MEASUREMENT EVALUATION SYSTEM (CONQUEST)

EPA Science Inventory

CONQUEST is an easy-to-use quality improvement software tool that uses a common structure and language to help users identity, understand, compare, evaluate, and select among 1,200 clinical performance measures that can be used to assess and improve quality of care. CONQUEST's in...

Performance evaluation of automated segmentation software on optical coherence tomography volume data

PubMed Central

Tian, Jing; Varga, Boglarka; Tatrai, Erika; Fanni, Palya; Somfai, Gabor Mark; Smiddy, William E.

2016-01-01

Over the past two decades a significant number of OCT segmentation approaches have been proposed in the literature. Each methodology has been conceived for and/or evaluated using specific datasets that do not reflect the complexities of the majority of widely available retinal features observed in clinical settings. In addition, there does not exist an appropriate OCT dataset with ground truth that reflects the realities of everyday retinal features observed in clinical settings. While the need for unbiased performance evaluation of automated segmentation algorithms is obvious, the validation process of segmentation algorithms have been usually performed by comparing with manual labelings from each study and there has been a lack of common ground truth. Therefore, a performance comparison of different algorithms using the same ground truth has never been performed. This paper reviews research-oriented tools for automated segmentation of the retinal tissue on OCT images. It also evaluates and compares the performance of these software tools with a common ground truth. PMID:27159849

Tear film aberration dynamics and vision-related quality of life in patients with dry eye disease.

PubMed

Denoyer, Alexandre; Rabut, Ghislaine; Baudouin, Christophe

2012-09-01

Corneal and ocular wavefront aberrations were recorded together with clinical examination results and patient-reported vision-related quality-of-life evaluation results to define the relevance of dynamic optical analysis of the eye in dry eye disease (DED). Prospective and comparative clinical study. Forty DED patients and 40 age- and gender-matched control subjects. Serial measurements of ocular and corneal higher-order aberrations (HOAs) after blink were performed for 10 seconds using the KR-1 aberrometer (Topcon, Clichy, France). Vision-related health-targeted quality of life was evaluated using the Ocular Surface Disease Index (OSDI) questionnaire. The clinical examination included tear film assessment (tear film break-up time and Schirmer I test), ocular surface damage assessment with the Oxford and van Bijsterveld indexes, and Meibomian dysfunction grading. Tear osmolarity also was measured. The time course of HOAs and modulation transfer function (MTF) was compared between groups and was analyzed in comparison with the OSDI and clinical data in DED patients. The root mean square of ocular and corneal total HOAs, particularly third-order aberrations, significantly increased over the 10-second period in DED patients, whereas no change occurred in controls. Analysis of MTF revealed progressive degradation of ocular optical quality resulting from loss of contrast at intermediate and high spatial frequencies in DED patients compared with controls. The progression index for corneal HOAs was correlated with the subjective index of patient-reported visual outcomes and with objective clinical findings of tear film and ocular surface damage. Objective measurement of the time course of HOAs may constitute a new single instrument to evaluate and manage patients with DED because it reliably reflects the completeness of the disease. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Clinical feasibility of simultaneous multi-slice imaging with blipped-CAIPI for diffusion-weighted imaging and diffusion-tensor imaging of the brain.

PubMed

Yokota, Hajime; Sakai, Koji; Tazoe, Jun; Goto, Mariko; Imai, Hiroshi; Teramukai, Satoshi; Yamada, Kei

2017-12-01

Background Simultaneous multi-slice (SMS) imaging is starting to be used in clinical situation, although evidence of clinical feasibility is scanty. Purpose To prospectively assess the clinical feasibility of SMS diffusion-weighted imaging (DWI) and diffusion-tensor imaging (DTI) with blipped-controlled aliasing in parallel imaging for brain lesions. Material and Methods The institutional review board approved this study. This study included 156 hyperintense lesions on DWI from 32 patients. A slice acceleration factor of 2 was applied for SMS scans, which allowed shortening of the scan time by 41.3%. The signal-to-noise ratio (SNR) was calculated for brain tissue of a selected slice. The contrast-to-noise ratio (CNR), apparent diffusion coefficient (ADC), and fractional anisotropy (FA) were calculated in 36 hyperintense lesions with a diameter of three pixels or more. Visual assessment was performed for all 156 lesions. Tractography of the corticospinal tract of 29 patients was evaluated. The number of tracts and averaged tract length were used for quantitative analysis, and visual assessment was evaluated by grading. Results The SMS scan showed no bias and acceptable 95% limits of agreement compared to conventional scans in SNR, CNR, and ADC on Bland-Altman analyses. Only FA of the lesions was higher in the SMS scan by 9% ( P = 0.016), whereas FA of the surrounding tissues was similar. Quantitative analysis of tractography showed similar values. Visual assessment of DWI hyperintense lesions and tractography also resulted in comparable evaluation. Conclusion SMS imaging was clinically feasible for imaging quality and quantitative values compared with conventional DWI and DTI.

High serum soluble tumor necrosis factor receptor 1 predicts poor treatment response in acute-stage schizophrenia.

PubMed

Nishimon, Shohei; Ohnuma, Tohru; Takebayashi, Yuto; Katsuta, Narimasa; Takeda, Mayu; Nakamura, Toru; Sannohe, Takahiro; Higashiyama, Ryoko; Kimoto, Ayako; Shibata, Nobuto; Gohda, Tomohito; Suzuki, Yusuke; Yamagishi, Sho-Ichi; Tomino, Yasuhiko; Arai, Heii

2017-06-02

Inflammation may be involved in the pathophysiology of schizophrenia. However, few cross-sectional or longitudinal studies have examined changes in biomarker expression to evaluate diagnostic and prognostic efficacy in acute-stage schizophrenia. We compared serum inflammatory biomarker concentrations in 87 patients with acute-stage schizophrenia on admission to 105 age-, sex-, and body mass index (BMI)-matched healthy controls. The measured biomarkers were soluble tumor necrosis factor receptor 1 (sTNFR1) and adiponectin, which are associated with inflammatory responses, and pigment epithelium-derived factor (PEDF), which has anti-inflammatory properties. We then investigated biomarker concentrations and associations with clinical factors in 213 patients (including 42 medication-free patients) and 110 unmatched healthy controls to model conditions typical of clinical practice. Clinical symptoms were assessed using the Brief Psychiatric Rating Scale and Global Assessment of Function. In 121 patients, biomarker levels and clinical status were evaluated at both admission and discharge. Serum sTNFR1 was significantly higher in patients with acute-stage schizophrenia compared to matched controls while no significant group differences were observed for the other markers. Serum sTNFR1 was also significantly higher in the 213 patients compared to unmatched controls. The 42 unmedicated patients had significantly lower PEDF levels compared to controls. Between admission and discharge, sTNFR1 levels decreased significantly; however, biomarker changes did not correlate with clinical symptoms. The discriminant accuracy of sTNFR1 was 93.2% between controls and patients, showing no symptom improvement during care. Inflammation and a low-level anti-inflammatory state may be involved in both schizophrenia pathogenesis and acute-stage onset. High serum sTNFR1 in the acute stage could be a useful prognostic biomarker for treatment response in clinical practice. Copyright © 2017 Elsevier Inc. All rights reserved.

Dehydration and performance on clinical concussion measures in collegiate wrestlers.

PubMed

Weber, Amanda Friedline; Mihalik, Jason P; Register-Mihalik, Johna K; Mays, Sally; Prentice, William E; Guskiewicz, Kevin M

2013-01-01

The effects of dehydration induced by wrestling-related weight-cutting tactics on clinical concussion outcomes, such as neurocognitive function, balance performance, and symptoms, have not been adequately studied. To evaluate the effects of dehydration on the outcome of clinical concussion measures in National Collegiate Athletic Association Division I collegiate wrestlers. Repeated-measures design. Clinical research laboratory. Thirty-two Division I healthy collegiate male wrestlers (age = 20.0 ± 1.4 years; height = 175.0 ± 7.5 cm; baseline mass = 79.2 ± 12.6 kg). Participants completed preseason concussion baseline testing in early September. Weight and urine samples were also collected at this time. All participants reported to prewrestling practice and postwrestling practice for the same test battery and protocol in mid-October. They had begun practicing weight-cutting tactics a day before prepractice and postpractice testing. Differences between these measures permitted us to evaluate how dehydration and weight-cutting tactics affected concussion measures. Sport Concussion Assessment Tool 2 (SCAT2), Balance Error Scoring System, Graded Symptom Checklist, and Simple Reaction Time scores. The Simple Reaction Time was measured using the Automated Neuropsychological Assessment Metrics. The SCAT2 measurements were lower at prepractice (P = .002) and postpractice (P < .001) when compared with baseline. The BESS error scores were higher at postpractice when compared with baseline (P = .015). The GSC severity scores were higher at prepractice (P = .011) and postpractice (P < .001) than at baseline and at postpractice when than at prepractice (P = .003). The number of Graded Symptom Checklist symptoms reported was also higher at prepractice (P = .036) and postpractice (P < .001) when compared with baseline, and at postpractice when compared with prepractice (P = .003). Our results suggest that it is important for wrestlers to be evaluated in a euhydrated state to ensure that dehydration is not influencing the outcome of the clinical measures.

Dehydration and Performance on Clinical Concussion Measures in Collegiate Wrestlers

PubMed Central

Weber, Amanda Friedline; Mihalik, Jason P.; Register-Mihalik, Johna K.; Mays, Sally; Prentice, William E.; Guskiewicz, Kevin M.

2013-01-01

Context: The effects of dehydration induced by wrestling-related weight-cutting tactics on clinical concussion outcomes, such as neurocognitive function, balance performance, and symptoms, have not been adequately studied. Objective: To evaluate the effects of dehydration on the outcome of clinical concussion measures in National Collegiate Athletic Association Division I collegiate wrestlers. Design: Repeated-measures design. Setting: Clinical research laboratory. Patients or Other Participants: Thirty-two Division I healthy collegiate male wrestlers (age = 20.0 ± 1.4 years; height = 175.0 ± 7.5 cm; baseline mass = 79.2 ± 12.6 kg). Intervention(s): Participants completed preseason concussion baseline testing in early September. Weight and urine samples were also collected at this time. All participants reported to prewrestling practice and postwrestling practice for the same test battery and protocol in mid-October. They had begun practicing weight-cutting tactics a day before prepractice and postpractice testing. Differences between these measures permitted us to evaluate how dehydration and weight-cutting tactics affected concussion measures. Main Outcome Measures: Sport Concussion Assessment Tool 2 (SCAT2), Balance Error Scoring System, Graded Symptom Checklist, and Simple Reaction Time scores. The Simple Reaction Time was measured using the Automated Neuropsychological Assessment Metrics. Results: The SCAT2 measurements were lower at prepractice (P = .002) and postpractice (P < .001) when compared with baseline. The BESS error scores were higher at postpractice when compared with baseline (P = .015). The GSC severity scores were higher at prepractice (P = .011) and postpractice (P < .001) than at baseline and at postpractice when than at prepractice (P = .003). The number of Graded Symptom Checklist symptoms reported was also higher at prepractice (P = .036) and postpractice (P < .001) when compared with baseline, and at postpractice when compared with prepractice (P = .003). Conclusions: Our results suggest that it is important for wrestlers to be evaluated in a euhydrated state to ensure that dehydration is not influencing the outcome of the clinical measures. PMID:23672379

[Evaluation on methodological problems in reports concerning quantitative analysis of syndrome differentiation of diabetes mellitus].

PubMed

Chen, Bi-Cang; Wu, Qiu-Ying; Xiang, Cheng-Bin; Zhou, Yi; Guo, Ling-Xiang; Zhao, Neng-Jiang; Yang, Shu-Yu

2006-01-01

To evaluate the quality of reports published in recent 10 years in China about quantitative analysis of syndrome differentiation for diabetes mellitus (DM) in order to explore the methodological problems in these reports and find possible solutions. The main medical literature databases in China were searched. Thirty-one articles were included and evaluated by the principles of clinical epidemiology. There were many mistakes and deficiencies in these articles, such as clinical trial designs, diagnosis criteria for DM, standards of syndrome differentiation of DM, case inclusive and exclusive criteria, sample size and estimation, data comparability and statistical methods. It is necessary and important to improve the quality of reports concerning quantitative analysis of syndrome differentiation of DM in light of the principles of clinical epidemiology.

Evaluation and justification of clinical pharmacy services.

PubMed

Anderson, Scott V; Schumock, Glen T

2009-12-01

Pharmacy managers often must justify clinical pharmacy services (CPSs). This can be done by generalizing evidence from the literature or by conducting local evaluations. In either case, it is important that the clinical, humanistic or economic benefits of CPSs are considered, and limitations of the studies recognized. The basic model for the evaluation of CPSs includes the consideration of costs and outcomes, as well as the inclusion of a comparator group. Recent systematic reviews and individual studies provide good evidence regarding the value of CPSs, and are discussed here. Benefit-to-cost ratios of selected CPSs are also provided. While much of the evidence for CPSs has been conducted in the hospital setting, in the future, CPS expansion will occur in ambulatory care settings and will be benefited by healthcare reform efforts.

Comparative Evaluation of the Antimicrobial Efficacy of Three Immersion Chemical Disinfectants on Clinically Derived Poly(Vinyl Siloxane) Impressions.

PubMed

Jeyapalan, Vidhya; Krishnan, Chitra Shankar; Ramasubramanian, Hariharan; Sampathkumar, Jayakrishnakumar; Azhagarasan, N S; Krishnan, Madhusudan

2016-07-06

To comparatively evaluate the antimicrobial efficacy of freshly prepared electrolyzed oxidizing water (EOW) with that of 2.4% glutaraldehyde (GA) and 1% sodium hypochlorite (SH) on clinically derived poly vinyl siloxane (PVS) impressions. Four clinically derived PVS impressions each were obtained from 10 subjects. One impression from each subject was randomly kept as control (group I), without disinfection. The remaining three impressions were randomly disinfected by immersion in either 2.4% GA (group II), 1% SH (group III), or freshly prepared EOW (group IV). The samples were subjected to microbial culture individually on brain heart infusion (BHI) agar medium. The organisms isolated were confirmed by visual examination and gram staining. Mean colony forming units (CFU) were counted, log 10 reduction obtained and compared. Data were statistically analyzed using one-way ANOVA, followed by multiple comparisons using Tukey-HSD post hoc tests (p < 0.05). Streptococci, Staphylococci, Pseudomonas, Candida, Proteus, Klebsiella, and E. coli were isolated from all impressions including the controls, except those disinfected by EOW. All three disinfectants showed significant reduction in CFU and log 10 reduction values as compared to the controls. EOW showed significantly higher reduction in log 10 values compared to GA and SH, whereas GA and SH showed similar reductions. EOW, GA, and SH showed kill rates of 100%, 99.60%, and 99.82%, respectively. EOW showed significant antimicrobial efficacy as evidenced by reduction in log 10 values when used as an immersion disinfectant for PVS impressions when compared with the results obtained using GA and SH. These results need further investigation. EOW shows high antimicrobial efficacy when used as an immersion disinfectant as compared to GA and SH for clinically derived PVS impressions. © 2016 by the American College of Prosthodontists.

Evaluating the decision accuracy and speed of clinical data visualizations.

PubMed

Pieczkiewicz, David S; Finkelstein, Stanley M

2010-01-01

Clinicians face an increasing volume of biomedical data. Assessing the efficacy of systems that enable accurate and timely clinical decision making merits corresponding attention. This paper discusses the multiple-reader multiple-case (MRMC) experimental design and linear mixed models as means of assessing and comparing decision accuracy and latency (time) for decision tasks in which clinician readers must interpret visual displays of data. These tools can assess and compare decision accuracy and latency (time). These experimental and statistical techniques, used extensively in radiology imaging studies, offer a number of practical and analytic advantages over more traditional quantitative methods such as percent-correct measurements and ANOVAs, and are recommended for their statistical efficiency and generalizability. An example analysis using readily available, free, and commercial statistical software is provided as an appendix. While these techniques are not appropriate for all evaluation questions, they can provide a valuable addition to the evaluative toolkit of medical informatics research.

Live and Web-based orientations are comparable for a required rotation.

PubMed

Prunuske, Jacob

2010-03-01

Studies show equivalency in knowledge when measured following Web-based learning and live lecture. However, the effectiveness of a Web-based orientation for a required clinical rotation is unknown. Medical students viewed a Web-based orientation and completed a 13-item evaluation before beginning a required 6-week community medicine rotation. Evaluation data from 2007-2008 live orientation sessions were compared to responses from 2008-2009 Web-based orientation sessions. Data were analyzed by two-sample tests of proportion. A total of 169 students completed surveys during the study period--78 following the live and 91 following the Web-based orientation. Response rates were equal in the two groups. The survey tool had a high level of reliability (Cronbach's alpha=0.96). There was no statistical difference in student evaluations for 12 of 13 orientation evaluation items. Live and Web-based formats are comparable for presenting orientation materials to a required clinical rotation. Students felt the purpose of the rotation, educational goals, course structure, and requirements were clearly presented regardless of format. Transition from a live to Web-based format reduced faculty time required to present at rotation orientations.

Resident evaluation of clinical teachers based on teachers' certification.

PubMed

Steiner, Ivan P; Yoon, Philip W; Kelly, Karen D; Diner, Barry M; Donoff, Michel G; Mackey, Duncan S; Rowe, Brian H

2003-07-01

To examine the influence of emergency medicine (EM) certification of clinical teaching faculty on evaluations provided by residents. A prospective cohort analysis was conducted of assessments between July 1994 and July 2000 on residents' evaluations of EM faculty at the University of Alberta, Edmonton, Canada. Resident- and faculty-related variables were entered anonymously using the validated evaluation tool (ER Scale). Credentialing and demographic information on EM faculty was supplemented by data obtained through a nine-question survey. Groups were compared using ANOVA. The 562 residents returned 705 (91%) valid evaluation sheets on 115 EM faculty members. The four domains of didactic teaching, clinical teaching, approachability, and helpfulness were assessed. The majority of ratings were in the very good or superb categories for each domain. Instructors with certification in EM had higher scores in didactic, clinical teaching compared with others, and teachers without national certification scored lower in the helpful and approachable categories (p < 0.05). The route of obtaining EM certifications either through training or practice eligibility did not affect scores. Instructors under the age of 40 years had higher scores than the older age groups in three of four categories (p < 0.05). Instructors working at the teaching sites on a half-time basis received higher scores than those working full-time, and scores varied based on site. Overall, teaching ratings improved over the study period (p < 0.05). Significant differences exist among instructors in the EM setting that affect their teaching rating scores. National certification in EM, academic track, rotation year, and site are all correlated with better teaching performance.

The relationship between faculty performance assessment and results on the in-training examination for residents in an emergency medicine training program.

PubMed

Ryan, James G; Barlas, David; Pollack, Simcha

2013-12-01

Medical knowledge (MK) in residents is commonly assessed by the in-training examination (ITE) and faculty evaluations of resident performance. We assessed the reliability of clinical evaluations of residents by faculty and the relationship between faculty assessments of resident performance and ITE scores. We conducted a cross-sectional, observational study at an academic emergency department with a postgraduate year (PGY)-1 to PGY-3 emergency medicine residency program, comparing summative, quarterly, faculty evaluation data for MK and overall clinical competency (OC) with annual ITE scores, accounting for PGY level. We also assessed the reliability of faculty evaluations using a random effects, intraclass correlation analysis. We analyzed data for 59 emergency medicine residents during a 6-year period. Faculty evaluations of MK and OC were highly reliable (κ  =  0.99) and remained reliable after stratification by year of training (mean κ  =  0.68-0.84). Assessments of resident performance (MK and OC) and the ITE increased with PGY level. The MK and OC results had high correlations with PGY level, and ITE scores correlated moderately with PGY. The OC and MK results had a moderate correlation with ITE score. When residents were grouped by PGY level, there was no significant correlation between MK as assessed by the faculty and the ITE score. Resident clinical performance and ITE scores both increase with resident PGY level, but ITE scores do not predict resident clinical performance compared with peers at their PGY level.

The Relationship Between Faculty Performance Assessment and Results on the In-Training Examination for Residents in an Emergency Medicine Training Program

PubMed Central

Ryan, James G.; Barlas, David; Pollack, Simcha

2013-01-01

Background Medical knowledge (MK) in residents is commonly assessed by the in-training examination (ITE) and faculty evaluations of resident performance. Objective We assessed the reliability of clinical evaluations of residents by faculty and the relationship between faculty assessments of resident performance and ITE scores. Methods We conducted a cross-sectional, observational study at an academic emergency department with a postgraduate year (PGY)-1 to PGY-3 emergency medicine residency program, comparing summative, quarterly, faculty evaluation data for MK and overall clinical competency (OC) with annual ITE scores, accounting for PGY level. We also assessed the reliability of faculty evaluations using a random effects, intraclass correlation analysis. Results We analyzed data for 59 emergency medicine residents during a 6-year period. Faculty evaluations of MK and OC were highly reliable (κ  =  0.99) and remained reliable after stratification by year of training (mean κ  =  0.68–0.84). Assessments of resident performance (MK and OC) and the ITE increased with PGY level. The MK and OC results had high correlations with PGY level, and ITE scores correlated moderately with PGY. The OC and MK results had a moderate correlation with ITE score. When residents were grouped by PGY level, there was no significant correlation between MK as assessed by the faculty and the ITE score. Conclusions Resident clinical performance and ITE scores both increase with resident PGY level, but ITE scores do not predict resident clinical performance compared with peers at their PGY level. PMID:24455005

An acute stroke evaluation app: a practice improvement project.

PubMed

Rubin, Mark N; Fugate, Jennifer E; Barrett, Kevin M; Rabinstein, Alejandro A; Flemming, Kelly D

2015-04-01

A point-of-care workflow checklist in the form of an iOS (iPhone Operating System) app for use by stroke providers was introduced with the objective of standardizing acute stroke evaluation and documentation at 2 affiliated academic medical centers. Providers used the app in unselected, consecutive patients undergoing acute stroke evaluation in an emergency department or hospital setting between August 2012 and January 2013 and August 2013 and February 2014. Satisfaction surveys were prospectively collected pre- and postintervention from residents, staff neurologists, and clinical data specialists. Residents (20 preintervention and 16 postintervention), staff neurologists (6 pre and 5 post), and clinical data specialists (4 pre and 4 post) participated in this study. All 16 (100%) residents had increased satisfaction with their ability to perform an acute stroke evaluation postintervention but only 9 (56%) of 16 felt the app was more help than hindrance. Historical controls aligned with preintervention results. Staff neurologists conveyed increased satisfaction with resident presentations and decision making when compared to preintervention surveys. Stroke clinical data specialists estimated a 50% decrease in data abstraction when the app data were used in the clinical note. Concomitant effect on door-to-needle (DTN) time at 1 site, although not a primary study measure, was also evaluated. At that 1 center, the mean DTN time decreased by 16 minutes when compared to the corresponding months from the year prior. The point-of-care acute stroke workflow checklist app may assist trainees in presenting findings in a standardized manner and reduce data abstraction time. The app may help reduce DTN time, but this requires further study.

Analytical characterization and clinical evaluation of an enzyme-linked immunosorbent assay for measurement of afamin in human plasma.

PubMed

Dieplinger, Benjamin; Egger, Margot; Gabriel, Christian; Poelz, Werner; Morandell, Elisabeth; Seeber, Beata; Kronenberg, Florian; Haltmayer, Meinhard; Mueller, Thomas; Dieplinger, Hans

2013-10-21

Comparative proteomics has recently identified afamin, the newest member of the albumin gene family, as a potential biomarker for ovarian cancer. The aim of this study was the analytical and clinical evaluation of a sandwich enzyme-linked immunosorbent assay for the determination of afamin in human plasma. We evaluated precision, linearity, and detection limit of the assay, analyte stability and biological variability, determined reference values and quantified afamin concentrations in various diseases. Within-run and total coefficients of variation were <10%. The method was linear across the tested measurement range. Detection limit was 7 mg/L for the assay. The analyte was stable for 24 h at room temperature, for 48 h at 4°C, and for at least one year at -20°C and -80°C. The reference change value for healthy individuals was 24%. Age- and sex-independent reference values in healthy blood donors were 45-99 mg/L (median 68 mg/L). In the clinical assay evaluation afamin plasma concentrations were modestly decreased in patients with heart failure. Patients with pneumonia or sepsis exhibited markedly decreased afamin plasma concentrations. However, patients with chronic renal disease or chronic obstructive pulmonary disease showed no difference in afamin plasma concentrations as compared to healthy individuals. Correlation analyses revealed an inverse association between afamin and inflammatory biomarkers. The afamin assay meets quality specifications for laboratory medicine. The results of the clinical assay evaluation revealed novel insights with respect to afamin as a potential negative acute phase protein and should encourage further studies. © 2013.

Clinical trial resources on the internet must be designed to reach underrepresented minorities.

PubMed

Wilson, John J; Mick, Rosemarie; Wei, S Jack; Rustgi, Anil K; Markowitz, Sanford D; Hampshire, Maggie; Metz, James M

2006-01-01

Internet-based clinical trial information services are being developed to increase recruitment to studies. However, there are limited data that evaluate their ability to reach elderly and underrepresented minority populations. This study was designed to evaluate the ability of an established clinical trials registry to reach these populations based on expected Internet use. This study compares general Internet users to participants who enrolled in an Internet based colorectal cancer clinical trials registry established by OncoLink (www.oncolink.org) and the National Colorectal Cancer Research Alliance. Observed rates of demographic groupings were compared to those established for general Internet users. Two thousand, four hundred and thirty-seven participants from the continental United States used the Internet to register for the database. New England, the Mid-Atlantic region, and the Southeast had the highest relative frequency of participation in the database, whereas the Upper Midwest, California, and the South had the lowest rates. Compared to general Internet users, there was an overrepresentation of women (73% vs. 50%) and participants over 55 years old (27% vs. 14%). However, there was an underrepresentation of minorities (10.3% vs. 22%), particularly African Americans (3.1% vs. 8%) and Hispanics (2.8% vs. 9%). The Internet is a growing medium for registry into clinical trials databases. However, even taking into account the selection bias of Internet accessibility, there are still widely disparate demographics between general Internet users and those registering for clinical trials, particularly the underrepresentation of minorities. Internet-based educational and recruitment services for clinical trials must be designed to reach these underrepresented minorities to avoid selection biases in future clinical trials.

Clinical evaluation of the Jay Sensitivity Sensor Probe: a new microprocessor-controlled instrument to evaluate dentin hypersensitivity.

PubMed

Sowinski, Joseph A; Kakar, Ashish; Kakar, Kanupriya

2013-05-01

To compare the Jay Sensitivity Sensor Probe (Jay Probe), a new microprocessor-based, pre-calibrated instrument, with well accepted methods used to evaluate sensitivity, i.e. tactile response to the Yeaple Probe, air blast (Schiff scale), and patient responses by Visual Analog Score (VAS). Jay Probe assessments were accomplished using several approaches. With a cohort of 12 subjects, two clinical examiners compared the repeatability of the Jay and Yeaple Probes. A second evaluation of both probes was conducted during two independent parallel design clinical studies each enrolling 100 adults with dentin hypersensitivity (DH). In each study, subjects were evaluated for DH responses after twice daily oral hygiene with a negative control fluoride dentifrice or a positive control dentifrice formulated with ingredients proven to reduce sensitivity, i.e. potassium nitrate or 8.0% arginine with calcium carbonate. Tactile evaluations by the Jay and Yeaple Probes were conducted at baseline and recall visits over the 8-week duration of each study. Also evaluated at each visit were responses to air blast and to patient reported DH assessment by VAS. Low inter-examiner variability with no significant differences between replicate measurements (P > 0.05) was observed with the Jay Probe. Consistent with results from previous studies, subjects assigned dentifrices formulated with potassium nitrate or 8% arginine/calcium carbonate demonstrated improvements in Yeaple, air blast and VAS responses in comparison to those assigned the fluoride dentifrice (P < 0.05). Jay Probe responses correlated significantly with all other sensitivity measures (P < 0.05). Differences between these treatments were observed at all post-treatment evaluations using these methods.

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.

p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women

PubMed Central

Fetterman, Barbara; Castle, Philip E.; Schiffman, Mark; Wood, Shannon N.; Stiemerling, Eric; Tokugawa, Diane; Bodelon, Clara; Poitras, Nancy; Lorey, Thomas; Kinney, Walter

2015-01-01

Background: Human papillomavirus (HPV)–based cervical cancer screening requires triage markers to decide who should be referred to colposcopy. p16/Ki-67 dual stain cytology has been proposed as a biomarker for cervical precancers. We evaluated the dual stain in a large population of HPV-positive women. Methods: One thousand five hundred and nine HPV-positive women screened with HPV/cytology cotesting at Kaiser Permanente California were enrolled into a prospective observational study in 2012. Dual stain cytology was performed on residual Surepath material, and slides were evaluated for dual stain–positive cells. Disease endpoints were ascertained from the clinical database at KPNC. We evaluated the clinical performance of the assay among all HPV-positive women and among HPV-positive, cytology-negative women. We used internal benchmarks for clinical management to evaluate the clinical relevance of the dual stain assay. We evaluated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the dual stain compared with Pap cytology. All statistical tests were two-sided. Results: The dual stain had lower positivity (45.9%) compared with cytology at an ASC-US threshold (53.4%). For detection of CIN2+, the dual stain had similar sensitivity (83.4% vs 76.6%, P = .1), and statistically higher specificity (58.9% vs 49.6%, P < .001), PPV (21.0% vs 16.6%, P < .001), and NPV (96.4% vs 94.2%, P = .01) compared with cytology. Similar patterns were observed for CIN3+. Women with a positive test had high enough risk for referral to colposcopy, while the risk for women with negative tests was below a one-year return threshold based on current US management guidelines. Conclusion: Dual stain cytology showed good risk stratification for all HPV-positive women and for HPV-positive women with normal cytology. Additional follow-up is needed to determine how long dual stain negative women remain at low risk of precancer. PMID:26376685

Accelerant-related burns and drug abuse: Challenging combination.

PubMed

Leung, Leslie T F; Papp, Anthony

2018-05-01

Accelerants are flammable substances that may cause explosion when added to existing fires. The relationships between drug abuse and accelerant-related burns are not well elucidated in the literature. Of these burns, a portion is related to drug manufacturing, which have been shown to be associated with increased burn complications. 1) To evaluate the demographics and clinical outcomes of accelerant-related burns in a Provincial Burn Centre. 2) To compare the clinical outcomes with a control group of non-accelerant related burns. 3) To analyze a subgroup of patients with history of drug abuse and drug manufacturing. Retrospective case control study. Patient data associated with accelerant-related burns from 2009 to 2014 were obtained from the British Columbia Burn Registry. These patients were compared with a control group of non-accelerant related burns. Clinical outcomes that were evaluated include inhalational injury, ICU length of stay, ventilator support, surgeries needed, and burn complications. Chi-square test was used to evaluate categorical data and Student's t-test was used to evaluate mean quantitative data with the p value set at 0.05. A logistic regression model was used to evaluate factors affecting burn complications. Accelerant-related burns represented 28.2% of all burn admissions (N=532) from 2009 to 2014. The accelerant group had higher percentage of patients with history of drug abuse and was associated with higher TBSA burns, ventilator support, ICU stay and pneumonia rates compared to the non-accelerant group. Within the accelerant group, there was no difference in clinical outcomes amongst people with or without history of drug abuse. Four cases were associated with methamphetamine manufacturing, all of which underwent ICU stay and ventilator support. Accelerant-related burns cause significant burden to the burn center. A significant proportion of these patients have history of drug abuse. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Publications in anesthesia journals: quality and clinical relevance.

PubMed

Lauritsen, Jakob; Moller, Ann M

2004-11-01

Clinicians performing evidence-based anesthesia rely on anesthesia journals for clinically relevant information. The objective of this study was to analyze the proportion of clinically relevant articles in five high impact anesthesia journals. We evaluated all articles published in Anesthesiology, Anesthesia & Analgesia, British Journal of Anesthesia, Anesthesia, and Acta Anaesthesiologica Scandinavica from January to June, 2000. Articles were assessed and classified according to type, outcome, and design; 1379 articles consisting of 5468 pages were evaluated and categorized. The most common types of article were animal and laboratory research (31.2%) and randomized clinical trial (20.4%). A clinically relevant article was defined as an article that used a statistically valid method and had a clinically relevant end-point. Altogether 18.6% of the pages had as their subject matter clinically relevant trials. We compared the Journal Impact Factor (a measure of the number of citations per article in a journal) and the proportion of clinically relevant pages and found that they were inversely proportional to each other.

Implementations of clinical functional magnetic resonance imaging using character-based paradigms for the prediction of Chinese language dominance.

PubMed

Liu, Ho-Ling; Wu, Chien-Te; Chen, Jian-Chuan; Hsu, Yuan-Yu; Wai, Yau-Yau; Wan, Yung-Liang

2003-01-01

Recently, functional MRI (fMRI) using word generation (WG) tasks has been shown to be effective for mapping the Chinese language-related brain areas. In clinical applications, however, patients' performance cannot be easily monitored during WG tasks. In this study, we evaluated the feasibility of a word choice (WC) paradigm in the clinical setting and compared the results with those from WG tasks. Intrasubject comparisons of fMRI with both WG and WC paradigms were performed on six normal human subjects and two tumor patients. Subject responses in the WC paradigm, based on semantic judgments, were recorded. Activation strength, extent, and laterality were evaluated and compared. Our results showed that fMRI with the WC paradigm evoked weaker neuronal activation than that with the WG paradigm in Chinese language-related brain areas. It was sufficient to reveal language laterality for clinical use, however. In addition, it resulted in less nonlanguage-specific brain activation. Results from the patient data demonstrated strong evidence for the necessity of incorporating response monitoring during fMRI studies, which suggested that fMRI with the WC paradigm is more appropriate to be implemented for the prediction of Chinese language dominance in clinical environments.

Comparative evaluation of fluorescent in situ hybridization and Giemsa microscopy with quantitative real-time PCR technique in detecting malaria parasites in a holoendemic region of Kenya.

PubMed

Osoga, Joseph; Waitumbi, John; Guyah, Bernard; Sande, James; Arima, Cornel; Ayaya, Michael; Moseti, Caroline; Morang'a, Collins; Wahome, Martin; Achilla, Rachel; Awinda, George; Nyakoe, Nancy; Wanja, Elizabeth

2017-07-24

Early and accurate diagnosis of malaria is important in treatment as well as in the clinical evaluation of drugs and vaccines. Evaluation of Giemsa-stained smears remains the gold standard for malaria diagnosis, although diagnostic errors and potential bias estimates of protective efficacy have been reported in practice. Plasmodium genus fluorescent in situ hybridization (P-Genus FISH) is a microscopy-based method that uses fluorescent labelled oligonucleotide probes targeted to pathogen specific ribosomal RNA fragments to detect malaria parasites in whole blood. This study sought to evaluate the diagnostic performance of P-Genus FISH alongside Giemsa microscopy compared to quantitative reverse transcription polymerase chain reaction (qRT-PCR) in a clinical setting. Five hundred study participants were recruited prospectively and screened for Plasmodium parasites by P-Genus FISH assay, and Giemsa microscopy. The microscopic methods were performed by two trained personnel and were blinded, and if the results were discordant a third reading was performed as a tie breaker. The diagnostic performance of both methods was evaluated against qRT-PCR as a more sensitive method. The number of Plasmodium positive cases was 26.8% by P-Genus FISH, 33.2% by Giemsa microscopy, and 51.2% by qRT-PCR. The three methods had 46.8% concordant results with 61 positive cases and 173 negative cases. Compared to qRT-PCR the sensitivity and specificity of P-Genus FISH assay was 29.3 and 75.8%, respectively, while microscopy had 58.2 and 93.0% respectively. Microscopy had a higher positive and negative predictive values (89.8 and 68.0% respectively) compared to P-Genus FISH (56.0 and 50.5%). In overall, microscopy had a good measure of agreement (76%, k = 0.51) compared to P-Genus FISH (52%, k = 0.05). The diagnostic performance of P-Genus FISH was shown to be inferior to Giemsa microscopy in the clinical samples. This hinders the possible application of the method in the field despite the many advantages of the method especially diagnosis of low parasite density infections. The P-Genus assay has great potential but application of the method in clinical setting would rely on extensive training of microscopist and continuous proficiency testing.

Magnetic resonance imaging in the evaluation of clinical treatment of otospongiosis: a pilot study.

PubMed

de Oliveira Vicente, Andy; Chandrasekhar, Sujana S; Yamashita, Helio K; Cruz, Oswaldo Laercio M; Barros, Flavia A; Penido, Norma O

2015-06-01

To evaluate the applicability of magnetic resonance imaging (MRI) as a method for monitoring the activity of otospongiotic lesions before and after clinical treatment. Prospective, randomized, controlled, double-blind study. One single tertiary care institution in a large, cosmopolitan city. Twenty-six patients (n = 42 ears) with clinical, audiometric, and tomographic diagnosis of otosclerosis were enrolled. If computed tomography (CT) demonstrated active lesions, these patients underwent MRI to detect otospongiotic foci, seen as areas of gadolinium enhancement. Patients were divided into 3 groups and received treatment with placebo, sodium alendronate, or sodium fluoride for 6 months. After this period, clinical and audiometric evaluations and a second MRI were performed. Each MRI was evaluated by both a neuroradiologist and an otolaryngologist in a subjective (visual) and objective (using specific eFilm Workstation software) manner. Otospongiosis was most predominantly identified in the region anterior to the oval window, and this site was reliable for comparing pre- and posttreatment scans. The patients in the alendronate and sodium fluoride groups had MRI findings that suggested a decrease in activity of otospongiotic lesions, more relevant in the alendronate group. These findings were statistically significant for both subjective and objective MRI evaluations. MRI shows higher sensitivity than clinical or audiometric assessment for detecting reduction in activity of otospongiosis. The objective MRI evaluation based on software analysis was the most accurate method of monitoring clinical treatment response in otospongiosis. © American Academy of Otolaryngology—Head and Neck Surgery Foundation 2015.

A framework for evaluating the appropriateness of clinical decision support alerts and responses

PubMed Central

Waitman, Lemuel R; Lewis, Julia B; Wright, Julie A; Choma, David P; Miller, Randolph A; Peterson, Josh F

2011-01-01

Objective Alerting systems, a type of clinical decision support, are increasingly prevalent in healthcare, yet few studies have concurrently measured the appropriateness of alerts with provider responses to alerts. Recent reports of suboptimal alert system design and implementation highlight the need for better evaluation to inform future designs. The authors present a comprehensive framework for evaluating the clinical appropriateness of synchronous, interruptive medication safety alerts. Methods Through literature review and iterative testing, metrics were developed that describe successes, justifiable overrides, provider non-adherence, and unintended adverse consequences of clinical decision support alerts. The framework was validated by applying it to a medication alerting system for patients with acute kidney injury (AKI). Results Through expert review, the framework assesses each alert episode for appropriateness of the alert display and the necessity and urgency of a clinical response. Primary outcomes of the framework include the false positive alert rate, alert override rate, provider non-adherence rate, and rate of provider response appropriateness. Application of the framework to evaluate an existing AKI medication alerting system provided a more complete understanding of the process outcomes measured in the AKI medication alerting system. The authors confirmed that previous alerts and provider responses were most often appropriate. Conclusion The new evaluation model offers a potentially effective method for assessing the clinical appropriateness of synchronous interruptive medication alerts prior to evaluating patient outcomes in a comparative trial. More work can determine the generalizability of the framework for use in other settings and other alert types. PMID:21849334

Clinical Value of Vestibular Evoked Myogenic Potential in Assessing the Stage and Predicting the Hearing Results in Ménière's Disease.

PubMed

Kim, Min-Beom; Choi, Jeesun; Park, Ga Young; Cho, Yang-Sun; Hong, Sung Hwa; Chung, Won-Ho

2013-06-01

Our goal was to find the clinical value of cervical vestibular evoked myogenic potential (VEMP) in Ménière's disease (MD) and to evaluate whether the VEMP results can be useful in assessing the stage of MD. Furthermore, we tried to evaluate the clinical effectiveness of VEMP in predicting hearing outcomes. The amplitude, peak latency and interaural amplitude difference (IAD) ratio were obtained using cervical VEMP. The VEMP results of MD were compared with those of normal subjects, and the MD stages were compared with the IAD ratio. Finally, the hearing changes were analyzed according to their VEMP results. In clinically definite unilateral MD (n=41), the prevalence of cervical VEMP abnormality in the IAD ratio was 34.1%. When compared with normal subjects (n=33), the VEMP profile of MD patients showed a low amplitude and a similar latency. The mean IAD ratio in MD was 23%, which was significantly different from that of normal subjects (P=0.01). As the stage increased, the IAD ratio significantly increased (P=0.09). After stratification by initial hearing level, stage I and II subjects (hearing threshold, 0-40 dB) with an abnormal IAD ratio showed a decrease in hearing over time compared to those with a normal IAD ratio (P=0.08). VEMP parameters have an important clinical role in MD. Especially, the IAD ratio can be used to assess the stage of MD. An abnormal IAD ratio may be used as a predictor of poor hearing outcomes in subjects with early stage MD.

Pilot study of brain morphometry in a sample of Brazilian children with attention deficit hyperactivity disorder: influence of clinical presentation.

PubMed

Pastura, Giuseppe; Kubo, Tadeu Takao Almodovar; Gasparetto, Emerson Leandro; Figueiredo, Otavio; Mattos, Paulo; Prüfer Araújo, Alexandra

2017-12-01

Currently, the diagnosis of attention deficit hyperactivity disorder (ADHD) rests on clinical criteria. Nonetheless, neuroimaging studies have demonstrated that children with ADHD have different cortical thickness and volume measures to typically developing children (TDC). In general, studies do not evaluate the influence of clinical presentation in the brain morphometry of ADHD children. Our objective was to perform a pilot study in order to evaluate cortical thickness and brain volume in a sample of Brazilian ADHD children and compare these to those of TDC, taking into account the influence of clinical presentation. We performed an analytic study comparing 17 drug-naïve ADHD children of both genders, aged between 7 and 10, and 16 TDC. ADHD subjects were first considered as one group and further separated based on clinical presentation. The brain volume did not differ between patients and TDC. Smaller cortical thicknesses were identified on the left superior, medium and inferior temporal cortex, as well as in the left inferior parietal cortex. When compared to TDC, combined and inattentive ADHD presentations depicted smaller cortical thickness with high significance and power. The same magnitude of results was not observed when comparing inattentive ADHD and TDC. In this pilot study, ADHD is associated with abnormalities involving the cortical thickness of the posterior attentional system. The cortical thickness in the left superior, medium and inferior temporal cortex, as well as in the left inferior parietal cortex may differ according to ADHD presentations.

Use of antipsychotic blood levels in clinician decision making: A cross-over study using clinical vignettes of patients with schizophrenia.

PubMed

Savitz, Adam; Melkote, Rama; Riley, Ralph; Pobre, Maria A; McQuarrie, Kelly; Williamson, David; Banderas, Benjamin

2018-05-19

The cause of treatment failure of antipsychotic medications is often difficult to determine in patients with schizophrenia. Evaluation of antipsychotic blood levels (ABLs) may aid clinicians in determining the cause of antipsychotic failure. The Clinical Assessment of the Schizophrenia Patient (CASP) was developed to evaluate clinical decision making during outpatient visits. The CASP assesses changes in medications, psychosocial treatments, and acute interventions along with factors influencing clinical decision making. Nine vignettes representative of clinical situations in patients with schizophrenia were created in two versions (one with ABLs, one without ABLs). The CASP was used to evaluate clinical decisions using the vignettes. Thirty-four clinicians participated in the study. In 8 out of 9 vignettes, most clinicians (at least 89.7%) made a different clinical decision with ABLs compared to without ABLs. In assessing the usefulness of ABLs, a majority (60.7%-85.7%, depending on the vignette) of clinicians responded that ABLs changed their clinical decision for 8 vignettes. Most clinicians (79%-93%) responded that they were more confident in their decisions with ABL information. This study demonstrated that ABLs have the potential to influence clinical decision making in the treatment of patients with schizophrenia. Copyright © 2018. Published by Elsevier B.V.

Economic evaluation of nurse practitioner and clinical nurse specialist roles: A methodological review.

PubMed

Lopatina, Elena; Donald, Faith; DiCenso, Alba; Martin-Misener, Ruth; Kilpatrick, Kelley; Bryant-Lukosius, Denise; Carter, Nancy; Reid, Kim; Marshall, Deborah A

2017-07-01

Advanced practice nurses (e.g., nurse practitioners and clinical nurse specialists) have been introduced internationally to increase access to high quality care and to tackle increasing health care expenditures. While randomised controlled trials and systematic reviews have demonstrated the effectiveness of nurse practitioner and clinical nurse specialist roles, their cost-effectiveness has been challenged. The poor quality of economic evaluations of these roles to date raises the question of whether current economic evaluation guidelines are adequate when examining their cost-effectiveness. To examine whether current guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles. Our methodological review was informed by a qualitative synthesis of four sources of information: 1) narrative review of literature reviews and discussion papers on economic evaluation of advanced practice nursing roles; 2) quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials; 3) review of guidelines for economic evaluation; and, 4) input from an expert panel. The narrative literature review revealed several challenges in economic evaluations of advanced practice nursing roles (e.g., complexity of the roles, variability in models and practice settings where the roles are implemented, and impact on outcomes that are difficult to measure). The quality assessment of economic evaluations of nurse practitioner and clinical nurse specialist roles alongside randomised controlled trials identified methodological limitations of these studies. When we applied the Guidelines for the Economic Evaluation of Health Technologies: Canada to the identified challenges and limitations, discussed those with experts and qualitatively synthesized all findings, we concluded that standard guidelines for economic evaluation are appropriate for economic evaluations of nurse practitioner and clinical nurse specialist roles and should be routinely followed. However, seven out of 15 current guideline sections (describing a decision problem, choosing type of economic evaluation, selecting comparators, determining the study perspective, estimating effectiveness, measuring and valuing health, and assessing resource use and costs) may require additional role-specific considerations to capture costs and effects of these roles. Current guidelines for economic evaluation should form the foundation for economic evaluations of nurse practitioner and clinical nurse specialist roles. The proposed role-specific considerations, which clarify application of standard guidelines sections to economic evaluation of nurse practitioner and clinical nurse specialist roles, may strengthen the quality and comprehensiveness of future economic evaluations of these roles. Copyright © 2017 Elsevier Ltd. All rights reserved.

A comparative evaluation of subepithelial connective tissue graft (SCTG) versus platelet concentrate graft (PCG) in the treatment of gingival recession using coronally advanced flap technique: A 12-month study

PubMed Central

Kumar, G. Naveen Vital; Murthy, K. Raja Venkatesh

2013-01-01

Objective: The objective of this study was to clinically evaluate and compare the efficacy of platelet concentrate graft (PCG) with that of subepithelial connective tissue graft (SCTG) using a coronally advanced flap technique in the treatment of gingival recession. Materials and Methods: Twelve patients with a total of 24 gingival recession defects were selected and randomly assigned either to experimental site-A (SCTG) or experimental site-B (PCG). The clinical parameters were recorded at baseline up to 12 months post-operatively and compared. Results: The mean vertical recession depth (VRD) statistically significantly decreased from 2.50 ± 0.48 mm to 0.54 ± 0.50 mm with PCG and from 2.75 ± 0.58 mm to 0.54 ± 0.45 mm with SCTG at 12 months. No statistically significant differences between the treatments were found for VRD and clinical attachment level (CAL), while keratinized tissue width (KTW) gain was statistically significant. Conclusion: Both the SCTG and the PCG group resulted in a significant amount of root coverage. The PCG technique was less invasive and required minimal time and clinical maneuver. It resulted in superior aesthetic outcome and lower post-surgical discomfort at the 12 months follow-up. PMID:24554889

Automated brain volumetrics in multiple sclerosis: a step closer to clinical application

PubMed Central

Beadnall, H N; Hatton, S N; Bader, G; Tomic, D; Silva, D G

2016-01-01

Background Whole brain volume (WBV) estimates in patients with multiple sclerosis (MS) correlate more robustly with clinical disability than traditional, lesion-based metrics. Numerous algorithms to measure WBV have been developed over the past two decades. We compare Structural Image Evaluation using Normalisation of Atrophy-Cross-sectional (SIENAX) to NeuroQuant and MSmetrix, for assessment of cross-sectional WBV in patients with MS. Methods MRIs from 61 patients with relapsing-remitting MS and 2 patients with clinically isolated syndrome were analysed. WBV measurements were calculated using SIENAX, NeuroQuant and MSmetrix. Statistical agreement between the methods was evaluated using linear regression and Bland-Altman plots. Precision and accuracy of WBV measurement was calculated for (1) NeuroQuant versus SIENAX and (2) MSmetrix versus SIENAX. Results Precision (Pearson's r) of WBV estimation for NeuroQuant and MSmetrix versus SIENAX was 0.983 and 0.992, respectively. Accuracy (Cb) was 0.871 and 0.994, respectively. NeuroQuant and MSmetrix showed a 5.5% and 1.0% volume difference compared with SIENAX, respectively, that was consistent across low and high values. Conclusions In the analysed population, NeuroQuant and MSmetrix both quantified cross-sectional WBV with comparable statistical agreement to SIENAX, a well-validated cross-sectional tool that has been used extensively in MS clinical studies. PMID:27071647

Clinical competence of Guatemalan and Mexican physicians for family dysfunction management.

PubMed

Cabrera-Pivaral, Carlos Enrique; Orozco-Valerio, María de Jesús; Celis-de la Rosa, Alfredo; Covarrubias-Bermúdez, María de Los Ángeles; Zavala-González, Marco Antonio

2017-01-01

To evaluate the clinical competence of Mexican and Guatemalan physicians to management the family dysfunction. Cross comparative study in four care units first in Guadalajara, Mexico, and four in Guatemala, Guatemala, based on a purposeful sampling, involving 117 and 100 physicians, respectively. Clinical competence evaluated by validated instrument integrated for 187 items. Non-parametric descriptive and inferential statistical analysis was performed. The percentage of Mexican physicians with high clinical competence was 13.7%, medium 53%, low 24.8% and defined by random 8.5%. For the Guatemalan physicians'14% was high, average 63%, and 23% defined by random. There were no statistically significant differences between healthcare country units, but between the medium of Mexicans (0.55) and Guatemalans (0.55) (p = 0.02). The proportion of the high clinical competency of Mexican physicians' was as Guatemalans.

Analytical and Clinical Performance Evaluation of the Abbott Architect PIVKA Assay.

PubMed

Ko, Dae-Hyun; Hyun, Jungwon; Kim, Hyun Soo; Park, Min-Jeong; Kim, Jae-Seok; Park, Ji-Young; Shin, Dong Hoon; Cho, Hyoun Chan

2018-01-01

Protein induced by vitamin K absence (PIVKA) is measured using various assays and is used to help diagnose hepatocellular carcinoma. The present study evaluated the analytical and clinical performances of the recently released Abbott Architect PIVKA assay. Precision, linearity, and correlation tests were performed in accordance with the Clinical Laboratory Standardization Institute guidelines. Sample type suitability was assessed using serum and plasma samples from the same patients, and the reference interval was established using sera from 204 healthy individuals. The assay had coefficients of variation of 3.2-3.5% and intra-laboratory variation of 3.6-5.5%. Linearity was confirmed across the entire measurable range. The Architect PIVKA assay was comparable to the Lumipulse PIVKA assay, and the plasma and serum samples provided similar results. The lower reference limit was 13.0 mAU/mL and the upper reference limit was 37.4 mAU/mL. The ability of the Architect PIVKA assay to detect hepatocellular carcinoma was comparable to that of the alpha-fetoprotein test and the Lumipulse PIVKA assay. The Architect PIVKA assay provides excellent analytical and clinical performance, is simple for clinical laboratories to adopt, and has improved sample type suitability that could broaden the assay's utility. © 2018 by the Association of Clinical Scientists, Inc.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class.

PubMed

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober's test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober's test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important.

Examining the postural awareness and flexibility changes in physical therapy students who took clinical Pilates class

PubMed Central

Atilgan, Esra; Tarakci, Devrim; Mutluay, Fatma

2017-01-01

Objective: This study aimed to evaluate postural awareness and changes in posture and flexibility of students who took Clinical Pilates class as an elective course at the undergraduate level. Methods: The study conducted from 2013-2016 included 98 students who took Clinical Pilates class at the Department of Physical Therapy and Rehabilitation, School of Health Sciences, Istanbul Medipol University, Turkey. The flexibility levels of the study participants were measured before and after the Clinical Pilates education using finger-to-floor test and modified Schober’s test. Observational posture analysis and postural awareness were recorded using the scale prepared by the researchers. Results: The post-education evaluations showed that postural distortions were fixed, and a significant increase in the postural awareness of the students was observed compared with the pre-education period. The results of both modified Schober’s test and finger-to-floor test, which were used to measure the flexibility levels, showed a statistically significant increase in post-education scores compared with those of the pre-education period. Conclusion: This study showed that the Clinical Pilates course increased postural awareness and flexibility of physical therapy students and fixed postural distortions. Thus, the inclusion of Clinical Pilates class in the undergraduate education is considered to be important. PMID:28811786

Left ventricular early diastolic inflow velocity and atrial ventricular plane downward velocity: useful parameters to test diastolic function in clinical practice? Diastolic parameters tested in a clinical setting.

