Traditional vs. Simulated Guided Methodology in Teaching Vital Sign Assessment of the Normal Newborn to the Nursing Student: A Clinical Outcome Evaluation

ERIC Educational Resources Information Center

Rivers, Joynelle L.

2012-01-01

Nursing education faces many challenges such as faculty shortages, inadequate clinical site placements, the inability to accept qualified students because of limited resources, and how to effectively educate students who are tech savvy, confident, highly motivated yet have differing needs from previous generations. This study sought to explore how…

Evaluation of a clinical medical librarianship program at a university Health Sciences Library.

PubMed Central

Schnall, J G; Wilson, J W

1976-01-01

An evaluation of the clinical medical librarianship program at the University of Washington Health Sciences Library was undertaken to determine the benefits of the program to patient care and to the education of the recipients of the service. Results of a questionnaire reflected overwhelming acceptance of the clinical medical librarianship program. Guidelines for the establishment of a limited clinical medical librarianship program are described. A statistical cost analysis of the program is included. PMID:938773

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.

Effect of xylitol versus sorbitol: a quantitative systematic review of clinical trials.

PubMed

Mickenautsch, Steffen; Yengopal, Veerasamy

2012-08-01

This study aimed to appraise, within the context of tooth caries, the current clinical evidence and its risk for bias regarding the effects of xylitol in comparison with sorbitol. Databases were searched for clinical trials to 19 March 2011. Inclusion criteria required studies to: test a caries-related primary outcome; compare the effects of xylitol with those of sorbitol; describe a clinical trial with two or more arms, and utilise a prospective study design. Articles were excluded if they did not report computable data or did not follow up test and control groups in the same way. Individual dichotomous and continuous datasets were extracted from accepted articles. Selection and performance/detection bias were assessed. Sensitivity analysis was used to investigate attrition bias. Egger's regression and funnel plotting were used to investigate risk for publication bias. Nine articles were identified. Of these, eight were accepted and one was excluded. Ten continuous and eight dichotomous datasets were extracted. Because of high clinical heterogeneity, no meta-analysis was performed. Most of the datasets favoured xylitol, but this was not consistent. The accepted trials may be limited by selection bias. Results of the sensitivity analysis indicate a high risk for attrition bias. The funnel plot and Egger's regression results suggest a low publication bias risk. External fluoride exposure and stimulated saliva flow may have confounded the measured anticariogenic effect of xylitol. The evidence identified in support of xylitol over sorbitol is contradictory, is at high risk for selection and attrition bias and may be limited by confounder effects. Future high-quality randomised controlled trials are needed to show whether xylitol has a greater anticariogenic effect than sorbitol. © 2012 FDI World Dental Federation.

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

A qualitative study on acceptable levels of risk for pregnant women in clinical research.

PubMed

van der Zande, Indira S E; van der Graaf, Rieke; Oudijk, Martijn A; van Delden, Johannes J M

2017-05-15

There is ambiguity with regard to what counts as an acceptable level of risk in clinical research in pregnant women and there is no input from stakeholders relative to such research risks. The aim of our paper was to explore what stakeholders who are actively involved in the conduct of clinical research in pregnant women deem an acceptable level of risk for pregnant women in clinical research. Accordingly, we used the APOSTEL VI study, a low-risk obstetrical randomised controlled trial, as a case-study. We conducted a prospective qualitative study using 35 in-depth semi-structured interviews and one focus group. We interviewed healthcare professionals, Research Ethics Committee members (RECs) and regulators who are actively involved in the conduct of clinical research in pregnant women, in addition to pregnant women recruited for the APOSTEL VI case-study in the Netherlands. Three themes characterise the way stakeholders view risks in clinical research in pregnant women in general. Additionally, one theme characterises the way healthcare professionals and pregnant women view risks with respect to the case-study specifically. First, ideas on what constitutes an acceptable level of risk in general ranged from a preference for zero risk for the foetus up to minimal risk. Second, the desirability of clinical research in pregnant women in general was questioned altogether. Third, stakeholders proposed to establish an upper limit of risk in potentially beneficial clinical research in pregnant women in order to protect the foetus and the pregnant woman from harm. Fourth and finally, the case-study illustrates that healthcare professionals' individual perception of risk may influence recruitment. Healthcare professionals, RECs, regulators and pregnant women are all risk adverse in practice, possibly explaining the continuing underrepresentation of pregnant women in clinical research. Determining the acceptable levels of risk on a universal level alone is insufficient, because the individual perception of risk also influences behaviour towards pregnant women in clinical research. Therefore, bioethicists and researchers might be interested in changing the perception of risk, which could be achieved by education and awareness about the actual benefits and harms of inclusion and exclusion of pregnant women.

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.

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.

Introducing Scenario Based Learning interactive to postgraduates in UQ Orthodontic Program.

PubMed

Naser-ud-Din, S

2015-08-01

E-learning has gained momentum in health sciences and seems to have great potential in specialist dental education. Higher acceptability by learners is particularly associated with the surge of smart devices. Currently, there are limited number of e-learning modules available for dental education, particularly in Orthodontics. Scenario Based Learning interactive (SBLi(®)) software was used for the first time in Orthodontics Postgraduate training at the University of Queensland. Nine interactive modules were created embedded with clinical procedure videos, web-links, evidence-based literature, along with opportunity for self-assessment and evaluation. Qualitative data were collected before and after the administration of the SBLi(®) for Orthodontics. The purpose of this data was to investigate learning styles and the acceptance of e-modules as part of postgraduate training. Advantages of the package included high acceptance rate, greater confidence in the application of clinical skills covered in the modules and reduced contact time particularly with limited academic staff. E-modules demonstrated high compatibility with the learning styles of the participants and were considered engaging. It seems apparent that e-learning is most effective in a blended learning environment, supplemented with the traditional classroom approach, rather than as a sole mechanism for postgraduate training. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Emollient treatment of atopic dermatitis: latest evidence and clinical considerations

PubMed Central

Kung, Jeng Sum Charmaine; Ng, Wing Gi Gigi; Leung, Ting Fan

2018-01-01

Aim To review current classes of emollients in the market, their clinical efficacy in atopic dermatitis (AD) and considerations for choice of an emollient. Methods PubMed Clinical Queries under Clinical Study Categories (with Category limited to Therapy and Scope limited to Narrow) and Systematic Reviews were used as the search engine. Keywords of ‘emollient or moisturizer’ and ‘atopic dermatitis’ were used. Overview of findings Using the keywords of ‘emollient’ and ‘atopic dermatitis’, there were 105 and 36 hits under Clinical Study Categories (with Category limited to Therapy and Scope limited to Narrow) and Systematic Reviews, respectively. Plant-derived products, animal products and special ingredients were discussed. Selected proprietary products were tabulated. Conclusions A number of proprietary emollients have undergone trials with clinical data available on PubMed-indexed journals. Most moisturizers showed some beneficial effects, but there was generally no evidence that one moisturizer is superior to another. Choosing an appropriate emollient for AD patients would improve acceptability and adherence for emollient treatment. Physician’s recommendation is the primary consideration for patients when selecting a moisturizer/emollient; therefore, doctors should provide evidence-based information about these emollients. PMID:29692852

Feasibility and Acceptability of Adapting the Eating in the Absence of Hunger Assessment for Preschoolers in the Classroom Setting

PubMed Central

Soltero, Erica G.; Ledoux, Tracey; Lee, Rebecca E.

2015-01-01

Eating in the Absence of Hunger (EAH) represents a failure to self-regulate intake leading to overconsumption. Existing research on EAH has come from the clinical setting, limiting our understanding of this behavior. The purpose of this study was to describe the adaptation of the clinical EAH paradigm for preschoolers to the classroom setting and evaluate the feasibility and acceptability of measuring EAH in the classroom. The adapted protocol was implemented in childcare centers in Houston, Texas (N=4) and Phoenix, Arizona (N=2). The protocol was feasible, economical, and time efficient, eliminating previously identified barriers to administering the EAH assessment such as limited resources and the time constraint of delivering the assessment to participants individually. Implementation challenges included difficulty in choosing palatable test snacks that were in compliance with childcare center food regulations and the limited control over the meal that was administered prior to the assessment. The adapted protocol will allow for broader use of the EAH assessment and encourage researchers to incorporate the assessment into longitudinal studies in order to further our understanding of the causes and emergence of EAH. PMID:26172567

Diet and psychological health.

PubMed

Miller, M

1996-09-01

This article reviews research that suggests a relationship between diet and psychological symptoms. Mind-body dualism (as it relates to clinical practice) and the limited role of nutrition in mainstream biomedical training and treatment are discussed as background issues. Two areas of inquiry that have generated relevant research findings in this area are reviewed: (1) orthomolecular theory and vitamin deficiencies, and (2) clinical ecology/environmental medicine theory and the impact of "food allergies." Although clinical case reports and promising research findings have been reported, the impact of diet on psychological health is neither widely accepted nor integrated into mental health treatment methods. Ongoing research findings in brain biochemistry and psychoneuroimmunology point to communication pathways that can provide a clearer understanding of the links between nutritional intake, central nervous system and immune function, and psychological health status. These findings may lead to greater acceptance of dietary treatment approaches among health practitioners addressing psychological disorders.

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.

Robust control of burst suppression for medical coma

NASA Astrophysics Data System (ADS)

Westover, M. Brandon; Kim, Seong-Eun; Ching, ShiNung; Purdon, Patrick L.; Brown, Emery N.

2015-08-01

Objective. Medical coma is an anesthetic-induced state of brain inactivation, manifest in the electroencephalogram by burst suppression. Feedback control can be used to regulate burst suppression, however, previous designs have not been robust. Robust control design is critical under real-world operating conditions, subject to substantial pharmacokinetic and pharmacodynamic parameter uncertainty and unpredictable external disturbances. We sought to develop a robust closed-loop anesthesia delivery (CLAD) system to control medical coma. Approach. We developed a robust CLAD system to control the burst suppression probability (BSP). We developed a novel BSP tracking algorithm based on realistic models of propofol pharmacokinetics and pharmacodynamics. We also developed a practical method for estimating patient-specific pharmacodynamics parameters. Finally, we synthesized a robust proportional integral controller. Using a factorial design spanning patient age, mass, height, and gender, we tested whether the system performed within clinically acceptable limits. Throughout all experiments we subjected the system to disturbances, simulating treatment of refractory status epilepticus in a real-world intensive care unit environment. Main results. In 5400 simulations, CLAD behavior remained within specifications. Transient behavior after a step in target BSP from 0.2 to 0.8 exhibited a rise time (the median (min, max)) of 1.4 [1.1, 1.9] min; settling time, 7.8 [4.2, 9.0] min; and percent overshoot of 9.6 [2.3, 10.8]%. Under steady state conditions the CLAD system exhibited a median error of 0.1 [-0.5, 0.9]%; inaccuracy of 1.8 [0.9, 3.4]%; oscillation index of 1.8 [0.9, 3.4]%; and maximum instantaneous propofol dose of 4.3 [2.1, 10.5] mg kg-1. The maximum hourly propofol dose was 4.3 [2.1, 10.3] mg kg-1 h-1. Performance fell within clinically acceptable limits for all measures. Significance. A CLAD system designed using robust control theory achieves clinically acceptable performance in the presence of realistic unmodeled disturbances and in spite of realistic model uncertainty, while maintaining infusion rates within acceptable safety limits.

Robust control of burst suppression for medical coma

PubMed Central

Westover, M Brandon; Kim, Seong-Eun; Ching, ShiNung; Purdon, Patrick L; Brown, Emery N

2015-01-01

Objective Medical coma is an anesthetic-induced state of brain inactivation, manifest in the electroencephalogram by burst suppression. Feedback control can be used to regulate burst suppression, however, previous designs have not been robust. Robust control design is critical under real-world operating conditions, subject to substantial pharmacokinetic and pharmacodynamic parameter uncertainty and unpredictable external disturbances. We sought to develop a robust closed-loop anesthesia delivery (CLAD) system to control medical coma. Approach We developed a robust CLAD system to control the burst suppression probability (BSP). We developed a novel BSP tracking algorithm based on realistic models of propofol pharmacokinetics and pharmacodynamics. We also developed a practical method for estimating patient-specific pharmacodynamics parameters. Finally, we synthesized a robust proportional integral controller. Using a factorial design spanning patient age, mass, height, and gender, we tested whether the system performed within clinically acceptable limits. Throughout all experiments we subjected the system to disturbances, simulating treatment of refractory status epilepticus in a real-world intensive care unit environment. Main results In 5400 simulations, CLAD behavior remained within specifications. Transient behavior after a step in target BSP from 0.2 to 0.8 exhibited a rise time (the median (min, max)) of 1.4 [1.1, 1.9] min; settling time, 7.8 [4.2, 9.0] min; and percent overshoot of 9.6 [2.3, 10.8]%. Under steady state conditions the CLAD system exhibited a median error of 0.1 [−0.5, 0.9]%; inaccuracy of 1.8 [0.9, 3.4]%; oscillation index of 1.8 [0.9, 3.4]%; and maximum instantaneous propofol dose of 4.3 [2.1, 10.5] mg kg−1. The maximum hourly propofol dose was 4.3 [2.1, 10.3] mg kg−1 h−1. Performance fell within clinically acceptable limits for all measures. Significance A CLAD system designed using robust control theory achieves clinically acceptable performance in the presence of realistic unmodeled disturbances and in spite of realistic model uncertainty, while maintaining infusion rates within acceptable safety limits. PMID:26020243

Implementing human factors in clinical practice.

PubMed

Timmons, Stephen; Baxendale, Bryn; Buttery, Andrew; Miles, Giulia; Roe, Bridget; Browes, Simon

2015-05-01

To understand whether aviation-derived human factors training is acceptable and useful to healthcare professionals. To understand whether and how healthcare professionals have been able to implement human factors approaches to patient safety in their own area of clinical practice. Qualitative, longitudinal study using semi-structured interviews and focus groups, of a multiprofessional group of UK NHS staff (from the emergency department and operating theatres) who have received aviation-derived human factors training. The human factors training was evaluated positively, and thought to be both acceptable and relevant to practice. However, the staff found it harder to implement what they had learned in their own clinical areas, and this was principally attributed to features of the informal organisational cultures. In order to successfully apply human factors approaches in hospital, careful consideration needs to be given to the local context and informal culture of clinical practice. 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.

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.

A survey of physicians' acceptance of telemedicine.

PubMed

Sheng, O R; Hu, P J; Chau, P Y; Hjelm, N M; Tam, K Y; Wei, C P; Tse, J

1998-01-01

Physicians' acceptance of telemedicine is an important managerial issue facing health-care organizations that have adopted, or are about to adopt, telemedicine. Most previous investigations of the acceptance of telemedicine have lacked theoretical foundation and been of limited scope. We examined technology acceptance and usage among physicians and specialists from 49 clinical departments at eight public tertiary hospitals in Hong Kong. Out of the 1021 questionnaires distributed, 310 were completed and returned, a 30% response rate. The preliminary findings suggested that use of telemedicine among clinicians in Hong Kong was moderate. While 18% of the respondents were using some form of telemedicine for patient care and management, it accounted for only 6.3% of the services provided. The intensity of their technology usage was also low, accounting for only 6.8% of a typical telemedicine-assisted service. These preliminary findings have managerial implications.

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.

Glucose determination in human aqueous humor with Raman spectroscopy

NASA Technical Reports Server (NTRS)

Lambert, James L.; Pelletier, Christine C.; Borchert, Mark

2005-01-01

It has been suggested that spectroscopic analysis of the aqueous humor of the eye could be used to indirectly predict blood glucose levels in diabetics noninvasively. We have been investigating this potential using Raman spectroscopy in combination with partial least squares (PLS) analysis. We have determined that glucose at clinically relevant concentrations can be accurately predicted in human aqueous humor in vitro using a PLS model based on artificial aqueous humor. We have further determined that with proper instrument design, the light energy necessary to achieve clinically acceptable prediction of glucose does not damage the retinas of rabbits and can be delivered at powers below internationally acceptable safety limits. Herein we summarize our current results and address our strategies to improve instrument design. 2005 Society of Photo-Optical Instrumentation Engineers.

Cost-effectiveness acceptability curves revisited.

PubMed

Al, Maiwenn J

2013-02-01

Since the introduction of the cost-effectiveness acceptability curve (CEAC) in 1994, its use as a method to describe uncertainty around incremental cost-effectiveness ratios (ICERs) has steadily increased. In this paper, first the construction and interpretation of the CEAC is explained, both in the context of modelling studies and in the context of cost-effectiveness (CE) studies alongside clinical trials. Additionally, this paper reviews the advantages and limitations of the CEAC. Many of the perceived limitations can be attributed to the practice of interpreting the CEAC as a decision rule while it was not developed as such. It is argued that the CEAC is still a useful tool in describing and quantifying uncertainty around the ICER, especially in combination with other tools such as plots on the CE plane and value-of-information analysis.

Magnet-Retained Two-Mini-Implant Overdenture: Clinical and Mechanical Consideration.

PubMed

Ishida, Yuichi; Kumar, H S Kiran; Goto, Takaharu; Watanabe, Megumi; Wigianto, Rudi; Ichikawa, Tetsuo

2016-10-10

Two-implant overdentures have become the accepted treatment for restoring mandibular edentulism. The dimensions of regular implants sometimes limit their use, such as in the case of narrow ridges. Mini-implants with reduced diameters (less than 3.0 mm) enable insertion into narrow ridges. A magnet-retained two-mini-implant overdenture system was developed and is described in this paper. Additionally, we describe a clinical mandibular procedure using the system and evaluate its biomechanical performance.

Magnet-Retained Two-Mini-Implant Overdenture: Clinical and Mechanical Consideration

PubMed Central

Ishida, Yuichi; Kumar, H. S. Kiran; Goto, Takaharu; Watanabe, Megumi; Wigianto, Rudi; Ichikawa, Tetsuo

2016-01-01

Two-implant overdentures have become the accepted treatment for restoring mandibular edentulism. The dimensions of regular implants sometimes limit their use, such as in the case of narrow ridges. Mini-implants with reduced diameters (less than 3.0 mm) enable insertion into narrow ridges. A magnet-retained two-mini-implant overdenture system was developed and is described in this paper. Additionally, we describe a clinical mandibular procedure using the system and evaluate its biomechanical performance. PMID:29563477

Factors Likely to Affect Community Acceptance of a Malaria Vaccine in Two Districts of Ghana: A Qualitative Study

PubMed Central

Meñaca, Arantza; Tagbor, Harry; Adjei, Rose; Bart-Plange, Constance; Collymore, Yvette; Ba-Nguz, Antoinette; Mertes, Kelsey; Bingham, Allison

2014-01-01

Malaria is a leading cause of morbidity and mortality among children in Ghana. As part of the effort to inform local and national decision-making in preparation for possible malaria vaccine introduction, this qualitative study explored community-level factors that could affect vaccine acceptance in Ghana and provides recommendations for a health communications strategy. The study was conducted in two purposively selected districts: the Ashanti and Upper East Regions. A total of 25 focus group discussions, 107 in-depth interviews, and 21 semi-structured observations at Child Welfare Clinics were conducted. Malaria was acknowledged to be one of the most common health problems among children. While mosquitoes were linked to the cause and bed nets were considered to be the main preventive method, participants acknowledged that no single measure prevented malaria. The communities highly valued vaccines and cited vaccination as the main motivation for taking children to Child Welfare Clinics. Nevertheless, knowledge of specific vaccines and what they do was limited. While communities accepted the idea of minor vaccine side effects, other side effects perceived to be more serious could deter families from taking children for vaccination, especially during vaccination campaigns. Attendance at Child Welfare Clinics after age nine months was limited. Observations at clinics revealed that while two different opportunities for counseling were offered, little attention was given to addressing mothers’ specific concerns and to answering questions related to child immunization. Positive community attitudes toward vaccines and the understanding that malaria prevention requires a comprehensive approach would support the introduction of a malaria vaccine. These attitudes are bolstered by a well-established child welfare program and the availability in Ghana of active, flexible structures for conveying health information to communities. At the same time, it would be important to improve the quality of Child Welfare Clinic services, particularly in relation to communication around vaccination. PMID:25334094

Factors likely to affect community acceptance of a malaria vaccine in two districts of Ghana: a qualitative study.

