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Sample records for clinical evaluation study

  1. Clinical Applications of Evaluation Studies.

    ERIC Educational Resources Information Center

    Brown, Barry S.

    A series of followup investigations exploring the impact of methadone maintenance treatment, methadone detoxification treatment, therapeutic communities, and outpatient drug-free treatment for the drug abuser was conducted. Limitations of these modalities were revealed in the followup studies. Implications for treatment and policy include: (1)…

  2. Evaluation systems for clinical governance development: a comparative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Lack of scientific and confirmed researches and expert knowledge about evaluation systems for clinical governance development in Iran have made studies on different evaluation systems for clinical governance development a necessity. These studies must provide applied strategies to design criteria of implementing clinical governance for hospital's accreditation. This is a descriptive and comparative study on development of clinical governance models all over the world. Data have been gathered by reviewing related articles. Models have been studied in comprehensive review method. The evaluated models of clinical governance development were Australian, NHS, SPOCK and OPTIGOV. The final aspects extracted from these models were Responsiveness, Policies and Strategies, Organizational Structure, Allocating Resources, Education and Occupational Development, Performance Evaluation, External Evaluation, Patient Oriented Approach, Risk Management, Personnel's Participation, Information Technology, Human Resources, Research and Development, Evidence Based Medicine, Clinical Audit, Health Technology Assessment and Quality. These results are applicable for completing the present criteria which evaluating clinical governance application and provide practical framework to evaluate country's hospital on the basis of clinical governance elements.

  3. Clinical evaluation of hypnotic drugs: contributions from sleep laboratory studies.

    PubMed

    Kales, A; Scharf, M B; Soldatos, C R; Bixler, E O

    1979-07-01

    The most thorough and clinically relevant approach to hypnotic drug evaluation is one that balances the strengths and weaknesses of clinical trials and sleep laboratory evaluations. Advantages of clinical trials include the ability to evaluate large numbers of subjects and specific target groups and to thoroughly assess and quantify a drug's side effects, whereas sleep laboratory studies are very limited in all of these areas. Sleep laboratory studies however provide a rigorous, precise, and comprehensive profile of a drug's activity since there is more control over experimental variables and measurements are objective as well as continuous throughout the night. These benefits offset the shortcomings of clinical trials, which include a lack of objective measurements, less control over experimental variables, failure to evaluate a drug's effectiveness with continued use, and inattention to drug interaction and withdrawal effect. Several basic principles derived from sleep laboratory findings have been incorporated into both the clinical trials and sleep laboratory evaluations recommended in the new FDA Guidelines for the Clinical Evaluation of Hypnotic Drugs. These principles include provision for adequate baseline and withdrawal periods, use of multiple consecutive drug nights to assess a drug's effectiveness with continued use, and inclusion of an adequate washout period when a cross-over design is used. The guidelines do not emphasize either clinical trials or sleep laboratory studies at the expense of each other, but rather stress their complementary utilization.

  4. Validation of a virtual preoperative evaluation clinic: a pilot study.

    PubMed

    Zetterman, Corey V; Sweitzer, Bobbie J; Webb, Brad; Barak-Bernhagen, Mary A; Boedeker, Ben H

    2011-01-01

    Patients scheduled for surgery at the Omaha VA Medical Center were evaluated preoperatively via telemedicine. Following the examination, patients filled out a 15 item, 5 point Likert scale questionnaire regarding their opinion of preoperative evaluation in a VTC format. Evaluations were performed under the direction of nationally recognized guidelines and recommendations of experts in the field of perioperative medicine and were overseen by a staff anesthesiologist from the Omaha VA Medical Center. No significant difficulties were encountered by the patient or the evaluator regarding the quality of the audio/visual capabilities of the VTC link and its ability to facilitate preoperative evaluation. 87.5% of patients felt that virtual evaluation would save them travel time; 87.5% felt virtual evaluation could save them money; 7.3% felt uncomfortable using the VTC link; 12.2% felt the virtual evaluation took longer than expected; 70.7% preferred to be evaluated via VTC link; 21.9% were undecided; 9.7% felt they would rather be evaluated face-to-face with 26.8% undecided; 85.0% felt that teleconsultation was as good as being seen at the Omaha surgical evaluation unit; 7.5% were undecided. Our study has shown that effective preoperative evaluation can be performed using a virtual preoperative evaluation clinic; patients are receptive to the VTC format and, in the majority of cases, prefer it to face-to-face evaluation.

  5. An evaluation of rheumatology practitioner outreach clinics: a qualitative study.

    PubMed

    Abdelhamid, Asmaa S; Mooney, Janice; Walker, Andrew A; Barton, Garry; MacGregor, Alex J; Scott, David G I; Watts, Richard A

    2012-05-20

    Services for Rheumatoid Arthritis (RA) have evolved with the development of independently led outreach Rheumatology Practitioner (RP) clinics in Primary Care (PC). Their clinical and cost effectiveness, compared with Secondary Care (SC) services, has not been assessed. The RECIPROCATE study aims to evaluate their clinical and cost effectiveness. This part of the study aimed to explore health professionals' opinions of rheumatology outreach service. Using a qualitative design, semi-structured interviews were conducted with GPs, practice nurses, hospital doctors and RPs, from one hospital and seven PC practices in Norfolk, to elicit their opinions of the service. The interviews were analysed using thematic analysis. All participants agreed the service was supportive and valuable providing high quality personalised care, disease management, social, and educational support. Advantages identified included convenience, continuity of care and proximity of services to home. RPs helped bridge the communication gap between PC and SC. Some participants suggested having a doctor alongside RPs. The service was considered to be cost effective for patients but there was uncertainty about cost effectiveness for service providers. Few disadvantages were identified the most recurring being the lack of other onsite services when needed. It was noted that more services could be provided by RPs such as prescribing and joint injections as well as playing a more active role in knowledge transfer to PC. Professionals involved in the care of RA patients recognised the valuable role of the RP outreach clinics. This service can be further developed in rheumatology and the example can be replicated for other chronic conditions.

  6. [Analysis on evaluation tool for literature quality in clinical study].

    PubMed

    Liu, Qing; Zhai, Wei; Tan, Ya-qin; Huang, Juan

    2014-09-01

    The tools used for the literature quality evaluation are introduced. The common evaluation tools that are publicly and extensively used for the evaluation of clinical trial literature quality in the world are analyzed, including Jadad scale, Consolidated Standards of Reporting Trials (CONSORT) statement and Grades of Recommendations Assessment, Development and Evaluation (GRADE) system and the others. Additionally, the present development, updates and applications of these tools are involved in analysis.

  7. Psychosocial screening at paediatric BEEC clinics: a pilot evaluation study.

    PubMed

    Hurrell, Ruth A; Fullwood, Catherine; Keys, Joni; Dickson, Alan P; Fishwick, Janet; Whitnall, Beverley; Cervellione, Raimondo M

    2015-04-01

    but were not statistically significant. Mean scores on the measures used suggest a relatively optimistic picture of general psychosocial well-being, especially for HRQoL, in the BEEC population studied. Positive HRQoL outcomes have recently been reported for BEEC paediatric populations. Our results reflect this trend with better mean HRQoL scores than paediatric patients with a range of other chronic health conditions. However, this optimism is cautious given the limitations of this evaluation study and the high variation around the means. Limitations included the small sample size (especially for patients with cloacal exstrophy), the lack of a control group, the limited sensitivity of generic questionnaires in respect of BEEC-specific issues, and the low mean age of patients in the study. Future screening programmes may wish to consider measuring BEEC-specific variables (e.g. satisfaction with genital appearance/function); collecting information on medical aspects, such as continence, pubertal stage and frequency/timing of medical intervention; and asking both parents/carers (where possible) to complete the questionnaires. Screening questionnaire responses were used in conjunction with clinical psychology consultations to evaluate a range of psychosocial aspects in BEEC paediatric patients. Whilst mean scores on the measures used suggest a relatively optimistic picture, certain individual scores did fall within the clinical ranges, highlighting the potential need for further assessment. Developmentally tailored consultations with a clinical psychologist can provide detailed information around questionnaire responses and further assess BEEC specific aspects. Copyright © 2015 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

  8. An evaluation of rheumatology practitioner outreach clinics: a qualitative study

    PubMed Central

    2012-01-01

    Background Services for Rheumatoid Arthritis (RA) have evolved with the development of independently led outreach Rheumatology Practitioner (RP) clinics in Primary Care (PC). Their clinical and cost effectiveness, compared with Secondary Care (SC) services, has not been assessed. The RECIPROCATE study aims to evaluate their clinical and cost effectiveness. This part of the study aimed to explore health professionals’ opinions of rheumatology outreach service. Methods Using a qualitative design, semi-structured interviews were conducted with GPs, practice nurses, hospital doctors and RPs, from one hospital and seven PC practices in Norfolk, to elicit their opinions of the service. The interviews were analysed using thematic analysis. Results All participants agreed the service was supportive and valuable providing high quality personalised care, disease management, social, and educational support. Advantages identified included convenience, continuity of care and proximity of services to home. RPs helped bridge the communication gap between PC and SC. Some participants suggested having a doctor alongside RPs. The service was considered to be cost effective for patients but there was uncertainty about cost effectiveness for service providers. Few disadvantages were identified the most recurring being the lack of other onsite services when needed. It was noted that more services could be provided by RPs such as prescribing and joint injections as well as playing a more active role in knowledge transfer to PC. Conclusions Professionals involved in the care of RA patients recognised the valuable role of the RP outreach clinics. This service can be further developed in rheumatology and the example can be replicated for other chronic conditions. PMID:22607063

  9. An Alternative Study of Transfer of Learning in Clinical Evaluation.

    ERIC Educational Resources Information Center

    Patel, Vimla; Cranton, Patricia A.

    The use of an alternative methodology to study transfer of learning in clinical instruction during medical school was investigated. The environment in which clinical instruction takes place was examined, after which hypotheses were proposed and tested in a quasi-experimental design. The first phase of the study, an ethnographic analysis of the…

  10. Clinical evaluation of demineralized bone allograft for sinus lifts in humans: a clinical and histologic study.

    PubMed

    Won, Young-Hoon; Kim, Su-Gwan; Oh, Ji-Su; Lim, Sung-Chul

    2011-12-01

    Severe alveolar bony resorption in the edentulous posterior maxilla and pneumatization of the maxillary sinus wall make traditional implant placement impossible in the posterior maxilla. To reconstruct the severely resorbed maxilla for dental implant placement, 1 successful technique is to elevate the maxillary sinus floor using demineralized bone matrix (DBM) grafts. The purpose of this study was to evaluate a histologic and histomorphometric evaluation of DBM grafts in the human maxilla. Nine months after grafting, at the time of dental implantation, biopsy samples were taken from the grafted areas of 8 patients and were analyzed histologically. All the sinus lifts were successful in the clinical study conducted after implantation. Resorption of the graft materials and new bone formation were observed, and there was direct deposition of bone on the surface of the graft particles. The results of this study indicate that limited maxillary sinus lift with DBM graft material is a clinically reliable preimplant procedure.

  11. 76 FR 65781 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-24

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Research and Development Officer through the Director of the Clinical Science Research and Development...

  12. Pilot study of an Objective Structured Clinical Examination ("the Six Pack") for evaluating clinical competencies.

    PubMed

    Franzese, Christine B

    2008-02-01

    The purpose of this study was to evaluate an Objective Structured Clinical Examination (OSCE) designed to examine all six competencies and provide meaningful results to improve resident performance. A prospective, observational study. The OSCE consists of 1 hour for examination of a simulated patient, documentation, and feedback, with 30 minutes for an evidence-based medicine (EBM) test. Eight otolaryngology residents participated. Digital recordings and written documentation were evaluated on all competencies except practice-based learning. An EBM test was scored to assess practice-based learning. Overall, senior residents scored better. Seniors scored better on performing a focused history, whereas juniors scored better for thoroughness. Seniors coded better than juniors, although seniors tended to undercode and juniors tended to overcode. Two cases of "insurance fraud" were also discovered. The "Six Pack" successfully evaluated all competencies while providing valuable information. A clinical practicum was added to improve history and physical examination skills. The discussion of coding and a billing seminar also resulted. Residents believed the OSCE was valuable. Faculty members were impressed with the useful information obtained.

  13. Evaluating outpatient transition clinics: a mixed-methods study protocol

    PubMed Central

    Sattoe, Jane N T; Peeters, Mariëlle A C; Hilberink, Sander R; Ista, Erwin; van Staa, AnneLoes

    2016-01-01

    Introduction To support young people in their transition to adulthood and transfer to adult care, a number of interventions have been developed. One particularly important intervention is the transition clinic (TC), where paediatric and adult providers collaborate. TCs are often advocated as best practices in transition care for young people with chronic conditions, but little is known about TC models and effects. The proposed study aims to gain insight into the added value of a TC compared with usual care (without a TC). Methods and analysis We propose a mixed-methods study with a retrospective controlled design consisting of semistructured interviews among healthcare professionals, observations of consultations with young people, chart reviews of young people transferred 2–4 years prior to data collection and questionnaires among the young people included in the chart reviews. Qualitative data will be analysed through thematic analysis and results will provide insights into structures and daily routines of TCs, and experienced barriers and facilitators in transitional care. Quantitatively, within-group differences on clinical outcomes and healthcare use will be studied over the four measurement moments. Subsequently, comparisons will be made between intervention and control groups on all outcomes at all measurement moments. Primary outcomes are ‘no-show after transfer’ (process outcome) and ‘experiences and satisfaction with the transfer’ (patient-reported outcome). Secondary outcomes consider clinical outcomes, healthcare usage, self-management outcomes and perceived quality of care. Ethics The Medical Ethical Committee of the Erasmus Medical Centre approved the study protocol (MEC-2014-246). Dissemination Study results will be disseminated through peer-reviewed journals and conferences. The study started in September 2014 and will continue until December 2016. The same study design will be used in a national study in 20 diabetes settings (2016

  14. Sonographic evaluation of lipohemarthrosis: clinical and in vitro study.

    PubMed

    Bianchi, S; Zwass, A; Abdelwahab, I F; Ricci, G; Rettagliata, F; Olivieri, M

    1995-04-01

    The purpose of this study is to evaluate the role of sonography in diagnosing lipohemarthrosis. Sonography was performed on seven patients with intra-articular fractures of the knee, shoulder, and hip. An in vitro mixture of fat and blood was examined as the gold standard. In the patients scanned a few minutes after immobilization, a two-band appearance of joint effusion was present, representing a fat-blood level. One patient scanned 3 hours after immobilization showed a three-band appearance of joint effusion, corresponding to the layers of fat, serum and red blood cells. Results of this study indicate a high reliability of ultrasonography in detecting lipohemarthrosis.

  15. Clinical and radiographic evaluation of single tantalum dental implants: a prospective pilot clinical study

    PubMed Central

    DE FRANCESCO, M.; GOBBATO, E.A.; NOCE, D.; CAVALLARI, F.; FIORETTI, A.

    2016-01-01

    SUMMARY Objective The aim of this prospective pilot clinical case series report was to evaluate, through a clinical and radiographic analysis, the peri-implant bone resorption of the tantalum dental implants (TMT) (Zimmer TMT, Parsippany, NJ, USA) one year after prosthetic rehabilitation. Methods Twenty tantalum dental implants were placed in both maxillas and mandibles of 20 patients. Patients were asked to attend a radiographic and clinical follow-up and their previous clinical records and X-rays were assessed. Bone levels were calculated by digitally measuring the distance from the implant shoulder to the first bone-to-implant on periapical radiographs taken at surgery and after 6 and 12 months of functioning. The Pearson correlation analysis was performed to assess it there was a correlation between the measurement of the marginal bone loss (MBL). The Anova Test with a post-hoc analysis using Bonferroni’s test was used to compare the three group (0, 6 months and 12 months). Results The mean total MBL for the group 0 months was 0.84 mm (SD 0.21), 6 months was 0.87 mm (SD 0.22) and for 12 months was 0.89 mm (SD 0.23). The values of the Pearson’s coefficients showed that the data measurement were positively correlated. The Anova test showed a statistically significant difference between the groups. Conclusion The statistically significant difference in marginal bone loss can be considered physiological. Within the limits of this study it can be concluded that TMT implants have an excellent bone crest’s stability, however, to have most accurate information, will be necessary extend the sample. PMID:28280531

  16. [Clinical application of extracts of Echinacea purpurea or Echinacea pallida. Critical evaluation of controlled clinical studies].

    PubMed

    Dorsch, W

    1996-04-01

    The phytotherapy should be understood as being integrated into the rational pharmacotherapy. The modern phytotherapy tries hard to proof effects with pharmacological and clinical studies. The task force E of the federal bureau of health of Germany has made a statement regarding this problem. This article reviews only controlled clinical trials about the application of extracts of echinacea purpura or echinacea pallida.

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

    PubMed Central

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

    2014-01-01

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

  18. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  19. Clinical Observed Performance Evaluation: A Prospective Study in Final Year Students of Surgery

    ERIC Educational Resources Information Center

    Markey, G. C.; Browne, K.; Hunter, K.; Hill, A. D.

    2011-01-01

    We report a prospective study of clinical observed performance evaluation (COPE) for 197 medical students in the pre-qualification year of clinical education. Psychometric quality was the main endpoint. Students were assessed in groups of 5 in 40-min patient encounters, with each student the focus of evaluation for 8 min. Each student had a series…

  20. 78 FR 53015 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-08-27

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Chief Research and Development Officer through the Director of the Clinical Science Research and...

  1. 75 FR 79446 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-20

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  2. 76 FR 73781 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  3. 77 FR 72438 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-05

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

  4. 78 FR 70102 - Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-22

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies; Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... the Director of the Clinical Science Research and Development Service on the relevance and feasibility...

  5. 75 FR 28686 - Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-05-21

    ... AFFAIRS Clinical Science Research and Development Service; Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Committee advises the Chief Research and Development Officer through the Director of the Clinical Science...

  6. 78 FR 41198 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-09

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and Development Service Cooperative... Research and Development Officer through the Director of the Clinical Science Research and Development...

  7. Challenges in Evaluating Clinical Governance Systems in Iran: A Qualitative Study

    PubMed Central

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-01-01

    Background: In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. Objectives: This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. Materials and Methods: For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Results: Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Conclusions: Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead. PMID:24910799

  8. Challenges in evaluating clinical governance systems in iran: a qualitative study.

    PubMed

    Hooshmand, Elaheh; Tourani, Sogand; Ravaghi, Hamid; Ebrahimipour, Hossein

    2014-04-01

    In spite of the pivotal role of clinical governance in enhancing quality of services provided by hospitals across the country, a scientific framework with specific criteria for evaluating hospitals has not been developed so far. This study was conducted with the aim to identify the challenges involved in evaluating systems of clinical governance in Iran. For the purposes of this qualitative study, 15 semi-structured interviews with experts in the field were conducted in 2011 and the data were analyzed using framework analysis method. Five major challenges in evaluating clinical governance include managing human resources, improving clinical quality, managing development, organizing clinical governance, and providing patient-oriented healthcare system. Healthcare system in Iran requires a clinical governance program which has a patient-oriented approach in philosophy, operation, and effectiveness in order to meet the challenges ahead.

  9. An evaluation of the clinical potential of tissue diffraction studies

    NASA Astrophysics Data System (ADS)

    Speller, R.; Abuchi, S.; Zheng, Y.; Vassiljev, N.; Konstantinidis, A.; Griffiths, J.

    2015-09-01

    Medical imaging is a long established part of patient management in the treatment of disease. However, in most cases it only provides anatomical detail and does not provide any form of tissue characterisation. This is particularly true for X-ray imaging. Recent studies on tissue diffraction have shown that true molecular signatures can be derived for different tissue types. Breast cancer samples and liver tissue have been studied. It has been shown that diffraction profiles can be traced away from the primary tumour in excised breast tissue samples and that potentially 3mm fat nodules in liver tissue can be identified in patients at acceptable doses.

  10. 77 FR 31072 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-24

    ... No: 2012-12522] DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service... Science Research and Development Service Cooperative Studies Scientific Evaluation Committee will be held... Research and Development Officer through the Director of the Clinical Science Research and Development...

  11. 76 FR 19189 - Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-06

    ... AFFAIRS Clinical Science Research and Development Service Cooperative Studies Scientific Evaluation... (Federal Advisory Committee Act) that a meeting of the Clinical Science Research and Development Service... Science Research and Development Service on the relevance and feasibility of proposed projects and the...

  12. Case studies on clinical evaluation of biosimilar monoclonal antibody: scientific considerations for regulatory approval.

    PubMed

    Kudrin, Alex; Knezevic, Ivana; Joung, Jeewon; Kang, Hye-Na

    2015-01-01

    The objective of this paper is to provide considerations based on comprehensive case studies important for regulatory evaluation of monoclonal antibodies as similar biotherapeutic products (SBPs) with a special emphasis on clinical aspects. Scientific principles from WHO Guidelines on SBPs were used as a basis for the exercise. Working groups consisted of regulators, manufacturers and academia. The following topics were discussed by the working groups: clinical criteria for biosimilarity, extrapolation approach and the overall regulatory decision making process. In order to determine typical pitfalls in the design of a SBP clinical programme and evaluate the gap of knowledge, amongst different industry and regulatory stakeholders on the appraisal of the data arising from SBP clinical studies, we have presented two fictional but realistic clinical case studies. The first case consists of the fictional development programme for an infliximab SBP candidate. The second case describes clinical studies proposed for a fictional rituximab SBP candidate. In the first scenario a highly similar quality profile has been taken forward into clinical studies whereas there was an important residual difference in functional attributes for the rituximab SBP candidate. These case studies were presented at the WHO implementation workshop for the WHO guidelines on evaluation of similar biotherapeutic products held in Seoul, Republic of Korea, in May 2014. The goal was to illustrate the interpretation of the clinical data arising from studies with SBP candidates and elicit knowledge gaps in clinical assessment. This paper reflects the outcome of the exercise and discussions held in Seoul and offers an analysis of the case studies as a learning opportunity on clinical development and evaluation of SBPs.

  13. Two-year clinical evaluation of resin composite in posterior teeth: A randomized controlled study

    PubMed Central

    Gianordoli-Neto, Ranulfo; Padovani, Gislaine Cristina; Mondelli, José; de Lima Navarro, Maria Fidela; Mendonça, Juliano Sartori; Santiago, Sérgio Lima

    2016-01-01

    Background: Clinical evaluations as fundamental method to prove the efficiency of restorative materials. Aim: This study evaluated the clinical performance of restorative systems during 2 years of clinical service. Materials and Methods: This study assessed the clinical performance of restorative systems (Filtek Z250 and P60), during 2 years of clinical service, using the US Public Health Service system. The randomized and double-blind study comprising thirty volunteers. The restorations were evaluated at baseline, 6, 12, and 24 months. It was used the following criteria: marginal discoloration (MD), marginal integrity (MI), superficial texture (ST), wear (W), postoperative sensitivity (PS) and recurrent caries (RC). Results: Statistic analysis was performed using Fisher's and McNemar's exact tests and Pearsons's Chi-square in a significance level of 5%. The results at baseline and 24 months for Group I were: MD – 100, 100%; MI – 100, 88.6%; ST – 100, 94.3%; W – 100, 94.3%; PS – 100, 100%; RC – 100, 100%, of alpha scores; Group II: MD – 100, 97.1%; MI – 100, 91.4%; ST – 100, 94.3%; W – 100, 91.4%; PS – 100, 100%; RC – 100, 100%, of alpha scores. It was observed no statistical difference in the evaluated criteria and period. Conclusions: After 24 months of evaluation, both restorative systems exhibited acceptable clinical performance. PMID:27563176

  14. In silico imaging clinical trials for regulatory evaluation: initial considerations for VICTRE, a demonstration study

    NASA Astrophysics Data System (ADS)

    Badano, Aldo; Badal, Andreu; Glick, Stephen; Graff, Christian G.; Samuelson, Frank; Sharma, Diksha; Zeng, Rongping

    2017-03-01

    Expensive and lengthy clinical trials can delay regulatory evaluation and add significant burden that stifles innovation affecting patient access to novel, high-quality imaging technologies. In silico imaging holds promise for evaluating the safety and effectiveness of imaging technologies with much less burden than clinical trials. We define in silico imaging as a computer simulation of an entire imaging system (including source, object, task, and observer components) used for research, development, optimization, technology assessment, and regulatory evaluation of new technology. In this work we describe VICTRE (our study of virtual imaging clinical trials for regulatory evaluation) and the considerations for building an entire imaging pipeline in silico including device (physics), patient (anatomy, disease), and image interpretation models for regulatory evaluation using open-source tools.

  15. First Results Of The Diagnostic Evaluation Studies And The Clinical Efficacy Evaluation In The Dutch PACS Project

    NASA Astrophysics Data System (ADS)

    Barneveld Binkhuysen, F. H.; Ottes, F. P.; ter Haar Romeny, B. M.; Klessens, P. L. M.; Vos, C. G.; Winter, L. H. L.; Calkoen, P. T.; Andriessen, J. H. T. H.

    1989-05-01

    The objective of the studies was to evaluate the diagnostic performance of the image digitizing distribution and display equipment of the installed PACS (Philips) in the Utrecht University Hospital (see also procee-dings SPIE 914, 1988). The diagnostic accuracy was evaluated by means of observer performance studies, using ROC analysis. Three series of films were used: chest phantom radiographs, clinical mammographic films, and clinical head CT's. We compared: original films versus images digitized with a video scanner, and/or original films versus images digitized with a laser scanner. Both scanners have 1024x1024x8 bits output resolution. Four radiologists scored the presence on a 5-point scale. The results of the mammographic and head CT series will be presented in this paper. The results of the diagnostic accuracy studies of the chest radiographs and their specific methodology will be presented in a companion SPIE paper. Goal of the clinical efficacy study is to see if the use of a PACS multimodality viewing station at an internal ward has clinical advantages as compared to the conventional situation. Using PACS integrated with a HIS (including a RIS) more easier and faster information is accessible to the clinicians. In this paper we will describe: the procedures which are needed to evaluate the use of the workstation installed at the internal ward, the development of the user interface with four layers of the Image Management System, and the methodology of evaluation the clinical advantages.

  16. STP Best Practices for Evaluating Clinical Pathology in Pharmaceutical Recovery Studies.

    PubMed

    Tomlinson, Lindsay; Ramaiah, Lila; Tripathi, Niraj K; Barlow, Valerie G; Vitsky, Allison; Poitout-Belissent, Florence M; Bounous, Denise I; Ennulat, Daniela

    2016-02-01

    The Society of Toxicologic Pathology formed a working group in collaboration with the American Society for Veterinary Clinical Pathology to provide recommendations for the appropriate inclusion of clinical pathology evaluation in recovery arms of nonclinical toxicity studies but not on when to perform recovery studies. Evaluation of the recovery of clinical pathology findings is not required routinely but provides useful information on risk assessment in nonclinical toxicity studies and is recommended when the ability of the organ to recover is uncertain. The study design generally requires inclusion of concurrent controls to separate procedure-related changes from test article-related changes, but return of clinical pathology values toward baseline may be sufficient in some cases. Evaluation of either a select or full panel of standard hematology, coagulation, and serum and urine chemistry biomarkers can be scientifically justified. It is also acceptable to redesignate dosing phase animals to the recovery phase or vice versa to optimize data interpretation. Assessment of delayed toxicity during the recovery phase is not required but may be appropriate in development programs with unique concerns. Evaluation of the recovery of clinical pathology data for vaccine development is required and, for efficacy markers, is recommended if it furthers pharmacologic understanding. © The Author(s) 2016.

  17. Public availability of results of observational studies evaluating an intervention registered at ClinicalTrials.gov.

    PubMed

    Baudart, Marie; Ravaud, Philippe; Baron, Gabriel; Dechartres, Agnes; Haneef, Romana; Boutron, Isabelle

    2016-01-28

    Observational studies are essential for assessing safety. The aims of this study were to evaluate whether results of observational studies evaluating an intervention with safety outcome(s) registered at ClinicalTrials.gov were published and, if not, whether they were available through posting on ClinicalTrials.gov or the sponsor website. We identified a cohort of observational studies with safety outcome(s) registered on ClinicalTrials.gov after October 1, 2007, and completed between October 1, 2007, and December 31, 2011. We systematically searched PubMed for a publication, as well as ClinicalTrials.gov and the sponsor website for results. The main outcomes were the time to the first publication in journals and to the first public availability of the study results (i.e. published or posted on ClinicalTrials.gov or the sponsor website). For all studies with results publicly available, we evaluated the completeness of reporting (i.e. reported with the number of events per arm) of safety outcomes. We identified 489 studies; 334 (68%) were partially or completely funded by industry. Results for only 189 (39%, i.e. 65% of the total target number of participants) were published at least 30 months after the study completion. When searching other data sources, we obtained the results for 53% (n = 158; i.e. 93% of the total target number of participants) of unpublished studies; 31% (n = 94) were posted on ClinicalTrials.gov and 21% (n = 64) on the sponsor website. As compared with non-industry-funded studies, industry-funded study results were less likely to be published but not less likely to be publicly available. Of the 242 studies with a primary outcome recorded as a safety issue, all these outcomes were adequately reported in 86% (114/133) when available in a publication, 91% (62/68) when available on ClinicalTrials.gov, and 80% (33/41) when available on the sponsor website. Only 39% of observational studies evaluating an intervention with safety outcome

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

    PubMed

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

    2015-06-01

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

  19. [Evaluation of secondary care in oral health: a study of specialty clinics in Brazil].

    PubMed

    Goes, Paulo Sávio Angeiras de; Figueiredo, Nilcema; Neves, Jerlucia Cavalcanti das; Silveira, Fabiana Moura da Motta; Costa, José Felipe Riani; Pucca Júnior, Gilberto Alfredo; Rosales, Maritza Sosa

    2012-01-01

    This article discusses the evaluation of secondary care in the area of health surveillance. This was a descriptive and normative/evaluative study. Performance analysis drew on secondary data, based on a historical series of dental procedures conducted at the specialized dental clinics implemented in Brazil and recorded by the Outpatient Information System of the Unified National Health System (SIA/SUS) in 2007, as well as primary data from site visits to the clinics, based on questionnaires completed by clinic staff. Performance of the clinics was poor in most regions of the country, and the North of Brazil had the lowest percentage of specialty services implemented. The indicator "Performance of Secondary Care in Oral Health" was 64.4%. The type 3 specialty clinics showed better results in terms of performance and achievement of targets. The study showed the need to review the legal framework for implementing specialized dental clinics by adjusting the criteria and norms, as well as definition of new standards for achievement of goals in the evaluation and monitoring of these services.

  20. Evaluation of the IVAC 560 volumetric pump. A clinical and laboratory study.

    PubMed

    Hutchinson, A; Yeoman, P M; Byrne, A J

    1985-10-01

    The performance of a new combined infusion pump and central venous pressure monitor, the IVAC 560, has been evaluated in laboratory and clinical studies. The pump performed accurately and reliably, and the pressure readings obtained from the pump correlated well with conventional methods of pressure measurement, although they lost accuracy when using 50% dextrose at higher venous pressures.

  1. Evaluation of clinical pathology data: correlating changes with other study data.

    PubMed

    Everds, Nancy E

    2015-01-01

    During the conduct of in vivo toxicology studies, in-life, clinical pathology, and anatomic pathology parameters are collected and interpreted. These sets of parameters are evaluated in an integrative manner to determine the overall toxicity of a test article. For clinical pathology parameters, the inherent variability and physiologic factors affecting each analyte must be understood prior to interpretation. Changes in clinical pathology parameters that are considered to be test article-related are then assessed with respect to changes in the concurrent data sets such as clinical signs and anatomic pathology to determine the underlying pathophysiology. In this article, examples of hemolysis and hepatotoxicity are used to demonstrate the relationships among the various parameters and data sets. Whereas there was tight correlation of all data sets in the example of hemolysis in rats, the examples of altered enzymes and other biomarkers indicating liver injury and dysfunction were more often discordant with other data sets. © 2014 by The Author(s).

  2. Evaluation of Clinical Competence.

    ERIC Educational Resources Information Center

    Newble, David I.

    In Australia the usual evaluation of whether a student will perform adequately as a doctor is a subjective evaluation of his clinical performance, usually at the completion of five or six years at medical school. The evaluation is performed on an inadequate and uncontrolled patient sample and appears to be subject to many errors. Recent work…

  3. Longitudinal clinical evaluation of bonded composite inlays: a 3-year study.

    PubMed

    Barone, Antonio; Derchi, Giacomo; Rossi, Angelo; Marconcini, Simone; Covani, Ugo

    2008-01-01

    The aims of this prospective clinical study were (1) to evaluate the clinical performance of Signum composite inlays over a 3-year period; (2) to investigate the clinical efficacy of composite inlays in premolars versus molars; and (3) to evaluate differences between 1- or 2-surface inlays and multisurface inlays. One hundred thirteen composite inlays were placed in 30 patients by a clinician. All the inlays were made by the same laboratory technician using only one composite material (Signum, Heraeus Kulzer). All the restorations were bonded with a 3-step bonding system and a composite luting cement. The restorations were assessed after placement by a clinician who had not been involved with the placement of the restorations, in accordance with the modified US Public Health Service criteria. Three of the 113 experimental restorations had to be replaced; the total failure rate was 2.6% after 3 years. At baseline, 88.5% to 100% of the inlay restorations were rated as excellent (Alpha). Statistically significant (P < .05) differences were observed during the study for surface roughness, anatomic form at the margin, marginal integrity, and inlay integrity. The comparison of the clinical outcome of inlays in premolars versus molars and with 1 or 2 surfaces versus multisurfaces showed no significant differences, except for the parameters anatomic form at the margin and marginal integrity. Composite inlays demonstrated a very high success rate (97.4%) after 3 years. Neither the size of the restorations nor the tooth type significantly affected the clinical outcome of the restorations.

  4. Evaluating Creative Thinking of Rn-Bsn Students in the Course of Clinical Case Study and Practicum

    ERIC Educational Resources Information Center

    Ku, Ya-Lie

    2015-01-01

    This case study evaluated creative thinking of RN-BSN students in the course of clinical case study and practicum. Study design used quantitative and qualitative evaluations of creative thinking of RN-BSN students by triangulation method in the course of clinical case study and practicum. Sixty RN-BSN students self-perceived the changing levels of…

  5. Evaluating Creative Thinking of Rn-Bsn Students in the Course of Clinical Case Study and Practicum

    ERIC Educational Resources Information Center

    Ku, Ya-Lie

    2015-01-01

    This case study evaluated creative thinking of RN-BSN students in the course of clinical case study and practicum. Study design used quantitative and qualitative evaluations of creative thinking of RN-BSN students by triangulation method in the course of clinical case study and practicum. Sixty RN-BSN students self-perceived the changing levels of…

  6. Clinical Evaluation of the Retention of Different Pit and Fissure Sealants: A 1-Year Study

    PubMed Central

    Kumaran, Parvathy

    2013-01-01

    ABSTRACT Objective: The aim of this study was to evaluate the retention of different pit and fissure sealants on the first permanent molars over a period of one year. Materials and methods: In this study, a total of 40 children with all first permanent molars erupted received four different pit and fissure sealants. The children were evaluated at 6 and 12 months. Results: The data was subjected to Chi-square test and Kaplan Meier survival analysis. The p-value was calculated using Wilcoxon matched-pairs signed-rank test. Conclusion: The retention rates of resin-based sealants were superior to that of glass ionomer sealant. How to cite this article: Kumaran P. Clinical Evaluation of the Retention of Different Pit and Fissure Sealants: A 1-Year Study. Int J Clin Pediatr Dent 2013;6(3):183-187. PMID:25206219

  7. Clinical Evaluation of Tinnitus.

    PubMed

    Hertzano, Ronna; Teplitzky, Taylor B; Eisenman, David J

    2016-05-01

    The clinical evaluation of patients with tinnitus differs based on whether the tinnitus is subjective or objective. Subjective tinnitus is usually associated with a hearing loss, and therefore, the clinical evaluation is focused on an otologic and audiologic evaluation with adjunct imaging/tests as necessary. Objective tinnitus is divided into perception of an abnormal somatosound or abnormal perception of a normal somatosound. The distinction between these categories is usually possible based on a history, physical examination, and audiogram, leading to directed imaging to identify the underlying abnormality.

  8. Prospective clinical observational study evaluating gender-associated differences of preoperative pain intensity

    PubMed Central

    Tafelski, Sascha; Kerper, Léonie F; Salz, Anna-Lena; Spies, Claudia; Reuter, Eva; Nachtigall, Irit; Schäfer, Michael; Krannich, Alexander; Krampe, Henning

    2016-01-01

    Abstract Previous studies reported conflicting results concerning different pain perceptions of men and women. Recent research found higher pain levels in men after major surgery, contrasted by women after minor procedures. This trial investigates differences in self-reported preoperative pain intensity between genders before surgery. Patients were enrolled in 2011 and 2012 presenting for preoperative evaluation at the anesthesiological assessment clinic at Charité University hospital. Out of 5102 patients completing a computer-assisted self-assessment, 3042 surgical patients with any preoperative pain were included into this prospective observational clinical study. Preoperative pain intensity (0–100 VAS, visual analog scale) was evaluated integrating psychological cofactors into analysis. Women reported higher preoperative pain intensity than men with median VAS scores of 30 (25th–75th percentiles: 10–52) versus 21 (10–46) (P < 0.001). Adjusted multiple regression analysis showed that female gender remained statistically significantly associated with higher pain intensity (P < 0.001). Gender differences were consistent across several subgroups especially with varying patterns in elderly. Women scheduled for minor and moderate surgical procedures showed largest differences in overall pain compared to men. This large clinical study observed significantly higher preoperative pain intensity in female surgical patients. This gender difference was larger in the elderly potentially contradicting the current hypothesis of a primary sex-hormone derived effect. The observed variability in specific patient subgroups may help to explain heterogeneous findings of previous studies. PMID:27399095

  9. Development and evaluation of a PBL-based continuing education for clinical nurses: a pilot study.

    PubMed

    Kim, Hee Soon; Hwang, Seon Young; Oh, Eui Geum; Lee, Jae Eun

    2006-12-01

    The purposes of this study were to develop a PBL program for continuing nurse education and to evaluate the program after its implementation. The PBL program was developed in the core cardio-pulmonary nursing concepts through a collaborative approach with a nursing school and a hospital. The PBL packages with simulation on ACLS were implemented to 40 clinical nurses. The entire PBL program consisted of six 3-hour weekly classes and was evaluated by the participants' subjective responses. Two PBL packages in cardio-pulmonary system including clinical cases and tutorial guidelines were developed. The 57.5% of the participants responded positively about the use of PBL as continuing nurse education in terms of self-motivated and cooperative learning, whereas 20.0% of the participants answered that the PBL method was not suitable for clinical nurses. Some modifications were suggested in grouping participants and program contents for PBL. The PBL method could be utilized to promote nurses' clinical competencies as well as self-learning abilities. Further research is needed in the implementation strategies of PBL-based continuing education in order to improve its effectiveness.

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

    PubMed

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

    2017-08-01

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

  11. Report on the use of non-clinical studies in the regulatory evaluation of oncology drugs.

    PubMed

    Hayakawa, Yoshihiro; Kawada, Manabu; Nishikawa, Hiroyoshi; Ochiya, Takahiro; Saya, Hideyuki; Seimiya, Hiroyuki; Yao, Ryoji; Hayashi, Masahiro; Kai, Chieko; Matsuda, Akira; Naoe, Tomoki; Ohtsu, Atsushi; Okazaki, Taku; Saji, Hideo; Sata, Masataka; Sugimura, Haruhiko; Sugiyama, Yuichi; Toi, Masakazu; Irimura, Tatsuro

    2016-02-01

    Non-clinical studies are necessary at each stage of the development of oncology drugs. Many experimental cancer models have been developed to investigate carcinogenesis, cancer progression, metastasis, and other aspects in cancer biology and these models turned out to be useful in the efficacy evaluation and the safety prediction of oncology drugs. While the diversity and the degree of engagement in genetic changes in the initiation of cancer cell growth and progression are widely accepted, it has become increasingly clear that the roles of host cells, tissue microenvironment, and the immune system also play important roles in cancer. Therefore, the methods used to develop oncology drugs should continuously be revised based on the advances in our understanding of cancer. In this review, we extensively summarize the effective use of those models, their advantages and disadvantages, ranges to be evaluated and limitations of the models currently used for the development and for the evaluation of oncology drugs.

  12. Trial Design and Endpoint Evaluation in Clinical Studies Addressing Chronic Back Pain.

    PubMed

    Staats, Peter S

    2017-07-15

    A review of the literature evaluating clinical trials of chronic back pain. To assist physicians in assessing the quality of clinical trial data to make the most informed treatment decisions. Chronic pain is a tremendous public health issue, affecting close to 100 million adults in the United States, and costs the American people billions of dollars. One traditional treatment approach, the long-term use of opiate medications, has recently come under intense scrutiny for problems with complications, diversion, abuse, addiction, and lack of efficacy. In addition, the Centers for Disease Control and Prevention has recognized that overprescribing opiates has enabled an overdose crisis, and written guidelines that are intended to limit their use. It is for this reason that physicians must have a comprehensive understanding of the range of drug-free alternative therapies available and have the tools needed to rigorously evaluate the chronic pain literature so they can make appropriate treatment decisions. An evaluation of how clinical trials are designed and ranked, outcome measures, and costs for a variety of therapies is necessary to determine which treatment option is the most efficacious for an individual patient. Clinical trial data demonstrate that spinal cord stimulation (SCS) is a safe and effective treatment option for many types of chronic pain, including back pain. The last 10 years has brought tremendous advances in the field of neuromodulation. Today, several treatment modalities exist for SCS requiring the physician to be able to critically evaluate and interpret the literature and determine which modality has the strongest evidence. When evaluating clinical trial data of patients with chronic back pain, emphasis must be placed on well designed, randomized controlled trials with long-term follow-up producing level I evidence. These data are obtained in a rigorous manner and are likely to have less bias when compared with lower level studies. The level I

  13. Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

    PubMed

    Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

    2015-06-01

    National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program

  14. Clinical and functional evaluation of the efficacy of otilonium bromide: a multicenter study in Italy.

    PubMed

    Baldi, F; Longanesi, A; Blasi, A; Monello, S; Cestari, R; Missale, G; Corazziari, E; Badiali, G; Pescatori, M; Anastasio, G

    1991-11-01

    Seventy-two patients complaining of abdominal pain were studied in a double blind trial with otilonium bromide (OB) (40 mg tid or placebo). In our patients we performed, before and after the treatment, a clinical evaluation (symptom variations) and functional studies (sigmoid manometry during bowel distension). As regards clinical parameters, otilonium bromide significantly reduced abdominal pain and bloating and significantly increased (p less than 0.02) the pain threshold. However the comparison with the placebo group did not show any difference between the two groups. Sigmoid motility during distension was significantly reduced (p less than 0.05) in OB group, whereas it did not change in the placebo group. We can conclude that, in irritable bowel syndrome (IBS) patients, OB is able to improve symptoms and to reduce stimulated motor activity of the sigmoid.

  15. Fraser syndrome: a clinical study of 59 cases and evaluation of diagnostic criteria.

    PubMed

    van Haelst, Mieke M; Scambler, Peter J; Hennekam, Raoul C M

    2007-12-15

    Fraser syndrome is an autosomal recessive congenital malformation syndrome characterized by cryptophthalmos, syndactyly, and urogenital defects. We studied the clinical features in 59 affected individuals from 40 families (25 consanguineous), and compared our findings to data from previous reviews. We found a higher frequency of abnormalities of the skull, larynx, umbilicus, urinary tract, and anus in our series of patients, and mental retardation and cleft lip with or without cleft palate were observed less frequently than previously reported. Clinical features in probands and sibs were remarkably similar. As can be expected prenatally diagnosed patients had more manifestations that gave rise to a pathological amount of amniotic fluid. Otherwise patients diagnosed before and after birth had similar frequencies of symptoms. Based on the present results we suggest an adaptation of diagnostic criteria for FS, including adding airway tract and urinary tract anomalies as major criteria. The specificity of the proposed diagnostic criteria was evaluated using the London Medical Database as a search tool.

  16. Evaluation of tooth-fragment reattachment: a clinical and laboratory study.

    PubMed

    Yilmaz, Yucel; Guler, Cigdem; Sahin, Hakan; Eyuboglu, Ozge

    2010-08-01

    To evaluate the restoration of fractured teeth by reattaching tooth fragment to its tooth remnant in a group of children and adolescents, and to compare the results with those of a laboratory study. The clinical study was conducted on 43 fractured incisors: 22 uncomplicated crown fractures (Group A) and 21 complicated crown fractures (Group B). The 43 incisal fragments: 23 were kept dry for 47 h and 20 were kept wet for 24 h by the patients before they were reattached. The fragments were kept in 0.9% saline solution for 30 min before reattachment. The fragments in Group A were reattached using a dentin bonding agent, a flowable and a hybrid resin composite, whereas the fragments in Group B were reattached to the tooth remnant after a pulpotomy was performed. The laboratory study was conducted on 56 extracted incisors. Teeth were divided equally into four groups: Group I - Uncomplicated crown fracture + wet medium; Group II - Uncomplicated crown fracture + dry medium; Group III - Complicated crown fracture + wet medium, and Group IV - Complicated crown fracture + dry medium. The fragments were then reattached in a manner that was similar to that used in the clinical study. The restored teeth were then re-fractured. All data were analyzed statistically. In the clinical study, the restored teeth were followed up for 2 years. Neither the type of trauma nor the storage medium had any significant effect on the survival, color, and bond strength of the restored teeth when assessed in the clinical and laboratory study. The color disharmony that was encountered initially in restored teeth resolved significantly on its own accord within 12 months after reattachment of the fragment. Fragment reattachment can be used to treat fractured teeth successfully in children and adolescents.

  17. Evaluation of clinical outcomes with alvimopan in clinical practice: a national matched-cohort study in patients undergoing bowel resection.

    PubMed

    Delaney, Conor P; Craver, Christopher; Gibbons, Melinda M; Rachfal, Amy W; VandePol, Christine J; Cook, Suzanne F; Poston, Sara A; Calloway, Michael; Techner, Lee

    2012-04-01

    To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment. Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan--a peripherally acting μ-opioid receptor antagonist--accelerated gastrointestinal recovery after open BR. A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population). Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P ≤ 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P ≤ 0.0008 for each). On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved

  18. A randomized controlled clinical study evaluating the efficacy of two desensitizing dentifrices.

    PubMed

    Salian, Sowmya; Thakur, Srinath; Kulkarni, Sudhindra; LaTorre, Guy

    2010-01-01

    The primary aim of this study was to compare the in vivo efficacy and safety of dentifrices containing either 5% NovaMin or 5% potassium nitrate, and a non-desensitizing dentifrice, on dentin hypersensitivity in a four-week, double-blind clinical study among a population in south India. In addition, a companion scanning electron microscopy evaluation was performed to demonstrate whether or not the test products occlude open dentin tubules in vitro. Thirty volunteers with tooth sensitivity were recruited, and a double-blind, randomized, parallel, controlled clinical trial was conducted in a hospital setting. Clinical evaluation for dentin hypersensitivity was done using tactile, air blast, and cold water methods. Following baseline measures, subjects were randomly divided into three groups and treated as follows: Group A--dentifrice containing 5% potassium nitrate; Group B--dentifrice containing 5% NovaMin; and Group C--dentifrice containing no desensitizing ingredients. Clinical evaluations were repeated after two and four weeks of product use. Compared to baseline, there was a significant decrease in dentin hypersensitivity in Groups A and B following four weeks' use of the dentifrice containing 5% potassium nitrate and the dentifrice containing 5% calcium sodium phosphosilicate (NovaMin), respectively. There was a statistically greater reduction in hypersensitivity at both two and four weeks following use of the dentifrice containing NovaMin compared with the use of a non-desensitizing dentifrice, as well as the dentifrice containing potassium nitrate. Air and cold water scores were significantly lower following four weeks' use of the potassium nitrate dentifrice compared to the non-desensitizing dentifrice. Tubule occlusion was observed in the companion in vitro study following treatment with 5% NovaMin, but not after treatment with the 5% potassium nitrate or non-desensitizing dentifrices. The results suggest that the dentifrice containing 5% NovaMin occludes

  19. Clinical evaluation of ridge augmentation using autogenous tooth bone graft material: case series study.

    PubMed

    Lee, Ji-Young; Kim, Young-Kyun; Yi, Yang-Jin; Choi, Joon-Ho

    2013-08-01

    Interest in bone graft material has increased with regard to restoration in cases of bone defect around the implant. Autogenous tooth bone graft material was developed and commercialized in 2008. In this study, we evaluated the results of vertical and horizontal ridge augmentation with autogenous tooth bone graft material. This study targeted patients who had vertical or horizontal ridge augmentation using AutoBT from March 2009 to April 2010. We evaluated the age and gender of the subject patients, implant stability, adjunctive surgery, additional bone graft material and barrier membrane, post-operative complication, implant survival rate, and crestal bone loss. We performed vertical and horizontal ridge augmentation using powder- or block-type autogenous tooth bone graft material, and implant placement was performed on nine patients (male: 7, female: 2). The average age of patients was 49.88±12.98 years, and the post-operative follow-up period was 35±5.31 months. Post-operative complications included wound dehiscence (one case), hematoma (one case), and implant osseointegration failure (one case; survival rate: 96%); however, there were no complications related to bone graft material, such as infection. Average marginal bone loss after one-year loading was 0.12±0.19 mm. Therefore, excellent clinical results can be said to have been obtained. Excellent clinical results can be said to have been obtained with vertical and horizontal ridge augmentation using autogenous tooth bone graft material.

  20. Driving clinical study efficiency by using a productivity breakdown model: comparative evaluation of a global clinical study and a similar Japanese study.

    PubMed

    Takahashi, K; Sengoku, S; Kimura, H

    2011-02-01

    A fundamental management imperative of pharmaceutical companies is to contain surging costs of developing and launching drugs globally. Clinical studies are a research and development (R&D) cost driver. The objective of this study was to develop a productivity breakdown model, or a key performance indicator (KPI) tree, for an entire clinical study and to use it to compare a global clinical study with a similar Japanese study. We, thereby, hope to identify means of improving study productivity. We developed the new clinical study productivity breakdown model, covering operational aspects and cost factors. Elements for improving clinical study productivity were assessed from a management viewpoint by comparing empirical tracking data from a global clinical study with a Japanese study with similar protocols. The following unique and material differences, beyond simple international difference in cost of living, that could affect the efficiency of future clinical trials were identified: (i) more frequent site visits in the Japanese study, (ii) head counts at the Japanese study sites more than double those of the global study and (iii) a shorter enrollment time window of about a third that of the global study at the Japanese study sites. We identified major differences in the performance of the two studies. These findings demonstrate the potential of the KPI tree for improving clinical study productivity. Trade-offs, such as those between reduction in head count at study sites and expansion of the enrollment time window, must be considered carefully. © 2010 Blackwell Publishing Ltd.

  1. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study.

    PubMed

    Naeselius, Katarina; Arnelund, Carl-Fredrik; Molin, Margareta K

    2008-01-01

    The aim of the present study was to evaluate the clinical outcome of extensive Empress onlays retained with resin-bonded cement. One hundred thirty extensive ceramic onlays were placed in premolar and molar regions in 91 patients treated by 2 general practitioners between 1997 and 2000. Seventy-seven percent of the constructions were luted with chemically cured resin composite cement and 23% were luted with dual-cured resin cement. Fifty-nine patients with 81 restorations were clinically evaluated independently by 2 calibrated examiners using the California Dental Association protocol. The mean time in function for all restorations at examination was 49 months. Seventy-five (93%) onlays were still in function after 4 years. Six onlays (7.3%) failed; 1 had lost retention as a result of caries, and 5 had fractured. All failures were in molar regions. Ceramic onlay therapy is an acceptable treatment alternative over a 4-year period, but further long-term data are necessary before this treatment should be considered for general dental practice.

  2. Evaluation of different treatment methods against denture stomatitis: a randomized clinical study.

    PubMed

    Tay, Lidia Yileng; Jorge, Janaina Habib; Herrera, Daniel Rodrigo; Campanha, Nara Hellen; Gomes, Brenda Paula; Andre Dos Santos, Fabio

    2014-07-01

    The aim of this clinical study was to determine the efficacy of Uncaria tomentosa (cat's claw) against denture stomatitis (DS). Fifty patients with DS were randomly assigned into 3 groups to receive 2% miconazole, placebo, or 2% U tomentosa gel. DS level was recorded immediately, after 1 week of treatment, and 1 week after treatment. The clinical effectiveness of each treatment was measured using Newton's criteria. Mycologic samples from palatal mucosa and prosthesis were obtained to determinate colony forming units per milliliter (CFU/mL) and fungal identification at each evaluation period. Candida species were identified with HiCrome Candida and API 20C AUX biochemical test. DS severity decreased in all groups (P < .05). A significant reduction in number of CFU/mL after 1 week (P < .05) was observed for all groups and remained after 14 days (P > .05). C albicans was the most prevalent microorganism before treatment, followed by C tropicalis, C glabrata, and C krusei, regardless of the group and time evaluated. U tomentosa gel had the same effect as 2% miconazole gel. U tomentosa gel is an effective topical adjuvant treatment for denture stomatitis. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. Evaluation of metronidazole nanofibers in patients with chronic periodontitis: A clinical study

    PubMed Central

    Chaturvedi, Thakur Prasad; Srivastava, Ruchi; Srivastava, Anand Kumar; Gupta, Varun; Verma, Pushpendra Kumar

    2012-01-01

    Aim: Prevention of periodontal disease progression is the primary goal of periodontal therapy. When conventional therapy is found to be inadequate in achieving periodontal health in chronic periodontitis, local antimicrobial agents are used as an adjunct to scaling and root planing (SRP), which produces encouraging results. In the present study, an attempt was made to develop a low-dose controlled-release delivery system for the treatment of periodontal infections. A new sustained release drug system of poly e-caprolactone (PCL) nanofibers containing metronidazole (MET) was successfully electrospun and evaluated clinically for periodontal diseases. The retentive nanofibres were shown to provide a controlled delivery of the drugs. Materials and Methods: Nanofibers were prepared with MET in PCL by electrospinning technique. The drug-coated nanofibers provided sustained effect up to a period of 11 days (264 h) and followed first-order release. Forty sites in seven patients (four females and three males) with chronic periodontitis (5–8 mm probing depth) were allocated in two experimental treatment groups: Group A treated with SRP + MET nanofibers and Group B treated with SRP alone (control group). All these patients were evaluated clinically for probing depth (PD), plaque index (PI), and gingival index (GI). Results: Both the treatment groups were found to be efficacious in the treatment of periodontal disease as demonstrated by improvement in PD, PI, and GI. Conclusion: Combination of SRP + MET nanofibers (Group A) resulted in added benefits, compared to the control group. PMID:23580938

  4. [Evaluation of clinical trials].

    PubMed

    Ural, Dilek

    2010-03-01

    Women are under-represented in landmark clinical trials that form the basis of evidence based management of cardiovascular diseases. Differences among male and female patients emerged in effectiveness and safety of therapeutics in some diseases. Especially in dyslipidemia, ischemic heart diseases and heart failure, trials in which women are better represented and guidelines that evaluate findings in women more detailed are needed. This article evaluates differences among men and women in some landmark trials that are used among main references in management guidelines.

  5. Combining Methods in Evaluating Information Systems: Case Study of a Clinical Laboratory Information System

    PubMed Central

    Kaplan, Bonnie; Duchon, Dennis

    1989-01-01

    This paper reports how quantitative and qualitative methods were combined in a case study of a clinical laboratory information system. The study assessed effects of the system on work in the laboratories, as reported by laboratory technologists seven months post implementation. Primary changes caused by the computer system were increases in the amount of paperwork performed by technologists and improvements in laboratory results reporting. Individual technologists, as well as laboratories, differed in their assessments of the system according to their perceptions of how it affected their jobs. The combination of qualitative and quantitative data led to the development of a theoretical explanatory model of these differences. The paper discusses methodological implications and the need for an approach to evaluating medical computer systems that takes into account the inter-relationships and processes of which the system is a part.

  6. Evaluation of the Esthetic Properties of Developmental Defects of Enamel: A Spectrophotometric Clinical Study

    PubMed Central

    Guerra, Fabrizio; Mazur, Marta; Corridore, Denise; Pasqualotto, Debora; Nardi, Gianna Maria; Ottolenghi, Livia

    2015-01-01

    Objectives. Detailed clinical quantification of optical properties of developmental defect of enamel is possible with spectrophotometric evaluation. Developmental defects of enamel (DDE) are daily encountered in clinical practice. DDE are an alteration in quality and quantity of the enamel, caused by disruption and/or damage to the enamel organ during amelogenesis. Methods. Several clinical indices have been developed to categorize enamel defects based on their nature, appearance, microscopic features, or cause. A sample of 39 permanent teeth presenting DDE on labial surface was examined using the DDE Modified Index and SpectroShade evaluation. The spectrophotometric approach quantifies L* (luminosity), a* (quantity of green-red), and b* (quantity of blue-yellow) of different DDE. Conclusions. SpectroShade evaluation of the optical properties of the enamel defect enhances clinical understanding of severity and extent of the defect and characterizes the enamel alteration in terms of color discrepancy and surface characterization. PMID:25874260

  7. Evaluation of mineral trioxide aggregate as root canal sealer: A clinical study

    PubMed Central

    Thakur, Sophia; Emil, Jonathan; Paulaian, Benin

    2013-01-01

    Aim: The aim of this study was to compare the clinical and radiological outcome of mineral trioxide aggregate (MTA) or epoxy resin as a root canal sealer compared with zinc oxide eugenol sealer. Materials and Methods: 45 single rooted teeth with periapical index Score 2 or more were allotted to three groups with 15 teeth in each group. Root canal treatment was performed in two visits and obturated with Gutta-percha as obturating material and zinc oxide eugenol as sealer in Group 1, epoxy resin as sealer in Group 2 and MTA mixed with propylene glycol as sealer in Group 3. Visual analog scale, periapical index and VixWin digital Pro image analysis software were used for evaluation. The quantitative data was analyzed by t-test and analysis of variance. Ordinal data was analyzed by Wilcoxon's signed rank test, Mann-Whitney and Kruskall-Wallis test. Results: Results suggested that there exists no statistically significant difference in clinical or radiological outcome of root canal therapy with three different types of sealers used in this study. Conclusions: MTA could be used as a root canal sealer with equal effectiveness compared with epoxy resin and zinc oxide eugenol sealers. Further long-term studies should be carried out to prove the effectiveness. PMID:24347880

  8. Safety Evaluation of CNS Administered Biologics-Study Design, Data Interpretation, and Translation to the Clinic.

    PubMed

    Vuillemenot, Brian R; Korte, Sven; Wright, Teresa L; Adams, Eric L; Boyd, Robert B; Butt, Mark T

    2016-07-01

    Many central nervous system (CNS) diseases are inadequately treated by systemically administered therapies due to the blood brain barrier (BBB), which prevents achieving adequate drug concentrations at sites of action. Due to the increasing prevalence of neurodegenerative diseases and the inability of most systemically administered therapies to cross the BBB, direct CNS delivery will likely play an increasing role in treatment. Administration of large molecules, cells, viral vectors, oligonucleotides, and other novel therapies directly to the CNS via the subarachnoid space, ventricular system, or parenchyma overcomes this obstacle. Clinical experience with direct CNS administration of small molecule therapies suggests that this approach may be efficacious for the treatment of neurodegenerative disorders using biological therapies. Risks of administration into the brain tissue or cerebrospinal fluid include local damage from implantation of the delivery system and/or administration of the therapeutic and reactions affecting the CNS. Preclinical safety studies on CNS administered compounds must differentiate between the effects of the test article, the delivery device, and/or the vehicle, and assess exacerbations of reactions due to combinations of effects. Animal models characterized for safety assessment of CNS administered therapeutics have enabled human trials, but interpretation can be challenging. This manuscript outlines the challenges of preclinical intrathecal/intracerebroventricular/intraparenchymal studies, evaluation of results, considerations for special endpoints, and translation of preclinical findings to enable first-in-human trials. Recommendations will be made based on the authors' collective experience with conducting these studies to enable clinical development of CNS-administered biologics.

  9. Evaluating a Novel Summary Visualization for Clinical Trial Reports: A Usability Study

    PubMed Central

    Tong, Maurine; Hsu, William; Taira, Ricky K.

    2016-01-01

    Contributions of clinical trials are captured in published reports that are unstructured and often require extensive manual review to gain a deeper understanding of the study itself. Our goal is to increase comprehension and decrease the time necessary to understand these reports through the use of visualization tools. In this paper, we specify and evaluate the visualization of a previously developed representation as well as gain insight from user input for further development. The usability experiment consisted of a two-arm study with users either having or not having access to the visualization. A user questionnaire was used to measure time spent and accuracy in comprehension; intuitiveness and reproducibility of the visualization; and preferences. We found that having the visualization required on average 28.1% less time (25.8 min vs. 35.8 min, p=0.01) while maintaining similar accuracy (73.7% vs. 67.0%). Users were then asked to create their own visualizations, with their visualizations averaging 86.1% similar to the gold standard. All participants either preferred the visualization over the status quo or preferred both equally. These results demonstrate that novel visualizations for trial reports could provide time savings and achieve similar accuracy as reviewing the paper itself. Understanding the strength and quality of clinical trials can be alleviated with a visualization that makes content explicit. PMID:28269960

  10. Non-stroke neurological syndromes associated with antiphospholipid antibodies: evaluation of clinical and experimental studies.

    PubMed

    Chapman, J; Rand, J H; Brey, R L; Levine, S R; Blatt, I; Khamashta, M A; Shoenfeld, Y

    2003-01-01

    Although many types of neurological disorders and events have been described in association with antiphospholipid antibodies (aPL) and the antiphospholipid syndrome (APS), only ischaemic stroke is reasonably well established and accepted as a diagnostic criterion for the syndrome. We propose to evaluate, classify and rank the association of other neurological manifestations as possible, probable, or definite according to the data available from clinical studies and animal models. By these criteria, none of the neurological disorders or events such as epilepsy, psychiatric disease, dementia, transverse myelitis, multiple sclerosis-like disease, chorea, migraine, Guillian-Barrè syndrome, and sensory-neural hearing loss, can be definitely associated with aPL or APS.

  11. Spectrophotometric color evaluation of permanent incisors, canines and molars. A cross-sectional clinical study

    PubMed Central

    POP-CIUTRILA, IOANA-SOFIA; COLOSI, HORATIU ALEXANDRU; DUDEA, DIANA; BADEA, MANDRA EUGENIA

    2015-01-01

    Background and aims An accurate color reproduction represents the final validation level of an esthetic anterior or posterior restoration. The aim of this study was to evaluate the color of permanent maxillary incisors, canines and molars, using a clinical spectrophotometer. Methods The Vita Easyshade Advance 4.0® intraoral spectrophotometer was used by one clinician to determine the color of 369 permanent maxillary incisors, canines and molars. The best matches to Vitapan Classical® and 3D-Master® shade guides were recorded. A one-way analysis of variance and Kruskal-Wallis test were used to compare L*, a*, b*, c* and h* color coordinates among the 3 types of teeth. Differences between the mean values of all color coordinates were evaluated by use of Bonferroni corrections. Color difference (ΔE*) between incisors, canines and molars was calculated from ΔL*, Δa* and Δb* data and the results were compared to ΔE*=3.3 acceptability threshold. Results Except for Δa* and Δh* between canines and molars, statistically significant differences among the mean differences of all color coordinates were found when the 3 types of teeth were compared by pairs. The most frequently measured shades were A1 (48.4%), respectively 1M1 (31.5%) for incisors, B3 (36.6%), respectively 2M3 (39.8%) for canines and B3 (44.7%), respectively 2M3 (52%) for molars. Incisors had the highest lightness values, followed by canines and molars. Molars were the most chromatic with the highest a* and b* values. Conclusions Despite the limitations of this study, color differences among incisors, canines and molars were found to be statistically significant, above the clinical acceptability threshold established. In conclusion, successful esthetic restorations of permanent teeth of the same patient need an individual color assessment and reproduction of every type of tooth. PMID:26733753

  12. Binostril versus mononostril approaches in endoscopic transsphenoidal pituitary surgery: clinical evaluation and cadaver study.

    PubMed

    Conrad, Jens; Ayyad, Ali; Wüster, Christian; Omran, Wael; Weber, Matthias M; Konerding, Moritz A; Müller-Forell, Wibke; Giese, Alf; Oertel, Joachim

    2016-08-01

    OBJECTIVE Over the past 2 decades, endoscopy has become an integral part of the surgical repertoire for skull base procedures. The present clinical evaluation and cadaver study compare binostril and mononostril endoscopic transnasal approaches and the surgical techniques involved. METHODS Forty patients with pituitary adenomas were treated with either binostril or mononostril endoscopic surgery. Neurosurgical, endocrinological, ophthalmological, and neuroradiological examinations were performed. Ten cadaver specimens were prepared, and surgical aspects of the preparation and neuroradiological examination were documented. RESULTS In the clinical evaluation, 0° optics were optimal in the nasal and sphenoidal phase of surgery for both techniques. For detection of tumor remnants, 30° optics were superior. The binostril approach was significantly more time consuming than the mononostril technique. The nasal retractor limited maneuverability of instruments during mononostril approaches in 5 of 20 patients. Endocrinological pituitary function, control of excessive hormone secretion, ophthalmological outcome, residual tumor, and rates of adverse events, such as CSF leaks and diabetes insipidus, were similar in both groups. In the cadaver study, there was no significant difference in the time required for dissection via the binostril or mononostril technique. The panoramic view was superior in the binostril group; this was due to the possibility of wider opening of the sella in the craniocaudal and horizontal directions, but the need for removal of more of the nasal septum was disadvantageous. CONCLUSIONS Because of maneuverability of instruments and a wider view in the sphenoid sinus, the binostril technique is superior for resection of large tumors with parasellar and suprasellar expansion and tumors requiring extended approaches. The mononostril technique is preferable for tumors with limited extension in the intra- and suprasellar area.

  13. Molecular microbiological evaluation of passive ultrasonic activation as a supplementary disinfecting step: a clinical study.