PubMed

Winter, R; Gudmundsson, P; Ericsson, G; Willenheimer, R

2001-06-01

To study the clinical value of the colour-M-mode slope of the early diastolic left ventricular filling phase (Vp) and the early diastolic downward M-mode slope of the left atrioventricular plane displacement (EDS), compared with diastolic function assessed by traditional Doppler evaluation. In 65 consecutive patients EDS and Vp were compared with a four-degree traditional diastolic function classification, based on pulsed Doppler assessment of the early to atrial transmitral flow ratio (E/A), the E-wave deceleration time (Edt), and the systolic to diastolic (S/D) pulmonary venous inflow ratio. Vp (P=0.006) and EDS (P=0.045) were related to traditional diastolic function (Kruskal--Wallis analysis). EDS showed a trend brake between the moderate and severe diastolic dysfunction groups by traditional Doppler evaluation. Vp and EDS correlated weakly in simple linear regression analysis (r=0.33). Vp and EDS discriminated poorly between normal and highly abnormal diastolic function. Vp and EDS were significantly related to diastolic function by traditional Doppler evaluation. They were, however, not useful as single parameters of left ventricular diastolic function due to a small difference between normal and highly abnormal values, allowing for little between-measurement variability. Consequently, these methods for the evaluation of left ventricular diastolic function do not add significantly to traditional Doppler evaluation.

Comparative effectiveness research in practice and policy for radiation oncology.

PubMed

Lawrence, William F

2014-01-01

Interest in comparative effectiveness research (CER) has increased dramatically over the past decade, yet perceptions about what comprises CER varies. CER has several attributes relevant to practice and policy: (1) The goal of CER is to inform decisions about health care. (2) Literature synthesis is used in addition to primary research. (3) CER evaluates not only overall outcomes for the population but also evaluates subgroups that may have heterogeneous outcomes. (4) Research places an emphasis on outcomes in the "real-world" settings. (5) Outcomes studied should be relevant to patients. In radiation oncology, where many of the traditional clinical trials are comparative in nature, the line between CER and "traditional" research may be blurred, but an increased emphasis on CER can help to bridge the research enterprise and clinical practice, helping to inform decision making at the patient, clinician, and policy levels. © 2013 Published by Elsevier Inc.

Quality of Life in Patients with Neurocysticercosis in Mexico

PubMed Central

Bhattarai, Rachana; Budke, Christine M.; Carabin, Hélène; Proaño, Jefferson V.; Flores-Rivera, Jose; Corona, Teresa; Cowan, Linda D.; Ivanek, Renata; Snowden, Karen F.; Flisser, Ana

2011-01-01

The objective of this study was to compare quality of life measures in patients with neurocysticercosis (NCC) to those of a matched control group. The NCC outpatients and their controls were recruited from two neurology referral hospitals in Mexico City, Mexico during 2007–2008. The quality of life of 224 NCC patients was compared with 224 age-sex-hospital-day matched controls using the short form 12 v2 (SF-12 v2) quality of life survey. Medical chart reviews were also conducted for the NCC outpatients to evaluate presenting clinical manifestations. Compared with the controls, NCC patients had a significantly lower score for each of the eight domains of health evaluated and significantly lower Physical and Mental Component Summary scores. Chart reviews indicated that hydrocephalus (48%), severe headaches (47%), and epilepsy (31%) were the most common clinical manifestations in these NCC outpatients. PMID:21540389

An Evaluation of the Clinical Performance of Newly Qualified Nurses: A Competency Based Assessment.

ERIC Educational Resources Information Center

O'Connor, S. E.; Pearce, J.; Smith, R. L.; Voegeli, D.; Walton, P.

2001-01-01

Senior nurses' (n=139) expectations of 36 beginning nurses were compared with the beginners' competence ratings by their clinical preceptors. Senior nurses' expectations were lower than the actual competence demonstrated by the graduates, suggesting that assessment instruments should not be derived solely from supervisor expectations. (SK)

Randomized Clinical Trial of Motivational Enhancement of Substance Use Treatment among Incarcerated Adolescents: Post-Release Condom Non-Use

ERIC Educational Resources Information Center

Rosengard, Cynthia; Stein, L. A. R.; Barnett, Nancy P.; Monti, Peter M.; Golembeske, Charles; Lebeau-Craven, Rebecca; Miranda, Robert

2007-01-01

Evaluated impact of motivational enhancement (ME) of substance abuse treatment compared to relaxation training (RT) on sex without condoms (overall and involving substance use) 3 months following release among incarcerated adolescents. This randomized clinical trial involved 114 incarcerated adolescents from the Northeast. Regression analyses…

Mandibular bone structure, bone mineral density, and clinical variables as fracture predictors: a 15-year follow-up of female patients in a dental clinic.

PubMed

Jonasson, Grethe; Billhult, Annika

2013-09-01

To compare three mandibular trabeculation evaluation methods, clinical variables, and osteoporosis as fracture predictors in women. One hundred and thirty-six female dental patients (35-94 years) answered a questionnaire in 1996 and 2011. Using intra-oral radiographs from 1996, five methods were compared as fracture predictors: (1) mandibular bone structure evaluated with a visual radiographic index, (2) bone texture, (3) size and number of intertrabecular spaces calculated with Jaw-X software, (4) fracture probability calculated with a fracture risk assessment tool (FRAX), and (5) osteoporosis diagnosis based on dual-energy-X-ray absorptiometry. Differences were assessed with the Mann-Whitney test and relative risk calculated. Previous fracture, gluco-corticoid medication, and bone texture were significant indicators of future and total (previous plus future) fracture. Osteoporosis diagnosis, sparse trabeculation, Jaw-X, and FRAX were significant predictors of total but not future fracture. Clinical and oral bone variables may identify individuals at greatest risk of fracture. Copyright © 2013 Elsevier Inc. All rights reserved.

Evaluation of an instructional model to teach clinically relevant medicinal chemistry in a campus and a distance pathway.

PubMed

Alsharif, Naser Z; Galt, Kimberly A

2008-04-15

To evaluate an instructional model for teaching clinically relevant medicinal chemistry. An instructional model that uses Bloom's cognitive and Krathwohl's affective taxonomy, published and tested concepts in teaching medicinal chemistry, and active learning strategies, was introduced in the medicinal chemistry courses for second-professional year (P2) doctor of pharmacy (PharmD) students (campus and distance) in the 2005-2006 academic year. Student learning and the overall effectiveness of the instructional model were assessed. Student performance after introducing the instructional model was compared to that in prior years. Student performance on course examinations improved compared to previous years. Students expressed overall enthusiasm about the course and better understood the value of medicinal chemistry to clinical practice. The explicit integration of the cognitive and affective learning objectives improved student performance, student ability to apply medicinal chemistry to clinical practice, and student attitude towards the discipline. Testing this instructional model provided validation to this theoretical framework. The model is effective for both our campus and distance-students. This instructional model may also have broad-based applications to other science courses.

A quantitative benefit-risk assessment approach to improve decision making in drug development: Application of a multicriteria decision analysis model in the development of combination therapy for overactive bladder.

PubMed

de Greef-van der Sandt, I; Newgreen, D; Schaddelee, M; Dorrepaal, C; Martina, R; Ridder, A; van Maanen, R

2016-04-01

A multicriteria decision analysis (MCDA) approach was developed and used to estimate the benefit-risk of solifenacin and mirabegron and their combination in the treatment of overactive bladder (OAB). The objectives were 1) to develop an MCDA tool to compare drug effects in OAB quantitatively, 2) to establish transparency in the evaluation of the benefit-risk profile of various dose combinations, and 3) to quantify the added value of combination use compared to monotherapies. The MCDA model was developed using efficacy, safety, and tolerability attributes and the results of a phase II factorial design combination study were evaluated. Combinations of solifenacin 5 mg and mirabegron 25 mg and mirabegron 50 (5+25 and 5+50) scored the highest clinical utility and supported combination therapy development of solifenacin and mirabegron for phase III clinical development at these dose regimens. This case study underlines the benefit of using a quantitative approach in clinical drug development programs. © 2015 The American Society for Clinical Pharmacology and Therapeutics.

Disc displacement without reduction: a retrospective study of a clinical diagnostic sign.

PubMed

Giraudeau, Anne; Jeany, Marion; Ehrmann, Elodie; Déjou, Jacques; Ouni, Imed; Orthlieb, Jean-Daniel

2017-03-01

The purpose of this retrospective study is to evaluate a clinical diagnostic sign for disc displacement without reduction (DDWR), the absence of additional condylar translation during opening compared with protrusion. Thirty-eight electronic axiographic and magnetic resonance imaging (MRI) examinations of the TMJ were analyzed in order to compare the opening/protrusion ratio of condylar translation between non-painful DDWR and non-DDWR. According to the Mann-Whitney U test, the opening/protrusion ratio in non-painful DDWR differs significantly from non-DDWR (p < 0.0001). Among non-painful DDWR, there is no additional condylar translation during opening in comparison with protrusion, and this is probably also the case for DDWR without limited opening, which is a subtype that has not been validated by the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD). Comparative condylar palpation can analyze this sign, and therefore, further comparative investigations between MRI and clinical examination are needed to validate the corresponding clinical test.

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.

Low Cardiorespiratory Fitness in African Americans: A Health Disparity Risk Factor?

PubMed Central

Swift, Damon L.; Staiano, Amanda E.; Johannsen, Neil M.; Lavie, Carl J.; Earnest, Conrad P.; Katzmarzyk, Peter T.; Blair, Steven N.; Newton, Robert L.; Church, Timothy S.

2013-01-01

Low cardiorespiratory fitness (CRF) is a well-established risk factor for all-cause and cardiovascular disease mortality. African Americans have higher rates of cardiovascular disease compared to their Caucasian counterparts. However, the extent to which lower CRF levels contribute to the excess risk in African Americans has not been fully explored. The purpose of this review is to: 1) explore the literature evaluating the relationship between CRF and mortality specifically in African American populations; and 2) critically evaluate the studies which have compared CRF between African American and Caucasians in epidemiological studies and clinical trials. We have further discussed several potential mechanisms that may contribute to the observation of lower CRF levels in African American compared to Caucasian adults including potential racial differences in physical activity levels, muscle fiber type distribution, and hemoglobin levels. If lower CRF is generally present in African Americans compared to Caucasians, and is of a clinically meaningful difference, this may represent an important public health concern. PMID:23982718

Do clinical safety charts improve paramedic key performance indicator results? (A clinical improvement programme evaluation).

PubMed

Ebbs, Phillip; Middleton, Paul M; Bonner, Ann; Loudfoot, Allan; Elliott, Peter

2012-07-01

Is the Clinical Safety Chart clinical improvement programme (CIP) effective at improving paramedic key performance indicator (KPI) results within the Ambulance Service of New South Wales? The CIP intervention area was compared with the non-intervention area in order to determine whether there was a statistically significant improvement in KPI results. The CIP was associated with a statistically significant improvement in paramedic KPI results within the intervention area. The strategies used within this CIP are recommended for further consideration.

The NICE recommendation for drug-coated balloons and its global impact.

PubMed

Eccleshall, Simon; Waliszewski, M

2015-06-01

The clinical efficacy and safety of drug-coated balloon (DCB) angioplasty in patients with coronary in-stent restenosis (ISR) has been demonstrated. The objective of this article is to provide comparative cost efficacy data for DCB angioplasty in various countries based on the original methodology of the Medical Technologies Evaluation Programme (MTEP) at the National Institute for Health and Clinical Excellence (NICE) in 2010. Published and unpublished Health Technology Assessment (HTA) reports were evaluated for comparison in selected countries. Furthermore, a systematic review of economic evaluations of DCB angioplasty versus standard treatments (uncoated balloon angioplasty or drug-eluting stent implantations) was conducted. National cost efficacy data were evaluated using Markov state transition models which were adapted to fit each country's device and procedure related costs. The clinical input for adverse events was defined with two relevant trials for in-stent restenosis of bare metal stents (BMS-ISR) and of drug-eluting stents (DES-ISR). In the UK, Germany, Switzerland, South Africa, Japan and Brazil, DCB angioplasty is cost-effective when compared with drug-eluting stents to treat either BMS-ISR or DES-ISR. DCB angioplasty ought to be the preferred treatment option for patients with BMS-ISR and DES-ISR from the payers' point of view. © The Author(s), 2015.

Method using in vivo quantitative spectroscopy to guide design and optimization of low-cost, compact clinical imaging devices: emulation and evaluation of multispectral imaging systems

NASA Astrophysics Data System (ADS)

Saager, Rolf B.; Baldado, Melissa L.; Rowland, Rebecca A.; Kelly, Kristen M.; Durkin, Anthony J.

2018-04-01

With recent proliferation in compact and/or low-cost clinical multispectral imaging approaches and commercially available components, questions remain whether they adequately capture the requisite spectral content of their applications. We present a method to emulate the spectral range and resolution of a variety of multispectral imagers, based on in-vivo data acquired from spatial frequency domain spectroscopy (SFDS). This approach simulates spectral responses over 400 to 1100 nm. Comparing emulated data with full SFDS spectra of in-vivo tissue affords the opportunity to evaluate whether the sparse spectral content of these imagers can (1) account for all sources of optical contrast present (completeness) and (2) robustly separate and quantify sources of optical contrast (crosstalk). We validate the approach over a range of tissue-simulating phantoms, comparing the SFDS-based emulated spectra against measurements from an independently characterized multispectral imager. Emulated results match the imager across all phantoms (<3 % absorption, <1 % reduced scattering). In-vivo test cases (burn wounds and photoaging) illustrate how SFDS can be used to evaluate different multispectral imagers. This approach provides an in-vivo measurement method to evaluate the performance of multispectral imagers specific to their targeted clinical applications and can assist in the design and optimization of new spectral imaging devices.

Comparison of virtual patient simulation with mannequin-based simulation for improving clinical performances in assessing and managing clinical deterioration: randomized controlled trial.

PubMed

Liaw, Sok Ying; Chan, Sally Wai-Chi; Chen, Fun-Gee; Hooi, Shing Chuan; Siau, Chiang

2014-09-17

Virtual patient simulation has grown substantially in health care education. A virtual patient simulation was developed as a refresher training course to reinforce nursing clinical performance in assessing and managing deteriorating patients. The objective of this study was to describe the development of the virtual patient simulation and evaluate its efficacy, by comparing with a conventional mannequin-based simulation, for improving the nursing students' performances in assessing and managing patients with clinical deterioration. A randomized controlled study was conducted with 57 third-year nursing students who were recruited through email. After a baseline evaluation of all participants' clinical performance in a simulated environment, the experimental group received a 2-hour fully automated virtual patient simulation while the control group received 2-hour facilitator-led mannequin-based simulation training. All participants were then re-tested one day (first posttest) and 2.5 months (second posttest) after the intervention. The participants from the experimental group completed a survey to evaluate their learning experiences with the newly developed virtual patient simulation. Compared to their baseline scores, both experimental and control groups demonstrated significant improvements (P<.001) in first and second post-test scores. While the experimental group had significantly lower (P<.05) second post-test scores compared with the first post-test scores, no significant difference (P=.94) was found between these two scores for the control group. The scores between groups did not differ significantly over time (P=.17). The virtual patient simulation was rated positively. A virtual patient simulation for a refreshing training course on assessing and managing clinical deterioration was developed. Although the randomized controlled study did not show that the virtual patient simulation was superior to mannequin-based simulation, both simulations have demonstrated to be effective refresher learning strategies for improving nursing students' clinical performance. Given the greater resource requirements of mannequin-based simulation, the virtual patient simulation provides a more promising alternative learning strategy to mitigate the decay of clinical performance over time.

[Embryo selection in IVF/ICSI cycles using time-lapse microscopy and the clinical outcomes].

PubMed

Chen, Minghao; Huang, Jun; Zhong, Ying; Quan, Song

2015-12-01

To compare the clinical outcomes of embryos selected using time-lapse microscopy and traditional morphological method in IVF/ICSI cycles and evaluate the clinical value of time-lapse microscopy in early embryo monitoring and selection. e retrospectively analyzed the clinical data of 139 IVF/ICSI cycles with embryo selection based on time-lapse monitoring (TLM group, n=68) and traditional morphological method (control group, n=71). The βHCG-positive rate, clinical pregnancy rate and embryo implantation rate were compared between the 2 groups. Subgroup analysis was performed in view of female patients age and the fertilization type. The βHCG-positive rate, clinical pregnancy rate and implantation rate were 66.2%, 61.8% and 47.1% in TLM group, significantly higher than those in the control group (47.9%, 43.7% and 30.3%, respectively; P<0.05). Compared with patients below 30 years of age, patients aged between 31 and 35 years benefited more from time-lapse monitoring with improved clinical outcomes. time-lapse monitoring significantly increased the βHCG-positive rate, clinical pregnancy rate and implantation rate for patients undergoing IVF cycles, but not for those undergoing ICSI or TESA cycles. Compared with those selected using traditional morphological method, the embryos selected with time-lapse microscopy have better clinical outcomes, especially in older patients (31-35 years of age) and in IVF cycles.

Method Development for Clinical Comprehensive Evaluation of Pediatric Drugs Based on Multi-Criteria Decision Analysis: Application to Inhaled Corticosteroids for Children with Asthma.

PubMed

Yu, Yuncui; Jia, Lulu; Meng, Yao; Hu, Lihua; Liu, Yiwei; Nie, Xiaolu; Zhang, Meng; Zhang, Xuan; Han, Sheng; Peng, Xiaoxia; Wang, Xiaoling

2018-04-01

Establishing a comprehensive clinical evaluation system is critical in enacting national drug policy and promoting rational drug use. In China, the 'Clinical Comprehensive Evaluation System for Pediatric Drugs' (CCES-P) project, which aims to compare drugs based on clinical efficacy and cost effectiveness to help decision makers, was recently proposed; therefore, a systematic and objective method is required to guide the process. An evidence-based multi-criteria decision analysis model that involved an analytic hierarchy process (AHP) was developed, consisting of nine steps: (1) select the drugs to be reviewed; (2) establish the evaluation criterion system; (3) determine the criterion weight based on the AHP; (4) construct the evidence body for each drug under evaluation; (5) select comparative measures and calculate the original utility score; (6) place a common utility scale and calculate the standardized utility score; (7) calculate the comprehensive utility score; (8) rank the drugs; and (9) perform a sensitivity analysis. The model was applied to the evaluation of three different inhaled corticosteroids (ICSs) used for asthma management in children (a total of 16 drugs with different dosage forms and strengths or different manufacturers). By applying the drug analysis model, the 16 ICSs under review were successfully scored and evaluated. Budesonide suspension for inhalation (drug ID number: 7) ranked the highest, with comprehensive utility score of 80.23, followed by fluticasone propionate inhaled aerosol (drug ID number: 16), with a score of 79.59, and budesonide inhalation powder (drug ID number: 6), with a score of 78.98. In the sensitivity analysis, the ranking of the top five and lowest five drugs remains unchanged, suggesting this model is generally robust. An evidence-based drug evaluation model based on AHP was successfully developed. The model incorporates sufficient utility and flexibility for aiding the decision-making process, and can be a useful tool for the CCES-P.

Data from the US and UK cystic fibrosis registries support disease modification by CFTR modulation with ivacaftor.

PubMed

Bessonova, Leona; Volkova, Nataliya; Higgins, Mark; Bengtsson, Leif; Tian, Simon; Simard, Christopher; Konstan, Michael W; Sawicki, Gregory S; Sewall, Ase; Nyangoma, Stephen; Elbert, Alexander; Marshall, Bruce C; Bilton, Diana

2018-05-10

Ivacaftor is the first cystic fibrosis transmembrane conductance regulator (CFTR) modulator demonstrating clinical benefit in patients with cystic fibrosis (CF). As ivacaftor is intended for chronic, lifelong use, understanding long-term effects is important for patients and healthcare providers. This ongoing, observational, postapproval safety study evaluates clinical outcomes and disease progression in ivacaftor-treated patients using data from the US and the UK CF registries following commercial availability. Annual analyses compare ivacaftor-treated and untreated matched comparator patients for: risks of death, transplantation, hospitalisation, pulmonary exacerbation; prevalence of CF-related complications and microorganisms and lung function changes in a subset of patients who initiated ivacaftor in the first year of commercial availability. Results from the 2014 analyses (2 and 3 years following commercial availability in the UK and USA, respectively) are presented here. Analyses included 1256 ivacaftor-treated and 6200 comparator patients from the USA and 411 ivacaftor-treated and 2069 comparator patients from the UK. No new safety concerns were identified based on the evaluation of clinical outcomes included in the analyses. As part of safety evaluations, ivacaftor-treated US patients were observed to have significantly lower risks of death (0.6% vs 1.6%, p=0.0110), transplantation (0.2% vs 1.1%, p=0.0017), hospitalisation (27.5% vs 43.1%, p<0.0001) and pulmonary exacerbation (27.8% vs 43.3%, p<0.0001) relative to comparators; trends were similar in the UK. In both registries, ivacaftor-treated patients had a lower prevalence of CF-related complications and select microorganisms and had better preserved lung function. While general limitations of observational research apply, analyses revealed favourable results for clinically important outcomes among ivacaftor-treated patients, adding to the growing body of literature supporting disease modification by CFTR modulation with ivacaftor. EUPAS4270. © 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.

Single-Dose Oritavancin Treatment of Acute Bacterial Skin and Skin Structure Infections: SOLO Trial Efficacy by Eron Severity and Management Setting.

PubMed

Deck, Daniel H; Jordan, Jennifer M; Holland, Thomas L; Fan, Weihong; Wikler, Matthew A; Sulham, Katherine A; Ralph Corey, G

2016-09-01

Introduction of new antibiotics enabling single-dose administration, such as oritavancin may significantly impact site of care decisions for patients with acute bacterial skin and skin structure infections (ABSSSI). This analysis compared the efficacy of single-dose oritavancin with multiple-dose vancomycin in patients categorized according to disease severity via modified Eron classification and management setting. SOLO I and II were phase 3 studies evaluating single-dose oritavancin versus 7-10 days of vancomycin for treatment of ABSSSI. Patient characteristics were collected at baseline and retrospectively analyzed. Study protocols were amended, allowing outpatient management at the discretion of investigators. In this post hoc analysis, patients were categorized according to a modified Eron severity classification and management setting (outpatient vs. inpatient) and the efficacy compared. Overall, 1910 patients in the SOLO trials were categorized into Class I (520, 26.5%), II (790, 40.3%), and III (600, 30.6%). Of the 767 patients (40%) in the SOLO trials who were managed entirely in the outpatient setting 40.3% were categorized as Class II and 30.6% were Class III. Clinical efficacy was similar between oritavancin and vancomycin treatment groups, regardless of severity classification and across inpatient and outpatient settings. Class III patients had lower response rates (oritavancin 73.3%, vancomycin 76.6%) at early clinical evaluation when compared to patients in Class I (82.6%) or II (86.1%); however, clinical cure rates at the post-therapy evaluation were similar for Class III patients (oritavancin 79.8%, vancomycin 79.9%) when compared to Class I and II patients (79.1-85.7%). Single-dose oritavancin therapy results in efficacy comparable to multiple-dose vancomycin in patients categorized according to modified Eron disease severity classification regardless of whether management occurred in the inpatient or outpatient setting. The Medicines Company, Parsippany, NJ, USA. ClinicalTrials.gov identifiers, NCT01252719 (SOLO I) and NCT01252732 (SOLO II).

Future Directions for Cardiovascular Disease Comparative Effectiveness Research

PubMed Central

Hlatky, Mark A; Douglas, Pamela S; Cook, Nakela L; Wells, Barbara; Benjamin, Emelia J; Dickersin, Kay; Goff, David C; Hirsch, Alan T; Hylek, Elaine M; Peterson, Eric; Roger, Véronique L; Selby, Joseph V; Udelson, James E; Lauer, Michael S

2012-01-01

Comparative effectiveness research (CER) aims to provide decision-makers the evidence needed to evaluate the benefits and harms of alternative clinical management strategies. CER has become a national priority, with considerable new research funding allocated. Cardiovascular disease is a priority area for CER. This workshop report provides an overview of CER methods, with an emphasis on practical clinical trials and observational treatment comparisons. The report also details recommendations to the National Heart Lung and Blood Institute for a new framework for evidence development to foster cardiovascular CER, and specific studies to address eight clinical issues identified by the Institute of Medicine as high priorities for cardiovascular CER. PMID:22796257

Hospital competition, resource allocation and quality of care

PubMed Central

Mukamel, Dana B; Zwanziger, Jack; Bamezai, Anil

2002-01-01

Background A variety of approaches have been used to contain escalating hospital costs. One approach is intensifying price competition. The increase in price based competition, which changes the incentives hospitals face, coupled with the fact that consumers can more easily evaluate the quality of hotel services compared with the quality of clinical care, may lead hospitals to allocate more resources into hotel rather than clinical services. Methods To test this hypothesis we studied hospitals in California in 1982 and 1989, comparing resource allocations prior to and following selective contracting, a period during which the focus of competition changed from quality to price. We estimated the relationship between clinical outcomes, measured as risk-adjusted-mortality rates, and resources. Results In 1989, higher competition was associated with lower clinical expenditures levels compared with 1982. The trend was stronger for non-profit hospitals. Lower clinical resource use was associated with worse risk adjusted mortality outcomes. Conclusions This study raises concerns that cost reductions may be associated with increased mortality. PMID:12052258

Defining and reconstructing clinical processes based on IHE and BPMN 2.0.

PubMed

Strasser, Melanie; Pfeifer, Franz; Helm, Emmanuel; Schuler, Andreas; Altmann, Josef

2011-01-01

This paper describes the current status and the results of our process management system for defining and reconstructing clinical care processes, which contributes to compare, analyze and evaluate clinical processes and further to identify high cost tasks or stays. The system is founded on IHE, which guarantees standardized interfaces and interoperability between clinical information systems. At the heart of the system there is BPMN, a modeling notation and specification language, which allows the definition and execution of clinical processes. The system provides functionality to define healthcare information system independent clinical core processes and to execute the processes in a workflow engine. Furthermore, the reconstruction of clinical processes is done by evaluating an IHE audit log database, which records patient movements within a health care facility. The main goal of the system is to assist hospital operators and clinical process managers to detect discrepancies between defined and actual clinical processes and as well to identify main causes of high medical costs. Beyond that, the system can potentially contribute to reconstruct and improve clinical processes and enhance cost control and patient care quality.

The Biomarker-Surrogacy Evaluation Schema: a review of the biomarker-surrogate literature and a proposal for a criterion-based, quantitative, multidimensional hierarchical levels of evidence schema for evaluating the status of biomarkers as surrogate endpoints.

PubMed

Lassere, Marissa N

2008-06-01

There are clear advantages to using biomarkers and surrogate endpoints, but concerns about clinical and statistical validity and systematic methods to evaluate these aspects hinder their efficient application. Section 2 is a systematic, historical review of the biomarker-surrogate endpoint literature with special reference to the nomenclature, the systems of classification and statistical methods developed for their evaluation. In Section 3 an explicit, criterion-based, quantitative, multidimensional hierarchical levels of evidence schema - Biomarker-Surrogacy Evaluation Schema - is proposed to evaluate and co-ordinate the multiple dimensions (biological, epidemiological, statistical, clinical trial and risk-benefit evidence) of the biomarker clinical endpoint relationships. The schema systematically evaluates and ranks the surrogacy status of biomarkers and surrogate endpoints using defined levels of evidence. The schema incorporates the three independent domains: Study Design, Target Outcome and Statistical Evaluation. Each domain has items ranked from zero to five. An additional category called Penalties incorporates additional considerations of biological plausibility, risk-benefit and generalizability. The total score (0-15) determines the level of evidence, with Level 1 the strongest and Level 5 the weakest. The term ;surrogate' is restricted to markers attaining Levels 1 or 2 only. Surrogacy status of markers can then be directly compared within and across different areas of medicine to guide individual, trial-based or drug-development decisions. This schema would facilitate communication between clinical, researcher, regulatory, industry and consumer participants necessary for evaluation of the biomarker-surrogate-clinical endpoint relationship in their different settings.

A study on mastectomy samples to evaluate breast imaging quality and potential clinical relevance of differential phase contrast mammography.

PubMed

Hauser, Nik; Wang, Zhentian; Kubik-Huch, Rahel A; Trippel, Mafalda; Singer, Gad; Hohl, Michael K; Roessl, Ewald; Köhler, Thomas; van Stevendaal, Udo; Wieberneit, Nataly; Stampanoni, Marco

2014-03-01

Differential phase contrast and scattering-based x-ray mammography has the potential to provide additional and complementary clinically relevant information compared with absorption-based mammography. The purpose of our study was to provide a first statistical evaluation of the imaging capabilities of the new technique compared with digital absorption mammography. We investigated non-fixed mastectomy samples of 33 patients with invasive breast cancer, using grating-based differential phase contrast mammography (mammoDPC) with a conventional, low-brilliance x-ray tube. We simultaneously recorded absorption, differential phase contrast, and small-angle scattering signals that were combined into novel high-frequency-enhanced images with a dedicated image fusion algorithm. Six international, expert breast radiologists evaluated clinical digital and experimental mammograms in a 2-part blinded, prospective independent reader study. The results were statistically analyzed in terms of image quality and clinical relevance. The results of the comparison of mammoDPC with clinical digital mammography revealed the general quality of the images to be significantly superior (P < 0.001); sharpness, lesion delineation, as well as the general visibility of calcifications to be significantly more assessable (P < 0.001); and delineation of anatomic components of the specimens (surface structures) to be significantly sharper (P < 0.001). Spiculations were significantly better identified, and the overall clinically relevant information provided by mammoDPC was judged to be superior (P < 0.001). Our results demonstrate that complementary information provided by phase and scattering enhanced mammograms obtained with the mammoDPC approach deliver images of generally superior quality. This technique has the potential to improve radiological breast diagnostics.

Evaluation of a Novel Single-Tube Method for Extended Genotyping of Human Papillomavirus

PubMed Central

Serrano, I.; Wennington, H.; Graham, C.; Cubie, H.; Boland, E.; Fu, G.; Cuschieri, K.

2017-01-01

ABSTRACT The use of high-risk human papillomavirus (HPV) testing for surveillance and clinical applications is increasing globally, and it is important that tests are evaluated to ensure they are fit for this purpose. In this study, the performance of a new HPV genotyping test, the Papilloplex high-risk HPV (HR-HPV) test, was compared to two well-established genotyping tests. Preliminary clinical performance was also ascertained for the detection of CIN2+ in a disease-enriched retrospective cohort. A panel of 500 cervical liquid-based cytology samples with known clinical outcomes were tested by the Papilloplex HR-HPV test. Analytical concordance was compared to two assays: a Linear Array (LA) HPV genotyping test and an Optiplex HPV genotyping test. The initial clinical performance for the detection for CIN2+ samples was performed and compared to that of two clinically validated HPV tests: a RealTime High-Risk HPV test (RealTime) and a Hybrid Capture 2 HPV test (HC2). High agreement for HR-HPV was observed between the Papilloplex and LA and Optiplex HPV tests (97 and 95%, respectively), with kappa values for HPV16 and HPV18 being 0.90 and 0.81 compared to the LA and 0.70 and 0.82 compared to the Optiplex test. The sensitivity, specificity, positive predictive value, and negative predictive value of the Papilloplex test for the detection of CIN2+ were 92, 54, 33, and 96%, respectively, and very similar to the values observed with RealTime and HC2. The Papilloplex HR-HPV test demonstrated a analytical performance similar to those of the two HPV genotyping tests at the HR-HPV level and the type-specific level. The preliminary data on clinical performance look encouraging, although further longitudinal studies within screening populations are required to confirm these findings. PMID:29237790

A novel 3D human glioblastoma cell culture system for modeling drug and radiation responses

PubMed Central

Stevenson, Katrina; Gilmour, Lesley; Hamilton, Graham; Chalmers, Anthony J

2017-01-01

Abstract Background. Glioblastoma (GBM) is the most common primary brain tumor, with dismal prognosis. The failure of drug–radiation combinations with promising preclinical data to translate into effective clinical treatments may relate to the use of simplified 2-dimensional in vitro GBM cultures. Methods. We developed a customized 3D GBM culture system based on a polystyrene scaffold (Alvetex) that recapitulates key histological features of GBM and compared it with conventional 2D cultures with respect to their response to radiation and to molecular targeted agents for which clinical data are available. Results. In 3 patient-derived GBM lines, no difference in radiation sensitivity was observed between 2D and 3D cultures, as measured by clonogenic survival. Three different molecular targeted agents, for which robust clinical data are available were evaluated in 2D and 3D conditions: (i) temozolomide, which improves overall survival and is standard of care for GBM, exhibited statistically significant effects on clonogenic survival in both patient-derived cell lines when evaluated in the 3D model compared with only one cell line in 2D cells; (ii) bevacizumab, which has been shown to increase progression-free survival when added to standard chemoradiation in phase III clinical trials, exhibited marked radiosensitizing activity in our 3D model but had no effect on 2D cells; and (iii) erlotinib, which had no efficacy in clinical trials, displayed no activity in our 3D GBM model, but radiosensitized 2D cells. Conclusions. Our 3D model reliably predicted clinical efficacy, strongly supporting its clinical relevance and potential value in preclinical evaluation of drug–radiation combinations for GBM. PMID:27576873

Comparison of Standardized Clinical Classification with Fundus Photograph Grading for the assessment of Diabetic Retinopathy and Diabetic Macular Edema Severity

PubMed Central

Gangaputra, Sapna; Lovato, James F.; Hubbard, Larry; Davis, Matthew D; Esser, Barbara A; Ambrosius, Walter T.; Chew, Emily Y.; Greven, Craig; Perdue, Letitia H; Wong, Wai T.; Condren, Audree; Wilkinson, Charles P.; Agrón, Elvira; Adler, Sharon; Danis, Ronald P

2013-01-01

Purpose To compare evaluation by clinical examination with image grading at a reading center (RC) for the classification of diabetic retinopathy (DR) and diabetic macular edema (DME). Methods ACCORD and FIND had similar methods of clinical and fundus photograph evaluation. For analysis purposes the photographic grading scales were condensed to correspond to the clinical scales and agreement between clinicians and reading center classification were compared. Results 6902 eyes of ACCORD participants and 3638 eyes of FIND participants were analyzed for agreement (percent, kappa) on DR on a 5 level scale. Exact agreement between clinicians and RC on DR severity category was 69% in ACCORD and 74% in FIND (Kappa 0.42 and 0.65). Sensitivity of the clinical grading to identify presence of mild nonproliferative retinopathy or worse was 0.53 in ACCORD and 0.84 in FIND. Specificities were 0.97 and 0.96, respectively. DME agreement in 6649 eyes of ACCORD participants and 3366 eyes of FIND participants was similar in both studies (Kappa 0.35 and 0.41). Sensitivities of the clinical grading to identify DME were 0.44 and 0.53 and specificities were 0.99 and 0.94, respectively. Conclusion Our results support the use of clinical information for defining broad severity categories, but not for documenting small to moderate changes in DR over time. PMID:23615341

OCT for early quality evaluation of tooth-composite bond in clinical trials.

PubMed

Haak, Rainer; Schmidt, Patrick; Park, Kyung-Jin; Häfer, Matthias; Krause, Felix; Ziebolz, Dirk; Schneider, Hartmut

2018-06-19

To evaluate early quality of composite restorations with a universal adhesive in different application modes clinically and with optical coherence tomography (OCT). 22 patients with four non-carious cervical lesions each received composite restorations (Filtek Supreme TM XTE, 3 M). The universal adhesive Scotchbond Universal TM (SBU, 3 M) was applied with three etching protocols: self-etch (SE), selective-enamel-etch (SEE) and etch-and-rinse (ER). The etch-and-rinse adhesive OptiBond TM FL (OFL, Kerr) served as a control. Restorations were imaged by OCT (Thorlabs) directly after application (t 0 ). After 14 days (t 1 ) and 6 month (t 2 ) OCT imaging (interfacial adhesive defects) was repeated combined with clinical assessment (FDI criteria). Groups were compared by Friedman-/Wilcoxon- and McNemar-Test. No differences were seen clinically between groups (p i ≥ 0.500). OCT assessment revealed more adhesive defects at the enamel interface with SBU/SE at t 0- t 2 compared to all groups (p i ≤ 0.016). OFL showed more defects than SBU/ER (t 1 : p = 0.01; t 2 : p = 0.083). At dentin/cementum interface OFL exhibited more adhesive defects than SBU with all conditioning modes (t 0 , t 1 , p i ≤ 0.003) and at t 2 to SBU/SE and SBU/ER (p < 0.001). Since t 1 defects with SBU were detected more frequently in the SE and SEE modes compared to ER (p i ≤ 0.037). In contrast to SBU defects increased with OFL up to t 2 (p i ≤ 0.007). In contrast to clinical evaluation, OCT revealed subtle adhesive defects directly after application that might interfere with clinical success. It was demonstrated that ER doesn't decrease initial adhesion of SBU to dentin. Copyright © 2018. Published by Elsevier Ltd.

Repair of dimethacrylate-based composite restorations by a silorane-based composite: a one-year randomized clinical trial.

PubMed

Popoff, D A V; Santa Rosa, T T A; Ferreira, R C; Magalhães, C S; Moreira, A N; Mjör, I A

2012-01-01

To investigate clinical performance of a low-shrinkage silorane-based composite resin when used for repairing conventional dimethacrylate-based composite restorations. Despite the continued development of resin-based materials, polymerization shrinkage and shrinkage stress still require improvement. A silorane-based monomer system was recently made available for dental restorations. This report refers to the use of this material for making repairs and evaluates the clinical performance of this alternative treatment. One operator repaired the defective dimethacrylate-based composite resin restorations that were randomly assigned to one of two treatment groups: control (n=50) repair with Adper SE Plus (3M/ESPE) and Filtek P60 Posterior Restorative (3M/ESPE), and test (n=50) repair with P90 System Adhesive Self-Etch Primer and Bond (3M/ESPE) and Filtek P90 Low Shrink Posterior Restorative (3M/ESPE). After one week, restorations were finished and polished. Two calibrated examiners (Kw≥0.78) evaluated all repaired restorations, blindly and independently, at baseline and one year. The parameters examined were marginal adaptation, anatomic form, surface roughness, marginal discoloration, postoperative sensitivity, and secondary caries. The restorations were classified as Alpha, Bravo, or Charlie, according to modified US Public Health Service criteria. Mann-Whitney and Wilcoxon tests were used to compare the groups. Of the 100 restorations repaired in this study, 93 were reexamined at baseline. Dropout from baseline to one-year recall was 11%. No statistically significant differences were found between the materials for all clinical criteria, at baseline or at one-year recall (p>0.05). No statistically significant differences were registered (p>0.05) for each material when compared for all clinical criteria at baseline and at one-year recall. The hypothesis tested in this randomized controlled clinical trial was accepted. After the one-year evaluations, the silorane-based composite exhibited a similar performance compared with dimethacrylate-based composite when used to make repairs.

Access to orphan drugs despite poor quality of clinical evidence

PubMed Central

Dupont, Alain G; Van Wilder, Philippe B

2011-01-01

AIM We analysed the Belgian reimbursement decisions of orphan drugs as compared with those of innovative drugs for more common but equally severe diseases, with special emphasis on the quality of clinical evidence. METHODS Using the National Health Insurance Agency administrative database, we evaluated all submitted orphan drug files between 2002 and 2007. A quality analysis of the clinical evidence in the orphan reimbursement files was performed. The evaluation reports of the French ‘Haute Autorité de Santé’, including the five-point scale parameter ‘Service Médical Rendu (SMR), were examined to compare disease severity. Chi-squared tests (at P < 0.05 significance level) were used to compare the outcome of the reimbursement decisions between orphan and non-orphan innovative medicines. RESULTS Twenty-five files of orphan drugs and 117 files of non-orphan drugs were evaluated. Twenty-two of 25 (88%) submissions of orphan drugs were granted reimbursement as opposed to 74 of the 117 (63%) non-orphan innovative medicines (P = 0.02). Only 52% of the 25 orphan drug files included a randomized controlled trial as opposed to 84% in a random control sample of 25 non-orphan innovative submissions (P < 0.01). The duration of drug exposure was in most cases far too short in relation to the natural history of the disease. CONCLUSIONS Orphan drug designation predicts reimbursement despite poor quality of clinical evidence. The evidence gap at market authorization should be reduced by post-marketing programmes, in which the centralized regulatory and the local reimbursement authorities collaborate in an efficient way across the European Union member states. PMID:21395641

Dedicated dental volumetric and total body multislice computed tomography: a comparison of image quality and radiation dose

NASA Astrophysics Data System (ADS)

Strocchi, Sabina; Colli, Vittoria; Novario, Raffaele; Carrafiello, Gianpaolo; Giorgianni, Andrea; Macchi, Aldo; Fugazzola, Carlo; Conte, Leopoldo

2007-03-01

Aim of this work is to compare the performances of a Xoran Technologies i-CAT Cone Beam CT for dental applications with those of a standard total body multislice CT (Toshiba Aquilion 64 multislice) used for dental examinations. Image quality and doses to patients have been compared for the three main i-CAT protocols, the Toshiba standard protocol and a Toshiba modified protocol. Images of two phantoms have been acquired: a standard CT quality control phantom and an Alderson Rando ® anthropomorphic phantom. Image noise, Signal to Noise Ratio (SNR), Contrast to Noise Ratio (CNR) and geometric accuracy have been considered. Clinical image quality was assessed. Effective dose and doses to main head and neck organs were evaluated by means of thermo-luminescent dosimeters (TLD-100) placed in the anthropomorphic phantom. A Quality Index (QI), defined as the ratio of squared CNR to effective dose, has been evaluated. The evaluated effective doses range from 0.06 mSv (i-CAT 10 s protocol) to 2.37 mSv (Toshiba standard protocol). The Toshiba modified protocol (halved tube current, higher pitch value) imparts lower effective dose (0.99 mSv). The conventional CT device provides lower image noise and better SNR, but clinical effectiveness similar to that of dedicated dental CT (comparable CNR and clinical judgment). Consequently, QI values are much higher for this second CT scanner. No geometric distortion has been observed with both devices. As a conclusion, dental volumetric CT supplies adequate image quality to clinical purposes, at doses that are really lower than those imparted by a conventional CT device.

Shear-wave elastography quantitative assessment of the male breast: added value to distinguish benign and malignant palpable masses.

PubMed

Crombé, Amandine; Hurtevent-Labrot, Gabrielle; Asad-Syed, Maryam; Palussière, Jean; MacGrogan, Gaetan; Kind, Michèle; Ferron, Stéphane

2018-02-01

To evaluate the ability of shear-wave elastography (SWE) to distinguish between benign and malignant palpable masses of the adult male breast. Clinical examination, mammography, B-mode and Doppler ultrasound findings and SWE quantitative parameters were compared in 50 benign lesions (including 40 gynaecomastias) and 15 malignant lesions (invasive ductal carcinomas) from 65 patients who were consecutively addressed for specialized advice at our comprehensive cancer centre. Mean elasticity (El mean), maximum elasticity (El max), El mean of the surrounding fatty tissue and lesion to fat ratio (El ratio) were reported for each patient. Malignant masses displayed significantly higher El mean (p < 0.0001), El max (p < 0.0001) and El ratio (p < 0.0001) compared to benign masses without overlap of values between the two groups. By adding SWE to clinical examination, mammography and ultrasound, all the lesions would have been retrospectively correctly diagnosed as benign or malignant. One false positive could have been downstaged, 14/65 undetermined masses could have been correctly reclassified as 4 malignant and 10 benign lesions, for which biopsies could have consequently been avoided. Evaluation of male breast palpable masses by SWE demonstrates that malignant masses are significantly stiffer lesions and may improve diagnostic management when clinical examination, mammography and conventional ultrasound are doubtful. Advances in knowledge: Quantitative SWE is feasible in male breast and could be of great interest to help classify doubtful lesions after classical clinical and radiological evaluations, probably because of different anatomy and different tumours epidemiology compared with female breast.

Clinical performance of a glass ionomer restorative system: a 6-year evaluation.

PubMed

Gurgan, Sevil; Kutuk, Zeynep Bilge; Ergin, Esra; Oztas, Sema Seval; Cakir, Filiz Yalcin

2017-09-01

The aim of this study is to evaluate the long-term clinical performance of a glass ionomer (GI) restorative system in the restoration of posterior teeth compared with a micro-filled hybrid posterior composite. A total of 140 (80 Cl1 and 60 Cl2) lesions in 59 patients were restored with a GI system (Equia) or a micro hybrid composite (Gradia Direct). Restorations were evaluated at baseline and yearly during 6 years according to the modified-USPHS criteria. Negative replicas at each recall were observed under SEM to evaluate surface characteristics. Data were analyzed with Cohcran's Q and McNemar's tests (p < 0.05). One hundred fifteen (70 Cl1 and 45 Cl2) restorations were evaluated in 47 patients with a recall rate of 79.6% at 6 years. Significant differences were found in marginal adaptation and marginal discoloration for both restorative materials for Cl1 and Cl2 restorations (p < 0.05). However, none of the materials were superior to the other (p > 0.05). A significant decrease in color match was observed in Equia restorations (p < 0.05). Only one Cl2 Equia restoration was missing at 3 years and another one at 4 years. No failures were observed at 5 and 6 years. Both materials exhibited clinically successful performance after 6 years. SEM evaluations were in accordance with the clinical findings. Both materials showed a good clinical performance for the restoration of posterior teeth during the 6-year evaluation. The clinical effectiveness of Equia and Gradia Direct Posterior was acceptable in Cl1 and Cl2 cavities subsequent to 6-year evaluation.

Kinematic measures for upper limb motor assessment during robot-mediated training in patients with severe sub-acute stroke.

PubMed

Duret, Christophe; Courtial, Ophélie; Grosmaire, Anne Gaelle

2016-01-01

Kinematic assessments are increasingly used as motor outcome measures during upper limb robot-assisted training, in addition to clinical scales. However, their relevance has not been evaluated much. Thirty-eight patients with severe sub-acute stroke (age 56 ± 17 [19-87] years; time since stroke, 55 ± 22 days) carried out 16 sessions (average 3/week, 35 ± 15 days) of upper limb robot-assisted training combined with standard therapy. Pre/post motor performance was evaluated using the Fugl-Meyer Assessment scale, Motor Status Scale (MSS) and kinematic measures. Motor outcomes were compared and relationships between clinical and kinematic outcomes were analyzed. All clinical and kinematic outcomes improved after training (p <  0.01). FM score increased from 17.7 ± 10.0 to 28.6 ± 15.4. All baseline kinematic measures were strongly correlated with clinical scores. Correlations between clinical and kinematic changes were moderate (r = -0.65 for change in FM Proximal score and change in accuracy measure). However, smoothness and accuracy indicators were shown to be responsive measures. This study demonstrated that baseline kinematic measures and their pre/post training changes were significantly correlated with clinical motor outcome measures. However, even if kinematic measures are valid for the evaluation of motor impairment we cannot propose to substitute common clinical measures of motor function which also evaluate functional abilities of the upper limb.

Impact of the site specialty of a continuity practice on students' clinical skills: performance with standardized patients.

PubMed

Pfeiffer, Carol A; Palley, Jane E; Harrington, Karen L

2010-07-01

The assessment of clinical competence and the impact of training in ambulatory settings are two issues of importance in the evaluation of medical student performance. This study compares the clinical skills performance of students placed in three types of community preceptors' offices (pediatrics, medicine, family medicine) on yearly clinical skills assessments with standardized patients. Our goal was to see if the site specialty impacted on clinical performance. The students in the study were completing a 3-year continuity preceptorship at a site representing one of the disciplines. Their performance on the four clinical skills assessments was compared. There was no significant difference in history taking, physical exam, communication, or clinical reasoning in any year (ANOVA p< or = .05) There was a small but significant difference in performance on a measure of interpersonal and interviewing skills during Years 1 and 2. The site specialty of an early clinical experience does not have a significant impact on performance of most of the skills measured by the assessments.

Heat-cured acrylic resin versus light-activated resin: a patient, professional and technician-based evaluation of mandibular implant-supported overdentures.

PubMed

Asal, S A; Al-AlShiekh, H M

2017-12-01

Although light-activated resins (Eclipse) have been reported to possess superior physical and mechanical properties compared with the heat-cured acrylic resins (Lucitone-199), a few studies have compared overdentures with a locator attachment constructed from heat-cured acrylic resins with those constructed from light-activated resins. This clinical study was designed to compare the performance of a mandibular implant-supported overdenture constructed from a heat-cured acrylic resin (Lucitone-199) with that of an overdenture constructed from a light-activated resin (Eclipse). Ten participants received two identical mandibular implant-retained overdentures (Lucitone-199 and Eclipse) opposing one maxillary denture in a random order. Each mandibular overdenture was delivered and worn for 6 months, and two weeks of rest was advised between wears to minimize any carryover effects. Three questionnaires were devised. The first questionnaire (patient evaluation) focused on evaluating different aspects of the denture and overall satisfaction. The second questionnaire (professional dentist evaluation) was based on a clinical evaluation of soft tissues, complications, and the applied technique. The third questionnaire (technician evaluation) involved ranking the different manufacturing steps of the denture and overall preferences. The obtained data was statistically analyzed using an independent sample t-test and the Wilcoxon rank-sum test. The clinician and technician preferred the Eclipse dentures because of their technical aspects, whereas the patients preferred the Lucitone-199 dentures for their aesthetic properties. Implant-supported overdentures constructed from a heat-cured acrylic resin showed superior aesthetics and had a better odor compared with those constructed from a light-cured resin.

SPIDERplan: A tool to support decision-making in radiation therapy treatment plan assessment.

PubMed

Ventura, Tiago; Lopes, Maria do Carmo; Ferreira, Brigida Costa; Khouri, Leila

2016-01-01

In this work, a graphical method for radiotherapy treatment plan assessment and comparison, named SPIDERplan, is proposed. It aims to support plan approval allowing independent and consistent comparisons of different treatment techniques, algorithms or treatment planning systems. Optimized plans from modern radiotherapy are not easy to evaluate and compare because of their inherent multicriterial nature. The clinical decision on the best treatment plan is mostly based on subjective options. SPIDERplan combines a graphical analysis with a scoring index. Customized radar plots based on the categorization of structures into groups and on the determination of individual structures scores are generated. To each group and structure, an angular amplitude is assigned expressing the clinical importance defined by the radiation oncologist. Completing the graphical evaluation, a global plan score, based on the structures score and their clinical weights, is determined. After a necessary clinical validation of the group weights, SPIDERplan efficacy, to compare and rank different plans, was tested through a planning exercise where plans had been generated for a nasal cavity case using different treatment planning systems. SPIDERplan method was applied to the dose metrics achieved by the nasal cavity test plans. The generated diagrams and scores successfully ranked the plans according to the prescribed dose objectives and constraints and the radiation oncologist priorities, after a necessary clinical validation process. SPIDERplan enables a fast and consistent evaluation of plan quality considering all targets and organs at risk.

Portable handheld diffuse reflectance spectroscopy system for clinical evaluation of skin: a pilot study in psoriasis patients

PubMed Central

Tzeng, Shih-Yu; Guo, Jean-Yan; Yang, Chao-Chun; Hsu, Chao-Kai; Huang, Hung Ji; Chou, Shih-Jie; Hwang, Chi-Hung; Tseng, Sheng-Hao

2016-01-01

Diffuse reflectance spectroscopy (DRS) has been utilized to study biological tissues for a variety of applications. However, many DRS systems are not designed for handheld use and/or relatively expensive which limit the extensive clinical use of this technique. In this paper, we report a handheld, low-cost DRS system consisting of a light source, optical switch, and a spectrometer, that can precisely quantify the optical properties of tissue samples in the clinical setting. The handheld DRS system was employed to determine the skin chromophore concentrations, absorption and scattering properties of 11 patients with psoriasis. The measurement results were compared to the clinical severity of psoriasis as evaluated by dermatologist using PASI (Psoriasis Area and Severity Index) scores. Our statistical analyses indicated that the handheld DRS system could be a useful non-invasive tool for objective evaluation of the severity of psoriasis. It is expected that the handheld system can be used for the objective evaluation and monitoring of various skin diseases such as keloid and psoriasis. PMID:26977366

A Comparison of Four Simulation and Instructional Methods for Endodontic Review.

ERIC Educational Resources Information Center

Sandoval, Victor A.; And Others

1987-01-01

The effects of four different endodontic self-instructional review formats (slide-tape, latent-image simulation, computer text simulation, and computer-assisted video interactive simulation) on senior clinical endodontic performance are compared. Student evaluations, as well as comparative developmental expenditures, are discussed. (Author/MLW)

Psychometric evaluation of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales.

