Development of gastric dysplasia in pernicious anaemia: a clinical and endoscopic follow up study of 80 patients.

OpenAIRE

Armbrecht, U; Stockbrügger, R W; Rode, J; Menon, G G; Cotton, P B

1990-01-01

The development of gastric dysplasia and neoplasia in patients with pernicious anaemia has been evaluated in a prospective clinical and endoscopic follow up study. After initial screening of 80 patients between 1978 and 1980, one patient underwent total gastrectomy for a gastric malignancy and 12 were kept under surveillance and underwent endoscopy at a mean interval of 14 months. In the remaining 67 patients further investigation was attempted six to seven years after the initial investigati...

N-of-1 trials in the clinical care of patients in developing countries: a systematic review.

Science.gov (United States)

Alemayehu, Chalachew; Nikles, Jane; Mitchell, Geoffrey

2018-04-23

N-of-1 trials have a potential role in promoting patient-centered medicine in developing countries. However, there is limited academic literature regarding the use of N-of-1 trials in the clinical care of patients in resource-poor settings. To assess the extent of use, purpose and treatment outcome of N-of-1 trials in developing countries. A systematic review of clinical N-of-1 trials was conducted between 1985 and September 2015 using PubMed, Embase, CINAHL, Web of Science and the Cochrane Central Register of Controlled Trials. Grey literature databases and clinical trial registers were also searched. This review included randomized, multi-cycle, crossover within individual patient trials involving drug intervention. Quality assessment and data extraction were conducted by two independent reviewers. Out of 131 N-of-1 trials identified, only 6 (4.5%) were conducted in developing countries. The major reason that N-of-1 trials were used was to provide evidence on feasibility, effectiveness and safety of therapies. A total of 72 participants were involved in these trials. Five of the studies were conducted in China and all evaluated Chinese traditional medicine. The remaining study was conducted in Brazil. The completion rate was 93%. More than half, 46 (69%) of subjects made medication changes consistent with trial results after trial completion. A number of threats to the validity of the included evidence limited the validity of the evidence. In particular, the estimated overall effect in four of the included studies could have been affected by the "carry over" of the previous treatment effect as no adequate pharmacokinetic evidence regarding traditional medicines was presented. The prevalence and scope of N-of-1 trials in developing countries is low. A coordinated effort among government, clinicians, researchers and sponsor organizations is needed to increase their uptake and quality in developing countries. PROSPERO CRD42015026841 .

Clinical review of 95 patients with 46,XX disorders of sex development based on the new Chicago classification.

Science.gov (United States)

Öcal, Gönül; Berberoğlu, Merih; Sıklar, Zeynep; Aycan, Zehra; Hacıhamdioglu, Bülent; Savas Erdeve, Şenay; Çamtosun, Emine; Kocaay, Pınar; Ruhi, Hatice I; Kılıç, Birim G; Tukun, Ajlan

2015-02-01

The aim of our study was to determine the etiologic distribution of 46,XX disorder of sexual development (DSD) according to the new DSD classification system and to evaluate the clinical features of this DSD subgroup in our patient cohort. The evaluation criteria and clinical findings of 95 46,XX patients were described by clinical presentation, gonadal morphology, genital anatomy, associated dysmorphic features, presence during prenatal period with/without postnatal virilization, hormonal characteristics, and presence or absence of steroidogenic defects among 319 patients with DSD. Types and ratios of each presentation of our 95 patients with 46,XX DSD were as follows: 82 had androgen excess (86.3%): (74 had classical congenital adrenal hyperplasia, 2 had CAH variant possibility of P450-oxidoreductase gene defect), 6 had disorders of ovarian development (6.3%): (1 patient had gonadal dysgenesis with virilization at birth with bilateral streak gonad, 4 patients had complete gonadal dysgenesis, and 1 patient had ovotesticular DSD) and 7 had other 46,XX DSD. Two sisters, who had 46,XX complete gonadal dysgenesis,were diagnosed with Perrault Syndrome with ovarian failure due to streak gonads and associated with sensorineural deafness. 46,XX DSD are usually derived from intrauterine virilization and CAH is the most common cause of 46,XX DSD due to fetal androgen exposure. Copyright © 2015 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.

Developing a stone database for clinical practice.

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Turney, Benjamin W; Noble, Jeremy G; Reynard, John M

2011-09-01

Our objective was to design an intranet-based database to streamline stone patient management and data collection. The system developers used a rapid development approach that removed the need for laborious and unnecessary documentation, instead focusing on producing a rapid prototype that could then be altered iteratively. By using open source development software and website best practice, the development cost was kept very low in comparison with traditional clinical applications. Information about each patient episode can be entered via a user-friendly interface. The bespoke electronic stone database removes the need for handwritten notes, dictation, and typing. From the database, files may be automatically generated for clinic letters, operation notes. and letters to family doctors. These may be printed or e-mailed from the database. Data may be easily exported for audits, coding, and research. Data collection remains central to medical practice, to improve patient safety, to analyze medical and surgical outcomes, and to evaluate emerging treatments. Establishing prospective data collection is crucial to this process. In the current era, we have the opportunity to embrace available technology to facilitate this process. The database template could be modified for use in other clinics. The database that we have designed helps to provide a modern and efficient clinical stone service.

Video-recorded simulated patient interactions: can they help develop clinical and communication skills in today's learning environment?

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Seif, Gretchen A; Brown, Debora

2013-01-01

It is difficult to provide real-world learning experiences for students to master clinical and communication skills. The purpose of this paper is to describe a novel instructional method using self- and peer-assessment, reflection, and technology to help students develop effective interpersonal and clinical skills. The teaching method is described by the constructivist learning theory and incorporates the use of educational technology. The learning activities were incorporated into the pre-clinical didactic curriculum. The students participated in two video-recording assignments and performed self-assessments on each and had a peer-assessment on the second video-recording. The learning activity was evaluated through the self- and peer-assessments and an instructor-designed survey. This evaluation identified several themes related to the assignment, student performance, clinical behaviors and establishing rapport. Overall the students perceived that the learning activities assisted in the development of clinical and communication skills prior to direct patient care. The use of video recordings of a simulated history and examination is a unique learning activity for preclinical PT students in the development of clinical and communication skills.

Predictors of clinical complications in patients with spinomedullary injury

Directory of Open Access Journals (Sweden)

Dionei Freitas De Morais

2014-01-01

Full Text Available Objective: To analyze individuals with spinal cord injury who developed secondary clinical complications, and the variables that can influence the prognosis. Methods: A prospective study of 321 patients with spinal cord injury. The variables were collected: age, sex, cause of the accident, anatomical distribution, neurological status, associated injuries, in-hospital complications, and mortality only in patients who developed complications. Results: A total of 72 patients were analyzed (85% male with a mean age of 44.72±19.19 years. The individuals with spinal cord injury who developed clinical complications were mostly male, over 50 years of age, and the main cause was accidental falls. These patients had longer hospitalization times and a higher risk of progressing to death. Pneumonia was the main clinical complication. With regard to the variables that can influence the prognosis of these patients, it was observed that spinal cord injury to the cervical segment with syndromic quadriplegia, and neurological status ASIA-A, have a higher risk of developing pneumonia, the most common complication, as well as increased mortality. Conclusion: Clinical complications secondary to spinal cord injury are influenced by demographic factors, as well as characteristics of the injury contributing to an increase in mortality.

Clinical and high-resolution computed tomographic findings in five patients with pulmonary tuberculosis who developed respiratory failure following chemotherapy

International Nuclear Information System (INIS)

Akira, Masanori; Sakatani, Mitsunori

2001-01-01

AIM: The purpose of this study was to describe the clinical and high-resolution computed tomographic (HRCT) findings in patients with pulmonary tuberculosis who developed respiratory failure after starting chemotherapy. MATERIALS AND METHODS: The clinical records, chest radiographs, and HRCT findings in five patients with non-miliary pulmonary tuberculosis who developed respiratory failure after starting chemotherapy were reviewed. RESULTS: Chest radiographs taken early in the course of acute respiratory failure showed progression of the original lesions with (n = 4) or without (n = 1) new areas of opacity away from the site of the original lesions. HRCT demonstrated widespread ground-glass attenuation with a reticular pattern as well as segmental or lobar consolidation with cavitation and nodules, consistent with active tuberculous foci in all five cases. Prominent interlobular septal thickening was seen in two cases. Four of the five patients had received corticosteroids. Of these five, two died and three recovered with continued corticosteroid therapy. Transbronchial biopsy in three cases showed evidence of acute alveolar damage. CONCLUSION: In selected patients with tuberculosis who develop respiratory failure following the initiation of antituberculous therapy, HRCT may be a helpful adjunct to clinical evaluation in differentiating hypersensitivity reactions (presumed to be due to the release of mycobacterial antigens) from other pulmonary complications. Akira, M. and Sakatani, M. (2001)

Patient representatives' views on patient information in clinical cancer trials.

Science.gov (United States)

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-02-01

Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I-III trials, randomized and non-randomized trials that evaluated chemotherapy/targeted therapy in the neoadjuvant, adjuvant and palliative settings. Data were collected through focus groups and were analysed using inductive content analysis. Two major themes emerged: emotional responses and cognitive responses. Subthemes related to the former included individual preferences and perceptions of effect, while subthemes related to the latter were comprehensibility and layout. Based on these observations the patient representatives provided suggestions for improvement, which largely included development of future simplified and more attractive informed consent forms. The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language, structured text and illustrations to improve the informed consent process and thereby patient enrolment into clinical trials.

Development of a computer-aided clinical patient education system to provide appropriate individual nursing care for psychiatric patients.

Science.gov (United States)

Tseng, Kuan-Jui; Liou, Tsan-Hon; Chiu, Hung-Wen

2012-06-01

A lot of researches have proven that health education can help patients to maintain and improve their health. And it also shortens the time staying in hospital to save medication resource. Because the patients are willing to get healthcare knowledge to enhance the ability of self-care, they pay more attention to the health education. In Taiwan, the clinical nurses play an important role in patient education, and the health education take most time in their daily work. Such work includes the collection, production and delivery of education materials. To generate the correct and customized health education material is the key of success of patient education. In this study, we established a computer-aided health education contents generating system for psychiatric patients by integrating the databases for disease, medicine and nursing knowledge to assist nurse generating the customized health education document suitable for different patients. This system was evaluated by clinical nurses in usability and feasibility. This system is helpful for nurse to carry out the clinical health education to patients and further to encourage patient to pay attention to self-health.

Microbial landscape features in patients with generalized periodontitis at pre-clinical and radiological stage of its development

Directory of Open Access Journals (Sweden)

Vatamanyuk N.V.

2014-11-01

Full Text Available The paper presents the results of a comparative study of microbial landscape features in patients with generalized periodontitis at pre-clinical and radiological stage of its development in 42 patients. The purpose of the study is a comparative study of the composition of microbiocenosis of periodontal tissues in patients with chronic catarrhal gingivitis (CCG and chronic generalized periodontitis (CGP at an early stage of development and development studies of microbiological criteria for early emergence of the destructive process in periodontal structures. We found that the microflora isolated from dento-gingival grooves is of importance in diagnostics to identify the etiology of chronic generalized catarrhal gingivitis (CGCG and chronic generalized periodontitis in the early stages of its development. It was established that the presence of two or more types of fixed parodonto-pathogenic microorganisms in microbial association increases the likelihood of inflammatory and destructive events in periodontal tissues in patients with GCCG and is one of the reasons of is becoming CGP.

Melanoma survivors at high risk of developing new primary disease: a qualitative examination of the factors that contribute to patient satisfaction with clinical care.

Science.gov (United States)

McLoone, J K; Watts, K J; Menzies, S W; Barlow-Stewart, K; Mann, G J; Kasparian, N A

2013-09-01

Providing ongoing clinical care that adequately addresses patients' medical, psychosocial and information needs is challenging, particularly for patient groups at increased risk of developing life-threatening disease such as malignant melanoma. This study examined a model of clinical care developed by the High Risk Clinic (HRC) of the Sydney Melanoma Diagnostic Centre in relation to patient satisfaction. Semi-structured telephone interviews were conducted and analyzed using the framework of Miles and Huberman, and themes were organized using the qualitative software package, QSR NVivo8. Twenty HRC patients participated in the study (nine men, 11 women; mean age 57.6 years, age range 34-74 years; response rate 91%). Satisfaction with clinical care at the HRC was high. Factors contributing to patient satisfaction included: rapid and regular access to physicians who were perceived by participants as experts, the development of confidence and trust in one's treating doctor, and a sense of being cared about and understood by one's healthcare team. Although one-third of the participants reported some inconveniences in attending the clinic, these were viewed as minor difficulties and not significant barriers to care. Formal psychological support was not sought or expected by participants, although many expressed long-standing melanoma-related fears and concerns. Accessible, expert medical attention, delivered in a patient-centered manner was integral to melanoma survivors' satisfaction with clinical management. Appropriate referrals to psychological support may further increase satisfaction with clinical care. Copyright © 2013 John Wiley & Sons, Ltd.

Development of a clinical prediction model to calculate patient life expectancy: the measure of actuarial life expectancy (MALE).

Science.gov (United States)

Clarke, M G; Kennedy, K P; MacDonagh, R P

2009-01-01

To develop a clinical prediction model enabling the calculation of an individual patient's life expectancy (LE) and survival probability based on age, sex, and comorbidity for use in the joint decision-making process regarding medical treatment. A computer software program was developed with a team of 3 clinicians, 2 professional actuaries, and 2 professional computer programmers. This incorporated statistical spreadsheet and database access design methods. Data sources included life insurance industry actuarial rating factor tables (public and private domain), Government Actuary Department UK life tables, professional actuarial sources, and evidence-based medical literature. The main outcome measures were numerical and graphical display of comorbidity-adjusted LE; 5-, 10-, and 15-year survival probability; in addition to generic UK population LE. Nineteen medical conditions, which impacted significantly on LE in actuarial terms and were commonly encountered in clinical practice, were incorporated in the final model. Numerical and graphical representations of statistical predictions of LE and survival probability were successfully generated for patients with either no comorbidity or a combination of the 19 medical conditions included. Validation and testing, including actuarial peer review, confirmed consistency with the data sources utilized. The evidence-based actuarial data utilized in this computer program design represent a valuable resource for use in the clinical decision-making process, where an accurate objective assessment of patient LE can so often make the difference between patients being offered or denied medical and surgical treatment. Ongoing development to incorporate additional comorbidities and enable Web-based access will enhance its use further.

Clinical protein science developments for patient monitoring in hospital central laboratories.

Science.gov (United States)

Malm, Johan; Marko-Varga, György

2016-12-01

Patient care relies heavily on standardized tests performed in hospital laboratories, typically including clinical chemistry, pathology and microbiology. With the introduction of personalized medicine tremendous efforts have been made to identify new biomarkers of disease with various omics technologies, often including mass spectrometry. In order to validate new biomarkers and perform clinical studies high quality biobank samples are of key importance. In this editorial different aspects of mass spectrometry in future personalized medicine are discussed.

STOPDVTs: Development and testing of a clinical assessment tool to guide nursing assessment of postoperative patients for Deep Vein Thrombosis.

Science.gov (United States)

O'Brien, Alanna; Redley, Bernice; Wood, Beverley; Botti, Mari; Hutchinson, Anastasia F

2018-03-01

To develop and test a clinical tool to guide nurses' assessment of postoperative patients for Deep Vein Thrombosis. Preventing venous thromboembolism in hospitalised patients is an international patient safety priority. Despite high-level evidence for optimal venous thromboembolism prophylaxis, implementation is inconsistent and the incidence of Deep Vein Thrombosis remains high. A two-stage sequential multi-method design was used. In stage 1, the STOPDVTs tool was developed using a review of the literature and focus groups with local clinical experts. Stage 2 involved pilot testing the tool with 38 surgical nurses who conducted repeated assessments on a prospective sample of 50 postoperative orthopaedic patients. Stage 1: The focus group members who were members of the nursing leadership team agreed on eight local and systemic signs and symptoms that should be included in a nursing patient assessment tool for early Deep Vein Thrombosis. Local symptoms were pain in the limbs, calf swelling and tightness, changes in the affected limb's skin temperature. Systemic signs included in the tool were as follows: increased shortness of breath, increased respiratory and heart rates, and decreased oxygen saturation. Stage 2: The STOPDVTs tool had acceptable face and content validity, the agreement between the expert nurse and surgical nurses on assessments of individual signs and symptoms varied between 44%-94%. Surgical nurses were less likely than the expert nurse to identify signs indicative of Deep Vein Thrombosis. Despite finding the STOPDVTs clinical assessment tool was a useful guide for nursing assessment, surgical nurses often underestimated the potential importance of clinical signs. The findings reveal a gap in nursing knowledge and skill in assessing for Deep Vein Thrombosis in postoperative orthopaedic patients. This study identified a possible risk to patient safety related to under-recognition of the signs and symptoms of possible Deep Vein Thrombosis (DVT) in

Patient Experiences with the Preoperative Assessment Clinic (PEPAC): validation of an instrument to measure patient experiences

NARCIS (Netherlands)

Edward, G. M.; Lemaire, L. C.; Preckel, B.; Oort, F. J.; Bucx, M. J. L.; Hollmann, M. W.; de Haes, J. C. J. M.

2007-01-01

Background. Presently, no comprehensive and validated questionnaire to measure patient experiences of the preoperative assessment clinic (PAC) is available. We developed and validated the Patient Experiences with the Preoperative Assessment Clinic (PEPAC) questionnaire, which can be used for

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

Energy Technology Data Exchange (ETDEWEB)

Vinogradskiy, Y; Waxweiler, T; Diot, Q; Kavanagh, B; Schubert, L; Miften, M [University of Colorado Denver, Aurora, CO (United States); Castillo, R [University of Texas Medical Branch of Galveston, Pearland, TX (United States); Guerrero, T; Castillo, E [Beaumont Health System, Royal Oak, MI (United States)

2015-06-15

Purpose: 4DCT-ventilation is an exciting new imaging modality that uses 4DCTs to calculate lung ventilation. Because 4DCTs are acquired as part of routine care, calculating 4DCT-ventilation allows for lung function evaluation without additional cost or inconvenience to the patient. Development of a clinical trial is underway at our institution to use 4DCT-ventilation for thoracic functional avoidance with the idea that preferential sparing of functional lung regions can decrease pulmonary toxicity. The purpose of our work was to develop the practical aspects of a 4DCT-ventilation functional avoidance clinical trial including: 1.assessing patient eligibility 2.developing trial inclusion criteria and 3.developing treatment planning and dose-function evaluation strategies. Methods: 96 stage III lung cancer patients from 2 institutions were retrospectively reviewed. 4DCT-ventilation maps were calculated using the patient’s 4DCTs, deformable image registrations, and a density-change-based algorithm. To assess patient eligibility and develop trial inclusion criteria we used an observer-based binary end point noting the presence or absence of a ventilation defect and developed an algorithm based on the percent ventilation in each lung third. Functional avoidance planning integrating 4DCT-ventilation was performed using rapid-arc and compared to the patient’s clinically used plan. Results: Investigator-determined clinical ventilation defects were present in 69% of patients. Our regional/lung-thirds ventilation algorithm identified that 59% of patients have lung functional profiles suitable for functional avoidance. Compared to the clinical plan, functional avoidance planning was able to reduce the mean dose to functional lung by 2 Gy while delivering comparable target coverage and cord/heart doses. Conclusions: 4DCT-ventilation functional avoidance clinical trials have great potential to reduce toxicity, and our data suggest that 59% of lung cancer patients have lung

Guide to clinical PET in oncology: Improving clinical management of cancer patients

International Nuclear Information System (INIS)

2008-10-01

Positron emission tomography (PET) has an approximately 50 year-history. It was developed as a tool of medical science to quantitatively measure metabolic rates of bio-substances in vivo and in particular the number of receptors in neuroscience. Until the late 1990s PET was, in most cases, research oriented activity. In 2001, positron emission tomography/X ray computed tomography (PET/CT) hybrid imaging system became commercially available. An era of clinical PET then emerged, in which PET images were utilized for clinical practice in the treatment and diagnosis of cancer patients. PET imaging could recognize areas of abnormal metabolic behaviour of cancers in vivo, and the addition of CT imaging underlines the site of malignancy. More accurate and precise interpretation of cancer lesions can therefore be performed by PET/CT imaging than PET or CT imaging alone. Clinical PET, in particular with fluorine-18-fluorodeoxyglucose ( 18 F-FDG), has already proven itself to have considerable value in oncology. The indications include malignant lymphoma and melanoma, head and neck cancers, oesophageal cancer, breast cancer, lung cancer and colorectal cancer, and it is still being expanded. The roles of clinical PET could be for 1) preoperative staging of cancers, 2) differentiation between residual tumour and scarring, 3) demonstration of suspected recurrences, 4) monitoring response to therapy, 5) prognosis and 6) radiotherapy treatment planning. Clinical PET can be used to illustrate exactly which treatment should be applied for a cancer patient as well as where surgeons should operate and where radiation oncologists should target radiation therapy. An almost exponential rise in the introduction of clinical PET, as well as the installation of PET/CT has been seen throughout the world. Clinical PET is currently viewed as the most powerful diagnostic tool in its field. This IAEA-TECDOC presents an overview of clinical PET for cancer patients and a relevant source of

Use of crowdsourcing for cancer clinical trial development.

Science.gov (United States)

Leiter, Amanda; Sablinski, Tomasz; Diefenbach, Michael; Foster, Marc; Greenberg, Alex; Holland, John; Oh, William K; Galsky, Matthew D

2014-10-01

Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct. © The Author 2014. Published by Oxford University Press. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com.

Use of biomarkers in ALS drug development and clinical trials.

Science.gov (United States)

Bakkar, Nadine; Boehringer, Ashley; Bowser, Robert

2015-05-14

The past decade has seen a dramatic increase in the discovery of candidate biomarkers for ALS. These biomarkers typically can either differentiate ALS from control subjects or predict disease course (slow versus fast progression). At the same time, late-stage clinical trials for ALS have failed to generate improved drug treatments for ALS patients. Incorporation of biomarkers into the ALS drug development pipeline and the use of biologic and/or imaging biomarkers in early- and late-stage ALS clinical trials have been absent and only recently pursued in early-phase clinical trials. Further clinical research studies are needed to validate biomarkers for disease progression and develop biomarkers that can help determine that a drug has reached its target within the central nervous system. In this review we summarize recent progress in biomarkers across ALS model systems and patient population, and highlight continued research directions for biomarkers that stratify the patient population to enrich for patients that may best respond to a drug candidate, monitor disease progression and track drug responses in clinical trials. It is crucial that we further develop and validate ALS biomarkers and incorporate these biomarkers into the ALS drug development process. This article is part of a Special Issue entitled ALS complex pathogenesis. Copyright © 2014 Elsevier B.V. All rights reserved.

Clinical features of patients developing primary hepatocellular carcinoma during anti-HBV therapy with nucleos(tide analogues

Directory of Open Access Journals (Sweden)

ZHANG Ying

2017-04-01

Full Text Available ObjectiveTo investigate the clinical features of patients developing hepatocellular carcinoma (HCC during anti-hepatitis B virus (HBV therapy with nucleos(tide analogues (NAs. MethodsA total of 542 patients who were diagnosed with HCC for the first time in The Third Affiliated Hospital of Sun Yat-Sen University from January 2008 to September 2014 were enrolled, and they all had chronic HBV infection. According to the presence or absence of standard therapy with NAs, they were divided into antiviral group (130 patients and non-antiviral group (412 patients. A retrospective analysis was performed for their clinical data, including age, sex, family history of tumor, duration of HBV infection, the time when a confirmed diagnosis of liver cirrhosis was made, history of drinking, history of diabetes, history of medication, laboratory parameters, liver pathology, and imaging findings, and these data were compared between the two groups. The t-test was used for comparison of normally distributed continuous data between groups, the Mann-Whitney U test was used for comparison of non-normally distributed continuous data between groups, and the chi-square test was used for comparison of categorical data between groups. ResultsCompared with the non-antiviral group, the antiviral group had significant increases in the proportion of patients with liver cirrhosis(90.0% vs 78.4%, χ2=8.528, P=0.003 and HBeAg-positive rate(29.4% vs 185%, χ2=6.794, P=0.009. There was a significant difference in the constitution of HBV DNA between the two groups (χ2=173.142, P＜0.001, as well as significant differences in alanine aminotransferase, gamma-glutamyl transpeptidase, and alpha-fetoprotein (all P＜0.001. Compared with the non-antiviral group, the antiviral group had a higher proportion of patients with early- or intermediate-stage liver cancer, smaller and fewer cancer lesions, and a lower proportion of patients with vascular invasion or distant metastasis (all P�

Electronic medical records in humanitarian emergencies - the development of an Ebola clinical information and patient management system.

Science.gov (United States)

Jobanputra, Kiran; Greig, Jane; Shankar, Ganesh; Perakslis, Eric; Kremer, Ronald; Achar, Jay; Gayton, Ivan

2016-01-01

By November 2015, the West Africa Ebola epidemic had caused 28598 infections and 11299 deaths in the three countries most affected. The outbreak required rapid innovation and adaptation. Médecins sans Frontières (MSF) scaled up its usual 20-30 bed Ebola management centres (EMCs) to 100-300 beds with over 300 workers in some settings. This brought challenges in patient and clinical data management resulting from the difficulties of working safely with high numbers of Ebola patients. We describe a project MSF established with software developers and the Google Social Impact Team to develop context-adapted tools to address the challenges of recording Ebola clinical information. We share the outcomes and key lessons learned in innovating rapidly under pressure in difficult environmental conditions. Information on adoption, maintenance, and data quality was gathered through review of project documentation, discussions with field staff and key project stakeholders, and analysis of tablet data. In March 2015, a full prototype was deployed in Magburaka EMC, Sierra Leone. Inpatient data were captured on 204 clinical interactions with 34 patients from 5 March until 10 April 2015. Data continued to also be recorded on paper charts, creating theoretically identical record "pairs" on paper and tablet. 83 record pairs for 33 patients with 22 data items (temperature and symptoms) per pair were analysed. The overall Kappa coefficient for agreement between sources was 0.62, but reduced to 0.59 when rare bleeding symptoms were excluded, indicating moderate to good agreement. The time taken to deliver the product was more than that anticipated by MSF (7 months versus 6 weeks). Deployment of the tablet coincided with a dramatic drop in patient numbers and thus had little impact on patient care. We have identified lessons specific to humanitarian-technology collaborative projects and propose a framework for emergency humanitarian innovation. Time and effort is required to bridge

Development of a Clinical Forecasting Model to Predict Comorbid Depression Among Diabetes Patients and an Application in Depression Screening Policy Making

OpenAIRE

Jin, Haomiao; Wu, Shinyi; Di Capua, Paul

2015-01-01

Introduction Depression is a common but often undiagnosed comorbid condition of people with diabetes. Mass screening can detect undiagnosed depression but may require significant resources and time. The objectives of this study were 1) to develop a clinical forecasting model that predicts comorbid depression among patients with diabetes and 2) to evaluate a model-based screening policy that saves resources and time by screening only patients considered as depressed by the clinical forecasting...

Development of a clinical data warehouse from an intensive care clinical information system.

Science.gov (United States)

de Mul, Marleen; Alons, Peter; van der Velde, Peter; Konings, Ilse; Bakker, Jan; Hazelzet, Jan

2012-01-01

There are relatively few institutions that have developed clinical data warehouses, containing patient data from the point of care. Because of the various care practices, data types and definitions, and the perceived incompleteness of clinical information systems, the development of a clinical data warehouse is a challenge. In order to deal with managerial and clinical information needs, as well as educational and research aims that are important in the setting of a university hospital, Erasmus Medical Center Rotterdam, The Netherlands, developed a data warehouse incrementally. In this paper we report on the in-house development of an integral part of the data warehouse specifically for the intensive care units (ICU-DWH). It was modeled using Atos Origin Metadata Frame method. The paper describes the methodology, the development process and the content of the ICU-DWH, and discusses the need for (clinical) data warehouses in intensive care. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

Developing a Tool for Increasing the Awareness about Gendered and Intersectional Processes in the Clinical Assessment of Patients--A Study of Pain Rehabilitation.

Directory of Open Access Journals (Sweden)

Anne Hammarström

Full Text Available There is a need for tools addressing gender inequality in the everyday clinical work in health care. The aim of our paper was to develop a tool for increasing the awareness of gendered and intersectional processes in clinical assessment of patients, based on a study of pain rehabilitation.In the overarching project named "Equal care in rehabilitation" we used multiple methods (both quantitative and qualitative in five sub studies. With a novel approach we used Grounded Theory in order to synthesize the results from our sub studies, in order to develop the gender equality tool. The gender equality tool described and developed in this article is thus based on results from sub studies about the processes of assessment and selection of patients in pain rehabilitation. Inspired by some questions in earlier tools, we posed open ended questions and inductively searched for findings and concepts relating to gendered and social selection processes in pain rehabilitation, in each of our sub studies. Through this process, the actual gender equality tool was developed as 15 questions about the process of assessing and selecting patients to pain rehabilitation. As a more comprehensive way of understanding the tool, we performed a final step of the GT analyses. Here we synthesized the results of the tool into a comprehensive model with two dimensions in relation to several possible discrimination axes.The process of assessing and selecting patients was visualized as a funnel, a top down process governed by gendered attitudes, rules and structures. We found that the clinicians judged inner and outer characteristics and status of patients in a gendered and intersectional way in the process of clinical decision-making which thus can be regarded as (potentially biased with regard to gender, socio-economic status, ethnicity and age.The clinical implications of our tool are that the tool can be included in the systematic routine of clinical assessment of patients

Supporting adherence and healthy lifestyles in leg ulcer patients: systematic development of the Lively Legs program for dermatology outpatient clinics.

NARCIS (Netherlands)

Heinen, M.M.; Bartholomew, L.K.; Wensing, M.J.P.; Kerkhof, P.C.M. van de; Achterberg, T. van

2006-01-01

OBJECTIVES: The objective of our project was to develop a lifestyle program for leg ulcer patients at outpatient clinics for dermatology. METHODS: We used the intervention-mapping (IM) framework for systematically developing theory and evidence based health promotion programs. We started with a

How do Patients Experience Consultations in an Outpatient AF-clinic?

DEFF Research Database (Denmark)

Thrysøe, Lars

Background / Introduction Studies indicates that patients with atrial fibrillation have a lower QoL compared to patients with other heart diseases. They meet some kind of neglect from the health society and some delay in treatment and care initiation. The interdisciplinary AF-outpatient clinic...... at Odense University Hospital, Denmark, was established marts 2012, and has in order to qualify patient treatment and care. The aim of the current project is to evaluate the clinic. Purpose / research questions How do patient and relatives experience consultations in AF-clinic? (Phase I) How do QoL develop...... over time? (Phase II) What economic consequences can be derived from the AF-clinic? (Phase III) Methods The first research question (Phase I) includes 14 patients, and will be answered by fieldwork and interviews. Afterwards, the ongoing Phase II includes 150 patients who reply the same questionnaire...

Identifying Adult Dengue Patients at Low Risk for Clinically Significant Bleeding.

Directory of Open Access Journals (Sweden)

Joshua G X Wong

Full Text Available Clinically significant bleeding is important for subsequent optimal case management in dengue patients, but most studies have focused on dengue severity as an outcome. Our study objective was to identify differences in admission parameters between patients who developed clinically significant bleeding and those that did not. We sought to develop a model for discriminating between these patients.We conducted a retrospective study of 4,383 adults aged >18 years who were hospitalized with dengue infection at Tan Tock Seng Hospital, Singapore from 2005 to 2008. Patients were divided into those with clinically significant bleeding (n = 188, and those without (n = 4,195. Demographic, clinical, and laboratory variables on admission were compared between groups to determine factors associated with clinically significant bleeding during hospitalization.On admission, female gender (p38°C (p38°C (aOR 1.81; 95% CI: 1.27-2.61, nausea/vomiting (aOR 1.39; 95% CI: 0.94-2.12, ANC (aOR 1.3; 95% CI: 1.15-1.46, ALC (aOR 0.4; 95% CI: 0.25-0.64, hematocrit percentage (aOR 0.96; 95% CI: 0.92-1.002 and platelet count (aOR 0.993; 95% CI: 0.988-0.998. At the cutoff of -3.919, the model achieved an AUC of 0.758 (sensitivity:0.87, specificity: 0.38, PPV: 0.06, NPV: 0.98.Clinical risk factors associated with clinically significant bleeding were identified. This model may be useful to complement clinical judgement in triaging adult dengue patients given the dynamic nature of acute dengue, particularly in pre-identifying those less likely to develop clinically significant bleeding.

Non-clinical development of CER-001.

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Barbaras, Ronald

2015-01-01

Cardiovascular disease remains the most pressing healthcare issue for the developed world and is becoming so for developing countries. There are no currently approved therapies that can rapidly reduce the burden of unstable, inflamed plaque in the overall coronary vascular bed. High-density lipoprotein (HDL) has multiple actions that could lead to plaque stabilization, such as rapid removal of large quantities of cholesterol from the vasculature through the process of reverse lipid transport, improvement in endothelial function, protection against oxidative damage, and reduction in inflammation. Short-term infusion of HDL-mimetics in animal models as well as in humans has shown promising effects on the plaque size and morphology. Cerenis Therapeutics has developed CER-001, a negatively charged lipoprotein complex consisting of phospholipid and recombinant human apoA-I that mimics the structure and function of natural HDL. Three clinical trials using CER-001 infusions have demonstrated improvements in the carotid wall thickness of patients with familial hypercholesterolaemia and in patients with hypo-alphalipoproteinaemia, as well as an impact on coronary plaque burden measured by intravascular ultrasonography at the lowest tested dose (3 mg/kg) in post-ACS patients. Here, we reviewed the non-clinical data leading to the demonstration that CER-001 is a full HDL mimetic.

Clinical findings in 16 patients with tomographic diagnosis of schizencephaly

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Rodrigues, Maria do Carmo de Souza [Universidade Federal do Espirito Santo, Vitoria, ES (Brazil). Hospital Universitario Cassiano Antonio Moraes]. E-mail: rodriguesmcs@yahoo.com.br; Monteiro, Alexandra Maria Vieira [Universidade do Estado do Rio de Janeiro, RJ (Brazil). Faculdade de Ciencias Medicas; Llerena Junior, Juan Clinton [Fundacao Oswaldo Cruz, Rio de Janeiro, RJ (Brazil). Instituto Fernandes Figueira. Centro de Genetica Medica; Fernandes, Alexandre Ribeiro [Universidade Gama Filho, Rio de Janeiro, RJ (Brazil). Dept. de Pediatria

2006-09-15

Objective: to establish a correlation between clinical features in a group of children with tomographic diagnosis of schizencephaly and clefts extent and localization. Materials and methods: retrospective study of dossiers from the archives of Neurology and Medical Genetics Services at Instituto Fernandes Figueira/FIOCRUZ and Hospital Municipal Jesus, Rio de Janeiro, RJ, Brazil, in the period between 2000 and 2003. The study included 16 patients, nine female and seven male, with tomographic diagnosis of schizencephaly investigated for clinical findings, psychomotor development, motor/cognitive deficits and epilepsy. Results: predominance of bilateral clefts in 10:16 patients, open-lip schizencephaly type in 23:27 patients, and small lips in 11:27 patients. As regards anomalies associated with schizencephaly, pellucid septum absence was the most frequent one (10:16 patients). As regards clinical findings, 15 patients presented with developmental delay and motor deficit, six patients with cognitive deficit and ten with epilepsy. In three patients, we observed discordant clinical findings and cleft sizes, although the clefts were small, the clinical features severity was high because of other cerebral anomalies. Conclusion: the clinical features of schizencephaly are related to the size of the clefts, regardless laterality, presenting higher severity when associated with other cerebral anomalies. (author)

Clinical findings in 16 patients with tomographic diagnosis of schizencephaly

International Nuclear Information System (INIS)

Rodrigues, Maria do Carmo de Souza; Monteiro, Alexandra Maria Vieira; Llerena Junior, Juan Clinton; Fernandes, Alexandre Ribeiro

2006-01-01

Objective: to establish a correlation between clinical features in a group of children with tomographic diagnosis of schizencephaly and clefts extent and localization. Materials and methods: retrospective study of dossiers from the archives of Neurology and Medical Genetics Services at Instituto Fernandes Figueira/FIOCRUZ and Hospital Municipal Jesus, Rio de Janeiro, RJ, Brazil, in the period between 2000 and 2003. The study included 16 patients, nine female and seven male, with tomographic diagnosis of schizencephaly investigated for clinical findings, psychomotor development, motor/cognitive deficits and epilepsy. Results: predominance of bilateral clefts in 10:16 patients, open-lip schizencephaly type in 23:27 patients, and small lips in 11:27 patients. As regards anomalies associated with schizencephaly, pellucid septum absence was the most frequent one (10:16 patients). As regards clinical findings, 15 patients presented with developmental delay and motor deficit, six patients with cognitive deficit and ten with epilepsy. In three patients, we observed discordant clinical findings and cleft sizes, although the clefts were small, the clinical features severity was high because of other cerebral anomalies. Conclusion: the clinical features of schizencephaly are related to the size of the clefts, regardless laterality, presenting higher severity when associated with other cerebral anomalies. (author)

Clinical characteristics and treatment outcomes of patients with colorectal cancer who develop brain metastasis: a single institution experience.

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Fountzilas, Christos; Chang, Katherine; Hernandez, Brian; Michalek, Joel; Crownover, Richard; Floyd, John; Mahalingam, Devalingam

2017-02-01

The development of brain metastasis (BM) in patients with colorectal cancer (CRC) is a rare and late event. We sought to investigate the clinical characteristics, disease course and safety using biologic agents in our patients with CRC who develop brain metastases. A retrospective review of patients with CRC with brain metastases treated at our institution from 01/2005-01/2015 was performed. Survival analysis was performed using the Kaplan-Meier method. Forty patients were included in the analysis. Median age was 55.5 years, 67.5% were males, and 28% had a KRAS mutation. Twenty-four percent were treatment-naive at the time of BM diagnosis. Patients had a median of two brain lesions. Sixty-five percent of the patients were treated with radiotherapy alone, 22.5% had both surgical resection and brain radiotherapy. Median overall survival was 3.2 months after development of BM. Overall survival was longer in patients who received combined modality local therapy compared to patients treated with surgical resection or radiotherapy alone. Patients who received systemic treatment incorporating biologics following development of BM had a median overall survival of 18.6 months. Overall, the administration of biologic agents was safe and well tolerated. In summary, BM is an uncommon and late event in the natural history of metastatic CRC. The ability to deliver combined-modality local brain therapy as well as availability of more systemic therapy options appear to lead to improved outcomes.

A nurse-led clinic for patients consulting with osteoarthritis in general practice: development and impact of training in a cluster randomised controlled trial.

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Healey, Emma L; Main, Chris J; Ryan, Sarah; McHugh, Gretl A; Porcheret, Mark; Finney, Andrew G; Morden, Andrew; Dziedzic, Krysia S

2016-12-21

Despite a lack of service provision for people with osteoarthritis (OA), each year 1 in 5 of the general population consults a GP about a musculoskeletal condition such as OA. Consequently this may provide an opportunity for practice nurses to take an active role in helping patients manage their condition. A nurse led clinic for supporting patients with OA was developed for the MOSAICS study investigating how to implement the NICE 2014 OA Guideline core recommendations. This paper has two main objectives, firstly to provide an overview of the nurse-led OA clinic, and secondly to describe the development, key learning objectives, content and impact of the training to support its delivery. A training programme was developed and delivered to provide practice nurses with the knowledge and skill set needed to run the nurse-led OA clinic. The impact of the training programme on knowledge, confidence and OA management was evaluated using case report forms and pre and post training questionnaires. The pre-training questionnaire identified a gap between what practice nurses feel they can do and what they should be doing in line with NICE OA guidelines. Evaluation of the training suggests that it enabled practice nurses to feel more knowledgeable and confident in supporting patients to manage their OA and this was reflected in the clinical management patients received in the nurse-led OA clinics. A significant gap between what is recommended and what practice nurses feel they can currently provide in terms of OA management was evident. The development of a nurse training programme goes some way to develop a system in primary care for delivering the core recommendations by NICE. The cluster trial linked to this training was conducted from May 2012 through February 2014 by the Arthritis Research UK Primary Care Centre, Keele University, UK (Trial registration number ISRCTN06984617 ).

Educational effects using a robot patient simulation system for development of clinical attitude.

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Abe, S; Noguchi, N; Matsuka, Y; Shinohara, C; Kimura, T; Oka, K; Okura, K; Rodis, O M M; Kawano, F

2017-11-01

The aim of this study was to assess the effectiveness of improving the attitude of dental students towards the use of a full-body patient simulation system (SIMROID) compared to the traditional mannequin (CLINSIM) for dental clinical education. The participants were 10 male undergraduate dental students who had finished clinical training in the university hospital 1 year before this study started. They performed a crown preparation on an upper pre-molar tooth using SIMROID and CLINSIM as the practical clinical trials. The elapsed time for preparation was recorded. The taper of the abutment teeth was measured using a 3-dimensional shape-measuring device after this trial. In addition, a self-reported questionnaire was collected that included physical pain, treatment safety and maintaining a clean area for each simulator. Qualitative data analysis of a free format report about SIMROID was performed using text mining analysis. This trial was performed twice at 1-month intervals. The students considered physical pain, treatment safety and a clean area for SIMROID significantly better than that for CLINSIM (P mining analysis, most of the students wrote that SIMROID was similar to real patients. The use of SIMROID was proven to be effective in improving the attitude of students towards patients, thereby giving importance to considerations for actual patients during dental treatment. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A nurse- and pharmacist-led treatment advice clinic for patients attending an HIV outpatient clinic.

Science.gov (United States)

Griffiths, C; Miles, K; Aldam, D; Cornforth, D; Minton, J; Edwards, S; Williams, I

2007-05-01

This paper is a report of a study to map care pathways, examine the approach of different treatment advisors and explore the acceptability of a nurse- and pharmacist-led treatment advice clinic in order to aid decision-making for the future development and evaluation of the clinic. High levels of adherence to antiretroviral drugs are a prerequisite for a successful and durable virological and immunological response to HIV. Treatment guidelines acknowledge that adherence is a process, not a single event, and that adherence support must be integrated into clinical follow-up for all patients receiving these drugs. Data were collected between September 2004 and January 2005 through 17 consultation observations and 10 patient interviews in a specialist treatment advice clinic located within a central London HIV outpatient clinic providing care for over 2200 patients, of whom more than 1300 are taking highly active antiretroviral therapy. The nurses and pharmacist had similar consultation approaches, although follow-up care varied in extent. Benefits of the clinic approach included permitting patients to observe real tablets, tailoring regimens to lifestyles and telephone follow-up. These factors, particularly telephone support, were perceived by patients to assist with adherence. The role of telephone support, perceived to assist with initial adherence, requires further investigation. Future work is also needed to explore the health economics of this approach and to determine the actual impact of the clinic on clinical and adherence outcomes.

Patients' Experiences With Vehicle Collision to Inform the Development of Clinical Practice Guidelines: A Narrative Inquiry.

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Lindsay, Gail M; Mior, Silvano A; Côté, Pierre; Carroll, Linda J; Shearer, Heather M

2016-01-01

The purpose of this narrative inquiry was to explore the experiences of persons who were injured in traffic collisions and seek their recommendations for the development of clinical practice guideline (CPG) for the management of minor traffic injuries. Patients receiving care for traffic injuries were recruited from 4 clinics in Ontario, Canada resulting in 11 adult participants (5 men, 6 women). Eight were injured while driving cars, 1 was injured on a motorcycle, 2 were pedestrians, and none caused the collision. Using narrative inquiry methodology, initial interviews were audiotaped, and follow-up interviews were held within 2 weeks to extend the story of experience created from the first interview. Narrative plotlines across the 11 stories were identified, and a composite story inclusive of all recommendations was developed by the authors. The research findings and composite narrative were used to inform the CPG Expert Panel in the development of new CPGs. Four recommended directions were identified from the narrative inquiry process and applied. First, terminology that caused stigma was a concern. This resulted in modified language ("injured persons") being adopted by the Expert Panel, and a new nomenclature categorizing layers of injury was identified. Second, participants valued being engaged as partners with health care practitioners. This resulted in inclusion of shared decision-making as a foundational recommendation connecting CPGs and care planning. Third, emotional distress was recognized as a factor in recovery. Therefore, the importance of early detection and the ongoing evaluation of risk factors for delayed recovery were included in all CPGs. Fourth, participants shared that they were unfamiliar with the health care system and insurance industry before their accident. Thus, repeatedly orienting injured persons to the system was advised. A narrative inquiry of 11 patients' experiences with traffic collision and their recommendations for clinical

The patient perspective of clinical training-an empirical study about patient motives to participate.

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Drevs, Florian; Gebele, Christoph; Tscheulin, Dieter K

2014-10-01

This study introduces a comprehensive model to explain patients' prosocial behavioral intentions to participate in clinical training. Using the helping decision model, the authors analyze the combined impact of factors that affect participation intentions. The model includes intrapersonal and interpersonal appraisals triggered by an awareness of the societal need for clinical training as a practical part of medical education. The results of our empirical study (N=317) show that personal costs and anxiety as negative appraisals and a warm glow as a positive appraisal affect participation intentions and fully mediate the effect of the patient's awareness of the societal need. The study results indicate that communication strategies should address patient beliefs about negative personal consequences of participation rather than highlighting the societal need for practical medical education related to clinical training. Based on the results, medical associations could develop guidelines and provide training for physicians on how to motivate patients to participate in clinical training, resulting in more patient-centered standardized consent discussions. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Just-in-time patient scheduling in an eye care clinic

NARCIS (Netherlands)

Blake, J.; Campbell, Matthew; Vanberkel, Peter T.

2007-01-01

The IWK’s division of Ophthalmology currently provides clinical service to over 8000 patients per year. Eye Care Centre patients were experiencing long waits between registration and their ophthalmologist appointment. This paper details the development of a patient scheduling methodology that

How to Develop a Cardio-Oncology Clinic.

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Snipelisky, David; Park, Jae Yoon; Lerman, Amir; Mulvagh, Sharon; Lin, Grace; Pereira, Naveen; Rodriguez-Porcel, Martin; Villarraga, Hector R; Herrmann, Joerg

2017-04-01

Cardiovascular demands to the care of cancer patients are common and important given the implications for morbidity and mortality. As a consequence, interactions with cardiovascular disease specialists have intensified to the point of the development of a new discipline termed cardio-oncology. As an additional consequence, so-called cardio-oncology clinics have emerged, in most cases staffed by cardiologists with an interest in the field. This article addresses this gap and summarizes key points in the development of a cardio-oncology clinic. Copyright © 2017 Elsevier Inc. All rights reserved.

Development of a cancer clinical trials multi-media intervention: clinical trials: are they right for you?

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Wells, Kristen J; Quinn, Gwendolyn P; Meade, Cathy D; Fletcher, Michelle; Tyson, Dinorah Martinez; Jim, Heather; Jacobsen, Paul B

2012-08-01

To describe processes used to develop a multi-media psycho-educational intervention to prepare patients for a discussion about cancer clinical trials (CTs). Guided by a Steering Committee, formative research was conducted to develop an informative and engaging tool about cancer CTs. Twenty-three patients and caregivers participated in formative in-depth interviews to elicit information about perceptions of cancer CTs to inform production of a new media product. Formative research revealed participants had concerns about experimentation, held beliefs that cancer CTs were for patients who had no other treatment options, and wanted a balance of information about pros and cons of CT participation. The value of physicians as credible spokespersons and the use of patients as role-models were supported. Using iterative processes, the production team infused the results into creation of a multimedia psycho-educational intervention titled Clinical Trials: Are they Right for You? An intervention, developed through an iterative consumer-focused process involving multiple stakeholders and formative research, may result in an engaging informative product. If found to be efficacious, Clinical Trials: Are they Right for You? is a low-cost and easily disseminated multimedia psycho-educational intervention to assist cancer patients with making an informed decision about cancer CTs. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Clinical use of patient decision-making aids for stone patients.

