A novel clinical evaluation method using maximum angular velocity during knee extension to assess lower extremity muscle function of older adults.

PubMed

Arai, Takeshi; Obuchi, Shuichi; Shiba, Yoshitaka

2017-11-01

The purpose of this study is to examine the utilities of maximum angular velocity (AV) assessment during knee extension (KE) using a gyroscope for clinical evaluation of exercise program for older adults. Two hundred and 4 community-dwelling older adults underwent a 3-month exercise intervention program. Outcome measures included AV during KE and other physical functions (isometric strength (IS), walking abilities, and balance functions). A correlation coefficient was used to evaluate the relationships between AV and other physical functions at baseline. The differences of physical functions before and after intervention were evaluated and the effect size of each measurement was calculated after the program. The AV measurement was significantly correlated with IS during KE (r=0.303, P<0.01) and other physical functions. Most correlation coefficients of angular velocity were greater than that of IS. All of physical assessments were significantly improved. Also, effect size of AV was greater than that of IS (d=0.45 vs. 0.42). AV of the lower extremities is useful to evaluate the effects of exercise intervention in the elderly. Copyright © 2017 Elsevier B.V. All rights reserved.

Models for the study of Clostridium difficile infection

PubMed Central

Best, Emma L.; Freeman, Jane; Wilcox, Mark H.

2012-01-01

Models of Clostridium difficile infection (C. difficile) have been used extensively for Clostridium difficile (C. difficile) research. The hamster model of C. difficile infection has been most extensively employed for the study of C. difficile and this has been used in many different areas of research, including the induction of C. difficile, the testing of new treatments, population dynamics and characterization of virulence. Investigations using in vitro models for C. difficile introduced the concept of colonization resistance, evaluated the role of antibiotics in C. difficile development, explored population dynamics and have been useful in the evaluation of C. difficile treatments. Experiments using models have major advantages over clinical studies and have been indispensible in furthering C. difficile research. It is important for future study programs to carefully consider the approach to use and therefore be better placed to inform the design and interpretation of clinical studies. PMID:22555466

The clinical significance of isolated loss of lordosis on cervical spine computed tomography in blunt trauma patients: a prospective evaluation of 1,007 patients.

PubMed

Mejaddam, Ali Y; Kaafarani, Haytham M A; Ramly, Elie P; Avery, Laura L; Yeh, Dante D; King, David R; de Moya, Marc A; Velmahos, George C

2015-11-01

A negative computed tomographic (CT) scan may be used to rule out cervical spine (c-spine) injury after trauma. Loss of lordosis (LOL) is frequently found as the only CT abnormality. We investigated whether LOL should preclude c-spine clearance. All adult trauma patients with isolated LOL at our Level I trauma center (February 1, 2011 to May 31, 2012) were prospectively evaluated. The primary outcome was clinically significant injury on magnetic resonance imaging (MRI), flexion-extension views, and/or repeat physical examination. Of 3,333 patients (40 ± 17 years, 60% men) with a c-spine CT, 1,007 (30%) had isolated LOL. Among 841 patients with a Glasgow Coma Scale score of 15, no abnormalities were found on MRI, flexion-extension views, and/or repeat examinations, and all collars were removed. Among 166 patients with Glasgow Coma Scale less than 15, 3 (.3%) had minor abnormal MRI findings but no clinically significant injury. Isolated LOL on c-spine CT is not associated with a clinically significant injury and should not preclude c-spine clearance. Copyright © 2015 Elsevier Inc. All rights reserved.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

PubMed

Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

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

Clinical relevance vs. statistical significance: Using neck outcomes in patients with temporomandibular disorders as an example.

PubMed

Armijo-Olivo, Susan; Warren, Sharon; Fuentes, Jorge; Magee, David J

2011-12-01

Statistical significance has been used extensively to evaluate the results of research studies. Nevertheless, it offers only limited information to clinicians. The assessment of clinical relevance can facilitate the interpretation of the research results into clinical practice. The objective of this study was to explore different methods to evaluate the clinical relevance of the results using a cross-sectional study as an example comparing different neck outcomes between subjects with temporomandibular disorders and healthy controls. Subjects were compared for head and cervical posture, maximal cervical muscle strength, endurance of the cervical flexor and extensor muscles, and electromyographic activity of the cervical flexor muscles during the CranioCervical Flexion Test (CCFT). The evaluation of clinical relevance of the results was performed based on the effect size (ES), minimal important difference (MID), and clinical judgement. The results of this study show that it is possible to have statistical significance without having clinical relevance, to have both statistical significance and clinical relevance, to have clinical relevance without having statistical significance, or to have neither statistical significance nor clinical relevance. The evaluation of clinical relevance in clinical research is crucial to simplify the transfer of knowledge from research into practice. Clinical researchers should present the clinical relevance of their results. Copyright © 2011 Elsevier Ltd. All rights reserved.

Clinical Management of HIV Drug Resistance

PubMed Central

Cortez, Karoll J.; Maldarelli, Frank

2011-01-01

Combination antiretroviral therapy for HIV-1 infection has resulted in profound reductions in viremia and is associated with marked improvements in morbidity and mortality. Therapy is not curative, however, and prolonged therapy is complicated by drug toxicity and the emergence of drug resistance. Management of clinical drug resistance requires in depth evaluation, and includes extensive history, physical examination and laboratory studies. Appropriate use of resistance testing provides valuable information useful in constructing regimens for treatment-experienced individuals with viremia during therapy. This review outlines the emergence of drug resistance in vivo, and describes clinical evaluation and therapeutic options of the individual with rebound viremia during therapy. PMID:21994737

Clinical Outcomes following median to radial nerve transfers

PubMed Central

Ray, Wilson Z.; Mackinnon, Susan E.

2010-01-01

Purpose In this study the authors evaluate the clinical outcomes in patients with radial nerve palsy who underwent nerve transfers utilizing redundant fascicles of median nerve (innervating the flexor digitorum superficialis and flexor carpi radialis muscles) to the posterior interosseous nerve and the nerve to the extensor carpi radialis brevis. Methods A retrospective review of the clinical records of 19 patients with radial nerve injuries who underwent nerve transfer procedures using the median nerve as a donor nerve were included. All patients were evaluated using the Medical Research Council (MRC) grading system. Results The mean age of patients was 41 years (range 17 – 78 years). All patients received at least 12 months of follow-up (20.3 ± 5.8 months). Surgery was performed at a mean of 5.7 ± 1.9 months post-injury. Post-operative functional evaluation was graded according to the following scale: grades MRC 0/5 - MRC 2/5 were considered poor outcomes, while MRC of 3/5 was a fair result, MRC grade 4/5 was a good result, and grade 4+/5 was considered an excellent outcome. Seventeen patients (89%) had a complete radial nerve palsy while two patients (11%) had intact wrist extension but no finger or thumb extension. Post-operatively all patients except one had good to excellent recovery of wrist extension. Twelve patients recovered good to excellent finger and thumb extension, two patients had fair recovery, five patients had a poor recovery. Conclusions The radial nerve is a commonly injured nerve, causing significant morbidity in affected patients. The median nerve provides a reliable source of donor nerve fascicles for radial nerve reinnervation. This transfer was first performed in 1999 and evolved over the subsequent decade. The important nuances of both surgical technique and motor re-education critical for to the success of this transfer have been identified and are discussed. PMID:21168979

Evaluation of the effect of different stretching patterns on force decay and tensile properties of elastomeric ligatures

PubMed Central

Aminian, Amin; Nakhaei, Samaneh; Agahi, Raha Habib; Rezaeizade, Masoud; Aliabadi, Hamed Mirzazadeh; Heidarpour, Majid

2015-01-01

Background: There have been numerous researches on elastomeric ligatures, but clinical conditions in different stages of treatment are not exactly similar to laboratory conditions. The aim of this in vitro study was to simulate clinical conditions and evaluate the effect of three stretching patterns on the amount of force, tensile strength (TS) and extension to TS of the elastomers during 8 weeks. Materials and Methods: Forces, TS and extension to TS of two different brands of elastomers were measured at initial, 24 h and 2, 4, and 8-week intervals using a testing machine. During the study period, the elastomers were stored in three different types of jig (uniform stretching, 1 and 3 mm point stretching) designed by the computer-aided design and computer-aided manufacturing technique in order to simulate the different stages of orthodontic treatment. Results: The elastomeric ligatures under study exhibited a similar force decay pattern. The maximum force decay occurred during the first 24 h (49.9% ± 15%) and the amount of force decay was 75.7% ± 8% after 8 weeks. In general, the TS decreased during the study period, and the amount of extension to TS increased. Conclusion: Although the elastic behavior of all ligatures under study was similar, the amount of residual force, TS and extension to TS increased in elastomers under point stretching pattern. PMID:26759597

Evaluation of the effect of different stretching patterns on force decay and tensile properties of elastomeric ligatures.

PubMed

Aminian, Amin; Nakhaei, Samaneh; Agahi, Raha Habib; Rezaeizade, Masoud; Aliabadi, Hamed Mirzazadeh; Heidarpour, Majid

2015-01-01

There have been numerous researches on elastomeric ligatures, but clinical conditions in different stages of treatment are not exactly similar to laboratory conditions. The aim of this in vitro study was to simulate clinical conditions and evaluate the effect of three stretching patterns on the amount of force, tensile strength (TS) and extension to TS of the elastomers during 8 weeks. Forces, TS and extension to TS of two different brands of elastomers were measured at initial, 24 h and 2, 4, and 8-week intervals using a testing machine. During the study period, the elastomers were stored in three different types of jig (uniform stretching, 1 and 3 mm point stretching) designed by the computer-aided design and computer-aided manufacturing technique in order to simulate the different stages of orthodontic treatment. The elastomeric ligatures under study exhibited a similar force decay pattern. The maximum force decay occurred during the first 24 h (49.9% ± 15%) and the amount of force decay was 75.7% ± 8% after 8 weeks. In general, the TS decreased during the study period, and the amount of extension to TS increased. Although the elastic behavior of all ligatures under study was similar, the amount of residual force, TS and extension to TS increased in elastomers under point stretching pattern.

Determination of spondylolisthesis in low back pain by clinical evaluation.

PubMed

Kalpakcioglu, Banu; Altinbilek, Turgay; Senel, Kazim

2009-01-01

Current guides recommend to evaluate the patients with low back pain complaints with initial clinical assessment and history, and to utilize radiological or other imaging technics, in case of possible diagnosis. The aim of this study was to compare the findings of radiological and clinical assessment, and validate the reliability of spondylolisthesis diagnosed with clinical assessment. This study is conducted on 100 patients with, and 30 patients without (control group) radiological diagnosis of spondylolisthesis, who had applied to Department of Physical Therapy and Rehabilitation, Haydarpasa Numune Hospital with low back pain complaints in one and a half year. Clinic assessment was consisted of 20 parameters including examinations of motor system such as, sign of slipping observed on palpation and inspection, extension of trunk and increase in lumbar lordosis. Antero-posterior, lateral, oblique and lateral flexion/extension radiographies were used for radiological assessment. Slipping degree and lumbar lordosis angle were measured. Women/men patients ratio was 91/9 in spondylolisthesis group and 22/8 in control group. Age of 69% of patients were 50 and over. In both groups, sciatalgia was observed in more than half of the patients, and no significant difference was detected in localization (p > 0.05). In clinical assessment, weak and drooping abdominal wall, paravertebral muscle hypertrophy, increase in lumbar lordosis, sign of slipping observed on palpation and inspection, hamstring muscle spasm, pain during lateral trunk flexion-extension tasks and during double leg raising task were found to be positively correlated with radiological assesment (p < 0.05). In our study, a systematic clinical assessment was proved to be useful in determination of possible spondylolisthesis cases. Radiological assessments are required in order to make the diagnosis clear and to determine the grade and prognosis of spondylolisthesis. Advanced imaging techniques like MRI and CT have to be used when neurological symptoms are present, and when surgical intervention is indicated.

Long-term efficacy and safety of lamotrigine monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures: An open-label extension study.

PubMed

Yasumoto, Sawa; Ohtsuka, Yoko; Sato, Katsuaki; Kurata, Atsuyo; Numachi, Yotaro; Shimizu, Masahiro

2018-05-31

To investigate the efficacy and safety of long-term lamotrigine (LTG) monotherapy in Japanese and South Korean pediatric patients with newly diagnosed typical absence seizures. Six Japanese patients and one South Korean patient were enrolled in the extension phase of the study after completing the 12-week maintenance phase of an open-label clinical study of LTG monotherapy. During the extension phase, patients underwent efficacy and safety evaluation every 12 weeks. Of the seven patients, six patients completed the extension phase. The seizure-free rate confirmed by hyperventilation (HV)-electroencephalography ranged from 71.4% to 100.0% at each visit up to Week 168 of the extension phase. Similar effects were confirmed by HV-clinical signs and seizure diaries. Although no unexpected adverse events were observed, one Japanese patient was withdrawn from the extension phase due to mild drug-related rash developed 842 days after the start of LTG. Although the number of patients is limited, long-term LTG monotherapy appeared to be effective and generally well tolerated in Japanese and South Korean pediatric patients with typical absence seizures. Copyright © 2018 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Outcome Measures for Clinical Trials in Down Syndrome

PubMed Central

Esbensen, Anna J.; Hooper, Stephen R.; Fidler, Deborah; Hartley, Sigan; Edgin, Jamie; d’Ardhuy, Xavier Liogier; Capone, George; Conners, Frances; Mervis, Carolyn B.; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J.; Urv, Tiina

2017-01-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the NIH assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This paper focuses on measures in the areas of cognition and behavior. PMID:28452584

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.

The Clinical Evaluation of Hypertension

PubMed Central

de Champlain, Jacques

1985-01-01

The incidence of secondary hypertension in clinical practice is probably below 5%. The majority of those cases are of renal origin. Extensive and costly investigations for rarer forms of hypertension therefore do not appear justified. A comprehensive medical history, plus a good physical exam and some critical laboratory analyses can uncover the great majority of primary and secondary forms of hypertension, allowing for the detection of additional risks factors. Current research trends will eventually provide newer approaches which may permit a better evaluation of the prognosis of hypertension, as well as the development of more efficient therapies. Imagesp307-a PMID:21274102

Evaluation of long term health-related quality of life in extensive burns: a 12-year experience in a burn center.

PubMed

Xie, Bing; Xiao, Shi-chu; Zhu, Shi-hui; Xia, Zhao-fan

2012-05-01

We sought to evaluate the long term health-related quality of life (HRQOL) in patients survived severely extensive burn and identify their clinical predicting factors correlated with HRQOL. A cross-sectional study was conducted in 20 patients survived more than 2 years with extensive burn involving ≥70% total body surface area (TBSA) between 1997 and 2009 in a burn center in Shanghai. Short Form-36 Medical Outcomes Survey (SF-36), Brief Version of Burn Specific Health Scale (BSHS-B) and Michigan Hand Outcome Questionnaire (MHQ) were used for the present evaluation. SF-36 scores were compared with a healthy Chinese population, and linear correlation analysis was performed to screen the clinical relating factors predicting physical and mental component summary (PCS and MCS) scores from SF-36. HRQOL scores from SF-36 were significantly lower in the domains of physical functioning, role limitations due to physical problems, pain, social functioning and role limitations due to emotional problems compared with population norms. Multiple linear regression analysis demonstrated that only return to work (RTW) predicted improved PCS. While age at injury, facial burns, skin grafting and length of hospital stay were correlated with MCS. Work, body image and heat sensitivity obtained the lowest BSHS-B scores in all 9 domains. Improvements of HRQOL could still be seen in BSHS-B scores in domains of simple abilities, hand function, work and affect even after a quite long interval between burns and testing. Hand function of extensive burn patients obtained relatively poor MHQ scores, especially in those without RTW. Patients with extensive burns have a poorer quality of life compared with that of general population. Relatively poor physical and psychological problems still exist even after a long period. Meanwhile, a trend of gradual improvements was noted. This information will aid clinicians in decision-making of comprehensive systematic regimens for long term rehabilitation and psychosocial treatment. Copyright © 2011 Elsevier Ltd and ISBI. All rights reserved.

Use of clinical and computed tomography findings to assess long-term unsatisfactory outcome after femoral head and neck ostectomy in four large breed dogs.

PubMed

Ober, Ciprian; Pestean, Cosmin; Bel, Lucia; Taulescu, Marian; Milgram, Joshua; Todor, Adrian; Ungur, Rodica; Leșu, Mirela; Oana, Liviu

2018-05-10

Femoral head and neck ostectomy (FHNO) is a salvage surgical procedure intended to eliminate hip joint laxity associated pain in the immature dog, or pain due to secondary osteoarthritis in the mature dog. The outcome of the procedure is associated with the size of the dog but the cause of a generally poorer outcome in larger breeds has not been determined. The objective of this study was to assess the long-term results of FHNO associated with unsatisfactory functional outcome by means of clinical examination and computed tomography (CT) scanning. Four large mixed breed dogs underwent FHNO in different veterinary clinics. Clinical and CT scanning evaluations were carried out long time after the procedures had been done. Hip pain, muscle atrophy, decreased range of motion and chronic lameness were observed at clinical examination. Extensive remodelling, unacceptable bone-on-bone contact with bony proliferation involving the femoral neck and acetabulum, but also excessive removal with bone lysis were observed by CT scanning. Revision osteotomy was performed in one dog. Deep gluteal muscle interposition was used, but no improvements were observed postoperatively. This is the first report on the evaluation of three-dimensional CT reconstructions of the late bone remodelling associated with poor clinical outcome in large dogs. The study shows that FHNO could lead to severe functional deficits in large breed dogs. An extensive follow-study is necessary to more accurately determine the frequency of such complications.

Risk factors and clinical features of text message injuries.

PubMed

Sharan, Deepak; Ajeesh, P S

2012-01-01

Use of mobile phone and sending text message is a very common in today's life. While sending a text message the users need to use their thumb and other palm muscles extensively. The thumb most of the time adducted on the key pad of the mobile and use high force to type the letters. Studies in literature showed that text messaging has an adverse effect on musculoskeletal system of hand. But the extensive study on the type of disorders set in among the users who extensively use mobile phone for texting. This study aims at to evaluate risk factor and clinical feature of the MSD due to hand held devices. Twenty seven subjects participated in this study. Predefined protocols were used to evaluate type of MSD occurred among the subjects. The study revealed that development of tendinitis in extensor pollicis longus, myofascial pain syndrome (70.37%) of adductor pollicis, 1st interossei and extensor digitorum communis . Other associated problems diagnosed were thoracic outlet syndrome (51.85%), fibromyalgia syndrome (25.93%), hypothyroidism (7.41%), wrist tendinitis (14.81%) and De Quervain's syndrome (7.41%). It has been observed that the pathology were tendinitis of extensor pollicis longus, myofascial pain syndrome of thenar muscles and 1st interossei, extensor digitorum communis.

Efficacy of Vismodegib (Erivedge) for Basal Cell Carcinoma Involving the Orbit and Periocular Area.

PubMed

Demirci, Hakan; Worden, Francis; Nelson, Christine C; Elner, Victor M; Kahana, Alon

2015-01-01

Evaluate the effectiveness of vismodegib in the management of basal cell carcinoma with orbital extension and/or extensive periocular involvement. Retrospective chart review of 6 consecutive patients with biopsy-proven orbital basal cell carcinoma and 2 additional patients with extensive periocular basal cell carcinoma who were treated with oral vismodegib (150 mg/day) was performed. Basal cell carcinoma extended in the orbit in 6 of 8 patients (involving orbital bones in 1 patient), and 2 of 8 patients had extensive periocular involvement (1 with basal cell nevus syndrome). Vismodegib therapy was the only treatment in 6 patients, off-label neoadjuvant in 1 patient, and adjuvant treatment in 1 patient. Orbital tumors in all 4 patients who received vismodegib as sole treatment showed partial response with a mean 83% shrinkage in tumor size after a median of 7 months of therapy. In the 2 patients receiving vismodegib as neoadjuvant or adjuvant therapies, there was complete response after a median of 7 months of therapy and no evidence of clinical recurrence after discontinuing therapy for a median of 15 months. The 2 patients with extensive periocular involvement experienced complete clinical response after a median 14 months of treatment. During treatment, the most common side effects were muscle spasm (75%) followed by alopecia (50%), dysgeusia (25%), dysosmia, and episodes of diarrhea and constipation (13%). Basal cell carcinoma with orbital extension and extensive periocular involvement responds to vismodegib therapy. The long-term prognosis remains unknown, and additional prospective studies are indicated.

Clinical outcomes of proximal row carpectomy versus four-corner arthrodesis for post-traumatic wrist arthropathy: a systematic review.

PubMed

Saltzman, B M; Frank, J M; Slikker, W; Fernandez, J J; Cohen, M S; Wysocki, R W

2015-06-01

We conducted a systematic review of studies reporting clinical outcomes after proximal row carpectomy or to four-corner arthrodesis for scaphoid non-union advanced collapse or scapholunate advanced collapse arthritis. Seven studies (Levels I-III; 240 patients, 242 wrists) were evaluated. Significantly different post-operative values were as follows for four-corner arthrodesis versus proximal row carpectomy groups: wrist extension, 39 (SD 11º) versus 43 (SD 11º); wrist flexion, 32 (SD 10º) versus 36 (SD 11º); flexion-extension arc, 62 (SD 14º) versus 75 (SD 10º); radial deviation, 14 (SD 5º) versus 10 (SD 5º); hand grip strength as a percentage of contralateral side, 74% (SD 13) versus 67% (SD 16); overall complication rate, 29% versus 14%. The most common post-operative complications were non-union (grouped incidence, 7%) after four-corner arthrodesis and synovitis and clinically significant oedema (3.1%) after proximal row carpectomy. Radial deviation and post-operative hand grip strength (as a percentage of the contralateral side) were significantly better after four-corner arthrodesis. Four-corner arthrodesis gave significantly greater post-operative radial deviation and grip strength as a percentage of the opposite side. Wrist flexion, extension, and the flexion-extension arc were better after proximal row carpectomy, which also had a lower overall complication rate. © The Author(s) 2014.

Technical and clinical description of a case of extensive anogenital Paget's disease associated with anal cancer treated by tomotherapy.

PubMed

Garibaldi, Elisabetta; Cattari, Gabriella; Delmastro, Elena; Siatis, Dimitrios; Racca, Manuela; Maggio, Angelo; Gabriele, Domenico; Frangipane, Elena; Gabriele, Pietro

2014-01-01

In this paper we describe a case of extramammary Paget's disease associated with anal cancer, which was successfully treated by intensity-modulated radiotherapy using tomotherapy with a simultaneous integrated boost and daily image guidance. The main pitfall in this report is the relatively short follow-up (1 year), which means that the evaluated data is promising but not conclusive. Considering the rarity and wide extension of our patient's Paget's disease in the anogenital region, and the lack of literature reports about curative radiotherapy in this particular setting, this case report may be considered the first related to extensive extramammary Paget's disease treated by tomotherapy.

Outcome Measures for Clinical Trials in Down Syndrome.

PubMed

Esbensen, Anna J; Hooper, Stephen R; Fidler, Deborah; Hartley, Sigan L; Edgin, Jamie; d'Ardhuy, Xavier Liogier; Capone, George; Conners, Frances A; Mervis, Carolyn B; Abbeduto, Leonard; Rafii, Michael; Krinsky-McHale, Sharon J; Urv, Tiina

2017-05-01

Increasingly individuals with intellectual and developmental disabilities, including Down syndrome, are being targeted for clinical trials. However, a challenge exists in effectively evaluating the outcomes of these new pharmacological interventions. Few empirically evaluated, psychometrically sound outcome measures appropriate for use in clinical trials with individuals with Down syndrome have been identified. To address this challenge, the National Institutes of Health (NIH) assembled leading clinicians and scientists to review existing measures and identify those that currently are appropriate for trials; those that may be appropriate after expansion of age range addition of easier items, and/or downward extension of psychometric norms; and areas where new measures need to be developed. This article focuses on measures in the areas of cognition and behavior.

The value of item response theory in clinical assessment: a review.

PubMed

Thomas, Michael L

2011-09-01

Item response theory (IRT) and related latent variable models represent modern psychometric theory, the successor to classical test theory in psychological assessment. Although IRT has become prevalent in the measurement of ability and achievement, its contributions to clinical domains have been less extensive. Applications of IRT to clinical assessment are reviewed to appraise its current and potential value. Benefits of IRT include comprehensive analyses and reduction of measurement error, creation of computer adaptive tests, meaningful scaling of latent variables, objective calibration and equating, evaluation of test and item bias, greater accuracy in the assessment of change due to therapeutic intervention, and evaluation of model and person fit. The theory may soon reinvent the manner in which tests are selected, developed, and scored. Although challenges remain to the widespread implementation of IRT, its application to clinical assessment holds great promise. Recommendations for research, test development, and clinical practice are provided.

Kinematics of the thoracic T10-T11 motion segment: locus of instantaneous axes of rotation in flexion and extension.

PubMed

Qiu, Tian-Xia; Teo, Ee-Chon; Lee, Kim-Kheng; Ng, Hong-Wan; Yang, Kai

2004-04-01

The purpose of this study was to determine the locations and loci of instantaneous axes of rotation (IARs) of the T10-T11 motion segment in flexion and extension. An anatomically accurate three-dimensional model of thoracic T10-T11 functional spinal unit (FSU) was developed and validated against published experimental data under flexion, extension, lateral bending, and axial rotation loading configurations. The validated model was exercised under six load configurations that produced motions only in the sagittal plane to characterize the loci of IARs for flexion and extension. The IARs for both flexion and extension under these six load types were directly below the geometric center of the moving vertebra, and all the loci of IARs were tracked superoanteriorly for flexion and inferoposteriorly for extension with rotation. These findings may offer an insight to better understanding of the kinematics of the human thoracic spine and provide clinically relevant information for the evaluation of spinal stability and implant device functionality.

Electrochemotherapy efficacy evaluation for treatment of locally advanced stage III cutaneous squamous cell carcinoma: a 22-cases retrospective analysis.

PubMed

Di Monta, Gianluca; Caracò, Corrado; Simeone, Ester; Grimaldi, Antonio Maria; Marone, Ugo; Di Marzo, Massimiliano; Vanella, Vito; Festino, Lucia; Palla, Marco; Mori, Stefano; Mozzillo, Nicola; Ascierto, Paolo Antonio

2017-04-26

Extensive squamous cell carcinoma has few therapeutic options. In such cases, electrochemotherapy involving electroporation combined with antineoplastic drug appears to be a new potential option and may be considered as an alternative treatment. The aim of this retrospective single-center study was to evaluate electrochemotherapy efficacy in treatment of locally advanced stage III squamous cell carcinoma, in which surgical procedures would have entailed wide tissue sacrifice. Clinical features, treatment response, and adverse effects were evaluated in 22 patients treated with electrochemotherapy with intravenous injection of bleomycin for extensive stage III cutaneous squamous cell carcinoma. Treatment of cutaneous lesions were performed according to the European Standard Operating Procedures of Electrochemotherapy. Overall response to electrochemotherapy treatment was observed in 18 (81.8%) patients. Clinical response with necrosis of tumor mass was observed from the first session and lasted for all follow up period that ranged between 5 and 48 months with a median of 34 months. Overall the treatment was well tolerated with a very low complication rate. Electrochemotherapy represents a safe and effective therapeutic approach, associated with a good tolerability.

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

PubMed

Renisch, B; Lauer, W

2014-12-01

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

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.

Boomerang sign on MRI.

PubMed

Hirsch, Karen G; Hoesch, Robert E

2012-06-01

Altered mental status and more subtle cognitive and personality changes after traumatic brain injury (TBI) are pervasive problems in patients who survive initial injury. MRI is not necessarily part of the diagnostic evaluation of these patients. Case report with relevant image and review of the literature. Injury to the corpus callosum is commonly described in traumatic brain injury; however, extensive lesions in the splenium are not well described. This image shows an important pattern of brain injury and demonstrates a common clinical syndrome seen in patients with corpus callosum pathology. Injury to the splenium of the corpus callosum due to trauma may be extensive and can cause significant neurologic deficits. MRI is important in the diagnostic evaluation of patients with cognitive changes after TBI.

High In Vitro Activity of the Novel Spiropyrimidinetrione AZD0914, a DNA Gyrase Inhibitor, against Multidrug-Resistant Neisseria gonorrhoeae Isolates Suggests a New Effective Option for Oral Treatment of Gonorrhea

PubMed Central

Jacobsson, Susanne; Golparian, Daniel; Alm, Richard A.; Huband, Michael; Mueller, John; Jensen, Jorgen Skov; Ohnishi, Makoto

2014-01-01

We evaluated the activity of the novel spiropyrimidinetrione AZD0914 (DNA gyrase inhibitor) against clinical gonococcal isolates and international reference strains (n = 250), including strains with diverse multidrug resistance and extensive drug resistance. The AZD0914 MICs were substantially lower than those of most other currently or previously recommended antimicrobials. AZD0914 should be further evaluated, including in vitro selection, in vivo emergence and mechanisms of resistance, pharmacokinetics/pharmacodynamics in humans, optimal dosing, and performance, in appropriate randomized and controlled clinical trials. PMID:24982070

The trigeminal trophic syndrome: an unusual cause of nasal ulceration.

PubMed

Monrad, Seetha U; Terrell, Jeffrey E; Aronoff, David M

2004-06-01

Trigeminal trophic syndrome (TTS) is an unusual complication after peripheral or central damage to the trigeminal nerve, characterized by anesthesia, paresthesias, and ala nasi ulceration. We describe a patient with classic TTS after trigeminal rhizotomy who underwent several extensive evaluations for nasal ulceration and received prolonged immunosuppressive therapy for a presumed autoimmune disorder before the correct diagnosis was made. An understanding of the predisposing factors and clinical presentation of TTS is important to ensure a timely diagnosis of this difficult-to-treat illness. Differentiation of TTS from malignancy, infection, or vasculitis is possible on the basis of clinical history, tissue biopsy, and serologic evaluation.

A non-pregnant woman with elevated beta-HCG: A case of para-neoplastic syndrome in ovarian cancer.

PubMed

Goldstein, Jennifer; Pandey, Prasamsa; Fleming, Nicole; Westin, Shannon; Piha-Paul, Sarina

2016-08-01

There is a broad range of possible diagnoses for an elevated beta human chorionic gonadotropin (β-hCG) in the absence of intrauterine or ectopic pregnancy. When women of child bearing potential undergo evaluation for clinical trial, it is often unclear what course of evaluation to take when a pregnancy test is positive. We describe the clinical course of a patient with widely metastatic mucinous ovarian carcinoma with metastasis to the peritoneum, lymph nodes and liver. The patient was found to have a mildly elevated β-hCG during initial evaluation for clinical trial. Extensive work up for ectopic pregnancy, trophoblastic disease, and phantom β-hCG were negative. The patient's β-hCG levels continued to rise until initiation of therapy. She was treated on a phase I protocol with restaging scans revealing a partial response. The β-hCG was retested and declined in conjunction with her response, consistent with paraneoplastic β-hCG. Here, we propose a decision making algorithm to evaluate a patient with an elevated β-hCG undergoing assessment for clinical trial.

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 case of direct intracranial extension of tuberculous otitis media.

PubMed

Kim, Dong-Kee; Park, Shi-Nae; Park, Kyung-Ho; Yeo, Sang Won

2014-02-01

We describe a very rare case of tuberculous otitis media (TOM) with direct intracranial extension. The patient was a 55-year-old man who presented to our ENT clinic for evaluation of severe headaches and right-sided otorrhea. A biopsy of granulation tissue obtained from the right external auditory canal demonstrated chronic inflammation that was suggestive of mycobacterial infection. Magnetic resonance imaging of the brain indicated intracranial extension of TOM through a destroyed tegmen mastoideum. After 2 months of antituberculous medication, the headaches and otorrhea were controlled, and the swelling in the external ear canal subsided greatly. Rarely does TOM spread intracranially. In most such cases, intracranial extension of tuberculosis occurs as the result of hematogenous or lymphogenous spread. In rare cases, direct spread through destroyed bone can occur, as it did in our patient.

Evaluation of RSA set-up from a clinical biplane fluoroscopy system for 3D joint kinematic analysis.

PubMed

Bonanzinga, Tommaso; Signorelli, Cecilia; Bontempi, Marco; Russo, Alessandro; Zaffagnini, Stefano; Marcacci, Maurilio; Bragonzoni, Laura

2016-01-01

dinamic roentgen stereophotogrammetric analysis (RSA), a technique currently based only on customized radiographic equipment, has been shown to be a very accurate method for detecting three-dimensional (3D) joint motion. The aim of the present work was to evaluate the applicability of an innovative RSA set-up for in vivo knee kinematic analysis, using a biplane fluoroscopic image system. To this end, the Authors describe the set-up as well as a possible protocol for clinical knee joint evaluation. The accuracy of the kinematic measurements is assessed. the Authors evaluated the accuracy of 3D kinematic analysis of the knee in a new RSA set-up, based on a commercial biplane fluoroscopy system integrated into the clinical environment. The study was organized in three main phases: an in vitro test under static conditions, an in vitro test under dynamic conditions reproducing a flexion-extension range of motion (ROM), and an in vivo analysis of the flexion-extension ROM. For each test, the following were calculated, as an indication of the tracking accuracy: mean, minimum, maximum values and standard deviation of the error of rigid body fitting. in terms of rigid body fitting, in vivo test errors were found to be 0.10±0.05 mm. Phantom tests in static and kinematic conditions showed precision levels, for translations and rotations, of below 0.1 mm/0.2° and below 0.5 mm/0.3° respectively for all directions. the results of this study suggest that kinematic RSA can be successfully performed using a standard clinical biplane fluoroscopy system for the acquisition of slow movements of the lower limb. a kinematic RSA set-up using a clinical biplane fluoroscopy system is potentially applicable and provides a useful method for obtaining better characterization of joint biomechanics.

Attitudes of affiliate faculty members toward medical student summative evaluation for clinical clerkships: a qualitative analysis.

PubMed

Wang, Karen E; Fitzpatrick, Caroline; George, David; Lane, Lindsey

2012-01-01

Summative evaluation of medical students is a critical component of the educational process. Despite extensive literature on evaluation, few studies have centered on affiliate faculty members' attitudes toward summative evaluation of students, though it has been suggested that these attitudes influence their effectiveness as evaluators. The objective is to examine affiliate faculty members' attitudes toward clinical clerkship evaluation using primarily qualitative research methods. The study used a nonexperimental research design and employed mixed methods. Data were collected through interviews, focus groups, and a questionnaire from 11 affiliate faculty members. Themes emerging from the data fell into three broad categories: (a) factors that influence grading, (b) consequences of negative evaluations, and (c) disconnections in the grading process. The quantitative portion of the study revealed important discrepancies supporting the use of qualitative methods. The study highlights faculty members' struggles with the evaluative process and emphasizes the need for improvements in evaluation tools and faculty development.

Establishing semantic interoperability of biomedical metadata registries using extended semantic relationships.

PubMed

Park, Yu Rang; Yoon, Young Jo; Kim, Hye Hyeon; Kim, Ju Han

2013-01-01

Achieving semantic interoperability is critical for biomedical data sharing between individuals, organizations and systems. The ISO/IEC 11179 MetaData Registry (MDR) standard has been recognized as one of the solutions for this purpose. The standard model, however, is limited. Representing concepts consist of two or more values, for instance, are not allowed including blood pressure with systolic and diastolic values. We addressed the structural limitations of ISO/IEC 11179 by an integrated metadata object model in our previous research. In the present study, we introduce semantic extensions for the model by defining three new types of semantic relationships; dependency, composite and variable relationships. To evaluate our extensions in a real world setting, we measured the efficiency of metadata reduction by means of mapping to existing others. We extracted metadata from the College of American Pathologist Cancer Protocols and then evaluated our extensions. With no semantic loss, one third of the extracted metadata could be successfully eliminated, suggesting better strategy for implementing clinical MDRs with improved efficiency and utility.

When Supervision Is Conflated with Evaluation: Teacher Candidates' Perceptions of Their Novice Supervisor

ERIC Educational Resources Information Center

Burns, Rebecca West; Badiali, Bernard J.

2015-01-01

Preparing teachers in clinically rich contexts requires teacher educators who are skilled and knowledgeable about university coursework as well as the complexities of classrooms. Retired teachers or principals have often assumed the role of field supervisor, bringing to their work extensive practitioner knowledge but often lacking theoretical…

Double-Deficit Hypothesis in a Clinical Sample: Extension beyond Reading

ERIC Educational Resources Information Center

Heikkilä, Riikka; Torppa, Minna; Aro, Mikko; Närhi, Vesa; Ahonen, Timo

2016-01-01

This study explored the double-deficit hypothesis (DDH) in a transparent orthography (Finnish) and extended the view from reading disabilities to comorbidity of learning-related problems in math and attention. Children referred for evaluation of learning disabilities in second through sixth grade (N = 205) were divided into four groups based on…

Clinical manifestations of trisomy 4p syndrome.

PubMed

Patel, S V; Dagnew, H; Parekh, A J; Koenig, E; Conte, R A; Macera, M J; Verma, R S

1995-06-01

Trisomy 4p syndrome is a distinct clinical entity which was noted almost a quarter century ago by Wilson et al. [71] and later was delineated by Gonzalez and colleagues [29]. The variation in the length of duplicated segment usually associated with monosomy of other genetic material which has resulted in confusion and as a result a so-called 4p syndrome could not be recognized without cytogenetic analysis. We wish to draw the attention of clinicians to this subject by presenting the description of over 75 cases including one from our clinic and stress the point that molecular approaches are imperative to characterize this anomaly. After extensive review, it appears that patients retaining at least the distal two-thirds to the entire short arm share an overlapping phenotypic expression that constitutes pure trisomy 4p syndrome which includes prominent glabella, bulbous nose with flat or depressed nasal bridge, retrognathia, pointed chin, short neck with low hairline, enlarged ears with abnormal helix and antihelix, rocker-bottom feet with prominent heel. Arachnodactyly and camptodactyly. Molecular characterization of 4p is imperative. We have also included an extensive bibliography for clinicians who may find it useful as a single reference source for evaluating their future cases. The 4p-syndrome is a distinct entity but without cytogenetic evaluation, the syndrome can not be recognized.

Evaluation of the William S. Hall Psychiatric Institute Clinical Psychology Internship: a replication and extension.

PubMed

Stader, Sandra R; Myers, DeRosset; Forand, Angela Q; Holmes, George R; McNulty, George F; Frey, Linda; Bolton, Staci S

2010-12-01

This study extends three earlier investigations involving participants who completed their predoctoral clinical psychology internship at the William S. Hall Psychiatric Institute. Intern graduates (N = 37) evaluated how effectively their internship training prepared them for seven aspects of their current work as practicing psychologists. Participants also rated the relevancy of 24 different internship training experiences to their current work and how much these experiences contributed to their development as clinical psychologists. The present study, in conjunction with the three previous studies, covers most of the 40-year period since the inception of the internship program. Analysis of the current data indicates the internship has improved over time and was deemed an exceptional training experience by its graduates. Findings may be of particular interest to internship directors and faculty interested in improving their training program and those who plan to conduct a self-study to maintain their accreditation for clinical psychology internship.

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.

Long-term outcome of percutaneous alcohol embolization combined with percutaneous vertebroplasty in aggressive vertebral hemangiomas with epidural extension.

PubMed

Premat, Kévin; Clarençon, Frédéric; Cormier, Évelyne; Mahtout, Jugurtha; Bonaccorsi, Raphaël; Degos, Vincent; Chiras, Jacques

2017-07-01

To evaluate, on a long-term basis, the safety and effectiveness of percutaneous alcohol embolization (PAE) combined with percutaneous vertebroplasty (PVP) as a sole treatment for aggressive vertebral haemangiomas (AVHs) with epidural extension. From 1996 to 2015, 26 consecutive patients (15 women [58%] and 11 men; mean age 51.8 years [range: 19-75 years]) underwent PAE combined with PVP (performed at day 15) for the treatment of 27 AVHs with epidural extension. Clinical outcome was evaluated with a mean delay of 88.3 ± 53.3 months (range: 22-217 months). The primary endpoint was pain relief evaluated with a visual analogue scale (VAS). Pre-procedure mean VAS score was 7.23 ± 1.3 and significantly improved at last follow-up (m = 3.11 ± 1.9; p < 0.001). Ten patients (38.5%) remained asymptomatic. Eighty-eight percent of the patients with neurosensory disorders had complete regression of these symptoms. Two of the three patients with motor deficit did not show any improvement. No major complication was recorded. PAE combined with PVP is a minimally invasive safe and effective therapeutic approach for AVH with epidural involvement, even on long-term clinical outcome. This technique appears mainly effective for pain and neurosensory symptoms, but seems less effective for motor deficit relief. • Combination of PAE with PVP is a safe technique. • PAE combined with PVP is an effective treatment for sensory symptoms. • This strategy seems less effective in patients with motor deficits.

Bone quality and the immediate loading of implants-critical aspects based on literature, research, and clinical experience.

PubMed

Romanos, Georgios E

2009-06-01

Immediate loading of oral implants has been extensively described in the international literature and the requirements for long-term success are evaluated. The author presents here the critical aspects of the criteria for success as well as describes the characteristics of an implant macro- and microdesign for immediate loading to control the periimplant crestal bone loss and secure the long-term stability. Information from the literature and the clinical experience will be presented.

PET/SPECT: Instrumentation, radiopharmaceuticals, neurology and physiological measurement. Proceedings

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

Not Available

1988-12-31

The following collection of papers was presented at the Department of Energy sponsored symposium ``Frontiers in Nuclear Medicine - PET/SPECT 1987`` held in Washington, D.C. September 27-- 28, 1987. The meeting and these manuscripts concentrate on the techniques of tomography, useful radiopharmaceuticals, and clinical neurologic and cardiac evaluation. The authors of these papers are for the most part those who either developed the techniques or who have extensively applied them to clinical practice. Individual reports are processed separately for the databases.

More Accurate Definition of Clinical Target Volume Based on the Measurement of Microscopic Extensions of the Primary Tumor Toward the Uterus Body in International Federation of Gynecology and Obstetrics Ib-IIa Squamous Cell Carcinoma of the Cervix

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

Xie, Wen-Jia; Wu, Xiao; Xue, Ren-Liang

Purpose: To more accurately define clinical target volume for cervical cancer radiation treatment planning by evaluating tumor microscopic extension toward the uterus body (METU) in International Federation of Gynecology and Obstetrics stage Ib-IIa squamous cell carcinoma of the cervix (SCCC). Patients and Methods: In this multicenter study, surgical resection specimens from 318 cases of stage Ib-IIa SCCC that underwent radical hysterectomy were included. Patients who had undergone preoperative chemotherapy, radiation, or both were excluded from this study. Microscopic extension of primary tumor toward the uterus body was measured. The association between other pathologic factors and METU was analyzed. Results: Microscopicmore » extension toward the uterus body was not common, with only 12.3% of patients (39 of 318) demonstrating METU. The mean (±SD) distance of METU was 0.32 ± 1.079 mm (range, 0-10 mm). Lymphovascular space invasion was associated with METU distance and occurrence rate. A margin of 5 mm added to gross tumor would adequately cover 99.4% and 99% of the METU in the whole group and in patients with lymphovascular space invasion, respectively. Conclusion: According to our analysis of 318 SCCC specimens for METU, using a 5-mm gross tumor volume to clinical target volume margin in the direction of the uterus should be adequate for International Federation of Gynecology and Obstetrics stage Ib-IIa SCCC. Considering the discrepancy between imaging and pathologic methods in determining gross tumor volume extent, we recommend a safer 10-mm margin in the uterine direction as the standard for clinical practice when using MRI for contouring tumor volume.« less

Elbow arthroscopy: valgus extension overload.

PubMed

Ahmad, Christopher S; Conway, John E

2011-01-01

Valgus torque combined with deceleration produces high compression and shear forces acting on the posteromedial olecranon and the posteromedial trochlea. This valgus extension overload process may cause posteromedial trochlea chondromalacia, chondral flap formation, osteochondrosis, subchondral erosion, a subchondral insufficiency fracture, and marginal exostosis formation. Olecranon pathologies include proximal stress reaction, a posteromedial tip stress fracture, a transverse proximal process stress fracture, exostosis formation, exostosis fragmentation, and intra-articular loose bodies. Symptoms include posteromedial elbow pain during the deceleration phase of the throwing motion. The extension impingement test reproduces posterior or posteromedial pain similar to that experienced while throwing. Special radiographic techniques and CT scans can show loose bodies and osteophyte fragmentation. Surgical treatment is indicated when symptoms persist despite nonsurgical management. Based on clinical and basic science research, all patients with valgus extension overload should be comprehensively evaluated for medial ulnar collateral ligament insufficiency. Surgical treatment is limited to the resection of osteophytes only; normal olecranon should not be resected.

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

PubMed

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

2014-10-01

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

SPR741, an Antibiotic Adjuvant, Potentiates the In Vitro and In Vivo Activity of Rifampin against Clinically Relevant Extensively Drug-Resistant Acinetobacter baumannii

PubMed Central

Reinhart, Alexandria A.; Alamneh, Yonas A.; Pucci, Michael J.; Si, Yuanzheng; Abu-Taleb, Rania; Shearer, Jonathan P.; Demons, Samandra T.; Tyner, Stuart D.; Lister, Troy

2017-01-01

ABSTRACT Acinetobacter baumannii is responsible for 10% of all nosocomial infections and has >50% mortality rates when causing ventilator-associated pneumonia. In this proof-of-concept study, we evaluated SPR741, an antibiotic adjuvant that permeabilizes the Gram-negative membrane, in combination with rifampin against AB5075, an extensively drug-resistant (XDR) A. baumannii strain. In standard in vitro assays and in a murine pulmonary model, we found that this drug combination can significantly reduce bacterial burden and promote animal survival despite an aggressive infection. PMID:28947471

The MiPACQ Clinical Question Answering System

PubMed Central

Cairns, Brian L.; Nielsen, Rodney D.; Masanz, James J.; Martin, James H.; Palmer, Martha S.; Ward, Wayne H.; Savova, Guergana K.

2011-01-01

The Multi-source Integrated Platform for Answering Clinical Questions (MiPACQ) is a QA pipeline that integrates a variety of information retrieval and natural language processing systems into an extensible question answering system. We present the system’s architecture and an evaluation of MiPACQ on a human-annotated evaluation dataset based on the Medpedia health and medical encyclopedia. Compared with our baseline information retrieval system, the MiPACQ rule-based system demonstrates 84% improvement in Precision at One and the MiPACQ machine-learning-based system demonstrates 134% improvement. Other performance metrics including mean reciprocal rank and area under the precision/recall curves also showed significant improvement, validating the effectiveness of the MiPACQ design and implementation. PMID:22195068

The MiPACQ clinical question answering system.

PubMed

Cairns, Brian L; Nielsen, Rodney D; Masanz, James J; Martin, James H; Palmer, Martha S; Ward, Wayne H; Savova, Guergana K

2011-01-01

The Multi-source Integrated Platform for Answering Clinical Questions (MiPACQ) is a QA pipeline that integrates a variety of information retrieval and natural language processing systems into an extensible question answering system. We present the system's architecture and an evaluation of MiPACQ on a human-annotated evaluation dataset based on the Medpedia health and medical encyclopedia. Compared with our baseline information retrieval system, the MiPACQ rule-based system demonstrates 84% improvement in Precision at One and the MiPACQ machine-learning-based system demonstrates 134% improvement. Other performance metrics including mean reciprocal rank and area under the precision/recall curves also showed significant improvement, validating the effectiveness of the MiPACQ design and implementation.

FDA's perspectives on cardiovascular devices.

PubMed

Chen, Eric A; Patel-Raman, Sonna M; O'Callaghan, Kathryn; Hillebrenner, Matthew G

2009-06-01

The Food and Drug Administration (FDA) decision process for approving or clearing medical devices is often determined by a review of robust clinical data and extensive preclinical testing of the device. The mission statement for the Center for Devices and Radiological Health (CDRH) is to review the information provided by manufacturers so that it can promote and protect the health of the public by ensuring the safety and effectiveness of medical devices deemed appropriate for human use (Food, Drug & Cosmetic Act, Section 903(b)(1, 2(C)), December 31, 2004; accessed December 17, 2008 http://www.fda.gov/opacom/laws/fdcact/fdctoc.htm). For high-risk devices, such as ventricular assist devices (VADs), mechanical heart valves, stents, cardiac resynchronization therapy (CRT) devices, pacemakers, and defibrillators, the determination is based on FDA's review of extensive preclinical bench and animal testing followed by use of the device in a clinical trial in humans. These clinical trials allow the manufacturer to evaluate a device in the intended use population. FDA reviews the data from the clinical trial to determine if the device performed as predicted and the clinical benefits outweigh the risks. This article reviews the regulatory framework for different marketing applications related to cardiovascular devices and describes the process of obtaining approval to study a cardiovascular device in a U.S. clinical trial.

An Innovative Regenerative Endodontic Procedure Using Leukocyte and Platelet-rich Fibrin Associated with Apical Surgery: A Case Report.

PubMed

Pinto, Nelson; Harnish, Alexandra; Cabrera, Carolina; Andrade, Catherine; Druttman, Tony; Brizuela, Claudia

2017-11-01

Regenerative endodontic procedures (REPs) associated with apical surgery could represent an alternative treatment strategy for patients whose teeth present incomplete root formation and extensive apical lesions. Leukocyte platelet-rich fibrin (L-PRF) has potential benefits in REPs; it could promote apical root formation and optimal bone healing. The aim of this case report was to describe innovative regenerative endodontic therapy using L-PRF in the root canal and an extensive apical lesion in an immature tooth with dens invaginatus and asymptomatic apical periodontitis. A healthy 20-year-old woman was referred to the dental clinic of the Universidad de Los Andes, Santiago, Chile, for endodontic treatment in tooth # 22 with incomplete root development and an extensive apical lesion. The diagnosis was asymptomatic apical periodontitis associated with dens invaginatus type II. The patient was treated with an innovative approach using L-PRF in REPs associated with apical surgery. Follow-ups were performed at 6 months and 1 year later. They included periapical radiographs, cone-beam computed tomographic imaging, sensitivity, and vitality tests. The clinical evaluations performed at 6 months and 1 year revealed an absence of symptoms. The radiographic evaluations showed that the apical lesion was resolved. The cone-beam images indicated that the root length increased and the walls had thickened. The sensitivity tests were positive, and the laser Doppler flowmetry showed positive blood flow after 1 year. The success of the results in this case report indicate that L-PRF can be used as a complement in apical surgery and REPs and could provide an innovative alternative treatment strategy for complex clinical cases like these. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Clinical, morphological, and molecular characterization of Penicillium canis, sp. nov., isolated from a dog with osteomyelitis

USDA-ARS?s Scientific Manuscript database

Infections caused by Penicillium spp. are rare in dogs, and the prognosis in these cases is poor. An unknown species of Penicillium was isolated from a bone lesion in a young dog with osteomyelitis of the right ilium. Extensive diagnostic evaluation did not reveal evidence of dissemination. Resoluti...

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

PubMed

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

2016-04-01

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

Role of Genetics in the Etiology of Autistic Spectrum Disorder: Towards a Hierarchical Diagnostic Strategy

PubMed Central

Robert, Cyrille; Pasquier, Laurent; Cohen, David; Fradin, Mélanie; Canitano, Roberto; Damaj, Léna; Odent, Sylvie; Tordjman, Sylvie

2017-01-01

Progress in epidemiological, molecular and clinical genetics with the development of new techniques has improved knowledge on genetic syndromes associated with autism spectrum disorder (ASD). The objective of this article is to show the diversity of genetic disorders associated with ASD (based on an extensive review of single-gene disorders, copy number variants, and other chromosomal disorders), and consequently to propose a hierarchical diagnostic strategy with a stepwise evaluation, helping general practitioners/pediatricians and child psychiatrists to collaborate with geneticists and neuropediatricians, in order to search for genetic disorders associated with ASD. The first step is a clinical investigation involving: (i) a child psychiatric and psychological evaluation confirming autism diagnosis from different observational sources and assessing autism severity; (ii) a neuropediatric evaluation examining neurological symptoms and developmental milestones; and (iii) a genetic evaluation searching for dysmorphic features and malformations. The second step involves laboratory and if necessary neuroimaging and EEG studies oriented by clinical results based on clinical genetic and neuropediatric examinations. The identification of genetic disorders associated with ASD has practical implications for diagnostic strategies, early detection or prevention of co-morbidity, specific treatment and follow up, and genetic counseling. PMID:28287497

Role of Genetics in the Etiology of Autistic Spectrum Disorder: Towards a Hierarchical Diagnostic Strategy.

PubMed

Robert, Cyrille; Pasquier, Laurent; Cohen, David; Fradin, Mélanie; Canitano, Roberto; Damaj, Léna; Odent, Sylvie; Tordjman, Sylvie

2017-03-12

Progress in epidemiological, molecular and clinical genetics with the development of new techniques has improved knowledge on genetic syndromes associated with autism spectrum disorder (ASD). The objective of this article is to show the diversity of genetic disorders associated with ASD (based on an extensive review of single-gene disorders, copy number variants, and other chromosomal disorders), and consequently to propose a hierarchical diagnostic strategy with a stepwise evaluation, helping general practitioners/pediatricians and child psychiatrists to collaborate with geneticists and neuropediatricians, in order to search for genetic disorders associated with ASD. The first step is a clinical investigation involving: (i) a child psychiatric and psychological evaluation confirming autism diagnosis from different observational sources and assessing autism severity; (ii) a neuropediatric evaluation examining neurological symptoms and developmental milestones; and (iii) a genetic evaluation searching for dysmorphic features and malformations. The second step involves laboratory and if necessary neuroimaging and EEG studies oriented by clinical results based on clinical genetic and neuropediatric examinations. The identification of genetic disorders associated with ASD has practical implications for diagnostic strategies, early detection or prevention of co-morbidity, specific treatment and follow up, and genetic counseling.

Long-term outcome in BRAF(V600E) melanoma patients treated with vemurafenib: Patterns of disease progression and clinical management of limited progression.

PubMed

Puzanov, Igor; Amaravadi, Ravi K; McArthur, Grant A; Flaherty, Keith T; Chapman, Paul B; Sosman, Jeffrey A; Ribas, Antoni; Shackleton, Mark; Hwu, Patrick; Chmielowski, Bartosz; Nolop, Keith B; Lin, Paul S; Kim, Kevin B

2015-07-01

Vemurafenib induces tumour regression in most patients with BRAF(V600E)-mutant melanoma; eventually, most experience progressive disease (PD). Long-term follow-up of patients with BRAF(V600E) melanoma treated in the phase 1 vemurafenib trial is reported. Patients received vemurafenib 240-1120 mg (dose escalation cohort) or 960 mg (extension cohort) orally twice daily. Clinical response was evaluated every 8 weeks by Response Evaluation Criteria In Solid Tumors (RECIST). Patients with PD amenable to local therapy (surgery or radiotherapy) were allowed to continue vemurafenib after progression. Overall survival (OS) from time of treatment initiation and from PD was estimated. Sites of PD were recorded. Forty-eight patients (escalation cohort, n = 16; extension cohort, n = 32) received therapeutic doses of vemurafenib (⩾ 240 mg twice daily). Forty-four patients had PD by the time of this analysis and four remained progression free (follow-up time, 1.2-56.1 months). Median OS was 14 months (range, 1.2-56.1); 3- and 4-year melanoma-specific survival rate in the extension cohort was 26% and 19%, respectively. Median OS was 26.0 months (range, 7.7-56.1) among 20 patients who continued vemurafenib after local therapy. Median treatment duration beyond initial PD was 3.8 months (range, 1.1-26.6). In the extension cohort, six and five patients were alive after 3 and 4 years, respectively, on vemurafenib monotherapy. Some patients with melanoma achieved long-term survival with vemurafenib monotherapy. Continuation of vemurafenib after PD might be beneficial in some patients because remaining disease might continue to respond to BRAF inhibition. Copyright © 2015 Elsevier Ltd. All rights reserved.

Several down, a few to go: histamine H3 receptor ligands making the final push towards the market?

PubMed

Kuhne, Sebastiaan; Wijtmans, Maikel; Lim, Herman D; Leurs, Rob; de Esch, Iwan J P

2011-12-01

The histamine H(3) receptor (H(3)R) plays a pivotal role in a plethora of therapeutic areas. Blocking the H(3)R with antagonists/inverse agonists has been postulated to be of broad therapeutic use. Indeed, H(3)R antagonists/inverse agonists have been extensively evaluated in the clinic. Here, we address new developments, insights obtained and challenges encountered in the clinical evaluations. For recent H(3)R clinical candidates, the status and results of the corresponding clinical trial(s) will be discussed along with preclinical data. In all, it becomes evident that clinical evaluation of H(3)R antagonists/inverse agonists is characterized by mixed results. On one hand, Pitolisant has successfully passed several Phase II trials and seems to be the most advanced compound in the clinic now, being in Phase III. On the other hand, some compounds (e.g., PF-03654647 and MK-0249) failed at Phase II clinical level for several indications. A challenging feature in H(3)R research is the multifaceted role of the receptor at a molecular/biochemical level, which can complicate targeting by small molecules at several (pre)clinical levels. Accordingly, H(3)R antagonists/inverse agonists require further testing to pinpoint the determinants for clinical efficacy and to aid in the final push towards the market.

Assessment and revision of clinical pharmacy practice internet web sites.

PubMed

Edwards, Krystal L; Salvo, Marissa C; Ward, Kristina E; Attridge, Russell T; Kiser, Katie; Pinner, Nathan A; Gallegos, Patrick J; Kesteloot, Lori Lynn; Hylton, Ann; Bookstaver, P Brandon

2014-02-01

Health care professionals, trainees, and patients use the Internet extensively. Editable Web sites may contain inaccurate, incomplete, and/or outdated information that may mislead the public's perception of the topic. To evaluate the editable, online descriptions of clinical pharmacy and pharmacist and attempt to improve their accuracy. The authors identified key areas within clinical pharmacy to evaluate for accuracy and appropriateness on the Internet. Current descriptions that were reviewed on public domain Web sites included: (1) clinical pharmacy and the clinical pharmacist, (2) pharmacy education, (3) clinical pharmacy and development and provision for reimbursement, (4) clinical pharmacists and advanced specialty certifications/training opportunities, (5) pharmacists and advocacy, and (6) clinical pharmacists and interdisciplinary/interprofessional content. The authors assessed each content area to determine accuracy and prioritized the need for updating, when applicable, to achieve consistency in descriptions and relevancy. The authors found that Wikipedia, a public domain that allows users to update, was consistently the most common Web site produced in search results. The authors' evaluation resulted in the creation or revision of 14 Wikipedia Web pages. However, rejection of 3 proposed newly created Web pages affected the authors' ability to address identified content areas with deficiencies and/or inaccuracies. Through assessing and updating editable Web sites, the authors strengthened the online representation of clinical pharmacy in a clear, cohesive, and accurate manner. However, ongoing assessments of the Internet are continually needed to ensure accuracy and appropriateness.

Reliability and validity of clinical tests to assess the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders: Part 1-A systematic review from the Cervical Assessment and Diagnosis Research Evaluation (CADRE) Collaboration.

PubMed

Lemeunier, Nadège; da Silva-Oolup, S; Chow, N; Southerst, D; Carroll, L; Wong, J J; Shearer, H; Mastragostino, P; Cox, J; Côté, E; Murnaghan, K; Sutton, D; Côté, P

2017-09-01

To determine the reliability and validity of clinical tests to assess the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders. We updated the systematic review of the 2000-2010 Bone and Joint Decade Task Force on Neck Pain and its Associated Disorders. We also searched the literature to identify studies on the reliability and validity of Doppler velocimetry for the evaluation of cervical arteries. Two independent reviewers screened and critically appraised studies. We conducted a best evidence synthesis of low risk of bias studies and ranked the phases of investigations using the classification proposed by Sackett and Haynes. We screened 9022 articles and critically appraised 8 studies; all 8 studies had low risk of bias (three reliability and five validity Phase II-III studies). Preliminary evidence suggests that the extension-rotation test may be reliable and has adequate validity to rule out pain arising from facet joints. The evidence suggests variable reliability and preliminary validity for the evaluation of cervical radiculopathy including neurological examination (manual motor testing, dermatomal sensory testing, deep tendon reflexes, and pathological reflex testing), Spurling's and the upper limb neurodynamic tests. No evidence was found for doppler velocimetry. Little evidence exists to support the use of clinical tests to evaluate the anatomical integrity of the cervical spine in adults with neck pain and its associated disorders. We found preliminary evidence to support the use of the extension-rotation test, neurological examination, Spurling's and the upper limb neurodynamic tests.

Is the Treatment with Biological or Non-biological DMARDS a Modifier of Periodontal Condition in Patients with Rheumatoid Arthritis?

PubMed

Romero-Sanchez, Consuelo; Rodríguez, C; Santos-Moreno, P; Mesa, A M; Lafaurie, G I; Giraldo-Q, S; De-Avila, J; Castillo, D M; Duran, M; Chalem, P Ch; Bello Gualtero, J M; Valle-Oñate, R

2017-01-01

Experimental models suggest the use of different therapy protocols in rheumatoid arthritis (RA) as modulators on periodontal condition. This study evaluated the effects of conventional drug treatment and anti-TNF therapy in patients with RA on microbiological and periodontal condition, establishing the association of markers of periodontal infection with indexes of rheumatic activity. One hundred seventy nine individuals with RA were evaluated (62 with anti-TNF-. and 115 with only DMARDs). The periodontal evaluation included plaque and gingival indexes, bleeding on probing (BOP), clinical attachment loss (CAL), pocket depth (PD) and subgingival plaque samples for microbiological analysis. Rheumatologic evaluations included a clinical examination, rheumatoid factor (RF), antibodies against cyclic-citrullinated peptides (ACPAs), and activity markers (DAS28-ERS), high sensitive C-reactive protein (hs-CRP), erythrocyte sedimentation rate (ESR). Anti-TNF-alpha therapy influenced periodontal microbiota with a higher frequency of T. denticola (p=0.01). Methotrexate combined with leflunomide exhibited a higher extension of CAL (p=0.005), and anti-TNF-alpha therapy with methotrexate was associated with a lower extension of CAL (p=0.05). The use of corticosteroids exerted a protective effect on the number of teeth (p=0.027). The type of DMARD affected P. gingivalis, T. forsythia and E. nodatum presence. Elevated ACPAs titers were associated with the presence of red complex periodontal pathogens (p=0.025). Bleeding on probing was associated with elevated CPR levels (p=0.05), and ESR was associated with a greater PD (p=0.044) and presence of red complex (p=0.030). Different pharmacological treatments for RA affect the clinical condition and subgingival microbiota. Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.org.

The difference in centre position in the ACL femoral footprint inclusive and exclusive of the fan-like extension fibres.

PubMed

Iriuchishima, Takanori; Ryu, Keinosuke; Aizawa, Shin; Fu, Freddie H

2016-01-01

The purpose of this study was to compare the centre position of each anterior cruciate ligament bundle in its femoral footprint in measurements including and excluding the fan-like extension fibres. Fourteen non-paired human cadaver knees were used. All soft tissues around the knee were resected except the ligaments. The ACL was divided into antero-medial (AM) and postero-lateral (PL) bundles according to the difference in tension patterns. The ACL was carefully dissected, and two outlines were made of the periphery of each bundle insertion site: those which included and those which excluded the fan-like extension fibres. An accurate lateral view of the femoral condyle was photographed with a digital camera, and the images were downloaded to a personal computer. The centre position of each bundle, including and excluding the fan-like extension fibres, was measured with ImageJ software (National Institution of Health). Evaluation of the centre position was performed using the modified quadrant method. The centre of the femoral AM bundle including the fan-like extension was located at 28.8% in a shallow-deep direction and 37.2% in a high-low direction. When the AM bundle was evaluated without the fan-like extension, the centre was significantly different at 34.6% in a shallow-deep direction (p = 0.000) and 36% in a high-low direction. The centre of the PL bundle including the fan-like extension was found at 37.1% in a shallow-deep direction and 73.4% in a high-low direction. When the PL bundle was evaluated without the fan-like extension, the centre was significantly different at 42.7% in a shallow-deep direction (p = 0.000) and 69.3% in a high-low direction (p = 0.000). The centre position of the AM and PL bundles in the femoral ACL footprint was significantly different depending on the inclusion or exclusion of the fan-like extension fibres. For the clinical relevance, to reproduce the direct femoral insertion in the anatomical ACL reconstruction, tunnels should be placed relatively shallow and high in the femoral ACL footprint.

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.

Giant multilevel thoracic hemangioma with spinal cord compression in a patient with Klippel-Weber-Trenaunay syndrome: case report.

PubMed

Grau, Stefan J; Holtmannspoetter, Markus; Seelos, Klaus; Tonn, Joerg-Christian; Siefert, Axel

2009-06-15

Case report and clinical discussion. We intend to report a very rare case of a giant spinal hemangioma causing myelopathy. Multilevel symptomatic spinal hemangiomas causing acute neurologic symptoms are rare disorders. We found only sporadic reports in English literature. We describe a very rare case in which Klippel-Trenaunay-Weber syndrome is associated with a multisegmental vertebral hemangioma causing a rapidly progressing thoracic myelopathy. Because of the extension of the disease, surgical intervention was not feasible, the patient was treated by radiotherapy. The patient showed a complete regression of symptoms with stable condition after 3 months. In extensive spinal hemangiomas, radiotherapy may represent a safe treatment modality with rapid clinical improvement even in cases with spinal cord compression. This report contributes to a wide range of known vascular abnormalities in Klippel-Trenaunay-Weber syndrome and supports the need for a careful multisystemic evaluation of these patients.

Clinical significance of achieving a flexion limitation with a tension band system in grade 1 degenerative spondylolisthesis: a minimum 5-year follow-up.

PubMed

Lee, Sang-Ho; Lee, Ho-Yeon; Baek, Oon Ki; Bae, Jun Seok; Yoo, Seung-Hwa; Lee, June-Ho

2015-03-15

Retrospective clinical study. To evaluate the effect of the limitation of flexion rotation clinically and radiologically after interspinous soft stabilization using a tension band system in grade 1 degenerative spondylolisthesis. Although several studies have been published on the clinical effects of limiting rotatory motion using tension band systems, which mainly targets the limitation of flexion rather than that of extension, they were confined to the category of pedicle screw-based systems, revealing inconsistent long-term outcomes. Sixty-one patients with a mean age of 60.6 years (range, 28-76 yr) who underwent interspinous soft stabilization after decompression for grade 1 degenerative spondylolisthesis with stenosis between 2002 and 2004 were analyzed. At follow-up, the patients were divided into 2 groups on the basis of their achievement or failure to achieve flexion limitation. The clinical and radiological findings were analyzed. A multiple linear regression analysis was performed to determine the prognostic factors for surgical outcomes. At a mean follow-up duration of 72.5 months (range, 61-82 mo), 51 patients were classified into the flexion-limited group and 10 into the flexion-unlimited group. Statistically significant improvements were noted only in the flexion-limited group in all clinical scores. In the flexion-unlimited group, there were significant deteriorations in flexion angle (P = 0.009), axial thickness of the ligamentum flavum (P = 0.013), and the foraminal cross-sectional area (P = 0.011), resulting in significant intergroup differences. The preoperative extension angle was identified as the most influential variable for the flexion limitation and the clinical outcomes. The effects of the limitation of flexion rotation achieved through interspinous soft stabilization using a tension band system after decompression were related to the prevention of late recurrent stenosis and resultant radicular pain caused by flexion instability. The extension potential at the index level was recognized as a major prognostic factor that can predict the flexion limitation and the clinical results. 4.

The impact of clinical nurse specialists on clinical pathways in the application of evidence-based practice.

PubMed

Gurzick, Martha; Kesten, Karen S

2010-01-01

The purpose of this article was to address the call for evidence-based practice through the development of clinical pathways and to assert the role of the clinical nurse specialist (CNS) as a champion in clinical pathway implementation. In the current health care system, providing quality of care while maintaining cost-effectiveness is an ever-growing battle that institutions face. The CNS's role is central to meeting these demands. An extensive literature review has been conducted to validate the use of clinical pathways as a means of improving patient outcomes. This literature also suggests that clinical pathways must be developed, implemented, and evaluated utilizing validated methods including the use of best practice standards. Execution of clinical pathways should include a clinical expert, who has the ability to look at the system as a whole and can facilitate learning and change by employing a multitude of competencies while maintaining a sphere of influence over patient and families, nurses, and the system. The CNS plays a pivotal role in influencing effective clinical pathway development, implementation, utilization, and ongoing evaluation to ensure improved patient outcomes and reduced costs. This article expands upon the call for evidence-based practice through the utilization of clinical pathways to improve patient outcomes and reduce costs and stresses the importance of the CNS as a primary figure for ensuring proper pathway development, implementation, and ongoing evaluation. Copyright 2010 Elsevier Inc. All rights reserved.

Simulation of realistic retinoscopic measurement

NASA Astrophysics Data System (ADS)

Tan, Bo; Chen, Ying-Ling; Baker, K.; Lewis, J. W.; Swartz, T.; Jiang, Y.; Wang, M.

2007-03-01

Realistic simulation of ophthalmic measurements on normal and diseased eyes is presented. We use clinical data of ametropic and keratoconus patients to construct anatomically accurate three-dimensional eye models and simulate the measurement of a streak retinoscope with all the optical elements. The results show the clinical observations including the anomalous motion in high myopia and the scissors reflex in keratoconus. The demonstrated technique can be applied to other ophthalmic instruments and to other and more extensively abnormal eye conditions. It provides promising features for medical training and for evaluating and developing ocular instruments.

Demystifying MR Neurography of the Lumbosacral Plexus: From Protocols to Pathologies

PubMed Central

Muniz Neto, Francisco J.; Kihara Filho, Eduardo N.; Miranda, Frederico C.; Rosemberg, Laercio A.; Santos, Durval C. B.

2018-01-01

Magnetic resonance neurography is a high-resolution imaging technique that allows evaluating different neurological pathologies in correlation to clinical and the electrophysiological data. The aim of this article is to present a review on the anatomy of the lumbosacral plexus nerves, along with imaging protocols, interpretation pitfalls, and most common pathologies that should be recognized by the radiologist: traumatic, iatrogenic, entrapment, tumoral, infectious, and inflammatory conditions. An extensive series of clinical and imaging cases is presented to illustrate key-points throughout the article. PMID:29662907

Excimer laser ablation of the cornea

NASA Astrophysics Data System (ADS)

Pettit, George H.; Ediger, Marwood N.; Weiblinger, Richard P.

1995-03-01

Pulsed ultraviolet laser ablation is being extensively investigated clinically to reshape the optical surface of the eye and correct vision defects. Current knowledge of the laser/tissue interaction and the present state of the clinical evaluation are reviewed. In addition, the principal findings of internal Food and Drug Administration research are described in some detail, including a risk assessment of the laser-induced-fluorescence and measurement of the nonlinear optical properties of cornea during the intense UV irradiation. Finally, a survey is presented of the alternative laser technologies being explored for this ophthalmic application.

Clinically applied procedures for human ovarian tissue cryopreservation result in different levels of efficacy and efficiency.

PubMed

Bastings, Lobke; Westphal, Johan R; Beerendonk, Catharina C M; Bekkers, Ruud L M; Zusterzeel, Petra L M; Hendriks, Jan C M; Braat, Didi D M; Peek, Ronald

2016-12-01

Different protocols are being used worldwide for the cryopreservation of human ovarian tissue for fertility preservation purposes. The efficiency and efficacy of the majority of these protocols has not been extensively evaluated, possibly resulting in sub-optimally cryopreserved ovarian tissue. To address the impact of this issue, we assessed the effects of two clinically successful human ovarian tissue slow-freezing cryopreservation procedures on the quality of the cryopreserved tissue. To differentiate between cryopreservation ( C ) versus thawing ( T ) related effects, four combinations of these two (A and B) very different cryopreservation/thawing protocols (A C A T , A C B T , B C A T , B C B T ) were studied. Before and after cryopreservation and thawing, the percentage of living and morphologically normal follicles, as well as the overall tissue viability, was assessed. Our experiments revealed that the choice of the cryopreservation protocol noticeably affected the overall tissue viability and percentage of living follicles, with a higher viability after protocol B C when compared to A C . No statistically significant differences in tissue viability were observed between the two thawing protocols, but thawing protocol B T required considerably more human effort and materials than thawing protocol A T . Tissue morphology was best retained using the B C A T combination. Our results indicate that extensive and systematical evaluation of clinically used protocols is warranted.

Clinical Significance of Epsilon Waves in Arrhythmogenic Cardiomyopathy.

PubMed

Protonotarios, Alexandros; Anastasakis, Aris; Tsatsopoulou, Adalena; Antoniades, Loizos; Prappa, Efstathia; Syrris, Petros; Tousoulis, Dimitrios; McKENNA, William J; Protonotarios, Nikos

2015-07-16

Epsilon waves are hallmark features of arrhythmogenic cardiomyopathy (ACM) but information about their clinical significance is variable. We evaluated epsilon wave prevalence, characteristics, and their clinical significance in an ACM population. Eighty-six unselected patients fulfilling the 2010 Task Force criteria were enrolled. Seventy-six of them were carriers of desmosomal mutations. All subjects were serially evaluated with standard 12-lead ECG and 2-dimensional echocardiography. Epsilon waves were evaluated in all precordial and inferior leads. Novel parameters assessed included their duration and precordial/inferior lead extension. Twenty-five subjects (29%) had epsilon waves that were present in lead V3 and beyond in 9, and in the inferior leads in 7. Epsilon waves were associated with right ventricular outflow tract (RVOT) (P = 0.001) but not RV posterior wall (P = 0.21), RV apex (P = 0.30), or left ventricular (P = 0.94) wall motion abnormalities. Patients with epsilon waves had increased RVOT diameter (P < 0.0001). Extension of epsilon waves in lead V3 and beyond was associated with increased epsilon wave duration (P = 0.002) and RVOT diameter (P = 0.04). The duration of epsilon waves was positively correlated with RVOT diameter (r = 0.70, P = 0.0001). Epsilon waves were also associated with episodes of sustained ventricular tachycardia (P = 0.004) but not with heart failure (P = 0.41) or sudden cardiac death (P = 0.31). Detection of epsilon waves on 12-lead ECG reflects significant RVOT involvement, which was associated with episodes of sustained ventricular tachycardia but not sudden cardiac death. © 2015 Wiley Periodicals, Inc.

The evaluation of family functioning by the family assessment device: a systematic review of studies in adult clinical populations.

PubMed

Staccini, Laura; Tomba, Elena; Grandi, Silvana; Keitner, Gabor I

2015-03-01

A large body of research, documenting the impact of a family's functioning on health outcomes, highlights the importance of introducing the evaluation of patients' family dynamics into clinical judgment. The Family Assessment Device (FAD) is a self-report questionnaire designed to assess specific dimensions of family functioning. This qualitative systematic review, which follows PRISMA guidelines, aimed to identify the FAD's clinimetric properties and to report the incremental utility of its inclusion in clinical settings. A thorough literature search was performed, using both computerized and manual searches, yielding a total of 148 studies that were included in this review. The FAD has been extensively used in a variety of research contexts. In the majority of studies it was able to discriminate between clinical populations and controls and among groups of patients with different illnesses. The FAD also showed good test-retest and concurrent reliability, and modest sensitivity to change after treatment. FAD-dysfunctional family functioning was related to several patient clinical outcomes, including lower recovery rates and adherence to treatment, longer recovery time, poorer quality of life, and increased risk of relapse and drop-out. The present review demonstrates that the FAD is a suitable instrument for the evaluation of family functioning both in clinical and research settings. © 2014 Family Process Institute.

SPR741, an Antibiotic Adjuvant, Potentiates the In Vitro and In Vivo Activity of Rifampin against Clinically Relevant Extensively Drug-Resistant Acinetobacter baumannii.