PubMed

McCaffrey, Stacey A; Black, Ryan A; Butler, Stephen F

2018-03-01

The PainCAS is a web-based clinical tool for assessing and tracking pain and opioid risk in chronic pain patients. Despite evidence for its utility within the clinical setting, the PainCAS scales have never been subject to psychometric evaluation. The current study is the first to evaluate the psychometric properties of the PainCAS Interference with Daily Activities, Psychological/Emotional Distress, and Pain scales. Patients (N = 4797) from treatment centers and hospitals in 16 different states completed the PainCAS as part of routine clinical assessment. A subsample (n = 73) from two hospital-based treatment centers also completed comparator measures. Rasch Rating Scale Models were employed to evaluate the Interference with Daily Activities and Psychological/Emotional Distress scales, and empirical evaluation included assessment of dimensionality, discrimination, item fit, reliability, information, and person-to-item targeting. Additionally, convergent and discriminant validity were evaluated through classical test theory approaches. Convergent validity of the Pain scales was evaluated through correlations with corresponding comparator items. One Interference with Daily Activities item was removed due to poor functioning and discrimination. The retained items from the Interference with Daily Activities and Psychological/Emotional Distress scales conformed to unidimensional Rasch measurement models, yielding satisfactory item fit, reliability, precision, and coverage. Further, results provided support for the convergent and discriminant validity of these two scales. Convergent validity between the PainCAS Pain and BPI Pain items was also strong. Taken together, results provide strong psychometric support for these PainCAS Pain scales. Strengths and limitations of the current study are discussed.

A comparative study for image quality and radiation dose of a cone beam computed tomography scanner and a multislice computed tomography scanner for paranasal sinus imaging.

PubMed

De Cock, Jens; Zanca, Federica; Canning, John; Pauwels, Ruben; Hermans, Robert

2015-07-01

To evaluate image quality and radiation dose of a state of the art cone beam computed tomography (CBCT) system and a multislice computed tomography (MSCT) system in patients with sinonasal poliposis. In this retrospective study two radiologists evaluated 57 patients with sinonasal poliposis who underwent a CBCT or MSCT sinus examination, along with a control group of 90 patients with normal radiological findings. Tissue doses were measured using a phantom model with thermoluminescent dosimeters (TLD). Overall image quality in CBCT was scored significantly higher than in MSCT in patients with normal radiologic findings (p-value: 0.00001). In patients with sinonasal poliposis, MSCT scored significantly higher than CBCT (p-value: 0.00001). The average effective dose for MSCT was 42% higher compared to CBCT (108 μSv vs 63 μSv). CBCT and MSCT are both suited for the evaluation of sinonasal poliposis. In patients with sinonasal poliposis, clinically important structures of the paranasal sinuses can be better delineated with MSCT, whereas in patients without sinonasal poliposis, CBCT turns out to define the important structures of the sinonasal region better. However, given the lower radiation dose, CBCT can be considered for the evaluation of the sinonasal structures in patients with sinonasal poliposis. • CBCT and MSCT are both suited for evaluation of sinonasal poliposis. • Effective dose for MSCT was 42% higher compared to CBCT. • In patients with sinonasal poliposis, clinically important anatomical structures are better delineated with MSCT. • In patients with normal radiological findings, clinically important anatomical structures are better delineated with CBCT.

Neuropsychological and clinical heterogeneity of cognitive impairment in patients with multiple system atrophy.

PubMed

Barcelos, Lorena Broseghini; Saad, Flávia; Giacominelli, Carla; Saba, Roberta Arb; de Carvalho Aguiar, Patrícia Maria; Silva, Sonia Maria Azevedo; Borges, Vanderci; Bertolucci, Paulo Henrique Ferreira; Ferraz, Henrique Ballalai

2018-01-01

We evaluated neuropsychological tests to compare cognitive impairment between two types of multiple system atrophy: predominant parkinsonism (MSA-P) and predominant cerebellar ataxia (MSA-C). This cross-sectional study included 14 patients diagnosed with MSA: four with MSA-C and ten with MSA-P. Presence of motor symptoms was determined by using the Unified Rating MSA Scale (URMSAS). Non-motor symptoms were evaluated by the Short Form Health Survey (SF-36), Scales for Outcomes in Parkinson's disease Autonomic (SCOPA-AUT), Hospital Anxiety and Depression Scale (HADS), and Beck Depression Inventory (BDI). Neuropsychological tests were used to evaluate general cognition, verbal and visual memory, working memory, constructional ability, visuospatial, language, and executive function. The median age of the patients was 62 years, median disease duration was 3.5 years, and median education level was 10 years. The median Mini-Mental State Examination (MMSE) score was 26.5 points, and median Mattis Dementia Rating Scale (MDRS) score was 131.5. We compared the continuous data between the two MSA subtypes and observed that bodily pain reported in the quality of life questionnaire, SF-36, was worse in MSA-P (p<0.05), and attention function evaluated by MDRS was significantly lower in MSA-C than MSA-P (p<0.05). Our comparative study of cognitive impairment in MSA-P and MSA-C showed that both groups had impaired executive and visuospatial functions, while the attention deficit was predominant only in MSA-C. These findings support the concept that cognitive deficit originates from striatofrontal dysfunction and cerebellar degeneration. Our study also suggests that cognitive impairment is relevant in MSA, and clinical neurologists should not neglect evaluation of these aspects in their daily clinical practice. Copyright © 2017. Published by Elsevier B.V.

Evaluation and comparison of current fetal ultrasound image segmentation methods for biometric measurements: a grand challenge.

PubMed

Rueda, Sylvia; Fathima, Sana; Knight, Caroline L; Yaqub, Mohammad; Papageorghiou, Aris T; Rahmatullah, Bahbibi; Foi, Alessandro; Maggioni, Matteo; Pepe, Antonietta; Tohka, Jussi; Stebbing, Richard V; McManigle, John E; Ciurte, Anca; Bresson, Xavier; Cuadra, Meritxell Bach; Sun, Changming; Ponomarev, Gennady V; Gelfand, Mikhail S; Kazanov, Marat D; Wang, Ching-Wei; Chen, Hsiang-Chou; Peng, Chun-Wei; Hung, Chu-Mei; Noble, J Alison

2014-04-01

This paper presents the evaluation results of the methods submitted to Challenge US: Biometric Measurements from Fetal Ultrasound Images, a segmentation challenge held at the IEEE International Symposium on Biomedical Imaging 2012. The challenge was set to compare and evaluate current fetal ultrasound image segmentation methods. It consisted of automatically segmenting fetal anatomical structures to measure standard obstetric biometric parameters, from 2D fetal ultrasound images taken on fetuses at different gestational ages (21 weeks, 28 weeks, and 33 weeks) and with varying image quality to reflect data encountered in real clinical environments. Four independent sub-challenges were proposed, according to the objects of interest measured in clinical practice: abdomen, head, femur, and whole fetus. Five teams participated in the head sub-challenge and two teams in the femur sub-challenge, including one team who tackled both. Nobody attempted the abdomen and whole fetus sub-challenges. The challenge goals were two-fold and the participants were asked to submit the segmentation results as well as the measurements derived from the segmented objects. Extensive quantitative (region-based, distance-based, and Bland-Altman measurements) and qualitative evaluation was performed to compare the results from a representative selection of current methods submitted to the challenge. Several experts (three for the head sub-challenge and two for the femur sub-challenge), with different degrees of expertise, manually delineated the objects of interest to define the ground truth used within the evaluation framework. For the head sub-challenge, several groups produced results that could be potentially used in clinical settings, with comparable performance to manual delineations. The femur sub-challenge had inferior performance to the head sub-challenge due to the fact that it is a harder segmentation problem and that the techniques presented relied more on the femur's appearance.

Peer group reflection helps clinical teachers to critically reflect on their teaching.

PubMed

Boerboom, Tobias B B; Jaarsma, Debbie; Dolmans, Diana H J M; Scherpbier, Albert J J A; Mastenbroek, Nicole J J M; Van Beukelen, Peter

2011-01-01

Student evaluations can help clinical teachers to reflect on their teaching skills and find ways to improve their teaching. Studies have shown that the mere presentation of student evaluations is not a sufficient incentive for teachers to critically reflect on their teaching. We evaluated and compared the effectiveness of two feedback facilitation strategies that were identical except for a peer reflection meeting. In this study, 54 clinical teachers were randomly assigned to two feedback strategies. In one strategy, a peer reflection was added as an additional step. All teachers completed a questionnaire evaluating the strategy that they had experienced. We analysed the reflection reports and the evaluation questionnaire. Both strategies stimulated teachers to reflect on feedback and formulate alternative actions for their teaching practice. The teachers who had participated in the peer reflection meeting showed deeper critical reflection and more concrete plans to change their teaching. All feedback strategies were considered effective by the majority of the teachers. Strategies with student feedback and self-assessment stimulated reflection on teaching and helped clinical teachers to formulate plans for improvement. A peer reflection meeting seemed to enhance reflection quality. Further research should establish whether it can have lasting effects on teaching quality.

[Dosimetric comparing between protons beam and photons beam
for lung cancer radiotherapy: a meta-analysis].

PubMed

Tian, Guangwei; Li, Nan; Li, Guang

2013-05-01

The clinical evidences are not sufficient on the proton beam therapy of lung cancer for lacking of the RCTs on the comparing the proton with the photon beam in lung cancer radiotherapy. The aim of this study is to evaluate the dosimetry superiority of the proton beam and provide more valuable evidences to the clinical researches. Clinical trails of dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy were obtained from the Cochrane library, Pubmed, EMbase, CBM, CNKI, VIP, and Wan Fang databases. The data included in the study were evaluated and analyzed using the Cochrane Collaboration's RevMan 5.2 software. Six trails were included. Compared to photon therapy (three-dimensional conformal photon radiotherapy, 3D-CRT), the proton therapy had a significantly lower total lung Dmean (MD=-4.15, 95%CI: -5.56--2.74, P<0.001) and V20, V10, V5 (MD=-10.92, 95%CI: -13.23--8.62, P<0.001); The V20, V10, V5 significantly decreased in proton therapy group. Compared to photon therapy (intensity-modulated photon radiotherapy, IMRT), V20, V10, V5 were also significantly lowered in proton therapy group (MD=-3.70, 95%CI: -5.31--2.10, P<0.001; MD=-8.86, 95%CI: -10.74--6.98, P<0.001; MD=-20.13, 95%CI: -27.11--13.14, P<0.001); The esophagus Dmean was not lowered, while the heart Dmean decreased in proton therapy group. Comparing to photon beam radiotherapy (3D-CRT and IMRT), proton beam therapy is advantageous in dosimetry of the lung cancer radiotherapy and recommended for clinical applying.

Stroke prevention in atrial fibrillation: re-defining 'real-world data' within the broader data universe.

PubMed

Fanaroff, Alexander C; Steffel, Jan; Alexander, John H; Lip, Gregory Y H; Califf, Robert M; Lopes, Renato D

2018-04-23

Real-world data (RWD) has been defined as data generated outside of traditional randomized clinical trials (RCTs). Though RWD has received increasing attention from regulatory authorities and professional societies, dividing evidence into that derived from 'real-world' vs. 'non-real-world' sources provides only one element of a much larger framework for evidence evaluation. Evidence should be evaluated on the source of the data, the method of treatment allocation (whether any intervention being evaluated was assigned or simply observed as used in practice) and the context in which the evidence was generated (overall study design). Under this framework, RWD refers only to data source, and a study incorporates RWD when it primarily uses data collected for non-research purposes, such as insurance claims data or the electronic health record, regardless of study design. Separation of study design, data source, and context enables parallel evaluation of two critical elements: (i) whether a study can support claims of causal inference, which can be assured with a high degree of confidence only in studies where patients are assigned treatments by protocol; and (ii) whether the study population and clinical context mirror clinical practice, a strength of observational studies using data from clinical practice or administrative claims. In this review, we describe the strengths and weaknesses of observational and non-observational studies, and studies involving RWD and non-RWD, through the lens of anticoagulation for atrial fibrillation (AF). Observational studies employing RWD are useful for describing how oral anticoagulants are used in clinical practice, but generally cannot be used to make claims regarding comparative treatment effects. Questions regarding treatment effect generally are best answered through an RCT, and additional pragmatic RCTs are needed to compare different antithrombotic agents for the prevention of thrombotic events in AF.

Evaluation of the breeding soundness of male camels (Camelus dromedarius) via clinical examination, semen analysis, ultrasonography and testicular biopsy: a summary of 80 clinical cases.

PubMed

Waheed, M M; Ghoneim, I M; Hassieb, M M; Alsumait, A A

2014-10-01

Male camel infertility is a heterogeneous disorder. A variety of factors may adversely affect sperm production and function and impair fertility. This study was designed to evaluate the sensitivity and specificity of ultrasonography and testicular biopsy in the evaluation of the breeding soundness of male dromedaries compared with results obtained by clinical examination and semen analysis. Eighty-four male dromedary camels (5-15 years old) were used in this study during the rutting season (November-May). Four sexually mature male camels were used as controls. These animals were apparently healthy and had histories of normal fertility. Eighty infertile male camels were subjected to an algorithmic approach based on information collected during careful examinations of the camels' breeding histories, clinical examinations, testicular evaluations, testicular ultrasonographies, the results of the semen analyses and testicular biopsies to diagnose the camels' infertilities. The differences in the semen parameters between the control and infertile male camels were highly significant (p < 0.01). Regarding the diagnoses of male camel infertility, the results of testicular ultrasonographies and biopsies were compared with those from the semen analyses, and the accuracies of these tests were 92.5% and 90%, respectively. Additionally, the results of the testicular ultrasonographies were matched with those of the testicular biopsies of the infertile animals, and this comparison resulted in 85% accuracy. Testicular biopsy is a promising method that, along with a carefully performed history, clinical examination, an appropriate testicular ultrasonography procedure and semen analysis, can afford veterinarians the opportunity for more precise diagnosis and treatment of many dromedary infertility disorders. © 2014 Blackwell Verlag GmbH.

[Correlation of clinical and radiologic results of complete subtalar release in congenital clubfoot].

PubMed

Kalenderer, Onder; Ağuş, Haluk; Ak, Mümtaz; Ozlük, Serkan

2003-01-01

We evaluated the mid-term results in patients who underwent complete subtalar release with the use of the Cincinnati incision for congenital clubfoot. Complete subtalar release was performed in 30 feet of 23 patients (16 boys, 7 girls; 7 bilateral cases). The mean age at surgery was 17.5 months (range 2 to 84 months). Clinically, cosmetic appearance, adduction of the forefoot, the range of motion of the ankle joint, and muscle strength were evaluated. Radiologic evaluations included talocalcaneal angles on antero-posterior and lateral views, talocalcaneal index, talar-first metatarsal angles, calcaneal-fifth metatarsal angles, and Bohler angles. Talar and navicular bone lengths were compared with the other side in unilateral patients. The results were evaluated according to the Simons' criteria. The mean follow-up was 9 years and 8 months (range 7 years to 14 years). The mean range of motion of the ankle joint was measured as 47 degrees (range 10 degrees to 60 degrees ). The parents of three patients were not satisfied with the clinical results. Clinically, six patients had metatarsus adductus. Radiologically, flattening of the talar head (7 patients) and the talar dome (2 patients) were detected in unilateral patients. Navicular dorsal subluxation was found in seven feet. Compared to the normal side, the mean navicular shortening was 2.6 mm (range 0 to 4 mm), the mean talar shortening was 4.8 mm (range 2 to 11 mm). According to the Simons' criteria, the results were satisfactory in 27 feet (90%) and unsatisfactory in three feet (10%). Our results suggest that complete subtalar release for the treatment of clubfoot enables correction of all components of the deformity at a single session, and that its clinical results are more favorable than radiologic results, without requiring a close cooperation of the parents.

[Comparative evaluation of clinical practice guidelines for the treatment of schizophrenia].

PubMed

Delessert, D; Pomini, V; Grasset, F; Baumann, P

2008-01-01

Many clinical practice guidelines (CPG) have been published in reply to the development of the concept of "evidence-based medicine" (EBM) and as a solution to the difficulty of synthesizing and selecting relevant medical literature. Taking into account the expansion of new CPG, the question of choice arises: which CPG to consider in a given clinical situation? It is of primary importance to evaluate the quality of the CPG, but until recently, there has been no standardized tool of evaluation or comparison of the quality of the CPG. An instrument of evaluation of the quality of the CPG, called "AGREE" for appraisal of guidelines for research and evaluation was validated in 2002. The six principal CPG concerning the treatment of schizophrenia are compared with the help of the "AGREE" instrument: (1) "the Agence nationale pour le développement de l'évaluation médicale (ANDEM) recommendations"; (2) "The American Psychiatric Association (APA) practice guideline for the treatment of patients with schizophrenia"; (3) "The quick reference guide of APA practice guideline for the treatment of patients with schizophrenia"; (4) "The schizophrenia patient outcomes research team (PORT) treatment recommendations"; (5) "The Texas medication algorithm project (T-MAP)" and (6) "The expert consensus guideline for the treatment of schizophrenia". The results of our study were then compared with those of a similar investigation published in 2005, structured on 24 CPG tackling the treatment of schizophrenia. The "AGREE" tool was also used by two investigators in their study. In general, the scores of the two studies differed little and the two global evaluations of the CPG converged; however, each of the six CPG is perfectible. The rigour of elaboration of the six CPG was in general average. The consideration of the opinion of potential users was incomplete, and an effort made in the presentation of the recommendations would facilitate their clinical use. Moreover, there was little consideration by the authors regarding the applicability of the recommendations. Globally, two CPG are considered as strongly recommended: "the quick reference guide of the APA practice guideline for the treatment of patients with schizophrenia" and "the T-MAP".

Differential effects on socioeconomic groups of modelling the location of mammography screening clinics using Geographic Information Systems.

PubMed

Hyndman, J C; Holman, C D

2000-06-01

To evaluate spatial access to mammography clinics and to investigate whether relocating clinics can improve global access. To determine whether any change in access is distributed equitably between different social groups. The study was undertaken in Perth, Western Australia in 1996. It was an analysis of travel distances to mammography clinics, comparing distances to the pattern of existing clinics and modelled relocated clinics. The study population was the 151,162 women aged 40-64 years resident in Perth in 1991. Overall travel distances to the existing clinics was reduced by 14% when a GIS system was used to relocate them so as to minimise the travel distance for all women. The travel distance of the most disadvantaged groups fell by 2% and by 24% for the least disadvantaged group. GIS modelling can be used to advantage to evaluate potential locations for screening clinics that improve the access for the target population, however global analysis should be supplemented by analysis of special groups to ensure that no group is disadvantaged by the proposal. If new technology is not used to evaluate the placement of health services, population travel distances may be greater than necessary, with possible impacts on attendance rates.

Nonmydriatic fundus photography for teleophthalmology diabetic retinopathy screening in rural and urban clinics.

PubMed

Chin, Eric K; Ventura, Bruna V; See, Kai-Yin; Seibles, Joann; Park, Susanna S

2014-02-01

To evaluate the relative diagnostic value of nonmydriatic fundus photography (nFP) among patients screened for diabetic retinopathy in remote rural medical clinics and an urban academic medical center for nonadherence to recommended annual dilated eye examination. A retrospective cross-sectional study was performed among diabetic patients seen in primary outpatient clinics between 2006 and 2011 who were screened for diabetic retinopathy with nFP for history of nonadherence to recommended annual dilated eye examination. A single nonstereoscopic, 45°, 10-megapixel digital image of the disc and macula of both eyes was obtained locally and transmitted electronically to a retinal specialist for remote review. The results from remote rural Native American Indian reservations were compared with those from an urban academic family practice clinic. The proportion of subjects diagnosed with diabetic retinopathy and the quality of fundus images were compared. Among 872 patients (1,744 eyes) screened from rural sites and 517 subjects (1,034 eyes) screened from an urban site, images were of good quality for evaluation in 82.4% and 85.7% of subjects, respectively. Diabetic retinopathy was noted in 12.6% of rural subjects and 29.6% of urban subjects (p<0.001). nFP can be a useful tool in both rural and urban settings to screen for diabetic retinopathy in patients who are nonadherent to the recommended dilated annual eye exam. In our study population, a surprisingly higher percentage of diabetic subjects screened from the urban clinic had retinopathy compared with subjects screened in rural clinics.

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation.

PubMed

Rafati, Mr; Karami, H; Salehifar, E; Karimzadeh, A

2011-01-01

Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008-2009. Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2-12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0-1.5 g/kg/day PEG 3350 or 1.0-1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events.

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.

Comparison of low-light nonmydriatic digital imaging with 35-mm ETDRS seven-standard field stereo color fundus photographs and clinical examination.

PubMed

Silva, Paolo S; Walia, Saloni; Cavallerano, Jerry D; Sun, Jennifer K; Dunn, Cheri; Bursell, Sven-Erik; Aiello, Lloyd M; Aiello, Lloyd Paul

2012-09-01

To compare agreement between diagnosis of clinical level of diabetic retinopathy (DR) and diabetic macular edema (DME) derived from nonmydriatic fundus images using a digital camera back optimized for low-flash image capture (MegaVision) compared with standard seven-field Early Treatment Diabetic Retinopathy Study (ETDRS) photographs and dilated clinical examination. Subject comfort and image acquisition time were also evaluated. In total, 126 eyes from 67 subjects with diabetes underwent Joslin Vision Network nonmydriatic retinal imaging. ETDRS photographs were obtained after pupillary dilation, and fundus examination was performed by a retina specialist. There was near-perfect agreement between MegaVision and ETDRS photographs (κ=0.81, 95% confidence interval [CI] 0.73-0.89) for clinical DR severity levels. Substantial agreement was observed with clinical examination (κ=0.71, 95% CI 0.62-0.80). For DME severity level there was near-perfect agreement with ETDRS photographs (κ=0.92, 95% CI 0.87-0.98) and moderate agreement with clinical examination (κ=0.58, 95% CI 0.46-0.71). The wider MegaVision 45° field led to identification of nonproliferative changes in areas not imaged by the 30° field of ETDRS photos. Field area unique to ETDRS photographs identified proliferative changes not visualized with MegaVision. Mean MegaVision acquisition time was 9:52 min. After imaging, 60% of subjects preferred the MegaVision lower flash settings. When evaluated using a rigorous protocol, images captured using a low-light digital camera compared favorably with ETDRS photography and clinical examination for grading level of DR and DME. Furthermore, these data suggest the importance of more extensive peripheral images and suggest that utilization of wide-field retinal imaging may further improve accuracy of DR assessment.

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.

Evaluation of clinical, radiographical and cytological findings compared to arthroscopic findings in shoulder joint lameness in the dog.

PubMed

Akerblom, S; Sjöström, L

2007-01-01

Forty-two dogs with lameness emanating from the shoulder joint were studied by clinical examination, radiographic examination, joint fluid analysis, and arthroscopic examination, following a set protocol. Dogs with mild clinical signs, absent or mild radiographic signs of osteoarthrosis, and without or with very mild changes in the synovial fluid, may still have moderate to severe degenerative pathological changes in the shoulder joint.

Setting high-impact clinical research priorities for the Society for Vascular Surgery.

PubMed

Kraiss, Larry W; Conte, Michael S; Geary, Randolph L; Kibbe, Melina; Ozaki, C Keith

2013-02-01

With the overall goal of enhancing the effectiveness and efficiency of vascular care, the Society for Vascular Surgery (SVS) recently completed a process by which it identified its top clinical research priorities to address critical gaps in knowledge guiding practitioners in prevention and treatment of vascular disease. After a survey of the SVS membership, a panel of SVS committee members and opinion leaders considered 53 distinct research questions through a structured process that resulted in identification of nine clinical issues that were felt to merit immediate attention by vascular investigators and external funding agencies. These are, in order of priority: (1) define optimal management of asymptomatic carotid stenosis, (2) compare the effectiveness of medical vs invasive treatment (open or endovascular) of vasculogenic claudication, (3) compare effectiveness of open vs endovascular infrainguinal revascularization as initial treatment of critical limb ischemia, (4) develop and compare the effectiveness of clinical strategies to reduce cardiovascular and other perioperative complications (eg, wound) after vascular intervention, (5) compare the effectiveness of strategies to enhance arteriovenous fistula maturation and durability, (6) develop best practices for management of chronic venous ulcer, (7) define optimal adjunctive medical therapy to enhance the success of lower extremity revascularization, (8) identify and evaluate medical therapy to prevent abdominal aortic aneurysm growth, and (9) evaluate ultrasound vs computed tomographic angiography surveillance after endovascular aneurysm repair. Copyright © 2013 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Robotic versus laparoscopic proctectomy for rectal cancer: a meta-analysis.

PubMed

Memon, Sameer; Heriot, Alexander G; Murphy, Declan G; Bressel, Mathias; Lynch, A Craig

2012-07-01

Robot-assisted laparoscopic surgery is being performed more frequently for the minimally invasive management of rectal cancer. The objective of this meta-analysis was to compare the clinical and oncologic safety and efficacy of robot-assisted versus conventional laparoscopic surgery. A search of the Medline and Embase databases was performed for studies that compared clinical or oncologic outcomes of conventional laparoscopic proctectomy with robot-assisted laparoscopic proctectomy for rectal cancer. The methodological quality of the selected studies was critically assessed to identify studies suitable for inclusion. Meta-analysis was performed by a random effects model and analyzed by Review Manager. Clinical outcomes evaluated were conversion rates, operation times, length of hospital stay, and complications. Oncologic outcomes evaluated were circumferential margin status, number of lymph nodes collected, and distal resection margin lengths. Eight comparative studies were assessed for quality, and seven studies were included in the meta-analysis. Two studies were matched case-control studies, and five were unmatched. A total of 353 robot-assisted laparoscopic surgery proctectomy cases and 401 conventional laparoscopic surgery proctectomy cases were analyzed. Robotic surgery was associated with a significantly lower conversion rate (P=0.03; 95% confidence interval 1-12). There was no difference in complications, circumferential margin involvement, distal resection margin, lymph node yield, or hospital stay (P=NS). Robot-assisted surgery decreased the conversion rate compared to conventional laparoscopic surgery. Other clinical outcomes and oncologic outcomes were equivalent. The benefits of robotic rectal cancer surgery may differ between population groups.

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.

Levofloxacin 750-mg for 5 days for the treatment of hospitalized Fine Risk Class III/IV community-acquired pneumonia patients.

PubMed

Shorr, Andrew F; Khashab, Mohammed M; Xiang, Jim X; Tennenberg, Alan M; Kahn, James B

2006-12-01

The efficacy and safety of 750-mg, 5-day levofloxacin was recently shown to be comparable to 500-mg, 10-day levofloxacin in a randomized, double-blind, multicentre clinical trial for mild-to-severe community-acquired pneumonia (CAP). This subgroup analysis attempted to compare the safety and efficacy of a short-course levofloxacin regimen with traditional levofloxacin dosing for PSI Class III/IV patients. This retrospective, subgroup analysis focused on Pneumonia Severity Index Class III and IV patients enrolled in the study. Measurements included clinical and microbiological success rates, adverse events, and symptom resolution by day 3 of therapy. Of the 528 patients in the ITT population, 219 (41.5%) were categorized as PSI Class III/IV and included in this analysis. Among the clinically evaluable patients, 90.8% (69/76) of patients treated with the 750-mg regimen achieved clinical success, compared with 85.5% (71/83) treated with 500-mg levofloxacin (95% CI,-15.9 to 5.4). Eradication rates in the microbiologically evaluable population were comparable for the 750- and 500-mg regimens (88.9% vs 87.5%, respectively; 95% CI,-18.3 to 15.6). Both regimens were well tolerated and had comparable safety profiles. A greater proportion of patients in the 750-mg treatment group experienced resolution of fever (48.4% vs 34.0%; P=.046) and purulent sputum (48.4% vs 27.5%; P=.007) by day 3 of therapy. The 750-mg, 5-day levofloxacin course achieved comparable clinical and microbiologic efficacy to the 500-mg, 10-day regimen. By day 3 of therapy, a greater proportion of patients in the 750-mg group had objective and subjective resolution of fever. Further research is needed to determine the economic significance of short-course levofloxacin therapy.

Evaluation of pulmonary lesions with F-18 FDG PET: Comparison of findings in patients with primary pulmonary lesions, pulmonary lesions with history of prior malignancey, and clinically or radiographically suspicious thoracic lymph nodes

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

Knight, S.B.; Delbeke, D.; Campbell, M.G.

1994-05-01

The efficacy of Positron Emission Tomography with F-18 FDG in distinguishing benign from malignant lesions is evaluated and compared in three clinically distinct patient populations. Twenty-four patients with pulmonary lesions or thoracic lymph nodes suspicious for malignancy underwent FDG PET scanning. Pathologic proof of diagnosis was obtained for all patients by thoracotomy (n=18), endobronchial biopsy (n=3), mediastinoscopy (n=2) or sputum cytology (n=1).

Impact of live interactive teledermatology on diagnosis, disease management, and clinical outcomes.

PubMed

Lamel, Sonia; Chambers, Cindy J; Ratnarathorn, Mondhipa; Armstrong, April W

2012-01-01

To assess the impact of live interactive teledermatology consultations on changes in diagnosis, disease management, and clinical outcomes. We conducted a retrospective analysis of 1500 patients evaluated via live interactive teledermatology between 2003 and 2005 at the University of California, Davis. We compared diagnoses and treatment plans between the referring physicians and the teledermatologists. Patients with 2 or more teledermatology visits within a 1-year period were assessed for changes in clinical outcomes. Academic medical center with an established teledermatology program since 1996. Medical records were evaluated for 1500 patients who underwent live interactive teledermatology consultation. Patients seen for more than 1 teledermatology visit were included in the clinical outcome assessment. Live interactive teledermatology consultation. Changes in diagnosis, disease management, and clinical outcome. Compared with diagnoses and treatment plans from referring physicians, the 1500 live interactive teledermatology consultations resulted in changes in diagnosis in 69.9% of patients and changes in disease management in 97.7% of patients. Among 313 patients with at least 2 teledermatology visits within 1 year, clinical improvement was observed in 68.7% of patients. Multivariate analysis showed that changes in diagnosis (P = .01), changes in disease management (P < .001), and the number of teledermatology visits (P < .001) were significantly associated with improved clinical outcomes. Live interactive teledermatology consultations result in changes in diagnosis and disease management in most consultations. The numbers of live interactive teledermatology visits and changes in diagnosis and disease management are significantly associated with improved clinical outcomes.

Development and pilot testing of an interprofessional patient-centered team training programme in medical rehabilitation clinics in Germany: a process evaluation.

PubMed

Becker, Sonja; Körner, Mirjam; Müller, Christian; Lippenberger, Corinna; Rundel, Manfred; Zimmermann, Linda

2017-07-14

Interprofessional teamwork is considered to be a key component of patient-centred treatment in healthcare, and especially in the rehabilitation sector. To date, however, no interventions exist for improving teamwork in rehabilitation clinics in Germany. A team training programme was therefore designed that is individualised in content but standardised regarding methods and process. It is clinic specific, task related, solution focused and context oriented. The aim of the study was to implement and evaluate this training for interprofessional teams in rehabilitation clinics in Germany. The measure consists of a training of a varying number of sessions with rehabilitation teams that consists of four distinct phases. Those are undergone chronologically, each with clinic-specific contents. It was implemented between 2013 and 2014 in five rehabilitation clinics in Germany and evaluated by the participants via questionnaire (n = 52). Staff in three clinics evaluated the programme as helpful, in particular rating moderation, discussions and communication during the training positively. Staff in the remaining two clinics rated it as not very or not helpful and mentioned long-term structural problems or a lack of need for team training as a reason for this. The team training is applicable and accepted by staff. It should, however, be tested in a greater sample and compared with a control group. Processes should be studied in more detail in order to determine what differentiates successful from non-successful interventions and the different requirements each of these might have.

Block versus longitudinal integrated clerkships: students' views of rural clinical supervision.

PubMed

Witney, Martin; Isaac, Vivian; Playford, Denese; Walker, Leesa; Garne, David; Walters, Lucie

2018-07-01

Medical students undertaking longitudinal integrated clerkships (LICs) train in multiple disciplines concurrently, compared with students in block rotations who typically address one medical discipline at a time. Current research suggests that LICs afford students increased access to patients and continuity of clinical supervision. However, these factors are less of an issue in rural placements where there are fewer learners. The aim of this study was to compare rural LIC and rural block rotation students' reported experiences of clinical supervision. De-identified data from the 2015 version of the Australian national rural clinical schools (RCSs) exit survey was used to compare students in LICs with those in block rotations in relation to how they evaluate their clinical supervisors and how they rate their own clinical competence. Multivariate general linear modelling showed no association between placement type (LIC versus Block) and reported clinical supervision. The single independent predictor of positive perception of clinical supervisors was choosing an RCS as a first preference. There was also no association between placement type (LIC versus Block) and self-rated clinical competence. Instead, the clinical supervision score and male gender predicted more positive self-ratings of clinical competence. The quality of clinical supervision in block placements and LIC programmes in rural Australian settings was reported by students as equivalent. © 2018 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Gait patterns after intraarticular treatment of patients with osteoarthritis of the Knee - Hyaluronan versus triamcinolone: a prospective, randomized, doubleblind, monocentric study

PubMed Central

2009-01-01

Objective Evaluation of gait performance and muscle activity patterns as well as clinical efficacy and safety after single intraarticular injection with hyaluronan compared with triamcinolone in patients with knee osteoarthritis. Materials and Methods This trial evaluated the influence of a single injection of hyaluronan or triamcinolone on gait pattern and muscle activity. For clinical evaluation a visual analogue scale for pain, Lequesne index, and Knee Society Score were used. Quality of life was assessed with the SF-36. Results The complete analysis was performed in 50 of 60 patients. 26 patients were treated with triamcinolone and 24 with hyaluronan. Hyaluronan treatment led to significant improvement of range of motion at hip and knee. Significant improvement could be either demonstrated for the pain scale, Lequesne and Knee Society score in both groups. Quality of life showed greater improvement in the triamcinolone group. Conclusion Single application of high-viscosity hyaluronan shows superior range of motion and pain reduction as well as improvement in clinical results. Even if there was a lack of significant differences compared to triamcinolone, this therapy classified as safe and effective in the short follow up. PMID:19380288

Task-oriented evaluation of electronic medical records systems: development and validation of a questionnaire for physicians

PubMed Central

2004-01-01

Background Evaluation is a challenging but necessary part of the development cycle of clinical information systems like the electronic medical records (EMR) system. It is believed that such evaluations should include multiple perspectives, be comparative and employ both qualitative and quantitative methods. Self-administered questionnaires are frequently used as a quantitative evaluation method in medical informatics, but very few validated questionnaires address clinical use of EMR systems. Methods We have developed a task-oriented questionnaire for evaluating EMR systems from the clinician's perspective. The key feature of the questionnaire is a list of 24 general clinical tasks. It is applicable to physicians of most specialties and covers essential parts of their information-oriented work. The task list appears in two separate sections, about EMR use and task performance using the EMR, respectively. By combining these sections, the evaluator may estimate the potential impact of the EMR system on health care delivery. The results may also be compared across time, site or vendor. This paper describes the development, performance and validation of the questionnaire. Its performance is shown in two demonstration studies (n = 219 and 80). Its content is validated in an interview study (n = 10), and its reliability is investigated in a test-retest study (n = 37) and a scaling study (n = 31). Results In the interviews, the physicians found the general clinical tasks in the questionnaire relevant and comprehensible. The tasks were interpreted concordant to their definitions. However, the physicians found questions about tasks not explicitly or only partially supported by the EMR systems difficult to answer. The two demonstration studies provided unambiguous results and low percentages of missing responses. In addition, criterion validity was demonstrated for a majority of task-oriented questions. Their test-retest reliability was generally high, and the non-standard scale was found symmetric and ordinal. Conclusion This questionnaire is relevant for clinical work and EMR systems, provides reliable and interpretable results, and may be used as part of any evaluation effort involving the clinician's perspective of an EMR system. PMID:15018620

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.

Task-oriented evaluation of electronic medical records systems: development and validation of a questionnaire for physicians.

PubMed

Laerum, Hallvard; Faxvaag, Arild

2004-02-09

Evaluation is a challenging but necessary part of the development cycle of clinical information systems like the electronic medical records (EMR) system. It is believed that such evaluations should include multiple perspectives, be comparative and employ both qualitative and quantitative methods. Self-administered questionnaires are frequently used as a quantitative evaluation method in medical informatics, but very few validated questionnaires address clinical use of EMR systems. We have developed a task-oriented questionnaire for evaluating EMR systems from the clinician's perspective. The key feature of the questionnaire is a list of 24 general clinical tasks. It is applicable to physicians of most specialties and covers essential parts of their information-oriented work. The task list appears in two separate sections, about EMR use and task performance using the EMR, respectively. By combining these sections, the evaluator may estimate the potential impact of the EMR system on health care delivery. The results may also be compared across time, site or vendor. This paper describes the development, performance and validation of the questionnaire. Its performance is shown in two demonstration studies (n = 219 and 80). Its content is validated in an interview study (n = 10), and its reliability is investigated in a test-retest study (n = 37) and a scaling study (n = 31). In the interviews, the physicians found the general clinical tasks in the questionnaire relevant and comprehensible. The tasks were interpreted concordant to their definitions. However, the physicians found questions about tasks not explicitly or only partially supported by the EMR systems difficult to answer. The two demonstration studies provided unambiguous results and low percentages of missing responses. In addition, criterion validity was demonstrated for a majority of task-oriented questions. Their test-retest reliability was generally high, and the non-standard scale was found symmetric and ordinal. This questionnaire is relevant for clinical work and EMR systems, provides reliable and interpretable results, and may be used as part of any evaluation effort involving the clinician's perspective of an EMR system.

Patient stratification in the management of acute bacterial exacerbation of chronic bronchitis: the role of levofloxacin 750 mg.

PubMed

Martinez, F J; Grossman, R F; Zadeikis, N; Fisher, A C; Walker, K; Ambruzs, M E; Tennenberg, A M

2005-06-01

This is the first prospective clinical trial in which patients with acute bacterial exacerbation of chronic bronchitis have been stratified by degree of underlying illness. Uncomplicated patients were randomised to levofloxacin 750 mg once daily (q.d.) for 3 days or azithromycin q.d. for 5 days. Complicated patients were randomised to levofloxacin 750 mg q.d. for 5 days or amoxicillin 875 mg/clavulanate 125 mg twice daily for 10 days. Regardless of therapy, complicated patients demonstrated lower clinical and microbiological success than uncomplicated patients. Clinical success for clinically evaluable patients was similar for levofloxacin and azithromycin (93.0 versus 90.1%, respectively), and levofloxacin and amoxicillin/clavulanate (79.2 versus 81.7%, respectively). For microbiologically evaluable patients, clinical response to levofloxacin for 3 days was superior to azithromycin for 5 days (96.3 versus 87.4%, respectively), and levofloxacin for 5 days was similar to amoxicillin/clavulanate for 10 days (81.4 versus 80.9%, respectively). Microbiological eradication was superior for levofloxacin for 3 days compared with azithromycin for 5 days (93.8 versus 82.8%, respectively), and similar for levofloxacin and amoxicillin/clavulanate for 10 days (81.4 versus 79.8%, respectively). In conclusion, levofloxacin 750 mg for 3 days was comparable to azithromycin for 5 days for uncomplicated patients with acute bacterial exacerbation of chronic bronchitis, while 5 days of 750 mg levofloxacin was comparable to 10 days of amoxicillin/clavulanate for complicated acute bacterial exacerbation of chronic bronchitis.

Survival with Three-Times Weekly In-Center Nocturnal Versus Conventional Hemodialysis

PubMed Central

Xu, Jianglin; Suri, Rita S.; Nesrallah, Gihad; Lindsay, Robert; Garg, Amit X.; Lester, Keith; Ofsthun, Norma; Lazarus, Michael; Hakim, Raymond M.

2012-01-01

Whether the duration of hemodialysis treatments improves outcomes remains controversial. Here, we evaluated survival and clinical changes associated with converting from conventional hemodialysis (mean=3.75 h/treatment) to in-center nocturnal hemodialysis (mean=7.85 h/treatment). All 959 consecutive patients who initiated nocturnal hemodialysis for the first time in 77 Fresenius Medical Care facilities during 2006 and 2007 were eligible. We used Cox models to compare risk for mortality during 2 years of follow-up in a 1:3 propensity score–matched cohort of 746 nocturnal and 2062 control patients on conventional hemodialysis. Two-year mortality was 19% among nocturnal hemodialysis patients compared with 27% among conventional patients. Nocturnal hemodialysis associated with a 25% reduction in the risk for death after adjustment for age, body mass index, and dialysis vintage (hazard ratio=0.75, 95% confidence interval=0.61–0.91, P=0.004). With respect to clinical features, interdialytic weight gain, albumin, hemoglobin, dialysis dose, and calcium increased on nocturnal therapy, whereas postdialysis weight, predialysis systolic blood pressure, ultrafiltration rate, phosphorus, and white blood cell count declined (all P<0.001). In summary, notwithstanding the possibility of residual selection bias, conversion to treatment with nocturnal hemodialysis associates with favorable clinical features, laboratory biomarkers, and improved survival compared with propensity score–matched controls. The potential impact of extended treatment time on clinical outcomes while maintaining a three times per week hemodialysis schedule requires evaluation in future clinical trials. PMID:22362905

Clinical Evaluation of a Novel and Mobile Autism Risk Assessment

ERIC Educational Resources Information Center

Duda, Marlena; Daniels, Jena; Wall, Dennis P.

2016-01-01

The Mobile Autism Risk Assessment (MARA) is a new, electronically administered, 7-question autism spectrum disorder (ASD) screen to triage those at highest risk for ASD. Children 16 months-17 years (N = 222) were screened during their first visit in a developmental-behavioral pediatric clinic. MARA scores were compared to diagnosis from the…

Cognitive-Behavioral Therapy for Anxiety Disordered Youth: A Randomized Clinical Trial Evaluating Child and Family Modalities

ERIC Educational Resources Information Center

Kendall, Philip C.; Hudson, Jennifer L.; Gosch, Elizabeth; Flannery-Schroeder, Ellen; Suveg, Cynthia

2008-01-01

This randomized clinical trial compared the relative efficacy of individual (child) cognitive-behavioral therapy (ICBT), family cognitive-behavioral therapy (FCBT), and a family-based education/support/attention (FESA) active control for treating anxiety disordered youth ages 7-14 years (M = 10.27). Youth (N = 161; 44% female; 85% Caucasian, 9%…

A Preliminary Comparison of Reading Subtypes in a Clinical Sample of Children with Specific Language Impairment

ERIC Educational Resources Information Center

Werfel, Krystal L.; Krimm, Hannah

2017-01-01

Purpose: The purpose of this preliminary study was to (a) compare the pattern of reading subtypes among a clinical sample of children with specific language impairment (SLI) and children with typical language and (b) evaluate phonological and nonphonological language deficits within each reading impairment subtype. Method: Participants were 32…

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

99mTc-sestamibi scintigraphy used to evaluate tumor response to neoadjuvant chemotherapy in locally advanced breast cancer: A quantitative analysis

PubMed Central

KOGA, KATIA HIROMOTO; MORIGUCHI, SONIA MARTA; NETO, JORGE NAHÁS; PERES, STELA VERZINHASSE; SILVA, EDUARDO TINÓIS DA; SARRI, ALMIR JOSÉ; MICHELIN, ODAIR CARLITO; MARQUES, MARIANGELA ESTHER ALENCAR; GRIVA, BEATRIZ LOTUFO

2010-01-01

To evaluate the tumor response to neoadjuvant chemotherapy, 99mTc-sestamibi breast scintigraphy was proposed as a quantitative method. Fifty-five patients with ductal carcinoma were studied. They underwent breast scintigraphy before and after neoadjuvant chemotherapy, along with clinical assessment and surgical specimen analysis. The regions of interest on the lesion and contralateral breast were identified, and the pixel counts were used to evaluate lesion uptake in relation to background radiation. The ratio of these counts before to after neoadjuvant chemotherapy was assessed. The decrease in uptake rate due to chemotherapy characterized the scintigraphy tumor response. The Kruskal-Wallis test was used to compare the mean scintigraphic tumor response and histological type. Dunn’s multiple comparison test was used to detect differences between histological types. The Mann-Whitney test was used to compare means between quantitative and qualitative variables: scintigraphic tumor response vs. clinical response and uptake before chemotherapy vs. scintigraphic tumor response. The Spearman’s test was used to correlate the quantitative variables of clinical reduction in tumor size and scintigraphic tumor response. All of the variables compared presented significant differences. The change in 99mTc-sestamibi uptake noted on breast scintigraphy, before to after neoadjuvant chemotherapy, may be used as an effective method for evaluating the response to neoadjuvant chemotherapy, since this quantification reflects the biological behavior of the tumor towards the chemotherapy regimen. Furthermore, additional analysis on the uptake rate before chemotherapy may accurately predict treatment response. PMID:22966312

Comparing the Efficacy of Ophthalmic NSAIDs in Common Indications: A Literature Review to Support Cost-effective Prescribing.

PubMed

Wilson, Daniel J; Schutte, Scott M; Abel, Steven R

2015-06-01

To review the commercially available ophthalmic nonsteroidal anti-inflammatory drugs (NSAIDs), identify opportunities for therapeutic substitutions within and outside of their Food and Drug Administration (FDA)-approved indications, and identify clinically superior drugs within the class for specific indications. A PubMed search (1992 through January 2014) was performed on the terms diclofenac, ketorolac, flurbiprofen, bromfenac, and nepafenac. Clinical trials, meta-analyses, and review articles were evaluated if they were written in English and pertained to human subjects. Studies were excluded if they were in vitro studies, solely evaluated pharmacokinetic or pharmacodynamic properties, did not relate to the topical ophthalmic route, did not evaluate the FDA-approved indications of any available ophthalmic NSAID, or compared a reviewed drug with a nonreviewed drug (without placebo comparison). A total of 67 articles met the criteria for evaluation. Article quality, study design, and dosing of the medications were assessed to determine the clinical applicability of the results. The quality of the article was determined using the Oxford Centre for Evidence-based Medicine Levels of Evidence 1. Many formulations of the 5 reviewed NSAIDs have been studied across the 4 primary indications. These indications are (1) pain and inflammation associated with cataract surgery, (2) pain associated with corneal refractive surgery, (3) inhibition of intraoperative miosis, and (4) seasonal allergic conjunctivitis. Several studies have directly compared drugs within this class and have identified instances in which certain selections are therapeutically superior or equivalent to another. This information provides practitioners with guidance in selecting an optimal medication. © The Author(s) 2015.

Evaluation of a microwave method for dry matter determination in faecal samples from weaned pigs with or without clinical diarrhoea.

PubMed

Pedersen, Ken Steen; Stege, Helle; Nielsen, Jens Peter

2011-07-01

Microwave drying as a procedure for determination of faecal dry matter in weaned pigs was evaluated and clinical relevant cut-off values between faecal consistency scores were determined. Repeatability and reproducibility were evaluated. Overall coefficient of variation was 0.03. The 95% confidence limits for any future faecal subsample examined by any operator in any replica were ± 0.85% faecal dry matter. Robustness in relation to weight of wet faeces was evaluated. The weight categories were 0.5, 1.0, 1.5, 2.0 and 3.0 g. Samples of 0.5 g gave significantly different mean faecal dry matter content compared to weighing of 1.0-3.0 g. Agreement with freeze-drying was evaluated. Lin's concordance correlation coefficient was 0.94. On average the faecal dry matter values was 1.7% (SD=1.99%) higher in freeze dried compared to micro waved samples. Non-parametric ROC analyses were used to determine optimal faecal dry matter cut-off values for clinical faecal consistency scores. The 4 consistency scores were score 1=firm and shaped, score 2=soft and shaped, score 3=loose and score 4=watery. The cut-off values were score 1: faecal dry matter content >19.5%, score 2: faecal dry matter content ≤ 19.5% and >18.0%, score 3: faecal dry matter content ≤ 18.0% and >11.3%, score 4: faecal dry matter content ≤ 11.3%. In conclusion, the microwave procedure has an acceptable repeatability/reproducibility and good agreement with freeze drying can be expected. A minimum of 1.0 g of wet faeces must be used for analyses. Faecal dry matter cut-off values between 4 different clinical consistency scores were determined. © 2011 Elsevier B.V. All rights reserved.

Usefulness of myocardial parametric imaging to evaluate myocardial viability in experimental and in clinical studies.

PubMed

Korosoglou, G; Hansen, A; Bekeredjian, R; Filusch, A; Hardt, S; Wolf, D; Schellberg, D; Katus, H A; Kuecherer, H

2006-03-01

To evaluate whether myocardial parametric imaging (MPI) is superior to visual assessment for the evaluation of myocardial viability. Myocardial contrast echocardiography (MCE) was assessed in 11 pigs before, during, and after left anterior descending coronary artery occlusion and in 32 patients with ischaemic heart disease by using intravenous SonoVue administration. In experimental studies perfusion defect area assessment by MPI was compared with visually guided perfusion defect planimetry. Histological assessment of necrotic tissue was the standard reference. In clinical studies viability was assessed on a segmental level by (1) visual analysis of myocardial opacification; (2) quantitative estimation of myocardial blood flow in regions of interest; and (3) MPI. Functional recovery between three and six months after revascularisation was the standard reference. In experimental studies, compared with visually guided perfusion defect planimetry, planimetric assessment of infarct size by MPI correlated more significantly with histology (r2 = 0.92 versus r2 = 0.56) and had a lower intraobserver variability (4% v 15%, p < 0.05). In clinical studies, MPI had higher specificity (66% v 43%, p < 0.05) than visual MCE and good accuracy (81%) for viability detection. It was less time consuming (3.4 (1.6) v 9.2 (2.4) minutes per image, p < 0.05) than quantitative blood flow estimation by regions of interest and increased the agreement between observers interpreting myocardial perfusion (kappa = 0.87 v kappa = 0.75, p < 0.05). MPI is useful for the evaluation of myocardial viability both in animals and in patients. It is less time consuming than quantification analysis by regions of interest and less observer dependent than visual analysis. Thus, strategies incorporating this technique may be valuable for the evaluation of myocardial viability in clinical routine.

Upgrading from VVI to DDD pacing Mode during elective replacement of pulse generator: a comparative clinical-functional analysis.

PubMed

Teno, Luiz Antonio Castilho; Costa, Roberto; Martinelli Filho, Martino; Castilho, Fabian Cecchi Teno; Ruiz, Ivan

2007-02-01

Evaluate the clinical and functional behavior of the ventricular and atrioventricular stimulation modes in the elective replacement of pulse generator in patients with chagasic cardiopathy and atrioventricular block. Twenty-seven patients under ventricular and atrioventricular stimulation were comparatively evaluated at the beginning of the study, and alternately in ventricular and atrioventricular modes in two 90-day phases, with regard to: the clinical behavior evaluated according to quality of life and functional class, and the functional behavior evaluated by transthoracic echocardiography and the six-minute walk test. The statistical analysis was performed with patients at baseline, and under ventricular and atrioventricular modes, using the chi-square test and the repeated measures analysis of variance, and taking into consideration a 0.05 level of significance. The mean quality-of-life scores were: functional capacity (VVI 71.3+/-18.2 , DDD 69.3+/-20.4); overall health status (VVI 68.1+/-21.8, DDD 69.4+/-19.4) and vitality (VVI 64.8+/-24.6 , DDD 67.6+/-25.5); on echocardiography: LVEF (VVI 52.5+/-12.8 , DDD 51.8+/-14.9), LVDD (VVI 53.0+/-7.7 , DDD 42.4+/-7.8), LA (VVI 38.6+/-5.4 DDD 38.5+/-5.1), and in the six-minute walk test: distance walked (VVI 463.4+/-84.7, DDD 462.6+/-63.4). There were four cases of complications, three of them associated with the change in stimulation mode. This study showed no differences between the two stimulation modes in the clinical behavior assessed by quality of life and functional class, and in the functional behavior, evaluated according to the ecochardiographic findings and the six-minute walk test.

Clinical benefits of remote versus transtelephonic monitoring of implanted pacemakers.