    PubMed

    Paiva, Simone S M; Siqueira, José F; Rôças, Isabela N; Carmo, Flávia L; Leite, Deborah C A; Ferreira, Dennis C; Rachid, Caio T C; Rosado, Alexandre S

    2013-02-01

    This in vivo study used molecular microbiology methods to evaluate the effects of passive ultrasonic irrigation (PUI) as a supplementary disinfecting step after root canal preparation. Samples were taken from 10 necrotic root canals of teeth with apical periodontitis before (S1) and after rotary nickel-titanium instrumentation using 2.5% NaOCl as the irrigant (S2) and then after PUI for NaOCl activation (S3). The parameters examined included the incidence of positive broad-range polymerase chain reaction (PCR) results for bacterial presence, the impact on bacterial diversity evaluated by PCR-denaturing gradient gel electrophoresis (DGGE), the quantitative bacterial reduction determined by real-time PCR, and the identification of persistent species by clone library analysis. All S1 samples were positive for bacteria in all tests. Treatment procedures were significantly effective in reducing the incidence of positive results for bacteria, the number of bacterial cells (infectious bioburden), and the bacterial diversity (number of species and abundance). However, the supplementary PUI approach did not succeed in significantly enhancing disinfection beyond that achieved by chemomechanical preparation. Several bacterial species/phylotypes were identified in post-treatment samples that were positive for bacteria. Findings from this clinical study including a small sample size suggest that PUI can be ineffective in significantly improving disinfection of the main root canal after chemomechanical procedures. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  14. Evaluation of Hi-Tec Implant Restoration in Mandibular First Molar Region- A Prospective Clinical Study

    PubMed Central

    Sreeram, Roopa Rani. S.; Prasad, L Krishna; Chakravarthi, P Srinivas; Devi, Naga Neelima; Sreeram, Sanjay Krishna

    2015-01-01

    Background and Aims Missing teeth lead to loss of structural balance, inefficient function, poor aesthetics and psychological effects on human beings, which needs restoration for normal contour, function and aesthetics. Several natural or synthetic substitutes are being used for replacement of missing tooth since centuries. Implants are the latest modality of replacement. So, the study was aimed to assess clinical success rate of Hi-Tec implant; which is economical and new in market. Results of the study will help clinician for appropriate implant selection. Materials and Methods The study included 10 patients from 19 to 31 years and needed restoration of missing mandibular first molar. Restoration had done using Hi Tec Single-tooth implants with metal-ceramic single crown prosthesis after three months of osseointegration. The implants were evaluated clinically (bleeding on probing, probing depth, implant mobility- periotest) and radiographically (marginal bone loss and peri-implant radiolucency) for six years. The observers were blinded for the duration of the study to prevent bias. Results All the patients had uneventful post-surgical healing. No bleeding on probing, Implant mobility, peri-implant radiolucency with minimal marginal bone loss and constant probing depths were observed well within the normal range during follow-up periods. Conclusion Two stage single-tooth Hi Tec implant restoration can be used as a successful treatment modality for replacing mandibular first molar in an economic way. However, these results were obtained after 6 years of follow up with a smaller sample size, so long term multi center studies with a larger sample size is recommended for the predictability of success rate conclusively. PMID:26436053

  15. Prospective study to evaluate the clinical and radiological outcome of patients with scleroderma of the face.

    PubMed

    Careta, Mariana Figueiroa; Leite, Claudia da Costa; Cresta, Fernando; Albino, Jose; Tsunami, Mirian; Romiti, Ricardo

    2013-09-01

    Scleroderma featuring rare connective tissue disease that manifests as skin sclerosis and variable systemic involvement. Two categories of scleroderma are known: systemic sclerosis, characterized by cutaneous sclerosis and visceral involvement and localized scleroderma or morphea which classically presents benign evolution and self-limited, confined to the skin and/or underlying tissue. Recent studies show that the localized form may possibly course with involvement of internal organs and variable morbidity. This study aimed to determine the demographic characteristics, the prevalence of systemic manifestations and laboratory findings, as well as the association with autoimmune diseases, and the evolution of neurological findings, both clinical as brain MRI in patients with scleroderma of the face and its relation with the activity skin. Patients with localized scleroderma with facial involvement were evaluated and underwent neurological examination, magnetic resonance imaging and ophthalmology evaluation. After 3years, the patients were subjected again to MRI. We studied 12 patients with localized scleroderma of the face. Of this total, headache being the most frequent complaint found in 66.7% of patients, 33.3% had neurological changes possibly associated with scleroderma. As for ophthalmologic evaluation, 25% of patients showed abnormalities. The most frequent parenchymal finding was the presence of lesions with hyperintense or hypointense signal in 75% of patients, followed by ventricular asymmetry at 16.7%. Of the patients who had neurological deficits, 75% also had a change to MRI. In all patients, imaging findings after 3years were unchanged. During this interval of 3years, 25% of patients showed signs of activity of scleroderma. Patients with localized scleroderma of the face have a high prevalence of neurological and ophthalmological changes. Based on these findings, we suggest that all cases of localized scleroderma of the face should be thoroughly

  16. Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE).

    PubMed

    Paquette-Warren, Jann; Harris, Stewart B; Naqshbandi Hayward, Mariam; Tompkins, Jordan W

    2016-10-01

    Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real-world evaluation. Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real-world comprehensive evaluations in health care settings. The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub-steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built-in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale-up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. © 2016 The Authors. Journal of Evaluation in Clinical Practice published by John Wiley & Sons, Ltd.

  17. Educating Parents About Pediatric Research: Children and Clinical Studies Website Qualitative Evaluation.

    PubMed

    Marceau, Lisa D; Welch, Lisa C; Pemberton, Victoria L; Pearson, Gail D

    2016-07-01

    A gap in information about pediatric clinical trials exists, and parents remain uncertain about what is involved in research studies involving children. We aimed to understand parent perspectives about pediatric clinical research after viewing the online Children and Clinical Studies (CaCS) program. Using a qualitative descriptive study design, we conducted focus groups with parents and phone interviews with physicians. Three themes emerged providing approaches to improve parent's understanding of clinical research by including strategies where parents (a) hear from parents like themselves to learn about pediatric research, (b) receive general clinical research information to complement study-specific details, and (c) are provided more information about the role of healthy child volunteers. Parents found the website a valuable tool that would help them make a decision about what it means to participate in research. This tool can assist parents, providers, and researchers by connecting general information with study-specific information.

  18. Evaluation of incidence rates in pre-clinical studies using a Williams-type procedure.

    PubMed

    Hothorn, Ludwig A; Sill, Martin; Schaarschmidt, Frank

    2010-01-01

    The analysis of dose-response relationships is a common problem in pre-clinical studies. For example, proportions such as mortality rates and histopathological findings are of particular interest in repeated toxicity studies. Commonly applied designs consist of an untreated control group and several, possibly unequally spaced, dosage groups. The Williams test can be formulated as a multiple contrast test and is a powerful option to evaluate such data. In this paper, we consider simultaneous inference for Williams-type multiple contrasts when the response variable is binomial and sample sizes are only moderate. Approximate simultaneous confidence limits can be constructed using the quantiles of a multivariate normal distribution taking the correlation into account. Alternatively, multiplicity-adjusted p-values can be calculated as well. A simulation study shows that a simple correction based on adding pseudo observations leads to acceptable performance for moderate sample sizes, such as 40 per group. In addition, the calculation of adjusted p-values and approximate power is presented. Finally, the proposed methods are applied to example data from two toxicological studies; the methods are available in an R-package.

  19. Clinical studies with disposable diapers containing absorbent gelling materials: evaluation of effects on infant skin condition.

    PubMed

    Campbell, R L; Seymour, J L; Stone, L C; Milligan, M C

    1987-12-01

    Disposable infant diapers with absorbent gelling material (cross-linked sodium polyacrylates) incorporated into the core were clinically evaluated for their effect on infant skin condition. Absorbent gelling materials tightly hold water and provide pH control by a buffering capacity as well as by helping to segregate urine apart from feces. Four clinical studies were conducted with each following a rigid protocol that controlled for variables of diet and age in addition to the diaper material that may influence the development of diaper dermatitis and helped to control for any inherent bias in the study. This allowed for the controlled assessment of skin condition with respect to diaper type. Absorbent gelling material-containing disposable, conventional (100% cellulose core) disposable, and home-laundered cloth diapers were test products. In these studies 1614 infants were initially enrolled with 522 of them assigned to absorbent gelling material disposable, 738 to conventional disposable, and 354 to home-laundered cloth diapers. Objective measurements of skin wetness (transepidermal water loss) and skin pH, as well as double-blind grading of diaper dermatitis, were the measures of skin condition. Absorbent gelling material disposable diapers were associated with significantly reduced skin wetness, closer to normal skin pH, and lower degrees of diaper dermatitis when compared to conventional disposable or home-laundered cloth diapers. The results are consistent with the hypothesis that better control in the diaper area of skin wetness, skin pH, and the prevention of the mixing of urine and feces produces a better diaper environment.

  20. A comparison of magnetic resonance imaging with electrodiagnostic findings in the evaluation of clinical radiculopathy: a cross-sectional study.

    PubMed

    Reza Soltani, Zahra; Sajadi, Simin; Tavana, Behrooz

    2014-04-01

    The aim of this study was to evaluate the agreement of magnetic resonance imaging and electrodiagnostic studies by comparing their findings in patients with clinically suspected radiculopathy. The agreements between these two procedures and clinical findings were also examined. In a 2-year cross-sectional study, a total of 114 patients with clinically suspected cervical or lumbosacral radiculopathy were included. The total agreements between clinical with MRI and EDX findings were 72 and 52%, respectively while their agreements were similar in group definite (89 vs. 82%). The agreement between EDX and MRI was 59.6 in total and 49% with respect to clinical findings. This study further supports that these two methods are complementary in general. It is reasonable to add EDX when there is discrepancy between MRI and clinical findings or when MRI neurologic findings are not visible.

  1. Evaluation of Interspinous Spacer Outcomes in Degenerative Lumbar Canal Stenosis: Clinical Study.

    PubMed

    Abdel Ghany, Walid; Amer, Aboubakr; Saeed, Khaled; Emara, Essam; Hamad, Ahmad; Nosseir, Mohamed; Dawood, Osama; Nada, Mohamed A

    2016-11-01

    Lumbar spinal stenosis is a common diagnosis in elderly individuals, and the rates of surgery have risen all over the world. The optimal approach to provide satisfactory decompression and minimize complications for lumbar spinal stenosis remains controversial. The purpose of this study was to evaluate the surgical outcome of interspinous spacers versus decompressive laminectomy in the management of degenerative lumbar canal stenosis. Our prospective, comparative study included 2 groups of patients who were operated on in Ain Shams University Hospitals between January 2010 and December 2014. In the first group, 28 patients underwent decompression and additional implantation of an interspinous spacer (ISP). In the second group, 25 patients underwent decompressive laminectomy (DL). Our statistical results revealed no significant difference in outcome between the 2 groups regarding visual analog scale score for leg pain and Oswestry Low Back Pain Disability Index. However, the improvement (visual analog scale score) for back pain was better in the DL group. Complication and reoperation rates were higher in the ISP group. Although decompression and additional implantation of an ISP are safe procedures, they do not show better improvement in clinical outcome as compared with decompressive laminectomy. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Evaluation of the CHUMS Child Bereavement Group: A Pilot Study Examining Statistical and Clinical Change.

    PubMed

    Siddaway, Andy P; Wood, Alex M; Schulz, Joerg; Trickey, David

    2015-01-01

    This article describes the largest evaluation of a UK child bereavement service to date. Change was assessed using conventional statistical tests as well as clinical significance methodology. Consistent with the fact that the intervention was offered on a universal, preventative basis, bereaved young people experienced a statistically significant, small to medium-sized decrease in symptoms over time. This change was equivalent across child age and gender. Type of bereavement had a slight impact on change when rated by parents. Potential clinical implications are highlighted, and various limitations are discussed that we hope to address using an experimental design in future research.

  3. Post-Reteplase Evaluation of Clinical Safety & Efficacy in Indian Patients (Precise-In Study).

    PubMed

    Singh, R K; Trailokya, A; Naik, M M

    2015-04-01

    ST elevated myocardial infarction is a serious and life-threatening condition. In patients suitable for thrombolytic treatment, time is critical and reperfusion should be initiated as soon as possible. Reteplase is commonly used in the management of ST elevated myocardial infarction. To assess the safety and efficacy of intravenous Retelex (Reteplase) injection in management of patients with ST elevated myocardial infarction in clinical practice. An open label, non-comparative, multicentric, post-marketing observational study was conducted in > 18 years of patients with ST elevated myocardial infarction (STEMI) receiving Retelex. All patients received 20 units Retelex within 6 hours after the onset of acute myocardial infarction (AMI) symptoms. The dose was given as two 10 unit Intravenous injections each over two minutes 30 minutes apart. Evaluation criteria: Patients were followed on day 1, 3, 5/7 and 30. The primary evaluation criteria was total number of patients showing clinically successful thrombolysis based on 50% resolution of ST-elevation in the maximum affected (adjacent) leads within 90-120 minutes of initiation of Reteplase and resolution of chest pain. Secondary evaluation criteria included percentage of patient requiring rescue percutaneous coronary intervention (PCI), percentage of patient underwent angioplasty or CABG after thrombolysis. Door to needle time was also recorded in patients receiving the study drug. Global assessment of efficacy and safety was done by patient as well as investigator. All adverse events were recorded for safety assessment. Statistical analysis: Mean and percentage were calculated for primary efficacy parameters i.e. 50% resolution of ST elevation and resolution of chest pain. Chi square test was used for comparing the difference between diabetes versus non-diabetes patients for primary efficacy variables as well as for comparing the number of patients requiring rescue PCI, angioplasty and CABG between these two groups

  4. Clinical evaluation of the use of a multifunctional remotely controlled insulin pump: multicenter observational study.

    PubMed

    Boizel, Robert; Pinget, Michel; Lachgar, Karim; Parkin, Christopher G; Grulet, Hervé; Guillon-Metz, Françoise; Weissmann, Joerg

    2014-11-01

    Current insulin pumps now feature advanced functions for calculating insulin dosages, delivering insulin and analyzing data, however, the perceived usefulness of these functions in clinical settings has not been well studied. We assessed the use and patient perceptions of an insulin delivery system (Accu-Chek® Combo, Roche Diagnostics, Mannheim, Germany) that combines an insulin pump and a handheld multifunctional blood glucose meter with integrated remote control functions. This prospective, observational, multicenter study enrolled 74 type 1 diabetes patients within 13 weeks after starting use of the pump system. At 4 to 24 weeks, investigators collected usage data from the latest 14-day period. Seventy-two patients completed the evaluation, aged 39 ± 15 years, diabetes duration 16 ± 13 years, HbA1c 8.3 ± 1.6%. At follow-up, 62 (86.1%) patients used the remote control for ≥50% of all boluses, 20 (27.8%) used the bolus advisor for ≥50% of all boluses, and 42 (58.3%) viewed at least 1 of the e-logbook reports. More than 95% of users appraised the functions as easy-to-use and useful; median scores from VAS (0 = useless to 100 = indispensable) ranged from 72 to 85. A high percentage of study patients used the system's advanced features, especially the remote control feature for bolusing. Overall, patients assessed the functions as useful and easy to use. Results support the implementation of these smart capabilities in further insulin pump developments. © 2014 Diabetes Technology Society.

  5. Betamethasone: A dermatological clinical evaluation.

    PubMed

    DANTO, J L; STEWART, W D; MADDIN, W S; NELSON, A J

    1963-03-30

    The purpose of this study was to determine under carefully controlled clinical conditions the relative anti-inflammatory and anti-pruritic action of betamethasone as compared with prednisone and a placebo. A total of 130 consecutive patients with atopic dermatitis, primary irritant dermatitis, nummular eczema, allergic eczematous contact dermatitis, sweat retention, seborrheic dermatitis and pruritus were selected for study. Under the conditions of this clinical trial, the samples indicated a difference in anti-inflammatory and anti-pruritic response to the therapeutic agents used. The difference between betamethasone and the placebo was highly significant, and the difference in these measured responses was studied on the basis of a careful evaluation and statistically. The result of this study corroborates statistically our clinical impression regarding the therapeutic effect of betamethasone.

  6. Betamethasone: A Dermatological Clinical Evaluation

    PubMed Central

    Danto, J. L.; Stewart, W. D.; Maddin, W. S.; Nelson, A. J.

    1963-01-01

    The purpose of this study was to determine under carefully controlled clinical conditions the relative anti-inflammatory and anti-pruritic action of betamethasone as compared with prednisone and a placebo. A total of 130 consecutive patients with atopic dermatitis, primary irritant dermatitis, nummular eczema, allergic eczematous contact dermatitis, sweat retention, seborrheic dermatitis and pruritus were selected for study. Under the conditions of this clinical trial, the samples indicated a difference in anti-inflammatory and anti-pruritic response to the therapeutic agents used. The difference between betamethasone and the placebo was highly significant, and the difference in these measured responses was studied on the basis of a careful evaluation and statistically. The result of this study corroborates statistically our clinical impression regarding the therapeutic effect of betamethasone. PMID:14025047

  7. Respiratory infections: clinical evaluation.

    PubMed

    Grassi, C

    1985-01-01

    A review of clinical studies of piperacillin shows that it is valuable for the treatment of respiratory infections due to Enterobacteriaceae, Pseudomonas sp, anaerobes, and mixed flora including anaerobes. Various studies of a total of 420 patients treated with piperacillin for lower respiratory tract infections found that 97% of the patients were cured or markedly improved. Piperacillin has also been found as effective as combination therapy (gentamicin or tobramycin plus carbenicillin or ticarcillin) in the treatment of serious infections, including pneumonia and several caused by gram-negative organisms and anaerobic organisms. A review of the literature on bacteriological responses to piperacillin shows that 126 of 153 (82%) of the susceptible strains could be eradicated. Streptococcus pneumoniae, beta-hemolytic streptococci, Haemophilus influenzae, Peptostreptococcus sp, Bacteroides sp, and Fusobacterium sp have been completely eradicated by treatment with piperacillin. Most of the published studies indicate that therapy with the drug is usually well tolerated.

  8. Design of a Competency Evaluation Model for Clinical Nursing Practicum, Based on Standardized Language Systems: Psychometric Validation Study.

    PubMed

    Iglesias-Parra, Maria Rosa; García-Guerrero, Alfonso; García-Mayor, Silvia; Kaknani-Uttumchandani, Shakira; León-Campos, Álvaro; Morales-Asencio, José Miguel

    2015-07-01

    To develop an evaluation system of clinical competencies for the practicum of nursing students based on the Nursing Interventions Classification (NIC). Psychometric validation study: the first two phases addressed definition and content validation, and the third phase consisted of a cross-sectional study for analyzing reliability. The study population was undergraduate nursing students and clinical tutors. Through the Delphi technique, 26 competencies and 91 interventions were isolated. Cronbach's α was 0.96. Factor analysis yielded 18 factors that explained 68.82% of the variance. Overall inter-item correlation was 0.26, and total-item correlation ranged between 0.66 and 0.19. A competency system for the nursing practicum, structured on the NIC, is a reliable method for assessing and evaluating clinical competencies. Further evaluations in other contexts are needed. The availability of standardized language systems in the nursing discipline supposes an ideal framework to develop the nursing curricula. © 2015 Sigma Theta Tau International.

  9. Accuracy evaluation of intraoral optical impressions: A clinical study using a reference appliance.

    PubMed

    Atieh, Mohammad A; Ritter, André V; Ko, Ching-Chang; Duqum, Ibrahim

    2017-09-01

    Trueness and precision are used to evaluate the accuracy of intraoral optical impressions. Although the in vivo precision of intraoral optical impressions has been reported, in vivo trueness has not been evaluated because of limitations in the available protocols. The purpose of this clinical study was to compare the accuracy (trueness and precision) of optical and conventional impressions by using a novel study design. Five study participants consented and were enrolled. For each participant, optical and conventional (vinylsiloxanether) impressions of a custom-made intraoral Co-Cr alloy reference appliance fitted to the mandibular arch were obtained by 1 operator. Three-dimensional (3D) digital models were created for stone casts obtained from the conventional impression group and for the reference appliances by using a validated high-accuracy reference scanner. For the optical impression group, 3D digital models were obtained directly from the intraoral scans. The total mean trueness of each impression system was calculated by averaging the mean absolute deviations of the impression replicates from their 3D reference model for each participant, followed by averaging the obtained values across all participants. The total mean precision for each impression system was calculated by averaging the mean absolute deviations between all the impression replicas for each participant (10 pairs), followed by averaging the obtained values across all participants. Data were analyzed using repeated measures ANOVA (α=.05), first to assess whether a systematic difference in trueness or precision of replicate impressions could be found among participants and second to assess whether the mean trueness and precision values differed between the 2 impression systems. Statistically significant differences were found between the 2 impression systems for both mean trueness (P=.010) and mean precision (P=.007). Conventional impressions had higher accuracy with a mean trueness of 17.0

  10. An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model study.

    PubMed

    Li, Jing-Xian; Qiao, Zhi-Cheng; Ma, Hong-Xia; Li, Yi-Ting; Li, En-Chang; Ji, Peng-Cheng; Huang, Gang

    2017-06-01

    To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China. Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM), higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology. Data were processed in SPSS 13.0 and Lisre l5.3. There were 52 third class indices, 15 second class indices, and 3 first class indices in this ethical evaluation index system. The weight of each index was calculated by normalisation. This study developed a three-level ethical evaluation index system, comprising 70 indices, for the clinical approval of medical technology.

  11. Clinical study evaluating the accuracy of injecting the distal tarsal joints in the horse.

    PubMed

    Seabaugh, K A; Selberg, K T; Mueller, P O E; Eggleston, R B; Peroni, J F; Claunch, K M; Markwell, H J; Baxter, G M

    2017-09-01

    Osteoarthritis (OA) of the centrodistal (CD) and tarsometatarsal (TMT) joints is a common cause of lameness in horses. Intra-articular diagnostic anaesthesia and/or therapeutic injection are relied upon to help diagnose and treat many horses with OA of these joints. The objective of this study was to determine the accuracy of arthrocentesis of the CD and TMT joints using a sample population of equine surgeons and surgery residents. Randomised experimental study. Six operators each injected four CD and four TMT joints in 12 sedated horses. The operators were randomly assigned to inject either the left CD and right TMT or the right CD and left TMT on four randomly assigned horses. The joints were injected with a 4 ml solution of contrast medium (2 ml), sterile saline (1.5 ml) and amikacin (0.5 ml). A minimum of two radiographs of each joint was obtained to evaluate the presence of contrast medium within the target joint. The TMT joint was successfully injected in 23/24 joints (96% accuracy). The CD joint was successfully injected in 10/24 joints (42% accuracy). Communication between the TMT and CD joints was visible in 26% of successful TMT injections. Communication between the CD and TMT joints was visible in 20% of successful CD injections. Despite specific requests to do so, we were unable to standardise the injection technique across all operators. The accuracy of injecting the TMT and CD joints of sedated horses was 96 and 42%, respectively. The CD joint was frequently missed with contrast medium being placed in the periarticular tissues. These data support the clinical impression of the difficulty of injecting the CD joint and suggests that practitioners should utilise ancillary methods, such as radiographs, to ensure proper needle placement. © 2017 EVJ Ltd.

  12. Evaluation of Employee Vaccination Policies in Outpatient Oncology Clinics: A Pilot Study.

    PubMed

    Luthy, Karlen E; Stocksdale, Sarah L; Macintosh, Janelle L B; Eden, Lacey M; Beckstrand, Renea L; Edmonds, Katie

    2016-10-01

    All major hospital facilities in the state of Utah have employee vaccination policies. However, the presence of healthcare worker vaccination policies in outpatient oncology clinics was unknown. The objectives of this article are to identify oncology outpatient employee vaccination policies in Utah and to identify what consequences, if any, are present for unvaccinated employees. This was a cross-sectional, descriptive study design in which clinic managers from outpatient oncology clinics were asked, via questionnaire, to describe the clinic's employee vaccination policy and the consequences for refusing the policy. Most vaccination policies applied to employees primarily assigned to work in the direct patient care area. Most commonly, influenza and hepatitis B vaccines were required as part of the vaccination policy. Most managers offered free vaccinations to employees, but most managers also allowed employees to refuse to follow the vaccination policy for medical, religious, or personal reasons.

  13. Overview of registered studies in orthodontics: Evaluation of the ClinicalTrials.gov registry.

    PubMed

    Allareddy, Veerasathpurush; Rampa, Sankeerth; Masoud, Mohamed I; Lee, Min Kyeong; Nalliah, Romesh; Allareddy, Veerajalandhar

    2014-11-01

    The Food and Drug Administration Modernization Act of 1997 made it mandatory for all phase II through IV trials regulated by this Act to be registered. After this, the National Institutes of Health created ClinicalTrials.gov, which is a registry of publicly and privately supported clinical studies of human participants. The objective of this study was to examine the characteristics of registered studies in orthodontics. The ClinicalTrials.gov Web site was used to query all registered orthodontic studies. The search term used was "orthodontics." No limitations were placed for the time period. All registered studies regardless of their recruitment status, study results, and study type were selected for analysis. A total of 64 orthodontic studies were registered as of January 1, 2014. Of these, 52 were interventional, and 12 were observational. Close to 60% of the interventional studies and 66.7% of the observational studies had sample sizes of 50 or fewer subjects. About 21.2% of the interventional studies and 16.7% of the observational studies had sample sizes greater than 100. Only 1 study was funded by the National Institutes of Health, and the rest were funded by "other" or "industry" sources. Close to 87.7% of the interventional studies were randomized. Interventional model assignments included factorial assignment (3.9%), parallel assignments (74.5%), crossover assignment (7.8%), and single-group assignment (13.7%). Most studies were treatment oriented (80.4%). The types of masking used by the interventional studies included open label (28.9%), single blind (44.2%), and double blind (26.9%). Outcome assessors were blinded in only 6 studies. Orthodontic studies registered in ClinicalTrials.gov are dominated by small single-center studies. There are wide variations with regard to treatment allocation approaches and randomization methods in the studies. These results also indicate the need for multicenter clinical studies in orthodontics. Copyright © 2014

  14. Evaluation of the clinical process in a critical care information system using the Lean method: a case study

    PubMed Central

    2012-01-01

    Background There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. Methods We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. Results We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. Conclusions The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy. PMID:23259846

  15. Evaluation of the clinical process in a critical care information system using the Lean method: a case study.

    PubMed

    Yusof, Maryati Mohd; Khodambashi, Soudabeh; Mokhtar, Ariffin Marzuki

    2012-12-21

    There are numerous applications for Health Information Systems (HIS) that support specific tasks in the clinical workflow. The Lean method has been used increasingly to optimize clinical workflows, by removing waste and shortening the delivery cycle time. There are a limited number of studies on Lean applications related to HIS. Therefore, we applied the Lean method to evaluate the clinical processes related to HIS, in order to evaluate its efficiency in removing waste and optimizing the process flow. This paper presents the evaluation findings of these clinical processes, with regards to a critical care information system (CCIS), known as IntelliVue Clinical Information Portfolio (ICIP), and recommends solutions to the problems that were identified during the study. We conducted a case study under actual clinical settings, to investigate how the Lean method can be used to improve the clinical process. We used observations, interviews, and document analysis, to achieve our stated goal. We also applied two tools from the Lean methodology, namely the Value Stream Mapping and the A3 problem-solving tools. We used eVSM software to plot the Value Stream Map and A3 reports. We identified a number of problems related to inefficiency and waste in the clinical process, and proposed an improved process model. The case study findings show that the Value Stream Mapping and the A3 reports can be used as tools to identify waste and integrate the process steps more efficiently. We also proposed a standardized and improved clinical process model and suggested an integrated information system that combines database and software applications to reduce waste and data redundancy.

  16. The Diagnosis of Urinary Tract Infection in Young Children (DUTY) Study Clinical Rule: Economic Evaluation.

    PubMed

    Hollingworth, William; Busby, John; Butler, Christopher C; O'Brien, Kathryn; Sterne, Jonathan A C; Hood, Kerenza; Little, Paul; Lawton, Michael; Birnie, Kate; Thomas-Jones, Emma; Harman, Kim; Hay, Alastair D

    2017-04-01

    To estimate the cost-effectiveness of a two-step clinical rule using symptoms, signs and dipstick testing to guide the diagnosis and antibiotic treatment of urinary tract infection (UTI) in acutely unwell young children presenting to primary care. Decision analytic model synthesising data from a multicentre, prospective cohort study (DUTY) and the wider literature to estimate the short-term and lifetime costs and healthcare outcomes (symptomatic days, recurrent UTI, quality adjusted life years) of eight diagnostic strategies. We compared GP clinical judgement with three strategies based on a 'coefficient score' combining seven symptoms and signs independently associated with UTI and four strategies based on weighted scores according to the presence/absence of five symptoms and signs. We compared dipstick testing versus laboratory culture in children at intermediate risk of UTI. Sampling, culture and antibiotic costs were lowest in high-specificity DUTY strategies (£1.22 and £1.08) compared to clinical judgement (£1.99). These strategies also approximately halved urine sampling (4.8% versus 9.1% in clinical judgement) without reducing sensitivity (58.2% versus 56.4%). Outcomes were very similar across all diagnostic strategies. High-specificity DUTY strategies were more cost-effective than clinical judgement in the short- (iNMB = £0.78 and £0.84) and long-term (iNMB =£2.31 and £2.50). Dipstick tests had poorer cost-effectiveness than laboratory culture in children at intermediate risk of UTI (iNMB = £-1.41). Compared to GPs' clinical judgement, high specificity clinical rules from the DUTY study could substantially reduce urine sampling, achieving lower costs and equivalent patient outcomes. Dipstick testing children for UTI is not cost-effective. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  17. Clinical evaluation study of the German network of disorders of sex development (DSD)/intersexuality: study design, description of the study population, and data quality

    PubMed Central

    Lux, Anke; Kropf, Siegfried; Kleinemeier, Eva; Jürgensen, Martina; Thyen, Ute

    2009-01-01

    Background The German Network of Disorders of Sex Development (DSD)/Intersexuality carried out a large scale clinical evaluation study on quality of life, gender identity, treatment satisfaction, coping, and problems associated with diagnoses and therapies in individuals with disorders of sex development (DSD). DSD are a heterogeneous group of various genetic disorders of sex determination or sex differentiation, all of which are rare conditions. In about half of all cases the molecular genetic diagnosis is unknown and diagnosis rests on clinical features. Methods and design The multi-centre clinical evaluation study includes short-term follow-up in some and cross-sectional assessments in all age and diagnostic groups fitting the criteria of DSD. Recruitment was from January 2005 until December 2007 in whole Germany and, additionally, in 2007 in Austria and German-speaking Switzerland. The study consists of a psychosocial inquiry for children, adolescents and their parents, and adults with standardized instruments and the collection of DSD-specific medical data by the attending physician. The main goal was the description of clinical outcomes and the health-care situation of individuals with DSD using a broad generic definition of DSD including all conditions with a mismatch of chromosomal, gonadal and phenotypical sex. 439 children and adolescents, their parents and adults with DSD participated. Discussion The clinical evaluation study represents the most comprehensive study in this clinical field. The paper discusses the study protocol, the data management and data quality as well as the classification used, and it describes the study population. Given the lack of large datasets in rare conditions such as DSD and often biased results from small scale clinical case series, the study aims to generate concrete hypotheses for evidence-based guidelines, which should be tested in further studies. PMID:19383134

  18. A qualitative study evaluating causality attribution for serious adverse events during early phase oncology clinical trials.

    PubMed

    Mukherjee, Som D; Coombes, Megan E; Levine, Mitch; Cosby, Jarold; Kowaleski, Brenda; Arnold, Andrew

    2011-10-01

    In early phase oncology trials, novel targeted therapies are increasingly being tested in combination with traditional agents creating greater potential for enhanced and new toxicities. When a patient experiences a serious adverse event (SAE), investigators must determine whether the event is attributable to the investigational drug or not. This study seeks to understand the clinical reasoning, tools used and challenges faced by the researchers who assign causality to SAE's. Thirty-two semi-structured interviews were conducted with medical oncologists and trial coordinators at six Canadian academic cancer centres. Interviews were recorded and transcribed verbatim. Individual interview content analysis was followed by thematic analysis across the interview set. Our study found that causality assessment tends to be a rather complex process, often without complete clinical and investigational data at hand. Researchers described using a common processing strategy whereby they gather pertinent information, eliminate alternative explanations, and consider whether or not the study drug resulted in the SAE. Many of the interviewed participants voiced concern that causality assessments are often conducted quickly and tend to be highly subjective. Many participants were unable to identify any useful tools to help in assigning causality and welcomed more objectivity in the overall process. Attributing causality to SAE's is a complex process. Clinical trial researchers apply a logical system of reasoning, but feel that the current method of assigning causality could be improved. Based on these findings, future research involving the development of a new causality assessment tool specifically for use in early phase oncology clinical trials may be useful.

  19. The methodological quality of economic evaluations of guideline implementation into clinical practice: a systematic review of empiric studies.

    PubMed

    Hoomans, Ties; Evers, Silvia M A A; Ament, André J H A; Hübben, Mariette W A; van der Weijden, Trudy; Grimshaw, Jeremy M; Severens, Johan L

    2007-01-01

    Despite the emphasis on efficiency of health-care services delivery, there is an imperfect evidence base to inform decisions about whether and how to develop and implement guidelines into clinical practice. In general, studies evaluating the economics of guideline implementation lack methodological rigor. We conducted a systematic review of empiric studies to assess advances in the economic evaluations of guideline implementation. The Cochrane Effective Professional and Organisational Change Group specialized register and the MEDLINE database were searched for English publications between January 1998 and July 2004 that reported objective effect measures and implementation costs. We extracted data on study characteristics, quality of study design, and economic methodology. It was assessed whether the economic evaluations followed methodological guidance. We included 24 economic evaluations, involving 21 controlled trials and three interrupted time series designs. The studies involved varying settings, targeted professionals, targeted behaviors, clinical guidelines, and implementation strategies. Overall, it was difficult to determine the quality of study designs owing to poor reporting. In addition, most economic evaluations were methodologically flawed: studies did not follow guidelines for evaluation design, data collection, and data analysis. The increasing importance of the value for money of providing health care seems to be reflected by an increase in empiric economic evaluations of guideline implementation. Because of the heterogeneity and poor methodological quality of these studies, however, the resulting evidence is still of limited use in decision-making. There seems to be a need for more methodological guidance, especially in terms of data collection and data synthesis, to appropriately evaluate the economics of developing and implementing guidelines into clinical practice.

  20. [New strategies in the clinical evaluation of patients with colon cancer based on molecular studies].

    PubMed

    Panduro, A; Morales, L; Santos, A; Valdés, L; Lima, G; Meléndez, J; Cabrera, G; Maldonado, V; Villalobos, J J

    1993-01-01

    During the last five years molecular studies allowed important advances in the knowledge of cancer colon with important clinical implications. The main finding was the identification and sequence analysis of the APC gen. Structural alterations of this gene have been detected in patients with Familial Adenomatous Polyposis and Gardner syndrome, which suggest a common disease. Furthermore, alterations of the APC gen appears to be also altered in cases of cancer of colon sporadic. Indicating that structural alteration of the APC gen can be inherited and/or acquired. Restriction fragment-length polymorphisms in the chromosome 5q21-22 can now be used clinically for premorbid diagnosis and counseling in familial adenomatous polyposis. The molecular studies allow the clinician to have a new approach in the management and screening of families with familial adenomatous polyposis. The sequence analysis and specific identification of the structural alteration of the APC gene is a more expensive and sophisticated study, although represent a more direct approach. In the Department of Gastroenterology of the INNSZ we are performing such molecular studies. The main purpose of our group is to proportionate integral clinical-molecular studies for families with hereditary colon cancer, create a national register of these diseases and investigate the molecular bases in order to generate new molecular diagnosis tools.

  1. [Post-marketing clinical study of traditional Chinese medicine--lessons learned from comprehensive evaluation of Fufang Zaoren capsule].

    PubMed

    Qing, Shan; Gao, Lin; Zhang, Li; Jia, Jian-Ping; Liu, Xin-Min; Ji, Shao-Liang; Yang, Xiao-Hui

    2013-11-01

    By comprehensive review and analysis of post-marketing clinical research on the efficacy and safety,we concluded that Fufang Zaoren capsule has certain therapeutic effects for insomnia, although current clinical research design needs improving. The post-marketing clinical studies also showed that it causes several adverse reactions at the recommended doses, such as chills, fever, dizziness, nausea, shortness of breath, chest tightness and palpitations, whereas high doses of Fufang Zaoren capsule can cause delayed extrapyramidal symptoms. Health Canada government website also prompted the L-tetrahydropalmatine in Fufang Zaoren capsule caused liver damage in pregnant women. The authors summarized the risk points, factors and risk control in the clinical use of Fufang Zaoren capsule and also present their perspective on the research status, existing problems and corresponding countermeasures in the post-marketing clinical re-evaluation of traditional Chinese medicine.

  2. Comparative clinical evaluation of transcutaneous electrical nerve stimulator over conventional local anesthesia in children seeking dental procedures: A clinical study.

    PubMed

    Varadharaja, M; Udhya, J; Srinivasan, Ila; Sivakumar, Jambai Sampath Kumar; Karthik, Ramasamy Sundararajan; Manivanan, M

    2014-07-01

    The aim of this study to evaluate the effectiveness of pain control by employing transcutaneous electrical nerve stimulator (TENS) over conventional injectable local anesthesia for children requiring restorative procedures under rubber dam. The study design considered was the split mouth design, in experiment (right) side, dental procedures under rubber dam was performed under TENS and in control (left) side, dental procedures under rubber dam was performed under conventional injectable local anesthetic (LA). The level of comfort and discomfort experienced during TENS and conventional LA was determined using visual analog scale (VAS) and heart rate. Increase in mean heart rate associated with TENS (0.78%) was significantly less compared to increase in heart rate with administration of conventional local anesthesia (11.78%). In VAS, the mean values for pain indicate that minimum pain was felt with TENS, which was closely followed by LA. TENS can offer many safer and psychological advantages and is a valuable alternative to conventional LA for children.

  3. Evaluation of factors predicting clinical pleural injury during percutaneous nephrolithotomy: a prospective study.

    PubMed

    Sharma, Kuldeep; Sankhwar, Satya Narayan; Singh, Vishwajeet; Singh, Bhupendra Pal; Dalela, Diwakar; Sinha, Rahul Janak; Kumar, Manoj; Singh, Manmeet; Goel, Apul

    2016-06-01

    The purpose of this study is to prospectively identify factors that predict the chance of pleural injury (detected clinically or on postoperative X-ray chest) during percutaneous nephrolithotomy (PCNL). All patients with renal/upper ureteric stones, undergoing PCNL between January 2013 and June 2014, were evaluated for pleural injury. An erect chest X-ray on inspiration was done within 6 h of PCNL. The patients were divided into Groups A and B depending on whether they developed or did not develop pleural injury. Patient-, stone-, renal-, and procedure-related factors were compared between the two groups. 332 patients with mean age 36.76 ± 15.01 years (range 4-80) and M:F of 172:160 fulfilled the inclusion criteria. Pleural complications occurred in 10 patients (3 %). Of 141 patients with supracostal punctures (59 had additional infracostal punctures), 4.2 % (n = 6) had pleural injury. Of 191 patients with only infracostal punctures, 4 developed pleural injuries (2 %). Patients in group A had significantly lower age (27.00 ± 11.18 vs. 37.06 ± 15.03, p = 0.03) and lower BMI (18.0 ± 1.90 vs. 21.12 ± 2.24 p = 0.002). Incidence of pleural injury was significantly higher (p = 0.001) on right side [4.0 % (7/172) vs. 1.8 %, 3/160)]. Incidence of pleural injury had no association with staghorn calculi, stone surface area (590.51 ± 313.88 for Group A vs. 593.02 ± 387.10 for Group B; p = 0.11), degree of hydronephrosis, and operative time (65.13 ± 19.45 for Group A vs. 72.21 ± 19.56 for Group B; p = 0.06). On multivariate analysis, only low BMI and mean age <27 years were associated with higher risk of pleural injury. Higher incidence of pleural injury was noted in patients with low BMI and younger age.

  4. Clinical report--guidelines for the ethical conduct of studies to evaluate drugs in pediatric populations.

    PubMed

    Shaddy, Robert E; Denne, Scott C

    2010-04-01

    The proper ethical conduct of studies to evaluate drugs in children is of paramount importance to all those involved in these types of studies. This report is an updated revision to the previously published guidelines from the American Academy of Pediatrics in 1995. Since the previous publication, there have been great strides made in the science and ethics of studying drugs in children. There have also been numerous legislative and regulatory advancements that have promoted the study of drugs in children while simultaneously allowing for the protection of this particularly vulnerable group. This report summarizes these changes and advances and provides a framework from which to guide and monitor the ethical conduct of studies to evaluate drugs in children.

  5. [Key Points for Design and Evaluation of Clinical Studies in Treating Children's Attention Deficit Hyperactivity Disorder by Chinese Medical New Drugs].

    PubMed

    Shen, Wen; Ma, Rong; Hu, Si-yuan

    2015-05-01

    Based on collecting data at home and abroad, we combined clinical practice of scientific researches. We also summarized key points for design and evaluation of clinical studies in treating children's attention deficit hyperactivity disorder by Chinese medical new drugs from objective and design, selection of diagnostic criteria, recruitment and dropping-out of subjects, effectiveness evaluation, safety evaluation, drug combination, and quality control, and so on. We hope to provide reference for design and evaluation of clinical studies by Chinese medical new drugs.

  6. Prospective and randomized study to evaluate the clinical impact of cap assisted colonoscopy (CAC).

    PubMed

    Frieling, T; Neuhaus, F; Kuhlbusch-Zicklam, R; Heise, J; Kreysel, C; Hülsdonk, A; Blank, M; Czypull, M

    2013-12-01

    Although colonoscopy is the standard procedure in the diagnosis of colorectal neoplasia, a significant number of clinical relevant lesions may be missed even by experienced endoscopists using current technology. A transparent cap mounted at the tip of a colonoscope may be an easy way to extend the visual field during colonoscopy and may improve the detection rate of mucosal lesions. The significance of cap assisted (CAC) vs. conventional colonoscopy (CC) on polyp detection rate was evaluated in a prospective randomized controlled trial in 504 patients. CC and CAC detected polyps in 39.3 % and 31.8, not significantly different. There was also no significant difference between CAC and CC according to age, sex, indication for colonoscopy, diverticulosis, sedation, bowel cleansing, withdrawal time, time/number of attempts to intubate the cecal walve, number, localization, size or histology of polyps,. However, the time to reach the cecal floor and the overall time of colonoscopy were significantly lower for CAC (1 minute). CAC was without clinical impact on polyp detection rate or performance of colonoscopy. © Georg Thieme Verlag KG Stuttgart · New York.

  7. Observational studies often make clinical practice recommendations: an empirical evaluation of authors' attitudes.

    PubMed

    Prasad, Vinay; Jorgenson, Joel; Ioannidis, John P A; Cifu, Adam

    2013-04-01

    Although observational studies provide useful descriptive and correlative information, their role in the evaluation of medical interventions remains contentious. There has been no systematic evaluation of authors' attitudes toward their own nonrandomized studies and how often they recommend specific medical practices. We reviewed all original articles of nonrandomized studies published in 2010 in New England Journal of Medicine, Lancet, Journal of the American Medical Association, and Annals of Internal Medicine. We classified articles based on whether authors recommend a medical practice and whether they state that a randomized trial is needed to support their recommendation. We also examined the types of logical extrapolations used by authors who did advance recommendations. Of the 631 original articles published in 2010, 298 (47%) articles were eligible observational studies. In 167 (56%) of 298 studies, authors recommended a medical practice based on their results. Only 24 (14%) of 167 studies stated that a randomized controlled trial (RCT) should be done to validate the recommendation, whereas the other 143 articles made a total of 149 logical extrapolations to recommend specific medical practices. Recommendations without a call for a randomized trial were most common in studies of modifiable factors (59%), but they were also common in studies reporting incidence or prevalence (51%), studies examining novel tests (41%), and association studies of nonmodifiable factors (32%). The authors of observational studies often extrapolate their results to make recommendations concerning a medical practice, typically without first calling for a RCT. Published by Elsevier Inc.

  8. Uncorrected amteropia among children hospitalized for headache evaluation: a clinical descriptive study.

    PubMed

    Dotan, Gad; Stolovitch, Chaim; Moisseiev, Elad; Cohen, Shlomi; Kesler, Anat

    2014-09-29

    Headache is a common complaint in children occasionally requiring hospital admission. The purposes of the present study were to analyze the prevalence of uncorrected ametropia in children with headache admitted to the hospital, and evaluate the importance of refraction assessment as part of their evaluation. A retrospective review of children admitted to the Tel Aviv Medical Center for headache evaluation from December 2008 to March 2013, in whom the only abnormality found was an uncorrected refractive error. During the study period 917 children with headache were hospitalized for evaluation and 16 (1.7%) of them (9 boys, mean age 12 years, range 8-18 years) were found to have an uncorrected ametropia. Average headache duration was 4 months (range, 1 week to 1 year) and mean follow-up was 15 months (range, 1 month to 3 years). Twelve (75%) children had brain imaging and 4 children (25%) had a lumbar puncture before their refractive abnormality was identified. Anisometropia and myopia were the most common refractive errors encountered (n = 10 each), followed by hyperopia (n = 6) and astigmatism (n = 3). Despite having uncorrected refractive errors most children (n = 10) did not complain of any visual difficulty. All children were given proper refractive correction and 14 of them reported complete headache resolution on re-examination one month later. Uncorrected ametropia is a possible cause of headache among hospitalized children. Therefore, complete ophthalmic evaluation, which includes proper refraction assessment, is important as it can identify a treatable headache etiology. Children without visual difficulty should be equally evaluated, as many children with headache and uncorrected amteropia do not have vision complaints.

  9. Clinical evaluation of the centrifugal pump in open heart surgery: a comparative study of different pumps.

    PubMed

    Takarabe, K; Yoshikai, M; Murayama, J; Hamada, M; Ito, T

    1997-07-01

    The centrifugal pump is now widely used in open heart surgery for its clinical benefits related to the blood elements and the coagulation system. The purpose of this study was to compare the clinical performances of and the outcomes offered by 4 types of centrifugal pumps. For each pump, we investigated the effects on the blood elements, coagulation system, complements, and immunoglobulins during open heart surgery. Four types of centrifugal pumps were used: the HPM-15 (Nikkiso Co.), the Capiox (Terumo Co.), the Lifestream (St. Jude Medical Co.), and the BP-80 (Medtronic, BioMedicus Co.). The platelet count, lactate dehydrogenase (LDH), antithrombin III (AT III), thrombin-antithrombin complex (TAT), complements (C3, C4, and CH50), and immunoglobulins (IgG, IgA, and IgM) were measured before and after cardiopulmonary bypass (CPB). The platelet count was decreased more significantly by the HPM-15 than by any of the other pumps. The other parameters showed no difference among the 4 pumps. In clinical use, each of the 4 types of centrifugal pumps was safe.

  10. Actigraphy in human African trypanosomiasis as a tool for objective clinical evaluation and monitoring: a pilot study.

    PubMed

    Njamnshi, Alfred K; Seke Etet, Paul F; Perrig, Stephen; Acho, Alphonse; Funsah, Julius Y; Mumba, Dieudonné; Muyembe, Jean-Jacques; Kristensson, Krister; Bentivoglio, Marina

    2012-01-01

    Human African trypanosomiasis (HAT) or sleeping sickness leads to a complex neuropsychiatric syndrome with characteristic sleep alterations. Current division into a first, hemolymphatic stage and second, meningoencephalitic stage is primarily based on the detection of white blood cells and/or trypanosomes in the cerebrospinal fluid. The validity of this criterion is, however, debated, and novel laboratory biomarkers are under study. Objective clinical HAT evaluation and monitoring is therefore needed. Polysomnography has effectively documented sleep-wake disturbances during HAT, but could be difficult to apply as routine technology in field work. The non-invasive, cost-effective technique of actigraphy has been widely validated as a tool for the ambulatory evaluation of sleep disturbances. In this pilot study, actigraphy was applied to the clinical assessment of HAT patients. Actigraphy was recorded in patients infected by Trypanosoma brucei gambiense, and age- and sex-matched control subjects. Simultaneous nocturnal polysomnography was also performed in the patients. Nine patients, including one child, were analyzed at admission and two of them also during specific treatment. Parameters, analyzed with user-friendly software, included sleep time evaluated from rest-activity signals, rest-activity rhythm waveform and characteristics. The findings showed sleep-wake alterations of various degrees of severity, which in some patients did not parallel white blood cell counts in the cerebrospinal fluid. Actigraphic recording also showed improvement of the analyzed parameters after treatment initiation. Nocturnal polysomnography showed alterations of sleep time closely corresponding to those derived from actigraphy. The data indicate that actigraphy can be an interesting tool for HAT evaluation, providing valuable clinical information through simple technology, well suited also for long-term follow-up. Actigraphy could therefore objectively contribute to the clinical

  11. Longitudinal clinical evaluation of fiber-reinforced composite fixed partial dentures: a pilot study.

    PubMed

    Altieri, J V; Burstone, C J; Goldberg, A J; Patel, A P

    1994-01-01

    This report describes a clinical pilot study that monitored a group of 12 patients who have received 14 single tooth replacement experimental restorations made with prefabricated continuous fiber-reinforced composite (FRC) frameworks. Because these restorations represent a purely adhesive restorative system, tooth preparation was not performed. The Kaplan-Meier survival probability at 12 months was approximately 50%. The restoration with the longest service life was a mandibular molar replacement that has remained in service 24 months. With improved survival times, bonded FRC definitive restorations should be plausible.

  12. Evaluating the Reliability of EHR-Generated Clinical Outcomes Reports: A Case Study.

    PubMed

    Kanger, Chatrian; Brown, Lisanne; Mukherjee, Snigdha; Xin, Haichang; Diana, Mark L; Khurshid, Anjum

    2014-01-01

    Quality incentive programs, such as Meaningful Use, operate under the assumption that clinical quality measures can be reliably extracted from EHRs. Safety Net providers, particularly Federally Qualified Health Centers and Look-Alikes, tend to be high adopters of EHRs; however, recent reports have shown that only about 9% of FQHCs and Look-Alikes were demonstrating meaningful use as of 2013. Our experience working with the Crescent City Beacon Community (CCBC) found that many health centers relied on chart audits to report quality measures as opposed to electronically generating reports directly from their EHRs due to distrust in the data. This paper describes a step-by-step process for improving the reliability of data extracted from EHRs to increase reliability of quality measure reports, to support quality improvement, and to achieve alignment with national clinical quality reporting requirements. Lack of standardization in data capture and reporting within EHRs drives distrust in EHR-reported data. Practices or communities attempting to achieve standardization may look to CCBC's experience for guidance on where to start and the level of resources required in order to execute a data standardization project. During the time of this data standardization project, CCBC was launching an HIE. Lack of trust in EHR data was a driver for distrust in the HIE data. We present a case study where a five-step process was used to harmonize measures, reduce data errors, and increase trust in EHR clinical outcomes reports among a community of Safety Net providers using a common EHR. Primary outcomes were the incidence of reporting errors and the potential effect of error types on quality measure percentages. The activities and level of resources required to achieve these results were also documented by the CCBC program. Implementation of a community-wide data reporting project resulted in measure harmonization, reduced reporting burden, and error reduction in EHR

  13. Evaluating the Reliability of EHR-Generated Clinical Outcomes Reports: A Case Study

    PubMed Central

    Kanger, Chatrian; Brown, Lisanne; Mukherjee, Snigdha; Xin, Haichang; Diana, Mark L.; Khurshid, Anjum

    2014-01-01

    Introduction: Quality incentive programs, such as Meaningful Use, operate under the assumption that clinical quality measures can be reliably extracted from EHRs. Safety Net providers, particularly Federally Qualified Health Centers and Look-Alikes, tend to be high adopters of EHRs; however, recent reports have shown that only about 9% of FQHCs and Look-Alikes were demonstrating meaningful use as of 2013. Our experience working with the Crescent City Beacon Community (CCBC) found that many health centers relied on chart audits to report quality measures as opposed to electronically generating reports directly from their EHRs due to distrust in the data. This paper describes a step-by-step process for improving the reliability of data extracted from EHRs to increase reliability of quality measure reports, to support quality improvement, and to achieve alignment with national clinical quality reporting requirements. Background: Lack of standardization in data capture and reporting within EHRs drives distrust in EHR-reported data. Practices or communities attempting to achieve standardization may look to CCBC’s experience for guidance on where to start and the level of resources required in order to execute a data standardization project. During the time of this data standardization project, CCBC was launching an HIE. Lack of trust in EHR data was a driver for distrust in the HIE data. Methods: We present a case study where a five-step process was used to harmonize measures, reduce data errors, and increase trust in EHR clinical outcomes reports among a community of Safety Net providers using a common EHR. Primary outcomes were the incidence of reporting errors and the potential effect of error types on quality measure percentages. The activities and level of resources required to achieve these results were also documented by the CCBC program. Findings: Implementation of a community-wide data reporting project resulted in measure harmonization, reduced reporting

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

    PubMed

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

    2015-03-01

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

  15. Factors influencing change in clinical practice: A qualitative evaluation of the implementation of the quality improvement in colonoscopy study.

    PubMed

    Rajasekhar, Praveen T; Rees, Colin J; Nixon, Catherine; East, James E; Brown, Sally

    2016-01-01

    The quality improvement in colonoscopy study was a region wide service improvement study to improve adenoma detection rate at colonoscopy by implementing evidence into routine colonoscopy practice. Implementing evidence into clinical practice can be challenging. The purpose of this paper is to perform a qualitative interview study to evaluate factors that influenced implementation within the study. Semi-structured interviews were conducted with staff in endoscopy units taking part in the quality improvement in colonoscopy study, after study completion. Units and interviewees were purposefully sampled to ensure a range of experiences was represented. Interviews were conducted with 11 participants. Key themes influencing uptake of the quality improvement in colonoscopy evidence bundle included time, study promotion, training, engagement, positive outcomes and modifications. Areas within themes were increased awareness of quality in colonoscopy (QIC), emphasis on withdrawal time and empowerment of endoscopy nurses to encourage the use of quality measures were positive outcomes of the study. The simple, visible study posters were reported as useful in aiding study promotion. Feedback sessions improved engagement. Challenges included difficulty arranging set-up meetings and engaging certain speciality groups. This evaluation suggests that methods to implement evidence into clinical practice should include identification and empowerment of team members who can positively influence engagement, simple, visible reminders and feedback. Emphasis on timing of meetings and strategies to engage speciality groups should also be given consideration. Qualitative evaluations can provide important insights into why quality improvement initiatives are successful or not, across different sites.

  16. Evaluation of Palatal Plate Thickness of Maxillary Prosthesis on Phonation- A Comparative Clinical Study

    PubMed Central

    B, Sreedevi; Anne, Gopinadh; Manne, Prakash; Bindu O, Swetha Hima; Atla, Jyothi; Deepthi, Sneha; Chaitanya A, Krishna

    2014-01-01

    Background: Prosthodontic treatment involves clinical procedures which influence speech performance directly or indirectly. Prosthetic rehabilitation of missing teeth with partial or complete maxillary removable dentures influences the individual voice characteristics like Phonation, resonance etc. Aim: To evaluate the effect of Acrylic palatal plate thickness (1mm-3mm) of maxillary prosthesis on phonation. Materials and Methods: Twelve subjects were selected randomly between the age group of 20-25 years who have full complement of teeth and have no speech problems. Speech evaluation was done under four experimental conditions i.e. Without any experimental acrylic palatal plate (control), with experimental acrylic palatal plates of thickness 1 mm, 2 mm and 3 mm respectively. The speech material for phonation test consisted of Vowels sounds /a/, /i/, and /o/. Speech analysis to assess phonation was done using digital acoustic analysis (PRAAT software). The obtained results were statistically analyzed by One-way ANOVA and Tukey’s multiple post-hoc for comparison of four experimental conditions with respect to different vowel sounds. Results: Mean harmonics to noise ratio (HNR) values obtained for all the Experimental conditions did not show significant difference (p>0.05). In conclusion, an increase in the thickness of the acrylic palatal plate of maxillary prosthesis for about 1 mm - 3mm in complete or partial maxillary removable dentures resulted in no significant effect on phonation of vowel sounds /a/, /i/ and /o/. Conclusion: Increasing the thickness of the palatal plate from 1 mm to 3 mm has not shown any significant effect on the phonation. PMID:24959508

  17. The virtual clinical evaluation tool.

    PubMed

    Sander, Rebecca; Trible, Karen A

    2008-01-01

    Two years ago, faculty and students at this rural university setting collaborated to implement a virtual clinical evaluation tool. In recognition of the frustrations involved in coordinating instructor and student input to a hard copy tool, a virtual clinical evaluation tool was created in the form of an Excel spreadsheet. Excel documents have the advantage of immediate retrieval and use by instructors or students, ease of narration by word processing, automatic mathematical computation of formative and summative scores, and data storage through computer archives. Using the online Blackboard course, students and instructors are able to collaboratively input a Likert score for each posted evaluation outcome and word process-related comments about students' clinical performance. An overview of the 2-year implementation of this virtual clinical evaluation tool, as well as the evaluation process, is discussed.

  18. Clinical evaluation of moxalactam.

    PubMed Central

    Mathisen, G E; Meyer, R D; Thompson, J M; Finegold, S M

    1982-01-01

    Moxalactam was administered intravenously or intramuscularly or both in doses of 1 to 12 g/day to 45 patients with clinically significant infections (17 soft tissue or bone, 9 pleuropulmonary, 9 septicemic, 6 urinary tract, and 4 intraabdominal infections). Mean 0.5-h postinfusion levels were 105 micrograms/ml for a 4.0-g dose, 44.7 micrograms/ml for a 2.0-g dose, and 18 micrograms/ml for a 1.0-g dose. We identified 28 isolates of Enterobacteriaceae, 10 Pseudomonas aeruginosa isolates, 9 Staphylococcus aureus isolates, and 15 anaerobic bacterial isolates. A total of 15 patients were clinically cured, 8 patients improved, 13 patients improved initially but suffered subsequent relapses or superinfections, and 10 patients failed therapy. Toxicity was generally minimal (reversible eosinophilia, and mild liver function abnormalities, and elevated prothrombin time). The selection or emergence of resistant organisms in 17 patients during treatment (particularly Pseudomonas, enterococci, and Candida) was a disturbing feature of therapy. Our results were generally favorable, considering the complicated underlying medical problems of this group of patients. PMID:6213198

  19. A clinical evaluation of flurbiprofen LAT and piroxicam gel: a multicentre study in general practice.

    PubMed

    Ritchie, L D

    1996-05-01

    A prospective, randomized, multicentre, open, crossover study of the comparative efficacy, tolerability and acceptability of two topical nonsteroidal anti-inflammatory drug (NSAID) therapies, flurbiprofen local-action transcutaneous (LAT) patch (40 mg b.d.) and piroxicam gel (3 cm, 0.5% q.d.s), was conducted in general practice in the UK in 137 men and women with soft-tissue rheumatism of the shoulder or elbow (e.g. epicondylitis, tendinitis, bursitis and adhesive capsulitis). Patients received one therapy for 4 days before crossing over to the other NSAID for a further 4 days, followed by 6 days of their preferred therapy. Clinical assessment of severity of pain, tenderness and overall clinical condition was carried out at baseline and after 4, 8 and 14 days. Patients self-assessed the severity of pain during the day and at night, and also the quality of their sleep during each treatment phase. More patients showed a greater improvement in all of the clinical assessments of efficacy following treatment with flurbiprofen LAT during the crossover phase. There was a statistically significant reduction in the severity of pain, the principal measure of efficacy, in favour of flurbiprofen LAT: 42% of patients showed greater improvement with flurbiprofen LAT compared with 26% who showed a greater improvement with piroxicam gel (p = 0.012; n = 131, intent-to-treat). Eligible dataset (n = 126) analysis revealed statistically significant differences in favour of flurbiprofen LAT in the severity of lesion tenderness (p = 0.03) and the overall change in clinical condition (p = 0.04) compared with baseline status. Superior efficacy for flurbiprofen LAT was also indicated in the patients' assessment at the end of the crossover phase (day 8), at which 69% chose to continue treatment with flurbiprofen LAT compared with only 31% of patients who chose piroxicam gel (n = 126; p < 0.001). There were, in addition, statistically significant differences in favour of flurbiprofen LAT in

  20. Emergence of cowpox: study of the virulence of clinical strains and evaluation of antivirals.

    PubMed

    Duraffour, Sophie; Mertens, Barbara; Meyer, Hermann; van den Oord, Joost J; Mitera, Tania; Matthys, Patrick; Snoeck, Robert; Andrei, Graciela

    2013-01-01

    The last years, cowpox infections are being increasingly reported through Eurasia. Cowpox viruses (CPXVs) have been reported to have different genotypes and may be subdivided in at least five genetically distinct monophyletic clusters. However, little is known about their in vitro and in vivo features. In this report, five genetically diverse CPXVs, including one reference strain (CPXV strain Brighton) and four clinical isolates from human and animal cases, were compared with regard to growth in cells, pathogenicity in mice and inhibition by antivirals. While all CPXVs replicated similarly in vitro and showed comparable antiviral susceptibility, marked discrepancies were seen in vivo, including differences in virulence with recorded mortality rates of 0%, 20% and 100%. The four CPXV clinical isolates appeared less pathogenic than two reference strains, CPXV Brighton and vaccinia virus Western-Reserve. Disease severity seemed to correlate with high viral DNA loads in several organs, virus titers in lung tissues and levels of IL-6 cytokine in the sera. Our study highlighted that the species CPXV consists of viruses that not only differ considerably in their genotypes but also in their in vivo phenotypes, indicating that CPXVs should not be longer classified as a single species. Lung virus titers and IL-6 cytokine level in mice may be used as biomarkers for predicting disease severity. We further demonstrated the potential benefit of cidofovir, CMX001 and ST-246 use as antiviral therapy.

  1. Emergence of Cowpox: Study of the Virulence of Clinical Strains and Evaluation of Antivirals

    PubMed Central

    Duraffour, Sophie; Mertens, Barbara; Meyer, Hermann; van den Oord, Joost J.; Mitera, Tania; Matthys, Patrick; Snoeck, Robert; Andrei, Graciela

    2013-01-01

    The last years, cowpox infections are being increasingly reported through Eurasia. Cowpox viruses (CPXVs) have been reported to have different genotypes and may be subdivided in at least five genetically distinct monophyletic clusters. However, little is known about their in vitro and in vivo features. In this report, five genetically diverse CPXVs, including one reference strain (CPXV strain Brighton) and four clinical isolates from human and animal cases, were compared with regard to growth in cells, pathogenicity in mice and inhibition by antivirals. While all CPXVs replicated similarly in vitro and showed comparable antiviral susceptibility, marked discrepancies were seen in vivo, including differences in virulence with recorded mortality rates of 0%, 20% and 100%. The four CPXV clinical isolates appeared less pathogenic than two reference strains, CPXV Brighton and vaccinia virus Western-Reserve. Disease severity seemed to correlate with high viral DNA loads in several organs, virus titers in lung tissues and levels of IL-6 cytokine in the sera. Our study highlighted that the species CPXV consists of viruses that not only differ considerably in their genotypes but also in their in vivo phenotypes, indicating that CPXVs should not be longer classified as a single species. Lung virus titers and IL-6 cytokine level in mice may be used as biomarkers for predicting disease severity. We further demonstrated the potential benefit of cidofovir, CMX001 and ST-246 use as antiviral therapy. PMID:23457480

  2. Clinical evaluation of stereopsis.

    PubMed

    Westheimer, Gerald

    2013-09-20

    Principles of the design and administration of clinical stereopsis tests are outlined. Once the presence of the distinct sense of the third dimension by binocular vision alone and without help from monocular cues has been established in a patient, the examination can proceed to the measurement of stereoscopic acuity. Best results are obtained with high-contrast, sharp, well-articulated and uncrowded elements from easily-recognized target sets, displayed with no time constraints. Polarization is the preferred method of right/left eye separation; time-sharing at a minimum of 60 Hz on computer displays with counterphase occluding goggles is a feasible procedure. Random-dot stereograms are problematic because not all observers can disentangle the coherent global disparity on a first view. Copyright © 2012 Elsevier Ltd. All rights reserved.

  3. Comparative evaluation of ankaferd blood stopper, ferric sulfate, and formocresol as pulpotomy agent in primary teeth: A clinical study.

    PubMed

    Ozmen, B; Bayrak, S

    2017-07-01

    The aim of the study was to provide a comparative evaluation of the clinical and radiographic success of Ankaferd blood stopper (ABS), formocresol (FC), and ferric sulfate (FS) as pulpotomy agent in primary teeth. This is a clinical study. A total of 45 primary mandibular molar teeth in 26 children aged 6-9 were selected for the study. Teeth were randomly divided into three groups according to the pulpotomy agents (ABS, FC, FS). Following treatment, for 24 months, teeth were clinically and radiographically evaluated once every 3 and 6 months respectively. SPSS version 15 software was used in data analysis. Kaplan- Meier, Log Rank and Fisher's exact tests were used to analysis. After follow-up periods ranging from 6 to 24 months (average 20.8±0.56), the clinical success rates for ABS, FC, and FS were 87%, 87%, and 100% respectively. The overall radiographic success was 87%, 80%, and 87%. When success rates of the ABS were compared with other agents, there were no significant differences between groups (P > 0.05). Similar success was achieved in the pulpotomy treatment of primary teeth that using ABS, FC, and FS. ABS would be considered a suitable agent for pulpotomy treatment and can be used as an alternative to other agents.

  4. [Physician knowledge and attitudes on the clinical evaluation and treatment of resistant hypertension: The RESIST study].

    PubMed

    Coca, A

    Resistant hypertension (RH) is associated with a high risk of cardiovascular and renal complications. The purpose of this study was to assess the knowledge and attitudes of Primary Care physicians, general medicine doctors, and clinical cardiologists on the management of this condition. A multicentre, descriptive, observational study based on an ad hoc questionnaire distributed to Primary Care physicians (n=1017) and general medicine physicians/clinical cardiologists (n=457). To establish the diagnosis of resistant hypertension, 69.1% of physicians confirm that systolic/diastolic blood pressure is above 140/90 mmHg, despite treatment. Furthermore, 64.9% only consider this diagnosis if the patient is treated with at least 3 medications, and 50.3% also requires that one of them is a thiazide diuretic (56.7% among specialists, P=.0004). To establish a definite diagnosis of true RH, 89.6% perform 24-h ambulatory blood pressure monitoring (93.3% of specialists, P=.0017), looking specifically for «white-coat» effect in 70.2% of cases. In addition, 79.3% verify that adherence to treatment is adequate. Between 87 and 95% of physicians indicate examinations to exclude causes of secondary hypertension. Up to 54.3% of physicians (71.3% specialists, P<.0001) consider adding a fourth drug and insisting on lifestyle interventions as a priority therapeutic measure. These data show that physician knowledge regarding the management of patients with RH is good. Interestingly, this knowledge is somewhat higher among specialists than among Primary Care physicians. Copyright © 2016 SEH-LELHA. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. Evaluation of an artificial intelligence guided inverse planning system: clinical case study.

    PubMed

    Yan, Hui; Yin, Fang-Fang; Willett, Christopher

    2007-04-01

    An artificial intelligence (AI) guided method for parameter adjustment of inverse planning was implemented on a commercial inverse treatment planning system. For evaluation purpose, four typical clinical cases were tested and the results from both plans achieved by automated and manual methods were compared. The procedure of parameter adjustment mainly consists of three major loops. Each loop is in charge of modifying parameters of one category, which is carried out by a specially customized fuzzy inference system. A physician prescribed multiple constraints for a selected volume were adopted to account for the tradeoff between prescription dose to the PTV and dose-volume constraints for critical organs. The searching process for an optimal parameter combination began with the first constraint, and proceeds to the next until a plan with acceptable dose was achieved. The initial setup of the plan parameters was the same for each case and was adjusted independently by both manual and automated methods. After the parameters of one category were updated, the intensity maps of all fields were re-optimized and the plan dose was subsequently re-calculated. When final plan arrived, the dose statistics were calculated from both plans and compared. For planned target volume (PTV), the dose for 95% volume is up to 10% higher in plans using the automated method than those using the manual method. For critical organs, an average decrease of the plan dose was achieved. However, the automated method cannot improve the plan dose for some critical organs due to limitations of the inference rules currently employed. For normal tissue, there was no significant difference between plan doses achieved by either automated or manual method. With the application of AI-guided method, the basic parameter adjustment task can be accomplished automatically and a comparable plan dose was achieved in comparison with that achieved by the manual method. Future improvements to incorporate case

  6. Identification of relevant ICF categories in vocational rehabilitation: a cross sectional study evaluating the clinical perspective.

    PubMed

    Finger, Monika E; Glässel, Andrea; Erhart, Peter; Gradinger, Felix; Klipstein, Andreas; Rivier, Gilles; Schröer, Maria; Wenk, Christian; Gmünder, Hans Peter; Stucki, Gerold; Escorpizo, Reuben

    2011-06-01

    Vocational rehabilitation (VR) emphasizes a need for medical support, rehabilitation and biopsychosocial approach to enable individuals to successfully participate in the workforce. Optimal rehabilitation management relies on an in-depth knowledge of the typical spectrum of problems encountered of patients in VR. The International Classification of Functioning, Disability and Health (ICF) is based on a universal conceptual model and provides a holistic view of functioning of the lived experience of people such as those undergoing VR. The objectives of this study are to describe the functioning and health of persons undergoing VR and to identify the most common problems around work and in VR using the ICF as the reference framework. An empirical cross-sectional multicenter study was conducted using convenience sampling from March 2009 to March 2010. Data were collected using a Case Record Form rated by health professionals which was based on an extended version of the ICF Checklist containing 292 ICF categories and sociodemographic information. 152 patients with various health conditions participated. We identified categories from all four ICF components: 24 for body functions, six for body structures, 45 for activities and participation, and 25 for environmental factors. Our study identified a multitude of ICF categories that describe functioning domains and which represent the complexity of VR. Such a comprehensive approach in assessing patients in VR may help to understand and customize the process of VR in the clinical setting and to enhance multidisciplinary communication.