PubMed

Meñaca, Arantza; Tagbor, Harry; Adjei, Rose; Bart-Plange, Constance; Collymore, Yvette; Ba-Nguz, Antoinette; Mertes, Kelsey; Bingham, Allison

2014-01-01

Malaria is a leading cause of morbidity and mortality among children in Ghana. As part of the effort to inform local and national decision-making in preparation for possible malaria vaccine introduction, this qualitative study explored community-level factors that could affect vaccine acceptance in Ghana and provides recommendations for a health communications strategy. The study was conducted in two purposively selected districts: the Ashanti and Upper East Regions. A total of 25 focus group discussions, 107 in-depth interviews, and 21 semi-structured observations at Child Welfare Clinics were conducted. Malaria was acknowledged to be one of the most common health problems among children. While mosquitoes were linked to the cause and bed nets were considered to be the main preventive method, participants acknowledged that no single measure prevented malaria. The communities highly valued vaccines and cited vaccination as the main motivation for taking children to Child Welfare Clinics. Nevertheless, knowledge of specific vaccines and what they do was limited. While communities accepted the idea of minor vaccine side effects, other side effects perceived to be more serious could deter families from taking children for vaccination, especially during vaccination campaigns. Attendance at Child Welfare Clinics after age nine months was limited. Observations at clinics revealed that while two different opportunities for counseling were offered, little attention was given to addressing mothers' specific concerns and to answering questions related to child immunization. Positive community attitudes toward vaccines and the understanding that malaria prevention requires a comprehensive approach would support the introduction of a malaria vaccine. These attitudes are bolstered by a well-established child welfare program and the availability in Ghana of active, flexible structures for conveying health information to communities. At the same time, it would be important to improve the quality of Child Welfare Clinic services, particularly in relation to communication around vaccination.

Handheld Technology Acceptance in Radiologic Science Education and Training Programs

ERIC Educational Resources Information Center

Powers, Kevin Jay

2012-01-01

The purpose of this study was to explore the behavioral intention of directors of educational programs in the radiologic sciences to adopt handheld devices to aid in managing student clinical data. Handheld devices were described to participants as a technology representing a class of mobile electronic devices including, but not limited to,…

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.

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.

Modified Directly Observed Therapy to Facilitate Highly Active Antiretroviral Therapy Adherence in Beira, Mozambique

PubMed Central

Pearson, Cynthia R.; Micek, Mark; Simoni, Jane M.; Matediana, Eduardo; Martin, Diane P.; Gloyd, Stephen

2016-01-01

Summary As resource-limited countries expand access to highly active antiretroviral therapy (HAART) treatment, innovative programs are needed to support adherence in the context of significant health system barriers. Modified directly observed therapy (mDOT) is one such strategy, but little is known about the process of designing and implementing mDOT programs for HAART in resource-limited settings. In this descriptive study, we used a mixed-methods approach to describe the process of implementing mDOT for an ongoing randomized control trial (RCT) in Beira, Mozambique. Interviews with clinic staff, mDOT peers, and participants provided information on design elements, problems with implementation, satisfaction, and benefits. Acceptability and feasibility measures were obtained from the RCT. Most (81%, N = 350) eligible persons agreed to participate, and of those randomized to mDOT (n = 174), 95% reported that their time with peers was beneficial. On average, participants kept 93% of the 30 required daily mDOT visits. Key components of the intervention’s success included using peers who were well accepted by clinic staff, adequate training and retention of peers, adapting daily visit requirements to participants’ work schedules and physical conditions, and reimbursing costs of transportation. This study identified aspects of mDOT that are effective and can be adopted by other clinics treating HIV patients. PMID:17133197

Imaging study of using radiopharmaceuticals labeled with cyclotron-produced 99mTc.

PubMed

Hou, X; Tanguay, J; Vuckovic, M; Buckley, K; Schaffer, P; Bénard, F; Ruth, T J; Celler, A

2016-12-07

Cyclotron-produced 99m Tc (CPTc) has been recognized as an attractive and practical substitution of reactor/generator based 99m Tc. However, the small amount of 92-98 Mo in the irradiation of enriched 100 Mo could lead to the production of other radioactive technetium isotopes (Tc-impurities) which cannot be chemically separated. Thus, these impurities could contribute to patient dose and affect image quality. The potential radiation dose caused by these Tc-impurities produced using different targets, irradiation conditions, and corresponding to different injection times have been investigated, leading us to create dose-based limits of these parameters for producing clinically acceptable CPTc. However, image quality has been not considered. The aim of the present work is to provide a comprehensive and quantitative analysis of image quality for CPTc. The impact of Tc-impurities in CPTc on image resolution, background noise, and contrast is investigated by performing both Monte-Carlo simulations and phantom experiments. Various targets, irradiation, and acquisition conditions are employed for investigating the image-based limits of CPTc production parameters. Additionally, the relationship between patient dose and image quality of CPTc samples is studied. Only those samples which meet both dose- and image-based limits should be accepted in future clinical studies.

Imaging study of using radiopharmaceuticals labeled with cyclotron-produced 99mTc

NASA Astrophysics Data System (ADS)

Hou, X.; Tanguay, J.; Vuckovic, M.; Buckley, K.; Schaffer, P.; Bénard, F.; Ruth, T. J.; Celler, A.

2016-12-01

Cyclotron-produced 99mTc (CPTc) has been recognized as an attractive and practical substitution of reactor/generator based 99mTc. However, the small amount of 92-98Mo in the irradiation of enriched 100Mo could lead to the production of other radioactive technetium isotopes (Tc-impurities) which cannot be chemically separated. Thus, these impurities could contribute to patient dose and affect image quality. The potential radiation dose caused by these Tc-impurities produced using different targets, irradiation conditions, and corresponding to different injection times have been investigated, leading us to create dose-based limits of these parameters for producing clinically acceptable CPTc. However, image quality has been not considered. The aim of the present work is to provide a comprehensive and quantitative analysis of image quality for CPTc. The impact of Tc-impurities in CPTc on image resolution, background noise, and contrast is investigated by performing both Monte-Carlo simulations and phantom experiments. Various targets, irradiation, and acquisition conditions are employed for investigating the image-based limits of CPTc production parameters. Additionally, the relationship between patient dose and image quality of CPTc samples is studied. Only those samples which meet both dose- and image-based limits should be accepted in future clinical studies.

A pragmatic guide on how physicians can take over financial control of their clinical practice.

PubMed

Jacobs, Volker R; Fischer, Thorsten

2012-01-01

Control of clinical cost is becoming increasingly important in health care worldwide. Physicians should accept the limitation of resources and take responsibility to improve their clinical cost-reimbursement ratio. To achieve this, they will need basic education in clinic management to control and adjust costs and reimbursement, without impacting professional quality of care. Rational use of diagnostics and therapy should be implemented and frequently verified. Physicians are the only professionals that are able to integrate economics with health care. This is in the best interest of patients and will improve a physician's position, influence, and professional freedom levels within our hospitals.

Clinical acceptability of metal-ceramic fixed partial dental prosthesis fabricated with direct metal laser sintering technique-5 year follow-up

PubMed Central

Prabhu, Radhakrishnan; Prabhu, Geetha; Baskaran, Eswaran; Arumugam, Eswaran M.

2016-01-01

Statement of Problem: 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. Aims and Objective: 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. Materials and Methods: 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. Results: 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. Conclusion: DMLS metal-ceramic fixed partial denture prosthesis had a survival rate of 95.5% and yielded promising results during the 5-year clinical study. PMID:27141171

A screening tool to enhance clinical trial participation at a community center involved in a radiation oncology disparities program.

PubMed

Proctor, Julian W; Martz, Elaine; Schenken, Larry L; Rainville, Rebecca; Marlowe, Ursula

2011-05-01

To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute-funded disparities program but lacking on-site clinical trials personnel. The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services. Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%). When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials.

A Screening Tool to Enhance Clinical Trial Participation at a Community Center Involved in a Radiation Oncology Disparities Program

PubMed Central

Proctor, Julian W.; Martz, Elaine; Schenken, Larry L.; Rainville, Rebecca; Marlowe, Ursula

2011-01-01

Purpose: To investigate the effectiveness of a screening tool to enhance clinical trial participation at a community radiation oncology center involved in a National Cancer Institute–funded disparities program but lacking on-site clinical trials personnel. Patients and Methods: The screening form was pasted to the front of the charts and filled out for all new patients over the 9-month period of the study, during which time five external beam radiation therapy (EBRT) trials and a patient perception study were open for accrual. Patient consent was obtained by assorted personnel at several different sites. Patients potentially eligible for a trial were identified and approached by one of the clinic staff. Patients who were under- or uninsured, age > 80 years, members of an racial/ethnic minority, or recipients of medical assistance were identified as at risk for health care disparities and were offered patient navigator services. Results: Of 196 patients consulted during the study, 144 were treated with EBRT. Of the 24 patients eligible for EBRT trials, 23 were approached (one had an incomplete screening form), and 15 accepted. Of 77 patients eligible for a patient perception trial, 72 were approached (five had incomplete forms), and 45 accepted. The eligibility and acceptance rates for EBRT trials were similar for disparities and nondisparities patients. Screening was completed for 96 patients (67%). Conclusion: When completed, the screening tool ensured clinical trial accrual. The major factor limiting overall accrual was a shortage of available trials. PMID:21886496

Training Addiction Counselors to Implement an Evidence-Based Intervention: Strategies for Increasing Organizational and Provider Acceptance

ERIC Educational Resources Information Center

Woo, Stephanie M.; Hepner, Kimberly A.; Gilbert, Elizabeth A.; Osilla, Karen Chan; Hunter, Sarah B.; Munoz, Ricardo F.; Watkins, Katherine E.

2013-01-01

One barrier to widespread public access to empirically supported treatments (ESTs) is the limited availability and high cost of professionals trained to deliver them. Our earlier work from 2 clinical trials demonstrated that front-line addiction counselors could be trained to deliver a manualized, group-based cognitive behavioral therapy (GCBT)…

76 FR 51375 - Dialogues in Diversifying Clinical Trials: Successful Strategies for Engaging Women and...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-08-18

...: Registration is free, but seating is limited to 200. Registration will be accepted online and is available at... Griffith, Society for Women's Health Research (SWHR), 1025 Connecticut Ave., NW., Suite 701, Washington, DC... to a disability, please contact Rachel Griffith at least 7 days in advance. Dated: August 12, 2011...

Computer-Assisted Analysis of Spontaneous Speech: Quantification of Basic Parameters in Aphasic and Unimpaired Language

ERIC Educational Resources Information Center

Hussmann, Katja; Grande, Marion; Meffert, Elisabeth; Christoph, Swetlana; Piefke, Martina; Willmes, Klaus; Huber, Walter

2012-01-01

Although generally accepted as an important part of aphasia assessment, detailed analysis of spontaneous speech is rarely carried out in clinical practice mostly due to time limitations. The Aachener Sprachanalyse (ASPA; Aachen Speech Analysis) is a computer-assisted method for the quantitative analysis of German spontaneous speech that allows for…

Medical innovation versus stem cell tourism.

PubMed

Lindvall, Olle; Hyun, Insoo

2009-06-26

Stem cell tourism is criticized on grounds of consumer fraud, blatant lack of scientific justification, and patient safety. However, the issues are complex because they invoke questions concerning the limits of acceptable medical innovation and medical travel. Here we discuss these issues and articulate conditions under which "unproven" therapies may be offered to patients outside of regular clinical trials.

Thermoluminescent dosimeters (TLD) quality assurance network in the Czech Republic.

PubMed

Kroutilķková, Daniela; Novotný, Josef; Judas, Libor

2003-02-01

The Czech thermoluminescent dosimeters (TLD) quality assurance network was established in 1997. Its aim is to pursue a regular independent quality audit in Czech radiotherapy centres and to support state supervision. The audit is realised via mailed TL dosimetry. The TLD system consists of encapsulated LiF:Mg,Ti powder (type MT-N) read with Harshaw manual reader model 4000. Basic mode of the TLD audit covers measurements under reference conditions, specifically beam calibration checks for all clinically used photon and electron beams. Advanced mode consists of measurements under both reference and non-reference conditions using a solid multipurpose phantom ('Leuven phantom') for photon beams. The radiotherapy centres are instructed to deliver to the TLD on central beam axis absorbed dose of 2 Gy calculated with their treatment planning system for a particular treatment set-up. The TLD measured doses are compared with the calculated ones. Deviations of +/-3% are considered acceptable for both basic and advanced mode of the audit. There are 34 radiotherapy centres in the Czech Republic. They undergo the basic mode of the TLD audit regularly every 2 years. If a centre shows a deviation outside the acceptance level, it is audited more often. Presently, most of the checked beams comply with the acceptance level. The advanced TLD audit has been implemented as a pilot study for the present. The results were mostly within the acceptance limit for the measurements on-axis, whereas for off-axis points they fell beyond the limit more frequently, especially for set-ups with inhomogeneities, oblique incidence and wedges. The results prove the importance of the national TLD quality assurance network. It has contributed to the improvement of clinical dosimetry in the Czech Republic. In addition, it helps the regulatory authority to monitor effectively and regularly radiotherapy centres.

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.

Using theories of learning in workplaces to enhance physiotherapy clinical education.

PubMed

Patton, Narelle; Higgs, Joy; Smith, Megan

2013-10-01

Clinical education has long been accepted as integral to the education of physiotherapy students and their preparation for professional practice. The clinical environment, through practice immersion, situates students in a powerful learning context and plays a critical role in students' construction of professional knowledge. Despite this acknowledged centrality of practice and clinical environments to the students' experiential construction of professional knowledge, there has been limited exploration of learning theories underpinning clinical education in the literature. In this paper, we explore a selection of learning theories underpinning physiotherapy clinical education with a view to providing clinical educators with a firm foundation on which to base wise educational practices and potentially enhance physiotherapy students' clinical learning experiences. This exploration has drawn from leading thinkers in the field of education over the past century.

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.

Automatic Exposure Control Systems Designed to Maintain Constant Image Noise: Effects on Computed Tomography Dose and Noise Relative to Clinically Accepted Technique Charts

PubMed Central

Favazza, Christopher P.; Yu, Lifeng; Leng, Shuai; Kofler, James M.; McCollough, Cynthia H.

2015-01-01

Objective 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. Materials and Methods 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. Results 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. Conclusions 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. PMID:25938214

Electrical safety Q&A. A reference guide for the clinical engineer.

PubMed

2005-02-01

This guide, which ECRI developed to answer the electrical safety questions most frequently asked by member hospitals, features practical advice for addressing electrical safety concerns in the healthcare environment. Questions addressed include: STANDARDS AND APPROVALS: What electrical safety standards apply? How do NFPA 99 and IEC 60601-1 differ? What organizations approve medical devices? LEAKAGE CURRENT LIMITS AND TESTING: How are leakage current limits established? What limits apply to equipment used in the hospital? And how should the limits be applied in special cases, such as the use of PCs in the patient care area or equipment used in the clinical laboratory? ISOLATED POWER: What are its advantages and disadvantages, and is isolated power needed in the operating room? Other topics addressed include double insulation, ground-fault circuit interrupters (GFCIs), and requirements for medical devices used in the home. Supplementary articles discuss acceptable alternatives to UL listing, the use of Hospital Grade plugs, the limitations of leakage current testing of devices connected to isolated power systems, and the debate about whether to designate ORs as wet locations. Experienced clinical engineers should find this guide to be a handy reference, while those new to the field should find it to be a helpful educational resource.

National Decline in Donor Heart Utilization With Regional Variability: 1995–2010

PubMed Central

Khush, K. K.; Zaroff, J. G.; Nguyen, J.; Menza, R.; Goldstein, B. A.

2015-01-01

The severe shortage of donor hearts limits the availability of transplantation for the growing population of patients with end-stage heart disease. We examined national trends in donor heart acceptance for transplant. OPTN data were analyzed for all potential adult cardiac organ donors between 1995 and 2010. Donor heart disposition was categorized as transplanted, declined for transplant or other. We studied changes in the probability of donor heart acceptance according to demographic and clinical characteristics, nationwide and by UNOS region. Of 82 053 potential donor hearts, 34% were accepted and 48% were declined (18% used for other purposes). There was a significant decrease in donor heart acceptance from 44% in 1995 to 29% in 2006, and subsequent increase to 32% in 2010. Older donor age, female sex and medical co-morbidities predicted non-acceptance. Donor age and co-morbidities increased during the study period, with a concomitant decrease in acceptance of hearts from donors with undesirable characteristics. Overall, predictors of heart non-use were similar across UNOS regions, although utilization varied between regions. Regional variation suggests a potential to improve heart acceptance rates in under-performing regions, and supports research and policy efforts aimed at establishing evidence-based criteria for donor heart evaluation and acceptance for transplantation. PMID:25676093

Challenges in international medicine: ethical dilemmas, unanticipated consequences, and accepting limitations.

PubMed

Iserson, Kenneth V; Biros, Michelle H; James Holliman, C

2012-06-01

While personal and organizational challenges occur in every area of health care, practitioners of international medicine face unique problems and dilemmas that are rarely discussed in training programs. Health professions schools, residency and fellowship programs, nongovernmental organizations (NGOs), and government programs have a responsibility to make those new to international medicine aware of the special circumstances that they may face and to provide methods for understanding and dealing with these circumstances. Standard "domestic" approaches to such challenges may not work in international medicine, even though these challenges may appear to be similar to those faced in other clinical settings. How should organizations ensure that well-meaning health intervention efforts do not cause adverse unintended sequelae? How should an individual balance respect for cultural uniqueness and local mores that may profoundly differ from his or her own beliefs, with the need to remain a moral agent true to one's self? When is acceptance the appropriate response to situations in which limitations of resources seem to preclude any good solution? Using a case-based approach, the authors discuss issues related to the four major international medicine domains: clinical practice (postdisaster response, resource limitations, standards of care), medical systems and systems development (prehospital care, wartime casualties, sustainable change, cultural awareness), teaching (instruction and local resources, professional preparation), and research (questionable funded studies, clinical trials, observational studies). It is hoped that this overview may help prepare those involved with international medicine for the challenges and dilemmas they may face and help frame their responses to these situations. © 2012 by the Society for Academic Emergency Medicine.

Psychometric properties of the Portuguese version of the Acceptance and Action Questionnaire-Trauma Specific (AAQ-TS): A study with Portuguese Colonial War Veterans.