PubMed

Crossley, George H; Chen, Jane; Choucair, Wassim; Cohen, Todd J; Gohn, Douglas C; Johnson, W Ben; Kennedy, Eleanor E; Mongeon, Luc R; Serwer, Gerald A; Qiao, Hongyan; Wilkoff, Bruce L

2009-11-24

The purpose of this study was to evaluate remote pacemaker interrogation for the earlier diagnosis of clinically actionable events compared with traditional transtelephonic monitoring and routine in-person evaluation. Pacemaker patient follow-up procedures have evolved from evaluating devices with little programmability and diagnostic information solely in person to transtelephonic rhythm strip recordings that allow monitoring of basic device function. More recently developed remote monitoring technology leverages expanded device capabilities, augmenting traditional transtelephonic monitoring to evaluate patients via full device interrogation. The time to first diagnosis of a clinically actionable event was compared in patients who were followed by remote interrogation (Remote) and those who were followed per standard of care with office visits augmented by transtelephonic monitoring (Control). Patients were randomized 2:1. Remote arm patients transmitted pacemaker information at 3-month intervals. Control arm patients with a single-chamber pacemaker transmitted at 2-month intervals. Control arm patients with dual-chamber devices transmitted at 2-month intervals with an office visit at 6 months. All patients were seen in office at 12 months. The mean time to first diagnosis of clinically actionable events was earlier in the Remote arm (5.7 months) than in the Control arm (7.7 months). Three (2%) of the 190 events in the Control arm and 446 (66%) of 676 events in the Remote arm were identified remotely. The strategic use of remote pacemaker interrogation follow-up detects actionable events that are potentially important more quickly and more frequently than transtelephonic rhythm strip recordings. The use of transtelephonic rhythm strips for pacemaker follow-up is of little value except for battery status determinations. (PREFER [Pacemaker Remote Follow-up Evaluation and Review]; NCT00294645).

Comparative analysis of perceptual evaluation, acoustic analysis and indirect laryngoscopy for vocal assessment of a population with vocal complaint.

PubMed

Nemr, Kátia; Amar, Ali; Abrahão, Marcio; Leite, Grazielle Capatto de Almeida; Köhle, Juliana; Santos, Alexandra de O; Correa, Luiz Artur Costa

2005-01-01

As a result of technology evolution and development, methods of voice evaluation have changed both in medical and speech and language pathology practice. To relate the results of perceptual evaluation, acoustic analysis and medical evaluation in the diagnosis of vocal and/or laryngeal affections of the population with vocal complaint. Clinical prospective. 29 people that attended vocal health protection campaign were evaluated. They were submitted to perceptual evaluation (AFPA), acoustic analysis (AA), indirect laryngoscopy (LI) and telelaryngoscopy (TL). Correlations between medical and speech language pathology evaluation methods were established, verifying possible statistical signification with the application of Fischer Exact Test. There were statistically significant results in the correlation between AFPA and LI, AFPA and TL, LI and TL. This research study conducted in a vocal health protection campaign presented correlations between speech language pathology evaluation and perceptual evaluation and clinical evaluation, as well as between vocal affection and/or laryngeal medical exams.

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.

Cardiac CT for myocardial ischaemia detection and characterization--comparative analysis.

PubMed

Bucher, A M; De Cecco, C N; Schoepf, U J; Wang, R; Meinel, F G; Binukrishnan, S R; Spearman, J V; Vogl, T J; Ruzsics, B

2014-11-01

The assessment of patients presenting with symptoms of myocardial ischaemia remains one of the most common and challenging clinical scenarios faced by physicians. Current imaging modalities are capable of three-dimensional, functional and anatomical views of the heart and as such offer a unique contribution to understanding and managing the pathology involved. Evidence has accumulated that visual anatomical coronary evaluation does not adequately predict haemodynamic relevance and should be complemented by physiological evaluation, highlighting the importance of functional assessment. Technical advances in CT technology over the past decade have progressively moved cardiac CT imaging into the clinical workflow. In addition to anatomical evaluation, cardiac CT is capable of providing myocardial perfusion parameters. A variety of CT techniques can be used to assess the myocardial perfusion. The single energy first-pass CT and dual energy first-pass CT allow static assessment of myocardial blood pool. Dynamic cardiac CT imaging allows quantification of myocardial perfusion through time-resolved attenuation data. CT-based myocardial perfusion imaging (MPI) is showing promising diagnostic accuracy compared with the current reference modalities. The aim of this review is to present currently available myocardial perfusion techniques with a focus on CT imaging in light of recent clinical investigations. This article provides a comprehensive overview of currently available CT approaches of static and dynamic MPI and presents the results of corresponding clinical trials.

Ultra-wide-field scanning laser ophthalmoscopy assists in the clinical detection and evaluation of asymptomatic early-stage familial exudative vitreoretinopathy.

PubMed

Lyu, Jiao; Zhang, Qi; Wang, Shi-Yuan; Chen, Yi-Ye; Xu, Yu; Zhao, Pei-Quan

2017-01-01

This study aims to investigate the ability of the ultra-wide-field scanning laser ophthalmoscope (UWF SLO) in clinically detecting and evaluating asymptomatic early-stage familial exudative vitreoretinopathy (FEVR). We retrospectively reviewed 163 eyes of 83 asymptomatic family members of 48 patients with FEVR. UWF SLO imaging (Optos® PLC, Scotland, UK) was performed on asymptomatic family members as a preliminary screening test for fundus anomalies, and the findings were compared with subsequent examinations using indirect fundus ophthalmoscopy in full mydriasis, fluorescein angiography (FA), fundus autoflourescence, and genetic sequencing. A total of 86 eyes of 43 asymptomatic family members were clinically diagnosed with early-stage FEVR, and 17 of the affected 43 family members were also genetically diagnosed. Compared with FA as a standard, the UWF SLO was highly effective in diagnosing FEVR with a sensitivity and specificity of 93.0 % and 97.5 %, respectively. The UWF SLO was able to diagnose early-stage FEVR in 93.0 % of eyes, and guided the selection of therapies in 46.5 % of the eyes studied. UWF SLO is a valuable imaging tool for detecting fundus anomalies related to early-stage FEVR, and this tool can assist in the clinical diagnosis and evaluation of early-stage FEVR in asymptomatic family members of patients with FEVR.

Effects of structured written feedback by cards on medical students' performance at Mini Clinical Evaluation Exercise (Mini-CEX) in an outpatient clinic.

PubMed

Haghani, Fariba; Hatef Khorami, Mohammad; Fakhari, Mohammad

2016-07-01

Feedback cards are recommended as a feasible tool for structured written feedback delivery in clinical education while effectiveness of this tool on the medical students' performance is still questionable.  The purpose of this study was to compare the effects of structured written feedback by cards as well as verbal feedback versus verbal feedback alone on the clinical performance of medical students at the Mini Clinical Evaluation Exercise (Mini-CEX) test in an outpatient clinic. This is a quasi-experimental study with pre- and post-test comprising four groups in two terms of medical students' externship. The students' performance was assessed through the Mini-Clinical Evaluation Exercise (Mini-CEX) as a clinical performance evaluation tool. Structured written feedbacks were given to two experimental groups by designed feedback cards as well as verbal feedback, while in the two control groups feedback was delivered verbally as a routine approach in clinical education. By consecutive sampling method, 62 externship students were enrolled in this study and seven students were excluded from the final analysis due to their absence for three days. According to the ANOVA analysis and Post Hoc Tukey test,  no statistically significant difference was observed among the four groups at the pre-test, whereas a statistically significant difference was observed between the experimental and control groups at the post-test  (F = 4.023, p =0.012). The effect size of the structured written feedbacks on clinical performance was 0.19. Structured written feedback by cards could improve the performance of medical students in a statistical sense. Further studies must be conducted in other clinical courses with longer durations.

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.

SU-E-QI-19: Evaluation of a Clinical 1.5T MRI for Prostate Cancer MRS Imaging Using a In Vivo Tumor Model

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

Chen, X; Chen, L; Hensley, H

2014-06-15

Purpose: Magnetic resonance spectroscopic (MRS) imaging may provide important bio-markers to distinguish normal/cancerous prostate tissue. While MRS imaging requires a high uniform magnetic field, the ability of a clinical 1.5T MRI to achieve a comparable MRS signal is of interest for radiation treatment planning/assessment. This study is to evaluate the MRS imaging of a 1.5T clinical MRI for prostate cancers by comparing with a small animal 7T MRS scanner. Methods: A tumor model was developed by implanting LNCaP tumor cells in nude mice prostates. Tumor was monitored 3 weeks after implantation using MRI, and MRS imaging was performed on themore » tumor area when the tumor reached around 1cm in diameter. The 1.5T GE clinical MR scanner and the 7T Bruker small animal MR scanner were used for each mouse. MR spectrums acquired with these scanners were analyzed and compared. The signals of Choline and Citrate were considered. Results: The prostate tumor MR spectrum under the 1.5T clinical MRI showed a similar spectrum pattern to that acquired using the 7T animal MRI. The Choline signal (3.2ppm) is clear and there is no clear peak for Citrate (2.6ppm). However, the signal magnitude for Choline is not dominant compared to the background signal under 1.5T MRI. Typical cancerous prostate tissue MR spectrum with an increased Choline signal and a reduced Citrate signal was observed. In addition, signal variation is noticeable between repeated spectrum scans. The average of these scans showed a comparable and consistent spectrum to those under 7T MRI. Conclusion: The clinical 1.5T MRI is able to acquire a MR spectrum for prostate cancer comparable to those acquired using a dedicated 7T MRS scanner. However, to achieve a consistent and reliable spectrum, multiple repeated scans were necessary to get a statistical result and reduce the noise-induced artifact. This work was supported in part by the National Cancer Institute Grant R21 CA131979 and R01CA172638.« less

Design and implementation of a controlled clinical trial to evaluate the effectiveness and efficiency of routine opt-out rapid human immunodeficiency virus screening in the emergency department.

PubMed

Haukoos, Jason S; Hopkins, Emily; Byyny, Richard L; Conroy, Amy A; Silverman, Morgan; Eisert, Sheri; Thrun, Mark; Wilson, Michael; Boyett, Brian; Heffelfinger, James D

2009-08-01

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDC's recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Addressing "waste" in diagnostic imaging: some implications of comparative effectiveness research.

PubMed

Elshaug, Adam G; Bessen, Taryn; Moss, John R; Hiller, Janet E

2010-08-01

Comparative effectiveness research is intended to provide evidence to improve patient outcomes through the use of the most appropriate health technology affordable. The authors present 5 case studies, focusing on the use of plain radiography in common clinical scenarios, to illustrate the considerable scope for comparative effectiveness research within medical imaging and the different levels of evidence currently in existence to guide the improved use of medical imaging. These are blunt ankle injury, breast cancer follow-up, low back pain, routine daily chest x-rays in intensive care, and screening for breast cancer. Although there are established models for evaluating new technologies, especially pharmaceuticals, against the most commonly used current technology, the evaluation of technologies in current clinical practice is in an early phase of development. Because evaluation resources are limited, one major challenge is developing ways to identify established technologies for evaluation to refine the indications for their use. A set of criteria with which to identify established technologies that may not be delivering value for money is described, and their use is illustrated in relation to the 5 case studies. These criteria could be incorporated into literature search strategies, stakeholder consultations, and utilization scanning. Once identified, these technologies should be formally evaluated for their performance in improving patient health without restricting the availability of other effective interventions. Copyright 2010 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Simple maneuvers to reduce the incidence of false-negative findings for contralateral patent processus vaginalis during laparoscopic hernia repair in children: a comparative study between 2 cohorts.

PubMed

Tam, Yuk Him; Wong, Yuen Shan; Chan, Kin Wai; Pang, Kristine Kit Yi; Tsui, Siu Yan; Mou, Jennifer Wai Cheung; Sihoe, Jennifer Dart Yin; Lee, Kim Hung

2013-04-01

Transumbilical or transinguinal laparoscopic evaluation for contralateral patent processus vaginalis (CPPV) is commonly performed during laparoscopic or open hernia repair in children but may occasionally give false-negative findings. A retrospective study was conducted to compare 2 cohorts of children who underwent laparoscopic repair for clinically demonstrated unilateral inguinal hernia and evaluation for CPPV by transumbilical laparoscopy during the study periods of 2004 to 2007 (cohort 1) and 2008 to 2011 (cohort 2). Cohort 1 was a known historical cohort with CPPV being evaluated by laparoscopic inspection alone, whereas additional maneuvers were adopted in cohort 2. There were 395 and 564 patients in cohorts 1 and 2, respectively. There was no difference between the 2 cohorts in age of patients, sex distribution, laterality of clinically demonstrated inguinal hernia, and follow-up period at the time of data collection. More CPPV were diagnosed in cohort 2 than cohort 1(36.2% vs 25.8%; P < .01). 4 children (1.4%) developed metachronous inguinal hernia following negative laparoscopic evaluation for CPPV in cohort 1 compared with none from cohort 2 at a similar median follow-up period (P < .05). The additional maneuvers appear to be superior to laparoscopic inspection alone to evaluate CPPV during laparoscopic hernia repair in children. Copyright © 2013 Elsevier Inc. All rights reserved.

SU-C-BRA-06: Developing Clinical and Quantitative Guidelines for a 4DCT-Ventilation Functional Avoidance Clinical Trial

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

Vinogradskiy, Y; Waxweiler, T; Diot, Q

Purpose: 4DCT-ventilation is an exciting new imaging modality that uses 4DCTs to calculate lung ventilation. Because 4DCTs are acquired as part of routine care, calculating 4DCT-ventilation allows for lung function evaluation without additional cost or inconvenience to the patient. Development of a clinical trial is underway at our institution to use 4DCT-ventilation for thoracic functional avoidance with the idea that preferential sparing of functional lung regions can decrease pulmonary toxicity. The purpose of our work was to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial including: 1.assessing patient eligibility 2.developing trial inclusion criteria and 3.developing treatment planningmore » and dose-function evaluation strategies. Methods: 96 stage III lung cancer patients from 2 institutions were retrospectively reviewed. 4DCT-ventilation maps were calculated using the patient’s 4DCTs, deformable image registrations, and a density-change-based algorithm. To assess patient eligibility and develop trial inclusion criteria we used an observer-based binary end point noting the presence or absence of a ventilation defect and developed an algorithm based on the percent ventilation in each lung third. Functional avoidance planning integrating 4DCT-ventilation was performed using rapid-arc and compared to the patient’s clinically used plan. Results: Investigator-determined clinical ventilation defects were present in 69% of patients. Our regional/lung-thirds ventilation algorithm identified that 59% of patients have lung functional profiles suitable for functional avoidance. Compared to the clinical plan, functional avoidance planning was able to reduce the mean dose to functional lung by 2 Gy while delivering comparable target coverage and cord/heart doses. Conclusions: 4DCT-ventilation functional avoidance clinical trials have great potential to reduce toxicity, and our data suggest that 59% of lung cancer patients have lung function profiles suitable for functional avoidance. Our study used a retrospective evaluation of a large lung cancer patient database to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial. (R.C., E.C., T.G.), NIH Research Scientist Development Award K01-CA181292 (R.C.), and State of Colorado Advanced Industries Accelerator Grant (Y.V.)« less

Clinical Value of Vestibular Evoked Myogenic Potential in Assessing the Stage and Predicting the Hearing Results in Ménière's Disease

PubMed Central

Kim, Min-Beom; Choi, Jeesun; Park, Ga Young; Cho, Yang-Sun; Hong, Sung Hwa

2013-01-01

Objectives Our goal was to find the clinical value of cervical vestibular evoked myogenic potential (VEMP) in Ménière's disease (MD) and to evaluate whether the VEMP results can be useful in assessing the stage of MD. Furthermore, we tried to evaluate the clinical effectiveness of VEMP in predicting hearing outcomes. Methods The amplitude, peak latency and interaural amplitude difference (IAD) ratio were obtained using cervical VEMP. The VEMP results of MD were compared with those of normal subjects, and the MD stages were compared with the IAD ratio. Finally, the hearing changes were analyzed according to their VEMP results. Results In clinically definite unilateral MD (n=41), the prevalence of cervical VEMP abnormality in the IAD ratio was 34.1%. When compared with normal subjects (n=33), the VEMP profile of MD patients showed a low amplitude and a similar latency. The mean IAD ratio in MD was 23%, which was significantly different from that of normal subjects (P=0.01). As the stage increased, the IAD ratio significantly increased (P=0.09). After stratification by initial hearing level, stage I and II subjects (hearing threshold, 0-40 dB) with an abnormal IAD ratio showed a decrease in hearing over time compared to those with a normal IAD ratio (P=0.08). Conclusion VEMP parameters have an important clinical role in MD. Especially, the IAD ratio can be used to assess the stage of MD. An abnormal IAD ratio may be used as a predictor of poor hearing outcomes in subjects with early stage MD. PMID:23799160

Fractional carbon dioxide laser versus low-dose UVA-1 phototherapy for treatment of localized scleroderma: a clinical and immunohistochemical randomized controlled study.

PubMed

Shalaby, S M; Bosseila, M; Fawzy, M M; Abdel Halim, D M; Sayed, S S; Allam, R S H M

2016-11-01

Morphea is a rare fibrosing skin disorder that occurs as a result of abnormal homogenized collagen synthesis. Fractional ablative laser resurfacing has been used effectively in scar treatment via abnormal collagen degradation and induction of healthy collagen synthesis. Therefore, fractional ablative laser can provide an effective modality in treatment of morphea. The study aimed at evaluating the efficacy of fractional carbon dioxide laser as a new modality for the treatment of localized scleroderma and to compare its results with the well-established method of UVA-1 phototherapy. Seventeen patients with plaque and linear morphea were included in this parallel intra-individual comparative randomized controlled clinical trial. Each with two comparable morphea lesions that were randomly assigned to either 30 sessions of low-dose (30 J/cm 2 ) UVA-1 phototherapy (340-400 nm) or 3 sessions of fractional CO 2 laser (10,600 nm-power 25 W). The response to therapy was then evaluated clinically and histopathologically via validated scoring systems. Immunohistochemical analysis of TGF-ß1 and MMP1 was done. Patient satisfaction was also assessed. Wilcoxon signed rank test for paired (matched) samples and Spearman rank correlation equation were used as indicated. Comparing the two groups, there was an obvious improvement with fractional CO 2 laser that was superior to that of low-dose UVA-1 phototherapy. Statistically, there was a significant difference in the clinical scores (p = 0.001), collagen homogenization scores (p = 0.012), and patient satisfaction scores (p = 0.001). In conclusion, fractional carbon dioxide laser is a promising treatment modality for cases of localized morphea, with proved efficacy of this treatment on clinical and histopathological levels.

Evaluation of echocardiography in the management of elderly patients with heart failure.

PubMed

Hendry, A; Hacking, L; Langhorne, P; Vallance, R; MacDonald, J

1999-09-01

To determine the validity of a clinical diagnosis of systolic dysfunction in elderly patients with heart failure and assess the contribution of echocardiography to their management. 61 elderly patients with a diagnosis of heart failure in a geriatric assessment unit setting. Prospective study determining sensitivity, specificity and predictive values of a clinical and radiological diagnosis compared with echocardiographic standard. Proposed management was compared before and after echocardiography. Clinical assessment was highly sensitive (93%) but lacked specificity (32%). Combining radiological and clinical diagnoses increased specificity to 58%. Echocardiography revised the lead cardiac diagnosis for 28% of patients and influenced patient management plans for 41%. For elderly patients with heart failure, echocardiography improves diagnostic accuracy and identifies those patients with potential to benefit from angiotensin-converting enzyme inhibitors.

Outcome reporting following navigated high tibial osteotomy of the knee: a systematic review.

PubMed

Yan, James; Musahl, Volker; Kay, Jeffrey; Khan, Moin; Simunovic, Nicole; Ayeni, Olufemi R

2016-11-01

This systematic review evaluates radiographic and clinical outcome reporting following navigated high tibial osteotomy (HTO). Conventional HTO was used as a control to compare outcomes and furthermore investigate the quality of evidence in studies reporting outcomes for navigated HTO. It was hypothesized that navigated HTO will show superior clinical and radiographic outcomes compared to conventional HTO. Two independent reviewers searched PubMed, Ovid (MEDLINE), EMBASE, and Cochrane databases for studies reporting outcomes following navigated HTO. Titles, abstracts, and full-text were screened in duplicate using an a priori inclusion and exclusion criteria. Descriptive statistics were calculated using Minitab ® statistical software. Methodological Index for Nonrandomized Studies (MINORS) and Cochrane Risk of Bias Scores were used to evaluate methodological quality. Thirty-four studies which involved 2216 HTOs were analysed in this review, 1608 (72.6 %) navigated HTOs and 608 (27.4 %) conventional HTOs. The majority of studies were of level IV evidence (16). Clinical outcomes were reported in knee and function scores or range of motion comparisons. Postoperative clinical and functional scores were improved by navigated HTO although it is not demonstrated if there is significant improvement compared to conventional HTO. Most common clinical outcome score reported was Lysholm scores (6) which report postoperative scores of 87.8 (standard deviation 5.9) and 88.8 (standard deviation 5.9) for conventional and navigation-assisted HTO, respectively. Radiographic outcomes reported commonly were weight-bearing mechanical axis, coronal plane angle, and posterior tibial slope angle in the sagittal plane. Studies have shown HTO gives significant correction of mechanical alignment and navigated HTO produces significantly less change in posterior tibial slope postoperatively compared to conventional. The mean MINORS for the 17 non-comparative studies was 9/16, and 15/24 for the 14 non-randomized comparative studies. Navigation HTO results in improved mechanical axis alignment and demonstrates significantly better control over the tibial slope angle change postoperatively compared to conventional methods; however, these improvements have not yet been reflected in clinical outcome scores. Overall the studies report HTO does create significantly improved knee scores and functions compared to patients' preoperative ratings regardless of technique. Future studies on HTO outcomes need to focus on consistency of outcome reporting. IV.

Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States

PubMed Central

McClure, Erin A.; King, Jacqueline S.; Wahle, Aimee; Matthews, Abigail G.; Sonne, Susan C.; Lofwall, Michelle R.; McRae-Clark, Aimee L.; Ghitza, Udi E.; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S.; Gray, Kevin M.

2017-01-01

Background Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment Episodes Data Set – Admissions. Methods Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. Results Results showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. Conclusions These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. PMID:28511033

Comparing adult cannabis treatment-seekers enrolled in a clinical trial with national samples of cannabis users in the United States.

PubMed

McClure, Erin A; King, Jacqueline S; Wahle, Aimee; Matthews, Abigail G; Sonne, Susan C; Lofwall, Michelle R; McRae-Clark, Aimee L; Ghitza, Udi E; Martinez, Melissa; Cloud, Kasie; Virk, Harvir S; Gray, Kevin M

2017-07-01

Cannabis use rates are increasing among adults in the United States (US) while the perception of harm is declining. This may result in an increased prevalence of cannabis use disorder and the need for more clinical trials to evaluate efficacious treatment strategies. Clinical trials are the gold standard for evaluating treatment, yet study samples are rarely representative of the target population. This finding has not yet been established for cannabis treatment trials. This study compared demographic and cannabis use characteristics of a cannabis cessation clinical trial sample (run through National Drug Abuse Treatment Clinical Trials Network) with three nationally representative datasets from the US; 1) National Survey on Drug Use and Health, 2) National Epidemiologic Survey on Alcohol and Related Conditions-III, and 3) Treatment: Episodes Data Set - Admissions. Comparisons were made between the clinical trial sample and appropriate cannabis using sub-samples from the national datasets, and propensity scores were calculated to determine the degree of similarity between samples. showed that the clinical trial sample was significantly different from all three national datasets, with the clinical trial sample having greater representation among older adults, African Americans, Hispanic/Latinos, adults with more education, non-tobacco users, and daily and almost daily cannabis users. These results are consistent with previous studies of other substance use disorder populations and extend sample representation issues to a cannabis use disorder population. This illustrates the need to ensure representative samples within cannabis treatment clinical trials to improve the generalizability of promising findings. Copyright © 2017 Elsevier B.V. All rights reserved.

Implementing Cognitive Behavioral Therapy for Chronic Fatigue Syndrome in a Mental Health Center: A Benchmarking Evaluation

ERIC Educational Resources Information Center

Scheeres, Korine; Wensing, Michel; Knoop, Hans; Bleijenberg, Gijs

2008-01-01

Objective: This study evaluated the success of implementing cognitive behavioral therapy (CBT) for chronic fatigue syndrome (CFS) in a representative clinical practice setting and compared the patient outcomes with those of previously published randomized controlled trials (RCTs) of CBT for CFS. Method: The implementation interventions were the…

A Hypoxia-Targeted Boron Neutron Capture Therapy Agent for the Treatment of Glioma.

PubMed

Luderer, Micah John; Muz, Barbara; de la Puente, Pilar; Chavalmane, Sanmathi; Kapoor, Vaishali; Marcelo, Raymundo; Biswas, Pratim; Thotala, Dinesh; Rogers, Buck; Azab, Abdel Kareem

2016-10-01

Boron neutron capture therapy (BNCT) has the potential to become a viable cancer treatment modality, but its clinical translation has been limited by the poor tumor selectivity of agents. To address this unmet need, a boronated 2-nitroimidazole derivative (B-381) was synthesized and evaluated for its capability of targeting hypoxic glioma cells. B-381 has been synthesized from a 1-step reaction. Using D54 and U87 glioma cell lines, the in vitro cytotoxicity and cellular accumulation of B-381 has been evaluated under normoxic and hypoxic conditions compared to L-boronophenylalanine (BPA). Furthermore, tumor retention of B-381 was evaluated in vivo. B-381 had low cytotoxicity in normal and cancer cells. Unlike BPA, B-381 illustrated preferential retention in hypoxic glioma cells compared to normoxic glioma cells and normal tissues in vitro. In vivo, B-381 illustrated significantly higher long-term tumor retention compared to BPA, with 9.5-fold and 6.5-fold higher boron levels at 24 and 48 h, respectively. B-381 represents a new class of BNCT agents in which their selectivity to tumors is based on hypoxic tumor metabolism. Further studies are warranted to evaluate B-381 and similar compounds as preclinical candidates for future BNCT clinical trials for the treatment of glioma.

Incremental cost effectiveness evaluation in clinical research.

PubMed

Krummenauer, Frank; Landwehr, I

2005-01-28

The health economic evaluation of therapeutic and diagnostic strategies is of increasing importance in clinical research. Therefore also clinical trialists have to involve health economic aspects more frequently. However, whereas they are quite familiar with classical effect measures in clinical trials, the corresponding parameters in health economic evaluation of therapeutic and diagnostic procedures are still not this common. The concepts of incremental cost effectiveness ratios (ICERs) and incremental net health benefit (INHB) will be illustrated and contrasted along the cost effectiveness evaluation of cataract surgery with monofocal and multifocal intraocular lenses. ICERs relate the costs of a treatment to its clinical benefit in terms of a ratio expression (indexed as Euro per clinical benefit unit). Therefore ICERs can be directly compared to a pre-specified willingness to pay (WTP) benchmark, which represents the maximum costs, health insurers would invest to achieve one clinical benefit unit. INHBs estimate a treatment's net clinical benefit after accounting for its cost increase versus an established therapeutic standard. Resource allocation rules can be formulated by means of both effect measures. Both the ICER and the INHB approach enable the definition of directional resource allocation rules. The allocation decisions arising from these rules are identical, as long as the willingness to pay benchmark is fixed in advance. Therefore both strategies crucially call for a priori determination of both the underlying clinical benefit endpoint (such as gain in vision lines after cataract surgery or gain in quality-adjusted life years) and the corresponding willingness to pay benchmark. The use of incremental cost effectiveness and net health benefit estimates provides a rationale for health economic allocation discussions and founding decisions. It implies the same requirements on trial protocols as yet established for clinical trials, that is the a priori definition of primary hypotheses (formulated as an allocation rule involving a pre-specified willingness to pay benchmark) and the primary clinical benefit endpoint (as a rationale for effectiveness evaluation).

Surgical Treatment of Combined Posterior Root Tears of the Lateral Meniscus and ACL Tears

PubMed Central

Pan, Fengyu; Hua, Shan; Ma, Zhuang

2015-01-01

Background The treatment of anterior cruciate ligament (ACL) rupture complicated with posterior lateral meniscus root (PLMR) tears remains controversial. The goal of this study was to evaluate clinical outcomes of PLMR tear refixation versus left untreated at the time of reconstruction. Material/Methods From August 2001 to January 2012, 31 patients who undergone repair of PLMR tears were evaluated and compared with a matched control group with untreated PLMR tears. Clinical evaluation consisted of the Lysholm scale, subjective International Knee Documentation Committee (IKDC) questionnaires, and radiographic evaluation with MRI. Results Regarding to the Lysholm score and the subjective questionnaire score, there were no statistical difference between the 2 groups. However, patients after operative treatment reach higher functional scores and lower rates of osteoarthritis (normal: group A, 80%, and group B, 48%, respectively) with statistical significance (P<0.05) compared to the matched control group. Conclusions Surgical and conservative treatment of the PLMR can both effectively improve knee function. However, a tendency towards higher functional scores and lower rates of osteoarthritis for patients with operative treatment was observed. PMID:25959903

Effect of patient decision aid was influenced by presurgical evaluation among patients with osteoarthritis of the knee.

PubMed

Boland, Laura; Taljaard, Monica; Dervin, Geoffrey; Trenaman, Logan; Tugwell, Peter; Pomey, Marie-Pascale; Stacey, Dawn

2017-12-01

Decision aids help patients make total joint arthroplasty decisions, but presurgical evaluation might influence the effects of a decision aid. We compared the effects of a decision aid among patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes. We performed a subgroup analysis of a randomized controlled trial. Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education. We compared the effects of decision quality, decisional conflict and surgery rate using Cochran-Mantel-Haenszel χ 2 tests and the Breslow-Day test. We evaluated 242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls). Results suggested a between-site difference in the effect of the decision aid on the patients' decision quality ( p = 0.09): at the academic site, patients who used the decision were more likely to make better-quality decisions than controls (54% v. 35%, p = 0.044), but not at the community site (47% v. 51%, p = 0.71). Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p = 0.007) (33% v. 52%, p = 0.05 at the academic site and 40% v. 24%, p = 0.08 at the community site). The effect of the decision aid on surgery rates did not differ between sites ( p = 0.65). The decision aid had a greater effect at the academic site than at the community site, which provided longer consultations with more verbal education. Hence, decision aids might be of greater value when more extensive total knee arthroplasty presurgical assessment and counselling are either impractical or unavailable.

Effect of patient decision aid was influenced by presurgical evaluation among patients with osteoarthritis of the knee.

PubMed

Boland, Laura; Taljaard, Monica; Dervin, Geoffrey; Trenaman, Logan; Tugwell, Peter; Pomey, Marie-Pascale; Stacey, Dawn

2018-02-01

Decision aids help patients make total joint arthroplasty decisions, but presurgical evaluation might influence the effects of a decision aid. We compared the effects of a decision aid among patients considering total knee arthroplasty at 2 surgical screening clinics with different evaluation processes. We performed a subgroup analysis of a randomized controlled trial. Patients were recruited from 2 surgical screening clinics: an academic clinic providing 20-minute physician consultations and a community clinic providing 45-minute physiotherapist/nurse consultations with education. We compared the effects of decision quality, decisional conflict and surgery rate using Cochran-Mantel-Haenszel χ 2 tests and the Breslow-Day test. We evaluated 242 patients: 123 from the academic clinic (61 who used the decision aid and 62 controls) and 119 from the community clinic (59 who used the decision aid and 60 controls). Results suggested a between-site difference in the effect of the decision aid on the patients' decision quality ( p = 0.09): at the academic site, patients who used the decision aid were more likely to make better-quality decisions than controls (54% v. 35%, p = 0.044), but not at the community site (47% v. 51%, p = 0.71). Fewer patients who used decision aids at the academic site than at the community site experienced decisional conflict ( p = 0.007) (33% v. 52%, p = 0.05 at the academic site and 40% v. 24%, p = 0.08 at the community site). The effect of the decision aid on surgery rates did not differ between sites ( p = 0.65). The decision aid had a greater effect at the academic site than at the community site, which provided longer consultations with more verbal education. Hence, decision aids might be of greater value when more extensive total knee arthroplasty presurgical assessment and counselling are either impractical or unavailable.

Difference of Success Rates of Mineral Trioxide Aggregate Pulpotomies Performed Both by Undergraduate Dental Students and by an Expert Operator: A Retrospective Study.

PubMed

Pasini, Marco; Giuca, Maria Rita; Gatto, Roberto; Caruso, Silvia

2017-01-01

The aim of this retrospective study was to evaluate the clinical and radiographic success of pulpotomy on primary molars performed by dental students compared to that performed by an expert operator. The study was conducted on 142 second primary molars in 102 children. The patients were randomly selected from the available records. The test group (treated by dental students) included 51 subjects (28 males and 23 females, mean age: 7.2 ± 1) and the control group included 51 children (29 males and 22 females, mean age: 7.4 ± 1.2 years). After pulpotomy, a clinical and radiographic evaluation after 12 months was performed. Chi-square test and odds ratio were calculated and significance level was set at p < 0.05. The success rate was significantly lower, 81.6% ( p < 0.05), in the test group than in the control group (93%). The test group showed less clinical and radiographic success (86% and 80%, resp.) compared to the control group (97.2% for clinical success and 93% for radiographic success). Pulpotomy with MTA is an effective method that ensures a good percentage of success. The clinical experience of the operator is a contributing factor.

Prospective study of bacteraemia in acute haemorrhagic diarrhoea syndrome in dogs.

PubMed

Unterer, S; Lechner, E; Mueller, R S; Wolf, G; Straubinger, R K; Schulz, B S; Hartmann, K

2015-03-21

In dogs with idiopathic acute haemorrhagic diarrhoea syndrome (AHDS), a serious loss of intestinal mucosal barrier integrity occurs. However, the incidence of bacterial translocation in dogs with idiopathic AHDS is not known. Thus, the objectives of this prospective study were to identify the incidence of bacteraemia, to evaluate the frequency of septic events and the influence of bacteraemia on various clinical and laboratory parameters, duration of hospitalisation and survival of dogs with idiopathic AHDS. The study included 87 dogs with idiopathic AHDS. Twenty-one healthy dogs served as control group. To evaluate clinical significance of bacterial translocation, blood culture results were compared between patients and controls. Clinical and laboratory parameters were compared between patients with positive and negative blood cultures. There was no significant difference in either incidence of bacteraemia between patients with idiopathic AHDS (11 per cent) and controls (14 per cent) or in severity of clinical signs, laboratory parameters, duration of hospitalisation or mortality between blood culture-positive and culture-negative dogs with idiopathic AHDS. The results of this study suggest that the incidence of bacteraemia in dogs with idiopathic AHDS is low and not different from that of healthy control dogs. Bacteraemia does not influence the clinical course or survival and thus antibiotic treatment is not indicated to prevent sepsis. British Veterinary Association.

Problem-based learning versus a traditional educational methodology: a comparison of preclinical and clinical periodontics performance.

PubMed

Rich, Sandra K; Keim, Robert G; Shuler, Charles F

2005-06-01

To evaluate efficacy of a problem-based learning (PBL) pedagogy in preclinical and clinical teaching, test scores of 234 undergraduate dental students from the conventionally taught classes of 2003 and 2004 were compared with scores of 274 dental students from the PBL classes of 2005 and 2006. Although the groups' means were close together, t-test analysis of scores revealed that PBL students performed significantly better than traditional (TRAD) students on midterm (p=.0001) and final (p=.015) examinations taken on student partner/mock patients. ANOVA comparing the classes with each other showed significant differences for the midterm and final, but not for the clinical examination. Further multiple comparison tests (Tukey HSD) for the midterm and final revealed that differences specifically reflected superior performance of PBL classes against one of the TRAD classes (2004). There was no difference in performance between PBL (n=134) and TRAD (n=233) students on examinations taken with actual clinical patients who were undergoing nonsurgical periodontal treatment. Over a two-year period, PBL students rated their program instructors at a mean of 4.41 on a Likert-type scale of 1 (not helpful) to 5 (outstanding). The program provides a PBL model for teaching preclinical and clinical skills supported by a four-year evaluation of manual skills outcomes.

Diagnostic Approach to Acute Diarrheal Illness in a Military Population on Training Exercises in Thailand, a Region of Campylobacter Hyperendemicity▿

PubMed Central

Tribble, David R.; Baqar, Shahida; Pang, Lorrin W.; Mason, Carl; Houng, Huo-Shu H.; Pitarangsi, Chittima; Lebron, Carlos; Armstrong, Adam; Sethabutr, Orntipa; Sanders, John W.

2008-01-01

High rates of Campylobacter fluoroquinolone resistance highlight the need to evaluate diagnostic strategies that can be used to assist with clinical management. Diagnostic tests were evaluated with U.S. soldiers presenting with acute diarrhea during deployment in Thailand. The results of bedside and field laboratory diagnostic tests were compared to stool microbiology findings for 182 enrolled patients. Campylobacter jejuni was isolated from 62% of the cases. Clinical and laboratory findings at the time of presentation were evaluated to determine their impact on the posttest probability, defined as the likelihood of a diagnosis of Campylobacter infection. Clinical findings, the results of tests for inflammation (stool occult blood testing [Hemoccult], fecal leukocytes, fecal lactoferrin, plasma C-reactive protein), and the numbers of Campylobacter-specific antibody-secreting cells in peripheral blood failed to increase the posttest probability above 90% in this setting of Campylobacter hyperendemicity when these findings were present. Positive results by a Campylobacter-specific commercial enzyme immunoassay (EIA) and, less so, a research PCR were strong positive predictors. The negative predictive value for ruling out Campylobacter infection, defined as a posttest probability of less than 10%, was similarly observed with these Campylobacter-specific stool-based tests as well the fecal leukocyte test. Compared to the other tests evaluated, the Campylobacter EIA is a sensitive and specific rapid diagnostic test that may assist with diagnostic evaluation, with consideration of the epidemiological setting, logistics, and cost. PMID:18234869

Evaluation of a miniature microscope objective designed for fluorescence array microscopy detection of Mycobacterium tuberculosis.

PubMed

McCall, Brian; Olsen, Randall J; Nelles, Nicole J; Williams, Dawn L; Jackson, Kevin; Richards-Kortum, Rebecca; Graviss, Edward A; Tkaczyk, Tomasz S

2014-03-01

A prototype miniature objective that was designed for a point-of-care diagnostic array microscope for detection of Mycobacterium tuberculosis and previously fabricated and presented in a proof of concept is evaluated for its effectiveness in detecting acid-fast bacteria. To evaluate the ability of the microscope to resolve submicron features and details in the image of acid-fast microorganisms stained with a fluorescent dye, and to evaluate the accuracy of clinical diagnoses made with digital images acquired with the objective. The lens prescription data for the microscope design are presented. A test platform is built by combining parts of a standard microscope, a prototype objective, and a digital single-lens reflex camera. Counts of acid-fast bacteria made with the prototype objective are compared to counts obtained with a standard microscope over matched fields of view. Two sets of 20 smears, positive and negative, are diagnosed by 2 pathologists as sputum smear positive or sputum smear negative, using both a standard clinical microscope and the prototype objective under evaluation. The results are compared to a reference diagnosis of the same sample. More bacteria are counted in matched fields of view in digital images taken with the prototype objective than with the standard clinical microscope. All diagnostic results are found to be highly concordant. An array microscope built with this miniature lens design will be able to detect M tuberculosis with high sensitivity and specificity.

Treatment of Focal Articular Cartilage Defects in the Knee

PubMed Central

Magnussen, Robert A.; Dunn, Warren R.; Carey, James L.

2008-01-01

We asked whether autologous chondrocyte implantation or osteochondral autograft transfer yields better clinical outcomes compared with one another or with traditional abrasive techniques for treatment of isolated articular cartilage defects and whether lesion size influences this clinical outcome. We performed a literature search and identified five randomized, controlled trials and one prospective comparative trial evaluating these treatment techniques in 421 patients. The operative procedures included autologous chondrocyte implantation, osteochondral autograft transfer, matrix-induced autologous chondrocyte implantation, and microfracture. Minimum followup was 1 year (mean, 1.7 years; range, 1–3 years). All studies documented greater than 95% followup for clinical outcome measures. No technique consistently had superior results compared with the others. Outcomes for microfracture tended to be worse in larger lesions. All studies reported improvement in clinical outcome measures in all treatment groups when compared with preoperative assessment; however, no control (nonoperative) groups were used in any of the studies. A large prospective trial investigating these techniques with the addition of a control group would be the best way to definitively address the clinical questions. Level of Evidence: Level II, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:18196358

Economic evaluation of genomic sequencing in the paediatric population: a critical review.

PubMed

Alam, Khurshid; Schofield, Deborah

2018-05-24

Systematic evidence is critical to the formulation of national health policy to provide public funding for the integration of genomic sequencing into routine clinical care. The purpose of this review is to present systematic evidence on the economic evaluation of genomic sequencing conducted for paediatric patients in clinical care, and to identify any gaps in the methodology of economic evaluations. We undertook a critical review of the empirical evidence from economic evaluations of genomic sequencing among paediatric patients searching five electronic databases. Our inclusion criteria were limited to literature published in the English language between 2010 and 2017 in OECD countries. Articles that met our inclusion criteria were assessed using a recognised checklist for a well-designed economic evaluation. We found 11 full-text articles that met our inclusion criteria. Our analysis found that genomic sequencing markedly increased the diagnostic rate to 16-79%, but lowered the cost by 11-64% compared to the standard diagnostic pathway. Only five recent studies in paediatric clinical cohorts met most of the criteria for a well-designed economic evaluation and demonstrated cost-effectiveness of genomic sequencing in paediatric clinical cohorts of patients. Our review identified the need for improvement in the rigour of the methodologies used to provide robust evidence for the formulation of health policy on public funding to integrate genomic sequencing into routine clinical care. Nonetheless, there is emerging evidence of the cost-effectiveness of genomic sequencing over usual care for paediatric patients.

Resuscitation skills after Helping Babies Breathe training: a comparison of varying practice frequency and impact on retention of skills in different types of providers.

PubMed

Tabangin, M E; Josyula, S; Taylor, K K; Vasquez, J C; Kamath-Rayne, B D

2018-05-01

Helping Babies Breathe (HBB), a basic neonatal resuscitation curriculum, improves early neonatal mortality in low-resource settings. Our goal was to determine retention of resuscitation skills by different cadres of providers using the approved HBB Spanish translation in a rural clinic and community hospital in Honduras. Twelve clinic and 37 hospital providers were trained in 1 d HBB workshops and followed from July 2012 to February 2014. Resuscitation skills were evaluated by objective structured clinical evaluations (OSCEs) at regular intervals. Clinic providers practiced monthly, whereas hospital providers were randomized to monthly practice for 6 months vs three consecutive practices at 3, 5 and 6 months. In the rural clinic, follow-up OSCE assessment showed rapid loss of skills by 1 month after HBB training. For all providers, repeated monthly testing resulted in improvements and maintenance of OSCE performance. In the community hospital, over all time points, the group with monthly OSCEs had 2.9 greater odds of passing compared with the group who practiced less frequently. Physicians were found to have 4.3 times greater odds of passing compared with nurses. Rapid loss of resuscitation skills occurs after an initial training. Repeated practice leads to retention of skills in all types of providers. Further investigation is warranted to determine the clinical correlation of neonatal outcomes after HBB training.

Clinical comparison and complete cure rates of Terbinafine efficacy in affected onychomycotic toenails.

PubMed

Shemer, A; Sakka, N; Baran, R; Scher, R; Amichai, B; Norman, L; Farhi, R; Magun, R; Brazilai, A; Daniel, R

2015-03-01

Clinical studies regarding complete cure rate of onychomycosis using oral Terbinafine have a very broad range (14-90%) based solely on response to treatment on the big toenail. To evaluate the efficacy of Terbinafine in all affected onychomycotic toenails and, furthermore, to evaluate differences in mycological, clinical and complete cure rate between affected onychomycotic toenails. Inclusion criteria are as follows: distolateralsubungual onychomycotic involvement of the hallux and additional involvement of at least two more toenails of the same foot. Exclusion criteria are as follows: patients with nail traumata and hypersensitivity to Terbinafine. Patients were treated with oral Terbinafine 250 mg/day for 16 weeks. Mycological analysis was performed using direct microscopy and culture. Clinical improvement was assessed using digital photography. Statistically significant difference was found in clinical improvement between the great toenail and all other involved toenails. The rate of complete cure (100% clinical cure and mycological cure) of the big toenail was lower (23%) as compared to the second (65%), third (51%) and the fourth toenail (67%). This is a case series study that was based on a single-centre cohort. Our results support findings that efficacy of Terbinafine should be based on all involved onychomycotic toenails; the big toenail is not superior in response compared to other affected toenails. © 2014 European Academy of Dermatology and Venereology.

Efficacy of feline anti-parvovirus antibodies in the treatment of canine parvovirus infection.

PubMed

Gerlach, M; Proksch, A L; Unterer, S; Speck, S; Truyen, U; Hartmann, K

2017-07-01

This prospective, randomised, placebo-controlled, double-blinded study aimed to evaluate efficacy of commercially available feline anti-parvovirus antibodies in dogs with canine parvovirus infection. First, cross-protection of feline panleukopenia virus antibodies against canine parvovirus was evaluated in vitro. In the subsequent prospective clinical trial, 31 dogs with clinical signs of canine parvovirus infection and a positive faecal canine parvovirus polymerase chain reaction were randomly assigned to a group receiving feline panleukopenia virus antibodies (n=15) or placebo (n=16). All dogs received additional routine treatment. Clinical signs, blood parameters, time to clinical recovery and mortality were compared between the groups. Serum antibody titres and quantitative faecal polymerase chain reaction were compared on days 0, 3, 7, and 14. In vitro, canine parvovirus was fully neutralised by feline panleukopenia virus antibodies. There were no detected significant differences in clinical signs, time to clinical recovery, blood parameters, mortality, faecal virus load, or viral shedding between groups. Dogs in the placebo group showed a significant increase of serum antibody titres and a significant decrease of faecal virus load between day 14 and day 0, which was not detectable in dogs treated with feline panleukopenia virus antibodies. No significant beneficial effect of passively transferred feline anti-parvovirus antibodies in the used dosage regimen on the treatment of canine parvovirus infection was demonstrated. © 2017 British Small Animal Veterinary Association.

Inter- and intraobserver repeatability of the Salford Gait Tool: an observation-based clinical gait assessment tool.

PubMed

Toro, Brigitte; Nester, Christopher J; Farren, Pauline C

2007-03-01

To evaluate the inter- and intraobserver repeatability of the Salford Gait Tool (SF-GT), a new observation-based gait assessment tool for evaluating sagittal plane cerebral palsy (CP) gait. Masked comparative evaluation. University in the United Kingdom. A convenience sample of 23 pediatric physical therapists with varying degrees of clinical experience recruited from the Greater Manchester area. Participants viewed videotapes of the sagittal plane gait of 13 children and used the SF-GT to analyze their 13 different gait styles on 2 occasions. Eleven children had hemiplegic, diplegic, or quadriplegic CP and 2 were neurologically intact. Inter- and intraobserver repeatability of hip, knee, and ankle joint positions at 6 different phases of the gait cycle. The SF-GT demonstrated good interobserver (77%) and intraobserver (75%) repeatability. We have established that the SF-GT is a repeatable clinical assessment tool with which to guide the diagnosis, treatment planning, and evaluation of interventions by pediatric physical therapists of sagittal plane gait deviations in CP.

Clinical evaluation of liquid placebos for an herbal supplement, STW5, in healthy volunteers.

PubMed

Yoon, Saunjoo L; Grundmann, Oliver; Keane, Devan; Urbano, Theodore; Moshiree, Baharak

2012-10-01

Although clinical trials are needed to evaluate the efficacy of liquid herbal medicinal products, design of feasible placebos that mimic the appearance, taste, and smell of such products is particularly challenging. The design and feasibility of a liquid placebo for STW5, an herbal medicinal product used for various gastrointestinal problems, was explored in this study. Four sample products-STW5, a fresh and aged version of a placebo made from a seasoning mix (Maggi™), and a placebo with aged artificial flavor and food coloring-were compared in two organoleptic (sensory), single-blind trials with a total of 60 (N=60) healthy volunteers (n(1)=30, n(2)=30). The appearance, smell, and taste of each solution were evaluated using a Likert scale questionnaire. The liquid placebos evaluated were similar in regard to appearance, smell, and taste. However, participants indicated that for a clinical trial with STW5, the aged Maggi™ placebo would be more viable compared to the fresh Maggi placebo or the aged artificial food coloring placebo with licorice flavor. Participants also noted that the mint flavor and smell of STW5 was distinctly different from the placebo solutions. The trials were conducted in healthy volunteers, not in actual patients. The aged Maggi™ liquid mix may be more favorable as a placebo than the artificially created one. However, further adjustment will need to be made to the Maggi™ placebo to simulate the complex aromatic composition of STW5 for clinical studies in the future. Copyright © 2012 Elsevier Ltd. All rights reserved.

Comparison of Efficacy Between Endoscopic Cyclophotocoagulation and Alternative Surgeries in Refractory Glaucoma

PubMed Central

Yang, Yangfan; Zhong, Jing; Dun, Zhongjun; Liu, Xiao-an; Yu, Minbin

2015-01-01

Abstract Refractory glaucoma refers to uncontrolled intraocular pressure (IOP) despite anti-glaucoma medication and surgical treatment, which remains a challenge to be treated. The objective of this study is to evaluate and statistically compare the clinical efficacy between endoscopic cyclophotocoagulation (ECP) and alternative surgical techniques in the treatment of refractory glaucoma in this article, as a meta-analysis. Data sources are China Biomedical Database (Sinomed, online version), China National Knowledge Infrastructure (CNKI), Cqvip, Wanfang database, and PubMed. The randomized controlled trial (RCT) and case–control study literatures evaluating the clinical efficacy between ECP and other surgical techniques were searched electronically from public databases. The methodology quality of the retrieved articles was evaluated according to the RCT or case–control study criteria. The success rate of treatment, intraocular pressure (IOP) and visual acuity were statistically compared. RevMan 5.3 software was used for the meta-analysis. In total, 6 relevant control studies were selected in this study with a total sampling of 429 cases (429 eyes), including 204 eyes in the ECP group and 225 in the non-ECP group. Meta-analysis demonstrated that the clinical efficacy did not significantly differ between 2 groups (P > 0.05). Postoperative IOP was dramatically reduced in both groups. However, it was difficult to evaluate the combined influence of ECP and non-ECP therapies upon IOP reduction. In conclusion, ECP and non-ECP treatment yielded almost equivalent clinical efficacy in treating refractory glaucoma. The IOP-lowering degree, safety, and incidence of complications remain to be further elucidated by RCTs with a larger sample size. PMID:26426659

Evaluation of automatic image quality assessment in chest CT - A human cadaver study.

PubMed

Franck, Caro; De Crop, An; De Roo, Bieke; Smeets, Peter; Vergauwen, Merel; Dewaele, Tom; Van Borsel, Mathias; Achten, Eric; Van Hoof, Tom; Bacher, Klaus

2017-04-01

The evaluation of clinical image quality (IQ) is important to optimize CT protocols and to keep patient doses as low as reasonably achievable. Considering the significant amount of effort needed for human observer studies, automatic IQ tools are a promising alternative. The purpose of this study was to evaluate automatic IQ assessment in chest CT using Thiel embalmed cadavers. Chest CT's of Thiel embalmed cadavers were acquired at different exposures. Clinical IQ was determined by performing a visual grading analysis. Physical-technical IQ (noise, contrast-to-noise and contrast-detail) was assessed in a Catphan phantom. Soft and sharp reconstructions were made with filtered back projection and two strengths of iterative reconstruction. In addition to the classical IQ metrics, an automatic algorithm was used to calculate image quality scores (IQs). To be able to compare datasets reconstructed with different kernels, the IQs values were normalized. Good correlations were found between IQs and the measured physical-technical image quality: noise (ρ=-1.00), contrast-to-noise (ρ=1.00) and contrast-detail (ρ=0.96). The correlation coefficients between IQs and the observed clinical image quality of soft and sharp reconstructions were 0.88 and 0.93, respectively. The automatic scoring algorithm is a promising tool for the evaluation of thoracic CT scans in daily clinical practice. It allows monitoring of the image quality of a chest protocol over time, without human intervention. Different reconstruction kernels can be compared after normalization of the IQs. Copyright © 2017 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

The role of objective personality inventories in suicide risk assessment: an evaluation and proposal.

PubMed

Johnson, W B; Lall, R; Bongar, B; Nordlund, M D

1999-01-01

Objective personality assessment instruments offer a comparatively underutilized source of clinical data in attempts to evaluate and predict risk for suicide. In contrast to focal suicide risk measures, global personality inventories may be useful in identification of long-standing styles that predispose persons to eventual suicidal behavior. This article reviews the empirical literature regarding the efficacy of established personality inventories in predicting suicidality. The authors offer several recommendations for future research with these measures and conclude that such objective personality instruments offer only marginal utility as sources of clinical information in comprehensive suicide risk evaluations. Personality inventories may offer greatest utility in long-term assessment of suicide risk.

Twice versus thrice weekly ECT in a clinical population: an evaluation of patient outcomes.

