Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

PubMed

Sices, Laura; Pawlowski, Katherine; Farfel, Laura; Phillips, Deirdre; Howe, Yamini; Cochran, David M; Choueiri, Roula; Forbes, Peter W; Brewster, Stephanie J; Frazier, Jean A; Neumeyer, Ann; Bridgemohan, Carolyn

2017-09-01

Recruitment and completion of research activities during regular clinical care has the potential to increase research participation in complex neurodevelopmental disorders. We evaluated the feasibility, and effect on clinical care, of conducting biomarker research within a subspecialty clinical visit for autism spectrum disorder (ASD). Children, aged 5 to 10 years, were recruited by providers in ASD clinics at 5 institutions. Biomarkers collected were growth measurements, head circumference, neurologic and dysmorphology examinations, digit ratio (2D:4D) measurement, and platelet serotonin and urinary melatonin sulfate excretion levels. Parents completed the Aberrant Behavior Checklist-Community and a medical/demographic questionnaire. Cognitive level was abstracted from the medical record. Parents and clinicians completed surveys on the effect of the study on the clinical visit. Eighty-three children and their caregivers participated. Factors limiting participation included difficulty reaching families by phone and parent concern about the study blood draw requirement. All children completed at least 4 of 7 planned research activities. Demographic factors, educational placement, and child behavior were not associated with completion of study activities. Lower nonverbal cognitive function was weakly associated with fewer activities completed. Forty-four percent of clinicians reported an effect of the research study on the clinical visit. However, neither parent-reported nor clinician-reported effect was associated with the degree of study activity completion. Recruiting study participants in the context of scheduled ASD clinical visits required significant effort. However, once recruited, participants completed most study activities, regardless of behavioral symptom severity. Research activities did not adversely affect the clinical visit.

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.

The impact of complete denture making instructional videos on self-directed learning of clinical skills.

PubMed

Kon, Haruka; Botelho, Michael George; Bridges, Susan; Leung, Katherine Chiu Man

2015-04-01

The aim of this research was to evaluate the effectiveness of a clinical instructional video with a structured worksheet for independent self-study in a complete denture program. 47 multilingual dental students completed a task by watching an instructional video with subtitles regarding clinical complete denture procedures. After completion, students evaluated their learning experience, and 11 students participated in focus group interviews to gain further insight. A mixed-methods approach to data collection and analysis provided descriptive statistical results and a grounded theory approach to coding identified key concepts and categories from the qualitative data. Over 70% of students had favorable opinions of the learning experience and indicated that the speed and length of the video were appropriate. Highly positive and conflicting negative comments regarding the use of subtitles showed both preferences for subtitles over audio and vice versa. The use of a video resource was considered valuable as the replay and review functions allowed better visualization of the procedures, which was considered a good recap tool for the clinical demonstration. It was also a better revision aid than textbooks. So, if the students were able to view these videos at will, they believed that videos supplemented their self-study. Despite the positive response, videos were not considered to replace live clinical demonstrations. While students preferred live demonstrations over the clinical videos they did express a realization of these as a supplemental learning material for self-study based on their ease of access, use for revision, and prior to clinical preparation. Copyright © 2015 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

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

PubMed

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

2003-01-01

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

A Summary of Evaluations for Learning and Attention Problems at a University Training Clinic

ERIC Educational Resources Information Center

Wierzbicki, Michael; Tyson, Clare M.

2007-01-01

Over a five year period, a university clinic performed psychological evaluations of 102 adults (including 85 college students) who reported that they were experiencing learning or attention problems. Of 92 persons who completed the evaluation, 40 (43.5%) received no diagnosis, 7 (7.6%) received the diagnosis of ADHD, 29 (31.5%) received the…

Clinical comparison and complete cure rates of Terbinafine efficacy in affected onychomycotic toenails.

PubMed

Shemer, A; Sakka, N; Baran, R; Scher, R; Amichai, B; Norman, L; Farhi, R; Magun, R; Brazilai, A; Daniel, R

2015-03-01

Clinical studies regarding complete cure rate of onychomycosis using oral Terbinafine have a very broad range (14-90%) based solely on response to treatment on the big toenail. To evaluate the efficacy of Terbinafine in all affected onychomycotic toenails and, furthermore, to evaluate differences in mycological, clinical and complete cure rate between affected onychomycotic toenails. Inclusion criteria are as follows: distolateralsubungual onychomycotic involvement of the hallux and additional involvement of at least two more toenails of the same foot. Exclusion criteria are as follows: patients with nail traumata and hypersensitivity to Terbinafine. Patients were treated with oral Terbinafine 250 mg/day for 16 weeks. Mycological analysis was performed using direct microscopy and culture. Clinical improvement was assessed using digital photography. Statistically significant difference was found in clinical improvement between the great toenail and all other involved toenails. The rate of complete cure (100% clinical cure and mycological cure) of the big toenail was lower (23%) as compared to the second (65%), third (51%) and the fourth toenail (67%). This is a case series study that was based on a single-centre cohort. Our results support findings that efficacy of Terbinafine should be based on all involved onychomycotic toenails; the big toenail is not superior in response compared to other affected toenails. © 2014 European Academy of Dermatology and Venereology.

The Danish Neuro-Oncology Registry: establishment, completeness and validity.

PubMed

Hansen, Steinbjørn; Nielsen, Jan; Laursen, René J; Rasmussen, Birthe Krogh; Nørgård, Bente Mertz; Gradel, Kim Oren; Guldberg, Rikke

2016-08-30

The Danish Neuro-Oncology Registry (DNOR) is a nationwide clinical cancer database that has prospectively registered data on patients with gliomas since January 2009. The purpose of this study was to describe the establishment of the DNOR and further to evaluate the database completeness of patient registration and validity of data. The completeness of the number of patients registered in the database was evaluated in the study period from January 2009 through December 2014 by comparing cases reported to the DNOR with the Danish National Patient Registry and the Danish Pathology Registry. The data validity of important clinical variables was evaluated by a random sample of 100 patients from the DNOR using the medical records as reference. A total of 2241 patients were registered in the DNOR by December 2014 with an overall patient completeness of 92 %, which increased during the study period (from 78 % in 2009 to 96 % in 2014). Medical records were available for all patients in the validity analyses. Most variables showed a high agreement proportion (56-100 %), with a fair to good chance-corrected agreement (k = 0.43-1.0). The completeness of patient registration was very high (92 %) and the validity of the most important patient data was good. The DNOR is a newly established national database, which is a reliable source for future scientific studies and clinical quality assessments among patients with gliomas.

Palliation of clinical signs in 48 dogs with nasal carcinomas treated with coarse-fraction radiation therapy.

PubMed

Gieger, Tracy; Rassnick, Kenneth; Siegel, Sheri; Proulx, David; Bergman, Philip; Anderson, Christine; LaDue, Tracy; Smith, Annette; Northrup, Nicole; Roberts, Royce

2008-01-01

Data from 48 dogs with nasal carcinomas treated with palliative radiation therapy (PRT) were retrospectively reviewed. Factors potentially influencing resolution of clinical signs and survival after PRT were evaluated. Clinical signs completely resolved in 66% of dogs for a median of 120 days. The overall median survival time was 146 days. Duration of response to PRT was shorter in dogs that had clinical signs for <90 days before PRT. Survival times were shorter in dogs that had partial or no resolution of clinical signs after PRT than in dogs that had complete resolution of clinical signs.

Second-Look Arthroscopic Assessment and Clinical Results of Modified Pull-Out Suture for Posterior Root Tear of the Medial Meniscus

PubMed Central

Song, Jae-Gwang

2014-01-01

Purpose To identify the structural integrity of the healing site after arthroscopic repair of a posterior root tear of the medial meniscus by second-look arthroscopy and to determine the clinical relevance of the findings. Materials and Methods From January 2005 to December 2010, 20 consecutive patients underwent arthroscopic modified pull-out suture repair for a posterior root tear of the medial meniscus. Thirteen patients were available for second-look arthroscopic evaluation. The healing status of the medial meniscus was classified as complete healing, lax healing, scar tissue healing, and failed healing. We evaluated the correlation between the clinical symptoms and second-look arthroscopic findings. Clinical evaluation was based on the Lysholm knee scores and Hospital for Special Surgery (HSS) scores. Results There were 4 cases of complete healing, 4 lax healing, 4 scar tissue healing, and 1 failed healing. The healing status of the repaired meniscus appeared to be related to the clinical symptoms. Patients who achieved complete tissue healing had no complaint. The healing status exhibited no relationship with age, mechanical axis, degree of subluxation, and symptom duration. The mean Lysholm score improved from 34.7 preoperatively to 75.6 at follow-up and the mean HSS score also significantly increased from 33.5 to 82.2. Conclusions We achieved 4 complete and 8 partial healing (lax or scar) of the medial meniscus in this retrospective case series of posterior horn meniscus root repairs performed by 1 surgeon. Further research is needed to clarify why all patients showed clinical improvement despite findings of partial healing on second-look arthroscopy. PMID:24944976

Simulation-Based Dysphagia Training: Teaching Interprofessional Clinical Reasoning in a Hospital Environment.

PubMed

Miles, Anna; Friary, Philippa; Jackson, Bianca; Sekula, Julia; Braakhuis, Andrea

2016-06-01

This study evaluated hospital readiness and interprofessional clinical reasoning in speech-language pathology and dietetics students following a simulation-based teaching package. Thirty-one students participated in two half-day simulation workshops. The training included orientation to the hospital setting, part-task skill learning and immersive simulated cases. Students completed workshop evaluation forms. They filled in a 10-question survey regarding confidence, knowledge and preparedness for working in a hospital environment before and immediately after the workshops. Students completed written 15-min clinical vignettes at 1 month prior to training, immediately prior to training and immediately after training. A marking rubric was devised to evaluate the responses to the clinical vignettes within a framework of interprofessional education. The simulation workshops were well received by all students. There was a significant increase in students' self-ratings of confidence, preparedness and knowledge following the study day (p < .001). There was a significant increase in student overall scores in clinical vignettes after training with the greatest increase in clinical reasoning (p < .001). Interprofessional simulation-based training has benefits in developing hospital readiness and clinical reasoning in allied health students.

Passive sensor technology interface to assess elder activity in independent living.

PubMed

Alexander, Gregory L; Wakefield, Bonnie J; Rantz, Marilyn; Skubic, Marjorie; Aud, Myra A; Erdelez, Sanda; Ghenaimi, Said Al

2011-01-01

The effectiveness of clinical information systems to improve nursing and patient outcomes depends on human factors, including system usability, organizational workflow, and user satisfaction. The aim of this study was to examine to what extent residents, family members, and clinicians find a sensor data interface used to monitor elder activity levels usable and useful in an independent living setting. Three independent expert reviewers conducted an initial heuristic evaluation. Subsequently, 20 end users (5 residents, 5 family members, 5 registered nurses, and 5 physicians) participated in the evaluation. During the evaluation, each participant was asked to complete three scenarios taken from three residents. Morae recorder software was used to capture data during the user interactions. The heuristic evaluation resulted in 26 recommendations for interface improvement; these were classified under the headings content, aesthetic appeal, navigation, and architecture, which were derived from heuristic results. Total time for elderly residents to complete scenarios was much greater than for other users. Family members spent more time than clinicians but less time than residents did to complete scenarios. Elder residents and family members had difficulty interpreting clinical data and graphs, experienced information overload, and did not understand terminology. All users found the sensor data interface useful for identifying changing resident activities. Older adult users have special needs that should be addressed when designing clinical interfaces for them, especially information as important as health information. Evaluating human factors during user interactions with clinical information systems should be a requirement before implementation.

A videotape series for teaching physicians to evaluate sexually abused children.

PubMed

Jones, Jerry G; Garrett, Judy; Worthington, Toss

2004-01-01

A free videotape subscription series was utilized to increase the knowledge of general physicians in clinical practice about the medical evaluation of sexually abused children. Of the 65 physicians who requested the first tape, 39 (60%) completed it. Fourteen of the 39 physicians who completed the first tape (36%) completed the 5-tape series. Completion data suggested that series completion was unrelated to prior knowledge, years since training or number of sexual abuse examinations performed in the previous year. Evaluative comments suggested that quality of the tapes was not a factor in completion rate. On tests of immediate retention, the average posttest percent correct was significantly higher than on the pretest. In a 3-year follow-up of the 14 physicians who completed the series, 10 reported that they were still performing sexual abuse examinations.

Management of Complete Talocrural Luxations by Selective Talocrural Arthrodesis using Hybrid Transarticular External Skeletal Fixation in Dogs.

PubMed

Yardımcı, Cenk; Önyay, Taylan; İnal, Kamil S; Özbakır, Deniz B; Özak, Ahmet

2018-06-16

 This article presents a novel surgical technique in the management of open complete talocrural luxations and evaluates the results, and clinical benefits with its routine clinical utilization.  Retrospective study.  Seventeen medium- or large-breed client-owned dogs of different breed, age and sex with complete talocrural luxations and radiographic follow-up of at least 24 weeks duration.  Selective talocrural arthrodesis was performed by using a hybrid transarticular external skeletal fixator frame. Clinical and radiographical evaluation was performed regarding the lesion, concomitant injury, duration of the surgery, time to first use of the limb, fixator removal time, complications and clinical outcomes.  Dogs started to use the injured limb between postoperative days 1 to 11. Pin or wire tract related complications were observed in all dogs. Time to fixator removal ranged from 57 to 90 days with a median of 73 days. All of the operated joints with an exception of one dog resulted in talocrural fusion. Mid-term clinical outcomes score was regarded as excellent in 13/17 dogs, good in 3/17 dogs and poor in 1/17 dogs subject to authors' evaluation.  A transarticular hybrid external fixator may allow early use of postoperative limb with an excellent patient compliance and is well tolerated as well. The technique showed a promising opportunity of providing favourable limb use. Schattauer GmbH Stuttgart.

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

PubMed

Jiang, Yuhua; Liu, Keyun; Li, Youxiang

2018-01-01

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

Associations of medical student personality and health/wellness characteristics with their medical school performance across the curriculum.

PubMed

Haight, Scott J; Chibnall, John T; Schindler, Debra L; Slavin, Stuart J

2012-04-01

To assess the relationships of cognitive and noncognitive performance predictors to medical student preclinical and clinical performance indicators across medical school years 1 to 3 and to evaluate the association of psychological health/wellness factors with performance. In 2010, the authors conducted a cross-sectional, correlational, retrospective study of all 175 students at the Saint Louis University School of Medicine who had just completed their third (first clinical) year. Students were asked to complete assessments of personality, stress, anxiety, depression, social support, and community cohesion. Performance measures included total Medical College Admission Test (MCAT) score, preclinical academic grades, National Board of Medical Examiners subject exam scores, United States Medical Licensing Examination Step 1 score, clinical evaluations, and Humanism in Medicine Honor Society nominations. A total of 152 students (87%) participated. MCAT scores predicted cognitive performance indicators (academic tests), whereas personality variables (conscientiousness, extraversion, empathy) predicted noncognitive indicators (clinical evaluations, humanism nominations). Conscientiousness predicted all clinical skills, extraversion predicted clinical skills reflecting interpersonal behavior, and empathy predicted motivation. Health/wellness variables had limited associations with performance. In multivariate analyses that included control for shelf exam scores, conscientiousness predicted clinical evaluations, and extraversion and empathy predicted humanism nominations. This study identified two sets of skills (cognitive, noncognitive) used during medical school, with minimal overlap across the types of performance (e.g., exam performance versus clinical interpersonal skills) they predict. Medical school admission and evaluation efforts may need to be modified to reflect the importance of personality and other noncognitive factors.

Use of anti-mullerian hormone for testing ovarian reserve: a survey of 796 infertility clinics worldwide.

PubMed

Tobler, Kyle J; Shoham, Gon; Christianson, Mindy S; Zhao, Yulian; Leong, Milton; Shoham, Zeev

2015-10-01

The aim of this study is to assess how anti-mullerian hormone (AMH) is used worldwide to test ovarian reserve and guide in vitro fertilization (IVF) cycle management. An internet-based survey was sent electronically to registered IVF providers within the IVF-Worldwide.com network. This survey consisted of nine questions which assessed the clinics' use of AMH. The questionnaire was completed online through the IVF-Worldwide.com website, and quality assurance tools were used to verify that only one survey was completed per clinical IVF center. Results are reported as the proportion of IVF cycles represented by a particular answer choice. Survey responses were completed from 796 globally distributed IVF clinics, representing 593,200 IVF cycles worldwide. Sixty percent of the respondent-IVF cycles reported to use AMH as a first line test, and 54 % reported it as the best test for evaluating ovarian reserve. Eighty-nine percent reported that AMH results were extremely relevant or relevant to clinical practice. However in contrast, for predicting live birth rate, 81 % reported age as the best predictor. AMH is currently considered a first line test for evaluating ovarian reserve and is considered relevant to clinical practice by the majority of IVF providers.

A mentor development program for clinical translational science faculty leads to sustained, improved confidence in mentoring skills.

PubMed

Feldman, Mitchell D; Steinauer, Jody E; Khalili, Mandana; Huang, Laurence; Kahn, James S; Lee, Kathryn A; Creasman, Jennifer; Brown, Jeanette S

2012-08-01

Mentorship is crucial for academic productivity and advancement for clinical and translational (CT) science faculty. However, little is known about the long-term effects of mentor training programs. The University of California, San Francisco (UCSF), Clinical and Translational Science Institute launched a Mentor Development Program (MDP) in 2007 for CT faculty. We report on an evaluation of the first three cohorts of graduates from the MDP. In 2010, all Mentors in Training (MITs) who completed the MDP from 2007 to 2009 (n= 38) were asked to complete an evaluation of their mentoring skills and knowledge; all MITs (100%) completed the evaluation. Two-thirds of MDP graduates reported that they often apply knowledge, attitudes, or skills obtained in the MDP to their mentoring. Nearly all graduates (97%) considered being a mentor important to their career satisfaction. Graduates were also asked about the MDP's impact on specific mentoring skills; 95% agreed that the MDP helped them to become a better mentor and to focus their mentoring goals. We also describe a number of new initiatives to support mentoring at UCSF that have evolved from the MDP. To our knowledge, this is the first evaluation of the long-term impact of a mentor training program for CT researchers. © 2012 Wiley Periodicals, Inc.

Who are medical marijuana patients? Population characteristics from nine California assessment clinics.

PubMed

Reinarman, Craig; Nunberg, Helen; Lanthier, Fran; Heddleston, Tom

2011-01-01

Marijuana is a currently illegal psychoactive drug that many physicians believe has substantial therapeutic uses. The medical literature contains a growing number of studies on cannabinoids as well as case studies and anecdotal reports suggesting therapeutic potential. Fifteen states have passed medical marijuana laws, but little is known about the growing population of patients who use marijuana medicinally. This article reports on a sample of 1,746 patients from a network of nine medical marijuana evaluation clinics in California. Patients completed a standardized medical history form; evaluating physicians completed standardized evaluation forms. From this data we describe patient characteristics, self-reported presenting symptoms, physician evaluations, other treatments tried, other drug use, and medical marijuana use practices. Pain, insomnia, and anxiety were the most common conditions for which evaluating physicians recommended medical marijuana. Shifts in the medical marijuana patient population over time, the need for further research, and the issue of diversion are discussed.

Evaluation of Electronic Health Record Implementation in Ophthalmology at an Academic Medical Center (An American Ophthalmological Society Thesis)

PubMed Central

Chiang, Michael F.; Read-Brown, Sarah; Tu, Daniel C.; Choi, Dongseok; Sanders, David S.; Hwang, Thomas S.; Bailey, Steven; Karr, Daniel J.; Cottle, Elizabeth; Morrison, John C.; Wilson, David J.; Yackel, Thomas R.

2013-01-01

Purpose: To evaluate three measures related to electronic health record (EHR) implementation: clinical volume, time requirements, and nature of clinical documentation. Comparison is made to baseline paper documentation. Methods: An academic ophthalmology department implemented an EHR in 2006. A study population was defined of faculty providers who worked the 5 months before and after implementation. Clinical volumes, as well as time length for each patient encounter, were collected from the EHR reporting system. To directly compare time requirements, two faculty providers who utilized both paper and EHR systems completed time-motion logs to record the number of patients, clinic time, and nonclinic time to complete documentation. Faculty providers and databases were queried to identify patient records containing both paper and EHR notes, from which three cases were identified to illustrate representative documentation differences. Results: Twenty-three faculty providers completed 120,490 clinical encounters during a 3-year study period. Compared to baseline clinical volume from 3 months pre-implementation, the post-implementation volume was 88% in quarter 1, 93% in year 1, 97% in year 2, and 97% in year 3. Among all encounters, 75% were completed within 1.7 days after beginning documentation. The mean total time per patient was 6.8 minutes longer with EHR than paper (P<.01). EHR documentation involved greater reliance on textual interpretation of clinical findings, whereas paper notes used more graphical representations, and EHR notes were longer and included automatically generated text. Conclusion: This EHR implementation was associated with increased documentation time, little or no increase in clinical volume, and changes in the nature of ophthalmic documentation. PMID:24167326

Clinician assessment for acute chest syndrome in febrile patients with sickle cell disease: is it accurate enough?

PubMed

Morris, C; Vichinsky, E; Styles, L

1999-07-01

To determine whether the use of empiric chest radiography (CXR) is of significant value in detecting clinically unsuspected acute chest syndrome (ACS) in febrile patients with sickle cell disease (SCD). Patients with SCD presenting to the emergency department and hematology clinic with temperature greater than or equal to 38 degrees C were prospectively evaluated using a physician-completed questionnaire. The questionnaire included inquiries into the patient's physical signs and symptoms and the physician's clinical impression for the presence of ACS. The questionnaire was completed before obtaining CXR results in all patients. Seventy-three patients with SCD with 96 febrile events were evaluated over a 1-year period. Twenty-four percent (23/96) of the patients had CXR evidence of ACS. On the basis of the questionnaire data, 61% (14/23) of ACS cases were not clinically suspected by the evaluating physician before obtaining CXR. Comparing the patients with and without ACS revealed that, with the exception of splinting (4/23 [17%] versus 0/73 [0%]), no symptom or physical examination finding helped to identify which patients had ACS. Fifty-seven percent of patients with ACS had completely normal findings on physical examination. The presentation of patients with clinically detected versus clinically unsuspected ACS also did not differ significantly. Length of hospitalization, oxygen use, and need for transfusion were the same in both the unsuspected and detected ACS groups. Overall physician sensitivity for predicting ACS was only 39%, and diagnostic accuracy did not improve significantly with increasing levels of pediatric training. ACS is common in patients with SCD who present with fever and was grossly underestimated by evaluating physicians. History and physical examination appear to be of little value in defining which febrile patients require CXR. In view of the mortality and morbidity associated with ACS, empiric CXR should be considered when evaluating a febrile patient with SCD.

Group Supervision Attitudes: Supervisory Practices Fostering Resistance to Adoption of Evidence-Based Practices

ERIC Educational Resources Information Center

Brooks, Charles T.; Patterson, David A.; McKiernan, Patrick M.

2012-01-01

The focus of this study was to qualitatively evaluate worker's attitudes about clinical supervision. It is believed that poor attitudes toward clinical supervision can create barriers during supervision sessions. Fifty-one participants within a social services organization completed an open-ended questionnaire regarding their clinical supervision…

Automating Collection of Pain-Related Patient-Reported Outcomes to Enhance Clinical Care and Research.

PubMed

Owen-Smith, Ashli; Mayhew, Meghan; Leo, Michael C; Varga, Alexandra; Benes, Lindsay; Bonifay, Allison; DeBar, Lynn

2018-05-01

Chronic pain is highly prevalent, and the ability to routinely measure patients' pain and treatment response using validated patient-reported outcome (PRO) assessments is important to clinical care. Despite this recognition, systematic use in everyday clinical care is rare. The aims of this study were to (1) describe infrastructure designed to automate PRO data collection, (2) compare study-enhanced PRO completion rates to those in clinical care, and (3) evaluate patient response rates by method of PRO administration and sociodemographic and/or clinical characteristics. The Pain Program for Active Coping and Training (PPACT) is a pragmatic clinical trial conducted within three regions of the Kaiser Permanente health care system. PPACT evaluates the effect of integrative primary care-based pain management services on outcomes for chronic pain patients on long-term opioid treatment. We implemented a tiered process for quarterly assessment of PROs to supplement clinical collection and ensure adequate trial data using three methods: web-based personal health records (PHR), automated interactive voice response (IVR) calls, and live outreach. Among a subset of PPACT participants examined (n = 632), the tiered study-enhanced PRO completion rates were higher than in clinical care: 96% completed ≥ 1 study-administered PRO with mean of 3.46 (SD = 0.85) vs. 74% completed in clinical care with a mean of 2.43 (SD = 2.08). Among all PPACT participants at 3 months (n = 831), PRO completion was 86% and analyses of response by key characteristics found only that participant age predicted an increased likelihood of responding to PHR and IVR outreach. Adherence to pain-related PRO data collection using our enhanced tiered approach was high. No demographic or clinical identifiers other than age were associated with differential response by modality. Successful ancillary support should employ multimodal electronic health record functionalities for PRO administration. Using automated modalities is feasible and may facilitate better sustainability for regular PRO administration within health care systems. Clinical Trials Registration Number: NCT02113592.

Changing Trends in the Clinical Presentation and Management of Complete Hydatidiform Mole Among Brazilian Women.

PubMed

Braga, Antonio; Moraes, Valéria; Maestá, Izildinha; Amim Júnior, Joffre; Rezende-Filho, Jorge de; Elias, Kevin; Berkowitz, Ross

2016-06-01

The aim of the study was to evaluate potential changes in the clinical, diagnostic, and therapeutic parameters of complete hydatidiform mole in the last 25 years in Brazil. A retrospective cohort study was conducted involving the analysis of 2163 medical records of patients diagnosed with complete hydatidiform mole who received treatment at the Rio de Janeiro Reference Center for Gestational Trophoblastic Disease between January 1988 and December 2012. For the statistical analysis of the natural history of the patients with complete molar pregnancies, time series were evaluated using the Cox-Stuart test and adjusted by linear regression models. A downward linear temporal trend was observed for gestational age of complete hydatidiform mole at diagnosis, which is also reflected in the reduced occurrence of vaginal bleeding, hyperemesis and pre-eclampsia. We also observed an increase in the use of uterine vacuum aspiration to treat molar pregnancy. Although the duration of postmolar follow-up was found to decline, this was not accompanied by any alteration in the time to remission of the disease or its progression to gestational trophoblastic neoplasia. Early diagnosis of complete hydatidiform mole has altered the natural history of molar pregnancy, especially with a reduction in classical clinical symptoms. However, early diagnosis has not resulted in a reduction in the development of gestational trophoblastic neoplasia, a dilemma that still challenges professionals working with gestational trophoblastic disease.

Radiopaque markers equal gastrografin in the study of small bowel obstructions (SBO): a preliminary study.

PubMed

Basile, Marco; Galica, Vikiela

2013-01-01

To compare the diagnostic accuracy of a consolidated method (i.e.gastrografin) and a new one (i.e.radiopaque markers) in detecting complete intestinal obstruction. Twenty-one patients with suspected small bowel obstruction were enrolled and received at admission orally 100 ml of Gastrografin and 10 radiopaque markers at the same time. A series of plain abdominal radiograms was taked and evaluated to decide whether the obstruction was complete or not. The results of radiological evaluations were not disclosed to the surgeons responsible for the patient's treatment, therefore clinical decisions were assumed on clinical grounds only. In 16 out of the 21 enrolled patients both methods demonstrated only a partial obstruction; clinically none of them required surgery. Five patients showed complete bowel obstruction by the radiopaque markers method; out of those the gastrografin study showed a complete obstruction in four of them. All of them were operated on. In the fifth case it was not clear if the gastrografin had passed through the ileum-cecal valve or not. The unclear clinical picture induced to perform a TC that revealed that a small quantity of gastrografin had passed the ileo-cecal valve but there was a complete small bowel occlusion due to an internal hernia requiring a surgical treatment (thus implying a false negative picture). This preliminary study showed that both methods are effective in the early diagnosis of complete SBO. The use of radiopaque markers could avoid some false negatives of the gastrografin method and is significantly less expensive.

Clinical evaluations of complete autologous fibrin glue, produced by the CryoSeal® FS system, and polyglycolic acid sheets as wound coverings after oral surgery.

PubMed

Kouketsu, Atsumu; Nogami, Shinnosuke; Yamada-Fujiwara, Minami; Nagai, Hirokazu; Yamauchi, Kensuke; Mori, Shiro; Miyashita, Hitoshi; Kawai, Tadashi; Matsui, Aritsune; Kataoka, Yoshihiro; Satomi, Norihisa; Ezoe, Yushi; Abe, Satoko; Takeda, Yuri; Tone, Takeshi; Hirayama, Bunnichi; Kurobane, Tsuyoshi; Tashiro, Kazuki; Yanagisawa, Yuta; Takahashi, Tetsu

2017-09-01

The CryoSeal ® FS System has been recently introduced as an automated device for the production of complete fibrin glue from autologous plasma, rather than from pool allogenic or cattle blood, to prevent viral infection and allergic reaction. We evaluated the effectiveness of complete autologous fibrin glue and polyglycolic acid (PGA) sheet wound coverings in mucosa defect oral surgery. Postoperative pain, scar contracture, ingestion, tongue dyskinesia, and postoperative bleeding were evaluated in 12 patients who underwent oral (including the tongue) mucosa excision, and received a PGA sheet and an autologous fibrin glue covering. They were compared with 12 patients who received a PGA sheet and commercial allogenic fibrin glue. All cases in the complete autologous fibrin glue group demonstrated good wound healing without complications such as local infection or incomplete cure. All evaluated clinical measures in this group were similar or superior to the commercial allogenic fibrin glue group. Coagulation and adhesion quality achieved with this method was comparable to that with a PGA sheet and commercial fibrin glue. Covering oral surgery wounds with complete autologous fibrin glue produced by an automated device was convenient, safe, and reduced the risk of viral infection and allergic reaction associated with conventional techniques. Copyright © 2017 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Doctor-office collaborative care for pediatric behavioral problems: a preliminary clinical trial.

PubMed

Kolko, David J; Campo, John V; Kilbourne, Amy M; Kelleher, Kelly

2012-03-01

To evaluate the feasibility and clinical benefits of an integrated mental health intervention (doctor-office collaborative care [DOCC]) vs enhanced usual care (EUC) for children with behavioral problems. Cases were assigned to DOCC and EUC using a 2:1 randomization schedule that resulted in 55 DOCC and 23 EUC cases. Preassessment was conducted in 4 pediatric primary care practices. Postassessment was conducted in the pediatric or research office. Doctor-office collaborative care was provided in the practice; EUC was initiated in the office but involved a facilitated referral to a local mental health specialist. Of 125 referrals (age range, 5-12 years), 78 children participated. Children and their parents were assigned to receive DOCC or EUC. Preassessment diagnostic status was evaluated using the Schedule for Affective Disorders and Schizophrenia for School-aged Children. Preassessment and 6-month postassessment ratings of behavioral and emotional problems were collected from parents using the Vanderbilt Attention-Deficit/Hyperactivity Disorder Diagnostic Parent Rating Scale, as well as individualized goal achievement ratings forms. At discharge, care managers and a diagnostic evaluator completed the Clinical Global Impression Scale, and pediatricians and parents completed satisfaction and study feedback measures. Group comparisons found significant improvements for DOCC over EUC in service use and completion, behavioral and emotional problems, individualized behavioral goals, and overall clinical response. Pediatricians and parents were highly satisfied with DOCC. The feasibility and clinical benefits of DOCC for behavioral problems support the integration of collaborative mental health services for common mental disorders in primary care.

Assessment of legibility and completeness of handwritten and electronic prescriptions.

PubMed

Albarrak, Ahmed I; Al Rashidi, Eman Abdulrahman; Fatani, Rwaa Kamil; Al Ageel, Shoog Ibrahim; Mohammed, Rafiuddin

2014-12-01

To assess the legibility and completeness of handwritten prescriptions and compare with electronic prescription system for medication errors. Prospective study. King Khalid University Hospital (KKUH), Riyadh, Saudi Arabia. Handwritten prescriptions were received from clinical units of Medicine Outpatient Department (MOPD), Primary Care Clinic (PCC) and Surgery Outpatient Department (SOPD) whereas electronic prescriptions were collected from the pediatric ward. The handwritten prescription was assessed for completeness by the checklist designed according to the hospital prescription and evaluated for legibility by two pharmacists. The comparison between handwritten and electronic prescription errors was evaluated based on the validated checklist adopted from previous studies. Legibility and completeness of prescriptions. 398 prescriptions (199 handwritten and 199 e-prescriptions) were assessed. About 71 (35.7%) of handwritten and 5 (2.5%) of electronic prescription errors were identified. A significant statistical difference (P < 0.001) was observed between handwritten and e-prescriptions in omitted dose and omitted route of administration category of error distribution. The rate of completeness in patient identification in handwritten prescriptions was 80.97% in MOPD, 76.36% in PCC and 85.93% in SOPD clinic units. Assessment of medication prescription completeness was 91.48% in MOPD, 88.48% in PCC, and 89.28% in SOPD. This study revealed a high incidence of prescribing errors in handwritten prescriptions. The use of e-prescription system showed a significant decline in the incidence of errors. The legibility of handwritten prescriptions was relatively good whereas the level of completeness was very low.

Evaluation of Physicians' Requests for Autopsies.

ERIC Educational Resources Information Center

Kesler, Richard W.; And Others

1983-01-01

Chaplains and seminary students enrolled in the University of Virginia Medical Center's Clinical Pastoral Program were asked to judge physicians' performances while requesting autopsies by completing a confidential evaluation form. The results of the evaluations were correlated with the physicians' success in obtaining autopsies. (MLW)

Clinical Effect of Acute Complete Acromioclavicular Joint Dislocation Treated with Micro-Movable and Anatomical Acromioclavicular Plate

PubMed Central

Liu, Qingjun; Miao, Jianyun; Lin, Bin; Guo, Zhimin

2012-01-01

Objectives: We evaluated the long-term clinical results of acute complete acromioclavicular dislocations treated with micro-movable and anatomical acromioclavicular plate. Methods: Open reduction and internal fixation was performed using the MAAP in 16 patients (10 males, 6 females; mean age 36 years; range16 to 63 years) with acute complete acromioclavicular joint dislocation. Radiographic evaluations were routinely conducted every 3 weeks until 3 months postoperatively. The MAAP were removed under local anesthesia after 3 months postoperatively. We evaluated the functional results by using the constant scoring system and radiological results in the last follow-up time. The mean follow up was 26 months (range 16 to 38 months). Results: The mean Constant score was 94 (range, 78 to 100). The results were excellent in 12 patients (75.0%), good in 3 patients (18.8%) and satisfactory in 1patient (6.2%). Three patients with scores of 80 to 90 had mild pain during activity, but have not affected the shoulder range of motion. One patient has both some pain and limited range of motion of shoulder joint. All patients but one have returned to their preoperative work without any limitations. Compared to the contralateral side, radiography showed anatomical reposition in the vertical plane in 14 cases, slight loss of reduction in 2 older patients. Conclusion: We recommend the MAAP fixation for surgical treatment of acute complete acromioclavicular joint dislocation as it could provide satisfactory shoulder functions and clinical results, with lower complication rate. However, it is necessary to continue to observe the clinical effects of this fixation technique. PMID:23091410

Clinical evaluation of the Novacor totally implantable ventricular assist system. Current status.

PubMed

Daniel, M A; Lee, J; LaForge, D H; Chen, H; Billich, J; Miller, P J; Ramasamy, N; Strauss, L R; Jassawalla, J S; Portner, P M

1991-01-01

The totally implantable Novacor left ventricular assist system (LVAS) is currently approaching clinical evaluation. In vivo testing and production are underway with National Institutes of Health (NIH) support. Activity over the past year has focused on manufacturing engineering, preproduction quality assurance, and in vivo experiment completion. Subsequent to successful completion of the NIH-sponsored, 2-year preclinical device readiness test (DRT), a number of refinements were identified and approved by the NIH technical/data review board. Most of these were necessitated by obsolescence or unavailability of electronic components and the decision to use only high reliability military (MIL) qualified electronic components and processes. A few additional refinements were identified to increase design margins, all of which were qualified by accelerated testing. The development of production processes, automated test programs, and MIL compliant environmental stress screening procedures was completed. Production of LVAS subsystems, including core electronic components (hybrids, application-specific integrated circuits, and surface mount boards), was initiated. Animal studies are underway. The clinical trial, at Presbyterian-University Hospital of Pittsburgh and St. Louis University Medical Center, awaits completion of in vivo experiments, protocol development, and Food and Drug Administration approval.

Ten-year NEDO BVAD development program: moving forward to the clinical arena.

PubMed

Motomura, Tadashi; Okubo, Hisashi; Oda, Takeshi; Ogawa, Daisuke; Okahisa, Toshiya; Igo, Stephen; Shinohara, Toshiyuki; Yamamoto, Yoshiro; Noguchi, Chikaya; Ishizuka, Tsukasa; Okamoto, Eiji; Nosé, Yukihiko

2006-01-01

Since 1995, the Baylor Group has been developing a totally implantable NEDO BVAD system. This 10-year program was completed in March 2005, and preparation for clinical trials is underway. This article summarizes the entire 10-year NEDO program and describes the strategy for clinical trials. The project aimed to achieve: (1) dual centrifugal pumps with the ability of full biventricular support, (2) a compact system implantable into small adults, (3) a totally implantable system with transcutaneous energy transmission system (TETS), (4) a durable system with a lifetime of over 5 years, and (5) a system free of thrombus and with minimal hemolysis. The final goals are to complete preclinical system evaluations and commence the clinical trials in the near future. In vitro studies have demonstrated a pump capacity of over 8.5 l/min and an Index of Hemolysis of <0.004 g/100 l. The pump-bearing life expectancy was over 5 years. To date, eight pumps endured in vivo studies of over 3 months without complications, including thromboembolic events. The in vitro endurance studies of eight pumps are longer than 1 year. There were no mechanical malfunctions or pump failure. A stepwise clinical trial is being planned: Step1, a wearable BVAD/VAD will be clinically studied; Step 2, the BVAD/VAD will be implanted intracorporeally without TETS; and, Step 3, a totally implantable system will be clinically evaluated. The NEDO BVAD system has completed preclinical testing. Clinical trial preparation is underway.

Evaluation of a Topical Anti-inflammatory/Antifungal Combination Cream in Mild-to-moderate Facial Seborrheic Dermatitis: An Intra-subject Controlled Trial Examining Treated vs. Untreated Skin Utilizing Clinical Features and Erythema-directed Digital Photography.

PubMed

Dall'Oglio, Federica; Tedeschi, Aurora; Guardabasso, Vincenzo; Micali, Giuseppe

2015-09-01

To evaluate if nonprescription topical agents may provide positive outcomes in the management of mild-to-moderate facial seborrheic dermatitis by reducing inflammation and scale production through clinical evaluation and erythema-directed digital photography. Open-label, prospective, not-blinded, intra-patient, controlled, clinical trial (target area). Twenty adult subjects affected by mild-to-moderate facial seborrheic dermatitis were enrolled and instructed to apply the study cream two times daily, initially on a selected target area only for seven days. If the subject developed visible improvement, it was advised to extend the application to all facial affected area for 21 additional days. Efficacy was evaluated by measuring the grade of erythema (by clinical examination and by erythema-directed digital photography), desquamation (by clinical examination), and pruritus (by subject-completed visual analog scale). Additionally, at the end of the protocol, a Physician Global Assessment was carried out. Eighteen subjects completed the study, whereas two subjects were lost to follow-up for nonadherence and personal reasons, respectively. Day 7 data from target areas showed a significant reduction in erythema. At the end of study, a significant improvement was recorded for erythema, desquamation, and pruritus compared to baseline. Physician Global Assessment showed improvement in 89 percent of patients, with a complete response in 56 percent of cases. These preliminary results indicate that the study cream may be a viable nonprescription therapeutic option for patients affected by facial seborrheic dermatitis able to determine early and significant improvement. This study also emphasizes the advantages of using an erythema-directed digital photography system for assisting in a simple, more accurate erythema severity grading and therapeutic monitoring in patients affected by seborrheic dermatitis.

Teaching evidence-based medical care: description and evaluation.

PubMed

Grad, R; Macaulay, A C; Warner, M

2001-09-01

This paper describes and evaluates several years of a seminar series designed to stimulate residents to seek evidence-based answers to their clinical questions and incorporate this evidence into practice. At the first session, 86 of 89 (97%) residents completed a baseline needs assessment questionnaire. Post-course self-assessment questionnaires measured change from the first to the final seminar session in six domains of interest and skill, as well as residents' preferred sources of information for clinical problem solving up to 2 years after the course. Before the seminars, 48% of residents reported that textbooks were their most important source of information for solving clinical problems. A total of 58 of 75 (77%) residents completed the first post-course questionnaire. Residents reported significant increases in skill at formulating clinical questions and searching for evidence-based answers, appraising reviews, and deciding when and how to incorporate new findings into practice. Use of secondary sources of information such as "Best Evidence," moved up in importance from before the course to after the course. First-year family practice residents who completed our seminar series have reported increased skill at blending consideration of a clinical problem with the use of secondary sources of information to access evidence to support their health care decisions.

Accuracy and completeness of drug information in Wikipedia medication monographs.

PubMed

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

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

[Clinical trial data management and quality metrics system].

PubMed

Chen, Zhao-hua; Huang, Qin; Deng, Ya-zhong; Zhang, Yue; Xu, Yu; Yu, Hao; Liu, Zong-fan

2015-11-01

Data quality management system is essential to ensure accurate, complete, consistent, and reliable data collection in clinical research. This paper is devoted to various choices of data quality metrics. They are categorized by study status, e.g. study start up, conduct, and close-out. In each category, metrics for different purposes are listed according to ALCOA+ principles such us completeness, accuracy, timeliness, traceability, etc. Some general quality metrics frequently used are also introduced. This paper contains detail information as much as possible to each metric by providing definition, purpose, evaluation, referenced benchmark, and recommended targets in favor of real practice. It is important that sponsors and data management service providers establish a robust integrated clinical trial data quality management system to ensure sustainable high quality of clinical trial deliverables. It will also support enterprise level of data evaluation and bench marking the quality of data across projects, sponsors, data management service providers by using objective metrics from the real clinical trials. We hope this will be a significant input to accelerate the improvement of clinical trial data quality in the industry.

[Intravaginal treatment of colpitis maculosa with an oestriol-containing vaginal cream (author's transl)].

PubMed

Schröck, A; Kofler, K; Baumgarten, K; Endl, J; Schmidt, J; Tatschl, S

1981-12-11

43 patients with colpitis maculosa (average age 60.2 years) were selected for an open control therapeutic study with Ortho-Gynest vaginal cream (Ortho-Cilag). The cream contains 0.5 mg of oestriol per single applicator filling. The treatment lasted from 3 to 4 weeks, success being evaluated by clinical documentation and cytological evaluation of vaginal smears before and after treatment. 10 patients (23.3%) were treated successfully, 29 (67.4%) showed a distinct improvement both clinically and cytologically, whilst the remaining 4 (9.3%) showed only moderate improvement. Hence, 39 patients (90.7%) were classified as having been successfully or partly successfully treated. Severe symptoms disappeared completely or were greatly alleviated in 91.4% cases. Moderate symptoms vanished in 59.7%. 58.1% showed a complete normalisation of the former atrophic vaginal skin. Blood spotting and reddening of the vaginal wall vanished completely. A change from dry to moist vagina occurred in 77.3% patients. Discharge vanished completely in 80.6% cases. No untoward side effects were recorded.

Prospective cohort pilot study of 2-visit CAD/CAM monolithic complete dentures and implant-retained overdentures: Clinical and patient-centered outcomes.

PubMed

Bidra, Avinash S; Farrell, Kimberly; Burnham, David; Dhingra, Ajay; Taylor, Thomas D; Kuo, Chia-Ling

2016-05-01

Presently, no studies have evaluated clinical outcomes or patient-centered outcomes for complete dentures fabricated with computer-aided design and computer aided manufacturing (CAD/CAM) technology. The purpose of this prospective cohort pilot study was to evaluate the clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated in 2 visits. Twenty participants with an existing set of maxillary complete dentures opposing either mandibular complete dentures or implant-retained overdentures that required replacement were recruited in this study. A 2-visit duplicate denture protocol was used to fabricate 40 arches of monolithic dentures with CAD/CAM technology. A 100-mm visual analog scale (VAS) instrument was then used to record 12 outcomes at baseline and at 1-year follow-up. Predetermined values were assigned to grade the VAS rating of each outcome as favorable (70.1-100) and unfavorable (≤70). Favorable ratings were sub-divided as excellent (90.1-100), good (80.1-90), and fair (70.1-80). The clinical outcomes were evaluated independently by 2 experienced prosthodontists at baseline and at 1-year follow-up. Patients evaluated the corresponding patient-centered outcomes during the same time intervals. Additional descriptive variables were also recorded. Each clinical and patient-centered outcome was summarized by medians and ranges. Differences in all ratings recorded at baseline and at 1 year were tested by 1-sided sign test (α=.05). Of 20 participants, 3 were lost to follow-up, and 3 were unsatisfied with the digital dentures and withdrew from the study. These 3 participants were considered treatment failures. Of the 14 remaining participants, 9 had implant-retained mandibular overdentures, and 5 had conventional mandibular complete dentures. For clinical outcomes, the 12 studied outcomes were favorably evaluated by the 2 prosthodontist judges at the 1-year follow-up. Evaluations showed minimal differences between baseline and 1 year. An average of 5 emails (0-11) per patient were sent to the laboratory technicians to communicate the improvisation the CAD design of the dentures. An average of 3.3 denture adjustments were needed after insertion (0-10) during the 1-year period. For patient-centered outcomes, median ratings of all 14 participants indicated each of the 12 studied outcomes was favorable at the 1-year recall. Statistically significant improvements in patient ratings from baseline to 1 year were observed for the absence of denture sore spots and treatment time to make the dentures (P<.05). Minor complications related to loss of retention, excessive wear of teeth and the need for additional visits were observed in 5 participants. No other adverse clinical outcomes related to the CAD/CAM dentures were noted in the 14 evaluated participants, and all dentures were intact and in good condition at the 1-year follow-up. Clinical and patient-centered outcomes for CAD/CAM monolithic dentures fabricated using a 2-visit protocol were evaluated favorably at a 1-year follow-up. However, the proportion of excellent and good ratings for overall satisfaction and assessment was higher for patients than clinicians. A considerable amount of the clinician's time and effort was devoted to aiding in the digital process for the fabrication of CAD/CAM dentures. Copyright © 2016 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

A Mentor Development Program for Clinical Translational Science Faculty Leads to Sustained, Improved Confidence in Mentoring Skills

PubMed Central

Feldman, Mitchell D.; Steinauer, Jody E.; Khalili, Mandana; Huang, Laurence; Kahn, James S.; Lee, Kathryn A.; Creasman, Jennifer; Brown, Jeanette S.

2012-01-01

Abstract Mentorship is crucial for academic productivity and advancement for clinical and translational (CT) science faculty. However, little is known about the long‐term effects of mentor training programs. The University of California, San Francisco (UCSF), Clinical and Translational Science Institute launched a Mentor Development Program (MDP) in 2007 for CT faculty. We report on an evaluation of the first three cohorts of graduates from the MDP. In 2010, all Mentors in Training (MITs) who completed the MDP from 2007 to 2009 (n= 38) were asked to complete an evaluation of their mentoring skills and knowledge; all MITs (100%) completed the evaluation. Two‐thirds of MDP graduates reported that they often apply knowledge, attitudes, or skills obtained in the MDP to their mentoring. Nearly all graduates (97%) considered being a mentor important to their career satisfaction. Graduates were also asked about the MDP's impact on specific mentoring skills; 95% agreed that the MDP helped them to become a better mentor and to focus their mentoring goals. We also describe a number of new initiatives to support mentoring at UCSF that have evolved from the MDP. To our knowledge, this is the first evaluation of the long‐term impact of a mentor training program for CT researchers. Clin Trans Sci 2012; Volume 5: 362–367 PMID:22883616

Teaching and evaluating point of care learning with an Internet-based clinical-question portfolio.

PubMed

Green, Michael L; Reddy, Siddharta G; Holmboe, Eric

2009-01-01

Diplomates in the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) program satisfy the self-evaluation of medical knowledge requirement by completing open-book multiple-choice exams. However, this method remains unlikely to affect practice change and often covers content areas not relevant to diplomates' practices. We developed and evaluated an Internet-based point of care (POC) learning portfolio to serve as an alternative. Participants enter information about their clinical questions, including characteristics, information pursuit, application, and practice change. After documenting 20 questions, they reflect upon a summary report and write commitment-to-change statements about their learning strategies. They can link to help screens and medical information resources. We report on the beta test evaluation of the module, completed by 23 internists and 4 internal medicine residents. Participants found the instructions clear and navigated the module without difficulty. The majority preferred the POC portfolio to multiple-choice examinations, citing greater relevance to their practice, guidance in expanding their palette of information resources, opportunity to reflect on their learning needs, and "credit" for self-directed learning related to their patients. Participants entered a total of 543 clinical questions, of which 250 (46%) resulted in a planned practice change. After completing the module, 14 of 27 (52%) participants committed to at least 1 change in their POC learning strategies. Internists found the portfolio valuable, preferred it to multiple-choice examinations, often changed their practice after pursuing clinical questions, and productively reflected on their learning strategies. The ABIM will offer this portfolio as an elective option in MOC.

Clinical assessment and management of general surgery patients via synchronous telehealth.

PubMed

Cain, Steven M; Moore, Robert; Sturm, Lauren; Mason, Travis; Fuhrman, Caitlin; Smith, Robin; Bojicic, Irfan; Carter, Brandon

2017-02-01

Objective This paper describes how a clinical team at Landstuhl Regional Medical Center (LRMC) successfully integrated synchronous telehealth (TH) into their routine clinical practice. Methods and materials Synchronous TH encounters were performed using Polycom® software on surgeons' computers with high-definition (HD) cameras on monitors at distant sites and PolyCom HDX9000® Telehealth Practitioner Carts at originating sites. Patients provided consented and were presented to general surgeons by nurses and medical technicians at Army health clinics throughout the European Theater. Results In calendar year (CY) 2014, five general surgeons and two surgical physician assistants (PAs) at Landstuhl Regional Medical Center along with registered nurses (RNs) at six originating clinic sites throughout Europe completed 130 synchronous TH encounters for 101 general surgery patients resulting in 73 completed and 16 recommended surgeries. Eighty-eight percent of patients had a completed or recommended surgery. No surgeries or procedures planned after initial TH evaluation were cancelled. Originating site clinics ranged in distance from 68 miles to 517 miles. Acceptance by providers, patients and clinic staff was high. Conclusion Synchronous TH was effective and safe in evaluating common general surgical conditions. We excluded sensitive and complex conditions requiring a nuanced physical examination. The TH efforts of the general surgery staff have resulted in high-quality, seamless and predictable TH activities that continue to expand into other surgical and medical specialties beyond general surgery. Seven surgeons and two PAs use synchronous TH regularly serving patients over a broad geographic area.

Assessment of legibility and completeness of handwritten and electronic prescriptions

PubMed Central

Albarrak, Ahmed I; Al Rashidi, Eman Abdulrahman; Fatani, Rwaa Kamil; Al Ageel, Shoog Ibrahim; Mohammed, Rafiuddin

2014-01-01

Objectives To assess the legibility and completeness of handwritten prescriptions and compare with electronic prescription system for medication errors. Design Prospective study. Setting King Khalid University Hospital (KKUH), Riyadh, Saudi Arabia. Subjects and methods Handwritten prescriptions were received from clinical units of Medicine Outpatient Department (MOPD), Primary Care Clinic (PCC) and Surgery Outpatient Department (SOPD) whereas electronic prescriptions were collected from the pediatric ward. The handwritten prescription was assessed for completeness by the checklist designed according to the hospital prescription and evaluated for legibility by two pharmacists. The comparison between handwritten and electronic prescription errors was evaluated based on the validated checklist adopted from previous studies. Main outcome measures Legibility and completeness of prescriptions. Results 398 prescriptions (199 handwritten and 199 e-prescriptions) were assessed. About 71 (35.7%) of handwritten and 5 (2.5%) of electronic prescription errors were identified. A significant statistical difference (P < 0.001) was observed between handwritten and e-prescriptions in omitted dose and omitted route of administration category of error distribution. The rate of completeness in patient identification in handwritten prescriptions was 80.97% in MOPD, 76.36% in PCC and 85.93% in SOPD clinic units. Assessment of medication prescription completeness was 91.48% in MOPD, 88.48% in PCC, and 89.28% in SOPD. Conclusions This study revealed a high incidence of prescribing errors in handwritten prescriptions. The use of e-prescription system showed a significant decline in the incidence of errors. The legibility of handwritten prescriptions was relatively good whereas the level of completeness was very low. PMID:25561864

Obstetrics and gynecology clerkship for males and females: similar curriculum, different outcomes?

PubMed Central

Craig, LaTasha B.; Smith, Chad; Crow, Sheila M.; Driver, Whitney; Wallace, Michelle; Thompson, Britta M.

2013-01-01

Objective To determine if performance differences exist between male and female students on a 6-week obstetrics and gynecology (Ob/Gyn) clerkship and to evaluate potential variables that might underlie any observed variations. Study Design Final clerkship grades and component scores (clinical evaluations, objective structured clinical examination [OSCE], oral examination, and National Board of Medical Examiners [NBME] subject examination) from July 2007 to June 2010 were matched by student and analyzed by gender. Basic science grade point average (GPA) and initial United States Medical Licensing Exam (USMLE) Step 1 scores were used to establish students’ baseline medical knowledge. On a post-clerkship questionnaire, a subset of students reported the numbers of procedures they performed during the clerkship; students also completed online pre- and post-clerkship questionnaires reflecting their self-assessed confidence in women's health clinical skills. Results Scores were analyzed for 136 women and 220 men. Final clerkship grades were significantly higher for females than for males (89.05 vs. 87.34, p=0.0004, η 2=0.08). Specifically, females outscored males on the OSCE, oral, and NBME subject examination portions of the clerkship but not clinical evaluations. Males reported completing fewer breast examinations (p=0.001, η 2=0.14). Pre-clerkship, males were significantly less confident than females in women's health clinical skills (p<0.01) but reached similar levels upon completion of the clerkship. No gender differences were detected for basic science GPA and USMLE Step 1 scores. Conclusion Student gender is associated with final grades on an Ob/Gyn clerkship. Further research regarding these differences should be explored. PMID:24300748

Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free Online.

PubMed

Elison, Sarah; Jones, Andrew; Ward, Jonathan; Davies, Glyn; Dugdale, Stephanie

2017-11-01

When evaluating complex, tailorable digital behavioural interventions, additional approaches may be required alongside established methodologies such as randomised controlled trials (RCTs). Research evaluating a computer-assisted therapy (CAT) programme for substance misuse, Breaking Free Online (BFO), is informed by Medical Research Council (MRC) guidance recommending examination of 'mechanisms of action' of individual intervention strategies, which is relevant when evaluating digital interventions with content that may evolve over time. To report findings from examination of mechanisms of action of tailoring advice within the BFO programme and outcomes from specific intervention strategies. Analysis of covariance and linear regressions were used to assess intervention completion data, and psychometric and clinical outcomes, for 2311 service users accessing drug and alcohol treatment services across the UK. Tailoring advice provided to users appeared to prompt them to prioritise completion of intervention strategies associated with their areas of highest biopsychosocial impairment. Completion of specific intervention strategies within BFO were associated with specific clinical outcomes, with a dose response also being found. Mechanisms of action analyses revealed the primacy of cognitions, with cognitive restructuring strategies being associated with improvements in mental health, severity of substance dependence, quality of life and global biopsychosocial functioning. The MRC framework provides an evolved research paradigm within the field of digital behavioural change. By assessing baseline profiles of need, BFO can target the most appropriate clinical content for individual users. Mechanisms of action research can be used to inform modifications to BFO to continually update clinical content and the technology platform. Copyright © 2017 Elsevier Ltd. All rights reserved.

Tobacco dependence counseling in a randomized multisite clinical trial

PubMed Central

Croghan, Ivana T.; Trautman, Judith A.; Winhusen, Theresa; Ebbert, Jon O.; Kropp, Frankie; Schroeder, Darrell R.; Hurt, Richard D.

2012-01-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a “train-the-trainer” model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3 ± 2.8 sessions (mean ± SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and “meeting expectations” on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. PMID:22406192

Tobacco dependence counseling in a randomized multisite clinical trial.

PubMed

Croghan, Ivana T; Trautman, Judith A; Winhusen, Theresa; Ebbert, Jon O; Kropp, Frankie B; Schroeder, Darrell R; Hurt, Richard D

2012-07-01

Pharmacotherapy trials for treating tobacco dependence would benefit from behavioral interventions providing treatment consistent with clinical practice guidelines but not directing participants to treatments not evaluated in the trial. The Smoke Free and Living It© behavioral intervention manual includes participant and interventionist guides and is designed to provide both practical counseling and intra-treatment support. We utilized this intervention manual in a multicenter, randomized clinical trial of smokers with attention deficit hyperactivity disorder. In this study, we evaluated how the interventional manual performed in a "train-the-trainer" model requiring uniform counseling across 6 sites and 15 interventionists. We analyzed the skill-adherence of the interventionists and the intervention-adherence of the participants. The 255 randomized participants completed 9.3±2.8 sessions (mean±SD), with 157 participants (61.6%) completing all 11 of the sessions and 221 (86.7%) completing at least 6 of the 11 sessions. Of the 163 sessions for which the study interventionists were evaluated, 156 (95.7%) were rated as adherent to protocol and "meeting expectations" on at least 6 of 7 established criteria, illustrating that fidelity can be maintained with minimal supervision. The self-help and interventionists guides of the Smoke Free and Living It manual can thus be used to provide behavioral intervention with a high rate of adherence by both the interventionists and the participants. This manual meets the requirements of the United States Public Health Service Clinical Practice Guideline, can be adapted to specific research protocols, and provides a useful option for behavioral intervention during clinical trials for smoking cessation. Copyright © 2012 Elsevier Inc. All rights reserved.

[The 'Beijing clinical database' on severe acute respiratory syndrome patients: its design, process, quality control and evaluation].

PubMed

2004-04-01

To develop a large database on clinical presentation, treatment and prognosis of all clinical diagnosed severe acute respiratory syndrome (SARS) cases in Beijing during the 2003 "crisis", in order to conduct further clinical studies. The database was designed by specialists, under the organization of the Beijing Commanding Center for SARS Treatment and Cure, including 686 data items in six sub-databases: primary medical-care seeking, vital signs, common symptoms and signs, treatment, laboratory and auxiliary test, and cost. All hospitals having received SARS inpatients were involved in the project. Clinical data was transferred and coded by trained doctors and data entry was carried out by trained nurses, according to a uniformed protocol. A series of procedures had been taken before the database was finally established which included programmed logic checking, digit-by-digit check on 5% random sample, data linkage for transferred cases, coding of characterized information, database structure standardization, case reviewe by computer program according to SARS Clinical Diagnosis Criteria issued by the Ministry of Health, and exclusion of unqualified patients. The database involved 2148 probable SARS cases in accordant with the clinical diagnosis criteria, including 1291 with complete records. All cases and record-complete cases showed an almost identical distribution in sex, age, occupation, residence areas and time of onset. The completion rate of data was not significantly different between the two groups except for some items on primary medical-care seeking. Specifically, the data completion rate was 73% - 100% in primary medical-care seeking, 90% in common symptoms and signs, 100% for treatment, 98% for temperature, 90% for pulse, 100% for outcomes and 98% for costs in hospital. The number of cases collected in the Beijing Clinical Database of SARS Patients was fairly complete. Cases with complete records showed that they could serve as excellent representatives of all cases. The completeness of data was quite satisfactory with primary clinical items which allowed for further clinical studies.

eHealth System for Collecting and Utilizing Patient Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) Among Cancer Patients: Mixed Methods Approach to Evaluate Feasibility and Acceptability.

PubMed

Girgis, Afaf; Durcinoska, Ivana; Levesque, Janelle V; Gerges, Martha; Sandell, Tiffany; Arnold, Anthony; Delaney, Geoff P

2017-10-02

Despite accumulating evidence indicating that collecting patient-reported outcomes (PROs) and transferring results to the treating health professional in real time has the potential to improve patient well-being and cancer outcomes, this practice is not widespread. The aim of this study was to test the feasibility and acceptability of PROMPT-Care (Patient Reported Outcome Measures for Personalized Treatment and Care), a newly developed electronic health (eHealth) system that facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. We developed an eHealth system in consultation with content-specific expert advisory groups and tested it with patients receiving treatment or follow-up care in two hospitals in New South Wales, Australia, over a 3-month period. Participants were recruited in clinic and completed self-report Web-based assessments either just before their upcoming clinical consultation or every 4 weeks if in follow-up care. A mixed methods approach was used to evaluate feasibility and acceptability of PROMPT-Care; data collected throughout the study informed the accuracy and completeness of data transfer procedures, and extent of missing data was determined from participants' assessments. Patients participated in cognitive interviews while completing their first assessment and completed evaluation surveys and interviews at study-end to assess system acceptability and usefulness of patient self-management resources, and oncology staff were interviewed at study-end to determine the acceptability and perceived usefulness of real-time PRO reporting. A total of 42 patients consented to the study; 7 patients were withdrawn before starting the intervention primarily because of changes in eligibility. Overall, 35 patients (13 on treatment and 22 in follow-up) completed 67 assessments during the study period. Mean completeness of patient-reported data was 93%, with 100% accuracy of data transfer. Ten patients completed cognitive interviews, 28 completed evaluation surveys, and 14 completed evaluation interviews at study-end. PROMPT-Care patient acceptability was high-100% (28/28) reported the time to complete the Web-based assessments (average 15 min) as about right, most willing to answer more questions (79%, 22/28 yes), 96% (27/28) found the Web-based assessment easier or same as completing a paper copy, and they valued the self-management resources . Oncology staff (n=5) also reported high acceptability and potential feasibility of the system. Patients and oncology staff found the PROMPT-Care system to be highly acceptable, and the results suggest that it would be feasible to implement it into an oncology setting. Suggested modifications to the patient assessment survey, clinician access to the reports, and system requirements will be made as part of the next stage of large-scale testing and future implementation of the system as part of routine care. Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0). ©Afaf Girgis, Ivana Durcinoska, Janelle V Levesque, Martha Gerges, Tiffany Sandell, Anthony Arnold, Geoff P Delaney, The PROMPT-Care Program Group. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 02.10.2017.

Completeness and accuracy of the wisconsin immunization registry: an evaluation coinciding with the beginning of meaningful use.

PubMed

Koepke, Ruth; Petit, Ashley B; Ayele, Roman A; Eickhoff, Jens C; Schauer, Stephanie L; Verdon, Matthew J; Hopfensperger, Daniel J; Conway, James H; Davis, Jeffrey P

2015-01-01

Vaccination coverage rates can be improved through the application of complete and accurate immunization information systems (IISs). Evaluate the completeness and accuracy of Wisconsin's IIS, the Wisconsin Immunization Registry (WIR). Cross-sectional evaluation, comparing vaccination medical records (MRs) from provider clinics with WIR records. Medical records of patients born during 2009 were randomly selected from 251 Wisconsin clinics associated with the Vaccines for Children Program. Completeness: percentage of patients with client records in the WIR, percentage of patients up-to-date (%UTD) with the 4:3:1:3:3:1:4 vaccination series, and percentage of patients' MR vaccinations matched by administration date (±10 days) and type to vaccinations documented in the WIR. Accuracy: percentages of matched vaccinations with the same administration date, same trade name (TN), and same lot number. Of the 1863 selected patient MRs, 98% (n = 1833) had WIR client records and 97% of their 30 899 vaccinations were documented in the WIR. The %UTD was 49.3% using the MR only, 76.5% using the WIR only, and 75.2% as estimated by the National Immunization Survey. Among matched vaccinations, 99% had the same administration date, 96% had the same TN, and 95% had the same lot number. Compared with patients from clinics that entered data into the WIR using data exchange from electronic health records, patients from clinics that entered data using the Web-based user interface were less likely to have client records in the WIR (odds ratio: 0.3; 95% confidence interval: 0.1-0.9) and less likely to have accurate TNs (odds ratio: 0.3; 95% confidence interval: 0.1-0.5). The WIR was complete and accurate among this sample of children born during 2009 and provided a vaccination coverage assessment similar to the National Immunization Survey. Our results provide support for the expectation that meaningful use and other initiatives that increase data exchange from electronic health records to IISs will improve IIS data quality.

Review of outcomes from a change in faculty clinic management in a U.S. dental school.

PubMed

Nadershahi, Nader A; Salmon, Eric S; Fathi, Nava; Schmedders, Karl; Hargis, Jace

2010-09-01

Dental schools use a variety of clinic management models with the goals of promoting patient care, student education, and fiscal responsibility. In 2004, the University of the Pacific Arthur A. Dugoni School of Dentistry transitioned to a more generalist model with these goals in mind. The purpose of this study was to evaluate the outcomes of this clinic model change relative to the quantity of specific procedures completed by students. The quantity of procedures completed by each student from the classes of 1995 through 2009 were compiled from our electronic clinic management system and analyzed. The post-transition group (2004-09) showed a greater number of completed oral diagnosis and treatment planning and root planing procedures per student compared to the pre-transition group (1995-2003), but fewer crowns, root canals, operative procedures, and dentures. Because the higher procedure numbers were for low-cost procedures, our transition to a generalist model did not necessarily enhance clinic income but may support student learning and enhanced patient care.

The importance of a two-step impression procedure for complete denture fabrication: a systematic review of the literature.

PubMed

Regis, R R; Alves, C C S; Rocha, S S M; Negreiros, W A; Freitas-Pontes, K M

2016-10-01

The literature has questioned the real need for some clinical and laboratory procedures considered essential for achieving better results for complete denture fabrication. The aim of this study was to review the current literature concerning the relevance of a two-step impression procedure to achieve better clinical results in fabricating conventional complete dentures. Through an electronic search strategy of the PubMed/MEDLINE database, randomised controlled clinical trials which compared complete denture fabrication in adults in which one or two steps of impressions occurred were identified. The selections were made by three independent reviewers. Among the 540 titles initially identified, four studies (seven published papers) reporting on 257 patients evaluating aspects such as oral health-related quality of life, patient satisfaction with dentures in use, masticatory performance and chewing ability, denture quality, direct and indirect costs were considered eligible. The quality of included studies was assessed according to the Cochrane guidelines. The clinical studies considered for this review suggest that a two-step impression procedure may not be mandatory for the success of conventional complete denture fabrication regarding a variety of clinical aspects of denture quality and patients' perceptions of the treatment. © 2016 John Wiley & Sons Ltd.

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

PubMed

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

2010-01-01

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

Electronic laboratory data quality and the value of a health information exchange to support public health reporting processes.

PubMed

Dixon, Brian E; McGowan, Julie J; Grannis, Shaun J

2011-01-01

There is increasing interest in leveraging electronic health data across disparate sources for a variety of uses. A fallacy often held by data consumers is that clinical data quality is homogeneous across sources. We examined one attribute of data quality, completeness, in the context of electronic laboratory reporting of notifiable disease information. We evaluated 7.5 million laboratory reports from clinical information systems for their completeness with respect to data needed for public health reporting processes. We also examined the impact of health information exchange (HIE) enhancement methods that attempt to improve completeness. The laboratory data were heterogeneous in their completeness. Fields identifying the patient and test results were usually complete. Fields containing patient demographics, patient contact information, and provider contact information were suboptimal. Data processed by the HIE were often more complete, suggesting that HIEs can support improvements to existing public health reporting processes.

Preterm birth: Case definition & guidelines for data collection, analysis, and presentation of immunisation safety data.

PubMed

Quinn, Julie-Anne; Munoz, Flor M; Gonik, Bernard; Frau, Lourdes; Cutland, Clare; Mallett-Moore, Tamala; Kissou, Aimee; Wittke, Frederick; Das, Manoj; Nunes, Tony; Pye, Savia; Watson, Wendy; Ramos, Ana-Maria Alguacil; Cordero, Jose F; Huang, Wan-Ting; Kochhar, Sonali; Buttery, Jim

2016-12-01

Preterm birth is commonly defined as any birth before 37 weeks completed weeks of gestation. An estimated 15 million infants are born preterm globally, disproportionately affecting low and middle income countries (LMIC). It contributes directly to estimated one million neonatal deaths annually and is a significant contributor to childhood morbidity. However, in many clinical settings, the information available to calculate completed weeks of gestation varies widely. Accurate dating of the last menstrual period (LMP), as well as access to clinical and ultrasonographic evaluation are important components of gestational age assessment antenatally. This case definition assign levels of confidence to categorisation of births as preterm, utilising assessment modalities which may be available across different settings. These are designed to enable systematic safety evaluation of vaccine clinical trials and post-implementation programmes of immunisations in pregnancy. Copyright © 2016. Published by Elsevier Ltd.

Efficacy and Safety of Naftifine HCl Cream 2% in the Treatment of Pediatric Subjects With Tinea Corporis.

PubMed

Gold, Michael; Dhawan, Sunil; Verma, Amit; Kuligowski, Michael; Dobrowski, David

2016-06-01

Tinea corporis is fungal infection of body surfaces other than the feet, groin, scalp, or beard. Naftifine hydrochloride is a topical antifungal of the allylamine class used to treat tinea corporis, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects.
To evaluate the efficacy and safety of two-weeks once daily application of naftifine cream 2% in the treatment of tinea corporis among pediatric subjects.
At baseline, 231 subjects were randomly assigned 1:1 to naftifine cream 2% (n=116) and vehicle (n=115). Treatment effect consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline, week 2 (end of treatment) and week 3. Efficacy was analyzed in 181 subjects (n=88, naftifine; n=93, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 3 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 231 subjects (n=116, naftifine; n=115, vehicle).
Children with tinea corporis treated with naftifine cream 2% demonstrated significantly greater improvements from baseline over vehicle for mycological cure (P<0.0001) and treatment effectiveness (P=0.003) as early as 2 weeks (end of treatment). Response rates continued to increase post-treatment and were the highest 1-week after completion of the therapy (P=0.003 for complete cure; and P<0.001 for mycological cure and treatment effectiveness). Treatment related adverse events were minimal.
Treatment with naftifine cream 2% applied once daily for two weeks was well-tolerated and was effective in treating tinea corporis in children. Further improvement was observed 1-week after treatment completion for all key outcome measures (complete cure, mycological cure, treatment effectiveness, clinical cure, and clinical success) and clinical signs and symptoms (erythema, induration, and pruritus).

J Drugs Dermatol. 2016;15(6):743-748.

Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group.

PubMed

Provenzano, Elena; Bossuyt, Veerle; Viale, Giuseppe; Cameron, David; Badve, Sunil; Denkert, Carsten; MacGrogan, Gaëtan; Penault-Llorca, Frédérique; Boughey, Judy; Curigliano, Giuseppe; Dixon, J Michael; Esserman, Laura; Fastner, Gerd; Kuehn, Thorsten; Peintinger, Florentia; von Minckwitz, Gunter; White, Julia; Yang, Wei; Symmans, W Fraser

2015-09-01

Neoadjuvant systemic therapy is being used increasingly in the treatment of early-stage breast cancer. Response, in the form of pathological complete response, is a validated and evaluable surrogate end point of survival after neoadjuvant therapy. Thus, pathological complete response has become a primary end point for clinical trials. However, there is a current lack of uniformity in the definition of pathological complete response. A review of standard operating procedures used by 28 major neoadjuvant breast cancer trials and/or 25 sites involved in such trials identified marked variability in specimen handling and histologic reporting. An international working group was convened to develop practical recommendations for the pathologic assessment of residual disease in neoadjuvant clinical trials of breast cancer and information expected from pathology reports. Systematic sampling of areas identified by informed mapping of the specimen and close correlation with radiological findings is preferable to overly exhaustive sampling, and permits taking tissue samples for translational research. Controversial areas are discussed, including measurement of lesion size, reporting of lymphovascular space invasion and the presence of isolated tumor cells in lymph nodes after neoadjuvant therapy, and retesting of markers after treatment. If there has been a pathological complete response, this must be clearly stated, and the presence/absence of residual ductal carcinoma in situ must be described. When there is residual invasive carcinoma, a comment must be made as to the presence/absence of chemotherapy effect in the breast and lymph nodes. The Residual Cancer Burden is the preferred method for quantifying residual disease in neoadjuvant clinical trials in breast cancer; other methods can be included per trial protocols and regional preference. Posttreatment tumor staging using the Tumor-Node-Metastasis system should be included. These recommendations for standardized pathological evaluation and reporting of neoadjuvant breast cancer specimens should improve prognostication for individual patients and allow comparison of treatment outcomes within and across clinical trials.

Predicting factors of fistula healing and clinical remission after infliximab-based combined therapy for perianal fistulizing Crohn's disease.

PubMed

Tougeron, David; Savoye, Guillaume; Savoye-Collet, Céline; Koning, Edith; Michot, Francis; Lerebours, Eric

2009-08-01

Perianal fistulizing Crohn's disease (PFCD) treatment is based on fistula drainage, antibiotics, immunosuppressant (IS) drugs, and infliximab. Our aim was to study the effectiveness of combination therapy on PFCD and to search for clinical or imaging features associated with the initial complete clinical response and its stability overtime. All patients with PFCD treated in our tertiary center between 2000 and 2005 by infliximab in combination with seton placement and/or IS and evaluated by MRI before treatment were included in the study. Basal clinical and MRI characteristics were recorded. Response to treatment was evaluated after the infliximab induction regiment and at the end of the follow-up. Twenty-six patients were included and followed-up for an average 4.9 years. A complex fistula was present in 69% (18/26 patients) of cases and eight (8/26 patients) had an ano-vaginal fistula. After infliximab induction therapy, 13 patients (50%) achieved a complete clinical response. The initial clinical response was significantly associated with the absence of both, active intestinal disease (54% vs. 8%, P = 0.03) and active proctitis (77% vs. 23%, P = 0.01). No initial MRI characteristics were linked to the initial response. In multivariate analysis, only the presence of active proctitis was associated with the lack of response (P = 0.047). At the end of the follow-up, 42% of the patients remained in clinical remission. No clinical characteristics were associated to sustained response when among long-standing responders two exhibited a normal post-treatment MRI. An initial complete response of PFCD was observed in half of the patients after combined therapy including infliximab that decreased to 42% later on. Complete healing of fistulas on MRI was possible but unusual. The initial response seemed related to the absence of active intestinal disease, especially in the rectum, when the long-term response could not be predicted by the basal characteristics of patients.

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

PubMed Central

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

2014-01-01

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

Surgical clinical correlates in anatomy: design and implementation of a first-year medical school program.

PubMed

Haubert, Lisa M; Jones, Kenneth; Moffatt-Bruce, Susan D

2009-01-01

Medical students state the need for a clinically oriented anatomy class so to maximize their learning experience. We hypothesize that the first-year medical students, who take the Surgical Clinical Correlates in Anatomy program, will perform better than their peers in their anatomy course, their surgical clerkships and ultimately choose surgical residencies. We designed and recently implemented this program for first-year medical students. It consisted of General Surgical Knowledge, Orthopedic Surgery, Plastic Surgery, Urology, Cardiothoracic Surgery, General Surgery, Vascular Surgery, and Ear, Nose, and Throat (ENT) sessions. Each session had defined learning objectives and interactive cadaveric operations performed by faculty members and students. The program was elective and had 25 participants randomly chosen. An evaluative questionnaire was completed before and after the program. Comparative analysis of the questionnaires, first-year anatomy examination results, clinical surgical rotation scores, and residency match results will be completed. The positive opinions of surgeons increased for all medical students from the pre-evaluation to the post-evaluation, and there was a greater increase in positive opinions for our participants. Our participants also had the highest average overall for all combined anatomy examinations. A need exists among medical students to develop a clinically correlated anatomy program that will maximize their learning experience, improve their performance and allow them to make moreinformed career choices. The recent implementation of this Surgical Clinical Correlates in Anatomy program fulfills this need.

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

PubMed

Emerson, Roberta J; Records, Kathie

2007-01-01

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

Shoulder Arthroscopy Simulator Training Improves Shoulder Arthroscopy Performance in a Cadaver Model

PubMed Central

Henn, R. Frank; Shah, Neel; Warner, Jon J.P.; Gomoll, Andreas H.

