Clinical utility of the Wechsler Adult Intelligence Scale-Fourth Edition after traumatic brain injury.

PubMed

Donders, Jacobus; Strong, Carrie-Ann H

2015-02-01

The performance of 100 patients with traumatic brain injury (TBI) on the Wechsler Adult Intelligence Scale-Fourth Edition (WAIS-IV) was compared with that of 100 demographically matched neurologically healthy controls. Processing Speed was the only WAIS-IV factor index that was able to discriminate between persons with moderate-severe TBI on the one hand and persons with either less severe TBI or neurologically healthy controls on the other hand. The Processing Speed index also had acceptable sensitivity and specificity when differentiating between patients with TBI who either did or did not have scores in the clinically significant range on the Trail Making Test. It is concluded that WAIS-IV Processing Speed has acceptable clinical utility in the evaluation of patients with moderate-severe TBI but that it should be supplemented with other measures to assure sufficient accuracy in the diagnostic process. © The Author(s) 2014.

Scanning technology selection impacts acceptability and usefulness of image-rich content*†

PubMed Central

Alpi, Kristine M.; Brown, James C.; Neel, Jennifer A.; Grindem, Carol B.; Linder, Keith E.; Harper, James B.

2016-01-01

Objective Clinical and research usefulness of articles can depend on image quality. This study addressed whether scans of figures in black and white (B&W), grayscale, or color, or portable document format (PDF) to tagged image file format (TIFF) conversions as provided by interlibrary loan or document delivery were viewed as acceptable or useful by radiologists or pathologists. Methods Residency coordinators selected eighteen figures from studies from radiology, clinical pathology, and anatomic pathology journals. With original PDF controls, each figure was prepared in three or four experimental conditions: PDF conversion to TIFF, and scans from print in B&W, grayscale, and color. Twelve independent observers indicated whether they could identify the features and whether the image quality was acceptable. They also ranked all the experimental conditions of each figure in terms of usefulness. Results Of 982 assessments of 87 anatomic pathology, 83 clinical pathology, and 77 radiology images, 471 (48%) were unidentifiable. Unidentifiability of originals (4%) and conversions (10%) was low. For scans, unidentifiability ranged from 53% for color, to 74% for grayscale, to 97% for B&W. Of 987 responses about acceptability (n=405), 41% were said to be unacceptable, 97% of B&W, 66% of grayscale, 41% of color, and 1% of conversions. Hypothesized order (original, conversion, color, grayscale, B&W) matched 67% of rankings (n=215). Conclusions PDF to TIFF conversion provided acceptable content. Color images are rarely useful in grayscale (12%) or B&W (less than 1%). Acceptability of grayscale scans of noncolor originals was 52%. Digital originals are needed for most images. Print images in color or grayscale should be scanned using those modalities. PMID:26807048

Evaluation of XD/A Plus and ST8G films for cephalometric radiography with Grenex G8 and BH-III screens.

PubMed

Wakoh, M; Farman, A G; Scarfe, W C; Shibuya, H; Nishikawa, K; Kuroyanagi, K

1997-02-01

Sensitometric properties, clinical image quality, and patient dose requirements are important considerations when selecting film for cephalometrics. Two recently released films, XD/A Plus and ST 8G green sensitive films, were studied. The films were each combined with Grenex G8 (Fuji Medical) green-fluorescing matched and BH-III (Kasei Optonix) blue-fluorescing mismatched intensifying screens. The density response and resolution for each screen-film combination were evaluated by use of the characteristic curve and modulation transfer function. The kilovoltage settings providing clinically acceptable images were assessed individually by 12 observers. Clinically acceptable images for each combination were also compared, and the skin entrance doses in the temporomandibular joint region were determined. The average contrast at the most effective density range was found to be slightly higher for the BH-III group than for the G8 group. The modulation transfer function for the BH-III group was inferior to that for the G8 screens. There were no significant differences in diagnostically acceptable image quality among the four combinations; nevertheless the BH-III screen group required two to three times more exposure than the G8 screen group. XD/A Plus and ST8G films provide acceptable image detail for cephalometrics. To minimize the patient dose they should be used with green-emitting screens.

Reconciling the professional and student identities of clinical psychology trainees.

PubMed

McKenzie, Karen; Cossar, Jill A; Fawns, Tim; Murray, Aja L

2013-10-01

The study explored the ways in which qualified and trainee clinical psychologists perceived professional behaviour, as illustrated in a series of short vignettes, in student and clinical practice contexts. Comparisons were made to identify the extent to which ideas of professionalism differed across different learning contexts and between qualified and unqualified staff, with the aim of adding to the literature on which factors influence the development of professional identity in health professionals. An online questionnaire depicting a range of potentially unprofessional behaviours was completed by 265 clinical psychology trainees and 106 qualified clinical psychologists. The data were analysed using a general linear model with simultaneous entry in which rater (trainee vs qualified clinical psychologist), setting (student vs placement) and their interaction predicted acceptability ratings. We found that, in general, trainees and qualified staff agreed on those behaviours that were potentially unprofessional, although where significant differences were found, these were due to trainees rating the same behaviours as more professionally acceptable than qualified clinical psychologists. Despite trainees identifying a range of behaviours as professionally unacceptable, some percentage reported having engaged in a similar behaviour in the past. Irrespective of the status of the rater, the same behaviours tended to be viewed as more professionally unacceptable when in a placement (clinical) setting than in a student (university) setting. Generally, no support was found for a rater by setting interaction. The study suggests that trainee clinical psychologists are generally successful at identifying professional norms, although they do not always act in accordance with these. Conflicting student and professional norms may result in trainees viewing some potentially unprofessional behaviour as less severe than qualified staff. Health professional educators should be aware of this fact and take steps to shape trainee norms to be consistent with that of the professional group.

Multicentre knowledge sharing and planning/dose audit on flattening filter free beams for SBRT lung

NASA Astrophysics Data System (ADS)

Hansen, C. R.; Sykes, J. R.; Barber, J.; West, K.; Bromley, R.; Szymura, K.; Fisher, S.; Sim, J.; Bailey, M.; Chrystal, D.; Deshpande, S.; Franji, I.; Nielsen, T. B.; Brink, C.; Thwaites, D. I.

2015-01-01

When implementing new technology into clinical practice, there will always be a need for large knowledge gain. The aim of this study was twofold, (I) audit the treatment planning and dose delivery of Flattening Filter Free (FFF) beam technology for Stereotactic Body Radiation Therapy (SBRT) of lung tumours across a range of treatment planning systems compared to the conventional Flatting Filter (FF) beams, (II) investigate how sharing knowledge between centres of different experience can improve plan quality. All vendor/treatment planning system (TPS) combinations investigated were able to produce acceptable treatment plans and the dose accuracy was clinically acceptable for all plans. By sharing knowledge between the different centres, the minor protocol violations (MPV) could be significantly reduced, from an average of 1.9 MPV per plan to 0.6 after such sharing of treatment planning knowledge. In particular, for the centres with less SBRT and/or volumetric- modulated arc therapy (VMAT) experience the MPV average per plan improved. All vendor/TPS combinations were also able to successfully deliver the FF and FFF SBRT VMAT plans. The plan quality and dose accuracy were found to be clinically acceptable.

What's the Denominator? A Lesson on Risk

ERIC Educational Resources Information Center

Dougherty, Michael J.; McInerney, Joseph D.

2009-01-01

Mathematics is at the heart of all science and is central to the interpretation of research findings in settings ranging from the clinical application of new medications to personal decisions about acceptable levels of risk. Unfortunately, many Americans, including most students, have a poor grasp of mathematics, and rational risk analysis is one…

In Defense of a Social Value Requirement for Clinical Research

PubMed Central

Wendler, David; Rid, Annette

2017-01-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present paper assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. PMID:28060427

In Defense of a Social Value Requirement for Clinical Research.

PubMed

Wendler, David; Rid, Annette

2017-02-01

Many guidelines and commentators endorse the view that clinical research is ethically acceptable only when it has social value, in the sense of collecting data which might be used to improve health. A version of this social value requirement is included in the Declaration of Helsinki and the Nuremberg Code, and is codified in many national research regulations. At the same time, there have been no systematic analyses of why social value is an ethical requirement for clinical research. Recognizing this gap in the literature, recent articles by Alan Wertheimer and David Resnik argue that the extant justifications for the social value requirement are unpersuasive. Both authors conclude, contrary to almost all current guidelines and regulations, that it can be acceptable across a broad range of cases to conduct clinical research which is known prospectively to have no social value. The present article assesses this conclusion by critically evaluating the ethical and policy considerations relevant to the claim that clinical research must have social value. This analysis supports the standard view that social value is an ethical requirement for the vast majority of clinical research studies and should be mandated by applicable guidelines and policies. © 2017 John Wiley & Sons Ltd.

Clinical development of BLZ-100 for real-time optical imaging of tumors during resection

NASA Astrophysics Data System (ADS)

Franklin, Heather L.; Miller, Dennis M.; Hedges, Teresa; Perry, Jeff; Parrish-Novak, Julia

2016-03-01

Complete initial resection can give cancer patients the best opportunity for long-term survival. There is unmet need in surgical oncology for optical imaging that enables simple and precise visualization of tumors and consistent contrast with surrounding normal tissues. Near-infrared (NIR) contrast agents and camera systems that can detect them represent an area of active research and development. The investigational Tumor Paint agent BLZ-100 is a conjugate of a chlorotoxin peptide and the NIR dye indocyanine green (ICG) that has been shown to specifically bind to a broad range of solid tumors. Clinical efficacy studies with BLZ-100 are in progress, a necessary step in bringing the product into clinical practice. To ensure a product that will be useful for and accepted by surgeons, the early clinical development of BLZ- 100 incorporates multiple tumor types and imaging devices so that surgeon feedback covers the range of anticipated clinical uses. Key contrast agent characteristics include safety, specificity, flexibility in timing between dose and surgery, and breadth of tumor types recognized. Imaging devices should use wavelengths that are optimal for the contrast agent, be sensitive enough that contrast agent dosing can be adjusted for optimal contrast, include real-time video display of fluorescence and white light image, and be simple for surgeons to use with minimal disruption of surgical flow. Rapid entry into clinical studies provides the best opportunity for early surgeon feedback, enabling development of agents and devices that will gain broad acceptance and provide information that helps surgeons achieve more complete and precise resections.

Acceptability of Male Circumcision for Prevention of HIV/AIDS in Sub-Saharan Africa: A Review

PubMed Central

Westercamp, N.

2006-01-01

Based on epidemiological, clinical and experimental evidence, male circumcision (MC) could have a significant impact on the HIV epidemic in selected areas. We reviewed studies of the acceptability of MC in sub-Saharan Africa to assess factors that will influence uptake of circumcision in traditionally non-circumcising populations. Thirteen studies from nine countries were identified. Across studies, the median proportion of uncircumcised men willing to become circumcised was 65% (range 29–87%). Sixty nine percent (47–79%) of women favored circumcision for their partners, and 71% (50–90%) of men and 81% (70–90%) of women were willing to circumcise their sons. Because the level of acceptability across the nine countries was quite consistent, additional acceptability studies that pose hypothetical questions to participants are unnecessary. We recommend pilot interventions making safe circumcision services available in conjunction with current HIV prevention strategies and evaluating the safety and acceptability of circumcision. PMID:17053855

Mechanisms of mindfulness training: Monitor and Acceptance Theory (MAT).

PubMed

Lindsay, Emily K; Creswell, J David

2017-02-01

Despite evidence linking trait mindfulness and mindfulness training with a broad range of effects, still little is known about its underlying active mechanisms. Mindfulness is commonly defined as (1) the ongoing monitoring of present-moment experience (2) with an orientation of acceptance. Building on conceptual, clinical, and empirical work, we describe a testable theoretical account to help explain mindfulness effects on cognition, affect, stress, and health outcomes. Specifically, Monitor and Acceptance Theory (MAT) posits that (1), by enhancing awareness of one's experiences, the skill of attention monitoring explains how mindfulness improves cognitive functioning outcomes, yet this same skill can increase affective reactivity. Second (2), by modifying one's relation to monitored experience, acceptance is necessary for reducing affective reactivity, such that attention monitoring and acceptance skills together explain how mindfulness improves negative affectivity, stress, and stress-related health outcomes. We discuss how MAT contributes to mindfulness science, suggest plausible alternatives to the account, and offer specific predictions for future research. Copyright © 2016 Elsevier Ltd. All rights reserved.

Mechanisms of Mindfulness Training: Monitor and Acceptance Theory (MAT)1

PubMed Central

Lindsay, Emily K.; Creswell, J. David

2016-01-01

Despite evidence linking trait mindfulness and mindfulness training with a broad range of effects, still little is known about its underlying active mechanisms. Mindfulness is commonly defined as (1) the ongoing monitoring of present-moment experience (2) with an orientation of acceptance. Building on conceptual, clinical, and empirical work, we describe a testable theoretical account to help explain mindfulness effects on cognition, affect, stress, and health outcomes. Specifically, Monitor and Acceptance Theory (MAT) posits that (1), by enhancing awareness of one’s experiences, the skill of attention monitoring explains how mindfulness improves cognitive functioning outcomes, yet this same skill can increase affective reactivity. Second (2), by modifying one’s relation to monitored experience, acceptance is necessary for reducing affective reactivity, such that attention monitoring and acceptance skills together explain how mindfulness improves negative affectivity, stress, and stress-related health outcomes. We discuss how MAT contributes to mindfulness science, suggest plausible alternatives to the account, and offer specific predictions for future research. PMID:27835764

Determination of reference ranges for elements in human scalp hair.

PubMed

Druyan, M E; Bass, D; Puchyr, R; Urek, K; Quig, D; Harmon, E; Marquardt, W

1998-06-01

Expected values, reference ranges, or reference limits are necessary to enable clinicians to apply analytical chemical data in the delivery of health care. Determination of references ranges is not straightforward in terms of either selecting a reference population or performing statistical analysis. In light of logistical, scientific, and economic obstacles, it is understandable that clinical laboratories often combine approaches in developing health associated reference values. A laboratory may choose to: 1. Validate either reference ranges of other laboratories or published data from clinical research or both, through comparison of patients test data. 2. Base the laboratory's reference values on statistical analysis of results from specimens assayed by the clinical reference laboratory itself. 3. Adopt standards or recommendations of regulatory agencies and governmental bodies. 4. Initiate population studies to validate transferred reference ranges or to determine them anew. Effects of external contamination and anecdotal information from clinicians may be considered. The clinical utility of hair analysis is well accepted for some elements. For others, it remains in the realm of clinical investigation. This article elucidates an approach for establishment of reference ranges for elements in human scalp hair. Observed levels of analytes from hair specimens from both our laboratory's total patient population and from a physician-defined healthy American population have been evaluated. Examination of levels of elements often associated with toxicity serves to exemplify the process of determining reference ranges in hair. In addition the approach serves as a model for setting reference ranges for analytes in a variety of matrices.

Retrospective evaluation of pediatric cranio-spinal axis irradiation plans with the Hi-ART tomotherapy system.

PubMed

Penagaricano, José A; Yan, Yulong; Corry, Peter; Moros, Eduardo; Ratanatharathorn, Vaneerat

2007-08-01

Helical tomotherapy (HT) can be used for the delivery of cranio-spinal axis irradiation (CSAI) without the need for beam matching of conventional linac-based external beam irradiation. The aim of this study is to retrospectively evaluate HT plans used for treatment in nine patients treated with CSAI. Helical tomotherapy cranio-spinal axis irradiation (HT-CSAI) plans were created for each patient. Average length along the cranio-spinal axis of the PTV was 65.6 cm with a range between 53 and 74 cm. Treatment planning optimization and plan evaluation parameters were obtained from the HT planning station for each of the nine patients. PTV coverage by the 95% isodose surface ranged between 98.0 to 100.0% for all nine patients. The clinically acceptable dose variation within the PTV or tolerance range was between 0.7 and 2.5% for all nine patients. Doses to the organs at risk were clinically acceptable. An increasing length along the longitudinal axis of the PTV did not consistently increase the beam-on time indicating that using a larger jaw width had a greater impact on treatment time. With a larger jaw width it is possible to substantially reduce the normalized beam-on treatment time without compromising plan quality and sparing of organs at risk. By using a larger jaw width or lower modulation factor or both, normalized beam-on times were decreased by up to 61% as compared to the other evaluated treatment plans. From the nine cases reported in this study the minimum beam-on time was achieved with a jaw width of 5.0 cm, pitch of 0.287 and a modulation factor of 2.0. Large and long cylindrical volumes can be effectively treated with helical tomotherapy with both clinically acceptable dose distribution and beam-on time.

Acceptability of Pre-Exposure Prophylaxis (PrEP) as an HIV prevention strategy: Barriers and facilitators to PrEP uptake among at-risk Peruvian populations

PubMed Central

Galea, Jerome T.; Kinsler, Janni J.; Salazar, Ximena; Lee, Sung-Jae; Giron, Maziel; Sayles, Jennifer N.; Cáceres, Carlos; Cunningham, William E.

2010-01-01

This study examined Pre-Exposure Prophylaxis (PrEP) acceptability among female sex workers, male-to-female transgendered persons, and men who have sex with men in Lima, Peru. Focus groups explored social issues associated with PrEP acceptability and conjoint analysis assessed preferences among eight hypothetical PrEP scenarios with varying attribute profiles and their relative impact on acceptability. Conjoint analysis revealed that PrEP acceptability ranged from 19.8 to 82.5 out of a possible score of 100 across the eight hypothetical PrEP scenarios. Out-of-pocket cost had the greatest impact on PrEP acceptability (25.2, p <0.001), followed by efficacy (21.4, p <0.001) and potential side effects (14.7, p <0.001). Focus group data supported these findings, and also revealed that potential sexual risk disinhibition, stigma and discrimination associated with PrEP use, and mistrust of health care professionals were also concerns. These issues will require careful attention when planning for PrEP roll-out if proven efficacious in ongoing clinical trials. PMID:21571973

Auditing Access to Outpatient Rehabilitation Services for Children With Traumatic Brain Injury and Public Insurance in Washington State.

PubMed

Fuentes, Molly M; Thompson, Leah; Quistberg, D Alex; Haaland, Wren L; Rhodes, Karin; Kartin, Deborah; Kerfeld, Cheryl; Apkon, Susan; Rowhani-Rahbar, Ali; Rivara, Frederick P

2017-09-01

To identify insurance-based disparities in access to outpatient pediatric neurorehabilitation services. Audit study with paired calls, where callers posed as a mother seeking services for a simulated child with history of severe traumatic brain injury and public or private insurance. Outpatient rehabilitation clinics. Sample of rehabilitation clinics (N=287): 195 physical therapy (PT) clinics, 109 occupational therapy (OT) clinics, 102 speech therapy (ST) clinics, and 11 rehabilitation medicine clinics. Not applicable. Acceptance of public insurance and the number of business days until the next available appointment. Therapy clinics were more likely to accept private insurance than public insurance (relative risk [RR] for PT clinics, 1.33; 95% confidence interval [CI], 1.22-1.44; RR for OT clinics, 1.40; 95% CI, 1.24-1.57; and RR for ST clinics, 1.42; 95% CI, 1.25-1.62), with no significant difference for rehabilitation medicine clinics (RR, 1.10; 95% CI, 0.90-1.34). The difference in median wait time between clinics that accepted public insurance and those accepting only private insurance was 4 business days for PT clinics and 15 days for ST clinics (P≤.001), but the median wait time was not significantly different for OT clinics or rehabilitation medicine clinics. When adjusting for urban and multidisciplinary clinic statuses, the wait time at clinics accepting public insurance was 59% longer for PT (95% CI, 39%-81%), 18% longer for OT (95% CI, 7%-30%), and 107% longer for ST (95% CI, 87%-130%) than that at clinics accepting only private insurance. Distance to clinics varied by discipline and area within the state. Therapy clinics were less likely to accept public insurance than private insurance. Therapy clinics accepting public insurance had longer wait times than did clinics that accepted only private insurance. Rehabilitation professionals should attempt to implement policy and practice changes to promote equitable access to care. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Outcomes Analysis of Chief Cosmetic Clinic Over 13 Years.

PubMed

Walker, Nicholas J; Crantford, John C; Rudolph, Megan A; David, Lisa R

2018-06-01

Adequate resident training in aesthetic surgery has become increasingly important with rising demand. Chief resident aesthetic clinics allow hands on experience with an appropriate amount of autonomy. The purpose of this study was to compare resident cosmetic clinic outcomes to those reported in the literature. Furthermore, we sought to assess how effective these clinics can be in preparing residents in performing common aesthetic surgery procedures. A retrospective chart review of 326 patients and 714 aesthetic procedures in our chief cosmetic clinic over a 13-year period was performed, and complication and revision rates were recorded. In addition, an electronic survey was sent to 26 prior chief residents regarding their experience and impressions of the chief resident aesthetic clinic. A total of 713 procedures were performed on 326 patients. Patient ages ranged from 5 to 75 years old (mean, 40.8 years old) with a mean follow-up of 76.2 days. On average, there were 56 procedures performed per year. Of the 714 total procedures performed, there were 136 minor procedures and 578 major procedures. Of the 136 minor procedures, there were no complications and there was 1 revision of a cosmetic injection. Of the 578 major procedures, the overall complication rate was 6.1% and the revision rate was 12.8%. Complication and revision rates for each individual surgery were further analyzed and compared with the literature. The complication rates for these procedures fell within the reference ranges reported. In regards to the chief resident survey, there was a 77% response rate. All respondents reported that the chief resident clinic positively affected their residency education and future practice. Ninety percent of respondents felt "very comfortable" performing facelifts, body contouring, and aesthetic breast surgery. No respondents completed a subsequent cosmetic fellowship, and 60% stated that their positive experience in chief clinic contributed to their decision not to pursue a cosmetic fellowship. Chief resident clinics can provide results with acceptable complication and revision rates that fall within the acceptable ranges in the literature. In addition, it provides a valuable experience that leaves residents with high comfort levels in performing key procedures in aesthetic surgery.

User acceptance of observation and response charts with a track and trigger system: a multisite staff survey.

PubMed

Elliott, Doug; Allen, Emily; McKinley, Sharon; Perry, Lin; Duffield, Christine; Fry, Margaret; Gallagher, Robyn; Iedema, Rick; Roche, Michael

2016-08-01

To examine user acceptance with a new format of charts for recording observations and as a prompt for responding to episodes of clinical deterioration in adult medical-surgical patients. Improving recognition and response to clinical deterioration remains a challenge for acute healthcare institutions globally. Five chart templates were developed in Australia, combining human factors design principles with a track and trigger system for escalation of care. Two chart templates were previously tested in simulations, but none had been evaluated in clinical practice. Prospective multisite survey of user acceptance of the charts in practice. New observation and response charts were trialled in parallel with existing charts for 24 hours across 36 adult acute medical-surgical wards, covering 108 shifts, in five Australian states. Surveys were completed by 477 staff respondents, with open-ended comments and narrative from short informal feedback groups providing elaboration and context of user experiences. Respondents were broadly supportive of the chart format and content for monitoring patients, and as a prompt for escalating care. Some concerns were noted for chart size and style, use of ranges to graph vital signs and with specific human factors design features. Information and training issues were identified to improve usability and adherence to chart guidelines and to support improved detection and response for patients with clinical deterioration. This initial evaluation demonstrated that the charts were perceived as appropriate for documenting observations and as a prompt to detect clinical deterioration. Further evaluation after some minor modifications to the chart is recommended. Explicit training on the principles and rationale of human factors chart design, use of embedded change management strategies and addressing practical issues will improve authentic engagement, staff acceptance and adoption by all clinical users when implementing a similar observation and response chart into practice. © 2016 John Wiley & Sons Ltd.

Potential Acceptability of a Pediatric Ventilator Management Computer Protocol.

PubMed

Sward, Katherine A; Newth, Christopher J L; Khemani, Robinder G; Page, Kent; Meert, Kathleen L; Carcillo, Joseph A; Shanley, Thomas P; Moler, Frank W; Pollack, Murray M; Dalton, Heidi J; Wessel, David L; Berger, John T; Berg, Robert A; Harrison, Rick E; Doctor, Allan; Dean, J Michael; Holobkov, Richard; Jenkins, Tammara L; Nicholson, Carol E

2017-11-01

To examine issues regarding the granularity (size/scale) and potential acceptability of recommendations in a ventilator management protocol for children with pediatric acute respiratory distress syndrome. Survey/questionnaire. The eight PICUs in the Collaborative Pediatric Critical Care Research Network. One hundred twenty-two physicians (attendings and fellows). None. We used an online questionnaire to examine attitudes and assessed recommendations with 50 clinical scenarios. Overall 80% of scenario recommendations were accepted. Acceptance did not vary by provider characteristics but did vary by ventilator mode (high-frequency oscillatory ventilation 83%, pressure-regulated volume control 82%, pressure control 75%; p = 0.002) and variable adjusted (ranging from 88% for peak inspiratory pressure and 86% for FIO2 changes to 69% for positive end-expiratory pressure changes). Acceptance did not vary based on child size/age. There was a preference for smaller positive end-expiratory pressure changes but no clear granularity preference for other variables. Although overall acceptance rate for scenarios was good, there was little consensus regarding the size/scale of ventilator setting changes for children with pediatric acute respiratory distress syndrome. An acceptable protocol could support robust evaluation of ventilator management strategies. Further studies are needed to determine if adherence to an explicit protocol leads to better outcomes.

Characteristics of lip-mouth region in smiling position from 80 persons with acceptable faces and individual normal occlusions.

PubMed

Zhang, Jiangheng; Chen, Yangxi; Zhou, Xiukun

2002-09-01

The characteristics of lip-mouth region including the soft and hard tissues in smiling position with frontal fixed position photographic computer-aided analysis were studied. The subjects were 80 persons (40 male and 40 females, age range: 17 to approximately 25 years) with acceptable faces and individual normal occlusions. The subjects were asked to take maximum smiling position to accept photographic measurement with computer-aided analysis. The maximum smile line could be divided into 3 categories: low smile line (16.25%), average smile line (68.75%), and high smile line (15%). The method adopting maximum smiling position to study the lip-month region is reproducible and comparable. This study would be helpful to provide a quantitative reference for clinical investigation, diagnosis, treatment and efficacy appraisal.

Feasibility and acceptability of a clinic-based Mediterranean-style diet intervention to reduce cardiovascular risk for Hispanic Americans with type 2 diabetes

PubMed Central

Cubillos, Laura; del Campo, Yanire Estrada; Harbi, Khalil; Keyserling, Thomas; Samuel-Hodge, Carmen; Reuland, Daniel S.

2018-01-01

Purpose The purpose of the study was to modify a previously tested Spanish language version of a Mediterranean (Med)-style dietary intervention so that the dietary recommendations align with the cultural and social needs of Hispanic Americans (HAs) with type 2 diabetes (T2D) and evaluate the modified intervention’s feasibility and acceptability. Methods In phase I (formative), semi-structured interviews and focus groups were used to refine the intervention content and format for delivery to HAs with T2D receiving care at a large primary care practice. In phase II (clinical pilot), the 2-month intervention that promoted a Medstyle dietary pattern was given to all participants via 2 face-to-face counseling sessions and 2 telephone counseling sessions. Major outcomes were engagement with study activities and intervention acceptability; dietary behavior change at 2 months using the PREDIMED Med-diet score (range, 0–14, higher indicating better dietary pattern) is also reported. Results From clinic records, we identified 86 potentially eligible participants and enrolled 21. Baseline characteristics were: mean age = 52 years, 12 (57%) female, 15 (71%) from Mexico, mean years in the US = 19, low acculturation scores for all, and mean BMI = 33.7 kg/m2. Engagement and acceptability were high, with 19 (90%) completing all intervention visits and follow-up measures, all of whom would recommend the program to others. Mean Med-diet score improved from 5.7 to 7.9 (difference = 2.3; 95% CI, 1.0–3.5; P = .001). Conclusions Intervention engagement and acceptability were high, and there was improvement in self-reported dietary behaviors. This type of intervention should be evaluated in randomized trials enrolling HAs with diabetes. PMID:28427311

Feasibility and Acceptability of a Clinic-based Mediterranean-style Diet Intervention to Reduce Cardiovascular Risk for Hispanic Americans With Type 2 Diabetes.

PubMed

Cubillos, Laura; Estrada Del Campo, Yanire; Harbi, Khalil; Keyserling, Thomas; Samuel-Hodge, Carmen; Reuland, Daniel S

2017-06-01

Purpose The purpose of the study was to modify a previously tested Spanish language version of a Mediterranean (Med)-style dietary intervention so that the dietary recommendations align with the cultural and social needs of Hispanic Americans (HAs) with type 2 diabetes (T2D) and evaluate the modified intervention's feasibility and acceptability. Methods In phase I (formative), semi-structured interviews and focus groups were used to refine the intervention content and format for delivery to HAs with T2D receiving care at a large primary care practice. In phase II (clinical pilot), the 2-month intervention that promoted a Med-style dietary pattern was given to all participants via 2 face-to-face counseling sessions and 2 telephone counseling sessions. Major outcomes were engagement with study activities and intervention acceptability; dietary behavior change at 2 months using the PREDIMED Med-diet score (range, 0-14, higher indicating better dietary pattern) is also reported. Results From clinic records, we identified 86 potentially eligible participants and enrolled 21. Baseline characteristics were: mean age = 52 years, 12 (57%) female, 15 (71%) from Mexico, mean years in the US = 19, low acculturation scores for all, and mean BMI = 33.7 kg/m 2 . Engagement and acceptability were high, with 19 (90%) completing all intervention visits and follow-up measures, all of whom would recommend the program to others. Mean Med-diet score improved from 5.7 to 7.9 (difference = 2.3; 95% CI, 1.0-3.5; P = .001). Conclusions Intervention engagement and acceptability were high, and there was improvement in self-reported dietary behaviors. This type of intervention should be evaluated in randomized trials enrolling HAs with diabetes.

Can Temperate-Water Immersion Effectively Reduce Rectal Temperature in Exertional Heat Stroke? A Critically Appraised Topic.

PubMed

Truxton, Tyler T; Miller, Kevin C

2017-09-01

Clinical Scenario: Exertional heat stroke (EHS) is a medical emergency which, if left untreated, can result in death. The standard of care for EHS patients includes confirmation of hyperthermia via rectal temperature (T rec ) and then immediate cold-water immersion (CWI). While CWI is the fastest way to reduce T rec , it may be difficult to lower and maintain water bath temperature in the recommended ranges (1.7°C-15°C [35°F-59°F]) because of limited access to ice and/or the bath being exposed to high ambient temperatures for long periods of time. Determining if T rec cooling rates are acceptable (ie, >0.08°C/min) when significantly hyperthermic humans are immersed in temperate water (ie, ≥20°C [68°F]) has applications for how EHS patients are treated in the field. Are T rec cooling rates acceptable (≥0.08°C/min) when significantly hyperthermic humans are immersed in temperate water? T rec cooling rates of hyperthermic humans immersed in temperate water (≥20°C [68°F]) ranged from 0.06°C/min to 0.19°C/min. The average T rec cooling rate for all examined studies was 0.11±0.06°C/min. Clinical Bottom Line: Temperature water immersion (TWI) provides acceptable (ie, >0.08°C/min) T rec cooling rates for hyperthermic humans post-exercise. However, CWI cooling rates are higher and should be used if feasible (eg, access to ice, shaded treatment areas). Strength of Recommendation: The majority of evidence (eg, Level 2 studies with PEDro scores ≥5) suggests TWI provides acceptable, though not ideal, T rec cooling. If possible, CWI should be used instead of TWI in EHS scenarios.

Emotional control, styles of coping with stress and acceptance of illness among patients suffering from chronic somatic diseases.

PubMed

Janowski, Konrad; Kurpas, Donata; Kusz, Joanna; Mroczek, Bożena; Jedynak, Tomasz

2014-02-01

The purpose of this study was to analyse the associations of emotional control with sociodemographic and clinical variables in a sample of patients with a range of chronic somatic diseases. The relationships between emotional control, coping styles and adjustment to the disease were investigated. The sample consisted of 300 patients with the mean age of 54.60 ± 17.57 years. Courtauld Emotional Control Scale was used to measure the patients' tendency to suppress negative emotions, Coping Inventory for Stressful Situations was used to measure coping styles and Acceptance of Illness Scale was applied to determine adjustment to the disease. Patients with neurological conditions showed significantly lower suppression of anger. Levels of emotional control were found to be related to gender, age and educational level but not to the place of residence. Task-oriented style of coping with stress correlated positively with suppression of depression and anxiety, whereas acceptance of illness correlated negatively with suppression of anger. Levels of emotional control are only weakly related to the type of diagnosis; however, some clinical samples may show lower suppression of anger. Suppression of negative emotions is weakly related to adjustment indicators such as certain coping styles and acceptance of illness. Copyright © 2013 John Wiley & Sons, Ltd.

SU-F-T-538: CyberKnife with MLC for Treatment of Large Volume Tumors: A Feasibility Study

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

Bichay, T; Mayville, A

2016-06-15

Purpose: CyberKnife is a well-documented modality for SRS and SBRT treatments. Typical tumors are small and 1–5 fractions are usually used. We determined the feasibility of using CyberKnife, with an InCise multileaf collimator option, for larger tumors undergoing standard dose and fractionation. The intent was to understand the limitation of using this modality for other external beam radiation treatments. Methods: Five tumors from different anatomical sites with volumes from 127.8 cc to 1,320.5 cc were contoured and planned on a Multiplan V5.1 workstation. The target average diameter ranged from 7 cm to 13 cm. The dose fractionation was 1.8–2.0 Gy/fractionmore » and 25–45 fractions for total doses of 45–81 Gy. The sites planned were: pancreas, head and neck, prostate, anal, and esophagus. The plans were optimized to meet conventional dose constraints based on various RTOG protocols for conventional fractionation. Results: The Multiplan treatment planning system successfully generated clinically acceptable plans for all sites studied. The resulting dose distributions achieved reasonable target coverage, all greater than 95%, and satisfactory normal tissue sparing. Treatment times ranged from 9 minutes to 38 minutes, the longest being a head and neck plan with dual targets receiving different doses and with multiple adjacent critical structures. Conclusion: CyberKnife, with the InCise multileaf collimation option, can achieve acceptable dose distributions in large volume tumors treated with conventional dose and fractionation. Although treatment times are greater than conventional accelerator time; target coverage and dose to critical structures can be kept within a clinically acceptable range. While time limitations exist, when necessary CyberKnife can provide an alternative to traditional treatment modalities for large volume tumors.« less

Various methods for assessing static lower extremity alignment: implications for prospective risk-factor screenings.

PubMed

Nguyen, Anh-Dung; Boling, Michelle C; Slye, Carrie A; Hartley, Emily M; Parisi, Gina L

2013-01-01

Accurate, efficient, and reliable measurement methods are essential to prospectively identify risk factors for knee injuries in large cohorts. To determine tester reliability using digital photographs for the measurement of static lower extremity alignment (LEA) and whether values quantified with an electromagnetic motion-tracking system are in agreement with those quantified with clinical methods and digital photographs. Descriptive laboratory study. Laboratory. Thirty-three individuals participated and included 17 (10 women, 7 men; age = 21.7 ± 2.7 years, height = 163.4 ± 6.4 cm, mass = 59.7 ± 7.8 kg, body mass index = 23.7 ± 2.6 kg/m2) in study 1, in which we examined the reliability between clinical measures and digital photographs in 1 trained and 1 novice investigator, and 16 (11 women, 5 men; age = 22.3 ± 1.6 years, height = 170.3 ± 6.9 cm, mass = 72.9 ± 16.4 kg, body mass index = 25.2 ± 5.4 kg/m2) in study 2, in which we examined the agreement among clinical measures, digital photographs, and an electromagnetic tracking system. We evaluated measures of pelvic angle, quadriceps angle, tibiofemoral angle, genu recurvatum, femur length, and tibia length. Clinical measures were assessed using clinically accepted methods. Frontal- and sagittal-plane digital images were captured and imported into a computer software program. Anatomic landmarks were digitized using an electromagnetic tracking system to calculate static LEA. Intraclass correlation coefficients and standard errors of measurement were calculated to examine tester reliability. We calculated 95% limits of agreement and used Bland-Altman plots to examine agreement among clinical measures, digital photographs, and an electromagnetic tracking system. Using digital photographs, fair to excellent intratester (intraclass correlation coefficient range = 0.70-0.99) and intertester (intraclass correlation coefficient range = 0.75-0.97) reliability were observed for static knee alignment and limb-length measures. An acceptable level of agreement was observed between clinical measures and digital pictures for limb-length measures. When comparing clinical measures and digital photographs with the electromagnetic tracking system, an acceptable level of agreement was observed in measures of static knee angles and limb-length measures. The use of digital photographs and an electromagnetic tracking system appears to be an efficient and reliable method to assess static knee alignment and limb-length measurements.

ORACLE Stroke Study: Opinion Regarding Acceptable Outcome Following Decompressive Hemicraniectomy for Ischemic Stroke.

PubMed

Honeybul, Stephen; Ho, Kwok M; Blacker, David W

2016-08-01

There continues to be considerable interest in the use of decompressive hemicraniectomy in the management of malignant cerebral artery infarction; however, concerns remain about long-term outcome. To assess opinion on consent and acceptable outcome among a wide range of healthcare workers. Seven hundred seventy-three healthcare workers at the 2 major public neurosurgical centers in Western Australia participated. Participants were asked to record their opinion on consent and acceptable outcome based on the modified Rankin Score (mRS). The evidence for clinical efficacy of the procedure was presented, and participants were then asked to reconsider their initial responses. Of the 773 participants included in the study, 407 (52.7%) initially felt that they would provide consent for a decompressive craniectomy as a lifesaving procedure, but only a minority of them considered an mRS score of 4 or 5 an acceptable outcome (for mRS score ≤4, n = 67, 8.7%; for mRS score = 4, n = 57, 7.4%). After the introduction of the concept of the disability paradox and the evidence for the clinical efficacy of decompressive craniectomy, more participants were unwilling to accept decompressive craniectomy (18.1% vs 37.8%), but at the same time, more were willing to accept an mRS score ≤4 as an acceptable outcome (for mRS score ≤4, n = 92, 11.9%; for mRS score = 4, n = 79, 10.2%). Most participants felt survival with dependency to be unacceptable. However, many would be willing to provide consent for surgery in the hopes that they may survive with some degree of independence. DESTINY, Decompressive Surgery for the Treatment of Malignant Infarction of the Middle Cerebral ArterymRS, modified Rankin Scale.

Comparing multiple competing interventions in the absence of randomized trials using clinical risk-benefit analysis

PubMed Central

2012-01-01

Background To demonstrate the use of risk-benefit analysis for comparing multiple competing interventions in the absence of randomized trials, we applied this approach to the evaluation of five anticoagulants to prevent thrombosis in patients undergoing orthopedic surgery. Methods Using a cost-effectiveness approach from a clinical perspective (i.e. risk benefit analysis) we compared thromboprophylaxis with warfarin, low molecular weight heparin, unfractionated heparin, fondaparinux or ximelagatran in patients undergoing major orthopedic surgery, with sub-analyses according to surgery type. Proportions and variances of events defining risk (major bleeding) and benefit (thrombosis averted) were obtained through a meta-analysis and used to define beta distributions. Monte Carlo simulations were conducted and used to calculate incremental risks, benefits, and risk-benefit ratios. Finally, net clinical benefit was calculated for all replications across a range of risk-benefit acceptability thresholds, with a reference range obtained by estimating the case fatality rate - ratio of thrombosis to bleeding. Results The analysis showed that compared to placebo ximelagatran was superior to other options but final results were influenced by type of surgery, since ximelagatran was superior in total knee replacement but not in total hip replacement. Conclusions Using simulation and economic techniques we demonstrate a method that allows comparing multiple competing interventions in the absence of randomized trials with multiple arms by determining the option with the best risk-benefit profile. It can be helpful in clinical decision making since it incorporates risk, benefit, and personal risk acceptance. PMID:22233221

Educational outreach visits to improve venous thromboembolism prevention in hospitalised medical patients: a prospective before-and-after intervention study

PubMed Central

2013-01-01

Background Despite the availability of evidence-based guidelines on venous thromboembolism (VTE) prevention clinical audit and research reveals that hospitalised medical patients frequently receive suboptimal prophylaxis. The aim of this study was to evaluate the acceptability, utility and clinical impact of an educational outreach visit (EOV) on the provision of VTE prophylaxis to hospitalised medical patients in a 270 bed acute care private hospital in metropolitan Australia. Methods The study used an uncontrolled before-and-after design with accompanying process evaluation. The acceptability of the intervention to participants was measured with a post intervention survey; descriptive data on resource use was collected as a measure of utility; and clinical impact (prophylaxis rate) was assessed by pre and post intervention clinical audits. Doctors who admit >40 medical patients each year were targeted to receive the intervention which consisted of a one-to-one educational visit on VTE prevention from a trained peer facilitator. The EOV protocol was designed by a multidisciplinary group of healthcare professionals using social marketing theory. Results Nineteen (73%) of 26 eligible participants received an EOV. The majority (n = 16, 85%) felt the EOV was effective or extremely effective at increasing their knowledge about VTE prophylaxis and 15 (78%) gave a verbal commitment to provide evidence-based prophylaxis. The average length of each visit was 15 minutes (IQ range 15 to 20) and the average time spent arranging and conducting each visit was 92 minutes (IQ range 78 to 129). There was a significant improvement in the proportion of medical patients receiving appropriate pharmacological VTE prophylaxis following the intervention (54% to 70%, 16% improvement, 95% CI 5 to 26, p = 0.004). Conclusions EOV is effective at improving doctors’ provision of pharmacological VTE prophylaxis to hospitalised medical patients. It was also found to be an acceptable implementation strategy by the majority of participants; however, it was resource intensive requiring on average 92 minutes per visit. PMID:24103108

Analysis of lomustine drug content in FDA-approved and compounded lomustine capsules.

PubMed

KuKanich, Butch; Warner, Matt; Hahn, Kevin

2017-02-01

OBJECTIVE To determine the lomustine content (potency) in compounded and FDA-approved lomustine capsules. DESIGN Evaluation study. SAMPLE 2 formulations of lomustine capsules (low dose [7 to 11 mg] and high dose [40 to 48 mg]; 5 capsules/dose/source) from 3 compounders and from 1 manufacturer of FDA-approved capsules. PROCEDURES Lomustine content was measured by use of a validated high-pressure liquid chromatography method. An a priori acceptable range of 90% to 110% of the stated lomustine content was selected on the basis of US Pharmacopeia guidelines. RESULTS The measured amount of lomustine in all compounded capsules was less than the stated content (range, 59% to 95%) and was frequently outside the acceptable range (failure rate, 2/5 to 5/5). Coefficients of variation for lomustine content ranged from 4.1% to 16.7% for compounded low-dose capsules and from 1.1% to 10.8% for compounded high-dose capsules. The measured amount of lomustine in all FDA-approved capsules was slightly above the stated content (range, 104% to 110%) and consistently within the acceptable range. Coefficients of variation for lomustine content were 0.5% for low-dose and 2.3% for high-dose FDA-approved capsules. CONCLUSIONS AND CLINICAL RELEVANCE Compounded lomustine frequently did not contain the stated content of active drug and had a wider range of lomustine content variability than did the FDA-approved product. The sample size was small, and larger studies are needed to confirm these findings; however, we recommend that compounded veterinary formulations of lomustine not be used when appropriate doses can be achieved with FDA-approved capsules or combinations of FDA-approved capsules.

ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging. A report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group.

PubMed

2006-10-01

Under the auspices of the American College of Cardiology Foundation (ACCF) together with key specialty and subspecialty societies, appropriateness reviews were conducted for 2 relatively new clinical cardiac imaging modalities, cardiac computed tomography (CCT) and cardiac magnetic resonance (CMR) imaging. The reviews assessed the risks and benefits of the imaging tests for several indications or clinical scenarios and scored them based on a scale of 1 to 9, where the upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The mid-range (4 to 6) indicates an uncertain clinical scenario. The indications for these reviews were drawn from common applications or anticipated uses, as few clinical practice guidelines currently exist for these techniques. These indications were reviewed by an independent group of clinicians and modified by the Working Group, and then panelists rated the indications based on the ACCF Methodology for Evaluating the Appropriateness of Cardiovascular Imaging, which blends scientific evidence and practice experience. A modified Delphi technique was used to obtain first and second round ratings of clinical indications after the panelists were provided with a set of literature reviews, evidence tables, and seminal references. The final ratings were evenly distributed among the 3 categories of appropriateness for both CCT and CMR. Use of tests for structure and function and for diagnosis in symptomatic, intermediate coronary artery disease (CAD) risk patients was deemed appropriate, while repeat testing and general screening uses were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and future research directions.

Building a Foundation to Reduce Health Inequities: Routine Collection of Sociodemographic Data in Primary Care.

PubMed

Pinto, Andrew D; Glattstein-Young, Gabriela; Mohamed, Anthony; Bloch, Gary; Leung, Fok-Han; Glazier, Richard H

2016-01-01

Detailed data on social determinants of health can facilitate the identification of inequities in access to health care. We report on a sociodemographic data collection tool used in a family medicine clinic. Four major health organizations in Toronto collaborated to identify a set of 14 questions that covered a range of social determinants of health. These were translated into 13 languages. This survey was self-administered using an electronic tablet to a convenience sample of 407 patients in the waiting room of a primary care clinic. Data were uploaded directly to the electronic medical record. The rate of valid responses provided for each question was high, ranging from 84% to 100%. The questions with the highest number of patients selecting "do not know" and "prefer not to answer" pertained to disabilities and income. Patients reported finding the process acceptable. In subsequent implementation across 5 clinics, 10,536 patients have been surveyed; only 724 (6.9%) declined to participate. Collecting data on social determinants of health through a self-administered survey, and linking them to a patient's chart, is feasible and acceptable. A modified survey is now administered to all patients. Such data are already being used to identify health inequities, develop novel interventions, and evaluate their impact on health outcomes. © Copyright 2016 by the American Board of Family Medicine.

Human thermoregulation and measurement of body temperature in exercise and clinical settings.

PubMed

Lim, Chin Leong; Byrne, Chris; Lee, Jason Kw

2008-04-01

This review discusses human thermoregulation during exercise and the measurement of body temperature in clinical and exercise settings. The thermoregulatory mechanisms play important roles in maintaining physiological homeostasis during rest and physical exercise. Physical exertion poses a challenge to thermoregulation by causing a substantial increase in metabolic heat production. However, within a non-thermolytic range, the thermoregulatory mechanisms are capable of adapting to sustain physiological functions under these conditions. The central nervous system may also rely on hyperthermia to protect the body from "overheating." Hyperthermia may serve as a self-limiting signal that triggers central inhibition of exercise performance when a temperature threshold is achieved. Exposure to sub-lethal heat stress may also confer tolerance against higher doses of heat stress by inducing the production of heat shock proteins, which protect cells against the thermolytic effects of heat. Advances in body temperature measurement also contribute to research in thermoregulation. Current evidence supports the use of oral temperature measurement in the clinical setting, although it may not be as convenient as tympanic temperature measurement using the infrared temperature scanner. Rectal and oesophagus temperatures are widely accepted surrogate measurements of core temperature (Tc), but they cause discomfort and are less likely to be accepted by users. Gastrointestinal temperature measurement using the ingestible temperature sensor provides an acceptable level of accuracy as a surrogate measure of Tc without causing discomfort to the user. This form of Tc measurement also allows Tc to be measured continuously in the field and has gained wider acceptance in the last decade.

Assessment of Blood Glucose Control in the Pediatric Intensive Care Unit: Extension of the Glycemic Penalty Index toward Children and Infants

PubMed Central

Van Herpe, Tom; Gielen, Marijke; Vanhonsebrouck, Koen; Wouters, Pieter J; Van den Berghe, Greet; De Moor, Bart; Mesotten, Dieter

2011-01-01

Background: The glycemic penalty index (GPI) is a measure to assess blood glucose (BG) control in critically ill adult patients but needs to be adapted for children and infants. Method: The squared differences between a clinical expertise penalty function and the corresponding polynomial function are minimized for optimization purposes. The average of all penalties (individually assigned to all BG readings) represents the patient-specific GPI. Results: Penalization in the hypoglycemic range is more severe than in the hyperglycemic range as the developing brains of infants and children may be more vulnerable to hypoglycemia. Similarly, hypoglycemia is also more heavily penalized in infants than in children. Conclusions: Extending the adult GPI toward the age-specific GPI is an important methodological step. Long-term clinical studies are needed to determine the clinically acceptable GPI cut-off level. PMID:21527105

Obsessive Compulsive Treatment Efficacy Trial (OCTET) comparing the clinical and cost effectiveness of self-managed therapies: study protocol for a randomised controlled trial.

PubMed

Gellatly, Judith; Bower, Peter; McMillan, Dean; Roberts, Christopher; Byford, Sarah; Bee, Penny; Gilbody, Simon; Arundel, Catherine; Hardy, Gillian; Barkham, Michael; Reynolds, Shirley; Gega, Lina; Mottram, Patricia; Lidbetter, Nicola; Pedley, Rebecca; Peckham, Emily; Connell, Janice; Molle, Jo; O'Leary, Neil; Lovell, Karina

2014-07-10

UK National Institute of Health and Clinical Excellence guidelines for obsessive compulsive disorder (OCD) specify recommendations for the treatment and management of OCD using a stepped care approach. Steps three to six of this model recommend treatment options for people with OCD that range from low-intensity guided self-help (GSH) to more intensive psychological and pharmacological interventions. Cognitive behavioural therapy (CBT), including exposure and response prevention, is the recommended psychological treatment. However, whilst there is some preliminary evidence that self-managed therapy packages for OCD can be effective, a more robust evidence base of their clinical and cost effectiveness and acceptability is required. Our proposed study will test two different self-help treatments for OCD: 1) computerised CBT (cCBT) using OCFighter, an internet-delivered OCD treatment package; and 2) GSH using a book. Both treatments will be accompanied by email or telephone support from a mental health professional. We will evaluate the effectiveness, cost and patient and health professional acceptability of the treatments. This study will provide more robust evidence of efficacy, cost effectiveness and acceptability of self-help treatments for OCD. If cCBT and/or GSH prove effective, it will provide additional, more accessible treatment options for people with OCD. Current Controlled Trials: ISRCTN73535163. Date of registration: 5 April 2011.

Increased 1-year continuation of DMPA among women randomized to self-administration: results from a randomized controlled trial at Planned Parenthood.

PubMed

Kohn, Julia E; Simons, Hannah R; Della Badia, Lisa; Draper, Elissa; Morfesis, Johanna; Talmont, Elizabeth; Beasley, Anitra; McDonald, Melanie; Westhoff, Carolyn L

2018-03-01

Self-administration of subcutaneous depot medroxyprogesterone acetate (DMPA-sc) is feasible, acceptable, and effective. Our objective was to compare one-year continuation of DMPA-sc between women randomized to self-administration versus clinic administration. We randomized 401 females ages 15-44 requesting DMPA at clinics in Texas and New Jersey to self-administration or clinic administration in a 1:1 allocation. Clinic staff taught participants randomized to self-administration to self-inject and observed the first injection; participants received instructions, a sharps container, and three doses for home use. Participants randomized to clinic administration received usual care. All participants received DMPA-sc at no cost and injection reminders via text message or email. We conducted follow-up surveys at six and 12 months. Three hundred thirty-six participants (84%) completed the 12-month survey; 316 completed both follow-up surveys (an 80% response rate excluding eight withdrawals). Participants ranged in age from 16-44. One-year DMPA continuous use was 69% in the self-administration group and 54% in the clinic group (p=.005). There were three self-reported pregnancies during the study period, all occurred in the clinic group; all three women had discontinued DMPA and one reported her pregnancy as intended. Among the self-administration group, 97% reported that self-administration was very or somewhat easy; 87% would recommend self-administration of DMPA-sc to a friend. Among the clinic group, 52% reported interest in self-administration in the future. Satisfaction was similar between groups. No serious adverse events were reported. DMPA self-administration improves contraceptive continuation and is a feasible and acceptable option for women and adolescents. Self-administration of subcutaneous DMPA can improve contraceptive access, autonomy, and continuation, and is a feasible and acceptable option for women and adolescents. It should be made widely available as an option for women and adolescents. Copyright © 2017 Elsevier Inc. All rights reserved.

SU-F-BRD-08: A Novel Technique to Derive a Clinically-Acceptable Beam Model for Proton Pencil-Beam Scanning in a Commercial Treatment Planning System

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

Scholey, J. E.; Lin, L.; Ainsley, C. G.

2015-06-15

Purpose: To evaluate the accuracy and limitations of a commercially-available treatment planning system’s (TPS’s) dose calculation algorithm for proton pencil-beam scanning (PBS) and present a novel technique to efficiently derive a clinically-acceptable beam model. Methods: In-air fluence profiles of PBS spots were modeled in the TPS alternately as single-(SG) and double-Gaussian (DG) functions, based on fits to commissioning data. Uniform-fluence, single-energy-layer square fields of various sizes and energies were calculated with both beam models and delivered to water. Dose was measured at several depths. Motivated by observed discrepancies in measured-versus-calculated dose comparisons, a third model was constructed based on double-Gaussianmore » parameters contrived through a novel technique developed to minimize these differences (DGC). Eleven cuboid-dose-distribution-shaped fields with varying range/modulation and field size were subsequently generated in the TPS, using each of the three beam models described, and delivered to water. Dose was measured at the middle of each spread-out Bragg peak. Results: For energies <160 MeV, the DG model fit square-field measurements to <2% at all depths, while the SG model could disagree by >6%. For energies >160 MeV, both SG and DG models fit square-field measurements to <1% at <4 cm depth, but could exceed 6% deeper. By comparison, disagreement with the DGC model was always <3%. For the cuboid plans, calculation-versus-measured percent dose differences exceeded 7% for the SG model, being larger for smaller fields. The DG model showed <3% disagreement for all field sizes in shorter-range beams, although >5% differences for smaller fields persisted in longer-range beams. In contrast, the DGC model predicted measurements to <2% for all beams. Conclusion: Neither the TPS’s SG nor DG models, employed as intended, are ideally suited for routine clinical use. However, via a novel technique to be presented, its DG model can be tuned judiciously to yield acceptable results.« less

ACCF/ASE/ACEP/AHA/ASNC/SCAI/SCCT/SCMR 2008 appropriateness criteria for stress echocardiography: a report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, American Society of Echocardiography, American College of Emergency Physicians, American Heart Association, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance endorsed by the Heart Rhythm Society and the Society of Critical Care Medicine.

PubMed

Douglas, Pamela S; Khandheria, Bijoy; Stainback, Raymond F; Weissman, Neil J; Peterson, Eric D; Hendel, Robert C; Stainback, Raymond F; Blaivas, Michael; Des Prez, Roger D; Gillam, Linda D; Golash, Terry; Hiratzka, Loren F; Kussmaul, William G; Labovitz, Arthur J; Lindenfeld, JoAnn; Masoudi, Frederick A; Mayo, Paul H; Porembka, David; Spertus, John A; Wann, L Samuel; Wiegers, Susan E; Brindis, Ralph G; Douglas, Pamela S; Hendel, Robert C; Patel, Manesh R; Peterson, Eric D; Wolk, Michael J; Allen, Joseph M

2008-03-18

The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

ACCF/ASE/ACEP/AHA/ASNC/SCAI/SCCT/SCMR 2008 appropriateness criteria for stress echocardiography: a report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, American Society of Echocardiography, American College of Emergency Physicians, American Heart Association, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance: endorsed by the Heart Rhythm Society and the Society of Critical Care Medicine.

PubMed

Douglas, Pamela S; Khandheria, Bijoy; Stainback, Raymond F; Weissman, Neil J; Peterson, Eric D; Hendel, Robert C; Stainback, Raymond F; Blaivas, Michael; Des Prez, Roger D; Gillam, Linda D; Golash, Terry; Hiratzka, Loren F; Kussmaul, William G; Labovitz, Arthur J; Lindenfeld, JoAnn; Masoudi, Frederick A; Mayo, Paul H; Porembka, David; Spertus, John A; Wann, L Samuel; Wiegers, Susan E; Brindis, Ralph G; Douglas, Pamela S; Patel, Manesh R; Wolk, Michael J; Allen, Joseph M

2008-03-18

The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

ACCF/ASE/ACEP/AHA/ASNC/SCAI/SCCT/SCMR 2008 Appropriateness Criteria for Stress Echocardiography. A report of the American College of Cardiology Foundation Appropriateness Criteria Task Force, American Society of Echocardiography, American College of Emergency Physicians, American Heart Association, American Society of Nuclear Cardiology, Society for Cardiovascular Angiography and Interventions, Society of Cardiovascular Computed Tomography, and Society for Cardiovascular Magnetic Resonance endorsed by the Heart Rhythm Society and the Society of Critical Care Medicine.

PubMed

Douglas, Pamela S; Khandheria, Bijoy; Stainback, Raymond F; Weissman, Neil J; Peterson, Eric D; Hendel, Robert C; Stainback, Raymond F; Blaivas, Michael; Des Prez, Roger D; Gillam, Linda D; Golash, Terry; Hiratzka, Loren F; Kussmaul, William G; Labovitz, Arthur J; Lindenfeld, Joann; Masoudi, Frederick A; Mayo, Paul H; Porembka, David; Spertus, John A; Wann, L Samuel; Wiegers, Susan E; Brindis, Ralph G; Douglas, Pamela S; Hendel, Robert C; Patel, Manesh R; Peterson, Eric D; Wolk, Michael J; Allen, Joseph M

2008-04-01

The American College of Cardiology Foundation (ACCF) and the American Society of Echocardiography (ASE) together with key specialty and subspecialty societies, conducted an appropriateness review for stress echocardiography. The review assessed the risks and benefits of stress echocardiography for several indications or clinical scenarios and scored them on a scale of 1 to 9 (based upon methodology developed by the ACCF to assess imaging appropriateness). The upper range (7 to 9) implies that the test is generally acceptable and is a reasonable approach, and the lower range (1 to 3) implies that the test is generally not acceptable and is not a reasonable approach. The midrange (4 to 6) indicates a clinical scenario for which the indication for a stress echocardiogram is uncertain. The indications for this review were drawn from common applications or anticipated uses, as well as from current clinical practice guidelines. Use of stress echocardiography for risk assessment in patients with coronary artery disease (CAD) was viewed favorably, while routine repeat testing and general screening in certain clinical scenarios were viewed less favorably. It is anticipated that these results will have a significant impact on physician decision making and performance, reimbursement policy, and will help guide future research.

Translucency thresholds for dental materials.

PubMed

Salas, Marianne; Lucena, Cristina; Herrera, Luis Javier; Yebra, Ana; Della Bona, Alvaro; Pérez, María M

2018-05-12

To determine the translucency acceptability and perceptibility thresholds for dental resin composites using CIEDE2000 and CIELAB color difference formulas. A 30-observer panel performed perceptibility and acceptability judgments on 50 pairs of resin composites discs (diameter: 10mm; thickness: 1mm). Disc pair differences for the Translucency Parameter (ΔTP) were calculated using both color difference formulas (ΔTP 00 ranged from 0.11 to 7.98, and ΔTP ab ranged from 0.01 to 12.79). A Takagi-Sugeno-Kang (TSK) Fuzzy Approximation was used as fitting procedure. From the resultant fitting curves, the 95% confidence intervals were estimated and the 50:50% translucency perceptibility and acceptability thresholds (TPT and TAT) were calculated. Differences between thresholds were statistically analyzed using Student t tests (α=0.05). CIEDE2000 50:50% TPT was 0.62 and TAT was 2.62. Corresponding CIELAB values were 1.33 and 4.43, respectively. Translucency perceptibility and acceptability thresholds were significantly different using both color difference formulas (p=0.01 for TPT and p=0.005 for TAT). CIEDE2000 color difference formula provided a better data fit than CIELAB formula. The visual translucency difference thresholds determined with CIEDE2000 color difference formula can serve as reference values in the selection of resin composites and evaluation of its clinical performance. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Residual hormone levels in used contraceptive rings as a measurement of adherence to vaginal ring use.

PubMed

Haaland, Richard E; Holder, Angela; Evans-Strickfaden, Tammy; Nyagol, Beatrice; Makanga, Mumbi; Oyaro, Boaz; Humwa, Felix; Williams, Tiffany; McLellan-Lemal, Eleanor; Desai, Mitesh; Huey, Michael J

2017-06-01

This study sought to measure residual contraceptive hormone levels in vaginal rings as an adherence marker for monitoring product use in clinical trials. Residual etonogestrel and ethinyl estradiol levels from used NuvaRings® of 26 self-reported adherent women enrolled in a clinical trial of vaginal ring acceptability were compared to those from 16 women who used NuvaRing® as their contraceptive choice. Twenty-one (81%) clinical trial rings had contraceptive hormone levels within the range of those used as a contraceptive choice. Five returned rings had unused or discordant levels of residual contraceptive hormones. Residual vaginal ring drug levels could help assess adherence in clinical trials. Published by Elsevier Inc.

If Euhydric and Isotonic Do Not Work, What Are Acceptable pH and Osmolality for Parenteral Drug Dosage Forms?

PubMed

Roethlisberger, Dieter; Mahler, Hanns-Christian; Altenburger, Ulrike; Pappenberger, Astrid

2017-02-01

Parenteral products should aim toward being isotonic and euhydric (physiological pH). Yet, due to other considerations, this goal is often not reasonable or doable. There are no clear allowable ranges related to pH and osmolality, and thus, the objective of this review was to provide a better understanding of acceptable formulation pH, buffer strength, and osmolality taking into account the administration route (i.e., intramuscular, intravenous, subcutaneous) and administration technique (i.e., bolus, push, infusion). This evaluation was based on 3 different approaches: conventional, experimental, and parametric. The conventional way of defining formulation limits was based on standard pH and osmolality ranges. Experimental determination of titratable acidity or in vitro hemolysis testing provided additional drug product information. Finally, the parametric approach was based on the calculation of theoretical values such as (1) the maximal volume of injection which cannot shift the blood's pH or its molarity out of the physiological range and (b) a dilution ratio at the injection site and by verifying that threshold values are not exceeded. The combination of all 3 approaches can support the definition of acceptable pH, buffer strength, and osmolality of formulations and thus may reduce the risk of failure during preclinical and clinical development. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Researchers' views of the acceptability of restrictive provisions in clinical trial agreements with industry sponsors.

PubMed

Mello, Michelle M; Clarridge, Brian R; Studdert, David M

2005-01-01

We conducted a mail survey of 884 U.S. medical school faculty active in clinical research to elicit their views about the acceptability of provisions in contracts for industry-sponsored clinical trials that would restrict investigators' academic freedom and control over trials. We compared their responses to results from a similar survey of research administrators at 107 medical schools. There was substantial variation among clinical researchers in their acceptability judgments, with a relatively large proportion of clinical trial investigators willing to accept provisions that give industry sponsors considerable control over the dissemination of research results. There were significant differences in the perceptions of clinical trial investigators versus other recently published clinical researchers; investigators with a high versus low percentage of research support from industry; junior versus senior faculty; and investigators at institutions with high versus low National Institute of Health (NIH) funding ranks. There was also a significant divergence of views in a number of areas between clinical trialists and research administrators who negotiate clinical trial contracts on their behalf. Medical school faculty could benefit from additional guidance about what their institution views as acceptable parameters for industry-sponsored clinical trial agreements.

Feasibility of the Nintendo WiiFit™ for improving walking in individuals with a lower limb amputation

PubMed Central

Imam, Bita; McLaren, Linda; Chapman, Paul; Finlayson, Heather

2013-01-01

Objectives: To evaluate the feasibility of the Nintendo WiiFit™ as an adjunct to usual therapy in individuals with a lower limb amputation. Methods: The study was a Multiple Baseline (AB) Single Subject Research Design. Subjects were ≥19 years old, had their first unilateral transtibial or transfemoral amputation  ≤12 months ago, and were participating in prosthetic training. WiiFit training was provided for 30 min, 5 times a week, for a minimum of 2 and a maximum of 6 weeks in addition to usual therapy. Feasibility indicators were safety, post-intervention fatigue and pain levels, adherence, and subject’s acceptability of the program as measured by the Short Feedback Questionnaire–modified (SFQ-M). The primary clinical outcome was walking capacity assessed by the 2 Minute Walk Test (2MWT). The secondary clinical outcomes were the Short Physical Performance Battery, L-test, and Activities-Specific Balance Confidence. Results: Subjects (4 transtibial; 2 transfemoral) had a median age of 48.5 years (range = 45–59 years). No adverse events associated with the intervention occurred. Median pain and fatigue levels were 1.3 (range = 0.5–3.5) and 3.1 (range = 1.4–4.1), respectively. Median adherence was 80%. Subjects found the WiiFit enjoyable and acceptable (median SFQ-M = 35). Five subjects showed statistical improvement on the 2MWT and four on the secondary outcomes (p < 0.05). Conclusion: The WiiFit intervention was found to be feasible in individuals with unilateral lower limb amputation. This research provides the foundation for future clinical research investigating the use of the WiiFit as a viable adjunctive therapy to improve outcomes in individuals with unilateral lower limb amputation who are participating in prosthetic training. PMID:26770676

Feasibility of the Nintendo WiiFit™ for improving walking in individuals with a lower limb amputation.

PubMed

Imam, Bita; Miller, William C; McLaren, Linda; Chapman, Paul; Finlayson, Heather

2013-01-01

To evaluate the feasibility of the Nintendo WiiFit™ as an adjunct to usual therapy in individuals with a lower limb amputation. The study was a Multiple Baseline (AB) Single Subject Research Design. Subjects were ≥19 years old, had their first unilateral transtibial or transfemoral amputation  ≤12 months ago, and were participating in prosthetic training. WiiFit training was provided for 30 min, 5 times a week, for a minimum of 2 and a maximum of 6 weeks in addition to usual therapy. Feasibility indicators were safety, post-intervention fatigue and pain levels, adherence, and subject's acceptability of the program as measured by the Short Feedback Questionnaire-modified (SFQ-M). The primary clinical outcome was walking capacity assessed by the 2 Minute Walk Test (2MWT). The secondary clinical outcomes were the Short Physical Performance Battery, L-test, and Activities-Specific Balance Confidence. Subjects (4 transtibial; 2 transfemoral) had a median age of 48.5 years (range = 45-59 years). No adverse events associated with the intervention occurred. Median pain and fatigue levels were 1.3 (range = 0.5-3.5) and 3.1 (range = 1.4-4.1), respectively. Median adherence was 80%. Subjects found the WiiFit enjoyable and acceptable (median SFQ-M = 35). Five subjects showed statistical improvement on the 2MWT and four on the secondary outcomes (p < 0.05). The WiiFit intervention was found to be feasible in individuals with unilateral lower limb amputation. This research provides the foundation for future clinical research investigating the use of the WiiFit as a viable adjunctive therapy to improve outcomes in individuals with unilateral lower limb amputation who are participating in prosthetic training.

Ultrasound transducer function: annual testing is not sufficient.

PubMed

Mårtensson, Mattias; Olsson, Mats; Brodin, Lars-Åke

2010-10-01

The objective was to follow-up the study 'High incidence of defective ultrasound transducers in use in routine clinical practice' and evaluate if annual testing is good enough to reduce the incidence of defective ultrasound transducers in routine clinical practice to an acceptable level. A total of 299 transducers were tested in 13 clinics at five hospitals in the Stockholm area. Approximately 7000-15,000 ultrasound examinations are carried out at these clinics every year. The transducers tested in the study had been tested and classified as fully operational 1 year before and since then been in normal use in the routine clinical practice. The transducers were tested with the Sonora FirstCall Test System. There were 81 (27.1%) defective transducers found; giving a 95% confidence interval ranging from 22.1 to 32.1%. The most common transducer errors were 'delamination' of the ultrasound lens and 'break in the cable' which together constituted 82.7% of all transducer errors found. The highest error rate was found at the radiological clinics with a mean error rate of 36.0%. There was a significant difference in error rate between two observed ways the clinics handled the transducers. There was no significant difference in the error rates of the transducer brands or the transducers models. Annual testing is not sufficient to reduce the incidence of defective ultrasound transducers in routine clinical practice to an acceptable level and it is strongly advisable to create a user routine that minimizes the handling of the transducers.

Usability and Acceptability of ASSESS MS: Assessment of Motor Dysfunction in Multiple Sclerosis Using Depth-Sensing Computer Vision.

PubMed

Morrison, Cecily; D'Souza, Marcus; Huckvale, Kit; Dorn, Jonas F; Burggraaff, Jessica; Kamm, Christian Philipp; Steinheimer, Saskia Marie; Kontschieder, Peter; Criminisi, Antonio; Uitdehaag, Bernard; Dahlke, Frank; Kappos, Ludwig; Sellen, Abigail

2015-06-24

Sensor-based recordings of human movements are becoming increasingly important for the assessment of motor symptoms in neurological disorders beyond rehabilitative purposes. ASSESS MS is a movement recording and analysis system being developed to automate the classification of motor dysfunction in patients with multiple sclerosis (MS) using depth-sensing computer vision. It aims to provide a more consistent and finer-grained measurement of motor dysfunction than currently possible. To test the usability and acceptability of ASSESS MS with health professionals and patients with MS. A prospective, mixed-methods study was carried out at 3 centers. After a 1-hour training session, a convenience sample of 12 health professionals (6 neurologists and 6 nurses) used ASSESS MS to capture recordings of standardized movements performed by 51 volunteer patients. Metrics for effectiveness, efficiency, and acceptability were defined and used to analyze data captured by ASSESS MS, video recordings of each examination, feedback questionnaires, and follow-up interviews. All health professionals were able to complete recordings using ASSESS MS, achieving high levels of standardization on 3 of 4 metrics (movement performance, lateral positioning, and clear camera view but not distance positioning). Results were unaffected by patients' level of physical or cognitive disability. ASSESS MS was perceived as easy to use by both patients and health professionals with high scores on the Likert-scale questions and positive interview commentary. ASSESS MS was highly acceptable to patients on all dimensions considered, including attitudes to future use, interaction (with health professionals), and overall perceptions of ASSESS MS. Health professionals also accepted ASSESS MS, but with greater ambivalence arising from the need to alter patient interaction styles. There was little variation in results across participating centers, and no differences between neurologists and nurses. In typical clinical settings, ASSESS MS is usable and acceptable to both patients and health professionals, generating data of a quality suitable for clinical analysis. An iterative design process appears to have been successful in accounting for factors that permit ASSESS MS to be used by a range of health professionals in new settings with minimal training. The study shows the potential of shifting ubiquitous sensing technologies from research into the clinic through a design approach that gives appropriate attention to the clinic environment.

Usability and Acceptability of ASSESS MS: Assessment of Motor Dysfunction in Multiple Sclerosis Using Depth-Sensing Computer Vision

PubMed Central

Dorn, Jonas F; Burggraaff, Jessica; Kamm, Christian Philipp; Steinheimer, Saskia Marie; Kontschieder, Peter; Criminisi, Antonio; Uitdehaag, Bernard; Dahlke, Frank; Kappos, Ludwig; Sellen, Abigail

2015-01-01

Background Sensor-based recordings of human movements are becoming increasingly important for the assessment of motor symptoms in neurological disorders beyond rehabilitative purposes. ASSESS MS is a movement recording and analysis system being developed to automate the classification of motor dysfunction in patients with multiple sclerosis (MS) using depth-sensing computer vision. It aims to provide a more consistent and finer-grained measurement of motor dysfunction than currently possible. Objective To test the usability and acceptability of ASSESS MS with health professionals and patients with MS. Methods A prospective, mixed-methods study was carried out at 3 centers. After a 1-hour training session, a convenience sample of 12 health professionals (6 neurologists and 6 nurses) used ASSESS MS to capture recordings of standardized movements performed by 51 volunteer patients. Metrics for effectiveness, efficiency, and acceptability were defined and used to analyze data captured by ASSESS MS, video recordings of each examination, feedback questionnaires, and follow-up interviews. Results All health professionals were able to complete recordings using ASSESS MS, achieving high levels of standardization on 3 of 4 metrics (movement performance, lateral positioning, and clear camera view but not distance positioning). Results were unaffected by patients’ level of physical or cognitive disability. ASSESS MS was perceived as easy to use by both patients and health professionals with high scores on the Likert-scale questions and positive interview commentary. ASSESS MS was highly acceptable to patients on all dimensions considered, including attitudes to future use, interaction (with health professionals), and overall perceptions of ASSESS MS. Health professionals also accepted ASSESS MS, but with greater ambivalence arising from the need to alter patient interaction styles. There was little variation in results across participating centers, and no differences between neurologists and nurses. Conclusions In typical clinical settings, ASSESS MS is usable and acceptable to both patients and health professionals, generating data of a quality suitable for clinical analysis. An iterative design process appears to have been successful in accounting for factors that permit ASSESS MS to be used by a range of health professionals in new settings with minimal training. The study shows the potential of shifting ubiquitous sensing technologies from research into the clinic through a design approach that gives appropriate attention to the clinic environment. PMID:27025782

Results from a clinical yoga program for veterans: yoga via telehealth provides comparable satisfaction and health improvements to in-person yoga.

PubMed

Schulz-Heik, R Jay; Meyer, Hilary; Mahoney, Louise; Stanton, Michael V; Cho, Rachael H; Moore-Downing, Danae P; Avery, Timothy J; Lazzeroni, Laura C; Varni, Joanne M; Collery, Linda Martin; Bayley, Peter J

2017-04-04

Yoga is increasingly popular, though little data regarding its implementation in healthcare settings is available. Similarly, telehealth is being utilized more frequently to increase access to healthcare; however we know of no research on the acceptability or effectiveness of yoga delivered through telehealth. Therefore, we evaluated the feasibility, acceptability, and patient-reported effectiveness of a clinical yoga program at a Veterans Affairs Medical Center and assessed whether these outcomes differed between those participating in-person and those participating via telehealth. Veterans who attended a yoga class at the VA Palo Alto Health Care System were invited to complete an anonymous program evaluation survey. 64 Veterans completed the survey. Participants reported high satisfaction with the classes and the instructors. More than 80% of participants who endorsed a problem with pain, energy level, depression, or anxiety reported improvement in these symptoms. Those who participated via telehealth did not differ from those who participated in-person in any measure of satisfaction, overall improvement (p = .40), or improvement in any of 16 specific health problems. Delivering yoga to a wide range of patients within a healthcare setting appears to be feasible and acceptable, both when delivered in-person and via telehealth. Patients in this clinical yoga program reported high levels of satisfaction and improvement in multiple problem areas. This preliminary evidence for the effectiveness of a clinical yoga program complements prior evidence for the efficacy of yoga and supports the use of yoga in healthcare settings.

Factors influencing alert acceptance: a novel approach for predicting the success of clinical decision support

PubMed Central

Seidling, Hanna M; Phansalkar, Shobha; Seger, Diane L; Paterno, Marilyn D; Shaykevich, Shimon; Haefeli, Walter E

2011-01-01

Background Clinical decision support systems can prevent knowledge-based prescription errors and improve patient outcomes. The clinical effectiveness of these systems, however, is substantially limited by poor user acceptance of presented warnings. To enhance alert acceptance it may be useful to quantify the impact of potential modulators of acceptance. Methods We built a logistic regression model to predict alert acceptance of drug–drug interaction (DDI) alerts in three different settings. Ten variables from the clinical and human factors literature were evaluated as potential modulators of provider alert acceptance. ORs were calculated for the impact of knowledge quality, alert display, textual information, prioritization, setting, patient age, dose-dependent toxicity, alert frequency, alert level, and required acknowledgment on acceptance of the DDI alert. Results 50 788 DDI alerts were analyzed. Providers accepted only 1.4% of non-interruptive alerts. For interruptive alerts, user acceptance positively correlated with frequency of the alert (OR 1.30, 95% CI 1.23 to 1.38), quality of display (4.75, 3.87 to 5.84), and alert level (1.74, 1.63 to 1.86). Alert acceptance was higher in inpatients (2.63, 2.32 to 2.97) and for drugs with dose-dependent toxicity (1.13, 1.07 to 1.21). The textual information influenced the mode of reaction and providers were more likely to modify the prescription if the message contained detailed advice on how to manage the DDI. Conclusion We evaluated potential modulators of alert acceptance by assessing content and human factors issues, and quantified the impact of a number of specific factors which influence alert acceptance. This information may help improve clinical decision support systems design. PMID:21571746

Neurocognition, presence and acceptance of a VR programme for psychotic patients: a correlational study.

PubMed

Rus-Calafell, Mar; Gutiérrez-Maldonado, José; Ribas-Sabaté, Joan

2013-01-01

Patients with psychosis exhibit a wide range of cognitive deficits which are associated with poor functioning and poor outcomes in psychosocial interventions. Recently, virtual reality (VR) has been demonstrated to be a useful tool for treatment and rehabilitation of these patients. We have developed and applied an integrated VR programme to improve social skills in people with schizophrenia: the Soskitrain. The aim of the present study is to evaluate the relationship between patients' cognitive deficits, their sense of presence and their ratings of the programme's acceptability. Twelve clinically stabilized outpatients with a well-established diagnosis of schizophrenia or schizoaffective disorder underwent neuropsychological assessment prior to treatment, while after the intervention they completed a questionnaire about their sense of presence and the acceptability of the VR programme. Post-treatment results revealed a high sense of presence among patients, as well as good verisimilitude and high acceptance of the virtual environments. In addition, there were significant negative correlations between sense of presence and deficits in both delayed verbal learning and processing speed. The paper discusses the implications of cognitive impairment for the experience and acceptance of VR when treating psychotic patients.

Impact of an Acceptance Facilitating Intervention on Patients' Acceptance of Internet-based Pain Interventions: A Randomized Controlled Trial.

PubMed

Baumeister, Harald; Seifferth, Holger; Lin, Jiaxi; Nowoczin, Lisa; Lüking, Marianne; Ebert, David

2015-06-01

Results from clinical trials indicate that Internet-based psychological pain interventions are effective in treating chronic pain. However, little is known about patients' acceptance of these programs and how to positively influence patients' intention to engage in them. Therefore, the present study aimed (1) to assess patients' acceptance of Internet-based interventions, and (2) to examine whether patients' acceptance can be increased by an acceptance facilitating intervention. A total of 104 patients with chronic pain from 2 pain units were randomly allocated to an intervention group (IG) and a no-intervention control group (CG). The IG was shown a short informational video about Internet-based psychological pain interventions before receiving a questionnaire on patients' acceptance of Internet-based psychological pain interventions and predictors of acceptance (performance expectancy, effort expectancy, social influence, facilitating conditions, Internet usage, and Internet anxiety). The CG filled out the questionnaire immediately. Patients' acceptance was measured with a 4-item scale (sum score ranging from 4 to 20). Baseline acceptance of Internet-based interventions was reported as low (sum-score:4-9) by 53.8%, moderate (10 to 15) by 42.3%, and high (16 to 20) by 3.9% of the patients with chronic pain in the CG. The IG showed a significantly higher acceptance (M = 12.17, SD = 4.22) than the CG (M = 8.94, SD = 3.71) with a standardized mean difference of d = 0.81 (95% CI, 0.41, 1.21). All predictor variables were significantly improved in the IG compared with the CG, except for Internet usage. Patients with chronic pain display a relatively low acceptance of Internet-based psychological pain interventions, which can be substantially increased by a short informational video.

Impact of an acceptance facilitating intervention on diabetes patients' acceptance of Internet-based interventions for depression: a randomized controlled trial.

PubMed

Baumeister, H; Nowoczin, L; Lin, J; Seifferth, H; Seufert, J; Laubner, K; Ebert, D D

2014-07-01

To (1) determine diabetes patients' acceptance of Internet-based interventions (IBIs) for depression, to (2) examine the effectiveness of an acceptance facilitating intervention (AFI) and to (3) explore subgroup specific effects. 141 diabetes patients from two inpatient rehabilitation units and one outpatient clinic in Germany were randomly allocated to an intervention (IG) and a no-intervention control group (CG). The IG received an AFI consisting of a personal information session before filling-out a questionnaire on patients' acceptance of IBIs, predictors of acceptance (performance expectancy, effort expectancy, social influence, facilitating conditions, and Internet anxiety) as well as sociodemographic, depression-related and diabetes-related variables. The CG filled out the questionnaire immediately. Patients' acceptance of IBIs was measured with a four-item scale (sum-score ranging from 4 to 20). The CG showed a low (50.7%) to medium (40.8%) acceptance with only 8.5% of all diabetes patients reporting a high acceptance of IBIs for depression. The AFI had no significant effect on acceptance (IG: M=10.55, SD=4.69, n=70; KG: M=9.65, SD=4.27, n=71; d=0.20 [95%-CI: -0.13;0.53]) and the predictors of acceptance. Yet, subgroup analyses yielded a trend for depressed, diabetes-related distressed, female and younger (<59) participants and for those who do not frequently use the Internet to profit from the AFI. Diabetes patients show a rather low acceptance toward IBIs for depression. Findings indicate that the AFI is likely to be effective in the subgroup of depressed, diabetes-related distressed, female or younger diabetes patients, but not in the whole target population. Hence, AFIs might need to be tailored to the specific needs of subpopulations. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Point-of-care Cognitive Support Technology in Emergency Departments: A Scoping Review of Technology Acceptance by Clinicians.

PubMed

Jun, Shelly; Plint, Amy C; Campbell, Sandy M; Curtis, Sarah; Sabir, Kyrellos; Newton, Amanda S

2018-05-01

Cognitive support technologies that support clinical decisions and practices in the emergency department (ED) have the potential to optimize patient care. However, limited uptake by clinicians can prevent successful implementation. A better understanding of acceptance of these technologies from the clinician perspective is needed. We conducted a scoping review to synthesize diverse, emerging evidence on clinicians' acceptance of point-of-care (POC) cognitive support technology in the ED. We systematically searched 10 electronic databases and gray literature published from January 2006 to December 2016. Studies of any design assessing an ED-based POC cognitive support technology were considered eligible for inclusion. Studies were required to report outcome data for technology acceptance. Two reviewers independently screened studies for relevance and quality. Study quality was assessed using the Mixed-Methods Appraisal Tool. A descriptive analysis of the features of POC cognitive support technology for each study is presented, illustrating trends in technology development and evaluation. A thematic analysis of clinician, technical, patient, and organizational factors associated with technology acceptance is also presented. Of the 1,563 references screened for eligibility, 24 met the inclusion criteria and were included in the review. Most studies were published from 2011 onward (88%), scored high for methodologic quality (79%), and examined POC technologies that were novel and newly introduced into the study setting (63%). Physician use of POC technology was the most commonly studied (67%). Technology acceptance was frequently conceptualized and measured by factors related to clinician attitudes and beliefs. Experience with the technology, intention to use, and actual use were also more common outcome measures of technology acceptance. Across studies, perceived usefulness was the most noteworthy factor impacting technology acceptance, and clinicians generally had positive perceptions of the use of POC cognitive support technology in the ED. However, the actual use of POC cognitive support technology reported by clinicians was low-use, by proportion of patient cases, ranged from 30% to 59%. Of the 24 studies, only two studies investigated acceptance of POC cognitive support technology currently implemented in the ED, offering "real-world" clinical practice data. All other studies focused on acceptance of novel technologies. Technical aspects such as an unfriendly user interface, presentation of redundant or ambiguous information, and required user effort had a negative impact on acceptance. Patient expectations were also found to have a negative impact, while patient safety implications had a positive impact. Institutional support was also reported to impact technology acceptance. Findings from this scoping review suggest that while ED clinicians acknowledge the utility and value of using POC cognitive support technology, actual use of such technology can be low. Further, few studies have evaluated the acceptance and use of POC technologies in routine care. Prospective studies that evaluate how ED clinicians appraise and consider POC technology use in clinical practice are now needed with diverse clinician samples. While this review identified multiple factors contributing to technology acceptance, determining how clinician, technical, patient, and organizational factors mediate or moderate acceptance should also be a priority. © 2017 by the Society for Academic Emergency Medicine.

Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States

PubMed Central

van der Straten, Ariane; Panther, Lori; Laborde, Nicole; Hoesley, Craig; Cheng, Helen; Husnik, Marla; Horn, Stephanie; Nel, Annalene; Soto-Torres, Lydia; Chen, Beatrice A.

2016-01-01

We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18 to 40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98% (47/48); 94% (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44% preferred continuous use, whereas 51% had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery. PMID:26837628

Adherence and Acceptability of a Multidrug Vaginal Ring for HIV Prevention in a Phase I Study in the United States.

PubMed

van der Straten, Ariane; Panther, Lori; Laborde, Nicole; Hoesley, Craig J; Cheng, Helen; Husnik, Marla J; Horn, Stephanie; Nel, Annalene; Soto-Torres, Lydia; Chen, Beatrice A

2016-11-01

We evaluated the adherence and acceptability of a vaginal ring containing dapivirine, maraviroc, or both drugs for 28 days during a Phase I placebo-controlled trial in 48 HIV-negative sexually abstinent U.S. women aged 18-40. Adherence was assessed weekly by clinical interview and computer-assisted self-interviewing; acceptability assessment occurred at the last product-use visit. Study retention was 98 % (47/48); 94 % (45/48) reported being fully adherent with ring use during the 28-day period. Two participants experienced the ring partially coming out. Analysis was blinded and behavioral data were combined across study groups. Most women reported being very comfortable having the ring in their vagina; 44 % preferred continuous use, whereas 51 % had no preference compared to episodic use. Although a range of minor ring concerns were expressed, few were actually experienced. High adherence to and acceptability of this vaginal ring in this Phase I trial contributes to its promise as a sustained mechanism for multidrug vaginal microbicide delivery.

A roadmap to defining the clinical reportable ranges of chemistry analytes: Increasing automation efficiency and decreasing manual dilutions.

PubMed

Lo, Sheng-Ying; Baird, Geoffrey S; Greene, Dina N

2015-12-07

Proper utilization of resources is an important operational objective for clinical laboratories. To reduce unnecessary manual interventions on automated instruments, we conducted a workflow analysis that optimized dilution parameters and reporting of abnormally high chemistry results for the Beckman AU series of chemistry analyzers while maintaining clinically acceptable reportable ranges. Workflow analysis for the Beckman AU680/5812 and DxC800 chemistry analyzers was performed using historical data. Clinical reportable ranges for 53 chemistry analytes were evaluated. Optimized dilution parameters and upper limit of reportable ranges for the AU680/5812 instruments were derived and validated to meet these reportable ranges. The number of specimens that required manual dilutions before and after optimization was determined for both the AU680/5812 and DxC800, with the DxC800 serving as the reference instrument. Retrospective data analysis revealed that 7700 specimens required manual dilutions on the DxC over a 2-y period. Using our optimized AU-specific dilution and reporting parameters, the data-driven simulation analysis showed a 61% reduction in manual dilutions. For the specimens that required manual dilutions on the AU680/5812, we developed standardized dilution procedures to further streamline workflow. We provide a data-driven, practical outline for clinical laboratories to efficiently optimize their use of automated chemistry analyzers. The outcomes can be used to assist laboratories wishing to improve their existing procedures or to facilitate transitioning into a new line of instrumentation, regardless of the instrument model or manufacturer. Copyright © 2015 Elsevier B.V. All rights reserved.

Changing Provider Behavior in the Context of Chronic Disease Management: Focus on Clinical Inertia.