PubMed

Pinto-Gouveia, José; Carvalho, Teresa; Cunha, Marina; Duarte, Joana; Walser, Robyn D

2015-10-01

The Acceptance and Action Questionnaire-Trauma Specific (AAQ-TS) is a self-report measure designed to assess-trauma-related psychological (in)flexibility, as conceptualized in Acceptance and Commitment Therapy. However, there are no studies to date regarding its psychometric properties. This study explores such properties in the Portuguese version of the AAQ-TS, in Portuguese Colonial War Veterans. A Principal Components Analysis (PCA) was conducted in a sample from the general population of war Veterans (N=371). Confirmatory Factor Analysis (CFA) as well as reliability and convergent validity studies were performed in a different sample from the same population (N=312). For the discriminant validity a clinical sample with a war-related PTSD (N=42) and a non-clinical sample without PTSD (N=44) were used. The CFA suggested a re-specified 15-item model with good global adjustment and factorial validity. The AAQ-TS showed internal consistency, a good temporal reliability, convergent validity with psychopathological symptoms (related to PTSD, anxiety, depression and stress) and peritraumatic dissociation (altered awareness and depersonalization/derealization). The questionnaire also discriminates between war Veterans with and without a PTSD diagnosis. The major limitation relates to the samples' characteristics and sampling methods, which can limit the generalization of results. The Portuguese version of the AAQ-TS is a reliable and valid measure to assess experiential avoidance related to trauma in Portuguese Colonial War Veterans. Copyright © 2015 Elsevier B.V. All rights reserved.

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.

Cardiac output monitoring using indicator-dilution techniques: basics, limits, and perspectives.

PubMed

Reuter, Daniel A; Huang, Cecil; Edrich, Thomas; Shernan, Stanton K; Eltzschig, Holger K

2010-03-01

The ability to monitor cardiac output is one of the important cornerstones of hemodynamic assessment for managing critically ill patients at increased risk for developing cardiac complications, and in particular in patients with preexisting cardiovascular comorbidities. For >30 years, single-bolus thermodilution measurement through a pulmonary artery catheter for assessment of cardiac output has been widely accepted as the "clinical standard" for advanced hemodynamic monitoring. In this article, we review this clinical standard, along with current alternatives also based on the indicator-dilution technique, such as the transcardiopulmonary thermodilution and lithium dilution techniques. In this review, not only the underlying technical principles and the unique features but also the limitations of each application of indicator dilution are outlined.

Tablet computers in assessing performance in a high stakes exam: opinion matters.

PubMed

Currie, G P; Sinha, S; Thomson, F; Cleland, J; Denison, A R

2017-06-01

Background Tablet computers have emerged as a tool to capture, process and store data in examinations, yet evidence relating to their acceptability and usefulness in assessment is limited. Methods We performed an observational study to explore opinions and attitudes relating to tablet computer use in recording performance in a final year objective structured clinical examination at a single UK medical school. Examiners completed a short questionnaire encompassing background, forced-choice and open questions. Forced choice questions were analysed using descriptive statistics and open questions by framework analysis. Results Ninety-two (97% response rate) examiners completed the questionnaire of whom 85% had previous use of tablet computers. Ninety per cent felt checklist mark allocation was 'very/quite easy', while approximately half considered recording 'free-type' comments was 'easy/very easy'. Greater overall efficiency of marking and resource savings were considered the main advantages of tablet computers, while concerns relating to technological failure and ability to record free type comments were raised. Discussion In a context where examiners were familiar with tablet computers, they were preferred to paper checklists, although concerns were raised. This study adds to the limited literature underpinning the use of electronic devices as acceptable tools in objective structured clinical examinations.

Radiochemical purity of iodine-131 labelled metaiodobenzylguanidine infusion fluids: a report from clinical practice.

PubMed

Wafelman, A R; Suchi, R; Hoefnagel, C A; Beijnen, J H

1993-07-01

Iodine-131 labelled metaiodobenzylguanidine ([131I]MIBG) has a diagnostic and therapeutic role in the management of neural crest tumours, particularly neuroblastoma, malignant phaeochromocytoma and paraganglioma. With therapeutic amounts of [131I]MIBG it is essential that the amount of free [131I]iodide, the most important impurity, is known. In clinical practice the percentage of free [131I]iodide seen in a [131I]MIBG infusion concentrate increased from 2.2% +/- 0.67% to 3.6% +/- 0.39% (mean +/- SD; n = 23) 1 day after production. At the time of use the percentage of free [131I]iodide was always below our upper limit of acceptance of 5%. Since 5% of free [131I]iodide is within practical reach in our environment, a higher percentage at the time of preadministration quality control is not accepted in the Netherlands Cancer Institute.

Perceptions and attitudes toward clinical trials in adolescent and young adults with cancer: a systematic review.

PubMed

Forcina, Victoria; Vakeesan, Branavan; Paulo, Chelsea; Mitchell, Laura; Bell, Jennifer Ah; Tam, Seline; Wang, Kate; Gupta, Abha A; Lewin, Jeremy

2018-01-01

Although cancer clinical trials (CT) offer opportunities for novel treatments that may lead to improved outcomes, adolescents and young adults (AYA) are less likely to participate in these trials as compared to younger children and older adults. We aimed to identify the perceptions and attitudes toward CT in AYA that influence trial participation. A systematic review of cancer literature was conducted that assessed perceptions and attitudes toward CT enrollment limited to AYA patients (defined as age 15-39). We estimated the frequency of identified themes by pooling identified studies. In total, six original research articles were identified that specifically addressed perceptions or attitudes that influenced CT participation in AYA patients. Three studies were conducted at pediatric centers - one at an AYA unit, one at an adult cancer hospital, and one was registry based. Major themes identified for CT acceptability included: hope for positive clinical affect, altruism, and having autonomy. Potential deterrents included: prolonged hospitalization, worry of side effects, and discomfort with experimentation. Limited information is available with regard to the perceptions and attitudes toward CT acceptability among AYA patients, especially those treated at adult cancer centers, which prevents generalization of data and themes. Future research assessing strategies for understanding and supporting CT decision-making processes among AYA represents a key focus for future funding to improve CT enrollment.

An innovative approach to near-infrared spectroscopy using a standard mobile device and its clinical application in the real-time visualization of peripheral veins.

PubMed

Juric, Simon; Zalik, Borut

2014-11-25

Excessive venipunctures are a significant problem both in emergency rooms and during hospital stays. Near-infrared (NIR) illumination devices improve venipuncture success rate but their usage is limited by their availability and economic cost. The objectives of this study were to develop a low-cost NIR spectroscopy prototype from a standard mobile device, to evaluate its efficacy and acceptance as an educational tool, and in a clinical setting. Through a user-centric design process a prototype device was developed. Its educational efficacy was evaluated through a non-invasive, observational study (20 student clinicians, 25 subjects) and its acceptance was assessed using quantitative and qualitative analysis. A smaller clinical trial was performed by a group of 4 medical professionals over a period of 6 weeks that involved 64 patients. The prototype enables real-time visualization of peripheral veins on a variety of Android-based devices. The prototype was 35.2% more successful in visualizing and locating veins (n = 500 attempts) than the nursing students. The acceptance assessment revealed high perception of usefulness, satisfaction, and ease of use. In the clinical trial, 1.6 (SD 1.3) additional veins per patient were identified compared with the traditional visualization methods. To the best of our knowledge this is the first study that describes the design, feasibility and application of an NIR spectroscopy prototype developed on a standard mobile device.

Development of a Weight Loss Mobile App Linked With an Accelerometer for Use in the Clinic: Usability, Acceptability, and Early Testing of its Impact on the Patient-Doctor Relationship.

PubMed

Choo, Seryung; Kim, Ju Young; Jung, Se Young; Kim, Sarah; Kim, Jeong Eun; Han, Jong Soo; Kim, Sohye; Kim, Jeong Hyun; Kim, Jeehye; Kim, Yongseok; Kim, Dongouk; Steinhubl, Steve

2016-03-31

Although complications of obesity are well acknowledged and managed by clinicians, management of obesity itself is often difficult, which leads to its underdiagnosis and undertreatment in hospital settings. However, tools that could improve the management of obesity, including self-monitoring, engagement with a social network, and open channels of communication between the patient and doctor, are limited in a clinic-based setting. The objective of our study was to evaluate the usability and acceptability of a newly developed mobile app linked with an accelerometer and its early effects on patient-doctor relationships. From September 2013 to February 2014, we developed a mobile app linked with an accelerometer as a supportive tool for a clinic-based weight loss program. The app used information from electronic health records and delivered tailored educational material. Personal goal setting, as well as monitoring of weight changes and physical activity combined with feedback, are key features of the app. We also incorporated an interactive message board for patients and doctors. During the period of March 2014 to May 2014, we tested our mobile app for 1 month in participants in a hospital clinic setting. We assessed the app's usability and acceptability, as well as the patient-doctor relationship, via questionnaires and analysis of app usage data. We recruited 30 individuals (18 male and 12 female) for the study. The median number of log-ins per day was 1.21, with the most frequently requested item being setting goals, followed by track physical activities and view personal health status. Scales of the depth of the patient-doctor relationship decreased from 27.6 (SD 4.8) to 25.1 (SD 4.5) by a Wilcoxon signed rank test (P=.02). A mobile phone app linked with an accelerometer for a clinic-based weight loss program is useful and acceptable for weight management but exhibited less favorable early effects on patient-doctor relationships.

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.

Effective Clinical Supervision in Substance Use Disorder Treatment Programs and Counselor Job Performance.

PubMed

Rothrauff-Laschober, Tanja C; Eby, Lillian Turner de Tormes; Sauer, Julia B

2013-01-01

When mental health counselors have limited and/or inadequate training in substance use disorders (SUDs), effective clinical supervision (ECS) may advance their professional development. The purpose of the current study was to investigate whether ECS is related to the job performance of SUD counselors. Data were obtained in person via paper-and-pencil surveys from 392 matched SUD counselor-clinical supervisor dyads working in 27 SUD treatment organizations across the United States. ECS was rated by counselors and measured with five multi-item scales (i.e., sponsoring counselors' careers, providing challenging assignments, role modeling, accepting/confirming counselors' competence, overall supervisor task proficiency). Clinical supervisors rated counselors' job performance, which was measured with two multi-item scales (i.e., task performance, performance within supervisory relationship). Using mixed-effects models, we found that most aspects of ECS are related to SUD counselor job performance. Thus, ECS may indeed enhance counselors' task performance and performance within the supervisory relationship, and, as a consequence, offset limited formal SUD training.

Effective Clinical Supervision in Substance Use Disorder Treatment Programs and Counselor Job Performance

PubMed Central

2013-01-01

When mental health counselors have limited and/or inadequate training in substance use disorders (SUDs), effective clinical supervision (ECS) may advance their professional development. The purpose of the current study was to investigate whether ECS is related to the job performance of SUD counselors. Data were obtained in person via paper-and-pencil surveys from 392 matched SUD counselor-clinical supervisor dyads working in 27 SUD treatment organizations across the United States. ECS was rated by counselors and measured with five multi-item scales (i.e., sponsoring counselors’ careers, providing challenging assignments, role modeling, accepting/confirming counselors’ competence, overall supervisor task proficiency). Clinical supervisors rated counselors’ job performance, which was measured with two multi-item scales (i.e., task performance, performance within supervisory relationship). Using mixed-effects models, we found that most aspects of ECS are related to SUD counselor job performance. Thus, ECS may indeed enhance counselors’ task performance and performance within the supervisory relationship, and, as a consequence, offset limited formal SUD training. PMID:25061265

Regulatory Acceptance of Alternative Methods in the Development and Approval of Pharmaceuticals.

PubMed

Beken, Sonja; Kasper, Peter; van der Laan, Jan-Willem

Animal studies may be carried out to support first administration of a new medicinal product to either humans or the target animal species, or before performing clinical trials in even larger populations, or before marketing authorisation, or to control quality during production. Ethical and animal welfare considerations require that animal use is limited as much as possible. Directive 2010/63/EU on the protection of animals used for scientific purposes unambiguously fosters the application of the principle of the 3Rs when considering the choice of methods to be used.As such, today, the 3Rs are embedded in the relevant regulatory guidance both at the European (European Medicines Agency (EMA)) and (Veterinary) International Conference on Harmonization ((V)ICH) levels. With respect to non-clinical testing requirements for human medicinal products, reduction and replacement of animal testing has been achieved by the regulatory acceptance of new in vitro methods, either as pivotal, supportive or exploratory mechanistic studies. Whilst replacement of animal studies remains the ultimate goal, approaches aimed at reducing or refining animal studies have also been routinely implemented in regulatory guidelines, where applicable. The chapter provides an overview of the implementation of 3Rs in the drafting of non-clinical testing guidelines for human medicinal products at the level of the ICH. In addition, the revision of the ICH S2 guideline on genotoxicity testing and data interpretation for pharmaceuticals intended for human use is discussed as a case study.In October 2010, the EMA established a Joint ad hoc Expert Group (JEG 3Rs) with the mandate to improve and foster the application of 3Rs principles to the regulatory testing of medicinal products throughout their lifecycle. As such, a Guideline on regulatory acceptance of 3R testing approaches was drafted that defines regulatory acceptance and provides guidance on the scientific and technical criteria for regulatory acceptance of 3R testing approaches, including a process for collection of real-life data (safe harbour). Pathways for regulatory acceptance of 3R testing approaches are depicted and a new procedure for submission and evaluation of a proposal for regulatory acceptance of 3R testing approaches is described.

A method of setting limits for the purpose of quality assurance

NASA Astrophysics Data System (ADS)

Sanghangthum, Taweap; Suriyapee, Sivalee; Kim, Gwe-Ya; Pawlicki, Todd

2013-10-01

The result from any assurance measurement needs to be checked against some limits for acceptability. There are two types of limits; those that define clinical acceptability (action limits) and those that are meant to serve as a warning that the measurement is close to the action limits (tolerance limits). Currently, there is no standard procedure to set these limits. In this work, we propose an operational procedure to set tolerance limits and action limits. The approach to establish the limits is based on techniques of quality engineering using control charts and a process capability index. The method is different for tolerance limits and action limits with action limits being categorized into those that are specified and unspecified. The procedure is to first ensure process control using the I-MR control charts. Then, the tolerance limits are set equal to the control chart limits on the I chart. Action limits are determined using the Cpm process capability index with the requirements that the process must be in-control. The limits from the proposed procedure are compared to an existing or conventional method. Four examples are investigated: two of volumetric modulated arc therapy (VMAT) point dose quality assurance (QA) and two of routine linear accelerator output QA. The tolerance limits range from about 6% larger to 9% smaller than conventional action limits for VMAT QA cases. For the linac output QA, tolerance limits are about 60% smaller than conventional action limits. The operational procedure describe in this work is based on established quality management tools and will provide a systematic guide to set up tolerance and action limits for different equipment and processes.

Feasibility and Acceptability of Cryptococcal Antigen Screening and Prevalence of Cryptocococcemia in Patients Attending a Resource-Limited HIV/AIDS Clinic in Malawi.

PubMed

Chipungu, Chifundo; Veltman, Jennifer A; Jansen, Perry; Chiliko, Peter; Lossa, Christina; Namarika, Dan; Benner, Blake; Hoffman, Risa M; Bristow, Claire C; Klausner, Jeffrey D

2015-01-01

The World Health Organization (WHO) recommends screening patients living with AIDS to detect and treat early cryptococcal infection. The authors evaluated a cryptococcal antigen (CrAg) screening and treatment program at an HIV/AIDS clinic in Malawi. Eligible patients were of age >18 years, had a CD4 count <100 cells/µL or WHO clinical HIV/AIDS stage III or IV. Of 552 patients who presented for care, 113 were eligible, and all (100%) agreed to CrAg screening. Of them, 2 (1.8%; 95% confidence interval [CI]: 0-4.2%) patients were CrAg positive. Among those with CD4 count <100 cells/µL or WHO stage IV, the CrAg prevalence was 3.5% (95% CI: 0-8.4%) and 5.0% (95% CI: 0-15%), respectively. A CrAg screening program was acceptable to new patients in a Malawian HIV/AIDS clinic. The CrAg prevalence for patients with CD4 count < 100 cells/µL and WHO stage IV was consistent with cost-effectiveness estimates. CrAg screening and treatment programs for patients living with AIDS should be expanded. © The Author(s) 2015.

A randomized, investigator-masked clinical evaluation of the efficacy and safety of clobetasol propionate 0.05% shampoo and tar blend 1% shampoo in the treatment of moderate to severe scalp psoriasis.

PubMed

Griffiths, Christopher E M; Finlay, Andrew Y; Fleming, Colin J; Barker, Jonathan N W N; Mizzi, Fabienne; Arsonnaud, Stéphanie

2006-01-01

The clinical benefit of currently available tar blend shampoos for the treatment of scalp psoriasis is restricted due to their limited efficacy, low cosmetic appeal and potential for carcinogenicity. This 4-week multicentre, randomized, parallel-group, investigator-masked study included 162 subjects and aimed to compare the efficacy, safety and cosmetic acceptability of clobetasol propionate 0.05% shampoo versus a currently marketed tar blend 1% shampoo in subjects with moderate to severe scalp psoriasis. Clobetasol propionate shampoo was superior to tar blend shampoo with respect to all efficacy variables tested (p<0.001): Total and Global Severity Score; erythema; plaque thickening; desquamation; pruritus; total scalp area involved; and the subject's global assessment of clinical improvement. Both treatments were safe and well-tolerated. Furthermore, more subjects indicated that clobetasol propionate shampoo was more cosmetically acceptable than tar blend shampoo. Clobetasol propionate 0.05% shampoo is a good alternative to tar blend shampoo in the treatment of moderate to severe scalp psoriasis.

An Evaluation of the Gap Sizes of 3-Unit Fixed Dental Prostheses Milled from Sintering Metal Blocks.

PubMed

Jung, Jae-Kwan

2017-01-01

This study assessed the clinical acceptability of sintering metal-fabricated 3-unit fixed dental prostheses (FDPs) based on gap sizes. Ten specimens were prepared on research models by milling sintering metal blocks or by the lost-wax technique (LWC group). Gap sizes were assessed at 12 points per abutment (premolar and molar), 24 points per specimen (480 points in a total in 20 specimens). The measured points were categorized as marginal, axial wall, and occlusal for assessment in a silicone replica. The silicone replica was cut through the mesiodistal and buccolingual center. The four sections were magnified at 160x, and the thickness of the light body silicone was measured to determine the gap size, and gap size means were compared. For the premolar part, the mean (standard deviation) gap size was nonsignificantly ( p = 0.139) smaller in the SMB group (68.6 ± 35.6  μ m) than in the LWC group (69.6 ± 16.9  μ m). The mean molar gap was nonsignificantly smaller ( p = 0.852) in the LWC (73.9 ± 25.6  μ m) than in the SMB (78.1 ± 37.4  μ m) group. The gap sizes were similar between the two groups. Because the gap sizes were within the previously proposed clinically accepted limit, FDPs prepared by sintered metal block milling are clinically acceptable.