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Lim, Amy H; Streeper, Necole M; Best, Sara L; Penniston, Kristina L; Nakada, Stephen Y

2017-08-01

Patient decision-making aids (PDMAs) help patients make informed healthcare decisions and improve patient satisfaction. The utility of PDMAs for patients considering treatments for urolithiasis has not yet been published. We report our experience using PDMAs developed at our institution in the outpatient clinical setting in patients considering a variety of treatment options for stones. Patients with radiographically confirmed urolithiasis were given PDMAs regarding treatment options for their stone(s) based on their clinical profile. We assessed patients' satisfaction, involvedness, and feeling of making a more informed decision with utilization of the PDMAs using a Likert Scale Questionnaire. Information was also collected regarding previous stone passage, history and type of surgical intervention for urolithiasis, and level of education. Patients (n = 43; 18 males, 23 females and two unknown) 53 +/- 14years old were included. Patients reported that they understood the advantages and disadvantages outlined in the PDMAs (97%), that the PDMAs helped them make a more informed decision (83%) and felt more involved in the decision making process (88%). Patients reported that the aids were presented in a balanced manner and used up-to-date scientific information (100%, 84% respectively). Finally, a majority of the patients prefer an expert's opinion when making a treatment decision (98%) with 73% of patients preferring to form their own opinion based on available information. Previous stone surgery was associated with patients feeling more involved with the decision making process (p = 0.0465). PDMAs have a promising role in shared decision-making in the setting of treatment options for nephrolithiasis.

A novel 1050nm handheld OCT imaging system for pediatric retinoblastoma patients: technology development and clinical study (Conference Presentation)

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Nadiarnykh, Oleg; Moll, Annette C.; de Boer, Johannes F.

2016-03-01

We demonstrate a novel optical coherence tomography system specifically developed and validated for clinical imaging of retinoblastoma tumors in pediatric patients. The existing treatment options for this malignant tumor of the retina aim at reduction of tumor (re)growth risks, and vision preservation. The choice of optimal treatment strongly depends on skilled and detailed clinical assessment. Due to the limitations of the existing real-time diagnostic tools the patients at risk are periodically monitored with retinal imaging to confirm the absence of new tumor seedings. Three-dimensional visualization of tissue layer and microvasculature at improved axial and lateral resolution of interference-based OCT imaging provides sensitivity for detection of vital tumor tissue concurrent with local treatment. Our METC-approved system accommodates for the range of optical parameters of infants' eyes, and uses the 1050nm wavelength to access the deeper choroid layers of retina. The prototype is designed for patients in supine position under general anesthesia, where ergonomic handheld module is connected to fiber-based optical setup via umbilical cord. The system conforms to clinical safety requirements, including fully isolated low-voltage electric circuit. Focusing is performed with a mechanically tunable lens, where resolution is 6 µm axially, and varies with focusing at 10-18µm laterally. We will present optical design, performance limitations, and results of the ongoing clinical study, including the increased OCT diagnostic sensitivity in three dimensions in comparison with the established clinical imaging modalities. We will discuss images of early, active, and treated tumors, as well as follow-up on patients after local and systemic treatments.

Clinical Chemistry of Patients With Ebola in Monrovia, Liberia.

Science.gov (United States)

de Wit, Emmie; Kramer, Shelby; Prescott, Joseph; Rosenke, Kyle; Falzarano, Darryl; Marzi, Andrea; Fischer, Robert J; Safronetz, David; Hoenen, Thomas; Groseth, Allison; van Doremalen, Neeltje; Bushmaker, Trenton; McNally, Kristin L; Feldmann, Friederike; Williamson, Brandi N; Best, Sonja M; Ebihara, Hideki; Damiani, Igor A C; Adamson, Brett; Zoon, Kathryn C; Nyenswah, Tolbert G; Bolay, Fatorma K; Massaquoi, Moses; Sprecher, Armand; Feldmann, Heinz; Munster, Vincent J

2016-10-15

The development of point-of-care clinical chemistry analyzers has enabled the implementation of these ancillary tests in field laboratories in resource-limited outbreak areas. The Eternal Love Winning Africa (ELWA) outbreak diagnostic laboratory, established in Monrovia, Liberia, to provide Ebola virus and Plasmodium spp. diagnostics during the Ebola epidemic, implemented clinical chemistry analyzers in December 2014. Clinical chemistry testing was performed for 68 patients in triage, including 12 patients infected with Ebola virus and 18 infected with Plasmodium spp. The main distinguishing feature in clinical chemistry of Ebola virus-infected patients was the elevation in alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, and γ-glutamyltransferase levels and the decrease in calcium. The implementation of clinical chemistry is probably most helpful when the medical supportive care implemented at the Ebola treatment unit allows for correction of biochemistry derangements and on-site clinical chemistry analyzers can be used to monitor electrolyte balance. Published by Oxford University Press for the Infectious Diseases Society of America 2016. This work is written by (a) US Government employee(s) and is in the public domain in the US.

Pressure Ulcers: Developing Clinical Indicators in Evidence-based Practice. A Prospective Study.

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Tsaras, Konstantinos; Chatzi, Maria; Kleisiaris, Christos F; Fradelos, Evangelos C; Kourkouta, Lambrini; Papathanasiou, Ioanna V

2016-10-01

It is widely recognized that Intensive Care Unit (ICU) patients have a greater likelihood of developing pressure ulcers in comparison to hospital or home care patients. Accordingly, this study aimed to evaluate whether specific clinical characteristics could be used as clinical indicators towards pressure ulcers prevention. We monitored 210 hospitalized ICU patients during a 12-month period. Pressure ulcers were assessed following the current guidelines. Clinical characteristics such as gender, age, hospitalized days, hemodialysis treatment, hematocrit, and serum albumin levels were considered as the most common predictors for pressure ulcers development. The significance of associations was controlled using multiple logistic regression after adjusting for clinical characteristics and was presented as adjusted odds ratio (AOR). The prevalence of pressure ulcers was 24.3%. Logistic regression revealed that patients with increased age AOR=1.04; (CI: 1.01-1.07) and last-long hospitalization AOR=1.17; (CI: 1.11-1.23) were significantly more likely to present pressure ulcers compared to the younger ones and patients with less length of stay, respectively. We also found that patients under hemodialysis treatment were more likely to present pressure ulcers AOR=4.09; (CI: 1.12-14.98) compared to patients that did not underwent hemodialysis and the risk of pressure ulcers development was decreased by 9% for every single unit of hematocrit value increase AOR=0.91; (CI: 0.82-0.99). Our data analysis confirms that the clinical characteristics that were studied are independently associated with pressure ulcers development, and therefore, it is a crucial incentive to consider that these specific clinical characteristics are important indicators in the evidence-based practice.

A Leadership Education and Development Program for Clinical Nurses.

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Fitzpatrick, Joyce J; Modic, Mary Beth; Van Dyk, Jennifer; Hancock, K Kelly

2016-11-01

The Leadership Education and Development (LEAD) Program was designed to transform care at the bedside by empowering clinical nurses as leaders. The heart of LEAD was enhancing communication skills of clinical nurses with clinical colleagues and, most importantly, patients and families. Key concepts of leadership/management were included: personal awareness, personal leadership skills/abilities, leading change, leading others individually and in teams, enhancing the patient/provider experience, and the leadership role in outcomes management. A quantitative, longitudinal, survey design was used with 2 cohorts. The program consisted of six 4-hour sessions for 3 to 6 months. Leadership practices were measured before program implementation, at the end of the program, and 3 months after program completion. There were significant increases in leadership practices sustained 3 months after program completion. A range of other outcome measures was included. There is a need for additional leadership development programs for clinical nurses.

Development of a Clinical Tool to Predict Home Death of a Discharged Cancer Patient in Japan: a Case-Control Study.

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Fukui, Sakiko; Morita, Tatsuya; Yoshiuchi, Kazuhiro

2017-08-01

The aim of this study was to investigate the predictive value of a clinical tool to predict whether discharged cancer patients die at home, comparing groups of case who died at home and control who died in hospitals or other facilities. We conducted a nationwide case-control study to identify the determinants of home death for a discharged cancer patient. We randomly selected nurses in charge of 2000 home-visit nursing agencies from all 5813 agencies in Japan by referring to the nationwide databases in January 2013. The nurses were asked to report variables of their patients' place of death, patients' and caregivers' clinical statuses, and their preferences for home death. We used logistic regression analysis and developed a clinical tool to accurately predict it and investigated their predictive values. We identified 466 case and 478 control patients. Five predictive variables of home death were obtained: patients' and caregivers' preferences for home death [OR (95% CI) 2.66 (1.99-3.55)], availability of visiting physicians [2.13 (1.67-2.70)], 24-h contact between physicians and nurses [1.68 (1.30-2.18)], caregivers' experiences of deathwatch at home [1.41 (1.13-1.75)], and patients' insights as to their own prognosis [1.23 (1.02-1.50)]. We calculated the scores predicting home death for each variable (range 6-28). When using a cutoff point of 16, home death was predicted with a sensitivity of 0.72 and a specificity of 0.81 with the Harrell's c-statistic of 0.84. This simple clinical tool for healthcare professionals can help predict whether a discharged patient is likely to die at home.

Clinical diagnostic model for sciatica developed in primary care patients with low back-related leg pain

Science.gov (United States)

Konstantinou, Kika; Ogollah, Reuben; Hay, Elaine M.; Dunn, Kate M.

2018-01-01

Background Identification of sciatica may assist timely management but can be challenging in clinical practice. Diagnostic models to identify sciatica have mainly been developed in secondary care settings with conflicting reference standard selection. This study explores the challenges of reference standard selection and aims to ascertain which combination of clinical assessment items best identify sciatica in people seeking primary healthcare. Methods Data on 394 low back-related leg pain consulters were analysed. Potential sciatica indicators were seven clinical assessment items. Two reference standards were used: (i) high confidence sciatica clinical diagnosis; (ii) high confidence sciatica clinical diagnosis with confirmatory magnetic resonance imaging findings. Multivariable logistic regression models were produced for both reference standards. A tool predicting sciatica diagnosis in low back-related leg pain was derived. Latent class modelling explored the validity of the reference standard. Results Model (i) retained five items; model (ii) retained six items. Four items remained in both models: below knee pain, leg pain worse than back pain, positive neural tension tests and neurological deficit. Model (i) was well calibrated (p = 0.18), discrimination was area under the receiver operating characteristic curve (AUC) 0.95 (95% CI 0.93, 0.98). Model (ii) showed good discrimination (AUC 0.82; 0.78, 0.86) but poor calibration (p = 0.004). Bootstrapping revealed minimal overfitting in both models. Agreement between the two latent classes and clinical diagnosis groups defined by model (i) was substantial, and fair for model (ii). Conclusion Four clinical assessment items were common in both reference standard definitions of sciatica. A simple scoring tool for identifying sciatica was developed. These criteria could be used clinically and in research to improve accuracy of identification of this subgroup of back pain patients. PMID:29621243

Development of acromegaly in patients with prolactinomas

DEFF Research Database (Denmark)

Andersen, Marianne; Hagen, Casper; Frystyk, Jan

2003-01-01

OBJECTIVES: Patients with prolactinomas and patients with acromegaly often have heterogenous adenomas. In this study we have focused on patients with prolactinomas who developed acromegaly and acromegalic patients with hyperprolactinaemia. Our hypothesis is that some patients with hyperprolactina......OBJECTIVES: Patients with prolactinomas and patients with acromegaly often have heterogenous adenomas. In this study we have focused on patients with prolactinomas who developed acromegaly and acromegalic patients with hyperprolactinaemia. Our hypothesis is that some patients...... with hyperprolactinaemia may develop clinical acromegaly. METHODS: We have included patients examined at department M, Odense University Hospital between 1996 and 2001. Seventy-eight patients with prolactinomas, 65 females and 13 males, with a median age (range) of 30 Years (14-74) and 47 Years (20-66), respectively, were...

Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review.

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de Jong, Marin J; Huibregtse, Roxanne; Masclee, Ad A M; Jonkers, Daisy M A E; Pierik, Marie J

2018-05-01

Mucosal inflammation must be carefully monitored to improve the long-term outcomes of patients with inflammatory bowel diseases (IBD). Patient-reported outcome measures (PROMs) are used increasingly to monitor disease activity in clinical practice and as endpoints in clinical trials. We performed a systematic review to provide an overview of the available PROMs on IBD activity and to evaluate their diagnostic value. A systematic search of the PubMed, Medline, Cochrane library, and Embase databases using defined keywords, identified 973 articles. These were screened by 2 independent reviewers, and 37 articles on development or validation of PROMs to assess IBD activity were identified for further analysis. Based on the recommendations of the Food and Drug Administration (FDA), the following measurement properties were evaluated: content, construct, and criterion validity; reliability; and responsiveness to change. In addition, data on ease of use in clinical practice were collected. Seventeen articles presenting 20 different PROMs were included the final analysis, although none met all the FDA-recommended criteria. Only 2 PROMs (patient-reported Harvey Bradshaw Index and Simple Clinical Colitis Activity Index scores) reported patient involvement during its development. Only 6 PROMs (patient-reported global assessment, patient assessment of disease activity, mobile health index for Crohn's disease, mobile health index for ulcerative colitis, patient-reported outcome derived from the Mayo score, and the 6-point Mayo score) were validated as markers of IBD activity, using findings from endoscopy as the reference standard; these PROMs identified patients with mucosal inflammation with area under the curve values of 0.63-0.82. The mobile health index for CD and UC scores had the best measurement properties for use in clinical practice and in clinical trials. In a systematic review, we identified more than 20 PROMS that have been developed and tested for their ability to

Development, external validation and clinical usefulness of a practical prediction model for radiation-induced dysphagia in lung cancer patients

International Nuclear Information System (INIS)

Dehing-Oberije, Cary; De Ruysscher, Dirk; Petit, Steven; Van Meerbeeck, Jan; Vandecasteele, Katrien; De Neve, Wilfried; Dingemans, Anne Marie C.; El Naqa, Issam; Deasy, Joseph; Bradley, Jeff; Huang, Ellen; Lambin, Philippe

2010-01-01

Introduction: Acute dysphagia is a distressing dose-limiting toxicity occurring frequently during concurrent chemo-radiation or high-dose radiotherapy for lung cancer. It can lead to treatment interruptions and thus jeopardize survival. Although a number of predictive factors have been identified, it is still not clear how these could offer assistance for treatment decision making in daily clinical practice. Therefore, we have developed and validated a nomogram to predict this side-effect. In addition, clinical usefulness was assessed by comparing model predictions to physicians' predictions. Materials and methods: Clinical data from 469 inoperable lung cancer patients, treated with curative intent, were collected prospectively. A prediction model for acute radiation-induced dysphagia was developed. Model performance was evaluated by the c-statistic and assessed using bootstrapping as well as two external datasets. In addition, a prospective study was conducted comparing model to physicians' predictions in 138 patients. Results: The final multivariate model consisted of age, gender, WHO performance status, mean esophageal dose (MED), maximum esophageal dose (MAXED) and overall treatment time (OTT). The c-statistic, assessed by bootstrapping, was 0.77. External validation yielded an AUC of 0.94 on the Ghent data and 0.77 on the Washington University St. Louis data for dysphagia ≥ grade 3. Comparing model predictions to the physicians' predictions resulted in an AUC of 0.75 versus 0.53, respectively. Conclusions: The proposed model performed well was successfully validated and demonstrated the ability to predict acute severe dysphagia remarkably better than the physicians. Therefore, this model could be used in clinical practice to identify patients at high or low risk.

Simulating clinical trial visits yields patient insights into study design and recruitment

Directory of Open Access Journals (Sweden)

Lim SS

2017-07-01

Full Text Available S Sam Lim,1 Alan J Kivitz,2 Doug McKinnell,3 M Edward Pierson,4 Faye S O’Brien4 1Division of Rheumatology, Department of Medicine, Emory University, Atlanta, GA, USA; 2Altoona Center for Clinical Research, Altoona, PA, USA; 3Deloitte Life Sciences Advisory, Basel, Switzerland; 4Clinical Operations, Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA Purpose: We elicited patient experiences from clinical trial simulations to aid in future trial development and to improve patient recruitment and retention.Patients and methods: Two simulations of draft Phase II and Phase III anifrolumab studies for systemic lupus erythematosus (SLE/lupus nephritis (LN were performed involving African-American patients from Grady Hospital, an indigent care hospital in Atlanta, GA, USA, and white patients from Altoona Arthritis and Osteoporosis Center in Altoona, PA, USA. The clinical trial simulation included an informed consent procedure, a mock screening visit, a mock dosing visit, and a debriefing period for patients and staff. Patients and staff were interviewed to obtain sentiments and perceptions related to the simulated visits.Results: The Atlanta study involved 6 African-American patients (5 female aged 27–60 years with moderate to severe SLE/LN. The Altoona study involved 12 white females aged 32–75 years with mild to moderate SLE/LN. Patient experiences had an impact on four patient-centric care domains: 1 information, communication, and education; 2 responsiveness to needs; 3 access to care; and 4 coordination of care; and continuity and transition. Patients in both studies desired background material, knowledgeable staff, family and friend support, personal results, comfortable settings, shorter wait times, and greater scheduling flexibility. Compared with the Altoona study patients, Atlanta study patients reported greater preferences for information from the Internet, need for strong community and online support, difficulties in

[Development of a clinical pathway for the attention of patients with amyotrophic lateral sclerosis in a regional network. ALS Assistance Network-Comunidad de Madrid].

Science.gov (United States)

Rodríguez de Rivera, F J; Grande, M; García-Caballero, J; Muñoz-Blanco, J; Mora, J; Esteban, J; Guerrero, A; Matias-Guiu, J; de Andrés-Colsa, R; Buey, C; Díez-Tejedor, E

2007-01-01

Amyotrophic lateral sclerosis (ALS) requires complex multidisciplinary attention. Clinical pathways are assistance plans for certain diseases with a predictable course. These plans are established in isolated centers, not in multicenter regions. The aim is to develop a clinical pathway capable of organizing and homogenizing assistance given in ALS Assistance Network-Comunidad de Madrid which is made up of five hospitals, from the beginning until the end of the disease. In successive meetings, neurologists of these hospitals and members of the Madrid Health Service evaluated published therapeutic guidelines and other documents used in ALS assistance. A clinical pathway was developed adapting this information to social-health care conditions in the Comunidad de Madrid following the FOCUS-PDCA model. A clinical pathway was created consisting of a scientist-technical framework which arranges the attention in relationship to the diagnosis and treatment, according to the degree of disease progression and a chronogram. This is accompanied by several patient information documents on the disease and the tests that are required, and a patient assistance evaluation form. The standards are established to reach and to promote 354 constant improvement in patient care. Clinical pathway for the ALS assistance in a regional network organizes the attention and cares that the patients must receive from the beginning to the end of the disease. This arrangement and homogenization of the attention improves the quality of patient care, diminishes variability and rationalizes the use of the health care resources.

Patient recognition of recrudescent herpes labialis: a clinical and virological assessment.

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Lamey, P J; Biagioni, P A

1996-09-01

The purpose of this study was to ascertain how accurate the general public was at diagnosing the condition of recrudescent herpes labialis. An advertisement was placed in a local newspaper inviting patients to attend the Oral Medicine Clinic as soon as they thought they developed the clinically evident stage of herpes labialis. At the clinic, patients were examined to confirm the clinical presence of herpes labialis and also had a swab of the lesion(s) taken for virus culture. Virus culture was by the HEP-2 culture technique capable of detecting both herpes simplex Type 1 and herpes simplex Type 2. Patients also completed a detailed questionnaire concerning their knowledge of herpes labialis. In total, 41 patients attended for screening. The findings were that all patients had clinical herpes labialis, and herpes simplex virus was isolated in 96% of cases. In contrast, in only about 50% of cases were patients aware that their herpes labialis was caused by a virus. The general public are very good at recognizing herpes labialis lesions but need to be given more information about their infectivity.

Patient safety and quality of care: how may clinical simulation contribute?

DEFF Research Database (Denmark)

Jensen, Sanne

2015-01-01

The usability of health information technology (IT) is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector...... influences the development and application of health IT. When health IT is introduced in local clinical work practices, potential patient safety hazards and insufficient support of work practices need to be examined. Qualitative methods, such as clinical simulation, may be used to evaluate new technology...

Optimizing the patient transport function at Mayo Clinic.

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Kuchera, Dustin; Rohleder, Thomas R

2011-01-01

In this article, we report on the implementation of a computerized scheduling tool to optimize staffing for patient transport at the Mayo Clinic. The tool was developed and implemented in Microsoft Excel and Visual Basic for Applications and includes an easy-to-use interface. The tool allows transport management to consider the trade-offs between patient waiting time and staffing levels. While improved staffing efficiency was a desire of the project, it was important that patient service quality was also maintained. The results show that staffing could be reduced while maintaining historical patient service levels.

Patient Engagement Practices in Clinical Research among Patient Groups, Industry, and Academia in the United States: A Survey.

Directory of Open Access Journals (Sweden)

Sophia K Smith

Full Text Available Patient-centered clinical trial design and execution is becoming increasingly important. No best practice guidelines exist despite a key stakeholder declaration to create more effective engagement models. This study aims to gain a better understanding of attitudes and practices for engaging patient groups so that actionable recommendations may be developed.Individuals from industry, academic institutions, and patient groups were identified through Clinical Trials Transformation Initiative and Drug Information Association rosters and mailing lists. Objectives, practices, and perceived barriers related to engaging patient groups in the planning, conduct, and interpretation of clinical trials were reported in an online survey. Descriptive and inferential statistical analysis of survey data followed a literature review to inform survey questions.Survey respondents (n = 179 valued the importance of involving patient groups in research; however, patient group respondents valued their contributions to research protocol development, funding acquisition, and interpretation of study results more highly than those contributions were valued by industry and academic respondents (all p < .001. Patient group respondents placed higher value in open communications, clear expectations, and detailed contract execution than did non-patient group respondents (all p < .05. Industry and academic respondents more often cited internal bureaucratic processes and reluctance to share information as engagement barriers than did patient group respondents (all p < .01. Patient groups reported that a lack of transparency and understanding of the benefits of collaboration on the part of industry and academia were greater barriers than did non-patient group respondents (all p< .01.Despite reported similarities among approaches to engagement by the three stakeholder groups, key differences exist in perceived barriers and benefits to partnering with patient groups among the

Optimal use of MRI in clinical trials, clinical care and clinical registries of patients with rheumatoid arthritis

DEFF Research Database (Denmark)

Østergaard, Mikkel; Møller-Bisgaard, Signe

2014-01-01

the benefits of including MRI in treat-to-target strategies. The benefits of incorporating MRI into clinical registries are not yet known, but may include improved knowledge about the real-life advantages of MRI, as well as opportunities to develop better clinical and laboratory composite measures to monitor......Magnetic resonance imaging (MRI) clearly is more sensitive than clinical examination and conventional radiography (x-ray) for detection of inflammation (synovitis, bone marrow oedema (osteitis) and tenosynovitis) and damage (bone erosion and cartilage loss/joint space narrowing) in patients...... with rheumatoid arthritis (RA). The question is when and how MRI should be used. The present article reviews our knowledge about, and provides suggestions for, the use of MRI in clinical trials, clinical care and clinical registries. In clinical trials, the OMERACT RA MRI scoring system (RAMRIS) is a thoroughly...

Patients' Perceptions of Dehumanization of Patients in Dental School Settings: Implications for Clinic Management and Curriculum Planning.

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Raja, Sheela; Shah, Raveena; Hamad, Judy; Van Kanegan, Mona; Kupershmidt, Alexandra; Kruthoff, Mariela

2015-10-01

Although the importance of empathy, rapport, and anxiety/pain awareness in dentist-patient relations has been well documented, these factors continue to be an issue with patients in many dental school clinics. The aim of this study was to develop an in-depth understanding of how patients at an urban, university-affiliated medical center and its dental school's clinic experienced oral health care and to generate ideas for improving the dental school's clinical curriculum and management of the clinic. Although patient satisfaction surveys are common, in-depth patient narratives are an underutilized resource for improving dental education. In-depth qualitative interviews were conducted with 20 uninsured or underinsured dental patients at these sites, and the results were analyzed using content analysis. Major phenomena that participants discussed were the importance of empathy and good rapport with their oral health providers and provider awareness of dental pain and anxiety. Many patients also discussed feeling dehumanized during dental visits. Based on their positive and negative experiences, the participants made suggestions for how oral health professionals can successfully engage patients in treatment.

Role of clinical nurse leadership in improving patient care.

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Murphy, Jill; Quillinan, Bernie; Carolan, Mary

2009-12-01

Leadership in nursing plays a crucial part in the provision of good patient care. However, the terms 'nursing leadership' and 'nursing management' are often confused. This article discusses the difficulties in defining 'clinical leadership', outlines its development in the Republic of Ireland, and identifies issues that must be addressed if clinical nurse leaders are to be effective.

Orthokeratology: clinical utility and patient perspectives

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Charm J

2017-02-01

Full Text Available Jessie Charm Sight Enhancement Center, Hong Kong Special Administrative Region Abstract: Orthokeratology (ortho-k is a special rigid contact lens worn at night to achieve myopic reduction and control. This review provides an overview on prescribing ortho-k, including clinical consideration on patient aspect and lens design; its clinical outcomes; and clinical efficacy and safety. Patient satisfaction was summarized. In order to achieve long-term healthy ortho-k treatment, it requires both patient and practitioners’ care and rapport to maintain good ocular health and lens conditions. Keywords: orthokeratology, efficacy, patient satisfaction, myopic reduction, myopic control

Development of clinical practice guidelines.

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Hollon, Steven D; Areán, Patricia A; Craske, Michelle G; Crawford, Kermit A; Kivlahan, Daniel R; Magnavita, Jeffrey J; Ollendick, Thomas H; Sexton, Thomas L; Spring, Bonnie; Bufka, Lynn F; Galper, Daniel I; Kurtzman, Howard

2014-01-01

Clinical practice guidelines (CPGs) are intended to improve mental, behavioral, and physical health by promoting clinical practices that are based on the best available evidence. The American Psychological Association (APA) is committed to generating patient-focused CPGs that are scientifically sound, clinically useful, and informative for psychologists, other health professionals, training programs, policy makers, and the public. The Institute of Medicine (IOM) 2011 standards for generating CPGs represent current best practices in the field. These standards involve multidisciplinary guideline development panels charged with generating recommendations based on comprehensive systematic reviews of the evidence. The IOM standards will guide the APA as it generates CPGs that can be used to inform the general public and the practice community regarding the benefits and harms of various treatment options. CPG recommendations are advisory rather than compulsory. When used appropriately, high-quality guidelines can facilitate shared decision making and identify gaps in knowledge.

Assessment of clinical trial participant patient satisfaction: a call to action.

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Pflugeisen, Bethann Mangel; Rebar, Stacie; Reedy, Anne; Pierce, Roslyn; Amoroso, Paul J

2016-10-06

As patient satisfaction scores become increasingly relevant in today's health care market, we sought to evaluate satisfaction of the unique subset of patients enrolling in clinical trials in a research facility embedded within a community hospital system. We developed and deployed a patient satisfaction survey tailored to clinical trial patients who consented to and/or completed a clinical trial in our research institute in the prior year. The survey was distributed to 222 patients. Likert scale responses were analyzed using top box and percentile rank procedures. Correlation analysis was used to evaluate associations between the clinical trial experience and intent to return to our system for routine care. Ninety surveys were returned in the 6 months following the mailing for a 41 % response rate; the bulk of these (N = 81) were returned within 6 weeks of the mailing. The questions with the highest ranking responses were related to interactions with staff (84th percentile or higher). Fifty-one point one percent of patients (64th percentile) strongly agreed that they would seek future care in our system. Patient intent to return to the provider seen during the clinical trial was most highly correlated with intent to seek future care within our system (r = 0.54, p system-based clinical trials and the relationship between clinical trial participation and perception of the healthcare system as a desirable resource for routine medical care. We argue that this work is invaluable to the research community and submit a call to action to our peers to begin systematic evaluation of clinical trial patient satisfaction.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

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Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

The Assessment of Patient Clinical Outcome: Advantages, Models, Features of an Ideal Model

Directory of Open Access Journals (Sweden)

Mou’ath Hourani

2016-06-01

Full Text Available Background: The assessment of patient clinical outcome focuses on measuring various aspects of the health status of a patient who is under healthcare intervention. Patient clinical outcome assessment is a very significant process in the clinical field as it allows health care professionals to better understand the effectiveness of their health care programs and thus for enhancing the health care quality in general. It is thus vital that a high quality, informative review of current issues regarding the assessment of patient clinical outcome should be conducted. Aims & Objectives: 1 Summarizes the advantages of the assessment of patient clinical outcome; 2 reviews some of the existing patient clinical outcome assessment models namely: Simulation, Markov, Bayesian belief networks, Bayesian statistics and Conventional statistics, and Kaplan-Meier analysis models; and 3 demonstrates the desired features that should be fulfilled by a well-established ideal patient clinical outcome assessment model. Material & Methods: An integrative review of the literature has been performed using the Google Scholar to explore the field of patient clinical outcome assessment. Conclusion: This paper will directly support researchers, clinicians and health care professionals in their understanding of developments in the domain of the assessment of patient clinical outcome, thus enabling them to propose ideal assessment models.

Benzodiazepine use in medical out-patient clinics: a study from a developing country

International Nuclear Information System (INIS)

Patel, M.J.; Ahmer, S.; Khan, F.; Qureshi, A.W.A.; Shehzad, M.F.

2013-01-01

Objective: To estimate the prevalence of Benzodiazepine use in the outpatient setting of general medicine clinics at a single tertiary care centre. Methods: The prospective prevalence study was conducted in the outpatient setting of Internal Medicine Clinics at Aga Khan University Hospital, Karachi, from November to December 2009. All subjects were interviewed after informed consent and variables were recorded on a specially-designed proforma. Apart from basic demographics and comorbid conditions, duration, frequency and route of benzodiazepine use, as well as the reason and who initiated it was noted. Chi-square test and t test was applied to see the association of socio demographic or clinical factors with the use of benzodiazepine. Results: Of the 355 patients, 129 (36.33%) reported using the drug. The majority (n=86; 24.2%) were taking it on a daily basis. The highest numbers of patients using the drug were suffering from cardiovascular problems, 32 (25%) followed by 22 (17%) from endocrinology. Diazepam equivalent dose was around 7.04+-4, with a inter-quartile range of 3-96 weeks. Alprazolam (9%) was the most frequently prescribed Benzodiazepine. Conclusion: Benzodiazepine use is alarmingly high in the outpatient clinics of General Internal Medicine Department. There is no implementation of law to prevent its hazardous sale. In this regard all concerned should work collectively for awareness and irrational drug sale and use. (author)

Development of a renal transplant clinical pathway: one hospital's journey.

Science.gov (United States)

Darrikhuma, I M

1999-05-01

Mounting pressures to resolve multiple challenges related to quality, cost, and access in a resource-driven, customer-focused health care environment have compelled clinicians to develop innovative strategies to provide cost-effective, state-of-the-art care. Targeted patient groups include those associated with high cost, high volume, or high resource use. Patients undergoing renal transplantation fall into one or more of these categories. Recently, the management of patients with end-stage renal disease (ESRD) has come under national focus, as evidenced by the fact that Health Care Financing Administration (HCFA) has commissioned an ESRD managed care demonstration project. The purpose of this article is to describe how one case management tool--the clinical pathway--can be used to decrease costs and improve outcomes associated with renal transplantation. This discussion will include a review of the origins and components of clinical pathways and a description of how one institution developed, implemented, evaluated, and refined a renal transplantation clinical pathway.

Clinical Predictive Modeling Development and Deployment through FHIR Web Services.

Science.gov (United States)

Khalilia, Mohammed; Choi, Myung; Henderson, Amelia; Iyengar, Sneha; Braunstein, Mark; Sun, Jimeng

2015-01-01

Clinical predictive modeling involves two challenging tasks: model development and model deployment. In this paper we demonstrate a software architecture for developing and deploying clinical predictive models using web services via the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR) standard. The services enable model development using electronic health records (EHRs) stored in OMOP CDM databases and model deployment for scoring individual patients through FHIR resources. The MIMIC2 ICU dataset and a synthetic outpatient dataset were transformed into OMOP CDM databases for predictive model development. The resulting predictive models are deployed as FHIR resources, which receive requests of patient information, perform prediction against the deployed predictive model and respond with prediction scores. To assess the practicality of this approach we evaluated the response and prediction time of the FHIR modeling web services. We found the system to be reasonably fast with one second total response time per patient prediction.

Clinical findings and effect of sodium hydrogen carbonate in patients with glutathione synthetase deficiency.

Science.gov (United States)

Gündüz, Mehmet; Ünal, Özlem; Kavurt, Sumru; Türk, Emrecan; Mungan, Neslihan Önenli

2016-04-01

Glutathione synthetase (GS) deficiency is a rare inborn error of glutathione (GSH) metabolism manifested by severe metabolic acidosis, hemolytic anemia, neurological problems and massive excretion of pyroglutamic acid (5-oxoproline) in the urine. The disorder has mild, moderate, and severe clinical variants. We aimed to report clinical and laboratory findings of four patients, effect of sodium hydrogen carbonate treatment and long-term follow up of three patients. Urine organic acid analysis was performed with gas chromatography-mass spectrometry. Molecular genetic analysis was performed in three patients, mutation was found in two of them. Enzyme analysis was performed in one patient. Clinical and laboratory findings of four patients were evaluated. One patient died at 4 months old, one patient's growth and development are normal, two patients have developed intellectual disability and seizures in the long term follow up period. Three patients benefited from sodium hydrogen carbonate treatment. The clinical picture varies from patient to patient, so it is difficult to predict the prognosis and the effectiveness of treatment protocols. We reported long term follow up of four patients and demonstrated that sodium hydrogen carbonate is effective for treatment of chronic metabolic acidosis in GS deficieny.

International collaboration including patients is essential to develop new therapies for patients with myositis.

Science.gov (United States)

Lundberg, Ingrid E; Vencovsky, Jiri

2017-05-01

To discuss the needs for international collaborations between investigators in different disciplines working with myositis and with patients with myositis. Recent advances in detection of several myositis-specific autoantibodies that are associated with distinct clinical phenotypes, will enable studies in new well defined clinically homogenous subgroups of myositis This is likely to lead to development of new information on molecular pathogenesis that might be different in different myositis subgroups. Subgrouping patients according to autoantibody profile may also be important to assess outcome, to identify prognostic biomarkers and in clinical trials. As these are rare disorders international collaboration is essential to enrol large enough cohorts of the subgroups. To facilitate such collaboration we have developed a web-based international myositis register, www.euromyositis.eu, which includes validated outcome measures and patient reported outcome measures. This register is to support research but also to support decision-making in the clinic. We welcome investigators to join the Euromyositis register. Myositis is a heterogeneous disorder with varying treatment response and outcome. There is a high unmet need for new therapies which can only be achieved by increased knowledge on molecular disease mechanisms. Subgrouping patients according to autoantibody profile may be a new way forward to get a better understanding on disease mechanisms and to develop novel therapies.

[Clinical spectrum of patients with spontaneous retroperitoneal hematomas].

Science.gov (United States)

Sánchez-González, Amada; Riancho-Zarrabeitia, Leyre; Salmón-González, Zaida; Riancho, José Antonio; Valero, Carmen

2015-10-05

Spontaneous retroperitoneal hematoma (SRH) is a potentially fatal clinical entity requiring immediate recognition and intervention. The clinical records of 18-year-old and older patients admitted to the University Hospital Marqués de Valdecilla from 2003 to 2013 were reviewed. "Spontaneous" was defined as unrelated to trauma, invasive procedures or bleeding due to aortic aneurysm rupture. Thirty-four patients with SRH (44% were on anticoagulant drugs). One-third of cases had chronic renal insufficiency. Abdominal pain was the most common symptom both in anticoagulated and non-anticoagulated patients (80% in anticoagulated and 89% in non-anticoagulated patients). About one half of the patients developed shock. A CT scan was the most commonly performed diagnostic test, followed by abdominal ultrasound. Most cases were managed conservatively (80%). More than half of the patients (66%) restarted anticoagulation therapy after the acute event with a mean delay of 19 days (range 2-90 days). None of them suffered a new bleeding episode. Restarting the anticoagulation treatment after hematoma resolution seems to be a safe practice. There is an increasing frequency of SRH in non-anticoagulated patients. Copyright © 2015 Elsevier España, S.L.U. All rights reserved.

Ophthalmology patients' interest in online access to clinic notes at three US clinics.

Science.gov (United States)

Lee, Bryan S; Oster, Natalia V; Chen, Galen Y; Ding, Leona L; Walker, Janice D; Elmore, Joann G

2017-07-01

This study aimed to understand patients' perceptions about potential benefits and harms of accessing their own ophthalmology clinic notes via an electronic patient portal as part of the OpenNotes initiative. The authors conducted a cross-sectional, in-person survey of ophthalmology patients at three US eye clinics. The paper survey was self-administered or administered with assistance from study staff before or after patients' clinical visits. The authors used descriptive statistics to summarise patient characteristics and patient attitudes about accessing their ophthalmology notes online. Chi-square and t-tests were performed to assess differences in patient responses between clinic locations. Four hundred and fifty-one patients responded (response rate 65%). Most patients thought that accessing doctors' notes online was a good idea (95%), wanted to view their clinic notes online (94%), and agreed online access would increase their understanding of their eye problems (95%) and help them better remember their care plan (94%); 14% said online access would increase their worry; 43% had privacy concerns; and 96% indicated they would show or discuss their notes with at least one other person. Non-white patients were more likely than white patients to perceive online clinic notes as a useful tool, but they were also more likely to worry and to express greater privacy concerns. Patients at three US eye clinics were strongly in favour of online access to ophthalmology notes and were optimistic this access would improve their understanding and self-care. Ophthalmologists should consider offering online access to their notes to enhance doctor-patient communication and improve clinical outcomes. © 2017 The Authors Ophthalmic & Physiological Optics © 2017 The College of Optometrists.

Clinical chemistry since 1800: growth and development.

Science.gov (United States)

Rosenfeld, Louis

2002-01-01

The 19th and 20th centuries witnessed the growth and development of clinical chemistry. Many of the individuals and the significance of their contributions are not very well known, especially to new members of the profession. This survey should help familiarize them with the names and significance of the contributions of physicians and chemists such as Fourcroy, Berzelius, Liebig, Prout, Bright, and Rees. Folin and Van Slyke are better known, and it was their work near the end of the second decade of the 20th century that brought the clinical chemist out of the annex of the mortuary and into close relationship with the patient at the bedside. However, the impact on clinical chemistry and the practice of medicine by the 1910 exposé written by Abraham Flexner is not as well known as it deserves to be, nor is the impetus that World War I gave to the spread of laboratory medicine generally known. In the closing decades of the 20th century, automated devices produced an overabundance, and an overuse and misuse, of testing to the detriment of careful history taking and bedside examination of the patient. This is attributable in part to a fascination with machine-produced data. There was also an increased awareness of the value of chemical methods of diagnosis and the need to bring clinician and clinical chemist into a closer partnership. Clinical chemists were urged to develop services into dynamic descriptions of the diagnostic values of laboratory results and to identify medical relevance in interpreting significance for the clinician.

Clinical Correlates of Computationally Derived Visual Field Defect Archetypes in Patients from a Glaucoma Clinic.

Science.gov (United States)

Cai, Sophie; Elze, Tobias; Bex, Peter J; Wiggs, Janey L; Pasquale, Louis R; Shen, Lucy Q

2017-04-01

To assess the clinical validity of visual field (VF) archetypal analysis, a previously developed machine learning method for decomposing any Humphrey VF (24-2) into a weighted sum of clinically recognizable VF loss patterns. For each of 16 previously identified VF loss patterns ("archetypes," denoted AT1 through AT16), we screened 30,995 reliable VFs to select 10-20 representative patients whose VFs had the highest decomposition coefficients for each archetype. VF global indices and patient ocular and demographic features were extracted retrospectively. Based on resemblances between VF archetypes and clinically observed VF patterns, hypotheses were generated for associations between certain VF archetypes and clinical features, such as an association between AT6 (central island, representing severe VF loss) and large cup-to-disk ratio (CDR). Distributions of the selected clinical features were compared between representative eyes of certain archetypes and all other eyes using the two-tailed t-test or Fisher exact test. 243 eyes from 243 patients were included, representative of AT1 through AT16. CDR was more often ≥ 0.7 among eyes representative of AT6 (central island; p = 0.002), AT10 (inferior arcuate defect; p = 0.048), AT14 (superior paracentral defect; p = 0.016), and AT16 (inferior paracentral defect; p = 0.016) than other eyes. CDR was more often 6D (p = 0.069). Shared clinical features between computationally derived VF archetypes and clinically observed VF patterns support the clinical validity of VF archetypal analysis.

Serum levels of Th1/Th2 cytokines in aged patients and their correlation with eczema development and clinical manifestation

Directory of Open Access Journals (Sweden)

Wei-Gang Wang

2016-05-01

Full Text Available Objective: To investigate variations of Th1/Th2 cytokine levels, as well as their correlation with eczema development and clinical manifestation in aged patients. Methods: A total of 92 patients (above 60 years old with eczema diagnosed by the outpatient department of dermatology and venerology of our hospital were included as the eczema group, while 60 aged patients without eczema as the healthy group. Patients' serum levels of Th1/Th2 cytokines were examined for inter-group comparison and stratified analysis as per clinical manifestation. Results: Serum levels of interleukin (IL-2, IL-4, IL-10, IL-12, tumor necrosis factor (TNF- α and interferon (IFN- γ were all significantly higher in patients of the eczema group than the healthy group. Acute stage levels of IL-2, IL-4, IL-10 and IFN-γ were significantly higher in patients of the eczema group than the healthy group. There was no significant difference in the levels of IL-12 and TNF-α between patients of the acute stage and those of the chronic stage. And no significant difference existed in the levels of IL-2, IL-4, IL-10, IL-12, TNF-α and IFN-γ between generalized and localized eczema patients. Conclusion: Compared with the healthy population, Th1/Th2 cytokine levels are significantly different in eczema patients, especially those in the acute stage.

Development of electronic clinical path for patients with H and N cancer treated with carbon ion radiotherapy

International Nuclear Information System (INIS)

Ebisutani, Asuka; Okabe, Satsuki; Murakami, Masao; Kagawa, Kazufumi; Hishikawa, Yoshio

2005-01-01

The purpose of this study was to develop an electronic clinical path for patients with head and neck (H and N) tumor treated with carbon ion radiotherapy (RT) focusing on acute reactions of the oral mucosa and the skin. Between January and July, 2002, fifteen patients with H and N tumor had been treated with carbon ion radiotherapy including oral cavity in the RT fields. Acute reactions of the oral mucosa and the skin were analyzed together with face scales (FS) that is an indicator of quality of life obtained daily from patients during RT courses. Medical interventions including prescription for mucositis or dermatitis, nursing care, and changes of meal were also analyzed. Average period of being in hospital was 42.6±3.6 days and that of radiation was 27.0±1.9 days. Radiation mucositis appeared 5 days (10.8 GyE) after start of carbon ion RT, reached a maximum reaction at 20 days (Grade 1: 7%, Grade 2: 33%, Grade 3: 60%), and recovered less than Grade 1 at 44 days on average. Radiation dermatitis also appeared 8 days (18 GyE), reached a maximum at 33 days (Grade 1: 47%, Grade 2: 40%, Grade 3: 13%), and recovered less than Grade 1 at 51 days on average. Changes of FS showed deterioration 23 days after start of therapy. At the latter half of RT courses, mucositis, FS, and dermatitis reached a maximum in that order. Through analyses of the time-score plots, the change of FS seemed corresponding to that of dermatitis. The required medical interventions were change of meal in 10, analgesics in 8, and gargles in 15 patients. Based on these results, we established a clinical path as a trial piece. We confirmed that there was a specific pattern in ups and downs of acute reactions of the oral mucosa and the skin during a RT course. We concluded that a clinical path is useful for patients with H and N cancer treated with carbon ion RT. (author)

Prelicensure Baccalaureate Nursing Students' Perceptions of Their Development of Clinical Reasoning.

Science.gov (United States)

Herron, Elizabeth K; Sudia, Tanya; Kimble, Laura P; Davis, Alison H

2016-06-01

Establishing a strong foundation for the development of clinical reasoning in nursing students is essential to ensure safe and effective patient care. This study explored prelicensure baccalaureate nursing students' perceptions of their development of clinical reasoning, as well as their perceptions of how it is taught. In this phenomenological study, individual semistructured interviews were conducted to gather data related to participants' perceptions of their development of clinical reasoning. Data were analyzed using procedural steps delineated by Giorgi. Data analysis revealed three main themes: Instructor Characteristics, Importance of Clinical Reasoning, and Best Place to Learn Clinical Reasoning. Students recognized how clinical reasoning enhances safe and effective clinical practice and indicated the clinical arena was the most beneficial environment in which to learn clinical reasoning. Understanding students' perceptions of learning benefits nurse educators in planning nursing program curricula to enhance and facilitate the development of clinical reasoning. [J Nurs Educ. 2016;55(6):329-335.]. Copyright 2016, SLACK Incorporated.

Influences upon pediatricians’ willingness to refer patients to clinical research

Directory of Open Access Journals (Sweden)

Jeanne Dalen

2010-03-01

Full Text Available Jeanne Dalen1, Robert D Annett2, Janet L Brody1, Mandy L Perryman31Center for Family and Adolescent Research, Oregon Research Institute, Portland, OR, USA; 2University of New Mexico Health Sciences Center, Albuquerque, NM, USA; 3School of Education and Human Development, Lynchburg College, Lynchburg, UA, USAPurpose: The purpose of this brief report is to determine factors that influence the willingness of pediatricians to refer their patients to clinical research and to explore the relationship between pediatrician characteristics and self-reported number of patients referred to clinical research.Method: Forty-three pediatricians from an academic pediatrics department of a university children’s hospital in Albuquerque, New Mexico rated how influential 10 reasons would be in their decision to refer a patient to pediatric clinical research.Results: Differences among the influences for pediatrician referral to research were observed. The most influential consideration for referral was the scientific merit of the study, followed by patient benefit. Contextual factors and physician compensation were identified as the least important reasons pediatricians refer patients to research. Analyses also revealed significant relationships between referrals made and percentage of time spent in research activities.Conclusions: Pediatricians may be more likely to refer their patients to clinical research studies when they believe the purpose of the study is meaningful to patients as well as to future patient populations. In addition, characteristics of the individual pediatricians may play an important role in actual referral behavior.Keywords: recruitment, clinical research, adolescent research, pediatrician attitudes

Cardiovascular safety of liraglutide assessed in a patient-level pooled analysis of phase 2: 3 liraglutide clinical development studies.

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Marso, Steven P; Lindsey, Jason B; Stolker, Joshua M; House, John A; Martinez Ravn, Gabriela; Kennedy, Kevin F; Jensen, Troels M; Buse, John B

2011-07-01

We assessed the cardiovascular safety of liraglutide, a glucagon-like peptide-1 receptor agonist, using existing clinical data. Patient-level results from all completed phase 2 and 3 studies from the liraglutide clinical development programme were pooled to determine rates of major adverse cardiovascular events (MACE): cardiovascular death, myocardial infarction, stroke. MACE were identified by querying the study database using Medical Dictionary for Regulatory Activities (MedDRA) terms combined with serious adverse events recorded by study investigators. Broad, narrow, and custom groups of MedDRA queries were used. Candidate events from each query were independently adjudicated post hoc. In 15 studies (6638 patients; 4257 liraglutide treated), there were 114 patients with MACE identified using the broad MedDRA query. Of these, 44 were classified as serious adverse events and 39 were adjudicated as MACE. The incidence ratio for adjudicated broad/serious MACE associated with liraglutide was 0.73 (95% CI 0.38-1.41) versus all comparator drugs (metformin, glimepiride, rosiglitazone, insulin glargine, placebo), within cardiovascular safety limits defined by the United States Food & Drug Administration for diabetes therapies under current investigation.

CLINICAL FEATURES OF ACUTE FEBRILE THROMBOCYTOPAENIA AMONG PATIENTS ATTENDING PRIMARY CARE CLINICS

Directory of Open Access Journals (Sweden)

Khairani Omar

2006-01-01

Full Text Available Introduction: Identifying clinical features that differentiate acute febrile thrombocytopaenia from acute febrile illness without thrombocytopaenia can help primary care physician to decide whether to order a full blood count (FBC. This is important because thrombocytopaenia in viral fever may signify more serious underlying aetiology like dengue infection.Objective: The aim of this study was to compare the clinical features of acute febrile patients with thrombocytopaenia and acute febrile patients without thrombocytopaenia.Methodology: This was a clinic-based cross-sectional study from May to November 2003. Consecutive patients presenting with undifferentiated fever of less than two weeks were selected from the Primary Care Centre of Hospital Universiti Kebangsaan Malaysia and Batu 9 Cheras Health Clinic. Clinical features of these patients were recorded and FBC examination was done for all patients. Thrombocytopaenia was defined as platelet count <150X109/L. The odds ratio of thrombocytopaenia for each presenting symptoms was calculated.Result: Seventy-three patients participated in this study. Among them, 45.2% had thrombocytopaenia. Myalgia and headache were common among all patients. However, nausea and vomiting occurred significantly more often among patients with thrombocytopaenia than in patients with normal platelet count (OR 2.2, 95% CI 1.1-4.5.Conclusion: Acute non-specific febrile patients presenting with symptoms of nausea and vomiting may have higher risk of thrombocytopaenia and should be seriously considered for FBC.