2013-01-01

Purpose The purpose of this study was to quantify the benefits of shoulder arthroscopy simulator training with a cadaver model of shoulder arthroscopy. Methods Seventeen first year medical students with no prior experience in shoulder arthroscopy were enrolled and completed this study. Each subject completed a baseline proctored arthroscopy on a cadaveric shoulder, which included controlling the camera and completing a standard series of tasks using the probe. The subjects were randomized, and nine of the subjects received training on a virtual reality simulator for shoulder arthroscopy. All subjects then repeated the same cadaveric arthroscopy. The arthroscopic videos were analyzed in a blinded fashion for time to task completion and subjective assessment of technical performance. The two groups were compared with students t-tests, and change over time within groups was analyzed with paired t-tests. Results There were no observed differences between the two groups on the baseline evaluation. The simulator group improved significantly from baseline with respect to time to completion and subjective performance (p<0.05). Time to completion was significantly faster in the simulator group compared to controls at final evaluation (p<0.05). No difference was observed between the groups on the subjective scores at final evaluation (p=0.98). Conclusions Shoulder arthroscopy simulator training resulted in significant benefits in clinical shoulder arthroscopy time to task completion in this cadaver model. This study provides important additional evidence of the benefit of simulators in orthopaedic surgical training. Clinical Relevance There may be a role for simulator training in shoulder arthroscopy education. PMID:23591380

Association of community-based dental education components with fourth-year dental students' clinical performance.

PubMed

Major, Nicole; McQuistan, Michelle R; Qian, Fang

2014-08-01

The purpose of this study was to assess which components of a community-based dental education (CBDE) program at The University of Iowa College of Dentistry & Dental Clinics were associated with overall student performance. This retrospective study analyzed data for 444 fourth-year students who graduated in 2006 through 2011. Information pertaining to students' CBDE rotations and their final grades from the comprehensive clinic (in two areas: Production and Competence) were used for statistical analysis. Bivariate analyses indicated that students who completed CBDE in the fall were more likely to receive an A or B in Production compared to students who completed CBDE in the spring. However, students who completed CBDE in the beginning or end of the academic year were more likely to receive an A or B in Competence compared to those who completed CBDE in the middle of the year. Students who treated a variety of patient types during CBDE experiences (comprehensive and emergency care vs. mainly comprehensive care) were more likely to receive better grades in Production, while CBDE clinic type was not associated with grades. Dental schools should consider how CBDE may impact students' performance in their institutional clinics when developing and evaluating CBDE programs.

Adult Co-morbidity Evaluation 27 scores of head and neck cancer patients using touch-screen technology: patient satisfaction and clinical verification.

PubMed

Brammer, C; Dawson, D; Joseph, M; Tipper, J; Jemmet, T; Liew, L; Spinou, C; Grew, N; Pigadas, N; Rehman, K

2017-05-01

This study aimed to assess head and neck cancer patient satisfaction with the use of a touch-screen computer patient-completed questionnaire for assessing Adult Co-morbidity Evaluation 27 co-morbidity scores prior to treatment, along with its clinical reliability. A total of 96 head and neck cancer patients were included in the audit. An accurate Adult Co-morbidity Evaluation 27 co-morbidity score was achieved via patient-completed questionnaire assessment for 97 per cent of participants. In all, 96 per cent of patients found the use of a touch-screen computer acceptable and would be willing to use one again, and 62 per cent would be willing to do so without help. Patients were more likely to be willing to use the computer again without help if they were aged 65 years or younger (χ2 test; p = 0.0054) or had a performance status of 0 or 1 (χ2 test; p = 0.00034). Use of a touch-screen computer is an acceptable approach for assessing Adult Co-morbidity Evaluation 27 scores at pre-treatment assessment in a multidisciplinary joint surgical-oncology clinic.

Group intervention for burnout in parents of chronically ill children - a small-scale study.

PubMed

Lindström, Caisa; Åman, Jan; Anderzén-Carlsson, Agneta; Lindahl Norberg, Annika

2016-12-01

Long-term stress leading to burnout symptoms is prevalent in parents of chronically ill children. The aim of the study was to evaluate the effect of a group intervention by measuring changes in self-rated clinical burnout and performance-based self-esteem. In addition, the parental perceptions of the acceptability of the intervention were explored. Previously, we have explored the prevalence of clinical burnout in parents of patients 1-18 years with type 1 diabetes mellitus (T1DM) and inflammatory bowel disease (IBD) in the county of Örebro. All parents who exhibited clinical burnout symptoms in accordance with the Shirom-Melamed Burnout Questionnaire (SMBQ) were then invited to participate in a group intervention, which was evaluated in the present small-scale study. The group intervention consisted of eight sessions over a 12-week period, including education about behaviour, cognition and symptoms associated with burnout, intending to help the parents to develop adequate strategies for coping with and reducing stress. We evaluated the effect of the intervention in terms of self-rated clinical burnout and performance-based self-esteem (PBSE). In addition, the acceptability of the intervention was evaluated by analyses of recruitment and retention and self-reports from parents. Sixteen parents (13 of children with TIDM and three of children with IBD) out of 104 reporting clinical burnout participated in the intervention. All participants completed the intervention, and the mean attendance rate at all sessions was 90%. Parents' subjective evaluations were mainly positive, and SMBQ (p = 0.01) and PBSE scale (p = 0.04) measurements were significantly reduced, which effects remained 6 months after completion of the intervention. Despite the small-scale study, we consider that this intervention for parents with clinical burnout was appreciated and well accepted. The significant reduction in clinical burnout symptoms requires further evaluation in randomised controlled studies based on larger groups of parents. © 2015 Nordic College of Caring Science.

Using clinical journaling to capture critical thinking across the curriculum.

PubMed

Ruthman, Jacklyn; Jackson, Janet; Cluskey, Maureen; Flannigan, Peggy; Folse, Victoria N; Bunten, Jo

2004-01-01

Clinical journaling is used as an integrated teaching methodology throughout the practicum component of a baccalaureate nursing curriculum. Two disciplines, Nursing and English, collaborated to develop clinical journaling guidelines to provide a consistent framework for student learning and evaluation in a variety of clinical settings. Students complete a weekly log for each clinical rotation. They identify learning goals, analyze events and relate them to nursing practice, use critical thinking to connect theory and practice, and reflect on the experience.A collegiate standard of writing is used. As the student advances through the program, a pattern of accomplishments and a cumulative integration of skills is evidenced to provide consistent standards for student evaluation.

Is it the time to rethink clinical decision-making strategies? From a single clinical outcome evaluation to a Clinical Multi-criteria Decision Assessment (CMDA).

PubMed

Migliore, Alberto; Integlia, Davide; Bizzi, Emanuele; Piaggio, Tomaso

2015-10-01

There are plenty of different clinical, organizational and economic parameters to consider in order having a complete assessment of the total impact of a pharmaceutical treatment. In the attempt to follow, a holistic approach aimed to provide an evaluation embracing all clinical parameters in order to choose the best treatments, it is necessary to compare and weight multiple criteria. Therefore, a change is required: we need to move from a decision-making context based on the assessment of one single criteria towards a transparent and systematic framework enabling decision makers to assess all relevant parameters simultaneously in order to choose the best treatment to use. In order to apply the MCDA methodology to clinical decision making the best pharmaceutical treatment (or medical devices) to use to treat a specific pathology, we suggest a specific application of the Multiple Criteria Decision Analysis for the purpose, like a Clinical Multi-criteria Decision Assessment CMDA. In CMDA, results from both meta-analysis and observational studies are used by a clinical consensus after attributing weights to specific domains and related parameters. The decision will result from a related comparison of all consequences (i.e., efficacy, safety, adherence, administration route) existing behind the choice to use a specific pharmacological treatment. The match will yield a score (in absolute value) that link each parameter with a specific intervention, and then a final score for each treatment. The higher is the final score; the most appropriate is the intervention to treat disease considering all criteria (domain an parameters). The results will allow the physician to evaluate the best clinical treatment for his patients considering at the same time all relevant criteria such as clinical effectiveness for all parameters and administration route. The use of CMDA model will yield a clear and complete indication of the best pharmaceutical treatment to use for patients, helping physicians to choose drugs with a complete set of information, imputed in the model. Copyright © 2015 Elsevier Ltd. All rights reserved.

ADCS Prevention Instrument Project: assessment of instrumental activities of daily living for community-dwelling elderly individuals in dementia prevention clinical trials.

PubMed

Galasko, Douglas; Bennett, David A; Sano, Mary; Marson, Daniel; Kaye, Jeff; Edland, Steven D

2006-01-01

In primary prevention trials for Alzheimer disease, the inception cohort typically has normal or minimally impaired complex activities of daily living (ADL). ADL change during a trial could trigger detailed evaluation or serve as an outcome measure. A brief, easily administered, and reliable ADL rating scale would assist prevention studies. To develop an ADL scale for prevention trials that allows self-rating or completion by informants. The Activities of Daily Living-Prevention Instrument (ADL-PI) was developed, comprising 15 ADL and 5 physical function questions. Six hundred forty-four elderly subjects participating in the Prevention Instrument Project completed a self-rated version of the ADL-PI, and informants for 632 subjects completed an informant version. Informants also completed a Mild Cognitive Impairment (MCI) ADL questionnaire to allow comparisons. Subjects performed well on all ADL scales at baseline. Completion of the ADL-PI questionnaires at home or in-clinic yielded comparable information. Scores from baseline to 3 months had good reliability. The ADL-PI, obtained from either self-report or informants, discriminated between subjects rated as CDR 0 and CDR 0.5. Subjects with worse baseline cognitive performance also had slightly worse ADL-PI scores. Preliminary analysis indicates that subjects who triggered cognitive evaluations had slightly lower baseline ADL-PI scores by both self and informant reports. The ADL-PI can be completed at home or in clinic, and has adequate reliability. The utility of self-administered and informant versions and predictive value of reported deficits requires further follow-up.

Neuromuscular findings in thyroid dysfunction: a prospective clinical and electrodiagnostic study.

PubMed

Duyff, R F; Van den Bosch, J; Laman, D M; van Loon, B J; Linssen, W H

2000-06-01

To evaluate neuromuscular signs and symptoms in patients with newly diagnosed hypothyroidism and hyperthyroidism. A prospective cohort study was performed in adult patients with newly diagnosed thyroid dysfunction. Patients were evaluated clinically with hand held dynamometry and with electrodiagnosis. The clinical features of weakness and sensory signs and the biochemical data were evaluated during treatment. In hypothyroid patients 79% had neuromuscular complaints, 38% had clinical weakness (manual muscle strength testing) in one or more muscle groups, 42% had signs of sensorimotor axonal neuropathy, and 29% had carpal tunnel syndrome. Serum creatine kinase did not correlate with weakness. After 1 year of treatment 13% of the patients still had weakness. In hyperthyroid patients 67% had neuromuscular symptoms, 62% had clinical weakness in at least one muscle group that correlated with FT4 concentrations, but not with serum CK. Nineteen per cent of the patients had sensory-motor axonal neuropathy and 0% had carpal tunnel syndrome. The neuromuscular signs developed rapidly, early in the course of the disorder and were severe, but resolved rapidly and completely during treatment (average time 3.6 months). Neuromuscular symptoms and signs were present in most patients. About 40% of the hypothyroid patients and 20% of the hyperthyroid patients had predominantly sensory signs of a sensorimotor axonal neuropathy early in the course of thyroid disease. Weakness in hyperthyroidism evolved rapidly at an early stage of the disorder and resolved completely during treatment, suggesting a functional muscle disorder. Hand held dynamometry is sensitive for the detection of weakness and for the clinical evaluation of treatment effects. Weakness in hypothyroidism is more difficult to treat, suggesting myopathy.

Complete mucosal healing of distal lesions induced by twice-daily budesonide 2-mg foam promoted clinical remission of mild-to-moderate ulcerative colitis with distal active inflammation: double-blind, randomized study.

PubMed

Naganuma, Makoto; Aoyama, Nobuo; Tada, Tomohiro; Kobayashi, Kiyonori; Hirai, Fumihito; Watanabe, Kenji; Watanabe, Mamoru; Hibi, Toshifumi

2018-04-01

Budesonide foam is used for the topical treatment of distal ulcerative colitis. This phase III study was performed to confirm mucosal healing and other therapeutic effects of twice-daily budesonide 2-mg foam in patients with mild-to-moderate ulcerative colitis including left-sided colitis and pancolitis. This was a multicenter, randomized, placebo-controlled, double-blind trial. A total of 126 patients with mild-to-moderate ulcerative colitis with active inflammation in the distal colon were randomized to two groups receiving twice-daily budesonide 2 mg/25 ml foam or placebo foam. The primary endpoint was the percentage of complete mucosal healing of distal lesions (endoscopic subscore of 0) at week 6. Some patients continued the treatment through week 12. Drug efficacy and safety were evaluated. The percentages of both complete mucosal healing of distal lesions and clinical remission were significantly improved in the budesonide as compared with the placebo group (p = 0.0003 and p = 0.0035). Subgroup analysis showed similar efficacy of budesonide foam for complete mucosal healing of distal lesions and clinical remission regardless of disease type. The clinical remission percentage tended to be higher in patients achieving complete mucosal healing of distal lesions than in other patients. There were no safety concerns with budesonide foam. This study confirmed for the first time complete mucosal healing with twice-daily budesonide 2-mg foam in mild-to-moderate ulcerative colitis with distal active inflammation. The results also indicated that complete mucosal healing of distal lesions by budesonide foam promotes clinical remission of ulcerative colitis. Clinical trial registration no.: Japic CTI-142704.

A new method for the assessment of patient safety competencies during a medical school clerkship using an objective structured clinical examination

PubMed Central

Daud-Gallotti, Renata Mahfuz; Morinaga, Christian Valle; Arlindo-Rodrigues, Marcelo; Velasco, Irineu Tadeu; Arruda Martins, Milton; Tiberio, Iolanda Calvo

2011-01-01

INTRODUCTION: Patient safety is seldom assessed using objective evaluations during undergraduate medical education. OBJECTIVE: To evaluate the performance of fifth-year medical students using an objective structured clinical examination focused on patient safety after implementation of an interactive program based on adverse events recognition and disclosure. METHODS: In 2007, a patient safety program was implemented in the internal medicine clerkship of our hospital. The program focused on human error theory, epidemiology of incidents, adverse events, and disclosure. Upon completion of the program, students completed an objective structured clinical examination with five stations and standardized patients. One station focused on patient safety issues, including medical error recognition/disclosure, the patient-physician relationship and humanism issues. A standardized checklist was completed by each standardized patient to assess the performance of each student. The student's global performance at each station and performance in the domains of medical error, the patient-physician relationship and humanism were determined. The correlations between the student performances in these three domains were calculated. RESULTS: A total of 95 students participated in the objective structured clinical examination. The mean global score at the patient safety station was 87.59±1.24 points. Students' performance in the medical error domain was significantly lower than their performance on patient-physician relationship and humanistic issues. Less than 60% of students (n = 54) offered the simulated patient an apology after a medical error occurred. A significant correlation was found between scores obtained in the medical error domains and scores related to both the patient-physician relationship and humanistic domains. CONCLUSIONS: An objective structured clinical examination is a useful tool to evaluate patient safety competencies during the medical student clerkship. PMID:21876976

Assessment of Allergy to Milk, Egg, Cod, and Wheat in Swedish Schoolchildren: A Population Based Cohort Study.

PubMed

Winberg, Anna; West, Christina E; Strinnholm, Åsa; Nordström, Lisbeth; Hedman, Linnea; Rönmark, Eva

2015-01-01

Knowledge about the prevalence of allergies to foods in childhood and adolescence is incomplete. The purpose of this study was to investigate the prevalence of allergies to milk, egg, cod, and wheat using reported data, clinical examinations, and double-blind placebo-controlled food challenges, and to describe the phenotypes of reported food hypersensitivity in a cohort of Swedish schoolchildren. In a population-based cohort of 12-year-old children, the parents of 2612 (96% of invited) completed a questionnaire. Specific IgE antibodies to foods were analyzed in a random sample (n=695). Children reporting complete avoidance of milk, egg, cod, or wheat due to perceived hypersensitivity and without physician-diagnosed celiac disease were invited to undergo clinical examination that included specific IgE testing, a celiac screening test, and categorization into phenotypes of food hypersensitivity according to preset criteria. Children with possible food allergy were further evaluated with double-blind challenges. In this cohort, the prevalence of reported food allergy to milk, egg, cod, or wheat was 4.8%. Food allergy was diagnosed in 1.4% of the children after clinical evaluation and in 0.6% following double-blind placebo-controlled food challenge. After clinical examination, children who completely avoided one or more essential foods due to perceived food hypersensitivity were categorized with the following phenotypes: allergy (29%), outgrown allergy (19%), lactose intolerance (40%), and unclear (12%). There was a high discrepancy in the prevalence of allergy to milk, egg, cod and wheat as assessed by reported data, clinical evaluation, and double-blind food challenges. Food hypersensitivity phenotyping according to preset criteria was helpful for identifying children with food allergy.

Assessment of Allergy to Milk, Egg, Cod, and Wheat in Swedish Schoolchildren: A Population Based Cohort Study

PubMed Central

Winberg, Anna; West, Christina E; Strinnholm, Åsa; Nordström, Lisbeth; Hedman, Linnea; Rönmark, Eva

2015-01-01

Objectives Knowledge about the prevalence of allergies to foods in childhood and adolescence is incomplete. The purpose of this study was to investigate the prevalence of allergies to milk, egg, cod, and wheat using reported data, clinical examinations, and double-blind placebo-controlled food challenges, and to describe the phenotypes of reported food hypersensitivity in a cohort of Swedish schoolchildren. Methods In a population-based cohort of 12-year-old children, the parents of 2612 (96% of invited) completed a questionnaire. Specific IgE antibodies to foods were analyzed in a random sample (n=695). Children reporting complete avoidance of milk, egg, cod, or wheat due to perceived hypersensitivity and without physician-diagnosed celiac disease were invited to undergo clinical examination that included specific IgE testing, a celiac screening test, and categorization into phenotypes of food hypersensitivity according to preset criteria. Children with possible food allergy were further evaluated with double-blind challenges. Results In this cohort, the prevalence of reported food allergy to milk, egg, cod, or wheat was 4.8%. Food allergy was diagnosed in 1.4% of the children after clinical evaluation and in 0.6% following double-blind placebo-controlled food challenge. After clinical examination, children who completely avoided one or more essential foods due to perceived food hypersensitivity were categorized with the following phenotypes: allergy (29%), outgrown allergy (19%), lactose intolerance (40%), and unclear (12%). Conclusions There was a high discrepancy in the prevalence of allergy to milk, egg, cod and wheat as assessed by reported data, clinical evaluation, and double-blind food challenges. Food hypersensitivity phenotyping according to preset criteria was helpful for identifying children with food allergy. PMID:26134827

Supporting student mental health nurses in clinical placement through virtual in-practice support (VIPS): Innovation uptake and the 'VIPS' project.

PubMed

Hardy, Sally; Mushore, Manyara; Goddard, Linda

2016-11-01

The integration of technology in nurse education has become an essential element of academic practice. Yet innovation uptake between academic institutions across the four countries of the UK and their clinical practice partners has proved problematic, leading to a slow introduction of digitally enhanced teaching and learning innovations, particularly in the area of clinical decision making and leadership. The Virtual in Practice Support (VIPS) project involved two academic institutions working with the same mental health care service partner aiming to maximise student clinical placement learning. Student nurses in their final year of training were invited to take part in testing the viability of distance e-tutoring (via computer access to academic nurse lecturers) for facilitated critical reflection. An evaluation of the use of video linked conference sessions, set up for students to undertake a group based online (i.e. virtual) group tutorial is presented. All participants completed an evaluation data sheet using a five point Likert scale and free text evaluation feedback form completed at the end of each online tutorial session. Students were also invited to a focus group and all tutors were interviewed at the completion of the project. The VIPS project findings highlight; i) the importance of a clear project vision for innovation uptake ii) consequences of working with innovation champions and iii) how technology can be used to maximise student learning across geographical distance through online facilitated group critical discussion. VIPS' participants were able to articulate positive outcomes as a result of engaging in a multi-institutional project that capitalised on the richness of nursing clinical practice learning experience for both the students and the academics involved as innovation champions. Copyright © 2016 Elsevier Ltd. All rights reserved.

[Implementation of a remote oncology-monitoring program for cancer patients in outpatient care unit: A major challenge for the different actors].

PubMed

Peyrilles, Elodie; Lepage-Seydoux, Coralie; Sejean, Karine; Bonan, Brigitte

2018-04-01

The development of outpatient departments requires health professionals to reorganize practices for a better patient monitoring and a better patient care pathway. To evaluate, using indicators, the impact of an oncology-monitoring program on activity and organizational fluidity in a Cytotoxic Preparation Unit and clinical departments. Method the clinical and biological data are collected between two injections by calling the patient two days prior chemotherapy is performed by a specialist nurse of an outsourced medical call center. After medical and pharmaceutical validation, early preparations (D-1) for expensive and non-expensive molecules are performed. The program is started in February 2016. After 3 months, 382 patients were included into the program. Twenty-three patients on average are called per day related to 1162 completed clinical questionnaires (87%). Among the files, 47% are complete at D-2 (biological and clinical data). The early preparation rate of expensive drugs, zero before the program for financial reasons, has reached 40% at 3 months. The destroyed preparation rate because of non-administration decreased from 5 to 2%. Preliminary results show a significant patient compliance, feasibility of early preparation of expensive and non-expensive chemotherapy. These are preliminary results of a one-year study. They will be completed by an evaluation of patients' and health professionals' satisfaction, evaluation of length of stay, optimization of operations for clinical departments and CPU. The D-2 biological data collection must be improved. A strong doctor/pharmacist collaboration is essential for better patient care pathway. Copyright © 2018 Société Française du Cancer. Published by Elsevier Masson SAS. All rights reserved.

On individual differences in person perception: raters' personality traits relate to their psychopathy checklist-revised scoring tendencies.

PubMed

Miller, Audrey K; Rufino, Katrina A; Boccaccini, Marcus T; Jackson, Rebecca L; Murrie, Daniel C

2011-06-01

This study investigated raters' personality traits in relation to scores they assigned to offenders using the Psychopathy Checklist-Revised (PCL-R). A total of 22 participants, including graduate students and faculty members in clinical psychology programs, completed a PCL-R training session, independently scored four criminal offenders using the PCL-R, and completed a comprehensive measure of their own personality traits. A priori hypotheses specified that raters' personality traits, and their similarity to psychopathy characteristics, would relate to raters' PCL-R scoring tendencies. As hypothesized, some raters assigned consistently higher scores on the PCL-R than others, especially on PCL-R Facets 1 and 2. Also as hypothesized, raters' scoring tendencies related to their own personality traits (e.g., higher rater Agreeableness was associated with lower PCL-R Interpersonal facet scoring). Overall, findings underscore the need for future research to examine the role of evaluator characteristics on evaluation results and the need for clinical training to address evaluators' personality influences on their ostensibly objective evaluations.

Evaluation of a multimodal, distance learning HIV management course for clinical care providers in India.

PubMed

Chang, Larry William; Kadam, Dileep B; Sangle, Shashi; Narayanan, Shivakumar; Borse, Rohidas T; McKenzie-White, Jane; Bowen, Craig W; Sisson, Stephen D; Bollinger, Robert C

2012-01-01

Distance learning is an important tool for training HIV health workers. However, there is limited evidence on design and evaluation of distance learning HIV curricula and tools. We therefore designed, implemented, and evaluated a distance learning course on HIV management for clinical care providers in India. After course completion, participant scores rose significantly from a pretest (78.4% mean correct) compared with the posttest (87.5%, P < .001). After course completion, participants were more likely to be confident in starting an initial antiretroviral (ARV) regimen, understanding ARV toxicities, encouraging patient adherence, diagnosing immune reconstitution syndrome, and monitoring patients on ARV medications (P ≤ .05). All participants (100%) strongly agreed/agreed that they would recommend this course to others, and most of them (96%) strongly agreed/agreed that they would take a course in this format again. A pragmatic approach to HIV curriculum development and evaluation resulted in reliable learning outcomes, as well as learner satisfaction and improvement in knowledge.

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

PubMed

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

2007-12-01

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

Multicenter clinical trial of a home-use nonablative fractional laser device for wrinkle reduction.

PubMed

Leyden, James; Stephens, Thomas J; Herndon, James H

2012-11-01

Until now, nonablative fractional treatments could only be delivered in an office setting by trained professionals. The goal of this work was to perform clinical testing of a nonablative fractional laser device designed for home-use. This multicenter trial consisted of two clinical studies with slightly varying treatment protocols in which subjects performed at-home treatments of periorbital wrinkles using a handheld nonablative fractional laser. Both studies included an active treatment phase (daily treatments) and a maintenance phase (twice-weekly treatments). In all, 36 subjects were followed up for as long as 5 months after completion of the maintenance phase and 90 subjects were followed up until the completion of the maintenance phase. Evaluations included in-person investigator assessment, independent blinded review of high-resolution images using the Fitzpatrick Wrinkle Scale, and subject self-assessment. All 124 subjects who completed the study were able to use the device following written instructions for use. Treatments were well tolerated with good protocol compliance. Independent blinded evaluations by a panel of physicians showed Fitzpatrick Wrinkle Scale score improvement by one or more grades in 90% of subjects at the completion of the active phase and in 79% of subjects at the completion of the maintenance phase. The most prevalent side effect was transient posttreatment erythema. Lack of a control group and single-blinded study groups were limitations. Safety testing with self-applications by users demonstrated the utility of the device for home use. Independent blinded review of clinical images confirmed the device's proficiency for improving periorbital wrinkles. Copyright © 2012 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.

Outcomes of annual wellness visits provided by pharmacists in an accountable care organization associated with a federally qualified health center.

PubMed

Alhossan, Abdulaziz; Kennedy, Amy; Leal, Sandra

2016-02-15

The clinical and financial outcomes of annual wellness visits (AWVs) conducted by clinical pharmacists working as part of an accountable care organization (ACO) in a federally qualified health center were evaluated. In this retrospective, single-center, chart review study, patients seen for AWVs at El Rio Health Center between October and December 2013 were eligible for study inclusion. Data collected from patient charts included patient demographics, preventive screenings ordered by clinical pharmacists during the AWV and completed within one month after the visit, other screenings completed by clinical pharmacists during the visit, medication changes by clinical pharmacists, and revenues collected from the AWV and preventive screenings. Descriptive statistics were calculated and variables compared; p values were calculated using single-sample Student's t tests. Three hundred patient records were reviewed. Clinical pharmacists completed 1608 interventions, with a mean of 5.4 interventions per patient. A total of 272 referrals were made, 120 (45%) of which were completed within one month of the visit. Of the 183 laboratory tests ordered for diabetes and lipid screening, 152 (83%) were completed within one month of the AWV (p < 0.001). Of the 370 vaccinations offered during the visits, 182 (49%) were administered (p < 0.001). Twenty-four medication and dosage changes were made by clinical pharmacists during AWVs, and the total revenue for the AWVs conducted by pharmacists and services completed during the visits exceeded $22,000. Recommendations made by pharmacists during AWVs in an ACO associated with a federally qualified health center had a high acceptance rate and generated substantial revenue. Copyright © 2016 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Development and implementation of a competency-based clinical evaluation tool for midwifery education.

PubMed

Woeber, Kate

2018-07-01

The learning goals and evaluation strategies of competency-based midwifery programs must be explicit and well-defined. In the US, didactic learning is evaluated through a standardized certification examination, but standardized clinical competence evaluation is lacking. The Midwifery Competency Assessment Tool (MCAT) has been adapted from the International Confederation of Midwives' (ICM) "Essential Competencies" and from the American College of Nurse-Midwives' (ACNM) "Core Competencies", with student self-evaluation based on Benner's Novice-to-Expert theory. The MCAT allows for the measurement and monitoring of competence development in all domains of full-scope practice over the course of the midwifery program. Strengths of the MCAT are that it provides clear learning goals and performance evaluations for students, ensures and communicates content mapping across a curriculum, and highlights strengths and gaps in clinical opportunities at individual clinical sites and for entire programs. Challenges of the MCAT lie in balancing the number of competency items to be measured with the tedium of form completion, in ensuring the accuracy of student self-evaluation, and in determining "adequate" competence achievement when particular clinical opportunities are limited. Use of the MCAT with competency-based clinical education may facilitate a more standardized approach to clinical evaluation, as well as a more strategic approach to clinical site development and use. Copyright © 2018 Elsevier Ltd. All rights reserved.

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

PubMed

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

2015-08-01

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

Patient-Reported Barriers to the Prekidney Transplant Evaluation in an At-Risk Population in the United States.

PubMed

Lockwood, Mark B; Saunders, Milda R; Nass, Rachel; McGivern, Claire L; Cunningham, Patrick N; Chon, W James; Josephson, Michelle A; Becker, Yolanda T; Lee, Christopher S

2017-06-01

Despite our knowledge of barriers to the early stages of the transplant process, we have limited insight into patient-reported barriers to the prekidney transplant medical evaluation in populations largely at-risk for evaluation failure. One-hundred consecutive adults were enrolled at an urban, Midwestern transplant center. Demographic, clinical, and quality of life data were collected prior to patients visit with a transplant surgeon/nephrologist (evaluation begins). Patient-reported barriers to evaluation completion were collected using the Subjective Barriers Questionnaire 90-days after the initial medical evaluation appointment (evaluation ends), our center targeted goal for transplant work-up completion. At 90 days, 40% of participants had not completed the transplant evaluation. Five barrier categories were created from the 85 responses to the Subjective Barriers Questionnaire. Patient-reported barriers included poor communication, physical health, socioeconomics, psychosocial influences, and access to care. In addition, determinants for successful evaluation completion included being of white race, higher income, free of dialysis, a lower comorbid burden, and reporting higher scores on the Kidney Disease Quality of Life subscale role-emotional. Poor communication between patients and providers, and among providers, was the most prominent patient-reported barrier identified. Barriers were more prominent in marginalized groups such as ethnic minorities and people with low income. Understanding the prevalence of patient-reported barriers may aid in the development of patient-centered interventions to improve completion rates.

Preliminary results of a phase I/II clinical trial using in situ photoimmunotherapy combined with imiquimod for metastatic melanoma patients

NASA Astrophysics Data System (ADS)

Li, Xiaosong; Naylor, Mark F.; Nordquist, Robert E.; Teague, T. Kent; Howard, C. Anthony; Murray, Cynthia; Chen, Wei R.

2010-02-01

In Situ Photoimmunotherapy (ISPI), a newly developed modality for cancer therapy, has been shown to be able to modulate the body's own immune response. This clinical trial was designed to evaluate the safety and therapeutic effect of ISPI, using imiquimod as its immunoadjuvant for metastatic melanoma patients. ISPI consisted of three main components applied directly to the cutaneous metastases: 1) local application of topical imiquimod; 2) injection of indocyanine green; and 3) an 805 nm laser for local irradiation. All patients completed at least one cycle of treatment. All the patients completed at least one cycle of treatments; one patient received 6 cycles. The most common adverse effects were rash, pruritus, pain, fatigue and anorexia. Fever, chills, vomiting and cellulitis were relative rare. No grade 4 toxicity was observed. Complete Response (CR) was observed in 6 patients. Median overall survival of the 11 evaluated patients was 12.2 months. Six of the eleven patients were still alive at the time of this report. Treatment of ISPI using imiquimod is safe and well tolerant. Our preliminary clinical results suggest that this new method can be a promising modality for metastatic melanoma.

The clinical reasoning process in randomized clinical trials with patients with non-specific neck pain is incomplete: A systematic review.

PubMed

Maissan, Francois; Pool, Jan; de Raaij, Edwin; Mollema, Jürgen; Ostelo, Raymond; Wittink, Harriet

2018-06-01

Primarily to evaluate the completeness of the description of the clinical reasoning process in RCTs with patients with non-specific neck pain with an argued or diagnosed cause i.e. an impairment or activity limitation. Secondly, to determine the association between the completeness of the clinical reasoning process and the degree of risk of bias. Pubmed, Cinahl and PEDro were systematically searched from inception to July 2016. RCTs (n = 122) with patients with non-specific neck pain receiving physiotherapy treatment published in English were included. Data extraction included study characteristics and important features of the clinical reasoning process based on the Hypothesis-Oriented Algorithm for Clinicians II (HOAC II)]. Thirty-seven studies (30%) had a complete clinical reasoning process of which 8 (6%) had a 'diagnosed cause' and 29 (24%) had an 'argued cause'. The Spearmans rho association between the extent of the clinical reasoning process and the risk of bias was -0.2. In the majority of studies (70%) the described clinical reasoning process was incomplete. A very small proportion (6%) had a 'diagnosed cause'. Therefore, a better methodological quality does not necessarily imply a better described clinical reasoning process. Copyright © 2018 Elsevier Ltd. All rights reserved.

Clinical Evaluation of the Self-Injurious Behavior Inhibiting System (SIBIS).

ERIC Educational Resources Information Center

Linscheid, Thomas R.; And Others

1990-01-01

The Self-Injurious Behavior Inhibiting System (in which mild and brief contingent electric stimulation is delivered) was evaluated with five cases involving severe mental retardation and previously unmanageable self-injurious behavior. Findings indicated almost complete elimination of the self-injurious behavior with followup suggesting continuing…

Evaluating the effect of distractions in the operating room on clinical decision-making and patient safety.

PubMed

Murji, Ally; Luketic, Lea; Sobel, Mara L; Kulasegaram, Kulamakan Mahan; Leyland, Nicholas; Posner, Glenn

2016-10-01

Answering telephone calls and pagers is common distraction in the operating room. We sought to evaluate the impact of distractions on patient care by (1) assessing the accuracy and safety of responses to clinical questions posed to a surgeon while operating and (2) determining whether pager distractions affect simulation-based surgical performance. We conducted a randomized crossover study of obstetrics and gynecology residents. After studying a patient sign-out list, subjects performed a virtual salpingectomy. They were randomized to a distraction phase followed by quiet phase or vice versa. In the distraction phase, a pager beeped and subjects were asked questions based on the sign-out list. Accuracy of responses and the number of unsafe responses were recorded. In the quiet phase, trainees performed the task uninterrupted. Measures of surgical performance were successful task completion, time to task completion and operative blood loss. The mean score for correct responses to clinical questions during the distracted phase was 80 % (SD ±14 %). Nineteen residents (63 %) made at least 1 unsafe clinical decision while operating on the simulator (range 0-3). Subjects were more likely to successfully complete the surgical task in the allotted time under the quiet compared to distraction condition (OR 11.3, p = 0.03). There was no difference between the conditions in paired analysis for mean time (seconds) to task completion [426 (SD 133) vs. 440 (SD 186), p = 0.61] and mean operative blood loss (mL) [73.14 (SD 106) vs. 112.70 (SD 358), p = 0.47]. Distractions in the operating room may have a profound impact on patient safety on the wards. While multitasking in a simulated setting, the majority of residents made at least one unsafe clinical decision. Pager distractions also hindered surgical residents' ability to complete a simulated laparoscopic task in the allotted time without affecting other variables of surgical performance.

Evaluating 5 years' NIMART mentoring in South Africa's HIV treatment programme: Successes, challenges and future needs.

PubMed

Jones, M; Cameron, D

2017-09-22

Task shifting has enabled South Africa (SA) to rapidly expand its HIV treatment programme. This has been achieved by training and mentoring primary-care nurses in nurse initiation and management of antiretroviral therapy (NIMART). Five years into its clinical mentoring programme, the Foundation for Professional Development conducted an evaluation that identified improved knowledge, attitudes and confidence perceived by nurses who received NIMART mentoring. Low completion rates for the Department of Health (DoH) NIMART training process were identified and therefore targeted mentoring was introduced; this increased the percentage of primary nurses eligible for DoH certificates of clinical competence in NIMART from 12%, adding a further 30%. There remain a large number of primary nurses who require mentoring in order to complete the NIMART process. For those who have completed the process, there remains a need for ongoing mentoring as SA's HIV programme evolves, complex cases emerge and primary care undergoes change.

The Body Image Concern Inventory: validation in a multiethnic sample and initial development of a Spanish language version.

PubMed

Littleton, Heather; Breitkopf, Carmen Radecki

2008-12-01

Dysmorphic appearance concern encompasses preoccupation with a perceived appearance defect, defect checking and camouflaging, and social avoidance. The current study sought to evaluate the internal consistency, factor structure, and convergent validity of a measure of dysmorphic appearance concern, the Body Image Concern Inventory, as well as evaluate the psychometric properties of a Spanish version of the instrument. Women recruited as part of a reproductive clinic-based clinical trial completed the BICI and other self-report measures of distress. A total of 1043 women completed the measures in English (M=29 years, range=18-55 years) and 573 women completed the measures in Spanish (M=32 years, range=18-55 years). Both the English and Spanish BICI were internally consistent and correlated moderately with measures of current psychological distress (STAI-S, CES-D). Confirmatory factor analyses replicated the measure's proposed factor structure. Applications of the BICI for future research are discussed.

Utilization of a patient-centered asthma passport tool in a subspecialty clinic

PubMed Central

Greenberg, Jonathan; Prushinskaya, Olga; Harris, Joshua D.; Guidetti-Myers, Giltian; Steiding, Jacqueline; Sawicki, Gregory S.; Gaffin, Jonathan M.

2018-01-01

Introduction Despite available and effective tools for asthma self-assessment (Asthma Control Test, ACT) and self-management (Asthma Action Plan, AAP), they are underutilized in outpatient specialty clinics. We evaluated the impact of a patient-centered checklist, the Asthma Passport, on improving ACT and AAP utilization in clinic. Methods This was a randomized, interventional quality-improvement project in which the Asthma Passport was distributed to 120 pediatric asthma patients over the duration of 16 weeks. The passport’s checklist consisted of tasks to be completed by the patient/family, including completion of the ACT and AAP. We compared rates of completion of the ACT and AAP for those who received the passport versus the control group, and assessed patient/caregiver and provider satisfaction. Results Based on electronic medical record data from 222 participants, the ACT completion rate was not significantly different between the passport and control groups, however, the AAP completion rate was significantly greater than control (30.0% vs. 17.7%, p = 0.04). When per-protocol analysis was limited to groups who completed and returned their passports, ACT and AAP completion rates were significantly greater than control (73.8% vs. 44.1% (p = 0.002) and 35.7% vs. 17.7% (p = 0.04), respectively). Nearly all participants reported high satisfaction with care, and surveyed providers viewed the passport favorably. Conclusions A patient-centered checklist significantly improved the completion rate of the AAP. For patient’s who completed and returned the asthma passport, the ACT completion rate was also improved. Participants and providers reported high satisfaction with the checklist, suggesting that it can effectively promote asthma self-management and self-assessment without burdening clinicians or clinic workfiow. PMID:28548904

Utilization of a patient-centered asthma passport tool in a subspecialty clinic.

PubMed

Greenberg, Jonathan; Prushinskaya, Olga; Harris, Joshua D; Guidetti-Myers, Gillian; Steiding, Jacqueline; Sawicki, Gregory S; Gaffin, Jonathan M

2018-02-01

Despite available and effective tools for asthma self-assessment (Asthma Control Test, ACT) and self-management (Asthma Action Plan, AAP), they are underutilized in outpatient specialty clinics. We evaluated the impact of a patient-centered checklist, the Asthma Passport, on improving ACT and AAP utilization in clinic. This was a randomized, interventional quality-improvement project in which the Asthma Passport was distributed to 120 pediatric asthma patients over the duration of 16 weeks. The passport's checklist consisted of tasks to be completed by the patient/family, including completion of the ACT and AAP. We compared rates of completion of the ACT and AAP for those who received the passport versus the control group, and assessed patient/caregiver and provider satisfaction. Based on electronic medical record data from 222 participants, the ACT completion rate was not significantly different between the passport and control groups, however, the AAP completion rate was significantly greater than control (30.0% vs. 17.7%, p = 0.04). When per-protocol analysis was limited to groups who completed and returned their passports, ACT and AAP completion rates were significantly greater than control (73.8% vs. 44.1% (p = 0.002) and 35.7% vs. 17.7% (p = 0.04), respectively). Nearly all participants reported high satisfaction with care, and surveyed providers viewed the passport favorably. A patient-centered checklist significantly improved the completion rate of the AAP. For patient's who completed and returned the asthma passport, the ACT completion rate was also improved. Participants and providers reported high satisfaction with the checklist, suggesting that it can effectively promote asthma self-management and self-assessment without burdening clinicians or clinic workflow.

Self Concept of Adolescent Sexual Abuse Victims.

ERIC Educational Resources Information Center

Orr, Donald P.; Downes, Maureen C.

1985-01-01

To assess the self-concept and psychological profile associated with sexual abuse, 20 young female victims evaluated in a sexual abuse clinic completed the Offer Self-Image Questionnaire. (Author/LMO)

Choosing which practitioner sees the next patient in the preanesthesia evaluation clinic based on the relative speeds of the practitioner.

PubMed

Dexter, Franklin; Ahn, Hyun-Soo; Epstein, Richard H

2013-04-01

When a practitioner in a preanesthesia evaluation clinic is not evaluating a patient because no patient is waiting to be seen, the practitioner often has other responsibilities such as reviewing charts of patients. When practitioners differ in how quickly they complete evaluations, multiple scenarios can be created wherein the slowest practitioner would only evaluate patients when the number of patients waiting exceeds a threshold (e.g., at least 2 patients are waiting). Review of operations research studies identified conditions for which such management of the queue can be beneficial (e.g., mean evaluation time of the fastest practitioner is less than half that of the slowest practitioner). These conditions were compared with the actual completion rates of certified registered nurse practitioners at a hospital's clinic. The 99.9% confidence intervals (CI) were calculated for ratios of mean evaluation times. The fastest practitioner was typically 1.23 times faster than the second fastest practitioner (CI 1.22-1.23) and 1.61 times faster than the slowest of three practitioners (1.59-1.61). These are significantly less than the 3 times and 2 times faster, respectively, that would be sufficiently large to warrant managing queue discipline. Practitioners with longer mean evaluation times had larger percentage utilizations of working time (Kendall τb = 0.56, P = 0.0001), inconsistent with preferential assignment of patients to the fastest practitioner(s) available. Practitioners' speeds in evaluating patients do not differ sufficiently for information systems to be used routinely to choose who evaluates the next patient (i.e., state-dependent assignment policy). Clinics aiming to reduce patient waiting should focus on reducing the overall mean evaluation time (e.g., by chart review ahead), appropriately scheduling patients, and having the right numbers of nursing assistants and practitioners.

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

PubMed

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

2011-03-01

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

Neuromuscular findings in thyroid dysfunction: a prospective clinical and electrodiagnostic study

PubMed Central

Duyff, R.; Van den Bosch, J.; Laman, D; van Loon, B.-J. P.; Linssen, W.

2000-01-01

OBJECTIVES—To evaluate neuromuscular signs and symptoms in patients with newly diagnosed hypothyroidism and hyperthyroidism.
METHODS—A prospective cohort study was performed in adult patients with newly diagnosed thyroid dysfunction. Patients were evaluated clinically with hand held dynamometry and with electrodiagnosis. The clinical features of weakness and sensory signs and the biochemical data were evaluated during treatment.
RESULTS—In hypothyroid patients 79% had neuromuscular complaints, 38% had clinical weakness (manual muscle strength testing) in one or more muscle groups, 42% had signs of sensorimotor axonal neuropathy, and 29% had carpal tunnel syndrome. Serum creatine kinase did not correlate with weakness. After 1 year of treatment 13% of the patients still had weakness. In hyperthyroid patients 67% had neuromuscular symptoms, 62% had clinical weakness in at least one muscle group that correlated with FT4 concentrations, but not with serum CK. Nineteen per cent of the patients had sensory-motor axonal neuropathy and 0% had carpal tunnel syndrome. The neuromuscular signs developed rapidly, early in the course of the disorder and were severe, but resolved rapidly and completely during treatment (average time 3.6months).
CONCLUSIONS—Neuromuscular symptoms and signs were present in most patients. About 40% of the hypothyroid patients and 20% of the hyperthyroid patients had predominantly sensory signs of a sensorimotor axonal neuropathy early in the course of thyroid disease. Weakness in hyperthyroidism evolved rapidly at an early stage of the disorder and resolved completely during treatment, suggesting a functional muscle disorder. Hand held dynamometry is sensitive for the detection of weakness and for the clinical evaluation of treatment effects. Weakness in hypothyroidism is more difficult to treat, suggesting myopathy.

 PMID:10811699

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

PubMed

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

2017-06-01

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

Assessment of spontaneous resolution of idiopathic bone cavity.

PubMed

Battisti, Maíra de Paula Leite; Soares, Mariana Quirino Silveira; Rubira, Cássia Maria Fischer; Bullen, Izabel Regina Fischer Rubira de; Lauris, José Roberto Pereira; Damante, José Humberto

2018-01-01

Idiopathic Bone Cavity (IBC) or Simple Bone Cyst (SBC) is a non- epithelialized bone cavity with serosanguinous fluid content or empty. There is a literature debate regarding its pathogenesis that remains unclear. The main treatment option is the surgical exploration, although there are successful cases described in the literature in which just a follow-up with clinical and radiographic evaluation was performed. Objective This study aimed to assess the spontaneous resolution of idiopathic bone cavity untreated by surgery. Material and Methods Twenty-one patients diagnosed with surgically untreated IBC were submitted to a follow-up protocol modified from Damante, Guerra, and Ferreira5 (2002). A clinical and radiographic evaluation was performed in 13 patients (13/21), while eight patients (8/21) were only radiographically evaluated. Three observers evaluated the panoramic radiographs of 21 patients and the Kappa test was performed by intra and inter-examiners. Inductive and descriptive statistics were applied to the results. Results Only one patient had a positive response to palpation and percussion of the teeth in the cyst area. Most of the cysts evaluated were rated as 3 (lesion "in involution"), 4 (lesion "almost completely resolved"), or 5 ("completely resolved"). Conclusions We observed progressive spontaneous resolution of IBC. Most cysts were found in the recovery process in different follow-up periods. Patient's follow-up, without surgery, may be considered after the diagnosis based on epidemiological, clinical, and radiographic features of the lesion.

21 CFR 1308.31 - Application for exemption of a nonnarcotic prescription product.

Code of Federal Regulations, 2011 CFR

2011-04-01

... the following information: (1) The complete quantitative composition of the dosage form. (2... product including animal investigations and clinical evaluations and studies, with emphasis on the psychic...

Radiation Oncology Medical Student Clerkship: Implementation and Evaluation of a Bi-institutional Pilot Curriculum

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

Golden, Daniel W., E-mail: dgolden@radonc.uchicago.edu; Spektor, Alexander; Rudra, Sonali

Purpose: To develop and evaluate a structured didactic curriculum to complement clinical experiences during radiation oncology clerkships at 2 academic medical centers. Methods and Materials: A structured didactic curriculum was developed to teach fundamentals of radiation oncology and improve confidence in clinical competence. Curriculum lectures included: (1) an overview of radiation oncology (history, types of treatments, and basic clinic flow); (2) fundamentals of radiation biology and physics; and (3) practical aspects of radiation treatment simulation and planning. In addition, a hands-on dosimetry session taught students fundamentals of treatment planning. The curriculum was implemented at 2 academic departments in 2012. Studentsmore » completed anonymous evaluations using a Likert scale to rate the usefulness of curriculum components (1 = not at all, 5 = extremely). Likert scores are reported as (median [interquartile range]). Results: Eighteen students completed the curriculum during their 4-week rotation (University of Chicago n=13, Harvard Longwood Campus n=5). All curriculum components were rated as extremely useful: introduction to radiation oncology (5 [4-5]); radiation biology and physics (5 [5-5]); practical aspects of radiation oncology (5 [4-5]); and the treatment planning session (5 [5-5]). Students rated the curriculum as “quite useful” to “extremely useful” (1) to help students understand radiation oncology as a specialty; (2) to increase student comfort with their specialty decision; and (3) to help students with their future transition to a radiation oncology residency. Conclusions: A standardized curriculum for medical students completing a 4-week radiation oncology clerkship was successfully implemented at 2 institutions. The curriculum was favorably reviewed. As a result of completing the curriculum, medical students felt more comfortable with their specialty decision and better prepared to begin radiation oncology residency.« less

An architecture for a continuous, user-driven, and data-driven application of clinical guidelines and its evaluation.

PubMed

Shalom, Erez; Shahar, Yuval; Lunenfeld, Eitan

2016-02-01

Design, implement, and evaluate a new architecture for realistic continuous guideline (GL)-based decision support, based on a series of requirements that we have identified, such as support for continuous care, for multiple task types, and for data-driven and user-driven modes. We designed and implemented a new continuous GL-based support architecture, PICARD, which accesses a temporal reasoning engine, and provides several different types of application interfaces. We present the new architecture in detail in the current paper. To evaluate the architecture, we first performed a technical evaluation of the PICARD architecture, using 19 simulated scenarios in the preeclampsia/toxemia domain. We then performed a functional evaluation with the help of two domain experts, by generating patient records that simulate 60 decision points from six clinical guideline-based scenarios, lasting from two days to four weeks. Finally, 36 clinicians made manual decisions in half of the scenarios, and had access to the automated GL-based support in the other half. The measures used in all three experiments were correctness and completeness of the decisions relative to the GL. Mean correctness and completeness in the technical evaluation were 1±0.0 and 0.96±0.03 respectively. The functional evaluation produced only several minor comments from the two experts, mostly regarding the output's style; otherwise the system's recommendations were validated. In the clinically oriented evaluation, the 36 clinicians applied manually approximately 41% of the GL's recommended actions. Completeness increased to approximately 93% when using PICARD. Manual correctness was approximately 94.5%, and remained similar when using PICARD; but while 68% of the manual decisions included correct but redundant actions, only 3% of the actions included in decisions made when using PICARD were redundant. The PICARD architecture is technically feasible and is functionally valid, and addresses the realistic continuous GL-based application requirements that we have defined; in particular, the requirement for care over significant time frames. The use of the PICARD architecture in the domain we examined resulted in enhanced completeness and in reduction of redundancies, and is potentially beneficial for general GL-based management of chronic patients. Copyright © 2015 Elsevier Inc. All rights reserved.

Parental consanguineous marriages and clinical response to chemotherapy in locally advanced breast cancer patients.

PubMed

Saadat, Mostafa; Khalili, Maryam; Omidvari, Shahpour; Ansari-Lari, Maryam

2011-03-28

The main aim of the present study was investigating the association between parental consanguinity and clinical response to chemotherapy in females affected with locally advanced breast cancer. A consecutive series of 92 patients were prospectively included in this study. Clinical assessment of treatment was accomplished by comparing initial tumor size with preoperative tumor size using revised RECIST guideline (version 1.1). Clinical response defined as complete response, partial response and no response. The Kaplan-Meier survival analysis were used to evaluate the association of parental marriages (first cousin vs unrelated marriages) and clinical response to chemotherapy (complete and partial response vs no response). Number of courses of chemotherapy was considered as time, in the analysis. Kaplan-Meier analysis revealed that offspring of unrelated marriages had poorer response to chemotherapy (log rank statistic=5.10, df=1, P=0.023). Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Employee use and perceived benefit of a complementary and alternative medicine wellness clinic at a major military hospital: evaluation of a pilot program.

PubMed

Duncan, Alaine D; Liechty, Janet M; Miller, Cathy; Chinoy, Gail; Ricciardi, Richard

2011-09-01

The objectives of this study were to examine the feasibility of a weekly on-site complementary and alternative medicine (CAM) wellness clinic for staff at a military hospital, and to describe employees' perceptions of program effectiveness. The study setting was the Restore & Renew(®) Wellness Clinic at a United States Department of Defense hospital. The subjects were hospital nurses, physicians, clinicians, support staff, and administrators. The walk-in wellness clinic was open 8:00 am-2:00 pm 1 day a week. Participants selected one or more modalities each visit: ear acupuncture, clinical acupressure, and Zero Balancing.(®) A self-report survey was done after each clinic visit to evaluate clinic features and perceived impact on stress-related symptoms, compassion for patients, sleep, and workplace or personal relationships. Surveys completed after first-time and repeat visits (n=2,756 surveys) indicated that most participants agreed or strongly agreed they felt more relaxed after sessions (97.9%), less stress (94.5%), more energy (84.3%), and less pain (78.8%). Ninety-seven percent (97%) would recommend it to a co-worker. Among surveys completed after five or more visits, more than half (59%-85%) strongly agreed experiencing increased compassion with patients, better sleep, improved mood, and more ease in relations with co-workers. Perceived benefits were sustained and enhanced by number of visits. The most frequently reported health habit changes were related to exercise, stress reduction, diet/nutrition, and weight loss. This evaluation suggests that a hospital-based wellness clinic based on CAM principles and modalities is feasible, well-utilized, and perceived by most participants to have positive health benefits related to stress reduction at work, improved mood and sleep, and lifestyle.

Faculty Evaluations Correlate Poorly with Medical Student Examination Performance in a Fourth-Year Emergency Medicine Clerkship.

PubMed

Dubosh, Nicole M; Fisher, Jonathan; Lewis, Jason; Ullman, Edward A

2017-06-01

Clerkship directors routinely evaluate medical students using multiple modalities, including faculty assessment of clinical performance and written examinations. Both forms of evaluation often play a prominent role in final clerkship grade. The degree to which these modalities correlate in an emergency medicine (EM) clerkship is unclear. We sought to correlate faculty clinical evaluations with medical student performance on a written, standardized EM examination of medical knowledge. This is a retrospective study of fourth-year medical students in a 4-week EM elective at one academic medical center. EM faculty performed end of shift evaluations of students via a blinded online system using a 5-point Likert scale for 8 domains: data acquisition, data interpretation, medical knowledge base, professionalism, patient care and communication, initiative/reliability/dependability, procedural skills, and overall evaluation. All students completed the National EM M4 Examination in EM. Means, medians, and standard deviations for end of shift evaluation scores were calculated, and correlations with examination scores were assessed using a Spearman's rank correlation coefficient. Thirty-nine medical students with 224 discrete faculty evaluations were included. The median number of evaluations completed per student was 6. The mean score (±SD) on the examination was 78.6% ± 6.1%. The examination score correlated poorly with faculty evaluations across all 8 domains (ρ 0.074-0.316). Faculty evaluations of medical students across multiple domains of competency correlate poorly with written examination performance during an EM clerkship. Educators need to consider the limitations of examination score in assessing students' ability to provide quality patient clinical care. Copyright © 2016 Elsevier Inc. All rights reserved.

Association of Research Self-Efficacy with Medical Student Career Interests, Specialization, and Scholarship: A Case Study

ERIC Educational Resources Information Center

Bierer, S. Beth; Prayson, Richard A.; Dannefer, Elaine F.

2015-01-01

This study used variables proposed in social cognitive career theory (SCCT) to focus the evaluation of a research curriculum at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University (CCLCM). Eight cohorts of CCLCM medical students completed a web-based version of the six-scale Clinical Research Appraisal…

Effectiveness of a Therapeutic Summer Camp for Children with ADHD: Phase I Clinical Intervention Trial

ERIC Educational Resources Information Center

Hantson, Julie; Wang, Pan Pan; Grizenko-Vida, Michael; Ter-Stepanian, Marina; Harvey, William; Joober, Ridha; Grizenko, Natalie

2012-01-01

Objective: The objective of this study was to evaluate the effectiveness of a 2-week therapeutic summer day camp for children with ADHD, which included a social skills training program and parent psychoeducation and training program. This was an open-label, nonrandomized Phase I Clinical Intervention Trial. Method: Parents completed the Weiss…

Evaluation of a Problem-based Learning Workshop Using Pre- and Post-test Objective Structured Clinical Examinations and Standardized Patients.

ERIC Educational Resources Information Center

Davis, Paul; Kvern, Brent; Donen, Neil; Andrews, Elaine; Nixon, Olga

2000-01-01

Pre/posttest data on 40 physicians who completed problem-based clinical scenarios on osteoporosis revealed that 39 showed improvement or modest change in postworkshop scores, especially in terms of management of male patients, determination of risk factors, and use and interpretation of bone density tests. (SK)

Development of a Learning-Oriented Computer Assisted Instruction Designed to Improve Skills in the Clinical Assessment of the Nutritional Status: A Pilot Evaluation

PubMed Central

García de Diego, Laura; Cuervo, Marta; Martínez, J. Alfredo

2015-01-01

Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient’s nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient’s needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum. PMID:25978456

Development of a learning-oriented computer assisted instruction designed to improve skills in the clinical assessment of the nutritional status: a pilot evaluation.

PubMed

García de Diego, Laura; Cuervo, Marta; Martínez, J Alfredo

2015-01-01

Computer assisted instruction (CAI) is an effective tool for evaluating and training students and professionals. In this article we will present a learning-oriented CAI, which has been developed for students and health professionals to acquire and retain new knowledge through the practice. A two-phase pilot evaluation was conducted, involving 8 nutrition experts and 30 postgraduate students, respectively. In each training session, the software developed guides users in the integral evaluation of a patient's nutritional status and helps them to implement actions. The program includes into the format clinical tools, which can be used to recognize possible patient's needs, to improve the clinical reasoning and to develop professional skills. Among them are assessment questionnaires and evaluation criteria, cardiovascular risk charts, clinical guidelines and photographs of various diseases. This CAI is a complete software package easy to use and versatile, aimed at clinical specialists, medical staff, scientists, educators and clinical students, which can be used as a learning tool. This application constitutes an advanced method for students and health professionals to accomplish nutritional assessments combining theoretical and empirical issues, which can be implemented in their academic curriculum.

Essentials of Pediatric Emergency Medicine Fellowship: Part 3: Clinical Education and Experience.

PubMed

Mittiga, Matthew R; Nagler, Joshua; Eldridge, Charles D; Ishimine, Paul; Zuckerbraun, Noel S; McAneney, Constance M

2016-07-01

This article is the third in a 7-part series that aims to comprehensively describe the current state and future directions of pediatric emergency medicine fellowship training from the essential requirements to considerations for successfully administering and managing a program to the careers that may be anticipated upon program completion. This article focuses on the clinical aspects of fellowship training including the impact of the clinical environment, modalities for teaching and evaluation, and threats and opportunities in clinical education.

Implementing clinical guidelines to prevent catheter-associated urinary tract infections and improve catheter care in nursing homes: Systematic review.

PubMed

Gould, Dinah; Gaze, Sarah; Drey, Nicholas; Cooper, Tracey

2017-05-01

Catheter-associated urinary tract infection is the most common health care-associated infection, is considered avoidable, and has cost implications for health services. Prevalence is high in nursing homes, but little research has been undertaken to establish whether implementing clinical guidelines can reduce infection rates in long-term care or improve quality of urinary catheter care. Systematic search and critical appraisal of the literature. Three studies evaluated the impact of implementing a complete clinical guideline. Five additional studies evaluated the impact of implementing individual elements of a clinical guideline. Prevention of catheter-associated urinary tract infection in nursing homes has received little clinical or research attention. Studies concerned with whole guideline implementation emerged as methodologically poor using recognized criteria for critically appraising epidemiologic studies concerned with infection prevention. Research evaluating the impact of single elements of clinical guidelines is more robust, and their findings could be implemented to prevent urinary infections in nursing homes. Copyright © 2017. Published by Elsevier Inc.

Patient satisfaction with psychotropic drugs: sensitivity to change and relationship to clinical status, quality-of-life, compliance and effectiveness of treatment. Results from a nation-wide 6-month prospective study.

PubMed

Gasquet, Isabelle; Tcherny-Lessenot, Stéphanie; Lépine, Jean-Pierre; Falissard, Bruno

2006-12-01

To see if patient satisfaction with psychotropics (PSP) could be used as a patient-oriented outcome variable in the evaluation of PSP drugs in clinical epidemiological studies, relationships between PSP, clinical status, QoL, compliance and the type of antipsychotic were analyzed. Elements of validation of PSP were also assessed. In a 6-month prospective study, 933 schizophrenic outpatients with initiation or change to their antipsychotic treatment were enrolled. Psychiatrists completed five CGI-SCH scales (positive, negative, cognitive, depressive and global), hospitalization, compliance, and prescription variables. Patients completed PSP, EuroQoL scales, sexual function and compliance variables. A satisfactory structural equation model was obtained showing significant relationships PSP/compliance (coef.=0.16), QoL/PSP (coef.=0.37), clinical status/QoL (coef.=0.61), clinical status/compliance (coef.=0.09). Patients receiving olanzapine were more satisfied than patients receiving other atypicals (coef.=012) and had better clinical status than patients treated with typicals (coef.=0.08). Evolution of PSP was related to clinical status, QoL, and continuation of treatment (all P<001). Sensitivity to change of PSP was moderate (effect size=0.2). PSP produced consistent results in relation to validated outcome variables. However, a single-item measure was not sufficiently sensitive to change. Multi-item questionnaires evaluating different dimensions are needed.

The impact of missing trauma data on predicting massive transfusion

PubMed Central

Trickey, Amber W.; Fox, Erin E.; del Junco, Deborah J.; Ning, Jing; Holcomb, John B.; Brasel, Karen J.; Cohen, Mitchell J.; Schreiber, Martin A.; Bulger, Eileen M.; Phelan, Herb A.; Alarcon, Louis H.; Myers, John G.; Muskat, Peter; Cotton, Bryan A.; Wade, Charles E.; Rahbar, Mohammad H.

2013-01-01

INTRODUCTION Missing data are inherent in clinical research and may be especially problematic for trauma studies. This study describes a sensitivity analysis to evaluate the impact of missing data on clinical risk prediction algorithms. Three blood transfusion prediction models were evaluated utilizing an observational trauma dataset with valid missing data. METHODS The PRospective Observational Multi-center Major Trauma Transfusion (PROMMTT) study included patients requiring ≥ 1 unit of red blood cells (RBC) at 10 participating U.S. Level I trauma centers from July 2009 – October 2010. Physiologic, laboratory, and treatment data were collected prospectively up to 24h after hospital admission. Subjects who received ≥ 10 RBC units within 24h of admission were classified as massive transfusion (MT) patients. Correct classification percentages for three MT prediction models were evaluated using complete case analysis and multiple imputation. A sensitivity analysis for missing data was conducted to determine the upper and lower bounds for correct classification percentages. RESULTS PROMMTT enrolled 1,245 subjects. MT was received by 297 patients (24%). Missing percentage ranged from 2.2% (heart rate) to 45% (respiratory rate). Proportions of complete cases utilized in the MT prediction models ranged from 41% to 88%. All models demonstrated similar correct classification percentages using complete case analysis and multiple imputation. In the sensitivity analysis, correct classification upper-lower bound ranges per model were 4%, 10%, and 12%. Predictive accuracy for all models using PROMMTT data was lower than reported in the original datasets. CONCLUSIONS Evaluating the accuracy clinical prediction models with missing data can be misleading, especially with many predictor variables and moderate levels of missingness per variable. The proposed sensitivity analysis describes the influence of missing data on risk prediction algorithms. Reporting upper/lower bounds for percent correct classification may be more informative than multiple imputation, which provided similar results to complete case analysis in this study. PMID:23778514

Trauma leadership: does perception drive reality?

PubMed

Sakran, Joseph V; Finneman, Bo; Maxwell, Chris; Sonnad, Seema S; Sarani, Babak; Pascual, Jose; Kim, Patrick; Schwab, C William; Sims, Carrie

2012-01-01

Leadership plays a key role in trauma team management and might affect the efficiency of patient care. Our hypothesis was that a positive relationship exists between the trauma team members' perception of leadership and the efficiency of the injured patient's initial evaluation. We conducted a prospective observational study evaluating trauma attending leadership (TAL) over 5 months at a level 1 trauma center. After the completion of patient care, trauma team members evaluated the TAL's ability using a modified Campbell Leadership Descriptor Survey tool. Scores ranged from 18 (ineffective leader) to 72 (perfect score). Clinical efficiency was measured prospectively by recording the time needed to complete an advanced trauma life support (ATLS)-directed resuscitation. Assessment times across Leadership score groups were compared using Kruskal-Wallis and Mann-Whitney tests (p < 0.05, statistically significant). Seven attending physicians were included with a postfellowship experience ranging from ≤1 to 11 years. The average leadership score was 59.8 (range, 27-72). Leadership scores were divided into 3 groups post facto: low (18-45), medium (46-67), and high (68-72). The teams directed by surgeons with low scores took significantly longer than teams directed by surgeons with high scores to complete the secondary survey (14 ± 4 minutes in contrast to 11 ± 2 minutes, p < 0.009) and to transport the patient for CT evaluation (19 ± 5 minutes in contrast to 14 ± 4 minutes; p < 0.001). Attending surgeon experience also affected clinical efficiency with teams directed by less experienced surgeons taking significantly longer to complete the primary survey (p < 0.05). The trauma team's perception of leadership is associated positively with clinical efficiency. As such, more formal leadership training could potentially improve patient care and should be included in surgical education. Copyright © 2012 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

A sentence completion procedure as an alternative to the Autobiographical Memory Test for assessing overgeneral memory in non-clinical populations

PubMed Central

Raes, Filip; Hermans, Dirk; Williams, J. Mark G.; Eelen, Paul

2007-01-01

Overgeneral memory (OGM) has been proposed as a vulnerability factor for depression (Williams et al., 2007) or depressive reactivity to stressful life-events (e.g., Gibbs & Rude, 2004). Traditionally, a cue word procedure known as the Autobiographical Memory Test (AMT; Williams & Broadbent, 1986) is used to assess OGM. Although frequently and validly used in clinical populations, there is evidence suggesting that the AMT is insufficiently sensitive to measure OGM in non-clinical groups. Study 1 evaluated the usefulness of a sentence completion method to assess OGM in non-clinical groups, as an alternative to the AMT. Participants were 197 students who completed the AMT, the Sentence Completion for Events from the Past Test (SCEPT), a depression measure, and visual analogue scales assessing ruminative thinking. Results showed that the mean proportion of overgeneral responses was markedly higher for the SCEPT than for the standard AMT. Also, overgeneral responding on the SCEPT was positively associated to depression scores and depressive rumination scores, whereas overgeneral responding on the AMT was not. Results suggest that the SCEPT, relative to the AMT, is a more sensitive instrument to measure OGM, at least in non-clinical populations. Study 2 further showed that this enhanced sensitivity is most likely due to the omission of the instruction to be specific rather than to the SCEPT's sentence completion format (as opposed to free recall to cue words). PMID:17613793

A sentence completion procedure as an alternative to the Autobiographical Memory Test for assessing overgeneral memory in non-clinical populations.

PubMed

Raes, Filip; Hermans, Dirk; Williams, J Mark G; Eelen, Paul

2007-07-01

Overgeneral memory (OGM) has been proposed as a vulnerability factor for depression (Williams et al., 2007) or depressive reactivity to stressful life-events (e.g., Gibbs & Rude, 2004). Traditionally, a cue word procedure known as the Autobiographical Memory Test (AMT; Williams & Broadbent, 1986) is used to assess OGM. Although frequently and validly used in clinical populations, there is evidence suggesting that the AMT is insufficiently sensitive to measure OGM in non-clinical groups. Study 1 evaluated the usefulness of a sentence completion method to assess OGM in non-clinical groups, as an alternative to the AMT. Participants were 197 students who completed the AMT, the Sentence Completion for Events from the Past Test (SCEPT), a depression measure, and visual analogue scales assessing ruminative thinking. Results showed that the mean proportion of overgeneral responses was markedly higher for the SCEPT than for the standard AMT. Also, overgeneral responding on the SCEPT was positively associated to depression scores and depressive rumination scores, whereas overgeneral responding on the AMT was not. Results suggest that the SCEPT, relative to the AMT, is a more sensitive instrument to measure OGM, at least in non-clinical populations. Study 2 further showed that this enhanced sensitivity is most likely due to the omission of the instruction to be specific rather than to the SCEPT's sentence completion format (as opposed to free recall to cue words).

Teaching and Evaluating Point of Care Learning with an Internet-Based Clinical-Question Portfolio

ERIC Educational Resources Information Center

Green, Michael L.; Reddy, Siddharta G.; Holmboe, Eric

2009-01-01

Introduction: Diplomates in the American Board of Internal Medicine (ABIM) Maintenance of Certification (MOC) program satisfy the self-evaluation of medical knowledge requirement by completing open-book multiple-choice exams. However, this method remains unlikely to affect practice change and often covers content areas not relevant to diplomates'…

Imaging technique for the complete edentulous patient treated conventionally or with mini implant overdenture

PubMed Central

Meleşcanu Imre, M; Preoteasa, E; Țâncu, AM; Preoteasa, CT

2013-01-01

Rationale. The imaging methods are more and more used in the clinical process of modern dentistry. Once the implant based treatment alternatives are nowadays seen as being the standard of care in edentulous patients, these techniques must be integrated in the complete denture treatment. Aim. The study presents some evaluation techniques for the edentulous patient treated by conventional dentures or mini dental implants (mini SKY Bredent) overdentures, using the profile teleradiography. These offer data useful for an optimal positioning of the artificial teeth and the mini dental implants, favoring to obtain an esthetic and functional treatment outcome. We proposed also a method to conceive a simple surgical guide that allows the prosthetically driven implants placement. Material and method. Clinical case reports were made, highlighting the importance of cephalometric evaluation on lateral teleradiographs in complete edentulous patients. A clinical case that gradually reports the surgical guide preparation (Bredent silicon radio opaque), in order to place the mini dental implants in the best prosthetic and anatomic conditions, was presented. Conclusions. The profile teleradiograph is a useful tool for the practitioner. It allows establishing the optimal site for implant placement, in a good relation with the overdenture. The conventional denture can be easily and relatively costless transformed in a surgical guide used during implant placement. PMID:23599828

A Drug Interactions Elective Course

PubMed Central

2009-01-01

Objectives To evaluate the impact of a drug interactions elective course on student knowledge and skills. Design A drug interactions elective which focused on assessment and application of drug interaction information and identification and management of commonly encountered drug interactions by therapeutic category was offered to third-year PharmD students. Students were expected to (1) determine whether a given interaction was clinically significant or required pharmacist intervention, and (2) make rational, scientifically sound, practical recommendations for management of drug interactions. Evaluation and Assessment Assessment included course evaluations, student self-assessments, and knowledge and skills assessments. Students who completed the course were more confident in their abilities relating to drug interactions than students who did not complete the course. Students who completed the course scored significantly better in all areas of the assessment compared to students who did not complete the course. Course evaluation results were also positive. Conclusion A course devoted to the identification and management of drug interactions improved PharmD students' knowledge and skills and could potentially improve the patient care they provide in the future. PMID:19657505

Clinical efficacy of a novel elimination diet composed of a mixture of amino acids and potatoes in dogs with non-seasonal pruritic dermatitis.

PubMed

Kawarai, Shinpei; Ishihara, Jun; Masuda, Kenichi; Yasuda, Nobutaka; Ohmori, Keitaro; Sakaguchi, Masahiro; Asami, Yasuhiro; Tsujimoto, Hajime

2010-11-01

There has been a need for improvement of the elimination diet used for diagnosis of adverse food reaction (AFR) in dogs. Recently, a novel elimination diet composed of a mixture of amino acids and potatoes was developed. We evaluated the efficacy of the elimination diet for diagnosis of AFR in dogs. Twenty dogs that were suspected to have allergic dermatitis were enrolled in a 2-month food elimination trial using the diet. Before and after the trial, the clinical symptoms were evaluated based on the change in canine atopic dermatitis extent and severity index (CADESI), pruritus score and medication score. Of the 20 dogs, 15 completed the food elimination trial. The remaining 5 dogs were removed from the trial because of diet unpalatability, skin disease progression or diarrhea. On the basis of evaluation of the clinical scores, we observed that the clinical symptoms improved in 11 of the 15 dogs that completed the food elimination trial. Provocative challenge was performed in 10 of the 11 dogs that showed improvement in their clinical symptoms. Of the 10 dogs, 7 were diagnosed as having AFR against food ingredients such as pork, beef, chicken and wheat because their skin symptoms reappeared after intake of these ingredients. The results of the food elimination trial and the provocative challenge indicated the usefulness of the novel elimination diet for diagnosis of AFR.

Prospective evaluation of surgical management of sliding hiatal hernia and gastroesophageal reflux in dogs.

PubMed

Mayhew, Philipp D; Marks, Stanley L; Pollard, Rachel; Culp, William T N; Kass, Philip H

2017-11-01

To evaluate response to surgical management of sliding hiatal hernia (SHH) and gastroesophageal reflux (GER) in dogs using standardized clinical scoring, videofluoroscopic swallow studies, and impedance planimetry. Prospective clinical trial. A total of 17 client-owned dogs. Dogs were included if they had clinical signs and videofluoroscopic evidence of SHH and/or GER. Owners were asked to complete a standardized canine dysphagia assessment tool (CDAT) preoperatively and postoperatively. Conscious videofluoroscopic swallowing studies and impedance planimetry (IP) were used to evaluate esophageal function and lower esophageal sphincter location and geometry preoperatively and in a subsection of dogs postoperatively. Preoperatively, 13/17 dogs included in the study had a history of regurgitation, and 4/17 had radiographic evidence of aspiration pneumonia. Postprandial regurgitation improved in 8/10 dogs with preoperative regurgitation, and for which completed preoperative and postoperative CDAT questionnaires were available (P < .01). The hiatal hernia severity score improved postoperatively (P = .046) in dogs with preoperative and postoperative videofluoroscopic swallowing studies (n = 12). However, hernia frequency score (P = .2) and IP parameters did not differ significantly between time points. Clinical signs of SHH generally improved with surgery but did not consistently resolve. Videofluoroscopic studies provide evidence that GER and SHH can persist postoperatively in some patients. Based on IP findings, clinical improvement may be attributed to a mechanism independent of lower esophageal sphincter attenuation. © 2017 The American College of Veterinary Surgeons.

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

PubMed Central

Fathauer, L; Meek, J.

2012-01-01

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

Coil-Assisted Retrograde Transvenous Obliteration (CARTO) for the Treatment of Portal Hypertensive Variceal Bleeding: Preliminary Results

PubMed Central

Lee, Edward W; Saab, Sammy; Gomes, Antoinette S; Busuttil, Ronald; McWilliams, Justin; Durazo, Francisco; Han, Steven-Huy; Goldstein, Leonard; Tafti, Bashir A; Moriarty, John; Loh, Christopher T; Kee, Stephen T

2014-01-01

OBJECTIVES: To describe the technical feasibility, safety, and clinical outcomes of coil-assisted retrograde transvenous obliteration (CARTO) in treating portal hypertensive non-esophageal variceal hemorrhage. METHODS: From October 2012 to December 2013, 20 patients who received CARTO for the treatment of portal hypertensive non-esophageal variceal bleeding were retrospectively evaluated. All 20 patients had at least 6-month follow-up. All patients had detachable coils placed to occlude the efferent shunt and retrograde gelfoam embolization to achieve complete thrombosis/obliteration of varices. Technical success, clinical success, rebleeding, and complications were evaluated at follow-up. RESULTS: A 100% technical success rate (defined as achieving complete occlusion of efferent shunt with complete thrombosis/obliteration of bleeding varices and/or stopping variceal bleeding) was demonstrated in all 20 patients. Clinical success rate (defined as no variceal rebleeding) was 100%. Follow-up computed tomography after CARTO demonstrated decrease in size with complete thrombosis and disappearance of the varices in all 20 patients. Thirteen out of the 20 had endoscopic confirmation of resolution of varices. Minor post-CARTO complications, including worsening of esophageal varices (not bleeding) and worsening of ascites/hydrothorax, were noted in 5 patients (25%). One patient passed away at 24 days after the CARTO due to systemic and portal venous thrombosis and multi-organ failure. Otherwise, no major complication was noted. No variceal rebleeding was noted in all 20 patients during mean follow-up of 384±154 days. CONCLUSIONS: CARTO appears to be a technically feasible and safe alternative to traditional balloon-occluded retrograde transvenous obliteration or transjugular intrahepatic portosystemic shunt, with excellent clinical outcomes in treating portal hypertensive non-esophageal variceal bleeding. PMID:25273155

Changing CHANGE: adaptations of an evidence-based telehealth cardiovascular disease risk reduction intervention.

PubMed

Zullig, Leah L; McCant, Felicia; Silberberg, Mina; Johnson, Fred; Granger, Bradi B; Bosworth, Hayden B

2018-03-01

Relatively few successful medication adherence interventions are translated into real-world clinical settings. The Prevention of Cardiovascular Outcomes in African Americans with Diabetes (CHANGE) intervention was originally conceived as a randomized controlled trial to improve cardiovascular disease-related medication adherence and health outcomes. The purpose of the study was to describe the translation of the CHANGE trial into two community-based clinical programs. CHANGE 2 was available to Medicaid patients with diabetes and hypertension whose primary care homes were part of a care management network in the Northern Piedmont region of North Carolina. CHANGE 3 was available to low-income patients receiving care in three geographical areas with multiple chronic conditions at low or moderate risk for developing cardiovascular disease. Adaptations were made to ensure fit with available organizational resources and the patient population's health needs. Data available for evaluation are presented. For CHANGE 2, we evaluated improvement in A1c control using paired t test. For both studies, we describe feasibility measured by percentage of patients who completed the curriculum. CHANGE 2 involved 125 participants. CHANGE 3 had 127 participants. In CHANGE 2, 69 participants had A1c measurements at baseline and 12-month follow-up; A1c improved from 8.4 to 7.8 (p = .008). In CHANGE 3, interventionists completed 47% (n = 45) of calls to enroll participants at the 4-month encounter, and among those eligible for a 12-month call (n = 52), 21% of 12-month calls were completed with participants. In CHANGE 2, 40% of participants (n = 50) completed all 12 encounters. Thoughtful adaptation is critical to translate clinical trials into community-based clinic settings. Successful implementation of adapted evidence-based interventions may be feasible and can positively affect patients' disease control.