PubMed

Zurawski, Daniel V; Reinhart, Alexandria A; Alamneh, Yonas A; Pucci, Michael J; Si, Yuanzheng; Abu-Taleb, Rania; Shearer, Jonathan P; Demons, Samandra T; Tyner, Stuart D; Lister, Troy

2017-12-01

Acinetobacter baumannii is responsible for 10% of all nosocomial infections and has >50% mortality rates when causing ventilator-associated pneumonia. In this proof-of-concept study, we evaluated SPR741, an antibiotic adjuvant that permeabilizes the Gram-negative membrane, in combination with rifampin against AB5075, an extensively drug-resistant (XDR) A. baumannii strain. In standard in vitro assays and in a murine pulmonary model, we found that this drug combination can significantly reduce bacterial burden and promote animal survival despite an aggressive infection. Copyright © 2017 Zurawski et al.

Post-pancreatitis Fat Necrosis Mimicking Carcinomatosis.

PubMed

Smith, Joshua P; Arnoletti, J Pablo; Varadarajulu, Shyam; Morgan, Desiree E

2008-01-01

Acute pancreatitis can result in retroperitoneal fat necrosis, typically occurring in the peripancreatic region, with extension into the transverse mesocolon, omentum and mesenteric root. When evaluated with contrast enhanced computed tomography (CECT), acute peripancreatic post necrotic collections typically become lower in attenuation over time, and often appear as homogeneous fluid collections. Saponification as a complication of fat necrosis in patients with acute pancreatitis is a well recognized clinical entity. While retroperitonal fat necrosis is commonly seen on CECT, saponification is not a prominent imaging feature. We present a case of acute pancreatitis complicated by extensive saponification of fat throughout the retroperitoneum and peritoneal lining, mimicking carcinomatosis.

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.

Psychometric Properties of the MMPI-2-RF Somatic Complaints (RC1) Scale

ERIC Educational Resources Information Center

Thomas, Michael L.; Locke, Dona E. C.

2010-01-01

The MMPI-2 Restructured Form (MMPI-2-RF; Tellegen & Ben-Porath, 2008) was designed to be psychometrically superior to its MMPI-2 counterpart. However, the test has yet to be extensively evaluated in diverse clinical settings. The purpose of this study was to examine the psychometric properties of the MMPI-2-RF Somatic Complaints (RC1) scale in…

[Significance and necessity of developing quality of life questionnaire for cancer patients adapting to traditional Chinese medicine].

PubMed

You, Jie

2006-09-01

The clinical evaluation system for therapeutic effects of tumor, which focuses on survival period and tumor response rate, has been proved not very proper for evaluating the therapeutic effects of traditional Chinese medicine (TCM). Quality of life (QOL) has been introduced into the effective evaluation system of TCM and integrative medicine because of its similarity in concept and extension with TCM at theory basis, syndrome differentiation-treatment, and evaluation of therapeutic effects. But there are no QOL questionnaires which can evaluate the therapeutic effects of TCM and integrative medicine precisely. This article discussed the necessity and significance of developing QOL questionnaire special for TCM.

Evaluation of RxNorm for Medication Clinical Decision Support.

PubMed

Freimuth, Robert R; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS.

Evaluation of RxNorm for Medication Clinical Decision Support

PubMed Central

Freimuth, Robert R.; Wix, Kelly; Zhu, Qian; Siska, Mark; Chute, Christopher G.

2014-01-01

We evaluated the potential use of RxNorm to provide standardized representations of generic drug name and route of administration to facilitate management of drug lists for clinical decision support (CDS) rules. We found a clear representation of generic drug name but not route of administration. We identified several issues related to data quality, including erroneous or missing defined relationships, and the use of different concept hierarchies to represent the same drug. More importantly, we found extensive semantic precoordination of orthogonal concepts related to route and dose form, which would complicate the use of RxNorm for drug-based CDS. This study demonstrated that while RxNorm is a valuable resource for the standardization of medications used in clinical practice, additional work is required to enhance the terminology so that it can support expanded use cases, such as managing drug lists for CDS. PMID:25954360

Alternative Medicine and Alzheimer's Disease

PubMed Central

Kelley, Brendan J.; Knopman, David S.

2009-01-01

Background Alternative medicine has an extensive worldwide history and is commonly used by older patients. A number of different alternative medicines are used by patients having Alzheimer's disease. It is both desirable and expected for clinicians to be acquainted with these medications. Review Summary This paper discusses the available clinical trial evidence regarding eight agents commonly used by people having Alzheimer's disease. We provide an overview of the history and basic scientific evidence available for each agent, followed by a critical analysis of the evidence available from clinical trials, including the number of participants, trial duration and specific outcomes evaluated. Conclusion While many of these compounds have been associated with interesting basic science, none has shown clear clinical benefit to date. Data available for some, such as ginkgo biloba, curcumin and huperzine A, suggest that further evaluation is warranted. Familiarity with this literature will allow clinicians to provide meaningful recommendations to patients who wish to use these agents. PMID:18784599

Yoga for Health Care in Korea: A Protocol for Systematic Review of Clinical Trials.

PubMed

Choi, Jiae; Jun, Ji Hee; Lee, Ju Ah; Lee, Myeong Soo

2016-08-01

This systematic review aims to evaluate the therapeutic effects of yoga therapy using an evidence-based approach and investigates the relationship between yoga and the meridian energies based on all available clinical studies in Korea. Sixteen electronic databases will be searched from the inception of the study until January 2016. All clinical evidences that evaluate any type of yoga and any type of control in individuals with any type of condition will be eligible. The methodological quality will be assessed using the Cochrane risk of bias tool for randomized clinical trials and the Newcastle-Ottawa scale for nonrandomized studies. Two authors will independently assess each study for eligibility and the risk of bias, and then they will extract the data. With its extensive, unbiased search of the Korean literature from various databases without any language restrictions, this systematic review will be useful for both practitioners in the field of yoga research as well as for patients. Copyright © 2016. Published by Elsevier B.V.

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

PubMed

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

2015-01-01

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

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

PubMed Central

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

2015-01-01

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

Robotic-arm assisted partial knee arthroplasty: a single centre experience.

PubMed

Marcovigi, Andrea; Zambianchi, Francesco; Sandoni, Dario; Rivi, Elisa; Catani, Fabio

2017-06-07

UKA has proven to be an effective surgical procedure, but its survivorship is still negatively affected by inaccuracy in component component positioning, implant and limb alignment. Robotic surgery has been introduced in order to minimize such technical errors. The aim of the present paper was to evaluate clinical and surgical outcomes after a 3 years' experience of robotic assisted UKA with the Mako Robotic Arm. Seventy-three patients undergoing  UKA with robotic instrumentation (65 medial UKAs, 8 lateral UKAs) and with a clinical follow-up of 3 -37 months were included in the present study. A complete clinical evaluation with KOOS, FJS-12 and SF-12 was administered to all patients pre and post operatively. Post-operative HKA angle and surgical time were also recorded. Mean post-operative KOOS score was 81.32 (SD 17.19), while the mean FJS-12 score was 75.51 (SD 30.12) and the mean SF-12 Physical Score 42.25 (SD 9.97). 91% to 88% of post-operative results were considered satisfactory. Only 1 UKA failure was reported (1.3%) caused by peri-prosthetic infection. In medial UKAs mean postoperative HKA angle in extension was 3.9° varus (SD 2.5°), with no case of overcorrection; in lateral UKAs mean postoperative HKA angle in extension was 1.9° valgus (SD 1.9°) with 1 case (13%) of overcorrection. Mean skin to skin surgical time decreased from 83.2 minutes (SD 13.0) to 70.0 minutes (SD 10.9) along the learning curve. Robotic UKA has provided an improvement both in clinical and technical results, determining satisfactory clinical outcomes and a low risk of post-operative complications.

The role of FDG PET/CT in patients with locoregional breast cancer recurrence: a comparison to conventional imaging techniques.

PubMed

Aukema, T S; Rutgers, E J Th; Vogel, W V; Teertstra, H J; Oldenburg, H S; Vrancken Peeters, M T F D; Wesseling, J; Russell, N S; Valdés Olmos, R A

2010-04-01

The aim of this study was to evaluate the impact of (18)F-fluorodeoxyglucose positron-emission tomography/computed tomography (FDG PET/CT) on clinical management in patients with locoregional breast cancer recurrence amenable for locoregional treatment and to compare the PET/CT results with the conventional imaging data. From January 2006 to August 2008, all patients with locoregional breast cancer recurrence underwent whole-body PET/CT. PET/CT findings were compared with results of the conventional imaging techniques and final pathology. The impact of PET/CT results on clinical management was evaluated based on clinical decisions obtained from patient files. 56 patients were included. In 32 patients (57%) PET/CT revealed additional tumour localisations. Distant metastases were detected in 11 patients on conventional imaging and in 23 patients on PET/CT images (p < 0.01). In 25 patients (45%), PET/CT detected additional lesions not visible on conventional imaging. PET/CT had an impact on clinical management in 27 patients (48%) by detecting more extensive locoregional disease or distant metastases. In 20 patients (36%) extensive surgery was prevented and treatment was changed to palliative treatment. The sensitivity, specificity, accuracy, positive and negative predictive values of FDG PET/CT were respectively 97%, 92%, 95%, 94% and 96%. PET/CT, in addition to conventional imaging techniques, plays an important role in staging patients with locoregional breast cancer recurrence since its result changed the clinical management in almost half of the patients. PET/CT could potentially replace conventional staging imaging in patients with a locoregional breast cancer recurrence. Copyright (c) 2009 Elsevier Ltd. All rights reserved.

Camera-tracking gaming control device for evaluation of active wrist flexion and extension.

PubMed

Shefer Eini, Dalit; Ratzon, Navah Z; Rizzo, Albert A; Yeh, Shih-Ching; Lange, Belinda; Yaffe, Batia; Daich, Alexander; Weiss, Patrice L; Kizony, Rachel

Cross sectional. Measuring wrist range of motion (ROM) is an essential procedure in hand therapy clinics. To test the reliability and validity of a dynamic ROM assessment, the Camera Wrist Tracker (CWT). Wrist flexion and extension ROM of 15 patients with distal radius fractures and 15 matched controls were assessed with the CWT and with a universal goniometer. One-way model intraclass correlation coefficient analysis indicated high test-retest reliability for extension (ICC = 0.92) and moderate reliability for flexion (ICC = 0.49). Standard error for extension was 2.45° and for flexion was 4.07°. Repeated-measures analysis revealed a significant main effect for group; ROM was greater in the control group (F[1, 28] = 47.35; P < .001). The concurrent validity of the CWT was partially supported. The results indicate that the CWT may provide highly reliable scores for dynamic wrist extension ROM, and moderately reliable scores for flexion, in people recovering from a distal radius fracture. N/A. Copyright © 2016 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Using EHR audit trail logs to analyze clinical workflow: A case study from community-based ambulatory clinics.

PubMed

Wu, Danny T Y; Smart, Nikolas; Ciemins, Elizabeth L; Lanham, Holly J; Lindberg, Curt; Zheng, Kai

2017-01-01

To develop a workflow-supported clinical documentation system, it is a critical first step to understand clinical workflow. While Time and Motion studies has been regarded as the gold standard of workflow analysis, this method can be resource consuming and its data may be biased due to the cognitive limitation of human observers. In this study, we aimed to evaluate the feasibility and validity of using EHR audit trail logs to analyze clinical workflow. Specifically, we compared three known workflow changes from our previous study with the corresponding EHR audit trail logs of the study participants. The results showed that EHR audit trail logs can be a valid source for clinical workflow analysis, and can provide an objective view of clinicians' behaviors, multi-dimensional comparisons, and a highly extensible analysis framework.

SU-E-I-17: Evaluation of Commercially Available Extension Plates for the ACR CT Accreditation Phantom

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

Greene-Donnelly, K; Ogden, K

Purpose: To evaluate the impact of commercially available extension plates on Hounsfield Unit (HU) values in the ACR CT accreditation phantom (Model 464, Gammex Inc., Middleton, Wi). The extension plates are intended to improve water HU values in scanners where the traditional solution involves scanning the phantom with an adjacent water or CTDI phantom. Methods: The Model 464 phantom was scanned on 9 different CT scanners at 8 separate sites representing 16 and 64 slice MDCT technology from four CT manufacturers. The phantom was scanned with and without the extension plates (Gammex 464 EXTPLT-KIT) in helical and axial modes. Amore » water phantom was also scanned to verify water HU calibration. Technique was 120 kV tube potential, 350 mAs, and 210 mm display field of view. Slice thickness and reconstruction algorithm were based on site clinical protocols. The widest available beam collimation was used. Regions of interest were drawn on the HU test objects in Module 1 of the phantom and mean values recorded. Results: For all axial mode scans, water HU values were within limits with or without the extension plates. For two scanners (both Lightspeed VCT, GE Medical Systems, Waukesha WI), axial mode bone HU values were above the specified range both with and without the extension plates though they were closer to the specified range with the plates installed. In helical scan mode, two scanners (both GE Lightspeed VCT) had water HU values above the specified range without the plates installed. With the plates installed, the water HU values were within range for all scanners in all scan modes. Conclusion: Using the plates, the Lightspeed VCT scanners passed the water HU test when scanning in helical mode. The benefit of the extension plates was evident in helical mode scanning with GE scanners using a nominal 4 cm beam. Disclosure: The extension plates evaluated in this work were provided free of charge to the authors. The authors have no other financial interest in Gammex Inc.« less

[Research progress of larger flexion gap than extension gap in total knee arthroplasty].

PubMed

Zhang, Weisong; Hao, Dingjun

2017-05-01

To summarize the progress of larger flexion gap than extension gap in total knee arthro-plasty (TKA). The domestic and foreign related literature about larger flexion gap than extension gap in TKA, and its impact factors, biomechanical and kinematic features, and clinical results were summarized. During TKA, to adjust the relations of flexion gap and extension gap is one of the key factors of successful operation. The biomechanical, kinematic, and clinical researches show that properly larger flexion gap than extension gap can improve both the postoperative knee range of motion and the satisfaction of patients, but does not affect the stability of the knee joint. However, there are also contrary findings. So adjustment of flexion gap and extension gap during TKA is still in dispute. Larger flexion gap than extension gap in TKA is a new joint space theory, and long-term clinical efficacy, operation skills, and related complications still need further study.

Platelet-Derived Growth Factor Promotes Periodontal Regeneration in Localized Osseous Defects: 36-Month Extension Results From a Randomized, Controlled, Double-Masked Clinical Trial

PubMed Central

Nevins, Myron; Kao, Richard T.; McGuire, Michael K.; McClain, Pamela K.; Hinrichs, James E.; McAllister, Bradley S.; Reddy, Michael S.; Nevins, Marc L.; Genco, Robert J.; Lynch, Samuel E.; Giannobile, William V.

2017-01-01

Background Recombinant human platelet-derived growth factor (rhPDGF) is safe and effective for the treatment of periodontal defects in short-term studies up to 6 months in duration. We now provide results from a 36-month extension study of a multicenter, randomized, controlled clinical trial evaluating the effect and long-term stability of PDGF-BB treatment in patients with localized severe periodontal osseous defects. Methods A total of 135 participants were enrolled fromsix clinical centers for an extension trial. Eighty-three individuals completed the study at 36 months and were included in the analysis. The study investigated the local application of β-tricalcium phosphate scaffold matrix with or without two different dose levels of PDGF (0.3 or 1.0 mg/mL PDGF-BB) in patients possessing one localized periodontal osseous defect. Composite analysis for clinical and radiographic evidence of treatment success was defined as percentage of cases with clinical attachment level (CAL) ≥2.7mmand linear bone growth (LBG) ≥1.1 mm. Results The participants exceeding this composite outcome benchmark in the 0.3 mg/mL rhPDGF-BB group went from 62.2% at 12 months, 75.9% at 24 months, to 87.0% at 36 months compared with 39.5%, 48.3%, and 53.8%, respectively, in the scaffold control group at these same time points (P <0.05). Although there were no significant increases in CAL and LBG at 36 months among all groups, there were continued increases in CAL gain, LBG, and percentage bone fill over time, suggesting overall stability of the regenerative response. Conclusion PDGF-BB in a synthetic scaffold matrix promotes long-term stable clinical and radiographic improvements as measured by composite outcomes for CAL gain and LBG for patients possessing localized periodontal defects (ClinicalTrials.gov no. CT01530126). PMID:22612364

Recurrent longitudinal extensive transverse myelitis in a neuro-Behçet syndrome treated with infliximab.

PubMed

Uygunoğlu, Uğur; Pasha, Maarya; Saip, Sabahattin; Siva, Aksel

2015-01-01

Spinal cord involvement is not common, but can be seen in neuro-Behçet's syndrome (NBS). The major site of involvement is the cervical spinal cord with the myelitis-like inflammatory lesions continuing more than two segments, and extending to the brainstem. A 30-year-old male patient who has been followed with a diagnosis of Behçet's syndrome admitted to our neurology department clinically and radiologically suggestive of recurrent and extensive longitudinal myelitis. His anti-aquaporine antibody was negative. Because of insufficient effect of azathioprine, cyclophosphamide, and corticosteroids, infliximab was started. His clinical and radiological status is stationary for 3 years under infliximab treatment. Myelitis such as that occurring in our patient may have a similar presentation like neuromyelitis optica (NMO), which should therefore be included in differential diagnosis. Myelitis observed in both NMO and NBS shows spinal cord lesions longer than three or more vertebrae. Anti-aquaporine antibody must be evaluated in all patients presenting with longitudinal myelitis. Anti-tumor necrosis factor agent infliximab might be an alternative treatment in severe form of NBS such as myelitis. In our case, successful treatment of recurrent and extensive longitudinal transverse myelitis in NBS with infliximab was demonstrated.

Integrating teaching into routine outpatient care: The design and evaluation of an ambulatory training concept (HeiSA).

PubMed

Hundertmark, Jan; Apondo, Sandra Karina; Schultz, Jobst-Hendrik

2018-01-01

Background: Direct patient contact is crucial in learning important interactional and examination skills. However, medical students have limited opportunity to self-responsibly practise these skills in authentic clinical settings and typically receive insufficient feedback on their performance. We developed a novel single-session ambulatory teaching concept (Heidelberg Student Ambulatory training, "HeiSA") to prepare students more adequately for clinical-practical responsibilities. Methods: To identify challenges and target group needs, we reviewed current literature and consulted an expert group of faculty lecturers and training researchers. The resulting course concept was put into practice at the University Hospital's general-internistic outpatient department and evaluated in a pilot phase (winter term 2010, ten participants) and a main project phase (summer and winter terms 2011, 14 and 21 participants, respectively). Third and fourth-year students autonomously take a new patient's medical history and conduct a complete physical examination in one hour under supervision, followed by extensive preceptor feedback. To assess learning achievements, participants and a control group self-rated their communication and examination skills before and (participants only) after the session on six-point Likert scales (1=completely able, 6=completely unable). The preceptor also evaluated the participants' performance. Finally, all stakeholders re-evaluated the course concept. Results: HeiSA is a feasible training concept and accepted by staff members and students. It provides opportunities to practise clinical skills in a relevant, authentic learning environment with extensive feedback. Participants report improved anamnesis (0.27±0.51, p =.003) and physical examination (0.25±0.41, p =.008) skills. The preceptor evaluated students' performance to be generally high, with ratings ranging from 1.40±0.55 (item: the student does not interrupt the patient) to 2.51±0.89 (item: psychosocial anamnesis). Conclusions: HeiSA is a viable course concept for teaching anamnesis and physical examination skills. It integrates student teaching into routine care and can potentially be adapted to other outpatient departments.

The integrity of bonded amalgam restorations: a clinical evaluation after five years.

PubMed

Mach, Zbynek; Regent, Jan; Staninec, Michal; Mrklas, Lubor; Setcos, James C

2002-04-01

Bonded amalgam restorations have been studied extensively in vitro, but few long term clinical studies exist. The authors examined the clinical performance of bonded amalgam restorations after five years of clinical service an compared it with that of nonbonded amalgam restorations. The authors placed 75 bonded and 62 nonbonded amalgam restorations in patients needing restorations. Most of the restorations were placed in conventional preparations; six bonded restorations were placed in nonretentive cavities. They were evaluated after a five-year period of clinical service by two trained dentists using a mirror and explorer and following modified U.S. Public Health Service criteria. Statistical analysis (via Fisher exact test) showed no significant differences between the two techniques when conventional preparations were used. Restorations in nonretentive preparations were successful during this period. Bonded and nonbonded amalgam restorations yielded similar results in conventional preparations after five years of clinical service. Bonded amalgam restorations were clinically successful in a limited number of nonretentive preparations over a five-year period. Bonded amalgam restorations can be used successfully in conventional preparations and possibly in nonretentive preparations as well, and can be expected to last at least five years.

IFCN-endorsed practical guidelines for clinical magnetoencephalography (MEG).

PubMed

Hari, Riitta; Baillet, Sylvain; Barnes, Gareth; Burgess, Richard; Forss, Nina; Gross, Joachim; Hämäläinen, Matti; Jensen, Ole; Kakigi, Ryusuke; Mauguière, François; Nakasato, Nobukatzu; Puce, Aina; Romani, Gian-Luca; Schnitzler, Alfons; Taulu, Samu

2018-04-17

Magnetoencephalography (MEG) records weak magnetic fields outside the human head and thereby provides millisecond-accurate information about neuronal currents supporting human brain function. MEG and electroencephalography (EEG) are closely related complementary methods and should be interpreted together whenever possible. This manuscript covers the basic physical and physiological principles of MEG and discusses the main aspects of state-of-the-art MEG data analysis. We provide guidelines for best practices of patient preparation, stimulus presentation, MEG data collection and analysis, as well as for MEG interpretation in routine clinical examinations. In 2017, about 200 whole-scalp MEG devices were in operation worldwide, many of them located in clinical environments. Yet, the established clinical indications for MEG examinations remain few, mainly restricted to the diagnostics of epilepsy and to preoperative functional evaluation of neurosurgical patients. We are confident that the extensive ongoing basic MEG research indicates potential for the evaluation of neurological and psychiatric syndromes, developmental disorders, and the integrity of cortical brain networks after stroke. Basic and clinical research is, thus, paving way for new clinical applications to be identified by an increasing number of practitioners of MEG. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Clinical classification and neuro-vestibular evaluation in chronic dizziness.

PubMed

Oh, Sun-Young; Kim, Do-Hyung; Yang, Tae-Ho; Shin, Byoung-Soo; Jeong, Seul-Ki

2015-01-01

This study attempts to clarify the clinical characteristics of chronic dizziness and its relationships with specific vestibular, oculomotor, autonomic and psychiatric dysfunctions. 73 Patients with idiopathic chronic dizziness were recruited and classified based on history taking and clinical examination into the following four clinical subgroups; vestibular migraine (VM), dysautonomia, psychogenic, and unspecified groups. They were also evaluated using oculomotor, otolithic and autonomic function tests, and psychologic investigation. Patients in the VM group showed a high proportion of abnormality on smooth pursuit and otolithic function testing compared to the other groups. The dysautonomia group revealed significant abnormalities in sympathetic and cardiovagal autonomic function, while the psychogenic group had a high frequency of abnormality in sympathetic autonomic testing and in Beck's anxiety inventory scale. The unspecified group showed abnormalities on saccade, smooth pursuit and autonomic function testing. Clinical classification of patients with chronic dizziness was relevant and they showed a correlation with disease-specific abnormal results in oculomotor, otolithic, autonomic function and psychology testing. Appropriate diagnostic investigation based on precise clinical diagnosis of chronic dizziness reduces the need for extensive laboratory testing, neuroimaging, and other low-yield tests. Copyright © 2014 International Federation of Clinical Neurophysiology. Published by Elsevier Ireland Ltd. All rights reserved.

Clinical evaluation of pacemaker automatic capture management and atrioventricular interval extension algorithm.

PubMed

Chen, Ke-ping; Xu, Geng; Wu, Shulin; Tang, Baopeng; Wang, Li; Zhang, Shu

2013-03-01

The present study was to assess the accuracy of automatic atrial and ventricular capture management (ACM and VCM) in determining pacing threshold and the performance of a second-generation automatic atrioventricular (AV) interval extension algorithm for reducing unnecessary ventricular pacing. A total of 398 patients at 32 centres who received an EnPulse dual-chamber pacing/dual-chamber adaptive rate pacing pacemaker (Medtronic, Minneapolis, MN, USA) were enrolled. The last amplitude thresholds as measured by ACM and VCM prior to the 6-month follow-up were compared with manually measured thresholds. Device diagnostics were used to evaluate ACM and VCM and the percentage of ventricular pacing with and without the AV extension algorithm. Modelling was performed to assess longevity gains relating to the use of automaticity features. Atrial and ventricular capture management performed accurately and reliably provided complete capture management in 97% of studied patients. The AV interval extension algorithm reduced the median per cent of right ventricular pacing in patients with sinus node dysfunction from 99.7 to 1.5% at 6-month follow-up and in patients with intermittent AV block (excluding persistent 3° AV block) from 99.9 to 50.2%. On the basis of validated modelling, estimated device longevity could potentially be extended by 1.9 years through the use of the capture management and AV interval extension features. Both ACM and VCM features reliably measured thresholds in nearly all patients; the AV extension algorithm significantly reduced ventricular pacing; and the use of pacemaker automaticity features potentially extends device longevity.

Extension and flexion in the upper cervical spine in neck pain patients.

PubMed

Ernst, Markus J; Crawford, Rebecca J; Schelldorfer, Sarah; Rausch-Osthoff, Anne-Kathrin; Barbero, Marco; Kool, Jan; Bauer, Christoph M

2015-08-01

Neck pain is a common problem in the general population with high risk of ongoing complaints or relapses. Range of motion (ROM) assessment is scientifically established in the clinical process of diagnosis, prognosis and outcome evaluation in neck pain. Anatomically, the cervical spine (CS) has been considered in two regions, the upper and lower CS. Disorders like cervicogenic headache have been clinically associated with dysfunctions of the upper CS (UCS), yet ROM tests and measurements are typically conducted on the whole CS. A cross-sectional study assessing 19 subjects with non-specific neck pain was undertaken to examine UCS extension-flexion ROM in relation to self-reported disability and pain (via the Neck Disability Index (NDI)). Two measurement devices (goniometer and electromagnetic tracking) were employed and compared. Correlations between ROM and the NDI were stronger for the UCS compared to the CS, with the strongest correlation between UCS flexion and the NDI-headache (r = -0.62). Correlations between UCS and CS ROM were fair to moderate, with the strongest correlation between UCS flexion and CS extension ROM (r = -0.49). UCS flexion restriction is related to headache frequency and intensity. Consistency and agreement between both measurement systems and for all tests was high. The results demonstrate that separate UCS ROM assessments for extension and flexion are useful in patients with neck pain. Copyright © 2014 Elsevier Ltd. All rights reserved.

Clinical evaluation of music perception, appraisal and experience in cochlear implant users.

PubMed

Drennan, Ward R; Oleson, Jacob J; Gfeller, Kate; Crosson, Jillian; Driscoll, Virginia D; Won, Jong Ho; Anderson, Elizabeth S; Rubinstein, Jay T

2015-02-01

The objectives were to evaluate the relationships among music perception, appraisal, and experience in cochlear implant users in multiple clinical settings and to examine the viability of two assessments designed for clinical use. Background questionnaires (IMBQ) were administered by audiologists in 14 clinics in the United States and Canada. The CAMP included tests of pitch-direction discrimination, and melody and timbre recognition. The IMBQ queried users on prior musical involvement, music listening habits pre and post implant, and music appraisals. One-hundred forty-five users of Advanced Bionics and Cochlear Ltd cochlear implants. Performance on pitch direction discrimination, melody recognition, and timbre recognition tests were consistent with previous studies with smaller cohorts, as well as with more extensive protocols conducted in other centers. Relationships between perceptual accuracy and music enjoyment were weak, suggesting that perception and appraisal are relatively independent for CI users. Perceptual abilities as measured by the CAMP had little to no relationship with music appraisals and little relationship with musical experience. The CAMP and IMBQ are feasible for routine clinical use, providing results consistent with previous thorough laboratory-based investigations.

A Randomised, Placebo-Controlled Trial of Neurodynamic Sliders on Hamstring Responses in Footballers with Hamstring Tightness

PubMed Central

Areeudomwong, Pattanasin; Oatyimprai, Ketsarakon; Pathumb, Saranchana

2016-01-01

Background Neurodynamics intervention is known to increase apparent muscle extensibility, but information regarding hamstring responses after a neurodynamic sliders (NS) technique is scarce. The aim of this study was to evaluate the effects of NS on apparent hamstring extensibility and activity in footballers with hamstring tightness. Methods Forty eligible healthy male footballers with hamstring tightness were each randomly allocated to either a 4-week NS technique or a control group (CG) receiving placebo shortwave intervention. Knee extension angles were measured with the passive knee extension test, and maximal voluntary isometric contraction (MVIC) of hamstrings was measured by a surface electromyography at baseline and after intervention sessions. Results The results showed that NS produced a statistically and clinically significant increase in knee extension angle compared to CG (P < 0.001); however, there was no difference between the groups receiving MVIC of hamstrings. Within group comparison, NS also provided a significant increase in knee extension angle (P < 0.001), whereas the control group did not. There was no change in hamstring MVIC in either group after intervention. Conclusions The findings of this study reveal that four weeks of NS technique improved apparent hamstring extensibility but did not change the hamstring activity in footballers with hamstring tightness. PMID:28090180

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.

A design thinking approach to evaluating interprofessional education.

PubMed

Cahn, Peter S; Bzowyckyj, Andrew; Collins, Lauren; Dow, Alan; Goodell, Kristen; Johnson, Alex F; Klocko, David; Knab, Mary; Parker, Kathryn; Reeves, Scott; Zierler, Brenda K

2016-05-01

The complex challenge of evaluating the impact of interprofessional education (IPE) on patient and community health outcomes is well documented. Recently, at the Radcliffe Institute for Advanced Study in the United States, leaders in health professions education met to help generate a direction for future IPE evaluation research. Participants followed the stages of design thinking, a process for human-centred problem solving, to reach consensus on recommendations. The group concluded that future studies should focus on measuring an intermediate step between learning activities and patient outcomes. Specifically, knowing how IPE-prepared students and preceptors influence the organisational culture of a clinical site as well as how the culture of clinical sites influences learners' attitudes about collaborative practice will demonstrate the value of educational interventions. With a mixed methods approach and an appreciation for context, researchers will be able to identify the factors that foster effective collaborative practice and, by extension, promote patient-centred care.

Effectiveness of lurasidone in schizophrenia or schizoaffective patients switched from other antipsychotics: a 6-month, open-label, extension study.

PubMed

Citrome, Leslie; Weiden, Peter J; McEvoy, Joseph P; Correll, Christoph U; Cucchiaro, Josephine; Hsu, Jay; Loebel, Antony

2014-08-01

To evaluate the long-term safety and tolerability of lurasidone in schizophrenia and schizoaffective disorder patients switched to lurasidone. Patients in this multicenter, 6-month open-label, flexible-dose, extension study had completed a core 6-week randomized trial in which clinically stable, but symptomatic, outpatients with schizophrenia or schizoaffective disorder were switched to lurasidone. Patients started the extension study on treatment with the same dose of lurasidone taken at study endpoint of the 6-week core study; following this, lurasidone was flexibly dosed (40-120 mg/day), if clinically indicated, starting on Day 7 of the extension study. The primary safety endpoints were the proportion of patients with treatment emergent adverse events (AEs), serious AEs, or who discontinued due to AEs. Secondary endpoints included metabolic variables and measures of extrapyramidal symptoms and akathisia, as well as the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impressions-Severity (CGI-S), and the Calgary Depression Scale for Schizophrenia (CDSS). The study was conducted from August 2010 to November 2011. Of the 198 patients who completed the 6-week core study, 149 (75.3%) entered the extension study and 148 received study medication. A total of 98 patients (65.8%) completed the 6-month extension study. Lurasidone 40, 80, and 120 mg were the modal daily doses for 19 (12.8%), 65 (43.9%), and 64 (43.2%) of patients, respectively. Overall mean (SD) daily lurasidone dose was 102.0 mg (77.1). The most commonly reported AEs were insomnia (13 patients [8.8%]), nausea (13 patients [8.8%]), akathisia (12 patients [8.1%]), and anxiety (9 patients [6.1%]). A total of 16 patients (10.8%) had at least one AE leading to discontinuation from the study. Consistent with prior studies of lurasidone, there was no signal for clinically relevant adverse changes in body weight, lipids, glucose, insulin, or prolactin. Movement disorder rating scales did not demonstrate meaningful changes. Treatment failure (defined as any occurrence of discontinuation due to insufficient clinical response, exacerbation of underlying disease, or AE) was observed for 19 patients (12.8% of patients entering) and median time to treatment failure was 58 days (95% CI 22-86). The discontinuation rate due to any cause was 50/148 (33.8%), and median time to discontinuation was 62 days (95% CI 30-75). The mean PANSS total score, mean CGI-S score, and mean CDSS score decreased consistently from core study baseline across extension visits, indicating an improvement in overall condition. In this 6-month, open-label extension study, treatment with lurasidone was generally well-tolerated with sustained improvement in efficacy measures observed in outpatients with schizophrenia or schizoaffective disorder who had switched to lurasidone from a broad range of antipsychotic agents.

Modified Direct-Type Septal Extension Grafts: Their Stability and Usefulness in Asian Rhinoplasty.

PubMed

Han, So-Eun; Han, Kihwan; Choi, Jaehoon; Yun, Tae Bin

2017-03-01

In Asian rhinoplasty, many autogenous cartilage grafts are required for correction of the nasal tip and columella, but the amount has limitations. A modified direct-type septal extension graft, in continuity with the entire caudal border of the septal cartilage with an edge-to-edge coaptation, can effectively and concomitantly correct the nasal tip and columella deformities using a limited amount of septal cartilage graft. The purpose of this study was to evaluate long-term cosmetic outcomes and stability from the modified direct extension grafts. Fifty-seven patients with a follow-up of more than 1 year were enrolled in the study. A total of 11 measurement items were evaluated from basal and right lateral views by photogrammetry using standardized clinical photographic techniques. The overall mean follow-up period was 20.4 months. When comparing the preoperative and postoperative values, the nasal tip projection, nasal bridge length, nasal tip angle, height of nose, and the columellar labial angle increased significantly; additionally, the soft nose width index, width between ac-ac index, nostril axis inclination, columellar length (Rt-Lt), and the alar length (Rt-Lt) decreased significantly. No resorption, buckling, or displacement of the graft was observed during the follow-up period. The modified direct extension graft demonstrated a marked aesthetic improvement in the nasal tip and columella, and it provided long-term stability. Therefore, the modified direct extension graft is useful for correction of the nasal tip and columella in Asian rhinoplasty.

Completion of a Hospital-Wide Comprehensive Image Management and Communication System

NASA Astrophysics Data System (ADS)

Mun, Seong K.; Benson, Harold R.; Horii, Steven C.; Elliott, Larry P.; Lo, Shih-Chung B.; Levine, Betty A.; Braudes, Robert E.; Plumlee, Gabriel S.; Garra, Brian S.; Schellinger, Dieter; Majors, Bruce; Goeringer, Fred; Kerlin, Barbara D.; Cerva, John R.; Ingeholm, Mary-Lou; Gore, Tim

1989-05-01

A comprehensive image management and communication (IMAC) network has been installed at Georgetown University Hospital for an extensive clinical evaluation. The network is based on the AT&T CommView system and it includes interfaces to 12 imaging devices, 15 workstations (inside and outside of the radiology department), a teleradiology link to an imaging center, an optical jukebox and a number of advanced image display and processing systems such as Sun workstations, PIXAR, and PIXEL. Details of network configuration and its role in the evaluation project are discussed.

Secondary hypertension, issues in diagnosis and treatment.

PubMed

Pullalarevu, Raghavesh; Akbar, Ghulam; Teehan, Geoffrey

2014-12-01

Secondary hypertension (SH) often implies a correctable form of nonessential hypertension. Often certain clinical clues prompt a more extensive evaluation of the causes of the hypertension. Renovascular disease, intrinsic renal disease, primary hyperaldosteronism, and obstructive sleep apnea represent the most common causes of SH. This article defines the disorder and details its epidemiology, prevalence, pathophysiology, physical findings, and treatment strategies. Copyright © 2014 Elsevier Inc. All rights reserved.

Annual Research Progress Report (U.S. Army Institute of Surgical Research)

DTIC Science & Technology

1979-09-30

have proven effective clinically (2). Additionally, the model remains the standard for evaluating Pseudomonas vaccines , toxoids (3), parenteral...infusion while five others received a 8.5% crystalline amino acid solution. Liver cork bore biopsies were obtained in selected animals and hepatocyte...been used extensively at this Institute and elsewhere to investigate antimicrobial chemo- therapies (18), vaccines (16) and trauma-associated metabolic

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed

Gadd, C S; Baskaran, P; Lobach, D F

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings.

Validation of the Leap Motion Controller using markered motion capture technology.

PubMed

Smeragliuolo, Anna H; Hill, N Jeremy; Disla, Luis; Putrino, David

2016-06-14

The Leap Motion Controller (LMC) is a low-cost, markerless motion capture device that tracks hand, wrist and forearm position. Integration of this technology into healthcare applications has begun to occur rapidly, making validation of the LMC׳s data output an important research goal. Here, we perform a detailed evaluation of the kinematic data output from the LMC, and validate this output against gold-standard, markered motion capture technology. We instructed subjects to perform three clinically-relevant wrist (flexion/extension, radial/ulnar deviation) and forearm (pronation/supination) movements. The movements were simultaneously tracked using both the LMC and a marker-based motion capture system from Motion Analysis Corporation (MAC). Adjusting for known inconsistencies in the LMC sampling frequency, we compared simultaneously acquired LMC and MAC data by performing Pearson׳s correlation (r) and root mean square error (RMSE). Wrist flexion/extension and radial/ulnar deviation showed good overall agreement (r=0.95; RMSE=11.6°, and r=0.92; RMSE=12.4°, respectively) with the MAC system. However, when tracking forearm pronation/supination, there were serious inconsistencies in reported joint angles (r=0.79; RMSE=38.4°). Hand posture significantly influenced the quality of wrist deviation (P<0.005) and forearm supination/pronation (P<0.001), but not wrist flexion/extension (P=0.29). We conclude that the LMC is capable of providing data that are clinically meaningful for wrist flexion/extension, and perhaps wrist deviation. It cannot yet return clinically meaningful data for measuring forearm pronation/supination. Future studies should continue to validate the LMC as updated versions of their software are developed. Copyright © 2016 Elsevier Ltd. All rights reserved.

Self-administered Gerocognitive Examination (SAGE): a brief cognitive assessment Instrument for mild cognitive impairment (MCI) and early dementia.

PubMed

Scharre, Douglas W; Chang, Shu-Ing; Murden, Robert A; Lamb, James; Beversdorf, David Q; Kataki, Maria; Nagaraja, Haikady N; Bornstein, Robert A

2010-01-01

To develop a self-administered cognitive assessment instrument to facilitate the screening of mild cognitive impairment (MCI) and early dementia and determine its association with gold standard clinical assessments including neuropsychologic evaluation. Adults aged above 59 years with sufficient vision and English literacy were recruited from geriatric and memory disorder clinics, educational talks, independent living facilities, senior centers, and memory screens. After Self-administered Gerocognitive Examination (SAGE) screening, subjects were randomly selected to complete a clinical evaluation, neurologic examination, neuropsychologic battery, functional assessment, and mini-mental state examination (MMSE). Subjects were identified as dementia, MCI, or normal based on standard clinical criteria and neuropsychologic testing. Two hundred fifty-four participants took the SAGE screen and 63 subjects completed the extensive evaluation (21 normal, 21 MCI, and 21 dementia subjects). Spearman rank correlation between SAGE and neuropsychologic battery was 0.84 (0.76 for MMSE). SAGE receiver operating characteristics on the basis of clinical diagnosis showed 95% specificity (90% for MMSE) and 79% sensitivity (71% for MMSE) in detecting those with cognitive impairment from normal subjects. This study suggests that SAGE is a reliable instrument for detecting cognitive impairment and compares favorably with the MMSE. The self-administered feature may promote cognitive testing by busy clinicians prompting earlier diagnosis and treatment.

Evaluation of complementary-alternative medicine (CAM) questionnaire development for Indonesian clinical psychologists: A pilot study.

PubMed

Liem, Andrian; Newcombe, Peter A; Pohlman, Annie

2017-08-01

This study aimed to evaluate questionnaire development to measure the knowledge of Complementary-Alternative Medicine (CAM), attitudes towards CAM, CAM experiences, and CAM educational needs of clinical psychologists in Indonesia. A 26-item questionnaire was developed through an extensive literature search. Data was obtained from provisional psychologists from the Master of Professional Clinical Psychology programs at two established public universities in urban areas of Indonesia. To validate the questionnaire, panel reviews by executive members of the Indonesian Clinical Psychology Association (ICPA), experts in health psychology, and experts in public health and CAM provided their professional judgements. The self-reporting questionnaire consisted of four scales including: knowledge of CAM (6 items), attitudes towards CAM (10 items), CAM experiences (4 items), and CAM educational needs (6 items). All scales, except CAM Experiences, were assessed on a 7-point Likert scale. Sixty provisional psychologists were eligible to complete the questionnaire with a response rate of 73% (N=44). The results showed that the CAM questionnaire was reliable (Cronbach's coefficient alpha range=0.62-0.96; item-total correlation range=0.14-0.92) and demonstrated content validity. Following further psychometric evaluation, the CAM questionnaire may provide the evidence-based information to inform the education and practice of Indonesian clinical psychologists. Copyright © 2017 Elsevier Ltd. All rights reserved.

Predictive value of magnetic resonance imaging determined tumor contact length for extracapsular extension of prostate cancer.

PubMed

Baco, Eduard; Rud, Erik; Vlatkovic, Ljiljana; Svindland, Aud; Eggesbø, Heidi B; Hung, Andrew J; Matsugasumi, Toru; Bernhard, Jean-Christophe; Gill, Inderbir S; Ukimura, Osamu

2015-02-01

Tumor contact length is defined as the amount of prostate cancer in contact with the prostatic capsule. We evaluated the ability of magnetic resonance imaging determined tumor contact length to predict microscopic extracapsular extension compared to existing predictors of extracapsular extension. We retrospectively analyzed the records of 111 consecutive patients with magnetic resonance imaging/ultrasound fusion targeted, biopsy proven prostate cancer who underwent radical prostatectomy from January 2010 to July 2013. Median patient age was 64 years and median prostate specific antigen was 8.9 ng/ml. Clinical stage was cT1 in 93 cases (84%) and cT2 in 18 (16%). Postoperative pathological analysis confirmed pT2 in 71 patients (64%) and pT3 in 40 (36%). We evaluated 1) in the radical prostatectomy specimen the correlation of microscopic extracapsular extension with pathological cancer volume, pathological tumor contact length and Gleason score, 2) the correlation between microscopic extracapsular extension and magnetic resonance imaging tumor contact length, and 3) the ability of preoperative variables to predict microscopic extracapsular extension. Logistic regression analysis revealed that pathological tumor contact length correlated better with microscopic extracapsular extension than the predictive power of pathological cancer volume (0.821 vs 0.685). The Spearman correlation between pathological and magnetic resonance imaging tumor contact length was r = 0.839 (p <0.0001). ROC AUC analysis revealed that magnetic resonance imaging tumor contact length outperformed cancer core involvement on targeted biopsy and the Partin tables to predict microscopic extracapsular extension (0.88 vs 0.70 and 0.63, respectively). At a magnetic resonance imaging tumor contact length threshold of 20 mm the accuracy for diagnosing microscopic extracapsular extension was superior to that of conventional magnetic resonance imaging criteria (82% vs 67%, p = 0.015). We developed a predicted probability plot curve of extracapsular extension according to magnetic resonance imaging tumor contact length. Magnetic resonance imaging determined tumor contact length could be a promising quantitative predictor of microscopic extracapsular extension. Copyright © 2015 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

Kernel Regression Estimation of Fiber Orientation Mixtures in Diffusion MRI

PubMed Central

Cabeen, Ryan P.; Bastin, Mark E.; Laidlaw, David H.

2016-01-01

We present and evaluate a method for kernel regression estimation of fiber orientations and associated volume fractions for diffusion MR tractography and population-based atlas construction in clinical imaging studies of brain white matter. This is a model-based image processing technique in which representative fiber models are estimated from collections of component fiber models in model-valued image data. This extends prior work in nonparametric image processing and multi-compartment processing to provide computational tools for image interpolation, smoothing, and fusion with fiber orientation mixtures. In contrast to related work on multi-compartment processing, this approach is based on directional measures of divergence and includes data-adaptive extensions for model selection and bilateral filtering. This is useful for reconstructing complex anatomical features in clinical datasets analyzed with the ball-and-sticks model, and our framework’s data-adaptive extensions are potentially useful for general multi-compartment image processing. We experimentally evaluate our approach with both synthetic data from computational phantoms and in vivo clinical data from human subjects. With synthetic data experiments, we evaluate performance based on errors in fiber orientation, volume fraction, compartment count, and tractography-based connectivity. With in vivo data experiments, we first show improved scan-rescan reproducibility and reliability of quantitative fiber bundle metrics, including mean length, volume, streamline count, and mean volume fraction. We then demonstrate the creation of a multi-fiber tractography atlas from a population of 80 human subjects. In comparison to single tensor atlasing, our multi-fiber atlas shows more complete features of known fiber bundles and includes reconstructions of the lateral projections of the corpus callosum and complex fronto-parietal connections of the superior longitudinal fasciculus I, II, and III. PMID:26691524

The use of transgenic parasites in malaria vaccine research.

PubMed

Othman, Ahmad Syibli; Marin-Mogollon, Catherin; Salman, Ahmed M; Franke-Fayard, Blandine M; Janse, Chris J; Khan, Shahid M

2017-07-01

Transgenic malaria parasites expressing foreign genes, for example fluorescent and luminescent proteins, are used extensively to interrogate parasite biology and host-parasite interactions associated with malaria pathology. Increasingly transgenic parasites are also exploited to advance malaria vaccine development. Areas covered: We review how transgenic malaria parasites are used, in vitro and in vivo, to determine protective efficacy of different antigens and vaccination strategies and to determine immunological correlates of protection. We describe how chimeric rodent parasites expressing P. falciparum or P. vivax antigens are being used to directly evaluate and rank order human malaria vaccines before their advancement to clinical testing. In addition, we describe how transgenic human and rodent parasites are used to develop and evaluate live (genetically) attenuated vaccines. Expert commentary: Transgenic rodent and human malaria parasites are being used to both identify vaccine candidate antigens and to evaluate both sub-unit and whole organism vaccines before they are advanced into clinical testing. Transgenic parasites combined with in vivo pre-clinical testing models (e.g. mice) are used to evaluate vaccine safety, potency and the durability of protection as well as to uncover critical protective immune responses and to refine vaccination strategies.

A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials.

PubMed

Molenberghs, Geert; Burzykowski, Tomasz; Alonso, Ariel; Assam, Pryseley; Tilahun, Abel; Buyse, Marc

2010-06-01

For a number of reasons, surrogate endpoints are considered instead of the so-called true endpoint in clinical studies, especially when such endpoints can be measured earlier, and/or with less burden for patient and experimenter. Surrogate endpoints may occur more frequently than their standard counterparts. For these reasons, it is not surprising that the use of surrogate endpoints in clinical practice is increasing. Building on the seminal work of Prentice(1) and Freedman et al.,(2) Buyse et al. (3) framed the evaluation exercise within a meta-analytic setting, in an effort to overcome difficulties that necessarily surround evaluation efforts based on a single trial. In this article, we review the meta-analytic approach for continuous outcomes, discuss extensions to non-normal and longitudinal settings, as well as proposals to unify the somewhat disparate collection of validation measures currently on the market. Implications for design and for predicting the effect of treatment in a new trial, based on the surrogate, are discussed. A case study in schizophrenia is analysed.

Sexual assault documentation program.

PubMed

Willoughby, Vickie; Heger, Astrid; Rogers, Christopher; Sathyavagiswaran, Lakshmanan

2012-03-01

Since 2001, the Los Angeles County Department of Coroner has collaborated with Los Angeles County-University of Southern California Medical Center Violence Intervention Program and their Sexual Assault Center. The partnership was established at the suggestion of the district attorney's office to enhance the clinical recognition of sexual assault in the medical examiner's office using the extensive experience of experts in the field of sexual assault. As of December 2008, over 5 dozen victims of sexual assault have been evaluated with this collaboration. The partnership relied on the expertise of 2 pediatricians who are established clinical experts in the field of sexual abuse and assault, in collaboration with the staff of the medical examiner's office. In cases of suspected sexual assault, a joint evaluation by the clinical experts and the medical examiner was made. The goal of the project was for the medical examiners to become more confident in their observations and documentation of crimes of sexual abuse. Even though they are still available upon request, consultations with the sexual assault experts have decreased as the skills of the medical examiner to evaluate sexual assault cases have increased.

A National Perspective on the Current Evaluation Activities in Extension

ERIC Educational Resources Information Center

Lamm, Alexa J.; Israel, Glenn D.; Diehl, David

2013-01-01

In order to enhance Extension evaluation efforts it is important to understand current practices. The study reported here researched the evaluation behaviors of county-based Extension professionals. Extension professionals from eight states (n = 1,173) responded to a survey regarding their evaluation data collection, analysis, and reporting…

Application of an assay Cascade methodology for a deep preclinical characterization of polymeric nanoparticles as a treatment for gliomas.

PubMed

Fornaguera, Cristina; Lázaro, Miguel Ángel; Brugada-Vilà, Pau; Porcar, Irene; Morera, Ingrid; Guerra-Rebollo, Marta; Garrido, Cristina; Rubio, Núria; Blanco, Jerónimo; Cascante, Anna; Borrós, Salvador

2018-11-01

Glioblastoma multiforme (GBM) is the most devastating primary brain tumor due to its infiltrating and diffuse growth characteristics, a situation compounded by the lack of effective treatments. Currently, many efforts are being devoted to find novel formulations to treat this disease, specifically in the nanomedicine field. However, due to the lack of comprehensive characterization that leads to insufficient data on reproducibility, only a reduced number of nanomedicines have reached clinical phases. In this context, the aim of the present study was to use a cascade of assays that evaluate from physical-chemical and structural properties to biological characteristics, both in vitro and in vivo, and also to check the performance of nanoparticles for glioma therapy. An amphiphilic block copolymer, composed of polyester and poly(ethylene glycol; PEG) blocks, has been synthesized. Using a mixture of this copolymer and a polymer containing an active targeting moiety to the Blood Brain Barrier (BBB; Seq12 peptide), biocompatible and biodegradable polymeric nanoparticles have been prepared and extensively characterized. In vitro studies demonstrated that nanoparticles are safe for normal cells but cytotoxic for cancer cells. In vivo studies in mice demonstrated the ability of the Seq12 peptide to cross the BBB. Finally, in vivo efficacy studies using a human tumor model in SCID mice resulted in a significant 50% life-span increase, as compared with non-treated animals. Altogether, this assay cascade provided extensive pre-clinical characterization of our polymeric nanoparticles, now ready for clinical evaluation.

Harmonized clinical trial methodologies for localized cutaneous leishmaniasis and potential for extensive network with capacities for clinical evaluation

PubMed Central

Grogl, Max; Boni, Marina; Carvalho, Edgar M.; Chebli, Houda; Cisse, Mamoudou; Diro, Ermias; Fernandes Cota, Gláucia; Erber, Astrid C.; Gadisa, Endalamaw; Handjani, Farhad; Khamesipour, Ali; Llanos-Cuentas, Alejandro; López Carvajal, Liliana; Grout, Lise; Lmimouni, Badre Eddine; Mokni, Mourad; Nahzat, Mohammad Sami; Ben Salah, Afif; Ozbel, Yusuf; Pascale, Juan Miguel; Rizzo Molina, Nidia; Rode, Joelle; Romero, Gustavo; Ruiz-Postigo, José Antonio; Gore Saravia, Nancy; Soto, Jaime; Uzun, Soner; Mashayekhi, Vahid; Vélez, Ivan Dario; Vogt, Florian; Zerpa, Olga; Arana, Byron

2018-01-01

Introduction Progress with the treatment of cutaneous leishmaniasis (CL) has been hampered by inconsistent methodologies used to assess treatment effects. A sizable number of trials conducted over the years has generated only weak evidence backing current treatment recommendations, as shown by systematic reviews on old-world and new-world CL (OWCL and NWCL). Materials and methods Using a previously published guidance paper on CL treatment trial methodology as the reference, consensus was sought on key parameters including core eligibility and outcome measures, among OWCL (7 countries, 10 trial sites) and NWCL (7 countries, 11 trial sites) during two separate meetings. Results Findings and level of consensus within and between OWCL and NWCL sites are presented and discussed. In addition, CL trial site characteristics and capacities are summarized. Conclusions The consensus reached allows standardization of future clinical research across OWCL and NWCL sites. We encourage CL researchers to adopt and adapt as required the proposed parameters and outcomes in their future trials and provide feedback on their experience. The expertise afforded between the two sets of clinical sites provides the basis for a powerful consortium with potential for extensive, standardized assessment of interventions for CL and faster approval of candidate treatments. PMID:29329311

Clinical features and sera anti-aquaporin 4 antibody positivity in patients with demyelinating disorders of the central nervous system from Tianjin, China.

PubMed

Yang, Chun-Sheng; Zhang, Da-Qi; Wang, Jing-Hua; Jin, Wei-Na; Li, Min-Shu; Liu, Jie; Zhang, Cun-Jin; Li, Ting; Shi, Fu-Dong; Yang, Li

2014-01-01

To investigate the clinical characteristics and sera anti-aquaporin 4 (AQP4) antibody positivity in patients with inflammatory demyelinating disorders (IDDs) of the central nervous system (CNS) in Tianjin, China. We retrospectively evaluated 234 patients with IDDs including neuromyelitis optica (NMO), recurrent optic neuritis (rON), longitudinally extensive transverse myelitis (LETM), clinically isolated syndrome (CIS), and multiple sclerosis (MS) groups. Sera from 217 patients were determined for AQP4-Ab. The clinical characteristics and sera anti-AQP4 positivity were compared. The IDDS comprised 63 MS, 51 NMO, 56 LETM, 10 rON, and 54 CIS. Compared with MS, NMO had a higher frequency of occurrence in women, intractable hiccup and nausea (IHN), medullospinal lesion, longitudinally extensive spinal cord lesions (LESCL) and bilateral ON, disease onset at a later age, and worsening residual disability. AQP4-Ab-positive rates were 84.1% and 69% in NMO and NMO spectrum disorders (NMOSD), respectively, whereas it was undetectable in all of the MS sera samples. We comprehensively contrast the distinct clinical features of MS, NMO, and NMOSD in our center. A sensitive AQP4-Ab assay is necessary for the early diagnosis of NMOSD in our patients. Neither medullospinal lesion nor IHN is unique in NMO. © 2013 John Wiley & Sons Ltd.

Concepts in local treatment of extensive paediatric burns.

PubMed

Ungureanu, M

2014-06-15

There is a wide variety of local therapeutical methods for extensive burns. This article aims to be a general overview of the most common methods used in the local treatment for extensive burns, both in our clinic and globally. Clinical examples are shown from our clinic; cases of the last 8 years. None of the less there is no such thing as the "perfect method of treatment" but a thin balance between the clinical experience of plastic surgeons, every case particularities and specified characteristics, meaning advantages, disadvantages and limited indications of local topics or methods of skin covering.

Concepts in local treatment of extensive paediatric burns

PubMed Central

Ungureanu, M

2014-01-01

Abstract There is a wide variety of local therapeutical methods for extensive burns. This article aims to be a general overview of the most common methods used in the local treatment for extensive burns, both in our clinic and globally. Clinical examples are shown from our clinic; cases of the last 8 years. None of the less there is no such thing as the "perfect method of treatment" but a thin balance between the clinical experience of plastic surgeons, every case particularities and specified characteristics, meaning advantages, disadvantages and limited indications of local topics or methods of skin covering. PMID:25408723

Extensive keratinized tissue augmentation during implant rehabilitation after Le Fort I osteotomy: using a new porcine collagen membrane (Mucoderm).

PubMed

Nocini, Pier Francesco; Castellani, Roberto; Zanotti, Guglielmo; Gelpi, Federico; Covani, Ugo; Marconcini, Simone; de Santis, Daniele

2014-05-01

The aim of this study was to test a new collagen matrix (Mucoderm) positioned during oral implant abutment connection. A patient previously treated with Le Fort I for bone augmentation and 8 implants showing minimal amount of keratinized tissue was selected for an extensive keratinized tissue augmentation and deepening of the oral vestibule by apically positioning a split palatal flap and palatal grafting with Mucoderm. Clinical data at 9 and 14 days and 1 and 2 months showed resorption of the collagen graft, augmentation of the keratinized tissue around the implants, and deepening of the vestibule, with minimal morbidity and reduced surgical treatment time. However, some vestibular keratinized tissue contraction was evident. The new collagen matrix may be a promising material as a substitute for an autologous gingival/connective tissue graft. Despite the preliminary results of this innovative article, before drawing any general conclusion, the benefit of the procedure should be further evaluated by prospective clinical trials.

Application of a motivation-behavioral skills protocol in gingival lichen planus: a short-term study.

PubMed

López-Jornet, Pia; Camacho-Alonso, Fabio

2010-10-01

The main objective of the present study was to assess the efficacy of a motivation–behavioral skills protocol for plaque control in patients with gingival lichen planus. A pre- and post-test descriptive clinical study was made of 40 consecutive white patients with gingival lichen planus: five males (12.5%) and 35 females (87.5%); mean age: 57 years. A motivation–behavioral skills protocol for oral hygiene was applied, with the determination of gingival scores (gingival index, plaque extension, and Community Periodontal Index of Treatment Needs [CPITN]) and patient evaluation after 4 and 8 weeks. The clinical parameters in relation to the different forms of gingival lichen planus showed statistically significant improvements for gingival index, plaque extension, and CPITN (P <0.001) as determined 4 and 8 weeks after starting the program. The application of an active prevention program in patients with gingival lichen planus is important because it offers benefits for periodontal health. However, more long-term studies are needed to confirm the results obtained.

Does change in isolated lumbar extensor muscle function correlate with good clinical outcome? A secondary analysis of data on change in isolated lumbar extension strength, pain, and disability in chronic low back pain.

PubMed

Steele, James; Fisher, James; Perrin, Craig; Conway, Rebecca; Bruce-Low, Stewart; Smith, Dave

2018-01-12

Secondary analysis of data from studies utilising isolated lumbar extension exercise interventions for correlations among changes in isolated lumbar extension strength, pain, and disability. Studies reporting isolated lumbar extension strength changes were examined for inclusion criteria including: (1) participants with chronic low back pain, (2) intervention ≥ four weeks including isolated lumbar extension exercise, (3) outcome measures including isolated lumbar extension strength, pain (Visual Analogue Scale), and disability (Oswestry Disability Index). Six studies encompassing 281 participants were included. Correlations among change in isolated lumbar extension strength, pain, and disability. Participants were grouped as "met" or "not met" based on minimal clinically important changes and between groups comparisons conducted. Isolated lumbar extension strength and Visual Analogue Scale pooled analysis showed significant weak to moderate correlations (r = -0.391 to -0.539, all p < 0.001). Isolated lumbar extension strength and Oswestry Disability Index pooled analysis showed significant weak correlations (r = -0.349 to -0.470, all p < 0.001). For pain and disability, isolated lumbar extension strength changes were greater for those "met" compared with those "not met" (p < 0.001-0.008). Improvements in isolated lumbar extension strength may be related to positive and meaningful clinical outcomes. As many other performance outcomes and clinical outcomes are not related, isolated lumbar extension strength change may be a mechanism of action affecting symptom improvement. Implications for Rehabilitation Chronic low back pain is often associated with deconditioning of the lumbar extensor musculature. Isolated lumbar extension exercise has been shown to condition this musculature and also reduce pain and disability. This study shows significant correlations between increases in isolated lumbar extension strength and reductions in pain and disability. Strengthening of the lumbar extensor musculature could be considered an important target for exercise interventions.

Cultured allogenic keratinocytes for extensive burns: a retrospective study over 15 years.

PubMed

Auxenfans, Celine; Shipkov, Hristo; Bach, Christine; Catherine, Zulma; Lacroix, Pierre; Bertin-Maghit, Marc; Damour, Odile; Braye, Fabienne

2014-02-01

The aim was to review the use and indications of cultured allogenic keratinocytes (CAlloK) in extensive burns and their efficiency. This retrospective study comprised 15 years (1997-2012). all patients who received CAlloK. patients who died before complete healing. Evaluation criteria were clinical. Time and success of wound healing after CAlloK use were evaluated. The CAlloK were used for 2 indications - STSG donor sites and deep 2nd degree burns in extensively burned patients. A total of 70 patients were included with severity Baux score of 99.2 (from 51 to 144) and mean percentage of TBSA of 63.49% (from 21 to 96%). Fifty nine patients received CAlloK for STSG donor sites with a mean number of applications of 4 and mean surface of 3800 cm(2) per patient. Treated donor sites were re-harvested 2.5 times. The mean time of complete epithelialization was 7 days. In 11 patients, CAlloK were used for deep 2nd degree burns. The mean percentage of burned surface was 73.7%. The mean surface of CAlloK per patient was 2545 cm(2). Complete healing was achieved in 6.4 days. The CAlloK allow rapid healing of STSG donor-sites and deep 2nd second degree burns in extensively burned patients. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

Changing the Culture of Clinical Education in Massage Therapy

PubMed Central

Baskwill, Amanda

2011-01-01

Much within the profession of massage therapy is done according to tradition. From an epistemological viewpoint, tradition is a way of knowing or, by extension, being, that is based upon both tenacity and authority and not always in best practices. As the profession of massage therapy moves in the direction of evidence-based medicine, or evidence-informed practice, the opportunity to re-evaluate massage therapy education presents itself. PMID:22211155

Changing the culture of clinical education in massage therapy.

PubMed

Baskwill, Amanda

2011-01-01

Much within the profession of massage therapy is done according to tradition. From an epistemological viewpoint, tradition is a way of knowing or, by extension, being, that is based upon both tenacity and authority and not always in best practices. As the profession of massage therapy moves in the direction of evidence-based medicine, or evidence-informed practice, the opportunity to re-evaluate massage therapy education presents itself.

Coexistence of chronic lymphocytic thyroiditis with papillary thyroid carcinoma: clinical manifestation and prognostic outcome.

PubMed

Jeong, Jun Soo; Kim, Hyun Ki; Lee, Cho-Rok; Park, Seulkee; Park, Jae Hyun; Kang, Sang-Wook; Jeong, Jong Ju; Nam, Kee-Hyun; Chung, Woong Youn; Park, Cheong Soo

2012-08-01

The study aimed to identify the clinical characteristics of coexisting chronic lymphocytic thyroiditis (CLT) in papillary thyroid carcinoma (PTC) and to evaluate the influence on prognosis. A total of 1,357 patients who underwent thyroid surgery for PTC were included. The clinicopathological characteristics were identified. Patients who underwent total thyroidectomy (n = 597) were studied to evaluate the influence of coexistent CLT on prognosis. Among the total 1,357 patients, 359 (26.5%) had coexistent CLT. In the CLT group, the prevalence of females was higher than in the control group without CLT (P < 0.001). Mean tumor size and mean age in the patients with CLT were smaller than without CLT (P = 0.040, P = 0.047, respectively). Extrathyroidal extension in the patients with CLT was significantly lower than without CLT (P = 0.016). Among the subset of 597 patients, disease-free survival rate in the patients with CLT was significantly higher than without CLT (P = 0.042). However, the multivariate analysis did not reveal a negative association between CLT coexistence and recurrence. Patients with CLT display a greater female preponderance, smaller size, younger and lower extrathyroidal extension. CLT is not a significant independent negative predictive factor for recurrence, although presence of CLT indicates a reduced risk of recurrence.

Coexistence of Chronic Lymphocytic Thyroiditis with Papillary Thyroid Carcinoma: Clinical Manifestation and Prognostic Outcome

PubMed Central

Jeong, Jun Soo; Kim, Hyun Ki; Lee, Cho-Rok; Park, Seulkee; Park, Jae Hyun; Kang, Sang-Wook; Nam, Kee-Hyun; Chung, Woong Youn; Park, Cheong Soo

2012-01-01

The study aimed to identify the clinical characteristics of coexisting chronic lymphocytic thyroiditis (CLT) in papillary thyroid carcinoma (PTC) and to evaluate the influence on prognosis. A total of 1,357 patients who underwent thyroid surgery for PTC were included. The clinicopathological characteristics were identified. Patients who underwent total thyroidectomy (n = 597) were studied to evaluate the influence of coexistent CLT on prognosis. Among the total 1,357 patients, 359 (26.5%) had coexistent CLT. In the CLT group, the prevalence of females was higher than in the control group without CLT (P < 0.001). Mean tumor size and mean age in the patients with CLT were smaller than without CLT (P = 0.040, P = 0.047, respectively). Extrathyroidal extension in the patients with CLT was significantly lower than without CLT (P = 0.016). Among the subset of 597 patients, disease-free survival rate in the patients with CLT was significantly higher than without CLT (P = 0.042). However, the multivariate analysis did not reveal a negative association between CLT coexistence and recurrence. Patients with CLT display a greater female preponderance, smaller size, younger and lower extrathyroidal extension. CLT is not a significant independent negative predictive factor for recurrence, although presence of CLT indicates a reduced risk of recurrence. PMID:22876054

Clinical map document based on XML (cMDX): document architecture with mapping feature for reporting and analysing prostate cancer in radical prostatectomy specimens.

PubMed

Eminaga, Okyaz; Hinkelammert, Reemt; Semjonow, Axel; Neumann, Joerg; Abbas, Mahmoud; Koepke, Thomas; Bettendorf, Olaf; Eltze, Elke; Dugas, Martin

2010-11-15

The pathology report of radical prostatectomy specimens plays an important role in clinical decisions and the prognostic evaluation in Prostate Cancer (PCa). The anatomical schema is a helpful tool to document PCa extension for clinical and research purposes. To achieve electronic documentation and analysis, an appropriate documentation model for anatomical schemas is needed. For this purpose we developed cMDX. The document architecture of cMDX was designed according to Open Packaging Conventions by separating the whole data into template data and patient data. Analogue custom XML elements were considered to harmonize the graphical representation (e.g. tumour extension) with the textual data (e.g. histological patterns). The graphical documentation was based on the four-layer visualization model that forms the interaction between different custom XML elements. Sensible personal data were encrypted with a 256-bit cryptographic algorithm to avoid misuse. In order to assess the clinical value, we retrospectively analysed the tumour extension in 255 patients after radical prostatectomy. The pathology report with cMDX can represent pathological findings of the prostate in schematic styles. Such reports can be integrated into the hospital information system. "cMDX" documents can be converted into different data formats like text, graphics and PDF. Supplementary tools like cMDX Editor and an analyser tool were implemented. The graphical analysis of 255 prostatectomy specimens showed that PCa were mostly localized in the peripheral zone (Mean: 73% ± 25). 54% of PCa showed a multifocal growth pattern. cMDX can be used for routine histopathological reporting of radical prostatectomy specimens and provide data for scientific analysis.

Clinical map document based on XML (cMDX): document architecture with mapping feature for reporting and analysing prostate cancer in radical prostatectomy specimens

PubMed Central

2010-01-01

Background The pathology report of radical prostatectomy specimens plays an important role in clinical decisions and the prognostic evaluation in Prostate Cancer (PCa). The anatomical schema is a helpful tool to document PCa extension for clinical and research purposes. To achieve electronic documentation and analysis, an appropriate documentation model for anatomical schemas is needed. For this purpose we developed cMDX. Methods The document architecture of cMDX was designed according to Open Packaging Conventions by separating the whole data into template data and patient data. Analogue custom XML elements were considered to harmonize the graphical representation (e.g. tumour extension) with the textual data (e.g. histological patterns). The graphical documentation was based on the four-layer visualization model that forms the interaction between different custom XML elements. Sensible personal data were encrypted with a 256-bit cryptographic algorithm to avoid misuse. In order to assess the clinical value, we retrospectively analysed the tumour extension in 255 patients after radical prostatectomy. Results The pathology report with cMDX can represent pathological findings of the prostate in schematic styles. Such reports can be integrated into the hospital information system. "cMDX" documents can be converted into different data formats like text, graphics and PDF. Supplementary tools like cMDX Editor and an analyser tool were implemented. The graphical analysis of 255 prostatectomy specimens showed that PCa were mostly localized in the peripheral zone (Mean: 73% ± 25). 54% of PCa showed a multifocal growth pattern. Conclusions cMDX can be used for routine histopathological reporting of radical prostatectomy specimens and provide data for scientific analysis. PMID:21078179

["Pericarditis epistenocardica" as as a marker of extensive myocardial infarction. Clinical, electrocardiographic and enzymatic study (author's transl)].

PubMed

Oddone, A; Tommasini, G; Cobelli, F; Birolli, M; Orlandi, M

1977-08-01

Pericarditis may complicate the early phase of myocardial infarction (MI). It occurs when necrosis involves the epicardial surface. To verify if pericarditis may be regarded as a marker of extensive MI, 60 patients with anterior or inferior MI admitted to the Coronary Care Unit within 6 hours from onset of symptoms, were studied by clinical, electrocardiographic and enzymatic parameters. 20 patients developed left ventricular failure (LVF) assessed by clinical, radiologic and hemodynamic indexes (15 mmHg has been considered the upper normal value for mean wedge pulmonary pressure). 9 of the 11 patients with pericarditis (PP) had LVF, versus 11 of the 49 non PP group (P = 0.002). Life threatening arrhythmias (ventricular tachicardia and fibrillation) appeared in 5 of the 11 PP versus 7 of the 49 non PP group (P = 0.04). No significant difference has been found between the two groups concerning the inhospital mortality. In a follow-up of 3 to 18 months, no difference in mortality was observed, while the functional recovery in the PP group was significantly worse (I and II versus III and IV New York Heart Association classes P = 0.003). Higher sigmaST values were found in precordial maps of the PP group, on admission (P = 0.03). After a deep spontaneous fall, sigmaST showed a reelevation which was similar in the two groups. SigmaR showed a greater % decrease however not statistically significant in PP. Creatinekinase enzymatic infarct size was significantly higher in PP group (P = 0.0002). It is concluded that pericarditis is a clinical marker of extensive MI and may be useful in evaluating prognosis and effectiveness of therapeutic interventions in MI.

Approaches to veterinary education--tracking versus a final year broad clinical experience. Part one: effects on career outcome.

PubMed

Klosterman, E S; Kass, P H; Walsh, D A

2009-08-01

This is the first of two papers that provide extensive data and analysis on the two major approaches to clinical veterinary education, which either provide students with experience of a broad range of species (often defined as omni/general clinical competence), or just a few species (sometimes just one), usually termed 'tracking'. Together the two papers provide a detailed analysis of these two approaches for the first time. The responsibilities of veterinary medicine and veterinary education are rapidly increasing throughoutthe globe. It is critical for all in veterinary education to reassess the approaches that have been used, and evaluate on a school-by-school basis which may best meet its expanding and ever-deepening responsibilities.

Recurrent longitudinal extensive transverse myelitis in a neuro-Behçet syndrome treated with infliximab

PubMed Central

Uygunoğlu, Uğur; Pasha, Maarya; Saip, Sabahattin; Siva, Aksel

2015-01-01

Background Spinal cord involvement is not common, but can be seen in neuro-Behçet's syndrome (NBS). The major site of involvement is the cervical spinal cord with the myelitis-like inflammatory lesions continuing more than two segments, and extending to the brainstem. Case A 30-year-old male patient who has been followed with a diagnosis of Behçet's syndrome admitted to our neurology department clinically and radiologically suggestive of recurrent and extensive longitudinal myelitis. His anti-aquaporine antibody was negative. Because of insufficient effect of azathioprine, cyclophosphamide, and corticosteroids, infliximab was started. His clinical and radiological status is stationary for 3 years under infliximab treatment. Discussion Myelitis such as that occurring in our patient may have a similar presentation like neuromyelitis optica (NMO), which should therefore be included in differential diagnosis. Myelitis observed in both NMO and NBS shows spinal cord lesions longer than three or more vertebrae. Anti-aquaporine antibody must be evaluated in all patients presenting with longitudinal myelitis. Anti-tumor necrosis factor agent infliximab might be an alternative treatment in severe form of NBS such as myelitis. Conclusion In our case, successful treatment of recurrent and extensive longitudinal transverse myelitis in NBS with infliximab was demonstrated. PMID:24673549

Microglial Activation Correlates with Disease Progression and Upper Motor Neuron Clinical Symptoms in Amyotrophic Lateral Sclerosis

PubMed Central

Brettschneider, Johannes; Toledo, Jon B.; Van Deerlin, Vivianna M.; Elman, Lauren; McCluskey, Leo; Lee, Virginia M.-Y.; Trojanowski, John Q.

2012-01-01

Background/Aims We evaluated clinicopathological correlates of upper motor neuron (UMN) damage in amyotrophic lateral sclerosis (ALS), and analyzed if the presence of the C9ORF72 repeat expansion was associated with alterations in microglial inflammatory activity. Methods Microglial pathology was assessed by IHC with 2 different antibodies (CD68, Iba1), myelin loss by Kluver-Barrera staining and myelin basic protein (MBP) IHC, and axonal loss by neurofilament protein (TA51) IHC, performed on 59 autopsy cases of ALS including 9 cases with C9ORF72 repeat expansion. Results Microglial pathology as depicted by CD68 and Iba1 was significantly more extensive in the corticospinal tract (CST) of ALS cases with a rapid progression of disease. Cases with C9ORF72 repeat expansion showed more extensive microglial pathology in the medulla and motor cortex which persisted after adjusting for disease duration in a logistic regression model. Higher scores on the clinical UMN scale correlated with increasing microglial pathology in the cervical CST. TDP-43 pathology was more extensive in the motor cortex of cases with rapid progression of disease. Conclusions This study demonstrates that microglial pathology in the CST of ALS correlates with disease progression and is linked to severity of UMN deficits. PMID:22720079

A metabolomic evaluation of the phytochemical composition of tomato juices being used in human clinical trials.

PubMed

Cichon, Morgan J; Riedl, Ken M; Schwartz, Steven J

2017-08-01

Juices from the traditional red tomato and a unique tangerine tomato variety are being investigated as health promoting foods in human clinical trials. However, it is unknown how the tangerine and red tomato juices differ in biologically relevant phytochemicals beyond carotenoids. Here liquid-chromatography high-resolution mass spectrometry metabolomics was used to evaluate broadly the similarities and differences in carotenoids and other phytochemicals between red and tangerine tomato juices intended for clinical interventions. This untargeted approach was successful in the rapid detection and extensive characterization of phytochemicals belonging to various compound classes. The tomato juices were found to differ significantly in a number of phytochemicals, including carotenoids, chlorophylls, neutral lipids, and cinnamic acid derivatives. The largest differences were in carotenoids, including lycopene, phytoene, phytofluene, neurosporene, and ζ-carotene. Smaller, but significant, differences were observed in polar phytochemicals, such as chlorogenic acid, hydroxyferulic acid, phloretin-di-C-glycoside, and isopropylmalic acid. Copyright © 2017 Elsevier Ltd. All rights reserved.

OVERSEER: An Expert System Monitor for the Psychiatric Hospital

PubMed Central

Bronzino, Joseph D.; Morelli, Ralph A.; Goethe, John W.