Development of clinical application of radiation

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Kim, Mi Sook; Yoo, Seoung Yul; Yoo, Hyung Jun [and others

2000-04-01

The aim is to develop the clinical radiation therapy techniques, which increase local control and cure rate of cancer. The contents were 1. technique of stereotactic radiotherapy 2. technique of intraoperative radiation therapy(IORT) 3. technique of fractionated radiotherapy 4. technique of 3D conformal therapy 5. chemoradiotherapy in lung cancer, rectal cancer and biliopancreatic cancer 6. network based information communication system of radiation oncology 7. animal studies for the best application of chemoradiotherapy and for elucidating mechanism of slide effect in radiotherapy. The results were 1. completion of quality assurance protocol, frame and mounting system 2. completion of applicator of IORT 3. clinical protocol of fractionated radiotherapy 4. clinical protocol of 3D conformal therapy for brain, head and neck, breast and lung cancer 5. completion of multimodality treatment protocol for lung, rectal and biliopancreatic cancer 6. completion of database system for patient information and simulation image 7. standardization of estimation for radiation induced pneumonitis in animal model. Future plans are (1) developed fractionated stereotactic radiotherapy system will be commercialized (2) developed applicator of brachytherapy for IORT will be commercialized (3) 3D conformal therapy will increase local control rate for brain tumor and decrease complications such as zerostomia after treatment for nasopharygeal cancer (4) training manpower and skills for randomized clinical trial (5) suggest possibility of clinical usefulness of oral 5-fluorouracil (6) to provide basic technique for electric chart (7) promote developing database system for image information (8) also in view of double edge sword effect of NO, it is possible to modify the NO production from irradiation to increase the tolerance to radiation.

Development of clinical application of radiation

International Nuclear Information System (INIS)

Kim, Mi Sook; Yoo, Seoung Yul; Yoo, Hyung Jun

2000-04-01

The aim is to develop the clinical radiation therapy techniques, which increase local control and cure rate of cancer. The contents were 1. technique of stereotactic radiotherapy 2. technique of intraoperative radiation therapy(IORT) 3. technique of fractionated radiotherapy 4. technique of 3D conformal therapy 5. chemoradiotherapy in lung cancer, rectal cancer and biliopancreatic cancer 6. network based information communication system of radiation oncology 7. animal studies for the best application of chemoradiotherapy and for elucidating mechanism of slide effect in radiotherapy. The results were 1. completion of quality assurance protocol, frame and mounting system 2. completion of applicator of IORT 3. clinical protocol of fractionated radiotherapy 4. clinical protocol of 3D conformal therapy for brain, head and neck, breast and lung cancer 5. completion of multimodality treatment protocol for lung, rectal and biliopancreatic cancer 6. completion of database system for patient information and simulation image 7. standardization of estimation for radiation induced pneumonitis in animal model. Future plans are 1) developed fractionated stereotactic radiotherapy system will be commercialized 2) developed applicator of brachytherapy for IORT will be commercialized 3) 3D conformal therapy will increase local control rate for brain tumor and decrease complications such as zerostomia after treatment for nasopharygeal cancer 4) training manpower and skills for randomized clinical trial 5) suggest possibility of clinical usefulness of oral 5-fluorouracil 6) to provide basic technique for electric chart 7) promote developing database system for image information 8) also in view of double edge sword effect of NO, it is possible to modify the NO production from irradiation to increase the tolerance to radiation

DEVELOPING AN IPAD® APPLICATION FOR DATA COLLECTION IN A RHEUMATOLOGY RESEARCH CLINIC.

Science.gov (United States)

Kaka, Hussam; Ayearst, Renise; Tran, Maithy; Touma, Zahi; Bagovich, Maria; Vinik, Ophir; Somaily, Mansour; Haddad, Amir; Gladman, Dafna D; Chandran, Vinod

2015-01-01

Clinical research data are often collected on paper and later inputted onto an electronic database. This method is time consuming and potentially introduces errors. Therefore, to make primary data collection more efficient and less error prone we aimed to develop a touch-screen application for data collection in a psoriatic arthritis research clinic and compared it with the pre-existing paper-based system. We developed a Web application using Java and optimized it for the iPad®. It highlights missing fields for physicians in real time, and only permits submission of data collection form after corrections are made. For its evaluation, seven physicians participated, and before each patient visit they were randomly assigned paper or iPad® data entry. Number of errors, length of visit, and time between clinic visit and completion of data entry were measured. A total of 106 patients seen in the clinic who agreed to participate were randomly assigned to be evaluated by clinic physicians using the iPad® (fifty-three patients) or a paper protocol (fifty-three patients). On average, 3.34 omissions were found per paper form, of which 2.24 would have been detected on the iPad®. The iPad® increased the mean patient encounter time from 37.2 minutes to 46.5 minutes, but eliminated delay between a clinic visit and its data entry. Entering data using the iPad® application makes the patient encounter slightly longer, but reduces "missing fields." It also eliminates the delay between clinic visit and data entry thus improving the efficiency of clinical data capture in a research setting.

Clinical outcome in measles patients hospitalized with complications

International Nuclear Information System (INIS)

Rehman, A.U.; Saeed, T.

2008-01-01

Measles is a highly communicable viral illness and is common cause of childhood mortality and morbidity. Keeping in view the high prevalence of measles in the developing world, we carried out this study to look into the complicated measles cases and clinical outcome in patients admitted in children ward of Ayub Teaching Hospital. Detailed history and physical examination of all the hospitalized patients with complication of measles were recorded in a proforma. Immunization and nutritional status of each admitted patient was assessed and the clinical outcome of measles was compared with demographic profile. one hundred thirty six hospitalized patients with complications of measles were studied. There was 60.3% male and 57.3% of patients were vaccinated against measles. Malnourished patients were 71.35% and had longer hospital stay (>5 days). Pneumonia (39.7%) and diarrhoea (38.2%) were the commonest complications. Seven children died and encephalitis (57.1%) was the commonest cause of death. The most common complications of measles are pneumonia and diarrhoea with dehydration requiring admission. Malnutrition results in more complications and longer hospital stay. Mortality is significantly associated with encephalitis. (author)

Development of a pharmacy resident rotation to expand decentralized clinical pharmacy services.

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Hill, John D; Williams, Jonathan P; Barnes, Julie F; Greenlee, Katie M; Cardiology, Bcps-Aq; Leonard, Mandy C

2017-07-15

The development of a pharmacy resident rotation to expand decentralized clinical pharmacy services is described. In an effort to align with the initiatives proposed within the ASHP Practice Advancement Initiative, the department of pharmacy at Cleveland Clinic, a 1,400-bed academic, tertiary acute care medical center in Cleveland, Ohio, established a goal to provide decentralized clinical pharmacy services for 100% of patient care units within the hospital. Patient care units that previously had no decentralized pharmacy services were evaluated to identify opportunities for expansion. Metrics analyzed included number of medication orders verified per hour, number of pharmacy dosing consultations, and number of patient discharge counseling sessions. A pilot study was conducted to assess the feasibility of this service and potential resident learning opportunities. A learning experience description was drafted, and feedback was solicited regarding the development of educational components utilized throughout the rotation. Pharmacists who were providing services to similar patient populations were identified to serve as preceptors. Staff pharmacists were deployed to previously uncovered patient care units, with pharmacy residents providing decentralized services on previously covered areas. A rotating preceptor schedule was developed based on geographic proximity and clinical expertise. An initial postimplementation assessment of this resident-driven service revealed that pharmacy residents provided a comparable level of pharmacy services to that of staff pharmacists. Feedback collected from nurses, physicians, and pharmacy staff also supported residents' ability to operate sufficiently in this role to optimize patient care. A learning experience developed for pharmacy residents in a large medical center enabled the expansion of decentralized clinical services without requiring additional pharmacist full-time equivalents. Copyright © 2017 by the American Society of

Analysis of the clinical backgrounds of patients who developed respiratory acidosis under high-flow oxygen therapy during emergency transport.

Science.gov (United States)

Ogino, Hirokazu; Nishimura, Naoki; Yamano, Yasuhiko; Ishikawa, Genta; Tomishima, Yutaka; Jinta, Torahiko; Takahashi, Osamu; Chohnabayashi, Naohiko

2016-01-01

High-flow oxygen is often administered to patients during emergency transport and can sometimes cause respiratory acidosis with disturbed consciousness, thereby necessitating mechanical ventilation. Although oxygen titration in chronic obstructive pulmonary disease patients during emergency transport reduces mortality rates, the clinical risk factors for respiratory acidosis in emergency settings are not fully understood. Therefore, we analyzed the clinical backgrounds of patients who developed respiratory acidosis during pre-hospital transport. This was a retrospective study of patients who arrived at our hospital by emergency transport in 2010 who received high-flow oxygen while in transit. Respiratory acidosis was defined by the following arterial blood gas readings: pH, ≤7.35; PaCO 2 , ≥45 mmHg; and HCO 3 - , ≥24 mmol/L. The risk factors were identified using multivariable logistic regression analysis. In 765 study patients, 66 patients showed respiratory acidosis. The following risk factors for respiratory acidosis were identified: age, ≥65 years (odds ratio [OR] 1.4; 95% confidence interval [CI], 0.7-2.8); transportation time, ≥10 min (OR 2.0; 95% CI, 1.1-3.7); three digits on the Japan Coma Scale (OR 3.1; 95% CI, 1.7-5.8); percutaneous oxygen saturation, ≤90% (OR 1.6; 95% CI, 0.8-3.0); tuberculosis (OR 4.5; 95% CI, 1.4-15.1); asthma (OR 1.8; 95% CI, 0.6-5.3); pneumonia (OR 1.5; 95% CI, 0.7-3.1); and lung cancer (OR 3.9; 95% CI, 1.5-10.1). These underlying diseases as risk factors included both comorbid diseases and past medical conditions. The factors identified may contribute to the development of respiratory acidosis. Further studies on preventing respiratory acidosis will improve the quality of emergency medical care.

Development of a Clinical Forecasting Model to Predict Comorbid Depression Among Diabetes Patients and an Application in Depression Screening Policy Making.

Science.gov (United States)

Jin, Haomiao; Wu, Shinyi; Di Capua, Paul

2015-09-03

Depression is a common but often undiagnosed comorbid condition of people with diabetes. Mass screening can detect undiagnosed depression but may require significant resources and time. The objectives of this study were 1) to develop a clinical forecasting model that predicts comorbid depression among patients with diabetes and 2) to evaluate a model-based screening policy that saves resources and time by screening only patients considered as depressed by the clinical forecasting model. We trained and validated 4 machine learning models by using data from 2 safety-net clinical trials; we chose the one with the best overall predictive ability as the ultimate model. We compared model-based policy with alternative policies, including mass screening and partial screening, on the basis of depression history or diabetes severity. Logistic regression had the best overall predictive ability of the 4 models evaluated and was chosen as the ultimate forecasting model. Compared with mass screening, the model-based policy can save approximately 50% to 60% of provider resources and time but will miss identifying about 30% of patients with depression. Partial-screening policy based on depression history alone found only a low rate of depression. Two other heuristic-based partial screening policies identified depression at rates similar to those of the model-based policy but cost more in resources and time. The depression prediction model developed in this study has compelling predictive ability. By adopting the model-based depression screening policy, health care providers can use their resources and time better and increase their efficiency in managing their patients with depression.

Clinical course and prognosis in patients with Gaucher disease and parkinsonism

Science.gov (United States)

Lopez, Grisel; Kim, Jenny; Wiggs, Edythe; Cintron, Dahima; Groden, Catherine; Tayebi, Nahid; Mistry, Pramod K.; Pastores, Gregory M.; Zimran, Ari; Goker-Alpan, Ozlem

2016-01-01

Objective: The goal of this study was to characterize the parkinsonian phenotype in patients with Gaucher disease (GD) who developed parkinsonism in order to evaluate clinical course and prognosis. Methods: This is a retrospective observational study conducted at the Clinical Center of the NIH, Bethesda, MD, over a period of 10 years. The study included 19 patients with GD and parkinsonism. The severity of Gaucher and parkinsonian symptoms was determined from clinical data including physical, neurologic, pathologic, and neurocognitive evaluations, family histories, imaging studies, olfactory testing, and validated questionnaires. Results: We found an earlier age at onset of parkinsonism and evidence of mild cognitive dysfunction in our cohort. Although the clinical course in some patients was similar to that of idiopathic Parkinson disease with a favorable levodopa response, others exhibited features characteristic of dementia with Lewy bodies. When we examined the patients as a group, we did not observe a uniformly aggressive form of parkinsonism after the initial onset of symptoms, contrary to other published reports. Conclusions: Appreciable clinical variation was seen in this cohort with GD and parkinsonism. Although some patients had early onset and prominent cognitive changes, others had a later, slower course, indicating that GBA1 mutations may not be a reliable prognostic indicator in Parkinson disease in clinical settings. PMID:27123476

Development, Validation, and Implementation of a Clinic Nurse Staffing Guideline.

Science.gov (United States)

Deeken, Debra Jean; Wakefield, Douglas; Kite, Cora; Linebaugh, Jeanette; Mitchell, Blair; Parkinson, Deidre; Misra, Madhukar

2017-10-01

Ensuring that the level of nurse staffing used to care for patients is appropriate to the setting and service intensity is essential for high-quality and cost-effective care. This article describes the development, validation, and implementation of the clinic technical skills permission list developed specifically to guide nurse staffing decisions in physician clinics of an academic medical center. Results and lessons learned in using this staffing guideline are presented.

Clinical manifestations and pulmonary radiological features in patients with triphosgene poisoning

International Nuclear Information System (INIS)

Ye Caier, Chen Weijian; Wu Enfu; Yang Yunjun; Ye Min; Liu Zaiyi

2007-01-01

Objective: To examine the clinical manifestations and pulmonary radiological features in patients with triphosgene poisoning. Methods: Clinical manifestations, laboratory tests and CT scans were analyzed retrospectively in 17 patients with triphosgene poisoning. We focused on the severity, development and repair of pulmonary impairment. Results: Plain film and CT scans in five mild cases demonstrated bilateral scattered pulmonary patchy shadows. Of 12 cases with moderate to severe diseases, three showed bilateral multiple pulmonary patchy shadows and nodules with confluence of part of the lesions on plain film and CT scans; bilateral lungs were involved in nine cases with imaging findings of bilateral disseminated pulmonary round or ovary nodules with different size, ill-defined and partly-confluent patchy shadows and thickening of both interlobular septum and the wall of bronchus. Of clinical interests, imaging findings were closely correlated with clinical course and laboratory results. Conclusion: Radiological examinations with plain films and CT scans could reveal the severity, evolvement of pulmonary edema in patients with triphosgene poisoning, and these are of clinical benefit in the early management and prognostic evaluation of patients with triphosgene poisoning. (authors)

Development of clinical pharmacy in Belgian hospitals through pilot projects funded by the government.

Science.gov (United States)

Somers, A; Spinewine, A; Spriet, I; Steurbaut, S; Tulkens, P; Hecq, J D; Willems, L; Robays, H; Dhoore, M; Yaras, H; Vanden Bremt, I; Haelterman, M

2018-04-30

Objectives The goal is to develop clinical pharmacy in the Belgian hospitals to improve drug efficacy and to reduce drug-related problems. Methods From 2007 to 2014, financial support was provided by the Belgian federal government for the development of clinical pharmacy in Belgian hospitals. This project was guided by a national Advisory Working Group. Each funded hospital was obliged to describe yearly its clinical pharmacy activities. Results In 2007, 20 pharmacists were funded in 28 pilot hospitals; this number was doubled in 2009 to 40 pharmacists over 54 institutions, representing more than half of all acute Belgian hospitals. Most projects (72%) considered patient-related activities, whereas some projects (28%) had a hospital-wide approach. The projects targeted patients at admission (30%), during hospital stay (52%) or at discharge (18%). During hospital stay, actions were mainly focused on geriatric patients (20%), surgical patients (15%), and oncology patients (9%). Experiences, methods, and tools were shared during meetings and workshops. Structure, process, and outcome indicators were reported and strengths, weaknesses, opportunities, and threats were described. The yearly reports revealed that the hospital board was engaged in the project in 87% of the cases, and developed a vision on clinical pharmacy in 75% of the hospitals. In 2014, the pilot phase was replaced by structural financing for clinical pharmacy in all acute Belgian hospitals. Conclusion The pilot projects in clinical pharmacy funded by the federal government provided a unique opportunity to launch clinical pharmacy activities on a broad scale in Belgium. The results of the pilot projects showed clear implementation through case reports, time registrations, and indicators. Tools for clinical pharmacy activities were developed to overcome identified barriers. The engagement of hospital boards and the results of clinical pharmacy activities persuaded the government to start structural

Clinical research in small genomically stratified patient populations.

Science.gov (United States)

Martin-Liberal, J; Rodon, J

2017-07-01

The paradigm of early drug development in cancer is shifting from 'histology-oriented' to 'molecularly oriented' clinical trials. This change can be attributed to the vast amount of tumour biology knowledge generated by large international research initiatives such as The Cancer Genome Atlas (TCGA) and the use of next generation sequencing (NGS) techniques developed in recent years. However, targeting infrequent molecular alterations entails a series of special challenges. The optimal molecular profiling method, the lack of standardised biological thresholds, inter- and intra-tumor heterogeneity, availability of enough tumour material, correct clinical trials design, attrition rate, logistics or costs are only some of the issues that need to be taken into consideration in clinical research in small genomically stratified patient populations. This article examines the most relevant challenges inherent to clinical research in these populations. Moreover, perspectives from the Academia point of view are reviewed as well as initiatives to be taken in forthcoming years. Copyright © 2017 Elsevier Ltd. All rights reserved.

Supporting adherence and healthy lifestyles in leg ulcer patients: systematic development of the Lively Legs program for dermatology outpatient clinics.

Science.gov (United States)

Heinen, Maud M; Bartholomew, L Kay; Wensing, Michel; van de Kerkhof, Peter; van Achterberg, Theo

2006-05-01

The objective of our project was to develop a lifestyle program for leg ulcer patients at outpatient clinics for dermatology. We used the intervention-mapping (IM) framework for systematically developing theory and evidence based health promotion programs. We started with a needs-assessment. A multidisciplinary project group of health care workers and patients was involved in all five IM steps; formulating proximal program objectives, selecting methods and strategies, producing program components, planning for adoption and implementation and planning for evaluation. Several systematic literature reviews and original studies were performed to support this process. Social Cognitive Theory was selected as the main theory behind the program 'Lively Legs' and was combined with elements of Goal-Setting Theory, the precaution adoption model and motivational interviewing. The program is conducted through health counseling by dermatology nurses and was successfully pre-tested. Also, an implementation and evaluation plan were made. Intervention mapping helped us to succeed in developing a lifestyle program with clear goals and methods, operational strategies and materials and clear procedures. Coaching leg ulcer patients towards adherence with compression therapy and healthy lifestyles should be taken on without delay. Systematic development of lifestyle programs for other patient groups should be encouraged.

NMO in pediatric patients: brain involvement and clinical expression

Directory of Open Access Journals (Sweden)

Joaquín A. Peña

2011-02-01

Full Text Available OBJECTIVE: To analyze the clinical, neuroimaging characteristics and positivity of the acquaporin water channel (NMO-IgG in pediatric patients with neuromyelitis optica (NMO. This disorder could have a variable clinical expression. To address such variability, the term NMO spectrum has been suggested. METHOD: We evaluated six pediatric patients, with a median age of 11 years at the time of the study, with the diagnosis of NMO by the Wingerchuck criteria. RESULTS: All the cases exhibited bilateral optic neuritis (ON. Four patients had abnormalities on brain MRI from the onset,although only three of them developed symptoms correlated to those lesions during the course of their disorder. NMO-IgG was positive in 80%. CONCLUSION: Optic neuropathy is the most impaired feature in NMO patients. Brain MRI lesions are not compatible with multiple sclerosis and positivity of the NMO-IgG are also present in NMO pediatric patients, confirming the heterogeneity in the expression of this disorder.

Patient registries: useful tools for clinical research in myasthenia gravis.

Science.gov (United States)

Baggi, Fulvio; Mantegazza, Renato; Antozzi, Carlo; Sanders, Donald

2012-12-01

Clinical registries may facilitate research on myasthenia gravis (MG) in several ways: as a source of demographic, clinical, biological, and immunological data on large numbers of patients with this rare disease; as a source of referrals for clinical trials; and by allowing rapid identification of MG patients with specific features. Physician-derived registries have the added advantage of incorporating diagnostic and treatment data that may allow comparison of outcomes from different therapeutic approaches, which can be supplemented with patient self-reported data. We report the demographic analysis of MG patients in two large physician-derived registries, the Duke MG Patient Registry, at the Duke University Medical Center, and the INNCB MG Registry, at the Istituto Neurologico Carlo Besta, as a preliminary study to assess the consistency of the two data sets. These registries share a common structure, with an inner core of common data elements (CDE) that facilitate data analysis. The CDEs are concordant with the MG-specific CDEs developed under the National Institute of Neurological Disorders and Stroke Common Data Elements Project. © 2012 New York Academy of Sciences.

Development and Implementation of a Pharmacist-Managed Clinical Pharmacogenetics Service

Science.gov (United States)

Crews, Kristine R.; Cross, Shane J.; McCormick, John N.; Baker, Donald K.; Molinelli, Alejandro R.; Mullins, Richard; Relling, Mary V.; Hoffman, James M.

2011-01-01

Purpose The development and implementation of a pharmacist-managed Clinical Pharmacogenetics service is described. Summary Therapeutic drug monitoring (TDM) is a well-accepted role of the pharmacist. Pharmacogenetics, the study of genetic factors that influence the variability in drug response among patients, is a rapidly evolving discipline that integrates knowledge of pharmacokinetics and pharmacodynamics with modern advances in genetic testing. There is growing evidence for the clinical utility of pharmacogenetics, and pharmacists can play an essential role in the thoughtful application of pharmacogenetics to patient care. A pharmacist-managed Clinical Pharmacogenetics service was designed and implemented. The goal of the service is to provide clinical pharmacogenetic testing for gene products important to the pharmacodynamics of medications used in our patients. The service is modeled after and integrated with an already established Clinical Pharmacokinetics service. All clinical pharmacogenetic test results are first reported to one of the pharmacists, who reviews the result and provides a written consult. The consult includes an interpretation of the result and recommendations for any indicated changes to therapy. In 2009, 136 clinical pharmacogenetic tests were performed, consisting of 66 TPMT tests, 65 CYP2D6 tests, and 5 UGT1A1 tests. Our service has been met with positive clinician feedback. Conclusion Our experience demonstrates the feasibility of the design and function of a pharmacist-managed Clinical Pharmacogenetics service at an academic specialty hospital. The successful implementation of this service highlights the leadership role that pharmacists can take in moving pharmacogenetics from research to patient care, thereby potentially improving patient outcomes. PMID:21200062

Maintaining patients' dignity during clinical care: a qualitative interview study.

Science.gov (United States)

Lin, Yea-Pyng; Tsai, Yun-Fang

2011-02-01

This article is a report of a study undertaken to understand how nurses maintain patients' dignity in clinical practice. Dignity is a core concept in nursing care and maintaining patients' dignity is critical to their recovery. In Western countries, measures to maintain dignity in patients' care include maintaining privacy of the body, providing spatial privacy, giving sufficient time, treating patients as a whole person and allowing patients to have autonomy. However, this is an under-studied topic in Asian countries. For this qualitative descriptive study, data were collected in Taiwan in 2009 using in-depth interviews with a purposive sample of 30 nurses from a teaching hospital in eastern Taiwan. The audiotaped interviews were transcribed verbatim and analysed using content analysis. Nurses' measures to maintain dignity in patient care were captured in five themes: respect, protecting privacy, emotional support, treating all patients alike and maintaining body image. Participants did not mention beneficence, a crucial element achieved through the professional care of nurses that can enhance the recovery of patients. In-service education to help nurses enhance dignity in patient care should emphasize emotional support, maintaining body image and treating all patients alike. Our model for maintaining dignity in patient care could be used to develop a clinical care protocol for nurses to use in clinical practice. © 2010 Blackwell Publishing Ltd.

A Quality Model to Select Patients in Cupping Therapy Clinics: A New Tool for Ensuring Safety in Clinical Practice.

Science.gov (United States)

Aboushanab, Tamer; AlSanad, Saud

2018-06-08

Cupping therapy is a popular treatment in various countries and regions, including Saudi Arabia. Cupping therapy is regulated in Saudi Arabia by the National Center for Complementary and Alternative Medicine (NCCAM), Ministry of Health. The authors recommend that this quality model for selecting patients in cupping clinics - first version (QMSPCC-1) - be used routinely as part of clinical practice and quality management in cupping clinics. The aim of the quality model is to ensure the safety of patients and to introduce and facilitate quality and auditing processes in cupping therapy clinics. Clinical evaluation of this tool is recommended. Continued development, re-evaluation and reassessment of this tool are important. Copyright © 2018. Published by Elsevier B.V.

Patient representatives' views on patient information in clinical cancer trials

DEFF Research Database (Denmark)

Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-01-01

of future simplified and more attractive informed consent forms. CONCLUSIONS: The emotional and cognitive responses to written patient information reported by patient representatives provides a basis for revised formats in future trials and add to the body of information that support use of plain language......BACKGROUND: Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed...... consent is possible to provide. We explored patient representatives' views and perceptions on the written trial information used in clinical cancer trials. METHODS: Written patient information leaflets used in four clinical trials for colorectal cancer were used for the study. The trials included phase I...

Excellence in clinical teaching: knowledge transformation and development required.

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Irby, David M

2014-08-01

Clinical teachers in medicine face the daunting task of mastering the many domains of knowledge needed for practice and teaching. The breadth and complexity of this knowledge continue to increase, as does the difficulty of transforming the knowledge into concepts that are understandable to learners. Properly targeted faculty development has the potential to expedite the knowledge transformation process for clinical teachers. Based on my own research in clinical teaching and faculty development, as well as the work of others, I describe the unique forms of clinical teacher knowledge, the transformation of that knowledge for teaching purposes and implications for faculty development. The following forms of knowledge for clinical teaching in medicine need to be mastered and transformed: (i) knowledge of medicine and patients; (ii) knowledge of context; (iii) knowledge of pedagogy and learners, and (iv) knowledge integrated into teaching scripts. This knowledge is employed and conveyed through the parallel processes of clinical reasoning and clinical instructional reasoning. Faculty development can facilitate this knowledge transformation process by: (i) examining, deconstructing and practising new teaching scripts; (ii) focusing on foundational concepts; (iii) demonstrating knowledge-in-use, and (iv) creating a supportive organisational climate for clinical teaching. To become an excellent clinical teacher in medicine requires the transformation of multiple forms of knowledge for teaching purposes. These domains of knowledge allow clinical teachers to provide tailored instruction to learners at varying levels in the context of fast-paced and demanding clinical practice. Faculty development can facilitate this knowledge transformation process. © 2014 John Wiley & Sons Ltd.

Automated classification of eligibility criteria in clinical trials to facilitate patient-trial matching for specific patient populations.

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Zhang, Kevin; Demner-Fushman, Dina

2017-07-01

To develop automated classification methods for eligibility criteria in ClinicalTrials.gov to facilitate patient-trial matching for specific populations such as persons living with HIV or pregnant women. We annotated 891 interventional cancer trials from ClinicalTrials.gov based on their eligibility for human immunodeficiency virus (HIV)-positive patients using their eligibility criteria. These annotations were used to develop classifiers based on regular expressions and machine learning (ML). After evaluating classification of cancer trials for eligibility of HIV-positive patients, we sought to evaluate the generalizability of our approach to more general diseases and conditions. We annotated the eligibility criteria for 1570 of the most recent interventional trials from ClinicalTrials.gov for HIV-positive and pregnancy eligibility, and the classifiers were retrained and reevaluated using these data. On the cancer-HIV dataset, the baseline regex model, the bag-of-words ML classifier, and the ML classifier with named entity recognition (NER) achieved macro-averaged F2 scores of 0.77, 0.87, and 0.87, respectively; the addition of NER did not result in a significant performance improvement. On the general dataset, ML + NER achieved macro-averaged F2 scores of 0.91 and 0.85 for HIV and pregnancy, respectively. The eligibility status of specific patient populations, such as persons living with HIV and pregnant women, for clinical trials is of interest to both patients and clinicians. We show that it is feasible to develop a high-performing, automated trial classification system for eligibility status that can be integrated into consumer-facing search engines as well as patient-trial matching systems. Published by Oxford University Press on behalf of the American Medical Informatics Association 2017. This work is written by US Government employees and is in the public domain in the US.

Clinical decision making in dermatology: observation of consultations and the patients' perspectives.

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Hajjaj, F M; Salek, M S; Basra, M K A; Finlay, A Y

2010-01-01

Clinical decision making is a complex process and might be influenced by a wide range of clinical and non-clinical factors. Little is known about this process in dermatology. The aim of this study was to explore the different types of management decisions made in dermatology and to identify factors influencing those decisions from observation of consultations and interviews with the patients. 61 patient consultations were observed by a physician with experience in dermatology. The patients were interviewed immediately after each consultation. Consultations and interviews were audio recorded, transcribed and their content analysed using thematic content analysis. The most common management decisions made during the consultations included: follow-up, carrying out laboratory investigation, starting new topical treatment, renewal of systemic treatment, renewal of topical treatment, discharging patients and starting new systemic treatment. Common influences on those decisions included: clinical factors such as ineffectiveness of previous therapy, adherence to prescribing guidelines, side-effects of medications, previous experience with the treatment, deterioration or improvement in the skin condition, and chronicity of skin condition. Non-clinical factors included: patient's quality of life, patient's friends or relatives, patient's time commitment, travel or transportation difficulties, treatment-related costs, availability of consultant, and availability of treatment. The study has shown that patients are aware that management decisions in dermatology are influenced by a wide range of clinical and non-clinical factors. Education programmes should be developed to improve the quality of decision making. Copyright © 2010 S. Karger AG, Basel.

Discharge planning in a cardiology out-patient clinic: a clinical audit.

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Ingram, Shirley; Khan, Barkat

2014-01-01

The purpose of this paper is to audit the active discharge (DC) planning process in a general cardiology clinic, by pre-assessing patients' medical notes and highlighting those suitable for potential DC to the clinic physician. The cardiology clinical nurse specialist (CNS) identified patients' for nine- to 12-month return visits one week prior to attendance. The previous consultation letter was accessed and information was documented by the CNS in the medical record. The key performance indicator (KPI) used was patient DCs for each clinic visit. The process was audited at three separate times to reflect recommended action carried out. The CNS pre-assessment and presence at the clinics significantly increased total DCs during the first period compared to usual care, 11 vs 34 per cent (p audit period, DCs fell (9 per cent) with a reduction in CNS pre-assessed DCs (10 per cent). Recommendations were implemented. The process was continued by clinic administration staff, colour coding all nine- to 12-month returns, resulted in a 19 per cent DC rate in 2012. CNS pre-assessment and highlighting DC suitability increased the number of patient DCs. As the CNS presence at the clinic reduced so did the rate of DC. Specific personnel need to be responsible for monitoring and reminding staff of the process; this does not always have to be medical or nursing. Implementing positive discharging procedures is aimed at improving quality, increasing efficiency and accessibility of services for patients. This audit describes a process to promote DC planning from cardiology outpatients.

The need for patient-centred clinical research in idiopathic pulmonary fibrosis.

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Russell, Anne-Marie; Sprangers, Mirjam A G; Wibberley, Steven; Snell, Noel; Rose, Daniel M; Swigris, Jeff J

2015-09-24

Patient-centredness is an accepted term and is perceived by healthcare professionals to be morally and ethically desirable. We are motivated by the belief that this approach will improve the patient-professional experience of the decision-making process and improve health outcomes. We acknowledge that patients, either as participants or as co-investigators, have positive contributions to make to research. As the idiopathic pulmonary fibrosis (IPF) community enters a new era of clinical research activity we consider that there is greater capacity for patient involvement and partnership.Patient involvement in research can be optimised through collaborations in the research design, study conduct, and dissemination. There is increasing interest in using patient- reported outcomes (PROs), such as health-related quality of life, and symptoms measures to inform decision-making and ensure patient perspectives are taken into account. PROs are an essential component of specialist IPF services, to monitor and improve care delivery and to measure and benchmark performance. In clinical trials, PROs can additionally be used to define entry criteria, evaluate efficacy of an intervention, and evaluate adverse events. We suggest that there is a much wider scope for including patient-centred PROs in clinical research and for creative thought in developing patient co-investigator roles.Participation in research activity requires highly refined decision-making processes, particularly in a condition such as IPF, which has an often unpredictable trajectory. The IPF research landscape has changed and the design and conduct of clinical trials in IPF requires some radical rethinking. It is accepted that involving patients in the role of co-investigators will impact the research questions we ask and result in study designs that are patient-centred. IPF clinical trials have been hindered by the lack of availability of validated, disease-specific questionnaires. A conservative approach

[Motivation of patients to participate in clinical trials. An explorative survey].

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Gaul, Charly; Malcherczyk, Annett; Schmidt, Thomas; Helm, Jürgen; Haerting, Johannes

2010-02-01

Difficulties in recruiting patients for clinical trials lead to increasing costs, and prolonged implementation of evidences into medical practice. Knowledge about motivation and barriers in potential participants would be helpful to develop successful recruitment strategies. Currently, no systematic research of determining factors affecting the decision to participate in clinical studies is available from German samples. After been given details about a potential participation in a clinical or diagnostic study in nine study centers, patients were recruited for an additional structured questionnaire survey concerning motivation and barriers to participation. 62 patients were included into the survey. 95.1% did not have any experience with clinical studies before. 66.1% met the physician explaining the study and asking for informed consent for the first time. Despite this, 96.6% judged the physician to be competent. Family and friends were important for decision-making about the participation in a study. Gender was only of marginal influence. The majority of patients (91.4%) expected advantages of the study for their own. 88% of the patients denominated potential advantages for other patients as an additional motivator. The possibility of adverse events was inferior for patients in decision-making about participation in a clinical trial. Physicians recruiting patients for clinical studies should be well prepared about details of the study and should have adequate time for an introductory conversation in a quiet environment. Including relatives into the introductory conversation may enhance the motivation and therefore the success of recruitment. Potential advantages of a participation for the own treatment and additionally for other patients should be highlighted. Possible side effects should be explained in a realistic manner.

Training clinicians in how to use patient-reported outcome measures in routine clinical practice.

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Santana, Maria J; Haverman, Lotte; Absolom, Kate; Takeuchi, Elena; Feeny, David; Grootenhuis, Martha; Velikova, Galina

2015-07-01

Patient-reported outcome measures (PROs) were originally developed for comparing groups of people in clinical trials and population studies, and the results were used to support treatment recommendations or inform health policy, but there was not direct benefit for the participants providing PROs data. However, as the experience in using those measures increased, it became obvious the clinical value in using individual patient PROs profiles in daily practice to identify/monitor symptoms, evaluate treatment outcomes and support shared decision-making. A key issue limiting successful implementation is clinicians' lack of knowledge on how to effectively utilize PROs data in their clinical encounters. Using a change management theoretical framework, this paper describes the development and implementation of three programs for training clinicians to effectively use PRO data in routine practice. The training programs are in three diverse clinical areas (adult oncology, lung transplant and paediatrics), in three countries with different healthcare systems, thus providing a rare opportunity to pull out common approaches whilst recognizing specific settings. For each program, we describe the clinical and organizational setting, the program planning and development, the content of the training session with supporting material, subsequent monitoring of PROs use and evidence of adoption. The common successful components and practical steps are identified, leading to discussion and future recommendations. The results of the three training programs are described as the implementation. In the oncology program, PRO data have been developed and are currently evaluated; in the lung transplant program, PRO data are used in daily practice and the integration with electronic patient records is under development; and in the paediatric program, PRO data are fully implemented with around 7,600 consultations since the start of the implementation. Adult learning programs teaching clinicians

Beyond cultural competency: Bourdieu, patients and clinical encounters.

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Lo, Ming-Cheng M; Stacey, Clare L

2008-07-01

In response to widely documented racial and ethnic disparities in health, clinicians and public health advocates have taken great strides to implement 'culturally competent' care. While laudable, this important policy and intellectual endeavour has suffered from a lack of conceptual clarity and rigour. This paper develops a more careful conceptual model for understanding the role of culture in the clinical encounter, paying particular attention to the relationship between culture, contexts and social structures. Linking Bourdieu's (1977) notion of 'habitus' and William Sewell's (1992) axioms of multiple and intersecting structures, we theorise patient culture in terms of 'hybrid habitus'. This conceptualisation of patient culture highlights three analytical dimensions: the multiplicity of schemas and resources available to patients, their specific patterns of integration and application in specific contexts, and the constitutive role of clinical encounters. The paper concludes with a discussion of directions for future research as well as reforms of cultural competency training courses.

Attitudes toward Placebo-Controlled Clinical Trials of Patients with Schizophrenia in Japan.

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Norio Sugawara

Full Text Available Although the use of placebo in clinical trials of schizophrenia patients is controversial because of medical and ethical concerns, placebo-controlled clinical trials are commonly used in the licensing of new drugs.The objective of this study was to assess the attitudes toward placebo-controlled clinical trials among patients with schizophrenia in Japan.Using a cross-sectional design, we recruited patients (n = 251 aged 47.7±13.2 (mean±SD with a DSM-IV diagnosis of schizophrenia or schizoaffective disorder who were admitted to six psychiatric hospitals from December 2013 to March 2014. We employed a 14-item questionnaire specifically developed to survey patients' attitudes toward placebo-controlled clinical trials.The results indicated that 33% of the patients would be willing to participate in a placebo-controlled clinical trial. Expectations for improvement of disease, a guarantee of hospital treatment continuation, and encouragement by family or friends were associated with the willingness to participate in such trials, whereas a belief of additional time required for medical examinations was associated with non-participation.Fewer than half of the respondents stated that they would be willing to participate in placebo-controlled clinical trials. Therefore, interpreting the results from placebo-controlled clinical trials could be negatively affected by selection bias.

Patient representatives? views on patient information in clinical cancer trials

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Dellson, Pia; Nilbert, Mef; Carlsson, Christina

2016-01-01

Background Patient enrolment into clinical trials is based on oral information and informed consent, which includes an information sheet and a consent certificate. The written information should be complete, but at the same time risks being so complex that it may be questioned if a fully informed consent is possible to provide. We explored patient representatives? views and perceptions on the written trial information used in clinical cancer trials. Methods Written patient information leaflet...

Time dependent patient no-show predictive modelling development.

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Huang, Yu-Li; Hanauer, David A

2016-05-09

Purpose - The purpose of this paper is to develop evident-based predictive no-show models considering patients' each past appointment status, a time-dependent component, as an independent predictor to improve predictability. Design/methodology/approach - A ten-year retrospective data set was extracted from a pediatric clinic. It consisted of 7,291 distinct patients who had at least two visits along with their appointment characteristics, patient demographics, and insurance information. Logistic regression was adopted to develop no-show models using two-thirds of the data for training and the remaining data for validation. The no-show threshold was then determined based on minimizing the misclassification of show/no-show assignments. There were a total of 26 predictive model developed based on the number of available past appointments. Simulation was employed to test the effective of each model on costs of patient wait time, physician idle time, and overtime. Findings - The results demonstrated the misclassification rate and the area under the curve of the receiver operating characteristic gradually improved as more appointment history was included until around the 20th predictive model. The overbooking method with no-show predictive models suggested incorporating up to the 16th model and outperformed other overbooking methods by as much as 9.4 per cent in the cost per patient while allowing two additional patients in a clinic day. Research limitations/implications - The challenge now is to actually implement the no-show predictive model systematically to further demonstrate its robustness and simplicity in various scheduling systems. Originality/value - This paper provides examples of how to build the no-show predictive models with time-dependent components to improve the overbooking policy. Accurately identifying scheduled patients' show/no-show status allows clinics to proactively schedule patients to reduce the negative impact of patient no-shows.

Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level

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de Vos Barbara

2010-11-01

Full Text Available Abstract Background There is a growing interest to use health status or disease control questionnaires in routine clinical practice. However, the validity of most questionnaires is established using techniques developed for group level validation. This study examines a new method, using patient interviews, to validate a short health status questionnaire, the Clinical COPD Questionnaire (CCQ, at the individual patient level. Methods Patients with COPD who visited an outpatient clinic completed the CCQ before the consultation, and the specialist physician completed it after the consultation. After the consultation all patients had a semi-structured in-depth interview. The patients' CCQ scores were compared with those of the treating clinician, and with mean scores from 5 clinicians from a pool of 20 who scored the CCQ after reading the transcript of the in-depth interviews only. Agreement was assessed using Lin's concordance correlation coefficient (CCC, and Blant and Altman plots. Interviews with patients with low agreement were reviewed for possible explanations. Results A total of 44 COPD patients (32 male, mean age 66 years, FEV1 45% of predicted participated. Agreement between the patients' CCQ scores and those of the treating clinicians (CCC = 0.87 and the mean score of the reviewing clinicians (CCC = 0.86 was very high. No systematic error was detected. No explanation for individuals with low agreement was found. Conclusion The validity of the CCQ on the individual patient level, as assessed by these methods, is good. Individual health status assessment with the CCQ is therefore sufficiently accurate to be used in routine clinical practice.

Clinical and Neurobiological Perspectives of Empowering Pediatric Cancer Patients Using Videogames

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Govender, Meveshni; Bowen, Randy C.; German, Massiell L.; Bulaj, Grzegorz

2015-01-01

Abstract Pediatric oncology patients often experience fatigue and physical and mental deconditioning during and following chemotherapy treatments, contributing to diminished quality of life. Patient empowerment is a core principle of patient-centered care and reflects one's ability to positively affect his or her own health behavior and health status. Empowerment interventions may enhance patients' internal locus of control, resilience, coping skills, and self-management of symptoms related to disease and therapy. Clinical and technological advancements in therapeutic videogames and mobile medical applications (mobile health) can facilitate delivery of the empowerment interventions for medical purposes. This review summarizes clinical strategies for empowering pediatric cancer patients, as well as their relationship with developing a “fighting spirit” in physical and mental health. To better understand physiological aspects of empowerment and to elucidate videogame-based intervention strategies, brain neuronal circuits and neurotransmitters during stress, fear, and resilience are also discussed. Neuroimaging studies point to the role of the reward system pathways in resilience and empowerment in patients. Taken together, videogames and mobile health applications open translational research opportunities to develop and deliver empowerment interventions to pediatric cancer patients and also to those with other chronic diseases. PMID:26287927

Clinical and Neurobiological Perspectives of Empowering Pediatric Cancer Patients Using Videogames.

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Govender, Meveshni; Bowen, Randy C; German, Massiell L; Bulaj, Grzegorz; Bruggers, Carol S

2015-10-01

Pediatric oncology patients often experience fatigue and physical and mental deconditioning during and following chemotherapy treatments, contributing to diminished quality of life. Patient empowerment is a core principle of patient-centered care and reflects one's ability to positively affect his or her own health behavior and health status. Empowerment interventions may enhance patients' internal locus of control, resilience, coping skills, and self-management of symptoms related to disease and therapy. Clinical and technological advancements in therapeutic videogames and mobile medical applications (mobile health) can facilitate delivery of the empowerment interventions for medical purposes. This review summarizes clinical strategies for empowering pediatric cancer patients, as well as their relationship with developing a "fighting spirit" in physical and mental health. To better understand physiological aspects of empowerment and to elucidate videogame-based intervention strategies, brain neuronal circuits and neurotransmitters during stress, fear, and resilience are also discussed. Neuroimaging studies point to the role of the reward system pathways in resilience and empowerment in patients. Taken together, videogames and mobile health applications open translational research opportunities to develop and deliver empowerment interventions to pediatric cancer patients and also to those with other chronic diseases.

Clinical course and signs in patients with uveitis associated with ankylosing spondylitis

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Refik Oltulu

2013-09-01

Full Text Available Aim: To evaluate clinical course and signs in patients withuveitis associated ankylosing spondylitis (AS.Methods: In this retrospective study we evaluated thepatients who were diagnosed as uveitis related to AS andfollowed up at the Ophthalmology Department of NecmettinErbakan University Hospital between May 2009 andJune 2012. Demographical features and clinical courseswere assessed.Results: Seventeen eyes of 13 patients were includedin the study. Nine patients (69.2% were male and four(30.8% were female. The mean age at presentation was38.54±9.61 years (range 28-63. Bilateral involvementwas observed in four (30.8% patients. The mean followuptime was 17.46±11.86 months (range 3-36. The meannumber of attacks was 1.15±0.37 (range 1-2. Posteriorsegment manifestation accompanied anterior uveitis inthree eyes (17.6%. Posterior synechia developed in one(7.7% and cataract in one patient (7.7%, cystoid macularedema in two patients (15.4%, and epiretinal membranein one patient (%7.7. The mean final visual acuitywas 0.975±0.07 (range 0.2-1.0.Conclusion: The prognosis of anterior uveitis associatedwith AS is good if the treatment is administered at theappropriate time. However, the posterior segment complicationsmay develop in these patients, treatment andfollow-up should be done in co-operation with the departmentof rheumatology.Key words: Ankylosing spondylitis, uveitis, rheumatology,clinical course

Accounting for the sedative and analgesic effects of medication changes during patient participation in clinical research studies: measurement development and application to a sample of institutionalized geriatric patients.

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Sloane, Philip; Ivey, Jena; Roth, Mary; Roederer, Mary; Williams, Christianna S

2008-03-01

To date, no system has been published that allows investigators to adjust for the overall sedative and/or analgesic effects of medications, or changes in medications, in clinical trial participants for whom medication use cannot be controlled. This is common in clinical trials of behavioral and complementary/alternative therapies, and in research involving elderly or chronically ill patients for whom ongoing medical care continues during the trial. This paper describes the development, and illustrates the use, of a method we developed to address this issue, in which we generate single continuous variables to represent the daily sedative and analgesic loads of multiple medications. Medications for 90 study participants in a clinical trial of a nonpharmacological intervention were abstracted from medication administration records across multiple treatment periods. An expert panel of three academic clinical pharmacists and a geriatrician met to develop a system by which each study medication could be assigned a sedative and analgesic effect rating. The two measures, when applied to data on 90 institutionalized persons with Alzheimer's disease, resulted in variables with moderately skewed distributions that are consistent with the clinical profile of analgesia and sedation use in long-term care populations. The average study participant received 1.89 analgesic medications per day and had a daily analgesic load of 2.96; the corresponding figures for sedation were 2.07 daily medications and an average daily load of 11.41. A system of classifying the sedative and analgesic effects of non-study medications was created that divides drugs into categories based on the strength of their effects and assigns a rating to express overall sedative and analgesic effects. These variables may be useful in comparing patients and populations, and to control for drug effects in future studies.

A multidisciplinary prostate cancer clinic for newly diagnosed patients: developing the role of the advanced practice nurse.

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Madsen, Lydia T; Craig, Catherine; Kuban, Deborah

2009-06-01

Newly diagnosed patients with prostate cancer have various treatment options, and a multidisciplinary prostate cancer clinic (MPCC) can present all options in a single setting. An MPCC was started in 2004 at the University of Texas M.D. Anderson Cancer Center, and 258 patients with prostate cancer were evaluated in its first year. The clinic expanded in 2006 and an oncology advanced practice nurse (APN) was recruited to address specific objectives. The APN role was used to implement a quality-of-life protocol, provide detailed patient education (including a treatment summary and care plan), and serve as a single point of contact as patients move toward a treatment decision. Formal evaluation of the MPCC showed that patients were satisfied with this approach to the complex decision-making process in prostate cancer.