PubMed

Lavoie, Kim L; Rash, Joshua A; Campbell, Tavis S

2017-01-06

Widespread acceptance of evidence-based medicine has led to the proliferation of clinical practice guidelines as the primary mode of communicating current best practices across a range of chronic diseases. Despite overwhelming evidence supporting the benefits of their use, there is a long history of poor uptake by providers. Nonadherence to clinical practice guidelines is referred to as clinical inertia and represents provider failure to initiate or intensify treatment despite a clear indication to do so. Here we review evidence for the ubiquity of clinical inertia across a variety of chronic health conditions, as well as the organizational and system, patient, and provider factors that serve to maintain it. Limitations are highlighted in the emerging literature examining interventions to reduce clinical inertia. An evidence-based framework to address these limitations is proposed that uses behavior change theory and advocates for shared decision making and enhanced guideline development and dissemination.

The use of instant medical history in a rural clinic. Case study of the use of computers in an Arkansas physician's office.

PubMed

Pierce, B

2000-05-01

This study evaluated the acceptance of using computers to take a medical history by rural Arkansas patients. Sex, age, race, education, previous computer experience and owning a computer were used as variables. Patients were asked a series of questions to rate their comfort level with using a computer to take their medical history. Comfort ratings ranged from 30 to 45, with a mean of 36.8 (SEM = 0.67). Neither sex, race, age, education, owning a personal computer, nor prior computer experience had a significant effect on the comfort rating. This study helps alleviate one of the concerns--patient acceptance--about the increasing use of computers in practicing medicine.

Is the NIHSS Certification Process Too Lenient?

PubMed Central

Hills, Nancy K.; Josephson, S. Andrew; Lyden, Patrick D.; Johnston, S. Claiborne

2009-01-01

Background and Purpose The National Institutes of Health Stroke Scale (NIHSS) is a widely used measure of neurological function in clinical trials and patient assessment; inter-rater scoring variability could impact communications and trial power. The manner in which the rater certification test is scored yields multiple correct answers that have changed over time. We examined the range of possible total NIHSS scores from answers given in certification tests by over 7,000 individual raters who were certified. Methods We analyzed the results of all raters who completed one of two standard multiple-patient videotaped certification examinations between 1998 and 2004. The range for the correct score, calculated using NIHSS ‘correct answers’, was determined for each patient. The distribution of scores derived from those who passed the certification test then was examined. Results A total of 6,268 raters scored 5 patients on Test 1; 1,240 scored 6 patients on Test 2. Using a National Stroke Association (NSA) answer key, we found that correct total scores ranged from 2 correct scores to as many as 12 different correct total scores. Among raters who achieved a passing score and were therefore qualified to administer the NIHSS, score distributions were even wider, with 1 certification patient receiving 18 different correct total scores. Conclusions Allowing multiple acceptable answers for questions on the NIHSS certification test introduces scoring variability. It seems reasonable to assume that the wider the range of acceptable answers in the certification test, the greater the variability in the performance of the test in trials and clinical practice by certified examiners. Greater consistency may be achieved by deriving a set of ‘best’ answers through expert consensus on all questions where this is possible, then teaching raters how to derive these answers using a required interactive training module. PMID:19295205

The early economic evaluation of novel biomarkers to accelerate their translation into clinical applications.

PubMed

de Graaf, Gimon; Postmus, Douwe; Westerink, Jan; Buskens, Erik

2018-01-01

Translating prognostic and diagnostic biomarker candidates into clinical applications takes time, is very costly, and many candidates fail. It is therefore crucial to be able to select those biomarker candidates that have the highest chance of successfully being adopted in the clinic. This requires an early estimate of the potential clinical impact and commercial value. In this paper, we aim to demonstratively evaluate a set of novel biomarkers in terms of clinical impact and commercial value, using occurrence of cardiovascular disease (CVD) in type-2 diabetes (DM2) patients as a case study. We defined a clinical application for the novel biomarkers, and subsequently used data from a large cohort study in The Netherlands in a modeling exercise to assess the potential clinical impact and headroom for the biomarkers. The most likely application of the biomarkers would be to identify DM2 patients with a low CVD risk and subsequently withhold statin treatment. As a result, one additional CVD event in every 75 patients may be expected. The expected downstream savings resulted in a headroom for a point-of-care device ranging from €119.09 at a willingness to accept of €0 for one additional CVD event, to €0 at a willingness to accept of €15,614 or more. It is feasible to evaluate novel biomarkers on outcomes directly relevant to technological development and clinical adoption. Importantly, this may be attained at the same point in time and using the same data as used for the evaluation of association with disease and predictive power.

Advances in quantitative UV-visible spectroscopy for clinical and pre-clinical application in cancer.

PubMed

Brown, J Quincy; Vishwanath, Karthik; Palmer, Gregory M; Ramanujam, Nirmala

2009-02-01

Methods of optical spectroscopy that provide quantitative, physically or physiologically meaningful measures of tissue properties are an attractive tool for the study, diagnosis, prognosis, and treatment of various cancers. Recent development of methodologies to convert measured reflectance and fluorescence spectra from tissue to cancer-relevant parameters such as vascular volume, oxygenation, extracellular matrix extent, metabolic redox states, and cellular proliferation have significantly advanced the field of tissue optical spectroscopy. The number of publications reporting quantitative tissue spectroscopy results in the UV-visible wavelength range has increased sharply in the past three years, and includes new and emerging studies that correlate optically measured parameters with independent measures such as immunohistochemistry, which should aid in increased clinical acceptance of these technologies.

Cognitive behaviour therapy for long-term frequent attenders in primary care: a feasibility case series and treatment development study.

PubMed

Malins, Samuel; Kai, Joe; Atha, Christopher; Avery, Anthony; Guo, Boliang; James, Marilyn; Patel, Shireen; Sampson, Christopher; Stubley, Michelle; Morriss, Richard

2016-10-01

Most frequent attendance in primary care is temporary. Long-term frequent attendance may be suitable for psychological intervention to address health management and service use. To explore the feasibility and acceptability of cognitive behaviour therapy (CBT) for long-term frequent attendance in primary care and obtain preliminary evidence regarding clinical and cost effectiveness. A CBT case series was carried out in five GP practices in the East Midlands. Frequent attenders (FAs) were identified from case notes and invited by their practice for assessment, then offered CBT. Feasibility and acceptability were assessed by CBT session attendance and thematic analysis of semi-structured questionnaires. Clinical and cost effectiveness was assessed by primary care use and clinically important change on a range of health and quality of life instruments. Of 462 FAs invited to interview, 87 (19%) consented to assessment. Thirty-two (7%) undertook CBT over a median of 3 months. Twenty-four (75%) attended at least six sessions. Eighteen FAs (86%, n = 21) reported overall satisfaction with treatment. Patients reported valuing listening without judgement alongside support to develop coping strategies. Thirteen (54%, n = 24), achieved clinically important improvement on the SF-36 Mental-Component Scale at 6-month follow-up and improved quality of life, but no improvement on other outcomes. Primary care use reduced from a median of eight contacts in 3 months at baseline (n = 32) to three contacts in 3 months at 1 year (n = 18). CBT appears feasible and acceptable to a subset of long-term FAs in primary care who halved their primary care use. With improved recruitment strategies, this approach could contribute to decreasing GP workload and merits larger-scale evaluation. © British Journal of General Practice 2016.

Kangaroo mother care for clinically unstable neonates weighing ≤2000 g: Is it feasible at a hospital in Uganda?

PubMed

Morgan, Melissa C; Nambuya, Harriet; Waiswa, Peter; Tann, Cally; Elbourne, Diana; Seeley, Janet; Allen, Elizabeth; Lawn, Joy E

2018-06-01

Kangaroo mother care (KMC) for stable neonates ≤2000 g (g) is associated with decreased mortality, sepsis, hypothermia, and length of stay compared to conventional care. The World Health Organization states that KMC "should be initiated… as soon as newborns are clinically stable " [12]. However, the majority of deaths occur in unstable neonates. We aimed to determine the proportion of admitted neonates meeting proposed instability criteria, assess the feasibility of providing KMC to unstable neonates, and evaluate the acceptability of this intervention to parents and providers at Jinja Regional Referral Hospital in Uganda. This was a mixed-methods study. We recorded data including birthweight, chronological age, and treatments administered from medical charts, and calculated the percentage of clinically unstable neonates, defined as the need for ≥2 medical therapies in the first 48 hours of admission. We enrolled a sample of neonates meeting pre-defined instability criteria. Mothers were counselled to provide KMC as close to continuously as possible. We calculated the median duration of KMC per episode and per day. To explore acceptability, we conducted semi-structured interviews with parents and newborn unit care providers, and analysed data using the thematic content approach. We included 254 neonates in the audit, 10 neonates in the feasibility sub-study, and 20 participants in the acceptability sub-study. Instability criteria were easily implementable, identifying 89% of neonates as unstable in the audit. The median duration of individual KMC episodes ranged from 115 to 134 minutes. The median daily duration ranged from 4.5 to 9.7 hours. Seventy-five percent of interviewees felt KMC could be used in neonates concurrently receiving other medical therapies. Barriers included lack of resources (beds/space, monitoring devices), privacy issues, inadequate education, and difficulties motivating mothers to devote time to KMC. Recommendations included staff/peer counselling, resources, family support, and community outreach. There remains a need for an evidence-based approach to consistently define stability criteria for KMC to improve care. We found that KMC for unstable neonates weighing ≤2000g was feasible and acceptable at Jinja Hospital in Uganda. Randomised controlled trials are needed to demonstrate the effect of KMC on survival among unstable neonates in low-resource settings.

Kangaroo mother care for clinically unstable neonates weighing ≤2000 g: Is it feasible at a hospital in Uganda?

PubMed Central

Morgan, Melissa C; Nambuya, Harriet; Waiswa, Peter; Tann, Cally; Elbourne, Diana; Seeley, Janet; Allen, Elizabeth; Lawn, Joy E

2018-01-01

Background Kangaroo mother care (KMC) for stable neonates ≤2000 g (g) is associated with decreased mortality, sepsis, hypothermia, and length of stay compared to conventional care. The World Health Organization states that KMC “should be initiated… as soon as newborns are clinically stable” [12]. However, the majority of deaths occur in unstable neonates. We aimed to determine the proportion of admitted neonates meeting proposed instability criteria, assess the feasibility of providing KMC to unstable neonates, and evaluate the acceptability of this intervention to parents and providers at Jinja Regional Referral Hospital in Uganda. Methods This was a mixed-methods study. We recorded data including birthweight, chronological age, and treatments administered from medical charts, and calculated the percentage of clinically unstable neonates, defined as the need for ≥2 medical therapies in the first 48 hours of admission. We enrolled a sample of neonates meeting pre-defined instability criteria. Mothers were counselled to provide KMC as close to continuously as possible. We calculated the median duration of KMC per episode and per day. To explore acceptability, we conducted semi-structured interviews with parents and newborn unit care providers, and analysed data using the thematic content approach. Findings We included 254 neonates in the audit, 10 neonates in the feasibility sub-study, and 20 participants in the acceptability sub-study. Instability criteria were easily implementable, identifying 89% of neonates as unstable in the audit. The median duration of individual KMC episodes ranged from 115 to 134 minutes. The median daily duration ranged from 4.5 to 9.7 hours. Seventy-five percent of interviewees felt KMC could be used in neonates concurrently receiving other medical therapies. Barriers included lack of resources (beds/space, monitoring devices), privacy issues, inadequate education, and difficulties motivating mothers to devote time to KMC. Recommendations included staff/peer counselling, resources, family support, and community outreach. Conclusions There remains a need for an evidence-based approach to consistently define stability criteria for KMC to improve care. We found that KMC for unstable neonates weighing ≤2000g was feasible and acceptable at Jinja Hospital in Uganda. Randomised controlled trials are needed to demonstrate the effect of KMC on survival among unstable neonates in low-resource settings. PMID:29497509

LGBT Youth and Family Acceptance

PubMed Central

Katz-Wise, Sabra L.; Rosario, Margaret; Tsappis, Michael

2016-01-01

Summary In this article, we address theories of attachment and parental acceptance and rejection, and their implications for lesbian, gay, bisexual, and transgender (LGBT) youths’ identity and health. We also provide two clinical cases to illustrate the process of family acceptance of a transgender youth and a gender nonconforming youth who was neither a sexual minority nor transgender. Clinical implications of family acceptance and rejection of LGBT youth are discussed. PMID:27865331

The relationships between father involvement and parental acceptance on the psychological adjustment of children and adolescents: The moderating effects of clinical status.

PubMed

Rodríguez Ruiz, Mercedes; Holgado-Tello, Francisco Pablo; Carrasco, Miguel Ángel

2017-10-01

This study analyzes how a child's clinical condition modifies the relationship of father involvement, parental (fathers and mothers) acceptance and the child´s psychological adjustment, including the internalizing and externalizing problems. The cohort studied was composed of 226 subjects (61.94% males) with a mean age of 14.08 years, of which 113 children were from an incidental clinical sample and 113 from the general population. Both groups were matched by sex, age and family status, and the data show that the same structure of parent-child relationships that predict the child´s psychological adjustment can be accepted for both the clinical and non-clinical groups of children. However, the intensity of the relationships between the variables father involvement, parental acceptance and the child´s outcomes differed in function of the child's clinical status. Specifically, in the clinically-referred sample compared to non-clinical sample father involvement had a stronger effect on the children´s internalizing (but not the externalizing) problems and on their global psychological adjustment via their perceived maternal acceptance. The role of father involvement in the family relationships of clinical children is discussed. This study provides important evidence to support the need for enhanced paternal participation in the intervention programs for families. Copyright © 2017 Elsevier B.V. All rights reserved.

Lessons Learned During the Conduct of Clinical Studies in The Dental PBRN

PubMed Central

Gilbert, Gregg H.; Richman, Joshua S.; Gordan, Valeria V.; Rindal, D. Brad; Fellows, Jeffrey L.; Benjamin, Paul L.; Wallace-Dawson, Martha; Williams, O. Dale

2012-01-01

Effectively addressing challenges of conducting research in nonacademic settings is crucial to its success. A dental practice-based research network called The Dental Practice-Based Research Network (DPBRN) is comprised of practitioner-investigators in two health maintenance organizations, several universities, many U.S. states, and three Scandinavian countries. Our objective in this article is to describe lessons learned from conducting studies in this research context; the studies are conducted by clinicians in community settings who may be doing their first research study. To date, twenty-one studies have been completed or are in implementation. These include a broad range of topic areas, enrollment sizes, and study designs. A total of 1,126 practitioner-investigators have participated in at least one study. After excluding one study because it involved electronic records queries only, these studies included more than 70,000 patient/participant units. Because the DPBRN is committed to being both practitioner- and patient-driven, all studies must be approved by its Executive Committee and a formal study section of academic clinical scientists. As a result of interacting with a diverse range of institutional and regulatory entities, funding agencies, practitioners, clinic staff, patients, academic scientists, and geographic areas, twenty-three key lessons have been learned. Patients’ acceptance of these studies has been very high, judging from high participation rates and their completion of data forms. Early studies substantially informed later studies with regard to study design, practicality, forms design, informed consent process, and training and monitoring methods. Although time-intensive and complex, these solutions improved acceptability of practice-based research to patients, practitioners, and university researchers. PMID:21460266

Clinical Application of Diode Laser (980 nm) in Maxillofacial Surgical Procedures.

PubMed

Aldelaimi, Tahrir N; Khalil, Afrah A

2015-06-01

For many procedures, lasers are now becoming the treatment of choice by both clinicians and patients, and in some cases, the standard of care. This clinical study was carried out at Department of Maxillofacial Surgery, Ramadi Teaching Hospital, Rashid Private Hospital and Razi Private Hospital, Anbar Health Directorate, Anbar Province, Iraq. A total of 32 patients including 22 (≈ 70%) male and 10 (≈ 30%) female with age range from 5 months to 34 years old. Chirolas 20 W diode laser emitting at 980 nm was used. Our preliminary clinical findings include sufficient hemostasis, coagulation properties, precise incision margin, lack of swelling, bleeding, pain, scar tissue formation and overall satisfaction were observed in the clinical application. The clinical application of the diode (980 nm) laser in maxillofacial surgery proved to be of beneficial effect for daily practice and considered practical, effective, easy to used, offers a safe, acceptable, and impressive alternative for conventional surgical techniques.

The laboratory diagnosis of testosterone deficiency.

PubMed

Paduch, Darius A; Brannigan, Robert E; Fuchs, Eugene F; Kim, Edward D; Marmar, Joel L; Sandlow, Jay I

2014-05-01

The evaluation and treatment of hypogonadal men has become an important part of urologic practice. Fatigue, loss of libido, and erectile dysfunction are commonly reported, but nonspecific symptoms and laboratory verification of low testosterone (T) are an important part of evaluation in addition to a detailed history and physical examination. Significant intraindividual fluctuations in serum T levels, biologic variation of T action on end organs, the wide range of T levels in human serum samples, and technical limitations of currently available assays have led to poor reliability of T measurements in the clinical laboratory setting. There is no universally accepted threshold of T concentration that distinguishes eugonadal from hypogonadal men; thus, laboratory results have to be interpreted in the appropriate clinical setting. This review focuses on clinical, biological, and technological challenges that affect serum T measurements to educate clinicians regarding technological advances and limitations of the currently available laboratory methods to diagnose hypogonadism. A collaborative effort led by the American Urological Association between practicing clinicians, patient advocacy groups, government regulatory agencies, industry, and professional societies is underway to provide optimized assay platforms and evidence-based normal assay ranges to guide clinical decision making. Until such standardization is commonplace in clinical laboratories, the decision to treat should be based on the presence of signs and symptoms in addition to serum T measurements. Rigid interpretation of T ranges should not dictate clinical decision making or define coverage of treatment by third party payers. Copyright © 2014 Elsevier Inc. All rights reserved.

Impacts of in utero and early infant taste experiences on later taste acceptance: a systematic review.

PubMed

Nehring, Ina; Kostka, Tanja; von Kries, Rüdiger; Rehfuess, Eva A

2015-06-01

Dietary behavior exerts a critical influence on health and is the outcome of a broad range of interacting factors, including food and taste acceptance. These may be programmed in utero and during early infancy. We examined the hypothesis that fetuses and infants exposed to sweet, salty, sour, bitter, umami, or specific tastes show greater acceptance of that same taste later in life. We conducted a systematic review of the literature, using comprehensive searches and following established procedures for screening, data extraction, and quality appraisal. We used harvest plots to synthesize the evidence graphically. Twenty studies comprising 38 subgroups that differed by taste, age, medium, and duration of exposure were included. Exposure to bitter and specific tastes increased the acceptance of these tastes. Studies on sweet and salty tastes showed equivocal results. Studies on sour tastes were sparse. Our systematic review clearly shows programming of the acceptance of bitter and specific tastes. For other tastes the results were either equivocal or confined to a few number of studies that precluded us from drawing conclusions. Further research should examine the association of salty and sour taste exposures on later preferences of these tastes. Long-term studies and randomized clinical trials on each type of taste are needed. © 2015 American Society for Nutrition.

Single-centre study of the diagnostic performance of plasma metanephrines with seated sampling for the diagnosis of phaeochromocytoma/paraganglioma.

PubMed

Boot, Christopher; Toole, Barry; Johnson, Sarah J; Ball, Stephen; Neely, Dermot

2017-01-01

Background Measurement of plasma metanephrines is regarded as one of the best screening tests for phaeochromocytoma/paraganglioma. Current guidelines recommend that samples are ideally collected in the supine position after 30 min rest and interpreted using supine reference ranges, in order to optimize the diagnostic performance of the test. Current practice in our centre is to collect samples for plasma metanephrines from seated patients. The aim of the study was to determine, if seated sampling for plasma metanephrines provides acceptable diagnostic performance in our centre. Methods Clinical and laboratory data of 113 patients, gathered over a four-year period 2010-2014, were reviewed. All had undergone preoperative plasma metanephrines measurement and had postoperative histopathology confirmation or exclusion of phaeochromocytoma/paraganglioma. Results Of 113 patients included in the study, 40 had a histological diagnosis of phaeochromocytoma/paraganglioma. The remaining 73 patients had an alternative adrenal pathology. The diagnostic sensitivity of normetanephrine or metanephrine above the upper limit of our in-house seated reference range was 93%. However, excluding three cases of paraganglioma determined clinically and biochemically to be non-functional raised the sensitivity to 100%. Diagnostic specificity was 90%. Applying published supine reference ranges made no difference to diagnostic sensitivity in this group of patients but decreased diagnostic specificity to 75%. Conclusions While these data are derived from a relatively small study population, they demonstrate acceptable diagnostic performance for seated plasma metanephrines as a screening test for phaeochromocytoma/paraganglioma. These data highlight a high diagnostic sensitivity for plasma metanephrines with seated sampling in our centre.

Feasibility and Acceptability of a Colocated Homeless-Tailored Primary Care Clinic and Emergency Department.

PubMed

Gabrielian, Sonya; Chen, Jennifer C; Minhaj, Beena P; Manchanda, Rishi; Altman, Lisa; Koosis, Ella; Gelberg, Lillian

2017-10-01

Homeless adults have low primary care engagement and high emergency department (ED) utilization. Homeless-tailored, patient-centered medical homes (PCMH) decrease this population's acute care use. We studied the feasibility (focused on patient recruitment) and acceptability (conceptualized as clinicians' attitudes/beliefs) of a pilot initiative to colocate a homeless-tailored PCMH with an ED. After ED triage, low-acuity patients appropriate for outpatient care were screened for homelessness; homeless patients chose between a colocated PCMH or ED visit. To study feasibility, we captured (from May to September 2012) the number of patients screened for homelessness, positive screens, unique patients seen, and primary care visits. We focused on acceptability to ED clinicians (physicians, nurses, social workers); we sent a 32-item survey to ED clinicians (n = 57) who worked during clinic hours. Questions derived from an instrument measuring clinician attitudes toward homeless persons; acceptability of homelessness screening and the clinic itself were also explored. Over the 5 months of interest, 281 patients were screened; 172 (61.2%) screened positive for homelessness; 112 (65.1%) of these positive screens were seen over 215 visits. Acceptability data were obtained from 56% (n = 32) of surveyed clinicians. Attitudes toward homeless patients were similar to prior studies of primary care physicians. Most (54.6%) clinicians agreed with the homelessness screening procedures. Nearly all (90.3%) clinicians supported expansion of the homeless-tailored clinic; a minority (42.0%) agreed that ED colocation worked well. Our data suggest the feasibility of recruiting patients to a homeless-tailored primary care clinic colocated with the ED; however, the clinic's acceptability was mixed. Future quality improvement work should focus on tailoring the clinic to increase its acceptability among ED clinicians, while assessing its impact on health, housing, and costs.

Organic electrochemical transistor based immunosensor for prostate specific antigen (PSA) detection using gold nanoparticles for signal amplification.

PubMed

Kim, Duck-Jin; Lee, Nae-Eung; Park, Joon-Shik; Park, In-Jun; Kim, Jung-Gu; Cho, Hyoung J

2010-07-15

We demonstrated a highly sensitive organic electrochemical transistor (OECT) based immunosensor with a low detection limit for prostate specific antigen/alpha1-antichymotrypsin (PSA-ACT) complex. The poly(styrenesulfonate) doped poly(3,4-ethylenedioxythiophene) (PEDOT:PSS) based OECT with secondary antibody conjugated gold nanoparticles (AuNPs) provided a detection limit of the PSA-ACT complex as low as 1pg/ml, as well as improved sensitivity and a dynamic range, due to the role of AuNPs in the signal amplification. The sensor performances were particularly improved in the lower concentration range where the detection is clinically important for the preoperative diagnosis and screening of prostate cancer. This result shows that the OECT-based immunosensor can be used as a transducer platform acceptable to the point-of-care (POC) diagnostic systems and demonstrates adaptability of organic electronics to clinical applications. Copyright (c) 2010 Elsevier B.V. All rights reserved.

Promoting excellence in end-of-life care: a report on innovative models of palliative care.

PubMed

Byock, Ira; Twohig, Jeanne Sheils; Merriman, Melanie; Collins, Karyn

2006-02-01

Promoting Excellence in End-of Life Care, a national program of The Robert Wood Johnson Foundation, funded 22 demonstration projects representing a wide range of health care settings and patient populations to develop innovative models for delivering palliative care that addressed documented deficiencies in the care of patients and families facing the final stage of life. To determine the practicality (feasibility of development and operation as well as acceptance by stakeholders) of new models of care and to determine the impact of the models on access to, quality of and financing for palliative care. The program cannot report scientifically rigorous outcomes, but the grant-funded projects used a variety of methods and measures to assess acceptance of new models and their impact from the perspectives of various stakeholders, including patients and their families, clinicians, administrators and payers. While it is not possible to aggregate data across projects, the data reported to the Promoting Excellence national program office were used to describe program impact with respect to the practicality of palliative care service integration into existing clinical care settings (feasibility and acceptance by stakeholders), the availability and use of palliative care services (access), quality of care (conformance to patient expectations and accepted clinical standards) and costs of care. The 22 projects provided services in urban as well as rural settings, in integrated health systems, hospitals, outpatient clinics, cancer centers, nursing homes, renal dialysis clinics, inner city public health and safety net systems and prisons. Populations served included prison inmates, military veterans, renal dialysis patients, Native Americans, Native Alaskans, and African American patients, inner-city medically underserved patients, pediatric patients, and persons with serious mental illness patients. Hosting or adopting institutions sustained or expanded twenty of the 22 models, and feedback from all stakeholders was positive. Project sites developed and utilized new palliative care services and addressed quality through implementation of new standards and clinical protocols. Costs of care, where they could be assessed, were unaffected or decreased for project patients versus historical or concurrent controls. The 22 Promoting Excellence in End-of Life Care projects demonstrated that by individualizing patient and family assessment, effectively employing existing resources and aligning services with specific patient and family needs, it is possible to expand access to palliative services and improve quality of care in ways that are financially feasible and acceptable to patients, families, clinicians, administrators, and payers.

Porcelain thickness and cement shade effects on the colour and translucency of porcelain veneering materials.

PubMed

Kürklü, Duygu; Azer, Shereen S; Yilmaz, Burak; Johnston, William M

2013-11-01

Purposes of this in vitro study include evaluating colour changes in combinations of feldspathic porcelain and cement resulting from different thicknesses of porcelain and different shades of composite luting agent, and evaluating relative translucency parameter (RTP) values. Porcelain discs of shade A1 at nominal thicknesses of 0.5 and 1.0mm were bonded to cements of three shades in a factorial design. Colours were calculated for CIE D65 Illuminant and Standard Human Observer on black, grey and white backings. A colour difference (CD) was calculated of each possible pair of different porcelain thickness values for the same cement shade and each possible pair of different cement shades for the same porcelain thickness. RTP was analyzed by ANOVA and selected pairwise comparisons. All mean CDs studied were perceptible and most were at or greater than the clinical acceptability threshold, with the notable exception that the mean CDs and their confidence limits were below the clinical acceptability threshold for a change in porcelain thickness when utilizing the Clear cement shade. Variation in the shade of the resin luting cement will result in CDs which are near or beyond clinical acceptability. A decrease in porcelain thickness did significantly increase RTP when bonded to the resin cement shades studied. Changes in porcelain thickness or cement shade may adversely affect basic aesthetic properties of these materials. Development of methods for analyzing aesthetic effects over greater ranges of thickness for these materials would improve the prognosis for using these materials. Copyright © 2013 Elsevier Ltd. All rights reserved.

Usability, Acceptability, and Impact of a Pediatric Teledermatology Mobile Health Application.

PubMed

Fiks, Alexander G; Fleisher, Linda; Berrigan, Lindsay; Sykes, Emily; Mayne, Stephanie L; Gruver, Rachel; Halkyard, Katherine; Jew, Olivia S; FitzGerald, Patrick; Winston, Flaura; McMahon, Patrick

2018-03-01

Pediatric dermatology appointment wait times often exceed several months. We evaluated the usability, acceptability, and clinical impact of a store-and-forward teledermatology mobile application (app) linking families with pediatric dermatologists. Parents of children age 6 weeks to 17 years or individuals 18-21 years old were invited (by e-mail or referral) to participate in this single group, prospective study. Within the app, users photographed the skin condition, answered questions, and submitted their case for review. One pediatric dermatologist viewed cases, diagnosed conditions, and provided instructions and prescriptions. User surveys immediately following app use and 1 week later, supplemented by electronic logs, assessed usability, acceptability, and impact. One hundred ninety-seven parents and one adolescent submitted cases within 39 days of invitation. App users were more likely to be white than those in the population invited (67% vs. 34%, p < 0.001) and their children were slightly younger (mean 7.3 vs. 9.0 years, p < 0.001). A majority, 83% found the app easy to use, 97% felt that submitting a case took "the right amount of time," 87% were satisfied, and 93% would use the app again. Prescription receipt was associated with increased app satisfaction (p = 0.008). The median user received a response in 2.8 h (interquartile range 1.1-6.4). Had the app been unavailable, 44% reported that they would have waited for primary care, 32% for a dermatology appointment, and 7% would have gone to an urgent care clinic. A mobile health app allowing families to directly consult a pediatric dermatologist was usable, acceptable, and expedited care.

Treatment of Pediatric Obsessive Compulsive Disorder Utilizing Parent-Facilitated Acceptance and Commitment Therapy

ERIC Educational Resources Information Center

Barney, Jennifer Y.; Field, Clint E.; Morrison, Kate L.; Twohig, Michael P.

2017-01-01

Acceptance and commitment therapy (ACT) is a modern form of cognitive behavior therapy that uses acceptance and mindfulness-based procedures to address clinical issues. A brief protocol of ACT was used with 3 children ages 10 and 11 years who were diagnosed with obsessive compulsive disorder (OCD). Results showed notable and clinically significant…

Perceptions of the Acceptability of Parent Training among Chinese Immigrant Parents: Contributions of Cultural Factors and Clinical Need

ERIC Educational Resources Information Center

Ho, Judy; Yeh, May; McCabe, Kristen; Lau, Anna

2012-01-01

Parent training (PT) is well established for reducing child externalizing problems; however, lower rates of engagement in PT among ethnic minority/immigrant families have been found. We assessed PT acceptability among Chinese immigrant parents and explored clinical and cultural factors that may be associated with acceptability. Participants were a…

CT protocol management: simplifying the process by using a master protocol concept.

PubMed

Szczykutowicz, Timothy P; Bour, Robert K; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N

2015-07-08

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two-tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade-offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be adapted among different clinical indications on a single scanner and among different CT scanners.

A New Clinical Pain Knowledge Test for Nurses: Development and Psychometric Evaluation.

PubMed

Bernhofer, Esther I; St Marie, Barbara; Bena, James F

2017-08-01

All nurses care for patients with pain, and pain management knowledge and attitude surveys for nurses have been around since 1987. However, no validated knowledge test exists to measure postlicensure clinicians' knowledge of the core competencies of pain management in current complex patient populations. To develop and test the psychometric properties of an instrument designed to measure pain management knowledge of postlicensure nurses. Psychometric instrument validation. Four large Midwestern U.S. hospitals. Registered nurses employed full time and part time August 2015 to April 2016, aged M = 43.25 years; time as RN, M = 16.13 years. Prospective survey design using e-mail to invite nurses to take an electronic multiple choice pain knowledge test. Content validity of initial 36-item test "very good" (95.1% agreement). Completed tests that met analysis criteria, N = 747. Mean initial test score, 69.4% correct (range 27.8-97.2). After revision/removal of 13 unacceptable questions, mean test score was 50.4% correct (range 8.7-82.6). Initial test item percent difficulty range was 15.2%-98.1%; discrimination values range, 0.03-0.50; final test item percent difficulty range, 17.6%-91.1%, discrimination values range, -0.04 to 1.04. Split-half reliability final test was 0.66. A high decision consistency reliability was identified, with test cut-score of 75%. The final 23-item Clinical Pain Knowledge Test has acceptable discrimination, difficulty, decision consistency, reliability, and validity in the general clinical inpatient nurse population. This instrument will be useful in assessing pain management knowledge of clinical nurses to determine gaps in education, evaluate knowledge after pain management education, and measure research outcomes. Copyright © 2017 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Rheology of tissue conditioners.

PubMed

Murata, H; Hamada, T; Djulaeha, E; Nikawa, H

1998-02-01

Tissue conditioners can be used to condition abused tissues, record functional impressions, make temporary relinings, and for other clinical applications, mainly because of their specific viscoelasticity. However, little information is available on the rheology of the materials, manipulation, and suitability for various clinical applications. This study evaluated the gelation times, the viscoelastic properties after gelation of tissue conditioners, and the influence of the powder/liquid (P/L) ratio. Ten tissue conditioners were used and gelation times were obtained with an oscillating rheometer. A series of stress relaxation tests were also conducted to evaluate the viscoelastic properties after gelation and the changes with the passage of time by means of Maxwell model analogies. Significant differences were found in the gelation times and flow properties after gelation among the materials mixed with the P/L ratios recommended by the manufacturers. The flow properties tended to increase with time of storage. Large differences in the limits of the clinically acceptable P/L ratios and the adjustable limits of elasticity and viscosity by altering P/L ratios were found among the materials. The results suggested that each material should be selected according to each clinical purpose because of the wide ranges of viscoelastic properties and changes in viscoelasticity with time among the materials. Furthermore, gelation times and the viscoelastic properties after gelation can be controlled to improve handling and suit various applications by altering the P/L ratios within the acceptable limits.

Evaluation of the implementation of a clinical pharmacy service on an acute internal medicine ward in Italy.

PubMed

Lombardi, Nicola; Wei, Li; Ghaleb, Maisoon; Pasut, Enrico; Leschiutta, Silvia; Rossi, Paolo; Troncon, Maria Grazia

2018-04-10

Successful implementation of clinical pharmacy services is associated with improvement of appropriateness of prescribing. Both high clinical significance of pharmacist interventions and their high acceptance rate mean that potential harm to patients could be avoided. Evidence shows that low acceptance rate of pharmacist interventions can be associated with lack of communication between pharmacists and the rest of the healthcare team. The objective of this study was to evaluate the effect of a structured communication strategy on acceptance rate of interventions made by a clinical pharmacist implementing a ward-based clinical pharmacy service targeting elderly patients at high risk of drug-related problems. Characteristics of interventions made to improve appropriateness of prescribing, their clinical significance and intervention acceptance rate by doctors were recorded. A clinical pharmacy intervention study was conducted between September 2013 and December 2013 in an internal medicine ward of a teaching hospital. A trained clinical pharmacist provided pharmaceutical care to 94 patients aged over 70 years. The clinical pharmacist used the following communication and marketing tools to implement the service described: Strengths, Weaknesses, Opportunities and Threats (SWOT) analysis; Specific, Measurable, Achievable, Realistic and Timely (SMART) goals; Awareness, Interest, Desire, Action (AIDA) model. A total of 740 interventions were made by the clinical pharmacist. The most common drug classes involved in interventions were: antibacterials for systemic use (11.1%) and anti-parkinson drugs (10.8%). The main drug-related problem categories triggering interventions were: no specific problem (15.9%) and prescription writing error (12.0%). A total of 93.2% of interventions were fully accepted by physicians. After assessment by an external panel 63.2% of interventions (96 interventions/ per month) were considered of moderate clinical significance and 23.4% (36 interventions/ per month) of major clinical significance. The most frequent interventions were to educate a healthcare professional (20.4%) and change dose (16.1%). To our knowledge this is the first study evaluating the effect of a structured communication strategy on acceptance rate of pharmacist interventions. Pharmaceutical care delivered by the clinical pharmacist is likely to have had beneficial outcomes. Clinical pharmacy services like the one described should be implemented widely to increase patient safety.

Systematic review of social media interventions for smoking cessation.

PubMed

Naslund, John A; Kim, Sunny Jung; Aschbrenner, Kelly A; McCulloch, Laura J; Brunette, Mary F; Dallery, Jesse; Bartels, Stephen J; Marsch, Lisa A

2017-10-01

Popular social media could extend the reach of smoking cessation efforts. In this systematic review, our objectives were: 1) to determine whether social media interventions for smoking cessation are feasible, acceptable, and potentially effective; 2) to identify approaches for recruiting subjects; and 3) to examine the specific intervention design components and strategies employed to promote user engagement and retention. We searched Scopus, Medline, EMBASE, Cochrane Central, PsychINFO, CINAHL, and Web of Science through July 2016 and reference lists of relevant articles. Included studies described social media interventions for smoking cessation and must have reported outcomes related to feasibility, acceptability, usability, or smoking-related outcomes. We identified 7 studies (all were published since 2014) that enrolled 9755 participants (median=136 [range 40 to 9042]). Studies mainly used Facebook (n=4) or Twitter (n=2), and emerged as feasible and acceptable. Five studies reported smoking-related outcomes such as greater abstinence, reduction in relapse, and an increase in quit attempts. Most studies (n=6) recruited participants using online or Facebook advertisements. Tailored content, targeted reminders, and moderated discussions were used to promote participant engagement. Three studies found that active participation through posting comments or liking content may be associated with improved outcomes. Retention ranged from 35% to 84% (median=70%) across the included studies. Our review highlights the feasibility, acceptability and preliminary effectiveness of social media interventions for smoking cessation. Future research should continue to explore approaches for promoting user engagement and retention, and whether sustained engagement translates to clinically meaningful smoking cessation outcomes. Copyright © 2017. Published by Elsevier Ltd.

Application of laser Raman spectroscopy in concentration measurements of multiple analytes in human body fluids

NASA Astrophysics Data System (ADS)

Qu, Jianan Y.; Suria, David; Wilson, Brian C.

1998-05-01

The primary goal of these studies was to demonstrate that NIR Raman spectroscopy is feasible as a rapid and reagentless analytic method for clinical diagnostics. Raman spectra were collected on human serum and urine samples using a 785 nm excitation laser and a single-stage holographic spectrometer. A partial east squares method was used to predict the analyte concentrations of interest. The actual concentrations were determined by a standard clinical chemistry. The prediction accuracy of total protein, albumin, triglyceride and glucose in human sera ranged from 1.5 percent to 5 percent which is greatly acceptable for clinical diagnostics. The concentration measurements of acetaminophen, ethanol and codeine inhuman urine have demonstrated the potential of NIR Raman technology in screening of therapeutic drugs and substances of abuse.

Histogram Matching Extends Acceptable Signal Strength Range on Optical Coherence Tomography Images

PubMed Central

Chen, Chieh-Li; Ishikawa, Hiroshi; Wollstein, Gadi; Bilonick, Richard A.; Sigal, Ian A.; Kagemann, Larry; Schuman, Joel S.

2015-01-01

Purpose. We minimized the influence of image quality variability, as measured by signal strength (SS), on optical coherence tomography (OCT) thickness measurements using the histogram matching (HM) method. Methods. We scanned 12 eyes from 12 healthy subjects with the Cirrus HD-OCT device to obtain a series of OCT images with a wide range of SS (maximal range, 1–10) at the same visit. For each eye, the histogram of an image with the highest SS (best image quality) was set as the reference. We applied HM to the images with lower SS by shaping the input histogram into the reference histogram. Retinal nerve fiber layer (RNFL) thickness was automatically measured before and after HM processing (defined as original and HM measurements), and compared to the device output (device measurements). Nonlinear mixed effects models were used to analyze the relationship between RNFL thickness and SS. In addition, the lowest tolerable SSs, which gave the RNFL thickness within the variability margin of manufacturer recommended SS range (6–10), were determined for device, original, and HM measurements. Results. The HM measurements showed less variability across a wide range of image quality than the original and device measurements (slope = 1.17 vs. 4.89 and 1.72 μm/SS, respectively). The lowest tolerable SS was successfully reduced to 4.5 after HM processing. Conclusions. The HM method successfully extended the acceptable SS range on OCT images. This would qualify more OCT images with low SS for clinical assessment, broadening the OCT application to a wider range of subjects. PMID:26066749

Using Mindfulness- and Acceptance-Based Treatments with Clients from Nondominant Cultural and/or Marginalized Backgrounds: Clinical Considerations, Meta-Analysis Findings, and Introduction to the Special Series--Clinical Considerations in Using Acceptance- and Mindfulness-Based Treatments with Diverse Populations

ERIC Educational Resources Information Center

Fuchs, Cara; Lee, Jonathan K.; Roemer, Lizabeth; Orsillo, Susan M.

2013-01-01

A growing body of research suggests that mindfulness- and acceptance-based principles can increase efforts aimed at reducing human suffering and increasing quality of life. A critical step in the development and evaluation of these new approaches to treatment is to determine the acceptability and efficacy of these treatments for clients from…

Development and validation of effective real-time and periodic interinstrument comparison method for automatic hematology analyzers.

PubMed

Park, Sang Hyuk; Park, Chan-Jeoung; Kim, Mi-Jeong; Choi, Mi-Ok; Han, Min-Young; Cho, Young-Uk; Jang, Seongsoo

2014-12-01

We developed and validated an interinstrument comparison method for automatic hematology analyzers based on the 99th percentile coefficient of variation (CV) cutoff of daily means and validated in both patient samples and quality control (QC) materials. A total of 120 patient samples were obtained over 6 months. Data from the first 3 months were used to determine 99th percentile CV cutoff values, and data obtained in the last 3 months were used to calculate acceptable ranges and rejection rates. Identical analyses were also performed using QC materials. Two instrument comparisons were also performed, and the most appropriate allowable total error (ATE) values were determined. The rejection rates based on the 99th percentile cutoff values were within 10.00% and 9.30% for the patient samples and QC materials, respectively. The acceptable ranges of QC materials based on the currently used method were wider than those calculated from the 99th percentile CV cutoff values in most items. In two-instrument comparisons, 34.8% of all comparisons failed, and 87.0% of failed comparisons were successful when 4 SD was applied as an ATE value instead of 3 SD. The 99th percentile CV cutoff value-derived daily acceptable ranges can be used as a real-time interinstrument comparison method in both patient samples and QC materials. Applying 4 SD as an ATE value can significantly reduce unnecessarily followed recalibration in the leukocyte differential counts, reticulocytes, and mean corpuscular volume. Copyright© by the American Society for Clinical Pathology.

Feasibility and Acceptability of a Colocated Homeless-Tailored Primary Care Clinic and Emergency Department

PubMed Central

Gabrielian, Sonya; Chen, Jennifer C.; Minhaj, Beena P.; Manchanda, Rishi; Altman, Lisa; Koosis, Ella; Gelberg, Lillian

2017-01-01

Objectives: Homeless adults have low primary care engagement and high emergency department (ED) utilization. Homeless-tailored, patient-centered medical homes (PCMH) decrease this population’s acute care use. We studied the feasibility (focused on patient recruitment) and acceptability (conceptualized as clinicians’ attitudes/beliefs) of a pilot initiative to colocate a homeless-tailored PCMH with an ED. After ED triage, low-acuity patients appropriate for outpatient care were screened for homelessness; homeless patients chose between a colocated PCMH or ED visit. Methods: To study feasibility, we captured (from May to September 2012) the number of patients screened for homelessness, positive screens, unique patients seen, and primary care visits. We focused on acceptability to ED clinicians (physicians, nurses, social workers); we sent a 32-item survey to ED clinicians (n = 57) who worked during clinic hours. Questions derived from an instrument measuring clinician attitudes toward homeless persons; acceptability of homelessness screening and the clinic itself were also explored. Results: Over the 5 months of interest, 281 patients were screened; 172 (61.2%) screened positive for homelessness; 112 (65.1%) of these positive screens were seen over 215 visits. Acceptability data were obtained from 56% (n = 32) of surveyed clinicians. Attitudes toward homeless patients were similar to prior studies of primary care physicians. Most (54.6%) clinicians agreed with the homelessness screening procedures. Nearly all (90.3%) clinicians supported expansion of the homeless-tailored clinic; a minority (42.0%) agreed that ED colocation worked well. Conclusion: Our data suggest the feasibility of recruiting patients to a homeless-tailored primary care clinic colocated with the ED; however, the clinic’s acceptability was mixed. Future quality improvement work should focus on tailoring the clinic to increase its acceptability among ED clinicians, while assessing its impact on health, housing, and costs. PMID:28367682

Clinical psychologists' views of intensive interaction as an intervention in learning disability services.

PubMed

Berry, Ruth; Firth, Graham; Leeming, Catherine; Sharma, Vishal

2014-01-01

Intensive Interaction was initially developed in the 1980s as an educational approach for developing social communication and engagement with people with severe or profound intellectual disabilities and/or autism. Intensive Interaction has subsequently been adopted by a range of practitioners and professionals working in learning disability services and has a broad multi-disciplinary acceptance, being recommended in a number of UK governmental guidance documents. Despite this, there has been limited work on developing a deeper psychological understanding of the approach. This study utilises a qualitative description/thematic analysis approach to explore how clinical psychologists conceptualise the approach with regard to currently accepted psychological theories, as well as looking at other factors that influence their adoption and advocacy. The sample deliberately consisted of eight NHS (National Health Service) clinical psychologists known to be using or advocating the use of Intensive Interaction with people with a learning disability. The results of this study indicate that although the participants referred to some theories that might explain the beneficial outcomes of Intensive Interaction, these theories were rarely explicitly or clearly referenced, resulting in the authors having to attribute specific theoretical positions on the basis of inductive analysis of the participants' responses. Moreover, the participants provided varying views on how Intensive Interaction might be conceptualised, highlighting the lack of a generally accepted, psychologically framed definition of the approach. In conclusion, it was felt that further research is required to develop a specifically psychological understanding of Intensive Interaction alongside the formation of a Special Interest Group, which might have this task as one of its aims. There appeared to be a limited recognition amongst the participants of the specific psychological theories that can be seen to explain the beneficial outcomes of Intensive Interaction. The participants were found to differ in how they explained the approach and typically used everyday 'non-psychological' language or individual concepts/terms rather than clearly or extensively referencing particular theoretical models. The participants appeared to differ in the range of clients who they thought might benefit from Intensive Interaction. An Intensive Interaction Special Interest Group, which includes clinical psychologists, should be set up to instigate psychologically informed theory development and research with the broader aims of fostering greater understanding and adoption of Intensive Interaction within services for people with severe or profound intellectual disabilities and/or autism. Copyright © 2013 John Wiley & Sons, Ltd.

[Preliminary evaluation of plastic crown restoration supported by osseointegrated implants].

PubMed

Huang, J; Zhang, K

1997-08-01

This study was to evaluate the feasibility of plastic crown restoration supported by osseointegrated implants. The following conclusions were drawn from this study: plastic crown gave better biomechanical consideration than porcelain fused to metal (PFM) crown in osseointegrated prostheses, but plastic crown gave worse wearability, tensile strength, compression strength and flexuaral strength than PFM crown. After restoration the disadvantages of the plastic crown were beyond the clinical acceptable range. It showed plastic crown designed dental prothetic implantation was unfeasible.

Structured assessment of current mental state in clinical practice: an international study of the reliability and validity of the Current Psychiatric State interview, CPS-50.

PubMed

Falloon, I R H; Mizuno, M; Murakami, M; Roncone, R; Unoka, Z; Harangozo, J; Pullman, J; Gedye, R; Held, T; Hager, B; Erickson, D; Burnett, K

2005-01-01

To develop a reliable standardized assessment of psychiatric symptoms for use in clinical practice. A 50-item interview, the Current Psychiatric State 50 (CPS-50), was used to assess 237 patients with a range of psychiatric diagnoses. Ratings were made by interviewers after a 2-day training. Comparisons of inter-rater reliability on each item and on eight clinical subscales were made across four international centres and between psychiatrists and non-psychiatrists. A principal components analysis was used to validate these clinical scales. Acceptable inter-rater reliability (intra-class coefficient > 0.80) was found for 46 of the 50 items, and for all eight subscales. There was no difference between centres or between psychiatrists and non-psychiatrists. The principal components analysis factors were similar to the clinical scales. The CPS-50 is a reliable standardized assessment of current mental status that can be used in clinical practice by all mental health professionals after brief training. Blackwell Munksgaard 2004

Late post-operative recurrent osteosarcoma: Three case reports with a review of the literature

PubMed Central

YU, XIUCHUN; WU, SUJIA; WANG, XUQUAN; XU, MING; XU, SONGFENG; YUAN, YE

2013-01-01

The aim of the present study was to investigate the clinical characteristics and treatment of late recurrent osteosarcoma following surgery. The cases of three patients with late recurrent osteosarcoma, who were treated at the General Hospital of Jinan Military Command, General Hospital of Nanjing Military Command and Xinan Hospital of The Third Military Medical University, were analyzed retrospectively. Furthermore, 10 cases of late recurrent osteosarcoma were retrieved from the literature. In total, eight male and five female cases were selected for the present study. The mean age at recurrence was 25.56 years (range, 13–42 years). The locations of the osteosarcomas were as follows: five cases in the distal femur, two cases in the distal tibia and acetabulum, respectively, and one case in the proximal tibia (the remaining cases were not described). The tumors were histologically classified into three cases of fibroblastic, two cases of traditional-type; two cases of mixed-type and one case each of osteoblastic-, chondroblastic- and telangiectasia-type osteosarcoma (the remaining cases were not described). The mean recurrence time following surgery was 10.02 years (range, 5.2–19.3 years). With regard to the treatment modalities, five patients accepted surgery and chemotherapy, one patient accepted surgery and radiotherapy, two patients accepted surgery alone and one patient did not complete the treatment (the remaining cases were not described). From the 12 cases that were followed-up for between 0.5 and 4.7 years (mean, 2.28 years), one case was lost to follow-up, six patients survived (up to 4.5 years) and six patients succumbed to their condition (0.6–4.7 years). The present study highlights the fact that more focus should be placed upon the long-term follow-up of patients with osteosarcoma. A follow-up is required once every six months, from five years after the diagnosis. The abnormal changes in the surgical site should also receive further attention, in addition to the pulmonary and systemic metastases. Following a diagnosis of late post-operative recurrence, surgery and post-operative chemotherapy are commonly used in clinical treatment, however, the clinical outcome of osteosarcoma requires further observation. PMID:23946772

Diagnostic accuracy of clinical tests for assessment of hamstring injury: a systematic review.

PubMed

Reiman, Michael P; Loudon, Janice K; Goode, Adam P

2013-04-01

Systematic literature review. The diagnosis of a hamstring injury has traditionally relied on various clinical measures (eg, palpation, swelling, manual resistance), as well as the use of diagnostic imaging. But a few studies have suggested the use of specific clinical tests that may be helpful for the diagnostic process. To summarize the current literature on the diagnostic accuracy of orthopaedic special tests for hamstring injuries and to determine their clinical utility. A computer-assisted literature search of the MEDLINE, CINAHL, and Embase databases (along with a manual search of grey literature) was conducted using key words related to diagnostic accuracy of hamstring injuries. To be considered for inclusion in the review, the study required (1) patients with hamstring or posterior thigh pain; (2) a cohort, case-control, or cross-sectional design; (3) inclusion of at least 1 clinical examination test used to evaluate hamstring pathology; (4) comparison against an acceptable reference standard; (5) reporting of diagnostic accuracy of the measures (sensitivity [SN], specificity [SP], or likelihood ratios); and (6) publication in English. SN, SP, and positive and negative likelihood ratios were calculated for each diagnostic test. The search strategy identified 602 potential articles, of which only 3 articles met the inclusion criteria, with only 1 of these 3 articles being of high quality. Two of the studies investigated a single special test, whereas the third article examined a composite clinical assessment employing various special tests. The SN values ranged from 0.55 (95% confidence interval [CI]: 0.46, 0.69) for the active range-of-motion test to 1.00 (95% CI: 0.97, 1.00) for the taking-off-the-shoe test. The SP values ranged from 0.03 (95% CI: 0.00, 0.22) for the composite clinical assessment to 1.00 (95% CI: 0.97, 1.00) for the taking-off-the-shoe test, active range-of-motion test, passive range-of-motion test, and resisted range-of-motion test. The use of a single special test demonstrated stronger SP than SN properties, whereas the composite clinical assessment demonstrated stronger SN than SP properties. Very few studies have investigated the utilization of clinical special tests for the diagnosis of hamstring injuries. Further studies of higher quality design are suggested prior to advocating independent clinical utilization of these special tests. Diagnosis, level 3b.

CT colonography with reduced bowel preparation after incomplete colonoscopy in the elderly.

PubMed

Iafrate, F; Hassan, C; Zullo, A; Stagnitti, A; Ferrari, R; Spagnuolo, A; Laghi, A

2008-07-01

We prospectively assessed the feasibility and acceptance of computerized tomographic colonography (CTC) without bowel cathartic preparation in elderly patients after incomplete colonoscopy. A total of 136 patients underwent CTC without cathartic preparation. The time delay between conventional colonoscopy and CTC ranged between 3 and 20 days, depending on the clinical situation. Before CTC, fecal tagging was achieved by adding diatrizoate meglumine and diatrizoate sodium to regular meals. CTCs were interpreted using a primary two-dimensional (2D) approach and 3D images for further characterization. Patients were interviewed before and 2 weeks after CTC to assess preparation acceptance. CTC was feasible and technically successful in all the 136 patients. Fecal tagging was judged as excellent in 113 (83%) patients and sufficient in 23 (17%). Average CT image interpretation time was 14.8 min. Six (4.4%) cases of colorectal cancer and nine (6.6%) large polyps were detected, as well as 23 (11.3%) extracolonic findings of high clinical importance. No major side effect occurred, although 25% patients reported minor side effects, especially diarrhea. Overall, 76/98 patients replied that they would be willing to repeat the test if necessary. CTC without cathartic preparation is a technically feasible and safe procedure to complete a colonic study in the elderly, prompting its use in clinical practice.

Parent-child relationship disorders. Part I. Parental overprotection and the development of the Parent Protection Scale.

PubMed

Thomasgard, M; Metz, W P; Edelbrock, C; Shonkoff, J P

1995-08-01

There is a spectrum of parental protective behaviors promoting child safety and security, ranging from neglect to overprotection. This paper describes the development and psychometric properties of a new measure of parental protective behaviors toward children age 2 to 10 years, the Parent Protection Scale (PPS). Items were selected to represent key dimensions of protective behaviors. Factor analyses suggested four subscales: Supervision, Separation Problems, Dependence, and Control. The PPS has acceptable internal consistency, test-retest reliability, and clinical validity. Norms by child age in the form of cutoff points corresponding to +1 SD were determined. Clinical and research uses for the PPS are noted.

Trauma-related emotions and radical acceptance in dialectical behavior therapy for posttraumatic stress disorder after childhood sexual abuse.

PubMed

Görg, Nora; Priebe, Kathlen; Böhnke, Jan R; Steil, Regina; Dyer, Anne S; Kleindienst, Nikolaus

2017-01-01

Posttraumatic Stress Disorder (PTSD) related to childhood sexual abuse (CSA) is often associated with a wide range of trauma-related aversive emotions such as fear, disgust, sadness, shame, guilt, and anger. Intense experience of aversive emotions in particular has been linked to higher psychopathology in trauma survivors. Most established psychosocial treatments aim to reduce avoidance of trauma-related memories and associated emotions. Interventions based on Dialectical Behavior Therapy (DBT) also foster radical acceptance of the traumatic event. This study compares individual ratings of trauma-related emotions and radical acceptance between the start and the end of DBT for PTSD (DBT-PTSD) related to CSA. We expected a decrease in trauma-related emotions and an increase in acceptance. In addition, we tested whether therapy response according to the Clinician Administered PTSD-Scale (CAPS) for the DSM-IV was associated with changes in trauma-related emotions and acceptance. The data was collected within a randomized controlled trial testing the efficacy of DBT-PTSD, and a subsample of 23 women was included in this secondary data analysis. In a multilevel model, shame, guilt, disgust, distress, and fear decreased significantly from the start to the end of the therapy whereas radical acceptance increased. Therapy response measured with the CAPS was associated with change in trauma-related emotions. Trauma-related emotions and radical acceptance showed significant changes from the start to the end of DBT-PTSD. Future studies with larger sample sizes and control group designs are needed to test whether these changes are due to the treatment. ClinicalTrials.gov, number NCT00481000.

First of all: Do not harm! Use of simulation for the training of regional anaesthesia techniques: Which skills can be trained without the patient as substitute for a mannequin.

PubMed

Sujatta, Susanne

2015-03-01

Character of clinical skills training is always influenced by technical improvement and cultural changes. Over the last years, two trends have changed the way of traditional apprenticeship-style training in regional anaesthesia: firstly, the development in ultrasound-guided regional anaesthesia, and secondly, the reduced acceptance of using patients as mannequins for invasive techniques. Against this background, simulation techniques are explored, ranging from simple low-fidelity part-task training models to train skills in needle application, to highly sophisticated virtual reality models – the full range is covered. This review tries to discuss all available options with benefits and neglects. The task in clinical practice will be in choosing the right level of sophistication for the desired approach and trainee level. However, the transfer of simulated skills to clinical practice has not been evaluated. It has to be proven whether simulation-trained skills could, as a last consequence, reduce the risk to patients. Copyright © 2015 Elsevier Ltd. All rights reserved.

Screening for Spiritual Struggle in an Adolescent Transgender Clinic: Feasibility and Acceptability.

PubMed

Grossoehme, Daniel H; Teeters, Alexis; Jelinek, Sue; Dimitriou, Sophia M; Conard, Lee Ann E

2016-01-01

Spiritual struggles are associated with poorer health outcomes, including depression, which has higher prevalence among transgender individuals than the general population. This study's objective was to improve the quality of care in an outpatient transgender clinic by screening patients and caregivers for spiritual struggle and future intervention. The quality improvement questions addressed were whether screening for spiritual struggle was feasible and acceptable; and whether the sensitivity and specificity of the Rush Protocol were acceptable. Revision of the screening was based on cognitive interviews with the 115 adolescents and caregivers who were screened. Prevalence of spiritual struggle was 38-47%. Compared to the Negative R-COPE, the Rush Protocol screener had sensitivities of 44-80% and specificities of 60-74%. The Rush Protocol was acceptable to adolescents seen in a transgender clinic, caregivers, and clinic staff; was feasible to deliver during outpatient clinic visits, and offers a straightforward means of identifying transgender persons and caregivers experiencing spiritual struggle.

Acceptance and attitudes of healthcare staff towards the introduction of clinical pharmacy service: a descriptive cross-sectional study from a tertiary care hospital in Sri Lanka.

PubMed

Shanika, Lelwala Guruge Thushani; Wijekoon, Chandrani Nirmala; Jayamanne, Shaluka; Coombes, Judith; Coombes, Ian; Mamunuwa, Nilani; Dawson, Andrew Hamilton; De Silva, Hithanadura Asita

2017-01-18

Multidisciplinary patient management including a clinical pharmacist shows an improvement in patient quality use of medicine. Implementation of a clinical pharmacy service represents a significant novel change in practice in Sri Lanka. Although attitudes of doctors and nurses are an important determinant of successful implementation, there is no Sri Lankan data about staff attitudes to such changes in clinical practice. This study determines the level of acceptance and attitudes of doctors and nurses towards the introduction of a ward-based clinical pharmacy service in Sri Lanka. This is a descriptive cross-sectional sub-study which determines the acceptance and attitudes of healthcare staff about the introduction of a clinical pharmacy service to a tertiary care hospital in Sri Lanka. The level of acceptance of pharmacist's recommendations regarding drug-related problems (DRPs) was measured. Data regarding attitudes were collected through a pre-tested self-administered questionnaires distributed to doctors (baseline, N =13, post-intervention period, N = 12) and nurses (12) worked in professorial medical unit at baseline and post-intervention period. A total of 274 (272 to doctors and 2 to nurses) recommendations regarding DRPs were made. Eighty three percent (225/272) and 100% (2/2) of the recommendations were accepted by doctors and nurses, respectively. The rate of implementation of pharmacist's recommendations by doctors was 73.5% (200/272) (95% CI 67.9 - 78.7%; P < 0.001). The response rate of doctors was higher at the post-intervention period (92.3%; 12/13) compared to the baseline (66.7%; 8/12). At the post-intervention survey 91.6% of doctors were happy to work with competent clinical pharmacists and accepted the necessity of this service to improve standards of care. The nurses' rate of response at baseline and post-intervention surveys were 80.0 and 0.0% respectively. Their perceptions on the role of clinical pharmacist were negative at baseline survey. There was high acceptance and implementation of clinical pharmacist's recommendations regarding DRPs by the healthcare team. The doctors' views and attitudes were positive regarding the inclusion of a ward-based pharmacist to the healthcare team. However there is a need to improve liaison between clinical pharmacist and nursing staff. Sri Lanka Clinical Trials Registry SLCTR/2013/029 Date: 13 September 2013; retrospectively registered.

Postgraduate Clinical Psychology Students' Perceptions of an Acceptance and Commitment Therapy Stress Management Intervention and Clinical Training

ERIC Educational Resources Information Center

Pakenham, Kenneth I.; Stafford-Brown, Johanna

2013-01-01

Background: Research into stress management interventions for clinical psychology trainees (CPTs) is limited, despite evidence indicating that these individuals are at risk for elevated stress, which can negatively impact personal and professional functioning. This study explored: (1) CPTs' perceptions of a previously evaluated Acceptance and…

First clinical evaluation of a new long-term subconjunctival glucose sensor.

PubMed

Müller, Achim Josef; Knuth, Monika; Nikolaus, Katharina Sibylle; Herbrechtsmeier, Peter

2012-07-01

To evaluate the feasibility of an implantable subconjunctival glucose monitoring system (SGMS) for glucose monitoring in humans, we investigated the in vivo performance of the sensor in a clinical trial with five patients. The new SGMS consists of an implantable ocular mini implant (OMI) and a hand-held fluorescence photometer. The implantable subconjunctival glucose sensor is composed of a fluorescence resonance energy transfer system based on Concanavalin A chemistry, embedded in a nelfilcon polymer hydrogel disk. Blood glucose changes in humans were induced by oral glucose intake and insulin injections. The in vivo response of the new SGMS was tested in a first human clinical study with five diabetes patients. The OMI was well tolerated in the eyes of the patients. The SGMS exhibited high correlation coefficients (>0.88) with blood glucose changes and a good stability of the sensor response to glucose for the study period of 2 weeks. Lag times were in the range of 5-10 min. A total of 98% of all data pairs was in the clinical acceptable ranges A and B of the consensus error grid. For the first time, the possibility to measure glucose in vivo in the subconjunctival interstitial fluid for a period of 2 weeks was demonstrated in a human clinical trial. © 2012 Diabetes Technology Society.

Acceptance, commissioning and clinical use of the WOmed T-200 kilovoltage X-ray therapy unit

PubMed Central

Zucchetti, Paolo

2015-01-01

Objective: The objective of this work was to characterize the performance of the WOmed T-200-kilovoltage (kV) therapy machine. Methods: Mechanical functionality, radiation leakage, alignment and interlocks were investigated. Half-value layers (HVLs) (first and second HVLs) from X-ray beams generated from tube potentials between 30 and 200 kV were measured. Reference dose was determined in water. Beam start-up characteristics, dose linearity and reproducibility, beam flatness, and uniformity as well as deviations from inverse square law were assessed. Relative depth doses (RDDs) were determined in water and water-equivalent plastic. The quality assurance program included a dosimetry audit with thermoluminescent dosemeters. Results: All checks on machine performance were satisfactory. HVLs ranged between 0.45–4.52 mmAl and 0.69–1.78 mmCu. Dose rates varied between 0.2 and 3 Gy min−1 with negligible time-end errors. There were differences in measured RDDs from published data. Beam outputs were confirmed with the dosimetry audit. The use of published backscatter factors was implemented to account for changes in phantom scatter for treatments with irregularly shaped fields. Conclusion: Guidance on the determination of HVL and RDD in kV beams can be contradictory. RDDs were determined through measurement and curve fitting. These differed from published RDD data, and the differences observed were larger in the low-kV energy range. Advances in knowledge: This article reports on the comprehensive and novel approach to the acceptance, commissioning and clinical use of a modern kV therapy machine. The challenges in the dosimetry of kV beams faced by the medical physicist in the clinic are highlighted. PMID:26224430

Towards Achieving the Full Clinical Potential of Proton Therapy by Inclusion of LET and RBE Models

PubMed Central

Jones, Bleddyn

2015-01-01

Despite increasing use of proton therapy (PBT), several systematic literature reviews show limited gains in clinical outcomes, with publications mostly devoted to recent technical developments. The lack of randomised control studies has also hampered progress in the acceptance of PBT by many oncologists and policy makers. There remain two important uncertainties associated with PBT, namely: (1) accuracy and reproducibility of Bragg peak position (BPP); and (2) imprecise knowledge of the relative biological effect (RBE) for different tissues and tumours, and at different doses. Incorrect BPP will change dose, linear energy transfer (LET) and RBE, with risks of reduced tumour control and enhanced toxicity. These interrelationships are discussed qualitatively with respect to the ICRU target volume definitions. The internationally accepted proton RBE of 1.1 was based on assays and dose ranges unlikely to reveal the complete range of RBE in the human body. RBE values are not known for human (or animal) brain, spine, kidney, liver, intestine, etc. A simple efficiency model for estimating proton RBE values is described, based on data of Belli et al. and other authors, which allows linear increases in α and β with LET, with a gradient estimated using a saturation model from the low LET α and β radiosensitivity parameter input values, and decreasing RBE with increasing dose. To improve outcomes, 3-D dose-LET-RBE and bio-effectiveness maps are required. Validation experiments are indicated in relevant tissues. Randomised clinical studies that test the invariant 1.1 RBE allocation against higher values in late reacting tissues, and lower tumour RBE values in the case of radiosensitive tumours, are also indicated. PMID:25790470

Internet-based Mindfulness Meditation for Cognition and Mood in Older Adults: A Pilot Study.

PubMed

Wahbeh, Helané; Goodrich, Elena; Oken, Barry S

2016-01-01

Older adults are at risk for greater chronic stress and cognitive decline. Training in mindfulness meditation (MM) may help reduce stress and, thus, cognitive decline in older adults, but little research has explored that hypothesis. The current study's primary aim was to evaluate the feasibility and acceptability for use by older adults of the Internet Mindfulness Meditation Intervention (IMMI), a program that had been developed by the research team, as well as of an Internet-based health-and-wellness education program, the control. The secondary aim was to collect preliminary pre- and postintervention data on mood and cognitive function. The study was a randomized, controlled trial (RCT), a pilot study, with participants randomized either to the meditation group or the education group. Participants obtained access to the programs from their homes, and the baseline and endpoint assessments occurred in their homes as well. Older adults aged 65-90 y were recruited from the Portland, OR, metropolitan area. Twenty-one people enrolled in the study. Participants in both groups took part in a 1-h online session each week for 6 wk, with 30 min of daily home practice. Feasibility and acceptability were assessed through measures of adherence to the protocol and a client satisfaction questionnaire. Mood and cognitive outcomes were also evaluated before and after the interventions. Sixteen participants completed the study, 8 in each group, and 5 dropped out, for a 76% completion rate. Participants' mean age was 76.2 y; 88% were Caucasian, and 50% were female. Acceptability was high for the interventions, based on above-average scores on the client satisfaction questionnaire. The IMMI participants completed (1) 4.25 ± 2.4 sessions, with a range of 0-6; (2) 604 ± 506 home-practice minutes, with a range 0-1432; and (3) 21.3 ± 15.5 d of practice, with a range of 0-46. The education group completed (1) 4.75 ± 1.8 sessions, with a range of 2-6; (2) 873 ± 395 home-practice minutes, with a range of 327-1524; and (3) 25.6 d of practice, with a range of 11-35. The intervention and control formats were both feasible, and the control group was appropriate. As expected due to the pilot nature of the study, no differences existed between groups for the mood or cognitive outcomes. Administering interventions via the Internet to older adults is feasible. The 2 interventions were acceptable to participants and equal with regard to perceived credibility and acceptability. Future RCTs are planned to evaluate the clinical efficacy of the 2 interventions.

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.

[Willingness on accepting the short-message-service and factors related to HIV/STD testing among male STD clinic clients].

PubMed

Meng, Xiaojun; Zou, Huachun; Jia, Tianjian; Zhu, Chen; Chen, Xin; Zhang, Xuan

2015-12-01

To understand the willingness on acceptance of a short-messageservice (SMS) program provided for HIV/STD testing and the related factors, among male clients at the STD clinics in China. Convenience sampling method was used to select study subjects at a STD clinic in Wuxi, Jiangsu province. A questionnaire survey was conducted among the subjects to collect the information on socio-demographic characteristics and willingness of acceptance to the SMS. A total of 368 SMS subjects were surveyed, in which 75.5% expressed the willingness of acceptance, while 57.2% and 38.1% of them wanted to receive the short message every 3 months or 6 months, respectively. 53.8% of the respondents showed their willingness to share the news with their sexual partners about SMS and 44.8% of them would do the same to their friends. Data from the Multivariate logistic regression analysis showed that those who had received senior high school or above education (aOR=3.632, 95%CI: 1.939-6.715) , having homosexual behavior (aOR = 1.973, 95%CI: 1.234-8.358) or those having received AIDS related intervention service in the past year (aOR=9.416, 95%CI: 4.822-18.309) were more likely to accept the SMS. SMS seemed to be acceptable among the male STD clinic clients in Wuxi, suggesting that it is feasible to conduct the SMS as a strategy to improve the HIV/STDs testing program at the STD clinics in the future. Promotion of SMS should be strengthened and the provision of general AIDS intervention service at the STD clinics should be established in order to make more STD clinic clients understand this SMS.

Evaluation of the Hitachi 717 analyser.

PubMed

Biosca, C; Antoja, F; Sierra, C; Douezi, H; Macià, M; Alsina, M J; Galimany, R

1989-01-01

The selective multitest Boehringer Mannheim Hitachi 717 analyser was evaluated according to the guidelines of the Comisión de Instrumentación de la Sociedad Española de Química Clinica and the European Committee for Clinical Laboratory Standards. The evaluation was performed in two steps: examination of the analytical units and evaluation in routine operation.THE EVALUATION OF THE ANALYTICAL UNITS INCLUDED A PHOTOMETRIC STUDY: the inaccuracy is acceptable for 340 and 405 nm; the imprecision ranges from 0.12 to 0.95% at 340 nm and from 0.30 to 0.73 at 405 nm, the linearity shows some dispersion at low absorbance for NADH at 340 nm, the drift is negligible, the imprecision of the pipette delivery system increases when the sample pipette operates with 3 mul, the reagent pipette imprecision is acceptable and the temperature control system is good.UNDER ROUTINE WORKING CONDITIONS, SEVEN DETERMINATIONS WERE STUDIED: glucose, creatinine, iron, total protein, AST, ALP and calcium. The within-run imprecision (CV) ranged from 0.6% for total protein and AST to 6.9% for iron. The between run imprecision ranged from 2.4% for glucose to 9.7% for iron. Some contamination was found in the carry-over study. The relative inaccuracy is good for all the constituents assayed.

[Comparability study of analytical results between a group of clinical laboratories].

PubMed

Alsius-Serra, A; Ballbé-Anglada, M; López-Yeste, M L; Buxeda-Figuerola, M; Guillén-Campuzano, E; Juan-Pereira, L; Colomé-Mallolas, C; Caballé-Martín, I

2015-01-01

To describe the study of the comparability of the measurements levels of biological tests processed in biochemistry in Catlab's 4 laboratories. Quality requirements, coefficients of variation and total error (CV% and TE %) were established. Controls were verified with the precision requirements (CV%) in each test and each individual laboratory analyser. Fresh serum samples were used for the comparability study. The differences were analysed using a Microsoft Access® application that produces modified Bland-Altman plots. The comparison of 32 biological parameters that are performed in more than one laboratory and/or analyser generated 306 Bland-Altman graphs. Of these, 101 (33.1%) fell within the accepted range of values based on biological variability, and 205 (66.9%) required revision. Data were re-analysed based on consensus minimum specifications for analytical quality (consensus of the Asociación Española de Farmacéuticos Analistas (AEFA), the Sociedad Española de Bioquímica Clínica y Patología Molecular (SEQC), the Asociación Española de Biopatología Médica (AEBM) and the Sociedad Española de Hematología y Hemoterapia (SEHH), October 2013). With the new specifications, 170 comparisons (56%) fitted the requirements and 136 (44%) required additional review. Taking into account the number of points that exceeded the requirement, random errors, range of results in which discrepancies were detected, and range of clinical decision, it was shown that the 44% that required review were acceptable, and the 32 tests were comparable in all laboratories and analysers. The analysis of the results showed that the consensus requirements of the 4 scientific societies were met. However, each laboratory should aim to meet stricter criteria for total error. Copyright © 2015 SECA. Published by Elsevier Espana. All rights reserved.

Acceptable range of speech level in noisy sound fields for young adults and elderly persons.

PubMed

Sato, Hayato; Morimoto, Masayuki; Ota, Ryo

2011-09-01

The acceptable range of speech level as a function of background noise level was investigated on the basis of word intelligibility scores and listening difficulty ratings. In the present study, the acceptable range is defined as the range that maximizes word intelligibility scores and simultaneously does not cause a significant increase in listening difficulty ratings from the minimum ratings. Listening tests with young adult and elderly listeners demonstrated the following. (1) The acceptable range of speech level for elderly listeners overlapped that for young listeners. (2) The lower limit of the acceptable speech level for both young and elderly listeners was 65 dB (A-weighted) for noise levels of 40 and 45 dB (A-weighted), a level with a speech-to-noise ratio of +15 dB for noise levels of 50 and 55 dB, and a level with a speech-to-noise ratio of +10 dB for noise levels from 60 to 70 dB. (3) The upper limit of the acceptable speech level for both young and elderly listeners was 80 dB for noise levels from 40 to 55 dB and 85 dB or above for noise levels from 55 to 70 dB. © 2011 Acoustical Society of America

Test-retest reliability of 3D ultrasound measurements of the thoracic spine.

PubMed

Fölsch, Christian; Schlögel, Stefanie; Lakemeier, Stefan; Wolf, Udo; Timmesfeld, Nina; Skwara, Adrian

2012-05-01

To explore the reliability of the Zebris CMS 20 ultrasound analysis system with pointer application for measuring end-range flexion, end-range extension, and neutral kyphosis angle of the thoracic spine. The study was performed within the School of Physiotherapy in cooperation with the Orthopedic Department at a University Hospital. The thoracic spines of 28 healthy subjects were measured. Measurements for neutral kyphosis angle, end-range flexion, and end-range extension were taken once at each time point. The bone landmarks were palpated by one examiner and marked with a pointer containing 2 transmitters using a frequency of 40 kHz. A third transmitter was fixed to the pelvis, and 3 microphones were used as receiver. The real angle was calculated by the software. Bland-Altman plots with 95% limits of agreement, intraclass correlations (ICC), standard deviations of mean measurements, and standard error of measurements were used for statistical analyses. The test-retest reliability in this study was measured within a 24-hour interval. Statistical parameters were used to judge reliability. The mean kyphosis angle was 44.8° with a standard deviation of 17.3° at the first measurement and a mean of 45.8° with a standard deviation of 16.2° the following day. The ICC was high at 0.95 for the neutral kyphosis angle, and the Bland-Altman 95% limits of agreement were within clinical acceptable margins. The ICC was 0.71 for end-range flexion and 0.34 for end-range extension, whereas the Bland-Altman 95% limits of agreement were wider than with the static measurement of kyphosis. Compared with static measurements, the analysis of motion with 3-dimensional ultrasound showed an increased standard deviation for test-retest measurements. The test-retest reliability of ultrasound measuring of the neutral kyphosis angle of the thoracic spine was demonstrated within 24 hours. Bland-Altman 95% limits of agreement and the standard deviation of differences did not appear to be clinically acceptable for measuring flexion and extension. Copyright © 2012 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Perceptions of the acceptability of parent training among Chinese immigrant parents: contributions of cultural factors and clinical need.

PubMed

Ho, Judy; Yeh, May; McCabe, Kristen; Lau, Anna

2012-06-01

Parent training (PT) is well established for reducing child externalizing problems; however, lower rates of engagement in PT among ethnic minority/immigrant families have been found. We assessed PT acceptability among Chinese immigrant parents and explored clinical and cultural factors that may be associated with acceptability. Participants were a community sample of 145 Chinese immigrant parents (84% mothers) between the ages of 32 and 65 years (M=43.3 years, SD=6.2) who had children (84 boys, 59 girls) between the ages of 4 and 17 years (M=10.7 years, SD=3.6). Results suggest that parents found positive reinforcement techniques significantly more acceptable, less problematic, and more likely to be supported by others than punishment-based techniques. Parents who endorsed the Chinese child-rearing value of shaming were less likely to find PT acceptable. Parents who reported greater dysfunction in parent-child interactions rated PT as more acceptable, and families with prior Child Protective Services (CPS) involvement rated PT as less acceptable. However, previous mental health treatment appears to bolster acceptability among parents with prior CPS involvement. Clinical implications for addressing barriers to PT engagement and future research directions are discussed. Copyright © 2011. Published by Elsevier Ltd.

Effect of denture cleansers on color stability, surface roughness, and hardness of different denture base resins

PubMed Central

Porwal, Anand; Khandelwal, Meenakshi; Punia, Vikas; Sharma, Vivek

2017-01-01

Aim: The purpose of this study was to evaluate the effect of different denture cleansers on the color stability, surface hardness, and roughness of different denture base resins. Materials and Methods: Three denture base resin materials (conventional heat cure resin, high impact resin, and polyamide denture base resin) were immersed for 180 days in commercially available two denture cleansers (sodium perborate and sodium hypochlorite). Color, surface roughness, and hardness were measured for each sample before and after immersion procedure. Statistical Analysis: One-way analysis of variance and Tukey's post hoc honestly significant difference test were used to evaluate color, surface roughness, and hardness data before and after immersion in denture cleanser (α =0.05). Results: All denture base resins tested exhibited a change in color, surface roughness, and hardness to some degree in both denture cleansers. Polyamides resin immersed in sodium perborate showed a maximum change in color after immersion for 180 days. Conventional heat cure resin immersed in sodium hypochlorite showed a maximum change in surface roughness and conventional heat cure immersed in sodium perborate showed a maximum change in hardness. Conclusion: Color changes of all denture base resins were within the clinically accepted range for color difference. Surface roughness change of conventional heat cure resin was not within the clinically accepted range of surface roughness. The choice of denture cleanser for different denture base resins should be based on the chemistry of resin and cleanser, denture cleanser concentration, and duration of immersion. PMID:28216847

Clinical Trial Results Summary for Laypersons: A User Testing Study.

PubMed

Raynor, D K; Myers, L; Blackwell, K; Kress, B; Dubost, A; Joos, A

2018-01-01

To apply "user testing" to maximize readability and acceptability of a Clinical Trial Results Laypersons Summary-a new European requirement. "User testing" (using questionnaire and semistructured interview) assessed whether people could find and understand key points. Findings were used to improve content and design, prior to retesting. Participants had a range of levels of health literacy and there was a higher education group. Participants accessed the summary on screen. In round 1 we tested 12 points of information. In round 2 a revised summary addressing round 1 findings was tested, leading to a third final version. In round 1, 2 of 12 points of information did not reach the target and interviews raised further format and content issues (some distracting technical explanations and inability to find or understand the 2 main study purposes). These findings informed revisions for the version tested in round 2, with 2 different points not reaching the target (inclusion criteria relating to duration of seasonal allergies and how researchers found out about participants' symptoms). Identified problems in both rounds were addressed and reflected in the final version. Despite improvements, participants did not consistently understand that summaries were intended for the public, or to only interpret results of single trials in the context of additional trials. All readers, including those with higher education, found the clear and straightforward language acceptable. Applying "user testing" resulted in a largely health-literate summary suitable for people across a range of backgrounds.

Sensitivity and Specificity of 2 Autism Screeners Among Referred Children Between 16 and 48 Months of Age.

PubMed

Salisbury, Louisa A; Nyce, Jonathan D; Hannum, Charles D; Sheldrick, R Christopher; Perrin, Ellen C

2018-04-01

Autism screening is recommended by the American Academy of Pediatrics and the Centers for Disease Control and Prevention at ages 18 and 24 months. Popular screening tests have been validated for the age range of 16 to 30 months. However, only a minority of children with autism spectrum disorder (ASD) are identified by age 3 years, and many are not identified until after they enter school. Thus, we aimed to measure the sensitivity and specificity of 2 available screening tests for ASDs in children older than 30 months. We assessed the sensitivity and specificity of 2 ASD screening tools administered to parents of children who were referred to a developmental clinic between the ages of 16 and 48 months: the Modified Checklist for Autism in Toddlers (M-CHAT) and the Parent's Observations of Social Interactions (POSI), which is a component of a comprehensive screening instrument called, the Survey of Well-being of Young Children. Both the M-CHAT and the POSI had acceptable sensitivity (≥75%) among children across the age range studied. Their specificity was limited by the fact that the study was conducted in a developmental referral clinic. Two readily available screening tools, the POSI and the M-CHAT, have acceptable sensitivity in evaluating risk for autism in children at least to age 48 months. Further research should investigate their sensitivity and specificity when used in primary care settings.

Learning PDA skills online is feasible and acceptable to clerkship students.

PubMed

Strayer, Scott M; Williams, Pamela M; Stephens, Mark B; Yew, Kenneth S

2008-01-01

The feasibility and acceptability of teaching medical students to use PDA clinical decision support tools via a Web-based course have not been previously evaluated. A total of 119 third-year family medicine clerkship students completed a baseline survey on PDA use, attended an introductory PDA lecture, and were invited to voluntarily access a Web-based course through Blackboard. All students had been previously issued with PDAs in their second year. At baseline, 95% of students reported having removed their PDA from its box, 59% reported using it weekly, and 71% had loaded medical applications. From August 2006--March 2007, 36 students accessed the course 610 times (range 8-54). The PDA cases comprised 63% of hits, course resources 30% of hits, and course information 6% of hits. Students evaluated the course equally to other clerkship didactics. It is feasible and acceptable to students to teach PDA decision support tools in an online course. In our setting, for the minority of students who chose to learn online, the format was successful and met their needs.

A Critical Review of the Quality of Cough Clinical Practice Guidelines.

PubMed

Jiang, Mei; Guan, Wei-Jie; Fang, Zhang-Fu; Xie, Yan-Qing; Xie, Jia-Xing; Chen, Hao; Wei, Dang; Lai, Ke-Fang; Zhong, Nan-Shan

2016-10-01

Clinical practice guidelines (CPGs) have been developed to provide health-care practitioners with the best possible evidence, but the quality of these CPGs varies greatly. The goal of this study was to systematically evaluate the quality of cough CPGs and identify gaps limiting evidence-based practice. Systematic searches were conducted to identify cough CPGs in guideline databases, developers' Websites, and Medline. Four reviewers independently evaluated eligible guidelines by using the Appraisal of Guidelines for Research and Evaluation II assessment tool. Agreement among reviewers was measured by using the intraclass correlation coefficient. The number of recommendations, strength of recommendation, and levels of evidence were determined. Fifteen cough CPGs were identified. An overall high degree of agreement among reviewers was observed (intraclass correlation coefficient, 0.82 [95% CI, 0.79-0.85]). The quality ranged from good to acceptable in the scope and purpose (mean, 72%; range, 54%-93%) and clarity and presentation (mean, 68%; range, 50%-90%) domains but not in stakeholder involvement (mean, 36%; range, 18%-90%), rigor of development (mean, 36%; range, 9%-93%), applicability (mean, 23%; range, 9%-83%), and editorial independence domains (mean, 24%; range, 0-96%). Seven guidelines (46.7%) were considered "strongly recommended" or "recommended with modifications" for clinical practice. More than 70% of recommendations were based on nonrandomized studies (Level C, 30.4%) and expert opinion (Level D, 41.3%). The quality of cough CPGs is variable, and recommendations are largely based on low-quality evidence. There is significant room for improvement to develop high-quality guidelines, which urgently warrants first-class research to minimize the vital gaps in the evidence for formulation of cough CPGs. Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

Communication techniques for improved acceptance and adherence with therapeutic footwear.

PubMed

van Netten, Jaap J; Francis, Anthony; Morphet, Ashley; Fortington, Lauren V; Postema, Klaas; Williams, Anita

2017-04-01

Clients' acceptance and adherence with orthoses can be influenced by a clinician's communication skills. In this clinical note, we describe two communication techniques, in the context of therapeutic footwear. Person-centred communication involves engaging with and listening to the attitudes of the client towards their condition, as well as discussing acceptance and expectations, in a structured consultation. Building a relationship is crucial and requires clients to feel heard and understood. An important influence on the acceptance and adherence is that a client makes a conscious decision to receive their device. This active receipt can be facilitated through shared decision making, wherein clinicians give clear, relevant and meaningful examples, based on clinical evidence, and ensure this is understood. Two communication techniques for clinicians providing therapeutic footwear are described. These can be adapted for use with provision of other assistive technologies to improve client acceptance and adherence. Clinical relevance Small changes in how clinicians communicate to their clients in daily practice can have a big influence on the subsequent acceptance and adherence with therapeutic footwear and indeed other prescribed assistive technologies.

Impact of antimicrobial stewardship programme on hospitalized patients at the intensive care unit: a prospective audit and feedback study.

PubMed

Khdour, Maher R; Hallak, Hussein O; Aldeyab, Mamoon A; Nasif, Mowaffaq A; Khalili, Aliaa M; Dallashi, Ahamad A; Khofash, Mohammad B; Scott, Michael G

2018-04-01

Inappropriate use of antibiotics is one of the most important factors contributing to the emergence of drug resistant pathogens. The purpose of this study was to measure the clinical impact of antimicrobial stewardship programme (ASP) interventions on hospitalized patients at the Intensive care unit at Palestinian Medical Complex. A prospective audit with intervention and feedback by ASP team within 48-72 h of antibiotic administration began in September 2015. Four months of pre-ASP data were compared with 4 months of post-ASP data. Data collected included clinical and demographic data; use of antimicrobials measured by defined daily doses, duration of therapy, length of stay, readmission and all-cause mortality. Overall, 176 interventions were made the ASP team with an average acceptance rate of 78.4%. The most accepted interventions were dose optimization (87.0%) followed by de-escalation based on culture results with an acceptance rate of 84.4%. ASP interventions significantly reduces antimicrobial use by 24.3% (87.3 defined daily doses/100 beds vs. 66.1 defined daily doses/100 beds P < 0.001). The median (interquartile range) of length of stay was significantly reduced post ASP [11 (3-21) vs. 7 (4-19) days; P < 0.01]. Also, the median (interquartile range) of duration of therapy was significantly reduced post-ASP [8 (5-12) days vs. 5 (3-9); P = 0.01]. There was no significant difference in overall 30-day mortality or readmission between the pre-ASP and post-ASP groups (26.9% vs. 23.9%; P = 0.1) and (26.1% vs. 24.6%; P = 0.54) respectively. Our prospective audit and feedback programme was associated with positive impact on antimicrobial use, duration of therapy and length of stay. © 2017 The British Pharmacological Society.

Clinical performance of bonded ceramic inlays/onlays: A 5- to 18-year retrospective longitudinal study.