1988-01-01

In order to improve patient care, comply with regulatory guidelines and decrease potential liability, psychiatric hospitals and clinics have been searching for computer systems to monitor the management and treatment of patients. This paper describes OVERSEER: a knowledge based system that monitors the treatment of psychiatric patients in real time. Based on procedures and protocols developed in the psychiatric setting, OVERSEER monitors the clinical database and issues alerts when standard clinical practices are not followed or when laboratory results or other clinical indicators are abnormal. Written in PROLOG, OVERSEER is designed to interface directly with the hospital's database, and, thereby utilizes all available pharmacy and laboratory data. Moreover, unlike the interactive expert systems developed for the psychiatric clinic, OVERSEER does not require extensive data entry by the clinician. Consequently, the chief benefit of OVERSEER's monitoring approach is the unobtrusive manner in which it evaluates treatment and patient responses and provides information regarding patient management.

Morphological size evaluation of the mid-substance insertion areas and the fan-like extension fibers in the femoral ACL footprint.

PubMed

Suruga, Makoto; Horaguchi, Takashi; Iriuchishima, Takanori; Yahagi, Yoshiyuki; Iwama, Genki; Tokuhashi, Yasuaki; Aizawa, Shin

2017-08-01

The purpose of this study was to evaluate the detailed anatomy of the femoral anterior cruciate ligament (ACL) insertion site, with special attention given to the morphology of the mid-substance insertion areas and the fan-like extension fibers. Twenty-three non-paired human cadaver knees were used (7 Males, 16 Females, median age 83, range 69-96). All soft tissues around the knee were resected except the ligaments. The ACL was divided into antero-medial (AM) and postero-lateral (PL) bundles according to the difference in macroscopic tension patterns. The ACL was carefully dissected and two outlines were made of the periphery of each bundle insertion site: those which included and those which excluded the fan-like extension fibers. An accurate lateral view of the femoral condyle was photographed with a digital camera, and the images were downloaded to a personal computer. The area of each bundle, including and excluding the fan-like extension fibers, was measured with Image J software (National Institution of Health). The width and length of the mid-substance insertion sites were also evaluated using same image. The femoral ACL footprint was divided into four regions (mid-substance insertion sites of the AM and PL bundles, and fan-like extensions of the AM and PL bundles). The measured areas of the mid-substance insertion sites of the AM and PL bundles were 35.5 ± 12.5, and 32.4 ± 13.8 mm 2 , respectively. Whole width and length of the mid-substance insertion sites were 5.3 ± 1.4, and 15.5 ± 2.9 mm, respectively. The measured areas of the fan-like extensions of the AM and PL bundles were 27 ± 11.5, and 29.5 ± 12.4 mm 2 , respectively. The femoral ACL footprint was divided into quarters of approximately equal size (mid-substance insertion sites of the AM and PL bundles, and fan-like extensions of the AM and PL bundles). For clinical relevance, to perform highly reproducible anatomical ACL reconstruction, the presence of the fan-like extension fibers should be taken into consideration.

[Reconstruction of the extensor pollicis longus tendon by transposition of the extensor indicis tendon].

PubMed

Loos, A; Kalb, K; Van Schoonhoven, J; Landsleitner Dagger, B

2003-12-01

Rupture of the extensor pollicis longus-tendon (EPL) is a frequent complication after distal radius fractures. Other traumatic and non-traumatic reasons for this tendon lesion are known, including a theory about a disorder in the blood supply to the tendon itself. We examined 40 patients after reconstruction of the EPL-tendon in a mean follow-up time of 30 months. All patients were clinically examined and a DASH questionnaire was answered by all patients. The method to reconstruct the EPL-tendon was the transposition of the extensor indicis-tendon. After the operations the thumb was put in a splint for four weeks in a "hitch-hiker's-position". 31 ruptures of the tendon (77.5 %) were a result of trauma. In 20 of them (50 %) a distal radius fracture had occurred. Clinical examination included measurements of the movement of the thumb- and index-finger joints, the grip strength and the maximal span of the hand. Significant differences were not found. The isolated extension of the index finger was possible in all patients. But it was reduced in ten cases which represent 25 %. Our results were evaluated by the Geldmacher score to evaluate the reconstruction of the EPL-tendon. 20 % excellent, 65 % good, 12.5 % fair and 2.5 % poor results were reached. The Geldmacher score was used critically. We suggest its modification for the evaluation of thumb abduction. The DASH score reached a functional value of ten points which represents a very good result. In conclusion the extensor indicis-transposition is a safe method to reconstruct the EPL-tendon. Its substantial advantage is taking a healthy muscle as the motor, thereby avoiding the risk of using a degenerated muscle in late tendon reconstruction. A powerful extension of the index finger will be maintained by physical education. Generally, the loss of the extension of the index finger is negligible. It does not disturb the patients. But it has to be discussed with the patient before the operation.

Features of intrinsic ganglionated plexi in both atria after extensive pulmonary isolation and their clinical significance after catheter ablation in patients with atrial fibrillation.

PubMed

Kurotobi, Toshiya; Shimada, Yoshihisa; Kino, Naoto; Ito, Kazato; Tonomura, Daisuke; Yano, Kentaro; Tanaka, Chiharu; Yoshida, Masataka; Tsuchida, Takao; Fukumoto, Hitoshi

2015-03-01

The features of intrinsic ganglionated plexi (GP) in both atria after extensive pulmonary vein isolation (PVI) and their clinical implications have not been clarified in patients with atrial fibrillation (AF). The purpose of this study was to assess the features of GP response after extensive PVI and to evaluate the relationship between GP responses and subsequent AF episodes. The study population consisted of 216 consecutive AF patients (104 persistent AF) who underwent an initial ablation. We searched for the GP sites in both atria after an extensive PVI. GP responses were determined in 186 of 216 patients (85.6%). In the left atrium, GP responses were observed around the right inferior GP in 116 of 216 patients (53.7%) and around the left inferior GP in 57 of 216 (26.4%). In the right atrium, GP responses were observed around the posteroseptal area: inside the CS in 64 of 216 patients (29.6%), at the CS ostium in 150 of 216 (69.4%), and in the lower right atrium in 45 of 216 (20.8%). The presence of a positive GP response was an independent risk factor for AF recurrence (hazard ratio 4.04, confidence interval 1.48-11.0) in patients with paroxysmal, but not persistent, AF. The incidence of recurrent atrial tachyarrhythmias in patients with paroxysmal AF with a positive GP response was 51% vs 8% in those without a GP response (P = .002). The presence of GP responses after extensive PVI was significantly associated with increased AF recurrence after ablation in patients with paroxysmal AF. Copyright © 2015 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.

Company observational post-marketing studies: drug risk assessment and drug research in special populations--a study-based analysis.

PubMed

Hasford, J; Lamprecht, T

1998-01-01

Company observational post-marketing studies (COPS) claim to provide essential data about drug risks and effectiveness in special populations not admitted to pre-approval clinical trials. Since COPS are often mainly regarded as a marketing activity, this study-based analysis tries to evaluate the scientific contributions of COPS. Thirty-five COPS were identified by hand-searching through medical journals, writing to pharmaceutical manufacturers and using MEDLINE. Fourteen COPS evaluated cardiovascular drugs, 9 evaluated NSAIDs and 12 evaluated various other indications. Thirty-five COPS listed effectiveness, 31 listed safety and 8 listed patient compliance as principal objectives. Not a single COPS included a control group. Seventeen of 21 evaluable COPS mentioned extensive exclusion criteria similar to those in clinical trials. Median observation time was 8 weeks, too short for chronic diseases and for adverse drug reactions with longer latency periods. One new adverse event was regarded. Global assessments of the outcomes by physicians dominated and were not based on objective clinical findings. None of the studies specified any details concerning the standardisation of observations or quality-control procedures. The current COPS scheme does not contribute significantly to our knowledge of drug safety and the effects in special populations. Despite serious criticism over the past 20 years, the poor quality of COPS compared with dramatic improvements of pre-approval trials - implies a need for detailed guidelines for non-experimental phase IV research, similar to the Good Clinical Practice-Guideline of the European Community.

Clinical evaluation of music perception, appraisal and experience in cochlear implant users

PubMed Central

Drennan, Ward. R.; Oleson, Jacob J.; Gfeller, Kate; Crosson, Jillian; Driscoll, Virginia D.; Won, Jong Ho; Anderson, Elizabeth S.; Rubinstein, Jay T.

2014-01-01

Objectives The objectives were to evaluate the relationships among music perception, appraisal, and experience in cochlear implant users in multiple clinical settings and to examine the viability of two assessments designed for clinical use. Design Background questionnaires (IMBQ) were administered by audiologists in 14 clinics in the United States and Canada. The CAMP included tests of pitch-direction discrimination, and melody and timbre recognition. The IMBQ queried users on prior musical involvement, music listening habits pre and post implant, and music appraisals. Study sample One-hundred forty-five users of Advanced Bionics and Cochlear Ltd cochlear implants. Results Performance on pitch direction discrimination, melody recognition, and timbre recognition tests were consistent with previous studies with smaller cohorts, as well as with more extensive protocols conducted in other centers. Relationships between perceptual accuracy and music enjoyment were weak, suggesting that perception and appraisal are relatively independent for CI users. Conclusions Perceptual abilities as measured by the CAMP had little to no relationship with music appraisals and little relationship with musical experience. The CAMP and IMBQ are feasible for routine clinical use, providing results consistent with previous thorough laboratory-based investigations. PMID:25177899

Italian Advisory Board: sFlt-1/PlGF ratio and preeclampsia, state of the art and developments in diagnostic, therapeutic and clinical management.

PubMed

Di Martino, Daniela; Cetin, Irene; Frusca, Tiziana; Ferrazzi, Enrico; Fuse', Federica; Gervasi, Maria Teresa; Plebani, Mario; Todros, Tullia

2016-11-01

Extensive research has been published, showing the usefulness of angiogenic markers in both diagnosis and subsequent prediction and management of preeclampsia and placenta-related disorders. Recent evidence provides a helpful cut off for the Elecsys ratio sFlt-1 to PlGF, that predicts preeclampsia development in women with sign and symptoms, before its clinical onset in the short term. In Europe, no accordance exists for the use of such kind of test in clinical practice; only German guidelines have recently taken it into account, as a diagnostic aid for preeclampsia, in conjunction with other clinical findings. This panel of Italian experts recently met, in order to review the literature and to promote the evaluation of the clinical utility of sFlt-1/PlGF ratio at the Italian country level, as regards: prediction of preeclampsia during the first trimester, prediction or exclusion of new onset or recurrence in patients with risk factors for preeclampsia, triage of patients suffering from gestational hypertension, evaluation of disease severity, prediction of adverse maternal and fetal outcomes. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

[Clinical significance of Q-angle under different conditions in recurrent patellar dislocation].

PubMed

Wang, Zhijie; Chen, You; Li, Anping; Long, Yi

2014-01-01

To investigate the clinical significance of Q-angle measuring under different conditions in female recurrent patellar dislocation female patients. Between August 2012 and March 2013, 10 female patients (11 knees) with recurrent patellar dislocation were collected as trial group; 20 female patients (20 knees) with simple meniscus injury were collected as control group at the same time. Q-angle was measured in extension, 30 degrees flexion, 30 degrees flexion with manual correction, and surgical correction in the trial group, and only in extension and 30 degrees flexion in the control group. Then the difference value of Q-angle between extension and 30 degrees flexion (Q-angle in extension subtracts Q-angle in 30 flexion) were calculated. Independent sample t-test was used to analyze Q-angle degrees in extension, 30 degrees flexion, and the changed degrees of 2 groups. The Q-angle between manual correction and surgical correction of the trial group was analyzed by paired t-test. The Q-angle in extension, Q-angle in 30 degrees flexion, and difference value of Q-angle between extension and 30 degrees flexion were (17.2 +/- 3.6), (14.3 +/- 3.0), and (2.9 +/- 1.9) degrees in the trial group and were (15.2 +/- 3.4), (14.4 +/- 3.5), and (0.8 +/- 1.7) degrees in the control group. No significant difference was found in Q-angle of extension or Q-angle of 30 degrees flexion between 2 groups (P > 0.05), but the difference value of Q-angle between extension and 30 degrees flexion in the trial group was significantly larger than that in the control group (t = 3.253, P = 0.003). The Q-angle in 30 degrees flexion with manual correction and surgical correction in the trial group was (19.8 +/- 3.4) degrees and (18.9 +/- 3.8) degrees respectively, showing no significant difference (t = 2.193, P = 0.053). When a female patient's Q-angle in 30 degrees flexion knee changes obviously compared with Q-angle in extension position, recurrent patellar dislocation should be considered. For female patients with recurrent patellar dislocation, the preoperative Q-angle in 30 degrees flexion with manual correction should be measured, which can help increasing the accuracy of evaluation whether rearrangement should be performed.

The LIBERTY study: Design of a prospective, observational, multicenter trial to evaluate the acute and long-term clinical and economic outcomes of real-world endovascular device interventions in treating peripheral artery disease.

PubMed

Adams, George L; Mustapha, Jihad; Gray, William; Hargus, Nick J; Martinsen, Brad J; Ansel, Gary; Jaff, Michael R

2016-04-01

Most peripheral artery disease (PAD) clinical device trials are supported by commercial manufacturers and designed for regulatory device approval, with extensive inclusion/exclusion criteria to support homogeneous patient populations. High-risk patients with advanced disease, including critical limb ischemia (CLI), are often excluded leading to difficulty in translating trial results into real-world clinical practice. As a result, physicians have no direct guidance regarding the use of endovascular devices. There is a need for objectively assessed studies to evaluate clinical, functional, and economic outcomes in PAD patient populations. LIBERTY is a prospective, observational, multicenter study sponsored by Cardiovascular Systems Inc (St Paul, MN) to evaluate procedural and long-term clinical and economic outcomes of endovascular device interventions in patients with symptomatic lower extremity PAD. Approximately 1,200 patients will be enrolled and followed up to 5 years: 500 patients in the "Claudicant Rutherford 2-3" arm, 600 in the "CLI Rutherford 4-5" arm, and 100 in the "CLI Rutherford 6" arm. The study will use 4 core laboratories for independent analysis and will evaluate the following: procedural and lesion success, rates of major adverse events, duplex ultrasound interpretations, wound status, quality of life, 6-minute walk test, and economic analysis. The LIBERTY Patient Risk Score(s) will be developed as a clinical predictor of outcomes to provide guidance for interventions in this patient population. LIBERTY will investigate real-world PAD patients treated with endovascular revascularization with rigorous study guidelines and independent oversight of outcomes. This study will provide observational, all-comer patient clinical data to guide future endovascular therapy. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

Application of Crossover Design for Conducting Rigorous Extension Evaluations

ERIC Educational Resources Information Center

Jayaratne, K. S. U.; Bird, Carolyn L.; McClelland, Jacquelyn W.

2013-01-01

With the increasing demand for accountability of Extension programming, Extension professionals need to apply rigorous evaluation designs. Randomized designs are useful to eliminate selection biases of program participants and to improve the accuracy of evaluation. However, randomized control designs are not practical to apply in Extension program…

Posterolaterally Displaced and Flexion Type Supracondylar Fractures are Associated with a Higher Risk of Open Reduction

PubMed Central

Novais, Eduardo N.; Carry, Patrick M.; Mark, Bryan J.; Sayan, DE; Miller, Nancy H.

2016-01-01

Objective To identify factors predictive of the risk of conversion from closed to open reduction. Methods ICD-9 codes were used to identify completely displaced pediatric supracondylar humerus fractures that underwent planned closed reduction and percutaneous pinning. Clinical and radiographic variables were retrospectively collected. Results Compared to posterior extension fractures, flexion [Risk Ratio (RR): 34.1, 95% CI: 8.1 to 143.6, p<0.0001] and posterolateral extension [RR: 6.0, 95% CI: 1.3 to 27.5, p=0.0221] fractures were significantly more likely to undergo conversion from closed to open reduction. Conclusions The direction of displacement should be considered during the pre-operative evaluation of supracondylar fractures. PMID:27035497

Characteristics of Human Brain Activity during the Evaluation of Service-to-Service Brand Extension

PubMed Central

Yang, Taeyang; Lee, Seungji; Seomoon, Eunbi; Kim, Sung-Phil

2018-01-01

Brand extension is a marketing strategy to apply the previously established brand name into new goods or service. A number of studies have reported the characteristics of human event-related potentials (ERPs) in response to the evaluation of goods-to-goods brand extension. In contrast, human brain responses to the evaluation of service extension are relatively unexplored. The aim of this study was investigating cognitive processes underlying the evaluation of service-to-service brand extension with electroencephalography (EEG). A total of 56 text stimuli composed of service brand name (S1) followed by extended service name (S2) were presented to participants. The EEG of participants was recorded while participants were asked to evaluate whether a given brand extension was acceptable or not. The behavioral results revealed that participants could evaluate brand extension though they had little knowledge about the extended services, indicating the role of brand in the evaluation of the services. Additionally, we developed a method of grouping brand extension stimuli according to the fit levels obtained from behavioral responses, instead of grouping of stimuli a priori. The ERP analysis identified three components during the evaluation of brand extension: N2, P300, and N400. No difference in the N2 amplitude was found among the different levels of a fit between S1 and S2. The P300 amplitude for the low level of fit was greater than those for higher levels (p < 0.05). The N400 amplitude was more negative for the mid- and high-level fits than the low level. The ERP results of P300 and N400 indicate that the early stage of brain extension evaluation might first detect low-fit brand extension as an improbable target followed by the late stage of the integration of S2 into S1. Along with previous findings, our results demonstrate different cognitive evaluation of service-to-service brand extension from goods-to-goods. PMID:29479313

Characteristics of Human Brain Activity during the Evaluation of Service-to-Service Brand Extension.

PubMed

Yang, Taeyang; Lee, Seungji; Seomoon, Eunbi; Kim, Sung-Phil

2018-01-01

Brand extension is a marketing strategy to apply the previously established brand name into new goods or service. A number of studies have reported the characteristics of human event-related potentials (ERPs) in response to the evaluation of goods-to-goods brand extension. In contrast, human brain responses to the evaluation of service extension are relatively unexplored. The aim of this study was investigating cognitive processes underlying the evaluation of service-to-service brand extension with electroencephalography (EEG). A total of 56 text stimuli composed of service brand name (S1) followed by extended service name (S2) were presented to participants. The EEG of participants was recorded while participants were asked to evaluate whether a given brand extension was acceptable or not. The behavioral results revealed that participants could evaluate brand extension though they had little knowledge about the extended services, indicating the role of brand in the evaluation of the services. Additionally, we developed a method of grouping brand extension stimuli according to the fit levels obtained from behavioral responses, instead of grouping of stimuli a priori . The ERP analysis identified three components during the evaluation of brand extension: N2, P300, and N400. No difference in the N2 amplitude was found among the different levels of a fit between S1 and S2. The P300 amplitude for the low level of fit was greater than those for higher levels ( p < 0.05). The N400 amplitude was more negative for the mid- and high-level fits than the low level. The ERP results of P300 and N400 indicate that the early stage of brain extension evaluation might first detect low-fit brand extension as an improbable target followed by the late stage of the integration of S2 into S1. Along with previous findings, our results demonstrate different cognitive evaluation of service-to-service brand extension from goods-to-goods.

Economic evaluations of clinical pharmacist interventions on hospital inpatients: a systematic review of recent literature.

PubMed

Gallagher, James; McCarthy, Suzanne; Byrne, Stephen

2014-12-01

Clinical and cost-effectiveness evidence are needed to justify the existence or extension of routine clinical pharmacy services in hospital settings. Previous reviews have indicated that clinical pharmacist interventions are likely to have a positive economic impact on hospital budgets but highlighted issues relating to the quality of studies. The primary aim of this review was to feature economic evaluations of clinical pharmacy services which targeted hospital inpatients. The review focused on the current cost-effectiveness status of different services, in addition to evaluating the quality of individual studies. Results of this systematic review were compared with cost-effectiveness and quality related findings of reviews which considered earlier time frames and alternative settings. A systematic review of the literature included a review of the following databases: Academic Search Complete, Cochrane Library, EconLit, Embase Elsevier, NHS Economic Evaluation Database and PubMed. Only studies with an economic assessment of a clinical pharmacy service provided in a hospital setting were included. Data relating to the cost-effectiveness was extracted from eligible studies. Methodologies employed and overall quality of the studies was also reviewed. A grading system was applied to determine the quality of studies. Consolidated Health Economic Evaluation Reporting Standards statement was employed to determine which aspects of a high quality health economic study were employed. Twenty studies were deemed eligible for inclusion. Overall, pharmacist interventions had a positive impact on hospital budgets. Only three studies (15 %) were deemed to be "good-quality" studies. No 'novel'clinical pharmacist intervention was identified during the course of this review. Clinical pharmacy interventions continue to provide cost savings. However, the standard of studies published has stagnated or even deteriorated in comparison with those included in previous reviews. Utilisation of published guidelines at initial stages of future studies may help improve the overall quality of studies.

Identification of design features to enhance utilization and acceptance of systems for Internet-based decision support at the point of care.

PubMed Central

Gadd, C. S.; Baskaran, P.; Lobach, D. F.

1998-01-01

Extensive utilization of point-of-care decision support systems will be largely dependent on the development of user interaction capabilities that make them effective clinical tools in patient care settings. This research identified critical design features of point-of-care decision support systems that are preferred by physicians, through a multi-method formative evaluation of an evolving prototype of an Internet-based clinical decision support system. Clinicians used four versions of the system--each highlighting a different functionality. Surveys and qualitative evaluation methodologies assessed clinicians' perceptions regarding system usability and usefulness. Our analyses identified features that improve perceived usability, such as telegraphic representations of guideline-related information, facile navigation, and a forgiving, flexible interface. Users also preferred features that enhance usefulness and motivate use, such as an encounter documentation tool and the availability of physician instruction and patient education materials. In addition to identifying design features that are relevant to efforts to develop clinical systems for point-of-care decision support, this study demonstrates the value of combining quantitative and qualitative methods of formative evaluation with an iterative system development strategy to implement new information technology in complex clinical settings. Images Figure 1 PMID:9929188

Magnetic resonance imaging of optic nerve

PubMed Central

Gala, Foram

2015-01-01

Optic nerves are the second pair of cranial nerves and are unique as they represent an extension of the central nervous system. Apart from clinical and ophthalmoscopic evaluation, imaging, especially magnetic resonance imaging (MRI), plays an important role in the complete evaluation of optic nerve and the entire visual pathway. In this pictorial essay, the authors describe segmental anatomy of the optic nerve and review the imaging findings of various conditions affecting the optic nerves. MRI allows excellent depiction of the intricate anatomy of optic nerves due to its excellent soft tissue contrast without exposure to ionizing radiation, better delineation of the entire visual pathway, and accurate evaluation of associated intracranial pathologies. PMID:26752822

Evaluating painful osteopenia in the elderly

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

Norris, M.A.; De Smet, A.A.

1991-06-01

Osteopenia is a frequent finding on radiographs of elderly patients. When the exam is performed for skeletal pain, this finding may be significant. The differential diagnosis for osteopenia is extensive, but individualizing the patient work-up begins with a careful clinical history and laboratory studies. Appropriate radiographic exams can then be requested. A plain radiograph is always the starting point, followed by--as indicated--a nuclear bone scan, computed tomography, and magnetic resonance imaging.

A focused ultrasound treatment system for moving targets (part I): generic system design and in-silico first-stage evaluation.

PubMed

Schwenke, Michael; Strehlow, Jan; Demedts, Daniel; Haase, Sabrina; Barrios Romero, Diego; Rothlübbers, Sven; von Dresky, Caroline; Zidowitz, Stephan; Georgii, Joachim; Mihcin, Senay; Bezzi, Mario; Tanner, Christine; Sat, Giora; Levy, Yoav; Jenne, Jürgen; Günther, Matthias; Melzer, Andreas; Preusser, Tobias

2017-01-01

Focused ultrasound (FUS) is entering clinical routine as a treatment option. Currently, no clinically available FUS treatment system features automated respiratory motion compensation. The required quality standards make developing such a system challenging. A novel FUS treatment system with motion compensation is described, developed with the goal of clinical use. The system comprises a clinically available MR device and FUS transducer system. The controller is very generic and could use any suitable MR or FUS device. MR image sequences (echo planar imaging) are acquired for both motion observation and thermometry. Based on anatomical feature tracking, motion predictions are estimated to compensate for processing delays. FUS control parameters are computed repeatedly and sent to the hardware to steer the focus to the (estimated) target position. All involved calculations produce individually known errors, yet their impact on therapy outcome is unclear. This is solved by defining an intuitive quality measure that compares the achieved temperature to the static scenario, resulting in an overall efficiency with respect to temperature rise. To allow for extensive testing of the system over wide ranges of parameters and algorithmic choices, we replace the actual MR and FUS devices by a virtual system. It emulates the hardware and, using numerical simulations of FUS during motion, predicts the local temperature rise in the tissue resulting from the controls it receives. With a clinically available monitoring image rate of 6.67 Hz and 20 FUS control updates per second, normal respiratory motion is estimated to be compensable with an estimated efficiency of 80%. This reduces to about 70% for motion scaled by 1.5. Extensive testing (6347 simulated sonications) over wide ranges of parameters shows that the main source of error is the temporal motion prediction. A history-based motion prediction method performs better than a simple linear extrapolator. The estimated efficiency of the new treatment system is already suited for clinical applications. The simulation-based in-silico testing as a first-stage validation reduces the efforts of real-world testing. Due to the extensible modular design, the described approach might lead to faster translations from research to clinical practice.

Outcomes of Orbital Floor Reconstruction After Extensive Maxillectomy Using the Computer-Assisted Fabricated Individual Titanium Mesh Technique.

PubMed

Zhang, Wen-Bo; Mao, Chi; Liu, Xiao-Jing; Guo, Chuan-Bin; Yu, Guang-Yan; Peng, Xin

2015-10-01

Orbital floor defects after extensive maxillectomy can cause severe esthetic and functional deformities. Orbital floor reconstruction using the computer-assisted fabricated individual titanium mesh technique is a promising method. This study evaluated the application and clinical outcomes of this technique. This retrospective study included 10 patients with orbital floor defects after maxillectomy performed from 2012 through 2014. A 3-dimensional individual stereo model based on mirror images of the unaffected orbit was obtained to fabricate an anatomically adapted titanium mesh using computer-assisted design and manufacturing. The titanium mesh was inserted into the defect using computer navigation. The postoperative globe projection and orbital volume were measured and the incidence of postoperative complications was evaluated. The average postoperative globe projection was 15.91 ± 1.80 mm on the affected side and 16.24 ± 2.24 mm on the unaffected side (P = .505), and the average postoperative orbital volume was 26.01 ± 1.28 and 25.57 ± 1.89 mL, respectively (P = .312). The mean mesh depth was 25.11 ± 2.13 mm. The mean follow-up period was 23.4 ± 7.7 months (12 to 34 months). Of the 10 patients, 9 did not develop diplopia or a decrease in visual acuity and ocular motility. Titanium mesh exposure was not observed in any patient. All patients were satisfied with their postoperative facial symmetry. Orbital floor reconstruction after extensive maxillectomy with an individual titanium mesh fabricated using computer-assisted techniques can preserve globe projection and orbital volume, resulting in successful clinical outcomes. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Extensive bleeding during surgical treatment for gingival overgrowth in a patient on haemodialysis--a case report and review of the literature.

PubMed

Nishide, N; Nishikawa, T; Kanamura, N

2005-12-01

Before performing renal transplantation, a most important concern is to control any infection, including oral infections before transplantation. The bleeding diathesis of patients with uraemia is a significant clinical concern, especially when surgery is required. A 44-year-old female patient on haemodialysis was referred for evaluation of gingival overgrowth. The patient was planning a renal transplantation two months later. As the lesions were not considered successfully treatable before transplantation, a gingivectomy and teeth extraction was performed. In pre-operative examinations, an abnormal bleeding time was not detected and other coagulation tests were normal. Under general anaesthesia, 19 teeth were extracted and overgrown gingiva was removed. During the operation, extensive blood loss of 1650ml occurred and four units of concentrated red blood cells were transfused. This study suggests that patients with renal failure undergoing dental surgery require careful pre-surgical evaluation including assessment of their coagulation ability.

Pharmacokinetic variability, efficacy and tolerability of eslicarbazepine acetate-A national approach to the evaluation of therapeutic drug monitoring data and clinical outcome.

PubMed

Svendsen, Torleiv; Brodtkorb, Eylert; Reimers, Arne; Molden, Espen; Sætre, Erik; Johannessen, Svein I; Johannessen Landmark, Cecilie

2017-01-01

Eslicarbazepine acetate (ESL) is a new antiepileptic drug (AED), still insufficiently studied regarding pharmacokinetic variability, efficacy and tolerability. The purpose of this study was to evaluate therapeutic drug monitoring (TDM) data in Norway and relate pharmacokinetic variability to clinical efficacy and tolerability in a long-term clinical setting in patients with refractory epilepsy. This retrospective observational study included TDM-data from the main laboratories and population data from the Norwegian Prescription Database in Norway, in addition to clinical data from medical records of adult patients using ESL for up to three years, whenever possible. TDM-data from 168 patients were utilized for assessment of pharmacokinetic variability, consisting of 71% of the total number of patients in Norway using ESL, 2011-14. Median daily dose of ESL was 800mg (range 400-1600mg), and median serum concentration of ESL was 53μmol/L (range 13-132μmol/L). Inter-patient variability of ESL was extensive, with 25-fold variability in concentration/dose ratios. Additional clinical data were available from 104 adult patients out of the 168, all with drug resistant focal epilepsy. After 1, 2 and 3 years follow-up, the retention rate of ESL was 83%, 72% and 64%, respectively. ESL was generally well tolerated as add-on treatment, but sedation, cognitive impairment and hyponatremia were reported. Hyponatremia (sodium <137mmol/L) was present in 36% of the patients, and lead to discontinuation in three. Pharmacokinetic variability of ESL was extensive and the demonstration of usefulness of TDM requires further studies. In patients with drug resistant focal Epilepsy, the high retention rate indicated good efficacy and tolerability. Hyponatremia was observed in one third of the patients. The present results point to a need for individualization of treatment and TDM may be useful. Copyright © 2016 Elsevier B.V. All rights reserved.

Lumbosacral multiradiculopathy responsive to antibiotic therapy: description of four patients with lumbar spondylosis and a superimposed Lyme disease.

PubMed

Luigetti, Marco; Vollaro, Stefano; Corbetto, Marzia; Salomone, Gaetano; Dicuonzo, Giordano; Scoppettuolo, Giancarlo; Di Lazzaro, Vincenzo

2014-12-01

Lyme disease is a diffuse zoonosis caused by spirochaetes of the Borrelia burgdorferi species complex. Neurological manifestations of the disease, involving central or peripheral nervous system, are common. This study describes four consecutive patients with an MRI-proven lumbosacral spondylosis, who complained of progressive worsening of symptoms in the last months in which serological evaluation suggested a superimposed B. Burgdorferi infection. Four patients, all from the Lazio region, were admitted to the Department of Neurology. Extensive laboratory studies and clinical, anamnestic and neurophysiological evaluation were performed in all cases. In all cases, anamnesis revealed a previous diagnosis of lumbosacral foraminal stenosis. Clinical and neurophysiological findings were consistent with a lumbosacral multiradiculopathy. Considering serological evaluation suggestive of a superimposed B. burgdorferi infection a proper antibiotic therapy was started. All cases showed a marked improvement of symptoms. Clinicians should be aware that in all cases of lumbosacral multiradiculopathy, even if a mechanical cause is documented, B. burgdorferi may be a simply treatable condition.

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology

PubMed Central

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-01-01

Objectives Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. Methods We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A ‘0–10’ agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Results Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. Conclusions This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. PMID:24827533

Kinematic evaluation of the finger's interphalangeal joints coupling mechanism--variability, flexion-extension differences, triggers, locking swanneck deformities, anthropometric correlations.

PubMed

Leijnse, J N A L; Quesada, P M; Spoor, C W

2010-08-26

The human finger contains tendon/ligament mechanisms essential for proper control. One mechanism couples the movements of the interphalangeal joints when the (unloaded) finger is flexed with active deep flexor. This study's aim was to accurately determine in a large finger sample the kinematics and variability of the coupled interphalangeal joint motions, for potential clinical and finger model validation applications. The data could also be applied to humanoid robotic hands. Sixty-eight fingers were measured in seventeen hands in nine subjects. Fingers exhibited great joint mobility variability, with passive proximal interphalangeal hyperextension ranging from zero to almost fifty degrees. Increased measurement accuracy was obtained by using marker frames to amplify finger segment motions. Gravitational forces on the marker frames were not found to invalidate measurements. The recorded interphalangeal joint trajectories were highly consistent, demonstrating the underlying coupling mechanism. The increased accuracy and large sample size allowed for evaluation of detailed trajectory variability, systematic differences between flexion and extension trajectories, and three trigger types, distinct from flexor tendon triggers, involving initial flexion deficits in either proximal or distal interphalangeal joint. The experimental methods, data and analysis should advance insight into normal and pathological finger biomechanics (e.g., swanneck deformities), and could help improve clinical differential diagnostics of trigger finger causes. The marker frame measuring method may be useful to quantify interphalangeal joints trajectories in surgical/rehabilitative outcome studies. The data as a whole provide the most comprehensive collection of interphalangeal joint trajectories for clinical reference and model validation known to us to date. 2010 Elsevier Ltd. All rights reserved.

Practical Application of Aspiration as an Outcome Indicator in Extension Evaluation

ERIC Educational Resources Information Center

Jayaratne, K. S. U.

2010-01-01

Extension educators need simple and accurate evaluation tools for program evaluation. This article explains how to use aspiration as an outcome indicator in Extension evaluation and introduces a practical evaluation tool. Aspiration can be described as the readiness for change. By recording participants' levels of aspiration, we will be able to…

Psychiatric adverse events during treatment with brodalumab: Analysis of psoriasis clinical trials.

PubMed

Lebwohl, Mark G; Papp, Kim A; Marangell, Lauren B; Koo, John; Blauvelt, Andrew; Gooderham, Melinda; Wu, Jashin J; Rastogi, Shipra; Harris, Susan; Pillai, Radhakrishnan; Israel, Robert J

2018-01-01

Individuals with psoriasis are at increased risk for psychiatric comorbidities, including suicidal ideation and behavior (SIB). To distinguish between the underlying risk and potential for treatment-induced psychiatric adverse events in patients with psoriasis being treated with brodalumab, a fully human anti-interleukin 17 receptor A monoclonal antibody. Data were evaluated from a placebo-controlled, phase 2 clinical trial; the open-label, long-term extension of the phase 2 clinical trial; and three phase 3, randomized, double-blind, controlled clinical trials (AMAGINE-1, AMAGINE-2, and AMAGINE-3) and their open-label, long-term extensions of patients with moderate-to-severe psoriasis. The analysis included 4464 patients with 9161.8 patient-years of brodalumab exposure. The follow-up time-adjusted incidence rates of SIB events were comparable between the brodalumab and ustekinumab groups throughout the 52-week controlled phases (0.20 vs 0.60 per 100 patient-years). In the brodalumab group, 4 completed suicides were reported, 1 of which was later adjudicated as indeterminate; all patients had underlying psychiatric disorders or stressors. There was no comparator arm past week 52. Controlled study periods were not powered to detect differences in rare events such as suicide. Comparison with controls and the timing of events do not indicate a causal relationship between SIB and brodalumab treatment. Copyright © 2017 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.

Transarticular fixation with cortical screws combined with dorsal laminectomy and partial discectomy as surgical treatment of degenerative lumbosacral stenosis in 17 dogs: clinical and computed tomography follow-up.

PubMed

Golini, Lorenzo; Kircher, Patrick R; Lewis, Fraser I; Steffen, Frank

2014-05-01

To describe clinical outcome and technical outcome assessed using computed tomography (CT) in dogs with degenerative lumbosacral stenosis (DLSS) treated by dorsal laminectomy, partial discectomy, and transarticular screw fixation. Retrospective observational case series. Dogs with DLSS (n = 17). Dogs with neurologic and magnetic resonance imaging (MRI) findings compatible with DLSS treated by dorsal laminectomy, partial discectomy and transarticular screw fixation were enrolled. Pre- and postoperative neurologic status was compared. Lumbosacral (LS) angle in extension and misalignment in preoperative MRI were compared with the postoperative CT. Residual mobility of the LS joint after fixation was also evaluated. Status of screws, presence of new bone formation over screw heads/articular facets and presence of adjacent segment disease (ASD) were assessed. Median CT follow-up was 12 months. Clinical improvement was seen in 13 dogs, 2 dogs had intermittent LS pain, and 2 dogs needed revision surgery. In 5 dogs, screws were either pulled out or broken. Reduction of LS angle in extension and misalignment was achieved. Residual mobility of the LS segment was present and ASD was not recognized. Transarticular screw fixation in dogs with DLSS is associated with a considerable number of technical failures and does not result in rigid stabilization; however, this did not significantly adversely influence clinical outcome. © Copyright 2014 by The American College of Veterinary Surgeons.

TRIAD: The Translational Research Informatics and Data Management Grid

PubMed Central

Payne, P.; Ervin, D.; Dhaval, R.; Borlawsky, T.; Lai, A.

2011-01-01

Objective Multi-disciplinary and multi-site biomedical research programs frequently require infrastructures capable of enabling the collection, management, analysis, and dissemination of heterogeneous, multi-dimensional, and distributed data and knowledge collections spanning organizational boundaries. We report on the design and initial deployment of an extensible biomedical informatics platform that is intended to address such requirements. Methods A common approach to distributed data, information, and knowledge management needs in the healthcare and life science settings is the deployment and use of a service-oriented architecture (SOA). Such SOA technologies provide for strongly-typed, semantically annotated, and stateful data and analytical services that can be combined into data and knowledge integration and analysis “pipelines.” Using this overall design pattern, we have implemented and evaluated an extensible SOA platform for clinical and translational science applications known as the Translational Research Informatics and Data-management grid (TRIAD). TRIAD is a derivative and extension of the caGrid middleware and has an emphasis on supporting agile “working interoperability” between data, information, and knowledge resources. Results Based upon initial verification and validation studies conducted in the context of a collection of driving clinical and translational research problems, we have been able to demonstrate that TRIAD achieves agile “working interoperability” between distributed data and knowledge sources. Conclusion Informed by our initial verification and validation studies, we believe TRIAD provides an example instance of a lightweight and readily adoptable approach to the use of SOA technologies in the clinical and translational research setting. Furthermore, our initial use cases illustrate the importance and efficacy of enabling “working interoperability” in heterogeneous biomedical environments. PMID:23616879

TRIAD: The Translational Research Informatics and Data Management Grid.

PubMed

Payne, P; Ervin, D; Dhaval, R; Borlawsky, T; Lai, A

2011-01-01

Multi-disciplinary and multi-site biomedical research programs frequently require infrastructures capable of enabling the collection, management, analysis, and dissemination of heterogeneous, multi-dimensional, and distributed data and knowledge collections spanning organizational boundaries. We report on the design and initial deployment of an extensible biomedical informatics platform that is intended to address such requirements. A common approach to distributed data, information, and knowledge management needs in the healthcare and life science settings is the deployment and use of a service-oriented architecture (SOA). Such SOA technologies provide for strongly-typed, semantically annotated, and stateful data and analytical services that can be combined into data and knowledge integration and analysis "pipelines." Using this overall design pattern, we have implemented and evaluated an extensible SOA platform for clinical and translational science applications known as the Translational Research Informatics and Data-management grid (TRIAD). TRIAD is a derivative and extension of the caGrid middleware and has an emphasis on supporting agile "working interoperability" between data, information, and knowledge resources. Based upon initial verification and validation studies conducted in the context of a collection of driving clinical and translational research problems, we have been able to demonstrate that TRIAD achieves agile "working interoperability" between distributed data and knowledge sources. Informed by our initial verification and validation studies, we believe TRIAD provides an example instance of a lightweight and readily adoptable approach to the use of SOA technologies in the clinical and translational research setting. Furthermore, our initial use cases illustrate the importance and efficacy of enabling "working interoperability" in heterogeneous biomedical environments.

Taxonomy for Assessing Evaluation Competencies in Extension

ERIC Educational Resources Information Center

Rodgers, Michelle S.; Hillaker, Barbara D.; Haas, Bruce E.; Peters, Cheryl

2012-01-01

Evaluation of public service programming is becoming increasingly important with current funding realities. The taxonomy of evaluation competencies compiled by Ghere et al. (2006) provided the starting place for Taxonomy for Assessing Evaluation Competencies in Extension. The Michigan State University Extension case study described here presents a…

Motor Rehabilitation Using Kinect: A Systematic Review.

PubMed

Da Gama, Alana; Fallavollita, Pascal; Teichrieb, Veronica; Navab, Nassir

2015-04-01

Interactive systems are being developed with the intention to help in the engagement of patients on various therapies. Amid the recent technological advances, Kinect™ from Microsoft (Redmond, WA) has helped pave the way on how user interaction technology facilitates and complements many clinical applications. In order to examine the actual status of Kinect developments for rehabilitation, this article presents a systematic review of articles that involve interactive, evaluative, and technical advances related to motor rehabilitation. Systematic research was performed in the IEEE Xplore and PubMed databases using the key word combination "Kinect AND rehabilitation" with the following inclusion criteria: (1) English language, (2) page number >4, (3) Kinect system for assistive interaction or clinical evaluation, or (4) Kinect system for improvement or evaluation of the sensor tracking or movement recognition. Quality assessment was performed by QualSyst standards. In total, 109 articles were found in the database research, from which 31 were included in the review: 13 were focused on the development of assistive systems for rehabilitation, 3 in evaluation, 3 in the applicability category, 7 on validation of Kinect anatomic and clinical evaluation, and 5 on improvement techniques. Quality analysis of all included articles is also presented with their respective QualSyst checklist scores. Research and development possibilities and future works with the Kinect for rehabilitation application are extensive. Methodological improvements when performing studies on this area need to be further investigated.

Evaluation in Extension.

ERIC Educational Resources Information Center

Byrn, Darcie; And Others

The authors have written this manual to aid workers in the Cooperative Extension Service of the United States to be better able to understand and apply the principles and methods of evaluation. The manual contains three sections which cover the nature and place of evaluation in extension work, the evaluation process, and the uses of evaluation…

Tools for Formative Evaluation: Gathering the Information Necessary for Program Improvement

ERIC Educational Resources Information Center

Jayaratne, K. S. U.

2016-01-01

New Extension educators experience a steep learning curve when attempting to develop effective Extension programs. Formative evaluation is helpful to new, and experienced, Extension educators in determining the changes necessary for making programs more effective. Formative evaluation is an essential part of program evaluation. However, its use…

Forced knee extension test is a manual test that correlates with the unstable feelings of patients with ACL injury before and after reconstruction.

PubMed

Shirasawa, Shinichi; Koga, Hideyuki; Horie, Masafumi; Nakamura, Tomomasa; Watanabe, Toshifumi; Sekiya, Ichiro; Muneta, Takeshi

2016-12-01

To investigate fear in patients with anterior cruciate ligament (ACL) injury before and after reconstruction, a forced knee extension (FKE) test was performed. The correlation of the test results was evaluated with the subjective function, sports performance and objective parameters. The study included 102 patients with unilateral ACL reconstruction using a semitendinosus tendon with full clinical evaluation. This study was retrospective and determined the longitudinal results of the FKE test and investigated the effects on the subjective and objective outcomes at 2years. Preoperatively, 47% of patients showed positive FKE tests. The number of positive FKE tests was 31% at six months and 15% at 24months after ACL reconstruction. At two years, there were statistically significant differences between the FKE test positives and negatives regarding both subjective knee recovery (P=0.0095) and sports performance (P=0.0006). A new manual test, called the forced knee extension test, for fear in patients with ACL injury before and after reconstruction was introduced. The apprehension remained positive in 15% of the patients two years after ACL reconstruction, which affected subjective recovery of knee function and sports performance. Copyright © 2016 Elsevier B.V. All rights reserved.

Monte-Carlo model development for evaluation of current clinical target volume definition for heterogeneous and hypoxic glioblastoma.

PubMed

Moghaddasi, L; Bezak, E; Harriss-Phillips, W

2016-05-07

Clinical target volume (CTV) determination may be complex and subjective. In this work a microscopic-scale tumour model was developed to evaluate current CTV practices in glioblastoma multiforme (GBM) external radiotherapy. Previously, a Geant4 cell-based dosimetry model was developed to calculate the dose deposited in individual GBM cells. Microscopic extension probability (MEP) models were then developed using Matlab-2012a. The results of the cell-based dosimetry model and MEP models were combined to calculate survival fractions (SF) for CTV margins of 2.0 and 2.5 cm. In the current work, oxygenation and heterogeneous radiosensitivity profiles were incorporated into the GBM model. The genetic heterogeneity was modelled using a range of α/β values (linear-quadratic model parameters) associated with different GBM cell lines. These values were distributed among the cells randomly, taken from a Gaussian-weighted sample of α/β values. Cellular oxygen pressure was distributed randomly taken from a sample weighted to profiles obtained from literature. Three types of GBM models were analysed: homogeneous-normoxic, heterogeneous-normoxic, and heterogeneous-hypoxic. The SF in different regions of the tumour model and the effect of the CTV margin extension from 2.0-2.5 cm on SFs were investigated for three MEP models. The SF within the beam was increased by up to three and two orders of magnitude following incorporation of heterogeneous radiosensitivities and hypoxia, respectively, in the GBM model. However, the total SF was shown to be overdominated by the presence of tumour cells in the penumbra region and to a lesser extent by genetic heterogeneity and hypoxia. CTV extension by 0.5 cm reduced the SF by a maximum of 78.6  ±  3.3%, 78.5  ±  3.3%, and 77.7  ±  3.1% for homogeneous and heterogeneous-normoxic, and heterogeneous hypoxic GBMs, respectively. Monte-Carlo model was developed to quantitatively evaluate SF for genetically heterogeneous and hypoxic GBM with two CTV margins and three MEP distributions. The results suggest that photon therapy may not provide cure for hypoxic and genetically heterogeneous GBM. However, the extension of the CTV margin by 0.5 cm could be beneficial to delay the recurrence time for this tumour type due to significant increase in tumour cell irradiation.

Microsurgical and Endoscopic Anatomy for Intradural Temporal Bone Drilling and Applications of the Electromagnetic Navigation System: Various Extensions of the Retrosigmoid Approach.

PubMed

Matsushima, Ken; Komune, Noritaka; Matsuo, Satoshi; Kohno, Michihiro

2017-07-01

The use of the retrosigmoid approach has recently been expanded by several modifications, including the suprameatal, transmeatal, suprajugular, and inframeatal extensions. Intradural temporal bone drilling without damaging vital structures inside or beside the bone, such as the internal carotid artery and jugular bulb, is a key step for these extensions. This study aimed to examine the microsurgical and endoscopic anatomy of the extensions of the retrosigmoid approach and to evaluate the clinical feasibility of an electromagnetic navigation system during intradural temporal bone drilling. Five temporal bones and 8 cadaveric cerebellopontine angles were examined to clarify the anatomy of retrosigmoid intradural temporal bone drilling. Twenty additional cerebellopontine angles were dissected in a clinical setting with an electromagnetic navigation system while measuring the target registration errors at 8 surgical landmarks on and inside the temporal bone. Retrosigmoid intradural temporal bone drilling expanded the surgical exposure to allow access to the petroclival and parasellar regions (suprameatal), internal acoustic meatus (transmeatal), upper jugular foramen (suprajugular), and petrous apex (inframeatal). The electromagnetic navigation continuously guided the drilling without line of sight limitation, and its small devices were easily manipulated in the deep and narrow surgical field in the posterior fossa. Mean target registration error was less than 0.50 mm during these procedures. The combination of endoscopic and microsurgical techniques aids in achieving optimal exposure for retrosigmoid intradural temporal bone drilling. The electromagnetic navigation system had clear advantages with acceptable accuracy including the usability of small devices without line of sight limitation. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluation of clinical and financial outcomes of a new no-sting barrier film and barrier cream in a large UK primary care organisation.

PubMed

Stephen-Haynes, Jackie; Stephens, Claire

2013-12-01

The study involves 95 subjects within a UK Primary Care Organisation and was undertaken in two arms. The objective was to determine the clinical outcomes and clinical acceptability of a newly available range of no-sting barrier film and no-sting barrier cream products offering significant financial benefits. The importance of undertaking this study is underpinned by evidence in the literature relating to the use of no-sting barrier preparations within clinical practice. The first part of the study (arm 1) involved extensive evaluation of either the film or cream barrier in 36 patients and was compared to existing standardised barrier protection care within the organisation. The results indicated that the new product range met all the criteria for formulary inclusion and following this the barrier range was further evaluated in arm 2, 33 patients with barrier cream and 26 patients with barrier film. The entire study was conducted over a 3-month period with patient treatment lasting a minimum of 2 days to a maximum 4-week period adhering to the agreed evaluation protocol as approved by clinical governance. In arm 1 (n = 36), the clinical expectation of the product was met in 32 cases relating to ease of use, conformability, no-sting, quick drying, ease of absorption, compatibility with devices, frequency of application, prevention and management including visual skin improvement resulting in a recommendation for formulary listing in 31 of 36 cases. In arm 2 (n = 59), barrier film and barrier cream performance was consistently rated same as, better than or much better than the existing barrier used. A formulary listing recommendation was made in 51 of 59 cases. © 2012 The Authors. International Wound Journal © 2012 John Wiley & Sons Ltd and Medicalhelplines.com Inc.

Isolated scaphoid dislocation associated with axial carpal dissociation: an unusual injury report.

PubMed

Horton, Todd; Shin, Alexander Y; Cooney, William P

2004-11-01

We present a report of a patient with an isolated scaphoid dislocation associated with a hyperextension and axial loading injury of the carpus required a careful and extensive clinical and radiographic evaluation leading to surgical intervention to reduce and stabilize the scaphoid and to reduce and hold internally the axial carpal injury. Knowledge of the anatomy and the potential injury patterns of the carpus will aid the hand surgeon with injury recognition and proper treatment.

Differential effects of power training versus functional task practice on compensation and restoration of arm function after stroke.

PubMed

Corti, Manuela; McGuirk, Theresa E; Wu, Samuel S; Patten, Carolynn

2012-09-01

Improved upper-extremity (UE) movement with stroke rehabilitation may involve restoration of more normal or development of compensatory movement patterns. The authors investigated the differential effects of functional task practice (FTP) and dynamic resistance training (POWER) on clinical function and reaching kinematics in an effort to distinguish between mechanisms of gains. A total of 14 hemiparetic individuals were randomly assigned to 10 weeks of either FTP or POWER and then crossed over to 10 weeks of the alternate treatment. Treatment order A was FTP followed by POWER, whereas treatment order B was POWER followed by FTP. Evaluation before and after each treatment block included a battery of clinical evaluations and kinematics of paretic UE functional reach to grasp. Both FTP and POWER improved movement accuracy, as revealed by a shift toward normal, including fewer submovements and reduced reach-path ratio. However, active range of motion revealed differential treatment effects. Shoulder flexion and elbow extension decreased with FTP and were associated with increased trunk displacement. In contrast, shoulder flexion and elbow extension excursion increased with POWER and were associated with significantly reduced trunk displacement. Treatment order B (POWER followed by FTP) revealed greater overall improvements. FTP increases compensatory movement patterns to improve UE function. POWER leads to more normal movement patterns. POWER prior to FTP may enhance the benefits of repetitive task practice.

A Model for Evaluating eXtension Communities of Practice

ERIC Educational Resources Information Center

Kelsey, Kathleen D.; Stafne, Eric T.

2012-01-01

As Americans shift their work and leisure activities online, Extension seeks to remain viable by delivering programs through a website known as eXtension. eXtension is predicated on the voluntary labor of Extension specialists and educators who form Communities of Practice to create and deliver content through the website. Evaluation of eXtension…

Decreased flexion contracture after total knee arthroplasty using Botulinum toxin A: a randomized controlled trial.

PubMed

Smith, Eric B; Shafi, Karim A; Greis, Ari C; Maltenfort, Mitchell G; Chen, Antonia F

2016-10-01

Flexion contracture after total knee arthroplasty (TKA) can cause significant dissatisfaction. Botulinum toxin A has shown improved extension in patients with spastic flexion contractures after TKA. The purpose of this study was to evaluate whether Botulinum toxin A improves knee extension for any patient with flexion contractures following TKA. A prospective, double-blinded, randomized controlled trial was conducted. Fourteen patients (15 knees), with a flexion contracture (≥10°) one month postoperatively, were randomized to receive either Botulinum toxin A or saline placebo to the affected hamstrings. The subject, surgeon, and administering physiatrist were blinded to the treatment group throughout the study. Subject range of motion (ROM) was evaluated at 1, 6, and 12 months following injection. Differences were tested using mixed-effects regression to control for multiple measurements. The initial post-operative flexion contracture averaged 19° ± 6° in the Botulinum toxin A group and 13° ± 3° in the saline group. Injections were performed 53 and 57 days after TKA in the Botulinum toxin A and saline groups, respectively. Post-injection extension improved to an average of 8, 5, and 1 degrees for BTX and 4, 2, and 1 degrees for SAL, at 1, 6, and 12 months, respectively, compared to pre-injection extension (p < 0.0001). Improvement in knee extension at 1 year improved 18° ± 7.5° for Botulinum toxin A and 12° ± 2° for saline (p = 0.04). No complications resulted from either injection. Patients who received Botulinum toxin A or placebo were able to achieve near full extension one year after surgery. There was a statistically significant improvement in the amount of extension achieved at 1 year with Botulinum toxin A, but this may be of little clinical significance. Since achieving full extension is important for patient function and satisfaction, novel techniques to address this issue deserve special attention. I.

Surgical Strategies in Childhood Craniopharyngioma

PubMed Central

Flitsch, Jörg; Müller, Hermann Lothar; Burkhardt, Till

2011-01-01

Craniopharyngiomas are biologically benign lesions (WHO Grade 1) of the sellar and suprasellar region, associated with a serious morbidity. About 50% of these tumors become clinically apparent during childhood. Clinical symptoms include headaches, chiasm syndrome, hydrocephalus, pituitary insufficiencies, and obesity. Growth arrest is a typical symptom in children. The treatment of craniopharyngiomas includes surgery as well as radiotherapy. The goal of surgery varies according to the tumor location and extension and may range from complete resection to biopsy. Surgical complications are well known and cause constant evaluation of surgical strategies. Diencephalic obesity is related to surgical manipulation of hypothalamic tissue. Therefore, a classification system for craniopharyngiomas based on preoperative MRI is suggested by the authors. Recurrences are frequent in craniopharyngiomas, even after complete or gross-total resection. Radiotherapy is therefore recommended to patients with incomplete resections. However, the ideal time for radiotherapy after surgery is under discussion. The treatment of craniopharyngiomas requires an interdisciplinary and multimodal approach. Each patient should receive an individually tailored treatment. Surgically, different approaches as well as different degrees of resection can be considered, depending on tumor location and tumor extension. PMID:22645514

Clinical Decision Support Alert Appropriateness: A Review and Proposal for Improvement

PubMed Central

McCoy, Allison B.; Thomas, Eric J.; Krousel-Wood, Marie; Sittig, Dean F.

2014-01-01

Background Many healthcare providers are adopting clinical decision support (CDS) systems to improve patient safety and meet meaningful use requirements. Computerized alerts that prompt clinicians about drug-allergy, drug-drug, and drug-disease warnings or provide dosing guidance are most commonly implemented. Alert overrides, which occur when clinicians do not follow the guidance presented by the alert, can hinder improved patient outcomes. Methods We present a review of CDS alerts and describe a proposal to develop novel methods for evaluating and improving CDS alerts that builds upon traditional informatics approaches. Our proposal incorporates previously described models for predicting alert overrides that utilize retrospective chart review to determine which alerts are clinically relevant and which overrides are justifiable. Results Despite increasing implementations of CDS alerts, detailed evaluations rarely occur because of the extensive labor involved in manual chart reviews to determine alert and response appropriateness. Further, most studies have solely evaluated alert overrides that are appropriate or justifiable. Our proposal expands the use of web-based monitoring tools with an interactive dashboard for evaluating CDS alert and response appropriateness that incorporates the predictive models. The dashboard provides 2 views, an alert detail view and a patient detail view, to provide a full history of alerts and help put the patient's events in context. Conclusion The proposed research introduces several innovations to address the challenges and gaps in alert evaluations. This research can transform alert evaluation processes across healthcare settings, leading to improved CDS, reduced alert fatigue, and increased patient safety. PMID:24940129

Poly(amido amine) dendrimers in oral delivery.

PubMed

Yellepeddi, Venkata K; Ghandehari, Hamidreza

2016-01-01

Poly(amidoamine) (PAMAM) dendrimers have been extensively investigated for oral delivery applications due to their ability to translocate across the gastrointestinal epithelium. In this Review, we highlight recent advances in the evaluation of PAMAM dendrimers as oral drug delivery carriers. Specifically, toxicity, mechanisms of transepithelial transport, models of the intestinal epithelial barrier including isolated human intestinal tissue model, detection of dendrimers, and surface modification are discussed. We also highlight evaluation of various PAMAM dendrimer-drug conjugates for their ability to transport across gastrointestinal epithelium for improved oral bioavailability. In addition, current challenges and future trends for clinical translation of PAMAM dendrimers as carriers for oral delivery are discussed.

Poly(amido amine) dendrimers in oral delivery

PubMed Central

Yellepeddi, Venkata K.; Ghandehari, Hamidreza

2016-01-01

ABSTRACT Poly(amidoamine) (PAMAM) dendrimers have been extensively investigated for oral delivery applications due to their ability to translocate across the gastrointestinal epithelium. In this Review, we highlight recent advances in the evaluation of PAMAM dendrimers as oral drug delivery carriers. Specifically, toxicity, mechanisms of transepithelial transport, models of the intestinal epithelial barrier including isolated human intestinal tissue model, detection of dendrimers, and surface modification are discussed. We also highlight evaluation of various PAMAM dendrimer-drug conjugates for their ability to transport across gastrointestinal epithelium for improved oral bioavailability. In addition, current challenges and future trends for clinical translation of PAMAM dendrimers as carriers for oral delivery are discussed. PMID:27358755

Diagnostic imaging of trabecular bone microstructure for oral implants: a literature review.

PubMed

Ibrahim, N; Parsa, A; Hassan, B; van der Stelt, P; Wismeijer, D

2013-01-01

Several dental implant studies have reported that radiographic evaluation of bone quality can aid in reducing implant failure. Bone quality is assessed in terms of its quantity, density, trabecular characteristics and cells. Current imaging modalities vary widely in their efficiency in assessing trabecular structures, especially in a clinical setting. Most are very costly, require an extensive scanning procedure coupled with a high radiation dose and are only partially suitable for patient use. This review examines the current literature regarding diagnostic imaging assessment of trabecular microstructure prior to oral implant placement and suggests cone beam CT as a method of choice for evaluating trabecular bone microstructure.

Aggressive squamous cell carcinoma in Kindler syndrome.

PubMed

Emanuel, Patrick O; Rudikoff, Donald; Phelps, Robert G

2006-01-01

A 57-year-old Hispanic man with a personal and family history of bullae and photosensitivity presented with a fungating, ulcerated squamous cell carcinoma on his left hand (Figure 1). Physical examination showed conjunctival injection, ectropion, symblepharon, urethral stricture, loss of teeth, short stature, and nail dystrophy. There was reticulated erythema, atrophy, hyperpigmentation and hypopigmentation, and telangiectasia of sun-exposed skin of the face, neck, and hands consistent with poikiloderma (Figure 2). In addition, there was foreshortening of the left thumb and sclerodermoid changes of his hands (Figure 3). Radiation therapy was applied to shrink the tumor before a local excision was performed. However, a local recurrence followed and axillary lymph nodes became clinically palpable, necessitating amputation and lymph node dissection. Extensive histologic evaluation of the specimen obtained following left arm amputation and lymph node dissection showed moderate-to-poorly differentiated deeply invasive squamous cell carcinoma. Two of 3 axillary lymph nodes were positive for metastatic carcinoma. A random biopsy of the trunk showed epidermal atrophy, telangiectasia, a perivascular lymphocytic infiltration, and pigment-laden macrophages consistent with poikiloderma. Electron microscopy illustrated extensive reduplication of the basement membrane, with loops, curls, and free extensions of the basal lamina in the superficial dermis; reduced numbers of hemidesmosomes and anchoring fibrils; and a basement membrane focally devoid of basal cells (Figure 4). On the basis of the clinical features and the characteristic basement zone changes, a diagnosis of Kindler syndrome was made.

One-Step Treatment for Patellar Cartilage Defects With a Cell-Free Osteochondral Scaffold: A Prospective Clinical and MRI Evaluation.

PubMed

Perdisa, Francesco; Filardo, Giuseppe; Sessa, Andrea; Busacca, Maurizio; Zaffagnini, Stefano; Marcacci, Maurilio; Kon, Elizaveta

2017-06-01

The treatment of symptomatic cartilage defects of the patella is particularly challenging, and no gold standard is currently available. To evaluate the clinical results of a biphasic cell-free collagen-hydroxyapatite scaffold and to evaluate osteochondral tissue regeneration with magnetic resonance imaging (MRI). Case series; Level of evidence, 4. Thirty-four patients (18 men and 16 women; mean ± SD: age, 30.0 ± 10 years) were treated by scaffold implantation for knee chondral or osteochondral lesions of the patella (area, 2.1 ± 1 cm 2 ). The clinical evaluation was performed prospectively at 12 and 24 months via the IKDC (International Knee Documentation Committee; objective and subjective) and Tegner scores. MRI evaluation was performed at both follow-ups in 18 lesions through the MOCART score (magnetic resonance observation of cartilage repair tissue) and specific subchondral bone parameters. A statistically significant improvement in all the scores was observed at 12- and 24-month follow-up as compared with the basal evaluation. The IKDC subjective score improved from 39.5 ± 14.5 to 61.9 ± 14.5 at 12 months ( P > .0005) with a further increase to 67.6 ± 17.4 at 24 months of follow-up (12-24 months, P = .020). The MRI evaluation showed a stable value of the MOCART score between 12 and 24 months, with a complete filling of the cartilage in 87.0% of the lesions, complete integration of the graft in 95.7%, and intact repair tissue surface in 69.6% at final follow-up. The presence of osteophytes or more extensive bony overgrowth was documented in 47.8% of the patients of this series, but no correlation was found between MRI findings and clinical outcome. The implantation of a cell-free collagen-hydroxyapatite osteochondral scaffold provided a clinical improvement at short-term follow-up for the treatment of patellar cartilage defects. Women had lower outcomes, and the need for realignment procedures led to a slower recovery. MRI evaluation showed some abnormal findings with the presence of bone overgrowth, but no correlation has been found with the clinical outcome.

Clinical diagnostic dilemma of intracranial germinoma manifesting as wide skull base extension.

PubMed

Zhou, Zhi-hang; Zhang, Hai-bo; Rao, Jun; Bian, Xiu-wu

2014-09-01

The aims of this study were to present an uncommon intracranial germinoma manifesting as skull base extension and analyze its clinical characteristics to give valuable insight into such uncommon radiologic variant. This is a clinical study of a 15-year-old girl with intracranial germinoma manifesting as skull base extension. Clinical characteristics, magnetic resonance imaging scan observations, pathologic findings, and flow of the treatment procedure were presented and analyzed. She had a 5-month history of diuresis and diplopia. magnetic resonance imaging observation displayed a neoplasm located in the right-side central skull base and suprasellar area with wide extension into the cavernous sinus, intraorbital region, ethmoidal sinus, sphenoid sinus, and pituitary fossa. After administration of contrast medium, strong and heterogeneous enhancement of the mass was observed, with a dural tail sign along the right cerebellar tentorial. Right pterional approach was performed, and intraoperative histologic examination suspected the diagnosis of germinoma; partial resection was achieved, and postoperative radiotherapy was administered. Cranial nerve palsy improved greatly 6 months postoperatively. Although highly unusual, germinoma should be included in the differential diagnosis of all masses with extension along the midline region of skull base, especially when it happens in young female patients.

CLINICAL APPROACH TO THE DIAGNOSTIC EVALUATION OF HERDITARY AND ACQUIRED NEUROMUSCULAR DISEASES

PubMed Central

McDonald, Craig M.

2012-01-01

SYNOPSIS In the context of a neuromuscular disease diagnostic evaluation, the clinician still must be able to obtain a relevant patient and family history and perform focused general, musculoskeletal, neurologic and functional physical examinations to direct further diagnostic evaluations. Laboratory studies for hereditary neuromuscular diseases include relevant molecular genetic studies. The EMG and nerve conduction studies remain an extension of the physical examination and help to guide further diagnostic studies such as molecular genetic studies, and muscle and nerve biopsies. All diagnostic information needs to be interpreted not in isolation, but within the context of relevant historical information, family history, physical examination findings, and laboratory data, electrophysiologic findings, pathologic findings, and molecular genetic findings if obtained. PMID:22938875

Effects of Resection of Posterior Condyles of Femur on Extension Gap of Knee Joint in Total Knee Arthroplasty.

PubMed

Seo, Seung-Suk; Kim, Chang-Wan; Seo, Jin-Hyuk; Kim, Do-Hun; Kim, Ok-Gul; Lee, Chang-Rack

2017-06-01

When evaluating the effects of the preparation of the flexion gap on the extension gap in total knee arthroplasty (TKA), the effects of posterior condylar resection and osteophyte removal on the extension gap should be differentiated. Although the amount of osteophytes differs between patients, posterior condylar resection is a procedure that is routinely implemented in TKA. The aim of this study was to assess the effects of the resection of the posterior condyle of the femur on the extension gap in posterior-stabilized (PS) TKA. We enrolled 40 knees that underwent PS TKA between July 2010 and February 2011 with no or minimal osteophytes in the posterior compartment and a varus deformity of <15°. We measured the extension gap before and after the resection of the posterior condyle of the femur using a tensor under 20 and 40 lb of distraction force. Under 20 lb of distraction force, the average extension gap was 13.3 mm (standard deviation [SD], 1.6) before and 13.8 mm (SD, 1.6) after posterior condylar resection. Under 40 lb of distraction force, the average extension gap was 15.1 mm (SD, 1.5) before and 16.1 mm (SD, 1.7) after posterior condylar resection. The resection of the posterior condyle of the femur in PS TKA increased the extension gap. However, this increase was only by approximately 1 mm. In conclusion, posterior condylar resection does increase the extension gap by approximately 1 mm. However, in most case, this change in unlikely to be clinically important. Copyright © 2017 Elsevier Inc. All rights reserved.

Various causes and clinical characteristics in vertigo in children with normal eardrums.

PubMed

Choung, Yun-Hoon; Park, Keehyun; Moon, Sung-Kyun; Kim, Chul-Ho; Ryu, Sang Jun

2003-08-01

The differential diagnosis of vertigo in children is extensive. Otitis media and middle ear effusion could be the most common causes of vertigo in children, but there are some problems in detecting the other causes for vertigo because they are one of most frequent diseases of childhood. The purpose of this study is to review the clinical characteristics and both the audiological and vestibular findings of vertigo in children with normal eardrums, who do not show otitis media or middle ear effusion, and to assist in making a differential diagnosis of vertigo. The fifty five children (< 16 years old) with vertigo, who visited the Department of Otolaryngology, Ajou University Hospital, Suwon, South Korea between January 1995 and December 2001 were selected for this study. These excluded the patients with abnormal eardrums/tympanograms or those that did not perform questionnaires, audiological, or vestibular evaluations. They were retrospectively analyzed for clinical symptoms, vestibular functions, and differential diagnosis. The most common causes for vertigo in children were migraine in 17 (30.9%) and benign paroxysmal vertigo of childhood (BPVC) in 14 (25.5%). Other less frequent causes included four cases of trauma, two cases each of Meniere's disease, delayed endolymphatic hydrops, benign positional vertigo, and one case only for cerebellopontine angle tumor, seizure, acute vestibular neuritis, juvenile rheumatoid arthritis, leaving ten cases (18.2%) as unclassified. Abnormal findings were noted in 13 (23.6%) in pure tone audiogram, 3 (5.5%) in positioning test, 6 (10.9%) in bithermal caloric test, and 36 (65.5%) in rotation chair test. The vertigo in children with normal eardrums, who did not show otitis media or middle ear effusion, was most commonly caused by migraine and BPVC. These findings have shown to be very different from those with adult vertigo. The evaluation of vertigo in children requires a questionnaire for extensive and complete history taking, audiograms and vestibular function tests. And in selected cases, electroencephalography, hematological evaluation, imaging of the brain or temporal bone should be performed.

Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study.

PubMed

Jacobsen, Paula L; Harper, Linda; Chrones, Lambros; Chan, Serena; Mahableshwarkar, Atul R

2015-09-01

Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in patients who completed one of three randomized, double-blind, placebo-controlled, 8-week vortioxetine trials. All patients were switched to 10 mg/day vortioxetine for week 1, then adjusted between 15 and 20 mg for the remainder of the study, but not downtitrated below 15 mg. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), vital signs, laboratory values, physical examination, and the Columbia-Suicide Severity Rating Scale. Efficacy measures included the Montgomery-Åsberg Depression Rating Scale, the Hamilton Anxiety Scale, the Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability Scale. Of the 1075 patients enrolled, 1073 received at least one dose of vortioxetine and 538 (50.0%) completed the study. A total of 537 patients withdrew early, with 115 (10.7% of the original study population) withdrawing because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the most common TEAEs (≥10%) were nausea and headache. Laboratory values, vital signs, and physical examinations revealed no trends of clinical concern. The mean Montgomery-Åsberg Depression Rating Scale total score was 19.9 at the start of the extension study and 9.0 after 52 weeks of treatment (observed cases). Similar improvements were observed with the Hamilton Anxiety Scale (Δ-4.2), the Clinical Global Impression Scale-Severity of Illness (Δ-1.2), and the Sheehan Disability Scale (Δ-4.7) total scores after 52 weeks of treatment (observed case). In this 52-week, flexible-dose OLE study, 15 and 20 mg vortioxetine were safe and well tolerated. After entry into this study, patients continued to show improvement in depression and anxiety symptoms, as well as overall functioning, throughout the treatment period.

EELAB: an innovative educational resource in occupational medicine.

PubMed

Zhou, A Y; Dodman, J; Hussey, L; Sen, D; Rayner, C; Zarin, N; Agius, R

2017-07-01

Postgraduate education, training and clinical governance in occupational medicine (OM) require easily accessible yet rigorous, research and evidence-based tools based on actual clinical practice. To develop and evaluate an online resource helping physicians develop their OM skills using their own cases of work-related ill-health (WRIH). WRIH data reported by general practitioners (GPs) to The Health and Occupation Research (THOR) network were used to identify common OM clinical problems, their reported causes and management. Searches were undertaken for corresponding evidence-based and audit guidelines. A web portal entitled Electronic, Experiential, Learning, Audit and Benchmarking (EELAB) was designed to enable access to interactive resources preferably by entering data about actual cases. EELAB offered disease-specific online learning and self-assessment, self-audit of clinical management against external standards and benchmarking against their peers' practices as recorded in the research database. The resource was made available to 250 GPs and 224 occupational physicians in UK as well as postgraduate OM students for evaluation. Feedback was generally very favourable with physicians reporting their EELAB use for case-based assignments. Comments such as those suggesting a wider range of clinical conditions have guided further improvement. External peer-reviewed evaluation resulted in accreditation by the Royal College of GPs and by the Faculties of OM (FOM) of London and of Ireland. This innovative resource has been shown to achieve education, self-audit and benchmarking objectives, based on the participants' clinical practice and an extensive research database. © The Author 2017. Published by Oxford University Press on behalf of the Society of Occupational Medicine. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Implementation of workflow engine technology to deliver basic clinical decision support functionality.

PubMed

Huser, Vojtech; Rasmussen, Luke V; Oberg, Ryan; Starren, Justin B

2011-04-10

Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform.

Non-formal educator use of evaluation results.

PubMed

Baughman, Sarah; Boyd, Heather H; Franz, Nancy K

2012-08-01

Increasing demands for accountability in educational programming have resulted in increasing calls for program evaluation in educational organizations. Many organizations include conducting program evaluations as part of the job responsibilities of program staff. Cooperative Extension is a complex organization offering non-formal educational programs through land grant universities. Many Extension services require non-formal educational program evaluations be conducted by field-based Extension educators. Evaluation research has focused primarily on the efforts of professional, external evaluators. The work of program staff with many responsibilities including program evaluation has received little attention. This study examined how field based Extension educators (i.e. program staff) in four Extension services use the results of evaluations of programs that they have conducted themselves. Four types of evaluation use are measured and explored; instrumental use, conceptual use, persuasive use and process use. Results indicate that there are few programmatic changes as a result of evaluation findings among the non-formal educators surveyed in this study. Extension educators tend to use evaluation results to persuade others about the value of their programs and learn from the evaluation process. Evaluation use is driven by accountability measures with very little program improvement use as measured in this study. Practical implications include delineating accountability and program improvement tasks within complex organizations in order to align evaluation efforts and to improve the results of both. There is some evidence that evaluation capacity building efforts may be increasing instrumental use by educators evaluating their own programs. Copyright © 2011 Elsevier Ltd. All rights reserved.

Determination of acrosin activity of boar spermatozoa by the clinical method: optimization of the assay and changes during short-term storage of semen.

PubMed

Glogowski, J; Demianowicz, W; Piros, B; Ciereszko, A

1998-10-15

A clinical assay to evaluate total acrosin activity developed for human semen has been optimized for use in boar spermatozoa. The main modifications included a decrease of sperm number per assay from 1.0 to 10.0 x 10(6) to 12.5 to 75.0 x 10(3) spermatozoa, and the time of incubation from 180 to 60 min. Linearity of response for differing quantities of spermatozoa was maintained. Extensive washing of spermatozoa was necessary to eliminate seminal plasma, the source of acrosin inhibitors. Seminal plasma that was diluted 1000 times inhibited acrosin activity by about 50%. To abolish the inhibitory effect of seminal plasma it was necessary to use 25,000-fold dilution. Total acrosin activity of boar spermatozoa was about 100 times higher than that of human spermatozoa. Acrosin activity of boar spermatozoa in extended semen decreased during 7 d of storage. These results indicate that the clinical assay of acrosin activity can be used for boar spermatozoa to evaluate the quality of boar semen.

Invasive growth patterns of juvenile nasopharyngeal angiofibroma: radiological imaging and clinical implications.

PubMed

Szymańska, Anna; Szymański, Marcin; Czekajska-Chehab, Elżbieta; Szczerbo-Trojanowska, Małgorzata

2014-07-01

Juvenile nasopharyngeal angiofibroma is a benign lesion with locally aggressive nature. Knowledge of its typical growth patterns is crucial for precise preoperative staging and adequate preoperative patient counseling. This pictorial essay focuses on characteristic radiological features and paths of invasive growth of this rare tumor. Also, the impact of accurate preoperative evaluation of tumor extensions on surgical planning and results of treatment are discussed. © The Foundation Acta Radiologica 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Navigation-based tibial rotation at 90° of flexion is associated with better range of motion in navigated total knee arthroplasty.