Clinical evaluation in periodontitis patient after curettage

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Widowati Witjaksono

2006-09-01

Full Text Available Curettage is used in periodontics to scrap off the gingival wall of a periodontal pocket, and is needed to reduce loss of attachment (LOA by developing new connective tissue attachment in patients with periodontitis. The purpose of this study was to evaluate the success of curettage by the formation of tissue attachment. This clinical experiment was done by comparing LOA before curettage, 2 weeks and 3 weeks after curettage on 30 teeth with the indication of curettage. Study population were periodontitis patient who attending dental clinic at Hospital University Science Malaysia (HUSM with inclusion criteria good general health condition, 18 to 55 years old male or female and presented with pocket depth > 3mm. The teeth were thoroughly scaling before intervention and evaluated by measuring the periodontal attachment before curettage, two weeks and three weeks after curettage. Repeated measure ANOVA and Paired T Test were used to analyze the data. The result of the study showed that there was reduction in the periodontal attachment loss in periodontitis patient after curettage either in the anterior or posterior teeth which were supported by statistical analysis. This study concluded that curettage could make reattachment of the tissue

Patient safety and quality of care: How may clinical simulation contribute?

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Sanne Jensen

2015-09-01

Full Text Available The usability of health information technology (IT is increasingly recognized as critically important to the development of systems that ensure patient safety and quality of care. The substantial complexity of organizations, work practice and physical environments within the healthcare sector influences the development and application of health IT. When health IT is introduced in local clinical work practices, potential patient safety hazards and insufficient support of work practices need to be examined. Qualitative methods, such as clinical simulation, may be used to evaluate new technology in correlation with the clinical context and to study the interaction between users, technology and work practice. Compared with the “classic” methods, such as heuristic inspection and usability testing, clinical simulation takes the clinical context into account. Clinical simulation can be useful in many processes in the human-centred design cycle. In the requirement specification, clinical simulation can be useful to analyze user requirements and work practice as well to evaluate requirements. In the design of health IT, clinical simulation can be used to evaluate clinical information systems and serve as common ground to help to achieve a shared understanding between various communities of practice. In a public procurement process, a clinical simulation-based assessment can help give insight into different solutions and how they support work practice. Before organizational implementation, clinical simulation is a very suitable means, by which to assess an application in connection with work practice.

Biomarkers in the clinical development of asthma therapies.

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Staton, Tracy L; Choy, David F; Arron, Joseph R

2016-01-01

Here we review how biomarkers have been used in the design, execution and interpretation of recent clinical studies of therapeutic candidates targeting cytokine-mediated inflammatory pathways in asthma. This review focuses on type 2 inflammation, as there are multiple therapeutics and/or clinical studies that can be compared within that specific pathway. Comparative analyses of data from these clinical studies illustrate the utility of biomarkers to quantify pharmacodynamic effects, clarify mechanism of action and stratify patients, which may facilitate the interpretation of outcomes in the development of molecularly targeted therapies. These case examples provide a basis for biomarker considerations in the design of future studies in the asthma setting.

Patients' Values in Clinical Decision-Making.

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Faggion, Clovis Mariano; Pachur, Thorsten; Giannakopoulos, Nikolaos Nikitas

2017-09-01

Shared decision-making involves the participation of patient and dental practitioner. Well-informed decision-making requires that both parties understand important concepts that may influence the decision. This fourth article in a series of 4 aims to discuss the importance of patients' values when a clinical decision is made. We report on how to incorporate important concepts for well-informed, shared decision-making. Here, we present patient values as an important issue, in addition to previously established topics such as the risk of bias of a study, cost-effectiveness of treatment approaches, and a comparison of therapeutic benefit with potential side effects. We provide 2 clinical examples and suggestions for a decision tree, based on the available evidence. The information reported in this article may improve the relationship between patient and dental practitioner, resulting in more well-informed clinical decisions. Copyright © 2017 Elsevier Inc. All rights reserved.

Analysis of the clinical backgrounds of patients who developed respiratory acidosis under high‐flow oxygen therapy during emergency transport

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Ogino, Hirokazu; Yamano, Yasuhiko; Ishikawa, Genta; Tomishima, Yutaka; Jinta, Torahiko; Takahashi, Osamu; Chohnabayashi, Naohiko

2015-01-01

Aim High‐flow oxygen is often administered to patients during emergency transport and can sometimes cause respiratory acidosis with disturbed consciousness, thereby necessitating mechanical ventilation. Although oxygen titration in chronic obstructive pulmonary disease patients during emergency transport reduces mortality rates, the clinical risk factors for respiratory acidosis in emergency settings are not fully understood. Therefore, we analyzed the clinical backgrounds of patients who developed respiratory acidosis during pre‐hospital transport. Methods This was a retrospective study of patients who arrived at our hospital by emergency transport in 2010 who received high‐flow oxygen while in transit. Respiratory acidosis was defined by the following arterial blood gas readings: pH, ≤7.35; PaCO 2, ≥45 mmHg; and HCO 3 −, ≥24 mmol/L. The risk factors were identified using multivariable logistic regression analysis. Results In 765 study patients, 66 patients showed respiratory acidosis. The following risk factors for respiratory acidosis were identified: age, ≥65 years (odds ratio [OR] 1.4; 95% confidence interval [CI], 0.7–2.8); transportation time, ≥10 min (OR 2.0; 95% CI, 1.1–3.7); three digits on the Japan Coma Scale (OR 3.1; 95% CI, 1.7–5.8); percutaneous oxygen saturation, ≤90% (OR 1.6; 95% CI, 0.8–3.0); tuberculosis (OR 4.5; 95% CI, 1.4–15.1); asthma (OR 1.8; 95% CI, 0.6–5.3); pneumonia (OR 1.5; 95% CI, 0.7–3.1); and lung cancer (OR 3.9; 95% CI, 1.5–10.1). These underlying diseases as risk factors included both comorbid diseases and past medical conditions. Conclusions The factors identified may contribute to the development of respiratory acidosis. Further studies on preventing respiratory acidosis will improve the quality of emergency medical care. PMID:29123744

Fibrin related antigens: assay development, clinical and kinetic studies

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Kruskal, J B

1987-08-01

This thesis describes an assay which is able to measure and to determine the proportions of fibrin- and fibrinogen-related antigens (FRA) present in clinical samples. No assay exists at present which is capable of distinguishing between fibrin and fibrinogen degradation products concurrently and in a clinical setting. The assay may be used as a tool with which to gain further insight to pathophysiology of disorders characterized by activation of the coagulation and fibrinolytic pathways. This study provides and analysis of the FRA profiles in patients with disorders characterised by possible enhanced fibrinolytic activity. Studies have been undertaken on patients with acute and chronic liver diseases, on patients with the various syndromes of coronary artery disease and on patients with insulin-dependent diabetes mellitus with and without evidence of microvascular disease. Certain observations made it evident that further studies were required in order to explain previously undocumented fibrinolytic abnormalities in certain patient groups. Data obtained from patients with liver disease provided information compatible with the activation of their fibrinolytic pathways. The initial scope of this study was then extended to further investigate the deranged haemostatic mechanisms in patients with severe liver diseases. Kinetic studies were performed which required the development of specific technology to be able to measure certain previously undertermined parameters. Mathematical models describing the rates of fibrin formation and lysis were developed for human studies. Fibrin-derived D-dimer was radiolabelled and its validity as and intravenous tracer and maker of fibrin degradation established.

Development and validation of multivariable predictive model for thromboembolic events in lymphoma patients.

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Antic, Darko; Milic, Natasa; Nikolovski, Srdjan; Todorovic, Milena; Bila, Jelena; Djurdjevic, Predrag; Andjelic, Bosko; Djurasinovic, Vladislava; Sretenovic, Aleksandra; Vukovic, Vojin; Jelicic, Jelena; Hayman, Suzanne; Mihaljevic, Biljana

2016-10-01

Lymphoma patients are at increased risk of thromboembolic events but thromboprophylaxis in these patients is largely underused. We sought to develop and validate a simple model, based on individual clinical and laboratory patient characteristics that would designate lymphoma patients at risk for thromboembolic event. The study population included 1,820 lymphoma patients who were treated in the Lymphoma Departments at the Clinics of Hematology, Clinical Center of Serbia and Clinical Center Kragujevac. The model was developed using data from a derivation cohort (n = 1,236), and further assessed in the validation cohort (n = 584). Sixty-five patients (5.3%) in the derivation cohort and 34 (5.8%) patients in the validation cohort developed thromboembolic events. The variables independently associated with risk for thromboembolism were: previous venous and/or arterial events, mediastinal involvement, BMI>30 kg/m(2) , reduced mobility, extranodal localization, development of neutropenia and hemoglobin level 3). For patients classified at risk (intermediate and high-risk scores), the model produced negative predictive value of 98.5%, positive predictive value of 25.1%, sensitivity of 75.4%, and specificity of 87.5%. A high-risk score had positive predictive value of 65.2%. The diagnostic performance measures retained similar values in the validation cohort. Developed prognostic Thrombosis Lymphoma - ThroLy score is more specific for lymphoma patients than any other available score targeting thrombosis in cancer patients. Am. J. Hematol. 91:1014-1019, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Considerations in the development of circulating tumor cell technology for clinical use

Directory of Open Access Journals (Sweden)

Parkinson David R

2012-07-01

Full Text Available Abstract This manuscript summarizes current thinking on the value and promise of evolving circulating tumor cell (CTC technologies for cancer patient diagnosis, prognosis, and response to therapy, as well as accelerating oncologic drug development. Moving forward requires the application of the classic steps in biomarker development–analytical and clinical validation and clinical qualification for specific contexts of use. To that end, this review describes methods for interactive comparisons of proprietary new technologies, clinical trial designs, a clinical validation qualification strategy, and an approach for effectively carrying out this work through a public-private partnership that includes test developers, drug developers, clinical trialists, the US Food & Drug Administration (FDA and the US National Cancer Institute (NCI.

A Systematic Approach to Find a Professional Audiology Clinic: Patient-Based Information

Science.gov (United States)

Kim, Gungu; Kim, Gibbeum; Na, Wondo

2016-01-01

This brief communication introduced a systematic way to find a professional audiology clinic developed for patients and professionals by the American Academy of Audiology, American Speech-Language-Hearing Association, and Healthy Hearing. Patients can access each organization's website to find professionals and/or clinics based on criteria such as location, hours, special areas, types of service, reviews and rating by previous patients, and kinds of insurance accepted. Such a system may protect the patients from information overload, guarantee accurate information, and help them find themselves professional audiologists who can assist them. We expect professional organizations to adopt this system as soon as possible and link hearing-impaired patients with professional audiologists in Korea. PMID:27626086

Diagnostic value of patient characteristics, history, and six clinical tests for traumatic anterior shoulder instability

NARCIS (Netherlands)

van Kampen, D.A.; van den Berg, T.; van der Woude, H.J.; Castelein, R.M.; Terwee, C.B.; Willems, W.J.

2013-01-01

Background: It is unknown which combination of patient information and clinical tests might beoptimal for the diagnosis of traumatic anterior shoulder instability. This study aimed to determinethe diagnostic value of individual clinical tests and to develop a prediction model that combined patient

Developing virtual patients for medical microbiology education.

Science.gov (United States)

McCarthy, David; O'Gorman, Ciaran; Gormley, Gerry J

2013-12-01

The landscape of medical education is changing as students embrace the accessibility and interactivity of e-learning. Virtual patients are e-learning resources that may be used to advance microbiology education. Although the development of virtual patients has been widely considered, here we aim to provide a coherent approach for clinical educators. Copyright © 2013 Elsevier Ltd. All rights reserved.

Current status and future prospects of the development of clinical Pharmacy in China: A SWOT analysis.

Science.gov (United States)

Rao, Yuefeng; Zhao, Qingwei; Zhang, Xiangyi; Yang, Hongyu; Lou, Yan; Zhang, Xingguo

2016-03-01

In many industrialized countries, clinical pharmacy has developed into a separate discipline and become a vital part of inpatient care in hospitals. However, as compared to many established branches of medicine, clinical pharmacy is still in its infancy, with much room for growth, improvement, and recognition by both the medical community and patients. In this study, a widely-recognized development strategy analysis tool, Strength, Weakness, Opportunity and Threat (SWOT), was used to systematically address several key issues to the development of clinical pharmacy in China. This analysis aims to provide feasible recommendations for the development of clinical pharmacy in China by identifying current problems and growth opportunities. Full development of clinical pharmacy as a mature clinical discipline will help promote the rational use of drugs by both clinicians and patients and lead to enhanced drug efficacy and safety.

Spanish-speaking patients' satisfaction with clinical pharmacists' communication skills and demonstration of cultural sensitivity.

Science.gov (United States)

Kim-Romo, Dawn N; Barner, Jamie C; Brown, Carolyn M; Rivera, José O; Garza, Aida A; Klein-Bradham, Kristina; Jokerst, Jason R; Janiga, Xan; Brown, Bob

2014-01-01

OBJECTIVE To assess Spanish-speaking patients' satisfaction with their clinical pharmacists' communication skills and demonstration of cultural sensitivity, while controlling for patients' sociodemographic, clinical, and communication factors, as well as pharmacist factors, and to identify clinical pharmacists' cultural factors that are important to Spanish-speaking patients. DESIGN Cross-sectional study. SETTING Central Texas during August 2011 to May 2012. PARTICIPANTS Spanish-speaking patients of federally qualified health centers (FQHCs). MAIN OUTCOME MEASURE(S) A Spanish-translated survey assessed Spanish-speaking patients' satisfaction with their clinical pharmacists' communication skills and demonstration of cultural sensitivity. RESULTS Spanish-speaking patients (N = 101) reported overall satisfaction with their clinical pharmacists' communication skills and cultural sensitivity. Patients also indicated that pharmacists' cultural rapport (e.g., ability to speak Spanish, respectfulness) was generally important to Spanish speakers. Multiple linear regression analyses showed that cultural rapport was significantly related to satisfaction with pharmacists' communication skills and demonstration of cultural sensitivity. CONCLUSION Overall, patients were satisfied with pharmacists' communication skills and cultural sensitivity. Patient satisfaction initiatives that include cultural rapport should be developed for pharmacists who provide care to Spanish-speaking patients with limited English proficiency.

The process of developing audiovisual patient information: challenges and opportunities.

Science.gov (United States)

Hutchison, Catherine; McCreaddie, May

2007-11-01

The aim of this project was to produce audiovisual patient information, which was user friendly and fit for purpose. The purpose of the audiovisual patient information is to inform patients about randomized controlled trials, as a supplement to their trial-specific written information sheet. Audiovisual patient information is known to be an effective way of informing patients about treatment. User involvement is also recognized as being important in the development of service provision. The aim of this paper is (i) to describe and discuss the process of developing the audiovisual patient information and (ii) to highlight the challenges and opportunities, thereby identifying implications for practice. A future study will test the effectiveness of the audiovisual patient information in the cancer clinical trial setting. An advisory group was set up to oversee the project and provide guidance in relation to information content, level and delivery. An expert panel of two patients provided additional guidance and a dedicated operational team dealt with the logistics of the project including: ethics; finance; scriptwriting; filming; editing and intellectual property rights. Challenges included the limitations of filming in a busy clinical environment, restricted technical and financial resources, ethical needs and issues around copyright. There were, however, substantial opportunities that included utilizing creative skills, meaningfully involving patients, teamworking and mutual appreciation of clinical, multidisciplinary and technical expertise. Developing audiovisual patient information is an important area for nurses to be involved with. However, this must be performed within the context of the multiprofessional team. Teamworking, including patient involvement, is crucial as a wide variety of expertise is required. Many aspects of the process are transferable and will provide information and guidance for nurses, regardless of specialty, considering developing this

Patient centered integrated clinical resource management.

Science.gov (United States)

Hofdijk, Jacob

2011-01-01

The impact of funding systems on the IT systems of providers has been enormous and have prevented the implementation of designs to focused on the health issue of patients. The paradigm shift the Dutch Ministry of Health has taken in funding health care has a remarkable impact on the orientation of IT systems design. Since 2007 the next step is taken: the application of the funding concept on chronic diseases using clinical standards as the norm. The focus on prevention involves the patient as an active partner in the care plan. The impact of the new dimension in funding has initiated a process directed to the development of systems to support collaborative working and an active involvement of the patient and its informal carers. This national approach will be presented to assess its international potential, as all countries face the long term care crisis lacking resources to meet the health needs of the population.

A patient safety objective structured clinical examination.

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Singh, Ranjit; Singh, Ashok; Fish, Reva; McLean, Don; Anderson, Diana R; Singh, Gurdev

2009-06-01

There are international calls for improving education for health care workers around certain core competencies, of which patient safety and quality are integral and transcendent parts. Although relevant teaching programs have been developed, little is known about how best to assess their effectiveness. The objective of this work was to develop and implement an objective structured clinical examination (OSCE) to evaluate the impact of a patient safety curriculum. The curriculum was implemented in a family medicine residency program with 47 trainees. Two years after commencing the curriculum, a patient safety OSCE was developed and administered at this program and, for comparison purposes, to incoming residents at the same program and to residents at a neighboring residency program. All 47 residents exposed to the training, all 16 incoming residents, and 10 of 12 residents at the neighboring program participated in the OSCE. In a standardized patient case, error detection and error disclosure skills were better among trained residents. In a chart-based case, trained residents showed better performance in identifying deficiencies in care and described more appropriate means of addressing them. Third year residents exposed to a "Systems Approach" course performed better at system analysis and identifying system-based solutions after the course than before. Results suggest increased systems thinking and inculcation of a culture of safety among residents exposed to a patient safety curriculum. The main weaknesses of the study are its small size and suboptimal design. Much further investigation is needed into the effectiveness of patient safety curricula.

Clinical management of patients with hyperthyroidism

International Nuclear Information System (INIS)

Cooper, D.S.; Ridgway, E.C.

1985-01-01

The clinical management of the hyperthyroid patient is controversial, because there is no perfect treatment. Factors that influence the choice of therapy include the patient's age, sex, and type of hyperthyroidism, as well as patient and physician preference

Wernicke encephalopathy in a patient with liver failure: Clinical case report.

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Zhao, Pan; Zhao, Yanling; Wei, Zhenman; Chen, Jing; Yan, Lilong

2016-07-01

Early recognition and diagnosis of Wernicke encephalopathy is pivotal for the prognosis of this medical emergency, especially in patients with liver failure which predisposes individuals to develop hepatic encephalopathy. For these patients, distinguishing between hepatic encephalopathy and Wernicke encephalopathy is a challenge in real-world clinical practice.A male patient with 21-year medical history of liver cirrhosis presented diarrhea and ascites. One month before this visit, he was noted to have poor appetite and progressive fatigue. After admission, although several major symptoms, including diarrhea, ascites, hyponatremia, and hypoproteinemia, were greatly improved through appropriate treatments, his laboratory indicators were not changed much. His appetite was not reversed at discharge. On the 5th day after discharge, the patient suddenly became reluctant to speak and did not remember the recent happenings. Simultaneously, unsteady gait and strabismus occurred. On the basis of clinical manifestations and brain magnetic resonance imaging scan results, the patient was diagnosed as Wernicke encephalopathy and these relative symptoms were resolved after intravenous vitamin B1.To our knowledge, this is the second case report of Wernicke encephalopathy developing in a critically ill cirrhotic patient without hepatocellular carcinoma or operative intervention. Wernicke encephalopathy may be underdiagnosed in these patients and this case raises physicians' awareness of its possible onset.

Development and clinical application of In Vivo dosimetry for radiotherapy

International Nuclear Information System (INIS)

Honda, Hirofumi; Oita, Masataka; Tominaga, Masahide; Oto, Yoshihiro

2016-01-01

In practical radiotherapy, it is important to deliver radiation to the target correctly and safely according to the treatment planning. The control of radiation dose delivered to each patient in radiotherapy mainly relies on the prediction based on the result of pre-treatment verification and irradiation accuracy of treatment machines. In Vivo dosimetry in radiotherapy is the procedure of quality assurance by the way of direct measurement for the patient whether the calculated prescribed dose in the treatment planning is delivered precisely. The history of In Vivo dosimetry is relatively long, and the TLD dosimetry for clinical radiotherapy started in early 1970's. After 1980's, owing to the development of semiconductor devices such as diode detectors, semiconductor arrays, the clinical applications for the dosimetry and diagnostic radiation imaging devices which contributed to the development of electric portal imaging devices and 2D semiconductor detectors were introduced. In recent years, these radiation measurement devices and non-invasive methods have been developed, they are becoming widespread as clinical practice. In this paper, we reviewed the In Vivo dosimetry devices and their characteristics, and technical application for radiotherapy. (author)

Involving South Asian patients in clinical trials.

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Hussain-Gambles, M; Leese, B; Atkin, K; Brown, J; Mason, S; Tovey, P

2004-10-01

. Important decisions, such as participation in clinical trials, are likely to be made by those family members who are fluent in English and younger. Social class appears to be more important than ethnicity, and older South Asian people and those from working class backgrounds appear to be more mistrustful. Approachable patients (of the same gender, social class and fluent in English) tend to be 'cherry picked' to clinical trials. This practice was justified because of a lack of time and resources and inadequate support. South Asian patients might be systematically excluded from trials owing to the increased cost and time associated with their inclusion, particularly in relation to the language barrier. Under-representation might also be due to passive exclusion associated with cultural stereotypes. Other characteristics such as gender, age, educational level and social class can also affect trial inclusion. Effective strategies for South Asian recruitment to clinical trials include: using multi-recruitment strategies; defining the demographic and social profiles of the population to be included; using focus groups to identify any potential barriers; consulting representative community members to provide assistance in the study; ensuring eligibility criteria are set as wide as possible; developing educational and recruitment approaches to attract ethnic minority health professionals; ensuring health professionals are adequately trained in culturally and ethnically orientated service provision; determining the most effective mass media to use in study promotion and recruitment; and targeting inner-city, single-handed practices likely to have high ethnic minority populations. Future research should consider: responses when invited to participate; the role of methodological and organisational barriers to recruitment; the complexities of recruitment from a health professional perspective; developing culturally sensitive research methods; the magnitude of the problem of under

Developments in clinical trials: a Pharma Matters report.

Science.gov (United States)

Arjona, A; Nuskey, B; Rabasseda, X; Arias, E

2014-08-01

As the pharmaceutical industry strives to meet the ever-increasing complexity of drug development, new technology in clinical trials has become a beacon of hope. With big data comes the promise of accelerated patient recruitment, real-time monitoring of clinical trials, bioinformatics empowerment of quicker phase progression, and the overwhelming benefits of precision medicine for select trials. Risk-based monitoring stands to benefit as well. With a strengthening focus on centralized data by the FDA and industry's transformative initiative, TransCelerate, a new era in trial risk mitigation has begun. The traditional method of intensive on-site monitoring is becoming a thing of the past as statistical, real-time analysis of site and trial-wide data provides the means to monitor with greater efficiency and effectiveness from afar. However, when it comes to big data, there are challenges that lie ahead. Patient privacy, commercial investment protection, technology woes and data variability are all limitations to be met with considerable thought. At the Annual Meeting of the American Academy of Dermatology this year, clinical trials on psoriasis, atopic dermatitis and other skin diseases were discussed in detail. This review of clinical research reports on novel therapies for psoriasis and atopic dermatitis reveals the impact of these diseases and the drug candidates that have been successful in phase II and III studies. Data-focused highlights of novel dermatological trials, as well as real-life big data approaches and an insight on the new methodology of risk-based monitoring, are all discussed in this edition of Developments in Clinical Trials. Copyright 2014 Prous Science, S.A.U. or its licensors. All rights reserved.

Evidence of clinical utility: an unmet need in molecular diagnostics for patients with cancer.

Science.gov (United States)

Parkinson, David R; McCormack, Robert T; Keating, Susan M; Gutman, Steven I; Hamilton, Stanley R; Mansfield, Elizabeth A; Piper, Margaret A; Deverka, Patricia; Frueh, Felix W; Jessup, J Milburn; McShane, Lisa M; Tunis, Sean R; Sigman, Caroline C; Kelloff, Gary J

2014-03-15

This article defines and describes best practices for the academic and business community to generate evidence of clinical utility for cancer molecular diagnostic assays. Beyond analytical and clinical validation, successful demonstration of clinical utility involves developing sufficient evidence to demonstrate that a diagnostic test results in an improvement in patient outcomes. This discussion is complementary to theoretical frameworks described in previously published guidance and literature reports by the U.S. Food and Drug Administration, Centers for Disease Control and Prevention, Institute of Medicine, and Center for Medical Technology Policy, among others. These reports are comprehensive and specifically clarify appropriate clinical use, adoption, and payer reimbursement for assay manufacturers, as well as Clinical Laboratory Improvement Amendments-certified laboratories, including those that develop assays (laboratory developed tests). Practical criteria and steps for establishing clinical utility are crucial to subsequent decisions for reimbursement without which high-performing molecular diagnostics will have limited availability to patients with cancer and fail to translate scientific advances into high-quality and cost-effective cancer care. See all articles in this CCR Focus section, "The Precision Medicine Conundrum: Approaches to Companion Diagnostic Co-development." ©2014 AACR.

Should we systematically test patients with clinically isolated syndrome for auto-antibodies?

Science.gov (United States)

Negrotto, Laura; Tur, Carmen; Tintoré, Mar; Arrambide, Georgina; Sastre-Garriga, Jaume; Río, Jordi; Comabella, Manuel; Nos, Carlos; Galán, Ingrid; Vidal-Jordana, Angela; Simon, Eva; Castilló, Joaquín; Palavra, Filipe; Mitjana, Raquel; Auger, Cristina; Rovira, Àlex; Montalban, Xavier

2015-12-01

Several autoimmune diseases (ADs) can mimic multiple sclerosis (MS). For this reason, testing for auto-antibodies (auto-Abs) is often included in the diagnostic work-up of patients with a clinically isolated syndrome (CIS). The purpose was to study how useful it was to systematically determine antinuclear-antibodies, anti-SSA and anti-SSB in a non-selected cohort of CIS patients, regarding the identification of other ADs that could represent an alternative diagnosis. From a prospective CIS cohort, we selected 772 patients in which auto-Ab levels were tested within the first year from CIS. Baseline characteristics of auto-Ab positive and negative patients were compared. A retrospective revision of clinical records was then performed in the auto-Ab positive patients to identify those who developed ADs during follow-up. One or more auto-Ab were present in 29.4% of patients. Only 1.8% of patients developed other ADs during a mean follow-up of 6.6 years. In none of these cases the concurrent AD was considered the cause of the CIS. In all cases the diagnosis of the AD resulted from the development of signs and/or symptoms suggestive of each disease. Antinuclear-antibodies, anti-SSA and anti-SSB should not be routinely determined in CIS patients but only in those presenting symptoms suggestive of other ADs. © The Author(s), 2015.

Clinical characteristics of impulse control and related disorders in Chinese Parkinson's disease patients.

Science.gov (United States)

Zhang, Yu; He, An Qi; Li, Lin; Chen, Wei; Liu, Zhen Guo

2017-05-18

Impulse control and related disorders (ICRDs) are clinically complications in Parkinson's disease (PD). However, the clinical characteristics of ICRDs in Chinese PD patients were rarely reported. We aimed to explore the prevalence and the clinical profile of ICRDs in Chinese patients with PD. 142 Chinese PD patients were consecutively enrolled. The symptoms of ICRDs were assessed with the Questionnaire for Impulsive-Compulsive Disorders. The clinical characteristics of patients with ICRDs and without ICRDs were compared. ICRDs were present in 31% of our patients. The most common ICRDs were compulsive medication use (11.3%) and punding (9.2%); the least frequent were walkabout (1.4%). Variables independently associated with ICRDs were earlier onset of the disease (≤55 years), severe cognitive impairment (MMSE 10-20), the dose of dopamine agonist (>1 mg/d) and dyskinesia. ICRDs was commonly found in Chinese PD patients. Earlier onset of the disease, the dose of dopamine agonist, severe cognitive impairment and dyskinesia are independent factors associated with ICRDs. Our results will be benefit for clinicians to assess the risk of developing ICRDs before delivering dopaminergic medication.

Design of clinical trials for therapeutic cancer vaccines development.

Science.gov (United States)

Mackiewicz, Jacek; Mackiewicz, Andrzej

2009-12-25

Advances in molecular and cellular biology as well as biotechnology led to definition of a group of drugs referred to as medicinal products of advanced technologies. It includes gene therapy products, somatic cell therapeutics and tissue engineering. Therapeutic cancer vaccines including whole cell tumor cells vaccines or gene modified whole cells belong to somatic therapeutics and/or gene therapy products category. The drug development is a multistep complex process. It comprises of two phases: preclinical and clinical. Guidelines on preclinical testing of cell based immunotherapy medicinal products have been defined by regulatory agencies and are available. However, clinical testing of therapeutic cancer vaccines is still under debate. It presents a serious problem since recently clinical efficacy of the number of cancer vaccines has been demonstrated that focused a lot of public attention. In general clinical testing in the current form is very expensive, time consuming and poorly designed what may lead to overlooking of products clinically beneficial for patients. Accordingly regulatory authorities and researches including Cancer Vaccine Clinical Trial Working Group proposed three regulatory solutions to facilitate clinical development of cancer vaccines: cost-recovery program, conditional marketing authorization, and a new development paradigm. Paradigm includes a model in which cancer vaccines are investigated in two types of clinical trials: proof-of-principle and efficacy. The proof-of-principle trial objectives are: safety; dose selection and schedule of vaccination; and demonstration of proof-of-principle. Efficacy trials are randomized clinical trials with objectives of demonstrating clinical benefit either directly or through a surrogate. The clinical end points are still under debate.

Discriminating active from latent tuberculosis in patients presenting to community clinics.

Directory of Open Access Journals (Sweden)

Gurjinder Sandhu

Full Text Available Because of the high global prevalence of latent TB infection (LTBI, a key challenge in endemic settings is distinguishing patients with active TB from patients with overlapping clinical symptoms without active TB but with co-existing LTBI. Current methods are insufficiently accurate. Plasma proteomic fingerprinting can resolve this difficulty by providing a molecular snapshot defining disease state that can be used to develop point-of-care diagnostics.Plasma and clinical data were obtained prospectively from patients attending community TB clinics in Peru and from household contacts. Plasma was subjected to high-throughput proteomic profiling by mass spectrometry. Statistical pattern recognition methods were used to define mass spectral patterns that distinguished patients with active TB from symptomatic controls with or without LTBI.156 patients with active TB and 110 symptomatic controls (patients with respiratory symptoms without active TB were investigated. Active TB patients were distinguishable from undifferentiated symptomatic controls with accuracy of 87% (sensitivity 84%, specificity 90%, from symptomatic controls with LTBI (accuracy of 87%, sensitivity 89%, specificity 82% and from symptomatic controls without LTBI (accuracy 90%, sensitivity 90%, specificity 92%.We show that active TB can be distinguished accurately from LTBI in symptomatic clinic attenders using a plasma proteomic fingerprint. Translation of biomarkers derived from this study into a robust and affordable point-of-care format will have significant implications for recognition and control of active TB in high prevalence settings.

Development of a Post-Graduate Year 2 Pharmacy Residency in Clinical Pharmacogenetics

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Hoffman, James M.; Gammal, Roseann S.; Relling, Mary V.; Crews, Kristine R.

2017-01-01

Purpose The structure and development of an innovative clinical pharmacogenetics post-graduate year 2 (PGY2) ASHP-accredited residency program is described. Summary The advent of the era of genomics has left practitioners wondering how to interpret the data obtained from sequencing and genotyping patients. In order to train the next leaders in the area of implementing pharmacogenetics, St. Jude Children’s Research Hospital established the first accredited residency program in clinical pharmacogenetics. The 12-month long PGY2 residency was created in accordance with the ASHP standards for advanced practice residencies. The resident learns to optimize patient outcomes through the expert provision of evidence-based, patient-centered precision medicine as an integral part of an interdisciplinary team. The resident gains hands-on experience in a dynamic environment regarding all aspects of running a clinical pharmacogenetics service. Since the first resident graduated in 2012, the program has graduated one resident each year. Conclusion To fill a need for pharmacists trained in pharmacogenetics, an innovative PGY2 residency in clinical pharmacogenetics was successfully developed. Upon completion of the program, residents are equipped with the clinical skills and necessary experience to drive precision medicine forward and lead the implementation of pharmacogenetics in various healthcare settings. PMID:28274984

Development and testing of an objective structured clinical exam (OSCE) to assess socio-cultural dimensions of patient safety competency

Science.gov (United States)

Ginsburg, Liane R; Tregunno, Deborah; Norton, Peter G; Smee, Sydney; de Vries, Ingrid; Sebok, Stefanie S; VanDenKerkhof, Elizabeth G; Luctkar-Flude, Marian; Medves, Jennifer

2015-01-01

Background Patient safety (PS) receives limited attention in health professional curricula. We developed and pilot tested four Objective Structured Clinical Examination (OSCE) stations intended to reflect socio-cultural dimensions in the Canadian Patient Safety Institute's Safety Competency Framework. Setting and participants 18 third year undergraduate medical and nursing students at a Canadian University. Methods OSCE cases were developed by faculty with clinical and PS expertise with assistance from expert facilitators from the Medical Council of Canada. Stations reflect domains in the Safety Competency Framework (ie, managing safety risks, culture of safety, communication). Stations were assessed by two clinical faculty members. Inter-rater reliability was examined using weighted κ values. Additional aspects of reliability and OSCE performance are reported. Results Assessors exhibited excellent agreement (weighted κ scores ranged from 0.74 to 0.82 for the four OSCE stations). Learners’ scores varied across the four stations. Nursing students scored significantly lower (p<0.05) than medical students on three stations (nursing student mean scores=1.9, 1.9 and 2.7; medical student mean scores=2.8, 2.9 and 3.5 for stations 1, 2 and 3, respectively where 1=borderline unsatisfactory, 2=borderline satisfactory and 3=competence demonstrated). 7/18 students (39%) scored below ‘borderline satisfactory’ on one or more stations. Conclusions Results show (1) four OSCE stations evaluating socio-cultural dimensions of PS achieved variation in scores and (2) performance on this OSCE can be evaluated with high reliability, suggesting a single assessor per station would be sufficient. Differences between nursing and medical student performance are interesting; however, it is unclear what factors explain these differences. PMID:25398630

An official American thoracic society workshop report: developing performance measures from clinical practice guidelines.

Science.gov (United States)

Kahn, Jeremy M; Gould, Michael K; Krishnan, Jerry A; Wilson, Kevin C; Au, David H; Cooke, Colin R; Douglas, Ivor S; Feemster, Laura C; Mularski, Richard A; Slatore, Christopher G; Wiener, Renda Soylemez

2014-05-01

Many health care performance measures are either not based on high-quality clinical evidence or not tightly linked to patient-centered outcomes, limiting their usefulness in quality improvement. In this report we summarize the proceedings of an American Thoracic Society workshop convened to address this problem by reviewing current approaches to performance measure development and creating a framework for developing high-quality performance measures by basing them directly on recommendations from well-constructed clinical practice guidelines. Workshop participants concluded that ideally performance measures addressing care processes should be linked to clinical practice guidelines that explicitly rate the quality of evidence and the strength of recommendations, such as the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) process. Under this framework, process-based performance measures would only be developed from strong recommendations based on high- or moderate-quality evidence. This approach would help ensure that clinical processes specified in performance measures are both of clear benefit to patients and supported by strong evidence. Although this approach may result in fewer performance measures, it would substantially increase the likelihood that quality-improvement programs based on these measures actually improve patient care.

Challenges of developing and conducting clinical trials in rare disorders.

Science.gov (United States)

Kempf, Lucas; Goldsmith, Jonathan C; Temple, Robert

2018-04-01

Rare disease drug development is a rapidly expanding field. Clinical researchers in rare diseases face many challenges when conducting trials in small populations. Disease natural history is often poorly understood and the ability to detect clinically meaningful outcomes requires understanding of their rate of occurrence and variability, both of which contribute to difficulties in powering a study. Standard trial designs are not optimized to obtain adequate safety and efficacy data from small numbers of patients, so alternative designs (enrichment, crossover, adaptive, N-of 1) need to be considered. The affected patients can be hard to identify, especially early in the course of their disease, are generally geographically dispersed, and are often children. Trials are frequently conducted on an international scale and may be subject to complex or multiple regulatory agency oversights and may be affected by local customs, cultures, and practices. A basic understanding of the FDA programs supporting development of drugs for rare diseases is provided by this review and the role of early consultation with the FDA is emphasized. Of recent FDA New Molecular Entities (NME) approvals, 41% (17 approvals) in 2014, 47% (21 approvals) in 2015, and 41% (9 approvals) in 2016 were for rare disease indications. Through effective interactions and collaborations with physicians, institutions, and patient groups, sponsors have been successful in bringing new treatments to market for individuals affected by rare diseases. Challenges to drug development have been overcome through the focused efforts of patients/families, non-profit patient advocacy groups, drug developers, and regulatory authorities. © 2017 Wiley Periodicals, Inc.

Clinical supervision of nurses working with patients with borderline personality disorder.

Science.gov (United States)

Bland, Ann R; Rossen, Eileen K

2005-06-01

Some nurses describe individuals diagnosed with borderline personality disorder (BPD) as among the most challenging and difficult patients encountered in their practice. As a result, the argument has been made for nursing staff to receive clinical supervision to enhance therapeutic effectiveness and treatment outcomes for individuals with BPD. Formal clinical supervision can focus on the stresses of working in a demanding environment within the work place and enable nurses to accept accountability for their own practice and development (Pesut & Herman, 1999). A psychiatric-mental health clinical nurse specialist can provide individual and/or group supervision for the nursing staff, including education about patient dynamics, staff responses, and treatment team decisions. A clinical nurse specialist also can provide emotional support to nursing staff, which enhances job satisfaction, as they struggle to maintain professional therapeutic behavior with these individuals.

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

Science.gov (United States)

Patrick-Lake, Bray

2018-02-01

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

MRI features of patients with heroin spongiform leukoencephalopathy of different clinical stages

International Nuclear Information System (INIS)

Shi Zhu; Pan Suyue; Zhou Liang; Dong Zhao; Lu Bingxun

2007-01-01

Objective: To investigate radiological features of patients with heroin spongiform leukoencephalopathy (HSLE) of different clinical stages and discuss the evolutional characteristics of the disease. Methods: Thirty two patients with HSLE underwent precontrast MRI and postcontrast MRI. The history of addiction, clinical presentations, and brain MRI were analyzed and summarized according to the patient's clinical staging. There are 6 cases in I stage, 21 cases in II stage, 5 cases in III stage. Results: All patients had history of heroin vapor inhalation. Most of the cases developed subacute cerebellar impairment in earlier period. Brain MRI revealed symmetrical lesion within bilateral cerebellum in all patients. Splenium of the corpus callosum, posterior limb of the internal capsule, deep white matter of the occipital and parietal lobes, were gradually involved with progressive deterioration of HSLE. The brain stem and deep white matter of the frontal and temporal lobes were involved in some cases. Conclusions: The history of heated heroin vapor inhalation was the prerequisite for the diagnosis of HSLE. Brain MRI presented the characteristic lesion and its evolution of HSLE. Brain MRI was very important for accurate diagnosis and helpful to judge the clinical stages according to the involved brain region. (authors)

Lower back pain: clinical features and examination of patients

Directory of Open Access Journals (Sweden)

I.V. Damulin

2014-01-01

Full Text Available This article discusses the clinical and paraclinical aspects of pain syndromes of the lumbosacral localization. The past medical history (including the working conditions of the patient and the presence of constant stress, physical and paraclinical examination, and assessment of psychological condition are important for establishing the correct diagnosis. It should be noted that there is no strict parallelism between the presence of back pain and the results of paraclinical examination of the spine. Therefore, the comprehensive assessment of the patient's clinical status, including the state of the musculoskeletal system, has a leading value for correct diagnosis and selection of therapy. Increasing pain when coughing or sneezing is noted in patients with discogenic pain syndromes; the development of pain along the root innervation often occurs simultaneously with the reduction of localized pain in the lumbar region. The diagnostic value of the radiography and neuroimaging data is unquestioned; however, these methods allow one to evaluate mainly the anatomical rather than pathophysiological changes. The direct dependence between the anatomical changes and the clinical situation is not typical of back pain. Magnetic resonance imaging (MRI is when the injury level is unclear and the clinical examination data indicate pathology of the spinal cord or soft tissues. Moreover, MRI data help either to eliminate or confirm a tumor or the inflammatory nature of the pain syndrome. MRI is also an informative method in patients who have undergone surgery for vertebral pathology. Computed tomography is an effective diagnosis method only in those cases where the symptomatology clearly indicates the injury level and the bone changes are the pain cause with a high degree of probability. Electromyography (EMG is very informative in patients with radiculopathies; it allows one to evaluate the pathophysiological changes in such patients. However, there usually is

Development of innovative teaching materials: clinical pharmacology problem-solving (CPPS) units: comparison with patient-oriented problem-solving units and problem-based learning--a 10-year review.

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Lathers, Claire M; Smith, Cedric M

2002-05-01

The First Teaching Clinic in Clinical Pharmacology, sponsored by the American College of Clinical Pharmacology in September 1992, was designed for the preparation and development of new clinical pharmacology problem-solving (CPPS) units. CPPS units are case histories that illustrate pertinent principles in clinical pharmacology. Each unit consists of the following sections: introduction, learning objectives, pretest, four clinical pharmacology scenarios, posttest, answers to pre- and posttest questions, and selected references. The clinical pharmacology content of the CPPS units place greater emphasis on clinical information, drug selection, and risk/benefit analyses, and thus they complement the basic pharmacology presented in the patient-oriented problem-solving (POPS) units. In general, the CPPS units are intended for use by students more advanced in clinical pharmacology than first- and second-year medical students. The CPPS unit "Clinical Pharmacology of Antiepileptic Drug Use: Clinical Pearls about the Perils of Patty" was developed for use by third- and fourth-year medical students doing rotations in neurology or clinical pharmacology; advanced pharmacy students; residents in neurology, pediatrics, internal medicine, and family practice; fellows in clinical pharmacology, and those taking the board examination in clinical pharmacology. The CPPS unit titled "Geriatric Clinical Psychopharmacology" was written for third- and fourth-year medical students; residents in psychiatry, family practice, and internal medicine;fellows in clinical pharmacology; and those studying for boards in clinical pharmacology. The CPPS unit "Anisocoria and Glaucoma" was written for more advanced students of clinical pharmacology. The CPPS unit titled "Antiepileptic Drugs" was intended for second-year medical students. The second teaching clinic was held in November 1993 and focused on the development and editing of the CPPS units and their evaluations by faculty and students from

Patient participation in clinical decision-making in nursing: A comparative study of nurses' and patients' perceptions.

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Florin, Jan; Ehrenberg, Anna; Ehnfors, Margareta

2006-12-01

The aim of this study was to compare the degree of concordance between patients and Registered Nurses' perceptions of the patients' preferences for participation in clinical decision-making in nursing care. A further aim was to compare patients' experienced participation with their preferred participatory role. Patient participation in clinical decision-making is valuable and has an effect on quality of care. However, there is limited knowledge about patient preferences for participation and how nurses perceive their patients' preferences. A comparative design was adopted with a convenient sample of 80 nurse-patient dyads. A modified version of the Control Preference Scale was used in conjunction with a questionnaire developed to elicit the experienced participation of the patient. A majority of the Registered Nurses perceived that their patients preferred a higher degree of participation in decision-making than did the patients. Differences in patient preferences were found in relation to age and social status but not to gender. Patients often experienced having a different role than what was initially preferred, e.g. a more passive role concerning needs related to communication, breathing and pain and a more active role related to activity and emotions/roles. Registered Nurses are not always aware of their patients' perspective and tend to overestimate patients' willingness to assume an active role. Registered Nurses do not successfully involve patients in clinical decision-making in nursing care according to their own perceptions and not even to the patients' more moderate preferences of participation. A thorough assessment of the individual's preferences for participation in decision-making seems to be the most appropriate approach to ascertain patient's involvement to the preferred level of participation. The categorization of patients as preferring a passive role, collaborative role or active role is seen as valuable information for Registered Nurses to

Developing Clinical Competence

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P.F. Wimmers (Paul)

2006-01-01

textabstractThe development of clinical competence is the main purpose of medical education. The long road to become clinically competent starts on the first day of medical school, and every institution strives to select the best students. The responsibility of medical schools is to train

Protecting patient privacy when sharing patient-level data from clinical trials.

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Tucker, Katherine; Branson, Janice; Dilleen, Maria; Hollis, Sally; Loughlin, Paul; Nixon, Mark J; Williams, Zoë

2016-07-08

Greater transparency and, in particular, sharing of patient-level data for further scientific research is an increasingly important topic for the pharmaceutical industry and other organisations who sponsor and conduct clinical trials as well as generally in the interests of patients participating in studies. A concern remains, however, over how to appropriately prepare and share clinical trial data with third party researchers, whilst maintaining patient confidentiality. Clinical trial datasets contain very detailed information on each participant. Risk to patient privacy can be mitigated by data reduction techniques. However, retention of data utility is important in order to allow meaningful scientific research. In addition, for clinical trial data, an excessive application of such techniques may pose a public health risk if misleading results are produced. After considering existing guidance, this article makes recommendations with the aim of promoting an approach that balances data utility and privacy risk and is applicable across clinical trial data holders. Our key recommendations are as follows: 1. Data anonymisation/de-identification: Data holders are responsible for generating de-identified datasets which are intended to offer increased protection for patient privacy through masking or generalisation of direct and some indirect identifiers. 2. Controlled access to data, including use of a data sharing agreement: A legally binding data sharing agreement should be in place, including agreements not to download or further share data and not to attempt to seek to identify patients. Appropriate levels of security should be used for transferring data or providing access; one solution is use of a secure 'locked box' system which provides additional safeguards. This article provides recommendations on best practices to de-identify/anonymise clinical trial data for sharing with third-party researchers, as well as controlled access to data and data sharing

Validation of the Mayo Clinic Staging System in Determining Prognoses of Patients With Perihilar Cholangiocarcinoma

NARCIS (Netherlands)

Coelen, Robert J. S.; Gaspersz, Marcia P.; Labeur, Tim A.; van Vugt, Jeroen L. A.; van Dieren, Susan; Willemssen, François E. J. A.; Nio, Chung Y.; Ijzermans, Jan N. M.; Klümpen, Heinz-Josef; Groot Koerkamp, Bas; van Gulik, Thomas M.

2017-01-01

BACKGROUND & AIMS: Most systems for staging perihilar cholangiocarcinoma (PHC) have been developed for the minority of patients with resectable disease. The recently developed Mayo Clinic system for staging PHC requires only clinical and radiologic variables, but has not yet been validated. We

Clinical audit: Development of the criteria of good practices

International Nuclear Information System (INIS)

Soimakallio, S.; Alanen, A.; Jaervinen, H.; Ahonen, A.; Ceder, K.; Lyyra-Laitinen, T.; Paunio, M.; Sinervo, T.; Wigren, T.

2011-01-01

Clinical audit is a systematic review of the procedures in order to improve the quality and the outcome of patient care, whereby the procedures are examined against agreed standards for good medical Radiological procedures. The criteria of good procedures (i.e. the good practice) are thus the cornerstones for development of clinical audits: these should be the basis of assessments regardless of the type of the audit-external, internal, comprehensive or partial. A lot of criteria for good practices are available through the recommendations and publications by international and national professional societies and other relevant organisations. For practical use in clinical audits, the criteria need to be compiled, sorted out and agreed on for the particular aims of an audit (comprehensive or partial, external or internal). The national professional and scientific societies can provide valuable contribution to this development. For examination-or treatment-specific criteria- preliminary consensus needs to be obtained with the help of clinical experts, while clinical audits can be useful as a benchmarking tool to improve the criteria. (authors)

Developing clinical guidelines: how much rigour is required?

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Haroon, Munib; Ranmal, Rita; McElroy, Helen; Dudley, Jan

2015-04-01

Clinical guidelines that are rigorously developed play a fundamental role in improving healthcare and reducing unnecessary variations in practice. National guidelines are increasingly used by healthcare professionals, patients and commissioners; however, national bodies are unable to meet the demand for guidance on all topics. There are fewer resources available for guidance produced locally or by specialty groups, and it is necessary to achieve a balance between pragmatism and rigour while conforming to the widely accepted norms of what constitutes a good guideline. This paper introduces the key concepts around this topic with suggestions for those interested in developing their own guideline. An example of challenges encountered in generating high-quality clinical guidance is given in box 1. Box 1 Challenges in guideline development Professor Johnson runs a local developmental paediatrics service with eight other colleagues. All have different ways of managing children with PAVING syndrome. This was difficult for patients and staff and has led to disagreements on how certain patients should be managed. As a result, Professor Johnson developed a Guideline Development Group to look at the management of PAVING syndrome. The group identified 12 clinical questions (including diagnosis, exclusion of comorbidities, treatment modalities), searched the PubMed database and found some useful evidence that they used to formulate key recommendations. For one question about behavioural therapy, PubMed did not suggest any evidence so they informally arrived at a consensus among themselves and wrote up their guideline. On the back of this success, they applied for the guideline to be endorsed or supported by the Royal College of Paediatrics and Child Health (RCPCH). To their frustration, it was turned down on methodological grounds. Professor Johnson wrote to the RCPCH saying that he was "pretty peeved that the PAVING syndrome guideline had been rejected" for the College

[Feedback on the evaluation of clinical pharmacy activities developed in surgery].