An Evaluation of the Gap Sizes of 3-Unit Fixed Dental Prostheses Milled from Sintering Metal Blocks

PubMed Central

2017-01-01

This study assessed the clinical acceptability of sintering metal-fabricated 3-unit fixed dental prostheses (FDPs) based on gap sizes. Ten specimens were prepared on research models by milling sintering metal blocks or by the lost-wax technique (LWC group). Gap sizes were assessed at 12 points per abutment (premolar and molar), 24 points per specimen (480 points in a total in 20 specimens). The measured points were categorized as marginal, axial wall, and occlusal for assessment in a silicone replica. The silicone replica was cut through the mesiodistal and buccolingual center. The four sections were magnified at 160x, and the thickness of the light body silicone was measured to determine the gap size, and gap size means were compared. For the premolar part, the mean (standard deviation) gap size was nonsignificantly (p = 0.139) smaller in the SMB group (68.6 ± 35.6 μm) than in the LWC group (69.6 ± 16.9 μm). The mean molar gap was nonsignificantly smaller (p = 0.852) in the LWC (73.9 ± 25.6 μm) than in the SMB (78.1 ± 37.4 μm) group. The gap sizes were similar between the two groups. Because the gap sizes were within the previously proposed clinically accepted limit, FDPs prepared by sintered metal block milling are clinically acceptable. PMID:28246605

Is a pre-analytical process for urinalysis required?

PubMed

Petit, Morgane; Beaudeux, Jean-Louis; Majoux, Sandrine; Hennequin, Carole

2017-10-01

For the reliable urinary measurement of calcium, phosphate and uric acid, a pre-analytical process by adding acid or base to urine samples at laboratory is recommended in order to dissolve precipitated solutes. Several studies on different kind of samples and analysers have previously shown that a such pre-analytical treatment is useless. The objective was to study the necessity of pre-analytical treatment of urine on samples collected using the V-Monovette ® (Sarstedt) system and measured on the analyser Architect C16000 (Abbott Diagnostics). Sixty urinary samples of hospitalized patients were selected (n=30 for calcium and phosphate, and n=30 for uric acid). After acidification of urine samples for measurement of calcium and phosphate, and alkalinisation for measurement of uric acid respectively, differences between results before and after the pre-analytical treatment were compared to acceptable limits recommended by the French society of clinical biology (SFBC). No difference in concentration between before and after pre-analytical treatment of urine samples exceeded acceptable limits from SFBC for measurement of calcium and uric acid. For phosphate, only one sample exceeded these acceptable limits, showing a result paradoxically lower after acidification. In conclusion, in agreement with previous study, our results show that acidification or alkalinisation of urine samples from 24 h urines or from urination is not a pre-analytical necessity for measurement of calcium, phosphate and uric acid.

Developing acceptance limits for measured bearing wear of the Space Shuttle Main Engine high pressure oxidizer turbopump

NASA Technical Reports Server (NTRS)

Genge, Gary G.

1991-01-01

The probabilistic design approach currently receiving attention for structural failure modes has been adapted for obtaining measured bearing wear limits in the Space Shuttle Main Engine high-pressure oxidizer turbopump. With the development of the shaft microtravel measurements to determine bearing health, an acceptance limit was neeed that protects against all known faiure modes yet is not overly conservative. This acceptance criteria limit has been successfully determined using probabilistic descriptions of preflight hardware geometry, empirical bearing wear data, mission requirements, and measurement tool precision as an input for a Monte Carlo simulation. The result of the simulation is a frequency distribution of failures as a function of preflight acceptance limits. When the distribution is converted into a reliability curve, a conscious risk management decision is made concerning the acceptance limit.

Evaluation of shear bond strength of orthodontic brackets using trans-illumination technique with different curing profiles of LED light-curing unit in posterior teeth.

PubMed

Heravi, Farzin; Moazzami, Saied Mostafa; Ghaffari, Negin; Jalayer, Javad; Bozorgnia, Yasaman

2013-11-21

Although using light-cured composites for bonding orthodontic brackets has become increasingly popular, curing light cannot penetrate the metallic bulk of brackets and polymerization of composites is limited to the edges. Limited access and poor direct sight may be a problem in the posterior teeth. Meanwhile, effectiveness of the trans-illumination technique is questionable due to increased bucco-lingual thickness of the posterior teeth. Light-emitting diode (LED) light-curing units cause less temperature rise and lower risk to the pulpal tissue. The purpose of this study was to evaluate the clinical effectiveness of trans-illumination technique in bonding metallic brackets to premolars, using different light intensities and curing times of an LED light-curing unit. Sixty premolars were randomly divided into six groups. Bonding of brackets was done with 40- and 80-s light curing from the buccal or lingual aspect with different intensities. Shear bond strengths of brackets were measured using a universal testing machine. Data were analyzed by one-way analysis of variance test and Duncan's post hoc test. The highest shear bond belonged to group 2 (high intensity, 40 s, buccal) and the lowest belonged to group 3 (low intensity, 40 s, lingual). Bond strength means in control groups were significantly higher than those in experimental groups. In all experimental groups except group 6 (80 s, high intensity, lingual), shear bond strength was below the clinically accepted values. In clinical limitations where light curing from the same side of the bracket is not possible, doubling the curing time and increasing the light intensity during trans-illumination are recommended for achieving acceptable bond strengths.

Challenges in Clinical Management of Radiation-Induced Illnesses in Exploration Spaceflight

NASA Technical Reports Server (NTRS)

Blue, Rebecca; Chancellor, Jeffery; Suresh, Rahul; Carnell, Lisa; Reyes, David; Nowadly, Craig; Antonsen, Erik

2018-01-01

Historical solar particle events (SPEs) provide context for some understanding of acute radiation exposure risk to astronauts traveling outside of low Earth orbit. Modeling of potential doses delivered to exploration crewmembers anticipates limited radiation-induced health impacts, including prodromal symptoms of nausea, emesis, and fatigue, but suggests that more severe clinical manifestations are unlikely. Recent large animal-model research in space-analogs closely mimicking SPEs has identified coagulopathic events independent of the hematopoietic sequelae of higher radiation doses, similar in manifestation to disseminated intravascular coagulation (DIC). We explored the challenges of clinical management of radiation-related clinical manifestations, using currently accepted modeling techniques and anticipated physiological sequelae, to identify medical capabilities needed to successfully manage SPE-induced radiation illnesses during exploration spaceflight.

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.

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

Cross-sectional study of Pfizer-sponsored clinical trials: assessment of time to publication and publication history.

PubMed

Mooney, LaVerne A; Fay, Lorna

2016-07-18

To estimate the proportion of Pfizer-sponsored clinical trials that completed in 2010 and are published as manuscripts in the peer-reviewed literature, and to assess the manuscript development history. Retrospective, cross-sectional analysis. Clinical trials registered in ClinicalTrials.gov that completed in 2010 for approved, Pfizer prescription products in patients or vaccines in healthy participants. The proportion of studies for which the primary outcome(s) was published and the median time from study completion to publication. The manuscript development history included the number of times a manuscript was submitted before it was accepted for publication. Among registered clinical trials for which Pfizer was the sponsor that completed in 2010, 76 met all inclusion criteria. The primary outcome(s) for 65 (85%) studies was published in 71 manuscripts; the median time to publication was 31 months (range 3-63 months). Of the remaining 11 studies, 2 had been submitted to at least one journal, 2 had not yet been submitted and 7 had no plans to publish because the study had terminated early due to recruitment challenges. Manuscripts accepted at the first choice journal were published at median time of 28 months (range 8-63, n=31), those accepted at second choice journal were published at 32 months (3-45, n=19), and for those accepted at third choice journal, it was 40 months (range 24-53, n=13). The publication rate and median time to publication from study completion for Pfizer-sponsored studies were comparable to those previously reported for combined analyses of industry and non-industry sectors. Opportunities exist for sponsors, authors and journals to explore ideas that would facilitate more timely publication for clinical trial results. However, to be effective, such changes may need to revisit the entire publication process. 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/

Cognitive Behavioural Analysis System of Psychotherapy (CBASP) for chronic depression: clinical characteristics and six month clinical outcomes in an open case series.

PubMed

Swan, John S; Macvicar, Robert; Christmas, David; Durham, Rob; Rauchhaus, Petra; McCullough, James P; Matthews, Keith

2014-01-01

Evidence-based guidance on how best to treat chronic depression is limited. Cognitive Behavioural Analysis System of Psychotherapy (CBASP) has shown some promise with this 'difficult-to-treat' clinical group. This case series was designed to assess the acceptability and utility of this novel treatment in routine clinical practice within the U.K. National Health Service. We offered an open trial of CBASP to a cohort of 115 referred patients within primary and secondary care. Diagnostic interview and standardised outcome measures were administered before and after 6 months of CBASP with a trained, accredited therapist. Seventy-four patients entered therapy, with 46 completing. 30% met criteria for remission (≤ 8 HRSD-24 score) and a further 30% met criteria for clinically significant change (> 8 and ≤15 HRSD-24 plus 50% reduction in baseline score). Thirty-nine per cent made "No change". Group measures of quality of life, social functioning and interpersonal functioning also improved. This was an open study design with a moderate sample size and no control group. Ratings were not completed using a blinded procedure. CBASP is an acceptable therapy for a large proportion of patients with chronic depression and was associated with clinically significant change in 60% of completers. © 2013 Published by Elsevier B.V.

Appropriate clinical use of human leukocyte antigen typing for coeliac disease: an Australasian perspective

PubMed Central

Tye-Din, J A; Cameron, D J S; Daveson, A J; Day, A S; Dellsperger, P; Hogan, C; Newnham, E D; Shepherd, S J; Steele, R H; Wienholt, L; Varney, M D

2015-01-01

The past decade has seen human leukocyte antigen (HLA) typing emerge as a remarkably popular test for the diagnostic work-up of coeliac disease with high patient acceptance. Although limited in its positive predictive value for coeliac disease, the strong disease association with specific HLA genes imparts exceptional negative predictive value to HLA typing, enabling a negative result to exclude coeliac disease confidently. In response to mounting evidence that the clinical use and interpretation of HLA typing often deviates from best practice, this article outlines an evidence-based approach to guide clinically appropriate use of HLA typing, and establishes a reporting template for pathology providers to improve communication of results. PMID:25827511

[External quality assessment in clinical biochemistry laboratories: pilot study in 11 laboratories of Lomé (Togo)].

PubMed

Kouassi, Kafui; Fétéké, Lochina; Assignon, Selom; Dorkenoo, Ameyo; Napo-Koura, Gado

2015-01-01

This study aims to evaluate the performance of a few biochemistry analysis and make recommendations to the place of the stakeholders. It is a cross-sectional study conducted between the October 1(st), 2012 and the July 31, 2013 bearing on the results of 5 common examinations of clinical biochemistry, provided by 11 laboratories volunteers opening in the public and private sectors. These laboratories have analysed during the 3 cycles, 2 levels (medium and high) of serum concentration of urea, glucose, creatinine and serum aminotransferases. The performance of laboratories have been determined from the acceptable limits corresponding to the limits of total errors, defined by the French Society of Clinical Biology (SFBC). A system of internal quality control is implemented by all laboratories and 45% of them participated in international programs of external quality assessment (EQA). The rate of acceptable results for the entire study was of 69%. There was a significant difference (p<0.002) between the performance of the group of laboratories engaged in a quality approach and the group with default implementation of the quality approach. Also a significant difference was observed between the laboratories of the central level and those of the peripheral level of our health system (p<0.047). The performance of the results provided by the laboratories remains relatively unsatisfactory. It is important that the Ministry of Health put in place a national program of EQA with mandatory participation.

Developing Practice Guidelines for Psychoanalysis

PubMed Central

GRAY, SHEILA HAFTER

1996-01-01

Consensus-based practice guidelines codify clinical intelligence and the rich oral tradition in medicine. Because they reflect actual practice, they are readily accepted by clinicians as a basis for external review. This article illustrates the development of guidelines for a psychoanalytic approach to the large pool of patients who present with a depression. It suggests an integrated biopsychosocial approach to these individuals that is useful in current practice, and it offers propositions that may be tested in future research undertakings. Eventually, practice guidelines such as these may form the basis of economical systems of health care that avoid arbitrary, clinically untenable limitations on services. PMID:22700290

Shielding design of the Mayo Clinic Scottsdale cyclotron vault

NASA Astrophysics Data System (ADS)

Riper, Kenneth A. Van; Metzger, Robert L.; Nelson, Kevin

2017-09-01

Mayo Clinic Scottsdale (Scottsdale, Arizona) is building a cyclotron vault containing a cyclotron with adjacent targets and a beam line leading to an external target. The targets are irradiated by high energy (15 to 16.5 MeV) protons for the production of radioisotopes. We performed Monte Carlo radiation transport simulations to calculate the radiation dose outside of the vault during irradiation of the cyclotron and external targets. We present the Monte Carlo model including the geometry, sources, and variance reduction methods. Mesh tallies surrounding the vault show the external dose rate is within acceptable limits.

The treatment of Dupuytren disease.

PubMed

Desai, Shaunak S; Hentz, Vincent R

2011-05-01

The treatment of progressive Dupuytren contractures has historically been and continues to be largely surgical. Although a number of surgical interventions do exist, limited palmar fasciectomy continues to be the most common and widely accepted treatment option. Until recently, nonsurgical options were limited and clinically ineffective. However, the commercial availability and recent approval of collagenase clostridium histolyticum now provides practitioners with a nonsurgical approach to this disease. This article presents a comprehensive review of the surgical and nonsurgical treatments of Dupuytren disease, with a focus on collagenase. Copyright © 2011 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Systematic Review of Integrated Medical and Psychiatric Self-Management Interventions for Adults with Serious Mental Illness

PubMed Central

Whiteman, Karen L.; Naslund, John A.; DiNapoli, Elizabeth A.; Bruce, Martha L.; Bartels, Stephen J.

2016-01-01

Objective Adults with serious mental illness are disproportionately affected by medical comorbidity, earlier onset of disease, and premature mortality. Integrated self-management interventions have been developed to address both medical and psychiatric illnesses. This systematic review aimed to: review the evidence of the effect of self-management interventions targeting both medical and psychiatric illnesses and evaluate the potential for implementation. Methods Databases including CINAHL, Cochrane Central, Ovid Medline, PsycINFO, and Web of Science were searched for articles published between 1946 and July 2015. Studies evaluating integrated medical and psychiatric self-management interventions for adults with schizophrenia spectrum or mood disorders and medical comorbidity were included. Results Fifteen studies reported on nine interventions (i.e., nine randomized control trials, six pre/post designs). Most studies demonstrated feasibility, acceptability, and preliminary effectiveness; however, clinical effectiveness could not be established in most of the studies due to methodological limitations. Factors identified that may deter implementation included operating costs, impractical length of the intervention, and the workforce needs of these interventions. Conclusions Integrated medical and psychiatric illness self-management interventions appear feasible and acceptable, with high potential for clinical effectiveness. However, implementation considerations were rarely considered in intervention development, contributing to limited uptake and reach in real-world settings. PMID:27301767

Impact of deploying multiple point-of-care tests with a 'sample first' approach on a sexual health clinical care pathway. A service evaluation.

PubMed

Harding-Esch, Emma M; Nori, Achyuta V; Hegazi, Aseel; Pond, Marcus J; Okolo, Olanike; Nardone, Anthony; Lowndes, Catherine M; Hay, Phillip; Sadiq, S Tariq

2017-09-01

To assess clinical service value of STI point-of-care test (POCT) use in a 'sample first' clinical pathway (patients providing samples on arrival at clinic, before clinician consultation). Specific outcomes were: patient acceptability; whether a rapid nucleic acid amplification test (NAAT) for Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) could be used as a POCT in practice; feasibility of non-NAAT POCT implementation for Trichomonas vaginalis (TV) and bacterial vaginosis (BV); impact on patient diagnosis and treatment. Service evaluation in a south London sexual health clinic. Symptomatic female and male patients and sexual contacts of CT/NG-positive individuals provided samples for diagnostic testing on clinic arrival, prior to clinical consultation. Tests included routine culture and microscopy; CT/NG (GeneXpert) NAAT; non-NAAT POCTs for TV and BV. All 70 (35 males, 35 females) patients approached participated. The 'sample first' pathway was acceptable, with >90% reporting they were happy to give samples on arrival and receive results in the same visit. Non-NAAT POCT results were available for all patients prior to leaving clinic; rapid CT/NG results were available for only 21.4% (15/70; 5 males, 10 females) of patients prior to leaving clinic. Known negative CT/NG results led to two females avoiding presumptive treatment, and one male receiving treatment directed at possible Mycoplasma genitalium infection causing non-gonococcal urethritis. Non-NAAT POCTs detected more positives than routine microscopy (TV 3 vs 2; BV 24 vs 7), resulting in more patients receiving treatment. A 'sample first' clinical pathway to enable multiple POCT use was acceptable to patients and feasible in a busy sexual health clinic, but rapid CT/NG processing time was too long to enable POCT use. There is need for further development to improve test processing times to enable POC use of rapid NAATs. 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/.

Retail Health Clinics: A Policy Position Paper From the American College of Physicians.

PubMed

Daniel, Hilary; Erickson, Shari

2015-12-01

Retail health clinics are walk-in clinics located in retail stores or pharmacies that are typically staffed by nurse practitioners or physician assistants. When they entered the marketplace in the early 2000s, retail clinics offered a limited number of services for low-acuity conditions that were paid for out of pocket by the consumer. Over the past decade, business models for these clinics have evolved to accept public and private health insurance, and some are expanding their services to include diagnosis, treatment, and management of chronic conditions. Retail health clinics are one of several methods of health care delivery that challenge the traditional primary care delivery model. The positions and recommendations offered by the American College of Physicians in this paper are intended to establish a framework that underscores patient safety, communication, and collaboration among retail health clinics, physicians, and patients.

Characteriation of clinical data packages using foreign data in new drug applications in Japan.

PubMed

Tanaka, M; Nagata, T

2008-09-01

The objective of this research was to characterize clinical data packages (CDPs) of new drug applications (NDAs) using foreign data based on the International Conference on Harmonization (ICH) E5 guideline. Official review reports of NDAs approved in Japan between January 1999 and April 2005 were examined. Those NDAs considered by the official reviewers to be approved based on the ICH E5 guideline (E5-NDAs) were identified and classified into six categories of approval requirements in Japan. The details of pivotal clinical efficacy studies in the CDPs were examined. Forty-one NDAs were identified as E5-NDAs. Pivotal clinical studies conducted in Japan were required by the E5-NDAs, except for nine of those in which the foreign clinical studies reduced Japanese clinical studies in the CDPs. Given the differences in approval requirements among regions, the acceptability of foreign clinical data to Japanese approval is limited.

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials.

PubMed

Rose, Klaus; Kummer, Hans

2015-05-28

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)'s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA's PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients.

Maternal support for human papillomavirus vaccination in Honduras.

PubMed

Perkins, Rebecca B; Langrish, Sarah M; Cotton, Deborah J; Simon, Carol J

2011-01-01

Cervical cancer is a leading cause of cancer death for women in Latin America, and vaccinating against human papillomavirus (HPV) has the potential to limit this disease. We sought to determine Honduran women's awareness of HPV vaccination and interest in vaccinating their daughters against HPV. We interviewed mothers aged ≥17 at primary care clinics in Honduras. First, we collected demographic information and assessed knowledge related to cervical cancer prevention and awareness of HPV and HPV vaccination. Because most participants were not familiar with HPV, education about the relationships among HPV, sexual activity, and cervical cancer was provided before we asked participants if they would accept HPV vaccination for a 9-year-old daughter. We used multivariable logistic regression to determine predictors of vaccine acceptance. We interviewed 632 mothers. Only 13% had heard of HPV vaccination before the interview. After education, 91% would accept HPV vaccination for a 9-year-old daughter. Mothers who intended to vaccinate knew more at baseline about cervical cancer prevention than did those who did not endorse vaccination. Demographic characteristics did not predict vaccine acceptance. Few Honduran mothers were aware of HPV or HPV vaccination. However, most Honduran mothers would accept HPV vaccination for their daughters after receiving education about the relationship between HPV infection and cervical cancer. Baseline cervical cancer knowledge was associated with vaccine acceptance.