Can it be done? Implementing adolescent clinical preventive services.

PubMed Central

Ozer, E M; Adams, S H; Lustig, J L; Millstein, S G; Camfield, K; El-Diwany, S; Volpe, S; Irwin, C E

2001-01-01

OBJECTIVE: To evaluate the implementation of an intervention to increase the delivery of adolescent preventive services within a large managed care organization. Target health areas were tobacco, alcohol, sexual behavior, and safety (seat belt and helmet use). DATA SOURCE/STUDY DESIGN: Adolescent reports of clinician screening and counseling were obtained from adolescents who attended well visits with their primary care providers. A prepost study design was used to evaluate the preventive services intervention. The intervention had three components: (1) 89 clinicians from three outpatient pediatric clinics attended a training to increase the delivery of preventive services; (2) customized adolescent screening and provider charting forms were integrated into the clinics; and (3) the resources of a health educator were provided to the clinics. DATA COLLECTION: Following a visit, adolescents completed surveys reporting on clinician screening and counseling for each of the target risk areas. Preimplementation (three months), 104 adolescents completed surveys. Postimplementation of the training, tools, and health educator intervention, 211 adolescents completed surveys (five months). For 18 months postimplementation clinicians delivered services and 998 adolescents completed surveys. PRINCIPAL FINDINGS: Chi-square analyses of changes in screening from preimplementation to postimplementation showed that screening increased in all areas (p < .000), with an average increase in screening rates from 47 percent to 94 percent. Postimplementation counseling in all areas also increased significantly, with an average increase in counseling rates from 39 percent to 91 percent. There were slight decreases in screening from postimplementation to follow-up. CONCLUSIONS: This study offers support for the efficacy of providing training, tools, and resources as a method for increasing preventive screening and counseling of adolescents across multiple risky health behaviors during a routine office visit. PMID:16148966

[Correlation of psychoemotional status and adaptation to complete dentures].

PubMed

Barkan, I Yu; Stafeev, A A; Repin, V S

2015-01-01

Patients with full adentia are characterized by the formation of specific psycho-emotional status. Rational psychotherapeutic support of these patients largely determines the efficiency of dental prosthetic treatment. At the same time, the definition of mental and emotional status is not included in the diagnostic examination protocol. Considering the above the purpose of the study was to evaluate mental and emotional status of patients receiving complete dentures. Prosthetic rehabilitation of 30 patients with complete teeth loss was performed and clinical evaluation and evaluation of mental and emotional status were carried out before and after treatment. Patients with negative experiences of prosthetics showed a higher level of personal and situational anxiety. There was correlation of adaptation to removable dentures and the patient's personality traits. It is determined that emotional instability during treatment tends to decrease affecting the timing of adaptation to complete dentures. It is noted that patients with repeated prosthetics have earlier recovery of coordination ability of the masticatory muscles.

Overview of a pharmacist anticoagulation certificate program.

PubMed

Kirk, Julienne K; Edwards, Rebecca; Brewer, Andrew; Miller, Cathey; Bray, Bryan; Groce, James B

2017-07-01

To describe the design of an ongoing anticoagulation certificate program and annual renewal update for pharmacists. Components of the anticoagulation certificate program include home study, pre- and posttest, live sessions, case discussions with evaluation and presentation, an implementation plan, and survey information (program evaluation and use in practice). Clinical reasoning skills were assessed through case work-up and evaluation prior to live presentation. An annual renewal program requires pharmacists to complete home study and case evaluations. A total of 361 pharmacists completed the anticoagulation certificate program between 2002 and 2015. Most (62%) practiced in ambulatory care and 38% in inpatient care settings (8% in both). In the past four years, 71% were working in or starting anticoagulation clinics in ambulatory and inpatient settings. In their evaluations of the program, an average of 90% of participants agreed or strongly agreed the lecture material was relevant and objectives were met. Pharmacists are able to apply knowledge and skills in management of anticoagulation. This structured practice-based continuing education program was intended to enhance pharmacy practice and has achieved that goal. The certificate program in anticoagulation was relevant to pharmacists who attended the program. Copyright © 2017. Published by Elsevier Inc.

Evaluating depressive symptoms in hypomanic and manic episodes using a structured diagnostic tool: validation of a new Mini International Neuropsychiatric Interview (M.I.N.I.) module for the DSM-5 'With Mixed Features' specifier.

PubMed

Hergueta, Thierry; Weiller, Emmanuelle

2013-01-01

The Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5), includes a new 'With Mixed Features' specifier for mood episodes. In (hypo-)manic episodes, the specifier is given if three or more depressive symptoms are present nearly every day during the episode. A new module of the Mini International Neuropsychiatric Interview (M.I.N.I.) has been developed as a patient-completed questionnaire to evaluate the DSM-5 specifier for (hypo-)manic episodes. The objective of this study was to validate this new module. In Phase I, patients with a manic episode in the past 6 months completed the module and were asked whether the wording was clear, understandable, relevant and specific. Based on their feedback, the module was refined and finalised. In Phase II, psychiatrists each invited five patients to complete the module. The psychiatrists completed record forms for these five patients, which included their diagnoses, made according to DSM-5 criteria during clinical interviewing. The module was validated by comparing depressive symptoms reported by the patients themselves using the M.I.N.I. module with those evaluated by their psychiatrist using DSM-5 criteria during clinical interviewing. In Phase I, a few changes were made to the M.I.N.I. module based on feedback from 20 patients (60% of whom had mixed features). In Phase II, 23 psychiatrists completed record forms for 115 patients, 99 (86.1%) of whom completed the M.I.N.I. module. Agreement between psychiatrists' DSM-5 diagnoses and patients' M.I.N.I. responses was substantial (Cohen's kappa coefficient, 0.60). The overall sensitivity of the M.I.N.I. was 0.91 and its specificity was 0.70. Sensitivity ranged from 0.63 for psychomotor retardation to 0.90 for suicidal thoughts. Specificity ranged from 0.63 for diminished interest/pleasure to 0.90 for suicidal thoughts. The module's positive and negative predictive values were 0.72 and 0.90, respectively. In summary, the M.I.N.I. module demonstrated good concurrent validity with psychiatrists' evaluation of DSM-5 mixed features in manic patients, accurately detecting mixed features with limited risk of over-diagnosis. Due to its simplicity, the M.I.N.I. module could be incorporated into routine psychiatric evaluation of patients with manic episodes. It could also provide a valuable standardised tool for clinical and epidemiological research.

Efficacy Study of a Fully Implanted Neuroprosthesis for Functional Benefit to Individuals with Tetraplegia

DTIC Science & Technology

2015-10-01

function for individuals with cervical SCI. This study will utilize the “networked neuroprosthesis” (NNP). The NNP system is completely implanted...individuals with cervical SCI. We have completed a clinical feasibility study of a neuroprosthesis that provides myoelectrically-controlled hand...by this proposal) cervical level spinal cord injured subjects and evaluate the resulting improvement in upper extremity function. Compare functional

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

PubMed

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

2018-03-01

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

A proposed clinical research support career pathway for noninvestigators.

PubMed

Smith, Sheree; Gullick, Janice; Ballard, Jacqueline; Perry, Lin

2018-06-01

To discuss the international experience of clinical research support for noninvestigator roles and to propose a new pathway for Australia, to promote a sustainable research support workforce capable of delivering high-quality clinical research. Noninvestigator research support roles are currently characterized by an ad hoc approach to training, with limited role delineation and perceived professional isolation with implications for study completion rates and participant safety. A focused approach to developing and implementing research support pathways has improved patient recruitment, study completion, job satisfaction, and research governance. The Queensland and New South Wales state-based Nurses' Awards, the Australian Qualifications Framework, and a University Professional (Research) Staff Award. Research nurses in the clinical environment improve study coordination, adherence to study protocol, patient safety, and clinical care. A career pathway that guides education and outlines position descriptions and skill sets would enhance development of the research support workforce. This pathway could contribute to changing the patient outcomes through coordination and study completion of high-quality research. A wide consultative approach is required to determine a cost-effective and feasible approach to implementation and evaluation of the proposed pathway. © 2018 John Wiley & Sons Australia, Ltd.

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

PubMed

Semenov, V Iu; Samorodskaia, I V

2014-01-01

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

Clinical Presentation of Patients with Symptomatic Anterior Hip Impingement

PubMed Central

Knaus, Evan R.; Hunt, Devyani M.; Lesher, John M.; Harris-Hayes, Marcie; Prather, Heidi

2009-01-01

Femoroacetabular impingement (FAI) is considered a cause of labrochondral disease and secondary osteoarthritis. Nevertheless, the clinical syndrome associated with FAI is not fully characterized. We determined the clinical history, functional status, activity status, and physical examination findings that characterize FAI. We prospectively evaluated 51 patients (52 hips) with symptomatic FAI. Evaluation of the clinical history, physical exam, and previous treatments was performed. Patients completed demographic and validated hip questionnaires (Baecke et al., SF-12, Modified Harris hip, and UCLA activity score). The average patient age was 35 years and 57% were male. Symptom onset was commonly insidious (65%) and activity-related. Pain occurred predominantly in the groin (83%). The mean time from symptom onset to definitive diagnosis was 3.1 years. Patients were evaluated by an average 4.2 healthcare providers prior to diagnosis and inaccurate diagnoses were common. Thirteen percent had unsuccessful surgery at another anatomic site. On exam, 88% of the hips were painful with the anterior impingement test. Hip flexion and internal rotation in flexion were limited to an average 97° and 9°, respectively. The patients were relatively active, yet demonstrated restrictions of function and overall health. These data may facilitate diagnosis of this disorder. Level of Evidence: Level II, diagnostic study. See the Guidelines for Authors for a complete description of levels of evidence. PMID:19130160

Clinical evaluation of a chemomechanical method for caries removal in children and adolescents.

PubMed

Peric, Tamara; Markovic, Dejan; Petrovic, Bojan

2009-01-01

The purpose of this study was to make a clinical comparison of the chemomechanical method for caries removal and the conventional rotary instruments technique when used in children and adolescents. The study comprised 120 patients aged 3-17 years randomized into two groups: caries were removed chemomechanically in 60 patients and 60 patients received conventional treatment with rotary instruments. The outcome variables were: clinically complete caries removal, pain during caries removal, need for local anesthesia, treatment time, preferences of patients, and clinical success of the restorations during the 12-month evaluation period. Complete caries removal was achieved in 92% of chemomechanically treated teeth and in all teeth treated with rotary instruments (p>0.05). The chemomechanical method significantly reduced the need for local anesthesia (p<0.001). Eighty-five percent of patients treated with Carisolv and 47% treated with rotary instruments were satisfied with the treatment (p<0.05). The mean time for chemomechanical caries removal was 11.2 ± 3.3 min and 5.2 ± 2.8 min for caries removal with rotary instruments (p<0.001). At the end of the 12-month evaluation period, there was no observed influence of the caries removal method on the survival of the restorations. The chemomechanical caries removal technique is an adequate alternative to the conventional rotary instruments method and is advantageous in pediatric dentistry.

Evaluation of the efficacy of photodynamic therapy for the treatment of actinic cheilitis.

PubMed

Chaves, Yuri N; Torezan, Luis Antonio; Lourenço, Silvia Vanessa; Neto, Cyro Festa

2017-01-01

Actinic cheilitis (AC) is a lip intraepithelial neoplasia, whose cells present alterations similar to those presented by invasive squamous cell carcinomas (SCCs). To conduct clinical and laboratory evaluation by histopathology and immunohistochemistry of the efficacy of actinic cheilitis treatment using photodynamic therapy (PDT) with methyl aminolevulinate (MAL) and noncoherent red light. Patients with actinic cheilitis detected by histopathological examination were submitted to two sessions of photodynamic therapy with a two-week interval between them. They were examined immediately after the sessions, four, six, and twelve weeks after beginning treatment when a new biopsy was carried out. Clinical histopathological and immunohistochemical parameters were evaluated before and after treatment. Of the 23 patients who underwent biopsy, 16 completed two photodynamic therapy sessions and the material of one patient was insufficient for immunohistochemistry. Complete clinical response was achieved in 62.5% (10 of 16 patients) and 37.5% still remained with clinical evidence of AC. In spite of this, no case of cure by histopathological analysis was found. There was no significant statistical change among the values of Ki-67, survivin, and p53 observed before and after treatment. Photodynamic therapy, as carried out in this trial, was not an efficacious therapeutic option for treating patients with actinic cheilitis included in this sample. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

The Pine Ridge-Mayo National Aeronautics and Space Administration telemedicine project: program activities and participant reactions.

PubMed

Kottke, T E; Little Finger, L; Trapp, M A; Panser, L A; Novotny, P J

1996-04-01

To determine the response of participants to the Pine Ridge-Mayo National Aeronautics and Space Administration telemedicine project. We describe a 3-month demonstration project of medical education and clinical consultations conducted by means of satellite transmission. Postparticipation questionnaires and a postproject survey were used to assess the success of the activity. Patients and employees at the Pine Ridge Indian Health Service Hospital in southwestern South Dakota and employees at Mayo Clinic Rochester participated in a telemedicine project, after which they completed exit surveys and a postproject questionnaire to ascertain the acceptability of this mode of health care. Almost all Pine Ridge and Mayo Clinic participants viewed the project as beneficial. The educational sessions received favorable evaluations, and almost two-thirds of the patients who completed evaluations thought the consultation had contributed to their medical care. More than 90% of the respondents from Pine Ridge and more than 85% of the respondents from Mayo Clinic Rochester said that they would recommend participation in this project to others. More than 90% of respondents from Pine Ridge and 80% of Mayo respondents agreed with the statement that the project should continue. These data suggest that a program of clinical consultation services, professional education, and patient education available by telemedicine might be viewed as beneficial.

Evaluation of the enterovirus laboratory surveillance system in Denmark, 2010 to 2013.

PubMed

Condell, Orla; Midgley, Sofie; Christiansen, Claus Bohn; Chen, Ming; Chen Nielsen, Xiaohui; Ellermann-Eriksen, Svend; Mølvadgaard, Mette; Schønning, Kristian; Vermedal Hoegh, Silje; Andersen, Peter Henrik; Voldstedlund, Marianne; Fischer, Thea Kølsen

2016-05-05

The primary aim of the Danish enterovirus (EV) surveillance system is to document absence of poliovirus infection. The conflict in Syria has left many children unvaccinated and movement from areas with polio cases to Europe calls for increased awareness to detect and respond to virus-transmission in a timely manner. We evaluate the national EV laboratory surveillance, to generate recommendations for system strengthening. The system was analysed for completeness of viral typing analysis and clinical information and timeliness of specimen collection, laboratory results and reporting of clinical information. Of 23,720 specimens screened, 2,202 (9.3%) were EV-positive. Submission of cerebrospinal fluid and faecal specimens from primary diagnostic laboratories was 79.5% complete (845/1,063), and varied by laboratory and patient age. EV genotypes were determined in 68.5% (979/1,430) of laboratory-confirmed cases, clinical information was available for 63.1% (903/1,430). Primary diagnostic results were available after a median of 1.4 days, typing results after 17 days, detailed clinical information after 33 days. The large number of samples typed demonstrated continued monitoring of EV-circulation in Denmark. The system could be strengthened by increasing the collection of supplementary faecal specimens, improving communication with primary diagnostic laboratories, adapting the laboratory typing methodology and collecting clinical information with electronic forms.

A clinical evaluation denture adhesives used by patients with xerostomia.

PubMed

Bogucki, Zdzislaw A; Napadlek, Piotr; Dabrowa, Tomasz

2015-02-01

The purpose of study was to analyze the participants' opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia.

An Inexpensive Family Index of Risk for Mood Issues Improves Identification of Pediatric Bipolar Disorder

PubMed Central

Algorta, Guillermo Perez; Youngstrom, Eric A.; Phelps, James; Jenkins, Melissa M.; Kogos, Jennifer L.; Findling, Robert L.

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient settings. Families (N=273) completed family history, rating scales, MINI and KSADS interviews about youths 5–18 (median=11) years presenting to an outpatient clinic. Primary caregivers completed a half page Family Index of Risk for Mood issues (FIRM). All families completed the FIRM quickly and easily. Most (78%) reported 1+ relatives having history of mood or substance issues, M=3.7 (SD=3.3). A simple sum of familial mood issues discriminated cases with PBD from all other cases, AUROC=.63, p=.006. FIRM scores were specific to youth mood disorder and not ADHD or disruptive behavior disorder. FIRM scores significantly improved the detection of PBD even controlling for rating scales. No subset of family risk items performed better than the total. Family history information showed clinically meaningful discrimination of PBD. Two different approaches to clinical interpretation showed validity in these clinically realistic data. Inexpensive and clinically practical methods of gathering family history can help to improve the detection of PBD. PMID:22800090

Characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov.

PubMed

Stockmann, Chris; Sherwin, Catherine M T; Koren, Gideon; Campbell, Sarah C; Constance, Jonathan E; Linakis, Matthew; Balch, Alfred; Varner, Michael W; Spigarelli, Michael G

2014-04-01

Physiologic changes during pregnancy alter the pharmacokinetics, safety, and efficacy of many drugs. For clinicians, there is often uncertainty regarding the safety of these drugs due to a scarcity of published data. This study aimed to comprehensively evaluate the characteristics and publication patterns of obstetric studies registered in ClinicalTrials.gov from 2007 to 2012. Primary outcome measures, funding sources, inclusion criteria, and the reporting of study results were evaluated. A manual review of Medline/PubMed was performed to identify publications associated with studies registered in ClinicalTrials.gov. Of 93,709 total studies, there were 5,203 (6%) obstetric studies registered in ClinicalTrials.gov. Interventional studies accounted for 70% and 30% were observational. Clinical trials of drugs (49%), procedures (13%), and behavioral interventions (12%) were most common. Among interventional drug trials, 84% featured randomized allocation to study arms and 93% included measures of safety and/or efficacy as primary endpoints. Of 946 (18%) studies completed more than 2 years ago, only 11% had reported results and <7% had been published. In an area with a great need for evidence of safe and effective therapies, the low publication rate of completed studies incorporating elements of high-quality trial design is concerning. The sources of this trend should be closely investigated. © 2013, The American College of Clinical Pharmacology.

Outcome evaluation of Family Eats: An eight-session web-based program promoting healthy home food environments and dietary behaviors for African American families

USDA-ARS?s Scientific Manuscript database

This article presents the results of a randomized clinical trial evaluating the eight-session Family Eats web-based intervention promoting healthy home food environments for African American families. African American families (n=126) with 8- to 12-year-old children completed online baseline questio...

French version of the Copenhagen neck functional disability scale.

PubMed

Forestier, Romain; Françon, Alain; Arroman, Frédérique Saint; Bertolino, Christiane

2007-03-01

We conducted a study to validate the French version of the Copenhagen Neck Functional Disability Scale (CNFDS). We used the CNFDS on data generated by a previous randomized controlled trial comparing pulsed electromagnetic field therapy (PEMFT), spa therapy, and standard therapy in patients with neck pain. Patients were recruited locally and examined by a physician who was unaware of the treatment group and independent from the trial. Treatment efficacy was evaluated based on a visual analog scale (VAS) for pain, the short-form-36 quality-of-life instrument (SF36), payments by public healthcare insurance, and overall assessments by the patients and physicians. Efficacy was evaluated at baseline, at treatment completion, and after 3 and 6 months. In addition, the patients completed the CNFDS at these time points. CNFDS scores were normally distributed. CNFDS scores and their variations correlated well with the other efficacy criteria. CNFDS scores were less sensitive to change than the VAS pain scores and more sensitive to change than the other efficacy criteria. The CNFDS holds promise as a tool for evaluating neck pain. Score reproducibility needs to be studied. The CNFDS can be added to the other instruments that have been translated in recent years to serve as tools for clinical research. However, the ease of completion of the CNFDS is consistent with use in clinical practice.

Efficacy of print advertising for a bipolar disorder study.

PubMed

Roy, Sumeet; Patel, Shilpa; Sheehan, Kathy Harnett; Janavs, Juris; Sheehan, David

2008-01-01

Using quality and quantity of responses, this study evaluated the efficacy of advertising in print media for a bipolar disorder clinical trial. We analyzed the corresponding quantity of calls generated and the cost per patient yield at each of the standard study milestones, spending on print advertising. Quality of calls was based on the attrition rates at each of the study stages. Five hundred and twenty-six calls were received over a 28-month period (February 2004 to June 2006). The largest number of calls were received early in the week (Monday, 25.6%; Tuesday, 23.5%; Wednesday, 18.8%), corresponding with increased advertisements toward the end of the previous week. From the total calls received, 17.14% were eligible for a screening visit, 10.28% were randomized, 9.14% were evaluable, and 7% completed the 8-week study. Sixty percent of the subjects who attended the screening visit were randomized and 68.5% of the randomized subjects completed the study. The yield from phone calls responding to print advertising for a bipolar disorder study was 7%, costing $1,330 per evaluable subject and $1,725 per completed subject. These figures may be useful benchmarks in recruitment planning and budgeting for participants in clinical trials on bipolar disorder.

Integrating 3D facial scanning in a digital workflow to CAD/CAM design and fabricate complete dentures for immediate total mouth rehabilitation

PubMed Central

Greven, Marcus; Wismeijer, Daniel

2017-01-01

PURPOSE To integrate extra-oral facial scanning information with CAD/CAM complete dentures to immediately rehabilitate terminal dentition. MATERIALS AND METHODS Ten patients with terminal dentition scheduled for total extraction and immediate denture placement were recruited for this study. The patients were submitted to a facial scanning procedure using the in-office PritiMirror scanner with bite registration records in-situ. Definitive stone cast models and bite records were subsequently submitted to a lab scanning procedure using the lab scanner (iSeries DWOS; Dental Wings). The scanned models were used to create a virtual teeth setup of a complete denture. Using the intra-oral bite records as a reference, the virtual setup was incorporated in the facial scan thereby facilitating a virtual clinical evaluation (teeth try-in) phase. After applying necessary adjustments, the virtual setup was submitted to a CAM procedure where a 5-axis industrial milling machine (M7 CNC; Darton AG General) was used to fabricate a full-milled PMMA immediate provisional prosthesis. RESULTS Total extractions were performed, the dentures were immediately inserted, and subjective clinical fit was evaluated. The immediate provisional prostheses were inserted and clinical fit, occlusion/articulation, and esthetics were subjectively assessed; the results were deemed satisfactory. All provisional prostheses remained three months in function with no notable technical complications. CONCLUSION Ten patients with terminal dentition were treated using a complete digital approach to fabricate complete dentures using CAD/CAM technology. The proposed technique has the potential to accelerate the rehabilitation procedure starting from immediate denture to final implant-supported prosthesis leading to more predictable functional and aesthetics outcomes. PMID:29142646

Why do women not return family history forms when referred to breast cancer genetics services? A mixed-method study.

PubMed

Hanning, Kirstie A; Steel, Michael; Goudie, David; McLeish, Lorna; Dunlop, Jackie; Myring, Jessica; Sullivan, Frank; Berg, Jonathan; Humphris, Gerry; Ozakinci, Gozde

2015-10-01

Personal and family data forms, completed by women referred to breast cancer genetics clinics, are valuable tools for verification and extension of family history, crucial steps in accurate risk evaluation. A significant minority of women do not complete and return these forms, despite reminders, even when completion is a pre-requisite for a clinic appointment. To facilitate access of women at increased familial risk of breast cancer to screening and counselling services by investigating reasons for non-return of the forms. Based on a single regional 'breast cancer family' service in the UK, Analysis of quantitative data comparing women who did not return forms (n = 55) with those who had done so (n = 59), together with qualitative evaluation of potential barriers to form-completion through semi-structured telephone interviews with a random subset of 'non-returners' (n = 23). Non-returners have higher proportions of the very young (below the age at which surveillance could be offered) and of women from lower social deprivation categories. Interviews revealed that the majority of non-returners are anxious, rather than unconcerned about their breast cancer risk and circumstances and attitudes contributed to non-compliance. Twenty-one participants confirmed that they would welcome an appointment at a 'breast cancer family' clinic, but nine did not attend for the appointment. They were significantly younger than those who attend, but were not at lower familial risk. Many women who fail to complete and return a family history form would benefit from risk assessment and genetic counselling. Several steps are suggested that might help them access the relevant services. © 2014 John Wiley & Sons Ltd.

A novel complete-case analysis to determine statistical significance between treatments in an intention-to-treat population of randomized clinical trials involving missing data.

PubMed

Liu, Wei; Ding, Jinhui

2018-04-01

The application of the principle of the intention-to-treat (ITT) to the analysis of clinical trials is challenged in the presence of missing outcome data. The consequences of stopping an assigned treatment in a withdrawn subject are unknown. It is difficult to make a single assumption about missing mechanisms for all clinical trials because there are complicated reactions in the human body to drugs due to the presence of complex biological networks, leading to data missing randomly or non-randomly. Currently there is no statistical method that can tell whether a difference between two treatments in the ITT population of a randomized clinical trial with missing data is significant at a pre-specified level. Making no assumptions about the missing mechanisms, we propose a generalized complete-case (GCC) analysis based on the data of completers. An evaluation of the impact of missing data on the ITT analysis reveals that a statistically significant GCC result implies a significant treatment effect in the ITT population at a pre-specified significance level unless, relative to the comparator, the test drug is poisonous to the non-completers as documented in their medical records. Applications of the GCC analysis are illustrated using literature data, and its properties and limits are discussed.

The development of a community and home-based chronic care management program for older adults.

PubMed

Cooper, Jennifer; McCarter, Kathryn A

2014-01-01

The objective of this paper was to evaluate a chronic care management program piloted by a visiting nurses association. Desired outcomes were to increase nurses' knowledge of self-management of chronic conditions and improve patient self-efficacy and clinical measures. The program provided educational development for nurses and piloted encounters with patients with chronic conditions targeting community health nurses for a chronic care professional (CCP) certification and invited 300 faith community nurses to an education program on chronic condition(s). Thirteen patients with chronic condition(s) were enrolled. Chronic care professional modules were used to increase nurses' knowledge and were measured by successful completion of a certification exam. Faith community nurses participated in an education program and completed a posttest to measure knowledge of content. Patient improvement in self-management was measured by pre- and postintervention self-efficacy scores and clinical measures. Seventeen nurses successfully completed the exam, and 38 faith community nurses participated in the program and completed the posttest. Three patients showed improvement in self-efficacy scores and eight in clinical measures. The educational development of community nurses prepared them to provide effective encounters to improve self-efficacy and clinical outcomes for older adults with chronic conditions. © 2013 Wiley Periodicals, Inc.

Joint breast and colorectal cancer screenings in medically underserved women

PubMed Central

Davis, Terry C; Arnold, Connie L; Wolf, Michael S; Bennett, Charles L; Liu, Dachao; Rademaker, Alfred

2016-01-01

Background Breast and colon cancer screening in rural community clinics is underused. Objective To evaluate the effectiveness and cost-effectiveness of alternative interventions designed to promote simultaneous screening for breast and colon cancer in community clinics. Methods A 3-arm, quasi-experimental evaluation was conducted during May 2008-August 2011 in 8 federally qualifed health clinics in predominately rural Louisiana. Baseline screening rates reported by the clinics was <10% for breast cancer (using mammography) and 1%-2% for colon cancer (using the fecal occult blood test [FOBT]). 744 women aged 50 years or older who were eligible for routine mammography and an FOBT were recruited. The combined screening efforts included: enhanced care; health literacy-informed education (education alone), or health literacy-informed education with nurse support (nurse support). Results Postintervention screening rates for completing both tests were 28.1% with enhanced care, 23.7% with education alone, and 38.7% with nurse support. After adjusting for age, race, and literacy, patients who received nurse support were 2.21 times more likely to complete both screenings than were those who received the education alone (95% confidence interval [CI], 1.12-4.38; P = .023). The incremental cost per additional woman completing both screenings was $3,987 for education with nurse support over education alone, and $5,987 over enhanced care. Limitations There were differences between the 3 arms in sociodemographic characteristics, literacy, and previous screening history. Not all variables that were significantly different between arms were adjusted for, therefore adjustments for key variables (age, race, literacy) were made in statistical analyses. Other limitations related generalizability of results. Conclusions Although joint breast and colon cancer screening rates were increased substantially over existing baseline rates in all 3 arms, the completion rate for both tests was modest. Nurse support and telephone follow-up were most effective. However, it is not likely to be cost effective or affordable in clinics with limited resources. PMID:26918252

Evaluating online diagnostic decision support tools for the clinical setting.

PubMed

Pryor, Marie; White, David; Potter, Bronwyn; Traill, Roger

2012-01-01

Clinical decision support tools available at the point of care are an effective adjunct to support clinicians to make clinical decisions and improve patient outcomes. We developed a methodology and applied it to evaluate commercially available online clinical diagnostic decision support (DDS) tools for use at the point of care. We identified 11 commercially available DDS tools and assessed these against an evaluation instrument that included 6 categories; general information, content, quality control, search, clinical results and other features. We developed diagnostically challenging clinical case scenarios based on real patient experience that were commonly missed by junior medical staff. The evaluation was divided into 2 phases; an initial evaluation of all identified and accessible DDS tools conducted by the Clinical Information Access Portal (CIAP) team and a second phase that further assessed the top 3 tools identified in the initial evaluation phase. An evaluation panel consisting of senior and junior medical clinicians from NSW Health conducted the second phase. Of the eleven tools that were assessed against the evaluation instrument only 4 tools completely met the DDS definition that was adopted for this evaluation and were able to produce a differential diagnosis. From the initial phase of the evaluation 4 DDS tools scored 70% or more (maximum score 96%) for the content category, 8 tools scored 65% or more (maximum 100%) for the quality control category, 5 tools scored 65% or more (maximum 94%) for the search category, and 4 tools score 70% or more (maximum 81%) for the clinical results category. The second phase of the evaluation was focused on assessing diagnostic accuracy for the top 3 tools identified in the initial phase. Best Practice ranked highest overall against the 6 clinical case scenarios used. Overall the differentiating factor between the top 3 DDS tools was determined by diagnostic accuracy ranking, ease of use and the confidence and credibility of the clinical information. The evaluation methodology used here to assess the quality and comprehensiveness of clinical DDS tools was effective in identifying the most appropriate tool for the clinical setting. The use of clinical case scenarios is fundamental in determining the diagnostic accuracy and usability of the tools.

The fate of prospective spine studies registered on www.ClinicalTrials.gov.

PubMed

Ohnmeiss, Donna D

2015-03-01

There has been concern expressed about research ethics with respect to not fully reporting data collected during clinical studies. One site available for all clinical trials is ClinicalTrials.gov. The original purpose of this site was to facilitate patients seeking a trial for the treatment of their particular condition. The internationally available site offers general information about the study, sponsor name, principal investigator, patient selection criteria, enrollment goal, study design, outcome measures, participating centers, initiation date, date posted, date completed, and other pertinent data. The site can be used to identify studies conducted for a particular condition or intervention. The purpose of this study was to investigate the fate of spine-related studies registered on www.ClinicalTrials.gov, with particular focus on the publication rate of completed trials. Analysis and classification of clinical studies posted on an international research registry Web page and literature search for related publications. Not applicable. The primary outcome measure was publication of the study registered on ClinicalTrials.gov. Multiple searches were conducted on ClinicalTrials.gov Web site to identify studies related to commonly treated spinal conditions, including herniated disc, degenerative disc disease, stenosis, and spondylolisthesis. Studies related to tumors, fractures, or that included nonspine conditions were not included. For studies classified as completed more than 18 months before this review, literature searches were conducted to determine if the results of the study had been published and factors related to publication. The author has no financial conflict related to this work. There were 263 spine-related studies identified from searches on the ClinicalTrials.gov site. Data on the site had the studies classified as follows: 72 completed, 70 active, not recruiting (generally indicates collecting follow-up data), 74 recruiting, 11 recruiting by invitation, 13 not yet recruiting, 18 terminated, 4 withdrawn, and 1 suspended. Among the 72 studies indicated to be completed, 28 (38.9%) have been published. The mean time to publish was 27.9 months from the date of completion. Among unpublished studies, the mean length of time from study completion to the preparation of this article was 62.0 months. There was no difference in the likelihood of publication based on the geographic region of study origin or whether the study was registered before or after initiation. There were statistically significant relationships between the publication rate and the funding type as well as the research type (p<.05) with industrial-funded studies and those evaluating devices having a lower publication rate and those that were funded by a federal agency and comparing surgery to nonoperative care had the highest publication rates. Although the 38.9% publication rate for spine-related studies found in this study appears low, it is in line with other studies reporting a 22.8% publication rate for arthroplasty trials and 43.2% for orthopedic trauma trials. In addition to ClinicalTrials.gov Web site fulfilling its original goal of providing patients information about clinical studies, it can also provide a means of tracking publication of prospective studies, changes to protocols, matching publication content to posted study design, and others and raise queries concerning the reasons for not publishing what appear to be well-designed studies. The posting of spine studies before initiation can increase transparency and ability to evaluate clinical trials in spine. Copyright © 2015 Elsevier Inc. All rights reserved.

A randomized, multicenter, double-blind, vehicle-controlled study evaluating the efficacy and safety of luliconazole cream 1% once daily for 7 days in patients aged ≥ 12 years with tinea cruris.

PubMed

Jones, Terry M; Jarratt, Michael T; Mendez-Moguel, Ines; Paz, Nelly; Grekin, Steven K; Cognata Smith, Christina; Kaur, Mandeep

2014-01-01

Tinea cruris, a pruritic superficial fungal infection of the groin, is the second most common clinical presentation for dermatophytosis. This phase 3 study evaluated the safety and efficacy of topical luliconazole cream 1% in patients with tinea cruris. 483 patients were enrolled and 256 male and female patients aged ≥12 years with clinically evident tinea cruris and eligible for modified intent-to-treat analysis were randomized 2:1 to receive luliconazole cream 1% (n=165) or vehicle (n=91) once daily for 7 days. Efficacy was evaluated at baseline and at days 7, 14, 21, and 28 based on mycology (potassium hydroxide, fungal culture) and clinical signs (erythema, scaling, pruritus). The primary outcome was complete clearance at day 28 (21 days posttreatment). Safety evaluations included adverse events and laboratory assessments. Complete clearance was obtained in 21.2% (35/165) of patients treated with luliconazole cream 1% compared with 4.4% (4/91) treated with vehicle (P<0.001). The safety profile of luliconazole cream 1% was similar to vehicle. The study was conducted under controlled conditions in a relatively small population. Luliconazole cream 1% applied once daily for 7 days is more effective than vehicle and well tolerated in patients with tinea cruris.

Proof of Learning Outcome by the Advanced Clinical Competency Examination Trial after the Long-term Student's Practice in Pharmaceutical Education.

PubMed

Komori, Koji; Kataoka, Makoto; Kuramoto, Nobuyuki; Tsuji, Takumi; Nakatani, Takafumi; Yasuhara, Tomohisa; Mitamura, Shinobu; Hane, Yumiko; Ogita, Kiyokazu

2016-01-01

At Setsunan University, a debrief session (a poster session) is commonly performed by the students who have completed the long-term students' practice. Since the valuable changes in practical competency of the students cannot be evaluated through this session, we specified items that can help evaluate and methods that can help estimate the students' competency as clinical pharmacists. We subsequently carried out a trial called the "Advanced Clinical Competency Examination". We evaluated 103 students who had concluded the students' practice for the second period (Sep 1, 2014, to Nov 16, 2014): 70 students (called "All finish students") who had completed the practice in a hospital and pharmacy, and 33 students (called "Hospital finish students") who had finished the practice at a hospital only. The trial was executed in four stages. In the first stage, students drew pictures of something impressive they had learned during the practice. In the second stage, students were given patient cases and were asked, "What is this patient's problem?" and "How would you solve this problem?". In the third stage, the students discussed their answers in a group. In the fourth stage, each group made a poster presentation in separate rooms. By using a rubric, the teachers evaluated each student individually, the results of which showed that the "All finish students" could identify more problems than the "Hospital finish students".

The Clinical Quality Fellowship Program: Developing Clinical Quality Leadership in the Greater New York Region.

PubMed

Bhalla, Rohit; Jalon, Hillary S; Ryan, Lorraine

The Institute of Medicine has noted that a key factor underlying patient safety problems in the United States is a paucity of quality and safety training programs for clinicians. The Greater New York Hospital Association and United Hospital Fund created the Clinical Quality Fellowship Program (CQFP) to develop quality improvement leaders in the New York region. The goals of this article are to describe the CQFP's structure and curriculum, program participants' perceived value, improvement projects, and career paths. Eighty-seven participants completed the CQFP from 2010 to 2014. Among program participants completing self-assessment evaluations, significant improvements were observed across all quality improvement skill areas. Capstone project categories included inpatient efficiency, transitional care, and hospital infection. Fifty-six percent of participants obtained promotions following program completion. A training program emphasizing diverse curricular elements, varied learning approaches, and applied improvement projects increased participants' self-perceived skills, generated diverse improvement initiatives, and was associated with career advancement.

Clinical trials transparency and the Trial and Experimental Studies Transparency (TEST) act.

PubMed

Logvinov, Ilana

2014-03-01

Clinical trial research is the cornerstone for successful advancement of medicine that provides hope for millions of people in the future. Full transparency in clinical trials may allow independent investigators to evaluate study designs, perform additional analysis of data, and potentially eliminate duplicate studies. Current regulatory system and publishers rely on investigators and pharmaceutical industries for complete and accurate reporting of results from completed clinical trials. Legislation seems to be the only way to enforce mandatory disclosure of results. The Trial and Experimental Studies Transparency (TEST) Act of 2012 was introduced to the legislators in the United States to promote greater transparency in research industry. Public safety and advancement of science are the driving forces for the proposed policy change. The TEST Act may benefit the society and researchers; however, there are major concerns with participants' privacy and intellectual property protection. Copyright © 2014 Elsevier Inc. All rights reserved.

Evidence-Based Parenting Interventions to Promote Secure Attachment

PubMed Central

Wright, Barry; Edginton, Elizabeth

2016-01-01

Various interventions are used in clinical practice to address insecure or disorganized attachment patterns and attachment disorders. The most common of these are parenting interventions, but not all have a robust empirical evidence base. We undertook a systematic review of randomized trials comparing a parenting intervention with a control, where these used a validated attachment instrument, in order to evaluate the clinical and cost-effectiveness of interventions aiming to improve attachment in children with severe attachment problems (mean age <13 years). This article aims to inform clinicians about the parenting interventions included in our systematic review that were clinically effective in promoting secure attachment. For completeness, we also briefly discuss other interventions without randomized controlled trial evidence, identified in Patient Public Involvement workshops and expert groups at the point our review was completed as being used or recommended. We outline the key implications of our findings for clinical practice and future research. PMID:27583298

Comparison between student rating, faculty self-rating and evaluation of faculty members by heads of respective academic departments in the school of medicine in Birjand University of Medical Sciences in Iran.

PubMed

Taheri, Mohammad Mehdi Hassanzadeh; Ryasi, Hamid Reza; Afshar, Mohammad; Mofatteh, Mohammad Reza

2014-01-01

University teachers are one of the main pillars of university and the quality of their performance must continuously and systematically be evaluated. This evaluation can be carried out in various ways. The aim of the present study was to survey and to compare the evaluation of faculty members in the medical school in Birjand University of Medical Sciences by three different sources: Student rating, self-assessment, and evaluation by head of related department. This descriptive analytical cross-sectional study was conducted in the academic year 2009-2010. Sampling was drawn from all students studying basic science and clinical training in the first and the second semesters. All heads of departments in basic science and clinical training and their faculty members took part in this study. Means of data collection were four different questionnaires designed in the education development center (EDC) and their validity and reliability had been verified by the center. These questionnaires were based on student rating, self-assessment, and evaluation of faculty members by heads of clinical and basic sciences academic departments. After the questionnaires were filled out, the obtained data was analyzed by Statistical Package for the Social Sciences (SPSS) software (version 13), independent t-test, and Pearson's correlation coefficient at the significant level of α = 0.05. In the present study, 2417 students completed the questionnaires regarding 63 faculty members, 87 faculty members completed the self-assessment form, and for 60 faculty members, 48 members in clinical and 12 members in basic science, the questionnaires were completed by heads of respective departments. Mean and standard deviation of student evaluation, self-assessment, and teachers evaluation by heads of departments were 3.23 ± 0.38, 3.51 ± 0.33, and 3.60 ± 0.32, respectively, and the difference between student rating and self-assessment was significant (P = 0.02). In comparing between managers scores with students evaluation, no significant difference was observed (P = 0.68). Comparison between self-assessment and teachers scores by managers showed a significant difference (P = 0.04). Mean scores of faculty members in clinical training and in basic science were 3.23 ± 0.73 and 3.31 ± 0.69 on the part of students, respectively; thus, the difference was significant (P = 0.004). Since, the present study was inconsistent with similar previously carried out investigations, the observed difference among the three procedures was statically significant; hence, it can be suggested that student's scores of teachers evaluation, previously used as the only one of evaluation source is not enough and other sources such as assessment by the respective department heads, dean of faculty, and self-assessment must also be taken into consideration. This collection can definitely yield a more favorable evaluation of faculty members and feedback can be more acceptable to them and it will be more effective in improving their education.

Influence of form structure on the anesthesia preoperative evaluation.

PubMed

Marco, Alan P; Buchman, Debra; Lancz, Colleen

2003-09-01

To determine the impact of changes in form design on the capture of administrative and clinical data elements. Randomized retrospective chart review. Academic health center. Patients undergoing surgical procedures in the operating rooms at Medical College Hospital. The principal intervention was the implementation of a newly designed anesthesiology preoperative evaluation form with the intent to improve data capture. Charts were reviewed for the presence or absence of the following indicators: Addressograph Stamp, Proposed Surgery, Current Medications, Medication Doses/Frequency, Allergies, ASA Physical Status, Anesthesia Plan, Attending Note, and fasting (NPO) Status. Completion of Proposed Surgery and ASA Physical Status was lower for the structured form. Completion of Attending Notes was higher with the new form. Medication Doses were more often completed, but they remained below desired levels on the new form. Design of a form can have a significant impact on the completion rate of form elements. Visual cues such as a labeled space for medication doses may improve the completion of these elements. Design layout can also have an influence on completion. In this case, changes to the layout may have impeded the completion rate for ASA Physical Status.

Evaluation of user interface and workflow design of a bedside nursing clinical decision support system.

PubMed

Yuan, Michael Juntao; Finley, George Mike; Long, Ju; Mills, Christy; Johnson, Ron Kim

2013-01-31

Clinical decision support systems (CDSS) are important tools to improve health care outcomes and reduce preventable medical adverse events. However, the effectiveness and success of CDSS depend on their implementation context and usability in complex health care settings. As a result, usability design and validation, especially in real world clinical settings, are crucial aspects of successful CDSS implementations. Our objective was to develop a novel CDSS to help frontline nurses better manage critical symptom changes in hospitalized patients, hence reducing preventable failure to rescue cases. A robust user interface and implementation strategy that fit into existing workflows was key for the success of the CDSS. Guided by a formal usability evaluation framework, UFuRT (user, function, representation, and task analysis), we developed a high-level specification of the product that captures key usability requirements and is flexible to implement. We interviewed users of the proposed CDSS to identify requirements, listed functions, and operations the system must perform. We then designed visual and workflow representations of the product to perform the operations. The user interface and workflow design were evaluated via heuristic and end user performance evaluation. The heuristic evaluation was done after the first prototype, and its results were incorporated into the product before the end user evaluation was conducted. First, we recruited 4 evaluators with strong domain expertise to study the initial prototype. Heuristic violations were coded and rated for severity. Second, after development of the system, we assembled a panel of nurses, consisting of 3 licensed vocational nurses and 7 registered nurses, to evaluate the user interface and workflow via simulated use cases. We recorded whether each session was successfully completed and its completion time. Each nurse was asked to use the National Aeronautics and Space Administration (NASA) Task Load Index to self-evaluate the amount of cognitive and physical burden associated with using the device. A total of 83 heuristic violations were identified in the studies. The distribution of the heuristic violations and their average severity are reported. The nurse evaluators successfully completed all 30 sessions of the performance evaluations. All nurses were able to use the device after a single training session. On average, the nurses took 111 seconds (SD 30 seconds) to complete the simulated task. The NASA Task Load Index results indicated that the work overhead on the nurses was low. In fact, most of the burden measures were consistent with zero. The only potentially significant burden was temporal demand, which was consistent with the primary use case of the tool. The evaluation has shown that our design was functional and met the requirements demanded by the nurses' tight schedules and heavy workloads. The user interface embedded in the tool provided compelling utility to the nurse with minimal distraction.

Limited utility of routine surveillance imaging for classical Hodgkin lymphoma patients in first complete remission.

PubMed

Pingali, Sai Ravi; Jewell, Sarah W; Havlat, Luiza; Bast, Martin A; Thompson, Jonathan R; Eastwood, Daniel C; Bartlett, Nancy L; Armitage, James O; Wagner-Johnston, Nina D; Vose, Julie M; Fenske, Timothy S

2014-07-15

The objective of this study was to compare the outcomes of patients with classical Hodgkin lymphoma (cHL) who achieved complete remission with frontline therapy and then underwent either clinical surveillance or routine surveillance imaging. In total, 241 patients who were newly diagnosed with cHL between January 2000 and December 2010 at 3 participating tertiary care centers and achieved complete remission after first-line therapy were retrospectively analyzed. Of these, there were 174 patients in the routine surveillance imaging group and 67 patients in the clinical surveillance group, based on the intended mode of surveillance. In the routine surveillance imaging group, the intended plan of surveillance included computed tomography and/or positron emission tomography scans; whereas, in the clinical surveillance group, the intended plan of surveillance was clinical examination and laboratory studies, and scans were obtained only to evaluate concerning signs or symptoms. Baseline patient characteristics, prognostic features, treatment records, and outcomes were collected. The primary objective was to compare overall survival for patients in both groups. For secondary objectives, we compared the success of second-line therapy and estimated the costs of imaging for each group. After 5 years of follow-up, the overall survival rate was 97% (95% confidence interval, 92%-99%) in the routine surveillance imaging group and 96% (95% confidence interval, 87%-99%) in the clinical surveillance group (P = .41). There were few relapses in each group, and all patients who relapsed in both groups achieved complete remission with second-line therapy. The charges associated with routine surveillance imaging were significantly higher than those for the clinical surveillance strategy, with no apparent clinical benefit. Clinical surveillance was not inferior to routine surveillance imaging in patients with cHL who achieved complete remission with frontline therapy. Routine surveillance imaging was associated with significantly increased estimated imaging charges. © 2014 American Cancer Society.

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

PubMed

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

2008-06-01

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

A pilot registry of unexplained fatiguing illnesses and chronic fatigue syndrome

PubMed Central

2013-01-01

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

Feasibility of an Electronic Survey on iPads with In-Person Data Collectors for Data Collection with Health Care Professionals and Health Care Consumers in General Emergency Departments.

PubMed

Scott, Shannon D; Albrecht, Lauren; Given, Lisa M; Arseneau, Danielle; Klassen, Terry P

2016-06-29

Translating Emergency Knowledge for Kids was established to bridge the research-practice gap in pediatric emergency care by bringing the best evidence to Canadian general emergency departments (EDs). The first step in this process was to conduct a national needs assessment to determine the information needs and preferences of health professionals and parents in this clinical setting. To describe the development and implementation of two electronic surveys, and determine the feasibility of collecting electronic survey data on iPads with in-person data collectors in a busy clinical environment. Two descriptive surveys were conducted in 32 general EDs. Specific factors were addressed in four survey development and implementation stages: survey design, survey delivery, survey completion, and survey return. Feasibility of the data collection approach was determined by evaluating participation rates, completion rates, average survey time to completion, and usability of the platform. Usability was assessed with the in-person data collectors on five key variables: interactivity, portability, innovativeness, security, and proficiency. Health professional participation rates (1561/2575, 60.62%) and completion rates (1471/1561, 94.23%) were strong. Parental participation rates (974/1099, 88.63%) and completion rates (897/974, 92.09%) were excellent. Mean time to survey completion was 28.08 minutes for health professionals and 43.23 minutes for parents. Data collectors rated the platform "positively" to "very positively" on all five usability variables. A number of design and implementation considerations were explored and integrated into this mixed-mode survey data collection approach. Feasibility was demonstrated by the robust survey participation and completion rates, reasonable survey completion times, and very positive usability evaluation results.

Impact of a brief addiction medicine training experience on knowledge self-assessment among medical learners.

PubMed

Klimas, Jan; Ahamad, Keith; Fairgrieve, Christoper; McLean, Mark; Mead, Annabel; Nolan, Seonaid; Wood, Evan

2017-01-01

Implementation of evidence-based approaches to the treatment of various substance use disorders is needed to tackle the existing epidemic of substance use and related harms. Most clinicians, however, lack knowledge and practical experience with these approaches. Given this deficit, the authors examined the impact of an inpatient elective in addiction medicine amongst medical trainees on addiction-related knowledge and medical management. Trainees who completed an elective with a hospital-based Addiction Medicine Consult Team (AMCT) in Vancouver, Canada, from May 2015 to May 2016, completed a 9-item self-evaluation scale before and immediately after the elective. A total of 48 participants completed both pre and post AMCT elective surveys. On average, participants were 28 years old (interquartile range [IQR] = 27-29) and contributed 20 days (IQR = 13-27) of clinical service. Knowledge of addiction medicine increased significantly post elective (mean difference [MD] = 8.63, standard deviation [SD] = 18.44; P = .002). The most and the least improved areas of knowledge were relapse prevention and substance use screening, respectively. Completion of a clinical elective with a hospital-based AMCT appears to improve medical trainees' addiction-related knowledge. Further evaluation and expansion of addiction medicine education is warranted to develop the next generation of skilled addiction care providers.

Development of a Research Participants’ Perception Survey to Improve Clinical Research

PubMed Central

Yessis, Jennifer L.; Kost, Rhonda G.; Lee, Laura M.; Coller, Barry S.; Henderson, David K.

2012-01-01

Abstract Introduction: Clinical research participants’ perceptions regarding their experiences during research protocols provide outcome‐based insights into the effectiveness of efforts to protect rights and safety, and opportunities to enhance participants’ clinical research experiences. Use of validated surveys measuring patient‐centered outcomes is standard in hospitals, yet no instruments exist to assess outcomes of clinical research processes. Methods: We derived survey questions from data obtained from focus groups comprised of research participants and professionals. We assessed the survey for face/content validity, and privacy/confidentiality protections and fielded it to research participants at 15 centers. We conducted analyses of response rates, sample characteristics, and psychometrics, including survey and item completion and analysis, internal consistency, item internal consistency, criterion‐related validity, and item usefulness. Responses were tested for fit into existing patient‐centered dimensions of care and new clinical research dimensions using Cronbach's alpha coefficient. Results: Surveys were mailed to 18,890 individuals; 4,961 were returned (29%). Survey completion was 89% overall; completion rates exceeded 90% for 88 of 93 evaluable items. Questions fit into three dimensions of patient‐centered care and two novel clinical research dimensions (Cronbach's alpha for dimensions: 0.69–0.85). Conclusions: The validated survey offers a new method for assessing and improving outcomes of clinical research processes. Clin Trans Sci 2012; Volume 5: 452–460 PMID:23253666

Health worker perspectives on barriers to delivery of routine tuberculosis diagnostic evaluation services in Uganda: a qualitative study to guide clinic-based interventions.

PubMed

Cattamanchi, Adithya; Miller, Cecily R; Tapley, Asa; Haguma, Priscilla; Ochom, Emmanuel; Ackerman, Sara; Davis, J Lucian; Katamba, Achilles; Handley, Margaret A

2015-01-22

Studies of the quality of tuberculosis (TB) diagnostic evaluation of patients in high burden countries have generally shown poor adherence to international or national guidelines. Health worker perspectives on barriers to improving TB diagnostic evaluation are critical for developing clinic-level interventions to improve guideline implementation. We conducted structured, in-depth interviews with staff at six district-level health centers in Uganda to elicit their perceptions regarding barriers to TB evaluation. Interviews were transcribed, coded with a standardized framework, and analyzed to identify emergent themes. We used thematic analysis to develop a logic model depicting health system and contextual barriers to recommended TB evaluation practices. To identify possible clinic-level interventions to improve TB evaluation, we categorized findings into predisposing, enabling, and reinforcing factors as described by the PRECEDE model, focusing on potentially modifiable behaviors at the clinic-level. We interviewed 22 health center staff between February 2010 and November 2011. Participants identified key health system barriers hindering TB evaluation, including: stock-outs of drugs/supplies, inadequate space and infrastructure, lack of training, high workload, low staff motivation, and poor coordination of health center services. Contextual barrier challenges to TB evaluation were also reported, including the time and costs borne by patients to seek and complete TB evaluation, poor health literacy, and stigma against patients with TB. These contextual barriers interacted with health system barriers to contribute to sub-standard TB evaluation. Examples of intervention strategies that could address these barriers and are related to PRECEDE model components include: assigned mentors/peer coaching for new staff (targets predisposing factor of low motivation and need for support to conduct job duties); facilitated workshops to implement same day microscopy (targets enabling factor of patient barriers to completing TB evaluation), and recognition/incentives for good TB screening practices (targets low motivation and self-efficacy). Our findings suggest that health system and contextual barriers work together to impede TB diagnosis at health centers and, if not addressed, could hinder TB case detection efforts. Qualitative research that improves understanding of the barriers facing TB providers is critical to developing targeted interventions to improve TB care.

A usability evaluation of four commercial dental computer-based patient record systems

PubMed Central

Thyvalikakath, Thankam P.; Monaco, Valerie; Thambuganipalle, Hima Bindu; Schleyer, Titus

2008-01-01

Background The usability of dental computer-based patient record (CPR) systems has not been studied, despite early evidence that poor usability is a problem for dental CPR system users at multiple levels. Methods The authors conducted formal usability tests of four dental CPR systems by using a purposive sample of four groups of five novice users. The authors measured task outcomes (correctly completed, incorrectly completed and incomplete) in each CPR system while the participants performed nine clinical documentation tasks, as well as the number of usability problems identified in each CPR system and their potential relationship to task outcomes. The authors reviewed the software application design aspects responsible for these usability problems. Results The range for correctly completed tasks was 16 to 64 percent, for incorrectly completed tasks 18 to 38 percent and for incomplete tasks 9 to 47 percent. The authors identified 286 usability problems. The main types were three unsuccessful attempts, negative affect and task incorrectly completed. They also identified six problematic interface and interaction designs that led to usability problems. Conclusion The four dental CPR systems studied have significant usability problems for novice users, resulting in a steep learning curve and potentially reduced system adoption. Clinical Implications The significant number of data entry errors raises concerns about the quality of documentation in clinical practice. PMID:19047669

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

PubMed

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

2018-01-01

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

Efficacy and safety of once-daily luliconazole 1% cream in patients ≥12 years of age with interdigital tinea pedis: a phase 3, randomized, double-blind,vehicle-controlled study.

PubMed

Jarratt, Michael; Jones, Terry; Adelglass, Jeffrey; Bucko, Alicia; Pollak, Richard; Roman-Miranda, Amaury; Olin, Jason T; Swinyer, Leonard

2014-07-01

Interdigital tinea pedis is one of the most common clinical presentations of dermatophytosis. This phase 3 study evaluated the safety and efficacy of luliconazole cream 1% in patients with tinea pedis. A total of 321 male and female patients aged ≥12 years with tinea pedis and eligible for modified intent-to-treat analysis were randomized 1:1 to receive luliconazole cream 1% (n=159) or vehicle (n=162) once daily for 14 days. Efficacy was evaluated at days 28 and 42 (i.e., days 14 and 28 posttreatment) based on clinical signs (erythema, scaling, pruritus) and mycology (KOH, fungal culture). The primary outcome was complete clearance at day 42. Safety evaluations included adverse events and laboratory assessments. Complete clearance at day 42 was achieved in 26.4% (28/106) of patients treated with luliconazole cream 1% compared with 1.9% (2/103) of patients treated with vehicle (P< 0.001). Similar safety profiles were obtained for luliconazole cream 1% and vehicle. This study was conducted in a relatively small population under controlled clinical trial conditions. Luliconazole cream 1% applied once daily for 14 days is well tolerated and more effective than vehicle in patients with tinea pedis.

Developing a useful, user-friendly website for cancer patient follow-up: users' perspectives on ease of access and usefulness.

PubMed

Bartlett, Y K; Selby, D L; Newsham, A; Keding, A; Forman, D; Brown, J; Velikova, G; Wright, P

2012-11-01

UK cancer survival has improved, leading to an increase in review patients and pressure on clinics. Use of the Internet for information exchange between patients and healthcare staff may provide a useful adjunct or alternative to traditional follow-up. This study aimed to develop and evaluate a website for use in follow-up cancer care in terms of usability, feasibility and acceptability. A website was developed and underwent iterative amendment following patient usability testing in focus groups. Patients on follow-up completed a Computer and Internet Usage Questionnaire. Internet users consented to a randomised crossover study to complete paper and online questionnaires, browse the website and participate in a website evaluation interview. Patient website use was tracked. Usability: Website changes were made following patient testing (n= 21). Patients would have liked a 'personalized' website with links to their clinical team, out with the scope of this study. Feasibility: The majority of participants (65%) had Internet access. Age remained a differentiating factor. Acceptability: Final evaluation (n= 103) was positive although many would like to maintain face-to-face hospital contact. User involvement in website design can ensure patient needs are met. A website model for follow-up will suit some patients but others will prefer clinical contact. © 2012 Blackwell Publishing Ltd.

Neurophysiology of the pelvic floor in clinical practice: a systematic literature review

PubMed Central

Bianchi, Francesca; Squintani, Giovanna Maddalena; Osio, Maurizio; Morini, Alberto; Bana, Cristina; Ardolino, Gianluca; Barbieri, Sergio; Bertolasi, Laura; Caramelli, Riccardo; Cogiamanian, Filippo; Currà, Antonio; de Scisciolo, Giuseppe; Foresti, Camillo; Frasca, Vittorio; Frasson, Emma; Inghilleri, Maurizio; Maderna, Luca; Motti, Luisa; Onesti, Emanuela; Romano, Marcello Calogero; Del Carro, Ubaldo

2017-01-01

Summary Neurophysiological testing of the pelvic floor is recognized as an essential tool to identify pathophysiological mechanisms of pelvic floor disorders, support clinical diagnosis, and aid in therapeutic decisions. Nevertheless, the diagnostic value of these tests in specific neurological diseases of the pelvic floor is not completely clarified. Seeking to fill this gap, the members of the Neurophysiology of the Pelvic Floor Study Group of the Italian Clinical Neurophysiology Society performed a systematic review of the literature to gather available evidence for and against the utility of neurophysiological tests. Our findings confirm the utility of some tests in specific clinical conditions [e.g. concentric needle electromyography, evaluation of sacral reflexes and of pudendal somatosensory evoked potentials (pSEPs) in cauda equina and conus medullaris lesions, and evaluation of pSEPs and perineal sympathetic skin response in spinal cord lesions], and support their use in clinical practice. Other tests, particularly those not currently supported by high-level evidence, when employed in individual patients, should be evaluated in the overall clinical context, or otherwise used for research purposes.

Evaluation of Interventions in Clinical Pharmacist-Led Annual Medicare Wellness Visits Compared with Usual Care.

PubMed

Beliard, Regine C; Merrey, Jessica W

2017-11-01

Evaluate and compare the number and types of medication and non-medication-related interventions by clinical pharmacists and nonpharmacists conducting an Annual Medicare Wellness Visit (MWV). Multi-center, retrospective case-control study. Two community primary care internal medicine clinics in urban Maryland. Patients who had a MWV performed January 2014 through October 2015. Pharmacists conducted required components of a MWV and addressed medication or non-medication-related concerns identified while completing the patient health risk assessment. Number and types of medication-related interventions identified by clinical pharmacists compared with nonpharmacists completing the MWV. Patients in the pharmacist-led MWV group more often had medication-related interventions than those in the nonpharmacist group (median 2 vs. 0, respectively; P < 0.00001). Pharmacists tended to identify at least 1 to 2 medication interventions for each patient (30.4% and 34.8%, respectively), and nonpharmacists often did not intervene on medications (62.79% of the time). There were 37 medication-related interventions made by the pharmacist group in a cohort of 23 patients, and 20 medication-related interventions by the nonpharmacist group in a cohort of 43 patients. The pharmacist group most often addressed medication without indication (17 occurrences) followed by nonadherence (6 occurrences). Providers in the nonpharmacist group most often recognized subtherapeutic dosage (7 occurrences) and indication without medication (5 occurrences). Pharmacists completing the MWV had a higher rate of medication-related and non-medication-related interventions than the nonpharmacist group. Pharmacist-led MWVs may lead to more appropriate medication use in elderly patients and serve as a financially sustainable care model to provide clinical pharmacy services in the outpatient setting.

Limited Abdominal Sonography for Evaluation of Children With Right Lower Quadrant Pain.

PubMed

Munden, Martha M; Wai, Shannon; DiStefano, Michael C; Zhang, Wei

2017-01-01

To determine whether a complete abdominal sonographic examination is necessary in the evaluation of children with right lower quadrant pain that is suspicious for appendicitis in the emergency department and whether performing a limited, more-focused study would miss clinically important disease. With Institutional Review Board approval, a retrospective study was performed of 704 patients, from ages 5-19 years, presenting to the emergency department with right lower quadrant pain that was suspicious for appendicitis who underwent a complete abdominal sonographic examination. Data were extracted from the complete abdominal sonographic examination to see whether abnormalities were noted in the pancreas, spleen, and left kidney. Patients' medical charts were reviewed to see whether any positive findings in these organs were clinically important. Of the 65 studies with a finding that would have been missed with a limited study, only 6 were found to be clinically important. Of those, 5 were managed medically and 1 surgically. The chance of missing a potentially important finding using a limited study with our group of patients was 65 of 704 patients (9.2%), with a 95% confidence interval of 7.2% to 11.7%. The chance of missing an abnormality that was clinically important was 6 of 704 patients (0.85%), with a 95% confidence interval of 0.35% to 1.94%. In children older than 5 years with abdominal pain that is suspicious for appendicitis, performing only a limited abdominal sonographic examination that excludes the pancreas, left kidney, and spleen will yield a miss rate for clinically important disease that is acceptably low to justify the savings of examination time. © 2016 by the American Institute of Ultrasound in Medicine.

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. Opportunities for further research and developments in this area are discussed.

A Multidisciplinary Evaluation of a Web-based eLearning Training Programme for SAFRON II (TROG 13.01): a Multicentre Randomised Study of Stereotactic Radiotherapy for Lung Metastases.

PubMed

Pham, D; Hardcastle, N; Foroudi, F; Kron, T; Bressel, M; Hilder, B; Chesson, B; Oates, R; Montgomery, R; Ball, D; Siva, S

2016-09-01

In technically advanced multicentre clinical trials, participating centres can benefit from a credentialing programme before participating in the trial. Education of staff in participating centres is an important aspect of a successful clinical trial. In the multicentre study of fractionated versus single fraction stereotactic ablative body radiotherapy in lung oligometastases (TROG 13.01), knowledge transfer of stereotactic ablative body radiotherapy techniques to the local multidisciplinary team is intended as part of the credentialing process. In this study, a web-based learning platform was developed to provide education and training for the multidisciplinary trial teams at geographically distinct sites. A web-based platform using eLearning software consisting of seven training modules was developed. These modules were based on extracranial stereotactic theory covering the following discrete modules: Clinical background; Planning technique and evaluation; Planning optimisation; Four-dimensional computed tomography simulation; Patient-specific quality assurance; Cone beam computed tomography and image guidance; Contouring organs at risk. Radiation oncologists, medical physicists and radiation therapists from hospitals in Australia and New Zealand were invited to participate in this study. Each discipline was enrolled into a subset of modules (core modules) and was evaluated before and after completing each module. The effectiveness of the eLearning training will be evaluated based on (i) knowledge retention after participation in the web-based training and (ii) confidence evaluation after participation in the training. Evaluation consisted of a knowledge test and confidence evaluation using a Likert scale. In total, 130 participants were enrolled into the eLearning programme: 81 radiation therapists (62.3%), 27 medical physicists (20.8%) and 22 radiation oncologists (16.9%). There was an average absolute improvement of 14% in test score (P < 0.001) after learning. This score improvement compared with initial testing was also observed in the long-term testing (>4 weeks) after completing the modules (P < 0.001). For most there was significant increase in confidence (P < 0.001) after completing all the modules. Copyright © 2016 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.

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

NASA Astrophysics Data System (ADS)

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

2017-08-01

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

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

PubMed

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

2017-07-06

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

Decision analysis to complete diagnostic research by closing the gap between test characteristics and cost-effectiveness.

PubMed

Schaafsma, Joanna D; van der Graaf, Yolanda; Rinkel, Gabriel J E; Buskens, Erik

2009-12-01

The lack of a standard methodology in diagnostic research impedes adequate evaluation before implementation of constantly developing diagnostic techniques. We discuss the methodology of diagnostic research and underscore the relevance of decision analysis in the process of evaluation of diagnostic tests. Overview and conceptual discussion. Diagnostic research requires a stepwise approach comprising assessment of test characteristics followed by evaluation of added value, clinical outcome, and cost-effectiveness. These multiple goals are generally incompatible with a randomized design. Decision-analytic models provide an important alternative through integration of the best available evidence. Thus, critical assessment of clinical value and efficient use of resources can be achieved. Decision-analytic models should be considered part of the standard methodology in diagnostic research. They can serve as a valid alternative to diagnostic randomized clinical trials (RCTs).

Relationship Between Operating Room Teamwork, Contextual Factors, and Safety Checklist Performance.

PubMed

Singer, Sara J; Molina, George; Li, Zhonghe; Jiang, Wei; Nurudeen, Suliat; Kite, Julia G; Edmondson, Lizabeth; Foster, Richard; Haynes, Alex B; Berry, William R

2016-10-01

Studies show that using surgical safety checklists (SSCs) reduces complications. Many believe SSCs accomplish this by enhancing teamwork, but evidence is limited. Our study sought to relate teamwork to checklist performance, understand how they relate, and determine conditions that affect this relationship. Using 2 validated tools for observing and coaching operating room teams, we evaluated the association between checklist performance with surgeon buy-in and 4 domains of surgical teamwork: clinical leadership, communication, coordination, and respect. Hospital staff in 10 South Carolina hospitals observed 207 procedures between April 2011 and January 2013. We calculated levels of checklist performance, buy-in, and measures of teamwork, and evaluated their relationship, controlling for patient and case characteristics. Few teams completed most or all SSC items. Teams more often completed items considered procedural "checks" than conversation "prompts." Surgeon buy-in, clinical leadership, communication, a summary measure of teamwork overall, and observers' teamwork ratings positively related to overall checklist completion (multivariable model estimates from 0.04, p < 0.05 for communication to 0.17, p < 0.01 for surgeon buy-in). All measures of teamwork and surgeon buy-in related positively to completing more conversation prompts; none related significantly to procedural checks (estimates from 0.10, p < 0.01 for communication to 0.27, p < 0.001 for surgeon buy-in). Patient age was significantly associated with completing the checklist and prompts (p < 0.05); only case duration was positively associated with performing more checks (p < 0.10). Surgeon buy-in and surgical teamwork characterized by shared clinical leadership, open communication, active coordination, and mutual respect were critical in prompting case-related conversations, but not in completing procedural checks. Findings highlight the importance of surgeon engagement and high-quality, consistent teamwork for promoting checklist use and ensuring a safe surgical environment. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Assessing Autism in Adults: An Evaluation of the Developmental, Dimensional and Diagnostic Interview-Adult Version (3Di-Adult)

ERIC Educational Resources Information Center

Mandy, William; Clarke, Kiri; McKenner, Michele; Strydom, Andre; Crabtree, Jason; Lai, Meng-Chuan; Allison, Carrie; Baron-Cohen, Simon; Skuse, David

2018-01-01

We developed a brief, informant-report interview for assessing autism spectrum conditions (ASC) in adults, called the Developmental, Dimensional and Diagnostic Interview-Adult Version (3Di-Adult); and completed a preliminary evaluation. Informant reports were collected for participants with ASC (n = 39), a non-clinical comparison group (n = 29)…

Outcome Evaluation of "Family Eats": An Eight-Session Web-Based Program Promoting Healthy Home Food Environments and Dietary Behaviors for African American Families

ERIC Educational Resources Information Center

Cullen, Karen Weber; Thompson, Debbe; Chen, Tzu-An

2017-01-01

This article presents the results of a randomized clinical trial evaluating the eight-session "Family Eats" web-based intervention promoting healthy home food environments for African American families. African American families (n = 126) with 8- to 12-year-old children completed online baseline questionnaires and were randomized into…

Early postoperative healing following buccal single flap approach to access intraosseous periodontal defects.

PubMed

Farina, Roberto; Simonelli, Anna; Rizzi, Alessandro; Pramstraller, Mattia; Cucchi, Alessandro; Trombelli, Leonardo

2013-07-01

This study aims to evaluate the early postoperative healing of papillary incision wounds and its association with (1) patient/site-related factors and technical (surgical) aspects as well as with (2) 6-month clinical outcomes following buccal single flap approach (SFA) in the treatment of intraosseous periodontal defects. Forty-three intraosseous defects in 35 patients were accessed with a buccal SFA alone or in combination with a reconstructive technology (graft, enamel matrix derivative (EMD), graft + EMD, or graft + membrane). Postoperative healing was evaluated at 2 weeks using the Early Wound-Healing Index (EHI). EHI ranged from score 1 (i.e., complete flap closure and optimal healing) to score 4 (i.e., loss of primary closure and partial tissue necrosis). SFA resulted in a complete wound closure at 2 weeks in the great majority of sites. A significantly more frequent presence of interdental contact point and interdental soft tissue crater, and narrower base of the interdental papilla were observed at sites with either EHI > 1 or EHI = 4 compared to sites with EHI = 1. No association between EHI and the 6-month clinical outcomes was observed. At 2 weeks, buccal SFA may result in highly predictable complete flap closure. Site-specific characteristics may influence the early postoperative healing of the papillary incision following SFA procedure. Two-week soft tissue healing, however, was not associated with the 6-month clinical outcomes.

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

PubMed

Prunuske, Jacob

2010-03-01

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

Effect of portfolio assessment on student learning in prenatal training for midwives.

PubMed

Kariman, Nourossadat; Moafi, Farnoosh

2011-01-01

The tendency to use portfolios for evaluation has been developed with the aim of optimizing the culture of assessment. The present study was carried out to determine the effect of using portfolios as an evaluation method on midwifery students' learning and satisfaction in prenatal practical training. In this prospective cohort study, all midwifery students in semester four (n=40), were randomly allocated to portfolio and routine evaluation groups. Based on their educational goals, the portfolio groups prepared packages which consisted of a complete report of the history, physical examinations, and methods of patient management (as evaluated by a checklist) for women who visited a prenatal clinic. During the last day of their course, a posttest, clinical exam, and student satisfaction form were completed. The two groups' mean age, mean pretest scores, and their prerequisite course that they should have taken in the previous semester were similar. The mean difference in the pre and post test scores for the two groups' knowledge and comprehension levels did not differ significantly (P>0.05). The average scores on questions in Bloom's taxonomy 2 and 3 of the portfolio group were significantly greater than those of the routine evaluation group (P=0.002, P=0.03, respectively). The mean of the two groups' clinical exam scores was significantly different. The portfolio group's mean scores on generating diagnostic and therapeutic solutions and the ability to apply theory in practice were higher than those of the routine group. Overall, students' satisfaction scores in the two evaluation methods were relatively similar. Portfolio evaluation provides the opportunity for more learning by increasing the student's participation in the learning process and helping them to apply theory in practice.

The virtual child: evaluation of an internet-based pediatric behavior management simulation.

PubMed

Boynton, James R; Green, Thomas G; Johnson, Lynn A; Nainar, S M Hashim; Straffon, Lloyd H

2007-09-01

This article describes an Internet-based instructional tool designed to give predoctoral dental students a virtual simulation of clinical pediatric dentistry to develop their pediatric behavior management knowledge. Effectiveness of this tool was evaluated using two consecutive classes of junior dental students. The control group was exposed to the traditional behavior management curriculum (two lectures) in a spring term course. The next class of dental students was exposed to the two lectures and, in addition, completed the behavior management simulation during the following spring term. Both groups completed a two-part examination (objective section=18 questions; open-ended section=responses to a clinical situation) designed to test their behavior management knowledge. The simulation group performed significantly better in both parts of the examination (objective section: p=.028; open-ended section: p=.012). The simulation was evaluated by students and perceived by most to be an effective addition to the curriculum. It was concluded that the experimental behavior management simulation, when added to the traditional lecture curriculum, improved pediatric behavior management knowledge in predoctoral dental students.

Collection of social determinants of health in the community clinic setting: a cross-sectional study.

PubMed

Kusnoor, Sheila V; Koonce, Taneya Y; Hurley, Suzanne T; McClellan, Kalonji M; Blasingame, Mallory N; Frakes, Elizabeth T; Huang, Li-Ching; Epelbaum, Marcia I; Giuse, Nunzia B

2018-04-24

Addressing social and behavioral determinants of health (SBDs) may help improve health outcomes of community clinic patients. This cross-sectional study explored how assessing SBDs can be used to complement health data collection strategies and provide clinicians with a more in-depth understanding of their patients. Adult patients, ages 18 and older, at an urban community health care clinic in Tennessee, U.S.A., were asked to complete a questionnaire regarding health status, health history and SBDs while waiting for their clinic appointment. The SBD component included items from the National Academy of Medicine, the Protocol for Responding to and Assessing Patient Assets, Risks, and Experiences instrument, and the Survey of Household Economics and Decisionmaking. Data collection and analysis occurred in 2017. One hundred participants completed the study. The questionnaire took approximately 11 min to complete, and the response rate was 90% or higher for all items except annual household income (unanswered by 40 participants). The median number of negative SBDs was 4 (IQR 2.75-7.0), 96 participants had at least one unmet need, and the most common negative SBD was physical activity (75%; 75/100). The hybrid questionnaire provided insight into a community clinic population's SBDs and allowed for a more complete understanding than a single questionnaire alone. The brief questionnaire administration time and low non-response rate support the questionnaire's feasibility in the community clinic setting, and results can be used by clinicians to further the personalization goals of precision medicine. Next steps include evaluating how to connect patients with appropriate resources for addressing their SBDs.

The value of a core clinical rotation in urology for medical students.

PubMed

Patel, Premal; Nayak, Jasmir G; McGregor, Thomas B

2015-01-01

In 2013, our institution underwent a change to the undergraduate medical curriculum whereby a clinical urology rotation became mandatory. In this paper, we evaluated the perceived utility and value of this change in the core curriculum. Third year medical students, required to complete a mandatory 1-week clinical urology rotation, were asked to complete a survey before and after their rotation. Fourth year medical students, not required to complete this rotation, were also asked to complete a questionnaire. Chi-squared and Fisher's exact test were used for data analysis. In total, 108 third year students rotated through urology during the study period. Of these, 66 (61%) completed the pre-rotation survey and 54 (50%) completed the post-rotation survey. In total, there were 110 fourth year students. Of these, 44 (40%) completed the questionnaire. After completing their mandatory rotations, students felt more comfortable managing and investigating common urological problems, such as hematuria and renal colic. Students felt they had a better understanding of how to insert a Foley catheter and felt comfortable independently inserting a Foley catheter. Importantly, students felt they knew when to consult urology and were also more likely to consider a career in urology. Compared to fourth year students, third year students felt urology was an important component to a family medicine practice and felt they had a better understanding of when to consult urology. The introduction of a mandatory urology rotation for undergraduate medical students leads to a perceived improvement in fundamental urological knowledge and skill set of rotating students. This mandatory rotation provides a valuable experience that validates its inclusion.