PubMed

Borgia Botto, Ernesto; Baró, Rosario; Borgia Botto, José Luis

2016-08-01

This retrospective longitudinal study evaluated the clinical performance of bonded ceramic inlays/onlays, placed by the first author in his private practice, in a 5 to 18-year period. The patients evaluated had been treated in the office for at least 7 years and were still in the practice up to year 2013. 130 randomly selected patients agreed to participate in the study. 93 bonded ceramic inlays/onlays (BCRs), were placed on posterior teeth in 47 subjects. Gender, age, tooth preparation, number, type, extent, location, quality and survival of the restorations, ceramic materials, luting resins cements, parafunctional habits, secondary caries and maintenance therapy were the variables evaluated. Cohen 's Kappa coefficient, on the quality analysis of the restorations, ranged from 0.78 to 1. Fisher 's exact test, Chi Square test, Kruskal-Wallis test and Mann-Whitney non-parametric test were indicated to analyze significant differences. At the initial examination, 87 (93.5%) restorations were in function and six failed (6.5%). 81 (93%) were rated as clinical successes. The observed mean survival time of those that remained functional was 11 years. The standard deviation was 4 years, with a 95% CI for the overall observed mean survival time (10 years-11 years, 9 months). 87 of 93 BCRs had a functional success of 93.5%, with an observed mean survival of 11 years. The clinical performance of bonded ceramic onlays was very acceptable. Bonded ceramic onlays showed a predictable, esthetic, and functional treatment, with acceptable longevity.

Awareness and attitudes of the Lebanese population with regard to physician-pharmaceutical company interaction: a survey study.

PubMed

Ammous, Ahmad; Bou Zein Eddine, Savo; Dani, Alia; Dbaibou, Jana; El-Asmar, Jose M; Sadder, Liane; Akl, Elie A

2017-03-31

To assess the awareness and attitudes of the general public in Lebanon regarding the interactions between physicians and pharmaceutical companies. Primary healthcare clinics and shopping malls in the Greater Beirut Area. 263 participants completed the questionnaire, of whom 62% were female and 38% were male. Eligible participants were Arabic-speaking or English-speaking adults (age≥18 years) residing in Lebanon for at least 5 years. Awareness, attitudes and beliefs of the general public. 263 out of 295 invited individuals (89% completion rate) completed the questionnaire. While the majority of participants were aware of pharmaceutical company presence (or absence) in physicians' offices (range of 71-76% across questions), smaller percentages were aware of gift-related practices of physicians (range of 26-69% across questions). 40% thought that the acceptance of small gifts or meals by physicians is wrong/unethical. The percentage of participants reporting lower trust in physicians due to their participation in various pharmaceutical company-related activities ranged from 12% to 45% (the highest percentage being for large gifts). Participants who reported receiving free medication samples were significantly more likely to consider physicians' acceptance of small gifts as 'not a problem' than 'unethical' (OR=1.53; p=0.044). Participants in our survey were generally more aware of pharmaceutical company presence (or absence) in physicians' offices than of gift-related practices of physicians. While the level of trust was not affected for the majority of participants for various types of interactions, it was affected the most for accepting large gifts. 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/.

A theory-based decision aid for patients with cancer: results of feasibility and acceptability testing of DecisionKEYS for cancer.

PubMed

Hollen, Patricia J; Gralla, Richard J; Jones, Randy A; Thomas, Christopher Y; Brenin, David R; Weiss, Geoffrey R; Schroen, Anneke T; Petroni, Gina R

2013-03-01

Appropriate utilization of treatment is a goal for all patients undergoing cancer treatment. Proper treatment maximizes benefit and limits exposure to unnecessary measures. This report describes findings of the feasibility and acceptability of implementing a short, clinic-based decision aid and presents an in-depth clinical profile of the participants. This descriptive study used a prospective, quantitative approach to obtain the feasibility and acceptability of a decision aid (DecisionKEYS for Balancing Choices) for use in clinical settings. It combined results of trials of patients with three different common malignancies. All groups used the same decision aid series. Participants included 80 patients with solid tumors (22 with newly diagnosed breast cancer, 19 with advanced prostate cancer, and 39 with advanced lung cancer) and their 80 supporters as well as their physicians and nurses, for a total of 160 participants and 10 health professionals. The decision aid was highly acceptable to patient and supporter participants in all diagnostic groups. It was feasible for use in clinic settings; the overall value was rated highly. Of six physicians, all found the interactive format with the help of the nurse as feasible and acceptable. Nurses also rated the decision aid favorably. This intervention provides the opportunity to enhance decision making about cancer treatment and warrants further study including larger and more diverse groups. Strengths of the study included a theoretical grounding, feasibility testing of a practical clinic-based intervention, and summative evaluation of acceptability of the intervention by patient and supporter pairs. Further research also is needed to test the effectiveness of the decision aid in diverse clinical settings and to determine if this intervention can decrease overall costs.

Recent Internet Use and Associations with Clinical Outcomes among Patients Entering Addiction Treatment Involved in a Web-Delivered Psychosocial Intervention Study.

PubMed

Tofighi, B; Campbell, A N C; Pavlicova, M; Hu, M C; Lee, J D; Nunes, E V

2016-10-01

The acceptability and clinical impact of a web-based intervention among patients entering addiction treatment who lack recent internet access are unclear. This secondary analysis of a national multisite treatment study (NIDA Clinical Trials Network-0044) assessed for acceptability and clinical impact of a web-based psychosocial intervention among participants enrolling in community-based, outpatient addiction treatment programs. Participants were randomly assigned to 12 weeks of a web-based therapeutic education system (TES) based on the community reinforcement approach plus contingency management versus treatment as usual (TAU). Demographic and clinical characteristics, and treatment outcomes were compared among participants with recent internet access in the 90 days preceding enrollment (N = 374) and without internet access (N = 133). Primary outcome variables included (1) acceptability of TES (i.e., module completion; acceptability of web-based intervention) and (2) clinical impact (i.e., self-reported abstinence confirmed by urine drug/breath alcohol tests; retention measured as time to dropout). Internet use was common (74 %) and was more likely among younger (18-49 years old) participants and those who completed high school (p < .001). Participants randomized to TES (n = 255) without baseline internet access rated the acceptability of TES modules significantly higher than those with internet access (t = 2.49, df = 218, p = .01). There was a near significant interaction between treatment, baseline abstinence, and internet access on time to dropout (χ 2 (1) = 3.8089, p = .051). TES was associated with better retention among participants not abstinent at baseline who had internet access (X 2 (1) = 6.69, p = .01). These findings demonstrate high acceptability of this web-based intervention among participants that lacked recent internet access.

The Impact of Multimedia Education on Uptake of Comprehensive Eye Examinations in Rural China: A Randomized, Controlled Trial.

PubMed

Dan, Aihua; Raubvogel, Graham; Chen, Tingting; Ye, Tiantian; Jin, Ling; Xiao, Baixiang; Sanchez, Ana; Congdon, Nathan

2015-01-01

To study the effect of multimedia education on acceptance of comprehensive eye examinations (CEEs), critical for detecting glaucoma and diabetic eye disease, among rural Chinese patients using a randomized, controlled design. Patients aged ≥40 years were recruited from 52 routine clinic sessions (26 intervention, 26 control) conducted at seven rural hospitals in Guangdong, China. Subjects answered demographic questionnaires, were tested on knowledge about CEEs and chronic eye disease, and were told the cost of examination (range US$0-8). At intervention sessions, subjects were cluster-randomized to view a 10-minute video on the value of CEEs and retested. Control subjects were not retested. Trial outcomes were acceptance of CEEs (primary outcome) and final knowledge scores (secondary outcome). At baseline, >70% (p = 0.70) of both intervention (n = 241, 61.2 ± 12.3 years) and control (n = 218, 58.4 ± 11.7 years) subjects answered no knowledge questions correctly, but mean scores on the test (maximum 5 points) increased by 1.39 (standard deviation 0.12) points (p < 0.001) after viewing the video. Intervention (73.0%) and control (72.9%) subjects did not differ in acceptance of CEEs (p > 0.50). In mixed-effect logistic regression models, acceptance of CEEs was associated with availability of free CEEs (odds ratio 18.3, 95% confidence interval 1.32-253.0), but not group assignment or knowledge score. Acceptance was 97.5% (79/81) when free exams were offered. Education increased knowledge about but not acceptance of CEEs, which was generally high. Making CEEs free could further increase acceptance.

Psychosocial determinants of physicians' acceptance of recommendations by antibiotic computerised decision support systems: A mixed methods study.

PubMed

Chow, Angela; Lye, David C B; Arah, Onyebuchi A

2015-03-01

Antibiotic computerised decision support systems (CDSSs) were developed to facilitate optimal prescribing, but acceptance of their recommendations has remained low. We aimed to evaluate physicians' perceptions and attitudes toward antibiotic CDSSs and determine psychosocial factors associated with acceptance of CDSS recommendations for empirical therapy. A mixed methods study was conducted in an adult tertiary-care hospital in Singapore, with its in-house antibiotic CDSS that integrates antimicrobial stewardship with electronic prescribing. Focus group discussions were conducted among purposively sampled physicians and data were analysed using the framework approach. Emerging themes were included in the questionnaire with newly developed scales for the subsequent cross-sectional survey involving all physicians. Principal components analysis was performed to derive the latent factor structure that was later applied in multivariate analyses. Physicians expressed confidence in the credibility of CDSS recommendations. Junior physicians accepted CDSS recommendations most of the time, whilst senior physicians acknowledged overriding recommendations in complex patients with multiple infections or allergies. Willingness to consult the CDSS for common and complex infections (OR=1.68, 95% CI 1.16-2.44) and preference for personal or team decision (OR=0.61, 95% CI 0.43-0.85) were associated with acceptance of CDSS recommendations. Cronbach's α for scales measuring physicians' attitudes and perceptions towards acceptance of CDSS recommendations ranged from 0.64 to 0.88. Physicians' willingness to consult an antibiotic CDSS determined acceptance of its recommendations. Physicians would choose to exercise their own or clinical team's decision over CDSS recommendations in complex patient situations when the antibiotic prescribing needs were not met. Copyright © 2014 Elsevier B.V. and the International Society of Chemotherapy. All rights reserved.

The student-run free clinic: an ideal site to teach interprofessional education?

PubMed

Sick, Brian; Sheldon, Lisa; Ajer, Katy; Wang, Qi; Zhang, Lei

2014-09-01

Student-run free clinics (SRFCs) often include an interprofessional group of health professions students and preceptors working together toward the common goal of caring for underserved populations. Therefore, it would seem that these clinics would be an ideal place for students to participate in an interprofessional collaborative practice and for interprofessional education to occur. This article describes a prospective, observational cohort study of interprofessional attitudes and skills including communication and teamwork skills and attitudes about interprofessional learning, relationships and interactions of student volunteers in a SRFC compared to students who applied and were not accepted to the clinic and to students who never applied to the clinic. This study showed a decrease in attitudes and skills after the first year for all groups. Over the next two years, the total score on the survey for the accepted students was higher than the not accepted students. The students who were not accepted also became more similar to students who never applied. This suggests a protective effect against declining interprofessional attitudes and skills for the student volunteers in a SRFC. These findings are likely a function of the design of the clinical and educational experience in the clinic and of the length of contact the students have with other professions.

A clinically feasible treatment protocol for magnetic resonance-guided high-intensity focused ultrasound ablation in the liver.

PubMed

Wijlemans, Joost W; de Greef, Martijn; Schubert, Gerald; Bartels, Lambertus W; Moonen, Chrit T W; van den Bosch, Maurice A A J; Ries, Mario

2015-01-01

Magnetic resonance-guided high-intensity focused ultrasound (MR-HIFU) allows for noninvasive thermal ablation under real-time temperature imaging guidance. The purpose of this study was to assess the feasibility and safety of MR-HIFU ablation of liver tissue in a clinically acceptable setting. The experimental protocol was designed with a clinical ablation procedure of a small malignant tumor in mind; the procedures were performed within a clinically feasible time frame and care was taken to avoid adverse events. The main outcome was the size and quality of the ablated liver tissue volume on imaging and histology. Secondary outcomes were safety and treatment time. Healthy pigs (n = 10) under general anesthesia were positioned on a clinical MR-HIFU system, which consisted of an HIFU tabletop with a skin cooling system integrated into a 1.5-T MR scanner. A liver tissue volume was ablated with multiple sonication cells (4 × 4 × 10 mm, 450 W). Both MR thermometry and sonication were respiratory-gated using a pencil beam navigator on the diaphragm. Contrast-enhanced T1-weighted (CE-T1w) imaging was performed for treatment evaluation. Targeted total treatment time was 3 hours. The abdominal wall, liver, and adjacent organs were inspected postmortem for thermal damage. Ablated tissue volumes were processed for cell viability staining. The ablated volumes were analyzed using MR imaging, MR thermometry, and cell viability histology. Eleven volume ablations were performed in 10 animals, resulting in a median nonperfused volume (NPV) on CE-T1w imaging of 1.6 mL (interquartile range [IQR], 0.8-2.3; range, 0.7-3.0). Cell viability histology showed a damaged volume of 1.5 mL (IQR, 1.1-1.8; range, 0.7-2.3). The NPV was confluent in 10 of the 11 cases. The ablated tissue volume on cell viability histology was confluent in all 9 available cases. In all cases, there was a good correspondence between the aspects of the NPV on CE-T1w and the ablated volume on cell viability histology. Two treatment-related adverse events occurred: 1 animal had a 7-mm skin burn and 1 animal showed evidence of thermal damage on the surface of the spleen. Median ablation time was 108 minutes (IQR, 101-120; range, 96-181 minutes) and median total treatment time was 180 minutes (IQR, 165-224; 130-250 minutes). Our results demonstrate the feasibility and safety of MR-HIFU ablation of liver tissue volumes. The imaging data and cell viability histology show, for the first time, that confluent ablation volumes can be achieved with motion-gated ablation and MR guidance. These results were obtained using a readily available MR-HIFU system with only minor modifications, within a clinically acceptable time frame, and with only minor adverse events. This shows that this technique is sufficiently reliable and safe to initiate a clinical trial.

Safety and efficacy of intravitreal bevacizumab followed by pegaptanib maintenance as a treatment regimen for age-related macular degeneration.

PubMed

Hughes, Mark S; Sang, Delia N

2006-01-01

Vascular endothelial growth factor (VEGF)-A, both necessary and sufficient in promoting ocular neovascularization, is an attractive therapeutic target. Combining nonselective and selective VEGF blockade may provide clinical benefit with minimal risks in the treatment of neovascular age-related macular degeneration (AMD). Twenty patients with all subtypes of neovascular AMD and a broad range of baseline vision were treated with intravitreal bevacizumab followed by pegaptanib sodium for 54 weeks. Visual acuity measurements, biomicroscopy, funduscopy, fluorescein angiography, optical coherence tomography, and adverse event assessments were performed. Mean visual acuity improved from approximately 20/200 at baseline to 20/80. All patients experienced an improvement in retinal thickness, ranging from -47 to -297 microns. Adverse events were limited to transient irritation or redness. No significant elevation in intraocular pressure occurred following either bevacizumab or pegaptanib injections. Nonselective VEGF blockade with bevacizumab induction and selective VEGF165 blockade with pegaptanib as maintenance therapies may offer clinically meaningful outcomes with acceptable safety profiles in patients with AMD.

Validation of the Female Sexual Function Index (FSFI) in Women with Female Orgasmic Disorder and in Women with Hypoactive Sexual Desire Disorder

PubMed Central

Meston, Cindy M.

2010-01-01

The Female Sexual Functioning Index (FSFI; Rosen et al., 2000) is a self-report measure of sexual functioning that has been validated on a clinically diagnosed sample of women with female sexual arousal disorder. The present investigation extended the validation of the FSFI to include women with a primary clinical diagnosis of female orgasmic disorder (FOD; n = 71) or hypoactive sexual desire disorder (HSDD; n = 44). Internal consistency and divergent validity of the FSFI were within the acceptable range for these populations of women. Significant differences between women with FOD and controls and between women with HSDD and controls were noted for each of the FSFI domain and total scores. PMID:12519665

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.

The FORGE AHEAD clinical readiness consultation tool: a validated tool to assess clinical readiness for chronic disease care mobilization in Canada's First Nations.

PubMed

Hayward, Mariam Naqshbandi; Mequanint, Selam; Paquette-Warren, Jann; Bailie, Ross; Chirila, Alexandra; Dyck, Roland; Green, Michael; Hanley, Anthony; Tompkins, Jordan; Harris, Stewart

2017-03-23

Given the astounding rates of diabetes and related complications, and the barriers to providing care present in Indigenous communities in Canada, intervention strategies that take into account contextual factors such as readiness to mobilize are needed to maximize improvements and increase the likelihood of success and sustainment. As part of the national FORGE AHEAD Program, we sought to develop, test and validate a clinical readiness consultation tool aimed at assessing the readiness of clinical teams working on-reserve in First Nations communities to participate in quality improvement (QI) to enhance diabetes care in Canada. A literature review was conducted to identify existing readiness tools. The ABCD - SAT was adapted using a consensus approach that emphasized a community-based participatory approach and prioritized the knowledge and wisdom held by community members. The tool was piloted with a group of 16 people from 7 provinces and 11 partnering communities to assess language use, clarity, relevance, format, and ease of completion using examples. Internal reliability analysis and convergence validity were conducted with data from 53 clinical team members from 11 First Nations communities (3-5 per community) who have participated in the FORGE AHEAD program. The 27-page Clinical Readiness Consultation Tool (CRCT) consists of five main components, 21 sub-components, and 74 items that are aligned with the Expanded Chronic Care Model. Five-point Likert scale feedback from the pilot ranged from 3.25 to 4.5. Length of the tool was reported as a drawback but respondents noted that all the items were needed to provide a comprehensive picture of the healthcare system. Results for internal consistency showed that all sub-components except for two were within acceptable ranges (0.77-0.93). The Team Structure and Function sub-component scale had a moderately significant positive correlation with the validated Team Climate Inventory, r = 0.45, p < 0.05. The testing and validation of the FORGE AHEAD CRCT demonstrated that the tool is acceptable, valid and reliable. The CRCT has been successfully used to support the implementation of the FORGE AHEAD Program and the health services changes that partnering First Nations communities have designed and undertaken to improve diabetes care. Current ClinicalTrial.gov protocol ID NCT02234973 . Date of Registration: July 30, 2014.

Clinical nurses' attitudes towards death and caring for dying patients in China.

PubMed

Wang, Liping; Li, Chaxiang; Zhang, Qiongling; Li, YaJie

2018-01-02

To examine Chinese clinical nurses' attitudes towards death and caring for dying patients, and to examine the relationships between clinical nurses' attitudes towards death and caring for dying patients. A convenience sample of 770 clinical nurses from 15 hospitals in China. All participants completed the Chinese version of the Frommelt Attitude Toward Care of the Dying Scale, Form B (FATCOD-B-C), the Chinese version of the Death Attitude Profile-Revised (DAP-R-C), and a demographic questionnaire. The mean score of the FATCOD-B-C items was 95.62 (SD = 7.45). The majority of Chinese clinical nurses were likely to provide care for the dying person's family (mean = 3.77), but did not have a positive attitude towards communication with the dying person(mean = 2.62). The majority of Chinese clinical nurses showed low scores on death avoidance (mean=1.96) and natural acceptance (mean = 1.61), and most of them viewed death as a passageway to a happy afterlife (mean = 4.33). Attitudes towards caring for dying patients were significantly negatively correlated with fear of death (r = -0.120) and positively correlated with approach acceptance (r = 0.127) and natural acceptance (r = 0.117). Factors that predicted clinical nurses' attitudes towards the care of dying patients included education level, fear of death, approach acceptance, religious beliefs, previous education on death and dying, natural acceptance, professional title, and experience with death or dying patients, which accounted for 18.7% of the variance. Nurses' personal attitudes towards death were associated with their attitudes towards the care of dying patients. Training and educational programmes for clinical nurses should take into consideration nurses' personal attitudes towards death as well as their cultural backgrounds and religious beliefs.

Psychological Flexibility as a Buffer against Caregiver Distress in Families with Psychosis.

PubMed

Jansen, Jens E; Haahr, Ulrik H; Lyse, Hanne-Grethe; Pedersen, Marlene B; Trauelsen, Anne M; Simonsen, Erik

2017-01-01

Background: Research has shown that caregivers of persons with psychosis play an invaluable role in recovery, but unfortunately, often report high levels of distress. While cognitive models of caregiver distress have been well-supported, there is still limited knowledge of the psychological factors involved. Recent advances in cognitive behavioral therapy seem to converge on the importance of acceptance- and mindfulness based processes. Aim: To examine the impact of psychological flexibility on caregiver distress in the early phases of psychosis, while controlling for known predictors of caregiver distress. Method: Within a cross-sectional design, 101 caregivers of 38 persons with first-episode psychosis in a clinical epidemiological sample completed a series of self-report measures. Results: A linear mixed model analysis found that, after controlling for caregiver socio-demographic factors, service user symptoms, drug use and global functioning, psychological flexibility was a significant predictor of caregiver distress. Conclusion: Greater level of psychological flexibility in caregivers, seems to be related to lower levels of caregiver distress. This finding corresponds to studies within a broad range of emotional disorders. There may be important clinical implications in terms of facilitating the process of acceptance through interventions from the 'third-wave' or contextual cognitive behavioral therapies.

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

PubMed

Stephen-Haynes, Jackie; Stephens, Claire

2013-12-01

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

Children's experience of living with a craniofacial condition: perspectives of children and parents.

PubMed

Roberts, Rachel M; Shute, Rosalyn

2011-07-01

This is the first study to examine the range of experiences of children living with a wide range of craniofacial anomalies (CFAs), from the perspectives of children and parents. We interviewed 26 young people and 28 parents about both stressors and positive aspects for young people of living with a CFA. Thematic analysis revealed four major stress-related themes (self-acceptance, responses of others, disabilities and impairments, and treatment). Positive themes included personal qualities and support. Psychological theories often applied to those with CFAs relate to attractiveness, stigma and teasing, but the present findings suggest that these are not as useful as the conceptualization of CFAs as chronic conditions which influence adaptive tasks. Implications for clinical practice are discussed.

Non-invasive, non-radiological quantification of anteroposterior knee joint ligamentous laxity

PubMed Central

Russell, D. F.; Deakin, A. H.; Fogg, Q. A.; Picard, F.

2013-01-01

Objectives We performed in vitro validation of a non-invasive skin-mounted system that could allow quantification of anteroposterior (AP) laxity in the outpatient setting. Methods A total of 12 cadaveric lower limbs were tested with a commercial image-free navigation system using trackers secured by bone screws. We then tested a non-invasive fabric-strap system. The lower limb was secured at 10° intervals from 0° to 60° of knee flexion and 100 N of force was applied perpendicular to the tibia. Acceptable coefficient of repeatability (CR) and limits of agreement (LOA) of 3 mm were set based on diagnostic criteria for anterior cruciate ligament (ACL) insufficiency. Results Reliability and precision within the individual invasive and non-invasive systems was acceptable throughout the range of flexion tested (intra-class correlation coefficient 0.88, CR 1.6 mm). Agreement between the two systems was acceptable measuring AP laxity between full extension and 40° knee flexion (LOA 2.9 mm). Beyond 40° of flexion, agreement between the systems was unacceptable (LOA > 3 mm). Conclusions These results indicate that from full knee extension to 40° flexion, non-invasive navigation-based quantification of AP tibial translation is as accurate as the standard validated commercial system, particularly in the clinically and functionally important range of 20° to 30° knee flexion. This could be useful in diagnosis and post-operative evaluation of ACL pathology. Cite this article: Bone Joint Res 2013;2:233–7. PMID:24184443

Medical students in gynaecology clinics.

PubMed

Yang, Jenny; Black, Kirsten

2014-07-01

This study aimed to investigate factors that influence a patient's acceptance of a medical student's involvement in their consultation when attending a public hospital gynaecology clinic. Factors that influence a patient's acceptance of a medical student's involvement in a consultation This was an observational study of women attending gynaecology clinics at Royal Prince Alfred Hospital (RPAH) from January to December 2011. The questionnaire sought demographic information and asked women about their knowledge of medical student attendance at the clinics, if they would allow a student to be present during their consultation and whether they would allow a student to examine them. It also sought reasons for their responses. Of the 460 questionnaires distributed, 97 per cent (446) were completed. Overall, 85.6 per cent (382) of patients expressed an acceptance of medical students being present in their consultation, and 63.9 per cent (285) said they would allow students to examine them. Factors significantly associated with an increased acceptance of examination by medical students included being aware that a student may be present (p=0.003), and being married or in a committed relationship (p=0.023). Age and education level were not significantly associated with acceptance of being examined by a student, and ethnicity was too diverse to assess any possible bias. All groups maintained a preference for female students. This study has found that being aware that medical students may be present in gynaecology clinics may increase patient acceptance of being examined by a student. This demonstrates a role for information to be distributed to patients prior to their appointment to facilitate medical training. © 2014 John Wiley & Sons Ltd.

Rasch-Transformed Total Neuropathy Score clinical version (RT-TNSc(©) ) in patients with chemotherapy-induced peripheral neuropathy.

PubMed

Binda, Davide; Cavaletti, Guido; Cornblath, David R; Merkies, Ingemar S J

2015-09-01

Composite scales such as the Total Neuropathy Score clinical version (TNSc(©) ) have been widely used to measure neurological impairment in a standardized manner but they have been criticized due to their ordinal setting having no fixed unit. This study aims to improve impairment assessment in patients with chemotherapy-induced peripheral neuropathy (CIPN) by subjecting TNSc(©) records to Rasch analyses. In particular, we wanted to investigate the influence of factors affecting the use of the TNSc(©) in clinical practice. TNSc(©) has 7 domains (sensory, motor, autonomic, pin-prick, vibration, strength, and deep tendon reflexes [DTR]) each being scored 0-4. Data obtained in 281 patients with stable CIPN were subjected to Rasch analyses to determine the fit to the model. The TNSc(©) did not meet Rasch model's expectations primarily because of misfit statistics in autonomic and DTR domains. Removing these two, acceptable model fit and uni-dimensionality were obtained. However, disordered thresholds (vibration and strength) and item bias (mainly cultural) were still seen, but these findings were kept to balance the assessment range of the Rasch-Transformed TNSc(©) (RT-TNSc(©) ). Acceptable reliability findings were also obtained. A 5-domains RT-TNSc(©) may be a more proper assessment tool in patients with CIPN. Future studies are needed to examine its responsive properties. © 2015 Peripheral Nerve Society.

CT protocol management: simplifying the process by using a master protocol concept

PubMed Central

Bour, Robert K.; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N.

2015-01-01

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two‐tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade‐offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be adapted among different clinical indications on a single scanner and among different CT scanners. PACS number: 87.57.Q PMID:26219005

Quality by design for herbal drugs: a feedforward control strategy and an approach to define the acceptable ranges of critical quality attributes.

PubMed

Yan, Binjun; Li, Yao; Guo, Zhengtai; Qu, Haibin

2014-01-01

The concept of quality by design (QbD) has been widely accepted and applied in the pharmaceutical manufacturing industry. There are still two key issues to be addressed in the implementation of QbD for herbal drugs. The first issue is the quality variation of herbal raw materials and the second issue is the difficulty in defining the acceptable ranges of critical quality attributes (CQAs). To propose a feedforward control strategy and a method for defining the acceptable ranges of CQAs for the two issues. In the case study of the ethanol precipitation process of Danshen (Radix Salvia miltiorrhiza) injection, regression models linking input material attributes and process parameters to CQAs were built first and an optimisation model for calculating the best process parameters according to the input materials was established. Then, the feasible material space was defined and the acceptable ranges of CQAs for the previous process were determined. In the case study, satisfactory regression models were built with cross-validated regression coefficients (Q(2) ) all above 91 %. The feedforward control strategy was applied successfully to compensate the quality variation of the input materials, which was able to control the CQAs in the 90-110 % ranges of the desired values. In addition, the feasible material space for the ethanol precipitation process was built successfully, which showed the acceptable ranges of the CQAs for the concentration process. The proposed methodology can help to promote the implementation of QbD for herbal drugs. Copyright © 2013 John Wiley & Sons, Ltd.

Computer-socket manufacturing error: How much before it is clinically apparent?

PubMed Central

Sanders, Joan E.; Severance, Michael R.; Allyn, Kathryn J.

2015-01-01

The purpose of this research was to pursue quality standards for computer-manufacturing of prosthetic sockets for people with transtibial limb loss. Thirty-three duplicates of study participants’ normally used sockets were fabricated using central fabrication facilities. Socket-manufacturing errors were compared with clinical assessments of socket fit. Of the 33 sockets tested, 23 were deemed clinically to need modification. All 13 sockets with mean radial error (MRE) greater than 0.25 mm were clinically unacceptable, and 11 of those were deemed in need of sizing reduction. Of the remaining 20 sockets, 5 sockets with interquartile range (IQR) greater than 0.40 mm were deemed globally or regionally oversized and in need of modification. Of the remaining 15 sockets, 5 sockets with closed contours of elevated surface normal angle error (SNAE) were deemed clinically to need shape modification at those closed contour locations. The remaining 10 sockets were deemed clinically acceptable and not in need modification. MRE, IQR, and SNAE may serve as effective metrics to characterize quality of computer-manufactured prosthetic sockets, helping facilitate the development of quality standards for the socket manufacturing industry. PMID:22773260

Developing a Cognition Endpoint for Traumatic Brain Injury Clinical Trials

PubMed Central

Crane, Paul K.; Dams-O'Connor, Kristen; Holdnack, James; Ivins, Brian J.; Lange, Rael T.; Manley, Geoffrey T.; McCrea, Michael; Iverson, Grant L.

2017-01-01

Abstract Cognitive impairment is a core clinical feature of traumatic brain injury (TBI). After TBI, cognition is a key determinant of post-injury productivity, outcome, and quality of life. As a final common pathway of diverse molecular and microstructural TBI mechanisms, cognition is an ideal endpoint in clinical trials involving many candidate drugs and nonpharmacological interventions. Cognition can be reliably measured with performance-based neuropsychological tests that have greater granularity than crude rating scales, such as the Glasgow Outcome Scale-Extended, which remain the standard for clinical trials. Remarkably, however, there is no well-defined, widely accepted, and validated cognition endpoint for TBI clinical trials. A single cognition endpoint that has excellent measurement precision across a wide functional range and is sensitive to the detection of small improvements (and declines) in cognitive functioning would enhance the power and precision of TBI clinical trials and accelerate drug development research. We outline methodologies for deriving a cognition composite score and a research program for validation. Finally, we discuss regulatory issues and the limitations of a cognition endpoint. PMID:27188248

Challenges of PhD Graduated Nurses for Role Acceptance as a Clinical Educator: A Qualitative Study.

PubMed

Haghighi Moghadam, Yousef; Atashzadeh-Shoorideh, Foroozan; Abbaszadeh, Abbas; Feizi, Aram

2017-06-01

Introduction: Clinical education is the core component of nursing education. PhD graduated nurses who are faculty members can play a main role in clinical instruction. However, there is not clear understanding about the challenges which they may encounter for accepting their role as clinical educator. The aim of this study was to explore the challenges of role acceptance by PhD aduated nurses who are faculty members. Methods: In this qualitative exploratory study a total of 13 participants (8 PhD graduated in nursing, 3 head of departments of nursing, one educational vice chancellor of nursing school, and one nurse) were selected by purposive sampling method. Data were collected by semi-structured, face to face interview and analyzed by conventional content analysis approach developed by Graneheim and Lundman. Results: The main theme emerged from data analysis was "identity threat". This theme had five categories including expectations beyond ability, lack of staff's rely on the performance of PhD graduated nurses, poor clinical competencies, doubtfulness, and obligation. Conclusion: PhD graduated nurses experienced some worries about their role as clinical educators and argued that they have not been prepared for their role. Therefore, policy makers and authorities of nursing schools should support PhD graduated nurses for accepting their new roles as clinical educators. Moreover, some changes in nursing PhD curriculum is needed to improve the clinical competencies of PhD graduated and prepare them for their role as a clinical educator.

Challenges of PhD Graduated Nurses for Role Acceptance as a Clinical Educator: A Qualitative Study

PubMed Central

Haghighi Moghadam, Yousef; Atashzadeh-Shoorideh, Foroozan; Abbaszadeh, Abbas; Feizi, Aram

2017-01-01

Introduction: Clinical education is the core component of nursing education. PhD graduated nurses who are faculty members can play a main role in clinical instruction. However, there is not clear understanding about the challenges which they may encounter for accepting their role as clinical educator. The aim of this study was to explore the challenges of role acceptance by PhD aduated nurses who are faculty members. Methods: In this qualitative exploratory study a total of 13 participants (8 PhD graduated in nursing, 3 head of departments of nursing, one educational vice chancellor of nursing school, and one nurse) were selected by purposive sampling method. Data were collected by semi-structured, face to face interview and analyzed by conventional content analysis approach developed by Graneheim and Lundman. Results: The main theme emerged from data analysis was "identity threat". This theme had five categories including expectations beyond ability, lack of staff’s rely on the performance of PhD graduated nurses, poor clinical competencies, doubtfulness, and obligation. Conclusion: PhD graduated nurses experienced some worries about their role as clinical educators and argued that they have not been prepared for their role. Therefore, policy makers and authorities of nursing schools should support PhD graduated nurses for accepting their new roles as clinical educators. Moreover, some changes in nursing PhD curriculum is needed to improve the clinical competencies of PhD graduated and prepare them for their role as a clinical educator. PMID:28680869

Screening of the spine in adolescents: inter- and intra-rater reliability and measurement error of commonly used clinical tests.

PubMed

Aartun, Ellen; Degerfalk, Anna; Kentsdotter, Linn; Hestbaek, Lise

2014-02-10

Evidence on the reliability of clinical tests used for the spinal screening of children and adolescents is currently lacking. The aim of this study was to determine the inter- and intra-rater reliability and measurement error of clinical tests commonly used when screening young spines. Two experienced chiropractors independently assessed 111 adolescents aged 12-14 years who were recruited from a primary school in Denmark. A standardised examination protocol was used to test inter-rater reliability including tests for scoliosis, hypermobility, general mobility, inter-segmental mobility and end range pain in the spine. Seventy-five of the 111 subjects were re-examined after one to four hours to test intra-rater reliability. Percentage agreement and Cohen's Kappa were calculated for binary variables, and interclass correlation (ICC) and Bland-Altman plots with Limits of Agreement (LoA) were calculated for continuous measures. Inter-rater percentage agreement for binary data ranged from 59.5% to 100%. Kappa ranged from 0.06-1.00. Kappa ≥ 0.40 was seen for elbow, thumb, fifth finger and trunk/hip flexion hypermobility, pain response in inter-segmental mobility and end range pain in lumbar flexion and extension. For continuous data, ICCs ranged from 0.40-0.95. Only forward flexion as measured by finger-to-floor distance reached an acceptable ICC(≥ 0.75). Overall, results for intra-rater reliability were better than for inter-rater reliability but for both components, the LoA were quite wide compared with the range of assessments. Some clinical tests showed good, and some tests poor, reliability when applied in a spinal screening of adolescents. The results could probably be improved by additional training and further test standardization. This is the first step in evaluating the value of these tests for the spinal screening of adolescents. Future research should determine the association between these tests and current and/or future neck and back pain.

[Evaluation of DCA vantage for rapid in-clinic measurement of HbA1c on capillary blood in young type 1 diabetic patients].

PubMed

El Arabi, H; Willems, D; Mélot, C; Dorchy, H

2013-01-01

Rapid in clinic measurement of glycated hemoglogin (HbA1c) allows to determine the level of metabolic control within a few minutes on capillary blood. We have evaluated the new DCA Vantage (Siemens) based on an immunological technique, replacing the DCA 2000+ (Siemens). The study included 120 unselected young type 1 diabetic patients, with different degrees of metabolic control. The DCA Vantage was compared with the HPLC system (Menarini HA 8160) whose deviation from the DCCT was < 0.1% across the clinical range. The mean underestimation of the DCA Vantage was -0.40%. The agreement limits (+/- 1.96 SD) were between 0.14% and -0.93%; this means +/- 0.53% around -0.40%. In conclusion, the DCA Vantage underestimates HbA1c levels; however it met the acceptance criteria of having a coefficient of variation < 3%.

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

Baker, Erin Shammel; Burnum-Johnson, Kristin E.; Jacobs, Jon M.

Rapid diagnosis of disease states using less invasive, safer, and more clinically acceptable approaches than presently employed is an imperative goal for the field of medicine. While mass spectrometry (MS)-based proteomics approaches have attempted to meet these objectives, challenges such as the enormous dynamic range of protein concentrations in clinically relevant biofluid samples coupled with the need to address human biodiversity have slowed their employment. Herein, we report on the use of a new platform that addresses these challenges by coupling technical advances in rapid gas phase multiplexed ion mobility spectrometry (IMS) separations [1, 2] with liquid chromatography (LC) andmore » MS to dramatically increase measurement sensitivity and throughput, further enabling future MS-based clinical applications. An initial application of the LC-IMS-MS platform for the analysis of blood serum samples from stratified post-liver transplant patients with recurrent fibrosis progression illustrates its potential utility for disease characterization and use in personalized medicine [3, 4].« less

Quality-control issues on high-resolution diagnostic monitors.

PubMed

Parr, L F; Anderson, A L; Glennon, B K; Fetherston, P

2001-06-01

Previous literature indicates a need for more data collection in the area of quality control of high-resolution diagnostic monitors. Throughout acceptance testing, which began in June 2000, stability of monitor calibration was analyzed. Although image quality on all monitors was found to be acceptable upon initial acceptance testing using VeriLUM software by Image Smiths, Inc (Germantown, MD), it was determined to be unacceptable during the clinical phase of acceptance testing. High-resolution monitors were evaluated for quality assurance on a weekly basis from installation through acceptance testing and beyond. During clinical utilization determination (CUD), monitor calibration was identified as a problem and the manufacturer returned and recalibrated all workstations. From that time through final acceptance testing, high-resolution monitor calibration and monitor failure rate remained a problem. The monitor vendor then returned to the site to address these areas. Monitor defocus was still noticeable and calibration checks were increased to three times per week. White and black level drift on medium-resolution monitors had been attributed to raster size settings. Measurements of white and black level at several different size settings were taken to determine the effect of size on white and black level settings. Black level remained steady with size change. White level appeared to increase by 2.0 cd/m2 for every 0.1 inches decrease in horizontal raster size. This was determined not to be the cause of the observed brightness drift. Frequency of calibration/testing is an issue in a clinical environment. The increased frequency required at our site cannot be sustained. The medical physics division cannot provide dedicated personnel to conduct the quality-assurance testing on all monitors at this interval due to other physics commitments throughout the hospital. Monitor access is also an issue due to radiologists' need to read images. Some workstations are in use 7 AM to 11 PM daily. An appropriate monitor calibration frequency must be established during acceptance testing to ensure unacceptable drift is not masked by excessive calibration frequency. Standards for acceptable black level and white level drift also need to be determined. The monitor vendor and hospital staff agree that currently, very small printed text is an acceptable method of determining monitor blur, however, a better method of determining monitor blur is being pursued. Although monitors may show acceptable quality during initial acceptance testing, they need to show sustained quality during the clinical acceptance-testing phase. Defocus, black level, and white level are image quality concerns, which need to be evaluated during the clinical phase of acceptance testing. Image quality deficiencies can have a negative impact on patient care and raise serious medical-legal concerns. The attention to quality control required of the hospital staff needs to be realistic and not have a significant impact on radiology workflow.

Determination of minimum suction level necessary for field dental units.

PubMed

Charlton, David G

2010-04-01

A significant problem with most field dental units is that their suction is too weak to effectively remove debris from the mouth. The purpose of this study was to determine the minimum clinically acceptable suction level for routine dentistry. A vacuum pump was connected to a high-volume dental evacuation line in a simulated clinical setting and different suction airflow rates were evaluated by nine evaluator dentists for their capability to effectively remove amalgam debris and water. Airflow levels were rated as "clinically acceptable" or "clinically unacceptable" by each evaluator. Data were analyzed using a chi2 test for trend. Analysis indicated a significant linear trend between airflow and ratings (p < 0.0001). The first airflow level considered by all evaluators as producing clinically acceptable suction was 4.5 standard cubic feet per minute (0.127 standard cubic meters per minute). This value should be the minimum level required for all military field dental units.

The training needs of Turkish emergency department personnel regarding intimate partner violence

PubMed Central

Aksan, H Asli Davas; Aksu, Feride

2007-01-01

Background Violence against females is a widespread public health problem in Turkey and the lifetime prevalence of IPV ranges between 34 and 58.7%. Health care workers (HCW) sometimes have the unique opportunity and obligation to identify, treat, and educate females who are abused. The objective of this study was to evaluate the knowledge, attitudes, and experiences of the emergency department (ED) staff regarding intimate partner violence (IPV) at a large university hospital in Turkey. Methods A cross-sectional study was conducted in a large university hospital via questionnaire. The study population consisted of all the nurses and physicians who worked in the ED during a two month period (n = 215). The questionnaire response rate was 80.5% (41 nurses and 132 physicians). The main domains of the questionnaire were knowledge regarding the definition of IPV, clinical findings in victims of IPV, legal aspects of IPV, attitudes towards IPV, knowledge about the characteristics of IPV victims and abusers, and professional and personal experiences and training with respect to IPV. Results One-half of the study group were females, 76.3% were physicians, and 89.8% had no training on IPV. The majority of the nurses (89.5%) and physicians (71.1%) declared that they were aware of the clinical appearance of IPV. The mean of the knowledge scores on clinical knowledge were 8.84 ± 1.73 (range, 0–10) for acute conditions, and 4.51 ± 3.32 for chronic conditions. The mean of the knowledge score on legal procedures and the legal rights of the victims was 4.33 ± 1.66 (range, 0–7). At least one reason to justify physical violence was accepted by 69.0% of females and 84.7% of males, but more males than females tended to justify violence (chi square = 5.96; p = 0.015). However, both genders accepted that females who experienced physical violence should seek professional medical help. Conclusion The study participants' knowledge about IPV was rather low and a training program is thus necessary on this issue. Attention must be given to the legal aspects and clinical manifestations of IPV. The training program should also include a module on gender roles in order to improve the attitudes towards IPV. PMID:18078505

Prevalence of venous obstruction in permanent endovenous pacing in newborns and infants: follow-up study.

PubMed

Stojanov, Petar; Vranes, Mile; Velimirovic, Dusan; Zivkovic, Mirjana; Kocica, Mladen J; Davidovic, Lazar; Neskovic, Voislava; Stajevic, Mila

2005-05-01

We examined the prevalence of venous obstruction in 12 newborns and infants with permanent endovenous ventricular pacing, clinically, and by ultrasonographic assessment of hemodynamics (spontaneity, phasicity, velocity, and turbulence of flow) and morphologic parameters (compressibility, wall thickness, and thrombus presence). All implantations of single ventricular unipolar endovenous steroid leads, were performed via cephalic vein, and pacemakers were placed in subcutaneous pocket in right prepectoral region. After the vascular surgeon has carefully examined all children for presence of venous collaterals in the chest wall, morphologic and hemodynamic parameters of the subclavian, axillary, and internal jugular veins, were assessed by linear-array color Doppler. Lead capacity (LC) was calculated for each patient. Mean age of patients at implant was 6.2 months (range 1 day-12 months), mean weight 6.5 kg (range 2.25-10 kg), and mean height 60.9 cm (range 48-78 cm). Mean LC was 1.99 (range 1.14-3.07). Total follow-up was 1023 and mean follow-up 85.2 pacing months (range 3-156). No clinical signs of venous obstruction were observed. Mild stenosis (20%) of subclavian vein was found by color Doppler in 2/12 patients. Both had adequate lead diameter for body surface. Permanent endovenous pacing is a feasible procedure, even in children of body weight less than 10 kg, with quite acceptable impact on venous system patency.

Optimizing information technology to improve sexual health-care delivery: public and patient preferences.

PubMed

Ross, J D C; Copas, A; Stephenson, J; Fellows, L; Gilleran, G

2007-07-01

Information and communication technology (ICT) has the potential to improve the quality of care and efficiency in sexual health clinics, but its introduction requires input not only from health-care professionals and ICT specialists but also from service users and potential future users. In this study, views on ICT in relation to the delivery of sexual health services were assessed using a structured interview in two groups - a community sample of young people and a clinic sample of existing patients. In all, 542 community interviewees and 202 clinic patients participated. About 75% of respondents had access to the Internet and overall 60% reported that the self-collection of a sexual history on an electronic form was acceptable. Black Caribbean individuals had significantly less access to the Internet and a lower acceptance of electronic data collection. For booking an appointment, the majority of patients reported the telephone (community sample 93%, clinic sample 96%) or attending in person (community sample 77%, clinic sample 54%) to be acceptable, with a smaller proportion choosing email (community sample 10%, clinic sample 27%) or the Internet (community sample 7%, clinic sample 11%). Electronic booking was significantly less acceptable to Black Caribbean respondents. Although new technologies offer the opportunity to improve the quality of sexual health services, patient preferences and differences between groups in access to technology also need to be considered when services are reconfigured.

Outcomes research in cancer clinical trial cooperative groups: the RTOG model.

PubMed

Bruner, D W; Movsas, B; Konski, A; Roach, M; Bondy, M; Scarintino, C; Scott, C; Curran, W

2004-08-01

The Radiation Therapy Oncology Group (RTOG), a National Cancer Institute sponsored cancer clinical trials research cooperative, has recently formed an Outcomes Committee to assess a comprehensive array of clinical trial endpoints and factors impacting the net effect of therapy. To study outcomes in a consistent, comprehensive and coordinated manner, the RTOG Outcomes Committee developed a model to assess clinical, humanistic, and economic outcomes important in clinical trials. This paper reviews how the RTOG incorporates outcomes research into cancer clinical trials, and demonstrates utilization of the RTOG Outcomes Model to test hypotheses related to non-small-cell lung cancer (NSCLC). In this example, the clinical component of the model indicates that the addition of chemotherapy to radiotherapy (RT) improves survival but increases the risk of toxicity. The humanistic component indicates that esophagitis is the symptom impacting quality of life the greatest and may outweigh the benefits in elderly (> or =70 years) patients. The economic component of the model indicates that accounting for quality-adjusted survival, concurrent chemoRT for the treatment of NSCLC is within the range of economically acceptable recommendations. The RTOG Outcomes Model guides a comprehensive program of research that systematically measures a triad of endpoints considered important to clinical trials research.

Anesthetic gas exposure in veterinary clinics.

PubMed

Korczynski, R E

1999-06-01

Concerns were raised by several workers from veterinary clinics in Manitoba, Canada, regarding potential exposure to isoflurane and halothane during anesthetic administration. There has been no guideline established for isoflurane by the American Conference of Governmental Industrial Hygienist (ACGIH) or a Permissible Exposure Limit by the Occupational Safety and Health Administration (OSHA) or a recommended exposure limit (REL) by the National Institute for Occupational Safety and Health (NIOSH). The ACGIH TLV-TWA for halothane is 50 ppm and NIOSH has established 2 ppm as a recommended level based on an one-hour sampling. OSHA has established no guideline for halothane. The Miran IB Portable Ambient Air Analyzer was used to conduct real-time sampling and to identify leaks during administration. All veterinary clinics inspected had installed the passive waste gas scavenging system. Ten clinics were each monitored during anesthetic gas delivery for one surgical procedure performed. Induction was 4 to 5 percent and maintenance 1.5 to 2.5 percent. Nine clinics were small animal practices and the tenth was an equine clinic. Veterinarians' personal exposures were higher than the assistants'. Veterinarians' personal exposures for isoflurane ranged from 1.3 to 13 ppm (AM = 5.3; SD +/- 2.7; GM = 4.6; GSD +/- 1.6) and for their assistants, personal exposures ranged from 1.2 to 9 ppm (AM = 4.7; SD +/- 2.5; GM = 3.9; GSD +/- 1.6). Veterinarians' personal exposures for halothane ranged from 0.7 to 12 ppm (AM = 4.2; SD +/- 3.6; GM = 2.9; GSD +/- 1.4) and for their assistants, personal exposures ranged from 0.4 to 3.2 ppm (AM = 1.8; SD +/- 1.0; GM = 1.5; GSD +/- 1.7). One clinic had significant leaks in the anesthetic gas delivery lines. Personal halothane exposure for the veterinarian at this clinic was 7.2 to 65 ppm (AM = 18.0; SD +/- 11.5; GM = 15.9; GSD +/- 1.8). Based on this study, worker exposures were acceptable. Peak exposures were recorded when the cuffed endotracheal tube was removed from the animal. Equipment leaks were minimal when the system was maintained at its optimum operating condition.

Exploring psychological mechanisms of clinical response to an internet-delivered psychological pain management program.

PubMed

Gandy, M; Karin, E; Jones, M P; McDonald, S; Sharpe, L; Titov, N; Dear, B F

2018-05-13

The evidence for Internet-delivered pain management programs for chronic pain is growing, but there is little empirical understanding of how they effect change. Understanding mechanisms of clinical response to these programs could inform their effective development and delivery. A large sample (n = 396) from a previous randomized controlled trial of a validated internet-delivered psychological pain management program, the Pain Course, was used to examine the influence of three potential psychological mechanisms (pain acceptance, pain self-efficacy, fear of movement/re-injury) on treatment-related change in disability, depression, anxiety and average pain. Analyses involved generalized estimating equation models for clinical outcomes that adjusted for co-occurring change in psychological variables. This was paired with cross-lagged analysis to assess for evidence of causality. Analyses involved two time points, pre-treatment and post-treatment. Changes in pain-acceptance were strongly associated with changes in three (depression, anxiety and average pain) of the four clinical outcomes. Changes in self-efficacy were also strongly associated with two (anxiety and average pain) clinical outcomes. These findings suggest that participants were unlikely to improve in these clinical outcomes without also experiencing increases in their pain self-efficacy and pain acceptance. However, there was no clear evidence from cross-lagged analyses to currently support these psychological variables as direct mechanisms of clinical improvements. There was only statistical evidence to suggest higher levels of self-efficacy moderated improvements in depression. The findings suggest that, while clinical improvements are closely associated with improvements in pain acceptance and self-efficacy, these psychological variables may not drive the treatment effects observed. This study employed robust statistical techniques to assess the psychological mechanisms of an established internet-delivered pain management program. While clinical improvements (e.g. depression, anxiety, pain) were closely associated with improvements in psychological variables (e.g. pain self-efficacy and pain acceptance), these variables do not appear to be treatment mechanisms. © 2018 European Pain Federation - EFIC®.

Upper Gastrointestinal Hemorrhage: Development of the Severity Score.

PubMed

Chaikitamnuaychok, Rangson; Patumanond, Jayanton

2012-12-01

Emergency endoscopy for every patient with upper gastrointestinal hemorrhage is not possible in many medical centers. Simple guidelines to select patients for emergency endoscopy are lacking. The aim of the present report is to develop a simple scoring system to classify upper gastrointestinal hemorrhage (UGIH) severity based on patient clinical profiles at the emergency departments. Retrospective data of patients with UGIH in a university affiliated hospital were analyzed. Patients were criterion-classified into 3 severity levels: mild, moderate and severe. Clinical and laboratory information were compared among the 3 groups. Significant parameters were selected as indicators of severity. Coefficients of significant multivariable parameters were transformed into item scores, which added up as individual severity scores. The scores were used to classify patients into 3 urgency levels: non-urgent, urgent and emergent groups. Score-classification and criterion-classification were compared. Significant parameters in the model were age ≥ 60 years, pulse rate ≥ 100/min, systolic blood pressure < 100 mmHg, hemoglobin < 10 g/dL, blood urea nitrogen ≥ 35 mg/dL, presence of cirrhosis and hepatic failure. The score ranged from 0 to 27, and classifying patients into 3 urgency groups: non-urgent (score < 4, n = 215, 21.2%), urgent (score 4 - 16, n = 677, 66.9%) and emergent (score > 16, n = 121, 11.9%). The score correctly classified 81.4% of the patients into their original (criterion-classified) severity groups. Under-estimation (7.5%) and over-estimation (11.1%) were clinically acceptable. Our UGIH severity scoring system classified patients into 3 urgency groups: non-urgent, urgent and emergent, with clinically acceptable small number of under- and over-estimations. Its discriminative ability and precision should be validated before adopting into clinical practice.

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.

HIV Pre-Exposure Prophylaxis Interest among Female Sex Workers in Guangxi, China

PubMed Central

Zou, Yunfeng; Yang, Xiaobo; Abdullah, Abu S.; Zhong, Xiaoni; Ruan, Yuhua; Lin, Xinqin; Li, Mingqiang; Wu, Deren; Jiang, Junjun; Xie, Peiyan; Huang, Jiegang; Liang, Bingyu; Zhou, Bo; Su, Jinming; Liang, Hao; Huang, Ailong

2014-01-01

Objectives Acceptability of pre-exposure prophylaxis (PrEP) and willingness to participate in a clinical trial for both safety and efficacy of PrEP were investigated among female sex workers (FSWs) in Guangxi, China. Methods A cross-sectional study was performed in three cities in Guangxi. Structured, self-administered questionnaires were used to assess the acceptability of PrEP and the willingness to participate in a clinical trial. Multivariable logistic regression models were fitted to identify predictors. Results Among 405 participants, 15.1% had heard of PrEP. If PrEP was deemed to be effective, safe and provided for free, 85.9% reported that they would accept it, and 54.3% of those who accepted PrEP said that they would participate in a clinical trial. The increased acceptability of PrEP was associated with working in male dominated venues, higher income, a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, not being forced to use condoms by the gatekeepers, consistent use of condoms, and use of drugs to prevent STD infection. The increased willingness to participate in a clinical trial was associated with a poor family relationship, better HIV/AIDS knowledge, not realizing HIV risk from unfamiliar clients, a willingness to adhere to daily PreP use, and not being concerned about discrimination by others. The main reason for rejecting PrEP or participating in a clinical trial was the concern about the side effects of PrEP. Conclusions Acceptability of PrEP among Guangxi FSWs is relatively high, indicating that PrEP intervention programs may be feasible for Chinese FSWs. Given the fact that most of the participants had never heard of PrEP before, and that family, gatekeepers, and social discrimination could significantly affect its acceptability, a comprehensive mix of multiple interventions is necessary for the successful implementation of a PrEP program among this population in Guangxi. PMID:24465956

The clinical utility of lung clearance index in early cystic fibrosis lung disease is not impacted by the number of multiple-breath washout trials

PubMed Central

Foong, Rachel E.; Harper, Alana J.; King, Louise; Turkovic, Lidija; Davis, Miriam; Clem, Charles C.; Davis, Stephanie D.; Ranganathan, Sarath; Hall, Graham L.

2018-01-01

The lung clearance index (LCI) from the multiple-breath washout (MBW) test is a promising surveillance tool for pre-school children with cystic fibrosis (CF). Current guidelines for MBW testing recommend that three acceptable trials are required. However, success rates to achieve these criteria are low in children aged <7 years and feasibility may improve with modified pre-school criteria that accepts tests with two acceptable trials. This study aimed to determine if relationships between LCI and clinical outcomes of CF lung disease differ when only two acceptable MBW trials are assessed. Healthy children and children with CF aged 3–6 years were recruited for MBW testing. Children with CF also underwent bronchoalveolar lavage fluid collection and a chest computed tomography scan. MBW feasibility increased from 46% to 75% when tests with two trials were deemed acceptable compared with tests where three acceptable trials were required. Relationships between MBW outcomes and markers of pulmonary inflammation, infection and structural lung disease were not different between tests with three acceptable trials compared with tests with two acceptable trials. This study indicates that pre-school MBW data from two acceptable trials may provide sufficient information on ventilation distribution if three acceptable trials are not possible. PMID:29707562

Reliability, factor structure, and validity of the German version of the Trauma Symptom Checklist for Children in a sample of adolescents

PubMed Central

Matulis, Simone; Loos, Laura; Langguth, Nadine; Schreiber, Franziska; Gutermann, Jana; Gawrilow, Caterina; Steil, Regina

2015-01-01

Background The Trauma Symptom Checklist for Children (TSC-C) is the most widely used self-report scale to assess trauma-related symptoms in children and adolescents on six clinical scales. The purpose of the present study was to develop a German version of the TSC-C and to investigate its psychometric properties, such as factor structure, reliability, and validity, in a sample of German adolescents. Method A normative sample of N=583 and a clinical sample of N=41 adolescents with a history of physical or sexual abuse aged between 13 and 21 years participated in the study. Results The Confirmatory Factor Analysis on the six-factor model (anger, anxiety, depression, dissociation, posttraumatic stress, and sexual concerns with the subdimensions preoccupation and distress) revealed acceptable to good fit statistics in the normative sample. One item had to be excluded from the German version of the TSC-C because the factor loading was too low. All clinical scales presented acceptable to good reliability, with Cronbach's α's ranging from .80 to .86 in the normative sample and from .72 to .87 in the clinical sample. Concurrent validity was also demonstrated by the high correlations between the TSC-C scales and instruments measuring similar psychopathology. TSC-C scores reliably differentiated between adolescents with trauma history and those without trauma history, indicating discriminative validity. Conclusions In conclusion, the German version of the TSC-C is a reliable and valid instrument for assessing trauma-related symptoms on six different scales in adolescents aged between 13 and 21 years. PMID:26498182

Reliability, factor structure, and validity of the German version of the Trauma Symptom Checklist for Children in a sample of adolescents.

PubMed

Matulis, Simone; Loos, Laura; Langguth, Nadine; Schreiber, Franziska; Gutermann, Jana; Gawrilow, Caterina; Steil, Regina

2015-01-01

The Trauma Symptom Checklist for Children (TSC-C) is the most widely used self-report scale to assess trauma-related symptoms in children and adolescents on six clinical scales. The purpose of the present study was to develop a German version of the TSC-C and to investigate its psychometric properties, such as factor structure, reliability, and validity, in a sample of German adolescents. A normative sample of N=583 and a clinical sample of N=41 adolescents with a history of physical or sexual abuse aged between 13 and 21 years participated in the study. The Confirmatory Factor Analysis on the six-factor model (anger, anxiety, depression, dissociation, posttraumatic stress, and sexual concerns with the subdimensions preoccupation and distress) revealed acceptable to good fit statistics in the normative sample. One item had to be excluded from the German version of the TSC-C because the factor loading was too low. All clinical scales presented acceptable to good reliability, with Cronbach's α's ranging from .80 to .86 in the normative sample and from .72 to .87 in the clinical sample. Concurrent validity was also demonstrated by the high correlations between the TSC-C scales and instruments measuring similar psychopathology. TSC-C scores reliably differentiated between adolescents with trauma history and those without trauma history, indicating discriminative validity. In conclusion, the German version of the TSC-C is a reliable and valid instrument for assessing trauma-related symptoms on six different scales in adolescents aged between 13 and 21 years.

Hospital-based transfusion error tracking from 2005 to 2010: identifying the key errors threatening patient transfusion safety.

PubMed

Maskens, Carolyn; Downie, Helen; Wendt, Alison; Lima, Ana; Merkley, Lisa; Lin, Yulia; Callum, Jeannie

2014-01-01

This report provides a comprehensive analysis of transfusion errors occurring at a large teaching hospital and aims to determine key errors that are threatening transfusion safety, despite implementation of safety measures. Errors were prospectively identified from 2005 to 2010. Error data were coded on a secure online database called the Transfusion Error Surveillance System. Errors were defined as any deviation from established standard operating procedures. Errors were identified by clinical and laboratory staff. Denominator data for volume of activity were used to calculate rates. A total of 15,134 errors were reported with a median number of 215 errors per month (range, 85-334). Overall, 9083 (60%) errors occurred on the transfusion service and 6051 (40%) on the clinical services. In total, 23 errors resulted in patient harm: 21 of these errors occurred on the clinical services and two in the transfusion service. Of the 23 harm events, 21 involved inappropriate use of blood. Errors with no harm were 657 times more common than events that caused harm. The most common high-severity clinical errors were sample labeling (37.5%) and inappropriate ordering of blood (28.8%). The most common high-severity error in the transfusion service was sample accepted despite not meeting acceptance criteria (18.3%). The cost of product and component loss due to errors was $593,337. Errors occurred at every point in the transfusion process, with the greatest potential risk of patient harm resulting from inappropriate ordering of blood products and errors in sample labeling. © 2013 American Association of Blood Banks (CME).

Adaptive clinical trial designs for European marketing authorization: a survey of scientific advice letters from the European Medicines Agency.

PubMed

Elsäßer, Amelie; Regnstrom, Jan; Vetter, Thorsten; Koenig, Franz; Hemmings, Robert James; Greco, Martina; Papaluca-Amati, Marisa; Posch, Martin

2014-10-02

Since the first methodological publications on adaptive study design approaches in the 1990s, the application of these approaches in drug development has raised increasing interest among academia, industry and regulators. The European Medicines Agency (EMA) as well as the Food and Drug Administration (FDA) have published guidance documents addressing the potentials and limitations of adaptive designs in the regulatory context. Since there is limited experience in the implementation and interpretation of adaptive clinical trials, early interaction with regulators is recommended. The EMA offers such interactions through scientific advice and protocol assistance procedures. We performed a text search of scientific advice letters issued between 1 January 2007 and 8 May 2012 that contained relevant key terms. Letters containing questions related to adaptive clinical trials in phases II or III were selected for further analysis. From the selected letters, important characteristics of the proposed design and its context in the drug development program, as well as the responses of the Committee for Human Medicinal Products (CHMP)/Scientific Advice Working Party (SAWP), were extracted and categorized. For 41 more recent procedures (1 January 2009 to 8 May 2012), additional details of the trial design and the CHMP/SAWP responses were assessed. In addition, case studies are presented as examples. Over a range of 5½ years, 59 scientific advices were identified that address adaptive study designs in phase II and phase III clinical trials. Almost all were proposed as confirmatory phase III or phase II/III studies. The most frequently proposed adaptation was sample size reassessment, followed by dropping of treatment arms and population enrichment. While 12 (20%) of the 59 proposals for an adaptive clinical trial were not accepted, the great majority of proposals were accepted (15, 25%) or conditionally accepted (32, 54%). In the more recent 41 procedures, the most frequent concerns raised by CHMP/SAWP were insufficient justifications of the adaptation strategy, type I error rate control and bias. For the majority of proposed adaptive clinical trials, an overall positive opinion was given albeit with critical comments. Type I error rate control, bias and the justification of the design are common issues raised by the CHMP/SAWP.

Computerized symptom and quality-of-life assessment for patients with cancer part II: acceptability and usability.

PubMed

Mullen, Kristin H; Berry, Donna L; Zierler, Brenda K

2004-09-01

To determine the acceptability and usability of a computerized quality-of-life (QOL) and symptom assessment tool and the graphically displayed QOL and symptom output in an ambulatory radiation oncology clinic. Descriptive, cross-sectional. Radiation oncology clinic located in an urban university medical center. 45 patients with cancer being evaluated for radiation therapy and 10 clinicians, who submitted 12 surveys. Acceptability of the computerized assessment was measured with an online, 16-item, Likert-style survey delivered as 45 patients undergoing radiation therapy completed a 25-item QOL and symptom assessment. Usability of the graphic output was assessed with clinician completion of a four-item paper survey. Acceptability and usability of computerized patient assessment. The patient acceptability survey indicated that 70% (n = 28) liked computers and 10% (n = 4) did not. The program was easy to use for 79% (n = 26), easy to understand for 91% (n = 30), and enjoyable for 71% (n = 24). Seventy-six percent (n = 25) believed that the amount of time needed to complete the computerized survey was acceptable. Sixty-six percent (n = 21) responded that they were satisfied with the program, and none of the participants chose the very dissatisfied response. Eighty-three percent (n = 10) of the clinicians found the graphic output helpful in promoting communication with patients, 75% (n = 9) found the output report helpful in identifying appropriate areas of QOL deficits or concerns, and 83% (n = 10) indicated that the output helped guide clinical interactions with patients. The computer-based QOL and symptom assessment tool is acceptable to patients, and the graphically displayed QOL and symptom output is useful to radiation oncology nurses and physicians. Wider application of computerized patient-generated data can continue in various cancer settings and be tested for clinical and organizational outcomes.

Excimer laser for the treatment of psoriasis: safety, efficacy, and patient acceptability

PubMed Central

Abrouk, Michael; Levin, Ethan; Brodsky, Merrick; Gandy, Jessica R; Nakamura, Mio; Zhu, Tian Hao; Farahnik, Benjamin; Koo, John; Bhutani, Tina

2016-01-01

Introduction The 308 nm excimer laser is a widely used device throughout the field of dermatology for many diseases including psoriasis. Although the laser has demonstrated clinical efficacy, there is a lack of literature outlining the safety, efficacy, and patient acceptability of the excimer laser. Methods A literature search on PubMed was used with combinations of the terms “excimer”, “excimer laser”, “308 nm”, “psoriasis”, “protocol”, “safety”, “efficacy”, acceptability”, “side effects”, and “dose”. The search results were included if they contained information pertaining to excimer laser and psoriasis treatment and description of the safety, efficacy, and patient acceptability of the treatment. Results The 308 nm excimer laser is generally safe and well tolerated with minimal side effects including erythema, blistering, and pigmentary changes. It has a range of efficacies depending on the protocol used with several different treatment protocols, including the induration protocol, the minimal erythema dose protocol, and the newer minimal blistering dose protocol. Conclusion Although the excimer laser is not a first-line treatment, it remains an excellent treatment option for psoriasis patients and has been demonstrated to be an effective treatment with little to no side effects. PMID:29387603

Cost-effectiveness acceptability curves and a reluctance to lose.

PubMed

Severens, Johan L; Brunenberg, Daniëlle E M; Fenwick, Elisabeth A L; O'Brien, Bernie; Joore, Manuela A

2005-01-01

Cost-effectiveness acceptability curves (CEACs) are a method used to present uncertainty surrounding incremental cost-effectiveness ratios (ICERs). Construction of the curves relies on the assumption that the willingness to pay (WTP) for health gain is identical to the willingness to accept (WTA) health loss. The objective of this paper is to explore the impact that differences between WTP and WTA health changes have on CEACs. Previous empirical evidence has shown that the relationship between WTP and WTA is not 1:1. The discrepancy between WTP and WTA for health changes can be expressed as a ratio: the accept/reject ratio (which can vary between 1 and infinity). Depending on this ratio, the area within the southwest quadrant of the cost-effectiveness plane in which any bootstrap cost-effect pairs will be considered to be cost effective will be smaller, resulting in a lower CEAC. We used data from two clinical trials to illustrate that relaxing the 1:1 WTP/WTA assumption has an impact on the CEACs. Given the difficulty in assessing the accept/reject ratio for every evaluation, we suggest presenting a series of CEACs for a range of values for the accept/reject ratio, including 1 and infinite. Although it is not possible to explain this phenomenon within the extra-welfarist framework, it has been shown empirically that individuals give a higher valuation to the removal of effective therapies than to the introduction of new therapies that are more costly and effective. In cost-effectiveness analyses where uncertainty of the ICER covers the southwest quadrant of the cost-effectiveness plane, the discrepancy between societies' WTP and WTA should be indicated by drawing multiple CEACs.

Driver acceptance of collision warning applications based on heavy-truck V2V technology

DOT National Transportation Integrated Search

2016-10-01

Battelle conducted a series of driver acceptance clinics (DACs) with heavy-truck drivers to gauge their acceptance of collision-warning applications using vehicle-to-vehicle (V2V) communication technology. This report describes the results from Volpe...

Construct validity and internal consistency reliability of the Malay version of the 21-item depression anxiety stress scale (Malay-DASS-21) among male outpatient clinic attendees in Johor.

PubMed

Rusli, B N; Amrina, K; Trived, S; Loh, K P; Shashi, M

2017-10-01

The 21-item English version of the Depression Anxiety Stress Scale (DASS-21) has been proposed as a method for assessing self-perceived depression, anxiety and stress over the past week in various clinical and nonclinical populations. Several Malay versions of the DASS-21 have been validated in various populations with varying success. One particular Malay version has been validated in various occupational groups (such as nurses and automotive workers) but not among male clinic outpatient attendees in Malaysia. To validate the Malay version of the DASS-21 (Malay-DASS-21) among male outpatient clinic attendees in Johor. A validation study with a random sample of 402 male respondents attending the outpatient clinic of a major public outpatient clinic in Johor Bahru and Segamat was carried out from January to March 2016. Construct validity of the Malay-DASS-21 was examined using Exploratory Factor Analysis (KMO = 0.947; Bartlett's test of sphericity is significant, p<0.001) through Principal Component Analysis and orthogonal (varimax) rotation with Kaiser Normalization to confirm the psychometric properties of the Malay-DASS- 21 and the internal consistency reliability using Cronbach's alpha. Construct validity of the Malay-DASS-21 based on eigenvalues and factor loadings to confirm the three factor structure (depression, anxiety, and stress) was acceptable. The internal consistency reliability of the factor construct was very impressive with Cronbach's alpha values in the range of 0.837 to 0.863. The present study showed that the Malay- DASS-21 has acceptable psychometric construct and high internal consistency reliability to measure self-perceived depression, anxiety and stress over the past week in male outpatient clinic attendees in Johor. Further studies are necessary to revalidate the Malay-DASS-21 across different populations and cultures, and using confirmatory factor analyses.

Inter-examiner classification reliability of Mechanical Diagnosis and Therapy for extremity problems - Systematic review.

PubMed

Takasaki, Hiroshi; Okuyama, Kousuke; Rosedale, Richard

2017-02-01

Mechanical Diagnosis and Therapy (MDT) is used in the treatment of extremity problems. Classifying clinical problems is one method of providing effective treatment to a target population. Classification reliability is a key factor to determine the precise clinical problem and to direct an appropriate intervention. To explore inter-examiner reliability of the MDT classification for extremity problems in three reliability designs: 1) vignette reliability using surveys with patient vignettes, 2) concurrent reliability, where multiple assessors decide a classification by observing someone's assessment, 3) successive reliability, where multiple assessors independently assess the same patient at different times. Systematic review with data synthesis in a quantitative format. Agreement of MDT subgroups was examined using the Kappa value, with the operational definition of acceptable reliability set at ≥ 0.6. The level of evidence was determined considering the methodological quality of the studies. Six studies were included and all studies met the criteria for high quality. Kappa values for the vignette reliability design (five studies) were ≥ 0.7. There was data from two cohorts in one study for the concurrent reliability design and the Kappa values ranged from 0.45 to 1.0. Kappa values for the successive reliability design (data from three cohorts in one study) were < 0.6. The current review found strong evidence of acceptable inter-examiner reliability of MDT classification for extremity problems in the vignette reliability design, limited evidence of acceptable reliability in the concurrent reliability design and unacceptable reliability in the successive reliability design. Copyright © 2017 Elsevier Ltd. All rights reserved.

Variability amongst radiographers in the categorization of clinical acceptability for digital trauma radiography

NASA Astrophysics Data System (ADS)

Decoster, Robin; Toomey, Rachel; Smits, Dirk; Mol, Harrie; Verhelle, Filip; Butler, Marie-Louise

2016-03-01

Introduction: Radiographers evaluate anatomical structures to judge clinical acceptability of a radiograph. Whether a radiograph is deemed acceptable for diagnosis or not depends on the individual decision of the radiographer. Individual decisions cause variation in the accepted image quality. To minimise these variations definitions of acceptability, such as in RadLex, were developed. On which criteria radiographers attribute a RadLex categories to radiographs is unknown. Insight into these criteria helps to further optimise definitions and reduce variability in acceptance between radiographers. Therefore, this work aims the evaluation of the correlation between the RadLex classification and the evaluation of anatomical structures, using a Visual Grading Analysis (VGA) Methods: Four radiographers evaluated the visibility of five anatomical structures of 25 lateral cervical spine radiographs on a secondary class display with a VGA. They judged clinical acceptability of each radiograph using RadLex. Relations between VGAS and RadLex category were analysed with Kendall's Tau correlation and Nagelkerke pseudo-R². Results: The overall VGA score (VGAS) and the RadLex score correlate (rτ= 0.62, p<0.01, R2=0.72) strongly. The observers' evaluation of contrast between bone, air (trachea) and soft tissue has low value in predicting (rτ=0.55, p<0.01, R2=0.03) the RadLex score. The reproduction of spinous processes (rτ=0.67, p<0.01, R2=0.31) and the evaluation of the exposure (rτ=0.65, p<0.01, R2=0.56) have a strong correlation with high predictive value for the RadLex score. Conclusion: RadLex scores and VGAS correlate positively, strongly and significantly. The predictive value of bony structures may support the use of these in the judgement of clinical acceptability. Considerable inter-observer variations in the VGAS within a certain RadLex category, suggest that observers use of observer specific cut-off values.

Tablet splitting: a review of the clinical and economic outcomes and patient acceptance. Second of a 2-part series. Part 1 was published in May 2012 (Consult Pharm 2012;27:239-53).

PubMed

Freeman, Maisha Kelly; White, Whitney; Iranikhah, Maryam

2012-06-01

To describe the clinical outcomes, patient acceptance, and economic effect associated with tablet splitting. PubMed (1966-June 2011) and International Pharmaceutical Abstract (1975-June 2011) searches were conducted using tablet splitting as the search terms. All studies that evaluated the clinical outcome (n = 4), patient acceptance (n = 5), and economic effects (n = 8) of tablet splitting were included. The American Pharmacists Association guidelines, recommendations from the Food and Drug Administration, and clinical trial data were evaluated. The majority of trials conducted evaluating clinical outcomes associated with tablet splitting were evaluated in patients receiving statins and antihypertensives. Clinical outcomes associated with risperidone were assessed. No adverse clinical outcomes were observed with therapy. Most studies evaluating the economic effects of tablet splitting have revealed a cost savings associated with this process; however, many studies were subject to limitations. The first part of this two-part series reviewed the weight and content uniformity in tablet splitting. Tablet splitting does not seem to significantly affect clinical outcomes related to management of hypertension, cholesterol, or psychiatric disorders, nor influence overall patient adherence.

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

PubMed

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

2010-02-01

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

Factors associated with acceptance of provider-initiated HIV testing and counseling among pregnant women in Ethiopia.

PubMed

Gebremedhin, Ketema Bizuwork; Tian, Bingjie; Tang, Chulei; Zhang, Xiaoxia; Yisma, Engida; Wang, Honghong

2018-01-01

The global human immunodeficiency virus (HIV) epidemic disproportionately affects sub-Saharan African countries, including Ethiopia. Provider-initiated HIV testing and counseling (PITC) is a tool to identify HIV-positive pregnant women and an effective treatment and prevention strategy. However, its success depends upon the willingness of pregnant women to accept HIV testing. To describe the level of acceptance of PITC and associated factors among pregnant women attending 8 antenatal care clinics in Adama, Ethiopia. Trained nursing students and employees from an HIV clinic conducted face-to-face structured interviews in private offices at the clinics from August to September, 2016. Among the 441 respondents, 309 (70.1%) accepted PITC. Women with more antenatal care visits (odds ratio [OR] =2.59, 95% CI: 1.01-6.63), reported better quality of the PITC service (OR =1.91, 95% CI: 1.19-3.08), and higher level of knowledge on mother-to-child transmission (OR =1.82, 95% CI: 1.03-3.20), were more likely to accept PITC, while women who were older in age (OR =0.37, 95% CI: 0.19-0.74) and perceived negative attitudes from their partners toward HIV-positive results (OR =0.31, 95% CI: 0.10-0.94) were less likely to accept the PITC service. About one-third of pregnant women are not willing to accept PITC. When designing intervention program to improve the acceptance of PITC, we should take into consideration the personal factors, HIV-related knowledge, and attitude of women as well as institutional factors.

A pilot study on the functional performance and acceptability of an innovative female condom (Wondaleaf®) in Malaysia.

PubMed

Ting, Rachel Sing-Kiat; Wong, Ee-Lynn; Tnay, Jessie Koh-Sing

2018-01-01

Female condom (FC) has been available for over 30 years, but it still lacks wide acceptability. To overcome misdirection and invagination occurring in FC and to provide a wider area of protection, Wondaleaf ® (WL), a new-generation adhesive FC, was recently invented. This pioneering study sought to assess the acceptability and functional performance of WL among Malaysian women. A mixed method survey was conducted in three cities of Malaysia, recruiting sexually active heterosexual women, aged 18-50, by snowball sampling method. Participants were provided with WL and initially surveyed to rate its performance in five coital usages over 2 months. After that, the participants underwent a second survey to rate their satisfaction and acceptability toward WL. Descriptive statistics on clinical failure rates were tabulated with correlational analysis performed to identify major variables contributing to WL's functional performance and acceptability. Out of the 51 enrolled participants, 31 women completed the required surveys. WL's total clinical failure rate was 2.60% (out of 155 condom uses) with above-average ratings of functional performance. The ease of use significantly correlated with ratings of no slippage and no misdirection. The confidence in WL's safety features significantly correlated with a sense of empowerment and protection. WL has a relatively low risk of clinical failures and an overall favorable acceptability among Malaysian women. However, this study also showed that its future usage largely depends on partner acceptability. It may have the potential of complementing the existing barrier toward contraceptive use. Further studies are needed to understand the global acceptability of WL.

Analytical performance of three whole blood point-of-care lactate devices compared to plasma lactate comparison methods and a flow-injection mass spectrometry method.

PubMed

Tolan, Nicole V; Wockenfus, Amy M; Koch, Christopher D; Crews, Bridgit O; Dietzen, Dennis J; Karon, Brad S

2017-03-01

Point of care (POC) whole blood lactate testing may facilitate rapid detection of sepsis. We evaluated three POC methods against both plasma lactate comparison methods and a flow-injection mass spectrometric (MS) method. Nova StatStrip, Abbott i-STAT CG4+ and Radiometer ABL90 POC lactate methods were evaluated against the mean of Cobas Integra 400 and Vitros 350 plasma lactate. POC methods were also compared to a flow-injection mass spectrometric assay measuring lactate in ZnSO 4 -precipitated whole blood extracts. Intra- and inter-assay precision was determined using quality control material. Method comparison included specimens from normal donors at rest, after exertion, and after spiking with lactic acid. Intra- and inter-assay coefficient of variation was <5% for i-STAT and ABL90; but ranged from 3.1-8.2% on two StatStrip meters. Mean (±SD) bias between POC and plasma lactate ranged from -0.2±0.9 (i-STAT and ABL90) to -0.4±1.2 (StatStrip) mmol/L. At concentrations >6mmol/L, all POC methods showed proportional negative bias compared to plasma methods; but this bias was not observed when compared to the MS method. Despite proportional negative bias, all POC methods demonstrated acceptable concordance (94-100%) with plasma lactate within the reference interval (<2.3mmol/L) and >4mmol/L, commonly used clinical cut-offs for detection of sepsis. POC lactate methods demonstrate acceptable concordance with plasma lactate across commonly used clinical cut-offs for detection of sepsis. Due to systematic negative bias at higher lactate concentrations, POC and plasma lactate should not be used interchangeably to monitor patients with elevated lactate concentrations. Copyright © 2016 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Aftermath of Ankle Inversion Injuries: Spectrum of MR Imaging Findings.

PubMed

Meehan, Timothy M; Martinez-Salazar, Edgar Leonardo; Torriani, Martin

2017-02-01

Acute and chronic ankle inversion injuries are a common source of pain and a diagnostic challenge. Several studies have shown a variety of injury patterns after inversion injury both in acute and chronic settings. Although traditional assessment with clinical examination and radiographs is generally accepted for inversion injuries, MR imaging is a useful tool to detect occult injuries and in patients with chronic symptoms. This article examines a range of MR imaging findings that may be present in patients with lateral ankle pain following an acute or chronic inversion injury. Copyright © 2016 Elsevier Inc. All rights reserved.

Ultrasonic Blood Flow Measurement in Haemodialysis

PubMed Central

Sampson, D.; Papadimitriou, M.; Kulatilake, A. E.

1970-01-01

A 5-megacycle Doppler flow meter, calibrated in-vitro, was found to give a linear response to blood flow in the ranges commonly encountered in haemodialysis. With this, blood flow through artificial kidneys could be measured simply and with a clinically acceptable error. The method is safe, as blood lines do not have to be punctured or disconnected and hence there is no risk of introducing infection. Besides its value as a research tool the flow meter is useful in evaluating new artificial kidneys. Suitably modified it could form the basis of an arterial flow alarm system. PMID:5416812

Stenting of the cervical internal carotid artery in acute stroke management: The Karolinska experience.

PubMed

Mpotsaris, Anastasios; Kabbasch, Christoph; Borggrefe, Jan; Gontu, Vamsi; Soderman, Michael

2017-04-01

Background Emergency stent placement in the extracranial internal carotid artery in combination with anterior circulation thrombectomy is a routine procedure. Yet, precise indications and clinical safety in this setting remains controversial. Present data for mechanical thrombectomy include few studies with acute stenting of tandem occlusions. We evaluated the feasibility, safety and clinical outcome of this endovascular treatment in a retrospective analysis of all consecutive cases at a comprehensive stroke centre. Methods This was a retrospective analysis of all consecutive patients with acute extracranial carotid artery occlusion including acute dissection or high-grade stenosis and concomitant intracranial large-vessel occlusion treated with emergency carotid stenting and intracranial mechanical thrombectomy between November 2007 and May 2015. Results A total of 63 patients with a median age of 67 years (range 33-84 years) were treated. Of these, 33 (52%) patients had concomitant intravenous thrombolysis with recombinant tissue-type plasminogen activator initially. Median admission National Institutes of Health Stroke Scale was 14 (range 1-29). Median time from stroke onset to recanalization was 408 minutes (range 165-1846 minutes). Procedure time was significantly shorter after intravenous thrombolysis (110 minutes [range 15-202 minutes] vs. 130 minutes [range 60-280 minutes]; p = 0.02). Three (5%) patients experienced post-procedural symptomatic intracerebral haemorrhage. In 55/63 (87%) patients, a score of ≥2b on the Thrombolysis in Cerebral Infarction scale could be achieved. Eight (13%) patients died, five (8%) during the acute phase. A total of 29/63 (46%) patients showed a favourable outcome (modified Rankin Scale score of 0-2) after three months. Conclusions Our single-centre retrospective analysis of emergency stent placement in the extracranial internal carotid artery in combination with anterior circulation thrombectomy demonstrated high technical success, reasonable clinical outcomes and acceptable rates of symptomatic intracranial haemorrhage in carefully chosen patients which are triaged interdisciplinary based on clinical and computed tomography imaging criteria. This warrants further study in a randomised prospective trial.

Pharmacokinetic bioequivalence, safety and acceptability of Ornibel®, a new polymer composition contraceptive vaginal ring (etonogestrel/ethinylestradiol 11.00/3.474 mg) compared with Nuvaring® (etonogestrel/ethinylestradiol 11.7/2.7 mg).

PubMed

Algorta, Jaime; Diaz, Maria; de Benito, Raquel; Lefebvre, Marc; Sicard, Eric; Furtado, Milton; Regidor, Pedro Antonio; Ronchi, Celestino

2017-12-01

To show the clinical development of Ornibel ® (ExeltisHealthcare, Spain) a contraceptive vaginal ring manufactured with a new polymer composition and containing etonogestrel/ethinylestradiol, compared to Nuvaring ® (MSD, Spain). Randomised, single dose, 2-period, 2-sequence, 2-stage crossover, comparative bioavailability study conducted in 40 healthy female subjects. All subjects received both treatments for 28 days in each of two periods, separated by a 28 days washout. Ornibel ® contains etonogestrel/ethinylestradiol 11.00/3.47 mg and Nuvaring ® contains etonogestrel/ethinylestradiol 11.7/2.7 mg, both rings delivering 120/15 µg/day. For the calculation of pharmacokinetic parameters, 37 blood samples were collected up to 840 h after each ring insertion to quantify plasma concentrations of etonogestrel and ethinylestradiol using a validated MS/MS-HPLC. Safety was assessed by adverse events recording, clinical laboratory and vital signs and tolerability by vaginal examination. Acceptability was investigated by a 5-point scale questionnaire. Bioequivalence was demonstrated in the first stage as the 94.12% Confidence Intervals of the primary parameters laid within the 80-125% acceptance range for both etonogestrel (C max : 96.81-112.20%; AUC 0-504h : 98.71-108.61%; AUC 0-t : 100.14-109.10%) and ethinylestradiol. (C max : 105.91-120.62%; AUC 0-504h : 105.47-114.59%; AUC 0-t : 108.31-117.61%). During the first day of use a burst effect was observed with Nuvaring ® , with significantly higher level of ethinylestradiol (C max0-24h ratio: 78.34%, 94.12CI: 73.55-83.45%). Both products were well tolerated and accepted, without significant differences between them. Ornibel ® is bioequivalent to Nuvaring ® in terms of efficacy, safety, tolerability and acceptability. The new polymer composition provides Ornibel ® with more stability and gradual hormonal release during the first day of use, particularly for ethinylestradiol.

Don’t forget the posters! Quality and content variables associated with accepted abstracts at a national trauma meeting

PubMed Central

Dossett, Lesly A.; Fox, Erin E.; del Junco, Deborah J.; Zaydfudim, Victor; Kauffmann, Rondi; Shelton, Julia; Wang, Weiwei; Cioffi, William G.; Holcomb, John B.; Cotton, Bryan A.

2014-01-01

BACKGROUND As a primary venue for presenting research results, abstracts selected for presentation at national meetings should be of the highest scientific merit and research quality. It is uncertain to what degree this is achieved as the methodological quality of abstracts submitted to national surgical meetings has not been previously described. The objective of this study was to evaluate abstracts presented at a leading trauma meeting for methodological quality. METHODS All abstracts accepted for the 2009 American Association for the Surgery of Trauma meeting were reviewed and scored for methodological quality based on 10 criteria (scores, 0–10; 10 being the highest). Criteria were based on nationally published methodology guidelines. Two independent reviewers who were blinded to institution, region, and author reviewed each abstract. RESULTS A total of 187 abstracts were accepted for presentation (67 oral and 120 posters). The most frequent clinical topics were shock/transfusion (23%), abdomen (12%), and nervous system (11%). Shock/transfusion abstracts were more common in the oral presentations (31% vs. 19%; p =0.06). Abstracts from the northeast and south regions were the most common in both oral (26% and 29%) and posters (25% and 24%). Basic science accounted for 12% of accepted studies, while 51% were clinical and 28% were health services/outcomes. Only 8% of abstracts presented randomized data and only 11% reported null findings. Overall abstract scores ranged from 3 to 10 (median, 7; mean, 7.4). Abstracts selected for poster presentation had an overall higher score than those selected for oral presentation (7.4 ±1.7 vs. 6.8 ±1.7; p =0.02). CONCLUSION Although oral presentations traditionally receive the most attention and interest, the methodological quality of abstracts accepted for poster presentation equals (and sometimes exceeds) that of oral abstracts. Attendees of these national meetings should reconsider their time spent in viewing and visiting these poster sessions as with the oral presentations. In light of our findings, we highly encourage that all members and guests attend the American Association for the Surgery of Trauma Poster Rounds at each year’s scientific assembly. PMID:22673278

Don't forget the posters! Quality and content variables associated with accepted abstracts at a national trauma meeting.