PubMed

Ishida, Kazunari; Shibanuma, Nao; Matsumoto, Tomoyuki; Sasaki, Hiroshi; Takayama, Koji; Hiroshima, Yuji; Kuroda, Ryosuke; Kurosaka, Masahiro

2016-08-01

In clinical practice, people with better femorotibial rotation in the flexed position often achieve a favourable postoperative maximum flexion angle (MFA). However, no objective data have been reported to support this clinical observation. In the present study, we aimed to investigate the correlation between the amount of intraoperative rotation and the pre- and postoperative flexion angles. Fifty-five patients with varus osteoarthritis undergoing computer-assisted posterior-stabilized total knee arthroplasty (TKA) were enrolled. After registration, rotational stress was applied towards the knee joint, and the rotational angles were recorded by using a navigation system at maximum extension and 90° of flexion. After implantation, rotational stress was applied for a second time, and the angles were recorded once more. The MFA was measured before surgery and 1 month after surgery, and the correlation between the amount of femorotibial rotation during surgery and the MFA was statistically evaluated. Although the amount of tibial rotation at maximum extension was not correlated with the MFA, the amount of tibial rotation at 90° of flexion after registration was positively correlated with the pre- and postoperative MFA (both p < 0.005). However, no significant relationship was observed between the amount of tibial rotation after implantation and the postoperative MFA (n.s.). The results showed that better femorotibial rotation at 90° of flexion is associated with a favourable postoperative MFA, suggesting that the flexibility of the surrounding soft tissues is an important factor for obtaining a better MFA, which has important clinical relevance. Hence, further evaluation of navigation-based kinematics during TKA may provide useful information on MFA. Diagnostic studies, development of diagnostic criteria in a consecutive series of patients, and a universally applied "gold" standard, Level II.

Soleus neurotomy for treatment of the spastic equinus foot. Groupe d'Evaluation et de Traitement de la Spasticité et de la Dystonie.

PubMed

Decq, P; Filipetti, P; Cubillos, A; Slavov, V; Lefaucheur, J P; Nguyen, J P

2000-11-01

This prospective, nonrandomized, noncontrolled study was performed to evaluate the results of a new type of neurotomy, namely the soleus neurotomy, for treatment of the spastic equinus foot. Between May 1996 and March 1998, 46 patients were treated for a spastic equinus foot. Clinical status, spasticity (Ashworth Scale score), and kinematic parameters of the gait were determined before and after surgery. The neurotomy was performed on the upper nerve of the soleus in all cases and was associated with other neurotomies (lower nerve of the soleus, 21 patients; gastrocnemius, 9 patients, tibialis posterior, 18 patients; flexor hallucis longus, 16 patients; and flexor digitorum longus, 17 patients). The mean follow-up period was 15 months (range, 8-28 mo). The equinus deformity disappeared clinically in all patients. Before the operation, all patients had an Ashworth Scale score of 2, with an inexhaustible clonus present on knee extension and persisting with knee flexion (Tardieu Scale score, 4), which was abolished in 95% of the patients after surgery. Two patients still had some clonus on knee extension; this did not interfere with their clinical improvement. Knee recurvatum disappeared in eight patients. Analysis of kinematic parameters demonstrated a statistically significant increase in joint motion of the second rocker (P = 0.0026) of the ankle during stance. The duration of the stance or swing phase, length of the walking cycle, and velocity or rate of spontaneous walking were not significantly modified. The study demonstrated that soleus neurotomy is effective for the treatment of spastic equinus foot, leading to abolition of spasticity and improvement in the range of ankle motion during the stance phase of gait.

Clinical outcome following DIAM implantation for symptomatic lumbar internal disk disruption: a 3-year retrospective analysis

PubMed Central

Lu, Kang; Liliang, Po-Chou; Wang, Hao-Kuang; Chen, Jui-Sheng; Chen, Te-Yuan; Huang, Ruyi; Chen, Han-Jung

2016-01-01

Background/objective Internal disk disruption (IDD), an early event of lumbar disk degeneration, is the most common cause of low back pain. Since increased intradiskal pressure (IDP) is associated with symptoms and progression of disk degeneration, unloading a painful disk with an interspinous process device (IPD) is a rational treatment option. The goal of this study was to evaluate the effectiveness of dynamic stabilization with an IPD in the treatment of symptomatic IDD of the lumbar spine. Patients and methods Patients with symptomatic IDD were treated with implantation of an IPD, the device for intervertebral assisted motion (DIAM). Diagnosis of IDD was based on typical MRI finding of posterior annular high-intensity zone and positive provocative test on discography. IDP was analyzed intraoperatively. Axial back and leg pain was evaluated with visual analog scale, functional status with Oswestry Disability Index, and final clinical outcomes with Odom criteria. Data from 34 patients followed up for at least 3 years were collected. Results DIAM implantation significantly reduced IDP (n=11, P<0.0001). All 34 patients reported symptom relief. Thirty-one patients (91%) remained symptom free until the last followups. Three patients (9%) experienced recurrence of pain, of which the causes were unrelated to the IDD or surgery. Disk status at the DIAM-implanted segments remained stable. Segmental flexion/extension mobility was preserved in 27 of 30 patients with preoperative mobility. No proximal or distal adjacent segment degeneration was observed. The final clinical outcomes were excellent/good in 31 and fair/poor in three patients. Conclusion For patients with symptomatic IDD, dynamic stabilization with DIAM provides pain relief and functional improvement. The implantation maintains disk status and prevents progression of disk degeneration, without compromising segmental flexion/extension mobility or causing adjacent segment degeneration. PMID:27826214

Development of EULAR recommendations for the reporting of clinical trial extension studies in rheumatology.

PubMed

Buch, Maya H; Silva-Fernandez, Lucia; Carmona, Loreto; Aletaha, Daniel; Christensen, Robin; Combe, Bernard; Emery, Paul; Ferraccioli, Gianfranco; Guillemin, Francis; Kvien, Tore K; Landewe, Robert; Pavelka, Karel; Saag, Kenneth; Smolen, Josef S; Symmons, Deborah; van der Heijde, Désirée; Welling, Joep; Wells, George; Westhovens, Rene; Zink, Angela; Boers, Maarten

2015-06-01

Our initiative aimed to produce recommendations on post-randomised controlled trial (RCT) trial extension studies (TES) reporting using European League Against Rheumatism (EULAR) standard operating procedures in order to achieve more meaningful output and standardisation of reports. We formed a task force of 22 participants comprising RCT experts, clinical epidemiologists and patient representatives. A two-stage Delphi survey was conducted to discuss the domains of evaluation of a TES and definitions. A '0-10' agreement scale assessed each domain and definition. The resulting set of recommendations was further refined and a final vote taken for task force acceptance. Seven key domains and individual components were evaluated and led to agreed recommendations including definition of a TES (100% agreement), minimal data necessary (100% agreement), method of data analysis (agreement mean (SD) scores ranging between 7.9 (0.84) and 9.0 (2.16)) and reporting of results as well as ethical issues. Key recommendations included reporting of absolute numbers at each stage from the RCT to TES with reasons given for drop-out at each stage, and inclusion of a flowchart detailing change in numbers at each stage and focus (mean (SD) agreement 9.9 (0.36)). A final vote accepted the set of recommendations. This EULAR task force provides recommendations for implementation in future TES to ensure a standardised approach to reporting. Use of this document should provide the rheumatology community with a more accurate and meaningful output from future TES, enabling better understanding and more confident application in clinical practice towards improving patient outcomes. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Comparison of the clinical and cognitive features of genetically positive ALS patients from the largest tertiary center in Serbia.

PubMed

Marjanović, Ivan V; Selak-Djokić, Biljana; Perić, Stojan; Janković, Milena; Arsenijević, Vladimir; Basta, Ivana; Lavrnić, Dragana; Stefanova, Elka; Stević, Zorica

2017-06-01

Discovering novel mutations in C9orf72, FUS, ANG, and TDP-43 genes in ALS patients arises necessities for better clinical characterizations of these subjects. The aim is to determine clinical and cognitive profile of genetically positive Serbian ALS patients. 241 ALS patients were included in the study (17 familiar and 224 apparently sporadic). The following genes were analyzed: SOD1, C9orf72, ANG, FUS, and TDP-43. An extensive battery of classic neuropsychological tests was used in 27 ALS patients (22 SOD1 positive and 5 SOD1 negative) and 82 healthy controls (HCs). Overall 37 (15.4%) of 241 ALS patients carried mutations in tested genes-among 17 familiar ALS patients 16 (94.1%) were positive and among 224 apparently sporadic 21 (9.4%) had causative mutation. Mutations in SOD1 gene were the most common, representing 27 (73.0%) of all genetically positive ALS patients. The main clinical characteristics of SOD1 positive patients were: spinal onset in lower extremities, common sphincter and sensitive disturbances, and dysexecutive syndrome. Within SOD1 positive patients, we noticed somewhat earlier onset in patients with A145G, sensory and sphincter disturbances were dominant in patients with L144F, while D90A patients had significant sensory involvement. SOD1 negative group consisted of ten (27.0%) patients (six C9orf72, two ANG, one TDP-43, and one patient baring triple FUS, C9orf72 expansion, and ANG variants). Bulbar involvement and more extensive neuropsychological impairment (including executive, visuospatial, and memory difficulties) were the main features of SOD1 negative cohort. Our results suggest that meaningful clinical suspicion of certain ALS genotype might be made based on thorough clinical evaluation of patients.

Financial Management of a Large Multi-site Randomized Clinical Trial

PubMed Central

Sheffet, Alice J.; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E.; Longbottom, Mary E.; Howard, Virginia J.; Marler, John R.; Brott, Thomas G.

2014-01-01

Background The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years’ funding ($21,112,866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2,500 randomized participants at 40 sites. Aims Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Methods Projections of the original grant’s fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant’s fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Results Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2,500 targeted sample size, 138 (5.5%) were randomized during the first five years and 1,387 (55.5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13,845) of the projected per-patient costs ($152,992) of the fixed model. Conclusions Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. PMID:24661748

Financial management of a large multisite randomized clinical trial.

PubMed

Sheffet, Alice J; Flaxman, Linda; Tom, MeeLee; Hughes, Susan E; Longbottom, Mary E; Howard, Virginia J; Marler, John R; Brott, Thomas G

2014-08-01

The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) received five years' funding ($21 112 866) from the National Institutes of Health to compare carotid stenting to surgery for stroke prevention in 2500 randomized participants at 40 sites. Herein we evaluate the change in the CREST budget from a fixed to variable-cost model and recommend strategies for the financial management of large-scale clinical trials. Projections of the original grant's fixed-cost model were compared to the actual costs of the revised variable-cost model. The original grant's fixed-cost budget included salaries, fringe benefits, and other direct and indirect costs. For the variable-cost model, the costs were actual payments to the clinical sites and core centers based upon actual trial enrollment. We compared annual direct and indirect costs and per-patient cost for both the fixed and variable models. Differences between clinical site and core center expenditures were also calculated. Using a variable-cost budget for clinical sites, funding was extended by no-cost extension from five to eight years. Randomizing sites tripled from 34 to 109. Of the 2500 targeted sample size, 138 (5·5%) were randomized during the first five years and 1387 (55·5%) during the no-cost extension. The actual per-patient costs of the variable model were 9% ($13 845) of the projected per-patient costs ($152 992) of the fixed model. Performance-based budgets conserve funding, promote compliance, and allow for additional sites at modest additional cost. Costs of large-scale clinical trials can thus be reduced through effective management without compromising scientific integrity. © 2014 The Authors. International Journal of Stroke © 2014 World Stroke Organization.

Safety and tolerability of adjunctive rosiglitazone treatment for children with uncomplicated malaria.

PubMed

Varo, Rosauro; Crowley, Valerie M; Sitoe, Antonio; Madrid, Lola; Serghides, Lena; Bila, Rubao; Mucavele, Helio; Mayor, Alfredo; Bassat, Quique; Kain, Kevin C

2017-05-23

Despite the widespread use and availability of rapidly acting anti-malarials, the fatality rate of severe malaria in sub-Saharan Africa remains high. Adjunctive therapies that target the host response to malaria infection may further decrease mortality over that of anti-malarial agents alone. Peroxisome proliferator-activated receptor-gamma agonists (e.g. rosiglitazone) have been shown to act on several pathways implicated in the pathogenesis of severe malaria and may improve clinical outcome as an adjunctive intervention. In this study, the safety and tolerability of adjunctive rosiglitazone in paediatric uncomplicated malaria infection was evaluated in Mozambique, as a prelude to its evaluation in a randomized controlled trial in paediatric severe malaria. The study was a prospective, randomized, double-blind, placebo-controlled, phase IIa trial of rosiglitazone (0.045 mg/kg/dose) twice daily for 4 days versus placebo as adjunctive treatment in addition to Mozambican standard of care (artemisinin combination therapy Coartem ® ) in children with uncomplicated malaria. The primary outcomes were tolerability and safety, including clinical, haematological, biochemical, and electrocardiographic evaluations. Thirty children were enrolled: 20 were assigned to rosiglitazone and 10 to placebo. Rosiglitazone treatment did not induce hypoglycaemia nor significantly alter clinical, biochemical, haematological, or electrocardiographic parameters. Adjunctive rosiglitazone was safe and well-tolerated in children with uncomplicated malaria, permitting the extension of its evaluation as adjunctive therapy for severe malaria. The trial is registered with Clinicaltrials.gov, NCT02694874.

Nomograms to predict the pathological stage of clinically localized prostate cancer in Korean men: comparison with western predictive tools using decision curve analysis.

PubMed

Jeong, Chang Wook; Jeong, Seong Jin; Hong, Sung Kyu; Lee, Seung Bae; Ku, Ja Hyeon; Byun, Seok-Soo; Jeong, Hyeon; Kwak, Cheol; Kim, Hyeon Hoe; Lee, Eunsik; Lee, Sang Eun

2012-09-01

To develop and evaluate nomograms to predict the pathological stage of clinically localized prostate cancer after radical prostatectomy in Korean men. We reviewed the medical records of 2041 patients who had clinical stages T1c-T3a prostate cancer and were treated solely with radical prostatectomy at two hospitals. Logistic regressions were carried out to predict organ-confined disease, extraprostatic extension, seminal vesicle invasion, and lymph node metastasis using preoperative variables and resulting nomograms. Internal validations were assessed using the area under the receiver operating characteristic curve and calibration plot, and then external validations were carried out on 129 patients from another hospital. Head-to-head comparisons with 2007 Partin tables and Cancer of the Prostate Risk Assessment score were carried out using the area under the curve and decision curve analysis. The significant predictors for organ-confined disease and extraprostatic extension were clinical stage, prostate-specific antigen, Gleason score and a percent positive core of biopsy. Significant predictors for seminal vesicle invasion were prostate-specific antigen, Gleason score and percent positive core, and those for lymph node metastasis were prostate-specific antigen and percent positive core. The area under the curve of established nomograms for organ-confined disease, extraprostatic extension, seminal vesicle invasion and lymph node metastasis were 0.809, 0.804, 0.889 and 0.838, respectively. The nomograms were well calibrated and externally validated. These nomograms showed significantly higher accuracies and net benefits than two Western tools in Korean men. This is the first study to have developed and fully validated nomograms to predict the pathological stage of prostate cancer in an Asian population. These nomograms might be more accurate and useful for Korean men than other predictive models developed using Western populations. © 2012 The Japanese Urological Association.

Quantitative magnetic resonance imaging analysis of the cross-sectional areas of the anconeus epitrochlearis muscle, cubital tunnel, and ulnar nerve with the elbow in extension in patients with and without ulnar neuropathy.

PubMed

Eng, Hing Y; Gunio, Drew A; Benitez, Carlos L

2018-05-10

The purpose of this study was to assess the cross-sectional area of the anconeus epitrochlearis muscle (AEM), cubital tunnel, and ulnar nerve with the elbow in extension in patients with and without ulnar neuropathy. We performed a retrospective, level IV review of elbow magnetic resonance imaging (MRI) studies. Elbow MRI studies of 32 patients with an AEM (26 men and 6 women, aged 18-60 years), 32 randomly selected patients without an AEM (aged 16-71 years), and 32 patients with clinical ulnar neuritis (22 men and 10 women, aged 24-76 years) were reviewed. We evaluated the ulnar nerve cross-sectional area proximal to, within, and distal to the cubital tunnel; AEM cross-sectional area; and cubital tunnel cross-sectional area. We found no significant difference in the nerve caliber between patients with and without an AEM. No correlation was found between the AEM cross-sectional area and ulnar nerve cross-sectional area within the cubital tunnel (r = 0.14). The mean cubital tunnel cross-sectional area was larger in patients with an AEM. Only 4 of the 32 patients with an AEM had findings of ulnar neuritis on MRI. Of the 32 patients with a clinical diagnosis of ulnar neuritis, only 2 had an AEM. With the elbow in extension, the presence or cross-sectional area of an AEM does not correlate with the area of the ulnar nerve or cubital tunnel. Only a small number of individuals with MRI evidence of an AEM had clinical evidence of ulnar neuropathy. Likewise, MRI evidence of an AEM was found in only a small number of individuals with clinical evidence of ulnar neuropathy. Copyright © 2018 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Is a More Comprehensive Surgery Necessary in Patients With Uterine Serous Carcinoma?

PubMed

Touhami, Omar; Trinh, Xuan-Bich; Gregoire, Jean; Sebastianelli, Alexandra; Renaud, Marie-Claude; Grondin, Katherine; Plante, Marie

2015-09-01

Uterine serous carcinoma (USC) is an aggressive histologic subtype of endometrial cancer that shares similarities to serous ovarian cancer, with a propensity for spread to the upper abdomen, a high recurrence rate, and a poor prognosis. The aim of this study was to determine whether the traditional surgical staging procedure for endometrial cancer was adequate for USC or whether a more extensive surgery, similar to the staging procedure for ovarian cancer, needs to be performed. Specifically, the roles of omentectomy and sentinel lymph node (SLN) mapping were evaluated. We retrospectively identified cases of presumed clinical stage I USC at our institution from April 2005 to March 2014. Medical records were reviewed for the following information: age at diagnosis, preoperative imaging, operative findings, surgical procedure, and final histology with definitive International Federation of Gynecology and Obstetrics stage. A total of 39 patients with presumed clinical stage I USC were identified. According to the final pathology report, the surgical stage was as follows: 17 stage IA (44%), 8 stage IB (20%), 3 stage II (8%), 2 stage IIIA (5%), 6 stage IIIC1 (15%), 1 IIIC2 (3%), and 2 stage IVB (5%). Therefore, 14 patients (36%) were surgically upstaged, but none of the patients had their clinical disease upstaged by virtue of finding microscopic metastatic disease in an otherwise normal-looking omentum. Sentinel lymph node mapping was performed in 19 patients (42%). Sensitivity and negative predictive value of SLN mapping were 100% when at least 1 SLN was identified. The detection of microscopic disease in radiologically and clinically normal-appearing omentum seems to be rare in USC. Sentinel lymph node mapping seems to be valuable in the serous subtype of endometrial cancer. A less extensive surgery may be possible in patients with USC as it seems to provide the same information as a more extensive surgery.

Creating an anthropomorphic digital MR phantom—an extensible tool for comparing and evaluating quantitative imaging algorithms

NASA Astrophysics Data System (ADS)

Bosca, Ryan J.; Jackson, Edward F.

2016-01-01

Assessing and mitigating the various sources of bias and variance associated with image quantification algorithms is essential to the use of such algorithms in clinical research and practice. Assessment is usually accomplished with grid-based digital reference objects (DRO) or, more recently, digital anthropomorphic phantoms based on normal human anatomy. Publicly available digital anthropomorphic phantoms can provide a basis for generating realistic model-based DROs that incorporate the heterogeneity commonly found in pathology. Using a publicly available vascular input function (VIF) and digital anthropomorphic phantom of a normal human brain, a methodology was developed to generate a DRO based on the general kinetic model (GKM) that represented realistic and heterogeneously enhancing pathology. GKM parameters were estimated from a deidentified clinical dynamic contrast-enhanced (DCE) MRI exam. This clinical imaging volume was co-registered with a discrete tissue model, and model parameters estimated from clinical images were used to synthesize a DCE-MRI exam that consisted of normal brain tissues and a heterogeneously enhancing brain tumor. An example application of spatial smoothing was used to illustrate potential applications in assessing quantitative imaging algorithms. A voxel-wise Bland-Altman analysis demonstrated negligible differences between the parameters estimated with and without spatial smoothing (using a small radius Gaussian kernel). In this work, we reported an extensible methodology for generating model-based anthropomorphic DROs containing normal and pathological tissue that can be used to assess quantitative imaging algorithms.

[Characteristics of Dupuytren's disease in women. A study of 67 cases].

PubMed

Ferry, N; Lasserre, G; Pauchot, J; Lepage, D; Tropet, Y

2013-12-01

The aim of this study was to identify the clinical differences of the Dupuytren's disease in gender. Testosterone induces an increase of the Dupuytren's fibroblast proliferation via androgen's receptors. Testosterone rate increases during pregnancy and menopausis. We also reached a link between this factors and the clinical aspects of Dupuytren' disease in the women of our study. This retrospective, comparative study was about all women and a randomized number of men, who underwent surgery for Dupuytren' disease between 1980 and 2010. We analysed all the epidemiologic and clinical data, the surgery procedures and the complications. Pre- and postoperative measurements of the extension lack of all the joints were performed with a manual goniometer. Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire was used to evaluate the patients function. This specific data of women were reached. Sixty-seven women and 69 men were compared. The complex regional pain syndrome was significantly more common in women and the correction of the proximal interphalangeal joint was significantly lower in women. Recurrence rate and mean follow up were not statistically different. Mean DASH score was higher in women. We have not found any association between menopausis, pregnancy and the average age at presentation of the disease, the recurrence rate or the extension rate. The prognosis of the Dupuytren's disease is worse in women than in men. Other studies are necessary to reach the link between the testosterone and the clinical history of the disease in women. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

Combined Endoscopic/Sonographic-Based Risk Matrix Model for Predicting One-Year Risk of Surgery: A Prospective Observational Study of a Tertiary Center Severe/Refractory Crohn's Disease Cohort.

PubMed

Rispo, Antonio; Imperatore, Nicola; Testa, Anna; Bucci, Luigi; Luglio, Gaetano; De Palma, Giovanni Domenico; Rea, Matilde; Nardone, Olga Maria; Caporaso, Nicola; Castiglione, Fabiana

2018-03-08

In the management of Crohn's Disease (CD) patients, having a simple score combining clinical, endoscopic and imaging features to predict the risk of surgery could help to tailor treatment more effectively. AIMS: to prospectively evaluate the one-year risk factors for surgery in refractory/severe CD and to generate a risk matrix for predicting the probability of surgery at one year. CD patients needing a disease re-assessment at our tertiary IBD centre underwent clinical, laboratory, endoscopy and bowel sonography (BS) examinations within one week. The optimal cut-off values in predicting surgery were identified using ROC curves for Simple Endoscopic Score for CD (SES-CD), bowel wall thickness (BWT) at BS, and small bowel CD extension at BS. Binary logistic regression and Cox's regression were then carried out. Finally, the probabilities of surgery were calculated for selected baseline levels of covariates and results were arranged in a prediction matrix. Of 100 CD patients, 30 underwent surgery within one year. SES-CD©9 (OR 15.3; p<0.001), BWT©7 mm (OR 15.8; p<0.001), small bowel CD extension at BS©33 cm (OR 8.23; p<0.001) and stricturing/penetrating behavior (OR 4.3; p<0.001) were the only independent factors predictive of surgery at one-year based on binary logistic and Cox's regressions. Our matrix model combined these risk factors and the probability of surgery ranged from 0.48% to 87.5% (sixteen combinations). Our risk matrix combining clinical, endoscopic and ultrasonographic findings can accurately predict the one-year risk of surgery in patients with severe/refractory CD requiring a disease re-evaluation. This tool could be of value in clinical practice, serving as the basis for a tailored management of CD patients.

[Morphological signs of inflammatory activity in different clinical forms of drug-resistant pulmonary tuberculosis].

PubMed

Elipashev, A A; Nikolsky, V O; Shprykov, A S

to determine whether the activity of tuberculous inflammation is associated with different clinical forms of drug-resistant pulmonary tuberculosis. The material taken from 310 patients operated on in 2010-2015 were retrospectively examined. The patients underwent economical lung resections of limited extent (typical and atypical ones of up to 3 segments) for circumscribed forms of tuberculosis with bacterial excretion. A study group consisted of 161 (51.9%) patients with drug-resistant variants of pulmonary tuberculosis. A control group included 149 (48.1%) patients with preserved susceptibility of Mycobacterium tuberculosis to anti-TB drugs. The activity of specific changes in tuberculosis was morphologically evaluated in accordance with the classification proposed by B.M. Ariel in 1998. The highest activity of fourth-to-fifth degree specific inflammation, including that outside the primary involvement focus, was obtained in the drug-resistant pulmonary tuberculosis group due to the predominance of patients with cavernous and fibrous-cavernous tuberculosis versus those in whom the susceptibility to chemotherapeutic agents was preserved. A macroscopic study showed that the primary lesion focus had a median size in one-half of the all the examinees; but large tuberculomas, caverns, and fibrous caverns over 4 cm in diameter were multiple and detected in the drug-resistant pulmonary tuberculosis group. Multidrug resistance was observed in more than 60% of the patients with fibrous-cavernous pulmonary tuberculosis, extensive drug resistance was seen in those with cavernous tuberculosis, which is an aggravating factor. The data obtained from the morphological study of the intraoperative material can specify the clinical form of tuberculosis and evaluate the efficiency of preoperative specific therapy. The highest activity of specific inflammation was observed in patients with multiple drug-resistant pulmonary tuberculosis, the prevalence of third-to-fourth degree specific changes was seen in those with multiple and extensively drug-resistant tuberculosis. The findings suggest that the activity of tuberculous inflammation is associated with different clinical forms of drug-resistant tuberculosis and with a spectrum of drug resistance.

Does Previous Hip Surgery Effect the Outcome of Tönnis Triple Periacetabular Osteotomy? Mid-Term Results.

PubMed

Konya, Mehmet Nuri; Aydn, Bahattin Kerem; Yldrm, Timur; Sofu, Hakan; Gürsu, Sarper

2016-03-01

Hip dysplasia (HD) is 1 of the major reasons of coxarthrosis. The goal of the treatment of HD by Tönnis triple pelvic osteotomy (TPAO) is to improve the function of hip joint while relieving pain, delaying and possibly preventing end-stage arthritis. The aim of this study is to compare the clinical and radiological results of TPAO to determine if previous surgery has a negative effect on TPAO.Patients operated with TPAO between 2005 and 2010, included in this study. Patients divided into 2 groups: primary acetabular dysplasia (PAD) and residual acetabular dysplasia (RAD). Prepostoperatively, hip range of motion, Harris hip score (HHS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) hip score, visual analog scores (VAS), impingement tests, and also the presence of Trendelenburg sign (TS) were investigated for clinical evaluation. For radiological analysis pre-postoperative, anterior-posterior (AP) pelvis and faux profile radiographs were used. Acetabular index, lateral center edge (LCE) angle, and Sharp angles were measured by AP pelvis; anterior center edge (ACE) angle were measured by faux profile radiography. All the clinical and radiological data of the groups were analyzed separately for the pre-postoperative scores also the amount of improvement in all parameters were analyzed.SPSS20 (SPSS Inc., Chicago, IL) was used for statistical analysis. Wilcoxon test, McNemar test, paired t tests, and Mann-Whitney U tests were used to compare the groups. P < 0.05 were defined as statistically significant.Study included 27 patients: 17 patients were in PAD and 10 patients were in RAD. The mean follow-up period was 6.2 years (5.2-10.3 years). In all patients, the radiological and the clinical outcomes were better after TPAO except the flexion of the hip parameter. When the patient groups were evaluated as pre-postoperatively, more statistically significant parameters were found in the PAD group when compared with RAD group. Extension, impingement, TS, VAS, HHS, WOMAC score parameters in clinical outcome and LCE, ACE, Sharp angle, coverage ratio in radiological results were significantly better in PAD group postoperatively but in RAD group; only extension, VAS, HHS, and WOMAC parameters were clinically and LCE and Coverage ratio were significantly different compared with the preoperative measurements. The change of the parameters that used for the evaluation of clinical and radiological results did not show a significant difference between groups.Our data suggest that TPAO can be performed on patients with HD for both groups. Although there were fewer parameters which changed significantly after TPAO in RAD patients; the improvement of radiological and clinical results was similar for groups. Further long-term follow-up studies with large number of patients are needed to determine the proper results of TPAO.

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

PubMed

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

2014-12-20

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

Searching for a relevant definition of sarcopenia: results from the cross-sectional EPIDOS study

PubMed Central

Dupuy, Charlotte; Lauwers-Cances, Valérie; Guyonnet, Sophie; Gentil, Catherine; Abellan Van Kan, Gabor; Beauchet, Olivier; Schott, Anne-Marie; Vellas, Bruno; Rolland, Yves

2015-01-01

Background The diversity of definitions proposed for sarcopenia has been rarely tested in the same population, and so far, their clinical utilities for predicting physical difficulties could not be clearly understood. Our objective is to report the prevalence of sarcopenia and the characteristics of sarcopenic community-dwelling older women according to the different definitions of sarcopenia currently proposed. We also assessed these definitions for their incremental predictive value over currently standard predictors for some self-reported difficulties in physical function and knee extension strength. Methods Cross-sectional analysis included data from 3025 non-disabled women aged 75 years or older without previous history of hip fracture from the inclusion visit of the EPIDémiologie de l'OStéoporose study. A total body composition evaluation was available for 2725 women. Sarcopenia was defined using six different definitions of sarcopenia based on different muscle mass, gait speed, and grip strength cut-offs. Self-reported difficulties in physical function and knee extension strength were collected. Logistic regression and multiple linear regression models were built for each physical dysfunction, and the predictive capacity of sarcopenia (one model for each definition) was studied using the C-statistic, the net reclassification index, or adjusted R2. Results The estimated prevalence of sarcopenia ranged from 3.3–20.0%. Only 85 participants (3.1%) were identified having sarcopenia according to all definitions. All definitions were, to some degree, associated with self-reported difficulties in physical function and knee extension strength, but none improved the predictive ability of the self-reported difficulties in physical function. Conversely, all definitions accounted for a small but significant amount of explained variation for predicting knee extension strength. Conclusions Prevalence of sarcopenia varies widely depending on the definition adopted. Based on this research, the current definitions for sarcopenia does not substantially increment the predictive value of clinical characteristics of patients to predict self-reported physical difficulties and knee extension strength. PMID:26136190

Suicide Risk Assessment Training for Psychology Doctoral Programs: Core Competencies and a Framework for Training

PubMed Central

Cramer, Robert J.; Johnson, Shara M.; McLaughlin, Jennifer; Rausch, Emilie M.; Conroy, Mary Alice

2014-01-01

Clinical and counseling psychology programs currently lack adequate evidence-based competency goals and training in suicide risk assessment. To begin to address this problem, this article proposes core competencies and an integrated training framework that can form the basis for training and research in this area. First, we evaluate the extent to which current training is effective in preparing trainees for suicide risk assessment. Within this discussion, sample and methodological issues are reviewed. Second, as an extension of these methodological training issues, we integrate empirically- and expert-derived suicide risk assessment competencies from several sources with the goal of streamlining core competencies for training purposes. Finally, a framework for suicide risk assessment training is outlined. The approach employs Objective Structured Clinical Examination (OSCE) methodology, an approach commonly utilized in medical competency training. The training modality also proposes the Suicide Competency Assessment Form (SCAF), a training tool evaluating self- and observer-ratings of trainee core competencies. The training framework and SCAF are ripe for empirical evaluation and potential training implementation. PMID:24672588

Suicide Risk Assessment Training for Psychology Doctoral Programs: Core Competencies and a Framework for Training.

PubMed

Cramer, Robert J; Johnson, Shara M; McLaughlin, Jennifer; Rausch, Emilie M; Conroy, Mary Alice

2013-02-01

Clinical and counseling psychology programs currently lack adequate evidence-based competency goals and training in suicide risk assessment. To begin to address this problem, this article proposes core competencies and an integrated training framework that can form the basis for training and research in this area. First, we evaluate the extent to which current training is effective in preparing trainees for suicide risk assessment. Within this discussion, sample and methodological issues are reviewed. Second, as an extension of these methodological training issues, we integrate empirically- and expert-derived suicide risk assessment competencies from several sources with the goal of streamlining core competencies for training purposes. Finally, a framework for suicide risk assessment training is outlined. The approach employs Objective Structured Clinical Examination (OSCE) methodology, an approach commonly utilized in medical competency training. The training modality also proposes the Suicide Competency Assessment Form (SCAF), a training tool evaluating self- and observer-ratings of trainee core competencies. The training framework and SCAF are ripe for empirical evaluation and potential training implementation.

ACR Appropriateness Criteria® Chronic Extremity Joint Pain-Suspected Inflammatory Arthritis.

PubMed

Jacobson, Jon A; Roberts, Catherine C; Bencardino, Jenny T; Appel, Marc; Arnold, Erin; Baccei, Steven J; Cassidy, R Carter; Chang, Eric Y; Fox, Michael G; Greenspan, Bennett S; Gyftopoulos, Soterios; Hochman, Mary G; Mintz, Douglas N; Newman, Joel S; Rosenberg, Zehava S; Shah, Nehal A; Small, Kirstin M; Weissman, Barbara N

2017-05-01

Evaluation for suspected inflammatory arthritis as a cause for chronic extremity joint pain often relies on imaging. This review first discusses the characteristic osseous and soft tissue abnormalities seen with inflammatory arthritis and how they may be imaged. It is essential that imaging results are interpreted in the context of clinical and serologic results to add specificity as there is significant overlap of imaging findings among the various types of arthritis. This review provides recommendations for imaging evaluation of specific types of inflammatory arthritis, including rheumatoid arthritis, seronegative spondyloarthropathy, gout, calcium pyrophosphate dihydrate disease (or pseudogout), and erosive osteoarthritis. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Utilizing Evaluation To Develop a Marketing Strategy in the Louisiana Cooperative Extension Service.

ERIC Educational Resources Information Center

Coreil, Paul D.; Verma, Satish

Marketing has become a popular strategic initiative among state extension services to meet the growing demand for program accountability. The Louisiana Cooperative Extension Service (LCES) began a formative evaluation of its marketing efforts as a step toward a comprehensive marketing plan. All extension faculty were surveyed to determine their…

Brief Report: An Independent Replication and Extension of Psychometric Evidence Supporting the Theory of Mind Inventory.

PubMed

Greenslade, Kathryn J; Coggins, Truman E

2016-08-01

This study presents an independent replication and extension of psychometric evidence supporting the Theory of Mind Inventory (ToMI). Parents of 20 children with ASD (4; 1-6; 7 years; months) and 20 with typical development (3; 1-6; 5), rated their child's theory of mind abilities in everyday situations. Other parent report and child behavioral assessments included the Social Responsiveness Scale-2, Vineland Adaptive Behavior Scales-2, Peabody Picture Vocabulary Test-4, and Clinical Evaluation of Language Fundamentals-Preschool, 2. Results revealed high internal consistency, expected developmental changes in children with typical development, expected group differences between children with and without ASD, and strong correlations with other measures of social and communication abilities. The ToMI demonstrates strong psychometrics, suggesting considerable utility in identifying theory of mind deficits in children with ASD.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea

2013-11-19

Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.

A biomechanical comparison of the Rogers interspinous and the Lovely-Carl tension band wiring techniques for fixation of the cervical spine.

PubMed

Brasil, A V; Coehlo, D G; Filho, T E; Braga, F M

2000-07-01

The authors conducted a biomechanical study in which they compared the uses of the Rogers interspinous and the Lovely-Carl tension band wiring techniques for internal fixation of the cervical spine. An extensive biomechanical evaluation (stiffness in positive and negative rotations around the x, y, and z axes; range of motion in flexion-extension, bilateral axial rotation, and bilateral bending; and neutral zone in flexion-extension, bilateral axial rotation, and lateral bending to the right and to the left) was performed in two groups of intact calf cervical spines. After these initial tests, all specimens were subjected to a distractive flexion Stage 3 ligamentous lesion. Group 1 specimens then underwent surgical fixation by the Rogers technique, and Group 2 specimens underwent surgery by using the Lovely-Carl technique. After fixation, specimens were again submitted to the same biomechanical evaluation. The percentage increase or decrease between the pre- and postoperative parameters was calculated. These values were considered quantitative indicators of the efficacy of the techniques, and the efficacy of the two techniques was compared. Analysis of the findings demonstrated that in the spines treated with the Lovely-Carl technique less restriction of movement was produced without affecting stiffness, compared with those treated with the Rogers technique, thus making the Lovely-Carl technique clinically less useful.

A literature review on anesthetic practice for carotid endarterectomy surgery based on cost, hemodynamic stability, and neurologic status.

PubMed

Meitzner, Mark C; Skurnowicz, Julie A; Mitchell, Anne

2007-06-01

An extensive literature review was undertaken to evaluate the best anesthetic practice for carotid endarterectomy surgery. Two anesthetic techniques were evaluated: general anesthetic with an endotracheal tube and regional anesthetic block. Three variables were reviewed with respect to significant clinical outcomes based on anesthetic technique. Relevant literature was obtained through multiple sources that included professional journals, a professional website, and textbooks. According to the literature, there is an advantage to performing regional anesthesia with respect to cost and neurologic status. Information analyzed was inconclusive with respect to hemodynamic stability and anesthetic technique. We conclude that regional anesthesia may have some slight advantages; however, more investigation is warranted.

RPE65 gene therapy slows cone loss in Rpe65-deficient dogs.

PubMed

Mowat, F M; Breuwer, A R; Bartoe, J T; Annear, M J; Zhang, Z; Smith, A J; Bainbridge, J W B; Petersen-Jones, S M; Ali, R R

2013-05-01

Recent clinical trials of retinal pigment epithelium gene (RPE65) supplementation therapy in Leber congenital amaurosis type 2 patients have demonstrated improvements in rod and cone function, but it may be some years before the effects of therapy on photoreceptor survival become apparent. The Rpe65-deficient dog is a very useful pre-clinical model in which to test efficacy of therapies, because the dog has a retina with a high degree of similarity to that of humans. In this study, we evaluated the effect of RPE65 gene therapy on photoreceptor survival in order to predict the potential benefit and limitations of therapy in patients. We examined the retinas of Rpe65-deficient dogs after RPE65 gene therapy to evaluate the preservation of rods and cone photoreceptor subtypes. We found that gene therapy preserves both rods and cones. While the moderate loss of rods in the Rpe65-deficient dog retina is slowed by gene therapy, S-cones are lost extensively and gene therapy can prevent that loss, although only within the treated area. Although LM-cones are not lost extensively, cone opsin mislocalization indicates that they are stressed, and this can be partially reversed by gene therapy. Our results suggest that gene therapy may be able to slow cone degeneration in patients if intervention is sufficiently early and also that it is probably important to treat the macula in order to preserve central function.

Measurement of segmental lumbar spine flexion and extension using ultrasound imaging.

PubMed

Chleboun, Gary S; Amway, Matthew J; Hill, Jesse G; Root, Kara J; Murray, Hugh C; Sergeev, Alexander V

2012-10-01

Clinical measurement, technical note. To describe a technique to measure interspinous process distance using ultrasound (US) imaging, to assess the reliability of the technique, and to compare the US imaging measurements to magnetic resonance imaging (MRI) measurements in 3 different positions of the lumbar spine. Segmental spinal motion has been assessed using various imaging techniques, as well as surgically inserted pins. However, some imaging techniques are costly (MRI) and some require ionizing radiation (radiographs and fluoroscopy), and surgical procedures have limited use because of the invasive nature of the technique. Therefore, it is important to have an easily accessible and inexpensive technique for measuring lumbar segmental motion to more fully understand spine motion in vivo, to evaluate the changes that occur with various interventions, and to be able to accurately relate the changes in symptoms to changes in motion of individual vertebral segments. Six asymptomatic subjects participated. The distance between spinous processes at each lumbar segment (L1-2, L2-3, L3-4, L4-5) was measured digitally using MRI and US imaging. The interspinous distance was measured with subjects supine and the lumbar spine in 3 different positions (resting, lumbar flexion, and lumbar extension) for both MRI and US imaging. The differences in distance from neutral to extension, neutral to flexion, and extension to flexion were calculated. The measurement methods had excellent reliability for US imaging (intraclass correlation coefficient [ICC3,3] = 0.94; 95% confidence interval: 0.85, 0.97) and MRI (ICC3,3 = 0.98; 95% confidence interval: 0.95, 0.99). The distance measured was similar between US imaging and MRI (P>.05), except at L3-4 flexion-extension (P = .003). On average, the MRI measurements were 1.3 mm greater than the US imaging measurements. This study describes a new method for the measurement of lumbar spine segmental flexion and extension motion using US imaging. The US method may offer an alternative to other imaging techniques to monitor clinical outcomes because of its ease of use and the consistency of measurements compared to MRI.

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

PubMed

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

2015-10-01

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

Increased Trunk Extension Endurance is Associated with Meaningful Improvement in Balance among Older Adults with Mobility Problems

PubMed Central

Suri, Pradeep; Kiely, Dan K.; Leveille, Suzanne G.; Frontera, Walter R.; Bean, Jonathan. F.

2011-01-01

Objective To determine if trunk extension endurance changes with training are associated with clinically meaningful improvements in balance among mobility-limited older adults. Design Longitudinal data from a randomized clinical trial. Setting Outpatient rehabilitation research center. Participants Community-dwelling older adults (N=64; mean age 75.9 y) with mobility limitations as defined by a score of 4 to 10 on the Short Physical Performance Battery. Interventions 16 weeks of progressive resistance training. Main Outcome Measures Outcomes were the Berg Balance Scale (BBS) and the Unipedal Stance Test (UST). Predictors included leg strength, leg power, trunk extension endurance and the product of heart rate and blood pressure (RPP) at the final stage of an exercise tolerance test. We performed an analysis of data from participants who completed 16 weeks of training using binary outcomes defined by a clinically meaningful change from baseline to completion of the intervention (CMC) (BBS= 4 units; UST= 5 seconds). The association of predictor variables with balance outcomes was examined separately and together in multivariate adjusted logistic regression models. Results Trunk extension endurance in seconds (1.04 [1.00– 1.09]) was independently associated with CMC on the BBS. Trunk extension endurance (1.02 [1.00– 1.03]) was independently associated with CMC on the UST. Other physical attributes were not associated with meaningful change in balance. Conclusions Improvements in trunk extension endurance were independently associated with clinically meaningful changes in balance in older adults. Leg strength, leg power, and RPP were not associated with CMC in balance. Poor trunk extension endurance may be a rehabilitative impairment worthy of further study as a modifiable factor linked to balance among older adults. PMID:21636073

Safety and efficacy of cladribine tablets in patients with relapsing-remitting multiple sclerosis: Results from the randomized extension trial of the CLARITY study.

PubMed

Giovannoni, Gavin; Soelberg Sorensen, Per; Cook, Stuart; Rammohan, Kottil; Rieckmann, Peter; Comi, Giancarlo; Dangond, Fernando; Adeniji, Abidemi K; Vermersch, Patrick

2017-08-01

In the 2-year CLARITY study, cladribine tablets significantly improved clinical and magnetic resonance imaging (MRI) outcomes (vs placebo) in patients with relapsing-remitting multiple sclerosis (MS). To assess the safety and efficacy of cladribine treatment in a 2-year Extension study. In this 2-year Extension study, placebo recipients from CLARITY received cladribine 3.5 mg/kg; cladribine recipients were re-randomized 2:1 to cladribine 3.5 mg/kg or placebo, with blind maintained. A total of 806 patients were assigned to treatment. Adverse event rates were generally similar between groups, but lymphopenia Grade ⩾ 3 rates were higher with cladribine than placebo (Grade 4 lymphopenia occurred infrequently). In patients receiving cladribine 3.5 mg/kg in CLARITY and experiencing lymphopenia Grade ⩾ 3 in the Extension, >90% of those treated with cladribine 3.5 mg/kg and all treated with placebo in the Extension, recovered to Grade 0-1 by study end. Cladribine treatment in CLARITY produced efficacy improvements that were maintained in patients treated with placebo in the Extension; in patients treated with cladribine 3.5 mg/kg in CLARITY, approximately 75% remained relapse-free when given placebo during the Extension. Cladribine tablets treatment for 2 years followed by 2 years' placebo treatment produced durable clinical benefits similar to 4 years of cladribine treatment with a low risk of severe lymphopenia or clinical worsening. No clinical improvement in efficacy was apparent following further treatment with cladribine tablets after the initial 2-year treatment period in this trial setting.

Evaluation of Faculty Performance in Extension and Service. AIR 1989 Annual Forum Paper.

ERIC Educational Resources Information Center

Montgomery, James R.; And Others

A widespread perception exists that faculty with public service or extension activities are not treated equitably either in annual evaluations for merit salary increases or in peer evaluation for promotion. To determine the items considered important in making personnel decisions in extension and service areas, a survey was sent to chief academic…

The Role of Evaluation in Determining the Public Value of Extension

ERIC Educational Resources Information Center

Franz, Nancy; Arnold, Mary; Baughman, Sarah

2014-01-01

Extension has developed a strong evaluation culture across the system for the last 15 years. Yet measures are still limited to the private value of programs, looking at problems in a linear way and at isolated efforts. Across the country, Extension evaluators and administrators need to step up to help answer the "so what?" question about…

Recovery from distal ulnar motor conduction block injury: serial EMG studies.

PubMed

Montoya, Liliana; Felice, Kevin J

2002-07-01

Acute conduction block injuries often result from nerve compression or trauma. The temporal pattern of clinical, electrophysiologic, and histopathologic changes following these injuries has been extensively studied in experimental animal models but not in humans. Our recent evaluation of a young man with an injury to the deep motor branch of the ulnar nerve following nerve compression from weightlifting exercises provided the opportunity to follow the course and recovery of a severe conduction block injury with sequential nerve conduction studies. The conduction block slowly and completely resolved, as did the clinical deficit, over a 14-week period. The reduction in conduction block occurred at a linear rate of -6.1% per week. Copyright 2002 Wiley Periodicals, Inc.

[Severe complications after non-intended usage of octenidine dihydrochloride. A case series with four dogs].

PubMed

Kaiser, S; Kramer, M; Thiel, C

2015-01-01

Case series of four dogs in which extensive bite wounds had been treated using octenidine dihydrochloride (Octenivet® or Octenisept®) flushing. The dogs subsequently developed severe local complications. Retrospective evaluation of clinical symptoms, diagnostics, therapy and course of the disease. In four dogs, severe necrosis and persistent edematous changes of the treated area developed after the application of octenidine dihydrochloride. The clinical course was comparable to complications described previously in human medicine. Therapy was protracted and complicated by secondary wound infection. Irrigation of deep wounds, particularly bite wounds, using octenidine dihydrochloride without drainage may lead to persistent edematous changes, inflammatory reactions and necrosis. The inappropriate application of octenidine dihydrochloride for wound irrigation should be avoided in veterinary medicine.

Differential involvement of forearm muscles in ALS does not relate to sonographic structural nerve alterations.

PubMed

Schreiber, Stefanie; Schreiber, Frank; Debska-Vielhaber, Grazyna; Garz, Cornelia; Hensiek, Nathalie; Machts, Judith; Abdulla, Susanne; Dengler, Reinhard; Petri, Susanne; Nestor, Peter J; Vielhaber, Stefan

2018-07-01

We aimed to assess whether differential peripheral nerve involvement parallels dissociated forearm muscle weakness in amyotrophic lateral sclerosis (ALS). The analysis comprised 41 ALS patients and 18 age-, sex-, height- and weight-matched healthy controls. Strength of finger-extension and -flexion was measured using the Medical Research Council (MRC) scale. Radial, median and ulnar nerve sonographic cross-sectional area (CSA) and echogenicity, expressed by the hypoechoic fraction (HF), were determined. In ALS, finger extensors were significantly weaker than finger flexors. Sonographic evaluation revealed peripheral nerve atrophy, affecting various nerve segments in ALS. HF was unaltered. This systematic study confirmed a long-observed physical examination finding in ALS - weakness in finger-extension out of proportion to finger-flexion. This phenomenon was not related to any particular sonographic pattern of upper limb peripheral nerve alteration. In ALS, dissociated forearm muscle weakness could aid in the disease's diagnosis. Nerve ultrasound did not provide additional information on the differential involvement of finger-extension and finger-flexion strength. Copyright © 2018 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Assessment of Visual Reliance in Balance Control: An Inexpensive Extension of the Static Posturography.

PubMed

Púčik, Jozef; Šaling, Marián; Lukáč, Tomáš; Ondráček, Oldřich; Kucharík, Martin

2014-01-01

Ability of humans to maintain balance in an upright stance and during movement activities is one of the most natural skills affecting everyday life. This ability progressively deteriorates with increasing age, and balance impairment, often aggravated by age-related diseases, can result in falls that adversely impact the quality of life. Falls represent serious problems of health concern associated with aging. Many investigators, involved in different science disciplines such as medicine, engineering, psychology, and sport, have been attracted by a research of the human upright stance. In a clinical practice, stabilometry based on the force plate is the most widely available procedure used to evaluate the balance. In this paper, we have proposed a low-cost extension of the conventional stabilometry by the multimedia technology that allows identifying potentially disturbing effects of visual sensory information. Due to the proposed extension, a stabilometric assessment in terms of line integral of center of pressure (COP) during moving scene stimuli shows higher discrimination power between young healthy and elderly subjects with supposed stronger visual reliance.

Assessment of Visual Reliance in Balance Control: An Inexpensive Extension of the Static Posturography

PubMed Central

Púčik, Jozef; Šaling, Marián; Lukáč, Tomáš; Ondráček, Oldřich; Kucharík, Martin

2014-01-01

Ability of humans to maintain balance in an upright stance and during movement activities is one of the most natural skills affecting everyday life. This ability progressively deteriorates with increasing age, and balance impairment, often aggravated by age-related diseases, can result in falls that adversely impact the quality of life. Falls represent serious problems of health concern associated with aging. Many investigators, involved in different science disciplines such as medicine, engineering, psychology, and sport, have been attracted by a research of the human upright stance. In a clinical practice, stabilometry based on the force plate is the most widely available procedure used to evaluate the balance. In this paper, we have proposed a low-cost extension of the conventional stabilometry by the multimedia technology that allows identifying potentially disturbing effects of visual sensory information. Due to the proposed extension, a stabilometric assessment in terms of line integral of center of pressure (COP) during moving scene stimuli shows higher discrimination power between young healthy and elderly subjects with supposed stronger visual reliance. PMID:27006930

Superior Vena Cava as Gateway to Heart: Metastatic Breast Carcinoma Causing Ball in a Loop Metastasis to Right Atrium.

PubMed

Sandhu, Harpreet Singh; Mahendrakar, Sampath Kumar Mahadevappa; Ladhani, Sulaiman Sadruddin; Khan, Azizullah Hafizullah; Loya, Yunus Shafi

2017-07-01

Breast carcinoma is the most common invasive cancer in women worldwide. It metastasizes commonly to bone, lungs, regional lymph nodes and brain. Cardiac metastasis of lung and breast cancers is a known but rare complication of advanced disease with tumour metastasising to pericardium via the locoregional lymphatic system. Here we present a case of 59-year-old female presenting with right upper limb oedema, facial puffiness and features of Superior Vena Cava (SVC) syndrome 15 years after mastectomy and adjuvant chemotherapy, radiotherapy for carcinoma of the right breast. Further evaluation revealed extensive thrombus invading the right internal jugular vein, subclavian vein, SVC with intraluminal extension into right atrium causing ball in a loop obstruction at tricuspid valve. Whole body Positron emission tomography scan confirmed the diagnosis of extensive metastatic disease and patient was managed on palliative therapy. Haematogenous spread and intraluminal growth of metastatic deposits from breast carcinoma 15 years ago is rare and clinical presentation as SVC obstruction has not been reported in our review of literature.

Optimization and validation of an existing, surgical and robust dry eye rat model for the evaluation of therapeutic compounds.

PubMed

Joossen, Cedric; Lanckacker, Ellen; Zakaria, Nadia; Koppen, Carina; Joossens, Jurgen; Cools, Nathalie; De Meester, Ingrid; Lambeir, Anne-Marie; Delputte, Peter; Maes, Louis; Cos, Paul

2016-05-01

The aim of this research was to optimize and validate an animal model for dry eye, adopting clinically relevant evaluation parameters. Dry eye was induced in female Wistar rats by surgical removal of the exorbital lacrimal gland. The clinical manifestations of dry eye were evaluated by tear volume measurements, corneal fluorescein staining, cytokine measurements in tear fluid, MMP-9 mRNA expression and CD3(+) cell infiltration in the conjunctiva. The animal model was validated by treatment with Restasis(®) (4 weeks) and commercial dexamethasone eye drops (2 weeks). Removal of the exorbital lacrimal gland resulted in 50% decrease in tear volume and a gradual increase in corneal fluorescein staining. Elevated levels of TNF-α and IL-1α have been registered in tear fluid together with an increase in CD3(+) cells in the palpebral conjunctiva when compared to control animals. Additionally, an increase in MMP-9 mRNA expression was recorded in conjunctival tissue. Reference treatment with Restasis(®) and dexamethasone eye drops had a positive effect on all evaluation parameters, except on tear volume. This rat dry eye model was validated extensively and judged appropriate for the evaluation of novel compounds and therapeutic preparations for dry eye disease. Copyright © 2016 Elsevier Ltd. All rights reserved.

What is the benefit of treatment with multiple lines of chemotherapy for patients with metastatic breast cancer? A retrospective cohort study.

PubMed

Bakker, J L; Wever, K; van Waesberghe, J H; Beeker, A; Meijers-Heijboer, H; Konings, I R; Verheul, H M W

2015-12-01

Despite the extensive clinical experience, it is still under debate to what extent patients with metastatic breast cancer (MBC) benefit from multiple lines of chemotherapy beyond standard first or second line treatment. Selection of patients with MBC who will benefit from treatment is crucial to improve outcome and reduce unnecessary toxicity. In this retrospective study, systemic treatment outcome for patients with metastatic MBC is being evaluated. We evaluated to what extent the clinical benefit of prior chemotherapy can predict the success of a subsequent treatment line. Ninety-one patients treated with chemotherapy for MBC between January 2005 and January 2009 were included in this study. Clinical characteristics of patients, choices of chemotherapy and response at first evaluation of every treatment line was evaluated based on radiologic and clinical data. Patients received multiple systemic cytotoxic and biological (combination) therapies. 30% of these patients received more than five consecutive systemic (combination) treatments. First line chemotherapy was mostly anthracycline-based, followed by taxanes, capecitabine and vinorelbine. The response rate (RR, complete response plus partial response according to RECIST 1.1) decreased from 20% (95% CI 11-28%) upon first line of treatment to 0% upon the fourth line. The clinical benefit rate (combining RR and stable disease) decreased from 85% (95% CI 78-93%) in the first to 54% (95% CI 26-67) upon the fourth line. 24% of the patients with clinical benefit at first evaluation did not receive a subsequent line of treatment when progressive disease occurred, while sixty-one percent of the patients with progressive disease at first evaluation of a treatment did not receive a subsequent line of chemotherapy. When applied, the efficacy of a subsequent line of treatment was similar for patients independent of previous treatment benefit. The clinical benefit at first evaluation from systemic treatment in MBC does not predict for subsequent treatment benefit in this retrospective analysis. The fact that 61% of patients did not receive subsequent treatment after previous treatment failure suggests that either clinical judgement is of critical value in selection of patients to prevent them from unnecessary toxicity or, alternatively indicates that based on the assumption that prior treatment failure predicts for lack of benefit undertreatment of patients occurs. Therefore, a more adequate clinical judgement tool or predictive biomarkers for response are urgently needed to improve treatment outcome. Copyright © 2015. Published by Elsevier Ltd.

Parkinson's Disease Diagnostic Observations (PADDO): study rationale and design of a prospective cohort study for early differentiation of parkinsonism.

PubMed

van Rumund, Anouke; Aerts, Marjolein B; Esselink, Rianne A J; Meijer, Frederick J A; Verbeek, Marcel M; Bloem, Bastiaan R

2018-05-16

Differentiation of Parkinson's disease (PD) from the various types of atypical parkinsonism (AP) such as multiple system atrophy (MSA), progressive supranuclear palsy (PSP), dementia with Lewy bodies (DLB), corticobasal syndrome (CBS) and vascular parkinsonism (VP), can be challenging, especially early in the disease course when symptoms overlap. A major unmet need in the diagnostic workup of these disorders is a diagnostic tool that differentiates the various disorders, preferably in the earliest disease stages when the clinical presentation is similar. Many diagnostic tests have been evaluated, but their added value was studied mostly in retrospective case-control studies that included patients with a straightforward clinical diagnosis. Here, we describe the design of a prospective cohort study in patients with parkinsonism in an early disease stage who have an uncertain clinical diagnosis. Our aim is to evaluate the diagnostic accuracy of (1) detailed clinical examination by a movement disorder specialist, (2) magnetic resonance imaging (MRI) techniques and (3) cerebrospinal fluid (CSF) biomarkers. Patients with parkinsonism with an uncertain clinical diagnosis and a disease course less than three years will be recruited. Patients will undergo extensive neurological examination, brain MRI including conventional and advanced sequences, and a lumbar puncture. The diagnosis (including level of certainty) will be defined by a movement disorders expert, neuroradiologist and neurochemist based on clinical data, MRI results and CSF results, respectively. The clinical diagnosis after three years' follow-up will serve as the "gold standard" reference diagnosis, based on consensus criteria and as established by two movement disorder specialists (blinded to the test results). Diagnostic accuracy of individual instruments and added value of brain MRI and CSF analysis after evaluation by a movement disorder expert will be calculated, expressed as the change in percentage of individuals that are correctly diagnosed with PD or AP. This study will yield new insights into the diagnostic value of clinical evaluation by a movement disorder specialist, brain MRI and CSF analysis in discriminating PD from AP in early disease stages. The outcome has the potential to help clinicians in choosing the optimal diagnostic strategy for patients with an uncertain clinical diagnosis. NCT01249768, registered November 26 2010.

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study.

PubMed

Brosteanu, Oana; Schwarz, Gabriele; Houben, Peggy; Paulus, Ursula; Strenge-Hesse, Anke; Zettelmeyer, Ulrike; Schneider, Anja; Hasenclever, Dirk

2017-12-01

Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%-99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is -0.04 on the logit scale with two-sided 95% confidence interval (-0.40; 0.33), demonstrating that risk-adapted monitoring is non-inferior to extensive on-site monitoring. At most, extensive on-site monitoring could reduce the frequency of major Good Clinical Practice findings by 8.2% compared with risk-adapted monitoring. Conclusion Compared with risk-adapted monitoring, the potential benefit of extensive on-site monitoring is small relative to overall finding rates, although risk-adapted monitoring requires less than 50% of extensive on-site monitoring resources. Clusters of findings within trials suggest that complicated, overly specific or not properly justified protocol requirements contributed to the overall frequency of findings. Risk-adapted monitoring in only a sample of patients appears sufficient to identify systematic problems in the conduct of clinical trials. Risk-adapted monitoring has a part to play in quality control. However, no monitoring strategy can remedy defects in quality of design. Monitoring should be embedded in a comprehensive quality management approach covering the entire trial lifecycle.

Risk-adapted monitoring is not inferior to extensive on-site monitoring: Results of the ADAMON cluster-randomised study

PubMed Central

Brosteanu, Oana; Schwarz, Gabriele; Houben, Peggy; Paulus, Ursula; Strenge-Hesse, Anke; Zettelmeyer, Ulrike; Schneider, Anja; Hasenclever, Dirk

2017-01-01

Background According to Good Clinical Practice, clinical trials must protect rights and safety of patients and make sure that the trial results are valid and interpretable. Monitoring on-site has an important role in achieving these objectives; it controls trial conduct at trial sites and informs the sponsor on systematic problems. In the past, extensive on-site monitoring with a particular focus on formal source data verification often lost sight of systematic problems in study procedures that endanger Good Clinical Practice objectives. ADAMON is a prospective, stratified, cluster-randomised, controlled study comparing extensive on-site monitoring with risk-adapted monitoring according to a previously published approach. Methods In all, 213 sites from 11 academic trials were cluster-randomised between extensive on-site monitoring (104) and risk-adapted monitoring (109). Independent post-trial audits using structured manuals were performed to determine the frequency of major Good Clinical Practice findings at the patient level. The primary outcome measure is the proportion of audited patients with at least one major audit finding. Analysis relies on logistic regression incorporating trial and monitoring arm as fixed effects and site as random effect. The hypothesis was that risk-adapted monitoring is non-inferior to extensive on-site monitoring with a non-inferiority margin of 0.60 (logit scale). Results Average number of monitoring visits and time spent on-site was 2.1 and 2.7 times higher in extensive on-site monitoring than in risk-adapted monitoring, respectively. A total of 156 (extensive on-site monitoring: 76; risk-adapted monitoring: 80) sites were audited. In 996 of 1618 audited patients, a total of 2456 major audit findings were documented. Depending on the trial, findings were identified in 18%–99% of the audited patients, with no marked monitoring effect in any of the trials. The estimated monitoring effect is −0.04 on the logit scale with two-sided 95% confidence interval (−0.40; 0.33), demonstrating that risk-adapted monitoring is non-inferior to extensive on-site monitoring. At most, extensive on-site monitoring could reduce the frequency of major Good Clinical Practice findings by 8.2% compared with risk-adapted monitoring. Conclusion Compared with risk-adapted monitoring, the potential benefit of extensive on-site monitoring is small relative to overall finding rates, although risk-adapted monitoring requires less than 50% of extensive on-site monitoring resources. Clusters of findings within trials suggest that complicated, overly specific or not properly justified protocol requirements contributed to the overall frequency of findings. Risk-adapted monitoring in only a sample of patients appears sufficient to identify systematic problems in the conduct of clinical trials. Risk-adapted monitoring has a part to play in quality control. However, no monitoring strategy can remedy defects in quality of design. Monitoring should be embedded in a comprehensive quality management approach covering the entire trial lifecycle. PMID:28786330

Does the Genetic Cause of Prader-Willi Syndrome Explain the Highly Variable Phenotype?

PubMed

Dobrescu, Andreea-Iulia; Chirita-Emandi, Adela; Andreescu, Nicoleta; Farcas, Simona; Puiu, Maria

2016-09-01

Prader-Willi syndrome (PWS) is characterized by extensive clinical and genetic variability caused by lack of expression of imprinted genes of the chromosomal region 15q11.2-q13. The genotye-phenotype correlation has not been yet fully elucidated. To analyze these correlations in order to determine the role of specifi c geneic alterations in the development of clinical symptoms in PWS. We retrospectively analyzed data routinely collected as part of the clinical care of 52 patients with clinical suspicion of PWS. FISH test was performed in all patients; in case of negative results, methylation test was performed. PWS was confi rmed in 35 patients that were divided in two groups according to the genetic cause of PWS: group A-21 patients with 15q11-q13 region deletion, mean age at evaluation 8.1 years (SD= 5.6) and mean of clinical score 9.4 ± 1.8; group B-14 patients with positive methylation test, with mean age at evaluation 6.7 years (SD= 4.6) and mean of clinical score 10.1 ± 1.9. Facial dysmorphism and neonatal hypotonia were present in all evaluated patients; while, higher frequency of major and minor PWS criteria were noted in the group A. Onset of hyperphagia, was around the age of 2 years in most patients, however one patient from group B had normal eating behavior and normal weight beyond age 5 years. In our study, the various genotypes did not seem to explain the diff erence in phenotype in PWS patients. We found a delayed time until diagnosis in these patients, although all had neonatal hypotonia and other suggestive phenotypic features, underlining once more the need for increased awareness of this syndrome, as well as easier accessibility to genetic counseling.

Advancing the integration of hospital IT. Pitfalls and perspectives when replacing specialized software for high-risk environments with enterprise system extensions.

PubMed

Engelmann, Carsten; Ametowobla, Dzifa

2017-05-17

Planning and controlling surgical operations hugely impacts upon productivity, patient safety, and surgeons' careers. Established, specialized software for this task is being increasingly replaced by "Operating Room (OR)-modules" appended to enterprise-wide resource planning (ERP) systems. As a result, usability problems are re-emerging and require developers' attention. Systematic evaluation of the functionality and social repercussions of a global, market-leading IT business control system (SAP R3, Germany), adapted for real-time OR process steering. Field study involving document analyses, interviews, and a 73-item survey addressed to 77 qualified (> 1-year system experience) senior planning executives (end users; "planners") working in surgical departments of university hospitals. Planners reported that 57% of electronic operation requests contained contradictory information. Key screens contained clinically irrelevant areas (36 +/- 29%). Compared to the legacy system, users reported either no improvements or worse performance, in regard to co-ordination of OR stakeholders, intra-day program changes, and safety. Planners concluded that the ERP-planning module was "non-intuitive" (66%), increased planning work (56%, p=0.002), and did not impact upon either organizational mishap spectrum or frequency. Interviews evidenced intra-institutional power shifts due to increased system complexity. Planners resented e.g. a trend towards increased personal culpability for mishap. Highly complex enterprise system extensions may not be directly suited to specific process steering tasks in a high risk/low error-environment like the OR. In view of surgeons' high primary task load, the repeated call for simpler IT is an imperative for ERP extensions. System design should consider a) that current OR IT suffers from an input limitation regarding planning-relevant real-time data, and b) that there are social processes that strongly affect planning and particularly ERP use beyond algorithms. Real improvement of clinical IT tools requires their independent evaluation according to standards developed for pharmaceutical subjects.

Complementary and alternative medicine for childhood asthma: an overview of evidence and patents.

PubMed

Hon, Kam-Lun E; Fung, Ching Ki; Leung, Alexander K C; Leung, Theresa Ngan-Ho; Ng, Daniel K K

2015-01-01

Asthma is a prevalent childhood atopic disease associated with significant impairment of quality of life. Management relies on avoidance of triggers such as food and aeroallergens, the use of inhaled bronchodilators/corticosteroids and anti-allergic or immune-modulating therapies. Inhaled corticosteroids (ICSs) and bronchodilators have been the mainstay of treatment. In China as well as throughout Asia, myths and misconceptions on western medicine and corticosteroids are prevalent and result in non-adherence of treatment. A wide variety of complementary and alternative medicines (CAM) are available. Some of these have undergone extensive clinical trials and have been documented to have some therapeutic effects on asthma. Nevertheless, the majority of these treatment modalities is not efficacious and may even be detrimental. This article overviews the evidence for the clinical efficacy of all major CAM modalities. Despite CAM modalities are extensively used by the patients with asthma, very few CAM patents are available. This article also discusses recent patents pertinent to asthma. Only a few patents on herbal medicine for asthma have been evaluated but therapeutic efficacy is not substantially documented. Parents seeking CAM for asthma must consult qualified registered practitioners before using it.

SURGICAL TREATMENT OF DISTAL RADIUS FRACTURES WITH A VOLAR LOCKED PLATE: CORRELATION OF CLINICAL AND RADIOGRAPHIC RESULTS

PubMed Central

Xavier, Claudio Roberto Martins; Dal Molin, Danilo Canesin; dos Santos, Rafael Mota Marins; dos Santos, Roberto Della Torre; Neto, Julio Cezar Ferreira

2015-01-01

Objectives: To analyze and correlate the clinical and radiographic results from patients with distal radius fractures who underwent surgical treatment with a fixed-angle volar locked plate. Methods: Sixty-four patients with distal radius fractures were evaluated. They all underwent surgical treatment with a volar locked plate for the distal radius, with a minimum of six months of postoperative follow-up. They underwent a physical examination that measured range of motion and grip strength, answered the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire and underwent radiographic examination. Results: In the physical examination on the patients, all the range-of-motion measurements were reduced. Grip strength measured in kgf was on average 85.8% of the strength on the unaffected side. The mean DASH score was 15.99. A significant relationship was found between lower DASH scores and losses of extension and grip strength. On the radiographs, the mean values in relation to the unfractured side were 84.0% for radial inclination, 85.4% for radial length and 86.8% for volar deviation of the radius. Loss of radial length was correlated with losses of extension and grip strength. PMID:27027046

Clinical Named Entity Recognition Using Deep Learning Models.

PubMed

Wu, Yonghui; Jiang, Min; Xu, Jun; Zhi, Degui; Xu, Hua

2017-01-01

Clinical Named Entity Recognition (NER) is a critical natural language processing (NLP) task to extract important concepts (named entities) from clinical narratives. Researchers have extensively investigated machine learning models for clinical NER. Recently, there have been increasing efforts to apply deep learning models to improve the performance of current clinical NER systems. This study examined two popular deep learning architectures, the Convolutional Neural Network (CNN) and the Recurrent Neural Network (RNN), to extract concepts from clinical texts. We compared the two deep neural network architectures with three baseline Conditional Random Fields (CRFs) models and two state-of-the-art clinical NER systems using the i2b2 2010 clinical concept extraction corpus. The evaluation results showed that the RNN model trained with the word embeddings achieved a new state-of-the- art performance (a strict F1 score of 85.94%) for the defined clinical NER task, outperforming the best-reported system that used both manually defined and unsupervised learning features. This study demonstrates the advantage of using deep neural network architectures for clinical concept extraction, including distributed feature representation, automatic feature learning, and long-term dependencies capture. This is one of the first studies to compare the two widely used deep learning models and demonstrate the superior performance of the RNN model for clinical NER.

Clinical Named Entity Recognition Using Deep Learning Models

PubMed Central

Wu, Yonghui; Jiang, Min; Xu, Jun; Zhi, Degui; Xu, Hua

2017-01-01

Clinical Named Entity Recognition (NER) is a critical natural language processing (NLP) task to extract important concepts (named entities) from clinical narratives. Researchers have extensively investigated machine learning models for clinical NER. Recently, there have been increasing efforts to apply deep learning models to improve the performance of current clinical NER systems. This study examined two popular deep learning architectures, the Convolutional Neural Network (CNN) and the Recurrent Neural Network (RNN), to extract concepts from clinical texts. We compared the two deep neural network architectures with three baseline Conditional Random Fields (CRFs) models and two state-of-the-art clinical NER systems using the i2b2 2010 clinical concept extraction corpus. The evaluation results showed that the RNN model trained with the word embeddings achieved a new state-of-the- art performance (a strict F1 score of 85.94%) for the defined clinical NER task, outperforming the best-reported system that used both manually defined and unsupervised learning features. This study demonstrates the advantage of using deep neural network architectures for clinical concept extraction, including distributed feature representation, automatic feature learning, and long-term dependencies capture. This is one of the first studies to compare the two widely used deep learning models and demonstrate the superior performance of the RNN model for clinical NER. PMID:29854252

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

Intravascular ultrasound for intracranial angioplasty and stent placement: technical case report.

PubMed

Wehman, J Christopher; Holmes, David R; Hanel, Ricardo A; Levy, Elad I; Hopkins, L Nelson

2006-10-01

Intravascular ultrasound (IVUS) imaging has been used extensively in coronary artery interventions and has provided invaluable information for the understanding and treatment of coronary arterial disease. We present here the first description, to our knowledge, of IVUS-guided intracranial arterial interventions in the clinical setting. Two patients underwent intracranial angioplasty and stent placement with the assistance of IVUS for the evaluation of their lesions. One patient underwent stenting to treat an occlusive dissection of the left internal carotid artery that occurred during arteriovenous malformation embolization. Another patient underwent angioplasty and stenting for high-grade restenosis of a basilar artery atherosclerotic lesion. Both patients underwent successful revascularization procedures. The patient with the dissection had a small intraventricular and parenchymal hemorrhage documented by computed tomography 4 hours after treatment, but did not develop hydrocephalus or further hemorrhage. Both patients did well clinically and had no permanent neurological deficits. IVUS provided important information in terms of lesion evaluation, stent selection, and stent placement in each case. IVUS of the intracranial circulation may assist the performance of intracranial angioplasty and stenting. It provides useful information that can affect clinical decisions. It may prove to be a valuable tool in clinical use and enhance our understanding of vascular disease of the intracranial circulation, as it has in the coronary circulation.

Use of a nitinol stent to palliate a colorectal neoplastic obstruction in a dog

PubMed Central

Culp, William T. N.; MacPhail, Catriona M.; Perry, James A.; Jensen, Tracey D.

2015-01-01

Case Description A 12-year-old castrated male Labrador Retriever was evaluated for clinical signs associated with colorectal obstruction. Clinical Findings The dog had a 2-week history of tenesmus and hematochezia. On rectal examination, an annular colorectal mass was palpable extending orad into the pelvic canal. The original diagnosis of the colorectal mass was a mucosal adenoma. The dog was maintained on a low-residue diet and fecal softeners for a period of 13 months after initial diagnosis. At that time, medical management was no longer effective. Treatment and Outcome Placement of a colonic stent was chosen to palliate the clinical signs associated with colorectal obstruction. By use of fluoroscopic and colonoscopic guidance, a nitinol stent was placed intraluminally to open the obstructed region. Placement of the stent resulted in improvement of clinical signs, although tenesmus and obstipation occurred periodically after stent placement. At 212 days after stent placement, the patient had extensive improvement in clinical signs with minimal complications; however, clinical signs became severe at 238 days after stent placement, and the dog was euthanized. Histologic evaluation of the rectal tumor from samples obtained during necropsy revealed that the tumor had undergone malignant transformation to a carcinoma in situ. Clinical Relevance A stent was successfully placed in the colon and rectum to relieve obstruction associated with a tumor originally diagnosed as a benign neoplasm. Placement of colorectal stents may be an option for the palliation of colorectal obstruction secondary to neoplastic disease; however, clinical signs may persist, and continuation of medical management may be necessary. PMID:21756178

Evaluation of the Clinical LOINC (Logical Observation Identifiers, Names, and Codes) Semantic Structure as a Terminology Model for Standardized Assessment Measures

PubMed Central

Bakken, Suzanne; Cimino, James J.; Haskell, Robert; Kukafka, Rita; Matsumoto, Cindi; Chan, Garrett K.; Huff, Stanley M.

2000-01-01

Objective: The purpose of this study was to test the adequacy of the Clinical LOINC (Logical Observation Identifiers, Names, and Codes) semantic structure as a terminology model for standardized assessment measures. Methods: After extension of the definitions, 1,096 items from 35 standardized assessment instruments were dissected into the elements of the Clinical LOINC semantic structure. An additional coder dissected at least one randomly selected item from each instrument. When multiple scale types occurred in a single instrument, a second coder dissected one randomly selected item representative of each scale type. Results: The results support the adequacy of the Clinical LOINC semantic structure as a terminology model for standardized assessments. Using the revised definitions, the coders were able to dissect into the elements of Clinical LOINC all the standardized assessment items in the sample instruments. Percentage agreement for each element was as follows: component, 100 percent; property, 87.8 percent; timing, 82.9 percent; system/sample, 100 percent; scale, 92.6 percent; and method, 97.6 percent. Discussion: This evaluation was an initial step toward the representation of standardized assessment items in a manner that facilitates data sharing and re-use. Further clarification of the definitions, especially those related to time and property, is required to improve inter-rater reliability and to harmonize the representations with similar items already in LOINC. PMID:11062226

Retrospective Review of Student Research Projects in a Canadian Master of Science in Physical Therapy Programme and the Perceived Impact on Advisors' Research Capacity, Education, Clinical Practice, Knowledge Translation, and Health Policy.

PubMed

Lacey, Courtney; Scodras, Stephanie; Ardron, Julie; Sellan, Ryan; Garbaczewska, Martyna; O'Brien, Kelly K; Salbach, Nancy M

2018-01-01

Purpose: This study's aim was to characterize the nature of students' research conducted for a Master of Science in Physical Therapy (MScPT) degree programme at a Canadian university and evaluate the lead advisors' perspectives of its impact on their research capacity, education, clinical practice, knowledge translation, and health policy. Methods: We conducted a quantitative, cross-sectional, retrospective review of research reports from 2003 to 2014 to characterize the MScPT students' research and a quantitative, cross-sectional e-survey of lead research advisors to evaluate the impact of this research. Results: Data were abstracted from reports of 201 research projects completed between 2003 and 2014. Projects were conducted primarily in university-affiliated hospitals (41.6%) or the university's physical therapy department (41.1%), and the majority (52.5%) had a clinical focus. Of the 95 lead advisors of 201 projects, 59 advisors (response rate 62.1%) of 119 projects completed the survey questionnaire. The respondents most frequently identified clinical practice (45.1%) and advisors' research capacity (31.4%) as areas positively affected by the students' research. Conclusions: The MScPT students' research projects facilitate the conduct of extensive research internally and across affiliated hospitals. This research appears to advance not only clinical practice but also the ability of lead advisors to undertake research.