Clinical and cost-effectiveness of non-medical prescribing: A systematic review of randomised controlled trials

PubMed Central

Marriott, John; Graham-Clarke, Emma; Shirley, Debra; Rushton, Alison

2018-01-01

Objective To evaluate the clinical and cost-effectiveness of non-medical prescribing (NMP). Design Systematic review. Two reviewers independently completed searches, eligibility assessment and assessment of risk of bias. Data sources Pre-defined search terms/combinations were utilised to search electronic databases. In addition, hand searches of reference lists, key journals and grey literature were employed alongside consultation with authors/experts. Eligibility criteria for included studies Randomised controlled trials (RCTs) evaluating clinical or cost-effectiveness of NMP. Measurements reported on one or more outcome(s) of: pain, function, disability, health, social impact, patient-safety, costs-analysis, quality adjusted life years (QALYs), patient satisfaction, clinician perception of clinical and functional outcomes. Results Three RCTs from two countries were included (n = 932 participants) across primary and tertiary care settings. One RCT was assessed as low risk of bias, one as high risk of bias and one as unclear risk of bias. All RCTs evaluated clinical effectiveness with one also evaluating cost-effectiveness. Clinical effectiveness was evaluated using a range of safety and patient-reported outcome measures. Participants demonstrated significant improvement in outcomes when receiving NMP compared to treatment as usual (TAU) in all RCTs. An associated cost analysis showed NMP to be more expensive than TAU (regression coefficient p = 0.0000), however experimental groups generated increased QALYs compared to TAU. Conclusion Limited evidence with overall unclear risk of bias exists evaluating clinical and cost-effectiveness of NMP across all professions and clinical settings. GRADE assessment revealed moderate quality evidence. Evidence suggests that NMP is safe and can provide beneficial clinical outcomes. Benefits to the health economy remain unclear, with the cost-effectiveness of NMP assessed by a single pilot RCT of low risk of bias. Adequately powered low risk of bias RCTs evaluating clinical and cost effectiveness are required to evaluate NMP across clinical specialities, professions and settings. Registration PROSPERO (CRD42015017212). PMID:29509763

The implementation of computerized cognitive behavioural therapies in a service user-led, third sector self help clinic.

PubMed

Cavanagh, Kate; Seccombe, Nick; Lidbetter, Nicky

2011-07-01

The efficacy and effectiveness of a computerized cognitive behavioural therapy (CCBT) package, Beating the Blues, has been demonstrated in a large randomized controlled trial and several pragmatic studies in the National Health Service (NHS). The current study tests the generalizability of this finding to the implementation of CCBT in a service user-led, third sector Self Help Clinic. 510 referrals for the Beating the Blues program were received over a 16 month period in routine care. The Patient Health Questionnaire Depression (PHQ-9) and Anxiety (GAD-7) Scales were administered pre-treatment and during each treatment session. The 10-item Clinical Outcomes in Routine Evaluation-Outcome Measure (CORE-OM), Work and Social Adjustment Scale and Patient Experience Questionnaire were also administered pre-treatment and immediately on completing treatment. More than two-thirds of referrals were suitable for treatment and completed a baseline assessment; 84% of these started the Beating the Blues program. Two-hundred and twenty-six people meeting caseness criteria at baseline completed at least two sessions of CCBT. Of these, 50% met recovery criteria at their final point of measurement. Completer and intention-to-treat analysis also demonstrated statistically and clinically significant improvements on key outcome measures. CCBT can be effectively implemented in a service user-led, third sector Self Help Clinic, increasing access to psychological therapies to meet local needs for tier two interventions for depression and anxiety.

The leather ankle lacer.

PubMed Central

Saltzman, C. L.; Shurr, D.; Kamp, J.; Cook, T. A.

1995-01-01

The purpose of this study was to evaluate the efficacy of a leather ankle lacer for treating painful problems of the ankle and hindfoot. The evaluation involved patient self assessment, clinical examination and radiographic determination of the effectiveness of the ankle lacer. Overall, patients had moderate pain relief with significant but not complete restriction of motion. Based on this study and our clinical experience, we find the leather ankle lacer to be a compliant and comfortable treatment strategy for patients with painful ankle and hindfoot problems who desire some retained motion. Images Figure 1A & B Figure 2 Figure 3 PMID:7634034

Computer interviewing in urogynaecology: concept, development and psychometric testing of an electronic pelvic floor assessment questionnaire in primary and secondary care.

PubMed

Radley, S C; Jones, G L; Tanguy, E A; Stevens, V G; Nelson, C; Mathers, N J

2006-02-01

To develop and evaluate a Web-based, electronic pelvic floor symptoms assessment questionnaire (e-PAQ)1 for women. A cross-sectional study in primary and secondary care. Two general practices, two community health clinics and a secondary care urogynaecology clinic. A total of 432 women (204 in primary care and 228 in secondary care) were recruited between June 2003 and January 2004. The e-PAQ was located on a workstation (computer, touchscreen and printer). Women completed the e-PAQ prior to their appointment. Untreated women in primary care were asked to return seven days later to complete the e-PAQ a second time (test-retest). Factor analysis, reliability, validity, patient satisfaction, completion times and system costs. In secondary care, factor analysis identified 14 domains within the four dimensions (urinary, bowel, vaginal and sexual symptoms) with internal consistency (Cronbach's alpha)>or=0.7 in 11 of these. In primary care, alpha values were all>or=0.7 and test-retest analysis found acceptable intraclass correlations of 0.50-0.95 (P<0.001) for all domains. A measure of face validity and utility was gained using a nine-item questionnaire, which yielded strongly positive patient views on relevance and acceptability. The e-PAQ offers a user-friendly clinical tool, which provides valid and reliable data. The system offers comprehensive symptoms and quality of life evaluation and may enhance the clinical episode as well as the quality of care for women with pelvic floor disorders.

Impact of a Clinical Pharmacy Service on the Management of Patients in a Sickle Cell Disease Outpatient Center.

PubMed

Han, Jin; Bhat, Shubha; Gowhari, Michel; Gordeuk, Victor R; Saraf, Santosh L

2016-11-01

Ambulatory care clinical pharmacy services have expanded beyond primary care settings, but literature supporting the benefits of clinical pharmacy involvement with patients who have rare diseases such as sickle cell disease (SCD) is lacking. Hydroxyurea is the only agent approved by the U.S. Food and Drug Administration for the treatment of SCD; full benefit in controlling pain episodes and other complications is achieved through monitored escalation to a maximum tolerated dose. The primary objective of this analysis was to evaluate the impact of a newly implemented clinical pharmacy service on the management of patients with SCD. We performed a retrospective cross-sectional analysis of 385 adults with SCD who received care between January 1, 2014, and December 31, 2014, at a single Sickle Cell Outpatient Center that implemented a clinical pharmacy service in August 2013. Data were collected on hydroxyurea dose escalation, immunization completion rates, and health maintenance metrics (screening for nephropathy with microalbuminuria testing, retinopathy with annual retinal examinations, and pulmonary hypertension with echocardiography). The impact of the clinical pharmacy service on quality measurements was evaluated by using univariate and multivariate analyses. The number of pharmacist encounters, defined as a clinic visit when a clinical pharmacist interacted with a patient as documented in the medical records, was associated with an improved hydroxyurea dose escalation rate (odds ratio [OR] 1.48, 95% confidence interval [CI] 1.07-2.05, p=0.02). Immunization rates for the 23-valent pneumococcal polysaccharide vaccine, the 13-valent pneumococcal conjugate vaccine, and influenza vaccine were 66%, 47%, and 62%, respectively. The number of pharmacist encounters was associated with improved immunization completion rates (OR 1.38, 95% CI 1.17-1.62, p<0.001). Improved screening for microalbuminuria (OR 2.14, 95% CI 1.60-2.86, p<0.001) and sickle cell retinopathy (OR 1.16, 95% CI 1.00-1.35, p=0.05) were also associated with the number of pharmacist encounters. A new clinical pharmacy service implemented in managing a rare disease, SCD, was associated with an improved hydroxyurea dose escalation rate, immunization completion rates, and health maintenance metrics. © 2016 Pharmacotherapy Publications, Inc.

The Pine Ridge-Mayo National Aeronautics and Space Administration Telemedicine Project: Program Activities and Participant Reactions

NASA Technical Reports Server (NTRS)

Kottke, T. E.; Little Finger, L.; Trapp, M. A.; Panser, L. A.; Novotny, P. J.

1996-01-01

OBJECTIVE: To determine the response of participants to the Pine Ridge-Mayo National Aeronautics and Space Administration telemedicine project. DESIGN: We describe a 3-month demonstration project of medical education and clinical consultations conducted by means of satellite transmission. Postparticipation questionnaires and a postproject survey were used to assess the success of the activity. MATERIAL AND METHODS: Patients and employees at the Pine Ridge Indian Health Service Hospital in southwestern South Dakota and employees at Mayo Clinic Rochester participated in a telemedicine project, after which they completed exit surveys and a postproject questionnaire to ascertain the acceptability of this mode of health care. RESULTS: Almost all Pine Ridge and Mayo Clinic participants viewed the project as beneficial. The educational sessions received favorable evaluations, and almost two-thirds of the patients who completed evaluations thought the consultation had contributed to their medical care. More than 90% of the respondents from Pine Ridge and more than 85% of the respondents from Mayo Clinic Rochester said that they would recommend participation in this project to others. More than 90% of respondents from Pine Ridge and 80% of Mayo respondents agreed with the statement that the project should continue. CONCLUSION: These data suggest that a program of clinical consultation services, professional education, and patient education available by telemedicine might be viewed as beneficial.

The perceived personal control (PPC) questionnaire: reliability and validity in a sample from the United Kingdom.

PubMed

McAllister, Marion; Wood, Alex M; Dunn, Graham; Shiloh, Shoshana; Todd, Chris

2012-02-01

Outcome measures are important assessment tools to evaluate clinical genetics services. Research suggests that perceived personal control (PPC) is an outcome valued by clinical genetics patients and clinicians. The PPC scale was developed in Hebrew to capture three dimensions of PPC: Cognitive, decisional, and behavioral control. This article reports on the first psychometric validation of the English translation of the PPC scale. Previous research has shown that the Hebrew and Dutch translations have good psychometric properties. However, the psychometric properties of the English translation have not been tested, and there is disagreement about the factor structure, with implications for how to score the measure. A total of 395 patients attending a clinical genetics appointment in the United Kingdom completed several measures at baseline, and a further 241 also completed measures at 2-4 weeks follow-up. The English language PPC has (a) a one-factor structure, (b) convergent validity with internal health locus of control (IHLC), satisfaction with life (SWL), depression, and authenticity, (c) high internal consistency (α = 0.83), and (d) sensitivity to change, being able to identify moderate changes in PPC following clinic attendance (Cohen's d = 0.40). These properties suggest the English language PPC measure is a useful tool for both clinical genetics research and for use as a Patient Reported Outcome Measure (PROM) in service evaluation. Copyright © 2011 Wiley Periodicals, Inc.

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

PubMed

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

2018-01-01

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

Cardiac MRI in patients with complex CHD following primary or secondary implantation of MRI-conditional pacemaker system.

PubMed

Al-Wakeel, Nadya; O h-Ici, Darach; Schmitt, Katharina R; Messroghli, Daniel R; Riesenkampff, Eugénie; Berger, Felix; Kuehne, Titus; Peters, Bjoern

2016-02-01

In patients with CHD, cardiac MRI is often indicated for functional and anatomical assessment. With the recent introduction of MRI-conditional pacemaker systems, cardiac MRI has become accessible for patients with pacemakers. The present clinical study aims to evaluate safety, susceptibility artefacts, and image reading of cardiac MRI in patients with CHD and MRI-conditional pacemaker systems. Material and methods CHD patients with MRI-conditional pacemaker systems and a clinical need for cardiac MRI were examined with a 1.5-T MRI system. Lead function was tested before and after MRI. Artefacts and image readings were evaluated using a four-point grading scale. A total of nine patients with CHD (mean age 34.0 years, range 19.5-53.6 years) received a total of 11 cardiac MRI examinations. Owing to clinical indications, seven patients had previously been converted from conventional to MRI-conditional pacemaker systems. All MRI examinations were completed without adverse effects. Device testing immediately after MRI and at follow-up showed no alteration of pacemaker device and lead function. Clinical questions could be addressed and answered in all patients. Cardiac MRI can be performed safely with high certainty of diagnosis in CHD patients with MRI-conditional pacemaker systems. In case of clinically indicated lead and box changing, CHD patients with non-MRI-conditional pacemaker systems should be considered for complete conversion to MRI-conditional systems.

Prospective Genotyping of Mycobacterium tuberculosis from Fresh Clinical Samples

PubMed Central

Bidovec-Stojkovič, Urška; Seme, Katja; Žolnir-Dovč, Manca; Supply, Philip

2014-01-01

Shorter time-to-result is key for improving molecular-guided epidemiological investigation of tuberculosis (TB) cases. We performed a prospective study to evaluate the use of standardized MIRU-VNTR (mycobacterial interspersed repetitive-unit-variable-number tandem-repeat) typing of Mycobacterium tuberculosis directly on 79 fresh clinical samples from 26 TB patients consecutively enrolled over a 17-month period. Overall, complete 24-locus types were obtained for 18 out of the 26 (69.2%) patients and 14 of the 16 grade 3+ and grade 2+ samples (87.5%). The degree of completion of the genotypes obtained significantly correlated with smear microscopy grade both for 26 first samples (p = 0.0003) and for 53 follow-up samples (p = 0.002). For 20 of the 26 patients for whom complete or even incomplete M. tuberculosis isolate genotypes were obtained, typing applied to the clinical samples allowed the same unambiguous conclusions regarding case clustering or uniqueness as those that could have been drawn based on the corresponding cultured isolates. Standard 24 locus MIRU-VNTR typing of M. tuberculosis can be applied directly to fresh clinical samples, with typeability depending on the bacterial load in the sample. PMID:25313883

Optimizing otoscopy competency in audiology students through supplementary otoscopy training.

PubMed

Kaf, Wafaa A; Masterson, Caleb G; Dion, Nancy; Berg, Susan L; Abdelhakiem, Mohamed K

2013-10-01

Scope of practice in audiology encompasses proficiency in visual inspection of ear canal and tympanic membrane (TM) as well as otoscopy interpretation skills to determine normal versus abnormal conditions of outer and middle ear. Audiology students can develop skills in otoscopy through education and supervised training. Studies have shown that additional otoscopy training increased skills in medical students and general practitioners. However, educational and supervised practices targeting otoscopy competency during audiology graduate coursework are lacking. Also, no studies have attempted to determine otoscopy skills among audiology students. To determine the effectiveness of the otoscopy training model on clinical competency and confidence level of audiology students in performing and interpreting otoscopy. A combination of experimental treatment design with random assignment of treatment and control groups and delayed treatment for control group. Thirty-two first- and second-year audiology graduate students who were enrolled in a pediatric audiology class participated in this study. Students were randomly assigned to the control (n = 16, 14 females) or experimental (n = 16, 14 females) group. Participants in the experimental group received supplementary otoscopy training including didactic otoscopy lectures as well as clinical training using manikin ears. The control group received the same pretest and posttest and then completed a third assessment (posttest 2) after receiving the same training. An evaluation of knowledge and skills regarding otoscopy between groups and time was conducted at three times: (a) pretraining, (b) upon completion of training for the experimental group, (c) upon completion of training by the control group. The evaluation consisted of a written exam, a clinical exam, and a self-perception rating of confidence. Both written exam scores and clinical exam scores (otoscopy manikin) were analyzed via two-way analyses of variance (ANOVAs), whereas chi-square (χ²) statistic was conducted to evaluate the effects of training on the confidence level of students of both groups. Experimental and control groups demonstrated significant increased overall competency in otoscopy following the otoscopy training model with didactic and laboratory components. Posttest confidence ratings showed increases in all groups, and there were no significant differences between groups. The need for supplementary otoscopy training was warranted by low knowledge and clinical competency in otoscopy skills of audiology students as measured by pretest mean scores. After completing the training, both experimental and control groups showed significant improvement in knowledge and competency. Results also suggest that perceived confidence ratings may be misleading in determining students' clinical otoscopy skills. American Academy of Audiology.

Bone marrow hypoplasia associated with fenbendazole administration in a dog.

PubMed

Gary, Anthony T; Kerl, Marie E; Wiedmeyer, Charles E; Turnquist, Susan E; Cohn, Leah A

2004-01-01

A 1.5-year-old Doberman pinscher was presented with sudden-onset of fever and malaise. Twelve days prior to presentation, fenbendazole therapy was initiated for a suspected lungworm infection. Results of a complete blood count on presentation showed pancytopenia, while histopathological evaluation of a bone marrow core sample revealed bone marrow hypoplasia of undetermined etiology. Bactericidal antibiotics and fluid therapy, as well as discontinuation of fenbendazole administration, led to a complete resolution of clinical and hematological abnormalities within 15 days. An idiosyncratic reaction to fenbendazole was suspected based on the absence of infectious, neoplastic, autoimmune, and toxic etiologies, as well as resolution of clinical signs and pancytopenia upon drug withdrawal.

Spontaneous correction of pathologic tooth migration and reduced infrabony pockets following nonsurgical periodontal therapy: a case report.

PubMed

Sato, Shuichi; Ujiie, Hisashi; Ito, Koichi

2004-10-01

This case report describes the spontaneous correction of pathologic tooth migration and reduced infrabony pockets after nonsurgical periodontal therapy. A 3-mm diastema between the maxillary incisors was closed completely, and the mandibular teeth, which had migrated pathologically, returned to the optimal position. Clinical evaluation showed a significant reduction in probing depth, with increased clinical attachment and bone deposition demonstrated radiologically.

Perceived emotional aptitude of clinical laboratory sciences students compared to students in other healthcare profession majors.

PubMed

Adams, Austin; McCabe, Kristin; Zundel, Cassandra; Price, Travis; Dahl, Corey

2011-01-01

Emotional aptitude can be defined as the ability to recognize and manage one's own emotions and interpret the emotions of others. It has been speculated that Clinical Laboratory Sciences students may lack the emotional skills to most effectively interact with patients and other healthcare professionals, therefore a logical hypothesis would be that they would evaluate their own emotional intelligence lower than students from other healthcare majors. While this has been a topic of discussion in healthcare, a lack of research has been conducted to validate this assumption. This study assesses the perceived emotional aptitude of Clinical Laboratory Sciences students compared to students of other healthcare majors in the Dumke College of Health Professions at Weber State University. The perceived emotional aptitude of the healthcare students was determined by completion of a self-evaluation questionnaire that included questions about one's emotions, their understanding of others' emotions, and how they manage conflict. A total of 401 questionnaires were completed, compiled, and analyzed. Although minor differences were seen in the responses, statistical analysis found these differences to be insignificant. The perceived emotional aptitude of Clinical Laboratory Sciences students was insignificantly different than that of students of other healthcare majors at the Dumke College of Health Professions.

Efficacy of bone substitute material in preserving volume when placing a maxillary immediate complete denture: study protocol for the PANORAMIX randomized controlled trial.

PubMed

Rignon-Bret, Christophe; Hadida, Alain; Aidan, Alexis; Nguyen, Thien-Huong; Pasquet, Gerard; Fron-Chabouis, Helene; Wulfman, Claudine

2016-05-20

Bone preservation is an essential issue in the context of last teeth extraction and complete edentulism. The intended treatment, whether a complete denture or an implant placement, is facilitated with a voluminous residual ridge. Bone resorption after multiple extractions has not been as well studied as the bone resorption that occurs after the extraction of a single tooth. Recent advances in bone substitute materials have revived this issue. The purpose of this study is to evaluate the interest in using bone substitute material to fill the socket after last teeth extraction in a maxillary immediate complete denture procedure compared with the conventional protocol without socket filling. A randomized, controlled, clinical trial was designed. The 34 participants eligible for maxillary immediate complete denture were divided into two groups. Complete dentures were prepared despite persistence of the last anterior teeth. The control group received a conventional treatment including denture placement immediately after extractions. In the experimental group, in addition to the immediate denture placement, a xenograft bone-substitute material (Bio-Oss Collagen®) was placed in the fresh sockets. The primary outcome of the study is to compare mean bone ridge height loss 1 year after maxillary immediate complete denture placement, with or without bone-substitute material, in incisor and canine sockets. The secondary outcomes are to compare the average bone ridge height and width loss for each extraction site. An original quantitative evaluation method using cone beam computed tomography was designed for reproducible measurements, with a radio-opaque denture duplicate. Two independent operators perform the radiologic measurements. The immediate complete denture technique limits bone resorption in multiple extraction situations and thus allows better denture retention and better options for implant placement. To compare the benefit of using any bone socket-filling material, we proposed a quantitative evaluation protocol of resorption in the specific case of the last anterior maxillary teeth extraction with immediate denture placement. ClinicalTrials.gov, NCT02120053 . Registered on 18 April 2014.

Changes in information behavior in clinical teams after introduction of a clinical librarian service

PubMed Central

Urquhart, Christine; Turner, Janet; Durbin, Jane; Ryan, Jean

2007-01-01

Objectives: The eighteen-month evaluation of a clinical librarian project (October 2003–March 2005) conducted in North Wales, United Kingdom (UK) assessed the benefits of clinical librarian support to clinical teams, the impact of mediated searching services, and the effectiveness of information skills training, including journal club support. Methods: The evaluation assessed changes in teams' information-seeking behavior and their willingness to delegate searching to a clinical librarian. Baseline (n = 69 responses, 73% response rate) and final questionnaire (n = 57, 77% response rate) surveys were complemented by telephone and face-to-face interviews (n = 33) among 3 sites served. Those attending information skills training sessions (n = 130) completed evaluations at the session and were surveyed 1 month after training (n = 24 questionnaire responses, n = 12 interviews). Results: Health professionals in clinical teams reported that they were more willing to undertake their own searching, but also more willing to delegate some literature searching, than at the start of the project. The extent of change depended on the team and the type of information required. Information skills training was particularly effective when organized around journal clubs. Conclusions: Collaboration with a clinical librarian increased clinician willingness to seek information. Clinical librarian services should leverage structured training opportunities such as journal clubs. PMID:17252062

Evaluation of a clinical needs assessment and exploration of the associated supports for students with a disability in clinical practice: part 2.

PubMed

Howlin, Frances; Halligan, Phil; O'Toole, Sinead

2014-09-01

Engagement and successful completion of nursing and midwifery programmes may be predicated on the identification and implementation of reasonable accommodations to facilitate clinical learning for students with a disability. This qualitative study aims to evaluate a clinical needs assessment for students with a disability and explore their experiences of support in clinical practice. A purposive sample of year one undergraduate students was used. Four students consented to participate and undertook an individual interview. Their disabilities were categorised as specific learning disability (dyslexia) (n = 3) and mental health (n = 1). Data analysis revealed two main themes 'students' experiences of disclosure' and 'receiving support'. Findings revealed that all students disclosed on placement, however, the extent of disclosure was influenced by personal and environmental factors. Students used the clinical needs assessment to highlight accommodations to clinical staff on placement. Issues of concern that arose, included communication between all key stakeholders, negative staff attitudes and the need to improve the provision of accommodations. This preliminary evaluation indicates that the Clinical Needs Assessment bridges the gap in provision of student support between higher education and healthcare institutions. Findings suggest that competence based needs assessments can identify individualised reasonable accommodations for students undertaking clinical placements. Copyright © 2014 Elsevier Ltd. All rights reserved.

A Clinical Evaluation Denture Adhesives Used by Patients With Xerostomia

PubMed Central

Bogucki, Zdzislaw A.; Napadlek, Piotr; Dabrowa, Tomasz

2015-01-01

Abstract The purpose of study was to analyze the participants’ opinions concerning the effectiveness of 6 denture adhesives (DA). The study group included 60 participants. Criteria for selecting the patients were as follows: reduced retention and stabilization of maxillary complete dentures and xerostomia. These features were evaluated on basis of clinical examination and standard sialometry tests (u-SFR). Retention of maxillary dentures was scored by modified Kapur index before application of DA. All participants were divided randomly into 6 groups regarding the use of the 6 DA during a 6-month period. After this time, participants completed an HRQL questionnaire. DA noticeably improved retention and stabilization of maxillary complete dentures. DA in the glue form had the best retention effectiveness in participants with xerostomia. These materials are difficult to clean from the denture base. The data are presented in tables and figures. The results of the study collected positive influence of adhesives on retention of dentures in xerostomia patients. The cleaning dentures and denture bearing tissues was difficult. DA help in the use of prostheses, but it is also necessary for the treatment of the causes and symptoms of xerostomia. PMID:25700320

The Analysis of Constitutions of Traditional Chinese Medicine in Relation to Cerebral Infarction in a Chinese Sample.

PubMed

Liu, Jiaqi; Xu, Fei; Mohammadtursun, Nabijan; Lv, Yubao; Tang, Zihui; Dong, Jingcheng

2018-05-01

To investigate the relationships between the constitutions of Traditional Chinese Medicine (TCM) and patients with cerebral infarction (CI) in a Chinese sample. A total of 3748 participants with complete data were available for data analysis. All study subjects underwent complete clinical baseline characteristics' evaluation, including a physical examination and response to a structured, nurse-assisted, self-administrated questionnaire. A population of 2010 neutral participants were used as the control group. Multiple variable regression (MLR) were employed to estimate the relationship between constitutions of TCM and the outcome. A cross-sectional study was conducted to evaluate the association of body constitution of TCM and CI. Communications and healthcare centers in Shanghai. A total of 3748 participants with complete data were available for data analysis. All study subjects underwent complete clinical baseline characteristics' evaluation, including a physical examination and response to a structured, nurse-assisted, self-administrated questionnaire. A population of 2010 neutral participants were used as the control group. MLR were employed to estimate the relationship between constitutions of TCM and the outcome. The prevalence of CI was 2.84% and 4.66% in neutral participants and yang-deficient participants (p = 0.012), respectively. Univariate analysis demonstrated a positive correlation between yang deficiency and CI. After adjustment for relevant potential confounding factors, the MLR detected significant associations between yang deficiency and CI (odds ratio = 1.44, p = 0.093). A yang-deficient constitution was significantly and independently associated with CI. A higher prevalence of CI was found in yang-deficient participants as compared with neutral participants.

Evaluation of the end user (dentist) experience of undertaking clinical audit in the post April 2001 general dental services (GDS) scheme.

PubMed

Cannell, P J

2012-09-01

A mandatory scheme for clinical audit in the general dental services (GDS) was launched in April 2001. No evaluation of this mandatory scheme exists in the literature. This study provides an evaluation of this scheme. More recently a new dental contract was introduced in the general dental services (GDS) in April 2006. Responsibility for clinical audit activities was devolved to primary care trusts (PCTs) as part of their clinical governance remit. All GDPs within Essex were contacted by letter and invited to participate in the research. A qualitative research method was selected for this evaluation, utilising audio-taped semi-structured research interviews with eight general dental practitioners (GDPs) who had taken part in the GDS clinical audit scheme and who fitted the sampling criteria and strategy. The evaluation focused on dentists' experiences of the scheme. The main findings from the analysis of the GDS scheme data suggest that there is clear evidence of change following audit activities occurring within practices and for the benefit of patients. However, often it is the dentist only that undertakes a clinical audit project rather than the dental team, there is a lack of dissemination of project findings beyond the individual participating practices, very little useful feedback provided to participants who have completed a project and very limited use of formal re-auditing of a particular topic. This study provides evaluation of the GDS clinical audit scheme. Organisations who propose to undertake clinical audit activities in conjunction with dentistry in the future may benefit from incorporating and/or developing some findings from this evaluation into their project design and avoiding others.

Third party laboratory data management: Perspective with respect to clinical data management.

PubMed

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data.

Third party laboratory data management: Perspective with respect to clinical data management

PubMed Central

Johnson, Jasmin; Kanagali, Vishwanath; Prabu, D.

2014-01-01

Third party lab vendor provides support for laboratory, biological samples analytics data, collected during the clinical trial. Third party laboratory data is considered to be very significant for the clinical trial data management process. Although outsourcing these services is considered to be advantageous for clinical trials, there are some risks involved. Hence, pharmaceutical companies proactively select, track and evaluate third party vendors on a regular basis before, during and after the completion of the contract. The data manager has a significant role to play in effective management of third party vendor data. PMID:24551587

Development and Feasibility Testing of PROMPT-Care, an eHealth System for Collection and Use of Patient-Reported Outcome Measures for Personalized Treatment and Care: A Study Protocol.

PubMed

Girgis, Afaf; Delaney, Geoff P; Arnold, Anthony; Miller, Alexis Andrew; Levesque, Janelle V; Kaadan, Nasreen; Carolan, Martin G; Cook, Nicole; Masters, Kenneth; Tran, Thomas T; Sandell, Tiffany; Durcinoska, Ivana; Gerges, Martha; Avery, Sandra; Ng, Weng; Della-Fiorentina, Stephen; Dhillon, Haryana M; Maher, Ashley

2016-11-24

Patient-reported outcome (PRO) measures have been used widely to screen for depression, anxiety, and symptoms in cancer patients. Computer-based applications that collect patients' responses and transfer them to the treating health professional in real time have the potential to improve patient well-being and cancer outcomes. This study will test the feasibility and acceptability of a newly developed eHealth system which facilitates PRO data capture from cancer patients, data linkage and retrieval to support clinical decisions and patient self-management, and data retrieval to support ongoing evaluation and innovative research. The eHealth system is being developed in consultation with 3 overarching content-specific expert advisory groups convened for this project: the clinical advisory group, technical advisory group, and evaluation advisory group. The following work has already been completed during this phase of the study: the Patient-Reported Outcome Measures for Personalized Treatment and Care (PROMPT-Care) eHealth system was developed, patient-reported outcomes were selected (distress, symptoms, unmet needs), algorithms to inform intervention thresholds for clinical and self-management were determined, clinician PRO feedback summary and longitudinal reports were designed, and patient self-management resources were collated. PROsaiq, a custom information technology system, will transfer PRO data in real time into the hospital-based oncology information system to support clinical decision making. The PROMPT-Care system feasibility and acceptability will be assessed through patients completing PROMPT-Care assessments, participating in face-to-face cognitive interviews, and completing evaluation surveys and telephone interviews and oncology staff participating in telephone interviews. Over the course of 3 months, the system will be pilot-tested with up to 50 patients receiving treatment or follow-up care and 6 oncology staff at 2 hospitals in New South Wales, Australia. Data will be collected to determine the accuracy and completeness of data transfer procedures, extent of missing data from participants' assessments, acceptability of the eHealth system and usefulness of the self-management resources (via patient evaluation surveys and interviews), and acceptability and perceived usefulness of real-time PRO reporting (via oncology staff interviews) at the completion of the pilot phase. This research investigates implementation of evidence into real world clinical practice through development of an efficient and user-friendly eHealth system. This study of feasibility and acceptability of the newly developed eHealth system will inform the next stage of larger scale testing and future implementation of the system as part of routine care. Australian New Zealand Clinical Trials Registry ACTRN1261500135294; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=369299&isReview=true (Archived by WebCite at http://www.webcitation.org/6lzylG5A0). ©Afaf Girgis, Geoff P Delaney, Anthony Arnold, Alexis Andrew Miller, Janelle V Levesque, Nasreen Kaadan, Martin G Carolan, Nicole Cook, Kenneth Masters, Thomas T Tran, Tiffany Sandell, Ivana Durcinoska, Martha Gerges, Sandra Avery, Weng Ng, Stephen Della-Fiorentina, Haryana M Dhillon, Ashley Maher. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.11.2016.

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

PubMed

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

2011-01-01

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

Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF).

PubMed

Gelhorn, Heather L; Roberts, Laurie J; Khandelwal, Nikhil; Revicki, Dennis A; DeRogatis, Leonard R; Dobs, Adrian; Hepp, Zsolt; Miller, Michael G

2017-08-01

The Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF) is a patient-reported outcome measurement designed to evaluate the symptoms of hypogonadism. The HIS-Q-SF is an abbreviated version including17 items from the original 28-item HIS-Q. To conduct item analyses and reduction, evaluate the psychometric properties of the HIS-Q-SF, and provide guidance on score interpretation. A 12-week observational longitudinal study of hypogonadal men was conducted as part of the original HIS-Q psychometric evaluation. Participants completed the original HIS-Q every 2 weeks. Blood samples were collected to evaluate testosterone levels. Participants completed the Aging Male's Symptoms Scale, the International Index of Erectile Function, the Short Form-12, and the PROMIS Sexual Activity, Satisfaction with Sex Life, Sleep Disturbance, and Applied Cognition Scales (baseline and weeks 6 and 12). Clinicians completed the Clinical Global Impression of Severity and Change scales and a clinical form. Item performance was evaluated using descriptive statistics and Rasch analyses. Reliability (internal consistency and test-retest), validity (concurrent and know groups), and responsiveness were assessed. One hundred seventy-seven men participated (mean age = 54.1 years, range = 23-83). Similar to the full HIS-Q, the final abbreviated HIS-Q-SF instrument includes five domains (sexual, energy, sleep, cognition, and mood) with two sexual subdomains (libido and sexual function). For key domains, test-retest reliability was very good, and construct validity was good for all domains. Known-groups validity was demonstrated for all domain scores, subdomain scores, and total score based on the Clinical Global Impression-Severity. All domains and subdomains were responsive to change based on patient-rated anchor questions. The HIS-Q-SF could be a useful tool in clinical practice, epidemiologic studies, and other academic research settings. Careful consideration was given to the selection of the final HIS-Q-SF items based on quantitative data and clinical expert feedback. Overall, the reduced set of items demonstrated strong psychometric properties. Testosterone levels for the participating men were not as low as anticipated, which could have limited the ability to examine the relations between the HIS-Q-SF and testosterone levels. Further, the analyses used data collected through administration of the full HIS-Q, and future studies should administer the standalone HIS-Q-SF to replicate the psychometric analyses reported in the present study. Similar to the original HIS-Q, the HIS-Q-SF has evidence supporting reliability, validity, and responsiveness. The short form includes a smaller set of items that might be more suitable for use in clinical practice or academic research settings. Gelhorn HL, Roberts LJ, Khandelwal N, et al. Psychometric Evaluation of the Hypogonadism Impact of Symptoms Questionnaire Short Form (HIS-Q-SF). J Sex Med 2017;14:1046-1058. Copyright © 2017 International Society for Sexual Medicine. Published by Elsevier Inc. All rights reserved.

Utility of routine psychological screening in the childhood cancer survivor clinic.

PubMed

Recklitis, Christopher; O'Leary, Tara; Diller, Lisa

2003-03-01

This study examined the utility of routine psychologic screening in a childhood cancer survivor clinic by evaluating patient acceptance, comparing subjects' symptoms to normative data, examining the utility of specific tests, and identifying risk factors associated with psychological distress. During their annual clinic visit, 101 adult survivors of childhood cancer (median age, 25 years) completed the Symptom Checklist 90 Revised (SCL-90), as well as the Short Form 36 (SF-36), Beck Depression Inventory (BDI), and one additional suicide question. Psychological distress was operationally defined according to the published SCL-90 clinical case rule, classifying subjects with a consistent pattern of symptom elevations as clinical cases. The majority of subjects (80%) completed the screening in less than 30 minutes and reported little (15%) or no (84%) distress. Sixty-four percent believed it would help "very much" or "moderately" in getting to know them, and 35% thought it would help "slightly." On the SCL-90, 32 subjects (31.7%) had a positive screen, indicating significant psychological distress. All subjects with clinically significant symptoms on the BDI and SF-36 Mental Health Scale were cases on the SCL-90 (case-positive). Suicidal symptoms were reported in 13.9% of the sample, all of whom were SCL-90 cases. In a logistic regression model, subjects' dissatisfaction with physical appearance, poor physical health, and treatment with cranial radiation were associated with psychological distress. Results demonstrate that routine psychological screening can be successfully integrated into the cancer survivor clinic and may be effective in identifying those survivors with significant distress who require further evaluation.

Rapid clinical deterioration in an individual with Down syndrome.

PubMed

Jacobs, Julia; Schwartz, Alison; McDougle, Christopher J; Skotko, Brian G

2016-07-01

A small percentage of adolescents and young adults with Down syndrome experience a rapid and unexplained deterioration in cognitive, adaptive, and behavioral functioning. Currently, there is no standardized work-up available to evaluate these patients or treat them. Their decline typically involves intellectual deterioration, a loss of skills of daily living, and prominent behavioral changes. Certain cases follow significant life events such as completion of secondary school with friends who proceed on to college or employment beyond the individual with DS. Others develop this condition seemingly unprovoked. Increased attention in the medical community to clinical deterioration in adolescents and young adults with Down syndrome could provide a framework for improved diagnosis, evaluation, and treatment. This report presents a young adult male with Down syndrome who experienced severe and unexplained clinical deterioration, highlighting specific challenges in the systematic evaluation and treatment of these patients. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Plug-Assisted Retrograde Transvenous Obliteration for the Treatment of Gastric Varices: The Role of Intra-Procedural Cone-Beam Computed Tomography

PubMed Central

Ko, Gi-Young; Kwon, Young Baek; Yoon, Hyun-Ki; Sung, Kyu-Bo

2018-01-01

Objective To investigate the technical and clinical outcomes of plug-assisted retrograde transvenous obliteration (PARTO) for the treatment of gastric varices (GV) and to evaluate the role of intra-procedural cone-beam computed tomography (CBCT) performed during PARTO to confirm its technical success. Materials and Methods From January 2016 to December 2016, 17 patients with GV who had undergone PARTO were retrospectively evaluated. When the proximal part of the afferent vein was identified on a fluoroscopy, non-contrast CBCT images were obtained. In patients with incomplete embolization of GV, an additional injection of gelatin sponges was performed. Follow-up data from contrast-enhanced CT and upper intestinal endoscopy, as well as clinical and laboratory data were collected. Results Plug-assisted retrograde transvenous obliteration procedures were technically successful in all 17 patients. Complete embolization of GV was detected on CBCT images in 15 patients; whereas, incomplete embolization was detected in two. Complete embolization of GV was then achieved after an additional injection of gelatin sponges in these two patients as demonstrated on the 2nd CBCT image. The mean follow-up period after PARTO was 193 days (range, 73–383 days). A follow-up CT obtained 2–4 months after PARTO demonstrated marked shrinkage or complete obliteration of GV and portosystemic shunts in all 17 patients. There were no cases of variceal bleeding during the follow-up. Conclusion Plug-assisted retrograde transvenous obliteration is technically and clinically effective for the treatment of GV. In addition, intra-procedural CBCT can be an adjunct tool to fluoroscopy, because it can provide an immediate and accurate evaluation of the technical success of PARTO. PMID:29520179

The clinical and technical evaluation of a remote telementored telesonography system during the acute resuscitation and transfer of the injured patient.

PubMed

Dyer, Dianne; Cusden, Jane; Turner, Chris; Boyd, Jeff; Hall, Rob; Lautner, David; Hamilton, Douglas R; Shepherd, Lance; Dunham, Michael; Bigras, Andre; Bigras, Guy; McBeth, Paul; Kirkpatrick, Andrew W

2008-12-01

Ultrasound (US) has an ever increasing scope in the evaluation of trauma, but relies greatly on operator experience. NASA has refined telesongraphy (TS) protocols for traumatic injury, especially in reference to mentoring inexperienced users. We hypothesized that such TS might benefit remote terrestrial caregivers. We thus explored using real-time US and video communication between a remote (Banff) and central (Calgary) site during acute trauma resuscitations. A existing internet link, allowing bidirectional videoconferencing and unidirectional US transmission was used between the Banff and Calgary ERs. Protocols to direct or observe an extended focused assessment with sonography for trauma (EFAST) were adapted from NASA algorithms. A call rota was established. Technical feasibility was ascertained through review of completed checklists. Involved personnel were interviewed with a semistructured interview. In addition to three normal volunteers, 20 acute clinical examinations were completed. Technical challenges requiring solution included initiating US; audio and video communications; image freezing; and US transmission delays. FAST exams were completed in all cases and EFASTs in 14. The critical anatomic features of a diagnostic examination were identified in 98% of all FAST exams and a 100% of all EFASTs that were attempted. Enhancement of clinical care included confirmation of five cases of hemoperitoneum and two pneumothoraces (PTXs), as well as educational benefits. Remote personnel were appreciative of the remote direction particularly when instructions were given sequentially in simple, nontechnical language. The remote real-time guidance or observation of an EFAST using TS appears feasible. Most technical problems were quickly overcome. Further evaluation of this approach and technology is warranted in more remote settings with less experienced personnel.

Informed consent in oncology clinical trials: A Brown University Oncology Research Group prospective cross-sectional pilot study

PubMed Central

Schumacher, Andrew; Sikov, William M.; Quesenberry, Matthew I.; Safran, Howard; Khurshid, Humera; Mitchell, Kristen M.

2017-01-01

Background Informed consent forms (ICFs) for oncology clinical trials have grown increasingly longer and more complex. We evaluated objective understanding of critical components of informed consent among patients enrolling in contemporary trials of conventional or novel biologic/targeted therapies. Methods We evaluated ICFs for cancer clinical trials for length and readability, and patients registered on those studies were asked to complete a validated 14-question survey assessing their understanding of key characteristics of the trial. Mean scores were compared in groups defined by trial and patient characteristics. Results Fifty patients, of whom half participated in trials of immunotherapy or biologic/targeted agents and half in trials of conventional therapy, completed the survey. On average, ICFs for industry-originated trials (N = 9 trials) were significantly longer (P < .0001) and had lower Flesch ease-of-reading scores (P = .003) than investigator-initiated trials (N = 11). At least 80% of patients incorrectly responded to three key questions which addressed the experimental nature of their trial therapy, its purported efficacy and potential risks relative to alternative treatments. The mean objective understanding score was 76.9±8.8, but it was statistically significantly lower for patients who had not completed high school (P = .011). The scores did not differ significantly by type of cancer therapy (P = .12) or trial sponsor (P = .38). Conclusions Many participants enrolled on cancer trials had poor understanding of essential elements of their trial. In order to ensure true informed consent, innovative approaches, such as expanded in-person counseling adapted to the patient’s education level or cultural characteristics should be evaluated across socio-demographic groups. Trial registration Clinicaltrials.gov NCT01772511 PMID:28235011

A novel clinical decision support algorithm for constructing complete medication histories.

PubMed

Long, Ju; Yuan, Michael Juntao

2017-07-01

A patient's complete medication history is a crucial element for physicians to develop a full understanding of the patient's medical conditions and treatment options. However, due to the fragmented nature of medical data, this process can be very time-consuming and often impossible for physicians to construct a complete medication history for complex patients. In this paper, we describe an accurate, computationally efficient and scalable algorithm to construct a medication history timeline. The algorithm is developed and validated based on 1 million random prescription records from a large national prescription data aggregator. Our evaluation shows that the algorithm can be scaled horizontally on-demand, making it suitable for future delivery in a cloud-computing environment. We also propose that this cloud-based medication history computation algorithm could be integrated into Electronic Medical Records, enabling informed clinical decision-making at the point of care. Copyright © 2017 Elsevier B.V. All rights reserved.

The protective scale of the Armidilo-S: The importance of forensic and clinical outcomes.

PubMed

Lindsay, William R; Steptoe, Lesley R; Haut, Fabian; Miller, Sandra; Macer, Jane; McVicker, Ronnie

2018-05-15

The Armidilo has two scales-the risk scale and the protective scale. Research has been confined to the risk scale which appears to predict future incidents with medium to large effect sizes. There have been no publications on the use of the protective scale. The Armidilo was completed on four individuals with IDD who were either moving on from their placement or whose placement was in jeopardy because of new information or altered policies in the organization. The Armidilo was completed in the usual fashion. Risk and protective results show that for each individual, recommendations could be made that ensured the best outcome. For two participants, restrictive placements were avoided because of the data on protective factors. The protective scale can be a powerful support for the clinician's case in offenders with IDD. The protective scale should be completed routinely for clinical evaluation. © 2018 John Wiley & Sons Ltd.

The effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model.

PubMed

Maddineshat, Maryam; Hashemi, Mitra; Besharati, Reza; Gholami, Sepideh; Ghavidel, Fatemeh

2018-01-01

Clinical experience associated with the fear and anxiety of nursing students in the psychiatric unit. Mental health nursing instructors find it challenging to teach nursing students to deal with patients with mental disorders in an environment where they need to provide patient teaching and clinical decision-making based on evidence and new technology. To measure the effectiveness of clinical teaching of mental health courses in nursing using clinical supervision and Kirkpatrick's model evaluation in the psychiatry unit of Imam Reza Hospital, Bojnurd, Iran. This cross-sectional study was carried out from 2011 to 2016 on 76 nursing students from a university as part of a clinical mental health course in two semesters. The students were selected by a non-probable convenient sampling method. After completing their clinical education, each student responded to checklist questions based on the four-level Kirkpatrick's model evaluation and open questions relating to clinical supervision. Finally, all data was analyzed using the SPSS version 16. The students have evaluated clinical supervision as a useful approach, and appreciated the instructor's supportive behavior during teaching and imparting clinical skills. This has made them feel relaxed at the end of the clinical teaching course. In addition, in the evaluation through Kirkpatrick's model, more than 70% of the students have been satisfied with the method of conducting the teaching and average score of nursing students' attitude toward mental health students: Their mean self-confidence score was 18.33±1.69, and the mean score of their performance in the study was evaluated to be 93.74±5.3 from 100 points. The results of clinical mental health teaching through clinical supervision and Kirkpatrick's model evaluation show that the satisfaction, self-esteem, attitude, and skill of nursing students are excellent, thereby portraying the effectiveness of clinical teaching. But this program still needs to be reformed. To establish long-term goals and obtain knowledge and clinical skills of nursing, it is recommended to develop a curriculum and evaluate it appropriately.

Dichotomous scoring of Trails B in patients referred for a dementia evaluation.

PubMed

Schmitt, Andrew L; Livingston, Ronald B; Smernoff, Eric N; Waits, Bethany L; Harris, James B; Davis, Kent M

2010-04-01

The Trail Making Test is a popular neuropsychological test and its interpretation has traditionally used time-based scores. This study examined an alternative approach to scoring that is simply based on the examinees' ability to complete the test. If an examinee is able to complete Trails B successfully, they are coded as "completers"; if not, they are coded as "noncompleters." To assess this approach to scoring Trails B, the performance of 97 diagnostically heterogeneous individuals referred for a dementia evaluation was examined. In this sample, 55 individuals successfully completed Trails B and 42 individuals were unable to complete it. Point-biserial correlations indicated a moderate-to-strong association (r(pb)=.73) between the Trails B completion variable and the Total Scale score of the Repeatable Battery for the Assessment of Neurological Status (RBANS), which was larger than the correlation between the Trails B time-based score and the RBANS Total Scale score (r(pb)=.60). As a screen for dementia status, Trails B completion showed a sensitivity of 69% and a specificity of 100% in this sample. These results suggest that dichotomous scoring of Trails B might provide a brief and clinically useful measure of dementia status.

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

PubMed Central

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

2011-01-01

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

Transepidermal drug delivery: a new treatment option for areata alopecia?

PubMed

Issa, Maria Claudia Almeida; Pires, Marianna; Silveira, Priscilla; Xavier de Brito, Esther; Sasajima, Cristiane

2015-02-01

Transepidermal drug delivery (TED) is a new potential method in dermatology. Permeability alterations induced by ablative fractional resurfacing have been described with the aim to increasing the delivery of different substances into the skin. To evaluate clinical response and side effects of TED in areata alopecia (AA) treatment using ablative fractional methods associated with acoustic pressure ultrasound (US) to deliver triamcinolone solution into the skin. Five cases of AA underwent treatment which comprised of 3 steps: 1) Ablative fractioned RF or CO2 laser 2) topical application of triamcinolone 3) acoustic pressure wave US. The number of sessions varied according to the clinical response, ranging from one to six sessions. All patients had complete recovery of the area treated. Two of them treated with ablative fractional RF + triamcinolone + US had complete response after three and six sessions. The other two treated with ablative fractional CO2 + triamcinolone + US had complete response after one session. Fractioned ablative resurfacing associated with acoustic pressure wave US is a new option to areata alopecia treatment with good clinical result and low incidence of side effects.

Reasons for Non-Completion of Health Related Quality of Life Evaluations in Pediatric Acute Myeloid Leukemia: A Report from the Children’s Oncology Group

PubMed Central

Johnston, Donna L.; Nagarajan, Rajaram; Caparas, Mae; Schulte, Fiona; Cullen, Patricia; Aplenc, Richard; Sung, Lillian

2013-01-01

Background Health related quality of life (HRQL) assessments during therapy for pediatric cancer are important. The objective of this study was to describe reasons for failure to provide HRQL assessments during a pediatric acute myeloid leukemia (AML) clinical trial. Methods We focused on HRQL assessments embedded in a multicenter pediatric AML clinical trial. The PedsQL 4.0 Generic Core Scales, PedsQL 3.0 Acute Cancer Module, PedsQL Multidimensional Fatigue Scale, and Pediatric Inventory for Parents were obtained from parent/guardian respondents at a maximum of six time points. Children provided self-report optionally. A central study coordinator contacted sites with delinquent HRQL data. Reasons for failure to submit the HRQL assessments were evaluated by three pediatric oncologists and themes were generated using thematic analysis. Results There were 906 completed and 1091 potential assessments included in this analysis (83%). The median age of included children was 12.9 years (range 2.0 to 18.9). The five themes for non-completion were: patient too ill; passive or active refusal by respondent; developmental delay; logistical challenges; and poor knowledge of study processes from both the respondent and institutional perspective. Conclusions We identified reasons for non-completion of HRQL assessments during active therapy. This information will facilitate recommendations to improve study processes and future HRQL study designs to maximize response rates. PMID:24040278

[Diagnostic value of a predictive model for complete ruptures of the rotator cuff associated to subacromial impingement].

PubMed

Águila-Ledesma, I R; Córdova-Fonseca, J L; Medina-Pontaza, O; Núñez-Gómez, D A; Calvache-García, C; Pérez-Atanasio, J M; Torres-González, R

2017-01-01

Pathology related to the rotator cuff remains among the most prevalent musculoskeletal diseases. There is an increasing need for imaging studies (MRI, US, arthroscopy) to test the diagnostic performance of the medical history and physical examination. To prove the diagnostic value of a clinical-radiographic predictive model to find complete ruptures of the rotator cuff. Descriptive, observational, prospective, transversal and analytical study. Fifty-five patients with preoperative shoulder pain were evaluated with 13 predictive variables: age > 50 years, nocturnal pain, muscle weakness, clinical signs of Neer, Hawkins, Jobe, external rotation lag (ERLS), belly-press, bear hug, and lift-off, radiographic measurement of subacromial space, acromial index and critical shoulder angle. Sensitivity, specificity, and positive and negative predictive values were measured in each variable, comparing the results of each one against the postoperative findings. Of the 55 patients evaluated, 42 had a complete rupture of the rotator cuff in the postoperative period. The eight variables with a higher diagnostic value were selected and a ROC curve was performed, providing an area under the curve of 0.88. This predictive model uses eight variables (age > 50 years, nocturnal pain, muscle weakness, Jobe, Hawkins, ERLS, subacromial space ≤ 6 mm, and critical shoulder angle > 35°), which together add the predictive value of 0.88 (AUC) to diagnose complete ruptures of the supraspinatus tendon.

[Clinical management of adrenal incidentalomas: results of a survey].

PubMed

Moreno-Fernández, Jesús; García-Manzanares, Alvaro; Sánchez-Covisa, Miguel Aguirre; García, E Inés Rosa Gómez

2009-12-01

Incidentalomas are clinically silent adrenal masses that are discovered incidentally during diagnostic testing for clinical conditions unrelated to suspicion of adrenal disease. Several decision algorithms are used in the management of adrenal masses. We evaluated the routine use of these algorithms through a clinical activity questionnaire. The questionnaire included data on the work center, initial hormonal and radiological study, imaging and hormonal tests performed to complete the study, surgical indications and clinical follow-up. Thirty-three endocrinologists (79%) attending the annual congress of the Castilla-La Mancha Society of Endocrinology, Nutrition and Diabetes completed the questionnaire. Forty-six percent considered tumoral size to be the most important factor suggesting malignancy in the initial evaluation of adrenal incidentalomas, the limit being 4 cm for 78% of the endocrinologists. Imaging study was completed by magnetic resonance imaging by 39%. All the physicians always performed screening for hypercortisolism and pheochromocytoma. Other assessments always conducted in all incidentalomas included hyperaldosteronism (76%), sex hormone-producing tumor (51%) and congenital adrenal hyperplasia (30%). Seventy-nine percent of respondents began to refer incidentalomas larger than 4 cm for surgical treatment, and 46% referred all tumors larger than 6 cm for surgical treatment. With regard to hormonal function, patients with pheochromocytoma, Cushing's syndrome, hyperaldosteronism with poorly controlled blood pressure or sex hormoneproducing tumors were more frequently referred for surgery. Seventy-six percent of endocrinologists performed clinical follow-up in adrenal incidentalomas larger than 4 cm, preferably through computerized tomography (81%), and repeated studies for hormonal hypercortisolism (97%), primary hyperaldosteronism (42%) and pheochromocytoma (76%) over a 4-5 year period (67%). Clinical practice varied among the endocrinologists surveyed, although a certain uniformity in relation to the main guidelines was observed. A tendency to request a greater number of diagnostic tests for initial hormone assessment and clinical follow-up was detected. Assessment, decision-making and medical monitoring in adrenal incidentalomas remain unclear and consequently further studies are required. Copyright 2009 Sociedad Española de Endocrinología y Nutrición. Published by Elsevier Espana. All rights reserved.

The effectiveness of an e-learning program on pediatric medication safety for undergraduate students: a pretest-post-test intervention study.

PubMed

Lee, Tzu-Ying; Lin, Fang-Yi

2013-04-01

Safe medication management is a major competency taught in the nursing curriculum. However, administering pediatric medications is considered a common clinical stressor for Taiwanese students. A supplemental e-learning program that helps students fill the gap between basic nursing skills and pediatric knowledge on medication safety was developed. To evaluate the effectiveness of an e-learning program to increase pediatric medication management among students who take pediatric nursing courses. This intervention study used a historical comparison design. A university in Northern Taiwan. A total of 349 undergraduate nursing students who took pediatric nursing courses participated. Eighty students in the comparison group received regular pediatric courses, including the lectures and clinical practicum; 269 students in the intervention group received an e-learning program, in addition to the standard pediatric courses. Between February 2011 and July 2012 pediatric medication management, including pediatric medication knowledge and calculation ability, was measured at the beginning of the first class, at the completion of the lectures, and at the completion of the clinical practicum. The program was evaluated qualitatively and quantitatively. The intervention group had significantly higher pediatric medication management scores at completion of the lecture course and at the completion of the clinical practicum than the comparison group based on the first day of the lecture course, after adjusting for age, nursing program, and having graduated from a junior college in nursing. Overall, the students appreciated the program that included various teaching modalities content that related to the administration of medication. Using an e-learning program on pediatric medication management is an effective learning method in addition to sitting in a regular lecture course. The different emphases in each module, provided by experienced instructors, enabled the students to be more aware of their role in pediatric medication safety. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)

PubMed Central

Huang, Hongyun; Young, Wise; Chen, Lin; Feng, Shiqing; Zoubi, Ziad M. Al; Sharma, Hari Shanker; Saberi, Hooshang; Moviglia, Gustavo A.; He, Xijing; Muresanu, Dafin F.; Sharma, Alok; Otom, Ali; Andrews, Russell J.; Al-Zoubi, Adeeb; Bryukhovetskiy, Andrey S.; Chernykh, Elena R.; Domańska-Janik, Krystyna; Jafar, Emad; Johnson, W. Eustace; Li, Ying; Li, Daqing; Luan, Zuo; Mao, Gengsheng; Shetty, Ashok K.; Siniscalco, Dario; Skaper, Stephen; Sun, Tiansheng; Wang, Yunliang; Wiklund, Lars; Xue, Qun; You, Si-Wei; Zheng, Zuncheng; Dimitrijevic, Milan R.; Masri, W. S. El; Sanberg, Paul R.; Xu, Qunyuan; Luan, Guoming; Chopp, Michael; Cho, Kyoung-Suok; Zhou, Xin-Fu; Wu, Ping; Liu, Kai; Mobasheri, Hamid; Ohtori, Seiji; Tanaka, Hiroyuki; Han, Fabin; Feng, Yaping; Zhang, Shaocheng; Lu, Yingjie; Zhang, Zhicheng; Rao, Yaojian; Tang, Zhouping; Xi, Haitao; Wu, Liang; Shen, Shunji; Xue, Mengzhou; Xiang, Guanghong; Guo, Xiaoling; Yang, Xiaofeng; Hao, Yujun; Hu, Yong; Li, Jinfeng; AO, Qiang; Wang, Bin; Zhang, Zhiwen; Lu, Ming; Li, Tong

2018-01-01

Cell therapy has been shown to be a key clinical therapeutic option for central nervous system diseases or damage. Standardization of clinical cell therapy procedures is an important task for professional associations devoted to cell therapy. The Chinese Branch of the International Association of Neurorestoratology (IANR) completed the first set of guidelines governing the clinical application of neurorestoration in 2011. The IANR and the Chinese Association of Neurorestoratology (CANR) collaborated to propose the current version “Clinical Cell Therapy Guidelines for Neurorestoration (IANR/CANR 2017)”. The IANR council board members and CANR committee members approved this proposal on September 1, 2016, and recommend it to clinical practitioners of cellular therapy. These guidelines include items of cell type nomenclature, cell quality control, minimal suggested cell doses, patient-informed consent, indications for undergoing cell therapy, contraindications for undergoing cell therapy, documentation of procedure and therapy, safety evaluation, efficacy evaluation, policy of repeated treatments, do not charge patients for unproven therapies, basic principles of cell therapy, and publishing responsibility. PMID:29637817

Suicide risk in patients with anxiety disorders: a meta-analysis of the FDA database.

PubMed

Khan, Arif; Leventhal, Robyn M; Khan, Shirin; Brown, Walter A

2002-04-01

Previous reports of suicide risk in patients with anxiety disorders have been inconsistent. Using the FDA database, we assessed suicide and suicide attempt risk among patients, participating in recent clinical trials evaluating new anti-anxiety medications, with diagnosis of panic disorder (PD), social anxiety disorder or social phobia (SP), generalized anxiety disorder (GAD), post traumatic stress disorder (PTSD), and obsessive compulsive disorder (OCD). Overall, among 20076 participating anxious patients, 12 committed suicide and 28 attempted suicide. The annual suicide risk rate was 193/100000 patients and annual suicide attempt risk was 1350/100000 patients. Clinical trial data have limited applicability to clinical practice. Participants in clinical trials are a highly selected, nonrepresentative sample of the clinical population. A number of patients never complete clinical trials and thus data are based on a limited sub-sample. These trials were not primarily designed to assess suicide risk. Suicide risk in patients with anxiety disorders is higher than previously thought. Patients with anxiety disorders warrant explicit evaluation for suicide risk.

Evaluation of User Interface and Workflow Design of a Bedside Nursing Clinical Decision Support System

PubMed Central

Yuan, Michael Juntao; Finley, George Mike; Mills, Christy; Johnson, Ron Kim

2013-01-01

Background Clinical decision support systems (CDSS) are important tools to improve health care outcomes and reduce preventable medical adverse events. However, the effectiveness and success of CDSS depend on their implementation context and usability in complex health care settings. As a result, usability design and validation, especially in real world clinical settings, are crucial aspects of successful CDSS implementations. Objective Our objective was to develop a novel CDSS to help frontline nurses better manage critical symptom changes in hospitalized patients, hence reducing preventable failure to rescue cases. A robust user interface and implementation strategy that fit into existing workflows was key for the success of the CDSS. Methods Guided by a formal usability evaluation framework, UFuRT (user, function, representation, and task analysis), we developed a high-level specification of the product that captures key usability requirements and is flexible to implement. We interviewed users of the proposed CDSS to identify requirements, listed functions, and operations the system must perform. We then designed visual and workflow representations of the product to perform the operations. The user interface and workflow design were evaluated via heuristic and end user performance evaluation. The heuristic evaluation was done after the first prototype, and its results were incorporated into the product before the end user evaluation was conducted. First, we recruited 4 evaluators with strong domain expertise to study the initial prototype. Heuristic violations were coded and rated for severity. Second, after development of the system, we assembled a panel of nurses, consisting of 3 licensed vocational nurses and 7 registered nurses, to evaluate the user interface and workflow via simulated use cases. We recorded whether each session was successfully completed and its completion time. Each nurse was asked to use the National Aeronautics and Space Administration (NASA) Task Load Index to self-evaluate the amount of cognitive and physical burden associated with using the device. Results A total of 83 heuristic violations were identified in the studies. The distribution of the heuristic violations and their average severity are reported. The nurse evaluators successfully completed all 30 sessions of the performance evaluations. All nurses were able to use the device after a single training session. On average, the nurses took 111 seconds (SD 30 seconds) to complete the simulated task. The NASA Task Load Index results indicated that the work overhead on the nurses was low. In fact, most of the burden measures were consistent with zero. The only potentially significant burden was temporal demand, which was consistent with the primary use case of the tool. Conclusions The evaluation has shown that our design was functional and met the requirements demanded by the nurses’ tight schedules and heavy workloads. The user interface embedded in the tool provided compelling utility to the nurse with minimal distraction. PMID:23612350

Implementing a geriatric assessment in cooperative group clinical cancer trials: CALGB 360401.

PubMed

Hurria, Arti; Cirrincione, Constance T; Muss, Hyman B; Kornblith, Alice B; Barry, William; Artz, Andrew S; Schmieder, Linda; Ansari, Rafat; Tew, William P; Weckstein, Douglas; Kirshner, Jeffrey; Togawa, Kayo; Hansen, Kurt; Katheria, Vani; Stone, Richard; Galinsky, Ilene; Postiglione, John; Cohen, Harvey Jay

2011-04-01

Factors captured in a geriatric assessment can predict morbidity and mortality in older adults, but are not routinely measured in cancer clinical trials. This study evaluated the implementation of a geriatric assessment tool in the cooperative group setting. Patients age ≥ 65 with cancer, who enrolled on cooperative group cancer trials, were eligible to enroll on Cancer and Leukemia Group B (CALGB) 360401. They completed a geriatric assessment tool before initiation of protocol therapy, consisting of valid and reliable geriatric assessment measures which are primarily self-administered and require minimal resources and time by healthcare providers. The assessment measures functional status, comorbidity, cognitive function, psychological state, social support, and nutritional status. The protocol specified criteria for incorporation of the tool in future cooperative group trials was based on the time to completion and percent of patients who could complete their portion without assistance. Patient satisfaction with the tool was captured. Of the 93 patients who enrolled in this study, five (5%) met criteria for cognitive impairment and three did not complete the cognitive screen, leaving 85 assessable patients (median age, 72 years). The median time to complete the geriatric assessment tool was 22 minutes, 87% of patients (n = 74) completed their portion without assistance, 92% (n = 78) were satisfied with the questionnaire length, 95% (n = 81) reported no difficult questions, and 96% (n = 82) reported no upsetting questions. One hundred percent of health care professionals completed their portion. This brief, primarily self-administered geriatric assessment tool met the protocol specified criteria for inclusion in future cooperative group clinical trials.

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 of complex roles and interventions in health care outcomes and service delivery. Case study design is an appropriate methodology to use when study outcomes relate to clinical practice.

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early-Phase Pediatric Oncology Clinical Trial: A Pilot Study.

PubMed

Crane, Stacey; Backus, Lori; Stockman, Beth; Carpenter, Janet S; Lin, Li; Haase, Joan

Early-phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention and completion of measures. Measures completed included the following: demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition.

Understanding Treatment Burden and Quality of Life Impact of Participating in an Early Phase Pediatric Oncology Clinical Trial: A Pilot Study

PubMed Central

BACKUS, LORI; STOCKMAN, BETH; CARPENTER, JANET S.; LIN, LI; HAASE, JOAN

2017-01-01

Purpose Early phase clinical trials (EPTs) have led to new, more effective treatment options for children with cancer. Despite the extensive use of EPTs in pediatric oncology, little is known about parent and child experiences during EPT participation. The purposes of this pilot study were to assess the feasibility and preliminary results of having children with cancer and their parents complete measures of treatment burden and quality of life (QOL) concurrent with EPT participation. Methods In this descriptive, longitudinal, pilot study, parents and children were followed for the first 60 days of an EPT. Feasibility was assessed by participant enrollment and retention, and completion of measures. Measures completed included: Demographic form (completed at baseline); Diary of Trial Experiences to capture treatment burden (completed ongoing); and PedsQL™ Quality of Life Inventories, Cancer Modules, and Family Impact Module (completed at baseline, post-first disease evaluation, and off-study). Data were analyzed using descriptive statistics. Results Feasibility goals of enrollment, retention, and measure completion were partially met. Preliminary treatment burden and QOL results are provided. Conclusions While QOL assessments may provide insight into EPT experiences, future studies need to be conducted at multiple sites and enrollment goals must account for participant attrition. PMID:28849701

Student assessment by objective structured examination in a neurology clerkship

PubMed Central

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

2012-01-01

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

Gastric varices and hepatic encephalopathy: treatment with vascular plug and gelatin sponge-assisted retrograde transvenous obliteration--a primary report.

PubMed

Gwon, Dong Il; Ko, Gi-Young; Yoon, Hyun-Ki; Sung, Kyu-Bo; Kim, Jin Hyoung; Shin, Ji Hoon; Ko, Heung Kyu; Song, Ho-Young

2013-07-01

To evaluate technical safety, clinical safety, and effectiveness of vascular plug-assisted retrograde transvenous obliteration (RTO) for treatment of gastric varices (GV) and hepatic encephalopathy (HE). This retrospective study was approved by the institutional review board; written informed consent was waived. From April 2009 to December 2011, 20 patients (13, GV; seven, HE) who had undergone vascular plug-assisted RTO were retrospectively evaluated. After retrograde transvenous placement of a vascular plug in the left adrenal vein or gastrorenal shunt, subsequent gelatin-sponge embolization of both gastrorenal shunt and GV was performed. Follow-up computed tomography (CT) and upper gastrointestinal tract endoscopy were performed; clinical and laboratory data were collected to evaluate primary (technical success, complications, clinical success) and secondary (change of liver function by using the Child-Pugh score, worsening of esophageal varices) end points. Laboratory data before and after vascular plug-assisted RTO were compared (paired-sample t test). Placement of the vascular plug and subsequent gelatin-sponge embolization were technically successful in all 20 patients, with no procedure-related complications. Follow-up CT within 1 week after vascular plug-assisted RTO showed complete thrombosis of GV and gastrorenal shunts in all patients. Clinical symptoms of HE completely resolved in all seven patients with HE; mean serum NH3 level of 127.4 μmol/L ± 58 (standard deviation) before vascular plug-assisted RTO decreased significantly to 28.1 μmol/L ± 9.8 within 1 week after vascular plug-assisted RTO (P = .002). Eighteen patients who underwent follow-up longer than 2 months showed complete obliteration of GV and gastrorenal shunts at CT and endoscopy. There were no cases of variceal bleeding or HE during mean follow-up of 422 days. Improvement in Child-Pugh score was observed in 12 of 18 (67%) patients 1 month after vascular plug-assisted RTO. Worsening of esophageal varices was observed in four (22%) patients at mean follow-up of 9.4 months. Vascular plug-assisted RTO is technically simple and safe and seems to be clinically effective for treatment of GV and HE.

Outcomes of laparoscopic fertility-sparing surgery in clinically early-stage epithelial ovarian cancer.

PubMed

Park, Jin-Young; Heo, Eun Jin; Lee, Jeong-Won; Lee, Yoo-Young; Kim, Tae-Joong; Kim, Byoung-Gie; Bae, Duk-Soo

2016-03-01

Fertility-sparing surgery (FSS) is becoming an important technique in the surgical management of young women with early-stage epithelial ovarian cancer (EOC). We retrospectively evaluated the outcome of laparoscopic FSS in presumed clinically early-stage EOC. We retrospectively searched databases of patients who received laparoscopic FSS for EOC between January 1999 and December 2012 at Samsung Medical Center. Women aged ≤40 years were included. The perioperative, oncological, and obstetric outcomes of these patients were evaluated. A total of 18 patients was evaluated. The median age of the patients was 33.5 years (range, 14 to 40 years). The number of patients with clinically stage IA and IC was 6 (33.3%) and 12 (66.7%), respectively. There were 7 (38.9%), 5 (27.8%), 3 (16.7%), and 3 patients (16.7%) with mucinous, endometrioid, clear cell, and serous tumor types, respectively. Complete surgical staging to preserve the uterus and one ovary with adnexa was performed in 4 patients (22.2%). Two out of them were upstaged to The International Federation of Gynecology and Obstetrics stage IIIA1. During the median follow-up of 47.3 months (range, 11.5 to 195.3 months), there were no perioperative or long term surgical complications. Four women (22.2%) conceived after their respective ovarian cancer treatments. Three (16.7%) of them completed full-term delivery and one is expecting a baby. One patient had disease recurrence. No patient died of the disease. FSS in young patients with presumed clinically early-stage EOC is a challenging and cautious procedure. Further studies are urgent to determine the safety and feasibility of laparoscopic FSS in young patients with presumed clinically early-stage EOC.

Outcomes of laparoscopic fertility-sparing surgery in clinically early-stage epithelial ovarian cancer

PubMed Central

Park, Jin-Young; Lee, Yoo-Young; Kim, Tae-Joong; Kim, Byoung-Gie; Bae, Duk-Soo

2016-01-01

Objective Fertility-sparing surgery (FSS) is becoming an important technique in the surgical management of young women with early-stage epithelial ovarian cancer (EOC). We retrospectively evaluated the outcome of laparoscopic FSS in presumed clinically early-stage EOC. Methods We retrospectively searched databases of patients who received laparoscopic FSS for EOC between January 1999 and December 2012 at Samsung Medical Center. Women aged ≤40 years were included. The perioperative, oncological, and obstetric outcomes of these patients were evaluated. Results A total of 18 patients was evaluated. The median age of the patients was 33.5 years (range, 14 to 40 years). The number of patients with clinically stage IA and IC was 6 (33.3%) and 12 (66.7%), respectively. There were 7 (38.9%), 5 (27.8%), 3 (16.7%), and 3 patients (16.7%) with mucinous, endometrioid, clear cell, and serous tumor types, respectively. Complete surgical staging to preserve the uterus and one ovary with adnexa was performed in 4 patients (22.2%). Two out of them were upstaged to The International Federation of Gynecology and Obstetrics stage IIIA1. During the median follow-up of 47.3 months (range, 11.5 to 195.3 months), there were no perioperative or long term surgical complications. Four women (22.2%) conceived after their respective ovarian cancer treatments. Three (16.7%) of them completed full-term delivery and one is expecting a baby. One patient had disease recurrence. No patient died of the disease. Conclusion FSS in young patients with presumed clinically early-stage EOC is a challenging and cautious procedure. Further studies are urgent to determine the safety and feasibility of laparoscopic FSS in young patients with presumed clinically early-stage EOC. PMID:26768783

Improvised Neutral Zone Technique in a Completely Edentulous Patient with an Atrophic Mandibular Ridge and Neuromuscular Incoordination: A Clinical Tip

PubMed Central

Thirumalai Thangarajan, Saravanan; Mani, Umamaheswari; Kumar V, Anand

2017-01-01

Resorption of mandibular ridges is a multifactorial and biomechanical disease that is chronic, progressive, irreversible, and cumulative leading to loss of sulcular depth, vertical dimension loss, and decreased lower facial height. Some common neurological, hormonal, and metabolic disorders affect the adaptability of dentures, and this can be diagnosed by a trained prosthodontist with proper history-taking and clinical examination.The denture becomes passive due to complex neuromuscular control and causes difficulties in impression-making, mastication, and swallowing, which in turn leads to loss of retention and stability in complete dentures. Hence, residual ridge resorption becomes a challenging scenario for a clinician during fabrication of complete dentures. The neutral zone concept plays a significant role in overcoming these challenges. The neutral zone is the area where the outward forces from the tongue are neutralized or nullified by the forces of the lips and cheeks acting inward during functional movements.The neutral zone technique is an alternative approach for the construction of lower complete dentures. It is most effective for dentures where there is a highly atrophic ridge and history of denture instability. The technique aims to construct a denture that is shaped by muscle function and is in harmony with the surrounding oral structures. The technique is by no means new, but it is a valuable one. It is rarely used because of the extra clinical step involved and its complexity. Complete and partial denture failures are often related to non-compliance with neutral zone factors. Thus, the evaluation of the neutral zone is an important factor. Increased retention and stability with reduced chairside time are the salient features of this new approach to any clinically challenging situation in complete dentures.This clinical report describes a modification of the conventional neutral zone technique using improvised procedures to minimize chairside visits for a patient with an atrophic mandibular ridge and neuromuscular incoordination. PMID:28553567

Improvised Neutral Zone Technique in a Completely Edentulous Patient with an Atrophic Mandibular Ridge and Neuromuscular Incoordination: A Clinical Tip.

PubMed

Saravanakumar, Prathibha; Thirumalai Thangarajan, Saravanan; Mani, Umamaheswari; Kumar V, Anand

2017-04-24

Resorption of mandibular ridges is a multifactorial and biomechanical disease that is chronic, progressive, irreversible, and cumulative leading to loss of sulcular depth, vertical dimension loss, and decreased lower facial height. Some common neurological, hormonal, and metabolic disorders affect the adaptability of dentures, and this can be diagnosed by a trained prosthodontist with proper history-taking and clinical examination.The denture becomes passive due to complex neuromuscular control and causes difficulties in impression-making, mastication, and swallowing, which in turn leads to loss of retention and stability in complete dentures. Hence, residual ridge resorption becomes a challenging scenario for a clinician during fabrication of complete dentures. The neutral zone concept plays a significant role in overcoming these challenges. The neutral zone is the area where the outward forces from the tongue are neutralized or nullified by the forces of the lips and cheeks acting inward during functional movements.The neutral zone technique is an alternative approach for the construction of lower complete dentures. It is most effective for dentures where there is a highly atrophic ridge and history of denture instability. The technique aims to construct a denture that is shaped by muscle function and is in harmony with the surrounding oral structures. The technique is by no means new, but it is a valuable one. It is rarely used because of the extra clinical step involved and its complexity. Complete and partial denture failures are often related to non-compliance with neutral zone factors. Thus, the evaluation of the neutral zone is an important factor. Increased retention and stability with reduced chairside time are the salient features of this new approach to any clinically challenging situation in complete dentures.This clinical report describes a modification of the conventional neutral zone technique using improvised procedures to minimize chairside visits for a patient with an atrophic mandibular ridge and neuromuscular incoordination.

Impact of a new vaccine clinic on hepatitis B vaccine completion and immunological response rates in an HIV-positive cohort.

PubMed

Rock, Clare; de Barra, Eoghan; Sadlier, Corinna; Kelly, Sinead; Dowling, Catherine; McNally, Cora; Bergin, Colm

2013-06-01

Hepatitis B virus vaccination (HBVV) in the HIV-infected population has poor reported completion rates and immunological response rates. At our HIV clinic, we established a vaccine clinic to improve HBVV outcomes using interventions such as SMS text reminders and double-dose (DD) HBVV for standard-dose non-responders (SD NRs). A five-year (2003-2008) retrospective review of the completion rates and immunological response rates for HBVV after the establishment of the dedicated vaccine clinic was conducted. Statistical significance was assumed at p<0.05, and the analysis was performed using SPSS (v16). A total of 354 HIV-infected patients were included. Seventy-five percent (268/354) of patients completed the SD HBVV, an 84% (226/268) returned for the hepatitis B surface antibody evaluation. Only 47.3% (107/226) responded to standard-dose hepatitis B vaccination. Responders had higher absolute numbers (p=0.017) and percentages of CD4 cells (p<0.001) and were more likely to be receiving HAART (p=0.001). There was a 70% (48/69) response rate to DD HBVV among SD NRs. On-treatment analysis showed an 88% (155/176) overall immunological response to SD HBVV and DD HBVV, if required. High HBVV completion and response rates in this HIV cohort were enabled through the use of multiple interventions, including the use of SMS text message reminders and routine referral for DD vaccination. Copyright © 2012 King Saud Bin Abdulaziz University for Health Sciences. Published by Elsevier Ltd. All rights reserved.

Evaluating a mobile application for improving clinical laboratory test ordering and diagnosis.

PubMed

Meyer, Ashley N D; Thompson, Pamela J; Khanna, Arushi; Desai, Samir; Mathews, Benji K; Yousef, Elham; Kusnoor, Anita V; Singh, Hardeep

2018-04-20

Mobile applications for improving diagnostic decision making often lack clinical evaluation. We evaluated if a mobile application improves generalist physicians' appropriate laboratory test ordering and diagnosis decisions and assessed if physicians perceive it as useful for learning. In an experimental, vignette study, physicians diagnosed 8 patient vignettes with normal prothrombin times (PT) and abnormal partial thromboplastin times (PTT). Physicians made test ordering and diagnosis decisions for 4 vignettes using each resource: a mobile app, PTT Advisor, developed by the Centers for Disease Control and Prevention (CDC)'s Clinical Laboratory Integration into Healthcare Collaborative (CLIHC); and usual clinical decision support. Then, physicians answered questions regarding their perceptions of the app's usefulness for diagnostic decision making and learning using a modified Kirkpatrick Training Evaluation Framework. Data from 368 vignettes solved by 46 physicians at 7 US health care institutions show advantages for using PTT Advisor over usual clinical decision support on test ordering and diagnostic decision accuracy (82.6 vs 70.2% correct; P < .001), confidence in decisions (7.5 vs 6.3 out of 10; P < .001), and vignette completion time (3:02 vs 3:53 min.; P = .06). Physicians reported positive perceptions of the app's potential for improved clinical decision making, and recommended it be used to address broader diagnostic challenges. A mobile app, PTT Advisor, may contribute to better test ordering and diagnosis, serve as a learning tool for diagnostic evaluation of certain clinical disorders, and improve patient outcomes. Similar methods could be useful for evaluating apps aimed at improving testing and diagnosis for other conditions.