PubMed

Dossett, Lesly A; Fox, Erin E; del Junco, Deborah J; Zaydfudim, Victor; Kauffmann, Rondi; Shelton, Julia; Wang, Weiwei; Cioffi, William G; Holcomb, John B; Cotton, Bryan A

2012-05-01

As a primary venue for presenting research results, abstracts selected for presentation at national meetings should be of the highest scientific merit and research quality. It is uncertain to what degree this is achieved as the methodological quality of abstracts submitted to national surgical meetings has not been previously described. The objective of this study was to evaluate abstracts presented at a leading trauma meeting for methodological quality. All abstracts accepted for the 2009 American Association for the Surgery of Trauma meeting were reviewed and scored for methodological quality based on 10 criteria (scores, 0-10; 10 being the highest). Criteria were based on nationally published methodology guidelines. Two independent reviewers who were blinded to institution, region, and author reviewed each abstract. A total of 187 abstracts were accepted for presentation (67 oral and 120 posters). The most frequent clinical topics were shock/transfusion (23%), abdomen (12%), and nervous system (11%). Shock/transfusion abstracts were more common in the oral presentations (31% vs. 19%; p = 0.06). Abstracts from the northeast and south regions were the most common in both oral (26% and 29%) and posters (25% and 24%). Basic science accounted for 12% of accepted studies, while 51% were clinical and 28% were health services/outcomes. Only 8% of abstracts presented randomized data and only 11% reported null findings. Overall abstract scores ranged from 3 to 10 (median, 7; mean, 7.4). Abstracts selected for poster presentation had an overall higher score than those selected for oral presentation (7.4 ± 1.7 vs. 6.8 ± 1.7; p = 0.02). Although oral presentations traditionally receive the most attention and interest, the methodological quality of abstracts accepted for poster presentation equals (and sometimes exceeds) that of oral abstracts. Attendees of these national meetings should reconsider their time spent in viewing and visiting these poster sessions as with the oral presentations. In light of our findings, we highly encourage that all members and guests attend the American Association for the Surgery of Trauma Poster Rounds at each year's scientific assembly.

Acceptability of an Electronic Self Report Assessment Program for Patients with Cancer

PubMed Central

Wolpin, S.; Berry, D.; Austin-Seymour, M.; Bush, N.; Fann, J.R.; Halpenny, B.; Lober, W.; McCorkle, Ruth

2010-01-01

Background Eliciting symptom and quality of life information from patients is an important component of medical and nursing care processes. Traditionally, this information has been collected with paper and pencil. However, this approach presents several barriers, including delays in receiving information, difficulty integrating responses with electronic records and the time required to manual score questionnaires for measurement purposes. One solution that addresses many of these barriers is the adoption of computerized screening for symptom and quality of life information. Objective This research explored the acceptability of asking symptom and quality of life questions using the Electronic Self Report Assessment – Cancer program on wireless laptops equipped with touch screen format. Methods Acceptability data was explored with respect to whether any differences may be attributed to demographics, and symptom and quality of life levels such as depression, cognitive and emotional functioning. This evaluation utilized descriptive and univariate statistics to examine data from 342 participants from the ongoing ESRA-C randomized clinical trial. Research participants for the ESRA-C study were recruited from the Seattle Cancer Care Alliance (SCCA), a consortium between the University of Washington Medical Center, Fred Hutchinson Cancer Research Center, and Children’s Hospital and Regional Medical Center in Seattle, Washington. Results The sample consisted of 342 adult participants who completed both baseline and follow-up survey sessions. Medical Oncology represented the largest recruitment group (45.3%), followed by Stem Cell Transplant (34.5%) and Radiation Oncology (20.2%). The primary finding was that patients were generally able to utilize ESRA-C quickly and without difficulty in a real-world clinical setting and that they were overall quite satisfied with the ESRA-C program. Significant differences were found in several acceptability areas with respect to demographics and quality of life measures, such as age, gender, and severe distress. Conclusions This analysis confirms that the ESRA-C application for collecting symptom and quality of life information is easy for patients to use and acceptable across a range of user characteristics. We intend to build on our work by using the survey platform in other modalities while ensuring that the patient’s preferences are considered at all times. PMID:19047882

Acceptability of an Electronic Self-Report Assessment Program for patients with cancer.

PubMed

Wolpin, Seth; Berry, Donna; Austin-Seymour, Mary; Bush, Nigel; Fann, Jesse R; Halpenny, Barbara; Lober, William B; McCorkle, Ruth

2008-01-01

Eliciting symptom and quality of life information from patients is an important component of medical and nursing care processes. Traditionally, this information has been collected with paper and pencil. However, this approach presents several barriers, including delays in receiving information, difficulty in integrating responses with electronic records, and the time required to manually score questionnaires for measurement purposes. One solution that addresses many of these barriers is the adoption of computerized screening for symptom and quality-of-life information. This research explored the acceptability of asking symptom and quality-of-life questions using the Electronic Self Report Assessment-Cancer program on wireless laptops equipped with touch-screen format. Acceptability data were explored with respect to whether any differences may be attributed to demographics and symptom and quality-of-life levels, such as depression and cognitive and emotional functioning. This evaluation used descriptive and univariate statistics to examine data from 342 participants from the ongoing ESRA-C randomized clinical trial. Research participants for the ESRA-C study were recruited from the Seattle Cancer Care Alliance, a consortium among the University of Washington Medical Center, Fred Hutchinson Cancer Research Center, and Children's Hospital and Regional Medical Center in Seattle, WA. The sample consisted of 342 adult participants who completed both baseline and follow-up survey sessions. Medical oncology represented the largest recruitment group (45.3%), followed by stem cell transplant (34.5%) and radiation oncology (20.2%). The primary finding was that patients were generally able to use ESRA-C quickly and without difficulty in a real-world clinical setting and that they were overall quite satisfied with the ESRA-C program. Significant differences were found in several acceptability areas with respect to demographics and quality of life measures such as age, sex, and severe distress. This analysis confirms that the ESRA-C application for collecting symptom and quality of life information is easy for patients to use and acceptable across a range of user characteristics. We intend to build on our work by using the survey platform in other modalities while ensuring that the patient's preferences are considered at all times.

[Psychometric properties of the Hungarian version of the Cognitive Emotion Regulation Questionnaire].

PubMed

Miklósi, Mónika; Martos, Tamás; Kocsis-Bogár, Krisztina; Perczel Forintos, Dóra

2011-01-01

The Cognitive Emotion Regulation Questionnaire (CERQ) measures conscious attentional and thinking processes that people often use to regulate their emotions. The English version of the CERQ - consisting of nine subscales: self-blame, rumination, catastrophizing, other blame, acceptance, positive refocusing, planning, positive reappraisal and putting into perspective - showed excellent psychometric properties in previous investigations and is widely used in current research and clinical practice. The present study describes the psychometric properties of the Hungarian version of the CERQ. The forward and back-translation method was used for the adaptation. 261 undergraduate and graduate students completed the Hungarian version of the CERQ, the Shortened Beck Depression Inventory (BDI-S), the 5-item version of the WHO Well-being Index (WBS-5) and a short demographical form. CERQ subscales showed acceptable to very good internal consistency (Cronbach's alphas ranging from 0.68 to 0.88) and strong test-retest reliability (Pearson's correlations ranging from 0.58 to 0.85, p<0.001 ). No associations were found between the emotion regulation strategies and gender and socioeconomic status. Confirmatory and exploratory factor analysis supported the theoretical model with nine independent factors. Multiple linear regression analyses revealed significant relationships between BDI-S and self-blame, acceptance, planning, positive reappraisal and catastrophizing (F=14,28 p<0,001, adjusted R2=0,320), and WBI-5 and self-blame, rumination, positive refocusing and positive reappraisal (F=5,89 p<0,001; adjusted R2=0,26). Results indicate that the Hungarian version of the CERQ is a reliable and useful instrument for assessment of cognitive emotion regulation strategies.

Discrete choice experiment produced estimates of acceptable risks of therapeutic options in cancer patients with febrile neutropenia.

PubMed

Sung, Lillian; Alibhai, Shabbir M; Ethier, Marie-Chantal; Teuffel, Oliver; Cheng, Sylvia; Fisman, David; Regier, Dean A

2012-06-01

To use a discrete choice experiment (DCE) to describe patient/proxy tolerance for the number of clinic visits, and chances of readmission, intensive care unit admission, and mortality to accept oral outpatient management of low-risk febrile neutropenia. Adults and children aged 12-18 years with cancer and parents of pediatric cancer patients were asked to choose between outpatient oral and inpatient intravenous management of low-risk febrile neutropenia. Using a DCE, we varied the attribute levels with the outpatient option and kept them constant for the inpatient option. Seventy-eight adults, 153 parents, and 43 children provided responses. All four attributes significantly affected choices. The mean tolerance (95% confidence interval) for the number of clinic visits per week was 3.6 (2.2-4.8), 2.1 (1.1-3.2), and 4.3 (2.5-6.0) to accept outpatient management among adults, parents, and children, respectively. With thrice weekly clinic visits and 7.5% chance of readmission, probabilities of accepting the outpatient strategy were 50% (44-54%) for adults, 43% (39-48%) for parents, and 53% (46-59%) for children. Using a DCE, we determined that a 7.5% chance of readmission and clinic visits more frequently than thrice weekly are unlikely to be acceptable. Copyright © 2012 Elsevier Inc. All rights reserved.

The emergence of retail-based clinics in the United States: early observations.

PubMed

Laws, Margaret; Scott, Mary Kate

2008-01-01

Retail-based clinics have proliferated rapidly in the past two years, with approximately 1,000 sites in thirty-seven states representing almost three million cumulative visits. Clinic operators have evolved from a dispersed group of privately financed concerns to a concentrated, largely corporate-owned group. A major development has been the move to large-scale acceptance of insurance, deviating from the initial cash-pay model. Consumers' acceptance and the fact that the clinics appear to increase access for both the uninsured and the insured has encouraged providers and policymakers to consider this approach to basic, acute care while seeking a better understanding of these clinics.

'Feel the Feeling': Psychological practitioners' experience of acceptance and commitment therapy well-being training in the workplace.

PubMed

Wardley, Matt Nj; Flaxman, Paul E; Willig, Carla; Gillanders, David

2016-08-01

This empirical study investigates psychological practitioners' experience of worksite training in acceptance and commitment therapy using an interpretative phenomenological analysis methodology. Semi-structured interviews were conducted with eight participants, and three themes emerged from the interpretative phenomenological analysis data analysis: influence of previous experiences, self and others and impact and application The significance of the experiential nature of the acceptance and commitment therapy training is explored as well as the dual aspects of developing participants' self-care while also considering their own clinical practice. Consistencies and inconsistencies across acceptance and commitment therapy processes are considered as well as clinical implications, study limitations and future research suggestions. © The Author(s) 2014.

[Basic principles, planning and implementation of non-commercial clinical trials].

PubMed

Finger, R P; Coch, C; Coenen, M; Mengel, M; Hartmann, G; Holz, F G

2011-01-01

The proof of a drug's efficacy in randomized controlled trials is fundamental to therapeutic concepts determined by evidence-based medicine. Clinical trials according to the German Medicinal Products Act are performed by the pharmaceutical industry as company-sponsored trials (CST) driven by commercial interests or by non-commercial facilities as investigator-initiated trials (IIT), typically implemented by University Hospitals. In areas with no commercial interest, IITs are the driving force that generate scientific progress leading to treatment optimization. Therefore, non-commercial or investigator-initiated clinical trials are indispensable for improving medical care. To ensure the safety of trial participants and the quality of the data obtained, clinical trials are controlled by many legal regulations and internationally accepted quality standards. Therefore implementation of a clinical trial requires profound knowledge, qualified personnel, appropriate infrastructure, and substantial financial resources. In IITs unlike CSTs this has to be accomplished by the University without the assistance of the pharmaceutical industry. Since teaching of skills needed to perform clinical trials is still largely neglected in medical school and during residency this review addresses the (in clinical trials) inexperienced physician and outlines the characterization of a clinical trial, the range and division of responsibilities and the performance of clinical trials according to the German Medicinal Products Act.

Are medical students accepted by patients in teaching hospitals?

PubMed Central

Marwan, Yousef; Al-Saddique, Muhammad; Hassan, Adnan; Karim, Jumanah; Al-Saleh, Mervat

2012-01-01

Background Worldwide, patients are the cornerstone of bedside teaching of medical students. In this study, the authors aimed to assess patients’ acceptability toward medical students in teaching hospitals of the Faculty of Medicine of Kuwait University. Methods Ninehundred and ninety five patients were approached in 14 teaching hospitals; 932 patients agreed to participate (refusal rate is 6.3%). A self-administered questionnaire was used to collect data. Results In general, higher acceptance of students by patients was found when there is no direct contact between the patient and the student (e.g., reading patients’ files, presenting in outpatient clinic, observing doctors performing examination or procedures) compared to other situations (e.g., performing physical examination or procedures). Pediatrics patients showed higher acceptance of students compared to patients in other specialties, while Obstetrics/Gynecology patients showed the highest refusal of students. Gender of patients (especially females) and students appeared to affect the degree of acceptance of medical students by patients. Majority of the patients (436; 46.8%) believed that the presence of medical students in hospitals improves the quality of health care. Conclusion Patients are an important factor of bedside teaching. Clinical tutors must take advantage of patients who accept medical students. Clinical tutors and medical students should master essential communication skills to convince patients in accepting students, thus improving bedside teaching. Also, using simulation and standardization should be considered to address scenarios that most patients are unwilling to allow students to participate. PMID:22509091

Quantifying the effect of air gap, depth, and range shifter thickness on TPS dosimetric accuracy in superficial PBS proton therapy.

PubMed

Shirey, Robert J; Wu, Hsinshun Terry

2018-01-01

This study quantifies the dosimetric accuracy of a commercial treatment planning system as functions of treatment depth, air gap, and range shifter thickness for superficial pencil beam scanning proton therapy treatments. The RayStation 6 pencil beam and Monte Carlo dose engines were each used to calculate the dose distributions for a single treatment plan with varying range shifter air gaps. Central axis dose values extracted from each of the calculated plans were compared to dose values measured with a calibrated PTW Markus chamber at various depths in RW3 solid water. Dose was measured at 12 depths, ranging from the surface to 5 cm, for each of the 18 different air gaps, which ranged from 0.5 to 28 cm. TPS dosimetric accuracy, defined as the ratio of calculated dose relative to the measured dose, was plotted as functions of depth and air gap for the pencil beam and Monte Carlo dose algorithms. The accuracy of the TPS pencil beam dose algorithm was found to be clinically unacceptable at depths shallower than 3 cm with air gaps wider than 10 cm, and increased range shifter thickness only added to the dosimetric inaccuracy of the pencil beam algorithm. Each configuration calculated with Monte Carlo was determined to be clinically acceptable. Further comparisons of the Monte Carlo dose algorithm to the measured spread-out Bragg Peaks of multiple fields used during machine commissioning verified the dosimetric accuracy of Monte Carlo in a variety of beam energies and field sizes. Discrepancies between measured and TPS calculated dose values can mainly be attributed to the ability (or lack thereof) of the TPS pencil beam dose algorithm to properly model secondary proton scatter generated in the range shifter. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Pattern of parental acceptance of management techniques used in pediatric dentistry.

PubMed

Peretz, Benjamin; Kharouba, Johnny; Blumer, Sigalit

2013-01-01

To evaluate parents' acceptance of management techniques in Israeli pediatric dental clinics. Ninety parents who accompanied their children to three pediatric dental clinics provided information on selected parameters including their attitudes about management techniques. 68.9% of the parents preferred to stay in the treatment room. The most accepted technique was positive reinforcement (81.1%) followed by tell-show-do (TSD) (76.7%, with younger parents more accepting than older, p = 0.049). The least accepted techniques were restraint (1.1%) and voice control (7.8%, especially by parents with the highest dental anxiety, p = 0.002). Sedation was unacceptable by 15.6% of the parents: those with the lowest dental anxiety agreed to sedation significantly more than those with greater dental anxiety (p = 0.031). Parents preferred more positive approaches and management techniques that involve demonstrations geared for the child's level of understanding. Restraint and voice control were more strongly rejected than sedation.

Development of a clinical definition for acute respiratory distress syndrome using the Delphi technique.

PubMed

Ferguson, Niall D; Davis, Aileen M; Slutsky, Arthur S; Stewart, Thomas E

2005-06-01

The objective of this study is to describe the implementation of formal consensus techniques in the development of a clinical definition for acute respiratory distress syndrome. A Delphi consensus process was conducted using e-mail. Sixteen panelists who were both researchers and opinion leaders were systematically recruited. The Delphi technique was performed over 4 rounds on the background of an explicit definition framework. Item generation was performed in round 1, item reduction in rounds 2 and 3, and definition evaluation in round 4. Explicit consensus thresholds were used throughout. Of the 16 panelists, 11 actually participated in developing a definition that met a priori consensus rules on the third iteration. New incorporations in the Delphi definition include the use of a standardized oxygenation assessment and the documentation of either a predisposing factor or decreased thoracic compliance. The panelists rated the Delphi definition as acceptable to highly acceptable (median score, 6; range, 5-7 on a 7-point Likert scale). We conclude that it is feasible to consider using formal consensus in the development of future definitions of acute respiratory distress syndrome. Testing of sensibility, reliability, and validity are needed for this preliminary definition; these test results should be incorporated into future iterations of this definition.

Porcelain surface conditioning protocols and shear bond strength of orthodontic brackets.

PubMed

Lestrade, Ashley M; Ballard, Richard W; Xu, Xiaoming; Yu, Qingzhao; Kee, Edwin L; Armbruster, Paul C

2016-05-01

The objective of the present study was to determine which of six bonding protocols yielded a clinically acceptable shear bond strength (SBS) of metal orthodontic brackets to CAD/CAM lithium disilicate porcelain restorations. A secondary aim was to determine which bonding protocol produced the least surface damage at debond. Sixty lithium disilicate samples were fabricated to replicate the facial surface of a mandibular first molar using a CEREC CAD/CAM machine. The samples were split into six test groups, each of which received different mechanical/chemical pretreatment protocols to roughen the porcelain surface prior to bonding a molar orthodontic attachment. Shear bond strength testing was conducted using an Instron machine. The mean, maximum, minimal, and standard deviation SBS values for each sample group including an enamel control were calculated. A t-test was used to evaluate the statistical significance between the groups. No significant differences were found in SBS values, with the exception of surface roughening with a green stone prior to HFA and silane treatment. This protocol yielded slightly higher bond strength which was statistically significant. Chemical treatment alone with HFA/silane yielded SBS values within an acceptable clinical range to withstand forces applied by orthodontic treatment and potentially eliminates the need to mechanically roughen the ceramic surface.

Barriers and Solutions to Fieldwork Education in Hand Therapy.

PubMed

Short, Nathan; Sample, Shelby; Murphy, Malachi; Austin, Brittany; Glass, Jillian

2017-08-09

Survey. Fieldwork education is a vital component of training the next generation of CHTs. Barriers and solutions to fieldwork rotations in hand therapy are examined, as well as proposed solutions, including recommendations for student preparation. This descriptive study examined barriers for certified hand therapist clinicians to accept students for clinical rotations and clinicians' preferences for student preparation before a rotation in a hand setting. A survey was developed, peer reviewed, and distributed using the electronic mailing list of the Hand Therapy Certification Commission via SurveyMonkey. Aggregate responses were analyzed to identify trends including barriers to student clinical rotations and recommendations for students to prepare for hand rotations. A total of 2080 participants responded to the survey, representing a 37% response rate. Common logistical barriers were identified for accepting students such as limited clinical time and space. Many clinicians (32% agree and 8% strongly agree) also felt that the students lack the clinical knowledge to be successful. Areas of knowledge, skill set, and experience were surveyed for development before a clinical rotation in a hand setting. Most respondents (74%) reported increased likelihood of accepting a student with the recommended preparation. Novel qualitative responses to improve clinical experiences are presented as well. Student preparation before a clinical rotation in a hand setting appears to be a significant barrier based on the survey results. Areas of recommended knowledge, skill set, and experience may serve to guide both formal and informal methods of student preparation before a hand-specific clinical rotation to facilitate knowledge translation from experienced certified hand therapists to the next generation. Although logistical barriers may be difficult to overcome, hand-specific preparation based on clinician' recommendations may facilitate student acceptance and success in hand specialty clinical rotations. N/A. Copyright © 2017 Hanley & Belfus. Published by Elsevier Inc. All rights reserved.

Arthroscopic-assisted Locking Compression Plate clavicular hook fixation for unstable fractures of the lateral end of the clavicle: a prospective study

PubMed Central

Lee, Kwang Won; Kim, Kap Jung; Kim, Yong In; Kwon, Won Cho; Choy, Won Sik

2009-01-01

The aim of this prospective study was to assess the clinical outcomes of an unstable fracture of the lateral end of the clavicle treated with an arthroscopic-assisted locking compressive plate (LCP) clavicular hook plate. Twenty-three patients underwent arthroscopic assisted LCP clavicular hook plate fixation for these fractures. All patients achieved clinical and radiological union over a mean of 4.2 months (range, 3.4–5 months). Four patients (17%) showed some degree of acromial osteolysis. Three patients (13%) showed radiological signs of arthrosis of the acromioclavicular joint. In one patient, a second fracture (stress) was observed between the medial two screws of the plate without an additional injury. Five patients (22%) showed subacromial bursitis on dynamic ultrasonography. The mean Constant and Murley score was 91 points (range, 81–98). The average level of pain in the shoulder at rest and on abduction was 1 (range, 0–2) and 2.4 (range, 0–4), respectively. Based on our experience, arthroscopic-assisted LCP hook plate fixation for the treatment of unstable fractures of the lateral end of the clavicle is not without complications. However, it is an acceptable alternative method that is easy to apply with good results. Furthermore, it prevents rotator cuff impingement, allows early mobilisation and maintains the acromioclavicular joint biomechanics. PMID:19998033

Genetic testing for the risk of developing late effects among survivors of childhood cancer: Consumer understanding, acceptance, and willingness to pay.

PubMed

Georgiou, Gabrielle; Wakefield, Claire E; McGill, Brittany C; Fardell, Joanna E; Signorelli, Christina; Hanlon, Lucy; Tucker, Kathy; Patenaude, Andrea F; Cohn, Richard J

2016-09-15

Genetic testing to determine cancer survivors' risk of developing late effects from their cancer treatment will be increasingly used in survivorship care. This 2-stage study with 64 survivors of childhood cancer and their parents investigated the preferences and acceptability of testing among those who may be at risk of developing late effects. The first stage (Stage 1) identified the most commonly perceived benefits and concerns regarding genetic testing for the risk of late effects among 24 participants. In Stage 2, during interviews, 20 survivors (55% of whom were female; mean age, 26.0 years [range, 18-39 years]; standard deviation [SD], 0.80) and 20 parents (55% of whom were male; mean age of child survivor, 14.2 years [range, 10-19 years]; SD, 0.79) rated the 7 most common benefits and concerns from those identified in Stage 1. Interviews were transcribed verbatim and analyzed. Decisional balance ratios were calculated by dividing the participants' average concerns scores with the average benefits scores. Genetic testing for late effects was highly acceptable: 95% of participants leaned toward testing, and the majority (65.9%) would pay up to Australian $5000. The majority (97.2%) reported it was acceptable to wait for up to 6 months to receive results, and to be offered testing immediately after treatment or when the survivor reached adulthood (62.9%). Survivors and parents had a highly positive decisional balance (Mean (M), 0.5 [SD, 0.38] and M, 0.5 [SD, 0.39], respectively), indicating that perceived benefits outweighed concerns. Although to our knowledge clinical efficacy has yet to be clearly demonstrated, survivors and parents described positive interest in genetic testing for the risk of developing late effects. Perceived benefits outweighed harms, and the majority of participants would be willing to pay, and wait, for testing. Cancer 2016. © 2016 American Cancer Society. Cancer 2016;122:2876-2885. © 2016 American Cancer Society. © 2016 American Cancer Society.

Assessing the Social Acceptability of the Functional Analysis of Problem Behavior

ERIC Educational Resources Information Center

Langthorne, Paul; McGill, Peter

2011-01-01

Although the clinical utility of the functional analysis is well established, its social acceptability has received minimal attention. The current study assessed the social acceptability of functional analysis procedures among 10 parents and 3 teachers of children who had recently received functional analyses. Participants completed a 9-item…

Effectiveness of functional electrical stimulation on walking speed, functional walking category, and clinically meaningful changes for people with multiple sclerosis.

PubMed

Street, Tamsyn; Taylor, Paul; Swain, Ian

2015-04-01

To determine the effectiveness of functional electrical stimulation (FES) on drop foot in patients with multiple sclerosis (MS), using data from standard clinical practice. Case series with a consecutive sample of FES users collected between 2008 and 2013. Specialist FES center at a district general hospital. Patients with MS who have drop foot (N=187) (117 women, 70 men; mean age, 55y [range, 27-80y]; mean duration since diagnosis, 11.7y [range, 1-56y]). A total of 166 patients were still using FES after 20 weeks, with 153 patients completing the follow-up measures. FES of the common peroneal nerve (178 unilateral, 9 bilateral FES users). Clinically meaningful changes (ie, >.05m/s and >0.1m/s) and functional walking category derived from 10-m walking speed. An increase in walking speed was found to be highly significant (P<.001), both initially where a minimum clinically meaningful change was observed (.07m/s) and after 20 weeks with a substantial clinically meaningful change (.11m/s). After 20 weeks, treatment responders displayed a 27% average improvement in their walking speed. No significant training effect was found. Overall functional walking category was maintained or improved in 95% of treatment responders. FES of the dorsiflexors is a well-accepted intervention that enables clinically meaningful changes in walking speed, leading to a preserved or an increased functional walking category. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Psychometric Analysis of the Barber Suggestibility Scale in a Clinical Population.

PubMed

Pellicer Asensio, Xavier; Fusté Escolano, Adela; Ruiz Rodríguez, José

2018-04-01

The aim of the study was to administer the Barber suggestibility scale to a clinical population in Spain and to examine its psychometric properties therein. The reliability and factor structure of the adapted scale was compared with that of the original (American) scale and with data from two other versions (British and Puerto Rican samples). Sex differences in suggestibility were also analyzed. The Barber suggestibility scale was administered (without preliminaries) to a sample of 283 patients (130 women, 153 men) with a range of diagnoses: anxiety disorder (33.9%), substance-related and addictive disorder (25.8%), mood disorder (12.7%), somatic symptom disorder (4.6%), trauma- and stress-related disorder (3.5%), and other disorders (19.5%). Results indicated a higher degree of suggestibility among women, with the effect size being low (d = 0.26) for the objective subscale and moderate (d = 0.55) for the subjective subscale. Therefore, normative scores were reported by sex for both subscales. As a whole, the present clinical sample showed higher suggestibility than has been reported previously for nonclinical populations (p < 0.001; d = 1.56). Reliability indices (Cronbach's alpha and split-half/Spearman-Brown) for the present adaptation in a clinical population indicated acceptable internal consistency (range 0.70-0.82). Applied to a clinical sample the Barber suggestibility scale showed a three-factor structure for the objective subscale and a more complex structure for the subjective subscale. These results suggest that the Barber suggestibility scale is a suitable instrument for assessing the degree of suggestibility in persons with a clinical disorder.

Ethical pitfalls in neonatal comparative effectiveness trials.

PubMed

Modi, Neena

2014-01-01

Evidence-based medicine has been embraced wholeheartedly, and rightly so, as the best approach for reducing clinical uncertainty and ensuring that patients receive treatment and care that are efficacious (i.e. they work) and effective (i.e. they work in real life). High-quality evidence comes from high-quality clinical research. It would hence be reasonable to assume that these two would form a closely integrated partnership. Alas, this is not yet the case. So many uncertainties in medical care relate to treatments and practices already widely in use. In neonatal medicine, for example, some of us use protein-carbohydrate fortification of human milk and some of us do not, some of us stop enteral feeds during blood transfusions whereas some of us do not, some of us reach for dopamine when blood pressure falls while some of us use dobutamine. For our patients, these uncertainties represent a lottery, the throw of the dice that determines whether they receive the treatment advocated by Dr. A or Dr. B. They deserve better than this. Randomization is considered the gold standard approach to eliminating the clinician bias that very often dominates the choice of treatments. Randomization reduces the influence on outcomes of confounding by unknown factors, and ensures that every patient has a fair and equal chance of receiving the best possible treatment when this is, in fact, not known. In an ideal world, every medical uncertainty would be addressed in this way. The evaluation of treatments that are in accepted use has been termed 'comparative effectiveness research', i.e. the comparison of existing healthcare interventions to determine which works best, for whom and under which circumstances. Recently a long-standing uncertainty, the optimum saturation target for preterm babies receiving oxygen was put to the test of randomization. The accepted standard-of-care saturation range of 85-95% has been used for a considerable time and its use is intended to avoid both levels of oxygen that are too low or too high. Investigators in the UK, Australia, New Zealand and the USA designed randomized controlled trials to provide more precise guidance, by determining whether targeting the lower end of the accepted range (85-89%) resulted in reduced retinopathy of prematurity when compared with the upper end of the accepted range (91-95%). Between 2004 and 2009, the US SUPPORT trial (Surfactant, Positive Pressure and Oxygenation Randomized Trial) recruited approximately 1,300 infants and showed that babies at the higher end of the recommended oxygen saturation range had a greater incidence of retinopathy of prematurity, but that, unexpectedly, babies at the lower end had a higher risk of death [1]. The data monitoring committees of the BOOST II (Oxygen Saturation and Outcomes in Preterm Infants) trials in the UK, Australia and New Zealand reviewed their interim data, confirmed the higher risk of death in babies randomized to the lower saturation range, and halted further recruitment [2]. Without the trials, the lower saturation target would have continued to be applied to many babies, and many would have died as a result. Though many uncertainties remain, the trials facilitated advances in care. However, in March 2013, the lead investigators for the SUPPORT trial were informed by the US 'Office for Human Research Protections' that they were 'in violation of the regulatory requirements for informed consent, stemming from the failure to describe the reasonably foreseeable risks of blindness, neurological damage and death' [3]. This extraordinary conclusion indicates that the US regulators considered the researchers to be at fault for failing to foresee an unexpected trial result, and for randomizing babies to receive oxygen within the accepted standard-of-care limits. The ruling further implies that the regulators consider that clinicians are acting ethically when they deliver an accepted but non-evidence-based treatment based upon their personal bias, but are acting unethically when they make the selection by randomization. Clearly, there is a gulf between the view of the medical profession and that of the regulators regarding the ethical and scientific validity of randomization as a means to select treatments in comparative effectiveness research aimed at reducing uncertainties in care. What are the ways forward? I suggest that, in order for medicine to advance, a paradigm shift is necessary, involving a deeper public (and regulator) understanding of randomization as the fairest approach to allocating treatments that are in wide and accepted use, but where the evidence base is actually uncertain, so that the chance of receiving the as yet unknown best treatment is unaffected by clinician bias, and where care is delivered along a clearly designed, closely monitored pathway. In practice, peer review, regulatory approval, patient involvement and the delivery of explanation and information would be the same as for research involving experimental treatments. The key difference would be that randomization would be the recommended default and patients would be offered the opportunity to opt out, rather than be invited to opt in. For neonatal medicine, this would reduce the risk of 'injurious misconception', where trial entry is inappropriately rejected by parents because of an exaggerated and disproportionate perception of risk [4] that is brought on or magnified by the burden of making decisions at this difficult and stressful time. Randomization to treatments that fall within accepted practice and are considered standard-of-care involves no research-related risks to participants, and as trial data can increasingly be extracted from electronic clinical records [5], the costs and burden of data collection placed upon clinical teams will be minimized and, ultimately, the resolution of uncertainties about treatment can be hastened. It should also be noted that this approach fulfils the four cardinal principles of research ethics, namely: autonomy, justice, beneficence and nonmaleficence as well as upholding the responsibility of all doctors to strive to reduce uncertainty in the care they provide to their patients [6].

To what extent do clinical notes by general practitioners reflect actual medical performance? A study using simulated patients.

PubMed Central

Rethans, J J; Martin, E; Metsemakers, J

1994-01-01

BACKGROUND. Review of clinical notes is used extensively as an indirect method of assessing doctors' performance. However, to be acceptable it must be valid. AIM. This study set out to examine the extent to which clinical notes in medical records of general practice consultations reflected doctors' actual performance during consultations. METHOD. Thirty nine general practitioners in the Netherlands were consulted by four simulated patients who were indistinguishable from real patients and who reported on the consultations. The complaints presented by the simulated patients were tension headache, acute diarrhoea and pain in the shoulder, and one presented for a check up for non-insulin dependent diabetes. Later, the doctors forwarded their medical records of these patients to the researchers. Content of consultations was measured against accepted standards for general practice and then compared with content of clinical notes. An index, or content score, was calculated as the measure of agreement between actions which had actually been recorded and actions which could have been recorded in the clinical notes. A high content score reflected a consultation which had been recorded well in the medical record. The correlation between number of actions across the four complaints recorded in the clinical notes and number of actions taken during the consultations was also calculated. RESULTS. The mean content score (interquartile range) for the four types of complaint was 0.32 (0.27-0.37), indicating that of all actions undertaken, only 32% had been recorded. However, mean content scores for the categories 'medication and therapy' and 'laboratory examination' were much higher than for the categories 'history' and 'guidance and advice' (0.68 and 0.64, respectively versus 0.29 and 0.22, respectively). The correlation between number of actions across the four complaints recorded in the clinical notes and number of actions taken during the consultations was 0.54 (P < 0.05). CONCLUSION. The use of clinical notes to audit doctors' performance in Dutch general practice is invalid. However, the use of clinical notes to rank doctors according to those who perform many or a few actions in a consultation may be justified. PMID:8185988

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results.

PubMed

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero; Alongi, Filippo

2017-06-01

To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Weekly cisplatin and volumetric-modulated arc therapy-simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated.

Weekly Cisplatin and Volumetric-Modulated Arc Therapy With Simultaneous Integrated Boost for Radical Treatment of Advanced Cervical Cancer in Elderly Patients: Feasibility and Clinical Preliminary Results

PubMed Central

Mazzola, Rosario; Ricchetti, Francesco; Fiorentino, Alba; Levra, Niccolò Giaj; Fersino, Sergio; Di Paola, Gioacchino; Ruggieri, Ruggero

2016-01-01

Background: To evaluate the feasibility and clinical preliminary results of weekly cisplatin and volumetric-modulated arc therapy to the pelvis with simultaneous integrated boost to macroscopic disease in a cohort of elderly patients. Materials and Methods: Inclusion criteria of this prospective study were age ≥70 years, Karnofsky performance status 70 to 100, locally advanced histologically proven squamous cervical carcinoma, and patients unable to undergo brachytherapy. Radiation doses prescribed were 66 Gy to the macroscopic disease and 54 Gy to the pelvic nodes in 30 fractions. Weekly cisplatin dose was 40 mg/mq. Results: A total of 30 patients were recruited. Median follow-up was 32 months (range: 8-48 months). Median age was 72 years (range: 70-84 years). The 3-year overall survival and local control were 93% and 80%, respectively. The median time to progression was 24 months (range: 6-30 months). Analyzing clinical outcome grouping based on the stage of disease, II versus III, the 3-year overall survival was 100% and 85%, respectively. The 3-year local control was 91% for stage II and 67% for stage III. Acute and late toxicities were acceptable without severe events. Conclusion: Weekly cisplatin and volumetric-modulated arc therapy–simultaneous integrated boost for radical treatment of advanced cervical cancer in the current cohort of elderly patients were feasible. Long-term results and prospective randomized trials are advocated. PMID:27402633

Knowledge and Acceptability of Human Papillomavirus Vaccination among Women Attending the Gynaecological Outpatient Clinics of a University Teaching Hospital in Lagos, Nigeria.

PubMed

Okunade, Kehinde S; Sunmonu, Oyebola; Osanyin, Gbemisola E; Oluwole, Ayodeji A

2017-01-01

This study was aimed at determining the knowledge and acceptability of HPV vaccine among women attending the gynaecology clinics of the Lagos University Teaching Hospital (LUTH). This was a descriptive cross-sectional study involving 148 consecutively selected women attending the gynaecology clinic of LUTH. Relevant information was obtained from these women using an interviewer-administered questionnaire. The data was analysed and then presented by simple descriptive statistics using tables and charts. Chi-square statistics were used to test the association between the sociodemographical variables and acceptance of HPV vaccination. All significance values were reported at P < 0.05. The mean age of the respondents was 35.7 ± 9.7 years. The study showed that 36.5% of the respondents had heard about HPV infection while only 18.9% had knowledge about the existence of HPV vaccines. Overall, 81.8% of the respondents accepted that the vaccines could be administered to their teenage girls with the level of education of the mothers being the major determinant of their acceptability ( P = 0.013). Awareness of HPV infections and existence of HPV vaccines is low. However, the acceptance of HPV vaccines is generally high. Efforts should be made to increase the awareness about cervical cancer, its aetiologies, and prevention via HPV vaccination.

A pilot study on the functional performance and acceptability of an innovative female condom (Wondaleaf®) in Malaysia

PubMed Central

Wong, Ee-Lynn; Tnay, Jessie Koh-Sing

2018-01-01

Background Female condom (FC) has been available for over 30 years, but it still lacks wide acceptability. To overcome misdirection and invagination occurring in FC and to provide a wider area of protection, Wondaleaf® (WL), a new-generation adhesive FC, was recently invented. This pioneering study sought to assess the acceptability and functional performance of WL among Malaysian women. Methods A mixed method survey was conducted in three cities of Malaysia, recruiting sexually active heterosexual women, aged 18–50, by snowball sampling method. Participants were provided with WL and initially surveyed to rate its performance in five coital usages over 2 months. After that, the participants underwent a second survey to rate their satisfaction and acceptability toward WL. Descriptive statistics on clinical failure rates were tabulated with correlational analysis performed to identify major variables contributing to WL’s functional performance and acceptability. Results Out of the 51 enrolled participants, 31 women completed the required surveys. WL’s total clinical failure rate was 2.60% (out of 155 condom uses) with above-average ratings of functional performance. The ease of use significantly correlated with ratings of no slippage and no misdirection. The confidence in WL’s safety features significantly correlated with a sense of empowerment and protection. Conclusion WL has a relatively low risk of clinical failures and an overall favorable acceptability among Malaysian women. However, this study also showed that its future usage largely depends on partner acceptability. It may have the potential of complementing the existing barrier toward contraceptive use. Further studies are needed to understand the global acceptability of WL. PMID:29440937

Weight loss expectations and body dissatisfaction in young women attempting to lose weight.

PubMed

Siervo, M; Montagnese, C; Muscariello, E; Evans, E; Stephan, B C M; Nasti, G; Papa, A; Iannetti, E; Colantuoni, A

2014-04-01

Unrealistic weight loss expectations (WLEs) and greater body dissatisfaction may be associated with the poor long-term outcomes of dietary and lifestyle weight loss treatments. We evaluated the association between body size, WLEs and body dissatisfaction in young women attempting to lose weight. Forty-four young healthy women [age range 18-35 years, body mass index (BMI) range 23-40 kg/m2] were recruited. Women were classified as obese (BMI ≥ 30.0 kg/m2) and non-obese (BMI <30.0 kg/m2). The Body Dissatisfaction scale of the Eating Disorder Inventory-2 and the Body Image Assessment for Obesity silhouette charts were used to assess body dissatisfaction. WLEs were categorised according to personal (ideal, happiness, satisfaction, weight history), lifestyle (fitness) and social (career, family acceptance, peer acceptance, mass media, social pressure) factors. Individual WLEs were compared with recommended clinical targets (5%, 10% and 20%) for weight loss. Body dissatisfaction was lower in non-obese subjects and was directly associated with BMI (P < 0.05). WLEs were directly associated with BMI and the obese group reported greater expectations. Five non-obese subjects (23%) desired to lose more than 20% of their body weight, whereas the proportion was significantly higher in the obese group (17 subjects; 74%). Subjects derived the greatest WLEs from mass media, whereas they perceived that family and friends were supportive of a lesser degree of weight loss. We observed a mismatch between clinical and personal expectations, and social pressure and interpersonal relationships appear to have a prominent role with respect to influencing the association. © 2013 The Authors Journal of Human Nutrition and Dietetics © 2013 The British Dietetic Association Ltd.

[Transcatheter closure of atrial septal defects in 40 pediatric patients].

PubMed

Deng, Dong-an; Zhu, Xian-yang; Hou, Chuan-ju; Han, Xiu-min; Wang, Qi-guang; Jin, Yan; Quan, Wei; Liu, Yang; Wang, Shu-fan

2003-07-01

To evaluate the clinical efficiency of transcatheter closure of atrial septal defect (ASD) with AGA-Amplatzer occlusion device in pediatric patients. Forty patients with ASD, 16 males, 24 females, at a mean age of 10.2 years (ranged from 3 to 15 years of age) and with a mean weight of 35.8 kg (ranged from 11 to 87 kg) were studied. Six cases were complicated with pulmonary stenosis (PS), 1 was complicated with ventricular tachycardia (VT). Right heart catheterizations were done in 40 patients for measuring the pressures of right ventricle and pulmonary artery. The balloon diameter of ASD was measured using balloon catheter with guiding wire. The diameter of ASD was measured by TTE and/or TEE, ascertaining the location and size of ASD. Amplatzer occlusion device was sized to be equal to or 1 - 2 mm more than the diameter of balloon stretched. All patients had successful implantation of the Amplatzer device. The success rate was 100%. The diameter measured by TTE was 7 - 30 mm (mean 17.12 mm). The diameter measured by TEE was 7 - 32 mm (mean 18.44 mm). The diameter of balloon stretched of ASD was 8 - 34 mm. Of the 40 cases, 6 were complicated with PS and accepted percutaneous balloon valvuloplasty (PBPV). One case was complicated with VT and accepted radiofrequency catheter ablation (RFCA). Neither complication nor residual shunt was found in any of the patients. The patients were recovered and followed up for 3 or 4 days after deployment of the Amplatzer device. Clinical symptom, cardiac murmur, and findings in ECG, echocardiography and X-ray were improved markedly. AGA-Amplatzer occlusion device is safe and efficient in pediatric patients with ASD.

Carbon Nanostructures in Bone Tissue Engineering

PubMed Central

Perkins, Brian Lee; Naderi, Naghmeh

2016-01-01

Background: Recent advances in developing biocompatible materials for treating bone loss or defects have dramatically changed clinicians’ reconstructive armory. Current clinically available reconstructive options have certain advantages, but also several drawbacks that prevent them from gaining universal acceptance. A wide range of synthetic and natural biomaterials is being used to develop tissue-engineered bone. Many of these materials are currently in the clinical trial stage. Methods: A selective literature review was performed for carbon nanostructure composites in bone tissue engineering. Results: Incorporation of carbon nanostructures significantly improves the mechanical properties of various biomaterials to mimic that of natural bone. Recently, carbon-modified biomaterials for bone tissue engineering have been extensively investigated to potentially revolutionize biomaterials for bone regeneration. Conclusion: This review summarizes the chemical and biophysical properties of carbon nanostructures and discusses their functionality in bone tissue regeneration. PMID:28217212

Integration of Hospital Information and Clinical Decision Support Systems to Enable the Reuse of Electronic Health Record Data.

PubMed

Kopanitsa, Georgy

2017-05-18

The efficiency and acceptance of clinical decision support systems (CDSS) can increase if they reuse medical data captured during health care delivery. High heterogeneity of the existing legacy data formats has become the main barrier for the reuse of data. Thus, we need to apply data modeling mechanisms that provide standardization, transformation, accumulation and querying medical data to allow its reuse. In this paper, we focus on the interoperability issues of the hospital information systems (HIS) and CDSS data integration. Our study is based on the approach proposed by Marcos et al. where archetypes are used as a standardized mechanism for the interaction of a CDSS with an electronic health record (EHR). We build an integration tool to enable CDSSs collect data from various institutions without a need for modifications in the implementation. The approach implies development of a conceptual level as a set of archetypes representing concepts required by a CDSS. Treatment case data from Regional Clinical Hospital in Tomsk, Russia was extracted, transformed and loaded to the archetype database of a clinical decision support system. Test records' normalization has been performed by defining transformation and aggregation rules between the EHR data and the archetypes. These mapping rules were used to automatically generate openEHR compliant data. After the transformation, archetype data instances were loaded into the CDSS archetype based data storage. The performance times showed acceptable performance for the extraction stage with a mean of 17.428 s per year (3436 case records). The transformation times were also acceptable with 136.954 s per year (0.039 s per one instance). The accuracy evaluation showed the correctness and applicability of the method for the wide range of HISes. These operations were performed without interrupting the HIS workflow to prevent the HISes from disturbing the service provision to the users. The project results have proven that archetype based technologies are mature enough to be applied in routine operations that require extraction, transformation, loading and querying medical data from heterogeneous EHR systems. Inference models in clinical research and CDSS can benefit from this by defining queries to a valid data set with known structure and constraints. The standard based nature of the archetype approach allows an easy integration of CDSSs with existing EHR systems.

Transition of Care in Adolescents With Cerebral Palsy: A Survey of Current Practices.

PubMed

Bolger, Ashlee; Vargus-Adams, Jilda; McMahon, Mary

2017-03-01

Transition of care from pediatric to adult health care providers for youth with special needs (including cerebral palsy [CP]) is of current interest because these individuals are now living well into adulthood. Studies have attempted to identify barriers to transition, ideal timing for transition of care, and key elements for successful transition programs. These studies often encompass a wide range of diagnoses, and results cannot be fully applied to those with CP. To identify and describe current transition-of-care (TOC) practices and beliefs among physician providers of adolescents with CP in multidisciplinary CP clinics. Descriptive survey. Multidisciplinary CP clinics in the United States. Physician leaders in the aforementioned CP clinics. Respondents completed an electronic survey. Responses were deidentified and reported in aggregate by the use of descriptive statistics. Electronic survey addressing 3 domains: demographics of clinics, current opinions/practices related to TOC processes, and perceived barriers to successful TOC. Fifteen surveys were sent with 11 returned (response rate = 73%). TOC practices varied among clinics surveyed. Fifty-five percent of clinics had a structured transition program, but only one transitioned 100% of their patients to adult providers by 22 years of age. Only one clinic had an absolute upper age limit for seeing patients, and 36% of clinics accepted new patients older than 21 years. No respondent was "completely satisfied" with their transition process, and only one respondent was "moderately satisfied." The majority of respondents felt the ideal care setting for adults with CP was a comprehensive, multidisciplinary adult-focused clinic in an adult hospital/clinic with primarily adult providers. They noted the top 3 perceived barriers to successful TOC were limited adult providers willing to accept CP patients, concern about the level of care in the adult health care system, and lack of financial resources. Current TOC practices vary considerably among multidisciplinary pediatric CP clinics and are not satisfactory to individual physician providers within these clinics. Respondents desired a multidisciplinary clinic in an adult care setting with adult providers; however, the top 3 perceived barriers involved the adult health care system, making it difficult for pediatric providers to develop effective TOC programs. Not applicable. Copyright © 2017 American Academy of Physical Medicine and Rehabilitation. Published by Elsevier Inc. All rights reserved.

Validation and testing of the Acceptability E-scale for Web-based patient-reported outcomes in cancer care

PubMed Central

Tariman, Joseph D.; Berry, Donna L.; Halpenny, Barbara; Wolpin, Seth; Schepp, Karen

2010-01-01

The performance of the Acceptability E-scale was tested in a sample of 627 adult and older adult patients from various oncology clinics who completed an electronic symptoms survey. The revised Acceptability E-scale has strong psychometric properties and can be useful in assessing the acceptability and usability of computerized health-related programs in oncology and other health population. PMID:20974066

Reliability of tonosafe disposable tonometer prisms: clinical implications from the Veterans Affairs Boston Healthcare System Quality Assurance Study.

PubMed

Thomas, V; Daly, M K; Cakiner-Egilmez, T; Baker, E

2011-05-01

Given the Veterans Affairs Boston Healthcare System's recent introduction of single-use Tonosafe disposable tonometer prisms as an alternative to Goldmann applanation tonometers (GATs), this study had two aims: to conduct a large-scale quality assurance trial to assess the reliability of intraocular pressure (IOP) measurements of the Tonosafe disposable tonometer compared with GAT, particularly at extremes of pressure; to evaluate the suitability of Tonosafe disposable tonometer prisms as an acceptable substitute for GATs and for clinic-wide implementation in an academic tertiary referral setting. Ophthalmology resident physicians measured the IOPs of patients in general and specialty eye clinics with the Tonosafe disposable tonometer and GAT. Tonosafe test-retest reliability data were also collected. A retrospective review of patient charts and data analysis were performed to determine the reliability of measurements. The IOPs of 652 eyes (326 patients) were measured with both GAT and Tonosafe, with a range of 3-34 mm Hg. Linear regression analysis showed R=0.93, slope=0.91, both of which supported the proposed hypothesis, and the y-intercept=-1.05 was significantly different from the hypothesized value. The Tonosafe test-retest repeatability (40 eyes of 40 patients), r=0.977, was very high, which was further supported by linear regression slope=0.993, y-intercept=0.118, and a Tonosafe repeatability coefficient of 2.06, similar to GAT repeatability. The IOP measurements by Tonosafe disposable prisms correlated closely with Goldmann measurements, with similar repeated measurement variability to GAT. This suggests that the Tonosafe is an acceptable substitute for GAT to measure IOP in ophthalmology clinic settings.

Reliability of tonosafe disposable tonometer prisms: clinical implications from the Veterans Affairs Boston Healthcare System Quality Assurance Study

PubMed Central

Thomas, V; Daly, M K; Cakiner-Egilmez, T; Baker, E

2011-01-01

Purpose Given the Veterans Affairs Boston Healthcare System's recent introduction of single-use Tonosafe disposable tonometer prisms as an alternative to Goldmann applanation tonometers (GATs), this study had two aims: to conduct a large-scale quality assurance trial to assess the reliability of intraocular pressure (IOP) measurements of the Tonosafe disposable tonometer compared with GAT, particularly at extremes of pressure; to evaluate the suitability of Tonosafe disposable tonometer prisms as an acceptable substitute for GATs and for clinic-wide implementation in an academic tertiary referral setting. Methods Ophthalmology resident physicians measured the IOPs of patients in general and specialty eye clinics with the Tonosafe disposable tonometer and GAT. Tonosafe test–retest reliability data were also collected. A retrospective review of patient charts and data analysis were performed to determine the reliability of measurements. Results The IOPs of 652 eyes (326 patients) were measured with both GAT and Tonosafe, with a range of 3–34 mm Hg. Linear regression analysis showed R=0.93, slope=0.91, both of which supported the proposed hypothesis, and the y-intercept=−1.05 was significantly different from the hypothesized value. The Tonosafe test–retest repeatability (40 eyes of 40 patients), r=0.977, was very high, which was further supported by linear regression slope=0.993, y-intercept=0.118, and a Tonosafe repeatability coefficient of 2.06, similar to GAT repeatability. Conclusions The IOP measurements by Tonosafe disposable prisms correlated closely with Goldmann measurements, with similar repeated measurement variability to GAT. This suggests that the Tonosafe is an acceptable substitute for GAT to measure IOP in ophthalmology clinic settings. PMID:21455241

Cost-effectiveness analysis of lapatinib in HER-2-positive advanced breast cancer.

PubMed

Le, Quang A; Hay, Joel W

2009-02-01

A recent clinical trial demonstrated that the addition of lapatinib to capecitabine in the treatment of HER-2-positive advanced breast cancer (ABC) significantly increases median time to progression. The objective of the current analysis was to assess the cost-effectiveness of this therapy from the US societal perspective. A Markov model comprising 4 health states (stable disease, respond-to-therapy, disease progression, and death) was developed to estimate the projected-lifetime clinical and economic implications of this therapy. The model used Monte Carlo simulation to imitate the clinical course of a typical patient with ABC and updated with response rates and major adverse effects. Transition probabilities were estimated based on the results from the EGF100151 and EGF20002 clinical trials of lapatinib. Health state utilities, direct and indirect costs of the therapy, major adverse events, laboratory tests, and costs of disease progression were obtained from published sources. The model used a 3% discount rate and reported in 2007 US dollars. Over a lifetime, the addition of lapatinib to capecitabine as combination therapy was estimated to cost an additional $19,630, with an expected gain of 0.12 quality-adjusted life years (QALY) or an incremental cost-effectiveness ratio (ICER) of $166,113 per QALY gained. The 95% confidence limits of the ICER ranged from $158,000 to $215,000/QALY. A cost-effectiveness acceptability curve indicated less than 1% probability that the ICER would be lower than $100,000/QALY. Compared with commonly accepted willingness-to-pay thresholds in oncology treatment, the addition of lapatinib to capecitabine is not clearly cost-effective; and most likely to result in an ICER somewhat higher than the societal willingness-to-pay threshold limits. (c) 2008 American Cancer Society.

Evaluation of computerized decision support for oral anticoagulation management based in primary care.

PubMed

Fitzmaurice, D A; Hobbs, F D; Murray, E T; Bradley, C P; Holder, R

1996-09-01

Increasing indications for oral anticoagulation has led to pressure on general practices to undertake therapeutic monitoring. Computerized decision support (DSS) has been shown to be effective in hospitals for improving clinical management. Its usefulness in primary care has previously not been investigated. To test the effectiveness of using DSS for oral anticoagulation monitoring in primary care by measuring the proportions of patients adequately controlled, defined as within the appropriate therapeutic range of International Normalised Ratio (INR). All patients receiving warfarin from two Birmingham inner city general practices were invited to attend a practice-based anticoagulation clinic. In practice A all patients were managed using DSS. In practice B patients were randomized to receive dosing advice either through DSS or through the local hospital laboratory. Clinical outcomes, adverse events and patient acceptability were recorded. Forty-nine patients were seen in total. There were significant improvements in INR control from 23% to 86% (P > 0.001) in the practice where all patients received dosing through DSS. In the practice where patients were randomized to either DSS or hospital dosing, logistic regression showed a significant trend for improvement in intervention patients which was not apparent in the hospital-dosed patients (P < 0.001). Mean recall times were significantly extended in patients who were dosed by the practice DSS through the full 12 months (24 days to 36 days) (P = 0.033). Adverse events were comparable between hospital and practice-dosed patients, although a number of esoteric events occurred. Patient satisfaction with the practice clinics was high. Computerized DSS enables the safe and effective transfer of anticoagulation management from hospital to primary care and may result in improved patient outcome in terms of the level of control, frequency of review and general acceptability.

Rules and guidelines in clinical practice: a qualitative study in operating theatres of doctors' and nurses' views

PubMed Central

McDonald, R; Waring, J; Harrison, S; Walshe, K; Boaden, R

2005-01-01

Background: The current orthodoxy within patient safety research and policy is characterised by a faith in rules based systems which limit the capacity for individual discretion, and hence fallibility. However, guidelines have been seen as stifling innovation and eroding trust. Our objectives were to explore the attitudes towards guidelines of doctors and nurses working together in surgical teams and to examine the extent to which trusting relationships are maintained in a context governed by explicit rules. Methods: Fourteen consultant grade surgeons of mixed specialty, 12 consultant anaesthetists, and 15 nurses were selected to reflect a range of roles. Participant observation was combined with semi-structured interviews. Results: Doctors' views about the contribution of guidelines to safety and to clinical practice differed from those of nurses. Doctors rejected written rules, instead adhering to the unwritten rules of what constitutes acceptable behaviour for members of the medical profession. In contrast, nurses viewed guideline adherence as synonymous with professionalism and criticised doctors for failing to comply with guidelines. Conclusions: While the creation of a "safety culture" requires a shared set of beliefs, attitudes and norms in relation to what is seen as safe clinical practice, differences of opinion on these issues exist which cannot be easily reconciled since they reflect deeply ingrained beliefs about what constitutes professional conduct. While advocates of standardisation (such as nurses) view doctors as rule breakers, doctors may not necessarily regard guidelines as legitimate or identify with the rules written for them by members of other social groups. Future safety research and policy should attempt to understand the unwritten rules which govern clinical behaviour and examine the ways in which such rules are produced, maintained, and accepted as legitimate. PMID:16076795

Development of a novel remote patient monitoring system: the advanced symptom management system for radiotherapy to improve the symptom experience of patients with lung cancer receiving radiotherapy.

PubMed

Maguire, Roma; Ream, Emma; Richardson, Alison; Connaghan, John; Johnston, Bridget; Kotronoulas, Grigorios; Pedersen, Vibe; McPhelim, John; Pattison, Natalie; Smith, Allison; Webster, Lorraine; Taylor, Anne; Kearney, Nora

2015-01-01

The use of technology-enhanced patient-reported outcome measures to monitor the symptoms experienced by people with cancer is an effective way to offer timely care. This study aimed to (a) explore the feasibility and acceptability of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy and clinicians involved in their care and (b) assess changes in patient outcomes during implementation of the Advanced Symptom Management System with patients with lung cancer receiving radiotherapy in clinical practice. A repeated-measures, single-arm, mixed-methods study design was used involving poststudy interviews and completion of patient-reported outcome measures at baseline and end of treatment with 16 patients with lung cancer and 13 clinicians who used this mobile phone-based symptom monitoring system. Only rarely did patients report problems in using the handset and they felt that the system covered all relevant symptoms and helped them to manage their symptoms and effectively communicate with clinicians. Clinical improvements in patient anxiety, drowsiness, and self-care self-efficacy were also observed. Clinicians perceived the use of "real-time" risk algorithms and automated self-care advice provided to patients as positively contributing to clinical care. Reducing the complexity of the system was seen as important to promote its utility. Although preliminary, these results suggest that monitoring patient symptoms using mobile technology in the context of radiotherapy for lung cancer is feasible and acceptable in clinical practice. Future research would be most beneficial if the use of this technology was focused on the postradiotherapy phase and expanded the scope of the system to encompass a wider range of supportive care needs.

Relationships Between Personal Beliefs and Treatment Acceptability, and Preferences for Behavioral Treatments

PubMed Central

Sidani, Souraya; Miranda, Joyal; Epstein, Dana R.; Bootzin, Richard R.; Cousins, Jennifer; Moritz, Patricia

2009-01-01

Background The literature on preferences for behavioral interventions is limited in terms of understanding treatment-related factors that underlie treatment choice. The objectives of this study were to examine the direct relationships between personal beliefs about clinical condition, perception of treatment acceptability, and preferences for behavioral interventions for insomnia. Methods The data set used in this study was obtained from 431 persons with insomnia who participated in a partially randomized clinical trial and expressed preferences for treatment options. The data were collected at baseline. Logistic regression was used to examine the relationships between personal beliefs and treatment acceptability, and preferences. The relationships between personal beliefs and perception of treatment acceptability were explored with correlational analysis. Results Perception of treatment acceptability was associated with preferences. Persons viewing the option as convenient tended to choose that option for managing insomnia. Personal beliefs were not related to preferences. However, beliefs about sleep promoting behaviors were correlated with perceived treatment effectiveness. Conclusions Perception of treatment acceptability underlies expressed preferences for behavioral interventions. Personal beliefs about insomnia are not directly associated with preferences. Importance is highlighted for providing information about treatment options and exploring perception of each option’s acceptability during the process of treatment selection. PMID:19604500

Continuation of Long-Term Care for Cervical Dystonia at an Academic Movement Disorders Clinic

PubMed Central

Gill, Chandler E.; Manus, Neil D.; Pelster, Michael W.; Cook, Jason A.; Title, Wallace; Molinari, Anna L.; Charles, David

2013-01-01

Patients with cervical dystonia (CD) receive much of their care at university based hospital outpatient clinics. This study aimed to describe the clinical characteristics and treatment experiences of patients who continued care at our university based movement disorders clinic, and to document the reasons for which a subset discontinued care. Seventy patients (77% female) were recruited from all patients at the clinic (n = 323). Most (93%) were treated with botulinum neurotoxin (BoNT) injection, and onabotulinumtoxinA was initially used in 97%. The average dose of onabotulinumtoxinA was 270.4 U (range 50–500) and the median number of injections was 14 (range: 1–39). Twenty one patients later received at least one cycle of rimabotulinumtoxinB (33%); of those, 10 switched back to onabotulinumtoxinA (48%). The initial rimabotulinumtoxinB dose averaged 11,996 units (range: 3000–25,000 over 1–18 injections). Twenty one patients (30%) discontinued care. Reasons cited included suboptimal response to BoNT therapy (62%), excessive cost (24%), excessive travel burden (10%), and side effects of BoNT therapy (10%). Most patients (76%) did not seek further care after leaving the clinic. Patients who terminated care received fewer treatment cycles (5.5 vs. 13.0, p = 0.020). There were no other identifiable differences between groups in gender, age, disease characteristics, toxin dose, or toxin formulation. These results indicate that a significant number of CD patients discontinue care due to addressable barriers to access, including cost and travel burden, and that when leaving specialty care, patients often discontinue treatment altogether. These data highlight the need for new initiatives to reduce out-of-pocket costs, as well as training for community physicians on neurotoxin injection in order to lessen the travel burden patients must accept in order to receive standard-of-care treatments. PMID:23612751

Portfolio: a prototype workstation for development and evaluation of tools for analysis and management of digital portal images.

PubMed

Boxwala, A A; Chaney, E L; Fritsch, D S; Friedman, C P; Rosenman, J G

1998-09-01

The purpose of this investigation was to design and implement a prototype physician workstation, called PortFolio, as a platform for developing and evaluating, by means of controlled observer studies, user interfaces and interactive tools for analyzing and managing digital portal images. The first observer study was designed to measure physician acceptance of workstation technology, as an alternative to a view box, for inspection and analysis of portal images for detection of treatment setup errors. The observer study was conducted in a controlled experimental setting to evaluate physician acceptance of the prototype workstation technology exemplified by PortFolio. PortFolio incorporates a windows user interface, a compact kit of carefully selected image analysis tools, and an object-oriented data base infrastructure. The kit evaluated in the observer study included tools for contrast enhancement, registration, and multimodal image visualization. Acceptance was measured in the context of performing portal image analysis in a structured protocol designed to simulate clinical practice. The acceptability and usage patterns were measured from semistructured questionnaires and logs of user interactions. Radiation oncologists, the subjects for this study, perceived the tools in PortFolio to be acceptable clinical aids. Concerns were expressed regarding user efficiency, particularly with respect to the image registration tools. The results of our observer study indicate that workstation technology is acceptable to radiation oncologists as an alternative to a view box for clinical detection of setup errors from digital portal images. Improvements in implementation, including more tools and a greater degree of automation in the image analysis tasks, are needed to make PortFolio more clinically practical.

Caregiver acceptability and preferences for early childhood caries preventive treatments for Hispanic children.

PubMed

Adams, Sally H; Hyde, Susan; Gansky, Stuart A

2009-01-01

The objective of this study was to determine caregiver treatment acceptability and preferences for five preventive dental treatments for early childhood caries in young Hispanic children. We interviewed 211 parents/caregivers of Hispanic children attending Head Start programs regarding their acceptability of, and preferences for, five standard preventive dental treatments for young children. Treatments assessed were toothbrushing with fluoride toothpaste, fluoride varnish, and xylitol in food for children, and xylitol gum and chlorhexidine rinse for mothers. The interview assessment included presentation of illustrated cards with verbal description of treatment, photograph/video clip, and treatment samples. Parents rated the acceptability of each treatment (1-5 scale) and treatment preferences within each of 10 possible pairs. Individual treatment preferences were summed to create overall preference scores (range 0-4). All treatments were rated as highly acceptable, however, there were differences (range 4.6-4.9; Friedman chi-square = 23.4, P < 0.001). Chlorhexidine, toothbrushing, and varnish were most acceptable, not different from each other, but more acceptable than xylitol in food (P < 0.05). Summed treatment preferences revealed greater variability (means ranged 1.4-2.6; Friedman chi-square = 128.2, P < 0.001). Fluoride varnish (2.6) and toothbrushing (2.5) were most highly preferred, and differences between preferences for xylitol in food (1.4), xylitol gum (1.5), and chlorhexidine (2.1) were all significant (P < 0.001). Preferences for chlorhexidine were also significantly greater than those for the xylitol products (P < 0.001). All five treatments were highly acceptable, however, when choosing among treatments overall, fluoride varnish and toothbrushing were favored over other treatments.

The Green Card Clinic: overview of a brief patient-centred intervention following deliberate self-harm.

PubMed

Wilhelm, Kay; Finch, Adam; Kotze, Beth; Arnold, Karen; McDonald, Geoff; Sternhell, Peter; Hudson, Beaver

2007-02-01

The aim of this study was to present an overview of the Green Card Clinic, a novel brief intervention service for patients presenting to the emergency department following deliberate self-harm (DSH) or with suicidal ideation, to examine its effectiveness in terms of service utilization, and patient and clinician feedback, and to explore the correlates of repeated DSH. The aims and structure of the Green Card Clinic are described. We highlight our patient-centred approach involving self-identification of difficulties from a list of problem areas, coupled with tailored intervention strategies. Relevant data are presented and characteristics of repeat DSH patients are compared to the first-episode group. Between 1998 and 2005, 456 DSH patients were referred to the clinic. Of these, 75% (n = 344) attended the first session, 43% (n = 197) the second session, 26% (n = 117) the third session, and 16% (n = 73) completed a 3-15 month follow-up. Clinic attenders (mean age 31.6 years, 57% female) reported a diverse range of self-identified problems and repeat DSH patients reported worse depression, poorer health-related behaviours, and a greater number of problems than those presenting after first-episode DSH. The clinic achieved high rates of first session attendance. This may have been attributable to the use of a few specific strategies aimed at increasing compliance, such as the green card, next-day appointments and assertive follow-up of non-attenders. For repeat self-harmers, we advocate an approach aimed at 'lifestyle change' rather than based on current psychological stressors. The Green Card Clinic service, involving a range of interventions tailored to meet the multitude of presenting needs, appears to be an acceptable and flexible approach to brief intervention for DSH.

Vienna international summer school on experimental and clinical oncology for medical students: an Austrian cancer education project.

PubMed

Fromm-Haidenberger, Sabine; Pohl, Gudrun; Widder, Joachim; Kren, Gerhard; Fitzal, Florian; Bartsch, Rupert; de Vries, Jakob; Zielinski, Christoph; Pötter, Richard

2010-03-01

The "International Summer School on Experimental and Clinical Oncology for Medical Students" is organised at the Medical University of Vienna to teach a multidisciplinary approach to oncology to medical students in the final phase of their studies. The program includes biology, diagnosis, clinical and psycho-oncology. Lectures are given by medical, radiation and surgical oncologists. Teaching includes case reports, poster presentations and role-play. As part of the organising committee, Austrian students organise a social program. Since 1999, six courses have been held (147 students from 19 countries). Students recorded high satisfaction with organisation, scientific content and topic range. Case presentations, poster presentations and role-play were very useful. Early criticism that the program was too intense (long lectures and little interaction) has been answered. The summer school has a high degree of acceptance and is a very useful tool to teach medical students about oncology and approaching a cancer patient.

14 CFR 1274.505 - Procurement procedures.

Code of Federal Regulations, 2010 CFR

2010-01-01

... performance, financial and technical resources or accessibility to other necessary resources. In certain... or performance required, including the range of acceptable characteristics or minimum acceptable...

Fiber optic video monitoring system for remote CT/MR scanners clinically accepted

NASA Astrophysics Data System (ADS)

Tecotzky, Raymond H.; Bazzill, Todd M.; Eldredge, Sandra L.; Tagawa, James; Sayre, James W.

1992-07-01

With the proliferation of CT travel to distant scanners to review images before their patients can be released. We designed a fiber-optic broadband video system to transmit images from seven scanner consoles to fourteen remote monitoring stations in real time. This system has been used clinically by radiologists for over one years. We designed and conducted a user survey to categorize the levels of system use by section (Chest, GI, GU, Bone, Neuro, Peds, etc.), to measure operational utilization and acceptance of the system into the clinical environment, to clarify the system''s importance as a clinical tool for saving radiologists travel-time to distant CT the system''s performance and limitations as a diagnostic tool. The study was administered directly to radiologists using a printed survey form. The results of the survey''s compiled data show a high percentage of system usage by a wide spectrum of radiologists. Clearly, this system has been accepted into the clinical environment as a highly valued diagnostic tool in terms of time savings and functional flexibility.

Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology.

PubMed

Abernethy, Amy P; Herndon, James E; Wheeler, Jane L; Day, Jeannette M; Hood, Linda; Patwardhan, Meenal; Shaw, Heather; Lyerly, Herbert Kim

2009-06-01

Programmed, notebook-style, personal computers ("e/Tablets") can collect symptom and quality-of-life (QOL) data at the point of care. Patients use an e/Tablet in the clinic waiting area to complete electronic surveys. Information then travels wirelessly to a server, which generates a real-time report for use during the clinical visit. The objective of this study was to determine whether academic oncology patients find e/Tablets logistically acceptable and a satisfactory means of communicating symptoms to providers during repeated clinic visits. Sixty-six metastatic breast cancer patients at Duke Breast Cancer Clinic participated. E/Tablets were customized to electronically administer a satisfaction/acceptability survey, several validated questionnaires, and the Patient Care Monitor (PCM) review of symptoms survey. At each of the four visits within six months, participants completed the patient satisfaction/acceptability survey, which furnished data for the current analysis. Participant demographics were: mean age of 54 years, 77% Caucasian, and 47% with less than a college education. Participants reported that e/Tablets were easy to read (94%), easy to navigate (99%), and had a comfortable weight (90%); they found it easy to respond to questions using the e/Tablet (98%). Seventy-five percent initially indicated satisfaction with PCM for reporting symptoms; this proportion increased over time. By the last visit, 88% of participants indicated that they would recommend the PCM to other patients; 74% felt that the e/Tablet helped them remember symptoms to report to their clinician. E/Tablets offered a feasible and acceptable method for collecting longitudinal patient-reported symptom and QOL data within an academic, tertiary care, breast cancer clinic.

The Geographic Distribution, Ownership, Prices, and Scope of Practice at Retail Clinics

PubMed Central

Rudavsky, Rena; Pollack, Craig Evan; Mehrotra, Ateev

2009-01-01

BACKGROUND As a new model of care in the United States (US), retail clinics have generated much interest. Located physically within a retail store, they provide simple acute and preventive care services for a fixed price and without an appointment. OBJECTIVE To describe where retail clinics have opened in the US, their ownership structure, scope of practice, prices, acceptance of insurance, and the fraction of the population that lives within a short driving distance of a clinic. DESIGN Cross-sectional descriptive study SAMPLE All retail clinics operating in the US as of August 2008 MEASUREMENTS Population living within five and ten-minute driving distances of a retail clinic RESULTS In August 2008, 42 operators ran 982 clinics in 33 states; 88.4% were located in urban areas. An estimated 13.4% and 35.8% of the US urban population lives within a five-minute and ten-minute driving distance respectively from a retail clinic. The proportion of the population that lives close to a retail clinic is higher than 50 percent in some cities such as Nashville (56.7% five-minute, 93.7% ten-minute) and Minneapolis-St. Paul, MN (50.9%, 96.0%). The majority of retail clinic operators (25, 59.5%) are hospital chains and/or physician groups, but they only operate 11.4% of the clinics nationally. Simple acute conditions, skin conditions, and immunizations make up the majority of retail clinics’ limited scope of practice. Across operators, those without insurance paid on average $78 for a sore throat visit and $63 for an adult tetanus booster vaccine. In a random sample of clinics, we found that 97% accepted private insurance, 93% accepted Medicare fee-for-service, and 60% accepted some form of Medicaid. LIMITATIONS Geographic access is only one of many factors that influence whether an individual visits a retail clinic CONCLUSIONS Retail clinics can provide care for simple acute conditions and immunizations for a significant segment of the urban US population. PRIMARY FUNDING California Healthcare Foundation PMID:19721019

Current perceptions of the term Clinical Pharmacy and its relationship to Pharmaceutical Care: a survey of members of the European Society of Clinical Pharmacy.

PubMed

Dreischulte, Tobias; Fernandez-Llimos, Fernando

2016-12-01

Background The definitions that are being used for the terms 'clinical pharmacy' and 'pharmaceutical care' seem to have a certain overlap. Responsibility for therapy outcomes seems to be especially linked to the latter term. Both terms need clarification before a proper definition of clinical pharmacy can be drafted. Objective To identify current disagreements regarding the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care' and to assess to which extent pharmacists with an interest in Clinical Pharmacy are willing to accept responsibility for drug therapy outcomes. Setting The membership of the European Society of Clinical Pharmacy. Methods A total of 1,285 individuals affiliated with the European Society of Clinical Pharmacy were invited by email to participate in an online survey asking participants to state whether certain professional activities, providers, settings, aims and general descriptors constituted (a) 'Clinical Pharmacy only', (b) 'Pharmaceutical Care only', (c) 'both' or (d) 'neither'. Further questions examined pharmacists' willingness to accept ethical or legal responsibility for drug therapy outcomes, under current and ideal working conditions. Main outcome measures Level of agreement with a number of statements. Results There was disagreement (<80% agreement among all participants) regarding 'Clinical Pharmacy' activities, whether non-pharmacists could provide 'Clinical Pharmacy' services, and whether such services could be provided in non-hospital settings. There was disagreement (<80% agreement among those linking items to Clinical Pharmacy) as to whether Pharmaceutical care also encompassed certain professional activities, constituted a scientific discipline and targeted cost effectiveness. The proportions of participants willing to accept legal responsibility under current/ideal working conditions were: safety (32.7%/64.3%), effectiveness (17.9%/49.2%), patient-centeredness (17.1%/46.2%), cost-effectiveness (20.3%/44.0%). Conclusions The survey identified key disagreements around the term 'Clinical Pharmacy' and its relationship to 'Pharmaceutical Care', which future discussions around a harmonised definition of 'Clinical Pharmacy' should aim to resolve. Further research is required to understand barriers and facilitators to pharmacists accepting responsibility for drug therapy outcomes.

Model depicting aspects of audit and feedback that impact physicians' acceptance of clinical performance feedback.

PubMed

Payne, Velma L; Hysong, Sylvia J

2016-07-13

Audit and feedback (A&F) is a strategy that has been used in various disciplines for performance and quality improvement. There is limited research regarding medical professionals' acceptance of clinical-performance feedback and whether feedback impacts clinical practice. The objectives of our research were to (1) investigate aspects of A&F that impact physicians' acceptance of performance feedback; (2) determine actions physicians take when receiving feedback; and (3) determine if feedback impacts physicians' patient-management behavior. In this qualitative study, we employed grounded theory methods to perform a secondary analysis of semi-structured interviews with 12 VA primary care physicians. We analyzed a subset of interview questions from the primary study, which aimed to determine how providers of high, low and moderately performing VA medical centers use performance feedback to maintain and improve quality of care, and determine perceived utility of performance feedback. Based on the themes emergent from our analysis and their observed relationships, we developed a model depicting aspects of the A&F process that impact feedback acceptance and physicians' patient-management behavior. The model is comprised of three core components - Reaction, Action and Impact - and depicts elements associated with feedback recipients' reaction to feedback, action taken when feedback is received, and physicians modifying their patient-management behavior. Feedback characteristics, the environment, external locus-of-control components, core values, emotion and the assessment process induce or deter reaction, action and impact. Feedback characteristics (content and timeliness), and the procedural justice of the assessment process (unjust penalties) impact feedback acceptance. External locus-of-control elements (financial incentives, competition), the environment (patient volume, time constraints) and emotion impact patient-management behavior. Receiving feedback generated intense emotion within physicians. The underlying source of the emotion was the assessment process, not the feedback. The emotional response impacted acceptance, impelled action or inaction, and impacted patient-management behavior. Emotion intensity was associated with type of action taken (defensive, proactive, retroactive). Feedback acceptance and impact have as much to do with the performance assessment process as it does the feedback. In order to enhance feedback acceptance and the impact of feedback, developers of clinical performance systems and feedback interventions should consider multiple design elements.

The relaxation response resiliency program (3RP) in patients with neurofibromatosis 1, neurofibromatosis 2, and schwannomatosis: results from a pilot study.

PubMed

Vranceanu, Ana-Maria; Merker, Vanessa L; Plotkin, Scott R; Park, Elyse R

2014-10-01

NF1, NF2, and Schwannomatosis are incurable tumor suppressor syndromes associated with poor quality of life. The aim of this study was to determine the feasibility, acceptability, and preliminary efficacy of an NF adapted, 8-week group mind body skills based intervention, the relaxation response resiliency program (3RP) aimed at improving resiliency and increasing satisfaction with life. Patients seen at MGH's Neurofibromatosis Clinic were offered participation if they described difficulties coping to a treating physician. Participants completed measures of life satisfaction, resiliency, stress, mood, lifestyle, pain, post-traumatic growth and mindfulness at baseline and after completing the 3RP program. The intervention had relative feasible enrollment rate (48% rate, 32 out of 67 of patients signing the informed consent form). However, out of the 32 patients who signed the informed consent, only 20 started the study (62.5%) and only 16 completed it (50%), suggesting problems with feasibility. The main reason cited for non-participation was burden of travel to the clinic. The intervention was highly acceptable, as evidenced by an 80% completion rate (16/20). Paired t tests showed significant improvement in resiliency, satisfaction with life, depression, stress, anxiety, mindfulness and post traumatic growth, with effect sizes ranging from 0.73-1.33. There was a trend for significance for improvement in somatization and sleepiness (p = 0.06), with effect sizes of 0.54-0.92 respectively. Statistically nonsignificant improvement was observed in all other measures, with effect sizes small to medium. In sum, the 3RP was found to be relatively feasible, highly acceptable and preliminary efficacious in decreasing symptom burden in this population, supporting the need of a randomized controlled trial.

PedsQL™ Multidimensional Fatigue Scale in sickle cell disease: feasibility, reliability, and validity.

PubMed

Panepinto, Julie A; Torres, Sylvia; Bendo, Cristiane B; McCavit, Timothy L; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W

2014-01-01

Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77-0.84; parent proxy-report α = 0.90-0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. © 2013 Wiley Periodicals, Inc.

PedsQL™ Multidimensional Fatigue Scale in Sickle Cell Disease: Feasibility, Reliability and Validity

PubMed Central

Panepinto, Julie A.; Torres, Sylvia; Bendo, Cristiane B.; McCavit, Timothy L.; Dinu, Bogdan; Sherman-Bien, Sandra; Bemrich-Stolz, Christy; Varni, James W.

2013-01-01

Background Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5–18 years and parent proxy-report for ages 2–18 years. Procedure This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. Results The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77–0.84; parent proxy-report α = 0.90–0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥ 0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. Conclusions The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice. PMID:24038960

What Does It Take to Change an Editor's Mind? Identifying Minimally Important Difference Thresholds for Peer Reviewer Rating Scores of Scientific Articles.

PubMed

Callaham, Michael; John, Leslie K

2018-01-05

We define a minimally important difference for the Likert-type scores frequently used in scientific peer review (similar to existing minimally important differences for scores in clinical medicine). The magnitude of score change required to change editorial decisions has not been studied, to our knowledge. Experienced editors at a journal in the top 6% by impact factor were asked how large a change of rating in "overall desirability for publication" was required to trigger a change in their initial decision on an article. Minimally important differences were assessed twice for each editor: once assessing the rating change required to shift the editor away from an initial decision to accept, and the other assessing the magnitude required to shift away from an initial rejection decision. Forty-one editors completed the survey (89% response rate). In the acceptance frame, the median minimally important difference was 0.4 points on a scale of 1 to 5. Editors required a greater rating change to shift from an initial rejection decision; in the rejection frame, the median minimally important difference was 1.2 points. Within each frame, there was considerable heterogeneity: in the acceptance frame, 38% of editors did not change their decision within the maximum available range; in the rejection frame, 51% did not. To our knowledge, this is the first study to determine the minimally important difference for Likert-type ratings of research article quality, or in fact any nonclinical scientific assessment variable. Our findings may be useful for future research assessing whether changes to the peer review process produce clinically meaningful differences in editorial decisionmaking. Copyright © 2017 American College of Emergency Physicians. Published by Elsevier Inc. All rights reserved.

Quantitative analysis of image quality for acceptance and commissioning of an MRI simulator with a semiautomatic method.

PubMed

Chen, Xinyuan; Dai, Jianrong

2018-05-01

Magnetic Resonance Imaging (MRI) simulation differs from diagnostic MRI in purpose, technical requirements, and implementation. We propose a semiautomatic method for image acceptance and commissioning for the scanner, the radiofrequency (RF) coils, and pulse sequences for an MRI simulator. The ACR MRI accreditation large phantom was used for image quality analysis with seven parameters. Standard ACR sequences with a split head coil were adopted to examine the scanner's basic performance. The performance of simulation RF coils were measured and compared using the standard sequence with different clinical diagnostic coils. We used simulation sequences with simulation coils to test the quality of image and advanced performance of the scanner. Codes and procedures were developed for semiautomatic image quality analysis. When using standard ACR sequences with a split head coil, image quality passed all ACR recommended criteria. The image intensity uniformity with a simulation RF coil decreased about 34% compared with the eight-channel diagnostic head coil, while the other six image quality parameters were acceptable. Those two image quality parameters could be improved to more than 85% by built-in intensity calibration methods. In the simulation sequences test, the contrast resolution was sensitive to the FOV and matrix settings. The geometric distortion of simulation sequences such as T1-weighted and T2-weighted images was well-controlled in the isocenter and 10 cm off-center within a range of ±1% (2 mm). We developed a semiautomatic image quality analysis method for quantitative evaluation of images and commissioning of an MRI simulator. The baseline performances of simulation RF coils and pulse sequences have been established for routine QA. © 2018 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Negotiating explanations: doctor-patient communication with patients with medically unexplained symptoms-a qualitative analysis.

PubMed

den Boeft, Madelon; Huisman, Daniëlle; Morton, LaKrista; Lucassen, Peter; van der Wouden, Johannes C; Westerman, Marjan J; van der Horst, Henriëtte E; Burton, Christopher D

2017-02-01

Patients with medically unexplained physical symptoms (MUPS) seek explanations for their symptoms, but often find general practitioners (GPs) unable to deliver these. Different methods of explaining MUPS have been proposed. Little is known about how communication evolves around these explanations. To examine the dialogue between GPs and patients related to explanations in a community-based clinic for MUPS. We categorized dialogue types and dialogue outcomes. Patients were ≥18 years with inclusion criteria for moderate MUPS: ≥2 referrals to specialists, ≥1 functional syndrome/symptoms, ≥10 on the Patient Health Questionnaire-15 and GP's judgement that symptoms were unexplained. We analysed transcripts of 112 audio-recorded consultations (39 patients and 5 GPs) from two studies on the Symptoms Clinic Intervention, a consultation intervention for MUPS in primary care. We used constant comparative analysis to code and classify dialogue types and outcomes. We extracted 115 explanation sequences. We identified four dialogue types, differing in the extent to which the GP or patient controlled the dialogue. We categorized eight outcomes of the sequences, ranging from acceptance to rejection by the patient. The most common outcome was holding (conversation suspended in an unresolved state), followed by acceptance. Few explanations were rejected by the patient. Co-created explanations by patient and GP were most likely to be accepted. We developed a classification of dialogue types and outcomes in relation to explanations offered by GPs for MUPS patients. While it requires further validation, it provides a framework, which can be used for teaching, evaluation of practice and research. © The Author 2016. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

The Technology Acceptance Model for Resource-Limited Settings (TAM-RLS): A Novel Framework for Mobile Health Interventions Targeted to Low-Literacy End-Users in Resource-Limited Settings.

PubMed

Campbell, Jeffrey I; Aturinda, Isaac; Mwesigwa, Evans; Burns, Bridget; Santorino, Data; Haberer, Jessica E; Bangsberg, David R; Holden, Richard J; Ware, Norma C; Siedner, Mark J

2017-11-01

Although mobile health (mHealth) technologies have shown promise in improving clinical care in resource-limited settings (RLS), they are infrequently brought to scale. One limitation to the success of many mHealth interventions is inattention to end-user acceptability, which is an important predictor of technology adoption. We conducted in-depth interviews with 43 people living with HIV in rural Uganda who had participated in a clinical trial of a short messaging system (SMS)-based intervention designed to prompt return to clinic after an abnormal laboratory test. Interviews focused on established features of technology acceptance models, including perceived ease of use and perceived usefulness, and included open-ended questions to gain insight into unexplored issues related to the intervention's acceptability. We used conventional (inductive) and direct content analysis to derive categories describing use behaviors and acceptability. Interviews guided development of a proposed conceptual framework, the technology acceptance model for resource-limited settings (TAM-RLS). This framework incorporates both classic technology acceptance model categories as well as novel factors affecting use in this setting. Participants described how SMS message language, phone characteristics, and experience with similar technologies contributed to the system's ease of use. Perceived usefulness was shaped by the perception that the system led to augmented HIV care services and improved access to social support from family and colleagues. Emergent themes specifically related to mHealth acceptance among PLWH in Uganda included (1) the importance of confidentiality, disclosure, and stigma, and (2) the barriers and facilitators downstream from the intervention that impacted achievement of the system's target outcome. The TAM-RLS is a proposed model of mHealth technology acceptance based upon end-user experiences in rural Uganda. Although the proposed model requires validation, the TAM-RLS may serve as a useful tool to guide design and implementation of mHealth interventions.

Embodied Cognition and the Direct Induction of Affect as a Compliment to Cognitive Behavioural Therapy †

PubMed Central

Pietrzak, Tania; Lohr, Christina; Jahn, Beverly; Hauke, Gernot

2018-01-01

We make the case for the possible integration of affect experience induced via embodiment techniques with CBT for the treatment of emotional disorders in clinical settings. Theoretically we propose a possible integration of cognitive behavioural theory, neuroscience, embodied cognition and important processes of client change outcomes such as the therapeutic alliance to enhance client outcomes. We draw from evidence of bidirectional effects between embodiment modes of bottom-up (sensory-motor simulations giving rise to important basis of knowledge) and top-down (abstract mental representations of knowledge) processes such as CBT in psychotherapy. The paper first describes the dominance and success of CBT for the treatment of a wide range of clinical disorders. Some limitations of CBT, particularly for depression are also outlined. There is a growing body of evidence for the added value of experiential affect-focused interventions combined with CBT. Evidence for the embodied model of cognition and emotion is reviewed. Advantages of embodiment is highlighted as a complimentary process model to deepen the intensity and valence of affective experience. It is suggested that an integrated embodiment approach with CBT enhances outcomes across a wide range of emotional disorders. A description of our embodiment method integrated with CBT for inducing affective experience, emotional regulation, acceptance of unwanted emotions and emotional mastery is given. Finally, the paper highlights the importance of the therapeutic alliance as a critical component of the change process. The paper ends with a case study highlighting some clinical strategies that may aid the therapist to integrate embodiment techniques in CBT that can further explore in future research on affective experience in CBT for a wider range of clinical disorders. PMID:29495377

Embodied Cognition and the Direct Induction of Affect as a Compliment to Cognitive Behavioural Therapy.

PubMed

Pietrzak, Tania; Lohr, Christina; Jahn, Beverly; Hauke, Gernot

2018-02-26

We make the case for the possible integration of affect experience induced via embodiment techniques with CBT for the treatment of emotional disorders in clinical settings. Theoretically we propose a possible integration of cognitive behavioural theory, neuroscience, embodied cognition and important processes of client change outcomes such as the therapeutic alliance to enhance client outcomes. We draw from evidence of bidirectional effects between embodiment modes of bottom-up (sensory-motor simulations giving rise to important basis of knowledge) and top-down (abstract mental representations of knowledge) processes such as CBT in psychotherapy. The paper first describes the dominance and success of CBT for the treatment of a wide range of clinical disorders. Some limitations of CBT, particularly for depression are also outlined. There is a growing body of evidence for the added value of experiential affect-focused interventions combined with CBT. Evidence for the embodied model of cognition and emotion is reviewed. Advantages of embodiment is highlighted as a complimentary process model to deepen the intensity and valence of affective experience. It is suggested that an integrated embodiment approach with CBT enhances outcomes across a wide range of emotional disorders. A description of our embodiment method integrated with CBT for inducing affective experience, emotional regulation, acceptance of unwanted emotions and emotional mastery is given. Finally, the paper highlights the importance of the therapeutic alliance as a critical component of the change process. The paper ends with a case study highlighting some clinical strategies that may aid the therapist to integrate embodiment techniques in CBT that can further explore in future research on affective experience in CBT for a wider range of clinical disorders.