  7. Clinical study to evaluate the effect of Virechanakarma on serum electrolytes

    PubMed Central

    Rais, Adil; Bhatted, Santoshkumar

    2013-01-01

    Panchakarma therapy aims at the elimination of excessive Doshas from the body to maintain the state of health for a longer duration, while the Shamana therapy is for suppression of vitiated Doshas within the body. Virechana is one of the Panchakarma therapies wherein purgation is induced by drugs and it specifically aims at the elimination of excessive Pitta Dosha from the body. Normally, after Virechanakarma, patient does not complain of having any untoward like those present after diarrhea due to dehydration. This study was conducted to evaluate the effect of Virechanakarma on serum electrolyte levels and to ascertain the safety of therapeutic purgation. This study involved estimation of serum electrolyte levels before and after Virechana in 15 patients and the results are suggestive of safe application of the Virechana therapy as the deviation in electrolyte levels were within the normal range. PMID:24696575

  8. USE OF THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE (MCID) FOR EVALUATING TREATMENT OUTCOMES WITH TMJMD PATIENTS: A PRELIMINARY STUDY1

    PubMed Central

    Ingram, Megan; Choi, Yun Hee; Chiu, Chung-Yi; Haggard, Rob; Dougall, Angela Liegey; Buschang, Peter; Gatchel, Robert J.

    2012-01-01

    Temporomandibular joint and muscle disorder (TMJMD) is one of the most prevalent types of musculoskeletal disorders. The major goal of the study was to more objectively quantify clinically meaningful relief for TMJMD treatment outcomes by using the new metric of minimal clinically important difference (MCID). Pre- to post-treatment changes on a number of self-report measures were evaluated in a cohort of 101 acute TMJMD patients. An anchor-based MCID approach was employed, with an objective chewing performance measure serving as the clinical outcome of interest. Using a Receiver Operating Curve analysis, it was found that the Physical Component Scale (PCS) of the SF-36 was the most robust self-report measure to use as the MCID in a TMJMD patient population. PMID:22919263

  9. Biograft-HT® as a bone graft material in the treatment of periodontal vertical defects and its clinical and radiological evaluation: Clinical study

    PubMed Central

    Chandrashekar, K. T.; Saxena, Chhavi

    2009-01-01

    Aim: To determine the efficacy of Biograft-HT® as a bone graft material in the treatment of vertical defects in generalized chronic periodontitis patients and their clinical and radiological evaluation. Patients and Methods: Twenty patients diagnosed with generalized chronic periodontitis having two or more vertical defects were selected for this study. Clinical parameters like plaque index, gingival index, probing pocket depth and clinical attachment levels were recorded at different points of time over six months. Radiographic evaluation included the depth of the bone defect and the percentage of bone defect fill and was carried out for both the groups at baseline, three months and six months. After recording clinical parameters and administering phase-1 therapy, the sites were randomly treated either with Biograft- HT® or open flap debridement only. Results: At the end of six months there was a significant reduction in the plaque and gingival scores in both test and control groups. There was 64% decrease in probing pocket depth for the test site as compared to 54.52% decrease seen for the control group. Similarly there was an 84.82% gain in clinical attachment level from the baseline to six months post operatively for the experimental group in comparison to 68.83% gain for the control group. Furthermore, 43.57% bone fill was observed for the experimental site whereas only 17.98% of bone fill was evident in the control site. Conclusion: Biograft –HT improves healing outcomes, leads to a reduction of probing depth, a resolution of osseous defects and a gain in clinical attachment, compared with open flap debridement by itself. PMID:20379411

  10. Gow-Gates Technique: A Pilot Study for Extraction Procedures With Clinical Evaluation and Review

    PubMed Central

    Kohler, Bernhard Rolf; Castellón, Loreto; Laissle, Germán

    2008-01-01

    The aim of this study was to compare the effectiveness of 2 different volumes of anesthetic solution for a premolar-molar extraction, and to determine the onset of complete mandibular conduction anesthesia via a Gow-Gates mandibular block. One operator performed 32 blocks with a 27-gauge needle on patients who required a dental extraction: 16 blocks using 1.8 mL of anesthetic solution, and 16 blocks using 3.6 mL of anesthetic solution. The parameters evaluated were frequency of successful anesthesia and onset of complete anesthesia. Significant differences (P < .005) were observed in the evaluation of volume: the 3.6 mL group yielded a higher success rate (82.5%) than the 1.8 mL group (17.5%). The onset of complete conduction anesthesia was achieved in 8 minutes by 56% of the subjects (9 of 16) with 3.6 mL and only one subject in 16 (6%) with 1.8 mL. A larger volume of anesthetic solution (3.6 mL) is required to achieve a higher success rate and a faster onset of action for a dental extraction without the use of reinforcement anesthesia. The volume of anesthetic solution is indirectly proportional to the onset of complete anesthesia. A premolar-molar extraction can be done, with 3.6 mL of anesthetic solution, in more than 50% of the patients 8 minutes after injection. PMID:18327969

  11. The evaluation of chorionic membrane in guided tissue regeneration for periodontal pocket therapy: a clinical and radiographic study.

    PubMed

    Kothiwale, Shaila V

    2014-03-01

    Periodontal regenerative therapy is aimed at reconstruction and to restore the architecture and function of lost or injured tissues. Melcher (J Periodontol 47(5):256-260, 1976) introduced the concept of guided tissue regeneration (GTR) for osseous reconstructive surgery. The aim of the present innovative clinical and radiographic study was to evaluate the effect of chorionic membrane (CM) in GTR in periodontal pocket therapy. Ten patients with moderate to severe periodontitis were selected in the single blind randomized controlled clinical trial. Patients were treated with periodontal pocket therapy along with CM in study sites and the control sites were treated with periodontal pocket therapy alone. The clinical parameters were recorded at baseline and 12 months. The radiographic parameters were recorded at baseline, 6 and 12 months. Clinical parameters included gingival index (GI), plaque index (PI), pocket probing depth (PPD) and relative attachment level (RAL). Digital images were analysed for bone gain (BG) and density. Data were evaluated using t test. Statistical significant differences were found in both sites at 12 months for GI, PI, PPD and RAL. Highly significant reduction was seen in GI 0.40 ± 0.08 (p = 0.0001), PI (0.41 ± 0.18), PPD 2.50 ± 0.53 mm (p = 0.0431) and increased BG 0.86 ± 0.18 (p < 0.0001) were observed in study sites. This shows that CM when used with pocket therapy can have influence on clinical parameters. Radiographic findings from this study demonstrated significant BG and density in sites treated with CM as compared to control sites.

  12. Evaluation of Hanau's formula in determination of lateral condylar guidance: A clinical research study

    PubMed Central

    Bhawsar, Sanjay Vasant; Marathe, Ashlesha Subhash; Ansari, Sadekh Abdul

    2015-01-01

    Statement of Problem: The accuracy and reliability of the methods used for programming the semi-adjustable articulators determine the accuracy in occlusion. The current recommended average settings using the Hanau's formula commonly used by clinicians is questionable, and thus reassessment is needed. This study was carried out to evaluate and compare the lateral condylar guidance: (1) Using the Hanau's formula and the computerized jaw tracking device (Kinesiograph). (2) On the right and left sides using both these methods. Materials and Methods: A total of 20 completely edentulous patients (14 male and 6 females) within 40–60 years of age were selected. Jaw relation was recorded followed by face bow transfer. Extraoral Gothic arch tracing was recorded; three protrusive records were obtained and condylar guidance was calculated. Lateral condylar guidance was then calculated using Hanau's formula, followed by the computerized jaw tracking device. A comparative evaluation was done of the obtained values. The same investigator worked with each of the study participants for the purpose of standardization. Results: The lateral condylar guidance values obtained using the Hanau's formula ranged from 14 to 17° while those obtained using the computerized K7 jaw tracking device ranged from 8 to 40°. Bennett angle values, obtained using the jaw tracking device and Hanau's formula showed statistically significant differences (P < 0.05) using paired t-test (at 95% confidence interval). Bennett angle values of the right and left sides found using the Hanau's formula were almost similar. Difference in the Bennett angle values of the right and left sides were found using the jaw tracking device. However, this difference was not statistically significant (P > 0.05). Conclusion: Based on the results, dentist and dental technicians should consider reassessing the current recommended average settings and use of the Hanau's formula for programming the semi-adjustable articulators

  13. Comparative photographic evaluation of various geometric and mathematical proportions of maxillary anterior teeth: A clinical study.

    PubMed

    Agrawal, Vineet S; Kapoor, Sonali; Bhesania, Dhvani; Shah, Chintul

    2016-01-01

    This study aimed to investigate the existence of the golden proportion, recurring esthetic dental (RED) proportion and golden percentage between the frontal view widths of the maxillary anterior natural dentition among students of Indian origin by the aid of digital photography. This study was conducted with 80 dental students (41 female and 39 male), with ages ranging from 20 to 23 years. Students whose natural smile did not develop any visual tension with regard to the study's and their own criteria were selected as having an esthetic smile. Photographs were taken, and the mesiodistal widths of six maxillary anterior teeth were measured digitally using software. Once the measurements were recorded three different theories of proportion were applied and statistical analysis was done. The golden proportion, i.e., 62% RED proportion and golden percentage were not observed in the subjects. According to the subjects evaluated, the average width of the maxillary lateral incisor was 72% of the frontal view width of the central incisor. The average width of the canine was 84% of the frontal view width of the lateral incisor. The golden proportion and RED proportion were not observed in the natural smiles of subjects who were deemed to have an esthetic smile. The values proposed for the golden percentage theory were not observed in subjects with an esthetic smile. Average frontal view percentage widths of the maxillary anterior dentition exist and can be useful in predicting naturally occurring widths in smiles deemed to be esthetic in a specific population.

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

    PubMed

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

    2016-02-01

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

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

    PubMed Central

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

    2016-01-01

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

  16. Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study

    PubMed Central

    Stans, Jelle; Van Schelvergem, Gertjan; Pelckmans, Caroline; Smeets, Christophe JP; Lanssens, Dorien; De Cannière, Hélène; Storms, Valerie; Thijs, Inge M; Vandervoort, Pieter M

    2017-01-01

    Background Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. Objective The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. Methods The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. Results In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)–peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable

  17. Clinical Validation of Heart Rate Apps: Mixed-Methods Evaluation Study.

    PubMed

    Vandenberk, Thijs; Stans, Jelle; Van Schelvergem, Gertjan; Pelckmans, Caroline; Smeets, Christophe Jp; Lanssens, Dorien; De Cannière, Hélène; Storms, Valerie; Thijs, Inge M; Vandervoort, Pieter M

    2017-08-25

    Photoplethysmography (PPG) is a proven way to measure heart rate (HR). This technology is already available in smartphones, which allows measuring HR only by using the smartphone. Given the widespread availability of smartphones, this creates a scalable way to enable mobile HR monitoring. An essential precondition is that these technologies are as reliable and accurate as the current clinical (gold) standards. At this moment, there is no consensus on a gold standard method for the validation of HR apps. This results in different validation processes that do not always reflect the veracious outcome of comparison. The aim of this paper was to investigate and describe the necessary elements in validating and comparing HR apps versus standard technology. The FibriCheck (Qompium) app was used in two separate prospective nonrandomized studies. In the first study, the HR of the FibriCheck app was consecutively compared with 2 different Food and Drug Administration (FDA)-cleared HR devices: the Nonin oximeter and the AliveCor Mobile ECG. In the second study, a next step in validation was performed by comparing the beat-to-beat intervals of the FibriCheck app to a synchronized ECG recording. In the first study, the HR (BPM, beats per minute) of 88 random subjects consecutively measured with the 3 devices showed a correlation coefficient of .834 between FibriCheck and Nonin, .88 between FibriCheck and AliveCor, and .897 between Nonin and AliveCor. A single way analysis of variance (ANOVA; P=.61 was executed to test the hypothesis that there were no significant differences between the HRs as measured by the 3 devices. In the second study, 20,298 (ms) R-R intervals (RRI)-peak-to-peak intervals (PPI) from 229 subjects were analyzed. This resulted in a positive correlation (rs=.993, root mean square deviation [RMSE]=23.04 ms, and normalized root mean square error [NRMSE]=0.012) between the PPI from FibriCheck and the RRI from the wearable ECG. There was no significant difference

  18. Clinical Evaluation of the Articulinx Intercarpometacarpal Cushion for the First CMC Joint: A Feasibility Study.

    PubMed

    van der Veen, Fiente J C; White, David N; Dapper, Mattie M L; Griot, J Peter W Don; Ritt, Marco P J F

    2013-08-01

    Background The Intercarpometacarpal Cushion (ICMC; Articulinx, Cupertino, CA, USA) is an implantable spacer designed as a less invasive surgical treatment for osteoarthritis (OA) of the first carpometacarpal joint (CMC-1). Description of Technique Following local anesthesia and exposure of the joint capsule the ICMC, attached to a needle and suture tethers, is guided into the joint space under fluoroscopic visualization through a dorsal approach. The needle is pulled through the thenar eminence to the opposite side of the hand and, once proper device placement is confirmed, cut free and the joint capsule closed. Patients and Methods Eight female patients (median age 56 years; range, 42-83) were treated and followed for 6 to 24 months. Safety of the implant procedure was evaluated intraoperatively. Pain, joint function, and strength were evaluated at 6 weeks, 3, 6, 12 and 24 months with a Visual Analog Scale (VAS) for pain, the QuickDASH inventory, Canadian Occupational Performance Measure (COPM), and pinch and grip strength measurements. Results At 2 years (n = 6), mean VAS pain scores decreased from 6.3 (± 1.5) to 2.2 (± 1.1) (p < 0.001), mean QuickDASH scores improved from 47 (± 15) to 31 (± 11) (p < 0.10), mean COPM performance scores improved from 5.0 (± 1.2) to 5.5 ( ± 1.3) (p = NS). Mean pinch and grip strength measurements also improved compared with baseline. No serious adverse events occurred. Two device removals occurred, associated with a traumatic event and Stage IV OA with device displacement, at 6 and 9 months respectively. Conclusion The ICMC can be implanted safely. Effectiveness needs to be confirmed in future studies.

  19. Regression of Moral Reasoning during Medical Education: Combined Design Study to Evaluate the Effect of Clinical Study Years

    PubMed Central

    Hren, Darko; Marušić, Matko; Marušić, Ana

    2011-01-01

    Background Moral reasoning is important for developing medical professionalism but current evidence for the relationship between education and moral reasoning does not clearly apply to medical students. We used a combined study design to test the effect of clinical teaching on moral reasoning. Methods We used the Defining Issues Test-2 as a measure of moral judgment, with 3 general moral schemas: Personal Interest, Maintaining Norms, and Postconventional Schema. The test was applied to 3 consecutive cohorts of second year students in 2002 (n = 207), 2003 (n = 192), and 2004 (n = 139), and to 707 students of all 6 study years in 2004 cross-sectional study. We also tested 298 age-matched controls without university education. Results In the cross-sectional study, there was significant main effect of the study year for Postconventional (F(5,679) = 3.67, P = 0.003) and Personal Interest scores (F(5,679) = 3.38, P = 0.005). There was no effect of the study year for Maintaining Norms scores. 3rd year medical students scored higher on Postconventional schema score than all other study years (p<0.001). There were no statistically significant differences among 3 cohorts of 2nd year medical students, demonstrating the absence of cohort or point-of-measurement effects. Longitudinal study of 3 cohorts demonstrated that students regressed from Postconventional to Maintaining Norms schema-based reasoning after entering the clinical part of the curriculum. Interpretation Our study demonstrated direct causative relationship between the regression in moral reasoning development and clinical teaching during medical curriculum. The reasons may include hierarchical organization of clinical practice, specific nature of moral dilemmas faced by medical students, and hidden medical curriculum. PMID:21479204

  20. Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology

    PubMed Central

    Ryan, Michael C.; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C.; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R.V. Paul; Chiang, Michael F.

    2014-01-01

    Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis. PMID:25954463

  1. Development and Evaluation of Reference Standards for Image-based Telemedicine Diagnosis and Clinical Research Studies in Ophthalmology.

    PubMed

    Ryan, Michael C; Ostmo, Susan; Jonas, Karyn; Berrocal, Audina; Drenser, Kimberly; Horowitz, Jason; Lee, Thomas C; Simmons, Charles; Martinez-Castellanos, Maria-Ana; Chan, R V Paul; Chiang, Michael F

    2014-01-01

    Information systems managing image-based data for telemedicine or clinical research applications require a reference standard representing the correct diagnosis. Accurate reference standards are difficult to establish because of imperfect agreement among physicians, and discrepancies between clinical vs. image-based diagnosis. This study is designed to describe the development and evaluation of reference standards for image-based diagnosis, which combine diagnostic impressions of multiple image readers with the actual clinical diagnoses. We show that agreement between image reading and clinical examinations was imperfect (689 [32%] discrepancies in 2148 image readings), as was inter-reader agreement (kappa 0.490-0.652). This was improved by establishing an image-based reference standard defined as the majority diagnosis given by three readers (13% discrepancies with image readers). It was further improved by establishing an overall reference standard that incorporated the clinical diagnosis (10% discrepancies with image readers). These principles of establishing reference standards may be applied to improve robustness of real-world systems supporting image-based diagnosis.

  2. Evaluation of the role of antibiotics in preventing postoperative complication after routine periodontal surgery: A comparative clinical study

    PubMed Central

    Mohan, Rosh Radhika; Doraswamy, Dwarakanath Chinni; Hussain, Ahad M.; Gundannavar, Gayatri; Subbaiah, Shobha Krishna; Jayaprakash, Deepika

    2014-01-01

    Background and Objectives: Aim of this randomly controlled clinical study was to evaluate the role of antibiotics to prevent postoperative complications after routine periodontal surgery and also to determine whether their administration improved the surgical outcome. Materials and Methods: Forty-five systemically healthy patients with moderate to severe chronic periodontitis requiring flap surgery were enrolled in the study. They were randomly allocated to Amoxicillin, Doxycycline, and control groups. Surgical procedures were carried out with complete asepsis as per the protocol. Postoperative assessment of patient variables like swelling, pain, temperature, infection, ulceration, necrosis, and trismus was performed at intervals of 24 h, 48 h, 1 week, and 3 months. Changes in clinical parameters such as gingival index, plaque index, probing pocket depth, and clinical attachment level were also recorded. Results: There was no incidence of postoperative infection in any of the patients. Patient variables were comparable in all the three groups. Though there was significant improvement in the periodontal parameters in all the groups, no statistically significant result was observed for any group over the others. Conclusion: Results of this study showed that when periodontal surgical procedures were performed following strict asepsis, the incidence of clinical infection was not significant among all the three groups, and also that antibiotic administration did not influence the outcome of surgery. Therefore, prophylactic antibiotics for patients who are otherwise healthy administered following routine periodontal surgery to prevent postoperative infection are unnecessary and have no demonstrable additional benefits. PMID:24872630

  3. Evaluation of patient response and recurrence of pigmentation following gingival depigmentation using laser and scalpel technique: A clinical study

    PubMed Central

    Grover, Harpreet Singh; Dadlani, Himanshu; Bhardwaj, Amit; Yadav, Anil; Lal, Sanjay

    2014-01-01

    Aim: The present study was undertaken to evaluate patient response and recurrence of pigmentation following gingival depigmentation carried out with a surgical blade and diode laser. Materials and Methods: Twenty patients who were esthetically conscious of their dark gums and requested treatment for the same were selected for this study. Complete phase I therapy was performed for all the patients before performing the gingival depigmentation procedures with laser and scalpel on a split-mouth basis. Patients were evaluated for pain (1 day, 1 week), wound healing and melanin repigmentation (Melanin Pigmentation Index) immediately and at 1 week, 1 month and 3 months, respectively. Results: The final results were statistically analyzed and significance was evaluated. The results of this study indicated that both scalpel and laser were efficient for gingival depigmentation. Comparative pain assessment (P = 0.148) and repigmentation scores (P = 0.288) at various time intervals between the two groups did not show any statistical significance. Conclusion: Both the procedures did not result in any post-operative complications and the gingiva healed uneventfully. When compared, both the techniques were found to be equally efficacious. Care must be taken to assess the gingival biotype and the degree of pigmentation in deciding which technique is to be used. Clinical Significance: Various methods of depigmentation are available with comparable efficacies. Depigmentation is not a clinical indication but a treatment of choice where esthetics is a concern and is desired by the patient. PMID:25425820

  4. A Prospective Six-Year Clinical Study Evaluating Reinforced Glass Ionomer Cements with Resin Coating on Posterior Teeth: Quo Vadis?

    PubMed

    Türkün, L S; Kanik, Ö

    The aim of this study was to evaluate the long-term clinical performance of two encapsulated glass ionomer cements (GICs) (EquiaFil and Riva SC) covered with two different coatings (Equia Coat and Fuji Varnish) over six years using modified US Public Health Service (USPHS) criteria. Fifty-four patients having class I and II restorations/caries were included in the study. A total of 256 restorations were made with EquiaFil and Riva SC. Equia Coat or Fuji Varnish was used randomly on the surface of the restorations. After cavity preparations, the teeth were randomly restored with one GIC and coated with Equia Coat or Fuji Varnish. The restorations were evaluated at baseline; six, 12, and 18 months; and six years after placement using modified USPHS criteria. Two evaluators checked color match, marginal discoloration, marginal adaptation, caries formation, anatomical form, postoperative sensitivity, and retention rate, and photographs were taken at each recall. The results were evaluated with Pearson chi-square and Mann-Whitney U-test (p<0.05). Thirty-seven patients were evaluated. There was a significant difference between EquiaFil and Riva SC regarding retention rate and color match after six years (p=0.033 and 0.046). When comparing baseline to six years, the overall success of EquiaFil was better than Riva SC, having significant problems regarding retention rate and anatomical form (p=0.016 and 0.031). Class II cavities were significantly worse in marginal adaptation, anatomical form, and retention rate in the Riva SC groups (p=0.033, 0.015, and 0.007) but not in the EquiaFil groups. The combination of the coatings had no effect on the overall success of the materials. The EquiaFil system was more successful than Riva SC regarding color match, marginal adaptation, anatomic form, and retention rate after a six-year clinical evaluation period.

  5. Evaluation of a bioresorbable collagen membrane of fish origin in the treatment of periodontal intrabony defects: A prospective clinical study

    PubMed Central

    Santosh Kumar, B.B.; Aruna, D.R.; Gowda, S. Vinayak; Galagali, R. Sushama

    2013-01-01

    Background: Recently, there has been interest in non-mammalian collagen sources such as fish collagen in the development of biomatrices and scaffolds for periodontal regeneration. In the present study, a novel collagen barrier membrane of fish origin was assessed in the treatment of periodontal intra-bony defects. Materials and Methods: Ten systemically healthy chronic periodontitis patients having an osseous defect in the mandibular posterior teeth were selected and following the open flap debridement, a collagen membrane was placed over the defect and the flap was sutured with interrupted sutures. Clinical parameters such as Plaque Index, Gingival Bleeding Index, probing pocket depth (PPD), relative attachment level (RAL), and recession (R) were recorded at baseline, 6 and 9 months, whereas radiographic evaluation was done to assess alveolar crestal bone level and defect depth fill at 6 and 9 months using Auto-computer aided design (ACAD) 2007 software. Statistical significance was set at 5% level of significance. Results: There was statistical significant differences with respect to periodontal clinical parameters such as Plaque Index, Gingival Bleeding Index, PPD, RAL, and gingival recession assessed at baseline, at 6 and 9 months respectively (P < 0.05), and radiographic evaluation showed a defect fill of 58.62 median % at 9 months. Conclusion: This preliminary study has shown predictable results in using fish collagen membrane, for treating periodontal intra-bony defects. Further, long-term clinical trials are needed to validate the effectiveness of this membrane. PMID:23946741

  6. Evaluation and comparison of white mineral trioxide aggregate and formocresol medicaments in primary tooth pulpotomy: clinical and radiographic study.

    PubMed

    Jayam, Cheranjeevi; Mitra, Malay; Mishra, Jiban; Bhattacharya, Bhaswar; Jana, Biswanath

    2014-01-01

    The primary aim of the following study is to evaluate and secondary aim is to compare clinically and radiographically the success of using white mineral trioxide aggregate (MTA) versus formocresol (FC) medicament for primary tooth pulpotomy. A total of 100 teeth were selected for pulpotomy; of which 50 teeth underwent FC pulpotomy and 50 teeth underwent pulpotomy with white MTA. Out of 100 treated teeth, 82 teeth (42 FC and 40 MTA teeth) were available at the end of 24 months for evaluation. 4 failures were found in FC group at 1 st month evaluation and no failures were found in white MTA group. A statistical analysis was performed to evaluate the overall success rate of study and individual success rates of medicaments. Overall success rate of the study was 95%, success rate of FC group was 90.48% and success rate of MTA group was 100%. MTA produced better results as pulpotomy medicament in comparison to FC. The superior success obtained in the present study was matching other studies mentioned in the literature. MTA seems to be a promising pulpotomy medicament for future use.

  7. Ahmed glaucoma valve in post-penetrating-keratoplasty glaucoma: A critically evaluated prospective clinical study

    PubMed Central

    Panda, Anita; Prakash, Vadivelu Jaya; Dada, Tanuj; Gupta, Anoop Kishore; Khokhar, Sudarshan; Vanathi, Murugesan

    2011-01-01

    Aim: The aim was to evaluate the outcome of Ahmed glaucoma valve (AGV) in post-penetrating-keratoplasty glaucoma (PKPG). Materials and Methods: In this prospective study, 20 eyes of 20 adult patients with post-PKPG with intraocular pressure (IOP) >21 mmHg, on two or more antiglaucoma medications, underwent AG (model FP7) implantation and were followed up for a minimum of 6 months. Absolute success was defined as 5

  8. Comparative Evaluation of Gingival Depigmentation by Tetrafluroethane Cryosurgery and Surgical Scalpel Technique. A Randomized Clinical Study.

    PubMed

    Narayankar, Suraj D; Deshpande, Neeraj C; Dave, Deepak H; Thakkar, Dhaval J

    2017-01-01

    Importance of good smile cannot be underestimated in enhancement of beauty, self-confidence and personality of a person. Health and appearance of gingiva is an essential part of attractive smile. Gingival pigmentation gives rise to unesthetic smile line. In present world, with increasing awareness to esthetic, people have become highly concerned about black gums. Various treatment modalities like abrasion, scrapping, scalpel technique, cryosurgery, electrosurgery and laser are available for treatment of gingival pigmentation. The present study was conducted with an objective of comparing efficacy of gingival depigmentation by cryosurgery and scalpel technique. A Randomized control split mouth study was conducted for 25 patients with gingival pigmentation. Gingival pigmentation Index (GPI) for pigmentation and Visual Analoug Scale (VAS) for pain was evaluated for both test (Cryosurgery) and control sites (Scalpel technique) at baseline, 1month, 3months and 6 months. GPI score was 3 and 2 for 21/25 and 4/25 control sites and was 22/25 and 3/25 test sites respectively at baseline. Both the groups showed significant reduction in GPI score i.e., 0 at 1 and 3 months interval after treatment. GPI score increased to 1 for 5/25 sites treated with scalpel technique and 2/25 sites treated with cryosurgery at 6 months interval (P =0.0691). This indicates recurrence rate for pigmentation is higher after scalpel treatment. VAS Score was 3 for 10/25 sites treated with scalpel and was 2 for 12/25 sites treated with cryosurgery (P <0.001). It can be concluded that cryosurgery can be effectively and efficiently used for depigmentation by keeping patients acceptance and comfort in mind and also the long term results and ease of use when compared to scalpel technique.

  9. Clinical Evaluation of Removable Partial Dentures on the Periodontal Health of Abutment Teeth: A Retrospective Study

    PubMed Central

    Dula, Linda J; Ahmedi, Enis F; Lila-Krasniqi, Zana D; Shala, Kujtim Sh

    2015-01-01

    The aim of this retrospective study was to evaluate the effect of removable partial dentures in periodontal abutment teeth in relation to the type of denture support and design of RPD in a five-year worn period. Methods : A total of 64 patients with removable partial dentures (RPDs), participated in this study. It were examined ninety-one RPDs. There were seventy-five RPDs with clasp-retained and sixteenth were RPDs with attachments. There were 28 females and 36 males, aged between 40-64 years, 41 maxillary and 50 mandible RPDs. For each subjects the following data were collected: denture design, denture support, and Kennedy classification. Abutment teeth were assessed for plaque index (PI), calculus index (CI), blending on probing (BOP), probing depth (PD), gingival recession (GR), tooth mobility (TM). Level of significance was set at p<0.05. Results : According to denture support of RPD, BOP, PD, PI, GR, CI and TM-index showed no statistically significant difference. Based on the denture design of RPD’s, BOP, PD, PI, CI, and TM-index proved no statistically significant difference. Except GR-index according to denture design confirmed statistically significant difference in RPD with clasp p<0.01. The higher values of all periodontal parameter as BOP, PD, PI, CI and TM were in patients with RPD’s with claps comparing with RPD’s with attachment. Conclusion : RPD’s with clasp increased level of gingival inflammation in regions covered by the dentures and below the clasp arms in abutment teeth. PMID:25926896

  10. Studies on the traditional herbal anthelmintic Chenopodium ambrosioides L.: ethnopharmacological evaluation and clinical field trials.

    PubMed

    Kliks, M M

    1985-01-01

    Infusions and decoctions of the leaves, roots and inflorescences of the herbaceous shrub Chenopodium ambrosioides (American wormseed, goosefoot, epazote, paico) and related species indigenous to the New World have been used for centuries as dietary condiments and as traditional anthelmintics by native peoples for the treatment of intestinal worms. Commercial preparations of oil of chenopodium and its active constituent, ascaridol, obtained by steam distillation, have been and continue to be, used with considerable success in mass treatment campaigns. Ethnopharmacological studies in a community of Mayan subsistence farmers in Chiapas, Mexico, confirmed that decoctions containing up to 300 mg of dry plant material per kg body weight (MGKGW) were widely used and traditionally highly regarded in the treatment of ascariasis. However, therapeutic doses of up to 6000 MGKGW of powdered, dried plant had no significant anthelmintic effect on the adults of Necator, Trichuris of Ascaris. Gas-liquid chromatographic analyses of plant samples used consistently demonstrated the presence of ascaridol in the expected amounts. Possible origins of subjective belief in the efficacy of C. ambrosioides as used, may be related to the positive association of spontaneous, or peristalsis-induced passage of senescent worms immediately following a therapeutic episode. It is also possible that in the past varieties of the plant containing much more ascaridol were used. The results of these controlled field studies did not sustain widely held traditional beliefs, nor the value of therapeutic practices regarding this plant. It is, therefore, essential that all indigenous ethnomedical practices be objectively evaluated for efficacy and safety using appropriate protocols before being considered for adoptation or promotion in health care programs.(ABSTRACT TRUNCATED AT 250 WORDS)

  11. Lymph node evaluation for colon cancer in routine clinical practice: a population-based study

    PubMed Central

    Del Paggio, J.C.; Nanji, S.; Wei, X.; MacDonald, P.H.; Booth, C.M.

    2017-01-01

    Background Guidelines recommend that 12 or more lymph nodes (lns) be evaluated during surgical resection of colon cancer. Here, we report ln yield and its association with survival in routine practice. Methods Electronic records of treatment were linked to the population-based Ontario Cancer Registry to identify all patients with colon cancer treated during 2002–2008. The study population (n = 5508) included a 25% random sample of patients with stage ii or iii disease. Modified Poisson regression was used to identify factors associated with ln yield; Cox models were used to explore the association between ln yield and overall (os) and cancer-specific survival (css). Results During 2002–2008, median ln yield increased to 17 from 11 nodes (p < 0.001), and the proportion of patients with 12 or more nodes evaluated increased to 86% from 45% (p < 0.001). Lymph node positivity did not change over time (to 53% from 54%, p = 0.357). Greater ln yield was associated with younger age (p < 0.001), less comorbidity (p = 0.004), higher socioeconomic status (p = 0.001), right-sided tumours (p < 0.001), and higher hospital volume (p < 0.001). In adjusted analyses, a ln yield of less than 12 nodes was associated with inferior os and css for stages ii and iii disease [stage ii os hazard ratio (hr): 1.36; 95% confidence interval (ci): 1.19 to 1.56; stage ii css hr: 1.52; 95% ci: 1.26 to 1.83; and stage iii os hr: 1.45; 95% ci: 1.30 to 1.61; stage iii css hr: 1.54; 95% ci: 1.36 to 1.75]. Conclusions Despite a temporal increase in ln yield, the proportion of cases with ln positivity has not changed. Lymph node yield is associated with survival in patients with stages ii and iii colon cancer. The association between ln yield and survival is unlikely to be a result of stage migration. PMID:28270730

  12. Evaluating clinical periodontal measures as surrogates for bacterial exposure: The Oral Infections and Vascular Disease Epidemiology Study (INVEST)

    PubMed Central

    2010-01-01

    Background Epidemiologic studies of periodontal infection as a risk factor for cardiovascular disease often use clinical periodontal measures as a surrogate for the underlying bacterial exposure of interest. There are currently no methodological studies evaluating which clinical periodontal measures best reflect the levels of subgingival bacterial colonization in population-based settings. We investigated the characteristics of clinical periodontal definitions that were most representative of exposure to bacterial species that are believed to be either markers, or themselves etiologic, of periodontal disease. Methods 706 men and women aged ≥ 55 years, residing in northern Manhattan were enrolled. Using DNA-DNA checkerboard hybridization in subgingival biofilms, standardized values for Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Treponema denticola and Tannerella forsythia were averaged within mouth and summed to define "bacterial burden". Correlations of bacterial burden with clinical periodontal constructs defined by the severity and extent of attachment loss (AL), pocket depth (PD) and bleeding on probing (BOP) were assessed. Results Clinical periodontal constructs demonstrating the highest correlations with bacterial burden were: i) percent of sites with BOP (r = 0.62); ii) percent of sites with PD ≥ 3 mm (r = 0.61); and iii) number of sites with BOP (r = 0.59). Increasing PD or AL severity thresholds consistently attenuated correlations, i.e., the correlation of bacterial burden with the percent of sites with PD ≥ 8 mm was only r = 0.16. Conclusions Clinical exposure definitions of periodontal disease should incorporate relatively shallow pockets to best reflect whole mouth exposure to bacterial burden. PMID:20056008

  13. Case study of evaluations that go beyond clinical outcomes to assess quality improvement diabetes programmes using the Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE)

    PubMed Central

    Harris, Stewart B.; Naqshbandi Hayward, Mariam; Tompkins, Jordan W.

    2016-01-01

    Abstract Rationale, aims and objectives Investments in efforts to reduce the burden of diabetes on patients and health care are critical; however, more evaluation is needed to provide evidence that informs and supports future policies and programmes. The newly developed Diabetes Evaluation Framework for Innovative National Evaluations (DEFINE) incorporates the theoretical concepts needed to facilitate the capture of critical information to guide investments, policy and programmatic decision making. The aim of the study is to assess the applicability and value of DEFINE in comprehensive real‐world evaluation. Method Using a critical and positivist approach, this intrinsic and collective case study retrospectively examines two naturalistic evaluations to demonstrate how DEFINE could be used when conducting real‐world comprehensive evaluations in health care settings. Results The variability between the cases and the evaluation designs are described and aligned to the DEFINE goals, steps and sub‐steps. The majority of the theoretical steps of DEFINE were exemplified in both cases, although limited for knowledge translation efforts. Application of DEFINE to evaluate diverse programmes that target various chronic diseases is needed to further test the inclusivity and built‐in flexibility of DEFINE and its role in encouraging more comprehensive knowledge translation. Conclusions This case study shows how DEFINE could be used to structure or guide comprehensive evaluations of programmes and initiatives implemented in health care settings and support scale‐up of successful innovations. Future use of the framework will continue to strengthen its value in guiding programme evaluation and informing health policy to reduce the burden of diabetes and other chronic diseases. PMID:26804339

  14. Evaluation of continuous arch and segmented arch leveling techniques in adult patients--a clinical study.

    PubMed

    Weiland, F J; Bantleon, H P; Droschl, H

    1996-12-01

    The purpose of this study was to compare the efficacy of overbite correction achieved by a conventional continuous arch wire technique and the segmented arch technique as recommended by Burstone. The sample comprised 50 adult patients (age 18 to 40 years) with deep bites. Twenty-five patients were treated with a continuous arch wire technique (CAW); in the second half of the sample, the segmented arch technique (Burstone) was used for correction of the vertical malocclusion. Lateral cephalograms and plaster cast models taken before and immediately after treatment were evaluated. Statistical analysis was performed on the collected data. The results showed that both techniques produced a highly significant overbite reduction (CAW: -3.17 mm, p < 0.001; Burstone: -3.56 mm, p < 0.001). The CAW group showed an extrusion in the molar area with subsequent posterior rotation of the mandible (6occl-ML: +1.30 mm; 6occl-NSL: +1.63 mm; ML/NSL: +1.94 degrees, all p < 0.001). The Burstone group, however, showed overbite reduction by incisor intrusion without any substantial extrusion of posterior teeth (upper 1-NSL: -1.50 mm; lower 1-ML: -1.72 mm; both p < 0.001). As a consequence, no significant posterior rotation of the mandible took place (ML/NSL: +0.52 degrees, n.s.). It is concluded that in adult patients the segmented arch technique (Burstone) can be considered as being superior to a conventional continuous arch wire technique if arch leveling by incisor intrusion is indicated.

  15. Importance of yawning in the evaluation of excessive daytime sleepiness: a prospective clinical study.

    PubMed

    Catli, Tolgahan; Acar, Mustafa; Hanci, Deniz; Arikan, Osman Kursat; Cingi, Cemal

    2015-12-01

    As a dark and not fully understood side of human nature, yawning is believed to be a signs of various physiological or pathological behaviors of human. In this study, we aimed to investigate the importance of yawning in the evaluation of sleepiness. One hundred and twenty-nine snorers who were suspected to have obstructive sleep apnea syndrome underwent polysomnography and were asked to fill the Epworth sleepiness scale. The number of yawnings of patients was counted during the day following polysomnography. Patients were stratified into two groups: those have apnea hypopnea index <5 (n = 43, group 1) and those have apnea hypopnea index >30 (n = 86, group 2). Mean duration of sleep phases, oxygen saturations, sleep efficacies, yawning frequencies and Epworth scores of the groups were compared. Correlations of yawning frequency with Epworth scores, duration of sleep phases and mean oxygen saturations were investigated. Sleep efficacies were similar between the groups (p > 0.05). Yawning frequencies in group 1 and group 2 were 43.48 and 75.76 (mean rank), respectively (p < 0.01). Mean N1, N2, N3 phase durations and oxygen saturations were significantly lower in group 2 (p < 0.01). While there was a negative correlation between yawning frequency and duration of the non-REM phases and mean oxygen saturation (r = -0.53 and r = -0.31, respectively, p < 0.05), yawning frequency was positively correlated with Epworth scores (r = 0.46, p < 0.05). In addition to the shortened phases of sleep, increased Epworth score and decreased oxygen saturation, increased yawning frequency may indicate sleep deprivation.

  16. Recurrent hyperparathyroidism: a study of 3 cases with evaluation of some pathogenetic and clinical aspects.

    PubMed Central

    Mazzuoli, G.; Minisola, S.; Scarda, A.; De Matteis, A.; Tabolli, S.; Bigi, F.; Valtorta, C.; D'Erasmo, E.

    1987-01-01

    Three patients with recurrent hyperparathyroidism (15, 8 and 3 years respectively, after the first operation) are described in order to establish the causes and define the clinical characteristics of the disease. The observation that in the present series recurrent hyperparathyroidism was associated either with an adenoma (two cases) or a carcinoma (one case), appears to stress the possibility of the pathological involvement of one gland even though recurrent hyperparathyroidism should be considered due to the chronic extrinsic stimulation of the parathyroid glands. The severity of the clinical and metabolic picture observed at the time of the first diagnosis and/or at the time of recurrence together with the simultaneous presence of bone and stone disease in the patients described is of particular interest. The cases reported underline the importance of carrying out careful metabolic investigations in patients with hyperparathyroidism not only before but also for a prolonged period of time after operation. PMID:3671259

  17. Asian diabetics attending a British hospital clinic: a pilot study to evaluate their care.

    PubMed Central

    Hawthorne, K

    1990-01-01

    A questionnaire survey of 40 Asian and 31 British non-insulin dependent diabetics attending a hospital clinic showed that both groups remembered receiving education about diabetes (90%) but Asian diabetics knew less about glucose monitoring and diabetic complications. Asians also had a more negative attitude towards the clinic, feeling they were made to wait longer than the British. They were frustrated by a lack of communication with the staff. Forty per cent of both Asian and British diabetics felt that diabetes prevented them from leading a normal lifestyle. Twenty seven per cent of both Asian and British diabetics used herbal or alternative medicines, but Asians differed in that they used these medicines specifically for diabetes. A further sample of 50 Asians had poorer glycaemic control than a sample of British diabetics matched for age, sex and type of diabetes. It is concluded that despite receiving the same education as British diabetics, Asians did not understand it as well. The education was often not relevant to their diets or customs. This may contribute to their poorer glycaemic control. Diabetic clinic facilities need to be improved for Asian diabetics, to improve their understanding of diabetes. PMID:2117948

  18. COMBAT study - Computer based assessment and treatment - A clinical trial evaluating impact of a computerized clinical decision support tool on pain in cancer patients.

    PubMed

    Raj, Sunil X; Brunelli, Cinzia; Klepstad, Pål; Kaasa, Stein

    2017-08-08

    The prevalence of pain in cancer patients are relatively high and indicate inadequate pain management strategies. Therefore, it is necessary to develop new methods and to improve implementation of guidelines to assess and treat pain. The vast improvement in information technology facilitated development of a computerized symptom assessment and decision support system (CCDS) - the Combat system - which was implemented in an outpatient cancer clinic to evaluate improvement in pain management. We conducted a controlled before-and-after study between patient cohorts in two consecutive study periods: before (n=80) and after (n=134) implementation of the Combat system. Patients in the first cohort completed questionnaires with the paper-and-pencil method and this data was not shown to physicians. Patients in the latter cohort completed an electronic questionnaire by using an iPad and the data were automatically transferred and presented to physicians at point of care. Additionally, the system provided computerized decision support at point of care for the physician based on the electronic questionnaires completed by the patients, an electronic CRF completed by physicians and clinical guidelines. The Combat system did not improve pain intensity and there were no significant alterations in the prescribed dose of opiates compared to the cohort of patients managed without the Combat system. The Combat system did not improve pain management. This may be explained by several factors, however, we consider lack of proper implementation of the CCDS in the clinic to be the most important factor. As a result, we did not manage to change the behaviour of the physicians in the clinic. There is a need to conduct larger prospective studies to evaluate the efficacy of modern information technology to improve pain management in cancer patients. Before introducing new information technology in the clinics, it is important to have a well thought out implementation strategy. The trial is

  19. Generation and evaluation of 3D digital casts of maxillary defects based on multisource data registration: A pilot clinical study.

    PubMed

    Ye, Hongqiang; Ma, Qijun; Hou, Yuezhong; Li, Man; Zhou, Yongsheng

    2017-04-25

    Digital techniques are not clinically applied for 1-piece maxillary prostheses containing an obturator and removable partial denture retained by the remaining teeth because of the difficulty in obtaining sufficiently accurate 3-dimensional (3D) images. The purpose of this pilot clinical study was to generate 3D digital casts of maxillary defects, including the defective region and the maxillary dentition, based on multisource data registration and to evaluate their effectiveness. Twelve participants with maxillary defects were selected. The maxillofacial region was scanned with spiral computer tomography (CT), and the maxillary arch and palate were scanned using an intraoral optical scanner. The 3D images from the CT and intraoral scanner were registered and merged to form a 3D digital cast of the maxillary defect containing the anatomic structures needed for the maxillary prosthesis. This included the defect cavity, maxillary dentition, and palate. Traditional silicone impressions were also made, and stone casts were poured. The accuracy of the digital cast in comparison with that of the stone cast was evaluated by measuring the distance between 4 anatomic landmarks. Differences and consistencies were assessed using paired Student t tests and the intraclass correlation coefficient (ICC). In 3 participants, physical resin casts were produced by rapid prototyping from digital casts. Based on the resin casts, maxillary prostheses were fabricated by using conventional methods and then evaluated in the participants to assess the clinical applicability of the digital casts. Digital casts of the maxillary defects were generated and contained all the anatomic details needed for the maxillary prosthesis. Comparing the digital and stone casts, a paired Student t test indicated that differences in the linear distances between landmarks were not statistically significant (P>.05). High ICC values (0.977 to 0.998) for the interlandmark distances further indicated the high

  20. Robotic and clinical evaluation of upper limb motor performance in patients with Friedreich's Ataxia: an observational study.

    PubMed

    Germanotta, Marco; Vasco, Gessica; Petrarca, Maurizio; Rossi, Stefano; Carniel, Sacha; Bertini, Enrico; Cappa, Paolo; Castelli, Enrico

    2015-04-23

    Friedreich's ataxia (FRDA) is the most common hereditary autosomal recessive form of ataxia. In this disease there is early manifestation of gait ataxia, and dysmetria of the arms and legs which causes impairment in daily activities that require fine manual dexterity. To date there is no cure for this disease. Some novel therapeutic approaches are ongoing in different steps of clinical trial. Development of sensitive outcome measures is crucial to prove therapeutic effectiveness. The aim of the study was to assess the reliability and sensitivity of quantitative and objective assessment of upper limb performance computed by means of the robotic device and to evaluate the correlation with clinical and functional markers of the disease severity. Here we assess upper limb performances by means of the InMotion Arm Robot, a robot designed for clinical neurological applications, in a cohort of 14 children and young adults affected by FRDA, matched for age and gender with 18 healthy subjects. We focused on the analysis of kinematics, accuracy, smoothness, and submovements of the upper limb while reaching movements were performed. The robotic evaluation of upper limb performance consisted of planar reaching movements performed with the robotic system. The motors of the robot were turned off, so that the device worked as a measurement tool. The status of the disease was scored using the Scale for the Assessment and Rating of Ataxia (SARA). Relationships between robotic indices and a range of clinical and disease characteristics were examined. All our robotic indices were significantly different between the two cohorts except for two, and were highly and reliably discriminative between healthy and subjects with FRDA. In particular, subjects with FRDA exhibited slower movements as well as loss of accuracy and smoothness, which are typical of the disease. Duration of Movement, Normalized Jerk, and Number of Submovements were the best discriminative indices, as they were

  1. Evaluation of the efficiency of biofield diagnostic system in breast cancer detection using clinical study results and classifiers.

    PubMed

    Subbhuraam, Vinitha Sree; Ng, E Y K; Kaw, G; Acharya U, Rajendra; Chong, B K

    2012-02-01

    The division of breast cancer cells results in regions of electrical depolarisation within the breast. These regions extend to the skin surface from where diagnostic information can be obtained through measurements of the skin surface electropotentials using sensors. This technique is used by the Biofield Diagnostic System (BDS) to detect the presence of malignancy. This paper evaluates the efficiency of BDS in breast cancer detection and also evaluates the use of classifiers for improving the accuracy of BDS. 182 women scheduled for either mammography or ultrasound or both tests participated in the BDS clinical study conducted at Tan Tock Seng hospital, Singapore. Using the BDS index obtained from the BDS examination and the level of suspicion score obtained from mammography/ultrasound results, the final BDS result was deciphered. BDS demonstrated high values for sensitivity (96.23%), specificity (93.80%), and accuracy (94.51%). Also, we have studied the performance of five supervised learning based classifiers (back propagation network, probabilistic neural network, linear discriminant analysis, support vector machines, and a fuzzy classifier), by feeding selected features from the collected dataset. The clinical study results show that BDS can help physicians to differentiate benign and malignant breast lesions, and thereby, aid in making better biopsy recommendations.

  2. Association between frequent cardiac resynchronization therapy optimization and long-term clinical response: a post hoc analysis of the Clinical Evaluation on Advanced Resynchronization (CLEAR) pilot study

    PubMed Central

    Delnoy, Peter Paul; Ritter, Philippe; Naegele, Herbert; Orazi, Serafino; Szwed, Hanna; Zupan, Igor; Goscinska-Bis, Kinga; Anselme, Frederic; Martino, Maria; Padeletti, Luigi

    2013-01-01

    Aims The long-term clinical value of the optimization of atrioventricular (AVD) and interventricular (VVD) delays in cardiac resynchronization therapy (CRT) remains controversial. We studied retrospectively the association between the frequency of AVD and VVD optimization and 1-year clinical outcomes in the 199 CRT patients who completed the Clinical Evaluation on Advanced Resynchronization study. Methods and results From the 199 patients assigned to CRT-pacemaker (CRT-P) (New York Heart Association, NYHA, class III/IV, left ventricular ejection fraction <35%), two groups were retrospectively composed a posteriori on the basis of the frequency of their AVD and VVD optimization: Group 1 (n = 66) was composed of patients ‘systematically’ optimized at implant, at 3 and 6 months; Group 2 (n = 133) was composed of all other patients optimized ‘non-systematically’ (less than three times) during the 1 year study. The primary endpoint was a composite of all-cause mortality, heart failure-related hospitalization, NYHA functional class, and Quality of Life score, at 1 year. Systematic CRT optimization was associated with a higher percentage of improved patients based on the composite endpoint (85% in Group 1 vs. 61% in Group 2, P < 0.001), with fewer deaths (3% in Group 1 vs. 14% in Group 2, P = 0.014) and fewer hospitalizations (8% in Group 1 vs. 23% in Group 2, P = 0.007), at 1 year. Conclusion These results further suggest that AVD and VVD frequent optimization (at implant, at 3 and 6 months) is associated with improved long-term clinical response in CRT-P patients. PMID:23493410

  3. An evaluation of different caries removal techniques in primary teeth: a comparitive clinical study.

    PubMed

    Kochhar, Gulsheen Kaur; Srivastava, Nikhil; Pandit, I K; Gugnani, Neeraj; Gupta, Monika

    2011-01-01

    To compare the efficacy of caries removal, time taken and to evaluate the pain threshold experienced by the patient during various caries removal methods. Eighty patients between the age groups of 5-9 years were selected and caries removal was done by hand instruments, airotor, carisolv and papacarie. The efficacy, time taken and the pain threshold was evaluated during the caries removal by Ericson D et al scale, visual analogue scale respectively. Highly significant relation (< 0.05) was observed when intergroup comparison was made using one way analysis of variance (ANOVA). It was concluded that chemomechanical removal of caries with Papacarie and Carisolv were found to be effective measures of caries removal and could be considered as viable alternatives to painful procedures like Airotor in management of dental caries especially in children.

  4. A Prospective Study of the Clinical Profile, Outcome and Evaluation of D-dimer in Cerebral Venous Thrombosis

    PubMed Central

    Dharanipragada, Subrahmanyam; Basu, Debdatta; Ananthakrishnan, Ramesh; Surendiran, Deepanjali

    2016-01-01

    Introduction Cerebral Venous Thrombosis (CVT) is a well known disease with diverse clinical presentation and causes. With advances in neuroimaging and changing lifestyles, the clinical profile and causes of CVT are changing. D-dimer has been studied in early diagnosis of CVT with variable results. This prospective study was carried out to assess the clinical profile of CVT and role of D-dimer in diagnosis of CVT. Aim To study various aspects of CVT and role of D-dimer. Materials and Methods The study period was September 2012 to July 2014 and included 80 imaging proven patients of CVT. We also included 39 controls for assessing D-dimer. Data was collected according to a preformed format. D-dimer was assessed by a rapid semi-quantitative latex agglutination assay. Discharged patients were followed up to six months. Results Of the total 44 were women and 36 were men (F: M=1.2:1). The mean age of the patients was 29.5±9.68 years. Most common clinical features were headache 77 (96.25%), papilloedema (67.5%) and seizures 51 (63.75%). Pregnancy was the most common cause of CVT. Superior sagittal and transverse sinuses were the most common sinuses to be affected. The sensitivity and specificity of D-dimer for diagnosing CVT was 84.62% and 80% respectively. The risk factors for poor prognosis were altered sensorium, presence of sepsis, increased sinus involvement and deep sinus thrombosis. Conclusion CVT affects both sexes equally. Puerperium still contributes to majority of the cases. Iron deficiency anaemia needs to be evaluated as a contributing factor for incidence of CVT. D-dimer is not useful in puerperal female with CVT. Positive D-dimer will strengthen the suspicion of CVT in patients with acute headache followed by a neurological deficit. PMID:27504325

  5. Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study.

    PubMed

    Lalor, Joan G; Casey, Dympna; Elliott, Naomi; Coyne, Imelda; Comiskey, Catherine; Higgins, Agnes; Murphy, Kathy; Devane, Declan; Begley, Cecily

    2013-04-08

    The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed 'different', and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Multiple approaches to data collection are needed to evaluate the impact

  6. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study

    PubMed Central

    Bhatt, Manohar; Purohit, Kanchan; Acharya, Jitendra; Kumar, Rajesh; Garg, Rakesh

    2017-01-01

    Many plants with biological and antimicrobiological properties have been studied since there has been a relevant increase in the incidence of antibiotic overuse and misuse. In dentistry, phytomedicines have been used as anti-inflammatory, antibiotic, analgesic, and sedative agents. Turmeric is used extensively in foods for its flavor and color, as well as having a long tradition of use in the Chinese and Ayurvedic systems of medicine, particularly as an anti-inflammatory and for the treatment of flatulence, jaundice, menstrual difficulties, hematuria, hemorrhage, and colic. This article studies ahead with a new idea of using powdered turmeric as a material of pulpotomy procedure in primary teeth. How to cite this article Purohit RN, Bhatt M, Purohit K, Acharya J, Kumar R, Garg R. Clinical and Radiological Evaluation of Turmeric Powder as a Pulpotomy Medicament in Primary Teeth: An in vivo Study. Int J Clin Pediatr Dent 2017;10(1):37-40. PMID:28377653

  7. Clinical evaluation of Cissus quadrangularis as osteogenic agent in maxillofacial fracture: A pilot study

    PubMed Central

    Brahmkshatriya, Hemal R.; Shah, Kruti A.; Ananthkumar, G. B.; Brahmkshatriya, Mansi H.

    2015-01-01

    Introduction: Cissus quadrangularis Linn. is an indigenous medicinal plant, grown in India, which helps to increase healing process of fractured bone. Fracture of maxillofacial skeletal takes reasonably long time to heal. Many attempts have been made till today to reduce the healing period of 6–8 weeks, by means of improved surgical technology or by inhibiting the physiological mechanism of bone healing. Aim: To evaluate the effect of C. quadrangularis in healing process of maxillofacial fracture. Materials and Methods: All the patients were treated by open reduction internal fixation method and in postoperative management, antibiotics, and analgesics. Patients were divided into two groups. In Group 1, one capsule of C. quadrangularis (500 mg) thrice a day for 6 weeks was administered (n = 5), and in Group 2 (control group), no supplementary medication was administered (n = 4). Pain, swelling, fragment mobility, serum calcium, and serum phosphorus were evaluated pre- and post-operatively on day-1, -21, and -45. Results: Pain, swelling, and fragment mobility were low in Group 1 compared to Group 2. Serum calcium and serum phosphorus were also high, and healing of bone was clearly seen in Group 1 on day 21 as compared to control group. Conclusion: C. quadrangularis helps in reducing pain, swelling, and fracture mobility and accelerate the healing of fracture jaw bones. PMID:27011718

  8. Clinical evaluation of Cissus quadrangularis as osteogenic agent in maxillofacial fracture: A pilot study.

    PubMed

    Brahmkshatriya, Hemal R; Shah, Kruti A; Ananthkumar, G B; Brahmkshatriya, Mansi H

    2015-01-01

    Cissus quadrangularis Linn. is an indigenous medicinal plant, grown in India, which helps to increase healing process of fractured bone. Fracture of maxillofacial skeletal takes reasonably long time to heal. Many attempts have been made till today to reduce the healing period of 6-8 weeks, by means of improved surgical technology or by inhibiting the physiological mechanism of bone healing. To evaluate the effect of C. quadrangularis in healing process of maxillofacial fracture. All the patients were treated by open reduction internal fixation method and in postoperative management, antibiotics, and analgesics. Patients were divided into two groups. In Group 1, one capsule of C. quadrangularis (500 mg) thrice a day for 6 weeks was administered (n = 5), and in Group 2 (control group), no supplementary medication was administered (n = 4). Pain, swelling, fragment mobility, serum calcium, and serum phosphorus were evaluated pre- and post-operatively on day-1, -21, and -45. Pain, swelling, and fragment mobility were low in Group 1 compared to Group 2. Serum calcium and serum phosphorus were also high, and healing of bone was clearly seen in Group 1 on day 21 as compared to control group. C. quadrangularis helps in reducing pain, swelling, and fracture mobility and accelerate the healing of fracture jaw bones.

  9. Color changes of esthetic orthodontic ligatures evaluated by orthodontists and patients: a clinical study

    PubMed Central

    Kawabata, Edilene; Dantas, Vera Lucia; Kato, Carlos Brito; Normando, David

    2016-01-01

    ABSTRACT Objective: To evaluate in vivo changes in the color of esthetic elastomeric ligatures from different manufacturers. Methods: Four widely used commercial brands of elastomeric ligatures were selected and used in 20 adult patients in a split-mouth design. The ligatures were evaluated by orthodontists and patients in a double-blind manner on the day the ligatures were placed (T0) and 30 days after intraoral exposure (T1) by means of a system of staining scores. Groups were compared by Friedman test with p < 0.05. Results: Orthodontists and patients reported similar staining scores (p > 0.05). Results showed that all brands underwent significant staining when exposed to the intraoral environment. Modular-crystal MorelliTM (Sorocaba, SP, Brazil) showed the highest degree of staining with the median reaching the maximum value (3); while the other brands (3M UnitekTM, American OrthodonticsTM and GAC DentsplyTM) showed the median equal to 1 (p < 0.001). A large individual variability in the degree of staining was also found for all brands. Conclusions: All four brands of esthetic ligatures showed significant staining, which appeared to be more pronounced for the MorelliTM brand. Changes in color of the elastomeric ligatures were perceived similarly by patients and orthodontists. The industry needs to improve the color stability of esthetic ligatures. PMID:27901229

  10. ["I dreamed that I dreamed": some notes on the clinical evaluation of therapist interventions, exemplified by Deserno's case study (session 290)].

    PubMed

    Berns, U; Hemprich, L

    2001-01-01

    In No. 8, 48th year, August 1998, of the journal "Psychotherapie--Psychosomatik--Medizinische Psychologie" the tape recorder transcription of the 290th session of a long-term analysis was studied by three methods (BIP, Frames, ZBKT). The paper presented here was stimulated by this publication. From the author's viewpoint substantial clinical aspects of evaluation could be added by applying a clinical evaluation method developed by R. Langs and his corresponding concept of interpretation. Clinical vignettes exemplify the possibility to resolve pathological countertransference by using this evaluation method. With the help of this method the presented transcription of the 290th session is evaluated partially.

  11. A clinical evaluation of the RNCA study using Fourier filtering as a preprocessing method

    SciTech Connect

    Robeson, W.; Alcan, K.E.; Graham, M.C.; Palestro, C.; Oliver, F.H.; Benua, R.S.

    1984-06-01

    Forty-one patients (25 male, 16 female) were studied by Radionuclide Cardangiography (RNCA) in our institution. There were 42 rest studies and 24 stress studies (66 studies total). Sixteen patients were normal, 15 had ASHD, seven had a cardiomyopathy, and three had left-sided valvular regurgitation. Each study was preprocessed using both the standard nine-point smoothing method and Fourier filtering. Amplitude and phase images were also generated. Both preprocessing methods were compared with respect to image quality, border definition, reliability and reproducibility of the LVEF, and cine wall motion interpretation. Image quality and border definition were judged superior by the consensus of two independent observers in 65 of 66 studies (98%) using Fourier filtered data. The LVEF differed between the two processes by greater than .05 in 17 of 66 studies (26%) including five studies in which the LVEF could not be determined using nine-point smoothed data. LV wall motion was normal by both techniques in all control patients by cine analysis. However, cine wall motion analysis using Fourier filtered data demonstrated additional abnormalities in 17 of 25 studies (68%) in the ASHD group, including three uninterpretable studies using nine-point smoothed data. In the cardiomyopathy/valvular heart disease group, ten of 18 studies (56%) had additional wall motion abnormalities using Fourier filtered data (including four uninterpretable studies using nine-point smoothed data). We conclude that Fourier filtering is superior to the nine-point smooth preprocessing method now in general use in terms of image quality, border definition, generation of an LVEF, and cine wall motion analysis. The advent of the array processor makes routine preprocessing by Fourier filtering a feasible technologic advance in the development of the RNCA study.

  12. Evaluation of Quantitative Computed Tomography Cortical Hip Quadrant in a Clinical Trial With Rosiglitazone: A Potential New Study Endpoint.

    PubMed

    Miller, Colin G; Bogado, Cesar C; Nino, Antonio J; Northcutt, Allison R; Yu, Hui Jing; Lewiecki, E Michael; Paul, G; Cobitz, Alexander R; Wooddell, Margaret J; Bilezikian, John P; Fitzpatrick, Lorraine A

    2016-10-01

    Quantitative computed tomography (QCT) measurements have been used extensively to ascertain information about bone quality and density due to the 3-dimensional information provided and the ability to segment out trabecular and cortical bones. QCT imaging helps to improve our understanding of the role that each bone compartment plays in the pathogenesis and prognosis of fracture. This study was conducted to explore longitudinal changes in femoral neck (FN) cortical bone structure using both volumetric bone mineral density (vBMD) and cortical shell thickness assessments via QCT in a double-blind, randomized, multicenter clinical trial in postmenopausal women with type 2 diabetes mellitus. This study also examined whether treatment-associated changes in the cortical bone vBMD and thickness in femoral neck quadrants could be evaluated. Subjects were randomized to rosiglitazone (RSG) or metformin (MET) for 52 wk followed by 24 wk of open-label MET. A subset of 87 subjects underwent QCT scans of the hip at baseline, after 52 wk of double-blind treatment, and after 24 wk of treatment with MET using standard full-body computed tomography scanners. All scans were evaluated and analyzed centrally. Cortical vBMD at the FN was precisely segmented from trabecular bone and used to assess a possible therapeutic effect on this bone compartment. QCT analysis showed reductions in adjusted mean percentage change in vBMD and in absolute cortical thickness occurred with RSG treatment from baseline to week 52, whereas changes with MET were generally minimal. The reductions observed during RSG treatment for 1 yr appeared to partially reverse during the open-label MET phase from weeks 52 to 76. The femoral neck quadrant may provide utility as a potential endpoint in clinical trials for the understanding of the therapeutic effect of new entities on cortical bone vs trabecular bone; however, further clinical validation is needed.

  13. Pharmacokinetic study and clinical evaluation of a slow-release 5-fluorouracil implant in pancreatic cancer patients.

    PubMed

    Li, Jing Quan; Yang, Jing Chun; Liang, Jie Xiong; Wang, Shi Liang

    2016-01-01

    The aim of this research was to study the pharmacokinetic characteristics of a slow-release 5-fluorouracil implant as well as to evaluate the clinical drug activity of this preparation in pancreatic cancer patients. Pharmacokinetic characteristics of the slow-release 5-fluorouracil implant were evaluated by examining the half-life time (T1/2) and apparent volume of distribution (Vd) in pancreatic cancer patients; the slow-release 5-fluorouracil implant was administered through interstitial chemotherapy (tumor interstitium implantation). In the drug activity study, 36 locally advanced unresectable pancreatic cancer patients were divided randomly into an experimental treatment group (n=18) and a standard treatment group (n=18). The experimental treatment group was treated with interstitial chemotherapy of a slow-release 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine; the standard treatment group was treated with systemic chemotherapy of gemcitabine. An internal drainage procedure was used when biliary and/or gastrointestinal tract obstruction occurred in the two groups. Clinical benefit response, including pain (visual analogue scale), analgesic drug use, general conditions (Karnofsky performance score), weight changes, and survival status, was observed. T1/2 of the slow-release 5-fluorouracil implant was 5475.8±136.4 min, whereas Vd was 45275.0±1028.6 l. Clinical benefit response in the experimental treatment group was better than that in the standard treatment group. The experimental treatment group had longer median survival time compared with the standard treatment group. The slow-release 5-fluorouracil implant could deliver drugs mainly in the regional area of the tumor and prolong the drug action time; interstitial chemotherapy of a 5-fluorouracil implant combined with systemic chemotherapy of gemcitabine could improve the quality of life and survival status of pancreatic cancer patients. The method was promising and worthy of

  14. Clinical evaluation of contemporary oxygenators.

    PubMed

    Stanzel, Roger D P; Henderson, Mark

    2016-01-01

    Advances in cardiopulmonary bypass equipment have played a critical role in improving outcomes for cardiac surgery patients. Recent advancements include reduced priming volumes, biocompatible coatings and gaseous microemboli handling, as well as the incorporation of an arterial filter into the oxygenator.The purpose of this study was to conduct a comprehensive clinical evaluation of adult oxygenators on the market. Oxygenators assessed included the Sorin Synthesis(®) (n = 30), the Sorin Inspire 6F(®) (n = 10) and Inspire 8F(®) (n = 30), the Terumo FX15(®) (n = 13) and FX25(®) (n = 30), the Maquet Quadrox-i(®) (n = 30) and the Medtronic Fusion(®) (n = 30). Parameters assessed included functional prime volumes, gas exchange, pressure gradients and the effects on patient hematology.The Synthesis had the largest functional prime volume (1426 ml), the FX15 the lowest (956 ml). The Inspire 6F, 8F and Fusion had the greatest O2 transfer. The Sorin oxygenators required the lowest sweep gas flows to obtain a PaCO2 of 40 mmHg. The Sorin oxygenators had the largest pressure gradients. While no differences were observed for hemoglobin and platelet levels post cross-clamp removal, the Sorin Synthesis and Inspire 8F had the largest increases in white blood cell (WBC) counts (122% and 141% of baseline, respectively) and neutrophils (162% and 185% of baseline, respectively).The data demonstrate that no single product is superior in all aspects. The choice of ideal oxygenator depends on the aspect(s) of oxygenator performance the perfusion team believes most clinically acceptable based on available data. © The Author(s) 2015.

  15. Assessment of a clinical performance evaluation tool for use in a simulator-based testing environment: a pilot study.

    PubMed

    Gordon, James A; Tancredi, David N; Binder, William D; Wilkerson, William M; Shaffer, David W

    2003-10-01

    This study assessed a clinical performance evaluation tool for use in a simulator-based testing environment. Twenty-three subjects were evaluated during five standardized encounters using a patient simulator (six emergency medicine students, seven house officers, ten chief resident-fellows). Performance in each 15-minute session was compared with performance on an identical number of oral objective-structured clinical examination (OSCE) sessions used as controls. Each was scored by a faculty rater using a scoring system previously validated for oral certification examinations in emergency medicine (eight skills rated 1-8; passing = 5.75). On both simulator exams and oral controls, chief resident-fellows earned (mean) "passing" scores [sim = 6.4 (95% CI: 6.0-6.8), oral = 6.4 (95% CI: 6.1-6.7)]; house officers earned "borderline" scores [sim = 5.6 (95% CI: 5.2-5.9), oral = 5.5 (95% CI: 5.0-5.9)]; and students earned "failing" scores [sim = 4.3 (95% CI: 3.8-4.7), oral = 4.5 (95% CI: 3.8-5.1)]. There were significant differences among mean scores for the three cohorts, for both oral and simulator test arms (p <.01). In this pilot, a standardized oral OSCE scoring system performed equally well in a simulator-based testing environment.

  16. Immunohistochemical study of skin nerve regeneration after toe-to-finger transplantation: correlations with clinical, quantitative sensory, and electrophysiological evaluations.

    PubMed

    Hsieh, Sung-Tsang; Chu, Nai-Shin

    2004-12-01

    Cutaneous nerve regeneration following toe-to-finger transplantation was studied by immunohistochemical technique using antibody to protein gene product 9.5 (PGP 9.5) which is a specific neuronal marker. By this technique, epidermal and dermal nerves were semi-quantified and the Meissner's corpuscles were quantified. There were also quantitative sensory tests (QST) including pinprick, pressure and temperature, as well as electrophysiological studies including digital nerve sensory conduction, digital nerve somatosensory evoked potentials and sympathetic skin response at the pulp of the transplanted toes. The opposite corresponding normal finger and normal toe served as controls. Study subjects were 20 adult patients with toe-to-finger transplantation for at least one year. A score system was used to quantify the results of histochemical, psychophysiological and electrophysiological studies. Clinically 7 patients had good recovery and 13 patients had poor recovery. Cutaneous nerve regeneration in the transplanted toes was incomplete with epidermal nerve, dermal nerve and the Meissner's corpuscle significantly reduced. The nerve regeneration was correlated with clinical recovery, QST and electrophysiological data. These findings indicate that immunohischemical technique is useful to evaluate skin nerve regeneration following toe-to-finger transplantation, and that although nerve regeneration did occur, it was incomplete and correlated with the severity of hand injury.