Using Data Augmentation to Facilitate Conduct of Phase I–II Clinical Trials with Delayed Outcomes

PubMed Central

Jin, Ick Hoon; Liu, Suyu; Thall, Peter F.; Yuan, Ying

2014-01-01

A practical impediment in adaptive clinical trials is that outcomes must be observed soon enough to apply decision rules to choose treatments for new patients. For example, if outcomes take up to six weeks to evaluate and the accrual rate is one patient per week, on average three new patients will be accrued while waiting to evaluate the outcomes of the previous three patients. The question is how to treat the new patients. This logistical problem persists throughout the trial. Various ad hoc practical solutions are used, none entirely satisfactory. We focus on this problem in phase I–II clinical trials that use binary toxicity and efficacy, defined in terms of event times, to choose doses adaptively for successive cohorts. We propose a general approach to this problem that treats late-onset outcomes as missing data, uses data augmentation to impute missing outcomes from posterior predictive distributions computed from partial follow-up times and complete outcome data, and applies the design’s decision rules using the completed data. We illustrate the method with two cancer trials conducted using a phase I–II design based on efficacy-toxicity trade-offs, including a computer stimulation study. PMID:25382884

Laryngeal and pharyngeal dysfunction in horses homozygous for hyperkalemic periodic paralysis.

PubMed

Carr, E A; Spier, S J; Kortz, G D; Hoffman, E P

1996-08-15

Evaluate histories, clinical signs, and laboratory data of 69 horses homozygous by DNA testing for hyperkalemic periodic paralysis (HPP). Cohort study. 69 of 189 horses testing homozygous for HPP between October 1992 and November 1994. Questionnaires addressing signalment, training regimes, medical history, and current status of affected horses were sent to owners, trainers, or attending veterinarians. Data from completed questionnaires were tabulated and evaluated, using descriptive statistics. Sixty-nine (37%) of 189 questionnaires were completed and returned. Clinical episodes of muscle weakness or paralysis varied in severity and frequency from mild muscle fasciculations to recumbency and death. Sixty-three of 68 HPP-affected horses were reported to have had stridor associated with exercise, excitement, stress, or episodes of muscle paralysis. Common endoscopic findings in affected horses included pharyngeal collapse, pharyngeal edema, laryngopalatal dislocation, and laryngeal paralysis. Twelve of 27 horses receiving acetazolamide had decreases in stridor while receiving medication. Most horses testing homozygous for HPP had clinical signs associated with pharyngeal and laryngeal dysfunction. Hyperkalemic periodic paralysis should be included on a differential list for horses examined for signs of laryngeal or pharyngeal dysfunction or stridor. Treatment with acetazolamide may help to control respiratory tract signs associated with this disease.

Improvement in Self-reported Quality of Life with Cognitive Therapy for Recurrent Major Depressive Disorder

PubMed Central

Jha, Manish Kumar; Minhajuddin, Abu; Thase, Michael E.; Jarrett, Robin B.

2014-01-01

Background Major Depressive Disorder is common, often recurrent and/or chronic. Theoretically, assessing quality of life (QoL) in addition to the current practice of assessing depressive symptoms has the potential to offer a more comprehensive evaluation of the effects of treatment interventions and course of illness. Methods Before and after acute-phase cognitive therapy (CT), 492 patients from Continuation Phase Cognitive Therapy Relapse Prevention trial (Jarrett et al., 2013, Jarrett and Thase, 2010) completed the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Inventory of Depressive Symptomatology Self-report (IDS-SR) & Beck Depression Inventory (BDI); clinicians completed Hamilton Rating Scale for Depression-17-items. Repeated measures analysis of variance evaluated the improvement in QoL before/after CT and measured the effect sizes. Change analyses to assess clinical significance (Hageman and Arrindell, 1999) were conducted. Results At the end of acute-phase CT, a repeated measure analysis of variance produced a statistically significant increase in Q-LES-Q scores with effect sizes of 0.48 - 1.3; 76.9 - 91.4% patients reported clinically significant improvement. Yet, only 11 - 38.2% QoL scores normalized. An analysis of covariance showed that change in depression severity (covariates=IDS-SR, BDI) completely accounted for the improvement in Q-LES-Q scores. Limitations There were only two time points of observation; clinically significant change analyses lacked matched normal controls; and generalizability is constrained by sampling characteristics. Conclusions: Quality of life improves significantly in patients with recurrent MDD after CT; however, this improvement is completely accounted for by change in depression severity. Normalization of QoL in all patients may require targeted, additional, and/or longer treatment. PMID:25082112

Enhancing Pediatric Trainees' and Students' Knowledge in Providing Care to Transgender Youth.

PubMed

Vance, Stanley R; Deutsch, Madeline B; Rosenthal, Stephen M; Buckelew, Sara M

2017-04-01

To enhance pediatric trainees' and students' knowledge of the psychosocial and medical issues facing transgender youth through a comprehensive curriculum. During the 2015-2016 academic year, we administered a transgender youth curriculum to fourth-year medical students, pediatric interns, psychiatry interns, and nurse practitioner students on their 1-month adolescent and young adult medicine rotation. The curriculum included six interactive, online modules and an observational experience in a multidisciplinary pediatric gender clinic. The online modules had a primary care focus with topics of general transgender terminology, taking a gender history, taking a psychosocial history, performing a sensitive physical examination, and formulating an assessment, psychosocial plan, and medical plan. At the completion of the curriculum, learners completed an evaluation that assessed change in perceived awareness and knowledge of transgender-related issues and learner satisfaction with the curriculum. Twenty learners participated in the curriculum with 100% completing the curriculum evaluations, 100% reporting completing all six online modules, and 90% attending the gender clinic. Learners demonstrated a statistically significant improvement in all pre-post knowledge/awareness measures. On a Likert scale where 5 indicated very satisfied, learners' mean rating of the quality of the curriculum was 4.5 ± .7; quality of the modules was 4.4 ± .7; and satisfaction with the observational experience was 4.5 ± .8. A comprehensive curriculum comprised interactive online modules and an observational experience in a pediatric gender clinic was effective at improving pediatric learners' perceived knowledge of the medical and psychosocial issues facing transgender youth. Learners also highly valued the curriculum. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

Improvement in self-reported quality of life with cognitive therapy for recurrent major depressive disorder.

PubMed

Jha, Manish Kumar; Minhajuddin, Abu; Thase, Michael E; Jarrett, Robin B

2014-01-01

Major depressive disorder (MDD) is common, often recurrent and/or chronic. Theoretically, assessing quality of life (QoL) in addition to the current practice of assessing depressive symptoms has the potential to offer a more comprehensive evaluation of the effects of treatment interventions and course of illness. Before and after acute-phase cognitive therapy (CT), 492 patients from Continuation Phase Cognitive Therapy Relapse Prevention trial (Jarrett et al., 2013; Jarrett and Thase, 2010) completed the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q), Inventory of Depressive Symptomatology Self-report (IDS-SR) and Beck Depression Inventory (BDI); clinicians completed Hamilton Rating Scale for Depression-17-items. Repeated measures analysis of variance evaluated the improvement in QoL before/after CT and measured the effect sizes. Change analyses to assess clinical significance (Hageman and Arrindell, 1999) were conducted. At the end of acute-phase CT, a repeated measure analysis of variance produced a statistically significant increase in Q-LES-Q scores with effect sizes of 0.48-1.3%; 76.9-91.4% patients reported clinically significant improvement. Yet, only 11-38.2% QoL scores normalized. An analysis of covariance showed that change in depression severity (covariates=IDS-SR, BDI) completely accounted for the improvement in Q-LES-Q scores. There were only two time points of observation; clinically significant change analyses lacked matched normal controls; and generalizability is constrained by sampling characteristics. Quality of life improves significantly in patients with recurrent MDD after CT; however, this improvement is completely accounted for by change in depression severity. Normalization of QoL in all patients may require targeted, additional, and/or longer treatment. Copyright © 2014 Elsevier B.V. All rights reserved.

[Validity 'and Utilities' clinic of a grid observation (PACSLAC-F) to evaluate the pain in seniors with dementia's living in the Long-Term Care ].

PubMed

Aubin, Michèle; Verreault, René; Savoie, Maryse; LeMay, Sylvie; Hadjistavropoulos, Thomas; Fillion, Lise; Beaulieu, Marie; Viens, Chantal; Bergeron, Rénald; Vézina, Lucie; Misson, Lucie; Fuchs-Lacelle, Shannon

2008-01-01

This study presents the validation of the French Canadian version (PACLSAC-F) of the Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC). Unlike the published validation of the English version of the PACSLAC, which was validated retrospectively, the French version was validated prospectively. The PACSLAC-F was completed by nurses working in long-term care facilities after observing 86 seniors, with severe cognitive impairment, in calm, painful or distressing but non-painful situations. The test-retest and inter-observer reliability, the internal consistency, and the discriminent validity were found to be satisfactory. To evaluate the convergent validity with the DOLOPLUS-2 and the clinical relevance of the PACSLAC, it was also completed by nurses during their work shift, with 26 additional patients, for three days per week during a period of four weeks. These results encourage us to test the PACSLAC in a comprehensive program of pain management targeting this population.

Examining the effect of childhood trauma on psychological distress, risk of violence and engagement, in forensic mental health.

PubMed

Macinnes, Marlene; Macpherson, Gary; Austin, Jessica; Schwannauer, Matthias

2016-12-30

Previous research has found an association between childhood trauma and insecure attachment and psychological distress, risk of violence and engagement in therapy. The aim of this study was to investigate the relationships between these factors in a forensic population. Sixty-four participants from three secure psychiatric hospitals completed the Childhood Trauma Questionnaire (CTQ), the Relationship Scales Questionnaire (RSQ) and the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM). Overall scores from participants' Historical Clinical Risk Management Violence Risk Assessment Scheme, (HCR-20) were calculated. Staff evaluated participants' engagement in therapy via completion of the Service Engagement Scale (SES). This retrospective study found childhood trauma and insecure attachment significantly predicted psychological distress and risk of violence. No associations with engagement were found, but methodological reasons for this outcome were acknowledged. The importance of routinely assessing for a history of childhood trauma and insecure attachment was highlighted. Crown Copyright © 2016. Published by Elsevier Ireland Ltd. All rights reserved.

Treatment of eight dogs with nasal tumours with alternating doses of doxorubicin and carboplatin in conjunction with oral piroxicam.

PubMed

Langova, V; Mutsaers, A J; Phillips, B; Straw, R

2004-11-01

To determine the efficacy and toxicity of chemotherapy in the treatment of canine nasal tumours. Retrospective clinical study Eight dogs with histologically confirmed nasal tumours were staged by means of complete blood count, serum biochemical analysis, cytological analysis of fine needle aspirate of the regional lymph nodes, thoracic radiographs and computed tomography scan of the nasal cavity. All dogs were treated with alternating doses of doxorubicin, carboplatin and oral piroxicam. All dogs were monitored for side effects of chemotherapy and evaluated for response to treatment by computed tomography scan of the nasal cavity after the first four treatments. Complete remission was achieved in four dogs, partial remission occurred in two dogs and two had stable disease on the basis of computed tomography evaluation. There was resolution of clinical signs after one to two doses of chemotherapy in all dogs. This chemotherapy protocol was efficacious and well tolerated in this series of eight cases of canine nasal tumours.

The role of the pediatrician in preventing congenital malformations.

PubMed

Brent, Robert L

2011-10-01

• The development of new knowledge and new diagnostic techniques and technology as well as the sophistication of epidemiology studies and maturation of the fields of clinical genetics and clinical teratology have revolutionized the field of reproductive and developmental biology.• Advances have enabled physicians and scientists to determine the causes of developmental abnormalities and, therefore, discover methods of prevention. The process of evaluation is based on the knowledge base developed over the past 50 years.• Although genetic abnormalities are responsible for a significant proportion of reproductive and developmental deleterious effects, a larger proportion of these effects are due to unknown causes.• Environmental causes are less frequent, although many of the environmental effects as well as many of the genetic effects can be prevented through genetic counseling and preconceptual planning. Effective treatment and amelioration of developmental effects also have improved.• More than 50 environmental drugs, chemicals, maternal diseases, infections, nutritional abnormalities, and physical agents can affect reproduction deleteriously and result in CMs.Theoretically, all these causes are preventable.• Throughout the developing world, the addition of folic acid and iodine could prevent tens of thousands of birth defects and developmental abnormalities.• In the United States, the opportunity for prevention can be introduced at the population level and by addressing individual patients’ clinical problems.• If a mother of a malformed infant had some type of exposure during pregnancy, such as a diagnostic radiologic examination or medication, the consulting physician should not support or suggest the possibility of a causal relationship before performing a complete evaluation. If a pregnant woman who has not yet delivered had some type of exposure during pregnancy, the consulting physician should not support or suggest the possibility that the fetus is at increased risk before performing a complete evaluation. • Every patient deserves a complete, scholarly evaluation that uses the basic principles of teratology and risk analysis.

Outcomes Evaluation of a Weekly Nurse Practitioner-Managed Symptom Management Clinic for Patients With Head and Neck Cancer Treated With Chemoradiotherapy

PubMed Central

Mason, Heidi; DeRubeis, Mary Beth; Foster, Jared C.; Taylor, Jeremy M.G.; Worden, Francis P.

2016-01-01

Purpose/Objectives To determine whether improved monitoring through close follow-up with a nurse practitioner (NP) could enhance treatment compliance and decrease frequency of hospitalizations. Design Retrospective chart review. Setting An academic National Cancer Institute–designated comprehensive cancer center. Sample 151 patients aged 45–65 years diagnosed with stage III or IV oropharyngeal cancer. Methods Patients were nonrandomized to one of two groups: a prechemotherapy clinic group and a weekly NP-led clinic group. After examination of descriptive statistics, multiple linear and logistic regressions were used to compare groups across patient outcomes. Main Research Variables Hospitalization, chemotherapy dose deviations, and chemotherapy treatment completion. Findings The average number of visits during traditional treatment was three and, after initiation of the NP-led clinic, the number was six. The hospitalization rate was 28% in the traditional clinic group compared to 12% in the NP-led group. The rate of chemotherapy dose deviations was 48% in the traditional clinic group compared to 6% in the NP-led clinic group. Forty-six percent of patients in the traditional clinic group received the full seven scheduled doses of chemotherapy compared to 90% of patients seen in the NP-led clinic group. Conclusions A weekly NP-led symptom management clinic reduces rates of hospitalization and chemotherapy dose deviations and increases chemotherapy completion in patients receiving intensive chemoradiotherapy for oropharyngeal cancer. Implications for Nursing Patients receiving chemoradiotherapy benefit from close monitoring for toxicities by NPs to successfully complete their treatment and avoid hospitalization. Knowledge Translation Early interventions to manage toxicities in patients with head and neck cancer can improve outcomes. NPs are in a key position to manage these toxicities and, when symptoms are controlled, costs are reduced. PMID:24007925

Clinical evaluation of fiber-reinforced epoxy resin posts and cast post and cores.

PubMed

Ferrari, M; Vichi, A; García-Godoy, F

2000-05-01

This retrospective study evaluated treatment outcome of cast post and core and Composipost systems after 4 yrs of clinical service. 200 patients were included in the study. They were divided in two groups of 100 endodontically treated teeth restored with a post. Group 1: Composipost systems were luted into root canal following the manufacturer's instructions. Group 2: Cast post and cores were cemented into root canal preparations with a traditional technique. The patients were recalled after 6 months, 1, 2 and 4 yrs and clinical and radiographic examinations were completed. Endodontic and prosthodontic results were recorded. Group 1: 95% of the teeth restored with Composiposts showed clinical success; 3% of these samples were excluded for noncompliance and 2% showed endodontic failure. Group 2: Clinical success was found with 84% of teeth restored with cast post and core. 2% of these samples were excluded for noncompliance, 9% showed root fracture, 2% dislodgment of crown and 3% endodontic failure. Statistical evaluation showed significant differences between Groups 1 and 2 (P < 0.001). The results of this retrospective study indicated that the Composipost system was superior to the conventional cast post and core system after 4 yrs of clinical service.

Content and Evaluation of the Benefits of Effective Exercise for Older Adults With Knee Pain Trial Physiotherapist Training Program.

PubMed

Holden, Melanie A; Whittle, Rebecca; Healey, Emma L; Hill, Susan; Mullis, Ricky; Roddy, Edward; Sowden, Gail; Tooth, Stephanie; Foster, Nadine E

2017-05-01

To explore whether participating in the Benefits of Effective Exercise for knee Pain (BEEP) trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain in older adults. Before/after training program evaluation. Physiotherapists were asked to complete a questionnaire before the BEEP trial training program, immediately after, and 12 to 18 months later (postintervention delivery in the BEEP trial). The questionnaire included a case vignette and associated clinical management questions. Questionnaire responses were compared over time and between physiotherapists trained to deliver each intervention within the BEEP trial. Primary care. Physiotherapists (N=53) who completed the BEEP trial training program. Not applicable. Self-confidence in the diagnosis and management of knee pain in older adults; and intended clinical behavior measured by a case vignette and associated clinical management questions. Fifty-two physiotherapists (98%) returned the pretraining questionnaire, and 44 (85%) and 39 (74%) returned the posttraining and postintervention questionnaires, respectively. Posttraining, self-confidence in managing older adults with knee pain increased, and intended clinical behavior regarding exercise for knee pain in older adults appeared more in line with clinical guidelines. However, not all positive changes were maintained in the longer-term. Participating in the BEEP trial training program increased physiotherapists' self-confidence and changed their intended clinical behavior regarding exercise for knee pain, but by 12 to 18 months later, some of these positive changes were lost. This suggests that brief training programs are useful, but additional strategies are likely needed to successfully maintain changes in clinical behavior over time. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial.

PubMed

Jabbour, Mona; Curran, Janet; Scott, Shannon D; Guttman, Astrid; Rotter, Thomas; Ducharme, Francine M; Lougheed, M Diane; McNaughton-Filion, M Louise; Newton, Amanda; Shafir, Mark; Paprica, Alison; Klassen, Terry; Taljaard, Monica; Grimshaw, Jeremy; Johnson, David W

2013-05-22

The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for 'point of care' management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma--the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis--the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. ClinicalTrials.gov: NCT01815710.

Postoperative Swallowing Assessment After Lung Transplantation.

PubMed

Baumann, Brooke; Byers, Sara; Wasserman-Wincko, Tamara; Smith, Libby; Hathaway, Bridget; Bhama, Jay; Shigemura, Norihisa; Hayanga, J W Awori; D'Cunha, Jonathan; Johnson, Jonas T

2017-07-01

Dysphagia, aspiration, and potential pneumonia represent a major source of morbidity in patients undergoing lung transplantation. Conditions that potentiate dysphagia and aspiration include frailty and prolonged intubation. Our group of speech-language pathologists has been actively involved in performance of a bedside evaluation of swallowing, and instrumental evaluation of swallowing with modified barium swallow, and postoperative management in patients undergoing lung transplantation. All lung transplant patients from April 2009 to September 2012 were evaluated retrospectively. A clinical bedside examination was performed by the speech-language pathology team, followed by a modified barium swallow or fiberoptic endoscopic evaluation of swallowing. A total of 321 patients were referred for evaluation. Twenty-four patients were unable to complete the evaluation. Clinical signs of aspiration were apparent in 160 patients (54%). Deep laryngeal penetration or aspiration were identified in 198 (67%) patients during instrumental testing. A group of 81 patients (27%) had an entirely normal clinical examination, but were found to have either deep penetration or aspiration. The majority of patients aspirate after lung transplantation. Clinical bedside examination is not sensitive enough and will fail to identify patients with silent aspiration. A standard of practice following lung transplantation has been established that helps avoid postoperative aspiration associated with complications. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

An open, self-controlled study on the efficacy of topical indoxacarb for eliminating fleas and clinical signs of flea-allergy dermatitis in client-owned dogs in Queensland, Australia.

PubMed

Fisara, Petr; Sargent, Roger M; Shipstone, Michael; von Berky, Andrew; von Berky, Janet

2014-06-01

Canine flea-allergy dermatitis (FAD), a hypersensitivity response to antigenic material in the saliva of feeding fleas, occurs worldwide and remains a common presentation in companion animal veterinary practice despite widespread availability of effective systemic and topical flea-control products. To evaluate the clinical response in dogs with FAD treated topically with indoxacarb, a novel oxadiazine insecticide. Twenty-five client-owned dogs in Queensland, Australia diagnosed with pre-existing FAD on the basis of clinical signs, flea-antigen intradermal and serological tests. An open-label, noncontrolled study, in which all dogs were treated with topical indoxacarb at 4 week intervals, three times over 12 weeks. Twenty-four dogs completed the study. Complete resolution of clinical signs of FAD was observed in 21 cases (87.5%), with nearly complete resolution or marked improvement in the remaining three cases. Mean clinical scores (Canine Atopic Dermatitis Extent and Severity Index-03) were reduced by 93.3% at week 12. Mean owner-assessed pruritus scores were reduced by 88% by week 12. Mean flea counts reduced by 98.7 and 100% in weeks 8 and 12, respectively. Topical indoxacarb treatment applied every 4 weeks for 12 weeks, without concomitant antipruritic or ectoparasiticide therapy, completely alleviated flea infestations in all dogs and associated clinical signs of FAD in a high proportion of this population of dogs in a challenging flea-infestation environment. © 2014 The Authors. Veterinary Dermatology published by John Wiley & Sons Ltd on behalf of the ESVD and the ACVD.

Personalized contact strategies and predictors of time to survey completion: analysis of two sequential randomized trials.

PubMed

Dinglas, Victor D; Huang, Minxuan; Sepulveda, Kristin A; Pinedo, Mariela; Hopkins, Ramona O; Colantuoni, Elizabeth; Needham, Dale M

2015-01-09

Effective strategies for contacting and recruiting study participants are critical in conducting clinical research. In this study, we conducted two sequential randomized controlled trials of mail- and telephone-based strategies for contacting and recruiting participants, and evaluated participant-related variables' association with time to survey completion and survey completion rates. Subjects eligible for this study were survivors of acute lung injury who had been previously enrolled in a 12-month observational follow-up study evaluating their physical, cognitive and mental health outcomes, with their last study visit completed at a median of 34 months previously. Eligible subjects were contacted to complete a new research survey as part of two randomized trials, initially using a randomized mail-based contact strategy, followed by a randomized telephone-based contact strategy for non-responders to the mail strategy. Both strategies focused on using either a personalized versus a generic approach. In addition, 18 potentially relevant subject-related variables (e.g., demographics, last known physical and mental health status) were evaluated for association with time to survey completion. Of 308 eligible subjects, 67% completed the survey with a median (IQR) of 3 (2, 5) contact attempts required. There was no significant difference in the time to survey completion for either randomized trial of mail- or phone-based contact strategy. Among all subject-related variables, age ≤40 years and minority race were independently associated with a longer time to survey completion. We found that age ≤40 years and minority race were associated with a longer time to survey completion, but personalized versus generic approaches to mail- and telephone-based contact strategies had no significant effect. Repeating both mail and telephone contact attempts was important for increasing survey completion rate. NCT00719446.

Enhanced skills in periodontology: evaluation of a pilot scheme for general dental practitioners and dental care professionals in London.

PubMed

Ghotane, S G; Harrison, V; Radcliffe, E; Jones, E; Gallagher, J E

2017-05-12

Background The need for periodontal management is great and increasing; thus, the oral and dental workforce should be suitably equipped to deliver contemporary care. Health Education London developed a training scheme to extend the skills of dentists and dental care professionals (DCPs).Aim To examine the feasibility of assessing a skill-mix initiative established to enhance skills in clinical periodontology involving the views of patients, clinicians and key stakeholders, together with clinical and patient outcomes in London.Methods This mixed methods feasibility and pilot study involved four parallel elements: a postal questionnaire survey of patients; analysis of clinical logbooks; self-completion questionnaire survey of clinicians; and semi-structured interviews of key stakeholders, including clinicians.Results Twelve of the 19 clinicians participated in the evaluation, returning completed questionnaires (63%) and providing access to log diaries and patients. Periodontal data from 42 log-diary cases (1,103 teeth) revealed significant improvement in clinical outcomes (P = 0.001 for all). Eighty-four percent (N = 99) of the 142 patients returning a questionnaire reported improved dental health; however, responses from hospital patients greatly exceeded those from dental practice. Interviews (N = 22) provided evidence that the programme contributed to professional healthcare across four key domains: 'service', 'quality care', 'professional' and 'educational'. Clinicians, while supportive of the concept, raised concerns regarding the mismatch of their expectations and its educational and service outcomes.Discussion The findings suggest that it is feasible to deliver and evaluate inter-professional extended skills training for dentists and dental care professionals, and this may be evaluated using mixed methods to examine outcomes including clinical log diaries, patient questionnaires and stakeholder interviews. This inter-professional course represents a positive development for patient care using the expertise of different members of the dental team; however, its formal integration to the health and educational sectors require further consideration.

Accelerated Training of Skilled Birth Attendants in a Marginalized Population on the Thai-Myanmar Border: A Multiple Methods Program Evaluation.

PubMed

White, Adrienne Lynne; Min, Thaw Htwe; Gross, Mechthild M; Kajeechiwa, Ladda; Thwin, May Myo; Hanboonkunupakarn, Borimas; Than, Hla Hla; Zin, Thet Wai; Rijken, Marcus J; Hoogenboom, Gabie; McGready, Rose

2016-01-01

To evaluate a skilled birth attendant (SBA) training program in a neglected population on the Thai-Myanmar border, we used multiple methods to show that refugee and migrant health workers can be given effective training in their own environment to become SBAs and teachers of SBAs. The loss of SBAs through resettlement to third countries necessitated urgent training of available workers to meet local needs. All results were obtained from student records of theory grades and clinical log books. Qualitative evaluation of both the SBA and teacher programs was obtained using semi-structured interviews with supervisors and teachers. We also reviewed perinatal indicators over an eight-year period, starting prior to the first training program until after the graduation of the fourth cohort of SBAs. Four SBA training programs scheduled between 2009 and 2015 resulted in 79/88 (90%) of students successfully completing a training program of 250 theory hours and 625 supervised clinical hours. All 79 students were able to: achieve pass grades on theory examination (median 80%, range [70-89]); obtain the required clinical experience within twelve months; achieve clinical competence to provide safe care during childbirth. In 2010-2011, five experienced SBAs completed a train-the-trainer (TOT) program and went on to facilitate further training programs. Perinatal indicators within Shoklo Malaria Research Unit (SMRU), such as place of birth, maternal and newborn outcomes, showed no significant differences before and after introduction of training or following graduate deployment in the local maternity units. Confidence, competence and teamwork emerged from qualitative evaluation by senior SBAs working with and supervising students in the clinics. We demonstrate that in resource-limited settings or in marginalized populations, it is possible to accelerate training of skilled birth attendants to provide safe maternity care. Education needs to be tailored to local needs to ensure evidence-based care of women and their families.

Accelerated Training of Skilled Birth Attendants in a Marginalized Population on the Thai-Myanmar Border: A Multiple Methods Program Evaluation

PubMed Central

White, Adrienne Lynne; Min, Thaw Htwe; Gross, Mechthild M.; Kajeechiwa, Ladda; Thwin, May Myo; Hanboonkunupakarn, Borimas; Than, Hla Hla; Zin, Thet Wai; Rijken, Marcus J.; Hoogenboom, Gabie; McGready, Rose

2016-01-01

Background To evaluate a skilled birth attendant (SBA) training program in a neglected population on the Thai-Myanmar border, we used multiple methods to show that refugee and migrant health workers can be given effective training in their own environment to become SBAs and teachers of SBAs. The loss of SBAs through resettlement to third countries necessitated urgent training of available workers to meet local needs. Methods and Findings All results were obtained from student records of theory grades and clinical log books. Qualitative evaluation of both the SBA and teacher programs was obtained using semi-structured interviews with supervisors and teachers. We also reviewed perinatal indicators over an eight-year period, starting prior to the first training program until after the graduation of the fourth cohort of SBAs. Results Four SBA training programs scheduled between 2009 and 2015 resulted in 79/88 (90%) of students successfully completing a training program of 250 theory hours and 625 supervised clinical hours. All 79 students were able to: achieve pass grades on theory examination (median 80%, range [70–89]); obtain the required clinical experience within twelve months; achieve clinical competence to provide safe care during childbirth. In 2010–2011, five experienced SBAs completed a train-the-trainer (TOT) program and went on to facilitate further training programs. Perinatal indicators within Shoklo Malaria Research Unit (SMRU), such as place of birth, maternal and newborn outcomes, showed no significant differences before and after introduction of training or following graduate deployment in the local maternity units. Confidence, competence and teamwork emerged from qualitative evaluation by senior SBAs working with and supervising students in the clinics. Conclusions We demonstrate that in resource-limited settings or in marginalized populations, it is possible to accelerate training of skilled birth attendants to provide safe maternity care. Education needs to be tailored to local needs to ensure evidence-based care of women and their families. PMID:27711144

Treatment of multiple adjacent Miller Class I and II gingival recessions with collagen matrix and the modified coronally advanced tunnel technique.

PubMed

Molnár, Bálint; Aroca, Sofia; Keglevich, Tibor; Gera, István; Windisch, Péter; Stavropoulos, Andreas; Sculean, Anton

2013-01-01

To clinically evaluate the treatment of Miller Class I and II multiple adjacent gingival recessions using the modified coronally advanced tunnel technique combined with a newly developed bioresorbable collagen matrix of porcine origin. Eight healthy patients exhibiting at least three multiple Miller Class I and II multiple adjacent gingival recessions (a total of 42 recessions) were consecutively treated by means of the modified coronally advanced tunnel technique and collagen matrix. The following clinical parameters were assessed at baseline and 12 months postoperatively: full mouth plaque score (FMPS), full mouth bleeding score (FMBS), probing depth (PD), recession depth (RD), recession width (RW), keratinized tissue thickness (KTT), and keratinized tissue width (KTW). The primary outcome variable was complete root coverage. Neither allergic reactions nor soft tissue irritations or matrix exfoliations occurred. Postoperative pain and discomfort were reported to be low, and patient acceptance was generally high. At 12 months, complete root coverage was obtained in 2 out of the 8 patients and 30 of the 42 recessions (71%). Within their limits, the present results indicate that treatment of Miller Class I and II multiple adjacent gingival recessions by means of the modified coronally advanced tunnel technique and collagen matrix may result in statistically and clinically significant complete root coverage. Further studies are warranted to evaluate the performance of collagen matrix compared with connective tissue grafts and other soft tissue grafts.

Improving transparency and reproducibility through registration: The status of intervention trials published in clinical psychology journals.

PubMed

Cybulski, Lukasz; Mayo-Wilson, Evan; Grant, Sean

2016-09-01

Prospective registration increases the validity of randomized controlled trials (RCTs). In the United States, registration is a legal requirement for drugs and devices regulated by the Food and Drug Administration (FDA), and many biomedical journals refuse to publish trials that are not registered. Trials in clinical psychology have not been subject to these requirements; it is unknown to what extent they are registered. We searched the 25 highest-impact clinical psychology journals that published at least 1 RCT of a health-related psychological intervention in 2013. For included trials, we evaluated their registration status (prospective, retrospective, not registered) and the completeness of their outcome definitions. We identified 163 articles that reported 165 RCTs; 73 (44%) RCTs were registered, of which only 25 (15%) were registered prospectively. Of registered RCTs, only 42 (58%) indicated their registration status in the publication. Only 2 (1% of all trials) were registered prospectively and defined their primary outcomes completely. For the primary outcome(s), 72 (99%) of all registrations defined the domain, 67 (92%) the time frame, and 48 (66%) the specific measurements. Only 19 (26%) and 5 (7%) defined the specific metric and method of aggregation, respectively, for all primary outcomes. Very few reports of RCTs published in clinical psychology journals were registered prospectively and completely. Clinical psychology journals could improve transparency and reproducibility, as well as reduce bias, by requiring complete prospective trial registration for publication and by including trial registration numbers in all reports of RCTs. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

Clinical Amyloid Imaging.

PubMed

Mallik, Atul; Drzezga, Alex; Minoshima, Satoshi

2017-01-01

Amyloid plaques, along with neurofibrillary tangles, are a neuropathologic hallmark of Alzheimer disease (AD). Recently, amyloid PET radiotracers have been developed and approved for clinical use in the evaluation of suspected neurodegenerative disorders. In both research and clinical settings, amyloid PET imaging has provided important diagnostic and prognostic information for the management of patients with possible AD, mild cognitive impairment (MCI), and other challenging diagnostic presentations. Although the overall impact of amyloid imaging is still being evaluated, the Society of Nuclear Medicine and Molecular Imaging and Alzheimer's Association Amyloid Imaging Task Force have created appropriate use criteria for the standard clinical use of amyloid PET imaging. By the appropriate use criteria, amyloid imaging is appropriate for patients with (1) persistent or unexplained MCI, (2) AD as a possible but still uncertain diagnosis after expert evaluation and (3) atypically early-age-onset progressive dementia. To better understand the clinical and economic effect of amyloid imaging, the Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) study is an ongoing large multicenter study in the United States, which is evaluating how amyloid imaging affects diagnosis, management, and outcomes for cognitively impaired patients who cannot be completely evaluated by clinical assessment alone. Multiple other large-scale studies are evaluating the prognostic role of amyloid PET imaging for predicting MCI progression to AD in general and high-risk populations. At the same time, amyloid imaging is an important tool for evaluating potential disease-modifying therapies for AD. Overall, the increased use of amyloid PET imaging has led to a better understanding of the strengths and limitations of this imaging modality and how it may best be used with other clinical, molecular, and imaging assessment techniques for the diagnosis and management of neurodegenerative disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

Bringing interdisciplinary and multicultural team building to health care education: the downstate team-building initiative.

PubMed

Hope, Joanie Mayer; Lugassy, Daniel; Meyer, Rina; Jeanty, Freida; Myers, Stephanie; Jones, Sadie; Bradley, Joann; Mitchell, Rena; Cramer, Eva

2005-01-01

To evaluate the impact of the Downstate Team-Building Initiative (DTBI), a model multicultural and interdisciplinary health care team-building program for health professions students. A total of 65 students representing seven health disciplines participated in DTBI's first three years (one cohort per year since implementation). During the 18-session curriculum, students self-evaluated their group's progress through Tuckman's four team-development stages (FORMING, STORMING, NORMING, PERFORMING) on an 11-point scale. Students completed matched pre- and postintervention program evaluations assessing five variables: interdisciplinary understanding, interdisciplinary attitudes, teamwork skills, multicultural skills, and team atmosphere. After participation, students completed narrative follow-up questionnaires investigating impact one and two years after program completion. Each year's team development curve followed a similar logarithmic trajectory. Cohort 1 remained in team development stage 3 (NORMING) while Cohorts 2 and 3 advanced into the final stage-PERFORMING. A total of 34 matched pre- and postintervention evaluations showed significant change in all major variables: Team atmosphere and group teamwork skills improved most (48% and 44%, respectively). Interdisciplinary understanding improved 42%. Individual multicultural skills (defined by ability to address racism, homophobia, and sexism) started at the highest baseline and improved the least (13%). Group multicultural skills improved 36%. Of 23 responses to the follow-up surveys, 22 (96%) stated DTBI was a meaningful educational experience applicable to their current clinical surroundings. DTBI successfully united students across health discipline, ethnicity, socioeconomic class, gender, and sexual orientation into functioning teams. The model represents an effective approach to teaching health care team building and demonstrates benefits in both preclinical and clinical years of training.

Randomised, placebo-controlled, double-blind, split-face study on the clinical efficacy of Tricutan on skin firmness.

PubMed

Sommerfeld, B

2007-11-01

Tricutan is a combination product of herbal extracts traditionally used for treatment of skin conditions, together with dimethylaminoethanol. The effectiveness of Tricutan in improving skin firmness and elasticity in photoaged facial skin was examined in a randomised, placebo-controlled, double-blind, split-face study in 28 women, 34-67 years old. Treatment with Tricutan and placebo was given for 4 weeks. Skin firmness and elasticity was evaluated using the speed of propagation of ultrasound shear waves in the skin as end point (Reviscometer RVM 600). The study was completed by 25 women. The Tricutan treatment resulted in a significantly reduced propagation speed indicating increased firmness. There was no immediate effect by Tricutan application on propagation speed. At self evaluation the women evaluated the treatment effect of Tricutan to be significantly better than the treatment effect of placebo. The clinical evaluation also showed Tricutan to give a significantly better treatment result than placebo. Tolerance to Tricutan was generally good. However, three women did not complete the study because of mild irritative contact dermatitis. The results show that Tricutan can increase skin firmness both objectively and subjectively. Further studies are warranted, especially to investigate if Tricutan can delay the need for surgical face-lift procedures.

A virtual patient software program to improve pharmacy student learning in a comprehensive disease management course.

PubMed

Douglass, Mark A; Casale, Jillian P; Skirvin, J Andrew; DiVall, Margarita V

2013-10-14

To implement and assess the impact of a virtual patient pilot program on pharmacy students' clinical competence skills. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students' posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes.

Increasing Colonoscopy Screening in Disparate Populations: Results From an Evaluation of Patient Navigation in the New Hampshire Colorectal Cancer Screening Program

PubMed Central

Rice, Ketra; Gressard, Lindsay; DeGroff, Amy; Gersten, Joanne; Robie, Janene; Leadbetter, Steven; Glover-Kudon, Rebecca; Butterly, Lynn

2018-01-01

BACKGROUND To investigate uniformly successful results from a statewide program of patient navigation (PN) for colonoscopy, this comparison study evaluated the effectiveness of the PN intervention by comparing outcomes for navigated versus non-navigated patients in one of the community health clinics included in the statewide program. Outcomes measured included screening completion, adequacy of bowel preparation, missed appointments and cancellations, communication of test results, and consistency of follow-up recommendations with clinical guidelines. METHODS The authors compared a subset of 131 patients who were navigated to a screening or surveillance colonoscopy with a similar subset of 75 non-navigated patients at one endoscopy clinic. The prevalence and prevalence odds ratios were computed to measure the association between PN and each study outcome measure. RESULTS Patients in the PN intervention group were 11.2 times more likely to complete colonoscopy than control patients (96.2% vs 69.3%; P<.001), and were 5.9 times more likely to have adequate bowel preparation (P =.010). In addition, intervention patients had no missed appointments compared with 15.6% of control patients, and were 24.8 times more likely to not have a cancellation <24 hours before their appointment (P<.001). All navigated patients and their primary care providers received test results, and all follow-up recommendations were consistent with clinical guidelines compared with 82.4% of patients in the control group (P<.001). CONCLUSIONS PN appears to be effective for improving colonoscopy screening completion and quality in the disparate populations most in need of intervention. To the best of our knowledge, the results of the current study demonstrate some of the strongest evidence for the effectiveness of PN to date, and highlight its value for public health. PMID:28464213

Improving HCV cure rates in HIV-coinfected patients - a real-world perspective.

PubMed

Lakshmi, Seetha; Alcaide, Maria; Palacio, Ana M; Shaikhomer, Mohammed; Alexander, Abigail L; Gill-Wiehl, Genevieve; Pandey, Aman; Patel, Kunal; Jayaweera, Dushyantha; Del Pilar Hernandez, Maria

2016-05-01

To study rates and predictors of hepatitis C virus (HCV) cure among human immunodeficiency virus (HIV)/HCV-coinfected patients, and then to evaluate the effect of attendance at clinic visits on HCV cure. Retrospective cohort study of adult HIV/HCV-coinfected patients who initiated and completed treatment for HCV with direct-acting antivirals (DAAs) between January 1, 2014, and June 30, 2015. Eighty-four participants reported completing treatment. The median age was 58 years (interquartile ratio, 50-66); 88% were male and 50% were black. One-third were cirrhotic and half were HCV-treatment-experienced. The most commonly used regimen was sofosbuvir/ledipasvir (40%) followed by simeprevir/sofosbuvir (30%). Cure was achieved in 83.3%, 11.9% relapsed, and 2.3% experienced virological breakthrough. Two patients (2.3%) did not complete treatment based on pill counts and follow-up visit documentation. In multivariable analysis, cure was associated with attendance at follow-up clinic visits (odds ratio [OR], 9.0; 95% CI, 2.91-163) and with use of an integrase-based HIV regimen versus other non-integrase regimens, such as non-nucleoside analogues or protease inhibitors (OR, 6.22; 95% CI 1.81-141). Age, race, genotype, presence of cirrhosis, prior HCV treatment, HCV regimen, and pre-treatment CD4 counts were not associated with cure. Real-world HCV cure rates with DAAs in HCV/HIV coinfection are lower than those seen in clinical trials. Cure is associated with attendance at follow-up clinic visits and with use of an integrase-based HIV regimen. Future studies should evaluate best antiretroviral regimens, predictors of attendance at follow-up visits, impact of different monitoring protocols on medication adherence, and interventions to ensure adequate models of HIV/HCV care.

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

PubMed

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

2017-01-01

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

Impact of the CONSORT Statement endorsement in the completeness of reporting of randomized clinical trials in restorative dentistry.

PubMed

Sarkis-Onofre, Rafael; Poletto-Neto, Victório; Cenci, Maximiliano Sérgio; Pereira-Cenci, Tatiana; Moher, David

2017-03-01

The aim of this study was to assess if journal endorsement of the CONSORT Statement is associated with improved completeness of reporting of randomized controlled trials (RCTs) in restorative dentistry. RCTs in restorative dentistry published in two journals that have (Journal of Dentistry and Clinical Oral Investigations) and have not (Operative Dentistry and Journal of Prosthetic Dentistry) endorsed the CONSORT Statement were selected. We compared the completeness of reporting between comparison groups (endorsers versus non-endorsers, before versus after endorsement) using a risk ratio (RR) with a 99% confidence interval for each outcome of CONSORT 2010. Also, the risk of bias of each study was evaluated. The electronic search retrieved a total of 3701 records. After the title and abstract evaluation, 169 full texts were screened and 79 RCTs identified. Considering CONSORT-endorsing journals before and after CONSORT endorsement, six items had effect estimates indicating a relatively higher proportion of completely reported RCTs published after CONSORT endorsement. Considering CONSORT-endorsing journals compared to non-endorsing journals, twelve items indicated a relatively higher proportion of completely reported RCTs published in CONSORT-endorsing journals. In both analyses the overall evidence did not present statistical significance. Although CONSORT endorsement has been linked with some improvement in the completeness of RCTs reports in the biomedical literature, this was not reflected in the present analysis confined to restorative dentistry. More innovative and involved approaches to enhancing reported may therefore be required. Inadequate reporting of randomized controlled trials can produce important consequences for all stakeholders including waste of resources and implication on healthcare decisions. A broad understandment of the use of reporting guidelines is necessary to lead to better results. Copyright © 2017 Elsevier Ltd. All rights reserved.

Student Evaluation of Faculty Physicians: Gender Differences in Teaching Evaluations.

PubMed

Morgan, Helen K; Purkiss, Joel A; Porter, Annie C; Lypson, Monica L; Santen, Sally A; Christner, Jennifer G; Grum, Cyril M; Hammoud, Maya M

2016-05-01

To investigate whether there is a difference in medical student teaching evaluations for male and female clinical physician faculty. The authors examined all teaching evaluations completed by clinical students at one North American medical school in the surgery, obstetrics and gynecology, pediatrics, and internal medicine clinical rotations from 2008 to 2012. The authors focused on how students rated physician faculty on their "overall quality of teaching" using a 5-point response scale (1 = Poor to 5 = Excellent). Linear mixed-effects models provided estimated mean differences in evaluation outcomes by faculty gender. There were 14,107 teaching evaluations of 965 physician faculty. Of these evaluations, 7688 (54%) were for male physician faculty and 6419 (46%) were for female physician faculty. Female physicians received significantly lower mean evaluation scores in all four rotations. The discrepancy was largest in the surgery rotation (males = 4.23, females = 4.01, p = 0.003). Pediatrics showed the next greatest difference (males = 4.44, females = 4.29, p = 0.009), followed by obstetrics and gynecology (males = 4.38, females = 4.26, p = 0.026), and internal medicine (males = 4.35, females = 4.27, p = 0.043). Female physicians received lower teaching evaluations in all four core clinical rotations. This comprehensive examination adds to the medical literature by illuminating subtle differences in evaluations based on physician gender, and provides further evidence of disparities for women in academic medicine.

Developing an advanced practice nurse-led liver clinic.

PubMed

McAfee, Jean L

2012-01-01

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

Nurse-led management of chronic disease in a residential care setting.

PubMed

Neylon, Julie

2015-11-01

Introduction of the advanced nurse practitioner (ANP) role has enabled nurses to develop their clinical knowledge and skills, providing greater service provision and improved access to healthcare services. It can also help with the challenges of providing care to an ageing population in primary care. This article reports on the evaluation of an ANP-led clinic in two residential care homes that provides annual reviews for chronic disease management (CDM). A mixed method approach was used to evaluate the service using clinical data obtained from the electronic patient record system and software and patient satisfaction questionnaires. The number of patients receiving CDM reviews in the homes increased as a result of the clinic. Completed satisfaction questionnaires further demonstrated patients' satisfaction and willingness to engage with the service. The service highlights the ANP's effectiveness in managing residential care home patients with chronic diseases and improving their access to healthcare services.

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

PubMed

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

2010-12-01

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

Clinical experience with the radioisotope varicocele scan as a screening method for the detection of subclinical varicoceles

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

Wheatley, J.K.; Fajman, W.A.; Witten, F.R.

1982-07-01

The association of varicoceles and subfertility has been well documented. Although varicoceles remain the most common surgically correctable cause of male infertility the diagnosis of small varicoceles remains a challenge. We evaluated 40 men with an isotope blood pooling scan. Seven volunteers served as either positive or negative controls. Complete correlation between physical findings and the isotope scan was found. The 6 patients with obvious clinical varicoceles and a stress pattern on semen analysis all had positive scans. The 18 patients with a stress pattern and who were clinically suspected of having a varicocele all had positive scans. Of 9more » patients evaluated for infertility with a stress pattern but no clinical evidence of varicocele 6 had positive scans. We believe that the isotope scan will prove to be a useful procedure in the detection of nonpalpable varicoceles in selected subfertile men.« less

Contrast-enhanced spectral mammography (CESM) versus MRI in the high-risk screening setting: patient preferences and attitudes.

PubMed

Phillips, Jordana; Miller, Matthew M; Mehta, Tejas S; Fein-Zachary, Valerie; Nathanson, Audrey; Hori, Wendy; Monahan-Earley, Rita; Slanetz, Priscilla J

Our study evaluates patient preferences toward screening CESM versus MRI. As part of a prospective study, high-risk patients had breast MRI and CESM. Patients completed an anonymous survey to evaluate preferences regarding the two modalities. 88% of participants completed the survey. 79% preferred CESM over MRI if the exams had equal sensitivity. 89% would be comfortable receiving contrast as part of an annual screening test. High-risk populations may accept CESM as a screening exam and may prefer it over screening MRI if ongoing trials demonstrate screening CESM to be clinically non-inferior MRI. Copyright © 2016 Elsevier Inc. All rights reserved.

Managing multicentre clinical trials with open source.

PubMed

Raptis, Dimitri Aristotle; Mettler, Tobias; Fischer, Michael Alexander; Patak, Michael; Lesurtel, Mickael; Eshmuminov, Dilmurodjon; de Rougemont, Olivier; Graf, Rolf; Clavien, Pierre-Alain; Breitenstein, Stefan

2014-03-01

Multicentre clinical trials are challenged by high administrative burden, data management pitfalls and costs. This leads to a reduced enthusiasm and commitment of the physicians involved and thus to a reluctance in conducting multicentre clinical trials. The purpose of this study was to develop a web-based open source platform to support a multi-centre clinical trial. We developed on Drupal, an open source software distributed under the terms of the General Public License, a web-based, multi-centre clinical trial management system with the design science research approach. This system was evaluated by user-testing and well supported several completed and on-going clinical trials and is available for free download. Open source clinical trial management systems are capable in supporting multi-centre clinical trials by enhancing efficiency, quality of data management and collaboration.

Using low-cost Android tablets and instructional videos to teach clinical skills to medical students in Kenya: a prospective study.

PubMed

O'Donovan, James; Ahn, Roy; Nelson, Brett D; Kagan, Calvin; Burke, Thomas F

2016-08-01

To assess the feasibility and impact of using a low-cost Android tablet to deliver clinical skills training to third-year medical students in Kenya. A prospective study using a low cost tablet called 'connecTAB', which was designed and manufactured specifically for areas with low bandwidth. Instructional video tutorials demonstrating techniques of cardiovascular and abdominal clinical examinations were pre-loaded onto the tablet. Maseno University School of Medicine, Western Kenya. Fifty-one third-year medical students from Maseno University School of Medicine were subjects in the study. Twenty-five students were assigned to the intervention group and 26 to the control group. At the start of the study, students from both groups completed an Observed Structured Clinical Examination (OSCE) of the cardiovascular and abdominal evaluations. Students who were allocated to the intervention group then received the connecTAB, whereas students in the control group did not. After a period of three weeks, students from both groups completed a post-study OSCE for both the cardiovascular and abdominal evaluations. There were significantly higher improvements in the scores for both cardiovascular and abdominal examinations (p < 0.001) within the group who received the e-tablets as compared to the control group. The study suggests that access to connecTAB improves clinical education and efficacy and holds promise for international training in both medical and allied healthcare professional spheres in resource-limited settings.

PACS in the Utrecht University Hospital: final conclusions of the clinical evaluation

NASA Astrophysics Data System (ADS)

Wilmink, J. B.; ter Haar Romeny, Bart M.; Barneveld Binkhuysen, Frits H.; Achterberg, A. J.; Zuiderveld, Karel J.; Calkoen, P.; Kouwenberg, Jef M.

1990-08-01

In the past three years, a clinical evaluation of a PACS has been performed in the Utrecht University Hospital as part of the Dutch PACS project. The clinical evaluation focussed on the following aspects: technical evaluation of the prototype PACS equipment coupled to the HIS; diagnostic accuracy studies; studies concerning the impact on the organization of the radiology-department and the referring wards; and cost-savings analysis. Some of the results of these subprojects have already been presented at previous SPIE conferences. In this paper the general condusions are presented about the usefulness of the evaluated PAC-System in the daily routine of radiology department and clinic. By making available the images of radiological examinations fast, complete, reliable and continously on the ward, concrete improvements with regard to the current process could be realized. The possibilities of PACS caused an increasing enthousiasm among the clinicians. By the easier access to all images of their patients during 24 hours/day, they saw more images on the day of the examination and images could be more easily used at consultations of other specialists. The overall conclusion is positive, but a lot of work has to be done to transform PACS from an experimental setup into a routine production system on which a flimless hospital can be based. A complete PACS needs an inteffigent Image Management System, which indudes prefetching algorithms based on data from the Hospital Information System and automated procedures for removing obsolete images from the local buffers in the workstations. As yet PACS is very expensive, and the direct savings in the hospital cannot compensate for the high costs of investment. Possibly PACS can contribute to a shorter stay of patients in the hospital. This will lead to savings for government and health insurance companies and they can be expected to contribute to PAS implementation studies.

Development of a self-reporting tool to obtain a combined index of severity of fibromyalgia (ICAF).

PubMed

Vallejo, Miguel A; Rivera, Javier; Esteve-Vives, Joaquim

2010-01-07

Fibromyalgia is a syndrome with heterogeneous symptoms. The evaluation in the clinical setting usually fails to cover the complexity of the syndrome. This study aims to determine how different aspects of fibromyalgia are inter-related when measured by means of a self-reporting tool. The objective is to develop a more complete evaluation model adjusted to the complexity and multi-dimensional nature of the syndrome. Application was made of the Fibromyalgia Impact Questionnaire, the Hospital Anxiety and Depression Scale, the Brief Pain Inventory, the Fatigue Assessment Scale, the Health Assessment Questionnaire, the General Health Questionnaire (GHQ-28), the Chronic Pain Coping Inventory, the Arthritis Self-efficacy Scale and the Sleep Quality Scale. An assessment was made, on the basis of clinical interviews, case histories and specific tests, of the patient sociodemographic data, comorbidity, physical exploration and other clinical indexes. An exploratory factor analysis was made, with comparisons of the clinical index scores in extreme groups of patients. The ICAF composed of 59 items was obtained, offering four factors that explain 64% of the variance, and referred to as Emotional Factor (33.7%), Physical-Activity (15%), Active Coping (9%) and Passive Coping (6.3%). A t-test between the extreme scores of these factors in the 301 patients revealed statistically significant differences in occupational status, medically unexplained syndromes, number of tender points, the six-minutes walk test, comorbidity and health care costs. This study offers a tool allowing more complete and rapid evaluation of patients with fibromyalgia. The test intrinsically evaluates the emotional aspects: anxiety and depression, and their impact upon social aspects. It also evaluates patient functional capacity, fatigue, sleep quality, pain, and the way in which the patient copes with the disease. This is achieved by means of a self-assessment questionnaire based on elements from well known tests.

Evaluating the data completeness in the Electronic Health Record after the Implementation of an Outpatient Electronic Health Record.

PubMed

Soto, Mauricio; Capurro, Daniel; Catalán, Silvia

2015-01-01

Electronic health records (EHRs) present an opportunity for quality improvement in health organitations, particularly at the primary health level. However, EHR implementation impacts clinical workflows, and physicians frequently prefer to document in a non-structured way, which ultimately hinders the ability to measure quality indicators. We present an assessment of data completeness-a key data quality indicator-during the first 12 months after the implementation of an EHR at a teaching outpatient center in Santiago, Chile.

Evaluating Management Information Systems, A Protocol for Automated Peer Review Systems

PubMed Central

Black, Gordon C.

1980-01-01

This paper discusses key issues in evaluating an automated Peer Review System. Included are the conceptual base, design, steps in planning structural components, operation parameters, criteria, costs and a detailed outline or protocol for use in the evaluation. At the heart of the Peer Review System is the criteria utilized for measuring quality. Criteria evaluation should embrace, as a minimum, appropriateness, validity and reliability, and completemess or comprehensiveness of content. Such an evaluation is not complete without determining the impact (clinical outcome) of the service system or the patient and the population served.

Inadequate Diagnostic Evaluation in Young Patients Registered with a Diagnosis of Dementia: A Nationwide Register-Based Study

PubMed Central

Salem, Lise Cronberg; Andersen, Birgitte Bo; Nielsen, T. Rune; Stokholm, Jette; Jørgensen, Martin Balslev; Waldemar, Gunhild

2014-01-01

Background Establishing a diagnosis of dementia in young patients may be complex and have significant implications for the patient. The aim of this study was to evaluate the quality of the diagnostic work-up in young patients diagnosed with dementia in the clinical routine. Methods Two hundred patients were randomly selected from 891 patients aged ≤65 years registered with a diagnosis of dementia for the first time in 2008 in Danish hospitals, and 159 medical records were available for review. Three raters evaluated their medical records for the completeness of the diagnostic work-up on which the diagnosis of dementia had been based, using evidence-based guidelines for the diagnostic evaluation of dementia as reference standards. Results According to the rater review, only 111 (70%) patients met the clinical criteria for dementia. An acceptable diagnostic work-up including all items of recommended basic diagnostic evaluation was performed in only 24%, although more often (28%) in the subgroup of patients where dementia was confirmed by raters. Conclusion This first nationwide study of unselected young patients registered with a diagnosis of dementia indicated that the concept of dementia may be misinterpreted by clinicians and that a diagnosis of dementia in the young is only rarely based on a complete basic diagnostic work-up, calling for increased competency. PMID:24711812

Computer-generated reminders and quality of pediatric HIV care in a resource-limited setting.

PubMed

Were, Martin C; Nyandiko, Winstone M; Huang, Kristin T L; Slaven, James E; Shen, Changyu; Tierney, William M; Vreeman, Rachel C

2013-03-01

To evaluate the impact of clinician-targeted computer-generated reminders on compliance with HIV care guidelines in a resource-limited setting. We conducted this randomized, controlled trial in an HIV referral clinic in Kenya caring for HIV-infected and HIV-exposed children (<14 years of age). For children randomly assigned to the intervention group, printed patient summaries containing computer-generated patient-specific reminders for overdue care recommendations were provided to the clinician at the time of the child's clinic visit. For children in the control group, clinicians received the summaries, but no computer-generated reminders. We compared differences between the intervention and control groups in completion of overdue tasks, including HIV testing, laboratory monitoring, initiating antiretroviral therapy, and making referrals. During the 5-month study period, 1611 patients (49% female, 70% HIV-infected) were eligible to receive at least 1 computer-generated reminder (ie, had an overdue clinical task). We observed a fourfold increase in the completion of overdue clinical tasks when reminders were availed to providers over the course of the study (68% intervention vs 18% control, P < .001). Orders also occurred earlier for the intervention group (77 days, SD 2.4 days) compared with the control group (104 days, SD 1.2 days) (P < .001). Response rates to reminders varied significantly by type of reminder and between clinicians. Clinician-targeted, computer-generated clinical reminders are associated with a significant increase in completion of overdue clinical tasks for HIV-infected and exposed children in a resource-limited setting.

The influence of an elective introductory clinical research course on pharmacy student interest in pursuing research-based careers.

PubMed

Overholser, Brian R; Foster, David R; Henry, Joshua R; Plake, Kimberly S; Sowinski, Kevin M

2010-11-10

To assess the impact of an elective clinical research course on second- and third-year pharmacy students' knowledge of clinical research methods, training programs, career options, and interest in pursuing postgraduate training. A 2-credit hour elective course in clinical research was designed that included lectures, discussions, workshops, and in-class presentations related to study design and implementation, protocol synthesis, research evaluation, ethical and legal considerations, data analysis, and professional opportunities involving clinical research. Learner knowledge of these topics was assessed using several methods, including 3 assignments related to research protocol, ethical documentation, and presentation. A survey instrument designed to evaluate the effect the course had on pharmacy students' knowledge of clinical research methods and interest in pursuing postgraduate training in clinical research was administered. Students who completed the elective had a greater level of familiarity with research-related topics, training options, and career opportunities (p < 0.05) and a greater interest in pursuing a career in clinical research (p < 0.05) than did students in a matched control group. Taking a 2-credit hour elective course in clinical research increased pharmacy students' interest in pursuing a career in clinical research.

Mental health literacy in primary care: Canadian Research and Education for the Advancement of Child Health (CanREACH).

PubMed

McCaffrey, Eden S N; Chang, Samuel; Farrelly, Geraldine; Rahman, Abdul; Cawthorpe, David

2017-08-01

The effectiveness of a continuing education programme in paediatric psychopharmacology designed for primary healthcare providers was objectively measured based on the assumption that training would lead to measurable changes in referral patterns and established clinical measures of referred patients. Using established, valid and reliable measures of clinical urgency embedded in to a regional healthcare system since 2002, the referrals to child and adolescent psychiatric services of physicians who participated in the training (n=99) were compared pretraining and post-training, and to non-participating/untrained referring physicians (n=7753) making referrals over the same time period. Referrals were analysed for evidence of change based on frequencies and measures of clinical urgency. Participants of the training programme also completed standardised baseline and outcome self-evaluations. Congruent with participants self-reported evaluative reports of improved knowledge and practice, analysis of referral frequency and the clinical urgency of referrals to paediatric psychiatric services over the study period indicated that trained physicians made more appropriate referrals (clinically more severe) and reduced referrals to emergency services. Quantitative clinical differences as completed by intake clinicians blind to referrals from the study group designations were observed within the trained physician group pretraining and post-training, and between the trained physician group and the unexposed physician group. The results illustrate a novel model for objectively measuring change among physicians based on training in paediatric mental health management. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Functional MR imaging and traumatic paraplegia: preliminary report.

PubMed

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

2000-12-01

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

A Novel System for Supporting Autism Diagnosis Using Home Videos: Iterative Development and Evaluation of System Design.

PubMed

Nazneen, Nazneen; Rozga, Agata; Smith, Christopher J; Oberleitner, Ron; Abowd, Gregory D; Arriaga, Rosa I

2015-06-17

Observing behavior in the natural environment is valuable to obtain an accurate and comprehensive assessment of a child's behavior, but in practice it is limited to in-clinic observation. Research shows significant time lag between when parents first become concerned and when the child is finally diagnosed with autism. This lag can delay early interventions that have been shown to improve developmental outcomes. To develop and evaluate the design of an asynchronous system that allows parents to easily collect clinically valid in-home videos of their child's behavior and supports diagnosticians in completing diagnostic assessment of autism. First, interviews were conducted with 11 clinicians and 6 families to solicit feedback from stakeholders about the system concept. Next, the system was iteratively designed, informed by experiences of families using it in a controlled home-like experimental setting and a participatory design process involving domain experts. Finally, in-field evaluation of the system design was conducted with 5 families of children (4 with previous autism diagnosis and 1 child typically developing) and 3 diagnosticians. For each family, 2 diagnosticians, blind to the child's previous diagnostic status, independently completed an autism diagnosis via our system. We compared the outcome of the assessment between the 2 diagnosticians, and between each diagnostician and the child's previous diagnostic status. The system that resulted through the iterative design process includes (1) NODA smartCapture, a mobile phone-based application for parents to record prescribed video evidence at home; and (2) NODA Connect, a Web portal for diagnosticians to direct in-home video collection, access developmental history, and conduct an assessment by linking evidence of behaviors tagged in the videos to the Diagnostic and Statistical Manual of Mental Disorders criteria. Applying clinical judgment, the diagnostician concludes a diagnostic outcome. During field evaluation, without prior training, parents easily (average rating of 4 on a 5-point scale) used the system to record video evidence. Across all in-home video evidence recorded during field evaluation, 96% (26/27) were judged as clinically useful, for performing an autism diagnosis. For 4 children (3 with autism and 1 typically developing), both diagnosticians independently arrived at the correct diagnostic status (autism versus typical). Overall, in 91% of assessments (10/11) via NODA Connect, diagnosticians confidently (average rating 4.5 on a 5-point scale) concluded a diagnostic outcome that matched with the child's previous diagnostic status. The in-field evaluation demonstrated that the system's design enabled parents to easily record clinically valid evidence of their child's behavior, and diagnosticians to complete a diagnostic assessment. These results shed light on the potential for appropriately designed telehealth technology to support clinical assessments using in-home video captured by families. This assessment model can be readily generalized to other conditions where direct observation of behavior plays a central role in the assessment process.

A double-blind randomized placebo-controlled clinical trial of squalamine ointment for tinea capitis treatment.

PubMed

Coulibaly, Oumar; Thera, Mahamadou A; Koné, Abdoulaye K; Siaka, Goïta; Traoré, Pierre; Djimdé, Abdoulaye A; Brunel, Jean-Michel; Gaudart, Jean; Piarroux, Renaud; Doumbo, Ogobara K; Ranque, Stéphane

2015-04-01

Novel treatments against for tinea capitis are needed, and the natural aminosterol squalamine is a potential topical antidermatophyte drug candidate. This phase II randomized double-blind placebo-controlled clinical trial aimed at testing the efficacy and safety of a three-week squalamine ointment regimen for the treatment of tinea capitis. Males aged 6-15 years presenting with tinea capitis were treated with either topical squalamine ointment or placebo for 3 weeks. The primary endpoint was complete clinical cure. The secondary endpoints were the occurrence of local and/or systemic adverse events, mycological cure, and partial clinical response. Prospective follow-up of clinical adverse events was performed daily. Five patients were treated with 1% squalamine ointment and 15 with placebo. No complete cure was observed. No clinical or biological adverse event was recorded. A significantly (p = 0.03) better hair-growth score, indicating a partial clinical improvement of the tinea capitis lesion, was observed in the patients treated with squalamine compared to those treated with placebo. This three-week squalamine ointment regimen was well tolerated and showed an encouraging partial clinical activity for the treatment of tinea capitis. Further studies are needed to evaluate the efficacy of topical squalamine alone against tinea corporis or in combination with a systemic antidermatophyte drug against tinea capitis.

Enhancing frontline clinical leadership in an acute hospital trust.

PubMed

Phillips, Natasha; Byrne, Geraldine

2013-09-01

To report on a leadership programme for ward managers in one National Health Service Trust that aimed to enhance their contribution to the delivery of the organisation's key objectives to support excellent patient experience. Effective ward leadership has been recognised as vital to the quality of care, resource management and interprofessional working. However, there is evidence that, at present, front-line nurse leaders are ill equipped to lead effectively and lack confidence in their ability to do so. The project aimed to provide a tailored programme for ward managers to develop their portfolio of skills to perform this pivotal role. The course contained two key elements: an integrated teaching programme to enhance leadership knowledge and skills and action learning to facilitate application to individual's own leadership practice. Both were underpinned by a change project where each individual identified, undertook and evaluated an innovation in practice. Twenty-two ward managers completed the leadership programme. Participants completed semi-structured questionnaires after each taught module. Action learning was evaluated through a combined structured and semi-structured questionnaire. All participants evaluated the programme as increasing their repertoire of leadership skills. Following completion of the programme, ward managers continue to work together as an evolving community of practice. Ward managers' development is enhanced by a programme integrating theory, action learning and completion of a ward-based project. Ward managers cannot be effectively developed in isolation. Leadership development is best supported where the organisation is also committed to developing. A leadership development programme that incorporates knowledge from within the organisation with external expertise can be an effective method to enhance front-line clinical leadership. © 2013 Blackwell Publishing Ltd.

Correlation between magnetoencephalography-based "clusterectomy" and postoperative seizure freedom.

PubMed

Vadera, Sumeet; Jehi, Lara; Burgess, Richard C; Shea, Katherine; Alexopoulos, Andreas V; Mosher, John; Gonzalez-Martinez, Jorge; Bingaman, William

2013-06-01

During the presurgical evaluation of patients with medically intractable focal epilepsy, a variety of noninvasive studies are performed to localize the hypothetical epileptogenic zone and guide the resection. Magnetoencephalography (MEG) is becoming increasingly used in the clinical realm for this purpose. No investigators have previously reported on coregisteration of MEG clusters with postoperative resection cavities to evaluate whether complete "clusterectomy" (resection of the area associated with MEG clusters) was performed or to compare these findings with postoperative seizure-free outcomes. The authors retrospectively reviewed the charts and imaging studies of 65 patients undergoing MEG followed by resective epilepsy surgery from 2009 until 2012 at the Cleveland Clinic. Preoperative MEG studies were fused with postoperative MRI studies to evaluate whether clusters were within the resected area. These data were then correlated with postoperative seizure freedom. Sixty-five patients were included in this study. The average duration of follow-up was 13.9 months, the mean age at surgery was 23.1 years, and the mean duration of epilepsy was 13.7 years. In 30 patients, the main cluster was located completely within the resection cavity, in 28 it was completely outside the resection cavity, and in 7 it was partially within the resection cavity. Seventy-four percent of patients were seizure free at 12 months after surgery, and this rate decreased to 60% at 24 months. Improved likelihood of seizure freedom was seen with complete clusterectomy in patients with localization outside the temporal lobe (extra-temporal lobe epilepsy) (p = 0.04). In patients with preoperative MEG studies that show clusters in surgically accessible areas outside the temporal lobe, we suggest aggressive resection to improve the chances for seizure freedom. When the cluster is found within the temporal lobe, further diagnostic testing may be required to better localize the epileptogenic zone.

Partnership in employee health. A workplace health program for British Columbia Public Service Agency (Canada).

PubMed

Tarride, J E; Harrington, K; Balfour, R; Simpson, P; Foord, L; Anderson, L; Lakey, W

2011-01-01

To evaluate the My Health Matters! (MHM) program, a multifaceted workplace intervention relying on education and awareness, early detection and disease management with a focus on risk factors for metabolic syndrome. The MHM program was offered to 2,000 public servants working in more than 30 worksites in British Columbia, Canada. The MHM program included a health risk assessment combined with an opportunity to attend an on-site screening and face-to-face call back visits and related on-site educational programs. Clinical and economic outcomes were collected over time in this one-year prospective study coupled with administrative and survey data. Forty three per cent of employees (N=857) completed the online HRA and 23 per cent (N=447) attended the initial clinical visit with the nurse. Risk factors for metabolic syndrome were identified in more than half of those attending the clinical visit. The number of risk factors significantly decreased by 15 per cent over six months (N=141). The cost per employee completing the HRA was $205 while the cost per employee attending the initial clinical visit was $394. Eighty-two per cent of employees would recommend the program to other employers. This study supports that workplace interventions are feasible, sustainable and valued by employees. As such, this study provides a new framework for implementing and evaluating workplace interventions focussing on metabolic disorders.

Responsiveness of clinical tests for people with neck pain.

PubMed

Jørgensen, René; Ris, Inge; Juhl, Carsten; Falla, Deborah; Juul-Kristensen, Birgit

2017-12-28

Responsiveness of a clinical test is highly relevant in order to evaluate the effect of a given intervention. However, the responsiveness of clinical tests for people with neck pain has not been adequately evaluated. The objective of the present study was to examine the responsiveness of four clinical tests which are low cost and easy to perform in a clinical setting, including the craniocervical flexion test, cervical active range of movement, test for the cervical extensors and pressure pain threshold testing. This study is a secondary analysis of data collected in a previously published randomised controlled trial. Participants were randomized to either physical training, exercises and pain education combined or pain education only. Participants were tested on the clinical tests at baseline and at 4-month follow-up. An anchor-based approach using Receiver Operator Characteristics (ROC) curves was used to evaluate responsiveness of the clinical tests. The Neck Disability Index was used to discriminate between those who had improved and those who were unchanged at the 4-month follow-up. Minimum Clinically Important Difference (MCID), together with sensitivity, specificity, positive and negative predictive values, in addition to positive and negative likelihood ratios were calculated. In total, 164 participants completed the 4 month follow up. One-hundred forty four participants were classified as unchanged whereas 20 patients were considered to be improved. Twenty-six participants didn't complete all of the clinical tests, leaving a total of 138 to be included for analyses. Area Under Curve (AUC) ranged from 0.50-0.62 for the clinical tests, and were all below an acceptable level. MCID was generally large, and the corresponding sensitivity and specificity was low with sensitivity ranging from 20 to 60%, and specificity from 54 to 86%. LR+ (0.8-2.07) and LR- (0.7-1.1) showed low diagnostic value for all variables, with PPV ranging from 12.1 to 26.1 and NPV ranging from 84.7 to 89.2. Responsiveness of the included clinical tests was generally low when using change in NDI score as the anchor from baseline to the 4-month follow up. Further investigations of responsiveness are warranted, possibly using other anchors, which to a higher degree resemble similar dimensions as the clinical tests.

Success of a Faculty Development Program for Teachers at the Mayo Clinic

PubMed Central

Lee, Staci M.; Lee, Mark C.; Reed, Darcy A.; Halvorsen, Andrew J.; Berbari, Elie F.; McDonald, Furman S.; Beckman, Thomas J.

2014-01-01

Background There has been limited research on the improvement of underperforming clinical teachers. Objective To determine whether a faculty development program could improve the evaluations of clinical teachers in an internal medicine residency program. Methods A total of 123 teachers completed faculty development at the Mayo Clinic from 2009 to 2012. The faculty enhancement and education development program (FEED) consists of 6 interactive, small group, 2-hour sessions taught by experienced Mayo Clinic faculty over 1 year. These sessions address the following competencies: asking questions, diagnosing learners, giving feedback, using teaching frameworks, recognizing learning styles, and providing clinical supervision. Resident-of-faculty Mayo teaching effectiveness (MTE) scores have previously demonstrated content, internal structure, and criterion validity. Teachers were grouped into the top 80% or the bottom 20%, according to baseline MTE scores. Mixed linear models were used to compare these groups regarding changes in MTE scores after completion of FEED. Results were adjusted for teacher age, sex, medical specialty, academic rank, and teaching awards. Results For all participants combined, the adjusted MTE scores (mean; standard error) improved from baseline (3.80; 0.04) to completion of FEED (3.93; 0.04; P < .001). However, the bottom 20% had a significantly greater improvement in scores than the top 80% (score-change difference  =  0.166, P < .001). Conclusions We describe a low-intensity faculty development intervention that benefited all clinical teachers, but was particularly effective for underperforming teachers in internal medicine. The approach may be suitable for adoption or adaptation in other graduate medical education programs. PMID:26140122

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

PubMed

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

2018-01-01

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

Availability and Use of Shared Data From Cardiometabolic Clinical Trials.

PubMed

Vaduganathan, Muthiah; Nagarur, Amulya; Qamar, Arman; Patel, Ravi B; Navar, Ann Marie; Peterson, Eric D; Bhatt, Deepak L; Fonarow, Gregg C; Yancy, Clyde W; Butler, Javed

2018-02-27

Sharing of patient-level clinical trial data has been widely endorsed. Little is known about how extensively these data have been used for cardiometabolic diseases. We sought to evaluate the availability and use of shared data from cardiometabolic clinical trials. We extracted data from ClinicalStudyDataRequest.com, a large, multisponsor data-sharing platform hosting individual patient-level data from completed studies sponsored by 13 pharmaceutical companies. From January 2013 to May 2017, the platform had data from 3374 clinical trials, of which 537 (16%) evaluated cardiometabolic therapeutics (phase 1, 36%; phase 2, 17%; phase 2/3, 1%; phase 3, 42%; phase 4, 4%). They covered 74 therapies and 398 925 patients. Diabetes mellitus (60%) and hypertension (15%) were the most common study topics. Median time from study completion to data availability was 79 months. As of May 2017, ClinicalStudyDataRequest.com had received 318 submitted proposals, of which 163 had signed data-sharing agreements. Thirty of these proposals were related to cardiometabolic therapies and requested data from 79 unique studies (15% of all trials, 29% of phase 3/4 trials). Most (96%) data requesters of cardiometabolic clinical trial data were from academic centers in North America and Western Europe, and half the proposals were unfunded. Most proposals were for secondary hypothesis-generating questions, with only 1 proposed reanalysis of the original study primary hypothesis. To date, 3 peer-reviewed articles have been published after a median of 19 months (9-32 months) from the data-sharing agreement. Despite availability of data from >500 cardiometabolic trials in a multisponsor data-sharing platform, only 15% of these trials and 29% of phase 3/4 trials have been accessed by investigators thus far, and a negligible minority of analyses have reached publication. © 2017 American Heart Association, Inc.

Leveraging Electronic Tablets for General Pediatric Care

PubMed Central

McKee, S.; Dugan, T.M.; Downs, S.M.

2015-01-01

Summary Background We have previously shown that a scan-able paper based interface linked to a computerized clinical decision support system (CDSS) can effectively screen patients in pediatric waiting rooms and support the physician using evidence based care guidelines at the time of clinical encounter. However, the use of scan-able paper based interface has many inherent limitations including lacking real time communication with the CDSS and being prone to human and system errors. An electronic tablet based user interface can not only overcome these limitations, but may also support advanced functionality for clinical and research use. However, use of such devices for pediatric care is not well studied in clinical settings. Objective In this pilot study, we enhance our pediatric CDSS with an electronic tablet based user interface and evaluate it for usability as well as for changes in patient questionnaire completion rates. Methods Child Health Improvement through Computers Leveraging Electronic Tablets or CHICLET is an electronic tablet based user interface. It is developed to augment the existing scan-able paper interface to our CDSS. For the purposes of this study, we deployed CHICLET in one outpatient pediatric clinic. Usability factors for CHICLET were evaluated via caregiver and staff surveys. Results When compared to the scan-able paper based interface, we observed an 18% increase or 30% relative increase in question completion rates using CHICLET. This difference was statistically significant. Caregivers and staff survey results were positive for using CHICLET in clinical environment. Conclusions Electronic tablets are a viable interface for capturing patient self-report in pediatric waiting rooms. We further hypothesize that the use of electronic tablet based interfaces will drive advances in computerized clinical decision support and create opportunities for patient engagement. PMID:25848409

Reporting Items for Updated Clinical Guidelines: Checklist for the Reporting of Updated Guidelines (CheckUp)

PubMed Central

Vernooij, Robin W. M.; Alonso-Coello, Pablo; Brouwers, Melissa

2017-01-01

Background Scientific knowledge is in constant development. Consequently, regular review to assure the trustworthiness of clinical guidelines is required. However, there is still a lack of preferred reporting items of the updating process in updated clinical guidelines. The present article describes the development process of the Checklist for the Reporting of Updated Guidelines (CheckUp). Methods and Findings We developed an initial list of items based on an overview of research evidence on clinical guideline updating, the Appraisal of Guidelines for Research and Evaluation (AGREE) II Instrument, and the advice of the CheckUp panel (n = 33 professionals). A multistep process was used to refine this list, including an assessment of ten existing updated clinical guidelines, interviews with key informants (response rate: 54.2%; 13/24), a three-round Delphi consensus survey with the CheckUp panel (33 participants), and an external review with clinical guideline methodologists (response rate: 90%; 53/59) and users (response rate: 55.6%; 10/18). CheckUp includes 16 items that address (1) the presentation of an updated guideline, (2) editorial independence, and (3) the methodology of the updating process. In this article, we present the methodology to develop CheckUp and include as a supplementary file an explanation and elaboration document. Conclusions CheckUp can be used to evaluate the completeness of reporting in updated guidelines and as a tool to inform guideline developers about reporting requirements. Editors may request its completion from guideline authors when submitting updated guidelines for publication. Adherence to CheckUp will likely enhance the comprehensiveness and transparency of clinical guideline updating for the benefit of patients and the public, health care professionals, and other relevant stakeholders. PMID:28072838

A randomized controlled trial comparing EMDR and CBT for obsessive-compulsive disorder.