Effect of self-triage on waiting times at a walk-in sexual health clinic.

PubMed

Hitchings, Samantha; Barter, Janet

2009-10-01

Lengthy waiting times can be a major problem in walk-in sexual health clinics. They are stressful for both patients and staff and may lead to clients with significant health issues leaving the department before being seen by a clinician. A self-triage system may help reduce waiting times and duplication of work, improve patient pathways and decrease wasted visits. This paper describes implementation of a self-triage system in two busy sexual and reproductive health clinics. Patients were asked to complete a self-assessment form on registration to determine the reason for attendance. This then enabled patients to be directed to the most appropriate specialist or clinical service. The benefits of this approach were determined by measuring patient waiting times, reduction in unnecessary specialist review together with patient acceptability as tested by a patient satisfaction survey. The ease of comprehension of the triage form was also assessed by an independent readers' panel. A total of 193 patients were recruited over a 4-month period from November 2004 to February 2005. Patients from the November and December clinics were assigned to the 'traditional treatment' arm, with patients at subsequent clinics being assigned to the 'self-triage' system. Waiting times were collected by the receptionist and clinic staff. Ninety six patients followed the traditional route, 97 the new self-triage system. Sixty-nine (35.8%) patients completed the satisfaction survey. The self-triage system significantly reduced waiting time from 40 (22, 60) to 23 (10, 40) minutes [results expressed as median (interquartile range)]. There was a non-significant reduction in the proportion of patients seeing two clinicians from 21% to 13% (p = 0.17). Satisfaction levels were not significantly altered (95% compared to 97% satisfied, p = 0.64). The readers' panel found the triage form both easy to understand and to complete. Self-triage can effectively reduce clinic waiting times and allow better organisation of resources. Urgent cases can be prioritised. This process appears to be acceptable to and understandable by patients.

Clinical use of computational modeling for surgical planning of arteriovenous fistula for hemodialysis.

PubMed

Bozzetto, Michela; Rota, Stefano; Vigo, Valentina; Casucci, Francesco; Lomonte, Carlo; Morale, Walter; Senatore, Massimo; Tazza, Luigi; Lodi, Massimo; Remuzzi, Giuseppe; Remuzzi, Andrea

2017-03-14

Autogenous arteriovenous fistula (AVF) is the best vascular access (VA) for hemodialysis, but its creation is still a critical procedure. Physical examination, vascular mapping and doppler ultrasound (DUS) evaluation are recommended for AVF planning, but they can not provide direct indication on AVF outcome. We recently developed and validated in a clinical trial a patient-specific computational model to predict pre-operatively the blood flow volume (BFV) in AVF for different surgical configuration on the basis of demographic, clinical and DUS data. In the present investigation we tested power of prediction and usability of the computational model in routine clinical setting. We developed a web-based system (AVF.SIM) that integrates the computational model in a single procedure, including data collection and transfer, simulation management and data storage. A usability test on observational data was designed to compare predicted vs. measured BFV and evaluate the acceptance of the system in the clinical setting. Six Italian nephrology units were involved in the evaluation for a 6-month period that included all incident dialysis patients with indication for AVF surgery. Out of the 74 patients, complete data from 60 patients were included in the final dataset. Predicted brachial BFV at 40 days after surgery showed a good correlation with measured values (in average 787 ± 306 vs. 751 ± 267 mL/min, R = 0.81, p < 0.001). For distal AVFs the mean difference (±SD) between predicted vs. measured BFV was -2.0 ± 20.9%, with 50% of predicted values in the range of 86-121% of measured BFV. Feedbacks provided by clinicians indicate that AVF.SIM is easy to use and well accepted in clinical routine, with limited additional workload. Clinical use of computational modeling for AVF surgical planning can help the surgeon to select the best surgical strategy, reducing AVF early failures and complications. This approach allows individualization of VA care, with the aim to reduce the costs associated with VA dysfunction, and to improve AVF clinical outcome.

Determinants of human papillomavirus vaccine acceptability in Latin America and the Caribbean.

PubMed

Winkler, Jennifer L; Wittet, Scott; Bartolini, Rosario M; Creed-Kanashiro, Hilary M; Lazcano-Ponce, Eduardo; Lewis-Bell, Karen; Lewis, Merle J; Penny, Mary E

2008-08-19

Prophylactic human papillomavirus (HPV) vaccines provide promise as a key component of future cervical cancer prevention programs in the Latin America and the Caribbean region. The successful introduction and acceptance of these vaccines will depend on a range of factors including awareness of cervical cancer as a problem, affordability of the vaccine, political will, competition with other vaccines, feasibility of vaccine delivery and acceptability of the vaccine among the range of groups who will influence uptake. While existing data about acceptability from Latin America and the Caribbean is scarce, it is clear that health policymakers, providers and the general public lack knowledge about HPV and cervical cancer. Furthermore, they would value more local epidemiologic data related to cervical cancer. Price is currently a major barrier to vaccine acceptability and a priority for advocacy. More research is required in Latin America and the Caribbean to determine what messages and strategies will work in these communities.

A methodology for direct quantification of over-ranging length in helical computed tomography with real-time dosimetry.

PubMed

Tien, Christopher J; Winslow, James F; Hintenlang, David E

2011-01-31

In helical computed tomography (CT), reconstruction information from volumes adjacent to the clinical volume of interest (VOI) is required for proper reconstruction. Previous studies have relied upon either operator console readings or indirect extrapolation of measurements in order to determine the over-ranging length of a scan. This paper presents a methodology for the direct quantification of over-ranging dose contributions using real-time dosimetry. A Siemens SOMATOM Sensation 16 multislice helical CT scanner is used with a novel real-time "point" fiber-optic dosimeter system with 10 ms temporal resolution to measure over-ranging length, which is also expressed in dose-length-product (DLP). Film was used to benchmark the exact length of over-ranging. Over-ranging length varied from 4.38 cm at pitch of 0.5 to 6.72 cm at a pitch of 1.5, which corresponds to DLP of 131 to 202 mGy-cm. The dose-extrapolation method of Van der Molen et al. yielded results within 3%, while the console reading method of Tzedakis et al. yielded consistently larger over-ranging lengths. From film measurements, it was determined that Tzedakis et al. overestimated over-ranging lengths by one-half of beam collimation width. Over-ranging length measured as a function of reconstruction slice thicknesses produced two linear regions similar to previous publications. Over-ranging is quantified with both absolute length and DLP, which contributes about 60 mGy-cm or about 10% of DLP for a routine abdominal scan. This paper presents a direct physical measurement of over-ranging length within 10% of previous methodologies. Current uncertainties are less than 1%, in comparison with 5% in other methodologies. Clinical implantation can be increased by using only one dosimeter if codependence with console readings is acceptable, with an uncertainty of 1.1% This methodology will be applied to different vendors, models, and postprocessing methods--which have been shown to produce over-ranging lengths differing by 125%.

Frequency of vital sign assessment and clinical deterioration in an Australian emergency department.

PubMed

Lambe, Katherine; Currey, Judy; Considine, Julie

2016-11-01

Understanding of clinical deterioration of emergency department patients is rapidly evolving. The aim of this study was to investigate the frequency and nature of vital sign collection and clinical deterioration in emergency care. A descriptive exploratory approach was used. Data were collected from the records of 200 randomly selected adults with presenting complaints of abdominal pain, shortness of breath, chest pain and febrile illness from 1 January to 31 December 2014 at a 22 bed emergency department in Melbourne, Australia. When controlled for length of stay, heart rate was the most frequently assessed vital sign per hour (median=0.9) whilst Glasgow Coma Score was the least frequently assessed vital sign per hour (median=0.5). Clinical deterioration (one or more vital signs fulfilling hospital medical emergency team activation criteria during emergency department care) occurred in 14.5% of patients. Of the 5466 vital sign measures, 19.6% were abnormal, 1.9% indicated clinical deterioration. Clinical deterioration occurred in one in seven patients, and one in five vital signs documented were outside of accepted normal ranges. Thus, emergency department physiological status has implications for patient safety and nursing practice, in particular clinical handover for patients requiring hospital admission. Copyright © 2016 College of Emergency Nursing Australasia. Published by Elsevier Ltd. All rights reserved.

Clinical recommendations of cardiac magnetic resonance, Part II: inflammatory and congenital heart disease, cardiomyopathies and cardiac tumors: a position paper of the working group 'Applicazioni della Risonanza Magnetica' of the Italian Society of Cardiology.

PubMed

Pontone, Gianluca; Di Bella, Gianluca; Silvia, Castelletti; Maestrini, Viviana; Festa, Pierluigi; Ait-Ali, Lamia; Masci, Pier Giorgio; Monti, Lorenzo; di Giovine, Gabriella; De Lazzari, Manuel; Cipriani, Alberto; Guaricci, Andrea I; Dellegrottaglie, Santo; Pepe, Alessia; Marra, Martina Perazzolo; Aquaro, Giovanni D

2017-04-01

The current document was developed by the working group on the 'application of cardiac magnetic resonance' of the Italian Society of Cardiology to provide a perspective on the current state of technical advances and clinical cardiac magnetic resonance applications and to inform cardiologists how to implement their clinical and diagnostic pathway with the introduction of this technique in the clinical practice. Appropriateness criteria were defined using a score system: score 1-3 = inappropriate (test is not generally acceptable and is not a reasonable approach for the indication), score 4-6 = uncertain (test may be generally acceptable and may be a reasonable approach for the indication but more research and/or patient information is needed to classify the indication definitively) and score 7-9 = appropriate (test is generally acceptable and is a reasonable approach for the indication).

Female condoms.

PubMed

Bounds, W

1997-06-01

Early versions of a female condom were available in the 1920s and 1960s, but they were little used and soon forgotten. It took the arrival of AIDS, and the urgent need for a wider range of female-controlled barrier techniques, to rekindle scientific interest in this method. In the 1980s, three groups in Europe and the USA began development of new female condom designs, comprising 'Femidom (Reality)', the 'Bikini Condom', and 'Women's Choice'. Apart from differences in their physical design, Femidom differs from the others in that it is made of a polyurethane membrane, which has several advantages over latex. Of the three, Femidom is the most advanced in terms of development and clinical testing, and it is the only one to have reached the marketing stage. Laboratory studies and clinical trials suggest that its contraceptive efficacy is similar to that documented for the male condom, though a direct comparison is not possible because no comparative clinical trials have, as yet, been undertaken. Reported 'typical-use' pregnancy rates range from 12.4 to 22.2% at 6 months of use in the USA and Latin America, respectively, while a study in the UK observed a rate of 15% at 12 months. As with all barrier methods, most failures appear to be associated with poor compliance or incorrect use. 'Perfect-use' pregnancy rates were substantially lower, indicating that Femidom can be very effective, if used consistently and correctly. Evidence for Femidom's effectiveness to protect against transmission of sexual disease-causing organisms, including HIV, is still very limited and based largely on laboratory studies. Whilst, in theory, the condom should confer reliable protection, its efficacy in clinical use will depend upon correct and consistent use and upon the product's ability to maintain an effective physical barrier throughout penetrative intercourse. In this respect, the results of recent and ongoing clinical studies are expected with much interest. How valuable Femidom will prove to be, in terms of sexual health and contraception, will also depend largely on its long-term user-acceptability. As is generally the case with new methods, initial public interest in Femidom is expected to be high, as was documented in numerous surveys, and there undoubtedly exists a sub-group of women who view the product as their most appropriate contraceptive/sexually transmitted disease prevention option. However, more information on the product's acceptability, based on continuation rates, as is usually applied to other contraceptive techniques, is urgently needed to permit a more reliable assessment of Femidom's position among current methods. The arrival of a female condom represents a welcome addition to the range of female-controlled barrier contraceptives and, because of its numerous potential advantages over the male condom, may play an important role in the prevention of unwanted pregnancy and sexually transmitted diseases.

A global survey of HIV-positive people's attitudes towards cure research.

PubMed

Simmons, R; Kall, M; Collins, S; Cairns, G; Taylor, S; Nelson, M; Fidler, S; Porter, K; Fox, J

2017-02-01

Involvement of people living with HIV (PLHIV) in the design of HIV cure studies is important, given the potential risks to participants. We present results of an international survey of PLHIV to define these issues and inform cure research. PLHIV were recruited in June-November 2014 through HIV websites, advocacy forums, social media and 12 UK HIV clinics. The survey included questions concerning demographics, HIV disease history, the desirability of types of cure and the patient's willingness to accept potential toxicity and treatment interruption (TI). We examined factors associated with TI and willingness to accept substantial risks. A total of 982 PLHIV completed the survey; 87% were male, 79% white and 81% men who have sex with men (MSM). Fifty-one per cent were aged 25-44 years and 69% were UK residents. The median time since diagnosis was 7 years [interquartile range (IQR) 2-17 years]. Eighty-eight per cent were receiving antiretrovirals (91% reported undetectable viral load). Health/wellbeing improvements (96%) and an inability to transmit HIV (90%) were more desirable cure characteristics than testing HIV-negative (69%). Ninety-five per cent were interested in participating in cure studies, and 59% were willing to accept substantial risks. PLHIV with a low CD4 count [201-350 cells/μL vs. ≥ 350 cells/μL; odds ratio (OR) 2.11; 95% confidence interval (CI) 1.11-4.00] were more likely to accept risks, whereas those with limited knowledge of HIV treatments vs. excellent/good knowledge and those aged ≥ 65 years vs. 45-64 years were less likely to accept risks [OR 0.58 (95% CI 0.37-0.90) and OR 0.18 (95% CI 0.07-0.45), respectively]. TI was acceptable for 62% of participants, with the main concerns being becoming unwell (82%), becoming infectious (76%) and HIV spreading through the body (76%). Cure research was highly acceptable to the PLHIV surveyed. Most individuals would accept risks, including TI, even in the absence of personal benefit. An optimal cure would improve health and minimize onward transmission risk. © 2016 British HIV Association.

Early and mid-term results of autograft rescue by Ross reversal: A one-valve disease need not become a two-valve disease.

PubMed

Hussain, Syed T; Majdalany, David S; Dunn, Aaron; Stewart, Robert D; Najm, Hani K; Svensson, Lars G; Houghtaling, Penny L; Blackstone, Eugene H; Pettersson, Gösta B

2018-02-01

Risk of reoperation and loss of a second native valve are major drawbacks of the Ross operation. Rather than discarding the failed autograft, it can be placed back into the native pulmonary position by "Ross reversal." We review our early and mid-term results with this operation. From 2006 to 2017, 39 patients underwent reoperation for autograft dysfunction. The autograft was successfully rescued in 35 patients: by Ross reversal in 30, David procedure in 4, and autograft repair in 1. Medical records were reviewed for patient characteristics (mean age was 46 ± 13 years, range 18-67 years, and 23 were male), previous operations, indications for reoperation, hospital outcomes, and echocardiographic findings for the 30 patients undergoing successful Ross reversal. Follow-up was 4.1 ± 3.5 years (range 7 months-11 years). Median interval between the original Ross procedure and Ross reversal was 12 years (range 5-19 years). Eight patients also had absolute indications for replacement of the pulmonary allograft. There was no operative mortality. One patient required reoperation for bleeding. Another had an abdominal aorta injury from use of an endoballoon clamp. There was no other major postoperative morbidity, and median postoperative hospital stay was 7.2 days (range 4-41 days). No patient required reoperation during follow-up. Twenty-four patients had acceptable pulmonary valve function, and 6 had clinically well-tolerated moderate or severe pulmonary regurgitation. Ross reversal can be performed with low morbidity and acceptable pulmonary valve function, reducing patient risk of losing 2 native valves when the autograft fails in the aortic position. Copyright © 2017 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

Appropriate threshold levels of cardiac beat-to-beat variation in semi-automatic analysis of equine ECG recordings.

PubMed

Flethøj, Mette; Kanters, Jørgen K; Pedersen, Philip J; Haugaard, Maria M; Carstensen, Helena; Olsen, Lisbeth H; Buhl, Rikke

2016-11-28

Although premature beats are a matter of concern in horses, the interpretation of equine ECG recordings is complicated by a lack of standardized analysis criteria and a limited knowledge of the normal beat-to-beat variation of equine cardiac rhythm. The purpose of this study was to determine the appropriate threshold levels of maximum acceptable deviation of RR intervals in equine ECG analysis, and to evaluate a novel two-step timing algorithm by quantifying the frequency of arrhythmias in a cohort of healthy adult endurance horses. Beat-to-beat variation differed considerably with heart rate (HR), and an adaptable model consisting of three different HR ranges with separate threshold levels of maximum acceptable RR deviation was consequently defined. For resting HRs <60 beats/min (bpm) the threshold level of RR deviation was set at 20%, for HRs in the intermediate range between 60 and 100 bpm the threshold was 10%, and for exercising HRs >100 bpm, the threshold level was 4%. Supraventricular premature beats represented the most prevalent arrhythmia category with varying frequencies in seven horses at rest (median 7, range 2-86) and six horses during exercise (median 2, range 1-24). Beat-to-beat variation of equine cardiac rhythm varies according to HR, and threshold levels in equine ECG analysis should be adjusted accordingly. Standardization of the analysis criteria will enable comparisons of studies and follow-up examinations of patients. A small number of supraventricular premature beats appears to be a normal finding in endurance horses. Further studies are required to validate the findings and determine the clinical significance of premature beats in horses.

Clinically acceptable agreement between the ViMove wireless motion sensor system and the Vicon motion capture system when measuring lumbar region inclination motion in the sagittal and coronal planes.

PubMed

Mjøsund, Hanne Leirbekk; Boyle, Eleanor; Kjaer, Per; Mieritz, Rune Mygind; Skallgård, Tue; Kent, Peter

2017-03-21

Wireless, wearable, inertial motion sensor technology introduces new possibilities for monitoring spinal motion and pain in people during their daily activities of work, rest and play. There are many types of these wireless devices currently available but the precision in measurement and the magnitude of measurement error from such devices is often unknown. This study investigated the concurrent validity of one inertial motion sensor system (ViMove) for its ability to measure lumbar inclination motion, compared with the Vicon motion capture system. To mimic the variability of movement patterns in a clinical population, a sample of 34 people were included - 18 with low back pain and 16 without low back pain. ViMove sensors were attached to each participant's skin at spinal levels T12 and S2, and Vicon surface markers were attached to the ViMove sensors. Three repetitions of end-range flexion inclination, extension inclination and lateral flexion inclination to both sides while standing were measured by both systems concurrently with short rest periods in between. Measurement agreement through the whole movement range was analysed using a multilevel mixed-effects regression model to calculate the root mean squared errors and the limits of agreement were calculated using the Bland Altman method. We calculated root mean squared errors (standard deviation) of 1.82° (±1.00°) in flexion inclination, 0.71° (±0.34°) in extension inclination, 0.77° (±0.24°) in right lateral flexion inclination and 0.98° (±0.69°) in left lateral flexion inclination. 95% limits of agreement ranged between -3.86° and 4.69° in flexion inclination, -2.15° and 1.91° in extension inclination, -2.37° and 2.05° in right lateral flexion inclination and -3.11° and 2.96° in left lateral flexion inclination. We found a clinically acceptable level of agreement between these two methods for measuring standing lumbar inclination motion in these two cardinal movement planes. Further research should investigate the ViMove system's ability to measure lumbar motion in more complex 3D functional movements and to measure changes of movement patterns related to treatment effects.

A pilot study to understand feasibility and acceptability of stool and cord blood sample collection for a large-scale longitudinal birth cohort.

PubMed

Bailey, S R; Townsend, C L; Dent, H; Mallet, C; Tsaliki, E; Riley, E M; Noursadeghi, M; Lawley, T D; Rodger, A J; Brocklehurst, P; Field, N

2017-12-28

Few data are available to guide biological sample collection around the time of birth for large-scale birth cohorts. We are designing a large UK birth cohort to investigate the role of infection and the developing immune system in determining future health and disease. We undertook a pilot to develop methodology for the main study, gain practical experience of collecting samples, and understand the acceptability of sample collection to women in late pregnancy. Between February-July 2014, we piloted the feasibility and acceptability of collecting maternal stool, baby stool and cord blood samples from participants recruited at prolonged pregnancy and planned pre-labour caesarean section clinics at University College London Hospital. Participating women were asked to complete acceptability questionnaires. Overall, 265 women were approached and 171 (65%) participated, with ≥1 sample collected from 113 women or their baby (66%). Women had a mean age of 34 years, were primarily of white ethnicity (130/166, 78%), and half were nulliparous (86/169, 51%). Women undergoing planned pre-labour caesarean section were more likely than those who delivered vaginally to provide ≥1 sample (98% vs 54%), but less likely to provide maternal stool (10% vs 43%). Pre-sample questionnaires were completed by 110/171 women (64%). Most women reported feeling comfortable with samples being collected from their baby (<10% uncomfortable), but were less comfortable about their own stool (19% uncomfortable) or a vaginal swab (24% uncomfortable). It is possible to collect a range of biological samples from women around the time of delivery, and this was acceptable for most women. These data inform study design and protocol development for large-scale birth cohorts.

WE-E-204-02: Journal of Medical Physics and JACMP

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

Williamson, J.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

WE-E-204-00: Where to Send My Manuscript

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

NONE

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

WE-E-204-01: ASTRO Based Journals

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

Klein, E.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

TU-B-16A-01: To Which Journal Should I Submit My Paper

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

Williamson, J; Mills, M; Klein, E

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given the large number (about 100) competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose ofmore » this symposium is to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. The senior editors for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase chances of acceptance To help decipher which journal is appropriate for a given work.« less

WE-E-204-03: Radiology and Other Imaging Journals

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

Karellas, A.

Research papers authored by Medical Physicists address a large spectrum of oncologic, imaging, or basic research problems; exploit a wide range of physical and engineering methodologies; and often describe the efforts of a multidisciplinary research team. Given dozens of competing journals accepting medical physics articles, it may not be clear to an individual author which journal is the best venue for disseminating their work to the scientific community. Relevant factors usually include the Journal’s audience and scientific impact, but also such factors as perceived acceptance rate, interest in their topic, and quality of service. The purpose of this symposium ismore » to provide the medical physics community with an overview of scope, review processes, and article guidelines for the following journals: Radiology, Medical Physics, International Journal of Radiation Biology and Physics, Journal of Applied Clinical Medical Physics, and Practical Radiation Oncology. Senior members of the editorial board for each journal will provide details as to the journals review process, for example: single blind versus double blind reviews; open access policies, the hierarchy of the review process in terms of editorial board structure; the reality of acceptance, in terms of acceptance rate; and the types of research the journal prefers to publish. Other journals will be discussed as well. The goal is to provide for authors guidance before they begin to write their papers, not only for proper formatting, but also that the readership is appropriate for the particular paper, hopefully increasing the quality and impact of the paper and the likelihood of publication. Learning Objectives: To review each Journal’s submission and review process Guidance as to how to increase quality, impact and chances of acceptance To help decipher which journal is appropriate for a given work A. Karellas, Research collaboration with Koning, Corporation.« less

Experimental fusion of different versions of the total laboratory automation system and improvement of laboratory turnaround time.

PubMed

Chung, Hee-Jung; Song, Yoon Kyung; Hwang, Sang-Hyun; Lee, Do Hoon; Sugiura, Tetsuro

2018-02-25

Use of total laboratory automation (TLA) system has expanded to microbiology and hemostasis and upgraded to second and third generations. We herein report the first successful upgrades and fusion of different versions of the TLA system, thus improving laboratory turnaround time (TAT). A 21-day schedule was planned from the time of pre-meeting to installation and clinical sample application. We analyzed the monthly TAT in each menu, distribution of the "out of range for acceptable TAT" samples, and "prolonged time out of acceptable TAT," before and after the upgrade and fusion. We installed and customized hardware, middleware, and software. The one-way CliniLog 2.0 version track, 50.0-m long, was changed to a 23.2-m long one-way 2.0 version and an 18.7-m long two-way 4.0 version. The monthly TAT in the outpatient samples, before and after upgrading the TLA system, were uniformly satisfactory in the chemistry and viral marker menus. However, in the tumor marker menu, the target TAT (98.0% of samples ≤60 minutes) was not satisfied during the familiarization period. There was no significant difference in the proportion of "out of acceptable TAT" samples, before and after the TLA system upgrades (7.4‰ and 8.5‰). However, the mean "prolonged time out of acceptable TAT" in the chemistry samples was significantly shortened to 17.4 (±24.0) minutes after the fusion, from 34.5 (±43.4) minutes. Despite experimental challenges, a fusion of the TLA system shortened the "prolonged time out of acceptable TAT," indicating a distribution change in overall TAT. © 2018 Wiley Periodicals, Inc.

Surrogate outcomes: experiences at the Common Drug Review

PubMed Central

2013-01-01

Background Surrogate outcomes are a significant challenge in drug evaluation for health technology assessment (HTA) agencies. The research objectives were to: identify factors associated with surrogate use and acceptability in Canada’s Common Drug Review (CDR) recommendations, and compare the CDR with other HTA or regulatory agencies regarding surrogate concerns. Methods Final recommendations were identified from CDR inception (September 2003) to December 31, 2010. Recommendations were classified by type of outcome (surrogate, final, other) and acceptability of surrogates (determined by the presence/absence of statements of concern regarding surrogates). Descriptive and statistical analyses examined factors related to surrogate use and acceptability. For thirteen surrogate-based submissions, recommendations from international HTA and regulatory agencies were reviewed for statements about surrogate acceptability. Results Of 156 final recommendations, 68 (44%) involved surrogates. The overall ‘do not list’ (DNL) rate was 48%; the DNL rate for surrogates was 41% (p = 0.175). The DNL rate was 64% for non-accepted surrogates (n = 28) versus 25% for accepted surrogates (odds ratio 5.4, p = 0.002). Clinical uncertainty, use of economic evidence over price alone, and a premium price were significantly associated with non-accepted surrogates. Surrogates were used most commonly for HIV, diabetes, rare diseases, cardiovascular disease and cancer. For the subset of drugs studied, other HTA agencies did not express concerns for most recommendations, while regulatory agencies frequently stated surrogate acceptance. Conclusions The majority of surrogates were accepted at the CDR. Non-accepted surrogates were significantly associated with clinical uncertainty and a DNL recommendation. There was inconsistency of surrogate acceptability across several international agencies. Stakeholders should consider collaboratively establishing guidelines on the use, validation, and acceptability of surrogates. PMID:24341379

Communicating in context: a priority for gene therapy researchers.

PubMed

Robillard, Julie M

2015-03-01

History shows that public opinion of emerging biotechnologies has the potential to impact the research process through mechanisms such as funding and advocacy. It is critical, therefore, to consider public attitudes towards modern biotechnology such as gene therapy and more specifically towards the ethics of gene therapy, alongside advances in basic and clinical research. Research conducted through social media recently assessed how online users view the ethics of gene therapy and showed that while acceptability is high, significant ethical concerns remain. To address these concerns, the development of effective and evidence-based communication strategies that engage a wide range of stakeholders should be a priority for researchers.

The politics of nursing: a case study--clinical grading.

PubMed

Gavin, J N

1995-08-01

This paper is a study of the clinical grading policy for nurses in the United Kingdom and the extent to which the participating groups in the policy development process realized their objectives. The study is based on the literature available at the time of the research and the results of structured interviews with a range of individuals involved in the policy process. The results expose the cleavages between the different representative groups on the staff side. They also shed light on the differing power bases of the groups involved. In particular, they expose the weakness of nursing as a professional pressure group and the strength of the state and its agents in determining the outcomes of policy in the public arena. It is suggested that this weakness vis-à-vis the state is responsible for the failure of nurses to achieve a reward system which recognizes the value of clinical nursing expertise, and that the 'clinical grading' system, in practice, is having the opposite effect. The policy is explored from its origins, its acceptance on to the political agenda, its negotiation and agreement, its contentious implementation, the final outcomes, and its failure to establish a valid 'clinical' pay structure.

Assessing performance of closed-loop insulin delivery systems by continuous glucose monitoring: drawbacks and way forward.

PubMed

Hovorka, Roman; Nodale, Marianna; Haidar, Ahmad; Wilinska, Malgorzata E

2013-01-01

We investigated whether continuous glucose monitoring (CGM) levels can accurately assess glycemic control while directing closed-loop insulin delivery. Data were analyzed retrospectively from 33 subjects with type 1 diabetes who underwent closed-loop and conventional pump therapy on two separate nights. Glycemic control was evaluated by reference plasma glucose and contrasted against three methods based on Navigator (Abbott Diabetes Care, Alameda, CA) CGM levels. Glucose mean and variability were estimated by unmodified CGM levels with acceptable clinical accuracy. Time when glucose was in target range was overestimated by CGM during closed-loop nights (CGM vs. plasma glucose median [interquartile range], 86% [65-97%] vs. 75% [59-91%]; P=0.04) but not during conventional pump therapy (57% [32-72%] vs. 51% [29-68%]; P=0.82) providing comparable treatment effect (mean [SD], 28% [29%] vs. 23% [21%]; P=0.11). Using the CGM measurement error of 15% derived from plasma glucose-CGM pairs (n=4,254), stochastic interpretation of CGM gave unbiased estimate of time in target during both closed-loop (79% [62-86%] vs. 75% [59-91%]; P=0.24) and conventional pump therapy (54% [33-66%] vs. 51% [29-68%]; P=0.44). Treatment effect (23% [24%] vs. 23% [21%]; P=0.96) and time below target were accurately estimated by stochastic CGM. Recalibrating CGM using reference plasma glucose values taken at the start and end of overnight closed-loop was not superior to stochastic CGM. CGM is acceptable to estimate glucose mean and variability, but without adjustment it may overestimate benefit of closed-loop. Stochastic CGM provided unbiased estimate of time when glucose is in target and below target and may be acceptable for assessment of closed-loop in the outpatient setting.

Second trimester medical abortion with mifepristone followed by unlimited dosing of buccal misoprostol in Armenia.

PubMed

Louie, Karmen S; Chong, Erica; Tsereteli, Tamar; Avagyan, Gayane; Abrahamyan, Ruzanna; Winikoff, Beverly

2017-02-01

The aim of the study was to assess the efficacy and acceptability of a regimen using mifepristone and buccal misoprostol with unlimited dosing for second trimester abortion in Armenia. Women seeking to terminate 13-22 week pregnancies were enrolled in the study. Participants swallowed 200 mg mifepristone in the clinic and were instructed to return to the hospital for induction 24-48 h later. During induction, women were given 400 μg buccal misoprostol every 3 h until the fetus and placenta were expelled. The abortion was considered a success if complete uterine evacuation was achieved without oxytocin or surgery. A total of 120 women with a median gestational age of 18 weeks participated in the study. All women began misoprostol induction around 24 h after taking mifepristone. Complete uterine evacuation was achieved in 119 (99.2%) women. The median induction-to-abortion interval was 10.3 h (range 4-17.4) with a mean of 9.5 ± 2.5 h. A median of four misoprostol doses (range 2-6) with a mean of 4 ± 1 misoprostol doses were administered. The induction-to-abortion interval, number of misoprostol doses, pain score and analgesia use increased as gestational age advanced. Acceptability of the method was high among both patients and providers. The medical abortion regimen of 200 mg mifepristone followed 24 h later by induction with 400 μg buccal misoprostol administered every 3 h, with no limit on the number of doses used for the termination of pregnancies of 13-22 weeks' gestation is an effective and acceptable option for women.

Prospective Evaluation Of Cervico-Vaginal Self And Cervical Physician-Collection For The Detection Of Chlamydia Trachomatis, Neisseria Gonorrhoeae, Trichomonas Vaginalis, And Mycoplasma Genitalium Infections.

PubMed

Lockhart, Alexandre; Psioda, Matt; Ting, Jie; Campbell, Sara; Mugo, Nelly; Kwatampora, Jessie; Chitwa, Michael; Kimani, Joshua; Gakure, Anne; Smith, Jennifer S

2018-01-02

To examine the agreement between sexually transmitted infection (STI) screening using self-collected specimens and physician-collected specimens, and to investigate the acceptability of self-collection for screening in an 18-month study of female sex-workers (FSW) in a high-risk, low-resource setting. A total of 350 FSW in Nairobi, Kenya participated in a prospective study from 2009-2011. Women self-collected a cervico-vaginal specimen. Next, a physician conducted a pelvic examination to obtain a cervical specimen. Physician- and self-collected specimens were tested for Chlamydia trachomatis (CT), Neisseria gonorrhoeae (GC), Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) using Aptima nucleic acid amplification assays (Hologic). Specimens were collected at three-month intervals over 18-months follow-up. Kappa statistics measured agreement of positivity between self- and physician-collection. Baseline STI prevalence was 2.9% for GC, 5.2% for CT, 9.2% for TV, and 20.1% for MG in self-collected samples, and 2.3%, 3.7%, 7.2%, and 12.9% respectively in physician-collected samples. Kappa agreement was consistently strong (range 0.66-1.00) for all STIs over the 18-month study period, except MG which had moderate agreement (range: 0.50-0.75). Most participants found self-collection easy (94%) and comfortable (89%) at baseline, with responses becoming modestly more favorable over time. Self-collected specimens screening results showed strong agreement to clinical-collected specimens, except MG which was consistently detected more commonly in self- than physician-collected specimens. Acceptability of the self-collection procedure was high at baseline and increased modestly over time. In high-risk, low-resource settings, STI screening with self-collected specimens provides a reliable and acceptable alternative to screening with physician-collected specimens.

Interexaminer reliability in physical examination of patients with low back pain.

PubMed

Strender, L E; Sjöblom, A; Sundell, K; Ludwig, R; Taube, A

1997-04-01

Seventy-one patients with low back pain were examined by two physiotherapists (50 patients) and two physicians (21 patients). The two physiotherapists had worked together for many years, but the two physicians had not. The interexaminer reliability of the clinical tests included in the physical examination was evaluated. To evaluate the interexaminer reliability of clinical tests used in the physical examination of patients with low back pain under ideal circumstances, which was the case for the physiotherapists. Numerous clinical tests are used in the evaluation of patients with low back pain. To reach the correct diagnosis, only tests with an acceptable validity and reliability should be used. Previous studies have mainly shown low reliability. It is important that clinical tests not be rejected because of low reliability caused by differences between examiners in performance of the examination and in their definition of normal results. Two examiners, either two physiotherapists or two physicians, independently examined patients with low back pain. In approximately half of the clinical tests studied, an acceptable reliability was demonstrated. On the basis of the physiotherapists series, the reliability was acceptable for a number of clinical tests that are used in the evaluation of patients with low back pain. The results suggest that clinical tests should be standardized to a much higher degree than they are today.

Parental Attitudes About Placebo Use in Children.

PubMed

Faria, Vanda; Kossowsky, Joe; Petkov, Mike P; Kaptchuk, Ted J; Kirsch, Irving; Lebel, Alyssa; Borsook, David

2017-02-01

To assess parental attitudes regarding placebo use in pediatric randomized controlled trials and clinical care. Parents with children under age 18 years living in the US completed and submitted an online survey between September and November 2014. Among all 1300 participants, 1000 (76.9%; 538 mothers and 462 fathers) met the study inclusion criteria. The majority of surveyed parents considered the use of placebos acceptable in some pediatric care situations (86%) and some pediatric trials (91.5%), whereas only 5.7% of parents found the use of placebos in children always unacceptable. The clinical use of placebo was considered acceptable by a majority of parents for only 7 (mostly psychological) of the 17 conditions presented. Respondents' judgment about acceptability was influenced by the doctors' opinions about the therapeutic benefits of placebo treatment, the conditions for pediatric placebo use, transparency, safety, and purity of placebos. Most surveyed parents accepted the idea of using placebos in pediatric trials and within the clinic for some conditions without the practice of deception and with the creation of guidelines for ethical and safe use. This study suggests a need to reconsider pediatric trial design and clinical therapy in the light of generally positive parental support of appropriate placebo use. Copyright © 2016 Elsevier Inc. All rights reserved.

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal

PubMed Central

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M. Juliana; Hural, John

2014-01-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×106 ±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8–3.2×106 cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%–130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. PMID:24709391

The Feasibility and Acceptability to Service Users of CIRCuiTS, a Computerized Cognitive Remediation Therapy Programme for Schizophrenia.

PubMed

Reeder, Clare; Pile, Victoria; Crawford, Polly; Cella, Matteo; Rose, Diana; Wykes, Til; Watson, Andrew; Huddy, Vyv; Callard, Felicity

2016-05-01

Cognitive remediation (CR) is a psychological therapy, effective in improving cognitive performance and functioning in people with schizophrenia. As the therapy becomes more widely implemented within mental health services its longevity and uptake is likely to depend on its feasibility and acceptability to service users and clinicians. To assess the feasibility and acceptability of a new strategy-based computerized CR programme (CIRCuiTS) for people with psychosis. Four studies were conducted using mixed methods. Perceptions of attractiveness, comprehensibility, acceptability and usability were assessed using self-report questionnaires in 34 non-clinical participants (study 1), and five people with a schizophrenia diagnosis and three experienced CR therapists (studies 2 and 3). The ease with which pre-specified therapy programmes could be assembled was also assessed by three therapists (Study 2). Finally, the satisfaction of 20 service users with a diagnosis of schizophrenia regarding their experience of using CIRCuiTS in the context of a course of the CR therapy was assessed in a qualitative interview study (study 4). Ratings of perceived attractiveness, comprehensibility, acceptability and usability consistently exceeded pre-set high targets by non-clinical, clinical and therapist participants. Qualitative analysis of satisfaction with CIRCuiTS showed that receiving the therapy was generally seen to be a positive experience, leading to perceptions that cognitive functioning had improved and attempts to incorporate new strategy use into daily activities. CIRCuiTS demonstrates high acceptability and ease of use for both service users with a schizophrenia diagnosis and clinicians.

The Use of Acceptance to Promote Positive Change by Decreasing Shame and Guilt: A Practice Exemplar.

PubMed

Meltzer, Mary-Ellen

2015-01-01

The use of acceptance by mental health clinicians in the clinical setting is an effective method for providing a safe environment for clients to make positive changes. Acceptance means that mental health clinicians are non-judgmental and acknowledge the clients' situations as they are. When actively used by clinicians, acceptance decreases clients' anxiety and the intensity of their feelings of guilt and shame. Clients are then able to begin to accept themselves as they are. The purpose of this article is to discuss the ways in which mental health clinicians promote clients' acceptance of themselves using the tools of acceptance and commitment therapy and dialectical behavioral therapy.

Randomized Clinical Trial of Cognitive Behavioral Therapy (CBT) versus Acceptance and Commitment Therapy (ACT) for Mixed Anxiety Disorders

ERIC Educational Resources Information Center

Arch, Joanna J.; Eifert, Georg H.; Davies, Carolyn; Vilardaga, Jennifer C. Plumb; Rose, Raphael D.; Craske, Michelle G.

2012-01-01

Objective: Randomized comparisons of acceptance-based treatments with traditional cognitive behavioral therapy (CBT) for anxiety disorders are lacking. To address this gap, we compared acceptance and commitment therapy (ACT) to CBT for heterogeneous anxiety disorders. Method: One hundred twenty-eight individuals (52% female, mean age = 38, 33%…

Comparative effectiveness, safety and acceptability of medical abortion at home and in a clinic: a systematic review

PubMed Central

Park, Min Hae; Shakur, Haleema; Free, Caroline

2011-01-01

Abstract Objective To compare medical abortion practised at home and in clinics in terms of effectiveness, safety and acceptability. Methods A systematic search for randomized controlled trials and prospective cohort studies comparing home-based and clinic-based medical abortion was conducted. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE and Popline were searched. Failure to abort completely, side-effects and acceptability were the main outcomes of interest. Odds ratios and their 95% confidence intervals (CIs) were calculated. Estimates were pooled using a random-effects model. Findings Nine studies met the inclusion criteria (n = 4522 participants). All were prospective cohort studies that used mifepristone and misoprostol to induce abortion. Complete abortion was achieved by 86–97% of the women who underwent home-based abortion (n = 3478) and by 80–99% of those who underwent clinic-based abortion (n = 1044). Pooled analyses from all studies revealed no difference in complete abortion rates between groups (odds ratio = 0.8; 95% CI: 0.5–1.5). Serious complications from abortion were rare. Pain and vomiting lasted 0.3 days longer among women who took misoprostol at home rather than in clinic. Women who chose home-based medical abortion were more likely to be satisfied, to choose the method again and to recommend it to a friend than women who opted for medical abortion in a clinic. Conclusion Home-based abortion is safe under the conditions in place in the included studies. Prospective cohort studies have shown no differences in effectiveness or acceptability between home-based and clinic-based medical abortion across countries. PMID:21556304

Utilizing knowledge from prior plans in the evaluation of quality assurance

NASA Astrophysics Data System (ADS)

Stanhope, Carl; Wu, Q. Jackie; Yuan, Lulin; Liu, Jianfei; Hood, Rodney; Yin, Fang-Fang; Adamson, Justus

2015-06-01

Increased interest regarding sensitivity of pre-treatment intensity modulated radiotherapy and volumetric modulated arc radiotherapy (VMAT) quality assurance (QA) to delivery errors has led to the development of dose-volume histogram (DVH) based analysis. This paradigm shift necessitates a change in the acceptance criteria and action tolerance for QA. Here we present a knowledge based technique to objectively quantify degradations in DVH for prostate radiotherapy. Using machine learning, organ-at-risk (OAR) DVHs from a population of 198 prior patients’ plans were adapted to a test patient’s anatomy to establish patient-specific DVH ranges. This technique was applied to single arc prostate VMAT plans to evaluate various simulated delivery errors: systematic single leaf offsets, systematic leaf bank offsets, random normally distributed leaf fluctuations, systematic lag in gantry angle of the mutli-leaf collimators (MLCs), fluctuations in dose rate, and delivery of each VMAT arc with a constant rather than variable dose rate. Quantitative Analyses of Normal Tissue Effects in the Clinic suggests V75Gy dose limits of 15% for the rectum and 25% for the bladder, however the knowledge based constraints were more stringent: 8.48   ±   2.65% for the rectum and 4.90   ±   1.98% for the bladder. 19   ±   10 mm single leaf and 1.9   ±   0.7 mm single bank offsets resulted in rectum DVHs worse than 97.7% (2σ) of clinically accepted plans. PTV degradations fell outside of the acceptable range for 0.6   ±   0.3 mm leaf offsets, 0.11   ±   0.06 mm bank offsets, 0.6   ±   1.3 mm of random noise, and 1.0   ±   0.7° of gantry-MLC lag. Utilizing a training set comprised of prior treatment plans, machine learning is used to predict a range of achievable DVHs for the test patient’s anatomy. Consequently, degradations leading to statistical outliers may be identified. A knowledge based QA evaluation enables customized QA criteria per treatment site, institution and/or physician and can often be more sensitive to errors than criteria based on organ complication rates.

The Ling 6(HL) test: typical pediatric performance data and clinical use evaluation.

PubMed

Glista, Danielle; Scollie, Susan; Moodie, Sheila; Easwar, Vijayalakshmi

2014-01-01

The Ling 6(HL) test offers a calibrated version of naturally produced speech sounds in dB HL for evaluation of detection thresholds. Aided performance has been previously characterized in adults. The purpose of this work was to evaluate and refine the Ling 6(HL) test for use in pediatric hearing aid outcome measurement. This work is presented across two studies incorporating an integrated knowledge translation approach in the characterization of normative and typical performance, and in the evaluation of clinical feasibility, utility, acceptability, and implementation. A total of 57 children, 28 normally hearing and 29 with binaural sensorineural hearing loss, were included in Study 1. Children wore their own hearing aids fitted using Desired Sensation Level v5.0. Nine clinicians from The Network of Pediatric Audiologists participated in Study 2. A CD-based test format was used in the collection of unaided and aided detection thresholds in laboratory and clinical settings; thresholds were measured clinically as part of routine clinical care. Confidence intervals were derived to characterize normal performance and typical aided performance according to hearing loss severity. Unaided-aided performance was analyzed using a repeated-measures analysis of variance. The audiologists completed an online questionnaire evaluating the quality, feasibility/executability, utility/comparative value/relative advantage, acceptability/applicability, and interpretability, in addition to recommendation and general comments sections. Ling 6(HL) thresholds were reliably measured with children 3-18 yr old. Normative and typical performance ranges were translated into a scoring tool for use in pediatric outcome measurement. In general, questionnaire respondents generally agreed that the Ling 6(HL) test was a high-quality outcome evaluation tool that can be implemented successfully in clinical settings. By actively collaborating with pediatric audiologists and using an integrated knowledge translation framework, this work supported the creation of an evidence-based clinical tool that has the potential to be implemented in, and useful to, clinical practice. More research is needed to characterize performance in alternative listening conditions to facilitate use with infants, for example. Future efforts focused on monitoring the use of the Ling 6(HL) test in daily clinical practice may help describe whether clinical use has been maintained across time and if any additional adaptations are necessary to facilitate clinical uptake. American Academy of Audiology.

Adaptation of the CVT algorithm for catheter optimization in high dose rate brachytherapy

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

Poulin, Eric; Fekete, Charles-Antoine Collins; Beaulieu, Luc

2013-11-15

Purpose: An innovative, simple, and fast method to optimize the number and position of catheters is presented for prostate and breast high dose rate (HDR) brachytherapy, both for arbitrary templates or template-free implants (such as robotic templates).Methods: Eight clinical cases were chosen randomly from a bank of patients, previously treated in our clinic to test our method. The 2D Centroidal Voronoi Tessellations (CVT) algorithm was adapted to distribute catheters uniformly in space, within the maximum external contour of the planning target volume. The catheters optimization procedure includes the inverse planning simulated annealing algorithm (IPSA). Complete treatment plans can then bemore » generated from the algorithm for different number of catheters. The best plan is chosen from different dosimetry criteria and will automatically provide the number of catheters and their positions. After the CVT algorithm parameters were optimized for speed and dosimetric results, it was validated against prostate clinical cases, using clinically relevant dose parameters. The robustness to implantation error was also evaluated. Finally, the efficiency of the method was tested in breast interstitial HDR brachytherapy cases.Results: The effect of the number and locations of the catheters on prostate cancer patients was studied. Treatment plans with a better or equivalent dose distributions could be obtained with fewer catheters. A better or equal prostate V100 was obtained down to 12 catheters. Plans with nine or less catheters would not be clinically acceptable in terms of prostate V100 and D90. Implantation errors up to 3 mm were acceptable since no statistical difference was found when compared to 0 mm error (p > 0.05). No significant difference in dosimetric indices was observed for the different combination of parameters within the CVT algorithm. A linear relation was found between the number of random points and the optimization time of the CVT algorithm. Because the computation time decrease with the number of points and that no effects were observed on the dosimetric indices when varying the number of sampling points and the number of iterations, they were respectively fixed to 2500 and to 100. The computation time to obtain ten complete treatments plans ranging from 9 to 18 catheters, with the corresponding dosimetric indices, was 90 s. However, 93% of the computation time is used by a research version of IPSA. For the breast, on average, the Radiation Therapy Oncology Group recommendations would be satisfied down to 12 catheters. Plans with nine or less catheters would not be clinically acceptable in terms of V100, dose homogeneity index, and D90.Conclusions: The authors have devised a simple, fast and efficient method to optimize the number and position of catheters in interstitial HDR brachytherapy. The method was shown to be robust for both prostate and breast HDR brachytherapy. More importantly, the computation time of the algorithm is acceptable for clinical use. Ultimately, this catheter optimization algorithm could be coupled with a 3D ultrasound system to allow real-time guidance and planning in HDR brachytherapy.« less

Appraising the methodological quality of the clinical practice guideline for diabetes mellitus using the AGREE II instrument: a methodological evaluation.

PubMed

Radwan, Mahmoud; Akbari Sari, Ali; Rashidian, Arash; Takian, Amirhossein; Abou-Dagga, Sanaa; Elsous, Aymen

2017-02-01

To evaluate the methodological quality of the Palestinian Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological evaluation. A cross-cultural adaptation framework was followed to translate and develop a standardised Translated Arabic Version of the AGREE II. Palestinian Primary Healthcare Centres. Sixteen appraisers independently evaluated the Clinical Practice Guideline for Diabetes Mellitus using the Translated Arabic Version of the AGREE II. Methodological quality of diabetic guideline. The Translated Arabic Version of the AGREE II showed an acceptable reliability and validity. Internal consistency ranged between 0.67 and 0.88 (Cronbach's α). Intra-class coefficient among appraisers ranged between 0.56 and 0.88. The quality of this guideline is low. Both domains 'Scope and Purpose' and 'Clarity of Presentation' had the highest quality scores (66.7% and 61.5%, respectively), whereas the scores for 'Applicability', 'Stakeholder Involvement', 'Rigour of Development' and 'Editorial Independence' were the lowest (27%, 35%, 36.5%, and 40%, respectively). The findings suggest that the quality of this Clinical Practice Guideline is disappointingly low. To improve the quality of current and future guidelines, the AGREE II instrument is extremely recommended to be incorporated as a gold standard for developing, evaluating or updating the Palestinian Clinical Practice Guidelines. Future guidelines can be improved by setting specific strategies to overcome implementation barriers with respect to economic considerations, engaging of all relevant end-users and patients, ensuring a rigorous methodology for searching, selecting and synthesising the evidences and recommendations, and addressing potential conflict of interests within the development group.

Traceability Assessment and Performance Evaluation of Results for Measurement of Abbott Clinical Chemistry Assays on 4 Chemistry Analyzers.

PubMed

Lim, Jinsook; Song, Kyung Eun; Song, Sang Hoon; Choi, Hyun-Jung; Koo, Sun Hoe; Kwon, Gye Choel

2016-05-01

-The traceability of clinical results to internationally recognized and accepted reference materials and reference measurement procedures has become increasingly important. Therefore, the establishment of traceability has become a mandatory requirement for all in vitro diagnostics devices. -To evaluate the traceability of the Abbott Architect c8000 system (Abbott Laboratories, Abbott Park, Illinois), consisting of calibrators and reagents, across 4 different chemistry analyzers, and to evaluate its general performance on the Toshiba 2000FR NEO (Toshiba Medical Systems Corporation, Otawara-shi, Tochigi-ken, Japan). -For assessment of traceability, secondary reference materials were evaluated 5 times, and then bias was calculated. Precision, linearity, and carryover were determined according to the guidelines of the Clinical and Laboratory Standards Institute (Wayne, Pennsylvania). -The biases from 4 different analyzers ranged from -2.33% to 2.70% on the Toshiba 2000FR NEO, -2.33% to 5.12% on the Roche Hitachi 7600 (Roche Diagnostics International, Basel, Switzerland), -0.93% to 2.87% on the Roche Modular, and -2.16% to 2.86% on the Abbott Architect c16000. The total coefficients of variance of all analytes were less than 5%. The coefficients of determination (R(2)) were more than 0.9900. The carryover rate ranged from -0.54% to 0.17%. -Abbott clinical chemistry assays met the performance criteria based on desirable biological variation for precision, bias, and total error. They also showed excellent linearity and carryover. Therefore, these clinical chemistry assays were found to be accurate and reliable and are readily applicable on the various platforms used in this study.

A randomized matched-pairs study of feasibility, acceptability, and effectiveness of systems consultation: a novel implementation strategy for adopting clinical guidelines for Opioid prescribing in primary care.

PubMed

Quanbeck, Andrew; Brown, Randall T; Zgierska, Aleksandra E; Jacobson, Nora; Robinson, James M; Johnson, Roberta A; Deyo, Brienna M; Madden, Lynn; Tuan, Wen-Jan; Alagoz, Esra

2018-01-25

This paper reports on the feasibility, acceptability, and effectiveness of an innovative implementation strategy named "systems consultation" aimed at improving adherence to clinical guidelines for opioid prescribing in primary care. While clinical guidelines for opioid prescribing have been developed, they have not been widely implemented, even as opioid abuse reaches epidemic levels. We tested a blended implementation strategy consisting of several discrete implementation strategies, including audit and feedback, academic detailing, and external facilitation. The study compares four intervention clinics to four control clinics in a randomized matched-pairs design. Each systems consultant aided clinics on implementing the guidelines during a 6-month intervention consisting of monthly site visits and teleconferences/videoconferences. The mixed-methods evaluation employs the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. Quantitative outcomes are compared using time series analysis. Qualitative methods included focus groups, structured interviews, and ethnographic field techniques. Seven clinics were randomly approached to recruit four intervention clinics. Each clinic designated a project team consisting of six to eight staff members, each with at least one prescriber. Attendance at intervention meetings was 83%. More than 80% of staff respondents agreed or strongly agreed with the statements: "I am more familiar with guidelines for safe opioid prescribing" and "My clinic's workflow for opioid prescribing is easier." At 6 months, statistically significant improvements were noted in intervention clinics in the percentage of patients with mental health screens, treatment agreements, urine drug tests, and opioid-benzodiazepine co-prescribing. At 12 months, morphine-equivalent daily dose was significantly reduced in intervention clinics compared to controls. The cost to deliver the strategy was $7345 per clinic. Adaptations were required to make the strategy more acceptable for primary care. Qualitatively, intervention clinics reported that chronic pain was now treated using approaches similar to those employed for other chronic conditions, such as hypertension and diabetes. The systems consultation implementation strategy demonstrated feasibility, acceptability, and effectiveness in a study involving eight primary care clinics. This multi-disciplinary strategy holds potential to mitigate the prevalence of opioid addiction and ultimately may help to improve implementation of clinical guidelines across healthcare. ClinicalTrials.gov (NCT02433496). https://clinicaltrials.gov/ct2/show/NCT02433496 Registered May 5, 2015.

“Caregiver Acceptability and Preferences for Early Childhood Caries Preventive Treatments for Hispanic Children”

PubMed Central

Adams, Sally H.; Hyde, Susan; Gansky, Stuart A.

2011-01-01

Objective Determine caregiver treatment acceptability and preferences for five preventive dental treatments for early childhood caries (ECC) in young Hispanic children. Methods We interviewed 211 parents/caregivers of Hispanic children attending Head Start programs regarding their acceptability of and preferences for five standard preventive dental treatments for young children. Treatments assessed were: toothbrushing with fluoride toothpaste, fluoride varnish, xylitol in food for children; and xylitol gum and chlorhexidine rinse for mothers. The interview assessment included presentation of: illustrated cards with verbal description of treatment; picture/video clip; and treatment samples. Parents rated the acceptability of each treatment (1-5 scale) and treatment preferences within each of 10 possible pairs. Individual treatment preferences were summed to create overall preference scores (range 0–4). Results All treatments were rated as highly acceptable, however there were differences (range 4.6-4.9; Friedman Chi Square = 23.4, p< 0.001). Chlorhexidine, toothbrushing, and varnish were most acceptable, not different from each other, but more acceptable than xylitol in food (p< 0.05). Summed treatment preferences revealed greater variability (means ranged 1.4-2.6; Friedman Chi Square=128.2, p< 0.001). Fluoride varnish (2.6) and toothbrushing (2.5) were most highly preferred, and differences between preferences for xylitol in food (1.4), xylitol gum (1.5) and chlorhexidine (2.1) were all significant, p < 0.001. Preferences for chlorhexidine were also significantly greater than those for the xylitol products (p < 0.001). Conclusions All 5 treatments were highly acceptable, however when choosing among treatments overall, fluoride varnish and toothbrushing were favored over other treatments. PMID:19486461

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

PubMed Central

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

2015-01-01

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

The SF36 health survey questionnaire: an outcome measure suitable for routine use within the NHS?

PubMed Central

Garratt, A M; Ruta, D A; Abdalla, M I; Buckingham, J K; Russell, I T

1993-01-01

OBJECTIVE--To assess the validity, reliability, and acceptability of the short form 36 (SF 36) health survey questionnaire (a shortened version of a battery of 149 health status questions) as a measure of patient outcome in a broad sample of patients suffering from four common clinical conditions. DESIGN--Postal questionnaire, followed up by two reminders at two week intervals. SETTING--Clinics and four training practices in north east Scotland. SUBJECTS--Over 1700 patients aged 16-86 with one of four conditions--low back pain, menorrhagia, suspected peptic ulcer, or varicose veins--and a comparison sample of 900 members of the general population. MAIN OUTCOME MEASURES--The eight scales within the SF36 health profile. RESULTS--The response rate exceeded 75% in the patient population (1310 respondents). The SF36 satisfied rigorous psychometric criteria for validity and internal consistency. Clinical validity was shown by the distinctive profiles generated for each condition, each of which differed from that in the general population in a predictable manner. Furthermore, SF36 scores were lower in referred patients than in patients not referred and were closely related to general practitioners' perceptions of severity. CONCLUSIONS--These results provide support for the SF36 as a potential measure of patient outcome within the NHS. The SF36 seems acceptable to patients, internally consistent, and a valid measure of the health status of a wide range of patients. Before it can be used in the new health service, however, its sensitivity to changes in health status over time must also be tested. PMID:8518640

Interexaminer reliability in clinical measurement of L*C*h* values of anterior teeth using a spectrophotometer.

PubMed

Hassel, Alexander J; Grossmann, Anne-christiane; Schmitter, Marc; Balke, Zibandeh; Buzello, Anja M

2007-01-01

The objective of this study was to investigate interexaminer reliability in the clinical measurement of the L*C*h* (lightness/value, chroma, hue) values of anterior teeth using a spectrophotometer (Vita Easyshade). The basic color of the maxillary right central incisors and canines of 23 subjects was spectrophotometrically determined by 4 clinicians and an experienced user (development manager) of the spectrophotometer. Also, to analyze the effect of different training with the instrument on interexaminer reliability, 2 of the clinicians were instructed in the use of the spectrophotometer by the experienced examiner, whereas the others instructed themselves by studying the operating manual. Agreement between all examiners was acceptable to excellent (intraclass coefficient > 0.4). The mean value of the measured differences for the central incisors of all subjects for L* values was 5 (for C* = 3.8, h* = 2.7 degrees) and for canines, the mean L* was 4.5 (C* = 3, h* = 1.6 degrees). Results from comparison of the 2 different training methods were inconsistent. Agreement with the experienced examiner ranged from not acceptable (C* values for incisors of self-instructed examiners) to excellent. The distribution of the measurements of 1 subject could lead to deviations in color, probably with clinical impact. For canines, the measurements were at least equally reproducible (in some cases significantly more reproducible) compared to central incisors. Because of the small number of examiners and the inconsistent results, it was not possible to reach a definite conclusion about the effect of different training methods on interexaminer reliability.

28 CFR 70.44 - Procurement procedures.

Code of Federal Regulations, 2010 CFR

2010-07-01

.... Consideration must be given to such matters as contractor integrity, record of past performance, financial and... performed or performance required, including the range of acceptable characteristics or minimum acceptable...

43 CFR 12.944 - Procurement procedures.

Code of Federal Regulations, 2010 CFR

2010-10-01

.... Consideration shall be given to such matters as contractor integrity, record of past performance, financial and... performed or performance required, including the range of acceptable characteristics or minimum acceptable...

Mid-Term Clinical Outcome and Reconstruction of Posterior Tibial Slope after UKA.

PubMed

Franz, Alois; Boese, Christoph Kolja; Matthies, Andrej; Leffler, Jörg; Ries, Christian

2018-05-21

Unicompartmental knee arthroplasty (UKA) has gained growing popularity over the last decades. The posterior tibial slope (PTS) has been shown to play a significant role for knee biomechanics and is thought to be crucial for clinical function of the UKA. We evaluated the clinical outcome at mid-term follow-up after UKA. Furthermore, the reconstruction of the individual PTS was analyzed. A total of 91 consecutive patients undergoing medial UKA for osteoarthritis were included. Patients were contacted by telephone for a survival analysis at a minimum of 30 months after surgery. Patient-oriented questionnaires and Knee Osteoarthritis Outcome Score (KOOS) were obtained. A retrospective chart review and radiological analysis of component alignment were performed for all patients before and at 6 weeks after surgery. Of 91 patients (93 knees) undergoing UKA, 69 patients (70 knees) were available for clinical follow-up after a mean of 56.0 (range 31-81) months post-surgery. The clinical results of the examined patients in the present study showed mean subscale scores of the KOOS and Western Ontario and McMaster Universities Osteoarthritis Index between 71 and 91%. Overall 7 of 91 patients were revised during the course of follow-up period and underwent total knee arthroplasty. A Kaplan-Meier analysis showed a survival rate for UKA of 90.5% after 48 months. Calculated implant survival was 75.9 months (95% confidence interval 72.3-79.6) at the mean. The radiographic analysis of pre- and postoperative PTS showed no differences ( p  = 0.113).UKA for osteoarthritis of the medial knee compartment shows encouraging clinical results at mid-term follow-up. The individual PTS could be reconstructed within acceptable ranges. This is a retrospective therapeutic study with Level IV. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Possibilities and Implications of Using the ICF and Other Vocabulary Standards in Electronic Health Records.

PubMed

Vreeman, Daniel J; Richoz, Christophe

2015-12-01

There is now widespread recognition of the powerful potential of electronic health record (EHR) systems to improve the health-care delivery system. The benefits of EHRs grow even larger when the health data within their purview are seamlessly shared, aggregated and processed across different providers, settings and institutions. Yet, the plethora of idiosyncratic conventions for identifying the same clinical content in different information systems is a fundamental barrier to fully leveraging the potential of EHRs. Only by adopting vocabulary standards that provide the lingua franca across these local dialects can computers efficiently move, aggregate and use health data for decision support, outcomes management, quality reporting, research and many other purposes. In this regard, the International Classification of Functioning, Disability, and Health (ICF) is an important standard for physiotherapists because it provides a framework and standard language for describing health and health-related states. However, physiotherapists and other health-care professionals capture a wide range of data such as patient histories, clinical findings, tests and measurements, procedures, and so on, for which other vocabulary standards such as Logical Observation Identifiers Names and Codes and Systematized Nomenclature Of Medicine Clinical Terms are crucial for interoperable communication between different electronic systems. In this paper, we describe how the ICF and other internationally accepted vocabulary standards could advance physiotherapy practise and research by enabling data sharing and reuse by EHRs. We highlight how these different vocabulary standards fit together within a comprehensive record system, and how EHRs can make use of them, with a particular focus on enhancing decision-making. By incorporating the ICF and other internationally accepted vocabulary standards into our clinical information systems, physiotherapists will be able to leverage the potent capabilities of EHRs and contribute our unique clinical perspective to other health-care providers within the emerging electronic health information infrastructure. Copyright © 2013 John Wiley & Sons, Ltd.

Engaging with clinicians to implement and evaluate the ICF in neurorehabilitation practice.

PubMed

Tempest, Stephanie; Jefferson, Richard

2015-01-01

Although deemed a globally accepted framework, there remains scare evidence on the process and outcome of implementing the International Classification of Functioning, Disability and Health (ICF) within neurorehabilitation. This review briefly explores the existing, broader literature and then reports on two action research projects, undertaken in England, specifically within stroke and neurorehabilitation. Working with participants, including clinicians from in-patient and community settings, there are now 35 different ways identified for the use of the ICF. The outcome of the first project highlights that using the ICF enhances communication within and beyond the acute stroke service, fosters holistic thinking and clarifies team roles. To adopt it into clinical practice, the ICF must be adapted to meet local service needs. The use of action research has facilitated the knowledge translation process which has enabled the ICF to become a clinical reality in neurorehabilitation, with clinicians identifying a range of potential uses.

Albumin in chronic liver disease: structure, functions and therapeutic implications.

PubMed

Spinella, Rosaria; Sawhney, Rohit; Jalan, Rajiv

2016-01-01

Human serum albumin is a critical plasma protein produced by the liver with a number of accepted clinical indications in chronic liver disease including management of circulatory and renal dysfunction in patients with ascites. Advanced cirrhosis is characterised by reduced albumin concentration as well as impaired albumin function as a result of specific structural changes and oxidative damage. Traditionally, the biologic and therapeutic role of albumin in liver disease was attributed to its oncotic effects but it is now understood that albumin has a wide range of other important physiologic functions such as immunomodulation, endothelial stabilisation, antioxidant effects and binding multiple drugs, toxins and other molecules. This review discusses the multifunctional properties of albumin and, in particular, the biologic and clinical implications of structural and functional changes of albumin that are associated with cirrhosis. Based on these insights, we explore the current and potential future therapeutic uses of albumin in liver disease.

Increased Patient Enrollment to a Randomized Surgical Trial Through Equipoise Polling of an Expert Surgeon Panel.

PubMed

Ghogawala, Zoher; Schwartz, J Sanford; Benzel, Edward C; Magge, Subu N; Coumans, Jean Valery; Harrington, J Fred; Gelbs, Jared C; Whitmore, Robert G; Butler, William E; Barker, Fred G

2016-07-01

To determine whether patients who learned the views of an expert surgeons' panel's assessment of equipoise between 2 alternative operative treatments had increased likelihood of consenting to randomization. Difficulty obtaining patient consent to randomization is an important barrier to conducting surgical randomized clinical trials, the gold standard for generating clinical evidence. Observational study of the rate of patient acceptance of randomization within a 5-center randomized clinical trial comparing lumbar spinal decompression versus lumbar spinal decompression plus instrumented fusion for patients with symptomatic grade I degenerative lumbar spondylolisthesis with spinal stenosis. Eligible patients were enrolled in the trial and then asked to accept randomization. A panel of 10 expert spine surgeons was formed to review clinical information and images for individual patients to provide an assessment of suitability for randomization. The expert panel vote was disclosed to the patient by the patient's surgeon before the patient decided whether to accept randomization or not. Randomization acceptance among eligible patients without expert panel review was 40% (19/48) compared with 81% (47/58) among patients undergoing expert panel review (P < 0.001). Among expert-reviewed patients, randomization acceptance was 95% when all experts or all except 1 voted for randomization, 75% when 2 experts voted against randomization, and 20% with 3 or 4 votes against (P < 0.001 for trend). Patients provided with an expert panel's assessment of their own suitability for randomization were twice as likely to agree to randomization compared with patients receiving only their own surgeon's recommendation.

An investigation on physicians' acceptance of hospital information systems: a case study.

PubMed

Chen, Rai-Fu; Hsiao, Ju-Ling

2012-12-01

Information technology is used to support a wide range of highly specified healthcare tasks and services. There is, therefore, a need to understand the factors affecting the acceptance of this technology by healthcare professionals. Physicians are key providers of healthcare services and are among the principal users of hospital information systems. Their acceptance of hospital information systems is hence of great significance when evaluating the success of those systems. The survey methodology was employed to targeted physicians in the selected case hospital for investigating factors affecting physicians' acceptance of hospital information systems. A total of 202 questionnaires were sent out, with 124 completed copies returned, indicating a valid response rate of 61.4%. We used structural equation modeling to analyze the data. The results indicated that top management support (γ=0.431, p<0.001) had a significant impact on perceived usefulness. Project team competency (γ=0.381, p<0.001) and system quality (γ=0.369, p<0.001) had a significant impact on physicians' perceived ease of use of hospital information systems. Physicians' perceptions of the usefulness (β=0.132, p<0.05, R(2)=0.296) and ease of use (β=0.952, p<0.001, R(2)=0.784) of hospital information systems had a significant impact on the acceptance of the systems, accounting for 81.4% of total explained variance. Through the understanding of the identified critical factors affecting physicians' HIS acceptance, the planners and managers should ensure that hospital information systems to be introduced into a hospital are useful and ease to use. Effort should be focuses on providing sufficient top management support, selecting qualified project team members, and delivering higher system quality in addressing physicians' clinical needs. Thus, our research results can help planners and managers understand key considerations affecting HIS development and use, and may be used as a reference for system design, development and implementation. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Management of comminuted patellar fracture with non-absorbable suture cerclage and Nitinol patellar concentrator.

PubMed

Lue, Tan Hong; Feng, Liu Wei; Jun, Wang Ming; Yin, Li Wu

2014-12-01

To evaluate the effectiveness and safety of a fixation technique for comminuted patellar fracture using non-absorbable suture cerclage and nickel-titanium patellar concentrator (Ni-Ti PC). Twenty-nine consecutive patients with displaced comminuted patellar fractures accepted internal fixation procedure using Ni-Ti PC augmented with different types of non-absorbable suture cerclage. During follow-up, the clinical grading scales of Böstman, including range of movement, pain, work, atrophy, assistance in walking, effusion, giving way, and stair-climbing, were used to evaluate the clinical results. Complications including implant loosening, fragment displacement, bone nonunion, infection, breakage of the implants, painful hardware, and post-traumatic osteoarthritis were also assessed. Patients were followed up for a mean period of 27 months. The bone union radiographically occurred approximately 2.5 months without implant loosening and fragment displacement. According to Böstman method, satisfactory results were obtained, and the mean score at final follow-up was 28 (range 20–30) points. Twenty-two patients with excellent results had mean score of 29.8 ± 0.5 (range 28–30) and seven patients with good results had mean score of 22.7 ± 3.14 (range 20–27). No postoperative complications, such as infection, dislocation, breakage of the implants, painful hardware, and post-traumatic osteoarthritis, were observed. Ni-Ti PC fixation with non-absorbable suture cerclage is a feasible approach for comminuted patellar fractures. Firm fixation with this technique resulted in satisfactory outcomes without obvious complications.

Measuring personal beliefs and perceived norms about intimate partner violence: Population-based survey experiment in rural Uganda

PubMed Central

Kakuhikire, Bernard; McDonough, Amy Q.; Ogburn, Elizabeth L.; Downey, Jordan M.; Bangsberg, David R.

2017-01-01

Background Demographic and Health Surveys (DHS) conducted throughout sub-Saharan Africa indicate there is widespread acceptance of intimate partner violence, contributing to an adverse health risk environment for women. While qualitative studies suggest important limitations in the accuracy of the DHS methods used to elicit attitudes toward intimate partner violence, to date there has been little experimental evidence from sub-Saharan Africa that can be brought to bear on this issue. Methods and findings We embedded a randomized survey experiment in a population-based survey of 1,334 adult men and women living in Nyakabare Parish, Mbarara, Uganda. The primary outcomes were participants’ personal beliefs about the acceptability of intimate partner violence and perceived norms about intimate partner violence in the community. To elicit participants’ personal beliefs and perceived norms, we asked about the acceptability of intimate partner violence in five different vignettes. Study participants were randomly assigned to one of three survey instruments, each of which contained varying levels of detail about the extent to which the wife depicted in the vignette intentionally or unintentionally violated gendered standards of behavior. For the questions about personal beliefs, the mean (standard deviation) number of items where intimate partner violence was endorsed as acceptable was 1.26 (1.58) among participants assigned to the DHS-style survey variant (which contained little contextual detail about the wife’s intentions), 2.74 (1.81) among participants assigned to the survey variant depicting the wife as intentionally violating gendered standards of behavior, and 0.77 (1.19) among participants assigned to the survey variant depicting the wife as unintentionally violating these standards. In a partial proportional odds regression model adjusting for sex and village of residence, with participants assigned to the DHS-style survey variant as the referent group, participants assigned the survey variant that depicted the wife as intentionally violating gendered standards of behavior were more likely to condone intimate partner violence in a greater number of vignettes (adjusted odds ratios [AORs] ranged from 3.87 to 5.74, with all p < 0.001), while participants assigned the survey variant that depicted the wife as unintentionally violating these standards were less likely to condone intimate partner violence (AORs ranged from 0.29 to 0.70, with p-values ranging from <0.001 to 0.07). The analysis of perceived norms displayed similar patterns, but the effects were slightly smaller in magnitude: participants assigned to the “intentional” survey variant were more likely to perceive intimate partner violence as normative (AORs ranged from 2.05 to 3.51, with all p < 0.001), while participants assigned to the “unintentional” survey variant were less likely to perceive intimate partner violence as normative (AORs ranged from 0.49 to 0.65, with p-values ranging from <0.001 to 0.14). The primary limitations of this study are that our assessments of personal beliefs and perceived norms could have been measured with error and that our findings may not generalize beyond rural Uganda. Conclusions Contextual information about the circumstances under which women in hypothetical vignettes were perceived to violate gendered standards of behavior had a significant influence on the extent to which study participants endorsed the acceptability of intimate partner violence. Researchers aiming to assess personal beliefs or perceived norms about intimate partner violence should attempt to eliminate, as much as possible, ambiguities in vignettes and questions administered to study participants. Trial registration ClinicalTrials.gov NCT02202824. PMID:28542176

Measuring personal beliefs and perceived norms about intimate partner violence: Population-based survey experiment in rural Uganda.

PubMed

Tsai, Alexander C; Kakuhikire, Bernard; Perkins, Jessica M; Vořechovská, Dagmar; McDonough, Amy Q; Ogburn, Elizabeth L; Downey, Jordan M; Bangsberg, David R

2017-05-01

Demographic and Health Surveys (DHS) conducted throughout sub-Saharan Africa indicate there is widespread acceptance of intimate partner violence, contributing to an adverse health risk environment for women. While qualitative studies suggest important limitations in the accuracy of the DHS methods used to elicit attitudes toward intimate partner violence, to date there has been little experimental evidence from sub-Saharan Africa that can be brought to bear on this issue. We embedded a randomized survey experiment in a population-based survey of 1,334 adult men and women living in Nyakabare Parish, Mbarara, Uganda. The primary outcomes were participants' personal beliefs about the acceptability of intimate partner violence and perceived norms about intimate partner violence in the community. To elicit participants' personal beliefs and perceived norms, we asked about the acceptability of intimate partner violence in five different vignettes. Study participants were randomly assigned to one of three survey instruments, each of which contained varying levels of detail about the extent to which the wife depicted in the vignette intentionally or unintentionally violated gendered standards of behavior. For the questions about personal beliefs, the mean (standard deviation) number of items where intimate partner violence was endorsed as acceptable was 1.26 (1.58) among participants assigned to the DHS-style survey variant (which contained little contextual detail about the wife's intentions), 2.74 (1.81) among participants assigned to the survey variant depicting the wife as intentionally violating gendered standards of behavior, and 0.77 (1.19) among participants assigned to the survey variant depicting the wife as unintentionally violating these standards. In a partial proportional odds regression model adjusting for sex and village of residence, with participants assigned to the DHS-style survey variant as the referent group, participants assigned the survey variant that depicted the wife as intentionally violating gendered standards of behavior were more likely to condone intimate partner violence in a greater number of vignettes (adjusted odds ratios [AORs] ranged from 3.87 to 5.74, with all p < 0.001), while participants assigned the survey variant that depicted the wife as unintentionally violating these standards were less likely to condone intimate partner violence (AORs ranged from 0.29 to 0.70, with p-values ranging from <0.001 to 0.07). The analysis of perceived norms displayed similar patterns, but the effects were slightly smaller in magnitude: participants assigned to the "intentional" survey variant were more likely to perceive intimate partner violence as normative (AORs ranged from 2.05 to 3.51, with all p < 0.001), while participants assigned to the "unintentional" survey variant were less likely to perceive intimate partner violence as normative (AORs ranged from 0.49 to 0.65, with p-values ranging from <0.001 to 0.14). The primary limitations of this study are that our assessments of personal beliefs and perceived norms could have been measured with error and that our findings may not generalize beyond rural Uganda. Contextual information about the circumstances under which women in hypothetical vignettes were perceived to violate gendered standards of behavior had a significant influence on the extent to which study participants endorsed the acceptability of intimate partner violence. Researchers aiming to assess personal beliefs or perceived norms about intimate partner violence should attempt to eliminate, as much as possible, ambiguities in vignettes and questions administered to study participants. ClinicalTrials.gov NCT02202824.

[Is psychoprophylaxis a valid approach for heart surgery in children?].

PubMed

Pereira Ruschel, P; Pierini Cidade, D; Daudt, N S; Rossi Filho, R I

1995-10-01

To validate the hypothesys that a psycological preparation for children who will undergo cardiac surgery may improve the outcome. Sixty patients, with ages ranging between 3 and 10 years, submitted to heart surgery for treatment of congenital heart defects, were evaluated. They were divided in 2 groups: experimental and control. A questionnaire was designed for collecting data about psychological and clinical aspects of each patient. The following data was found to be of statistical significance: acceptance of peripheral vein puncture in the surgical group (chi 2 = 11.59, p < 0.05), calm awakening following general anesthesia (chi 2 = 9.64 p < 0.05), cooperation with the physiotherapy staff (chi 2 = 13.30, p < 0.05), coping with parents absence (chi 2 = 9.64, p < 0.05), acceptance of fluid restriction (chi 2 = 17.78, p < 0.05) and cooperation with removal of stitches and pacemaker electrodes (chi 2 = 19.20, p < 0.05). There was not statistical significance on demand of sedation, cooperation at removal of the orotracheal tube and during examination, necessity of reintubation and occurrence of clinical complications. However, the prepared group showed a slight tendency to have less postoperative complications (20%) than the control (27%). It was found that children who had adequated psychologic preparation prior to the correction of congenital heart defects had better psychological results with the imposed trauma.

Results of the Minnesota Multiphasic Personality Inventory-2 among gestational surrogacy candidates.

PubMed

Klock, Susan C; Covington, Sharon N

2015-09-01

To obtain normative data on the Minnesota Multiphasic Personality Inventory-2 (MMPI-2) personality test for gestational surrogate (GS) candidates. A retrospective study was undertaken through chart review of all GS candidates assessed at Shady Grove Fertility Center, Rockville, MD, USA, between June 2007 and December 2009. Participants completed the MMPI-2 test during screening. MMPI-2 scores, demographic information, and screening outcome were retrieved. Among 153 included candidates, 132 (86.3%) were accepted to be a GS, 6 (3.9%) were ruled out because of medical reasons, and 15 (9.8%) were ruled out because of psychological reasons. The mean scores on each of the MMPI-2 scales were within the normal range. A score of more than 65 (the clinical cutoff) was recorded on the L scale for 46 (30.1%) candidates, on the K scale for 61 (39.9%), and on the S scale for 84 (54.9%). Women who were ruled out for psychological reasons had significantly higher mean scores on the validity scales F and L, and on clinical scale 8 than did women who were accepted (P<0.05 for all). Most GS candidates are well adjusted and free of psychopathology, but candidates tend to present themselves in an overly positive way. Copyright © 2015 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Development and psychometric testing of the nursing student mentors' competence instrument (MCI): A cross-sectional study.

PubMed

Tuomikoski, Anna-Maria; Ruotsalainen, Heidi; Mikkonen, Kristina; Miettunen, Jouko; Kääriäinen, Maria

2018-06-05

Mentors require competence at a diverse array of skills to mentor students during clinical practice. According to the latest evidence, competence at mentoring includes: knowledge, skills and attributes of individual students' learning objectives, core elements of nursing, learning processes, a reciprocal and trustful relationship, feedback, evaluation, cooperation with stakeholders, and the mentor's personal qualities. The purpose of the study was to test psychometric properties of a mentor's competence instrument developed to self-evaluate mentors' competence at mentoring nursing students in clinical practice. A cross-sectional, descriptive, explorative study design was used. Data were collected from mentors at five university hospitals in Finland in 2016. A total of 576 mentors participated in this study. The instrument was developed through systematic review, experts' evaluations, and pilot versions of the instrument tested in previous studies. The construct validity and reliability of the instrument were tested using exploratory factor analysis (EFA) with promax rotation and Cronbach's alpha. A 10-factor model showed that the instrument has acceptable construct validity. Cronbach's alpha values for the subscales observed ranged from 0.76 to 0.90. The instrument exhibited acceptable psychometric properties, thereby proving itself a valuable tool for evaluating mentors' competence at mentoring students. Further assessments of its reliability, validity and generality for measuring mentor's competence for mentoring students in different contexts and cultures are recommended. Copyright © 2018 Elsevier Ltd. All rights reserved.

SU-E-J-141: Comparison of Dose Calculation On Automatically Generated MRBased ED Maps and Corresponding Patient CT for Clinical Prostate EBRT Plans

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

Schadewaldt, N; Schulz, H; Helle, M

2014-06-01

Purpose: To analyze the effect of computing radiation dose on automatically generated MR-based simulated CT images compared to true patient CTs. Methods: Six prostate cancer patients received a regular planning CT for RT planning as well as a conventional 3D fast-field dual-echo scan on a Philips 3.0T Achieva, adding approximately 2 min of scan time to the clinical protocol. Simulated CTs (simCT) where synthesized by assigning known average CT values to the tissue classes air, water, fat, cortical and cancellous bone. For this, Dixon reconstruction of the nearly out-of-phase (echo 1) and in-phase images (echo 2) allowed for water andmore » fat classification. Model based bone segmentation was performed on a combination of the DIXON images. A subsequent automatic threshold divides into cortical and cancellous bone. For validation, the simCT was registered to the true CT and clinical treatment plans were re-computed on the simCT in pinnacle{sup 3}. To differentiate effects related to the 5 tissue classes and changes in the patient anatomy not compensated by rigid registration, we also calculate the dose on a stratified CT, where HU values are sorted in to the same 5 tissue classes as the simCT. Results: Dose and volume parameters on PTV and risk organs as used for the clinical approval were compared. All deviations are below 1.1%, except the anal sphincter mean dose, which is at most 2.2%, but well below clinical acceptance threshold. Average deviations are below 0.4% for PTV and risk organs and 1.3% for the anal sphincter. The deviations of the stratifiedCT are in the same range as for the simCT. All plans would have passed clinical acceptance thresholds on the simulated CT images. Conclusion: This study demonstrated the clinical usability of MR based dose calculation with the presented Dixon acquisition and subsequent fully automatic image processing. N. Schadewaldt, H. Schulz, M. Helle and S. Renisch are employed by Phlips Technologie Innovative Techonologies, a subsidiary of Royal Philips NV.« less

Boosting Quality Registries with Clinical Decision Support Functionality*. User Acceptance of a Prototype Applied to HIV/TB Drug Therapy.

PubMed

Wannheden, Carolina; Hvitfeldt-Forsberg, Helena; Eftimovska, Elena; Westling, Katarina; Ellenius, Johan

2017-08-11

The care of HIV-related tuberculosis (HIV/TB) is complex and challenging. Clinical decision support (CDS) systems can contribute to improve quality of care, but more knowledge is needed on factors determining user acceptance of CDS. To analyze physicians' and nurses' acceptance of a CDS prototype for evidence-based drug therapy recommendations for HIV/TB treatment. Physicians and nurses were involved in designing a CDS prototype intended for future integration with the Swedish national HIV quality registry. Focus group evaluation was performed with ten nurses and four physicians, respectively. The Unified Theory of Acceptance and Use of Technology (UTAUT) was used to analyze acceptance. We identified several potential benefits with the CDS prototype as well as some concerns that could be addressed by redesign. There was also concern about dependence on physician attitudes, as well as technical, organizational, and legal issues. Acceptance evaluation at a prototype stage provided rich data to improve the future design of a CDS prototype. Apart from design and development efforts, substantial organizational efforts are needed to enable the implementation and maintenance of a future CDS system.

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

Ma, R; Zhu, X; Li, S

Purpose: High Dose Rate (HDR) brachytherapy forward planning is principally an iterative process; hence, plan quality is affected by planners’ experiences and limited planning time. Thus, this may lead to sporadic errors and inconsistencies in planning. A statistical tool based on previous approved clinical treatment plans would help to maintain the consistency of planning quality and improve the efficiency of second checking. Methods: An independent dose calculation tool was developed from commercial software. Thirty-three previously approved cervical HDR plans with the same prescription dose (550cGy), applicator type, and treatment protocol were examined, and ICRU defined reference point doses (bladder, vaginalmore » mucosa, rectum, and points A/B) along with dwell times were collected. Dose calculation tool then calculated appropriate range with a 95% confidence interval for each parameter obtained, which would be used as the benchmark for evaluation of those parameters in future HDR treatment plans. Model quality was verified using five randomly selected approved plans from the same dataset. Results: Dose variations appears to be larger at the reference point of bladder and mucosa as compared with rectum. Most reference point doses from verification plans fell between the predicted range, except the doses of two points of rectum and two points of reference position A (owing to rectal anatomical variations & clinical adjustment in prescription points, respectively). Similar results were obtained for tandem and ring dwell times despite relatively larger uncertainties. Conclusion: This statistical tool provides an insight into clinically acceptable range of cervical HDR plans, which could be useful in plan checking and identifying potential planning errors, thus improving the consistency of plan quality.« less

Assessing patient acceptance of virtual clinics for diabetic retinopathy: a large scale postal survey.

PubMed

Ahnood, Dana; Souriti, Ahmad; Williams, Gwyn Samuel

2018-06-01

To explore the views of patients with diabetic retinopathy and maculopathy on their acceptance of virtual clinic review in place of face-to-face clinic appointments. A postal survey was mailed to all 813 patients under the care of the diabetic eye clinic at Singleton Hospital with 7 questions, explanatory information, and a stamped, addressed envelope available for returning completed questionnaires. Four hundred and ninety-eight questionnaires were returned indicating that 86.1% were supportive of the idea of virtual clinics, although only 56.9% were prepared for every visit to be virtual. Of respondents, 6.6% not happy to attend any virtual clinic. This is by far the largest survey of patients' attitudes regarding attending virtual clinics and confirms that the vast majority are supportive of this mode of health care delivery. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

Research information knowledge, perceived adequacy, and understanding in cancer clinical trial participants.

PubMed

Biedrzycki, Barbara A

2011-07-01

To describe the adequacy of research information among people with cancer at the time they accept or decline participation in a cancer clinical trial. Cross-sectional, descriptive. An urban, academic, National Cancer Institute-designated comprehensive cancer center. 197 patients with advanced gastrointestinal cancer. Mailed survey; self-reported data. Adequacy of research information (actual knowledge, perceived adequacy of information, and perceived understanding), cancer clinical trial participation, and satisfaction with the decision to participate. Most respondents (88%) perceived themselves as having adequate information to make an informed decision regarding cancer clinical trial participation. In addition, 35% demonstrated adequate knowledge of basic clinical research. Patients decide to accept or decline cancer clinical trials without having adequate knowledge. Nurses have an important role in educating patients regarding cancer clinical trials. The ideal teachable moment may not occur at the time of diagnosis; other less stressful opportunities may present when the patient is more receptive.

Correction of antebrachial angulation-rotation deformities in dogs with oblique plane inclined osteotomies.

PubMed

Franklin, Samuel P; Dover, Ryan K; Andrade, Natalia; Rosselli, Desiree; M Clarke, Kevin

2017-11-01

To describe oblique plane inclined osteotomies and report preliminary data on outcomes in dogs treated for antebrachial angulation-rotation deformities. Retrospective clinical study. Six antebrachii from 5 dogs. Records of dogs with antebrachial angulation-rotation deformities treated with oblique plane inclined osteotomies were reviewed. Postoperative frontal, sagittal, and transverse plane alignments were assessed subjectively, and alignment in the frontal and sagittal planes was quantified on radiographs. Outcomes were classified based on owner's and veterinarian's evaluation as full, acceptable, and unacceptable function. Complications were classified as minor, major, or catastrophic. Limb alignment was subjectively considered excellent in 1 case, good in 3 cases, and fair in 2 cases. Osseous union was achieved in all cases (mean 10.5 weeks; range, 6-13 weeks). Outcomes were assessed by the veterinarian as return to full function in 5 cases and acceptable function in 1 case at the final in-hospital follow-up (mean 44 weeks; range, 6-124 weeks). All owners classified their dogs as returning to full function at the final phone/email interview (mean 107 weeks; range, 72-153 weeks). Implants were removed due to infection or irritation in 3/6 limbs, while the other 3 limbs had minor dermatitis secondary to postoperative external coaptation. No catastrophic complications occurred. Oblique plane inclined osteotomies led to a successful outcome in all 6 limbs, but the technique can be challenging and does not always lead to optimal alignment. Future refinement of this technique could focus on the development of patient-specific osteotomy guides to improve accuracy and precision. © 2017 The American College of Veterinary Surgeons.