  17. Clinical evaluation of microbicide formulations.

    PubMed

    Morrow, Kathleen M; Hendrix, Craig

    2010-12-01

    The clinical evaluation of microbicide formulations presents variable and interacting challenges. Specific domains of acceptability, pharmacokinetics, and toxicity interact with each other to potentially inhibit or enhance a microbicide's efficacy. Each of these is further influenced by application and use parameters in the relative presence (or absence) of vaginal and/or seminal fluids, ultimately impacting effectiveness. Historically, acceptability of formulation and use parameters, and their concomitant behavioral influences, have been considered separately from pharmacokinetics and toxicity. While independent evaluation of these elements is necessary in some respects, we must acknowledge that this approach is not sufficient for the successful development of microbicides. Each needs to be considered in an integrated clinical evaluation strategy. This article presents the rationale for such an approach. This article forms part of a special supplement covering two presentations on clinical evaluation of microbicides from the symposium on "Recent Trends in Microbicide Formulations" held on 25 and 26 January 2010, Arlington, VA. Copyright © 2010 Elsevier B.V. All rights reserved.

  18. Evaluation of oxidative stress in chronic periodontitis patients following systemic antioxidant supplementation: A clinical and biochemical study

    PubMed Central

    Ambati, Manasa; Rani, Koduganti Rekha; Reddy, Panthula Veerendranath; Suryaprasanna, Jammula; Dasari, Rajashree; Gireddy, Himabindu

    2017-01-01

    Context: Oxidative stress is associated with the pathogenesis of many systemic diseases including chronic periodontitis. Periodontal pathogen activated neutrophils liberate the reactive oxygen species (ROS), which causes the destruction of periodontal tissues. Antioxidants modulate the ROS production and inhibit the tissue destruction. Aim: We aimed to evaluate the oxidative stress marker malondialdehyde (MDA) in chronic periodontitis patients following scaling and root planing (SRP) after systemic lycopene supplementation. Materials and Methods: This was an interventional single arm study. Twenty systemically healthy patients with chronic periodontitis were recruited. Clinical parameters modified gingival index, probing depth, clinical attachment loss were recorded, and serum MDA levels were assessed by thiobarbituric acid reactive substances assay. Patients were supplemented with 8 mg lycopene daily for 2 months following SRP treatment. All the parameters were assessed at pretreatment and 2 months and 6 months posttreatment. Results: From pretreatment to posttreatment at 2 months, the mean values of all parameters were reduced. While from 2 to 6 months when lycopene was not administered, an increase in the mean values of all the parameters was observed; however, these values were still below baseline values. Conclusion: There was a reduction in oxidative stress and improvement in clinical parameters following systemic antioxidant therapy along with SRP, which was maintained up to 4 months after discontinuation of lycopene treatment. PMID:28250683

  19. Evaluation of Study and Patient Characteristics of Clinical Studies in Primary Progressive Multiple Sclerosis: A Systematic Review

    PubMed Central

    Ziemssen, T.; Rauer, S.; Stadelmann, C.; Henze, T.; Koehler, J.; Penner, I.-K.; Lang, M.; Poehlau, D.; Baier-Ebert, M.; Schieb, H.; Meuth, S.

    2015-01-01

    Background So far, clinical studies in primary progressive MS (PPMS) have failed to meet their primary efficacy endpoints. To some extent this might be attributable to the choice of assessments or to the selection of the study population. Objective The aim of this study was to identify outcome influencing factors by analyzing the design and methods of previous randomized studies in PPMS patients without restriction to intervention or comparator. Methods A systematic literature search was conducted in MEDLINE, EMBASE, BIOSIS and the COCHRANE Central Register of Controlled Trials (inception to February 2015). Keywords included PPMS, primary progressive multiple sclerosis and chronic progressive multiple sclerosis. Randomized, controlled trials of at least one year’s duration were selected if they included only patients with PPMS or if they reported sufficient PPMS subgroup data. No restrictions with respect to intervention or comparator were applied. Study quality was assessed by a biometrics expert. Relevant baseline characteristics and outcomes were extracted and compared. Results Of 52 PPMS studies identified, four were selected. Inclusion criteria were notably different among studies with respect to both the definition of PPMS and the requirements for the presence of disability progression at enrolment. Differences between the study populations included the baseline lesion load, pretreatment status and disease duration. The rate of disease progression may also be an important factor, as all but one of the studies included a large proportion of patients with a low progression rate. In addition, the endpoints specified could not detect progression adequately. Conclusion Optimal PPMS study methods involve appropriate patient selection, especially regarding the PPMS phenotype and progression rate. Functional composite endpoints might be more sensitive than single endpoints in capturing progression. PMID:26393519

  20. Influence of study design on digital pathology image quality evaluation: the need to define a clinical task.

    PubMed

    Platiša, Ljiljana; Brantegem, Leen Van; Kumcu, Asli; Ducatelle, Richard; Philips, Wilfried

    2017-04-01

    Despite the current rapid advance in technologies for whole slide imaging, there is still no scientific consensus on the recommended methodology for image quality assessment of digital pathology slides. For medical images in general, it has been recommended to assess image quality in terms of doctors' success rates in performing a specific clinical task while using the images (clinical image quality, cIQ). However, digital pathology is a new modality, and already identifying the appropriate task is difficult. In an alternative common approach, humans are asked to do a simpler task such as rating overall image quality (perceived image quality, pIQ), but that involves the risk of nonclinically relevant findings due to an unknown relationship between the pIQ and cIQ. In this study, we explored three different experimental protocols: (1) conducting a clinical task (detecting inclusion bodies), (2) rating image similarity and preference, and (3) rating the overall image quality. Additionally, within protocol 1, overall quality ratings were also collected (task-aware pIQ). The experiments were done by diagnostic veterinary pathologists in the context of evaluating the quality of hematoxylin and eosin-stained digital pathology slides of animal tissue samples under several common image alterations: additive noise, blurring, change in gamma, change in color saturation, and JPG compression. While the size of our experiments was small and prevents drawing strong conclusions, the results suggest the need to define a clinical task. Importantly, the pIQ data collected under protocols 2 and 3 did not always rank the image alterations the same as their cIQ from protocol 1, warning against using conventional pIQ to predict cIQ. At the same time, there was a correlation between the cIQ and task-aware pIQ ratings from protocol 1, suggesting that the clinical experiment context (set by specifying the clinical task) may affect human visual attention and bring focus to their criteria

  1. A comparative evaluation of propolis and 5.0% potassium nitrate as a dentine desensitizer: A clinical study

    PubMed Central

    Purra, Aamir Rashid; Mushtaq, Mubashir; Acharya, Shashi Rashmi; Saraswati, Vidya

    2014-01-01

    Aim: The purpose of this clinical study was to evaluate the efficacy of saturated ethanolic solution of Propolis for the treatment of dentin hypersensitivity. Materials and Methods: Ten patients aged 20-40 years with 156 hypersensitive teeth were selected for a 3-month study. Each patient was subjected to treatment with saturated ethanolic solution of Propolis, 5% potassium nitrate and distilled water. The patients were recalled at seventh day, 2 weeks and 4 weeks for the application of the agent and re-evaluation. The final re-evaluation of the patients was done after 3 months from the first application. The responses of the patients to the test temperatures were converted to a ranking and data was statistically analyzed. A statistical analysis was done using ANOVA and Bonferroni test and Tukey HSD test for multicomparison. Results: The results between the Propolis group and the potassium nitrate group showed no significant difference in the immediate post-treatment period; however, the results were significant at the end of first week and second week. At 4 weeks and 3 months period, a comparison between the groups again showed no significant difference. Conclusion: It was concluded that Propolis was more effective than 5% potassium nitrate in relieving dentinal hypersensitivity and had an immediate and sustained effect. PMID:25210261

  2. Clinical and radiographic evaluation of pulpectomies using three root canal filling materials: an in-vivo study.

    PubMed

    Ramar, K; Mungara, J

    2010-01-01

    Various root canal filling materials are used to preserve a pulpally involved carious primary tooth. But there is no single material so far available to fulfill all the requirements of an ideal root canal filling material for a primary tooth. Hence this study was undertaken to evaluate clinically and radiographically the efficacy of three obturating materials - Calcium hydroxide with Iodoform (METAPEX), Zinc Oxide Eugenol with Iodoform (RC FILL) and Zinc Oxide Eugenol and Calcium hydroxide with Iodoform (ENDOFLAS) for a period of 9 months. Results show ENDOFLAS gave an overall success rate of 95.1%, METAPEX - 90.5% and RC FILL - 84.7%. In our study, we conclude that ENDOFLAS, a mixture of Zinc Oxide Eugenol and Calcium hydroxide with Iodoform fulfills most of the required properties of an ideal root canal filling for primary teeth.

  3. Potential reasons for differences in CAD effectiveness evaluated using laboratory and clinical studies

    NASA Astrophysics Data System (ADS)

    He, Xin; Samuelson, Frank; Zeng, Rongping; Sahiner, Berkman

    2015-03-01

    Research studies have investigated a number of factors that may impact the performance assessment of computer aided detection (CAD) effectiveness, such as the inherent design of the CAD, the image and reader samples, and the assessment methods. In this study, we focused on the effect of prevalence on cue validity (co-occurrence of cue and signal) and learning as potentially important factors in CAD assessment. For example, the prevalence of cases with breast cancer is around 50% in laboratory CAD studies, which is 100 times higher than that in breast cancer screening. Although ROC is prevalence-independent, an observer's use of CAD involves tasks that are more complicated than binary classification, including: search, detection, classification, cueing and learning. We developed models to investigate the potential impact of prevalence on cue validity and the learning of cue validity tasks. We hope this work motivates new studies that investigate previously under-explored factors involved in image interpretation with a new modality in its assessment.

  4. Dental hygienists' evaluation of the usability research study of the Colgate ProClinical A1500 electric toothbrush.

    PubMed

    Hovliaras, Christine; Gatzemeyer, John; Jimenez, Eduardo; Panagakos, Fotinos S

    2015-01-01

    To determine the user experiences among patients of a new electric toothbrush vs. a manual toothbrush. Five dental hygienists were selected to review videotapes demonstrating patient use of their manual toothbrush and the Colgate ProClinical A1500 electric toothbrush. A total of 14 users were videotaped during the three-week duration of this observational study. The dental hygienists were asked to review four assigned user videotapes and then complete a four-page questionnaire sheet for each of them. Each patient participant was reviewed by at least two dental hygienists. The results provide an understanding that there may be differences in the length of time that patients brush their teeth with their manual toothbrush vs. this electric toothbrush. The users of the electric toothbrush appeared to brush in a more concentrated and focused tooth brushing pattern vs. the manual brush. The users did become accustomed to using this electric toothbrush over time and felt an improvement in cleaning efficacy with the product. The observations from the five dental hygienists were consistent with the results of a previously published usability study. The Colgate ProClinical A1500 electric toothbrush, relative to a manual toothbrush, provided an improved brushing experience for the fourteen users whose brushing techniques were evaluated by five dental hygienists who reviewed their videotapes from the usability study.

  5. Toward sound objective evaluation of clinical measures.

    PubMed

    Kraemer, Helena Chmura

    2013-07-01

    The quality of all clinical decision-making, as well as power and precision in clinical research results, depends fundamentally on the quality of the measures used. Yet evaluations of the quality of clinical measures likely to be used either in clinic or research applications are difficult to execute or to critique because the criteria for judging such studies are so ill-defined. Here a set of guidelines is proposed, modeled on CONSORT guidelines for randomized clinical trials, first defining the terms often inconsistently used in the research literature and then identifying certain errors that seem to recur in evaluation studies. Copyright © 2013 American Association for Geriatric Psychiatry. Published by Elsevier Inc. All rights reserved.

  6. A clinical study to evaluate denture adhesive use in well-fitting dentures.

    PubMed

    Munoz, Carlos A; Gendreau, Linda; Shanga, Gilbert; Magnuszewski, Tabetha; Fernandez, Patricia; Durocher, John

    2012-02-01

    The objective of this study was the assessment of retention and stability and functional benefits of denture adhesive applied to well-fitting and well-made dentures. This was a randomized, crossover study to compare two marketed denture adhesives (test cream, Super Poligrip® Free, and test strip, Super Poligrip® Comfort Seal Strips) and an unmarketed cream adhesive (GlaxoSmith Kline Consumer Healthcare) with no adhesive as the negative control. Thirty-six subjects completed the study. One hour after the application of denture adhesive, retention and stability were measured using the Kapur Index and maxillary incisal bite force. Two hours after application, functional tests were used to assess denture movement and peanut particle migration under the denture. Subjects also rated confidence, comfort, satisfaction with dentures, and denture wobble in conjunction with the functional tests. Denture adhesives significantly (p < 0.05) improved retention and stability of well-fitting dentures. Subjects experienced significantly (p < 0.05) fewer dislodgements while eating an apple after adhesive was applied to dentures. Significant (p < 0.05) increases in subjective ratings of confidence and comfort as well as decreases in denture wobble were associated with the use of adhesive. There was significant (p < 0.05) improvement in satisfaction ratings for cream adhesives. A single application of each denture adhesive was well tolerated. The results of this study provide evidence that use of Super Poligrip® denture adhesives can enhance aspects of performance of complete well-fitting dentures as well as provide increased comfort, confidence, and satisfaction with dentures. © 2011 by the American College of Prosthodontists.

  7. The USAFSAM Cardiovascular Disease Followup Study: Clinical Evaluation of Subjects Near Age 43.

    DTIC Science & Technology

    1982-08-01

    Right bundle branch block 2 Terminal IV conduction defect 10 Left bundle branch block 3 Left anterior fascicular block, persistent 2 Unclassified IV... ventricular hypertrophy (EOG only) 8 Septal hypertrophy 3 Myocardial damage 6 Atherosclerotic Coronary Disease 10 Thyroid Enlargement 3 Hypothyroldism 3...early years of the Framingham study (41), electrocardiographic evidence of left ventricular hypertrophy (LVH) in middle-aged people was iden- tified as

  8. Contract grading in clinical evaluation.

    PubMed

    Schoolcraft, V; Delaney, C

    1982-01-01

    The use of contracts in grading clinical performance has provided faculty with a solution to two important problems. One has been how to ensure that students are graded consistently among the various faculty who are grading the same clinical component of a course. The second has been to increase the opportunity for individualized attention to student learning needs. We have been pleased to see all the faculty members increase their input and involvement in the continuing modifications of the contract. Although we have taken the major responsibility for the semi-annual revisions of the contract, other faculty members have been increasingly more explicit in their evaluations and suggestions as their experience with the contract has expanded. Their confidence in this method of clinical evaluation has increased with each semester of use. We plan to continue in the refinement of the instrument and will develop materials for the use of other faculty groups who are interested in developing similar contracts. We are also designing a survey to attempt to discover how widespread is the use of contract grading in clinical areas.

  9. Clinical evaluation of periodontal disease in patients with rheumatoid arthritis: A cross-sectional study.

    PubMed

    Pons-Fuster, Alvaro; Rodríguez Agudo, Consuelo; Galvez Muñoz, Pepe; Saiz Cuenca, Encarna; Pina Perez, Francisca M; Lopez-Jornet, Pia

    2015-10-01

    The aim of this study was to determine the presence of periodontal disease among patients with rheumatoid arthritis (RA) in comparison with a control group. The study included 44 patients diagnosed with RA according to American Rheumatism Association (ARA) criteria, who were attending the Morales Meseguer Hospital Rheumatology Service (Murcia, Spain), and 41 control subjects. Patients younger than 18 years or patients suffering systemic diseases that could affect the immune system were excluded. Age, sex, smoking habits, alcohol consumption, and body mass index were registered. Each patient underwent a full periodontal examination. Bleeding on probing was significantly greater in the RA group (0.9 ± 0.36) than the control (P < .001). The Plaque Index was significantly higher in the RA group (0.76 ± 0.34) versus the control group (0.55 ± 0.2) (P < .001). RA patients showed a 0.13 increased risk of periodontal disease (95% confidence interval, 0.05-0.37). Patients with RA suffered a higher risk of periodontal disease and for this reason these patients must be instructed to intensify their oral hygiene regimes.

  10. Evaluation of clinical safety of conversion to Advagraf therapy in liver transplant recipients: observational study.

    PubMed

    Marin-Gomez, L M; Gomez-Bravo, M A; Alamo-Martinez, J A; Barrera-Pulido, L; Bernal Bellido, C; Suárez Artacho, G; Pascasio, J M

    2009-01-01

    To present the correlation between dosage and plasma concentration of tacrolimus and the consequences for short-term hepatorenal function of conversion to Advagraf (tacrolimus extended-release capsules) in liver transplant recipients. This observational study on adult liver transplant recipients examined tacrolimus levels after conversion to Advagraf therapy. Mean (SD) patient age was 51 (44-59) years. Conversion occurred at 43 (19-85) months posttransplantation, and follow-up was 193 (106.5-243.25) days. Dosage was adjusted milligram for milligram. Levels of tacrolimus, total bilirubin, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase, alkaline phosphatase, and creatinine were recorded on the day before conversion to Advagraf and 1, 3, 6, and months afterward. Of the 79 patients in whom therapy was converted to Advagraf, 31 (39.2%) had alcoholic cirrhosis, 19 (24.1%) had viral disease, 10 (12.7) had mixed disease, 8 (10.1%) had cholestatic disease, 4 (5.1%) had metabolic disease, and 7 (8.8%) had other diseases. Despite no modification of Advagraf dosage during follow-up in most patients, mean tacrolimus levels decreased from the first month after conversion; however, at 6 months after conversion, they tended to equal the initial value. Renal function and liver biochemistry values demonstrated no significant change during follow-up. Although tacrolimus levels decreased initially after conversion to Advagraf therapy, 1:1 conversion is safe for hepatorenal function in liver transplant recipients.

  11. Evaluation of student nurses' perception of preparedness for oral medication administration in clinical practice: a collaborative study.

    PubMed

    Aggar, Christina; Dawson, Sonja

    2014-06-01

    Attainment of oral medication administration skills and competency for student nurses is challenging and medication errors are common. The ability of nurses to master a clinical skill is dependent upon educational instruction and practice. The aim of this study was to evaluate nursing students' perception of preparedness for oral medication administration in two practice environments and determine possible relationship between student demographics and their perceived preparedness for oral medication administration. This was a cross sectional, exploratory study. Eighty-eight second year students from a baccalaureate nursing course from two metropolitan Australian tertiary institutions participated. Student nurses' perception of preparedness for oral medication administration was measured via a self-administered, adapted, and validated questionnaire. The overall mean Total Preparedness Score was 86.2 (range 71-102). There was no significant difference for perceived total preparedness to administer oral medications between the two facilities. Whilst there was no significant relationship established between student demographics and their perceived preparedness to administer oral medications, four single questions related to clinical practice were shown to be significant. Low fidelity simulated teaching environments that incorporate time management and post medication situations, may improve student nurses' perceived preparedness for oral medication administration. Copyright © 2014 Elsevier Ltd. All rights reserved.

  12. Evaluating the Consent Preferences of UK Research Volunteers for Genetic and Clinical Studies

    PubMed Central

    Kelly, Susan E.; Spector, Timothy D.; Cherkas, Lynn F.; Prainsack, Barbara; Harris, Juliette M.

    2015-01-01

    Objectives To establish the views of research volunteers on the consent process; to explore their views on the consent process in different research scenarios; to inform debate on emerging models of consent for participation in research. Design, Setting and Participants 2,308 adult volunteers from the TwinsUK Registry (www.twinsuk.ac.uk) completed an online survey about their views on the consent process for use of their DNA and medical information in research. Their views on the re-consenting process in different scenarios were assessed. Results The majority of volunteers preferred to be informed of the identity of the main researcher of a study in which they are participating, which is contrary to current practice. Over 80% were willing to complete the consent process online instead of face to face. On the whole, respondents did not view their DNA differently from their medical information with regard to the consent process. Research participants were more willing to give broad consent to cover future research if their DNA was to be used by the original researcher than by another researcher, even if the disease under investigation varied, in contrast to the traditional ‘gold standard’ whereby specific consent is required for all new research projects. Discussion In some scenarios, research participants reported that they would be comfortable with not signing a new consent form for future research uses of their data and DNA, and are comfortable with secure, online consent processes rather than traditional face-to-face consent processes. Our findings indicate that the perceived relationship between research participants and researchers plays an important role in shaping preferences regarding the consent process and suggest that this relationship is not captured by traditional consent processes. We argue that the development of new formats of consent should be informed by empirical research on volunteers’ perceptions and preferences regarding the consent

  13. Clinical evaluation of carbon fiber reinforced carbon endodontic post, glass fiber reinforced post with cast post and core: A one year comparative clinical study

    PubMed Central

    Preethi, GA; Kala, M

    2008-01-01

    Aim: Restoring endodontically treated teeth is one of the major treatments provided by the dental practitioner. Selection and proper use of restorative materials continues to be a source of frustration for many clinicians. There is controversy surrounding the most suitable choice of restorative material and the placement method that will result in the highest probability of successful treatment. This clinical study compares two different varieties of fiber posts and one cast post and core in terms of mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology requiring crown removal over the period of 12months as evaluated by clinical and radiographical examination. Materials and Methods: 30 root canal treated, single rooted maxillary anterior teeth of 25 patients in the age range of 18–60 years where a post retained crown was indicated were selected for the study between January 2007 and August 2007; and prepared in a standard clinical manner. It was divided into 3 groups of 10 teeth in each group. After post space preparation, the Carbon fiber and Glass fiber reinforced posts were cemented with Scotch bond multipurpose plus bonding agent and RelyX adhesive resin cement in the first and second groups respectively. The Cast post and cores were cemented with Zinc Phosphate cement in the third group. Following post- cementation, the preparation was further refined and a rubber base impression was taken for metal-ceramic crowns which was cemented with Zinc Phosphate cement. A baseline periapical radiograph was taken once each crown was cemented. All patients were evaluated after one week (baseline), 3 months, 6 months and one year for following characteristics mobility of crown margin under finger pressure, recurrent caries detected at the crown margin, fracture of the restoration, fracture of the root and periapical and periodontal pathology

  14. Radiochemical studies, pre-clinical investigation and preliminary clinical evaluation of (170)Tm-EDTMP prepared using in-house freeze-dried EDTMP kit.

    PubMed

    Das, Tapas; Shinto, Ajit; Kamaleshwaran, Koramadai K; Sarma, Haladhar D; Mohammed, Sahiralam Khan; Mitra, Arpit; Lad, Sangita; Rajan, M G R; Banerjee, Sharmila

    2017-01-05

    The objective of the present work is to formulate (170)Tm-EDTMP using an in-house freeze-dried EDTMP kit and evaluate its potential as a bone pain palliation agent. Patient dose of (170)Tm-EDTMP was prepared with high radiochemical purity using the lyophilized kit at room temperature within 15min. Pre-clinical evaluation in normal Wistar rats revealed selective skeletal accumulation with extended retention. Preliminary clinical investigation in 8 patients with disseminated skeletal metastases exhibited selective uptake in the bone and retention therein for a long duration.

  15. Hyperacuity test to evaluate vision through dense cataracts: research preliminary to a clinical study in India

    NASA Astrophysics Data System (ADS)

    Enoch, Jay M.; Giraldez, Maria J.; Huang, Doahua; Hirose, Hiroshi; Knowles, Richard A.; Namperumalsamy, P.; LaBree, Lauri; Azen, Stanley P.

    1995-03-01

    Using high luminance point-of-light stimuli, Vernier judgments can be made in the presence of markedly degraded retinal imagery. Without coaching, observers perform center-of-gravity assessments of relative locations of degraded point images. We seek to defined, presurgery, individuals who will derive the most benefit from advanced cataract removal (a form of triage), and to determine which of two cataractous eyes has the better postsurgical visual prognosis. There are incredible and growing backlogs of patients with severe cataracts (and other dense media opacities) in the developing world, and generally, limited resources are available for provision of health care. Postcataract surgical failure rates for good visual function are often high, and only one eye is operated on in over 95% of indigent patients treated. Prior to initiating advanced studies in the developing world, at Berkeley we conducted preliminary research on Vernier acuity test techniques on normal adult subjects. We sought to determine the number of repeat trials necessary; to compare a two-point and a three-point Vernier display; to determine the shape of the measured response function at large gap separations between test points (required when testing advanced cataract patients); to assess the effect(s) of a broad range of uncorrected refractive errors on outcomes; and to consider means to minimize refraction-based errors. From these and prior data and analyses, we defined a protocol for use in the developing world. Using a newly designed and rugged precision instrument, these tests were repeated on an advanced cataract population at Aravind Eye Hospital in Madurai, India. Although we had much prior experience in India, the initial protocol required major revision on site. Necessary changes in test methods and analytical approaches were made, and next stages in this program were planned. And a new and simple gap `visual acuity' (gap `VA') test was added to the protocol, which greatly facilitated

  16. Evaluation of the efficacy of an hyaluronic acid-based biogel on periodontal clinical parameters. A randomized-controlled clinical pilot study

    PubMed Central

    Pilloni, Andrea; Annibali, Susanna; Dominici, Francesco; Di Paolo, Carlo; Papa, Marco; Cassini, Maria Antonietta; Polimeni, Antonella

    2012-01-01

    Summary Hyaluronic acid (HA) is an ubiquitous form of non-sulphated glycosaminoglycan of the extracellular matrix of all mammalian connective tissues. It is mainly present during tissue’s formation or during most of initial tissue’s repair processess. Cell migration, adhesion and differentiation are only part of several unique biological characteristics of HA which have been under investigation in the past decades. Aim of the study Evaluate the possible positive effect of an esterified form of HA on gingival tissues in mild chronic periodontitis patients, seeking for the reduction of all the periodontal disease clinical parameters PLI (Plaque Index), BOP (Bleeding on Probing), PPD (Probing Pocket Depth), GI (Gingival Index), PAL (Probing Attachment Level). Materials and methods The study is an open, intra-patient, controlled, single center pilot clinical trial including 19 adult patients with mild chronic periodontitis and shallow pockets (< 4 mm) in at least two different quadrants. One quadrant was treated with HA gel after regular toothbrushing (test), the other without (control). Results Although oral hygiene itself had a similar positive influence on the improvement of all the clinical indexes for test and control, the treatment with HA gel showed a greater effect almost always statistically significant. BOP in the HA gel treated areas had a decrease of 92.7% and GI of 96.5%, whereas controls 75.8% and 79.0% respectively. The difference of PPD in both areas was statistically significant (p<0.01) in favour of the HA gel treated zone. Also PAL and Pl were reduced more with gel than with oral hygiene alone, although this did not reach a statistical significant difference. Conclusion It appears that an esterified gel form of HA has shown an effect in reducing the gingival inflammation when used as an adjunct to mechanical home plaque control and that it could be successfully used to improve the periodontal clinical indexes. This pilot study will gain

  17. Large Controlled Observational Study on Remote Monitoring of Pacemakers and Implantable Cardiac Defibrillators: A Clinical, Economic, and Organizational Evaluation

    PubMed Central

    2016-01-01

    Background Patients with implantable devices such as pacemakers (PMs) and implantable cardiac defibrillators (ICDs) should be followed up every 3–12 months, which traditionally required in-clinic visits. Innovative devices allow data transmission and technical or medical alerts to be sent from the patient's home to the physician (remote monitoring). A number of studies have shown its effectiveness in timely detection and management of both clinical and technical events, and endorsed its adoption. Unfortunately, in daily practice, remote monitoring has been implemented in uncoordinated and rather fragmented ways, calling for a more strategic approach. Objective The objective of the study was to analyze the impact of remote monitoring for PM and ICD in a “real world” context compared with in-clinic follow-up. The evaluation focuses on how this service is carried out by Local Health Authorities, the impact on the cardiology unit and the health system, and organizational features promoting or hindering its effectiveness and efficiency. Methods A multi-center, multi-vendor, controlled, observational, prospective study was conducted to analyze the impact of remote monitoring implementation. A total of 2101 patients were enrolled in the study: 1871 patients were followed through remote monitoring of PM/ICD (I-group) and 230 through in-clinic visits (U-group). The follow-up period was 12 months. Results In-clinic device follow-ups and cardiac visits were significantly lower in the I-group compared with the U-group, respectively: PM, I-group = 0.43, U-group = 1.07, P<.001; ICD, I-group = 0.98, U-group = 2.14, P<.001. PM, I-group = 0.37, U-group = 0.85, P<.001; ICD, I-group = 1.58, U-group = 1.69, P=.01. Hospitalizations for any cause were significantly lower in the I-group for PM patients only (I-group = 0.37, U-group = 0.50, P=.005). There were no significant differences regarding use of the emergency department for both PM and ICD patients. In the I-group, 0.30 (PM

  18. Evaluation of a Single Dose Intravenous Paracetamol for Pain Relief After Maxillofacial Surgery: A Randomized Clinical Trial Study.

    PubMed

    Eftekharian, Hamidreza; Tabrizi, Reza; Kazemi, Hamidreza; Nili, Mahsa

    2014-12-01

    The aim of this study was to evaluate, using a single dose of intravenous paracetamol, pain relief after maxillofacial surgery. This is a controlled, randomized, uni- blind, clinical trial study to evaluate using a single dose of IV paracetamol for pain relief after maxillofacial surgery. The subjects were randomly divided into two groups with 40 subjects in each: group I received paracetamol (Apotel)* as a single dose and group II received placebo. Subjects were randomly allocated according to randomization lists. Paracetamol was used as a single dose (20 mg/kg in 100 cc of normal saline which was infused for 10 min after surgery in recovery room just before discharging). We used a visual analogue scale to investigate pain relief at various times. Analysis of the data, did not show any significant difference for age, sex and weight between the treatment group and the control group. Pain decreased 6 h after paracetamol infusion; then it increased mildly. In the control group, pain severity increased after operation, then it decreased mildly. Results showed a correlation between duration of surgery and pain severity in both the groups. Paracetamol is effective on pain relief after maxillofacial surgeries. Operation time may be an important factor for induction of pain after the surgeries.

  19. Evaluation of 3D-CRT, IMRT and VMAT radiotherapy plans for left breast cancer based on clinical dosimetric study.

    PubMed

    Liu, Haiyun; Chen, Xinde; He, Zhijian; Li, Jun

    2016-12-01

    This paper aims to compare dosimetric differences based on three types of radiotherapy plans for postoperative left breast cancer. In particular, based on a clinical dosimetric study, the three-dimensional conformal radiotherapy (3D-CRT), intensity- modulated radiation therapy (IMRT) and VMAT plans were implemented on 15 cases of postoperative patients with left breast cancer with prescription doses of 5000cGy. Dose volume histogram (DVH) was used to analyze each evaluation index of clinical target volume (CTV) and organs at risk (OARs). Except for homogeneous index (HI), D2, each CTV evaluation index of 3D-CRT plan was inferior to IMRT and VMAT plans (P<0.05). Compared with the VMAT plans, IMRT has a statistical significance only in Dmean, V95 (P<0.05). On the contrary, Dmean pertaining to the VMAT plan is much closer to the prescription dose with a V95 coverage rate as high as 97.44%. For the infected lung, V5, V10 of 3D-CRT were the lowest (P<0.05), while V20, V30 were the highest (P<0.05) among the three types of plans. Here, the V5, V10 of infected lung were slightly higher (P<0.05) for the VMAT and IMRT plans. Each evaluation index of the contralateral lung and heart in 3D-CRT was the lowest (P<0.05). D1 of contralateral breast was lower in both IMRT and VMAT plans, which were 1770.89±121.16cGy and 1839.92±92.77cGy, respectively. While D1 of the spinal cord in IMRT and VMAT plans was higher, which were 1990.12±61.52cGy and 1927.38±43.67cGy, respectively. When the radiation dose of 500-1500cGy was delivered to the normal tissues, 3D-CRT significantly shows the lowest volume, VMAT is relatively higher. Monitor Units (MU) and treatment time (T) of VMAT were the least, only 49.33% and 55.86% of those of IMRT. The three types of plans can meet the clinical dosimetry demands of postoperative radiotherapy for left breast cancer. The target of IMRT and VMAT plans has a better conformity, and the VMAT plan takes the advantages of less MU and treatment time

  20. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth gaps.

    PubMed

    Gahlert, Michael; Kniha, Heinz; Weingart, Dieter; Schild, Sabine; Gellrich, Nils-Claudius; Bormann, Kai-Hendrik

    2016-12-01

    Dental implants have traditionally been made from titanium or its alloys, but recently full-ceramic implants have been developed with comparable osseointegration properties and functional strength properties to titanium. These ceramic implants may have advantages in certain patients and situations, for example, where esthetic outcomes are particularly important. The objective of this investigation was to evaluate the performance of a newly developed full-ceramic ZrO2 monotype implant design (PURE Ceramic Implant; Institut Straumann AG, Basel, Switzerland) in single-tooth gaps in the maxilla and mandible. This was a prospective, open-label, single-arm study in patients requiring implant rehabilitation in single-tooth gaps. Full-ceramic implants were placed, with provisional and final prostheses inserted after 3 and 6 months, respectively. Crestal bone level was measured at implant placement and after 6 and 12 months. Implant survival and success were evaluated after 6 and 12 months. Further evaluations are planned after 24 and 36 months. Forty-six patients were screened for potential study participation, of whom 44 (17 men and 27 women, mean age 48 ± 14 years) were recruited into the study. The majority of implants (90.9%) were placed in the maxilla. The implant survival and implant success rate after 12 months were 97.6%. A minor change of the mean bone level occurred between implant loading (final prosthesis insertion after 6 months) and 12 months (-0.14 mm) after initial bone remodeling was observed between implant placement and loading (-0.88 mm). The results indicated that monotype ceramic implants can achieve clinical outcomes comparable to published outcomes of equivalent titanium implants. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  1. Comparative Evaluation of Commercially Available Freeze Dried Powdered Probiotics on Mutans Streptococci Count: A Randomized, Double Blind, Clinical Study

    PubMed Central

    Nagaraj, Anup; Ganta, Shravani; Sidiq, Mohsin; Pareek, Sonia; Vishnani, Preeti; Acharya, Siddharth; Singh, Kushpal

    2015-01-01

    Objectives: Probiotic approaches are being considered to eliminate pathogenic microorganisms and are an alternative and promising way to combat infections by using harmless bacteria to displace pathogenic microorganisms. The aim of this study was to evaluate the effectiveness of commercially available freeze dried powdered probiotics on mutans streptococci count among 12–15 year-old Indian schoolchildren. Materials and Methods: The study was conducted in two phases of in-vitro (phase I) and in-vivo (phase II) study, which was a double blind, randomized and placebo controlled clinical trial. A total of 33 schoolchildren between 12–15 years were included in the study. They were randomly allocated to three groups. Group A included 11 children using freeze dried Lactobacillus acidophilus, Bifidobacterium longum, Bifidobacterium bifidum and Bifidobacterium lactis. Group B included 11 children using freeze dried lactic acid bacillus only. Group C included 11 children using placebo powder. The study was conducted over a period of three weeks and examination and sampling of the subjects were done on days 0 (baseline), seven, 14 and 21. Results: For both the intervention groups A and B, statistically significant reduction (P<0.05) in salivary mutans streptococci counts was recorded up to the second week. Conclusion: Oral administration of probiotics showed a short-term effect on reduction of mutans streptococci count and showed a preventive role in caries development. PMID:27252756

  2. Building clinical networks: a developmental evaluation framework.

    PubMed

    Carswell, Peter; Manning, Benjamin; Long, Janet; Braithwaite, Jeffrey

    2014-05-01

    Clinical networks have been designed as a cross-organisational mechanism to plan and deliver health services. With recent concerns about the effectiveness of these structures, it is timely to consider an evidence-informed approach for how they can be developed and evaluated. To document an evaluation framework for clinical networks by drawing on the network evaluation literature and a 5-year study of clinical networks. We searched literature in three domains: network evaluation, factors that aid or inhibit network development, and on robust methods to measure network characteristics. This material was used to build a framework required for effective developmental evaluation. The framework's architecture identifies three stages of clinical network development; partner selection, network design and network management. Within each stage is evidence about factors that act as facilitators and barriers to network growth. These factors can be used to measure progress via appropriate methods and tools. The framework can provide for network growth and support informed decisions about progress. For the first time in one place a framework incorporating rigorous methods and tools can identify factors known to affect the development of clinical networks. The target user group is internal stakeholders who need to conduct developmental evaluation to inform key decisions along their network's developmental pathway.

  3. A study protocol for a randomised controlled trial evaluating clinical effects of platelet transfusion products: the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) trial

    PubMed Central

    Ypma, Paula F; van der Meer, Pieter F; Heddle, Nancy M; van Hilten, Joost A; Stijnen, Theo; Middelburg, Rutger A; Hervig, Tor; van der Bom, Johanna G; Brand, Anneke; Kerkhoffs, Jean-Louis H

    2016-01-01

    Introduction Patients with chemotherapy-induced thrombocytopaenia frequently experience minor and sometimes severe bleeding complications. Unrestrictive availability of safe and effective blood products is presumed by treating physicians as well as patients. Pathogen reduction technology potentially offers the opportunity to enhance safety by reducing bacterial and viral contamination of platelet products along with a potential reduction of alloimmunisation in patients receiving multiple platelet transfusions. Methods and analysis To test efficacy, a randomised, single-blinded, multicentre controlled trial was designed to evaluate clinical non-inferiority of pathogen-reduced platelet concentrates treated by the Mirasol system, compared with standard plasma-stored platelet concentrates using the percentage of patients with WHO grade ≥2 bleeding complications as the primary endpoint. The upper limit of the 95% CI of the non-inferiority margin was chosen to be a ≤12.5% increase in this percentage. Bleeding symptoms are actively monitored on a daily basis. The adjudication of the bleeding grade is performed by 3 adjudicators, blinded to the platelet product randomisation as well as by an automated computer algorithm. Interim analyses evaluating bleeding complications as well as serious adverse events are performed after each batch of 60 patients. The study started in 2010 and patients will be enrolled up to a maximum of 618 patients, depending on the results of consecutive interim analyses. A flexible stopping rule was designed allowing stopping for non-inferiority or futility. Besides analysing effects of pathogen reduction on clinical efficacy, the Pathogen Reduction Evaluation and Predictive Analytical Rating Score (PREPAReS) is designed to answer several other pending questions and translational issues related to bleeding and alloimmunisation, formulated as secondary and tertiary endpoints. Ethics and dissemination Ethics approval was obtained in all 3

  4. An Evaluation of Use of Botulinum Toxin Type A in the Management of Dynamic Forehead Wrinkles - A Clinical Study

    PubMed Central

    Susmita, Avvaru; Kolli, Naga Neelima Devi; Meka, Sridhar; Chakravarthi, Srinivas Pandi; Lingamaneni, Krishna Prasad; Shaik, Latheef Saheb

    2016-01-01

    Introduction The pursuit of youth and beauty has undergone a resurgence of interest which is evidenced by increasing cosmetic procedures. Botulinum Toxin Type A (Botox) is one among the many procedures invented for facial rejuvenation which denervates certain muscles of facial expression responsible for facial wrinkles. It has been applied in the forehead, glabella, lateral canthal area and neck. In maxillofacial area hyperactive forehead wrinkles show sagging. Aim This study was aimed to clinically evaluate the efficacy of Botox injection in the elimination of hyperdynamic forehead wrinkles and the objectives were to compare pre-operative and post-operative improvement in the number of wrinkles, photographic grading and patient satisfaction responses after 1st week, 4th week and 16th week. Materials and Methods A total of 10 patients were randomly included in the present study who were cooperative, motivated and aesthetically conscious with moderate to severe forehead wrinkles. Assessment was performed clinically, photographically (using standardized photographs) and patient satisfaction responses were recorded at 1st week, 4th week and 16th week. Results The study showed a significant difference in the elimination of wrinkles at rest and in action when assessed at 1st week and 4th week and it was consistent at 16th week. The patient showed positive satisfaction response without ptosis of the upper eyelid. Conclusion Treatment with Botox is simple, safe and an effective modality for reduction of forehead wrinkles. It offers an alternative management in a cost-effective way when compared to surgical procedures. PMID:27891474

  5. Improving clinical communication of students with English as a second language (ESL) using online technology: a small scale evaluation study.

    PubMed

    Rogan, Fran; San Miguel, Caroline

    2013-09-01

    Increasingly, students with English as a second language (ESL) are enrolled in nursing degrees in English speaking countries (Wang et al., 2008). However, they may be at risk of clinical practice failure due to communication difficulties associated with unfamiliar linguistic and cultural factors (Guhde, 2003). This paper describes and evaluates an innovation to assist ESL nursing students at an Australian university develop their clinical communication skills and practice readiness by providing online learning resources, using podcast and vodcast technology, that blend with classroom activities and facilitate flexible and independent learning. The innovation builds on an intensive clinical language workshop program called 'Clinically Speaking' which has evolved through a cyclical process of ongoing research to produce resources in response to students' learning needs. Whilst uptake of the resources was modest, students of ESL as well as English speaking backgrounds (ESB) found the resources improved their clinical preparation and confidence by increasing their understanding of expectations, clinical language and communication skills. The innovation, developed with a modest budget, shows potential in developing ESL and ESB students' readiness for clinical communication, enabling them to engage in clinical practice to develop competency standards required of nursing graduates and registration authorities.

  6. Using case study within a sequential explanatory design to evaluate the impact of specialist and advanced practice roles on clinical outcomes: the SCAPE study

    PubMed Central

    2013-01-01

    Background The role of the clinical nurse/midwife specialist and advanced nurse/midwife practitioner is complex not least because of the diversity in how the roles are operationalised across health settings and within multidisciplinary teams. This aim of this paper is to use The SCAPE Study: Specialist Clinical and Advanced Practitioner Evaluation in Ireland to illustrate how case study was used to strengthen a Sequential Explanatory Design. Methods In Phase 1, clinicians identified indicators of specialist and advanced practice which were then used to guide the instrumental case study design which formed the second phase of the larger study. Phase 2 used matched case studies to evaluate the effectiveness of specialist and advanced practitioners on clinical outcomes for service users. Data were collected through observation, documentary analysis, and interviews. Observations were made of 23 Clinical Specialists or Advanced Practitioners, and 23 matched clinicians in similar matched non-postholding sites, while they delivered care. Forty-one service users, 41 clinicians, and 23 Directors of Nursing or Midwifery were interviewed, and 279 service users completed a survey based on the components of CS and AP practice identified in Phase 1. A coding framework, and the generation of cross tabulation matrices in NVivo, was used to make explicit how the outcome measures were confirmed and validated from multiple sources. This strengthened the potential to examine single cases that seemed ‘different’, and allowed for cases to be redefined. Phase 3 involved interviews with policy-makers to set the findings in context. Results Case study is a powerful research strategy to use within sequential explanatory mixed method designs, and adds completeness to the exploration of complex issues in clinical practice. The design is flexible, allowing the use of multiple data collection methods from both qualitative and quantitative paradigms. Conclusions Multiple approaches to data

  7. Comparative field study evaluating the activity of recombinant factor VIII Fc fusion protein in plasma samples at clinical haemostasis laboratories

    PubMed Central

    Sommer, J M; Moore, N; McGuffie-Valentine, B; Bardan, S; Buyue, Y; Kamphaus, G D; Konkle, B A; Pierce, G F

    2014-01-01

    Discrepancies exist for some of the modified coagulation factors when assayed with different one-stage clotting and chromogenic substrate assay reagents. The aim of this study was to evaluate the performance of a recombinant factor VIII Fc fusion protein (rFVIIIFc), currently in clinical development for the treatment of severe haemophilia A, in a variety of one-stage clotting and chromogenic substrate assays in clinical haemostasis laboratories. Haemophilic plasma samples spiked with rFVIIIFc or Advate® at 0.05, 0.20 or 0.80 IU mL−1 were tested by 30 laboratories using their routine procedures and plasma standards. Data were evaluated for intra- and inter-laboratory variation, accuracy and possible rFVIIIFc-specific assay discrepancies. For the one-stage assay, mean recovery was 95% to 100% of expected for both Advate® and rFVIIIFc at 0.8 IU mL−1. Intra-laboratory percent coefficient of variance (CV) ranged from 6.3% to 7.8% for Advate®, and 6.0% to 10.3% for rFVIIIFc. Inter-laboratory CV ranged from 10% for Advate® and 16% for rFVIIIFc at 0.8 IU mL−1, to over 30% at 0.05 IU mL−1 for both products. For the chromogenic substrate assay, the average FVIII recovery was 107% ± 5% and 124% ± 8% of label potency across the three concentrations of Advate® and rFVIIIFc, respectively. Plasma rFVIIIFc levels can be monitored by either the one-stage or the chromogenic substrate assay routinely performed in clinical laboratories without the need for a product-specific rFVIIIFc laboratory standard. Accuracy by the one-stage assay was comparable to that of Advate®, while marginally higher results may be observed for rFVIIIFc when using the chromogenic assay. PMID:24261554

  8. Evaluating clinical librarian services: a systematic review.

    PubMed

    Brettle, Alison; Maden-Jenkins, Michelle; Anderson, Lucy; McNally, Rosalind; Pratchett, Tracey; Tancock, Jenny; Thornton, Debra; Webb, Anne

    2011-03-01

      Previous systematic reviews have indicated limited evidence and poor quality evaluations of clinical librarian (CL) services. Rigorous evaluations should demonstrate the value of CL services, but guidance is needed before this can be achieved.   To undertake a systematic review which examines models of CL services, quality, methods and perspectives of clinical librarian service evaluations.   Systematic review methodology and synthesis of evidence, undertaken collaboratively by a group of 8 librarians to develop research and critical appraisal skills.   There are four clear models of clinical library service provision. Clinical librarians are effective in saving health professionals time, providing relevant, useful information and high quality services. Clinical librarians have a positive effect on clinical decision making by contributing to better informed decisions, diagnosis and choice of drug or therapy. The quality of CL studies is improving, but more work is needed on reducing bias and providing evidence of specific impacts on patient care. The Critical Incident Technique as part of a mixed method approach appears to offer a useful approach to demonstrating impact.   This systematic review provides practical guidance regarding the evaluation of CL services. It also provides updated evidence regarding the effectiveness and impact of CL services. The approach used was successful in developing research and critical appraisal skills in a group of librarians. © 2010 The authors. Health Information and Libraries Journal © 2010 Health Libraries Group.

  9. Objective structured clinical evaluation as an assessment method for undergraduate chest physical therapy students: a cross-sectional study.

    PubMed

    Silva, Cibele C B M; Lunardi, Adriana C; Mendes, Felipe A R; Souza, Flavia F P; Carvalho, Celso R F

    2011-01-01

    The Objective Structured Clinical Evaluation (OSCE) has been considered a reliable method for the evaluation of students' clinical skills in health sciences, but it has been rarely applied in the teaching of physical therapy. To assess the use of the OSCE as a tool to evaluate the abilities of undergraduate chest physical therapy students and to verify the internal consistency of the OSCE exam. Forty-seven students were evaluated using two types of exams: the traditional exam and the OSCE. Independent educators elaborated the exams. Each question (traditional) or station (OSCE) was given a score ranging from 0.0 to 2.0; being 10.0 the highest possible score of both exams. The relationship between the total score that were obtained from both exams was analyzed using Bland-Altman analysis and Pearson's correlation coefficient. The internal consistency of the OSCE stations was evaluated by four experienced chest physical therapists and it was tested using Cronbach's alpha. The students' average score on the OSCE ranged from 4.4 to 9.6. The internal consistency of the OSCE stations was considered good (0.7). The agreement between exams was analyzed, and it was determined that the exams are not comparable. Examiners also observed a low agreement between the two exams (r=-0.1; p=0.9). Our results showed that OSCE and traditional exams are not interchangeable. The OSCE exam had good internal consistency and is able to evaluate aspects that the traditional exam fails to evaluate.

  10. A clinical study to evaluate and compare the masticatory performance in complete denture wearers with and without soft liners.

    PubMed

    Tata, Sreeharsha; Nandeeshwar, D B

    2012-11-01

    Soft liners are mainly used with complete dentures in case of poor mucosal conditions and for the even distribution of masticatory forces. However, there is some doubt as to whether the elasticity of the soft liner disturbs masticatory function because denture wearers may need extra force to compress the soft liners, leading to muscle fatigue. So, this clinical study was done to evaluate and compare the masticatory performance in patients wearing complete dentures with and without the use of soft liners. Twenty edentulous subjects were selected for the study. For each patient two sets of complete dentures were fabricated. First set without the use of soft liner and the second one for using with soft liner. Peanuts were selected as test food for the study and the chewed food was pooled for a single measurement and then poured on sieves. Both filter and filtrate were collected and was centrifuged. Masticatory performance in this study has been quantitated by dividing the volume of test food passing through the sieve by the total volume of test food recovered. The fraction is then expressed as a percent. With the paired t-test performed, significant difference was found between the masticatory performance in patients wearing complete dentures with and without the use of soft liners. 5% difference was seen in the mean performance. It has been concluded from this study that, masticatory performance in patients wearing complete dentures with the use of soft liners was improved by 5% when compared to the patients wearing complete dentures without using soft liners. This present study indicates that the masticatory performance enhanced with the use of soft liners for complete denture patients.

  11. Comparative evaluation of diode laser ablation and surgical stripping technique for gingival depigmentation: A clinical and immunohistochemical study

    PubMed Central

    Bakutra, Gaurav; Shankarapillai, Rajesh; Mathur, Lalit; Manohar, Balaji

    2017-01-01

    Introduction: There are various treatment modalities to remove the black patches of melanin pigmentation. The aim of the study is to clinically compare the diode laser ablation and surgical stripping technique for gingival depigmentation and to evaluate their effect on the histological changes in melanocyte activity. Materials and Methods: A total of 40 sites of 20 patients with bilateral melanin hyperpigmentation were treated with the surgical stripping and diode laser ablation technique. Change in Hedin index score, change in area of pigmentation using image analyzing software, pain perception, patient preference of treatment were recorded. All 40 sites were selected for immunohistochemical analysis using HMB-45 immunohistochemical marker. Results: At 12 months post-operative visit, in all sites, repigmentation was observed with different grades of Hedin index. Paired t-test, analysis of variance, and Chi-square tests were used for statistical analysis. Repigmentation in surgical stripping is significantly lesser compared to laser ablation. Lesser numbers of melanocytes were found on immunohistological examination at 12 months postoperatively. Comparison for patient preference and pain indices give statistically significant values for diode laser techniques. Conclusion: Gingival hyperpigmentation is effectively managed by diode laser ablation technique and surgical stripping method. In this study, surgical stripping technique found to be better compared to diode laser ablation. PMID:28539864

  12. Evaluation of endoscopic submucosal dissection using a new endosurgical knife DN-D2718B: a first clinical feasibility study.

    PubMed

    Sakaguchi, Yoshiki; Tsuji, Yosuke; Fujishiro, Mitsuhiro; Kataoka, Yosuke; Saito, Itaru; Shichijo, Satoki; Minatsuki, Chihiro; Asada-Hirayama, Itsuko; Yamaguchi, Daisuke; Niimi, Keiko; Ono, Satoshi; Kodashima, Shinya; Yamamichi, Nobutake; Koike, Kazuhiko

    2017-07-01

    Endosurgical devices with injection function have been reported to decrease endoscopic submucosal dissection (ESD) operation times for experts, but the efficacy of these devices for inexperienced endoscopists is unclear. The aim of this study was to evaluate the feasibility of ESD using a novel ESD knife (DN-D2718B). This is a single-center prospective pilot clinical feasibility study. Patients diagnosed with superficial gastrointestinal neoplasms were enrolled. A pre-specified group of ESD trainees with ESD experience on a porcine gastric model and fewer than 30 cases of ESD in their selected fields performed ESD under expert supervision, using the DN-D2718B. En bloc resection rates, R0 resection rates, procedure times, and incidence of intra-operational/post-operational adverse events were assessed. Between June 2015 and January 2016, 13 esophageal, 27 gastric, and 14 colorectal ESD cases were performed per-protocol with mean resection speeds of 10.2, 12.0, and 15.5 mm (2) /min, respectively. There were no intra-operational complications. ESD with this novel knife is feasible even when performed by non-experts.

  13. A new surgical strategy for treatment of tongue squamous cell carcinoma based on anatomic study with preliminary clinical evaluation.

    PubMed

    Ren, Zhen-Hu; Wu, Han-Jiang; Zhang, Sheng; Wang, Kai; Gong, Zhao-Jian; He, Zhi-Jing; Peng, Jie

    2015-10-01

    This study characterized the infiltration of primary tumors along the intrinsic and extrinsic muscles of the tongue in oral tongue squamous cell carcinoma (OTSCC), to create a new surgical strategy that is suitable for most stages. A preliminary evaluation of this novel surgical approach was also conducted. An anatomic study of macroscopic specimens from 10 human cadavers and 100 OTSCC patients was conducted. The anatomic characteristics of the primary tumors and the origin and distribution of fibers of the intrinsic and extrinsic tongue muscles were observed and measured. After initial treatment with curative intent, the 100 patients were regularly followed-up with clinical examination and imaging. Based on the anatomic characteristics of the primary tumors and tongue muscles, a new surgical approach was developed, and was described as muscle anatomy tongue surgery (MATS). MATS proved suitable for almost all stages of OTSCC. According to the morphology of the invasive tumor front, the 100 cases were divided into four types. The rate of 2-year local disease control was 98%, locoregional control 86%, disease-free survival 85%, and overall survival 89%. Tongue functions were perfectly recovered in more than 60% of the patients. Application of the principles of MATS to the treatment of OTSCC proved suitable for almost all stages of the disease. MATS is a novel surgical technique that may improve outcomes in tongue cancer surgery. Copyright © 2015 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  14. Comparative evaluation of diode laser ablation and surgical stripping technique for gingival depigmentation: A clinical and immunohistochemical study.

    PubMed

    Bakutra, Gaurav; Shankarapillai, Rajesh; Mathur, Lalit; Manohar, Balaji

    2017-01-01

    There are various treatment modalities to remove the black patches of melanin pigmentation. The aim of the study is to clinically compare the diode laser ablation and surgical stripping technique for gingival depigmentation and to evaluate their effect on the histological changes in melanocyte activity. A total of 40 sites of 20 patients with bilateral melanin hyperpigmentation were treated with the surgical stripping and diode laser ablation technique. Change in Hedin index score, change in area of pigmentation using image analyzing software, pain perception, patient preference of treatment were recorded. All 40 sites were selected for immunohistochemical analysis using HMB-45 immunohistochemical marker. At 12 months post-operative visit, in all sites, repigmentation was observed with different grades of Hedin index. Paired t-test, analysis of variance, and Chi-square tests were used for statistical analysis. Repigmentation in surgical stripping is significantly lesser compared to laser ablation. Lesser numbers of melanocytes were found on immunohistological examination at 12 months postoperatively. Comparison for patient preference and pain indices give statistically significant values for diode laser techniques. Gingival hyperpigmentation is effectively managed by diode laser ablation technique and surgical stripping method. In this study, surgical stripping technique found to be better compared to diode laser ablation.

  15. The CLUES study: a cluster randomized clinical trial for the evaluation of cardiovascular guideline implementation in primary care

    PubMed Central

    2013-01-01

    Background The appropriate care for people with cardiovascular risk factors can reduce morbidity and mortality. One strategy for improving the care for these patients involves the implementation of evidence-based guidelines. To date, little research concerning the impact of such implementation strategies in our setting has been published. Aims. To evaluate the effectiveness of a multifaceted tailored intervention in the implementation of three cardiovascular risk-related guidelines (hypertension, type 2 diabetes and dyslipidemia) in primary care in the Basque Health Service compared with usual implementation. Methods/Design A two-year cluster randomized clinical trial in primary care in two districts in the Basque Health Service. All primary care units are randomized. Data from all patients with diabetes, hypertension and those susceptible to coronary risk screening will be analyzed. Interventions. The control group will receive standard implementation. The experimental group will receive a multifaceted tailored implementation strategy, including a specific web page and workshops for family physicians and nurses. Endpoints. Primary endpoints: annual request for glycosylated hemoglobin, basic laboratory tests for hypertension, cardiovascular risk screening (women between 45–74 and men between 40–74 years old). Secondary endpoints: other process and clinical guideline indicators. Analysis: Data will be extracted from centralized computerized medical records. Analysis will be performed at a primary care unit level weighted by cluster size. Discussion The main contribution of our study is that it seeks to identify an effective strategy for cardiovascular guideline implementation in primary care in our setting. Trial registration Current Controlled Trials, ISRCTN88876909 PMID:24156549

  16. A sense of urgency: Evaluating the link between clinical trial development time and the accrual performance of cancer therapy evaluation program (NCI-CTEP) sponsored studies.

    PubMed

    Cheng, Steven K; Dietrich, Mary S; Dilts, David M

    2010-11-15

    Postactivation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, nonpediatric phase I, I/II, II, and III studies activated between 2000 and 2004 were investigated for an 8-year period (n = 419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios (OR), controlling for study phase and size of expected accruals. Among the CTEP-approved oncology trials, 37.9% (n = 221) failed to attain the minimum accrual goals, with 70.8% (n = 14) of phase III trials resulting in poor accrual. A total of 16,474 patients (42.5% of accruals) accrued to those studies were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months of development were significantly more likely to achieve accrual goals (OR, 2.15; 95% confidence interval, 1.29-3.57, P = 0.003) than trials with the median development times of 12 to 18 months. Trials requiring a development time of greater than 24 months were significantly less likely to achieve accrual goals (OR, 0.40; 95% confidence interval, 0.20-0.78; P = 0.011) than trials with the median development time. A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. ©2010 AACR.

  17. Clinical evaluation of incadronate in korean patients with malignancy-associated hypercalcemia: An open-label, multicenter study

    PubMed Central

    Kim, Sung-Bae; Lee, Jung Shin; Kim, Heung Tae; Im, Yong Hyuck; Kim, Tae Won; Ryoo, Baek Yeol; Park, Yeon Hee; Park, Joon Oh; Park, Keunchil; Katoh, Hitoshi; Yamamoto, Minoru

    2007-01-01

    Abstract Background: Incadronate has been found to lessen the increase in corrected serum calcium levels in malignancy-associated hypercalcemia (MAH) in a Phase III study in Japan. The drug is currently used to treat MAH in Japan. Objective: The purpose of this study was to assess the clinical usefulness of incadronate in patients with MAH. Methods: This open-label study was conducted at 3 medical institutions in Korea. Korean patients with MAH (corrected serum calcium levels ≥11.0 mg/dL) were given a single 10-mg IV infusion of incadronate over 2 to 4 hours in 500 to 1000 mL of normal saline. Corrected calcium levels were determined and subjective symptoms and objective findings (ie, bone pain, spontaneous pain, pain from contusion, tenderness, other pain, loss of appetite, nausea and/or vomiting, thirst, constipation, fatigue, and disturbance of consciousness) were used to monitor the effectiveness of the drug for 6 days after the infusion. Symptoms were evaluated using a 4-point scale (0 = none to 3 = severe). Adverse events (AEs) were identified by patients' reports, and adverse drug events (ADEs) were assessed by the investigators throughout the study. Results: Twenty-four Korean patients (18 [75%]male, 6 [25%]female; mean age, 56.5 years) were included in the study; data from 22 and 24 patients were used to assess effectiveness and tolerability, respectively. Corrected serum calcium level was significantly decreased on day 6 after treatment compared with pretreatment on day 0 (baseline) (9.51 [0.89] mg/dL vs 11.83 [0.89] mg/dL; P < 0.001). The antihypercalcemic effect of incadronate became apparent as an inhibition of bone absorption a few days after infusion. Corrected serum calcium level was significantly decreased on days 2 to 6 (P < 0.001) after treatment compared with pretreatment at baseline. Evaluation of symptoms showed significant improvement in the incadronate-treated group (mean total score [range] at baseline, 8 [1–23] and day 6, 5.5 [1–17

  18. Clinical evaluation of the Er,Cr:YSGG Laser therapy in the treatment of denture-related traumatic ulcerations: a randomized controlled clinical study.

    PubMed

    Kurtulmus-Yilmaz, Sevcan; Yilmaz, Hasan Guney; Tumer, Hayriye; Sadettinoglu, Koray

    2015-04-01

    The aim of this study was to evaluate the efficacy of Er,Cr:YSGG laser irradiation in reducing pain and on healing rate of traumatic ulcerations (TU) during a 2-week period after placement of new complete dentures. Denture-related TU are painful, and result in patient discomfort. Lasers are used in the treatment of different kinds of mucosal lesions; however, there are no published data available concerning the clinical outcome of the use of laser therapy in the treatment of TU. Thirty edentulous patients with newly fabricated complete dentures who subsequently developed one or more pairs of TU participated in this study. For each patient, ulcerations were randomly assigned to the test and control groups. In the test group, ulcerations were irradiated with Er,Cr:YSGG laser. In the control group, the same laser without laser emission was used. Pain was assessed with a visual analog scale (VAS). Healing of ulcerations (HU) was graded by a clinician. In the test group, laser irradiation provided significantly reduced pain immediately after treatment, and provided a significant healing effect 1 day after treatment, and these effects were maintained throughout the study. In the control group, baseline VAS scores were not statistically significant at baseline and 1 day after treatment, and HU scores were statistically significant 3, 7, and 14 days after treatment. Intergroup comparisons revealed that the differences in VAS and HU scores were statistically significant for all time periods after treatment, except for day 14. Based on these findings, it may be concluded that Er,Cr:YSGG laser is effective in the treatment of TU.

  19. Evaluating the performance of clinical dietitians.

    PubMed

    Gates, G E; Holdt, C S

    1993-05-01

    The purposes of this study were to describe how clinical managers evaluate the performance of clinical dietitians and to examine managers' opinions about performance appraisal. Managers from 55 acute-care hospitals in seven midwestern states responded to a telephone survey about their appraisal of the performance of clinical dietitians. Most of the clinical managers had developed criteria with written standards for evaluating performance. Respondents evaluated the dietitians once a year and relied primarily on chart audits, other work samples, and critical incidents to judge performance. Managers in 32 of the hospitals asked their subordinates to complete a self-appraisal, and almost all of the managers negotiated with the dietitians to identify goals for professional improvement. Respondents' reasons for conducting performance appraisals were indicative of a participative management style. During the interviews, many clinical managers requested help in improving their performance appraisal systems, which suggests a need for additional training in conducting performance appraisals. The findings indicate that most clinical managers were following recommended guidelines for conducting performance appraisals.

  20. Performance Characteristics of MR Imaging in the Evaluation of Clinically Low-Risk Prostate Cancer: A Prospective Study

    PubMed Central

    Vargas, Hebert Alberto; Akin, Oguz; Shukla-Dave, Amita; Zhang, Jingbo; Zakian, Kristen L.; Zheng, Junting; Kanao, Kent; Goldman, Debra A.; Moskowitz, Chaya S.; Reuter, Victor E.; Eastham, James A.; Scardino, Peter T.

    2012-01-01

    Purpose: To prospectively evaluate diagnostic performance of T2-weighted magnetic resonance (MR) imaging and MR spectroscopic imaging in detecting lesions stratified by pathologic volume and Gleason score in men with clinically determined low-risk prostate cancer. Materials and Methods: The institutional review board approved this prospective, HIPAA-compliant study. Written informed consent was obtained from 183 men with clinically low-risk prostate cancer (cT1–cT2a, Gleason score ≤ 6 at biopsy, prostate-specific antigen [PSA] level < 10 ng/mL [10 μg/L]) undergoing MR imaging before prostatectomy. By using a scale of 1–5 (score 1, definitely no tumor; score 5, definitely tumor), two radiologists independently scored likelihood of tumor per sextant on T2-weighted images. Two spectroscopists jointly recorded locations of lesions with metabolic features consistent with tumor on MR spectroscopic images. Whole-mount step-section histopathologic analysis constituted the reference standard. Diagnostic performance at sextant level (T2-weighted imaging) and detection sensitivities (T2-weighted imaging and MR spectroscopic imaging) for lesions of 0.5 cm3 or larger were calculated. Results: For T2-weighted imaging, areas under the receiver operating characteristic curves for sextant-level detection were 0.77 (reader 1) and 0.82 (reader 2). For lesions of ≥0.5 cm3 and ,1 clinically low-risk prostate

  1. [Possibilities for the improvement of the quality of knowledge and their evaluation in the course of studying clinical medicine].

    PubMed

    Tetenev, F F; Bodrova, T N; Ageeva, T S; Karzilov, A I; Kalinina, O V

    2014-01-01

    The authors consider objective and subjective factors exerting negative influence on the quality of knowledge of physicians. The generally accepted methods for its evaluation (testing and rating-systems) have limitations. Testing reflects the level of knowledge with respect to the mode of thinking of its designer while rating mostly characterizes diligence of the trainee. It is proposed to improve the quality of knowledge by teaching the theory of diagnostics and to evaluate the amount of knowledge from the contents of the descriptive part of the medical history. The quality of knowledge can be assessed based on the contents of professional comments on the clinical picture described in the model case history.

  2. Evaluation of Vertical Bone Gain Following Alveolar Distraction Osteogenesis in the Anterior Edentulous Mandible: A Clinical Study.

    PubMed

    Kumar, K A Jeevan; Masrom, Aruna Kishore; Patil, Kapil; Kunusoth, Ramesh; Begum, Farzana; Venkatesh, Veerareddy

    2014-12-01

    To calculate the gain in bony height and volume of the distracted upper segment using an extraosseous unidirectional device to improve the retention of the future prosthesis. Ten cases with completely or partially edentulous but severely or considerably resorbed anterior mandibles were managed by vertical alveolar distraction osteogenesis. All the patients were evaluated preoperatively, intraoperatively and post-operatively for various parameters clinically and radiographically i.e. on OPG, lateral cephalogram and on CT scan, at different time intervals. In all cases there was increase in vertical bone height. The study showed mean vertical bone gain (VBG) on OPG as 8.2 mm. The mean VBG on lateral cephalogram was 8.1 mm. The mean VBG on CT scan at right canine was 8.35 mm, at left canine was 8.2 mm and at midline was 8.27 mm. Alveolar distraction osteogenesis is a predictable method for restoring alveolar ridges prior to implant placement or prosthesis. Distraction osteogenesis is ideally suited for recreating missing tissue in the anterior esthetic zone by increasing vertical bone height as well as good width and soft tissue growth.

  3. Clinical Evaluation of Ebola Virus Disease Therapeutics.

    PubMed

    Liu, Guodong; Wong, Gary; Su, Shuo; Bi, Yuhai; Plummer, Frank; Gao, George F; Kobinger, Gary; Qiu, Xiangguo

    2017-09-01

    Ebola virus disease (EVD) was first described over 40 years ago, but no treatment has been approved for humans. The 2013-2016 EVD outbreak in West Africa has expedited the clinical evaluation of several candidate therapeutics that act through different mechanisms, but with mixed results. Nevertheless, these studies are important because the accumulation of clinical data and valuable experience in conducting efficacy trials under emergency circumstances will lead to better implementation of similar studies in the future. Here, we summarize the results of EVD clinical trials, focus on the discussion of factors that may have potentially impeded the effectiveness of existing candidate therapeutics, and highlight considerations that may help meet the challenges ahead in the quest to develop clinically approved drugs. Copyright © 2017 Elsevier Ltd. All rights reserved.

  4. Implementation of post treatment critical evaluation improved the quality of orthodontic care in postgraduate orthodontic clinic: A 10 years comparative study

    PubMed Central

    Verma, Rashmi; Utreja, Ashok Kumar; Singh, Satinder Pal; Jena, Ashok Kumar

    2015-01-01

    Objective: The aim of the study was to evaluate the effect of post- treatment critical evaluation on the quality of orthodontic care in a postgraduate orthodontic clinic. Materials and Methods: Orthodontic treatment outcome of 109 consecutively treated cases was evaluated in Phase-I evaluation. Following Phase-I evaluation, PTCE of each case was made mandatory. After 6-years of implementation of compulsory PTCE for each case, orthodontic treatment outcome of all consecutively treated cases (n = 126) was evaluated (Phase-II). The treatment outcome was evaluated by American Board of Orthodontics Model Grading System (ABO MGS) and Subjective evaluation (Visual Analogue Scale, VAS). Results: Based on the ABO scores, the cases were divided into three grades, that is, Grade-I, Grade-II, and Grade-III. The mean total ABO score was improved significantly in Phase-II evaluation (P < 0.01). The total number of cases in ABO Grade-II were increased significantly (P < 0.01) whereas cases in ABO Grade-I remained comparable. The VAS score was improved from 5.66 ± 0.77 at Phase-I to 6.02 ± 0.99 at Phase-II evaluation (P < 0.01). Conclusion: The implementation of PTCE significantly improved the quality of orthodontic care in a postgraduate orthodontic clinic. Clinical Significance: Grading one's own treatment improves the quality of future treatment. PMID:26392728

  5. [Clinical evaluation of living donor].