Proteomic evaluation of milk from different mammalian species as a substitute for breast milk.

PubMed

D'Auria, Enza; Agostoni, Carlo; Giovannini, Marcello; Riva, Enrica; Zetterström, Rolf; Fortin, Riccardo; Greppi, Gian Franco; Bonizzi, Luigi; Roncada, Paola

2005-12-01

As milk represents the main source of nutrition for infants, the question of an effective human milk substitute becomes mandatory when a formula-fed baby is allergic to cows' milk proteins. In this case, formulas containing extensively hydrolysed milk proteins should be preferred, but even such a formula may cause allergic reactions in highly sensitive patients. If there is evidence of cows' milk allergy with IgE-associated symptoms, after 6 mo of age, a soy bean formula may be recommended only when tolerance to soy protein has been established by clinical challenge. In infants with allergic reactions to cows' milk proteins, even after extensive hydrolyzation, proteomic techniques coupled to immunological methods may make it possible to select other milk products that do not contain the same allergens as ordinary cow's milk. In this paper, evidence will be presented that proteomic evaluation of proteins from different mammalian species may be a suitable method of testing whether proteins from the milk of different mammalian species may be used as a substitute for untreated bovine milk. Proteomic evaluation of milk from different mammalian species may not only be of help when recommending suitable feeding in cases of cows' milk allergy but also gives new insight into the background to allergic reactions caused by milk proteins.

The full metallic double-pigtail ureteral stent: Review of the clinical outcome and current status

PubMed Central

Kallidonis, Panagiotis S.; Georgiopoulos, Ioannis S.; Kyriazis, Iason D.; Kontogiannis, Stavros; Al-Aown, Abdulrahman M.; Liatsikos, Evangelos N.

2015-01-01

The full metallic double-J ureteral stent (MS) was introduced as a method for providing long-term drainage in malignant ureteral obstruction. Experimental evaluation of the MS revealed that its mechanical features allow efficient drainage in difficult cases, which could not be managed by the insertion of a standard polymeric double-J stent. Clinical experience with the MS showed controversial results. Careful patient selection results in efficient long-term management of malignant ureteral obstruction. The use of the MS should also be considered in selected benign cases. Major complications are uncommon and the minor complications should not hinder its use. Experience in pediatric patients is limited and warrants additional study. The cost-effectiveness of the MS seems to be appropriate for long-term treatment. Further investigation with comparative clinical trials would document the outcome more extensively and establish the indications as well as the selection criteria for the MS. PMID:25624569

Ultrasonographic vascular mechanics to assess arterial stiffness: a review.

PubMed

Teixeira, Rogério; Vieira, Maria João; Gonçalves, Alexandra; Cardim, Nuno; Gonçalves, Lino

2016-03-01

In recent years, the role of arterial stiffness in the development of cardiovascular diseases has been explored more extensively. Local arterial stiffness may be gauged via ultrasound, measuring pulse transit time relative to changing vessel diameters and distending pressures. Recently, direct vessel-wall tracking systems have been devised based on new ultrasonographic methodologies, such as tissue Doppler imaging and speckle-tracking analysis--vascular mechanics. These advances have been evaluated in varying arterial distributions, are proved surrogates of pulse wave velocity, and are ascending in clinical importance. In the course of this review, we describe fundamental concepts and methodologies involved in ultrasound assessment of vascular mechanics. We also present relevant clinical studies and discuss the potential clinical utility of such diagnostic pursuits. Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

[Interdisciplinary longitudinal curriculum "Medical psychology, psychotherapy and psychosomatics" (MPPP) at the University of Ulm].

PubMed

Allert, Gebhard; Gommel, Michael; Tamulionyté, Liudvika; Appelt, Matthias; Zenz, Helmuth; Kächele, Horst

2002-08-01

We report the clinical part of the longitudinal curriculum MPPP which was developed by the departments of Medical Psychology, Psychotherapy and Psychosomatic Medicine at the University of Ulm. The commitment and creativity of the participating students in their two undergraduate years inspired us to offer them an interest-guided curriculum for their six clinical semesters. Our paper reports the extensive results of two evaluations that we conducted during the clinical part of this new teaching-model. It became evident that we were successful in transferring continuous, intense and patient-centred psychosomatic and psychosocial contents. Yet the transfer of basic and methodological knowledge was not realised to the extent the students would have appreciated. The positive results of our project encouraged us to expand the concept of an interest-guided curriculum onto the whole academic education in psychotherapy and psychosomatic medicine at our university.

ACR Appropriateness Criteria® Chronic Ankle Pain.

PubMed

Chang, Eric Y; Tadros, Anthony S; Amini, Behrang; Bell, Angela M; Bernard, Stephanie A; Fox, Michael G; Gorbachova, Tetyana; Ha, Alice S; Lee, Kenneth S; Metter, Darlene F; Mooar, Pekka A; Shah, Nehal A; Singer, Adam D; Smith, Stacy E; Taljanovic, Mihra S; Thiele, Ralf; Kransdorf, Mark J

2018-05-01

Chronic ankle pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic ankle pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2018 American College of Radiology. Published by Elsevier Inc. All rights reserved.

ACR Appropriateness Criteria® Chronic Hip Pain.

PubMed

Mintz, Douglas N; Roberts, Catherine C; Bencardino, Jenny T; Baccei, Steven J; Caird, Michelle S; Cassidy, R Carter; Chang, Eric Y; Fox, Michael G; Gyftopoulos, Soterios; Kransdorf, Mark J; Metter, Darlene F; Morrison, William B; Rosenberg, Zehava S; Shah, Nehal A; Small, Kirstin M; Subhas, Naveen; Tambar, Siddharth; Towers, Jeffrey D; Yu, Joseph S; Weissman, Barbara N

2017-05-01

Chronic hip pain is a common clinical problem whose cause is often elucidated by imaging. The ACR Appropriateness Criteria for chronic hip pain define best practices of image ordering. Clinical scenarios are followed by the imaging choices and their appropriateness. The information is in ordered tables with an accompanying narrative explanation to guide physicians to order the right test. The American College of Radiology Appropriateness Criteria are evidence-based guidelines for specific clinical conditions that are reviewed annually by a multidisciplinary expert panel. The guideline development and revision include an extensive analysis of current medical literature from peer-reviewed journals and the application of well-established methodologies (RAND/UCLA Appropriateness Method and Grading of Recommendations Assessment, Development, and Evaluation or GRADE) to rate the appropriateness of imaging and treatment procedures for specific clinical scenarios. In those instances where evidence is lacking or equivocal, expert opinion may supplement the available evidence to recommend imaging or treatment. Copyright © 2017 American College of Radiology. Published by Elsevier Inc. All rights reserved.

Localized scleroderma en coup de sabre in the Neurology Clinic.

PubMed

Pinho, João; Rocha, João; Sousa, Filipa; Macedo, Cristiana; Soares-Fernandes, João; Cerqueira, João; Maré, Ricardo; Lourenço, Esmeralda; Pereira, João

2016-07-01

Localized scleroderma en coup de sabre (LScs) is a form of localized scleroderma thought to be an autoimmune disorder. Central nervous system involvement is not rare and neurological manifestations include seizures, focal neurological deficits, headache and neuropsychiatric changes. Patients attending the Neurology Clinic with the final diagnosis of LScs with neurological manifestations were identified and clinical and imagiological records reviewed. Five patients (0.024%) had LScs with neurological involvement, presenting with transient focal neurologic deficits, seizures, headache or migraine with aura. Neuroimaging studies confirmed localized skin depression and showed bone thinning, white matter lesions, brain calcifications, sulcal effacement and meningeal enhancement. Three patients experienced clinical improvement after immunosuppressive therapy, and in two of these patients neuroimaging findings also improved. Recognizing typical dermatologic changes is keystone for the diagnosis of LScs with neurological involvement. It is a diagnosis of exclusion and extensive etiological diagnostic evaluation should be performed. Treatment options, including conservative follow-up or immunosuppressive therapy, should be carefully considered. Copyright © 2016 Elsevier B.V. All rights reserved.

Comparison of different skin preservation methods with gamma irradiation.

PubMed

Guerrero, Linda; Camacho, Bernardo

2017-06-01

Allografts are in constant demand, not only for burn victims, but also for all open wounds as "biological dressings". Tissue quality and security are two of the major concerns of Tissue Banks. There are limited studies published. There has been extensive discussion on the subject of preservation methods for cadaver skin. Most literature available comes from clinical reports. In this research, the authors compared 85% glycerolized non irradiated skin allografts with three glycerolized irradiated skin allografts (using different glycerol concentrations 50%, 70% and 85%). The evaluation of allograft quality was done by measuring physical and biological properties of such prepared human tissue grafts. In the histological structure evaluation changes were minimal and did not alter the skin structure. The clinical function of their behavior as temporal dressings was tested. They proved to have similar capabilities for improving granulating tissue and contributing to wound beds closure (Hickerson et al. (1994) [1]). Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Discovery and evaluation of a series of 3-acylindole imidazopyridine platelet-activating factor antagonists.

PubMed

Curtin, M L; Davidsen, S K; Heyman, H R; Garland, R B; Sheppard, G S; Florjancic, A S; Xu, L; Carrera, G M; Steinman, D H; Trautmann, J A; Albert, D H; Magoc, T J; Tapang, P; Rhein, D A; Conway, R G; Luo, G; Denissen, J F; Marsh, K C; Morgan, D W; Summers, J B

1998-01-01

Studies conducted with the goal of discovering a second-generation platelet-activating factor (PAF) antagonist have identified a novel class of potent and orally active antagonists which have high aqueous solubility and long duration of action in animal models. The compounds arose from the combination of the lipophilic indole portion of Abbott's first-generation PAF antagonist ABT-299 (2) with the methylimidazopyridine heterocycle moiety of British Biotechnology's BB-882 (1) and possess the positive attributes of both of these clinical candidates. Structure-activity relationship (SAR) studies indicated that modification of the indole and benzoyl spacer of lead compound 7b gave analogues that were more potent, longer-lived, and bioavailable and resulted in the identification of 1-(N, N-dimethylcarbamoyl)-4-ethynyl-3-[3-fluoro-4-[(1H-2-methylimidazo[4,5-c] pyrid-1-yl)methyl]benzoyl]indole hydrochloride (ABT-491, 22 m.HCl) which has been evaluated extensively and is currently in clinical development.

Radiographic and scintigraphic evaluation of total knee arthroplasty

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

Schneider, R.; Soudry, M.

1986-04-01

Various radiographic and scintigraphic methods are used to supplement clinical findings in the evaluation of total knee arthroplasty and its complications. Serial roentgenograms offer reliable information for diagnosing mechanical loosening. Wide and extensive radiolucency at the cement-bone interface and shift in position and alignment of prosthetic components can be seen in almost all cases by the time revision is necessary. Radiographic abnormalities are usually not present in acute infection, but are often present in chronic infection. Bone scanning has a high sensitivity for diagnosis of infection or loosening, but is nonspecific because increased uptake is often present around asymptomatic totalmore » knee arthroplasties with normal radiographs. Differential bone and Gallium scanning and scanning with Indium 111-labeled leukocytes have a greater specificity for diagnosis of infection than does bone or Gallium scanning alone. Routine radiographic and scintigraphic studies have shown a high incidence of deep vein thrombosis in the calf after total knee arthroplasty. Clinically significant pulmonary embolization is infrequent.« less

Partial Edentulism and its Correlation to Age, Gender, Socio-economic Status and Incidence of Various Kennedy’s Classes– A Literature Review

PubMed Central

Krishnan, Chitra Shankar

2015-01-01

Partial edentulism, one or more teeth missing is an indication of healthy behaviour of dental practices in the society and attitude towards dental and oral care. The pattern of partial edentulism has been evaluated in many selected populations in different countries by different methods. Most of the studies have evaluated partial edentulism by surveying of Removable Partial Dentures (RPDs), patients visiting clinics, clinical records and population in particular locality. The objective of the study is to review the prevalence of partial edentulousness and its correlation to age,gender, arch predominance, socio economic factors and incidence of various Kennedy’s Classes. Key observations drawn from the review are as below. There is no gender correlation for partial edentulism.Prevalence of partial edentulism is more common in mandibular arch than maxillary arch.Younger adults have more Class III and IV RPDs. Elders have more distal extension RPDs Class I and II. PMID:26266237

Partial Edentulism and its Correlation to Age, Gender, Socio-economic Status and Incidence of Various Kennedy's Classes- A Literature Review.

PubMed

Jeyapalan, Vidhya; Krishnan, Chitra Shankar

2015-06-01

Partial edentulism, one or more teeth missing is an indication of healthy behaviour of dental practices in the society and attitude towards dental and oral care. The pattern of partial edentulism has been evaluated in many selected populations in different countries by different methods. Most of the studies have evaluated partial edentulism by surveying of Removable Partial Dentures (RPDs), patients visiting clinics, clinical records and population in particular locality. The objective of the study is to review the prevalence of partial edentulousness and its correlation to age,gender, arch predominance, socio economic factors and incidence of various Kennedy's Classes. Key observations drawn from the review are as below. There is no gender correlation for partial edentulism.Prevalence of partial edentulism is more common in mandibular arch than maxillary arch.Younger adults have more Class III and IV RPDs. Elders have more distal extension RPDs Class I and II.

Points to consider: efficacy and safety evaluations in the clinical development of ultra-orphan drugs.

PubMed

Maeda, Kojiro; Kaneko, Masayuki; Narukawa, Mamoru; Arato, Teruyo

2017-08-23

The unmet medical needs of individuals with very rare diseases are high. The clinical trial designs and evaluation methods used for 'regular' drugs are not applicable in the clinical development of ultra-orphan drugs (<1000 patients) in many cases. In order to improve the clinical development of ultra-orphan drugs, we examined several points regarding the efficient evaluations of drug efficacy and safety that could be conducted even with very small sample sizes, based on the review reports of orphan drugs approved in Japan. The clinical data packages of 43 ultra-orphan drugs approved in Japan from January 2001 to December 2014 were investigated. Japanese clinical trial data were not included in the clinical data package for eight ultra-orphan drugs, and non-Japanese clinical trial data were included for six of these eight drug. Japanese supportive data that included retrospective studies, published literature, clinical research and Japanese survey results were clinical data package attachments in 22 of the 43 ultra-orphan drugs. Multinational trials were conducted for three ultra-orphan drugs. More than two randomized controlled trials (RCTs) were conducted for only 11 of the 43 ultra-orphan drugs. The smaller the number of patients, the greater the proportion of forced titration and optional titration trials were conducted. Extension trials were carried out for enzyme preparations and monoclonal antibodies with high ratio. Post-marketing surveillance of all patients was required in 36 of the 43 ultra-orphan drugs. For ultra-orphan drugs, clinical endpoints were used as the primary efficacy endpoint of the pivotal trial only for two drugs. The control groups in RCTs were classified as follows: placebo groups different dosage groups, and active controls groups. Sample sizes have been determined on the basis of feasibility for some ultra-orphan drugs. We provide "Draft Guidance on the Clinical Development of Ultra-Orphan Drugs" based on this research. The development of ultra-orphan drugs requires various arrangements regarding evidence collection, data sources and the clinical trial design. We expect that this draft guidance is useful for ultra-orphan drugs developments in future.

Comparison of Pressure Changes by Head and Neck Position between High-Volume Low-Pressure and Taper-Shaped Cuffs: A Randomized Controlled Trial

PubMed Central

Komasawa, Nobuyasu; Mihara, Ryosuke; Imagawa, Kentaro; Hattori, Kazuo; Minami, Toshiaki

2015-01-01

The present study compared changes in cuff pressure by head and neck position between high-volume low-pressure (HVLP) and taper-shaped (taper) cuffs in a prospective randomized clinical trial. Methods. Forty patients were intubated using tracheal tubes with either HVLP (n = 20; HVLP group) or taper-shaped (n = 20; Taper group) cuffs. Initial cuff pressure was adjusted to 15, 20, or 25 cmH2O in the neutral position. Cuff pressure was evaluated after changing the head and neck positions to flexion, extension, and rotation. Results. Cuff pressure significantly increased with flexion in both HVLP and Taper groups at all initial cuff pressures. It significantly increased with extension in the HVLP group, but not in the Taper group. Cuff pressure did not significantly differ with rotation in either group and was significantly smaller in the Taper group during flexion and extension than in the HVLP group, regardless of initial cuff pressure. Conclusion. Cuff pressure changes with head and neck flexion and extension were smaller in the Taper group than in the HVLP group. Our results highlight the potential for taper cuffs to prevent excessive cuff pressure increases with positional changes in the head and neck. This trial is registered with UMIN000016119. PMID:26509152

Kinesio Taping effects on knee extension force among soccer players

PubMed Central

Serra, Maysa V. G. B.; Vieira, Edgar R.; Brunt, Denis; Goethel, Márcio F.; Gonçalves, Mauro; Quemelo, Paulo R. V.

2015-01-01

Background: Kinesio Taping (KT) is widely used, however the effects of KT on muscle activation and force are contradictory. Objective: To evaluate the effects of KT on knee extension force in soccer players. Method: This is a clinical trial study design. Thirty-four subjects performed two maximal isometric voluntary contractions of the lower limbs pre, immediately post, and 24 hours after tape application on the lower limbs. Both lower limbs were taped, using K-Tape and 3M Micropore tape randomly on the right and left thighs of the participants. Isometric knee extension force was measured for dominant side using a strain gauge. The following variables were assessed: peak force, time to peak force, rate of force development until peak force, time to peak rate of force development, and 200 ms pulse. Results: There were no statistically significant differences in the variables assessed between KT and Micropore conditions (F=0.645, p=0.666) or among testing sessions (pre, post, and 24h after) (F=0.528, p=0.868), and there was no statistical significance (F=0.271, p=0.986) for interaction between tape conditions and testing session. Conclusion: KT did not affect the force-related measures assessed immediately and 24 hours after the KT application compared with Micropore application, during maximal isometric voluntary knee extension. PMID:25789557

Kinesio Taping effects on knee extension force among soccer players.

PubMed

Serra, Maysa V G B; Vieira, Edgar R; Brunt, Denis; Goethel, Márcio F; Gonçalves, Mauro; Quemelo, Paulo R V

2015-01-01

Kinesio Taping (KT) is widely used, however the effects of KT on muscle activation and force are contradictory. To evaluate the effects of KT on knee extension force in soccer players. This is a clinical trial study design. Thirty-four subjects performed two maximal isometric voluntary contractions of the lower limbs pre, immediately post, and 24 hours after tape application on the lower limbs. Both lower limbs were taped, using K-Tape and 3M Micropore tape randomly on the right and left thighs of the participants. Isometric knee extension force was measured for dominant side using a strain gauge. The following variables were assessed: peak force, time to peak force, rate of force development until peak force, time to peak rate of force development, and 200 ms pulse. There were no statistically significant differences in the variables assessed between KT and Micropore conditions (F=0.645, p=0.666) or among testing sessions (pre, post, and 24h after) (F=0.528, p=0.868), and there was no statistical significance (F=0.271, p=0.986) for interaction between tape conditions and testing session. KT did not affect the force-related measures assessed immediately and 24 hours after the KT application compared with Micropore application, during maximal isometric voluntary knee extension.

Use of 16S rRNA gene for identification of a broad range of clinically relevant bacterial pathogens

DOE PAGES

Srinivasan, Ramya; Karaoz, Ulas; Volegova, Marina; ...

2015-02-06

According to World Health Organization statistics of 2011, infectious diseases remain in the top five causes of mortality worldwide. However, despite sophisticated research tools for microbial detection, rapid and accurate molecular diagnostics for identification of infection in humans have not been extensively adopted. Time-consuming culture-based methods remain to the forefront of clinical microbial detection. The 16S rRNA gene, a molecular marker for identification of bacterial species, is ubiquitous to members of this domain and, thanks to ever-expanding databases of sequence information, a useful tool for bacterial identification. In this study, we assembled an extensive repository of clinical isolates (n =more » 617), representing 30 medically important pathogenic species and originally identified using traditional culture-based or non-16S molecular methods. This strain repository was used to systematically evaluate the ability of 16S rRNA for species level identification. To enable the most accurate species level classification based on the paucity of sequence data accumulated in public databases, we built a Naïve Bayes classifier representing a diverse set of high-quality sequences from medically important bacterial organisms. We show that for species identification, a model-based approach is superior to an alignment based method. Overall, between 16S gene based and clinical identities, our study shows a genus-level concordance rate of 96% and a species-level concordance rate of 87.5%. We point to multiple cases of probable clinical misidentification with traditional culture based identification across a wide range of gram-negative rods and gram-positive cocci as well as common gram-negative cocci.« less

Use of 16S rRNA Gene for Identification of a Broad Range of Clinically Relevant Bacterial Pathogens

PubMed Central

Srinivasan, Ramya; Karaoz, Ulas; Volegova, Marina; MacKichan, Joanna; Kato-Maeda, Midori; Miller, Steve; Nadarajan, Rohan; Brodie, Eoin L.; Lynch, Susan V.

2015-01-01

According to World Health Organization statistics of 2011, infectious diseases remain in the top five causes of mortality worldwide. However, despite sophisticated research tools for microbial detection, rapid and accurate molecular diagnostics for identification of infection in humans have not been extensively adopted. Time-consuming culture-based methods remain to the forefront of clinical microbial detection. The 16S rRNA gene, a molecular marker for identification of bacterial species, is ubiquitous to members of this domain and, thanks to ever-expanding databases of sequence information, a useful tool for bacterial identification. In this study, we assembled an extensive repository of clinical isolates (n = 617), representing 30 medically important pathogenic species and originally identified using traditional culture-based or non-16S molecular methods. This strain repository was used to systematically evaluate the ability of 16S rRNA for species level identification. To enable the most accurate species level classification based on the paucity of sequence data accumulated in public databases, we built a Naïve Bayes classifier representing a diverse set of high-quality sequences from medically important bacterial organisms. We show that for species identification, a model-based approach is superior to an alignment based method. Overall, between 16S gene based and clinical identities, our study shows a genus-level concordance rate of 96% and a species-level concordance rate of 87.5%. We point to multiple cases of probable clinical misidentification with traditional culture based identification across a wide range of gram-negative rods and gram-positive cocci as well as common gram-negative cocci. PMID:25658760

The Effectiveness of PNF Versus Static Stretching on Increasing Hip-Flexion Range of Motion.

PubMed

Lempke, Landon; Wilkinson, Rebecca; Murray, Caitlin; Stanek, Justin

2018-05-22

Clinical Scenario: Stretching is applied for the purposes of injury prevention, increasing joint range of motion (ROM), and increasing muscle extensibility. Many researchers have investigated various methods and techniques to determine the most effective way to increase joint ROM and muscle extensibility. Despite the numerous studies conducted, controversy still remains within clinical practice and the literature regarding the best methods and techniques for stretching. Focused Clinical Question: Is proprioceptive neuromuscular facilitation (PNF) stretching more effective than static stretching for increasing hamstring muscle extensibility through increased hip ROM or increased knee extension angle (KEA) in a physically active population? Summary of Key Findings: Five studies met the inclusion criteria and were included. All 5 studies were randomized control trials examining mobility of the hamstring group. The studies measured hamstring ROM in a variety of ways. Three studies measured active KEA, 1 study measured passive KEA, and 1 study measured hip ROM via the single-leg raise test. Of the 5 studies, 1 study found greater improvements using PNF over static stretching for increasing hip flexion, and the remaining 4 studies found no significant difference between PNF stretching and static stretching in increasing muscle extensibility, active KEA, or hip ROM. Clinical Bottom Line: PNF stretching was not demonstrated to be more effective at increasing hamstring extensibility compared to static stretching. The literature reviewed suggests both are effective methods for increasing hip-flexion ROM. Strength of Recommendation: Using level 2 evidence and higher, the results show both static and PNF stretching effectively increase ROM; however, one does not appear to be more effective than the other.

Performance evaluation of extension education centers in universities based on the balanced scorecard.

PubMed

Wu, Hung-Yi; Lin, Yi-Kuei; Chang, Chi-Hsiang

2011-02-01

This study aims at developing a set of appropriate performance evaluation indices mainly based on balanced scorecard (BSC) for extension education centers in universities by utilizing multiple criteria decision making (MCDM). Through literature reviews and experts who have real practical experiences in extension education, adequate performance evaluation indices have been selected and then utilizing the decision making trial and evaluation laboratory (DEMATEL) and analytic network process (ANP), respectively, further establishes the causality between the four BSC perspectives as well as the relative weights between evaluation indices. According to this previous result, an empirical analysis of the performance evaluation of extension education centers of three universities at Taoyuan County in Taiwan is illustrated by applying VlseKriterijumska Optimizacija I Kompromisno Resenje (VIKOR). From the analysis results, it indicates that "Learning and growth" is the significant influential factor and it would affect the other three perspectives. In addition, it is discovered that "Internal process" perspective as well as "Financial" perspective play important roles in the performance evaluation of extension education centers. The top three key performance indices are "After-sales service", "Turnover volume", and "Net income". The proposed evaluation model could be considered as a reference for extension education centers in universities to prioritize their improvements on the key performance indices after performing VIKOR analyses. 2010 Elsevier Ltd. All rights reserved.

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.

Audit of the autoantibody test, EarlyCDT®-lung, in 1600 patients: an evaluation of its performance in routine clinical practice.

PubMed

Jett, James R; Peek, Laura J; Fredericks, Lynn; Jewell, William; Pingleton, William W; Robertson, John F R

2014-01-01

EarlyCDT(®)-Lung may enhance detection of early stage lung cancer by aiding physicians in assessing high-risk patients through measurement of biological markers (i.e., autoantibodies). The test's performance characteristics in routine clinical practice were evaluated by auditing clinical outcomes of 1613 US patients deemed at high risk for lung cancer by their physician, who ordered the EarlyCDT-Lung test for their patient. Clinical outcomes for all 1613 patients who provided HIPAA authorization are reported. Clinical data were collected from each patient's treating physician. Pathology reports when available were reviewed for diagnostic classification. Staging was assessed on histology, otherwise on imaging. Six month follow-up for the positives/negatives was 99%/93%. Sixty-one patients (4%) were identified with lung cancer, 25 of whom tested positive by EarlyCDT-Lung (sensitivity=41%). A positive EarlyCDT-Lung test on the current panel was associated with a 5.4-fold increase in lung cancer incidence versus a negative. Importantly, 57% (8/14) of non-small cell lung cancers detected as positive (where stage was known) were stage I or II. EarlyCDT-Lung has been extensively tested and validated in case-control settings and has now been shown in this audit to perform in routine clinical practice as predicted. EarlyCDT-Lung may be a complementary tool to CT for detection of early lung cancer. Copyright © 2013 The Authors. Published by Elsevier Ireland Ltd.. All rights reserved.

Extensive Mobile Thrombus of the Internal Carotid Discovered After Intravenous Thrombolysis

PubMed Central

Fugate, Jennifer E.; Hocker, Sara E.

2016-01-01

This case report describes a rare presentation of ischemic stroke secondary to an extensive internal carotid artery thrombus, subsequent therapeutic dilemma, and clinical management. A 58-year-old man was administered intravenous (IV) thrombolysis for right middle cerebral artery territory ischemic stroke symptoms. A computed tomography angiogram of the head and neck following thrombolysis showed a longitudinally extensive internal carotid artery thrombus originating at the region of high-grade calcific stenosis. Mechanical embolectomy was deferred because of risk of clot dislodgement and mild neurological symptoms. Recumbency and hemodynamic augmentation were used acutely to support cerebral perfusion. Anticoagulation was started 24 hours after thrombolysis. Carotid endarterectomy was completed successfully within 1 week of presentation. Clinical outcome was satisfactory with discharge modified Rankin Scale score 0. A longitudinally extensive carotid artery thrombus poses a risk of dislodgement and hemispheric stroke. Optimal management in these cases is not known with certainty. In our case, IV thrombolysis, hemodynamic augmentation, delayed anticoagulation, and carotid endarterectomy resulted in a favorable clinical outcome. PMID:28400904

Prevention of distal extension cantilever fracture in mandibular overdentures.

PubMed

Quirynen, Thomas; Quirynen, Marc; Duyck, Joke

2015-09-01

Fractures of distal bar extensions, supporting a mandibular overdenture, do occur with significant functional and economic consequences for the patient. This study therefore aims to evaluate the effect of different bar cross-sectional shapes and surfaces, bar extension lengths and the placement of a support rib under the distal bar extension on fracture resistance. The 2nd moment area and static strength were calculated for 11 frequently used bar designs using finite element analysis (FEA). For two specific designs (Ackermann round Ø 1.8mm and Dolder-Y macro, the former with and without a support rib) additional physical static and fatigue strength tests were included. The FEA static strength data corresponded well to the 2nd moment area (a similar ranking when maximum allowed force was considered). The application of a rib support (Ackermann Ø 1.8mm) and limitations of the bar extension length (6mm for the Ackermann Ø 1.8mm, 8mm for the Dolder-Y macro) allowed the bars to exceed 5 × 10(6) cycles of 120 and 250N, respectively, before fracture. The region of highest stresses in FEA corresponded well with the locations of the fractures observed in static- and fatigue-testing. With some simple guidelines/modifications, the number of bar extension fractures can be reduced significantly. This study focusses on distal bar extensions which improve the positioning of an implant supported overdenture. By combining laboratory testing and finite element simulations we aim to: (1) explain why fractures occur (dependent on physical characteristics of the bar), and (2) give clinical guidelines on how to prevent such fractures. Copyright © 2015 Elsevier Ltd. All rights reserved.

Extension of the Thoracic Spine Sign: A New Sonographic Marker of Pleural Effusion.

PubMed

Dickman, Eitan; Terentiev, Victoria; Likourezos, Antonios; Derman, Anna; Haines, Lawrence

2015-09-01

Dyspnea is a common emergency department (ED) condition, which may be caused by pleural effusion and other thoracic diseases. We present data on a new sonographic marker, the extension of the thoracic spine sign, for diagnosis of pleural effusion. In this prospective study, we enrolled a convenience sample of undifferentiated patients who underwent computed tomography (CT) of the abdomen or chest, which was performed as part of their emergency department evaluations. Patients underwent chest sonography to assess the utility of the extension of the thoracic spine sign for diagnosing pleural effusion. The point-of-care sonographic examinations were performed and interpreted by emergency physicians who were blinded to information in the medical records. Sonographic results were compared to radiologists' interpretations of the CT results, which were considered the criterion standard. Forty-one patients were enrolled, accounting for 82 hemithoraces. Seven hemithoraces were excluded from the analysis due to various limitations, leaving 75 hemithoraces for the final analysis. The median time for completion of the sonographic examination was 3 minutes. The sensitivity and specificity for extension of the thoracic spine were 73.7% (95% confidence interval [CI], 48.6%-89.9%) and 92.9% (95%CI, 81.9%-97.7%), respectively. Overall, there were 5 hemithoraces with false-negative results when using the extension sign. Of those 5 cases, 4 were found to have trace pleural effusions on CT. When trace pleural effusions were excluded in a subgroup analysis, the sensitivity and specificity of extension of the thoracic spine were 92.9% (95% CI, 64.2%-99.6%) and 92.9% (95% CI, 81.9%-97.7%). We found the extension of the thoracic spine sign to be an excellent diagnostic tool for clinically relevant pleural effusion. © 2015 by the American Institute of Ultrasound in Medicine.

Implementation of workflow engine technology to deliver basic clinical decision support functionality

PubMed Central

2011-01-01

Background Workflow engine technology represents a new class of software with the ability to graphically model step-based knowledge. We present application of this novel technology to the domain of clinical decision support. Successful implementation of decision support within an electronic health record (EHR) remains an unsolved research challenge. Previous research efforts were mostly based on healthcare-specific representation standards and execution engines and did not reach wide adoption. We focus on two challenges in decision support systems: the ability to test decision logic on retrospective data prior prospective deployment and the challenge of user-friendly representation of clinical logic. Results We present our implementation of a workflow engine technology that addresses the two above-described challenges in delivering clinical decision support. Our system is based on a cross-industry standard of XML (extensible markup language) process definition language (XPDL). The core components of the system are a workflow editor for modeling clinical scenarios and a workflow engine for execution of those scenarios. We demonstrate, with an open-source and publicly available workflow suite, that clinical decision support logic can be executed on retrospective data. The same flowchart-based representation can also function in a prospective mode where the system can be integrated with an EHR system and respond to real-time clinical events. We limit the scope of our implementation to decision support content generation (which can be EHR system vendor independent). We do not focus on supporting complex decision support content delivery mechanisms due to lack of standardization of EHR systems in this area. We present results of our evaluation of the flowchart-based graphical notation as well as architectural evaluation of our implementation using an established evaluation framework for clinical decision support architecture. Conclusions We describe an implementation of a free workflow technology software suite (available at http://code.google.com/p/healthflow) and its application in the domain of clinical decision support. Our implementation seamlessly supports clinical logic testing on retrospective data and offers a user-friendly knowledge representation paradigm. With the presented software implementation, we demonstrate that workflow engine technology can provide a decision support platform which evaluates well against an established clinical decision support architecture evaluation framework. Due to cross-industry usage of workflow engine technology, we can expect significant future functionality enhancements that will further improve the technology's capacity to serve as a clinical decision support platform. PMID:21477364

Warfarin-induced eosinophilic pleurisy.

PubMed

Kuwahara, T; Hamada, M; Inoue, Y; Aono, S; Hiwada, K

1995-08-01

A 51-year-old man was admitted to our hospital because of dry cough and low grade fever with right-sided pleural fluid and blood eosinophilia. Warfarin had been prescribed following coronary artery bypass grafting. After the discontinuation of warfarin the clinical and chest X-ray findings improved; readministration of the drug caused recurrent blood eosinophilia and pleural effusion in the other lung. Since no other specific etiologies for eosinophilia and pleural effusion were determined by extensive evaluation, warfarin seemed to be associated with his illness. This is the first report of warfarin-induced eosinophilic pleurisy.

Alternatives to relational database: comparison of NoSQL and XML approaches for clinical data storage.

PubMed

Lee, Ken Ka-Yin; Tang, Wai-Choi; Choi, Kup-Sze

2013-04-01

Clinical data are dynamic in nature, often arranged hierarchically and stored as free text and numbers. Effective management of clinical data and the transformation of the data into structured format for data analysis are therefore challenging issues in electronic health records development. Despite the popularity of relational databases, the scalability of the NoSQL database model and the document-centric data structure of XML databases appear to be promising features for effective clinical data management. In this paper, three database approaches--NoSQL, XML-enabled and native XML--are investigated to evaluate their suitability for structured clinical data. The database query performance is reported, together with our experience in the databases development. The results show that NoSQL database is the best choice for query speed, whereas XML databases are advantageous in terms of scalability, flexibility and extensibility, which are essential to cope with the characteristics of clinical data. While NoSQL and XML technologies are relatively new compared to the conventional relational database, both of them demonstrate potential to become a key database technology for clinical data management as the technology further advances. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Effects of static stretching of knee musculature on patellar alignment and knee functional disability in male patients diagnosed with knee extension syndrome: A single-group, pretest-posttest trial.

PubMed

Pourahmadi, Mohammad Reza; Ebrahimi Takamjani, Ismail; Hesampour, Kazem; Shah-Hosseini, Gholam Reza; Jamshidi, Ali Ashraf; Shamsi, Mohammad Bagher

2016-04-01

Knee extension (Kext) syndrome is based on movement system impairments and is described as knee pain associated with quadriceps stiffness. To investigate the effects of 3 times per week for 4 weeks static stretching of knee musculature on patellar alignment and knee functional disability in male Kext syndrome patients. A single-group, pretest-posttest clinical trial. Hazrat-e-Rasoul Akram Hospital. Forty-six male Kext syndrome patients aged 18-35 years. Knee functional disability was assessed by the Kujala questionnaire. Patellar tilt was assessed using the skyline view X-ray. In addition, patella alta was assessed by X-ray using the Insall-Salvati ratio. After intervention, changes in knee flexion-extension range of motion (ROM) and hip adduction were assessed by goniometer and inclinometer. Changes in patellar tilt and patella alta were evaluated. Correlations between muscles length, patellar tilt and knee functional disability were also evaluated. The mean of patellar tilt in male Kext syndrome patients was 15.19°. Only the correlation between rectus femoris shortness and patellar tilt (P = 0.002) and the correlation between rectus femoris shortness and knee functional disability (P = 0.037) were significant. Patella alta was not severe in male Kext syndrome patients (1.28 ± 0.10). Knee flexion-extension ROM and femoral adduction increased significantly after a 12-session stretching programme (P < 0.0001). The results demonstrated that rectus femoris shortness had higher correlation with patellar tilt and knee functional disability than iliotibial band and hamstring shortness. Stretching was effective in reducing patellar tilt, patella alta, knee functional disability, increasing knee ROM and hip adduction in these patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

Civamide cream 0.075% in patients with osteoarthritis of the knee: a 12-week randomized controlled clinical trial with a longterm extension.

PubMed

Schnitzer, Thomas J; Pelletier, Jean-Pierre; Haselwood, Doug M; Ellison, William T; Ervin, John E; Gordon, Richard D; Lisse, Jeffrey R; Archambault, W Tad; Sampson, Allan R; Fezatte, Heidi B; Phillips, Scott B; Bernstein, Joel E

2012-03-01

To evaluate the safety and efficacy of civamide cream 0.075% for the treatment of osteoarthritis (OA) of the knee. We conducted a 12-week, multicenter, randomized, double-blind study with a 52-week open-label extension. Patients with OA of the knee received either civamide cream 0.075% or a lower dose of civamide cream, 0.01%, as the control. The 3 co-primary endpoints in the double-blind study were the time-weighted average (TWA) of change from baseline to Day 84 in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, the WOMAC physical function subscale, and the Subject Global Evaluation (SGE). In the 52-week open-label extension study, the Osteoarthritis Pain Score and SGE were assessed. A total of 695 patients were randomized to receive civamide cream 0.075% (n = 351) or civamide cream 0.01% (control; n = 344) in the double-blind study. Significance in favor of civamide cream 0.075% was achieved for the TWA for all 3 co-primary efficacy variables: WOMAC pain (p = 0.009), WOMAC physical function (p < 0.001), and SGE (p = 0.008); and at Day 84 for these 3 variables (p = 0.013, p < 0.001, and p = 0.049, respectively). These analyses accounted for significant baseline-by-treatment interactions. In the 52-week open-label extension, efficacy was maintained. Civamide cream 0.075% was well tolerated throughout the studies. These studies demonstrate the efficacy of civamide cream for up to 1 year of continuous use. Civamide cream, with its lack of systemic absorption, does not have the potential for serious systemic toxicity, in contrast to several other OA treatments.

Temporal abstraction and temporal Bayesian networks in clinical domains: a survey.

PubMed

Orphanou, Kalia; Stassopoulou, Athena; Keravnou, Elpida

2014-03-01

Temporal abstraction (TA) of clinical data aims to abstract and interpret clinical data into meaningful higher-level interval concepts. Abstracted concepts are used for diagnostic, prediction and therapy planning purposes. On the other hand, temporal Bayesian networks (TBNs) are temporal extensions of the known probabilistic graphical models, Bayesian networks. TBNs can represent temporal relationships between events and their state changes, or the evolution of a process, through time. This paper offers a survey on techniques/methods from these two areas that were used independently in many clinical domains (e.g. diabetes, hepatitis, cancer) for various clinical tasks (e.g. diagnosis, prognosis). A main objective of this survey, in addition to presenting the key aspects of TA and TBNs, is to point out important benefits from a potential integration of TA and TBNs in medical domains and tasks. The motivation for integrating these two areas is their complementary function: TA provides clinicians with high level views of data while TBNs serve as a knowledge representation and reasoning tool under uncertainty, which is inherent in all clinical tasks. Key publications from these two areas of relevance to clinical systems, mainly circumscribed to the latest two decades, are reviewed and classified. TA techniques are compared on the basis of: (a) knowledge acquisition and representation for deriving TA concepts and (b) methodology for deriving basic and complex temporal abstractions. TBNs are compared on the basis of: (a) representation of time, (b) knowledge representation and acquisition, (c) inference methods and the computational demands of the network, and (d) their applications in medicine. The survey performs an extensive comparative analysis to illustrate the separate merits and limitations of various TA and TBN techniques used in clinical systems with the purpose of anticipating potential gains through an integration of the two techniques, thus leading to a unified methodology for clinical systems. The surveyed contributions are evaluated using frameworks of respective key features. In addition, for the evaluation of TBN methods, a unifying clinical domain (diabetes) is used. The main conclusion transpiring from this review is that techniques/methods from these two areas, that so far are being largely used independently of each other in clinical domains, could be effectively integrated in the context of medical decision-support systems. The anticipated key benefits of the perceived integration are: (a) during problem solving, the reasoning can be directed at different levels of temporal and/or conceptual abstractions since the nodes of the TBNs can be complex entities, temporally and structurally and (b) during model building, knowledge generated in the form of basic and/or complex abstractions, can be deployed in a TBN. Copyright © 2014 Elsevier B.V. All rights reserved.

Do the cerebellar tonsils move during flexion and extension of the neck in patients with Chiari I malformation? A radiological study with clinical implications.

PubMed

Tubbs, R Shane; Kirkpatrick, Christina M; Rizk, Elias; Chern, Joshua J; Oskouian, Rod J; Oakes, W Jerry

2016-03-01

In the past, diagnosis of the Chiari I malformation has primarily been made on midsagittal MRI. We hypothesized that based on the frequent presentation of opisthotonos in patients with hindbrain hernia (primarily Chiari II malformation but sometimes Chiari I malformation) that the hyperextension might be a compensatory technique used by such patients to bring the cerebellar tonsils up out of the cervical spine. This prospective study reviewed imaging of patients with Chiari I malformation who underwent flexion/extension MRI for evaluation of their hindbrain herniation. Age-matched controls were used for comparison. In general, there was elevation of the cerebellar tonsils with extension and increased descent with flexion of the cervical spine. In 72 % of patients, flexion of the neck resulted in descent of the cerebellar tonsils. In 64 % of patients, extension of the neck resulted in ascent of the cerebellar tonsils. In the 14 patients with an associated syrinx, 71 % were found to have caudal movement of the cerebellar tonsils with neck flexion, and only 43 % were observed to have any movement of the cerebellar tonsils in neck extension compared to patients without a syrinx where ascent of the tonsils was seen in only nine during neck extension. Two patients were observed to have the reverse finding of ascent of the cerebellar tonsils with neck flexion and descent of the cerebellar tonsils with neck extension. Five patients had no movement of the cerebellar tonsils in either flexion or extension of the neck, and one of these had a small syrinx. Although minimal and not in all patients, we observed elevation of the herniated cerebellar tonsils with extension of the cervical spine in patients with Chiari I malformation. This finding provides evidence as to why some patients with hindbrain herniation present with opisthotonos and supports earlier findings that CSF flow is reduced at the craniocervical junction in flexion in patients with Chiari I malformation.

Effects of flow rate on the migration of different plasticizers from PVC infusion medical devices

PubMed Central

Eljezi, Teuta; Clauson, Hélène; Lambert, Céline; Bouattour, Yassine; Chennell, Philip; Pereira, Bruno; Sautou, Valérie

2018-01-01

Infusion medical devices (MDs) used in hospitals are often made of plasticized polyvinylchloride (PVC). These plasticizers may leach out into infused solutions during clinical practice, especially during risk-situations, e.g multiple infusions in Intensive Care Units and thus may enter into contact with the patients. The migrability of the plasticizers is dependent of several clinical parameters such as temperature, contact time, nature of the simulant, etc… However, no data is available about the influence of the flow rate at which drug solutions are administrated. In this study, we evaluated the impact of different flow rates on the release of the different plasticizers during an infusion procedure in order to assess if they could expose the patients to more toxic amounts of plasticizers. Migration assays with different PVC infusion sets and extension lines were performed with different flow rates that are used in clinical practice during 1h, 2h, 4h, 8h and 24h, using a lipophilic drug simulant. From a clinical point of view, the results showed that, regardless of the plasticizer, the faster the flow rate, the higher the infused volume and the higher the quantities of plasticizers released, both from infusion sets and extension lines, leading to higher patient exposure. However, physically, there was no significant difference of the migration kinetics linked to the flow rate for a same medical device, reflecting complex interactions between the PVC matrix and the simulant. The migration was especially dependent on the nature and the composition of the medical device. PMID:29474357

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.

CT of Anatomic Variants of the Paranasal Sinuses and Nasal Cavity: Poor Correlation With Radiologically Significant Rhinosinusitis but Importance in Surgical Planning.

PubMed

Shpilberg, Katya A; Daniel, Simon C; Doshi, Amish H; Lawson, William; Som, Peter M

2015-06-01

The purpose of this study was to determine the incidence of sinonasal anatomic variants and to assess their relation to sinonasal mucosal disease. A retrospective evaluation of 192 sinus CT examinations of patients with a clinical history of rhinosinusitis was conducted. The CT scans were evaluated for the presence of several anatomic variants of the sinonasal cavities, and the prevalence of each variant was calculated. Prevalences of all sinonasal anatomic variants were compared between patients who had minimal to no apparent imaging evidence of rhinosinusitis and those who had radiologic evidence of clinically significant rhinosinusitis. The most common normal variants were nasal septal deviation, Agger nasi cells, and extension of the sphenoid sinuses into the posterior nasal septum. We found no statistically significant difference in the prevalence of any of the studied anatomic variants between patients with minimal and those with clinically significant paranasal sinus or nasal cavity disease. Analysis of every routine CT scan of the paranasal sinuses obtained for sinusitis or rhinitis for the presence of different anatomic variants is of questionable value unless surgery is planned.

SITC/iSBTc Cancer Immunotherapy Biomarkers Resource Document: Online resources and useful tools - a compass in the land of biomarker discovery

PubMed Central

2011-01-01

Recent positive clinical results in cancer immunotherapy point to the potential of immune-based strategies to provide effective treatment of a variety of cancers. In some patients, the responses to cancer immunotherapy are durable, dramatically extending survival. Extensive research efforts are being made to identify and validate biomarkers that can help identify subsets of cancer patients that will benefit most from these novel immunotherapies. In addition to the clear advantage of such predictive biomarkers, immune biomarkers are playing an important role in the development, clinical evaluation and monitoring of cancer immunotherapies. This Cancer Immunotherapy Resource Document, prepared by the Society for Immunotherapy of Cancer (SITC, formerly the International Society for Biological Therapy of Cancer, iSBTc), provides key references and online resources relevant to the discovery, evaluation and clinical application of immune biomarkers. These key resources were identified by experts in the field who are actively pursuing research in biomarker identification and validation. This organized collection of the most useful references, online resources and tools serves as a compass to guide discovery of biomarkers essential to advancing novel cancer immunotherapies. PMID:21929757

MRI to assess renal structure and function.

PubMed

Artunc, Ferruh; Rossi, Cristina; Boss, Andreas

2011-11-01

In addition to excellent anatomical depiction, MRI techniques have expanded to study functional aspects of renal physiology, such as renal perfusion, glomerular filtration rate (GFR) or tissue oxygenation. This review will focus on current developments with an emphasis on clinical applicability. The method of GFR determination is largely heterogeneous and still has weaknesses. However, the technique of employing liver disappearance curves has been shown to be accurate in healthy persons and patients with chronic kidney disease. In potential kidney donors, complete evaluation of kidney anatomy and function can be accomplished in a single-stop investigation. Techniques without contrast media can be utilized to measure renal tissue oxygenation (blood oxygen level-dependent MRI) or perfusion (arterial spin labeling) and could aid in the diagnosis and treatment of ischemic renal diseases, such as renal artery stenosis. Diffusion imaging techniques may provide information on spatially restricted water diffusion and tumor cellularity. Functional MRI opens new horizons in studying renal physiology and pathophysiology in vivo. Although extensively utilized in research, labor-intensive postprocessing and lack of standardization currently limit the clinical applicability of functional MRI. Further studies are necessary to evaluate the clinical value of functional magnetic resonance techniques for early discovery and characterization of kidney disease.

Phosphatidylserine containing omega-3 Fatty acids may improve memory abilities in nondemented elderly individuals with memory complaints: results from an open-label extension study.

PubMed

Vakhapova, Veronika; Cohen, Tzafra; Richter, Yael; Herzog, Yael; Kam, Yossi; Korczyn, Amos D

2014-01-01

The present study is an open-label extension (OLE) aimed at evaluating the effect of 100 mg/day of phosphatidylserine enriched with docosahexaenoic acid (PS-DHA) on cognitive performance in nondemented elderly individuals with memory complaints. From the participants who completed the core study, 122 continued with a 15-week OLE. Efficacy was assessed using a computerized tool and the Clinical Global Impression of Change (CGI-C) rating scale. A significant improvement in sustained attention and memory recognition was observed in the PS-DHA naïve group, while the PS-DHA continuers maintained their cognitive status. Additionally, a significant improvement in CGI-C was observed in the naïve group. The results demonstrate that consumption of 100 mg/day of PS-DHA might be associated with improving or maintaining cognitive status in elderly subjects with memory complaints.

Evaluation of robot-assisted gait training using integrated biofeedback in neurologic disorders.

PubMed

Stoller, Oliver; Waser, Marco; Stammler, Lukas; Schuster, Corina

2012-04-01

Neurological disorders lead to walking disabilities, which are often treated using robot-assisted gait training (RAGT) devices such as the driven gait-orthosis Lokomat. A novel integrated biofeedback system was developed to facilitate therapeutically desirable activities during walking. The aim of this study was to evaluate the feasibility to detect changes during RAGT by using this novel biofeedback approach in a clinical setting for patients with central neurological disorders. 84 subjects (50 men and 34 women, mean age of 58 ± 13 years) were followed over 8 RAGT sessions. Outcome measures were biofeedback values as weighted averages of torques measured in the joint drives and independent parameters such as guidance force, walking speed, patient coefficient, session duration, time between sessions and total treatment time. Joint segmented analysis showed significant trends for decreasing hip flexion activity (p ≤.003) and increasing knee extension activity (p ≤.001) during RAGT sessions with an intercorrelation of r=-.43 (p ≤.001). Further associations among independent variables were not statistically significant. This is the first study that evaluates the Lokomat integrated biofeedback system in different neurological disorders in a clinical setting. Results suggest that this novel biofeedback approach used in this study is not able to detect progress during RAGT. These findings should be taken into account when refining existing or developing new biofeedback strategies in RAGT relating to appropriate systems to evaluate progress and support therapist feedback in clinical settings. Copyright © 2011 Elsevier B.V. All rights reserved.

OntoCR: A CEN/ISO-13606 clinical repository based on ontologies.

PubMed

Lozano-Rubí, Raimundo; Muñoz Carrero, Adolfo; Serrano Balazote, Pablo; Pastor, Xavier

2016-04-01

To design a new semantically interoperable clinical repository, based on ontologies, conforming to CEN/ISO 13606 standard. The approach followed is to extend OntoCRF, a framework for the development of clinical repositories based on ontologies. The meta-model of OntoCRF has been extended by incorporating an OWL model integrating CEN/ISO 13606, ISO 21090 and SNOMED CT structure. This approach has demonstrated a complete evaluation cycle involving the creation of the meta-model in OWL format, the creation of a simple test application, and the communication of standardized extracts to another organization. Using a CEN/ISO 13606 based system, an indefinite number of archetypes can be merged (and reused) to build new applications. Our approach, based on the use of ontologies, maintains data storage independent of content specification. With this approach, relational technology can be used for storage, maintaining extensibility capabilities. The present work demonstrates that it is possible to build a native CEN/ISO 13606 repository for the storage of clinical data. We have demonstrated semantic interoperability of clinical information using CEN/ISO 13606 extracts. Copyright © 2016 Elsevier Inc. All rights reserved.

Dynamic cervical stabilization: a multicenter study.

PubMed

Matgé, Guy; Buddenberg, Peter; Eif, Marcus; Schenke, Holger; Herdmann, Joerg

2015-12-01

The dynamic cervical implant (DCI) is a novel motion-preserving concept for the treatment of degenerative cervical disorders. The aim of this prospective clinical study was to validate the concept and analyse clinical and radiological performance of the implant. One hundred seventy-five consecutive patients with degenerative cervical disorders, median age, 47 years, were treated with discectomy and DCI, and followed for 2 years. Clinical outcome was evaluated with the Neck Disability Index (NDI), the SF-12, and visual analogue scale (VAS) assessment of arm and neck pain. Range of motion (ROM) and cervical alignment were analysed using radiographic imaging. All clinical outcome measures--VAS neck and arm pain, NDI, and SF-12 mental and physical component summaries--improved significantly after surgery (each p < 0.001) and remained stable over the whole observation period. The ROM (flexion/extension) at the level treated with DCI was slightly reduced, but no significant changes could be verified at the adjacent levels. Six surgery or device-related adverse events were documented during the study. Good clinical and excellent radiological outcomes demonstrate that DCI is a safe and efficient treatment option in patients with degenerative cervical disorders.

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.

Influence of intentional femoral component flexion in navigated TKA on gap balance and sagittal anatomy.

PubMed

Roßkopf, J; Singh, P K; Wolf, P; Strauch, M; Graichen, H

2014-03-01

Navigation has proven its ability to accurately restore coronal leg axis; however, for a good clinical outcome, other factors such as sagittal anatomy and balanced gaps are at least as important. In a gap-balanced technique, the size of the flexion gap is equalled to that of the extension gap. Flexion of the femoral component has been described as a theoretical possibility to balance flexion and extension gap. Aim of this study was to assess whether intentional femoral component flexion is helpful in balancing TKA gaps and in restoring sagittal anatomy. One hundred and thirty-one patients with TKA were included in this study. Implantation was performed in a navigated, gap-balanced, tibia-first technique. The femoral component flexion needed to equal flexion to extension gap was calculated based upon the navigation data. The sagittal diameter, the anterior and posterior offset were measured pre- and postoperatively based on the lateral radiographs. Medial and lateral gaps in extension and flexion as well as flexion/extension gap differences pre- and postoperatively were analysed. Additionally range of motion (ROM) and patient satisfaction (SF 12) were obtained. To achieve equal flexion and extension gap, the femoral component was flexed in 120 out of 131 patients showing mean flexion of 2.9° (SD 2.2°; navigation data) and 3.1° (SD 2.0°; radiological analysis), respectively. Based on this technique, it was possible to balance the extension gap (<2 mm difference) in 130 out of 131 patients (99%) and the flexion gap in 119 out of 131 (91%). The difference between extension and flexion gap was reduced from 39 to 24 out of 131 patients (81%) on the medial side and from 69 to 28 on the lateral side (79%). The sagittal diameter was restored in 114 out of 131 cases (87%); however, anterior offset was significantly reduced by 1.3 mm (SD 3.9°), and posterior offset was significantly increased by 1.6 mm (SD 3.3°). No correlation between any navigation and radiological parameter was found with ROM and SF 12. The navigation-based, gap-balanced technique allows intentional flexion of the femoral component in order to balance gaps in more than 90% of primary TKA cases. Simultaneously, the sagittal diameter is restored in 87% of patients. However, to achieve equal gaps, the posterior offset is significantly increased by 1.6 mm and the femoral component is flexed by 3°. To evaluate the effect of this technique on the clinical outcome, future studies are needed. II.

Histopathologic grading of medulloblastomas: a Pediatric Oncology Group study.

PubMed

Eberhart, Charles G; Kepner, James L; Goldthwaite, Patricia T; Kun, Larry E; Duffner, Patricia K; Friedman, Henry S; Strother, Douglas R; Burger, Peter C

2002-01-15

Medulloblastomas are small cell embryonal tumors of the cerebellum found predominantly in children, only slightly more than half of whom survive. Predicting favorable outcome has been difficult, and improved stratification clearly is required to avoid both undertreatment and overtreatment. Patients currently are staged clinically, but no pathologic staging system is in use. Two rare subtypes at extreme ends of the histologic spectrum, i.e., medulloblastomas with extensive nodularity and large cell/anaplastic medulloblastomas, are associated with better and worse clinical outcomes, respectively. However, there is little data about correlations between histologic features and clinical outcome for most patients with medulloblastomas that fall between these histologic extremes of nodularity and anaplasia. Therefore, the authors evaluated the clinical effects of increasing anaplasia and nodularity in a large group of children with medulloblastomas, hypothesizing that increasing nodularity would predict better clinical outcomes and that increasing anaplasia would presage less favorable results. Medulloblastomas from 330 Pediatric Oncology Group patients were evaluated histologically with respect to extent of nodularity, presence of desmoplasia, grade of anaplasia, and extent of anaplasia. Pathologic and clinical data were then compared using Kaplan-Meier and log-rank analyses. Increasing grade of anaplasia and extent of anaplasia were associated strongly with progressively worse clinical outcomes (P < 0.0001 for both). Significant anaplasia (moderate or severe) was identified in 24% of medulloblastoma specimens. Neither increasing degrees of nodularity nor desmoplasia were associated significantly with longer survival. Moderate anaplasia and severe anaplasia were associated with aggressive clinical behavior in patients with medulloblastomas and were detected in a significant number of specimens (24%). Pathologic grading of medulloblastomas with respect to anaplasia may be of clinical utility.

Extrathyroidal Extension Is Associated with Compromised Survival in Patients with Thyroid Cancer.

PubMed

Youngwirth, Linda M; Adam, Mohamed A; Scheri, Randall P; Roman, Sanziana A; Sosa, Julie A

2017-05-01

Patients with thyroid cancer who have extrathyroidal extension (ETE) are considered to have more advanced tumors. However, data on the impact of ETE on patient outcomes remain limited. The purpose of this study was to evaluate the association between ETE and survival in patients with thyroid cancer. The National Cancer Database (1998-2012) was queried for all adult patients with differentiated thyroid cancer and medullary thyroid cancer. Patients were divided into three groups: no ETE (T1 and T2 tumors), minimal ETE (T3 tumors <4 cm), and extensive ETE (T4 tumors <4 cm). Patient demographic, clinical, and pathologic factors were evaluated for all patients. A Cox proportional hazards model was developed for each histology to identify factors associated with survival. In total, 241,118 patients with differentiated thyroid cancer met the inclusion criteria; 86.9% had no ETE, 9.1% minimal ETE, and 4.0% extensive ETE. Compared with patients with no ETE, patients with minimal and extensive ETE were more likely to have larger tumors (1.4 cm vs. 1.8 cm and 2.0 cm, respectively), lymphovascular invasion (8.6% vs. 28.0% and 35.1%, respectively), positive margins after thyroidectomy (6.1% vs. 35.2% and 45.9%, respectively), and regional lymph node metastases (32.5% vs. 67.0% and 74.6%, respectively; all p < 0.01). After adjustment, minimal ETE (hazard ratio [HR] = 1.13; p < 0.01) and extensive ETE (HR = 1.74; p < 0.01) were associated with compromised survival for patients with differentiated thyroid cancer. In total, 3415 patients with medullary thyroid cancer met the inclusion criteria; 87.9% had no ETE, 7.1% minimal ETE, and 5.0% extensive ETE. Compared with patients with no ETE, patients with minimal and extensive ETE were more likely to have larger tumors (1.7 cm vs. 2.2 cm and 2.2 cm, respectively), lymphovascular invasion (19.2% vs. 68.9% and 79.3%, respectively), positive margins after thyroidectomy (5.8% vs. 44.1% and 51.9%, respectively), and regional lymph node metastases (39.0% vs. 90.5% and 94.4%, respectively; all p < 0.01). After adjustment, extensive ETE (HR = 1.63; p = 0.01) was associated with compromised survival for patients with medullary thyroid cancer. In patients with differentiated and medullary thyroid cancers, ETE is associated with compromised survival. Given these findings, ETE should be included in the thyroid cancer treatment guidelines.

Two-Stage Categorization in Brand Extension Evaluation: Electrophysiological Time Course Evidence

PubMed Central

Wang, Xiaoyi

2014-01-01

A brand name can be considered a mental category. Similarity-based categorization theory has been used to explain how consumers judge a new product as a member of a known brand, a process called brand extension evaluation. This study was an event-related potential study conducted in two experiments. The study found a two-stage categorization process reflected by the P2 and N400 components in brand extension evaluation. In experiment 1, a prime–probe paradigm was presented in a pair consisting of a brand name and a product name in three conditions, i.e., in-category extension, similar-category extension, and out-of-category extension. Although the task was unrelated to brand extension evaluation, P2 distinguished out-of-category extensions from similar-category and in-category ones, and N400 distinguished similar-category extensions from in-category ones. In experiment 2, a prime–probe paradigm with a related task was used, in which product names included subcategory and major-category product names. The N400 elicited by subcategory products was more significantly negative than that elicited by major-category products, with no salient difference in P2. We speculated that P2 could reflect the early low-level and similarity-based processing in the first stage, whereas N400 could reflect the late analytic and category-based processing in the second stage. PMID:25438152

Proband-only medical exome sequencing as a cost-effective first-tier genetic diagnostic test for patients without prior molecular tests and clinical diagnosis in a developing country: the China experience.

PubMed

Hu, Xuyun; Li, Niu; Xu, Yufei; Li, Guoqiang; Yu, Tingting; Yao, Ru-En; Fu, Lijun; Wang, Jiwen; Yin, Lei; Yin, Yong; Wang, Ying; Jin, Xingming; Wang, Xiumin; Wang, Jian; Shen, Yiping

2017-11-02

PurposeTo evaluate the performance of proband-only medical exome sequencing (POMES) as a cost-effective first-tier diagnostic test for pediatric patients with unselected conditions.MethodsA total of 1,323 patients were tested by POMES, which targeted 2,742 known disease-causing genes. Clinical relevant variants were Sanger-confirmed in probands and parents. We assessed the diagnostic validity and clinical utility of POMES by means of a survey questionnaire.ResultsPOMES, ordered by 136 physicians, identified 512 pathogenic or likely pathogenic variants associated with over 200 conditions. The overall diagnostic rate was 28.8%, ranging from 10% in neonatal intensive care unit patients to over 35% in pediatric intensive care unit patients. The test results had an impact on the management of the 45.1% of patients for whom there were positive findings. The average turnaround time was 57 days; the cost was $360/case.ConclusionWe adopted a relatively efficient and cost-effective approach in China for the molecular diagnosis of pediatric patients with suspected genetic conditions. While training for clinical geneticists and other specialists is lagging behind in China POMES is serving as a diagnostic equalizer for patients who do not normally receive extensive clinical evaluation and clinical diagnosis prior to testing. This Chinese experience should be applicable to other developing countries that are lacking clinical, financial, and personnel resources.GENETICS in MEDICINE advance online publication, 2 November 2017; doi:10.1038/gim.2017.195.

Temporal and geographical external validation study and extension of the Mayo Clinic prediction model to predict eGFR in the younger population of Swiss ADPKD patients.

PubMed

Girardat-Rotar, Laura; Braun, Julia; Puhan, Milo A; Abraham, Alison G; Serra, Andreas L

2017-07-17

Prediction models in autosomal dominant polycystic kidney disease (ADPKD) are useful in clinical settings to identify patients with greater risk of a rapid disease progression in whom a treatment may have more benefits than harms. Mayo Clinic investigators developed a risk prediction tool for ADPKD patients using a single kidney value. Our aim was to perform an independent geographical and temporal external validation as well as evaluate the potential for improving the predictive performance by including additional information on total kidney volume. We used data from the on-going Swiss ADPKD study from 2006 to 2016. The main analysis included a sample size of 214 patients with Typical ADPKD (Class 1). We evaluated the Mayo Clinic model performance calibration and discrimination in our external sample and assessed whether predictive performance could be improved through the addition of subsequent kidney volume measurements beyond the baseline assessment. The calibration of both versions of the Mayo Clinic prediction model using continuous Height adjusted total kidney volume (HtTKV) and using risk subclasses was good, with R 2 of 78% and 70%, respectively. Accuracy was also good with 91.5% and 88.7% of the predicted within 30% of the observed, respectively. Additional information regarding kidney volume did not substantially improve the model performance. The Mayo Clinic prediction models are generalizable to other clinical settings and provide an accurate tool based on available predictors to identify patients at high risk for rapid disease progression.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

PubMed Central

Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

2013-01-01

Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

The Role of Extension Nutrition Education in Student Achievement of Nutrition Standards in Grades K-3: A Descriptive Evaluation of a School-Based Program

ERIC Educational Resources Information Center

Arnold, Mary E.; Schreiber, Debera

2012-01-01

This article reports the results of a descriptive evaluation of the impact of an in-school Extension nutrition education program in a small, very rural county. The evaluation focused on understanding the nature of the role the Extension educator plays in delivering nutrition education, the impact of the program on student learning and achievement…

Cultured autologous keratinocytes in the treatment of large and deep burns: a retrospective study over 15 years.

PubMed

Auxenfans, Celine; Menet, Veronique; Catherine, Zulma; Shipkov, Hristo; Lacroix, Pierre; Bertin-Maghit, Marc; Damour, Odile; Braye, Fabienne

2015-02-01

The aim was to review the use and indications of cultured autologous epidermis (CAE) in extensive burns and to evaluate the efficiency of our strategy of burn treatment. This retrospective study comprised 15 years (1997-2012). all patients who received CAE. patients who died before complete healing and patients who received exclusively cultured allogeneic keratinocytes. Evaluation criteria were clinical. Time and success of wound healing after CAE graft were evaluated. A total of 63 patients were included with severity Baux score of 107 (from 70 to 140) and mean percentage of TBSA of 71% (from 40% to 97%). The CAE were used as Cuono method, in STSG donor sites and deep 2nd degree burns and in combination with large-meshed STSG (1:6-1:12) in extensively burned patients. Cuono method was used in 6 patients. The final take was 16% (0-30) because of the great fragility of the obtained epidermis. Nine patients with deep 2nd degree burns (mean TBSA 81%, from 60 to 97%) were successfully treated with only CAE without skin grafting. Combined technique (STSG meshed at 1:6-1:12 covered with CAE) was used in 27 patients (mean TBSA 69%, from 49% to 96%) with 85% success rate. Finally, donor sites treated with CAE in 49 patients could be harvested several times thanks to rapid epithelialization (time of wound healing was 7 days (from 5 to 10 days)). The CAE allow rapid healing of STSG donor sites and deep 2nd second degree burns in extensively burned patients. Copyright © 2014 Elsevier Ltd and ISBI. All rights reserved.

The association between nitroglycerin use and adverse outcomes in women undergoing cesarean delivery in the second stage of labor.

PubMed

Isquick, Sarah; Henry, Dana; Nakagawa, Sanae; Moghadassi, Michelle; Thiet, Mari-Paule; Norton, Mary; Lucero, Jennifer

2017-06-01

To identify predictors of hysterotomy extension in women undergoing cesarean delivery (CD) in the second stage of labor, and whether use of nitroglycerin (NTG) during CD has a protective effect. We conducted a retrospective cohort study of women undergoing CD in the second stage of labor from 2012 to 2015. Some women received NTG at the obstetrician's request. Logistic regression was used to examine the relationship between second stage duration and NTG administration on maternal and neonatal outcomes. Of the 391 women in the sample, 27% had an extension and 12% received NTG. Second stage ≥4 h was associated with a 2.14-fold higher risk of extension (95% CI 1.22-3.75), a 2.00-fold higher risk of hemorrhage (95% CI: 1.20-3.33) and 2.42-fold higher risk of blood transfusion during delivery hospitalization (95% CI: 0.99-5.91). Intravenous (IV) and sublingual-spray (SL-spray) NTG administration were not associated with an increased risk of hemorrhage or extension. SL-NTG was associated with 4.68-fold increased odds of 5-min Apgar <7 (95% CI 1.42-15.41) and 3.36-fold greater odds of NICU admission (95% CI 1.20-9.41). We found no evidence that NTG protects against extension, and SL-NTG use was associated with adverse neonatal outcomes. Clinical trials should be conducted to evaluate risk and benefits of NTG use.

Uses of cancer registries for public health and clinical research in Europe: Results of the European Network of Cancer Registries survey among 161 population-based cancer registries during 2010-2012.

PubMed

Siesling, S; Louwman, W J; Kwast, A; van den Hurk, C; O'Callaghan, M; Rosso, S; Zanetti, R; Storm, H; Comber, H; Steliarova-Foucher, E; Coebergh, J W

2015-06-01

To provide insight into cancer registration coverage, data access and use in Europe. This contributes to data and infrastructure harmonisation and will foster a more prominent role of cancer registries (CRs) within public health, clinical policy and cancer research, whether within or outside the European Research Area. During 2010-12 an extensive survey of cancer registration practices and data use was conducted among 161 population-based CRs across Europe. Responding registries (66%) operated in 33 countries, including 23 with national coverage. Population-based oncological surveillance started during the 1940-50s in the northwest of Europe and from the 1970s to 1990s in other regions. The European Union (EU) protection regulations affected data access, especially in Germany and France, but less in the Netherlands or Belgium. Regular reports were produced by CRs on incidence rates (95%), survival (60%) and stage for selected tumours (80%). Evaluation of cancer control and quality of care remained modest except in a few dedicated CRs. Variables evaluated were support of clinical audits, monitoring adherence to clinical guidelines, improvement of cancer care and evaluation of mass cancer screening. Evaluation of diagnostic imaging tools was only occasional. Most population-based CRs are well equipped for strengthening cancer surveillance across Europe. Data quality and intensity of use depend on the role the cancer registry plays in the politico, oncomedical and public health setting within the country. Standard registration methodology could therefore not be translated to equivalent advances in cancer prevention and mass screening, quality of care, translational research of prognosis and survivorship across Europe. Further European collaboration remains essential to ensure access to data and comparability of the results. Copyright © 2014 Elsevier Ltd. All rights reserved.

Performance Evaluation of Extension Education Centers in Universities Based on the Balanced Scorecard

ERIC Educational Resources Information Center

Wu, Hung-Yi; Lin, Yi-Kuei; Chang, Chi-Hsiang

2011-01-01

This study aims at developing a set of appropriate performance evaluation indices mainly based on balanced scorecard (BSC) for extension education centers in universities by utilizing multiple criteria decision making (MCDM). Through literature reviews and experts who have real practical experiences in extension education, adequate performance…

Multiple Year Extension Program Outcomes & Impacts through Evaluation

ERIC Educational Resources Information Center

Hachfeld, Gary A.; Bau, David B.; Holcomb, C. Robert; Craig, J. William

2013-01-01

Dwindling public funding as well as greater competition for grant dollars create a challenge for Extension. For Extension to remain a financially viable organization, educators have to be able to produce substantive, measurable program outcomes and impacts. Evaluative data can inform program development and delivery, and helps administrators…

Extension Sustainability Camp: Design, Implementation, and Evaluation

ERIC Educational Resources Information Center

Brain, Roslynn; Upton, Sally; Tingey, Brett

2015-01-01

Sustainability Camps provide an opportunity for Extension educators to be in the forefront of sustainability outreach and to meet the growing demand for sustainability education. This article shares development, implementation, and evaluation of an Extension Sustainability Camp for youth, grades 4-6. Camp impact was measured via daily pre-and…

Safety and tolerability of vortioxetine (15 and 20 mg) in patients with major depressive disorder: results of an open-label, flexible-dose, 52-week extension study

PubMed Central

Jacobsen, Paula L.; Harper, Linda; Chrones, Lambros; Chan, Serena

2015-01-01

Vortioxetine is approved for the treatment of adults with major depressive disorder. This open-label extension (OLE) study evaluated the safety and tolerability of vortioxetine in the long-term treatment of major depressive disorder patients, as well as evaluated its effectiveness using measures of depression, anxiety, and overall functioning. This was a 52-week, flexible-dose, OLE study in patients who completed one of three randomized, double-blind, placebo-controlled, 8-week vortioxetine trials. All patients were switched to 10 mg/day vortioxetine for week 1, then adjusted between 15 and 20 mg for the remainder of the study, but not downtitrated below 15 mg. Safety and tolerability were assessed on the basis of treatment-emergent adverse events (TEAEs), vital signs, laboratory values, physical examination, and the Columbia-Suicide Severity Rating Scale. Efficacy measures included the Montgomery–Åsberg Depression Rating Scale, the Hamilton Anxiety Scale, the Clinical Global Impression Scale-Severity of Illness, and the Sheehan Disability Scale. Of the 1075 patients enrolled, 1073 received at least one dose of vortioxetine and 538 (50.0%) completed the study. A total of 537 patients withdrew early, with 115 (10.7% of the original study population) withdrawing because of TEAEs. Long-term treatment with vortioxetine was well tolerated; the most common TEAEs (≥10%) were nausea and headache. Laboratory values, vital signs, and physical examinations revealed no trends of clinical concern. The mean Montgomery–Åsberg Depression Rating Scale total score was 19.9 at the start of the extension study and 9.0 after 52 weeks of treatment (observed cases). Similar improvements were observed with the Hamilton Anxiety Scale (Δ−4.2), the Clinical Global Impression Scale-Severity of Illness (Δ−1.2), and the Sheehan Disability Scale (Δ−4.7) total scores after 52 weeks of treatment (observed case). In this 52-week, flexible-dose OLE study, 15 and 20 mg vortioxetine were safe and well tolerated. After entry into this study, patients continued to show improvement in depression and anxiety symptoms, as well as overall functioning, throughout the treatment period. PMID:26020712

Making Evaluation Work for You: Ideas for Deriving Multiple Benefits from Evaluation

ERIC Educational Resources Information Center

Jayaratne, K. S. U.

2016-01-01

Increased demand for accountability has forced Extension educators to evaluate their programs and document program impacts. Due to this situation, some Extension educators may view evaluation simply as the task, imposed on them by administrators, of collecting outcome and impact data for accountability. They do not perceive evaluation as a useful…

Radiographic versus clinical extension of Class II carious lesions using an F-speed film.

PubMed

Kooistra, Scott; Dennison, Joseph B; Yaman, Peter; Burt, Brian A; Taylor, George W

2005-01-01

This study investigated the difference in the apparent radiographic and true clinical extension of Class II carious lesions. Sixty-two lesions in both maxillary and mandibular premolars and molars were radiographed using Insight bitewing film. Class II lesions were scored independently by two masked examiners using an 8-point lesion severity scale. During the restoration process the lesions were dissected in a stepwise fashion from the occlusal aspect. Intraoperative photographs (2x) of the lesions were made, utilizing a novel measurement device in the field as a point of reference. Subsequently, the lesions were all given clinical scores using the same 8-point scale. Statistical analysis showed a significant difference between the true clinical extension of the lesions compared to the radiographic score. "Aggressive" and "Conservative" radiographic diagnoses underestimated the true clinical extent by 0.66 mm and 0.91 mm, respectively. No statistical difference was found between premolars and molars or maxillary and mandibular arches. The results of this study help to define the parameters for making restorative treatment decisions involving Class II carious lesions.

The Essential Medicinal Chemistry of Curcumin.

PubMed

Nelson, Kathryn M; Dahlin, Jayme L; Bisson, Jonathan; Graham, James; Pauli, Guido F; Walters, Michael A

2017-03-09

Curcumin is a constituent (up to ∼5%) of the traditional medicine known as turmeric. Interest in the therapeutic use of turmeric and the relative ease of isolation of curcuminoids has led to their extensive investigation. Curcumin has recently been classified as both a PAINS (pan-assay interference compounds) and an IMPS (invalid metabolic panaceas) candidate. The likely false activity of curcumin in vitro and in vivo has resulted in >120 clinical trials of curcuminoids against several diseases. No double-blinded, placebo controlled clinical trial of curcumin has been successful. This manuscript reviews the essential medicinal chemistry of curcumin and provides evidence that curcumin is an unstable, reactive, nonbioavailable compound and, therefore, a highly improbable lead. On the basis of this in-depth evaluation, potential new directions for research on curcuminoids are discussed.

The radiologist's workflow environment: evaluation of disruptors and potential implications.