Clinical Utility of the Modified Segmental Boost Technique for Treatment of the Pelvis and Inguinal Nodes

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

Moran, M.S., E-mail: meena.moran@yale.ed; Yale New Haven Hospital, New Haven, Connecticut and William W. Backus Hospital, Norwich, Connecticut; Castrucci, W.A.

2010-03-15

Purpose: Low-lying pelvic malignancies often require simultaneous radiation to pelvis and inguinal nodes. We previously reported improved homogeneity with the modified segmental boost technique (MSBT) compared to that with traditional methods, using phantom models. Here we report our institutional clinical experience with MSBT. Methods and Materials: MSBT patients from May 2001 to March 2007 were evaluated. Parameters analyzed included isocenter/multileaf collimation shifts, time per fraction (four fields), monitor units (MU)/fraction, femoral doses, maximal dose relative to body mass index, and inguinal node depth. In addition, a dosimetric comparison of the MSBT versus intensity modulated radiation therapy (IMRT) was conducted. Results:more » Of the 37 MSBT patients identified, 32 were evaluable. Port film adjustments were required in 6% of films. Median values for each analyzed parameter were as follows: MU/fraction, 298 (range, 226-348); delivery time, 4 minutes; inguinal depth, 4.5 cm; volume receiving 45 Gy (V45), 7%; V27.5, 87%; body mass index, 25 (range, 16.0-33.8). Inguinal dose was 100% in all cases; in-field inhomogeneity ranged from 111% to 118%. IMRT resulted in significantly decreased dose to normal tissue but required more time for treatment planning and a higher number of MUs (1,184 vs. 313 MU). Conclusions: In our clinical experience, the mono-isocentric MSBT provides a high degree of accuracy, improved homogeneity compared with traditional techniques, ease of simulation, treatment planning, treatment delivery, and acceptable femoral doses for pelvic/inguinal radiation fields requiring 45 to 50.4 Gy. In addition, the MSBT delivers a relatively uniform dose distribution throughout the treatment volume, despite varying body habitus. Clinical scenarios for the use of MSBT vs. intensity-modulated radiation therapy are discussed. To our knowledge, this is the first study reporting the utility of MSBT in the clinical setting.« less

Accreditation of medical laboratories in Croatia--experiences of the Institute of Clinical Chemistry, University Hospital "Merkur", Zagreb.

PubMed

Flegar-Mestrić, Zlata; Nazor, Aida; Perkov, Sonja; Surina, Branka; Kardum-Paro, Mirjana Mariana; Siftar, Zoran; Sikirica, Mirjana; Sokolić, Ivica; Ozvald, Ivan; Vidas, Zeljko

2010-03-01

Since 2003 when the international norm for implementation of quality management in medical laboratories (EN ISO 15189, Medical laboratories--Particular requirements for quality and competence) was established and accepted, accreditation has become practical, generally accepted method of quality management and confirmation of technical competence of medical laboratories in the whole world. This norm has been translated into Croatian and accepted by the Croatian Institute for Norms as Croatian norm. Accreditation is carried out on voluntary basis by the Croatian Accreditation Agency that has up to now accredited two clinical medical biochemical laboratories in the Republic of Croatia. Advantages of accredited laboratory lie in its documented management system, constant improvement and training, reliability of test results, establishing users' trust in laboratory services, test results comparability and interlaboratory (international) test results acceptance by adopting the concept of metrological traceability in laboratory medicine.

Cross-validation of commercial enzyme-linked immunosorbent assay and radioimmunoassay for porcine C-peptide concentration measurements in non-human primate serum.

PubMed

Gresch, Sarah C; Mutch, Lucas A; Janecek, Jody L; Hegstad-Davies, Rebecca L; Graham, Melanie L

2017-09-01

C-peptide concentration is widely used as a marker of insulin secretion and is especially relevant in evaluating islet graft function following transplantation, because its measurement is not confounded by the presence of exogenous insulin. To address the shortage of human islet donors, the use of porcine islets has been proposed as a possible solution and the stringent pig-to-non-human primate (NHP) model is often the most relevant for pre-clinical evaluation of the potential for diabetes reversal resulting from an islet xenograft. The Millipore radioimmunoassay (RIA) was exclusively used to measure porcine C-peptide (PCP) until 2013 when the assay was discontinued and subsequently a commercially available enzyme-linked immunosorbent assay (ELISA) from Mercodia has been widely adopted. Both assays have been used in pre-clinical trials evaluating the therapeutic potential of xenograft products in reversing diabetes in the pig-to-NHP model, to interpret data in a comparable way it may be useful to perform a harmonization of C-peptide measurements. We performed a method comparison by determining the PCP concentration in 620 serum samples collected from 20 diabetic cynomolgus macaques transplanted with adult porcine islets. All analyses were performed according to manufacturer instructions. With both assays, we demonstrated an acceptable detection limit, precision, and recovery. Linearity of the ELISA met acceptance criteria at all concentrations tested while linearity of the RIA only met acceptance criteria at five of the eight concentrations tested. The RIA had a detection limit of 0.16 ng/mL, and recovery ranged from 82% to 96% and met linearity acceptance criteria at 0.35 ng/mL and from 0.78 to 2.33 ng/mL. The ELISA had a detection limit of 0.03 ng/mL, and recovery ranged from 81% to 115% and met linearity acceptance criteria from 0.08 to 0.85 ng/mL. Both assays had intra-assay precision <11% and inter-assay precision <14%. PCP concentration measured by ELISA demonstrated a significant correlation with RIA (R 2 =.9721, P<.0001). This strong correlation supports use of the regression equation y=2.029x+0.0897 to transform ELISA data to RIA or inversely y=0.4930x-0.0456 to convert RIA data to ELISA for direct comparison between assays in the concentration range of 0-3.0 ng/mL. Measured C-peptide concentration was lower with the ELISA than with the RIA; individual measurements plotted against the averages of the pair demonstrated that the variability from the mean strongly depended on increasing concentration. Porcine C-peptide can be reliably measured in NHP serum using the Mercodia ELISA, making this assay interchangeable with the Millipore RIA. Inherent differences in antibody affinity and calibration factors may explain the lower ELISA values as compared to the RIA; however without access to a traceable reference standard, it is not possible to determine which assay is most accurate. Regression modeling resulted in a correction factor appropriate for conversion of ELISA data to RIA-equivalent data facilitating comparison of assay results longitudinally and between groups. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Patient acceptability, efficacy, and skin biophysiology of a cream and cleanser containing lipid complex with shea butter extract versus a ceramide product for eczema.

PubMed

Hon, K L; Tsang, Y C; Pong, N H; Lee, Vivian W Y; Luk, N M; Chow, C M; Leung, T F

2015-10-01

To investigate patient acceptability, efficacy, and skin biophysiological effects of a cream/cleanser combination for childhood atopic dermatitis. Paediatric dermatology clinic at a university teaching hospital in Hong Kong. Consecutive paediatric patients with atopic dermatitis who were interested in trying a new moisturiser were recruited between 1 April 2013 and 31 March 2014. Swabs and cultures from the right antecubital fossa and the worst eczematous area, disease severity (SCORing Atopic Dermatitis index), skin hydration, and transepidermal water loss were obtained prior to and following 4-week usage of a cream/cleanser containing lipid complex with shea butter extract (Ezerra cream; Hoe Pharma, Petaling Jaya, Malaysia). Global or general acceptability of treatment was documented as 'very good', 'good', 'fair', or 'poor'. A total of 34 patients with atopic dermatitis were recruited; 74% reported 'very good' or 'good', whereas 26% reported 'fair' or 'poor' general acceptability of treatment of the Ezerra cream; and 76% reported 'very good' or 'good', whereas 24% reported 'fair' or 'poor' general acceptability of treatment of the Ezerra cleanser. There were no intergroup differences in pre-usage clinical parameters of age, objective SCORing Atopic Dermatitis index, pruritus, sleep loss, skin hydration, transepidermal water loss, topical corticosteroid usage, oral antihistamine usage, or general acceptability of treatment of the prior emollient. Following use of the Ezerra cream, mean pruritus score decreased from 6.7 to 6.0 (P=0.036) and mean Children's Dermatology Life Quality Index improved from 10.0 to 8.0 (P=0.021) in the 'very good'/'good' group. There were no statistically significant differences in the acceptability of wash (P=0.526) and emollients (P=0.537) with pre-trial products. When compared with the data of another ceramide-precursor moisturiser in a previous study, there was no statistical difference in efficacy and acceptability between the two products. The trial cream was acceptable in three quarters of patients with atopic dermatitis. Patients who accepted the cream had less pruritus and improved quality of life than the non-accepting patients following its usage. The cream containing shea butter extract did not differ in acceptability or efficacy from a ceramide-precursor product. Patient acceptability is an important factor for treatment efficacy. There is a general lack of published clinical trials to document the efficacy and skin biophysiological effects of many of the proprietary moisturisers.

Gynecologic Oncology Group quality assurance audits: analysis and initiatives for improvement.

PubMed

Blessing, John A; Bialy, Sally A; Whitney, Charles W; Stonebraker, Bette L; Stehman, Frederick B

2010-08-01

The Gynecologic Oncology Group (GOG) is a multi-institution, multi-discipline Cooperative Group funded by the National Cancer Institute (NCI) to conduct clinical trials which investigate the treatment, prevention, control, quality of survivorship, and translational science of gynecologic malignancies. In 1982, the NCI initiated a program of on-site quality assurance audits of participating institutions. Each is required to be audited at least once every 3 years. In GOG, the audit mandate is the responsibility of the GOG Quality Assurance Audit Committee and it is centralized in the Statistical and Data Center (SDC). Each component (Regulatory, Investigational Drug Pharmacy, Patient Case Review) is classified as Acceptable, Acceptable, follow-up required, or Unacceptable. To determine frequently occurring deviations and develop focused innovative solutions to address them. A database was created to examine the deviations noted at the most recent audit conducted at 57 GOG parent institutions during 2004-2007. Cumulatively, this involved 687 patients and 306 protocols. The results documented commendable performance: Regulatory (39 Acceptable, 17 Acceptable, follow-up, 1 Unacceptable); Pharmacy (41 Acceptable, 3 Acceptable, follow-up, 1 Unacceptable, 12 N/A): Patient Case Review (31 Acceptable, 22 Acceptable, follow-up, 4 Unacceptable). The nature of major and lesser deviations was analyzed to create and enhance initiatives for improvement of the quality of clinical research. As a result, Group-wide proactive initiatives were undertaken, audit training sessions have emphasized recurring issues, and GOG Data Management Subcommittee agendas have provided targeted instruction and training. The analysis was based upon parent institutions only; affiliate institutions and Community Clinical Oncology Program participants were not included, although it is assumed their areas of difficulty are similar. The coordination of the GOG Quality Assurance Audit program in the SDC has improved data quality by enhancing our ability to identify frequently occurring deviations and develop innovative solutions to avoid or minimize their occurrence in the future.

Reasons For Physicians Not Adopting Clinical Decision Support Systems: Critical Analysis.

PubMed

Khairat, Saif; Marc, David; Crosby, William; Al Sanousi, Ali

2018-04-18

Clinical decision support systems (CDSSs) are an integral component of today's health information technologies. They assist with interpretation, diagnosis, and treatment. A CDSS can be embedded throughout the patient safety continuum providing reminders, recommendations, and alerts to health care providers. Although CDSSs have been shown to reduce medical errors and improve patient outcomes, they have fallen short of their full potential. User acceptance has been identified as one of the potential reasons for this shortfall. The purpose of this paper was to conduct a critical review and task analysis of CDSS research and to develop a new framework for CDSS design in order to achieve user acceptance. A critical review of CDSS papers was conducted with a focus on user acceptance. To gain a greater understanding of the problems associated with CDSS acceptance, we conducted a task analysis to identify and describe the goals, user input, system output, knowledge requirements, and constraints from two different perspectives: the machine (ie, the CDSS engine) and the user (ie, the physician). Favorability of CDSSs was based on user acceptance of clinical guidelines, reminders, alerts, and diagnostic suggestions. We propose two models: (1) the user acceptance and system adaptation design model, which includes optimizing CDSS design based on user needs/expectations, and (2) the input-process-output-engagemodel, which reveals to users the processes that govern CDSS outputs. This research demonstrates that the incorporation of the proposed models will improve user acceptance to support the beneficial effects of CDSSs adoption. Ultimately, if a user does not accept technology, this not only poses a threat to the use of the technology but can also pose a threat to the health and well-being of patients. ©Saif Khairat, David Marc, William Crosby, Ali Al Sanousi. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 18.04.2018.

General error analysis in the relationship between free thyroxine and thyrotropin and its clinical relevance.

PubMed

Goede, Simon L; Leow, Melvin Khee-Shing

2013-01-01

This treatise investigates error sources in measurements applicable to the hypothalamus-pituitary-thyroid (HPT) system of analysis for homeostatic set point computation. The hypothalamus-pituitary transfer characteristic (HP curve) describes the relationship between plasma free thyroxine [FT4] and thyrotropin [TSH]. We define the origin, types, causes, and effects of errors that are commonly encountered in TFT measurements and examine how we can interpret these to construct a reliable HP function for set point establishment. The error sources in the clinical measurement procedures are identified and analyzed in relation to the constructed HP model. The main sources of measurement and interpretation uncertainties are (1) diurnal variations in [TSH], (2) TFT measurement variations influenced by timing of thyroid medications, (3) error sensitivity in ranges of [TSH] and [FT4] (laboratory assay dependent), (4) rounding/truncation of decimals in [FT4] which in turn amplify curve fitting errors in the [TSH] domain in the lower [FT4] range, (5) memory effects (rate-independent hysteresis effect). When the main uncertainties in thyroid function tests (TFT) are identified and analyzed, we can find the most acceptable model space with which we can construct the best HP function and the related set point area.

A preclinical Talbot-Lau prototype for x-ray dark-field imaging of human-sized objects.

PubMed

Hauke, C; Bartl, P; Leghissa, M; Ritschl, L; Sutter, S M; Weber, T; Zeidler, J; Freudenberger, J; Mertelmeier, T; Radicke, M; Michel, T; Anton, G; Meinel, F G; Baehr, A; Auweter, S; Bondesson, D; Gaass, T; Dinkel, J; Reiser, M; Hellbach, K

2018-06-01

Talbot-Lau x-ray interferometry provides information about the scattering and refractive properties of an object - in addition to the object's attenuation features. Until recently, this method was ineligible for imaging human-sized objects as it is challenging to adapt Talbot-Lau interferometers (TLIs) to the relevant x-ray energy ranges. In this work, we present a preclinical Talbot-Lau prototype capable of imaging human-sized objects with proper image quality at clinically acceptable dose levels. The TLI is designed to match a setup of clinical relevance as closely as possible. The system provides a scan range of 120 × 30 cm 2 by using a scanning beam geometry. Its ultimate load is 100 kg. High aspect ratios and fine grid periods of the gratings ensure a reasonable setup length and clinically relevant image quality. The system is installed in a university hospital and is, therefore, exposed to the external influences of a clinical environment. To demonstrate the system's capabilities, a full-body scan of a euthanized pig was performed. In addition, freshly excised porcine lungs with an extrinsically provoked pneumothorax were mounted into a human thorax phantom and examined with the prototype. Both examination sequences resulted in clinically relevant image quality - even in the case of a skin entrance air kerma of only 0.3 mGy which is in the range of human thoracic imaging. The presented case of a pneumothorax and a reader study showed that the prototype's dark-field images provide added value for pulmonary diagnosis. We demonstrated that a dedicated design of a Talbot-Lau interferometer can be applied to medical imaging by constructing a preclinical Talbot-Lau prototype. We experienced that the system is feasible for imaging human-sized objects and the phase-stepping approach is suitable for clinical practice. Hence, we conclude that Talbot-Lau x-ray imaging has potential for clinical use and enhances the diagnostic power of medical x-ray imaging. © 2018 American Association of Physicists in Medicine.

[Quality control of oral anticoagulant therapy in Primary Care in Madrid City, Spain: CHRONOS-TAO study].

PubMed

Alonso Roca, Rafael; Figueroa Guerrero, Carmen Arlene; Mainar de Paz, Victoria; Arribas García, M Paz; Sánchez Perruca, Luis; Rodríguez Barrientos, Ricardo; Casado López, Mariano; Pedraza Flechas, Ana M

2015-09-07

To determine quality control of patients with oral anticoagulant treatment recruited in Primary Care (PC) using the Rosendaal method to estimate time in therapeutic range (TTR) and comparing it with fraction of international normalized ratio (INR) in range and cross-sectional analysis (last INR registred). A retrospective observational study based on electronic medical record in routine clinical practice. PC centers (262) in Madrid. We included all patients with acenocumarol treatment, with an INR therapeutic range established between 2 and 3. We excluded patients with valvular pathology and disrupted clinical follow up in PC (<3 INR determinations in the studied period, a period of>90 days or ≥ 3 periods of>60 days between 2 determinations). The final population was 49,312 patients. The variables considered were all INR values and their respective dates. TTR was calculated by the 3 methods above mentioned. We considered "therapeutic range" INR between 2-3 and "adjusted range" INR between 1.8-3.2. Optimal control for each patient was considered TTR>60%. By using Rosendaal method, TTR was 66.8% (81.7% adjusted), with a percentage of total INR in range was 58.8% (66.5% adjusted), and, with the cross-sectional analysis, it was 70.5% (76.8% adjusted). Mean TTR was 65% (standard deviation 20.3), and the percentage of patients with TTR>60% was 63.3% (88.1% adjusted). The quality control of patients with oral anticoagulants in PC in Madrid is acceptable, similar or higher to other studies and pivotal trials of new anticoagulants. Compared to the Rosendaal method, total fraction of INR underestimates quality control, and cross-sectional analysis slightly overestimates it. Copyright © 2014 Elsevier España, S.L.U. All rights reserved.

Perceived and insurance-related barriers to the provision of contraceptive services in U.S. abortion care settings.

PubMed

Kavanaugh, Megan L; Jones, Rachel K; Finer, Lawrence B

2011-01-01

Abortion facilities represent a potentially convenient setting for providing contraception to women experiencing unintended pregnancies. This analysis examines a range of factors that may act as barriers to integrating contraceptive and abortion services and documents abortion providers' perspectives on their role in their patients' contraceptive care. Administrators from 173 large, nonhospital facilities that provide abortions in the United States responded to a structured survey between May and September 2009. We used chi-square tests to assess differences in categorical outcomes. Although the majority of U.S. abortion facilities offer a range of contraceptive methods on site, facility staff identified multiple barriers to full integration of the two services, in particular, insurance, patient, and cost barriers. Few of these perceived barriers, however, were associated with differences in the actual provision of most contraceptive methods. Specialized abortion clinics that do not accept health insurance were less likely to have highly effective methods, such as intrauterine devices and implants, on site. Facilities located in Medicaid states were more likely to accept both public and private health insurance for contraceptive services. Increased access to contraceptive services during abortion care is one strategy for reducing repeat unintended pregnancy, and stakeholders at all levels--including abortion providers, insurance companies, and policy makers--have a role to play in achieving this goal. Copyright © 2011 Jacobs Institute of Women's Health. Published by Elsevier Inc. All rights reserved.

The use of real-time elastography in the assessment of gallbladder polyps: preliminary observations.

PubMed

Teber, Mehmet Akif; Tan, Sinan; Dönmez, Uğur; İpek, Ali; Uçar, Ali Erkan; Yıldırım, Halil; Aslan, Ahmet; Arslan, Halil

2014-12-01

Gallbladder polyps often have a benign nature. Current guidelines suggest surgical removal of polyps greater than 10 mm. However, the accuracy of the size criteria is limited because neoplasia can be found in gallbladder polyps less than 10 mm. The aim of this study was to evaluate the feasibility of real time elastography for gallbladder polyps and to demonstrate the elasticity properties of the polyps. Fifty-three polypoid lesions of the gallbladder were prospectively examined with real-time elastography. Of these patients, 52 had a diagnosis of benign gallbladder polyps and one patient was accepted as a gallbladder carcinoma due to its clinical and radiological findings. B-mode and real-time elastographic images were simultaneously presented as a two-panel image, and the elastogram was displayed in a color scale that ranged from red (greatest strain, softest component), to green (average strain, intermediate component), to blue (no strain, hardest component). The mean size for benign gallbladder polyps was 7.2 +/- 3 mm (range, 5-21 mm). All benign gallbladder polyps on consecutive real-time elastographic images appeared as having a high-strain elastographic pattern. Only one patient who was accepted with gallbladder carcinoma had a gallbladder polyp with low elasticity properties. Our study showed that real time elastography of gallbladder polyps is feasible. This novel approach may be useful for the characterization of polypoid lesions of the gallbladder.

A sensitive LC-MS/MS method for the quantification of urinary 8-iso-prostaglandin F2α (8-iso-PGF2α) including pediatric reference interval.

PubMed

Xiao, Yi; Fu, Xiaowei; Pattengale, Paul; Dien Bard, Jennifer; Xu, Yan-Kang; O'Gorman, Maurice R

2016-09-01

Oxidative stress has been implicated in numerous diseases, including arthritis, atherosclerosis, Alzheimer's disease, cancer, diabetes, hypertension, and inflammation. 8-iso-prostaglandin F2α, a member of the F2 isoprostane family, has been well-accepted as a valuable biomarker for the assessment of oxidative stress. We report the development and validation of an ultra-sensitive LC-MS/MS assay for urinary 8-iso-PGF2α measurements in pediatric population. The assay was linear from 0.024 to 20nmol/l (R(2)=0.99). Recoveries were above 85% and matrix effects were below 5%. The variability was determined at nmol/l concentration: the intra-day variability (%CV) ranged from 3.9% to 4.5% (n=20); and the inter-day variability ranged from 4.3% to 5.7% (n=20). The accuracy of our laboratory developed test was evaluated with a clinical reference laboratory (n=39), and a correlation coefficient of 0.9257 was observed. Reference interval were established to be <0.5ng/mg creatinine in a group of pediatric population (2months-18years, n=123). The precision of the assay will allow for accurate assessment of oxidative stress, and is acceptable for patient testing, particularly in pediatric population. Copyright © 2016 Elsevier B.V. All rights reserved.

An acceptance-oriented cognitive-behavioral therapy in multimodal rehabilitation: a pre-post test evaluation in highly distressed patients with rheumatic diseases.

PubMed

Vriezekolk, Johanna E; Eijsbouts, Agnes M M; van Lankveld, Wim G J M; Beenackers, Hanneke; Geenen, Rinie; van den Ende, Cornelia H M

2013-06-01

To examine the potential effectiveness of a multimodal rehabilitation program including an acceptance-oriented cognitive-behavioral therapy for highly distressed patients with rheumatic diseases. An observational study employing a one-group pre-post test design (N=25). The primary outcome was psychological distress. Secondary outcomes were quality of life, illness acceptance, and coping flexibility. Group pre-to-post and pre-to-12 months follow-up treatment changes were evaluated by paired-samples t-tests and Cohen's effect sizes (d). Individual changes were evaluated by the reliable change index (RCI) and clinically significant change (CSC) parameters. Significant effects were found post-treatment and maintained at 12 months in psychological distress (d>0.80), illness acceptance (d=1.48) and the SF-36 subscales role physical, vitality, and mental health (d ≥ 0.65). No significant effects were found for coping flexibility and the SF-36 subscales physical functioning, bodily pain, social functioning, and role emotional. Both a reliable (RCI) and clinically significant (CSC) improvement was observed for almost half of the highly distressed patients. The patients enrolled in the multimodal rehabilitation program showed improved psychological health status from pre to post-treatment. A randomized clinical trial is needed to confirm or refute the added value of an acceptance-oriented cognitive-behavioral therapy for highly distressed patients in rehabilitation. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Evaluation of a novel noninvasive continuous core temperature measurement system with a zero heat flux sensor using a manikin of the human body.

PubMed

Brandes, Ivo F; Perl, Thorsten; Bauer, Martin; Bräuer, Anselm

2015-02-01

Reliable continuous perioperative core temperature measurement is of major importance. The pulmonary artery catheter is currently the gold standard for measuring core temperature but is invasive and expensive. Using a manikin, we evaluated the new, noninvasive SpotOn™ temperature monitoring system (SOT). With a sensor placed on the lateral forehead, SOT uses zero heat flux technology to noninvasively measure core temperature; and because the forehead is devoid of thermoregulatory arteriovenous shunts, a piece of bone cement served as a model of the frontal bone in this study. Bias, limits of agreements, long-term measurement stability, and the lowest measurable temperature of the device were investigated. Bias and limits of agreement of the temperature data of two SOTs and of the thermistor placed on the manikin's surface were calculated. Measurements obtained from SOTs were similar to thermistor values. The bias and limits of agreement lay within a predefined clinically acceptable range. Repeat measurements differed only slightly, and stayed stable for hours. Because of its temperature range, the SOT cannot be used to monitor temperatures below 28°C. In conclusion, the new SOT could provide a reliable, less invasive and cheaper alternative for measuring perioperative core temperature in routine clinical practice. Further clinical trials are needed to evaluate these results.

The efficacy of noninvasive hemoglobin measurement by pulse CO-oximetry in neonates.

PubMed

Jung, Young Hwa; Lee, Juyoung; Kim, Han-Suk; Shin, Seung Han; Sohn, Jin A; Kim, Ee-Kyung; Choi, Jung-Hwan

2013-01-01

To evaluate clinical applicability of noninvasive hemoglobin (Hb) measurement with a pulse CO-oximeter in neonates. Prospective comparison study. Neonatal ICU. Fifty-six preterm and term infants with median age = 20 days (range = 1-98 days) and median weight = 1,440 g (range = 530-4,230 g). Hb measurements by Pulse CO-Oximetry (Masimo Radical-7) were recorded immediately prior to venous samplings. The collected data were compared with the corresponding venous Hb level obtained in laboratory testing, and a total of 137 data pairs were analyzed. Noninvasive Hb values measured with a pulse CO-oximeter were significantly correlated with the venous Hb levels (correlation coefficient, r = 0.758; p < 0.001). Hb values measured with a pulse CO-oximeter were higher than those measured with a laboratory hematology analyzer (13.3 ± 2.6g/dL vs. 12.5 ± 3.1g/dL). In terms of the agreement between the laboratory analyzer and the pulse CO-oximeter, 94.8% of the measurements fell within two standard deviations of the mean difference. Noninvasive Hb measurements with Pulse CO-Oximetry provide clinically acceptable accuracy, and they were significantly correlated with laboratory Hb measurement in neonates. In terms of the clinical applicability, noninvasive Hb monitoring with a pulse CO-oximeter could be useful in the early detection of Hb changes in neonates.

The Association of Shelter Veterinarians' 2016 Veterinary Medical Care Guidelines for Spay-Neuter Programs.

PubMed

Griffin, Brenda; Bushby, Philip A; McCobb, Emily; White, Sara C; Rigdon-Brestle, Y Karla; Appel, Leslie D; Makolinski, Kathleen V; Wilford, Christine L; Bohling, Mark W; Eddlestone, Susan M; Farrell, Kelly A; Ferguson, Nancy; Harrison, Kelly; Howe, Lisa M; Isaza, Natalie M; Levy, Julie K; Looney, Andrea; Moyer, Michael R; Robertson, Sheilah Ann; Tyson, Kathy

2016-07-15

As community efforts to reduce the overpopulation and euthanasia of unwanted and unowned cats and dogs have increased, many veterinarians have increasingly focused their clinical efforts on the provision of spay-neuter services. Because of the wide range of geographic and demographic needs, a wide variety of spay-neuter programs have been developed to increase delivery of services to targeted populations of animals, including stationary and mobile clinics, MASH-style operations, shelter services, community cat programs, and services provided through private practitioners. In an effort to promote consistent, high-quality care across the broad range of these programs, the Association of Shelter Veterinarians convened a task force of veterinarians to develop veterinary medical care guidelines for spay-neuter programs. These guidelines consist of recommendations for general patient care and clinical procedures, preoperative care, anesthetic management, surgical procedures, postoperative care, and operations management. They were based on current principles of anesthesiology, critical care medicine, infection control, and surgical practice, as determined from published evidence and expert opinion. They represent acceptable practices that are attainable in spay-neuter programs regardless of location, facility, or type of program. The Association of Shelter Veterinarians envisions that these guidelines will be used by the profession to maintain consistent veterinary medical care in all settings where spay-neuter services are provided and to promote these services as a means of reducing sheltering and euthanasia of cats and dogs.

Real-Time Clinical Decision Support Decreases Inappropriate Plasma Transfusion.

PubMed

Shah, Neil; Baker, Steven A; Spain, David; Shieh, Lisa; Shepard, John; Hadhazy, Eric; Maggio, Paul; Goodnough, Lawrence T

2017-08-01

To curtail inappropriate plasma transfusions, we instituted clinical decision support as an alert upon order entry if the patient's recent international normalized ratio (INR) was 1.7 or less. The alert was suppressed for massive transfusion and within operative or apheresis settings. The plasma order was automatically removed upon alert acceptance while clinical exception reasons allowed for continued transfusion. Alert impact was studied comparing a 7-month control period with a 4-month intervention period. Monthly plasma utilization decreased 17.4%, from a mean ± SD of 3.40 ± 0.48 to 2.82 ± 0.6 plasma units per hundred patient days (95% confidence interval [CI] of difference, -0.1 to 1.3). Plasma transfused below an INR of 1.7 or less decreased from 47.6% to 41.6% (P = .0002; odds ratio, 0.78; 95% CI, 0.69-0.89). The alert recommendation was accepted 33% of the time while clinical exceptions were chosen in the remaining cases (active bleeding, 31%; other clinical indication, 33%; and apheresis, 2%). Alert acceptance rate varied significantly among different provider specialties. Clinical decision support can help curtail inappropriate plasma use but needs to be part of a comprehensive strategy including audit and feedback for comprehensive, long-term changes. © American Society for Clinical Pathology, 2017. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Protein supplementation with sports protein bars in renal patients.

PubMed

Meade, Anthony

2007-05-01

Malnutrition prevalence in patients on dialysis is well established. The protein requirements for both hemodialysis and peritoneal dialysis have been documented elsewhere, including the Kidney Disease Outcomes Quality Initiative Clinical Practice Guidelines for Nutrition in Chronic Renal Failure. The clinical challenge is to assist patients in meeting these targets, especially in those with anorexia. Traditional supplements have included fluid, which is an issue for patients who are fluid restricted. The study objectives were to (1) investigate the range of sports protein supplements that may be suitable for patients on hemodialysis to use and (2) trial nonfluid protein supplements in patients on hemodialysis. Known manufacturers of sports protein bars and other sports supplements available in Australia were contacted for the nutrient breakdown of high-protein products, specifically potassium, protein, and phosphorus contents. As a result, selected high-protein sports bars (Protein FX, Aussie Bodies, Port Melbourne, Victoria, Australia) were used as an alternative to the more commonly used renal-specific fluid supplements (Nepro, Abbott Laboratories, Abbott Park, IL; Novasource Renal, Novartis Nutrition Corporation, Fremont, MI; and Renilon, Nutricia, Wiltshire, UK) in patients with poor nutritional status requiring supplementation. Patient satisfaction and clinical nutrition markers were investigated. The study took place at inpatient, in-center, and satellite hemodialysis settings in Adelaide, South Australia. A total of 32 patients (16 females and 16 males) with an average age of 62.9 years (range 32-86 years) undergoing hemodialysis (acute and maintenance) were included. Subjects were selected by the author as part of routine clinical nutrition care. Patients trialed sports protein bars as a protein supplement alone or in conjunction with other supplementary products. All patients were in favor of the trial, with 22 of 32 patients continuing with the protein bars as the preferred supplement. The major reasons for not continuing were taste and chewability, especially in older patients with dentures. Serum potassium and phosphate levels were not increased with supplementation. Measured serum albumin and protein catabolic rate were considered unreliable indicators because not all patients were medically stable. Sports protein bars are an acceptable protein and energy supplement for patients on hemodialysis. Sports protein bars are well accepted by patients except when dentures limit chewability. Sports protein bars have advantages over fluid-based supplements in patients with fluid restrictions.

Validity, reliability and responsiveness of the EQ-5D in German stroke patients undergoing rehabilitation.

PubMed

Hunger, Matthias; Sabariego, Carla; Stollenwerk, Björn; Cieza, Alarcos; Leidl, Reiner

2012-09-01

To analyse the psychometric properties of the EQ-5D in German stroke survivors undergoing neurological rehabilitation. The EQ-5D, the Hospital Anxiety and Depression Scale (HADS) and the Stroke Impact Scale (SIS) were completed before (210 subjects) and after (183 subjects) a patient education programme in seven rehabilitation clinics in Bavaria, Germany. A postal follow-up was conducted after 6 months. Acceptance, validity, reliability and responsiveness of the EQ-5D were tested. The SIS subscales were used as external anchors to classify the patients into change groups between the measurements. The proportion of missing answers ranged from 4.7 to 8.6%. Between 16 and 19% reported no problems in any EQ-5D dimension. At baseline, correlations between EQ-5D index and the SIS subscales ranged from 0.15 (communication) to 0.60 (mobility). Correlations with the EQ VAS were slightly smaller. All scores were reliable in test-retest with intraclass correlations ranging from 0.67 to 0.81. EQ-5D index and EQ VAS were consistently responsive only to improvements in health, showing small- to medium effect sizes (0.27-0.42). The EQ-5D has shown reasonable validity, reliability and, more limited, responsiveness in stroke patients with mild to moderate limitations of functional status, allowing it to be used in clinical trials in rehabilitation.

Acceptability of Home-Assessment Post Medical Abortion and Medical Abortion in a Low-Resource Setting in Rajasthan, India. Secondary Outcome Analysis of a Non-Inferiority Randomized Controlled Trial

PubMed Central

Paul, Mandira; Iyengar, Kirti; Essén, Birgitta; Gemzell-Danielsson, Kristina; Iyengar, Sharad D.; Bring, Johan; Soni, Sunita; Klingberg-Allvin, Marie

2015-01-01

Background Studies evaluating acceptability of simplified follow-up after medical abortion have focused on high-resource or urban settings where telephones, road connections, and modes of transport are available and where women have formal education. Objective To investigate women’s acceptability of home-assessment of abortion and whether acceptability of medical abortion differs by in-clinic or home-assessment of abortion outcome in a low-resource setting in India. Design Secondary outcome of a randomised, controlled, non-inferiority trial. Setting Outpatient primary health care clinics in rural and urban Rajasthan, India. Population Women were eligible if they sought abortion with a gestation up to 9 weeks, lived within defined study area and agreed to follow-up. Women were ineligible if they had known contraindications to medical abortion, haemoglobin < 85mg/l and were below 18 years. Methods Abortion outcome assessment through routine clinic follow-up by a doctor was compared with home-assessment using a low-sensitivity pregnancy test and a pictorial instruction sheet. A computerized random number generator generated the randomisation sequence (1:1) in blocks of six. Research assistants randomly allocated eligible women who opted for medical abortion (mifepristone and misoprostol), using opaque sealed envelopes. Blinding during outcome assessment was not possible. Main Outcome Measures Women’s acceptability of home-assessment was measured as future preference of follow-up. Overall satisfaction, expectations, and comparison with previous abortion experiences were compared between study groups. Results 731 women were randomized to the clinic follow-up group (n = 353) or home-assessment group (n = 378). 623 (85%) women were successfully followed up, of those 597 (96%) were satisfied and 592 (95%) found the abortion better or as expected, with no difference between study groups. The majority, 355 (57%) women, preferred home-assessment in the event of a future abortion. Significantly more women, 284 (82%), in the home-assessment group preferred home-assessment in the future, as compared with 188 (70%) of women in the clinic follow-up group, who preferred clinic follow-up in the future (p < 0.001). Conclusion Home-assessment is highly acceptable among women in low-resource, and rural, settings. The choice to follow-up an early medical abortion according to women’s preference should be offered to foster women’s reproductive autonomy. Trial Registration ClinicalTrials.gov NCT01827995 PMID:26327217

What can HIV vaccine trials teach us about future HIV vaccine dissemination?

PubMed Central

Newman, Peter A.; Duan, Naihua; Kakinami, Lisa; Roberts, Kathleen

2008-01-01

Summary This investigation explored commonalities and differences in barriers and motivators to HIV vaccine trial participation and acceptability of future U.S. Food and Drug Administration (FDA)-approved HIV vaccines in order to identify implications of clinical trials for future HIV vaccine dissemination. Fifteen focus groups were conducted with 157 predominately ethnic minority and low income participants recruited using venue-based sampling in Los Angeles. Data were analyzed using narrative thematic analysis. Barriers and motivators in common across willingness to participate (WTP) in HIV vaccine trials and future HIV vaccine acceptability (e.g., concerns about vaccine-induced infection, false-positives, side effects, efficacy, mistrust and stigma) suggest clinical trials present significant opportunities to develop and evaluate empirically based interventions to support future HIV vaccine dissemination. Barriers specific to HIV vaccine acceptability (e.g., concerns about duration of protection, cross-clade protection, cost and access) also indicate the need for formative research focused specifically on future dissemination. Protection motivation, common to WTP and acceptability, highlights the need to provide and evaluate prevention counseling and education in clinical trials, which may form the basis of evidence-informed preventive interventions to be launched in tandem with dissemination of partial efficacy HIV vaccines. PMID:18420313

Safety and acceptability of transcranial direct current stimulation for the acute treatment of major depressive episodes: Analysis of individual patient data.

PubMed

Moffa, Adriano H; Brunoni, André R; Fregni, Felipe; Palm, Ulrich; Padberg, Frank; Blumberger, Daniel M; Daskalakis, Zafiris J; Bennabi, Djamila; Haffen, Emmanuel; Alonzo, Angelo; Loo, Colleen K

2017-10-15

Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation modality that has been increasingly used for major depressive disorder (MDD) treatment. Although studies in healthy volunteers showed that the technique is well-tolerated, tDCS safety and acceptability have not been sufficiently explored in patients with MDD. We collected individual patient data from 6 randomized clinical trials that had been previously identified in a systematic review and meta-analysis. Primary outcomes were safety (rate of adverse events) and acceptability (rate of dropouts). Secondary outcomes were clinical, demographic and treatment predictors of the primary outcomes. Dropout rates between active (8.8%) and sham (12%) groups were not significantly different (OR= 0.7, p=0.38). Adverse event rates between active (73.5%) and sham (68.3%) groups were not significantly different (OR= 1.4, p= 0.23). Higher current densities were associated with lower adverse event rates. Dropout reasons were not systematically reported and adverse events were not collected using questionnaires standardized across studies. Active tDCS is as acceptable and safe as sham tDCS, as found in randomized clinical trials of MDD. Copyright © 2017. Published by Elsevier B.V.

Clomiphene citrate combined with metformin versus letrozole for induction of ovulation in clomiphene-resistant polycystic ovary syndrome: a randomized clinical trial.

PubMed

Rezk, Mohamed; Shaheen, Abd-Elhamid; Saif El-Nasr, Ibrahim

2018-04-01

A total of 202 patients with clomiphene citrate (CC) -resistant polycystic ovary syndrome (PCOS) were randomly allocated into two arms of induction of ovulation; the first group (n = 102) received CC 100 mg and metformin 500 mg while the second group (n = 100) received letrozole 2.5 mg with ovulation rate, clinical pregnancy rate, adverse effects, and acceptability were assessed. Patients in the letrozole arm experienced higher rate of ovulation (82% versus 43.1%, p < .001), more dominant follicles (p < .05), better endometrial thickness (p < .001), higher clinical pregnancy rate (36% versus 9.8%, p < .001), higher multiple pregnancy rate (p < .05), lesser adverse effects (p < .05) and higher acceptability (p < .001) compared to patients in the CC and metformin arm. In conclusion; letrozole is better and more acceptable than combined CC and metformin for inducing ovulation in patients with CC-resistant PCOS with higher clinical pregnancy rate and unexpectedly higher multiple pregnancy rate.

Safety of polyethylene glycol 3350 for the treatment of chronic constipation in children.

PubMed

Pashankar, Dinesh S; Loening-Baucke, Vera; Bishop, Warren P

2003-07-01

To assess the clinical and biochemical safety profile of long-term polyethylene glycol 3350 (PEG) therapy in children with chronic constipation and to assess pediatric patient acceptance of PEG therapy. Prospective observational study. Pediatric clinics at a referral center. Patients Eighty-three children (44 with chronic constipation, 39 with constipation and encopresis) receiving PEG therapy for more than 3 months. Clinical adverse effects related to PEG therapy and acceptance and compliance with PEG therapy. Serum electrolyte levels, osmolality, albumin levels, and liver and renal function test results were measured. At the time of evaluation, the mean duration of PEG therapy was 8.7 months, and the mean PEG dose was 0.75 g/kg daily. There were no major clinical adverse effects. All blood test results were normal, except for transient minimal alanine aminotransferase elevation unrelated to therapy in 9 patients. All children preferred PEG to previously used laxatives, and daily compliance was measured as good in 90% of children. Long-term PEG therapy is safe and is well accepted by children with chronic constipation with and without encopresis.

Fracture reduction and primary ankle arthrodesis: a reliable approach for severely comminuted tibial pilon fracture.

PubMed

Beaman, Douglas N; Gellman, Richard

2014-12-01

Posttraumatic arthritis and prolonged recovery are typical after a severely comminuted tibial pilon fracture, and ankle arthrodesis is a common salvage procedure. However, few reports discuss the option of immediate arthrodesis, which may be a potentially viable approach to accelerate overall recovery in patients with severe fracture patterns. (1) How long does it take the fracture to heal and the arthrodesis to fuse when primary ankle arthrodesis is a component of initial fracture management? (2) How do these patients fare clinically in terms of modified American Orthopaedic Foot and Ankle Society (AOFAS) scores and activity levels after this treatment? (3) Does primary ankle arthrodesis heal in an acceptable position when anterior ankle arthrodesis plates are used? During a 2-year period, we performed open fracture reduction and internal fixation in 63 patients. Eleven patients (12 ankles) with severely comminuted high-energy tibial pilon fractures were retrospectively reviewed after surgical treatment with primary ankle arthrodesis and fracture reduction. Average patient age was 58 years, and minimum followup was 6 months (average, 14 months; range, 6-22 months). Anatomically designed anterior ankle arthrodesis plates were used in 10 ankles. Ring external fixation was used in nine ankles with concomitant tibia fracture or in instances requiring additional fixation. Clinical evaluation included chart review, interview, the AOFAS ankle-hindfoot score, and radiographic evaluation. All of the ankle arthrodeses healed at an average of 4.4 months (range, 3-5 months). One patient had a nonunion at the metaphyseal fracture, which healed with revision surgery. The average AOFAS ankle-hindfoot score was 83 with 88% having an excellent or good result. Radiographic and clinical analysis confirmed a plantigrade foot without malalignment. No patients required revision surgery for malunion. Primary ankle arthrodesis combined with fracture reduction for the severely comminuted tibial pilon fracture reliably healed and restored acceptable function in this highly selective patient group. Ring external fixation may be a useful adjunct to internal fixation, and this concept should be further studied. Level IV, therapeutic study. See Guidelines for Authors for a complete description of levels of evidence.

[Conception and implementation of a novel E-learning module with EbM learning contents in operative dentistry].

PubMed

Gerhardt-Szép, Susanne; Dreher, Stefanie; Rüttermann, Stefan; Weberschock, Tobias

2017-11-01

Computer-assisted learning (CAL) programs are becoming more widely used in medical and dental training. However, the combination of CAL programs and evidence-based education in dentistry has not been described previously. The aim was to determine the acceptance and user-friendliness of a CAL program combined with evidence-based training. The didactic concept of the module includes the case-oriented, problem-based embedding of a total of 32 EbM learning assignments, which can be completed interactively and self-determinedly in an interdisciplinary context using focus patients with different diseases. The present study was conducted at the Dental School of the Goethe University in Frankfurt/Main. Data on acceptance and user-friendliness were collected from three consecutive cohorts of 114 dental students attending their first clinical semester. They used the "Toothache Walk-in Clinic: FOCUS" CAL, which can be downloaded via the Internet. The instrument consisted of 64 statements. The first part addressed general information about the user. The second part contained 43 specific statements on the CAL program. These included factors A (handling and technical aspects), B (content and functional range), and C (didactics and suitability for education). Possible responses ranged from 0 to 3 (0 = strongly disagree, 3 = strongly agree). All of the 114 questionnaires distributed were returned (response rate 100%). Most users (90.1%) considered the topics of evidence-based dentistry important for their training. They rated the program by using German school grades, and the overall rating was 2.26 (SD = 0.64). Most students (88.6%) considered the program useful for their clinical training in the treatment of patients. The mean scores for the 43 specific items amounted to 1.90 (factor A, SD = 0.63), 1.55 (factor B, SD = 1.93), and 2.23 (factor C, SD = 0.79). The CAL program with dental medicine vignettes and learning elements for evidence-based medicine received a primarily positive assessment. Students welcome that EbM contents are offered as part of their dental studies curriculum. Copyright © 2017. Published by Elsevier GmbH.

Efficiency gains for spinal radiosurgery using multicriteria optimization intensity modulated radiation therapy guided volumetric modulated arc therapy planning.

PubMed

Chen, Huixiao; Winey, Brian A; Daartz, Juliane; Oh, Kevin S; Shin, John H; Gierga, David P

2015-01-01

To evaluate plan quality and delivery efficiency gains of volumetric modulated arc therapy (VMAT) versus a multicriteria optimization-based intensity modulated radiation therapy (MCO-IMRT) for stereotactic radiosurgery of spinal metastases. MCO-IMRT plans (RayStation V2.5; RaySearch Laboratories, Stockholm, Sweden) of 10 spinal radiosurgery cases using 7-9 beams were developed for clinical delivery, and patients were replanned using VMAT with partial arcs. The prescribed dose was 18 Gy, and target coverage was maximized such that the maximum dose to the planning organ-at-risk volume (PRV) of the spinal cord was 10 or 12 Gy. Dose-volume histogram (DVH) constraints from the clinically acceptable MCO-IMRT plans were utilized for VMAT optimization. Plan quality and delivery efficiency with and without collimator rotation for MCO-IMRT and VMAT were compared and analyzed based upon DVH, planning target volume coverage, homogeneity index, conformity number, cord PRV sparing, total monitor units (MU), and delivery time. The VMAT plans were capable of matching most DVH constraints from the MCO-IMRT plans. The ranges of MU were 4808-7193 for MCO-IMRT without collimator rotation, 3509-5907 for MCO-IMRT with collimator rotation, 4444-7309 for VMAT without collimator rotation, and 3277-5643 for VMAT with collimator of 90 degrees. The MU for the VMAT plans were similar to their corresponding MCO-IMRT plans, depending upon the complexity of the target and PRV geometries, but had a larger range. The delivery times of the MCO-IMRT and VMAT plans, both with collimator rotation, were 18.3 ± 2.5 minutes and 14.2 ± 2.0 minutes, respectively (P < .05). The MCO-IMRT and VMAT can create clinically acceptable plans for spinal radiosurgery. The MU for MCO-IMRT and VMAT can be reduced significantly by utilizing a collimator rotation following the orientation of the spinal cord. Plan quality for VMAT is similar to MCO-IMRT, with similar MU for both modalities. Delivery times can be reduced by nominally 25% with VMAT. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Adherence and tolerance as key in brake on weight loss in cancer patients with nutritional risk after intervention with a high calorie nutritional and specific hyperproteic supplement

PubMed

García Almeida, Jose M; Lupiáñez Pérez, Yolanda; Blanco Naveira, Mercedes; Ruiz Nava, Josefina; Medina, José Antonio; Cornejo Pareja, Isabel; Gómez Pérez, Ana; Molina Vega, María; López-Medina, José A; Tinahones Madueño, Francisco

2017-06-05

Background: In patients with nutritional risk, the European Society for Clinical Nutrition and Metabolism (ESPEN) recommends nutritional supplements during cancer treatment to prevent weight loss. Objectives: Our goal is to determine the acceptability, compliance and tolerance of a hyperproteic, high-calorie, omega-3 enriched supplement in cancer patients. Methods: Unicentric, prospective observational study in cancer patients with hyperproteic, high-calorie, rich in omega 3 and low volume nutritional supplement. Thirty patients with malnutrition or risk of malnutrition were included. Supplementation lasted six days. Compliance (packaging used), acceptability (Madrid scale), anthropometric variables and gastrointestinal adverse events (AEs) were evaluated. Results: Seventy per cent were men, with an average age of 60 years (range 32-79), with lung (43.3%), ENT (26.7%) and breast neoplasms (13.3%), stage III-IV (56.7%), and treated with radiotherapy (93.3%), chemotherapy (60%) and surgery (16.7%). The product was accepted by all patients. A compliance rate of 100% was observed. Gastrointestinal AE (grade II) related to the supplement was observed in two patients (6.7%). Both subjects had previous gastrointestinal diseases. The median weight, body mass index (BMI) and protein intake increased during supplementation (0.2 kg, 0.1 kg/m2 and 6.2 g). No differences were observed regarding calorie, fat and carbohydrates intake. Conclusion: The high acceptance and compliance with the specific nutritional supplement was associated with an improved nutritional status for cancer patients, and reversed the weight loss without severe gastrointestinal problems, or producing intake displacement.

A Pilot SMART for Developing an Adaptive Treatment Strategy for Adolescent Depression

PubMed Central

Gunlicks-Stoessel, Meredith; Mufson, Laura; Westervelt, Ana; Almirall, Daniel; Murphy, Susan

2015-01-01

Objective(s) This pilot study was conducted to assess the feasibility and acceptability of four adaptive treatment strategies (ATSs) for adolescent depression to plan for a subsequent full-scale clinical trial. The ATSs aim to address two questions that arise when personalizing treatment: (1) for adolescents treated with Interpersonal Psychotherapy for depressed adolescents (IPT-A) (Mufson et al, 2004), at what time point should therapists make the determination that the adolescent is not likely to respond if the initial treatment plan is continued (week 4 or week 8), and (2) for adolescents who are judged to need their treatment augmented, should the therapist increase the number of IPT-A sessions or add pharmacotherapy (fluoxetine). Method A 16 week pilot sequential multiple assignment randomized trial (SMART) was conducted with 32 adolescents (mean age = 14.9) who had a diagnosis of Major Depressive Disorder, Dysthymic Disorder, or Depressive Disorder NOS. Adolescents were primarily female (75%) and Caucasian (84.4%). Data regarding the feasibility and acceptability of the study and treatment procedures and treatment response rates was collected. Results Week 4 was the more feasible and acceptable decision point for assessing need for a change to treatment. Adolescents, parents, and therapists reported a range of attitudes about medication and more intensive therapy as treatment options. Conclusions The ATSs including the week 4 decision point showed promise in terms of their feasibility and acceptability. Results from the pilot study have yielded additional research questions for the full-scale SMART and will improve our ability to successfully conduct the trial. PMID:25785788

The role of physician characteristics in clinical trial acceptance: testing pathways of influence.

PubMed

Curbow, Barbara; Fogarty, Linda A; McDonnell, Karen A; Chill, Julia; Scott, Lisa Benz

2006-03-01

Eight videotaped vignettes were developed that assessed the effects of three physician-related experimental variables (in a 2 x 2 x 2 factorial design) on clinical trial (CT) knowledge, video knowledge, information processing, CT beliefs, affective evaluations (attitudes), and CT acceptance. It was hypothesized that the physician variables (community versus academic-based affiliation, enthusiastic versus neutral presentation of the trial, and new versus previous relationship with the patient) would serve as communication cues that would interrupt message processing, leading to lower knowledge gain but more positive beliefs, attitudes, and CT acceptance. A total of 262 women (161 survivors and 101 controls) participated in the study. The manipulated variables primarily influenced the intermediary variables of post-test CT beliefs and satisfaction with information rather than knowledge or information processing. Multiple regression results indicated that CT acceptance was associated with positive post-CT beliefs, a lower level of information processing, satisfaction with information, and control status. Based on these results, CT acceptance does not appear to be based on a rational decision-making model; this has implications for both the ethics of informed consent and research conceptual models.

[Analysis of the results of the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads].

PubMed

Orta Mira, Nieves; Serrano, María del Remedio Guna; Martínez, José-Carlos Latorre; Ovies, María Rosario; Poveda, Marta; de Gopegui, Enrique Ruiz; Cardona, Concepción Gimeno

2011-12-01

Human immunodeficiency virus type 1 (HIV-1) and hepatitis B (HBV) and C virus (HCV) viral load determinations are among the most important markers for the follow-up of patients infected with these viruses. External quality control tools are crucial to ensure the accuracy of the results obtained by microbiology laboratories. This article summarized the results obtained in the 2010 External Quality Control Program of the Spanish Society of Infectious Diseases and Clinical Microbiology for HIV-1, HCV, and HBV viral loads and HCV genotyping. In the HIV-1 program, a total of five standards were sent. One standard consisted of seronegative human plasma, while the remaining four contained plasma from three different viremic patients, in the range of 3-5 log(10) copies/mL; two of these standards were identical, with the aim of determining repeatability. A significant proportion of the laboratories (22.6% on average) obtained values out of the accepted range (mean ± 0.2 log(10)copies/mL), depending on the standard and on the method used for quantification. Repeatability was very good, with up to 95% of laboratories reporting results within the limits (Δ<0.5 log(10)copies/mL). The HBV and HCV program consisted of two standards with different viral load contents. Most of the participants, 86.1% in the case of HCV and 87.1% in HBV, obtained all the results within the accepted range (mean ± 1.96 SD log(10)UI/mL). Post-analytical errors due to mistranscription of the results were detected in these controls. Data from this analysis reinforce the utility of proficiency programs to ensure the quality of the results obtained by a particular laboratory, as well as the importance of the post-analytical phase in overall quality. Due to interlaboratory variability, use of the same method and the same laboratory for patient follow-up is advisable. Copyright © 2011 Elsevier España S.L. All rights reserved.

Abbreviated Injury Scale: not a reliable basis for summation of injury severity in trauma facilities?

PubMed

Ringdal, Kjetil G; Skaga, Nils Oddvar; Hestnes, Morten; Steen, Petter Andreas; Røislien, Jo; Rehn, Marius; Røise, Olav; Krüger, Andreas J; Lossius, Hans Morten

2013-05-01

Injury severity is most frequently classified using the Abbreviated Injury Scale (AIS) as a basis for the Injury Severity Score (ISS) and the New Injury Severity Score (NISS), which are used for assessment of overall injury severity in the multiply injured patient and in outcome prediction. European trauma registries recommended the AIS 2008 edition, but the levels of inter-rater agreement and reliability of ISS and NISS, associated with its use, have not been reported. Nineteen Norwegian AIS-certified trauma registry coders were invited to score 50 real, anonymised patient medical records using AIS 2008. Rater agreements for ISS and NISS were analysed using Bland-Altman plots with 95% limits of agreement (LoA). A clinically acceptable LoA range was set at ± 9 units. Reliability was analysed using a two-way mixed model intraclass correlation coefficient (ICC) statistics with corresponding 95% confidence intervals (CI) and hierarchical agglomerative clustering. Ten coders submitted their coding results. Of their AIS codes, 2189 (61.5%) agreed with a reference standard, 1187 (31.1%) real injuries were missed, and 392 non-existing injuries were recorded. All LoAs were wider than the predefined, clinically acceptable limit of ± 9, for both ISS and NISS. The joint ICC (range) between each rater and the reference standard was 0.51 (0.29,0.86) for ISS and 0.51 (0.27,0.78) for NISS. The joint ICC (range) for inter-rater reliability was 0.49 (0.19,0.85) for ISS and 0.49 (0.16,0.82) for NISS. Univariate linear regression analyses indicated a significant relationship between the number of correctly AIS-coded injuries and total number of cases coded during the rater's career, but no significant relationship between the rater-against-reference ISS and NISS ICC values and total number of cases coded during the rater's career. Based on AIS 2008, ISS and NISS were not reliable for summarising anatomic injury severity in this study. This result indicates a limitation in their use as benchmarking tools for trauma system performance. Copyright © 2012 Elsevier Ltd. All rights reserved.

Clinical acceptance and accuracy assessment of spinal implants guided with SpineAssist surgical robot: retrospective study.

PubMed

Devito, Dennis P; Kaplan, Leon; Dietl, Rupert; Pfeiffer, Michael; Horne, Dale; Silberstein, Boris; Hardenbrook, Mitchell; Kiriyanthan, George; Barzilay, Yair; Bruskin, Alexander; Sackerer, Dieter; Alexandrovsky, Vitali; Stüer, Carsten; Burger, Ralf; Maeurer, Johannes; Donald, Gordon D; Gordon, Donald G; Schoenmayr, Robert; Friedlander, Alon; Knoller, Nachshon; Schmieder, Kirsten; Pechlivanis, Ioannis; Kim, In-Se; Meyer, Bernhard; Shoham, Moshe

2010-11-15

Retrospective, multicenter study of robotically-guided spinal implant insertions. Clinical acceptance of the implants was assessed by intraoperative radiograph, and when available, postoperative computed tomography (CT) scans were used to determine placement accuracy. To verify the clinical acceptance and accuracy of robotically-guided spinal implants and compare to those of unguided free-hand procedures. SpineAssist surgical robot has been used to guide implants and guide-wires to predefined locations in the spine. SpineAssist which, to the best of the authors' knowledge, is currently the sole robot providing surgical assistance in positioning tools in the spine, guided over 840 cases in 14 hospitals, between June 2005 and June 2009. Clinical acceptance of 3271 pedicle screws and guide-wires inserted in 635 reported cases was assessed by intraoperative fluoroscopy, where placement accuracy of 646 pedicle screws inserted in 139 patients was measured using postoperative CT scans. Screw placements were found to be clinically acceptable in 98% of the cases when intraoperatively assessed by fluoroscopic images. Measurements derived from postoperative CT scans demonstrated that 98.3% of the screws fell within the safe zone, where 89.3% were completely within the pedicle and 9% breached the pedicle by up to 2 mm. The remaining 1.4% of the screws breached between 2 and 4 mm, while only 2 screws (0.3%) deviated by more than 4 mm from the pedicle wall. Neurologic deficits were observed in 4 cases yet, following revisions, no permanent nerve damage was encountered, in contrast to the 0.6% to 5% of neurologic damage reported in the literature. SpineAssist offers enhanced performance in spinal surgery when compared to free-hand surgeries, by increasing placement accuracy and reducing neurologic risks. In addition, 49% of the cases reported herein used a percutaneous approach, highlighting the contribution of SpineAssist in procedures without anatomic landmarks.

Risk-adjusted clinical outcomes in patients enrolled in a bloodless program

PubMed Central

Frank, Steven M.; Wick, Elizabeth C.; Dezern, Amy E.; Ness, Paul M.; Wasey, Jack O.; Pippa, Andrew C.; Dackiw, Elizabeth; Resar, Linda M.S.

2014-01-01

BACKGROUND Although clinical outcomes have been reported for patients who do not accept allogeneic blood transfusion (ABT), many previous studies lack a control group, fail to use risk adjustment, and focus exclusively on cardiac surgery. STUDY DESIGN AND METHODS We report a risk-adjusted, propensity score–matched, retrospective case-control study of clinical outcomes for inpatients who did not accept ABT (bloodless, n = 294) and those who did accept ABT (control, n = 1157). Multidisciplinary specialized care was rendered to the bloodless patients to conserve blood and optimize clinical outcomes. Differences in hemoglobin (Hb), mortality, five morbid outcomes, and hospital charges and costs were compared. Subgroups of medical and surgical patients were analyzed, and independent predictors of outcome were determined by multivariate analysis. RESULTS Overall, mortality was lower in the bloodless group (0.7%) than in the control group (2.7%; p = 0.046), primarily attributed to the surgical subgroup. After risk adjustment, bloodless care was not an independent predictor of the composite adverse outcome (death or any morbid event; p = 0.91; odds ratio, 1.02; 95% confidence interval, 0.68–1.53). Discharge Hb concentrations were similar in the bloodless (10.8 ± 2.7 g/dL) and control (10.9 ± 2.3 g/dL) groups (p = 0.42). Total and direct hospital costs were 12% (p = 0.02) and 18% (p = 0.02) less, respectively, in the bloodless patients, a difference attributed to the surgical subgroup. CONCLUSIONS Using appropriate blood conservation measures for patients who do not accept ABT results in similar or better outcomes and is associated with equivalent or lower costs. This specialized care may be beneficial even for those patients who accept ABT. PMID:24942198

Centralized automated quality assurance for large scale health care systems. A pilot method for some aspects of dental radiography.

PubMed

Benn, D K; Minden, N J; Pettigrew, J C; Shim, M

1994-08-01

President Clinton's Health Security Act proposes the formation of large scale health plans with improved quality assurance. Dental radiography consumes 4% ($1.2 billion in 1990) of total dental expenditure yet regular systematic office quality assurance is not performed. A pilot automated method is described for assessing density of exposed film and fogging of unexposed processed film. A workstation and camera were used to input intraoral radiographs. Test images were produced from a phantom jaw with increasing exposure times. Two radiologists subjectively classified the images as too light, acceptable, or too dark. A computer program automatically classified global grey level histograms from the test images as too light, acceptable, or too dark. The program correctly classified 95% of 88 clinical films. Optical density of unexposed film in the range 0.15 to 0.52 measured by computer was reliable to better than 0.01. Further work is needed to see if comprehensive centralized automated radiographic quality assurance systems with feedback to dentists are feasible, are able to improve quality, and are significantly cheaper than conventional clerical methods.

Decreased Numbers of CD57+CD3- Cells Identify Potential Innate Immune Differences in Patients with Autism Spectrum Disorder.

PubMed

Siniscalco, Dario; Mijatovic, Tatjana; Bosmans, Eugene; Cirillo, Alessandra; Kruzliak, Peter; Lombardi, Vincent C; De Meirleir, Kenny; Antonucci, Nicola

2016-01-01

Autism spectrum disorders (ASD) are complex, and severe heterogeneous neurodevelopmental pathologies with accepted but complex immune system abnormalities. Additional knowledge regarding potential immune dysfunctions may provide a greater understanding of this malady. The aim of this study was to evaluate the CD57(+)CD3(-) mature lymphocyte subpopulation of natural killer cells as a marker of immune dysfunction in ASD. Three-color flow cytometry-based analysis of fresh peripheral blood samples from children with autism was utilized to measure CD57(+)CD3(-) lymphocytes. A reduction of CD57(+)CD3(-) lymphocyte count was recorded in a significant number of patients with autism. We demonstrated that the number of peripheral CD57(+)CD3(-) cells in children with autism often falls below the clinically accepted normal range. This implies that a defect in the counter-regulatory functions necessary for balancing pro-inflammatory cytokines exists, thus opening the way to chronic inflammatory conditions associated with ASD. Copyright © 2016 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

Two Oral Midazolam Preparations in Pediatric Dental Patients: A Prospective Randomised Clinical Trial

PubMed Central

Kamranzadeh, Shaqayegh; Kousha, Maryam; Shaeghi, Shahnaz; AbdollahGorgi, Fatemeh

2015-01-01

Pharmacological sedation is an alternative behavior management strategy in pediatric dentistry. The aim of this study was to compare the behavioral and physiologic effects of “commercially midazolam syrup” versus “orally administered IV midazolam dosage form (extemporaneous midazolam (EF))” in uncooperative pediatric dental patients. Eighty-eight children between 4 to 7 years of age received 0.2–0.5 mg/kg midazolam in this parallel trial. Physiologic parameters were recorded at baseline and every 15 minutes. Behavior assessment was conducted objectively by Houpt scale throughout the sedation and North Carolina at baseline and during injection and cavity preparation. No significant difference in behavior was noted by Houpt or North Carolina scale. Acceptable behavior (excellent, very good, and good) was observed in 90.9% of syrup and 79.5% of EF subjects, respectively. Physiological parameters remained in normal range without significant difference between groups and no adverse effect was observed. It is concluded that EF midazolam preparation can be used as an acceptable alternative to midazolam syrup. PMID:26120325

Impact of tube current modulation on lesion conspicuity index in hi-resolution chest computed tomography

NASA Astrophysics Data System (ADS)

Szczepura, Katy; Tomkinson, David; Manning, David

2017-03-01

Tube current modulation is a method employed in the use of CT in an attempt to optimize radiation dose to the patient. The acceptable noise (noise index) can be varied, based on the level of optimization required; higher accepted noise reduces the patient dose. Recent research [1] suggests that measuring the conspicuity index (C.I.) of focal lesions within an image is more reflective of a clinical reader's ability to perceive focal lesions than traditional physical measures such as contrast to noise (CNR) and signal to noise ratio (SNR). Software has been developed and validated to calculate the C.I. in DICOM images. The aim of this work is assess the impact of tube current modulation on conspicuity index and CTDIvol, to indicate the benefits and limitations of tube current modulation on lesion detectability. Method An anthropomorphic chest phantom was used "Lungman" with inserted lesions of varying size and HU (see table below) a range of Hounsfield units and sizes were used to represent the variation in lesion Hounsfield units found. This meant some lesions had negative Hounsfield unit values.

Acceptance alone is a better predictor of psychopathology and well-being than emotional competence, emotion regulation and mindfulness.

PubMed

Kotsou, Ilios; Leys, Christophe; Fossion, Pierre

2018-01-15

Emotional competence, emotion regulation, mindfulness and acceptance have all been strongly associated to emotional disorders and psychological well-being in multiple studies. However little research has compared the unique predictive ability of these different constructs. We hypothesised that they will all share a large proportion of common variance and that when compared to the broader constructs emotional competence, emotion regulation and mindfulness, acceptance alone would predict a larger proportion of unique variance METHODS: 228 participants from a community sample completed anonymously measures of anxiety, depression, happiness, acceptance, mindfulness, emotional competence and emotion regulation. We then ran multiple regressions to assess and compare the predictive ability of these different constructs. For measures of psychological distress, the acceptance measure uniquely accounted for between 4 and 30 times the variance that the emotional competence, emotion regulation and mindfulness measures did. These results are based on cross-sectional designs and non-clinical samples, longitudinal and experimental studies as clinical samples may be useful in order to assess the potential protective power of acceptance over time. Another limitation is the use of self-report questionnaires. Results confirmed our hypothesis, supporting the research on the importance of acceptance as a central factor in the understanding of the onset and maintenance of emotional disorders. Copyright © 2017 Elsevier B.V. All rights reserved.

Impact of pharmacy student interventions in an urban family medicine clinic.

PubMed

Ginzburg, Regina

2014-06-17

To determine the number of interventions made by pharmacy students at an urban family medicine clinic and the acceptance rate of these recommendations by the healthcare providers. The secondary objective was to investigate the cost avoidance value of the interventions. A prospective, unblinded study was conducted to determine the number and cost avoidance value of clinical interventions made by pharmacy students completing advanced pharmacy practice experiences (APPEs) in an urban family medicine clinic. Eighteen students completed this experience in the 8 months studied. Of the 718 interventions performed, 77% were accepted by physicians, including 58% of the 200 interventions that required immediate action. Projected avoidance was estimated at $61,855. The clinical interventions by pharmacy students were generally well received by healthcare providers and resulted in significant cost savings. Pharmacy students can play an important role in a family medicine clinic.

Treatment acceptability among mexican american parents.

PubMed

Borrego, Joaquin; Ibanez, Elizabeth S; Spendlove, Stuart J; Pemberton, Joy R

2007-09-01

There is a void in the literature with regard to Hispanic parents' views about common interventions for children with behavior problems. The purpose of this study was to examine the treatment acceptability of child management techniques in a Mexican American sample. Parents' acculturation was also examined to determine if it would account for differences in treatment acceptability. Mexican American parents found response cost, a punishment-based technique, more acceptable than positive reinforcement-based techniques (e.g., differential attention). Results suggest that Mexican American parents' acculturation has little impact on acceptability of child management interventions. No association was found between mothers' acculturation and treatment acceptability. However, more acculturated Mexican American fathers viewed token economy as more acceptable than less acculturated fathers. Results are discussed in the context of clinical work and research with Mexican Americans.

DSL prescriptive targets for bone conduction devices: adaptation and comparison to clinical fittings.

PubMed

Hodgetts, William E; Scollie, Susan D

2017-07-01

To develop an algorithm that prescribes targets for bone conduction frequency response shape, compression, and output limiting, along with a clinical method that ensures accurate transforms between assessment and verification stages of the clinical workflow. Technical report of target generation and validation. We recruited 39 adult users of unilateral percutaneous bone conduction hearing aids with a range of unilateral, bilateral, mixed and conductive hearing losses across the sample. The initial algorithm over-prescribed output compared to the user's own settings in the low frequencies, but provided a good match to user settings in the high frequencies. Corrections to the targets were derived and implemented as a low-frequency cut aimed at improving acceptance of the wearer's own voice during device use. The DSL-BCD prescriptive algorithm is compatible with verification of devices and fine-tuning to target for percutaneous bone conduction hearing devices that can be coupled to a skull simulator. Further study is needed to investigate the appropriateness of this prescriptive algorithm for other input levels, and for other clinical populations including those with single-sided deafness, bilateral devices, children and users of transcutaneous bone conduction hearing aids.

A Prospective Evaluation of Helical Tomotherapy

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

Bauman, Glenn; Yartsev, Slav; Rodrigues, George

2007-06-01

Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT inmore » 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.« less

SU-F-I-46: Optimizing Dose Reduction in Adult Head CT Protocols While Maintaining Image Quality in Postmortem Head Scans

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

Lipnharski, I; Carranza, C; Quails, N

Purpose: To optimize adult head CT protocol by reducing dose to an appropriate level while providing CT images of diagnostic quality. Methods: Five cadavers were scanned from the skull base to the vertex using a routine adult head CT protocol (120 kVp, 270 mA, 0.75 s rotation, 0.5 mm × 32 detectors, 70.8 mGy CTDIvol) followed by seven reduced-dose protocols with varying combinations of reduced tube current, reduced rotation time, and increased detectors with CTDIvol ranging from 38.2 to 65.6 mGy. Organ doses were directly measured with 21 OSL dosimeters placed on the surface and implanted in the head bymore » a neurosurgeon. Two neuroradiologists assessed grey-white matter differentiation, fluid space, ventricular size, midline shift, brain mass, edema, ischemia, and skull fractures on a three point scale: (1) Unacceptable, (2) Borderline Acceptable, and (3) Acceptable. Results: For the standard scan, doses to the skin, lens of the eye, salivary glands, thyroid, and brain were 37.55 mGy, 49.65 mGy, 40.67 mGy, 4.63 mGy, and 27.33 mGy, respectively. Two cadavers had cerebral edema due to changing dynamics of postmortem effects, causing the grey-white matter differentiation to appear less distinct. Two cadavers with preserved grey-white matter received acceptable scores for all image quality features for the protocol with a CTDIvol of 57.3 mGy, allowing organ dose savings ranging from 34% to 45%. One cadaver allowed for greater dose reduction for the protocol with a CTDIvol of 42 mGy. Conclusion: Efforts to optimize scan protocol should consider both dose and clinical image quality. This is made possible with postmortem subjects, whose brains are similar to patients, allowing for an investigation of ideal scan parameters. Radiologists at our institution accepted scan protocols acquired with lower scan parameters, with CTDIvol values closer to the American College of Radiology’s (ACR) Achievable Dose level of 57 mGy.« less

Clinical Simulation: A Protocol for Evaluation of Mobile Technology.

PubMed

Mather, Carey; Jensen, Sanne; Cummings, Elizabeth

2017-01-01

For mobile technology to be accepted at point of care in healthcare environments there is a need to demonstrate benefits whilst ameliorating the risks and challenges. To provide a standardised approach to evaluation of mobile technology a simulation protocol was developed to provide guidance for its use in healthcare environments. Simulated conditions provide the opportunity to assess intended and unintended consequences and identify potential workarounds when using technology. The protocol can also be used to demonstrate the importance of the development of digital professionalism by end-users prior to students entering the clinical practice setting. The mobile technology protocol was adapted from a health information systems protocol developed and used at the ITX Lab, Denmark for use in other simulation laboratories. Use case scenarios were developed to enable evaluation of mobile technology for mobile learning of nurses, nurse supervisors, students and patients. The scenarios can be used in a range of simulated environments including hospital bedside, outpatient clinic or community settings. A case study exemplar of a nurse and patient is included to demonstrate how the mobile technology protocol can be applied.

Nanogold-enwrapped graphene nanocomposites as trace labels for sensitivity enhancement of electrochemical immunosensors in clinical immunoassays: Carcinoembryonic antigen as a model.

PubMed

Zhong, Zhaoyang; Wu, Wei; Wang, Dong; Wang, Dan; Shan, Jinlu; Qing, Yi; Zhang, Zhimin

2010-06-15

A new, highly sensitive electrochemical immunosensor with a sandwich-type immunoassay format was designed to quantify carcinoembryonic antigen (CEA), as a model tumor marker, using nanogold-enwrapped graphene nanocomposites (NGGNs) as trace labels in clinical immunoassays. The device consisted of a glassy carbon electrode coated with Prussian Blue (PB) on whose surface gold nanoparticles were electrochemically deposited to the further modified with the specific analyte-capturing molecule, anti-CEA antibodies. The immunoassay was performed using horseradish peroxidase (HRP)-conjugated anti-CEA as secondary antibodies attached on the NGGN surface (HRP-anti-CEA-NGGN). The method using HRP-anti-CEA-NGGNs as detection antibodies shows high signal amplification, and exhibits a dynamic working range of 0.05-350 ng/mL with a low detection limit of 0.01 ng/mL CEA (at 3s). The assayed results of serum samples with the sensor received an acceptable agreement with the reference values. Importantly, the methodology provides a promising ultrasensitive assay strategy for clinical applications. Copyright 2010 Elsevier B.V. All rights reserved.

Nonclinical safety of mavrilimumab, an anti-GMCSF receptor alpha monoclonal antibody, in cynomolgus monkeys: Relevance for human safety

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

Ryan, Patricia C., E-mail: ryanp@medimmune.com; Sleeman, Matthew A.; Rebelatto, Marlon

Mavrilimumab (CAM-3001) is an investigational human IgG4 monoclonal antibody (MAb) targeting GM-CSF receptor alpha which is currently being developed for the treatment of RA. GM-CSF plays a central role in the pathogenesis of rheumatoid arthritis (RA) through the activation, differentiation, and survival of macrophages and neutrophils. To support clinical development, the nonclinical safety of mavrilimumab was evaluated in several studies with cynomolgus monkeys as the pharmacologically relevant species. Comprehensive toxicity parameters were assessed in each study, and treatment duration ranged from 4 to 26 weeks. Mavrilimumab has an acceptable safety profile in monkeys with no changes in any parameters othermore » than microscopic findings in lung. In several studies, minimal accumulation of foamy alveolar macrophages was observed. This finding was only seen in studies of at least 11 weeks duration, was reversible following a dose-free recovery period and was considered non-adverse. At higher dose levels (≥ 30 mg/kg/week), in a 26-week repeat-IV dose study, the presence of lung foreign material, cholesterol clefts, and granulomatous inflammation was also observed in a few animals and was considered adverse. The dose- and time-related accumulation of foamy macrophages in lung following exposure to mavrilimumab observed in several NHP studies was expected based upon the known role of GM-CSFRα signaling in the function of alveolar macrophages. Overall, a clean no-observed-adverse-effect-level (NOAEL) without any effects in lung was established and provided adequate clinical safety margins. In clinical studies in RA patients, mavrilimumab has demonstrated good clinical activity with adequate safety to support further clinical development. A Phase 2b study of mavrilimumab in subjects with RA is in progress. - Highlights: • Mavrilimumab is a MAB targeting GM-CSFRα being developed for RA therapy. • Mavrilimumab has an acceptable safety profile in cynomolgus monkeys. • Lung changes observed reflect role of GM-CSF in alveolar macrophage function. • High safety margins support continued clinical development of mavrilimumab.« less

Formulation, in-vitro characterization and clinical evaluation of curcumin in-situ gel for treatment of periodontitis.

PubMed

Nasra, Maha M A; Khiri, Heba M; Hazzah, Heba A; Abdallah, Ossama Y

2017-11-01

This study aimed to develop syringeable in-situ curcumin (cur) gel for the treatment of periodontal pockets as well as to evaluate the clinical efficacy of Cur in-situ gel formulation. Different in-situ gel formulations of Cur were prepared using 30% of pluronic F127, and 1% of carbopol P934. The formulations were evaluated regarding gelation temperature, pH, viscosity, syringeability study, in-vitro release and chemical stability of cur. The effect of aging of gel formulations for 3months in refrigerator was investigated. The selected formulation was clinically evaluated through the determination of probing depth, plaque index, and bleeding index at baseline and 1 month after application. The formulations showed accepted gelation temperature ranging from 28 to 34 °C and all had pH value of 4. The viscosity of the formulations at 4 °C ranged from 19 000 to 37 000 cP. All formulations were easily syringeable through 21 gauge needle at cold temperature. Curcumin stability during the release study was maintained. Aging showed no significant effect on release profile, drug content, or the pH after 3 months, while it showed a slight increase in viscosity with concomitant decrease in gelation temperature. Selected formulations delivered into periodontal pocket evaluated clinically showed to be effective. The treated group revealed that the adjunctive use of intracrevicular 2% curcumin in-situ gel adjunct to mechanical treatment in patients with adult periodontitis could aid in significant clinical reduction of probing depth, bleeding index, and to less extent of plaque. This indicates that curcumin in this novel drug delivery system is an excellent candidate for periodontal disease treatment.

Critical factors influencing physicians' intention to use computerized clinical practice guidelines: an integrative model of activity theory and the technology acceptance model.

PubMed

Hsiao, Ju-Ling; Chen, Rai-Fu

2016-01-16

With the widespread use of information communication technologies, computerized clinical practice guidelines are developed and considered as effective decision supporting tools in assisting the processes of clinical activities. However, the development of computerized clinical practice guidelines in Taiwan is still at the early stage and acceptance level among major users (physicians) of computerized clinical practice guidelines is not satisfactory. This study aims to investigate critical factors influencing physicians' intention to computerized clinical practice guideline use through an integrative model of activity theory and the technology acceptance model. The survey methodology was employed to collect data from physicians of the investigated hospitals that have implemented computerized clinical practice guidelines. A total of 505 questionnaires were sent out, with 238 completed copies returned, indicating a valid response rate of 47.1 %. The collected data was then analyzed by structural equation modeling technique. The results showed that attitudes toward using computerized clinical practice guidelines (γ = 0.451, p < 0.001), organizational support (γ = 0.285, p < 0.001), perceived usefulness of computerized clinical practice guidelines (γ = 0.219, p < 0.05), and social influence (γ = 0.213, p < 0.05) were critical factors influencing physicians' intention to use computerized clinical practice guidelines, and these factors can explain 68.6 % of the variance in intention to use computerized clinical practice guidelines. This study confirmed that some subject (human) factors, environment (organization) factors, tool (technology) factors mentioned in the activity theory should be carefully considered when introducing computerized clinical practice guidelines. Managers should pay much attention on those identified factors and provide adequate resources and incentives to help the promotion and use of computerized clinical practice guidelines. Through the appropriate use of computerized clinical practice guidelines, the clinical benefits, particularly in improving quality of care and facilitating the clinical processes, will be realized.

Case acceptance: no random acts allowed.

PubMed

McAnally, James

2009-12-01

Consider implementing a case acceptance system in your office to fully utilize your hard-earned clinical skills, and to experience the professional rewards that come with serving more patients at a higher level. Doctors who are willing to commit the time and resources necessary to improving case acceptance will increase the number of implant cases entering the treatment phase--cases that run the gamut of complexity and support fees commensurate with their skills!

Agile Acceptance Test–Driven Development of Clinical Decision Support Advisories: Feasibility of Using Open Source Software

PubMed Central

Baldwin, Krystal L; Kannan, Vaishnavi; Flahaven, Emily L; Parks, Cassandra J; Ott, Jason M; Willett, Duwayne L

2018-01-01

Background Moving to electronic health records (EHRs) confers substantial benefits but risks unintended consequences. Modern EHRs consist of complex software code with extensive local configurability options, which can introduce defects. Defects in clinical decision support (CDS) tools are surprisingly common. Feasible approaches to prevent and detect defects in EHR configuration, including CDS tools, are needed. In complex software systems, use of test–driven development and automated regression testing promotes reliability. Test–driven development encourages modular, testable design and expanding regression test coverage. Automated regression test suites improve software quality, providing a “safety net” for future software modifications. Each automated acceptance test serves multiple purposes, as requirements (prior to build), acceptance testing (on completion of build), regression testing (once live), and “living” design documentation. Rapid-cycle development or “agile” methods are being successfully applied to CDS development. The agile practice of automated test–driven development is not widely adopted, perhaps because most EHR software code is vendor-developed. However, key CDS advisory configuration design decisions and rules stored in the EHR may prove amenable to automated testing as “executable requirements.” Objective We aimed to establish feasibility of acceptance test–driven development of clinical decision support advisories in a commonly used EHR, using an open source automated acceptance testing framework (FitNesse). Methods Acceptance tests were initially constructed as spreadsheet tables to facilitate clinical review. Each table specified one aspect of the CDS advisory’s expected behavior. Table contents were then imported into a test suite in FitNesse, which queried the EHR database to automate testing. Tests and corresponding CDS configuration were migrated together from the development environment to production, with tests becoming part of the production regression test suite. Results We used test–driven development to construct a new CDS tool advising Emergency Department nurses to perform a swallowing assessment prior to administering oral medication to a patient with suspected stroke. Test tables specified desired behavior for (1) applicable clinical settings, (2) triggering action, (3) rule logic, (4) user interface, and (5) system actions in response to user input. Automated test suite results for the “executable requirements” are shown prior to building the CDS alert, during build, and after successful build. Conclusions Automated acceptance test–driven development and continuous regression testing of CDS configuration in a commercial EHR proves feasible with open source software. Automated test–driven development offers one potential contribution to achieving high-reliability EHR configuration. Vetting acceptance tests with clinicians elicits their input on crucial configuration details early during initial CDS design and iteratively during rapid-cycle optimization. PMID:29653922

Agile Acceptance Test-Driven Development of Clinical Decision Support Advisories: Feasibility of Using Open Source Software.

PubMed

Basit, Mujeeb A; Baldwin, Krystal L; Kannan, Vaishnavi; Flahaven, Emily L; Parks, Cassandra J; Ott, Jason M; Willett, Duwayne L

2018-04-13

Moving to electronic health records (EHRs) confers substantial benefits but risks unintended consequences. Modern EHRs consist of complex software code with extensive local configurability options, which can introduce defects. Defects in clinical decision support (CDS) tools are surprisingly common. Feasible approaches to prevent and detect defects in EHR configuration, including CDS tools, are needed. In complex software systems, use of test-driven development and automated regression testing promotes reliability. Test-driven development encourages modular, testable design and expanding regression test coverage. Automated regression test suites improve software quality, providing a "safety net" for future software modifications. Each automated acceptance test serves multiple purposes, as requirements (prior to build), acceptance testing (on completion of build), regression testing (once live), and "living" design documentation. Rapid-cycle development or "agile" methods are being successfully applied to CDS development. The agile practice of automated test-driven development is not widely adopted, perhaps because most EHR software code is vendor-developed. However, key CDS advisory configuration design decisions and rules stored in the EHR may prove amenable to automated testing as "executable requirements." We aimed to establish feasibility of acceptance test-driven development of clinical decision support advisories in a commonly used EHR, using an open source automated acceptance testing framework (FitNesse). Acceptance tests were initially constructed as spreadsheet tables to facilitate clinical review. Each table specified one aspect of the CDS advisory's expected behavior. Table contents were then imported into a test suite in FitNesse, which queried the EHR database to automate testing. Tests and corresponding CDS configuration were migrated together from the development environment to production, with tests becoming part of the production regression test suite. We used test-driven development to construct a new CDS tool advising Emergency Department nurses to perform a swallowing assessment prior to administering oral medication to a patient with suspected stroke. Test tables specified desired behavior for (1) applicable clinical settings, (2) triggering action, (3) rule logic, (4) user interface, and (5) system actions in response to user input. Automated test suite results for the "executable requirements" are shown prior to building the CDS alert, during build, and after successful build. Automated acceptance test-driven development and continuous regression testing of CDS configuration in a commercial EHR proves feasible with open source software. Automated test-driven development offers one potential contribution to achieving high-reliability EHR configuration. Vetting acceptance tests with clinicians elicits their input on crucial configuration details early during initial CDS design and iteratively during rapid-cycle optimization. ©Mujeeb A Basit, Krystal L Baldwin, Vaishnavi Kannan, Emily L Flahaven, Cassandra J Parks, Jason M Ott, Duwayne L Willett. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 13.04.2018.

Does this range suit me? Range satisfaction of battery electric vehicle users.

PubMed

Franke, Thomas; Günther, Madlen; Trantow, Maria; Krems, Josef F

2017-11-01

User satisfaction is a vital design criterion for sustainable systems. The present research aimed to understand factors relating to individually perceived range satisfaction of battery electric vehicle (BEV) users. Data from a large-scale BEV field trial (N = 72) were analyzed. Apart from an initial drop in range satisfaction, increasing practical experience was related to increased range satisfaction. Classical indicators of users' mobility profiles (daily travel distances) were only weakly related to lower range satisfaction (not significant), after controlling for practical experience and preferred coverage of mobility needs. The regularity/predictability of users' mobility patterns, the percentage of journeys not coverable because of range issues, and users' individual comfortable range accounted for variance in range satisfaction. Finally, range satisfaction was related to key indicators of general BEV acceptance (e.g., purchase intentions). These results underline the complex dynamics involved in individual range satisfaction, as well as its central role for BEV acceptance. Copyright © 2017 Elsevier Ltd. All rights reserved.

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

Lucconi, G; Department of Radiation Oncology, Massachusetts General Hospital, Boston, MA; Bentefour, E

Purpose: The clinical commissioning of a workflow for pre-treatment range verification/adjustment for the head treatment of pediatric medulloblastoma patients, including dose monitoring during treatment. Methods: An array of Si-diodes (DIODES Incorporated) is placed on the patient skin on the opposite side to the beam entrance. A “scout” SOBP beam, with a longer beam range to cover the diodes in its plateau, is delivered; the measured signal is analyzed and the extracted water equivalent path lengths (WEPL) are compared to the expected values, revealing if a range correction is needed. Diodes stay in place during treatment to measure dose. The workflowmore » was tested in solid water and head phantoms and validated against independent WEPL measurements. Both measured WEPL and skin doses were compared to computed values from the TPS (XiO); a Markus chamber was used for reference dose measurements. Results: The WEPL accuracy of the method was verified by comparing it with the dose extinction method. It resulted, for both solid water and head phantom, in the sub-millimeter range, with a deviation less than 1% to the value extracted from the TPS. The accuracy of dose measurements in the fall-off part of the dose profile was validated against the Markus chamber. The entire range verification workflow was successfully tested for the mock-treatment of head phantom with the standard delivery of 90 cGy per field per fraction. The WEPL measurement revealed no need for range correction. The dose measurements agreed to better than 4% with the prescription dose. The robustness of the method and workflow, including detector array, hardware set and software functions, was successfully stress-tested with multiple repetitions. Conclusion: The performance of the in-vivo range verification system and related workflow meet the clinical requirements in terms of the needed WEPL accuracy for pretreatment range verification with acceptable dose to the patient.« less

Psychometric properties of the Chinese version of the Obsessive Beliefs Questionnaire-44 (OBQ-44).