    PubMed

    Scolari, Maria Piera; Comai, G; La Manna, G; Liviano D'Arcangelo, G; Monti, M; Feliciangeli, G; Stefoni, S

    2009-01-01

    When possible, living donor transplantation represents the best therapeutic strategy for patients suffering from chronic renal failure. Studying the donor allows a complete and thorough clinical, laboratory and instrumental assessment that guarantees good organ function whilst protecting the health of the donor. The main parameters considered within this framework are age, renal function, nephrological complications, comorbidities (diabetes, hypertension, obesity, etc.), malignancies, and infection. Moreover, particular attention is paid to the sociopsychological aspects of the donation, particularly related to the donor, the recipient, and the entire family situation.

  6. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    PubMed

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  7. Certainty rating in pre-and post-tests of study modules in an online clinical pharmacy course - A pilot study to evaluate teaching and learning.

    PubMed

    Luetsch, Karen; Burrows, Judith

    2016-10-14

    Graduate and post-graduate education for health professionals is increasingly delivered in an e-learning environment, where automated, continuous formative testing with integrated feedback can guide students' self-assessment and learning. Asking students to rate the certainty they assign to the correctness of their answers to test questions can potentially provide deeper insights into the success of teaching, with test results informing course designers whether learning outcomes have been achieved. It may also have implications for decision making in clinical practice. A study of pre-and post-tests for five study modules was designed to evaluate the teaching and learning within a pharmacotherapeutic course in an online postgraduate clinical pharmacy program. Certainty based marking of multiple choice questions (MCQ) was adapted for formative pre- and post-study module testing by asking students to rate their certainty of correctness of MCQ answers. Paired t-tests and a coding scheme were used to analyse changes in answers and certainty between pre-and post-tests. A survey evaluated students' experience with the novel formative testing design. Twenty-nine pharmacists enrolled in the postgraduate program participated in the study. Overall 1315 matched pairs of MCQ answers and certainty ratings between pre- and post-module tests were available for evaluation. Most students identified correct answers in post-tests and increased their certainty compared to pre-tests. Evaluation of certainty ratings in addition to correctness of answers identified MCQs and topic areas for revision to course designers. A survey of students showed that assigning certainty ratings to their answers assisted in structuring and focusing their learning throughout online study modules, facilitating identification of areas of uncertainty and gaps in their clinical knowledge. Adding certainty ratings to MCQ answers seems to engage students with formative testing and feedback and focus their

  8. Evaluation of dynamic infrared thermography as an alternative to CT angiography for perforator mapping in breast reconstruction: a clinical study.

    PubMed

    Weum, Sven; Mercer, James B; de Weerd, Louis

    2016-07-15

    The current gold standard for preoperative perforator mapping in breast reconstruction with a DIEP flap is CT angiography (CTA). Dynamic infrared thermography (DIRT) is an imaging method that does not require ionizing radiation or contrast injection. We evaluated if DIRT could be an alternative to CTA in perforator mapping. Twenty-five patients scheduled for secondary breast reconstruction with a DIEP flap were included. Preoperatively, the lower abdomen was examined with hand-held Doppler, DIRT and CTA. Arterial Doppler sound locations were marked on the skin. DIRT examination involved rewarming of the abdominal skin after a mild cold challenge. The locations of hot spots on DIRT were compared with the arterial Doppler sound locations. The rate and pattern of rewarming of the hot spots were analyzed. Multiplanar CT reconstructions were used to see if hot spots were related to perforators on CTA. All flaps were based on the perforator selected with DIRT and the surgical outcome was analyzed. First appearing hot spots were always associated with arterial Doppler sounds and clearly visible perforators on CTA. The hot spots on DIRT images were always slightly laterally located in relation to the exit points of the associated perforators through the rectus abdominis fascia on CTA. Some periumbilical perforators were not associated with hot spots and showed communication with the superficial inferior epigastric vein on CTA. The selected perforators adequately perfused all flaps. This study confirms that perforators selected with DIRT have arterial Doppler sound, are clearly visible on CTA and provide adequate perfusion for DIEP breast reconstruction. Retrospectively registered at ClinicalTrials.gov with identifier NCT02806518 .

  9. Mathematical evaluation of the influence of multiple factors on implant stability quotient values in clinical practice: a retrospective study

    PubMed Central

    Huang, Hairong; Wismeijer, Daniel; Shao, Xianhong; Wu, Gang

    2016-01-01

    Objectives The objective of this study is to mathematically evaluate the influence of multiple factors on implant stability quotient values in clinical practice. Patients and methods Resonance frequency analysis was performed at T1 (measured immediately at the time of implant placement) and at T2 (measured before dental restoration) in 177 patients (329 implants). Using a multivariate linear regression model, we analyzed the influence of the following eleven candidate factors: sex, age, maxillary/mandibular location, bone type, immediate/delayed implantation, bone grafting (presence or absence), insertion torque, I-/II-stage healing pattern, implant diameter, implant length, and T1–T2 time interval. Results The following factors were identified to significantly influence the implant stability quotient (ISQ) values at T1: insertion torque, bone grafting, I-/II-stage healing pattern, immediate/delayed implantation, maxillary/mandibular location, implant diameter, and sex. In contrast, the ISQ values at T2 were significantly influenced only by three factors: implant diameter, T1–T2 time interval, and insertion torque. Conclusion Among the eleven candidate factors, seven key factors were found to influence the T1-ISQ values, while only three key factors influenced the T2-ISQ values. Both T1 and T2-ISQ values were found to be influenced by implant diameter and insertion torque. T1 was influenced specifically by the sex of the patient, the location (maxillary or mandibular), the implantation mode (immediate/delayed implantation), the healing stage, and the absence or presence of bone graft materials. PMID:27785040

  10. A comparative evaluation of static and functional methods for recording centric relation and condylar guidance: a clinical study.

    PubMed

    Thakur, Mridul; Jain, Veena; Parkash, Hari; Kumar, Pravesh

    2012-09-01

    To evaluate and compare the centric relation and horizontal condylar guidance using interocclusal wax and extra oral Gothic arch methods and subjective evaluation of dentures thus fabricated. Centric relation and horizontal condylar guidance was recorded by using interocclusal wax and gothic arch tracing in 28 completely edentulous patients. These records were transferred to the articulator and difference in both values was recorded. After that patients were divided in two groups according to the centric relation and horizontal condylar guidance recording method used to achieve balanced occlusion. Response of the dentures was subjectively evaluated using "Woelfel subjective evaluation criteria". Centric relation recorded by both the methods did coincide in 7.14 % of patients. Centric relation recorded by interocclusal wax was posterior to Gothic centric relation in 21.43 % of patients, and anterior to Gothic centric relation in 71.42 % patients. Gothic arch tracings gave higher mean guidance values on both the sides as compared to protrusive wax record in all the subjects, although the difference was statistically insignificant (P > 0.05). Subjective evaluation showed statistical insignificance for all the parameters in both groups. Gothic arch method records the centric relation at a more posterior position than the Static method, but it does not make any difference in clinical performance of the complete denture. Horizontal condylar guidance angle was approximately similar by both the methods.

  11. Evaluation of spasticity after stroke by using ultrasound to measure the muscle architecture parameters: a clinical study

    PubMed Central

    Yang, Yuan-Bin; Zhang, Jing; Leng, Zhen-Peng; Chen, Xin; Song, Wei-Qun

    2014-01-01

    Objective: This study aims to compare the difference and the change trend of Muscle Architecture Parameters (MAP) between spastic and normal muscle tone patients after stroke, and analysis the application and value of Muscle Architecture Parameters in evaluating spasticity after stroke. Methods: 41 stroke patients were divided into spastic group (26 cases), normal muscle tone control group (15 cases). Modified Ashworth Scale (MAS) was applied in both groups for assessing muscle tone of lower limbs (no influence, contralateral). Muscle architectural parameters of ultrasound measurement include muscle thickness, fascicle length and pennation angle. The difference of three muscle architectural parameters between the affected side and the contralateral side in spastic group and the difference of MAS and three muscle architectural parameters between spastic group and normal control group were compared. Results: MAS score, Pennation Angle (PA) and Muscular Thickness (MT) value of MAP in spastic group were significantly higher than the control group, Fascicle length (FL) is significantly lower than the control group (P < 0.05). In spastic group, MAS score, PA and MT value of MAP of affected side muscle was substantially higher than that of contralateral, FL value significantly lower than that of contralateral (P < 0.05). There was positive correlation between MAS and PA and MT but was negative correlation between MAS and FL, rank correlation coefficient test was statistical significant (p < 0.05). Logistic multivariate regression analysis showed that spasticity can lead PA and FL to change (p < 0.05), there is no clear correlation between MT and spasticity occurs (P > 0.05). Conclusion: MAP has a better sensitivity in evaluating muscle tone between spastic patients and non-spastic patients, and degrees of spasticity have a clear corresponding exponential relationship to MAP. Combing MAS and MAP can assess muscle tone more objectively and accurately because subtle changes

  12. Integrated care for asthma: a clinical, social, and economic evaluation. Grampian Asthma Study of Integrated Care (GRASSIC)

    PubMed Central

    1994-01-01

    OBJECTIVES--To evaluate integrated care for asthma in clinical, social, and economic terms. DESIGN--Pragmatic randomised trial. SETTING--Hospital outpatient clinics and general practices throughout the north east of Scotland. PATIENTS--712 adults attending hospital outpatient clinics with a diagnosis of asthma confirmed by a chest physician and pulmonary function reversibility of at least 20%. MAIN OUTCOME MEASURES--Use of bronchodilators and inhaled and oral steroids; number of general practice consultations and hospital admissions for asthma; sleep disturbance and other restrictions on normal activity; psychological aspects of health including perceived asthma control; patient satisfaction; and financial costs. RESULTS--After one year there were no significant overall differences between those patients receiving integrated asthma care and those receiving conventional outpatient care for any clinical or psychosocial outcome. For pulmonary function, forced expiratory volume was 76% of predicted for integrated care patients and 75% for conventional outpatients (95% confidence interval for difference -3.6% to 5.0%). Patients who had experienced integrated care were more likely to select it as their preferred course of future management (75% (251/333) v 62% (207/333) (6% to 20%)); they saved 39.52 pounds a year. This was largely because patients in conventional outpatient care consulted their general practitioner as many times as those in integrated care, who were not also visiting hospital. CONCLUSION--Integrated care for moderately severe asthma patients is clinically as effective as conventional outpatient care, cost effective, and an attractive management option for patients, general practitioners, and hospital consultants. PMID:8148678

  13. Clinico-pathological study to evaluate oral lichen planus for the establishment of clinical and histopathological diagnostic criteria.

    PubMed

    Hiremath, Santhosh; Kale, Alka D; Hallikerimath, Seema

    2015-01-01

    Lichen planus and lichenoid lesions affecting the oral cavity show similar clinico-pathological features creating a diagnostic dilemma. Hence, the aim of the present study was to establish a clinical and histopathological correlation in the diagnosis of oral lichen planus, based on the modified WHO diagnostic criteria of oral lichen planus and oral lichenoid lesions proposed by Van der Meij and Van der Waal in 2003. In the present study, 100 cases of oral lichen planus were clinically and histopathologically analyzed. Out of the 100 cases, 50 were prospective and 50 were retrospective cases. Prospective cases were collected based on the clinical diagnosis of oral lichen planus and oral lichenoid lesion. Retrospective cases were collected based on the histopathological diagnosis of oral lichen planus. Both the clinical and histopathological analyses were performed based on a proposal for a set of modified diagnostic criteria of oral lichen planus and oral lichenoid lesion. A final diagnosis of oral lichen planus was made only after the correlation of the clinical diagnosis with the histopathological diagnosis. The interobserver agreement among three observers for both prospective and retrospective cases in the final diagnosis of oral lichen planus was found to be "good" to "very good" indicating high reproducibility. However, the final diagnoses of true oral lichen planus after clinico-pathological correlation in prospective and retrospective study groups appeared to be 38.0% and 54.0% respectively. The results of the present study revealed mild to moderate clinico-pathological correlation in the final diagnosis of oral lichen planus for the prospective and retrospective study groups respectively.

  14. Clinical evaluation of giomer- and resin-modified glass ionomer cement in class V noncarious cervical lesions: An in vivo study.

    PubMed

    Jyothi, Kn; Annapurna, S; Kumar, Anil S; Venugopal, P; Jayashankara, Cm

    2011-10-01

    To evaluate and compare the clinical performance of Giomer (Beautifil II) and RMGIC (Fuji II LC) in noncarious cervical lesions. Thirty-two subjects with one or two pairs of noncarious cervical lesions were included in the study. Each pair of lesion was restored with either giomer or RMGIC assigned randomly. Clinical evaluation of restorations was done using USPHS criteria. Data was formulated in a predesigned format and subjected to statistical analysis using the chi square test. Statistically significant difference was found between RMGIC and Giomer with respect to surface roughness with P value <0.001. Giomer showed superior surface finish compared to RMGIC. Both Giomer and RMGIC showed equal retention ability.

  15. Evaluating the quality of informed consent and contemporary clinical practices by medical doctors in South Africa: An empirical study

    PubMed Central

    2013-01-01

    Background Informed consent is a legal and ethical doctrine derived from the principle of respect for autonomy. Generally two rights derived from autonomy are accorded legal protection. The constitutional right to bodily integrity followed by the right to bodily well-being, protected by professional negligence rules. Therefore healthcare professionals treating patients' without valid consent may be guilty of infringing patients' rights. Many challenges are experienced by doctors obtaining informed consent in complex multicultural societies like South Africa. These include different cultural ethos, multilingualism, poverty, education, unfamiliarity with libertarian rights based autonomy, and power asymmetry between doctors and patients. All of which could impact on the ability of doctors to obtain legally valid informed consent. Methods The objective of this study was to evaluate whether the quality of informed consent obtained by doctors practicing in South Africa is consistent with international ethical standards and local regulations. Responses from 946 participants including doctors, nurses and patients was analyzed, using a semi-structured self-administered questionnaire and person triangulation in selected public hospitals in Durban, KwaZulu-Natal, South Africa. Results The median age of 168 doctors participating was 30 years with 51% females, 28% interns, 16% medical officers, 26% registrars, 30% consultant/specialists. A broad range of clinical specialties were represented. Challenges to informed consent practice include language difficulties, lack of interpreters, workload, and time constraints. Doctors spent 5-10 minutes on consent, disclosed most information required to patients, however knowledge of essential local laws was inadequate. Informed consent aggregate scores (ICAS) showed that interns/registrars scored lower than consultants/specialists. ICAS scores were statistically significant by specialty (p = 0.005), with radiologists and anaesthetists

  16. Clinical and radiographic evaluation of indirect pulp treatment with MTA and calcium hydroxide in primary teeth (in-vivo study).

    PubMed

    George, Vimi; Janardhanan, Suresh Kumar; Varma, Balagopal; Kumaran, Parvathy; Xavier, Arun Mamachan

    2015-01-01

    Clinical and radiographic effects of mineral trioxide aggregate (white MTA) and calcium hydroxide (Dycal) in indirect pulp treatment (IPT) of primary teeth over a period of 6 months. A clinical trial with sample size of 40 primary molars between the age group of 5-9 years, of which, 20 teeth were considered, each for MTA and Dycal. Measurements on the digitized radiographs were performed at baseline, third and sixth month, increase in dentin was then measured using Corel Draw software. Independent t-test had indicated that at the end of 3 months and 6 months, a statistically significant increase in dentin thickness with both MTA and Dycal (P-value ≤ 0.001) was found. Within the MTA group, the thickness of dentin formed was 0.089 mm ± 0.031 mm at first 3 months and 0.055 ± 0.022 mm at the second 3 months, (P ≤ 0.001) evaluated using paired t-test. In the Dycal group, increment in dentin deposited was 0.068 mm at the first 3 months and second 3 months, it was 0.030 mm (P-value ≤ 0.001). Clinically and radiographically, MTA is superior to Dycal as a good IPT medicament in primary teeth.

  17. Clinical evaluation of toric soft lens reproducibility.

    PubMed

    Young, Graeme; Coleman, Sarah; Hickson-Curran, Sheila

    2002-05-01

    The manufacturing variability of frequent replacement toric soft lenses is such that some resulting variation in clinical performance can be expected. The purpose of this study was to evaluate the effect of manufacturing variability on the clinical performance of three frequent replacement toric soft contact lenses. This was a three-part study in which 12 to 14 subjects were enrolled for each part. In each part, subjects were preadapted to the lens type 1 month prior to the assessment visits. Subjects wore a total of 12 test lenses in one eye and, in each case, the clinical performance was compared with a control lens of the same type worn in the other eye that was removed between assessments but not replaced. The study lenses were Acuvue Toric (Vistakon), Focus Toric (Ciba Vision) and FreshLook Toric (Wesley lessen). Two lens types (Focus Toric and FreshLook Toric) showed significantly greater variability with the test lenses compared with the nonreplaced control lenses with several variables: lens fit, visual acuity, and subjective vision quality. One lens (Focus Toric) also showed greater variability of orientation position, and another (Acuvue Toric) showed greater variability in subjective vision quality. The study demonstrated variability in aspects of clinical performance, which appear to be linked to variability of manufacturing output. With toric soft lenses used on a frequent replacement basis, better reproducibility is needed if consistent clinical performance is to be maintained.

  18. PROMIS — Prostate MR imaging study: A paired validating cohort study evaluating the role of multi-parametric MRI in men with clinical suspicion of prostate cancer☆

    PubMed Central

    El-Shater Bosaily, A.; Parker, C.; Brown, L.C.; Gabe, R.; Hindley, R.G.; Kaplan, R.; Emberton, M.; Ahmed, H.U.

    2015-01-01

    Background Transrectal ultrasound-guided prostate biopsies are prone to detection errors. Multi-parametric MRI (MP-MRI) may improve the diagnostic pathway. Methods PROMIS is a prospective validating paired-cohort study that meets criteria for level 1 evidence in diagnostic test evaluation. PROMIS will investigate whether multi-parametric (MP)-MRI can discriminate between men with and without clinically-significant prostate cancer who are at risk prior to first biopsy. Up to 714 men will have MP-MRI (index), 10–12 core TRUS-biopsy (standard) and 5 mm transperineal template mapping (TPM) biopsies (reference). The conduct and reporting of each test will be blinded to the others. Results PROMIS will measure and compare sensitivity, specificity, and positive and negative predictive values of both MP-MRI and TRUS-biopsy against TPM biopsies. The MP-MRI results will be used to determine the proportion of men who could safely avoid biopsy without compromising detection of clinically-significant cancers. For the primary outcome, significant cancer on TPM is defined as Gleason grade >/= 4 + 3 and/or maximum cancer core length of ≥ 6 mm. PROMIS will also assess inter-observer variability among radiologists among other secondary outcomes. Cost-effectiveness of MP-MRI prior to biopsy will also be evaluated. Conclusions PROMIS will determine whether MP-MRI of the prostate prior to first biopsy improves the detection accuracy of clinically-significant cancer. PMID:25749312

  19. Evaluating student performance in clinical dietetics.

    PubMed

    Novascone, M A

    1985-06-01

    The focus of this study was on the development and field-testing of a set of behaviorally anchored rating scales for evaluating the clinical performance of dietetic students. The scales emphasized the application of skills and knowledge. A variation of the Smith-Kendall technique was used to develop the scales. The 42 participants involved in instrument development included dietetic students, didactic and clinical instructors, and dietetic practitioners. The completed instrument contained 8 dimension statements and 70 behavioral anchors. The instrument was field-tested in 16 clinical rotations within 8 dietetic education programs. Evaluators not only rated student performance but also critiqued the format and content of the scales. The mid-to-upper portions of each scale were used most frequently, and little score variation within or across programs was noted. The scales were deemed appropriate for formative evaluation; however, some evaluators who had to grade students' performance expressed a desire for performance standards defined in terms of grades. Because the process used to develop the instrument facilitated the articulation of performance criteria, it is recommended as a practical approach to setting performance standards.

  20. The clinical information system implementation evaluation scale.

    PubMed

    Gugerty, Brian; Maranda, Michael; Rook, Dona

    2006-01-01

    Measurement instruments to assess user satisfaction with Clinical Information Systems (CIS) and with the implementation of CIS are needed as part of multi-faceted evaluation of CIS. Seven years of experience in developing measurement instruments to assess staff satisfaction with CIS preceded the development effort that created the Clinical Information System Evaluation Scale (CISIES). The scale was developed using precursors of the CISIES and it was guided by an expert panel. Following its construction the 37-item measurement instrument was piloted as part of the assessment of a Critical Care Clinical Information System implementation at a medical center in Florida, USA. Results indicated satisfaction with the implementation, although not strong, at the time of administration. The results of the CISIES administration were used by informaticians at the research site to plan and execute an intervention to improve satisfaction with the implementation. Re-administration of the CISIES at the site to evaluate the success of this intervention is planned. The CISIES was found to be a useful instrument, easy to administer, acceptable to respondents, easy to score and understandable by non-researcher at the study site. Early indications are that it will be useful in the formative and summative evaluation of CIS implementations.

  1. Evaluating Clinical Teaching in Medicine.

    ERIC Educational Resources Information Center

    Irby, David; Rakestraw, Philip

    1981-01-01

    Medical students have been rating clinical teaching in an obstetrics and gynecology clerkship at the University of Washington using an assessment form designed to reflect six factors of clinical teaching effectiveness. High interrater reliability and the utility of the data for faculty development and advancement are discussed. (Author/JMD)

  2. Scaling-Up Access to Antiretroviral Therapy for Children: A Cohort Study Evaluating Care and Treatment at Mobile and Hospital-Affiliated HIV Clinics in Rural Zambia

    PubMed Central

    van Dijk, Janneke H.; Moss, William J.; Hamangaba, Francis; Munsanje, Bornface; Sutcliffe, Catherine G.

    2014-01-01

    Background Travel time and distance are barriers to care for HIV-infected children in rural sub-Saharan Africa. Decentralization of care is one strategy to scale-up access to antiretroviral therapy (ART), but few programs have been evaluated. We compared outcomes for children receiving care in mobile and hospital-affiliated HIV clinics in rural Zambia. Methods Outcomes were measured within an ongoing cohort study of HIV-infected children seeking care at Macha Hospital, Zambia from 2007 to 2012. Children in the outreach clinic group received care from the Macha HIV clinic and transferred to one of three outreach clinics. Children in the hospital-affiliated clinic group received care at Macha HIV clinic and reported Macha Hospital as the nearest healthcare facility. Results Seventy-seven children transferred to the outreach clinics and were included in the analysis. Travel time to the outreach clinics was significantly shorter and fewer caretakers used public transportation, resulting in lower transportation costs and fewer obstacles accessing the clinic. Some caretakers and health care providers reported inferior quality of service provision at the outreach clinics. Sixty-eight children received ART at the outreach clinics and were compared to 41 children in the hospital-affiliated clinic group. At ART initiation, median age, weight-for-age z-scores (WAZ) and CD4+ T-cell percentages were similar for children in the hospital-affiliated and outreach clinic groups. Children in both groups experienced similar increases in WAZ and CD4+ T-cell percentages. Conclusions HIV care and treatment can be effectively delivered to HIV-infected children at rural health centers through mobile ART teams, removing potential barriers to uptake and retention. Outreach teams should be supported to increase access to HIV care and treatment in rural areas. PMID:25122213

  3. Evaluation of several ultrasonography scoring systems for synovitis and comparison to clinical examination: results from a prospective multicentre study of rheumatoid arthritis.

    PubMed

    Dougados, Maxime; Jousse-Joulin, Sandrine; Mistretta, Frederic; d'Agostino, Maria-Antonietta; Backhaus, Marina; Bentin, Jacques; Chalès, Gérard; Chary-Valckenaere, Isabelle; Conaghan, Philip; Etchepare, Fabien; Gaudin, Philippe; Grassi, Walter; van der Heijde, Désirée; Sellam, Jérémie; Naredo, Esperanza; Szkudlarek, Marcin; Wakefield, Richard; Saraux, Alain

    2010-05-01

    To evaluate different global ultrasonographic (US) synovitis scoring systems as potential outcome measures of rheumatoid arthritis (RA) according to the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) filter. To study selected global scoring systems, for the clinical, B mode and power Doppler techniques, the following joints were evaluated: 28 joints (28-joint Disease Activity Score (DAS28)), 20 joints (metacarpophalangeals (MCPs) + metatarsophalangeals (MTPs)) and 38 joints (28 joints + MTPs) using either a binary (yes/no) or a 0-3 grade. The study was a prospective, 4-month duration follow-up of 76 patients with RA requiring anti-tumour necrosis factor (TNF) therapy (complete follow-up data: 66 patients). Intraobserver reliability was evaluated using the intraclass correlation coefficient (ICC), construct validity was evaluated using the Cronbach alpha test and external validity was evaluated using level of correlation between scoring system and C reactive protein (CRP). Sensitivity to change was evaluated using the standardised response mean. Discriminating capacity was evaluated using the standardised mean differences in patients considered by the doctor as significantly improved or not at the end of the study. Different clinimetric properties of various US scoring systems were at least as good as the clinical scores with, for example, intraobserver reliability ranging from 0.61 to 0.97 versus from 0.53 to 0.82, construct validity ranging from 0.76 to 0.89 versus from 0.76 to 0.88, correlation with CRP ranging from 0.28 to 0.34 versus from 0.28 to 0.35 and sensitivity to change ranging from 0.60 to 1.21 versus from 0.96 to 1.36 for US versus clinical scoring systems, respectively. This study suggests that US evaluation of synovitis is an outcome measure at least as relevant as physical examination. Further studies are required in order to achieve optimal US scoring systems for monitoring patients with RA in clinical trials and in clinical

  4. Clinical Evaluation of Proclination of Lower Anterior Teeth during Alignment using a Single Width Bracket-A Pilot Study

    PubMed Central

    Farhan, Azeem; Issar, Rashmi; Subramanian, Shashikala; Muniyappa, Manju Prasad; Ranjan, Shashi; Singh, Priyankar; Singh, Kumar Tathagat

    2016-01-01

    Introduction The pre-adjusted brackets are available in various prescriptions and sizes; nevertheless there are still many controversies as to which pre-adjusted edgewise bracket offers the maximum clinical efficiency. Aim This study was conducted to determine and compare the amount of lower incisor proclination during de-crowding if any of the Mini-Uni Twin Brackets with that of the standard double width brackets. Materials and Methods A total of 20 patients i.e., 10 patients in each group both males and females were randomly selected for the study from subjects seeking treatment, the selected samples were grouped as follows. Group I – Double Width Brackets (3M Unitek Gemini Series) 0.018” slot with Roth prescription. Group II – Mini Uni-Twin Bracket (3M Unitek) 0.018” slot with Roth prescription. Results The Mini-Uni Twin Brackets had statistically significant (p = 0.01) amount of proclination of the lower anteriors (0.8o± 0.3o) after de-crowding as compared to the standard Double Width Brackets and since the mean change in the Incisor Mandibular Plane Angle (IMPA) was lesser than 1o, its clinical significance could be questionable. Conclusion The Mini Uni Twin brackets are comparatively efficient in the lower anterior decrowding but further comparative clinical studies need to be performed on these Mini Uni Twin brackets, with an increase in the sample size and also the number of parameters to prove its total clinical efficiency. PMID:27504401

  5. Deep Inspiration Breath Hold [(18)F]FDG PET-CT on 4-rings scanners in evaluating lung lesions: evidences from a phantom and a clinical study.

    PubMed

    Caobelli, Federico; Puta, Erinda; Kaiser, Stefano Ren; Massetti, Valentina; Andreoli, Michela; Mostarda, Angelica; Soffientini, Alberto; Pizzocaro, Claudio; Guerra, Ugo Paolo

    2014-01-01

    To investigate the clinical feasibility of a Deep Inspiration Breath Hold (DIBH) (18)F-FDG PET-CT acquisition in apnea and compare the results obtained between these acts of acquisition in apnea and in Free Breathing in the evaluation of lung lesions. A pre-clinical phantom study was performed to evaluate the shortest simulated DIBH time according to the minimum detectable lesion that can be detected by our ultrasound scanner. This study was conducted by changing acquisition time and sphere-to-background activity ratio values and by using radioactivity densities similar to those generally found in clinical examinations. In the clinical study, 25 patients with pulmonary lesions underwent a standard whole body (18)F-FDG PET-CT scan in free breathing followed by a 20s single thorax acquisition PET/CT in DIBH acquisition. The phantom study indicated that a 20-s acquisition time provides an accurate evaluation of smallest sphere shaped lesions. In the clinical study, PET-CT scans obtained in DIBH studies showed a significant reduction of misalignment between the PET and CT scan images and an increase of SUVmax compared to free breathing acquisitions. A correlation between the %BH-index and lesion displacement between PET and CT images in FB acquisition was demonstrated, significantly higher for lesions with a displacement>8mm. The single 20s acquisition of DIBH PET-CT is a feasible technique for lung lesion detection in the clinical setting. It only requires a minor increase in examination time without special patient training. 20s DIBH scan provided a more precise measurement of SUVmax, especially for lesions in the lower lung lobes which usually show greater displacement between PET and CT scan images in FB acquisition. Copyright © 2013 Elsevier España, S.L. and SEMNIM. All rights reserved.

  6. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART)

    USDA-ARS?s Scientific Manuscript database

    Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (L...

  7. Mucosal function and breath hydrogen excretion: comparative studies in the clinical evaluation of children with nonspecific abdominal complaints.

    PubMed

    Barr, R G; Watkins, J B; Perman, J A

    1981-10-01

    To evaluate the role of the lactose breath hydrogen test for the detection of lactose malabsorption in children with chronic nonspecific abdominal complaints, breath hydrogen excretion was measured in 131 children with recurrent abdominal pain (n = 75) or chronic nonspecific diarrhea (n = 56) following a lactose load (2 gm/kg; maximum 50 gm). The data were compared to those obtained from lactose tolerance tests (n = 113) and symptom response following a lactose load (n = 109) performed simultaneously with the lactose breath hydrogen test, and with results from small bowel biopsies obtained in 31 children to determine dissacharidase activity and mucosal histology. The results indicate that an increase in breath hydrogen of greater than 10 ppm above base line values (delta ppm) by 120 minutes ("early increase" response) completely discriminates between biopsy-proven isolated lactase-insufficient and lactase-sufficient children. A similar increase after 120 minutes ("late increase" response) is consistent both with normal mucosal function and partial lactase insufficiency due to mucosal injury. Breath hydrogen responses predicted assayed lactase activity in all patients with isolated lactase insufficiency, but were "falsely negative" in four of ten children whose lactase insufficiency was secondary to mucosal injury. In both clinical groups, lactose malabsorbers report significantly more symptoms than absorbers (P less than .001), but neither symptom reports nor tolerance tests are accurate methods for distinguishing lactose malabsorbers from absorbers. Although the lactose breath hydrogen test provides objective documentation of lactose malabsorption, it is equally predictive of assayed lactase activity in all clinical groups.

  8. Evaluation of the Success Criteria for Zirconia Dental Implants: A Four-Year Clinical and Radiological Study

    PubMed Central

    Borgonovo, Andrea Enrico; Vavassori, Virna; Calvo-Guirado, Josè Luis; Delgado Ruiz, Rafael Arcesio; Maiorana, Carlo

    2013-01-01

    Objectives. The aim was to evaluate survival and success rates, soft tissue health, and radiographic marginal bone loss (MBL) of zirconia implants placed in the esthetic and posterior areas of the jaws and in association with multiple or single implant restorations after at least 6 months of definitive restoration. Material and Methods. 35 one-piece zirconium implants were utilized for single or partially edentulous ridges rehabilitation. All implants received immediate temporary restorations and six months after surgery were definitively restored. Every 6 months after implant placement, a clinical-radiographic evaluation was performed. For each radiograph, the measurements of MBL were calculated. Results. The results showed that the mean MBL at 48-month followup was 1.631 mm. The mean MBL during the first year of loading was not more significant for implants placed in the first molar regions than for those positioned in other areas. Moreover, no differences in marginal bone level changes were revealed for multiple and single implants, whereas MBL in the first year was observed to be slightly greater for implants placed in the maxilla than for those placed in the mandible. Conclusion. Zirconia showed a good marginal bone preservation that could be correlated with one-piece morphology and characteristics of zirconia implants. PMID:24065992

  9. Experimental studies: randomized clinical trials.

    PubMed

    Gjorgov, A N

    1998-01-01

    There are two major approaches to medical investigations: observational studies and experimental trials. The classical application of the experimental design to studies of human populations is the randomized clinical trial of the efficacy of a new drug or treatment. A further application of the experimental studies is to the testing of hypotheses about the etiology of a disease, already tested and corroborated from various forms of observational studies. Ethical considerations and requirements for consent of the experimental subjects are of primary concern in the clinical trials, and those concerns set the first and final limits for implementing a trial. General moral principles in research with human and animal beings, defined by the "Nuremberg Code," deal with strict criteria for approval, endorsement and evaluation of a clinical trial.

  10. Uncovering a clinical portrait of sluggish cognitive tempo within an evaluation for attention-deficit/hyperactivity disorder: A case study.

    PubMed

    Becker, Stephen P; Ciesielski, Heather A; Rood, Jennifer E; Froehlich, Tanya E; Garner, Annie A; Tamm, Leanne; Epstein, Jeffery N

    2016-01-01

    Despite the burgeoning scientific literature examining the sluggish cognitive tempo (SCT) construct, very little is known about the clinical presentation of SCT. In clinical cases where SCT is suspected, it is critical to carefully assess not only for attention-deficit/hyperactivity disorder (ADHD) but also for other comorbidities that may account for the SCT-related behaviors, especially internalizing symptoms and sleep problems. The current case study provides a clinical description of SCT in a 7-year-old girl, offering a real-life portrait of SCT while also providing an opportunity to qualitatively differentiate between SCT and ADHD, other psychopathologies (e.g. depression, anxiety), and potentially related domains of functioning (e.g. sleep, executive functioning [EF]). "Jessica" was described by herself, parents, and teacher as being much slower than her peers in completing schoolwork, despite standardized testing showing Jessica to have above average intelligence and academic achievement. Jessica's parents completed rating scales indicating high levels of SCT symptoms and daytime sleepiness, as well as mildly elevated EF deficits. More research is needed to determine how to best conceptualize, assess, and treat SCT, and Jessica's case underscores the importance of further work in this area. © The Author(s) 2014.

  11. Clinical Evaluation of Success of Primary Teeth Pulpotomy Using Mineral Trioxide Aggregate(®), Laser and Biodentine(TM)- an In Vivo Study.

    PubMed

    Niranjani, Krothapalli; Prasad, Madhu Ghanshyam; Vasa, Aron Arun Kumar; Divya, Gaddam; Thakur, Mukesh Singh; Saujanya, Kanithi

    2015-04-01

    Pulpotomy technique basically consists of removing the coronal pulp and fixing the radicular pulp with a medicament. It is the most widely accepted clinical procedure for treating primary teeth with coronal pulp inflammation caused by caries with no involvement of the radicular pulp. To evaluate the success and efficacy of Mineral Trioxide Aggregate (MTA), Lasers and Biodentine as pulpotomy agents both clinically and radiographically. In the present study, 60 primary molars in children whose pulpal status warranted pulpotomy were selected and randomly assigned into three groups that included MTA, Laser and Biodentine allocating 20 teeth to each group. The pulpotomy procedure was then performed on all selected teeth followed by restoration with stainless steel crowns. Later the patients were recalled for 3 months and 6 months for clinical and radiographic evaluation. Statistical analysis was done using Fisher exact test to determine pair wise comparison of three agents with respect to clinical and radiographic criteria. Kruskal-Wallis ANOVA, Mc Nemars test was applied to evaluate the efficacy of each agent between 3 months and 6 months. The results showed that maximum success rate was found in MTA group. However, the comparison between three groups was statistically not significant (p<0.05). Pulpotomies performed with either MTA, Laser or Biodentine are equally efficient with similar clinical/radiographic success and hence can be considered as alternatives to Formocresol.

  12. Clinical Evaluation of Success of Primary Teeth Pulpotomy Using Mineral Trioxide Aggregate®, Laser and BiodentineTM- an In Vivo Study

    PubMed Central

    Prasad, Madhu Ghanshyam; Vasa, Aron Arun Kumar; Divya, Gaddam; Thakur, Mukesh Singh; Saujanya, Kanithi

    2015-01-01

    Introduction Pulpotomy technique basically consists of removing the coronal pulp and fixing the radicular pulp with a medicament. It is the most widely accepted clinical procedure for treating primary teeth with coronal pulp inflammation caused by caries with no involvement of the radicular pulp. Aim To evaluate the success and efficacy of Mineral Trioxide Aggregate (MTA), Lasers and Biodentine as pulpotomy agents both clinically and radiographically. Materials and Methods In the present study, 60 primary molars in children whose pulpal status warranted pulpotomy were selected and randomly assigned into three groups that included MTA, Laser and Biodentine allocating 20 teeth to each group. The pulpotomy procedure was then performed on all selected teeth followed by restoration with stainless steel crowns. Later the patients were recalled for 3 months and 6 months for clinical and radiographic evaluation. Results Statistical analysis was done using Fisher exact test to determine pair wise comparison of three agents with respect to clinical and radiographic criteria. Kruskal-Wallis ANOVA, Mc Nemars test was applied to evaluate the efficacy of each agent between 3 months and 6 months. The results showed that maximum success rate was found in MTA group. However, the comparison between three groups was statistically not significant (p<0.05). Conclusion Pulpotomies performed with either MTA, Laser or Biodentine are equally efficient with similar clinical/radiographic success and hence can be considered as alternatives to Formocresol. PMID:26023640

  13. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study.

    PubMed

    Hugar, Shivayogi M; Kukreja, Pratibha; Hugar, Shweta S; Gokhale, Niraj; Assudani, Harsha

    2017-01-01

    Despite various advents in technology, the present era marks a shift to phytotherapeutics and alternative modalities to conventional endodontic treatments. Newer endodontic modalities have been developed inculcating the ancient system of medicine. The present study was done to compare and evaluate the clinical pulp response and radiographic signs after pulpotomy in four groups of primary molar teeth treated with formocresol (control), propolis extract, turmeric gel, and calcium hydroxide respectively. Following ethical clearance, 90 primary molar teeth in 45 pediatric patients, aged between 4 and 9 years, were selected for pulpotomy. These were then randomly divided by split-mouth technique into two groups as experimental (propolis extract/turmeric gel/calcium hydroxide) and control (formocresol) groups. The patients were followed up for 6 months for clinical and radiographic signs and symptoms to evaluate the success of treatment. A comparable clinical and radiographic success rate was seen with all experimental groups as compared to the control (formocresol) group. With concerns about the safety of formocresol appearing in the dental and medical literature for more than 20 years, the materials used in this study can be considered as promising alternatives for formocresol in pediatric endodontic treatment. Hugar SM, Kukreja P, Hugar SS, Gokhale N, Assudani H. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study. Int J Clin Pediatr Dent 2017;10(1):18-23.

  14. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study

    PubMed Central

    Hugar, Shivayogi M; Hugar, Shweta S; Gokhale, Niraj; Assudani, Harsha

    2017-01-01

    Aims Despite various advents in technology, the present era marks a shift to phytotherapeutics and alternative modalities to conventional endodontic treatments. Newer endodontic modalities have been developed inculcating the ancient system of medicine. The present study was done to compare and evaluate the clinical pulp response and radiographic signs after pulpotomy in four groups of primary molar teeth treated with formocresol (control), propolis extract, turmeric gel, and calcium hydroxide respectively. Materials and methods Following ethical clearance, 90 primary molar teeth in 45 pediatric patients, aged between 4 and 9 years, were selected for pulpotomy. These were then randomly divided by split-mouth technique into two groups as experimental (propolis extract/turmeric gel/calcium hydroxide) and control (formocresol) groups. The patients were followed up for 6 months for clinical and radiographic signs and symptoms to evaluate the success of treatment. Results A comparable clinical and radiographic success rate was seen with all experimental groups as compared to the control (formocresol) group. Conclusion With concerns about the safety of formocresol appearing in the dental and medical literature for more than 20 years, the materials used in this study can be considered as promising alternatives for formocresol in pediatric endodontic treatment. How to cite this article Hugar SM, Kukreja P, Hugar SS, Gokhale N, Assudani H. Comparative Evaluation of Clinical and Radiographic Success of Formocresol, Propolis, Turmeric Gel, and Calcium Hydroxide on Pulpotomized Primary Molars: A Preliminary Study. Int J Clin Pediatr Dent 2017;10(1):18-23. PMID:28377649

  15. Comparative evaluation of mineral trioxide aggregate and bioaggregate as apical barrier material in traumatized nonvital, immature teeth: A clinical pilot study.

    PubMed

    Tuloglu, N; Bayrak, S

    2016-01-01

    Clinical research examining the use of mineral trioxide aggregate (MTA) as an apical barrier material are limited, and no studies have so far examined the clinical performance of BioAggregate as apical barrier material in nonvital immature teeth. This study was aimed to provide a comparative evaluation of the clinical and radiographic success of MTA and BioAggregate as an apical barrier material in children with traumatized nonvital, immature permanent maxillary incisors. A total of 26 maxillary incisor teeth in 20 children aged 7-11 were chosen for this study. Teeth were randomly divided into two groups according to the material to be applied, and the apical barrier was performed. Following treatment, for 24-month, teeth were clinically and radiographically evaluated once every 3- and 6-month, respectively. All teeth treated with MTA and BioAggregate were clinically and radiographically successful throughout the 24-month follow-up period. Similar success was achieved in the apical barrier that using BioAggregate and MTA. BioAggregate would be considered suitable materials for apical barrier technique and can be used as an alternative to MTA.

  16. Clinical judgment: the last frontier for evaluation.

    PubMed

    Lasater, Kathie

    2011-03-01

    Nursing educators and preceptors often find it difficult to evaluate prelicensure students' clinical judgment development. Clinical judgment is critical to excellent patient care decisions and outcomes. The Lasater Clinical Judgment Rubric, a validated, evidence-based clinical judgment rubric, is described as a tool that offers a common language for students, nurse educators, and preceptors and a trajectory for students' clinical judgment development. The rubric has been used to provide feedback for reflective journals and a means for self-evaluation in addition to a guide for formulating higher level thought questions to shape students' thinking like a nurse.

  17. Clinical evaluation of clobetasone butyrate: a comparative study of its effects in postoperative inflammation and on intraocular pressure.

    PubMed Central

    Ramsell, T G; Bartholomew, R S; Walker, S R

    1980-01-01

    Clobetasone butyrate, a new corticosteroid with a high topical activity, has been compared with prednisolone phosphate and a placebo in the treatment of inflammation following cataract extraction. These 2 steroids were more effective in relieving postoperative inflammation than placebo (P less than 0.05), though no obvious clinical differences between the 2 compounds emerged from this investigation. However, a single-blind comparative study against betamethasone phosphate in patients suspected of having steroid-induced glaucoma showed that, while betamethasone phosphate significantly raised intraocular pressure, clobetasone butyrate had only a minimal effect, and this difference was statistically significant (P less than 0.02). PMID:6986899

  18. A comparative clinical study evaluating stain removal efficacy of a new sensitivity whitening dentifrice compared to commercially available whitening dentifrices.

    PubMed

    Hughes, Nathan; Maggio, Brenda; Sufi, Farzana; Mason, Stephen; Kleber, Carl J

    2009-01-01

    To assess the extrinsic stain removal efficacy of a new sensitivity dentifrice containing sodium tripolyphosphate (STP) to marketed whitening toothpastes after six weeks of product use. This was a single-center, double-blind, stratified, six-week clinical study comparing the reduction in stain area and intensity of Sensodyne Extra Whitening to Crest Maximum Strength Sensitivity Protection Whitening plus Scope and Colgate Tartar Control Plus Whitening Mint dentifrice, as measured by MacPherson's Modification of the Lobene Stain Index (MMLSI) in a forced stain model. Two-hundred and ninety-five subjects completed the study. Tooth stain MMSLI scores showed significant differences between Sensodyne and Crest dentifrices in favor of Sensodyne for all surface sites (p = 0.014), and individually for facial (p = 0.023), lingual (p = 0.027), and interproximal (p = 0.014) surfaces. No significant statistical differences between Sensodyne and Colgate dentifrices were observed for any of the surfaces. Results from this stain removal clinical study demonstrate significant extrinsic stain removal efficacy for all dentifrices relative to baseline. Significant differences between the two marketed sensitivity whitening dentifrices were demonstrated in favor of the new Sensodyne Sensitivity Whitening dentifrice.

  19. Evaluation of a moisturising micro-gel spray for prevention of cell dryness in oral mucosal cells: an in vitro study and evaluation in a clinical setting.

    PubMed

    Ota, Y; Morito, A; Fujisawa, K; Nishida, M; Hata, H; Ueno, T; Yurikusa, T; Murata, T

    2012-11-01

    A moisturising micro-gel spray for prevention of dryness was compared with commercial products and artificial saliva in vitro and in a clinical setting in patients with cancer. Survival of cultured human gingival epithelial cells was evaluated after treatment with each product for 15 min. A dry test was performed for products giving a 50% survival rate, in which cell survival was measured after drying of cells treated with each product. The survival rates of cells treated with the micro-gel spray and artificial saliva were significantly higher than those of control cells. The micro-gel spray was then evaluated for 1 week in patients with symptoms of dry mouth caused by cancer treatment. There was significant improvement of these symptoms at night and on awakening and of subjective symptoms of decreased salivary volume (P < 0.05). Mean visual analogue scale scores also significantly decreased (P < 0.01). These data suggest that evaluation of moisturising products for dryness prevention can be performed in cultured cells, since products that performed well in vitro also showed good efficacy for symptoms of dry mouth. The micro-gel spray was particularly effective for relieving symptoms of dry mouth in patients with cancer.

  20. Evaluation of a moisturising micro-gel spray for prevention of cell dryness in oral mucosal cells: an in vitro study and evaluation in a clinical setting

    PubMed Central

    Ota, Y; Morito, A; Fujisawa, K; Nishida, M; Hata, H; Ueno, T; Yurikusa, T; Murata, T

    2012-01-01

    A moisturising micro-gel spray for prevention of dryness was compared with commercial products and artificial saliva in vitro and in a clinical setting in patients with cancer. Survival of cultured human gingival epithelial cells was evaluated after treatment with each product for 15 min. A dry test was performed for products giving a 50% survival rate, in which cell survival was measured after drying of cells treated with each product. The survival rates of cells treated with the micro-gel spray and artificial saliva were significantly higher than those of control cells. The micro-gel spray was then evaluated for 1 week in patients with symptoms of dry mouth caused by cancer treatment. There was significant improvement of these symptoms at night and on awakening and of subjective symptoms of decreased salivary volume (P < 0.05). Mean visual analogue scale scores also significantly decreased (P < 0.01). These data suggest that evaluation of moisturising products for dryness prevention can be performed in cultured cells, since products that performed well in vitro also showed good efficacy for symptoms of dry mouth. The micro-gel spray was particularly effective for relieving symptoms of dry mouth in patients with cancer. PMID:22519950

  1. An evaluation of microbial profile in halitosis with tongue coating using PCR (polymerase chain reaction)- a clinical and microbiological study.

    PubMed

    Kamaraj R, Dinesh; Bhushan, Kala S; K L, Vandana

    2014-01-01

    Medline search using key words halitosis, tongue coating, polymerase chain reaction, microbial profile did not reveal any study. Hence, the purpose of the present investigation was to assess the malodor using the organoleptic method and tanita device; to quantify odoriferous microorganisms using Polymerase Chain Reaction technique in chronic periodontitis patients. The study included 30 chronic periodontitis patients. Halitosis was detected using organoleptic assessment & tanita breath alert. Microbial analysis of Pg, Tf & Fn was done using PCR. Plaque index (PI), gingival index (GI), gingival bleeding index (GBI) were recorded. The maximum score of 3 for tongue coating was found in 60% of selected subjects. The tanita breath alert measured VSC level of score 2 in 60% of selected subjects while organoleptic score of 4 was found in 50% of subjects. The maximum mean value of 31.1±36.5 was found to be of F. nucleatum (Fn) followed by P. gingivalis (Pg) (13±13.3) & T. forsythia (Tf) (7.16±8.68) in tongue samples of selected patients. A weak positive correlation was found between VSC levels (tanita score & organoleptic score) and clinical parameters. The halitosis assessment by measuring VSC levels using organoleptic method and tanita breath alert are clinically feasible. Maximum tongue coating was found in 60% of patients. Fn was found comparatively more than the Pg & Tf. A weak positive correlation was found between VSC levels and clinical parameters such as PI, GI & GBI. Thus,the dentist/ periodontist should emphasise on tongue cleaning measures that would reduce the odoriferous microbial load.

  2. The Effect of Formative Program Evaluation on Continuous Program Improvement: A Case Study of a Clinical Training Program in Lao PDR.

    PubMed

    Yoon, Hyun Bae; Shin, Jwa-Seop; Lee, Seung-Hee; Kim, Do-Hwan; Hwang, Jinyoung; Kim, Eun Jung; Bouphavanh, Ketsomsouk

    2015-12-01

    This study aimed to evaluate the effect of the formative program evaluation on the continuous improvement of a clinical training program for Lao health professionals. The training program was conducted 4 times consecutively for total 48 health professionals, and the formative program evaluation was carried out during the whole process. To evaluate the satisfaction and the transfer of the trainees, the questionnaire survey, the focus group interview, and the trainees' medical records were used. After the end of each batch of the program, the evaluation data were analyzed, and its results were shared with the training management committee and the trainers, who, based on the results, reached a consensus on how to improve the program. The evaluation results and the comparison of them among the four batches of the program showed that there was a continuous increase of the satisfaction and the transfer of the trainees, especially in the early period of the program. The formative program evaluation which was conducted during the whole process of the clinical training program had a positive effect on the improvement of the program, especially in the early phase, by increasing the satisfaction and transfer of the trainees.

  3. Residency evaluation and adherence design study: Young ophthalmologists' perception of their residency programs - Clinical and surgical skills.

    PubMed

    Gogate, Parikshit; Biswas, Partha; Natarajan, Sundaram; Ramamurthy, Dandapani; Bhattacharya, Debashish; Golnik, Karl; Nayak, Barun Kumar

    2017-06-01

    Residency training is the basis of good clinical and surgical practice. The aim is to know the demographics, training experience, and perception of young ophthalmologists to improve the present residency programs in India. Young ophthalmologists trained in India. A survey was conducted by the Academic and Research Committee of the All India Ophthalmology Society, in 2014-2016 of young ophthalmologists (those trained between 2002 and 2012, with 2-10 years' postresidency experience) to gauge teaching of clinical and surgical skills during the postgraduate residency program. Statistical Package for Social Sciences version 16. Of the 1005 respondents, 531 fulfilled inclusion criteria. Average age was 32.6 years (standard deviation [SD] 4). On a scale of 0-10, clinical skills teaching was graded as (mean, SD): Slit lamp examination (7.2, SD 2.8), indirect ophthalmoscopy (6.2, SD 3.3), gonioscopy (5.7, SD 3.4), perimetry (6.2, SD 3.2), optical coherence tomography (4.6, SD 4), and orthoptic evaluation (4.3, SD 3.1). The mean (SD) and median of surgeries performed independently was intracapsular cataract extraction 3.0 (14.9), 0; extracapsular cataract extraction 39.9 (53.2), 18; small incision cataract surgery 75.3 (64.4), 55; phacoemulsification 30 (52.6), 1; pterygium excision 31.5 (43.5), 15; dacryocystectomy 20.3 (38.1), 4; dacryocystorhinostomy 11.7 (26.2), 2; chalazion 46.4 (48.3), 30; trabeculectomies 4 (14.9), 0; strabismus correction 1.4 (4.9), 0; laser-assisted in situ Keratomileusis 1.5 (12.2), 0; retinal detachment 1.5 (12.5), 0; vitrectomy 3.0 (17.0), 0; keratoplasty 5.2 (17.8), 0; eyelid surgery 8.6 (18.9), 2 and ocular emergencies 41.7 (52.4), 20. Observed and assisted surgeries were more common. However, the range of grading was 0-10 in all categories. Residency training in India varies considerably from program to program. Standardization is needed to assure all graduates are competent and render consistent quality of service.

  4. A pragmatic method for transforming clinical research data from the research electronic data capture "REDCap" to Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM): Development and evaluation of REDCap2SDTM.

    PubMed

    Yamamoto, Keiichi; Ota, Keiko; Akiya, Ippei; Shintani, Ayumi

    2017-06-01

    The Clinical Data Interchange Standards Consortium (CDISC) Study Data Tabulation Model (SDTM) can be used for new drug application studies as well as secondarily for creating a clinical research data warehouse to leverage clinical research study data across studies conducted within the same disease area. However, currently not all clinical research uses Clinical Data Acquisition Standards Harmonization (CDASH) beginning in the set-up phase of the study. Once already initiated, clinical studies that have not utilized CDASH are difficult to map in the SDTM format. In addition, most electronic data capture (EDC) systems are not equipped to export data in SDTM format; therefore, in many cases, statistical software is used to generate SDTM datasets from accumulated clinical data. In order to facilitate efficient secondary use of accumulated clinical research data using SDTM, it is necessary to develop a new tool to enable mapping of information for SDTM, even during or after the clinical research. REDCap is an EDC system developed by Vanderbilt University and is used globally by over 2100 institutions across 108 countries. In this study, we developed a simulated clinical trial to evaluate a tool called REDCap2SDTM that maps information in the Field Annotation of REDCap to SDTM and executes data conversion, including when data must be pivoted to accommodate the SDTM format, dynamically, by parsing the mapping information using R. We confirmed that generating SDTM data and the define.xml file from REDCap using REDCap2SDTM was possible. Conventionally, generation of SDTM data and the define.xml file from EDC systems requires the creation of individual programs for each clinical study. However, our proposed method can be used to generate this data and file dynamically without programming because it only involves entering the mapping information into the Field Annotation, and additional data into specific files. Our proposed method is adaptable not only to new drug

  5. Evaluation of “Subject Advocate” Procedures in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) Schizophrenia Study

    PubMed Central

    Stroup, T Scott; Appelbaum, Paul S

    2006-01-01

    Because the decision-making capacity of individuals with schizophrenia may fluctuate, additional protections for such persons who enroll in long-term research studies may be needed. For the NIMH-sponsored Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) schizophrenia study, new procedures were developed to help ensure an objective assessment of a patient's continued participation in the study if decision-making capacity lapsed. Each research participant had a subject advocate who could recommend that the subject be withdrawn from the study if capacity lapsed and continued participation was not in the subject's best interest. The main goals of the procedures were to protect the interests of subjects and to prevent unnecessary dropouts. We surveyed research personnel regarding the effectiveness and implementation of the procedures. Responses were received from 73 personnel at 49 research sites, representing 70% of possible respondents and 91% of eligible sites. A majority of respondents were favorably disposed toward subject advocates, and though most reported that the procedures had no discernible effect on study recruitment, subject autonomy, or subject retention, for those who reported an impact, it was almost always positive. Some respondents reported that the procedures helped by engaging family members and promoting a positive view of schizophrenia research. A majority thought that similar arrangements would be useful in future longitudinal research studies. Nonspecific benefits included good public relations and engagement of family members. Improved training regarding the procedures may be needed to achieve specific goals of enhanced patient autonomy and retention in the study. PMID:16282635

  6. [Evaluation of eight Clinical Protocols and Therapeutic Guidelines under the Brazilian Ministry of Health using the AGREE II instrument: a pilot study].

    PubMed

    Ronsoni, Ricardo De March; Pereira, Claudia Cristina de Aguiar; Stein, Airton Tetelbom; Osanai, Mário Henrique; Machado, Carla Jorge

    2015-06-01

    The number of clinical guidelines is increasing worldwide, while there are concerns regarding their quality. In 2000, the Brazilian Ministry of Health began its process of creating clinical guidelines, called Clinical Protocols and Therapeutic Guidelines (PCDT). The goal of this study was to assess the quality of Brazilian guidelines approved since 2009 using the AGREE II instrument (Appraisal of Guidelines for Research and Evaluation). We identified 59 PCDT from 2009 to 2012, of which eight were randomly selected and evaluated by three independent evaluators. For the item "recommends the guidelines", two evaluators recommended the use of all eight, but with modifications, and one did not recommend any to the guidelines. Regarding the item "global quality of the guidelines" (varying from 1 to 7), the mean was 4.25 (SD = 0.46). The results showed the need for adjustments in the PCDT in relation to AGREE II domains. However, due to the instrument's limitations, further studies are needed, including the quality of evidence used in the PCDT.

  7. [Effectiveness of German disease management programs--problems of clinical evaluation research in the light of a study protocol].

    PubMed

    Beyer, Martin; Gensichen, Jochen; Szecsenyi, Joachim; Wensing, Michel; Gerlach, Ferdinand M

    2006-01-01

    Since 2002 some of the world's largest disease management programs have been launched in Germany--initially for type II diabetes and coronary heart disease--with approximately 5 million eligible insured persons and (in 2005) 2.04 million registered participants. The programs were not piloted prior to their start, and the prescribed statutory evaluation cannot be expected to result in an effectiveness validation. The article describes the development of a study protocol for a randomized controlled trial. It also discusses methodological problems, in particular the definition of primary target criteria, the guarantee of a 'naturalistic' intensity of intervention, and the creation of a control group during nation-wide implementation. Due to lacking support from the stakeholders the proposed randomized trial could not be implemented. Its design, however, allows the required standards for the program evaluation to be specified.

  8. Prevalence of abuse and intimate partner violence surgical evaluation (PRAISE) in orthopaedic fracture clinics: a multinational prevalence study.

    PubMed

    Sprague, Sheila; Bhandari, Mohit; Della Rocca, Gregory J; Goslings, J Carel; Poolman, Rudolf W; Madden, Kim; Simunovic, Nicole; Dosanjh, Sonia; Schemitsch, Emil H

    2013-09-07

    Intimate partner violence (IPV) is the leading cause of non-fatal injury to women worldwide. Musculoskeletal injuries, which are often seen by orthopaedic surgeons, are the second most common manifestation of IPV. We aimed to establish the 12-month and lifetime prevalence of IPV in women presenting to orthopaedic fracture clinics. The PRAISE team of 80 investigators did a cross-sectional study of a consecutive sample of 2945 female participants at 12 orthopaedic fracture clinics in Canada, the USA, the Netherlands, Denmark, and India. Participants who met the eligibility criteria anonymously answered direct questions about physical, emotional, and sexual IPV, and completed two previously developed questionnaires (Women Abuse Screening Tool [WAST] and Partner Violence Screen [PVS]). We did a multivariable logistic regression analysis to investigate the risk factors associated with IPV. The overall response rate was 85% (2344 of 2759 patients provided informed consent). One in six women (455/2839, 16·0%, 95% CI 14·7-17·4%) disclosed a history of IPV within the past year, and one in three (882/2550, 34·6%, 32·8-36·5%) had experienced IPV in their lifetime. 49 women (1·7%, 1·3-2·2%) attended their clinic visit as a direct consequence of IPV, only seven of whom (14%) had ever been asked about IPV in a health-care setting. Women in short-term relationships (OR 0·584, 99% CI 0·396-0·860, p=0·0001) were at increased risk of IPV and physical abuse in the past 12 months in this study. Compared with women in Canada and the USA, those in the Netherlands and Denmark were at reduced risk of any abuse in the past 12 months, physical abuse in lifetime, and any abuse in lifetime (OR 0·595, 99% CI 0·427-0·830, p<0·0001; 0·630, 0·445-0·890, p=0·001; and 0·464, 0·352-0·612, p<0·0001, respectively). PRAISE is the largest prevalence study done so far in orthopaedics. Orthopaedic surgeons should be confident in the assumption that one in six women have a history

  9. Performance Evaluation of a Clinical PACS Module

    NASA Astrophysics Data System (ADS)

    Taira, Ricky K.; Cho, Paul S.; Huang, H. K.; Mankovich, Nicholas J.; Boechat, Maria I.

    1989-05-01

    Picture archiving and communication systems (PACS) are now clinically available in limited radiologic applications. The benefits, acceptability, and reliablity of these systems have thus far been mainly speculative and anecdotal. This paper discusses the evaluation of a PACS module implemented in the pediatric radiology section of a 700-bed teaching hospital. The PACS manages all pediatric inpatient images including conventional x-rays and contrast studies (obtained with a computed radiography system), magnetic resonance images, and relevant ultrasound images. A six-monitor workstation is available for image review.

  10. Clinical Performance of Prediction Rules and Nasogastric Lavage for the Evaluation of Upper Gastrointestinal Bleeding: A Retrospective Observational Study

    PubMed Central

    Dakik, Hassan K.; Srygley, F. Douglas; Chiu, Shih-Ting; Chow, Shein-Chung

    2017-01-01

    Introduction. The majority of patients with acute upper gastrointestinal bleeding (UGIB) are admitted for urgent endoscopy as it can be difficult to determine who can be safely managed as an outpatient. Our objective was to compare four clinical prediction scoring systems: Glasgow Blatchford Score (GBS) and Clinical Rockall, Adamopoulos, and Tammaro scores in a sample of patients presenting to the emergency department of a large US academic center. Methods. We performed a retrospective cohort study of patients during 2008–2010. Our outcome was significant UGIB defined as high-risk stigmata on endoscopy, or receipt of blood transfusion or surgery, or death. Results. A total of 393 patients met inclusion criteria. The GBS was the most sensitive for detecting significant UGIB at 98.30% and had the highest negative predictive value (90.00%). Adding nasogastric lavage data to the GBS increased the sensitivity to 99.57%. Conclusions. Of all four scoring systems compared, the GBS demonstrated the highest sensitivity and negative predictive value for identifying a patient with a significant UGIB. Therefore, patients with a 0 score can be safely managed as an outpatient. Our results also suggest that performing a nasogastric lavage adds little to the diagnosis UGIB. PMID:28246528

  11. Evaluation of a clinic for pregnant adolescents.

    PubMed

    Patterson, R J; Ellerbee, S; Powell, M J; Thompson, P J; Jackson, E

    1994-08-01

    A random retrospective review of the Teen Obstetrical Parenting Perinatal Services (TOPPS) clinic medical records for 1985 to 1989 was completed on 120 adolescent mothers (30 charts for each year). The purpose of this study was to evaluate maternal and infant outcomes related to the goals of the TOPPS clinic located at University Hospital on the UAMS campus in Little Rock, Arkansas. The clinic was cofounded by Lee Lee Doyle, Ph.D., who is now professor of obstetrics/gynecology at UAMS, and Betty Rouse, R.N., M.N.Sc., who is a clinical associate professor at UAMS, College of Nursing. The outcomes measured were nutritional status as measured by maternal weight gain, infant birth weight, gestational age and Apgar scores. Referrals to appropriate agencies during pregnancy were also reviewed. Analysis of the data revealed that 31% of clients received documented nutritional counseling, 60.2% of the babies were healthy (88% term and 87% appropriate for gestational age), and documented referrals (i.e. WIC, AFDC, Medicaid, etc.) were made in 32% of the cases. Conclusions were that both mothers and infants had positive outcomes. Documentation of referrals needs to be improved or rationale stated for non-referral.

  12. Reflective journaling for clinical judgment development and evaluation.

    PubMed

    Lasater, Kathie; Nielsen, Ann

    2009-01-01

    Reflective journaling is a strategy used often in clinical education to gain insight into students' clinical thinking; however, studies indicate that students may benefit from guided reflections. Numerous tools have been used to structure student reflection with varying results. This article describes the outcomes from using the Guide for Reflection based on Tanner's Clinical Judgment Model. The Lasater Clinical Judgment Rubric, created from the Model, is used to evaluate development of clinical judgment and provides language to communicate about clinical thinking with students. Senior immersion course competencies, also developed with language from Tanner's Clinical Judgment Model,offer a comprehensive package that fosters students' clinical judgment development, faculty-student communication about clinical judgment, and evaluation of students' clinical thinking.

  13. Evaluation of a clinical video telehealth pain management clinic.

    PubMed

    Desko, Lauren; Nazario, Mitchell

    2014-12-01

    The objectives of this project were to evaluate patient satisfaction with the clinical video telehealth (CVT) pain management clinic, and to evaluate possible benefits of this clinic. Data collected included the distance from the patient's home to the main Department of Veterans Affairs (VA) medical center, the distance from the patient's home to the community based outpatient clinic (CBOC), travel distance saved for the patient, and travel pay status. Following CVT clinic appointments patients were asked to complete a written feedback assessment to evaluate patient satisfaction. All data were analyzed using descriptive statistics. Veterans saved 8,981 miles in travel distance, and the VA saved $2,317.51 due to averted travel reimbursement. There was a 90% satisfaction rate with the CVT pain management clinic services, and 90% of patients agreed that they would recommend telehealth to other veterans. Overall, patients are satisfied with the CVT pain management clinic. Furthermore, the substantial miles saved for the patients, as well as the cost savings for the VA, indicates that this service has tangible benefits. As this clinic continues to operate, it can be expected that miles saved for patients and cost savings for the VA will continue to grow.

  14. Evaluation of the clinical, immunologic, and biochemical effects of nitroso sulfamethoxazole administration to dogs: a pilot study.

    PubMed

    Lavergne, Sidonie N; Volkman, Erin M; Maki, Jennifer E; Yoder, Andrea R; Trepanier, Lauren A

    2005-03-01

    Sulfonamide antimicrobials such as sulfamethoxazole (SMX) have been associated in humans with hypersensitivity reactions, to include fever, skin eruptions, hepatotoxicity, and blood dyscrasias. These reactions also occur in dogs, the only non-human species known to develop a similar spectrum of sulfonamide hypersensitivity. Sulfonamide hypersensitivity is not well understood, but has been hypothesized to be due to the generation of the reactive oxidative metabolite, nitroso sulfamethoxazole (SMX-NO). SMX-NO, unlike the parent sulfonamide, is cytotoxic in vitro, haptenizes tissue proteins, and is immunogenic in rodents. The purpose of this pilot study was to determine whether SMX-NO, when administered to dogs, would lead to drug-tissue adducts, anti-drug antibodies, antioxidant depletion, or clinical evidence of drug hypersensitivity. Four dogs were randomized to one of four treatments: SMX-NO 1 mg/kg; SMX-NO 3 mg/kg; SMX-NO 10 mg/kg; or vehicle control. Dosing was by the intraperitoneal route, once daily for four consecutive days per week, for 2 weeks total, followed by a third week of observation. Following this, all dogs were challenged with trimethoprim-sulfamethoxazole, 25 mg/kg for 12 h for 2 weeks. No dog developed clinical or biochemical evidence of drug hypersensitivity. Plasma cysteine and leukocyte reduced glutathione were not depleted during dosing; however, ascorbate was significantly depleted by week 2 following SMX-NO at 10 mg/kg. Anti-SMX antibodies (IgG or IgM by ELISA) were not detected in any dogs at any time points. SMX-hemoglobin adducts were detected in the spleen in SMX-NO dosed dogs; however, these adducts were not accompanied by an immunologic or systemic response. The results of this pilot study indicate that SMX-NO dosing in dogs, using a dosing protocol shown to be immunogenic in other species, produces modest ascorbate depletion and hemoglobin adduct formation, but is insufficient to produce an immunologic response or a clinical syndrome

  15. Evaluation and clinical significance of the stomach age model for evaluating aging of the stomach-a multicenter study in China

    PubMed Central

    2014-01-01

    Background A higher prevalence of chronic atrophic gastritis (CAG) occurs in younger adults in Asia. We used Stomach Age to examine the different mechanisms of CAG between younger adults and elderly individuals, and established a simple model of cancer risk that can be applied to CAG surveillance. Methods Stomach Age was determined by FISH examination of telomere length in stomach biopsies. Δψm was also determined by flow cytometry. Sixty volunteers were used to confirm the linear relationship between telomere length and age while 120 subjects were used to build a mathematical model by a multivariate analysis. Overall, 146 subjects were used to evaluate the validity of the model, and 1,007 subjects were used to evaluate the relationship between prognosis and Δage (calculated from the mathematical model). ROC curves were used to evaluate the relationship between prognosis and Δage and to determine the cut-off point for Δage. Results We established that a tight linear relationship between the telomere length and the age. The telomere length was obvious different between patients with and without CAG even in the same age. Δψm decreased in individuals whose Stomach Age was greater than real age, especially in younger adults. A mathematical model of Stomach Age (real age + Δage) was successfully constructed which was easy to apply in clinical work. A higher Δage was correlated with a worse outcome. The criterion of Δage >3.11 should be considered as the cut-off to select the subgroup of patients who require endoscopic surveillance. Conclusion Variation in Stomach Age between individuals of the same biological age was confirmed. Attention should be paid to those with a greater Stomach Age, especially in younger adults. The Δage in the Simple Model can be used as a criterion to select CAG patients for gastric cancer surveillance. PMID:25057261

  16. Quality of written narrative feedback and reflection in a modified mini-clinical evaluation exercise: an observational study.