PubMed

Marsden, Zoe; Lovell, Karina; Blore, David; Ali, Shehzad; Delgadillo, Jaime

2018-01-01

This study aimed to evaluate eye movement desensitization and reprocessing (EMDR) as a treatment for obsessive-compulsive disorder (OCD), by comparison to cognitive behavioural therapy (CBT) based on exposure and response prevention. This was a pragmatic, feasibility randomized controlled trial in which 55 participants with OCD were randomized to EMDR (n = 29) or CBT (n = 26). The Yale-Brown obsessive-compulsive scale was completed at baseline, after treatment and at 6 months follow-up. Treatment completion and response rates were compared using chi-square tests. Effect size was examined using Cohen's d and multilevel modelling. Overall, 61.8% completed treatment and 30.2% attained reliable and clinically significant improvement in OCD symptoms, with no significant differences between groups (p > .05). There were no significant differences between groups in Yale-Brown obsessive-compulsive scale severity post-treatment (d = -0.24, p = .38) or at 6 months follow-up (d = -0.03, p = .90). EMDR and CBT had comparable completion rates and clinical outcomes. Copyright © 2017 John Wiley & Sons, Ltd.

Improving the quality of cognitive screening assessments: ACEmobile, an iPad-based version of the Addenbrooke's Cognitive Examination-III.

PubMed

Newman, Craig G J; Bevins, Adam D; Zajicek, John P; Hodges, John R; Vuillermoz, Emil; Dickenson, Jennifer M; Kelly, Denise S; Brown, Simona; Noad, Rupert F

2018-01-01

Ensuring reliable administration and reporting of cognitive screening tests are fundamental in establishing good clinical practice and research. This study captured the rate and type of errors in clinical practice, using the Addenbrooke's Cognitive Examination-III (ACE-III), and then the reduction in error rate using a computerized alternative, the ACEmobile app. In study 1, we evaluated ACE-III assessments completed in National Health Service (NHS) clinics ( n  = 87) for administrator error. In study 2, ACEmobile and ACE-III were then evaluated for their ability to capture accurate measurement. In study 1, 78% of clinically administered ACE-IIIs were either scored incorrectly or had arithmetical errors. In study 2, error rates seen in the ACE-III were reduced by 85%-93% using ACEmobile. Error rates are ubiquitous in routine clinical use of cognitive screening tests and the ACE-III. ACEmobile provides a framework for supporting reduced administration, scoring, and arithmetical error during cognitive screening.

[In vivo model to evaluate the accuracy of complete-tooth spectrophotometer for dental clinics].

PubMed

Liu, Feng; Yang, Jian; Xu, Tong-Kai; Xu, Ming-Ming; Ma, Yu

2011-02-01

To test ΔE between measured value and right value from the Crystaleye complete-tooth spectrophotometer, and to evaluate the accuracy rate of the spectrophotometer. Twenty prosthodontists participated in the study. Each of them used Vita 3D-Master shadeguide to do the shade matching, and used Crystaleye complete-tooth spectrophotometer (before and after the test training) tested the middle of eight fixed tabs from shadeguide in the dark box. The results of shade matching and spectrophotometer were recorded. The accuracy rate of shade matching and the spectrophotometer before and after training were calculated. The average accuracy rate of shade matching was 49%. The average accuracy rate of the spectrophotometer before and after training was 83% and 99%. The accuracy of the spectrophotometer was significant higher than that in shade matching, and training can improve the accuracy rate.

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

PubMed

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

2018-02-01

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

An automated system for chromosome analysis. Volume 1: Goals, system design, and performance

NASA Technical Reports Server (NTRS)

Castleman, K. R.; Melnyk, J. H.

1975-01-01

The design, construction, and testing of a complete system to produce karyotypes and chromosome measurement data from human blood samples, and a basis for statistical analysis of quantitative chromosome measurement data is described. The prototype was assembled, tested, and evaluated on clinical material and thoroughly documented.

Case-Based Learning for Orofacial Pain and Temporomandibular Disorders.

ERIC Educational Resources Information Center

Clark, Glenn T.; And Others

1993-01-01

The use of interactive computer-based simulation of cases of chronic orofacial pain and temporomandibular joint disfunction patients for clinical dental education is described. Its application as a voluntary study aid in a third-year dental course is evaluated for effectiveness and for time factors in case completion. (MSE)

Use of Outpatient Endometrial Biopsy in a Population with Intellectual Disability

ERIC Educational Resources Information Center

Jaffe, Joshua S.

2008-01-01

Background: To demonstrate the feasibility of outpatient endometrial sampling to evaluate abnormal uterine bleeding in a population of women with intellectual disability. Method: Retrospective chart review was completed of all endometrial biopsies performed on women attending a dedicated gynaecology clinic for women with intellectual disability…

Selection Factors among International Medical Graduates and Psychiatric Residency Performance

ERIC Educational Resources Information Center

Shiroma, Paulo R.; Alarcon, Renato D.

2010-01-01

Objective: The authors examine the association between the selection factors used in a psychiatric residency program and subsequent clinical and academic performance among international medical graduate (IMG) candidates. Methods: The authors completed a retrospective review of application files and residency evaluations of 50 IMG residents who…

The OSCE Has Landed: One Small Step for British Psychiatry?

ERIC Educational Resources Information Center

Sauer, Justin; Hodges, Brian; Santhouse, Alastair; Blackwood, Nigel

2005-01-01

Objective: In the United Kingdom (UK), an objective structured clinical examination (OSCE) has replaced the individual patient assessment (IPA) for part 1 of the membership examination of the Royal College of Psychiatrists (MRCPsych). The authors' assessment of the OSCE was conducted. Method: Residents completed and evaluated an OSCE designed…

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 practice.

Integration and Evaluation of Substance Abuse Research Education Training (SARET) into a Master of Social Work program.

PubMed

Tuchman, Ellen; Hanley, Kathleen; Naegle, Madeline; More, Frederick; Bereket, Sewit; Gourevitch, Marc N

2017-01-01

The Substance Abuse Research and Education Training (SARET) program is funded by the National Institutes of Drug Abuse in 2006 as a novel approach to spark interest in substance abuse research among medical, dental, nursing, and social work graduate students through a Web-based curriculum and research mentorships. This report presents the initial integration of the intervention in a Master of Social Work (MSW) program, the components of the program, and the mixed-methods evaluation of its effect on students' attitudes towards substance abuse research and treatment. SARET comprises 2 main components: stipend-supported research mentorships and a Web-based module series, consisting of 6 interactive, multimedia modules addressing core SA research topics, delivered via course curricula and in the research mentorships. An initial evaluation was designed to assess SARET's acceptability and short-term impact on participants' interest in SA research. The components of this Web-based curriculum evaluation include focus group feedback on the relevance of the modules to SW students, number of courses into which the modules were integrated with number of module completions, changes in interest in SA research associated with module completion. The full series of Web-based modules has been integrated across several courses in the social work curriculum, and social work students have become integral participants in the summer mentored research experience. One hundred eighteen students completed at least 1 module and 42 students completed all 6 modules. Neurobiology, Screening, and Epidemiology were the most widely viewed modules. Students reported positive impact on their vision of SA-related clinical care, more positive attitudes about conducting research, and in some cases, change in career. The SARET program's modules and summer mentored research increased clinical and research interest related to SUDs, as well as interprofessional attitudes among social work students. Participants have shown some early research success. Longer-term follow-up will enable us to continue to assess the effectiveness of the program.

Renaissance of antibiotics against difficult infections: Focus on oritavancin and new ketolides and quinolones.

PubMed

Van Bambeke, Françoise

2014-11-01

Lipoglycopeptide, ketolide, and quinolone antibiotics are currently in clinical development, with specific advantages over available molecules within their respective classes. The lipoglycopeptide oritavancin is bactericidal against MRSA, vancomycin-resistant enterococci, and multiresistant Streptococcus pneumoniae, and proved effective and safe for the treatment of acute bacterial skin and skin structure infection (ABSSSI) upon administration of a single 1200 mg dose (two completed phase III trials). The ketolide solithromycin (two phase III studies recruiting for community-acquired pneumonia) shows a profile of activity similar to that of telithromycin, but in vitro data suggest a lower risk of hepatotoxicity, visual disturbance, and aggravation of myasthenia gravis due to reduced affinity for nicotinic receptors. Among quinolones, finafloxacin and delafloxacin share the unique property of an improved activity in acidic environments (found in many infection sites). Finafloxacin (phase II completed; activity profile similar to that of ciprofloxacin) is evaluated for complicated urinary tract and Helicobacter pylori infections. The other quinolones (directed towards Gram-positive pathogens) show improved activity on MRSA and multiresistant S. pneumoniae compared to current molecules. They are in clinical evaluation for ABSSSI (avarofloxacin (phase II completed), nemonoxacin and delafloxacin (ongoing phase III)), respiratory tract infections (zabofloxacin and nemonoxacin (ongoing phase III)), or gonorrhea (delafloxacin).

Topical application of ALA PDT for the treatment of moderate to severe acne vulgaris

NASA Astrophysics Data System (ADS)

Wang, Xiu-Li; Wang, Hong-Wei; Zhang, Ling-Lin; Su, Lina; Guo, Ming-Xia; Huang, Zheng

2009-06-01

Objectives: To evaluate the effectiveness of topical 5-aminolevulinic acid (ALA)- medicated photodynamic therapy (ALA PDT) for the treatment of moderate to severe acne vulgaris. Methods: Sixteen Chinese patients with moderate to severe facial acne were treated with 1-3 courses of ALA PDT. ALA cream (3%) was freshly prepared and applied to acne lesions for 3-4 h. The lesions were irradiated by a 635 nm diode laser at dose levels of 60 - 80 J/cm2 at 100 mW/cm2. Clinical assessments were conducted before and after treatment up to 3 months. Results: All patents showed response to ALA PDT. Complete clearance was seen in 10 patients (62.5%) and partial clearance in 6 patients (37.5%). One case showed recurrence after complete clearance at 2 months and another two showed recurrence after complete clearance at 3 months. However, the number of new lesions were significantly reduced. Adverse effects were minimal. Conclusions: The results of this preliminary clinical study is encouraging. ALA PDT is a simple, safe and useful therapeutic option for the treatment of moderate to severe acne. Further studies to evaluate the treatment with a larger number of patients and for a longer period of follow-up are needed.

[Giant epidermoid cyst of the skull with extra and intracranial extension. A case report].

PubMed

Akhaddar, A; Gazzaz, M; El Mostarchid, B; Kadiri, B; Lrhezzioui, J; Boucetta, M

2002-09-01

Intradiploic epidermoid cyst of the skull is a rare clinical entity that can exceptionally grow to a large size with intracranial extension. The authors report the case of a 38-year-old man with a giant epidermoid cyst of the parietal bone with extra and intracranial extension, presenting with focal neurological symptoms. The diagnosis was suggested at imaging (skull radiographs, CT and MRI), and confirmed at histology. Complete removal of the cyst and its capsule was performed followed by cranioplasty. Postoperatively, the patient was discharged free of symptoms. CT scan provides good evaluation of the bony lesion and may suggest intracranial extension. MRI is superior for evaluation of cerebral compression. The pathogenesis, clinical presentation, diagnostic evaluation and therapeutic management of these rare lesions are reviewed.

An audit of request forms submitted in a multidisciplinary diagnostic center in Lagos.

PubMed

Oyedeji, Olufemi Abiola; Ogbenna, Abiola Ann; Iwuala, Sandra Omozehio

2015-01-01

Request forms are important means of communication between physicians and diagnostic service providers. Pre-analytical errors account for over two thirds of errors encountered in diagnostic service provision. The importance of adequate completion of request forms is usually underestimated by physicians which may result in medical errors or delay in instituting appropriate treatment. The aim of this study was to audit the level of completion of request forms presented at a multidisciplinary diagnostic center. A review of all requests forms for investigations which included radiologic, laboratory and cardiac investigations received between July and December 2011 was performed to assess their level of completeness. The data was entered into a spreadsheet and analyzed. Only 1.3% of the 7,841 request forms reviewed were fully completed. Patient's names, the referring physician's name and gender were the most completed information on the forms evaluated with 99.0%, 99.0% and 90.3% completion respectively. Patient's age was provided in 68.0%, request date in 88.2%, and clinical notes/ diagnosis in 65.9% of the requests. Patient's full address was provided in only 5.6% of requests evaluated. This study shows that investigation request forms are inadequately filled by physicians in our environment. Continuous medical education of physicians on the need for adequate completion of request forms is needed.

Virtual patients design and its effect on clinical reasoning and student experience: a protocol for a randomised factorial multi-centre study.

PubMed

Bateman, James; Allen, Maggie E; Kidd, Jane; Parsons, Nick; Davies, David

2012-08-01

Virtual Patients (VPs) are web-based representations of realistic clinical cases. They are proposed as being an optimal method for teaching clinical reasoning skills. International standards exist which define precisely what constitutes a VP. There are multiple design possibilities for VPs, however there is little formal evidence to support individual design features. The purpose of this trial is to explore the effect of two different potentially important design features on clinical reasoning skills and the student experience. These are the branching case pathways (present or absent) and structured clinical reasoning feedback (present or absent). This is a multi-centre randomised 2 x 2 factorial design study evaluating two independent variables of VP design, branching (present or absent), and structured clinical reasoning feedback (present or absent).The study will be carried out in medical student volunteers in one year group from three university medical schools in the United Kingdom, Warwick, Keele and Birmingham. There are four core musculoskeletal topics. Each case can be designed in four different ways, equating to 16 VPs required for the research. Students will be randomised to four groups, completing the four VP topics in the same order, but with each group exposed to a different VP design sequentially. All students will be exposed to the four designs. Primary outcomes are performance for each case design in a standardized fifteen item clinical reasoning assessment, integrated into each VP, which is identical for each topic. Additionally a 15-item self-reported evaluation is completed for each VP, based on a widely used EViP tool. Student patterns of use of the VPs will be recorded.In one centre, formative clinical and examination performance will be recorded, along with a self reported pre and post-intervention reasoning score, the DTI. Our power calculations indicate a sample size of 112 is required for both primary outcomes. This trial will provide robust evidence to support the effectiveness of different designs of virtual patients, based on student performance and evaluation. The cases and all learning materials will be open access and available on a Creative Commons Attribution-Share-Alike license.

Collagen gel droplet-embedded culture drug sensitivity test for adjuvant chemotherapy after complete resection of non-small-cell lung cancer.

PubMed

Inoue, Masayoshi; Maeda, Hajime; Takeuchi, Yukiyasu; Fukuhara, Kenjiro; Shintani, Yasushi; Funakoshi, Yasunobu; Funaki, Soichiro; Nojiri, Takashi; Kusu, Takashi; Kusumoto, Hidenori; Kimura, Toru; Okumura, Meinoshin

2018-04-01

We conducted a prospective clinical study to individualize adjuvant chemotherapy after complete resection of non-small-cell lung cancer (NSCLC), based on the drug sensitivity test. Patients with resectable c-stage IB-IIIA NSCLC were registered between 2005 and 2010. We performed the collagen gel droplet-embedded culture drug sensitivity test (CD-DST) on a fresh surgical specimen to assess in vitro chemosensitivity and evaluated the prognostic outcome after adjuvant chemotherapy with carboplatin/paclitaxel based on the CD-DST. Among 92 registered patients, 87 were eligible for inclusion in the analysis. The success rate of CD-DST was 86% and chemosensitivity to carboplatin and/or paclitaxel was evident in 57 (76%) of the 75 patients. Adjuvant chemotherapy was completed in 22 (73%) of 30 patients. The 5-year overall survival rates were 71, 73, and 75% for all, CD-DST success, and chemosensitive patients, respectively. The 5-year disease-free survival and overall survival rates of the chemosensitive patients who completed adjuvant chemotherapy using carboplatin/paclitaxel were 68 and 82%, respectively. The 5-year disease-free survival and overall survival rates of the patients with stage II-IIIA chemosensitive NSCLC were 58 and 75%, respectively. Comparative analyses of the chemosensitive and non-chemosensitive/CD-DST failure groups showed no significant survival difference. CD-DST can be used to evaluate chemosensitivity after lung cancer surgery; however, its clinical efficacy for assessing individualized treatment remains uncertain.

Simulated patients in audiology education: student reports.

PubMed

Naeve-Velguth, Susan; Christensen, Sara A; Woods, Suzanne

2013-09-01

Despite increased attention in recent years to audiology counseling education, students remain concerned about their abilities to interact with patients in challenging situations, such as when breaking difficult news. Simulated patients, or actors trained to portray patients in clinical scenarios, have been used for many years in medical schools to teach and assess students' interpersonal skills, and are just beginning to be used in audiology programs. Although research suggests that medical students value simulated patient experiences, little is known about whether the same is true for audiology students. The purpose of this study was to survey audiology students who had completed a simulated patient counseling experience as part of their graduate coursework at Central Michigan University, to learn about their experiences and views of this instructional format. This study used descriptive and comparative statistics to report student observations and to determine if student responses to evaluative questions differed from chance. Study participants included 29 audiology students who had completed a "breaking difficult news" simulated patient experience as part of their required graduate coursework in patient counseling. Participants completed an online survey that included seven evaluative five-point Likert-scale questions about their simulated patient counseling experience. Participants also completed one multiple-choice question on suggestions for future simulated-patient sessions. For each of the seven evaluative questions, a majority of participants (76-100%) responded positively, agreeing or strongly agreeing that the experience was helpful to their learning. For each of these evaluative questions, a χ² analysis revealed that the distribution of positive (i.e., strongly agree and agree) to nonpositive (i.e., neutral, disagree, and strongly disagree) responses differed significantly from chance (p < .0001, df = 1). The results also indicated that when asked which of several suggested clinical scenarios would be helpful for future sessions, simulations of challenging patient types (i.e., hostile, rambling, and noncommunicative patients) were supported by most (62-90%) respondents. The results of the present study are consistent with findings of medical students' positive perceptions of simulated patient experiences as well as those previously reported for audiology students. Together, these data support the continued use of simulated patients as a method of instruction for audiology counseling education for breaking difficult news, and suggest a potential value of using simulated patient interactions for training counseling skills in other clinical situations and scenarios. American Academy of Audiology.

Timing of Emergency Medicine Student Evaluation Does Not Affect Scoring.

PubMed

Hiller, Katherine M; Waterbrook, Anna; Waters, Kristina

2016-02-01

Evaluation of medical students rotating through the emergency department (ED) is an important formative and summative assessment method. Intuitively, delaying evaluation should affect the reliability of this assessment method, however, the effect of evaluation timing on scoring is unknown. A quality-improvement project evaluating the timing of end-of-shift ED evaluations at the University of Arizona was performed to determine whether delay in evaluation affected the score. End-of-shift ED evaluations completed on behalf of fourth-year medical students from July 2012 to March 2013 were reviewed. Forty-seven students were evaluated 547 times by 46 residents and attendings. Evaluation scores were means of anchored Likert scales (1-5) for the domains of energy/interest, fund of knowledge, judgment/problem-solving ability, clinical skills, personal effectiveness, and systems-based practice. Date of shift, date of evaluation, and score were collected. Linear regression was performed to determine whether timing of the evaluation had an effect on evaluation score. Data were complete for 477 of 547 evaluations (87.2%). Mean evaluation score was 4.1 (range 2.3-5, standard deviation 0.62). Evaluations took a mean of 8.5 days (median 4 days, range 0-59 days, standard deviation 9.77 days) to complete. Delay in evaluation had no significant effect on score (p = 0.983). The evaluation score was not affected by timing of the evaluation. Variance in scores was similar for both immediate and delayed evaluations. Considerable amounts of time and energy are expended tracking down delayed evaluations. This activity does not impact a student's final grade. Copyright © 2016 Elsevier Inc. All rights reserved.

Child and Adolescent Behavior Inventory (CABI): Standardization for Age 6-17 Years and First Clinical Application

PubMed Central

Cianchetti, Carlo; Pasculli, Marcello; Pittau, Andrea; Campus, Maria Grazia; Carta, Valeria; Littarru, Roberta; Fancello, Giuseppina Sannio; Zuddas, Alessandro; Ledda, Maria Giuseppina

2017-01-01

Background: The Child and Adolescent Behavior Inventory (CABI) is a questionnaire designed to collect information from the parents of children and adolescents, both for the preparation of screening and epidemiological studies and for clinical evaluation. It has been published in CPEMH in 2013, with the first data on 8-10 years old school children. Here we report an extended standardization on a school population 6-17 years old and the first results of the application in a clinical sample. Methods: Parents, after giving their informed consent, answered to the questionnaire. Complete and reliable data were obtained from the parents of 659 school children and adolescents 6-17 y.o., with a balanced distribution of gender. Moreover, in a population of 84 patients, the results with the CABI were compared with the clinical evaluation and the CBCL. Results: In the school population, scores were different in relation to gender and age. The values of externalizing disorders were higher in males, with the highest values for ADHD in the 6-10 y.o. children. On the contrary, the scores of internalizing disorders and of eating disorders tended to be slightly higher in females. In the clinical population, scores at the CABI were in agreement with the clinical evaluation in 84% cases for depressive symptoms (compared to CBCL 66%), 53% for anxiety symptoms (CBCL 42%) and 87% for ODD (CBCL 69%), differences, however; without statistical significance (chi square). Conclusion: The study obtained normative data for the CABI and gave information of the behavioral differences in relation to age and gender of the school population as evaluated by parents/caregivers. Clinically, the CABI provided useful information for the clinical evaluation of the patient, sometimes with better agreement with the final diagnosis compared to the CBCL. PMID:28458717

Integration of physical abuse clinical decision support into the electronic health record at a Tertiary Care Children's Hospital.

PubMed

Suresh, Srinivasan; Saladino, Richard A; Fromkin, Janet; Heineman, Emily; McGinn, Tom; Richichi, Rudolph; Berger, Rachel P

2018-04-12

To evaluate the effect of a previously validated electronic health record-based child abuse trigger system on physician compliance with clinical guidelines for evaluation of physical abuse. A randomized controlled trial (RCT) with comparison to a preintervention group was performed. RCT-experimental subjects' providers received alerts with a direct link to a physical abuse-specific order set. RCT-control subjects' providers had no alerts, but could manually search for the order set. Preintervention subjects' providers had neither alerts nor access to the order set. Compliance with clinical guidelines was calculated. Ninety-nine preintervention subjects and 130 RCT subjects (73 RCT-experimental and 57 RCT-control) met criteria to undergo a physical abuse evaluation. Full compliance with clinical guidelines was 84% pre-intervention, 86% in RCT-control group, and 89% in RCT-experimental group. The physical abuse order set was used 43 times during the 7-month RCT. When the abuse order set was used, full compliance was 100%. The proportion of cases in which there was partial compliance decreased from 10% to 3% once the order set became available (P = .04). Male gender, having >10 years of experience and completion of a pediatric emergency medicine fellowship were associated with increased compliance. A child abuse clinical decision support system comprised of a trigger system, alerts and a physical abuse order set was quickly accepted into clinical practice. Use of the physical abuse order set always resulted in full compliance with clinical guidelines. Given the high baseline compliance at our site, evaluation of this alert system in hospitals with lower baseline compliance rates will be more valuable in assessing the efficacy in adherence to clinical guidelines for the evaluation of suspected child abuse.

Completeness of reporting of patient-relevant clinical trial outcomes: comparison of unpublished clinical study reports with publicly available data.

PubMed

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-10-01

Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as "completely reported" or "incompletely reported." For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary.

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy.

PubMed

Nayak, Madhabika B; Korcha, Rachael A; Kaskutas, Lee A; Kaskustas, Lee A; Avalos, Lyndsay A

2014-11-25

Recommended screening and brief intervention (SBI) for alcohol use during pregnancy is impeded by high patient loads and limited resources in public health settings. We evaluated the feasibility, acceptability and validity of a new self-administered, single-session, bilingual, computerized Screening and Brief Intervention (SBI) program for alcohol and sugar sweetened beverage (SSB) use in pregnancy. We developed and tested the computerized SBI program at a public health clinic with 290 pregnant women. Feasibility, acceptability, and validity measures were included in the program which had several modules, including those on demographics, health and beverage use. Time to complete the program and user experience items were used to determine program feasibility and acceptability. Validity analyses compared proportions of prenatal alcohol use identified by the program versus in-person screening by clinic staff. Most program users (87%, n = 251) completed the entire program; 91% (n = 263) completed the key screening and brief intervention modules. Most users also completed the program in ten to fifteen minutes. Program users reported that the program was easy to use (97%), they learned something new (88%), and that they would share what they learned with others (83%) and with their doctors or clinic staff (76%). Program acceptability did not differ by age, education, or type of beverage intervention received. The program identified alcohol use in pregnancy among 21% of users, a higher rate than the 13% (p < .01) found via screening by clinic staff. Computerized Screening and Brief Intervention for alcohol and SSB use in public health clinics is feasible and acceptable to English and Spanish speaking pregnant women and can efficiently identify prenatal alcohol use.

Developing and using a rubric for evaluating evidence-based medicine point-of-care tools.

PubMed

Shurtz, Suzanne; Foster, Margaret J

2011-07-01

The research sought to establish a rubric for evaluating evidence-based medicine (EBM) point-of-care tools in a health sciences library. The authors searched the literature for EBM tool evaluations and found that most previous reviews were designed to evaluate the ability of an EBM tool to answer a clinical question. The researchers' goal was to develop and complete rubrics for assessing these tools based on criteria for a general evaluation of tools (reviewing content, search options, quality control, and grading) and criteria for an evaluation of clinical summaries (searching tools for treatments of common diagnoses and evaluating summaries for quality control). Differences between EBM tools' options, content coverage, and usability were minimal. However, the products' methods for locating and grading evidence varied widely in transparency and process. As EBM tools are constantly updating and evolving, evaluation of these tools needs to be conducted frequently. Standards for evaluating EBM tools need to be established, with one method being the use of objective rubrics. In addition, EBM tools need to provide more information about authorship, reviewers, methods for evidence collection, and grading system employed.

Post-deployment usability evaluation of a radiology workstation.

PubMed

Jorritsma, Wiard; Cnossen, Fokie; Dierckx, Rudi A; Oudkerk, Matthijs; Van Ooijen, Peter M A

2016-01-01

To determine the number, nature and severity of usability issues radiologists encounter while using a commercially available radiology workstation in clinical practice, and to assess how well the results of a pre-deployment usability evaluation of this workstation generalize to clinical practice. The usability evaluation consisted of semi-structured interviews and observations of twelve users using the workstation during their daily work. Usability issues and positive usability findings were documented. Each issue was given a severity rating and its root cause was determined. Results were compared to the results of a pre-deployment usability evaluation of the same workstation. Ninety-two usability issues were identified, ranging from issues that cause minor frustration or delay, to issues that cause significant delays, prevent users from completing tasks, or even pose a potential threat to patient safety. The results of the pre-deployment usability evaluation had limited generalizability to clinical practice. This study showed that radiologists encountered a large number and a wide variety of usability issues when using a commercially available radiology workstation in clinical practice. This underlines the need for effective usability engineering in radiology. Given the limitations of pre-deployment usability evaluation in radiology, which were confirmed by our finding that the results of a pre-deployment usability evaluation of this workstation had limited generalizability to clinical practice, it is vital that radiology workstation vendors devote significant resources to usability engineering efforts before deployment of their workstation, and to continue these efforts after the workstation is deployed in a hospital. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Physical Medicine and Rehabilitation Resident Use of iPad Mini Mobile Devices.

PubMed

Niehaus, William; Boimbo, Sandra; Akuthota, Venu

2015-05-01

Previous research on the use of tablet devices in residency programs has been undertaken in radiology and medicine or with standard-sized tablet devices. With new, smaller tablet devices, there is an opportunity to assess their effect on resident behavior. This prospective study attempts to evaluate resident behavior after receiving a smaller tablet device. To evaluate whether smaller tablet computers facilitate residents' daily tasks. Prospective study that administered surveys to evaluate tablet computer use. Residency program. Thirteen physical medicine and rehabilitation residents. Residents were provided 16-GB iPad Minis and surveyed with Redcap to collect usage information at baseline, 3, and 6 months. Survey analysis was conducted using SAS (SAS, Cary, NC) for descriptive analysis. To evaluate multiple areas of resident education, the following tasks were selected: accessing e-mail, logging duty hours, logging procedures, researching clinical information, accessing medical journals, reviewing didactic presentations, and completing evaluations. Then, measurements were taken of: (1) residents' response to how tablet computers made it easier to access the aforementioned tasks; and (2) residents' response to how tablet computers affected the frequency they performed the aforementioned tasks. After being provided tablet computers, our physical medicine and rehabilitation residents reported significantly greater access to e-mail, medical journals, and didactic material. Also, receiving tablet computers was reported to increase the frequency that residents accessed e-mail, researched clinical information, accessed medical journals, reviewed didactic presentations, and completed evaluations. After receiving a tablet computer, residents reported an increase in the use of calendar programs, note-taking programs, PDF readers, online storage programs, and file organization programs. These physical medicine and rehabilitation residents reported tablet computers increased access to e-mail, presentation material, and medical journals. Tablet computers also were reported to increase the frequency residents were able to complete tasks associated with residency training. Copyright © 2015 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

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

PubMed

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

2001-09-01

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

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

PubMed

Chun, Natalie; Park, Minjung

2013-04-01

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

A Virtual Patient Software Program to Improve Pharmacy Student Learning in a Comprehensive Disease Management Course

PubMed Central

Casale, Jillian P.; Skirvin, J. Andrew; DiVall, Margarita V.

2013-01-01

Objective. To implement and assess the impact of a virtual patient pilot program on pharmacy students’ clinical competence skills. Design. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessment. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students’ posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Conclusion. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes. PMID:24159213

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

PubMed

Wang, Dongwen; Luque, Amneris E

2016-01-01

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

High-intensity focused ultrasound (HIFU) in patients with solid malignancies: evaluation of feasibility, local tumour response and clinical results.

PubMed

Orgera, G; Monfardini, L; Della Vigna, P; Zhang, L; Bonomo, G; Arnone, P; Padrenostro, M; Orsi, F

2011-08-01

The purpose of this study was to evaluate the safety and efficacy of ultrasound-guided high-intensity focused ultrasound (USgHIFU) for ablation of solid tumours without damaging the surrounding structures. A specific written informed consent was obtained from every patient before treatment. From September 2008 to April 2009, 22 patients with 29 lesions were treated: nine patients with liver and/or soft-tissue metastases from colorectal carcinoma (CRC), six with pancreatic solid lesions, three with liver and/or bone metastases from breast cancer, one with osteosarcoma, one with muscle metastasis from lung cancer, one with iliac metastasis from multiple myeloma and one with abdominal liposarcoma. The mean diameter of tumours was 4.2 cm. All patients were evaluated 1 day, 1 month and 3 months after HIFU treatment by multidetector computed tomography (MDCT), positron-emission tomography (PET)-CT and clinical evaluation. The treatment time and adverse events were recorded. All patients had one treatment. Average treatment and sonication times were, respectively, 162.7 and 37.4 min. PET-CT or/and MDCT showed complete response in 11/13 liver metastases; all bone, soft-tissue and pancreatic lesions were palliated in symptoms, with complete response to PET-CT, MDCT or magnetic resonance imaging (MRI); the liposarcoma was almost completely ablated at MRI. Local oedema was observed in three patients. No other side effects were observed. All patients were discharged 1-3 days after treatment. According to our preliminary experience in a small number of patients, we conclude that HIFU ablation is a safe and feasible technique for locoregional treatment and is effective in pain control.

Effect of 5-Day Nitrofurantoin vs Single-Dose Fosfomycin on Clinical Resolution of Uncomplicated Lower Urinary Tract Infection in Women: A Randomized Clinical Trial.

PubMed

Huttner, Angela; Kowalczyk, Anna; Turjeman, Adi; Babich, Tanya; Brossier, Caroline; Eliakim-Raz, Noa; Kosiek, Katarzyna; Martinez de Tejada, Begoña; Roux, Xavier; Shiber, Shachaf; Theuretzbacher, Ursula; von Dach, Elodie; Yahav, Dafna; Leibovici, Leonard; Godycki-Cwirko, Maciek; Mouton, Johan W; Harbarth, Stephan

2018-05-01

The use of nitrofurantoin and fosfomycin has increased since guidelines began recommending them as first-line therapy for lower urinary tract infection (UTI). To compare the clinical and microbiologic efficacy of nitrofurantoin and fosfomycin in women with uncomplicated cystitis. Multinational, open-label, analyst-blinded, randomized clinical trial including 513 nonpregnant women aged 18 years and older with symptoms of lower UTI (dysuria, urgency, frequency, or suprapubic tenderness), a positive urine dipstick result (with detection of nitrites or leukocyte esterase), and no known colonization or previous infection with uropathogens resistant to the study antibiotics. Recruitment took place from October 2013 through April 2017 at hospital units and outpatient clinics in Geneva, Switzerland; Lodz, Poland; and Petah-Tiqva, Israel. Participants were randomized in a 1:1 ratio to oral nitrofurantoin, 100 mg 3 times a day for 5 days (n = 255), or a single 3-g dose of oral fosfomycin (n = 258). They returned 14 and 28 days after therapy completion for clinical evaluation and urine culture collection. The primary outcome was clinical response in the 28 days following therapy completion, defined as clinical resolution (complete resolution of symptoms and signs of UTI without prior failure), failure (need for additional or change in antibiotic treatment due to UTI or discontinuation due to lack of efficacy), or indeterminate (persistence of symptoms without objective evidence of infection). Secondary outcomes included bacteriologic response and incidence of adverse events. Among 513 patients who were randomized (median age, 44 years [interquartile range, 31-64]), 475 (93%) completed the trial and 377 (73%) had a confirmed positive baseline culture. Clinical resolution through day 28 was achieved in 171 of 244 patients (70%) receiving nitrofurantoin vs 139 of 241 patients (58%) receiving fosfomycin (difference, 12% [95% CI, 4%-21%]; P = .004). Microbiologic resolution occurred in 129 of 175 (74%) vs 103 of 163 (63%), respectively (difference, 11% [95% CI, 1%-20%]; P = .04). Adverse events were few and primarily gastrointestinal; the most common were nausea and diarrhea (7/248 [3%] and 3/248 [1%] in the nitrofurantoin group vs 5/247 [2%] and 5/247 [1%] in the fosfomycin group, respectively). Among women with uncomplicated UTI, 5-day nitrofurantoin, compared with single-dose fosfomycin, resulted in a significantly greater likelihood of clinical and microbiologic resolution at 28 days after therapy completion. ClinicalTrials.gov Identifier: NCT01966653.

Impact of Evidence-Based Dentistry Workshops on Educators' Use of Evidence in Teaching and Practice: A Pilot Study.

PubMed

Moreira, Narjara C F; Leonardi-Dutra, Kamile; Feres, Murilo F N; Colangelo, Erica A M; Balevi, Ben; Matthews, Debora; Flores-Mir, Carlos

2018-06-01

The aims of this pilot study were to evaluate the short-term impact of evidence-based dentistry (EBD) workshops on educators' use of clinical evidence in their clinical practice and educational activities and to identify barriers they encountered in implementing evidence in their teaching and clinical practice. Between April 2012 and January 2014, a series of EBD workshops was delivered to 31 dental faculty members and postdoctoral students at three Canadian dental schools. Survey I, assessing participants' perceptions of various aspects of the workshops, was administered immediately following the workshops. Survey II, evaluating the impact of the workshops on participants' EBD implementation, was conducted 10 to 31 months after their completion. Survey I was completed by all 31 participants (100% response rate); their mean scores ranged from 3.94 to 4.65 on a five-point scale. Survey II was completed by 20 participants (64.5% response rate; five postdoctoral students and 15 faculty members), using an online 20-item questionnaire. Of the respondents, 19 (95%) reported implementing EBD in their professional activities at that time, and 14 (70%) stated that the workshops had positively helped with EBD implementation. Eight respondents (40%) reported having experienced barriers to EBD implementation, while 15 (75%) reported that their patients/students welcomed use of EBD. The respondents reported believing that strategies such as increasing EBD education and dissemination and improving quality and accessibility of evidence would facilitate the transition to EBD practice. Reported barriers to EBD implementation included resistance and criticism from colleagues, difficulty in changing current practice model, and lack of time.

Encopresis: long-term clinical outcome of 67 cases.

PubMed

Unal, Fatih; Pehlivantürk, Berna

2005-01-01

In this study we attempted to investigate the outcome of encopresis and to determine factors affecting prognosis. The sample consisted of 52 boys (77.6%) and 15 girls (22.4%) diagnosed as encopresis according to DSM IV diagnostic criteria. These patients were evaluated six years after their initial examination in the Department of Child Psychiatry. Clinical and demographical data were compared between initial and follow-up interviews and between patients with complete recovery and others. Fifty-six patients (83.6%) recovered completely and 11 (16.4%) continued to be encopretic after six years. Good school performance (p<0.005), high levels of parental education (p<0.005) and absence of constipation (p<0.05) were associated with favorable outcome. In addition, secondary encopretics who were diagnosed within a year from onset of the symptom recovered significantly earlier (p<0.001). Encopresis is a chronic disorder and complete recovery rates tend to increase with time. Families and primary health care providers should be informed about the treatment possibilities of encopresis for early intervention.

Evaluation of an Outpatient Rehabilitative Program to Address Mobility Limitations Among Older Adults

PubMed Central

Brown, Lorna G.; Ni, Meng; Schmidt, Catherine T.; Bean, Jonathan F.

2017-01-01

Abstract Live Long Walk Strong is a clinical demonstration program for community-dwelling older patients. It was designed to be consistent with current fall prevention guidelines and reimbursed under the Medicare model. Patients were screened within primary care and referred to a physiatrist followed by systematic assessment and treatment within an outpatient rehabilitative care setting. The treatment included behavioral modification, fall prevention education, community/home exercise integration, and exercise targeting strength, power, flexibility, balance, and endurance. Treatment duration and frequency varied with each patient based on baseline presentation, clinical judgment, and patient preference. Program feasibility and preliminary effectiveness were evaluated by assessing participation and changes in physical performance, respectively. There were 266 patients referred to the program, and 147 were willing to participate. Of these, 116 patients completed all scheduled visits (10.8 ± 3.9 visits). The noncompleters (n = 31) had a higher rate of falls in the previous 6 months and lower baseline Short Physical Performance Battery composite score. At the completion of care, the adjusted mean change in Short Physical Performance Battery was 1.66 units, surpassing a large clinically meaningful threshold (1 unit). The Live Long Walk Strong program appears to be feasible to implement and demonstrates preliminary effectiveness in enhancing mobility among older adults. PMID:28079616

Evaluation of the Commitment to Living (CTL) curriculum: a 3-hour training for mental health professionals to address suicide risk.

PubMed

Pisani, Anthony R; Cross, Wendi F; Watts, Arthur; Conner, Kenneth

2012-01-01

Finding effective and efficient options for training mental health professionals to assess and manage suicide risk is a high priority. To test whether an innovative, brief workshop can improve provider knowledge, confidence, and written risk assessment in a multidisciplinary sample of ambulatory and acute services professionals and trainees. We conducted a pre/post evaluation of a 3 h workshop designed to improve clinical competence in suicide risk assessment by using visual concept mapping, medical records documentation, and site-specific crisis response options. Participants (N = 338 diverse mental health professionals) completed pre- and postworkshop questionnaires measuring their knowledge and confidence. Before and after the workshop, participants completed documentation for a clinical vignette. Trained coders rated the quality of risk assessment formulation before and after training. Participants' knowledge, confidence, and objectively-rated documentation skills improved significantly (p < .001), with large effect sizes. Participants' expectation of their ability to transfer workshop content to their clinical practice was high (mean = 4.10 on 1-5 scale). Commitment to Living is a promising, innovative, and efficient curriculum for educating practicing clinicians to assess and respond to suicide risk. Well-designed, brief, suicide risk management programs can improve clinicians' knowledge, confidence, and skill.

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

PubMed

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

2011-10-01

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

Working together: Using a unique approach to evaluate an interactive and clinic-based longitudinal interprofessional education experience with 13 professions.

PubMed

Thompson, Britta M; Bratzler, Dale W; Fisher, Mark J; Torres, Amie; Faculty, Epic; Sparks, Rhonda A

2016-11-01

Interprofessional education (IPE) involving an interactive and longitudinal clinic experience at an inner-city charitable clinic from September to May 2013/2014 was evaluated. Pre-, mid-, and post-intervention data were collected from students in 13 different professions including medicine (medical and physician assistant), dentistry (dental and dental hygiene), nursing (undergraduate and clinical nurse specialist), public health, pharmacy, physical therapy, occupational therapy, nutritional sciences, speech and language pathology, and social work. To evaluate their interprofessional attitudes, students completed the TeamSTEPPS Teamwork Attitudes Questionnaire (T-TAQ) and Readiness for Interprofessional Learning Scale (RIPLS). They also completed a unique measure, healthcare professionals circles diagrams (HPCDs), that indicated student conceptualisation of a healthcare team caring for a complex patient, along with perception of their team's progress towards meeting patient goals. Results from the T-TAQ and RIPLS scores indicated small but significant increases from pre- to post-intervention (p = 0.005 and 0.012, respectively). Analysis of the HPCDs revealed significant increases in students' perceptions of the types of interprofessional team members, relationships, and communication between professions to provide medical care to patients (p < 0.01). Most HPCDs included pharmacists, nurses, and physicians as part of the care team at all time points. Students significantly increased their inclusion of dentistry, public health, social work, and physician assistants as members of the healthcare team from pre- to post-intervention. Implications of our data indicated the importance of IPE interventions that include not only classroom-based sessions, but actual patient care experiences within interprofessional teams. It also reinforced the importance of new and unique methods to assess IPE.

Nipple adenoma in a female patient presenting with persistent erythema of the right nipple skin: case report, review of the literature, clinical implications, and relevancy to health care providers who evaluate and treat patients with dermatologic conditions of the breast skin.

PubMed

Spohn, Gina P; Trotter, Shannon C; Tozbikian, Gary; Povoski, Stephen P

2016-05-20

Nipple adenoma is a very uncommon, benign proliferative process of lactiferous ducts of the nipple. Clinically, it often presents as a palpable nipple nodule, a visible nipple skin erosive lesion, and/or with discharge from the surface of the nipple skin, and is primarily seen in middle-aged women. Resultantly, nipple adenoma can clinically mimic the presentation of mammary Paget's disease of the nipple. The purpose of our current case report is to present a comprehensive review of the available data on nipple adenoma, as well as provide useful information to health care providers (including dermatologists, breast health specialists, and other health care providers) who evaluate patients with dermatologic conditions of the breast skin for appropriately clinically recognizing, diagnosing, and treating patients with nipple adenoma. Fifty-three year old Caucasian female presented with a one year history of erythema and induration of the skin of the inferior aspect of the right nipple/areolar region. Skin punch biopsies showed subareolar duct papillomatosis. The patient elected to undergo complete surgical excision with right central breast resection. Final histopathologic evaluation confirmed nipple adenoma. The patient is doing well 31 months after her definitive surgical therapy. Since nipple adenoma represents a benign proliferative process of the nipple, complete surgical excision is curative. However, the coexistence of nipple adenoma and ipsilateral or contralateral breast cancer is well reported in the literature. The potential for a direct causal link or association of nipple adenoma and breast cancer cannot be fully excluded.

Clinical trials involving positron emission tomography and prostate cancer: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Vlaskou Badra, Eugenia; Tsikkinis, Alexandros; Prasad, Vikas; Kroeze, Stephanie; Igrutinovic, Ivan; Jeremic, Branislav; Beck, Marcus; Zschaeck, Sebastian; Wust, Peter; Ghadjar, Pirus

2018-06-18

The goal of this study is to evaluate the status and future perspectives of clinical trials on positron emission tomography in prostate cancer for diagnostic or therapeutic as well as for surveillance purposes. The www.ClinicalTrials.gov database was searched on the 20th of January 2017 for all trials containing terms describing "prostate cancer" (prostate, prostatic, malignant, malignancy, cancer, tumor) and "positron emission tomography". In total 167 trials were identified. Trials that included diseases other than PCa were excluded (n = 27; 16%). Furthermore, we excluded trials (n = 4, 2%) withdrawn prior to first patient enrollment. The remaining trials (n = 137, 82%) were selected for further manual classification analysis. One hundred thirty-seven trials were detected and analyzed. Majority of trials were in "active" recruitment status (n = 46, 34%) followed by trials that had been "completed" - (n = 34, 25%) and trials with "closed recruitment but active follow-up" (n = 23, 17%). Phase 1 and 2 comprised 46% of the complete trial portfolio. Locally confined disease was of major interest (n = 46, 34%), followed by metastatic disease - not otherwise specified (n = 43, 13%). Evaluation of PET was the primary goal of the trial in 114 (83%) cases. Most of the trials evaluated only one agent (n = 122, 89%). Choline and PSMA represented two major groups (total 50%) and they were equally distributed across trial portfolio with 25% (n = 34) each. PSMA trials showed the highest average annual growth rate of 56%. The trials were conducted in 17 countries. The scientific community is showing a strong and ever-growing interest in the field and we expect that in the coming years, more phase III trials will be initiated ultimately delivering the required Level 1 evidence.

Building Capacity for Complementary and Integrative Medicine Through a Large, Cross-Agency, Acupuncture Training Program: Lessons Learned from a Military Health System and Veterans Health Administration Joint Initiative Project.

PubMed

Niemtzow, Richard; Baxter, John; Gallagher, Rollin M; Pock, Arnyce; Calabria, Kathryn; Drake, David; Galloway, Kevin; Walter, Joan; Petri, Richard; Piazza, Thomas; Burns, Stephen; Hofmann, Lew; Biery, John; Buckenmaier, Chester

2018-03-26

Complementary and integrative medicine (CIM) use in the USA continues to expand, including within the Military Health System (MHS) and Veterans Health Administration (VHA). To mitigate the opioid crisis and provide additional non-pharmacological pain management options, a large cross-agency collaborative project sought to develop and implement a systems-wide curriculum, entitled Acupuncture Training Across Clinical Settings (ATACS). ATACS curriculum content and structure were created and refined over the course of the project in response to consultations with Subject Matter Experts and provider feedback. Course content was developed to be applicable to the MHS and VHA environments and training was open to many types of providers. Training included a 4-hr didactic and "hands on" clinical training program focused on a single auricular acupuncture protocol, Battlefield Acupuncture. Trainee learning and skills proficiency were evaluated by trainer-observation and written examination. Immediately following training, providers completed an evaluation survey on their ATACS experience. One month later, they were asked to complete another survey regarding their auricular acupuncture use and barriers to use. The present evaluation describes the ATACS curriculum, faculty and trainee characteristics, as well as trainee and program developer perspectives. Over the course of a 19-mo period, 2,712 providers completed the in-person, 4-hr didactic and hands-on clinical training session. Due to the increasing requests for training, additional ATACS faculty were trained. Overall, 113 providers were approved to be training faculty. Responses from the trainee surveys indicated high satisfaction with the ATACS training program and illuminated several challenges to using auricular acupuncture with patients. The most common reported barrier to using auricular acupuncture was the lack of obtaining privileges to administer auricular acupuncture within clinical practice. The ATACS program provided a foundational template to increase CIM across the MHS and VHA. The lessons learned in the program's implementation will aid future CIM training programs and improve program evaluations. Future work is needed to determine the most efficient means of improving CIM credentialing and privileging procedures, standardizing and adopting uniform CIM EHR codes and documentation, and examining the effectiveness of CIM techniques in real-world settings.

Perceptions of a continuing professional development portfolio model to enhance the scholarship of teaching and learning.

PubMed

Tofade, Toyin; Abate, Marie; Fu, Yunting

2014-04-01

To obtain feedback about the potential usefulness of a continuing professional development (CPD) portfolio for enhancing a faculty or practitioner's scholarship of teaching and learning (SoTL). A CPD portfolio approach to the SoTL was distributed in advance to registrants of the 2011 Annual AACP Teacher's Seminar. In an interactive workshop, faculty facilitators described a model for a CPD process applied to the development of an individual's SoTL. During the workshop, participants were asked to complete the initial sections of the portfolio to develop a personal plan for success in the SoTL. Post workshop, an evaluation form was distributed to the participants to obtain feedback about the CPD approach. Completed evaluation forms were collected, collated, and summarized. A total of 53 (14.1%) workshop participants completed the evaluation form of the 375 attendees. In all, 25 assistant professors, 14 associate professors, 4 full professors, 10 residents/students, 22 clinical, and 2 research faculty submitted evaluations. The proposed uses for the portfolio model selected most often by the responders were for personal development, faculty evaluation, increasing the SoTL, new faculty development, preceptor development, and residency training. A structured CPD portfolio model might be useful for the professional development of the SoTL.

Audit of Orthopaedic Audits in an English Teaching Hospital: Are We Closing the Loop?

PubMed Central

Iqbal, H.J; Pidikiti, P

2010-01-01

Background: Clinical audit is an important tool to improve patient care and outcomes in health service. A significant proportion of time and economic resources are spent on activities related to clinical audit. Completion of audit cycle is essential to confirm the improvements in healthcare delivery. We aimed this study to evaluate audits carried out within trauma and orthopaedic unit of a teaching hospital over the last 4 years, and establish the proportions which were re-audited as per recommendations. Methods: Data was collected from records of the clinical audit department. All orthopaedic audit projects from 2005 to 2009 were included in this study. The projects were divided in to local, regional and national audits. Data regarding audit lead clinicians, completion and presentation of projects, recommendations and re-audits was recorded. Results: Out of 61 audits commenced during last four years, 19.7% (12) were abandoned, 72.1% (44) were presented and 8.2 % (5) were still ongoing. The audit cycle was completed in only 29% (13) projects. Conclusion: Change of junior doctors every 4~6 months is related to fewer re-audits. Active involvement by supervising consultant, reallocation of the project after one trainee has finished, and full support of audit department may increase the ratio of completion of audit cycles, thereby improving the patient care. PMID:20721318

Construction of an efficient evaluative instrument for myasthenia gravis: the MG composite.

PubMed

Burns, Ted M; Conaway, Mark R; Cutter, Gary R; Sanders, Donald B

2008-12-01

We assessed the performance of items from the Quantitative Myasthenia Gravis (QMG), MMT (Manual Muscle Test), and MG-ADL (Myasthenia Gravis - Activities of Daily Living) scales, using data from two recently completed treatment trials of generalized MG. Items were selected that were relevant to manifestations of MG, meaningful to both the physician and the patient, and responsive to clinical change. After the 10 items were chosen, they were weighted based on input from MG experts from around the world, considering factors such as quality of life, disease severity, risk, prognosis, validity, and reliability. The MG Composite is easy to administer, takes less than 5 minutes to complete, and requires no equipment. Weighting of the response options of the 10 items should result in ordinal scores that better represent MG status and are more responsive to meaningful clinical change. To better determine its suitability for clinical use and for treatment trials, the MG Composite will be tested prospectively at several academic medical centers and will be used as a secondary measure of efficacy in pending clinical trials of MG.

Detection of residual disease after neoadjuvant chemoradiotherapy for oesophageal cancer (preSANO): a prospective multicentre, diagnostic cohort study.

PubMed

Noordman, Bo Jan; Spaander, Manon C W; Valkema, Roelf; Wijnhoven, Bas P L; van Berge Henegouwen, Mark I; Shapiro, Joël; Biermann, Katharina; van der Gaast, Ate; van Hillegersberg, Richard; Hulshof, Maarten C C M; Krishnadath, Kausilia K; Lagarde, Sjoerd M; Nieuwenhuijzen, Grard A P; Oostenbrug, Liekele E; Siersema, Peter D; Schoon, Erik J; Sosef, Meindert N; Steyerberg, Ewout W; van Lanschot, J Jan B

2018-05-31

After neoadjuvant chemoradiotherapy for oesophageal cancer, roughly half of the patients with squamous cell carcinoma and a quarter of those with adenocarcinoma have a pathological complete response of the primary tumour before surgery. Thus, the necessity of standard oesophagectomy after neoadjuvant chemoradiotherapy should be reconsidered for patients who respond sufficiently to neoadjuvant treatment. In this study, we aimed to establish the accuracy of detection of residual disease after neoadjuvant chemoradiotherapy with different diagnostic approaches, and the optimal combination of diagnostic techniques for clinical response evaluations. The preSANO trial was a prospective, multicentre, diagnostic cohort study at six centres in the Netherlands. Eligible patients were aged 18 years or older, had histologically proven, resectable, squamous cell carcinoma or adenocarcinoma of the oesophagus or oesophagogastric junction, and were eligible for potential curative therapy with neoadjuvant chemoradiotherapy (five weekly cycles of carboplatin [area under the curve 2 mg/mL per min] plus paclitaxel [50 mg/m 2 of body-surface area] combined with 41·4 Gy radiotherapy in 23 fractions) followed by oesophagectomy. 4-6 weeks after completion of neoadjuvant chemoradiotherapy, patients had oesophagogastroduodenoscopy with biopsies and endoscopic ultrasonography with measurement of maximum tumour thickness. Patients with histologically proven locoregional residual disease or no-pass during endoscopy and without distant metastases underwent immediate surgical resection. In the remaining patients a second clinical response evaluation was done (PET-CT, oesophagogastroduodenoscopy with biopsies, endoscopic ultrasonography with measurement of maximum tumour thickness, and fine-needle aspiration of suspicious lymph nodes), followed by surgery 12-14 weeks after completion of neoadjuvant chemoradiotherapy. The primary endpoint was the correlation between clinical response during clinical response evaluations and the final pathological response in resection specimens, as shown by the proportion of tumour regression grade (TRG) 3 or 4 (>10% residual carcinoma in the resection specimen) residual tumours that was missed during clinical response evaluations. This study was registered with the Netherlands Trial Register (NTR4834), and has been completed. Between July 22, 2013, and Dec 28, 2016, 219 patients were included, 207 of whom were included in the analyses. Eight of 26 TRG3 or TRG4 tumours (31% [95% CI 17-50]) were missed by endoscopy with regular biopsies and fine-needle aspiration. Four of 41 TRG3 or TRG4 tumours (10% [95% CI 4-23]) were missed with bite-on-bite biopsies and fine-needle aspiration. Endoscopic ultrasonography with maximum tumour thickness measurement missed TRG3 or TRG4 residual tumours in 11 of 39 patients (28% [95% CI 17-44]). PET-CT missed six of 41 TRG3 or TRG4 tumours (15% [95% CI 7-28]). PET-CT detected interval distant histologically proven metastases in 18 (9%) of 190 patients (one squamous cell carcinoma, 17 adenocarcinomas). After neoadjuvant chemoradiotherapy for oesophageal cancer, clinical response evaluation with endoscopic ultrasonography, bite-on-bite biopsies, and fine-needle aspiration of suspicious lymph nodes was adequate for detection of locoregional residual disease, with PET-CT for detection of interval metastases. Active surveillance with this combination of diagnostic modalities is now being assessed in a phase 3 randomised controlled trial (SANO trial; Netherlands Trial Register NTR6803). Dutch Cancer Society. Copyright © 2018 Elsevier Ltd. All rights reserved.

Best strategies to implement clinical pathways in an emergency department setting: study protocol for a cluster randomized controlled trial

PubMed Central

2013-01-01

Background The clinical pathway is a tool that operationalizes best evidence recommendations and clinical practice guidelines in an accessible format for ‘point of care’ management by multidisciplinary health teams in hospital settings. While high-quality, expert-developed clinical pathways have many potential benefits, their impact has been limited by variable implementation strategies and suboptimal research designs. Best strategies for implementing pathways into hospital settings remain unknown. This study will seek to develop and comprehensively evaluate best strategies for effective local implementation of externally developed expert clinical pathways. Design/methods We will develop a theory-based and knowledge user-informed intervention strategy to implement two pediatric clinical pathways: asthma and gastroenteritis. Using a balanced incomplete block design, we will randomize 16 community emergency departments to receive the intervention for one clinical pathway and serve as control for the alternate clinical pathway, thus conducting two cluster randomized controlled trials to evaluate this implementation intervention. A minimization procedure will be used to randomize sites. Intervention sites will receive a tailored strategy to support full clinical pathway implementation. We will evaluate implementation strategy effectiveness through measurement of relevant process and clinical outcomes. The primary process outcome will be the presence of an appropriately completed clinical pathway on the chart for relevant patients. Primary clinical outcomes for each clinical pathway include the following: Asthma—the proportion of asthmatic patients treated appropriately with corticosteroids in the emergency department and at discharge; and Gastroenteritis—the proportion of relevant patients appropriately treated with oral rehydration therapy. Data sources include chart audits, administrative databases, environmental scans, and qualitative interviews. We will also conduct an overall process evaluation to assess the implementation strategy and an economic analysis to evaluate implementation costs and benefits. Discussion This study will contribute to the body of evidence supporting effective strategies for clinical pathway implementation, and ultimately reducing the research to practice gaps by operationalizing best evidence care recommendations through effective use of clinical pathways. Trial registration ClinicalTrials.gov: NCT01815710 PMID:23692634

Sentinel Lymph Node Biopsy in Breast Cancer: A Clinical Review and Update

PubMed Central

Haji, Altaf; Battoo, Azhar; Qurieshi, Mariya; Mir, Wahid; Shah, Mudasir

2017-01-01

Sentinel lymph node biopsy has become a standard staging tool in the surgical management of breast cancer. The positive impact of sentinel lymph node biopsy on postoperative negative outcomes in breast cancer patients, without compromising the oncological outcomes, is its major advantage. It has evolved over the last few decades and has proven its utility beyond early breast cancer. Its applicability and efficacy in patients with clinically positive axilla who have had a complete clinical response after neoadjuvant chemotherapy is being aggressively evaluated at present. This article discusses how sentinel lymph node biopsy has evolved and is becoming a useful tool in new clinical scenarios of breast cancer management. PMID:28970846

Sentinel Lymph Node Biopsy in Breast Cancer: A Clinical Review and Update.

PubMed

Zahoor, Sheikh; Haji, Altaf; Battoo, Azhar; Qurieshi, Mariya; Mir, Wahid; Shah, Mudasir

2017-09-01

Sentinel lymph node biopsy has become a standard staging tool in the surgical management of breast cancer. The positive impact of sentinel lymph node biopsy on postoperative negative outcomes in breast cancer patients, without compromising the oncological outcomes, is its major advantage. It has evolved over the last few decades and has proven its utility beyond early breast cancer. Its applicability and efficacy in patients with clinically positive axilla who have had a complete clinical response after neoadjuvant chemotherapy is being aggressively evaluated at present. This article discusses how sentinel lymph node biopsy has evolved and is becoming a useful tool in new clinical scenarios of breast cancer management.

Shoulder arthroscopy simulator training improves shoulder arthroscopy performance in a cadaveric model.

PubMed

Henn, R Frank; Shah, Neel; Warner, Jon J P; Gomoll, Andreas H

2013-06-01

The purpose of this study was to quantify the benefits of shoulder arthroscopy simulator training with a cadaveric model of shoulder arthroscopy. Seventeen first-year medical students with no prior experience in shoulder arthroscopy were enrolled and completed this study. Each subject completed a baseline proctored arthroscopy on a cadaveric shoulder, which included controlling the camera and completing a standard series of tasks using the probe. The subjects were randomized, and 9 of the subjects received training on a virtual reality simulator for shoulder arthroscopy. All subjects then repeated the same cadaveric arthroscopy. The arthroscopic videos were analyzed in a blinded fashion for time to task completion and subjective assessment of technical performance. The 2 groups were compared by use of Student t tests, and change over time within groups was analyzed with paired t tests. There were no observed differences between the 2 groups on the baseline evaluation. The simulator group improved significantly from baseline with respect to time to completion and subjective performance (P < .05). Time to completion was significantly faster in the simulator group compared with controls at the final evaluation (P < .05). No difference was observed between the groups on the subjective scores at the final evaluation (P = .98). Shoulder arthroscopy simulator training resulted in significant benefits in clinical shoulder arthroscopy time to task completion in this cadaveric model. This study provides important additional evidence of the benefit of simulators in orthopaedic surgical training. There may be a role for simulator training in shoulder arthroscopy education. Copyright © 2013 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Improving magnetic resonance imaging (MRI) examinations: Development and evaluation of an intervention to reduce movement in scanners and facilitate scan completion.

PubMed

Powell, Rachael; Ahmad, Mahadir; Gilbert, Fiona J; Brian, David; Johnston, Marie

2015-09-01

The movement of patients in magnetic resonance imaging (MRI) scanners results in motion artefacts which impair image quality. Non-completion of scans leads to delay in diagnosis and increased costs. This study aimed to develop and evaluate an intervention to enable patients to stay still in MRI scanners (reducing motion artefacts) and to enhance scan completion. Successful scan outcome was deemed to be completing the scan with no motion artefacts. Previous research indicated self-efficacy to predict successful scan outcome, and interviews with patients identified a need for procedural and sensory information to facilitate successful scan behaviour. A DVD intervention was developed which targeted self-efficacy and included procedural and sensory information. It was successfully piloted with 10 patients and then evaluated in a randomized controlled trial compared with the standard hospital information leaflet (intervention group N = 41; control group N = 42). The clinic radiographer, who was blind to group allocation, rated MRI scans for motion artefact and recorded whether the participant completed the scan; participants completed MRI self-efficacy and anxiety measures. Only one participant reported not finding the DVD useful. Thirty-five participants in the intervention group and 23 in the control group completed scans and had no motion artefacts, χ(2) (1, 83) = 7.84, p < .001 (relative risk of an unsatisfactory outcome in the control group/intervention group = 3.09). The intervention effect was mediated by self-efficacy. The DVD intervention was efficacious and warrants further research to examine generalizability. © 2015 The British Psychological Society.

Evaluating a Two-Step Approach to Sexual Risk Reduction in a Publicly-Funded STI Clinic

PubMed Central

Carey, Michael P.; Vanable, Peter A.; Senn, Theresa E.; Coury-Doniger, Patricia; Urban, Marguerite A.

2008-01-01

Background Sexually transmitted infection (STI) clinics provide an opportune setting for HIV prevention efforts. This randomized controlled trial evaluated a unique, two-step approach to sexual risk reduction at a publicly-funded STI clinic. Methods During an initial visit, patients completed an audio-computer assisted self-interview (ACASI), were randomized to and received one of two brief interventions, obtained medical care, and completed a post-assessment. Next, two-thirds of the patients were assigned to attend an intensive sexual risk reduction workshop. At 3, 6, and 12 months, patients completed additional ACASIs and provided urine specimens to assess behavior change and incident STIs. Results During a 28-month interval, 5613 patients were screened, 2691 were eligible, and 1483 consented to participate and were randomized; the modal reason for declining was lack of time (82%). Consenting patients included 688 women and 795 men; 64% of participants were African-American. The sample was low-income with 57% reporting an annual income of less than $15,000; most participants (62%) had a high school education or less, and 51% were unemployed. Sexual risk behavior was common, as indicated by multiple sexual partners (mean = 32.8, lifetime; mean = 2.8, past 3 months), unprotected sex (mean = 17.3 episodes, past 3 months), and prior STIs (mean = 3.3, lifetime; 23% at baseline). Bivariate analyses confirmed our prediction that HIV-related motivation and behavioral skills would be related to current sexual risk behavior. All patients received a brief intervention; patient satisfaction ratings were uniformly high for both interventions (all means ≥ 3.7 on 4-point scales). Fifty-six percent of invited patients attended the intensive workshop, and attendance did not differ as a function of brief intervention. Patient satisfaction ratings were also uniformly positive for the workshop interventions (all means ≥ 3.6). Return to follow-up assessments exceeded 70%. Conclusions Results demonstrate that implementing an HIV preventive program in a busy, public clinic is feasible and well-accepted by patients. Ongoing evaluation will determine if the interventions reduce sexual risk behavior and lower incident STIs. PMID:18325853

A call for more transparency of registered clinical trials on endometriosis

PubMed Central

Guo, Sun-Wei; Hummelshoj, Lone; Olive, David L.; Bulun, Serdar E.; D'Hooghe, Thomas M.; Evers, Johannes L.H.

2009-01-01

In response to the pressing need for more efficacious and safer therapeutics for endometriosis, there have been numerous reports in the last decade of positive results from animal and in vitro studies of various compounds as potential therapeutics for endometriosis. A handful of these have undergone phase II/III clinical trials. Since the announcement of the International Committee of Medical Journal Editors that mandated registration as a prerequisite for publication, 57 endometriosis-related clinical trials have been registered at ClinicalTrials.gov, an Internet-based public depository for information on drug studies. Among them, 25 are listed as completed, and 2 as suspended. There are 15 completed phase II/III trials, which evaluated the efficacy of various promising compounds. Yet only three of the 15 trials (20%) have published their results. The remaining 12 (80%) studies so far have not published their findings. We argue that this apparent lack of transparency will actually not benefit the trial sponsors or the public, and will ultimately prove detrimental to research efforts attempting to develop more efficacious and safer therapeutics for endometriosis. Thus we call for more transparency of clinical trials on endometriosis. PMID:19264712

Evaluating the Relationship Between Participation in Student-Run Free Clinics and Changes in Empathy in Medical Students.

PubMed

Modi, Anita; Fascelli, Michele; Daitch, Zachary; Hojat, Mohammadreza

2017-07-01

We explored differences in changes in medical student empathy in the third year of medical school between volunteers at JeffHOPE, a multisite medical student-run free clinic of Sidney Kimmel Medical College (SKMC), and nonvolunteers. Volunteerism and leadership experience at JeffHOPE were documented for medical students in the Class of 2015 (n = 272) across their medical educations. Students completed the Jefferson Scale of Empathy at the beginning of medical school and at the end of the third year. Students who reported participation in other Jefferson-affiliated clinics (n = 44) were excluded from this study. Complete data were available for 188 SKMC students. Forty-five percent of students (n = 85) volunteered at JeffHOPE at least once during their medical educations. Fifteen percent of students (n = 48) were selected for leadership positions involving weekly clinic participation. Nonvolunteers demonstrated significant decline in empathy in medical school ( P = 0.009), while those who volunteered at JeffHOPE at least once over the course of their medical educations did not show any significant decline ( P = 0.07). These findings suggest that medical students may benefit from volunteering at student-run free clinics to care for underserved populations throughout medical school.

Treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated systemic vasculitis with high-dose intravenous immunoglobulin.

PubMed

Richter, C; Schnabel, A; Csernok, E; De Groot, K; Reinhold-Keller, E; Gross, W L

1995-07-01

In this uncontrolled study 15 patients with ANCA-associated systemic vasculitis, who were poor responders to conventional therapy, were treated with single or multiple courses of intravenous immunoglobulin (IVIG), 30 g/day over 5 days. Clinical and serological evaluation was performed before and 4 weeks after IVIG. Six of the 15 patients experienced clinically significant benefit from IVIG. Improvement was confined to single organ manifestations (skin, ENT findings), no improvement was seen with conjunctivitis and scleritis, pericarditis or nephritis. No patient experienced complete remission after IVIG. Repeated courses of IVIG at 4-week intervals were no more effective than single courses. In six anti-proteinase 3 (PR3)-positive patients pretreatment sera were incubated with F(ab')2 fragments of the IVIG preparation in vitro to measure the inhibitory effect of IVIG on anti-PR3 activity. An inhibition of anti-PR3 activity by 25-70% was observed; this did not correlate with clinical effects. Approximately 40% of patients benefited from IVIG treatment, though complete remission of disease activity did not occur. Neither clinical characteristics nor the inhibitory effect of the IVIG preparation on serum anti-PR3 activity in vitro predicted clinical response to this treatment modality.

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

PubMed

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

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

Differentiation between Bulimia and Food Addiction in a Community Sample.

ERIC Educational Resources Information Center

Webbe, Frank M.; Clontz, Joanne

Most studies of bulimics have used an identified, clinical sample of individuals who have been evaluated and diagnosed by professional mental health workers. In this study, self-reported food addicts completed a questionnaire that assessed demographic as well as behavioral and cognitive factors related to their eating. The intent was to describe…

Developmental Regression and Autism Reported to the Vaccine Adverse Event Reporting System

ERIC Educational Resources Information Center

Woo, Emily Jane; Ball, Robert; Landa, Rebecca; Zimmerman, Andrew W.; Braun, M. Miles

2007-01-01

We report demographic and clinical characteristics of children reported to the US Vaccine Adverse Event Reporting System (VAERS) as having autism or another developmental disorder after vaccination. We completed 124 interviews with parents and reviewed medical records for 31 children whose records contained sufficient information to evaluate the…

75 FR 34148 - Intent To Request Renewal From OMB of One Current Public Collection of Information; Office of Law...

Federal Register 2010, 2011, 2012, 2013, 2014

2010-06-16

.../ Federal Air Marshal are required to complete regarding their mental health history. DATES: Send your..., Communications Branch, Business Management Office, Office of Information Technology, TSA-11, Transportation... evaluation determining that they do not have an established medical history or clinical diagnosis of...

Usefulness of a Clinician Rating Scale in Identifying Preschool Children with ADHD

ERIC Educational Resources Information Center

Gopin, Chaya; Healey, Dione; Castelli, Katia; Marks, David; Halperin, Jeffrey M.

2010-01-01

Objective: To ascertain the psychometric properties and clinical utility of the Behavioral Rating Inventory for Children (BRIC), a novel clinician inventory for preschoolers. Method: Completion of the BRIC for 214 preschoolers follows 2 evaluation sessions, generally separated by less than 2 weeks. Items are submitted to a Principal Components…

Using ePortfolio's to Assess Undergraduate Paramedic Students: A Proof of Concept Evaluation

ERIC Educational Resources Information Center

Mason, Rod; Williams, Brett

2016-01-01

The ePortfolio presents itself as potentially a highly useful assessment tool for students, encouraging self-reflection and the development of both clinical skills and theoretical knowledge by students identifying strengths and gaps in knowledge. A survey of students after the completion the inaugural Emergency Health ePortfolio program revealed…

Evaluation of a web-based program promoting healthy eating and physical activity for adolescents: Teen Choice: Food and Fitness

USDA-ARS?s Scientific Manuscript database

This randomized clinical trial tested the impact of a website promoting nutrition and physical activity for adolescents (Teen Choice: Food and Fitness). Participants, 408 12- to 17-year-old adolescents in the Houston area, completed online surveys measuring diet, physical activity, sedentary behavio...

Expressive and Receptive Language Effects of African American English on a Sentence Imitation Task

ERIC Educational Resources Information Center

Terry, J. Michael; Jackson, Sandra C.; Evangelou, Evangelos; Smith, Richard L.

2010-01-01

This study tests the extent to which giving credit for African American English (AAE) responses on a General American English sentence imitation test mitigates dialect effects. Forty-eight AAE-speaking second graders completed the Recalling Sentences subtest of the Clinical Evaluation of Language Fundamentals-Third Edition (1995). A Bayesian…

A Retrospective View of Selective Admission of Physical Therapist Assistants.

ERIC Educational Resources Information Center

Pape, C. Dale; Casey, John P.

1986-01-01

This study was an attempt to evaluate how well a specific selection formula for admission to a physical therapist assistant program worked. It compared the relative selective admission score with the clinical and academic success of those students who completed the course of study; this necessitated a retrospective analysis. (Author/CT)

Consumer participation in quality improvements for chronic disease care: development and evaluation of an interactive patient-centered survey to identify preferred service initiatives.

PubMed

Fradgley, Elizabeth A; Paul, Christine L; Bryant, Jamie; Roos, Ian A; Henskens, Frans A; Paul, David J

2014-12-19

With increasing attention given to the quality of chronic disease care, a measurement approach that empowers consumers to participate in improving quality of care and enables health services to systematically introduce patient-centered initiatives is needed. A Web-based survey with complex adaptive questioning and interactive survey items would allow consumers to easily identify and prioritize detailed service initiatives. The aim was to develop and test a Web-based survey capable of identifying and prioritizing patient-centered initiatives in chronic disease outpatient services. Testing included (1) test-retest reliability, (2) patient-perceived acceptability of the survey content and delivery mode, and (3) average completion time, completion rates, and Flesch-Kincaid reading score. In Phase I, the Web-based Consumer Preferences Survey was developed based on a structured literature review and iterative feedback from expert groups of service providers and consumers. The touchscreen survey contained 23 general initiatives, 110 specific initiatives available through adaptive questioning, and a relative prioritization exercise. In Phase II, a pilot study was conducted within 4 outpatient clinics to evaluate the reliability properties, patient-perceived acceptability, and feasibility of the survey. Eligible participants were approached to complete the survey while waiting for an appointment or receiving intravenous therapy. The age and gender of nonconsenters was estimated to ascertain consent bias. Participants with a subsequent appointment within 14 days were asked to complete the survey for a second time. A total of 741 of 1042 individuals consented to participate (71.11% consent), 529 of 741 completed all survey content (78.9% completion), and 39 of 68 completed the test-retest component. Substantial or moderate reliability (Cohen's kappa>0.4) was reported for 16 of 20 general initiatives with observed percentage agreement ranging from 82.1%-100.0%. The majority of participants indicated the Web-based survey was easy to complete (97.9%, 531/543) and comprehensive (93.1%, 505/543). Participants also reported the interactive relative prioritization exercise was easy to complete (97.0%, 189/195) and helped them to decide which initiatives were of most importance (84.6%, 165/195). Average completion time was 8.54 minutes (SD 3.91) and the Flesch-Kincaid reading level was 6.8. Overall, 84.6% (447/529) of participants indicated a willingness to complete a similar survey again. The Web-based Consumer Preferences Survey is sufficiently reliable and highly acceptable to patients. Based on completion times and reading level, this tool could be integrated in routine clinical practice and allows consumers to easily participate in quality evaluation. Results provide a comprehensive list of patient-prioritized initiatives for patients with major chronic conditions and delivers practice-ready evidence to guide improvements in patient-centered care.

Evaluation of audit-based performance measures for dental care plans.

PubMed

Bader, J D; Shugars, D A; White, B A; Rindal, D B

1999-01-01

Although a set of clinical performance measures, i.e., a report card for dental plans, has been designed for use with administrative data, most plans do not have administrative data systems containing the data needed to calculate the measures. Therefore, we evaluated the use of a set of proxy clinical performance measures calculated from data obtained through chart audits. Chart audits were conducted in seven dental programs--three public health clinics, two dental health maintenance organizations (DHMO), and two preferred provider organizations (PPO). In all instances audits were completed by clinical staff who had been trained using telephone consultation and a self-instructional audit manual. The performance measures were calculated for the seven programs, audit reliability was assessed in four programs, and for one program the audit-based proxy measures were compared to the measures calculated using administrative data. The audit-based measures were sensitive to known differences in program performance. The chart audit procedures yielded reasonably reliable data. However, missing data in patient charts rendered the calculation of some measures problematic--namely, caries and periodontal disease assessment and experience. Agreement between administrative and audit-based measures was good for most, but not all, measures in one program. The audit-based proxy measures represent a complex but feasible approach to the calculation of performance measures for those programs lacking robust administrative data systems. However, until charts contain more complete diagnostic information (i.e., periodontal charting and diagnostic codes or reason-for-treatment codes), accurate determination of these aspects of clinical performance will be difficult.

Using low-cost Android tablets and instructional videos to teach clinical skills to medical students in Kenya: a prospective study

PubMed Central

Ahn, Roy; Nelson, Brett D; Kagan, Calvin; Burke, Thomas F

2016-01-01

Objectives To assess the feasibility and impact of using a low-cost Android tablet to deliver clinical skills training to third-year medical students in Kenya. Design A prospective study using a low cost tablet called ‘connecTAB’, which was designed and manufactured specifically for areas with low bandwidth. Instructional video tutorials demonstrating techniques of cardiovascular and abdominal clinical examinations were pre-loaded onto the tablet. Setting Maseno University School of Medicine, Western Kenya. Participants Fifty-one third-year medical students from Maseno University School of Medicine were subjects in the study. Twenty-five students were assigned to the intervention group and 26 to the control group. Main outcome measures At the start of the study, students from both groups completed an Observed Structured Clinical Examination (OSCE) of the cardiovascular and abdominal evaluations. Students who were allocated to the intervention group then received the connecTAB, whereas students in the control group did not. After a period of three weeks, students from both groups completed a post-study OSCE for both the cardiovascular and abdominal evaluations. Results There were significantly higher improvements in the scores for both cardiovascular and abdominal examinations (p < 0.001) within the group who received the e-tablets as compared to the control group. Conclusion The study suggests that access to connecTAB improves clinical education and efficacy and holds promise for international training in both medical and allied healthcare professional spheres in resource-limited settings. PMID:27540487

Validity of three clinical performance assessments of internal medicine clerks.