PubMed

Wang, Jing; Wei, Zhen; Wang, He; Jiang, Zeyu; Peng, Ziwen

2015-08-04

The Obsessive Beliefs Questionnaire-44 (OBQ-44) is originally developed by the Obsessive Compulsive Cognitions Working Group and has been translated into several languages. This paper is aimed to investigate the psychometric properties of the Chinese version of the Obsessive Beliefs Questionnaire-44 (OBQ-44) in both clinical and non-clinical samples. Five hundred and sixty-nine undergraduate volunteers and sixty-six OCD patients were included in the study. All participants have completed Chinese version of OBQ-44, Yale-Brown Obsessive-Compulsive Scale (Y-BOCS), and Beck Depression Inventory (BDI). Confirmatory factor analysis was conducted to examine the construct validity of Chinese version of OBQ-44. The internal consistency and test-retest reliabilities at 4-week interval were examined in both non-clinical and clinical groups. The confirmatory factor analysis of the non-clinical sample confirmed a 3-factor model which was suggested by the original authors of the instrument (χ (2)/d.f = 2.96, GFI = 0.83, NFI = 0.82, CFI = 0.88 and RMSEA = 0.06). The internal consistency and test-retest reliability were at an acceptable range for the two samples. The Chinese version of OBQ-44 is a valid and reliable instrument for assessing dysfunctional beliefs related to the etiology and maintenance of obsessions and compulsions.

Integrative rehabilitation of elderly stroke survivors: the design and evaluation of the BrightArm™.

PubMed

Rabin, Bryan A; Burdea, Grigore C; Roll, Doru T; Hundal, Jasdeep S; Damiani, Frank; Pollack, Simcha

2012-07-01

To describe the development of the BrightArm upper extremity rehabilitation system, and to determine its clinical feasibility with older hemiplegic patients. The BrightArm adjusted arm gravity loading through table tilting. Patients wore an arm support that sensed grasp strength and communicated wirelessly with a personal computer. Games were written to improve cognitive, psychosocial and the upper extremity motor function and adapted automatically to each patient. The system underwent feasibility trials spanning 6 weeks. Participants were evaluated pre-therapy, post-therapy, and at 6 weeks follow-up using standardized clinical measures. Computerized measures of supported arm reach and game performance were stored on a remote server. Five participants had clinically significant improvements in their active range of shoulder movement, shoulder strength, grasp strength, and their ability to focus. Several participants demonstrated substantially higher arm function (measured with the Fugl-Meyer test) and two were less-depressed (measured with the Becks Depression Inventory, Second Edition). The BrightArm technology was well-accepted by the participants, who gave it an overall subjective rating of 4.1 on a 5 point Likert scale. Given these preliminary findings, it will be beneficial to evaluate the BrightArm through controlled clinical trials and to investigate its application to other clinical populations.

Integrative rehabilitation of elderly stroke survivors: The design and evaluation of the BrightArm™

PubMed Central

Rabin, Bryan A.; Burdea, Grigore C.; Roll, Doru T.; Hundal, Jasdeep S.; Damiani, Frank; Pollack, Simcha

2011-01-01

Purpose To describe the development of the BrightArm upper extremity rehabilitation system, and to determine its clinical feasibility with older hemiplegic patients. Method The BrightArm adjusted arm gravity loading through table tilting. Patients wore an arm support that sensed grasp strength and communicated wirelessly with a personal computer. Games were written to improve cognitive, psychosocial and the upper extremity motor function and adapted automatically to each patient. The system underwent feasibility trials spanning 6 weeks. Participants were evaluated pre-therapy, post-therapy, and at 6 weeks follow-up using standardized clinical measures. Computerized measures of supported arm reach and game performance were stored on a remote server. Results Five participants had clinically significant improvements in their active range of shoulder movement, shoulder strength, grasp strength, and their ability to focus. Several participants demonstrated substantially higher arm function (measured with the Fugl-Meyer test) and two were less-depressed (measured with the Becks Depression Inventory, Second Edition). The BrightArm technology was well-accepted by the participants, who gave it an overall subjective rating of 4.1 on a 5 point Likert scale. Conclusions Given these preliminary findings, it will be beneficial to evaluate the BrightArm through controlled clinical trials and to investigate its application to other clinical populations. PMID:22107353

The Acceptability and Feasibility of Implementing a Bio-Behavioral Enhanced Surveillance Tool for Sexually Transmitted Infections in England: Mixed-Methods Study.

PubMed

Wayal, Sonali; Reid, David; Blomquist, Paula B; Weatherburn, Peter; Mercer, Catherine H; Hughes, Gwenda

2018-05-04

Sexually transmitted infection (STI) surveillance is vital for tracking the scale and pattern of epidemics; however, it often lacks data on the underlying drivers of STIs. This study aimed to assess the acceptability and feasibility of implementing a bio-behavioral enhanced surveillance tool, comprising a self-administered Web-based survey among sexual health clinic attendees, as well as linking this to their electronic health records (EHR) held in England's national STI surveillance system. Staff from 19 purposively selected sexual health clinics across England and men who have sex with men and black Caribbeans, because of high STI burden among these groups, were interviewed to assess the acceptability of the proposed bio-behavioral enhanced surveillance tool. Subsequently, sexual health clinic staff invited all attendees to complete a Web-based survey on drivers of STI risk using a study tablet or participants' own digital device. They recorded the number of attendees invited and participants' clinic numbers, which were used to link survey data to the EHR. Participants' online consent was obtained, separately for survey participation and linkage. In postimplementation phase, sexual health clinic staff were reinterviewed to assess the feasibility of implementing the bio-behavioral enhanced surveillance tool. Acceptability and feasibility of implementing the bio-behavioral enhanced surveillance tool were assessed by analyzing these qualitative and quantitative data. Prior to implementation of the bio-behavioral enhanced surveillance tool, sexual health clinic staff and attendees emphasized the importance of free internet/Wi-Fi access, confidentiality, and anonymity for increasing the acceptability of the bio-behavioral enhanced surveillance tool among attendees. Implementation of the bio-behavioral enhanced surveillance tool across sexual health clinics varied considerably and was influenced by sexual health clinics' culture of prioritization of research and innovation and availability of resources for implementing the surveys. Of the 7367 attendees invited, 85.28% (6283) agreed to participate. Of these, 72.97% (4585/6283) consented to participate in the survey, and 70.62% (4437/6283) were eligible and completed it. Of these, 91.19% (4046/4437) consented to EHR linkage, which did not differ by age or gender but was higher among gay/bisexual men than heterosexual men (95.50%, 722/756 vs 88.31%, 1073/1215; P<.003) and lower among black Caribbeans than white participants (87.25%, 568/651 vs 93.89%, 2181/2323; P<.002). Linkage was achieved for 88.88% (3596/4046) of consenting participants. Implementing a bio-behavioral enhanced surveillance tool in sexual health clinics was feasible and acceptable to staff and groups at STI risk; however, ensuring participants' confidentiality and anonymity and availability of resources is vital. Bio-behavioral enhanced surveillance tools could enable timely collection of detailed behavioral data for effective commissioning of sexual health services. ©Sonali Wayal, David Reid, Paula B Blomquist, Peter Weatherburn, Catherine H Mercer, Gwenda Hughes. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 04.05.2018.

A large-scale mass casualty simulation to develop the non-technical skills medical students require for collaborative teamwork.

PubMed

Jorm, Christine; Roberts, Chris; Lim, Renee; Roper, Josephine; Skinner, Clare; Robertson, Jeremy; Gentilcore, Stacey; Osomanski, Adam

2016-03-08

There is little research on large-scale complex health care simulations designed to facilitate student learning of non-technical skills in a team-working environment. We evaluated the acceptability and effectiveness of a novel natural disaster simulation that enabled medical students to demonstrate their achievement of the non-technical skills of collaboration, negotiation and communication. In a mixed methods approach, survey data were available from 117 students and a thematic analysis undertaken of both student qualitative comments and tutor observer participation data. Ninety three per cent of students found the activity engaging for their learning. Three themes emerged from the qualitative data: the impact of fidelity on student learning, reflexivity on the importance of non-technical skills in clinical care, and opportunities for collaborative teamwork. Physical fidelity was sufficient for good levels of student engagement, as was sociological fidelity. We demonstrated the effectiveness of the simulation in allowing students to reflect upon and evidence their acquisition of skills in collaboration, negotiation and communication, as well as situational awareness and attending to their emotions. Students readily identified emerging learning opportunities though critical reflection. The scenarios challenged students to work together collaboratively to solve clinical problems, using a range of resources including interacting with clinical experts. A large class teaching activity, framed as a simulation of a natural disaster is an acceptable and effective activity for medical students to develop the non-technical skills of collaboration, negotiation and communication, which are essential to team working. The design could be of value in medical schools in disaster prone areas, including within low resource countries, and as a feasible intervention for learning the non-technical skills that are needed for patient safety.

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

PubMed

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

2015-06-01

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

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature.

PubMed

Tofighi, Babak; Nicholson, Joseph M; McNeely, Jennifer; Muench, Frederick; Lee, Joshua D

2017-07-01

Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;36:477-491]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

The influence of program acceptability on the effectiveness of public health policy: a study of directly observed therapy for tuberculosis.

PubMed Central

Heymann, S J; Sell, R; Brewer, T F

1998-01-01

OBJECTIVES: This study examined how patient acceptability influences the effectiveness of directly observed therapy for tuberculosis. METHODS: Decision and sensitivity analyses were used in assessing influences. RESULTS: If mandatory directly observed therapy discourages 6% of initial tuberculosis patients (range: 4% to 10%) from seeking care, then such therapy will be less effective than self-administered therapy. Directly observed therapy is more effective than repeated self-administered therapy for patients failing to complete initial treatment unless 32% (range: 27% to 38%) of patients avoid seeking care. CONCLUSIONS: Patient acceptability must be taken into consideration before selecting public health strategies. PMID:9518978

Estimating the cost-effectiveness of 54 weeks of infliximab for rheumatoid arthritis.

PubMed

Wong, John B; Singh, Gurkirpal; Kavanaugh, Arthur

2002-10-01

To estimate the cost-effectiveness of infliximab plus methotrexate for active, refractory rheumatoid arthritis. We projected the 54-week results from a randomized controlled trial of infliximab into lifetime economic and clinical outcomes using a Markov computer simulation model. Direct and indirect costs, quality of life, and disability estimates were based on trial results; Arthritis, Rheumatism, and Aging Medical Information System (ARAMIS) database outcomes; and published data. Results were discounted using the standard 3% rate. Because most well-accepted medical therapies have cost-effectiveness ratios below $50,000 to $100,000 per quality-adjusted life-year (QALY) gained, results below this range were considered to be "cost-effective." At 3 mg/kg, each infliximab infusion would cost $1393. When compared with methotrexate alone, 54 weeks of infliximab plus methotrexate decreased the likelihood of having advanced disability from 23% to 11% at the end of 54 weeks, which projected to a lifetime marginal cost-effectiveness ratio of $30,500 per discounted QALY gained, considering only direct medical costs. When applying a societal perspective and including indirect or productivity costs, the marginal cost-effectiveness ratio for infliximab was $9100 per discounted QALY gained. The results remained relatively unchanged with variation of model estimates over a broad range of values. Infliximab plus methotrexate for 54 weeks for rheumatoid arthritis should be cost-effective with its clinical benefit providing good value for the drug cost, especially when including productivity losses. Although infliximab beyond 54 weeks will likely be cost-effective, the economic and clinical benefit remains uncertain and will depend on long-term results of clinical trials.

Feasibility and Acceptability of Implementing Indirect Calorimetry Into Routine Clinical Care of Patients With Spinal Cord Injury

PubMed Central

Mayr, Hannah; Atresh, Sridhar; Kemp, Irene; Simmons, Joshua; Vivanti, Angela; Hickman, Ingrid J.

2016-01-01

Background: In the absence of reliable predictive equations, indirect calorimetry (IC) remains the gold standard for assessing energy requirements after spinal cord injury (SCI), but it is typically confined to a research setting. The purpose of this study is to assess the feasibility and acceptability of implementing IC into routine clinical care in an Australian SCI rehabilitation facility. Methods: Bedside IC (canopy hood) was performed, and patients completed an IC acceptability questionnaire (open-ended; yes/no; 5-point Likert scale). Fasted resting energy expenditure (REE) steady-state criteria were applied to assess data quality, and adherence to a test ≥20 minutes was recorded. Staff were surveyed to assess impact of IC on usual care. Results: Of 35 eligible patients, 9 declined (7 reported claustrophobia). One patient could not be tested before discharge and 25 underwent IC (84% male, injury level C2-L2, AIS A-D). Anxiety prevented one patient from completing IC, while another failed to fast. The remaining 23 patients achieved a steady-state REE (≥5 consecutive minutes with ≤10% coefficient of variation for VO2 and VCO2). Test-retest (n = 5) showed <10% variation in REE. Patients deemed the procedure acceptable, with 88% reporting a willingness to repeat IC. Eighty percent of patients and 90% of staff agreed it was acceptable for IC to be integrated into usual care. Conclusion: This study found that IC is a feasible and acceptable addition to the routine clinical care of patients recovering from SCI and may serve to improve accuracy of nutrition interventions for this patient population. PMID:29339868

Dried blood spot analysis for therapeutic drug monitoring of pazopanib.

PubMed

de Wit, Djoeke; den Hartigh, Jan; Gelderblom, Hans; Qian, Yanwen; den Hollander, Margret; Verheul, Henk; Guchelaar, Henk-Jan; van Erp, Nielka P

2015-12-01

Dried blood spot (DBS) sampling is potentially a more patient-friendly and flexible alternative to venous sampling of pazopanib. This study determined the agreement between pazopanib DBS and plasma concentrations to facilitate implementation of pazopanib DBS sampling into clinical practice. Paired DBS and plasma samples were collected in 12 patients. Pazopanib plasma concentrations were calculated from DBS concentrations using the formula: plasma concentration = DBSconcentration /(1 - hematocrit). Passing-Bablok and Bland-Altman analyses were used to determine the agreement between calculated and measured plasma concentrations. We predefined a clinical acceptance limit of 25% for the Bland-Altman analysis. Passing-Bablok analysis showed a small constant (intercept estimate, -8.53 [95%CI, -12.22 to -4.41]) and slightly proportional (slope estimate, 1.15 [95%CI, 1.04-1.24]) bias between calculated and measured concentrations. This bias was clinically nonrelevant, as shown by Bland-Altman analysis; the mean ratio of calculated to measured concentrations was 0.94 (95%CI, 0.65-1.23). The clinical acceptance limits were well within these 95% limits of agreement. More specifically, 92.6% of the data points were within the predefined acceptance limits. Pazopanib plasma concentrations can be accurately calculated from DBS concentrations. Although validation of DBS cards prepared by patients themselves is required, these results show that DBS sampling can be used to monitor pazopanib therapy in clinical practice. © 2015, The American College of Clinical Pharmacology.

An evaluation of a pain education programme for physiotherapists in clinical practice.

PubMed

Monaghan, Jenni; Adams, Nicola; Fothergill, Melissa

2018-03-01

The present study evaluated the implementation and acceptability of a pain education programme delivered to physiotherapists in clinical practice. A pre-test/post-test design with 10 physiotherapists was employed. Descriptive and inferential statistics were used for outcome measure data. Focus groups were carried out with seven physiotherapists within 1 month post-intervention. These data were analysed using the framework approach. Ten musculoskeletal physiotherapists were recruited. It was possible to develop and deliver the intervention and this was found to be acceptable to physiotherapists within clinical practice. The study explored trends within outcome measures, and one was considered appropriate. The focus groups yielded three interlinked themes, which related to the impact of the programme: "providing a context for pain education", "influence on aspects of the patient-therapist encounter" and "logistics of the education programme in clinical practice". A pain education programme delivered to physiotherapists in clinical practice was both possible to deliver and acceptable to participants. A key strength of the programme was the applicability to real-life practice, which was valued by physiotherapists. While physiotherapists felt that pain neurophysiology education was important, they reported lacking confidence in implementing their pain neurophysiology knowledge with patients. Thus, more time is needed to focus on pain neurophysiology education, with the aim of increasing confidence with the application of this approach in clinical practice. Copyright © 2017 John Wiley & Sons, Ltd.

Tolerability, usability and acceptability of dissolving microneedle patch administration in human subjects

PubMed Central

Arya, Jaya; Henry, Sebastien; Kalluri, Haripriya; McAllister, Devin V.; Pewin, Winston P.; Prausnitz, Mark R.

2017-01-01

To support translation of microneedle patches from pre-clinical development into clinical trials, this study examined the effect of microneedle patch application on local skin reactions, reliability of use and acceptability to patients. Placebo patches containing dissolving microneedles were administered to fifteen human participants. Microneedle patches were well tolerated in the skin with no pain or swelling and only mild erythema localized to the site of patch administration that resolved fully within seven days. Microneedle patches could be administered by hand without the need of an applicator and delivery efficiencies were similar for investigator-administration and self-administration. Microneedle patch administration was not considered painful and the large majority of subjects were somewhat or fully confident that they self-administered patches correctly. Microneedle patches were overwhelmingly preferred over conventional needle and syringe injection. Altogether, these results demonstrate that dissolving microneedle patches were well tolerated, easily usable and strongly accepted by human subjects, which will facilitate further clinical translation of this technology. PMID:28285193

Safety analysis of proposed data-driven physiologic alarm parameters for hospitalized children.

PubMed

Goel, Veena V; Poole, Sarah F; Longhurst, Christopher A; Platchek, Terry S; Pageler, Natalie M; Sharek, Paul J; Palma, Jonathan P

2016-12-01

Modification of alarm limits is one approach to mitigating alarm fatigue. We aimed to create and validate heart rate (HR) and respiratory rate (RR) percentiles for hospitalized children, and analyze the safety of replacing current vital sign reference ranges with proposed data-driven, age-stratified 5th and 95th percentile values. In this retrospective cross-sectional study, nurse-charted HR and RR data from a training set of 7202 hospitalized children were used to develop percentile tables. We compared 5th and 95th percentile values with currently accepted reference ranges in a validation set of 2287 patients. We analyzed 148 rapid response team (RRT) and cardiorespiratory arrest (CRA) events over a 12-month period, using HR and RR values in the 12 hours prior to the event, to determine the proportion of patients with out-of-range vitals based upon reference versus data-driven limits. There were 24,045 (55.6%) fewer out-of-range measurements using data-driven vital sign limits. Overall, 144/148 RRT and CRA patients had out-of-range HR or RR values preceding the event using current limits, and 138/148 were abnormal using data-driven limits. Chart review of RRT and CRA patients with abnormal HR and RR per current limits considered normal by data-driven limits revealed that clinical status change was identified by other vital sign abnormalities or clinical context. A large proportion of vital signs in hospitalized children are outside presently used norms. Safety evaluation of data-driven limits suggests they are as safe as those currently used. Implementation of these parameters in physiologic monitors may mitigate alarm fatigue. Journal of Hospital Medicine 2015;11:817-823. © 2015 Society of Hospital Medicine. © 2016 Society of Hospital Medicine.

Contact lens disinfecting solutions antibacterial efficacy: comparison between clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus.

PubMed

Mohammadinia, M; Rahmani, S; Eslami, G; Ghassemi-Broumand, M; Aghazadh Amiri, M; Aghaie, Gh; Tabatabaee, S M; Taheri, S; Behgozin, A

2012-02-01

To evaluate the disinfectant properties of the three multipurpose contact lens disinfecting solutions available in Iran, against clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus, based on the international organization for standardization (ISO) 14729 guidelines. Three multipurpose solutions that were tested were ReNu Multiplus, Solo Care Aqua and All-Clean Soft. The test solutions were challenged with clinical isolates and the standard strains of P. aeruginosa(ATCC 9027) and S. aureus(ATCC 6538), based on the ISO Stand-alone procedure for disinfecting products. Solutions were sampled for surviving microorganisms at manufacturer's minimum recommended disinfection time. The number of viable organisms was determined and log reductions calculated. All of the three test solutions in this study provided a reduction greater than the required mean 3.0 logarithmic reduction against the recommended standard ATCC strains of P. aeruginosa and S. aureus. Antibacterial effectiveness of Solo Care Aqua and All-Clean Soft against clinical isolates of P. aeruginosa and S. aureus were acceptable based on ISO 14729 Stand-alone test. ReNu MultiPlus showed a minimum acceptable efficacy against the clinical isolate of S. aureus, but did not reduce the clinical isolate by the same amount. Although the contact lens disinfecting solutions meet/exceed the ISO 14729 Stand-alone primary acceptance criteria for standard strains of P. aeruginosa and S. aureus, their efficacy may be insufficient against clinical isolates of these organisms.

Contact lens disinfecting solutions antibacterial efficacy: comparison between clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosa and Staphylococcus aureus

PubMed Central

Mohammadinia, M; Rahmani, S; Eslami, G; Ghassemi-Broumand, M; Aghazadh Amiri, M; Aghaie, Gh; Tabatabaee, S M; Taheri, S; Behgozin, A

2012-01-01

Purpose To evaluate the disinfectant properties of the three multipurpose contact lens disinfecting solutions available in Iran, against clinical isolates and the standard ISO ATCC strains of Pseudomonas aeruginosaand Staphylococcus aureus, based on the international organization for standardization (ISO) 14729 guidelines. Methods Three multipurpose solutions that were tested were ReNu Multiplus, Solo Care Aqua and All-Clean Soft. The test solutions were challenged with clinical isolates and the standard strains of P. aeruginosa(ATCC 9027) and S. aureus(ATCC 6538), based on the ISO Stand-alone procedure for disinfecting products. Solutions were sampled for surviving microorganisms at manufacturer's minimum recommended disinfection time. The number of viable organisms was determined and log reductions calculated. Results All of the three test solutions in this study provided a reduction greater than the required mean 3.0 logarithmic reduction against the recommended standard ATCC strains of P. aeruginosaand S. aureus. Antibacterial effectiveness of Solo Care Aqua and All-Clean Soft against clinical isolates of P. aeruginosaand S. aureuswere acceptable based on ISO 14729 Stand-alone test. ReNu MultiPlus showed a minimum acceptable efficacy against the clinical isolate of S. aureus, but did not reduce the clinical isolate by the same amount. Conclusions Although the contact lens disinfecting solutions meet/exceed the ISO 14729 Stand-alone primary acceptance criteria for standard strains of P. aeruginosaand S. aureus, their efficacy may be insufficient against clinical isolates of these organisms. PMID:22094301

Clinically Useful Spirometry in Preschool-Aged Children: Evaluation of the 2007 American Thoracic Society Guidelines

PubMed Central

Gaffin, Jonathan M.; Shotola, Nancy Lichtenberg; Martin, Thomas R.; Phipatanakul, Wanda

2010-01-01

Rationale In 2007 the American Thoracic Society (ATS) recommended guidelines for acceptability and repeatability for assessing spirometry in preschool children. The authors aim to determine the feasibility of spirometry among children in this age group performing spirometry for the first time in a busy clinical practice. Methods First-time spirometry for children age 4 to 5 years old was selected from the Children’s Hospital Boston Pulmonary Function Test (PFT) database. Maneuvers were deemed acceptable if (1) the flow-volume loop showed rapid rise and smooth descent; (2) the back extrapolated volume (Vbe), the volume leaked by a subject prior to the forced maneuver, was ≤80 ml and 12.5% of forced vital capacity (FVC); and (3) cessation of expiratory flow was at a point ≤10% of peak expiratory flow rate (PEFR). Repeatability was determined by another acceptable maneuver with forced expiratory volume in t seconds (FEVt) and FVC within 10% or 0.1 L of the best acceptable maneuver. Post hoc analysis compared spirometry values for those with asthma and cystic fibrosis to normative values. Results Two hundred and forty-eight preschool children performed spirometry for the first time between August 26, 2006, and August 25, 2008. At least one technically acceptable maneuver was found in 82.3% (n = 204) of the tests performed. Overall, 54% of children were able to perform acceptable and repeatable spirometry based on the ATS criteria. Children with asthma or cystic fibrosis did not have spirometry values that differed significantly from healthy controls. However, up to 29% of the overall cohort displayed at least one abnormal spirometry value. Conclusions Many preschool-aged children are able to perform technically acceptable and repeatable spirometry under normal conditions in a busy clinical setting. Spirometry may be a useful screen for abnormal lung function in this age group. PMID:20653495

78 FR 12664 - Human Subject Protection; Acceptance of Data From Clinical Studies for Medical Devices

Federal Register 2010, 2011, 2012, 2013, 2014

2013-02-25

... Clinical Studies for Medical Devices AGENCY: Food and Drug Administration, HHS. ACTION: Proposed rule... data from clinical studies for medical devices. We are proposing to require that clinical studies... the study by an independent ethics committee (IEC) and obtaining and documenting freely given informed...

Benefits of a comprehensive quality program for cryopreserved PBMC covering 28 clinical trials sites utilizing an integrated, analytical web-based portal.

PubMed

Ducar, Constance; Smith, Donna; Pinzon, Cris; Stirewalt, Michael; Cooper, Cristine; McElrath, M Juliana; Hural, John

2014-07-01

The HIV Vaccine Trials Network (HVTN) is a global network of 28 clinical trial sites dedicated to identifying an effective HIV vaccine. Cryopreservation of high-quality peripheral blood mononuclear cells (PBMC) is critical for the assessment of vaccine-induced cellular immune functions. The HVTN PBMC Quality Management Program is designed to ensure that viable PBMC are processed, stored and shipped for clinical trial assays from all HVTN clinical trial sites. The program has evolved by developing and incorporating best practices for laboratory and specimen quality and implementing automated, web-based tools. These tools allow the site-affiliated processing laboratories and the central Laboratory Operations Unit to rapidly collect, analyze and report PBMC quality data. The HVTN PBMC Quality Management Program includes five key components: 1) Laboratory Assessment, 2) PBMC Training and Certification, 3) Internal Quality Control, 4) External Quality Control (EQC), and 5) Assay Specimen Quality Control. Fresh PBMC processing data is uploaded from each clinical site processing laboratory to a central HVTN Statistical and Data Management Center database for access and analysis on a web portal. Samples are thawed at a central laboratory for assay or specimen quality control and sample quality data is uploaded directly to the database by the central laboratory. Four year cumulative data covering 23,477 blood draws reveals an average fresh PBMC yield of 1.45×10(6)±0.48 cells per milliliter of useable whole blood. 95% of samples were within the acceptable range for fresh cell yield of 0.8-3.2×10(6) cells/ml of usable blood. Prior to full implementation of the HVTN PBMC Quality Management Program, the 2007 EQC evaluations from 10 international sites showed a mean day 2 thawed viability of 83.1% and a recovery of 67.5%. Since then, four year cumulative data covering 3338 specimens used in immunologic assays shows that 99.88% had acceptable viabilities (>66%) for use in cellular assays (mean, 91.46% ±4.5%), and 96.2% had acceptable recoveries (50%-130%) with a mean of recovery of 85.8% ±19.12% of the originally cryopreserved cells. EQC testing revealed that since August 2009, failed recoveries dropped from 4.1% to 1.6% and failed viabilities dropped from 1.0% to 0.3%. The HVTN PBMC quality program provides for laboratory assessment, training and tools for identifying problems, implementing corrective action and monitoring for improvements. These data support the benefits of implementing a comprehensive, web-based PBMC quality program for large clinical trials networks. Copyright © 2014 Elsevier B.V. All rights reserved.

The Accuracy of Point-of-Care Glucose Measurements

PubMed Central

Rebel, Annette; Rice, Mark A.; Fahy, Brenda G.

2012-01-01

Control of blood glucose (BG) in an acceptable range is a major therapy target for diabetes patients in both the hospital and outpatient environments. This review focuses on the state of point-of-care (POC) glucose monitoring and the accuracy of the measurement devices. The accuracy of the POC glucose monitor depends on device methodology and other factors, including sample source and collection and patient characteristics. Patient parameters capable of influencing measurements include variations in pH, blood oxygen, hematocrit, changes in microcirculation, and vasopressor therapy. These elements alone or when combined can significantly impact BG measurement accuracy with POC glucose monitoring devices (POCGMDs). In general, currently available POCGMDs exhibit the greatest accuracy within the range of physiological glucose levels but become less reliable at the lower and higher ranges of BG levels. This issue raises serious safety concerns and the importance of understanding the limitations of POCGMDs. This review will discuss potential interferences and shortcomings of the current POCGMDs and stress when these may impact the reliability of POCGMDs for clinical decision-making. PMID:22538154

Opt-out provider-initiated HIV testing and counselling in primary care outpatient clinics in Zambia

PubMed Central

Chipukuma, Julien M; Chiko, Matimba M; Wamulume, Chibesa S; Bolton-Moore, Carolyn; Reid, Stewart E

2011-01-01

Abstract Objective To increase case-finding of infection with human immunodeficiency virus (HIV) in Zambia and their referral to HIV care and treatment by supplementing existing client-initiated voluntary counselling and testing (VCT), the dominant mode of HIV testing in the country. Methods Lay counsellors offered provider-initiated HIV testing and counselling (PITC) to all outpatients who attended primary clinics and did not know their HIV serostatus. Data on counselling and testing were collected in registers. Outcomes of interest included HIV testing coverage, the acceptability of testing, the proportion testing HIV-positive (HIV+), the proportion enrolling in HIV care and treatment and the time between testing and enrolment. Findings After the addition of PITC to VCT, the number tested for HIV infection in the nine clinics was twice the number undergoing VCT alone. Over 30 months, 44 420 patients were counselled under PITC and 31 197 patients, 44% of them men, accepted testing. Of those tested, 21% (6572) were HIV+; 38% of these HIV+ patients (2515) enrolled in HIV care and treatment. The median time between testing and enrolment was 6 days. The acceptability of testing rose over time. Conclusion The introduction of routine PITC using lay counsellors into health-care clinics in Lusaka, Zambia, dramatically increased the uptake and acceptability of HIV testing. Moreover, PITC was incorporated rapidly into primary care outpatient departments. Maximizing the number of patients who proceed to HIV care and treatment remains a challenge and warrants further research. PMID:21556300

Designing a placebo device: involving service users in clinical trial design.

PubMed

Gooberman-Hill, Rachael; Jinks, Clare; Bouças, Sofia Barbosa; Hislop, Kelly; Dziedzic, Krysia S; Rhodes, Carol; Burston, Amanda; Adams, Jo

2013-12-01

Service users are increasingly involved in the design of clinical trials and in product and device development. Service user involvement in placebo development is crucial to a credible and acceptable placebo for clinical trials, but such involvement has not yet been reported. To enhance the design of a future clinical trial of hand splints for thumb-base osteoarthritis (OA), service users were involved in splint selection and design of a placebo splint. This article describes and reflects on this process. Two fora of service users were convened in 2011. Service users who had been prescribed a thumb splint for thumb-base OA were approached about involvement by Occupational Therapy (OT) practitioners. A total of eight service users took part in the fora. Service users discussed their experience of OA and their own splints and then tried a variety of alternative splints. Through this they identified the active features of splints alongside acceptable and unacceptable design features. Service users focused on wearability and support with or without immobilization. Fora discussed whether a placebo group ('arm') was an acceptable feature of a future trial, and service users developed a potential design for a placebo splint. This is the first project that to involve service users in placebo design. Service users are increasingly involved in product and device design and are ideally placed to identify features to make a placebo credible yet lacking key active ingredients. The future trial will include research into its acceptability. © 2013 John Wiley & Sons Ltd.

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya.

PubMed

Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Thomson, Kerry A; Irungu, Elizabeth; Njuguna, Njambi; Mwaniki, Lawrence; Celum, Connie; Baeten, Jared M

2017-02-10

HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing. Clinic visits were scheduled quarterly and included in-clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self-test kits were provided for participants to use in the two-month interval between scheduled quarterly clinic visits. Acceptability of HIV self-testing was assessed using both quantitative and qualitative methods. We found that 222 of 226 (98%) HIV-uninfected persons who were offered accepted self-testing. Nearly all (96.8%) reported that using the self-testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self-testing with anyone and almost all (98.7%) the participants did not share the HIV self-testing kits with anyone. Many participants reported that HIV self-testing was empowering and reduced anxiety associated with waiting between clinic HIV tests. HIV self-testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.

Examining Acceptance of an Integrated Personal Health Record (PHR)

ERIC Educational Resources Information Center

Morton, Alicia A.

2011-01-01

Objective: The purpose of this project was to examine the practice question, "What are the factors influencing acceptance of integrated PHRs for self-care management among the Howard University Hospital (HUH) Diabetes Treatment Clinic (DTC) patients?" These factors include a) demographic characteristics, b) computer…

Seven basic dimensions of personality pathology and their clinical consequences: Are all personalities equally harmful?

PubMed

Vall, Gemma; Gutiérrez, Fernando; Peri, Josep M; Gárriz, Miguel; Ferraz, Liliana; Baillés, Eva; Obiols, Jordi E

2015-11-01

Dimensional pathology models are increasingly being accepted for the assessment of disordered personalities, but their ability to predict negative outcomes is yet to be studied. We examine the relative clinical impact of seven basic dimensions of personality pathology through their associations with a wide range of clinical outcomes. A sample of 960 outpatients was assessed through a 7-factor model integrating the Cloninger, the Livesley, and the DSM taxonomies. Thirty-six indicators of clinical outcome covering three areas - dissatisfaction, functional difficulties, and clinical severity - were also assessed. The unique contribution of each personality dimension to clinical outcome was estimated through multiple regressions. Overall, personality dimensions explained 17.6% of the variance of clinical outcome, but varied substantially in terms of their unique contributions. Negative Emotionality had the greatest impact in all areas, contributing 43.9% of the explained variance. The remaining dimensions led to idiosyncratic patterns of clinical outcomes but had a comparatively minor clinical impact. A certain effect was also found for combinations of dimensions such as Negative Emotionality × Impulsive Sensation Seeking, but most interactions were clinically irrelevant. Our findings suggest that the most relevant dimensions of personality pathology are associated with very different clinical consequences and levels of harmfulness. The relative clinical impact of seven basic dimensions of personality pathology is examined. Negative Emotionality (Neuroticism) is 6-14 times as harmful as other pathological dimensions. The remaining dimensions and their interactions have very specific and comparatively minor clinical consequences. We examine only a handful of clinical outcomes. Our results may not be generalizable to other clinical or life outcomes. Our variables are self-reported and hence susceptible to bias. Our design does not allow us to establish causal relationships between personality and clinical outcomes. © 2015 The British Psychological Society.

Determine feasible and acceptable age 21 support programs

DOT National Transportation Integrated Search

1990-09-01

The objective of this project was to identify programs which are feasible, acceptable, and effective in deterring adolescent drinking. To begin the project, information was collected on 22 prevention programs using a wide range of approaches. Next, a...

Supratentorial Ependymoma: Disease Control, Complications, and Functional Outcomes After Irradiation

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

Landau, Efrat; Boop, Frederick A.; Conklin, Heather M.

Purpose: Ependymoma is less commonly found in the supratentorial brain and has known clinical and molecular features that are unique. Our single-institution series provides valuable information about disease control for supratentorial ependymoma and the complications of supratentorial irradiation in children. Methods and Materials: A total of 50 children with newly diagnosed supratentorial ependymoma were treated with adjuvant radiation therapy (RT); conformal methods were used in 36 after 1996. The median age at RT was 6.5 years (range, 1-18.9 years). The entire group was characterized according to sex (girls 27), race (white 43), extent of resection (gross-total 46), and tumor grademore » (anaplastic 28). The conformal RT group was prospectively evaluated for neurologic, endocrine, and cognitive effects. Results: With a median follow-up time of 9.1 years from the start of RT for survivors (range, 0.2-23.2 years), the 10-year progression-free and overall survival were 73% + 7% and 76% + 6%, respectively. None of the evaluated factors was prognostic for disease control. Local and distant failures were evenly divided among the 16 patients who experienced progression. Eleven patients died of disease, and 1 of central nervous system necrosis. Seizure disorders were present in 17 patients, and 4 were considered to be clinically disabled. Clinically significant cognitive effects were limited to children with difficult-to-control seizures. The average values for intelligence quotient and academic achievement (reading, spelling, and math) were within the range of normal through 10 years of follow-up. Central hypothyroidism was the most commonly treated endocrinopathy. Conclusion: RT may be administered with acceptable risks for complications in children with supratentorial ependymoma. These results suggest that outcomes for these children are improving and that complications may be limited by use of focal irradiation methods.« less

Determination and evaluation of acceptable force limits in single-digit tasks.

PubMed

Nussbaum, Maury A; Johnson, Hope

2002-01-01

Acceptable limits derived from psychophysical methodologies have been proposed, measured, and employed in a range of applications. There is little existing work, however, on such limits for single-digit exertions and relatively limited evidence on several fundamental issues related to data collection and processing of a sequence of self-regulated exertion levels. An experimental study was conducted using 14 male and 10 female participants (age range 18-31 years) from whom maximal voluntary exertions and maximal acceptable limits (MALs) were obtained using the index finger and thumb. Moderate to high levels of consistency were found for both measures between sessions separated by one day. Single MAL values, determined from a time series of exertions, were equivalent across three divergent processing methods and between values obtained from 5- and 25-min samples. A critical interpretation of these and earlier results supports continued use of acceptable limits but also suggests that they should be used with some caution and not equated with safe limits. This research can be applied toward future development of exertion limits based on perceived acceptability.

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up.

PubMed

Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M

2016-01-01

In recent years, direct metal laser sintered (DMLS) metal-ceramic-based fixed partial denture prostheses have been used as an alternative to conventional metal-ceramic fixed partial denture prostheses. However, clinical studies for evaluating their long-term clinical survivability and acceptability are limited. The aim of this study was to assess the efficacy of metal-ceramic fixed dental prosthesis fabricated with DMLS technique, and its clinical acceptance on long-term clinical use. The study group consisted of 45 patients who were restored with posterior three-unit fixed partial denture prosthesis made using direct laser sintered metal-ceramic restorations. Patient recall and clinical examination of the restorations were done after 6months and every 12 months thereafter for the period of 60 months. Clinical examination for evaluation of longevity of restorations was done using modified Ryge criteria which included chipping of the veneered ceramic, connector failure occurring in the fixed partial denture prosthesis, discoloration at the marginal areas of the veneered ceramic, and marginal adaptation of the metal and ceramic of the fixed denture prosthesis. Periapical status was assessed using periodical radiographs during the study period. Survival analysis was made using the Kaplan-Meier method. None of the patients had failure of the connector of the fixed partial denture prostheses during the study period. Two exhibited biological changes which included periapical changes and proximal caries adjacent to the abutments. DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study.

Parent attitudes towards medical student attendance and interaction in the paediatric burns outpatient clinic.

PubMed

Sakata, Shinichiro; McBride, Craig A; Kimble, Roy M

2010-05-01

Medical student attendance in the Outpatient Department is not only essential for the teaching of paediatric burns, but is also important in the recruitment of promising individuals for the growth of our speciality. In 2008, 110 consecutive parents were asked to complete written surveys before the start of their clinic appointment. Only one parent per family could choose to complete the survey. The response rate was 100%. Parents from a diverse range of cultural, educational and socioeconomic were represented in this study. Eighteen parents (16.4%), 48 parents (46.3%) and 44 parents (40.0%) considered their child's burn to be severe, moderate and mild, respectively. One hundred and nine parents (99.1%) accepted the attendance of medical students. Forty-two parents (38.5%) preferred fewer than 3 students, 35 parents (32.1%) would be comfortable with 3-5 medical students and 32 parents (29.4%) could accept more than 6 medical students. One hundred and two parents (92.7%) would allow students to physically interact with their children and 108 parents (99.2%) would allow medical students to freely ask questions in burns clinic. Using logistic regression analysis, we found that high income earners would be comfortable with fewer medical students attending clinic than low income earners (p=0.007). Also, younger parents (p=0.002) and parents from families who made less than A$25,000 a year (p=0.009), believed that they could perceive 'a lot of benefit' from observing medical students being taught, whereas older parents and parents from higher income families responded more often with a perception of only 'some benefit'. This first study in a paediatric outpatient setting shows that parents are overwhelmingly prepared to have medical students involved in the care of their child. Crown Copyright 2009. Published by Elsevier Ltd. All rights reserved.

Stakeholder views of rural community-based medical education: a narrative review of the international literature.

PubMed

Somporn, Praphun; Ash, Julie; Walters, Lucie

2018-03-30

Rural community-based medical education (RCBME), in which medical student learning activities take place within a rural community, requires students, clinical teachers, patients, community members and representatives of health and government sectors to actively contribute to the educational process. Therefore, academics seeking to develop RCBME need to understand the rural context, and the views and needs of local stakeholders. The aim of this review is to examine stakeholder experiences of RCBME programmes internationally. This narrative literature review of original research articles published after 1970 utilises Worley's symbiosis model of medical education as an analysis framework. This model proposes that students experience RCBME through their intersection with multiple clinical, social and institutional relationships. This model seeks to provide a framework for considering the intersecting relationships in which RCBME programmes are situated. Thirty RCBME programmes are described in 52 articles, representing a wide range of rural clinical placements. One-year longitudinal integrated clerkships for penultimate-year students in Anglosphere countries were most common. Such RCBME enables students to engage in work-integrated learning in a feasible manner that is acceptable to many rural clinicians and patients. Academic results are not compromised, and a few papers demonstrate quality improvement for rural health services engaged in RCBME. These programmes have delivered some rural medical workforce outcomes to communities and governments. Medical students also provide social capital to rural communities. However, these programmes have significant financial cost and risk student social and educational isolation. Rural community-based medical education programmes are seen as academically acceptable and can facilitate symbiotic relationships among students, rural clinicians, patients and community stakeholders. These relationships can influence students' clinical competency and professional identity, increase graduates' interest in rural careers, and potentially improve rural health service stability. Formal prospective stakeholder consultations should be published in the literature. © 2018 John Wiley & Sons Ltd and The Association for the Study of Medical Education.

Standardized assessment of tumor-infiltrating lymphocytes in breast cancer: an evaluation of inter-observer agreement between pathologists.

PubMed

Tramm, Trine; Di Caterino, Tina; Jylling, Anne-Marie B; Lelkaitis, Giedrius; Lænkholm, Anne-Vibeke; Ragó, Péter; Tabor, Tomasz P; Talman, Maj-Lis M; Vouza, Emmanouela

2018-01-01

In breast cancer, there is a growing body of evidence that tumor-infiltrating lymphocytes (TILs) may have clinical utility and may be able to direct clinical decisions for subgroups of patients. Clinical utility is, however, not sufficient for warranting the implementation of a new biomarker in the routine practice, and evaluation of the analytical validity is needed, including testing the reproducibility of decentralized assessment of TILs. The aim of this study was to evaluate the inter-observer agreement of TILs assessment using a standardized method, as proposed by the International TILs Working Group 2014, applied to a cohort of breast cancers reflecting an average breast cancer population. Stromal TILs were assessed using full slide sections from 124 breast cancers with varying histology, malignancy grade and ER- and HER2 status. TILs were estimated by nine dedicated breast pathologists using scanned hematoxylin-eosin stainings. TILs results were categorized using various cutoffs, and the inter-observer agreement was evaluated using the intraclass coefficient (ICC), Kappa statistics as well as individual overall agreements with the median value of TILs. Evaluation of TILs led to an ICC of 0.71 (95% CI: 0.65-0.77) corresponding to an acceptable agreement. Kappa values were in the range of 0.38-0.46 corresponding to a fair to moderate agreement. The individual agreements increased, when using only two categories ('high' vs. 'low' TILs) and a cutoff of 50-60%. The results of the present study are in accordance with previous studies, and shows that the proposed methodology for standardized evaluation of TILs renders an acceptable inter-observer agreement. The findings, however, indicate that assessment of TILs needs further refinement, and is in support of the latest St. Gallen Consensus, that routine reporting of TILs for early breast cancer is not ready for implementation in a clinical setting.

A time-motion study of cardiovascular disease risk factor screening integrated into HIV clinic visits in Swaziland.

PubMed

Palma, Anton M; Rabkin, Miriam; Simelane, Samkelo; Gachuhi, Averie B; McNairy, Margaret L; Nuwagaba-Biribonwoha, Harriet; Bongomin, Pido; Okello, Velephi N; Bitchong, Raymond A; El-Sadr, Wafaa M

2018-03-01

Screening of modifiable cardiovascular disease (CVD) risk factors is recommended but not routinely provided for HIV-infected patients, especially in low-resource settings. Potential concerns include limited staff time and low patient acceptability, but little empirical data exists. As part of a pilot study of screening in a large urban HIV clinic in Swaziland, we conducted a time-motion study to assess the impact of screening on patient flow and HIV service delivery and exit interviews to assess patient acceptability. A convenience sample of patients ≥40 years of age attending routine HIV clinic visits was screened for hypertension, diabetes, hyperlipidemia and tobacco smoking. We observed HIV visits with and without screening and measured time spent on HIV and CVD risk factor screening activities. We compared screened and unscreened patients on total visit time and time spent receiving HIV services using Wilcoxon rank-sum tests. A separate convenience sample of screened patients participated in exit interviews to assess their satisfaction with screening. We observed 172 patient visits (122 with CVD risk factor screening and 50 without). Screening increased total visit time from a median (range) of 4 minutes (2 to 11) to 15 minutes (9 to 30) (p < 0.01). Time spent on HIV care was not affected: 4 (2 to 10) versus 4 (2 to 11) (p = 0.57). We recruited 126 patients for exit interviews, all of whom indicated that they would recommend screening to others. Provision of CVD risk factor screening more than tripled the length of routine HIV clinic visits but did not reduce the time spent on HIV services. Programme managers need to take longer visit duration into account in order to effectively integrate CVD risk factor screening and counselling into HIV programmes. © 2018 The Authors. Journal of the International AIDS Society published by John Wiley & sons Ltd on behalf of the International AIDS Society.

The DE-PHARM Project: A Pharmacist-Driven Deprescribing Initiative in a Nursing Facility.

PubMed

Pruskowski, Jennifer; Handler, Steven M

2017-08-01

Many residents with life-limiting illnesses are being prescribed and taking potentially inappropriate medications (PIMs) and questionably beneficial medications either near or at the end of life. These medications can contribute to adverse drug reactions, increase morbidity, and increase unnecessary burden and cost. It is crucial that the process of deprescribing be incorporated into the care of these residents. After developing a clinical pharmacist-driven deprescribing initiative in the nursing facility, the objective of this project was to reduce the number of PIMs via accepted recommendations from the clinical pharmacist to the primary team. The Discussion to Ensure the Patient-centered, Health-focused, prognosis-Appropriate, and Rational Medication regimen (DE-PHARM) quality improvement-approved project was conducted in an urban, academic nursing facility in Pittsburgh, Pennsylvania. The pilot phase occurred between October 2015 and April 2016. To be included in this study, participants had to be a custodial resident of the nursing facility with a previously documented comfort-focused treatment plan. All medications used for the management of chronic comorbid diseases were eligible for review. Forty-seven residents managed by eight different primary teams met inclusion criteria. Thirty-nine recommendations for 23 residents were made by the clinical pharmacist, with an average of 0.82 and range of 0-5 recommendations per resident, respectively. Of those, only 10 (26%) were accepted, 1 (3%) was modified, 3 (7%) were rejected, and 25 (64%) had no response within the 120-day response period. Additionally, two residents died during the project, and one resident was readmitted to the hospital for a prolonged period of time. The pilot phase of the DE-PHARM project, a clinical pharmacist-driven deprescribing initiative, was designed and assessed. This project demonstrated the feasibility of such an initiative. Because of the complexity of such a process, special attention must be paid to eligible residents and medications, the need for interprofessional collaboration, and the operational process. This project is ongoing in other nursing facilities in Western Pennsylvania.

MO-DE-BRA-03: The Ottawa Medical Physics Institute (OMPI): A Practical Model for Academic Program Collaboration in a Multi-Centre City

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

McEwen, M; Rogers, D; Johns, P

Purpose: To build a world-class medical physics educational program that capitalizes on expertise distributed over several clinical, government, and academic centres. Few if any of these centres would have the critical mass to solely resource a program. Methods: In order to enable an academic program, stakeholders from five institutions made a proposal to Carleton University for a) a research network with defined membership requirements and a process for accepting new members, and b) a graduate specialization (MSc and PhD) in medical physics. Both proposals were accepted and the program has grown steadily. Our courses are taught by medical physicists frommore » across the collaboration. Our students have access to physicists in: clinical radiotherapy (the Ottawa Cancer Centre treats 4500 new patients/y), radiology, cardiology and nuclear medicine, Canada’s primary standards dosimetry laboratory, radiobiology, and university-based medical physics research. Our graduate courses emphasize the foundational physics plus applied aspects of imaging, radiotherapy, and radiobiology. Active researchers in the city-wide volunteer-run network are appointed as adjunct professors by Physics, giving them access to national funding competitions and partial student funding through teaching assistantships while opening up facilities in their institutions for student thesis research. Results: The medical physics network has grown to ∼40 members from eight institutions and includes five full-time faculty in Physics and 17 adjunct research professors. The graduate student population is ∼20. Our graduates have proceeded to a spectrum of careers. Our alumni list includes a CCPM Past-President, the current COMP President, many clinical physicists, and the heads of at least three major clinical medical physics departments. Our PhD was Ontario’s first CAMPEP-accredited program. Conclusion: A self-governing volunteer network is the foundational element that enables an MSc/PhD medical physics program in a city with multiple physicist employers. It enriches graduate education with an unusually broad range of expertise.« less

Acceptance of standardized ultrasound classification, use of albendazole, and long-term follow-up in clinical management of cystic echinococcosis: a systematic review.

PubMed

Tamarozzi, Francesca; Nicoletti, Giovanni J; Neumayr, Andreas; Brunetti, Enrico

2014-10-01

Cystic echinococcosis is a chronic, complex, and neglected disease. The need for a simple classification of cyst morphology that would provide an accepted framework for scientific and clinical work on cystic echinococcosis has been addressed by two documents issued by the WHO Informal Working Group on Echinococcosis in 2003 (cyst classification) and in 2010 (Expert consensus for the diagnosis and treatment of echinococcosis). Here we evaluate the use of the WHO Informal Working Group on Echinococcosis classification of hepatic cystic echinococcosis, the acceptance by clinicians of recommendations regarding the use of albendazole, and the implementation of the long-term follow-up of patients with hepatic cystic echinococcosis in the scientific literature since the WHO Informal Working Group on Echinococcosis recommendations were issued. Of the publications included in our review, 71.2% did not indicate any classification, whereas 14% used the WHO Informal Working Group on Echinococcosis classification. Seventy-four percent reported the administration of peri-interventional albendazole, although less than half reported its modality, and 51% the length of patient follow-up. A joint effort is needed from the scientific community to encourage the acceptance and implementation of these three key issues in the clinical management of cystic echinococcosis.

Contributing factors to VEP grating acuity deficit and inter-ocular acuity difference in children with cerebral visual impairment.

PubMed

Cavascan, Nívea Nunes; Salomão, Solange Rios; Sacai, Paula Yuri; Pereira, Josenilson Martins; Rocha, Daniel Martins; Berezovsky, Adriana

2014-04-01

To investigate contributing factors to visual evoked potential (VEP) grating acuity deficit (GAD) and inter-ocular acuity difference (IAD) measured by sweep-VEPs in children with cerebral visual impairment (CVI). VEP GAD was calculated for the better acuity eye by subtracting acuity thresholds from mean normal VEP grating acuity according to norms from our own laboratory. Deficits were categorized as mild (0.17 ≤ deficit < 0.40 log units), moderate (0.40 ≤ deficit < 0.70 log units) or severe (deficit ≥0.70 log units). Maximum acceptable IAD was 0.10 log units. A group of 115 children (66 males-57 %) with ages ranging from 1.2 to 166.5 months (median = 17.7) was examined. VEP GAD ranged from 0.17 to 1.28 log units (mean = 0.68 ± 0.27; median = 0.71), and it was mild in 23 (20 %) children, moderate in 32 (28 %) and severe in 60 (52 %). Severe deficit was significantly associated with older age and anti-seizure drug therapy. IAD ranged from 0 to 0.49 log units (mean = 0.06 ± 0.08; median = 0.04) and was acceptable in 96 (83 %) children. Children with strabismus and nystagmus had IAD significantly larger compared to children with orthoposition. In a large cohort of children with CVI, variable severity of VEP GAD was found, with more than half of the children with severe deficits. Older children and those under anti-seizure therapy were at higher risk for larger deficits. Strabismus and nystagmus provided larger IADs. These results should be taken into account on the clinical management of children with this leading cause of bilateral visual impairment.

An alternative sensor-based method for glucose monitoring in children and young people with diabetes

PubMed Central

Edge, Julie; Acerini, Carlo; Campbell, Fiona; Hamilton-Shield, Julian; Moudiotis, Chris; Rahman, Shakeel; Randell, Tabitha; Smith, Anne; Trevelyan, Nicola

2017-01-01

Objective To determine accuracy, safety and acceptability of the FreeStyle Libre Flash Glucose Monitoring System in the paediatric population. Design, setting and patients Eighty-nine study participants, aged 4–17 years, with type 1 diabetes were enrolled across 9 diabetes centres in the UK. A factory calibrated sensor was inserted on the back of the upper arm and used for up to 14 days. Sensor glucose measurements were compared with capillary blood glucose (BG) measurements. Sensor results were masked to participants. Results Clinical accuracy of sensor results versus BG results was demonstrated, with 83.8% of results in zone A and 99.4% of results in zones A and B of the consensus error grid. Overall mean absolute relative difference (MARD) was 13.9%. Sensor accuracy was unaffected by patient factors such as age, body weight, sex, method of insulin administration or time of use (day vs night). Participants were in the target glucose range (3.9–10.0 mmol/L) ∼50% of the time (mean 12.1 hours/day), with an average of 2.2 hours/day and 9.5 hours/day in hypoglycaemia and hyperglycaemia, respectively. Sensor application, wear/use of the device and comparison to self-monitoring of blood glucose were rated favourably by most participants/caregivers (84.3–100%). Five device related adverse events were reported across a range of participant ages. Conclusions Accuracy, safety and user acceptability of the FreeStyle Libre System were demonstrated for the paediatric population. Accuracy of the system was unaffected by subject characteristics, making it suitable for a broad range of children and young people with diabetes. Trial registration number NCT02388815. PMID:28137708

Technical feasibility of laparoscopic total gastrectomy with splenectomy for gastric cancer: clinical short-term and long-term outcomes.

PubMed

Nakata, Kohei; Nagai, Eishi; Ohuchida, Kenoki; Shimizu, Shuji; Tanaka, Masao

2015-07-01

Since its widespread acceptance for the treatment of early gastric cancer, laparoscopic gastrectomy has been gaining popularity as a treatment option for advanced gastric cancer. However, laparoscopic total gastrectomy (LTG) with splenectomy is seldom performed, because of its difficulty of removal of station 10 lymph nodes; splenectomy is technically essential for complete removal of these lymph nodes. The purpose of this study was to describe the details of the LTG procedure and to evaluate the short- and long-term outcomes of LTG with splenectomy. Of 725 consecutive patients with gastric cancer who underwent laparoscopic gastrectomy with lymph node dissection in our institution from January 1996 to December 2012, 18 consecutive patients who underwent LTG with splenectomy were enrolled in this study. No operative mortality occurred, and the pathological margins were free from cancer cells in all patients. The mean operation time was 388 min (range 324-566 min). The mean volume of blood loss was 45 ml (range 5-347 ml), and the mean number of dissected lymph nodes was 51 (range 40-105). Postoperative morbidity occurred in six patients (33.3%) (each with grade B postoperative pancreatic fistula, postoperative bleeding, chylous ascites, atelectasis, ileus, and intra-abdominal infection). Five patients (27.8%) developed recurrence (four in the peritoneum and one in the liver), and the overall 3- and 5-year survival rates were 83.0 and 72.6%, respectively. Considering the 0% mortality rate and low rates of postoperative morbidity and locoregional recurrence, LTG with splenectomy is technically and oncologically acceptable. This procedure can be expanded to include advanced gastric cancer, which generally requires splenectomy for lymph node dissection.

Monitored Natural Attenuation and Enhanced Attenuation for Chlorinated Solvent Plumes - It’s All About Balance

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

VANGELAS, KAREN

2005-05-19

Nature's inherent ability to cleanse itself is at the heart of Monitored Natural Attenuation (MNA). The complexity comes when one attempts to measure and calculate this inherent ability, called the Natural Attenuation Capacity (NAC), and determine if it is sufficient to cleanse the system to agreed upon criteria. An approach that is simple in concept for determining whether the NAC is sufficient for MNA to work is the concept of a mass balance. Mass balance is a robust framework upon which all decisions can be made. The inflows to and outflows from the system are balanced against the NAC ofmore » the subsurface system. For MNA to be acceptable, the NAC is balanced against the contaminant loading to the subsurface system with the resulting outflow from the system being in a range that is acceptable to the regulating and decision-making parties. When the system is such that the resulting outflow is not within an acceptable range, the idea of taking actions that are sustainable and that will bring the system within the acceptable range of outflows is evaluated. These sustainable enhancements are being developed under the Enhanced Attenuation (EA) concept.« less

Monitored natural attenuation and enhanced attenuation for chlorinated solvent plumes - It's all about balance

USGS Publications Warehouse

Adams, K.A.; Vangelas, K.M.; Looney, B.B.; Chapelle, F.; Early, T.; Gilmore, T.; Sink, C.H.

2005-01-01

Nature's inherent ability to cleanse itself is at the heart of Monitored Natural Attenuation (MNA). The complexity comes when one attempts to measure and calculate this inherent ability, called the Natural Attenuation Capacity (NAC), and determine if it is sufficient to cleanse the system to agreed upon criteria. An approach that is simple in concept for determining whether the NAC is sufficient for MNA to work is the concept of a mass balance. Mass balance is a robust framework upon which all decisions can be made. The inflows to and outflows from the system are balanced against the NAC of the subsurface system. For MNA to be acceptable, the NAC is balanced against the contaminant loading to the subsurface system with the resulting outflow from the system being in a range that is acceptable to the regulating and decision-making parties. When the system is such that the resulting outflow is not within an acceptable range, the idea of taking actions that are sustainable and that will bring the system within the acceptable range of outflows is evaluated. These sustainable enhancements are being developed under the Enhanced Attenuation (EA) concept. Copyright ASCE 2005.

Current Approaches and Clinician Attitudes to the Use of Cerebrospinal Fluid Biomarkers in Diagnostic Evaluation of Dementia in Europe.

PubMed

Miller, Anne-Marie; Balasa, Mircea; Blennow, Kaj; Gardiner, Mary; Rutkowska, Aleksandra; Scheltens, Philip; Teunissen, Charlotte E; Visser, Pieter Jelle; Winblad, Bengt; Waldemar, Gunhild; Lawlor, Brian

2017-01-01

BIOMARKAPD seeks to diminish the barriers associated with the clinical use of cerebrospinal fluid (CSF) biomarker analysis by reducing variation in CSF laboratory methodologies and generating consensus recommendations on their clinical interpretation and application for dementia diagnosis. To examine the disparity in practitioner attitudes and clinical practice relating to the use of CSF biomarkers for dementia diagnosis across Europe. Clinical dementia experts were surveyed on the prevalence of national consensus guidelines and analytical reimbursement across Europe, their biomarker platform preferences, lumbar puncture methodologies and application of reference values and cut-offs for CSF analysis. 74% of respondents (total n = 51) use CSF biomarkers in clinical practice and 69% perform lumbar punctures on an outpatient basis. Most use CSF biomarkers to diagnose atypical (84%) and early-onset cases of cognitive impairment (71%) and for the differential diagnosis of other dementias (69%). 82% state they are sufficiently informed about CSF biomarkers yet 61% report a lack of national consensus guidelines on their use for dementia diagnosis. 48% of countries represented do not reimburse clinical CSF analysis costs. 43% report using normal reference ranges derived from publications. Variations in attitude and practice relating to CSF biomarkers, widely recognised as barriers to their clinical acceptance, remain evident within and between countries across Europe, even in expert centres. These shortcomings must be addressed by developing consensus guidelines on CSF-related methodologies and their clinical application, to further their use for the diagnostic evaluation of dementia.

Chronic Effects of Mild Neurotrauma: Putting the Cart Before the Horse?

PubMed Central

Castellani, Rudy J.; Perry, George; Iverson, Grant L.

2015-01-01

Accumulation of phosphorylated tau (p-tau) is accepted by many as a long-term consequence of repetitive mild neurotrauma, based largely on brain findings in boxers (dementia pugilistica) and, more recently, former professional athletes, military service members, and others exposed to repetitive head trauma. The pathogenic construct is also largely accepted and suggests that repetitive head trauma (typically concussions or subconcussive forces) acts on brain parenchyma to produce a deleterious neuroinflammatory cascade, encompassing p-tau templating, trans-synaptic neurotoxicity, progressive neurodegenerative disease, and associated clinical features. Some caution before accepting these concepts and assumptions is warranted, however. The association between history of concussion and findings of p-tau at autopsy is unclear. Concussions and subconcussive head trauma exposure are poorly defined in available cases and the clinical features reported in CTE are not at present distinguishable from other disorders. Because control groups are limited, the idea that p-tau drives the disease process via protein templating or some other mechanism is preliminary. Much additional research in CTE is needed to determine if it has unique neuropathology and clinical features, the extent to which the neuropathologic alterations cause the clinical features, and whether it can be identified accurately in a living person. PMID:25933385

Acceptability of general practice services for Afghan refugees in south-eastern Melbourne.

PubMed

Manchikanti, Prashanti; Cheng, I-Hao; Advocat, Jenny; Russell, Grant

2017-04-01

Over 750000 refugees have resettled in Australia since 1945. Despite complex health needs related to prior traumatic experiences and the challenges of resettlement in a foreign country, refugees experience poor access to primary care. Health and settlement service providers describe numerous cultural, communication, financial and health literacy barriers. This study aimed to investigate the acceptability of general practitioner (GP) services and understand what aspects of acceptability are relevant for Afghan refugees in south-eastern Melbourne. Semi-structured interviews were conducted with two Afghan community leaders and 16 Dari- or English-speaking Afghan refugees who accessed GP services. Two distinct narratives emerged - those of recently arrived refugees and established refugees (living in Australia for 3 years or longer). Transecting these narratives, participants indicated the importance of: (1) a preference for detailed clinical assessments, diagnostic investigations and the provision of prescriptions at the first consultation; (2) 'refugee-friendly' staff; and (3) integrated, 'one-stop-shop' GP clinic features. The value of acceptable personal characteristics evolved over time - GP acceptability was less a consideration for recently arrived, compared with more, established refugees. The findings reinforce the importance of tailoring healthcare delivery to the evolving needs and healthcare expectations of newly arrived and established refugees respectively.

Tolerability and cosmetic acceptability of liquor carbonis distillate (coal tar) solution 15% as topical therapy for plaque psoriasis.

PubMed

Brouda, Irina; Edison, Brenda; Van Cott, Alicia; Green, Barbara A

2010-04-01

Although generally recognized as an effective therapy for psoriasis, coal tar therapy lost appeal in modern clinical practice due to poor patient acceptability of its aesthetic properties. A new liquor carbonis distillate (LCD) solution 15% (equivalent to coal tar 2.3%) that uses an evaporative and transparent vehicle, fragrance, and a dab-on applicator was developed. Cosmetic acceptability of the LCD solution was compared to calcipotriene cream 0.005% during a randomized, active-controlled, investigator-blinded clinical trial. Participants with moderate plaque psoriasis applied LCD solution or calcipotriene cream twice daily to body lesions for 12 weeks and then were followed for 6 additional weeks without treatment. Participants completed a cosmetic acceptability survey about their medications after starting therapy. Mean ratings for aesthetic and product performance attributes were high in both groups; however, more participants treated with LCD solution versus calcipotriene cream rated their product as more convenient and beneficial compared to prior psoriasis therapies. Ratings of the scent, staining, drying time, and dab-on applicator for the LCD solution were favorable. Participant experience with LCD solution in this study suggests that it is a cosmetically acceptable psoriasis treatment that is comparable to calcipotriene cream.

Direct Observation of Clinical Skills Feedback Scale: Development and Validity Evidence.

PubMed

Halman, Samantha; Dudek, Nancy; Wood, Timothy; Pugh, Debra; Touchie, Claire; McAleer, Sean; Humphrey-Murto, Susan

2016-01-01

Construct: This article describes the development and validity evidence behind a new rating scale to assess feedback quality in the clinical workplace. Competency-based medical education has mandated a shift to learner-centeredness, authentic observation, and frequent formative assessments with a focus on the delivery of effective feedback. Because feedback has been shown to be of variable quality and effectiveness, an assessment of feedback quality in the workplace is important to ensure we are providing trainees with optimal learning opportunities. The purposes of this project were to develop a rating scale for the quality of verbal feedback in the workplace (the Direct Observation of Clinical Skills Feedback Scale [DOCS-FBS]) and to gather validity evidence for its use. Two panels of experts (local and national) took part in a nominal group technique to identify features of high-quality feedback. Through multiple iterations and review, 9 features were developed into the DOCS-FBS. Four rater types (residents n = 21, medical students n = 8, faculty n = 12, and educators n = 12) used the DOCS-FBS to rate videotaped feedback encounters of variable quality. The psychometric properties of the scale were determined using a generalizability analysis. Participants also completed a survey to gather data on a 5-point Likert scale to inform the ease of use, clarity, knowledge acquisition, and acceptability of the scale. Mean video ratings ranged from 1.38 to 2.96 out of 3 and followed the intended pattern suggesting that the tool allowed raters to distinguish between examples of higher and lower quality feedback. There were no significant differences between rater type (range = 2.36-2.49), suggesting that all groups of raters used the tool in the same way. The generalizability coefficients for the scale ranged from 0.97 to 0.99. Item-total correlations were all above 0.80, suggesting some redundancy in items. Participants found the scale easy to use (M = 4.31/5) and clear (M = 4.23/5), and most would recommend its use (M = 4.15/5). Use of DOCS-FBS was acceptable to both trainees (M = 4.34/5) and supervisors (M = 4.22/5). The DOCS-FBS can reliably differentiate between feedback encounters of higher and lower quality. The scale has been shown to have excellent internal consistency. We foresee the DOCS-FBS being used as a means to provide objective evidence that faculty development efforts aimed at improving feedback skills can yield results through formal assessment of feedback quality.

Staying well during pregnancy and the postpartum: A pilot randomized trial of mindfulness-based cognitive therapy for the prevention of depressive relapse/recurrence.

PubMed

Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne

2016-02-01

Clinical decision-making regarding the prevention of depression is complex for pregnant women with histories of depression and their health care providers. Pregnant women with histories of depression report preference for nonpharmacological care, but few evidence-based options exist. Mindfulness-based cognitive therapy has strong evidence in the prevention of depressive relapse/recurrence among general populations and indications of promise as adapted for perinatal depression (MBCT-PD). With a pilot randomized clinical trial, our aim was to evaluate treatment acceptability and efficacy of MBCT-PD relative to treatment as usual (TAU). Pregnant adult women with depression histories were recruited from obstetric clinics at 2 sites and randomized to MBCT-PD (N = 43) or TAU (N = 43). Treatment acceptability was measured by assessing completion of sessions, at-home practice, and satisfaction. Clinical outcomes were interview-based depression relapse/recurrence status and self-reported depressive symptoms through 6 months postpartum. Consistent with predictions, MBCT-PD for at-risk pregnant women was acceptable based on rates of completion of sessions and at-home practice assignments, and satisfaction with services was significantly higher for MBCT-PD than TAU. Moreover, at-risk women randomly assigned to MBCT-PD reported significantly improved depressive outcomes compared with participants receiving TAU, including significantly lower rates of depressive relapse/recurrence and lower depressive symptom severity during the course of the study. MBCT-PD is an acceptable and clinically beneficial program for pregnant women with histories of depression; teaching the skills and practices of mindfulness meditation and cognitive-behavioral therapy during pregnancy may help to reduce the risk of depression during an important transition in many women's lives. (c) 2016 APA, all rights reserved).

Acceptance testing for PACS: from methodology to design to implementation

NASA Astrophysics Data System (ADS)

Liu, Brent J.; Huang, H. K.

2004-04-01

Acceptance Testing (AT) is a crucial step in the implementation process of a PACS within a clinical environment. AT determines whether the PACS is ready for clinical use and marks the official sign off of the PACS product. Most PACS vendors have Acceptance Testing (AT) plans, however, these plans do not provide a complete and robust evaluation of the full system. In addition, different sites will have different special requirements that vendor AT plans do not cover. The purpose of this paper is to introduce a protocol for AT design and present case studies of AT performed on clinical PACS. A methodology is presented that includes identifying testing components within PACS, quality assurance for both functionality and performance, and technical testing focusing on key single points-of-failure within the PACS product. Tools and resources that provide assistance in performing AT are discussed. In addition, implementation of the AT within the clinical environment and the overall implementation timeline of the PACS process are presented. Finally, case studies of actual AT of clinical PACS performed in the healthcare environment will be reviewed. The methodology for designing and implementing a robust AT plan for PACS was documented and has been used in PACS acceptance tests in several sites. This methodology can be applied to any PACS and can be used as a validation for the PACS product being acquired by radiology departments and hospitals. A methodology for AT design and implementation was presented that can be applied to future PACS installations. A robust AT plan for a PACS installation can increase both the utilization and satisfaction of a successful implementation of a PACS product that benefits both vendor and customer.

Effects of Acceptance and Commitment Therapy (ACT) Training on Clinical Psychology Trainee Stress, Therapist Skills and Attributes, and ACT Processes.

PubMed

Pakenham, Kenneth I

2015-01-01

Despite the increasing uptake of Acceptance and Commitment Therapy (ACT) by mental health practitioners, few studies have investigated the effects of ACT training on trainees. Clinical psychology trainees (CPTs) are susceptible to high stress such that their training represents a teachable moment for personal application of the therapy skills they learn for clinical practice. This study investigates the effects of ACT training on stress, therapist skills and attributes, and the personal acquisition of ACT strategies in CPTs. Thirty-two CPTs completed questionnaires before and after university-based ACT training that consisted of 12 2-h weekly workshops. Pairwise t-tests showed that CPTs reported improvements from before to after training on measures of counselling self-efficacy, client-therapist alliance, self-kindness, acceptance, defusion, mindfulness and values, and a marginally significant improvement on somatic symptoms, despite a trend towards increased work-related stress. As predicted, each of the ACT process variables was related to one or more of the therapist stress, skill and attribute variables, such that greater levels of mindfulness, values and acceptance, and less thought suppression were related to better trainee outcomes. This study provides preliminary data on therapist skill development and personal benefits for CPTs related to receiving ACT training that interweaves instruction in competencies acquisition with self-care. This study provides preliminary data on therapist skill development and personal benefits for clinical psychology trainees related to receiving ACT training that integrates training in competencies acquisition with self-care. The ACT training offers a framework for integrating the acquisition of clinical competencies and self-care skills and positive therapist attributes in trainees. Findings support a strong positive union between the ACT processes and better trainee personal and professional outcomes. Copyright © 2014 John Wiley & Sons, Ltd.

Patients' Willingness to Participate in Rapid HIV Testing: A pilot study in three New York City dental hygiene clinics.

PubMed

Davide, Susan H; Santella, Anthony J; Furnari, Winnie; Leuwaisee, Petal; Cortell, Marilyn; Krishnamachari, Bhuma

2017-12-01

Purpose: One in eight people living with an HIV infection in the United States is unaware of their status. Rapid HIV testing (RHT) is an easily used and accepted screening tool that has been introduced in a limited number of clinical settings. The purpose of this study was to investigate patient acceptability, certainty of their decision, and willingness to pay for screening if RHT was offered in university-based dental hygiene clinics. Methods: A cross-sectional survey was administered to 426 patients at three dental hygiene clinics in New York City over a period of four months. The survey questionnaire was based on the decisional conflict scale measuring personal perceptions; with zero indicating extremely high conflict to four indicating no conflict. Patients were assessed for their acceptance of RHT, provider preference for administration of the test and their willingness to pay for RHT. Results: Over half (72.2%) indicated acceptance of HIV testing in a dental hygiene clinic setting; with 85.3% choosing oral RHT, 4.9% fingerstick RHT, and 8.8% venipuncture. Respondents were amenable to testing when offered by dental hygienists (71.7%) and dentists (72.4%). Over 30% indicated their willingness to receive HIV testing in the dental setting when offered at no additional cost. The mean decisional conflict score was 3.42/4.0 indicating no decisional conflict. Conclusions: Patients are willing to undergo oral RHT when offered as a service and provided by dental hygienists in the dental setting. Patients appear to be aware of the benefits and risks associated with RHT. Further research is needed to evaluate the public health benefits and logistical challenges facing the delivery of RHT within in the dental setting. Copyright © 2017 The American Dental Hygienists’ Association.

Development and validation of the brief esophageal dysphagia questionnaire.

PubMed

Taft, T H; Riehl, M; Sodikoff, J B; Kahrilas, P J; Keefer, L; Doerfler, B; Pandolfino, J E

2016-12-01

Esophageal dysphagia is common in gastroenterology practice and has multiple etiologies. A complication for some patients with dysphagia is food impaction. A valid and reliable questionnaire to rapidly evaluate esophageal dysphagia and impaction symptoms can aid the gastroenterologist in gathering information to inform treatment approach and further evaluation, including endoscopy. 1638 patients participated over two study phases. 744 participants completed the Brief Esophageal Dysphagia Questionnaire (BEDQ) for phase 1; 869 completed the BEDQ, Visceral Sensitivity Index, Gastroesophageal Reflux Disease Questionnaire, and Hospital Anxiety and Depression Scale for phase 2. Demographic and clinical data were obtained via the electronic medical record. The BEDQ was evaluated for internal consistency, split-half reliability, ceiling and floor effects, and construct validity. The BEDQ demonstrated excellent internal consistency, reliability, and construct validity. The symptom frequency and severity scales scored above the standard acceptable cutoffs for reliability while the impaction subscale yielded poor internal consistency and split-half reliability; thus the impaction items were deemed qualifiers only and removed from the total score. No significant ceiling or floor effects were found with the exception of 1 item, and inter-item correlations fell within accepted ranges. Construct validity was supported by moderate yet significant correlations with other measures. The predictive ability of the BEDQ was small but significant. The BEDQ represents a rapid, reliable, and valid assessment tool for esophageal dysphagia with food impaction for clinical practice that differentiates between patients with major motor dysfunction and mechanical obstruction. © 2016 John Wiley & Sons Ltd.

Development and Validation of the Brief Esophageal Dysphagia Questionnaire

PubMed Central

Taft, Tiffany H.; Riehl, Megan; Sodikoff, Jamie B.; Kahrilas, Peter J.; Keefer, Laurie; Doerfler, Bethany; Pandolfino, John E.

2017-01-01

Background Esophageal dysphagia is common in gastroenterology practice and has multiple etiologies. A complication for some patients with dysphagia is food impaction. A valid and reliable questionnaire to rapidly evaluate esophageal dysphagia and impaction symptoms can aid the gastroenterologist in gathering information to inform treatment approach and further evaluation, including endoscopy. Methods 1,638 patients participated over two study phases. 744 participants completed the Brief Esophageal Dysphagia Questionnaire (BEDQ) for phase 1; 869 completed the BEDQ, Visceral Sensitivity Index, Gastroesophageal Reflux Disease Questionnaire, and Hospital Anxiety and Depression Scale for phase 2. Demographic and clinical data were obtained via the electronic medical record. The BEDQ was evaluated for internal consistency, split-half reliability, ceiling and floor effects, and construct validity. Key Results The BEDQ demonstrated excellent internal consistency, reliability, and construct validity. The symptom frequency and severity scales scored above the standard acceptable cutoffs for reliability while the impaction subscale yielded poor internal consistency and split-half reliability; thus the impaction items were deemed qualifiers only and removed from the total score. No significant ceiling or floor effects were found with the exception of 1 item, and inter-item correlations fell within accepted ranges. Construct validity was supported by moderate yet significant correlations with other measures. The predictive ability of the BEDQ was small but significant. Conclusions & Inferences The BEDQ represents a rapid, reliable and valid assessment tool for esophageal dysphagia with food impaction for clinical practice that differentiates between patients with major motor dysfunction and mechanical obstruction. PMID:27380834

Immigrant general practitioners in Norway: a special resource? A qualitative study.

PubMed

Díaz, Esperanza; Hjörleifsson, Stefán

2011-05-01

To explore whether and how immigrant general practitioners (GPs) in two major cities in Norway think that their own ethnic background affects their practices and their work. Qualitative focus group and individual interviews with seven immigrant GPs, five men and two women, age 36-65 years. Their clinical experience in Norwegian primary health care ranged from four to 30 years. Analysis was conducted by systematic text condensation. First, immigrant GPs described a gradual process of becoming bicultural: the GPs communicate with immigrant patients on their own terms and draw upon their special knowledge from abroad to help selected patients, while also adapting to Norwegian cultural expectations of the GP's role. Second, the GPs described being aware of cultural issues in consultations with immigrant and Norwegian patients, but rarely making these issues explicit. The GPs ventured that cultural awareness, together with their personal experience in their own countries and as immigrants in Norway, made them able to sometimes help immigrant patients better than Norwegian GPs. Third, immigrant GPs experienced a big workload related to immigrant patients, but they accepted this as a natural part of their work. Fourth, immigrant GPs felt that they had to work harder and be more careful than their Norwegian colleagues in order to avoid complaints from patients, and to be accepted by colleagues. Immigrant GPs express broad cultural competence and keen cultural awareness in their consultations. The immigrant background of these GPs could be considered as a special resource for clinical practice.

A review of human factors principles for the design and implementation of medication safety alerts in clinical information systems.

PubMed

Phansalkar, Shobha; Edworthy, Judy; Hellier, Elizabeth; Seger, Diane L; Schedlbauer, Angela; Avery, Anthony J; Bates, David W

2010-01-01

The objective of this review is to describe the implementation of human factors principles for the design of alerts in clinical information systems. First, we conduct a review of alarm systems to identify human factors principles that are employed in the design and implementation of alerts. Second, we review the medical informatics literature to provide examples of the implementation of human factors principles in current clinical information systems using alerts to provide medication decision support. Last, we suggest actionable recommendations for delivering effective clinical decision support using alerts. A review of studies from the medical informatics literature suggests that many basic human factors principles are not followed, possibly contributing to the lack of acceptance of alerts in clinical information systems. We evaluate the limitations of current alerting philosophies and provide recommendations for improving acceptance of alerts by incorporating human factors principles in their design.

Clinical research involving minors in international and serbian regulations.

PubMed

Planojević, Nina; Zivojinović, Dragica

2013-07-01

Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

Cognitive and Emotion Regulation Change Processes in Cognitive Behavioural Therapy for Social Anxiety Disorder.

PubMed

O'Toole, Mia S; Mennin, Douglas S; Hougaard, Esben; Zachariae, Robert; Rosenberg, Nicole K

2015-01-01

The objective of the study was to investigate variables, derived from both cognitive and emotion regulation conceptualizations of social anxiety disorder (SAD), as possible change processes in cognitive behaviour therapy (CBT) for SAD. Several proposed change processes were investigated: estimated probability, estimated cost, safety behaviours, acceptance of emotions, cognitive reappraisal and expressive suppression. Participants were 50 patients with SAD, receiving a standard manualized CBT program, conducted in groups or individually. All variables were measured pre-therapy, mid-therapy and post-therapy. Lower level mediation models revealed that while a change in most process measures significantly predicted clinical improvement, only changes in estimated probability and cost and acceptance of emotions showed significant indirect effects of CBT for SAD. The results are in accordance with previous studies supporting the mediating role of changes in cognitive distortions in CBT for SAD. In addition, acceptance of emotions may also be a critical component to clinical improvement in SAD during CBT, although more research is needed on which elements of acceptance are most helpful for individuals with SAD. The study's lack of a control condition limits any conclusion regarding the specificity of the findings to CBT. Change in estimated probability and cost, and acceptance of emotions showed an indirect effect of CBT for SAD. Cognitive distortions appear relevant to target with cognitive restructuring techniques. Finding acceptance to have an indirect effect could be interpreted as support for contemporary CBT approaches that include acceptance-based strategies. Copyright © 2014 John Wiley & Sons, Ltd.

Searching the optimal PTH target range in children undergoing peritoneal dialysis: new insights from international cohort studies.

PubMed

Haffner, Dieter; Schaefer, Franz

2013-04-01

The treatment of the mineral and bone disorder associated with chronic kidney disease (CKD-MBD) remains a major challenge in pediatric patients. The principal aims of therapeutic measures are not only to prevent the debilitating skeletal complications and to achieve normal growth but also to preserve long-term cardiovascular health. Serum parathyroid hormone (PTH) levels are used as a surrogate parameter of bone turnover. Whereas it is generally accepted that serum calcium and phosphate levels should be kept within the range for age, current pediatric consensus guidelines differ markedly with respect to the optimal PTH target range and operate on a limited evidence base. Recently, the International Pediatric Dialysis Network (IPPN) established a global registry collecting detailed clinical and biochemical information, including data relevant to CKD-MBD in children on chronic peritoneal dialysis (PD). This review highlights the current evidence basis regarding the optimal PTH target range in pediatric CKD patients, and re-assesses the current guidelines in view of the outcome data collected by the IPPN registry. Based on a comprehensive evaluation of CKD-MBD outcome measures in this global patient cohort, a PTH target range of 1.7-3 times the upper limit of normal (i.e. 100-200 pg/ml) appears reasonable in children undergoing chronic PD.

Pairing motivational interviewing with a nutrition and physical activity assessment and counseling tool in pediatric clinical practice: a pilot study.

PubMed

Christison, Amy L; Daley, Brendan M; Asche, Carl V; Ren, Jinma; Aldag, Jean C; Ariza, Adolfo J; Lowry, Kelly W

2014-10-01

Recommendations to screen and counsel for lifestyle behaviors can be challenging to implement during well-child visits in the primary care setting. A practice intervention was piloted using the Family Nutrition and Physical Activity (FNPA) Screening Tool paired with a motivational interviewing (MI)-based counseling tool during well-child visits. Acceptability and feasibility of this intervention were assessed. Its impact on parent-reported obesigenic behavior change and provider efficacy in lifestyle counseling were also examined. This was an observational study in a pediatric primary care office. During well-child visits of 100 patients (ages 4-16 years), the FNPA tool was implemented and providers counseled patients in an MI-consistent manner based on its results. Duration of implementation, patient satisfaction of the intervention, and success of stated lifestyle goals were measured. Provider self-efficacy and acceptability were also surveyed. The FNPA assessment was efficient to administer, requiring minutes to complete and score. Patient acceptability was high, ranging from 4.0 to 4.8 on a 5-point scale. Provider acceptability was good, with the exception of duration of counseling; self-efficacy in assessing patient "readiness for change" was improved. Parent-reported success of primary lifestyle goal was 68% at 1 month and 46% at 6 months. The FNPA assessment with an MI-based counseling tool shows promise as an approach to identify and address obesigenic behaviors during pediatric well-child visits. It has the potential to improve provider efficacy in obesity prevention and also influence patient health behaviors, which can possibly impact childhood excessive weight gain. After refinement, this practice intervention will be used in a larger trial.

Examining the Acceptability of mHealth Technology in HIV Prevention Among High-Risk Drug Users in Treatment.

PubMed

Shrestha, Roman; Huedo-Medina, Tania B; Altice, Frederick L; Krishnan, Archana; Copenhaver, Michael

2017-11-01

Despite promising trends of the efficacy of mobile health (mHealth) based strategies to a broad range of health conditions, very few if any studies have been done in terms of the examining the use of mHealth in HIV prevention efforts among people who use drugs in treatment. Thus, the goal of this study was to gain insight into the real-world acceptance of mHealth approaches among high-risk people who use drugs in treatment. A convenience sample of 400 HIV-negative drug users, who reported drug- and/or sex-related risk behaviors, were recruited from a methadone clinic in New Haven, Connecticut. Participants completed standardized assessments of drug- and sex-related risk behaviors, neurocognitive impairment (NCI), and measures of communication technology access and utilization, and mHealth acceptance. We found a high prevalence of current ownership and use of mobile technologies, such as cell phone (91.5%) including smartphone (63.5%). Participants used mobile technologies to communicate mostly through phone calls (M = 4.25, SD = 1.24), followed by text messages (M = 4.21, SD = 1.29). Participants expressed interest in using mHealth for medication reminders (72.3%), receive information about HIV (65.8%), and to assess drug-related (72.3%) and sex-related behaviors (64.8%). Furthermore, participants who were neurocognitively impaired were more likely to use cell phone without internet and show considerable interest in using mHealth as compared to those without NCI. The findings from this study provide empirical evidence that mHealth-based programs, specifically cell phone text messaging-based health programs, may be acceptable to this high-risk population.

Medical abortion with mifepristone and home administration of misoprostol up to 63 days' gestation.

PubMed

Løkeland, Mette; Iversen, Ole Erik; Engeland, Anders; Økland, Ingrid; Bjørge, Line

2014-07-01

To evaluate the acceptability and efficacy of medical abortion at home up to 63 days' gestation without limits on travel distance to a registered institution. Observational prospective study. Haukeland University Hospital between May 2006 and May 2009. A total of 1018 women requesting abortion before 63 days' gestation who chose medical termination with mifepristone and home administration of misoprostol. The women took 200 mg mifepristone under nurse supervision and self-administered 800 μg misoprostol vaginally 36-48 h later at home. All were contacted by phone for follow-up and assessment of bleeding, pain and acceptability. Evacuation rate, pain, bleeding, acceptability, influence of distance on treatment. Median gestational age was 50 (range 35-63) days and 70 (7.1%) of the women lived more than 60 min travel from the clinic. The rate of completed abortion was 93.6% and surgical evacuation was performed in 50 (4.9%) cases. Two women requested treatment on the day of misoprostol use. Moderate to strong pain was experienced by 68.4%, and 74.7% reported moderate to heavy bleeding. Parous women experienced less pain than nulliparous women (odds ratio 0.27; 95% confidence interval 0.19-0.34). In all, 95.1% of the women were satisfied with staying at home. Travel distance did not influence treatment outcome variables. In our experience, home administration of misoprostol is an effective and acceptable method for abortion up to 63 days of gestation and women should be eligible for this treatment option regardless of their travel distance from hospital. © 2014 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons on behalf of Nordic Federation of Societies of Obstetrics and Gynecology.