    PubMed

    Pelgrim, Elisabeth A M; Kramer, Anneke W M; Mokkink, Henk G A; Van der Vleuten, Cees P M

    2012-10-18

    Research has shown that narrative feedback, (self) reflections and a plan to undertake and evaluate improvements are key factors for effective feedback on clinical performance. We investigated the quantity of narrative comments comprising feedback (by trainers), self-reflections (by trainees) and action plans (by trainer and trainee) entered on a mini-CEX form that was modified for use in general practice training and to encourage trainers and trainees to provide narrative comments. In view of the importance of specificity as an indicator of feedback quality, we additionally examined the specificity of the comments. We collected and analysed modified mini-CEX forms completed by GP trainers and trainees. Since each trainee has the same trainer for the duration of one year, we used trainer-trainee pairs as the unit of analysis. We determined for all forms the frequency of the different types of narrative comments and rated their specificity on a three-point scale: specific, moderately specific, not specific. Specificity was compared between trainee-trainer pairs. We collected 485 completed modified mini-CEX forms from 54 trainees (mean of 8.8 forms per trainee; range 1-23; SD 5.6). Trainer feedback was more frequently provided than trainee self-reflections, and action plans were very rare. The comments were generally specific, but showed large differences between trainee-trainer pairs. The frequency of self-reflection and action plans varied, all comments were generally specific and there were substantial and consistent differences between trainee-trainer pairs in the specificity of comments. We therefore conclude that feedback is not so much determined by the instrument as by the users. Interventions to improve the educational effects of the feedback procedure should therefore focus more on the users than on the instruments.

  17. Multicenter study of hyaluronic acid obtained by biotechnology to evaluate clinical efficacy and safety in knee osteoarthritis.

    PubMed

    Novaes, A C; Schaiquevich, P; Nasswetter, G

    2005-01-01

    Viscosuppplementation with intra-articular hyaluronic acid (hyaluronan [HA]) is a relatively new option for improving pain and articular function in patients with symptomatic knee osteoarthritis. An open multi-center study was performed in 365 patients with definite and symptomatic knee osteoarthritis from seven Latin American countries. Five doses of HA were administered once a week. The parameters studied were pain (six items), stiffness (two items) and functional capacity (17 items). The parameters were evaluated 1 week after the corresponding injection. Statistical differences were found when basal determinations of the three parameters were compared with the results of the first and fourth administration (p < 0.05). Intra-articular HA administration was well tolerated. Treatment-related nonserious adverse events were registered in 2.5% of administrations. Based on the results obtained, HA is a useful and well-tolerated symptomatic treatment for knee osteoarthritis with a rapid onset of action.

  18. Pilot study to evaluate the effect of topical dimethicone on clinical signs and skin barrier function in dogs with naturally occurring atopic dermatitis.

    PubMed

    Pellicoro, C; Marsella, R; Ahrens, K

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis.

  19. Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

    PubMed Central

    Pellicoro, C.; Marsella, R.; Ahrens, K.

    2013-01-01

    This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

  20. Evaluation of Anti-Inflammatory Effects of Curcumin Gel as an Adjunct to Scaling and Root Planing: A Clinical Study

    PubMed Central

    Anuradha, B R; Bai, Yendluri Durga; Sailaja, Sambhana; Sudhakar, Jaradoddi; Priyanka, M; Deepika, V

    2015-01-01

    Background: Complete removal of irritants is not possible with mechanical therapy alone. Adjunctive use of systemic administration of antibiotics results in the distribution of drug throughout the body, which can give rise to toxicity. Curcumin (diferuloylmethane), a constituent of Curcuma longa plant, which possess antioxidant, anti-inflammatory, anti-carcinogenic, anti-microbial, anti-hyper algesic and hypocholesterolemic properties. The aim of the present study is to compare the effects of the curcumin gel as an adjunct to subgingival scaling and root planning with the effect achieved using subgingival scaling and root planning alone. Materials and Methods: Thirty patients either male or female with chronic localized or generalized periodontitis aged between 25 and 60 years with pocket depth of 5-7 mm affecting at least two nonadjacent sites were included. In the experimental site scaling and root planning was performed, followed by placement of the curcumin gel and periodontal pack application. In the control site, subgingival scaling alone was performed followed by periodontal pack application. Parameters included were: Plaque index (PI), gingival index (GI), probing depth (PD) and clinical attachment loss. These parameters were recorded on day 0, 30 and 45 days. Results: Significant reduction in mean was observed in PI, GI, PD and gain in clinical attachment level were demonstrated in both the groups from baseline to 45 days. However, statistical significant reduction was observed in PI at baseline and 30th day and GI at 30th day. Conclusion: Curcumin can be effectively used along with scaling and root planning. Future research is required to determine the long-term effects of curcumin on a large sample of subjects. PMID:26229378

  1. Evaluation of SMN Protein, Transcript, and Copy Number in the Biomarkers for Spinal Muscular Atrophy (BforSMA) Clinical Study

    PubMed Central

    Crawford, Thomas O.; Paushkin, Sergey V.; Kobayashi, Dione T.; Forrest, Suzanne J.; Joyce, Cynthia L.; Finkel, Richard S.; Kaufmann, Petra; Swoboda, Kathryn J.; Tiziano, Danilo; Lomastro, Rosa; Li, Rebecca H.; Trachtenberg, Felicia L.; Plasterer, Thomas; Chen, Karen S.

    2012-01-01

    Background The universal presence of a gene (SMN2) nearly identical to the mutated SMN1 gene responsible for Spinal Muscular Atrophy (SMA) has proved an enticing incentive to therapeutics development. Early disappointments from putative SMN-enhancing agent clinical trials have increased interest in improving the assessment of SMN expression in blood as an early “biomarker” of treatment effect. Methods A cross-sectional, single visit, multi-center design assessed SMN transcript and protein in 108 SMA and 22 age and gender-matched healthy control subjects, while motor function was assessed by the Modified Hammersmith Functional Motor Scale (MHFMS). Enrollment selectively targeted a broad range of SMA subjects that would permit maximum power to distinguish the relative influence of SMN2 copy number, SMA type, present motor function, and age. Results SMN2 copy number and levels of full-length SMN2 transcripts correlated with SMA type, and like SMN protein levels, were lower in SMA subjects compared to controls. No measure of SMN expression correlated strongly with MHFMS. A key finding is that SMN2 copy number, levels of transcript and protein showed no correlation with each other. Conclusion This is a prospective study that uses the most advanced techniques of SMN transcript and protein measurement in a large selectively-recruited cohort of individuals with SMA. There is a relationship between measures of SMN expression in blood and SMA type, but not a strong correlation to motor function as measured by the MHFMS. Low SMN transcript and protein levels in the SMA subjects relative to controls suggest that these measures of SMN in accessible tissues may be amenable to an “early look” for target engagement in clinical trials of putative SMN-enhancing agents. Full length SMN transcript abundance may provide insight into the molecular mechanism of phenotypic variation as a function of SMN2 copy number. Trial Registry Clinicaltrials.gov NCT00756821 PMID:22558076

  2. Clinical evaluation of giomer- and resin-modified glass ionomer cement in class V noncarious cervical lesions: An in vivo study

    PubMed Central

    Jyothi, KN; Annapurna, S; Kumar, Anil S; Venugopal, P; Jayashankara, CM

    2011-01-01

    Objectives: To evaluate and compare the clinical performance of Giomer (Beautifil II) and RMGIC (Fuji II LC) in noncarious cervical lesions. Materials and Methods: Thirty-two subjects with one or two pairs of noncarious cervical lesions were included in the study. Each pair of lesion was restored with either giomer or RMGIC assigned randomly. Clinical evaluation of restorations was done using USPHS criteria. Data was formulated in a predesigned format and subjected to statistical analysis using the chi square test. Results: Statistically significant difference was found between RMGIC and Giomer with respect to surface roughness with P value <0.001. Conclusion: Giomer showed superior surface finish compared to RMGIC. Both Giomer and RMGIC showed equal retention ability. PMID:22144814

  3. A comparative evaluation of 4% articaine and 2% lidocaine in mandibular buccal infiltration anesthesia: A clinical study

    PubMed Central

    Maruthingal, Sunith; Mohan, Dennis; Maroli, Ramesh Kumar; Alahmari, Ali; Alqahtani, Ahmed; Alsadoon, Mohammed

    2015-01-01

    Background: To compare 4% articaine and 2% lidocaine local anesthetics in achieving pulpal anesthesia of the lower first permanent molar teeth objectively, and to assess and compare lip and lingual mucosa numbness subjectively. Materials and Methods: All subjects received 1.7 ml of any one anesthetic in the mucobuccal fold adjacent to mandibular first molar teeth; the same individuals received the second infiltration at least 1 week after the first. Later, comparisons for pulpal anesthesia, lip and lingual mucosa numbness between these two anesthetics solutions were made. Results: Articaine showed significant results with P = 0.006 in achieving pulpal anesthesia objectively, when compared with lidocaine. Articaine also showed very high significant results subjectively with P = 0.0006 in achieving lip numbness, when compared with lidocaine. But the results in achieving lingual mucosa numbness with articaine subjectively was not significant with P = 0.01, when compared with lidocaine. Conclusion: Endodontic and operative treatments are one of the most common oral non-surgical procedures done under local anesthesia. The diversity of anesthetic substances currently available on the market requires dental professionals to assess the drug both by its pharmacokinetic and also by its clinical characteristics during dental treatments. Our study used 4% articaine, which is available in the market, for comparison with 2% lidocaine. Further studies are required to use an equal concentration of solutions to achieve more accurate results. PMID:26759799

  4. An evaluation of service utilization among male to female transgender youth: qualitative study of a clinic-based sample.

    PubMed

    Corliss, Heather L; Belzer, Marvin; Forbes, Catherine; Wilson, Erin C

    2007-01-01

    This qualitative study examined experiences with health and social service institutions and experiences related to education, employment, and other social networks among 18 ethnically diverse, male to female (MTF) transgender youth aged 16 to 24 years. Participants were recruited from a youth health clinic where they were receiving services for their transgender/transsexual identity. In-depth, semi-structured interviews explored youths' patterns of service utilization, reasons for seeking care, beliefs about the usefulness of services received, experiences with service providers, barriers to care, and suggestions for improving services tailored to them. Similar to other studies with this population, participants described a multitude of health and social risk experiences as well as complex needs related to healthcare, education, employment, housing, personal relationships, and safety. Results suggest a mixed pattern of both positive and negative experiences within the medical, social and mental health services arenas. To improve support for transgender youth and assist in their positive development, it is essential to improve and expand the availability of culturally competent and effective services for this population.

  5. Clinical evaluation of 262 osseointegrated implants placed in sites grafted with calcium phosphosilicate putty: a retrospective study.

    PubMed

    Babbush, Charles A; Kanawati, Ali

    2015-02-01

    Along with the widespread use of dental implants, regenerative procedures have become an indispensable tool for implant surgeons in managing residual ridges and the surrounding bone. Putty bone grafts have significantly superior handling characteristics in comparison to particulates. These include ease of placement, enhanced particle containment, and a viscous consistency that has allowed for unique delivery systems to be developed. The aim of this study was to report the clinical efficacy of calcium phosphosilicate (CPS) putty in a wide variety of indications related to implant reconstruction and to report the survival rate of implants placed in these grafted sites. The CPS putty was used as the graft material of choice. Treatments were categorized into following groups: extraction graft, extraction with immediate implant placement, all-on-four concept, peri-implantitis treatment, bone augmentation before implant placement, implant replacement graft, and grafting around implant placed in resorbed ridges. Included in the analysis were 65 patients (36 men, 29 women) with a mean age of 63 ± 12 years. In total, 262 implants were placed. Four implants were diagnosed with peri-implantitis and were treated as described in category 4, for a total of 266 grafted sites. Two implants from the extraction graft category and 3 implants from the all-on-four group were lost and replaced with successfully osseointegrated implants during a mean study follow-up period of 12.24 ± 2.32 months. The implant success rate at 1 year was 98.1% (257/262). Based on results of this large-scale, retrospective study we conclude that (1) the use of putty bone grafts can simplify bone-grafting procedures and reduce intraoperative time in various grafting indications, (2) this study verified the efficacy of a CPS putty bone graft biomaterial in a large array of implant-related surgical indications, and (3) implants placed in sites grafted with CPS putty yield very high survival rates.

  6. A clinical study to evaluate the correlation between maxillary central incisor tooth form and face form in an Indian population.

    PubMed

    Koralakunte, Pavankumar R; Budihal, Dhanyakumar H

    2012-09-01

    A study was performed to examine the correlation between maxillary central incisor tooth form and face form in males and females in an Indian population. The selection of prosthetic teeth for edentulous patients is a primary issue in denture esthetics, especially in the case of maxillary central incisors, which are the most prominent teeth in the arch. Two hundred dental students of Indian origin comprising 79 males and 121 females aged 18-28 years studying at Bapuji Dental College and Hospital were randomly selected as the study subjects. A standardized photographic procedure was used to obtain images of the face and the maxillary central incisors. The outline forms of the face and the maxillary right central incisor tooth were determined using a standardized method. The outline forms obtained were used to classify both face form and tooth form on the basis of visual and William's methods. The means were considered after evaluation by five prosthodontists, and the results were tabulated. Statistical analysis was performed using the chi-squared test for association and Z-test for equality of proportions. A correlation greater than 50% was observed between tooth form and face form by the visual method, compared with one of 31.5% by William's method. There was no highly defined correlation between maxillary central incisor tooth form and face form among the male and female Indian subjects studied.

  7. The Physician's Assistant in a Rural Satellite Clinic: Report on an Evaluative Case Study of Utilization, Acceptance and Economics.

    ERIC Educational Resources Information Center

    Hill, Robert; And Others

    In an effort to mitigate the maldistribution of U.S. physicians, a rural satellite clinic was established in 1973 to serve the 1,239 citizens of Yale, Oklahoma. The clinic was manned by a graduate of the two year Physician's Associate program at the University of Oklahoma who was under the supervision and employ of a pediatrician located 20 miles…

  8. Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of Mouse Models and Clinical Implementation

    DTIC Science & Technology

    2007-03-01

    5 Feb 2007 4 . TITLE AND SUBTITLE 5a. CONTRACT NUMBER Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of...Page Introduction…………………………………………………………….………..….. 4 Body………………………………………………………………………………….. 5 Key Research Accomplishments...11 Appendices…………………………………………………………………………… 12 4 INTRODUCTION Women diagnosed with breast cancer today have significantly better

  9. Clinical pathways: a tool to evaluate clinical learning.

    PubMed

    Bradshaw, M J

    1999-01-01

    Clinical pathways are a means by which an instructor can objectively and effectively evaluate student learning and progress toward clinical outcomes. An advantage to use of pathways in one-time experiences is that the pathway serves as a criterion-based frame of reference for both student and instructor, since the criteria are the same as for other clinical experiences in that course. The faculty member thus has an objective measure of student learning and performance, and the student always knows the measure on which she or he will be evaluated. Clinical pathways are limited to brief experiences and are not designed to show professional growth and progress in learning over time. A pathway could be designed, however, to appraise critical thinking and professional behaviors associated with spontaneous incidents, such as a problem patient. Nurse educators can use pathways as a creative means to address student responses in a variety of situations.

  10. EVALUATION OF A COMBINATION OF A UNANI PHARMACOPEAL PREPARATION (ITRIFAL USTUKHUDOOS) WITH CLOVES (QARANFAL) IN ALLERGIC RHINITIS – A PRELIMINARY CLINICAL STUDY

    PubMed Central

    Hussain, Syed Asif; Khan, A.B.; Siddiqui, M.Y.; Latafat, T.; Kidwai, T.

    2003-01-01

    Allergic Rhinitis is typically characterized by sneezing, rhinorrhoea, nasal obstruction, nasal, conjunctival & pharyngeal itching and lacrimation all occurring in a temporal relation to allergen exposure. The peak incidence of this disease occurs in childhood and adolescence, with most of the cases belonging to the atopic category. There is a high incidence of patients of allergic rhinitis attending the outdoor sections of Ajmal Khan Tibbiya College Hospital. Many of them are dissatisfied with conventional anti-histaminic drugs. An open study was carried out on 20 such patients aged between 15 to 50 years to evaluate the clinical efficacy of a unani pharmacopeal preparation [Itrifal ustukhudoos] added with cloves [qaranfal]. Preliminary clinical study showed promising results. The study is into the next phase in which a comparative double-blind trial is being conducted with this combination and Allegra (Fexofenadine hydrochloride). PMID:22557103

  11. Clinical evaluation of vocal fold paralysis.

    PubMed

    Richardson, Brent E; Bastian, Robert W

    2004-02-01

    Vocal fold paralysis is regarded as a sign of other pathologic findings until investigation has proven that there is no lesion to explain the paralysis. We have outlined a cost-effective and time- and labor-efficient method for the clinical evaluation of vocal fold paralysis, including a focused history; vocal capability assessment to find deficits in the function of palate,pharynx, and larynx: and, finally, an intense examination under topical anesthesia to demonstrate these deficits. In essence, it is the endoscopic version of a radiographic study from the skull base through the aortic arch. This method is streamlined as compared with prior protocols for evaluation of vocal fold paralysis, because it directs the necessary further workup according to the likely site of the lesion as indicated by the extended physical examination and can be conducted entirely in the physician's office. Radiographic workup should include CT of the skull base through the upper mediastinum if solely a recurrent nerve paralysis is present; it should include MRI of the skull base if high vagal signs and symptoms are present. If MRI is negative, CT may also be needed for complete evaluation. Neurologic signs that are not all ipsilateral require MRI of the brain and consultation with a neurologist. Esophageal obstruction combined with vocal fold paralysis mandates evaluation via esophagoscopy or an esophagram.

  12. Clinical Evaluation of Specific Oral Manifestations in Pediatric Patients with Ascertained versus Potential Coeliac Disease: A Cross-Sectional Study

    PubMed Central

    Matacena, Giada; Costa, Stefano; Magazzù, Giuseppe

    2014-01-01

    Patients involved on coeliac disease (CD) have atypical symptoms and often remain undiagnosed. Specific oral manifestations are effective risk indicators of CD and for this reason an early diagnosis with a consequent better prognosis can be performed by the dentist. There are not researches analysing the frequency of these oral manifestations in potential coeliac patients. The aim of this study is to investigate the oral hard and soft tissue lesions in potential and ascertained coeliac children in comparison with healthy controls. 50 ascertained children, 21 potential coeliac patients, and 54 controls were recruited and the oral examination was performed. The overall oral lesions were more frequently present in CD patients than in controls. The prevalence of oral soft tissue lesions was 62% in ascertained coeliac, 76.2% in potential coeliac patients, and 12.96% in controls (P < 0.05). Clinical dental delayed eruption was observed in 38% of the ascertained coeliac and 42.5% of the potential coeliac versus 11.11% of the controls (P < 0.05). The prevalence of specific enamel defects (SED) was 48% in ascertained coeliac and 19% in potential coeliac versus 0% in controls (P < 0.05; OR = 3.923). The SED seem to be genetically related to the histological damage and villous atrophy. PMID:25197270

  13. Clinical Adaptation of the "Tibiofibular Line" for Intraoperative Evaluation of Open Syndesmosis Reduction Accuracy: A Cadaveric Study.

    PubMed

    Reb, Christopher W; Hyer, Christopher F; Collins, Christy L; Fidler, Corey M; Watson, B Collier; Berlet, Gregory C

    2016-11-01

    The "tibiofibular line" is a new axial computed tomography parameter for assessing syndesmosis reduction, which references the flat anterolateral surface of the fibula and anterolateral tibial tubercle. These same bony landmarks are easily visualized via a lateral approach to the fibula. This cadaveric study assessed the practical aspects of measuring the tibiofibular line intraoperatively. Three observers simulated the tibiofibular line using operative rulers in 3 measurement series utilizing 10 cadaveric specimens: intact syndesmosis, syndesmosis reduction, and fixation after application of lateral plate and screws to the fibula, and post syndesmosis reduction and fixation without plate and screws. The majority (78%) of clinical tibiofibular line measurements were within the "normal" range (0-2 mm). However, there was a general trend toward malreduction (>2 mm) across measurement series. Intraobserver variability ranged from poor to excellent (intraclass correlation range, 0.12-0.85, Fleiss kappa range, 0.19-0.40) and interobserver reliability was only generally in the fair range (intraclass correlation range, 0.49-0.61; Fleiss kappa range, 0.19-0.40). Taken as a whole, these findings found that the technique was feasible but clearly indicated that further refinement of this protocol, including the use of computed tomography, would be needed to determine if better control of confounding variables would reveal better observer reliability. The CT-based TFL technique for syndesmosis reduction assessment could not reliably be translated into an intraoperative open technique because of the confounding effects of subjectivity and operator error. © The Author(s) 2016.

  14. Clinical evaluation and serum concentration of zuclopenthixol acetate in psychotic Asian patients: a single-dose preliminary study.

    PubMed

    Tan, C H; Low, B L; Ng, L L; Khoo, Y M; Lee, H S

    1993-04-01

    Nineteen acutely disturbed psychotic Asian patients were treated with a single intramuscular injection of 50 mg of zuclopenthixol acetate in Viscoleo. Patients were assessed clinically before and after treatment using the Brief Psychiatric Rating Scale (BPRS). Serum zuclopenthixol and the inactive geometric isomer trans(E)-clopenthixol were determined by high-performance liquid chromatography after intramuscular injection. All patients improved, with the BPRS being significantly reduced (p < 0.001) at 72 h after injection. Adverse effects were generally few. The mean +/- SEM serum zuclopenthixol concentrations at 24, 48, and 72 h were 19.9 +/- 2.8, 31.5 +/- 4.5, and 17.8 +/- 2.9 micrograms/L, respectively. trans(E)-Clopenthixol concentrations ranged from negligible to 39.5 micrograms/L. This study confirms that a single intramuscular injection of 50 mg is adequate for managing severely disturbed psychotic patients for the first 3 days. The serum zuclopenthixol concentrations attained in the Asian patients were higher than those reported in Caucasian psychiatric patients. In some patients, a considerable amount of zuclopenthixol had been transformed to trans(E)-clopenthixol.

  15. Evaluation of the Tobacco Heating System 2.2. Part 8: 5-Day randomized reduced exposure clinical study in Poland.

    PubMed

    Haziza, Christelle; de La Bourdonnaye, Guillaume; Skiada, Dimitra; Ancerewicz, Jacek; Baker, Gizelle; Picavet, Patrick; Lüdicke, Frank

    2016-11-30

    The Tobacco Heating System (THS) 2.2, a candidate Modified Risk Tobacco Product (MRTP), is designed to heat tobacco without burning it. Tobacco is heated in order to reduce the formation of harmful and potentially harmful constituents (HPHC), and reduce the consequent exposure, compared with combustible cigarettes (CC). In this 5-day exposure, controlled, parallel-group, open-label clinical study, 160 smoking, healthy subjects were randomized to three groups and asked to: (1) switch from CCs to THS 2.2 (THS group; 80 participants); (2) continue to use their own non-menthol CC brand (CC group; 41 participants); or (3) to refrain from smoking (smoking abstinence (SA) group; 39 participants). Biomarkers of exposure, except those associated with nicotine exposure, were significantly reduced in the THS group compared with the CC group, and approached the levels observed in the SA group. Increased product consumption and total puff volume were reported in the THS group. However, exposure to nicotine was similar to CC at the end of the confinement period. Reduction in urge-to-smoke was comparable between the THS and CC groups and THS 2.2 product was well tolerated. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  16. Important factors in predicting mortality outcome from stroke: findings from the Anglia Stroke Clinical Network Evaluation Study

    PubMed Central

    O. Bachmann, Max; Loke, Yoon Kong; D. Musgrave, Stanley; Price, Gill M.; Hale, Rachel; Metcalf, Anthony Kneale; Turner, David A.; Day, Diana J.; A. Warburton, Elizabeth; Potter, John F.

    2017-01-01

    Abstract Background although variation in stroke service provision and outcomes have been previously investigated, it is less well known what service characteristics are associated with reduced short- and medium-term mortality. Methods data from a prospective multicentre study (2009–12) in eight acute regional NHS trusts with a catchment population of about 2.6 million were used to examine the prognostic value of patient-related factors and service characteristics on stroke mortality outcome at 7, 30 and 365 days post stroke, and time to death within 1 year. Results a total of 2,388 acute stroke patients (mean (standard deviation) 76.9 (12.7) years; 47.3% men, 87% ischaemic stroke) were included in the study. Among patients characteristics examined increasing age, haemorrhagic stroke, total anterior circulation stroke type, higher prestroke frailty, history of hypertension and ischaemic heart disease and admission hyperglycaemia predicted 1-year mortality. Additional inclusion of stroke service characteristics controlling for patient and service level characteristics showed varying prognostic impact of service characteristics on stroke mortality over the disease course during first year after stroke at different time points. The most consistent finding was the benefit of higher nursing levels; an increase in one trained nurses per 10 beds was associated with reductions in 30-day mortality of 11–28% (P < 0.0001) and in 1-year mortality of 8–12% (P < 0.001). Conclusions there appears to be consistent and robust evidence of direct clinical benefit on mortality up to 1 year after acute stroke of higher numbers of trained nursing staff over and above that of other recognised mortality risk factors. PMID:28181626

  17. Comparative evaluation of efficacy of self-ligating interactive bracket with conventional preadjusted bracket: A clinical study

    PubMed Central

    Jayachandran, Balajee; Padmanabhan, Ratna; Vijayalakshmi, Devaki; Padmanabhan, Janardhanam

    2016-01-01

    Aims and Objectives: This clinical study was conducted to compare the interactive self-ligating twin brackets and the standard double width brackets for their efficiency in Rate of Retraction. Materials and Methods: A total of 20 patients with Angle's class I or class II or class III dento-alveolar malocclusions between the age group of 18-25 years were selected. 10 patients in each group both males and females were randomly selected for the study. Ten patients were bonded using conventional brackets (Group I) the other ten patients were bonded using Interactive self-ligating brackets (Group II). The Rate of retraction was quantified using the scanned models. Pretreatment and post treatment models were taken and scanned to measure the amount of Incisor movement and Anchor loss. Results: (1) Interactive Self-ligating brackets showed significant Rate of retraction when compared with conventional brackets on right and left quadrant. (Group I 0.545 ± .205: Group II 0.827 ± .208 P = .013*) (Group I 0.598 ± .160: Group II 0.804 ± .268 P = .071) (2) Interactive self-ligating brackets when compared with conventional brackets had significant amount of incisor movement on right and left quadrant. (Group I 3.51 ± .548: Group II 4.38 ± .1.06 P = .047*) and (Group I 3.66 ± .899: Group II 4.67 ± 1.02 P = .047*) (3) Conventional brackets showed significant Amount of Anchor loss when compared with that of Interactive self-ligating brackets on right and left quadrant. (Group I .948 ± .392: Group II 0.501 ± .229 P = .013*). In the left side (Group I 0.861 ± .464: Group II 0.498 ± .227 P = .060). Conclusion: The interactive self-ligating brackets show more efficiency in Rate of Retraction, Amount of Incisor movement and Amount of Anchor loss when compared with the conventional brackets. PMID:27307660

  18. Nursing students' experiences of the clinical learning environment in nursing homes: a questionnaire study using the CLES+T evaluation scale.

    PubMed

    Carlson, Elisabeth; Idvall, Ewa

    2014-07-01

    One major challenge facing the health care systems worldwide is the growing demand for registered nurses able to provide qualified nursing care for a vulnerable population. Positive learning experiences during clinical practice influence not only learning outcomes, but also how students reason in relation to future career choices. To investigate student nurses' experiences of the clinical learning environment during clinical practice in nursing homes, and to compare perceptions among student nurses with or without prior work experience as health care assistants in elderly care. A cross-sectional study was designed, utilising the Swedish version of the CLES+T evaluation scale. 260 student nurses (response rate 76%) who had completed a five week long clinical placement in nursing homes returned the questionnaire during the data collection period in 2011-2012. Data were analysed using descriptive statistics. Mann-Whitney U-test was used to examine differences in relation to students with or without prior experience of elderly care. Overall, the clinical learning environment was evaluated in a predominantly positive way. The sub-dimension Supervisory relationship displayed the highest mean value, and the lowest score was calculated for the sub-dimension Leadership style of the ward manager. Statistical significant differences between sub-groups were displayed for four out of 34 items. The supervisory relationship had the greatest impact on how student nurses experienced the clinical learning environment in nursing homes. It is therefore, of utmost importance that collaborative activities, between educational and nursing home settings, supporting the work of preceptors are established and maintained. Copyright © 2014 Elsevier Ltd. All rights reserved.

  19. Clinical evaluation of glass ceramic inlays (Dicor).

    PubMed

    Stenberg, R; Matsson, L

    1993-04-01

    The purpose of the study was to evaluate the clinical behavior of ceramic class-II inlays (Dicor) in the first 2 years after placement. As a reference, a similar number of dental amalgam restorations were followed up during the same period. Twenty-five inlays and 25 dental amalgams were placed on premolars and first molars of 20 and 19 patients (15-19 years old), respectively. The inlay preparations were made in accordance with the manufacturer's recommendations, and the inlays were produced by a licensed Dicor laboratory. The inlays were luted, using a glass ionomer cement. The dental amalgam preparations were made using standard class-II preparation techniques and filled with ANA 2000. The inlays were evaluated after 6, 12, and 24 months, and the dental amalgam restorations after 24 months, using the criteria suggested by Ryge. In addition, the 24-month examination included proximal recording of dental plaque and gingivitis. With the exception of two inlays that fractured during the observation period, all ceramic inlays showed excellent ratings for anatomic form, marginal discoloration, and marginal caries at all examinations. Two inlays showed minor marginal defects but were classified within the range of acceptance with no need for replacement. The two fractured inlays were replacements of earlier fractured dental amalgams. The clinical behavior of the dental amalgam restorations was in most respects similar to that of the ceramic inlays. Unlike the inlays, however, no dental amalgams fractured during the observation period.(ABSTRACT TRUNCATED AT 250 WORDS)

  20. Clinical evaluation incorporating a personal genome

    PubMed Central

    Ashley, Euan A.; Butte, Atul J.; Wheeler, Matthew T.; Chen, Rong; Klein, Teri E.; Dewey, Frederick E.; Dudley, Joel T.; Ormond, Kelly E.; Pavlovic, Aleksandra; Hudgins, Louanne; Gong, Li; Hodges, Laura M.; Berlin, Dorit S.; Thorn, Caroline F.; Sangkuhl, Katrin; Hebert, Joan M.; Woon, Mark; Sagreiya, Hersh; Whaley, Ryan; Morgan, Alexander A.; Pushkarev, Dmitry; Neff, Norma F; Knowles, Joshua W.; Chou, Mike; Thakuria, Joseph; Rosenbaum, Abraham; Zaranek, Alexander Wait; Church, George; Greely, Henry T.; Quake, Stephen R.; Altman, Russ B.

    2010-01-01

    Background The cost of genomic information has fallen steeply but the path to clinical translation of risk estimates for common variants found in genome wide association studies remains unclear. Since the speed and cost of sequencing complete genomes is rapidly declining, more comprehensive means of analyzing these data in concert with rare variants for genetic risk assessment and individualisation of therapy are required. Here, we present the first integrated analysis of a complete human genome in a clinical context. Methods An individual with a family history of vascular disease and early sudden death was evaluated. Clinical assessment included risk prediction for coronary artery disease, screening for causes of sudden cardiac death, and genetic counselling. Genetic analysis included the development of novel methods for the integration of whole genome sequence data including 2.6 million single nucleotide polymorphisms and 752 copy number variations. The algorithm focused on predicting genetic risk of genes associated with known Mendelian disease, recognised drug responses, and pathogenicity for novel variants. In addition, since integration of risk ratios derived from case control studies is challenging, we estimated posterior probabilities from age and sex appropriate prior probability and likelihood ratios derived for each genotype. In addition, we developed a visualisation approach to account for gene-environment interactions and conditionally dependent risks. Findings We found increased genetic risk for myocardial infarction, type II diabetes and certain cancers. Rare variants in LPA are consistent with the family history of coronary artery disease. Pharmacogenomic analysis suggested a positive response to lipid lowering therapy, likely clopidogrel resistance, and a low initial dosing requirement for warfarin. Many variants of uncertain significance were reported. Interpretation Although challenges remain, our results suggest that whole genome sequencing can

  1. Criterion Referenced Measures for Clinical Evaluations.

    ERIC Educational Resources Information Center

    Pikulski, John J.

    This paper discusses criterion referenced tests' characteristics and their use in clinical evaluation. The distinction between diagnostic tests and criterion referenced measures is largely a matter of emphasis. Some authorities believe that in diagnostic testing the emphasis is upon an evaluation of an individual's strengths and weaknesses in…

  2. A Clinical Evaluation System for Anesthesiology Residents.

    ERIC Educational Resources Information Center

    Viets, J. L.; Foster, Scot D.

    1988-01-01

    Baylor College of Medicine's system for evaluating the clinical progress of anesthesiology residents, developed in response to problems of standards, staff cooperation, and student dissatisfaction with evaluation, assesses resident progress in terms of performance levels based on case complexity and degree of staff intervention. (Author/MSE)

  3. A Clinical Evaluation System for Anesthesiology Residents.

    ERIC Educational Resources Information Center

    Viets, J. L.; Foster, Scot D.

    1988-01-01

    Baylor College of Medicine's system for evaluating the clinical progress of anesthesiology residents, developed in response to problems of standards, staff cooperation, and student dissatisfaction with evaluation, assesses resident progress in terms of performance levels based on case complexity and degree of staff intervention. (Author/MSE)

  4. Evaluation of Novel Glass Fiber-reinforced Composite Technique for Primary Anterior Teeth with Deep Carious Lesions: A 12-month Clinical Study.

    PubMed

    Sawant, Ajinkya; Chunawalla, Yusuf; Morawala, Abdul; S Kanchan, Nupur; Jain, Kapil; Talathi, Rohan

    2017-01-01

    Early childhood caries discloses a distinct clinical pattern, and the teeth most often involved are the maxillary central incisors, lateral incisors, and the maxillary and man-dibular first molars. The maxillary incisors are most severely affected, with deep carious lesions usually involving the pulp. Teeth that have been endodontically treated often have little coronal tooth tissue remaining and as such require a post to retain the core and restoration .This study evaluated and compared the efficacy of EverStick glass fiber-reinforced composite post with ParaPost Taper Lux in primary maxillary anterior teeth. An in vivo study was conducted to evaluate and compare the longevity and failures of two fiber post systems in primary maxillary anterior teeth. A total of 60 severely mutilated primary maxillary anterior teeth from children aged 3 to 5 years were selected according to the inclusion criteria. These teeth were treated endodontically and were randomly assigned into two groups with 30 samples in each group, group I: EverStick glass fiber-reinforced composite post, group II: ParaPost Taper Lux post. The evaluation of dislodgment of posts, secondary caries, root fracture, and post fracture was carried out clinically and radiographically during every follow-up at 3, 6, 9, and 12 months interval. Statistical tests (Chi-square test, Fisher's exact probability test) suggested that dislodgment of the posts was significant between the two groups at 6, 9, and 12 months follow-ups. But within the group during subsequent follow-up intervals, dislodgment of posts as a mode of failure was not statistically significant. However, clinically failures were seen in both the study groups. Fiber post system has proved to be successful clinically in both primary and permanent teeth due to the mono-block effect with luting agent, post system, core material, and bonding to dentin. Thus, today the EverStick glass fiber post system provides a novel way of fabricating cost-effective and

  5. Evaluation of Novel Glass Fiber-reinforced Composite Technique for Primary Anterior Teeth with Deep Carious Lesions: A 12-month Clinical Study

    PubMed Central

    Sawant, Ajinkya; Chunawalla, Yusuf; Morawala, Abdul; Jain, Kapil; Talathi, Rohan

    2017-01-01

    Background Early childhood caries discloses a distinct clinical pattern, and the teeth most often involved are the maxillary central incisors, lateral incisors, and the maxillary and man-dibular first molars. The maxillary incisors are most severely affected, with deep carious lesions usually involving the pulp. Teeth that have been endodontically treated often have little coronal tooth tissue remaining and as such require a post to retain the core and restoration .This study evaluated and compared the efficacy of EverStick glass fiber-reinforced composite post with ParaPost Taper Lux in primary maxillary anterior teeth. Aim An in vivo study was conducted to evaluate and compare the longevity and failures of two fiber post systems in primary maxillary anterior teeth. Materials and methods A total of 60 severely mutilated primary maxillary anterior teeth from children aged 3 to 5 years were selected according to the inclusion criteria. These teeth were treated endodontically and were randomly assigned into two groups with 30 samples in each group, group I: EverStick glass fiber-reinforced composite post, group II: ParaPost Taper Lux post. The evaluation of dislodgment of posts, secondary caries, root fracture, and post fracture was carried out clinically and radiographically during every follow-up at 3, 6, 9, and 12 months interval. Results Statistical tests (Chi-square test, Fisher’s exact probability test) suggested that dislodgment of the posts was significant between the two groups at 6, 9, and 12 months follow-ups. But within the group during subsequent follow-up intervals, dislodgment of posts as a mode of failure was not statistically significant. However, clinically failures were seen in both the study groups. Conclusion Fiber post system has proved to be successful clinically in both primary and permanent teeth due to the mono-block effect with luting agent, post system, core material, and bonding to dentin. Thus, today the EverStick glass fiber post

  6. Evaluating impact of clinical guidelines using a realist evaluation framework.

    PubMed

    Reddy, Sandeep; Wakerman, John; Westhorp, Gill; Herring, Sally

    2015-12-01

    The Remote Primary Health Care Manuals (RPHCM) project team manages the development and publication of clinical protocols and procedures for primary care clinicians practicing in remote Australia. The Central Australian Rural Practitioners Association Standard Treatment Manual, the flagship manual of the RPHCM suite, has been evaluated for accessibility and acceptability in remote clinics three times in its 20-year history. These evaluations did not consider a theory-based framework or a programme theory, resulting in some limitations with the evaluation findings. With the RPHCM having an aim of enabling evidence-based practice in remote clinics and anecdotally reported to do so, testing this empirically for the full suite is vital for both stakeholders and future editions of the RPHCM. The project team utilized a realist evaluation framework to assess how, why and for what the RPHCM were being used by remote practitioners. A theory regarding the circumstances in which the manuals have and have not enabled evidence-based practice in the remote clinical context was tested. The project assessed this theory for all the manuals in the RPHCM suite, across government and aboriginal community-controlled clinics, in three regions of Australia. Implementing a realist evaluation framework to generate robust findings in this context has required innovation in the evaluation design and adaptation by researchers. This article captures the RPHCM team's experience in designing this evaluation. © 2015 John Wiley & Sons, Ltd.

  7. Evaluation of computer-assisted jaw reconstruction with free vascularized fibular flap compared to conventional surgery: a clinical pilot study.

    PubMed

    Modabber, Ali; Legros, Christina; Rana, Majeed; Gerressen, Marcus; Riediger, Dieter; Ghassemi, Alireza

    2012-06-01

    The introduction of computer-assisted surgery was a milestone in functional reconstructions of facial skeletal defects. We compared five computer-assisted and five conventional reconstructions with fibular grafts in the course of a pilot study. A rapid prototyping guide translated the computer-assisted surgery plan into intraoperative utilizable models. We intraoperatively measured the time needed for shaping the graft to the recipient site and the ischaemic time. Furthermore, the size of donor site defect compared to the required transplant length was evaluated. Shaping procedure and ischaemic time turned out significantly shorter when compared to conventional surgery without cutting guide (p = 0.014). Using surgical guides, there was no change between the defect size of the fibula and the necessary transplant size. In conventional surgery, a mean change of 1.92 cm occurred (p = 0.001). The surgical guide significantly reduced shaping time and consequently ischaemic time. These factors can influence flap survival. The fibular donor site defect was downsized. Copyright © 2011 John Wiley & Sons, Ltd.

  8. Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study

    PubMed Central

    Ambiye, Vijay R.; Dongre, Swati; Aptikar, Pradnya; Kulkarni, Madhura; Dongre, Atul

    2013-01-01

    Ashwagandha (Withania somnifera) has been described in traditional Indian Ayurvedic medicine as an aphrodisiac that can be used to treat male sexual dysfunction and infertility. This pilot study was conducted to evaluate the spermatogenic activity of Ashwagandha root extract in oligospermic patients. Forty-six male patients with oligospermia (sperm count < 20 million/mL semen) were enrolled and randomized either to treatment (n = 21) with a full-spectrum root extract of Ashwagandha (675 mg/d in three doses for 90 days) or to placebo (n = 25) in the same protocol. Semen parameters and serum hormone levels were estimated at the end of 90-day treatment. There was a 167% increase in sperm count (9.59 ± 4.37 × 106/mL to 25.61 ± 8.6 × 106/mL; P < 0.0001), 53% increase in semen volume (1.74 ± 0.58 mL to 2.76 ± 0.60 mL; P < 0.0001), and 57% increase in sperm motility (18.62 ± 6.11% to 29.19 ± 6.31%; P < 0.0001) on day 90 from baseline. The improvement in these parameters was minimal in the placebo-treated group. Furthermore, a significantly greater improvement and regulation were observed in serum hormone levels with the Ashwagandha treatment as compared to the placebo. The present study adds to the evidence on the therapeutic value of Ashwagandha (Withania somnifera), as attributed in Ayurveda for the treatment of oligospermia leading to infertility. PMID:24371462

  9. Clinical Evaluation of the Spermatogenic Activity of the Root Extract of Ashwagandha (Withania somnifera) in Oligospermic Males: A Pilot Study.

    PubMed

    Ambiye, Vijay R; Langade, Deepak; Dongre, Swati; Aptikar, Pradnya; Kulkarni, Madhura; Dongre, Atul

    2013-01-01

    Ashwagandha (Withania somnifera) has been described in traditional Indian Ayurvedic medicine as an aphrodisiac that can be used to treat male sexual dysfunction and infertility. This pilot study was conducted to evaluate the spermatogenic activity of Ashwagandha root extract in oligospermic patients. Forty-six male patients with oligospermia (sperm count < 20 million/mL semen) were enrolled and randomized either to treatment (n = 21) with a full-spectrum root extract of Ashwagandha (675 mg/d in three doses for 90 days) or to placebo (n = 25) in the same protocol. Semen parameters and serum hormone levels were estimated at the end of 90-day treatment. There was a 167% increase in sperm count (9.59 ± 4.37 × 10(6)/mL to 25.61 ± 8.6 × 10(6)/mL; P < 0.0001), 53% increase in semen volume (1.74 ± 0.58 mL to 2.76 ± 0.60 mL; P < 0.0001), and 57% increase in sperm motility (18.62 ± 6.11% to 29.19 ± 6.31%; P < 0.0001) on day 90 from baseline. The improvement in these parameters was minimal in the placebo-treated group. Furthermore, a significantly greater improvement and regulation were observed in serum hormone levels with the Ashwagandha treatment as compared to the placebo. The present study adds to the evidence on the therapeutic value of Ashwagandha (Withania somnifera), as attributed in Ayurveda for the treatment of oligospermia leading to infertility.

  10. Peri-implant bone loss clinical and radiographic evaluation around rough neck and microthread implants: a 5-year study.

    PubMed

    Calvo-Guirado, José Luis; López-López, Patricia J; Pérez-Albacete Martínez, Carlos; Javed, Fawad; Granero-Marín, José Manuel; Maté Sánchez de Val, José Eduardo; Ramírez Fernández, Maria Piedad

    2016-01-07

    To evaluate marginal bone loss over 5 years around microthreaded implants placed in the maxillary anterior/esthetic zone and immediate restored with non-occlusal loading. Seventy-one implants (with microthreads up to the platform-rough surface body and neck, internal connection and platform switching) were placed in healed bone in the maxillary arches of 30 men and 23 women (mean age 37.85 ± 7.09 years, range 27-60). All subjects had at least 3 mm of soft tissue to allow the establishment of adequate biologic width and to reduce bone resorption. Each patient received a provisional restoration immediately after implant placement with slight occlusal contact. Mesial and distal bone height was evaluated using digital radiography on the day following implant placement (baseline) and after 1, 2, 3, 4 and 5 years. Primary stability was measured with resonance frequency analysis. No implants failed, resulting in a cumulative survival rate of 100% after 3 years. Marginal bone loss from implant collar to bone crest measured at baseline (peri-implant bone defect at the fresh extraction socket) and after 5 years was 0.90 mm ± 0.26 mm. Mesial and distal site crestal bone loss ranged from 3.42 ± 1.2 mm at baseline to 3.51 ± 1.5 mm after 5 years and from 3.38 ± 0.9 mm at baseline to 3.49 ± 0.9 mm after 5 years, respectively (P = 0.086). The results of this study showed limited implant crestal bone loss 0.90 mm ± 0.26 mm and 100% of implant survival rate at 5-year follow-up of immediate restored implants with rough surface neck and microthreads. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  11. An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness.

    PubMed

    Barlow, Jane; Sembi, Sukhdev; Gardner, Frances; Macdonald, Geraldine; Petrou, Stavros; Parsons, Helen; Harnett, Paul; Dawe, Sharon

    2013-07-11

    Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant's physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents.An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent-infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby's development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems. The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention.The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care.The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and infant/toddler socio

  12. An evaluation of the parents under pressure programme: a study protocol for an RCT into its clinical and cost effectiveness

    PubMed Central

    2013-01-01

    Background Many babies in the UK are born to drug-dependent parents, and dependence on psychoactive drugs during the postnatal period is associated with high rates of child maltreatment, with around a quarter of these children being subject to a child protection plan. Parents who are dependent on psychoactive drugs are at risk of a wide range of parenting problems, and studies have found reduced sensitivity and responsiveness to both the infant’s physical and emotional needs. The poor outcomes that are associated with such drug dependency appear to be linked to the multiple difficulties experienced by such parents. An increase in understanding about the crucial importance of early relationships for infant well-being has led to a focus on the development and delivery of services that are aimed at supporting parenting and parent–infant interactions. The Parents under Pressure (PuP) programme is aimed at supporting parents who are dependent on psychoactive drugs or alcohol by providing them with methods of managing their emotional regulation, and of supporting their new baby’s development. An evaluation of the PuP programme in Australia with parents on methadone maintenance of children aged 3 to 8 years found significant reductions in child abuse potential, rigid parenting attitudes and child behaviour problems. Methods/design The study comprises a multicentre randomised controlled trial using a mixed-methods approach to data collection and analysis in order to identify which families are most able to benefit from this intervention. The study is being conducted in six family centres across the UK, and targets primary caregivers of children less than 2.5 years of age who are substance dependent. Consenting participants are randomly allocated to either the 20-week PuP programme or to standard care. The primary outcome is child abuse potential, and secondary outcomes include substance use, parental mental health and emotional regulation, parenting stress, and

  13. The presence of nonthoracic distracting injuries does not affect the initial clinical examination of the cervical spine in evaluable blunt trauma patients: a prospective observational study.

    PubMed

    Konstantinidis, Agathoklis; Plurad, David; Barmparas, Galinos; Inaba, Kenji; Lam, Lydia; Bukur, Marko; Branco, Bernardino C; Demetriades, Demetrios

    2011-09-01

    A distracting injury mandates cervical spine (c-spine) imaging in the evaluable blunt trauma patient who demonstrates no pain or tenderness over the c-spine. The purpose of this study was to examine which distracting injuries can negatively affect the sensitivity of the standard clinical examination of the c-spine. This is a prospective observational study conducted at a Level I Trauma Center from January 1, 2008, to December 31, 2009. After institutional review board approval, all evaluable (Glasgow Coma Scale score ≥13) blunt trauma patients older than 16 years sustaining a c-spine injury were enrolled. A distracting injury was defined as any immediately evident bony or soft tissue injury or a complaint of non-c-spine pain whether or not an actual injury was subsequently diagnosed. Information regarding the initial clinical examination and the presence of a distracting injury was collected from the senior resident or attending trauma surgeon involved in the initial management. During the study period, 101 evaluable patients sustained a c-spine injury. Distracting injuries were present in 88 patients (87.1%). The most common was rib fracture (21.6%), followed by lower extremity fracture (20.5%) and upper extremity fracture (12.5%). Only four (4.0%) patients had no pain or tenderness on the initial examination of the c-spine. All four patients had bruising and tenderness to the upper anterior chest. None of these four patients developed neurologic sequelae or required a surgical stabilization or immobilization. C-spine imaging may not be required in the evaluable blunt trauma patient despite distracting injuries in any body regions that do not involve the upper chest. Further definition of distracting injuries is mandated to avoid unnecessary utilization of resources and to reduce the imaging burden associated with the evaluation of the c-spine.

  14. Clinical evaluation of terconazole. United states experience.

    PubMed

    Thomason, J L

    1989-08-01

    Terconazole is the first of a new class of antifungal agents, the triazoles. The results of numerous European studies have demonstrated the efficacy and safety of this agent in both cream and suppository form in the treatment of vulvovaginal candidiasis. Recently, results of short- and long-term analyses in the United States confirmed the efficacy and safety of 0.4% terconazole cream and 80-mg terconazole suppositories. In short-term evaluations (eight to ten days after therapy), 0.4% terconazole cream was as effective as 2.0% miconazole nitrate cream and significantly superior microbiologically in one study. The clinical cure rates with terconazole cream ranged from 87.3% to 95.5% and the microbiologic cure rates, from 76.9% to 91.1%. Thirty- to 35-day microbiologic relapse rates with terconazole cream ranged from 10.4% to 22.2%. In the short-term evaluations of vaginal suppositories the cure rates of 80-mg terconazole suppositories for three days were comparable to those of 100-mg miconazole nitrate suppositories for seven days. The clinical cure rates with 80-mg terconazole suppositories ranged from 90.0% to 92.2% and the microbiologic cure rates, from 80.4% to 85.0%. The 30- to 35-day microbiologic relapse rates of the 80-mg terconazole suppositories ranged from 20.0% to 28.1%. Terconazole cream and suppositories demonstrated an excellent safety profile in all the studies; no life-threatening side effects occurred with any of the regimens. The frequency of common side effects was similar with terconazole and miconazole nitrate formulations.

  15. Clinical efficacy and safety evaluation of tailoring iron chelation practice in thalassaemia patients from Asia-Pacific: a subanalysis of the EPIC study of deferasirox.

    PubMed

    Viprakasit, Vip; Ibrahim, Hishamshah; Ha, Shau-Yin; Ho, Phoebe Joy; Li, Chi-Kong; Chan, Lee-Lee; Chiu, Chang-Fang; Sutcharitchan, Pranee; Habr, Dany; Domokos, Gabor; Roubert, Bernard; Xue, Hong-Ling; Bowden, Donald K; Lin, Kai-Hsin

    2011-03-01

    Although thalassaemia is highly prevalent in the Asia-Pacific region, clinical data on efficacy and safety profiles of deferasirox in patients from this region are rather limited. Recently, data from the multicentre Evaluation of Patients' Iron Chelation with Exjade (EPIC) study in 1744 patients with different anaemias has provided an opportunity to analyse 1115 thalassaemia patients, of whom 444 patients were from five countries in the Asia-Pacific region (AP) for whom thalassaemia management and choice of iron chelators were similar. Compared to the rest of the world (ROW), baseline clinical data showed that the AP group appeared to be more loaded with iron (3745.0 vs. 2822.0 ng/ml) and had a higher proportion on deferoxamine monotherapy prior to the study (82.9 vs. 58.9%). Using a starting deferasirox dose based on transfusional iron intake and tailoring it to individual patient response, clinical efficacy based on serum ferritin reduction in AP and ROW thalassaemia patients was similar. Interestingly, the AP group developed a higher incidence of drug-related skin rash compared to ROW (18.0 vs. 7.2%), which may indicate different pharmacogenetic backgrounds in the two populations. Our analysis confirms that, with appropriate adjustment of dose, deferasirox can be clinically effective across different regions, with manageable side effects.

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

    PubMed

    East, Leah; Hutchinson, Marie

    2015-12-01

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

  17. [Complications of surgical wisdom tooth removal of the maxilla. A clinical and roentgenologic study of 1,013 patients with statistical evaluation].

    PubMed

    Wächter, R; Stoll, P

    1995-01-01

    In a retrospective study the condition of the alveolar process in the region of the maxillary tuberosity after operative removal of impacted upper third molars was evaluated. Basically the clinical records of 1013 patients were explored. 371 patients were checked clinically, from 355 patients X-ray examinations were taken. There was at least one year between operation and follow-up examination. Pain was the reason for removal of the upper wisdom teeth in 32.9% of the patients. The most common intraoperative complications were oro-antral fistulae (11.3%). Most of the patients 70.9%) showed regular wound healing. Postoperative complications were seen more often and for a longer period in young female patients. In most cases (87.7%) there was a complete bony regeneration of the alveolar process in the area of the maxillary tuberosity. Contrary to our expectations cyst formations were very rare (0.59%).

  18. A study of familial MELAS: evaluation of A3243G mutation, clinical phenotype, and magnetic resonance spectroscopy-monitored progression.

    PubMed

    Chen, Chunnuan; Xiong, Nian; Wang, Yuhui; Xiong, Jing; Huang, Jinsha; Zhang, Zhentao; Wang, Tao

    2012-01-01

    The clinical manifestations of mitochondrial myopathy, encephalopathy, lactic acidosis, and stroke-like episodes syndrome (MELAS syndrome) are nonspecific and can easily be misdiagnosed. Magnetic resonance spectroscopy (MRS)-based detection of lactate in the brain has been found to be of diagnostic help in MELAS syndrome, however, the issue of whether MRS features vary by stage remains unresolved. We assessed the causative mutation and radiological features of a family of MELAS. Four of the family members harbored the A3243G mutation, probably of maternal inheritance. However, the clinical phenotypic expression was different in these patients. MRS showed a lactate peak, decreased N-acetylaspartate, choline, and creatine, which became more pronounced with progression of the disease, demonstrating that brain-MRS-based detection of lactate may be a suitable way to monitor the progression and treatment of MELAS.

  19. [Treatment evaluation and clinical decision making using HKT-30-ROM].

    PubMed

    Ter Horst, P; van Ham, M; Spreen, M; Bogaerts, S

    2014-01-01

    By means of repeated, well-supported measurements of clinical dynamic indicators from the Historical, Clinical and Future - 30 (HKT-30) it is possible to monitor behavioural changes on the basis of risks and needs. The addition of extra score parameters allows us to distinguish client-specific risks and needs. In treatment evaluation it is important to visualise changes in these indicators of treatment evaluation because they are the key to the clinical decision-making process that determines further treatment and rehabilitation. To investigate whether HKT-30 indicators can be used to measure and visualise behavioral changes for the purpose of treatment evaluation. A case study is used to illustrate how clinicians at the Forensic Psychiatric Clinic (FPK), De Woenselse Poort, ascertain risks, needs and changes and clarify these factors for the purpose of treatment evaluation and clinical decision-making. Routine treatment evaluation aided by visualised clinical HKT-30 indicators give the treatment team and the client a clearer picture of the behavioral changes for which the forensic treatment was prescribed. This evaluation provides significant starting-points for clinical decision making. Routine treatment evaluation along with a suitably adjusted HKT-30 make behavioural changes visible, render clinical decisions more transparent and provide valuable starting-points for a dialogue with the client about his treatment.

  20. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART).

    PubMed

    Mata, Nelva; Alonso, Rodrigo; Badimón, Lina; Padró, Teresa; Fuentes, Francisco; Muñiz, Ovidio; Perez-Jiménez, Francisco; López-Miranda, José; Díaz, Jose L; Vidal, Jose I; Barba, A; Piedecausa, Mar; Sanchez, Juan F; Irigoyen, Luis; Guallar, Eliseo; Ordovas, José M; Mata, Pedro

    2011-06-10

    Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (LLT) in FH patients recruited in SAFEHEART. A cross-sectional analysis of cases recruited in the Spanish FH cohort at inclusion was performed. Demographic, lifestyle, medical and therapeutic data were collected by specific surveys. Blood samples for lipid profile and DNA were obtained. Genetic test for FH was performed through DNA-microarray. Data from 1852 subjects (47.5% males) over 19 years old were analyzed: 1262 (68.1%, mean age 45.6 years) had genetic diagnosis of FH and 590 (31.9%, mean age 41.3 years) were non-FH. Cardiovascular disease was present in 14% of FH and in 3.2% of non-FH subjects (P < 0.001), and was significantly higher in patients carrying a null mutation compared with those carrying a defective mutation (14.87% vs. 10.6%, respectively, P < 0.05). Prevalence of current smokers was 28.4% in FH subjects. Most FH cases were receiving LLT (84%). Although 51.5% were receiving treatment expected to reduce LDL-c levels at least 50%, only 13.6% were on maximum statin dose combined with ezetimibe. Mean LDL-c level in treated FH cases was 186.5 mg/dl (SD: 65.6) and only 3.4% of patients reached and LDL-c under 100 mg/dl. The best predictor for LDL-c goal attainment was the use of combined therapy with statin and ezetimibe. Although most of this high risk population is receiving LLT, prevalence of cardiovascular disease and LDL-c levels are still high and far from the optimum LDL-c therapeutic goal. However, LDL-c levels could be reduced by using more intensive LLT such as combined therapy with maximum statin dose and ezetimibe.

  1. Clinical characteristics and evaluation of LDL-cholesterol treatment of the Spanish Familial Hypercholesterolemia Longitudinal Cohort Study (SAFEHEART)

    PubMed Central

    2011-01-01

    Aim Familial hypercholesterolemia (FH) patients are at high risk for premature coronary heart disease (CHD). Despite the use of statins, most patients do not achieve an optimal LDL-cholesterol goal. The aims of this study are to describe baseline characteristics and to evaluate Lipid Lowering Therapy (LLT) in FH patients recruited in SAFEHEART. Methods and Results A cross-sectional analysis of cases recruited in the Spanish FH cohort at inclusion was performed. Demographic, lifestyle, medical and therapeutic data were collected by specific surveys. Blood samples for lipid profile and DNA were obtained. Genetic test for FH was performed through DNA-microarray. Data from 1852 subjects (47.5% males) over 19 years old were analyzed: 1262 (68.1%, mean age 45.6 years) had genetic diagnosis of FH and 590 (31.9%, mean age 41.3 years) were non-FH. Cardiovascular disease was present in 14% of FH and in 3.2% of non-FH subjects (P < 0.001), and was significantly higher in patients carrying a null mutation compared with those carrying a defective mutation (14.87% vs. 10.6%, respectively, P < 0.05). Prevalence of current smokers was 28.4% in FH subjects. Most FH cases were receiving LLT (84%). Although 51.5% were receiving treatment expected to reduce LDL-c levels at least 50%, only 13.6% were on maximum statin dose combined with ezetimibe. Mean LDL-c level in treated FH cases was 186.5 mg/dl (SD: 65.6) and only 3.4% of patients reached and LDL-c under 100 mg/dl. The best predictor for LDL-c goal attainment was the use of combined therapy with statin and ezetimibe. Conclusion Although most of this high risk population is receiving LLT, prevalence of cardiovascular disease and LDL-c levels are still high and far from the optimum LDL-c therapeutic goal. However, LDL-c levels could be reduced by using more intensive LLT such as combined therapy with maximum statin dose and ezetimibe. PMID:21663647

  2. Evaluation of Respiratory Muscle Strength in Mouth Breathers: Clinical Evidences

    PubMed Central

    Andrade da Cunha, Renata; Andrade da Cunha, Daniele; Assis, Roberta Borba; Bezerra, Luciana Ângelo; Justino da Silva, Hilton

    2013-01-01

    Introduction The child who chronically breathes through the mouth may develop a weakness of the respiratory muscles. Researchers and clinical are seeking for methods of instrumental evaluation to gather complementary data to clinical evaluations. With this in mind, it is important to evaluate breathing muscles in the child with Mouth Breathing. Objective To develop a review to investigate studies that used evaluation methods of respiratory muscle strength in mouth breathers. Data Synthesis  The authors were unanimous in relation to manovacuometry method as a way to evaluate respiratory pressures in Mouth Breathing children. Two of them performed with an analog manovacuometer and the other one, digital. The studies were not evaluated with regard to the method efficacy neither the used instruments. Conclusion There are few studies evaluating respiratory muscle strength in Mouth Breathing people through manovacuometry and the low methodological rigor of the analyzed studies hindered a reliable result to support or refuse the use of this technique. PMID:25992108

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

    PubMed

    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.

  4. Evaluating information prescriptions in two clinical environments*

    PubMed Central

    Oliver, Kathleen Burr; Lehmann, Harold P; Wolff, Antonio C; Davidson, Laurie W; Donohue, Pamela K; Gilmore, Maureen M; Craven, Catherine K.

    2011-01-01

    Objective: The research sought to evaluate whether providing personalized information services by libraries can improve satisfaction with information services for specific types of patients. Methods: Adult breast cancer (BrCa) clinic patients and mothers of inpatient neonatal intensive care unit (NICU) patients were randomized to receive routine information services (control) or an IRx intervention. Results: The BrCa trial randomized 211 patients and the NICU trial, 88 mothers. The BrCa trial showed no statistically significant differences in satisfaction ratings between the treatment and control groups. The IRx group in the NICU trial reported higher satisfaction than the control group regarding information received about diagnosis, treatments, respiratory tradeoffs, and medication tradeoffs. BrCa patients posed questions to librarians more frequently than did NICU mothers, and a higher percentage reported using the website. Questions asked of the librarians by BrCa patients were predominantly clinical and focused on the areas of treatment and side effects. Conclusions: Study results provide some evidence to support further efforts to both implement information prescription projects in selected settings and to conduct additional research on the costs and benefits of services. PMID:21753916

  5. Recurrent PID, subsequent STI, and reproductive health outcomes: findings from the PID evaluation and clinical health (PEACH) study.

    PubMed

    Trent, Maria; Bass, Debra; Ness, Roberta B; Haggerty, Catherine

    2011-09-01

    PEACH trial data were used to evaluate the relationship between subsequent sexually transmitted infection and recurrent pelvic inflammatory disease on infertility and chronic pelvic pain (CPP). Recurrent pelvic inflammatory disease was associated with an almost 2-fold increase in infertility and more than 4-fold increase in CPP. Subsequent sexually transmitted infection was associated with CPP, but not infertility.

  6. Clinical Evaluation of the Measurement Performance of the Philips Health Watch: A Within-Person Comparative Study

    PubMed Central

    2017-01-01

    Background Physical inactivity is an important modifiable risk factor for chronic diseases. A new wrist-worn heart rate and activity monitor has been developed for unobtrusive data collection to aid prevention and management of lifestyle-related chronic diseases by means of behavioral change programs. Objective The objective of the study was to evaluate the performance of total energy expenditure and resting heart rate measures of the Philips health watch. Secondary objectives included the assessment of accuracy of other output parameters of the monitor: heart rate, respiration rate at rest, step count, and activity type recognition. Methods A within-person comparative study was performed to assess the performance of the health watch against (medical) reference measures. Participants executed a protocol including 15 minutes of rest and various activities of daily life. A two one-sided tests approach was adopted for testing equivalence. In addition, error metrics such as mean error and mean absolute percentage error (MAPE) were calculated. Results A total of 29 participants (14 males; mean age 41.2, SD 14.4, years; mean weight 77.2, SD 10.2, kg; mean height 1.8, SD 0.1, m; mean body mass index 25.1, SD 3.1, kg/m2) completed the 81-minute protocol. Their mean resting heart rate in beats per minute (bpm) was 64 (SD 7.3). With a mean error of −10 (SD 38.9) kcal and a MAPE of 10% (SD 8.7%), total energy expenditure estimation of the health watch was found to be within the 15% predefined equivalence margin in reference to a portable indirect calorimeter. Resting heart rate determined during a 15-minute rest protocol was found to be within a 10% equivalence margin in reference to a wearable electrocardiogram (ECG) monitor, with a mean deviation of 0 bpm and a maximum deviation of 3 bpm. Heart rate was within 10 bpm and 10% of the ECG monitor reference for 93% of the duration of the protocol. Step count estimates were on average 21 counts lower than a waist-mounted step

  7. Clinical Evaluation of the Measurement Performance of the Philips Health Watch: A Within-Person Comparative Study.

    PubMed

    Hendrikx, Jos; Ruijs, Loes S; Cox, Lieke Ge; Lemmens, Paul Mc; Schuijers, Erik Gp; Goris, Annelies Hc

    2017-02-02

    Physical inactivity is an important modifiable risk factor for chronic diseases. A new wrist-worn heart rate and activity monitor has been developed for unobtrusive data collection to aid prevention and management of lifestyle-related chronic diseases by means of behavioral change programs. The objective of the study was to evaluate the performance of total energy expenditure and resting heart rate measures of the Philips health watch. Secondary objectives included the assessment of accuracy of other output parameters of the monitor: heart rate, respiration rate at rest, step count, and activity type recognition. A within-person comparative study was performed to assess the performance of the health watch against (medical) reference measures. Participants executed a protocol including 15 minutes of rest and various activities of daily life. A two one-sided tests approach was adopted for testing equivalence. In addition, error metrics such as mean error and mean absolute percentage error (MAPE) were calculated. A total of 29 participants (14 males; mean age 41.2, SD 14.4, years; mean weight 77.2, SD 10.2, kg; mean height 1.8, SD 0.1, m; mean body mass index 25.1, SD 3.1, kg/m(2)) completed the 81-minute protocol. Their mean resting heart rate in beats per minute (bpm) was 64 (SD 7.3). With a mean error of -10 (SD 38.9) kcal and a MAPE of 10% (SD 8.7%), total energy expenditure estimation of the health watch was found to be within the 15% predefined equivalence margin in reference to a portable indirect calorimeter. Resting heart rate determined during a 15-minute rest protocol was found to be within a 10% equivalence margin in reference to a wearable electrocardiogram (ECG) monitor, with a mean deviation of 0 bpm and a maximum deviation of 3 bpm. Heart rate was within 10 bpm and 10% of the ECG monitor reference for 93% of the duration of the protocol. Step count estimates were on average 21 counts lower than a waist-mounted step counter over all walking activities

  8. Evaluation of moxifloxacin-hydroxyapatite composite graft in the regeneration of intrabony defects: A clinical, radiographic, and microbiological study

    PubMed Central

    Nagarjuna Reddy, Y. V.; Deepika, P. C.; Venkatesh, M. P.; Rajeshwari, K. G.

    2016-01-01

    Background: The formation of new connective periodontal attachment is contingent upon the elimination or marked reduction of pathogens at the treated periodontal site. An anti-microbial agent, i.e. moxifloxacin has been incorporated into the bone graft to control infection and facilitate healing during and after periodontal therapy. Materials and Methods: By purposive sampling, 15 patients with at least two contralateral vertical defect sites were selected. The selected sites in each individual were divided randomly into test and control sites according to split-mouth design. Test site received moxifloxacin-hydroxyapatite composite graft and control site received hydroxyapatite-placebo gel composite graft. Probing depth (PD) and Clinical attachment level (CAL) were assessed at baseline, 3, 6, 9, and 12 months. Bone probing depth (BPD) and hard tissue parameters such as amount of defect fill, percentage of defect fill, and changes in alveolar crest were assessed at baseline, 6, and 12 months. Changes in subgingival microflora were also assessed by culturing the subgingival plaque samples at baseline and at 3-month follow-up. The clinical, radiographic, and microbiological data obtained were subjected to statistical analysis using descriptive statistics, paired sample t-test, independent t-test, and contingency test. Results: On intragroup comparison at test and control sites, there was a significant improvement in all clinical and radiographic parameters. However, on intergroup comparison of the same, there was no statistically significant difference between test and control sites at any interval. Although test sites showed slightly higher amount of bone fill, it was not statistically significant. There was a significant reduction in the counts of Aggregatibacter actinomycetemcomitans and Porphyromonas gingivalis at both sites from baseline to 3 months. In addition, there was a significant reduction at test sites as compared to control sites at 3-month follow-up (P

  9. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: A clinical study

    PubMed Central

    Dhindsa, Abhishek; Pandit, I. K.; Srivastava, Nikhil; Gugnani, Neeraj

    2011-01-01

    One of the most distressing aspects of dentistry for pediatric patients is the fear and anxiety caused by the dental environment, particularly the dental injection. The application and induction of local anesthetics has always been a difficult task, and this demands an alternative method that is convenient and effective. Electronic dental anesthesia, based on the principal of transcutaneous electric nerve stimulation (TENS), promises to be a viable mode of pain control during various pediatric clinical procedures. Therefore, the aim of the present study was to evaluate the effectiveness of TENS and to compare its efficacy with 2% lignocaine during various minor pediatric dental procedures. Pain, comfort and effectiveness of both the anesthetics were evaluated using various scales and no significant difference was observed between 2% lignocaine and TENS in the various pain scales, while TENS was perceived to be significantly effective in comfort and efficacy as judged by the operator and quite comfortable as judged by the patient himself/herself. PMID:22114450

  10. Clinical evaluation of caries removal in primary teeth using conventional, chemomechanical and laser technique: an in vivo study.