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Jarfaut, A; Clauzel-Montserrat, M; Vigouroux, D; Kehrli, P; Gaudias, J; Kempf, J-F; Levêque, D; Nivoix, Y; Gourieux, B

2015-03-01

Our current development strategy integrates clinical pharmacy activities prioritized in surgical services. Patients in these services are typically risk patients: transfers, multiple prescribers, frequent medication change, pharmacotherapeutic risk classes. Three clinical pharmacy activities (admission reconciliation, pharmaceutical analysis, participation doctors round) have been developed in orthopaedic surgery and neurosurgery. Pharmacists prospectively recorded data describing their activities: number of reconciliations and analyzed requirements and time required to achieve them. Data on pharmaceutical interventions were recorded on the basis ActIP®. The clinical significance of interventions was retrospectively rated by a team of two pharmacists and two physicians on the scale adapted Hatoum et al. Four thousand five hundred pharmaceutical analysis and 248 reconciliations were conducted. One hundred and fifty-six pharmaceutical interventions were issued. The average acceptance rate was 80%. A total of 5.8% of pharmaceutical interventions have been listed with a very significant clinical importance and 48.1% with at least significant clinical importance. The activities and documentation required pharmaceutical average daily time (senior pharmacist, resident and external pharmacist) about 6 hours. Other studies, including comparative and medico-economic, must be conducted to support these results. Nevertheless, the indicators obtained attend a better readability of the clinical importance of the activities performed by clinical pharmacists and this particularly in surgical services, both by prescribers and authorities. Copyright © 2014 Elsevier Masson SAS. All rights reserved.

Added value of involving patients in the first step of multidisciplinary guideline development: a qualitative interview study among infertile patients.

Science.gov (United States)

den Breejen, Elvira M E; Hermens, Rosella P M G; Galama, Wienke H; Willemsen, Wim N P; Kremer, Jan A M; Nelen, Willianne L D M

2016-06-01

Patient involvement in scoping the guideline is emphasized, but published initiatives actively involving patients are generally limited to the writing and reviewing phase. To assess patients' added value to the scoping phase of a multidisciplinary guideline on infertility. Qualitative interview study. We conducted interviews among 12 infertile couples and 17 professionals. We listed and compared the couples' and professionals' key clinical issues (=care aspects that need improvement) to be addressed in the guideline according to four domains: current guidelines, professionals, patients and organization of care. Main key clinical issues suggested by more than three quarters of the infertile couples and/or at least two professionals were identified and compared. Overall, we identified 32 key clinical issues among infertile couples and 23 among professionals. Of the defined main key clinical issues, infertile couples mentioned eight issues that were not mentioned by the professionals. These main key clinical issues mainly concerned patient-centred (e.g. poor information provision and poor alignment of care) aspects of care on the professional and organizational domain. Both groups mentioned two main key clinical issues collectively that were interpreted differently: the lack of emotional support and respect for patients' values. Including patients from the first phase of the guideline development process leads to valuable additional main key clinical issues for the next step of a multidisciplinary guideline development process and broadens the scope of the guideline, particularly regarding patient-centredness and organizational issues from a patients' perspective. © The Author 2016. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Developing advanced clinical practice skills in gastrointestinal consequences of cancer treatment.

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Gee, Caroline; Andreyev, Jervoise; Muls, Ann

2018-03-08

This article explores the transition from a clinical nurse specialist (CNS) towards developing advanced clinical practice skills within a gastrointestinal consequences of cancer clinic. It presents data on the first 50 patients assessed by the CNS from a prospective service evaluation, demonstrating how this informed the nurse's future learning. There is high demand for advanced clinical practice skills to address unmet health needs and improve the quality, efficiency, and sustainability of healthcare services. However, a literature review found no literature on developing advanced clinical practice skills in this setting. Emerging themes from the service evaluation focused on barriers and enablers, ongoing support, organisational commitment and working in a multidisciplinary team. Blended learning provided both structured and opportunistic learning, embedding both formal and tacit knowledge, as roles require increasing flexibility. Clinical supervision and reflective practice were key in maintaining professional and peer support.

Tracing the evolution of chiropractic students’ confidence in clinical and patient communication skills during a clinical internship: a multi-methods study

Science.gov (United States)

2012-01-01

Background Anecdotal evidence points to variations in individual students’ evolving confidence in clinical and patient communication skills during a clinical internship. A better understanding of the specific aspects of internships that contribute to increasing or decreasing confidence is needed to best support students during the clinical component of their study. Methods A multi-method approach, combining two large-scale surveys with 269 students and three in-depth individual interviews with a sub-sample of 29 students, was used to investigate the evolution of change in student confidence during a 10-month long internship. Change in levels of confidence in patient communication and clinical skills was measured and relationship to demographic factors were explored. The interviews elicited students’ accounts and reflections on what affected the evolution of their confidence during the internship. Results At the start of their internship, students were more confident in their patient communication skills than their clinical skills but prior experience was significantly related to confidence in both. Initial confidence in patient communication skills was also related to age and prior qualification but not gender whilst confidence in clinical skills was related to gender but not age or prior qualification. These influences were maintained over time. Overall, students’ levels of confidence in patient communication and clinical skills confidence increased significantly over the duration of the internship with evidence that change over time in these two aspects were inter-related. To explore how specific aspects of the internship contributed to changing levels of confidence, two extreme sub-groups of interviewees were identified, those with the least increase and those with the highest increase in professional confidence over time. A number of key factors affecting the development of confidence were identified, including among others, interactions with clinicians

Tracing the evolution of chiropractic students' confidence in clinical and patient communication skills during a clinical internship: a multi-methods study.

Science.gov (United States)

Hecimovich, Mark; Volet, Simone

2012-06-19

Anecdotal evidence points to variations in individual students' evolving confidence in clinical and patient communication skills during a clinical internship. A better understanding of the specific aspects of internships that contribute to increasing or decreasing confidence is needed to best support students during the clinical component of their study. A multi-method approach, combining two large-scale surveys with 269 students and three in-depth individual interviews with a sub-sample of 29 students, was used to investigate the evolution of change in student confidence during a 10-month long internship. Change in levels of confidence in patient communication and clinical skills was measured and relationship to demographic factors were explored. The interviews elicited students' accounts and reflections on what affected the evolution of their confidence during the internship. At the start of their internship, students were more confident in their patient communication skills than their clinical skills but prior experience was significantly related to confidence in both. Initial confidence in patient communication skills was also related to age and prior qualification but not gender whilst confidence in clinical skills was related to gender but not age or prior qualification. These influences were maintained over time. Overall, students' levels of confidence in patient communication and clinical skills confidence increased significantly over the duration of the internship with evidence that change over time in these two aspects were inter-related. To explore how specific aspects of the internship contributed to changing levels of confidence, two extreme sub-groups of interviewees were identified, those with the least increase and those with the highest increase in professional confidence over time. A number of key factors affecting the development of confidence were identified, including among others, interactions with clinicians and patients, personal agency and

CHRONIC THROMBOEMBOLIC PULMONARY HYPERTENSIA AT THE YOUNG PATIENT. CLINICAL OBSERVATION

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N. A. Kosheleva

2018-01-01

Full Text Available The work purpose — to describe a clinical case of formation and a current of a chronic thromboembolic pulmonary hypertensia (CTEPH at the patient of young age. Materials and methods. The patient P., 26 years, arrived with complaints to the dyspnea arising at rest and amplifying at the minimum exercise stress, edemas of the lower extremities. In the anamnesis — a clottage of subclavial and humeral veins on the right, recurrent PTE. Results. During inspection at the patient an echocardiography signs of a pulmonary hypertensia. According to contrast-enhanced multislice computed tomography in dynamics there was a dissolution of thrombs in a lumen of a pulmonary artery. At the patient data for a thrombophilia or a systemic vasculitis aren’t taped. Conclusion. In this clinical case features of a current and maintaining the patient of young age with CTEPH after the postponed PTE are displayed. The young age, idiopathic and recurrent character of a pulmonary embolism were the contributing risk factors of development of CTEPH. 

Development and content validation of a patient-reported endometriosis pain daily diary.

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van Nooten, Floortje E; Cline, Jennifer; Elash, Celeste A; Paty, Jean; Reaney, Matthew

2018-01-04

Endometriosis is a common gynecological disorder that causes inflammation and pelvic pain. Endometriosis-related pain is best captured with patient-reported outcome (PRO) measures, however, assessment of endometriosis-related pain in clinical trials has been difficult in the absence of a reliable and valid PRO instrument. We describe the development of the Endometriosis Pain Daily Diary (EPDD), an electronic PRO developed as a survey instrument to assess endometriosis-related pain and its impact on patients' lives. The EPDD was initially developed on the basis of an existing Endometriosis Pain and Bleeding Diary, a targeted review of relevant literature, clinical expert interviews, and open-ended (concept elicitation) patient interviews in the United States (US) and Japan which captured patients' experience with endometriosis. Cognitive interviews of patients with endometriosis were conducted to evaluate patient comprehension of the EPDD items. A conceptual model of endometriosis was developed, and meetings with US and European regulatory authorities provided feedback for validating the EPDD in the context of clinical trials. Translatability assessments of the EPDD were conducted to confirm its appropriate interpretation and ease of completion across 17 languages. The iterative development progressed through three versions of the instrument. The EPDDv1 included 18 items relating to dysmenorrhea/pelvic pain, dyspareunia and sexual activity, bleeding, hot flashes, daily activities, and use of rescue medication. The EPDDv2 was a larger 43-item survey tested in cognitive interviews and subsequently revised to yield the current 11-item EPDDv3, consisting of five core items relating to dysmenorrhea, non-menstrual pelvic pain, and dyspareunia, and six extension items relating to sexual activity, daily activities, and use of rescue medication. The EPDD is a PRO for the evaluation of endometriosis-related pain and its associated impacts on patients' lives. The EPDD

Caring touch--patients' experiences in an anthroposophic clinical context.

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Ozolins, Lise-Lotte; Hörberg, Ulrica; Dahlberg, Karin

2015-12-01

This study describes the phenomenon of caring touch from the patients' perspective in an anthroposophic clinical context where caring touch is often used to promote health and alleviate suffering. The aim of the study was to explore and phenomenologically describe the phenomenon of caring touch from the patients' perspectives. The study has been carried out with a Reflective Lifeworld Research approach in order to understand and describe human existential phenomena. Ten female patients were interviewed in an anthroposophic clinic in Sweden. The findings show how caring touch has multifaceted meanings and makes the patients' feel present and anchored in a meaningful context. The patients' feel that they are seen, accepted and confirmed. Furthermore, touch creates a caring space where the patients become receptive for care and has the power to alleviate the patients' suffering, as well as to frighten and cause or worsen the suffering. In order to take advantage of the caring potential, the patient needs to be invited to a respectful and sensitive form of touch. An interpersonal flexible space is necessary where the touch can be effective, and where a dynamic interplay can develop. In conclusion, caring touch is an opportunity for carers to support well-being and health. The carers need to approach their patients in both a sensitive and reflective way. A caring science perspective can serve as a help to further understand touch as a unique caring act. © 2015 Nordic College of Caring Science.

Development of Bioethics and Clinical Ethics in Bulgaria.

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Aleksandrova-Yankulovska, Silviya S

2017-03-01

Bioethics and clinical ethics emerged from the classical medical ethics in the 1970s of the 20th century. Both fields are new for the Bulgarian academic tradition. The aims of this paper were to demarcate the subject fields of medical ethics, bioethics, and clinical ethics, to present the developments in the field of medical ethics in Bulgaria, to delineate the obstacles to effective ethics education of medical professionals, and to present the results of the application of an adapted bottom-up methodology for clinical ethics consultation in several clinical units in Bulgaria. Extended literature review and application of an adapted METAP methodology for clinical ethics consultation in six clinical units in the Northern Bulgaria between May 2013 and December 2014. Teaching of medical ethics in Bulgaria was introduced in the 1990s and still stands mainly as theoretical expertise without sufficient dilemma training in clinical settings. Earlier studies revealed need of clinical ethics consultation services in our country. METAP methodology was applied in 69 ethics meetings. In 31.9% of them non-medical considerations affected the choice of treatment and 34.8% resulted in reaching consensus between the team and the patient. Participants' opinion about the meetings was highly positive with 87.7% overall satisfaction. Development of bioethics in Bulgaria follows recent worldwide trends. Several ideas could be applied towards increasing the effectiveness of ethics education. Results of the ethics meetings lead to the conclusion that it is a successful and well accepted approach for clinical ethics consultation with a potential for wider introduction in our medical practice.

Clinical evaluation of developed product for recovery of immune system in the treatment of cancer patients

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Cho, Chul-Ku; Choi, Soo Yong; Rhyu, Sung Ryeol; Kim, Ki Wha; Kim, Ji Yun; Yun, Na Ra [Korea Institute of Radiological and Medical Sciences, Seoul (Korea, Republic of)

2006-01-15

We evaluate the clinical efficacy of pilot product (HemoHIM) on recovery from hematopoiesis damage in cancer patients who received radiotherapy and chemotherapy. The cancer patients studied were as follows : cancer of the breast(47 intakers and 136 non-intakers), uterine cervix(38 intakers and 73 non-intakers), and head and neck(7 intakers and 15 non-intakers). The clinical efficacy of pilot product(HemoHIM) in cancer patients who received radiotherapy and chemotherapy was analyzed. In breast cancer patients, the number of leukocytes decreased according to duration of treatment in both groups. However, intakers showed a less decreasing trend compared with non-intakers. Especially, under limiting value in range of leukocyte number of intakers was significantly higher than that of non-intakers. This result incicates that HemoHIM reduce the severe leukopenia. Values of lymphocyte in both groups decreased similarly after treatment, and it was similar to that of leukocyte. Values of erythrocyte in both groups decreased similarly after treatment, but the values were within normal range. In cervix cancer patients, the results were similar to that of breast cancer patients. In cancer of head and neck, values of leukocyte slightly decreased according to duration of treatment in both group. However, it needs to collect more subjects continuously because of small number of cancer patients. No toxicological side effects of HemoHIM were observed in serological analysis, and possibility to alleviate fatigue and inflammation was investigated in some cases.

Clinical evaluation of developed product for recovery of immune system in the treatment of cancer patients

International Nuclear Information System (INIS)

Cho, Chul-Ku; Choi, Soo Yong; Rhyu, Sung Ryeol; Kim, Ki Wha; Kim, Ji Yun; Yun, Na Ra

2006-01-01

We evaluate the clinical efficacy of pilot product (HemoHIM) on recovery from hematopoiesis damage in cancer patients who received radiotherapy and chemotherapy. The cancer patients studied were as follows : cancer of the breast(47 intakers and 136 non-intakers), uterine cervix(38 intakers and 73 non-intakers), and head and neck(7 intakers and 15 non-intakers). The clinical efficacy of pilot product(HemoHIM) in cancer patients who received radiotherapy and chemotherapy was analyzed. In breast cancer patients, the number of leukocytes decreased according to duration of treatment in both groups. However, intakers showed a less decreasing trend compared with non-intakers. Especially, under limiting value in range of leukocyte number of intakers was significantly higher than that of non-intakers. This result incicates that HemoHIM reduce the severe leukopenia. Values of lymphocyte in both groups decreased similarly after treatment, and it was similar to that of leukocyte. Values of erythrocyte in both groups decreased similarly after treatment, but the values were within normal range. In cervix cancer patients, the results were similar to that of breast cancer patients. In cancer of head and neck, values of leukocyte slightly decreased according to duration of treatment in both group. However, it needs to collect more subjects continuously because of small number of cancer patients. No toxicological side effects of HemoHIM were observed in serological analysis, and possibility to alleviate fatigue and inflammation was investigated in some cases

Clinical Characteristics of Patients with Sporadic Colorectal Cancer and Primary Cancers of Other Organs

Directory of Open Access Journals (Sweden)

Jung-Yu Kan

2006-11-01

Full Text Available Most cancer patients often neglect the possibility of secondary cancer. Colorectal cancer (CRC is the third leading cause of cancer death in Taiwan. It is important to be aware of the clinical characteristics of double cancer in CRC patients for early diagnosis and treatment. We retrospectively analyzed 1,031 CRC patients who underwent surgical treatment at the Department of Surgery of Kaohsiung Medical University Hospital between January 1998 and December 2004. Among these patients, CRC was accompanied by cancer of other organs in 17 patients (1.65%, either synchronously or metachronously. Therefore, we describe our experience regarding the location of CRC, the clinical symptoms and signs of these patients, the TNM stage, histology, phase, association with other malignancies, interval between cancers and clinical outcomes. Of the 17 patients in whom CRC was accompanied by primary cancer of other organs, there were four synchronous and 13 metachronous multiple cancer patients. Our patient group comprised six men and 11 women with ages ranging from 47 to 88 years (median age, 66 years. The most common location of CRC was the sigmoid colon. Six gastric cancers (35.2% and six breast cancers (35.2% were associated with primary CRC. The remaining six second primary cancers were one lung cancer, one thyroid cancer, one cervical cancer, one ovarian cancer, one skin cancer, and one urinary bladder cancer. Of the 13 metachronous multiple cancer patients, eight patients developed subsequent CRC after primary cancers of other organs, whereas two patients developed a subsequent second primary cancer after CRC. The intervals between the development of metachronous multiple cancers ranged from 2 to 19 years. In this retrospective analysis, breast and gastric cancer patients were at increased risk of developing subsequent secondary CRC. Careful attention should always be paid to the possibility of secondary CRC in treating these cancer patients. Cancer

DEVELOPMENT OF ALOPECIA DURING TREATMENT WITH A TUMOR NECROSIS FACTOR-ALPHA INHIBITOR IN A FEMALE PATIENT WITH PSORIATIC ARTHRITS: A CLINICAL CASE

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R. G. Mukhina

2016-01-01

Full Text Available Objective: to describe a case of the total development of alopecia in a female patient with psoriatic arthritis during treatment with a tumor necrosis factor-αlpha (TNF-α inhibitor. Materials and methods. Patient I., aged 36 years has been followed up at the Kazan’ Center of Rheumatic Diseases and Osteoporosis since 1998. At approximately the same time, the patient noted the appearance of skin eruptions behind the ears, on the skin of the scalp. She was examined by a dermatologist who diagnosed psoriasis. In 2005, she was admitted to Kazan’ Rheumatology Center, City Clinical Hospital Seven, for the development of obvious synovitis of the knee joint and for the inefficiency of therapy with nonsteroidal anti-inflammatory drugs and diagnosed with psoriatic arthritis. During the prescribed therapy with methotrexate 10 mg/week, evident menstrual irregularities were observed in the patient who stopped using the drug herself. The second pregnancy occurred in 2008. Articular syndrome progression and eruptive psoriasis were recorded in the lactation period. After lactation cessation in 2009, she was hospitalized again. Her examination revealed high laboratory activity (erythrocyte sedimentation rate, as high as 40 mm/hr; magnetic resonance imaging of the knee joints showed the signs of bilateral synovitis; lumbar spine radiography exhibited grade II sacroiliitis. Leflunomide 20 mg/day was recommended as a basic drug. In 2012, the patient used leflunomide, her condition worsened; joint pain progressed; new joints were involved into the process, and cutaneous manifestations were aggravated. To verify a diagnosis and to choose therapy, the patient was referred to a consultation at the Moscow Research Institute of Rheumatology. Results. In connection with the high activity of the disease and with no response to the performed therapy, it was recommended to initiate therapy with biologics, such as infliximab, the drug of choice. Seven infliximab

Metabolic profile of clinically severe obese patients.

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Faria, Silvia Leite; Faria, Orlando Pereira; Menezes, Caroline Soares; de Gouvêa, Heloisa Rodrigues; de Almeida Cardeal, Mariane

2012-08-01

Since low basal metabolic rate (BMR) is a risk factor for weight regain, it is important to measure BMR before bariatric surgery. We aimed to evaluate the BMR among clinically severe obese patients preoperatively. We compared it with that of the control group, with predictive formulas and correlated it with body composition. We used indirect calorimetry (IC) to collect BMR data and multifrequency bioelectrical impedance to collect body composition data. Our sample population consisted of 193 patients of whom 130 were clinically severe obese and 63 were normal/overweight individuals. BMR results were compared with the following predictive formulas: Harris-Benedict (HBE), Bobbioni-Harsch (BH), Cunningham (CUN), Mifflin-St. Jeor (MSJE), and Horie-Waitzberg & Gonzalez (HW & G). This study was approved by the Ethics Committee for Research of the University of Brasilia. Statistical analysis was used to compare and correlate variables. Clinically severe obese patients had higher absolute BMR values and lower adjusted BMR values (p BMR were found in both groups. Among the clinically severe obese patients, the formulas of HW & G and HBE overestimated BMR values (p = 0.0002 and p = 0.0193, respectively), while the BH and CUN underestimated this value; only the MSJE formulas showed similar results to those of IC. The clinically severe obese patients showed low BMR levels when adjusted per kilogram per body weight. Body composition may influence BMR. The use of the MSJE formula may be helpful in those cases where it is impossible to use IC.

A National Strategy to Develop Pragmatic Clinical Trials Infrastructure

Science.gov (United States)

Guise, Jeanne‐Marie; Dolor, Rowena J.; Meissner, Paul; Tunis, Sean; Krishnan, Jerry A.; Pace, Wilson D.; Saltz, Joel; Hersh, William R.; Michener, Lloyd; Carey, Timothy S.

2014-01-01

Abstract An important challenge in comparative effectiveness research is the lack of infrastructure to support pragmatic clinical trials, which compare interventions in usual practice settings and subjects. These trials present challenges that differ from those of classical efficacy trials, which are conducted under ideal circumstances, in patients selected for their suitability, and with highly controlled protocols. In 2012, we launched a 1‐year learning network to identify high‐priority pragmatic clinical trials and to deploy research infrastructure through the NIH Clinical and Translational Science Awards Consortium that could be used to launch and sustain them. The network and infrastructure were initiated as a learning ground and shared resource for investigators and communities interested in developing pragmatic clinical trials. We followed a three‐stage process of developing the network, prioritizing proposed trials, and implementing learning exercises that culminated in a 1‐day network meeting at the end of the year. The year‐long project resulted in five recommendations related to developing the network, enhancing community engagement, addressing regulatory challenges, advancing information technology, and developing research methods. The recommendations can be implemented within 24 months and are designed to lead toward a sustained national infrastructure for pragmatic trials. PMID:24472114

PATIENT SATISFACTION AND DIETARY OUTCOMES FROM ATTENDING A MULTIDISCIPLINARY CYSTINURIA CLINIC

Directory of Open Access Journals (Sweden)

Angela Doherty

2012-06-01

Patients had varying degrees of success with making changes to each dietary parameter. Multi-source diet analysis allowed us to develop tailored consultations. All patients made some positive dietary changes which may help prevent stone formation. The areas of least change were fluid (due to changes made prior to clinic attendance and vegetable protein. Our results support the need for continued dietetic input. These results should be re-audited to check that patients are maintaining the changes made.

Effects of treatment adherence on clinical and economic outcomes in patients with psoriasis.

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Jevtić, Tatjana; Bukumirić, Zoran; Janković, Slobodan M

2013-02-01

To compare clinical and cost outcomes of psoriasis in non-biological treatment of adherent and non-adherent patients in a developing Balkans country going through socio-economic transition. The study was designed as a retrospective cohort study involving patients with psoriasis adherent and non-adherent to the prescribed treatment regimen. The patients were followed for a period of one year, through four visits with intervals of three months. The adherence to the prescribed regimen was measured at the end of the follow-up period by the medication possession ratio. Clinical outcomes of the treatment were estimated by the Psoriasis Area Severity Index (PASI) at each visit and the treatment costs were collected from patients' files at each visit. The study enrolled 108 patients, 61 (56.5%) were adherent to the prescribed treatment, and 47 (43.5%) were non-adherent. A signiicant decrease of PASI score was noted in the patients adherent to prescribed therapy (p drop of costs was the highest from the visit 3. The decrease in PASI score and costs were less rapid in non-adherent patients. Better treatment adherence leads to faster clinical improvement and a more rapid decrease in costs of treatment, which diminish overall expenditure of the health system and society, leaving room for treatment of other diseases more efficiently. Therefore, health systems of developing countries should support additional research of causes of treatment non-adherence in patients with psoriasis, in order to minimize this fenomenon more efficiently, and make significant savings.

Clinical potential for imaging in patients with asthma and other lung disorders.

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DeBoer, Emily M; Spielberg, David R; Brody, Alan S

2017-01-01

The ability of lung imaging to phenotype patients, determine prognosis, and predict response to treatment is expanding in clinical and translational research. The purpose of this perspective is to describe current imaging modalities that might be useful clinical tools in patients with asthma and other lung disorders and to explore some of the new developments in imaging modalities of the lung. These imaging modalities include chest radiography, computed tomography, lung magnetic resonance imaging, electrical impedance tomography, bronchoscopy, and others. Copyright © 2016 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.

Clinical characteristics of 138 Chinese female patients with idiopathic hypogonadotropic hypogonadism

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Rui-yi Tang

2017-11-01

Full Text Available Objective: To evaluate the clinical features of Chinese women with idiopathic hypogonadotropic hypogonadism (IHH. Methods: We retrospectively reviewed the clinical characteristics, laboratory and imaging findings, therapeutic management and fertility outcomes of 138 women with IHH. All patients had been treated and followed up at an academic medical centre during 1990–2016. Results: Among the 138 patients, 82 patients (59.4% were diagnosed with normosmic IHH and 56 patients (40.6% were diagnosed with Kallmann syndrome (KS. The patients with IHH experienced occasional menses (4.3%, spontaneous thelarche (45.7% or spontaneous pubarche (50.7%. Women with thelarche had a higher percentage of pubarche (P < 0.001 and higher gonadotropin concentrations (P < 0.01. Olfactory bulb/sulci abnormalities were found during the magnetic resonance imaging (MRI of all patients with KS. Most patients with IHH had osteopenia and low bone age. Among the 16 women who received gonadotropin-releasing hormone treatment, ovulation induction or assisted reproductive technology, the clinical pregnancy rate was 81.3% and the live birth rate was 68.8%. Conclusions: The present study revealed that the phenotypic spectrum of women with IHH is broader than typical primary amenorrhoea with no secondary sexual development, including occasional menses, spontaneous thelarche or pubarche. MRI of the olfactory system can facilitate the diagnosis of KS. Pregnancy can be achieved after receiving appropriate treatment.

A clinical return-to-work rule for patients with back pain.

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Dionne, Clermont E; Bourbonnais, Renée; Frémont, Pierre; Rossignol, Michel; Stock, Susan R; Larocque, Isabelle

2005-06-07

Tools for early identification of workers with back pain who are at high risk of adverse occupational outcome would help concentrate clinical attention on the patients who need it most, while helping reduce unnecessary interventions (and costs) among the others. This study was conducted to develop and validate clinical rules to predict the 2-year work disability status of people consulting for nonspecific back pain in primary care settings. This was a 2-year prospective cohort study conducted in 7 primary care settings in the Quebec City area. The study enrolled 1007 workers (participation, 68.4% of potential participants expected to be eligible) aged 18-64 years who consulted for nonspecific back pain associated with at least 1 day's absence from work. The majority (86%) completed 5 telephone interviews documenting a large array of variables. Clinical information was abstracted from the medical files. The outcome measure was "return to work in good health" at 2 years, a variable that combined patients' occupational status, functional limitations and recurrences of work absence. Predictive models of 2-year outcome were developed with a recursive partitioning approach on a 40% random sample of our study subjects, then validated on the rest. The best predictive model included 7 baseline variables (patient's recovery expectations, radiating pain, previous back surgery, pain intensity, frequent change of position because of back pain, irritability and bad temper, and difficulty sleeping) and was particularly efficient at identifying patients with no adverse occupational outcome (negative predictive value 78%- 94%). A clinical prediction rule accurately identified a large proportion of workers with back pain consulting in a primary care setting who were at a low risk of an adverse occupational outcome.

Placing wireless tablets in clinical settings for patient education.

Science.gov (United States)

Stribling, Judy C; Richardson, Joshua E

2016-04-01

The authors explored the feasibility and possible benefit of tablet-based educational materials for patients in clinic waiting areas. We distributed eight tablets preloaded with diagnosis-relevant information in two clinic waiting areas. Patients were surveyed about satisfaction, usability, and effects on learning. Technical issues were resolved. Thirty-seven of forty patients completed the survey. On average, the patients were satisfied in all categories. Placing tablet-based educational materials in clinic waiting areas is relatively easy to implement. Patients using tablets reported satisfaction across three domains: usability, education, and satisfaction.

Electronic medical records in humanitarian emergencies – the development of an Ebola clinical information and patient management system [version 3; referees: 2 approved

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Kiran Jobanputra

2017-02-01

Full Text Available By November 2015, the West Africa Ebola epidemic had caused 28598 infections and 11299 deaths in the three countries most affected. The outbreak required rapid innovation and adaptation. Médecins sans Frontières (MSF scaled up its usual 20-30 bed Ebola management centres (EMCs to 100-300 beds with over 300 workers in some settings. This brought challenges in patient and clinical data management resulting from the difficulties of working safely with high numbers of Ebola patients. We describe a project MSF established with software developers and the Google Social Impact Team to develop context-adapted tools to address the challenges of recording Ebola clinical information. We share the outcomes and key lessons learned in innovating rapidly under pressure in difficult environmental conditions. Information on adoption, maintenance, and data quality was gathered through review of project documentation, discussions with field staff and key project stakeholders, and analysis of tablet data. In March 2015, a full prototype was deployed in Magburaka EMC, Sierra Leone. Inpatient data were captured on 204 clinical interactions with 34 patients from 5 March until 10 April 2015. Data continued to also be recorded on paper charts, creating theoretically identical record “pairs” on paper and tablet. 83 record pairs for 33 patients with 22 data items (temperature and symptoms per pair were analysed. The overall Kappa coefficient for agreement between sources was 0.62, but reduced to 0.59 when rare bleeding symptoms were excluded, indicating moderate to good agreement. The time taken to deliver the product was more than that anticipated by MSF (7 months versus 6 weeks. Deployment of the tablet coincided with a dramatic drop in patient numbers and thus had little impact on patient care. We have identified lessons specific to humanitarian-technology collaborative projects and propose a framework for emergency humanitarian innovation. Time and effort is

Clinical and pathogenetic approaches to development of parodontitis therapy in patients with chronic hepatitis С

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E.N. Blinnikova

2010-06-01

Full Text Available The research goal in to determine clinical and pathogenetic efficacy of Cycloferon liniment in the combined therapy of parodontitis in patients with chronic hepatitis C. Examination and treatment of 50 patients were conducted. It was revealed that the use of Cycloferon liniment in the combined treatment of patients with parodontitis accompanied by chronic hepatitis C allowed to accelerate process of normalization of lipid peroxidation and antioxidant potential of blood, to decrease infectious inflammation (herpes simplex virus I, candida albicans, staphylococcus aureus in parodontal recess and local inflammation. The described method of treatment provided process of recovery and decrease in frequency of parodontitis recurrences

A descriptive survey investigating pre-registration student nurses' perceptions of clinical skill development in clinical placements.

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Stayt, Louise C; Merriman, Clair

2013-04-01

Clinical skill development is essential to nurse education. Clinical skills are frequently taught in higher education institutions using clinical simulation. It is unclear if clinical skills are subsequently consolidated and developed in clinical placements. The aim of this survey was to evaluate pre-registration student nurses perceptions of the frequency of opportunities to practise, the level of supervision and assessment of, clinical skills in their clinical placements. This was a cross-sectional survey design using an online, self-report questionnaire including a Likert-type scale and open ended comments. Four hundred and twenty one students, from all year groups, from a university in the south of England on a wide variety of clinical placements participated. Participants evaluated the frequency of opportunity to practise, level of supervision and assessment of and feedback on performance of specific clinical skills. Clinical skills evaluated were measurement of vital signs, aseptic non-touch technique, assisting with eating and drinking, and assisting with comfort and hygiene. Data were analysed utilising Statistical Package for the Social Sciences Version 19. The frequency of opportunities to practise skills in clinical placement was variable with some participants reporting that they never had opportunity to practise essential skills. Similarly the level of supervision and assessment was also inconsistent suggesting that participants frequently practised clinical skills unsupervised without being assessed as competent. Inconsistencies in clinical skill development may lead to graduates who are not work ready and as a result, insufficient clinical competence potentially leads to unsafe practice and poor patient care. This calls for stronger partnerships between educators and clinical areas and the prioritisation of mentor preparation and education as well as organisational support in terms of mentor workload planning. Copyright © 2012 Elsevier Ltd. All

Patient safety trilogy: perspectives from clinical engineering.

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Gieras, Izabella; Sherman, Paul; Minsent, Dennis

2013-01-01

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

College clinic service quality and patient satisfaction.

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Deshwal, Pankaj; Ranjan, Vini; Mittal, Geetika

2014-01-01

The purpose of this paper is to identify the service quality dimensions that play an important role in patient satisfaction in campus clinics in Delhi; assess student satisfaction with service; and suggests ways to improve areas of dissatisfaction. A questionnaire was distributed to students who had completed at least two consultations at the college clinic. Convenience sampling was used to approach respondents. The questionnaire uses modified SERVQUAL and other instruments, including original dimensions and those constructed through detailed discussions. Factor analyses, reliability tests and the Kaiser-Meyer-Olkin measure of sampling adequacy were conducted. The final sample had a total of 445 respondents. After factor analysis, the authors found that the dimensions affecting patient satisfaction are: staff professionalism; clinic staff reliability; clinic accessibility and basic facilities; tangibles; cleanliness; awareness of the clinic/diseases and how clinic staff deals with emergencies. Most students were satisfied with the professionalism of the clinic staff. More than 70 percent of the respondents reported that the clinic staff paid good attention to them. The campus clinic was deemed reliable by more than 50 percent of respondents. The students found the clinic's location convenient, with more than 50 percent supporting its location. However, there was dissatisfaction among the students regarding the tangibles of the clinic, with more than 50 percent favoring upgrading. There was satisfaction among the respondents regarding the availability of the doctor after clinic hours, but contact details for the clinic staff were not easily accessible on campus. More than 60 percent of respondents were satisfied with the cleanliness of the campus clinic. More than 50 percent felt that the campus clinic was not equipped to deal with emergencies efficiently. At the same time, 90 percent of respondents reported the availability of referral facilities in case of

Development and validation of a patient-reported outcome measure for stroke patients.

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Luo, Yanhong; Yang, Jie; Zhang, Yanbo

2015-05-08

Family support and patient satisfaction with treatment are crucial for aiding in the recovery from stroke. However, current validated stroke-specific questionnaires may not adequately capture the impact of these two variables on patients undergoing clinical trials of new drugs. Therefore, the aim of this study was to develop and evaluate a new stroke patient-reported outcome measure (Stroke-PROM) instrument for capturing more comprehensive effects of stroke on patients participating in clinical trials of new drugs. A conceptual framework and a pool of items for the preliminary Stroke-PROM were generated by consulting the relevant literature and other questionnaires created in China and other countries, and interviewing 20 patients and 4 experts to ensure that all germane parameters were included. During the first item-selection phase, classical test theory and item response theory were applied to an initial scale completed by 133 patients with stroke. During the item-revaluation phase, classical test theory and item response theory were used again, this time with 475 patients with stroke and 104 healthy participants. During the scale assessment phase, confirmatory factor analysis was applied to the final scale of the Stroke-PROM using the same study population as in the second item-selection phase. Reliability, validity, responsiveness and feasibility of the final scale were tested. The final scale of Stroke-PROM contained 46 items describing four domains (physiology, psychology, society and treatment). These four domains were subdivided into 10 subdomains. Cronbach's α coefficients for the four domains ranged from 0.861 to 0.908. Confirmatory factor analysis supported the validity of the final scale, and the model fit index satisfied the criterion. Differences in the Stroke-PROM mean scores were significant between patients with stroke and healthy participants in nine subdomains (P < 0.001), indicating that the scale showed good responsiveness. The Stroke

Clinical Practicability of a Newly Developed Real-time Digital Kymographic System.

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Lee, Jin-Choon; Wang, Soo-Geun; Sung, Eui-Suk; Bae, In-Ho; Kim, Seong-Tae; Lee, Yeon-Woo

2017-12-22

A digital kymogram shows real images of vocal fold vibration. However, DKG is difficult to use in clinical practice because the recorded image cannot be seen instantaneously after examination, as considerable encoding time is required to visualize a digital kymogram. In addition, frame-by frame analysis should be implemented to evaluate high-speed videoendoscopy data, but is time- and labor-intensive. The purpose of the study was to validate the clinical practicability of a real-time multislice digital kymographic system developed by the authors. We analyzed the promptness and accuracy of the examination before and after intracordal injections in patients with unilateral vocal fold paralysis. To assess the clinical applicability of this system, six patients with unilateral vocal fold paralysis were selected. Real-time DKG was performed before and immediately after intracordal injection. We observed changes in the digital kymogram after the intracordal injection. Using this system, 10 scanning lines and up to five vertical pixel row could be obtained in real time, and the maximum acquisition time for the DKG image was 10 seconds. A digital kymogram of the patients could be instantaneously acquired, and whether the intracordal injection was appropriate or not. This article is the first validation study after the development of the real-time multislice digital kymographic system. Our system may be a promising tool in clinical practice for immediate assessment of the vibratory patterns of the vocal cords. More research is necessary for further clinical validation. Copyright © 2017 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

Development and Implementation of the Clinical Decision Support System for Patients With Cancer and Nurses' Experiences Regarding the System.

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Yılmaz, Arzu Akman; Ozdemir, Leyla

2017-01-01

The purpose of this study was to develop and implement the clinical decision support system (CDSS) for oncology nurses in the care of patients with cancer and to explore the nurses' experiences about the system. The study was conducted using a mixed-methods research design with 14 nurses working at a gynecological oncology clinic at a university hospital in Turkey. The nurses stated that they did not experience any problems during the implementation of the CDSS, and its usage facilitated the assessment of patients' needs and care management. The results indicated that the CDSS supported the nurses' decision-making process about patients' needs and preparation of individual care plans. The CDSS should be developed and implemented by the nurses working with patients with cancer. AMAÇ: Amaç kanser hastalarının bakımına yönelik klinik karar destek sistemi oluşturmak, uygulamak (KKDS) ve sistemi kullanan hemşirelerin deneyimlerini incelemektir. YÖNTEM: Çalışma kalitatif ve kantitatif araştırma yöntemleri kullanılarak Türkiyede'ki bir üniversite hastanesinin jinekolojik onkoloji servisinde çalışan 14 hemşire ile yürütülmüştür. Hemşireler KKDS'ni kullanırken herhangi bir sorun yaşamadıklarını ve sistemin hasta gereksinimlerini değerlendirmeyi ve bakım yönetimini kolaylaştırdığını belirtmişlerdir. SONUÇ: Bulgular hastanın gereksinimlerine karar verme sürecinde ve bireysel bakım planları hazırlamada KKDS'nin hemşireleri desteklediğini göstermektedir. HEMŞIRELIK UYGULAMALARI IÇIN ÖNERILER: Kanserli hastaların bakımına yönelik KKDS geliştirilebilir ve hemşireler tarafından klinikte kullanılabilir. © 2015 NANDA International, Inc.

Developing an appropriate staff mix for anticoagulation clinics: functional job analysis approach

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Hailemariam, Desta A.; Shan, Xiaojun; Chung, Sung H.; Khasawneh, Mohammad T.; Lukesh, William; Park, Angela; Rose, Adam

2018-05-01

Anticoagulation clinics (ACCs) are specialty clinics that manage patients with blood clotting problems. Since labor costs usually account for a substantial portion of a healthcare organization's budget, optimizing the number and types of staff required was often the focus, especially for ACCs, where labor-intensive staff-patient interactions occur. A significant portion of tasks performed by clinical pharmacists might be completed by clinical pharmacist technicians, which are less-expensive resources. While nurse staffing models for a hospital inpatient unit are well established, these models are not readily applicable to staffing ACCs. Therefore, the objective of this paper is to develop a framework for determining the right staff mix of clinical pharmacists and clinical pharmacy technicians that increases the efficiency of care delivery process and improves the productivity of ACC staff. A framework is developed and applied to build a semi-automated full-time equivalent (FTE) calculator and compare various staffing scenarios using a simulation model. The FTE calculator provides the right staff mix for a given staff utilization target. Data collected from the ACCs at VA Boston Healthcare System is used to illustrate the FTE calculator and the simulation model. The result of the simulation model can be used by ACC managers to easily determine the number of FTEs of clinical pharmacists and clinical pharmacy technicians required to reach the target utilization and the corresponding staffing cost.

The impact of sub-clinical over-hydration on left ventricular mass in peritoneal dialysis patients.

Science.gov (United States)

Hassan, Kamal; Hassan, Dunia; Shturman, Alexander; Rubinchik, Irina; Fadi, Hassan; Shadi, Hassan; Atar, Shaul

2015-01-01

Left ventricular hypertrophy (LVH) represents a major predictor of the development of cardiovascular (CV) complications. Over-hydration (OH) is an important uremic risk factor associated with LVH and increased CV morbidity and mortality in peritoneal dialysis (PD) patients. In the present study we evaluated the prevalence of sub-clinical OH (SCOH) among PD patients and its effects on left ventricular mass (LVM). In this cross sectional study hydration status, blood pressure, glucose load, systemic inflammation and LVM were evaluated in 43 clinically stable patients on maintenance PD for 24-76 months. The hydration status was assessed by whole-body bio-impedance spectroscopy (BIS). Peripheral edema and any evidence of pulmonary congestion were considered clinical signs of OH. OH ≥ 1.5 L was detected in 26 (60.5%) of the study participants; the OH in 19 (73.1%) of them was sub-clinical. Only 23.5% (4/17) of patients with OH < 1.5 L had LVH compared to 68.4% (13/19) of those with SCOH ≥ 1.5 L (P = 0.007). Compared to patients with OH < 1.5 L, patients with SCOH ≥ 1.5 L had higher levels of blood pressure, peritoneal glucose load, plasma brain natriuretic peptide, high sensitive C-reactive protein, interleukin-6 and LVMI; and lower levels of serum albumin (P < 0.001). No significant differences were found between patients with clinical OH or SCOH with OH ≥ 1.5 L. SCOH is highly prevalent among PD patients and may contribute to the development of LVH. Considering the poor prognosis associated with over-hydrated PD patients, periodic assessment of hydration status using accurate BIS is suggested.

Lessons Learned from Developing a Patient Engagement Panel: An OCHIN Report.

Science.gov (United States)

Arkind, Jill; Likumahuwa-Ackman, Sonja; Warren, Nate; Dickerson, Kay; Robbins, Lynn; Norman, Kathy; DeVoe, Jennifer E

2015-01-01

There is renewed interest in patient engagement in clinical and research settings, creating a need for documenting and publishing lessons learned from efforts to meaningfully engage patients. This article describes early lessons learned from the development of OCHIN's Patient Engagement Panel (PEP). OCHIN supports a national network of more than 300 community health centers (CHCs) and other primary care settings that serve over 1.5 million patients annually across nearly 20 states. The PEP was conceived in 2009 to harness the CHC tradition of patient engagement in this new era of patient-centered outcomes research and to ensure that patients were engaged throughout the life cycle of our research projects, from conception to dissemination. Developed by clinicians and researchers within our practice-based research network, recruitment of patients to serve as PEP members began in early 2012. The PEP currently has a membership of 18 patients from 3 states. Over the past 24 months, the PEP has been involved with 12 projects. We describe developing the PEP and challenges and lessons learned (eg, recruitment, funding model, creating value for patient partners, compensation). These lessons learned are relevant not only for research but also for patient engagement in quality improvement efforts and other clinical initiatives. © Copyright 2015 by the American Board of Family Medicine.

Impact of Facilitated Asynchronous Distance Education on Clinical Skills Development of International Pharmacy Graduates

Science.gov (United States)

Austin, Zubin; Dean, Marie Rocchi

2006-01-01

The use of distance education for clinical skills development in the health professions has not been extensively described, due in part to the intensive nature of the relationship between the patient and practitioner. In the context of pharmacy practice, there are specific needs to develop new vehicles for clinical skills education due to growing…

Placing wireless tablets in clinical settings for patient education

Directory of Open Access Journals (Sweden)

Judy C. Stribling, MA, MLS

2016-11-01

Full Text Available Objective: The authors explored the feasibility and possible benefit of tablet-based educational materials for patients in clinic waiting areas. Methods: We distributed eight tablets preloaded with diagnosis-relevant information in two clinic waiting areas. Patients were surveyed about satisfaction, usability, and effects on learning. Technical issues were resolved. Results: Thirty-seven of forty patients completed the survey. On average, the patients were satisfied in all categories. Conclusions: Placing tablet-based educational materials in clinic waiting areas is relatively easy to implement. Patients using tablets reported satisfaction across three domains: usability, education, and satisfaction.

Experiences with developing and implementing a virtual clinic for glaucoma care in an NHS setting.

Science.gov (United States)

Kotecha, Aachal; Baldwin, Alex; Brookes, John; Foster, Paul J

2015-01-01

This article describes the development of a virtual glaucoma clinic, whereby technicians collect information for remote review by a consultant specialist. This was a hospital-based service evaluation study. Patients suitable for the stable monitoring service (SMS) were low-risk patients with "suspect", "early"-to-"moderate" glaucoma who were deemed stable by their consultant care team. Three technicians and one health care assistant ran the service. Patients underwent tests in a streamlined manner in a dedicated clinical facility, with virtual review of data by a consultant specialist through an electronic patient record. Feasibility of developing a novel service within a UK National Health Service setting and improvement of patient journey time within the service were studied. Challenges to implementation of virtual clinic include staffing issues and use of information technology. Patient journey time within the SMS averaged 51 minutes, compared with 92 minutes in the glaucoma outpatient department. Patient satisfaction with the new service was high. Implementing innovation into existing services of the National Health Service is challenging. However, the virtual clinic showed an improved patient journey time compared with that experienced within the general glaucoma outpatient department. There exists a discrepancy between patient management decisions of reviewers, suggesting that some may be more risk averse than others when managing patients seen within this model. Future work will assess the ability to detect progression of disease in this model compared with the general outpatient model of care.

A survey of patients' attitudes to clinical research.

LENUS (Irish Health Repository)

Desmond, A

2011-04-01

Every year hundreds of patients voluntarily participate in clinical trials across Ireland. However, little research has been done as to how patients find the experience. This survey was conducted in an attempt to ascertain clinical trial participants\\' views on their experience of participating in a clinical trial and to see and how clinical trial participation can be improved. One hundred and sixty-six clinical trial participants who had recently completed a global phase IV cardiovascular endpoint clinical trial were sent a 3-page questionnaire. Ninety-one (91%) respondents found the experience of participating in a clinical trial a good one with 85 (84.16%) respondents saying they would recommend participating in a clinical trial to a friend or relative and eighty-five (87.63%) respondents feeling they received better healthcare because they had participated in a clinical trial.

Clinical characterization of patients with macroprolactinemia and monomeric hyperprolactinemia

Directory of Open Access Journals (Sweden)

Murat Can

2011-05-01

Full Text Available Macroprolactinemia is often a cause of misdiagnosis, unnecessary expensive investigation, and unsuitable treatment. The aim of the present study was to investigate the clinical findings and the concentrations of macroprolactin in patients with hyperprolactinemia in our region. Eighty-four female hyperprolactinemic patients were screened for macroprolactinemia. Prolactin was measured by chemiluminesans method on an Immulite 2000 analyzer (Siemens Health Diagnostics, Deerfield, IL, USA. Recoveries less than or equal to 40% after polyethylene glycol precipitation were indicative of macroprolactinemia. Clinical features and biochemical values were compared in true hyperprolactinemic and macroprolactinemic patients. Macroprolactinemia was detected in 31 patients (36.9%, with 84 hyperprolactinemic female patients. There was no difference in frequency of galactorrhea and oligomenorrhea/amenorrhea between the two groups. When we evaluated the clinical features of patients according to prolactin levels, no significant difference was found between the groups. In conclusion, our initial data show that no clinical features could reliably differentiate macroprolactinemic from true hyperprolactinemic patients, but at least one of these symptoms was present in most macroprolactinemic patients.