PubMed

Siskind, Dan; Charlson, Fiona; Saraf, Sudeep; Scheurer, Roman; Lie, David Charles

2012-10-30

Increasing demand on electroconvulsive therapy (ECT) services led to a recommendation that low risk patients be considered for twice weekly ECT rather than the usual thrice weekly. We evaluated whether practice changed and compared patient clinical outcomes for twice and thrice weekly ECT. Medical records for all patients receiving ECT in the 2-year study period (1/9/08 to 30/8/10) were reviewed to determine ECT protocol, diagnosis, admission duration and readmission rates. During the study period, 119 patients received 150 treatment courses. Patient outcomes were compared for twice weekly ECT and thrice weekly ECT protocols, as well as for 1 year before and after the recommendation (1/9/09). Twice weekly ECT courses increased (8-20) after the recommendation while thrice weekly ECT courses decreased (64-30). The recommendation had no significant effect on patient outcomes. Comparing twice and thrice weekly ECT, patient clinical outcomes were similar between the two groups, though non-affective twice weekly patients waited longer before starting ECT. In the context of resource constraints, psychiatrists can be influenced to examine and change their ECT prescribing practice. This bodes well for the implementation of evidence-based treatment into mental health services. Secondly, for adults, there appear to be no significant differences in clinical outcomes for twice versus thrice weekly ECT. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

A Pilot Study to Evaluate Effectiveness of INR Self-Testing in Elderly Patients.

PubMed

Pogge, Elizabeth

2015-12-01

To determine if international normalized ratio (INR) patient self-testing (PST) resulted in an increased time in therapeutic range (TTR) in an elderly population when compared with clinic testing over a six-month period. A pilot study and retrospective chart review from August 2010 to August 2014. Ambulatory, anticoagulation clinic with two locations in Sun City West and Peoria, Arizona. Of 91 patients, the data of 20 patients who were 65 years of age or older and had at least six months of pre- and post-PST INR data were extracted and analyzed. The primary outcome evaluated improvement of TTR during post-PST in elderly patients compared with clinic management over a six-month period. Secondary outcomes assessed patients' satisfaction with PST and identified barriers to PST. The post-PST mean TTR significantly increased to 73% from 63.6% for the first six months of PST (P = 0.04). Participants were satisfied with PST, with an average score ranging from 4.6 to 5 on a Likert scale of 1 to 5 on 10 satisfaction survey questions. Cost was identified as the most common barrier to PST, with 43% of patients not participating in PST because of financial burden. With appropriate screening and training, PST is associated with improved TTRs and higher patient satisfaction in elderly patients when compared with clinic testing. Barriers identified to PST include cost, the complex process, and noncompliance.

Cost-effectiveness analysis of a postoperative clinical care pathway in head and neck surgery with microvascular reconstruction.

PubMed

Dautremont, Jonathan F; Rudmik, Luke R; Yeung, Justin; Asante, Tiffany; Nakoneshny, Steve C; Hoy, Monica; Lui, Amanda; Chandarana, Shamir P; Matthews, Thomas W; Schrag, Christiaan; Dort, Joseph C

2013-12-19

The objective of this study is to evaluate the cost-effectiveness of a postoperative clinical care pathway for patients undergoing major head and neck oncologic surgery with microvascular reconstruction. This is a comparative trial of a prospective treatment group managed on a postoperative clinical care pathway and a historical group managed prior to pathway implementation. Effectiveness outcomes evaluated were total hospital days, return to OR, readmission to ICU and rate of pulmonary complications. Costing perspective was from the government payer. 118 patients were included in the study. All outcomes demonstrated that the postoperative pathway group was both more effective and less costly, and is therefore a dominant clinical intervention. The overall mean pre- and post-pathway costs are $22,733 and $16,564 per patient, respectively. The incremental cost reduction associated with the postoperative pathway was $6,169 per patient. Implementing the postoperative clinical care pathway in patients undergoing head and neck oncologic surgery with reconstruction resulted in improved clinical outcomes and reduced costs.

The development and validity of the Salford Gait Tool: an observation-based clinical gait assessment tool.

PubMed

Toro, Brigitte; Nester, Christopher J; Farren, Pauline C

2007-03-01

To develop the construct, content, and criterion validity of the Salford Gait Tool (SF-GT) and to evaluate agreement between gait observations using the SF-GT and kinematic gait data. Tool development and comparative evaluation. University in the United Kingdom. For designing construct and content validity, convenience samples of 10 children with hemiplegic, diplegic, and quadriplegic cerebral palsy (CP) and 152 physical therapy students and 4 physical therapists were recruited. For developing criterion validity, kinematic gait data of 13 gait clusters containing 56 children with hemiplegic, diplegic, and quadriplegic CP and 11 neurologically intact children was used. For clinical evaluation, a convenience sample of 23 pediatric physical therapists participated. We developed a sagittal plane observational gait assessment tool through a series of design, test, and redesign iterations. The tool's grading system was calibrated using kinematic gait data of 13 gait clusters and was evaluated by comparing the agreement of gait observations using the SF-GT with kinematic gait data. Criterion standard kinematic gait data. There was 58% mean agreement based on grading categories and 80% mean agreement based on degree estimations evaluated with the least significant difference method. The new SF-GT has good concurrent criterion validity.

Clinical Equipoise and Shared Decision-making in Pulmonary Nodule Management. A Survey of American Thoracic Society Clinicians.

PubMed

Iaccarino, Jonathan M; Simmons, James; Gould, Michael K; Slatore, Christopher G; Woloshin, Steven; Schwartz, Lisa M; Wiener, Renda Soylemez

2017-06-01

Guidelines for pulmonary nodule evaluation suggest a variety of strategies, reflecting the lack of high-quality evidence demonstrating the superiority of any one approach. It is unclear whether clinicians agree that multiple management options are appropriate at different levels of risk and whether this impacts their decision-making approaches with patients. To assess clinicians' perceptions of the appropriateness of various diagnostic strategies, approach to decision-making, and perceived clinical equipoise in pulmonary nodule evaluation. We developed and administered a web-based survey in March and April, 2014 to clinician members of the American Thoracic Society. The primary outcome was perceived appropriateness of pulmonary nodule evaluation strategies in three clinical vignettes with different malignancy risk. We compared responses to guideline recommendations and analyzed clinician characteristics associated with a reported shared decision-making approach. We also assessed clinicians' likelihood to enroll patients in hypothetical randomized trials comparing nodule evaluation strategies. Of 5,872 American Thoracic Society members e-mailed, 1,444 opened the e-mail and 428 eligible clinicians participated in the survey (response rate, 30.0% among those who opened the invitation; 7% overall). The mean number of options considered appropriate increased with pretest probability of cancer, ranging from 1.8 (SD, 1.2) for the low-risk case to 3.5 (1.1) for the high-risk case (P < 0.0001). As recommended by guidelines, the proportion that deemed surgical resection as an appropriate option also increased with cancer risk (P < 0.0001). One-half of clinicians (50.4%) reported engaging in shared decision-making with patients for pulmonary nodule management; this was more commonly reported by clinicians with more years of experience (P = 0.01) and those who reported greater comfort in managing pulmonary nodules (P = 0.005). Although one-half (49.9%) deemed the evidence for pulmonary nodule evaluation to be strong, most clinicians were willing to enroll patients in randomized trials to compare nodule management strategies in all risk categories (low risk, 87.6%; moderate risk, 89.7%; high risk, 63.0%). Consistent with guideline recommendations, clinicians embrace multiple options for pulmonary nodule evaluation and many are open to shared decision-making. Clinicians support the need for randomized clinical trials to strengthen the evidence for nodule evaluation, which will further improve decision-making.

Performance of Crohn's disease Clinical Trial Endpoints based upon Different Cutoffs for Patient Reported Outcomes or Endoscopic Activity: Analysis of EXTEND Data.

PubMed

Feagan, Brian; Sandborn, William J; Rutgeerts, Paul; Levesque, Barrett G; Khanna, Reena; Huang, Bidan; Zhou, Qian; Maa, Jen-Fue; Wallace, Kori; Lacerda, Ana; Thakkar, Roopal B; Robinson, Anne M

2018-04-23

Clinical trial endpoints for Crohn's disease (CD) activity correlate poorly with mucosal inflammation; to assess treatment efficacy, patient-reported outcomes and endoscopic assessments are preferred. This study assessed the impact on treatment efficacy estimations of using different definitions of clinical and endoscopic remission and endoscopic response, and of using site- or central-based endoscopy evaluation. This post hoc analysis of data fromEXTEND (extend the safety and efficacy of adalimumab through endoscopic healing), a placebo (PBO)-controlled, randomized trial of adalimumab (ADA) for mucosal healing, included adults with moderate-to-severe CD. Subsets of patients meeting specified Simplified Endoscopic Score for CD (SES-CD) inclusion criteria, according to site or central reading, and baseline stool frequency (SF) and/or abdominal pain score (AP) thresholds were evaluated. Various endpoint definitions based on the Crohn's Disease Activity Index (CDAI), its SF and AP components, SES-CD, and composite endpoints were compared between treatment groups. Increased stringency of Week 12 clinical endpoints compared to CDAI<150 to SF≤3.0/1.5&AP≤1.0 reduced PBO response rates by ≥12% and increased treatment effects by ≤10%. Amending the SES-CD endpoint from ≤4 to ≤2 reduced the treatment effect from 24% to 8%. Composite endpoints further diminished response rates and effect sizes. Site-based evaluation was associated with lower remission rates versus central reading in the PBO group and, thus, greater ADA-related treatment effects. This analysis is the first to demonstrate that increasing the stringency of clinical and endoscopic endpoint definitions in CD trials, especially lowering SF or SES-CD definitions, reduces the ability to detect treatment-related change in CD activity; focus on endpoints that reflect clinical change is warranted.

Electronic patient-reported data capture as a foundation of rapid learning cancer care.

PubMed

Abernethy, Amy P; Ahmad, Asif; Zafar, S Yousuf; Wheeler, Jane L; Reese, Jennifer Barsky; Lyerly, H Kim

2010-06-01

"Rapid learning healthcare" presents a new infrastructure to support comparative effectiveness research. By leveraging heterogeneous datasets (eg, clinical, administrative, genomic, registry, and research), health information technology, and sophisticated iterative analyses, rapid learning healthcare provides a real-time framework in which clinical studies can evaluate the relative impact of therapeutic approaches on a diverse array of measures. This article describes an effort, at 1 academic medical center, to demonstrate what rapid learning healthcare might look like in operation. The article describes the process of developing and testing the components of this new model of integrated clinical/research function, with the pilot site being an academic oncology clinic and with electronic patient-reported outcomes (ePROs) being the foundational dataset. Steps included: feasibility study of the ePRO system; validation study of ePRO collection across 3 cancers; linking ePRO and other datasets; implementation; stakeholder alignment and buy in, and; demonstration through use cases. Two use cases are presented; participants were metastatic breast cancer (n = 65) and gastrointestinal cancer (n = 113) patients at 2 academic medical centers. (1) Patient-reported symptom data were collected with tablet computers; patients with breast and gastrointestinal cancer indicated high levels of sexual distress, which prompted multidisciplinary response, design of an intervention, and successful application for funding to study the intervention's impact. (2) The system evaluated the longitudinal impact of a psychosocial care program provided to patients with breast cancer. Participants used tablet computers to complete PRO surveys; data indicated significant impact on psychosocial outcomes, notably distress and despair, despite advanced disease. Results return to the clinic, allowing iterative update and evaluation. An ePRO-based rapid learning cancer clinic is feasible, providing real-time research-quality data to support comparative effectiveness research.

Hepatitis B Vaccine Antibody Response and the Risk of Clinical AIDS or Death

PubMed Central

Landrum, Michael L.; Hullsiek, Katherine Huppler; O'Connell, Robert J.; Chun, Helen M.; Ganesan, Anuradha; Okulicz, Jason F.; Lalani, Tahaniyat; Weintrob, Amy C.; Crum-Cianflone, Nancy F.; Agan, Brian K.

2012-01-01

Background Whether seroresponse to a vaccine such as hepatitis B virus (HBV) vaccine can provide a measure of the functional immune status of HIV-infected persons is unknown.This study evaluated the relationship between HBV vaccine seroresponses and progression to clinical AIDS or death. Methods and Findings From a large HIV cohort, we evaluated those who received HBV vaccine only after HIV diagnosis and had anti-HBs determination 1–12 months after the last vaccine dose. Non-response and positive response were defined as anti-HBs <10 and ≥10 IU/L, respectively. Participants were followed from date of last vaccination to clinical AIDS, death, or last visit. Univariate and multivariable risk of progression to clinical AIDS or death were evaluated with Cox regression models. A total of 795 participants vaccinated from 1986–2010 were included, of which 41% were responders. During 3,872 person-years of observation, 122 AIDS or death events occurred (53% after 1995). Twenty-two percent of non-responders experienced clinical AIDS or death compared with 5% of responders (p<0.001). Non-response to HBV vaccine was associated with a greater than 2-fold increased risk of clinical AIDS or death (HR 2.47; 95% CI, 1.38–4.43) compared with a positive response, after adjusting for CD4 count, HIV viral load, HAART use, and delayed type hypersensitivity skin test responses (an in vivo marker of cell-mediated immunity). This association remained evident among those with CD4 count ≥500 cells/mm3 (HR 3.40; 95% CI, 1.39–8.32). Conclusions HBV vaccine responses may have utility in assessing functional immune status and risk stratificating HIV-infected individuals, including those with CD4 count ≥500 cells/mm3. PMID:22457767

Three-year clinical evaluation of two ceramic crown systems: a preliminary study.

PubMed

Etman, Maged K; Woolford, M J

2010-02-01

The clinical performance and failure mechanisms of recently introduced ceramic crown systems used to restore posterior teeth have not been adequately examined. The purpose of this prospective clinical study was to evaluate and compare the clinical performance of 2 new ceramic crown systems with that of metal ceramic crowns using modified United States Public Health Services (USPHS) criteria. Ninety posterior teeth requiring crown restorations in 48 patients were randomized into 3 equal groups (n=30) for which different crown systems were used: an experimental hot-pressed glass ceramic based on a modified lithium disilicate ceramic (IPS e.max Press), an alumina-coping-based ceramic (Procera AllCeram), and a metal ceramic (Simidur S 2 veneered with IPS Classic Porcelain). The crowns were assessed over 3 years using the modified USPHS criteria. Crowns that developed visible cracks were sectioned and removed, and the surfaces were analyzed using a scanning electron microscope (SEM). The data were analyzed using the Kruskal-Wallis nonparametric statistical test, followed by the Mann-Whitney test with Bonferroni correction (alpha=.05). USPHS evaluation showed that the IPS e.max Press and metal ceramic crowns experienced fewer clinical changes than Procera AllCeram. Visible roughness, wear, and deformity were noticed in occlusal contact areas of Procera AllCeram crowns. SEM images showed well defined wear facets in both ceramic crown systems. Kruskal-Wallis tests showed a significant difference (P<.05) in Alpha scores among the 3 crown systems. Mann-Whitney tests showed significant differences among groups. IPS e.max Press crowns demonstrated clinical behavior comparable to Procera AllCeram and metal ceramic crowns, but the wear resistance of this crown type was superior to the Procera AllCeram crowns, according to modified USPHS criteria.

[The tinnitus questionnaire. A standard instrument for grading the degree of tinnitus. Results of a multicenter study with the tinnitus questionnaire].

PubMed

Goebel, G; Hiller, W

1994-03-01

The clinical examination of patients with severe and chronic tinnitus must include associated psychological disturbances. The present paper describes traditional diagnostic methods of ENT practice as well as the Tinnitus Questionnaire (TQ) which has been evaluated in a number of studies. This instrument differentiates between emotional and cognitive distress, auditory perceptual difficulties and self-experienced intrusiveness produced by the tinnitus. The results of a German multicenter study are presented which show that the TQ can be used to demonstrate differences of tinnitus distress under different clinical conditions (e.g., ENT clinic vs psychosomatic clinic and in- vs out-patient care). The TQ can be employed for comparative studies in different tinnitus-related institutions and for the evaluation of the relative effects of different treatment approaches.

Performance evaluation of three automated identification systems in detecting carbapenem-resistant Enterobacteriaceae.

PubMed

He, Qingwen; Chen, Weiyuan; Huang, Liya; Lin, Qili; Zhang, Jingling; Liu, Rui; Li, Bin

2016-06-21

Carbapenem-resistant Enterobacteriaceae (CRE) is prevalent around the world. Rapid and accurate detection of CRE is urgently needed to provide effective treatment. Automated identification systems have been widely used in clinical microbiology laboratories for rapid and high-efficient identification of pathogenic bacteria. However, critical evaluation and comparison are needed to determine the specificity and accuracy of different systems. The aim of this study was to evaluate the performance of three commonly used automated identification systems on the detection of CRE. A total of 81 non-repetitive clinical CRE isolates were collected from August 2011 to August 2012 in a Chinese university hospital, and all the isolates were confirmed to be resistant to carbapenems by the agar dilution method. The potential presence of carbapenemase genotypes of the 81 isolates was detected by PCR and sequencing. Using 81 clinical CRE isolates, we evaluated and compared the performance of three automated identification systems, MicroScan WalkAway 96 Plus, Phoenix 100, and Vitek 2 Compact, which are commonly used in China. To identify CRE, the comparator methodology was agar dilution method, while the PCR and sequencing was the comparator one to identify CPE. PCR and sequencing analysis showed that 48 of the 81 CRE isolates carried carbapenemase genes, including 23 (28.4 %) IMP-4, 14 (17.3 %) IMP-8, 5 (6.2 %) NDM-1, and 8 (9.9 %) KPC-2. Notably, one Klebsiella pneumoniae isolate produced both IMP-4 and NDM-1. One Klebsiella oxytoca isolate produced both KPC-2 and IMP-8. Of the 81 clinical CRE isolates, 56 (69.1 %), 33 (40.7 %) and 77 (95.1 %) were identified as CRE by MicroScan WalkAway 96 Plus, Phoenix 100, and Vitek 2 Compact, respectively. The sensitivities/specificities of MicroScan WalkAway, Phoenix 100 and Vitek 2 were 93.8/42.4 %, 54.2/66.7 %, and 75.0/36.4 %, respectively. The MicroScan WalkAway and Viteck2 systems are more reliable in clinical identification of CRE, whereas additional tests are required for the Pheonix 100 system. Our study provides a useful guideline for using automated identification systems for CRE identification.

Evaluating the diagnostic accuracy of the Xpert MTB/RIF assay on bronchoalveolar lavage fluid: A retrospective study.

PubMed

Lu, Yanjun; Zhu, Yaowu; Shen, Na; Tian, Lei; Sun, Ziyong

2018-02-08

Limited data on the diagnostic accuracy of the Xpert MTB/RIF assay using bronchoalveolar lavage fluid from patients with suspected pulmonary tuberculosis (PTB) have been reported in China. Therefore, a retrospective study was designed to evaluate the diagnostic accuracy of this assay. Clinical, radiological, and microbiological characteristics of 238 patients with suspected PTB were reviewed retrospectively. The sensitivity, specificity, positive predictive value, and negative predictive value for the diagnosis of active PTB were calculated for the Xpert MTB/RIF assay using TB culture or final diagnosis based on clinical and radiological evaluation as the reference standard. The sensitivity and specificity of the Xpert MTB/RIF assay were 84.5% and 98.9%, respectively, and those for smear microscopy were 36.2% and 100%, respectively, when compared to the culture method. However, compared with the sensitivity and specificity of final diagnosis based on clinical and radiological evaluation, the sensitivity and specificity of the assay were 72.9% and 98.7%, respectively, which were significantly higher than those for smear microscopy. The Xpert MTB/RIF assay on bronchoalveolar lavage fluid could serve as an additional rapid diagnostic tool for PTB in a high TB-burden country and improve the time to TB treatment initiation in patients with PTB. Copyright © 2018 The Author(s). Published by Elsevier Ltd.. All rights reserved.

Antibiotic prophylaxis in hematopoietic stem cell transplantation. A meta-analysis of randomized controlled trials.

PubMed

Kimura, Shun-ichi; Akahoshi, Yu; Nakano, Hirofumi; Ugai, Tomotaka; Wada, Hidenori; Yamasaki, Ryoko; Ishihara, Yuko; Kawamura, Koji; Sakamoto, Kana; Ashizawa, Masahiro; Sato, Miki; Terasako-Saito, Kiriko; Nakasone, Hideki; Kikuchi, Misato; Yamazaki, Rie; Kako, Shinichi; Kanda, Junya; Tanihara, Aki; Nishida, Junji; Kanda, Yoshinobu

2014-07-01

We performed a meta-analysis to evaluate the impact of systemic antibiotic prophylaxis in hematopoietic stem cell transplantation (HSCT) recipients. We collected reports from PubMed, the Cochrane Library, EMBASE, CINAHL, and Web of Science, along with references cited therein. We included prospective, randomized studies on systemic antibiotic prophylaxis in HSCT recipients. Seventeen trials with 1453 autologous and allogeneic HSCT recipients were included. Systemic antibiotic prophylaxis was compared with placebo or no prophylaxis in 10 trials and with non-absorbable antibiotics in two trials. Systemic antibiotics other than fluoroquinolones were evaluated in five of these 12 trials. Four trials evaluated the effect of the addition of antibiotics for gram-positive bacteria to fluoroquinolones. One trial compared two different systemic antibiotic regimens: fluoroquinolones versus trimethoprim-sulfamethoxazole. As a result, systemic antibiotic prophylaxis reduced the incidence of febrile episodes (OR 0.16; 95%CI 0.09-0.30), clinically or microbiologically documented infection (OR 0.38; 95%CI 0.22-0.63) and bacteremia (OR 0.31; 95%CI 0.16-0.59) without significantly affecting all-cause mortality or infection-related mortality. Systemic antibiotic prophylaxis successfully reduced the incidence of infection. However, there was no significant impact on mortality. The clinical benefits of prophylaxis with fluoroquinolones were inconclusive because of the small number of clinical trials evaluated. Copyright © 2014 The British Infection Association. Published by Elsevier Ltd. All rights reserved.

Cost identification of Nordic FLIRI, Nordic FLOX, XELIRI and XELOX in first-line treatment of advanced colorectal cancer in Sweden -- a clinical practice model approach.

PubMed

Pettersson, Karin; Carlsson, Göran; Holmberg, Christoffer; Sporrong, Sofia Kälvemark

2012-09-01

The role of health-related economy is crucial due to the finite healthcare resources. Intravenous (i.v.) regimes Nordic FLOX and Nordic FLIRI, and the partly oral alternatives XELIRI and XELOX are four commonly used chemotherapies in the first-line treatment of advanced colorectal cancer (CRC) in the Scandinavian countries, all with different costs. To describe and compare costs associated with four commonly used treatments for advanced CRC in clinical routine practice. An additional aim was to evaluate the theoretical cost impact of adverse effects associated with the therapies. The retrospective study was carried out using observations and a clinical quality database of CRC patients treated with Nordic FLOX, Nordic FLIRI, XELIRI and XELOX as first line at an oncology clinic in Gothenburg, Sweden. The treatments are used in parallel in clinical practice. All patients treated from 2003 to 2009 were included. The clinical outcome of the therapies was equivalent; mean treatment time was 5.9-7.7 months. A clinical economic evaluation model was designed. All direct costs associated with the baseline treatment, administration of chemotherapy and drug costs were collected and evaluated. The maximum cost for the four treatments was estimated to be 72 000-75 000 SEK per patient for six months, of this approximately 8000 SEK was linked to treatment of toxicity. During six months the i.v. treatments could include 17 more outpatient visits per patient compared to the oral alternatives. During treatment at the clinic around 20% of the patients were hospitalised (XELOX excluded, because of few included patients). The results indicate that the four regimens are similar in terms of treatment costs. Different costs affect the total cost. The oral alternative makes it possible to treat additional patients with the same labour force resources. Treatment of adverse effects contributes to extensive resource use at the hospital.

One year comparative clinical evaluation of EQUIA with resin-modified glass ionomer and a nanohybrid composite in noncarious cervical lesions

PubMed Central

Vaid, Deepa Sunil; Shah, Nimisha Chinmay; Bilgi, Priyanka Shripad

2015-01-01

Aims: Comparative evaluation of EQUIA with a resin-modified glass ionomer cement (RMGIC; GC Gold Label glass ionomer light cured universal restorative cement) and a nanohybrid composite (Tetric N-Ceram) in noncarious cervical lesions (NCCLs). Background: To establish the most suitable material for the restoration of NCCLs. Settings and Design: In vivo study. Materials and Methods: Eighty-seven NCCLs were randomly restored with EQUIA, a RMGIC, and a nanohybrid composite. Clinical evaluation of the restorations was done following the Unites States Public Health criteria by a single-blinded investigator. Data were formulated, and statistical analysis was done by Chi-square test. Statistical Analysis Used: Chi-square test. Results: No significant difference was found between EQUIA, RMGIC, and nanohybrid composite at 1-month, at 6 months, and at 1-year (P > 0.05). Conclusions: EQUIA, resin-modified glass ionomer, and nanohybrid composite performed equally at 1-month, 6 months, and 1-year follow-up periods. PMID:26752837

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.

Post-deployment usability evaluation of a radiology workstation.

PubMed

Jorritsma, Wiard; Cnossen, Fokie; Dierckx, Rudi A; Oudkerk, Matthijs; Van Ooijen, Peter M A

2016-01-01

To determine the number, nature and severity of usability issues radiologists encounter while using a commercially available radiology workstation in clinical practice, and to assess how well the results of a pre-deployment usability evaluation of this workstation generalize to clinical practice. The usability evaluation consisted of semi-structured interviews and observations of twelve users using the workstation during their daily work. Usability issues and positive usability findings were documented. Each issue was given a severity rating and its root cause was determined. Results were compared to the results of a pre-deployment usability evaluation of the same workstation. Ninety-two usability issues were identified, ranging from issues that cause minor frustration or delay, to issues that cause significant delays, prevent users from completing tasks, or even pose a potential threat to patient safety. The results of the pre-deployment usability evaluation had limited generalizability to clinical practice. This study showed that radiologists encountered a large number and a wide variety of usability issues when using a commercially available radiology workstation in clinical practice. This underlines the need for effective usability engineering in radiology. Given the limitations of pre-deployment usability evaluation in radiology, which were confirmed by our finding that the results of a pre-deployment usability evaluation of this workstation had limited generalizability to clinical practice, it is vital that radiology workstation vendors devote significant resources to usability engineering efforts before deployment of their workstation, and to continue these efforts after the workstation is deployed in a hospital. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Evaluating online continuing medical education seminars: evidence for improving clinical practices.

PubMed

Weston, Christine M; Sciamanna, Christopher N; Nash, David B

2008-01-01

The purpose of this study was to evaluate the potential for online continuing medical education (CME) seminars to improve quality of care. Primary care physicians (113) participated in a randomized controlled trial to evaluate an online CME series. Physicians were randomized to view either a seminar about type 2 diabetes or a seminar about systolic heart failure. Following the seminar, physicians were presented with 4 clinical vignettes and asked to describe what tests, treatments, counseling, or referrals they would recommend. Physicians who viewed the seminars were significantly more likely to recommend guideline-consistent care to patients in the vignettes. For example, physicians who viewed the diabetes seminar were significantly more likely to order an eye exam for diabetes patients (63%) compared with physicians in the control group (27%). For some guidelines there were no group differences. These results provide early evidence of the effectiveness of online CME programs to improve physician clinical practice.

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

The use of the functional independence measure in elderly.

PubMed

Ribeiro, Dâmarys Kohlbeck de Melo Neu; Lenardt, Maria Helena; Lourenço, Tânia Maria; Betiolli, Susanne Elero; Seima, Marcia Daniele; Guimarães, Carlos Alberto

2018-06-07

To analyze in scientific publications how the Functional Independence Measure (FIM) has been employed to evaluate the elderly. Integrative review of periodical publications between 2011 and 2015, available online in full-text in Portuguese, English and Spanish. 129 articles were found; after the application of the criteria, they resulted in 21. The studies were categorized into two groups: A) follow or compare scores in FIM (cohort studies, case-control, clinical trials), focusing on rehabilitation, evaluation of programs and changes in the functional level after procedures/interventions; and B) measure/associate the functionality of the elderly (cross-sectional studies), focused on evaluation protocols in elderly health and associations to the caregiver burden, hospital stay, balance, satisfaction with life, cognition and clinical/socio-demographic aspects. The FIM was used in several scenarios of healthcare for the elderly, particularly in rehabilitation and outpatient clinics or health centers.

Evaluating Malaria Prevalence Using Clinical Diagnosis Compared with Microscopy and Rapid Diagnostic Tests in a Tertiary Healthcare Facility in Rivers State, Nigeria.

PubMed

Wogu, M N; Nduka, F O

2018-01-01

The World Health Organization's policy on laboratory test of all suspected malaria cases before treatment has not yielded significant effects in several rural areas of Sub-Saharan Africa due to inadequate diagnostic infrastructure, leading to high morbidity and mortality rates. A cross-sectional randomized study was conducted to evaluate the validity of clinical malaria diagnosis through comparison with microscopy and rapid diagnostic test kits (RDTs) using 1000 consenting outpatients of a tertiary hospital in Nigeria. Physicians conducted clinical diagnosis, and blood samples were collected through venous procedure and analyzed for malaria parasites using Giemsa microscopy and RDT kits. Microscopy was considered the diagnostic "gold standard" and all data obtained were statistically analyzed using Chi-square test with a P value <0.05 considered significant. Malaria prevalence values of 20.1%, 43.1%, and 29.7% were obtained for clinical diagnosis, microscopy, and RDTs, respectively ( P < 0.05). Values of 47.2%, 95.9%, and 77.8% were obtained for sensitivity, specificity, and diagnostic accuracy, respectively, in clinical diagnosis, while RDTs had sensitivity, specificity, and diagnostic accuracy values of 73.7%, 97.3%, and 88.3%, respectively, when compared to microscopy ( P < 0.05). Clinical diagnosed malaria cases should be confirmed with a parasite-based laboratory diagnosis and more qualitative research is needed to explore why clinicians still use clinical diagnosis despite reported cases of its ineffectiveness.

[Analysis of Applying Chinese Medical Clinical Pathway for Treating Attention-deficit Hyperactivity Disorder].

PubMed

Guo, Yu-qing; Han, Xin-min; Zhu, Xian-kang; Zhou, Zheng; Ma, Bing-xiang; Zhang, Bao-qing; Li, Yan-ning; Feng, Yu-lin; Xue, Zheng; Wang, Yong-hong; Li, Yi-min; Jiang, Zhi-mei; Xu, Jin-xing; Yue, Wei-zhen; Xiang, Xi-xiong

2015-12-01

To evaluate the application effect of Chinese medical clinical pathway for treating attention-deficit hyperactivity disorder (ADHD), and to provide evidence for further improving clinical pathways. Totally 270 ADHD children patients were recruited and treated at pediatrics clinics of 9 cooperative hospitals from December 2011 to December 2012. The treatment course for all was 3 months. Scores of attention deficit and hyperactivity rating scale, scores of behavior, Conners index of hyperactivity (CIH), and Chinese medical syndrome scores were compared between before and after treatment. The efficacy difference in various sexes, ages, and disease courses were evaluated by judging standards for Chinese medical syndrome and ADHD. Fifteen children patients who entered clinical pathway dropped out, and the rest 255 completed this trial. Compared with before treatment, total scores of attention deficit and hyperactivity rating scale, scores of attention deficit and hyperactivity rating scale, CIH, and Chinese medical syndrome scores obviously decreased (all P < 0.01). The total effective rate in disease efficacy was 87.8% (224/255 cases), and the total effective rate in Chinese medical syndrome curative effect was 87.5% (223/255 cases). The clinical curative effect was not influenced by age, gender, or course of disease when statistically analyzed from judging standards for Chinese medical syndrome or for disease efficacy. Intervention by Chinese medical clinical pathway could improve ADHD patients' symptoms, and its efficacy was not influenced by sex, age, or course of disease.

A New Wrist Clinical Evaluation Score.

PubMed

Herzberg, Guillaume; Burnier, Marion; Nakamura, Toshiyasu

2018-04-01

Background  The number of available wrist scoring systems is limited; some of them do not include forearm rotation criteria. Purpose  To describe a new electronic wrist clinical score and to present a new patient's generated wrist evaluation criterion, the subjective wrist value (SWV). Materials and Methods  A new electronic wrist clinical score, the Lyon wrist score (LWS) including wrist VAS pain and function, active range of motion and strength was built into an excel file. VAS flexion-extension pain and function were evaluated independently from pronation-supination pain and function. A new patient's generated wrist evaluation criterion, SWV was described. Results  The LWS is available in two versions, standard and full (the latter including forearm rotation strength). Both standard and full LWS are displayed into an automatically generated diamond-shaped graph providing a comprehensive visual display of the clinical status of most osteoarticular wrist disorders. The graph also includes SWV. The LWS, combined with SWV into a graph that may be directly exported to a PowerPoint presentation, provide a new practical and comprehensive tool for following/comparing wrist osteoarticular clinical status/outcomes. Both standard and full LWS charts are available in colored versions on a related website for free download. Conclusion  A comprehensive updated electronic display of osteoarticular wrist clinical status including forearm rotation criteria is provided and displayed into a graph which may be exported as such into a PowerPoint presentation for clinical analysis/comparisons. Level of Evidence  Level II.

Evaluation of an Instructional Model to Teach Clinically Relevant Medicinal Chemistry in a Campus and a Distance Pathway

PubMed Central

Galt, Kimberly A.

2008-01-01

Objectives To evaluate an instructional model for teaching clinically relevant medicinal chemistry. Methods An instructional model that uses Bloom's cognitive and Krathwohl's affective taxonomy, published and tested concepts in teaching medicinal chemistry, and active learning strategies, was introduced in the medicinal chemistry courses for second-professional year (P2) doctor of pharmacy (PharmD) students (campus and distance) in the 2005-2006 academic year. Student learning and the overall effectiveness of the instructional model were assessed. Student performance after introducing the instructional model was compared to that in prior years. Results Student performance on course examinations improved compared to previous years. Students expressed overall enthusiasm about the course and better understood the value of medicinal chemistry to clinical practice. Conclusion The explicit integration of the cognitive and affective learning objectives improved student performance, student ability to apply medicinal chemistry to clinical practice, and student attitude towards the discipline. Testing this instructional model provided validation to this theoretical framework. The model is effective for both our campus and distance-students. This instructional model may also have broad-based applications to other science courses. PMID:18483599

Facial and extrafacial eosinophilic pustular folliculitis: a clinical and histopathological comparative study.

PubMed

Lee, W J; Won, K H; Won, C H; Chang, S E; Choi, J H; Moon, K C; Lee, M W

2014-05-01

Although more than 300 cases of eosinophilic pustular folliculitis (EPF) have been reported to date, differences in clinicohistopathological findings among affected sites have not yet been evaluated. To evaluate differences in the clinical and histopathological features of facial and extrafacial EPF. Forty-six patients diagnosed with EPF were classified into those with facial and extrafacial disease according to the affected site. Clinical and histopathological characteristics were retrospectively compared, using all data available in the patient medical records. There were no significant between-group differences in subject ages at presentation, but a male predominance was observed in the extrafacial group. In addition, immunosuppression-associated type EPF was more common in the extrafacial group. Eruptions of plaques with an annular appearance were more common in the facial group. Histologically, perifollicular infiltration of eosinophils occurred more frequently in the facial group, whereas perivascular patterns occurred more frequently in the extrafacial group. Follicular mucinosis and exocytosis of inflammatory cells in the hair follicles were strongly associated with facial EPF. The clinical and histopathological characteristics of patients with facial and extrafacial EPF differ, suggesting the involvement of different pathogenic processes in the development of EPF at different sites. © 2013 British Association of Dermatologists.

Outcomes of clinical trial: tinnitus masking versus tinnitus retraining therapy.

PubMed

Henry, James A; Schechter, Martin A; Zaugg, Tara L; Griest, Susan; Jastreboff, Pawel J; Vernon, Jack A; Kaelin, Christine; Meikle, Mary B; Lyons, Karen S; Stewart, Barbara J

2006-02-01

A controlled clinical study was conducted to evaluate prospectively the clinical efficacy of tinnitus masking (TM) and tinnitus retraining therapy (TRT) in military veterans having clinically significant tinnitus. Qualifying patients were placed into the two groups in an alternating manner (to avoid selection bias), and treatment was administered at 0, 3, 6, 12, and 18 months. Outcomes of treatment were evaluated using three self-administered tinnitus questionnaires (Tinnitus Handicap Inventory, Tinnitus Handicap Questionnaire, Tinnitus Severity Index) and the verbally administered TRT interview forms. Findings are presented from the three written questionnaires, and from two of the interview questions (percentage time aware of, and annoyed by, tinnitus). Outcomes were analyzed on an intent-to-treat basis, using a multilevel modeling approach. Of the 123 patients enrolled, 118 were included in the analysis. Both groups showed significant declines (improvements) on these measures, with the TRT decline being significantly greater than for TM. The greater declines in TRT compared to TM occurred most strongly in patients who began treatment with a "very big" tinnitus problem. When patients began treatment with a "moderate" tinnitus problem, the benefits of TRT compared to TM were more modest.

Evaluation of the measurement model and clinically important differences for menopause-specific quality of life associated with bazedoxifene/conjugated estrogens.

PubMed

Bushmakin, Andrew G; Abraham, Lucy; Pinkerton, JoAnn V; Cappelleri, Joseph C; Mirkin, Sebastian

2014-08-01

This study aims to confirm the factor structure of the Menopause-Specific Quality of Life (MENQOL) questionnaire by using confirmatory factor analysis (CFA) and to determine whether improvements in menopause-specific health-related quality of life (HRQOL) observed with bazedoxifene (BZA)/conjugated estrogens (CE) relative to placebo are clinically meaningful. Postmenopausal women with seven or more moderate to severe hot flushes per day (or ≥50 per wk) received BZA 20 mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, or placebo for 12 weeks. HRQOL and treatment satisfaction were evaluated using the MENQOL questionnaire and the Menopause Symptoms Treatment Satisfaction Questionnaire, respectively. The structure of the MENQOL questionnaire was evaluated using CFA. To estimate clinically important differences (CIDs) in HRQOL, we used a repeated-measures model to estimate changes in MENQOL domain and total scores using Menopause Symptoms Treatment Satisfaction Questionnaire items as anchors. The CFA model fits the MENQOL data (Bentler's comparative fit index >0.9). CID estimates ranged from 0.5 to 1.2 for the MENQOL domains and total score. Change from baseline in MENQOL vasomotor domain score for BZA 20 mg/CE 0.45 mg and BZA 20 mg/CE 0.625 mg compared with placebo was greater than the estimated CID, as were changes in MENQOL physical domain and total scores for BZA 20 mg/CE 0.625 mg compared with placebo. CFA confirms the factor structure of the MENQOL questionnaire. Treatment with BZA/CE provides clinically meaningful improvements in HRQOL in a population of postmenopausal women with bothersome vasomotor symptoms.

Antiseptic mouth rinses: an update on comparative effectiveness, risks and recommendations.

PubMed

Osso, Diane; Kanani, Nehal

2013-02-01

Antiseptic mouth rinses are widely recommended and marketed to improve oral health. This article summarizes current studies on the comparative effectiveness of selected antiseptic mouth rinses in controlling plaque and gingivitis, as well as risks associated with daily exposure, including salivary flow rate, oral cancer and wear of composite restorations. Electronic database searches were conducted using Google Scholar and PubMed to identify articles comparing the effectiveness of 4 commercially marketed antiseptic mouth rinses differing in active ingredients (0.12% chlorhexidine gluconate, essential oils (menthol, thymol and eucalyptol) and methyl salicylate, 0.7% cetylpyridinium chloride and 20% aloe vera gel) for controlling plaque and gingivitis. Criteria for inclusion included controlled clinical trials and systematic reviews appearing in English language publications evaluating the comparative effectiveness of the mouth rinses in controlling plaque and gingivitis, as well as risks associated with daily usage. The majority of studies have shown mouth rinses containing chlorhexidine gluconate or essential oils and methyl salicylate provide clinically significant anti-gingivitis and anti-plaque benefits. Cetylpyridinium chloride has been found to provide only limited clinical benefits compared to inactive control mouth rinse. Inadequate evidence is available to evaluate the clinical effectiveness of aloe vera gel. Chlorhexidine, essential oils and cetylpyridinium have been found to be safe. However, limited data are available on the effects of the mouth rinse on wear patterns of dental restorations. Studies reviewed reported no significant difference in salivary flow rate related to alcohol based mouth rinse. Research supports the effectiveness of antiseptic mouth rinses in reducing plaque and gingivitis as an adjunct to home care. Insufficient evidence is available to support the claim that oral antiseptics can reduce the risk of developing periodontitis or the rate of progression of periodontitis.

Performance evaluation of the HepB Typer-Entecavir kit for detection of entecavir resistance mutations in chronic hepatitis B.

PubMed

Ahn, Sang Hoon; Chun, Ji-Yong; Shin, Soo-Kyung; Park, Jun Yong; Yoo, Wangdon; Hong, Sun Pyo; Kim, Soo-Ok; Han, Kwang-Hyub

2013-12-01

Molecular diagnostic methods have enabled the rapid diagnosis of drug-resistant mutations in hepatitis B virus (HBV) and have reduced both unnecessary therapeutic interventions and medical costs. In this study we evaluated the analytical and clinical performances of the HepB Typer-Entecavir kit (GeneMatrix, Korea) in detecting entecavir-resistance-associated mutations. The HepB Typer-Entecavir kit was evaluated for its limit of detection, interference, cross-reactivity, and precision using HBV reference standards made by diluting high-titer viral stocks in HBV-negative human serum. The performance of the HepB Typer-Entecavir kit for detecting mutations related to entecavir resistance was compared with direct sequencing for 396 clinical samples from 108 patients. Using the reference standards, the detection limit of the HepB Typer-Entecavir kit was found to be as low as 500 copies/mL. No cross-reactivity was observed, and elevated levels of various interfering substances did not adversely affect its analytical performance. The precision test conducted by repetitive analysis of 2,400 replicates with reference standards at various concentrations showed 99.9% agreement (2398/2400). The overall concordance rate between the HepB Typer-Entecavir kit and direct sequencing assays in 396 clinical samples was 99.5%. The HepB Typer-Entecavir kit showed high reliability and precision, and comparable sensitivity and specificity for detecting mutant virus populations in reference and clinical samples in comparison with direct sequencing. Therefore, this assay would be clinically useful in the diagnosis of entecavir-resistance-associated mutations in chronic hepatitis B.

Connecting clinical and actuarial prediction with rule-based methods.

PubMed

Fokkema, Marjolein; Smits, Niels; Kelderman, Henk; Penninx, Brenda W J H

2015-06-01

Meta-analyses comparing the accuracy of clinical versus actuarial prediction have shown actuarial methods to outperform clinical methods, on average. However, actuarial methods are still not widely used in clinical practice, and there has been a call for the development of actuarial prediction methods for clinical practice. We argue that rule-based methods may be more useful than the linear main effect models usually employed in prediction studies, from a data and decision analytic as well as a practical perspective. In addition, decision rules derived with rule-based methods can be represented as fast and frugal trees, which, unlike main effects models, can be used in a sequential fashion, reducing the number of cues that have to be evaluated before making a prediction. We illustrate the usability of rule-based methods by applying RuleFit, an algorithm for deriving decision rules for classification and regression problems, to a dataset on prediction of the course of depressive and anxiety disorders from Penninx et al. (2011). The RuleFit algorithm provided a model consisting of 2 simple decision rules, requiring evaluation of only 2 to 4 cues. Predictive accuracy of the 2-rule model was very similar to that of a logistic regression model incorporating 20 predictor variables, originally applied to the dataset. In addition, the 2-rule model required, on average, evaluation of only 3 cues. Therefore, the RuleFit algorithm appears to be a promising method for creating decision tools that are less time consuming and easier to apply in psychological practice, and with accuracy comparable to traditional actuarial methods. (c) 2015 APA, all rights reserved).

Analytical evaluation of point of care cTnT and clinical performances in an unselected population as compared with central laboratory highly sensitive cTnT.

PubMed

Dupuy, Anne Marie; Sebbane, Mustapha; Roubille, François; Coste, Thibault; Bargnoux, Anne Sophie; Badiou, Stéphanie; Kuster, Nils; Cristol, Jean Paul

2015-03-01

To report the analytical performances of the Radiometer AQT90 FLEX® cTnT assay (Neuilly-Plaisance, France) and to evaluate the concordance with hs-cTnT results from central laboratory for the diagnosis of acute myocardial infarction (AMI) at baseline and during a short follow-up among unselected patients admitted in emergency room or cardiology department. Analytical performances of AQT90 FLEX® cTnT immunoassay included imprecision study with determination of a coefficient of variation at 10% and 20%, linearity, and limit of detection. The concordance study was based on samples obtained from 170 consecutive patients with chest pain suggestive of acute coronary syndrome (ACS) admitted in the emergency room or cardiology department. The kinetic study (within 62 additional samples 3h later) was based on absolute delta criterion and the combination of relative change of 30% with absolute change of 7ng/L. The cTnT assay from Radiometer was evaluated as clinically usable, although less sensitive than the Roche hs-cTnT assay as demonstrated by the concordance and the kinetic studies. In non-selected population, the cTnT AQT Flex© assay on AQT90© with kinetic change at 3h, provides similar clinical classification of patients, particularly for AMI group as compared to central laboratory hs-cTnT assay and could be suitable for clinical use. Copyright © 2014 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Has platelet-rich plasma any role in anterior cruciate ligament allograft healing?

PubMed

Nin, Juan Ramón Valentí; Gasque, Gonzalo Mora; Azcárate, Andrés Valentí; Beola, Jesús Dámaso Aquerreta; Gonzalez, Milagros Hernandez

2009-11-01

The aim of this study was to evaluate and compare the clinical and inflammatory parameters with the addition of platelet-derived growth factor (PDGF) in primary anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone allograft. We prospectively randomized 100 patients undergoing arthroscopic patellar tendon allograft ACL reconstruction to a group in whom platelet-enriched gel was used (n = 50) and a non-gel group (n = 50). The platelet concentration was 837 x 10(3)/mm(3), and the gel was introduced inside the graft and the tibial tunnel. Demographic data were comparable between groups. The mean follow-up was 24 months for both groups and included a history, clinical evaluation with the International Knee Documentation Committee score, radiographs, and magnetic resonance imaging. There were no differences in the number of associated injuries. The results did not show any statistically significant differences between the groups for inflammatory parameters (perimeters of the knee and C-reactive protein level), magnetic resonance imaging appearance of the graft, and clinical evaluation scores (visual analog scale, International Knee Documentation Committee, and KT-1000 arthrometer [MEDmetric, San Diego, CA]). At this time, the therapeutic role of PDGF in ACL reconstruction remains unclear. The use of PDGF, on the graft and inside the tibial tunnel, in patients treated with bone-patellar tendon-bone allografts has no discernable clinical or biomechanical effect at 2 years' follow-up. More clinical studies will be needed to show the efficacy and use of these factors in daily practice in ACL reconstruction. Level I, prospective, randomized, double-blind study.

18 F-Fluorodeoxyglucose-Positron Emission Tomography As an Imaging Biomarker in a Prospective, Longitudinal Cohort of Patients With Large Vessel Vasculitis.

PubMed

Grayson, Peter C; Alehashemi, Sara; Bagheri, Armin A; Civelek, Ali Cahid; Cupps, Thomas R; Kaplan, Mariana J; Malayeri, Ashkan A; Merkel, Peter A; Novakovich, Elaine; Bluemke, David A; Ahlman, Mark A

2018-03-01

To assess the clinical value of 18 F-fluorodeoxyglucose (FDG) positron emission tomography (PET) in a prospective cohort of patients with large vessel vasculitis (LVV) and comparator subjects. Patients with Takayasu arteritis and giant cell arteritis were studied, along with a comparator group consisting of patients with hyperlipidemia, patients with diseases that mimic LVV, and healthy controls. Participants underwent clinical evaluation and FDG-PET imaging, and patients with LVV underwent serial imaging at 6-month intervals. We calculated sensitivity and specificity of FDG-PET interpretation for distinguishing patients with clinically active LVV from comparator subjects and from patients with disease in clinical remission. A qualitative summary score based on global arterial FDG uptake, the PET Vascular Activity Score (PETVAS), was used to study associations between activity on PET scan and clinical characteristics and to predict relapse. A total of 170 FDG-PET scans were performed in 115 participants (56 patients with LVV and 59 comparator subjects). FDG-PET distinguished patients with clinically active LVV from comparator subjects with a sensitivity of 85% (95% confidence interval [95% CI] 69, 94) and a specificity of 83% (95% CI 71, 91). FDG-PET scans were interpreted as active vasculitis in most patients with LVV in clinical remission (41 of 71 [58%]). Clinical disease activity status, disease duration, body mass index, and glucocorticoid use were independently associated with activity on PET scan. Among patients who underwent PET during clinical remission, future clinical relapse was more common in patients with a high PETVAS than in those with a low PETVAS (55% versus 11%; P = 0.03) over a median follow-up period of 15 months. FDG-PET provides information about vascular inflammation that is complementary to, and distinct from, clinical assessment in LVV. FDG-PET scan activity during clinical remission was associated with future clinical relapse. © 2017, American College of Rheumatology.

Effects of a digital clinical pathway for elective electrocardioversion for atrial fibrillation on quality of care.

PubMed

Valente, Mattia; Zwaan, Esther; Wit, Mirjam; Kimman, Geert P; Umans, Victor

2010-12-01

Clinical pathways attempt to increase efficiency by organizing the care-delivery process into individual analyzable steps. However, full advantage may only be taken if the process is governed by a "process care taker." Currently, new opportunities are emerging for nurses to become involved as health care experts and may become an intermediate between patient and clinical team. We evaluate a digital clinical pathway for electrocardioversion in atrial fibrillation with a nurse-coordinator in the ongoing consecutive experience in clinical practice. The introduction of a digital pathway into the hospital information system allows continuous surveillance of clinical outcome indicators as well as variance indicators. This article describes a service evaluation and the implementation and effects of introducing a clinical pathway. However, when comparing the 2 eras, the primary goals were improved guideline-adherence and reduced walk-through times in the 600 consecutive pathway patients versus 100 consecutive control patients. The pathway was launched in January 2008. Up to January 2009, 600 all-comer, elective patients were treated using this integrated digital clinical pathway, without exception. Treatment and outpatient check-up appointments are made immediately for all patients. The pathway enabled the cardiologist to complete the risk calculator and drug therapy recommendations significantly better when compared with control patients and also reduced walk-through times significantly. Patient satisfaction rose from 8.7 to 9.1 (P < 0.01) using the pathway. A nurse-led clinical pathway for cardioversion patients is safely and efficaciously introduced in a teaching hospital. The pathway improved guideline-adherence. These results emphasize the importance of a nurse-coordinator who is an intermediary between atrial fibrillation patients and the clinical care team.

Predicting inpatient clinical order patterns with probabilistic topic models vs conventional order sets

PubMed Central

Goldstein, Mary K; Asch, Steven M; Mackey, Lester; Altman, Russ B

2017-01-01

Objective: 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. Materials and Methods: 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. Results: 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”). Discussion: 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. Conclusion: 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. PMID:27655861

Chinese SLE Treatment and Research group (CSTAR) registry: I. Major clinical characteristics of Chinese patients with systemic lupus erythematosus.

PubMed

Li, M; Zhang, W; Leng, X; Li, Z; Ye, Z; Li, C; Li, X; Zhu, P; Wang, Z; Zheng, Y; Li, X; Zhang, M; Zhang, F; Zhao, Y; Zeng, X

2013-10-01

The Chinese systemic lupus erythematosus (SLE) treatment and research group (CSTAR) provides major clinical characteristics of SLE in China and establishes a platform to provide resources for future basic and clinical studies. CSTAR originated as a multicentre, consecutive, and prospective design. The data were collected online from 104 rheumatology centers, which covered 30 provinces in China. The registered patients were required to meet four or more of the American College of Rheumatology (ACR) criteria for the classification of SLE. All CSTAR centers use the same protocol-directed methods to provide uniform evaluations, which included demographic data, clinical features, laboratory examinations, and disease activity evaluations. The patient samples, including DNA samples and sera, were also collected for further quality controls and additional studies. Preliminary analysis from 2104 baseline evaluations was available for this analysis. Of 1914 female and 190 male patients (F:M=10.1), the mean age at onset was 29.2 y with confirmed diagnosis one year later at the age of 30.3 y. Eighty four (4.2%) of 2002 patients had a family history of rheumatic diseases, including 34 (1.7%) cases with SLE. In addition, one hundred and seven (5.2%) abnormal pregnancies were recorded among 2026 experiences. The characteristics of the CSTAR cohort were compared to similarly sized cohorts from other studies. We found that 56.1% of patients presented with concurrent hematological disorders compared to only 18.2% of European patients. Moreover, 47.4% of patients presented with nephropathy compared to 27.9% of European patients. Conversely, neurological manifestations were only seen in 4.8% of Chinese SLE patients compared to 19.4% of European patients, 12.1% of U.S. patients, 22.8% of Malaysian patients and 26.4% of Latin Americans. Pulmonary arterial hypertension and interstitial lung diseases were complications identified in 3.8% and 4.2% of Chinese lupus patients, respectively. The CSTAR registry has provided epidemiological data and phenotypes of Chinese patients with SLE, and has demonstrated several differences between ethnicities. Clinical data and biologic samples would be valuable resources for future translational studies with national and international collaboration.