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.

Using conjoint analysis to determine the impact of product and user characteristics on acceptability of rectal microbicides for HIV prevention among Peruvian men who have sex with men.

PubMed

Tang, Eric C; Galea, Jerome T; Kinsler, Janni J; Gonzales, Pedro; Sobieszczyk, Magdalena E; Sanchez, Jorge; Lama, Javier R

2016-05-01

Men who have sex with men (MSM) are in need of novel and acceptable HIV prevention interventions. In Peru, a Phase II clinical trial was recently completed evaluating rectally applied tenofovir gel among Peruvian MSM and transgender women. If deemed safe and acceptable, the product could move into efficacy testing, but acceptability data for similar products are needed now in order to prepare for future implementation. Peru is in need of expanded, national acceptability data among likely users. Using conjoint analysis of an online cross-sectional survey taken by 1008 Peruvian MSM and transgender women, we tested the acceptability of eight hypothetical rectal microbicide (RM) products comprising six, dual-value attributes. We also assessed the relationship of select product attributes with sample characteristics. Highest acceptability was found for a RM that was 90% effective, used before and after sex, without side effects, costing approximately $0.30, had no prescription requirement and had a single-use applicator. Product effectiveness and presence of side effects were the factors most likely to drive RM acceptance and use. Education, sexual orientation, sexual role and concern for HIV infection were also related to aspects of RM acceptability. RM acceptability was high, confirming the results of earlier, smaller studies and placing confidence in the acceptability of RMs. Analysis of the relationships with product attributes and sample characteristics underscore the need to consider the impact of factors such as sexual orientation, sexual role, level of education and concern for HIV acquisition on RM acceptability. 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 survey regarding acceptability of oral emergency contraception according to the posited mechanism of action.

PubMed

Willetts, S J; MacDougall, M; Cameron, S T

2017-08-01

The objective was to determine the acceptability to women of oral emergency contraception (EC) that works by inhibiting ovulation, preventing implantation or disrupting implantation, and also to determine the characteristics of women associated with the acceptability of each posited mechanism of action. Women completed a self-administered, anonymous questionnaire asking whether they would consider using an EC pill based on each of three hypothetical mechanisms of action: inhibiting ovulation, preventing implantation or disrupting implantation. The questionnaire was distributed among women in Edinburgh, UK, (a) presenting for EC at a community pharmacy, (b) attending a clinic for insertion of intrauterine contraception (IUC) or (c) attending a clinic for an induced abortion. Descriptive analyses stratified women according to healthcare setting and personal characteristics. Univariable and multivariable analyses were used to establish factors which may predict acceptability of each EC pill's mechanism of action. Four hundred and nineteen out of 458 (91%) women responded to the survey. Overall, women reported that EC would be acceptable if it worked by inhibiting ovulation (89%), preventing implantation (83%) or disrupting implantation (75%). Among women seeking abortion, more would accept an EC pill which disrupted implantation compared to women seeking IUC (odds ratio, 2.19; 95% confidence interval, 1.30-3.69; p=.004). Based on multivariable analyses, factors associated with acceptability included previous use of EC, previously holding strong views against abortion and having had a previous abortion. For each of the posited mechanisms of action, a majority of women surveyed would be willing to consider oral EC to prevent unintended pregnancy. The scope of the study was limited, and further work on the views of women in the wider population is needed. This is important as the development of such drugs to prevent pregnancy is likely to raise political and ethical challenges, particularly in relation to disruption of implantation. Copyright © 2017 Elsevier Inc. All rights reserved.

Interventions for maintaining nasogastric feeding after stroke: An integrative review of effectiveness and acceptability.

PubMed

Mahoney, Catherine; Veitch, Linda

2018-02-01

To investigate the effectiveness and acceptability of interventions for maintaining nasogastric tubes in adult stroke patients. Internationally, incidence of cerebral vascular disease continues to increase and stroke is the largest cause of complex disability in adults. Dysphagia is common following a stroke which necessitates feeding via a nasogastric tube. Nasogastric tubes are not well tolerated by stroke patients and may be frequently dislodged. Hence, interventions such as tape, the nasal bridle/loop or hand mittens may be used to maintain nasogastric tube position. However, evidence around the effectiveness and acceptability of these interventions has not been reviewed and synthesised. Integrative literature review. Database searches in MEDLINE, PubMed, CINAHL, Scopus, Cochrane and EMBASE; manual reference list searches. Seven studies met the eligibility criteria and were included in the review. Evidence for the effectiveness of nasal bridle/loop and hand mittens to maintain nasogastric tube position in patients after a stroke is spare and methodologically poor, and especially limited around hand mittens use. There is insufficient evidence about the acceptability of both nasal bridle/loop and hand mittens among stroke patients. Current clinical practice is underpinned by assumptions around the acceptability of nasal bridle/loop and hand mittens to secure nasogastric tubes. This results in reliance on consensual judgement between professional, patients and their families to guide their use among individuals with dysphagia after stroke. Further research is required to assess the effectiveness of hand mittens and acceptability of both nasal bridle/loop and hand mittens among stroke patients to inform guideline development. Given the lack of evidence on the acceptability of hand mittens and nasal bridle/loop among stroke patients to inform evidence-based guidelines and protocols, healthcare professionals should reach consensus on their use by exercising clinical judgement and through consultation with patients (if possible) and their families. © 2017 John Wiley & Sons Ltd.

Factors impacting time to acceptance and publication for peer-reviewed publications.

PubMed

Toroser, Dikran; Carlson, Janice; Robinson, Micah; Gegner, Julie; Girard, Victoria; Smette, Lori; Nilsen, Jon; O'Kelly, James

2017-07-01

Timely publication of data is important for the medical community and provides a valuable contribution to data disclosure. The objective of this study was to identify and evaluate times to acceptance and publication for peer-reviewed manuscripts, reviews, and letters to the editor. Key publication metrics for published manuscripts, reviews, and letters to the editor were identified by eight Amgen publications professionals. Data for publications submitted between 1 January 2013 and 1 November 2015 were extracted from a proprietary internal publication-tracking database. Variables included department initiating the study, publication type, number of submissions per publication, and the total number of weeks from first submission to acceptance, online publication, and final publication. A total of 337 publications were identified, of which 300 (89%) were manuscripts. Time from submission to acceptance and publication was generally similar between clinical and real-world evidence (e.g. observational and health economics studies) publications. Median (range) time from first submission to acceptance was 23.4 (0.2-226.2) weeks. Median (range) time from first submission to online (early-release) publication was 29.7 (2.4-162.6) weeks. Median (range) time from first submission to final (print) publication was 36.2 (2.8-230.8) weeks. Time from first submission to acceptance, online publication, and final publication increased accordingly with number of submissions required for acceptance, with similar times noted between each subsequent submission. Analysis of a single-company publication database showed that the median time for manuscripts to be fully published after initial submission was 36.2 weeks, and time to publication increased accordingly with the number of submissions. Causes for multiple submissions and time from clinical trial completion to first submission were not assessed; these were limitations of the study. Nonetheless, publication planners should consider these results when evaluating timelines and identifying potential journals early in the publication planning process.

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.

Kangaroo care with twins: a case study in which one infant did not respond as expected.

PubMed

Jarrell, Julia R; Ludington-Hoe, Susan M; Abouelfettoh, Amel

2009-01-01

The purposes were to relate responses (including unacceptable ones) of twins to shared kangaroo care (KC), to provide explanations for the unexpected responses, and to offer suggestions for safe nursing practice. A descriptive, evaluative case study was conducted. Both twins received KC while their vital signs and maternal breast temperatures were manually recorded every 30 seconds. Descriptive statistics were computed. Identical twins, born to a 19-year-old African-American primigravada, were 34 3/7 weeks postconceptional age with weights of 1,760 and 1,480 g, respectively, when tested. Preterm labor resulted in spontaneous vaginal birth at 30 weeks gestation. Infant heart and respiratory rates, oxygen saturations, abdominal temperatures, and maternal breast temperatures. Infant A's vital signs exceeded acceptable clinical limits during shared KC; vital signs returned to normal range once Infant A was returned to the incubator. Infant B's vital signs approximated clinically acceptable ranges throughout the session. Breast temperatures did not differ. Individuality mandates vigilant assessment of infant responses to shared KC.

Giving Voice to Study Volunteers: Comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research

PubMed Central

Roberts, Laura Weiss; Kim, Jane Paik

2014-01-01

Motivation Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Methods Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Results Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy=−0.04, CI [−0.46, 0.39]; physically ill – healthy= −0.13, CI [−0.62, −.36]). Conclusions Clinical research volunteers and healthy clinical research-“naive” individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. PMID:24931849

Giving voice to study volunteers: comparing views of mentally ill, physically ill, and healthy protocol participants on ethical aspects of clinical research.

PubMed

Roberts, Laura Weiss; Kim, Jane Paik

2014-09-01

Ethical controversy surrounds clinical research involving seriously ill participants. While many stakeholders have opinions, the extent to which protocol volunteers themselves see human research as ethically acceptable has not been documented. To address this gap of knowledge, authors sought to assess views of healthy and ill clinical research volunteers regarding the ethical acceptability of human studies involving individuals who are ill or are potentially vulnerable. Surveys and semi-structured interviews were used to query clinical research protocol participants and a comparison group of healthy individuals. A total of 179 respondents participated in this study: 150 in protocols (60 mentally ill, 43 physically ill, and 47 healthy clinical research protocol participants) and 29 healthy individuals not enrolled in protocols. Main outcome measures included responses regarding ethical acceptability of clinical research when it presents significant burdens and risks, involves people with serious mental and physical illness, or enrolls people with other potential vulnerabilities in the research situation. Respondents expressed decreasing levels of acceptance of participation in research that posed burdens of increasing severity. Participation in protocols with possibly life-threatening consequences was perceived as least acceptable (mean = 1.82, sd = 1.29). Research on serious illnesses, including HIV, cancer, schizophrenia, depression, and post-traumatic stress disorder, was seen as ethically acceptable across respondent groups (range of means = [4.0, 4.7]). Mentally ill volunteers expressed levels of ethical acceptability for physical illness research and mental illness research as acceptable and similar, while physically ill volunteers expressed greater ethical acceptability for physical illness research than for mental illness research. Mentally ill, physically ill, and healthy participants expressed neutral to favorable perspectives regarding the ethical acceptability of clinical research participation by potentially vulnerable subpopulations (difference in acceptability perceived by mentally ill - healthy = -0.04, CI [-0.46, 0.39]; physically ill - healthy = -0.13, CI [-0.62, -.36]). Clinical research volunteers and healthy clinical research-"naïve" individuals view studies involving ill people as ethically acceptable, and their responses reflect concern regarding research that poses considerable burdens and risks and research involving vulnerable subpopulations. Physically ill research volunteers may be more willing to see burdensome and risky research as acceptable. Mentally ill research volunteers and healthy individuals expressed similar perspectives in this study, helping to dispel a misconception that those with mental illness should be presumed to hold disparate views. Copyright © 2014 Elsevier Ltd. All rights reserved.

An exploration of the feasibility of radiation therapist participation in treatment reviews

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

Monk, Clare Maree; Wrightson, Stephanie Jane; Smith, Tony Neil

2013-09-15

As radiation oncologists' (ROs') workload has increased over time, treatment review clinics have become recognized as an area of RO practice into which radiation therapist (RT) practice could extend. There has been limited utilization of RTs in this role in Australia and a paucity of data on the acceptability and opinions regarding RTs practising in this role in an Australian context. The purpose of this audit was to investigate the feasibility of RT participation in review clinics at Calvary Mater Newcastle. Feasibility was determined by two methods: an audit of 200 treatment reviews to determine medical intervention (MI) levels requiredmore » and a survey of 80 clinical staff to explore attitudes towards RT participation in clinics. Medical intervention was required in 59% (n = 118) of observed reviews, with the lowest being for breast (33%) and prostate (28%) cancers. MI peaked at 73% between fractions 16–20 and was lowest early and late in the treatment period at 48%. There were 60 responses to the staff survey. All but one respondent agreed that RTs would be willing to participate in treatment review clinics, but all five consultant ROs indicated they would not be willing to delegate reviews to RTs. Neither feasibility measure reached acceptable levels to recommend RT participation in treatment review clinics. Further investigation and RT education are required to help meet the future RO workforce shortfall. As MI rates are lowest for breast and prostate cancer RT participation could be targeted to these clinics.« less

Riddles of masculinity: gender, bisexuality, and thirdness.

PubMed

Fogel, Gerald I

2006-01-01

Clinical examples are used to illuminate several riddles of masculinity-ambiguities, enigmas, and paradoxes in relation to gender, bisexuality, and thirdness-frequently seen in male patients. Basic psychoanalytic assumptions about male psychology are examined in the light of advances in female psychology, using ideas from feminist and gender studies as well as important and now widely accepted trends in contemporary psychoanalytic theory. By reexamining basic assumptions about heterosexual men, as has been done with ideas concerning women and homosexual men, complexity and nuance come to the fore to aid the clinician in treating the complex characterological pictures seen in men today. In a context of rapid historical and theoretical change, the use of persistent gender stereotypes and unnecessarily limiting theoretical formulations, though often unintended, may mask subtle countertransference and theoretical blind spots, and limit optimal clinical effectiveness.

75 FR 7934 - Airworthiness Directives; McCauley Propeller Systems 1A103/TCM Series Propellers

Federal Register 2010, 2011, 2012, 2013, 2014

2010-02-23

... with cracks that do not meet acceptable limits, and rework of propellers with cracks that meet..., replacement of propellers with cracks that do not meet acceptable limits, and rework of propellers with cracks... propeller hub, removal from service of propellers with cracks that do not meet acceptable limits, and rework...

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.

Piecemeal deglutition and dysphagia limit in normal subjects and in patients with swallowing disorders.

PubMed Central

Ertekin, C; Aydoğdu, I; Yüceyar, N

1996-01-01

OBJECTIVE: Before the advanced evaluation of deglutition and selection of a treatment method, objective screening methods are necessary for patients with dysphagia. In this study a new electroclinical test was established to evaluate patients with dysphagia. METHODS: This test is based on determining piecemeal deglutition; which is a physiological phenomenon occurring when a bolus of a large volume is divided into two or more parts which are swallowed successively. The combined electrophysiological and mechanical method used to record laryngeal movements detected by a piezoelectric transducer, and activities of the related submental integrated EMG (SM-EMG)-and sometimes the cricopharyngeal muscle of the upper oesophageal sphincter (CP-EMG)-were performed during swallowing. Thirty normal subjects and 66 patients with overt dysphagia of neurogenic origin were investigated after detailed clinical evaluation. Twenty patients with a potential risk of dysphagia, but who were normal clinically at the time of investigation, were also evaluated to determine the specificity of the test. All subjects were instructed to swallow doses of water, gradually increasing in quantity from 1 ml to 20 ml, and any recurrence of the signals related to swallowing within the eight seconds was accepted as a sign of dysphagia limit. RESULTS: In normal subjects as well as in the patients without dysphagia, piecemeal deglutition was never seen with less than 20 ml water. This volume was therefore accepted as the lower limit of piecemeal deglutition. In patients with dysphagia, dysphagia limits were significantly lower than those of normal subjects. CONCLUSION: The method is a highly specific and sensitive test for the objective evaluation of oropharyngeal dysphagia even in patients with suspected dysphagia of neurogenic origin. It can also be safely and simply applied in any EMG laboratory. PMID:8937344

Use of tocilizumab in systemic sclerosis: A brief literature review.

PubMed

Fernández-Codina, A; Fernández-Fernández, J; Fernández-Pantiga, A

2018-03-27

The available treatments for systemic sclerosis (SS) have limited effectiveness. Treatment with tocilizumab (TCZ), a biological drug that inhibits interleukin 6 (IL-6), has recently been proposed. In this study, we conducted a literature review to assess the safety and efficacy of TCZ in SS. We found 52 articles, 10 of which we selected after evaluating the articles. In a randomised clinical trial, TCZ showed a nonsignificant improvement in the degree of skin induration, while another observational study showed neutral results. In this same clinical trial, the functional respiratory parameters showed a certain degree of stabilization. The safety profile of TCZ is acceptable; however, the current evidence regarding treatment of SS with TCZ is highly limited, although the drug could have a beneficial effect in skin disorder. New clinical trials are needed to determine the usefulness of TCZ in SS. Copyright © 2018 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

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

Clinical use of the Mayo-Portland Adaptability Inventory in rehabilitation after paediatric acquired brain injury.

PubMed

Oddson, Bruce; Rumney, Peter; Johnson, Patricia; Thomas-Stonell, Nancy

2006-11-01

The Mayo-Portland Adaptability Inventory (MPAI; designed to be administered by clinicians) is a popular measure of disability following head injury in adults. Its acceptability, validity, and reliability were assessed for use with children. There were 335 children and adolescents (215 males, 120 females) aged between 1 and 19 years at injury (median age 9y 8mo [SD 5y]) in our sample. The test was acceptable to respondents, rapidly and easily administered, and required only small modifications. It demonstrated validity against client and parent reports of major symptoms. It demonstrated test-retest reliability within the limitations of our data and excellent interrater accord. Consequently, the MPAI is recommended for paediatric use for evaluating rehabilitation needs and therapy outcome.

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.

Illness cognitions and the associated socio-demographic and clinical factors in Chinese women with breast cancer.

PubMed

Han, Jing; Liu, Jun-E; Qiu, Hui; Nie, Zhi-Hong; Su, Ya-Li

2018-02-01

Illness cognitions are important mediators between disease and psychological adjustment. Evidence related to illness cognitions among patients with breast cancer remains limited. The purpose of this study was to examine illness cognitions among Chinese women with breast cancer and associations with socio-demographic and clinical factors. A cross-sectional study was carried out involving 313 women with breast cancer recruited from a general hospital and a social cancer support club in Beijing from October 2016 to May 2017. Data were collected using the Illness Cognition Questionnaire. Participants reported positive overall cognition regarding breast cancer (helplessness, 13.70 ± 4.24; acceptance, 16.86 ± 4.30; perceived benefits, 17.93 ± 3.86). A multiple regression model indicated that six factors were associated with illness cognitions: treatment phase of disease, having no children, not returning to work (positive associations with helplessness, negative associations with acceptance; age (negative associations with helplessness, positive associations with acceptance); treatment phase of disease, having no medical insurance (negative associations with perceived benefit); and disease duration (positive associations with acceptance). This study reports on the presence of different illness cognitions in Chinese women with breast cancer and the associated factors, and the results could help oncology medical and nursing staff identify risk factors for poor emotional adjustment to breast cancer and the patients who may benefit from interventions aimed at improving the presence of positive illness cognitions. Copyright © 2017 Elsevier Ltd. All rights reserved.

Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy

PubMed Central

Bricker, Jonathan B.; Mull, Kristin; Kientz, Julie A.; Vilardaga, Roger M.; Mercer, Laina D.; Akioka, Katrina; Heffner, Jaimee L.

2014-01-01

Background There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered Acceptance and Commitment Therapy (ACT) application for smoking cessation versus an application following US Clinical Practice Guidelines. Method Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (N = 196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p <.0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n = 88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:25085225

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.

Segmental stiff skin syndrome (SSS): A distinct clinical entity.