Clinical evaluation of 413 Thalassemic patients

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Korosdari Gh.H

2000-08-01

Full Text Available Thalassemia is the most prevalent genetic disorder in Iran and around the world and these patients need regular careful care. The present study reports results of routine examination of patients visited Thalassemia clinic of Tehran. Data about clinical and laboratory examinations of 413 Thalassemic were extracted and analyzed. The prevalence of heart complications, diabetes, growth retardation, delayed puberty and primary and secondary amenorrhea was 9%, 8%, 21.3%, 3.1% and 6.3%, respectively. 44% didn't have secondary sex characteristics. Splenectomy had been done for 67.2% of cases. HBsAg, HBsAb and HBcAb were positive in 1.9%, 57.4% and 43%, respectively. We concluded that blood transfusion standards in this clinic was acceptable, whereas because of poor knowledge, iron chelating is unfavorable.

Development of a Primary Care-Based Clinic to Support Adults With a History of Childhood Cancer: The Tactic Clinic.

Science.gov (United States)

Overholser, Linda S; Moss, Kerry M; Kilbourn, Kristin; Risendal, Betsy; Jones, Alison F; Greffe, Brian S; Garrington, Timothy; Leonardi-Warren, Kristin; Yamashita, Traci E; Kutner, Jean S

2015-01-01

Describe the development and evolution of a primary-care-based, multidisciplinary clinic to support the ongoing care of adult survivors of childhood cancer. A consultative clinic for adult survivors of childhood cancer has been developed that is located in an adult, academic internal medicine setting and is based on a long-term follow-up clinic model available at Children's Hospital Colorado. The clinic opened in July 2008. One hundred thirty-five patients have been seen as of April 2014. Referrals and clinic capacity have gradually increased over time, and a template has been developed in the electronic medical record to help facilitate completion of individualized care plan letters. A primary care-based, multidisciplinary consultative clinic for adults with a history of childhood cancer survivor is feasible and actively engages adult primary care resources to provide risk-based care for long-term pediatric cancer survivors. This model of care planning can help support adult survivors of pediatric cancer and their primary care providers in non-academic, community settings as well. Copyright © 2015 Elsevier Inc. All rights reserved.

Cardiac management of oncology patients clinical handbook for cardio-oncology

CERN Document Server

Baron Esquivias, Gonzalo

2015-01-01

This book is designed for clinical cardiologists and other physicians working with cardiac patients, where specific specialized teams of cardio-oncologists are not available and who are called to perform a clinical consultation to evaluate both the cardiac condition and the eligibility for chemotherapy or radiotherapy treatment, and to evaluate if a cancer treatment produces toxic effects on a patient treated with chemo or radiotherapy and if appearance of new symptoms is due to this treatment. In recent years, progress in oncologic therapy has resulted in important developments and the prognostic improvement of patients with malignancy. The cornerstone of chemotherapy are the anthracyclines (and the analogue Mitoxantrone), that are direct cellular toxic agents and that are among the most powerful anti-neoplastic drugs, but their cardiac toxicity is well known. Significant breakthroughs in cancer therapy have also been achieved with the introduction of signalling inhibitors, such as VEGF inhibitors, HERB2 inh...

Instrument development and evaluation for patient-related outcomes assessments

Directory of Open Access Journals (Sweden)

Farnik M

2012-03-01

Full Text Available Małgorzata Farnik, Władysław PierzchałaDepartment of Pneumonology, Silesian University of Medicine, Katowice, PolandAbstract: Patient-related outcomes measures could provide important information for the current state of the art in medical care and even have an impact on macrodecisions in the health care system. Patient-related outcomes were initially defined as subjective health indicators that allow disability and illness to be assessed, based on patient, caregiver, or physician self-reports. As illness involves psychological and behavioral complex processes of care, a multidisciplinary approach in measuring patient-reported outcomes should be recommended, such as quality of life questionnaires. Patient-related outcomes measures should correspond to specific clinical situations and bring opportunities to improve quality of care. Objective measurements enable quantitative data to be collected and analyzed. Depending on the aim of the research, investigators can use existing methods or develop new tools. This publication presents a methodology for developing patient-related outcomes measures, based on a multistage procedure. The proper definition of specific study objectives and the methodology of instrument development are crucial for successfully transferring the study concept. The model of instrument development is the process of starting from the preliminary phase and includes questionnaire design and scaling, pilot testing (cognitive debriefing, revision of the preliminary version, evaluation of the new tool, and implementation. Validation of the new instrument includes reliability, reproducibility, internal consistency, and responsiveness. The process of designing the new tool should involve a panel of experts, including clinicians, psychologists (preliminary phase, and statisticians (scale development and scoring, and patients (cognitive debriefing. Implementation of a new tool should be followed by evaluation study – assessment of

Clinical outcomes in hypertensive or diabetes patients who ...

African Journals Online (AJOL)

Background: The use of complementary medicines in addition to medical prescription by patients with hypertension, diabetes and other chronic diseases presents a challenge for healthcare providers in Nigeria and globally. There is very little data on the clinical outcomes in these patients. Objectives: To evaluate clinical ...

Mathematical modeling of efficacy and safety for anticancer drugs clinical development.

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Lavezzi, Silvia Maria; Borella, Elisa; Carrara, Letizia; De Nicolao, Giuseppe; Magni, Paolo; Poggesi, Italo

2018-01-01

Drug attrition in oncology clinical development is higher than in other therapeutic areas. In this context, pharmacometric modeling represents a useful tool to explore drug efficacy in earlier phases of clinical development, anticipating overall survival using quantitative model-based metrics. Furthermore, modeling approaches can be used to characterize earlier the safety and tolerability profile of drug candidates, and, thus, the risk-benefit ratio and the therapeutic index, supporting the design of optimal treatment regimens and accelerating the whole process of clinical drug development. Areas covered: Herein, the most relevant mathematical models used in clinical anticancer drug development during the last decade are described. Less recent models were considered in the review if they represent a standard for the analysis of certain types of efficacy or safety measures. Expert opinion: Several mathematical models have been proposed to predict overall survival from earlier endpoints and validate their surrogacy in demonstrating drug efficacy in place of overall survival. An increasing number of mathematical models have also been developed to describe the safety findings. Modeling has been extensively used in anticancer drug development to individualize dosing strategies based on patient characteristics, and design optimal dosing regimens balancing efficacy and safety.

Improving patient access to an interventional US clinic.

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Steele, Joseph R; Clarke, Ryan K; Terrell, John A; Brightmon, Tonya R

2014-01-01

A continuous quality improvement project was conducted to increase patient access to a neurointerventional ultrasonography (US) clinic. The clinic was experiencing major scheduling delays because of an increasing patient volume. A multidisciplinary team was formed that included schedulers, medical assistants, nurses, technologists, and physicians. The team created an Ishikawa diagram of the possible causes of the long wait time to the next available appointment and developed a flowchart of the steps involved in scheduling and completing a diagnostic US examination and biopsy. The team then implemented a staged intervention that included adjustments to staffing and room use (stage 1); new procedures for scheduling same-day add-on appointments (stage 2); and a lead technician rotation to optimize patient flow, staffing, and workflow (stage 3). Six months after initiation of the intervention, the mean time to the next available appointment had decreased from 25 days at baseline to 1 day, and the number of available daily appointments had increased from 38 to 55. These improvements resulted from a coordinated provider effort and had a net present value of more than $275,000. This project demonstrates that structural changes in staffing, workflow, and room use can substantially reduce scheduling delays for critical imaging procedures. © RSNA, 2014.

Clinical Complexity in Medicine: A Measurement Model of Task and Patient Complexity.

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Islam, R; Weir, C; Del Fiol, G

2016-01-01

Complexity in medicine needs to be reduced to simple components in a way that is comprehensible to researchers and clinicians. Few studies in the current literature propose a measurement model that addresses both task and patient complexity in medicine. The objective of this paper is to develop an integrated approach to understand and measure clinical complexity by incorporating both task and patient complexity components focusing on the infectious disease domain. The measurement model was adapted and modified for the healthcare domain. Three clinical infectious disease teams were observed, audio-recorded and transcribed. Each team included an infectious diseases expert, one infectious diseases fellow, one physician assistant and one pharmacy resident fellow. The transcripts were parsed and the authors independently coded complexity attributes. This baseline measurement model of clinical complexity was modified in an initial set of coding processes and further validated in a consensus-based iterative process that included several meetings and email discussions by three clinical experts from diverse backgrounds from the Department of Biomedical Informatics at the University of Utah. Inter-rater reliability was calculated using Cohen's kappa. The proposed clinical complexity model consists of two separate components. The first is a clinical task complexity model with 13 clinical complexity-contributing factors and 7 dimensions. The second is the patient complexity model with 11 complexity-contributing factors and 5 dimensions. The measurement model for complexity encompassing both task and patient complexity will be a valuable resource for future researchers and industry to measure and understand complexity in healthcare.

Clinical Profile and HIV/AIDS Prevalence of Patients with ...

African Journals Online (AJOL)

Background: Clinical features of HIV/AIDS and various malignancies are similar. Clinical profiles and HIV/AIDS prevalence in Nigerian cancer patients have been poorly documented. Aim: To identify the patterns of clinical presentations in patients with malignancies and to determine the prevalence of HIV infection in cancer ...

Development of reflective judgement in the pre-doctoral dental clinical curriculum.

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Boyd, L D

2008-08-01

When dental students begin patient care in the clinical curriculum, they are required to move from the well-defined problems of the classroom to the more ambiguous and real life problems encountered in the context of patient care in the clinical setting. This change in learning environment requires development of reflective thinking. Reflective thinking refers to the process of thinking about uncertainty or ill-defined problems. King and Kitchener refer to the outcome of the reflective thinking process as reflective judgement. The purpose of this study was to explore the development of reflective judgement in the initial phase of the clinical curriculum. This exploratory study used a case study approach with qualitative methods. A convenience sample of third year predoctoral dental students (n = 16) volunteered to participate in writing a clinic journal and semi-structured interviews at three time points over a time period of one year. Student compliance in writing clinical journals was poor; therefore the qualitative data was primarily gathered from interview transcripts. The qualitative interview data were analysed using a coding scheme based on King and Kitchener's Reflective Judgement Model of Intellectual Development. The Cronbach alpha was 0.76 for reliability of the coding scheme. Based on the analysis of interview data, the there was an average growth in reflective judgement over the year from Stage 4.89 to 5.59 for an overall change of +0.70. Additional research is needed to explore the growth in reflective judgement over the final year of the clinical curriculum as well as to identify the most effective educational strategies to facilitate growth in reflective judgment.

Suicide attempts and clinical features of bipolar patients

OpenAIRE

Berkol, Tongu? D.; ?slam, Serkan; K?rl?, Ebru; P?narba??, Rasim; ?zy?ld?r?m, ?lker

2016-01-01

Objectives: To identify clinical predictors of suicide attempts in patients with bipolar disorder. Methods: This study included bipolar patients who were treated in the Psychiatry Department, Haseki Training and Research Hospital, Istanbul, Turkey, between 2013 and 2014; an informed consent was obtained from the participants. Two hundred and eighteen bipolar patients were assessed by using the structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders, 4th edition...

Dissecting inflammatory complications in critically injured patients by within-patient gene expression changes: a longitudinal clinical genomics study.

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Keyur H Desai

2011-09-01

Full Text Available Trauma is the number one killer of individuals 1-44 y of age in the United States. The prognosis and treatment of inflammatory complications in critically injured patients continue to be challenging, with a history of failed clinical trials and poorly understood biology. New approaches are therefore needed to improve our ability to diagnose and treat this clinical condition.We conducted a large-scale study on 168 blunt-force trauma patients over 28 d, measuring ∼400 clinical variables and longitudinally profiling leukocyte gene expression with ∼800 microarrays. Marshall MOF (multiple organ failure clinical score trajectories were first utilized to organize the patients into five categories of increasingly poor outcomes. We then developed an analysis framework modeling early within-patient expression changes to produce a robust characterization of the genomic response to trauma. A quarter of the genome shows early expression changes associated with longer-term post-injury complications, captured by at least five dynamic co-expression modules of functionally related genes. In particular, early down-regulation of MHC-class II genes and up-regulation of p38 MAPK signaling pathway were found to strongly associate with longer-term post-injury complications, providing discrimination among patient outcomes from expression changes during the 40-80 h window post-injury.The genomic characterization provided here substantially expands the scope by which the molecular response to trauma may be characterized and understood. These results may be instrumental in furthering our understanding of the disease process and identifying potential targets for therapeutic intervention. Additionally, the quantitative approach we have introduced is potentially applicable to future genomics studies of rapidly progressing clinical conditions.ClinicalTrials.gov NCT00257231

Developing a pathway for high-value, patient-centered total joint arthroplasty.

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Van Citters, Aricca D; Fahlman, Cheryl; Goldmann, Donald A; Lieberman, Jay R; Koenig, Karl M; DiGioia, Anthony M; O'Donnell, Beth; Martin, John; Federico, Frank A; Bankowitz, Richard A; Nelson, Eugene C; Bozic, Kevin J

2014-05-01

Total joint arthroplasty (TJA) is one of the most widely performed elective procedures; however, there are wide variations in cost and quality among facilities where the procedure is performed. The purposes of this study were to (1) develop a generalizable clinical care pathway for primary TJA using inputs from clinical, academic, and patient stakeholders; and (2) identify system- and patient-level processes to provide safe, effective, efficient, and patient-centered care for patients undergoing TJA. We used a combination of quantitative and qualitative methods to design a care pathway that spans 14 months beginning with the presurgical office visit and concluding 12 months after discharge. We derived care suggestions from interviews with 16 hospitals selected based on readmission rates, cost, and quality (n = 10) and author opinion (n = 6). A 32-member multistakeholder panel refined the pathway during a 1-day workshop. Participants were selected based on leadership in orthopaedic (n = 4) and anesthesia (n = 1) specialty societies; involvement in organizations specializing in safety and high reliability care (n = 3), lean production/consumption of care (n = 3), and patient experience of care (n = 3); membership in an interdisciplinary care team of a hospital selected for interviewing (n = 8); recent receipt of a TJA (n = 1); and participation in the pathway development team (n = 9). The care pathway includes 40 suggested processes to improve care, 37 techniques to reduce waste, and 55 techniques to improve communication. Central themes include standardization and process improvement, interdisciplinary communication and collaboration, and patient/family engagement and education. Selected recommendations include standardizing care protocols and staff roles; aligning information flow with patient and process flow; identifying a role accountable for care delivery and communication; managing patient expectations; and stratifying patients into the most appropriate care

Clinical profile and mutation analysis of xeroderma pigmentosum in Indian patients.

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Tamhankar, Parag M; Iyer, Shruti V; Ravindran, Shyla; Gupta, Neerja; Kabra, Madhulika; Nayak, Chitra; Kura, Mahendra; Sanghavi, Swapnil; Joshi, Rajesh; Chennuri, Vasundhara Sridhar; Khopkar, Uday

2015-01-01

Xeroderma pigmentosum (XP) is an autosomal recessive genetic disorder characterized by cutaneous and ocular photosensitivity and an increased risk of developing cutaneous neoplasms. Progressive neurological abnormalities develop in a quarter of XP patients. To study the clinical profile and perform a mutation analysis in Indian patients with xeroderma pigmentosum. Ten families with 13 patients with XP were referred to our clinic over 2 years. The genes XPA, XPB and XPC were sequentially analyzed till a pathogenic mutation was identified. Homozygous mutations in the XPA gene were seen in patients with moderate to severe mental retardation (6/10 families) but not in those without neurological features. Two unrelated families with a common family name and belonging to the same community from Maharashtra were found to have an identical mutation in the XPA gene, namely c.335_338delTTATinsCATAAGAAA (p.F112SfsX2). Testing of the XPC gene in two families with four affected children led to the identification of the novel mutations c.1243C>T or p.R415X and c.1677C>A or p.Y559X. In two families, mutations could not be identified in XPA, XPB and XPC genes. The sample size is small. Indian patients who have neurological abnormalities associated with XP should be screened for mutations in the XPA gene.

A Method for Developing Standard Patient Education Program.

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Lura, Carolina Bryne; Hauch, Sophie Misser Pallesgaard; Gøeg, Kirstine Rosenbeck; Pape-Haugaard, Louise

2018-01-01

In Denmark, patients being treated on Haematology Outpatients Departments get instructed to self-manage their blood sample collection from Central Venous Catheter (CVC). However, this is a complex and risky procedure, which can jeopardize patient safety. The aim of the study was to suggest a method for developing standard digital patient education programs for patients in self-administration of blood samples drawn from CVC. The Design Science Research Paradigm was used to develop a digital patient education program, called PAVIOSY, to increase patient safety during execution of the blood sample collection procedure by using videos for teaching as well as procedural support. A step-by-step guide was developed and used as basis for making the videos. Quality assurance through evaluation with a nurse was conducted on both the step-by-step guide and the videos. The quality assurance evaluation of the videos showed; 1) Errors due to the order of the procedure can be determined by reviewing the videos despite that the guide was followed. 2) Videos can be used to identify errors - important for patient safety - in the procedure, which are not identifiable in a written script. To ensure correct clinical content of the educational patient system, health professionals must be engaged early in the development of content and design phase.

The role of fungal sensitisation in clinical presentation in patients with chronic obstructive pulmonary disease.

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Agarwal, Kshitij; Gaur, Shailendra Nath; Chowdhary, Anuradha

2015-09-01

Atopic patients with chronic obstructive pulmonary disease (COPD) demonstrate more severe symptoms than their non-atopic counterparts. Also, Aspergillus hypersensitivity is known in COPD. However, allergic sensitisation to non-Aspergillus fungi has never been studied in COPD patients. To evaluate the prevalence of fungal sensitisation and its impact on the clinical presentation and outcome of COPD patients. Sensitisation to 17 fungi was studied in 55 COPD patients through skin prick tests, fungus-specific IgE, precipitating antibodies, total IgE and eosinophil counts. The clinical symptoms of patients were monitored thorough a patient-administered questionnaire. Overall, 5.4% (n = 3) of COPD patients were fungus sensitive. The sensitisation was noted to Alternaria alternata and Schizophyllum commune in two patients each, whereas another was sensitive to A. tamarii, Rhizopus spp. and Aspergillus fumigatus. Eosinophils were higher in fungus-sensitised patients (P = 0.001 vs. 0.003). No differences were noted in the clinical presentation of patients sensitised to fungi compared to those not sensitised to fungi or non-atopic. Although low, fungal sensitisation occurs in COPD but it is not limited to Aspergilli alone. Fungus-sensitised patients exhibit greater eosinophilia, implying more severe inflammation. Thus, such patients should be followed up regularly to recognise clinical worsening or development of ABPM. © 2015 Blackwell Verlag GmbH.

The role of elective nodal irradiation for esthesioneuroblastoma patients with clinically negative neck.

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Jiang, Wen; Mohamed, Abdallah S R; Fuller, Clifton David; Kim, Betty Y S; Tang, Chad; Gunn, G Brandon; Hanna, Ehab Y; Frank, Steven J; Su, Shirley Y; Diaz, Eduardo; Kupferman, Michael E; Beadle, Beth M; Morrison, William H; Skinner, Heath; Lai, Stephen Y; El-Naggar, Adel K; DeMonte, Franco; Rosenthal, David I; Garden, Adam S; Phan, Jack

2016-01-01

Although adjuvant radiation to the tumor bed has been reported to improve the clinic outcomes of esthesioneuroblastoma (ENB) patients, the role of elective neck irradiation (ENI) in clinically node-negative (N0) patients remains controversial. Here, we evaluated the effects of ENI on neck nodal relapse risk in ENB patients treated with radiation therapy as a component of multimodality treatment. Seventy-one N0 ENB patients irradiated at the University of Texas MD Anderson Cancer Center between 1970 and 2013 were identified. ENI was performed on 22 of these patients (31%). Survival analysis was performed with focus on comparative outcomes of those patients who did and did not receive ENI. The median follow-up time for our cohort is 80.8 months (range, 6-350 months). Among N0 patients, 13 (18.3%) developed neck nodal relapses, with a median time to progression of 62.5 months. None of these 13 patients received prophylactic neck irradiation. ENI was associated with significantly improved regional nodal control at 5 years (regional control rate of 100% for ENI vs 82%, P ENI developed isolated neck recurrences. All had further treatment for their neck disease, including neck dissection (n = 10), radiation (n = 10), or chemotherapy (n = 5). Six of these 11 patients (54.5%) demonstrated no evidence of further recurrence with a median follow-up of 55.5 months. ENI significantly reduces the risk of cervical nodal recurrence in ENB patients with clinically N0 neck, but this did not translate to a survival benefit. Multimodality treatment for isolated neck recurrence provides a reasonable salvage rate. The greatest benefit for ENI appeared to be among younger patients who presented with Kadish C disease. Further studies are needed to confirm these findings. Copyright © 2016 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

The role of elective-nodal irradiation for esthesioneuroblastoma patients with clinically negative neck

Science.gov (United States)

Jiang, Wen; Mohamed, Abdallah Sherif; Fuller, Clifton David; Kim, Betty Y.S.; Tang, Chad; Gunn, G. Brandon; Hanna, Ehab Y.; Frank, Steven J.; Su, Shirley Y.; Diaz, Eduardo; Kupferman, Michael E.; Beadle, Beth M.; Morrison, William H.; Skinner, Heath; Lai, Stephen Y.; El-Naggar, Adel K.; DeMonte, Franco; Rosenthal, David I.; Garden, Adam S.; Phan, Jack

2017-01-01

Purpose Although adjuvant radiation to the tumor bed has been reported to improve the clinic outcomes of esthesioneuroblastoma (ENB) patients, the role of elective neck irradiation (ENI) in clinically node negative (N0) patients remains controversial. Here, we evaluated the effects of ENI on neck nodal relapse risk in ENB patients treated with radiotherapy as a component of multi-modality treatment. Methods and Materials Seventy-one N0 ENB patients irradiated at XXXXXXXXX between 1970 and 2013 were identified. ENI was performed on 22 of these patients (31%). Survival analysis was performed with focus on comparative outcomes of those patients who did and did not receive ENI. Results The median follow up time for our cohort is 80.8 months (range 6 – 350 month). Among N0 patients, 13 (18.3%) developed neck nodal relapses, with a median time to progression of 62.5 months. None of these 13 patients received prophylactic neck irradiation. ENI was associated with significantly improved regional nodal control at 5-year (regional control rate of 100% for ENI vs 82%, p ENI developed isolated neck recurrences. All had further treatment for their neck disease, including neck dissection (n=10), radiation (n=10), or chemotherapy (n=5). Six of these 11 patients (54.5%) demonstrated no evidence of further recurrence with a median follow up of 55.5 month. Conclusion ENI significantly reduces the risk of cervical nodal recurrence in ENB patients with clinically N0 neck but this did not translate to a survival benefit. Multimodality treatment for isolated neck recurrence provides a reasonable salvage rate. The greatest benefit for ENI appeared to be among younger patients who presented with Kadish C disease. Further studies are needed to confirm these findings. PMID:26979544

Clinical forms of shoulder instability in pediatric patients

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Yaroslav N. Proshchenko

2016-12-01

Full Text Available Background. The recurrence rate of adolescent chronic shoulder instability is approximately 56%–68%. However, this pathology is often missed in childhood and adolescence. Aim. To identify the clinical forms of shoulder joint instability in pediatric patients. Materials and methods. The authors present the data from 57 pediatric patients aged 3−17 years with a total of 61 unstable shoulder joints. All patients were divided into groups according to the form of instability. Traumatic chronic shoulder instability was identified in 40 patients (Bankart and Hill–Sachs injuries. Of these, non-traumatic shoulder instability was diagnose in 17, including five with recurrent dislocation, and spontaneous shoulder dislocation due to dysplasia of glenoid and labrum was diagnosed in 12. Of the 57 patients in the study cohort, 53 underwent surgery. Postoperatively, two patients developed recurrent shoulder dislocation (Andreev–Boichev technique due type III shoulder dysplasia in the first patient and multidirectional injury in the second. Conclusions. Shoulder joint instability should be considered as the traumatic or non-traumatic form. Treatment decisions should be based on anatomical characteristics that predispose to recurrent dislocation.

The development of a clinical outcomes survey research application: Assessment Center.

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Gershon, Richard; Rothrock, Nan E; Hanrahan, Rachel T; Jansky, Liz J; Harniss, Mark; Riley, William

2010-06-01

The National Institutes of Health sponsored Patient-Reported Outcome Measurement Information System (PROMIS) aimed to create item banks and computerized adaptive tests (CATs) across multiple domains for individuals with a range of chronic diseases. Web-based software was created to enable a researcher to create study-specific Websites that could administer PROMIS CATs and other instruments to research participants or clinical samples. This paper outlines the process used to develop a user-friendly, free, Web-based resource (Assessment Center) for storage, retrieval, organization, sharing, and administration of patient-reported outcomes (PRO) instruments. Joint Application Design (JAD) sessions were conducted with representatives from numerous institutions in order to supply a general wish list of features. Use Cases were then written to ensure that end user expectations matched programmer specifications. Program development included daily programmer "scrum" sessions, weekly Usability Acceptability Testing (UAT) and continuous Quality Assurance (QA) activities pre- and post-release. Assessment Center includes features that promote instrument development including item histories, data management, and storage of statistical analysis results. This case study of software development highlights the collection and incorporation of user input throughout the development process. Potential future applications of Assessment Center in clinical research are discussed.

Esophageal Lichen Planus: Clinical and Radiographic Findings in Eight Patients.

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Rauschecker, Andreas M; Levine, Marc S; Whitson, Matthew J; Tondon, Rashmi; Rubesin, Stephen E; Furth, Emma E; Metz, David C

2017-01-01

The purpose of this study is to present the clinical and radiographic findings of esophageal lichen planus. A search of computerized medical records identified 15 patients with pathologic findings of esophageal lichen planus on endoscopic biopsy specimens. Three other patients had presumed esophageal lichen planus, although no biopsy specimens were obtained. Twelve of these 18 patients (67%) had double-contrast esophagography performed at our institution; for eight of the 12 patients (67%), the studies revealed abnormalities in the esophagus. These eight patients constituted our study group. The barium esophagrams and medical records of these eight patients were reviewed to determine the clinical, radiographic, and endoscopic findings of esophageal lichen planus as well as the treatment and patient outcome. All eight patients were women (median age, 66.5 years), and all eight presented with dysphagia (mean duration, 3.2 years). Four patients had previous lichen planus that involved the skin (n = 1), the oral cavity (n = 2), or both (n = 1), and one patient later had lichen planus that involved the vagina. Five patients had a small-caliber esophagus with diffuse esophageal narrowing. The remaining three patients had segmental strictures in the cervical (n = 1), upper thoracic (n = 1), and distal thoracic (n = 1) esophagus. Esophageal lichen planus typically occurs in older women with longstanding dysphagia and often develops in the absence of extraesophageal disease. Barium esophagrams may reveal a small-caliber esophagus or, less commonly, segmental esophageal strictures. Greater awareness of the radiographic findings of esophageal lichen planus hopefully will lead to earlier diagnosis and better management of this condition.

Physician and patient characteristics associated with clinical inertia in blood pressure control.

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Harle, Christopher A; Harman, Jeffrey S; Yang, Shuo

2013-11-01

Clinical inertia, the failure to adjust antihypertensive medications during patient visits with uncontrolled hypertension, is thought to be a common problem. This retrospective study used 5 years of electronic medical records from a multispecialty group practice to examine the association between physician and patient characteristics and clinical inertia. Hierarchical linear models (HLMs) were used to examine (1) differences in physician and patient characteristics among patients with and without clinical inertia, and (2) the association between clinical inertia and future uncontrolled hypertension. Overall, 66% of patients experienced clinical inertia. Clinical inertia was associated with one physician characteristic, patient volume (odds ratio [OR]=0.998). However, clinical inertia was associated with multiple patient characteristics, including patient age (OR=1.021), commercial insurance (OR=0.804), and obesity (OR=1.805). Finally, patients with clinical inertia had 2.9 times the odds of uncontrolled hypertension at their final visit in the study period. These findings may aid the design of interventions to reduce clinical inertia. ©2013 Wiley Periodicals, Inc.

The Rules of Engagement: CTTI Recommendations for Successful Collaborations Between Sponsors and Patient Groups Around Clinical Trials.

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Bloom, Diane; Beetsch, Joel; Harker, Matthew; Hesterlee, Sharon; Moreira, Paulo; Patrick-Lake, Bray; Selig, Wendy; Sherman, Jeffrey; Smith, Sophia K; Valentine, James E; Roberts, Jamie N

2018-03-01

To identify the elements necessary for successful collaboration between patient groups and academic and industry sponsors of clinical trials, in order to develop recommendations for best practices for effective patient group engagement. In-depth interviews, informed by a previously reported survey, were conducted to identify the fundamentals of successful patient group engagement. Thirty-two respondents from 3 sectors participated: patient groups, academic researchers, and industry. The findings were presented to a multistakeholder group of experts in January 2015. The expert group came to consensus on a set of actionable recommendations for best practices for patient groups and research sponsors. Interview respondents acknowledged that not all patient groups are created equal in terms of what they can contribute to a clinical trial. The most important elements for effective patient group engagement include establishing meaningful partnerships, demonstrating mutual benefits, and collaborating as partners from the planning stage forward. Although there is a growing appreciation by sponsors about the benefits of patient group engagement, there remains some resistance and some uncertainty about how best to engage. Barriers include mismatched expectations and a perception that patient groups lack scientific sophistication and that "wishful thinking" may cloud their recommendations. Patient groups are developing diverse skillsets and acquiring assets to leverage in order to become collaborators with industry and academia on clinical trials. Growing numbers of research sponsors across the clinical trials enterprise are recognizing the benefits of continuous and meaningful patient group engagement, but there are still mindsets to change, and stakeholders need further guidance on operationalizing a new model of clinical trial conduct.

[Clinical pathway for hip fracture patients].

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Sáez López, Pilar; Sánchez Hernández, Natalia; Paniagua Tejo, Sonsoles; Valverde García, José Antonio; Montero Díaz, Margarita; Alonso García, Noelia; Freites Esteve, Alfonso

2015-01-01

Hip fracture in the elderly often occurs in patients with high co-morbidity. Effective management requires a comprehensive and multidisciplinary approach. To evaluate the effect of a quality improvement intervention in the detection and treatment of complications in elderly patients admitted for hip fracture. A comparative study was conducted between two groups of patients admitted for hip fracture prior to 2010, and after a quality improvement intervention in 2013. The intervention consisted of implementing improved multidisciplinary measures in accordance with recent scientific evidence. The degree of compliance of the implemented measures was quantified. Patients admitted due to hip fracture in 2010 (216 patients) and 2013 (196 patients) were similar in age, sex, Barthel Index, and a reduced Charlson Index, although there were more comorbidities in 2013. After implementation of the protocols, the detection of delirium, malnutrition, anemia, and electrolyte disturbances increased. A larger number of patients in 2013 were precribed intravenous iron (24% more) and osteoporosis treatment (61.3% more). The average stay was reduced by 45.3% and surgical delay by 29.4%, achieving better functional efficiency. The implementation of a clinical pathway in geriatric patients with hip fracture is useful to detect and treat complications at an early stage, and to reduce pre-operative and overall stay, all without a negative clinical or functional impact. Copyright © 2014 SEGG. Published by Elsevier Espana. All rights reserved.

[Clinical analysis of 15 pediatric patients with tuberous sclerosis complex complicated by cardiac rhabdomyomas].

Science.gov (United States)

Huang, Guo-Qiang; Zhai, Qiong-Xiang; Yu, Jun-Hao; Wang, Chun; Zhuo, Mu-Qing; Wang, Lin-Gan

2015-05-01

To investigate the clinical features in children with tuberous sclerosis complex (TSC)-associated cardiac rhabdomyomas (CRM). The clinical data of 15 children with TSC complicated by CRM were collected. The clinical features of the patients were analyzed, and TSC gene mutations were detected. Eleven cases (73%) developed multiple CRM. The majority of the tumors were located in the left and right ventricles. Most tumors presented as a round-like hyperechogenic mass with a clear margin on echocardiography. Arrhythmias occurred in 3 patients and 2 patients experienced heart failure. Gene mutation tests were performed in 2 patients, and pathogenic mutations were detected in both patients, which were TSC1 mutation and TSC2 mutation, respectively. Three patients were followed up for 6 to 38 months, and their CRM shrank or regressed spontaneously. TSC-associated CRM is generally multiple. Heart failure and arrhythmias may occur in some patients. Echocardiography is important for diagnosis of CRM. TSC-associated CRM has an inclination to spontaneous regression. TSC can be diagnosed at a molecular genetic level by TSC gene mutation detection.

Prediction of overall survival for patients with metastatic castration-resistant prostate cancer: development of a prognostic model through a crowdsourced challenge with open clinical trial data.

Science.gov (United States)

Guinney, Justin; Wang, Tao; Laajala, Teemu D; Winner, Kimberly Kanigel; Bare, J Christopher; Neto, Elias Chaibub; Khan, Suleiman A; Peddinti, Gopal; Airola, Antti; Pahikkala, Tapio; Mirtti, Tuomas; Yu, Thomas; Bot, Brian M; Shen, Liji; Abdallah, Kald; Norman, Thea; Friend, Stephen; Stolovitzky, Gustavo; Soule, Howard; Sweeney, Christopher J; Ryan, Charles J; Scher, Howard I; Sartor, Oliver; Xie, Yang; Aittokallio, Tero; Zhou, Fang Liz; Costello, James C

2017-01-01

fifth trial-ENTHUSE M1-in which 266 patients with metastatic castration-resistant prostate cancer were treated with placebo alone. 50 independent methods were developed to predict overall survival and were evaluated through the DREAM challenge. The top performer was based on an ensemble of penalised Cox regression models (ePCR), which uniquely identified predictive interaction effects with immune biomarkers and markers of hepatic and renal function. Overall, ePCR outperformed all other methods (iAUC 0·791; Bayes factor >5) and surpassed the reference model (iAUC 0·743; Bayes factor >20). Both the ePCR model and reference models stratified patients in the ENTHUSE 33 trial into high-risk and low-risk groups with significantly different overall survival (ePCR: hazard ratio 3·32, 95% CI 2·39-4·62, p<0·0001; reference model: 2·56, 1·85-3·53, p<0·0001). The new model was validated further on the ENTHUSE M1 cohort with similarly high performance (iAUC 0·768). Meta-analysis across all methods confirmed previously identified predictive clinical variables and revealed aspartate aminotransferase as an important, albeit previously under-reported, prognostic biomarker. Novel prognostic factors were delineated, and the assessment of 50 methods developed by independent international teams establishes a benchmark for development of methods in the future. The results of this effort show that data-sharing, when combined with a crowdsourced challenge, is a robust and powerful framework to develop new prognostic models in advanced prostate cancer. Sanofi US Services, Project Data Sphere. Copyright © 2017 Elsevier Ltd. All rights reserved.

[Development and clinical evaluation of an anesthesia information management system].

Science.gov (United States)

Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

2010-09-21

To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

Experiences with developing and implementing a virtual clinic for glaucoma care in an NHS setting

Directory of Open Access Journals (Sweden)

Kotecha A

2015-10-01

Full Text Available Aachal Kotecha,1,2 Alex Baldwin,1 John Brookes,1 Paul J Foster1,2 1Glaucoma Service, Moorfields Eye Hospital National Health Service Foundation Trust, 2NIHR BRC, Moorfields Eye Hospital, NHS Foundation Trust and UCL Institute of Ophthalmology, University College London, London, UK Background: This article describes the development of a virtual glaucoma clinic, whereby technicians collect information for remote review by a consultant specialist.Design and Methods: This was a hospital-based service evaluation study. Patients suitable for the stable monitoring service (SMS were low-risk patients with “suspect”, “early”-to-“moderate” glaucoma who were deemed stable by their consultant care team. Three technicians and one health care assistant ran the service. Patients underwent tests in a streamlined manner in a dedicated clinical facility, with virtual review of data by a consultant specialist through an electronic patient record.Main outcome measure: Feasibility of developing a novel service within a UK National Health Service setting and improvement of patient journey time within the service were studied.Results: Challenges to implementation of virtual clinic include staffing issues and use of information technology. Patient journey time within the SMS averaged 51 minutes, compared with 92 minutes in the glaucoma outpatient department. Patient satisfaction with the new service was high.Conclusion: Implementing innovation into existing services of the National Health Service is challenging. However, the virtual clinic showed an improved patient journey time compared with that experienced within the general glaucoma outpatient department. There exists a discrepancy between patient management decisions of reviewers, suggesting that some may be more risk averse than others when managing patients seen within this model. Future work will assess the ability to detect progression of disease in this model compared with the general

Clinical and CT analysis of GCS 15 patients with intracranial hemorrhage

International Nuclear Information System (INIS)

Yang Lin; He Jianyuan; Jiang Shanyue; Zhang Yanling

2007-01-01

Objective: To analyze the clinical symptoms and CT manifestations of GCS 15 patients with intracranial hemorrhage. Methods: Clinical data and manifestations of the CT images of 35 patients with GCS 15 and intracranial hemorrhage were retrospectively analyzed and followed up. in short term. Results: Clinical symptoms: Deficits in short-term memory appeared in 17% of patients, vomiting in 26%, headache in 97%, physical evidence of trauma above the clavicles in 100%. CT scanning: intracerebral hemorrhage occurred in 18 patients, epidural hemorrhage in 9 patients, subarachnoid hemorrhage in 8 patients, subdural hemorrhage in 7 patients. During follow up, clinical severe degree was in consistent of craniocerebral CT scanning. Conclusion: For patients with GCS 15 brain injuries early head CT scanning is very important. Intracranial hemorrhage may occur in these patients. If possible, re-assessment of clinical examination and CT scanning is remarkably necessary. (authors)

Methodology of clinical measures of healthcare quality delivered to patients with cardiovascular diseases

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Posnenkova O.M.

2014-03-01

Full Text Available The results of implementation the methodology proposed by American Colleague of Cardiology and American Heart Association (ACC/AHA for development of Russian clinical quality measures for patients with arterial hypertension, coronary heart disease and chronic heart failure. Created quality measures cover the key elements of medical care influencing directly on clinical outcomes of treatment.

The CARE guidelines: consensus-based clinical case report guideline development.

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Gagnier, Joel J; Kienle, Gunver; Altman, Douglas G; Moher, David; Sox, Harold; Riley, David

2014-01-01

A case report is a narrative that describes, for medical, scientific, or educational purposes, a medical problem experienced by one or more patients. Case reports written without guidance from reporting standards are insufficiently rigorous to guide clinical practice or to inform clinical study design. Develop, disseminate, and implement systematic reporting guidelines for case reports. We used a three-phase consensus process consisting of (1) pre-meeting literature review and interviews to generate items for the reporting guidelines, (2) a face-to-face consensus meeting to draft the reporting guidelines, and (3) post-meeting feedback, review, and pilot testing, followed by finalization of the case report guidelines. This consensus process involved 27 participants and resulted in a 13-item checklist-a reporting guideline for case reports. The primary items of the checklist are title, key words, abstract, introduction, patient information, clinical findings, timeline, diagnostic assessment, therapeutic interventions, follow-up and outcomes, discussion, patient perspective, and informed consent. We believe the implementation of the CARE (CAse REport) guidelines by medical journals will improve the completeness and transparency of published case reports and that the systematic aggregation of information from case reports will inform clinical study design, provide early signals of effectiveness and harms, and improve healthcare delivery. Copyright © 2014 Reproduced with permission of Global Advances in Health and Medicine. Published by Elsevier Inc. All rights reserved.

Development of an online clinical trial recruitment portal for the NIHR mental health BRC.

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Markham, Sarah

2016-01-01

; many said yes, they would. The manager of the BRC on reviewing the website, agreed that a final version of the website with the NIHR Mental Health BRC logo would be paid for and will form part of a new main website for the BRC in early 2016. ᅟ. Public & patient recruitment to clinical trials is viewed as one of the main barriers to the implementation of clinical trials. This difficulty is often attributed to the working culture of the NHS, rapid turnover of staff and patients and poor-gatekeeping in referring patients to suitable clinical trials. In response to the recruitment difficulties experienced by the Psychosis Studies Clinical Academic Group at the NIHR Mental Health Biomedical Research Centre, Denmark Hill, London, a member of the Office of Psychosis Studies at King's College London and a member (the author) of the King's Clinical Trials Unit, King's College London developed an initiative to create an online clinical trial recruitment portal/information hub for the NIHR Mental Health BRC. The primary purpose of this initiative being to promote patient and public awareness of and interest in participating in clinical trials.

Celiac Patients: A Randomized, Controlled Clinical Study

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Giuseppe Mazzarella

2012-01-01

Full Text Available A lifelong gluten-free diet (GFD is mandatory for celiac disease (CD but has poor compliance, justifying novel strategies. We found that wheat flour transamidation inhibited IFN-γ secretion by intestinal T cells from CD patients. Herein, the primary endpoint was to evaluate the ability of transamidated gluten to maintain GFD CD patients in clinical remission. Secondary endpoints were efficacy in prevention of the inflammatory response and safety at the kidney level, where reaction products are metabolized. In a randomized single blinded, controlled 90-day trial, 47 GFD CD patients received 3.7 g/day of gluten from nontransamidated (12 or transamidated (35 flour. On day 15, 75% and 37% of patients in the control and experimental groups, respectively, showed clinical relapse (=0.04 whereas intestinal permeability was mainly altered in the control group (50% versus 20%, =0.06. On day 90, 0 controls and 14 patients in the experimental group completed the challenge with no variation of antitransglutaminase IgA (=0.63, Marsh-Oberhuber grading (=0.08, or intestinal IFN-γ mRNA (>0.05. Creatinine clearance did not vary after 90 days of treatment (=0.46. In conclusion, transamidated gluten reduced the number of clinical relapses in challenged patients with no changes of baseline values for serological/mucosal CD markers and an unaltered kidney function.

The ENDOCARE questionnaire guides European endometriosis clinics to improve the patient-centeredness of their care.

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Dancet, E A F; Apers, S; Kluivers, K B; Kremer, J A M; Sermeus, W; Devriendt, C; Nelen, W L D M; D'Hooghe, T M

2012-11-01

How patient-centered are two included specialized endometriosis clinics relative to each other and how can they improve the patient-centeredness of their care? The validated ENDOCARE questionnaire (ECQ) reliably concluded that the adjusted overall patient-centeredness did not differ between the clinics, that each clinic was significantly more patient-centered for 2 out of 10 dimensions of patient-centered endometriosis care and that clinics 1 and 2 had to improve 8 and 13 specific care aspects, respectively. Patient-centered endometriosis care is essential to high-quality care and is defined by 10 dimensions. The ECQ was developed, validated and proved to be reliable in a European setting of self-reported endometriosis patients but had not yet been used at a clinic level for quality management. A cross-sectional survey was disseminated in 2011 to all 514 women diagnosed with endometriosis during a laparoscopy indicated for pain and/or infertility during a retrospective 2-year period (2009-2010) in two university clinics from two different European countries. In total 337 patients completed the ECQ (216 and 121 per clinic). Respondents had a mean age of 34.3 years. Three in four reported a surgical diagnosis of moderate or severe endometriosis and the majority reported surgical treatment by a multidisciplinary team. The ECQ assessed the 10 dimensions of patient-centeredness, more specifically whether the health-care performance, as perceived by patients, measured up to what is important to patients in general. The ECQ was completed by 337 respondents (response rate = 65.6%). Reliability and validity of the ECQ for use on clinic level were confirmed. Clinics did not differ in overall mean importance scores; importance rankings of the ECQ dimensions were almost identical. The overall patient-centeredness scores (PCS), adjusted for education level, did not discriminate between the clinics. However, the adjusted PCS for the dimensions 'clinic staff' and 'technical

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.

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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.

Patient Satisfaction Is Associated With Time With Provider But Not Clinic Wait Time Among Orthopedic Patients.

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Patterson, Brendan M; Eskildsen, Scott M; Clement, R Carter; Lin, Feng-Chang; Olcott, Christopher W; Del Gaizo, Daniel J; Tennant, Joshua N

2017-01-01

Clinic wait time is considered an important predictor of patient satisfaction. The goal of this study was to determine whether patient satisfaction among orthopedic patients is associated with clinic wait time and time with the provider. The authors prospectively enrolled 182 patients at their outpatient orthopedic clinic. Clinic wait time was defined as the time between patient check-in and being seen by the surgeon. Time spent with the provider was defined as the total time the patient spent in the examination room with the surgeon. The Consumer Assessment of Healthcare Providers and Systems survey was used to measure patient satisfaction. Factors associated with increased patient satisfaction included patient age and increased time with the surgeon (P=.024 and P=.037, respectively), but not clinic wait time (P=.625). Perceived wait time was subject to a high level of error, and most patients did not accurately report whether they had been waiting longer than 15 minutes to see a provider until they had waited at least 60 minutes (P=.007). If the results of the current study are generalizable, time with the surgeon is associated with patient satisfaction in orthopedic clinics, but wait time is not. Further, the study findings showed that patients in this setting did not have an accurate perception of actual wait time, with many patients underestimating the time they waited to see a provider. Thus, a potential strategy for improving patient satisfaction is to spend more time with each patient, even at the expense of increased wait time. [Orthopedics. 2017; 40(1):43-48.]. Copyright 2016, SLACK Incorporated.

Synthesis maps: visual knowledge translation for the CanIMPACT clinical system and patient cancer journeys.

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Jones, P H; Shakdher, S; Singh, P

2017-04-01

Salient findings and interpretations from the canimpact clinical cancer research study are visually represented in two synthesis maps for the purpose of communicating an integrated presentation of the study to clinical cancer researchers and policymakers. Synthesis maps integrate evidence and expertise into a visual narrative for knowledge translation and communication. A clinical system synthesis map represents the current Canadian primary care and cancer practice systems, proposed as a visual knowledge translation from the mixed-methods canimpact study to inform Canadian clinical research, policy, and practice discourses. Two synthesis maps, drawn together from multiple canimpact investigations and sources, were required to articulate critical differences between the clinical system and patient perspectives. The synthesis map of Canada-wide clinical cancer systems illustrates the relationships between primary care and the full cancer continuum. A patient-centred map was developed to represent the cancer (and primary care) journeys as experienced by breast and colorectal cancer patients.

clinical characteristics of cataract patients with pseudoexfoliation

African Journals Online (AJOL)

User

the clinical characteristics of pseudoexfoliation syndrome among cataract patients examined at ... CONCLUSION: A significant number of patients with PEX had poor zonular integrity and high IOP ... Poor zonular integrity may give rise to.

Developing an advanced practice nurse-led liver clinic.

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McAfee, Jean L

2012-01-01

End-stage liver disease (ESLD) is a leading cause of digestive disease deaths in the United States and continues to increase exponentially every year. Best practice does not currently recognize or utilize a clinic practice model for ESLD management. Advanced practice registered nurses (APRNs) can impact ESLD disease management by implementing an outpatient clinic care model to focus on treatment compliance, patient education, improvement of patient outcomes, and reduction in hospital admission rates for ESLD patients. A review of 15 research articles was completed to determine the impact APRNs can make on chronic care of ESLD patients. Results from the review support APRN analysis, assessment, diagnosis, treatment, intervention, and evaluation of ESLD patients. The literature reviewed also demonstrates that ESLD patients have improved symptom management when maintained in an outpatient setting, allowing for decreased hospital and insurance expenditures. Following evaluation of the evidence, it was concluded that an APRN-led ESLD clinic merits further study.

Multi-regional clinical trials and global drug development

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Premnath Shenoy

2016-01-01

Full Text Available Drug development has been globalized, and multi-regional clinical trial (MRCT for regulatory submission has widely been conducted by many discovery based global pharmaceutical companies with the objective of reducing the time lag of launch in key markets and improve patient access to new and innovative treatments. Sponsors are facing several challenges while conducting multiregional clinical trials. Challenges under the heads statistics, clinical, regulatory operational, and ethics have been discussed. Regulators in different countries such as USA, EU-Japan, and China have issued guidance documents in respect of MRCT's. Lack of harmonization in the design and planning of MRCT is perceived to create a difficult situation to sponsors adversely affecting progressing MRCT in more and more discoveries. International conference on hormonisation (ICH has initiated the process for having a harmonized guidance document on MRCT. This document is likely to be issued in early 2017.