Laboratory Evaluation of the Liat HIV Quant (IQuum) Whole-Blood and Plasma HIV-1 Viral Load Assays for Point-of-Care Testing in South Africa

PubMed Central

Gous, Natasha; Carmona, Sergio; Stevens, Wendy

2015-01-01

Point-of-care (POC) HIV viral load (VL) testing offers the potential to reduce turnaround times for antiretroviral therapy monitoring, offer near-patient acute HIV diagnosis in adults, extend existing centralized VL services, screen women in labor, and prompt pediatrics to early treatment. The Liat HIV Quant plasma and whole-blood assays, prerelease version, were evaluated in South Africa. The precision, accuracy, linearity, and agreement of the Liat HIV Quant whole-blood and plasma assays were compared to those of reference technologies (Roche CAP CTMv2.0 and Abbott RealTime HIV-1) on an HIV verification plasma panel (n = 42) and HIV clinical specimens (n = 163). HIV Quant plasma assay showed good performance, with a 2.7% similarity coefficient of variation (CV) compared to the Abbott assay and a 1.8% similarity CV compared to the Roche test on the verification panel, and 100% specificity. HIV Quant plasma had substantial agreement (pc [concordance correlation] = 0.96) with Roche on clinical specimens and increased variability (pc = 0.73) in the range of <3.0 log copies/ml range with the HIV Quant whole-blood assay. HIV Quant plasma assay had good linearity (2.0 to 5.0 log copies/ml; R2 = 0.99). Clinical sensitivity at a viral load of 1,000 copies/ml of the HIV Quant plasma and whole-blood assays compared to that of the Roche assay (n = 94) was 100% (confidence interval [CI], 95.3% to 100%). The specificity of HIV Quant plasma was 88.2% (CI, 63.6% to 98.5%), and that for whole blood was 41.2% (CI, 18.4% to 67.1%). No virological failure (downward misclassification) was missed. Liat HIV Quant plasma assay can be interchanged with existing VL technology in South Africa. Liat HIV Quant whole-blood assay would be advantageous for POC early infant diagnosis at birth and adult adherence monitoring and needs to be evaluated further in this clinical context. LIAT cartridges currently require cold storage, but the technology is user-friendly and robust. Clinical cost and implementation modeling is required. PMID:25740777

Reliability of gadolinium-enhanced magnetic resonance imaging findings and their correlation with clinical outcome in patients with sciatica.

PubMed

el Barzouhi, Abdelilah; Vleggeert-Lankamp, Carmen L A M; Lycklama à Nijeholt, Geert J; Van der Kallen, Bas F; van den Hout, Wilbert B; Koes, Bart W; Peul, Wilco C

2014-11-01

Gadolinium-enhanced magnetic resonance imaging (Gd-MRI) is often performed in the evaluation of patients with persistent sciatica after lumbar disc surgery. However, correlation between enhancement and clinical findings is debated, and limited data are available regarding the reliability of enhancement findings. To evaluate the reliability of Gd-MRI findings and their correlation with clinical findings in patients with sciatica. Prospective observational evaluation of patients who were enrolled in a randomized trial with 1-year follow-up. Patients with 6- to 12-week sciatica, who participated in a multicentre randomized clinical trial comparing an early surgery strategy with prolonged conservative care with surgery if needed. In total 204 patients underwent Gd-MRI at baseline and after 1 year. Patients were assessed by means of the Roland Disability Questionnaire (RDQ) for sciatica, visual analog scale (VAS) for leg pain, and patient-reported perceived recovery at 1 year. Kappa coefficients were used to assess interobserver reliability. In total, 204 patients underwent Gd-MRI at baseline and after 1 year. Magnetic resonance imaging findings were correlated to the outcome measures using the Mann-Whitney U test for continuous data and Fisher exact tests for categorical data. Poor-to-moderate agreement was observed regarding Gd enhancement of the herniated disc and compressed nerve root (kappa<0.41), which was in contrast with excellent interobserver agreement of the disc level of the herniated disc and compressed nerve root (kappa>0.95). Of the 59 patients with an enhancing herniated disc at 1 year, 86% reported recovery compared with 100% of the 12 patients with nonenhancing herniated discs (p=.34). Of the 12 patients with enhancement of the most affected nerve root at 1 year, 83% reported recovery compared with 85% of the 192 patients with no enhancement (p=.69). Patients with and without enhancing herniated discs or nerve roots at 1 year reported comparable outcomes on RDQ and VAS-leg pain. Reliability of Gd-MRI findings was poor-to-moderate and no correlation was observed between enhancement and clinical findings at 1-year follow-up. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparing the effectiveness of ultrasound-guided versus blind steroid injection in the treatment of severe carpal tunnel syndrome

PubMed

Karaahmet, Özgür Zeliha; Gürçay, Eda; Kara, Murat; Serçe, Azize; Kıraç Ünal, Zeynep; Çakcı, Aytül

2017-12-19

Background/aim: This study aimed to compare the effectiveness of ultrasound (US)-guided injection versus blind injection of corticosteroids in the treatment of carpal tunnel syndrome (CTS). Materials and methods: This prospective, randomized clinical trial included patients with severe CTS based on clinical and electrophysiological criteria. The patients were evaluated for clinical and electrophysiological parameters at baseline and 4 weeks after treatment. Symptom severity and hand function were assessed by the Boston questionnaire. The patients underwent blind injection or US-guided injection. Results: When compared with baseline, both groups showed significant improvement in Boston questionnaire scores and all electrophysiological parameters. Significant differences were observed between the groups for clinical parameters (Boston Symptom Severity Scale: P = 0.007; Functional Status Scale: P < 0.001) in favor of the US-guided group. Conclusion: This study demonstrated that both US-guided and blind injections were effective in reducing symptoms and improving hand function. US-guided injections may yield more effective clinical results in the short-term than blind injections in the treatment of patients with severe CTS.

The factor structure and psychometric properties of the Clinical Outcomes in Routine Evaluation – Outcome Measure (CORE-OM) in Norwegian clinical and non-clinical samples

PubMed Central

2013-01-01

Background The Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) is a 34-item instrument developed to monitor clinically significant change in out-patients. The CORE-OM covers four domains: well-being, problems/symptoms, functioning and risk, and sums up in two total scores: the mean of All items, and the mean of All non-risk items. The aim of this study was to examine the psychometric properties of the Norwegian translation of the CORE-OM. Methods A clinical sample of 527 out-patients from North Norwegian specialist psychiatric services, and a non-clinical sample of 464 persons were obtained. The non-clinical sample was a convenience sample consisting of friends and family of health personnel, and of students of medicine and clinical psychology. Students also reported psychological stress. Exploratory factor analysis (EFA) was employed in half the clinical sample. Confirmatory (CFA) factor analyses modelling the theoretical sub-domains were performed in the remaining half of the clinical sample. Internal consistency, means, and gender and age differences were studied by comparing the clinical and non-clinical samples. Stability, effect of language (Norwegian versus English), and of psychological stress was studied in the sub-sample of students. Finally, cut-off scores were calculated, and distributions of scores were compared between clinical and non-clinical samples, and between students reporting stress or no stress. Results The results indicate that the CORE-OM both measures general (g) psychological distress and sub-domains, of which risk of harm separates most clearly from the g factor. Internal consistency, stability and cut-off scores compared well with the original English version. No, or only negligible, language effects were found. Gender differences were only found for the well-being domain in the non-clinical sample and for the risk domain in the clinical sample. Current patient status explained differences between clinical and non-clinical samples, also when gender and age were controlled for. Students reporting psychological distress during last week scored significantly higher than students reporting no stress. These results further validate the recommended cut-off point of 1 between clinical and non-clinical populations. Conclusions The CORE-OM in Norwegian has psychometric properties at the same level as the English original, and could be recommended for general clinical use. A cut-off point of 1 is recommended for both genders. PMID:23521746

Clinical efficacy and safety of polyethylene glycol 3350 versus liquid paraffin in the treatment of pediatric functional constipation

PubMed Central

Rafati, MR.; Karami, H.; Salehifar, E.; Karimzadeh, A.

2011-01-01

Background and the purpose of the study Functional constipation is prevalent in children. Recently polyethylene glycol has been introduced as an effective and safe drug to treat chronic constipation. There are only a few clinical trials on comparison of PEG and liquid paraffin in childhood constipation. The purpose of this study was to evaluate clinical efficacy and safety of PEG 3350 solution and liquid paraffin in the treatment of children with functional constipation in Sari Toba clinic during the period of 2008–2009. Methods Children with a history of functional constipation were subjects of this study. One hundred and sixty children of 2–12 years old with functional constipation were randomized in two PEG and paraffin treatment groups. Patients received either 1.0–1.5 g/kg/day PEG 3350 or 1.0–1.5 ml/kg/day liquid paraffin for 4 months. Clinical efficacy was evaluated by stool and encopresis frequency/week and overall treatment success rate was compared in two groups. Results and major conclusion Compared with the baseline, defecation frequency/ week increased significantly and encopresis frequency meaningfully decreased in two groups during the period of the study. Patients using PEG 3350 had more success rate (mean: 95.3%±3.7) compared with the patients in paraffin group (mean: 87.2%±7.1) (p=0.087). Administration of PEG 3350 were associated with less adverse events than liquid paraffin. In conclusion in treatment of pediatric functional constipation, regarding clinical efficacy and safety, PEG 3350 were at least as effective as liquid paraffin and but less adverse drug events. PMID:22615652

Clinical outcomes of arthroscopic single and double row repair in full thickness rotator cuff tears.

PubMed

Ji, Jong-Hun; Shafi, Mohamed; Kim, Weon-Yoo; Kim, Young-Yul

2010-07-01

There has been a recent interest in the double row repair method for arthroscopic rotator cuff repair following favourable biomechanical results reported by some studies. The purpose of this study was to compare the clinical results of arthroscopic single row and double row repair methods in the full-thickness rotator cuff tears. 22 patients of arthroscopic single row repair (group I) and 25 patients who underwent double row repair (group II) from March 2003 to March 2005 were retrospectively evaluated and compared for the clinical outcomes. The mean age was 58 years and 56 years respectively for group I and II. The average follow-up in the two groups was 24 months. The evaluation was done by using the University of California Los Angeles (UCLA) rating scale and the shoulder index of the American Shoulder and Elbow Surgeons (ASES). In Group I, the mean ASES score increased from 30.48 to 87.40 and the mean ASES score increased from 32.00 to 91.45 in the Group II. The mean UCLA score increased from the preoperative 12.23 to 30.82 in Group I and from 12.20 to 32.40 in Group II. Each method has shown no statistical clinical differences between two methods, but based on the sub scores of UCLA score, the double row repair method yields better results for the strength, and it gives more satisfaction to the patients than the single row repair method. Comparing the two methods, double row repair group showed better clinical results in recovering strength and gave more satisfaction to the patients but no statistical clinical difference was found between 2 methods.

Clinical outcomes of arthroscopic single and double row repair in full thickness rotator cuff tears

PubMed Central

Ji, Jong-Hun; Shafi, Mohamed; Kim, Weon-Yoo; Kim, Young-Yul

2010-01-01

Background: There has been a recent interest in the double row repair method for arthroscopic rotator cuff repair following favourable biomechanical results reported by some studies. The purpose of this study was to compare the clinical results of arthroscopic single row and double row repair methods in the full-thickness rotator cuff tears. Materials and Methods: 22 patients of arthroscopic single row repair (group I) and 25 patients who underwent double row repair (group II) from March 2003 to March 2005 were retrospectively evaluated and compared for the clinical outcomes. The mean age was 58 years and 56 years respectively for group I and II. The average follow-up in the two groups was 24 months. The evaluation was done by using the University of California Los Angeles (UCLA) rating scale and the shoulder index of the American Shoulder and Elbow Surgeons (ASES). Results: In Group I, the mean ASES score increased from 30.48 to 87.40 and the mean ASES score increased from 32.00 to 91.45 in the Group II. The mean UCLA score increased from the preoperative 12.23 to 30.82 in Group I and from 12.20 to 32.40 in Group II. Each method has shown no statistical clinical differences between two methods, but based on the sub scores of UCLA score, the double row repair method yields better results for the strength, and it gives more satisfaction to the patients than the single row repair method. Conclusions: Comparing the two methods, double row repair group showed better clinical results in recovering strength and gave more satisfaction to the patients but no statistical clinical difference was found between 2 methods. PMID:20697485

ACCP: economic evaluations of clinical pharmacy services: 2001-2005.

PubMed

Perez, Alexandra; Doloresco, Fred; Hoffman, James M; Meek, Patrick D; Touchette, Daniel R; Vermeulen, Lee C; Schumock, Glen T

2009-01-01

The objectives of this review were to summarize and evaluate studies that measured the economic impact of clinical pharmacy services published between 2001 and 2005 (inclusive) and to provide guidance on methodologic considerations to individuals performing such research in the future. A systematic literature search using the MEDLINE and International Pharmaceutical Abstracts databases was conducted to identify published economic evaluations of clinical pharmacy services. Studies were screened and then randomly assigned to reviewers, who reassessed inclusion and exclusion criteria and abstracted prespecified data from each study. Among the many characteristics examined in each study were study design and type of economic evaluation, setting and type of clinical pharmacy service, study quality, and results. Ninety-three articles were included in the final analysis. These studies were published in 43 different journals, most of which (68 [73.1%]) were pharmacy-based. Most studies were performed in hospitals (40 [43.0%]), ambulatory care clinics or physician's offices (20 [21.5%]), or community pharmacies (16 [17.2%]). The most common types of clinical pharmacy services evaluated were general pharmacotherapeutic monitoring services (32 [34.4%]), target drug programs (27 [29%]), and disease state-management services (21 [22.6%]). Full economic evaluations were performed in just less than half (45 [48.4%]) of the studies, and a positive economic benefit associated with clinical pharmacy services was noted in 31 (69%) of the 45 studies. Among 15 studies reporting data necessary to determine a benefit:cost ratio, the pooled median value was 4.81:1-meaning that for every $1 invested in clinical pharmacy services, $4.81 was achieved in reduced costs or other economic benefits. The quality of studies varied widely, with less than one half considered to be good to fair (40 [43.0%]); however, the proportion of studies using appropriate study designs increased compared with previous reviews. Based on the evidence examined in this review, clinical pharmacy services continue to provide a significant return on investment, but improvements are still needed in the methods used to evaluate the economic impact of these services.

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.

Planning the Breast Boost: Comparison of Three Techniques and Evolution of Tumor Bed During Treatment

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

Hepel, Jaroslaw T.; Department of Radiation Oncology, Brown University, Rhode Island Hospital, Providence, RI; Evans, Suzanne B.

2009-06-01

Purpose: To evaluate the accuracy of two clinical techniques for electron boost planning compared with computed tomography (CT)-based planning. Additionally, we evaluated the tumor bed characteristics at whole breast planning and boost planning. Methods and Materials: A total of 30 women underwent tumor bed boost planning within 2 weeks of completing whole breast radiotherapy using three planning techniques: scar-based planning, palpation/clinical-based planning, and CT-based planning. The plans were analyzed for dosimetric coverage of the CT-delineated tumor bed. The cavity visualization score was used to define the CT-delineated tumor bed as well or poorly defined. Results: Scar-based planning resulted in inferiormore » tumor bed coverage compared with CT-based planning, with the minimal dose received by 90% of the target volume >90% in 53% and a geographic miss in 53%. The results of palpation/clinical-based planning were significantly better: 87% and 10% for the minimal dose received by 90% of the target volume >90% and geographic miss, respectively. Of the 30 tumor beds, 16 were poorly defined by the cavity visualization score. Of these 16, 8 were well demarcated by the surgical clips. The evaluation of the 22 well-defined tumor beds revealed similar results. A comparison of the tumor bed volume from the initial planning CT scan to the boost planning CT scan revealed a decrease in size in 77% of cases. The mean decrease in volume was 52%. Conclusion: The results of our study have shown that CT-based planning allows for optimal tumor bed coverage compared with clinical and scar-based approaches. However, in the setting of a poorly visualized cavity on CT without surgical clips, palpation/clinical-based planning can help delineate the appropriate target volumes and is superior to scar-based planning. CT simulation at boost planning could allow for a reduction in the boost volumes.« less

Treatment and outcome of out-of-hospital cardiac arrest in outpatient health care facilities.

PubMed

Kudenchuk, Peter J; Stuart, Russell; Husain, Sofia; Fahrenbruch, Carol; Eisenberg, Mickey

2015-12-01

We evaluated the frequency and effectiveness of basic and advanced life support (ALS) interventions by medical professionals when out-of-hospital cardiac arrest (OHCA) occurred in ambulatory healthcare clinics before emergency medical services (EMS) arrival. Non-traumatic OHCAs in adults were systematically characterized over a 15 year period by their occurrence in clinics, at home, or in non-medical public locations, and outcomes compared between matched cohorts from each group. Among 7784 patients, 6098 OHCA occurred at home, 1612 in non-medical public locations and 74 in clinics. Compared to non-medical public locations, clinic patients with OHCA were older, more often women and more frequently shocked; clinic arrests were more often witnessed, less likely to be of cardiac cause and to occur before EMS arrival. Compared to home, more clinic arrests were witnessed, occurred after EMS arrival, had bystander CPR, shockable rhythms and were defibrillated. When OHCA occurred before EMS arrival, 51 of 56 clinic patients (91%) received CPR, a defibrillator applied to 23 (41%), 17 (30%) were shocked, 4 (7%) intubated, and 7 (13%) received intravenous medications from facility personnel. Of these, only pre-EMS defibrillator use was associated with improved outcome. Among matched patients, OHCA survival was higher in clinics than at home (42% vs 26%, p=0.029), but comparable to other public locations. Survival from OHCA in clinics was comparable to non-medical public locations, and higher than at home. Alongside CPR, use of defibrillators was associated with improved survival and worth prioritizing over other interventions before EMS arrival regardless of OHCA location. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

The importance of polysomnography in the evaluation of prolonged disorders of consciousness: sleep recordings more adequately correlate than stimulus-related evoked potentials with patients' clinical status.

PubMed

de Biase, Stefano; Gigli, Gian Luigi; Lorenzut, Simone; Bianconi, Claudio; Sfreddo, Patrizia; Rossato, Gianluca; Basaldella, Federica; Fuccaro, Matteo; Corica, Antonio; Tonon, Davide; Barbone, Fabio; Valente, Mariarosaria

2014-04-01

The aim of our study was to evaluate the importance of sleep recordings and stimulus-related evoked potentials (EPs) in patients with prolonged disorders of consciousness (DOCs) by correlating neurophysiologic variables with clinical evaluation obtained using specific standardized scales. There were 27 vegetative state (VS) and 5 minimally conscious state (MCS) patients who were evaluated from a clinical and neurophysiologic perspective. Clinical evaluation included the Coma Recovery Scale-Revised (CRS-R), Disability Rating Scale (DRS), and Glasgow Coma Scale (GCS). Neurophysiologic evaluation included 24-h polysomnography (PSG), somatosensory EPs (SEPs), brainstem auditory EPs (BAEPs), and visual EPs (VEPs). Patients with preservation of each single sleep element (sleep-wake cycle, sleep spindles, K-complexes, and rapid eye movement [REM] sleep) always showed better clinical scores compared to those who did not have preservation. Statistical significance was only achieved for REM sleep. In 7 patients PSG showed the presence of all considered sleep elements, and they had a CRS-R score of 8.29±1.38. In contrast, 25 patients who lacked one or more of the sleep elements had a CRS-R score of 4.84±1.46 (P<.05). Our multivariate analysis clarified that concurrent presence of sleep spindles and REM sleep were associated with a much higher CRS-R score (positive interaction, P<.0001). On the other hand, no significant associations were found between EPs and CRS-R scores. PSG recordings have proved to be a reliable tool in the neurophysiologic assessment of patients with prolonged DOCs, correlating more adequately than EPs with the clinical evaluation and the level of consciousness. The main contribution to higher clinical scores was determined by the concomitant presence of REM sleep and sleep spindles. PSG recordings may be considered inexpensive, noninvasive, and easy-to-perform examinations to provide supplementary information in patients with prolonged DOCs. Copyright © 2014 Elsevier B.V. All rights reserved.

Randomized noninferiority field trial evaluating cephapirin sodium for treatment of nonsevere clinical mastitis.

PubMed

Tomazi, T; Lopes, T A F; Masson, V; Swinkels, J M; Santos, M V

2018-05-16

The general objective of this study was to evaluate whether cephapirin sodium is noninferior compared with a positive control broad-spectrum product formulated with a combination of antimicrobials for intramammary treatment of nonsevere clinical mastitis. In addition, we compared the efficacy of treatments on the cure risks of pathogen groups (gram-positive, gram-negative, and cultures with no growth) based on culture results. A total of 346 cows distributed in 31 commercial dairy herds were selected to participate in the study, although only 236 met the criteria for evaluation of microbiological cure. Coagulase-negative staphylococci were the most isolated gram-positive pathogens in pretreatment milk samples, whereas the most common gram-negative bacterium was Escherichia coli. Cows attending the postadmission criteria were treated with 4 intramammary infusions (12 h apart) of one of the following antimicrobials: 300 mg of cephapirin sodium + 20 mg of prednisolone (CS), or the positive control treatment formulated with a combination of antimicrobials (200 mg of tetracycline + 250 mg of neomycin + 28 mg of bacitracin + 10 mg of prednisolone; TNB). Noninferiority analysis and mixed regression models (overall and considering the pathogen groups) were performed for the following outcomes: bacteriological cure (absence of the causative pathogens in cultures performed in milk samples collected at 14 and 21 ± 3 d after enrollment), pathogen cure (absence of any pathogen on both follow-up samples), clinical cure (absence of clinical sign in the milk and mammary gland at 48 h after the last antimicrobial infusion), extended clinical cure (normal milk and normal gland on the second posttreatment sample collection (d 21), and linear score of somatic cell count cure [linear score of somatic cell count recovery (≤4.0) on d 21 ± 3 after enrollment]. No significant differences were observed between treatments regarding any of the evaluated outcomes in both regression models (overall and considering the pathogen groups). Noninferiority of CS relative to TNB was inconclusive for bacteriological cure (CS = 0.68; TNB = 0.73) and clinical cure (CS = 0.88; TNB = 0.94), as the confidence intervals crossed the pre-stated margin of noninferiority (Δ = -0.15). Cephapirin sodium was noninferior compared with TNB for pathogen cure (CS = 0.36; TNB = 0.35), extended clinical cure (CS = 0.93; TNB = 0.92), and linear score of somatic cell count cure (CS = 0.29; TNB = 0.28). In conclusion, the use of intramammary CS for treatment of nonsevere clinical mastitis has similar efficacy as a treatment regimen with a combination of antimicrobial agents (tetracycline + neomycin + bacitracin), although noninferiority analysis showed inconclusive results for bacteriological and clinical cures. Copyright © 2018 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Orthopedic evaluation

NASA Technical Reports Server (NTRS)

Walden, T.

1978-01-01

The clinical performance of the Lixiscope in orthopedics was compared with routine radiography. Portability and size were the major advantages of the Lixiscope. The main disadvantage at this point in time was the Lixiscope's inability to study large areas.

A low-complexity 2-point step size gradient projection method with selective function evaluations for smoothed total variation based CBCT reconstructions.

PubMed

Song, Bongyong; Park, Justin C; Song, William Y

2014-11-07

The Barzilai-Borwein (BB) 2-point step size gradient method is receiving attention for accelerating Total Variation (TV) based CBCT reconstructions. In order to become truly viable for clinical applications, however, its convergence property needs to be properly addressed. We propose a novel fast converging gradient projection BB method that requires 'at most one function evaluation' in each iterative step. This Selective Function Evaluation method, referred to as GPBB-SFE in this paper, exhibits the desired convergence property when it is combined with a 'smoothed TV' or any other differentiable prior. This way, the proposed GPBB-SFE algorithm offers fast and guaranteed convergence to the desired 3DCBCT image with minimal computational complexity. We first applied this algorithm to a Shepp-Logan numerical phantom. We then applied to a CatPhan 600 physical phantom (The Phantom Laboratory, Salem, NY) and a clinically-treated head-and-neck patient, both acquired from the TrueBeam™ system (Varian Medical Systems, Palo Alto, CA). Furthermore, we accelerated the reconstruction by implementing the algorithm on NVIDIA GTX 480 GPU card. We first compared GPBB-SFE with three recently proposed BB-based CBCT reconstruction methods available in the literature using Shepp-Logan numerical phantom with 40 projections. It is found that GPBB-SFE shows either faster convergence speed/time or superior convergence property compared to existing BB-based algorithms. With the CatPhan 600 physical phantom, the GPBB-SFE algorithm requires only 3 function evaluations in 30 iterations and reconstructs the standard, 364-projection FDK reconstruction quality image using only 60 projections. We then applied the algorithm to a clinically-treated head-and-neck patient. It was observed that the GPBB-SFE algorithm requires only 18 function evaluations in 30 iterations. Compared with the FDK algorithm with 364 projections, the GPBB-SFE algorithm produces visibly equivalent quality CBCT image for the head-and-neck patient with only 180 projections, in 131.7 s, further supporting its clinical applicability.

p16/Ki-67 Dual Stain Cytology for Detection of Cervical Precancer in HPV-Positive Women.

PubMed

Wentzensen, Nicolas; Fetterman, Barbara; Castle, Philip E; Schiffman, Mark; Wood, Shannon N; Stiemerling, Eric; Tokugawa, Diane; Bodelon, Clara; Poitras, Nancy; Lorey, Thomas; Kinney, Walter

2015-12-01

Human papillomavirus (HPV)-based cervical cancer screening requires triage markers to decide who should be referred to colposcopy. p16/Ki-67 dual stain cytology has been proposed as a biomarker for cervical precancers. We evaluated the dual stain in a large population of HPV-positive women. One thousand five hundred and nine HPV-positive women screened with HPV/cytology cotesting at Kaiser Permanente California were enrolled into a prospective observational study in 2012. Dual stain cytology was performed on residual Surepath material, and slides were evaluated for dual stain-positive cells. Disease endpoints were ascertained from the clinical database at KPNC. We evaluated the clinical performance of the assay among all HPV-positive women and among HPV-positive, cytology-negative women. We used internal benchmarks for clinical management to evaluate the clinical relevance of the dual stain assay. We evaluated sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the dual stain compared with Pap cytology. All statistical tests were two-sided. The dual stain had lower positivity (45.9%) compared with cytology at an ASC-US threshold (53.4%). For detection of CIN2+, the dual stain had similar sensitivity (83.4% vs 76.6%, P = .1), and statistically higher specificity (58.9% vs 49.6%, P < .001), PPV (21.0% vs 16.6%, P < .001), and NPV (96.4% vs 94.2%, P = .01) compared with cytology. Similar patterns were observed for CIN3+. Women with a positive test had high enough risk for referral to colposcopy, while the risk for women with negative tests was below a one-year return threshold based on current US management guidelines. Dual stain cytology showed good risk stratification for all HPV-positive women and for HPV-positive women with normal cytology. Additional follow-up is needed to determine how long dual stain negative women remain at low risk of precancer. Published by Oxford University Press 2015. This work is written by (a) US Government employee(s) and is in the public domain in the US.

A test of the validity of the motivational interviewing treatment integrity code.

PubMed

Forsberg, Lars; Berman, Anne H; Kallmén, Håkan; Hermansson, Ulric; Helgason, Asgeir R

2008-01-01

To evaluate the Swedish version of the Motivational Interviewing Treatment Code (MITI), MITI coding was applied to tape-recorded counseling sessions. Construct validity was assessed using factor analysis on 120 MITI-coded sessions. Discriminant validity was assessed by comparing MITI coding of motivational interviewing (MI) sessions with information- and advice-giving sessions as well as by comparing MI-trained practitioners with untrained practitioners. A principal-axis factoring analysis yielded some evidence for MITI construct validity. MITI differentiated between practitioners with different levels of MI training as well as between MI practitioners and advice-giving counselors, thus supporting discriminant validity. MITI may be used as a training tool together with supervision to confirm and enhance MI practice in clinical settings. MITI can also serve as a tool for evaluating MI integrity in clinical research.

Susceptibility of functional impairment scales to noncredible responses in the clinical evaluation of adult ADHD.

PubMed

Fuermaier, Anselm B M; Tucha, Oliver; Koerts, Janneke; Butzbach, Marah; Weisbrod, Matthias; Aschenbrenner, Steffen; Tucha, Lara

2018-05-01

A growing body of research questions the reliance of symptom self-reports in the clinical evaluation of attention-deficit/hyperactivity disorder (ADHD) in adulthood. A recent study suggested that also impairment reports are vulnerable to noncredible responses, as derived from a simulation design using a global functional impairment scale. The present study aims to add evidence to this issue, by using an ADHD specific impairment scale in a simulation design on large samples. Impairment ratings on the Weiss Functional Impairment Rating Scale (WFIRS) of 62 patients with ADHD were compared to 142 healthy individuals who were instructed to show normal behavior. Furthermore, impairment ratings of patients with ADHD were compared to ratings of 330 healthy individuals who were randomly assigned to one of four simulation conditions that were instructed to complete the scale as if they had ADHD. Patients with ADHD reported higher levels of impairment than the healthy control group in all domains of life. Furthermore, individuals instructed to feign ADHD indicated higher levels of impairments in most domains of life compared to control participants and genuine patients with ADHD. The group differences between individuals feigning ADHD and individuals with genuine ADHD, however, were only small to moderate. Further analyses revealed that the WFRIS was not useful to successfully differentiate genuine from feigned ADHD. The present study confirms the conclusion that self-reported impairments are susceptible to noncredible responses and should be used with caution in the clinical evaluation of adult ADHD.

Clinical and Radiographic Evaluation of Procedural Errors during Preparation of Curved Root Canals with Hand and Rotary Instruments: A Randomized Clinical Study.

PubMed

Khanna, Rajesh; Handa, Aashish; Virk, Rupam Kaur; Ghai, Deepika; Handa, Rajni Sharma; Goel, Asim

2017-01-01

The process of cleaning and shaping the canal is not an easy goal to obtain, as canal curvature played a significant role during the instrumentation of the curved canals. The present in vivo study was conducted to evaluate procedural errors during the preparation of curved root canals using hand Nitiflex and rotary K3XF instruments. Procedural errors such as ledge formation, instrument separation, and perforation (apical, furcal, strip) were determined in sixty patients, divided into two groups. In Group I, thirty teeth in thirty patients were prepared using hand Nitiflex system, and in Group II, thirty teeth in thirty patients were prepared using K3XF rotary system. The evaluation was done clinically as well as radiographically. The results recorded from both groups were compiled and put to statistical analysis. Chi-square test was used to compare the procedural errors (instrument separation, ledge formation, and perforation). In the present study, both hand Nitiflex and rotary K3XF showed ledge formation and instrument separation. Although ledge formation and instrument separation by rotary K3XF file system was less as compared to hand Nitiflex. No perforation was seen in both the instrument groups. Canal curvature played a significant role during the instrumentation of the curved canals. Procedural errors such as ledge formation and instrument separation by rotary K3XF file system were less as compared to hand Nitiflex.

Performance of the digene LQ, RH and PS HPVs genotyping systems on clinical samples and comparison with HC2 and PCR-based Linear Array.

PubMed

Godínez, Jose M; Tous, Sara; Baixeras, Nuria; Moreno-Crespi, Judith; Alejo, María; Lejeune, Marylène; Bravo, Ignacio G; Bosch, F Xavier; de Sanjosé, Silvia

2011-11-18

Certain Human Papillomaviruses (HPVs) are the infectious agents involved in cervical cancer development. Detection of HPVs DNA is part of the cervical cancer screening protocols and HPVs genotyping has been proposed for its inclusion in these preventive programs. The aim of this study was to evaluate three novel genotyping tests, namely Qiagen LQ, RH and PS, in clinical samples with and without abnormalities. For this, 305 cervical samples were processed and the results of the evaluated techniques were compared with those obtained in the HPVs diagnostic process in our lab, by using HC2 and Linear Array (LA) technologies. The concordances and kappa statistics (k) for each technique compared with HC2 were 98.69% (k = 0.94) for LQ, 98.03% (k = 0.91) for RH and 91.80% (k = 0.82) for PS. There was a very good agreement in HPVs type-specific concordance for the most prevalent types HPV16 (kappa range = 0.83-0.90), HPV18 (k.r.= 0.74-0.80) and HPV45 (k.r.= 0.82-0.90). The three tests showed an overall good concordance for HPVs detection when compared with HR-HC2 system. LQ and RH rendered lower detection rate for multiple infections than LA genotyping. However, our understanding of the clinical significance of multiple HPVs infections is still incomplete and therefore the relevance of the lower ability to detect multiple infections needs to be evaluated.

Clinical and Radiographic Evaluation of Procedural Errors during Preparation of Curved Root Canals with Hand and Rotary Instruments: A Randomized Clinical Study

PubMed Central

Khanna, Rajesh; Handa, Aashish; Virk, Rupam Kaur; Ghai, Deepika; Handa, Rajni Sharma; Goel, Asim

2017-01-01

Background: The process of cleaning and shaping the canal is not an easy goal to obtain, as canal curvature played a significant role during the instrumentation of the curved canals. Aim: The present in vivo study was conducted to evaluate procedural errors during the preparation of curved root canals using hand Nitiflex and rotary K3XF instruments. Materials and Methods: Procedural errors such as ledge formation, instrument separation, and perforation (apical, furcal, strip) were determined in sixty patients, divided into two groups. In Group I, thirty teeth in thirty patients were prepared using hand Nitiflex system, and in Group II, thirty teeth in thirty patients were prepared using K3XF rotary system. The evaluation was done clinically as well as radiographically. The results recorded from both groups were compiled and put to statistical analysis. Statistical Analysis: Chi-square test was used to compare the procedural errors (instrument separation, ledge formation, and perforation). Results: In the present study, both hand Nitiflex and rotary K3XF showed ledge formation and instrument separation. Although ledge formation and instrument separation by rotary K3XF file system was less as compared to hand Nitiflex. No perforation was seen in both the instrument groups. Conclusion: Canal curvature played a significant role during the instrumentation of the curved canals. Procedural errors such as ledge formation and instrument separation by rotary K3XF file system were less as compared to hand Nitiflex. PMID:29042727

Evaluation of Three MALDI-TOF Mass Spectrometry Libraries for the Identification of Filamentous Fungi in Three Clinical Microbiology Laboratories in Manitoba, Canada.

PubMed

Stein, Markus; Tran, Vanessa; Nichol, Kimberly A; Lagacé-Wiens, Philippe; Pieroni, Peter; Adam, Heather J; Turenne, Christine; Walkty, Andrew J; Normand, Anne-Cécile; Hendrickx, Marijke; Piarroux, Renaud; Karlowsky, James A

2018-06-12

Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) is commonly used by clinical microbiology laboratories to identify bacterial pathogens and yeasts, but not for the identification of moulds. Recent progress in extraction protocols and the composition of comparative libraries support potential application of MALDI-TOF MS for mould identification in clinical microbiology laboratories. We evaluated the performance of the Bruker Microflex ™ MALDI-TOF MS instrument (Billerica, MA, USA) to identify clinical isolates and reference strains of moulds using three libraries, the Bruker mould library, the National Institutes of Health (NIH) library, and the Mass Spectrometry Identification (MSI) online library, and compared those results to conventional (morphological) and molecular (18S/ITS; gold standard) identification methods. All three libraries demonstrated greater accuracy in genus identification (≥94.9%) than conventional methods (86.4%). MALDI-TOF MS identified 73.3% of isolates to species-level compared to only 31.7% by conventional methods. The MSI library demonstrated the highest rate of species-level identification (72.0%) compared to NIH (19.5%) and Bruker (13.6%) libraries. Greater than 20% of moulds remained unidentified to species-level by all three MALDI-TOF MS libraries primarily because of library limitations or imperfect spectra. The overall identification rate of each MALDI-TOF MS library depended on the number of species and the number of spectra representing each species in the library. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

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

Active involvement and intervention in patients exposed to whiplash trauma in automobile crashes reduces costs: a randomized, controlled clinical trial and health economic evaluation.

PubMed

Rosenfeld, Mark; Seferiadis, Aris; Gunnarsson, Ronny

2006-07-15

To examine and compare the costs and consequences in a partial economic evaluation of two competing interventions in patients exposed to whiplash trauma in automobile crashes. The interventions were an active involvement and intervention using early mobilization and a standard intervention of rest, recommended short-term immobilization in a cervical collar and a cautious, gradual self-exercise program according to a leaflet. The study was randomized and controlled. The aim of the study was to compare the costs of an active involvement and intervention versus a standard intervention and to relate them to the clinical benefits in patients exposed to whiplash trauma in automobile crashes to facilitate decision-making regarding intervention and resource allocation. There is very little known about the health economic aspects of various interventions in the target treatment group of patients. Based on a prospective, randomized, clinical trial, data on clinical effectiveness and resources used for the active involvement and intervention and standard intervention were collected for a comparative analysis of the costs related to physical therapy treatment and sick leave. A cost-consequence analysis consisting of a modified cost-effectiveness analysis was used. The costs were significantly lower after 6 and 36 months with an active involvement and intervention as compared with the standard intervention. The active involvement and intervention were significantly superior in reducing experienced pain and reducing sick leave. For patients exposed to whiplash trauma in a motor vehicle collision, an active involvement and intervention were both less costly and more effective than a standard intervention.

Biological effect on restenosis and vascular healing of encapsulated paclitaxel nanocrystals delivered via coated balloon technology in the familial hypercholesterolaemic swine model of in-stent restenosis.

PubMed

Cheng, Yanping; Shibuya, Masahiko; McGregor, Jenn; Conditt, Gerard B; Yi, Geng-Hua; Kaluza, Greg L; Gray, William; Doshi, Manish; Sojitra, Prakash; Granada, Juan F

2016-10-20

The aim of this study was to evaluate the biological efficacy of a novel lower-dose (2.5 µg/mm2) encapsulated paclitaxel nanocrystal-coated balloon (Nano-PCB) in the familial hypercholesterolaemic swine (FHS) model of iliofemoral in-stent restenosis. Nano-PCB pharmacokinetics were assessed in 20 femoral arteries (domestic swine). Biological efficacy was evaluated in ten FHS: 14 days following bare metal stent implantation each stent segment was randomised to a clinically available PCB (IN.PACT, n=14), the Nano-PCB (n=14) or an uncoated balloon (n=12). Angiographic, optical coherence tomography and histological evaluation was performed at 28 days after treatment. Arterial paclitaxel concentration was 120.7 ng/mg at one hour and 7.65 ng/mg of tissue at 28 days with the Nano-PCB. Compared to the control uncoated group, both PCBs significantly reduced percent area stenosis (Nano-PCB: 36.0±14.2%, IN.PACT: 29.3±9.2% vs control: 67.9±15.1%, p<0.001). Neointimal distribution in the entire stent length was more homogenous in the Nano-PCB. Histological evaluation showed comparable degrees of neointimal proliferation in both PCBs; however, the Nano-PCB showed slightly higher levels of neointimal maturity and endothelialisation. Lower-dose encapsulated paclitaxel nanocrystals delivered via a coated balloon displayed comparable biological efficacy with superior healing features compared to a clinically validated PCB technology.

Routine identification of medical fungi by the new Vitek MS matrix-assisted laser desorption ionization-time of flight system with a new time-effective strategy.

PubMed

Iriart, Xavier; Lavergne, Rose-Anne; Fillaux, Judith; Valentin, Alexis; Magnaval, Jean-François; Berry, Antoine; Cassaing, Sophie

2012-06-01

We report here a clinical evaluation of the Vitek MS system for rapid fungal identification. A strategy that uses a single deposit without prior protein extraction was utilized to save time and money. Clinical isolates from the Toulouse University hospital were used to evaluate the performance of the Vitek MS compared to that of both routine laboratory techniques and Vitek2. The Vitek MS performed well in the identification of yeasts and Aspergillus fungi (93.2% of correct identifications).

Clinical evaluation of a helicase-dependant amplification (HDA)-based commercial assay for the simultaneous detection of HSV-1 and HSV-2.

PubMed

Teo, Jeanette W P; Chiang, Donald; Jureen, Roland; Lin, Raymond T P

2015-11-01

In this study, we evaluate the performance of a commercial assay, the AmpliVue HSV 1+2 Assay (Quidel), which employs HDA for the detection of both HSV-1 and HSV-2. The assay was tested on 307 clinical specimens (genital, oral, and dermal). When compared to shell vial virus culture and immunofluorescence typing of HSV, the positive percent agreement and negative percent agreement values were 98.2% and 90.9%, respectively. Excellent assay performance was demonstrated. Copyright © 2015 Elsevier Inc. All rights reserved.

Clinical evaluation of purified Shilajit on testosterone levels in healthy volunteers.

PubMed

Pandit, S; Biswas, S; Jana, U; De, R K; Mukhopadhyay, S C; Biswas, T K

2016-06-01

Purified Shilajit, an Ayurvedic rasayana, was evaluated in healthy volunteers of age between 45 and 55 years for its effect on male androgenic hormone viz. testosterone in a randomised, double-blind, placebo-controlled clinical study at a dose of 250 mg twice a day. Treatment with Shilajit for consecutive 90 days revealed that it has significantly (P < 0.05) increased total testosterone, free testosterone and dehydroepiandrosterone (DHEAS) compared with placebo. Gonadotropic hormones (LH and FSH) levels were well maintained. © 2015 The Authors. Andrologia Published by Blackwell Verlag GmbH.

Creation of an Internal Teledermatology Store-and-Forward System in an Existing Electronic Health Record

PubMed Central

Carter, Zachary A.; Goldman, Shauna; Anderson, Kristen; Li, Xiaxiao; Hynan, Linda S.; Chong, Benjamin F.

2017-01-01

Importance External store-and-forward (SAF) teledermatology systems operate separately from the primary health record and have many limitations, including care fragmentation, inadequate communication among clinicians, and privacy and security concerns, among others. Development of internal SAF workflows within existing electronic health records (EHRs) should be the standard for large health care organizations for delivering high-quality dermatologic care, improving access, and capturing other telemedicine benchmark data. Epic EHR software (Epic Systems Corporation) is currently one of the most widely used EHR system in the United States, and development of a successful SAF workflow within it is needed. Objectives To develop an SAF teledermatology workflow within the Epic system, the existing EHR system of Parkland Health and Hospital System (Dallas, Texas), assess its effectiveness in improving access to care, and validate its reliability; and to evaluate the system’s ability to capture meaningful outcomes. Design, Setting, and Participants Electronic consults were independently evaluated by 2 board-certified dermatologists, who provided diagnoses and treatment plans to primary care physicians (PCPs). Results were compared with in-person referrals from May to December 2013 from the same clinic (a community outpatient clinic in a safety-net public hospital system). Patients were those 18 years or older with dermatologic complaints who would have otherwise been referred to dermatology clinic. Main Outcomes and Measures Median time to evaluation; percentage of patients evaluated by a dermatologist through either teledermatology or in-person compared with the previous year. Results Seventy-nine teledermatology consults were placed by 6 PCPs from an outpatient clinic between May and December 2014; 57 (74%) were female and their mean (SD) age was 47.0 (12.4) years. Teledermatology reduced median time to evaluation from 70.0 days (interquartile range [IQR], 33.25-83.0 days) to 0.5 days (IQR, 0.172-0.94 days) and median time to treatment from 73.5 to 3.0 days compared with in-person dermatology visits. Overall, a greater percentage of patients (120 of 144 [83.3%]) were evaluated by a dermatologist through either teledermatology or in-person during the 2014 study period compared with the previous year (111 of 173 [64.2%]). Primary care physicians followed management recommendations 93% of the time. Conclusions and Relevance Epic-based SAF teledermatology can improve access to dermatologic care in a public safety-net hospital setting. We hope that the system will serve as a model for other health care organizations wanting to create SAF teledermatology workflows within the Epic EHR system. PMID:28423156

Comparison of autogeneic and allogeneic natural killer cells immunotherapy on the clinical outcome of recurrent breast cancer

PubMed Central

Liang, Shuzhen; Xu, Kecheng; Niu, Lizhi; Wang, Xiaohua; Liang, Yingqing; Zhang, Mingjie; Chen, Jibing; Lin, Mao

2017-01-01

In the present study, we aimed to compare the clinical outcome of autogeneic and allogeneic natural killer (NK) cells immunotherapy for the treatment of recurrent breast cancer. Between July 2016 and February 2017, 36 patients who met the enrollment criteria were randomly assigned to two groups: autogeneic NK cells immunotherapy group (group I, n=18) and allogeneic NK cells immunotherapy group (group II, n=18). The clinical efficacy, quality of life, immune function, circulating tumor cell (CTC) level, and other related indicators were evaluated. We found that allogeneic NK cells immunotherapy has better clinical efficacy than autogeneic therapy. Moreover, allogeneic NK cells therapy improves the quality of life, reduces the number of CTCs, reduces carcinoembryonic antigen and cancer antigen 15-3 (CA15-3) expression, and significantly enhances immune function. To our knowledge, this is the first clinical trial to compare the clinical outcome of autogeneic and allogeneic NK cells immunotherapy for recurrent breast cancer. PMID:28894383

Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

PubMed

Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

2018-06-01

There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

Expense comparison of a telemedicine practice versus a traditional clinical practice.

PubMed

Barker, Gail P; Krupinski, Elizabeth A; Schellenberg, Bonnie; Weinstein, Ronald S

2004-01-01

This paper compares the expenses of a telemedicine program to those of a traditional clinical practice using data from two fiscal years (FY) 1998/1999 and 2000/2001. As part of that evaluation, we compared expenses of the University of Arizona's clinical practice group, the University Physicians Incorporated (UPI), to those of the Arizona Telemedicine Program (ATP) practice. For this study, we used the reporting categories published in the year-end UPI financial statement. These categories included clinical services, administration, equipment depreciation, and overhead. Results showed that clinical service expenses and administrative expenses for FY 2000/2001 were higher in the traditional UPI practice, whereas equipment depreciation and overhead expenses are higher in the telemedicine practice. This differs somewhat from FY 1998/1999, where clinical expenses and overhead were higher in the UPI practice and administration and equipment depreciation were higher in the telemedicine practice. We will discuss the relevance of these results and the critical factors that contribute to these differences.

Evaluation of the efficacy and safety of a CS20® protective barrier gel containing OGT compared with topical aciclovir and placebo on functional and objective symptoms of labial herpes recurrences: a randomized clinical trial.

PubMed

Khemis, A; Duteil, L; Coudert, A C; Tillet, Y; Dereure, O; Ortonne, J P

2012-10-01

Topical or systemic antiviral drugs reduce the duration of herpes simplex virus 1 (HSV-1) recurrences but may not alleviate functional symptoms. To assess the efficacy and safety of CS20 (Acura 24(®) ) protective barrier gel versus topical aciclovir and placebo in resolving functional symptoms in HSV-1 labial recurrences. A prospective, randomized, single-centre, assessor-blinded study of CS20 versus topical aciclovir or placebo. The primary endpoint was the total score of four herpes-related functional symptoms (pain, burning, itching, and tingling sensations), evaluated by visual analogue scale (VAS). Secondary endpoints encompassed objective skin changes (oedema, crusting and erythema), evaluated by specific clinical scores. In a study of 106 patients, compared with placebo, a significant improvement in total functional symptom score was observed after 1 day of treatment in the CS20 group, but only after 7 days of treatment in the topical aciclovir group. Burning sensations were significantly reduced by CS20 compared with aciclovir (Days 1-2) or placebo (Days 1-7). Compared to placebo, CS20 significantly reduced pain intensity on Days 1-6. CS20 induced significant and early improvements in the clinical scores for oedema and crusting compared with placebo. Time to cure was similar for CS20 and aciclovir. The treatments were well tolerated and adverse events were comparable in the three treatment groups. Limitations  The single-centre and single-blind design of the study and the preselection of patients. CS20 showed superior effectiveness against functional symptoms (pain and burning) associated with HSV-1 labial recurrences and was similar to aciclovir for time to cure. © 2011 The Authors. Journal of the European Academy of Dermatology and Venereology © 2011 European Academy of Dermatology and Venereology.

Evaluation of a Multicolor, Single-Tube Technique To Enumerate Lymphocyte Subpopulations▿

PubMed Central

Colombo, F.; Cattaneo, A.; Lopa, R.; Portararo, P.; Rebulla, P.; Porretti, L.

2008-01-01

To evaluate the fully automated FACSCanto software, we compared lymphocyte subpopulation counts obtained using three-color FACSCalibur-CELLQuest and six-color FACSCanto-FACSCanto software techniques. High correlations were observed between data obtained with these techniques. Our study indicated that FACSCanto clinical software is accurate and sensitive in single-platform lymphocyte immunophenotyping. PMID:18448621

Assessment of Diverse Biological Indicators in Gulf War Illness: Are They Replicable Are They Related

DTIC Science & Technology

2016-04-01

compared to 50 healthy veteran controls in a protocol that includes physical and neuropsychological evaluations, neuroimaging (MRI, fMRI, DTI), adrenal...SUBJECT TERMS Gulf War illness, neuroimaging, neuropsychological testing, immune function, hypothalamic-pituitary-adrenal testing 16. SECURITY... neuropsychological evaluations, assessment of hypothalamic-pituitary-adrenal function, standard clinical diagnostic laboratory tests, and research

Levonorgestrel-Releasing Intrauterine System for Women With Polycystic Ovary Syndrome: Metabolic and Clinical Effects.

PubMed

da Silva, Adriana Valerio; de Melo, Anderson Sanches; Barboza, Rebecca Pontelo; de Paula Martins, Wellington; Ferriani, Rui Alberto; Vieira, Carolina Sales

2016-07-01

Polycystic ovary syndrome (PCOS) is related to clinical and metabolic comorbidities that may limit the prescription of combined hormonal contraceptives, with consequent need to use progestogen-only contraceptives (POCs). Thus, the objective of the present study was to evaluate the clinical and metabolic effects of a POC, the levonorgestrel-releasing intrauterine system (LNG-IUS), in women with PCOS followed up over a period of 6 months compared to baseline and to women without PCOS. Thus, an observational, prospective, controlled study was conducted on 30 women with a diagnosis of PCOS who presented adverse effect secondary to the use of combined oral contraceptives (nausea, headache, mastalgia or vomiting; PCOS group) paired with 30 ovulatory women without PCOS (control group), both groups being free of comorbidities and having chosen the LNG-IUS as contraceptive. Clinical, laboratory, and ultrasonographic variables were evaluated immediately before LNG-IUS insertion and 6 months after the use of this method. Before LNG-IUS insertion, the PCOS group had higher total testosterone levels (P = .04), lower HDL levels (P = .04), and greater ovarian volume (P < .01) than the control group. Six months after LNG-IUS insertion, there was a 2.3% increase in abdominal circumference (P = .04) and a 3.4% increase in fasting glycemia (P = .02). On the other hand, mean ovarian volume was 10% smaller compared to the volume found before LNG-IUS insertion (P = .04), LDL levels were reduced by 5.2% (P = .03), and total cholesterol levels were reduced by 6.7% (P < .01) compared to baseline evaluation in the PCOS group. The remaining variables did not differ significantly during the 6 months of observation. The control group did not show significant changes compared to the period before LNG-IUS insertion. When the groups were compared after the 6-month follow-up, only glycemia showed a statistically significant variation between the groups, with glycemia levels increasing by 3.4% in the PCOS group and decreasing by 2.6% in the control group (P = .008). In conclusion, the use of the LNG-IUS for 6 months was not associated with relevant changes in clinical or metabolic variables of women with no comorbidities regardless of the presence of PCOS. © The Author(s) 2016.

An early evaluation of clinical and economic costs and benefits of implementing point of care NAAT tests for Chlamydia trachomatis and Neisseria gonorrhoea in genitourinary medicine clinics in England.

PubMed

Turner, Katherine M E; Round, Jeff; Horner, Patrick; Macleod, John; Goldenberg, Simon; Deol, Arminder; Adams, Elisabeth J

2014-03-01

To estimate the costs and benefits of clinical pathways incorporating a point of care (POC) nucleic acid amplification test (NAAT) for chlamydia and gonorrhoea in genitourinary medicine (GUM) clinics compared with standard off-site laboratory testing. We simulated 1.2 million GUM clinic attendees in England. A simulation in Microsoft Excel was developed to compare existing standard pathways of management for chlamydia and gonorrhoea with a POC NAAT. We conducted scenario analyses to evaluate the robustness of the model findings. The primary outcome was the incremental cost-effectiveness ratio. Secondary outcomes included the number of inappropriate treatments, complications and transmissions averted. The baseline cost of using the point of POC NAAT was £103.9 million compared with £115.6 million for standard care. The POC NAAT was also associated with a small increase of 46 quality adjusted life years, making the new test both more effective and cheaper. Over 95 000 inappropriate treatments might be avoided by using a POC NAAT. Patients receive diagnosis and treatment on the same day as testing, which may also prevent 189 cases of pelvic inflammatory disease and 17 561 onward transmissions annually. Replacing standard laboratory tests for chlamydia and gonorrhoea with a POC test could be cost saving and patients would benefit from more accurate diagnosis and less unnecessary treatment. Overtreatment currently accounts for about a tenth of the reported treatments for chlamydia and gonorrhoea and POC NAATs would effectively eliminate the need for presumptive treatment.