PubMed

Myers, Kathryn L; Mir, Adnan; Schaffer, Julie V; Meehan, Shane A; Orlow, Seth J; Brinster, Nooshin K

2016-07-01

Stiff skin syndrome (SSS) is a noninflammatory, fibrosing condition of the skin, often affecting the limb girdles. We present 4 new patients with SSS with largely unilateral, segmental distribution. To date, reported cases of SSS have been grouped based on generally accepted clinical and histopathologic findings. The purpose of this study was to analyze differences in clinical and histopathologic findings between previously reported SSS cases. This is a retrospective review of 4 new cases and 48 previously published cases of SSS obtained from PubMed search. Of 52 total cases, 18 (35%) were segmentally distributed and 34 (65%) were widespread. The average age of onset was 4.1 years versus 1.6 years for segmental versus widespread SSS, respectively. Limitation in joint mobility affected 44% of patients with segmental SSS and 97% of patients with widespread SSS. Histopathologic findings were common between the 2 groups. This was a retrospective study of previously published cases limited by the completeness and accuracy of the reviewed cases. We propose a distinct clinical entity, segmental SSS, characterized by a segmental distribution, later age of onset, and less severe functional limitation. Both segmental SSS and widespread SSS share common diagnostic histopathologic features. Copyright © 2016 American Academy of Dermatology, Inc. All rights reserved.

Assessment and Treatment of Cognition and Communication Skills in Adults With Acquired Brain Injury via Telepractice: A Systematic Review.

PubMed

Coleman, Jaumeiko J; Frymark, Tobi; Franceschini, Nicole M; Theodoros, Deborah G

2015-05-01

This is a systematic review of assessment and treatment of cognitive and communicative abilities of individuals with acquired brain injury via telepractice versus in person. The a priori clinical questions were informed by previous research that highlights the importance of considering any functional implications of outcomes, determining disorder- and setting-specific concerns, and measuring the potential impact of diagnostic accuracy and treatment efficacy data on interpretation of findings. A literature search of multiple databases (e.g., PubMed) was conducted using key words and study inclusion criteria associated with the clinical questions. Ten group studies were accepted that addressed assessment of motor speech, language, and cognitive impairments; assessment of motor speech and language activity limitations/participation restrictions; and treatment of cognitive impairments and activity limitations/participation restrictions. In most cases, equivalence of outcomes was noted across service delivery methods. Limited findings, lack of diagnostic accuracy and treatment efficacy data, and heterogeneity of assessments and interventions precluded robust evaluation of clinical implications for telepractice equivalence and the broader area of telepractice efficacy. Future research is needed that will build upon current knowledge through replication. In addition, further evaluation at the impairment and activity limitation/participation restriction levels is needed.

Development of a Weight Loss Mobile App Linked With an Accelerometer for Use in the Clinic: Usability, Acceptability, and Early Testing of its Impact on the Patient-Doctor Relationship

PubMed Central

Choo, Seryung; Jung, Se Young; Kim, Sarah; Kim, Jeong Eun; Han, Jong Soo; Kim, Sohye; Kim, Jeong Hyun; Kim, Jeehye; Kim, Yongseok; Kim, Dongouk; Steinhubl, Steve

2016-01-01

Background Although complications of obesity are well acknowledged and managed by clinicians, management of obesity itself is often difficult, which leads to its underdiagnosis and undertreatment in hospital settings. However, tools that could improve the management of obesity, including self-monitoring, engagement with a social network, and open channels of communication between the patient and doctor, are limited in a clinic-based setting. Objective The objective of our study was to evaluate the usability and acceptability of a newly developed mobile app linked with an accelerometer and its early effects on patient-doctor relationships. Methods From September 2013 to February 2014, we developed a mobile app linked with an accelerometer as a supportive tool for a clinic-based weight loss program. The app used information from electronic health records and delivered tailored educational material. Personal goal setting, as well as monitoring of weight changes and physical activity combined with feedback, are key features of the app. We also incorporated an interactive message board for patients and doctors. During the period of March 2014 to May 2014, we tested our mobile app for 1 month in participants in a hospital clinic setting. We assessed the app’s usability and acceptability, as well as the patient-doctor relationship, via questionnaires and analysis of app usage data. Results We recruited 30 individuals (18 male and 12 female) for the study. The median number of log-ins per day was 1.21, with the most frequently requested item being setting goals, followed by track physical activities and view personal health status. Scales of the depth of the patient-doctor relationship decreased from 27.6 (SD 4.8) to 25.1 (SD 4.5) by a Wilcoxon signed rank test (P=.02). Conclusions A mobile phone app linked with an accelerometer for a clinic-based weight loss program is useful and acceptable for weight management but exhibited less favorable early effects on patient-doctor relationships. PMID:27032541

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

Assessing the effects of changes in care commissioning guidelines at a tertiary centre in London on the provision of NHS-funded procedures of limited clinical effectiveness: an 11-year retrospective database analysis.

PubMed

Rahman, Shafiq; Langridge, Benjamin; Hachach-Haram, Nadine; Hansen, Esther; Bootle, Anna; Bystrzonowski, Nicola; Hamilton, Stephen; Mosahebi, Afshin

2017-07-28

The main objective of this study was to assess the impact of changes in care commissioning policies on National Health Service (NHS)-funded cosmetic procedures over an 11-year period at our centre. The setting was a tertiary care hospital in London regulated by the North Central London Hospitals NHS Trust care commissioning group. We included all patients logged on to our database at the time of the study which was 2087 but later excluded 61 from analysis due to insufficient information. The main outcome measures were the results of tribunal assessment for different cosmetic surgeries which were either accepted, rejected or inconclusive based on the panel meeting. There were a total of 2087 patient requests considered between 2004 and 2015, of which 715 (34%) were accepted, 1311 (63%) were declined and 61 (3%) had inconclusive results. The implementation of local care commissioning guidelines has reduced access to cosmetic surgeries. Within this period, the proportion of procedures accepted has fallen from 36% in 2004 to 21% in 2015 (χ 2 ; p<0.05, 95% CI). Local guidance on procedures of limited clinical effectiveness is a useful, although not evidence-based selection process to reduce access to cosmetic surgery in line with increasing financial constraints. However, patients with a physical impairment may not receive treatment in comparison to previous years, and this can have a negative impact on their quality of life. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

7 CFR 42.143 - Operating Characteristic (OC) curves for on-line sampling and inspection.

Code of Federal Regulations, 2010 CFR

2010-01-01

...=Number of sample units in a subgroup. T=Subgroup tolerance.L=Acceptance limit.S=Starting value. EC02SE91... ng=Number of sample units in a subgroup. T=Subgroup tolerance. L=Acceptance limit. S=Starting value... of sample units in a subgroup. T=Subgroup tolerance. L=Acceptance limit. S=Starting value. EC02SE91...

Psychometric testing of the clinical nurse leader staff satisfaction instrument.

PubMed

Spiva, LeeAnna; Hart, Patricia L; Wesley, Mary Lou; Gallagher, Erin; McVay, Frank; Waggoner, Jessica; Jarrell, Nicole; Threatt, Jamie L

2014-01-01

Patient care is changing rapidly with increased complexity of care, patient volumes, and financial constraints with rising health care costs and limited reimbursements. In response, the clinical nurse leader (CNL) role was developed. No appropriate instrument exists to measure staff satisfaction with the CNL role. This study describes the development and testing of an instrument designed to measure staff satisfaction with implementation of the CNL role. The psychometric properties and factor structure of the Clinical Nurse Leader Staff Satisfaction (CNLSS) instrument was examined. A 2-factor solution was discovered for the CNLSS. Cronbach's alpha coefficients were acceptable for the subscales and instrument. The CNLSS is a valid and reliable instrument. Future research should focus on establishing test-retest reliability and construct validity.

Applying a Conceptual Framework to Maximize the Participation of Diverse Populations in Cancer Clinical Trials

PubMed Central

Napoles, Anna; Cook, Elise; Ginossar, Tamar; Knight, Kendrea D.; Ford, Marvella E.

2017-01-01

The underrepresentation of ethnically diverse populations in cancer clinical trials results in the inequitable distribution of the risks and benefits of this research. Using a case study approach, we apply a conceptual framework of factors associated with the participation of diverse population groups in cancer clinical trials developed by Dr. Jean Ford and colleagues to increase understanding of the specific strategies, and barriers and promoters addressed by these strategies, that resulted in marked success in accrual of racially and ethnically diverse populations in cancer clinical research. Results indicate that the studies presented were able to successfully engage minority participants due to the creation and implementation of multi-level, multifaceted strategies that included: culturally and linguistically appropriate outreach, education, and research studies that were accessible in local communities; infrastructure to support engagement of key stakeholders, clinicians, and organizations serving minority communities; testimonials by ethnically diverse cancer survivors; availability of medical interpretation services; and providing infrastructure that facilitated the engagement in clinical research of clinicians who care for minority patient populations. These strategic efforts were effective in addressing limited awareness of trials, lack of opportunities to participate, and acceptance of engagement in cancer clinical trials. Careful attention to the context and population characteristics in which cancer clinical trials are conducted will be necessary to address disparities in research participation and cancer outcomes. These studies illustrate that progress on minority accrual into clinical research requires intentional efforts to overcome barriers at all three stages of the accrual process: awareness, opportunity and acceptance of participation. PMID:28052822

Just in time? Using QR codes for multi-professional learning in clinical practice.

PubMed

Jamu, Joseph Tawanda; Lowi-Jones, Hannah; Mitchell, Colin

2016-07-01

Clinical guidelines and policies are widely available on the hospital intranet or from the internet, but can be difficult to access at the required time and place. Clinical staff with smartphones could use Quick Response (QR) codes for contemporaneous access to relevant information to support the Just in Time Learning (JIT-L) paradigm. There are several studies that advocate the use of smartphones to enhance learning amongst medical students and junior doctors in UK. However, these participants are already technologically orientated. There are limited studies that explore the use of smartphones in nursing practice. QR Codes were generated for each topic and positioned at relevant locations on a medical ward. Support and training were provided for staff. Website analytics and semi-structured interviews were performed to evaluate the efficacy, acceptability and feasibility of using QR codes to facilitate Just in Time learning. Use was intermittently high but not sustained. Thematic analysis of interviews revealed a positive assessment of the Just in Time learning paradigm and context-sensitive clinical information. However, there were notable barriers to acceptance, including usability of QR codes and appropriateness of smartphone use in a clinical environment. The use of Just in Time learning for education and reference may be beneficial to healthcare professionals. However, alternative methods of access for less technologically literate users and a change in culture of mobile device use in clinical areas may be needed. Copyright © 2016 Elsevier Ltd. All rights reserved.

The user's view of commercially available medical technology

NASA Technical Reports Server (NTRS)

Harrison, D. C.

1975-01-01

The potential user of new medical equipment for imaging the cardiovascular system is often faced with the problem of deciding whether or not to accept a new piece of equipment or a new technological concept into the practice of cardiology. Considerations for acquiring new medical technology are discussed in some detail. Acquisition of new technology should depend on whether the equipment provides more and relevant clinical data, is for research or for limited use, is properly engineered for patient use, presents information in easily storable and retrievable form, is tested and validated clinically, is fabricated by a reliable manufacturer, is cost effective, and may be readily replaced by a new technology.

Reptile cardiology.

PubMed

Mitchell, Mark A

2009-01-01

Cardiovascular disease in reptiles generally is considered an uncommon finding in captive animals, but no large-scale, cross-sectional studies have been performed to determine its prevalence. It is possible that cardiovascular disease is more common than is generally accepted and that the current belief results from limited clinical and diagnostic experience. This article offers guidance drawn from the author's clinical experience and the available literature. It is important that veterinarians pursue a thorough history, physical examination, and diagnostic work-up when managing cardiovascular disease in a reptile case. Veterinarians working with these cases should document their findings and share them with their colleagues to build an evidence-based foundation for reptile medicine.

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

PubMed

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

2017-01-01

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

Evaluating the uptake, acceptability, and effectiveness of Uliza! clinicians' HIV hotline: a telephone consultation service in Kenya.

PubMed

Karari, Charles; Tittle, Robin; Penner, Jeremy; Kulzer, Jayne; Bukusi, Elizabeth A; Marima, Reson; Cohen, Craig R

2011-01-01

Many clinical sites that serve patients who are HIV positive face challenges of insufficient staffing levels and staff training and have limited access to consultation resources including specialists on site. Uliza! (Swahili for "ask") Clinicians' HIV Hotline was launched in April 2006 in Nyanza province in Kenya as a HIV telephone consultation service for healthcare providers. Hotline users called an Uliza! consultant who discussed the patients' problems and helped the caller work through a solution, as well as reinforced national guidelines. This objective of this study was to evaluate the uptake, acceptability, and effectiveness of Uliza! Consultants completed a form with details of each call, and healthcare workers completed satisfaction surveys during site visits. All available medical records were audited to determine whether the advice given by the consultant was implemented. After a year of service, Uliza! responded to 296 calls. Clinical officers (64%) followed by nurses (21%) most frequently used the service. Most callers had questions regarding antiretroviral therapy (36%) or tuberculosis (18%). Thirty-six percent of all consults were pediatric questions. Ninety-four percent of users rated the service as useful. Advice given to providers was implemented and documented in the medical records in 72% of the charts audited. Healthcare providers in HIV clinics will use a telephone consultation service when easily accessible. Clinicians using Uliza! found it useful, and advice given was usually implemented. Uliza! increased access to current information for quality care in a rural and resource limited setting and has potential for scale-up to a national level.

Acceptance of Tinnitus As an Independent Correlate of Tinnitus Severity.

PubMed

Hesser, Hugo; Bånkestad, Ellinor; Andersson, Gerhard

2015-01-01

Tinnitus is the experience of sounds without an identified external source, and for some the experience is associated with significant severity (i.e., perceived negative affect, activity limitation, and participation restriction due to tinnitus). Acceptance of tinnitus has recently been proposed to play an important role in explaining heterogeneity in tinnitus severity. The purpose of the present study was to extend previous investigations of acceptance in relation to tinnitus by examining the unique contribution of acceptance in accounting for tinnitus severity, beyond anxiety and depression symptoms. In a cross-sectional study, 362 participants with tinnitus attending an ENT clinic in Sweden completed a standard set of psychometrically examined measures of acceptance of tinnitus, tinnitus severity, and anxiety and depression symptoms. Participants also completed a background form on which they provided information about the experience of tinnitus (loudness, localization, sound characteristics), other auditory-related problems (hearing problems and sound sensitivity), and personal characteristics. Correlational analyses showed that acceptance was strongly and inversely related to tinnitus severity and anxiety and depression symptoms. Multivariate regression analysis, in which relevant patient characteristics were controlled, revealed that acceptance accounted for unique variance beyond anxiety and depression symptoms. Acceptance accounted for more of the variance than anxiety and depression symptoms combined. In addition, mediation analysis revealed that acceptance of tinnitus mediated the direct association between self-rated loudness and tinnitus severity, even after anxiety and depression symptoms were taken into account. Findings add to the growing body of work, supporting the unique and important role of acceptance in tinnitus severity. The utility of the concept is discussed in relation to the development of new psychological models and interventions for tinnitus severity.

Pilot Testing Behavior Therapy for Chronic Tic Disorders in Neurology and Developmental Pediatrics Clinics.

PubMed

Ricketts, Emily J; Gilbert, Donald L; Zinner, Samuel H; Mink, Jonathan W; Lipps, Tara D; Wiegand, Geoffrey A; Vierhile, Amy E; Ely, Laura J; Piacentini, John; Walkup, John T; Woods, Douglas W

2016-03-01

Comprehensive Behavioral Intervention for Tics (CBIT) is an efficacious treatment with limited regional availability. As neurology and pediatric clinics are often the first point of therapeutic contact for individuals with tics, the present study assessed preliminary treatment response, acceptability, and feasibility of an abbreviated version, modified for child neurology and developmental pediatrics clinics. Fourteen youth (9-17) with Tourette disorder across 2 child neurology clinics and one developmental pediatrics clinic participated in a small case series. Clinician-rated tic severity (Yale Global Tic Severity Scale) decreased from pre- to posttreatment, z = -2.0, P < .05, r = -.48, as did tic-related impairment, z = -2.4, P < .05, r = -.57. Five of the 9 completers (56%) were classified as treatment responders. Satisfaction ratings were high, and therapeutic alliance ratings were moderately high. Results provide guidance for refinement of this modified CBIT protocol. © The Author(s) 2015.

Maternal Support for Human Papillomavirus Vaccination in Honduras

PubMed Central

Langrish, Sarah M.; Cotton, Deborah J.; Simon, Carol J.

2011-01-01

Abstract Background Cervical cancer is a leading cause of cancer death for women in Latin America, and vaccinating against human papillomavirus (HPV) has the potential to limit this disease. We sought to determine Honduran women's awareness of HPV vaccination and interest in vaccinating their daughters against HPV. Methods We interviewed mothers aged ≥17 at primary care clinics in Honduras. First, we collected demographic information and assessed knowledge related to cervical cancer prevention and awareness of HPV and HPV vaccination. Because most participants were not familiar with HPV, education about the relationships among HPV, sexual activity, and cervical cancer was provided before we asked participants if they would accept HPV vaccination for a 9-year-old daughter. We used multivariable logistic regression to determine predictors of vaccine acceptance. Results We interviewed 632 mothers. Only 13% had heard of HPV vaccination before the interview. After education, 91% would accept HPV vaccination for a 9-year-old daughter. Mothers who intended to vaccinate knew more at baseline about cervical cancer prevention than did those who did not endorse vaccination. Demographic characteristics did not predict vaccine acceptance. Conclusions Few Honduran mothers were aware of HPV or HPV vaccination. However, most Honduran mothers would accept HPV vaccination for their daughters after receiving education about the relationship between HPV infection and cervical cancer. Baseline cervical cancer knowledge was associated with vaccine acceptance. PMID:21091226

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.

Discussing Firearm Ownership and Access as Part of Suicide Risk Assessment and Prevention: "Means Safety" versus "Means Restriction".

PubMed

Stanley, Ian H; Hom, Melanie A; Rogers, Megan L; Anestis, Michael D; Joiner, Thomas E

2017-01-01

The goal of this study was to describe the relative utility of the terms "means safety" versus "means restriction" in counseling individuals to limit their access to firearms in the context of a mock suicide risk assessment. Overall, 370 participants were randomized to read a vignette depicting a clinical scenario in which managing firearm ownership and access was discussed either using the term "means safety" or "means restriction." Participants rated the term "means safety" as significantly more acceptable and preferable than "means restriction." Participants randomized to the "means safety" condition reported greater intentions to adhere to clinicians' recommendations to limit access to a firearm for safety purposes (F[1,367] = 7.393, p = .007, [Formula: see text]). The term "means safety" may be more advantageous than "means restriction" when discussing firearm ownership and access in clinical settings and public health-oriented suicide prevention efforts.

Use of Active-Play Video Games to Enhance Aerobic Fitness in Schizophrenia: Feasibility, Safety, and Adherence.