PubMed

Yu, John-Paul J; Kansagra, Akash P; Mongan, John

2014-06-01

Workflow interruptions in the health care delivery environment are a major contributor to medical errors and have been extensively studied within numerous hospital settings, including the nursing environment and the operating room, along with their effects on physician workflow. Less understood, though, is the role of interruptions in other highly specialized clinical domains and subspecialty services, such as diagnostic radiology. The workflow of the on-call radiologist, in particular, is especially susceptible to disruption by telephone calls and other modes of physician-to-physician communication. Herein, the authors describe their initial efforts to quantify the degree of interruption experienced by on-call radiologists and examine its potential implications in patient safety and overall clinical care. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.

The Essential Medicinal Chemistry of Curcumin

PubMed Central

2017-01-01

Curcumin is a constituent (up to ∼5%) of the traditional medicine known as turmeric. Interest in the therapeutic use of turmeric and the relative ease of isolation of curcuminoids has led to their extensive investigation. Curcumin has recently been classified as both a PAINS (pan-assay interference compounds) and an IMPS (invalid metabolic panaceas) candidate. The likely false activity of curcumin in vitro and in vivo has resulted in >120 clinical trials of curcuminoids against several diseases. No double-blinded, placebo controlled clinical trial of curcumin has been successful. This manuscript reviews the essential medicinal chemistry of curcumin and provides evidence that curcumin is an unstable, reactive, nonbioavailable compound and, therefore, a highly improbable lead. On the basis of this in-depth evaluation, potential new directions for research on curcuminoids are discussed. PMID:28074653

PubMed Central

Giannantoni, N.M.; Minisci, M.; Brunetti, V.; Scarano, E.; Testani, E.; Vollono, C.; De Corso, E.; Bastanza, G.; D'Alatri, L.

2016-01-01

SUMMARY Oro-pharyngeal dysphagia is frequently present during the acute phase of stroke. The aim of the present study was to evaluate whether the recording of surface EMG using a nasopharyngeal (NP) electrode could be applied to evaluation of pharyngeal muscle activity in acute stroke patients and if this neurophysiological measure is related with clinical assessment of swallowing. Patients were examined and clinical severity was assessed with the National Institute of Health Stroke Scale (NIHSS) score; dysphagia was evaluated through bedside screening test using the Gugging Swallowing Scale (GUSS). Extension of the ischaemic lesion was measured by quantitative score, based on CT scan [Alberta Stroke Programme Early CT Score (ASPECTS)]. We analysed 70 patients; 50 were classified as dysphagic (Dys+), and 20 as non-dysphagic (Dys–). Each participant underwent a surface NP EMG recording performed with a NP electrode, made of a Teflon isolated steel catheter, with a length of 16 cm and a tip diameter of 1.5 mm. The electrode was inserted through the nasal cavity, rotated and positioned approximately 3 mm anteroinferior to the salpingo-palatine fold. At least four consecutive swallowing-induced EMG bursts were recorded and analysed for each participant. Swallowing always induced a repetitive, polyphasic burst of activation of the EMG, lasting around 0.25 to 1 sec, with an amplitude of around 100-600mV. Two parameters of the EMG potentials recorded with the NP electrode were analyzed: duration and amplitude. The duration of the EMG burst was increased in Dys+ patients with a statistically significant difference compared to Dys- patients (p < 0.001). The amplitude was slightly reduced in the Dys+ group, but statistically significant differences were not observed (p = 0,775). Nevertheless, the burst amplitude showed a significant inverse correlation with NIHSS [r(48) = –0.31; p < 0.05] and ASPECTS scores [r(48) = –0.27; p < 0.05], meaning that the burst amplitude progressively reduced with an increase of clinical severity (NIHSS) and topographic extension of brain lesions in CT (ASPECTS). These results suggest that NP recordings can give a semi-quantitative measure of swallowing difficulties originating from pharyngeal dysfunction, in fact, electromyographic findings suggest reduced pharyngeal motility. PMID:27734982

Extensions to decision curve analysis, a novel method for evaluating diagnostic tests, prediction models and molecular markers

PubMed Central

Vickers, Andrew J; Cronin, Angel M; Elkin, Elena B; Gonen, Mithat

2008-01-01

Background Decision curve analysis is a novel method for evaluating diagnostic tests, prediction models and molecular markers. It combines the mathematical simplicity of accuracy measures, such as sensitivity and specificity, with the clinical applicability of decision analytic approaches. Most critically, decision curve analysis can be applied directly to a data set, and does not require the sort of external data on costs, benefits and preferences typically required by traditional decision analytic techniques. Methods In this paper we present several extensions to decision curve analysis including correction for overfit, confidence intervals, application to censored data (including competing risk) and calculation of decision curves directly from predicted probabilities. All of these extensions are based on straightforward methods that have previously been described in the literature for application to analogous statistical techniques. Results Simulation studies showed that repeated 10-fold crossvalidation provided the best method for correcting a decision curve for overfit. The method for applying decision curves to censored data had little bias and coverage was excellent; for competing risk, decision curves were appropriately affected by the incidence of the competing risk and the association between the competing risk and the predictor of interest. Calculation of decision curves directly from predicted probabilities led to a smoothing of the decision curve. Conclusion Decision curve analysis can be easily extended to many of the applications common to performance measures for prediction models. Software to implement decision curve analysis is provided. PMID:19036144

Extensions to decision curve analysis, a novel method for evaluating diagnostic tests, prediction models and molecular markers.

PubMed

Vickers, Andrew J; Cronin, Angel M; Elkin, Elena B; Gonen, Mithat

2008-11-26

Decision curve analysis is a novel method for evaluating diagnostic tests, prediction models and molecular markers. It combines the mathematical simplicity of accuracy measures, such as sensitivity and specificity, with the clinical applicability of decision analytic approaches. Most critically, decision curve analysis can be applied directly to a data set, and does not require the sort of external data on costs, benefits and preferences typically required by traditional decision analytic techniques. In this paper we present several extensions to decision curve analysis including correction for overfit, confidence intervals, application to censored data (including competing risk) and calculation of decision curves directly from predicted probabilities. All of these extensions are based on straightforward methods that have previously been described in the literature for application to analogous statistical techniques. Simulation studies showed that repeated 10-fold crossvalidation provided the best method for correcting a decision curve for overfit. The method for applying decision curves to censored data had little bias and coverage was excellent; for competing risk, decision curves were appropriately affected by the incidence of the competing risk and the association between the competing risk and the predictor of interest. Calculation of decision curves directly from predicted probabilities led to a smoothing of the decision curve. Decision curve analysis can be easily extended to many of the applications common to performance measures for prediction models. Software to implement decision curve analysis is provided.

Functional MR imaging and traumatic paraplegia: preliminary report.

PubMed

Sabbah, P; Lévêque, C; Pfefer, F; Nioche, C; Gay, S; Sarrazin, J L; Barouti, H; Tadie, M; Cordoliani, Y S

2000-12-01

To evaluate residual activity in the sensorimotor cortex of the lower limbs in paraplegia. 5 patients suffering from a complete paralysis after traumatic medullar lesion (ASIA=A). Clinical evaluation of motility and sensitivity. 1. Control functional MR study of the sensorimotor cortex during simultaneous movements of hands, imaginary motor task and passive hands stimulation. 2. Concerning the lower limbs, 3 fMRI conditions: 1-patient attempts to move his toes with flexion-extension, 2-mental imagery task of the same movement, 3-peripheral passive proprio-somesthesic stimulation (squeezing) of the big toes. Activations were observed in the primary sensorimotor cortex (M1), premotor regions and in the supplementary motor area (SMA) during movement and mental imaginary tasks in the control study and during attempt to move and mental imaginary tasks in the study concerning the lower limbs. Passive somesthesic stimulation generated activation posterior to the central sulcus for 2 patients. Activations in the sensorimotor cortex of the lower limbs can be generated either by attempting to move or mental evocation. In spite of a clinical evaluation of complete paraplegia, fMRI can show a persistence of sensitive anatomic conduction, confirmed by Somesthesic Evoked Potentials.

Upper limb robotics applied to neurorehabilitation: An overview of clinical practice.

PubMed

Duret, Christophe; Mazzoleni, Stefano

2017-01-01

During the last two decades, extensive interaction between clinicians and engineers has led to the development of systems that stimulate neural plasticity to optimize motor recovery after neurological lesions. This has resulted in the expansion of the field of robotics for rehabilitation. Studies in patients with stroke-related upper-limb paresis have shown that robotic rehabilitation can improve motor capacity. However, few other applications have been evaluated (e.g. tremor, peripheral nerve injuries or other neurological diseases). This paper presents an overview of the current use of upper limb robotic systems for neurorehabilitation, and highlights the rationale behind their use for the assessment and treatment of common neurological disorders. Rehabilitation robots are little integrated in clinical practice, except after stroke. Although few studies have been carried out to evaluate their effectiveness, evidence from the neurosciences and indications from pilot studies suggests that upper limb robotic rehabilitation can be applied safely in various other neurological conditions. Rehabilitation robots provide an intensity, quality and dose of treatment that exceeds therapist-mediated rehabilitation. Moreover, the use of force fields, multi-sensory environments, feedback etc. renders such rehabilitation engaging and motivating. Future studies should evaluate the effectiveness of rehabilitation robots in neurological pathologies other than stroke.

Primary hyperparathyroidism: recent advances.

PubMed

Walker, Marcella D; Bilezikian, John P

2018-07-01

The purpose of this review is to describe recent advances and changes in the evaluation and management of primary hyperparathyroidism (PHPT). Although it has long been recognized that asymptomatic PHPT is associated with bone loss, particularly at cortical skeletal sites when evaluated with dual-energy X-ray absorptiometry, new imaging techniques suggest that trabecular skeletal deterioration as well as clinically silent vertebral fractures and nephrolithiasis are common. Nonclassical targets of asymptomatic PHPT as well as the effect of vitamin D deficiency and treatment upon PHPT presentation have been the subject of recent intense investigation. Randomized clinical trials are now available regarding the effect of parathyroidectomy (PTX) upon both classical and nonclassical target organs. They have confirmed results from observational studies with regard to the skeletal benefits of PTX but have not consistently shown improvements in nonclassical symptoms. These findings have led to recommendations for more extensive renal and skeletal evaluation and broader criteria for PTX in PHPT. In addition to dual-energy X-ray absorptiometry, vertebral and renal imaging is recommended. When available, trabecular imaging techniques may be helpful. PTX criteria now include subclinical kidney stones, vertebral fractures and hypercalciuria, in addition to those based on age, serum calcium, bone densitometry and renal function.

Postoperative evaluation for intracranial recurrence of medulloblastoma: MR findings with Gadopentetate dimeglumine

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

Meyers, S.P.; Wildenhain, S.; Chess, M.A.

1994-09-01

Purpose: To characterize the gadopentetate dimeglumine-enhanced MR features of recurrent medulloblastoma. Methods: The postsurgical gadopentetate dimeglumine-enhanced MR images of 48 patients (206 head examinations) with prior resection of medulloblastoma were retrospectively evaluated for enhancement in the brain parenchyma, meninges (dura, pia-arachnoid), and ventricles. Results: Nineteen patients had recurrent tumor as determined by clinical course and positive imaging studies. Seventeen patients with recurrent disease had intracranial enhancement predominating in the pia-arachnoid (63%) or as a focal nodular brain lesion (26%). Three of these patients also had intraventricular metastases. None of the clinically healthy patients had these findings. One patient with recurrentmore » disease had extensive skeletal metastases without involvement of the central nervous system. Dural enhancement was observed in patients both with (42%) and without (38%) recurrent tumor. Conclusion: The MR findings of pia-arachnoidal or focal nodular brain enhancement are highly specific in the diagnosis of recurrent medulloblastoma. Pia-arachnodal or focal nodular brain enhancement were also a reliable indicator of recurrent medulloblastoma. Not all intraventricular metastases enhance with gadopentetate dimeglumine, and careful evaluation for nonenhancing lesions within the ventricles should be made on postoperative MR examines. 27 refs., 11 figs., 1 tab.« less

Retrospective Analysis of 255 Papillary Thyroid Carcinomas ≤2 cm: Clinicohistological Features and Prognostic Factors.

PubMed

Marques, Pedro; Leite, Valeriano; Bugalho, Maria João

2014-12-01

Papillary thyroid carcinoma (PTC) is the most common thyroid cancer. The widespread use of neck ultrasound (US) and US-guided fine-needle aspiration cytology is triggering an overdiagnosis of PTC. To evaluate clinical behavior and outcomes of patients with PTCs ≤2 cm, seeking for possible prognostic factors. Clinical records of cases with histological diagnosis of PTC ≤2 cm followed at the Endocrine Department of Instituto Português de Oncologia, Lisbon between 2002 and 2006 were analyzed retrospectively. We identified 255 PTCs, 111 were microcarcinomas. Most patients underwent near-total thyroidectomy, with lymph node dissections in 55 cases (21.6%). Radioiodine therapy was administered in 184 patients. At the last evaluation, 38 (14.9%) had evidence of disease. Two deaths were attributed to PTC. Median (±SD) follow-up was 74 (±23) months. Multivariate analysis identified vascular invasion, lymph node and systemic metastases significantly associated with recurrence/persistence of disease. In addition, lymph node involvement was significantly associated with extrathyroidal extension and angioinvasion. Median (±SD) disease-free survival (DFS) was estimated as 106 (±3) months and the 5-year DFS rate was 87.5%. Univariate Cox analysis identified some relevant parameters for DFS, but multivariate regression only identified lymph node and systemic metastases as significant independent factors. The median DFS estimated for lymph node and systemic metastases was 75 and 0 months, respectively. In the setting of small PTCs, vascular invasion, extrathyroidal extension and lymph node and/or systemic metastases may confer worse prognosis, perhaps justifying more aggressive therapeutic and follow-up approaches in such cases.

Budesonide Foam Has a Favorable Safety Profile for Inducing Remission in Mild-to-Moderate Ulcerative Proctitis or Proctosigmoiditis.

PubMed

Rubin, David T; Sandborn, William J; Bosworth, Brian; Zakko, Salam; Gordon, Glenn L; Sale, Mark E; Rolleri, Robert L; Golden, Pamela L; Barrett, Andrew C; Bortey, Enoch; Forbes, William P

2015-11-01

Budesonide foam, a rectally administered, second-generation corticosteroid with extensive hepatic first-pass metabolism, is efficacious for the treatment of mild-to-moderate ulcerative proctitis and ulcerative proctosigmoiditis. The aim of this study was to comprehensively assess the safety and pharmacokinetic profile of budesonide foam. Data from five phase III studies were pooled to further evaluate safety, including an open-label study (once-daily treatment for 8 weeks), an active-comparator study (once-daily treatment for 4 weeks), and two placebo-controlled studies and an open-label extension study (twice-daily treatment for 2 weeks, then once daily for 4 weeks). Data from the placebo-controlled studies and two phase I studies (i.e., patients with mild-to-moderate ulcerative colitis and healthy volunteers) were pooled to evaluate the pharmacokinetics of budesonide foam. A similar percentage of patients reported adverse events in the budesonide foam and placebo groups, with the majority of adverse events being mild or moderate in intensity (93.3 vs 96.0%, respectively). Adverse events occurred in 41.4 and 36.3% of patients receiving budesonide foam and placebo, respectively. Mean morning cortisol concentrations remained within the normal range for up to 8 weeks of treatment; there were no clinically relevant effects of budesonide foam on the hypothalamic-pituitary-adrenal axis. Population pharmacokinetic analysis demonstrated low systemic exposure after budesonide foam administration. This integrated analysis demonstrated that budesonide foam for the induction of remission of distal ulcerative colitis is safe overall, with no clinically relevant effects on the hypothalamic-pituitary-adrenal axis.

Identification of filamentous fungi isolates by MALDI-TOF mass spectrometry: clinical evaluation of an extended reference spectra library.

PubMed

Becker, Pierre T; de Bel, Annelies; Martiny, Delphine; Ranque, Stéphane; Piarroux, Renaud; Cassagne, Carole; Detandt, Monique; Hendrickx, Marijke

2014-11-01

The identification of filamentous fungi by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) relies mainly on a robust and extensive database of reference spectra. To this end, a large in-house library containing 760 strains and representing 472 species was built and evaluated on 390 clinical isolates by comparing MALDI-TOF MS with the classical identification method based on morphological observations. The use of MALDI-TOF MS resulted in the correct identification of 95.4% of the isolates at species level, without considering LogScore values. Taking into account the Brukers' cutoff value for reliability (LogScore >1.70), 85.6% of the isolates were correctly identified. For a number of isolates, microscopic identification was limited to the genus, resulting in only 61.5% of the isolates correctly identified at species level while the correctness reached 94.6% at genus level. Using this extended in-house database, MALDI-TOF MS thus appears superior to morphology in order to obtain a robust and accurate identification of filamentous fungi. A continuous extension of the library is however necessary to further improve its reliability. Indeed, 15 isolates were still not represented while an additional three isolates were not recognized, probably because of a lack of intraspecific variability of the corresponding species in the database. © The Author 2014. Published by Oxford University Press on behalf of The International Society for Human and Animal Mycology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Ambrisentan response in connective tissue disease-associated pulmonary arterial hypertension (CTD-PAH) - A subgroup analysis of the ARIES-E clinical trial.

PubMed

Fischer, Aryeh; Denton, Christopher P; Matucci-Cerinic, Marco; Gillies, Hunter; Blair, Christiana; Tislow, James; Nathan, Steven D

2016-08-01

Pulmonary arterial hypertension (PAH) is a condition which may lead to right ventricular failure and early mortality and is an important complication in patients with connective tissue disease (CTD). Previously, the endothelin A selective receptor antagonist, ambrisentan, demonstrated efficacy and safety in treating patients with PAH due to WHO Group I etiologies. These analyses describe the 3-year efficacy and safety of ambrisentan in patients specifically with CTD associated PAH (CTD-PAH). Patients with CTD-PAH participating in the ARIES-1 and -2 clinical trials and their long-term extension were evaluated. Efficacy evaluations including 6-min walk distance (6MWD), clinical worsening, and survival were collected at routine study visits. Additional analyses of 6MWD categorical (30 m) breakpoints were conducted to determine any relationship between 6MWD and a prognostic threshold for survival. 124 patients with CTD-PAH were evaluated. 62.6%, 57.3%, and 58.2% of CTD-PAH patients treated with ambrisentan exhibited increases in 6MWD at 1-, 2-, and 3- years respectively. At 3 years, 64% of patients were free from clinical worsening and 76% of patients were still alive (Kaplan-Meier estimates). Identified factors holding prognostic relevance for survival include: baseline functional class, CTD-PAH subgroup, patient sex, improvement in 6MWD ≥30 m over the first 12 weeks of treatment, the most recent 6MWD, and a 6MWD absolute threshold of 222 m. These first analyses of the 3-year treatment of CTD-PAH patients with ambrisentan revealed fewer clinical worsening events and improved survival compared to historical controls. Key exercise parameters were also identified which appear important in guiding treatment. Copyright © 2016 Elsevier Ltd. All rights reserved.

Drug-drug interactions involving lysosomes: mechanisms and potential clinical implications.

PubMed

Logan, Randall; Funk, Ryan S; Axcell, Erick; Krise, Jeffrey P

2012-08-01

Many commercially available, weakly basic drugs have been shown to be lysosomotropic, meaning they are subject to extensive sequestration in lysosomes through an ion trapping-type mechanism. The extent of lysosomal trapping of a drug is an important therapeutic consideration because it can influence both activity and pharmacokinetic disposition. The administration of certain drugs can alter lysosomes such that their accumulation capacity for co-administered and/or secondarily administered drugs is altered. In this review the authors explore what is known regarding the mechanistic basis for drug-drug interactions involving lysosomes. Specifically, the authors address the influence of drugs on lysosomal pH, volume and lipid processing. Many drugs are known to extensively accumulate in lysosomes and significantly alter their structure and function; however, the therapeutic and toxicological implications of this remain controversial. The authors propose that drug-drug interactions involving lysosomes represent an important potential source of variability in drug activity and pharmacokinetics. Most evaluations of drug-drug interactions involving lysosomes have been performed in cultured cells and isolated tissues. More comprehensive in vivo evaluations are needed to fully explore the impact of this drug-drug interaction pathway on therapeutic outcomes.

Finger extension weakness and downbeat nystagmus motor neuron disease syndrome: A novel motor neuron disorder?

PubMed

Delva, Aline; Thakore, Nimish; Pioro, Erik P; Poesen, Koen; Saunders-Pullman, Rachel; Meijer, Inge A; Rucker, Janet C; Kissel, John T; Van Damme, Philip

2017-12-01

Disturbances of eye movements are infrequently encountered in motor neuron diseases (MNDs) or motor neuropathies, and there is no known syndrome that combines progressive muscle weakness with downbeat nystagmus. To describe the core clinical features of a syndrome of MND associated with downbeat nystagmus, clinical features were collected from 6 patients. All patients had slowly progressive muscle weakness and wasting in combination with downbeat nystagmus, which was clinically most obvious in downward and lateral gaze. Onset was in the second to fourth decade with finger extension weakness, progressing to other distal and sometimes more proximal muscles. Visual complaints were not always present. Electrodiagnostic testing showed signs of regional motor axonal loss in all patients. The etiology of this syndrome remains elusive. Because finger extension weakness and downbeat nystagmus are the discriminating clinical features of this MND, we propose the name FEWDON-MND syndrome. Muscle Nerve 56: 1164-1168, 2017. © 2017 The Authors Muscle & Nerve Published by Wiley Periodicals, Inc.

Finger extension weakness and downbeat nystagmus motor neuron disease syndrome: A novel motor neuron disorder?

PubMed Central

Delva, Aline; Thakore, Nimish; Pioro, Erik P.; Poesen, Koen; Saunders‐Pullman, Rachel; Meijer, Inge A.; Rucker, Janet C.; Kissel, John T.

2017-01-01

ABSTACT Introduction: Disturbances of eye movements are infrequently encountered in motor neuron diseases (MNDs) or motor neuropathies, and there is no known syndrome that combines progressive muscle weakness with downbeat nystagmus. Methods: To describe the core clinical features of a syndrome of MND associated with downbeat nystagmus, clinical features were collected from 6 patients. Results: All patients had slowly progressive muscle weakness and wasting in combination with downbeat nystagmus, which was clinically most obvious in downward and lateral gaze. Onset was in the second to fourth decade with finger extension weakness, progressing to other distal and sometimes more proximal muscles. Visual complaints were not always present. Electrodiagnostic testing showed signs of regional motor axonal loss in all patients. Discussion: The etiology of this syndrome remains elusive. Because finger extension weakness and downbeat nystagmus are the discriminating clinical features of this MND, we propose the name FEWDON‐MND syndrome. Muscle Nerve 56: 1164–1168, 2017 PMID:28440863

Pirfenidone: an update on clinical trial data and insights from everyday practice.

PubMed

Kreuter, Michael

2014-03-01

Pirfenidone is an orally active, small molecule that inhibits synthesis of profibrotic and inflammatory mediators. It was approved for the treatment of adults with mild-to-moderate idiopathic pulmonary fibrosis in the European Union based on the results of two pivotal phase III, double-blind, randomised, placebo-controlled clinical trials (CAPACITY) demonstrating efficacy and safety, and supported by two Japanese clinical trials (SP2 and SP3). Currently, there is increasing interest in experience with pirfenidone in patients relating to the real-world setting. Following the publication of the CAPACITY clinical studies, additional analyses have been conducted to provide further support for pirfenidone in clinical practice, including a modified per-protocol analysis of the CAPACITY study population. New data from the RECAP extension study also provided longer term data for pirfenidone and promising continuation rates with treatment. Pirfenidone is also being evaluated in specialist centre cohorts providing important information on real-world efficacy and safety. Increasing experience with pirfenidone in everyday clinical practice is helping to establish \\expert guidance on the management of known adverse events, together with practical recommendations, to ensure adherence to treatment so that the possible longer term benefits of pirfenidone treatment in reducing lung function decline can be maximised.

Adolescent bariatric surgery program characteristics: the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study experience.

PubMed

Michalsky, Marc P; Inge, Thomas H; Teich, Steven; Eneli, Ihuoma; Miller, Rosemary; Brandt, Mary L; Helmrath, Michael; Harmon, Carroll M; Zeller, Meg H; Jenkins, Todd M; Courcoulas, Anita; Buncher, Ralph C

2014-02-01

The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Data were obtained from the Teen-LABS database, and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. All centers had extensive multidisciplinary involvement in the assessment, pre-operative education, and post-operative management of adolescents undergoing WLS. Eligibility criteria and pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well-developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. The composition of clinical team and institutional resources is consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. © 2013 Published by Elsevier Inc.

Adolescent Bariatric Surgery Program Characteristics: The Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) Study Experience

PubMed Central

Michalsky, M.P.; Inge, T.H.; Teich, S.; Eneli, I.; Miller, R.; Brandt, M.L.; Helmrath, M.; Harmon, C.M.; Zeller, M.H.; Jenkins, T.M.; Courcoulas, A.; Buncher, C.R.

2013-01-01

Background The number of adolescents undergoing weight loss surgery (WLS) has increased in response to the increasing prevalence of severe childhood obesity. Adolescents undergoing WLS require unique support, which may differ from adult programs. The aim of this study was to describe institutional and programmatic characteristics of centers participating in Teen-Longitudinal Assessment of Bariatric Surgery (Teen-LABS), a prospective study investigating safety and efficacy of adolescent WLS. Methods Data were obtained from the Teen-LABS database and site survey completed by Teen-LABS investigators. The survey queried (1) institutional characteristics, (2) multidisciplinary team composition, (3) clinical program characteristics, and (4) clinical research infrastructure. Results All centers had extensive multidisciplinary involvement in the assessment, preoperative education and post-operative management of adolescents undergoing WLS. Eligibility criteria, pre-operative clinical and diagnostic evaluations were similar between programs. All programs have well developed clinical research infrastructure, use adolescent-specific educational resources, and maintain specialty equipment, including high weight capacity diagnostic imaging equipment. Conclusions The composition of clinical team and institutional resources are consistent with current clinical practice guidelines. These characteristics, coupled with dedicated research staff, have facilitated enrollment of 242 participants into Teen-LABS. PMID:24491361

WE-F-BRB-01: The Power of Ontologies and Standardized Terminologies for Capturing Clinical Knowledge

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

Gabriel, P.

2015-06-15

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, itmore » is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.« less

The effects of lumbar extensor strength on disability and mobility in patients with persistent low back pain.

PubMed

Helmhout, Pieter H; Witjes, Marloes; Nijhuis-VAN DER Sanden, Ria W; Bron, Carel; van Aalst, Michiel; Staal, J Bart

2017-04-01

It is assumed that low back pain patients who use pain-avoiding immobilizing strategies may benefit from specific back flexion and extension exercises aimed at reducing sagittal lumbar hypomobility. The aim of this study was to test this potential working mechanism in chronic low back pain patients undergoing lumbar extensor strengthening training. A single-group prospective cohort design was used in this study. Patients with persistent low back complaints for at least 2 years were recruited at a specialized physical therapy clinics center. They participated in a progressive 11-week lumbar extensor strength training program, once a week. At baseline, sagittal lumbar mobility in flexion and extension was measured with a computer-assisted inclinometer. Self-rated pain intensity was measured using a visual analogue scale, back-specific functional status was assessed with the Quebec Back Pain Disability Scale and the Patient Specific Complains questionnaire. Statistically significant improvements were found in pain (28% decrease) and functional disability (23% to 36% decrease). Most progress was seen in the first 5 treatment weeks. Lumbar mobility in flexion showed non-significant increases over time (+12%). Pre-post treatment changes in flexion and extension mobility did not contribute significantly to the models. The retained factors together explained 15% to 48% of the variation in outcome. Specific lumbar strengthening showed clinically relevant improvements in pain and disability in patients with persistent chronic low back pain. These improvements did not necessarily relate to improvements in lumbar mobility. Parameters representing other domains of adaptations to exercise may be needed to evaluate the effects of back pain management.

Decreased muscle strength is associated with impaired long-term functional outcome after intramedullary nailing of femoral shaft fracture.

PubMed

Larsen, P; Elsoe, R; Graven-Nielsen, T; Laessoe, U; Rasmussen, S

2015-12-01

To examine the long-term outcome after intramedullary nailing of femoral diaphysial fractures measured as disease-specific patient reported function, walking ability, muscle strength, pain and quality of life (QOL). Cross-sectional study. Retrospective review and follow-up with clinical examination of 48 patients treated with intramedullary nailing after femoral shaft fracture between 2007 and 2010. The patients underwent a clinical examination and assessment of walking ability, maximal muscle strength during knee flexion and extension and hip abduction. Hip disability and Osteoarthritis Outcome Score (HOOS) and questionnaire evaluating QOL (Eq5D-5L) were completed by patients. Fourty-eight patients agreed to participate. Mean time for follow-up was 4.7 years. The mean HOOS scores were 84.9 (Pain), 86.6 (ADL), 85.0 (Symptoms), 72.6 (QOL), and 69.1 (Sport). The mean muscle strength of knee flexion with the injured leg (226.0 N) was significantly lower then knee flexion with the non-injured leg (259.5 N, P < 0.0001). Likewise for knee extension (335.2 vs 406.4 N, P < 0.001) and hip abduction (129.2 vs 156.0 N, P < 0.001). Significant association between HOOS and an increase in the difference in muscle strength were observed as well as between worse HOOS outcome and increasing body mass index. This study showed that decreased muscle strength for knee flexion, knee extension and hip abduction was associated with worse long-term functional outcome measured with a disease-specific questionnaire (HOOS) after intramedullary nailing of femoral shaft fracture.

Online Extensive Reading for Advanced Foreign Language Learners: An Evaluation Study

ERIC Educational Resources Information Center

Arnold, Nike

2009-01-01

The following article reports the findings of a qualitative evaluation of an online extensive reading program in German as a foreign language. Designed for advanced learners, it differs from traditional extensive reading programs in two important aspects: students read online instead of printed materials, and there was no teacher preselection to…

Use of a porcine collagen matrix as an alternative to autogenous tissue for grafting oral soft tissue defects.

PubMed

Herford, Alan S; Akin, Lee; Cicciu, Marco; Maiorana, Carlo; Boyne, Philip J

2010-07-01

Soft tissue grafting is often required to correct intraoral mucosal deficiencies. Autogenous grafts have disadvantages including an additional harvest site with its associated pain and morbidity and, sometimes, poor quality and limited amount of the graft. Porcine collagen matrices have the potential to be helpful for grafting of soft tissue defects. Thirty consecutive patients underwent intraoral grafting to re-create missing soft tissue. Defects ranged in size from 50 to 900 mm(2). Porcine collagen matrices were used to reconstruct missing tissue. Indications included preprosthetic (22), followed by tumor removal (5), trauma (2), and release of cheek ankylosis (1). The primary efficacy parameters evaluated were the degree of lateral and/or alveolar extension and the evaluation of re-epithelialization and shrinkage of the grafted area. Overall, the percentage of shrinkage of the graft was 14% (range, 5%-20%). The amount of soft tissue extension averaged 3.4 mm (range, 2-10 mm). The secondary efficacy parameters included hemostatic effect, pain evaluation, pain and discomfort, and clinical evaluation of the grafted site. All patients reported minimal pain and swelling associated with the grafted area. No infections were noted. This porcine collagen matrix provides a biocompatible surgical material as an alternative to an autogenous transplant, thus obviating the need to harvest soft tissue autogenous grafts from other areas of the oral cavity. Copyright 2010 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Comparative abilities of Microsoft Kinect and Vicon 3D motion capture for gait analysis.

PubMed

Pfister, Alexandra; West, Alexandre M; Bronner, Shaw; Noah, Jack Adam

2014-07-01

Biomechanical analysis is a powerful tool in the evaluation of movement dysfunction in orthopaedic and neurologic populations. Three-dimensional (3D) motion capture systems are widely used, accurate systems, but are costly and not available in many clinical settings. The Microsoft Kinect™ has the potential to be used as an alternative low-cost motion analysis tool. The purpose of this study was to assess concurrent validity of the Kinect™ with Brekel Kinect software in comparison to Vicon Nexus during sagittal plane gait kinematics. Twenty healthy adults (nine male, 11 female) were tracked while walking and jogging at three velocities on a treadmill. Concurrent hip and knee peak flexion and extension and stride timing measurements were compared between Vicon and Kinect™. Although Kinect measurements were representative of normal gait, the Kinect™ generally under-estimated joint flexion and over-estimated extension. Kinect™ and Vicon hip angular displacement correlation was very low and error was large. Kinect™ knee measurements were somewhat better than hip, but were not consistent enough for clinical assessment. Correlation between Kinect™ and Vicon stride timing was high and error was fairly small. Variability in Kinect™ measurements was smallest at the slowest velocity. The Kinect™ has basic motion capture capabilities and with some minor adjustments will be an acceptable tool to measure stride timing, but sophisticated advances in software and hardware are necessary to improve Kinect™ sensitivity before it can be implemented for clinical use.

Evaluation of transradial body-powered prostheses using a robotic simulator.

PubMed

Ayub, Rafi; Villarreal, Dario; Gregg, Robert D; Gao, Fan

2017-04-01

Transradial body-powered prostheses are extensively used by upper-limb amputees. This prosthesis requires large muscle forces and great concentration by the patient, often leading to discomfort, muscle fatigue, and skin breakdown, limiting the capacity of the amputee to conduct daily activities. Since body-powered prostheses are commonplace, understanding their optimal operation to mitigate these drawbacks would be clinically meaningful. To find the optimal operation of the prosthesis where the activation force is minimized and the grip force is maximized. Experimental design. A computer-controlled robotic amputee simulator capable of rapidly testing multiple elbow, shoulder, and scapular combinations of the residual human arm was constructed. It was fitted with a transradial prosthesis and used to systematically test multiple configurations. We found that increased shoulder flexion, scapular abduction, elbow extension, and the placement of the ring harness near the vertebra C7 correlate with higher gripper operation efficiency, defined as the ratio of grip force to cable tension. We conclude that force transmission efficiency is closely related to body posture configuration. These results could help guide practitioners in clinical practice as well as motivate future studies in optimizing the operation of a body-powered prosthesis. Clinical relevance The results from this study suggest that clinicians ought to place the ring harness inferior and to the sound side of the vertebra prominens in order to maximize grip efficiency. The results will also help clinicians better instruct patients in body posture during prosthesis operation to minimize strain.

Recipients of CCITLA Announced

Cancer.gov

NCI’s Cancer Clinical Investigator Team Leadership Awards recognize and support outstanding mid-career clinical investigators at NCI-Designated Cancer Centers who participate extensively in NCI-funded collaborative clinical trials and whose leadership, pa

Design of a composite wing extension for a general aviation aircraft

NASA Technical Reports Server (NTRS)

Adney, P. S.; Horn, W. J.

1984-01-01

A composite wing extension was designed for a typical general aviation aircraft to improve lift curve slope, dihedral effect, and lift to drag ratio. Advanced composite materials were used in the design to evaluate their use as primary structural components in general aviation aircraft. Extensive wind tunnel tests were used to evaluate six extension shapes. The extension shape chosen as the best choice was 28 inches long with a total area of 17 square feet. Subsequent flight tests showed the wing extension's predicted aerodynamic improvements to be correct. The structural design of the wing extension consisted of a hybrid laminate carbon core with outer layers of Kevlar - layed up over a foam interior which acted as an internal support. The laminate skin of the wing extension was designed from strength requirements, and the foam core was included to prevent buckling. A joint lap was recommended to attach the wing extension to the main wing structure.

Improving validation methods for molecular diagnostics: application of Bland-Altman, Deming and simple linear regression analyses in assay comparison and evaluation for next-generation sequencing

PubMed Central

Misyura, Maksym; Sukhai, Mahadeo A; Kulasignam, Vathany; Zhang, Tong; Kamel-Reid, Suzanne; Stockley, Tracy L

2018-01-01

Aims A standard approach in test evaluation is to compare results of the assay in validation to results from previously validated methods. For quantitative molecular diagnostic assays, comparison of test values is often performed using simple linear regression and the coefficient of determination (R2), using R2 as the primary metric of assay agreement. However, the use of R2 alone does not adequately quantify constant or proportional errors required for optimal test evaluation. More extensive statistical approaches, such as Bland-Altman and expanded interpretation of linear regression methods, can be used to more thoroughly compare data from quantitative molecular assays. Methods We present the application of Bland-Altman and linear regression statistical methods to evaluate quantitative outputs from next-generation sequencing assays (NGS). NGS-derived data sets from assay validation experiments were used to demonstrate the utility of the statistical methods. Results Both Bland-Altman and linear regression were able to detect the presence and magnitude of constant and proportional error in quantitative values of NGS data. Deming linear regression was used in the context of assay comparison studies, while simple linear regression was used to analyse serial dilution data. Bland-Altman statistical approach was also adapted to quantify assay accuracy, including constant and proportional errors, and precision where theoretical and empirical values were known. Conclusions The complementary application of the statistical methods described in this manuscript enables more extensive evaluation of performance characteristics of quantitative molecular assays, prior to implementation in the clinical molecular laboratory. PMID:28747393

Evaluation of the 'Fitting to Outcomes eXpert' (FOX®) with established cochlear implant users.

PubMed

Buechner, Andreas; Vaerenberg, Bart; Gazibegovic, Dzemal; Brendel, Martina; De Ceulaer, Geert; Govaerts, Paul; Lenarz, Thomas

2015-01-01

To evaluate the possible impact of 'Fitting to Outcomes eXpert (FOX(®))' on cochlear implant (CI) fitting in a clinic with extensive experience of fitting a range of CI systems, as a way to assess whether a software tool such as FOX is able to complement standard clinical procedures. Ten adult post-lingually deafened and unilateral long-term users of the Advanced Bionics(TM) CI system (Clarion CII or HiRes 90K(TM)) underwent speech perception assessment with their current clinical program. One cycle 'iteration' of FOX optimization was performed and the program adjusted accordingly. After a month of using both clinical and FOX programs, a second iteration of FOX optimization was performed. Following this, the assessments were repeated without further acclimatization. FOX prescribed programming modifications in all subjects. Soundfield-aided thresholds were significantly lower for FOX than the clinical program. Group speech scores in noise were not significantly different between the two programs but three individual subjects had improved speech scores with the FOX MAP, two had worse speech scores, and five were the same. FOX provided a standardized approach to fitting based on outcome measures rather than comfort alone. The results indicated that for this group of well-fitted patients, FOX improved outcomes in some individuals. There were significant changes, both better and worse, in individual speech perception scores but median scores remained unchanged. Soundfield-aided thresholds were significantly improved for the FOX group.

Effect of Cervical Sagittal Balance on Laminoplasty in Patients With Cervical Myelopathy

PubMed Central

Namikawa, Takashi; Matsumura, Akira; Konishi, Sadahiko; Nakamura, Hiroaki

2017-01-01

Study Design: Retrospective clinical study. Objective: We evaluated the relationship between cervical sagittal alignment parameters and clinical status in patients with cervical myelopathy and analyzed the effect of cervical sagittal balance on cervical laminoplasty. Methods: Patients with cervical myelopathy (n = 110) who underwent laminoplasty were included in this study. The relationship between cervical sagittal alignment parameters and clinical status was evaluated. The changes in radiographic cervical sagittal parameters and clinical status 2 years after surgery were compared between patients with preoperative C2-7 SVA ≥35 mm (group A) and those with preoperative C2-7 SVA <35 mm (group B). Results: Preoperatively, C2-7 SVA had no correlation with defined health-related quality of life evaluation scores. At 2-year follow-up, the improvement in SF-36 physical component summary was significantly lower in group A than in group B. The postoperative change of C2-7 SVA did not significantly differ in 2 groups. Patients in group A maintained cervical regional balance after laminoplasty but experienced extensive postoperative neck pain. Conclusions: Our patients with a C2-7 SVA of ≥35 mm maintained cervical regional balance after laminoplasty and their improvement in myelopathy was equivalent to that in patients with a C2-7 SVA of <35 mm. However, the patents with a C2-7 SVA of ≥35 mm experienced severe postoperative neck pain. C2-7 SVA is a parameter worth considering because it can lead to poor QOL and axial neck pain after laminoplasty. PMID:28507885

Effects of initial graft tension on femoral tunnel widening after anatomic anterior cruciate ligament reconstruction using a bone-patellar tendon-bone graft.

PubMed

Taketomi, Shuji; Inui, Hiroshi; Tahara, Keitaro; Shirakawa, Nobuyuki; Tanaka, Sakae; Nakagawa, Takumi

2017-09-01

The effects of initial graft tension upon tunnel widening (TW) following anatomic anterior cruciate ligament (ACL) reconstruction have not been elucidated. The purpose of this study was to retrospectively investigate the effect of two different graft-tensioning protocols upon femoral TW following anatomic ACL reconstruction using a bone-patellar tendon-bone (BPTB) graft and a three-dimensional (3D) computed tomography (CT) model. Forty-three patients who underwent isolated ACL reconstruction using BPTB grafts were included in this study. In 18 out of the 43 patients, the graft was fixed at full knee extension with manual maximum pull (Group H). These patients were compared with 25 patients in whom the BPTB graft was fixed at full knee extension with 80-N pull (Group L). Tunnel aperture area was measured using 3D CT 1 week and 1 year postoperatively, thus enabling us to calculate the percentage change in the area of femoral tunnel aperture. Clinical assessment was performed 1 year postoperatively, corresponding to the time period of CT assessment, and involved the evaluation of Lysholm score, anterior knee stability using a KneeLax3 arthrometer, and the pivot-shift test. When measured at 1 year postoperatively, the mean area of the femoral tunnel aperture had increased by 78.6 ± 36.8% in Group H when compared with at 1 week postoperatively, whereas that of Group L had increased by 27.7 ± 32.3%. Furthermore, TW (%) in Group H was significantly greater than that of Group L (P < 0.001). No significant differences were detected between the two groups with regard to any of the clinical outcomes evaluated. High levels of initial graft tension resulted in greater TW of the femoral tunnel aperture following anatomical ACL reconstruction using BPTB grafts. However, such levels of graft tension did not affect clinical outcome.

Region of interest processing for iterative reconstruction in x-ray computed tomography

NASA Astrophysics Data System (ADS)

Kopp, Felix K.; Nasirudin, Radin A.; Mei, Kai; Fehringer, Andreas; Pfeiffer, Franz; Rummeny, Ernst J.; Noël, Peter B.

2015-03-01

The recent advancements in the graphics card technology raised the performance of parallel computing and contributed to the introduction of iterative reconstruction methods for x-ray computed tomography in clinical CT scanners. Iterative maximum likelihood (ML) based reconstruction methods are known to reduce image noise and to improve the diagnostic quality of low-dose CT. However, iterative reconstruction of a region of interest (ROI), especially ML based, is challenging. But for some clinical procedures, like cardiac CT, only a ROI is needed for diagnostics. A high-resolution reconstruction of the full field of view (FOV) consumes unnecessary computation effort that results in a slower reconstruction than clinically acceptable. In this work, we present an extension and evaluation of an existing ROI processing algorithm. Especially improvements for the equalization between regions inside and outside of a ROI are proposed. The evaluation was done on data collected from a clinical CT scanner. The performance of the different algorithms is qualitatively and quantitatively assessed. Our solution to the ROI problem provides an increase in signal-to-noise ratio and leads to visually less noise in the final reconstruction. The reconstruction speed of our technique was observed to be comparable with other previous proposed techniques. The development of ROI processing algorithms in combination with iterative reconstruction will provide higher diagnostic quality in the near future.

Cross-cultural medical education: can patient-centered cultural competency training be effective in non-Western countries?

PubMed

Ho, Ming-Jung; Yao, Grace; Lee, Keng-Lin; Beach, Mary Catherine; Green, Alexander R

2008-01-01

No evidence addresses the effectiveness of patient-centered cultural competence training in non-Western settings. To examine whether a patient-centered cultural competency curriculum improves medical students' skills in eliciting the patients' perspective and exploring illness-related social factors. Fifty-seven medical students in Taiwan were randomly assigned to either the control (n = 27) or one of two intervention groups: basic (n = 15) and extensive (n = 15). Both intervention groups received two 2-hour patient-centered cultural competency workshops. In addition, the extensive intervention group received a 2-hour practice session. The control group received no training. At the end of the clerkship, all students were evaluated with an objective structured clinical examination (OSCE). Students in the extensive intervention group scored significantly higher than the basic intervention and control groups in eliciting the patient's perspective (F = 18.38, p < 0.001, eta(2) = 0.40). Scores of both intervention groups were significantly higher than the control group in the exploring social factors (F = 6.66, p = 0.003, eta(2) = 0.20). Patient-centered cultural competency training can produce improvement in medical students' cross-cultural communication skills in non-Western settings, especially when adequate practice is provided.

[Evidence-based Chinese medicine：theory and practice].

PubMed

Zhang, Jun-Hua; Li, You-Ping; Zhang, Bo-Li

2018-01-01

The introduction and popularization of evidence-based medicine has opened up a new research field of clinical efficacy evaluation of traditional Chinese medicine(TCM), produced new research ideas and methods, and promoted the progress of clinical research of TCM. After about 20 years assiduous study and earnest practice, the evidence based evaluation method and technique, which conforms to the characteristics of TCM theory and practice, has been developing continuously. Evidence-based Chinese medicine (EBCM) has gradually formed and become an important branch of evidence-based medicine. The basic concept of evidence-based Chinese medicine: EBCM is an applied discipline, following the theory and methodology of evidence-based medicine, to collect, evaluate, produce, transform the evidence of effectiveness, safety and economy of TCM, to reveal the feature and regular pattern of TCM taking effect, and to guide the development of clinical guidelines, clinical pathways and health decisions. The effects and achievements of EBCM development: secondary studies mainly based on systematic review/Meta-analysis were extensively carried out; clinical efficacy studies mainly relying on randomized controlled trials grew rapidly; clinical safety evaluations based on real world study have been conducted; methodological researches mainly focused on study quality control deepened gradually; internationalization researches mainly on report specifications have got some breakthroughs; standardization researches based on treatment specification were strengthened gradually; the research team and talents with the characteristics of inter-disciplinary have been steadily increased. A number of high-quality research findings have been published at international well-known journals; the clinical efficacy and safety evidence of TCM has been increased; the level of clinical rational use of TCM has been improved; a large number of Chinese patent medicines with big market have been cultured. The future missions of EBCM mainly consist of four categories (scientific research, methodology and standard, platform construction and personnel training) with nine tasks. ①Carry out systematic reviews to systematically collect clinical trial reports of TCM and establish database of clinical evidence of TCM; ②Carry out evidence transformation research to lay the foundation for the development of clinical diagnosis and treatment guidelines, clinical pathways of TCM, and for the screening of basic drug list and medical insurance list, and for the policy-making relevant to TCM; ③Conduct researches to evaluate the advantages and effective regular patterns of TCM and form the evidence chain of TCM efficacy; ④Carry out researches for the safety evaluation of TCM, and provide evidence supporting the rational and safe use of TCM in clinical practice; ⑤Conduct researches on methodology of EBCM and provide method for developing high quality evidence; ⑥Carry out researches to develop standards and norms of TCM, and to form methods, standards, specifications and technical systems; ⑦Establish data management platform for evidence-based evaluation of TCM, and promote data sharing; ⑧Build international academic exchange platform to promote international cooperation and mutual recognition of EBCM research; ⑨Carry out education and popularization activities of evidence-based evaluation methods, and train undergraduate students, graduate students, clinical healthcare providers and practitioners of TCM. The development of EBCM, as it was, not only promoted the transformation of clinical research and decision-making mode of TCM, contributed to the modernization and internationalization of TCM, but also enriched the connotation of Evidence-based Medicine. Copyright© by the Chinese Pharmaceutical Association.

Familial Prion Disease with Alzheimer Disease-Like Tau Pathology and Clinical Phenotype

PubMed Central

Jayadev, Suman; Nochlin, David; Poorkaj, Parvoneh; Steinbart, Ellen J.; Mastrianni, James A.; Montine, Thomas J.; Ghetti, Bernardino; Schellenberg, Gerard D.; Bird, Thomas D.; Leverenz, James B.

2011-01-01

Objective To describe the Alzheimer disease (AD)-like clinical and pathological features, including marked neurofibrillary tangle (NFT) pathology, of a familial prion disease due to a rare nonsense mutation of the prion gene (PRNP). Methods Longitudinal clinical assessments were available for the proband and her mother. After death, both underwent neuropathological evaluation. PRNP was sequenced after failure to find immunopositive Aβ deposits in the proband and the documentation of prion protein (PrP) immunopositive pathology. Results The proband presented at age 42 years with a 3-year history of progressive short-term memory impairment and depression. Neuropsychological testing found impaired memory performance, with relatively preserved attention and construction. She was diagnosed with AD and died at age 47 years. Neuropathologic evaluation revealed extensive limbic and neocortical NFT formation and neuritic plaques consistent with a Braak stage of VI. The NFTs were immunopositive, with multiple tau antibodies, and electron microscopy revealed paired helical filaments. However, the neuritic plaques were immunonegative for Aβ, whereas immunostaining for PrP was positive. The mother of the proband had a similar presentation, including depression, and had been diagnosed clinically and pathologically as AD. Reevaluation of her brain tissue confirmed similar tau and PrP immunostaining findings. Genetic analysis revealed that both the proband and her mother had a rare PRNP mutation (Q160X) that resulted in the production of truncated PrP. Interpretation We suggest that PRNP mutations that result in a truncation of PrP lead to a prolonged clinical course consistent with a clinical diagnosis of AD and severe AD-like NFTs. PMID:21416485

Tools for structured team communication in pre-registration health professions education: a Best Evidence Medical Education (BEME) review: BEME Guide No. 41.

PubMed

Buckley, Sharon; Ambrose, Lucy; Anderson, Elizabeth; Coleman, Jamie J; Hensman, Marianne; Hirsch, Christine; Hodson, James; Morley, David; Pittaway, Sarah; Stewart, Jonathan

2016-10-01

Calls for the inclusion of standardized protocols for information exchange into pre-registration health professions curricula have accompanied their introduction into clinical practice. In order to help clinical educators respond to these calls, we have reviewed educational interventions for pre-registration students that incorporate one or more of these ?tools for structured communication?. Searches of 10 databases (1990?2014) were supplemented by hand searches and by citation searches (to January 2015). Studies evaluating an intervention for pre-registration students of any clinical profession and incorporating at least one tool were included. Quality of included studies was assessed using a checklist of 11 indicators and a narrative synthesis of findings undertaken. Fifty studies met our inclusion criteria. Of these, 21 evaluated the specific effect of a tool on educational outcomes, and 27 met seven or more quality indicators. Pre-registration students, particularly those in the US, are learning to use tools for structured communication either in specific sessions or integrated into more extensive courses or programmes; mostly 'Situation Background Assessment Recommendation' and its variants. There is some evidence that learning to use a tool can improve the clarity and comprehensiveness of student communication, their perceived self-confidence and their sense of preparedness for clinical practice. There is, as yet, little evidence for the transfer of these skills to the clinical setting or for any influence of teaching approach on learning outcomes. Educators will need to consider the positioning of such learning with other skills such as clinical reasoning and decision-making.

The Mediolateral Excursion of the Meniscal Bearing during Flexion and Extension of the Knee after Medial Mobile-Bearing Unicompartmental Knee Arthroplasty.

PubMed

Lee, Seung-Yup; Bae, Ji-Hoon; Suh, Dong-Won; Kim, Han-Ju; Lim, Hong-Chul

2017-02-01

This mediolateral excursion of the bearing during knee motion is supposed to be caused by external rotation of the tibia during knee extension. However, to our knowledge, there is no published clinical evidence supporting these hypotheses. The current study aimed to evaluate the mediolateral excursion of the bearing during flexion-extension motion of the knee after medial unicompartmental knee arthroplasty (UKA). In 52 knees, varus/valgus (F-VarVal) or rotational position (F-Rot) of the femoral component and relative location of the bearing were measured with the standing anteroposterior and modified axial view, respectively. We adopted the modified axial radiographs that are simple to assess the bearing position in the flexed knee. The modified axial view showed excellent inter- and intraobserver agreements. F-Rot in the modified axial view and CT showed a high agreement in terms of validity (r = 0.98; p  < 0.0001). On average, the bearing showed more medial position in extension than flexion of the knee. No correlation was found between the femoral component positions (F-VarVal and F-Rot) and mediolateral bearing excursion ( p  = 0.68 and 0.80, respectively). In conclusion, coronal location of bearing according to flexion-extension of the knee is not influenced by the coronal and axial alignment of the femoral component. With simple radiographic method, more medial position of the bearing according to flexion-extension of the knee. Our method could be used to assess axial rotation of the femoral component and spin-out phenomenon of the bearing following the medial UKA. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Using Maps in Web Analytics to Evaluate the Impact of Web-Based Extension Programs

ERIC Educational Resources Information Center

Veregin, Howard

2015-01-01

Maps can be a valuable addition to the Web analytics toolbox for Extension programs that use the Web to disseminate information. Extension professionals use Web analytics tools to evaluate program impacts. Maps add a unique perspective through visualization and analysis of geographic patterns and their relationships to other variables. Maps can…

Cost Effectiveness Ratio: Evaluation Tool for Comparing the Effectiveness of Similar Extension Programs

ERIC Educational Resources Information Center

Jayaratne, K. S. U.

2015-01-01

Extension educators have been challenged to be cost effective in their educational programming. The cost effectiveness ratio is a versatile evaluation indicator for Extension educators to compare the cost of achieving a unit of outcomes or educating a client in similar educational programs. This article describes the cost effectiveness ratio and…

Proceedings of the Annual Conference of the Association for International Agricultural and Extension Education (15th, Port of Spain, Trinidad and Tobago March 21-26, 1999).

ERIC Educational Resources Information Center

Richardson, John G., Ed.

This proceedings contains session topics: extension systems, extension programs, extension evaluation, program impacts, extension management, extension reform, experiential learning, program delivery, farming systems research, professional training and development, program strategies, teaching effectiveness, organizational leadership, extension…

A web-based rapid prototyping and clinical conversational system that complements electronic patient record system.

PubMed

Kim, J H; Ferziger, R; Kawaloff, H B; Sands, D Z; Safran, C; Slack, W V

2001-01-01

Even the most extensive hospital information system cannot support all the complex and ever-changing demands associated with a clinical database, such as providing department or personal data forms, and rating scales. Well-designed clinical dialogue programs may facilitate direct interaction of patients with their medical records. Incorporation of extensive and loosely structured clinical data into an existing medical record system is an essential step towards a comprehensive clinical information system, and can best be achieved when the practitioner and the patient directly enter the contents. We have developed a rapid prototyping and clinical conversational system that complements the electronic medical record system, with its generic data structure and standard communication interfaces based on Web technology. We believe our approach can enhance collaboration between consumer-oriented and provider-oriented information systems.

Mechanical design of a distal arm exoskeleton for stroke and spinal cord injury rehabilitation.

PubMed

Pehlivan, Ali Utku; Celik, Ozkan; O'Malley, Marcia K

2011-01-01

Robotic rehabilitation has gained significant traction in recent years, due to the clinical demonstration of its efficacy in restoring function for upper extremity movements and locomotor skills, demonstrated primarily in stroke populations. In this paper, we present the design of MAHI Exo II, a robotic exoskeleton for the rehabilitation of upper extremity after stroke, spinal cord injury, or other brain injuries. The five degree-of-freedom robot enables elbow flexion-extension, forearm pronation-supination, wrist flexion-extension, and radial-ulnar deviation. The device offers several significant design improvements compared to its predecessor, MAHI Exo I. Specifically, issues with backlash and singularities in the wrist mechanism have been resolved, torque output has been increased in the forearm and elbow joints, a passive degree of freedom has been added to allow shoulder abduction thereby improving alignment especially for users who are wheelchair-bound, and the hardware now enables simplified and fast swapping of treatment side. These modifications are discussed in the paper, and results for the range of motion and maximum torque output capabilities of the new design and its predecessor are presented. The efficacy of the MAHI Exo II will soon be validated in a series of clinical evaluations with both stroke and spinal cord injury patients. © 2011 IEEE

Manual resurfacing and trichloroacetic acid for the treatment of patients with widespread actinic damage. Clinical and histologic observations.

PubMed

Cooley, J E; Casey, D L; Kauffman, C L

1997-05-01

A facial resurfacing regimen combining manual abrasion of the skin and 25% trichloroacetic acid has been reported to produce excellent results, but the histologic depth of injury produced by this technique has not been studied. To describe our experience with this technique treating patients with extensive actinic damage and to determine the histologic depth of injury produced. We treated 40 patients using manual resurfacing and trichloroacetic acid, primarily for widespread actinic keratoses. Resurfacing tools included silicone carbide sandpaper, drywall screen, electrocautery tip cleaners, abrasive pads, scalpel blades, and curettes. Four patients underwent sequential biopsies to evaluate the depth of wounding using this technique. Manual resurfacing combined with trichloroacetic acid consistently produced excellent cosmetic results and nearly complete eradication of actinic keratoses. Histologically, treated areas showed replacement of the dermal elastotic band by newly formed collagen, a significantly deeper level of wounding than the Jessner's/35% trichloroacetic acid peel. There was no evidence for foreign body granulomas clinically or histologically as a result of the abrasive materials. The deeper level of this peel explains the improved cosmetic outcome and greater eradication of actinic keratoses. This treatment is particularly well suited for patients with extensive photodamage and widespread actinic keratoses.

Extensive tissue damage of bovine ovaries after bipolar ovarian drilling compared to monopolar electrocoagulation or carbon dioxide laser.

PubMed

Hendriks, Marja-Liisa; van der Valk, Paul; Lambalk, Cornelis B; Broeckaert, Mark A M; Homburg, Roy; Hompes, Peter G A

2010-02-01

To evaluate the size of ovarian damage caused by ovarian drilling in polycystic ovary syndrome, the amount of inflicted damage was assessed for the most frequently used ovarian drilling techniques. Experimental prospective design. University clinic. Six fresh bovine ovaries per technique. Carbon dioxide (CO(2)) laser, monopolar electrocoagulation, and bipolar electrocoagulation were used for in vitro ovarian drilling. Amount of inflicted ovarian damage per procedure. Bipolar electrocoagulation resulted in significantly more destruction per burn than the CO(2) laser and monopolar electrocoagulation (287.6 versus 24.0 and 70.0 mm(3), respectively). The damage found per lesion was multiplied by the regularly applied number of punctures per procedure in daily practice (based on the literature). Again, the bipolar electrocoagulation resulted in significantly more tissue damage than the CO(2) laser and monopolar coagulation (2,876 versus 599 and 700 mm(3), respectively). Ovarian drilling, especially bipolar electrocoagulation, causes extensive destruction of the ovary. Given the same clinical effectiveness of the various procedures, it is essential to use the lowest possible dose that works; thus, the first choice should be CO(2) laser or monopolar electrocoagulation. Copyright 2010 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

Clinical case definition for the diagnosis of acute intussusception.

PubMed

Bines, Julie E; Ivanoff, Bernard; Justice, Frances; Mulholland, Kim

2004-11-01

Because of the reported association between intussusception and a rotavirus vaccine, future clinical trials of rotavirus vaccines will need to include intussusception surveillance in the evaluation of vaccine safety. The aim of this study is to develop and validate a clinical case definition for the diagnosis of acute intussusception. A clinical case definition for the diagnosis of acute intussusception was developed by analysis of an extensive literature review that defined the clinical presentation of intussusception in 70 developed and developing countries. The clinical case definition was then assessed for sensitivity and specificity using a retrospective chart review of hospital admissions. Sensitivity of the clinical case definition was assessed in children diagnosed with intussusception over a 6.5-year period. Specificity was assessed in patients aged <2 years admitted with bowel obstruction and in patients aged <19 years presenting with symptoms that may occur in intussusception. The clinical case definition accurately identified 185 of 191 assessable cases as "probable" intussusception and six cases as "possible" intussusception (sensitivity, 97%). No case of radiologic or surgically proven intussusception failed to be identified by the clinical case definition. The specificity of the definition in correctly identifying patients who did not have intussusception ranged from 87% to 91%. The clinical case definition for intussusception may assist in the prompt identification of patients with intussusception and may provide an important tool for the future trials of enteric vaccines.

Mold prevention strategies and possible health effects in the aftermath of hurricanes and major floods.

PubMed

Brandt, Mary; Brown, Clive; Burkhart, Joe; Burton, Nancy; Cox-Ganser, Jean; Damon, Scott; Falk, Henry; Fridkin, Scott; Garbe, Paul; McGeehin, Mike; Morgan, Juliette; Page, Elena; Rao, Carol; Redd, Stephen; Sinks, Tom; Trout, Douglas; Wallingford, Kenneth; Warnock, David; Weissman, David

2006-06-09

Extensive water damage after major hurricanes and floods increases the likelihood of mold contamination in buildings. This report provides information on how to limit exposure to mold and how to identify and prevent mold-related health effects. Where uncertainties in scientific knowledge exist, practical applications designed to be protective of a person's health are presented. Evidence is included about assessing exposure, clean-up and prevention, personal protective equipment, health effects, and public health strategies and recommendations. The recommendations assume that, in the aftermath of major hurricanes or floods, buildings wet for <48 hours will generally support visible and extensive mold growth and should be remediated, and excessive exposure to mold-contaminated materials can cause adverse health effects in susceptible persons regardless of the type of mold or the extent of contamination. For the majority of persons, undisturbed mold is not a substantial health hazard. Mold is a greater hazard for persons with conditions such as impaired host defenses or mold allergies. To prevent exposure that could result in adverse health effects from disturbed mold, persons should 1) avoid areas where mold contamination is obvious; 2) use environmental controls; 3) use personal protective equipment; and 4) keep hands, skin, and clothing clean and free from mold-contaminated dust. Clinical evaluation of suspected mold-related illness should follow conventional clinical guidelines. In addition, in the aftermath of extensive flooding, health-care providers should be watchful for unusual mold-related diseases. The development of a public health surveillance strategy among persons repopulating areas after extensive flooding is recommended to assess potential health effects and the effectiveness of prevention efforts. Such a surveillance program will help CDC and state and local public health officials refine the guidelines for exposure avoidance, personal protection, and clean-up and assist health departments to identify unrecognized hazards.

[Designs and thoughts of real world integrated data warehouse from HIS on re-evaluation of post-maketing traditional Chinese medicine].

PubMed

Zhuang, Yan; Xie, Bangtie; Weng, Shengxin; Xie, Yanming

2011-10-01

To discuss the feasibility and necessity of using HIS data integration to build large data warehouse system which is extensively used on re-evaluation of post-marketing traditional Chinese medicine, and to provide the thought and method of the overall design for it. With domestic and overseas' analysis and comparison on clinical experiments' design based on real world using electronic information system, and with characteristics of HIS in China, a general framework was designed and discussed which refers to design thought, design characteristics, existing problems and solutions and so on. A design scheme of HIS data warehouse on re-evaluation of post-marketing traditional Chinese medicine was presented. The design scheme was proved to be high coherence and low coupling, safe, Universal, efficient and easy to maintain, which can effectively solve the problems many hospitals have faced during the process of HIS data integration.

A finite element evaluation of mechanical function for 3 distal extension partial dental prosthesis designs with a 3-dimensional nonlinear method for modeling soft tissue.

PubMed

Nakamura, Yoshinori; Kanbara, Ryo; Ochiai, Kent T; Tanaka, Yoshinobu

2014-10-01

The mechanical evaluation of the function of partial removable dental prostheses with 3-dimensional finite element modeling requires the accurate assessment and incorporation of soft tissue behavior. The differential behaviors of the residual ridge mucosa and periodontal ligament tissues have been shown to exhibit nonlinear displacement. The mathematic incorporation of known values simulating nonlinear soft tissue behavior has not been investigated previously via 3-dimensional finite element modeling evaluation to demonstrate the effect of prosthesis design on the supporting tissues. The purpose of this comparative study was to evaluate the functional differences of 3 different partial removable dental prosthesis designs with 3-dimensional finite element analysis modeling and a simulated patient model incorporating known viscoelastic, nonlinear soft tissue properties. Three different designs of distal extension removable partial dental prostheses were analyzed. The stress distributions to the supporting abutments and soft tissue displacements of the designs tested were calculated and mechanically compared. Among the 3 dental designs evaluated, the RPI prosthesis demonstrated the lowest stress concentrations on the tissue supporting the tooth abutment and also provided wide mucosa-borne areas of support, thereby demonstrating a mechanical advantage and efficacy over the other designs evaluated. The data and results obtained from this study confirmed that the functional behavior of partial dental prostheses with supporting abutments and soft tissues are consistent with the conventional theories of design and clinical experience. The validity and usefulness of this testing method for future applications and testing protocols are shown. Copyright © 2014 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

Device-identified atrial fibrillation at pacing clinics. Should it guide anticoagulation?

PubMed

Merinopoulos, Ioannis; Raphael, Claire E; Yardley, Alaina; Goonewardene, Manoj; Vassiliou, Vassilios S

2016-03-15

In recent years, there has been a significant increase in the number of devices implanted following improvement in their safety profile, extension of indications and reduction in cost. Although the reason remains largely the beneficial effect on heart rhythm stabilisation, implanted devices might also have additional advantages, notably identification of silent arrhythmia. Should clinicians therefore act on device-identified atrial fibrillation (AF) and should such identification be used to guide anticoagulation management? This review evaluates the current evidence on the management of device-identified asymptomatic AF. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

[Orbital extension of sinus plasmacytoma secondarily transforming into multiple myeloma: a case study].

PubMed

Balayre, S; Gicquel, J-J; Mercie, M; Dighiero, P

2004-01-01

We report the case of a 39-year-old man who consulted for severe exophthalmia with diplopia associated with chronic sinusitis evolving over 6 months. A cervicofacial CT scan showed a tumoral mass invading the maxillary and ethmoidal left sinus and orbital cavity. A biopsy of the mass and general evaluation confirmed the diagnosis of extramedullary plasmocytoma. Secondarily it transformed into multiple myeloma. In light of this case of extramedullary plasmocytoma in a young subject, we discuss the clinical characteristics, ophthalmologic manifestations, and the various therapeutic modalities according to the stage of the disease and the ocular repercussions.

Expanding Access to HCV Treatment - Extension for Community Healthcare Outcomes (ECHO) Project: Disruptive Innovation in Specialty Care

PubMed Central

Arora, Sanjeev; Kalishman, Summers; Thornton, Karla; Dion, Denise; Murata, Glen; Deming, Paulina; Parish, Brooke; Brown, John; Komaromy, Miriam; Colleran, Kathleen; Bankhurst, Arthur; Katzman, Joanna; Harkins, Michelle; Curet, Luis; Cosgrove, Ellen; Pak, Wesley

2013-01-01

The Extension for Community Healthcare Outcomes (ECHO) Model was developed by the University of New Mexico Health Sciences Center (UNMHSC) as a platform to deliver complex specialty medical care to underserved populations through an innovative educational model of team-based inter-disciplinary development. Using state-of-the-art telehealth technology, best practice protocols, and case based learning, ECHO trains and supports primary care providers to develop knowledge and self-efficacy on a variety of diseases. As a result, they can deliver best practice care for complex health conditions in communities where specialty care is unavailable. ECHO was first developed for the management of hepatitis C virus (HCV), optimal management of which requires consultation with multi-disciplinary experts in medical specialties, mental health and substance abuse. Few practitioners, particularly in rural and underserved areas, have the knowledge to manage its emerging treatment options, side effects, drug toxicities and treatment-induced depression. In addition data was obtained from observation of ECHO weekly clinics and database of ECHO clinic participation and patient presentations by clinical provider, evaluation of the ECHO program incorporates annual survey integrated into the ECHO annual meeting and routine surveys of community providers about workplace learning, personal and professional experiences, systems and environmental factors associated with professional practice, self-efficacy, facilitators and barriers to ECHO. The initial survey data show a significant improvement in provider knowledge, self-efficacy and professional satisfaction through participation in ECHO HCV clinics. Clinicians reported a moderate to major benefit from participation. We conclude that ECHO expands access to best practice care for underserved populations, builds communities of practice to enhance professional development and satisfaction of primary care clinicians, and expands sustainable capacity for care by building local centers of excellence. PMID:20607688

Durability of Therapeutic Response With Long-Term Aripiprazole Lauroxil Treatment Following Successful Resolution of an Acute Episode of Schizophrenia.

PubMed

McEvoy, Joseph P; Risinger, Robert; Mykhnyak, Serhiy; Du, Yangchun; Liu, Chih-Chin; Stanford, Arielle D; Weiden, Peter J

To evaluate durability of therapeutic effect of long-term treatment with aripiprazole lauroxil in patients with schizophrenia following successful treatment of an acute psychotic episode. This post hoc analysis assessed long-term outcomes for a subgroup of patients who entered a 52-week extension study after being successfully stabilized with one of 2 doses of aripiprazole lauroxil (441 or 882 mg) in a pivotal 12-week, placebo-controlled, randomized clinical trial. Durability of therapeutic effect was measured by the proportion of patients completing the 1-year course of aripiprazole lauroxil, the trajectories of the Positive and Negative Syndrome Scale (PANSS) total and the Clinical Global Impression-Severity (CGI-S) item scores beyond the first 12 weeks, and the likelihood of remission at any follow-up point. In total, 181 patients treated with aripiprazole lauroxil entered the extension study; 73% and 66% of patients from the 441 mg and 882 mg groups, respectively, completed all 13 aripiprazole lauroxil treatments scheduled every 4 weeks over 52 weeks. Both groups continued on a positive trajectory of symptom improvements (P < .0001 for reductions in PANSS total and CGI-S scores from week 12 to end of follow-up). Most patients (74% and 68% in the aripiprazole lauroxil 441 mg and 882 mg groups, respectively) achieved remission during follow-up. These post hoc analyses of a subgroup of patients demonstrate the continued therapeutic efficacy of aripiprazole lauroxil after successful treatment of an acute episode of schizophrenia. Both the 441 mg and 882 mg groups had similar retention rates, degree of symptom improvement, and likelihood of remission. ClinicalTrials.gov identifier: NCT01469039; European Clinical Trials Database (EudraCT) numbers: 2012-003445-15 and 2012-003996-20​​​​. © Copyright 2017 Physicians Postgraduate Press, Inc.

Revised STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement

PubMed Central

MacPherson, Hugh; Altman, Douglas G; Hammerschlag, Richard; Li, Youping; Wu, Taixiang; White, Adrian; Moher, David

2010-01-01

The STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) were published in five journals in 2001 and 2002. These guidelines, in the form of a checklist and explanations for use by authors and journal editors, were designed to improve reporting of acupuncture trials, particularly the interventions, thereby facilitating their interpretation and replication. Subsequent reviews of the application and impact of STRICTA have highlighted the value of STRICTA as well as scope for improvements and revision. To manage the revision process a collaboration between the STRICTA Group, the CONSORT Group and the Chinese Cochrane Centre was developed in 2008. An expert panel with 47 participants was convened that provided electronic feedback on a revised draft of the checklist. At a subsequent face-to-face meeting in Freiburg, a group of 21 participants further revised the STRICTA checklist and planned dissemination. The new STRICTA checklist, which is an official extension of CONSORT, includes 6 items and 17 subitems. These set out reporting guidelines for the acupuncture rationale, the details of needling, the treatment regimen, other components of treatment, the practitioner background and the control or comparator interventions. In addition, and as part of this revision process, the explanations for each item have been elaborated, and examples of good reporting for each item are provided. In addition, the word ‘controlled’ in STRICTA is replaced by ‘clinical’, to indicate that STRICTA is applicable to a broad range of clinical evaluation designs, including uncontrolled outcome studies and case reports. It is intended that the revised STRICTA checklist, in conjunction with both the main CONSORT statement and extension for non-pharmacological treatment, will raise the quality of reporting of clinical trials of acupuncture. PMID:20615861

A qualitative examination of women's self-presentation and social physique anxiety during injury rehabilitation.

PubMed

Driediger, Molly V; McKay, Carly D; Hall, Craig R; Echlin, Paul S

2016-12-01

To understand women's self-presentation experiences in the rehabilitation setting, and their attitudes and preferences toward the social and physical features of the rehabilitation environment. Qualitative study. Outpatient physiotherapy clinic. Ten women (age 18 to 64) with high social physique anxiety (Social Physique Anxiety Scale score ≥25) referred for physiotherapy following acute injury. Semi-structured interviews were conducted prior to commencement of treatment, and again after a third treatment session. Participants experienced extensive self-presentational concerns that were intensified due to the nature of the physiotherapy environment. The women reported that their self-presentational anxiety did not diminish over time, and was related to others' negative perceptions regarding their physical appearance and inability to perform exercises as well as expected. The presence of men or younger women in the clinic was identified as a barrier to appointment attendance, along with open concept clinic settings, which were associated with the most potential for evaluation. Mirrors and windows in the physiotherapy clinic were highlighted as anxiety provoking. The women suggested that they would feel apprehensive about advocating for themselves if they felt uncomfortable with the area in which they were receiving treatment, and instead used avoidance coping strategies (e.g., hiding behind equipment, preventing eye contact) to manage their anxiety. Physique-anxious women experience extensive self-presentational concerns in the rehabilitation environment, which could affect treatment adherence. Modifying the treatment setting, providing protective self-presentational strategies such as positive self-talk, and open patient-therapist communication could be implemented to help mitigate these concerns. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Improved glycemic control in veterans with poorly controlled diabetes mellitus using a Specialty Care Access Network-Extension for Community Healthcare Outcomes model at primary care clinics.

PubMed

Watts, Sharon A; Roush, Laura; Julius, Mary; Sood, Ajay

2016-06-01

An increasing number of patients with diabetes mellitus has created a need for innovative delivery of specialized care not only by diabetes specialists but also by primary care providers (PCPs) as well. A potential avenue to address this need is training of PCPs by specialists via telehealth. The Veteran Affairs (VA) Specialty Care Access Network-Extension for Community Healthcare Outcomes (SCAN-ECHO) program includes education and case-based learning for PCPs by a multidisciplinary specialty team utilizing videoconferencing technology. Two PCPs completed a year of SCAN-ECHO diabetes training. These two PCPs set up "diabetes mini-clinics" to treat difficult-to-control high-risk patients with diabetes mellitus from their own panel and from their colleagues in the same community-based outpatient clinic (CBOC). We utilized a retrospective program evaluation by t-test using pre/post glycated hemoglobin (HbA1c) lab values after being seen by the two PCPs. A total of 39 patients, all with HbA1c > 9.0%, were seen in the two PCP mini-clinics over 15 months. The mean HbA1c improved from 10.2 ± 1.4% to 8.4 ± 1.8% (p < 0.001) over the average follow-up period of five months. This was not explained by system-wide changes or improvements. Care of veteran patients with poorly controlled diabetes by PCPs who participated in SCAN-ECHO program leads to improvement in glycemic control. This model of health care delivery can be effective in remote or rural areas with limited availability of specialists. © The Author(s) 2015.

Differences between clinical "snap-shot" and "real-life" assessments of lumbar spine alignment and motion - What is the "real" lumbar lordosis of a human being?

PubMed

Dreischarf, Marcel; Pries, Esther; Bashkuev, Maxim; Putzier, Michael; Schmidt, Hendrik

2016-03-21

The individual lumbar lordosis and lumbar motion have been identified to play an important role in pathogenesis of low back pain and are essential references for preoperative planning and postoperative evaluation. The clinical "gold-standard" for measuring lumbar lordosis and its motion are radiological "snap-shots" taken while standing and during upper-body flexion and extension. The extent to which these clinically assessed values characterise lumbar alignment and its motion in daily life merits discussion. A non-invasive measurement-system was employed to measure lumbar lordosis and lumbar motion in 208 volunteers (age: 20-74yrs; ♀/♂: 115/93). For an initial short-term measurement, comparable with the clinical "snap-shot", lumbar lordosis and its motion were assessed while standing and during flexion and extension. Subsequently, volunteers were released to their daily lives while wearing the device, and measurements were performed during the following 24h. The average lumbar lordosis during 24h (8.0°) differed significantly from the standardised measurement while standing (33.3°). Ranges of motion were significantly different throughout the day compared to standing measurements. The influence of the factors age and gender on lordosis and its motion resulted in conflicting results between long- and short-term-measurements. In conclusion, results of short-term examinations differ considerably from the average values during real-life. These findings might be important for surgical planning and increase the awareness of the biomechanical challenges that spinal structures and implants face in real-life. Furthermore, long-term assessments of spinal alignment and motion during daily life can provide valid data on spinal function and can reveal the importance of influential factors. Copyright © 2016 Elsevier Ltd. All rights reserved.