A retrospective clinical study of cervical restorations: longevity and failure-prognostic variables.

PubMed

Namgung, C; Rho, Y J; Jin, B H; Lim, B S; Cho, B H

2013-01-01

The aim of this retrospective clinical study was to compare the longevity of cervical restorations between resin composite (RC) and glass ionomer (GI) and to investigate variables predictive of their outcome. The clinical performance of the two restorative materials in function was compared using the ratings of the modified United States Public Health Service (USPHS) criteria. A total of 479 cervical restorations were included in the study. Ninety-one already-replaced restorations were reviewed from dental records. The other 388 restorations still in function were evaluated according to the modified USPHS criteria by two investigators. Longevity and prognostic variables were analyzed with the Kaplan-Meier survival analysis and multivariate Cox proportional hazard model. The clinical performances of the two materials were evaluated according to the ratings of the USPHS criteria and compared using the Pearson chi-square test and Fisher exact test. The longevity was not significantly different between RC and GI (median survival time, 10.4 ± 0.7 and 11.5 ± 1.1 years, respectively). The main reasons for failure were loss of retention (82.2%) and secondary caries (17.8%). The longevity of cervical restoration was significantly influenced by tooth group and operator group (Wald test, p<0.05), while material, gender, presence or absence of systemic diseases, arch, and reason for treatment did not affect the longevity. Contrary to the longevity, the clinical performance of RC was superior to GI in the criteria of retention, marginal discoloration, and marginal adaptation, but similar in secondary caries, wear, and postoperative sensitivity.

Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study.

PubMed

Halstead, Jill; Chapman, Graham J; Gray, Janine C; Grainger, Andrew J; Brown, Sarah; Wilkins, Richard A; Roddy, Edward; Helliwell, Philip S; Keenan, Anne-Maree; Redmond, Anthony C

2016-04-01

This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.

Comparative evaluation of border molding using two different techniques in maxillary edentulous arches: A clinical study

PubMed Central

Qanungo, Anchal; Aras, Meena Ajay; Chitre, Vidya; Coutinho, Ivy; Rajagopal, Praveen; Mysore, Ashwin

2016-01-01

Purpose: The aim of this in vivo study was to compare the single-step border molding technique using injectable heavy viscosity addition silicone with sectional border molding technique using low fusing impression compound by evaluating the retention of heat cure trial denture bases. Materials and Methods: Ten completely edentulous patients in need of prostheses were included in this study. Two border molding techniques, single-step (Group 1) and sectional (Group 2), were compared for retention. Both border molding techniques were performed in each patient. In both techniques, definitive wash impression was made with light viscosity addition silicone. The final results were analyzed using paired t-test to determine whether significant differences existed between the groups. Results: The t-value (3.031) infers that there was a significant difference between Group 1 and Group 2 (P = 0.014). The retention obtained in Group 2 (mean = 9.05 kgf) was significantly higher than that of Group 1 (mean = 8.26 kgf). Conclusion: Sectional border molding technique proved to be more retentive as compared to single-step border molding although clinically the retention appeared comparable. PMID:27746597

Scaling-Up Access to Antiretroviral Therapy for Children: A Cohort Study Evaluating Care and Treatment at Mobile and Hospital-Affiliated HIV Clinics in Rural Zambia

PubMed Central

van Dijk, Janneke H.; Moss, William J.; Hamangaba, Francis; Munsanje, Bornface; Sutcliffe, Catherine G.

2014-01-01

Background Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia. Methods Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility. Results Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ) and CD4+ T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4+ T-cell percentages. Conclusions HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas. PMID:25122213

Current role of cryotherapy in retinopathy of prematurity: a report by the American Academy of Ophthalmology.

PubMed

Simpson, Jennifer L; Melia, Michele; Yang, Michael B; Buffenn, Angela N; Chiang, Michael F; Lambert, Scott R

2012-04-01

To evaluate the role of cryotherapy in the current treatment of retinopathy of prematurity (ROP). Literature searches of PubMed and the Cochrane Library were conducted on December 2, 2009, for articles published after 1984. The searches included all languages and retrieved 187 relevant citations. Thirteen articles were deemed relevant to the assessment question and were rated according to the strength of evidence. Four articles reported results from 2 large multicenter randomized clinical trials, and the remaining 9 articles reported results of 3 small randomized trials that directly compared cryotherapy and laser. Neither of the multicenter randomized clinical trials was a direct comparison of cryotherapy with laser. These studies were used to evaluate the comparative trials based on treatment criteria, study populations, and clinical results. Higher percentages of poor structural and functional outcomes generally were seen in eyes treated with cryotherapy compared with eyes undergoing laser treatment. Higher rates of systemic complications and myopia also were identified after treatment with cryotherapy. Despite a relative paucity of level I evidence directly comparing cryotherapy and laser treatment for threshold ROP, the literature suggests that neonatal facilities should gain access to laser technology and laser-trained ophthalmic staff to achieve better outcomes for treatment of the disease. Copyright © 2012 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

[Comparative evaluation of clinical and economic efficiency of paliperidone in various dosage forms used in patients with schizophrenia].

PubMed

D'yakov, I N; Zyryanov, S K

To evaluate clinical and economic efficacy of schizophrenia treatment with three forms of paliperidone (peroral form, intramuscular injections once a month and once in three month). Pharmacoeconomic analysis based on the results of earlier foreign randomized clinical studies on paliperidone in treatment of schizophrenia was carried out. Indirect comparison of different medication forms of paliperidone compared to placebo was performed. The analysis of costs was based on a Markov model built for the study. Two categories of costs: costs of pharmacological treatment with paliperidone and costs of disease exacerbation due to the violation of treatment regimen were considered. To assess pharmacoeconomic efficacy of paliperidone, a cost-benefit analysis with calculation of cost utility ratio (CUR) and incremental cost utility ratio (ICUR) was used. In view of the influence on the budget, all forms of paliperidone have similar pharmacoeconomic efficacy with the advantage of prolonged release injectable (depot) forms that increase patient's adherence to treatment. As a result, CUR of injectable forms was lower compared to that of the peroral form by 11,1 and 46,3% of month and 3-month forms, respectively. ICUR for paliperidone used once in 3 month (trevicta) was more effective compared to paliperidone used monthly (xeplion). It has been concluded that paliperidone for prolonged release injections used once in 3 month is most pharmacoeconomically effective.

Sepsis biomarkers in neutropaenic systemic inflammatory response syndrome patients on standard care wards.

PubMed

Ratzinger, Franz; Haslacher, Helmuth; Perkmann, Thomas; Schmetterer, Klaus G; Poeppl, Wolfgang; Mitteregger, Dieter; Dorffner, Georg; Burgmann, Heinz

2015-08-01

Neutropaenic patients are at a high risk of contracting severe infections. In particular, in these patients, parameters with a high negative predictive value are desirable for excluding infection or bacteraemia. This study evaluated sepsis biomarkers in neutropaenic patients suffering from systemic inflammatory response syndrome (SIRS). Further, the predictive capacities of evaluated biomarkers in neutropaenic SIRS patients were compared to non-neutropaenic SIRS patients. In this prospective observational cohort study, patients with clinically suspected sepsis were screened. The predictive capacities of procalcitonin (PCT), C-reactive protein and lipopolysaccharide-binding protein (LBP) in neutropaenic SIRS patients were evaluated in terms of their potential to identify infection or bacteraemia and were compared to results for non-neutropaenic SIRS patients. To select an appropriate control cohort, propensity score matching was applied, balancing confounding factors between neutropaenic and non-neutropaenic SIRS patients. Of 3370 prospectively screened patients with suspected infection, 51 patients suffered from neutropaenic SIRS. For the identification of infection, none of the assessed biomarkers presented a clinically relevant discriminatory potency. Lipopolysaccharide-binding protein and PCT demonstrated discriminatory capacity to discriminate between nonbacteraemic and bacteraemic SIRS in patients with neutropaenia [receiver-operating characteristics-area under the curves (ROC-AUCs): 0.860, 0.818]. In neutropaenic SIRS patients, LBP had a significantly better ROC-AUC than in a comparable non-neutropaenic patient cohort for identifying bacteraemia (P = 0.01). In neutropaenic SIRS patients, none of the evaluated biomarkers was able to adequately identify infection. LBP and PCT presented a good performance in identifying bacteraemia. Therefore, these markers could be used for screening purposes to increase the pretest probability of blood culture analysis. © 2015 Stichting European Society for Clinical Investigation Journal Foundation.

Economic Evaluation and Transferability of Physical Activity Programmes in Primary Prevention: A Systematic Review

PubMed Central

Wolfenstetter, Silke B.; Wenig, Christina M.

2010-01-01

This systematic review aims to assess the characteristics of, and the clinical and economic evidence provided by, economic evaluations of primary preventive physical exercise interventions, and to analyse their transferability to Germany using recommended checklists. Fifteen economic evaluations from seven different countries met eligibility criteria, with seven of the fifteen providing high economic evidence in the special country context. Most of the identified studies conclude that the investigated intervention provide good value for money compared with alternatives. However, this review shows a high variability of the costing methods between the studies, which limits comparability, generalisability and transferability of the results. PMID:20617050

Salicylic acid for the treatment of melasma: new acquisitions for monitoring the clinical improvement.

PubMed

Fabbrocini, Gabriella; De Vita, Valerio; Marasca, Claudio; Palmisano, Franco; Monfrecola, Giuseppe

2013-11-01

The Melasma Area and Severity Index (MASI) and the Melasma Severity Score (MSS) are calculated on the basis of only a subjective clinical assessment. This raises the need to have an objective score, uniform in the evaluation by different clinicians. The purpose of this study was to establish if the images by Canfield Reveal Imager can be correlated to MASI score to better evaluate the clinical efficacy of salicylic acid 33% peeling in the treatment of melasma respect to the clinical observation. The study was a voluntary observational study. Twenty female patients affected with melasma, aged between 30 and 60 years, were included in the study. Treatment with salicylic acid 33% was performed once a month, for a total of four times. The dermatologist (Doc A) examined each patient's melasma areas using MASI score, at the face-to-face observation and at Reveal images evaluation during the first (T0) and the end point time (T4). Digital photographs were also evaluated by another experienced dermatologist (Doc B), who has never seen clinically the patients before and who evaluated MASI score by Reveal images at time T0 and T4. Student's t-test and linear regression test were performed, showing statistically significant values comparing MASI score obtained by digital photo and MASI score obtained clinically. The monitoring of the improvement by Reveal images can optimize the treatment approach and the efficacy of same dermocosmetics procedures can be revised following standard criteria. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Performance evaluation of integrating detectors for near-infrared fluorescence molecular imaging

NASA Astrophysics Data System (ADS)

Zhu, Banghe; Rasmussen, John C.; Sevick-Muraca, Eva M.

2014-05-01

Although there has been a plethora of devices advanced for clinical translation, there has been no standards to compare and determine the optical device for fluorescence molecular imaging. In this work, we compare different CCD configurations using a solid phantom developed to mimic pM - fM concentrations of near-infrared fluorescent dyes in tissues. Our results show that intensified CCD systems (ICCDs) offer greater contrast at larger signal-tonoise ratios (SNRs) in comparison to their un-intensified CCD systems operated at clinically reasonable, sub-second acquisition times. Furthermore, we compared our investigational ICCD device to the commercial NOVADAQ SPY system, demonstrating different performance in both SNR and contrast.

Orthodontic treatment need among young Saudis attending public versus private dental practices in Riyadh

PubMed Central

Al-Jobair, Asma M; Baidas, Laila F; Al-Hamid, Anfal A; Al-Qahtani, Sara G; Al-Najjar, Amani T; Al-Kawari, Huda M

2016-01-01

Objective To assess and compare the severity of malocclusion and orthodontic treatment need among young Saudis receiving free treatment at public dental practices versus those paying for treatment at private practices. Materials and methods This retrospective study evaluated the records of 300 patients (179 females, 121 males; age 13–21 years) treated at orthodontic clinics from 2013 through 2015. The public sample was selected from orthodontic clinics at the College of Dentistry, King Saud University (KSU); the private sample was selected from five private orthodontic clinics in Riyadh, Saudi Arabia. The records were examined for the severity of malocclusion and for orthodontic treatment need using the Dental Health Component of the Index of Orthodontic Treatment Need. The prevalence of each occlusal discrepancy and the Dental Health Component grade were recorded. The severity of malocclusion and orthodontic treatment need were compared between practice types, age groups, and sexes with the chi-square test. Results Displacement, increased overjet, and Class II and III malocclusion were the most common orthodontic problems in this study. Patients attending public clinics at KSU generally had more severe malocclusion than the patients attending private clinics. Seventy-seven percent of orthodontically treated patients at KSU clinics were in great need of treatment, compared with 58.5% of patients treated at private clinics (P=0.003). Among the patients with great treatment need, approximately 62% of male patients and 70% of patients ≤16 years of age were treated at KSU clinics, compared with 38% and 48%, respectively, treated at private clinics (P<0.0001). Conclusion Young Saudis receiving free orthodontic treatment at public clinics at KSU had more severe malocclusion with greater need of orthodontic treatment than the patients paying for treatment at private clinics. PMID:27843351

Orthodontic treatment need among young Saudis attending public versus private dental practices in Riyadh.

PubMed

Al-Jobair, Asma M; Baidas, Laila F; Al-Hamid, Anfal A; Al-Qahtani, Sara G; Al-Najjar, Amani T; Al-Kawari, Huda M

2016-01-01

To assess and compare the severity of malocclusion and orthodontic treatment need among young Saudis receiving free treatment at public dental practices versus those paying for treatment at private practices. This retrospective study evaluated the records of 300 patients (179 females, 121 males; age 13-21 years) treated at orthodontic clinics from 2013 through 2015. The public sample was selected from orthodontic clinics at the College of Dentistry, King Saud University (KSU); the private sample was selected from five private orthodontic clinics in Riyadh, Saudi Arabia. The records were examined for the severity of malocclusion and for orthodontic treatment need using the Dental Health Component of the Index of Orthodontic Treatment Need. The prevalence of each occlusal discrepancy and the Dental Health Component grade were recorded. The severity of malocclusion and orthodontic treatment need were compared between practice types, age groups, and sexes with the chi-square test. Displacement, increased overjet, and Class II and III malocclusion were the most common orthodontic problems in this study. Patients attending public clinics at KSU generally had more severe malocclusion than the patients attending private clinics. Seventy-seven percent of orthodontically treated patients at KSU clinics were in great need of treatment, compared with 58.5% of patients treated at private clinics ( P =0.003). Among the patients with great treatment need, approximately 62% of male patients and 70% of patients ≤16 years of age were treated at KSU clinics, compared with 38% and 48%, respectively, treated at private clinics ( P <0.0001). Young Saudis receiving free orthodontic treatment at public clinics at KSU had more severe malocclusion with greater need of orthodontic treatment than the patients paying for treatment at private clinics.

Improving teaching on an inpatient pediatrics service: a retrospective analysis of a program change

PubMed Central

2012-01-01

Background The traditional role of the faculty inpatient attending providing clinical care and effectively teaching residents and medical students is threatened by increasing documentation requirements, pressures to increase clinical productivity, and insufficient funding available for medical education. In order to sustain and improve clinical education on a general pediatric inpatient service, we instituted a comprehensive program change. Our program consisted of creating detailed job descriptions, setting clear expectations, and providing salary support for faculty inpatient attending physicians serving in clinical and educational roles. This study was aimed at assessing the impact of this program change on the learners’ perceptions of their faculty attending physicians and learners’ experiences on the inpatient rotations. Methods We analyzed resident and medical student electronic evaluations of both clinical and teaching faculty attending physician characteristics, as well as resident evaluations of an inpatient rotation experience. We compared the proportions of “superior” ratings versus all other ratings prior to the educational intervention (2005–2006, baseline) with the two subsequent years post intervention (2006–2007, year 1; 2007–2008, year 2). We also compared medical student scores on a comprehensive National Board of Medical Examiners clinical subject examination pre and post intervention. Results When compared to the baseline year, pediatric residents were more likely to rate as superior the quality of didactic teaching (OR=1.7 [1.0-2.8] year 1; OR=2.0 [1.1-3.5] year 2) and attendings’ appeal as a role model (OR=1.9 [1.1-3.3] year 2). Residents were also more likely to rate as superior the quality of feedback and evaluation they received from the attending (OR=2.1 [1.2-3.7] year 1; OR=3.9 [2.2-7.1] year 2). Similar improvements were also noted in medical student evaluations of faculty attendings. Most notably, medical students were significantly more likely to rate feedback on their data gathering and physical examination skills as superior (OR=4.2 [2.0-8.6] year 1; OR=6.4 [3.0-13.6] year 2). Conclusions A comprehensive program which includes clear role descriptions along with faculty expectations, as well as salary support for faculty in clinical and educational roles, can improve resident and medical student experiences on a general pediatric inpatient service. The authors provide sufficient detail to replicate this program to other settings. PMID:23020896

[Effects of hypnosis in dental care].

PubMed

Jugé, Charlène; Tubert-Jeannin, Stéphanie

2013-04-01

Hypnosis is widely used in medicine and dentistry, but many practitioners still consider it as a mysterious technique. Thus, a systematic review was conducted to assess the effects of hypnosis during dental treatment. A literature search was conducted on PubMed (1981-2012) to retrieve references, written in French or English, reporting controlled clinical studies that have evaluated any type of hypnosis. The quality of included studies was assessed by evaluating randomisation, blindness and drop-outs. The effects of hypnosis on anxiety, physiological parameters, patients' behaviour or pain were analysed descriptively. The electronic search retrieved 556 references. Nine studies, generally characterized by low methodological quality, were selected. Results indicated that hypnosis has significant positive effects on anxiety, pain, behaviour and physiological parameters when it is compared with no treatment. When hypnosis is compared with other psychological treatment such as cognitive behavioral therapy (CBT), the effects on anxiety and behaviour are almost identical with an advantage for CBT. Individualized hypnosis brings more benefits than standardized hypnosis with audio recordings. This review demonstrated the effectiveness of hypnosis but the poor quality of the clinical studies and the multiplicity of evaluation outcomes limit the level of evidence. It is therefore necessary to conduct further clinical studies to confirm the effects of hypnosis during dental treatments. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Evaluation of safety and efficacy of 980-nm diode laser-assisted lipolysis versus traditional liposuction for submental rejuvenation: A randomized clinical trial.

PubMed

Valizadeh, Neda; Jalaly, Niloofar Y; Zarghampour, Manijeh; Barikbin, Behrooz; Haghighatkhah, Hamid Reza

2016-01-01

Submental fat accumulation and skin laxity is a frequent concern of cosmetic patients. The aim of this randomized prospective controlled clinical trial was to compare the efficacy and safety of laser-assisted lipolysis and liposuction in the submental rejuvenation. Thirty-six female adults were enrolled in this clinical trial and were categorized into two groups: group 1 underwent 980-nm diode laser with the power of 6-8 W and group 2 underwent traditional liposuction. Patients were evaluated with ultrasonography 2 weeks and 2 months after the procedures. Ultrasonographic evaluation reported the significant reduction of fat thickness in each group compared with the baseline (p value < 0.001). At the 2 weeks and 2 months follow-up visit, fat thickness reduction was significantly higher in the lipolysis group (p value < 0.05). Overall patients' satisfaction in lipolysis group was higher than liposuction with 11 (61%) of lipolysis patients being very satisfied in contrast to 10 (55.5%) of liposuction patients reporting "dissatisfied or neutral" results. Laser-assisted lipolysis using 980-nm diode is approved to be safe and effective for skin tightening and rejuvenation of the submental area and seems to be a better option than traditional techniques for treatment of this cosmetic problem.

Revisiting physical examination: Abadie's sign and Achilles intratendinous changes in subjects with diabetes.

PubMed

Abate, Michele; Schiavone, Cosima; Salini, Vincenzo; Andia, Isabel

2014-01-01

The aim of this study was to evaluate whether or not the positivity of Abadie's sign could be an indicator of asymptomatic Achilles intratendinous changes. A total of 18 patients (36 tendons) suffering from diabetes, with at least 1 Achilles tendon positive to Abadie's sign, were compared to matched subjects with diabetes bilaterally negative to Abadie's sign. Anthropometric measures and the Toronto Clinical Neuropathy Score were registered. Echotexture was evaluated and degenerative features classified as absent, mild, moderate and severe. The frequencies of structural abnormalities, according to both Abadie's sign and the Toronto Clinical Neuropathy Score, were determined. In the first group 26 out of 36 tendons (72.2%) showed positive Abadie's sign and a significantly higher frequency of moderate and severe (65.3%) structural abnormalities compared to Achilles tendons with negative sign (4.3%; p < 0.0001). This frequency was similar to that observed in the subjects with the highest Toronto Clinical Neuropathy Score (64.2%). This study showed that Abadie's sign was a useful tool for assisting in the diagnosis of asymptomatic Achilles intratendinous changes, which, when detected early, could help prevent unexpected tendon rupture. The concordance between Abadie's sign and Achilles sonographic abnormalities needs to be evaluated in a larger sample to consider it useful for practical purposes. © 2013 S. Karger AG, Basel.

Cognitive and noncognitive neurological features of young-onset dementia.

PubMed

Kelley, Brendan J; Boeve, Bradley F; Josephs, Keith A

2009-01-01

The rarity of young-onset dementia (YOD), the broad differential diagnosis and unusual clinical presentations present unique challenges to correctly recognize the condition and establish an accurate diagnosis. Limited data exist regarding clinical features associated with dementia prior to the age of 45. We retrospectively assessed cognitive and noncognitive neurological characteristics of 235 patients who presented for evaluation of YOD to investigate the clinical characteristics of YOD compared to later-onset dementias and to identify clinical features associated with specific etiologies that may aid in the evaluation of YOD. Multiple cognitive domains were affected in most patients, and no significant differences in affected domains existed between groups. Early psychiatric and behavioral features occurred at very high frequencies. Nearly 80% of this YOD cohort had additional noncognitive symptoms or signs as a feature of their disease. Chorea was strongly associated with Huntington disease. Parkinsonism was not seen in patients having an autoimmune/inflammatory etiology. The rarity of YOD and the high frequency of early psychiatric features led to frequent misdiagnosis early in the clinical course. The high frequency of noncognitive symptoms and signs may aid clinicians in distinguishing patients requiring a more extensive evaluation for YOD.

Interobserver reproducibility and accuracy of p16/Ki-67 dual-stain cytology in cervical cancer screening.

PubMed

Wentzensen, Nicolas; Fetterman, Barbara; Tokugawa, Diane; Schiffman, Mark; Castle, Philip E; Wood, Shannon N; Stiemerling, Eric; Poitras, Nancy; Lorey, Thomas; Kinney, Walter

2014-12-01

Dual-stain cytology for p16 and Ki-67 has been proposed as a biomarker in cervical cancer screening. The authors evaluated the reproducibility and accuracy of dual-stain cytology among 10 newly trained evaluators. In total, 480 p16/Ki-67-stained slides from human papillomavirus-positive women were evaluated in masked fashion by 10 evaluators. None of the evaluators had previous experience with p16 or p16/Ki-67 cytology. All participants underwent p16/Ki-67 training and subsequent proficiency testing. Reproducibility of dual-stain cytology was measured using the percentage agreement, individual and aggregate κ values, as well as McNemar statistics. Clinical performance for the detection of cervical intraepithelial neoplasia grade 2 or greater (CIN2+) was evaluated for each individual evaluator and for all evaluators combined compared with the reference evaluation by a cytotechnologist who had extensive experience with dual-stain cytology. The percentage agreement of individual evaluators with the reference evaluation ranged from 83% to 91%, and the κ values ranged from 0.65 to 0.81. The combined κ value was 0.71 for all evaluators and 0.73 for cytotechnologists. The average sensitivity and specificity for the detection of CIN2+ among novice evaluators was 82% and 64%, respectively; whereas the reference evaluation had 84% sensitivity and 63% specificity, respectively. Agreement on dual-stain positivity increased with greater numbers of p16/Ki-67-positive cells on the slides. Good to excellent reproducibility of p16/Ki-67 dual-stain cytology was observed with almost identical clinical performance of novice evaluators compared with reference evaluations. The current findings suggest that p16/Ki-67 dual-stain evaluation can be implemented in routine cytology practice with limited training. © 2014 American Cancer Society.

Online learning versus blended learning of clinical supervisee skills with pre-registration nursing students: A randomised controlled trial.

PubMed

McCutcheon, Karen; O'Halloran, Peter; Lohan, Maria

2018-06-01

The World Health Organisation amongst others recognises the need for the introduction of clinical supervision education in health professional education as a central strategy for improving patient safety and patient care. Online and blended learning methods are growing exponentially in use in higher education and the systematic evaluation of these methods will aid understanding of how best to teach clinical supervision. The purpose of this study was to test whether undergraduate nursing students who received clinical supervisee skills training via a blended learning approach would score higher in terms of motivation and attitudes towards clinical supervision, knowledge of clinical supervision and satisfaction of learning method, when compared to those students who received an online only teaching approach. A post-test-only randomised controlled trial. Participants were a total of 122 pre-registration nurses enrolled at one United Kingdom university, randomly assigned to the online learning control group (n = 60) or the blended learning intervention group (n = 62). The blended learning intervention group participated in a face-to-face tutorial and the online clinical supervisee skills training app. The online learning control group participated in an online discussion forum and the same online clinical supervisee skills training app. The outcome measures were motivation and attitudes using the modified Manchester Clinical Supervision Scale, knowledge using a 10 point Multiple Choice Questionnaire and satisfaction using a university training evaluation tool. Statistical analysis was performed using independent t-tests to compare the differences between the means of the control group and the intervention group. Thematic analysis was used to analyse responses to open-ended questions. All three of our study hypotheses were confirmed. Participants who received clinical supervisee skills training via a blended learning approach scored higher in terms of motivation and attitudes - mean (m) = 85.5, standard deviation (sd) = 9.78, number of participants (n) = 62 - compared to the online group (m = 79.5, sd = 9.69, n = 60) (p = .001). The blended learning group also scored higher in terms of knowledge (m = 4.2, sd = 1.43, n = 56) compared to the online group (m = 3.51, sd = 1.51, n = 57) (p = .015); and in terms of satisfaction (m = 30.89, sd = 6.54, n = 57) compared to the online group (m = 26.49, sd = 6.93, n = 55) (p = .001). Qualitative data supported results. Blended learning provides added pedagogical value when compared to online learning in terms of teaching undergraduate nurses clinical supervision skills. The evidence is timely given worldwide calls for expanding clinical skills supervision in undergraduate health professional education to improve quality of care and patient safety. Copyright © 2018 The Authors. Published by Elsevier Ltd.. All rights reserved.

Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

PubMed

Penberthy, Lynne; Brown, Richard; Puma, Federico; Dahman, Bassam

2010-05-01

Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials. This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Quantitative comparison of OSEM and penalized likelihood image reconstruction using relative difference penalties for clinical PET

NASA Astrophysics Data System (ADS)

Ahn, Sangtae; Ross, Steven G.; Asma, Evren; Miao, Jun; Jin, Xiao; Cheng, Lishui; Wollenweber, Scott D.; Manjeshwar, Ravindra M.

2015-08-01

Ordered subset expectation maximization (OSEM) is the most widely used algorithm for clinical PET image reconstruction. OSEM is usually stopped early and post-filtered to control image noise and does not necessarily achieve optimal quantitation accuracy. As an alternative to OSEM, we have recently implemented a penalized likelihood (PL) image reconstruction algorithm for clinical PET using the relative difference penalty with the aim of improving quantitation accuracy without compromising visual image quality. Preliminary clinical studies have demonstrated visual image quality including lesion conspicuity in images reconstructed by the PL algorithm is better than or at least as good as that in OSEM images. In this paper we evaluate lesion quantitation accuracy of the PL algorithm with the relative difference penalty compared to OSEM by using various data sets including phantom data acquired with an anthropomorphic torso phantom, an extended oval phantom and the NEMA image quality phantom; clinical data; and hybrid clinical data generated by adding simulated lesion data to clinical data. We focus on mean standardized uptake values and compare them for PL and OSEM using both time-of-flight (TOF) and non-TOF data. The results demonstrate improvements of PL in lesion quantitation accuracy compared to OSEM with a particular improvement in cold background regions such as lungs.

Diagnosis of vulvovaginitis: comparison of clinical and microbiological diagnosis.

PubMed

Esim Buyukbayrak, Esra; Kars, Bulent; Karsidag, Ayse Yasemin Karageyim; Karadeniz, Bernan Ilkay; Kaymaz, Ozge; Gencer, Serap; Pirimoglu, Zehra Meltem; Unal, Orhan; Turan, Mehmet Cem

2010-11-01

The purpose of the present study was to compare the current diagnostic clinical and laboratory approaches to women with vulvovaginal discharge complaint. The secondary outcomes were to determine the prevalence of infections in our setting and to look for the relation between vulvovaginal infections and predisposing factors if present. Premenopausal women applying to our gynecology outpatient clinic with vaginal discharge complaint were enrolled prospectively into the study. Each patient evaluated clinically with direct observation of vaginal secretions, wet mount examination, whiff test, vaginal pH testing and chlamydia rapid antigen test. Each patient also evaluated microbiologically with vaginal discharge culture and gram staining. Clinical diagnosis was compared with the microbiological diagnosis (the gold standard). Diagnostic accuracy was measured with sensitivity, specificity, positive (ppv) and negative predictive values (npv). 460 patients were included in the study. 89.8% of patients received a clinical diagnosis whereas only 36% of them had microbiological diagnosis. The sensitivity, specificity, ppv, npv of clinical diagnosis over microbiological culture results were 95, 13, 38, 82%, respectively. The most commonly encountered microorganisms by culture were Candida species (17.4%) and Gardnerella vaginalis (10.2%). Clinically, the most commonly made diagnoses were mixed infection (34.1%), bacterial vaginosis (32.4%) and fungal infection (14.1%). Symptoms did not predict laboratory results. Predisposing factors (DM, vaginal douching practice, presence of IUD and usage of oral contraceptive pills) were not found to be statistically important influencing factors for vaginal infections. Clinical diagnosis based on combining symptoms with office-based testing improves diagnostic accuracy but is insufficient. The most effective approach also incorporates laboratory testing as an adjunct when a diagnosis is in question or treatment is failing.

Implementing a pilot leadership course for internal medicine residents: design considerations, participant impressions, and lessons learned.

PubMed

Blumenthal, Daniel M; Bernard, Ken; Fraser, Traci N; Bohnen, Jordan; Zeidman, Jessica; Stone, Valerie E

2014-11-30

Effective clinical leadership is associated with better patient care. We implemented and evaluated a pilot clinical leadership course for second year internal medicine residents at a large United States Academic Medical Center that is part of a multi-hospital health system. The course met weekly for two to three hours during July, 2013. Sessions included large group discussions and small group reflection meetings. Topics included leadership styles, emotional intelligence, and leading clinical teams. Course materials were designed internally and featured "business school style" case studies about everyday clinical medicine which explore how leadership skills impact care delivery. Participants evaluated the course's impact and quality using a post-course survey. Questions were structured in five point likert scale and free text format. Likert scale responses were converted to a 1-5 scale (1 = strongly disagree; 3 = neither agree nor disagree; 5 = strongly agree), and means were compared to the value 3 using one-way T-tests. Responses to free text questions were analyzed using the constant comparative method. All sixteen pilot course participants completed the survey. Participants overwhelmingly agreed that the course provided content and skills relevant to their clinical responsibilities and leadership roles. Most participants also acknowledged that taking the course improved their understanding of their strengths and weaknesses as leaders, different leadership styles, and how to manage interpersonal conflict on clinical teams. 88% also reported that the course increased their interest in pursuing additional leadership training. A clinical leadership course for internal medicine residents designed by colleagues, and utilizing case studies about clinical medicine, resulted in significant self-reported improvements in clinical leadership competencies.

Using the implicit relational assessment procedure to compare implicit pro-thin/anti-fat attitudes of patients with anorexia nervosa and non-clinical controls.

PubMed

Parling, Thomas; Cernvall, Martin; Stewart, Ian; Barnes-Holmes, Dermot; Ghaderi, Ata

2012-01-01

Implicit pro-thin/anti-fat attitudes were investigated among a mixed group of patients with full and sub-threshold Anorexia Nervosa (n = 17), and a matched-age control group (n = 17). The Implicit Relational Assessment Procedure (IRAP) was employed to measure implicit pro-thin and anti-fat attitudes towards Self and Others in addition to "striving for thinness" and "avoidance of fatness." The clinical group showed an implicit pro-fat attitude towards Others and stronger anti-fat attitudes towards Self and avoidance of fatness compared with controls. The findings are discussed in relation to the over-evaluation of weight and shape in the clinical group.

A noninferiority clinical trial comparing fluconazole and ketoconazole in combination with cephalexin for the treatment of dogs with Malassezia dermatitis.

PubMed

Sickafoose, L; Hosgood, G; Snook, T; Westermeyer, R; Merchant, S

2010-01-01

This double-blinded noninferiority clinical trial evaluated the use of oral fluconazole for the treatment of Malassezia dermatitis in dogs by comparing it with use of an accepted therapeutic agent, ketoconazole. Dogs presenting with Malassezia dermatitis were treated with either fluconazole or ketoconazole in addition to cephalexin for concurrent bacterial dermatitis. Statistically significant improvements in cytologic yeast count, clinical signs associated with Malassezia dermatitis, and pruritus were seen with both antifungal treatments. There was no statistical difference between the treatments with regard to the magnitude of reduction in these parameters. These results suggest that fluconazole is at least as effective as ketoconazole for the treatment of dogs with Malassezia dermatitis.

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

Impact of different concentrations of an octenidine dihydrochloride mouthwash on salivary bacterial counts: a randomized, placebo-controlled cross-over trial.

PubMed

Lorenz, Katrin; Jockel-Schneider, Yvonne; Petersen, Nicole; Stölzel, Peggy; Petzold, Markus; Vogel, Ulrich; Hoffmann, Thomas; Schlagenhauf, Ulrich; Noack, Barbara

2018-03-02

This bi-centric, placebo-controlled, randomized, evaluator-blinded, incomplete cross-over clinical phase II trial was initialized to identify the most appropriate concentration of octenidine dihydrochloride (OCT) in mouth rinses. Rinses of 0.10, 0.15, and 0.20% OCT were compared to a saline placebo rinse regarding the reduction of salivary bacterial counts (SBCs) in 90 gingivitis patients over 4 days. Changes in plaque (PI) and gingival index (GI), taste perception, and safety issues were evaluated. At baseline, the first OCT (0.10, 0.15, 0.20%) rinse resulted in a decrease of SBC (reduction by 3.63-5.44 log 10 colony forming units [CFU]) compared to placebo (p < 0.001). Differences between OCT concentrations were not verified. After 4 days, the last OCT rinse again resulted in a significant SBC decrease (3.69-4.22 log 10 CFU) compared to placebo (p < 0.001). Overall, SBC reduction between baseline and day 4 was significantly higher in OCT 0.15 and 0.20% groups compared to OCT 0.10% and placebo. Mean GI/PIs were significantly lower in OCT groups than in the placebo group (p < 0.001). Differences in GI/PI between OCT groups were not verified. Adverse effects increased with increasing OCT concentrations. Considering antibacterial efficacy, frequency of adverse events, and user acceptance, 0.10% OCT was identified as the preferred concentration to be used in future clinical trials. Due to its low toxicity and pronounced antibacterial properties, octenidine dihydrochloride (OCT) is a promising candidate for the use in antiseptic mouth rinses. OCT concentrations of 0.10% are recommended for future clinical trials evaluating the plaque-reducing properties of OCT mouth rinses. ( www.clinicaltrials.gov , NCT022138552).

Assessment and clinical implications of cognitive impairment in acutely ill geriatric patients using a revised simplified short-term memory recall test (STMT-R).

PubMed

Yamamoto, Hiroshi; Ogawa, Kenichi; Huaman Battifora, Henry; Yamamuro, Kaori; Ishitake, Tatsuya

2018-05-24

Cognitive dysfunction due to delirium or dementia is a common finding in acutely ill geriatric patients, but often remains undetected. A brief and sensitive clinical identification method could prevent errors or complications while evaluating the mental status of elderly patients. To evaluate the usefulness and clinical implications of the revised simplified short-term memory recall test (STMT-R) in geriatric patients admitted in the emergency department; with age, gender, dementia history, serum albumin, underlying diseases and clinical outcome used as comparative factors. Mini-mental state examination and STMT-R scores were initially compared and a positive correlation was observed (r = 0.66, p < 0.001). Subsequently, 885 inpatients aged over 50 years underwent STMT-R evaluation between October 2014 and September 2015. We considered as cognitive dysfunction STMT-R scores ≤ 4 of a maximum score of 8. Among enrolled patients, 52.2% were female and the mean age was 78.9 years. There were 159 patients who were unable to complete the test (incomplete testing group). We observed cognitive dysfunction in 460 patients, while 266 did not have cognitive dysfunction. There were significant differences between those with and without cognitive dysfunction in terms of age, dementia history, underlying respiratory diseases, and hospital outcome. Cognitive dysfunction at admission can have a negative effect on the hospital outcomes of elderly patients. Age, a history of dementia and underlying respiratory diseases may also influence cognitive functional decline.

Clinical and arthroscopic outcome of single bundle anterior cruciate ligament reconstruction: Comparison of remnant preservation versus conventional technique.

PubMed

Choi, Sungwook; Kim, Myung-Ku; Kwon, Yong Suk; Kang, Hyunseong

2017-10-01

The purpose of this study was to compare the clinical outcomes and second-look arthroscopic findings of remnant preservation technique with those of conventional anterior cruciate ligament (ACL) reconstruction in single bundle ACL reconstructions. One hundred sixty two consecutive patients underwent ACL reconstruction by one surgeon, with 93 patients receiving remnant preservation technique (Group A) and 69 patients receiving conventional ACL reconstruction (Group B). The mean follow-up was 15months. Clinical outcomes were assessed using Lysholm scores and the International Knee Documentation Committee form (IKDC form) evaluation. Post-operative knee stability was evaluated through manual knee laxity evaluation, pivot-shift test, and a Telos device. Differences in post-operative stability (manual knee laxity, pivot shift test and Telos device) were not significant between the groups (p=0.681, p=0.610, p=0.696). And also no significant differences were noted with respect to the IKDC form and the latest Lysholm scores. But in the second-look arthroscopic findings, synovial coverage was confirmed to be excellent in 36% (22/61) of Group A patients and 23% (7/30) of Group B patients. ACL reconstruction with both techniques was found to result in acceptable stability, clinical outcomes and second-look arthroscopic findings. With regard to synovial coverage, the remnant reservation techniques were found to be superior to conventional ACL reconstruction. Level III, retrospective comparative study. Copyright © 2017 Elsevier B.V. All rights reserved.

Mapping ASTI patient’s therapeutic-data model to virtual Medical Record: can VMR represent therapeutic data elements used by ASTI in clinical guideline implementations?

PubMed Central

Ebrahiminia, Vahid; Yasini, Mobin; Lamy, Jean Baptiste

2013-01-01

Lack of interoperability between health information systems is a major obstacle in implementing Clinical decision supports systems (CDSS) and their widespread disseminations. Virtual Medical Record (vMR) proposed by HL7 is a common data model for representing clinical information Inputs and outputs that can be used by CDSS and local clinical systems. A CDSS called ASTI used a similar model to represent clinical data and therapeutic history of patient. In order to evaluate the compatibility of ASTI with vMR, we started to map the ASTI model of representing patient’s therapeutic data to vMR. We compared the data elements and associated terminologies used in ASTI and vMR and we evaluated the semantic fidelity between the models. Only one data element the qualitative description of drug dosage, did not match the vMR model. However, it can be calculated in the execution engine. The semantic fidelity was satisfactorily preserved in 12 of 17 elements mapped between the models. This model of ASTI seems compatible to vMR. Further work is necessary to evaluate the compatibility of clinical data model of ASTI to vMR and the use of vMR in implementing practice guidelines. PMID:24551344

Assessment of cytologic evaluation of preputial epithelial cells as a diagnostic test for detection of adrenocortical disease in castrated ferrets.

PubMed

Protain, Holly J; Kutzler, Michelle A; Valentine, Beth A

2009-05-01

To determine whether results of cytologic evaluation of preputial epithelial cells correspond to results of a serum endocrine hormone assay and clinical signs associated with adrenocortical disease in castrated ferrets. 13 clinically normal ferrets and 8 ferrets with signs of adrenocortical disease. Blood and preputial lavage samples were collected from each ferret. Serum samples were submitted to the University of Tennessee Veterinary Diagnostic Laboratory for performance of an endocrine hormone assay. Differential epithelial cell counts were performed on preputial lavage samples to determine the percentage of cornified cells. Results of cytologic evaluation were compared with results of the endocrine hormone assay and clinical status of ferrets. The percentage of cornified preputial epithelial cells was not significantly correlated with serum 17B-estradiol or androstenedione concentration but was significantly correlated with serum 17-hydroxyprogesterone concentration (r = 0.60). The percentage of cornified preputial epithelial cells was higher in ferrets with clinical signs of adrenocortical disease (mean +/- SD, 71.3 +/- 16.9%) than in clinically normal ferrets (55.5 +/- 19.0%). Cornification of preputial epithelial cells was correlated with an increase in serum 17-hydroxyprogesterone concentration as well as clinical signs of adrenocortical disease in castrated ferrets. Additional investigation is needed to elucidate the mechanism of preputial epithelial cell cornification in castrated ferrets.

Tissue engineering of the bladder--reality or myth? A systematic review.

PubMed

Sloff, Marije; Simaioforidis, Vasileios; de Vries, Rob; Oosterwijk, Egbert; Feitz, Wout

2014-10-01

We systematically reviewed preclinical studies in the literature to evaluate the potential of tissue engineering of the bladder. Study outcomes were compared to the available clinical evidence to assess the feasibility of tissue engineering for future clinical use. Preclinical studies of tissue engineering for bladder augmentation were identified through a systematic search of PubMed and Embase™ from January 1, 1980 to January 1, 2014. Primary studies in English were included if bladder reconstruction after partial cystectomy was performed using a tissue engineered biomaterial in any animal species, with cystometric bladder capacity as an outcome measure. Outcomes were compared to clinical studies available at http://www.clinicaltrials.gov and published clinical studies. A total of 28 preclinical studies are included, demonstrating remarkable heterogeneity in study characteristics and design. Studies in which preoperative bladder volumes were compared to postoperative volumes were considered the most clinically relevant (18 studies). Bladder augmentation through tissue engineering resulted in a normal bladder volume in healthy animals, with the influence of a cellular component being negligible. Furthermore, experiments in large animal models (pigs and dogs) approximated the desired bladder volume more accurately than in smaller species. The initial clinical experience was based on seemingly predictive healthy animal models with a promising outcome. Unfortunately these results were not substantiated in all clinical trials, revealing dissimilar outcomes in different clinical/disease backgrounds. Thus, the translational predictability of a model using healthy animals might be questioned. Through this systematic approach we present an unbiased overview of all published preclinical studies investigating the effect of bladder tissue engineering on cystometric bladder capacity. Preclinical research in healthy animals appears to show the feasibility of bladder augmentation by tissue engineering. However, in view of the disappointing clinical results based on healthy animal models new approaches should also be evaluated in preclinical models using dysfunctional/diseased bladders. This endeavor may aid in the development of clinically applicable tissue engineered bladder augmentation with satisfactory long-term outcome. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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

A proposed CT contrast agent using carboxybetaine zwitterionic tantalum oxide nanoparticles: Imaging, biological, and physicochemical performance

PubMed Central

FitzGerald, Paul F.; Butts, Matthew D.; Roberts, Jeannette C.; Colborn, Robert E.; Torres, Andrew S.; Lee, Brian D.; Yeh, Benjamin M.; Bonitatibus, Peter J.

2016-01-01

Objectives To produce and evaluate a proposed computed tomography (CT) contrast agent based on carboxybetaine zwitterionic (CZ) coated soluble tantalum oxide nanoparticles (CZ-TaO NPs). We chose tantalum to provide superior imaging performance compared to current iodine-based clinical CT contrast agents. We developed the CZ coating to provide biological and physical performance similar to that of current iodinated contrast agents. The aim of this study was to evaluate the imaging, biological, and physicochemical performance of this proposed contrast agent compared to clinically-used iodinated agents. Materials and Methods We evaluated CT imaging performance of our CZ-TaO NPs compared to an iodinated agent in live rats, imaged centrally-located within a tissue-equivalent plastic phantom that simulated a large patient. To evaluate vascular contrast enhancement, we scanned the rats’ great vessels at high temporal resolution during and following contrast agent injection. We performed several in vivo CZ-TaO NP studies in healthy rats to evaluate tolerability. These studies included injecting the agent at the anticipated clinical dose (ACD) and at 3 times and 6 times the ACD, followed by longitudinal hematology to assess impact to blood cells and organ function (from 4 hours to 1 week). Kidney histological analysis was performed 48 hours after injection at 3 times the ACD. We measured the elimination half-life of CZ-TaO NPs from blood, and we monitored acute kidney injury biomarkers with a kidney injury assay using urine collected from 4 hours to 1 week. We measured tantalum retention in individual organs and in the whole carcass 48 hours after injection at ACD. CZ-TaO NPs were synthesized and analyzed in detail. We used multi-dimensional nuclear magnetic resonance (NMR) to determine surface functionality of the nanoparticles. We measured nanoparticle size and solution properties (osmolality and viscosity) of the agent over a range of tantalum concentrations, including the high concentrations required for standard clinical CT imaging. Results CT imaging studies demonstrated image contrast improvement of approximately 40–50% using CZ-TaO NPs compared with an iodinated agent injected at the same mass concentration. Blood and organ analyses showed no adverse effects following injection in healthy naïve rats at 3 times the ACD. Retention of tantalum at 48 hours after injection was less than 2% of the injected dose in the whole carcass, which very closely matched the reported retention of existing commercial iodine-based contrast agents. Urine analysis of sensitive markers for acute kidney injury showed no responses at 1 week following injection at 3 times the ACD; however, a moderate response in the neutrophil gelatinase-associated lipocalin (NGAL) biomarker was measured at 24 and 48 hours. Compared to other tantalum oxide nanoparticles reported in the literature, CZ-TaO NPs had relatively low osmolality and viscosity at concentrations >200 mg Ta/mL, and were similar in these physical properties to dimeric iodine-based contrast agents. Conclusions We found that a CZ-TaO NP-based contrast agent is potentially viable for general-purpose clinical CT imaging. Our results suggest that such an agent can be formulated with clinically-viable physicochemical properties, can be biologically safe and cleared rapidly in urine, and can provide substantially improved image contrast at CT compared to current iodinated agents. PMID:27115702

A Proposed Computed Tomography Contrast Agent Using Carboxybetaine Zwitterionic Tantalum Oxide Nanoparticles: Imaging, Biological, and Physicochemical Performance.

PubMed

FitzGerald, Paul F; Butts, Matthew D; Roberts, Jeannette C; Colborn, Robert E; Torres, Andrew S; Lee, Brian D; Yeh, Benjamin M; Bonitatibus, Peter J

2016-12-01

The aim of this study was to produce and evaluate a proposed computed tomography (CT) contrast agent based on carboxybetaine zwitterionic (CZ)-coated soluble tantalum oxide (TaO) nanoparticles (NPs). We chose tantalum to provide superior imaging performance compared with current iodine-based clinical CT contrast agents. We developed the CZ coating to provide biological and physical performance similar to that of current iodinated contrast agents. In addition, the aim of this study was to evaluate the imaging, biological, and physicochemical performance of this proposed contrast agent compared with clinically used iodinated agents. We evaluated CT imaging performance of our CZ-TaO NPs compared with that of an iodinated agent in live rats, imaged centrally located within a tissue-equivalent plastic phantom that simulated a large patient. To evaluate vascular contrast enhancement, we scanned the rats' great vessels at high temporal resolution during and after contrast agent injection. We performed several in vivo CZ-TaO NP studies in healthy rats to evaluate tolerability. These studies included injecting the agent at the anticipated clinical dose (ACD) and at 3 times and 6 times the ACD, followed by longitudinal hematology to assess impact to blood cells and organ function (from 4 hours to 1 week). Kidney histological analysis was performed 48 hours after injection at 3 times the ACD. We measured the elimination half-life of CZ-TaO NPs from blood, and we monitored acute kidney injury biomarkers with a kidney injury assay using urine collected from 4 hours to 1 week. We measured tantalum retention in individual organs and in the whole carcass 48 hours after injection at ACD. Carboxybetaine zwitterionic TaO NPs were synthesized and analyzed in detail. We used multidimensional nuclear magnetic resonance to determine surface functionality of the NPs. We measured NP size and solution properties (osmolality and viscosity) of the agent over a range of tantalum concentrations, including the high concentrations required for standard clinical CT imaging. Computed tomography imaging studies demonstrated image contrast improvement of approximately 40% to 50% using CZ-TaO NPs compared with an iodinated agent injected at the same mass concentration. Blood and organ analyses showed no adverse effects after injection in healthy naive rats at 3 times the ACD. Retention of tantalum at 48 hours after injection was less than 2% of the injected dose in the whole carcass, which very closely matched the reported retention of existing commercial iodine-based contrast agents. Urine analysis of sensitive markers for acute kidney injury showed no responses at 1 week after injection at 3 times the ACD; however, a moderate response in the neutrophil gelatinase-associated lipocalin biomarker was measured at 24 and 48 hours. Compared with other TaO NPs reported in the literature, CZ-TaO NPs had relatively low osmolality and viscosity at concentrations greater than 200 mg Ta/mL and were similar in these physical properties to dimeric iodine-based contrast agents. We found that a CZ-TaO NP-based contrast agent is potentially viable for general-purpose clinical CT imaging. Our results suggest that such an agent can be formulated with clinically viable physicochemical properties, can be biologically safe and cleared rapidly in urine, and can provide substantially improved image contrast at CT compared with current iodinated agents.

Cyclosporine and ketoconazole for the treatment of perianal fistulas in dogs.

PubMed

Patricelli, Alison J; Hardie, Robert J; McAnulty, Jonathan E

2002-04-01

To evaluate efficacy and cost of using cyclosporine and ketoconazole for the treatment of perianal fistulas in dogs. Clinical trial. 12 dogs with perianal fistulas. Dogs received cyclosporine and ketoconazole orally (target whole blood trough cyclosporine concentrations of 400 to 600 ng/ml). Study endpoints were resolution of clinical signs, remission, and recurrence of disease. Adverse effects and cost of medications were reported. Results were compared with those from previous studies in humans and in dogs in which single agent cyclosporine treatment for perianal fistulas was used. All dogs had resolution of clinical signs. Eight dogs went into remission; however, 5 of those 8 had recurrence of fistulas. Adverse effects of treatment were minimal and well tolerated. Cost of treatment was comparable to traditional surgical options and less than single agent cyclosporine treatment. Administration of cyclosporine with ketoconazole is an effective and cost-comparable treatment for perianal fistulas in dogs.

Contrast enhanced Gd-DTPA magnetic resonance imaging in the evaluation of rheumatoid arthritis during a clinical trial with DMARDs. A prospective two-year follow-up study on hand joints in 31 patients.

PubMed

Jevtic, V; Watt, I; Rozman, B; Kos-Golja, M; Praprotnik, S; Logar, D; Presetnik, M; Demsar, F; Jarh, O; Campion, G; Musikic, P

1997-01-01

The aim of this prospective 24-month follow-up study was to compare clinical features with radiological and magnetic resonance imaging (MRI) findings in evaluating synovial proliferation in the hand joints of 31 patients with rheumatoid arthritis (RA). A single joint was used for the follow-up of each patient. Thirty-one small hand joints were examined by conventional radiography and MRI before and after 24 months of treatment. MRI assessment of disease progression (volume and/or signal intensity of the synovial proliferation on T1 weighted precontrast, T1 weighted postcontrast and T2 weighted images) was compared with a clinical assessment of the chosen joints, and with a plain x-ray film evaluation (Larsen's score). Of 26 joints which clinically improved (14 markedly and 14 slightly) during the study, on MRI 16 showed improvement, 8 showed no change, and 2 showed deterioration. Four clinically unchanged joints appeared improved on MRI. One joint deteriorated clinically and on MRI. Overall, there was a 58% congruence between clinical and MRI findings. On x-ray 23 joints showed no change; nine of these were also unchanged on MRI, while 13 showed improvement and one deterioration. Only in 2 out of 8 joints showing deterioration on x-ray were the MRI findings in accordance. In the remaining six joints MRI showed improvement. The congruence between x-ray and MRI was therefore 36%. The long-term follow-up of rheumatoid synovial proliferation of the small joints in the hand using contrast enhanced MRI is feasible and may provide additional information regarding disease activity. Important advantages over conventional radiography methods are its ability to demonstrate qualitative differences of synovial proliferation within bone erosions, and demonstrate not only deterioration, but also the improvement of inflammatory disease.