Electronic Brief Intervention and Text Messaging for Marijuana Use During Pregnancy: Initial Acceptability of Patients and Providers

PubMed Central

Gray, Justin; Svikis, Dace S; Puder, Karoline S; Resnicow, Ken; Konkel, Janine; Rice, Shetoya; McGoron, Lucy; Ondersma, Steven J

2017-01-01

Background Marijuana is the most widely used illicit substance during pregnancy. Technology-delivered brief interventions and text messaging have shown promise in general and pregnant samples but have not yet been applied to marijuana use in pregnancy. Objective The objective of the study was to evaluate, among pregnant women and prenatal care providers, the acceptability of an electronic brief intervention and text messaging plan for marijuana use in pregnancy. Methods Participants included patients (n=10) and medical staff (n=12) from an urban prenatal clinic. Patient-participants were recruited directly during a prenatal care visit. Those who were eligible reviewed the interventions individually and provided quantitative and qualitative feedback regarding software acceptability and helpfulness during a one-on-one interview with research staff. Provider-participants took part in focus groups in which the intervention materials were reviewed and discussed. Qualitative and focus group feedback was transcribed, coded manually, and classified by category and theme. Results Patient-participants provided high ratings for satisfaction, with mean ratings for respectfulness, interest, ease of use, and helpfulness ranging between 4.4 and 4.7 on a 5-point Likert scale. Of the 10 participants, 5 reported that they preferred working with the program versus their doctor, and 9 of 10 said the intervention made them more likely to reduce their marijuana use. Provider-participants received the program favorably, stating the information presented was both relevant and important for their patient population. Conclusions The findings support the acceptability of electronic brief intervention and text messaging for marijuana use during pregnancy. This, combined with their ease of use and low barrier to initiation, suggests that further evaluation in a randomized trial is appropriate. PMID:29117931

Clinical Evaluation of a Prototype Underwear Designed to Detect Urine Leakage From Continence Pads.

PubMed

Long, Adele; Edwards, Julia; Worthington, Joanna; Cotterill, Nikki; Weir, Iain; Drake, Marcus J; van den Heuvel, Eleanor

2015-01-01

We evaluated the performance of prototype underwear designed to detect urine leakage from continence pads, their acceptability to users, and their effect on health-related quality of life and psychosocial factors. Prototype product evaluation. Participants were 81 women with an average age of 67 years (range, 32-98 years) recruited between October 2010 and February 2012 from outpatient clinics, general practice surgeries, community continence services, and through charities and networks. The TACT3 project developed and manufactured a prototype undergarment designed to alert the wearer to a pad leak before it reaches outer clothing or furniture. The study was conducted in 2 stages: a pilot/feasibility study to assess general performance and a larger study to measure performance, acceptability to users, health-related quality of life, and psychosocial impact. Participants were asked to wear the prototype underwear for a period of 2 weeks, keeping a daily diary of leakage events for the first 7 days. They also completed validated instruments measuring lower urinary tract symptoms, health-related quality of life, and psychosocial impact. On average, 86% of the time participants were alerted to pad leakage events. More than 90% thought the prototype underwear was "good" or "OK" and that it would or could give them more confidence. Mean scores for the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form indicated no change in the level of symptoms reported before or after the intervention, and no significant changes in health-related quality of life status occurred, except improvement in for travel restrictions. Evaluation via the Psychosocial Impact of Assistive Devices Scale also indicated a positive impact. The prototype underwear evaluated in this study was effective and acceptable for 5 out of every 10 wearers. Findings also suggest that the prototype underwear is suitable for women of all ages, dress sizes, and continence severity.

Living with chronic illness scale: international validation of a new self-report measure in Parkinson’s disease

PubMed Central

Ambrosio, Leire; Portillo, Mari Carmen; Rodríguez-Blázquez, Carmen; Rodriguez-Violante, Mayela; Castrillo, Juan Carlos Martínez; Arillo, Víctor Campos; Garretto, Nélida Susana; Arakaki, Tomoko; Dueñas, Marcos Serrano; Álvarez, Mario; Ibáñez, Ivonne Pedroso; Carvajal, Ana; Martínez-Martín, Pablo

2016-01-01

Understanding how a person lives with a chronic illness, such as Parkinson’s disease (PD), is necessary to provide individualized care and professionals role in person-centered care at clinical and community levels is paramount. The present study was aimed to analyze the psychometric properties of the Living with Chronic Illness-PD Scale (EC-PC) in a wide Spanish-speaking population with PD. International cross-sectional study with retest was carried out with 324 patients from four Latin American countries and Spain. Feasibility, acceptability, scaling assumptions, reliability, precision, and construct validity were tested. The study included 324 patients, with age (mean±s.d.) 66.67±10.68 years. None of the EC-PC items had missing values and all acceptability parameters fulfilled the standard criteria. Around two-third of the items (61.54%) met scaling assumptions standards. Concerning internal consistency, Cronbach’s alpha values were 0.68–0.88; item-total correlation was >0.30, except for two items; item homogeneity index was >0.30, and inter-item correlation values 0.14–0.76. Intraclass correlation coefficient for EC-PC stability was 0.76 and standard error of measurement (s.e.m.) for precision was 8.60 (for a EC-PC s.d.=18.57). EC-PC presented strong correlation with social support (rS=0.61) and moderate correlation with life satisfaction (rS=0.46). Weak and negligible correlations were found with the other scales. Internal validity correlations ranged from 0.46 to 0.78. EC-PC total scores were significantly different for each severity level based on Hoehn and Yahr and Clinical Impression of Severity Index, but not for Patient Global Impression of Severity. The EC-PC has satisfactory acceptability, reliability, precision, and validity to evaluate living with PD. PMID:28725703

EAU standardised medical terminology for urologic imaging: a taxonomic approach.

PubMed

Loch, Tillmann; Carey, Brendan; Walz, Jochen; Fulgham, Pat Fox

2015-05-01

The terminology and abbreviations used in urologic imaging have generally been adopted on an ad hoc basis by different speciality groups; however, there is a need for shared nomenclature to facilitate clinical communication and collaborative research. This work reviews the current nomenclature for urologic imaging used in clinical practice and proposes a taxonomy and terminology for urologic imaging studies. A list of terms used in urologic imaging were compiled from guidelines published by the European Association of Urology and the American Urological Association and from the American College of Radiology Appropriateness Criteria. Terms searched were grouped into broad categories based on technology, and imaging terms were further stratified based on the anatomic extent, contrast or phases, technique or modifiers, and combinations or fusions. Terms that had a high degree of utilisation were classified as accepted. We propose a new taxonomy to define a more useful and acceptable nomenclature model acceptable to all health professionals involved in urology. The major advantage of a taxonomic approach to the classification of urologic imaging studies is that it provides a flexible framework for classifying the modifications of current imaging modalities and allows the incorporation of new imaging modalities. The adoption of this hierarchical classification model ranging from the most general to the most detailed descriptions should facilitate hierarchical searches of the medical literature using both general and specific terms. This work is limited in its scope, as it is not currently all-inclusive. This will hopefully be addressed by future modification as others embrace the concept and work towards uniformity in nomenclature. This paper provides a noncomprehensive list of the most widely used terms across different specialties. This list can be used as the basis for further discussion, development, and enhancement. In this paper we describe a classification system for urologic imaging terms with the aim of aiding health professionals and ensuring that the terms used are more consistent. Copyright © 2014 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Long-term follow-up after latissimus dorsi transfer for irreparable posterosuperior rotator cuff tears.

PubMed

El-Azab, Hossam Mahmoud; Rott, Olaf; Irlenbusch, Ulrich

2015-03-18

Irreparable posterosuperior rotator cuff tears are treated in several ways. Transfer of the latissimus dorsi is an alternative with acceptable mid-term results, but long-term results have rarely been published. The cases of 108 consecutive patients with 115 shoulders treated with latissimus dorsi transfer between 2000 and 2005 were reviewed clinically and radiographically. Ninety-three shoulders in eighty-six patients were included in the follow-up analysis. The mean duration of follow-up was 9.3 years (range, 6.6 to 11.7 years), and the mean age at the operation was fifty-six years (range, forty to seventy-two years). Outcome measures included the Constant-Murley score (Constant score), American Shoulder and Elbow Surgeons (ASES) index, and visual analog scale (VAS) for pain. The progress of cuff tear arthropathy was determined with radiographic evaluation according to the system described by Hamada et al. The mean relative Constant score improved from 44% preoperatively to 71% at the time of follow-up (p < 0.0001, effect size = 0.6), excluding the clinical failures. Similarly, the mean ASES index improved from 30 to 70 (p < 0.0001, effect size = 0.7), and the mean VAS score decreased from 7.8 to 2.4 (p < 0.0001, effect size = 0.8). A pain-free outcome was reported in only eighteen shoulders (19%). Active shoulder movement improved significantly (p < 0.05). The mean Hamada radiographic grade of cuff tear arthropathy increased from 1.7 (range, 0 to 2) preoperatively to 2.2 (range, 1 to 5) (p < 0.0001, effect size = 0.2). The rate of clinical failure of latissimus dorsi transfer was 10%, and the rate of shoulder prosthetic replacement after latissimus dorsi transfer was 4%. Pain relief and improvement of shoulder function were maintained a mean of 9.3 years after latissimus dorsi transfer for irreparable posterosuperior cuff defects. The younger the patient, the better the outcome. Copyright © 2015 by The Journal of Bone and Joint Surgery, Incorporated.

Canadian Cytogenetic Emergency network (CEN) for biological dosimetry following radiological/nuclear accidents.

PubMed

Miller, Susan M; Ferrarotto, Catherine L; Vlahovich, Slavica; Wilkins, Ruth C; Boreham, Douglas R; Dolling, Jo-Anna

2007-07-01

To test the ability of the cytogenetic emergency network (CEN) of laboratories, currently under development across Canada, to provide rapid biological dosimetry using the dicentric assay for triage assessment, that could be implemented in the event of a large-scale radiation/nuclear emergency. A workshop was held in May 2004 in Toronto, Canada, to introduce the concept of CEN and recruit clinical cytogenetic laboratories at hospitals across the country. Slides were prepared for dicentric assay analysis following in vitro irradiation of blood to a range of gamma-ray doses. A minimum of 50 metaphases per slide were analyzed by 41 people at 22 different laboratories to estimate the exposure level. Dose estimates were calculated based on a dose response curve generated at Health Canada. There were a total of 104 dose estimates and 96 (92.3%) of them fell within the expected range using triage scoring criteria. Half of the laboratories analyzed 50 metaphases in

Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review.

PubMed

Berry, Natalie; Lobban, Fiona; Emsley, Richard; Bucci, Sandra

2016-05-31

Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed.

Acceptability of Interventions Delivered Online and Through Mobile Phones for People Who Experience Severe Mental Health Problems: A Systematic Review

PubMed Central

Lobban, Fiona; Emsley, Richard; Bucci, Sandra

2016-01-01

Background Psychological interventions are recommended for people with severe mental health problems (SMI). However, barriers exist in the provision of these services and access is limited. Therefore, researchers are beginning to develop and deliver interventions online and via mobile phones. Previous research has indicated that interventions delivered in this format are acceptable for people with SMI. However, a comprehensive systematic review is needed to investigate the acceptability of online and mobile phone-delivered interventions for SMI in depth. Objective This systematic review aimed to 1) identify the hypothetical acceptability (acceptability prior to or without the delivery of an intervention) and actual acceptability (acceptability where an intervention was delivered) of online and mobile phone-delivered interventions for SMI, 2) investigate the impact of factors such as demographic and clinical characteristics on acceptability, and 3) identify common participant views in qualitative studies that pinpoint factors influencing acceptability. Methods We conducted a systematic search of the databases PubMed, Embase, PsycINFO, CINAHL, and Web of Science in April 2015, which yielded a total of 8017 search results, with 49 studies meeting the full inclusion criteria. Studies were included if they measured acceptability through participant views, module completion rates, or intervention use. Studies delivering interventions were included if the delivery method was online or via mobile phones. Results The hypothetical acceptability of online and mobile phone-delivered interventions for SMI was relatively low, while actual acceptability tended to be high. Hypothetical acceptability was higher for interventions delivered via text messages than by emails. The majority of studies that assessed the impact of demographic characteristics on acceptability reported no significant relationships between the two. Additionally, actual acceptability was higher when participants were provided remote online support. Common qualitative factors relating to acceptability were safety and privacy concerns, the importance of an engaging and appealing delivery format, the inclusion of peer support, computer and mobile phone literacy, technical issues, and concerns about the impact of psychological state on intervention use. Conclusions This systematic review provides an in-depth focus on the acceptability of online and mobile phone-delivered interventions for SMI and identified the need for further research in this area. Based on the results from this review, we recommend that researchers measure both hypothetical and actual acceptability to identify whether initial perceptions of online and mobile phone-delivered interventions change after access. In addition, more focus is needed on the potential impact of demographic and clinical characteristics on acceptability. The review also identified issues with module completion rates and intervention use as measures of acceptability. We therefore advise researchers to obtain qualitative reports of acceptability throughout each phase of intervention development and testing. Further implications and opportunities for future research are discussed. PMID:27245693

A systematic review of publications on charged particle therapy for hepatocellular carcinoma.

PubMed

Igaki, Hiroshi; Mizumoto, Masashi; Okumura, Toshiyuki; Hasegawa, Kiyoshi; Kokudo, Norihiro; Sakurai, Hideyuki

2018-06-01

Charged particle therapy (proton beam therapy and carbon ion therapy) is a form of radiotherapy which has the unique characteristic of superior depth dose distribution, and has been used for the treatment of hepatocellular carcinoma (HCC) in a limited number of patients, especially in Japan. We undertook a systematic review to define the clinical utility of charged particle therapy for patients with HCC. We searched the MEDLINE database from 1983 to June 2016 to identify clinical studies on charged particle therapy for HCC. Primary outcomes of interest were local control, overall survival, and late radiation morbidities. A total of 13 cohorts from 11 papers were selected from an initial dataset of 78 papers. They included a randomized controlled trial comparing proton beam therapy with transarterial chemoembolization, 9 phase I or II trials and 2 retrospective studies. The reported actuarial local control rates ranged from 71.4-95% at 3 years, and the overall survival rates ranged from 25-42.3% at 5 years. Late severe radiation morbidities were uncommon, and a total of 18 patients with grade ≥3 late adverse events were reported among the 787 patients included in this analysis. Charged particle therapy for HCC was associated with good local control with limited probability of severe morbidities. The cost-effectiveness and the distinctive clinical advantages of charged particle therapies should be clarified in order to become a socially accepted treatment modality for HCC.

Rapid evaluation of fibrinogen levels using the CG02N whole blood coagulation analyzer.

PubMed

Hayakawa, Mineji; Gando, Satoshi; Ono, Yuichi; Mizugaki, Asumi; Katabami, Kenichi; Maekawa, Kunihiko; Miyamoto, Daisuke; Wada, Takeshi; Yanagida, Yuichiro; Sawamura, Atsushi

2015-04-01

Rapid evaluation of fibrinogen (Fbg) levels is essential for maintaining homeostasis in patients with massive bleeding during severe trauma and major surgery. This study evaluated the accuracy of fibrinogen levels measured by the CG02N whole blood coagulation analyzer (A&T Corporation, Kanagawa, Japan) using heparinized blood drawn for blood gas analysis (whole blood-Fbg). A total of 100 matched pairs of heparinized blood samples and citrated blood samples were simultaneously collected from patients in the intensive care unit. Whole blood-Fbg results were compared with those of citrated plasma (standard-Fbg). The whole blood coagulation analyzer measured fibrinogen levels within 2 minutes. Strong correlations between standard-Fbg and whole blood-Fbg were observed (ρ = 0.91, p < 0.001). Error grid analysis showed that 88% of the values were clinically acceptable, and 12% were in a range with possible effects on clinical decision-making; none were in a clinically dangerous range without appropriate treatment. Using a fibrinogen cutoff value of 1.5 g/L for standard-Fbg, the area under the receiver operating characteristic curve of whole blood-Fbg was 0.980 (95% confidence interval 0.951-1.000, p < 0.001). The whole blood coagulation analyzer can rapidly measure fibrinogen levels in heparinized blood and could be useful in critical care settings where excessive bleeding is a concern. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

Reliability and group differences in quantitative cervicothoracic measures among individuals with and without chronic neck pain

PubMed Central

2012-01-01

Background Clinicians frequently rely on subjective categorization of impairments in mobility, strength, and endurance for clinical decision-making; however, these assessments are often unreliable and lack sensitivity to change. The objective of this study was to determine the inter-rater reliability, minimum detectable change (MDC), and group differences in quantitative cervicothoracic measures for individuals with and without chronic neck pain (NP). Methods Nineteen individuals with NP and 20 healthy controls participated in this case control study. Two physical therapists performed a 30-minute examination on separate days. A handheld dynamometer, gravity inclinometer, ruler, and stopwatch were used to quantify cervical range of motion (ROM), cervical muscle strength and endurance, and scapulothoracic muscle length and strength, respectively. Results Intraclass correlation coefficients for inter-rater reliability were significantly greater than zero for most impairment measures, with point estimates ranging from 0.45 to 0.93. The NP group exhibited reduced cervical ROM (P ≤ 0.012) and muscle strength (P ≤ 0.038) in most movement directions, reduced cervical extensor endurance (P = 0.029), and reduced rhomboid and middle trapezius muscle strength (P ≤ 0.049). Conclusions Results demonstrate the feasibility of obtaining objective cervicothoracic impairment measures with acceptable inter-rater agreement across time. The clinical utility of these measures is supported by evidence of impaired mobility, strength, and endurance among patients with NP, with corresponding MDC values that can help establish benchmarks for clinically significant change. PMID:23114092

An open trial of mindfulness-based stress reduction for young adults with social anxiety disorder.

PubMed

Hjeltnes, Aslak; Molde, Helge; Schanche, Elisabeth; Vøllestad, Jon; Lillebostad Svendsen, Julie; Moltu, Christian; Binder, Per-Einar

2017-02-01

The present study investigated mindfulness-based stress reduction (MBSR) for young adults with a social anxiety disorder (SAD) in an open trial. Fifty-three young adults in a higher education setting underwent a standard eight-week MBSR program. Eight participants (15%) did not complete the program. Participants reported significant reductions in SAD symptoms and global psychological distress, as well as increases in mindfulness, self-compassion, and self-esteem. Using intention-to-treat (ITT) analyses, effect sizes ranged from large to moderate for SAD symptoms (Cohen's d = 0.80) and global psychological distress (d = 0.61). Completer analyses yielded large effect sizes for SAD symptoms (d = 0.96) and global psychological distress (d = 0.81). The largest effect sizes were found for self-compassion (d = 1.49) and mindfulness (d = 1.35). Two thirds of the participants who were in the clinical range at pretreatment reported either clinically significant change (37%) or reliable improvement (31%) on SAD symptoms after completing the MBSR program, and almost two thirds reported either clinically significant change (37%) or reliable improvement (26%) on global psychological distress. MBSR may be a beneficial intervention for young adults in higher education with SAD, and there is a need for more research on mindfulness and acceptance-based interventions for SAD. © 2016 Scandinavian Psychological Associations and John Wiley & Sons Ltd.

Telemedicine and other care models in pediatric rheumatology: an exploratory study of parents' perceptions of barriers to care and care preferences.

PubMed

Bullock, Danielle R; Vehe, Richard K; Zhang, Lei; Correll, Colleen K

2017-07-11

The United States pediatric rheumatology workforce is committed to a mission of providing children access to pediatric rheumatology care. With a limited number and distribution of pediatric rheumatologists, telemedicine has been proposed as one way to meet this mission, yet the adoption of this modality has been slower than expected. The purpose of this study was to explore the parent perspective on barriers to accessing pediatric rheumatology care and to explore the acceptability of telemedicine and other alternative care models. Over a period of six weeks, all new and return English-speaking parents/guardians of patients visiting a single center were offered an opportunity to complete a survey which assessed barriers to care and interest in alternative models of care. Responses were analyzed using descriptive statistics. Survey response rate was 72% (159/221). Twenty-eight percent (45/159) traveled more than three hours to the pediatric rheumatology clinic, and 43% (65/152) reported travel as inconvenient. An overwhelming majority of respondents (95%, 144/152) reported a preference for in-person visits over the option of telemedicine. This preference was similar regardless of whether respondents reported travel to the clinic as inconvenient vs convenient (inconvenient 92%, 60/65; convenient 97%, 84/87; p = 0.2881) and despite those reporting travel as inconvenient also reporting greater difficulty with several barriers to care. Those familiar with telemedicine were more likely to report a preference for telemedicine over in-person visits (27%, 3/11 vs 3%, 4/140; p = 0.0087). The option of an outreach clinic was acceptable to a majority (63%, 97/154); however, adult rheumatology and shared-care options were less acceptable (22%, 35/156 and 34%, 53/156 respectively). Among survey respondents, in-person visits were preferred over the option of telemedicine, even when travel was noted to be inconvenient. Telemedicine familiarity increased its acceptability. Outreach clinics were acceptable to a majority. Ultimately, the parent perspective can shape acceptable ways to address barriers and provide accessible care.

The Child and Adolescent Psychiatry Trials Network

ERIC Educational Resources Information Center

March, John S.; Silva, Susan G.; Compton, Scott; Anthony, Ginger; DeVeaugh-Geiss, Joseph; Califf, Robert; Krishnan, Ranga

2004-01-01

Objective: The current generation of clinical trials in pediatric psychiatry often fails to maximize clinical utility for practicing clinicians, thereby diluting its impact. Method: To attain maximum clinical relevance and acceptability, the Child and Adolescent Psychiatry Trials Network (CAPTN) will transport to pediatric psychiatry the practical…

Anxiety in Children: Recent Advances in Prevention.

ERIC Educational Resources Information Center

Johnson, Suzanne Bennett

As behavioral approaches for the treatment of clinically significant fears became more accepted, the same techniques began to be applied to normal youngsters' reactions to highly stressful situations in an attempt to prevent the development of excessive fears in children. Although there is widespread acceptance of preventative approaches to help…

Evaluating Acceptance and Commitment Therapy: An Analysis of a Recent Critique

ERIC Educational Resources Information Center

Gaudiano, Brandon A.

2011-01-01

Acceptance and commitment therapy (ACT) is a newer psychotherapy that has generated much clinical and research interest in recent years. However, the approach has begun to receive strong criticism from proponents of traditional cognitive-behavioral therapy (CBT). Hofmann and Asmundson (2008) recently compared and contrasted ACT and traditional…

Evaluating Acceptance and Commitment Therapy: An Analysis of a Recent Critique

ERIC Educational Resources Information Center

Gaudiano, Brandon A.

2009-01-01

Acceptance and commitment therapy (ACT) is a newer psychotherapy that has generated much clinical and research interest in recent years. However, the approach has begun to receive strong criticism from proponents of traditional cognitive-behavioral therapy (CBT). Hofmann and Asmundson (2008) recently compared and contrasted ACT and traditional…

Long-term Outcomes Following Artificial Urinary Sphincter Placement: An Analysis of 1082 Cases at Mayo Clinic.

PubMed

Linder, Brian J; Rivera, Marcelino E; Ziegelmann, Matthew J; Elliott, Daniel S

2015-09-01

To evaluate long-term device outcomes following primary artificial urinary sphincter (AUS) implantation. We identified 1802 male patients with stress urinary incontinence that underwent AUS placement from 1983 to 2011. Of these, 1082 (60%) were involving primary implantations and comprise the study cohort. Multiple clinical and surgical variables were evaluated for potential association with treatment failure, defined as any secondary surgery. Patient follow-up was obtained through office examination, operative report, and written or telephone correspondence. Patients undergoing AUS implantation had a median age of 71 years (interquartile range 66-76) and median follow-up of 4.1 years (interquartile range 0.8-7.7). Overall, 338 of 1082 patients (31.2%) underwent secondary surgery, including 89 for device infection and/or erosion, 131 for device malfunction, 89 for urethral atrophy, and 29 for pump malposition or tubing complications. No patient-related risk factors were independently associated with an increased risk of secondary surgery on multivariable analysis. Secondary surgery-free survival was 90% at 1 year, 74% at 5 years, 57% at 10 years, and 41% at 15 years. Primary AUS implantation is associated with acceptable long-term outcomes. Recognition of long-term success is important for preoperative patient counseling. Copyright © 2015 Elsevier Inc. All rights reserved.

Comparison of clinical and functional outcome between surgical treatment and carbon ion radiotherapy for pelvic chondrosarcoma.

PubMed

Outani, Hidetatsu; Hamada, Kenichiro; Imura, Yoshinori; Oshima, Kazuya; Sotobori, Tsukasa; Demizu, Yusuke; Kakunaga, Shigeki; Joyama, Susumu; Imai, Reiko; Okimoto, Tomoaki; Naka, Norifumi; Kudawara, Ikuo; Ueda, Takafumi; Araki, Nobuhito; Kamada, Tadashi; Yoshikawa, Hideki

2016-02-01

As there are no reports of studies in patients with pelvic chondrosarcoma treated with carbon ion radiotherapy (CIRT), the aim of this study was to evaluate the applicability of CIRT for patients with chondrosarcoma of the pelvis. The medical records of 31 patients with chondrosarcoma of the pelvis treated either by surgical resection or by CIRT between 1983 and 2014 were reviewed. There were 22 males and 9 females with a median age of 43 years (range 16-77 years). The median duration of follow-up was 66 months (range 5-289 months). Twenty-four patients underwent surgery, and 7 patients received CIRT (70.4 GyE in 16 fractions over 4 weeks). The overall local recurrence rate was 32 %, and the estimated overall 5- and 10-year survival rates were 72 and 57 %, respectively. The mean Musculoskeletal Tumor Society functional score was 59 %. The treatment procedures (surgery or CIRT) did not affect overall survival (P = 0.347). However, the patients who underwent surgery had impaired function compared with those who received CIRT (P = 0.03). Although more patients need to be monitored to assess the clinical and functional outcomes of CIRT for patients with chondrosarcoma of the pelvis, this treatment might offer an acceptable alternative.

Factor structure and reliability of the childhood trauma questionnaire and prevalence estimates of trauma for male and female street youth.

PubMed

Forde, David R; Baron, Stephen W; Scher, Christine D; Stein, Murray B

2012-01-01

This study examines the psychometric properties of the Childhood Trauma Questionnaire short form (CTQ-SF) with street youth who have run away or been expelled from their homes (N = 397). Internal reliability coefficients for the five clinical scales ranged from .65 to .95. Confirmatory Factor Analysis (CFA) was used to test the five-factor structure of the scales yielding acceptable fit for the total sample. Additional multigroup analyses were performed to consider items by gender. Results provided only evidence of weak factorial invariance. Constrained models showed invariance in configuration, factor loadings, and factor covariances but failed for equality of intercepts. Mean trauma scores for street youth tended to fall in the moderate to severe range on all abuse/neglect clinical scales. Females reported higher levels of abuse and neglect. Prevalence of child maltreatment of individual forms was very high with 98% of street youth reporting one or more forms; 27.4% of males and 48.9% of females reported all five forms. Results of this study support the viability of the CTQ-SF for screening maltreatment in a highly vulnerable street population. Caution is recommended when comparing prevalence estimates for male and female street youth given the failure of the strong factorial multigroup model.

Non-inferiority cancer clinical trials: scope and purposes underlying their design.

PubMed

Riechelmann, R P; Alex, A; Cruz, L; Bariani, G M; Hoff, P M

2013-07-01

Non-inferiority clinical trials (NIFCTs) aim to demonstrate that the experimental therapy has advantages over the standard of care, with acceptable loss of efficacy. We evaluated the purposes underlying the selection of a non-inferiority design in oncology and the size of their non-inferiority margins (NIFm's). All NIFCTs of cancer-directed therapies and supportive care agents published in a 10-year period were eligible. Two investigators extracted the data and independently classified the trials by their purpose to choose a non-inferiority design. Seventy-five were included: 43% received funds from industry, overall survival was the most common primary end point and 73% reported positive results. The most frequent purposes underlying the selection of a non-inferiority design were to test more conveniently administered schedules and/or less toxic treatments. In 13 (17%) trials, a clear purpose was not identified. Among the trials that reported a pre-specified NIFm, the median value was 12.5% (range 4%-25%) for trials with binary primary end points and Hazard Ratio of 1.25 (range 1.10-1.50) for trials that used time-to-event primary outcomes. Cancer NIFCT harbor serious methodological and ethical issues. Many use large NIFm and nearly one-fifth did not state a clear purpose for selecting a non-inferiority design.

Ultra-sensitive LC-MS/MS method for the quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine in human plasma for a microdose clinical trial.

PubMed

van Nuland, M; Hillebrand, M J X; Rosing, H; Burgers, J A; Schellens, J H M; Beijnen, J H

2018-03-20

In microdose clinical trials a maximum of 100 μg of drug substance is administered to participants, in order to determine the pharmacokinetic properties of the agents. Measuring low plasma concentrations after administration of a microdose is challenging and requires the use of ulta-sensitive equipment. Novel liquid chromatography-mass spectrometry (LC-MS/MS) platforms can be used for quantification of low drug plasma levels. Here we describe the development and validation of an LC-MS/MS method for quantification of gemcitabine and its metabolite 2',2'-difluorodeoxyuridine (dFdU) in the low picogram per milliliter range to support a microdose trial. The validated assay ranges from 2.5-500 pg/mL for gemcitabine and 250-50,000 pg/mL for dFdU were linear, with a correlation coefficient (r 2 ) of 0.996 or better. Sample preparation with solid phase extraction provided a good and reproducible recovery. All results were within the acceptance criteria of the latest US FDA guidance and EMA guidelines. In addition, the method was successfully applied to measure plasma concentrations of gemcitabine in a patient after administration of a microdose of gemcitabine. Copyright © 2017 Elsevier B.V. All rights reserved.

The Acceptability of Acupuncture for Low Back Pain: A Qualitative Study of Patient’s Experiences Nested within a Randomised Controlled Trial

PubMed Central

Hopton, Ann; Thomas, Kate; MacPherson, Hugh

2013-01-01

Introduction The National Institute for Health and Clinical Excellence guidelines recommend acupuncture as a clinically effective treatment for chronic back pain. However, there is insufficient knowledge of what factors contribute to patients’ positive and negative experiences of acupuncture, and how those factors interact in terms of the acceptability of treatment. This study used patient interviews following acupuncture treatment for back pain to identify, understand and describe the elements that contribute or detract from acceptability of treatment. Methods The study used semi-structured interviews. Twelve patients were interviewed using an interview schedule as a sub-study nested within a randomised controlled trial of acupuncture for chronic back pain. The interviews were analysed using thematic analysis. Results and Discussion Three over-arching themes emerged from the analysis. The first entitled facilitators of acceptability contained five subthemes; experience of pain relief, improvements in physical activity, relaxation, psychological benefit, reduced reliance on medication. The second over-arching theme identified barriers to acceptability, which included needle-related discomfort and temporary worsening of symptoms, pressure to continue treatment and financial cost. The third over-arching theme comprised mediators of acceptability, which included pre-treatment mediators such as expectation and previous experience, and treatment-related mediators of time, therapeutic alliance, lifestyle advice and the patient’s active involvement in recovery. These themes inform our understanding of the acceptability of acupuncture to patients with low back pain. Conclusion The acceptability of acupuncture treatment for low back pain is complex and multifaceted. The therapeutic relationship between the practitioner and patient emerged as a strong driver for acceptability, and as a useful vehicle to develop the patients’ self-efficacy in pain management in the longer term. Unpleasant treatment related effects do not necessarily detract from patients’ overall perception of acceptability. PMID:23437246

Using Mindfulness- and Acceptance-Based Treatments With Clients From Nondominant Cultural and/or Marginalized Backgrounds: Clinical Considerations, Meta-Analysis Findings, and Introduction to the Special Series.

PubMed

Fuchs, Cara; Lee, Jonathan K; Roemer, Lizabeth; Orsillo, Susan M

2013-02-01

A growing body of research suggests that mindfulness- and acceptance-based principles can increase efforts aimed at reducing human suffering and increasing quality of life. A critical step in the development and evaluation of these new approaches to treatment is to determine the acceptability and efficacy of these treatments for clients from nondominant cultural and/or marginalized backgrounds. This special series brings together the wisdom of clinicians and researchers who are currently engaged in clinical practice and treatment research with populations who are historically underrepresented in the treatment literature. As an introduction to the series, this paper presents a theoretical background and research context for the papers in the series, highlights the elements of mindfulness- and acceptance-based treatments that may be congruent with culturally responsive treatment, and briefly outlines the general principles of cultural competence and responsive treatment. Additionally, the results of a meta-analysis of mindfulness- and acceptance-based treatments with clients from nondominant cultural and/or marginalized backgrounds are presented. Our search yielded 32 studies totaling 2,198 clients. Results suggest small (Hedges' g=.38, 95% CI=.11 - .64) to large (Hedges' g=1.32, 95% CI=.61 - 2.02) effect sizes for mindfulness- and acceptance-based treatments, which varied by study design.

Acceptability of cancer chemoprevention trials: impact of the design

PubMed Central

Maisonneuve, Anne-Sophie; Huiart, Laetitia; Rabayrol, Laetitia; Horsman, Doug; Didelot, Remi; Sobol, Hagay; Eisinger, Francois

2008-01-01

Background: Chemoprevention could significantly reduce cancer burden. Assessment of efficacy and risk/benefit balance is at best achieved through randomized clinical trials. Methods: At a periodic health examination center 1463 adults were asked to complete a questionnaire about their willingness to be involved in different kinds of preventive clinical trials. Results: Among the 851 respondents (58.2%), 228 (26.8%) agreed to participate in a hypothetical chemoprevention trial aimed at reducing the incidence of lung cancer and 116 (29.3%) of 396 women agreed to a breast cancer chemoprevention trial. Randomization would not restrain participation (acceptability rate: 87.7% for lung cancer and 93.0% for breast cancer). In these volunteers, short-term trials (1 year) reached a high level of acceptability: 71.5% and 73.7% for lung and breast cancer prevention respectively. In contrast long-term trials (5 years or more) were far less acceptable: 9.2% for lung cancer (OR=7.7 CI95% 4.4-14.0) and 10.5 % for breast cancer (OR=6.9 CI95% 3.2-15.8). For lung cancer prevention, the route of administration impacts on acceptability with higher rate 53.1% for a pill vs. 7.9% for a spray (OR=6.7 CI95% 3.6-12.9). Conclusion: Overall healthy individuals are not keen to be involved in chemo-preventive trials, the design of which could however increase the acceptability rate. PMID:18769562

Reliability of the method of levels for determining cutaneous temperature sensitivity

NASA Astrophysics Data System (ADS)

Jakovljević, Miroljub; Mekjavić, Igor B.

2012-09-01

Determination of the thermal thresholds is used clinically for evaluation of peripheral nervous system function. The aim of this study was to evaluate reliability of the method of levels performed with a new, low cost device for determining cutaneous temperature sensitivity. Nineteen male subjects were included in the study. Thermal thresholds were tested on the right side at the volar surface of mid-forearm, lateral surface of mid-upper arm and front area of mid-thigh. Thermal testing was carried out by the method of levels with an initial temperature step of 2°C. Variability of thermal thresholds was expressed by means of the ratio between the second and the first testing, coefficient of variation (CV), coefficient of repeatability (CR), intraclass correlation coefficient (ICC), mean difference between sessions (S1-S2diff), standard error of measurement (SEM) and minimally detectable change (MDC). There were no statistically significant changes between sessions for warm or cold thresholds, or between warm and cold thresholds. Within-subject CVs were acceptable. The CR estimates for warm thresholds ranged from 0.74°C to 1.06°C and from 0.67°C to 1.07°C for cold thresholds. The ICC values for intra-rater reliability ranged from 0.41 to 0.72 for warm thresholds and from 0.67 to 0.84 for cold thresholds. S1-S2diff ranged from -0.15°C to 0.07°C for warm thresholds, and from -0.08°C to 0.07°C for cold thresholds. SEM ranged from 0.26°C to 0.38°C for warm thresholds, and from 0.23°C to 0.38°C for cold thresholds. Estimated MDC values were between 0.60°C and 0.88°C for warm thresholds, and 0.53°C and 0.88°C for cold thresholds. The method of levels for determining cutaneous temperature sensitivity has acceptable reliability.

[The application of subjective visual gravity in assessment of vestibular compensation: a pilot study].

PubMed

Zhao, Yuan; Chen, Taisheng; Wang, Wei; Xu, Kaixu; Wen, Chao; Liu, Qiang; Han, Xi; Li, Shanshan; Li, Xiaojie; Lin, Peng

2016-05-01

To discuss the characteristics of subjective visual gravity (subjective visual vertical/horizontal, SVV/SVH) and assess its clinical application for peripheral unilateral vestibular compensation. 69 cases of acute peripheral unilateral vestibular dysfunction patients (case group) accepted SVV/SVH, spontaneous nystagmus (SN), caloric test (CT) and other vestibular function tests. 49 healthy people (control group) accepted SVV/SVH only. SVV/SVH, SN and unilateral weakness (UW) were selected as for the observation indicators. The correlations between SVV/SVH, SN, UW and courses were investigated respectively, as well as the characteristic of SVV/SVH, SN in period of vestibular compensation. Among case group SVV, SVH positive in 42 patients(60.9%) and 44 patients(63.8%), the absolute values of the skew angle were in the range between 2.1°-20.0°, 2.1°-22.2°. Skew angles of SVV/SVH in control were in the range between -1.5°-2.0° and -2.0°-1.6°, and had no statistical significance with case group(t=5.336 and 5.864, P<0.05). SN-positive 28 cases (40.6%), the range of intensities at 2.4°-17.1°; UW-positive 50 cases (72.5%). In case group, positive correlation between SVV and SVH(r=0.948, P=0.00), negatively correlated between SVV/SVH and SN respectively(r values were -0.720, -0.733, P values were 0.00), no correlation between the skew angle of SVV/SVH, strength of SN and UW value(r values were 0.191, 0.189, and 0.179, P>0.05), there was no correlation between the absolute value of SVV, SVH, SN, UW with the duration (rs values were -0.075, -0.065, -0.212, and 0.126, P>0.05). Subjective visual gravity can be used not only to assess the range of unilateral peripheral vestibular dysfunction, but also help assess the static compensatory of otolithic, guidance and assessment of vestibular rehabilitation.

Basic psychometric properties of the transfer assessment instrument (version 3.0).

PubMed

Tsai, Chung-Ying; Rice, Laura A; Hoelmer, Claire; Boninger, Michael L; Koontz, Alicia M

2013-12-01

To refine the Transfer Assessment Instrument (TAI 2.0), develop a training program for the TAI, and analyze the basic psychometric properties of the TAI 3.0, including reliability, standard error of measurement (SEM), minimal detectable change (MDC), and construct validity. Repeated measures. A winter sports clinic for disabled veterans. Wheelchair users (N=41) who perform sitting-pivot or standing-pivot transfers. Not applicable. TAI version 3.0, intraclass correlation coefficients, SEMs, and MDCs for reliable measurement of raters' responses. Spearman correlation coefficient, 1-way analysis of variance, and independent t tests to evaluate construct validity. TAI 3.0 had acceptable to high levels of reliability (range, .74-.88). The SEMs for part 1, part 2, and final scores ranged from .45 to .75. The MDC was 1.5 points on the 10-point scale for the final score. There were weak correlations (ρ range, -.13 to .25; P>.11) between TAI final scores and subjects' characteristics (eg, sex, body mass index, age, type of disability, length of wheelchair use, grip and elbow strength, sitting balance). With comprehensive training, the refined TAI 3.0 yields high reliability among raters of different clinical backgrounds and experience. TAI 3.0 was unbiased toward certain physical characteristics that may influence transfer. TAI fills a void in the field by providing a quantitative measurement of transfers and a tool that can be used to detect problems and guide transfer training. Copyright © 2013 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A novel non-imaging optics based Raman spectroscopy device for transdermal blood analyte measurement

PubMed Central

Kong, Chae-Ryon; Barman, Ishan; Dingari, Narahara Chari; Kang, Jeon Woong; Galindo, Luis; Dasari, Ramachandra R.; Feld, Michael S.

2011-01-01

Due to its high chemical specificity, Raman spectroscopy has been considered to be a promising technique for non-invasive disease diagnosis. However, during Raman excitation, less than one out of a million photons undergo spontaneous Raman scattering and such weakness in Raman scattered light often require highly efficient collection of Raman scattered light for the analysis of biological tissues. We present a novel non-imaging optics based portable Raman spectroscopy instrument designed for enhanced light collection. While the instrument was demonstrated on transdermal blood glucose measurement, it can also be used for detection of other clinically relevant blood analytes such as creatinine, urea and cholesterol, as well as other tissue diagnosis applications. For enhanced light collection, a non-imaging optical element called compound hyperbolic concentrator (CHC) converts the wide angular range of scattered photons (numerical aperture (NA) of 1.0) from the tissue into a limited range of angles accommodated by the acceptance angles of the collection system (e.g., an optical fiber with NA of 0.22). A CHC enables collimation of scattered light directions to within extremely narrow range of angles while also maintaining practical physical dimensions. Such a design allows for the development of a very efficient and compact spectroscopy system for analyzing highly scattering biological tissues. Using the CHC-based portable Raman instrument in a clinical research setting, we demonstrate successful transdermal blood glucose predictions in human subjects undergoing oral glucose tolerance tests. PMID:22125761

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial.

PubMed

Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

2015-09-18

To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. NCT02044172; ISRCTN20141297. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Establishing nurse-led active surveillance for men with localised prostate cancer: development and formative evaluation of a model of care in the ProtecT trial

PubMed Central

Wade, Julia; Holding, Peter N; Bonnington, Susan; Rooshenas, Leila; Lane, J Athene; Salter, C Elizabeth; Tilling, Kate; Speakman, Mark J; Brewster, Simon F; Evans, Simon; Neal, David E; Hamdy, Freddie C; Donovan, Jenny L

2015-01-01

Objectives To develop a nurse-led, urologist-supported model of care for men managed by active surveillance or active monitoring (AS/AM) for localised prostate cancer and provide a formative evaluation of its acceptability to patients, clinicians and nurses. Nurse-led care, comprising an explicit nurse-led protocol with support from urologists, was developed as part of the AM arm of the Prostate testing for cancer and Treatment (ProtecT) trial. Design Interviews and questionnaire surveys of clinicians, nurses and patients assessed acceptability. Setting Nurse-led clinics were established in 9 centres in the ProtecT trial and compared with 3 non-ProtecT urology centres elsewhere in UK. Participants Within ProtecT, 22 men receiving AM nurse-led care were interviewed about experiences of care; 11 urologists and 23 research nurses delivering ProtecT trial care completed a questionnaire about its acceptability; 20 men managed in urology clinics elsewhere in the UK were interviewed about models of AS/AM care; 12 urologists and three specialist nurses working in these clinics were also interviewed about management of AS/AM. Results Nurse-led care was commended by ProtecT trial participants, who valued the flexibility, accessibility and continuity of the service and felt confident about the quality of care. ProtecT consultant urologists and nurses also rated it highly, identifying continuity of care and resource savings as key attributes. Clinicians and patients outside the ProtecT trial believed that nurse-led care could relieve pressure on urology clinics without compromising patient care. Conclusions The ProtecT AM nurse-led model of care was acceptable to men with localised prostate cancer and clinical specialists in urology. The protocol is available for implementation; we aim to evaluate its impact on routine clinical practice. Trial registration numbers NCT02044172; ISRCTN20141297. PMID:26384727

Welcome to Journal of Foot and Ankle Research: a new open access journal for foot health professionals

PubMed Central

Menz, Hylton B; Potter, Mike J; Borthwick, Alan M; Landorf, Karl B

2008-01-01

Journal of Foot and Ankle Research (JFAR) is a new, open access, peer-reviewed online journal that encompasses all aspects of policy, organisation, delivery and clinical practice related to the assessment, diagnosis, prevention and management of foot and ankle disorders. JFAR will cover a wide range of clinical subject areas, including diabetology, paediatrics, sports medicine, gerontology and geriatrics, foot surgery, physical therapy, dermatology, wound management, radiology, biomechanics and bioengineering, orthotics and prosthetics, as well the broad areas of epidemiology, policy, organisation and delivery of services related to foot and ankle care. The journal encourages submission from all health professionals who manage lower limb conditions, including podiatrists, nurses, physical therapists and physiotherapists, orthopaedists, manual therapists, medical specialists and general medical practitioners, as well as health service researchers concerned with foot and ankle care. All manuscripts will undergo open peer review, and all accepted manuscripts will be freely available on-line using the open access platform of BioMed Central. PMID:18822156

Clinical evaluation of total intravenous anesthesia using a combination of propofol and medetomidine following anesthesia induction with medetomidine, guaifenesin and propofol for castration in Thoroughbred horses.

PubMed

Oku, Kazuomi; Kakizaki, Masashi; Ono, Keiichi; Ohta, Minoru

2011-12-01

Seven Thoroughbred horses were castrated under total intravenous anesthesia (TIVA) using propofol and medetomidine. After premedication with medetomidine (5.0 µg/kg, intravenously), anesthesia was induced with guaifenesin (100 mg/kg, intravenously) and propofol (3.0 mg/kg, intravenously) and maintained with constant rate infusions of medetomidine (0.05 µg/kg/min) and propofol (0.1 mg/kg/min). Quality of induction was judged excellent to good. Three horses showed insufficient anesthesia and received additional anesthetic. Arterial blood pressure changed within an acceptable range in all horses. Decreases in respiratory rate and hypercapnia were observed in all horses. Three horses showed apnea within a short period of time. Recovery from anesthesia was calm and smooth in all horses. The TIVA-regimen used in this study provides clinically effective anesthesia for castration in horses. However, assisted ventilation should be considered to minimize respiratory depression.

Design and development of a sensorized wireless toy for measuring infants' manual actions.

PubMed

Serio, Stefano Marco; Cecchi, Francesca; Assaf, Tareq; Laschi, Cecilia; Dario, Paolo

2013-05-01

The development of grasping is an important milestone that infants encounter during the first months of life. Novel approaches for measuring infants' manual actions are based on sensorized platform usable in natural settings, such as instrumented wireless toys that could be exploited for diagnosis and rehabilitation purposes. A new sensorized wireless toy has been designed and developed with embedded pressure sensors and audio-visual feedback. The fulfillment of clinical specifications has been proved through mechanical and electrical characterization. Infants showed a good grade of acceptance to such kind of tools, as confirmed by the results of preliminary tests that involved nine healthy infants: the dimensions fulfill infants' anthropometrics, the device is robust and safe, the acquired signals are in the expected range and the wireless communication is stable. Although achieved only through preliminary tests, such results confirm the hypothesis that this typology of instrumented toys could be useful for quantitative monitoring and measuring infants' motor development and ready to be evaluated for assessing motor skills through appropriate clinical trials.

Incidence and 12-month outcome of non-transient childhood conversion disorder in the U.K. and Ireland.

PubMed

Ani, Cornelius; Reading, Richard; Lynn, Richard; Forlee, Simone; Garralda, Elena

2013-06-01

Little is known about conversion disorder in childhood. To document clinical incidence, features, management and 12-month outcome of non-transient conversion disorder in under 16-year-olds in the U.K. and Ireland. Surveillance through the British Paediatric Surveillance Unit and Child and Adolescent Psychiatry Surveillance System. In total, 204 cases (age range 7-15 years) were reported, giving a 12-month incidence of 1.30/100 000 (95% CI 1.11-1.52). The most common symptoms were motor weakness and abnormal movements. Presentation with multiple symptoms was the norm. Antecedent stressors were reported for 80.8%, most commonly bullying in school. Most children required in-patient admission with frequent medical investigations. Follow-up at 12 months was available for 147 children, when all conversion disorder symptoms were reported as improved. Most families (91%) accepted a non-medical explanation of the symptoms either fully or partially. Childhood conversion disorder represents an infrequent but significant clinical burden in the UK and Ireland.

[Quality and compliance with Clinical Practice Guidelines of Chronic Noncommunicable Diseases in primary care].

PubMed

Poblano-Verástegui, Ofelia; Vieyra-Romero, Waldo I; Galván-García, Ángel F; Fernández-Elorriaga, María; Rodríguez-Martínez, Antonia I; Saturno-Hernández, Pedro J

2017-01-01

To assess the quality and compliance of clinical practice guidelines (CPG) applicable to chronic non-communicable diseases (CNCD) in primary healthcare (CS), and views of staff on the barriers, facilitators and their use. 18 valued CPG with AGREEII, 3 are selected to develop indicators and assess compliance using lot quality acceptance sample (LQAS, standard 75 / 95% threshold 40 / 75% respectively, α:0. 05, β:0. 10) on 5 CS. 70 professionals surveyed about knowledge and use of CPG. Average quality of the CPG was 57.2%; low rating in domains: "Applicability" (<25%), "Stakeholder involvement" (43.5%) and "Rigour of development" (55.0%). Compliance in CS ranges from 39 to 53.4%. Professionals show uneven knowledge of CPG; 44 to 45% (according to CPG), they declare that they are not used, they identify as main barriers the lack of training, and their difficult accessibility and management. The quality and implementation of evaluated CPG is deficient constituting an opportunity of improvement in health services.

[Dislocated fracture of the lesser trochanter with malrotation of the stem after robot assisted implantation of a cementless hip prosthesis: a casuistic report].

PubMed

Prymka, M; Hassenpflug, J

2003-08-01

This paper presents the case of a 63 year old female with a severe coxarthrosis. She got a robot assited implantation of a cementless hip prosthesis (Osteolock, Stryker-Howmedica, Mühlheim). As operation robot the CASPAR-System (Orto-Maquet, Rastatt) was used. Initially, the clinical progress of the patient was fine. She was nearly painfree within 14 days and showed an acceptable range of motion in the operated joint (flexion/ extension 90 degrees /05 degrees /00 degrees ). She was mobilized with crutches and 15 kg weight bearing at the operated leg. 3 weeks postoperative the patient complaint about increasing pain without trauma or intensification of the weight bearing. X-rays showed not only a dislocated fracture of the lesser trochanter, but also a sinking combined with a malrotation of the stem. A revision operation was necessary,where we implanted a cemented stem. Now clinical progress was completely satisfying.

Herbal Products: Benefits, Limits, and Applications in Chronic Liver Disease

PubMed Central

Del Prete, Anna; Scalera, Antonella; Iadevaia, Maddalena Diana; Miranda, Agnese; Zulli, Claudio; Gaeta, Laura; Tuccillo, Concetta; Federico, Alessandro; Loguercio, Carmelina

2012-01-01

Complementary and alternative medicine soughts and encompasses a wide range of approaches; its use begun in ancient China at the time of Xia dynasty and in India during the Vedic period, but thanks to its long-lasting curative effect, easy availability, natural way of healing, and poor side-effects it is gaining importance throughout the world in clinical practice. We conducted a review describing the effects and the limits of using herbal products in chronic liver disease, focusing our attention on those most known, such as quercetin or curcumin. We tried to describe their pharmacokinetics, biological properties, and their beneficial effects (as antioxidant role) in metabolic, alcoholic, and viral hepatitis (considering that oxidative stress is the common pathway of chronic liver diseases of different etiology). The main limit of applicability of CAM comes from the lacking of randomized, placebo-controlled clinical trials giving a real proof of efficacy of those products, so that anecdotal success and personal experience are frequently the driving force for acceptance of CAM in the population. PMID:22991573

Effect of testing experience and profession on provider acceptability of rapid HIV testing after implementation in public sexual health clinics in Sydney.

PubMed

Conway, D P; Guy, R; McNulty, A; Couldwell, D L; Davies, S C; Smith, D E; Keen, P; Cunningham, P; Holt, M

2015-05-01

Rapid HIV testing (RHT) is well established in many countries, but it is new in Australia since a policy change in 2011. We assessed service provider acceptability of RHT before and after its implementation in four Sydney public sexual health clinics. Service providers were surveyed immediately after training in RHT and again 6-12 months later. Differences in mean scores between survey rounds were assessed via t-tests, with stratification by profession and the number of tests performed. RHT was rated as highly acceptable among staff at baseline and acceptability scores improved between survey rounds. Belief in being sufficiently skilled and experienced to perform RHT (P = 0.004) and confidence in the delivery of nonreactive results increased (P = 0.007), while the belief that RHT was disruptive declined (P = 0.001). Acceptability was higher for staff who had performed a greater number of tests regarding comfort with their role in RHT (P = 0.004) and belief that patients were satisfied with RHT (P = 0.007). Compared with nurses, doctors had a stronger preference for a faster rapid test (P = 0.027) and were more likely to agree that RHT interfered with consultations (P = 0.014). Differences in responses between professions may reflect differences in staff roles, the type of patients seen by staff and the model of testing used, all of which may affect the number of tests performed by staff. These findings may inform planning for how best to implement RHT in clinical services. © 2015 British HIV Association.

Artificial pancreas (AP) clinical trial participants' acceptance of future AP technology.

PubMed

Bevier, Wendy C; Fuller, Serena M; Fuller, Ryan P; Rubin, Richard R; Dassau, Eyal; Doyle, Francis J; Jovanovič, Lois; Zisser, Howard C

2014-09-01

Artificial pancreas (AP) systems are currently an active field of diabetes research. This pilot study examined the attitudes of AP clinical trial participants toward future acceptance of the technology, having gained firsthand experience. After possible influencers of AP technology adoption were considered, a 34-question questionnaire was developed. The survey assessed current treatment satisfaction, dimensions of clinical trial participant motivation, and variables of the technology acceptance model (TAM). Forty-seven subjects were contacted to complete the survey. The reliability of the survey scales was tested using Cronbach's α. The relationship of the factors to the likelihood of AP technology adoption was explored using regression analysis. Thirty-six subjects (76.6%) completed the survey. Of the respondents, 86.1% were either highly likely or likely to adopt the technology once available. Reliability analysis of the survey dimensions revealed good internal consistency, with scores of >0.7 for current treatment satisfaction, convenience (motivation), personal health benefit (motivation), perceived ease of use (TAM), and perceived usefulness (TAM). Linear modeling showed that future acceptance of the AP was significantly associated with TAM and the motivation variables of convenience plus the individual item benefit to others (R(2)=0.26, P=0.05). When insulin pump and continuous glucose monitor use were added, the model significance improved (R(2)=0.37, P=0.02). This pilot study demonstrated that individuals with direct AP technology experience expressed high likelihood of future acceptance. Results support the factors of personal benefit, convenience, perceived usefulness, and perceived ease of use as reliable scales that suggest system adoption in this highly motivated patient population.

Malnutrition in Hospitalized Pediatric Patients: Assessment, Prevalence, and Association to Adverse Outcomes.

PubMed

Daskalou, Efstratia; Galli-Tsinopoulou, Assimina; Karagiozoglou-Lampoudi, Thomais; Augoustides-Savvopoulou, Persefone

2016-01-01

Malnutrition is a frequent finding in pediatric health care settings in the form of undernutrition or excess body weight. Its increasing prevalence and impact on overall health status, which is reflected in the adverse outcomes, renders imperative the application of commonly accepted and evidence-based practices and tools by health care providers. Nutrition risk screening on admission and nutrition status evaluation are key points during clinical management of hospitalized pediatric patients, in order to prevent health deterioration that can lead to serious complications and growth consequences. In addition, anthropometric data based on commonly accepted universal growth standards can give accurate results for nutrition status. Both nutrition risk screening and nutrition status assessment are techniques that should be routinely implemented, based on commonly accepted growth standards and methodology, and linked to clinical outcomes. The aim of the present review was to address the issue of hospital malnutrition in pediatric settings in terms of prevalence, outline nutrition status evaluation and nutrition screening process using different criteria and available tools, and present its relationship with outcome measures. Key teaching points • Malnutrition-underweight or excess body weight-is a frequent imbalance in pediatric settings that affects physical growth and results in undesirable clinical outcomes. • Anthropometry interpretation through growth charts and nutrition screening are cornerstones for the assessment of malnutrition.To date no commonly accepted anthropometric criteria or nutrition screening tools are used in hospitalized pediatric patients. • Commonly accepted nutrition status and screening processes based on the World Health Organization's growth standards can contribute to the overall hospital nutrition care of pediatric patients.

Acceptability and perceived barriers and facilitators to creating a national research register to enable ’direct to patient’ enrolment into research: the Scottish Health Research Register (SHARE)

PubMed Central

2013-01-01

Background Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. Methods We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. Results The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. Conclusions This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers. PMID:24139174

Evaluation of a Multidrug Assay for Monitoring Adherence to a Regimen for HIV Preexposure Prophylaxis in a Clinical Study, HIV Prevention Trials Network 073.

PubMed

Zhang, Yinfeng; Clarke, William; Marzinke, Mark A; Piwowar-Manning, Estelle; Beauchamp, Geetha; Breaud, Autumn; Hendrix, Craig W; Cloherty, Gavin A; Emel, Lynda; Rose, Scott; Hightow-Weidman, Lisa; Siegel, Marc; Shoptaw, Steven; Fields, Sheldon D; Wheeler, Darrell; Eshleman, Susan H

2017-07-01

Daily oral tenofovir disoproxil fumarate (TDF)-emtricitabine (FTC) is a safe and effective intervention for HIV preexposure prophylaxis (PrEP). We evaluated the performance of a qualitative assay that detects 20 antiretroviral (ARV) drugs (multidrug assay) in assessing recent PrEP exposure (detection limit, 2 to 20 ng/ml). Samples were obtained from 216 Black men who have sex with men (208 HIV-uninfected men and 8 seroconverters) who were enrolled in a study in the United States evaluating the acceptability of TDF-FTC PrEP (165 of the uninfected men and 5 of the seroconverters accepted PrEP). Samples from 163 of the 165 HIV-uninfected men who accepted PrEP and samples from all 8 seroconverters were also tested for tenofovir (TFV) and FTC using a quantitative assay (detection limit for both drugs, 0.31 ng/ml). HIV drug resistance was assessed in seroconverter samples. The multidrug assay detected TFV and/or FTC in 3 (1.4%) of the 208 uninfected men at enrollment, 84 (40.4%) of the 208 uninfected men at the last study visit, and 1 (12.5%) of the 8 seroconverters. No other ARV drugs were detected. The quantitative assay confirmed all positive results from the multidrug assay and detected TFV and/or FTC in 9 additional samples (TFV range, 0.65 to 16.5 ng/ml; FTC range, 0.33 to 14.6 ng/ml). Resistance mutations were detected in 4 of the 8 seroconverter samples. The multidrug assay had 100% sensitivity and specificity for detecting TFV and FTC at drug concentrations consistent with daily PrEP use. The quantitative assay detected TFV and FTC at lower levels, which also might have provided protection against HIV infection. Copyright © 2017 American Society for Microbiology.

Acceptability and perceived barriers and facilitators to creating a national research register to enable 'direct to patient' enrolment into research: the Scottish Health Research Register (SHARE).

PubMed

Grant, Aileen; Ure, Jenny; Nicolson, Donald J; Hanley, Janet; Sheikh, Aziz; McKinstry, Brian; Sullivan, Frank

2013-10-18

Difficulties with recruitment pose a major, increasingly recognised challenge to the viability of research. We sought to explore whether a register of volunteers interested in research participation, with data linkage to electronic health records to identify suitable research participants, would prove acceptable to healthcare staff, patients and researchers. We undertook a qualitative study in which a maximum variation sampling approach was adopted. Focus groups and interviews were conducted with patients, general practitioners (GP), practice managers and health service researchers in two Scottish health boards. Analysis was primarily thematic to identify a range of issues and concerns for all stakeholder groups. The concept of a national research register was, in general, acceptable to all stakeholder groups and was widely regarded as beneficial for research and for society. Patients, however, highlighted a number of conditions which should be met in the design of a register to expedite confidence and facilitate recruitment. They also gave their perceptions on how a register should operate and be promoted, favouring a range of media. GPs and practice managers were primarily concerned with the security and confidentiality of patient data and the impact a register may have on their workload. Researchers were supportive of the initiative seeing advantages in more rapid access to a wider pool of patients. They did raise concerns that GPs may be able to block access to personal patient data held in general practice clinical systems and that the register may not be representative of the whole population. This work suggests that patients, healthcare staff and researchers have a favourable view of the potential benefits of a national register to identify people who are potentially eligible and willing to participate in health related research. It has highlighted a number of issues for the developers to incorporate in the design of research registers.

Characterization of a 0.35T MR system for phantom image quality stability and in vivo assessment of motion quantification

PubMed Central

Saenz, Daniel L.; Yan, Yue; Christensen, Neil; Henzler, Margaret A.; Forrest, Lisa J.; Bayouth, John E.

2015-01-01

ViewRay is a novel MR‐guided radiotherapy system capable of imaging in near real‐time at four frames per second during treatment using 0.35T field strength. It allows for improved gating techniques and adaptive radiotherapy. Three cobalt‐60 sources (∼15,000 Curies) permit multiple‐beam, intensity‐modulated radiation therapy. The primary aim of this study is to assess the imaging stability, accuracy, and automatic segmentation algorithm capability to track motion in simulated and in vivo targets. Magnetic resonance imaging (MRI) characteristics of the system were assessed using the American College of Radiology (ACR)‐recommended phantom and accreditation protocol. Images of the ACR phantom were acquired using a head coil following the ACR scanning instructions. ACR recommended T1‐ and T2‐weighted sequences were evaluated. Nine measurements were performed over a period of seven months, on just over a monthly basis, to establish consistency. A silicon dielectric gel target was attached to the motor via a rod. 40 mm total amplitude was used with cycles of 3 to 9 s in length in a sinusoidal trajectory. Trajectories of six moving clinical targets in four canine patients were quantified and tracked. ACR phantom images were analyzed, and the results were compared with the ACR acceptance levels. Measured slice thickness accuracies were within the acceptance limits. In the 0.35 T system, the image intensity uniformity was also within the ACR acceptance limit. Over the range of cycle lengths, representing a wide range of breathing rates in patients imaged at four frames/s, excellent agreement was observed between the expected and measured target trajectories. In vivo canine targets, including the gross target volume (GTV), as well as other abdominal soft tissue structures, were visualized with inherent MR contrast, allowing for preliminary results of target tracking. PACS number: 87.61.Tg PMID:26699552

Characterization of a 0.35T MR system for phantom image quality stability and in vivo assessment of motion quantification.

PubMed

Saenz, Daniel L; Yan, Yue; Christensen, Neil; Henzler, Margaret A; Forrest, Lisa J; Bayouth, John E; Paliwal, Bhudatt R

2015-11-08

ViewRay is a novel MR-guided radiotherapy system capable of imaging in near real-time at four frames per second during treatment using 0.35T field strength. It allows for improved gating techniques and adaptive radiotherapy. Three cobalt-60 sources (~ 15,000 Curies) permit multiple-beam, intensity-modulated radiation therapy. The primary aim of this study is to assess the imaging stability, accuracy, and automatic segmentation algorithm capability to track motion in simulated and in vivo targets. Magnetic resonance imaging (MRI) characteristics of the system were assessed using the American College of Radiology (ACR)-recommended phantom and accreditation protocol. Images of the ACR phantom were acquired using a head coil following the ACR scanning instructions. ACR recommended T1- and T2-weighted sequences were evaluated. Nine measurements were performed over a period of seven months, on just over a monthly basis, to establish consistency. A silicon dielectric gel target was attached to the motor via a rod. 40 mm total amplitude was used with cycles of 3 to 9 s in length in a sinusoidal trajectory. Trajectories of six moving clinical targets in four canine patients were quantified and tracked. ACR phantom images were analyzed, and the results were compared with the ACR acceptance levels. Measured slice thickness accuracies were within the acceptance limits. In the 0.35 T system, the image intensity uniformity was also within the ACR acceptance limit. Over the range of cycle lengths, representing a wide range of breathing rates in patients imaged at four frames/s, excellent agreement was observed between the expected and measured target trajectories. In vivo canine targets, including the gross target volume (GTV), as well as other abdominal soft tissue structures, were visualized with inherent MR contrast, allowing for preliminary results of target tracking.

Efficacy and safety of sarolaner (Simparica™) against fleas on dogs presented as veterinary patients in the United States.

PubMed

Cherni, Judith A; Mahabir, Sean P; Six, Robert H

2016-05-30

The efficacy and safety of a novel isoxazoline parasiticide, sarolaner (Simparica™), for the control of fleas on dogs was evaluated in a randomized, controlled clinical study conducted in 19 general veterinary practices throughout the United States. Four hundred and seventy nine (479) dogs from 293 households were enrolled. Each household was randomly assigned to treatment with either sarolaner oral tablets (Simparica™, Zoetis) at the proposed label dose or an approved comparator product at the label dose (spinosad, Comfortis(®), Elanco). Dogs were dosed by their owners at home on Day 0 and on approximately Days 30 and 60. Dogs were examined at the clinics for general health, flea and tick infestation, and clinical signs of flea allergy dermatitis (FAD) at the initial visit and Days 14, 30, 60 and 90. Blood was collected for clinical pathology at screening and Day 90. Sarolaner was well-accepted by dogs with the majority of flavored chewable tablets (91.5%) accepted free choice, by hand or in food. Geometric mean live flea counts were reduced by >99% at the first time measured (14 days) after initiation of treatment and continued to reduce through the study. Treatment success (proportion of dogs with ≥90% reduction in fleas) for the sarolaner-treated dogs was superior to that for spinosad-treated dogs at Days 14 and 30 and non-inferior on Days 60 and 90 (P≤0.025) The rapid reduction in flea infestations resulted in a similar rapid resolution of the clinical signs associated with FAD. Sarolaner chewable tablets were well tolerated with no treatment related adverse reactions. Most of the clinical signs reported were consistent with allergies and dermatitis or sporadic occurrences of conditions commonly observed in the general dog population. A wide variety of concomitant medications, including many commercially available heartworm preventatives and other anthelmintic drugs, were administered to study dogs and all were well tolerated. Sarolaner administered orally to provide a minimum dosage of 2.0mg/kg (range 2-4mg/kg) once monthly for three consecutive treatments was safe and effective in the treatment and prevention of natural infestations of fleas and resulted in a substantial improvement of clinical signs associated with FAD. Copyright © 2016. Published by Elsevier B.V.

People’s willingness to accept overdetection in cancer screening: population survey

PubMed Central

Jones, Caroline; Yang, Yaling; Oke, Jason; Hewitson, Paul

2015-01-01

Objectives To describe the level of overdetection people would find acceptable in screening for breast, prostate, and bowel cancer and whether acceptability is influenced by the magnitude of the benefit from screening and the cancer specific harms from overdetection. Design Online survey. Women were presented with scenarios on breast and bowel cancer, men with scenarios on prostate and bowel cancer. For each particular cancer, we presented epidemiological information and described the treatment and its consequences. Secondly, we presented two different scenarios of benefit: one indicating a 10% reduction in cancer specific mortality and the second indicating a 50% reduction. Setting Online survey of the population in the United Kingdom. Participants Respondents were part of an existing panel of people who volunteer for online research and were invited by email or online marketing. We recruited 1000 respondents, representative for age and sex for the UK population. Main outcome measures Number of cases of overdetection people were willing to accept, ranging from 0-1000 (complete screened population) for each cancer modality and each scenario of benefit. Results There was large variability between respondents in the level of overdetection they would find acceptable, with medians ranging from 113 to 313 cases of overdetection per 1000 people screened. Across all scenarios, 4-7% of respondents indicated they would accept no overdetection at all compared with 7-14% who thought that it would be acceptable for the entire screened population to be overdetected. Acceptability in screening for bowel cancer was significantly lower than for breast and prostate cancer. People aged 50 or over accepted significantly less overdetection, whereas people with higher education levels accepted more; 29% of respondents had heard of overdetection before. Conclusions Acceptability of overdetection in cancer screening is variable. Invitations for screening should include clear information on the likelihood and consequences of overdetection to allow people to make an informed choice. PMID:25736617

People's willingness to accept overdetection in cancer screening: population survey.

PubMed

Van den Bruel, Ann; Jones, Caroline; Yang, Yaling; Oke, Jason; Hewitson, Paul

2015-03-03

To describe the level of overdetection people would find acceptable in screening for breast, prostate, and bowel cancer and whether acceptability is influenced by the magnitude of the benefit from screening and the cancer specific harms from overdetection. Online survey. Women were presented with scenarios on breast and bowel cancer, men with scenarios on prostate and bowel cancer. For each particular cancer, we presented epidemiological information and described the treatment and its consequences. Secondly, we presented two different scenarios of benefit: one indicating a 10% reduction in cancer specific mortality and the second indicating a 50% reduction. Online survey of the population in the United Kingdom. Respondents were part of an existing panel of people who volunteer for online research and were invited by email or online marketing. We recruited 1000 respondents, representative for age and sex for the UK population. Number of cases of overdetection people were willing to accept, ranging from 0-1000 (complete screened population) for each cancer modality and each scenario of benefit. There was large variability between respondents in the level of overdetection they would find acceptable, with medians ranging from 113 to 313 cases of overdetection per 1000 people screened. Across all scenarios, 4-7% of respondents indicated they would accept no overdetection at all compared with 7-14% who thought that it would be acceptable for the entire screened population to be overdetected. Acceptability in screening for bowel cancer was significantly lower than for breast and prostate cancer. People aged 50 or over accepted significantly less overdetection, whereas people with higher education levels accepted more; 29% of respondents had heard of overdetection before. Acceptability of overdetection in cancer screening is variable. Invitations for screening should include clear information on the likelihood and consequences of overdetection to allow people to make an informed choice. © Van den Bruel et al 2015.

Clinical and Para Clinical Information Needs of Infertility Electronic Health Records in Iran: A Delphi Study.

PubMed

Farzandipour, Mehrdad; Jeddi, Fateme Rangraz; Gilasi, Hamid Reza; Shirzadi, Diana

2017-09-01

infertility is referred to the person's inability to conceive pregnancy after one year of intercourse without using protection. This study paves the ground for creating a complete, united, and coherent source of patients' medical information. this is an applied research of descriptive-cross sectional type which has been carried out through qualitative - quantitative methods. The sample of the present study was 50 specialists in the field of infertility which has been chosen based on purposive sampling method. Designing the questionnaire was done based on library studies and Gathering experts' views was done based on Delphi technique. 261 items from clinical and Para clinical information of infertile patients' electronic health records were subjected to an opinion poll by experts. During this process 223 items were accepted and 38 items have been rejected after two sessions of surveys by infertility experts. Para clinical information section consisted of 57 items that all of them have been accepted by the experts. Also, clinical information section consisted of 242 items from which 204 items were accepted and 38 items were rejected by the experts. existence of a structured electronic record system of infertile patients' information leads to the integration of patients' information, improvement of health care services and a decrease in treatment costs: all working to increase information safety. Furthermore, only essential and relevant information would be provided for the specialists and it will facilitate and direct the future infertility related studies due to the coherence, unity and relevance of the information.

Evaluating a web-based test results system at an urban STI clinic.

PubMed

Ling, Sarah B; Richardson, Douglas B; Mettenbrink, Christie J; Westergaard, Benton C; Sapp-Jones, Terri D; Crane, Lori A; Nyquist, Ann-Christine; McFarlane, Mary; Kachur, Rachel; Rietmeijer, Cornelis A

2010-04-01

Notifying patients of gonorrhea and chlamydia test results using online services may improve clinic efficiency and increase receipt of test results. This study evaluated the implementation of an online results system in an urban sexually transmitted infections clinic. Using the clinic's electronic medical records system to assess if and how gonorrhea and chlamydia test results were obtained, 3 time periods were examined between December 2007 and April 2009: period 1, six months before initiation of the online results system; Period 2, six months when patients could opt in for online results by creating their own access codes; and Period 3, four months when access codes were assigned. In addition, a survey was conducted to assess reasons for accepting or declining the online results system. A total of 9056 new patient visits were evaluated. During periods 1, 2, and 3, respectively 67%, 67%, and 70% patients received results either online or by telephone (NS). The proportion of patients calling the clinic for results decreased from 67% in period 1, to 51% in period 2, and 36% in period 3 (P < 0.0001). Survey results indicated that patients accepted online results primarily because of the ability to check results anytime of day. Reasons for not accepting results online included lack of Internet access or a preference to receive results via the telephone. The online results system decreased the number of phone calls to the clinic pertaining to STI test results, but had no effect on the overall proportion of patients receiving results.

Evaluation of immunoturbidimetric rheumatoid factor method from Diagam on Abbott c8000 analyzer: comparison with immunonephelemetric method.

PubMed

Dupuy, Anne Marie; Hurstel, Rémy; Bargnoux, Anne Sophie; Badiou, Stéphanie; Cristol, Jean Paul

2014-01-01

Rheumatoid factor (RF) consists of autoantibodies and because of its heterogeneity its determination is not easy. Currently, nephelometry and Elisa method are considered as reference methods. Due to consolidation, many laboratories have fully automated turbidimetric apparatus, and specific nephelemetric systems are not always available. In addition, nephelemetry is more accurate, but time consuming, expensive, and requires a specific device, resulting in a lower efficiency. Turbidimetry could be an attractive alternative. The turbidimetric RF test from Diagam meets the requirements of accuracy and precision for optimal clinical use, with an acceptable measuring range, and could be an alternative in the determination of RF, without the associated cost of a dedicated instrument, making consolidation and saving blood possible.

Simulation in teaching regional anesthesia: current perspectives.

PubMed

Udani, Ankeet D; Kim, T Edward; Howard, Steven K; Mariano, Edward R

2015-01-01

The emerging subspecialty of regional anesthesiology and acute pain medicine represents an opportunity to evaluate critically the current methods of teaching regional anesthesia techniques and the practice of acute pain medicine. To date, there have been a wide variety of simulation applications in this field, and efficacy has largely been assumed. However, a thorough review of the literature reveals that effective teaching strategies, including simulation, in regional anesthesiology and acute pain medicine are not established completely yet. Future research should be directed toward comparative-effectiveness of simulation versus other accepted teaching methods, exploring the combination of procedural training with realistic clinical scenarios, and the application of simulation-based teaching curricula to a wider range of learner, from the student to the practicing physician.

Simulation in teaching regional anesthesia: current perspectives

PubMed Central

Udani, Ankeet D; Kim, T Edward; Howard, Steven K; Mariano, Edward R

2015-01-01

The emerging subspecialty of regional anesthesiology and acute pain medicine represents an opportunity to evaluate critically the current methods of teaching regional anesthesia techniques and the practice of acute pain medicine. To date, there have been a wide variety of simulation applications in this field, and efficacy has largely been assumed. However, a thorough review of the literature reveals that effective teaching strategies, including simulation, in regional anesthesiology and acute pain medicine are not established completely yet. Future research should be directed toward comparative-effectiveness of simulation versus other accepted teaching methods, exploring the combination of procedural training with realistic clinical scenarios, and the application of simulation-based teaching curricula to a wider range of learner, from the student to the practicing physician. PMID:26316812

Use of orally administered carfentanil prior to isoflurane-induced anesthesia in a Kodiak brown bear.

PubMed

Mama, K R; Steffey, E P; Withrow, S J

2000-08-15

A captive 590-kg (1,298-lb) 22-year-old castrated male Kodiak brown bear was evaluated because of a soft tissue mass in the right carpal and antebrachial regions. General anesthesia was deemed necessary on 3 occasions for various procedures including radiographic evaluation and biopsy, excision, and radiation treatment. The bear was given carfentanil orally to induce sedation, followed by i.m. administration of tiletamine-zolazepam (on 1 occasion) and atropine. Anesthesia was maintained by administration of isoflurane in oxygen. After each procedure, effects of carfentanil were reversed by administration of naltrexone. Although there was some variability, blood pressure, nasal temperature, heart rate, respiratory rate, oxygen saturation, PO2, and PCO2 remained within a clinically acceptable ranges.

Cocaine and metabolite concentrations in DBS and venous blood after controlled intravenous cocaine administration

PubMed Central

Ellefsen, Kayla N; da Costa, Jose Luiz; Concheiro, Marta; Anizan, Sebastien; Barnes, Allan J; Pirard, Sandrine; Gorelick, David A; Huestis, Marilyn A

2015-01-01

Background: DBS are an increasingly common clinical matrix. Methods & results: Sensitive and specific methods for DBS and venous blood cocaine and metabolite detection by LC–HRMS and 2D GC–MS, respectively, were validated to examine correlation between concentrations following controlled intravenous cocaine administration. Linear ranges from 1 to 200 µg/l were achieved, with acceptable bias and imprecision. Authentic matched specimens’ (392 DBS, 97 venous blood) cocaine and benzoylecgonine concentrations were qualitatively similar, but DBS had much greater variability (21.4–105.9 %CV) and were lower than in blood. Conclusion: DBS offer advantages for monitoring cocaine intake; however, differences between capillary and venous blood and DBS concentration variability must be addressed. PMID:26327184

Virtual reality in surgical skills training.

PubMed

Palter, Vanessa N; Grantcharov, Teodor P

2010-06-01

With recent concerns regarding patient safety, and legislation regarding resident work hours, it is accepted that a certain amount of surgical skills training will transition to the surgical skills laboratory. Virtual reality offers enormous potential to enhance technical and non-technical skills training outside the operating room. Virtual-reality systems range from basic low-fidelity devices to highly complex virtual environments. These systems can act as training and assessment tools, with the learned skills effectively transferring to an analogous clinical situation. Recent developments include expanding the role of virtual reality to allow for holistic, multidisciplinary team training in simulated operating rooms, and focusing on the role of virtual reality in evidence-based surgical curriculum design. Copyright 2010 Elsevier Inc. All rights reserved.

Designing an activity-based costing model for a non-admitted prisoner healthcare setting.

PubMed

Cai, Xiao; Moore, Elizabeth; McNamara, Martin

2013-09-01

To design and deliver an activity-based costing model within a non-admitted prisoner healthcare setting. Key phases from the NSW Health clinical redesign methodology were utilised: diagnostic, solution design and implementation. The diagnostic phase utilised a range of strategies to identify issues requiring attention in the development of the costing model. The solution design phase conceptualised distinct 'building blocks' of activity and cost based on the speciality of clinicians providing care. These building blocks enabled the classification of activity and comparisons of costs between similar facilities. The implementation phase validated the model. The project generated an activity-based costing model based on actual activity performed, gained acceptability among clinicians and managers, and provided the basis for ongoing efficiency and benchmarking efforts.

Automatic exposure control systems designed to maintain constant image noise: effects on computed tomography dose and noise relative to clinically accepted technique charts.

PubMed

Favazza, Christopher P; Yu, Lifeng; Leng, Shuai; Kofler, James M; McCollough, Cynthia H

2015-01-01

To compare computed tomography dose and noise arising from use of an automatic exposure control (AEC) system designed to maintain constant image noise as patient size varies with clinically accepted technique charts and AEC systems designed to vary image noise. A model was developed to describe tube current modulation as a function of patient thickness. Relative dose and noise values were calculated as patient width varied for AEC settings designed to yield constant or variable noise levels and were compared to empirically derived values used by our clinical practice. Phantom experiments were performed in which tube current was measured as a function of thickness using a constant-noise-based AEC system and the results were compared with clinical technique charts. For 12-, 20-, 28-, 44-, and 50-cm patient widths, the requirement of constant noise across patient size yielded relative doses of 5%, 14%, 38%, 260%, and 549% and relative noises of 435%, 267%, 163%, 61%, and 42%, respectively, as compared with our clinically used technique chart settings at each respective width. Experimental measurements showed that a constant noise-based AEC system yielded 175% relative noise for a 30-cm phantom and 206% relative dose for a 40-cm phantom compared with our clinical technique chart. Automatic exposure control systems that prescribe constant noise as patient size varies can yield excessive noise in small patients and excessive dose in obese patients compared with clinically accepted technique charts. Use of noise-level technique charts and tube current limits can mitigate these effects.

Community Attitudes About Discussing Sexual Health: Assessing Public Opinion of Local STD Prevention Campaigns

PubMed Central

Thomas, Rosalind; Bekan Homawoo, Brigitte; McClamroch, Kristi; Wise, Benjamin; Coles, F. Bruce

2013-01-01

Objectives We assessed public views about the acceptability of and need for sexually transmitted disease (STD) and sexual health-related educational messaging in local campaigns. Methods A 28-item state-added module was included in the 2008 New York Behavioral Risk Factor Surveillance System survey (n=3,751). Respondents rated acceptability of venues/dissemination channels and messaging and agreement with attitudinal/need statements. Additional data were analyzed from a separate state survey with individual county samples (n=36,257). We conducted univariate, bivariate, and multivariable modeling analyses. Results Each venue was acceptable to more than three-quarters of respondents (range: 79% for billboards to 95% for teaching STD prevention in high school). All message areas were acceptable to at least 85% of respondents (acceptability rating range: 85% to 97%). More than 70% agreed that there is a need for more open discussion about STDs. Bivariate analyses identified areas where messaging tailored to specific subgroups may be helpful (e.g., 26% of white people, 44% of African Americans, and 45% of Hispanic people agreed with the statement, “I need ideas about how to talk to my partner about protection from STDs”). Little geographic variation was seen. Results of multivariable modeling on opposition showed limited interaction effects. Conclusion These data provide key information about current community norms and reflect the public's approval for hearing and seeing more about sexual health and STDs in a range of public forums. PMID:23450887

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.

Advance provision of emergency contraception to young men: An exploratory study in a clinic setting.

PubMed

Garbers, Samantha; Bell, D L; Ogaye, K; Marcell, A V; Westhoff, C L; Rosenthal, S L

2018-04-17

To explore the acceptability of advance provision of emergency contraceptive pills (ECPs) to young men seeking health care. For this exploratory study in a clinic setting, we approached young men aged 16-35 to participate in a survey eliciting socio-demographics, sexual and contraceptive history, and knowledge about ECPs. We offered young men advance provision of ECPs and compared characteristics of 126 young men who did and did not accept the ECPs. Most (76%) of the participants accepted advance provision and left with an ECP pack, with even higher proportions among males whose sexual histories were suggestive of increased risk of involvement in an unintended pregnancy. This study holds promise to inform scale up of advance provision of ECPs among young men. Copyright © 2018 Elsevier Inc. All rights reserved.

A Five-Phase Model for Clinical-Outcome Research

ERIC Educational Resources Information Center

Robey, Randall R.

2004-01-01

Through a variety of approaches, speech-language pathologists and audiologists have produced strong evidence that treatments are generally potent. However, we have largely ignored the accepted standards for clinical-outcome testing used throughout the broader research community (e.g., by other clinical disciplines, federal regulators, and…

Brief cognitive and behavioral screening in children with new-onset epilepsy: a pilot feasibility trial.

PubMed

Triplett, Regina L; Asato, Miya R

2015-01-01

Minimal work has used psychometrically robust measures in a systematic fashion to identify and monitor children at risk for cognitive and behavioral comorbidities in current epilepsy care. We piloted a computerized cognitive battery and behavioral questionnaire for children with newly diagnosed epilepsy to determine clinical feasibility and acceptability to parents and patients. We recruited medication-naïve children (ages 8-17 years) with recent-onset seizures and typical developmental history from an outpatient child neurology clinic. Children completed the CNS Vital Signs computerized battery, whereas parents completed the Strengths and Difficulties Questionnaire. Post-test interviews with parents and patients were completed regarding the acceptability of the assessment procedures. Forty-four families were eligible, and 39 agreed to participate (89%). All assessments were completed in less than 45 minutes. Parents rated testing in clinic as convenient and important, expressing strong interest in the cognitive and behavioral impact of epilepsy and medication. Children also rated the testing procedure as acceptable and agreed that they would recommend it to peers. Our brief battery was tolerated and well received by children and their parents. Computerized testing of children along with a parent questionnaire is a psychometrically viable approach that is acceptable to families. Our protocol is time efficient for clinical use with the potential to detect early cognitive and behavioral difficulties related to epilepsy. Ongoing longitudinal study will provide further information regarding the success of our screening methods in monitoring for disease- or treatment-related changes. Copyright © 2015 Elsevier Inc. All rights reserved.

Relationships of consumer sensory ratings, marbling score, and shear force value to consumer acceptance of beef strip loin steaks.

PubMed

Platter, W J; Tatum, J D; Belk, K E; Chapman, P L; Scanga, J A; Smith, G C

2003-11-01

Logistic regression was used to quantify and characterize the effects of changes in marbling score, Warner-Bratzler shear force (WBSF), and consumer panel sensory ratings for tenderness, juiciness, or flavor on the probability of overall consumer acceptance of strip loin steaks from beef carcasses (n = 550). Consumers (n = 489) evaluated steaks for tenderness, juiciness, and flavor using nine-point hedonic scales (1 = like extremely and 9 = dislike extremely) and for overall steak acceptance (satisfied or not satisfied). Predicted acceptance of steaks by consumers was high (> 85%) when the mean consumer sensory rating for tenderness,juiciness, or flavor for a steak was 3 or lower on the hedonic scale. Conversely, predicted consumer acceptance of steaks was low (< or = 10%) when the mean consumer rating for tenderness, juiciness, or flavor for a steak was 5 or higher on the hedonic scale. As mean consumer sensory ratings for tenderness, juiciness, or flavor decreased from 3 to 5, the probability of acceptance of steaks by consumers diminished rapidly in a linear fashion. These results suggest that small changes in consumer sensory ratings for these sensory traits have dramatic effects on the probability of acceptance of steaks by consumers. Marbling score displayed a weak (adjusted R2 = 0.053), yet significant (P < 0.01), relationship to acceptance of steaks by consumers, and the shape of the predicted probability curve for steak acceptance was approximately linear over the entire range of marbling scores (Traces67 to Slightly Abundant97), suggesting that the likelihood of consumer acceptance of steaks increases approximately 10% for each full marbling score increase between Slight to Slightly Abundant. The predicted probability curve for consumer acceptance of steaks was sigmoidal for the WBSF model, with a steep decline in predicted probability of acceptance as WBSF values increased from 3.0 to 5.5 kg. Changes in WBSF within the high (> 5.5 kg) or low (< 3.0 kg) portions of the range of WBSF values had little effect on the probability of consumer acceptance of steaks.

Current clinical use of reteplase for thrombolysis. A pharmacokinetic-pharmacodynamic perspective.

PubMed

Martin, U; Kaufmann, B; Neugebauer, G

1999-04-01

Clinical evaluation of a new thrombolytic agent should start with a dose that provides adequate efficacy and has an acceptably low bleeding risk; this results in a narrow therapeutic window at the upper end of the dose-response curve. Angiographic patency of the infarct-related artery is still the clinical surrogate end-point for mortality in phase II dose-ranging studies. There is experimental and clinical evidence that the area under the concentration-time curve (AUC) for plasminogenolytic activity of a thrombolytic agent is positively correlated with patency of the infarct-related artery. Dose-ranging studies of the novel recombinant plasminogen activator reteplase in healthy volunteers enabled computation of a linear regression curve by which a clinical starting dose could be calculated for an adapted target AUC that would be clinically effective. Pharmacokinetic analysis also revealed that the half-life of reteplase is 4 times longer than that of the reference thrombolytic alteplase, thus allowing bolus injection. The suggested single bolus starting dose of 10U was supported by results from studies in a canine model of coronary thrombolysis. The feedback of insufficiently high patency rates compared with the increased efficacy of front-loaded and accelerated alteplase demanded optimisation strategies for reteplase. Animal experiments suggested that a double bolus regimen of reteplase would be preferable to doubling the single bolus dose. Pharmacokinetic modelling suggested a time interval of 30 min between the 2 bolus injections. Selection of the tested double bolus regimens was conservative and empirical. First, the previously tested single bolus of 15U was divided to 10 + 5U; secondly, the second bolus dose was increased to 10U. This strategy proved to be successful. The current dosage recommendation for reteplase is a double bolus intravenous injection of 10 + 10U, each over 2 min, 30 min apart. This produces a reduction in mortality in patients with acute myocardial infarction that is equivalent to that produced by front-loaded and accelerated infusion of alteplase.