Internet and Email Use Among STD Clinic Patients

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Mark, Karen E.; Wald, Anna; Drolette, Linda; Golden, Matthew R.

2009-01-01

Background Little data exist on Internet and email use among STD clinic patients for research and clinical care communication. Methods An anonymous cross-sectional survey of STD clinic patients aged ≥ 18 years in Seattle, Washington, March 13–22, 2006. Results Of 489 study period patients, 251 (51%) completed the questionnaire. Participants had a median age of 30 (range 18–66) years and were 69% male, 56% White, 19% African-American, 9% Hispanic, and 7% Asian/Pacific Islander. 75% had some post-secondary education but half reported an annual income of email that they check at least 3 times a week, and 144 (57%) were willing to receive an email reminding them to come back for a follow-up appointment if diagnosed with an STD. MSM were more likely than women and heterosexual men to be regular Internet and email users (92% versus 70%, p = 0.001) and to have met a sex partner over the Internet during the past year (69% versus 11%, p email use, as was racial/ethnic background (86% of Whites, 48% of African-Americans, 73% of Hispanics, 100% of Asians/Pacific Islanders, and 57% of others, p email use are common and acceptable to many STD clinic patients for research and clinical purposes. PMID:18685548

Normal cellular radiosensitivity in an adult Fanconi anaemia patient with marked clinical radiosensitivity

International Nuclear Information System (INIS)

Marcou, Yiola; D'Andrea, Andrew; Jeggo, Penelope A.; Plowman, Piers N.

2001-01-01

Background: Fanconi anaemia is a rare disease associated with cellular sensitivity to chemicals (e.g. mitomycin C and diepoxybutane); variable but mild cellular radiosensitivity has also been reported. Materials and methods: A 32-year-old patient with Fanconi anaemia and tonsillar carcinoma, treated by radiotherapy, was found to exhibit profound clinical radiosensitivity. Confluent, ulcerating oropharyngeal mucositis developed after a conventionally fractionated dose of 34 Gy and healing was incomplete by 2 months after cessation of therapy. Results: Cellular radiosensitivity assays and RPLD studies from this patient did not suggest any major detectable radiosensitivity. Conclusion: There is a discrepancy between the observed clinical radiosensitivity and the usual 'predictive' radiosensitivity assays in this patient with Fanconi anaemia

PhenoTips: patient phenotyping software for clinical and research use.

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Girdea, Marta; Dumitriu, Sergiu; Fiume, Marc; Bowdin, Sarah; Boycott, Kym M; Chénier, Sébastien; Chitayat, David; Faghfoury, Hanna; Meyn, M Stephen; Ray, Peter N; So, Joyce; Stavropoulos, Dimitri J; Brudno, Michael

2013-08-01

We have developed PhenoTips: open source software for collecting and analyzing phenotypic information for patients with genetic disorders. Our software combines an easy-to-use interface, compatible with any device that runs a Web browser, with a standardized database back end. The PhenoTips' user interface closely mirrors clinician workflows so as to facilitate the recording of observations made during the patient encounter. Collected data include demographics, medical history, family history, physical and laboratory measurements, physical findings, and additional notes. Phenotypic information is represented using the Human Phenotype Ontology; however, the complexity of the ontology is hidden behind a user interface, which combines simple selection of common phenotypes with error-tolerant, predictive search of the entire ontology. PhenoTips supports accurate diagnosis by analyzing the entered data, then suggesting additional clinical investigations and providing Online Mendelian Inheritance in Man (OMIM) links to likely disorders. By collecting, classifying, and analyzing phenotypic information during the patient encounter, PhenoTips allows for streamlining of clinic workflow, efficient data entry, improved diagnosis, standardization of collected patient phenotypes, and sharing of anonymized patient phenotype data for the study of rare disorders. Our source code and a demo version of PhenoTips are available at http://phenotips.org. © 2013 WILEY PERIODICALS, INC.

[Development of Diagrammatic Recording System for Choledochoscope and Its Clinical Application].

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Xue, Zhao; Hu, Liangshuo; Tang, Bo; Zhang, Xiaogang; Lyu, Yi

2017-11-30

To develop a diagrammatic recording system for choledochoscopy and evaluate the system with clinical application. To match the real-time image and procedure illustration during choledochoscopy examination, we combined video-image capture and speech recognition technology to quickly generate personalized choledochoscopy images and texts records. The new system could be used in sharing territorial electronic medical records, telecommuting, scientific research and education, et al. In the clinical application of 32 patients, the choledochoscopy diagrammatic recording system could significantly improve the surgeons' working efficiency and patients' satisfaction. It could also meet the design requirement of remote information interaction. The choledochoscopy diagrammatic recording system which is recommended could elevate the quality of medical service and promote academic exchange and training.

Patient and Provider Factors Affecting Clinical Inertia in Patients With Type 2 Diabetes on Metformin Monotherapy.

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Mahabaleshwarkar, Rohan; Gohs, Frank; Mulder, Holly; Wilkins, Nick; DeSantis, Andrea; Anderson, William E; Ejzykowicz, Flavia; Rajpathak, Swapnil; Norton, H James

2017-08-01

Our aim was to determine the extent of clinical inertia and the associated patient and provider factors in patients with type 2 diabetes on metformin monotherapy (MM) at a large integrated health care system in the United States. The study cohort included patients with type 2 diabetes aged 18 to 85 years, on MM between January 2009 and September 2013, who experienced MM failure (had an uncontrolled glycosylated hemoglobin [HbA 1c ] reading (≥8.0% [64 mmol/mol]) after at least 90 days of MM). Clinical inertia was defined as absence of treatment intensification with an add-on therapy within 180 days after the MM failure (index date). The impact of patient and provider factors on clinical inertia was determined using generalized estimating equations. The study cohort consisted of 996 patients; 58% were men and 59% were white, with a mean age of 53 (11.8) years. Of these, 49.8% experienced clinical inertia. Lower HbA 1c at index date, absence of liver diseases, absence of renal diseases, and greater provider age were associated with clinical inertia. The clinical inertia rate in a secondary analysis considering HbA 1c inertia. Considerable clinical inertia rates were observed in our real-world patient population, suggesting the need of interventions to reduce clinical inertia in clinical practice. Information about patient and provider factors affecting clinical inertia provided by this study could help healthcare policymakers plan and implement such interventions. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

Clinical and Autoimmune Profile of Scleroderma Patients from Western India

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Vandana Pradhan

2014-01-01

Full Text Available Background. Systemic sclerosis (SSc, scleroderma is a disorder characterized by fibrosis of skin and visceral organs. Pathogenesis of scleroderma is complex and is incompletely understood as yet. Autoantibodies in SSc represent a serologic hallmark which have clinical relevance, with diagnostic and prognostic potential. Objectives. To study distribution of clinical manifestations and to identify frequency of autoantibodies among subtypes of scleroderma patients from Western India. Methodology. One hundred and ten scleroderma patients were clinically classified according to the American College of Rheumatology/European League Against Rheumatism (ACR/EULAR criteria. All these patients were in active stage of disease. Clinical manifestations were recorded at the time of presentation. Autoantibodies were tested in them by indirect immunofluorescence test and ELISA. Immunoglobulin levels were estimated by nephelometer. These parameters were further correlated with clinical presentation of the disease. Results. Scleroderma patients had M : F ratio of 1 : 10 where mean age at evaluation was 34.7±10.7 years and a mean disease duration was 43.7±35 months. Clinical subtypes showed that 45 patients (40.9% had diffused cutaneous (dcSSc lesions, 32 patients (29.1% had limited cutaneous (lcSSc lesions, and 33 patients (30% had other autoimmune overlaps. The overall frequency of ANA in SSc patients studied was 85.5%. The frequency of anti-Scl70, anti-centromere, anti-endothelial cell antibodies (AECA, and anti-keratinocyte antibodies (AKA was 62.7%, 22.7%, 30%, and 40.9%, respectively. Anti-Scl70 antibodies were significantly high (75.6% versus 46.9% among dcSSc patients (P<0.0115 whereas anti-centromere antibodies were significantly high (9% versus 38% among lcSSc patients when these two subtypes were compared (P<0.0044. Conclusion. This study supports that there are geoepidemiological variations among scleroderma patients for their clinical

Clinical diagnosis of hyposalivation in hospitalized patients

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Soraya de Azambuja Berti-Couto

2012-04-01

Full Text Available OBJECTIVE: The aim of this study was to evaluate the effectiveness of clinical criteria for the diagnosis of hyposalivation in hospitalized patients. MATERIAL AND METHODS: A clinical study was carried out on 145 subjects (48 males; 97 females; aged 20 to 90 years. Each subject was clinically examined, in the morning and in the afternoon, along 1 day. A focused anamnesis allowed identifying symptoms of hyposalivation, like xerostomia complaints (considered as a reference symptom, chewing difficulty, dysphagia and increased frequency of liquid intake. Afterwards, dryness of the mucosa of the cheecks and floor of the mouth, as well as salivary secretion during parotid gland stimulation were assessed during oral examination. RESULTS: Results obtained with Chi-square tests showed that 71 patients (48.9% presented xerostomia complaints, with a significant correlation with all hyposalivation symptoms (p <0.05. Furthermore, xerostomia was also significantly correlated with all data obtained during oral examination in both periods of evaluation (p<0.05. CONCLUSION: Clinical diagnosis of hyposalivation in hospitalized patients is feasible and can provide an immediate and appropriate therapy avoiding further problems and improving their quality of life.

Knowing 'something is not right' is beyond intuition: development of a clinical algorithm to enhance surveillance and assist nurses to organise and communicate clinical findings.

Science.gov (United States)

Brier, Jessica; Carolyn, Moalem; Haverly, Marsha; Januario, Mary Ellen; Padula, Cynthia; Tal, Ahuva; Triosh, Henia

2015-03-01

To develop a clinical algorithm to guide nurses' critical thinking through systematic surveillance, assessment, actions required and communication strategies. To achieve this, an international, multiphase project was initiated. Patients receive hospital care postoperatively because they require the skilled surveillance of nurses. Effective assessment of postoperative patients is essential for early detection of clinical deterioration and optimal care management. Despite the significant amount of time devoted to surveillance activities, there is lack of evidence that nurses use a consistent, systematic approach in surveillance, management and communication, potentially leading to less optimal outcomes. Several explanations for the lack of consistency have been suggested in the literature. Mixed methods approach. Retrospective chart review; semi-structured interviews conducted with expert nurses (n = 10); algorithm development. Themes developed from the semi-structured interviews, including (1) complete, systematic assessment, (2) something is not right (3) validating with others, (4) influencing factors and (5) frustration with lack of response when communicating findings were used as the basis for development of the Surveillance Algorithm for Post-Surgical Patients. The algorithm proved beneficial based on limited use in clinical settings. Further work is needed to fully test it in education and practice. The Surveillance Algorithm for Post-Surgical Patients represents the approach of expert nurses, and serves to guide less expert nurses' observations, critical thinking, actions and communication. Based on this approach, the algorithm assists nurses to develop skills promoting early detection, intervention and communication in cases of patient deterioration. © 2014 John Wiley & Sons Ltd.

Cardiovascular abnormalities in patients with oral cleft: a clinical-electrocardiographic-echocardiographic study

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Gisele C.P. Leite

2018-04-01

Full Text Available OBJECTIVES: The present study aims to describe the clinical, electrocardiographic, and echocardiographic cardiological findings in a group of patients with oral clefts. METHODS: This is a prospective cross-sectional study on 70 children (age range from 13 days to 19 years with oral clefts who attended the multidisciplinary program of a university hospital from March 2013 to September 2014. The patients were evaluated by a pediatric cardiologist and underwent detailed anamnesis, physical examination, electrocardiogram, and echocardiogram. RESULTS: Sixty percent of the patients were male; 55.7% presented with cleft lip and palate, and 40.0% presented with health complaints. Comorbidities were found in 44.3%. Relevant pregnancy, neonatal, family and personal antecedents were present in 55.7%, 27.1%, 67.2%, and 24.3% of the patients, respectively. Regarding the antecedents, 15.2% of the patients presented with a cardiac murmur, 49.0% with a familial risk of developing plurimetabolic syndrome, and 6% with family antecedents of rheumatic fever. Electrocardiographic evaluation showed one case of atrioventricular block. Echocardiograms were abnormal in 35.7% of the exams, including 5 cases of mitral valve prolapse — one of which was diagnosed with rheumatic heart disease. CONCLUSION: The finding of a family risk of developing plurimetabolic syndrome and a diagnosis of rheumatic heart disease indicates that patients with oral clefts may be more prone to developing acquired heart disease. Thus, our findings highlight the importance of anamnesis and methodological triangulation (clinical-electrocardiographic-echocardiographic in the investigation of patients with oral clefts and emphasize that cardiological follow-up to evaluate acquired and/or rhythm heart diseases is necessary. This strategy permits comorbidity prevention and individualized planned treatment.

A review of standardized patients in clinical education: Implications for speech-language pathology programs.

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Hill, Anne E; Davidson, Bronwyn J; Theodoros, Deborah G

2010-06-01

The use of standardized patients has been reported as a viable addition to traditional models of professional practice education in medicine, nursing and allied health programs. Educational programs rely on the inclusion of work-integrated learning components in order to graduate competent practitioners. Allied health programs world-wide have reported increasing difficulty in attaining sufficient traditional placements for students within the workplace. In response to this, allied health professionals are challenged to be innovative and problem-solving in the development and maintenance of clinical education placements and to consider potential alternative learning opportunities for students. Whilst there is a bank of literature describing the use of standardized patients in medicine and nursing, reports of its use in speech-language pathology clinical education are limited. Therefore, this paper aims to (1) provide a review of literature reporting on the use of standardized patients within medical and allied health professions with particular reference to use in speech-language pathology, (2) discuss methodological and practical issues involved in establishing and maintaining a standardized patient program and (3) identify future directions for research and clinical programs using standardized patients to build foundation clinical skills such as communication, interpersonal interaction and interviewing.

Enhancing decision making about participation in cancer clinical trials: development of a question prompt list

Science.gov (United States)

Brown, Richard F.; Shuk, Elyse; Leighl, Natasha; Butow, Phyllis; Ostroff, Jamie; Edgerson, Shawna; Tattersall, Martin

2016-01-01

Purpose Slow accrual to cancer clinical trials impedes the progress of effective new cancer treatments. Poor physician–patient communication has been identified as a key contributor to low trial accrual. Question prompt lists (QPLs) have demonstrated a significant promise in facilitating communication in general, surgical, and palliative oncology settings. These simple patient interventions have not been tested in the oncology clinical trial setting. We aimed to develop a targeted QPL for clinical trials (QPL-CT). Method Lung, breast, and prostate cancer patients who either had (trial experienced) or had not (trial naive) participated in a clinical trial were invited to join focus groups to help develop and explore the acceptability of a QPL-CT. Focus groups were audio-recorded and transcribed. A research team, including a qualitative data expert, analyzed these data to explore patients’ decision-making processes and views about the utility of the QPL-CT prompt to aid in trial decision making. Results Decision making was influenced by the outcome of patients’ comparative assessment of perceived risks versus benefits of a trial, and the level of trust patients had in their doctors’ recommendation about the trial. Severity of a patient’s disease influenced trial decision making only for trial-naive patients. Conclusion Although patients were likely to prefer a paternalistic decision-making style, they expressed valuation of the QPL as an aid to decision making. QPL-CT utility extended beyond the actual consultation to include roles both before and after the clinical trial discussion. PMID:20593202

Cognitive development, clinical knowledge, and clinical experience related to diagnostic ability.

Science.gov (United States)

Aquilino, M L

1997-01-01

To examine the relationship among cognitive development, clinical knowledge, and clinical experience in nursing students. A survey of junior and senior baccalaureate nursing students from three Midwestern colleges (N = 55). Students' diagnostic ability increased as they gained clinical experience and clinical knowledge. However, students failed to identify many nursing diagnoses and demonstrated only moderate levels of cognitive development. Nurse educators and nursing students need to change their approaches to teaching and learning to enhance students' diagnostic ability and cognitive development.

Health Professionals Facing Suicidal Patients: What Are Their Clinical Practices?

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Inês Rothes

2018-06-01

Full Text Available Clinical work with suicidal people is a demanding area. Little is known about health professionals’ practices when faced with suicidal patients. The aims of this study were to: (1 describe the practices most likely to be adopted by professionals facing a suicidal patient and (2 analyze the differences according to professional characteristics (group, specific training on suicide, and experience with suicidal patients. A self-report questionnaire that was developed for this study was filled out by 239 participants. Participants were psychologists, psychiatrists, and general practitioners who work in different contexts: hospitals, public health centres, schools or colleges, and community centres. Principal components analysis, analyses of variance, and t-tests were used. Four components were identified: (1 Comprehensive risk assessment; (2 protocols, psychotherapy and connectedness; (3 multidisciplinary clinical approach; and, (4 family, explaining a total of variance of 44%. Positive associations between suicide-related variables (training and experience and practices were found. In general, health professionals’ practices are evidence-based, however a relevant percentage of professionals can benefit from training and improve their practices.

Clinical outcomes of hydronephrosis in patients with systemic lupus erythematosus.

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Hong, Seokchan; Kim, Yong-Gil; Ahn, Soo Min; Bae, Seung-Hyeon; Lim, Doo-Ho; Kim, Jeong Kon; Lee, Chang-Keun; Yoo, Bin

2016-12-01

Hydronephrosis is a rare complication of systemic lupus erythematosus (SLE). Bladder and/or gastrointestinal involvement in SLE are associated with development of hydronephrosis, but the management and treatment outcomes of hydronephrosis are largely unknown. Therefore, we investigated the clinical manifestations and factors associated with the treatment response in patients with SLE complicated by hydronephrosis. A retrospective analysis was performed of all 634 SLE patients who underwent computed tomography and/or ultrasonography between January 1998 and December 2013. We reviewed the clinical characteristics and treatment outcomes of patients with SLE-associated hydronephrosis. Hydronephrosis was identified in 15 patients with SLE complicated by cystitis and/or enteritis. All patients were treated initially with moderate to high doses of corticosteroids. A follow-up imaging study showed that 11 (73.3%) of 15 patients experienced improvements in hydronephrosis, and urinary obstruction was resolved without urological intervention in the majority of these patients (8/11, 72.7%). The four patients who experienced no improvement in hydronephrosis were older than those who responded to treatment (median age [interquartile range]; 43.0 [37.5-53.0] years vs. 28.0 [21.0-38.5] years; P = 0.026). In addition, delayed treatment (≥ 1 month after onset of symptoms) with corticosteroids was more frequently observed in the non-responding patients than in the responding patients (P = 0.011). Our findings suggest that treatment with corticosteroids alone leads to favorable outcomes in patients with SLE-associated hydronephrosis, except when treatment is delayed, particularly in elderly patients. © 2015 Asia Pacific League of Associations for Rheumatology and Wiley Publishing Asia Pty Ltd.

Clinical and para-clinical tests in the routine examination of headache patients

DEFF Research Database (Denmark)

Friberg, L; Sandrini, G; Jänig, W

2000-01-01

Para-clinical examinations in the diagnosis and treatment control of headache patients vary considerably between clinics and headache centers. Among the neurological societies in Europe there has been a consensus that some common procedures and recommendations should be created. In the Fall of 19...

Clinical trials in hospitalized heart failure patients: targeting interventions to optimal phenotypic subpopulations.

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Vaduganathan, Muthiah; Butler, Javed; Roessig, Lothar; Fonarow, Gregg C; Greene, Stephen J; Metra, Marco; Cotter, Gadi; Kupfer, Stuart; Zalewski, Andrew; Sato, Naoki; Filippatos, Gerasimos; Gheorghiade, Mihai

2015-07-01

With one possible exception, the last decade of clinical trials in hospitalized heart failure (HHF) patients has failed to demonstrate improvement in long-term clinical outcomes. This trend necessitates a need to evaluate optimal drug development strategies and standards of trial conduct. It has become increasingly important to recognize the heterogeneity among HHF patients and the differential characterization of novel drug candidates. Targeting these agents to specific subpopulations may afford optimal net response related to the particular mode of action of the drug. Analyses of previous trials demonstrate profound differences in the baseline characteristics of patients enrolled across global regions and participating sites. Such differences may influence risks for events and interpretation of results. Therefore, the actual execution of trials and the epidemiology of HHF populations at the investigative sites must be taken into consideration. Collaboration among participating sites including the provision of registry data tailored to the planned development program will optimize trial conduct. Observational data prior to study initiation may enable sites to feedback and engage in protocol development to allow for feasible and valid clinical trial conduct. This site-centered, epidemiology-based network environment may facilitate studies in specific patient populations and promote optimal data collection and clear interpretation of drug safety and efficacy. This review summarizes the roundtable discussion held by a multidisciplinary team of representatives from academia, National Institutes of Health, industry, regulatory agencies, payers, and contract and academic research organizations to answer the question: Who should be targeted for novel therapies in HHF?

Development of a patient-doctor communication skills model for medical students.

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Lee, Young Hee; Lee, Young-Mee

2010-09-01

Communication is a core clinical skill that can be taught and learned. The authors intended to develop a patient-doctor communication model for teaching and assessing undergraduate medical students in Korea. To develop a model, literature reviews and an iterative process of discussion between faculty members of a communication skills course for second year medical students were conducted. The authors extracted common communication skill competencies by comparing the Kalamazoo Consensus Statement, SEGUE framework communication skills, the Calgary Cambridge Observation Guides, and previous communication skills lists that have been used by the authors. The content validity, with regard to clinical importance and feasibility, was surveyed by both faculty physicians and students. The first version of the model consisted of 36 items under 7 categories: initiating the session (8 items), building a relationship (6), gathering information (8), understanding a patient's perspectives (4), sharing information (4), reaching an agreement (3), and closing the session (3). It was used as a guide for both students and teachers in an actual communication skills course. At the end of the course, student performance was assessed using two 7-minute standardized patient interviews with a 34-item checklist. This assessment tool was modified from the first version of the model to reflect the case specificity of the scenarios. A patient-doctor communication model, which can be taught to those with limited patient care experience, was finally developed. We recommended a patient-doctor communication skills model that can be used for teaching and evaluating preclinical and clinical students. Further studies are needed to verify its validity and reliability.

Pressure Ulcer Risk Evaluation in Critical Patients: Clinical and Social Characteristics.

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de Azevedo Macena, Mônica Suêla; da Costa Silva, Rayanne Suely; Dias Fernandes, Maria Isabel Da Conceição; de Almeida Medeiros, Ana Beatriz; Batista Lúcio, Kadyjina Daiane; de Carvalho Lira, Ana Luisa Brandão

2017-01-01

Pressure ulcers increase hospital stays and treatment costs due to their complications. Therefore, recognizing factors that contribute to pressure ulcer risk are important to patient safety. To evaluate the association between the scores of the Waterlow, Braden, and Norton scales and clinical and social characteristics in critically ill patients. A cross-sectional study of 78 patients in an adult intensive care unit of a university hospital in Northeastern Brazil was conducted from July to December 2015. Data included social and clinical information and the risk factors of the Braden, Norton and Waterlow scales. Data were analysed by the descriptive and inferential statistics. Most of the participants were female, adults and elderly people with brown skin colour, low education levels and insufficient income. Most of them showed a high risk for developing pressure ulcers using the three evaluated scales. Age, smoking status, diabetes and hypertension were associated with scores on the Waterlow, Braden and Norton scales. Age, use of the tobacco, diabetes and hypertension were associated with the risk of pressure ulcers in ICU patients.

Exploring the Unmet Needs of the Patient in the Outpatient Respiratory Medical Clinic

DEFF Research Database (Denmark)

Jensen, Lone Birgitte; Brinkkjær, Ulf; Larsen, Kristian

2015-01-01

Aim. Developing a theoretical framework explaining patients’ behaviour and actions related to unmet needs during interactions with health care professionals in hospital-based outpatient respiratory medical clinics. Background. The outpatient respiratory medical clinic plays a prominent role in many...... patients’ lives regarding treatment and counselling increasing the need for a better understanding of patients’ perspective to the counselling of the health care professionals. Design. The study is exploratory and based on Charmaz’s interpretation of grounded theory. Methods. The study included 65 field...... observations with a sample of 43 patients, 11 doctors, and 11 nurses, as well as 30 interviews with patients, conducted through theoretical sampling from three outpatient respiratory medical clinics in Denmark. Findings. The patients’ efforts to share their significant stories triggered predominantly...

Suicide Risk Response: Enhancing Patient Safety Through Development of Effective Institutional Policies

National Research Council Canada - National Science Library

Bonner, Laura; Felker, Bradford; Chaney, Edmund; Vollen, Karen; Berry, Karen; Revay, Barbara; Simon, Barbara; Kofoed, Lial; Ober, Scott; Worley, Linda

2004-01-01

A suicidal patient requires a prompt, coordinated intervention. In this paper, we describe a process for developing a suicidality policy, which may help clinics develop effective, locally adapted policies...

Dyspnea descriptors developed in Brazil: application in obese patients and in patients with cardiorespiratory diseases.

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Teixeira, Christiane Aires; Rodrigues Júnior, Antonio Luiz; Straccia, Luciana Cristina; Vianna, Elcio Dos Santos Oliveira; Silva, Geruza Alves da; Martinez, José Antônio Baddini

2011-01-01

To develop a set of descriptive terms applied to the sensation of dyspnea (dyspnea descriptors) for use in Brazil and to investigate the usefulness of these descriptors in four distinct clinical conditions that can be accompanied by dyspnea. We collected 111 dyspnea descriptors from 67 patients and 10 health professionals. These descriptors were analyzed and reduced to 15 based on their frequency of use, similarity of meaning, and potential pathophysiological value. Those 15 descriptors were applied in 50 asthma patients, 50 COPD patients, 30 patients with heart failure, and 50 patients with class II or III obesity. The three best descriptors, as selected by the patients, were studied by cluster analysis. Potential associations between the identified clusters and the four clinical conditions were also investigated. The use of this set of descriptors led to a solution with seven clusters, designated sufoco (suffocating), aperto (tight), rápido (rapid), fadiga (fatigue), abafado (stuffy), trabalho/inspiração (work/inhalation), and falta de ar (shortness of breath). Overlapping of descriptors was quite common among the patients, regardless of their clinical condition. Asthma was significantly associated with the sufoco and trabalho/inspiração clusters, whereas COPD and heart failure were associated with the sufoco, trabalho/inspiração, and falta de ar clusters. Obesity was associated only with the falta de ar cluster. In Brazil, patients who are accustomed to perceiving dyspnea employ various descriptors in order to describe the symptom, and these descriptors can be grouped into similar clusters. In our study sample, such clusters showed no usefulness in differentiating among the four clinical conditions evaluated.

Vaginismus Treatment: Clinical Trials Follow Up 241 Patients.

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Pacik, Peter T; Geletta, Simon

2017-06-01

Vaginismus is mostly unknown among clinicians and women. Vaginismus causes women to have fear, anxiety, and pain with penetration attempts. To present a large cohort of patients based on prior published studies approved by an institutional review board and the Food and Drug Administration using a comprehensive multimodal vaginismus treatment program to treat the physical and psychologic manifestations of women with vaginismus and to record successes, failures, and untoward effects of this treatment approach. Assessment of vaginismus included a comprehensive pretreatment questionnaire, the Female Sexual Function Index (FSFI), and consultation. All patients signed a detailed informed consent. Treatment consisted of a multimodal approach including intravaginal injections of onabotulinumtoxinA (Botox) and bupivacaine, progressive dilation under conscious sedation, indwelling dilator, follow-up and support with office visits, phone calls, e-mails, dilation logs, and FSFI reports. Logs noting dilation progression, pain and anxiety scores, time to achieve intercourse, setbacks, and untoward effects. Post-treatment FSFI scores were compared with preprocedure scores. One hundred seventy-one patients (71%) reported having pain-free intercourse at a mean of 5.1 weeks (median = 2.5). Six patients (2.5%) were unable to achieve intercourse within a 1-year period after treatment and 64 patients (26.6%) were lost to follow-up. The change in the overall FSFI score measured at baseline, 3 months, 6 months, and 1 year was statistically significant at the 0.05 level. Three patients developed mild temporary stress incontinence, two patients developed a short period of temporary blurred vision, and one patient developed temporary excessive vaginal dryness. All adverse events resolved by approximately 4 months. One patient required retreatment followed by successful coitus. A multimodal program that treated the physical and psychologic aspects of vaginismus enabled women to achieve

Clinical and laboratory profile of patients with sickle cell anemia

Directory of Open Access Journals (Sweden)

Phelipe Gabriel dos Santos Sant'Ana

Full Text Available Abstract Objective: This study aimed to describe and analyze clinical and laboratory characteristics of patients with sickle cell anemia treated at the Hemominas Foundation, in Divinópolis, Brazil. Furthermore, this study aimed to compare the clinical and laboratory outcomes of the group of patients treated with hydroxyurea with those patients that were not treated with hydroxyurea. Methods: Clinical and laboratorial data were obtained by analyzing medical records of patients with sickle cell anemia. Results: Data from the medical records of 50 patients were analyzed. Most of the patients were female (56%, aged between 20 and 29 years old. Infections, transfusions, cholecystectomy, splenectomy and systemic arterial hypertension were the most common clinical adverse events of the patients. The most frequent cause of hospitalization was painful crisis. The majority of patients had reduced values of hemoglobin and hematocrit (8.55 ± 1.33 g/dL and 25.7 ± 4.4%, respectively and increased fetal hemoglobin levels (12 ± 7%. None of the clinical variables was statistically significant on comparing the two groups of patients. Among hematological variables only hemoglobin and hematocrit levels were statistically different between patients treated with hydroxyurea and untreated patients (p-value = 0.005 and p-value = 0.001, respectively. Conclusion: Sickle cell anemia requires treatment and follow-up by a multiprofessional team. A current therapeutic option is hydroxyurea. This drug reduces complications and improves laboratorial parameters of patients. In this study, the use of the drug increased the hemoglobin and hematocrit levels of patients.

The patient-physician partnership in asthma: real-world observations associated with clinical and patient-reported outcomes.

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Small, M; Vickers, A; Anderson, P; Kay, S

2010-09-01

It is hypothesized that a good partnership between asthma patients and their physicians has a direct and positive influence on the patients' clinical and patient-reported outcomes. Conversely, poor partnership has a detrimental effect on clinical and patient-reported outcomes. This paper uses data from a real-world observational study to define partnership through matched physician and patient data and correlate the quality of partnership with observed clinical and patient-reported outcomes. Data were drawn from Adelphi's Respiratory Disease Specific Programme, a cross-sectional study of consulting patients in five European countries undertaken between June and September 2009. A range of clinical and patient-reported outcomes were observed allowing analysis of the partnership between 2251 asthma patients and their physicians. Analysis demonstrates that the better the partnership between patient and physician, the more likely the patient is to have their asthma condition controlled (PPartnership is also associated with lower impact on lifestyle (Ppartnership is a contributory factor in the improvement of asthma treatment, and patient education may lead to improvement in a patient's ability to contribute to this. Device satisfaction is one of the markers of good partnership.

Undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkship.

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Lee, Hoo-Yeon; Hahm, Myung-Il; Lee, Sang Gyu

2018-04-04

The purpose of this study was to examine undergraduate medical students' perceptions and intentions regarding patient safety during clinical clerkships. Cross-sectional study administered in face-to-face interviews using modified the Medical Student Safety Attitudes and Professionalism Survey (MSSAPS) from three colleges of medicine in Korea. We assessed medical students' perceptions of the cultures ('safety', 'teamwork', and 'error disclosure'), 'behavioural intentions' concerning patient safety issues and 'overall patient safety'. Confirmatory factor analysis and Spearman's correlation analyses was performed. In total, 194(91.9%) of the 211 third-year undergraduate students participated. 78% of medical students reported that the quality of care received by patients was impacted by teamwork during clinical rotations. Regarding error disclosure, positive scores ranged from 10% to 74%. Except for one question asking whether the disclosure of medical errors was an important component of patient safety (74%), the percentages of positive scores for all the other questions were below 20%. 41.2% of medical students have intention to disclose it when they saw a medical error committed by another team member. Many students had difficulty speaking up about medical errors. Error disclosure guidelines and educational efforts aimed at developing sophisticated communication skills are needed. This study may serve as a reference for other institutions planning patient safety education in their curricula. Assessing student perceptions of safety culture can provide clerkship directors and clinical service chiefs with information that enhances the educational environment and promotes patient safety.

Clinical utility and patient considerations in the use of the sitagliptin-metformin combination in Chinese patients

Directory of Open Access Journals (Sweden)

Du Q

2015-02-01

Full Text Available Qiang Du, Yan-Jun Wang, Sheng Yang, Ping HanDepartment of Endocrinology, Shengjing Hospital of China Medical University, Shenyang, Liaoning, People’s Republic of ChinaAbstract: The prevalence of diabetes mellitus (DM continues to increase each year. However, the efficacy of glucose-lowering therapies remains unsatisfactory. Moreover, the clinical characteristics and manifestations of DM in Chinese patients are different from those in Western patients. Thus, it is imperative to develop an optimal treatment protocol for lowering blood glucose levels in Chinese patients with DM. Sitagliptin has been used in People’s Republic of China, and sitagliptin and metformin combination therapy may not alter their individual pharmacokinetics. To date, several clinical trials undertaken to investigate the efficacy of sitagliptin and metformin combination therapy have revealed that it effectively controlled glycated hemoglobin, fasting plasma glucose, and postprandial plasma glucose levels to a greater extent than sitagliptin or metformin alone. In addition, the combined therapy was well tolerated and induced few side effects, which were largely mild. Furthermore, the combined therapy was easy to administer, and the patients receiving this therapy showed good compliance. Therefore, for Chinese patients with type 2 DM, sitagliptin and metformin combination therapy is preferred.Keywords: type 2 diabetes mellitus, sitagliptin, metformin

Global Trends in Alzheimer Disease Clinical Development: Increasing the Probability of Success.

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Sugino, Haruhiko; Watanabe, Akihito; Amada, Naoki; Yamamoto, Miho; Ohgi, Yuta; Kostic, Dusan; Sanchez, Raymond

2015-08-01

Alzheimer disease (AD) is a growing global health and economic issue as elderly populations increase dramatically across the world. Despite the many clinical trials conducted, currently no approved disease-modifying treatment exists. In this commentary, the present status of AD drug development and the grounds for collaborations between government, academia, and industry to accelerate the development of disease-modifying AD therapies are discussed. Official government documents, literature, and news releases were surveyed by MEDLINE and website research. Currently approved anti-AD drugs provide only short-lived symptomatic improvements, which have no effect on the underlying pathogenic mechanisms or progression of the disease. The failure to approve a disease-modifying drug for AD may be because the progression of AD in the patient populations enrolled in clinical studies was too advanced for drugs to demonstrate cognitive and functional improvements. The US Food and Drug Administration and the European Medicines Agency recently published draft guidance for industry which discusses approaches for conducting clinical studies with patients in early AD stages. For successful clinical trials in early-stage AD, however, it will be necessary to identify biomarkers highly correlated with the clinical onset and the longitudinal progress of AD. In addition, because of the high cost and length of clinical AD studies, support in the form of global initiatives and collaborations between government, industry, and academia is needed. In response to this situation, national guidance and international collaborations have been established. Global initiatives are focusing on 2025 as a goal to provide new treatment options, and early signs of success in biomarker and drug development are already emerging. Copyright © 2015 Elsevier HS Journals, Inc. All rights reserved.

SU-F-T-100: Development and Implementation of a Treatment Planning Tracking System Into the Radiation Oncology Clinic

International Nuclear Information System (INIS)

Kabat, C; Cline, K; Li, Y; Ha, C; Stathakis, S

2016-01-01

Purpose: With increasing numbers of cancer patients being diagnosed and the complexity of radiotherapy treatments rising it’s paramount that patient plan development continues to stay fluid within the clinic. In order to maintain a high standard of care and clinical efficiency the establishment of a tracking system for patient plan development allows healthcare providers to view real time plan progression and drive clinical workflow. In addition, it provides statistical datasets which can further identify inefficiencies within the clinic. Methods: An application was developed utilizing Microsoft’s ODBC SQL database engine to track patient plan status throughout the treatment planning process while also managing key factors pertaining to the patient’s treatment. Pertinent information is accessible to staff in many locations, including tracking monitors within dosimetry, the clinic network for both computers and handheld devices, and through email notifications. Plans are initiated with a CT and continually tracked through planning stages until final approval by staff. Patient’s status is dynamically updated by the physicians, dosimetrists, and medical physicists based on the stage of the patient’s plan. Results: Our application has been running over a six month period with all patients being processed through the system. Modifications have been made to allow for new features to be implemented along with additional tracking parameters. Based on in-house feedback, the application has been supportive in streamlining patient plans through the treatment planning process and data has been accumulating to further improve procedures within the clinic. Conclusion: Over time the clinic will continue to track data with this application. As data accumulates the clinic will be able to highlight inefficiencies within the workflow and adapt accordingly. We will add in new features to help support the treatment planning process in the future.

SU-F-T-100: Development and Implementation of a Treatment Planning Tracking System Into the Radiation Oncology Clinic

Energy Technology Data Exchange (ETDEWEB)

Kabat, C; Cline, K; Li, Y; Ha, C; Stathakis, S [University of Texas HSC SA, San Antonio, TX (United States)

2016-06-15

Purpose: With increasing numbers of cancer patients being diagnosed and the complexity of radiotherapy treatments rising it’s paramount that patient plan development continues to stay fluid within the clinic. In order to maintain a high standard of care and clinical efficiency the establishment of a tracking system for patient plan development allows healthcare providers to view real time plan progression and drive clinical workflow. In addition, it provides statistical datasets which can further identify inefficiencies within the clinic. Methods: An application was developed utilizing Microsoft’s ODBC SQL database engine to track patient plan status throughout the treatment planning process while also managing key factors pertaining to the patient’s treatment. Pertinent information is accessible to staff in many locations, including tracking monitors within dosimetry, the clinic network for both computers and handheld devices, and through email notifications. Plans are initiated with a CT and continually tracked through planning stages until final approval by staff. Patient’s status is dynamically updated by the physicians, dosimetrists, and medical physicists based on the stage of the patient’s plan. Results: Our application has been running over a six month period with all patients being processed through the system. Modifications have been made to allow for new features to be implemented along with additional tracking parameters. Based on in-house feedback, the application has been supportive in streamlining patient plans through the treatment planning process and data has been accumulating to further improve procedures within the clinic. Conclusion: Over time the clinic will continue to track data with this application. As data accumulates the clinic will be able to highlight inefficiencies within the workflow and adapt accordingly. We will add in new features to help support the treatment planning process in the future.

The effects of Clinical Pilates exercises on patients with shoulder pain: A randomised clinical trial.

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Atılgan, Esra; Aytar, Aydan; Çağlar, Aslıcan; Tığlı, Ayça Aytar; Arın, Gamze; Yapalı, Gökmen; Kısacık, Pınar; Berberoğlu, Utku; Şener, Hülya Özlem; Ünal, Edibe

2017-10-01

The purpose of this study was to determine the effect of Clinical Pilates exercises on patients with shoulder pain. Thirty-three patients, experiencing shoulder pain continuously for at least four weeks were selected as study subjects. The patients were randomly divided into two groups, namely Clinical Pilates exercise (n = 17) group and conventional exercise (n = 16) group. The patients were treated for five days a week, the total treatment being carried out for 10 days. The assessment of pain and disability amongst the patients were done at the baseline and at the end of the treatment sessions, using Visual Analogue Scale (VAS) and Shoulder Pain and Disability Index (SPADI). The clinical Pilates exercise group showed a significant improvement in all scores used for assessment (p Pilates exercise group (p Pilates exercise is an efficient technique for patients experiencing shoulder pain, as it helps reduce pain and disability among them. Copyright © 2017 Elsevier Ltd. All rights reserved.

Developing a "clinical presentation" curriculum at the University of Calgary.

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Mandin, H; Harasym, P; Eagle, C; Watanabe, M

1995-03-01

Currently, medical curricula are structured according to disciplines, body systems, or clinical problems. Beginning in 1988, the faculty of the University of Calgary Faculty of Medicine (U of C) carefully evaluated the advantages and disadvantages of each of these models in seeking to revise their school's curriculum. However, all three models fell short of a curricular structure based on current knowledge and principles of adult learning, clinical problem solving, community demands, and curriculum management. By 1991, the U of C had formulated a strategic plan for a revised curriculum structure based on the way patients present to physicians, and implementation of this plan has begun. In creating the new curriculum, 120 clinical presentations (e.g., "loss of consciousness/syncope") were defined and each was assigned to an individual or small group of faculty for development based on faculty expertise and interest. Terminal objectives (i.e., "what to do") were defined for each presentation to describe the appropriate clinical behaviors of a graduating physician. Experts developed schemes that outlined how they differentiated one cause (i.e., disease category) from another. The underlying enabling objectives (i.e., knowledge, skills, and attitudes) for reaching the terminal objectives for each clinical presentation were assigned as departmental responsibilities. A new administrative structure evolved in which there is a partnership between a centralized multidisciplinary curriculum committee and the departments. This new competency-based, clinical presentation curriculum is expected to significantly enhance students' development of clinical problem-solving skills and affirms the premise that prudent, continuous updating is essential for improving the quality of medical education.

Outreach visits by clinical pharmacists improve screening for the metabolic syndrome among mentally ill patients

DEFF Research Database (Denmark)

Kjeldsen, Lene Juel; Hansen, Per Sveistrup; Kristensen, Anne Mette Fisker

2013-01-01

by clinical pharmacists to support the implementation of screening of MeS at a psychiatric ward. Methods: The study was conducted at the psychiatric ward, Odense University Hospital. In 2008, clinical guidelines for systematic screening and prevention of metabolic risk were developed and implemented...... by passive dissemination (PD) followed by a period of active implementation (AI). AI contained outreach visits by clinical pharmacists on a weekly basis. Patients with affective disorder or schizophrenia were included. The study was designed as a before-and-after study, and electronic patient charts were...... pharmacists significantly improved the use of the screening sheet...

Epidemiological and clinical characteristics of Reiter's syndrome in Jordanian patients

International Nuclear Information System (INIS)

Al-Mrayat, Z.; Abdallat, S.; Marabha, T.

2004-01-01

Objective: To study the epidemiological and clinical features of Reiter's syndrome in patients who visited the rheumatology clinic in King Hussein Medical Centre (KHMC), Jordan. Methods: A prospective study, including 43 patients with the diagnosis of Reiter's syndrome was done. Patients were assessed by taking complete history, physical examination and appropriate investigations including urinalysis and culture, stool examination and culture, synovial fluid analysis, complement fixation test for Chlamydia trachomatis, complete blood count, erythrocyte sedimentation rate, rheumatoid factor, antinuclear antibodies. HLA-B27 and radiological study. Results: All patients in this study were white men, with mean age of 26.3 years. HLA-B27 was positive in 37 patients (86%). Most cases were post venereal (32 patients, 74%) while the rest were dysenteric. The clinical manifestations were arthritis in all patients (100%), urethritis in 21 patients (48%), ocular involvement in 20 patients (46%), diarrhea in 12 patients (28%), painless oral ulcers in 11 patients (26%), skin lesions in 5 patients (12%) and constitutional symptoms in 7 patients (16%). Arthritis was mostly oligoarticular (25 patients, 58%) with asymmetrical pattern in 34 patients (78%). Large joints of lower extremity were most involved (29 patients, 68%). Rheumatoid factor and antinuclear antibodies were negative in all patients. Relapses occurred in 7 patients (16%) after a mean period of 6.2 months. Conclusion: It is concluded that the epidemiological and clinical features of Reiter's syndrome in Jordan are not different from those in the literature. (author)

Prevalence and clinical outcomes of hepatitis B virus infection in patients with aplastic anemia.

Science.gov (United States)

Zhao, Pan; Gao, Qing; He, Qiulian; Tan, Jing

2017-10-01

The association of HBV infection with other hematopoietic diseases has been discussed previously. However, the clinical significance and clinical outcomes of HBV infection in AA patients have not been clarified. In this study, we sought to investigate the prevalence and related events of HBV in patients with AA who received immunosuppressive therapy. We retrospectively analyzed 245 patients with acquired AA. The HBsAg positivity rate was 14.69% in this group of AA patients. No significant difference was observed in the severity of AA patients with HBV infection and in those without (P = 0.6358). HBV reactivation occurred in 4.76% of HBsAg-positive patients who received ATG/ALG + CsA treatment without anti-viral prophylaxis. HBV-infected patients who received CsA alone did not develop reactivation. Patients with HBV reactivation showed favorable clinical outcomes, with no HBV-related deaths. There was no significant difference in overall probability of survival in patients with different HBV infection status (P = 0.8617). Given the low rate of reactivation and favorable outcomes after reactivation in AA patients, close monitoring of HBV DNA, hepatic function and patient immune status may be a more effective approach than routine prophylaxis for AA patients with HBV infection undergoing ATG/ALG + CsA treatment. Further studies are warranted to clarify the optimal time to initiate anti-viral treatment.

Clinical decision-making: predictors of patient participation in nursing care.

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Florin, Jan; Ehrenberg, Anna; Ehnfors, Margareta

2008-11-01

To investigate predictors of patients' preferences for participation in clinical decision-making in inpatient nursing care. Patient participation in decision-making in nursing care is regarded as a prerequisite for good clinical practice regarding the person's autonomy and integrity. A cross-sectional survey of 428 persons, newly discharged from inpatient care. The survey was conducted using the Control Preference Scale. Multiple logistic regression analysis was used for testing the association of patient characteristics with preferences for participation. Patients, in general, preferred adopting a passive role. However, predictors for adopting an active participatory role were the patient's gender (odds ratio = 1.8), education (odds ratio = 2.2), living condition (odds ratio = 1.8) and occupational status (odds ratio = 2.0). A probability of 53% was estimated, which female senior citizens with at least a high school degree and who lived alone would prefer an active role in clinical decision-making. At the same time, a working cohabiting male with less than a high school degree had a probability of 8% for active participation in clinical decision making in nursing care. Patient preferences for participation differed considerably and are best elicited by assessment of the individual patient. Relevance to clinical practice. The nurses have a professional responsibility to act in such a way that patients can participate and make decisions according to their own values from an informed position. Access to knowledge of patients'basic assumptions and preferences for participation is of great value for nurses in the care process. There is a need for nurses to use structured methods and tools for eliciting individual patient preferences regarding participation in clinical decision-making.

Acute porphyrias: clinical spectrum of hodpitalized patients

International Nuclear Information System (INIS)

Sheerani, M.; Urfy, M.Z.; Shahid, B.; Hassan, A.

2007-01-01

To determine characteristics, clinical features and triggers of acute porphyria in hospitalized patients presenting to a tertiary care center in Pakistan. Case records of 26 patients hospitalized with diagnosis were identified through computerized hospital patients data. The diagnosis of acute porphyria was based on pertinent clinical features and laboratory investigations after exclusion of other alternative diagnosis and patients previously diagnosed as porphyric. The data was analyzed through SPSS software version 11.0. Twelve patients (46.2%) were males. Mean age was 21 years. Most common manifestation were gastrointestinal (n=22; 88.5%) followed by neurological symptoms (n=14; 54%). Neurological manifestations included seizures (n=9; 34.6%) and neuropathy (n=6; 23%). One patient presented with depression and insomnia. Family history was positive in (n=8; 30.8%). Eighteen (69%) had history of previous attacks at their presentation to the hospital. Most common precipitating factor was eating outside (n=18; 69%). Porphyrias are uncommon and cryptic group of diseases. This study shows a slightly different gender distribution, earlier onset of symptoms, higher number of neuropsychiatric symptoms (especially seizures), more distal neuropathies and different precipitant in the studied subset of patients than described previously in the western studies. (author)

Clinical Orofacial Examination in Juvenile Idiopathic Arthritis: International Consensus-based Recommendations for Monitoring Patients in Clinical Practice and Research Studies.