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.

[Integrated Peer Teaching of Communication and Clinical Skills: How to Train Student Tutors?].

PubMed

Ringel, Nadja; Bürmann, Barbara Maatouk; Fellmer-Drueg, Erika; Roos, Marco; Herzog, Wolfgang; Nikendei, Christoph; Wischmann, Tewes; Weiss, Carmen; Eicher, Christiane; Engeser, Peter; Schultz, Jobst-Hendrik; Jünger, Jana

2015-08-01

This paper describes the theory-based development of a standardized training model for peer tutors. The aim is to qualify tutors to teach communication skills integrated with practical clinical skills, to medical students in the pre-clinical curriculum. As a result, students are encouraged to form a basic understanding of the biopsychosocial model of diseases early in their studies. The training model's design is based on the Kern model for curriculum development as adapted by McLean et al., who outlined the following steps: planning, implementation, and evaluation/feedback. Our focus is on development, review of feasibility, and evaluation as measured by the subjectively perceived effectiveness of the implemented training model. 2 target groups were considered: the peer tutors and the student tutees. In 2009, a 3-step training model consisting of 12 units was developed, based on the theory of patient-centered communication and the biopsychosocial model. The training was rated very positively on a 5-point Likert scale by all tutors at 2 points in time: t1 (directly after training) and t2 (after conducting 2 tutorials) (t1: M=1.67; SD=±0.86; t2: M=1.75; SD=±0.71). On a 6-point Likert scale, the tutees also evaluated their communication and clinical skills as being significantly better after completing the 10 tutorials (t2: scale for interaction and communication: M=4.81; SD: 1.09; scale for clinical examination: M=4.99; SD: 0.85) than before the tutorials (t0: scale for communication and interaction: M=3.18; SD=1.15; scale for clinical examination: M=2.88; SD: 1.09). By implementing a standardized tutor training model, one can qualify peer tutors to teach communication skills integrated with practical clinical skills during the pre-clinical phase. Practice teaching of the curricular material via role playing, tutorial simulation and an extensive feedback session, along with the definition of clinical standards for recording case histories and performing examinations, have proven themselves to be core elements of effective tutor training. © Georg Thieme Verlag KG Stuttgart · New York.

Matrix-Applied Characterized Autologous Cultured Chondrocytes Versus Microfracture: Five-Year Follow-up of a Prospective Randomized Trial.

PubMed

Brittberg, Mats; Recker, David; Ilgenfritz, John; Saris, Daniel B F

2018-05-01

Matrix-based cell therapy improves surgical handling, increases patient comfort, and allows for expanded indications with better reliability within the knee joint. Five-year efficacy and safety of autologous cultured chondrocytes on porcine collagen membrane (MACI) versus microfracture for treating cartilage defects have not yet been reported from any randomized controlled clinical trial. To examine the clinical efficacy and safety results at 5 years after treatment with MACI and compare these with the efficacy and safety of microfracture treatment for symptomatic cartilage defects of the knee. Randomized controlled trial; Level of evidence, 1. This article describes the 5-year follow-up of the SUMMIT (Superiority of MACI Implant Versus Microfracture Treatment) clinical trial conducted at 14 study sites in Europe. All 144 patients who participated in SUMMIT were eligible to enroll; analyses of the 5-year data were performed with data from patients who signed informed consent and continued in the Extension study. Of the 144 patients randomized in the SUMMIT trial, 128 signed informed consent and continued observation in the Extension study: 65 MACI (90.3%) and 63 microfracture (87.5%). The improvements in Knee injury and Osteoarthritis Outcome Score (KOOS) Pain and Function domains previously described were maintained over the 5-year follow-up. Five years after treatment, the improvement in MACI over microfracture in the co-primary endpoint of KOOS pain and function was maintained and was clinically and statistically significant ( P = .022). Improvements in activities of daily living remained statistically significantly better ( P = .007) in MACI patients, with quality of life and other symptoms remaining numerically higher in MACI patients but losing statistical significance relative to the results of the SUMMIT 2-year analysis. Magnetic resonance imaging (MRI) evaluation of structural repair was performed in 120 patients at year 5. As in the 2-year SUMMIT (MACI00206) results, the MRI evaluation showed improvement in defect filling for both treatments; however, no statistically significant differences were noted between treatment groups. Symptomatic cartilage knee defects 3 cm 2 or larger treated with MACI were clinically and statistically significantly improved at 5 years compared with microfracture treatment. No remarkable adverse events or safety issues were noted in this heterogeneous patient population.

Clinical utility of sperm DNA fragmentation testing: practice recommendations based on clinical scenarios

PubMed Central

Majzoub, Ahmad; Esteves, Sandro C.; Ko, Edmund; Ramasamy, Ranjith; Zini, Armand

2016-01-01

Sperm DNA fragmentation (SDF) has been generally acknowledged as a valuable tool for male fertility evaluation. While its detrimental implications on sperm function were extensively investigated, little is known about the actual indications for performing SDF analysis. This review delivers practice based recommendations on commonly encountered scenarios in the clinic. An illustrative description of the different SDF measurement techniques is presented. SDF testing is recommended in patients with clinical varicocele and borderline to normal semen parameters as it can better select varicocelectomy candidates. High SDF is also linked with recurrent spontaneous abortion (RSA) and can influence outcomes of different assisted reproductive techniques. Several studies have shown some benefit in using testicular sperm rather than ejaculated sperm in men with high SDF, oligozoospermia or recurrent in vitro fertilization (IVF) failure. Infertile men with evidence of exposure to pollutants can benefit from sperm DNA testing as it can help reinforce the importance of lifestyle modification (e.g., cessation of cigarette smoking, antioxidant therapy), predict fertility and monitor the patient’s response to intervention. PMID:28078226

The applications of regenerative medicine in sinus lift procedures: A systematic review.

PubMed

Correia, Francisco; Pozza, Daniel Humberto; Gouveia, Sónia; Felino, António; Faria E Almeida, Ricardo

2018-04-01

Findings in regenerative medicine applied to the sinus lift procedures. Evaluate the effectiveness of regenerative medicine in sinus lift. An extensive search for manuscripts were performed by using different combinations of keywords and MeSH terms (Pub-med; Embase; Scopus; Web of Science Core Collection; Medline; Current Contents Connect; Derwent Innovations Index; Scielo Citation Index; Cochrane library). The full text selected articles are written in English, Portuguese, Spanish, Italian, German, or French, and published until 28 of November 2016. Inclusion criteria were: implant osteointegration, radiographic, histologic, and/or histomorphometric analysis, clinical studies in humans using of regenerative medicine. This systematic review was performed by selecting only randomized controlled clinical trials and controlled clinical trials. Eighteen published studies (11 CT and 7 RCT) were considered eligible for inclusion in the present systematic review. These studies demonstrated considerable variation of biomaterial and cell technics used, study design, sinus lift technic, outcomes, follow-up, and results. Only few studies have demonstrated potential of regenerative medicine in sinus lift; further randomized clinical trials are needed to achieve more accurate results. © 2017 Wiley Periodicals, Inc.

Clinical reasoning in the real world is mediated by bounded rationality: implications for diagnostic clinical practice guidelines.

PubMed

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-04-20

Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. FOUR MAIN THEMES WERE IDENTIFIED: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration.

Clinical Reasoning in the Real World Is Mediated by Bounded Rationality: Implications for Diagnostic Clinical Practice Guidelines

PubMed Central

Bonilauri Ferreira, Ana Paula Ribeiro; Ferreira, Rodrigo Fernando; Rajgor, Dimple; Shah, Jatin; Menezes, Andrea; Pietrobon, Ricardo

2010-01-01

Background Little is known about the reasoning mechanisms used by physicians in decision-making and how this compares to diagnostic clinical practice guidelines. We explored the clinical reasoning process in a real life environment. Method This is a qualitative study evaluating transcriptions of sixteen physicians' reasoning during appointments with patients, clinical discussions between specialists, and personal interviews with physicians affiliated to a hospital in Brazil. Results Four main themes were identified: simple and robust heuristics, extensive use of social environment rationality, attempts to prove diagnostic and therapeutic hypothesis while refuting potential contradictions using positive test strategy, and reaching the saturation point. Physicians constantly attempted to prove their initial hypothesis while trying to refute any contradictions. While social environment rationality was the main factor in the determination of all steps of the clinical reasoning process, factors such as referral letters and number of contradictions associated with the initial hypothesis had influence on physicians' confidence and determination of the threshold to reach a final decision. Discussion Physicians rely on simple heuristics associated with environmental factors. This model allows for robustness, simplicity, and cognitive energy saving. Since this model does not fit into current diagnostic clinical practice guidelines, we make some propositions to help its integration. PMID:20421920

Definition of drug-resistant epilepsy: is it evidence based?

PubMed

Wiebe, Samuel

2013-05-01

Clinical case definitions are the cornerstone of clinical communication and of clinical and epidemiologic research. The ramifications of establishing a case definition are extensive, including potentially large changes in epidemiologic estimates of frequency, and decisions for clinical management. Yet, defining a condition entails numerous challenges such as defining the scope and purpose, incorporating the strongest evidence base with clinical expertise, accounting for patients' values, and considering impact on care. The clinical case definition of drug-resistant epilepsy, in addition, must address what constitutes an adequate intervention for an individual drug, what are the outcomes of relevance, what period of observation is sufficient to determine success or failure, how many medications should be tried, whether seizure frequency should play a role, and what is the role of side effects and tolerability. On the other hand, the principles of evidence-based medicine (EBM) aim at providing a systematic approach to incorporating the best available evidence into the process of clinical decision for individual patients. The case definition of drug-resistant epilepsy proposed by the the International League Against Epilepsy (ILAE) in 2009 is evaluated in terms of the principles of EBM as well as the stated goals of the authors of the definition. Wiley Periodicals, Inc. © 2013 International League Against Epilepsy.

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.

WE-F-BRB-00: New Developments in Knowledge-Based Treatment Planning and Automation

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

NONE

2015-06-15

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, itmore » is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.« less

WE-F-BRB-02: Setting the Stage for Incorporation of Toxicity Measures in Treatment Plan Assessments

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

Mayo, C.

2015-06-15

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, itmore » is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.« less

Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

PubMed

Vaduganathan, Muthiah; Nagarur, Amulya; Qamar, Arman; Patel, Ravi B; Navar, Ann Marie; Peterson, Eric D; Bhatt, Deepak L; Fonarow, Gregg C; Yancy, Clyde W; Butler, Javed

2018-02-27

Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement. Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication. © 2017 American Heart Association, Inc.

WE-F-BRB-03: Inclusion of Data-Driven Risk Predictions in Radiation Treatment Planning in the Context of a Local Level Learning Health System

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

McNutt, T.

Advancements in informatics in radiotherapy are opening up opportunities to improve our ability to assess treatment plans. Models on individualizing patient dose constraints from prior patient data and shape relationships have been extensively researched and are now making their way into commercial products. New developments in knowledge based treatment planning involve understanding the impact of the radiation dosimetry on the patient. Akin to radiobiology models that have driven intensity modulated radiotherapy optimization, toxicity and outcome predictions based on treatment plans and prior patient experiences may be the next step in knowledge based planning. In order to realize these predictions, itmore » is necessary to understand how the clinical information can be captured, structured and organized with ontologies and databases designed for recall. Large databases containing radiation dosimetry and outcomes present the opportunity to evaluate treatment plans against predictions of toxicity and disease response. Such evaluations can be based on dose volume histogram or even the full 3-dimensional dose distribution and its relation to the critical anatomy. This session will provide an understanding of ontologies and standard terminologies used to capture clinical knowledge into structured databases; How data can be organized and accessed to utilize the knowledge in planning; and examples of research and clinical efforts to incorporate that clinical knowledge into planning for improved care for our patients. Learning Objectives: Understand the role of standard terminologies, ontologies and data organization in oncology Understand methods to capture clinical toxicity and outcomes in a clinical setting Understand opportunities to learn from clinical data and its application to treatment planning Todd McNutt receives funding from Philips, Elekta and Toshiba for some of the work presented.« less

A Case of Hemiabdominal Myoclonus.

PubMed

Nociti, Viviana; Servidei, Serenella; Luigetti, Marco; Iorio, Raffaele; Lo Monaco, Mauro; Mirabella, Massimiliano; Frisullo, Giovanni; Della Marca, Giacomo

2015-10-01

Myoclonus consists of sudden, brief, involuntary jerky muscular contractions. Central and peripheral nervous system lesions are involved in the pathogenesis of this movement disorder. Symptomatic or secondary spinal myoclonus is the most common form. A 68-year-old woman was diagnosed with hemiabdominal spinal myoclonus. Occasional and very mild involuntary repetitive movements of the hemiabdomen began immediately after surgery for uterine cancer. After surgery for laparocele, secondary to the uterine cancer surgery, performed under spinal anesthesia, there was severe worsening of movements. Neuroradiological investigations failed to demonstrate spinal injury, while neurophysiological studies showed impairment of the right central somatosensory pathway. Considering the low resolution of magnetic resonance imaging in the evaluation of thoracic level, we suggest an extensive neurophysiological evaluation in patients with spinal myoclonus. © EEG and Clinical Neuroscience Society (ECNS) 2014.

Eliminating Tuberculosis One Neighborhood at a Time

PubMed Central

Griffith, David E.; McGaha, Paul K.; Wolfgang, Melanie; Robinson, Celia B.; Clark, Patricia A.; Hassell, Willis L.; Robison, Valerie A.; Walker, Kerfoot P.; Wallace, Charles

2014-01-01

Objectives. We evaluated a strategy for preventing tuberculosis (TB) in communities most affected by it. Methods. In 1996, we mapped reported TB cases (1985–1995) and positive tuberculin skin test (TST) reactors (1993–1995) in Smith County, Texas. We delineated the 2 largest, densest clusters, identifying 2 highest-incidence neighborhoods (180 square blocks, 3153 residents). After extensive community preparation, trained health care workers went door-to-door offering TST to all residents unless contraindicated. TST-positive individuals were escorted to a mobile clinic for radiography, clinical evaluation, and isoniazid preventive treatment (IPT) as indicated. To assess long-term impact, we mapped all TB cases in Smith County during the equivalent time period after the project. Results. Of 2258 eligible individuals, 1291 (57.1%) were tested, 229 (17.7%) were TST positive, and 147 were treated. From 1996 to 2006, there were no TB cases in either project neighborhood, in contrast with the preintervention decade and the continued occurrence of TB in the rest of Smith County. Conclusions. Targeting high-incidence neighborhoods for active, community-based screening and IPT may hasten TB elimination in the United States. PMID:24899457

Eliminating Tuberculosis One Neighborhood at a Time

PubMed Central

Griffith, David E.; McGaha, Paul K.; Wolfgang, Melanie; Robinson, Celia B.; Clark, Patricia A.; Hassell, Willis L.; Robison, Valerie A.; Walker, Kerfoot P.; Wallace, Charles

2013-01-01

Objectives. We evaluated a strategy for preventing tuberculosis (TB) in communities most affected by it. Methods. In 1996, we mapped reported TB cases (1985–1995) and positive tuberculin skin test (TST) reactors (1993–1995) in Smith County, Texas. We delineated the 2 largest, densest clusters, identifying 2 highest-incidence neighborhoods (180 square blocks, 3153 residents). After extensive community preparation, trained health care workers went door-to-door offering TST to all residents unless contraindicated. TST-positive individuals were escorted to a mobile clinic for radiography, clinical evaluation, and isoniazid preventive treatment (IPT) as indicated. To assess long-term impact, we mapped all TB cases in Smith County during the equivalent time period after the project. Results. Of 2258 eligible individuals, 1291 (57.1%) were tested, 229 (17.7%) were TST positive, and 147 were treated. From 1996 to 2006, there were no TB cases in either project neighborhood, in contrast with the preintervention decade and the continued occurrence of TB in the rest of Smith County. Conclusions. Targeting high-incidence neighborhoods for active, community-based screening and IPT may hasten TB elimination in the United States. PMID:23078465

Comparing and combining biomarkers as principle surrogates for time-to-event clinical endpoints.

PubMed

Gabriel, Erin E; Sachs, Michael C; Gilbert, Peter B

2015-02-10

Principal surrogate endpoints are useful as targets for phase I and II trials. In many recent trials, multiple post-randomization biomarkers are measured. However, few statistical methods exist for comparison of or combination of biomarkers as principal surrogates, and none of these methods to our knowledge utilize time-to-event clinical endpoint information. We propose a Weibull model extension of the semi-parametric estimated maximum likelihood method that allows for the inclusion of multiple biomarkers in the same risk model as multivariate candidate principal surrogates. We propose several methods for comparing candidate principal surrogates and evaluating multivariate principal surrogates. These include the time-dependent and surrogate-dependent true and false positive fraction, the time-dependent and the integrated standardized total gain, and the cumulative distribution function of the risk difference. We illustrate the operating characteristics of our proposed methods in simulations and outline how these statistics can be used to evaluate and compare candidate principal surrogates. We use these methods to investigate candidate surrogates in the Diabetes Control and Complications Trial. Copyright © 2014 John Wiley & Sons, Ltd.

Treatment of reflux gastritis: double blind comparison between clebopride and domperidone. A preliminary report.

PubMed

Angelini, G; Castagnini, A; Rizzoli, R; Pasini, A F; Lavarini, E; Brocco, G; Scuro, L A

1990-02-01

Altered gastro-duodenal motility seems to be a major factor of alkaline gastritis. Therefore prokinetic drugs have been extensively used for the treatment of this disease. Aim of this study has been to compare the effects of domperidone with those of a more recent drug of the orthopramide class, clebopride. Thirty patients affected by reflux gastritis have been randomly allocated to one of the two treatments. Clinical symptoms, endoscopic and histologic appearance of gastric mucosa, gastric pH and bile acid concentration in gastric juice have been evaluated before and after a four week course of therapy. A statistically significant improvement was observed for the clinical symptoms in the subjects treated with clebopride. Even if no statistical difference has been pointed out for the other parameters between and within the two groups, a slight trend in favour of clebopride was observed. It is concluded that clebopride is at least as effective as domperidone for the treatment of reflux gastritis but that more prolonged studies and different administration schedules are requested for a better evaluation.

Perforated posterior cecal diverticulum: challenges in establishing an accurate preoperative diagnosis of a rare emergency.

PubMed

Salemis, Nikolaos S; Grapatsas, Konstantinos; Matzoukas, Ioannis; Lagoudianakis, Emmanuel

2015-03-01

Solitary cecal diverticulitis is a rare cause of abdominal pain in Western countries. The preoperative diagnosis is very difficult to establish and most patients are operated on with a presumptive diagnosis of acute appendicitis based on clinical grounds. We describe a very rare case of perforated posterior cecal diverticulum and discuss the challenges in establishing a correct preoperative diagnosis. We conclude that although very rare, the possibility of perforated posteriorcecal diverticulum should always be considered in the differential diagnosis of patients presenting with atypical clinical manifestations of acute appendicitis. A perforation of a posterior cecal diverticulum maybe associated with a mild clinical course without signs of peritonitis. Athorough preoperative evaluation including a computed tomography scan is essential in order to establish a correct preoperative diagnosis which is of utmost importance for treatment planning in the emergency setting. Simple diverticulectomy is an effective surgical treatment in the absence of extensive inflammatory changes and when a colonic tumor can be ruled out.

Simulation techniques in hyperthermia treatment planning

PubMed Central

Paulides, MM; Stauffer, PR; Neufeld, E; Maccarini, P; Kyriakou, A; Canters, RAM; Diederich, C; Bakker, JF; Van Rhoon, GC

2013-01-01

Clinical trials have shown that hyperthermia (HT), i.e. an increase of tissue temperature to 39-44°C, significantly enhance radiotherapy and chemotherapy effectiveness (1). Driven by the developments in computational techniques and computing power, personalized hyperthermia treatment planning (HTP) has matured and has become a powerful tool for optimizing treatment quality. Electromagnetic, ultrasound, and thermal simulations using realistic clinical setups are now being performed to achieve patient-specific treatment optimization. In addition, extensive studies aimed to properly implement novel HT tools and techniques, and to assess the quality of HT, are becoming more common. In this paper, we review the simulation tools and techniques developed for clinical hyperthermia, and evaluate their current status on the path from “model” to “clinic”. In addition, we illustrate the major techniques employed for validation and optimization. HTP has become an essential tool for improvement, control, and assessment of HT treatment quality. As such, it plays a pivotal role in the quest to establish HT as an efficacious addition to multi-modality treatment of cancer. PMID:23672453

Clinically distinct presentations of copper deficiency myeloneuropathy and cytopenias in a patient using excessive zinc-containing denture adhesive.

PubMed

Cathcart, Sahara J; Sofronescu, Alina G

2017-08-01

While copper deficiency has long been known to cause cytopenias, copper deficiency myeloneuropathy is a more recently described entity. Here, we present the case of two clinically distinct presentations of acquired copper deficiency syndromes secondary to excessive use of zinc-containing denture adhesive over five years: myeloneuropathy and severe macrocytic anemia and neutropenia. Extensive laboratory testing and histologic evaluation of the liver and bone marrow, were necessary to rule out other disease processes and establish the diagnosis of copper deficiency. The initial presentation consisted of a myelopathy involving the posterior columns. Serum and urine copper were significantly decreased, and serum zinc was elevated. On second presentation (five years later), multiple hematological abnormalities were detected. Serum copper was again decreased, while serum zinc was elevated. Zinc overload is a preventable cause of copper deficiency syndromes. This rare entity presented herein highlights the importance of patient, as well as provider, education. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

A Qualitative Evaluation of Barriers to Care for Trauma-Related Mental Health Problems Among Low-Income Minorities in Primary Care

PubMed Central

Chung, Joyce Y.; Frank, Lori; Subramanian, Asha; Galen, Steve; Leonhard, Sarah; Green, Bonnie L.

2012-01-01

This study aimed to identify barriers and facilitators of mental health care for patients with trauma histories via qualitative methods with clinicians and administrators from primary care clinics for the underserved. Individual interviews were conducted, followed by a combined focus group with administrators from three jurisdictions; there were three focus groups with clinicians from each clinic system. Common themes were identified, and responses from groups were compared. Administrators and clinicians report extensive trauma histories among patients. Clinician barriers include lack of time, patient resistance, and inadequate referral options; administrators cite reimbursement issues, staff training, and lack of clarity about the term trauma. A key facilitator is doctor-patient relationship. There were differences in perceived barriers and facilitators at the institutional and clinical levels for mental health care for patients with trauma. Importantly, there is agreement about better access to and development of trauma-specific interventions. Findings will aid the development and implementation of trauma-focused interventions embedded in primary care. PMID:22551798

Clinical characteristics of children with mental retardation of unknown etiology in Korea.

PubMed Central

Yim, S. Y.; Lee, I. Y.

1999-01-01

The purpose of this study was to investigate the clinical characteristics of children with mental retardation (MR) of unknown etiology for early recognition and intervention. In this study, we defined children with MR of unknown etiology as those without clear etiologies for MR despite extensive evaluation and were not associated with pathological behavioral problems such as pervasive developmental disorders and attention-deficit/hyperactivity disorder. The clinical characteristics of children with MR of unknown etiology were as follows. 1) MR of unknown etiology was 48.8% of all MR. 2) MR of unknown etiology was more common in males. 3) Delayed language development was a leading factor that made the parents of children with MR of unknown etiology seek help from physicians. However, most of the children with MR of unknown etiology showed a relatively uniform delay in several areas of development. 4) Most children with MR of unknown etiology were delayed walkers. 5) Most children with MR of unknown etiology were mild cases. PMID:10331556

Malignant pleural mesothelioma: a phase II trial with docetaxel.

PubMed

Vorobiof, D A; Rapoport, B L; Chasen, M R; Abratt, R P; Cronje, N; Fourie, L; McMichael, G; Hacking, D

2002-03-01

Current cytotoxic therapy has been of limited benefit to patients with malignant pleural mesothelioma. Single agent chemotherapy has been extensively evaluated in small series of phase II clinical trials, with disappointing responses. Docetaxel, an effective taxane in the treatment of advanced breast cancer and non-small-cell lung cancer, was administered intravenously at a dose of 100 mg/m2 every 3 weeks to 30 chemotherapy naive patients with malignant pleural mesothelioma in a prospective multi-institutional phase II clinical trial. An objective response rate (partial responses) of 10% was documented. Additionally, 21% of the patients had minor responses (intention-to-treat analysis). Three patients died within 2 weeks post-first cycle of therapy, although only one patient's death was directly attributed to the investigational drug, whilst in the majority of the patients, manageable and treatable toxicities were encountered. In this phase II clinical trial, docetaxel proved to be mildly effective in the treatment of patients with malignant pleural mesothelioma.

The role of technetium-99m stannous pyrophosphate in myocardial imaging to recognize, localize and identify extension of acute myocardial infarction in patients

NASA Technical Reports Server (NTRS)

Willerson, J. T.; Parkey, R. W.; Bonte, F. J.; Stokely, E. M.; Buja, E. M.

1975-01-01

The ability of technetium-99m stannous pyrophosphate myocardial scintigrams to aid diagnostically in recognizing, localizing, and identifying extension of acute myocardial infarction in patients was evaluated. The present study is an extension of previous animal and patient evaluations that were recently performed utilizing this myocardial imaging agent.

Investigations of the pushability behavior of cardiovascular angiographic catheters.

PubMed

Bloss, Peter; Rothe, Wolfgang; Wünsche, Peter; Werner, Christian; Rothe, Alexander; Kneissl, Georg Dieter; Burger, Wolfram; Rehberg, Elisabeth

2003-01-01

The placement of angiographic catheters into the vascular system is a routine procedure in modern clinical business. The definition of objective but not yet available evaluation protocols based on measurable physical quantities correlated to the empirical clinical findings is of utmost importance for catheter manufacturers for in-house product screening and optimization. In this context, we present an assessment of multiple mechanical and surface catheter properties such as static and kinetic friction, bending stiffness, microscopic surface topology, surface roughness, surface free energy and their interrelation. Theoretical framework, description of experimental methods and extensive data measured on several different catheters are provided and in conclusion a testing procedure is defined. Although this procedure is based on the measurement of several physical quantities it can be easily implemented by commercial laboratories testing catheters as it is based on relatively low-cost standard methods.

Reengineering NHS Hospitals in Greece: Redistribution Leads to Rational Mergers.

PubMed

Nikolentzos, Athanasios; Kontodimopoulos, Nick; Polyzos, Nikolaos; Thireos, Eleftherios; Tountas, Yannis

2015-03-18

The purpose of this study was to record and evaluate existing public hospital infrastructure of the National Health System (NHS), in terms of clinics and laboratories, as well as the healthcare workforce in each of these units and in every health region in Greece, in an attempt to optimize the allocation of these resources. An extensive analysis of raw data according to supply and performance indicators was performed to serve as a solid and objective scientific baseline for the proposed reengineering of the Greek public hospitals. Suggestions for "reshuffling" clinics and diagnostic laboratories, and their personnel, were made by using a best versus worst outcome indicator approach at a regional and national level. This study is expected to contribute to the academic debate about the gap between theory and evidence based decision-making in health policy.

Reengineering NHS Hospitals in Greece: Redistribution Leads to Rational Mergers

PubMed Central

Nikolentzos, Athanasios; Kontodimopoulos, Nick; Polyzos, Nikolaos; Thireos, Eleftherios; Tountas, Yannis

2015-01-01

The purpose of this study was to record and evaluate existing public hospital infrastructure of the National Health System (NHS), in terms of clinics and laboratories, as well as the healthcare workforce in each of these units and in every health region in Greece, in an attempt to optimize the allocation of these resources. An extensive analysis of raw data according to supply and performance indicators was performed to serve as a solid and objective scientific baseline for the proposed reengineering of the Greek public hospitals. Suggestions for “reshuffling” clinics and diagnostic laboratories, and their personnel, were made by using a best versus worst outcome indicator approach at a regional and national level. This study is expected to contribute to the academic debate about the gap between theory and evidence based decision-making in health policy. PMID:26156925

Sleep-obesity relation: underlying mechanisms and consequences for treatment.

PubMed

St-Onge, M-P

2017-02-01

Short sleep duration has been associated with obesity in numerous epidemiological studies. However, such association studies cannot establish evidence of causality. Clinical intervention studies, on the other hand, can provide information on a causal effect of sleep duration on markers of weight gain: energy intake and energy expenditure. Herein is an overview of the science related to the impact of sleep restriction, in the context of clinical intervention studies, on energy intake, energy expenditure and body weight. Additionally, studies that evaluate the impact of sleep restriction on weight loss and the impact of sleep extension on appetite are discussed. Information to date suggests that weight management is hindered when attempted in the context of sleep restriction, and the public should be made aware of the negative consequences of sleep restriction for weight regulation. © 2017 World Obesity Federation.

Acute closed radial nerve injury

PubMed Central

Tuncel, Umut; Turan, Aydin; Kostakoglu, Naci

2011-01-01

We present a 45-year-old patient who had acute radial nerve palsy following a blunt trauma without any fracture or dislocation. He was injured by strucking in a combat three months ago. The patient has been followed by application of a long-arm plaster cast before referred to our clinic. Preoperative electromyoneurography and magnetic resonance imaging (MRI) indicated that there was a radial nerve injury on humeral groove. The British Medical Research Council (MRC) grade was 2/5 on his wrist preoperatively. The patient underwent an operation under general anesthesia. It was seen to be a second-degree nerve injury. The patient has subsequently regained full movement on his wrist and finger extension in six months. We suggest that a detailed clinical and electrodiagnostical evaluation is necessary in patients who have radial nerve injury when deciding the treatment, conservative or surgical. PMID:22347334

The effectiveness of Kinesio Taping® after total knee replacement in early postoperative rehabilitation period. A randomized controlled trial.

PubMed

Donec, V; Kriščiūnas, A

2014-08-01

The number of total knee replacements performed each year is increasing. Among the main impediments to functional recovery after these surgeries include postoperative edema, pain, lower limb muscle strength deficits, all of which point to a need to identify safe, effective postoperative rehabilitation modalities. The aim of this paper was to evaluate the effectiveness of Kinesio Taping® (KT) method in reducing postoperative pain, edema, and improved knee range of motion recovery after total knee replacement (TKR) operation in early postoperative rehabilitation period. Randomized clinical trial. Inpatient rehabilitation facility. Ninety-four patients, who underwent primary TKR surgery. Using simple randomization, participants were divided into KT group and control group. Both groups received same rehabilitation program and procedures after surgery, except KT group also received KT applications throughout all rehabilitation period. Postoperative pain, edema, restoration of the operated knee flexion and extension were evaluated. The chosen level of significance was P<0.05; in evaluation power of the test β ≤ 0.2. Groups were homogenous to sex, age, BMI, comorbidities, preoperative knee flexion/extension impairment, preoperative pain intensity, anaesthesia, prosthesis implanted (P>0.05). In both groups postoperative pain decreased significantly during rehabilitation period, however less pain was found in KT group from the second postoperative week till the end of inpatient rehabilitation (28th postoperative day) (P<0.05; β ≤ 0.2). Postoperative edema was less intense and subsided more quickly in KT group as well (P<0.05; β ≤ 0.2). No difference was found in improvement of knee flexion (P>0.05). Operated knee extension was found better in KT group then in control at the end of in-patient rehabilitation (P<0.05; β ≤ 0.2). KT was well tolerated by patients. KT technique appeared to be beneficial for reducing postoperative pain, edema, improving knee extension in early postoperative rehabilitation period. This finding implies for health care professionals working in the field of physical medicine and rehabilitation that Kinesio Taping® method is safe and can be used as additional rehabilitation means for patients after TKR.

An open-label study to evaluate the long-term safety and efficacy of lanadelumab for prevention of attacks in hereditary angioedema: design of the HELP study extension.

PubMed

Riedl, Marc A; Bernstein, Jonathan A; Craig, Timothy; Banerji, Aleena; Magerl, Markus; Cicardi, Marco; Longhurst, Hilary J; Shennak, Mustafa M; Yang, William H; Schranz, Jennifer; Baptista, Jovanna; Busse, Paula J

2017-01-01

Hereditary angioedema (HAE) is characterized by recurrent attacks of subcutaneous or submucosal edema. Attacks are unpredictable, debilitating, and have a significant impact on quality of life. Patients may be prescribed prophylactic therapy to prevent angioedema attacks. Current prophylactic treatments may be difficult to administer (i.e., intravenously), require frequent administrations or are not well tolerated, and breakthrough attacks may still occur frequently. Lanadelumab is a subcutaneously-administered monoclonal antibody inhibitor of plasma kallikrein in clinical development for prophylaxis of hereditary angioedema attacks. A Phase 1b study supported its efficacy in preventing attacks. A Phase 3, randomized, double-blind, placebo-controlled, parallel-arm study has been completed and an open-label extension is currently ongoing. The primary objective of the open-label extension is to evaluate the long-term safety of repeated subcutaneous administrations of lanadelumab in patients with type I/II HAE. Secondary objectives include evaluation of efficacy and time to first angioedema attack to determine outer bounds of the dosing interval. The study will also evaluate immunogenicity, pharmacokinetics/pharmacodynamics, quality of life, characteristics of breakthrough attacks, ease of self-administration, and safety/efficacy in patients who switch to lanadelumab from another prophylactic therapy. The open-label extension will enroll patients who completed the double-blind study ("rollover patients") and those who did not participate in the double-blind study ("non-rollover patients"), which includes patients who may or may not be currently using another prophylactic therapy. Rollover patients will receive a single 300 mg dose of lanadelumab on Day 0 and the second dose after the patient's first confirmed angioedema attack. Thereafter, lanadelumab will be administered every 2 weeks. Non-rollover patients will receive 300 mg lanadelumab every 2 weeks regardless of the first attack. All patients will receive their last dose on Day 350 (maximum of 26 doses), and will then undergo a 4-week follow-up. Prevention of attacks can reduce the burden of illness associated with HAE. Prophylactic therapy requires extended, repeated dosing and the results of this study will provide important data on the long-term safety and efficacy of lanadelumab, a monoclonal antibody inhibitor of plasma kallikrein for subcutaneous administration for the treatment of HAE. Trial registration NCT02741596.

Value Driven Outcomes (VDO): a pragmatic, modular, and extensible software framework for understanding and improving health care costs and outcomes

PubMed Central

Kawamoto, Kensaku; Martin, Cary J; Williams, Kip; Tu, Ming-Chieh; Park, Charlton G; Hunter, Cheri; Staes, Catherine J; Bray, Bruce E; Deshmukh, Vikrant G; Holbrook, Reid A; Morris, Scott J; Fedderson, Matthew B; Sletta, Amy; Turnbull, James; Mulvihill, Sean J; Crabtree, Gordon L; Entwistle, David E; McKenna, Quinn L; Strong, Michael B; Pendleton, Robert C; Lee, Vivian S

2015-01-01

Objective To develop expeditiously a pragmatic, modular, and extensible software framework for understanding and improving healthcare value (costs relative to outcomes). Materials and methods In 2012, a multidisciplinary team was assembled by the leadership of the University of Utah Health Sciences Center and charged with rapidly developing a pragmatic and actionable analytics framework for understanding and enhancing healthcare value. Based on an analysis of relevant prior work, a value analytics framework known as Value Driven Outcomes (VDO) was developed using an agile methodology. Evaluation consisted of measurement against project objectives, including implementation timeliness, system performance, completeness, accuracy, extensibility, adoption, satisfaction, and the ability to support value improvement. Results A modular, extensible framework was developed to allocate clinical care costs to individual patient encounters. For example, labor costs in a hospital unit are allocated to patients based on the hours they spent in the unit; actual medication acquisition costs are allocated to patients based on utilization; and radiology costs are allocated based on the minutes required for study performance. Relevant process and outcome measures are also available. A visualization layer facilitates the identification of value improvement opportunities, such as high-volume, high-cost case types with high variability in costs across providers. Initial implementation was completed within 6 months, and all project objectives were fulfilled. The framework has been improved iteratively and is now a foundational tool for delivering high-value care. Conclusions The framework described can be expeditiously implemented to provide a pragmatic, modular, and extensible approach to understanding and improving healthcare value. PMID:25324556

Neuroimaging findings of extensive sphenoethmoidal dysplasia in NF1.

PubMed

Tam, Allison; Sliepka, Joseph M; Bellur, Sunil; Bray, Collin Douglas; Lincoln, Christie M; Nagamani, Sandesh C S

2018-05-16

Whereas isolated sphenoid wing dysplasia (SWD) is a well-known clinical feature in neurofibromatosis 1 (NF1), extensive cranial defects involving multiple bones have been rarely reported in this disorder. In this report, we describe the clinical course of a 20-year-old male with NF1 and an extensive cranial bone dysplasia. The large sphenoethmoidal defect was associated with transethmoidal and orbital cephalocele as well as inferolateral herniation of the frontal lobe. In spite of the large defect, the individual did not have any symptoms or complications resulting from the osteopathy. We review the current knowledge of the pathogenesis and management of cranial bone dysplasia in NF1. Copyright © 2018 Elsevier Inc. All rights reserved.

Impact of Primary Gleason Grade on Risk Stratification for Gleason Score 7 Prostate Cancers

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

Koontz, Bridget F., E-mail: bridget.koontz@duke.edu; Tsivian, Matvey; Mouraviev, Vladimir

Purpose: To evaluate the primary Gleason grade (GG) in Gleason score (GS) 7 prostate cancers for risk of non-organ-confined disease with the goal of optimizing radiotherapy treatment option counseling. Methods: One thousand three hundred thirty-three patients with pathologic GS7 were identified in the Duke Prostate Center research database. Clinical factors including age, race, clinical stage, prostate-specific antigen at diagnosis, and pathologic stage were obtained. Data were stratified by prostate-specific antigen and clinical stage at diagnosis into adapted D'Amico risk groups. Univariate and multivariate analyses were performed evaluating for association of primary GG with pathologic outcome. Results: Nine hundred seventy-nine patientsmore » had primary GG3 and 354 had GG4. On univariate analyses, GG4 was associated with an increased risk of non-organ-confined disease. On multivariate analysis, GG4 was independently associated with seminal vesicle invasion (SVI) but not extracapsular extension. Patients with otherwise low-risk disease and primary GG3 had a very low risk of SVI (4%). Conclusions: Primary GG4 in GS7 cancers is associated with increased risk of SVI compared with primary GG3. Otherwise low-risk patients with GS 3+4 have a very low risk of SVI and may be candidates for prostate-only radiotherapy modalities.« less

Development of replication-deficient adenovirus malaria vaccines.

PubMed

Hollingdale, Michael R; Sedegah, Martha; Limbach, Keith

2017-03-01

Malaria remains a major threat to endemic populations and travelers, including military personnel to these areas. A malaria vaccine is feasible, as radiation attenuated sporozoites induce nearly 100% efficacy. Areas covered: This review covers current malaria clinical trials using adenoviruses and pre-clinical research. Heterologous prime-boost regimens, including replication-deficient human adenovirus 5 (HuAd5) carrying malaria antigens, are efficacious. However, efficacy appears to be adversely affected by pre-existing anti-HuAd5 antibodies. Current strategies focus on replacing HuAd5 with rarer human adenoviruses or adenoviruses isolated from non-human primates (NHPs). The chimpanzee adenovirus ChAd63 is undergoing evaluation in clinical trials including infants in malaria-endemic areas. Key antigens have been identified and are being used alone, in combination, or with protein subunit vaccines. Gorilla adenoviruses carrying malaria antigens are also currently being evaluated in preclinical models. These replacement adenovirus vectors will be successfully used to develop vaccines against malaria, as well as other infectious diseases. Expert commentary: Simplified prime-boost single shot regimens, dry-coated live vector vaccines or silicon microneedle arrays could be developed for malaria or other vaccines. Replacement vectors with similar or superior immunogenicity have rapidly advanced, and several are now in extensive Phase 2 and beyond in malaria as well as other diseases, notably Ebola.

Impact of primary Gleason grade on risk stratification for Gleason score 7 prostate cancers.

PubMed

Koontz, Bridget F; Tsivian, Matvey; Mouraviev, Vladimir; Sun, Leon; Vujaskovic, Zeljko; Moul, Judd; Lee, W Robert

2012-01-01

To evaluate the primary Gleason grade (GG) in Gleason score (GS) 7 prostate cancers for risk of non-organ-confined disease with the goal of optimizing radiotherapy treatment option counseling. One thousand three hundred thirty-three patients with pathologic GS7 were identified in the Duke Prostate Center research database. Clinical factors including age, race, clinical stage, prostate-specific antigen at diagnosis, and pathologic stage were obtained. Data were stratified by prostate-specific antigen and clinical stage at diagnosis into adapted D'Amico risk groups. Univariate and multivariate analyses were performed evaluating for association of primary GG with pathologic outcome. Nine hundred seventy-nine patients had primary GG3 and 354 had GG4. On univariate analyses, GG4 was associated with an increased risk of non-organ-confined disease. On multivariate analysis, GG4 was independently associated with seminal vesicle invasion (SVI) but not extracapsular extension. Patients with otherwise low-risk disease and primary GG3 had a very low risk of SVI (4%). Primary GG4 in GS7 cancers is associated with increased risk of SVI compared with primary GG3. Otherwise low-risk patients with GS 3+4 have a very low risk of SVI and may be candidates for prostate-only radiotherapy modalities. Copyright © 2012 Elsevier Inc. All rights reserved.

Executive summary of the diagnosis and treatment of urinary tract infection: Guidelines of the Spanish Society of Clinical Microbiology and Infectious Diseases (SEIMC).

PubMed

de Cueto, Marina; Aliaga, Luis; Alós, Juan-Ignacio; Canut, Andres; Los-Arcos, Ibai; Martínez, Jose Antonio; Mensa, Jose; Pintado, Vicente; Rodriguez-Pardo, Dolors; Yuste, Jose Ramon; Pigrau, Carles

2017-05-01

Most urinary tract infections (UTI) are uncomplicated infections occurring in young women. An extensive evaluation is not required in the majority of cases, and they can be safely managed as outpatients with oral antibiotics. Escherichia coli is by far the most common uropathogen, accounting for >80% of all cases. Other major clinical problems associated with UTI include asymptomatic bacteriuria, and patients with complicated UTI. Complicated UTIs are a heterogeneous group associated with conditions that increase the risk of acquiring infection or treatment failure. Distinguishing between complicated and uncomplicated UTI is important, as it influences the initial evaluation, choice, and duration of antimicrobial therapy. Diagnosis is especially challenging in the elderly and in patients with in-dwelling catheters. The increasing prevalence of resistant uropathogens, including extended-spectrum β-lactamases and carbapenemase-producing Enterobacteriaceae, and other multidrug-resistant Gram-negative organisms further compromises treatment of both complicated and uncomplicated UTIs. The aim of these Clinical Guidelines is to provide a set of recommendations for improving the diagnosis and treatment of UTI. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Enfermedades Infecciosas y Microbiología Clínica. All rights reserved.

Development and Evaluation of Methods for Structured Recording of Heart Murmur Findings Using SNOMED-CT® Post-Coordination

PubMed Central

Green, Julie M.; Wilcke, Jeffrey R.; Abbott, Jonathon; Rees, Loren P.

2006-01-01

Objective: This study evaluated an existing SNOMED-CT® model for structured recording of heart murmur findings and compared it to a concept-dependent attributes model using content from SNOMED-CT. Methods: The authors developed a model for recording heart murmur findings as an alternative to SNOMED-CT's use of Interprets and Has interpretation. A micro-nomenclature was then created to support each model using subset and extension mechanisms described for SNOMED-CT. Each micro-nomenclature included a partonomy of cardiac cycle timing values. A mechanism for handling ranges of values was also devised. One hundred clinical heart murmurs were recorded using purpose-built recording software based on both models. Results: Each micro-nomenclature was extended through the addition of the same list of concepts. SNOMED role grouping was required in both models. All 100 clinical murmurs were described using each model. The only major differences between the two models were the number of relationship rows required for storage and the hierarchical assignments of concepts within the micro-nomenclatures. Conclusion: The authors were able to capture 100 clinical heart murmurs with both models. Requirements for implementing the two models were virtually identical. In fact, data stored using these models could be easily interconverted. There is no apparent penalty for implementing either approach. PMID:16501179

The STENTYS self-apposing stent technology in coronary artery disease: literature review and future directions.

PubMed

Lu, Huangling; de Winter, Robbert J; Koch, Karel T

2018-06-21

Coronary stent designs have been through extensive developments in the past few decades. Since the first introduction of the self-apposing STENTYS stent, several theoretical advantages of its nitinol platform have been clinically evaluated. This paper reviews the current status, ongoing work and future directions of this device. Areas covered: The OPEN (STENTYS Coronary Bifurcation Stent System fOr the PErcutaNeous treatment of de novo lesions in native bifurcated coronary arteries) trials revealed high technical success rates of the STENTYS performance in bifurcation lesions. The APPOSITION (Assessment of the Safety and Performance of the STENTYS self-expanding Coronary Stent in Acute Myocardial Infarction) trials demonstrated the safety and feasibility of the device in patients with acute myocardial infarction. Optical coherence tomography showed better short-term strut apposition in patients treated with the STENTYS stent in APPOSITION IV. The clinical outcomes of the device in saphenous vein graft lesions and left main coronary artery disease are favourable. Expert Commentary: Despite numerous theoretical advantages of the nitinol platform, superiority of the STENTYS self-apposing stent over currently available DES has not yet been proven. However, the ongoing registries evaluating the performance of the STENTYS Xposition will provide more insights in its clinical performance.

How Hedstrom files fail during clinical use? A retrieval study based on SEM, optical microscopy and micro-XCT analysis.

PubMed

Zinelis, Spiros; Al Jabbari, Youssef S

2018-05-01

This study was conducted to evaluate the failure mechanism of clinically failed Hedstrom (H)-files. Discarded H-files (n=160) from #8 to #40 ISO sizes were collected from different dental clinics. Retrieved files were classified according to their macroscopic appearance and they were investigated under scanning electron microscopy (SEM) and X-ray micro-computed tomography (mXCT). Then the files were embedded in resin along their longitudinal axis and after metallographic grinding and polishing, studied under an incident light microscope. The macroscopic evaluation showed that small ISO sizes (#08-#15) failed by extensive plastic deformation, while larger sizes (≥#20) tended to fracture. Light microscopy and mXCT results coincided showing that unused and plastically deformed files were free of internal defects, while fractured files demonstrate the presence of intense cracking in the flute region. SEM analysis revealed the presence of striations attributed to the fatigue mechanism. Secondary cracks were also identified by optical microscopy and their distribution was correlated to fatigue under bending loading. Experimental results demonstrated that while overloading of cutting instruments is the predominating failure mechanism of small file sizes (#08-#15), fatigue should be considered the fracture mechanism for larger sizes (≥#20).

Xeroderma pigmentosum and Cockayne syndrome: overlapping clinical and biochemical phenotypes.

PubMed Central

Greenhaw, G A; Hebert, A; Duke-Woodside, M E; Butler, I J; Hecht, J T; Cleaver, J E; Thomas, G H; Horton, W A

1992-01-01

Two siblings are described whose clinical presentation of cutaneous photosensitivity and central nervous system dysfunction is strongly reminiscent of the DeSanctis-Cacchione syndrome (DCS) variant of xeroderma pigmentosum. An extensive clinical evaluation supported a diagnosis of DCS and documented previously unreported findings. In vitro fibroblast studies showed UV sensitivity that was two to three times that of normal controls. However, neither a post-UV-irradiation DNA excision-repair defect indicative of XP nor a semiconservative DNA replication defect indicative of XP variant was found. Rather, a failure of RNA synthesis to recover to normal levels after UV exposure was observed, a biochemical abnormality seen in Cockayne syndrome (CS), one of the premature-aging syndromes with clinical UV sensitivity. These patients, therefore, clinically have XP, but their biochemical characteristics suggest CS. The reason(s) for the severe neurologic disease, in light of the relatively mild cutaneous abnormalities, is unclear. Other cases with unusual fibroblast responses to irradiation have been noted in the literature and, along with the data from our patients, reinforce the notion of the complexity of DNA maintenance and repair. Images Figure 1 Figure 1 Figure 2 Figure 3 PMID:1372469

Empirical testing of criteria for dissociative schizophrenia.

PubMed

Laferrière-Simard, Marie-Christine; Lecomte, Tania; Ahoundova, Lola

2014-01-01

This study examined the validity of dissociative schizophrenia diagnostic criteria. In the first phase, 50 participants with a psychotic disorder were administered the Dissociative Experiences Scale and the Childhood Trauma Questionnaire to identify those with dissociative characteristics. In the second phase, we selected those who had a score of 15 or above on the Dissociative Experiences Scale. Fifteen of these participants were evaluated thoroughly with the Structured Clinical Interview for DSM-IV Axis I, Structured Clinical Interview for DSM-IV Axis II, and Structured Clinical Interview for DSM-IV Dissociative Disorders to determine whether they met the criteria for dissociative schizophrenia and to generate a clinical description. Our results indicated that 24% of the individuals we tested met these criteria. We propose making mandatory 1 of the 3 dissociative symptoms of the criteria to eliminate people with only nonspecific symptoms (e.g., extensive comorbidity). According to this modified criterion, 14% of our sample would receive a diagnosis of dissociative schizophrenia. However, a more comprehensive look at the clinical picture begs the question of whether dissociative schizophrenia is truly present in every person meeting the criteria. We discuss the relevance of creating a new schizophrenia subtype and offer recommendations for clinicians.

MendeLIMS: a web-based laboratory information management system for clinical genome sequencing.

PubMed

Grimes, Susan M; Ji, Hanlee P

2014-08-27

Large clinical genomics studies using next generation DNA sequencing require the ability to select and track samples from a large population of patients through many experimental steps. With the number of clinical genome sequencing studies increasing, it is critical to maintain adequate laboratory information management systems to manage the thousands of patient samples that are subject to this type of genetic analysis. To meet the needs of clinical population studies using genome sequencing, we developed a web-based laboratory information management system (LIMS) with a flexible configuration that is adaptable to continuously evolving experimental protocols of next generation DNA sequencing technologies. Our system is referred to as MendeLIMS, is easily implemented with open source tools and is also highly configurable and extensible. MendeLIMS has been invaluable in the management of our clinical genome sequencing studies. We maintain a publicly available demonstration version of the application for evaluation purposes at http://mendelims.stanford.edu. MendeLIMS is programmed in Ruby on Rails (RoR) and accesses data stored in SQL-compliant relational databases. Software is freely available for non-commercial use at http://dna-discovery.stanford.edu/software/mendelims/.

[Metallo-beta-lactamase-mediated resistance among carbapenem-resistant Pseudomonas aeruginosa clinical isolates].

PubMed

Mereuţă, Ana Irina; Tuchiluş, Cristina; Bădescu, Aida Corina; Iancu, Luminiţa Smaranda

2011-01-01

The aim of our study was to evaluate the antimicrobial susceptibility profile and the presence of metallo-beta-lactamases (MBLs) among carbapenem-resistant Pseudomonas aeruginosa clinical isolates. A total of 84 P. aeruginosa clinical isolates collected between January 2007- February 2011 from four university hospitals in Iasi (North-East region of Romania) were randomly selected. Antimicrobial susceptibility testing was performed according to CLSI 2010 (Clinical and Laboratory Standards Institute) guidelines. The isolates were tested for MBLs using EPI (EDTA-phenanthroline-imipenem) phenotypic test and polymerase chain reaction (PCR) for bla(VIM) and bla(IMP). Fifty-eight carbapenem resistant strains were identified, from which 24 (41,3%) were positive for VIM-type MBLs. No IMP - type MBL was detected. All MBL-producing isolates displayed a MDR (multidrug resistant) phenotype, two of them were XDR (extensively drug-resistant). Colistin remained the most effective antibiotic. The high proportion of MBL producing P. aeruginosa clinical isolates urges the need for a better use of antibiotics and for efficient infection control measures to prevent dissemination of MBL producers. This is the first report of VIM-like enzymes in P. aeruginosa isolates from the Iasi area.

SU-F-J-72: A Clinical Usable Integrated Contouring Quality Evaluation Software for Radiotherapy

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

Jiang, S; Dolly, S; Cai, B

Purpose: To introduce the Auto Contour Evaluation (ACE) software, which is the clinical usable, user friendly, efficient and all-in-one toolbox for automatically identify common contouring errors in radiotherapy treatment planning using supervised machine learning techniques. Methods: ACE is developed with C# using Microsoft .Net framework and Windows Presentation Foundation (WPF) for elegant GUI design and smooth GUI transition animations through the integration of graphics engines and high dots per inch (DPI) settings on modern high resolution monitors. The industrial standard software design pattern, Model-View-ViewModel (MVVM) pattern, is chosen to be the major architecture of ACE for neat coding structure, deepmore » modularization, easy maintainability and seamless communication with other clinical software. ACE consists of 1) a patient data importing module integrated with clinical patient database server, 2) a 2D DICOM image and RT structure simultaneously displaying module, 3) a 3D RT structure visualization module using Visualization Toolkit or VTK library and 4) a contour evaluation module using supervised pattern recognition algorithms to detect contouring errors and display detection results. ACE relies on supervised learning algorithms to handle all image processing and data processing jobs. Implementations of related algorithms are powered by Accord.Net scientific computing library for better efficiency and effectiveness. Results: ACE can take patient’s CT images and RT structures from commercial treatment planning software via direct user input or from patients’ database. All functionalities including 2D and 3D image visualization and RT contours error detection have been demonstrated with real clinical patient cases. Conclusion: ACE implements supervised learning algorithms and combines image processing and graphical visualization modules for RT contours verification. ACE has great potential for automated radiotherapy contouring quality verification. Structured with MVVM pattern, it is highly maintainable and extensible, and support smooth connections with other clinical software tools.« less

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed

Bréant, C; Borst, F; Campi, D; Griesser, V; Momjian, S

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG.

A hospital-wide clinical findings dictionary based on an extension of the International Classification of Diseases (ICD).

PubMed Central

Bréant, C.; Borst, F.; Campi, D.; Griesser, V.; Momjian, S.

1999-01-01

The use of a controlled vocabulary set in a hospital-wide clinical information system is of crucial importance for many departmental database systems to communicate and exchange information. In the absence of an internationally recognized clinical controlled vocabulary set, a new extension of the International statistical Classification of Diseases (ICD) is proposed. It expands the scope of the standard ICD beyond diagnosis and procedures to clinical terminology. In addition, the common Clinical Findings Dictionary (CFD) further records the definition of clinical entities. The construction of the vocabulary set and the CFD is incremental and manual. Tools have been implemented to facilitate the tasks of defining/maintaining/publishing dictionary versions. The design of database applications in the integrated clinical information system is driven by the CFD which is part of the Medical Questionnaire Designer tool. Several integrated clinical database applications in the field of diabetes and neuro-surgery have been developed at the HUG. Images Figure 1 PMID:10566451

O8.10A MODEL FOR RESEARCH INITIATIVES FOR RARE CANCERS: THE COLLABORATIVE EPENDYMOMA RESEARCH NETWORK (CERN)

PubMed Central

Armstrong, T.S.; Aldape, K.; Gajjar, A.; Haynes, C.; Hirakawa, D.; Gilbertson, R.; Gilbert, M.R.

2014-01-01

Ependymoma represents less than 5% of adult central nervous system (CNS) tumors and a higher percentage of pediatric CNS tumors, but it remains an orphan disease. The majority of the laboratory-based research and clinical trials have been conducted in the pediatric setting, a reflection of the relative incidence and funding opportunities. CERN, created in 2006, was designed to establish a collaborative effort between laboratory and clinical research and pediatric and adult investigators. The organization of CERN is based on integration and collaboration among five projects. Project 1 contains the clinical trials network encompassing both adult and pediatric centers. This group has completed 2 clinical trials with more underway. Project 2 is focused on molecular classification of human ependymoma tumor tissues and also contains the tumor repository which has now collected over 600 fully clinically annotated CNS ependymomas from adults and children. Project 3 is focused on drug discovery utilizing robust laboratory models of ependymoma to perform high throughput screening of drug libraries, then taking promising agents through extensive preclinical testing including monitoring of drug delivery to tumor using state of the art microdialysis. Project 4 contains the basic research efforts evaluating the molecular pathogenesis of ependymoma and has successfully translated these findings by generating the first mouse models of ependymoma that are employed in preclinical drug development in Project 3. Project 5 studies patient outcomes, including the incorporation of these measures in the clinical trials. This project also contains an online Ependymoma Outcomes survey, collecting data on the consequences of the disease and its treatment. These projects have been highly successful and collaborative. For example, the serial measurement of symptom burden (Project 5) has greatly contributed to the evaluation of treatment efficacy of a clinical trial (Project 1) and investigators from Project 2 are evaluating potential predictive markers from tumor tissue from the same clinical trial. Results from genomic and molecular discoveries generated by Project 4 were evaluated using the clinical material from the Tumor Registry (Project 2). Agents identified from the high throughput screening in Project 3 are being used to create novel clinical trials (Project 1). As a complimentary effort, CERN's community outreach efforts provide a major gateway to patients, families, caregivers and healthcare providers, contributing to greater awareness of ependymoma, and supporting clinical trial accrual in Project 1. In summary, CERN has successfully created a collaborative, multi-national integrated effort combining pediatric- and adult-focused investigators spanning from basic science to patient outcomes measures. This research paradigm may be an effective approach for other rare cancers.

A patent extension proposal to end the underrepresentation of women in clinical trials and secure meaningful drug guidance for women.

PubMed

Hathaway, Cynthia

2012-01-01

Historically, women have been systematically excluded from or underrepresented in human clinical trials of new drugs. Due to fundamental physiological differences between women and men with regard to how drugs work in the human body, testing of drugs in men alone can both deny women the full benefit of a drug and cause them to suffer from increased adverse side effects. Attempts to reform drug development law and agency practices to resolve this problem have met with only partial success. Proposed herein is a patent term extension and for studies in women, modeled upon the pediatric patent term extension, but with several key differences intended to reduce the cost to the public and fund auxiliary programs to address off-patent medicines as well. Such an extension would incentivize this research and provide meaningful guidance to women and their physicians.

The stabilizing potential of anterior, posterior and combined techniques for the reconstruction of a 2-level cervical corpectomy model: biomechanical study and first results of ATPS prototyping.

PubMed

Koller, Heiko; Schmidt, Rene; Mayer, Michael; Hitzl, Wolfgang; Zenner, Juliane; Midderhoff, Stefan; Middendorf, Stefan; Graf, Nicolaus; Gräf, Nicolaus; Resch, H; Wilke, Hans-Joachim; Willke, Hans-Joachim

2010-12-01

Clinical studies reported frequent failure with anterior instrumented multilevel cervical corpectomies. Hence, posterior augmentation was recommended but necessitates a second approach. Thus, an author group evaluated the feasibility, pull-out characteristics, and accuracy of anterior transpedicular screw (ATPS) fixation. Although first success with clinical application of ATPS has already been reported, no data exist on biomechanical characteristics of an ATPS-plate system enabling transpedicular end-level fixation in advanced instabilities. Therefore, we evaluated biomechanical qualities of an ATPS prototype C4-C7 for reduction of range of motion (ROM) and primary stability in a non-destructive setup among five constructs: anterior plate, posterior all-lateral mass screw construct, posterior construct with lateral mass screws C5 + C6 and end-level fixation using pedicle screws unilaterally or bilaterally, and a 360° construct. 12 human spines C3-T1 were divided into two groups. Four constructs were tested in group 1 and three in group 2; the ATPS prototypes were tested in both groups. Specimens were subjected to flexibility test in a spine motion tester at intact state and after 2-level corpectomy C5-C6 with subsequent reconstruction using a distractable cage and one of the osteosynthesis mentioned above. ROM in flexion-extension, axial rotation, and lateral bending was reported as normalized values. All instrumentations but the anterior plate showed significant reduction of ROM for all directions compared to the intact state. The 360° construct outperformed all others in terms of reducing ROM. While there were no significant differences between the 360° and posterior constructs in flexion-extension and lateral bending, the 360° constructs were significantly more stable in axial rotation. Concerning primary stability of ATPS prototypes, there were no significant differences compared to posterior-only constructs in flexion-extension and axial rotation. The 360° construct showed significant differences to the ATPS prototypes in flexion-extension, while no significant differences existed in axial rotation. But in lateral bending, the ATPS prototype and the anterior plate performed significantly worse than the posterior constructs. ATPS was shown to confer increased primary stability compared to the anterior plate in flexion-extension and axial rotation with the latter yielding significance. We showed that primary stability after 2-level corpectomy reconstruction using ATPS prototypes compared favorably to posterior systems and superior to anterior plates. From the biomechanical point, the 360° instrumentation was shown the most efficient for reconstruction of 2-level corpectomies. Further studies will elucidate whether fatigue testing will enhance the benefit of transpedicular anchorage with posterior constructs and ATPS.

Primary extranodal marginal zone lymphoma of the uvea associated with massive diffuse epibulbar extension and focal infiltration of the optic nerve and meninges, clinically presented as uveitis masquerade syndrome: a case report.

PubMed

Rasić, D M; Stanković, Z; Terzić, T; Kovacević, D; Koturović, Z; Marković, V

2010-09-01

To report a clinical, histopathological and immunohistochemical findings in a case of primary extranodal marginal zone lymphoma of the uvea associated with massive diffuse extraocular episcleral extension and focal infiltration of the optic nerve and meninges, clinically presented as longstanding uveitis masquerade syndrome. Interventional case reports with histopathological correlation. We describe a 80-year-old male patient with a 3-year history of chronic recurrent hypertensive (pan) uveitis associated with ocular pain, unresponsive to topical and systemic anti-inflammatory, immunosuppressive, antibiotic/antiviral and antiglaucomatous therapy. Because the eye was not salvageable with conservative treatment, enucleation of blind and painful eye was performed. Findings from histopathological and immunohistochemistry examination of the enucleated eye showed an extranodal marginal zone lymphoma of the uveal tract with massive epibulbar extension and optic nerve and meningeal penetration. During almost 3 years of clinical course and 6 months after the enucleation, there were no systemic manifestations of lymphoma, and patient has not required subsequent treatment. Primary lymphoproliferative lesions of the uvea, comprising the iris, ciliary body and choroid are very rare, associated with epibulbar extension extremely and with optic nerve and menigeal penetration exceptionally. Despite its rarity, primary lymphoma of the uvea should be included in the differential diagnosis particularly in older patients with longstanding recurrent uveitis.

Anniversary Paper: History and status of CAD and quantitative image analysis: The role of Medical Physics and AAPM

PubMed Central

Giger, Maryellen L.; Chan, Heang-Ping; Boone, John

2008-01-01

The roles of physicists in medical imaging have expanded over the years, from the study of imaging systems (sources and detectors) and dose to the assessment of image quality and perception, the development of image processing techniques, and the development of image analysis methods to assist in detection and diagnosis. The latter is a natural extension of medical physicists’ goals in developing imaging techniques to help physicians acquire diagnostic information and improve clinical decisions. Studies indicate that radiologists do not detect all abnormalities on images that are visible on retrospective review, and they do not always correctly characterize abnormalities that are found. Since the 1950s, the potential use of computers had been considered for analysis of radiographic abnormalities. In the mid-1980s, however, medical physicists and radiologists began major research efforts for computer-aided detection or computer-aided diagnosis (CAD), that is, using the computer output as an aid to radiologists—as opposed to a completely automatic computer interpretation—focusing initially on methods for the detection of lesions on chest radiographs and mammograms. Since then, extensive investigations of computerized image analysis for detection or diagnosis of abnormalities in a variety of 2D and 3D medical images have been conducted. The growth of CAD over the past 20 years has been tremendous—from the early days of time-consuming film digitization and CPU-intensive computations on a limited number of cases to its current status in which developed CAD approaches are evaluated rigorously on large clinically relevant databases. CAD research by medical physicists includes many aspects—collecting relevant normal and pathological cases; developing computer algorithms appropriate for the medical interpretation task including those for segmentation, feature extraction, and classifier design; developing methodology for assessing CAD performance; validating the algorithms using appropriate cases to measure performance and robustness; conducting observer studies with which to evaluate radiologists in the diagnostic task without and with the use of the computer aid; and ultimately assessing performance with a clinical trial. Medical physicists also have an important role in quantitative imaging, by validating the quantitative integrity of scanners and developing imaging techniques, and image analysis tools that extract quantitative data in a more accurate and automated fashion. As imaging systems become more complex and the need for better quantitative information from images grows, the future includes the combined research efforts from physicists working in CAD with those working on quantitative imaging systems to readily yield information on morphology, function, molecular structure, and more—from animal imaging research to clinical patient care. A historical review of CAD and a discussion of challenges for the future are presented here, along with the extension to quantitative image analysis. PMID:19175137

Anniversary Paper: History and status of CAD and quantitative image analysis: The role of Medical Physics and AAPM

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

Giger, Maryellen L.; Chan, Heang-Ping; Boone, John

2008-12-15

The roles of physicists in medical imaging have expanded over the years, from the study of imaging systems (sources and detectors) and dose to the assessment of image quality and perception, the development of image processing techniques, and the development of image analysis methods to assist in detection and diagnosis. The latter is a natural extension of medical physicists' goals in developing imaging techniques to help physicians acquire diagnostic information and improve clinical decisions. Studies indicate that radiologists do not detect all abnormalities on images that are visible on retrospective review, and they do not always correctly characterize abnormalities thatmore » are found. Since the 1950s, the potential use of computers had been considered for analysis of radiographic abnormalities. In the mid-1980s, however, medical physicists and radiologists began major research efforts for computer-aided detection or computer-aided diagnosis (CAD), that is, using the computer output as an aid to radiologists--as opposed to a completely automatic computer interpretation--focusing initially on methods for the detection of lesions on chest radiographs and mammograms. Since then, extensive investigations of computerized image analysis for detection or diagnosis of abnormalities in a variety of 2D and 3D medical images have been conducted. The growth of CAD over the past 20 years has been tremendous--from the early days of time-consuming film digitization and CPU-intensive computations on a limited number of cases to its current status in which developed CAD approaches are evaluated rigorously on large clinically relevant databases. CAD research by medical physicists includes many aspects--collecting relevant normal and pathological cases; developing computer algorithms appropriate for the medical interpretation task including those for segmentation, feature extraction, and classifier design; developing methodology for assessing CAD performance; validating the algorithms using appropriate cases to measure performance and robustness; conducting observer studies with which to evaluate radiologists in the diagnostic task without and with the use of the computer aid; and ultimately assessing performance with a clinical trial. Medical physicists also have an important role in quantitative imaging, by validating the quantitative integrity of scanners and developing imaging techniques, and image analysis tools that extract quantitative data in a more accurate and automated fashion. As imaging systems become more complex and the need for better quantitative information from images grows, the future includes the combined research efforts from physicists working in CAD with those working on quantitative imaging systems to readily yield information on morphology, function, molecular structure, and more--from animal imaging research to clinical patient care. A historical review of CAD and a discussion of challenges for the future are presented here, along with the extension to quantitative image analysis.« less

A comparison between findings from the DREEM questionnaire and that from qualitative interviews.

PubMed

Denz-Penhey, Harriet; Murdoch, J Campbell

2009-10-01

The Rural Clinical School of Western Australia educates one quarter of all Western Australian medical students in their first clinical year in rural settings. As part of a comprehensive evaluation programme students give feedback regularly. To identify if the Dundee Ready Education Environment Measurement (DREEM) data could be used qualitatively and descriptively to determine specific problems from the data alone despite the small numbers at some sites. The DREEM questionnaire was administered on the same day as qualitative interviews were undertaken. The qualitative interviews were analysed thematically first and then compared with findings from DREEM. Each major (student related) evaluation issue identified by the qualitative interviews was also identified by the DREEM questionnaire analysis. When the DREEM study was undertaken in the Rural Clinical School of Western Australia there was no real expectation that it would provide sufficient information to identify issues picked up in the extensive and time consuming qualitative study. About half of the work undertaken by the qualitative evaluation, that of the experiences of the students at the site, was picked up by the DREEM questionnaire in a much shorter time frame and at less cost of staff time and resources. The DREEM questionnaire can be used qualitatively to assess very specific issues relating to each of the subscales. These findings extend the use of DREEM from quantitative and statistically significant research to qualitative meaning-filled interpretations. The issues then need to be addressed sensitively.

[Methods for evaluating diagnostic tests in Enfermedades Infecciosas y Microbiología Clínica].

PubMed

Ramos, J M; Hernández, I

1998-04-01

In the field of infectious diseases and clinical microbiology, the evaluation of diagnostic tests (DT) is an important research area. The specific difficulties of this type of research has motivated that have not caught the severity methodological of others areas of clinical research. This article try to asses and characterize the methodology of articles about DT published in Enfermedades Infecciosas y Microbiología Clínica (EIMC) journal. Forty-five articles was selected in the EIMC journal during the 1990-1996 period, because of determinate the sensitivity and specificity of different DT. Methodological standards, extensively accepted was used. In all of articles, except one (98%) the gold standard was specified yours use, however in 4 studies (9%) include the DT in the gold standard (incorporation bias). The correct description of DT was reported in 75% of cases, but only in 11% cases the reproducibility of test was evaluated. The description of source of reference population, standard of inclusion and spectrum of composition was described in 58, 33 and 40% of articles, respectively. In 33% of studies presented workup bias, only 6% commented blind-analysis of results, and 11% presented indeterminate test results. Half of the studies reported test indexes for clinical subgroups, only one article (2%) provided numerical precision for test indexes, and only 7% reported receiver operating characteristics curves. The methodological quality of DT research in the EIMC journal may improve in different aspects of design and presentation of results.

New Focuses on European Extension Education: The Issues. Proceedings of the European Seminar on Extension Education (10th, Vila Real, Portugal, September 1-9, 1991).

ERIC Educational Resources Information Center

Koehnen, Timothy, Ed.; Cristovao, Artur, Ed.

This proceedings report is organized into four sections dealing respectively with: (1) global issues facing extension education; (2) extension strategies and methods; (3) extension planning and evaluation; and (4) training and curriculum development. The following papers are included: "Extension Science: To Broaden the Scope" (van…

Strength and fine dexterity recovery profiles after a primary motor cortex insult and effect of a neuronal cell graft.

PubMed

Vaysse, Laurence; Conchou, Fabrice; Demain, Boris; Davoust, Carole; Plas, Benjamin; Ruggieri, Cyrielle; Benkaddour, Mehdi; Simonetta-Moreau, Marion; Loubinoux, Isabelle

2015-08-01

The aim of this study was to set up (a) a large primary motor cortex (M1) lesion in rodent and (b) the conditions for evaluating a long-lasting motor deficit in order to propose a valid model to test neuronal replacement therapies aimed at improving motor deficit recovery. A mitochondrial toxin, malonate, was injected to induce extensive destruction of the forelimb M1 cortex. Three key motor functions that are usually evaluated following cerebral lesion in the clinic-strength, target reaching, and fine dexterity-were assessed in rats by 2 tests, a forelimb grip strength test and a skilled reaching task (staircase) for reaching and dexterity. The potential enhancement of postlesion recovery induced by a neuronal cell transplantation was then explored and confirmed by histological analyses. Both tests showed a severe functional impairment 2 days post lesion, however, reaching remained intact. Deficits in forelimb strength were long lasting (up to 3 months) but spontaneously recovered despite the extensive lesion size. This natural grip strength recovery could be enhanced by cell therapy. Histological analyses confirmed the presence of grafted cells 3 months postgraft and showed partial tissue reconstruction with some living neuronal cells in the graft. In contrast, fine dexterity never recovered in the staircase test even after grafting. These results suggest that cell replacement was only partially effective and that the forelimb M1 area may be a node of the sensorimotor network, where compensation from secondary pathways could account for strength recovery but recovery of forelimb fine dexterity requires extensive tissue reconstruction. (c) 2015 APA, all rights reserved).

Effects of Volar Tilt, Wrist Extension, and Plate Position on Contact Between Flexor Pollicis Longus Tendon and Volar Plate.

PubMed

Wurtzel, Caroline N Wolfe; Burns, Geoffrey T; Zhu, Andy F; Ozer, Kagan

2017-12-01

Volar plates positioned at, or distal to, the watershed line have been shown to have a higher incidence of attritional rupture of the flexor pollicis longus (FPL). In this study, we aimed to evaluate the effect of wrist extension and volar tilt on the contact between the plate and the FPL tendon in a cadaver model. We hypothesized that, following volar plate application, loss of native volar tilt increases the contact between the FPL and the plate at lower degrees of wrist extension. A volar locking plate was applied on 6 fresh-frozen cadavers. To determine the contact between the plate and the FPL tendon, both structures were wrapped with copper wire and circuit conductivity was monitored throughout wrist motion. A lateral wrist radiograph was obtained at each circuit closure, indicating tendon-plate contact. Baseline measurements were obtained with plate positioned at Soong grades 0, 1, and 2. An extra-articular osteotomy was made and contact was recorded at various volar tilt angles (+5°, 0°, -5°, -10°, -15°, and -20°) in 3 different plate positions. A blinded observer measured the degree of wrist extension on all lateral radiographs. Data were analyzed using linear mixed-effects regression model. Plates placed distal to the watershed line had the most contact throughout wrist range of motion. Significantly, less wrist extension was required for contact in wrists with neutral or dorsal tilt and in distally placed volar plates. Volar tilt, wrist extension, and plate position were 3 independent risk factors determining contact between plate and tendon. Loss of volar tilt, increased wrist extension, and higher Soong grade plate position result in greater contact between wire-wrapped FPL tendon and plate. The FPL/plate contact chart generated in this study may be used to assess the risk of rupture in the clinical setting. Copyright © 2017 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Private Agricultural Extension System in Kenya: Practice and Policy Lessons

ERIC Educational Resources Information Center

Muyanga, Milu; Jayne, T. S.

2008-01-01

Private extension system has been at the centre of a debate triggered by inefficient public agricultural extension. The debate is anchored on the premise that the private sector is more efficient in extension service delivery. This study evaluates the private extension system in Kenya. It employs qualitative and quantitative methods. The results…

Chemotherapy in combination with cytokine-induced killer cell transfusion: An effective therapeutic option for patients with extensive stage small cell lung cancer.

PubMed

Huang, Jianmin; Kan, Quancheng; Lan; Zhao, Xuan; Zhang, Zhen; Yang, Shuangning; Li, Hong; Wang, Liping; Xu, Li; Cheng, Zhe; Zhang, Yi

2017-05-01

In the past decade of clinical studies, the combination of chemotherapy with cytokine induced killer (CIK) cell transfusion has confirmed a promised efficacy in several types of cancer. CIK cells are a mixture of T lymphocytes, generated from peripheral blood mononuclear cells induced by multiple cytokines. This study was aimed to evaluate the clinical efficacy of chemotherapy combined with CIK- cell therapy in patients with extensive stage small cell lung cancer (ES SCLC). Forty four patients with ES SCLC were enrolled in this study. All the patients received treatment from Oct 2010 to Sep 2013 in the First Affiliated Hospital of Zhengzhou University. Included patients were equally divided into 2 groups according to the treatment strategies. Patients in the combined treatment group received chemotherapy combined with CIK-cell transfusion and patients in the control group received chemotherapy alone. The short-term effects, overall survival (OS), progress free survival (PFS) and therapy-related adverse events were analyzed retrospectively. Short-term efficacy evaluation indicated that the total response rates in the combined treatment group and control group were 40.9% (9/22) and 9.1% (2/22), respectively. There was a significant difference between the two groups (p=0.0339). Furthermore, the PFS of the combined treatment group was significantly longer than that of the control group (8 vs. 4months, P=0.005). No severe side effect was observed after transfusion of CIK cells. These results indicated that chemotherapy combined with CIK-cell immunotherapy might provide a safe and effective treatment for patients with ES SCLC. Copyright © 2016. Published by Elsevier B.V.