[THE TRUE OR FALSE BACTERIEMIA: THE SIGNIFICANCE OF EVALUATION CRITERIA OF CLINICAL SIGNIFICANCE OF POSITIVE HEMOCULTURE].

PubMed

Bagirova, N S

2015-08-01

The diagnostic of infections of blood flow using technique of hemofermentation (blood inoculation) is one of the most significant functions of laboratory of clinical microbiology. The effectiveness of the given technique depends on many factors, including criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism applied by physician-microbiologist. The intelligent analysis of received results is needed. The physician-microbiologist has to determine if microorganism isolated from given blood sample, is a genuine agent of infections of bloodflow or it is only effect of contamination of analyzed sample at certain stage. The article presents data concerning taxonomic structure of microorganisms isolated under episodes of bacteriemia of adult oncologic hematologic patients during 2005-2013. The criteria of evaluation of clinical significance of episode of bacteriemia and isolated microorganism are described. The given criteria are developed in the N.N. Blokhin Russian oncological research center and are applied since 1977. The cases of contamination and genuine bacteriemia are established. The comparative analysis of international data and results of one's own study are carried out.

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.

Vitamin C with metabolites reduce oxalate levels compared to ascorbic acid: a preliminary and novel clinical urologic finding.

PubMed

Moyad, Mark A; Combs, Maile A; Crowley, David C; Baisley, Joshua E; Sharma, Prachi; Vrablic, Angelica S; Evans, Malkanthi

2009-01-01

The incidence and prevalence of kidney stones are notable and are projected to increase over the next decade. Risk factors for kidney stones abound, but a prominent risk factor is hyperoxaluria, which has numerous etiologies, including vitamin C (ascorbic acid) dietary supplement intake. This randomized, double-blind, crossover study examined the effects of two different vitamin C formulations and found that vitamin C with metabolites (Ester-C) significantly reduced urine oxalate levels compared to ascorbic acid. This is a potential novel finding that requires further clinical evaluation.

Goldmann tonometer error correcting prism: clinical evaluation.

PubMed

McCafferty, Sean; Lim, Garrett; Duncan, William; Enikov, Eniko T; Schwiegerling, Jim; Levine, Jason; Kew, Corin

2017-01-01

Clinically evaluate a modified applanating surface Goldmann tonometer prism designed to substantially negate errors due to patient variability in biomechanics. A modified Goldmann prism with a correcting applanation tonometry surface (CATS) was mathematically optimized to minimize the intraocular pressure (IOP) measurement error due to patient variability in corneal thickness, stiffness, curvature, and tear film adhesion force. A comparative clinical study of 109 eyes measured IOP with CATS and Goldmann prisms. The IOP measurement differences between the CATS and Goldmann prisms were correlated to corneal thickness, hysteresis, and curvature. The CATS tonometer prism in correcting for Goldmann central corneal thickness (CCT) error demonstrated a reduction to <±2 mmHg in 97% of a standard CCT population. This compares to only 54% with CCT error <±2 mmHg using the Goldmann prism. Equal reductions of ~50% in errors due to corneal rigidity and curvature were also demonstrated. The results validate the CATS prism's improved accuracy and expected reduced sensitivity to Goldmann errors without IOP bias as predicted by mathematical modeling. The CATS replacement for the Goldmann prism does not change Goldmann measurement technique or interpretation.

Psychological, behavioral, and clinical effects of intra-oral camera: a randomized control trial on adults with gingivitis.

PubMed

Araújo, Mário-Rui; Alvarez, Maria-João; Godinho, Cristina A; Pereira, Cícero

2016-12-01

To evaluate the effects of using an intra-oral camera (IOC) during supportive periodontal therapy (SPT), on the psychological, behavioral, and clinical parameters of patients with gingivitis, outlined by evidence and a theory-based framework. A group of 78 adult patients with gingivitis receiving an SPT was randomized into two groups: IOC and control. Bleeding on Marginal Probing (BOMP), self-reported dental hygiene behaviors, and psychological determinants of behavior change (outcome expectancies, self-efficacy, and planning) and IOC opinion were evaluated 1 week before or during the appointment and 4 months later. Repeated-measures anova was used to compare groups over time. Almost all the patients brushed their teeth daily, while 78% either never or hardly ever used dental floss. The IOC group showed significant improvements in BOMP index (P < 0.001), self-reported flossing (P < 0.05), and self-efficacy (P < 0.05) compared to the control group. The use of IOC significantly improves clinical, behavioral, and psychological determinants of periodontal health 4 months after treatment. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The efficacy of intra-articularly administered MYC 2095, triamcinolone hexacetonide and placebo in gonarthritis. A combined double-blind clinical trial.

PubMed

Cats, A; van IJzerloo, J A; Davinova, Y; Werthauer-Rodrigues Pereira, M; Blakemore, C B; Steiner, F J

1979-01-01

We report the results of a double-blind three-centre study, employing a cross-over design, set up to compare the efficacy of intra-articular injections of Myc 2095 (20 mg), triamcinolone hexacetonide (Lederspan) (20 mg) and placebo in 40 patients with synovitis of the knee joint. Each patient included in the study contributed data on 2 of the 3 treatment variables being compared. Seven clinical parameters were assessed every 6 weeks, while the doctor's and the patient's assessments were scored. Intra articular treatment both with Myc 2095 and triamcinolone hexacetonide proved to be effective. Placebo response was also very high. After the first Myc 2095 injection, improvement in "tenderness", "pain under load" and "swelling and hydrops" was significantly superior to that following placebo treatment. The evaluation of the second injections indicated a marked carry-over effect from the first course. This was also evident from the doctor's and patient's assessments. The importance of including a placebo in the evaluation of anti-phlogistic drugs in clinical trials, emerged from this study.

Mineral trioxide aggregate versus calcium hydroxide for pulpotomy in primary molars.

PubMed

Liu, He; Zhou, Qiong; Qin, Man

2011-01-01

To compare the effects of mineral trioxide aggregate (MTA) and calcium hydroxide (CH) for pulpotomy in primary molars. A randomised, bilateral self-controlled clinical trial was designed to compare the clinical effect of MTA and CH in pulpotomies in primary molars in 4- to 9-year-old children. Children with two similar-sized cavities on bilateral primary molar counterparts requiring pulpotomies were included. The two contralateral molars in each patient were randomly assigned to MTA or CH treatment. Clinical and radiographic examinations were performed to evaluate the treatment results at post-treatment recall. Seventeen pairs of self-controlled contralateral teeth were available for follow-up evaluations. The success rate of MTA was 94.1% (16/17), while the success rate of CH was 64.7% (11/17). Internal root resorption was the most frequent reason for failure in the CH group. Crown discolouration was common in the MTA-treated group. MTA was more successful than CH for pulpotomies in primary molar teeth, and may be a suitable replacement for CH in primary molar pulpotomies.

Addressing the expected survival benefit for clinical trial design in metastatic castration-resistant prostate cancer: Sensitivity analysis of randomized trials.

PubMed

Massari, Francesco; Modena, Alessandra; Ciccarese, Chiara; Pilotto, Sara; Maines, Francesca; Bracarda, Sergio; Sperduti, Isabella; Giannarelli, Diana; Carlini, Paolo; Santini, Daniele; Tortora, Giampaolo; Porta, Camillo; Bria, Emilio

2016-02-01

We performed a sensitivity analysis, cumulating all randomized clinical trials (RCTs) in which patients with metastatic castration-resistant prostate cancer (mCRPC) received systemic therapy, to evaluate if the comparison of RCTs may drive to biased survival estimations. An overall survival (OS) significant difference according to therapeutic strategy was more likely be determined in RCTs evaluating hormonal drugs versus those studies testing immunotherapy, chemotherapy or other strategies. With regard to control arm, an OS significant effect was found for placebo-controlled trials versus studies comparing experimental treatment with active therapies. Finally, regarding to docetaxel (DOC) timing, the OS benefit was more likely to be proved in Post-DOC setting in comparison with DOC and Pre-DOC. These data suggest that clinical trial design should take into account new benchmarks such as the type of treatment strategy, the choice of the comparator and the phase of the disease in relation to the administration of standard chemotherapy. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

[Pelargonium sidoides in acute bronchitis - Health-related quality of life and patient-reported outcome in adults receiving EPs 7630 treatment].

PubMed

Matthys, Heinrich; Lizogub, Victor G; Funk, Petra; Malek, Fathi A

2010-12-01

Health-related quality of life (HRQL) and patient-reported outcome (PRO) have become important outcome parameters for the evaluation of medical treatment within clinical trials and, furthermore, to evaluate efficiency in clinical practice. We therefore report further exploratory results of an already reported dose-finding study with EPs 7630 tablets, now focussing on HRQL and PRO. A total of 406 adults with acute bronchitis were randomly assigned to one of four parallel treatment groups (placebo, 30 mg, 60 mg or 90 mg EPs 7630 daily). HRQL and PRO were assessed by questionnaires as secondary outcome measures at each study visit or daily in the patient's diary. At day 7, the patient-reported outcome measures were significantly more improved in all the three EPs 7630 groups compared to placebo (EQ-5D and EQ VAS, SF-12: physical score, impact of patient's sickness, duration of activity limitation, patient-reported treatment outcome, satisfaction with treatment). In conclusion, a statistically significant and clinically relevant improvement of HRQL/PRO compared to placebo was shown in all the three EPs 7630 groups.

Assessing Traumatic Event Exposure: Comparing the Traumatic Life Events Questionnaire to the Structured Clinical Interview for "DSM-IV"

ERIC Educational Resources Information Center

Peirce, Jessica M.; Burke, Christopher K.; Stoller, Kenneth B.; Neufeld, Karin J.; Brooner, Robert K.

2009-01-01

Post-traumatic stress disorder (PTSD) diagnosis requires first identifying a traumatic event, but very few studies have evaluated methods of potential traumatic event assessment and their impact on PTSD diagnosis. The authors compared a behaviorally specific comprehensive multiple-item traumatic event measure with a single-item measure to…

Redesign of a computerized clinical reminder for colorectal cancer screening: a human-computer interaction evaluation

PubMed Central

2011-01-01

Background Based on barriers to the use of computerized clinical decision support (CDS) learned in an earlier field study, we prototyped design enhancements to the Veterans Health Administration's (VHA's) colorectal cancer (CRC) screening clinical reminder to compare against the VHA's current CRC reminder. Methods In a controlled simulation experiment, 12 primary care providers (PCPs) used prototypes of the current and redesigned CRC screening reminder in a within-subject comparison. Quantitative measurements were based on a usability survey, workload assessment instrument, and workflow integration survey. We also collected qualitative data on both designs. Results Design enhancements to the VHA's existing CRC screening clinical reminder positively impacted aspects of usability and workflow integration but not workload. The qualitative analysis revealed broad support across participants for the design enhancements with specific suggestions for improving the reminder further. Conclusions This study demonstrates the value of a human-computer interaction evaluation in informing the redesign of information tools to foster uptake, integration into workflow, and use in clinical practice. PMID:22126324

Patellar cartilage lesions: comparison of magnetic resonance imaging and T2 relaxation-time mapping.

PubMed

Hannila, I; Nieminen, M T; Rauvala, E; Tervonen, O; Ojala, R

2007-05-01

To evaluate the detection and the size of focal patellar cartilage lesions in T2 mapping as compared to standard clinical magnetic resonance imaging (MRI) at 1.5T. Fifty-five consecutive clinical patients referred to knee MRI were imaged both with a standard knee MRI protocol (proton-density-weighted sagittal and axial series, T2-weighted sagittal and coronal series, and T1-weighted coronal series) and with an axial multislice multi-echo spin-echo measurement to determine the T2 relaxation time of the patellar cartilage. MR images and T2 maps of patellar cartilage were evaluated for focal lesions. The lesions were evaluated for lesion width (mm), lesion depth (1/3, 2/3, or 3/3 of cartilage thickness), and T2 value (20-40 ms, 40-60 ms, or 60-80 ms) based on visual evaluation. Altogether, 36 focal patellar cartilage lesions were detected from 20 human subjects (11 male, nine female, mean age 40+/-15 years). Twenty-eight lesions were detected both on MRI and T2 maps, while eight lesions were only visible on T2 maps. Cartilage lesions were significantly wider (P = 0.001) and thicker (P<0.001) on T2 maps as compared to standard knee MRI. Most lesions 27 had moderately (T2 40-60 ms) increased T2 values, while two lesions had slightly (T2 20-40 ms) and seven lesions remarkably (T2 60-80 ms) increased T2 relaxation times. T2 mapping of articular cartilage is feasible in the clinical setting and may reveal early cartilage lesions not visible with standard clinical MRI.

Alosetron use in clinical practice: significant improvement in irritable bowel syndrome symptoms evaluated using the US Food and Drug Administration composite endpoint.

PubMed

Lacy, Brian E; Nicandro, Jean Paul; Chuang, Emil; Earnest, David L

2018-01-01

Alosetron is approved to treat women with severe IBS and diarrhea (IBS-D) who have failed standard therapy. In our study, we aimed to evaluate alosetron efficacy using new US Food and Drug Administration (FDA) endpoints and utilization in clinical practice. This prospective, open-label, multicenter, observational 12-week study evaluated women with severe IBS-D enrolled in the alosetron prescribing program. The coprimary FDA endpoints were changes from baseline in stool consistency and abdominal pain severity. Responders achieved a 30% decrease compared with baseline in weekly average of the worst abdominal pain in the past 24 h, and a 50% or greater reduction from baseline in the number of days/week with at least one stool of type 6 (mushy) or type 7 (watery) consistency. Secondary endpoints included changes from baseline in stool frequency, fecal urgency and fecal incontinence. Enrolled patients ( n = 192) were primarily White (90.6%), with a mean age of 44.5 years. Patient and physician rating of IBS severity was between moderate and severe (85.9% concordance, Spearman coefficient 0.429, p < 0.0001). Alosetron 0.5 mg twice daily (82.8%) was the most common dosing regimen. A total of 152 alosetron-treated patients completed the study. Of 105 fully evaluable patients, 45% met the FDA composite endpoint responder criteria for ⩾50% of the study period. Improvements in all individual symptoms were statistically significant compared with baseline. There were no serious adverse events, cases of colonic ischemia, or complications of constipation. In a clinical practice setting study, alosetron demonstrated treatment success using a rigorous FDA composite endpoint and also improved multiple other IBS symptoms, including fecal urgency and incontinence in women with severe IBS-D [ClinicalTrials.gov identifier: NCT01257477].

Increasing referral of at-risk travelers to travel health clinics: evaluation of a health promotion intervention targeted to travel agents.

PubMed

MacDougall, L A; Gyorkos, T W; Leffondré, K; Abrahamowicz, M; Tessier, D; Ward, B J; MacLean, J D

2001-01-01

Increases in travel-related illness require new partnerships to ensure travelers are prepared for health risks abroad. The travel agent is one such partner and efforts to encourage travel agents to refer at-risk travelers to travel health clinics may help in reducing travel-attributable morbidity. A health promotion intervention encouraging travel agents to refer at-risk travelers to travel health clinics was evaluated. Information on the knowledge, attitudes, and behaviors of travel agents before and after the intervention was compared using two self-administered questionnaires. The Wilcoxon signed rank test was used to compare the mean difference in overall scores to evaluate the overall impact of the intervention and also subscores for each of the behavioral construct groupings (attitudes, barriers, intent, and subjective norms). Multiple regression techniques were used to evaluate which travel agent characteristics were independently associated with a stronger effect of the intervention. A small improvement in travel agents overall attitudes and beliefs (p =.03) was found, in particular their intention to refer (p =.01). Sixty-five percent of travel agents self-reported an increase in referral behavior; owners or managers of the agency were significantly more likely to do so than other travel agents (OR = 7.25; 95% CI: 1.64 32.06). Older travel agents, those that worked longer hours and those with some past referral experience, had significantly higher post-intervention scores. Travel agents can be willing partners in referral, and agencies should be encouraged to develop specific referral policies. Future research may be directed toward investigating the role of health education in certification curricula, the effectiveness of different types of health promotion interventions, including Internet-facilitated interventions, and the direct impact that such interventions would have on travelers attending travel health clinics.

Efficacy and Safety of Oritavancin Relative to Vancomycin for Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) in the Outpatient Setting: Results From the SOLO Clinical Trials.

PubMed

Lodise, Thomas P; Redell, Mark; Armstrong, Shannon O; Sulham, Katherine A; Corey, G Ralph

2017-01-01

The objective of this analysis was to evaluate the efficacy and safety of oritavancin compared with vancomycin for patients with acute bacterial skin and skin structure infections (ABSSSIs) who received treatment in the outpatient setting in the Phase 3 SOLO clinical trials. SOLO I and SOLO II were 2 identically designed comparative, multicenter, double-blind, randomized studies to evaluate the efficacy and safety of a single 1200-mg dose of intravenous (IV) oritavancin versus 7-10 days of twice-daily IV vancomycin for the treatment of ABSSSI. Protocols were amended to allow enrolled patients to complete their entire course of antimicrobial therapy in an outpatient setting. The primary efficacy outcome was a composite endpoint (cessation of spread or reduction in size of the baseline lesion, absence of fever, and no rescue antibiotic at early clinical evaluation [ECE]) (48 to 72 hours). Key secondary endpoints included investigator-assessed clinical cure 7 to 14 days after end of treatment (posttherapy evaluation [PTE]) and 20% or greater reduction in lesion area at ECE. Safety was assessed until day 60. Seven hundred ninety-two patients (oritavancin, 392; vancomycin, 400) received entire course of treatment in the outpatient setting. Efficacy response rates at ECE and PTE were similar (primary composite endpoint at ECE: 80.4% vs 77.5% for oritavancin and vancomycin, respectively) as was incidence of adverse events. Five patients (1.3%) who received oritavancin and 9 (2.3%) vancomycin patients were subsequently admitted to a hospital. Oritavancin provides a single-dose alternative to multidose vancomycin for treatment of ABSSSI in the outpatient setting. © The Author 2017. Published by Oxford University Press on behalf of Infectious Diseases Society of America.

Methodological Quality of Consensus Guidelines in Implant Dentistry.

PubMed

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions.

Methodological Quality of Consensus Guidelines in Implant Dentistry

PubMed Central

Faggion, Clovis Mariano; Apaza, Karol; Ariza-Fritas, Tania; Málaga, Lilian; Giannakopoulos, Nikolaos Nikitas; Alarcón, Marco Antonio

2017-01-01

Background Consensus guidelines are useful to improve clinical decision making. Therefore, the methodological evaluation of these guidelines is of paramount importance. Low quality information may guide to inadequate or harmful clinical decisions. Objective To evaluate the methodological quality of consensus guidelines published in implant dentistry using a validated methodological instrument. Methods The six implant dentistry journals with impact factors were scrutinised for consensus guidelines related to implant dentistry. Two assessors independently selected consensus guidelines, and four assessors independently evaluated their methodological quality using the Appraisal of Guidelines for Research & Evaluation (AGREE) II instrument. Disagreements in the selection and evaluation of guidelines were resolved by consensus. First, the consensus guidelines were analysed alone. Then, systematic reviews conducted to support the guidelines were included in the analysis. Non-parametric statistics for dependent variables (Wilcoxon signed rank test) was used to compare both groups. Results Of 258 initially retrieved articles, 27 consensus guidelines were selected. Median scores in four domains (applicability, rigour of development, stakeholder involvement, and editorial independence), expressed as percentages of maximum possible domain scores, were below 50% (median, 26%, 30.70%, 41.70%, and 41.70%, respectively). The consensus guidelines and consensus guidelines + systematic reviews data sets could be compared for 19 guidelines, and the results showed significant improvements in all domain scores (p < 0.05). Conclusions Methodological improvement of consensus guidelines published in major implant dentistry journals is needed. The findings of the present study may help researchers to better develop consensus guidelines in implant dentistry, which will improve the quality and trust of information needed to make proper clinical decisions. PMID:28107405

Initial clinical validation of Health Heritage, a patient-facing tool for personal and family history collection and cancer risk assessment.

PubMed

Baumgart, Leigh A; Postula, Kristen J Vogel; Knaus, William A

2016-04-01

Personal and family health histories remain important independent risk factors for cancer; however they are currently not being well collected or used effectively. Health Heritage was designed to address this need. The purpose of this study was to validate the ability of Health Heritage to identify patients appropriate for further genetic evaluation and to accurately stratify cancer risk. A retrospective chart review was conducted on 100 random patients seen at an adult genetics clinic presenting with concern for an inherited predisposition to cancer. Relevant personal and family history obtained from the patients' medical records was entered into Health Heritage. Recommendations by Health Heritage were compared to national guidelines of eligibility for genetic evaluation. Agreement between Health Heritage referral for genetic evaluation and guideline eligibility for genetic evaluation was 97% (sensitivity 98% and specificity 88%). Risk stratification for cancer was also compared between Health Heritage and those documented by a geneticist. For patients at increased risk for breast, ovarian, or colorectal cancer as determined by the geneticist, risk stratification by Health Heritage agreed 90, 93, and 75%, respectively. Discordances in risk stratification were attributed to both complex situations better handled by the geneticist and Health Heritage's adherence to incorporating all information into its algorithms. Health Heritage is a clinically valid tool to identify patients appropriate for further genetic evaluation and to encourage them to confirm the assessment and management recommendations with cancer genetic experts. Health Heritage also provides an estimate of cancer risk that is complementary to a genetics team.

Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

PubMed

Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna

2013-01-01

The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

Transient ischaemic attacks clinics provide equivalent and more efficient care than early in-hospital assessment.

PubMed

Martínez-Martínez, M M; Martínez-Sánchez, P; Fuentes, B; Cazorla-García, R; Ruiz-Ares, G; Correas-Callero, E; Lara-Lara, M; Díez-Tejedor, E

2013-02-01

Clinics for early management of transient ischaemic attacks (TIAs) have been developed in some stroke centres, resulting in reduced recurrence rates compared to appointment-based outpatient management, thus saving on hospitalization. We analysed the care process, recurrence rates and economic impact of the first year of work in our early-management TIA clinic and compared these with our previous in-hospital study protocols for low- and moderate-risk TIA patients. This was a prospective evaluation of the management of low- to moderate-risk TIA patients, comparing a new TIA clinic model (2010) with a previous hospitalization model (2009). Demographic data, vascular risk factor profiles, diagnostic test performance, secondary prevention measures, final aetiological diagnoses and cerebrovascular recurrences at 7 and 90 days were compared between in-hospital and TIA clinic assessed patients. We also carried out an economic comparison of the costs of each model's process. Two hundred and eleven low- to moderate-risk TIA patients were included, of whom 40.8% were hospitalized. There were no differences between the TIA clinic assessed and in-hospital assessed patients in terms of risk factor diagnosis and secondary prevention measures. The stroke recurrence rate (2.4% vs. 1.2%; P = 0.65) was low and similar for both groups (CI 95%, 0.214-20.436; P = 0.52). Cost per patient was €393.28 for clinic versus €1931.18 for in-hospital management. Outpatient management resulted in a 77.8% reduction in hospitalizations. Transient ischaemic attacks clinics are efficient for the early management of low- to moderate-risk TIA patients compared to in-hospital assessment, with no higher recurrence rates and at almost one-fifth the cost. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.

PubMed

Lowe, Nancy K; Neal, Jeremy L; Ryan-Wenger, Nancy A

2009-01-01

To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard. This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard. Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult. II.

Dasatinib, high-dose imatinib and nilotinib for the treatment of imatinib-resistant chronic myeloid leukaemia: a systematic review and economic evaluation.

PubMed

Loveman, E; Cooper, K; Bryant, J; Colquitt, J L; Frampton, G K; Clegg, A

2012-01-01

The present report was commissioned as a supplement to an existing technology assessment report produced by the Peninsula Technology Assessment Group (PenTAG), which evaluated the clinical effectiveness and cost-effectiveness of dasatinib and nilotinib in patients who are either resistant or intolerant to standard-dose imatinib. This report evaluates the clinical effectiveness and cost-effectiveness of dasatinib, nilotinib and high-dose imatinib within their licensed indications for the treatment of people with chronic myeloid leukaemia (CML) who are resistant to standard-dose imatinib. Bibliographic databases were searched from inception to January 2011, including The Cochrane Library, MEDLINE (Ovid), EMBASE (Ovid), and MEDLINE In-Process & Other Non-Indexed Citations. Bibliographies of related papers were screened, key conferences were searched, and experts were contacted to identify additional published and unpublished references. This report includes systematic reviews of clinical effectiveness and cost-effectiveness studies, an independent appraisal of information submitted by drug manufacturers to the National Institute for Health and Clinical Excellence (NICE), an independent appraisal of the PenTAG economic evaluation, and new economic analyses adapting the PenTAG economic model. Standard systematic procedures involving two reviewers to maintain impartiality and transparency, and to minimise bias, were conducted. Eleven studies met the inclusion criteria. Four of these studies included new data published since the PenTAG report; all of these were in chronic-phase CML. No relevant studies on the clinical effectiveness of nilotinib were found. The clinical effectiveness studies on dasatinib [one arm of a randomised controlled trial (RCT)] and high-dose imatinib (one arm of a RCT and three single-arm cohort studies) had major methodological limitations. These limitations precluded a comparison of the different arms within the RCT. Data from the studies are summarised in this report, but caution in interpretation is required. One economic evaluation was identified that compared dasatinib with high-dose imatinib in patients with chronic-phase CML who were CML resistant to standard-dose imatinib. Two industry submissions and the PenTAG economic evaluation were critiqued and differences in the assumptions and results were identified. The PenTAG economic model was adapted and new analyses conducted for the interventions dasatinib, nilotinib and high-dose imatinib and the comparators interferon alfa, standard-dose imatinib, stem cell transplantation and hydroxycarbamide. The results suggest that the three interventions, dasatinib, nilotinib and high-dose imatinib, have similar costs and cost-effectiveness compared with hydroxycarbamide, with a cost-effectiveness of around £30,000 per quality-adjusted life-year gained. However, it is not possible to derive firm conclusions about the relative cost-effectiveness of the three interventions owing to great uncertainty around data inputs. Uncertainty was explored using deterministic sensitivity analyses, threshold analyses and probabilistic sensitivity analyses. The paucity of good-quality evidence should be considered when interpreting this report. This review has identified very limited new information on clinical effectiveness of the interventions over that already shown in the PenTAG report. Limitations in the data exist; however, the results of single-arm studies suggest that the interventions can lead to improvements in haematological and cytogenetic responses in people with imatinib-resistant CML. The economic analyses do not highlight any one of the interventions as being the most cost-effective; however, the analysis results are highly uncertain owing to lack of agreement on appropriate assumptions. Recommendations for future research made by PenTAG, for a good-quality RCT comparing the three treatments remain.

Comparative Effects of Education and Bilingualism on the Onset of Mild Cognitive Impairment.

PubMed

Ramakrishnan, Subasree; Mekala, Shailaja; Mamidipudi, Annapurna; Yareeda, Sireesha; Mridula, Rukmini; Bak, Thomas H; Alladi, Suvarna; Kaul, Subhash

2017-01-01

Increasing evidence suggests that life course factors such as education and bilingualism may have a protective role against dementia due to Alzheimer disease. This study aimed to compare the effects of education and bilingualism on the onset of cognitive decline at the stage of mild cognitive impairment (MCI). A total of 115 patients with MCI evaluated in a specialty memory clinic in Hyderabad, India, formed the cohort. MCI was diagnosed according to Petersen's criteria following clinical evaluation and brain imaging. Age at onset of MCI was compared between bilinguals and monolinguals, and across subjects with high and low levels of education, adjusting for possible confounding variables. The bilingual MCI patients were found to have a clinical onset of cognitive complaints 7.4 years later than monolinguals (65.2 vs. 58.1 years; p = 0.004), while years of education was not associated with delayed onset (1-10 years of education, 59.1 years; 11-15 years of education, 62.6 years; >15 years of education, 62.2 years; p = 0.426). The effect of bilingualism is protective against cognitive decline, and lies along a continuum from normal to pathological states. In comparison, the role of years of education is less robust. © 2017 S. Karger AG, Basel.

A Hypoxia-Targeted Boron Neutron Capture Therapy Agent for the Treatment of Glioma

PubMed Central

Luderer, Micah John; Muz, Barbara; de la Puente, Pilar; Chavalmane, Sanmathi; Kapoor, Vaishali; Marcelo, Raymundo; Biswas, Pratim; Thotala, Dinesh; Rogers, Buck; Azab, Abdel Kareem

2016-01-01

Purpose Boron neutron capture therapy (BNCT) has the potential to become a viable cancer treatment modality, but its clinical translation has been limited by the poor tumor selectivity of agents. To address this unmet need, a boronated 2-nitroimidazole derivative (B-381) was synthesized and evaluated for its capability of targeting hypoxic glioma cells. Methods B-381 has been synthesized from a 1-step reaction. Using D54 and U87 glioma cell lines, the in vitro cytotoxicity and cellular accumulation of B-381 has been evaluated under normoxic and hypoxic conditions compared to L-boronophenylalanine (BPA). Furthermore, tumor retention of B-381 was evaluated in vivo. Results B-381 had low cytotoxicity in normal and cancer cells. Unlike BPA, B-381 illustrated preferential retention in hypoxic glioma cells compared to normoxic glioma cells and normal tissues in vitro. In vivo, B-381 illustrated significantly higher long-term tumor retention compared to BPA, with 9.5-fold and 6.5-fold higher boron levels at 24 and 48 h, respectively. Conclusions B-381 represents a new class of BNCT agents in which their selectivity to tumors is based on tumor hypoxic metabolism, and further studies are warranted to evaluate this compound and similar compounds as preclinical candidates for future BNCT clinical trials for the treatment of glioma. PMID:27401411

The biomedical disciplines and the structure of biomedical and clinical knowledge.

PubMed

Nederbragt, H

2000-11-01

The relation between biomedical knowledge and clinical knowledge is discussed by comparing their respective structures. The knowledge of a disease as a biological phenomenon is constructed by the interaction of facts and theories from the main biomedical disciplines: epidemiology, diagnostics, clinical trial, therapy development and pathogenesis. Although these facts and theories are based on probabilities and extrapolations, the interaction provides a reliable and coherent structure, comparable to a Kuhnian paradigma. In the structure of clinical knowledge, i.e. knowledge of the patient with the disease, not only biomedical knowledge contributes to the structure but also economic and social relations, ethics and personal experience. However, the interaction between each of the participating "knowledges" in clinical knowledge is not based on mutual dependency and accumulation of different arguments from each, as in biomedical knowledge, but on competition and partial exclusion. Therefore, the structure of biomedical knowledge is different from that of clinical knowledge. This difference is used as the basis for a discussion in which the place of technology, evidence-based medicine and the gap between scientific and clinical knowledge are evaluated.

Accuracy and content of medical student midclerkship self-evaluations.

PubMed

Torres, Madeline B; Cochran, Amalia

2016-06-01

Midclerkship self-evaluations (MCSEs) require students to reflect on their knowledge, skills, and behaviors. We hypothesized that MCSEs would be consistent with supervisor midpoint evaluations during a surgical clerkship. MCSEs of 153 students who completed our surgery clerkship in 2 academic years were compared with supervisor midclerkship evaluations. The quantitative domains of the MCSE and supervisor evaluation were compared for accuracy. Identified areas of strengths and weakness were evaluated for thematic consistency. Student MCSE scoring was accurate across evaluated domains most of the time; when students were inaccurate, they tended to underrate themselves. Students and supervisors most often identified cognitive skills as areas for improvement and noncognitive skills predominated as student strengths. Medical students can accurately identify their strengths and weaknesses in the context of an MCSE. Based on these findings, knowledge acquisition and application by medical students in the clinical setting should be emphasized in undergraduate medical education. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical, Functional and Health-Related Quality of Life Correlates of Clinically Significant Symptoms of Anxiety and Depression in Patients with Systemic Sclerosis: A Cross-Sectional Survey

PubMed Central

Nguyen, Christelle; Ranque, Brigitte; Baubet, Thierry; Bérezné, Alice; Mestre-Stanislas, Caroline; Rannou, François; Papelard, Agathe; Morell-Dubois, Sandrine; Revel, Michel; Moro, Marie-Rose; Guillevin, Loïc; Poiraudeau, Serge; Mouthon, Luc

2014-01-01

Objectives To identify clinical, functional and health-related quality of life (HRQoL) correlates of clinically significant symptoms of anxiety and depression in patients with systemic sclerosis (SSc). Methods Three-hundred-and-eighty-one patients fulfilling the American College of Rheumatology and/or the Leroy and Medsger criteria for SSc were assessed for visceral involvement, disability and HRQoL (assessed by SF-36). Clinically significant symptoms of anxiety and depression were evaluated with the Hospital Anxiety Depression Scale (HAD) (defined cut-off≥8). Results 9.2% the patients had limited SSc, 50.5% limited cutaneous SSc (lcSSc), and 40.3% diffuse cutaneous SSc (dcSSc). Overall, 40.4% and 58.8% of the patients had clinically significant symptoms of depression and anxiety, respectively. Compared to patients without clinically significant symptoms of depression, patients with clinically significant symptoms of depression had poorer health status, HRQoL mental and physical component, and greater global disability, hand disability and aesthetic impairment. Compared to patients without clinically significant symptoms of anxiety, patients with clinically significant symptoms of anxiety had poorer SF-36 mental and physical component scores. On multivariable analysis, excluding mental component score of SF-36, variables independently associated with clinically significant symptoms of depression and anxiety were global disability and physical component of SF-36, plus female gender for clinically significant symptoms of anxiety only. Remarkably, patients with and without clinically significant psychiatric symptoms were comparable for all disease-related clinical features assessed. Conclusion High levels of clinically significant symptoms of anxiety and depression are observed among SSc patients. Clinically significant psychiatric symptoms are rather associated with increased disability and altered HRQoL, than with disease-specific organ manifestations. PMID:24587375

Audit method suited for DSS in clinical environment.

PubMed

Vicente, Javier

2015-01-01

This chapter presents a novel online method to audit predictive models using a Bayesian perspective. The auditing model has been specifically designed for Decision Support Systems (DSSs) suited for clinical or research environments. Taking as starting point the working diagnosis supplied by the clinician, this method compares and evaluates the predictive skills of those models able to answer to that diagnosis. The approach consists in calculating the posterior odds of a model through the composition of a prior odds, a static odds, and a dynamic odds. To do so, this method estimates the posterior odds from the cases that the comparing models had in common during the design stage and from the cases already viewed by the DSS after deployment in the clinical site. In addition, if an ontology of the classes is available, this method can audit models answering related questions, which offers a reinforcement to the decisions the user already took and gives orientation on further diagnostic steps.The main technical novelty of this approach lies in the design of an audit model adapted to suit the decision workflow of a clinical environment. The audit model allows deciding what is the classifier that best suits each particular case under evaluation and allows the detection of possible misbehaviours due to population differences or data shifts in the clinical site. We show the efficacy of our method for the problem of brain tumor diagnosis with Magnetic Resonance Spectroscopy (MRS).

A Preliminary Report on the CO2 Laser for Lumbar Fusion: Safety, Efficacy and Technical Considerations.

PubMed

Villavicencio, Alan T; Burneikiene, Sigita; Babuska, Jason M; Nelson, Ewell L; Mason, Alexander; Rajpal, Sharad

2015-04-01

The purpose of this study was to evaluate potential technical advantages of the CO2 laser technology in mini-open transforaminal lumbar interbody fusion (TLIF) surgeries and report our preliminary clinical data on the safety and clinical outcomes. There is currently no literature discussing the recently redeveloped CO2 laser technology application for lumbar fusion. Safety and clinical outcomes were compared between two groups: 24 patients that underwent CO2 laser-assisted one-level TLIF surgeries and 30 patients that underwent standard one-level TLIF surgeries without the laser. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. At a mean follow-up of 17.4 months, significantly reduced lower back pain scores (P=0.013) were reported in the laser-assisted patient group compared to a standard fusion patient group. Lower extremity radicular pain intensity scores were similar in both groups. Laser-assisted TLIF surgeries showed a tendency (P = 0.07) of shorter operative times that was not statistically significant. Based on this preliminary clinical report, the safety of the CO2 laser device for lumbar fusion surgeries was assessed. There were no neural thermal injuries or other intraoperative laser-related complications encountered in this cohort of patients. Further investigation of CO2 laser-assisted lumbar fusion procedures is warranted in order to evaluate its effect on clinical outcomes.

Protocol and baseline data from The Inala Chronic Disease Management Service evaluation study: a health services intervention study for diabetes care.

PubMed

Askew, Deborah A; Jackson, Claire L; Ware, Robert S; Russell, Anthony

2010-05-24

Type 2 Diabetes Mellitus is one of the most disabling chronic conditions worldwide, resulting in significant human, social and economic costs and placing huge demands on health care systems. The Inala Chronic Disease Management Service aims to improve the efficiency and effectiveness of care for patients with type 2 diabetes who have been referred by their general practitioner to a specialist diabetes outpatient clinic. Care is provided by a multidisciplinary, integrated team consisting of an endocrinologist, diabetes nurse educators, General Practitioner Clinical Fellows (general practitioners who have undertaken focussed post-graduate training in complex diabetes care), and allied health personnel (a dietitian, podiatrist and psychologist). Using a geographical control, this evaluation study tests the impact of this model of diabetes care provided by the service on patient outcomes compared to usual care provided at the specialist diabetes outpatient clinic. Data collection at baseline, 6 and 12-months will compare the primary outcome (glycaemic control) and secondary outcomes (serum lipid profile, blood pressure, physical activity, smoking status, quality of life, diabetes self-efficacy and cost-effectiveness). This model of diabetes care combines the patient focus and holistic care valued by the primary care sector with the specialised knowledge and skills of hospital diabetes care. Our study will provide empirical evidence about the clinical effectiveness of this model of care. Australian New Zealand Clinical Trials Registry ACTRN12608000010392.

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.

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

PubMed

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

2017-03-01

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

Evaluating a new paradigm for comparing surface disinfection in clinical practice.

PubMed

Carling, Philip C; Perkins, Jennifer; Ferguson, JoAnn; Thomasser, Anita

2014-11-01

Despite an increasing understanding of the importance of near-patient surfaces in the transmission of healthcare-associated pathogens, there remains a need to define the relative clinical effectiveness of disinfection interventions. A serial 2-phase evaluation of the clinical effectiveness of 2 surface disinfectants. A general acute care hospital. A unique system for quantifying bioburden reduction while monitoring the possible impact of differences in cleaning thoroughness was used to compare the clinical effectiveness of a traditional quaternary ammonium compound (QAC) and a novel peracetic acid/hydrogen peroxide disinfectant (ND) as part of terminal room cleaning. As a result of QAC cleaning, 93 (40%) of 237 cleaned surfaces confirmed by fluorescent marker (DAZO) removal were found to have complete removal of aerobic bioburden. During the ND phase of the study, bioburden was removed from 211 (77%) of 274 cleaned surfaces. Because there was no difference in the thoroughness of cleaning with either disinfectant (65.3% and 66.4%), the significant ([Formula: see text]) difference in bioburden reduction can be attributed to better cleaning efficacy with the ND. In the context of the study design, the ND was 1.93 times more effective in removing bacterial burden than the QAC ([Formula: see text]). Furthermore, the study design represents a new research paradigm in which 2 interventions can be compared by concomitantly and objectively analyzing both the product and process variables in a manner that can be used to define the relative effectiveness of all disinfection cleaning interventions.

Automated brain volumetrics in multiple sclerosis: a step closer to clinical application.

PubMed

Wang, C; Beadnall, H N; Hatton, S N; Bader, G; Tomic, D; Silva, D G; Barnett, M H

2016-07-01

Whole brain volume (WBV) estimates in patients with multiple sclerosis (MS) correlate more robustly with clinical disability than traditional, lesion-based metrics. Numerous algorithms to measure WBV have been developed over the past two decades. We compare Structural Image Evaluation using Normalisation of Atrophy-Cross-sectional (SIENAX) to NeuroQuant and MSmetrix, for assessment of cross-sectional WBV in patients with MS. MRIs from 61 patients with relapsing-remitting MS and 2 patients with clinically isolated syndrome were analysed. WBV measurements were calculated using SIENAX, NeuroQuant and MSmetrix. Statistical agreement between the methods was evaluated using linear regression and Bland-Altman plots. Precision and accuracy of WBV measurement was calculated for (1) NeuroQuant versus SIENAX and (2) MSmetrix versus SIENAX. Precision (Pearson's r) of WBV estimation for NeuroQuant and MSmetrix versus SIENAX was 0.983 and 0.992, respectively. Accuracy (Cb) was 0.871 and 0.994, respectively. NeuroQuant and MSmetrix showed a 5.5% and 1.0% volume difference compared with SIENAX, respectively, that was consistent across low and high values. In the analysed population, NeuroQuant and MSmetrix both quantified cross-sectional WBV with comparable statistical agreement to SIENAX, a well-validated cross-sectional tool that has been used extensively in MS clinical studies. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Nursing students' assessment of the learning environment in different clinical settings.

PubMed

Bisholt, Birgitta; Ohlsson, Ulla; Engström, Agneta Kullén; Johansson, Annelie Sundler; Gustafsson, Margareta

2014-05-01

Nursing students perform their clinical practice in different types of clinical settings. The clinical learning environment is important for students to be able to achieve desired learning outcomes. Knowledge is lacking about the learning environment in different clinical settings. The aim was to compare the learning environment in different clinical settings from the perspective of the nursing students. A cross-sectional study with comparative design was conducted. Data was collected from 185 nursing students at three universities by means of a questionnaire involving the Clinical Learning Environment, Supervision and Nurse Teacher (CLES + T) evaluation scale. An open-ended question was added in order to ascertain reasons for dissatisfaction with the clinical placement. The nursing students' satisfaction with the placement did not differ between clinical settings. However, those with clinical placement in hospital departments agreed more strongly that sufficient meaningful learning situations occurred and that learning situations were multi-dimensional. Some students reported that the character of the clinical setting made it difficult to achieve the learning objectives. In the planning of the clinical placement, attention must be paid to whether the setting offers the student a meaningful learning situation where the appropriate learning outcome may be achieved. Copyright © 2013 Elsevier Ltd. All rights reserved.

Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

PubMed Central

Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

2016-01-01

Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

A comparison of the mechanical properties of fiberglass cast materials and their clinical relevance.

PubMed

Berman, A T; Parks, B G

1990-01-01

The mechanical properties of five synthetic fiberglass casting materials were evaluated and compared with the properties of plaster of Paris. Two of the tests were designed to bear clinical relevance and the third to determine intrinsic material properties. The effect of water on strength degradation was also evaluated. It was found that the synthetics as a group are far superior to plaster of Paris in all methods of testing and that, among the synthetics, KCast Tack Free, Deltalite "S", and KCast Improved were the stronger materials. Clinically, the most important results are that the synthetics attain their relatively high strength in a much shorter time frame than does plaster of Paris, and retain 70-90% of their strength after being immersed in water and allowed to dry.

Integrating fluoroquinolones into the hospital formulary.

PubMed

Bertino, J S

2001-10-01

With the increasing availability of new agents, selection of fluoroquinolones for formulary inclusion can be difficult. Appropriate evaluation of the important characteristics (pharmacokinetic and pharmacodynamic properties, antimicrobial activity, efficacy, tolerability, cost) of these agents should allow selection of the most cost-effective ones. Evidence from in vitro studies and clinical trials indicates differences exist among fluoroquinolones, especially in terms of activity against gram-positive, aerobic organisms. For selected clinical situations, it may be important to choose an agent that is available in both intravenous and oral formulations. Comparative drug costs, as well as costs associated with potential clinical failure and adverse events, should be evaluated carefully. Dosage regimens should be considered, as shorter durations of therapy and less frequent dose administration may lead to reduced labor costs and increased patient compliance, thereby improving effectiveness and economic efficiency.

Health services utilization under Qassam rocket attacks.

PubMed

Goldberg, Lital; Dreiher, Jacob; Friger, Michael; Levin, Alexander; Shvartzman, Pesach

2013-08-01

The Qassam rocket attacks on southern Israel during the years 2000-2007 created a unique situation of life undera continuous threat. The effect of this unique situation on health services utilization has not been previously examined. To evaluate health utilization patterns in two primary care clinics in southern Israel: one under continuous attacks of Qassam rockets as compared with a similar clinic not under a rocket threat. We conducted a retrospective cross-sectional study in two primary care clinics in southern Israel, with 11,630 persons listed in the two clinics during the entire study period. The primary outcome measures were total annual number of visits per person to the clinic and for specific diagnoses, and the number of drug prescriptions issued, emergency room (ER) visits, hospitalization days, cardiac catheterizations and coronary bypass surgeries. In both clinics there was an increase over time in the mean annual number of visits per person. During the years of severe attacks there was an increase in visits with a chief complaint of depression and anxiety and an increase in the number of anxiolytic prescriptions in the study clinic compared with the control. During the same period there was a decrease in the number of ER visits in the study clinic compared with the control. The population under continuous life-threatening events showed more depression and anxiety problems. Under severe bombardment, the residents prefer not to leave home, unless necessary.

Performance evaluation of image denoising developed using convolutional denoising autoencoders in chest radiography

NASA Astrophysics Data System (ADS)

Lee, Donghoon; Choi, Sunghoon; Kim, Hee-Joung

2018-03-01

When processing medical images, image denoising is an important pre-processing step. Various image denoising algorithms have been developed in the past few decades. Recently, image denoising using the deep learning method has shown excellent performance compared to conventional image denoising algorithms. In this study, we introduce an image denoising technique based on a convolutional denoising autoencoder (CDAE) and evaluate clinical applications by comparing existing image denoising algorithms. We train the proposed CDAE model using 3000 chest radiograms training data. To evaluate the performance of the developed CDAE model, we compare it with conventional denoising algorithms including median filter, total variation (TV) minimization, and non-local mean (NLM) algorithms. Furthermore, to verify the clinical effectiveness of the developed denoising model with CDAE, we investigate the performance of the developed denoising algorithm on chest radiograms acquired from real patients. The results demonstrate that the proposed denoising algorithm developed using CDAE achieves a superior noise-reduction effect in chest radiograms compared to TV minimization and NLM algorithms, which are state-of-the-art algorithms for image noise reduction. For example, the peak signal-to-noise ratio and structure similarity index measure of CDAE were at least 10% higher compared to conventional denoising algorithms. In conclusion, the image denoising algorithm developed using CDAE effectively eliminated noise without loss of information on anatomical structures in chest radiograms. It is expected that the proposed denoising algorithm developed using CDAE will be effective for medical images with microscopic anatomical structures, such as terminal bronchioles.

A student-led course in clinical reasoning in the core curriculum

PubMed Central

Zijdenbos, Ingeborg L.; de Haan, Margriet C.; Valk, Gerlof D.

2010-01-01

Objectives There is growing evidence for the value of several forms of peer teaching in medical education. Little is known about the feasibility of such an approach in courses of clinical reasoning. The University Medical Center Utrecht offers a clinical reasoning course for first and second year students which previously had been occasionally led by sixth year, i.e. near-peer students. We evaluated a version of this course, fully delivered by final year students. Methods In 2008-2009 this highly structured mandatory clinical reasoning course for second year medical students was fully tutored by final year medical students, as part of a teacher training course in their core curriculum. Routine evaluations before and after introducing near-peers as tutors were compared, a focused questionnaire survey was conducted, as well as an interview with a group of students to evaluate the new format. Results There was no difference in the ratings of the course before and after the introduction of the new format. In general, second year students are satisfied with the near-peer teachers. Strong points mentioned are their high motivation, involvement, enthusiasm, adjustment of cognitive level of teaching to the recipient students and stimulating skills. Conclusions Although our study cannot provide evidence for differential learning effects, the evaluation of our final year student led clinical reasoning course shows encouraging results.

A Prospective, Randomized, Masked, Placebo-Controlled Multisite Clinical Study of Grapiprant, an EP4 Prostaglandin Receptor Antagonist (PRA), in Dogs with Osteoarthritis.

PubMed

Rausch-Derra, L; Huebner, M; Wofford, J; Rhodes, L

2016-05-01

This study evaluated the effectiveness and safety of grapiprant for treatment of pain in dogs with osteoarthritis (OA). Grapiprant will relieve pain as measured by the owner's and veterinarian's evaluation of pain in dogs with OA. Another objective was evaluation of the safety of grapiprant. Two hundred and eighty-five client-owned dogs with OA were enrolled and treated with grapiprant or placebo with 262 cases (N = 131 in each group) evaluable for the effectiveness analysis. In this prospective, randomized, masked, placebo-controlled study dogs were treated daily with grapiprant (2 mg/kg) per OS or placebo. Owners completed an evaluation using the Canine Brief Pain Inventory (CBPI) on days 0, 7, 14, 21, and 28. Success was defined as improvement in the CBPI. Veterinary assessments were made on screening and days 14 and 28. Safety was evaluated by physical examination, evaluation of clinical pathology results, and owner observations. Grapiprant treatment improved pain compared to placebo on day 28 (48.1 and 31.3% treatment successes respectively; P = .0315). The pain interference score (PIS) and pain severity score (PSS) improved in the grapiprant group compared to placebo (P = .0029 and 0.0022, respectively). Veterinary assessments were significantly better in the grapiprant-treated dogs (P = .0086). Grapiprant generally was well tolerated, but a higher percentage of treated dogs (17.02%) had occasional vomiting as compared to the placebo group (6.25%). Grapiprant is an effective treatment for alleviation of pain in dogs with OA, and represents a modality of treatment that may be better tolerated than current options. Copyright © 2016 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Evaluating treatment process redesign by applying the EFQM Excellence Model.

PubMed

Nabitz, Udo; Schramade, Mark; Schippers, Gerard

2006-10-01

To evaluate a treatment process redesign programme implementing evidence-based treatment as part of a total quality management in a Dutch addiction treatment centre. Quality management was monitored over a period of more than 10 years in an addiction treatment centre with 550 professionals. Changes are evaluated, comparing the scores on the nine criteria of the European Foundation for Quality Management (EFQM) Excellence Model before and after a major redesign of treatment processes and ISO certification. In the course of 10 years, most intake, care, and cure processes were reorganized, the support processes were restructured and ISO certified, 29 evidence-based treatment protocols were developed and implemented, and patient follow-up measuring was established to make clinical outcomes transparent. Comparing the situation before and after the changes shows that the client satisfaction scores are stable, that the evaluation by personnel and society is inconsistent, and that clinical, production, and financial outcomes are positive. The overall EFQM assessment by external assessors in 2004 shows much higher scores on the nine criteria than the assessment in 1994. Evidence-based treatment can successfully be implemented in addiction treatment centres through treatment process redesign as part of a total quality management strategy, but not all results are positive.

A matched-pair comparison of inlay and onlay trochlear designs for patellofemoral arthroplasty: no differences in clinical outcome but less progression of osteoarthritis with inlay designs.

PubMed

Feucht, Matthias J; Cotic, Matthias; Beitzel, Knut; Baldini, Julia F; Meidinger, Gebhart; Schöttle, Philip B; Imhoff, Andreas B

2017-09-01

To compare clinical and radiographic results after isolated patellofemoral arthroplasty (PFA) using either a second-generation inlay or onlay trochlear design. The hypothesis was that an inlay design will produce better clinical results and less progression of tibiofemoral osteoarthritis (OA) compared to an onlay design. Fifteen consecutive patients undergoing isolated PFA with an onlay design trochlear component (Journey™ PFJ, Smith & Nephew) were matched with 15 patients after isolated PFA with an inlay design trochlear component (HemiCAP ® Wave, Arthrosurface). Matching criteria were age, gender, body mass index, and follow-up period. An independent observer evaluated patients prospectively, whereas data were compared retrospectively. Clinical outcome was assessed using WOMAC, Lysholm score, and pain VAS. Kellgren-Lawrence grading was used to assess progression of tibiofemoral OA. Conversion to total knee arthroplasty was necessary in one patient within each group, leaving 14 patients per group for final evaluation. The mean follow-up was 26 months in the inlay group and 25 months in the onlay group (n.s.). Both groups displayed significant improvements of all clinical scores (p < 0.05). No significant differences were found between the two groups with regard to the clinical outcome and reoperation rate. No significant progression of tibiofemoral OA was observed in the inlay group, whereas 53 % of the onlay group showed progression of medial and/or lateral tibiofemoral OA (p = 0.009). Isolated PFA using either a second-generation inlay or onlay trochlear component significantly improves functional outcome scores and pain. The theoretical advantages of an inlay design did not result in better clinical outcome scores; however, progression of tibiofemoral OA was significantly less common in patients with an inlay trochlear component. This implant design may therefore improve long-term results and survival rates after isolated PFA. III.