    PubMed

    Bohari, Mariya R; Chunawalla, Yusuf K; Ahmed, Bijle Mohammed Nadeem

    2012-01-01

    To evaluate four different techniques of caries excavation in primary teeth in terms of efficacy, efficiency and pain experienced during the procedure. Sample of 120 teeth from children aged 5 to 9 years were equally divided into 4 groups - Air rotor (group A), Carisolv (group B), Papacarie (group C) and Er:YAG laser (group D). Visual and tactile criteria along with DIAGNOdent pen value was used to evaluate efficacy. Time was recorded to determine efficiency and FLACC scale was used to assess the pain experienced. Air rotor and laser were more effective and efficient method whereas laser and CMCR methods were more comfortable methods. Laser irradiation and CMCR methods are comparable to conventional methods in terms of effectiveness and are less painful methods. Newer techniques of CMCR and laser irradiation of dentinal caries are minimally invasive methods and are less painful and thus should be more frequently employed in pediatric dentistry.

  11. Detection and Evaluation of Early Breast Cancer via Magnetic Resonance Imaging: Studies of Mouse Models and Clinical Implementation

    DTIC Science & Technology

    2009-03-01

    University of Chicago developed for the SPORE project. The existing SPORE database collects detailed information on lesion pathology (such as TNM...cancer database at the University of Chicago set up as a SPORE funded project that collects pathologic, molecular and genetic information. This...calculated from the definition of curvature formula at time of Tpeak: peak A . [6] Data Analysis and Statistical Evaluation For the qualitative

  12. Clinical and biomechanical evaluation of three bioscaffold augmentation devices used for superficial digital flexor tenorrhaphy in donkeys (Equus asinus): An experimental study.

    PubMed

    El-Shafaey, El-Sayed A; Karrouf, Gamal I; Zaghloul, Adel E

    2013-01-01

    The present study was designed to carry out an in vivo and in vitro comparative evaluation of three bio-scaffold augmentation devices used for superficial digital flexor tenorrhaphy in donkeys. Twenty-four clinically healthy donkeys were assigned for three treatment trials (n = 8) using one of three bioscaffold materials (glycerolized bovine pericardium xenograft, tendon allograft and allograft with glycerolized by bovine pericardium). In addition, eight clinically healthy donkeys were selected to serve as control. Clinical signs of each animal were scored and the sum of all clinical indexes was calculated at each time point of the experiment. Four donkeys from each group were euthanized at 45 and 90 days postoperatively, respectively, for biomechanical and histopathological evaluation of treated superficial digital flexor tendon (SDFT). The failure stress in allograft shielding group significantly increased compared to the corresponding values of the other groups at 45 (62.7 ± 6.5 N mm(-2)) and 90 (88.8 ± 3.5 N mm(-2)) days postoperatively. The fetlock angle in the allograft shielding group at both 45 (112.8° ± 4.4) and 90 (123.8° ± 1.1) days postoperatively showed a significant increase (p < 0.05) relative to the values of the other groups and a significant decrease (p < 0.05) when compared to normal angle (125° ± 0). However, the histomorphological findings revealed no remarkable changes between the treatment groups. In conclusion, the failure stress, fetlock angle and histomorphological findings may provide useful information about the healing characteristics of SDFT tenorrhaphy. The bio-scaffold augmentation devices, either xenogenic or allogenic, provide good alternative techniques accelerating SDFT healing with minimal adhesions in donkeys.

  13. Synthetic sutures: Clinical evaluation and future developments.

    PubMed

    Abhari, Roxanna E; Martins, Joana A; Morris, Hayley L; Mouthuy, Pierre-Alexis; Carr, Andrew

    2017-09-01

    Today's sutures are the result of a 4000-year innovation process with regard to their materials and manufacturing techniques, yet little has been done to enhance the therapeutic value of the suture itself. In this review, we explore the historical development, regulatory database and clinical literature of sutures to gain a fuller picture of suture advances to date. First, we examine historical shifts in suture manufacturing companies and review suture regulatory databases to understand the forces driving suture development. Second, we gather the existing clinical evidence of suture efficacy from reviewing the clinical literature and the Food and Drug Administration database in order to identify to what extent sutures have been clinically evaluated and the key clinical areas that would benefit from improved suture materials. Finally, we apply tissue engineering and regenerative medicine design hypotheses to suture materials to identify routes by which bioactive sutures can be designed and passed through regulatory hurdles, to improve surgical outcomes. Our review of the clinical literature revealed that many of the sutures currently in use have been available for decades, yet have never been clinically evaluated. Since suture design and development is industry driven, incremental modifications have allowed for a steady outflow of products while maintaining a safe regulatory position and limiting costs. Until recently, there has been little academic interest in suture development, however the rise of regenerative medicine strategies is shifting the suture paradigm from an inert material, which mechanically approximates tissue, to a bioactive material, which also actively promotes cell-directed repair and a positive healing response. These materials hold significant therapeutic potential, but could be associated with an increased regulatory burden, cost, and clinical evaluation compared with current devices.

  14. Clinical Studies with Epothilones

    NASA Astrophysics Data System (ADS)

    Altmann, Karl-Heinz

    As indicated in previous chapters, epothilone research so far has delivered seven new chemical entities that have been advanced to clinical trials in humans (Fig. 1). However, the amount of clinical data publicly available at this time strongly varies between individual compounds, depending on their development stage, but also on the general publication policy of the developing company. The compound that has been most comprehensively characterized in the clinical literature is ixabepilone (BMS-247550), for which trial results have been described in a number of articles in peer-reviewed journals and which has been granted FDA approval for two clinical indications on Oct. 16, 2007. For all other compounds, most of the information on clinical trials is available only in abstract form. In all these cases it remains uncertain, whether the content of these abstracts fully reflects the content of the subsequent (poster or oral) presentations at the corresponding meeting; in fact, it seems likely that additional data will have been included in the actual meeting presentations that may not have been available at the time of abstract submission. As this is unknown to the author, such additional information cannot be considered in this chapter, which is solely based on information documented in accessible abstracts or journal publications. It should also be kept in mind that the interpretation of data from ongoing clinical trials or forward looking statements based on data from completed trials are always preliminary in character.

  15. Clinical and histological evaluation of an analogue of palmitoylethanolamide, PLR 120 (comicronized Palmidrol INN) in cats with eosinophilic granuloma and eosinophilic plaque: a pilot study.

    PubMed

    Scarampella, F; Abramo, F; Noli, C

    2001-02-01

    Fifteen cats with eosinophilic granuloma or eosinophilic plaque were given PLR 120 at the dosage of 10 mg kg-1 twice daily for one month. PLR-120 down-modulates mast cell degranulation via a receptor-mediated mechanism. No other drugs were permitted and cats were kept free of parasites throughout the study. A clinical evaluation and skin biopsies were performed before and after the treatment. Clinical improvement was assessed at 15 and 30 days. Mast cell numbers were counted and their granular content was assessed by densitometric analysis on toluidine blue-stained sections before and after the treatment. Ten of 15 (67%) cats showed clinical improvement of signs and lesions. There was no significant difference between mast cell numbers in skin biopsies taken before and after the trial, whereas the number of granules was significantly increased (P < 0.009). This pilot study suggests that PLR-120 might be a useful drug for the treatment of eosinophilic granuloma and eosinophilic plaque.

  16. Hormonal and barrier contraception and risk of upper genital tract disease in the PID Evaluation and Clinical Health (PEACH) study.

    PubMed

    Ness, R B; Soper, D E; Holley, R L; Peipert, J; Randall, H; Sweet, R L; Sondheimer, S J; Hendrix, S L; Amortegui, A; Trucco, G; Bass, D C; Kelsey, S F

    2001-07-01

    Among women diagnosed with pelvic inflammatory disease, we examined the associations between hormonal or barrier methods of contraception and upper genital tract infection or inflammation. Participants were 563 patients from a treatment trial for pelvic inflammatory disease. All had pelvic pain; pelvic organ tenderness; and leukorrhea, mucopurulent cervicitis, or untreated cervicitis. Contraceptive use within the prior 4 weeks was compared among women with baseline upper genital tract gonorrhea or chlamydia, women with endometritis without upper genital tract gonorrhea or chlamydia, and women with neither upper genital tract gonorrhea or chlamydia nor endometritis. Inconsistent condom use was significantly and independently associated with a 2 to 3 times elevated risk for upper genital tract infection. Upper genital tract gonorrhea or chlamydia was not significantly associated with use of oral contraceptives, use of medroxyprogesterone, condoms used consistently, nor other barrier methods. No hormonal or barrier contraceptive method was related to a reduction in upper genital tract disease among women with clinical pelvic inflammatory diseases.

  17. Clinical Evaluation in a Family Medicine Residency.

    ERIC Educational Resources Information Center

    Herman, James M.; And Others

    1985-01-01

    A study assessed (1) the validity of the Bowman Gray School of Medicine evaluation instrument regarding the occurrence of halo effects and (2) possible relationships between the faculty's evaluations of the residents and the residents' cognitive knowledge and productivity. (MLW)

  18. Clinical Evaluation in a Family Medicine Residency.

    ERIC Educational Resources Information Center

    Herman, James M.; And Others

    1985-01-01

    A study assessed (1) the validity of the Bowman Gray School of Medicine evaluation instrument regarding the occurrence of halo effects and (2) possible relationships between the faculty's evaluations of the residents and the residents' cognitive knowledge and productivity. (MLW)

  19. A phase IIa randomized controlled pilot study evaluating the safety and clinical outcomes following the use of rhGDF-5/β-TCP in regenerative periodontal therapy.

    PubMed

    Windisch, Péter; Stavropoulos, Andreas; Molnár, Bálint; Szendröi-Kiss, Dóra; Szilágyi, Emese; Rosta, Péter; Horváth, Attila; Capsius, Björn; Wikesjö, Ulf M E; Sculean, Anton

    2012-08-01

    To present the safety profile, the early healing phase and the clinical outcomes at 24 weeks following treatment of human intrabony defects with open flap debridement (OFD) alone or with OFD and rhGDF-5 adsorbed onto a particulate β-tricalcium phosphate (β-TCP) carrier. Twenty chronic periodontitis patients, each with at least one tooth exhibiting a probing depth ≥6 mm and an associated intrabony defect ≥4 mm entered the study. Ten subjects (one defect/patient) were randomized to receive OFD alone (control) and ten subjects OFD combined with rhGDF-5/β-TCP. Blood samples were collected at screening, and at weeks 2 and 24 to evaluate routine hematology and clinical chemistry, rhGDF-5 plasma levels, and antirhGDF-5 antibody formation. Plaque and gingival indices, bleeding on probing, probing depth, clinical attachment level, and radiographs were recorded pre- and 24 weeks postsurgery. Comparable safety profiles were found in the two treatment groups. Neither antirhGDF-5 antibody formation nor relevant rhGDF-5 plasma levels were detected in any patient. At 6 months, treatment with OFD + rhGDF-5/β-TCP resulted in higher but statistically not significant PD reduction (3.7 ± 1.2 vs. 3.1 ± 1.8 mm; p = 0.26) and CAL gain (3.2 ± 1.7 vs. 1.7 ± 2.2 mm; p = 0.14) compared to OFD alone. In the tested concentration, the use of rhGDF-5/β-TCP appeared to be safe and the material possesses a sound biological rationale. Thus, further adequately powered, randomized controlled clinical trials are warranted to confirm the clinical relevance of this new approach in regenerative periodontal therapy. rhGDF-5/β-TCP may represent a promising new techology in regenerative periodontal therapy.

  20. Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

    PubMed

    Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

    2014-02-01

    The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial.

  1. A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits.

    PubMed

    Housler, Greggory J; Cross, Sue; Marcel, Vanessa; Kennedy, Daniel O; Husband, Michael; Register, Andrew; Roberts, Thomas; Grubbs, Seth; Dudewicz, Douglas; Setka, Nathan; Bay, Curt; Wendelken, Martin E; Izadjoo, Mina J

    This study focused on a clinically relevant healthcare problem in the military: acute soft tissue wounds, or blisters. The trial was a prospective, controlled, randomized two-arm study evaluating the efficacy of a bioelectric dressing, Procellera®, applied topically two to three times per week for 2 weeks to blisters developed in Ranger trainees during training at Fort Benning, Georgia. A total of 80 US Army Ranger recruits with blister wounds below the knee were randomly assigned to one of two treatment groups (n = 40/group). The primary goal was to assess the clinical efficacy (rate of healing) of administered Procellera in conjunction with the standard-of-care (SOC) treatment, moleskin and Tegaderm ®, on the healing rate of blisters compared with the SOC treatment alone. The secondary end points for efficacy were the quantities of wound fluid biomarkers and bacterial bioburden. The tertiary end point was assessment of pain in the treatment group compared with that of the control group during the 2-week study. The results showed no statistical difference between the SOC and SOC+Procellera groups in wound healing and pain. Wound fluid was reported for 24 participants (64.9%) in the SOC group and 21 participants (56.8%) in SOC+Procellera group at the baseline measurement (ρ = .475); however, the wounds were devoid of fluid on follow-up visits. The mild nature of the wounds in this study was apparent by the low pain scores at the beginning of the study, which disappeared by the follow-up visits. The average wound sizes were 2.2cm2 and 1.5cm2 for the SOC and SOC+Procellera groups, respectively. This trial protocol should be conducted on open softtissue wounds in severe heat. To our knowledge, this is the first clinical study conducted within the US Army Rangers training doctrine. 2017.

  2. Clinical evaluation of Papacarie in primary teeth.

    PubMed

    Kotb, Rehab Mohamed Salah; Abdella, Ahmed AbdelHamid; El Kateb, Mona Abdullah; Ahmed, Amel Mahmoud

    2009-01-01

    The change in the concepts of cavity preparation and the development of reliable adhesive materials lead to the development of alternative methods of caries removal. Chemo-mechanical caries removal (CMCR) involves the chemical softening of carious dentin, followed by its removal with gentle excavation. The present study was conducted to evaluate clinically the efficiency of caries removal using a new chemo-mechanical agent (Papacarie) compared to the conventional drilling method including the need for local anesthesia, the need for drill, duration of the treatment and the pain reaction. This study was split mouth design. The study was performed on thirty seven bilateral open carious lesions. They were divided into two equal groups according to method of caries removal. In Group I, caries was removed using the Papacarie system and in Group II, caries was removed with the conventional drill. The results showed that the Papacarie was as efficient as the drill in caries removal from open carious lesions with no significant difference in the operating time. The new CMCR agent also reduced significantly the need for local anesthesia and the use of drill. In addition, Papacarie was also more comfortable than the traditional rotatory instruments. It was concluded that Papacarie could be an effective caries removal method to treat children, particularly those who present with early childhood caries or management problems.

  3. Benign prostatic hyperplasia: clinical manifestations and evaluation.

    PubMed

    Santos Dias, José

    2012-12-01

    Benign prostatic hyperplasia (BPH) is a very common condition, related to aging and causing symptoms, called lower urinary tract symptoms. On account of its huge prevalence, it is important for clinicians who are involved in the management of patients with BPH to be aware of the very strict recommendations for BPH evaluation. In this article, we describe the different steps and procedures doctors should follow to evaluate these patients; symptoms and signs of BPH are reviewed, as well as the clinical evaluation steps and examinations available. The basic evaluation of the patients with BPH should include, according to the recommendations of the most relevant international guidelines, lower urinary tract symptoms evaluation with appropriate symptom scores, digital rectal examination, voiding charts, prostate-specific antigen and creatinine measurement, urinalysis, and imaging of the urinary tract.

  4. A comparative evaluation of topical and intrasulcular application of coenzyme Q10 (Perio Q™) gel in chronic periodontitis patients: A clinical study

    PubMed Central

    Sale, Srinivasa Tenka; Parvez, Humera; Yeltiwar, Ramreddy Krushna Rao; Vivekanandan, Gopinath; Pundir, Aena Jain; Jain, Priya

    2014-01-01

    Background and Objectives: Coenzyme Q10 is a well-studied antioxidant in the medical literature, but studies regarding its efficacy in periodontal diseases are few. coenzymeoenzyme Q10 serves as an endogenous antioxidant and its increased concentration in the diseased gingiva effectively suppresses advanced periodontal inflammation. The aim of this study is to evaluate the efficacy of coenzyme Q10 (Perio Q™) as an adjunct to scaling and root planing in patients with chronic periodontitis. Materials and Methods: A total of 18 patients were enrolled for the study. The selected subjects were treated in three different quadrants randomly. The control quadrant was treated by scaling and root planing only, while the other two test quadrants were treated by intra-pocket application of gel combined with scaling or root planing and topical applications combined with scaling and root planning, respectively. Clinical parameters such as plaque index, gingival index, gingival bleeding index and probing pocket depth were assessed at baseline and at the 2nd week and 4th weeks. The results were subjected to statistical analysis. Results: There was a significant improvement in all clinical parameters in the test sites seen at the end of the 4-week period. Sites with bleeding on probing were reduced more in the test group than in the control group. Conclusion: Coenzyme Q10 can be said to have a beneficial effect on periodontitis when used as an adjunct to scaling and root planing. PMID:25210260

  5. The clinical efficacy of Diphoterine® in the management of cutaneous chemical burns: a 2-year evaluation study.

    PubMed

    Zack-Williams, S D L; Ahmad, Z; Moiemen, N S

    2015-03-31

    Diphoterine(®) is an amphoteric irrigating agent for the treatment of chemical burns and rapidly neutralises both acids and alkalis faster than water alone. Diphoterine(®) is widely used as a first aid agent in a wide range of industries globally. This is a retrospective review of the clinical use of Diphoterine(®) on chemical burns in an adult tertiary referral burn centre, often with a delay of several hours after the injury. patients admitted with chemical burns within 24 hours of the incident with an abnormal wound pH or in pain, were treated with Diphoterine(®) spray. Over a 32-month period, 1,875 burn referrals were admitted of which 131 (7%) were chemical burns. Diphoterine(®) was used in 47 patients (36%). The male to female ratio for the 131 patients was 4:1. Alkaline burns were the commonest (55%). patients who received Diphoterine(®) were significantly younger (38 vs 43 years; p=0.05) and presented earlier (0.5 vs 2.55 days; p=0.004). There was a significant change in the wound pH pre- and post-application of Diphoterine(®), compared to patients who were treated with water irrigation only, with a pH change of 1.076 vs 0.4 (p <0.05). There was no significant difference in the time to healing, the length of hospital stay, or need for surgery. in conclusion, based on our retrospective cohort, Diphoterine(®) could be a valuable tool for use in hospital settings to neutralise both alkaline and acid burns.

  6. Evaluation of the efficacy of 100% Type-I collagen membrane of bovine origin in the treatment of human gingival recession: A clinical study

    PubMed Central

    Soni, Nitin; Sikri, Poonam; Kapoor, Daljit; Soni, Bhavita Wadhwa; Jain, Rachna

    2014-01-01

    Background: Various treatment modalities have been devised for gingival recession, which is one of the most common signs of periodontal disease. The present study evaluates the efficacy of bioresorbable 100% type I collagen membrane of bovine origin in the treatment of human gingival recession. Materials and Methods: Twenty cases of Miller's class I or class II localized gingival recession defects on the facial surface were treated with 100% type I collagen membrane of bovine origin in conjunction with coronally positioned flap. Pre-operative and post-operative assessments were performed with respect to probing pocket depth, clinical attachment level and clinical recession at 12, 24 and 36 weeks. The data thus collected were analyzed statistically. Results: Statistically significant improvement based on Student's t test was found in all the three clinical parameters. Conclusion: Bioresorbable 100% type I collagen membrane of bovine origin has given inspiring results in the treatment of human gingival recession defects, thereby justifying the use of this material wherever indicated. PMID:25565742

  7. Evaluation of the effect of hydrogen peroxide as a mouthwash in comparison with chlorhexidine in chronic periodontitis patients: A clinical study

    PubMed Central

    Rashed, Hazem Tarek

    2016-01-01

    Aims and Objective: This study was conducted to evaluate the effect of hydrogen peroxide (H2O2) as a mouthwash in comparison with chlorhexidine (CHX) in chronic periodontitis patients. Materials and Methods: A total of 45 patients suffering from localized mild to moderate chronic periodontitis were chosen. The subjects were divided equally into three groups. Group A patients were treated only with scaling and root planning (SRP). Group B were treated with SRP in combination with 0.2% CHX gluconate mouthwash twice daily for 10 days. Group C were treated with SRP in combination with 1.5% H2O2 mouthwash twice daily for 10 days. Gingival index, plaque index, pocket depth, and clinical attachment level were recorded for patients of all groups on day 0 (Baseline), 15, 30, and 90, respectively. Statistical analysis was done using the Statistical Package for the Social Sciences version 22.0. Repeated measures analysis of variance was used to assess the differences in the abovementioned indices because of time and groups. Results: Both CHX gluconate and H2O2 mouthwashes significantly reduced the gingival index more than that observed in the control group, but similar to each other. There were no significant differences in the clinical attachment loss, plaque index, and pocket depth among the study groups, but improvement was seen within the CHX group participants. In participants with chronic periodontitis, SRP in combination with 0.2% CHX gluconate mouthwash was an effective treatment in reducing the gingival index and the pocket depth, as well as improving the clinical attachment level. Conclusion: The use of CHX gluconate was observed to be higher than H2O2 for the reduction in the gingival index and the pocket depth, as well as for the improvement of the clinical attachment level. PMID:27382535

  8. Preliminary Evaluation of Clinical and Angiographic Outcomes with Biodegradable Polymer Coated Sirolimus-Eluting Stent in De Novo Coronary Artery Disease: Results of the MANIPAL-FLEX Study

    PubMed Central

    Prajapati, Jayesh; Pai, Umesh; Shetty, Kiran

    2016-01-01

    Objective. The objective of the MANIPAL-FLEX study was to evaluate the feasibility, preliminary safety, and efficacy of the Supraflex sirolimus-eluting stent (SES) implantation, in de novo coronary artery disease, using clinical and quantitative coronary angiography (QCA) follow-ups. Methods. This was a prospective, nonrandomized, multicenter, single-arm study that enrolled 189 patients with de novo coronary artery disease who were treated with the Supraflex SES. Of 189 patients enrolled, the first 61 consecutive patients who consented to a 9-month follow-up evaluation by QCA, irrespective of presence of symptoms, were to be followed up with angiography at 9 months. The primary endpoint of the study was target lesion failure (TLF), including cardiac death, myocardial infarction, and target lesion revascularization during 12-month follow-up after the index procedure. Results. The mean age of the study population was 58 ± 11 years, with 51.3% (97/189) of hypertensive patients. Total of 66 lesions, analyzed by offline QCA, showed good scaffolding of the target vessel with in-stent late lumen loss at 9 months of 0.18 ± 0.23 mm. The observed TLF at 30-day, 6-month, and 12-month follow-up were 2 (1.1%), 6 (3.2%), and 10 (5.3%), respectively. Conclusion. This study provides preliminary evidence for the feasibility, safety, and efficacy of the Supraflex sirolimus-eluting stent. PMID:27597929

  9. A comparative evaluation of the blood clot, platelet-rich plasma, and platelet-rich fibrin in regeneration of necrotic immature permanent teeth: A clinical study

    PubMed Central

    Narang, Isha; Mittal, Neelam; Mishra, Navin

    2015-01-01

    Introduction: This study was designed as a clinical trial to evaluate and compare the regenerative potential of platelet-rich fibrin (PRF), platelet-rich plasma (PRP), and blood clot in immature necrotic permanent teeth with or without associated apical periodontitis. Methods: Access preparation was done under rubber dam isolation. Copious irrigation was done with 2.5% NaOCl and triple antibiotic paste was placed as an intracanal medicament. After 4 weeks, the cases were divided into four groups with five patients in each group. The study design had three test arms and one control arm. Group I in which mineral trioxide aggregate apexification was carried out and it was kept as control group to evaluate the regenerative potential of blood clot and platelet concentrates, Group II in which blood clot was used as scaffold in the canal, Group III in PRF was used as scaffold, and Group IV in which PRP carried on collagen was used as a scaffold. Results: The clinical and radiographic evaluation after 6 and 18 months was done by two independent observers who were blinded from the groups. The scoring was done as: None score was denoted by, Fair by 1, Good by 2, and Excellent by 3. The data were then analyzed statistically by Fisher's exact test using Statistics and Data 11.1(PRP Using harvest Smart PReP2) which showed statistically significant values in Group III as compared to other Groups. Conclusion: PRF has huge potential to accelerate the growth characteristics in immature necrotic permanent teeth as compared to PRP and blood clot. PMID:25684914

  10. Clinical study of a new Modified Early Warning System scoring system for rapidly evaluating shock in adults.

    PubMed

    Qin, Qin; Xia, Yiqin; Cao, Yu

    2017-02-01

    Shock, the most common severe emergency syndrome, has a complicated etiopathogenesis, is difficult to identify, progresses quickly, and is dangerous. Early identification and intervention play determining roles in the final outcomes of shock patients, but no specific scoring system for shock has been established to date. We collected 292 shock patients and analyzed the correlation between 28-day prognosis and the Acute Physiologic Assessment and Chronic Health Evaluation II (APACHE II), Modified Early Warning System (MEWS), and Sequential Organ Failure Assessment scoring systems. According to the previous result, we established a new MEWS scoring system based on the conventional MEWS, which also included age and transcutaneous oxygen saturation. Some of the items with a strong correlation with the 28-day prognosis were selected to establish the new MEWS scoring system. We then evaluated the predictive efficacy of the new MEWS scoring system on 28-day prognosis and the correlation with other scoring systems. Some indexes, including age, transcutaneous oxygen saturation, arterial blood pH and blood lactic acid, serum sodium, serum potassium, HCO3, and red blood cells deposited, differed significantly between the nonsurviving and surviving groups (P<.05). The area under the curve (AUC) of the APACHE II, MEWS, shock index, and Sequential Organ Failure Assessment scoring systems for 28-day prognosis indicated a critical predictive efficacy. Receiver operating characteristic curves indicated that the MEWS AUC was 0.614, new MEWS AUC was 0.696, and APACHE II AUC was 0.785, suggesting superiority of the new MEWS to the conventional MEWS but inferiority to the APACHE II. Interestingly, the correlation efficient of the traditional MEWS and the new MEWS was 0.81. The correlation efficient of these scoring systems with other indexes, including lactic acid and hemoglobin, was less than 0.3. The new MEWS scoring system could be an independent indicator to reflect shock severity

  11. The evaluation of coagulation parameters and vessel involvement in Behcet' s disease. A clinical experience of Behcet' s disease: study of 152 cases.

    PubMed

    Harman, Ece; Sayarlıoglu, Mehmet; Harman, Mustafa; Sayarlıoglu, Hayriye

    2013-05-07

    Behcet´s disease (BD) is accepted as a systemic vasculitis. Vasculitis is observed  predominantly on the venous system. Vessel involvement is frequently seen in males. This study was planned retrospectively evaluate demographic features, clinical features, vessel involvements in BD. Furthermore, we aimed to prospectively compare consecutively chosen patients with and without thrombosis and healthy volunteers in terms of their biochemical, immunological, coagulation parameters. One hundred fifty-two Behcet´s patients were retrospectively evaluated. Blood samples were collected from 52 consecutively chosen patients and 41 healthy subjects. Papulopustular skin lesions, eye involvement and venous lesions were detected frequent in males. In terms of evaluated parameters (biochemical parameters, coagulation parameters, C-reactive protein, erythrocyte sedimentation rate, anticardiolipin antibodies, antinuclear antibody positivity) was not found a significant difference among groups (patients without thrombosis, healthy control subjects, patients with thrombosis). We detected statistically significant difference in terms of factor V levels between patient and control group. The tendency to thrombosis in patients with BD is well known. The endothelial lesion, increased procoagulant activity, hypofibrinolysis were found to be responsible from these events. In our study, there was no significant difference in terms of coagulation parameters between the patients without and with thrombosis.

  12. Strategies for inhibitor treatment and costs in the short and long term: a critical evaluation of recent clinical studies.

    PubMed

    Baghaipour, Mohammad Reza; Steen Carlsson, Katarina

    2015-02-01

    One important complication of patients with severe haemophilia A is the formation of inhibitory antibodies to factor VIII (FVIII). Immune tolerance induction (ITI) is the treatment of choice for patients with inhibitors, but this approach is successful in about 60% of patients. Treatment of acute bleeding in patients with inhibitors is one of the greatest challenges in haemophilia management and is costly. Bypassing agents are the mainstay of treatment in these patients. The aims of this study were to review the most recent publications concerning the costs of inhibitor treatment. We conducted a literature review using PubMed which yielded 63 papers analysing the costs of inhibitor management of which 12 were suitable for our study. Four of eight studies supported the use of activated prothrombin complex concentrate (aPCC) with lower costs, but the remaining four studies showed that recombinant factor VIIa (rFVIIa) had a lower average treatment cost. Of four ITI studies, two supported lifelong cost-effectiveness of ITI vs. bypassing agents and the remaining two papers showed a high cost of inhibitor treatment. Dosages, time between onset of bleeding and treatment, patient characteristics and the price of drugs are some of the important issues that should be considered for further studies.

  13. Evaluation of the Anti-Inflammatory Effect of Locally Delivered Vitamin C in the Treatment of Persistent Gingival Inflammation: Clinical and Histopathological Study

    PubMed Central

    Abdul Aziz, Manar A.; Abdel Rahman, Ahmed R.

    2016-01-01

    Objective. The purpose of this study is to investigate the role and efficiency of the locally injected vitamin C in the treatment of persistent gingival inflammation. Design. Twenty adult patients with persistent chronic gingival inflammation were included in this study. The same dose of sterile vitamin C was injected in gingival tissues after the completion of phase I therapy. Gingival biopsies were taken after total resolution of inflammation. The specimens were examined histologically, using H&E stain. Results. Clinical evaluation revealed great improvement of the injected sites with recall visits. Histopathological results revealed marked decrease in inflammatory cells and epithelial thickness and a higher number of newly formed subbasal capillaries. Conclusions. Vitamin C is an effective adjunctive treatment in reducing various degrees of chronic gingival inflammation. PMID:28050280

  14. Clinical study of contrast-enhanced digital mammography and the evaluation of blood and lymphatic microvessel density

    PubMed Central

    Cruz-Bastida, Juan P; Rosado-Méndez, Iván M; Villaseñor-Navarro, Yolanda; Pérez-Ponce, Héctor; Galván, Héctor A; Trujillo-Zamudio, Flavio E; Sánchez-Suárez, Patricia; Benítez-Bribiesca, Luis

    2016-01-01

    Objective: To correlate image parameters in contrast-enhanced digital mammography (CEDM) with blood and lymphatic microvessel density (MVD). Methods: 18 Breast Imaging-Reporting and Data System (BI-RADS)-4 to BI-RADS-5 patients were subjected to CEDM. Craniocaudal views were acquired, two views (low and high energy) before iodine contrast medium (CM) injection and four views (high energy) 1–5 min afterwards. Processing included registration and two subtraction modalities, traditional single-energy temporal (high-energy) and “dual-energy temporal with a matrix”, proposed to improve lesion conspicuity. Images were calibrated into iodine thickness, and iodine uptake, contrast, time–intensity and time–contrast kinetic curves were quantified. Image indicators were compared with MVD evaluated by anti-CD105 and anti-podoplanin (D2-40) immunohistochemistry. Results: 11 lesions were cancerous and 7 were benign. CEDM subtraction strongly increased conspicuity of lesions enhanced by iodine uptake. A strong correlation was observed between lymphatic vessels and blood vessels; all benign lesions had <30 blood microvessels per field, and all cancers had more than this value. MVD showed no correlation with iodine uptake, nor with contrast. The most frequent curve was early uptake followed by plateau for uptake and contrast in benign and malignant lesions. The positive-predictive value of uptake dynamics was 73% and that of contrast was 64%. Conclusion: CEDM increased lesion visibility and showed additional features compared with conventional mammography. Lack of correlation between image parameters and MVD is probably due to tumour tissue heterogeneity, mammography projective nature and/or dependence of extracellular iodine irrigation on tissue composition. Advances in knowledge: Quantitative analysis of CEDM images was performed. Image parameters and MVD showed no correlation. Probably, this is indication of the complex dependence of CM perfusion on tumour

  15. Clinical evaluation of the intraoral fluoride releasing system in radiation-induced xerostomic subjects. Part 2: Phase I study.

    PubMed

    Chambers, Mark S; Mellberg, James R; Keene, Harris J; Bouwsma, Otis J; Garden, Adam S; Sipos, Tibor; Fleming, Terence J

    2006-10-01

    Radiation-induced xerostomia can result in the rapid onset and progression of dental caries in head and neck cancer patients. Topically applied fluorides have been successfully used to inhibit the formation of dental caries in this population. However, because intensive daily self-application is required, compliance is an issue. The intraoral fluoride-releasing system (IFRS) containing a sodium fluoride core is a newly developed, sustained-release, passive drug delivery system that does not require patient involvement except for periodic replacement, thus reducing the effect of patient compliance on its effectiveness in dental caries prevention. Twenty-two head and neck cancer patients from U. T. M. D. Anderson Cancer Center, with radiation-induced xerostomia, were entered into a pilot study to contrast the daily home use of a 0.4% stannous fluoride-gel-containing tray (control group) to IFRS (study group) with respect to tolerability and adherence, and to obtain information on relative caries preventive efficacy. Participants were stratified on the basis of radiation exposure and randomly assigned to treatment with either IFRS or stannous fluoride gel. Patients in both groups were fitted with two IFRS retainers and also were instructed to use a 1100-ppm fluoride conventional sodium fluoride dentifrice twice daily. The study was conducted as a single-blinded, parallel-cell trial. Pre-existing carious lesions were restored prior to the beginning of the study. The efficacy variable was determined by the mean number of new or recurrent decayed surfaces. Patients were examined for caries 4, 8, 12, 24, 36, and 48 weeks after initiation of treatment. Reports of adverse reactions were based on information volunteered by patients and that were elicited during interviews. At baseline, the resting and stimulated salivary flow rates (g/5min) were significantly greater in the control group than in the study group (p<0.05). Patients in the control group had received

  16. Role of ultrasonographic/clinical profile, cytology, and BRAF V600E mutation evaluation in thyroid nodule screening for malignancy: a prospective study.

    PubMed

    Rossi, Martina; Buratto, Mattia; Bruni, Stefania; Filieri, Carlo; Tagliati, Federico; Trasforini, Giorgio; Rossi, Roberta; Beccati, Maria Donatella; Degli Uberti, Ettore C; Zatelli, Maria Chiara

    2012-07-01

    Ultrasound (US)-guided fine-needle aspiration biopsy (FNAB) is the most reliable nonsurgical test for distinguishing benign from malignant thyroid nodules. However, there is no consensus on which nodules should undergo FNAB. The aims of this study were to evaluate the utility of US-guided FNAB in the diagnostic assessment of nodules with or without clinical/US features suggestive for malignancy and to investigate the additional contribution of BRAF V600E mutation analysis in the detection of differentiated thyroid cancer. Thyroid cytoaspirates from 2421 nodules at least 4 mm in diameter were performed in 1856 patients who underwent cytological evaluation and biomolecular analysis. Cytology showed high positive predictive value and specificity for the diagnosis of malignant lesions. BRAF V600E mutation was found in 115 samples, 80 of which were also cytologically diagnosed as papillary thyroid cancer. BRAF mutation analysis significantly enhanced the diagnostic value of cytology, increasing FNAB diagnostic sensitivity for malignant nodules by approximately 28%. Micro PTC (63% of diagnosed papillary thyroid carcinoma) showed a high prevalence of multifocality, extrathyroidal extension, and lymph node metastases, underlining the malignant potential of thyroid microcarcinomas. Each investigated US/clinical characteristic of suspected malignancy correlated with the presence of a thyroid cancer in thyroid nodules with diameter of at least 4 mm. These data indicate that nodules of at least 4 mm may underlie a thyroid cancer independently of US/clinical characteristics of suspected malignancy, suggesting the need to perform FNAB. The diagnostic sensitivity for thyroid cancer is significantly increased by BRAF V600E mutation analysis, indicating that the screening for BRAF mutation in FNAB samples has a relevant diagnostic potential.

  17. The final follow-up plain radiograph is sufficient for clinical evaluation of polyethylene wear in total hip arthroplasty. A study of validity and reliability.

    PubMed

    Stilling, Maiken; Larsen, Kristian; Andersen, Niels T; Søballe, Kjeld; Kold, Søren; Rahbek, Ole

    2010-10-01

    Radiostereometric analysis (RSA) is a highly accurate tool for assessment of polyethylene (PE) wear in total hip arthroplasty (THA); however, PE wear measurements in clinical studies are often limited to plain radiographs. We evaluated the agreement between PE wear measured with PolyWare software, which uses plain radiographs, and by model-based RSA, which uses stereo radiographs. Measurements of PE wear postoperatively and at final follow-up (after mean 6 years) on plain radiographs of 12 patients after cementless THA were evaluated with PolyWare software and the results were compared with those from RSA as the gold standard (Model-based RSA using elementary geometrical shape models; EGS-RSA). With PolyWare, we either used the final radiographic follow-up (PW1) only or both the postoperative follow-up and the final follow-up (PW2). The 2D mean wear measured (in mm) was 0.80, 1.07, and 0.60 for the PW2, PW1, and RSA method. 2D intra-method repeatability was similar for PW1 and RSA with limits of agreement (LOAs, in mm) of ± 0.22, and ± 0.23, respectively. 2D inter-method concurrent validity was best between PW1 and EGS-RSA with LOAs of ± 0.55. For 2D linear wear measurements, the PW1 method had a clinical repeatability similar to that of RSA. PW1 is sufficient for retrospective determination of 2D wear from medium-term wear measurements above 0.5 mm, It alleviates the need for baseline plain radiographs, has a clinical precision similar to that of RSA, and is easy and inexpensive to use.

  18. Clinical and radiographical evaluation of a bioresorbable collagen membrane of fish origin in the treatment of periodontal intrabony defects: A preliminary study

    PubMed Central

    Santosh Kumar, B. B.; Aruna, D. R.; Gowda, Vinayak S.; Galagali, Sushama R.; Prashanthy, R.; Navaneetha, H.

    2013-01-01

    Background: Recently, there has been interest in non-mammalian collagen sources such as fish collagen in periodontal regeneration. In the present study, collagen barrier membrane of fish origin was assessed in the treatment of periodontal intrabony defects. Materials and Methods: Ten systemically healthy chronic periodontitis patients having a paired osseous defect in the mandibular posterior teeth were selected and randomly assigned to receive a collagen membrane (test) or open flap debridement (control) in a split mouth design. Clinical parameters such as Plaque index, Gingival bleeding index, Probing pocket depth, Relative attachment level, and Recession were recorded at baseline, 3, 6, and at 9 months, while radiographic evaluation was done to assess alveolar crestal bone level and percentage of defect fill at 6 and 9 months using autoCAD 2007 software. Student's t test (two-tailed, dependent) was used to find the significance of study parameters on continuous scale. Significance was set at 5% level of significance. Wilcoxon signed rank test was used to find the significance of percentage change of defect fill. Results: The comparison between the two groups did not show any statistically significant differences in the parameters assessed (P > 0.05) but, within each group, clinical parameters showed statistically significant differences from baseline to 9 months (P < 0.05). Conclusion: Within the limits of the study, it can be inferred that no significant differences were found either by using collagen membrane of fish origin or open flap debridement in the treatment of periodontal intrabony defects. PMID:24174757

  19. In vitro Comparative Evaluation of Various Restorative Materials used for restoring Class III Cavities in Deciduous Anterior Teeth: A Clinical Study.

    PubMed

    Priyank, Harsh; Verma, Ankita; Gupta, Komal; Chaudhary, Esha; Khandelwal, Deepak; Nihalani, Shweta

    2016-12-01

    Beauty standards in today's modernized world scenario are formed by well-aligned and well-designed bright white teeth. One of the major reasons behind patients reporting to dental clinics is pain. Caries in the anterior primary teeth forms one of the major concerns from a restorative point of view. Very few studies are quoted in literature which stresses on the follow-up of anterior restorations in primary teeth. Hence, we evaluated and compared the efficacy of composite resin and resin-modified glass ionomer cement (RGIC) for class III restorations in primary anterior teeth. The present study was conducted in the pediatric dental wing and included a total of 80 patients aged 3 to 5½ years who reported with the chief complaint of carious lesions in the primary anterior teeth. Patients having minimal of a pair of similar appearing small carious lesions on the same proximal surfaces of the deciduous maxillary incisors were included for the study. All the patients were randomly divided into two groups: One in which RGIC restoration was done and other in which composite restoration was done. Cavity preparation was done and filling of the cavity with the restorative materials was carried out. Assessment of the restorations was done at 4, 8, and 12 months time following criteria given by Ryge et al. All the results were analyzed by Statistical Package for the Social Sciences (SPSS) software. Mann-Whitney test and one-way analysis of variance (ANOVA) were used to evaluate the level of significance; p value less than 0.05 was considered as significant. For composite and RGIC restorations, the mean score for anatomic shape was 1.21 and 1.10 respectively. While comparing the clinical parameters, nonsignificant results were obtained between composite and RGIC restorative materials at 4-, 8-, and 12-month interval. On comparing the clinical parameters for individual restorative materials at different time intervals, statistically significant results were obtained only for

  20. Comparative evaluation of turmeric and chlorhexidine gluconate mouthwash in prevention of plaque formation and gingivitis: a clinical and microbiological study.

    PubMed

    Waghmare, P F; Chaudhari, A U; Karhadkar, V M; Jamkhande, A S

    2011-07-01

    To compare the efficacy of turmeric mouthwash and chlorhexidine gluconate mouthwash in prevention of gingivitis and plaque formation. A total of 100 randomly selected subjects visiting the Department of Periodontology at Bharati Vidyapeeth Deemed University, Dental College and Hospital, were considered for the study. The gingival index (GI) by Loe and Silness was recorded which was followed by Turesky- Gilmore-Glickman modification of Quigley Hein plaque index (TQHPI) at 0, 14 and 21 days. Individuals who gave an informed consent, subjects in the age group of 25 to 35 years with having fair and poor gingival index scores and a score >1 for plaque index, were included in the study. Results showed statistically significant reduction (p < 0.05) in mean plaque index (PI) with chlorhexidine gluconate mouthwash when compared with turmeric mouthwash. No significant difference in mean gingival index (GI) was seen when chlorhexidine mouthwash was compared with turmeric mouthwash. Significant reduction in total microbial count (p < 0.05) was observed in both the groups. No significant difference was observed in total microbial count when chlorhexidine mouthwash was compared with turmeric mouthwash. From the above observations, it can be concluded that chlorhexidine gluconate as well as turmeric mouthwash can be effectively used as an adjunct to mechanical plaque control methods in prevention of plaque and gingivitis. Chlorhexidine gluconate has been found to be more effective when antiplaque property was considered. From this study, it could be stated that turmeric is definitely a good adjunct to mechanical plaque control. Further studies are required on turmeric based mouthwash to establish it as a low cost plaque control measure.

  1. [Clinical evaluation of oxypertine in anxiety conditions].

    PubMed

    Somohano, M D; Broissin, M C; Sobrino Z, A

    1976-01-01

    Oxypertine, a new anxiolytic drug related to the indolylazine compounds, was evaluated in a group of 30 patients, the majority with severe anxiety (acute or chronic) : in some cases depression was associated. The study was performed in the Psychiatric Department at the Centro Femenil de Rehabilitación Social, in Mexico City. A special feature of this study was that patients were confined for a legal process and consequently with restricted liberty. All were females between 19 to 44 years old, with an average age of 32.05 years. The methodology applied in this case was a modified double blind randomized procedure, using different color capsules with placebo or the active drug (yellow oxypertine and blue placebo). Patients received a 10 mg capsule every 12 hours (20 mg daily). The clinical measurement of anxiety was performed using the Visual Anxiety Scale (Murphy), evaluating each of its 11 parameters. The intensity was qualified from 0 to 3; at the end of each consultation a global assessment was made. Most of the patients were interviewed in five occasions during the treatment period. For each of the nine patients receiving during 4 weeks only oxypertine capsules (group I), the scores of the parameters of the scale were added, observing the following results: in seven excellent respond, fair in one and one abandoned the study since the beginning. In eight of the patients who received placebo (group II) also for a 4 weeks period, results were evaluated as follows: five excellent one good and two poor. It can be observed that both groups gave a similar final score at the end of the study, meaning that no significant benefits were obtained between the active drug and the placebo, in spite that anxiety decreased in most of them. In group III, seven cases initiated with placebo and after 2 weeks the capsule had to be changed to oxypertine due to stablization or increase in the anxiety. Results were excellent in three, good in two, poor in one and another case

  2. Adsorption of 99mTc-Sestamibi onto Plastic Syringes: Evaluation of Factors Affecting the Degree of Adsorption and Their Impact on Clinical Studies*

    PubMed Central

    Swanson, Tiffinee N.; Troung, Duong T.; Paulsen, Andrew; Hruska, Carrie B.; O’Connor, Michael K.

    2014-01-01

    The purpose of this study was to document the extent of adhesion of 99mTc-sestamibi to syringes in patient procedures, determine factors that influence the degree of adhesion, and evaluate alternatives to our current practice that would either result in a more reproducible degree of adhesion or, ideally, eliminate adhesion. Methods The extent of adhesion was documented in 216 patient procedures and evaluated in detail in an additional 73 patient procedures. We evaluated the nature of the adhesion and its possible causes, including the location of adhesion in injection sets, the effect of syringe type, and the effect of prerinsing of syringes with various solutions of nonradiolabeled sestamibi and 99mTc-sestamibi. The extent of adhesion was reevaluated in 50 procedures performed using the syringe type that demonstrated the lowest adhesion rate. Results The degree of adhesion of 99mTc-sestamibi to the injection set was found to be 20.1% ± 8.0%, with a range (10th–90th percentiles) of 9%–31%. The primary cause of adhesion appeared to be the lubricant used inside the syringe barrel. Evaluation of 6 different syringe types identified a brand with a lower adhesion rate. Reevaluation in patient procedures using this brand showed a 5.2% ± 2.5% degree of adhesion, with a range (10th–90th percentiles) of 2.5%–7.7%. Conclusion Selection of the appropriate type of syringe can significantly reduce the magnitude and variability of residual 99mTc-sestamibi activity. With more reproducible residual activities, we have been able to achieve an approximately 20% reduction in the dispensed dose of 99mTc-sestamibi used in clinical procedures and a more consistent injected dose with less interpatient variation. The frequent changes in syringe design by manufacturers require that a quality control program for monitoring of residual activity be incorporated into clinical practice. This program has allowed us to maintain image quality and achieve more consistent injected patient

  3. Clinical evaluation of the electronic nose in the diagnosis of ear, nose and throat infection: a preliminary study.

    PubMed

    Shykhon, M E; Morgan, D W; Dutta, R; Hines, E L; Gardner, J W

    2004-09-01

    The term electronic nose describes an electronic system that is able to mimic the human sense of smell. Electronic noses have been developed over the last 10 or more years to perform a variety of identification tasks in various industries. More recently electronic noses have attracted new interest in their application in the field of medical diagnosis. The aim of this study is to explore the use of an electronic nose to identify and classify pathogens associated with ear, nose and throat (ENT) infections. In this study 90 bacterial swab samples were collected from 90 patients with ENT infections. Some of these samples were analysed immediately with a commercial electronic nose (Cyranose C320). Similar numbers of swabs were also taken from the same site of infection and were sent for microbiology culture and sensitivity. The electronic nose diagnosis was compared with the microbiology diagnosis and it was found that the electronic nose diagnosis was correct in 88.2 per cent of the cases, which is an encouraging result.

  4. A Correlative Classification Study of Schizophrenic Patients with Results of Clinical Evaluation and Structural Magnetic Resonance Images

    PubMed Central

    Chu, Wen-Lin; Jian, Bo-Lin; Hsu, Chih-Yao

    2016-01-01

    Patients with schizophrenia suffer from symptoms such as hallucination and delusion. There are currently a number of publications that discuss the treatment, diagnosis, prognosis, and damage in schizophrenia. This study utilized joint independent component analysis to process the images of GMV and WMV and incorporated the Wisconsin card sorting test (WCST) and the positive and negative syndrome scale (PANSS) to examine the correlation of obtained brain characteristics. We also used PANSS score to classify schizophrenic patients into acute and subacute cases, to analyze the brain structure differences. Finally, we used brain structure images and the error rate of the WCST as eigenvalues in support vector machine learning and classification. The results of this study showed that the frontal and temporal lobes of a normal brain are more apparent than those of a schizophrenia brain. The highest level of classification recognition reached 91.575%, indicating that the WCST error rate and characteristic changes in brain structure volume can be used to effectively distinguish schizophrenia and normal brains. Similarly, this result confirmed that the WCST and brain structure volume are correlated with the differences between schizophrenia and normal participants. PMID:27843197

  5. [Evaluation of the safety of antitussive agents during respiratory rehabilitation. A clinical study of L-dropropizine].

    PubMed

    Bejor, M; Arrigo, A

    1990-06-30

    This study proves that L-dropropizine, a new peripheral antitussive drug, does not hinder the positive and useful effect of cough. This is particularly the case of physiokinesis in chronic obstructive lung disease patients. To quantify results, the respiratory voluntary muscles have been examined by surface electromyography and the peak expiratory flow has been registered by a computer-assisted device. By analysing the curves obtained relating the intensity of muscle contraction to expiratory flow, i.e. the muscle work exerted, no difference has been found after L-dropropizine and placebo. Statistical analysis evidenced increase in maximal peak expiratory flow and decrease in muscle work with both therapies. Both were significant (Student's test for paired data: p less than 0.01) in attaining functional improvement. Levodropropizine does not seem to impair the efficacy of cough elicited as part of respiratory clearance mechanisms.

  6. Radiographic Evaluation of Crestal Bone Loss Around Dental Implants in Maxilla and Mandible: One Year Prospective Clinical Study

    PubMed Central

    Ajanović, Muhamed; Hamzić, Adis; Redžepagić, Sead; Kamber-Ćesir, Alma; Tosum, Selma

    2015-01-01

    Purpose The aim of the study was to analyze the amount of maxillary and mandibular crestal bone loss around Bredent Sky Blue type of implants of different dimensions one year after implantation. Materials and Methods 36 implants of diameter 3.5 x 10 mm were inserted in the maxilla and 12 in the mandible. 52 implants of diameter 4.0 x 8 mm were inserted in the maxilla, and 61 in the mandible (two-stage implant surgery). Results No statistically significant differences were found between the right and left side of the maxilla and between the right and left side of the mandible at the implant sites regarding distal and mesial bone losses as shown by analysis of variance (ANOVA). Conclusion Statistically significant differences were found between anterior maxilla, posterior maxilla and anterior mandible and posterior mandible at implant sites regarding distal and mesial bone losses as shown by analysis of variance (ANOVA). PMID:27688395

  7. A national evaluation of specialists' clinics in primary care settings.

    PubMed Central

    Bowling, A; Bond, M

    2001-01-01

    BACKGROUND: Encouraged by the increased purchasing power of general practitioners (GPs), specialist-run clinics in general practice and community health care settings (known as specialist outreach clinics) have increased rapidly across England. The activities of local commissioning schemes within primary care groups are likely to accelerate this trend. AIM: To evaluate the costs, processes, and benefits of specialists' outreach clinics held in GPs' surgeries, compared with hospital outpatient clinics. DESIGN OF STUDY: A case-referent (comparative) study comparing the characteristics of outreach clinics (cases) with matched outpatient control clinics. SETTING: Thirty-eight outreach clinics, compared with 38 matched outpatient clinics as controls, covering 14 hospital trust areas across England. METHOD: Self-administered questionnaires were given to patients in both clinic settings. These covered processes, satisfaction, personal costs, and health status, with postal follow-up at six months to assess health outcomes. Self-administered questionnaires were also given to the specialists and GPs whose clinics were included in the study (individual patient clinical sheet and an attitude questionnaire), practice managers, and trust accountants (process and costs questionnaire). Evaluation of the costs, processes, and benefits of specialist outreach clinics versus hospital outpatient clinics was carried out by comparing questionnaire responses. RESULTS: In comparison with outpatients, outreach clinic patients spent less time on the waiting lists for appointments to see the specialist, they had shorter waiting times in clinics, fewer follow-up appointments, and were more likely to be completely discharged after the sampled attendance. Outreach patients were more satisfied than outpatients with the range of clinic process items asked about. Most doctors felt that the outreach clinic was 'worthwhile'. While patients' personal costs were lower in outreach than in outpatients

  8. Efficacy of sealing proximal early active lesions: an 18-month clinical study evaluated by conventional and subtraction radiography.

    PubMed

    Martignon, S; Ekstrand, K R; Ellwood, R

    2006-01-01

    This study assessed the efficacy of sealing proximal lesions on adult patients using a split-mouth design. Eighty-two 15- to 39-year-olds from the Dental Faculties in Copenhagen and Bogotá participated, each having 2 or more proximal lesions in the following radiographic stages: (1) lesion restricted to the outer half of enamel; (2) lesion from the inner half of enamel including the enamel dentine junction, and (3) lesion restricted to the outer third of dentine. Standardized geometrically aligned baseline and follow-up radiographs were obtained. One randomly selected lesion (test) in each patient was sealed with 1 of 2 resins. The patients were instructed to floss all the proximal lesions 3 times per week. The baseline to 18 months difference in caries lesion progression status was assessed using 3 methods: (1) radiographs were independently assessed visually; (2) radiographs were read in pairs, and (3) using subtraction radiography of digitized images. A total of 72 subjects finished the study (12.2% dropout). The compliance concerning flossing was poor (15%). For the repeated examinations kappa was 0.84 for the visual examination, 0.44 for the paired readings and 0.84 for the subtraction examination. Two test lesions and 1 control lesion were restored. For the independent radiograph assessment method 10 and 26% progressed in the test and control group, respectively (p > 0.05); with the paired radiograph method the corresponding data were 22% in the test and 47% in the control groups (p < 0.01). By subtraction radiography 44% of the test group and 84% of the control were judged to have progressed (p < 0.001). The sealing technique was superior to instructing patients to floss, and subtraction radiography appeared to be the most sensitive method for assessing lesion progression. Copyright 2006 S. Karger AG, Basel.

  9. Instructional Scaffolding to Improve Students’ Skills in Evaluating Clinical Literature

    PubMed Central

    Dominguez, Karen D.; Troutman, William G.; Bond, Rucha; Cone, Catherine

    2011-01-01

    Objective To implement and assess the effectiveness of an activity to teach pharmacy students to critically evaluate clinical literature using instructional scaffolding and a Clinical Trial Evaluation Rubric. Design The literature evaluation activity centered on a single clinical research article and involved individual, small group, and large group instruction, with carefully structured, evidence-based scaffolds and support materials centered around 3 educational themes: (1) the reader's awareness of text organization, (2) contextual/background information and vocabulary, and (3) questioning, prompting, and self-monitoring (metacognition). Assessment Students initially read the article, scored it using the rubric, and wrote an evaluation. Students then worked individually using a worksheet to identify and define 4 to 5 vocabulary/concept knowledge gaps. They then worked in small groups and as a class to further improve their skills. Finally, they assessed the same article using the rubric and writing a second evaluation. Students’ rubric scores for the article decreased significantly from a mean pre-activity score of 76.7% to a post-activity score of 61.7%, indicating that their skills in identifying weaknesses in the article's study design had improved. Conclusion Use of instructional scaffolding in the form of vocabulary supports and the Clinical Trial Evaluation Rubric improved students’ ability to critically evaluate a clinical study compared to lecture-based coursework alone. PMID:21769138

  10. Clinical evaluation of seven anticalculus dentifrice formulations.

    PubMed

    Scruggs, R R; Stewart, P W; Samuels, M S; Stamm, J W

    1991-01-01

    One hundred ninety-two subjects completed a clinical trial to determine the effects of seven dentifrice formulations on calculus inhibition. The double-blind study involved a ten-day control phase and a ten-day experimental phase. For the control phase, subjects were evaluated for calculus present, received a prophylaxis and had pre-weighed mylar strips attached to the lingual surfaces of the mandibular incisors to harvest mineral deposits. Subjects were then assigned the placebo dentifrice for unsupervised twice-daily use and were required to report once a day for a supervised mouthrinse using a 1:3 dilution of the dentrifice. The experimental phase was identical except that subjects were allocated the experimental dentifices using a stratified random assignment based on age, gender and the initial presence of calculus. Simple linear regression analyses of the dry and ash log weights obtained from the strips were performed. The results showed no statistically significant differences among the test products; however, two formulations containing zinc citrate showed some calculus inhibition-potential suggesting that further research and development of such products may be warranted.

  11. [Elaboration and critical evaluation of clinical guidelines].

    PubMed

    García Villar, C

    2015-11-01

    Clinical guidelines are documents to help professionals and patients select the best diagnostic or therapeutic option. Elaborating guidelines requires an efficient literature search and a critical evaluation of the articles found to select the most appropriate ones. After that, the recommendations are formulated and then must be externally evaluated before they can be disseminated. Even when the guidelines are very thorough and rigorous, it is important to know whether they fulfill all the methodological requisites before applying them. With this aim, various scales have been developed to critically appraise guidelines. Of these, the AGREE II instrument is currently the most widely used. This article explains the main steps in elaborating clinical guidelines and the main aspects that should be analyzed to know whether the guidelines are well written.

  12. Evaluating clinical dermatology practice in medical undergraduates.

    PubMed

    Casanova, J M; Sanmartín, V; Martí, R M; Morales, J L; Soler, J; Purroy, F; Pujol, R

    2014-06-01

    The acquisition of competences (the set of knowledge, skills and attitudes required to perform a job to a professional level) is considered a fundamental part of medical training. Dermatology competences should include, in addition to effective clinical interviewing and detailed descriptions of skin lesions, appropriate management (diagnosis, differentiation, and treatment) of common skin disorders and tumors. Such competences can only be acquired during hospital clerkships. As a way of certifying these competences, we propose evaluating the different components as follows: knowledge, via clinical examinations or critical incident discussions; communication and certain instrumental skills, via structured workplace observation and scoring using a set of indicators; and attitudes, via joint evaluation by staff familiar with the student. Copyright © 2012 Elsevier España, S.L. and AEDV. All rights reserved.

  13. A validation study to find highly correlated parameters with visual assessment for clinical evaluation of cosmetic anti-cellulite products.

    PubMed

    Yoo, Mi Ae; Seo, Young Kyoung; Ryu, Ja Hyun; Back, Ji Hwoon; Koh, Jae Sook

    2014-05-01

    There has been growing interest in cellulite on parts of the body; however, no objective assessment has been specifically established. This study aims to demonstrate an optimized method by comparing the existing assessments of cellulite. In Test 1, for subjects of 20 healthy females who have cellulite, we measured volume and roughness of cellulite using fringe projection method, roughness using replica method, dermo-subcutaneous interface length and subcutaneous thickness using ultrasonography and skin temperature using infrared ray, elasticity and blood flow. In Test 2, we applied an anti-cellulite cosmetic to 28 subjects for 6 weeks and observed if they have any changes. In Test 1, the effective parameter that is the most correlated with visual assessment was volume of skin measured using fringe projection method (r = 0.780). Dermo-subcutaneous interface length (r = 0.355) and subcutaneous thickness (r = 0.502) measured using ultrasonography followed in order. In Test 2, after applying a tested product, the correlation coefficient of volume of skin, of dermo-subcutaneous interface length and of subcutaneous thickness are 0.409 (P = 0.000), 0.275 (P = 0.016) and 0.311 (P = 0.012) respectively. We conclude that visual assessment, volume of skin (cavities), dermo-subcutaneous interface length and subcutaneous thickness are optimized methods for assessing an effect of cosmetics on cellulite. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  14. OA01.40. A clinical study to evaluate the efficacy of leech therapy and panchatikta ghrita in the management of psoriasis)

    PubMed Central

    Gond, Pushpa; Rani, Rekha; Shringi, M. K.

    2012-01-01

    Purpose: Modern medical science treats psoriasis with PUVA, corticosteroid, anti-mitotic drugs which gives serious side effects like liver and kindney failure etc. There is a need to discover safe and effective medicine without any side effects for Psoriasis and the role of Leech Therapy (Shodhan) and Panchatikta Ghrita (Shaman Karma) is evaluated in this study. Method: 30 patients were included who matched the clinical signs and symptoms of psoriasis. These patients were randomised into three groups. Group A Only on leech therapy, Group B-Only on panchatikta ghrita and Group C On both leech therapy and panchatikta ghrita Result: Group A showed 45% improvement and group B showed 47% improvement, while group C reported 65% improvement. Conclusion: It can be concluded that shodan(leech application) along with shaman (panchatikta ghrita) is effective in the management of psoriasis as it is safe, cost effective and free from any side effects.

  15. Ultrareliable PACS: design and clinical evaluation

    NASA Astrophysics Data System (ADS)

    Goble, John C.; Kronander, Torbjorn; Wilske, Nils-Olof; Yngvesson, Jonas T.; Ejderholm, Henrik; Ekstrom, Marie

    1999-07-01

    We describe our experience in the design, installation and clinical evaluation o fan ultra-reliable PACS - a system in which the fundamental design constraint was system availability. This syste has ben constructed using commercial, off-the-shelf hardware and software, using an open system, standards-based approach. The system is deployed in the film-free Department of Pediatric Radiology at the Astrid Lindgren Barnsjukhus a nit of the Karolinska Institute in Stockholm, Sweden.

  16. Evaluation of C-reactive protein as a clinical biomarker in naturally heartworm-infected dogs: a field study.

    PubMed

    Venco, Luigi; Bertazzolo, Walter; Giordano, Guglielmo; Paltrinieri, Saverio

    2014-11-15

    Canine heartworm disease caused by Dirofilaria immitis is considered a pulmonary disease, which leads to pulmonary hypertension, and in the late stage, may induce right cardiac insufficiency. Adult worms are localized in the pulmonary arteries, which undergo endothelial damage (proliferative endoarteritis), the severity of which depends on the duration of infection and the worm burden. C-reactive protein (CRP) is a major canine acute-phase protein that rapidly increases in a wide range of inflammatory conditions and rapidly decreases when inflammation resolves. CRP is therefore considered a sensitive but nonspecific marker of inflammation. Pulmonary arterial damage in canine heartworm may induce an increase in CRP concentrations similar to what occurs in humans with endoarteritis. The aim of the present study was to investigate whether CRP may be a diagnostic and/or prognostic marker in canine heartworm, whether it may be used for staging and monitoring canine heartworm, and whether its concentration depends on worm burden or on pulmonary arterial damage. Serum CRP concentrations were determined in 57 dogs with heartworm disease, 47 of which were grouped according to parasite burden (low: n=11; high: n=10) or on severity of pulmonary hypertension (mild: n=16; severe: n=10). An additional 23 heartworm-free cardiopathic dogs were grouped on the absence of pulmonary hypertension (n=8), presence of dilated cardiomyopathy (DCM) (n=6), or presence of cardiomyopathy and pulmonary hypertension (n=3) due to previous heartworm disease that had been treated (n=6). Twenty control dogs also were sampled for CRP concentrations. Results show that CRP was significantly increased (p<0.001) in dogs with heartworm or cardiomyopathy compared with concentrations in controls. In the heartworm group, CRP was significantly increased (p<0.001) in dogs with mild or severe pulmonary hypertension but not in dogs with low or high parasite burden without pulmonary hypertension. Heartworm

  17. The SPIRIT V study: a clinical evaluation of the XIENCE V everolimus-eluting coronary stent system in the treatment of patients with de novo coronary artery lesions.

    PubMed

    Grube, Eberhard; Chevalier, Bernard; Smits, Peter; Džavík, Vladimir; Patel, Tejas M; Mullasari, Ajit S; Wöhrle, Jochen; Stuteville, Marrianne; Dorange, Cécile; Kaul, Upendra

    2011-02-01

    The SPIRIT V (A Clinical Evaluation of the XIENCE V Everolimus-Eluting Coronary Stent System in the Treatment of Patients With De Novo Coronary Artery Lesions) study is a post-market surveillance experience of the XIENCE V (Abbott Vascular, Santa Clara, California) everolimus-eluting stent (EES) in patients with higher-risk coronary anatomy. Previous pre-approval studies have shown the safety and efficacy of EES in highly selected groups of patients. The SPIRIT V trial is a prospective, open label, single arm, multicenter study. Two thousand seven hundred patients with multiple de novo coronary artery lesions suitable for treatment with a planned maximum of 4 EES were enrolled at 93 centers in Europe, Asia Pacific, Canada, and South Africa. Lesions had a reference vessel diameter between 2.25 and 4.0 mm and a length of ≤ 28 mm by visual estimation. An independent clinical events committee adjudicated all end point-related events. The primary end point was the composite rate of all death, myocardial infarction (MI), and target vessel revascularization at 30 days. Secondary end points included stent thrombosis and acute success (clinical device and procedure success). At 30 days, the primary composite end point of all death, MI, and target vessel revascularization was 2.7%. At 1 year, rates of cardiac death, overall MI, and target lesion revascularization were 1.1%, 3.5%, and 1.8%, respectively. The cumulative rate of definite and probable stent thrombosis was low at 0.66% at 1 year. Use of EES in patients with multiple, complex de novo lesions yielded 1-year major adverse cardiac events, stent thrombosis, and target lesion revascularization rates that are comparable to those of the more controlled SPIRIT II and SPIRIT III trials-which included patients with restricted inclusion/exclusion criteria-and other all-comer population, physician-initiated studies like the X-SEARCH (Xience Stent Evaluated At Rotterdam Cardiology Hospital) and COMPARE (A Randomized

  18. A national evaluation of specialists' clinics in primary care settings.

    PubMed

    Bowling, A; Bond, M

    2001-04-01

    Encouraged by the increased purchasing power of general practitioners (GPs), specialist-run clinics in general practice and community health care settings (known as specialist outreach clinics) have increased rapidly across England. The activities of local commissioning schemes within primary care groups are likely to accelerate this trend. To evaluate the costs, processes, and benefits of specialists' outreach clinics held in GPs' surgeries, compared with hospital outpatient clinics. A case-referent (comparative) study comparing the characteristics of outreach clinics (cases) with matched outpatient control clinics. Thirty-eight outreach clinics, compared with 38 matched outpatient clinics as controls, covering 14 hospital trust areas across England. Self-administered questionnaires were given to patients in both clinic settings. These covered processes, satisfaction, personal costs, and health status, with postal follow-up at six months to assess health outcomes. Self-administered questionnaires were also given to the specialists and GPs whose clinics were included in the study (individual patient clinical sheet and an attitude questionnaire), practice managers, and trust accountants (process and costs questionnaire). Evaluation of the costs, processes, and benefits of specialist outreach clinics versus hospital outpatient clinics was carried out by comparing questionnaire responses. In comparison with outpatients, outreach clinic patients spent less time on the waiting lists for appointments to see the specialist, they had shorter waiting times in clinics, fewer follow-up appointments, and were more likely to be completely discharged after the sampled attendance. Outreach patients were more satisfied than outpatients with the range of clinic process items asked about. Most doctors felt that the outreach clinic was 'worthwhile'. While patients' personal costs were lower in outreach than in outpatients clinics, NHS costs were more expensive per patient in outreach

  19. Histopathological and clinical evaluation of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rats: an experimental study

    PubMed Central

    2013-01-01

    Background Kombucha, a fermented tea (KT) is claimed to possess many beneficial properties. The aim of this study was to evaluate clinical and histopathological alterations of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rat. Methods In present study 24 Wister -albino rats weighing 150–200 g were selected and divided to two treatment groups as Nitrofurazone ointment (0.2%) and Kombucha tea. Subsequently, the anesthesia was exerted by Ketamin hydrochloride 10% (40 mg/kg) and Xylasine (2 mg/kg) through intra muscular (IM) route. Furthermore, upon preparation of dorsal region of the animal for surgery, a piece of full-thickness skin removed (2 × 2 cm). In order to comparing wounds healing clinically and histologically, once every four days from the commencement, the wounds were photographed and the healed surface was measured by Scion image software. Result The clinical findings indicated that the Kombucha fungus resulted in precipitating healing than Nitrofurazone; however, it was not significant (p > 0.05). In order to pathological comparing of wound healing process, several wound biopsies were taken on 4, 8, 12, 16 and 20th days. Additionally, the histopathological results demonstrated that there was inflammation in Nitrofurazone group through twelveth day, somehow the epithelium was formed and abundant vessels were visible. Although on 16th day and the previous days the healing condition of Kombucha fungus was considered as minimal rate, revealing it is similar to Nitrofurazone group on 20th day. Conclusions To wrap up. These observations suggest that the Kombucha fungus healing quality was rapid from 12th day to the end of the research, whereas no significant difference was observed. Virtual slide The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1107407136102196 PMID:23866960

  20. Histopathological and clinical evaluation of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rats: an experimental study.