Retrospective Analysis of 255 Papillary Thyroid Carcinomas ≤2 cm: Clinicohistological Features and Prognostic Factors

PubMed Central

Marques, Pedro; Leite, Valeriano; Bugalho, Maria João

2014-01-01

Background Papillary thyroid carcinoma (PTC) is the most common thyroid cancer. The widespread use of neck ultrasound (US) and US-guided fine-needle aspiration cytology is triggering an overdiagnosis of PTC. Objective To evaluate clinical behavior and outcomes of patients with PTCs ≤2 cm, seeking for possible prognostic factors. Methods Clinical records of cases with histological diagnosis of PTC ≤2 cm followed at the Endocrine Department of Instituto Português de Oncologia, Lisbon between 2002 and 2006 were analyzed retrospectively. Results We identified 255 PTCs, 111 were microcarcinomas. Most patients underwent near-total thyroidectomy, with lymph node dissections in 55 cases (21.6%). Radioiodine therapy was administered in 184 patients. At the last evaluation, 38 (14.9%) had evidence of disease. Two deaths were attributed to PTC. Median (±SD) follow-up was 74 (±23) months. Multivariate analysis identified vascular invasion, lymph node and systemic metastases significantly associated with recurrence/persistence of disease. In addition, lymph node involvement was significantly associated with extrathyroidal extension and angioinvasion. Median (±SD) disease-free survival (DFS) was estimated as 106 (±3) months and the 5-year DFS rate was 87.5%. Univariate Cox analysis identified some relevant parameters for DFS, but multivariate regression only identified lymph node and systemic metastases as significant independent factors. The median DFS estimated for lymph node and systemic metastases was 75 and 0 months, respectively. Conclusions In the setting of small PTCs, vascular invasion, extrathyroidal extension and lymph node and/or systemic metastases may confer worse prognosis, perhaps justifying more aggressive therapeutic and follow-up approaches in such cases. PMID:25759803

Future therapeutic directions for factor Xa inhibition in the prophylaxis and treatment of thrombotic disorders.

PubMed

Turpie, Alexander G G

2003-11-15

The targeted mechanism of factor Xa inhibition has been studied extensively, initially as prophylaxis for venous thromboembolism (VTE) in the orthopedic surgical setting. Future therapeutic directions for selective factor Xa inhibition in the management of other thrombotic diseases are discussed. Thromboembolic diseases can occur in the venous or arterial sides of the circulatory system. Factor Xa inhibition is a targeted approach to anticoagulation that resulted from significant advances in our understanding of the coagulation cascade. The factor Xa inhibitor fondaparinux has been studied extensively in the orthopedic surgical setting for the prophylaxis of VTE. Current investigations that are under way or completed evaluate the efficacy and safety of fondaparinux for the management of various thrombotic diseases. The future development of fondaparinux resides primarily in three therapeutic areas: prevention of VTE, treatment of VTE, and treatment of acute coronary syndromes. For the prevention of VTE, fondaparinux has been studied as extended prophylaxis following hip fracture surgery (PENTHIFRA Plus), for use in high-risk abdominal surgical patients (PEGASUS and APOLLO), and for use in medical patients (ARTEMIS). Studies evaluating fondaparinux for the treatment of VTE are part of the large MATISSE clinical program (MATISSE DVT and MATISSE PE). Fondaparinux was investigated in phase 2 studies for the treatment of acute coronary syndromes, including acute ST-segment myocardial infarction (PENTALYSE) and unstable angina (PENTUA). Encouraging data from these trials are the basis for phase 3 programs in this area (MICHELANGELO). The orthopedic prophylactic and nonorthopedic clinical programs for fondaparinux in the management of thrombosis support the concept that targeted inhibition of coagulation is an effective advance in antithrombotic therapy.

Deconstructing tolerance with clobazam

PubMed Central

Wechsler, Robert T.; Sankar, Raman; Montouris, Georgia D.; White, H. Steve; Cloyd, James C.; Kane, Mary Clare; Peng, Guangbin; Tworek, David M.; Shen, Vivienne; Isojarvi, Jouko

2016-01-01

Objective: To evaluate potential development of tolerance to adjunctive clobazam in patients with Lennox-Gastaut syndrome. Methods: Eligible patients enrolled in open-label extension study OV-1004, which continued until clobazam was commercially available in the United States or for a maximum of 2 years outside the United States. Enrolled patients started at 0.5 mg·kg−1·d−1 clobazam, not to exceed 40 mg/d. After 48 hours, dosages could be adjusted up to 2.0 mg·kg−1·d−1 (maximum 80 mg/d) on the basis of efficacy and tolerability. Post hoc analyses evaluated mean dosages and drop-seizure rates for the first 2 years of the open-label extension based on responder categories and baseline seizure quartiles in OV-1012. Individual patient listings were reviewed for dosage increases ≥40% and increasing seizure rates. Results: Data from 200 patients were included. For patients free of drop seizures, there was no notable change in dosage over 24 months. For responder groups still exhibiting drop seizures, dosages were increased. Weekly drop-seizure rates for 100% and ≥75% responders demonstrated a consistent response over time. Few patients had a dosage increase ≥40% associated with an increase in seizure rates. Conclusions: Two-year findings suggest that the majority of patients do not develop tolerance to the antiseizure actions of clobazam. Observed dosage increases may reflect best efforts to achieve seizure freedom. It is possible that the clinical development of tolerance to clobazam has been overstated. ClinicalTrials.gov identifier: NCT00518713 and NCT01160770. Classification of evidence: This study provides Class III evidence that the majority of patients do not develop tolerance to clobazam over 2 years of treatment. PMID:27683846

Periodontal soft tissue root coverage procedures: a systematic review from the AAP Regeneration Workshop.

PubMed

Chambrone, Leandro; Tatakis, Dimitris N

2015-02-01

This paper aims to create a "bridge" between research and practice by developing a practical, extensive, and clinically relevant study that translates evidence-based findings on soft tissue root coverage (RC) of recession-type defects to daily clinical practice. This review is prepared in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) statement based on the proposed focused questions. A literature search with no restrictions regarding status or the language of publication was performed for MEDLINE and EMBASE databases up to and including June 2013. Systematic reviews (SRs), randomized clinical trials, controlled clinical trials, case series, and case reports evaluating recession areas that were treated by means of RC procedures were considered eligible for inclusion through the three parts of the study (part I, an overview of the base of SRs; part II, an alternative random-effects meta-analyses on mean percentage of RC and sites exhibiting complete RC; and part III, an SR of non-randomized trials exploring other conditions not extensively evaluated by previous SRs). Data on Class I, II, III, and IV recessions, type of histologic attachment achieved with treatment, recipient- and donor-site anatomic characteristics, smoking-related outcomes, root surface conditions, tooth type and location, long-term effectiveness outcomes, unusual conditions that may be reported during conventional daily practice, and patient-centered outcomes were assessed as well. Of the 2,456 potentially eligible trials, 234 were included. Data on Class I, II, III, and IV gingival recessions, histologic attachment achieved after treatment, recipient- and donor-site anatomic characteristics, smoking-related outcomes, root surface conditions/biomodification, tooth type and location, long-term effectiveness outcomes and unusual conditions that may be reported during conventional daily practice, and patient-centered outcomes (i.e., esthetic, visual analog scale, complications, hypersensitivity, patients perceptions) were assessed. Subepithelial connective tissue (CT)-based procedures and coronally advanced flap plus acellular dermal matrix grafts, enamel matrix derivative, or collagen matrix led to the best improvements of recession depth, clinical attachment level (CAL) gain, and keratinized tissue (KT). Some conditions, such as smoking and use of magnification, may affect RC outcomes. All RC procedures can provide significant reduction in recession depth and CAL gain for Miller Class I and II recession-type defects. Subepithelial CT graft-based procedures provided the best outcomes for clinical practice because of their superior percentages of mean and complete RC, as well as significant increase of KT.

Assessment of masticatory performance by means of a color-changeable chewing gum.

PubMed

Tarkowska, Agnieszka; Katzer, Lukasz; Ahlers, Marcus Oliver

2017-01-01

Previous research determined the relevance of masticatory performance with regard to nutritional status, cognitive functions, or stress management. In addition, the measurement of masticatory efficiency contributes to the evaluation of therapeutic successes within the stomatognathic system. However, the question remains unanswered as to what extent modern techniques are able to reproduce the subtle differences in masticatory efficiency within various patient groups. The purpose of this review is to provide an extensive summary of the evaluation of masticatory performance by means of a color-changeable chewing gum with regard to its clinical relevance and applicability. A general overview describing the various methods available for this task has already been published. This review focuses in depth on the research findings available on the technique of measuring masticatory performance by means of color-changeable chewing gum. Described are the mechanism and the differentiability of the color change and methods to evaluate the color changes. Subsequently, research on masticatory performance is conducted with regard to patient age groups, the impact of general diseases and the effect of prosthetic and surgical treatment. The studies indicate that color-changeable chewing gum is a valid and reliable method for the evaluation of masticatory function. Apart from other methods, in clinical practice this technique can enhance dental diagnostics as well as the assessment of therapy outcomes. Copyright © 2016 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

[Implementation of a new electronic patient record in surgery].

PubMed

Eggli, S; Holm, J

2001-12-01

The increasing amount of clinical data, intensified interest of patients in medical information, medical quality management and the recent cost explosion in health care systems have forced medical institutions to improve their strategy in handling medical data. In the orthopedic department (3,600 surgeries, 75 beds, 14,000 consultations) software application for comprehensive patient data management has been developed. When implementing the electronic patient history following criteria were evaluated: 1. software evaluation, 2. implementation, 3. work flow, 4. data security/system stability. In the first phase the functional character was defined. Implementation required 3 months after parametrization. The expense amounted to 130,000 DM (30 clients). The training requirements were one afternoon for the secretaries and a 2-h session for the residents. The access speed on medically relevant data averaged under 3 s. The average saving in working hours was approximately 5 h/week for the secretaries and 4 h/week for the residents. The saving in paper amounted to 36,000 sheets/year. In 3 operational years there were 3 server breakdowns. Evaluation of the saving on working hours showed that such a system can amortize within a year. The latest improvements in hardware and software technology made the electronic medical record with integrated quality-control practicable without massive expenditure. The system supplies an extensive platform of information for patient treatment and an instrument to evaluate the efficiency of therapy strategies independent of the clinical field.

Structurally simplified biphenyl combretastatin A4 derivatives retain in vitro anti-cancer activity dependent on mitotic arrest

PubMed Central

Tarade, Daniel; Ma, Dennis; Pignanelli, Christopher; Mansour, Fadi; Simard, Daniel; van den Berg, Sean; Gauld, James; McNulty, James; Pandey, Siyaram

2017-01-01

The cis-stilbene, combretastatin A4 (CA4), is a potent microtubule targeting and vascular damaging agent. Despite promising results at the pre-clinical level and extensive clinical evaluation, CA4 has yet to be approved for therapeutic use. One impediment to the development of CA4 is an inherent conformational instability about the ethylene linker, which joins two aromatic rings. We have previously published preliminary data regarding structurally simplified biphenyl derivatives of CA4, lacking an ethylene linker, which retain anti-proliferative and pro-apoptotic activity, albeit at higher doses. Our current study provides a more comprehensive evaluation regarding the anti-proliferative and pro-apoptotic properties of biphenyl CA4 derivatives in both 2D and 3D cancerous and non-cancerous cell models. Computational analysis has revealed that cytotoxicity of CA4 and biphenyl analogues correlates with predicted tubulin affinity. Additional mechanistic evaluation of the biphenyl derivatives found that their anti-cancer activity is dependent on prolonged mitotic arrest, in a similar manner to CA4. Lastly, we have shown that cancer cells deficient in the extrinsic pathway of apoptosis experience delayed cell death following treatment with CA4 or analogues. Biphenyl derivatives of CA4 represent structurally simplified analogues of CA4, which retain a similar mechanism of action. The biphenyl analogues warrant in vivo examination to evaluate their potential as vascular damaging agents. PMID:28253265

Evaluating Contextual Processing in Diffusion MRI: Application to Optic Radiation Reconstruction for Epilepsy Surgery

PubMed Central

Tax, Chantal M. W.; Duits, Remco; Vilanova, Anna; ter Haar Romeny, Bart M.; Hofman, Paul; Wagner, Louis; Leemans, Alexander; Ossenblok, Pauly

2014-01-01

Diffusion MRI and tractography allow for investigation of the architectural configuration of white matter in vivo, offering new avenues for applications like presurgical planning. Despite the promising outlook, there are many pitfalls that complicate its use for (clinical) application. Amongst these are inaccuracies in the geometry of the diffusion profiles on which tractography is based, and poor alignment with neighboring profiles. Recently developed contextual processing techniques, including enhancement and well-posed geometric sharpening, have shown to result in sharper and better aligned diffusion profiles. However, the research that has been conducted up to now is mainly of theoretical nature, and so far these techniques have only been evaluated by visual inspection of the diffusion profiles. In this work, the method is evaluated in a clinically relevant application: the reconstruction of the optic radiation for epilepsy surgery. For this evaluation we have developed a framework in which we incorporate a novel scoring procedure for individual pathways. We demonstrate that, using enhancement and sharpening, the extraction of an anatomically plausible reconstruction of the optic radiation from a large amount of probabilistic pathways is greatly improved in three healthy controls, where currently used methods fail to do so. Furthermore, challenging reconstructions of the optic radiation in three epilepsy surgery candidates with extensive brain lesions demonstrate that it is beneficial to integrate these methods in surgical planning. PMID:25077946

Clinical validation of 3 commercial real-time reverse transcriptase polymerase chain reaction assays for the detection of Middle East respiratory syndrome coronavirus from upper respiratory tract specimens.

PubMed

Mohamed, Deqa H; AlHetheel, AbdulKarim F; Mohamud, Hanat S; Aldosari, Kamel; Alzamil, Fahad A; Somily, Ali M

2017-04-01

Since discovery of Middle East respiratory syndrome coronavirus (MERS-CoV), a novel betacoronavirus first isolated and characterized in 2012, MERS-CoV real-time reverse transcriptase polymerase chain reaction (rRT-PCR) assays represent one of the most rapidly expanding commercial tests. However, in the absence of extensive evaluations of these assays on positive clinical material of different sources, evaluating their diagnostic effectiveness remains challenging. We describe the diagnostic performance evaluation of 3 common commercial MERS-CoV rRT-PCR assays on a large panel (n = 234) of upper respiratory tract specimens collected during an outbreak episode in Saudi Arabia. Assays were compared to the RealStar® MERS-CoV RT-PCR (Alton Diagnostics, Hamburg, Germany) assay as the gold standard. Results showed i) the TIB MolBiol® LightMix UpE and Orf1a assays (TIB MolBiol, Berlin, Germany) to be the most sensitive, followed by ii) the Anyplex™ Seegene MERS-CoV assay (Seegene, Seoul, Korea), and finally iii) the PrimerDesign™ Genesig® HCoV_2012 assay (PrimerDesign, England, United Kingdom). We also evaluate a modified protocol for the PrimerDesign™ Genesig® HCoV_2012 assay. Copyright © 2017 Elsevier Inc. All rights reserved.

Evaluating contextual processing in diffusion MRI: application to optic radiation reconstruction for epilepsy surgery.

PubMed

Tax, Chantal M W; Duits, Remco; Vilanova, Anna; ter Haar Romeny, Bart M; Hofman, Paul; Wagner, Louis; Leemans, Alexander; Ossenblok, Pauly

2014-01-01

Diffusion MRI and tractography allow for investigation of the architectural configuration of white matter in vivo, offering new avenues for applications like presurgical planning. Despite the promising outlook, there are many pitfalls that complicate its use for (clinical) application. Amongst these are inaccuracies in the geometry of the diffusion profiles on which tractography is based, and poor alignment with neighboring profiles. Recently developed contextual processing techniques, including enhancement and well-posed geometric sharpening, have shown to result in sharper and better aligned diffusion profiles. However, the research that has been conducted up to now is mainly of theoretical nature, and so far these techniques have only been evaluated by visual inspection of the diffusion profiles. In this work, the method is evaluated in a clinically relevant application: the reconstruction of the optic radiation for epilepsy surgery. For this evaluation we have developed a framework in which we incorporate a novel scoring procedure for individual pathways. We demonstrate that, using enhancement and sharpening, the extraction of an anatomically plausible reconstruction of the optic radiation from a large amount of probabilistic pathways is greatly improved in three healthy controls, where currently used methods fail to do so. Furthermore, challenging reconstructions of the optic radiation in three epilepsy surgery candidates with extensive brain lesions demonstrate that it is beneficial to integrate these methods in surgical planning.

Dental erosion caused by gastroesophageal reflux disease: a case report

PubMed Central

Cengiz, M İnanç; Saraç, Y Şinasi

2009-01-01

Introduction Chronic regurgitation of gastric acids in patients with gastroesophageal reflux disease may cause dental erosion, which can lead in combination with attrition or bruxism to extensive loss of coronal tooth tissue. Case presentation This clinical report describes treatment of severe tooth wear of a gastroesophageal reflux disease patient who is 54-year-old Turkish male patient. After his medical treatment, severe tooth wear, bruxism and decreased vertical dimensions were determined. The vertical dimension was re-established and maxillary and mandibular anterior and posterior teeth were prepared for metal-ceramic restorations. Metal-ceramic fixed partial dentures were fabricated as full mouth restorations for both maxillary and mandibular arches because of splinting all teeth. And then maxillary stabilization splint was fabricated for his bruxism history. Conclusion Significant loss of coronal tooth structure must taken into consideration. Gastroesophageal reflux disease by itself or in combination with attrition, abrasion or bruxism may be responsible for the loss. An extensive diagnostic evaluation is essential for the medical and dental effects of the problem. PMID:19830044

Photogrammetric registration of dental plaque accumulation in vivo.

PubMed

Bergström, J

1981-01-01

Using the labial surface of upper anterior laterals for determination, the accumulation of plaque was assessed by means of a stereo-photogrammetric method. The stereoimages were subjected to photogrammetric evaluation, the part of the surface area covered by plaque being given in per cent of the total surface area of the tooth. Plaque extension and plaque topography was studied in young adults with healthy periodontia during a 20 day period of no oral hygiene. At the end of the experimental period, on an average 75 per cent of the surface area was covered by plaque, corresponding to an extension rate of 3.75 per cent per day. The correlation between plaque values obtained by photogrammetry and various estimates obtained from clinical scoring ranged between r = 0.66 and r = 0.78. It is concluded that the method introduced is a sensitive means of determining small amounts of plaque and should prove useful for in vivo investigation of plaque growth and plaque suppression, where measurements of high quality is of importance.

Dental erosion caused by gastroesophageal reflux disease: a case report.

PubMed

Cengiz, Seda; Cengiz, M Inanç; Saraç, Y Sinasi

2009-07-22

Chronic regurgitation of gastric acids in patients with gastroesophageal reflux disease may cause dental erosion, which can lead in combination with attrition or bruxism to extensive loss of coronal tooth tissue. This clinical report describes treatment of severe tooth wear of a gastroesophageal reflux disease patient who is 54-year-old Turkish male patient. After his medical treatment, severe tooth wear, bruxism and decreased vertical dimensions were determined. The vertical dimension was re-established and maxillary and mandibular anterior and posterior teeth were prepared for metal-ceramic restorations. Metal-ceramic fixed partial dentures were fabricated as full mouth restorations for both maxillary and mandibular arches because of splinting all teeth. And then maxillary stabilization splint was fabricated for his bruxism history. Significant loss of coronal tooth structure must taken into consideration. Gastroesophageal reflux disease by itself or in combination with attrition, abrasion or bruxism may be responsible for the loss. An extensive diagnostic evaluation is essential for the medical and dental effects of the problem.

Postural and Intention Tremors: A Detailed Clinical Study of Essential Tremor vs. Parkinson’s Disease

PubMed Central

Sternberg, Eliezer J.; Alcalay, Roy N.; Levy, Oren A.; Louis, Elan D.

2013-01-01

Background: An estimated 30–50% of essential tremor (ET) diagnoses are incorrect, and the true diagnosis in those patients is often Parkinson’s disease (PD) or other tremor disorders. There are general statements about the tremor in these ET and PD, but published data on the more subtle characteristics of tremor are surprisingly limited. Postural tremor may occur in both disorders, adding to the difficulty. There are several anecdotal impressions regarding specific features of postural tremor in ET vs. PD, including joint distribution (e.g., phalanges, metacarpal-phalangeal joints, wrist), tremor directionality (e.g., flexion-extension vs. pronation-supination), and presence of intention tremor. However, there is little data to support these impressions. Methods: In this cross-sectional study, 100 patients (ET, 50 PD) underwent detailed videotaped neurological examinations. Arm tremor was rated by a movement disorder neurologist who assessed severity and directionality across multiple joints. Results: During sustained arm extension, ET patients exhibited more wrist than metacarpal-phalangeal and phalangeal joint tremor than did PD patients (p < 0.001), and more wrist flexion-extension tremor than wrist pronation-supination tremor (p < 0.001). During the finger-nose-finger maneuver, intention tremor was present in approximately one in four (28%) ET patients vs. virtually none (4%) of the Parkinson’s patients (p < 0.001). Conclusions: We evaluated the location, severity, and directionality of postural tremor in ET and PD, and the presence of intention tremor, observing several clinical differences. We hope that detailed phenomenological data on tremor in ET and PD will help practicing physicians delineate the two diseases. PMID:23717300

Increase of cortical bone after a cementless long stem in periprosthetic fractures.

PubMed

García-Rey, Eduardo; García-Cimbrelo, Eduardo; Cruz-Pardos, Ana; Madero, Rosário

2013-12-01

Healing and functional recovery have been reported using an extensively porous-coated stem in Vancouver B2 and B3 periprosthetic fractures; however, loss of cortical bone has been observed when using these stems in revision surgery for aseptic loosening. However, it is unclear whether this bone loss influences subsequent loosening. We analyze the healing fracture rate and whether the radiographic changes observed around and extensively porous-coated stem used for periprosthetic fractures affect function or loosening. We retrospectively reviewed 35 patients with periprosthetic fractures (20 Vancouver B2 and 15 Vancouver B3). Patients' mean age at surgery was 80 years (range, 51-86 years). No cortical struts were used in this series. We evaluated radiographs for signs of loosening or subsidence. The cortical index and the femoral cortical width were measured at different levels on the immediate pre- and postoperative radiographs and at different periods of followup. The minimum followup was 3 years (mean, 8.3 years; range, 3-17 years). All fractures had healed, and all stems were clinically and radiographically stable at the end of followup. Nineteen hips showed nonprogressive radiographic subsidence during the first 3 postoperative months without clinical consequences. The cortical index and the lateral and medial cortical thickness increased over time. Increase of femoral cortex thicknesses was greater in cases with moderate preoperative osteoporosis and in cases with stems less than 16 mm in thickness. Our data suggest an extensively porous-coated stem for Vancouver B2 and B3 periprosthetic fractures leads to a high rate of union and stable fixation. Cortical index and lateral cortex thickness increased in these patients with periprosthetic fractures. Patients with moderate osteoporosis and those using thin stems showed a major increase in femoral cortex thickness over time.

Sinonasal papillomas in a private referral otorhinolaryngology centre: Review of 22 years experience.

PubMed

de Sousa Fontes, Aderito; Sandrea Jiménez, Minaret; Urdaneta Lafée, Nelson; Abreu Durán, Perfecto A; Quintana Páez, Liwven E; de Sousa de Abreu, Andreina Carmina

To evaluate the clinical presentation, treatment outcome and follow-up of all patients managed with sinonasal papillomas (SP), at a tertiary private otorhinolaryngology centre in Caracas (Venezuela). We reviewed 94 patients with SP that were treated at our otolaryngology center, from July 1st 1993 to June 31st 2015. The demographic data, clinical features, radiological findings, anatomical origin, disease extension into the adjacent structures, surgical approaches performed, histopathology outcomes, recurrent risk, malignant transformation rate and coadjuvant therapies were assessed. Sixty-five patients (69.1%) were male and 29 (30.9%) female with an average age of 44.5 years (range 9-80 years). All patients underwent endoscopic sinus surgery. The most commont histologic subtypes of SP were inverted papilloma (58 patients; 61.7%), fungiform papilloma (35 patients; 37.2%) and oncocytic papilloma (one patient; 1.1%). SP was associated in 2 patients with undifferentiated squamous cell carcinoma. Twelve patients (12.8%) had disease with extension beyond the sinus without associated malignancy. All these patients received adjuvant treatment with advanced techniques of radiotherapy. The mean duration of the follow-up period was 9 years and 2 months. Eighteen patients (19.1%) had recurrent disease during the entire course of follow-up. Complete endoscopic surgical removal of SP is the treatment of choice. In less endoscopically accessible tumours, with peripheral extension or incompletely resected, Intensity Modulated Radiotherapy and Volumetric Modulated Arc Therapy may be indicated. Timely post-operative endoscopic follow-up with biopsy of suspected lesions is important for early detection of recurrences and associated malignancy. Copyright © 2016 Elsevier España, S.L.U. and Sociedad Española de Otorrinolaringología y Cirugía de Cabeza y Cuello. All rights reserved.

Strokectomy and Extensive Cerebrospinal Fluid Drainage for the Treatment of Space-Occupying Cerebellar Ischemic Stroke.

PubMed

Tartara, Fulvio; Bongetta, Daniele; Colombo, Elena Virginia; Bortolotti, Carlo; Cenzato, Marco; Giombelli, Ermanno; Gaetani, Paolo; Zenga, Francesco; Pilloni, Giulia; Ciccone, Alfonso; Sessa, Maria

2018-04-03

Cerebellar ischemia may lead to space-occupying edema, resulting in potentially fatal complications. Different surgical procedures are available to create space for the swollen ischemic brain; however, the type and timing of surgical treatments remain topics of debate in the literature. Here we report a case series of patients treated with a unilateral craniotomy to perform a cerebellar strokectomy and extensive cerebrospinal fluid (CSF) drainage without osteodural posterior fossa decompression. We retrospectively analyzed the clinical and radiographic data of 11 patients with posterior fossa ischemia who underwent surgery at one of our institutions. A statistical analysis was performed to identify potential predictive factors for functional outcome. The mean patient age was 64.7 years. The involved vascular territory was the Posterior inferior cerebellar artery in 9 patients (82%) and the anterior inferior cerebellar artery/superior cerebellar artery in 2 patients (18%). The mean Glasgow Coma Scale score was 13.6 on admission, but 9.3 immediately before surgery. The surgical procedure was performed in a mean of 36.8 minutes after the radiologic diagnosis of space-occupying edema. Clinical outcome at 6 months was good (modified Rankin Scale [mRS] score ≤2) in 9 patients (82%). Surgery-related complications occurred in 2 patients (18%), and these was a single death (9%) not related to the procedure or posterior fossa compression. Matching patients with their mRS outcome evaluation, the sole variable significantly associated with good outcome was age at admission (62.1 vs. 76.5 years; P < 0.05). Unilateral suboccipital craniotomy with strokectomy and extensive CSF drainage may allow for satisfactory decompression of the ischemic posterior fossa with acceptable morbidity and mortality rates, especially in younger patients. Copyright © 2018 Elsevier Inc. All rights reserved.

Increasing Complexity in Rule-Based Clinical Decision Support: The Symptom Assessment and Management Intervention.

PubMed

Lobach, David F; Johns, Ellis B; Halpenny, Barbara; Saunders, Toni-Ann; Brzozowski, Jane; Del Fiol, Guilherme; Berry, Donna L; Braun, Ilana M; Finn, Kathleen; Wolfe, Joanne; Abrahm, Janet L; Cooley, Mary E

2016-11-08

Management of uncontrolled symptoms is an important component of quality cancer care. Clinical guidelines are available for optimal symptom management, but are not often integrated into the front lines of care. The use of clinical decision support (CDS) at the point-of-care is an innovative way to incorporate guideline-based symptom management into routine cancer care. The objective of this study was to develop and evaluate a rule-based CDS system to enable management of multiple symptoms in lung cancer patients at the point-of-care. This study was conducted in three phases involving a formative evaluation, a system evaluation, and a contextual evaluation of clinical use. In Phase 1, we conducted iterative usability testing of user interface prototypes with patients and health care providers (HCPs) in two thoracic oncology clinics. In Phase 2, we programmed complex algorithms derived from clinical practice guidelines into a rules engine that used Web services to communicate with the end-user application. Unit testing of algorithms was conducted using a stack-traversal tree-spanning methodology to identify all possible permutations of pathways through each algorithm, to validate accuracy. In Phase 3, we evaluated clinical use of the system among patients and HCPs in the two clinics via observations, structured interviews, and questionnaires. In Phase 1, 13 patients and 5 HCPs engaged in two rounds of formative testing, and suggested improvements leading to revisions until overall usability scores met a priori benchmarks. In Phase 2, symptom management algorithms contained between 29 and 1425 decision nodes, resulting in 19 to 3194 unique pathways per algorithm. Unit testing required 240 person-hours, and integration testing required 40 person-hours. In Phase 3, both patients and HCPs found the system usable and acceptable, and offered suggestions for improvements. A rule-based CDS system for complex symptom management was systematically developed and tested. The complexity of the algorithms required extensive development and innovative testing. The Web service-based approach allowed remote access to CDS knowledge, and could enable scaling and sharing of this knowledge to accelerate availability, and reduce duplication of effort. Patients and HCPs found the system to be usable and useful. ©David F Lobach, Ellis B Johns, Barbara Halpenny, Toni-Ann Saunders, Jane Brzozowski, Guilherme Del Fiol, Donna L Berry, Ilana M Braun, Kathleen Finn, Joanne Wolfe, Janet L Abrahm, Mary E Cooley. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 08.11.2016.

Efficacy and Safety of Ixekizumab in Patients with Active Psoriatic Arthritis: 52-week Results from a Phase III Study (SPIRIT-P1).

PubMed

van der Heijde, Désirée; Gladman, Dafna D; Kishimoto, Mitsumasa; Okada, Masato; Rathmann, Suchitrita S; Moriarty, Susan R; Shuler, Catherine L; Carlier, Hilde; Benichou, Olivier; Mease, Philip J

2018-03-01

To evaluate the efficacy and safety of ixekizumab (IXE), an interleukin 17A antagonist, in patients with psoriatic arthritis (PsA) after 52 weeks in a phase III study. Patients were initially randomly assigned to IXE 80 mg every 2 weeks (IXEQ2W) or every 4 weeks (IXEQ4W) after a 160-mg starting dose, placebo (PBO), or adalimumab (ADA) 40 mg Q2W. At Week 24 (Week 16 for inadequate responders), ADA (8-week washout before starting IXE) and PBO patients were rerandomized to IXEQ2W or IXEQ4W. Six treatment groups were evaluated in the extension period (weeks 24-52): IXEQ2W/IXEQ2W, IXEQ4W/IXEQ4W, ADA/IXEQ2W, ADA/IXEQ4W, PBO/IXEQ2W, and PBO/IXEQ4W. The extension period population (EPP) included patients who received ≥ 1 dose of study medication during the extension period. There were 381/417 (91.4%) patients who entered the extension period. In the IXEQ4W/IXEQ4W and IXEQ2W/IXEQ2W groups (EPP), respectively, American College of Rheumatology (ACR)20 (69.1% and 68.8%), ACR50 (54.6% and 53.1%), and ACR70 (39.2% and 39.6%) response rates were sustained at Week 52. Patients rerandomized to IXE also demonstrated efficacy measured by ACR response rates at Week 52. A similar pattern was observed for Psoriasis Area and Severity Index outcomes. Radiographic progression in all 6 groups was minimal. The most frequently reported treatment-emergent adverse events (≥ 4%) were nasopharyngitis, injection site reaction, injection site erythema, upper respiratory tract infection, and back pain. No deaths were reported, and serious adverse event frequency was 0-4% with IXE. During the extension period, IXEQ4W or IXEQ2W treatment demonstrated sustained efficacy in key PsA domains with a safety profile consistent with other studies investigating IXE. Clinical trial number: NCT01695239; EudraCT 2011-002326-49.

Evaluating the Impact of Cooperative Extension Outreach via Twitter

ERIC Educational Resources Information Center

O'Neill, Barbara

2014-01-01

Twitter is increasingly being used by Extension educators as a teaching and program-marketing tool. It is not enough, however, to simply use Twitter to disseminate information. Steps must be taken to evaluate program impact with quantitative and qualitative data. This article described the following Twitter evaluation metrics: unique hashtags,…

Extensive Evaluation of Using a Game Project in a Software Architecture Course

ERIC Educational Resources Information Center

Wang, Alf Inge

2011-01-01

This article describes an extensive evaluation of introducing a game project to a software architecture course. In this project, university students have to construct and design a type of software architecture, evaluate the architecture, implement an application based on the architecture, and test this implementation. In previous years, the domain…

Pasireotide can induce sustained decreases in urinary cortisol and provide clinical benefit in patients with Cushing's disease: results from an open-ended, open-label extension trial.

PubMed

Schopohl, Jochen; Gu, Feng; Rubens, Robert; Van Gaal, Luc; Bertherat, Jérôme; Ligueros-Saylan, Monica; Trovato, Andrew; Hughes, Gareth; Salgado, Luiz R; Boscaro, Marco; Pivonello, Rosario

2015-10-01

Report the efficacy and safety of pasireotide sc in patients with Cushing's disease during an open-ended, open-label extension to a randomized, double-blind, 12-month, Phase III study. 162 patients entered the core study. 58 patients who had mean UFC ≤ ULN at month 12 or were benefiting clinically from pasireotide entered the extension. Patients received the same dose of pasireotide as at the end of the core study (300-1,200 μg bid). Dose titration was permitted according to efficacy or drug-related adverse events. 40 patients completed 24 months' treatment. Of the patients who entered the extension, 50.0% (29/58) and 34.5% (20/58) had controlled UFC (UFC ≤ ULN) at months 12 and 24, respectively. The mean percentage decrease in UFC was 57.3% (95% CI 40.7-73.9; n = 52) and 62.1% (50.8-73.5; n = 33) after 12 and 24 months' treatment, respectively. Improvements in clinical signs of Cushing's disease were sustained up to month 24. The most frequent drug-related adverse events in patients who received ≥1 dose of pasireotide (n = 162) from core baseline until the 24-month cut-off were diarrhea (55.6%), nausea (48.1%), hyperglycemia (38.9%), and cholelithiasis (31.5%). No new safety issues were identified during the extension. Reductions in mean UFC and improvements in clinical signs of Cushing's disease were maintained over 24 months of pasireotide treatment. The safety profile of pasireotide is typical for a somatostatin analogue, except for the frequency and degree of hyperglycemia; patients should be monitored for changes in glucose homeostasis. Pasireotide represents the first approved pituitary-targeted treatment for patients with Cushing's disease.

Improving validation methods for molecular diagnostics: application of Bland-Altman, Deming and simple linear regression analyses in assay comparison and evaluation for next-generation sequencing.

PubMed

Misyura, Maksym; Sukhai, Mahadeo A; Kulasignam, Vathany; Zhang, Tong; Kamel-Reid, Suzanne; Stockley, Tracy L

2018-02-01

A standard approach in test evaluation is to compare results of the assay in validation to results from previously validated methods. For quantitative molecular diagnostic assays, comparison of test values is often performed using simple linear regression and the coefficient of determination (R 2 ), using R 2 as the primary metric of assay agreement. However, the use of R 2 alone does not adequately quantify constant or proportional errors required for optimal test evaluation. More extensive statistical approaches, such as Bland-Altman and expanded interpretation of linear regression methods, can be used to more thoroughly compare data from quantitative molecular assays. We present the application of Bland-Altman and linear regression statistical methods to evaluate quantitative outputs from next-generation sequencing assays (NGS). NGS-derived data sets from assay validation experiments were used to demonstrate the utility of the statistical methods. Both Bland-Altman and linear regression were able to detect the presence and magnitude of constant and proportional error in quantitative values of NGS data. Deming linear regression was used in the context of assay comparison studies, while simple linear regression was used to analyse serial dilution data. Bland-Altman statistical approach was also adapted to quantify assay accuracy, including constant and proportional errors, and precision where theoretical and empirical values were known. The complementary application of the statistical methods described in this manuscript enables more extensive evaluation of performance characteristics of quantitative molecular assays, prior to implementation in the clinical molecular laboratory. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

The Society for Translational Medicine: clinical practice guidelines for sperm DNA fragmentation testing in male infertility

PubMed Central

Cho, Chak-Lam; Majzoub, Ahmad; Esteves, Sandro C.

2017-01-01

Sperm DNA fragmentation (SDF) testing has been emerging as a valuable tool for male fertility evaluation. While the essential role of sperm DNA integrity in human reproduction was extensively studied, the clinical indication of SDF testing is less clear. This clinical practice guideline provides recommendations of clinical utility of the test supported by evidence. It is intended to serve as a reference for fertility specialists in identifying the circumstances in which SDF testing should be of greatest clinical value. SDF testing is recommended in patients with clinical varicocele and borderline to normal semen parameters as it can better select varicocelectomy candidates. Outcomes of natural pregnancy and assisted reproductive techniques (ART) can be predicted by result of SDF tests. High SDF is also linked with recurrent pregnancy loss (RPL) and failure of ART. Result of SDF testing may change the management decision by selecting the most appropriate ART with the highest success rate for infertile couples. Several studies have demonstrated the benefit in using testicular instead of ejaculated sperm in men with high SDF, oligozoospermia or recurrent in vitro fertilization (IVF) failure. Infertile men with modifiable lifestyle factor may benefit from SDF testing by reinforcing risk factor modification and monitoring patient’s progress to intervention. PMID:29082206

Validation of the Novaco Anger Scale-Provocation Inventory (Danish) With Nonclinical, Clinical, and Offender Samples.

PubMed

Moeller, Stine Bjerrum; Novaco, Raymond W; Heinola-Nielsen, Vivian; Hougaard, Helle

2016-10-01

Anger has high prevalence in clinical and forensic settings, and it is associated with aggressive behavior and ward atmosphere on psychiatric units. Dysregulated anger is a clinical problem in Danish mental health care systems, but no anger assessment instruments have been validated in Danish. Because the Novaco Anger Scale and Provocation Inventory (NAS-PI) has been extensively validated with different clinical populations and lends itself to clinical case formulation, it was selected for translation and evaluation in the present multistudy project. Psychometric properties of the NAS-PI were investigated with samples of 477 nonclinical, 250 clinical, 167 male prisoner, and 64 male forensic participants. Anger prevalence and its relationship with other anger measures, anxiety/depression, and aggression were examined. NAS-PI was found to have high reliability, concurrent validity, and discriminant validity, and its scores discriminated the samples. High scores in the offender group demonstrated the feasibility of obtaining self-report assessments of anger with this population. Retrospective and prospective validity of the NAS were tested with the forensic patient sample regarding physically aggressive behavior in hospital. Regression analyses showed that higher scores on NAS increase the risk of having acted aggressively in the past and of acting aggressively in the future. © The Author(s) 2015.

Fingolimod hydrochloride for the treatment of relapsing remitting multiple sclerosis.

PubMed

Thomas, Katja; Proschmann, Undine; Ziemssen, Tjalf

2017-10-01

Fingolimod was the first oral and the first in class disease modifying treatment in multiple sclerosis that acts as sphingosine-1-phospathe receptor agonist. Since approval in 2010 there is a growing experience with fingolimod use in clinical practice, but also next-generation sphingosin-1-receptor agonists in ongoing clinical trials. Growing evidence demonstrates additional effects beyond impact on lymphocyte circulation, highlighting further promising targets in multiple sclerosis therapy. Areas covered: Here we present a systematic review using PubMed database searching and expert opinion on fingolimod use in clinical practice. Long-term data of initial clinical trials and post-marketing evaluations including long-term efficacy, safety, tolerability and management especially within growing disease modifying treatment options and pre-treatment constellation in multiple sclerosis patients are critically discussed. Furthermore novel findings in mechanism of actions and prospective on additional use in progressive forms in multiple sclerosis are presented. Expert opinion: There is an extensive long-term experience on fingolimod use in clinical practice demonstrating the favorable benefit-risk of this drug. Using a defined risk management approach experienced MS clinicians should apply fingolimod after critical choice of patients and review of clinical aspects. Further studies are essential to discuss additional benefit in progressive forms in multiple sclerosis.

Using the Karolinska Sleep Questionnaire to identify obstructive sleep apnea syndrome in a sleep clinic population.

PubMed

Westerlund, Anna; Brandt, Lena; Harlid, Richard; Åkerstedt, Torbjörn; Lagerros, Ylva Trolle

2014-10-01

In Scandinavia, portable monitoring has virtually replaced standard polysomnography for diagnosis of obstructive sleep apnea syndrome (OSAS). Because waiting times for specialized OSAS care remain long, an accurate screening tool to exclude low-risk patients from diagnostic testing would be valuable. To examine the diagnostic accuracy of the Karolinska Sleep Questionnaire (KSQ) for OSAS. Consecutive patients, 30–66 years old, attending a large sleep clinic in Sweden for OSAS evaluation completed the KSQ and underwent in-home portable monitoring and medical history evaluation. OSAS was defined as apnea-hypopnea index ≥5 with symptoms of disease. We calculated sensitivity and specificity of apnea/snoring and sleepiness indices of the KSQ. Retrospectively, we combined six KSQ items (snoring, breathing cessations, disturbed sleep, etc.) and four clinical variables (age, sex, body mass index, smoking status) predictive of OSAS into a new instrument, which we also evaluated. Instrument score ranged between 0 and 21; a higher score indicated more severe symptoms. Of 103 patients, 62 were diagnosed with OSAS. Sensitivity and specificity of the indices were 0.56 and 0.68 (apnea/snoring), and 0.37 and 0.71 (sleepiness). The new instrument performed optimally at a score of 9. Sensitivity was 0.76 (95% confidence interval 0.63–0.86) and specificity 0.88 (0.74–0.96). Between 19.4% and 50.5% of patients were unaware of having apnea/snoring symptoms. Diagnostic accuracy of the apnea/snoring and sleepiness indices for OSAS was poor but could be improved by combining clinical and KSQ items. The usefulness of the apnea/snoring index and the combined instrument was questionable because of extensive symptom unawareness.

Best practices recommendations for chiropractic care for infants, children, and adolescents: results of a consensus process.

PubMed

Hawk, Cheryl; Schneider, Michael; Ferrance, Randy J; Hewitt, Elise; Van Loon, Meghan; Tanis, Lora

2009-10-01

There has been much discussion about the role of chiropractic care in the evaluation, management, and treatment of pediatric patients. To date, no specific guidelines have been adopted that address this issue from an evidence based perspective. Previous systematic reviews of the chiropractic literature concluded that there is not yet a substantial body of high quality evidence from which to develop standard clinical guidelines. The purpose of this project was to develop recommendations on "best practices" related primarily to the evaluation and spinal manipulation aspects of pediatric chiropractic care; nonmanipulative therapies were not addressed in detail. Based on both clinical experience and the results of an extensive literature search, a set of seed documents was compiled to inform development of the seed statements. These were circulated electronically to the Delphi panel until consensus was reached, which was considered to be present when there was agreement by at least 80% of the panelists. A multidisciplinary panel of 37 was made up primarily of doctors of chiropractic with a mean of 18 years in practice, many with post-graduate training in pediatrics. The panel represented 5 countries and 17 states; there were members of the American Chiropractic Association, the International Chiropractors Association, and the International Chiropractic Pediatric Association. The panel reached a minimum of 80% consensus on the 51 seed statements after 4 rounds. A broad-based panel of experienced chiropractors was able to reach a high level (80%) of consensus regarding specific aspects of the chiropractic approach to clinical evaluation, management, and manual treatment for pediatric patients, based on both scientific evidence and clinical experience.

Biosimilars in rheumatology: A review of the evidence and their place in the treatment algorithm

PubMed Central

Skapenko, Alla

2017-01-01

Abstract Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations. Guidelines on the treatment of rheumatic diseases have acknowledged that biosimilars and biologic DMARDs (bDMARDs) are interchangeable in clinical practice, except when patients experience lack of efficacy or tolerability with the reference agent. Given that cost is a barrier to effective bDMARD use, the introduction of less costly biosimilars is likely to widen access and dissipate treatment inequalities. Physicians faced with prescribing decisions should be reassured by the robust and exhaustive process that is involved in assuring comparability of biosimilars with their reference agents. De novo usage of a biosimilar and switching to a biosimilar following lack of efficacy or tolerability with a different reference biologic agent are likely to be strategies most easily adopted, although switching during successful treatment should also be considered given the potential cost implications. The introduction of biosimilar bDMARDs has the potential to improve patient access to effective biologic therapy, to better accommodate restraints within healthcare budgets and to improve overall patient outcomes. PMID:28903543

Immunotoxins Constructed with Ribosome-Inactivating Proteins and their Enhancers: A Lethal Cocktail with Tumor Specific Efficacy

PubMed Central

Gilabert-Oriol, Roger; Weng, Alexander; von Mallinckrodt, Benedicta; Melzig, Matthias F; Fuchs, Hendrik; Thakur, Mayank

2014-01-01

The term ribosome-inactivating protein (RIP) is used to denominate proteins mostly of plant origin, which have N-glycosidase enzymatic activity leading to a complete destruction of the ribosomal function. The discovery of the RIPs was almost a century ago, but their usage has seen transition only in the last four decades. With the advent of antibody therapy, the RIPs have been a subject of extensive research especially in targeted tumor therapies, which is the primary focus of this review. In the present work we enumerate 250 RIPs, which have been identified so far. An attempt has been made to identify all the RIPs that have been used for the construction of immunotoxins, which are conjugates or fusion proteins of an antibody or ligand with a toxin. The data from 1960 onwards is reviewed in this paper and an extensive list of more than 450 immunotoxins is reported. The clinical reach of tumor-targeted toxins has been identified and detailed in the work as well. While there is a lot of potential that RIPs embrace for targeted tumor therapies, the success in preclinical and clinical evaluations has been limited mainly because of their inability to escape the endo/lysosomal degradation. Various strategies that can increase the efficacy and lower the required dose for targeted toxins have been compiled in this article. It is plausible that with the advancements in platform technologies or improved endosomal escape the usage of tumor targeted RIPs would see the daylight of clinical success. PMID:25341935

Fabricating specialised orthopaedic implants using additive manufacturing

NASA Astrophysics Data System (ADS)

Unwin, Paul

2014-03-01

It has been hypothesised that AM is ideal for patient specific orthopaedic implants such as those used in bone cancer treatment, that can rapidly build structures such as lattices for bone and tissues to in-grow, that would be impossible using current conventional subtractive manufacturing techniques. The aim of this study was to describe the adoption of AM (direct metal laser sintering and electron beam melting) into the design manufacturing and post-manufacturing processes and the early clinical use. Prior to the clinical use of AM implants, extensive metallurgical and mechanical testing of both laser and electron beam fabrications were undertaken. Concurrently, post-manufacturing processes evaluated included hipping, cleaning and coating treatments. The first clinical application of a titanium alloy mega-implant was undertaken in November 2010. A 3D model of the pelvic wing implant was designed from CT scans. Novel key features included extensive lattice structures at the bone interfaces and integral flanges to fix the implant to the bone. The pelvic device was implanted with the aid of navigation and to date the patient remains active. A further 18 patient specific mega-implants have now been implanted. The early use of this advanced manufacturing route for patient specific implants has been very encouraging enabling the engineer to produce more advanced and anatomical conforming implants. However, there are a new set of design, manufacturing and regulatory challenges that require addressing to permit this technique to be used more widely. This technology is changing the design and manufacturing paradigm for the fabrication of specialised orthopaedic implants.

Clinicopathologic characteristics associated with long-term survival in advanced epithelial ovarian cancer: an NRG Oncology/Gynecologic Oncology Group ancillary data study.

PubMed

Hamilton, C A; Miller, A; Casablanca, Y; Horowitz, N S; Rungruang, B; Krivak, T C; Richard, S D; Rodriguez, N; Birrer, M J; Backes, F J; Geller, M A; Quinn, M; Goodheart, M J; Mutch, D G; Kavanagh, J J; Maxwell, G L; Bookman, M A

2018-02-01

To identify clinicopathologic factors associated with 10-year overall survival in epithelial ovarian cancer (EOC) and primary peritoneal cancer (PPC), and to develop a predictive model identifying long-term survivors. Demographic, surgical, and clinicopathologic data were abstracted from GOG 182 records. The association between clinical variables and long-term survival (LTS) (>10years) was assessed using multivariable regression analysis. Bootstrap methods were used to develop predictive models from known prognostic clinical factors and predictive accuracy was quantified using optimism-adjusted area under the receiver operating characteristic curve (AUC). The analysis dataset included 3010 evaluable patients, of whom 195 survived greater than ten years. These patients were more likely to have better performance status, endometrioid histology, stage III (rather than stage IV) disease, absence of ascites, less extensive preoperative disease distribution, microscopic disease residual following cyoreduction (R0), and decreased complexity of surgery (p<0.01). Multivariable regression analysis revealed that lower CA-125 levels, absence of ascites, stage, and R0 were significant independent predictors of LTS. A predictive model created using these variables had an AUC=0.729, which outperformed any of the individual predictors. The absence of ascites, a low CA-125, stage, and R0 at the time of cytoreduction are factors associated with LTS when controlling for other confounders. An extensively annotated clinicopathologic prediction model for LTS fell short of clinical utility suggesting that prognostic molecular profiles are needed to better predict which patients are likely to be long-term survivors. Published by Elsevier Inc.

Clinicopathologic characteristics associated with long-term survival in advanced epithelial ovarian cancer: an NRG Oncology/Gynecologic Oncology Group ancillary data study

PubMed Central

Hamilton, C. A.; Miller, A.; Casablanca, Y.; Horowitz, N. S.; Rungruang, B.; Krivak, T. C.; Richard, S. D.; Rodriguez, N.; Birrer, M.J.; Backes, F.J.; Geller, M.A.; Quinn, M.; Goodheart, M.J.; Mutch, D.G.; Kavanagh, J.J.; Maxwell, G. L.; Bookman, M. A.

2018-01-01

Objective To identify clinicopathologic factors associated with 10-year overall survival in epithelial ovarian cancer (EOC) and primary peritoneal cancer (PPC), and to develop a predictive model identifying long-term survivors. Methods Demographic, surgical, and clinicopathologic data were abstracted from GOG 182 records. The association between clinical variables and long-term survival (LTS) (>10 years) was assessed using multivariable regression analysis. Bootstrap methods were used to develop predictive models from known prognostic clinical factors and predictive accuracy was quantified using optimism-adjusted area under the receiver operating characteristic curve (AUC). Results The analysis dataset included 3,010 evaluable patients, of whom 195 survived greater than ten years. These patients were more likely to have better performance status, endometrioid histology, stage III (rather than stage IV) disease, absence of ascites, less extensive preoperative disease distribution, microscopic disease residual following cyoreduction (R0), and decreased complexity of surgery (p<0.01). Multivariable regression analysis revealed that lower CA-125 levels, absence of ascites, stage, and R0 were significant independent predictors of LTS. A predictive model created using these variables had an AUC=0.729, which outperformed any of the individual predictors. Conclusions The absence of ascites, a low CA-125, stage, and R0 at the time of cytoreduction are factors associated with LTS when controlling for other confounders. An extensively annotated clinicopathologic prediction model for LTS fell short of clinical utility suggesting that prognostic molecular profiles are needed to better predict which patients are likely to be long-term survivors. PMID:29195926

Feline restrictive orbital myofibroblastic sarcoma in a cat – Cross sectional imaging (MRI & CT) appearance, treatment and outcome

PubMed Central

Thomasy, Sara M.; Cissell, Derek D.; Arzi, Boaz; Vilches-Moure, Jose G.; Lo, Winnie Y.; Wisner, Erik R.; Dubielzig, Richard R.; Maggs, David J.

2012-01-01

Case Description A 16-year-old spayed female cat evaluated for lagophthalmos and chronic exposure keratitis in both eyes. Clinical Findings Ophthalmic examination revealed upper and lower eyelid entropion of the left eye (OS) and markedly decreased retropulsion, restricted eye movement, marked episcleral congestion, and severe keratitis of both eyes (OU). Magnetic resonance imaging of both orbits revealed extensive, irregular, contrast-enhancing tissue without evidence of osteolysis considered compatible with diffuse inflammatory tissue. Feline herpesvirus DNA was not detected in conjunctival samples. Treatment and Outcome Partial temporary tarsorrhaphies were placed OU and the cat was treated with topically administered erythromycin ointment OU, orally administered famciclovir and prednisolone, and sublingually administered buprenorphine. Little improvement was noted after 2 weeks. Six weeks after presentation, a left exenteration was performed and histopathology was consistent with idiopathic sclerosing orbital pseudotumor (ISOP). Ten weeks after presentation, the patient presented for weight loss and jaw pain. Computed tomography demonstrated disease progression in the right orbit and the patient was euthanized. Histopathology of the decalcified skull revealed an aggressive and highly infiltrative mass involving the right orbit with extension to the maxilla, hard palate, nasal cavity and gingiva most consistent with feline restrictive orbital myofibroblastic sarcoma (FROMS). Clinical Relevance Clinical data from this patient support the reclassification of ISOP as FROMS. MRI and CT may provide supportive evidence for FROMS but histopathology is necessary for definitive diagnosis. Aggressive and early surgical treatment, including bilateral exenteration, with adjunctive radiotherapy and/or chemotherapy should be considered for patients with FROMS. PMID:23281709

Extensive clinical experience: relative prevalence of different androgen excess disorders in 950 women referred because of clinical hyperandrogenism.

PubMed

Carmina, E; Rosato, F; Jannì, A; Rizzo, M; Longo, R A

2006-01-01

We undertook this study to estimate the prevalence of the various androgen excess disorders using the new criteria suggested for the diagnosis of polycystic ovary syndrome (PCOS). The study was performed at two endocrine departments at the University of Palermo (Palermo, Italy). The records of all patients referred between 1980 and 2004 for evaluation of clinical hyperandrogenism were reevaluated. All past diagnoses were reviewed using the actual diagnostic criteria. To be included in this study, the records of the patients had to present the following available data: clinical evaluation of hyperandrogenism, body weight and height, testosterone (T), free T, dehydroepiandrosterone sulfate, 17-hydroxyprogesterone, progesterone, and pelvic sonography. A total of 1226 consecutive patients were seen during the study period, but only the scores of 950 patients satisfied all criteria and were reassessed for the diagnosis. The prevalence of androgen excess disorders was: PCOS, 72.1% (classic anovulatory patients, 56.6%; mild ovulatory patients, 15.5%), idiopathic hyperandrogenism, 15.8%; idiopathic hirsutism, 7.6%; 21-hydroxylase-deficient nonclassic adrenal hyperplasia, 4.3%; and androgen-secreting tumors, 0.2%. Compared with other androgen excess disorders, patients with PCOS had increased body weight whereas nonclassic adrenal hyperplasia patients were younger and more hirsute and had higher serum levels of T, free T, and 17-hydroxyprogesterone. Classic PCOS is the most common androgen excess disorder. However, mild androgen excess disorders (ovulatory PCOS and idiopathic hyperandrogenism) are also common and, in an endocrine setting, include about 30% of patients with clinical hyperandrogenism.

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

PubMed

Ward, Amanda M

2016-11-01

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

A retrospective review of general surgery training outcomes at the University of Toronto

PubMed Central

Compeau, Christopher; Tyrwhitt, Jessica; Shargall, Yaron; Rotstein, Lorne

2009-01-01

Background Surgical educators have struggled with achieving an optimal balance between the service workload and education of surgical residents. In Ontario, a variety of factors during the past 12 years have had the net impact of reducing the clinical training experience of general surgery residents. We questioned what impact the reductions in trainee workload have had on general surgery graduates at the University of Toronto. Methods We evaluated graduates from the University of Toronto general surgery training program from 1995 to 2006. We compared final-year In-Training Evaluation Reports (ITERs) of trainees during this interval. For purposes of comparison, we subdivided residents into 4 groups according to year of graduation (1995–1997, 1998–2000, 2001–2003 and 2004–2006). We evaluated postgraduate “performance” by categorizing residents into 1 of 4 groups: first, residents who entered directly into general surgery practice after graduation; second, residents who entered into a certification subspecialty program of the Royal College of Physicians and Surgeons of Canada (RCPSC); third, residents who entered into a noncertification program of the RCPSC; and fourth, residents who entered into a variety of nonregulated “clinical fellowships.” Results We assessed and evaluated 118 of 134 surgical trainees (88%) in this study. We included in the study graduates for whom completed ITER records were available and postgraduate training records were known and validated. The mean scores for each of the 5 evaluated residency training parameters included in the ITER (technical skills, professional attitudes, application of knowledge, teaching performance and overall performance) were not statistically different for each of the 4 graduating groups from 1995 to 2006. However, we determined that there were statistically fewer general surgery graduates (p < 0.05) who entered directly into general surgery practice in the 2004–2006 group compared with the 1998–2000 and 2001–2003 groups. The graduates from 2004 to 2006 who did not enter into general surgery practice appeared to choose a clinical fellowship. Conclusion These observations may indicate that recent surgical graduates possess an acceptable skill set but may lack the clinical confidence and experience to enter directly into general surgery practice. Evidence seems to indicate that the clinical fellowship has become an unregulated surrogate extension of the training program whereby surgeons can gain additional clinical experience and surgical expertise. PMID:19865542

Hip abductor, trunk extensor and ankle plantar flexor endurance in females with and without patellofemoral pain.

PubMed

Van Cant, Joachim; Pitance, Laurent; Feipel, Véronique

2017-01-01

Previous studies have reported strength deficit in hip abduction, extension and external rotation in females with patellofemoral pain (PFP) when compared with healthy control; however, there is conflicting evidence for a decrease in hip muscle endurance. Therefore, it seems important to evaluate hip muscle endurance in females with PFP. Moreover, trunk extensor and ankle plantar flexor endurance have not yet been evaluate in females with PFP. To compare hip abductor, trunk extensor and ankle plantar flexor endurance between females with and without PFP. Twenty females with PFP (mean age, 21.1 years) and 76 healthy females (mean age, 20.5 years) were recruited. Subject performed three endurance clinical tests: (1) The hip abductor isometric endurance test, (2) The Sorensen test and (3) The heel rise test. Group differences were assessed using an independent t tests, or Mann-Whitney U tests for non-normally distributed data. Subjects with PFP exhibited significantly lower hip abductor, trunk extensor and ankle plantar flexor endurance than healthy controls. On average, subjects with PFP had deficits of 16% in hip abduction, 14% in trunk extension and 26% in ankle plantar flexion. Females with PFP exhibited diminished hip abductor, trunk extensor and ankle plantar flexor endurance compared to healthy controls.

The effect of toe marker placement error on joint kinematics and muscle forces using OpenSim gait simulation.

PubMed

Xu, Hang; Merryweather, Andrew; Bloswick, Donald; Mao, Qi; Wang, Tong

2015-01-01

Marker placement can be a significant source of error in biomechanical studies of human movement. The toe marker placement error is amplified by footwear since the toe marker placement on the shoe only relies on an approximation of underlying anatomical landmarks. Three total knee replacement subjects were recruited and three self-speed gait trials per subject were collected. The height variation between toe and heel markers of four types of footwear was evaluated from the results of joint kinematics and muscle forces using OpenSim. The reference condition was considered as the same vertical height of toe and heel markers. The results showed that the residual variances for joint kinematics had an approximately linear relationship with toe marker placement error for lower limb joints. Ankle dorsiflexion/plantarflexion is most sensitive to toe marker placement error. The influence of toe marker placement error is generally larger for hip flexion/extension and rotation than hip abduction/adduction and knee flexion/extension. The muscle forces responded to the residual variance of joint kinematics to various degrees based on the muscle function for specific joint kinematics. This study demonstrates the importance of evaluating marker error for joint kinematics and muscle forces when explaining relative clinical gait analysis and treatment intervention.

Clinical evaluation of final impressions from three-dimensional printed custom trays.

PubMed

Sun, Yuchun; Chen, Hu; Li, Hong; Deng, Kehui; Zhao, Tian; Wang, Yong; Zhou, Yongsheng

2017-11-02

This study aimed to evaluate the quality of the final impressions taken by three-dimensional printed custom trays for edentulous patients. Custom trays were designed with or without saddle-shaped tissue stops and fabricated by three-dimensional printing techniques. Manually made trays with photocurable materials were produced as controls. Both 3D printed custom trays and manually made ones were used to take impressions from edentulous patients. After 3D scanning of the final impression, the impression materials were removed, thus the underneath tray surfaces were able to be scanned, allowing the thickness of the impression materials to be measured. Final impressions obtained by pre-border-molded 3D printed trays were scanned as references, to which the flange extension deviations and morphology deviations of the impressions taken by both 3D printed trays and manually made ones were calculated. The results showed that (1) impressions from 3D printed custom trays had better thickness distribution than that of manually made ones; (2) impression morphology deviations in non-marginal area were neither statistic different between 3D printed trays and manually made trays, nor between trays with and without tissue stops; and (3) final impressions taken by custom trays without pre-border-molding were tended to have insufficient flange extensions.

Extreme Right Axis Deviation in Acute Myocardial Infarction: A Hazardous Signal of Poor Prognosis.

PubMed

Wang, Qingyu; Pan, Shuo; Liu, Fuqiang; Yang, Dan; Wang, Jun-Kui

2018-05-11

BACKGROUND New-onset extreme right axis deviation and right bundle branch block (RBBB) are rare during acute myocardial infarction (AMI), and has only been reported in several cases reflecting the severity of AMI. It could predict severe clinical complications and higher risks in coronary artery disease. Although there is little electrophysiological explanation, the complications are severe. They should be emphasized in newly diagnosed extreme right axis deviation and RBBB in AMI. CASE REPORT A 72-year-old male was admitted to our department with a chief complaint of intermittent retrosternal chest pain and was diagnosed with extensive anterior myocardial infarction with RBBB, by elevated myocardial enzymes and ECG. The main wave direction of QRS in lead aVR was positive and showed an extreme right axis deviation. After a month, the patient's chest distress and the RBBB vanished, but a right axis deviation still existed. The echocardiogram showed prior extensive anterior myocardial infarction (including apex myocardia) and lower LVEF. CONCLUSIONS New diagnosed RBBB and right axis deviation is uncommon and could be a useful clue to evaluate myocardial ischemia in AMI cases. This electrocardiographic marker can identify coronary artery occlusion where ST-segments are hard to evaluate, and hence, patients may benefit most from early and complete revascularization strategies such as primary angioplasty.

A novel closed reduction with extension block and flexion block using Kirschner wires and microscrew fixation for mallet fractures.

PubMed

Shimura, Haruhiko; Wakabayashi, Yoshiaki; Nimura, Akimoto

2014-03-01

Some patients with mallet fractures who undergo extension block pinning complain of exposed wires, which delay their return to sports and causes inconvenience while performing tasks that require the use of hands during the early postoperative period. The purpose of this retrospective study was to present and evaluate a novel surgical procedure for mallet fractures. We treated 20 patients (14 males and six females; mean age, 38.4 years; range 17-68 years) with displaced mallet fractures involving >30 % of the articular surface using the closed reduction and microscrew fixation between January 2009 and January 2012. The distal interphalangeal joint (DIP) joint was immobilized with a splint for 1-3 weeks on an individual case basis. According to Wehbe and Schneider's classification, there were 12 type IB, six type IIB, and two type IA fractures. The mean follow-up duration was 12.6 months (range 6-31 months). Bone union was achieved in all patients within a mean period of 6.8 weeks, with no incidence of infection, skin necrosis, permanent nail deformity, or secondary osteoarthritis. Only two complications-temporary nail ridging in one patient and a dorsal bump caused by the screw in one patient-were observed. Minimum postoperative displacement was observed in one patient, for whom immobilization with a splint was continued for 4 weeks. Articular incongruity was <1.0 mm in four patients and 1.0-2.0 mm in two patients. Mean DIP joint extension loss was 6.5° and mean flexion was 67.8°. The surgical outcomes were excellent in seven patients, good in nine, and fair in four according to Crawford's evaluation criteria. Our novel surgical procedure combining closed reduction with extension block and flexion block using Kirschner wires and microscrew fixation produces good clinical results with relatively few complications.

Sup wit Eval Ext?

ERIC Educational Resources Information Center

Patton, Michael Quinn

2008-01-01

Extension and evaluation share some similar challenges, including working with diverse stakeholders, parallel processes for focusing priorities, meeting common standards of excellence, and adapting to globalization, new technologies, and changing times. Evaluations of extension programs have helped clarify how change occurs, especially the…

77 FR 46750 - Agency Information Collection Extension

Federal Register 2010, 2011, 2012, 2013, 2014

2012-08-06

... Questionnaire Testing, Evaluation, and Research.'' The proposed collection will utilize qualitative and quantitative methodologies to pretest questionnaires and validate EIA survey forms data quality, including..., Evaluation, and Research; (3) Type of Request: Extension, Without Change, of a Previously Approved Collection...

Comprehensive obesity evaluation and treatment of three adolescents: a case series.

PubMed

Taylor, Sharonda J Alston; Peterson, Mitchell A; Garland, Beth H; Hastings, Elisabeth S

2016-02-01

Adolescent obesity is a chronic disease that is impacted from each patient's biopsychosocial milieu. Successfully treating pediatric obesity requires long-term, innovative, systematic involvement to facilitate patient and family engagement and change. Extensive chart review was done for three obese adolescents who underwent comprehensive weight management in an adolescent clinic seen within the past 5 years. The charts were reviewed starting from the time of initial contact through the last visit in the clinic. The patients are no longer receiving care within the clinic. The patients presented with BMI>99th percentile, family history of obesity, severe psychosocial stressors, and multiple obesity-related comorbidities. Their treatment involved comprehensive multidisciplinary intervention in an adolescent weight management clinic within a tertiary care center. In addition to rigorous support through frequent office visits, these patients all eventually required temporary, alternative living arrangements to successfully implement recommendations. One patient resided with another family member; two went to inpatient weight management program care for 2-3 months. All subjects successfully lost weight when away from their primary residence, and they demonstrated improvement or resolution of comorbidities. This case series of three adolescents who underwent comprehensive obesity evaluation and treatment demonstrates multidisciplinary care across interconnected treatment programs and active engagement of family. Those who maintained successful weight loss reduced sedentary time, demonstrated family support (e.g., key members attending follow-up visits), and altered their living environment and were committed to their own health goals.

Outcome measures in European patients with haemophilia: Survey of implementation in routine clinical practice, perception of relevance and recommendations by European treaters in the EHTSB.

PubMed

Hermans, C; Klamroth, R; Richards, M; de Moerloose, P; Garrido, R P

2017-03-01

This study was conducted to evaluate the current implementation of outcome measures in routine clinical haemophilia practice and to explore and appreciate the perception of the relevance of such measures by treaters. A survey was completed by 19 of the 26 physicians involved in the European Haemophilia Therapy Strategy Board (EHTSB). Employing an extensive inventory of outcome measures used in patients with haemophilia, information was collected about the frequency of data collection and the subjective appreciation of their importance during clinic review. The survey revealed that most treaters currently collect data that are mainly related to the haemostatic treatment (consumption of concentrates) and the bleeding symptoms (number and location of bleeds) in a non-uniform and non-standardized way. By contrast, functional, physical and quality of life scorings are rarely used and show considerable heterogeneity between treaters. Also, many disparities emerged between practice and perception, in particular quality of life data that are perceived as being important but for most of the time are not collected. This survey represents, in our view, the first attempt to evaluate the actual utilization of outcome measures in haemophilia care. While the value of outcome measures is appreciated, they are not assessed regularly. Therefore, there is a need to include appropriate performance indicators (outcome measures) of haemophilia care in routine clinical practice. Consensus recommendations to provide a framework for achieving this aim are provided. © 2016 John Wiley & Sons Ltd.

Antibiotics for human toxoplasmosis: a systematic review of randomized trials

PubMed Central

Rajapakse, Senaka; Chrishan Shivanthan, Mitrakrishnan; Samaranayake, Nilakshi; Rodrigo, Chaturaka; Deepika Fernando, Sumadhya

2013-01-01

The efficacy of different treatment regimens in clinical syndromes of toxoplasmosis were assessed by conducting a systematic review of published randomized clinical trials through extensive searches in MEDLINE, EMBASE, and SCOPUS with no date limits, as well as manual review of journals. Outcome measures varied depending on the clinical entity of toxoplasmosis. Risk of bias was evaluated and quality of evidence was graded. Fourteen randomized trials were included of which one was a non-comparative study. One well-designed trial showed that trimethoprim-sulphamethoxazole was more effective than placebo for clinical recovery of toxoplasmic lymphadenopathy in immunocompetent hosts. For toxoplasmic encephalopathy, efficacy of pyrimethamine+sulphadiazine and trimethoprim+sulphamethoxazole were similar, whereas pyrimethamine+sulphadiazine versus pyrimathamine+clindamycin showed no difference, irrespective of the outcome. Intravitreal clindamycin+dexamethasone and conventional treatment with oral pyrimethamine+sulphadiazine had similar efficacy with regard to all outcome measures in ocular toxoplasmosis, and intravitreal therapy was found to be safe. Adverse effects seemed more common with pyrimethamine+sulphadiazine. Most trials for encephalitis and ocular manifestations had a high risk of bias and were of poor methodological quality. There were no trials evaluating drugs for toxoplasmosis in pregnancy, or for congenital toxoplasmosis. Pyrimethamine+sulphadiazine is an effective therapy for treatment of toxoplasmic encephalitis; trimethoprim+sulphamethoxazole and pyrimethamine+clindamycin are possible alternatives. Treatment with either oral or intravitreal antibiotics seems reasonable for ocular toxoplasmosis. Overall, trial evidence for the efficacy of these drugs for toxoplasmosis is poor, and further well-designed trials are needed. PMID:23816507

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/

Transconjuctival Incision with Lateral Paracanthal Extension for Corrective Osteotomy of Malunioned Zygoma

PubMed Central

Chung, Jae-Ho; You, Hi-Jin; Hwang, Na-Hyun; Yoon, Eul-Sik

2016-01-01

Background Conventional correction of malunioned zygoma requires complete regional exposure through a bicoronal flap combined with a lower eyelid incision and an upper buccal sulcus incision. However, there are many potential complications following bicoronal incisions, such as infection, hematoma, alopecia, scarring and nerve injury. We have adopted a zygomaticofrontal suture osteotomy technique using transconjunctival incision with lateral paracanthal extension. We performed a retrospective review of clinical cases underwent correction of malunioned zygoma with the approach to evaluate outcomes following this method. Methods Between June 2009 and September 2015, corrective osteotomies were performed in 14 patients with malunioned zygoma by a single surgeon. All 14 patients received both upper gingivobuccal and transconjunctival incisions with lateral paracanthal extension. The mean interval from injury to operation was 16 months (range, 12 months to 4 years), and the mean follow-up was 1 year (range, 4 months to 3 years). Results Our surgical approach technique allowed excellent access to the infraorbital rim, orbital floor, zygomaticofrontal suture and anterior surface of the maxilla. Of the 14 patients, only 1 patient suffered a complication—oral wound dehiscence. Among the 6 patients who received infraorbital nerve decompression, numbness was gradually relieved in 4 patients. Two patients continued to experience persistent numbness. Conclusion Transconjunctival incision with lateral paracanthal extension combined with upper gingivobuccal sulcus incision offers excellent exposure of the zygoma-orbit complex, and could be a valid alternative to the bicoronal approach for osteotomy of malunioned zygoma. PMID:28913268

Decreased neck muscle strength in patients with the loss of cervical lordosis.

PubMed

Alpayci, Mahmut; Şenköy, Emre; Delen, Veysel; Şah, Volkan; Yazmalar, Levent; Erden, Metin; Toprak, Murat; Kaplan, Şeyhmus

2016-03-01

The loss of cervical lordosis is associated with some negative clinical outcomes. No previous study has examined cervical muscle strength, specifically in patients with the loss of cervical lordosis. This study aims to investigate whether there is weakness of the cervical muscles or an imbalance between cervical flexor and extensor muscle strength in patients with the loss of cervical lordosis compared with healthy controls matched by age, gender, body mass index (BMI), and employment status. Thirty-two patients with the loss of cervical lordosis (23 F, 9 M) and 31 healthy volunteers (23 F, 8 M) were included in the study. Maximal isometric neck extension and flexion strength, and the strength ratio between extension and flexion were used as evaluation parameters. All measurements were conducted by a blinded assessor using a digital force gauge. The participants were positioned on a chair in a neutral cervical position and without the trunk inclined during measurements. Maximal isometric neck extension and flexion strength values were significantly lower in the patients versus healthy controls (P<0.001 and P=0.040, respectively). The mean (SD) values of the extension/flexion ratio were 1.21 (0.34) in the patients and 1.46 ± 0.33 in the controls (P=0.004). According to our results, patients with the loss of cervical lordosis have reduced neck muscle strength, especially in the extensors. These findings may be beneficial for optimizing cervical exercise prescriptions. Copyright © 2016 Elsevier Ltd. All rights reserved.

Functional optical coherence tomography: principles and progress

NASA Astrophysics Data System (ADS)

Kim, Jina; Brown, William; Maher, Jason R.; Levinson, Howard; Wax, Adam

2015-05-01

In the past decade, several functional extensions of optical coherence tomography (OCT) have emerged, and this review highlights key advances in instrumentation, theoretical analysis, signal processing and clinical application of these extensions. We review five principal extensions: Doppler OCT (DOCT), polarization-sensitive OCT (PS-OCT), optical coherence elastography (OCE), spectroscopic OCT (SOCT), and molecular imaging OCT. The former three have been further developed with studies in both ex vivo and in vivo human tissues. This review emphasizes the newer techniques of SOCT and molecular imaging OCT, which show excellent potential for clinical application but have yet to be well reviewed in the literature. SOCT elucidates tissue characteristics, such as oxygenation and carcinogenesis, by detecting wavelength-dependent absorption and scattering of light in tissues. While SOCT measures endogenous biochemical distributions, molecular imaging OCT detects exogenous molecular contrast agents. These newer advances in functional OCT broaden the potential clinical application of OCT by providing novel ways to understand tissue activity that cannot be accomplished by other current imaging methodologies.

Functional Optical Coherence Tomography: Principles and Progress

PubMed Central

Kim, Jina; Brown, William; Maher, Jason R.; Levinson, Howard; Wax, Adam

2015-01-01

In the past decade, several functional extensions of optical coherence tomography (OCT) have emerged, and this review highlights key advances in instrumentation, theoretical analysis, signal processing and clinical application of these extensions. We review five principal extensions: Doppler OCT (DOCT), polarization-sensitive OCT (PS-OCT), optical coherence elastography (OCE), spectroscopic OCT (SOCT), and molecular imaging OCT. The former three have been further developed with studies in both ex vivo and in vivo human tissues. This review emphasizes the newer techniques of SOCT and molecular imaging OCT, which show excellent potential for clinical application but have yet to be well reviewed in the literature. SOCT elucidates tissue characteristics, such as oxygenation and carcinogenesis, by detecting wavelength-dependent absorption and scattering of light in tissues. While SOCT measures endogenous biochemical distributions, molecular imaging OCT detects exogenous molecular contrast agents. These newer advances in functional OCT broaden the potential clinical application of OCT by providing novel ways to understand tissue activity that cannot be accomplished by other current imaging methodologies. PMID:25951836