Science.gov (United States)

Stoustrup, Peter; Twilt, Marinka; Spiegel, Lynn; Kristensen, Kasper Dahl; Koos, Bernd; Pedersen, Thomas Klit; Küseler, Annelise; Cron, Randy Q; Abramowicz, Shelly; Verna, Carlalberta; Peltomäki, Timo; Alstergren, Per; Petty, Ross; Ringold, Sarah; Nørholt, Sven Erik; Saurenmann, Rotraud K; Herlin, Troels

2017-03-01

To develop international consensus-based recommendations for the orofacial examination of patients with juvenile idiopathic arthritis (JIA), for use in clinical practice and research. Using a sequential phased approach, a multidisciplinary task force developed and evaluated a set of recommendations for the orofacial examination of patients with JIA. Phase 1: A Delphi survey was conducted among 40 expert physicians and dentists with the aim of identifying and ranking the importance of items for inclusion. Phase 2: The task force developed consensus about the domains and items to be included in the recommendations. Phase 3: A systematic literature review was performed to assess the evidence supporting the consensus-based recommendations. Phase 4: An independent group of orofacial and JIA experts were invited to assess the content validity of the task force's recommendations. Five recommendations were developed to assess the following 5 domains: medical history, orofacial symptoms, muscle and temporomandibular joint function, orofacial function, and dentofacial growth. After application of data search criteria, 56 articles were included in the systematic review. The level of evidence for the 5 recommendations was derived primarily from descriptive studies, such as cross-sectional and case-control studies. Five recommendations are proposed for the orofacial examination of patients with JIA to improve the clinical practice and aid standardized data collection for future studies. The task force has formulated a future research program based on the proposed recommendations.

Clinical outcome of high-dose-rate interstitial brachytherapy in patients with oral cavity cancer

International Nuclear Information System (INIS)

Lee, Sung Uk; Cho, Kwan Ho; Moon, Sung Ho; Choi, Sung Weon; Park, Joo Yong; Yun, Tak; Lee, Sang Hyun; Lim, Young Kyung; Jeong, Chi Young

2014-01-01

To evaluate the clinical outcome of high-dose-rate (HDR) interstitial brachytherapy (IBT) in patients with oral cavity cancer. Sixteen patients with oral cavity cancer treated with HDR remote-control afterloading brachytherapy using 192Ir between 2001 and 2013 were analyzed retrospectively. Brachytherapy was administered in 11 patients as the primary treatment and in five patients as salvage treatment for recurrence after the initial surgery. In 12 patients, external beam radiotherapy (50-55 Gy/25 fractions) was combined with IBT of 21 Gy/7 fractions. In addition, IBT was administered as the sole treatment in three patients with a total dose of 50 Gy/10 fractions and as postoperative adjuvant treatment in one patient with a total of 35 Gy/7 fractions. The 5-year overall survival of the entire group was 70%. The actuarial local control rate after 3 years was 84%. All five recurrent cases after initial surgery were successfully salvaged using IBT +/- external beam radiotherapy. Two patients developed local recurrence at 3 and 5 months, respectively, after IBT. The acute complications were acceptable (< or =grade 2). Three patients developed major late complications, such as radio-osteonecrosis, in which one patient was treated by conservative therapy and two required surgical intervention. HDR IBT for oral cavity cancer was effective and acceptable in diverse clinical settings, such as in the cases of primary or salvage treatment.

Using standardized patients versus video cases for representing clinical problems in problem-based learning.

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Yoon, Bo Young; Choi, Ikseon; Choi, Seokjin; Kim, Tae-Hee; Roh, Hyerin; Rhee, Byoung Doo; Lee, Jong-Tae

2016-06-01

The quality of problem representation is critical for developing students' problem-solving abilities in problem-based learning (PBL). This study investigates preclinical students' experience with standardized patients (SPs) as a problem representation method compared to using video cases in PBL. A cohort of 99 second-year preclinical students from Inje University College of Medicine (IUCM) responded to a Likert scale questionnaire on their learning experiences after they had experienced both video cases and SPs in PBL. The questionnaire consisted of 14 items with eight subcategories: problem identification, hypothesis generation, motivation, collaborative learning, reflective thinking, authenticity, patient-doctor communication, and attitude toward patients. The results reveal that using SPs led to the preclinical students having significantly positive experiences in boosting patient-doctor communication skills; the perceived authenticity of their clinical situations; development of proper attitudes toward patients; and motivation, reflective thinking, and collaborative learning when compared to using video cases. The SPs also provided more challenges than the video cases during problem identification and hypotheses generation. SPs are more effective than video cases in delivering higher levels of authenticity in clinical problems for PBL. The interaction with SPs engages preclinical students in deeper thinking and discussion; growth of communication skills; development of proper attitudes toward patients; and motivation. Considering the higher cost of SPs compared with video cases, SPs could be used most advantageously during the preclinical period in the IUCM curriculum.

The clinical benefits of antiretroviral therapy in severely immunocompromised HIV-1-infected patients with and without complete viral suppression

DEFF Research Database (Denmark)

Mocroft, Amanda; Bannister, Wendy P; Kirk, Ole

2012-01-01

The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression.......The aim of this study was to determine whether there is a protective effect of combination antiretroviral therapy (cART) on the development of clinical events in patients with ongoing severe immunosuppression....

Development of a Simple Clinical Risk Score for Early Prediction of Severe Dengue in Adult Patients.

Directory of Open Access Journals (Sweden)

Ing-Kit Lee

Full Text Available We aimed to develop and validate a risk score to aid in the early identification of laboratory-confirmed dengue patients at high risk of severe dengue (SD (i.e. severe plasma leakage with shock or respiratory distress, or severe bleeding or organ impairment. We retrospectively analyzed data of 1184 non-SD patients at hospital presentation and 69 SD patients before SD onset. We fit a logistic regression model using 85% of the population and converted the model coefficients to a numeric risk score. Subsequently, we validated the score using the remaining 15% of patients. Using the derivation cohort, two scoring algorithms for predicting SD were developed: models 1 (dengue illness ≤4 days and 2 (dengue illness >4 days. In model 1, we identified four variables: age ≥65 years, minor gastrointestinal bleeding, leukocytosis, and platelet count ≥100×109 cells/L. Model 1 (ranging from -2 to +6 points showed good discrimination between SD and non-SD, with an area under the receiver operating characteristic curve (AUC of 0.848 (95% confidence interval [CI], 0.771-0.924. The optimal cutoff value for model 1 was 1 point, with a sensitivity and specificity for predicting SD of 70.3% and 90.6%, respectively. In model 2 (ranging from 0 to +3 points, significant predictors were age ≥65 years and leukocytosis. Model 2 showed an AUC of 0.859 (95% CI, 0.756-0.963, with an optimal cutoff value of 1 point (sensitivity, 80.3%; specificity, 85.8%. The median interval from hospital presentation to SD was 1 day. This finding underscores the importance of close monitoring, timely resuscitation of shock including intravenous fluid adjustment and early correction of dengue-related complications to prevent the progressive dengue severity. In the validation data, AUCs of 0.904 (95% CI, 0.825-0.983 and 0.917 (95% CI, 0.833-1.0 in models 1 and 2, respectively, were achieved. The observed SD rates (in both cohorts were 50% for those with a score of ≥2 points

High-resolution mutational profiling suggests the genetic validity of glioblastoma patient-derived pre-clinical models.

Directory of Open Access Journals (Sweden)

Shawn E Yost

Full Text Available Recent advances in the ability to efficiently characterize tumor genomes is enabling targeted drug development, which requires rigorous biomarker-based patient selection to increase effectiveness. Consequently, representative DNA biomarkers become equally important in pre-clinical studies. However, it is still unclear how well these markers are maintained between the primary tumor and the patient-derived tumor models. Here, we report the comprehensive identification of somatic coding mutations and copy number aberrations in four glioblastoma (GBM primary tumors and their matched pre-clinical models: serum-free neurospheres, adherent cell cultures, and mouse xenografts. We developed innovative methods to improve the data quality and allow a strict comparison of matched tumor samples. Our analysis identifies known GBM mutations altering PTEN and TP53 genes, and new actionable mutations such as the loss of PIK3R1, and reveals clear patient-to-patient differences. In contrast, for each patient, we do not observe any significant remodeling of the mutational profile between primary to model tumors and the few discrepancies can be attributed to stochastic errors or differences in sample purity. Similarly, we observe ∼96% primary-to-model concordance in copy number calls in the high-cellularity samples. In contrast to previous reports based on gene expression profiles, we do not observe significant differences at the DNA level between in vitro compared to in vivo models. This study suggests, at a remarkable resolution, the genome-wide conservation of a patient's tumor genetics in various pre-clinical models, and therefore supports their use for the development and testing of personalized targeted therapies.

Transparency and public accessibility of clinical trial information in Croatia: how it affects patient participation in clinical trials.

Science.gov (United States)

Šolić, Ivana; Stipčić, Ana; Pavličević, Ivančica; Marušić, Ana

2017-06-15

Despite increased visibility of clinical trials through international trial registries, patients often remain uninformed of their existence, especially if they do not have access to adequate information about clinical research, including the language of the information. The aim of this study was to describe the context for transparency of clinical trials in Croatia in relation to countries in Central and Eastern Europe, and to assess how informed Croatian patients are about clinical trials and their accessibility. We assessed the transparency of clinical trials from the data available in the public domain. We also conducted an anonymous survey on a convenience sample of 257 patients visiting two family medicine offices or an oncology department in south Croatia, and members of national patients' associations. Despite legal provisions for transparency of clinical trials in Croatia, they are still not sufficiently visible in the public domain. Among countries from Central and Eastern Europe, Croatia has the fewest number of registered trials in the EU Clinical Trials Registry. 66% of the patients in the survey were aware of the existence of clinical trials but only 15% were informed about possibilities of participating in a trial. Although 58% of the respondents were willing to try new treatments, only 6% actually participated in a clinical trial. Only 2% of the respondents were aware of publicly available trial registries. Our study demonstrates that there is low transparency of clinical trials in Croatia, and that Croatian patients are not fully aware of clinical trials and the possibilities of participating in them, despite reported availability of Internet resources and good communication with their physicians. There is a need for active policy measures to increase the awareness of and access to clinical trials to patients in Croatia, particularly in their own language.

Low heart rate variability in patients with clinical burnout.

Science.gov (United States)

Lennartsson, Anna-Karin; Jonsdottir, Ingibjörg; Sjörs, Anna

2016-12-01

Several studies have shown that acute psychosocial stress and chronic psychosocial stress reduce heart rate variability (HRV). It is likely that individuals suffering from burnout have reduced HRV, as a consequence of the long-term stress exposure. This study investigated HRV in 54 patients with clinical burnout (40 women and 14 men) and in 55 individuals reporting low burnout scores (healthy; 24 women and 31 men) and 52 individuals reporting high burnout scores (non-clinical burnout; 33 women and 19 men). The participants underwent a 300s ECG recording in the supine position. Standard deviation of normal R-R intervals (SDNN) and the root mean square of successive normal interval differences (RMSSD) were derived from time domain HRV analysis. Frequency domain HRV measures; total power (TP), low frequency power (LF), high frequency power (HF), and LF/HF ratio were calculated. All HRV measures, except LF/HF ratio, were lower in the clinical burnout patients compared to both the non-clinical burnout group and the healthy group. The difference was larger between the patients and the healthy group than between the patients and the non-clinical burnout group. HRV did not differ significantly between the non-clinical burnout group and the healthy group. Low HRV in burnout patients may constitute one of the links to associated adverse health, since low HRV reflects low parasympathetic activity - and accordingly low anabolic/regenerative activity. Copyright © 2016 Elsevier B.V. All rights reserved.

Prosthetic considerations for orthodontic implant site development in the adult patient.

Science.gov (United States)

Holst, Alexandra I; Nkenke, Emeka; Blatz, Markus B; Geiselhöringer, Hans; Holst, Stefan

2009-11-01

Proper site development is a key factor for long-term clinical success of dental implants. Whereas surgical and restorative techniques have been refined to ensure predictable functional and esthetic outcome, individual clinical prerequisites do not always allow proper placement of implants when prosthetic and material properties are considered. Orthodontic tooth movement may be a viable and nonsurgical site development treatment option. With the introduction and advancements of minimal invasive and less visible orthodontic appliances, a growing number of adult patients are willing to obtain orthodontic treatment. The spectrum of modern appliances is broad and ranges from clear aligners to lingual brackets. Skeletal anchorage devices such as orthodontic mini-implants often eliminate unpopular external anchorage devices (ie, headgear) in adult patients, This article discusses the selection of an appropriate pretreatment approach by taking patient-specific criteria into account.

Enrichment methods to detect bone marrow micrometastases in breast carcinoma patients: clinical relevance

International Nuclear Information System (INIS)

Choesmel, Valérie; Pierga, Jean-Yves; Nos, Claude; Vincent-Salomon, Anne; Sigal-Zafrani, Brigitte; Thiery, Jean-Paul; Blin, Nathalie

2004-01-01

Improving technologies for the detection and purification of bone marrow (BM) micrometastatic cells in breast cancer patients should lead to earlier prognosis of the risk of relapse and should make it possible to design more appropriate therapies. The technique used has to overcome the challenges resulting from the small number of target cells (one per million hematopoietic cells) and the heterogeneous expression of micrometastatic cell markers. In the present study, we have assessed the clinical relevance of current methods aimed at detecting rare disseminated carcinoma cells. BM aspirates from 32 carcinoma patients were screened for the presence of micrometastatic cells positive for epithelial cell adhesion molecule and positive for cytokeratins, using optimized immunodetection methods. A comparison with data obtained for 46 control BM aspirates and a correlation with the clinical status of patients were performed. We developed a sensitive and efficient immunomagnetic protocol for the enrichment of BM micrometastases. This method was used to divide 32 breast carcinoma patients into three categories according to their epithelial cell adhesion molecule status. These categories were highly correlated with the recently revised American Joint Committee on Cancer staging system for breast cancer, demonstrating the clinical relevance of this simple and reliable immunomagnetic technique. We also evaluated immunocytochemical detection of cytokeratin-positive cells and cytomorphological parameters. Immunocytochemistry-based methods for the detection of BM micrometastases did not provide any information about the clinical status of patients, but helped to refine the immunomagnetic data by confirming the presence of micrometastases in some cases. We also tested a new density gradient centrifugation system, able to enrich the tumor fraction of BM specimens by twofold to threefold as compared with standard Ficoll methods. These improved methods for the detection of

Development of the clinic of pulmonology and allergy.

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Dokic, D

2013-01-01

University Pulmology and Allergy Clinic was founded in 1975 when the Depertment of Internal Medicine, directed by Prof. Dr. Dimitar Arsov, later member of the Macedonian Academy of Sciencies and Arts, was divided into eight separate and independent clinics. The first head of the Pulmonology and Allergy Clinic was Prof. Dr. Ljubomir Kotevski. He had a very difficult goal: to establish and further develop the newly formed clinic. The Clinic flourished and became one of the leading Clinics in the Clinical Centre during the directorship of Prof. dr. Dejan Dokic.. He completely rebuilt and refurbished the Clinic, which became a modern Clinic providing excellent working conditions for the employees and, most importantly, provided a first class service to the patients. During his mandate he obtained a grant from the Japanese Government worth $1,000,000 which was used to obtain a new, modern and sophisticated medical equipment. Since the establishment of the clinic, many national and international scientific projects were carried out and many scientific papers were published as well as many monographs, and chapters in scientific books. As a result of continuous education, of the total number of 24 doctors there are 16 subspecialists in respiratory medicine and 4 specialists in internal medicine. There are 9 professors in internal medicine at the University of Pulmonology and Allergy Clinic lecturing at the Medical Faculty in Skopje. The University Pulmonology and Allergy Clinic has an international reputation due to many contacts with famous European Institutions. All these international interrelations have resulted in honouring 3 professors: Prof. Dr. Gert Kunkel from Berlin, Germany, Prof. Dr. Robert Loddenkemper from Berlin, Germany and Prof. Dr. Peter Howard from Southampton, UK.

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

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

2016-09-19

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

Pairing students in clinical assignments to develop collaboration and communication skills.

Science.gov (United States)

Bartges, Mali

2012-01-01

Skillful collaboration and communication among healthcare team members are associated with favorable patient outcomes. Student nurses need opportunities for supervised development of these crucial and intertwined skills. The author describes the implementation of a practice-change project for simultaneously developing collaboration and communication skills by pairing prelicensure student nurses in clinical assignments. This easily adapted strategy increases options for faculty looking to stimulate student acquisition of these professional skills.

Clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital

OpenAIRE

Qureshi, Fawad; Shafi, Azhar; Ali, Sheeraz; Siddiqui, Neelam

2016-01-01

Objective: To determine the clinical predictors of anticipatory emesis in patients treated with chemotherapy at a tertiary care cancer hospital. Methods: This was a cross-sectional study conducted on 200 patients undergoing first line chemotherapy with minimum of two cycles at inpatient department and chemotherapy bay of Shaukat Khanum Memorial Cancer Hospital and Research Centre Pakistan. Anticipatory nausea and vomiting develops before administration of chemotherapy. Clinical signs and symp...

Clinical outcome of protein-energy malnourished patients in a Brazilian university hospital

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Pasquini, T.A.S. [Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Uberlândia, Uberlândia, MG (Brazil); Neder, H.D. [Instituto de Economia, Universidade Federal de Uberlândia, Uberlândia, MG (Brazil); Araújo-Junqueira, L. [Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Uberlândia, Uberlândia, MG (Brazil); De-Souza, D.A. [Programa de Pós-Graduação em Ciências da Saúde, Faculdade de Medicina, Universidade Federal de Uberlândia, Uberlândia, MG (Brazil); Departamento de Clínica Médica e Curso de Nutrição, Faculdade de Medicina, Universidade Federal de Uberlândia, Uberlândia, MG (Brazil)

2012-12-17

Protein-energy malnutrition (PEM) is a treatable disease with high prevalence among hospitalized patients. It can cause significant increases in the duration of hospitalization and costs. PEM is especially important for health systems since malnourished patients present higher morbidity and mortality. The objective of the present study was to assess the evolution of nutritional status (NS) and the effect of malnutrition on clinical outcome of patients at a public university hospital of high complexity in Brazil. Patients hospitalized in internal medicine (n = 54), oncology (n = 43), and infectious diseases (n = 12) wards were included. NS was evaluated using subjective global assessment up to 48 h after admission, and thereafter at intervals of 4-6 days. On admission, patients (n = 109) were classified as well-nourished (n = 73), moderately malnourished or at risk of malnutrition (n = 28), and severely malnourished (n = 8). During hospitalization, malnutrition developed or worsened in 11 patients. Malnutrition was included in the clinical diagnosis of only 5/36 records (13.9% of the cases, P = 0.000). Nutritional therapy was administered to only 22/36 of the malnourished patients; however, unexpectedly, 6/73 well-nourished patients also received commercial enteral diets. Complications were diagnosed in 28/36 malnourished and 9/73 well-nourished patients (P = 0.000). Death occurred in 12/36 malnourished and 3/73 well-nourished patients (P = 0.001). A total of 24/36 malnourished patients were discharged regardless of NS. In summary, malnutrition remains a real problem, often unrecognized, unappreciated, and only sporadically treated, even though its effects can be detrimental to the clinical course and prognosis of patients. The amount of public and private funds unnecessarily dispersed because of hospital malnutrition is significant.

Clinical outcome of protein-energy malnourished patients in a Brazilian university hospital

International Nuclear Information System (INIS)

Pasquini, T.A.S.; Neder, H.D.; Araújo-Junqueira, L.; De-Souza, D.A.

2012-01-01

Protein-energy malnutrition (PEM) is a treatable disease with high prevalence among hospitalized patients. It can cause significant increases in the duration of hospitalization and costs. PEM is especially important for health systems since malnourished patients present higher morbidity and mortality. The objective of the present study was to assess the evolution of nutritional status (NS) and the effect of malnutrition on clinical outcome of patients at a public university hospital of high complexity in Brazil. Patients hospitalized in internal medicine (n = 54), oncology (n = 43), and infectious diseases (n = 12) wards were included. NS was evaluated using subjective global assessment up to 48 h after admission, and thereafter at intervals of 4-6 days. On admission, patients (n = 109) were classified as well-nourished (n = 73), moderately malnourished or at risk of malnutrition (n = 28), and severely malnourished (n = 8). During hospitalization, malnutrition developed or worsened in 11 patients. Malnutrition was included in the clinical diagnosis of only 5/36 records (13.9% of the cases, P = 0.000). Nutritional therapy was administered to only 22/36 of the malnourished patients; however, unexpectedly, 6/73 well-nourished patients also received commercial enteral diets. Complications were diagnosed in 28/36 malnourished and 9/73 well-nourished patients (P = 0.000). Death occurred in 12/36 malnourished and 3/73 well-nourished patients (P = 0.001). A total of 24/36 malnourished patients were discharged regardless of NS. In summary, malnutrition remains a real problem, often unrecognized, unappreciated, and only sporadically treated, even though its effects can be detrimental to the clinical course and prognosis of patients. The amount of public and private funds unnecessarily dispersed because of hospital malnutrition is significant

Development of a clinical forensic medicine curriculum for emergency physicians in the USA.

Science.gov (United States)

Smock, W S

1994-06-01

To address the forensic needs of living patients, the Department of Emergency Medicine at the University of Louisville School of Medicine in Louisville, Kentucky, USA initiated the first clinical forensic medicine training programme in the USA. In July 1991, formal training in clinical forensic medicine was incorporated into the core curriculum of the USA's second oldest academic emergency medicine training programme. The University of Louisville, in cooperation with the Kentucky Medical Examiner's Office, developed the curriculum to provide the emergency physician with the knowledge base and technical skills to perform forensic evaluations of living patients. Forensic lectures are given monthly by local and regional forensic experts including: forensic pathologists, prosecuting attorneys, firearm and ballistics examiners, law enforcement officers, forensic chemists and forensic odontologists. Topics which are presented include: forensic pathology, forensic photography, ballistics and firearms analysis, paediatric physical and sexual assault, crime scene investigation, forensic odontology, courtroom and expert testimony and the forensic evaluation of penetrating trauma. As a result of the introduction of clinical forensic medicine into the core curriculum of an emergency medicine training programme the residents are now actively addressing the forensic issues encountered in the Emergency department. Key, often short-lived forensic evidence, which was frequently overlooked or discarded while delivering patient care is now recognized, documented and preserved. The development and introduction of a clinical forensic medicine curriculum into emergency medicine training has greatly enhanced the emergency physician's ability to recognize, document and address the forensic needs of their patients who are victims of violent and non-fatal trauma.

Managing patients' wait time in specialist out-patient clinic using real-time data from existing queue management and ADT systems.

Science.gov (United States)

Ju, John Chen; Gan, Soon Ann; Tan Siew Wee, Justine; Huang Yuchi, Peter; Mei Mei, Chan; Wong Mei Mei, Sharon; Fong, Kam Weng

2013-01-01

In major cancer centers, heavy patients load and multiple registration stations could cause significant wait time, and can be result in patient complains. Real-time patient journey data and visual display are useful tools in hospital patient queue management. This paper demonstrates how we capture patient queue data without deploying any tracing devices; and how to convert data into useful patient journey information to understand where interventions are likely to be most effective. During our system development, remarkable effort has been spent on resolving data discrepancy and balancing between accuracy and system performances. A web-based dashboard to display real-time information and a framework for data analysis were also developed to facilitate our clinics' operation. Result shows our system could eliminate more than 95% of data capturing errors and has improved patient wait time data accuracy since it was deployed.

Clinical Characteristics of Patients with Intradialytic Hypertension.

Science.gov (United States)

Eftimovska-Otovic, Natasa; Grozdanovski, Risto; Taneva, Borjanka; Stojceva-Taneva, Olivera

2015-01-01

Intradialytic hypertension with a prevalence of 15% among hemodialysis patients is with unknown pathophysiology, demographic, laboratoiy and clinical characteristic of patients, and it's influence on longtenn clinical effects (cardiovascular morbidity and mortality, rate of hospitalization). The aim of the study is to present the clinical, laboratoiy and demographic characteristics of patients with intradialytic hypertension in our dialysis center. Out of 110 hemodialysis patients, 17 patients (15,45%) had intradialytic hypertension - started at a systolic pressure greater than 140 nun Hg or had an increase in systolic pressure more than 10 mm Hg during the session, and 17 patients were nonnotensive or had a drop in blood pressure dining the dialysis. HD were performed 3 times per week with a duration of 4-5 hours, on machines with controlled ultrafiltration and high flux syntetic membrane (polyetersulfon) sterilized with gamma rays. A dialysate with standard electrolytes content was used (Na(+) 138 mmol/L, K(+) 2,0 mmol/L, Ca(++) 1,5 mmol/L, Mg (+)1,0 mmol/L, CH(3)COO(-) 3,0 mmol/L, Cl -110 mmol/1, HCO(3)(-) 35 mmol/L). We analysed the following demographic and clinical characteristics: gender, age, BMI, dialysis vintage, vascular acces, cardiovascular comorbidity (cardiomyopathy, ischemic cardiac disease, peripheral artery disease, heart valve disease), number and type of antihypertensive drugs, weekly dose of erythropoesis - stimulating agent, standard monthly, three and six months laboratoiy analyzes, and sp Kt/V and PCR. Statistical analysis was performed using the statistical software SPSS 17.0. hi both groups men were predominant (IDH group 88.23%, control group 64.07%). The IDH group was older (59.00 ± 7.64 versus 49.00 ± 13.91, p = 0.314) and with lower BMI (p = 0.246) compared to the control group. The DDH patients had significantly lower serum sodium and higher sodium gradient (135.75 ± 2.03 versus 137.33 ± 1.97, p = 0.042; 2.25 ± 1.98 versus 0.66 �

Clinical software development for the Web: lessons learned from the BOADICEA project.

Science.gov (United States)

Cunningham, Alex P; Antoniou, Antonis C; Easton, Douglas F

2012-04-10

In the past 20 years, society has witnessed the following landmark scientific advances: (i) the sequencing of the human genome, (ii) the distribution of software by the open source movement, and (iii) the invention of the World Wide Web. Together, these advances have provided a new impetus for clinical software development: developers now translate the products of human genomic research into clinical software tools; they use open-source programs to build them; and they use the Web to deliver them. Whilst this open-source component-based approach has undoubtedly made clinical software development easier, clinical software projects are still hampered by problems that traditionally accompany the software process. This study describes the development of the BOADICEA Web Application, a computer program used by clinical geneticists to assess risks to patients with a family history of breast and ovarian cancer. The key challenge of the BOADICEA Web Application project was to deliver a program that was safe, secure and easy for healthcare professionals to use. We focus on the software process, problems faced, and lessons learned. Our key objectives are: (i) to highlight key clinical software development issues; (ii) to demonstrate how software engineering tools and techniques can facilitate clinical software development for the benefit of individuals who lack software engineering expertise; and (iii) to provide a clinical software development case report that can be used as a basis for discussion at the start of future projects. We developed the BOADICEA Web Application using an evolutionary software process. Our approach to Web implementation was conservative and we used conventional software engineering tools and techniques. The principal software development activities were: requirements, design, implementation, testing, documentation and maintenance. The BOADICEA Web Application has now been widely adopted by clinical geneticists and researchers. BOADICEA Web

Medical students' clinical performance of dealing with patients in the context of domestic violence.

Science.gov (United States)

Kong, Hyun-Hee; Im, Sunju; Seo, Ji-Hyun; Kim, Do-Kyong; Roh, HyeRin

2018-03-01

The aim of this study was to inquire about the clinical performance and determine the performance pattern of medical students in standardized patient (SP) based examinations of domestic violence (DV). The clinical performance sores in DV station with SP of third-year (n=111, in 2014) and 4th-year (n=143, in 2016) medical students of five universities in the Busan-Gyeongnam Clinical Skills Examination Consortium were subjected in this study. The scenarios and checklists of DV cases were developed by the case development committee of the consortium. The students' performance was compared with other stations encountered in SP. The items of the checklists were categorized to determine the performance pattern of students investigating DV into six domains: disclosure strategy (D), DV related history taking (H), checking the perpetrator's psychosocial state (P), checking the victim's condition (V), negotiating and persuading the interviewee (N), and providing information about DV (I). Medical students showed poorer performance in DV stations than in the other stations with SP in the same examination. Most students did confirm the perpetrator and commented on confidentiality but ignored the perpetrator's state and patient's physical and psychological condition. The students performed well in the domains of D, H, and I but performed poorly in domains P, V, and N. Medical students showed poor clinical performance in the DV station. They performed an 'event oriented interview' rather than 'patient centered' communication. An integrated educational program of DV should be set to improve students' clinical performance.

Clinical development of Ebola vaccines

Science.gov (United States)

Sridhar, Saranya

2015-01-01

The ongoing outbreak of Ebola virus disease in West Africa highlighted the lack of a licensed drug or vaccine to combat the disease and has renewed the urgency to develop a pipeline of Ebola vaccines. A number of different vaccine platforms are being developed by assessing preclinical efficacy in animal models and expediting clinical development. Over 15 different vaccines are in preclinical development and 8 vaccines are now in different stages of clinical evaluation. These vaccines include DNA vaccines, virus-like particles and viral vectors such as live replicating vesicular stomatitis virus (rVSV), human and chimpanzee adenovirus, and vaccinia virus. Recently, in preliminary results reported from the first phase III trial of an Ebola vaccine, the rVSV-vectored vaccine showed promising efficacy. This review charts this rapidly advancing area of research focusing on vaccines in clinical development and discusses the future opportunities and challenges faced in the licensure and deployment of Ebola vaccines. PMID:26668751

Comparison of mania patients suitable for treatment trials versus clinical treatment.

Science.gov (United States)

Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

Using multimedia virtual patients to enhance the clinical curriculum for medical students.

Science.gov (United States)

McGee, J B; Neill, J; Goldman, L; Casey, E

1998-01-01

Changes in the environment in which clinical medical education takes place in the United States has profoundly affected the quality of the learning experience. A shift to out-patient based care, minimization of hospitalization time, and shrinking clinical revenues has changed the teaching hospital or "classroom" to a degree that we must develop innovative approaches to medical education. One solution is the Virtual Patient Project. Utilizing state-of-the-art computer-based multimedia technology, we are building a library of simulated patient encounters that will serve to fill some of the educational gaps that the current health care system has created. This project is part of a newly formed and unique organization, the Harvard Medical School-Beth Israel Deaconess Mount Auburn Institute for Education and Research (the Institute), which supports in-house educational design, production, and faculty time to create Virtual Patients. These problem-based clinical cases allow the medical student to evaluate a patient at initial presentation, order diagnostic tests, observe the outcome and obtain context-sensitive feedback through a computer program designed at the Institute. Multimedia technology and authoring programs have reached a level of sophistication to allow content experts (the teaching faculty) to design and create the majority of the program themselves and to allow students to adapt the program to their individual learning needs.

[Clinical extraintestinal manifestations in patients with ulcerative colitis].

Science.gov (United States)

Toader, Elena

2007-01-01

Ulcerative colitis (UC) is a chronic disease clinically manifest either by bowel symptoms alone or extraintestinal symptoms. Our prospective study included 635 patients with ulcerative colitis (334 males and 301 females, mean age 37.54 +/- 13.84, range 20-70 years). The presence of the common extraintestinal symptoms (ES) was analyzed. Of the 635 investigated patients, these symptoms were found in 83 (13%, 49 males and 34 females, mean age 41.6 +/- 13.95 range 21-70). Patients with ES suffered longer from UC on the average, that is 60.6 years. Most commonly ES involved the joints, 38 (45.8%) patients, hepatobiliary, 28 patients (33.7%), skin, 10 patients (12%) and eyes, 7 patients (8.4%). In 18% of the patients two or more ES were present. ES were clinically detectable after the intestinal symptoms in 81% patients. An increased tendency of ES to occur in patients with a more extensive disease was noticed. The prevalence of ES in the UC patients from NE Romania is in agreement with data from other countries. The number of ES supports the need for complex follow-up in these patients.

Norrie disease: extraocular clinical manifestations in 56 patients.

Science.gov (United States)

Smith, Sharon E; Mullen, Thomas E; Graham, Dionne; Sims, Katherine B; Rehm, Heidi L

2012-08-01

Norrie disease (ND) is an X-linked recessive disorder characterized by congenital blindness, progressive sensorineural hearing loss and cognitive impairment. The ocular phenotype has been well described, while the extraocular manifestations of the disorder are not well understood. We present the data from the Norrie Disease Registry, which consists of 56 patients with detailed clinical histories and genotype data. This study represents the largest, detailed investigation into the phenotypic spectrum of ND to date and more importantly expands knowledge of the extraocular clinical manifestations. We identify several novel aspects of the syndrome that will improve the management of these patients. In particular, we expand our understanding of the neurologic manifestations in ND and identify a chronic seizure disorder in approximately 10% of all patients. In addition, details of the hearing phenotype are described including the median age of onset (12 years of age) and how genotype affects onset. Moreover, we find vascular disease to be a significant component of ND; and vascular health should be, in the future, a component of patient clinical care. In summary, the results expand our understanding of the phenotypic variability and genotypic heterogeneity in ND patients. Copyright © 2012 Wiley Periodicals, Inc.

Custom software development for use in a clinical laboratory.

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Sinard, John H; Gershkovich, Peter

2012-01-01

In-house software development for use in a clinical laboratory is a controversial issue. Many of the objections raised are based on outdated software development practices, an exaggeration of the risks involved, and an underestimation of the benefits that can be realized. Buy versus build analyses typically do not consider total costs of ownership, and unfortunately decisions are often made by people who are not directly affected by the workflow obstacles or benefits that result from those decisions. We have been developing custom software for clinical use for over a decade, and this article presents our perspective on this practice. A complete analysis of the decision to develop or purchase must ultimately examine how the end result will mesh with the departmental workflow, and custom-developed solutions typically can have the greater positive impact on efficiency and productivity, substantially altering the decision balance sheet. Involving the end-users in preparation of the functional specifications is crucial to the success of the process. A large development team is not needed, and even a single programmer can develop significant solutions. Many of the risks associated with custom development can be mitigated by a well-structured development process, use of open-source tools, and embracing an agile development philosophy. In-house solutions have the significant advantage of being adaptable to changing departmental needs, contributing to efficient and higher quality patient care.

Use of clinical simulations for patient education: targeting an untapped audience.

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Siwe, Karin; Berterö, Carina; Pugh, Carla; Wijma, Barbro

2009-01-01

In most cases, the health professional has been the target for simulation based learning curricula. We have developed a simulation based curriculum for patient education. In our curriculum lay-women learn how to perform the clinical female pelvic examination using a manikin-based trainer. Learner assessments show that prior negative expectations turned into positive expectations regarding future pelvic examinations.

A Clinical Decision Support System for Breast Cancer Patients

Science.gov (United States)

Fernandes, Ana S.; Alves, Pedro; Jarman, Ian H.; Etchells, Terence A.; Fonseca, José M.; Lisboa, Paulo J. G.

This paper proposes a Web clinical decision support system for clinical oncologists and for breast cancer patients making prognostic assessments, using the particular characteristics of the individual patient. This system comprises three different prognostic modelling methodologies: the clinically widely used Nottingham prognostic index (NPI); the Cox regression modelling and a partial logistic artificial neural network with automatic relevance determination (PLANN-ARD). All three models yield a different prognostic index that can be analysed together in order to obtain a more accurate prognostic assessment of the patient. Missing data is incorporated in the mentioned models, a common issue in medical data that was overcome using multiple imputation techniques. Risk group assignments are also provided through a methodology based on regression trees, where Boolean rules can be obtained expressed with patient characteristics.

Risk of complications in coeliac patients depends on age at diagnosis and type of clinical presentation.

Science.gov (United States)

Biagi, Federico; Schiepatti, Annalisa; Maiorano, Gregorio; Fraternale, Giacomo; Agazzi, Simona; Zingone, Fabiana; Ciacci, Carolina; Volta, Umberto; Caio, Giacomo; Tortora, Raffaella; Klersy, Catherine; Corazza, Gino R

2018-06-01

Coeliac disease is characterised by an increased mortality mostly due to its complications. To study the risk of developing complications according to clinical presentation and age at diagnosis, a combined retrospective-prospective longitudinal study was performed in three Italian centres. Incidence of complications and mortality rates were calculated using type and age at diagnosis of coeliac disease, sex, and centre of diagnosis as predictors. Patients referred after being found to suffer from coeliac disease elsewhere were excluded. Between 01/1999 and 06/2015, 2225 adult coeliac patients were directly diagnosed in our centres. 17 of them developed a complication and 29 died. In patients older than 60 years at diagnosis of coeliac disease, the risk of complication is 18 times higher than in patients diagnosed at 18-40 years and 9 times higher than in patients diagnosed at 40-60 years. Classical presentation increases the risk of complications by 7 times compared to non-classical presentation; in asymptomatic patients the risk of complication is virtually absent. The risk of developing complications in coeliac patients is linked to age at diagnosis of coeliac disease and type of clinical presentation. Follow-up methods of coeliac patients should be tailored according to these parameters. Copyright © 2017. Published by Elsevier Ltd.

Epidemiological and Clinical profile of HIV-infected patients ...

African Journals Online (AJOL)

Background: Treatment and care services for HIV patients in Tanzania began 2004 with free access to anti-retroviral therapy (ART). More than 1000 HIV clinics have been established to-date. Each clinic is obliged to provide statistical and clinical feedback for further improvement. Broad objective: The objective of this study ...

Current clinical approach to patients with disorders of consciousness

Directory of Open Access Journals (Sweden)

Robson Luis Oliveira de Amorim

Full Text Available Summary In clinical practice, hospital admission of patients with altered level of consciousness, sleepy or in a non-responsive state is extremely common. This clinical condition requires an effective investigation and early treatment. Performing a focused and objective evaluation is critical, with quality history taking and physical examination capable to locate the lesion and define conducts. Imaging and laboratory exams have played an increasingly important role in supporting clinical research. In this review, the main types of changes in consciousness are discussed as well as the essential points that should be evaluated in the clinical management of these patients.

Free software to analyse the clinical relevance of drug interactions with antiretroviral agents (SIMARV®) in patients with HIV/AIDS.

Science.gov (United States)

Giraldo, N A; Amariles, P; Monsalve, M; Faus, M J

Highly active antiretroviral therapy has extended the expected lifespan of patients with HIV/AIDS. However, the therapeutic benefits of some drugs used simultaneously with highly active antiretroviral therapy may be adversely affected by drug interactions. The goal was to design and develop a free software to facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. A comprehensive Medline/PubMed database search of drug interactions was performed. Articles that recognized any drug interactions in HIV disease were selected. The publications accessed were limited to human studies in English or Spanish, with full texts retrieved. Drug interactions were analyzed, assessed, and grouped into four levels of clinical relevance according to gravity and probability. Software to systematize the information regarding drug interactions and their clinical relevance was designed and developed. Overall, 952 different references were retrieved and 446 selected; in addition, 67 articles were selected from the citation lists of identified articles. A total of 2119 pairs of drug interactions were identified; of this group, 2006 (94.7%) were drug-drug interactions, 1982 (93.5%) had an identified pharmacokinetic mechanism, and 1409 (66.5%) were mediated by enzyme inhibition. In terms of clinical relevance, 1285 (60.6%) drug interactions were clinically significant in patients with HIV (levels 1 and 2). With this information, a software program that facilitates identification and assessment of the clinical relevance of antiretroviral drug interactions (SIMARV ® ) was developed. A free software package with information on 2119 pairs of antiretroviral drug interactions was designed and developed that could facilitate analysis, assessment, and clinical decision making according to the clinical relevance of drug interactions in patients with HIV/AIDS. Copyright © 2016 Elsevier Inc. All rights reserved.

A model to teach concomitant patient communication during psychomotor skill development.

Science.gov (United States)

Nicholls, Delwyn; Sweet, Linda; Muller, Amanda; Hyett, Jon

2018-01-01

Many health professionals use psychomotor or task-based skills in clinical practice that require concomitant communication with a conscious patient. Verbally engaging with the patient requires highly developed verbal communication skills, enabling the delivery of patient-centred care. Historically, priority has been given to learning the psychomotor skills essential to clinical practice. However, there has been a shift towards also ensuring competent communication with the patient during skill performance. While there is literature outlining the steps to teach and learn verbal communication skills, little is known about the most appropriate instructional approach to teach how to verbally engage with the patient when also learning to perform a task. A literature review was performed and it identified that there was no model or proven approach which could be used to integrate the learning of both psychomotor and communication skills. This paper reviews the steps to teach a communication skill and provides a suggested model to guide the acquisition and development of the concomitant -communication skills required with a patient at the time a psychomotor skill is performed. Copyright © 2017 Elsevier Ltd. All rights reserved.

Epidemiological and clinical features of primary liver cancer: an analysis of 236 patients

Directory of Open Access Journals (Sweden)

ZHAO Rongrong

2016-08-01

Full Text Available ObjectiveTo investigate the epidemiological and clinical features of patients with primary liver cancer (PLC. MethodsA retrospective analysis was performed for the clinical data of 236 patients with complete information who were admitted to The First Hospital of Lanzhou University and diagnosed with PLC for the first time form August 2012 to August 2014, and their epidemiological and clinical features were analyzed. The chi-square test was used for comparison of categorical data between groups. ResultsAmong the 236 PLC patients, there were 198 male patients (83.9% and 38 female patients (16.1%, and the patients aged 41-60 years has the highest incidence rate (58.5%, 138/236. Nineteen patients had a family history of liver cancer, 28 had a history of heavy drinking, 34 were complicated by type 2 diabetes, and 44 were complicated by hypertension. Among these patients, 232 (98.3% developed PLC on the basis of chronic liver disease, and 4 (1.7% had no chronic liver disease. There were 207 patients (87.7% with chronic HBV infection, and most of them had HBeAg-negative infection. Fourteen patients (5.9% had chronic HCV infection, 5 (2.1% had HBV/HCV co-infection, and 6 (2.5% had chronic alcoholic hepatitis. Among the 212 patients with HBV infection, 51(241% had HBeAg-positive chronic hepatitis B, and 95(448% had HBeAg-negative chronic hepatitis B; there was significant difference in HBV DNA level between the two groups (χ２＝４０６８７，Ρ＝0001. Among all the PLC patients, 104 had an alpha-fetoprotein(AFP level of ＞400 IU/ml, 48 had an AFP level of 200-400 IU/ml, and 84 had an AFP level of ＜200 IU/ml; 154 (62.3% had a single lesion, and 72 (30.5% had multiple lesions; most (72.7% of patients with a single lesion had the single lesion in the right lobe, and the proportions of patients with multiple lesions in the right lobe and in both lobes accounted for 58.3% and 41.7%, respectively. Among the 80 PLC patients with

Patients' approaches to students' learning at a clinical education ward--an ethnographic study.

Science.gov (United States)

Manninen, Katri; Henriksson, Elisabet Welin; Scheja, Max; Silén, Charlotte

2014-07-02

It is well known that patients' involvement in health care students' learning is essential and gives students opportunities to experience clinical reasoning and practice clinical skills when interacting with patients. Students encounter patients in different contexts throughout their education. However, looking across the research providing evidence about learning related to patient-student encounters reveals a lack of knowledge about the actual learning process that occurs in encounters between patients and students. The aim of this study was to explore patient-student encounters in relation to students' learning in a patient-centered health-care setting. An ethnographic approach was used to study the encounters between patients and students. The setting was a clinical education ward for nursing students at a university hospital with eight beds. The study included 10 observations with 11 students and 10 patients. The observer followed one or two students taking care of one patient. During the fieldwork observational and reflective notes were taken. After each observation follow-up interviews were conducted with each patient and student separately. Data were analyzed using an ethnographic approach. The most striking results showed that patients took different approaches in the encounters with students. When the students managed to create a good atmosphere and a mutual relationship, the patients were active participants in the students' learning. If the students did not manage to create a good atmosphere, the relationship became one-way and the patients were passive participants, letting the students practice on their bodies but without engaging in a dialogue with the students. Patient-student encounters, at a clinical education ward with a patient-centred pedagogical framework, can develop into either a learning relationship or an attending relationship. A learning relationship is based on a mutual relationship between patients and students resulting in patients

Clinical Presentation and Care of Patients with Ebola Virus Disease in the China Ebola Treatment Unit, Liberia.

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Shao, Xiaoping; Ren, Weizheng; Zhou, Feihu

2017-01-24

In order to evaluate the clinical characteristics of confirmed Ebola Virus Disease (EVD) patients admitted to the China Ebola Treatment Unit (China ETU) between January 2015 and March 2015, we retrospectively analyzed clinical symptoms, treatment, and epidemiologic features of 5 patients with confirmed EVD, and reviewed the relevant medical literature. Of these, 3 patients survived, and 2 died. The time interval from the onset of symptoms to the negative PCR test for Ebola virus in the 3 survivors was 14-18 days. All survivors reported direct contact with confirmed EVD patients up to 21 days prior to admission. All patients developed a fever, fatigue, and anorexia. Fever was generally the first symptom to develop, followed by a gastrointestinal phase characterized by vomiting/nausea (3 cases, 60%), diarrhea (3 cases), and abdominal pain (4 cases, 80%). Three patients (60%) reported joint pain, muscle pain, and conjunctival hemorrhage, respectively, and 2 patients (40%) developed a headache. We concluded that strict isolation and interruption of the route of transmission were required for suspected or confirmed EVD patients. The main treatment strategies were supportive care, maintenance of blood volume and electrolyte balance, and the prevention of complications.

Development of clinically relevant implantable pressure sensors: perspectives and challenges.

Science.gov (United States)

Clausen, Ingelin; Glott, Thomas

2014-09-22

This review describes different aspects to consider when developing implantable pressure sensor systems. Measurement of pressure is in general highly important in clinical practice and medical research. Due to the small size, light weight and low energy consumption Micro Electro Mechanical Systems (MEMS) technology represents new possibilities for monitoring of physiological parameters inside the human body. Development of clinical relevant sensors requires close collaboration between technological experts and medical clinicians.  Site of operation, size restrictions, patient safety, and required measurement range and resolution, are only some conditions that must be taken into account. An implantable device has to operate under very hostile conditions. Long-term in vivo pressure measurements are particularly demanding because the pressure sensitive part of the sensor must be in direct or indirect physical contact with the medium for which we want to detect the pressure. New sensor packaging concepts are demanded and must be developed through combined effort between scientists in MEMS technology, material science, and biology. Before launching a new medical device on the market, clinical studies must be performed. Regulatory documents and international standards set the premises for how such studies shall be conducted and reported.

Diagnostic issues, clinical characteristics, and outcomes for patients with fungemia

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

2011-01-01

This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

Diagnostic Issues, Clinical Characteristics, and Outcomes for Patients with Fungemia

DEFF Research Database (Denmark)

Arendrup, Maiken Cavling; Sulim, Sofia; Holm, Anette

2011-01-01

This study investigated microbiological, clinical, and management issues and outcomes for Danish fungemia patients. Isolates and clinical information were collected at six centers. A total of 334 isolates, 316 episodes, and 305 patients were included, corresponding to 2/3 of the national episodes...... needed longer incubation. Species distribution varied by age, prior antifungal treatment (57% occurrence of C. glabrata, Saccharomyces cerevisiae, or C. krusei in patients with prior antifungal treatment versus 28% occurrence in those without it; P = 0.007), and clinical specialty (61% occurrence of C...

A multidisciplinary three-phase approach to improve the clinical utility of patient safety indicators.

Science.gov (United States)

Najjar, Peter; Kachalia, Allen; Sutherland, Tori; Beloff, Jennifer; David-Kasdan, Jo Ann; Bates, David W; Urman, Richard D

2015-01-01

The AHRQ Patient Safety Indicators (PSIs) are used for calculation of risk-adjusted postoperative rates for adverse events. The payers and quality consortiums are increasingly requiring public reporting of hospital performance on these metrics. We discuss processes designed to improve the accuracy and clinical utility of PSI reporting in practice. The study was conducted at a 793-bed tertiary care academic medical center where PSI processes have been aggressively implemented to track patient safety events at discharge. A three-phased approach to improving administrative data quality was implemented. The initiative consisted of clinical review of all PSIs, documentation improvement, and provider outreach including active querying for patient safety events. This multidisciplinary effort to develop a streamlined process for PSI calculation reduced the reporting of miscoded PSIs and increased the clinical utility of PSI monitoring. Over 4 quarters, 4 of 41 (10%) PSI-11 and 9 of 138 (7%) PSI-15 errors were identified on review of clinical documentation and appropriate adjustments were made. A multidisciplinary, phased approach leveraging existing billing infrastructure for robust metric coding, ongoing clinical review, and frontline provider outreach is a novel and effective way to reduce the reporting of false-positive outcomes and improve the clinical utility of PSIs.