    PubMed

    Barati, Fardin; Javanbakht, Javad; Adib-Hashemi, Farajollah; Hosseini, Ehsan; Safaeie, Reyhaneh; Rajabian, Mojtaba; Razmjoo, Mostafa; Sedaghat, Reza; Aghamohammad Hassan, Mehdi

    2013-07-17

    Kombucha, a fermented tea (KT) is claimed to possess many beneficial properties. The aim of this study was to evaluate clinical and histopathological alterations of Kombucha tea and Nitrofurazone on cutaneous full-thickness wounds healing in rat. In present study 24 Wister -albino rats weighing 150-200 g were selected and divided to two treatment groups as Nitrofurazone ointment (0.2%) and Kombucha tea. Subsequently, the anesthesia was exerted by Ketamin hydrochloride 10% (40 mg/kg) and Xylasine (2 mg/kg) through intra muscular (IM) route. Furthermore, upon preparation of dorsal region of the animal for surgery, a piece of full-thickness skin removed (2 × 2 cm). In order to comparing wounds healing clinically and histologically, once every four days from the commencement, the wounds were photographed and the healed surface was measured by Scion image software. The clinical findings indicated that the Kombucha fungus resulted in precipitating healing than Nitrofurazone; however, it was not significant (p > 0.05). In order to pathological comparing of wound healing process, several wound biopsies were taken on 4, 8, 12, 16 and 20th days. Additionally, the histopathological results demonstrated that there was inflammation in Nitrofurazone group through twelveth day, somehow the epithelium was formed and abundant vessels were visible. Although on 16th day and the previous days the healing condition of Kombucha fungus was considered as minimal rate, revealing it is similar to Nitrofurazone group on 20th day. To wrap up. These observations suggest that the Kombucha fungus healing quality was rapid from 12th day to the end of the research, whereas no significant difference was observed. The virtual slide(s) for this article can be found here: http://www.diagnosticpathology.diagnomx.eu/vs/1107407136102196.

  1. Value of quantitative MRI parameters in predicting and evaluating clinical outcome in conservatively treated patients with chronic midportion Achilles tendinopathy: A prospective study.

    PubMed

    Tsehaie, J; Poot, D H J; Oei, E H G; Verhaar, J A N; de Vos, R J

    2017-07-01

    To evaluate whether baseline MRI parameters provide prognostic value for clinical outcome, and to study correlation between MRI parameters and clinical outcome. Observational prospective cohort study. Patients with chronic midportion Achilles tendinopathy were included and performed a 16-week eccentric calf-muscle exercise program. Outcome measurements were the validated Victorian Institute of Sports Assessment-Achilles (VISA-A) questionnaire and MRI parameters at baseline and after 24 weeks. The following MRI parameters were assessed: tendon volume (Volume), tendon maximum cross-sectional area (CSA), tendon maximum anterior-posterior diameter (AP), and signal intensity (SI). Intra-class correlation coefficients (ICCs) and minimum detectable changes (MDCs) for each parameter were established in a reliability analysis. Twenty-five patients were included and complete follow-up was achieved in 20 patients. The average VISA-A scores increased significantly with 12.3 points (27.6%). The reliability was fair-good for all MRI-parameters with ICCs>0.50. Average tendon volume and CSA decreased significantly with 0.28cm(3) (5.2%) and 4.52mm(2) (4.6%) respectively. Other MRI parameters did not change significantly. None of the baseline MRI parameters were univariately associated with VISA-A change after 24 weeks. MRI SI increase over 24 weeks was positively correlated with the VISA-A score improvement (B=0.7, R(2)=0.490, p=0.02). Tendon volume and CSA decreased significantly after 24 weeks of conservative treatment. As these differences were within the MDC limits, they could be a result of a measurement error. Furthermore, MRI parameters at baseline did not predict the change in symptoms, and therefore have no added value in providing a prognosis in daily clinical practice. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  2. Design of appointment systems for preanesthesia evaluation clinics to minimize patient waiting times: a review of computer simulation and patient survey studies.

    PubMed

    Dexter, F

    1999-10-01

    Anesthesiologists can use the science of clinic scheduling to design appointment systems for preanesthesia evaluation clinics. The principal reasons reported for inappropriately [or arguably unethically] long patient waiting times are provider tardiness, lack of patient punctuality, patient no-shows, and improperly designed appointment systems. However, the fundamental reason why anesthesia clinics have such long patient waiting times is because of their relatively long mean (and consequently standard deviation) of consultation times. If commonly applied valuations of provider idle time to patient waiting time are used in anesthesia clinics, appointment intervals will be sufficiently brief that the mean patient waiting time will be at least the mean consultation time or half an hour. Patients will be dissatisfied with this level of service. Therefore, efforts to decrease the mean patient waiting time in anesthesia clinics should focus foremost on minimizing the mean consultation time and its variability, which can most likely be achieved by assuring that providers have rapid access to relevant clinical information, including external medical records, surgical dictations, etc. Anesthesiologists managing anesthesia clinics may find it valuable to apply other interventions to decrease patient waiting times. Scheduling of preanesthesia evaluation and surgical clinics should be coordinated to assure patient punctuality. Providers should be on time for the start of their sessions. If an add-on patient cannot be seen during a scheduled clinic session, because all appointment times have been assigned to other patients, the add-on patient should be seen by a different provider or at the end of the regularly scheduled clinic session. Mean consultation times should be measured accurately for each provider. Substantial provider idle time should be expected. Appropriate values for breaks, appointment intervals, and percentage no-shows should be determined by computer simulation

  3. Evaluation of different systems for clinical quantification of varicose veins.

    PubMed

    Cornu-Thénard, A; De Vincenzi, I; Maraval, M

    1991-04-01

    One hundred twenty-five lower limbs with varicose veins were studied clinically, essentially by palpation. Two specialists in venous pathology scored the severity of the varicose veins from 0 to 20. Comparison between the different clinical parameters and the scores of the specialists showed that two systems of clinical quantification gave good results and were easy to use. One system is the maximum diameter of the largest varicose vein; the other system is the sum of maximum diameters over 7 sections (3 for thigh, 3 for leg, 1 for foot). This latter system gives a more precise evaluation of the clinical severity of the varicose veins.

  4. Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits.

    PubMed

    Koo, Bon-Min; Kim, Jang-Ho Jay; Kim, Tae-Kyun; Kim, Byung-Yun

    2015-09-17

    In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder). To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability.

  5. EARLIER: an observational study to evaluate the use of cinacalcet in incident hemodialysis patients with secondary hyperparathyroidism in daily clinical practice.

    PubMed

    Hemetsberger, Margit; Oberbauer, Rainer; Erb, Helmut; Pronai, Wolfgang

    2015-10-01

    The EARLIER (Evaluation of MimpARa in incident hemodiaLysis patIEnts with secondaRy hyperparathyroidism; SHPT) observational postmarketing surveillance study evaluated incident hemodialysis patients (< 1 year dialysis vintage; n = 146) receiving cinacalcet in Austrian clinical practice. Despite intervention with vitamin D sterols and phosphate binders, 24 % had already developed severe SHPT (intact parathyroid hormone (iPTH) > 800 pg/mL) at baseline. After cinacalcet was started, median iPTH decreased substantially, from 611 pg/mL to 251 pg/mL (median decrease 58 % [IQR - 36 to - 78 %] at 12 months. Overall, 36 % of patients achieved the Kidney Disease Outcomes Quality Initiative (K/DOQI) target range (150-300 pg/mL) for iPTH; this included 35 % of those with severe SHPT at baseline. Serum phosphorus (P), calcium (Ca) (corr), and Ca (corr) × P also decreased, with 43, 34, and 62 % of patients, respectively, reaching K/DOQI targets at 12 months. Thus, in this observational study, mineral metabolism in incident dialysis patients with SHPT improved after starting cinacalcet.

  6. Material Performance and Animal Clinical Studies on Performance-Optimized Hwangtoh Mixed Mortar and Concrete to Evaluate Their Mechanical Properties and Health Benefits

    PubMed Central

    Koo, Bon-Min; Kim, Jang-Ho Jay; Kim, Tae-Kyun; Kim, Byung-Yun

    2015-01-01

    In this study, the amount of cement used in a concrete mix is minimized to reduce the toxic effects on users by adjusting the concrete mixture contents. The reduction of cement is achieved by using various admixtures (ground granulated blast-furnace slag, flyash, ordinary Portland cement, and activated Hwangtoh powder). To apply the mix to construction, material property tests such as compressive strength, slump, and pH are performed. Preliminary experimental results showed that the Hwangtoh concrete could be used as a healthy construction material. Also, the health issues and effects of Hwangtoh mortar are quantitatively evaluated through an animal clinical test. Mice are placed in Hwangtoh mortar and cement mortar cages to record their activity. For the test, five cages are made with Hwangtoh and ordinary Portland cement mortar floors, using Hwangtoh powder replacement ratios of 20%, 40%, 60%, and 80% of the normal cement mortar mixing ratio, and two cages are made with Hwangtoh mortar living quarters. The activity parameter measurements included weight, food intake, water intake, residential space selection, breeding activity, and aggression. The study results can be used to evaluate the benefits of using Hwangtoh as a cement replacing admixture for lifestyle, health and sustainability. PMID:28793563

  7. [Clinical research III. The causality studies].

    PubMed

    Talavera, Juan O; Wacher-Rodarte, Niels H; Rivas-Ruiz, Rodolfo

    2011-01-01

    The need to solve a clinical problem leads us to establish a starting point to address (risk, prognosis or treatment studies), all these cases seek to attribute causality. Clinical reasoning described in the book Clinical Epidemiology. The architecture of clinical research, offers a simple guide to understanding this phenomenon. And proposes three basic components: baseline, maneuver and outcome. In this model, different systematic errors (bias) are described, which may be favored by omitting characteristics of the three basic components. Thus, omissions in the baseline characteristics cause an improper assembly of the population and susceptibility bias, omissions in the application or evaluation of the maneuver provoke performance bias, and omissions in the assessment of out-come cause detection bias and transfer bias. Importantly, if this way of thinking facilitates understanding of the causal phenomenon, the appropriateness of the variables to be selected in the studies to which attribute or not causality, require additional arguments for evaluate clinical relevance.

  8. Evaluation of pre-existing antibody presence as a risk factor for posttreatment anti-drug antibody induction: analysis of human clinical study data for multiple biotherapeutics.

    PubMed

    Xue, Li; Rup, Bonita

    2013-07-01

    Biotherapeutic-reactive antibodies in treatment-naïve subjects (i.e., pre-existing antibodies) have been commonly detected during clinical immunogenicity assessments; however information on pre-existing antibody prevalence, physiological effects, and impact on posttreatment anti-drug antibody (ADA) induction remains limited. In this analysis, pre-existing antibody prevalence and impact on posttreatment ADA induction were determined using ADA data from 12 biotherapeutics analyzed in 32 clinical studies. Approximately half (58%) of the biotherapeutics were associated with some level of pre-existing antibodies and 67% of those were associated with posttreatment ADA induction. Across all studies, 5.6% of study subjects demonstrated presence of pre-existing antibodies, among which, 17% of the individual subjects had posttreatment increases in their ADA titers while 16% had decreased titers and 67% had no change in titers. However, in studies conducted in the rheumatoid arthritis (RA) population, 14.8% of RA patients were associated with pre-existing antibodies and 30% of those had posttreatment titer increases. The results suggest that in most study subjects, pre-existing antibodies pose a low risk for posttreatment ADA induction. That said, the high risk of induction implicated for RA patients, primarily observed in treatments evaluating novel antibody-based constructs, indicates that further understanding of the contribution of product and disease-specific factors is needed. Cross-industry efforts to collect and analyze a larger data set would enhance understanding of the prevalence, nature, and physiological consequences of pre-existing antibodies, better inform the immunogenicity risk profiles of products associated with these antibodies and lead to better fit-for-purpose immunogenicity management and mitigation strategies.

  9. Clinical competency evaluation of Brazilian chiropractic interns

    PubMed Central

    Facchinato, Ana Paula A.; Benedicto, Camila C.; Mora, Aline G.; Cabral, Dayane M.C.; Fagundes, Djalma J.

    2015-01-01

    Objective This study compares the results of an objective structured clinical examination (OSCE) between 2 groups of students before an internship and after 6 months of clinical practice in an internship. Methods Seventy-two students participated, with 36 students in each cohort. The OSCEs were performed in the simulation laboratory before the participants' clinical practice internship and after 6 months of the internship. Students were tested in 9 stations for clinical skills and knowledge. The same procedures were repeated for both cohorts. The t test was used for unpaired parametric samples and Fisher's exact test was used for comparison of proportions. Results There was no difference in the mean final score between the 2 groups (p = .34 for test 1; p = .08 for test 2). The performance of the students in group 1 was not significantly different when performed before and after 6 months of clinical practice, but in group 2 there was a significant decrease in the average score after 6 months of clinical practice. Conclusions There was no difference in the cumulative average score for the 2 groups before and after 6 months of clinical practice in the internship. There were differences within the cohorts, however, with a significant decrease in the average score in group 2. Issues pertaining to test standardization and student motivation for test 2 may have influenced the scores. PMID:25588200

  10. Chlamydia antibodies, chlamydia heat shock protein, and adverse sequelae after pelvic inflammatory disease: the PID Evaluation and Clinical Health (PEACH) Study.

    PubMed

    Ness, Roberta B; Soper, David E; Richter, Holly E; Randall, Hugh; Peipert, Jeffrey F; Nelson, Deborah B; Schubeck, Diane; McNeeley, S Gene; Trout, Wayne; Bass, Debra C; Hutchison, Katherine; Kip, Kevin; Brunham, Robert C

    2008-02-01

    Among women with pelvic inflammatory disease (PID), we assessed the associations among antibodies to Chlamydia trachomatis elementary bodies (EB), antibodies to chlamydia heat shock protein (Chsp60), rates of pregnancy, and PID recurrence. Four hundred forty-three women with clinical signs and symptoms of mild to moderate PID enrolled in the PID Evaluation and Clinical Health Study were followed for a mean of 84 months for outcomes of time-to-pregnancy and time-to-PID recurrence. Antibodies to EB and Chsp60 were assessed in relation to these long-term sequelae of PID. Rates of pregnancy were significantly lower (adj. hazard ratio 0.47, 95% confidence interval 0.28-0.79) and PID recurrence higher (adj. hazard ratio 2.48, 95% confidence interval 1.00-6.27) after adjusting for confounding factors among women whose antibody titers to chlamydia EB measured in the final year of follow-up were in the highest tertile. Among women with mild to moderate PID, antibodies to C. trachomatis were independently associated with reduced rates of pregnancy and elevated rates of recurrent PID.

  11. OA03.07. A comparative clinical study to evaluate the therapeutic effect of shivagutika in patients with H.I.V infection

    PubMed Central

    Anil, L Abhishek; Acharya, G Shrinivasa

    2013-01-01

    Purpose: HIVAIDS is the most dreaded challenge that the today's medical world is facing! As patients do not have many options, they tend to look at ayurveda to help improve their condition clinical presentation of HIV is akin to the description of Rajayakshma characterized by involvement of multiple srotas and presenting with diarrhea, cough, fever and similar other symptoms. Shiva guttika is used here as a rasayana to improve the immunity. Method: A Single blind comparative clinical study with Pretest & Post test design. The patients were randomly categorized into two groups as shivagutika group and ART group consisting of 20 patients each Shivagutika group In this group the 20 patients were treated orally with shivagutika in a dose of 12 grams od, for 6 months ART group In this the patients were treated with ART for six months. Result: The criteria's selected for the evaluation like Cough, Dyspnoea, fever,body weight, HB%, ESR, CD4 count etc all were statistically analyzed. Following medication with shivagutika the value of cd4 count was 567 in comparison to initial value of 391. in the ART group the initial value of 417.6 increased to 447.6 following treatment. Conclusion: CD4 count affirms the therapeutic benefit of shivagutika in HIV infection /AIDS beyond doubt Various other vyadhi hara rasayanas can be used in the management of immuno compromised conditions and in reoccurant diseases.

  12. Use of 3×2 tables with an intention to diagnose approach to assess clinical performance of diagnostic tests: meta-analytical evaluation of coronary CT angiography studies

    PubMed Central

    Schuetz, Georg M; Schlattmann, Peter

    2012-01-01

    Objective To determine whether a 3×2 table, using an intention to diagnose approach, is better than the “classic” 2×2 table at handling transparent reporting and non-evaluable results, when assessing the accuracy of a diagnostic test. Design Based on a systematic search for diagnostic accuracy studies of coronary computed tomography (CT) angiography, full texts of relevant studies were evaluated to determine whether they could calculate an alternative 3×2 table. To quantify an overall effect, we pooled diagnostic accuracy values according to a meta-analytical approach. Data sources Medline (via PubMed), Embase (via Ovid), and ISI Web of Science electronic databases. Eligibility criteria Prospective English or German language studies comparing coronary CT with conventional coronary angiography in all patients and providing sufficient data for a patient level analysis. Results 120 studies (10 287 patients) were eligible. Studies varied greatly in their approaches to handling non-evaluable findings. We found 26 studies (including 2298 patients) that allowed us to calculate both 2×2 tables and 3×2 tables. Using a bivariate random effects model, we compared the 2×2 table with the 3×2 table, and found significant differences for pooled sensitivity (98.2 (95% confidence interval 96.7 to 99.1) v 92.7 (88.5 to 95.3)), area under the curve (0.99 (0.98 to 1.00) v 0.93 (0.91 to 0.95)), positive likelihood ratio (9.1 (6.2 to 13.3) v 4.4 (3.3 to 6.0)), and negative likelihood ratio (0.02 (0.01 to 0.04) v 0.09 (0.06 to 0.15); (P<0.05)). Conclusion Parameters for diagnostic performance significantly decrease if non-evaluable results are included by a 3×2 table for analysis (intention to diagnose approach). This approach provides a more realistic picture of the clinical potential of diagnostic tests. PMID:23097549

  13. Osteocel Plus cellular allograft in anterior cervical discectomy and fusion: evaluation of clinical and radiographic outcomes from a prospective multicenter study.

    PubMed

    Eastlack, Robert K; Garfin, Steven R; Brown, Christopher R; Meyer, S Craig

    2014-10-15

    Prospective, multicenter, nonrandomized, institutional review board-approved clinical and radiographic study. To evaluate and summarize the 2-year outcomes of patients treated with Osteocel Plus cellular allograft as part of an anterior cervical discectomy and fusion procedure. Osteocel Plus is an allograft cellular bone matrix containing native mesenchymal stem cells and osteoprogenitor cells that is intended to mimic the performance of iliac crest autograft without the morbidity associated with its harvest. A total of 182 patients were treated with anterior cervical discectomy and fusion using Osteocel Plus in a polyetheretherketone cage and anterior plating at 1 or 2 consecutive levels. Clinical outcomes included visual analogue scale for neck and arm pain, neck disability index, and SF-12 physical and mental component scores. Computed tomography and plain film radiographic measures included assessment of bridging bone, disc height, disc angle, and segmental range of motion. A total of 249 levels were treated in 182 patients. Mean procedure time was 100 minutes, blood loss was less than 50 mL in 93% of patients, and hospital stay was 1 day or less in 84% of patients. Significant (P<0.05) average improvements in clinical outcomes from preoperatively to 24 months included the following: neck disability index: 21.5%; visual analogue scale neck: 34 mm; visual analogue scale arm: 35 mm; SF-12 physical component score: 11.2; SF-12 mental component score: 6.8. At 24 months, 93% of patients were satisfied with their outcome. In patients treated at a single level with a minimum of 24-month follow-up, 92% (79/86) of levels achieved solid bridging and 95% of levels demonstrated range of motion of less than 3°. In combined single- and 2-level procedures, 87% (157/180) of levels achieved solid bridging and 92% (148/161) had range of motion of less than 3° at 24 months. No patient required revision for pseudarthrosis. Improvements in clinical results at 2 years, high

  14. Evaluation of the illumigene C. difficile assay for toxigenic Clostridium difficile detection: a prospective study of 302 consecutive clinical fecal samples.

    PubMed

    Hong, Geehay; Park, Kyung Sun; Ki, Chang-Seok; Lee, Nam Yong

    2014-11-01

    Toxigenic Clostridium difficile is a major pathogen causing nosocomial diarrhea. Consequently, rapid detection of toxigenic C. difficile is very important in clinical laboratories. The illumigene C. difficile DNA amplification assay (illumigene; Meridian Bioscience, Inc.) is a rapid method that detects the toxin A gene (tcdA) by loop-mediated isothermal amplification. In the present study, we evaluated the diagnostic performance of the illumigene assay using 302 consecutive stool specimens in comparison with the VIDAS C. difficile A&B enzyme-linked fluorescent immunoassay (VIDAS-CDAB; bioMérieux). Toxigenic culture was used as the reference method. The sensitivity, specificity, positive predictive value, and negative predictive value of the illumigene assay were 88.1%, 96.7%, 86.7%, and 97.1%, respectively, while those of the VIDAS-CDAB assay were 40.4%, 98.8%, 87.5%, and 88.5%, respectively. It is of note that use of a combination of the illumigene and VIDAS-CDAB assays did not improve any of the 4 evaluated parameters (88.1%, 95.5%, 82.5%, and 97.1%, respectively). The illumigene assay showed limits of detection of 250 and 11,467 CFU/mL for ATCC 9688 (tcdA+, tcdB+, cdtB-) and ATCC 43598 (tcdA-, tcdB+, cdtB-) reference strains, respectively, and there was no cross-reactivity with 8 frequently isolated bacterial species. In conclusion, the illumigene assay might be a useful method for rapid detection of toxigenic C. difficile in clinical laboratories. Additionally, the VIDAS-CDAB assay seems unnecessary if the illumigene assay is used.

  15. A Sense of Urgency: Evaluating the Link between Clinical Trial Development Time and the Accrual Performance of CTEP-Sponsored Studies

    PubMed Central

    Cheng, Steven K.; Dietrich, Mary S.; Finnigan, Shanda; Dilts, David M.

    2010-01-01

    Purpose Post-activation barriers to oncology clinical trial accruals are well documented; however, potential barriers prior to trial opening are not. We investigate one such barrier: trial development time. Experimental Design National Cancer Institute Cancer Therapy Evaluation Program (CTEP)-sponsored trials for all therapeutic, non-pediatric Phase I, I/II, II, and III studies activated between 2000–2004 were investigated for an eight-year period (n=419). Successful trials were those achieving 100% of minimum accrual goal. Time to open a study was the calendar time from initial CTEP submission to trial activation. Multivariate logistic regression analysis was used to calculate unadjusted and adjusted odds ratios, controlling for study phase and size of expected accruals. Results 37.9 percent (n=221) of CTEP-approved oncology trials failed to attain the minimum accrual goals, with 70.8 percent (n=14) of Phase III trials resulting in poor accrual. A total of 16474 patients (42.5% of accruals) accrued to those studies that were unable to achieve the projected minimum accrual goal. Trials requiring less than 12 months development were significantly more likely to achieve accrual goals (odds ratio, 2.15; 95% CI, 1.29–3.57, P=0.003) than trials with the median development time of 12–18 months. Trials requiring a development time of greater than 24 months were significantly less likely of achieving accrual goals (odds ratio, 0.40; 95% CI, 0.20–0.78, P=0.011) than trials with the median development time. Conclusions A large percentage of oncology clinical trials do not achieve minimum projected accruals. Trial development time appears to be one important predictor of the likelihood of successfully achieving the minimum accrual goals. PMID:21062929

  16. Study protocol for a prospective, non-controlled, multicentre clinical study to evaluate the diagnostic accuracy of a stepwise two-photon excited melanin fluorescence in pigmented lesions suspicious for melanoma (FLIMMA study)

    PubMed Central

    Fink, Christine; Hofmann, Maja; Jagoda, Agata; Spaenkuch, Iris; Forschner, Andrea; Tampouri, Ioanna; Lomberg, Diana; Leupold, Dieter; Garbe, Claus; Haenssle, Holger A

    2016-01-01

    Introduction Non-invasive, nanosecond, stepwise two-photon laser excitation of skin tissue was shown to induce melanin fluorescence spectra that allow for the differentiation of melanocytic nevi from cutaneous melanoma. Methods and analysis This prospective, non-controlled, multicentre clinical study is performed to evaluate the diagnostic performance of the stepwise two-photon excited melanin fluorescence in the detection of cutaneous melanoma. The comparator will be the histopathological diagnosis. A total of 620 pigmented skin lesions suspicious for melanoma and intended for excision will be enrolled. Ethics and dissemination Ethics approval was provided by the local ethics committees of the medical faculties of the University of Tuebingen, Heidelberg and Berlin. Study registration The FLIMMA study NCT02425475. PMID:27993903

  17. Prospective study of the primary evaluation of 1016 horses with clinical signs of abdominal pain by veterinary practitioners, and the differentiation of critical and non-critical cases.

    PubMed

    Curtis, Laila; Burford, John Harold; Thomas, Jennifer Sara Marian; Curran, Marise Linda; Bayes, Tom Curtis; England, Gary Crane William; Freeman, Sarah Louise

    2015-10-06

    The majority of research on the evaluation of horses with colic is focused on referral hospital populations. Early identification of critical cases is important to optimise outcome and welfare. The aim of this prospective study was to survey the primary evaluation of horses with clinical signs of abdominal pain by veterinary practitioners, and compare the initial presentation of critical and non-critical cases. Data from 1016 primary evaluations of horses presenting with clinical signs of colic were submitted by 167 veterinary practitioners across the United Kingdom over a 13 month period. The mean age of the study population was 13.5 years (median 12.0, range 0-42). Mean heart rate on primary presentation was 47 beats/min (median 44, range 18-125), mean respiratory rate was 20 breaths/min (median 16, range 6-100), and median gastrointestinal auscultation score (0-12, minimum-maximum) was 5 (range 0-12). Clinical signs assessed using a behavioural severity score (0-17, minimum-maximum), were between 0 and 6 in 70.4 % of cases, and 7-12 for 29.6 % of cases. Rectal examination was performed in 73.8 % of cases. Cases that responded positively to simple medical treatment were categorised retrospectively as 'non-critical'; cases that required intensive medical treatment, surgical intervention, died or were euthanased were categorised as 'critical'. Eight-hundred-and-twenty-two cases met these criteria; 76.4 % were 'non-critical' and 23.6 % were 'critical'. Multivariable logistic regression was used to identify features of the clinical presentation associated with critical cases. Five variables were retained in the final multivariable model: combined pain score: (OR 1.19, P < 0.001, 95 % CI 1.09-1.30), heart rate (OR 1.06, P < 0.001, 95 % CI 1.04-1.08), capillary refill time >2.5 s (OR 3.21, P = 0.046, 95 % CI 1.023-10.09), weak pulse character (OR 2.90, P = 0.004, 95 % CI 1.39-5.99) and absence of gut sounds in ≥1 quadrant (OR 3.65, P < 0.001, 95

  18. [Evaluation of clinical usefulness of MR urography].

    PubMed

    Hasegawa, N; Miki, K; Kato, N; Ohishi, Y

    1999-08-01

    MR urography (MRU) is an image diagnostic method which provides us with the image of urinary retention under non-invasive procedures. This time, MRU was conducted in the patients who were suspected to have urinary passage disorder, and its clinical usefulness was compared with that of drip infusion pyelography (DIP) or retrograde pyelography (RP). The study was conducted in 65 patients who were suspected to have obstructive uropathy based on the ultrasonographic findings. MRU was conducted by means of fast SE method to obtain heavy T2-weighted image. The urogram was reconstructed by means of MIP (maximum intensity projection) method. As imaging examinations, MRU, DIP and RP were conducted respectively in 65, 47 and 27 patients. Evaluation of clinical usefulness of MRU and its indications were conducted with respect to (1) the degree of urinary retention which is identifiable by MRU by (2) comparing performance of MRU and that of other image diagnostic methods based on the scores given to MRU and other methods according to the following scale: Urinary tract is not identifiable 0 point Urinary tract is slightly identifiable 1 point The obstructive region is almost clearly identifiable 2 points The lesion causative for obstruction is identifiable 3 points. 1) Mild urinary retention for which overall image of urinary tract was barely identifiable by DIP was identifiable by MRU. 2) In the comparison between DIP and MRU, 24 patients whose urinary tracts were totally unidentifiable by DIP was given was 2.4 points in the average for the identifiability of urinary retention by MRU. Conversely, only poor images were attainable by MRU in the patients whose urinary flow was clearly seen in DIP. The patients whose urinary flow was clearly seen in RP was give 1.9 points in the average for the identifiability of urinary retention by MRU, indicating that relatively poor images were attainable by MRU in those patients. Mild urinary retention for which overall image of urinary tract

  19. Two-Dimensional Cutting (TDC) Vitrectome: In Vitro Flow Assessment and Prospective Clinical Study Evaluating Core Vitrectomy Efficiency versus Standard Vitrectome.

    PubMed

    Pavlidis, Mitrofanis

    2016-01-01

    Purpose. To evaluate comparative aspiration flow performance and also vitrectomy operating time efficiency using a double-cutting open port vitreous cutting system incorporated in a two-dimensional cutting (TDC, DORC International) vitrectome design versus standard vitreous cutter. Methods. In vitro investigations compared aspiration flow rates in artificial vitreous humor at varying cutter speeds and vacuum levels using a TDC vitrectome and a standard vitrectome across different aspiration pump systems. A prospective single-centre clinical study evaluated duration of core vitrectomy in 80 patients with macular pucker undergoing 25-gauge or 27-gauge vitrectomy using either a TDC vitrectome at 16,000 cuts per minute (cpm) or standard single-cut vitrectome, combined with a Valve Timing intelligence (VTi) pump system (EVA, DORC International). Results. Aspiration flow rates remained constant independent of TDC vitrectome cut rate, while flow rates decreased linearly at higher cutter speeds using a classic single-blade vitrectome. Mean duration of core vitrectomy surgeries using a TDC vitreous cutter system was significantly (p < 0.001) shorter than the mean duration of core vitrectomy procedures using a single-cut vitrectome of the same diameter (reduction range, 34%-50%). Conclusion. Vitrectomy surgery performed using a TDC vitrectome was faster than core vitrectomy utilizing a standard single-action vitrectome at similar cut speeds.

  20. Two-Dimensional Cutting (TDC) Vitrectome: In Vitro Flow Assessment and Prospective Clinical Study Evaluating Core Vitrectomy Efficiency versus Standard Vitrectome

    PubMed Central

    2016-01-01

    Purpose. To evaluate comparative aspiration flow performance and also vitrectomy operating time efficiency using a double-cutting open port vitreous cutting system incorporated in a two-dimensional cutting (TDC, DORC International) vitrectome design versus standard vitreous cutter. Methods. In vitro investigations compared aspiration flow rates in artificial vitreous humor at varying cutter speeds and vacuum levels using a TDC vitrectome and a standard vitrectome across different aspiration pump systems. A prospective single-centre clinical study evaluated duration of core vitrectomy in 80 patients with macular pucker undergoing 25-gauge or 27-gauge vitrectomy using either a TDC vitrectome at 16,000 cuts per minute (cpm) or standard single-cut vitrectome, combined with a Valve Timing intelligence (VTi) pump system (EVA, DORC International). Results. Aspiration flow rates remained constant independent of TDC vitrectome cut rate, while flow rates decreased linearly at higher cutter speeds using a classic single-blade vitrectome. Mean duration of core vitrectomy surgeries using a TDC vitreous cutter system was significantly (p < 0.001) shorter than the mean duration of core vitrectomy procedures using a single-cut vitrectome of the same diameter (reduction range, 34%–50%). Conclusion. Vitrectomy surgery performed using a TDC vitrectome was faster than core vitrectomy utilizing a standard single-action vitrectome at similar cut speeds. PMID:27190635

  1. An experimental study and a randomized, double-blind, placebo-controlled clinical trial to evaluate the antisecretory activity of Lactobacillus acidophilus strain LB against nonrotavirus diarrhea.

    PubMed

    Liévin-Le Moal, Vanessa; Sarrazin-Davila, Luis E; Servin, Alain L

    2007-10-01

    Previous studies have shown that selected strains of Lactobacillus have the capacity to antagonize rotavirus-induced diarrhea. However, only a few reports have documented their efficacy against nonrotavirus diarrhea. This study involved an experimental investigation and a clinical trial of the antisecretory activity of Lactobacillus acidophilus strain LB in the context of nonrotavirus diarrhea. The activity of a culture of L. acidophilus LB or of the lyophilized, heat-killed L. acidophilus LB bacteria plus their spent culture medium was tested in inhibiting the formation of fluid-formed domes in cultured human intestinal Caco-2/TC7 cell monolayers infected with diarrheagenic, diffusely adhering Afa/Dr Escherichia coli C1845 bacteria. A randomized, double-blind, placebo-controlled clinical trial of male or female children who were 10 months of age and presented with nonrotavirus, well-established diarrhea was conducted to evaluate the therapeutic efficacy of a pharmaceutical preparation that contains 10 billion heat-killed L. acidophilus LB plus 160 mg of spent culture medium. Infection of the cells with C1845 bacteria that were treated with L. acidophilus LB culture or the lyophilized, heat-killed L. acidophilus LB bacteria plus their culture medium produced a dosage-dependent decrease in the number of fluid-formed domes as compared with cells that were infected with untreated C1845 bacteria. The clinical results show that in selected and controlled homogeneous groups of children with well-established, nonrotavirus diarrhea, adding lyophilized, heat-killed L. acidophilus LB bacteria plus their culture medium to a solution of oral rehydration solution shortened by 1 day the recovery time (ie, the time until the first normal stool was passed) as compared with children who received placebo oral rehydration solution. Heat-killed L. acidophilus LB plus its culture medium antagonizes the C1845-induced increase in paracellular permeability in intestinal Caco-2/TC7 cells

  2. Evaluation of anti-microbial activity of spore powder of Ganoderma lucidum on clinical isolates of Prevotella intermedia: A pilot study

    PubMed Central

    Nayak, Ranganath N.; Dixitraj, P. T.; Nayak, Aarati; Bhat, Kishore

    2015-01-01

    Aim: This study aimed at evaluating the anti-microbial activity of spore powder of Ganoderma lucidum on Prevotella intermedia isolated from subgingival plaque from chronic periodontitis patients. Settings and Design: Written informed consent was obtained from each subject enrolled in the study. The Institutional Ethics Committee granted the ethical clearance for the study. Materials and Methods: This study included 20 patients diagnosed with chronic periodontitis. Pooled subgingival plaque samples were collected using sterile curettes from the deepest sites of periodontal pockets. The collected samples were then transported in 1 mL of reduced transport fluid. The organisms were cultured and confirmed. These organisms were then used for minimum inhibitory concentration (MIC) procedure. Statistical Analysis: Mean of the MIC value obtained was calculated. Results: Thirteen out of the 20 clinical samples were tested that showed sensitivity at various concentrations. Five samples showed sensitivity at all concentrations. Twelve samples showed sensitivity at 8 mcg/ml. Eleven samples showed sensitivity at 4 mcg/ml, 8 samples showed sensitivity at 2 mcg/ml, and 5 samples showed sensitivity even at 1 mcg/ml. Mean MIC value of G. lucidum spore powder for P. intermedia obtained was 3.62 mcg/ml. Conclusion: G. lucidum with its multipotential bioactivity could be used as an anti-microbial, in conjunction with conventional therapy in periodontal disease. PMID:26604581

  3. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol.

    PubMed

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T; Calvert, Melanie

    2016-09-21

    Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer-reviewed journals and social media including the CPROR twitter account

  4. Systematic evaluation of patient-reported outcome (PRO) protocol content and reporting in UK cancer clinical trials: the EPiC study protocol

    PubMed Central

    Ahmed, Khaled; Kyte, Derek; Keeley, Thomas; Efficace, Fabio; Armes, Jo; Brown, Julia M; Calman, Lynn; Copland, Chris; Gavin, Anna; Glaser, Adam; Greenfield, Diana M; Lanceley, Anne; Taylor, Rachel; Velikova, Galina; Brundage, Michael; Mercieca-Bebber, Rebecca; King, Madeleine T

    2016-01-01

    Introduction Emerging evidence suggests that patient-reported outcome (PRO)-specific information may be omitted in trial protocols and that PRO results are poorly reported, limiting the use of PRO data to inform cancer care. This study aims to evaluate the standards of PRO-specific content in UK cancer trial protocols and their arising publications and to highlight examples of best-practice PRO protocol content and reporting where they occur. The objective of this study is to determine if these early findings are generalisable to UK cancer trials, and if so, how best we can bring about future improvements in clinical trials methodology to enhance the way PROs are assessed, managed and reported. Hypothesis: Trials in which the primary end point is based on a PRO will have more complete PRO protocol and publication components than trials in which PROs are secondary end points. Methods and analysis Completed National Institute for Health Research (NIHR) Portfolio Cancer clinical trials (all cancer specialities/age-groups) will be included if they contain a primary/secondary PRO end point. The NIHR portfolio includes cancer trials, supported by a range of funders, adjudged as high-quality clinical research studies. The sample will be drawn from studies completed between 31 December 2000 and 1 March 2014 (n=1141) to allow sufficient time for completion of the final trial report and publication. Two reviewers will then review the protocols and arising publications of included trials to: (1) determine the completeness of their PRO-specific protocol content; (2) determine the proportion and completeness of PRO reporting in UK Cancer trials and (3) model factors associated with PRO protocol and reporting completeness and with PRO reporting proportion. Ethics and dissemination The study was approved by the ethics committee at University of Birmingham (ERN_15-0311). Trial findings will be disseminated via presentations at local, national and international conferences, peer

  5. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol

    PubMed Central

    2013-01-01

    Background Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing. The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children’s obesity. Methods/Design The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the

  6. Evaluation of a family intervention programme for the treatment of overweight and obese children (Nereu Programme): a randomized clinical trial study protocol.

    PubMed

    Serra-Paya, Noemi; Ensenyat, Assumpta; Real, Jordi; Castro-Viñuales, Iván; Zapata, Amalia; Galindo, Gisela; Solé-Mir, Eduard; Bosch-Muñoz, Jordi; Mur, Jose Maria; Teixidó, Concepció

    2013-10-23

    Obesity is mainly attributed to environmental factors. In developed countries, the time spent on physical activity tasks is decreasing, whereas sedentary behaviour patterns are increasing.The purpose of the intervention is to evaluate the effectiveness of an intensive family-based behavioural multi-component intervention (Nereu programme) and compared it to counselling intervention such as a health centre intervention programme for the management of children's obesity. The study design is a randomized controlled multicenter clinical trial using two types of interventions: Nereu and Counselling. The Nereu programme is an 8-month intensive family-based multi-component behavioural intervention. This programme is based on a multidisciplinary intervention consisting of 4 components: physical activity sessions for children, family theoretical and practical sessions for parents, behaviour strategy sessions involving both, parents and children, and lastly, weekend extra activities for all. Counselling is offered to the family in the form of a monthly physical health and eating habits session. Participants will be recruited according the following criteria: 6 to 12 year-old-children, referred from their paediatricians due to overweight or obesity according the International Obesity Task Force criteria and with a sedentary profile (less than 2 hours per week of physical activity), they must live in or near the municipality of Lleida (Spain) and their healthcare paediatric unit must have previously accepted to cooperate with this study. The following variables will be evaluated: a) cardiovascular risk factors (anthropometric parameters, blood test and blood pressure), b) sedentary and physical activity behaviour and dietary intake, c) psychological aspects d) health related quality of life (HRQOL), e) cost-effectiveness of the intervention in relation to HRQOL. These variables will be then be evaluated 4 times longitudinally: at baseline, at the end of the intervention (8

  7. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study.

    PubMed

    Williams, Bryan; Lacy, Peter S; Thom, Simon M; Cruickshank, Kennedy; Stanton, Alice; Collier, David; Hughes, Alun D; Thurston, H; O'Rourke, Michael

    2006-03-07

    Different blood pressure (BP)-lowering drugs could have different effects on central aortic pressures and thus cardiovascular outcome despite similar effects on brachial BP. The Conduit Artery Function Evaluation (CAFE) study, a substudy of the Anglo-Scandinavian Cardiac Outcomes Trial (ASCOT), examined the impact of 2 different BP lowering-regimens (atenolol+/-thiazide-based versus amlodipine+/-perindopril-based therapy) on derived central aortic pressures and hemodynamics. The CAFE study recruited 2199 patients in 5 ASCOT centers. Radial artery applanation tonometry and pulse wave analysis were used to derive central aortic pressures and hemodynamic indexes on repeated visits for up to 4 years. Most patients received combination therapy throughout the study. Despite similar brachial systolic BPs between treatment groups (Delta0.7 mm Hg; 95% CI, -0.4 to 1.7; P=0.2), there were substantial reductions in central aortic pressures with the amlodipine regimen (central aortic systolic BP, Delta4.3 mm Hg; 95% CI, 3.3 to 5.4; P<0.0001; central aortic pulse pressure, Delta3.0 mm Hg; 95% CI, 2.1 to 3.9; P<0.0001). Cox proportional-hazards modeling showed that central pulse pressure was significantly associated with a post hoc-defined composite outcome of total cardiovascular events/procedures and development of renal impairment in the CAFE cohort (unadjusted, P<0.0001; adjusted for baseline variables, P<0.05). BP-lowering drugs can have substantially different effects on central aortic pressures and hemodynamics despite a similar impact on brachial BP. Moreover, central aortic pulse pressure may be a determinant of clinical outcomes, and differences in central aortic pressures may be a potential mechanism to explain the different clinical outcomes between the 2 BP treatment arms in ASCOT.

  8. Placebo-controlled, double-blind, randomized, prospective study of a glycerol-based emollient on eczematous skin in atopic dermatitis: biophysical and clinical evaluation.

    PubMed

    Breternitz, M; Kowatzki, D; Langenauer, M; Elsner, P; Fluhr, J W

    2008-01-01

    Atopic dermatitis (AD) is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of AD are dry skin, intense pruritus and impaired epidermal barrier function. The therapeutic management of AD is difficult and needs individualized concepts. Moisturizing creams and emollients are useful and important treatment adjuncts for the daily skin care of patients with dry and inflamed skin, e.g. AD. Glycerol is known to increase stratum corneum (SC) hydration, improve epidermal barrier function and decrease clinical signs of inflammation. However, no controlled study on the efficacy of glycerol on barrier function and SC hydration in AD has been published. In the present study, a topical 20% glycerol preparation was compared with its vehicle in patients with AD. The aim of the present study was to evaluate the effect of a single emollient ingredient in AD within the full frame of a phase III drug study. 24 patients with AD were treated for 4 weeks twice daily with a glycerol-based emollient in a randomized, double-blind study. Transepidermal water loss, skin capacitance, erythema and skin surface pH were assessed with biophysical, non-invasive instruments. The SCORAD and a local severity score were evaluated. After a wash-out period of 2 weeks, these parameters were assessed in order to quantify the sustained effect of this treatment. SC hydration was significantly improved, and epidermal barrier function was restored under treatment with glycerol-containing cream compared to the glycerol-free placebo. No significant differences were detectable for erythema values, SCORAD and local severity between the glycerol-containing cream and placebo. However, an improvement over time was detectable in the assessed parameters in both groups indicating the importance of emollient treatment in AD. Glycerol-based emollients have a positive influence on the skin of patients with AD. They enhance the SC hydration

  9. Learn about Clinical Studies

    MedlinePlus

    ... already available to each other. When a new product or approach is being studied, it is not usually known ... the development and marketing of new drugs, biological products, and medical devices. Sometimes, the safety and the effectiveness of the experimental approach or use may not be fully known at ...

  10. ACCP: economic evaluations of clinical pharmacy services: 2001-2005.

    PubMed

    Perez, Alexandra; Doloresco, Fred; Hoffman, James M; Meek, Patrick D; Touchette, Daniel R; Vermeulen, Lee C; Schumock, Glen T

    2009-01-01

    The objectives of this review were to summarize and evaluate studies that measured the economic impact of clinical pharmacy services published between 2001 and 2005 (inclusive) and to provide guidance on methodologic considerations to individuals performing such research in the future. A systematic literature search using the MEDLINE and International Pharmaceutical Abstracts databases was conducted to identify published economic evaluations of clinical pharmacy services. Studies were screened and then randomly assigned to reviewers, who reassessed inclusion and exclusion criteria and abstracted prespecified data from each study. Among the many characteristics examined in each study were study design and type of economic evaluation, setting and type of clinical pharmacy service, study quality, and results. Ninety-three articles were included in the final analysis. These studies were published in 43 different journals, most of which (68 [73.1%]) were pharmacy-based. Most studies were performed in hospitals (40 [43.0%]), ambulatory care clinics or physician's offices (20 [21.5%]), or community pharmacies (16 [17.2%]). The most common types of clinical pharmacy services evaluated were general pharmacotherapeutic monitoring services (32 [34.4%]), target drug programs (27 [29%]), and disease state-management services (21 [22.6%]). Full economic evaluations were performed in just less than half (45 [48.4%]) of the studies, and a positive economic benefit associated with clinical pharmacy services was noted in 31 (69%) of the 45 studies. Among 15 studies reporting data necessary to determine a benefit:cost ratio, the pooled median value was 4.81:1-meaning that for every $1 invested in clinical pharmacy services, $4.81 was achieved in reduced costs or other economic benefits. The quality of studies varied widely, with less than one half considered to be good to fair (40 [43.0%]); however, the proportion of studies using appropriate study designs increased compared with

  11. Evaluation of the reliability and validity of the Medical Outcomes Study sleep scale in patients with painful diabetic peripheral neuropathy during an international clinical trial

    PubMed Central

    Viala-Danten, Muriel; Martin, Susan; Guillemin, Isabelle; Hays, Ron D

    2008-01-01

    Background Sleep is an important element of functioning and well-being. The Medical Outcomes Study Sleep Scale (MOS-Sleep) includes 12 items assessing sleep disturbance, sleep adequacy, somnolence, quantity of sleep, snoring, and awakening short of breath or with a headache. A sleep problems index, grouping items from each of the former domains, is also available. This study evaluates the psychometric properties of MOS-Sleep Scale in a painful diabetic peripheral neuropathic population based on a clinical trial conducted in six countries. Methods Clinical data and health-related quality of life data were collected at baseline and after 12 weeks of follow-up. Overall, 396 patients were included in the analysis. Psychometric properties of the MOS-Sleep were assessed in the overall population and per country when the sample size was sufficient. Internal consistency reliability was assessed by Cronbach's alpha; the structure of the instrument was assessed by verifying item convergent and discriminant criteria; construct validity was evaluated by examining the relationships between MOS-Sleep scores and sleep interference and pain scores, and SF-36 scores; effect-sizes were used to assess the MOS-Sleep responsiveness. The study was conducted in compliance with United States Food and Drug Administration regulations for informed consent and protection of patient rights. Results Cronbach's alpha ranged from 0.71 to 0.81 for the multi-item dimensions and the sleep problems index. Item convergent and discriminant criteria were satisfied with item-scale correlations for hypothesized dimensions higher than 0.40 and tending to exceed the correlations of items with other dimensions, respectively. Taken individually, German, Polish and English language versions had good internal consistency reliability and dimension structure. Construct validity was supported with lower sleep adequacy score and greater sleep problems index scores associated with measures of sleep interference and

  12. A study of radiological scoring system evaluating extrapancreatic inflammation with conventional radiological and clinical scores in predicting outcomes in acute pancreatitis.

    PubMed

    Sharma, Vishal; Rana, Surinder S; Sharma, Ravi K; Kang, Mandeep; Gupta, Rajesh; Bhasin, Deepak K

    2015-01-01

    A number of scoring systems are available to predict prognosis in acute pancreatitis (AP). The aim of the study was to compare extra-pancreatic inflammation on computed tomography (CT) (EPIC score) and renal rim sign with clinical scores (BISAP, SIRS) and conventional CT severity index (CTSI) and modified CTSI (MCTSI) in predicting persistent organ failure (POF), intervention and mortality. The demographic, clinical and radiographic data from patients with AP were retrospectively evaluated. The scores were evaluated by calculating receiver operator characteristic (ROC) curves and area under the ROC (AUROC). Of the 105 patients (65 males; mean age 40.6±12.9 years) included, 8 died, 71 developed POF, and 16 needed intervention. The mean CTSI, MCTSI and EPIC scores were 5.8±3.0, 7.1±2.6 and 4.0±1.9 respectively. The AUROC for SIRS, BISAP, CTSI, MCTSI, Renal Rim Score and EPIC score in predicting POF were 0.65 (95%CI 0.53-0.78), 0.75 (95%CI 0.65-0.86), 0.66 (95%CI 0.54-0.78), 0.70 (95%CI 0.58-0.81), 0.64 (95%CI 0.52-0.76), 0.71 (95%CI 0.60-0.83), for radiological/endoscopic intervention were 0.50 (95%CI 0.35-0.65), 0.64 (95%CI 0.49-0.78), 0.51 (95%CI 0.36-0.66), 0.55 (95%CI 0.41-0.70), 0.51 (95%CI 0.36-0.67), 0.66 (95%CI 0.52-0.81), and for mortality 0.57 (95%CI 0.38-0.75), 0.90 (95%CI 0.83-0.97), 0.67 (95%CI 0.50-0.83), 0.68 (95%CI 0.51-0.85), 0.73 (95%CI 0.57-0.89) and 0.77 (95%CI 0.64-0.90) respectively. The prognostic performance of various clinical and radiological scoring systems in AP is comparable with BISAP having the highest accuracy for predicting POF and mortality.

  13. Evaluation of a Rheumatology Transition Clinic.

    PubMed

    Stringer, Elizabeth; Scott, Rachel; Mosher, Dianne; MacNeill, Inez; Huber, Adam M; Ramsey, Suzanne; Lang, Bianca

    2015-06-11

    An adolescent with a chronic condition must prepare for transition from the pediatric to the adult health care system. Ideally, transition is a purposeful and coordinated process between the two systems. We sought to evaluate a pediatric rheumatology transition clinic from the perspective of the young adults who attended the clinic. Young adults who attended the IWK Health Centre Pediatric Rheumatology Transition Clinic in Halifax, Nova Scotia, Canada were asked to complete a mail questionnaire. In this clinic an adult rheumatologist joins the pediatric team for the patient's visit. Subjects rated satisfaction with the clinic and how completely a number of items were addressed (e.g. knowledge about disease, self-management, adolescent issues) on a 10 cm visual analog scale (higher scores reflecting more favourable assessment). Compliance with follow-up post-transfer to adult care was assessed by self-report and a chart review. Data were summarized descriptively. The response rate was 34% (51/151). The mean age of respondents was 22 years with the majority diagnosed with juvenile idiopathic arthritis. Most patients were transferred to adult care between the ages of 17 and 20 years. The mean overall satisfaction score with the transition clinic was 7.3 ± 2.6. There was significant variability regarding how well individual transition-related items were perceived to have been addressed, with an overall mean of 6.1 ± 3.2. Items which received a majority of scores of > 7 included learning about side effects of medications, learning to live with their disease, confidence in disease management, and control of disease at transfer. Items rated as <5 by a third of respondents included addressing teen issues (smoking, alcohol, sexual health) and learning about new developments related to their condition. 74% of patients reported regular appointments with adult rheumatology. Most young adults reported overall satisfaction with the transition clinic, however their

  14. Comparative evaluation of co-enzyme Q10 and Melaleuca alternifolia as antioxidant gels in treatment of chronic periodontitis: A clinical study

    PubMed Central

    Raut, Chetan Purushottam; Sethi, Kunal S.

    2016-01-01

    Background: Conventional nonsurgical periodontal therapy has been proven to be an effective treatment for patients with chronic periodontitis. Coenzyme Q10 and tea tree oil (TTO) are known to have potential therapeutic benefits in chronic periodontitis. Aims: The aim of the study is to compare the efficacy of Coenzyme Q10 (Perio Q®) and tea tree oil (Melaleuca alternifolia) gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis. Materials and Methods: Patients were divided equally into three groups: Group I (Control group): those receiving placebo gel + SRP, Group II (Test group I): those receiving Perio QTM gel + SRP, and Group III (Test group II): those receiving tea tree oil gel + SRP. A total of 15 patients with 45 sites were enrolled in the study. Clinical parameters evaluated were plaque index (PI), gingival bleeding index (GI), probing pocket depth (PPD), and clinical attachment level (CAL). Statistical Analysis Used: Paired t-test was applied using SPSS software. Results: Mean PPD reduction for Group I, Group II, and Group III was 0.50 ± 0.2, 2.95 ± 0.20, and 2.09 ± 0.15, respectively. Mean CAL reduction for Group I, Group II, and Group III was 0.45 ± 0.22, 2.33 ± 0.04, and 2.28 ± 0.09, respectively. Changes in mean PI scores for Group I, Group II, and Group III were 0.67 ± 017, 1.00 ± 0.11, and 1.08 ± 0.05 and GBI scores were 0.92 ± 0.29, 1.08 ± 0.13, and 0.88 ± 0.28, respectively. Conclusions: Coenzyme Q10 and tea tree oil gel proved to be effective in the treatment of chronic periodontitis. PMID:27630504

  15. A phase 1 randomized open-label clinical study to evaluate the safety and tolerability of a novel recombinant hepatitis E vaccine.

    PubMed

    Cao, Yu-Feng; Tao, Hong; Hu, Yue-Mei; Shi, Cheng-Bo; Wu, Xing; Liang, Qi; Chi, Chun-Ping; Li, Li; Liang, Zheng-Lun; Meng, Ji-Hong; Zhu, Feng-Cai; Liu, Zhao-Hui; Wang, Xin-Ping

    2017-09-05

    This study aimed to evaluate the safety and tolerability for variable dosages of a novel hepatitis E vaccine p179. The randomized open-label parallel control phase 1 clinical trial enrolled 120 eligible participants aged 16-65years in Jiangsu Province, China. The experimental groups were randomized to receive different dosages of 20μg, 30μg, and 40μg Hepatitis E Virus (HEV) p179 vaccines, with the 30μgHEV vaccine p239 Hecolin as control, and vaccinated at 0, 1 and 6month intervals. Participants were observed for solicited local and systemic adverse reactions (ARs) occurring within 7days after each vaccination, and any serious adverse events (SAEs) occurring within 6months post-vaccination. Blood samples were collected from participants 3days before and after each injection, to determine the blood routine and serum biochemical indexes. The solicited local ARs incidence in experimental groups were significantly lower than that of the control group (P=0.027). The difference between solicited total and systemic ARs incidence of experimental groups and the control group were not significant (P>0.05). Similar patterns were observed when the analyses were performed on the group having ARs of varying grades and symptoms. All changes in blood biochemical indexes and routine blood tests before and after different vaccinations were mild (grade 1) or moderate (grade 2), and the difference in experimental groups and the control group were not statistically significant. No vaccine related SAEs occurred in any of the subjects during the study. Three different dosages of HEV p179 vaccine were deemed safe and well tolerated. No vaccine-associated SAEs were identified, and the 30μg dosage formulation was selected for further investigation for efficacy. Clinical trials registration number: 2012L01657. Copyright © 2017 Elsevier Ltd. All rights reserved.

  16. Safety aspects of Chinese herbal medicine in pregnancy-re-evaluation of experimental data of two animal studies and the clinical experience.

    PubMed

    Wiebrecht, Axel; Gaus, Wilhelm; Becker, Simon; Hummelsberger, Josef; Kuhlmann, Kirsten

    2014-10-01

    Chinese herbal medicine is an increasingly popular worldwide medical therapy which also has an impact in pregnancy. However, the question of its drug safety during pregnancy remains unresolved. Potential problems include teratogenicity, abortion, perinatal toxicity, pre- and postnatal developmental abnormalities, and eventually an increased risk for carcinomas in the offspring. Standard Materia Medica textbooks contain unreliable information when it comes to risks during pregnancy. Wang and co-workers conducted an experimental study (WS) on mice in which they investigated the effects of 17 Chinese medicinals regarding embryotoxicity and fetotoxicity. All these drugs seemed to exhibit multiple significant toxic effects. Another study by Li and co-workers (LS) investigated the reproductive toxicity of Atractylodis macrocephalae Rhizoma in mice, rats and rabbits. They described an increased pre- and postnatal mortality and, at high doses, congenital malformations. In an attempt to identify the risks of the tested medicinals during pregnancy, we analysed these two experimental studies and compared their results with possible safety data for humans from two reviews of clinical studies on threatened miscarriage (AR and CR). We re-evaluated WS and LS in relation to accordance with internationally accepted rules, equivalence to human dose, biometric accuracy, plausibility, and coherence. Eligible studies of the two reviews on threatened miscarriage were evaluated for specific pregnancy risks concerning the 17 medicinals tested in WS and LS. We found that WS does not conform to international ICH guidelines and includes many inconsistencies, implausibilities and several severe biometrical flaws. It reported a total of 364 significant events out of which 145 false significant results are expected. The data-handling pointed to irregularities. Analysis of LS exhibited also many inconsistencies. The results regarding congenital malformations were statistically insignificant and

  17. [A clinical study of gingival tattooing].

    PubMed

    Gbane, M; Assoumou, M; Abouattier-Mansilla, E

    1998-06-01

    Tattooing gingiva is a current practice in traditional areas. Only women are concerned by it. Thus this study recommends to evaluate clinical characteristics of tattooed gingiva and their influence on the woman's beauty and elegance. This study revealed that: explored tattooed gingiva do not show any significant lesions, tattooing the gingiva remains a woman's beauty mark, its produce esthetic effects and a wellbeing.

  18. Home Start Evaluation Study.

    ERIC Educational Resources Information Center

    High/Scope Educational Research Foundation, Ypsilanti, MI.

    Case studies of eight Home Start programs are given as the third section of an evaluation study. Communities involved are Binghamton, New York; Franklin, North Carolina; Cleveland, Ohio; Harrogate, Tennessee; Houston, Texas; Weslaco, Texas; Millville, Utah; Parkersburg, West Virginia. Although each study varies in format, each describes in detail…

  19. Clinical laboratory studies of disinfection with Sporicidin.

    PubMed Central

    Isenberg, H D

    1985-01-01

    The clinical microbiology laboratory evaluation of disinfectants can serve as a guide for their application to reduce hospital-acquired infections. The use of Sporicidin, a glutaraldehyde-phenol formulation, was evaluated by the application of modified MIC and MBC determinations for standard organisms. In addition, the effect of this formulation on bacteria that may proliferate in water at ambient temperatures was studied. This investigation indicated that such studies can help the clinical microbiologist to guide the use of disinfectants and sterilants for the maintenance of a safe hospital environment. PMID:3932457

  20. Assessment of the antidandruff activity of a new shampoo: a randomized, double-blind, controlled study by clinical and instrumental evaluations.

    PubMed

    Sparavigna, Adele; Setaro, Michele; Caserini, Maurizio; Bulgheroni, Anna

    2013-01-01

    The aim of this randomized, double-blind, controlled study was to evaluate the antidandruff activity exerted by a new shampoo on patients affected by dandruff and/or mild seborrheic dermatitis by means of both D-squame technique coupled with image analysis and clinical assessments. Thirty-four patients were enrolled and 1:1 randomly assigned to either a test shampoo or a comparative shampoo group. Treatment schedule was twice a week for 4 weeks. The D-squame technique was shown to be able to objectively record variations in scalp desquamation both between test and comparative groups and within the same group over time. The results obtained with this instrumental approach showed a statistically significant reduction by 52% vs baseline after 2 weeks of treatment. There was an even greater reduction after 4 weeks (-66%). This reduction was statistically significant compared with the comparative group at the same time points. The analysis of all the other parameters (except Wood's lamp) confirmed the superiority of the test vs the comparative shampoo. The test shampoo proved to be safe, well tolerated, and accepted by the patients for cosmetic acceptability and efficacy. The study confirmed the antidandruff efficacy of the test shampoo and its superiority vs the comparative shampoo.

  1. Clinical Study on the Management of Huzaz/Abria (Dandruff) with a pharmacopoeal Preparation of a Unani Medicine and its Cosmetic Evaluation

    PubMed Central

    Shah, Altaf Hussain; Haji, Amanullah; Rather, Shameem Ahmad; Ahmad, Tanzeel; Ansari, Abdul Nasir; Soff, G

    2009-01-01

    Dandruff called Huzaz/Abria in Unani medicine is a common ailment in the world with easy options of treatment. Most of the treatment options have ignored the cosmetic aspect of hair. Unani medicine has got a vast array of drug formulation to evaluate the efficacy of Unani pharmacopoeal formulation in mild form of seborrhic dermatitis of scalp (dandruff). Its efficacy was compared with standard drug (2% ketakonazole shampoo). Patients were enrolled after ethical clearance and informed consent in the study. 30 patients were treated with Unani formulation and 20 patients with the standard drug. The assessment of various parameters like Itching, Scalp shedding, Erythema, Hair frizz, Hair combing ease, and Hair smoothness was made before and after 30 days. The assessments of the parameters were analyzed and compared using appropriate statistical tests. The study revealed that Unani formulation was equally effective as standard drug and the hair comesis was better than the standard drug as seen clinically, but was not statistically significant (p=0.576). PMID:22557347

  2. A prospective clinical study to evaluate the safety and performance of wireless localization of nonpalpable breast lesions using radiofrequency identification technology.

    PubMed

    Dauphine, Christine; Reicher, Joshua J; Reicher, Murray A; Gondusky, Christina; Khalkhali, Iraj; Kim, Michelle

    2015-06-01

    The purpose of this study was to evaluate the safety and performance of localizing nonpalpable breast lesions using radiofrequency identification technology. Twenty consecutive women requiring preoperative localization of a breast lesion were recruited. Subjects underwent placement of both a hook wire and a radiofrequency identification tag immediately before surgery. The radiofrequency identification tag was the primary method used by the operating surgeon to localize each lesion during excision, with the hook wire serving as backup in case of tag migration or failed localization. Successful localization with removal of the intended lesion was the primary outcome measured. Tag migration and postoperative infection were also noted to assess safety. Twenty patients underwent placement of a radiofrequency identification tag, 12 under ultrasound guidance and eight with stereotactic guidance. In all cases, the radiofrequency identification tag was successfully localized by the reader at the level of the skin before incision, and the intended lesion was removed along with the radiofrequency identification tag. There were no localization failures and no postoperative infections. Tag migration did not occur before incision, but in three cases, occurred as the lesion was being retracted with fingers to make the final cut along the deep surface of the specimen. In this initial clinical study, radiofrequency tags were safe and able to successfully localize nonpalpable breast lesions. Radiofrequency identification technology may represent an alternative method to hook wire localization.

  3. Clinical study of ectopic pregnancy.

    PubMed

    Chhabra, S; Aher, K; Jaiswal, M

    1992-01-01

    Ectopic pregnancy remains a leading cause of maternal mortality and accounts for a sizeable proportion of infertility and ectopic recurrence. The possibility that a woman is experiencing an ectopic pregnancy must be considered when evaluating a woman, especially a sterilized woman, who has a possible pregnancy, amenorrhea, abdominal pain, or abnormal bleeding; studies have found that one in six pregnancies occurring after tubal sterilization are ectopic. The authors present a clinical study of 82 cases of ectopic pregnancy admitted to the department of Obstetrics and Gynecology of Mahatma Gandhi Institute of Medical Sciences, Sevagram. Cases of ectopic pregnancy represent 0.99% of total obstetric admissions, of whom 69.51% were diagnosed as such on admission. 40.24% of the women were older than 30 years, while 34.14% were elderly beyond third parity. 70.73% of the women presented before missing their second period. Patients presented with multiple complaints, but the most common was abdominal pain reported by 61.70%. 78.04% were admitted with an acute abdomen, but shock was present in only 7.14% of cases. The main surgical treatment modality was salpingectomy among 59.75%. There was no maternal mortality through postoperative morbidity in the form of paralytic ileus, although fever did occur in some women.

  4. Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

    PubMed

    Fortnum, Heather; Leighton, Paul; Smith, Murray D; Brown, Lisa; Jones, Matthew; Benton, Claire; Marder, Elizabeth; Marshall, Andrew; Sutton, Kate

    2014-09-01

    There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. UK (professionals); East Midlands region of the UK (parents). Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or

  5. Evaluation of performance of veterinary in-clinic hematology analyzers.

    PubMed

    Rishniw, Mark; Pion, Paul D

    2016-12-01

    A previous study provided information regarding the quality of in-clinic veterinary biochemistry testing. However, no similar studies for in-clinic veterinary hematology testing have been conducted. The objective of this study was to assess the quality of hematology testing in veterinary in-clinic laboratories using results obtained from testing 3 levels of canine EDTA blood samples. Clinicians prepared blood samples to achieve measurand concentrations within, below, and above their RIs and evaluated the samples in triplicate using their in-clinic analyzers. Quality was assessed by comparison of calculated total error with quality requirements, determination of sigma metrics, use of a quality goal index, and agreement between in-clinic and reference laboratory instruments. Suitability for statistical quality control was determined using adaptations from the computerized program, EZRules3. Evaluation of 10 veterinary in-clinic hematology analyzers showed that these instruments often fail to meet quality requirements. At least 60% of analyzers reasonably determined RBC, WBC, HCT, and HGB, when assessed by most quality goal criteria; platelets were less reliably measured, with 80% deemed suitable for low platelet counts, but only 30% for high platelet counts, and automated differential leukocyte counts were generally considered unsuitable for clinical use with fewer than 40% of analyzers meeting the least stringent quality goal requirements. Fewer than 50% of analyzers were able to meet requirements for statistical quality control for any measurand. These findings reflect the current status of in-clinic hematology analyzer performance and provide a basis for future evaluations of the quality of veterinary laboratory testing. © 2016 American Society for Veterinary Clinical Pathology.

  6. [Evaluation of temporo-mandibular myoarthropathies, the status of the masticatory system and patients' personality based on the tests and clinical studies].

    PubMed

    Czajkowska, E

    1992-01-01

    Resorting to commonly applied methods and clinical indices, the masticatory organ state was evaluated in 64 patients with symptoms of myoarthropathy (studied group)) and in 61 patients without the symptoms of the disease (control group). The assumption laid down in the work was that the studied group and the control one do differ with regard to the incidence rate and the intensity of the investigated local parameters and the level of neuroticism as well as extraversion. The aim of the paper was to show the mutual correlation between the parameters studied, and to determine their effect on the inception of the temporal jaw dysfunction. It has been revealed that the advancement of age is accompanied by statistically significant increase in the incidence rate and intensity of local diseases as well as by malfunctions, a rise in the level of neuroticism and a drop of the extraversion level. In consequence of the former findings, severe forms of dysfunction of the mandibular articulation arose in 89% of patients within the highest age group. Comparing the parameters between the studied group and the controls provided the possibility to isolate the features that make the both groups differ, thus facilitating the determination of the influence the individual factors exert on the origination of dysfunction of the mandibular articulation. The most essential differences affected five factors: unilateral mode of mastication, parafunction, teeth deficit, abnormal occlusion and high neuroticism. The lack of statistically significant differences between the studied and control groups with respect to periodontal diseases, looseness of teeth, dental abrasion do not authorize us to exclude their influence on the formation of temporal jaw myoarthropathy, since these factors are responsible for the l