PubMed

Kimhy, David; Khan, Samira; Ayanrouh, Lindsey; Chang, Rachel W; Hansen, Marie C; Lister, Amanda; Ballon, Jacob S; Vakhrusheva, Julia; Armstrong, Hilary F; Bartels, Matthew N; Sloan, Richard P

2016-02-01

Active-play video games have been used to enhance aerobic fitness in various clinical populations, but their use among individuals with schizophrenia has been limited. Feasibility, acceptability, safety, and adherence data were obtained for use of aerobic exercise (AE) equipment by 16 individuals with schizophrenia during a 12-week AE program consisting of three one-hour exercise sessions per week. Equipment included exercise video games for Xbox 360 with Kinect motion sensing devices and traditional exercise equipment. Most participants (81%) completed the training, attending an average of 79% of sessions. The proportion of time spent playing Xbox (39%) exceeded time spent on any other type of equipment. When using Xbox, participants played 2.24±1.59 games per session and reported high acceptability and enjoyment ratings, with no adverse events. Measures of feasibility, acceptability, adherence, and safety support the integration of active-play video games into AE training for people with schizophrenia.

Interobserver variability of radiation therapists aligning to fiducial markers for prostate radiation therapy.

PubMed

Deegan, Timothy; Owen, Rebecca; Holt, Tanya; Roberts, Lisa; Biggs, Jennifer; McCarthy, Alicia; Parfitt, Matthew; Fielding, Andrew

2013-08-01

As the use of fiducial markers (FMs) for the localisation of the prostate during external beam radiation therapy (EBRT) has become part of routine practice, radiation therapists (RTs) have become increasingly responsible for online image interpretation. The aim of this investigation was to quantify the limits of agreement (LoA) between RTs when localising to FMs with orthogonal kilovoltage (kV) imaging. Six patients receiving prostate EBRT utilising FMs were included in this study. Treatment localisation was performed using kV imaging prior to each fraction. Online stereoscopic assessment of FMs, performed by the treating RTs, was compared with the offline assessment by three RTs. Observer agreement was determined by pairwise Bland-Altman analysis. Stereoscopic analysis of 225 image pairs was performed online at the time of treatment, and offline by three RT observers. Eighteen pairwise Bland-Altman analyses were completed to assess the level of agreement between observers. Localisation by RTs was found to be within clinically acceptable 95% LoAs. Small differences between RTs, in both the online and offline setting, were found to be within clinically acceptable limits. RTs were able to make consistent and reliable judgements when matching FMs on planar kV imaging. © 2013 The Authors. Journal of Medical Imaging and Radiation Oncology © 2013 The Royal Australian and New Zealand College of Radiologists.

Population education for young adults: making the small family desirable.

PubMed

Butt, H

1972-01-01

The approach to population control has been almost totally clinical in India so far. A new program of population education which is broader than the clinical appeal is needed. The major target population in India would be illiterates and those with a small amount of education. Within this target population different groups would have to be treated differently. Division would be between illiterates and literates, between urban and rural populations, and between male and female groups. Family planning must be related to other aspects of life, e.g., the health and well-being of the mother and other children in the family. Sex and social education must be presented together. Basic values cannot be changed. Smaller families will eventually change the values. By concentrating on the basic value of survival of the family, the best method to effect this can be shown to be better care of fewer c hildren rather than proliferation of many children. Education should concentrate on the individual and on economic reasons for limiting family size. Once the idea of limiting family size is accepted, it remains to be shown that methods for doing this are available, safe, and religiously and socially acceptable. The message needs constant repetition. Group education would be least expensive. Population education could be presented by incorporating it into other socioeconomic contexts such as reading classes for the illiterates and mathematics classes for the basic literates.

Ethical issues in pediatric oncology phase I-II trials based on a mother's point of view.

PubMed

Oppenheim, D; Geoerger, B; Hartmann, O

2005-11-01

Phase I-II trials are developing in Pediatrics and raise many complex relational, psychological and ethical issues. We present and discuss these based on an interview in a pediatric oncology setting, with a mother who accepted that her daughter be included in such trials and who expressed why she accepted with great sensitivity and profoundness. She explained that after many years of inefficient treatments she had lost all her landmarks and was ready to accept any proposition, even those she would have considered unacceptable earlier. She did not know whether there is a limit to what is acceptable. Her only objective was to gain any time possible in order to continue living with her daughter. She found it important that the research doctor be different from the doctor involved in patient care, and that the latter remains the major decision-maker and correspondent: thus the child's best interests take precedence over that of research. Interviews with the psycho-oncologist can help the parents and the doctors gain a better insight into the various aspects, rational and irrational, conscious and unconscious, involved in the proposition to participate in a clinical trial and in the parents' or the child's acceptance or refusal.

Space Life Sciences at NASA: Spaceflight Health Policy and Standards

NASA Technical Reports Server (NTRS)

Davis, Jeffrey R.; House, Nancy G.

2006-01-01

In January 2005, the President proposed a new initiative, the Vision for Space Exploration. To accomplish the goals within the vision for space exploration, physicians and researchers at Johnson Space Center are establishing spaceflight health standards. These standards include fitness for duty criteria (FFD), permissible exposure limits (PELs), and permissible outcome limits (POLs). POLs delineate an acceptable maximum decrement or change in a physiological or behavioral parameter, as the result of exposure to the space environment. For example cardiovascular fitness for duty standards might be a measurable clinical parameter minimum that allows successful performance of all required duties. An example of a permissible exposure limit for radiation might be the quantifiable limit of exposure over a given length of time (e.g. life time radiation exposure). An example of a permissible outcome limit might be the length of microgravity exposure that would minimize bone loss. The purpose of spaceflight health standards is to promote operational and vehicle design requirements, aid in medical decision making during space missions, and guide the development of countermeasures. Standards will be based on scientific and clinical evidence including research findings, lessons learned from previous space missions, studies conducted in space analog environments, current standards of medical practices, risk management data, and expert recommendations. To focus the research community on the needs for exploration missions, NASA has developed the Bioastronautics Roadmap. The Bioastronautics Roadmap, NASA's approach to identification of risks to human space flight, revised baseline was released in February 2005. This document was reviewed by the Institute of Medicine in November 2004 and the final report was received in October 2005. The roadmap defines the most important research and operational needs that will be used to set policy, standards (define acceptable risk), and implement an overall Risk Management and Analysis process. Currently NASA is drafting spaceflight health standards for neurosensory alterations, space radiation exposure, behavioral health, muscle atrophy, cardiovascular fitness, immunological compromise, bone demineralization, and nutrition.

A New Ethical Challenge for Institutional Review Boards (IRBs)/Ethics Committees (ECs) in the Assessment of Pediatric Clinical Trials

PubMed Central

Rose, Klaus; Kummer, Hans

2015-01-01

Both the US and EU have introduced pediatric pharmaceutical legislation to facilitate clinical trials in children and development of better medicines for children. The first concerns were published in 2014 that the European Medicines Agency (EMA)’s Pediatric Committee (PDCO) may be over-enthusiastic and has compelled questionable pediatric clinical trials from pharmaceutical companies. Numerous clinical trials are mandated in rare conditions for which not enough patients exist for even one trial. Furthermore, where these trials are mandated in adolescent patients, the legal age limit of the 18th birthday is confused with a medical age limit and can result in separate clinical trials in adolescent patients that neither make medical nor scientific sense nor will ever recruit enough patients for a meaningful outcome. To confirm our concerns we searched the registry clinicaltrials.gov and found examples for PDCO-triggered unethical trials. We conclude that such trials should not be accepted by institutional review boards (IRBs)/ethics committees (ECs) and that clinical trials resulting from negotiations with EMA’s PDCO need extra careful scrutiny by IRBs/ECs in order to prevent unethical studies and damage to pediatric research and unnecessary risks to pediatric patients. PMID:27417359

The Kadota Fund International Forum 2004-Clinical group consensus*

PubMed Central

van der Zee, J.; Vujaskovic, Z.; Kondo, M.; Sugahara, T.

2009-01-01

The results from experimental studies indicate that hyperthermia is both an effective complementary treatment to, and a strong sensitiser of, radiotherapy and many cytotoxic drugs. Since the first international hyperthermia conference in 1975, Washington DC, techniques to increase tumour temperature have been developed and tested clinically. Hyperthermia can be applied by several methods: local hyperthermia by external or internal energy sources, perfusion hyperthermia of organs, limbs, or body cavities, and whole body hyperthermia. The clinical value of hyperthermia in combination with other treatment modalities has been shown by randomised trials. Significant improvement in clinical outcome has been demonstrated for tumours of the head and neck, breast, brain, bladder, cervix, rectum, lung, oesophagus, for melanoma and sarcoma. The addition of hyperthermia resulted in remarkably higher (complete) response rates, accompanied by improved local tumour control rates, better palliative effects, and/or better overall survival rates. Toxicity from hyperthermia cannot always be avoided, but is usually of limited clinical relevance. In spite of these good clinical results, hyperthermia has received little attention. Problems with acceptance concern the limited availability of equipment, the lack of awareness concerning clinical results, and the lack of financial resources. In this paper the most relevant literature describing the clinical effects of hyperthermia is reviewed and discussed, and means to overcome the lack of awareness and use of this modality is described. PMID:18283588

Effect of clinically discriminating, evidence-based checklist items on the reliability of scores from an Internal Medicine residency OSCE.

PubMed

Daniels, Vijay J; Bordage, Georges; Gierl, Mark J; Yudkowsky, Rachel

2014-10-01

Objective structured clinical examinations (OSCEs) are used worldwide for summative examinations but often lack acceptable reliability. Research has shown that reliability of scores increases if OSCE checklists for medical students include only clinically relevant items. Also, checklists are often missing evidence-based items that high-achieving learners are more likely to use. The purpose of this study was to determine if limiting checklist items to clinically discriminating items and/or adding missing evidence-based items improved score reliability in an Internal Medicine residency OSCE. Six internists reviewed the traditional checklists of four OSCE stations classifying items as clinically discriminating or non-discriminating. Two independent reviewers augmented checklists with missing evidence-based items. We used generalizability theory to calculate overall reliability of faculty observer checklist scores from 45 first and second-year residents and predict how many 10-item stations would be required to reach a Phi coefficient of 0.8. Removing clinically non-discriminating items from the traditional checklist did not affect the number of stations (15) required to reach a Phi of 0.8 with 10 items. Focusing the checklist on only evidence-based clinically discriminating items increased test score reliability, needing 11 stations instead of 15 to reach 0.8; adding missing evidence-based clinically discriminating items to the traditional checklist modestly improved reliability (needing 14 instead of 15 stations). Checklists composed of evidence-based clinically discriminating items improved the reliability of checklist scores and reduced the number of stations needed for acceptable reliability. Educators should give preference to evidence-based items over non-evidence-based items when developing OSCE checklists.

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.

The process of acceptance among rheumatoid arthritis patients in Switzerland: A qualitative study

PubMed Central

Kostova, Zlatina; Caiata-Zufferey, Maria; Schulz, Peter J

2014-01-01

BACKGROUND: Rheumatoid arthritis (RA) is a chronic, painful disease with many injurious psychological effects. Acceptance is an important component of pain management and is associated with improved quality of life, and lower levels of pain and depression. While studies have begun to identify the stages of acceptance, little is known about factors influencing the ease and speed with which patients pass through these stages. OBJECTIVE: To explore the main stages through which RA patients pass and the strategies they adopt to learn to live with the pain, and to identify factors shaping patients’ capacities to achieve acceptance. METHODS: A qualitative study involving 20 semistructured interviews with RA patients in the Italian-speaking region of Switzerland was conducted. Analysis of the data followed the precepts of grounded theory. RESULTS: Although the present study revealed that acceptance is not a smooth or linear process, five main stages in patients’ struggles to accommodate the newly imposed limitations were, nonetheless, identified: naming the illness; realizing the illness; resisting the illness; ‘hitting the bottom’; and integrating the illness. Diagnosis proved to be an especially tortuous stage in the case of RA, and the effects of delayed diagnosis continued to be felt during the subsequent stages. Patients’ understanding of the notion of acceptance and the strategies that they used to achieve it were also explored. CONCLUSIONS: Diagnosis of RA is notoriously difficult. Beyond the clinical difficulties, structural reasons for late diagnosis (symptoms being neglected by patients and medical professionals) were identifed. Delayed diagnosis hindered the acceptance process throughout, and led to more resistant behaviour and to a struggle to achieve the optimal formula for acceptance – accepting the losses of prepain life while still pursuing personal goals. PMID:24527466

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.

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians.

PubMed

Nappi, Rossella E; Kaunitz, Andrew M; Bitzer, Johannes

2016-01-01

The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices.

Extended regimen combined oral contraception: A review of evolving concepts and acceptance by women and clinicians

PubMed Central

Nappi, Rossella E.; Kaunitz, Andrew M.; Bitzer, Johannes

2016-01-01

ABSTRACT Objectives: The clinical utility of extended regimen combined oral contraceptives (COCs) is increasingly being recognised. Our objective was to understand the attitudes of women and clinicians about the use of these regimens. We present the rationale for extended regimen COCs from a historical perspective, and trace their evolution and growing popularity in light of their clinical benefits. We conclude by offering potential strategies for counselling women about extended regimen COC options. Methods: We conducted a MEDLINE search to identify and summarise studies of extended regimen COCs, focusing on attitudes of women and clinicians regarding efficacy, safety/tolerability and fewer scheduled bleeding episodes and other potential benefits. Results: The body of contemporary literature on extended regimen COCs suggests that their contraceptive efficacy is comparable to that of conventional 28-day (i.e., 21/7) regimens. For women seeking contraception that allows infrequent scheduled bleeding episodes, particularly those who suffer from hormone withdrawal symptoms and cyclical symptoms (e.g., headache, mood changes, dysmenorrhoea, heavy menstrual bleeding), extended regimen COCs are an effective and safe option. Although satisfaction with extended regimen COCs in clinical trials is high, misperceptions about continuous hormone use may still limit the widespread acceptance of this approach. Conclusions: Despite the widespread acceptance among clinicians of extended regimen COCs as an effective and safe contraceptive option, these regimens are underused, likely due to a lack of awareness about their availability and utility among women. Improved patient education and counselling regarding the safety and benefits of extended regimen COCs may help women make more informed contraceptive choices. PMID:26572318

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

PubMed

Bricker, Jonathan B; Mull, Kristin E; Kientz, Julie A; Vilardaga, Roger; Mercer, Laina D; Akioka, Katrina J; Heffner, Jaimee L

2014-10-01

There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

High acceptability for cell phone text messages to improve communication of laboratory results with HIV-infected patients in rural Uganda: a cross-sectional survey study.

PubMed

Siedner, Mark J; Haberer, Jessica E; Bwana, Mwebesa Bosco; Ware, Norma C; Bangsberg, David R

2012-06-21

Patient-provider communication is a major challenge in resource-limited settings with large catchment areas. Though mobile phone usership increased 20-fold in Africa over the past decade, little is known about acceptability of, perceptions about disclosure and confidentiality, and preferences for cell phone communication of health information in the region. We performed structured interviews of fifty patients at the Immune Suppression Syndrome clinic in Mbarara, Uganda to assess four domains of health-related communication: a) cell phone use practices and literacy, b) preferences for laboratory results communication, c) privacy and confidentiality, and d) acceptability of and preferences for text messaging to notify patients of abnormal test results. Participants had a median of 38 years, were 56% female, and were residents of a large catchment area throughout southwestern Uganda. All participants expressed interest in a service to receive information about laboratory results by cell phone text message, stating benefits of increased awareness of their health and decreased transportation costs. Ninety percent reported that they would not be concerned for unintended disclosure. A minority additionally expressed concerns about difficulty interpreting messages, discouragement upon learning bad news, and technical issues. Though all respondents expressed interest in password protection of messages, there was also a strong desire for direct messages to limit misinterpretation of information. Cell phone text messaging for communication of abnormal laboratory results is highly acceptable in this cohort of HIV-infected patients in rural Uganda. The feasibility of text messaging, including an optimal balance between privacy and comprehension, should be further studied.

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.

Outcome quality standards in pancreatic oncologic surgery in Spain.

PubMed

Sabater, Luis; Mora, Isabel; Gámez Del Castillo, Juan Manuel; Escrig-Sos, Javier; Muñoz-Forner, Elena; Garcés-Albir, Marina; Dorcaratto, Dimitri; Ortega, Joaquín

2018-05-18

To establish quality standards in oncologic surgery is a complex but necessary challenge to improve surgical outcomes. Unlike other tumors, there are no well-defined quality standards in pancreatic cancer. The aim of this study is to identify quality indicators in pancreatic oncologic surgery in Spain as well as their acceptable limits of variability. Quality indicators were selected based on clinical practice guidelines, consensus conferences, reviews and national publications on oncologic pancreatic surgery between the years 2000 and 2016. Variability margins for each indicator have been determined by statistical process control techniques and graphically represented with the 99.8 and 95% confidence intervals above and below the weighted average according to sample size. The following indicators have been determined with their weighted average and acceptable quality limits: resectability rate 71% (>58%), morbidity 58% (<73%), mortality 4% (<10%), biliary leak 6% (<14%), pancreatic fistula rate 18% (<29%), hemorrhage 11% (<21%), reoperation rate 11% (<20%) and mean hospital stay (<21 days). To date, few related series have been published, and they present important methodological limitations. Among the selected indicators, the morbidity and mortality quality limits have come out higher than those obtained in international standards. It is necessary for Spanish pancreatic surgeons to adopt homogeneous criteria regarding indicators and their definitions to allow for the comparison of their results. Copyright © 2018 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Evidence-based alternatives for autogenous grafts around teeth: outcomes, attachment, and stability.

PubMed

McGuire, Michael K

2014-06-01

Although the use of autogenous harvested tissues has proven to be the gold standard for soft tissue augmentation procedures involving root coverage or generation of keratinized tissue, harvest site morbidity and limited supply have prompted clinicians to seek graft alternatives. Using a hierarchy of evidence, the author reviews both clinical and patient-reported results for harvest graft substitutes and, considering his own research experience, reviews autogenous graft substitute outcomes, attachment, and stability over time. Overall, when the goal is keratinized-tissue generation, living cellular constructs and xenogeneic collagen matrices have provided acceptable clinical results, but with better esthetics and patient preference than autogenous free gingival grafts. For root coverage therapy, enamel matrix derivatives, platelet-derived growth factors, and xenogeneic collagen matrices have provided acceptable results with equivalent esthetics to autogenous connective tissue grafts, while also being preferred by patients. Longterm results for enamel matrix derivatives, platelet-derived growth factors, and xenogeneic collagen matrices indicate root coverage can be maintained over time. In the author's hands, xenogeneic collagen matrices have been the only harvest graft alternatives that can be used either covered or uncovered by soft tissue.

Videoconferencing for a veteran's pain management follow-up clinic.

PubMed

Elliott, Janette; Chapman, Judith; Clark, David J

2007-03-01

The under treatment of pain has been well documented. Contributing to this is the limited availability of pain management specialists in many geographic areas. The use of technology to provide care to underserved areas is gaining momentum. We chose to study whether stable patients and staff in chronic pain clinic were satified with the use of a videoconferencing format in care delivery. Our goals were to determine whether patients and staff could successfully operate the extant videoconferencing equipment, was the equipment dependably functional, was the use of a videoconferencing format an acceptable method of healthcare delivery for both patients and staff, whether patients and staff were satisfied with the process, and whether this was a cost-effective mode of care delivery. Thirty-six patients were enrolled over 29 months. Questionnaires were administered to staff and patients. Routine pain clinic patient assessment tools were administered. Results showed the use of videoconferencing for this group of patients is useable and satisfactory for both patients and staff, that the patients save time and money, and that for a system where videoconferencing equipment is already in use, it is also cost effective. Staff were able to identify new patient problems. Some patients would prefer to be seen in person but find that the savings in time and money override this preference. Hearing impaired patients have difficulty using this medium. Dependable equipment and phone connections are needed. A videoconferencing clinic format is a clinically acceptable and cost effective method for follow-up of stable patients with chronic pain.