PubMed

Hull, A L; Hodder, S; Berger, B; Ginsberg, D; Lindheim, N; Quan, J; Kleinhenz, M E

1995-06-01

To analyze the construct validity of three methods to assess the clinical performances of internal medicine clerks. A multitrait-multimethod (MTMM) study was conducted at the Case Western Reserve University School of Medicine to determine the convergent and divergent validity of a clinical evaluation form (CEF) completed by faculty and residents, an objective structured clinical examination (OSCE), and the medicine subject test of the National Board of Medical Examiners. Three traits were involved in the analysis: clinical skills, knowledge, and personal characteristics. A correlation matrix was computed for 410 third-year students who completed the clerkship between August 1988 and July 1991. There was a significant (p < .01) convergence of the four correlations that assessed the same traits by using different methods. However, the four convergent correlations were of moderate magnitude (ranging from .29 to .47). Divergent validity was assessed by comparing the magnitudes of the convergence correlations with the magnitudes of correlations among unrelated assessments (i.e., different traits by different methods). Seven of nine possible coefficients were smaller than the convergent coefficients, suggesting evidence of divergent validity. A significant CEF method effect was identified. There was convergent validity and some evidence of divergent validity with a significant method effect. The findings were similar for correlations corrected for attenuation. Four conclusions were reached: (1) the reliability of the OSCE must be improved, (2) the CEF ratings must be redesigned to further discriminate among the specific traits assessed, (3) additional methods to assess personal characteristics must be instituted, and (4) several assessment methods should be used to evaluate individual student performances.

Endodontic Management of a Maxillary Lateral Incisor with 4 Root Canals and a Dens Invaginatus Tract.

PubMed

Nosrat, Ali; Schneider, S Craig

2015-07-01

Dens invaginatus (DI) is associated with complex internal anatomy. This article represents a maxillary lateral incisor with 5 root canals including DI. The treatment was planned and performed using cone-beam computed tomographic (CBCT) imaging. After clinical and radiographic evaluations, tooth #7 was diagnosed with DI and pulp necrosis with symptomatic apical periodontitis. Periapical radiographs of the tooth showed 2 roots and complex internal anatomy. CBCT evaluation revealed tooth #7 had 5 separate canals (4 root canals and 1 DI canal extending through the root to the periodontal ligament), communication between DI and the root canal system, and severe and multiple curvatures of the palatal canals. Root canal treatment was completed in 2 visits. Modified access openings were required to safely treat the dilacerated palatal canals. At the 6-month re-evaluation, the patient reported he had remained asymptomatic and his tooth had remained functional since the treatment was completed. Clinical examination showed tooth #7 had no sensitivity to percussion or palpation, probe depths within normal limits (≤3 mm), and no mobility. Radiographic assessment of the tooth showed significant osseous healing of the preoperative lesion. Three-dimensional imaging is a valuable tool for endodontic management of teeth with complex internal anatomy. Three-dimensional imaging is recommended for evaluating and treatment planning cases with DI. Copyright © 2015 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Veterans Health Administration's Disaster Emergency Medical Personnel System (DEMPS) Training Evaluation: Potential Implications for Disaster Health Care Volunteers.

PubMed

Schmitz, Susan; Radcliff, Tiffany A; Chu, Karen; Smith, Robert E; Dobalian, Aram

2018-02-20

The US Veterans Health Administration's Disaster Emergency Medical Personnel System (DEMPS) is a team of employee disaster response volunteers who provide clinical and non-clinical staffing assistance when local systems are overwhelmed. This study evaluated attitudes and recommendations of the DEMPS program to understand the impact of multi-modal training on volunteer perceptions. DEMPS volunteers completed an electronic survey in 2012 (n=2120). Three training modes were evaluated: online, field exercise, and face-to-face. Measures included: "Training Satisfaction," "Attitudes about Training," "Continued Engagement in DEMPS." Data were analyzed using χ2 and logistic regression. Open-ended questions were evaluated in a manner consistent with grounded theory methodology. Most respondents participated in DEMPS training (80%). Volunteers with multi-modal training who completed all 3 modes (14%) were significantly more likely to have positive attitudes about training, plan to continue as volunteers, and would recommend DEMPS to others (P-value<0.001). Some respondents requested additional interactive activities and suggested increased availability of training may improve volunteer engagement. A blended learning environment using multi-modal training methods, could enhance satisfaction and attitudes and possibly encourage continued engagement in DEMPS or similar programs. DEMPS training program modifications in 2015 expanded this blended learning approach through new interactive online learning opportunities. (Disaster Med Public Health Preparedness. 2018; page 1 of 8).

Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods

PubMed Central

Wiljer, David; Cafazzo, Joseph A

2016-01-01

Background Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Objective Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. Methods We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Results Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data collection points: F4,56=3.2, P=.021, η2=0.18. Single-blinded trials had a longer data collection period compared to open trials: F2,58=3.8, P=.028, η2=0.12. Academic sponsorship was the most common form of trial funding (73%, 52/71). Trials with academic sponsorship had a longer study duration compared to industry sponsorship: F2,61=3.7, P=.030, η2=0.11. Combined, data collection frequency, study masking, sample size, and study sponsorship accounted for 32.6% of the variance in study duration: F4,55=6.6, P<.01, adjusted r2=.33. Only 7 trials had been completed at the time this retrospective review was conducted (10%, 7/71). Conclusions mHealth evaluation methodology has not deviated from common methods, despite the need for more relevant and timely evaluations. There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers, providers, policy makers, and patients. PMID:27613084

Beyond the Randomized Controlled Trial: A Review of Alternatives in mHealth Clinical Trial Methods.

PubMed

Pham, Quynh; Wiljer, David; Cafazzo, Joseph A

2016-09-09

Randomized controlled trials (RCTs) have long been considered the primary research study design capable of eliciting causal relationships between health interventions and consequent outcomes. However, with a prolonged duration from recruitment to publication, high-cost trial implementation, and a rigid trial protocol, RCTs are perceived as an impractical evaluation methodology for most mHealth apps. Given the recent development of alternative evaluation methodologies and tools to automate mHealth research, we sought to determine the breadth of these methods and the extent that they were being used in clinical trials. We conducted a review of the ClinicalTrials.gov registry to identify and examine current clinical trials involving mHealth apps and retrieved relevant trials registered between November 2014 and November 2015. Of the 137 trials identified, 71 were found to meet inclusion criteria. The majority used a randomized controlled trial design (80%, 57/71). Study designs included 36 two-group pretest-posttest control group comparisons (51%, 36/71), 16 posttest-only control group comparisons (23%, 16/71), 7 one-group pretest-posttest designs (10%, 7/71), 2 one-shot case study designs (3%, 2/71), and 2 static-group comparisons (3%, 2/71). A total of 17 trials included a qualitative component to their methodology (24%, 17/71). Complete trial data collection required 20 months on average to complete (mean 21, SD 12). For trials with a total duration of 2 years or more (31%, 22/71), the average time from recruitment to complete data collection (mean 35 months, SD 10) was 2 years longer than the average time required to collect primary data (mean 11, SD 8). Trials had a moderate sample size of 112 participants. Two trials were conducted online (3%, 2/71) and 7 trials collected data continuously (10%, 7/68). Onsite study implementation was heavily favored (97%, 69/71). Trials with four data collection points had a longer study duration than trials with two data collection points: F4,56=3.2, P=.021, η(2)=0.18. Single-blinded trials had a longer data collection period compared to open trials: F2,58=3.8, P=.028, η(2)=0.12. Academic sponsorship was the most common form of trial funding (73%, 52/71). Trials with academic sponsorship had a longer study duration compared to industry sponsorship: F2,61=3.7, P=.030, η(2)=0.11. Combined, data collection frequency, study masking, sample size, and study sponsorship accounted for 32.6% of the variance in study duration: F4,55=6.6, P<.01, adjusted r(2)=.33. Only 7 trials had been completed at the time this retrospective review was conducted (10%, 7/71). mHealth evaluation methodology has not deviated from common methods, despite the need for more relevant and timely evaluations. There is a need for clinical evaluation to keep pace with the level of innovation of mHealth if it is to have meaningful impact in informing payers, providers, policy makers, and patients.

Vestibular function outcomes after vestibular neurectomy in Meniere disease: can vestibular neurectomy provide complete vestibular deafferentation?

PubMed

Leveque, M; Seidermann, L; Tran, H; Langagne, T; Ulmer, E; Chays, A

2010-06-01

Vestibular neurectomy is considered the reference treatment of incapacitating vertigo accompanying Meniere disease, with an efficiency rate of 85-95% in most literature reports. The aim of this study is to evaluate if vestibular neurectomy can provide a complete vestibular deafferentation by investigating complete vestibular function after surgery. Prospective study. Twenty-four patients suffering from incapacitated Meniere vertigo crisis beneficiated from a vestibular neurectomy by retrosigmoid approach. The average time between surgery and vestibular evaluation was 1 year. We performed (i) kinetic test, (ii) caloric test and (iii) vibration-induced nystagmus (VIN) at 30, 60 and 100Hz under videonystagmography recording, (iv) vestibular evoked myogenic potentials (VEMP), (v) video head impulsed test (VHIT) for each semicircular canals and (vi) an evaluation of visual vertical and horizontal subjective (VVS and HVS). On clinical evaluation, all the patients except one had never experienced any recurrence of vertigo crisis after surgery. The 24 patients would definitely undergo the surgery again. On vestibular evaluation, on the operated side, all patients showed a total areflexia at caloric test; 23 patients had no VEMP response; 23 patients had abolished canals response to VHIT. All the patients had VVS and HVS deviated towards the operated side; 23 patients had a high velocity VIN from 30 to 60Hz. This study proves that vestibular neurectomy can provide a complete vestibular deafferentation. We discuss this vestibular evaluation protocol and the main difficulties encounter during surgery, which could lead to partial nerve section and partial relief, and explain residual vestibular function after vestibular neurectomy. Copyright (c) 2009 Elsevier Ireland Ltd. All rights reserved.

Development, implementation and evaluation of a terminal and hospice care educational online module for preclinical students.

PubMed

Tse, Chung Sang; Ellman, Matthew S

2017-03-01

To explore the application of an online learning tool to teach preclinical medical students terminal and hospice care in a blended curricula. We created and evaluated a 30 min interactive online module at the Yale School of Medicine. Second-year medical students were randomly assigned to complete the online module or not (control group) prior to attending a required half-day hospice clinical experience. We assessed the students' knowledge and attitudes with a 23-item survey. 152 students (response rate 51%) participated in this study from 2012 to 2014. 56% (n=85) completed the online module, 37% (n=56) did not and 7% (n=11) did not indicate whether they had completed the module or not. Students who completed the online module prior to the hospice experience scored higher (p<0.05, two-way analysis of variance) on 5 out of 8 of the multiple choice questions pertaining to hospice and palliative care, but their attitudes were similar to those who did not complete the online module. Overall, the students felt somewhat uncomfortable caring for dying patients although they regarded it as a physician's duty and felt that palliative/hospice care education is important in medical school. When combined with a mentored clinical hospice experience, an online module appears to enhance the teaching of the dying process and terminal care for preclinical medical students. This online module may prove useful for other institutions. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background Screening can reduce colorectal cancer (CRC) incidence and mortality. However, screening is underutilized in vulnerable patient populations, particularly among Latinos. Patient-directed decision aids can increase CRC screening knowledge, self-efficacy, and intent; however, their effect on actual screening test completion tends to be modest. This is probably because decision aids do not address some of the patient-specific barriers that prevent successful completion of CRC screening in these populations. These individual barriers might be addressed though patient navigation interventions. This study will test a combined decision aid and patient navigator intervention on screening completion in diverse populations of vulnerable primary care patients. Methods/Design We will conduct a multisite, randomized controlled trial with patient-level randomization. Planned enrollment is 300 patients aged 50 to 75 years at average CRC risk presenting for appointments at two primary clinics in North Carolina and New Mexico. Intervention participants will view a video decision aid immediately before the clinic visit. The 14 to 16 minute video presents information about fecal occult blood tests and colonoscopy and will be viewed on a portable computer tablet in English or Spanish. Clinic-based patient navigators are bilingual and bicultural and will provide both face-to-face and telephone-based navigation. Control participants will view an unrelated food safety video and receive usual care. The primary outcome is completion of a CRC screening test at six months. Planned subgroup analyses include examining intervention effectiveness in Latinos, who will be oversampled. Secondarily, the trial will evaluate the intervention effects on knowledge of CRC screening, self-efficacy, intent, and patient-provider communication. The study will also examine whether patient ethnicity, acculturation, language preference, or health insurance status moderate the intervention effect on CRC screening. Discussion This pragmatic randomized controlled trial will test a combined decision aid and patient navigator intervention targeting CRC screening completion. Findings from this trial may inform future interventions and implementation policies designed to promote CRC screening in vulnerable patient populations and to reduce screening disparities. Clinical trial registration ClinicalTrials.gov NCT02054598. PMID:25004983

Breast cancer follow-up and management after primary treatment: American Society of Clinical Oncology clinical practice guideline update.

PubMed

Khatcheressian, James L; Hurley, Patricia; Bantug, Elissa; Esserman, Laura J; Grunfeld, Eva; Halberg, Francine; Hantel, Alexander; Henry, N Lynn; Muss, Hyman B; Smith, Thomas J; Vogel, Victor G; Wolff, Antonio C; Somerfield, Mark R; Davidson, Nancy E

2013-03-01

To provide recommendations on the follow-up and management of patients with breast cancer who have completed primary therapy with curative intent. To update the 2006 guideline of the American Society of Clinical Oncology (ASCO), a systematic review of the literature published from March 2006 through March 2012 was completed using MEDLINE and the Cochrane Collaboration Library. An Update Committee reviewed the evidence to determine whether the recommendations were in need of updating. There were 14 new publications that met inclusion criteria: nine systematic reviews (three included meta-analyses) and five randomized controlled trials. After its review and analysis of the evidence, the Update Committee concluded that no revisions to the existing ASCO recommendations were warranted. Regular history, physical examination, and mammography are recommended for breast cancer follow-up. Physical examinations should be performed every 3 to 6 months for the first 3 years, every 6 to 12 months for years 4 and 5, and annually thereafter. For women who have undergone breast-conserving surgery, a post-treatment mammogram should be obtained 1 year after the initial mammogram and at least 6 months after completion of radiation therapy. Thereafter, unless otherwise indicated, a yearly mammographic evaluation should be performed. The use of complete blood counts, chemistry panels, bone scans, chest radiographs, liver ultrasounds, pelvic ultrasounds, computed tomography scans, [(18)F]fluorodeoxyglucose-positron emission tomography scans, magnetic resonance imaging, and/or tumor markers (carcinoembryonic antigen, CA 15-3, and CA 27.29) is not recommended for routine follow-up in an otherwise asymptomatic patient with no specific findings on clinical examination.

Clinical responses to focused ultrasound applied to women with vulval intraepithelial neoplasia.

PubMed

Jia, Ying; Wu, Jin; Xu, Man; Tang, Liangdan; Li, Chengzhi; Luo, Ming; Lou, Meng

2014-11-01

Focused ultrasound waves penetrate superficial tissues and are aimed toward the target tissues at specific depths to exert their biological effects. Focused ultrasound has been applied for a number of clinical indications, including vulval dystrophies and low-grade vulval disease. This study aimed to assess the efficacy and safety of focused ultrasound treatment of high-grade vulval intraepithelial neoplasia (VIN). Eighteen women with high-grade VIN were recruited and treated with focused ultrasound. During each posttreatment follow-up, the safety of, side effects of, and clinical responses to focused ultrasound were evaluated by a standardized protocol, including symptoms, clinical appearance, and histologic findings. All patients completed the designed follow-ups. In most cases, superficial mild to moderate swelling and blisters were seen in the focused ultrasound-treated skin but not in adjacent normal skin. Of the 18 patients, 16 showed complete histologic regression and resolution of symptoms 6 months after treatment. Of the other 2 patients, 1 showed complete regression after a second focused ultrasound treatment. The other patient did not respond to the focused ultrasound treatment and underwent a partial vulvectomy 6 months after treatment. None of the patients developed invasive carcinoma of the vulva during the follow-up period. One patient had local pruritus that was not alleviated by anti-inflammatory medication and local care. The complete responses observed in women with high-grade VIN treated by focused ultrasound, together with the preservation of adjacent normal tissue, suggest that focused ultrasound may be considered for treatment of high-grade VIN. © 2014 by the American Institute of Ultrasound in Medicine.

Assessment of Clinical Teachers' Professionalism in Iran: From Residents and Fellowships' Perspective.

PubMed

Garshasbi, Sima; Bahador, Hamidollah; Fakhraei, Nahid; Farbod, Abolfazl; Mohammadi, Maryam; Ahmady, Soleiman; Emami Razavi, Seyed Hassan

2017-01-01

In the present study, professional conduct of clinical teachers in Tehran University of Medical Sciences in Iran was assessed by their residents (n=292) and fellowships (n=48) using a standard questioner called self-reported measurement equipment. This evaluation was a descriptive cross-sectional study. Professionalism was questioned in four domains including clinical teacher-patient, clinical teacher-student, inter-professional and clinical teacher-self relationships. Accordingly, mean scores of the teachers in cases of clinical teacher-patient; clinical teacher-student, inter-professional (teamwork) and clinical teacher-self relations were 61%, 62.2%, 60.6% and 57.6%, respectively. Generally, the teachers achieved 60.35% of the positive scores, and as a result, they were assessed intermediate in the professional behaviors. The residents and fellowships stated that they were not completely satisfied with their teacher's professional conduct and had hidden concerns. It shows that the clinical teachers in our project may not be ideal role models. As a result, developing a comprehensive professionalism and implementing regulations to ensure a successful professionalism are necessary. The precise evaluation of professional conduct in clinical faculty could encourage the maintenance of professional behaviors and potentially decrease negative role modeling and positively influence the hidden curriculums. Operational approaches to formulating regulations and appropriate measures for establishing professional ethics are of great importance.

A laboratory medicine residency training program that includes clinical consultation and research.

PubMed

Spitzer, E D; Pierce, G F; McDonald, J M

1990-04-01

We describe a laboratory medicine residency training program that includes ongoing interaction with both clinical laboratories and clinical services as well as significant research experience. Laboratory medicine residents serve as on-call consultants in the interpretation of test results, design of testing strategies, and assurance of test quality. The consultative on-call beeper system was evaluated and is presented as an effective method of clinical pathology training that is well accepted by the clinical staff. The research component of the residency program is also described. Together, these components provide training in real-time clinical problem solving and prepare residents for the changing technological environment of the clinical laboratory. At the completion of the residency, the majority of the residents are qualified laboratory subspecialists and are also capable of running an independent research program.

Transaction cost analysis of in-clinic versus telehealth consultations for chronic pain: preliminary evidence for rapid and affordable access to interdisciplinary collaborative consultation.

PubMed

Theodore, Brian R; Whittington, Jan; Towle, Cara; Tauben, David J; Endicott-Popovsky, Barbara; Cahana, Alex; Doorenbos, Ardith Z

2015-06-01

With ever increasing mandates to reduce costs and increase the quality of pain management, health care institutions are faced with the challenge of adopting innovative technologies and shifting workflows to provide value-based care. Transaction cost economic analysis can provide comparative evaluation of the consequences of these changes in the delivery of care. The aim of this study was to establish proof-of-concept using transaction cost analysis to examine chronic pain management in-clinic and through telehealth. Participating health care providers were asked to identify and describe two comparable completed transactions for patients with chronic pain: one consultation between patient and specialist in-clinic and the other a telehealth presentation of a patient's case by the primary care provider to a team of pain medicine specialists. Each provider completed two on-site interviews. Focus was on the time, value of time, and labor costs per transaction. Number of steps, time, and costs for providers and patients were identified. Forty-six discrete steps were taken for the in-clinic transaction, and 27 steps were taken for the telehealth transaction. Although similar in costs per patient ($332.89 in-clinic vs. $376.48 telehealth), the costs accrued over 153 business days in-clinic and 4 business days for telehealth. Time elapsed between referral and completion of initial consultation was 72 days in-clinic, 4 days for telehealth. U.S. health care is moving toward the use of more technologies and practices, and the information provided by transaction cost analyses of care delivery for pain management will be important to determine actual cost savings and benefits. Wiley Periodicals, Inc.

Transaction Cost Analysis of In-Clinic Versus Telehealth Consultations for Chronic Pain: Preliminary Evidence for Rapid and Affordable Access to Interdisciplinary Collaborative Consultation

PubMed Central

Theodore, Brian R.; Whittington, Jan; Towle, Cara; Tauben, David J.; Endicott-Popovsky, Barbara; Cahana, Alex; Doorenbos, Ardith Z.

2015-01-01

Objectives With ever increasing mandates to reduce costs and increase the quality of pain management, health care institutions are faced with the challenge of adopting innovative technologies and shifting workflows to provide value-based care. Transaction cost economic analysis can provide comparative evaluation of the consequences of these changes in the delivery of care. The aim of this study was to establish proof-of-concept using transaction cost analysis to examine chronic pain management in-clinic and through telehealth. Methods Participating health care providers were asked to identify and describe two comparable completed transactions for patients with chronic pain: one consultation between patient and specialist in-clinic and the other a telehealth presentation of a patient’s case by the primary care provider to a team of pain medicine specialists. Each provider completed two on-site interviews. Focus was on the time, value of time, and labor costs per transaction. Number of steps, time, and costs for providers and patients were identified. Results Forty-six discrete steps were taken for the in-clinic transaction, and 27 steps were taken for the telehealth transaction. Although similar in costs per patient ($332.89 in-clinic vs. $376.48 telehealth), the costs accrued over 153 business days in-clinic and 4 business days for telehealth. Time elapsed between referral and completion of initial consultation was 72 days in-clinic, 4 days for telehealth. Conclusions U.S. health care is moving toward the use of more technologies and practices, and the information provided by transaction cost analyses of care delivery for pain management will be important to determine actual cost savings and benefits. PMID:25616057

A Learner-Centered Technique and Clinical Reasoning, Reflection, and Case Presentation Attributes in Athletic Training Students

PubMed Central

Heinerichs, Scott; Vela, Luzita I.; Drouin, Joshua M.

2013-01-01

Context: Providing opportunities to develop clinical decision-making skills, including clinical reasoning, is an important aspect of clinical education. The learner-centered technique of summarizing the history and findings, narrowing the differential, analyzing the differential, probing the instructor about uncertainties, plan management, and selecting an issue for self-directed study (SNAPPS) is used in medicine to express clinical reasoning. Objective: To investigate the effects of SNAPPS on the clinical reasoning, reflection, and 4 case presentation attributes (length, conciseness, case summary, and expression of clinical reasoning) in athletic training students. Design: Randomized controlled clinical trial. Setting: Three undergraduate programs accredited by the Commission on Accreditation of Athletic Training Education. Patients or Other Participants: We randomly assigned 38 athletic training students (17 men, 21 women; age = 21.53 ± 1.18 years, grade point average = 3.25 ± 0.31) who had completed at least 1 year of clinical education and all orthopaedic evaluation coursework to the SNAPPS group or the usual and customary group using a stratification scheme. Intervention(s): The SNAPPS group completed four 45-minute clinical reasoning and case presentation learning modules led by an investigator to learn the SNAPPS technique, whereas the usual and customary group received no formal instruction. Both groups audio recorded all injury evaluations performed over a 2-week period. Main Outcome Measures: Participants completed the Diagnostic Thinking Inventory and Reflection in Learning Scale twice. Case presentations were analyzed for 4 attributes: length, conciseness, case summary, and expression of clinical reasoning. Results: Case presentations were longer (t18.806 = −5.862, P < .001) but were more concise (t32 = 11.297, P < .001) for the SNAPPS group than for the usual and customary group. The SNAPPS group performed better on both the case summary subscale (t32 = 2.857, P = .007) and the clinical reasoning subscale (t25.773 = −14.162, P < .001) than the other group. We found a time effect for Diagnostic Thinking Inventory scores (F1,34 = 6.230, P = .02) but observed no group effects (F1,34 = 0.698, P = .41) or time-by-group interaction (F1,34 = 1.050, P = .31). The Reflection in Learning Scale scores analysis revealed no group-by-time interaction (F1,34 = 1.470, P = .23) and no group (F1,34 = 3.751, P = .06) or time (F1,34 = 0.835, P = .37) effects. Conclusions: The SNAPPS is an effective and feasible clinical education technique for case presentations. This learner-centered technique provides the opportunity for the expression of clinical reasoning skills. PMID:23675796

A core competency-based objective structured clinical examination (OSCE) can predict future resident performance.

PubMed

Wallenstein, Joshua; Heron, Sheryl; Santen, Sally; Shayne, Philip; Ander, Douglas

2010-10-01

This study evaluated the ability of an objective structured clinical examination (OSCE) administered in the first month of residency to predict future resident performance in the Accreditation Council for Graduate Medical Education (ACGME) core competencies. Eighteen Postgraduate Year 1 (PGY-1) residents completed a five-station OSCE in the first month of postgraduate training. Performance was graded in each of the ACGME core competencies. At the end of 18 months of training, faculty evaluations of resident performance in the emergency department (ED) were used to calculate a cumulative clinical evaluation score for each core competency. The correlations between OSCE scores and clinical evaluation scores at 18 months were assessed on an overall level and in each core competency. There was a statistically significant correlation between overall OSCE scores and overall clinical evaluation scores (R = 0.48, p < 0.05) and in the individual competencies of patient care (R = 0.49, p < 0.05), medical knowledge (R = 0.59, p < 0.05), and practice-based learning (R = 0.49, p < 0.05). No correlation was noted in the systems-based practice, interpersonal and communication skills, or professionalism competencies. An early-residency OSCE has the ability to predict future postgraduate performance on a global level and in specific core competencies. Used appropriately, such information can be a valuable tool for program directors in monitoring residents' progress and providing more tailored guidance. © 2010 by the Society for Academic Emergency Medicine.

Nurse education regarding agitated patients and its effects on clinical practice.

PubMed

Ozdemir, Leyla; Karabulut, Erdem

This study identified the impact of an education program on nurses' practices for agitated patients and documented the changes in practice after completion of the training. Eighteen cardiac intensive care nurses were included to the study. Prior to nurses' participation in an education program, a pre-test indicating nurses' current practices for 40 agitated patients was evaluated with the 'Nurse Practice Form'. After the pre-test data collection period was completed, the 2-day training program on caring for agitated patients was conducted. The last step of the study was evaluation of post-test nurses' practices for 40 agitated patients using the 'Nurse Practice Form'. The findings indicated that instead of pre-test nurses' use of physical restraints for controlling agitated patients without a physician order, none of post-test nurses applied them. The training program provided nurses the knowledge and skills needed to evaluate and to manage the causes of agitation.

Safety of famciclovir in patients with herpes zoster and genital herpes.

PubMed Central

Saltzman, R; Jurewicz, R; Boon, R

1994-01-01

Safety reporting from individual ongoing and completed clinical studies has demonstrated that famciclovir, the well-absorbed oral form of the antiherpesvirus agent penciclovir, has been well tolerated by more than 3,000 individuals worldwide. An integrated safety evaluation has been performed and includes over 1,600 patients from 11 completed, randomized, double-blind clinical trials and 2 open trials. The famciclovir population consisted of 816 herpes zoster patients (four trials), 409 patients with acute genital herpesvirus infections (seven trials), and 382 patients from two genital herpes suppression studies. Overall, the famciclovir-treated patient population was 57.7% female and ranged in age from 15 to 102 years (mean, 42.6 years), with 31.2% aged 50 years or more and 15.7% aged 65 years or more. The mean duration of exposure to famciclovir was 28.8 days (5.8 days excluding suppression studies). The total daily doses ranged from 125 mg to 2.25 g. The most common adverse experiences reported as related to study medication (famciclovir and placebo) were headache, nausea, and diarrhea. The frequencies of adverse experiences and laboratory abnormalities (hematology, clinical chemistry, and urinalysis parameters) were similar in both famciclovir and placebo recipients. Thus, safety data from the analysis of 13 completed clinical studies demonstrate that famciclovir is tolerated well by patients with either herpes zoster or genital and has a safety profile comparable to that of placebo. PMID:7840587

Complementary and alternative medicine use in a pediatric neurology clinic.

PubMed

Aburahma, Samah K; Khader, Yousef S; Alzoubi, Karem; Sawalha, Noor

2010-08-01

To evaluate the frequency and determinants of complementary and alternative medicine (CAM) use in children attending a pediatric neurology clinic in North Jordan, a parent completed questionnaire survey of children attending the pediatric neurology clinic at King Abdullah University Hospital from March to July 2008 was conducted. A review of 176 completed questionnaires showed that 99 parents (56%) had used CAM for their child's specific neurological illness. The most common modalities were prayer/reciting the Quran (77%), religious healers (30%), massage with olive oil (32%), and consumption of honey products (29%). The most common reason was religious beliefs in 68%. None reported lack of trust in conventional medicine as the reason behind seeking CAM. Factors significantly associated with CAM use were speech delay, belief in its usefulness, father's age more than 30 years, and mothers with education less than high school. CAM had a supplementary role in relation to traditional western medicine use. Copyright 2010 Elsevier Ltd. All rights reserved.

Presumed primary thiamine deficiency in a young African lion (Panthera leo).

PubMed

DiGesualdo, Cynthia L; Hoover, John P; Lorenz, Michael D

2005-09-01

A 1-yr-old intact male African lion (Panthera leo) fed only beef muscle meat was evaluated for episodes of hypermetric ataxia, generalized weakness and tonic-clonic front limb movements. A hemogram, biochemical profile, blood lead, electrocardiogram, survey radiographs, and brain computed tomography were normal. Cerebral spinal fluid analyses suggested mild inflammation. Acetylcholine receptor antibody and serologic tests for all infectious agents tested were negative. Clinical signs resolved completely 9 days after instituting oral thiamine (3 mg/kg/day) and a completely nutritional diet. This lion's pretreatment thiamine blood value (11 nmol/L) was markedly lower than that of a healthy lion (191 nmol/L) and a proposed reference range for adult African lions (160-350 nmol/L). The lion remained clinically normal 2 yr later when his blood thiamine value was 340 nmol/L. African lions can develop clinical primary thiamine deficiency and may respond favorably when thiamine treatment and adequate diet are instituted prior to irreversible neuronal necrosis.

A pilot study on the evaluation of medical student documentation: assessment of SOAP notes.

PubMed

Seo, Ji-Hyun; Kong, Hyun-Hee; Im, Sun-Ju; Roh, HyeRin; Kim, Do-Kyong; Bae, Hwa-Ok; Oh, Young-Rim

2016-06-01

The purpose of this study was evaluation of the current status of medical students' documentation of patient medical records. We checked the completeness, appropriateness, and accuracy of 95 Subjective-Objective-Assessment-Plan (SOAP) notes documented by third-year medical students who participated in clinical skill tests on December 1, 2014. Students were required to complete the SOAP note within 15 minutes of an standard patient (SP)-encounter with a SP complaining rhinorrhea and warring about meningitis. Of the 95 SOAP notes reviewed, 36.8% were not signed. Only 27.4% documented the patient's symptoms under the Objective component, although all students completed the Subjective notes appropriately. A possible diagnosis was assessed by 94.7% students. Plans were described in 94.7% of the SOAP notes. Over half the students planned workups (56.7%) for diagnosis and treatment (52.6%). Accurate documentation of the symptoms, physical findings, diagnoses, and plans were provided in 78.9%, 9.5%, 62.1%, and 38.0% notes, respectively. Our results showed that third-year medical students' SOAP notes were not complete, appropriate, or accurate. The most significant problems with completeness were the omission of students' signatures, and inappropriate documentation of the physical examinations conducted. An education and assessment program for complete and accurate medical recording has to be developed.

Implementation of a cloud-based electronic medical record for maternal and child health in rural Kenya.

PubMed

Haskew, John; Rø, Gunnar; Saito, Kaori; Turner, Kenrick; Odhiambo, George; Wamae, Annah; Sharif, Shahnaaz; Sugishita, Tomohiko

2015-05-01

Complete and timely health information is essential to inform public health decision-making for maternal and child health, but is often lacking in resource-constrained settings. Electronic medical record (EMR) systems are increasingly being adopted to support the delivery of health care, and are particularly amenable to maternal and child health services. An EMR system could enable the mother and child to be tracked and monitored throughout maternity shared care, improve quality and completeness of data collected and enhance sharing of health information between outpatient clinic and the hospital, and between clinical and public health services to inform decision-making. This study implemented a novel cloud-based electronic medical record system in a maternal and child health outpatient setting in Western Kenya between April and June 2013 and evaluated its impact on improving completeness of data collected by clinical and public health services. The impact of the system was assessed using a two-sample test of proportions pre- and post-implementation of EMR-based data verification. Significant improvements in completeness of the antenatal record were recorded through implementation of EMR-based data verification. A difference of 42.9% in missing data (including screening for hypertension, tuberculosis, malaria, HIV status or ART status of HIV positive women) was recorded pre- and post-implementation. Despite significant impact of EMR-based data verification on data completeness, overall screening rates in antenatal care were low. This study has shown that EMR-based data verification can improve the completeness of data collected in the patient record for maternal and child health. A number of issues, including data management and patient confidentiality, must be considered but significant improvements in data quality are recorded through implementation of this EMR model. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Assessing obstetric patient experience: a SERVQUAL questionnaire.

PubMed

Garrard, Francesca; Narayan, Harini

2013-01-01

Across health services, there is a drive to respond to patient feedback and to incorporate their views into service improvement. The SERVQUAL method has been used in several clinical settings to quantify whether services meet patient expectations. However, work has been limited in the obstetric population. This paper seeks to address these issues. This study used an adapted SERVQUAL questionnaire to assess a reconfigured antenatal clinic service. The most important care aspects, as rated by patients, were used to construct the SERVQUAL questions. The questionnaire was administered to eligible women in two parts. The first was completed before their first hospital antenatal appointment and the second either at home (a postal-chasing exercise) or while waiting for their next appointment. Only fully completed questionnaires (both parts) were analysed. Service strengths included staff politeness, patient respect and privacy. Areas for improvement included hand cleanliness, women's involvement in decision making and communicating risk. However, the low variability in patient responses makes concrete conclusions difficult and methodological issues complicate evaluating hand cleanliness. The new antenatal clinic service received low negative weighted and un-weighted overall scores. The SERVQUAL measure was developed from patient feedback and used to further improve services. The SERVQUAL-based measure allowed an internal evaluation of patient experience and highlighted areas for improvement. However, without validation, the questionnaire cannot be used as an outcome measure and variation between published SERVQUAL questionnaires makes comparisons difficult. This highlights an important balance in patient evaluation measures--between locally responsive and externally comparable. The SERVQUAL approach allows healthcare teams to evaluate patient experience, while accounting for variation in their expectations and priorities. The study highlights several areas that are important to obstetric patients, where expectation scores are high. However, the similar means and small samples left little difference between excellence and room for improvement.

Determinants and effects of medical students’ core self-evaluation tendencies on clinical competence and workplace well-being in clerkship

PubMed Central

Lin, Yung Kai

2017-01-01

Core self-evaluation (CSE) is a personality trait that involves a person’s evaluation of his or her own worth, competence, and capability. The objective of this study was to determine whether medical students’ CSEs exert beneficial effects on their adaptation to their clerkship in terms of their clinical competence and workplace well-being and whether their preclinical academic performance can be a trait-relevant situation that enhances their CSE expression. In total, 127 medical students from 2 cohorts were included as participants in this study. We analyzed complete measures of personal background, objective and subjective preclinical academic performance (course evaluation grades and self-reported efficacy), CSE tendencies, and clinical competence (as objective structured clinical examination scores) and workplace well-being (as compassion satisfaction and burnout) during their 2-year clerkship. Mixed linear models for repeated measures and multiple regressions were employed. Participants’ CSE tendencies had positive effects on their workplace compassion satisfaction and burnout but not on their clinical competence during their clerkship. Additionally, using the objective and subjective preclinical academic performance of the medical students as indicators, we observed that neither could be trait-relevant situations to enhance their CSE expression. CSE personality tendencies might be key to medical students’ ability to noncognitively adapt to clinical training during their clerkships. These tendencies should be identified earlier so that mentors can provide prompt care and support to mentees (medical students) during clerkships. PMID:29186158

A comparison of dentifrices for clinical relief from dentin hypersensitivity using the Jay Sensitivity Sensor Probe.

PubMed

Hegde, Shashikanth; Rao, B H Sripathi; Kakar, Ravish Chander; Kakar, Ashish

2013-05-01

To evaluate the clinical relief from dentin hypersensitivity among subjects provided with a dentifrice formulated with 8% arginine, calcium carbonate and 1,000 ppm fluoride [sodium monofluorophosphate (MFP)] in comparison to those issued a commercially available dentifrice containing 1,000 ppm fluoride [as sodium monofluorophosphate (MFP)]. Clinical evaluations for hypersensitivity were performed with a novel tactile hypersensitivity measuring instrument--the Jay Sensitivity Sensor (Jay) Probe--in conjunction with evaporative triggers by air blast (Schiff scale) and Visual Analog Scores (VAS). Qualified adults from the Mangalore, India area who presented two teeth with dentin hypersensitivity were enrolled for this double-blind, randomized, parallel, controlled clinical trial conducted in an outpatient clinical setting. At baseline, dentin hypersensitivity was evaluated by the Jay Probe (tactile), air blast and VAS methods. Subjects were randomly issued a study dentifrice and instructed to brush their teeth for 1 minute twice daily with the provided dentifrice. Clinical evaluations for hypersensitivity were repeated after 2, 4 and 8 weeks of product use. 86 subjects (35 males and 51 females) complied with the study protocol and completed the entire study. At each recall visit, both treatment groups demonstrated significant reductions in dentin hypersensitivity from their corresponding baselines (P < 0.05). Subjects assigned the 8% arginine, calcium carbonate and 1,000 ppm fluoride dentifrice demonstrated statistically significant reductions in responses to tactile stimuli, air blast, and VAS responses in comparison to those using the dentifrice containing 1,000 ppm fluoride after 2, 4, and 8 weeks, respectively.

Is there a correlation between physicians' clinical impressions and patients' perceptions of change? Use of the Perceived Change Scale with inpatients with mental disorders.

PubMed

Pavan, Gabriela; Godoy, Julia Almeida; Monteiro, Ricardo Tavares; Moreschi, Hugo Karling; Nogueira, Eduardo Lopes; Spanemberg, Lucas

2016-01-01

Assessment of the results of treatment for mental disorders becomes more complete when the patient's perspective is incorporated. Here, we aimed to evaluate the psychometric properties and application of the Perceived Change Scale - Patient version (PCS-P) in a sample of inpatients with mental disorders. One hundred and ninety-one psychiatric inpatients answered the PCS-P and the Patients' Satisfaction with Mental Health Services Scale (SATIS) and were evaluated in terms of clinical and sociodemographic data. An exploratory factor analysis (EFA) was performed and internal consistency was calculated. The clinical impressions of the patient, family, and physician were correlated with the patient's perception of change. The EFA indicated a psychometrically suitable four-factor solution. The PCS-P exhibited a coherent relationship with SATIS and had a Cronbach's alpha value of 0.856. No correlations were found between the physician's clinical global impression of improvement and the patient's perception of change, although a moderate positive correlation was found between the patients' clinical global impression of improvement and the change perceived by the patient. The PCS-P exhibited adequate psychometric proprieties in a sample of inpatients with mental disorders. The patient's perception of change is an important dimension for evaluation of outcomes in the treatment of mental disorders and differs from the physician's clinical impression of improvement. Evaluation of positive and negative perceptions of the various dimensions of the patient's life enables more precise consideration of the patient's priorities and interests.

Determinants and effects of medical students' core self-evaluation tendencies on clinical competence and workplace well-being in clerkship.

PubMed

Lin, Yung Kai; Chen, Der-Yuan; Lin, Blossom Yen-Ju

2017-01-01

Core self-evaluation (CSE) is a personality trait that involves a person's evaluation of his or her own worth, competence, and capability. The objective of this study was to determine whether medical students' CSEs exert beneficial effects on their adaptation to their clerkship in terms of their clinical competence and workplace well-being and whether their preclinical academic performance can be a trait-relevant situation that enhances their CSE expression. In total, 127 medical students from 2 cohorts were included as participants in this study. We analyzed complete measures of personal background, objective and subjective preclinical academic performance (course evaluation grades and self-reported efficacy), CSE tendencies, and clinical competence (as objective structured clinical examination scores) and workplace well-being (as compassion satisfaction and burnout) during their 2-year clerkship. Mixed linear models for repeated measures and multiple regressions were employed. Participants' CSE tendencies had positive effects on their workplace compassion satisfaction and burnout but not on their clinical competence during their clerkship. Additionally, using the objective and subjective preclinical academic performance of the medical students as indicators, we observed that neither could be trait-relevant situations to enhance their CSE expression. CSE personality tendencies might be key to medical students' ability to noncognitively adapt to clinical training during their clerkships. These tendencies should be identified earlier so that mentors can provide prompt care and support to mentees (medical students) during clerkships.

Efficacy and safety of naftifine HCl Gel 2% in the treatment of interdigital and moccasin type tinea pedis: pooled results from two multicenter, randomized, double-blind, vehicle-controlled trials.

PubMed

Stein Gold, Linda F; Parish, Lawrence Charles; Vlahovic, Tracey; Plaum, Stefan; Kircik, Leon; Fleischer, Alan B; Verma, Amit; Olayinka, Babajide; Hardas, Bhushan

2013-08-01

Tinea pedis is the most common chronic fungal infection. Naftifine hydrochloride is a topical antifungal of the allylamine class, displaying fungicidal activity and clinically significant anti-bacterial and anti-inflammatory effects. To evaluate the efficacy and safety of two-weeks once daily application of naftifine gel 2% in the treatment of tinea pedis. At baseline, 1715 subjects were randomly assigned 2:1 to naftifine gel 2% (n=1144) and vehicle (n=571). Efficacy consisting of mycologic determination (KOH and dermatophyte cultures) and scoring of clinical symptom severity was evaluated at baseline and weeks 2, 4, and 6. Efficacy was analyzed in 1174 subjects (n=782, naftifine; n=392, vehicle) with a positive baseline dermatophyte culture and KOH for whom week 6 assessments were available. Safety was evaluated by adverse events (AE) and laboratory values in 1714 subjects (n=1143, naftifine; n=571, vehicle). Subjects treated with naftifine gel 2% for interdigital-type tinea pedis demonstrated greater improvement from baseline for complete cure (P=0.001), mycological cure (P<0.0001), and treatment effectiveness (P<0.0001) as early as 2 weeks when compared to vehicle; however the highest response rates were seen 4-weeks post treatment (P<0.0001, for all endpoints). Statistically significant results for complete cure, mycological cure, and treatment effectiveness (P<0.0001, for all endpoints) were also seen at week 6 among subjects with moccasin-type tinea pedis. Treatment related adverse events were minimal. Treatment with naftifine gel 2% applied once daily for two weeks is well-tolerated and is effective in treating both interdigital-type and moccasin-type tinea pedis. Continuous improvement is observed from the end of treatment to four-weeks after treatment cessation among key outcome measures (complete cure, mycological cure, and treatment effectiveness) as well as clinical signs and symptoms (erythema, scaling, and pruritus)

Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

PubMed

Bowers, Alex R; Keeney, Karen; Peli, Eli

2014-02-01

There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition. To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia. Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline. Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks. The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms. Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference. Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia. clinicaltrials.gov Identifier: NCT00494676.

MO-F-CAMPUS-T-05: SQL Database Queries to Determine Treatment Planning Resource Usage

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

Fox, C; Gladstone, D

2015-06-15

Purpose: A radiation oncology clinic’s treatment capacity is traditionally thought to be limited by the number of machines in the clinic. As the number of fractions per course decrease and the number of adaptive plans increase, the question of how many treatment plans a clinic can plan becomes increasingly important. This work seeks to lay the ground work for assessing treatment planning resource usage. Methods: Care path templates were created using the Aria 11 care path interface. Care path tasks included key steps in the treatment planning process from the completion of CT simulation through the first radiation treatment. SQLmore » Server Management Studio was used to run SQL queries to extract task completion time stamps along with care path template information and diagnosis codes from the Aria database. 6 months of planning cycles were evaluated. Elapsed time was evaluated in terms of work hours within Monday – Friday, 7am to 5pm. Results: For the 195 validated treatment planning cycles, the average time for planning and MD review was 22.8 hours. Of those cases 33 were categorized as urgent. The average planning time for urgent plans was 5 hours. A strong correlation between diagnosis code and range of elapsed planning time was as well as between elapsed time and select diagnosis codes was observed. It was also observed that tasks were more likely to be completed on the date due than the time that they were due. Follow-up confirmed that most users did not look at the due time. Conclusion: Evaluation of elapsed planning time and other tasks suggest that care paths should be adjusted to allow for different contouring and planning times for certain diagnosis codes and urgent cases. Additional clinic training around task due times vs dates or a structuring of care paths around due dates is also needed.« less

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

PubMed

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

2015-02-01

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

Investigation of the prevalence, clinical features, and risk factors of dentin hypersensitivity in a selected Brazilian population.

PubMed

Scaramucci, Taís; de Almeida Anfe, Taciana Emília; da Silva Ferreira, Stella; Frias, Antônio Carlos; Sobral, Maria Angela Pita

2014-01-01

To evaluate the prevalence, clinical features, and risk factors of dentin hypersensitivity (DH) in a Brazilian population. 300 patients at the Dentistry Clinic of the University of São Paulo participated in this study. The subjects completed a questionnaire regarding their personal information, the presence of DH, and some of its risk factors. Following completion of the questionnaire, a clinical examination was undertaken. To confirm the presence of DH, the subjects were evaluated with the use of a probe and cold air from a triple syringe. Statistical analysis was performed with the chi-square test and odds ratio, with the critical level p <0.05. The prevalence of DH was 46%. Females presented a higher prevalence than males (p <0.05). The left posterior region was affected by DH the most (maxilla = 41% and mandible = 36%). Cold was reported as the most common pain-inducing stimulus (88%). The pain was described as "discomfort" by 51% of the subjects with DH. Toothbrushing four times a day (p <0.05), toothbrushing with excessive force (p <0.05), bruxism (p <0.05), and gastroesophageal reflux (p <0.05) were strongly correlated with DH. The prevalence of DH was particularly high. The risk factors for DH were gender (female), toothbrushing four times a day, toothbrushing with excessive force, bruxism, and gastroesophageal reflux. DH was a common finding in this population suggesting that preventive measures considering its risk factors must be implemented in order to reduce or control the symptoms.

Acellular dermal matrix graft for gingival augmentation: a preliminary clinical, histologic, and ultrastructural evaluation.

PubMed

Scarano, Antonio; Barros, Raquel R M; Iezzi, Giovanna; Piattelli, Adriano; Novaes, Arthur B

2009-02-01

The aim of this study was to evaluate clinically, histologically, and ultrastructurally the integration process of the acellular dermal matrix used to increase the band of keratinized tissue while achieving gingival inflammation control. Ten patients exhibiting a mucogingival problem with bands of keratinized tissue

Effects of an experiential learning program on the clinical reasoning and critical thinking skills of occupational therapy students.

PubMed

Coker, Patty

2010-01-01

This study examined the effects of participation in a 1-week, experiential, hands-on learning program on the critical thinking and clinical reasoning skills of occupational therapy students. A quasi-experimental, nonrandomized pre- and post-test design was used with a sample of 25 students. The students had completed three semesters of didactic lecture coursework in a master's level OT educational program prior to participation in a hands-on therapy program for children with hemiplegic cerebral palsy. Changes in critical thinking and clinical reasoning skills were evaluated using the following dependent measures: Self-Assessment of Clinical Reflection and Reasoning (SACRR) and the California Critical Thinking Skills Test (CCTST). Changes in pretest and posttest scores on the SACRR and the CCTST were statistically significant (p>0.05) following completion of the experiential learning program. This study supports the use of hands-on learning to develop clinical reasoning and critical thinking skills in healthcare students, who face ever more diverse patient populations upon entry-level practice. Further qualitative and quantitative investigations are needed to support the results of this study and determine which components of experiential learning programs are essential for developing clinical reasoning and critical thinking skills in future allied health professionals.

Lea's Shield, a new barrier contraceptive preliminary clinical evaluations three-day tolerance study.

PubMed

Hunt, W L; Gabbay, L; Potts, M

1994-12-01

In this study the Lea's Shield was evaluated for its tolerance by women who wore the device for three consecutive days. Ten women who wore the Lea's Shield for 72 hours completed the tolerance study without adverse effects. Examination of the cervix and vagina revealed that the device did not provoke any significant cellular or microbial changes among the wearers. No major changes in the appearance or prevalence of vaginal flora occurred in the women after three days of wearing the device. A gradient in the pH could be detected between the contents of the vagina, which was more acidic than the contents of the bowl of the device. The range of cervical shapes and vaginal morphology among the study participants has had no influence upon the ability of the device to remain in its proper position. The device "settles in place" as it is pushed in, thereby obviating any special maneuvers for proper positioning. No vaginal nor cervical trauma occurred. We have concluded from these basic clinical evaluations that Lea's Shield is well tolerated during three days of use. Efficacy trials in women at risk recently completed have confirmed the high degree of acceptability and that the device can function adequately as one size fits all.

Polish Adaptation of Wrist Evaluation Questionnaires.

PubMed

Czarnecki, Piotr; Wawrzyniak-Bielęda, Anna; Romanowski, Leszek

2015-01-01

Questionnaires evaluating hand and wrist function are a very useful tool allowing for objective and systematic recording of symptoms reported by the patients. Most questionnaires generally accepted in clinical practice are available in English and need to be appropriately adapted in translation and undergo subsequent validation before they can be used in another culture and language. The process of translation of the questionnaires was based on the generally accepted guidelines of the International Quality of Life Assessment Project (IQOLA). First, the questionnaires were translated from English into Polish by two independent translators. Then, a joint version of the translation was prepared collectively and translated back into English. Each stage was followed by a written report. The translated questionnaires were then evaluated by a group of patients. We selected 31 patients with wrist problems and asked them to complete the PRWE, Mayo, Michigan and DASH questionnaires twice at intervals of 3-10 days. The results were submitted for statistical analysis. We found a statistically significant (p<0.05) correlation for the two completions of the questionnaires. A comparison of the PRWE and Mayo questionnaires with the DASH questionnaire also showed a statistically significant correlation (p<0.05). Our results indicate that the cultural adaptation of the translated questionnaires was successful and that the questionnaires may be used in clinical practice.

Implementation of a fall screening program in a high risk of fracture population.

PubMed

Ritchey, Katherine; Olney, Amanda; Shofer, Jane; Phelan, Elizabeth A; Matsumoto, Alvin M

2017-10-31

Fall prevention is an important way to prevent fractures in person with osteoporosis. We developed and implemented a fall screening program in the context of routine osteoporosis care. This program was found to be feasible and showed that a significant proportion of persons with osteoporosis are at risk of falling. Falls are the most common cause of fracture in persons with osteoporosis. However, osteoporosis care rarely includes assessment and prevention of falling. We thus sought to assess the feasibility of a fall screening and management program integrated into routine osteoporosis care. The program was developed and offered to patients with osteoporosis or osteopenia seen at an outpatient clinic between May 2015 and May 2016. Feasibility was measured by physical therapist time required to conduct screening and ease of integrating the screening program into the usual clinic workflow. Self-report responses and mobility testing were conducted to describe the fall and fracture risk profile of osteoporosis patients screened. Effects on fall-related care processes were assessed via chart abstraction of patient participation in fall prevention exercise. Of the 154 clinic patients who presented for a clinic visit, 68% met screening criteria and completed in two thirds of persons. Screening was completed in a third of the time typically allotted for traditional PT evaluations and did not interfere with clinic workflow. Forty percent of those screened reported falling in the last year, and over half had two or more falls in the past year. Over half reported a balance or lower extremity impairment, and over 40% were below norms on one or more performance tests. Most patients who selected a group exercise fall prevention program completed all sessions while only a quarter completed either supervised or independent home-based programs. Implementation of a fall risk screening program in an outpatient osteoporosis clinic appears feasible. A substantial proportion of people with osteoporosis screened positive for being at risk of falling, justifying integration of fall prevention into routine osteoporosis care.

Evaluating a Brief, Video-Based Sexual Risk Reduction Intervention and Assessment Reactivity with STI Clinic Patients: Results from a Randomized Controlled Trial

PubMed Central

Carey, Michael P.; Senn, Theresa E.; Walsh, Jennifer L.; Coury-Doniger, Patricia; Urban, Marguerite A.; Fortune, Thierry; Vanable, Peter A.; Carey, Kate B.

2014-01-01

We report results from a randomized controlled trial designed to evaluate the efficacy of a video-based sexual risk reduction intervention and to measure assessment reactivity. Patients (N = 1010; 56 % male; 69 % African American) receiving care at a sexually transmitted infection (STI) clinic were assigned to one of four conditions formed by crossing assessment condition (i.e., sexual health vs. general health) with intervention condition (i.e., sexual risk reduction intervention vs. general health promotion). After completing their assigned baseline assessment, participants received their assigned intervention, and subsequently returned for follow-up assessments at 3, 6, 9, and 12 months. Participants in all conditions reduced their self-reported sexual risk behavior, and the incidence of new STIs declined from baseline through the follow-ups; however, there was no effect of intervention or assessment condition. We conclude that further risk reduction will require more intensive interventions, especially in STI clinics that already provide excellent clinical care. PMID:25433653

Clinical and histologic evaluation of calcium-phosphate bone cement in interproximal osseous defects in humans: a report in four patients.

PubMed

Mellonig, James T; Valderrama, Pilar; Cochran, David L

2010-04-01

This study evaluated the clinical and histologic results of a calcium phosphate bone cement in the treatment of human periodontal intraosseous defects. Four patients with chronic advanced periodontitis in whom treatment with complete dentures was planned were recruited. The cement was implanted in one defect per subject with a presurgical probing depth of at least 7 mm and a radiographic bone defect of 4 mm or more. Patients were seen every 2 weeks for periodontal maintenance. At 6 months, clinical measurements were repeated and the tooth was removed en bloc for histologic processing. Results demonstrated that all defects resulted in probing depth reduction and, at three of the four defects, in clinical attachment level gain. However, no site showed periodontal regeneration. There was no new bone formation. New cementum and connective tissue were limited to 0.2 mm or less. Large deposits of the bone cement were noted encapsulated in connective tissue.

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

PubMed

Lewis-Fernández, Roberto; Aggarwal, Neil Krishan; Lam, Peter C; Galfalvy, Hanga; Weiss, Mitchell G; Kirmayer, Laurence J; Paralikar, Vasudeo; Deshpande, Smita N; Díaz, Esperanza; Nicasio, Andel V; Boiler, Marit; Alarcón, Renato D; Rohlof, Hans; Groen, Simon; van Dijk, Rob C J; Jadhav, Sushrut; Sarmukaddam, Sanjeev; Ndetei, David; Scalco, Monica Z; Bassiri, Kavoos; Aguilar-Gaxiola, Sergio; Ton, Hendry; Westermeyer, Joseph; Vega-Dienstmaier, Johann M

2017-04-01

Background There is a need for clinical tools to identify cultural issues in diagnostic assessment. Aims To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Method Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Results Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. Conclusions The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool. © The Royal College of Psychiatrists 2017.

Qualitative analysis of student beliefs and attitudes after an objective structured clinical evaluation: implications for affective domain learning in undergraduate nursing education.

PubMed

Cazzell, Mary; Rodriguez, Amber

2011-12-01

This qualitative study explored the feelings, beliefs, and attitudes of senior-level undergraduate pediatric nursing students upon completion of a medication administration Objective Structured Clinical Evaluation (OSCE). The affective domain is the most neglected domain in higher education, although it is deemed the "gateway to learning." Quantitative assessments of clinical skills performed during OSCEs usually address two of the three domains of learning: cognitive (knowledge) and psychomotor skills. Twenty students volunteered to participate in focus groups (10 per group) and were asked three questions relevant to their feelings, beliefs, and attitudes about their OSCE experiences. Students integrated the attitude of safety first into future practice but felt that anxiety, loss of control, reaction under pressure, and no feedback affected their ability to connect the OSCE performance with future clinical practice. The findings affect future affective domain considerations in the development, modification, and assessment of OSCEs across the undergraduate nursing curriculum.

The effects of implementing synoptic pathology reporting in cancer diagnosis: a systematic review.

PubMed

Sluijter, Caro E; van Lonkhuijzen, Luc R C W; van Slooten, Henk-Jan; Nagtegaal, Iris D; Overbeek, Lucy I H

2016-06-01

Pathology reporting is evolving from a traditional narrative report to a more structured synoptic report. Narrative reporting can cause misinterpretation due to lack of information and structure. In this systematic review, we evaluate the impact of synoptic reporting on completeness of pathology reports and quality of pathology evaluation for solid tumours. Pubmed, Embase and Cochrane databases were systematically searched to identify studies describing the effect of synoptic reporting implementation on completeness of reporting and quality of pathology evaluation of solid malignant tumours. Thirty-three studies met the inclusion criteria. All studies, except one, reported an increased overall completeness of pathology reports after introduction of synoptic reporting (SR). Most frequently studied cancers were breast (n = 9) and colorectal cancer (n = 16). For breast cancer, narrative reports adequately described 'tumour type' and 'nodal status'. Synoptic reporting resulted in improved description of 'resection margins', 'DCIS size', 'location' and 'presence of calcifications'. For colorectal cancer, narrative reports adequately reported 'tumour type', 'invasion depth', 'lymph node counts' and 'nodal status'. Synoptic reporting resulted in increased reporting of 'circumferential margin', 'resection margin', 'perineural invasion' and 'lymphovascular invasion'. In addition, increased numbers of reported lymph nodes were found in synoptic reports. Narrative reports of other cancer types described the traditional parameters adequately, whereas for 'resection margins' and '(lympho)vascular/perineural invasion', implementation of synoptic reporting was necessary. Synoptic reporting results in improved reporting of clinical relevant data. Demonstration of clinical impact of this improved method of pathology reporting is required for successful introduction and implementation in daily pathology practice.

Development and evaluation of a risk communication curriculum for medical students.

PubMed

Han, Paul K J; Joekes, Katherine; Elwyn, Glyn; Mazor, Kathleen M; Thomson, Richard; Sedgwick, Philip; Ibison, Judith; Wong, John B

2014-01-01

To develop, pilot, and evaluate a curriculum for teaching clinical risk communication skills to medical students. A new experience-based curriculum, "Risk Talk," was developed and piloted over a 1-year period among students at Tufts University School of Medicine. An experimental study of 2nd-year students exposed vs. unexposed to the curriculum was conducted to evaluate the curriculum's efficacy. Primary outcome measures were students' objective (observed) and subjective (self-reported) risk communication competence; the latter was assessed using an Observed Structured Clinical Examination (OSCE) employing new measures. Twenty-eight 2nd-year students completed the curriculum, and exhibited significantly greater (p<.001) objective and subjective risk communication competence than a convenience sample of 24 unexposed students. New observational measures of objective competence in risk communication showed promising evidence of reliability and validity. The curriculum was resource-intensive. The new experience-based clinical risk communication curriculum was efficacious, although resource-intensive. More work is needed to develop the feasibility of curriculum delivery, and to improve the measurement of competence in clinical risk communication. Risk communication is an important advanced communication skill, and the Risk Talk curriculum provides a model educational intervention and new assessment tools to guide future efforts to teach and evaluate this skill. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

[Features of Clinical Register of Chinese Medicine and Pharmacy Based on ClinicalTrials.gov. (USA)].

PubMed

Lu, Peng-fei; Liao, Xing; Xie, Yan-ming; Wang, Zhi-guo

2015-11-01

In recent 10 years, clinical trials of Chinese medicine and pharmacy (cMP) at clinicalTrials.gov.(USA) are gradually increasing. In order to analyze features of CMP clinical register, ClinicalTrials.gov register database were comprehensively retrieved in this study. Included clinical trials were input one item after another using EXCEL. A final of 348 CMP clinical trials were included. Results showed that China occupied the first place in CMP clinical register, followed by USA. CMP clinical trials, sponsored mainly by colleges/universities and hospitals, mostly covered interventional studies on evaluating safety/effectiveness of CMP. The proportions of studies, sponsored by mainland China and companies, recruitment trials and multi-center clinical trials in interventional trials were increasing. The proportions of studies sponsored by Hong Kong and Taiwan, research completed trials, unclear research status, phase III clinical trials, and published research trials in interventional trials were decreasing. Published ratios of CMP clinical trials were quite low. There were more missing types and higher proportions in trial register information.

Electronic Rapid Fitness Assessment: A Novel Tool for Preoperative Evaluation of the Geriatric Oncology Patient

PubMed Central

Shahrokni, Armin; Tin, Amy; Downey, Robert J.; Strong, Vivian; Mahmoudzadeh, Sanam; Boparai, Manpreet K.; McMillan, Sincere; Vickers, Andrew; Korc-Grodzicki, Beatriz

2017-01-01

Background The American College of Surgeons and American Geriatrics Society recommend performing a geriatric assessment (GA) in the preoperative evaluation of older patients. To address this, we developed an electronic GA; the Electronic Rapid Fitness Assessment (eRFA). We reviewed the feasibility and clinical utility of the eRFA in the preoperative evaluation of geriatric patients. Methods We performed a retrospective review of our experience using the eRFA in the preoperative assessment of geriatric patients. The rate of and time to completion of the eRFA were recorded. The first 50 patients who completed the assessment were asked additional questions to assess their satisfaction. Descriptive statistics of patient-reported geriatric-related data were used for analysis. Results In 2015, 636 older cancer patients (median age, 80 years) completed the eRFA during preoperative evaluation. The median time to completion was 11 minutes (95% CI, 11 to 12 minutes). Only 13% of patients needed someone else to complete the assessment for them. Of the first 50 patients, 90% (95% CI, 75% to 98%) responded that answering questions by using eRFA was easy. Geriatric syndromes were commonly identified through the performance of the GA: 16% of patients had a positive screening for cognitive impairment, 22% (95% CI, 19% to 26%) needed a cane to ambulate, and 26% (95% CI, 23% to 30%) had fallen at least once during the previous year. Conclusion Implementation of the eRFA was feasible. The eRFA identified relevant geriatric syndromes in the preoperative setting that, if addressed, could lead to improved outcomes. PMID:28188187

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

PubMed

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

2018-05-22

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

Rapidly-administered short forms of the Wechsler Adult Intelligence Scale-3rd edition.

PubMed

Donnell, Alison J; Pliskin, Neil; Holdnack, James; Axelrod, Bradley; Randolph, Christopher

2007-11-01

Although the Wechsler Full Scale IQ (FSIQ) is a common component of most neuropsychological evaluations, there are many clinical situations where the complete administration of this battery is precluded by various constraints, including limitations of time and patient compliance. These constraints are particularly true for dementia evaluations involving elderly patients. The present study reports data on two short forms particularly suited to dementia evaluations, each requiring less than 20min of administration time. One of the short forms was previously validated in dementia for the WAIS-R [Randolph, C., Mohr, E., & Chase, T. N. (1993). Assessment of intellectual function in dementing disorders: Validity of WAIS-R short forms for patients with Alzheimer's, Huntington's, and Parkinson's disease. Journal of Clinical and Experimental Neuropsychology, 15, 743-753]; the second was developed specifically for patients with motor disabilities. These short forms were validated using the WAIS-III normative standardization sample (N=2450), neurologic sample (N=63), and matched controls (N=49), and a separate mixed clinical sample (N=70). The results suggest that each short form provides an accurate and reliable estimate of WAIS-III FSIQ, validating their use in appropriate clinical contexts. The present data support the use of these short forms for dementia evaluations, and suggests that they may be applicable for the evaluation of other neurological and neuropsychiatric disorders that involve acquired neurocognitive impairment.

Clinical picture and treatment implication in a child with Capgras syndrome: a case report.

PubMed

Mazzone, Luigi; Armando, Marco; De Crescenzo, Franco; Demaria, Francesco; Valeri, Giovanni; Vicari, Stefano

2012-11-27

Capgras syndrome is a delusional misidentification syndrome characterized by the patient's belief that his or her relatives have been replaced by impostors. Here we describe the clinical picture and the therapeutic approach to an 11-year-old Caucasian girl with Capgras syndrome. A complete psychopathological assessment was conducted during the acute phase, at one month, two months and six months since diagnosis. Subsequent follow-up evaluations in this patient allowed us to detect improvements in the psychotic symptoms following treatment with risperidone and selective serotonin reuptake inhibitors, suggesting that this combined therapy may significantly improve the clinical outcome in patients who have Capgras syndrome.

A telehealth approach to conducting clinical swallowing evaluations in children with cerebral palsy.

PubMed

Kantarcigil, Cagla; Sheppard, Justine Joan; Gordon, Andrew M; Friel, Kathleen M; Malandraki, Georgia A

2016-08-01

Accurate and timely evaluation of dysphagia in children with cerebral palsy (CP) is critical. For children with limited access to quality healthcare, telehealth is an option; however, its reliability needs to be investigated. To test the reliability of an asynchronous telehealth model for evaluating dysphagia in children with CP using a standardized clinical assessment. Nineteen children (age range 6.9-17.5) were assessed at three mealtimes via the Dysphagia Disorder Survey (DDS) by three clinicians (face-to-face evaluations). Mealtimes were video-recorded to allow asynchronous evaluations by a remote clinician who also completed approximately 1/3 of face-to-face evaluations. Agreement was tested on DDS variables and dysphagia severity. Results revealed substantial to excellent agreement between face-to-face and remote assessments by the same rater (78-100%, KW=0.64-1) on all, but two variables (oral transport and oral pharyngeal swallow) and by different raters (69-89%, KW=0.6-0.86) on all but one variable (orienting). For dysphagia severity, intrarater agreement was excellent (100%, KW=1); interrater agreement was substantial (85%; KW=0.76). Asynchronous clinical swallowing evaluations using standardized tools have acceptable levels of agreement with face-to-face evaluations, and can be an alternative for children with limited access to expert swallowing care. Copyright © 2016 Elsevier Ltd. All rights reserved.

Neural basis of nonanalytical reasoning expertise during clinical evaluation.

PubMed

Durning, Steven J; Costanzo, Michelle E; Artino, Anthony R; Graner, John; van der Vleuten, Cees; Beckman, Thomas J; Wittich, Christopher M; Roy, Michael J; Holmboe, Eric S; Schuwirth, Lambert

2015-03-01

Understanding clinical reasoning is essential for patient care and medical education. Dual-processing theory suggests that nonanalytic reasoning is an essential aspect of expertise; however, assessing nonanalytic reasoning is challenging because it is believed to occur on the subconscious level. This assumption makes concurrent verbal protocols less reliable assessment tools. Functional magnetic resonance imaging was used to explore the neural basis of nonanalytic reasoning in internal medicine interns (novices) and board-certified staff internists (experts) while completing United States Medical Licensing Examination and American Board of Internal Medicine multiple-choice questions. The results demonstrated that novices and experts share a common neural network in addition to nonoverlapping neural resources. However, experts manifested greater neural processing efficiency in regions such as the prefrontal cortex during nonanalytical reasoning. These findings reveal a multinetwork system that supports the dual-process mode of expert clinical reasoning during medical evaluation.

Does incorporation of a clinical support template in the electronic medical record improve capture of wound care data in a cohort of veterans with diabetic foot ulcers?

PubMed

Lowe, Jeanne R; Raugi, Gregory J; Reiber, Gayle E; Whitney, Joanne D

2013-01-01

The purpose of this cohort study was to evaluate the effect of a 1-year intervention of an electronic medical record wound care template on the completeness of wound care documentation and medical coding compared to a similar time interval for the fiscal year preceding the intervention. From October 1, 2006, to September 30, 2007, a "good wound care" intervention was implemented at a rural Veterans Affairs facility to prevent amputations in veterans with diabetes and foot ulcers. The study protocol included a template with foot ulcer variables embedded in the electronic medical record to facilitate data collection, support clinical decision making, and improve ordering and medical coding. The intervention group showed significant differences in complete documentation of good wound care compared to the historic control group (χ = 15.99, P < .001), complete documentation of coding for diagnoses and procedures (χ = 30.23, P < .001), and complete documentation of both good wound care and coding for diagnoses and procedures (χ = 14.96, P < .001). An electronic wound care template improved documentation of evidence-based interventions and facilitated coding for wound complexity and procedures.

Predictors of dental rehabilitation in children aged 3-12 years.

PubMed

Gopinath, Vellore Kannan; Awad, Manal A

2015-01-01

The aim of this study was to evaluate the proportion of completed treatments and to study the factors affecting the full mouth dental rehabilitation in pediatric patients treated by undergraduate students at the College of Dental Medicine Teaching Clinics, University of Sharjah. A retrospective study was conducted on 270 children aged less than 12 years (mean age 7.6, SD 2.04). Comprehensive dental rehabilitation reports of child patients that were completed by final year dental undergraduate students from the year 2009 to 2011 were reviewed. Data on complete history, oral examination, dental charting, and treatment plan were collected from pediatric dentistry case sheet. Dental caries was charted using WHO 1997 criteria. Dental treatment needs and completion of dental care delivered to children involved in this study were assessed using DMFT/deft scores. Percentages of treatment provided included completed restorations (94%) and space management (84%) in primary dentition, whereas 98% of restoration and 94% of required sealants were completed in permanent dentition. The percentage of completed dental treatment including sealant placement was 61%. Age of the child and the number of decayed teeth present before the start of the treatment significantly correlated with the children in the incomplete treatment category (P < 0.05). Therefore, a worthy dental care was provided in a holistic approach to the children attending College of Dental Medicine training clinics. Age of the child and the number of decayed teeth were the factors affecting dental rehabilitation in children aged 3-12 years.

Competency champions in the clinical competency committee: a successful strategy to implement milestone evaluations and competency coaching.

PubMed

Ketteler, Erika R; Auyang, Edward D; Beard, Kathy E; McBride, Erica L; McKee, Rohini; Russell, John C; Szoka, Nova L; Nelson, M Timothy

2014-01-01

To create a clinical competency committee (CCC) that (1) centers on the competency-based milestones, (2) is simple to implement, (3) creates competency expertise, and (4) guides remediation and coaching of residents who are not progressing in milestone performance evaluations. We created a CCC that meets monthly and at each meeting reviews a resident class for milestone performance, a competency (by a faculty competency champion), a resident rotation service, and any other resident or issue of concern. University surgical residency program. The CCC members include the program director, associate program directors, director of surgical curriculum, competency champions, departmental chair, 2 at-large faculty members, and the administrative chief residents. Seven residents were placed on remediation (later renamed as coaching) during the academic year after falling behind on milestone progression in one or more competencies. An additional 4 residents voluntarily placed themselves on remediation for medical knowledge after receiving in-training examination scores that the residents (not the CCC membership) considered substandard. All but 2 of the remediated/coached residents successfully completed all area milestone performance but some chose to stay on the medical knowledge competency strategy. Monthly meetings of the CCC make milestone evaluation less burdensome. In addition, the expectations of the residents are clearer and more tangible. "Competency champions" who are familiar with the milestones allow effective coaching strategies and documentation of clear performance improvements in competencies for successful completion of residency training. Residents who do not reach appropriate milestone performance can then be placed in remediation for more formal performance evaluation. The function of our CCC has also allowed us opportunity to evaluate the required rotations to ensure that they offer experiences that help residents achieve competency performance necessary to be safe and effective surgeons upon completion of training. © 2013 Published by Association of Program Directors in Surgery on behalf of Association of Program Directors in Surgery.

Virtual colonoscopy, optical colonoscopy, or fecal occult blood testing for colorectal cancer screening: results of a pilot randomized controlled trial.

PubMed

You, John J; Liu, Yudong; Kirby, John; Vora, Parag; Moayyedi, Paul

2015-07-09

No head-to-head randomized controlled trials have demonstrated the superiority of one colorectal screening modality over another in reducing colorectal cancer mortality. We conducted a pilot randomized controlled trial of fecal occult blood testing (FOBT), optical colonoscopy (OC), and virtual colonoscopy (VC), to inform the planning of a larger evaluative trial. Eligible patients (aged 50 to 70) were recruited from five primary care practices in Hamilton, ON, Canada, between March 23, 2010 and August 11, 2010, and randomized 1:1:1 in a parallel design using an automated, centralized telephone service to either FOBT, OC, or VC. To reflect conventional practice, patients received no additional reminders to complete their allocated screening test beyond those received in usual practice. The primary outcome was completion of the assigned screening procedure. Results of the index test and any follow-up investigations were ascertained at 6 months. Participants, caregivers, and outcome assessors were not blinded to group assignment. The trial was stopped early due to lack of ongoing funding. A total of 198 participants were enrolled, of whom 67 were allocated to FOBT, 66 to OC, and 65 to VC. The allocated screening procedure was completed by 43 (64%) subjects allocated to FOBT (95% confidence interval [CI], 52-75%), 53 (80%) subjects allocated to OC (95% CI, 69-88%), and 50 (77%) subjects allocated to VC (95% CI, 65-85%); because the trial stopped early, we had insufficient statistical power to detect clinically relevant differences in completion rates. During 6 months follow-up, colorectal adenomas were detected in 0 (0%) subjects allocated to FOBT, 12 (18%) subjects allocated to OC, and 2 (3%) subjects allocated to VC. One subject in the OC arm had histological evidence of high-grade dysplasia. No subjects were diagnosed with colorectal cancer. In this pilot randomized controlled trial of colorectal cancer screening in a primary care setting, 64-80% of subjects completed their allocated screening test. These findings may be of value to investigators planning clinical trials to evaluate the effectiveness of colorectal cancer screening. ClinicalTrials.gov NCT00865527. https://clinicaltrials.gov/ct2/show/NCT00865527.

[Perinatal Information System. Incorporation latency and impact on perinatal clinical registry].

PubMed

Simini, F; Fernández, A; Sosa, C; Díaz Rossello, J L

2001-10-01

The Perinatal Information System (SIP) is a clinical record, local management and quality assurance software standard in Latin America and the Caribbean. The time to implement SIP in a Maternity Hospital is evaluated as well as the effect of statistics on perinatal health indicators in subsequent years. In the sample of 20 Maternity Hospitals (5 Countries, 40% Private and 60% Public) 85% had a reliable information system by the third year of use of SIP. 15% of hospitals still had problems at that time that were already clear during the second year, a time corrective measures can still be taken. The evaluation of the impact of yearly reports shows that 58% of recommendations were fulfilled, specially those regarding the complete filling-in of clinical records (62%) and to a lesser extent variables that reflect clinical practices and organization of services (52%). The conclusion is that Maternity Hospitals in Latin America and the Caribbean have the capacity to adopt a complex tool of computerized clinical records for quality assurance of perinatal care and monitoring of health indicators.

Efficacy, safety and tolerability of an optimized avulsion technique with onyster® (40% urea ointment with plastic dressing) ointment compared to bifonazole-urea ointment for removal of the clinically infected nail in toenail onychomycosis: a randomized evaluator-blinded controlled study.

PubMed

Lahfa, M; Bulai-Livideanu, C; Baran, R; Ortonne, J P; Richert, B; Tosti, A; Piraccini, B M; Szepietowski, J C; Sibaud, V; Coubetergues, H; Voisard, J J; Paul, C

2013-01-01

Toenail onychomycosis is highly prevalent, with 14-28% of people aged 60 or over suffering from the disease. Use of a topical antifungal alone in toenail onychomycosis is associated with low cure rates. This may be due to limited penetration of the topical antifungal through the diseased nail. The objective of the present study was to compare two treatment modalities to obtain diseased nail chemical avulsion in toenail onychomycosis. In this European, multicenter, randomized, parallel-group, open-label, active-controlled study, male or female adult patients with distal-lateral or lateral subungual dermatophyte onychomycosis on at least 12.5% of the great toenail were randomized either to a 40% urea ointment with plastic dressing group (n = 53) or to a bifonazole-urea ointment group (n = 52). The ointments were applied daily for a maximum of 3 weeks according to the summary of product characteristics. After assessment of infected nail debridement, topical antifungal treatment with bifonazole cream was applied daily in both groups for 8 weeks. 102 patients were evaluated, i.e. 51 in the 40% urea ointment with plastic dressing group and 51 in the bifonazole-urea group. The primary end point was complete removal of the nail plate at day 21 (D21). Secondary end points were: complete cure and mycological cure evaluated at D105. Ease of use and local tolerability were also assessed. Complete removal of the clinically infected target nail plate area, assessed by blinded evaluators, was significantly higher in the 40% urea ointment with plastic dressing group (61.2%) than in the control group (39.2%), showing the superiority of 40% urea ointment with plastic dressing (p = 0.028). The same results were observed in the per-protocol population (63.0 vs. 36.6%; p = 0.014). Complete removal of the infected area assessed by the investigator at D21 showed a significantly higher success rate in patients treated with 40% urea ointment with plastic dressing (86.3%) as compared to patients treated with bifonazole-urea (60.8%), confirming the superiority of 40% urea ointment with plastic dressing (p = 0.004). At D105, the complete cure of onychomycosis, a criterion combining clinical and mycological assessments, showed a success rate of 27.7% for 40% urea ointment with plastic dressing versus 20.8% for the control group. No statistical difference was observed between the two treatment groups. The number of patients with at least one adverse event was twice as high in the bifonazole-urea group in comparison to the 40% urea ointment with plastic dressing group. Overall assessment of local tolerability by the investigator was considered good/very good in 98.0% of the 40% urea ointment with plastic dressing patients versus 90.4% of the bifonazole-urea patients, at D21, with no significant difference between both groups. This study shows the superiority of 40% urea ointment with plastic dressing to bifonazole-urea ointment for complete removal of the infected target nail assessed by blinded evaluators and by the investigators. Further studies are needed to assess the impact of preliminary chemical nail avulsion on the efficacy of topical treatment of onychomycosis as assessed by complete cure at 1 year. Copyright © 2013 S. Karger AG, Basel.

Improving mammography screening among the medically underserved.

PubMed

Davis, Terry C; Rademaker, Alfred; Bennett, Charles L; Wolf, Michael S; Carias, Edson; Reynolds, Cristalyn; Liu, Dachao; Arnold, Connie L

2014-04-01

We evaluated the effectiveness and cost-effectiveness of alternative interventions designed to promote mammography in safety-net settings. A three-arm, quasi-experimental evaluation was conducted among eight federally qualified health clinics in predominately rural Louisiana. Mammography screening efforts included: 1) enhanced care, 2) health literacy-informed education of patients, and 3) education plus nurse support. Outcomes included mammography screening completion within 6 months and incremental cost-effectiveness. Overall, 1,181 female patients ages 40 and over who were eligible for routine mammography were recruited. Baseline screening rates were < 10%. Post intervention screening rates were 55.7% with enhanced care, 51.8% with health literacy-informed education and 65.8% with education and nurse support. After adjusting for race, marital status, self-efficacy and literacy, patients receiving health-literacy informed education were not more likely to complete mammographic screening than those receiving enhanced care; those additionally receiving nurse support were 1.37-fold more likely to complete mammographic screening than those receiving the brief education (95% Confidence Interval 1.08-1.74, p = 0.01). The incremental cost per additional women screened was $2,457 for literacy-informed education with nurse support over literacy-informed education alone. Mammography rates were increased substantially over existing baseline rates in all three arms with the educational initiative, with nurse support and follow-up being the most effective option. However, it is not likely to be cost-effective or affordable in resource-limited clinics.

Predictive value of the korean academy of family medicine in-training examination for certifying examination.

PubMed

Cho, Jung-Jin; Kim, Ji-Yong

2011-09-01

In-training examination (ITE) is a cognitive examination similar to the written test, but it is different from the Clinical Practice Examination of the Korean Academy of Family Medicine (KAFM) Certification Examination (CE). The objective of this is to estimate the positive predictive value of the KAFM-ITE for identifying residents at risk for poor performance on the three types of KAFM-CE. 372 residents who completed the KAFM-CE in 2011 were included. We compared the mean KAFM-CE scores with ITE experience. We evaluated the correlation and the positive predictive value (PPV) of ITE for the multiple choice question (MCQ) scores of 1st written test & 2nd slide examination, the total clinical practice examination scores, and the total sum of 2nd test. 275 out of 372 residents completed ITE. Those who completed ITE had significantly higher MCQ scores of 1st written test than those who did not. The correlation of ITE scores with 1st written MCQ (0.627) was found to be the highest among the other kinds of CE. The PPV of the ITE score for 1st written MCQ scores was 0.672. The PPV of the ITE score ranged from 0.376 to 0.502. The score of the KAFM ITE has acceptable positive predictive value that could be used as a part of comprehensive evaluation system for residents in cognitive field.

Using Poisson-gamma model to evaluate the duration of recruitment process when historical trials are available.

PubMed

Minois, Nathan; Lauwers-Cances, Valérie; Savy, Stéphanie; Attal, Michel; Andrieu, Sandrine; Anisimov, Vladimir; Savy, Nicolas

2017-10-15

At the design of clinical trial operation, a question of a paramount interest is how long it takes to recruit a given number of patients. Modelling the recruitment dynamics is the necessary step to answer this question. Poisson-gamma model provides very convenient, flexible and realistic approach. This model allows predicting the trial duration using data collected at an interim time with very good accuracy. A natural question arises: how to evaluate the parameters of recruitment model before the trial begins? The question is harder to handle as there are no recruitment data available for this trial. However, if there exist similar completed trials, it is appealing to use data from these trials to investigate feasibility of the recruitment process. In this paper, the authors explore the recruitment data of two similar clinical trials (Intergroupe Francais du Myélome 2005 and 2009). It is shown that the natural idea of plugging the historical rates estimated from the completed trial in the same centres of the new trial for predicting recruitment is not a relevant strategy. In contrast, using the parameters of a gamma distribution of the rates estimated from the completed trial in the recruitment dynamic model of the new trial provides reasonable predictive properties with relevant confidence intervals. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

[Evaluation of the radiofrequency ablation effectiveness in patients with the Wolff-Parkinson-White syndrome].

PubMed

Ushakov, I B; Ardashev, A V; Ardashev, V N; Voronkov, Iu I; Sharoĭko, M V; Akimova, O S

2012-01-01

A one-year prospective study involved 22 patients with the Wolff-Parkinson-White syndrome (WPW) and 20 healthy people. Means age of patients was 34.3 +/- 16.3 years. All 22 patients were successfully treated with radiofrequency ablation (RFA) of additional pathways. RFA effectiveness was evaluated with the help of clinical questionnaire, data of ECG, EchoCG, heart rate variability (HRV), frequency response and nonlinear dynamics. Cardiac rhythm disturbances were verified using Holter monitoring applied to all patients. Positive clinical effect was achieved in all the WPW patients, as RFA arrested cardiac arrhythmias completely. Holter monitoring did not register cardiac disturbances which points to high RFA effectiveness in WPW patients. HRV, frequency response and nonlinear dynamics reassumed their normal patterns.

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Hand

PubMed Central

Donofrio, Lisa; Hardas, Bhushan; Murphy, Diane K.; Carruthers, Jean; Carruthers, Alastair; Sykes, Jonathan M.; Creutz, Lela; Marx, Ann; Dill, Sara

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real-subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99–1.26] for clinically different image pairs and 0.45 [0.33–0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit. PMID:27661741

Development and Validation of a Photonumeric Scale for Evaluation of Facial Skin Texture

PubMed Central

Carruthers, Alastair; Hardas, Bhushan; Murphy, Diane K.; Carruthers, Jean; Jones, Derek; Sykes, Jonathan M.; Creutz, Lela; Marx, Ann; Dill, Sara

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96–1.23] for clinically different image pairs and 0.53 [0.38–0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness. PMID:27661744

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.

Development and Validation of a Photonumeric Scale for Evaluation of Volume Deficit of the Temple

PubMed Central

Jones, Derek; Hardas, Bhushan; Murphy, Diane K.; Donofrio, Lisa; Sykes, Jonathan M.; Carruthers, Alastair; Creutz, Lela; Marx, Ann; Dill, Sara

2016-01-01

BACKGROUND A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale. METHODS The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94–1.26] for clinically different image pairs and 0.67 [0.51–0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit. PMID:27661742

Description of interventions is under-reported in physical therapy clinical trials.

PubMed

Hariohm, K; Jeyanthi, S; Kumar, J Saravan; Prakash, V

Amongst several barriers to the application of quality clinical evidence and clinical guidelines into routine daily practice, poor description of interventions reported in clinical trials has received less attention. Although some studies have investigated the completeness of descriptions of non-pharmacological interventions in randomized trials, studies that exclusively analyzed physical therapy interventions reported in published trials are scarce. To evaluate the quality of descriptions of interventions in both experimental and control groups in randomized controlled trials published in four core physical therapy journals. We included all randomized controlled trials published from the Physical Therapy Journal, Journal of Physiotherapy, Clinical Rehabilitation, and Archives of Physical Medicine and Rehabilitation between June 2012 and December 2013. Each randomized controlled trial (RCT) was analyzed and coded for description of interventions using the checklist developed by Schroter et al. Out of 100 RCTs selected, only 35 RCTs (35%) fully described the interventions in both the intervention and control groups. Control group interventions were poorly described in the remaining RCTs (65%). Interventions, especially in the control group, are poorly described in the clinical trials published in leading physical therapy journals. A complete description of the intervention in a published report is crucial for physical therapists to be able to use the intervention in clinical practice. Copyright © 2017 Associação Brasileira de Pesquisa e Pós-Graduação em Fisioterapia. Publicado por Elsevier Editora Ltda. All rights reserved.

Laxity after complete release of the medial collateral ligament in primary total knee arthroplasty.

PubMed

Cho, Woo-Shin; Byun, Seong-Eun; Lee, Sang-Jun; Yoon, Jaeyoun

2015-06-01

Medial collateral ligament (MCL) release is one of the essential steps toward the achievement of ligament balancing during the total knee arthroplasty (TKA) in patients with varus deformity. When the varus deformity is severe, complete release of the MCL until balanced is often required. However, it is believed that complete MCL release may lead to catastrophic laxity. The purpose of this prospective study is to compare the medial joint gap opening in postoperative valgus stress radiograph in patients with complete MCL release against patients with partial release. Out of 209 primary TKAs performed for degenerative osteoarthritis, complete MCL release was required in 33 cases (group I) by sub-periosteal detachment at proximal tibia using periosteal elevator. For the remaining 176 knees (group II), partial release of MCL was done. At postoperative 6 months and 1 year, both groups were evaluated for comparing the joint gap on valgus stress radiographs using modified Telos device in 0°, 45°, and 90° of flexion. Additional parameters which were analyzed included preoperative varus and valgus stress radiographs in full extension and pre- and postoperative mechanical alignment in each group. The knee range of motion (ROM) and clinical scores were evaluated at 1-year follow-up. The mean values of the joint opening on the postoperative valgus stress test with the knee joint extended, and in the 45° and 90° flexed states at 6 months and at 1 year postoperatively in group I were not statistically significantly different from those of group II. The clinical scores also did not show a statistically significant difference between two groups. There was a statistically significant difference in ROM between two groups, pre- and postoperatively and the difference was 5°, respectively. This study suggests that complete MCL release for ligament balancing is a safe procedure and does not lead to postoperative laxity.

Treatment of Selective Mutism: Applications in the Clinic and School through Conjoint Consultation

ERIC Educational Resources Information Center

Mitchell, Angela D.; Kratochwill, Thomas R.

2013-01-01

The purpose of this study was to evaluate the effectiveness of a psychosocial approach to the treatment of Selective Mutism (SM). Four children with SM along with their parents and teachers participated in the study. A comprehensive assessment was completed; manualized treatment was implemented through a conjoint behavioral consultation approach,…

Dissemination Strategies: The Evolution of Learning Resources on the Evaluation of Delirium, Dementia, and Depression

ERIC Educational Resources Information Center

Horvath, Kathy J.; Tumosa, Nina; Thielke, Stephen; Moorer, Julie; Huh, Terri; Cooley, Susan; Craft, Suzanne; Burns, Theressa

2011-01-01

Clinicians experience great pressures to provide timely, effective, and evidence-based medical care. Educators can aid these clinicians through the development of new tools that can facilitate timely completion of clinical tasks. These tools should summarize evidence-based information in a convenient format that allows easy use. This article…

Evaluation of bivalent Newcastle disease virus (NDV) vectored infectious laryngotracheitis vaccines in broiler chickens in the presence of NDV maternally derived antibody

USDA-ARS?s Scientific Manuscript database

Previously we have demonstrated that Newcastle disease virus (NDV) recombinants expressing the infectious laryngotracheitis virus (ILTV) glycoproteins B (gB) or D (gD) protein conferred complete clinical protection against ILTV and NDV challenges in specific pathogen free (SPF) and 3 week old commer...

Properties of the Narrative Scoring Scheme Using Narrative Retells in Young School-Age Children

ERIC Educational Resources Information Center

Heilmann, John; Miller, Jon F.; Nockerts, Ann; Dunaway, Claudia

2010-01-01

Purpose: To evaluate the clinical utility of the narrative scoring scheme (NSS) as an index of narrative macrostructure for young school-age children. Method: Oral retells of a wordless picture book were elicited from 129 typically developing children, ages 5-7. A series of correlations and hierarchical regression equations were completed using…

Comparative Study of Children with ADHD Only, Autism Spectrum Disorder + ADHD, and Chronic Multiple Tic Disorder + ADHD

ERIC Educational Resources Information Center

Gadow, Kenneth D.; DeVincent, Carla J.; Schneider, Jayne

2009-01-01

Objective: Identification of differences among children with ADHD only, autism spectrum disorder (ASD)+ADHD, and chronic multiple tic disorder (CMTD)+ADHD may lead to better understanding of clinical phenotypes. Method: Children were evaluated using the parent- and teacher-completed questionnaires. Results: All three groups were highly similar in…

CONSORT to community: translation of an RCT to a large-scale community intervention and learnings from evaluation of the upscaled program.

PubMed

Moores, Carly Jane; Miller, Jacqueline; Perry, Rebecca Anne; Chan, Lily Lai Hang; Daniels, Lynne Allison; Vidgen, Helen Anna; Magarey, Anthea Margaret

2017-11-29

Translation encompasses the continuum from clinical efficacy to widespread adoption within the healthcare service and ultimately routine clinical practice. The Parenting, Eating and Activity for Child Health (PEACH™) program has previously demonstrated clinical effectiveness in the management of child obesity, and has been recently implemented as a large-scale community intervention in Queensland, Australia. This paper aims to describe the translation of the evaluation framework from a randomised controlled trial (RCT) to large-scale community intervention (PEACH™ QLD). Tensions between RCT paradigm and implementation research will be discussed along with lived evaluation challenges, responses to overcome these, and key learnings for future evaluation conducted at scale. The translation of evaluation from PEACH™ RCT to the large-scale community intervention PEACH™ QLD is described. While the CONSORT Statement was used to report findings from two previous RCTs, the REAIM framework was more suitable for the evaluation of upscaled delivery of the PEACH™ program. Evaluation of PEACH™ QLD was undertaken during the project delivery period from 2013 to 2016. Experiential learnings from conducting the evaluation of PEACH™ QLD to the described evaluation framework are presented for the purposes of informing the future evaluation of upscaled programs. Evaluation changes in response to real-time changes in the delivery of the PEACH™ QLD Project were necessary at stages during the project term. Key evaluation challenges encountered included the collection of complete evaluation data from a diverse and geographically dispersed workforce and the systematic collection of process evaluation data in real time to support program changes during the project. Evaluation of large-scale community interventions in the real world is challenging and divergent from RCTs which are rigourously evaluated within a more tightly-controlled clinical research setting. Constructs explored in an RCT are inadequate in describing the enablers and barriers of upscaled community program implementation. Methods for data collection, analysis and reporting also require consideration. We present a number of experiential reflections and suggestions for the successful evaluation of future upscaled community programs which are scarcely reported in the literature. PEACH™ QLD was retrospectively registered with the Australian New Zealand Clinical Trials Registry on 28 February 2017 (ACTRN12617000315314).

The Challenges of Data Quality Evaluation in a Joint Data Warehouse

PubMed Central

Bae, Charles J.; Griffith, Sandra; Fan, Youran; Dunphy, Cheryl; Thompson, Nicolas; Urchek, John; Parchman, Alandra; Katzan, Irene L.

2015-01-01

Introduction: The use of clinically derived data from electronic health records (EHRs) and other electronic clinical systems can greatly facilitate clinical research as well as operational and quality initiatives. One approach for making these data available is to incorporate data from different sources into a joint data warehouse. When using such a data warehouse, it is important to understand the quality of the data. The primary objective of this study was to determine the completeness and concordance of common types of clinical data available in the Knowledge Program (KP) joint data warehouse, which contains feeds from several electronic systems including the EHR. Methods: A manual review was performed of specific data elements for 250 patients from an EHR, and these were compared with corresponding elements in the KP data warehouse. Completeness and concordance were calculated for five categories of data including demographics, vital signs, laboratory results, diagnoses, and medications. Results: In general, data elements for demographics, vital signs, diagnoses, and laboratory results were present in more cases in the source EHR compared to the KP. When data elements were available in both sources, there was a high concordance. In contrast, the KP data warehouse documented a higher prevalence of deaths and medications compared to the EHR. Discussion: Several factors contributed to the discrepancies between data in the KP and the EHR—including the start date and frequency of data feeds updates into the KP, inability to transfer data located in nonstructured formats (e.g., free text or scanned documents), as well as incomplete and missing data variables in the source EHR. Conclusion: When evaluating the quality of a data warehouse with multiple data sources, assessing completeness and concordance between data set and source data may be better than designating one to be a gold standard. This will allow the user to optimize the method and timing of data transfer in order to capture data with better accuracy. PMID:26290882

Increasing colonoscopy screening in disparate populations: Results from an evaluation of patient navigation in the New Hampshire Colorectal Cancer Screening Program.

PubMed

Rice, Ketra; Gressard, Lindsay; DeGroff, Amy; Gersten, Joanne; Robie, Janene; Leadbetter, Steven; Glover-Kudon, Rebecca; Butterly, Lynn

2017-09-01

To investigate uniformly successful results from a statewide program of patient navigation (PN) for colonoscopy, this comparison study evaluated the effectiveness of the PN intervention by comparing outcomes for navigated versus non-navigated patients in one of the community health clinics included in the statewide program. Outcomes measured included screening completion, adequacy of bowel preparation, missed appointments and cancellations, communication of test results, and consistency of follow-up recommendations with clinical guidelines. The authors compared a subset of 131 patients who were navigated to a screening or surveillance colonoscopy with a similar subset of 75 non-navigated patients at one endoscopy clinic. The prevalence and prevalence odds ratios were computed to measure the association between PN and each study outcome measure. Patients in the PN intervention group were 11.2 times more likely to complete colonoscopy than control patients (96.2% vs 69.3%; P<.001), and were 5.9 times more likely to have adequate bowel preparation (P =.010). In addition, intervention patients had no missed appointments compared with 15.6% of control patients, and were 24.8 times more likely to not have a cancellation <24 hours before their appointment (P<.001). All navigated patients and their primary care providers received test results, and all follow-up recommendations were consistent with clinical guidelines compared with 82.4% of patients in the control group (P<.001). PN appears to be effective for improving colonoscopy screening completion and quality in the disparate populations most in need of intervention. To the best of our knowledge, the results of the current study demonstrate some of the strongest evidence for the effectiveness of PN to date, and highlight its value for public health. Cancer 2017;123:3356-66. © 2017 American Cancer Society. © 2017 American Cancer Society.

Relationships between thermal dose parameters and the efficacy of definitive chemoradiotherapy plus regional hyperthermia in the treatment of locally advanced cervical cancer: data from a multicentre randomised clinical trial.

PubMed

Ohguri, Takayuki; Harima, Yoko; Imada, Hajime; Sakurai, Hideyuki; Ohno, Tatsuya; Hiraki, Yoshiyuki; Tuji, Koh; Tanaka, Masahiro; Terashima, Hiromi

2018-06-01

To evaluate the contribution of the thermal dose parameters during regional hyperthermia (HT) treatment to the clinical outcomes in patients with cervical carcinoma (CC) who received chemoradiotherapy (CRT) plus HT. Data from a multicentre randomised clinical trial of concurrent CRT + HT vs. CRT alone were used to evaluate the efficacy and safety of this combination therapy in the CC patients. The intrarectal temperatures of patients undergoing HT were recorded. The complete thermal data of 47 (92%) of the 51 patients in the CRT + HT group were available for the thermal analysis. Thus, 47 patients who received CRT + HT were included in the present study. Among the patients who received CRT + HT, a higher CEM43T90 (≥1 min) value (a thermal dose parameter) was significantly associated with better local relapse-free survival in both univariate (p = 0.024) and multivariate (p = 0.0097) analyses. The disease-free survival of the patients with higher CEM43T90 (≥1 min) values tended to be better in comparison to patients with lower CEM43T90 (<1 min) value (p = 0.071). A complete response tended to be associated with the CEM43T90 (p = 0.056). Disease-free survival, local relapse-free survival and complete response rate for patients with higher CEM43T90 (≥1) were significantly better than those for patients with CRT alone (p = 0.036, p = 0.036 and p = 0.048). Dose-effect relationships between thermal dose parameters and clinical outcomes were confirmed in the CC patients treated with a combination of CRT + HT. This study also confirmed that HT with lower CEM43T90 is insufficient to achieve a significant hyperthermic sensitisation to CRT.

Review of systems, physical examination, and routine tests for case-finding in ambulatory patients.

PubMed

Boland, B J; Wollan, P C; Silverstein, M D

1995-04-01

The screening value of the comprehensive review of systems and the complete physical examination in detecting unsuspected diseases for which therapeutic interventions are initiated has not been formally studied in ambulatory patients. The medical records of 100 randomly selected adult patients who had an ambulatory general medical evaluation at the Mayo Clinic in 1990-1991 were surveyed to compare review of systems and physical examination with routine laboratory tests, chest radiography, and electrocardiography as case-finding maneuvers. The main outcome measure was the therapeutic yield of each case-finding maneuver, defined as the proportion of maneuvers leading to a new therapy for a new clinically important diagnosis. The utilization rate of routine tests in the 100 patients (mean age: 59 +/- 16 years; 58% women) was high, ranging from 77 to 98%. Overall, the case-finding maneuvers led to 36 unsuspected clinically important diagnoses and resulted in 25 new therapeutic interventions. Higher therapeutic yield was observed for review of systems (7%), physical examination (5%), and lipid screening (9.2%) than for chemistry group (2.2%), complete blood count (1.8%), thyroid tests (1.5%), urinalysis (1.1%), electrocardiography (0%), or chest radiography (0%). The number of therapeutic interventions was not associated with patient's age (P = 0.55), sex (P = 0.88), comorbidity (P = 0.30) or with the time interval since the last general medical evaluation (P = 0.12). Based on therapeutic yield, these data suggest that review of systems and physical examination are valuable case-finding maneuvers in the periodic medical evaluation of ambulatory patients.

Radiotherapy of Langerhans' Cell Histiocytosis : Results and Implications of a National Patterns-of-Care Study.

PubMed

Olschewski, Thomas; Seegenschmiedt, Michael Heinrich

2006-11-01

This patterns-of-care study was performed to define the current clinical experience with radiotherapy of Langerhans' cell histiocytosis in adults in Germany and to define open questions resulting from this study. A standardized questionnaire was sent to 198 German radiotherapy institutions. Data about patient characteristics, stage of disease, practice and fractionation of radiotherapy, outcome of therapy, etc. were systematically evaluated. 123 of 198 institutions answered the complete questionnaire (62.1%). Only 23 of the 123 institutions (18.7%) reported experience with radiotherapy of Langerhans' cell histiocytosis of adults. 18 institutions with 98 patients were evaluable. The majority of patients (72 of 98) was treated on a linear accelerator. The median single dose of radiotherapy was 2 Gy, while the median total dose was 24 Gy. 81 of 89 evaluable patients (91%) reached a local control of the treated lesion(s), 69 of those had a complete remission. Eight of 89 patients (9%) developed an in-field recurrence. 87.8% of patients experienced no acute and 97% of patients no late side effects of radiotherapy. Clinical experience with radiotherapy of Langerhans' cell histiocytosis in adults in Germany is still very limited. Nevertheless, the clinical results-with high remission and local control rates-confirm the effectiveness of radiotherapy in the multidisciplinary treatment of this disease. Due to the small number of patients in this study despite higher incidence rates, the knowledge of this disease has to be multiplied in Germany. Future patients should be systematically included into a prospective radiotherapy registry.

Formal faculty observation and assessment of bedside skills for 3rd-year neurology clerks

PubMed Central

Mooney, Christopher; Wexler, Erika; Mink, Jonathan; Post, Jennifer; Jozefowicz, Ralph F.

2016-01-01

Objective: To evaluate the feasibility and utility of instituting a formalized bedside skills evaluation (BSE) for 3rd-year medical students on the neurology clerkship. Methods: A neurologic BSE was developed for 3rd-year neurology clerks at the University of Rochester for the 2012–2014 academic years. Faculty directly observed 189 students completing a full history and neurologic examination on real inpatients. Mock grades were calculated utilizing the BSE in the final grade, and number of students with a grade difference was determined when compared to true grade. Correlation was explored between the BSE and clinical scores, National Board of Medical Examiners (NBME) scores, case complexity, and true final grades. A survey was administered to students to assess their clinical skills exposure and the usefulness of the BSE. Results: Faculty completed and submitted a BSE form for 88.3% of students. There was a mock final grade change for 13.2% of students. Correlation coefficients between BSE score and clinical score/NBME score were 0.36 and 0.35, respectively. A statistically significant effect of BSE was found on final clerkship grade (F2,186 = 31.9, p < 0.0001). There was no statistical difference between BSE score and differing case complexities. Conclusions: Incorporating a formal faculty-observed BSE into the 3rd year neurology clerkship was feasible. Low correlation between BSE score and other evaluations indicated a unique measurement to contribute to student grade. Using real patients with differing case complexity did not alter the grade. PMID:27770072

Evaluation of the Effect of a Promotora-led Educational Intervention on Cervical Cancer and Human Papillomavirus Knowledge Among Predominantly Hispanic Primary Care Patients on the US-Mexico Border.

PubMed

Molokwu, Jennifer; Penaranda, Eribeth; Flores, Silvia; Shokar, Navkiran K

2016-12-01

Despite declining cervical cancer rates, ethnic minorities continue to bear an unequal burden in morbidity and mortality. While access to screening is a major barrier, low levels of knowledge and cultural influences have been found to play a part in underutilization of preventive services. The aim of our study was to evaluate the effect of a promontora-led educational intervention on cervical cancer and human papillomavirus knowledge in mainly Hispanic females attending a primary care clinic. One hundred ten females were recruited from the waiting room of a busy primary care clinic and invited to attend individual or small group educational sessions. Participants completed knowledge surveys pre- and post-intervention. An overall evaluation of the educational session was also completed. Following the educational intervention, participants showed an improvement in knowledge scores from a mean score of 10.8 (SD 3.43) out of a possible score of 18 to a mean score of 16.0 (SD1.51) (p < 0.001). 94.5 % of participants rated as excellent, the presentation of information in a way that was easy to understand, most reported that it was a good use of their time and that it lowered their anxiety about testing for early detection of cervical cancer. An educational intervention delivered by well-trained Promotora/Lay health care worker significantly improves patient's cervical cancer and HPV knowledge and can be a useful tool in patient education in the clinical setting especially with high risk populations.

Efficacy of interpersonal therapy-group format adapted to post-traumatic stress disorder: an open-label add-on trial.

PubMed

Campanini, Rosaly F B; Schoedl, Aline F; Pupo, Mariana C; Costa, Ana Clara H; Krupnick, Janice L; Mello, Marcelo F

2010-01-01

Post-traumatic stress disorder (PTSD) is a highly prevalent condition, yet available treatments demonstrate only modest efficacy. Exposure therapies, considered by many to be the "gold-standard" therapy for PTSD, are poorly tolerated by many patients and show high attrition. We evaluated interpersonal therapy, in a group format, adapted to PTSD (IPT-G PTSD), as an adjunctive treatment for patients who failed to respond to conventional psychopharmacological treatment. Research participants included 40 patients who sought treatment through a program on violence in the department of psychiatry of Federal University of São Paulo (UNIFESP). They had received conventional psychopharmacological treatment for at least 12 weeks and failed to have an adequate clinical response. After signing an informed consent, approved earlier by the UNIFESP Ethics Review Board, they received a semi-structured diagnostic interview (SCID-I), administered by a trained mental health worker, to confirm the presence of a PTSD diagnosis according to DSM-IV criteria. Other instruments were administered, and patients completed out self-report instruments at baseline, and endpoint to evaluate clinical outcomes. Thirty-three patients completed the trial, but all had at least one second outcome evaluation. There were significant improvements on all measures, with large effect sizes. IPT-G PTSD was effective not only in decreasing symptoms of PTSD, but also in decreasing symptoms of anxiety and depression. It led to significant improvements in social adjustment and quality of life. It was well tolerated and there were few dropouts. Our results are very preliminary; they need further confirmation through randomized controlled clinical trials.

Accrual and recruitment practices at Clinical and Translational Science Award (CTSA) institutions: a call for expectations, expertise, and evaluation.

PubMed

Kost, Rhonda G; Mervin-Blake, Sabrena; Hallarn, Rose; Rathmann, Charles; Kolb, H Robert; Himmelfarb, Cheryl Dennison; D'Agostino, Toni; Rubinstein, Eric P; Dozier, Ann M; Schuff, Kathryn G

2014-08-01

To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability. The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%-91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents' IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.

Formal faculty observation and assessment of bedside skills for 3rd-year neurology clerks.

PubMed

Thompson Stone, Robert; Mooney, Christopher; Wexler, Erika; Mink, Jonathan; Post, Jennifer; Jozefowicz, Ralph F

2016-11-22

To evaluate the feasibility and utility of instituting a formalized bedside skills evaluation (BSE) for 3rd-year medical students on the neurology clerkship. A neurologic BSE was developed for 3rd - year neurology clerks at the University of Rochester for the 2012-2014 academic years. Faculty directly observed 189 students completing a full history and neurologic examination on real inpatients. Mock grades were calculated utilizing the BSE in the final grade, and number of students with a grade difference was determined when compared to true grade. Correlation was explored between the BSE and clinical scores, National Board of Medical Examiners (NBME) scores, case complexity, and true final grades. A survey was administered to students to assess their clinical skills exposure and the usefulness of the BSE. Faculty completed and submitted a BSE form for 88.3% of students. There was a mock final grade change for 13.2% of students. Correlation coefficients between BSE score and clinical score/NBME score were 0.36 and 0.35, respectively. A statistically significant effect of BSE was found on final clerkship grade (F 2,186 = 31.9, p < 0.0001). There was no statistical difference between BSE score and differing case complexities. Incorporating a formal faculty-observed BSE into the 3rd year neurology clerkship was feasible. Low correlation between BSE score and other evaluations indicated a unique measurement to contribute to student grade. Using real patients with differing case complexity did not alter the grade. © 2016 American Academy of Neurology.

Accrual and Recruitment Practices at Clinical and Translational Science Award (CTSA) Institutions: A Call for Expectations, Expertise, and Evaluation

PubMed Central

Kost, Rhonda G.; Mervin-Blake, Sabrena; Hallarn, Rose; Rathmann, Charles; Kolb, H. Robert; Himmelfarb, Cheryl Dennison; D’Agostino, Toni; Rubinstein, Eric P.; Dozier, Ann M.; Schuff, Kathryn G.

2014-01-01

Purpose To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examine participant recruitment practices at Clinical and Translational Science Award sites (CTSAs) and make recommendations for performance metrics and accountability. Method The CTSA Recruitment and Retention taskforce developed and, in 2010, invited representatives at 46 CTSAs to complete an online 48-question survey querying CTSA accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. Results Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78–91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); their desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to IRB review (30%) or contract approval (22%). All respondents’ IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. Conclusions Many CTSAs lack the necessary framework to support study accrual. Recommendations to enhance accrual include articulating institutional expectations and policy for routine recruitment planning; providing recruitment expertise to inform feasibility assessment and recruitment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices. PMID:24826854

microRNAs as cancer therapeutics: A step closer to clinical application.

PubMed

Catela Ivkovic, Tina; Voss, Gjendine; Cornella, Helena; Ceder, Yvonne

2017-10-28

During the last decades, basic and translational research has enabled great improvements in the clinical management of cancer. However, scarcity of complete remission and many drug-induced toxicities are still a major problem in the clinics. Recently, microRNAs (miRNAs) have emerged as promising therapeutic targets due to their involvement in cancer development and progression. Their extraordinary regulatory potential, which enables regulation of entire signalling networks within the cells, makes them an interesting tool for the development of cancer therapeutics. In this review we will focus on miRNAs with experimentally proven therapeutic potential, and discuss recent advances in the technical development and clinical evaluation of miRNA-based therapeutic agents. Copyright © 2017 Elsevier B.V. All rights reserved.

First BNCT treatment of a skin melanoma in Argentina: dosimetric analysis and clinical outcome.

PubMed

González, S J; Bonomi, M R; Santa Cruz, G A; Blaumann, H R; Calzetta Larrieu, O A; Menéndez, P; Jiménez Rebagliati, R; Longhino, J; Feld, D B; Dagrosa, M A; Argerich, C; Castiglia, S G; Batistoni, D A; Liberman, S J; Roth, B M C

2004-11-01

A Phase I/II protocol for treating cutaneuos melanomas with BNCT was designed in Argentina by the Comisión Nacional de Energía Atómica and the medical center Instituto Roffo. The first of a cohort of thirty planned patients was treated on October 9, 2003. This article depicts the protocol-based procedure and describes the first clinical case, treatment regime and planning, patient irradiation, retrospective dosimetric analysis and clinical outcome. Considering the low acute skin toxicity and the complete response in 21 of the 25 subcutaneous melanoma nodules treated, a second irradiation was performed in a different location of the extremity of the same patient. The corresponding clinical outcome is still under evaluation.

Improving critical thinking and clinical reasoning with a continuing education course.

PubMed

Cruz, Dina Monteiro; Pimenta, Cibele Mattos; Lunney, Margaret

2009-03-01

Continuing education courses related to critical thinking and clinical reasoning are needed to improve the accuracy of diagnosis. This study evaluated a 4-day, 16-hour continuing education course conducted in Brazil.Thirty-nine nurses completed a pretest and a posttest consisting of two written case studies designed to measure the accuracy of nurses' diagnoses. There were significant differences in accuracy from pretest to posttest for case 1 (p = .008) and case 2 (p = .042) and overall (p = .001). Continuing education courses should be implemented to improve the accuracy of nurses' diagnoses.

The Relationship Between Levels of Fidelity in Simulation, Traditional Clinical Experiences and Objectives.

PubMed

Gore, Teresa

2017-06-15

The purpose of this study was to explore the relationship of baccalaureate nursing students' (BSN) perceived learning effectiveness using the Clinical Learning Environments Comparison Survey of different levels of fidelity simulation and traditional clinical experiences. A convenience sample of 103 first semester BSN enrolled in a fundamental/assessment clinical course and 155 fifth semester BSN enrolled in a leadership clinical course participated in this study. A descriptive correlational design was used for this cross-sectional study to evaluate students' perceptions after a simulation experience and the completion of the traditional clinical experiences. The subscales measured were communication, nursing leadership, and teaching-learning dyad. No statistical differences were noted based on the learning objectives. The communication subscale showed a tendency toward preference for traditional clinical experiences in meeting students perceived learning for communication. For student perceived learning effectiveness, faculty should determine the appropriate level of fidelity in simulation based on the learning objectives.

The incorporation of focused history in checklist for early recognition and treatment of acute illness and injury.

PubMed

Jayaprakash, Namita; Ali, Rashid; Kashyap, Rahul; Bennett, Courtney; Kogan, Alexander; Gajic, Ognjen

2016-08-31

Diagnostic error and delay are critical impediments to the safety of critically ill patients. Checklist for early recognition and treatment of acute illness and injury (CERTAIN) has been developed as a tool that facilitates timely and error-free evaluation of critically ill patients. While the focused history is an essential part of the CERTAIN framework, it is not clear how best to choreograph this step in the process of evaluation and treatment of the acutely decompensating patient. An un-blinded crossover clinical simulation study was designed in which volunteer critical care clinicians (fellows and attendings) were randomly assigned to start with either obtaining a focused history choreographed in series (after) or in parallel to the primary survey. A focused history was obtained using the standardized SAMPLE model that is incorporated into American College of Trauma Life Support (ATLS) and Pediatric Advanced Life Support (PALS). Clinicians were asked to assess six acutely decompensating patients using pre - determined clinical scenarios (three in series choreography, three in parallel). Once the initial choreography was completed the clinician would crossover to the alternative choreography. The primary outcome was the cognitive burden assessed through the NASA task load index. Secondary outcome was time to completion of a focused history. A total of 84 simulated cases (42 in parallel, 42 in series) were tested on 14 clinicians. Both the overall cognitive load and time to completion improved with each successive practice scenario, however no difference was observed between the series versus parallel choreographies. The median (IQR) overall NASA TLX task load index for series was 39 (17 - 58) and for parallel 43 (27 - 52), p = 0.57. The median (IQR) time to completion of the tasks in series was 125 (112 - 158) seconds and in parallel 122 (108 - 158) seconds, p = 0.92. In this clinical simulation study assessing the incorporation of a focused history into the primary survey of a non-trauma critically ill patient, there was no difference in cognitive burden or time to task completion when using series choreography (after the exam) compared to parallel choreography (concurrent with the primary survey physical exam). However, with repetition of the task both overall task load and time to completion improved in each of the choreographies.

Impact of patient questionnaires on completeness of clinical information and identification of causes of pain during outpatient abdominopelvic CT interpretation.

PubMed

Doshi, Ankur M; Huang, Chenchan; Ginocchio, Luke; Shanbhogue, Krishna; Rosenkrantz, Andrew B

2017-12-01

To evaluate the impact of questionnaires completed by patients at the time of abdominopelvic CT performed for abdominal pain on the completeness of clinical information and the identification of potential causes of pain, compared with order requisitions alone. 100 outpatient CT examinations performed for the evaluation of abdominal pain were retrospectively reviewed. The specificity of the location of pain was compared between the order requisition and patient questionnaire. An abdominal imaging fellow (Reader 1) and abdominal radiologist (Reader 2) reviewed the examinations independently in two sessions 6 weeks apart (one with only the order requisition and one also with the questionnaire). Readers recorded identified causes of pain and rated their confidence in interpretation (1-5 scale; least to greatest confidence). In 30% of patients, the questionnaire provided a more specific location for pain. Among these, the pain was localized to a specific quadrant in 40%. With having access to the questionnaire, both readers identified additional causes for pain not identified in session 1 (Reader 1, 8.6% [7/81]; Reader 2 5.3% [4/75]). Additional identified causes of pain included diverticulitis, cystitis, peritoneal implants, epiploic appendagitis, osseous metastatic disease, umbilical hernia, gastritis, and SMA syndrome. Confidence in interpretation was significantly greater using the questionnaire for both readers (Reader 1: 4.8 ± 0.6 vs. 4.0 ± 0.5; Reader 2: 4.9 ± 0.3 vs. 4.7 ± 0.5, p < 0.001). Patient questionnaires provide additional relevant clinical history, increased diagnostic yield, and improve radiologists' confidence. Radiology practices are encouraged to implement questionnaires and make these readily available to radiologists at the time of interpretation.

Computer-generated vs. physician-documented history of present illness (HPI): results of a blinded comparison.

PubMed

Almario, Christopher V; Chey, William; Kaung, Aung; Whitman, Cynthia; Fuller, Garth; Reid, Mark; Nguyen, Ken; Bolus, Roger; Dennis, Buddy; Encarnacion, Rey; Martinez, Bibiana; Talley, Jennifer; Modi, Rushaba; Agarwal, Nikhil; Lee, Aaron; Kubomoto, Scott; Sharma, Gobind; Bolus, Sally; Chang, Lin; Spiegel, Brennan M R

2015-01-01

Healthcare delivery now mandates shorter visits with higher documentation requirements, undermining the patient-provider interaction. To improve clinic visit efficiency, we developed a patient-provider portal that systematically collects patient symptoms using a computer algorithm called Automated Evaluation of Gastrointestinal Symptoms (AEGIS). AEGIS also automatically "translates" the patient report into a full narrative history of present illness (HPI). We aimed to compare the quality of computer-generated vs. physician-documented HPIs. We performed a cross-sectional study with a paired sample design among individuals visiting outpatient adult gastrointestinal (GI) clinics for evaluation of active GI symptoms. Participants first underwent usual care and then subsequently completed AEGIS. Each individual thereby had both a physician-documented and a computer-generated HPI. Forty-eight blinded physicians assessed HPI quality across six domains using 5-point scales: (i) overall impression, (ii) thoroughness, (iii) usefulness, (iv) organization, (v) succinctness, and (vi) comprehensibility. We compared HPI scores within patient using a repeated measures model. Seventy-five patients had both computer-generated and physician-documented HPIs. The mean overall impression score for computer-generated HPIs was higher than physician HPIs (3.68 vs. 2.80; P<0.001), even after adjusting for physician and visit type, location, mode of transcription, and demographics. Computer-generated HPIs were also judged more complete (3.70 vs. 2.73; P<0.001), more useful (3.82 vs. 3.04; P<0.001), better organized (3.66 vs. 2.80; P<0.001), more succinct (3.55 vs. 3.17; P<0.001), and more comprehensible (3.66 vs. 2.97; P<0.001). Computer-generated HPIs were of higher overall quality, better organized, and more succinct, comprehensible, complete, and useful compared with HPIs written by physicians during usual care in GI clinics.

Diagnostic Testing and Interpretation of Tests for Autoimmunity

PubMed Central

Castro, Christine; Gourley, Mark

2010-01-01

Laboratory testing is of great value when evaluating a patient with a suspected autoimmune disease. The results can confirm a diagnosis, estimate disease severity, aid in assessing prognosis and are useful to follow disease activity. Components of the laboratory exam include complete blood count with differential, comprehensive metabolic panel, inflammatory markers, autoantibodies, and flow cytometry. This chapter discusses these components and includes a discussion about organ-specific immunologic diseases where immunological laboratory testing is employed. Comprehensive laboratory evaluation of a suspected autoimmune illness in conjunction with a thorough clinical evaluation provides a better understanding of a patient's immunologic disease. PMID:20061009

Developing and using a rubric for evaluating evidence-based medicine point-of-care tools

PubMed Central

Foster, Margaret J

2011-01-01

Objective: The research sought to establish a rubric for evaluating evidence-based medicine (EBM) point-of-care tools in a health sciences library. Methods: The authors searched the literature for EBM tool evaluations and found that most previous reviews were designed to evaluate the ability of an EBM tool to answer a clinical question. The researchers' goal was to develop and complete rubrics for assessing these tools based on criteria for a general evaluation of tools (reviewing content, search options, quality control, and grading) and criteria for an evaluation of clinical summaries (searching tools for treatments of common diagnoses and evaluating summaries for quality control). Results: Differences between EBM tools' options, content coverage, and usability were minimal. However, the products' methods for locating and grading evidence varied widely in transparency and process. Conclusions: As EBM tools are constantly updating and evolving, evaluation of these tools needs to be conducted frequently. Standards for evaluating EBM tools need to be established, with one method being the use of objective rubrics. In addition, EBM tools need to provide more information about authorship, reviewers, methods for evidence collection, and grading system employed. PMID:21753917

Factors that might be predictive of completion of vaginismus treatment.

PubMed

Özdel, Kadir; Yılmaz Özpolat, Ayşegül; Çeri, Özge; Kumbasar, Hakan

2012-01-01

Vaginismus is defined as a recurrent or persistent involuntary spasm of the musculature of the outer third of the vagina that interferes with sexual intercourse. The aim of this study was to assess the level of symptoms of depression, anxiety, obsessive-compulsive symptoms, and perfectionism among patients with vaginismus, as well as to determine if these clinical variables are related to the completion of treatment. The study included 20 women with vaginismus and their spouses that were referred as outpatients to Ankara University, School of Medicine, Department of Psychiatry, Consultation and Liaison Unit. All couples underwent cognitive behavioral therapy, which was administered as 40-60-min weekly sessions. At the first (assessment) session, the female patients were assessed using a sociodemographic evaluation form, the Hamilton Rating Scale for Depression (HAM-D), the Hamilton Rating Scale for Anxiety (HAM-A), the Maudsley Obsessive-Compulsive Inventory (MOCI), the Multidimensional Perfectionism Scale (MPS), and the Golombok Rust Inventory of Sexual Satisfaction (GRISS). The male spouses were evaluated using the GRISS. The same scales were administered after the completion of treatment to those that completed the treatment. The correlation between completion of treatment, and an elevated level of anxiety and self-oriented perfectionism was significant (P < 0.05). Among those that completed the study, depressive symptoms in the female patients improved (P< 0.05), and scale scores related to sexual functioning in both the males and females improved significantly (P < 0.05). Vaginismus is not only a sexual dysfunction, but it is related to multiple components of mental health. Anxiety and a perfectionist personality trait were important factors associated with the completion of treatment; therefore, these factors should be evaluated before treatment.

Laboratory Exercises to Teach Clinically Relevant Chemistry of Antibiotics

PubMed Central

Chelette, Candace T.

2014-01-01

Objectives. To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. Design. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. Assessment. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with <25% of students who had not completed the laboratory exercises. Conclusion. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students’ performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises. PMID:24672070

Laboratory exercises to teach clinically relevant chemistry of antibiotics.

PubMed

El Sayed, Khalid A; Chelette, Candace T

2014-03-12

To design, implement, and evaluate student performance on clinically relevant chemical and spectral laboratory exercises on antibiotics. In the first of 2 exercises, second-year pharmacy students enrolled in an integrated laboratory sequence course studied the aqueous stability of ß-lactam antibiotics using a spectral visual approach. In a second exercise, students studied the tendency of tetracycline, rifamycins, and fluoroquinolones to form insoluble chelate complexes (turbidity) with polyvalent metals. On a survey to assess achievement of class learning objectives, students agreed the laboratory activities helped them better retain important information concerning antibiotic stability and interactions. A significant improvement was observed in performance on examination questions related to the laboratory topics for 2012 and 2013 students compared to 2011 students who did not complete the laboratory. A 1-year follow-up examination question administered in a separate course showed >75% of the students were able to identify rifamycins-food interactions compared with <25% of students who had not completed the laboratory exercises. The use of spectral visual approaches allowed students to investigate antibiotic stability and interactions, thus reinforcing the clinical relevance of medicinal chemistry. Students' performance on questions at the 1-year follow-up suggested increased retention of the concepts learned as a result of completing the exercises.

A standard-driven approach for electronic submission to pharmaceutical regulatory authorities.

PubMed

Lin, Ching-Heng; Chou, Hsin-I; Yang, Ueng-Cheng

2018-03-01

Using standards is not only useful for data interchange during the process of a clinical trial, but also useful for analyzing data in a review process. Any step, which speeds up approval of new drugs, may benefit patients. As a result, adopting standards for regulatory submission becomes mandatory in some countries. However, preparing standard-compliant documents, such as annotated case report form (aCRF), needs a great deal of knowledge and experience. The process is complex and labor-intensive. Therefore, there is a need to use information technology to facilitate this process. Instead of standardizing data after the completion of a clinical trial, this study proposed a standard-driven approach. This approach was achieved by implementing a computer-assisted "standard-driven pipeline (SDP)" in an existing clinical data management system. SDP used CDISC standards to drive all processes of a clinical trial, such as the design, data acquisition, tabulation, etc. RESULTS: A completed phase I/II trial was used to prove the concept and to evaluate the effects of this approach. By using the CDISC-compliant question library, aCRFs were generated automatically when the eCRFs were completed. For comparison purpose, the data collection process was simulated and the collected data was transformed by the SDP. This new approach reduced the missing data fields from sixty-two to eight and the controlled term mismatch field reduced from eight to zero during data tabulation. This standard-driven approach accelerated CRF annotation and assured data tabulation integrity. The benefits of this approach include an improvement in the use of standards during the clinical trial and a reduction in missing and unexpected data during tabulation. The standard-driven approach is an advanced design idea that can be used for future clinical information system development. Copyright © 2018 Elsevier Inc. All rights reserved.

Treatment outcomes of intracranial dural arteriovenous fistulas of the transverse and sigmoid sinuses from a single institute in Asia.

PubMed

Cho, Won-Sang; Han, Jung Ho; Kang, Hyun-Seung; Kim, Jeong Eun; Kwon, O-Ki; Oh, Chang Wan; Han, Moon Hee; Chung, Young Seob

2013-07-01

Intracranial dural arteriovenous fistulas (DAVFs) of the transverse and sigmoid sinuses (TSS) are rare in Asian populations. This study sought to evaluate the treatment outcomes of intracranial TSS DAVFs at a single Asian institute. Between 1989 and 2007, 122 patients presented to the Seoul National University Hospital with intracranial DAVFs; we performed a retrospective analysis of the 38 patients (31.1%) with TSS DAVFs. The common clinical presentations were headache (44.7%), tinnitus (39.5%), and intracranial hemorrhage (26.3%), and 71.1% had Borden type II or III lesions. Two patients were conservatively managed, two underwent surgery, and 34 were treated endovascularly with transarterial embolization (TAE), transvenous embolization (TVE), or both. The complete occlusion rate immediately after treatment was 50%. Of the 31 patients (81.6%) who underwent follow-up angiography, initial complete occlusion was achieved in 51.6%, and, at the last follow-up, the complete occlusion rate was 64.5%, with the surgery and TVE groups achieving 100% occlusion. The clinical cure rate was 34.2%, and 86.8% of patients had a favorable clinical outcome. However, all patients in both the surgery and TVE groups achieved a favorable clinical outcome. Four (26.7%) of 15 lesions with initially partial embolization showed delayed occlusion. Five patients (13.2%) exhibited clinical or angiographic signs of recurrence, and five patients had permanent complications. TSS DAVFs were less common than cavernous sinus DAVFs, unlike in Western countries, but the angiographic and clinical characteristics of TSS DAVFs were similar to those in Western countries. TSS DAVFs were successfully managed with different modalities, but both surgery and TVE were superior to conservative management or TAE. Copyright © 2012 Elsevier Ltd. All rights reserved.

My personal experiences at the BEST Medical Center: A day in the clinic-the morning.

PubMed

Cohen, Philip R; Kurzrock, Razelle

2016-01-01

Dr. Ida Lystic is a gastroenterologist who trained at the OTHER (Owen T. Henry and Eugene Rutherford) Medical Center, after having completed her MD degree at the prestigious Harvey Medical School (recently renamed the Harvey Provider School). She accepted a faculty position at the BEST (Byron Edwards and Samuel Thompson) Medical Center. Dr. Lystic shares her experiences on a typical morning in gastroenterology clinic. Although her clinic start date was delayed by 2 months after becoming sick following a mandatory flu shot and having to complete more than 70 hours of compliance training modules, she is now familiar with the BEST system. Clinic scheduling priorities include ensuring that the staff can eat lunch together and depart at 5:00 pm. It is a continual challenge to find time to complete the electronic medical record after BEST changed from the SIMPLE (Succinct Input Making Patients Lives Electronic) system to LEGEND (referred to as Lengthy and Excessively Graded Evaluation and Nomenclature for Diagnosis by her colleagues). To maintain clinic punctuality, a compliance spreadsheet is e-mailed monthly to the Wait Time Committee. Their most recent corrective action plan for tardy physicians included placing egg timers on the doors and having nurses interrupt visits that exceed the allotted time. Administrative decisions have resulted in downsizing personnel. Patients are required to schedule their own tests and procedures and follow-up appointments-causing low patient satisfaction scores; however, the money saved lead to a large year-end bonus for the vice president of BEST Efficiency, who holds "providers" accountable for the poor patient experience. Although Dr. Ida Lystic and the gastroenterology clinic at "the BEST Medical Center" are creations of the authors' imagination, the majority of the anecdotes are based on actual events. Copyright © 2016 Elsevier Inc. All rights reserved.

Comparison of reporting phase III randomized controlled trials of antibiotic treatment for common bacterial infections in ClinicalTrials.gov and matched publications.

PubMed

Shepshelovich, D; Yelin, D; Gafter-Gvili, A; Goldman, S; Avni, T; Yahav, D

2018-02-15

Discrepancies between ClinicalTrials.gov entries and matching publications were previously described in general medicine. We aimed to evaluate the consistency of reporting in trials addressing systemic antibiotic therapy. We searched ClinicalTrials.gov for completed phase III trials comparing antibiotic regimens until May 2017. Matched publications were identified in PubMed. Two independent reviewers extracted data and identified inconsistencies. Reporting was assessed among studies started before and after 1 July 2005, when the International Committee of Medical Journal Editors (ICMJE) required mandatory registration as a prerequisite for considering a trial for publication. Matching publications were identified for 75 (70%) of 107 ClinicalTrials.gov entries. Median time from study completion to publication was 26 months (interquartile range 19-42). Primary outcome definition was inconsistent between ClinicalTrials.gov and publications in seven trials (7/72, 10%) and reporting of the primary outcome timeframe was inconsistent in 14 (14/71, 20%). Secondary outcomes definitions were inconsistent in 36 trials (36/66, 55%). Reporting of inclusion criteria and study timeline were inconsistent in 17% (13/65) and 3% (2/65), respectively. Trials started after July 2005 were significantly less likely to have reporting inconsistencies and were published in higher impact factor journals. We found a lower inconsistency rate of outcome reporting compared with other medical disciplines. Reporting completeness and consistency were significantly better after July 2005. The ICMJE requirement for mandatory registration was associated with significant improvement in reporting quality in infectious diseases trials. Prolonged time lag to publication and missing data from unpublished trials should raise a discussion on current reporting and publishing procedures. Copyright © 2018 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

Implementation of the Kids-CAT in clinical settings: a newly developed computer-adaptive test to facilitate the assessment of patient-reported outcomes of children and adolescents in clinical practice in Germany.

PubMed

Barthel, D; Fischer, K I; Nolte, S; Otto, C; Meyrose, A-K; Reisinger, S; Dabs, M; Thyen, U; Klein, M; Muehlan, H; Ankermann, T; Walter, O; Rose, M; Ravens-Sieberer, U

2016-03-01

To describe the implementation process of a computer-adaptive test (CAT) for measuring health-related quality of life (HRQoL) of children and adolescents in two pediatric clinics in Germany. The study focuses on the feasibility and user experience with the Kids-CAT, particularly the patients' experience with the tool and the pediatricians' experience with the Kids-CAT Report. The Kids-CAT was completed by 312 children and adolescents with asthma, diabetes or rheumatoid arthritis. The test was applied during four clinical visits over a 1-year period. A feedback report with the test results was made available to the pediatricians. To assess both feasibility and acceptability, a multimethod research design was used. To assess the patients' experience with the tool, the children and adolescents completed a questionnaire. To assess the clinicians' experience, two focus groups were conducted with eight pediatricians. The children and adolescents indicated that the Kids-CAT was easy to complete. All pediatricians reported that the Kids-CAT was straightforward and easy to understand and integrate into clinical practice; they also expressed that routine implementation of the tool would be desirable and that the report was a valuable source of information, facilitating the assessment of self-reported HRQoL of their patients. The Kids-CAT was considered an efficient and valuable tool for assessing HRQoL in children and adolescents. The Kids-CAT Report promises to be a useful adjunct to standard clinical care with the potential to improve patient-physician communication, enabling pediatricians to evaluate and monitor their young patients' self-reported HRQoL.

Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data

PubMed Central

Wieseler, Beate; Wolfram, Natalia; McGauran, Natalie; Kerekes, Michaela F.; Vervölgyi, Volker; Kohlepp, Petra; Kamphuis, Marloes; Grouven, Ulrich

2013-01-01

Background Access to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments. Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs. Methods and Findings We used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall. We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes. The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs. Conclusions In contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available. Please see later in the article for the Editors' Summary PMID:24115912

Clinical Simulation in Psychiatric-Mental Health Nursing: Post-Graduation Follow Up.

PubMed

Lilly, Mary LuAnne; Hermanns, Melinda; Crawley, Bill

2016-10-01

In psychiatric-mental health, creating an innovative strategy to help students learn content that may not be frequently seen in a clinical setting is challenging. Thus, simulation helps narrow this gap. Using Kirkpatrick and Kirkpatrick's model of evaluation to guide the current study, faculty contacted baccalaureate nursing program graduates who completed a psychiatric-mental health clinical simulation scenario featuring a hanging suicide and wrist cutting suicide attempt scenario in the "Behind the Door" series as part of the clinical component of their undergraduate psychiatric-mental health course. Eleven nurses responded to a survey regarding their post-graduate encounters with these types of clinical situations, and their perception of recall and application of knowledge and skills acquired during the simulation experience to the clinical situation. Nursing graduates' responses are expressed through three major themes: emotional, contextual/behavioral, and assessment outcomes. Data from the survey indicate that nursing graduates perceived the "Behind the Door" simulations as beneficial to nursing practice. This perception is important in evaluating knowledge transfer from a simulation experience as a student into application in nursing practice. [Journal of Psychosocial Nursing and Mental Health Services, 54(10), 40-45.]. Copyright 2016, SLACK Incorporated.

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

Effects of a Short Video-Based Resident-as-Teacher Training Toolkit on Resident Teaching.

PubMed

Ricciotti, Hope A; Freret, Taylor S; Aluko, Ashley; McKeon, Bri Anne; Haviland, Miriam J; Newman, Lori R

2017-10-01

To pilot a short video-based resident-as-teacher training toolkit and assess its effect on resident teaching skills in clinical settings. A video-based resident-as-teacher training toolkit was previously developed by educational experts at Beth Israel Deaconess Medical Center, Harvard Medical School. Residents were recruited from two academic hospitals, watched two videos from the toolkit ("Clinical Teaching Skills" and "Effective Clinical Supervision"), and completed an accompanying self-study guide. A novel assessment instrument for evaluating the effect of the toolkit on teaching was created through a modified Delphi process. Before and after the intervention, residents were observed leading a clinical teaching encounter and scored using the 15-item assessment instrument. The primary outcome of interest was the change in number of skills exhibited, which was assessed using the Wilcoxon signed-rank test. Twenty-eight residents from two academic hospitals were enrolled, and 20 (71%) completed all phases of the study. More than one third of residents who volunteered to participate reported no prior formal teacher training. After completing two training modules, residents demonstrated a significant increase in the median number of teaching skills exhibited in a clinical teaching encounter, from 7.5 (interquartile range 6.5-9.5) to 10.0 (interquartile range 9.0-11.5; P<.001). Of the 15 teaching skills assessed, there were significant improvements in asking for the learner's perspective (P=.01), providing feedback (P=.005), and encouraging questions (P=.046). Using a resident-as-teacher video-based toolkit was associated with improvements in teaching skills in residents from multiple specialties.

Exercise and reproductive dysfunction.

PubMed

Chen, E C; Brzyski, R G

1999-01-01

To provide an overview of our current understanding of exercise-induced reproductive dysfunction and an approach to its evaluation and management. A MEDLINE search was performed to review all articles with title words related to menstrual dysfunction, amenorrhea, oligomenorrhea, exercise, and athletic activities from 1966 to 1998. The pathophysiology, proposed mechanisms, clinical manifestations, evaluation, and management of exercise-associated reproductive dysfunction were compiled. Exercise-induced menstrual irregularity appears to be multifactorial in origin and remains a diagnosis of exclusion. The underlying mechanisms are mainly speculative. Clinical manifestations range from luteal phase deficiency to anovulation, amenorrhea, and even delayed menarche. Evaluation should include a thorough history and a complete physical plus pelvic examination. Most cases are reversible with dietary and exercise modifications. Hormonal replacement in cases of a prolonged hypoestrogenic state with evidence of increased bone loss is recommended, although the long-term consequences of prolonged hormonal deficiency are ill-defined.

Vestibular rehabilitation: clinical benefits to patients with Parkinson's disease.

PubMed

Zeigelboim, Bianca Simone; Klagenberg, Karlin Fabianne; Teive, Hélio A Ghizoni; Munhoz, Renato Puppi; Martins-Bassetto, Jackeline

2009-06-01

To evaluate the effectiveness of the vestibular rehabilitation (VR) exercises by means of an assessment before and after the application of the Brazilian version of the Dizziness Handicap Inventory (DHI) questionnaire. Twelve patients were studied, the following procedures were carried out: anamnesis, otorhinolaryngological and vestibular evaluation, and the application of the DHI before and after the VR. Clinically resting tremors and subjective postural instability were the motor complaints most frequently associated with complaints of vertigo in 12 cases (100%); in the vestibular exam, all the patients presented abnormalities, frequently from the uni and bilateral peripheral vestibular deficiency syndromes in 10 cases (83.3%); there was significant improvement in the physical, functional and emotional aspects of the DHI after the completion of the VR. The VR following the Cawthorne and Cooksey protocol were shown to be useful in managing subjective complaints of several aspects evaluated in this protocol.

Usability Evaluation of Clinical Guidelines on the Web Using Eye-Tracker.

PubMed

Khodambashi, Soudabeh; Gilstad, Heidi; Nytrø, Øystein

2016-01-01

Publishing clinical guidelines (GLs) on the web increases their accessibility. However, evaluating their usability and understanding how users interact with the websites has been neglected. In this study we used Tobii eye-tracker to analyse users' interaction with five commercial and public GL sites popular in Norway (four in Norwegian and one English of US origin (UpToDate)). We measured number of clicks and usage rate for search functions, task completion time, users' objective and perception of task success rate. We also measured learning effect for inexperienced users. We found a direct correlation between participant's satisfaction regarding website usability and the time spent, number of mouse clicks and use of search function to obtain the desired results. Our study showed that users' perceived success rate was not reliable and GL publishers should evaluate their website regarding presentation format, layout, navigation bar and search function.

Lysosome and HER3 (ErbB3) selective anticancer agent kahalalide F: semisynthetic modifications and antifungal lead-exploration studies.

PubMed

Shilabin, Abbas Gholipour; Kasanah, Noer; Wedge, David E; Hamann, Mark T

2007-09-06

Kahalalide F (1) shows remarkable antitumor activity against different carcinomas and has recently completed phase I clinical trials and is being evaluated in phase II clinical studies. The antifungal activity of this molecule has not been thoroughly investigated. In this report, we focused on acetylation and oxidation of the secondary alcohol of threonine, as well as reductive alkylation of the primary amine of ornithine, and each product was evaluated for improvements in antifungal activity. 1 and analogues do not exhibit antimalarial, antileishmania, or antibacterial activity; however, the antifungal activity against different strains of fungi was particularly significant. This series of compounds was highly active against Fusarium spp., which represents an opportunistic infection in humans and plants. The in vitro cytotoxicity for the new analogues of 1 was evaluated in the NCI 60 cell panel. Analogue 5 exhibited enhanced potency in several human cancer cell lines relative to 1.

Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial

PubMed Central

Lee, Myung Kyung

2018-01-01

Objectives This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. Methods The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Results Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. Conclusions The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums. PMID:29503755

Effects of Flipped Learning Using Online Materials in a Surgical Nursing Practicum: A Pilot Stratified Group-Randomized Trial.

PubMed

Lee, Myung Kyung; Park, Bu Kyung

2018-01-01

This study examined the effect of flipped learning in comparison to traditional learning in a surgical nursing practicum. The subjects of this study were 102 nursing students in their third year of university who were scheduled to complete a clinical nursing practicum in an operating room or surgical unit. Participants were randomly assigned to either a flipped learning group (n = 51) or a traditional learning group (n = 51) for the 1-week, 45-hour clinical nursing practicum. The flipped-learning group completed independent e-learning lessons on surgical nursing and received a brief orientation prior to the commencement of the practicum, while the traditional-learning group received a face-to-face orientation and on-site instruction. After the completion of the practicum, both groups completed a case study and a conference. The student's self-efficacy, self-leadership, and problem-solving skills in clinical practice were measured both before and after the one-week surgical nursing practicum. Participants' independent goal setting and evaluation of beliefs and assumptions for the subscales of self-leadership and problem-solving skills were compared for the flipped learning group and the traditional learning group. The results showed greater improvement on these indicators for the flipped learning group in comparison to the traditional learning group. The flipped learning method might offer more effective e-learning opportunities in terms of self-leadership and problem-solving than the traditional learning method in surgical nursing practicums.

PathoScope 2.0: a complete computational framework for strain identification in environmental or clinical sequencing samples

PubMed Central

2014-01-01

Background Recent innovations in sequencing technologies have provided researchers with the ability to rapidly characterize the microbial content of an environmental or clinical sample with unprecedented resolution. These approaches are producing a wealth of information that is providing novel insights into the microbial ecology of the environment and human health. However, these sequencing-based approaches produce large and complex datasets that require efficient and sensitive computational analysis workflows. Many recent tools for analyzing metagenomic-sequencing data have emerged, however, these approaches often suffer from issues of specificity, efficiency, and typically do not include a complete metagenomic analysis framework. Results We present PathoScope 2.0, a complete bioinformatics framework for rapidly and accurately quantifying the proportions of reads from individual microbial strains present in metagenomic sequencing data from environmental or clinical samples. The pipeline performs all necessary computational analysis steps; including reference genome library extraction and indexing, read quality control and alignment, strain identification, and summarization and annotation of results. We rigorously evaluated PathoScope 2.0 using simulated data and data from the 2011 outbreak of Shiga-toxigenic Escherichia coli O104:H4. Conclusions The results show that PathoScope 2.0 is a complete, highly sensitive, and efficient approach for metagenomic analysis that outperforms alternative approaches in scope, speed, and accuracy. The PathoScope 2.0 pipeline software is freely available for download at: http://sourceforge.net/projects/pathoscope/. PMID:25225611

Simulation-based education with mastery learning improves residents' lumbar puncture skills

PubMed Central

Cohen, Elaine R.; Caprio, Timothy; McGaghie, William C.; Simuni, Tanya; Wayne, Diane B.

2012-01-01

Objective: To evaluate the effect of simulation-based mastery learning (SBML) on internal medicine residents' lumbar puncture (LP) skills, assess neurology residents' acquired LP skills from traditional clinical education, and compare the results of SBML to traditional clinical education. Methods: This study was a pretest-posttest design with a comparison group. Fifty-eight postgraduate year (PGY) 1 internal medicine residents received an SBML intervention in LP. Residents completed a baseline skill assessment (pretest) using a 21-item LP checklist. After a 3-hour session featuring deliberate practice and feedback, residents completed a posttest and were expected to meet or exceed a minimum passing score (MPS) set by an expert panel. Simulator-trained residents' pretest and posttest scores were compared to assess the impact of the intervention. Thirty-six PGY2, 3, and 4 neurology residents from 3 medical centers completed the same simulated LP assessment without SBML. SBML posttest scores were compared to neurology residents' baseline scores. Results: PGY1 internal medicine residents improved from a mean of 46.3% to 95.7% after SBML (p < 0.001) and all met the MPS at final posttest. The performance of traditionally trained neurology residents was significantly lower than simulator-trained residents (mean 65.4%, p < 0.001) and only 6% met the MPS. Conclusions: Residents who completed SBML showed significant improvement in LP procedural skills. Few neurology residents were competent to perform a simulated LP despite clinical experience with the procedure. PMID:22675080

Evidence-based information-seeking skills of junior doctors entering the workforce: an evaluation of the impact of information literacy training during pre-clinical years.

PubMed

Cullen, Rowena; Clark, Megan; Esson, Rachel

2011-06-01

To investigate the extent to which junior doctors in their first clinical positions retained information literacy skills taught as part of their undergraduate education. Participants drawn from different training cohorts were interviewed about their recall of the instruction they had received, and their confidence in retrieving and evaluating information for clinical decision making. They completed a search based on a scenario related to their specialty. Their self-assessment of their competency in conducting and evaluating a search was compared with an evaluation of their skills by an experienced observer. Most participants recalled the training they received but had not retained high-level search skills, and lacked skills in identifying and applying best evidence. There was no apparent link between the type of training given and subsequent skill level. Those whose postgraduate education required these skills were more successful in retrieving and appraising information. Commitment to evidence-based medicine from clinicians at all levels in the profession is needed to increase the information seeking skills of clinicians entering the work force. © 2011 The authors. Health Information and Libraries Journal © 2011 Health Libraries Group.

The Correction of Myopia Evaluation Trial: lessons from the study design.

PubMed

Hyman, L; Gwiazda, J

2004-01-01

The Correction of Myopia Evaluation Trial (COMET), a multicentre clinical trial based in 4 schools of optometry in the United States, evaluated the effect of progressive addition lenses versus single vision lenses on myopia progression in an ethnically diverse group of 469 myopic children aged 6 to 11 years. Completion of the clinical trial phase of the study provides an opportunity to evaluate aspects of the study design that contribute to its success. This article describes aspects of the study design that were influential in ensuring the smooth conduct of COMET. These include a dedicated team of investigators, an organisational structure with strong leadership and an independent Co-ordinating Centre, regular communication among investigators, flexible and creative approaches to recruitment and retention, sensitivity to concerns for child safety and child participation, and methods for enhancing and monitoring data reliability. The experience with COMET has provided a number of valuable lessons for all aspects of the study design that should benefit the development and implementation of future clinical trials, particularly those done in similar populations of children. The use of a carefully designed protocol using standard methods by dedicated members of the study team is essential in ensuring achievement of the study aims.

Generation of clinical-grade human induced pluripotent stem cells in Xeno-free conditions.

PubMed

Wang, Juan; Hao, Jie; Bai, Donghui; Gu, Qi; Han, Weifang; Wang, Lei; Tan, Yuanqing; Li, Xia; Xue, Ke; Han, Pencheng; Liu, Zhengxin; Jia, Yundan; Wu, Jun; Liu, Lei; Wang, Liu; Li, Wei; Liu, Zhonghua; Zhou, Qi

2015-11-12

Human induced pluripotent stem cells (hiPSCs) are considered as one of the most promising seed cell sources in regenerative medicine. Now hiPSC-based clinical trials are underway. To ensure clinical safety, cells used in clinical trials or therapies should be generated under GMP conditions, and with Xeno-free culture media to avoid possible side effects like immune rejection that induced by the Xeno reagents. However, up to now there are no reports for hiPSC lines developed completely under GMP conditions using Xeno-free reagents. Clinical-grade human foreskin fibroblast (HFF) cells used as feeder cells and parental cells of the clinical-grade hiPSCs were isolated from human foreskin tissues and cultured in Xeno-free media. Clinical-grade hiPSCs were derived by integration-free Sendai virus-based reprogramming kit in Xeno-free pluriton™ reprogramming medium or X medium. Neural cells and cardiomyocytes differentiation were conducted following a series of spatial and temporal specific signals induction according to the corresponding lineage development signals. Biological safety evaluation of the clinical-grade HFF cells and hiPSCs were conducted following the guidance of the "Pharmacopoeia of the People's Republic of China, Edition 2010, Volume III". We have successfully derived several integration-free clinical-grade hiPSC lines under GMP-controlled conditions and with Xeno-free reagents culture media in line with the current guidance of international and national evaluation criteria. As for the source of hiPSCs and feeder cells, biological safety evaluation of the HFF cells have been strictly reviewed by the National Institutes for Food and Drug Control (NIFDC). The hiPSC lines are pluripotent and have passed the safety evaluation. Moreover, one of the randomly selected hiPSC lines was capable of differentiating into functional neural cells and cardiomyocytes in Xeno-free culture media. The clinical-grade hiPSC lines therefore could be valuable sources for future hiPSC-based clinical trials or therapies and for drug screening.

Quality of Life After Cardiac Surgery Based on the Minimal Clinically Important Difference Concept.

PubMed

Grand, Nathalie; Bouchet, Jean Baptiste; Zufferey, Paul; Beraud, Anne Marie; Awad, Sahar; Sandri, Fabricio; Campisi, Salvator; Fuzellier, Jean François; Molliex, Serge; Vola, Marco; Morel, Jerome

2018-03-23

Health-related quality of life (HRQOL) is an increasingly important issue in assessing the consequences of any surgical or medical intervention. Our study aimed to evaluate change in HRQOL 6 months after elective cardiac surgery and to identify specific predictors of poor HRQOL. In this prospective, single-center study, HRQOL was evaluated before and 6 months after surgery using the SF-36 questionnaire and its two components: the physical component summary (PCS) and the mental component summary (MCS). We distinguished patients with worsening of HRQOL according to the minimal clinically important difference. All consecutive adult patients undergoing cardiac surgery were included. 326 patients completed the preoperative and postoperative SF-36 questionnaires and 24 patients died before completing follow-up questionnaires. Based on the definition used, clinically significant deterioration of HRQOL was observed in 93 patients (26.6%) for PCS and 99 patients (28.2%) for MCS. Renal replacement for acute renal failure and mechanical ventilation for longer than 48 hours were independent risk factors for PCS and MCS worsening or death. Although our study showed overall improvement of QOL after cardiac surgery, over a quarter of the patients manifested deterioration of HRQOL at 6 months post-surgery. The findings from this study should help clinicians to inform patients about their likely postoperative functional status and quality of life. Copyright © 2018. Published by Elsevier Inc.

Vasovagal tonus index (VVTI) as an indirect assessment of remission status in canine multicentric lymphoma undergoing multi-drug chemotherapy.

PubMed

Pecceu, Evi; Stebbing, Brittainy; Martinez Pereira, Yolanda; Handel, Ian; Culshaw, Geoff; Hodgkiss-Geere, Hannah; Lawrence, Jessica

2017-12-01

Vasovagal tonus index (VVTI) is an indirect measure of heart rate variability and may serve as a marker of disease severity. Higher heart rate variability has predicted lower tumour burden and improved survival in humans with various tumour types. The purpose of this pilot study was to evaluate VVTI as a biomarker of remission status in canine lymphoma. The primary hypothesis was that VVTI would be increased in dogs in remission compared to dogs out of remission. Twenty-seven dogs were prospectively enrolled if they had a diagnosis of intermediate to high-grade lymphoma and underwent multidrug chemotherapy. Serial electrocardiogram data were collected under standard conditions and relationships between VVTI, remission status and other clinical variables were evaluated. VVTI from dogs in remission (partial or complete) did not differ from dogs with fulminant lymphoma (naive or at time of relapse). Dogs in partial remission had higher VVTI than dogs in complete remission (p = 0.021). Higher baseline VVTI was associated with higher subsequent scores (p < 0.001). VVTI also correlated with anxiety level (p = 0.03). Based on this pilot study, VVTI did not hold any obvious promise as a useful clinical biomarker of remission status. Further investigation may better elucidate the clinical and prognostic utility of VVTI in dogs with lymphoma.

Steroid/Antiviral for the treatment of Bell's palsy: Double blind randomized clinical trial.

PubMed

Khedr, Eman Mohamed; Badry, Reda; Ali, Anwer Mohamed; Abo El-Fetoh, Noha; El-Hammady, Dina Hatem; Ghandour, Abeer Mohamed; Abdel-Haleem, Ahmed

2016-11-22

A large number of patients with Bell's palsy fail to recover facial function completely after steroid therapy. Only a few small trials have been conducted to test whether outcomes can be improved by the addition of antiviral therapy. To evaluate the efficacy of treatment with steroid alone versus steroid + antiviral in a group of patients with moderately severe to severe acute Bell's palsy. Fifty eligible patients out of a total of 65 with acute onset Bell's palsy were randomized to receive the two treatments. Evaluation was performed before starting treatment, after 2 weeks of treatment and 3 months after onset, using the House and Brackmann facial nerve grading system (HB) and the Sunnybrook grading system.This study was registered with ClinicalTrials.gov, number NCT02328079. Both treatments had comparable demographics and clinical scores at baseline. There was greater improvement in the mean HB and Sunnybrook scores of the steroid + antiviral group in comparison to steroid group at 3 months. At the end of the 3rd month, 17 patients (68%) had good recovery and 8 patients (32%) had poor recovery in the steroid group compared with 23 patients (92%) and 2 (8%) respectively in the steroid and antiviral group (p = 0.034). The combination of steroid and antiviral treatment increases the possibility of recovery in moderately severe to complete acute Bell's palsy.

Organizational culture predicts job satisfaction and perceived clinical effectiveness in pediatric primary care practices.

PubMed

Brazil, Kevin; Wakefield, Dorothy B; Cloutier, Michelle M; Tennen, Howard; Hall, Charles B

2010-01-01

In recent years, there has been a growing understanding that organizational culture is related to an organization's performance. However, few studies have examined organizational culture in medical group practices. The purpose of this study was to examine the relationship of organizational culture on provider job satisfaction and perceived clinical effectiveness in primary care pediatric practices. This cross-sectional study included 36 primary care pediatric practices located in Connecticut. There were 374 participants in this study, which included 127 clinicians and 247 nonclinicians. Office managers completed a questionnaire that recorded staff and practice characteristics; all participants completed the Organizational Culture Scale, a questionnaire that assessed the practice on four cultural domains (i.e., group, developmental, rational, and hierarchical), and the Primary Care Organizational Questionnaire that evaluated perceived effectiveness and job satisfaction. Hierarchical linear models using a restricted maximum likelihood estimation method were used to evaluate whether the practice culture types predicted job satisfaction and perceived effectiveness. Group culture was positively associated with both satisfaction and perceived effectiveness. In contrast, hierarchical and rational culture were negatively associated with both job satisfaction and perceived effectiveness. These relationships were true for clinicians, nonclinicians, and the practice as a whole. Our study demonstrates that practice culture is associated with job satisfaction and perceived clinical effectiveness and that a group culture was associated with high job satisfaction and perceived effectiveness.