Feasibility and acceptability of a computer-based tool to improve contraceptive counseling.

PubMed

Wilson, Ellen K; Krieger, Kathleen E; Koo, Helen P; Minnis, Alexandra M; Treiman, Katherine

2014-07-01

The objective was to test the feasibility and acceptability of a computerized tool, Smart Choices, designed to enhance the quality of contraceptive counseling in family planning clinics. The tool includes (a) a questionnaire completed by patients and summarized in a printout for providers and (b) a birth control guide patients explore to learn about various contraceptive methods. In 2 family planning clinics, we conducted interviews with 125 women who used the Smart Choices computerized tool and 7 providers. Smart Choices integrated into clinic flow well in one clinic, but less well in the other, which had very short waiting times. Patients were generally enthusiastic about Smart Choices, including its helpfulness in preparing them and their providers for the counseling session and increasing their knowledge of contraceptive methods. Providers varied in how much they used the printout and in their opinions about its usefulness. Some felt its usefulness was limited because it overlapped with the clinic's intake forms or because it did not match with their concept of counseling needs. Others felt it provided valuable information not collected by intake forms and more honest information. Some found Smart Choices to be most helpful with patients who were unsure what method they wanted. Smart Choices is feasible to implement and well received by patients, but modifications are needed to increase provider enthusiasm for this tool. The Smart Choices tool requires refinement before widespread dissemination. Copyright © 2014 Elsevier Inc. All rights reserved.

Aversion to injection limits acceptability of extended-release naltrexone among homeless, alcohol-dependent patients.

PubMed

Friedmann, Peter D; Mello, Dawn; Lonergan, Sean; Bourgault, Claire; O'Toole, Thomas P

2013-01-01

Ending homelessness is a major priority of the Department of Veteran Affairs (VA), and alcohol use can be a barrier to stable housing. Clinical trials suggest that depot extended-release naltrexone (XR-NTX) is efficacious in reducing alcohol consumption among alcohol-dependent subjects. An open-label, randomized pilot study sought to examine the feasibility and effectiveness of XR-NTX versus oral naltrexone to improve alcohol consumption and housing stability among homeless, alcohol-dependent veterans at the Providence Veteran Affairs Medical Center. Of 215 potential candidates approached over a 16-month recruitment period, only 15 agreed to consider study entry and 7 were randomized. The primary reasons given for refusal were not wanting an injection; fear of needles; and not wanting to change drinking habits. Only 1 participant in the XR-NTX group returned after the first injection. Three participants in the oral naltrexone group attended all 7 visits and had good outcomes. Although XR-NTX has demonstrated efficacy in reducing heavy drinking, limited acceptance of the injection might reduce its effectiveness among homeless, alcohol-dependent patients.

10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

Code of Federal Regulations, 2013 CFR

2013-01-01

... acceptable for processing, the Director of New Reactors or the Director of Nuclear Reactor Regulation will... 10 Energy 1 2013-01-01 2013-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION AGENCY RULES OF PRACTICE AND PROCEDURE...

Clinical, aetiological, anatomical and pathological classification (CEAP): gold standard and limits.

PubMed

Rabe, E; Pannier, F

2012-03-01

The first CEAP (clinical, aetiological, anatomical and pathological elements) consensus document was published after a consensus conference of the American Venous Forum, held at the sixth annual meeting of the AVF in February 1994 in Maui, Hawaii. In the following years the CEAP classification was published in many international journals and books which has led to widespread international use of the CEAP classification since 1995. The aim of this paper is to review the benefits and limits of CEAP from the available literature. In an actual Medline analysis with the keywords 'CEAP' and 'venous insufficiency', 266 publications using the CEAP classification in venous diseases are available. The CEAP classification was accepted in the venous community and used in scientific publications, but in most of the cases only the clinical classification was used. Limitations of the first version including a lack of clear definition of clinical signs led to a revised version. The CEAP classification is the gold standard of classification of chronic venous disorders today. Nevertheless for proper use some facts have to be taken into account: the CEAP classification is not a severity classification, C2 summarizes all kinds of varicose veins, in C3 it may be difficult to separate venous and other reasons for oedema, and corona phlebectatica is not included in the classification. Further revisions of the CEAP classification may help to overcome the still-existing deficits.

The Clinical Relevance of Maintaining the Functional Integrity of the Stratum Corneum in both Healthy and Disease-affected Skin

PubMed Central

Del Rosso, James Q.; Levin, Jacqueline

2011-01-01

It has been recognized for approximately 50 years that the stratum corneum exhibits biological properties that contribute directly to maintaining and sustaining healthy skin. Continued basic science and clinical research coupled with keen clinical observation has led to more recent recognition and general acceptance that the stratum corneum completes many vital “barrier” tasks, including but not limited to regulating epidermal water content and the magnitude of water loss; mitigating exogenous oxidants that can damage components of skin via an innate antioxidant system; preventing or limiting cutaneous infection via multiple antimicrobial peptides; responding via innate immune mechanisms to “cutaneous invaders” of many origins, including microbes, true allergens, and other antigens; and protecting its neighboring cutaneous cells and structures that lie beneath from damaging effects of ultraviolet radiation. Additionally, specific abnormalities of the stratum corneum are associated with the clinical expression of certain disease states. This article provides a thorough “primer” for the clinician, reviewing the multiple normal homeostatic functions of the stratum corneum and the cutaneous challenges that arise when individual functions of this thin yet very active epidermal layer are compromised by exogenous and/or endogenous factors. PMID:21938268

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.

Bench-to-bedside review: the importance of the precision of the reference technique in method comparison studies--with specific reference to the measurement of cardiac output.

PubMed

Cecconi, Maurizio; Rhodes, Andrew; Poloniecki, Jan; Della Rocca, Giorgio; Grounds, R Michael

2009-01-01

Bland-Altman analysis is used for assessing agreement between two measurements of the same clinical variable. In the field of cardiac output monitoring, its results, in terms of bias and limits of agreement, are often difficult to interpret, leading clinicians to use a cutoff of 30% in the percentage error in order to decide whether a new technique may be considered a good alternative. This percentage error of +/- 30% arises from the assumption that the commonly used reference technique, intermittent thermodilution, has a precision of +/- 20% or less. The combination of two precisions of +/- 20% equates to a total error of +/- 28.3%, which is commonly rounded up to +/- 30%. Thus, finding a percentage error of less than +/- 30% should equate to the new tested technique having an error similar to the reference, which therefore should be acceptable. In a worked example in this paper, we discuss the limitations of this approach, in particular in regard to the situation in which the reference technique may be either more or less precise than would normally be expected. This can lead to inappropriate conclusions being drawn from data acquired in validation studies of new monitoring technologies. We conclude that it is not acceptable to present comparison studies quoting percentage error as an acceptability criteria without reporting the precision of the reference technique.

Comparability of Mayo-Portland Adaptability Inventory ratings by staff, significant others and people with acquired brain injury.

PubMed

Malec, James F

2004-06-01

To determine the internal consistency, reliability and comparability of the Mayo-Portland Adaptability Inventory (MPAI-4) and sub-scales completed by people with acquired brain injury (ABI), family and significant others (SO) and rehabilitation staff. 134 people with ABI consecutively seen for outpatient rehabilitation evaluation. MPAI-4 protocols based on independent ratings by the people with ABI undergoing evaluation, SO and rehabilitation staff were submitted to Rasch Facets analysis to determine the internal consistency of the overall measure and sub-scales (Ability, Adjustment and Participation indices) for each rater group and for a composite measure based on all rater groups. Rater agreement for individual items was also examined. Rasch indicators of internal consistency were entirely within acceptable limits for 3-rater composite full scale and sub-scale measures; these indicators were generally within acceptable limits for measures based on a single rater group. Item agreement was generally acceptable; disagreements suggested various sources of bias for specific rater groups. The MPAI-4 possesses satisfactory internal consistency regardless of rating source. A composite measure based on ratings made independently by people with ABI, SO and staff may serve as a 'gold standard' for research purposes. In the clinical setting, assessment of varying perspectives and biases may not only best represent outcome as evaluated by all parties involved but be essential to developing effective rehabilitation plans.

Patient attitudes about the clinical use of placebo: qualitative perspectives from a telephone survey.

PubMed

Ortiz, Robin; Chandros Hull, Sara; Colloca, Luana

2016-04-04

To examine qualitative responses regarding the use of placebo treatments in medical care in a sample of US patients.Survey studies suggest a deliberate clinical use of placebos by physicians, and prior research has found that although most US patients find placebo use acceptable, the rationale for these beliefs is largely unknown. Members of the Outpatient Clinic at the Kaiser Permanente Northern California interviewed research participants who had been seen for a chronic health problem at least once in the prior 6 months. 853 women (61%) and men, white (58%) and non-white participants aged 18-75 years. Qualitative responses on perceptions of placebo use from one-time telephone surveys were analysed for common themes and associations with demographic variables. Prior results indicated that a majority of respondents felt it acceptable for doctors to recommend placebo treatments. Our study found that a lack of harm (n=291, 46.1%) and potential benefit (n=250, 39.6%) were the most common themes to justify acceptability of placebo use. Responses citing potential benefit were associated with higher education (r=0.787; p<0.024). Of the minority of respondents who judged it never acceptable for doctors to recommend placebo treatments, the most often referenced rationale was obligation of the doctor to do more (n=102, 48.3%). Additional themes emerged around the issue of whether a doctor was transparent about placebo use, including honesty, patient's right to know and power of the mind. Older age was associated with likelihood to cite overall physician, as opposed to treatment, related themes (r=0.753; p<0.002). Participants seem to appreciate and understand the lack of harm and potential benefit associated with placebo treatments, while valuing the role of the physician and the patient in its implementation. 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/

Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers' Perspectives on Testing, Training and Quality Assurance.

PubMed

Ansbro, Éimhín M; Gill, Michelle M; Reynolds, Joanna; Shelley, Katharine D; Strasser, Susan; Sripipatana, Tabitha; Tshaka Ncube, Alexander; Tembo Mumba, Grace; Terris-Prestholt, Fern; Peeling, Rosanna W; Mabey, David

2015-01-01

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues.

Introduction of Syphilis Point-of-Care Tests, from Pilot Study to National Programme Implementation in Zambia: A Qualitative Study of Healthcare Workers’ Perspectives on Testing, Training and Quality Assurance

PubMed Central

Ansbro, Éimhín M.; Gill, Michelle M.; Reynolds, Joanna; Shelley, Katharine D.; Strasser, Susan; Sripipatana, Tabitha; Ncube, Alexander Tshaka; Tembo Mumba, Grace; Terris-Prestholt, Fern; Peeling, Rosanna W.; Mabey, David

2015-01-01

Syphilis affects 1.4 million pregnant women globally each year. Maternal syphilis causes congenital syphilis in over half of affected pregnancies, leading to early foetal loss, pregnancy complications, stillbirth and neonatal death. Syphilis is under-diagnosed in pregnant women. Point-of-care rapid syphilis tests (RST) allow for same-day treatment and address logistical barriers to testing encountered with standard Rapid Plasma Reagin testing. Recent literature emphasises successful introduction of new health technologies requires healthcare worker (HCW) acceptance, effective training, quality monitoring and robust health systems. Following a successful pilot, the Zambian Ministry of Health (MoH) adopted RST into policy, integrating them into prevention of mother-to-child transmission of HIV clinics in four underserved Zambian districts. We compare HCW experiences, including challenges encountered in scaling up from a highly supported NGO-led pilot to a large-scale MoH-led national programme. Questionnaires were administered through structured interviews of 16 HCWs in two pilot districts and 24 HCWs in two different rollout districts. Supplementary data were gathered via stakeholder interviews, clinic registers and supervisory visits. Using a conceptual framework adapted from health technology literature, we explored RST acceptance and usability. Quantitative data were analysed using descriptive statistics. Key themes in qualitative data were explored using template analysis. Overall, HCWs accepted RST as learnable, suitable, effective tools to improve antenatal services, which were usable in diverse clinical settings. Changes in training, supervision and quality monitoring models between pilot and rollout may have influenced rollout HCW acceptance and compromised testing quality. While quality monitoring was integrated into national policy and training, implementation was limited during rollout despite financial support and mentorship. We illustrate that new health technology pilot research can rapidly translate into policy change and scale-up. However, training, supervision and quality assurance models should be reviewed and strengthened as rollout of the Zambian RST programme continues. PMID:26030741

Mycobacterium tuberculosis and whole genome sequencing: a practical guide and online tools available for the clinical microbiologist.

PubMed

Satta, G; Atzeni, A; McHugh, T D

2017-02-01

Whole genome sequencing (WGS) has the potential to revolutionize the diagnosis of Mycobacterium tuberculosis infection but the lack of bioinformatic expertise among clinical microbiologists is a barrier for adoption. Software products for analysis should be simple, free of charge, able to accept data directly from the sequencer (FASTQ files) and to provide the basic functionalities all-in-one. The main aim of this narrative review is to provide a practical guide for the clinical microbiologist, with little or no practical experience of WGS analysis, with a specific focus on software products tailor-made for M. tuberculosis analysis. With sequencing performed by an external provider, it is now feasible to implement WGS analysis in the routine clinical practice of any microbiology laboratory, with the potential to detect resistance weeks before traditional phenotypic culture methods, but the clinical microbiologist should be aware of the limitations of this approach. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. Published by Elsevier Ltd. All rights reserved.

[Conceptual foundation of the operational diagnostic approach in psychiatry].

PubMed

Jäger, M; Strauss, A; Frasch, K; Becker, T

2007-08-01

Based on the pioneering work of Emil Kraepelin, Karl Jaspers, Kurt Schneider and representatives of logical empiricism, the basic principles of the operational diagnostic approach in psychiatry are described. Operational diagnostic systems like ICD-10 and DSM-IV aimed at a standardisation of psychiatric language which can be accepted by different schools in psychiatry. However, ICD-10 and DSM-IV should not be misinterpreted as "nosology" because they do not reflect a specific model of psychiatric diseases. The advantages of operational diagnostic systems as instruments for communication in a clinical and scientific context are limited by the fact that they disregard the subjective psychopathology. This dimension, however, deserves attention in clinic and research.

Augmented reality in neurosurgery

PubMed Central

Tagaytayan, Raniel; Kelemen, Arpad

2016-01-01

Neurosurgery is a medical specialty that relies heavily on imaging. The use of computed tomography and magnetic resonance images during preoperative planning and intraoperative surgical navigation is vital to the success of the surgery and positive patient outcome. Augmented reality application in neurosurgery has the potential to revolutionize and change the way neurosurgeons plan and perform surgical procedures in the future. Augmented reality technology is currently commercially available for neurosurgery for simulation and training. However, the use of augmented reality in the clinical setting is still in its infancy. Researchers are now testing augmented reality system prototypes to determine and address the barriers and limitations of the technology before it can be widely accepted and used in the clinical setting. PMID:29765445

Augmented reality in neurosurgery.

PubMed

Tagaytayan, Raniel; Kelemen, Arpad; Sik-Lanyi, Cecilia

2018-04-01

Neurosurgery is a medical specialty that relies heavily on imaging. The use of computed tomography and magnetic resonance images during preoperative planning and intraoperative surgical navigation is vital to the success of the surgery and positive patient outcome. Augmented reality application in neurosurgery has the potential to revolutionize and change the way neurosurgeons plan and perform surgical procedures in the future. Augmented reality technology is currently commercially available for neurosurgery for simulation and training. However, the use of augmented reality in the clinical setting is still in its infancy. Researchers are now testing augmented reality system prototypes to determine and address the barriers and limitations of the technology before it can be widely accepted and used in the clinical setting.

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…

Optimising treatment resources for OCD: a review of the evidence base for technology-enhanced delivery.

PubMed

Lovell, Karina; Bee, Penny

2011-12-01

Obsessive-compulsive disorder (OCD) is a chronic and disabling mental health problem. Only a minority of people receive evidence-based psychological treatments, and this deficit has prompted an increasing focus on delivering cognitive behaviour therapy (CBT) in new and innovative ways. To conduct a scoping review of the published evidence base for CBT-based interventions incorporating a health technology in the treatment of OCD. The questions posed by the review were (a) are technology-assisted treatments clinically effective, (b) are patient outcomes durable and (c) are more innovative services deemed acceptable by those individuals who engage in them? Scoping review of published studies using any study design examining CBT interventions incorporating a health technology for OCD. Electronic databases searched included MEDLINE (1966-2010), PsycInfo (1967-2010), EMBASE (1980-2010) and CINAHL databases (1982-2010). Thirteen studies were identified, of these, five used bibliotherapy, five examined computerised CBT (cCBT), two investigated telephone delivered CBT and one evaluated video conferencing. Overall studies were small and methodologically flawed, which precludes definitive conclusions of clinical effectiveness, durability or stakeholder satisfaction. To date the evidence base for technology-enhanced OCD treatments has undergone limited development. Future research should seek to overcome the methodological shortcomings of published work by conducting large-scale trials that incorporate clinical, cost and acceptability outcomes.

The use and QA of biologically related models for treatment planning: short report of the TG-166 of the therapy physics committee of the AAPM.

PubMed

Allen Li, X; Alber, Markus; Deasy, Joseph O; Jackson, Andrew; Ken Jee, Kyung-Wook; Marks, Lawrence B; Martel, Mary K; Mayo, Charles; Moiseenko, Vitali; Nahum, Alan E; Niemierko, Andrzej; Semenenko, Vladimir A; Yorke, Ellen D

2012-03-01

Treatment planning tools that use biologically related models for plan optimization and/or evaluation are being introduced for clinical use. A variety of dose-response models and quantities along with a series of organ-specific model parameters are included in these tools. However, due to various limitations, such as the limitations of models and available model parameters, the incomplete understanding of dose responses, and the inadequate clinical data, the use of biologically based treatment planning system (BBTPS) represents a paradigm shift and can be potentially dangerous. There will be a steep learning curve for most planners. The purpose of this task group is to address some of these relevant issues before the use of BBTPS becomes widely spread. In this report, the authors (1) discuss strategies, limitations, conditions, and cautions for using biologically based models and parameters in clinical treatment planning; (2) demonstrate the practical use of the three most commonly used commercially available BBTPS and potential dosimetric differences between biologically model based and dose-volume based treatment plan optimization and evaluation; (3) identify the desirable features and future directions in developing BBTPS; and (4) provide general guidelines and methodology for the acceptance testing, commissioning, and routine quality assurance (QA) of BBTPS.

Relationships between dispositional mindfulness, self-acceptance, perceived stress, and psychological symptoms in advanced gastrointestinal cancer patients.

PubMed

Xu, Wei; Zhou, Yuyang; Fu, Zhongfang; Rodriguez, Marcus

2017-12-01

Previous studies have shown that dispositional mindfulness is associated with less psychological symptoms in cancer patients. The present study investigated how dispositional mindfulness is related to psychological symptoms in advanced gastrointestinal cancer patients by considering the roles of self-acceptance and perceived stress. A total of 176 patients with advanced gastrointestinal cancer were recruited to complete a series of questionnaires including Mindfulness Attention Awareness Scale, Self-acceptance Questionnaire, Chinese Perceived Stress Scale, and General Health Questionnaire. Results showed that the proposed model fitted the data very well (χ 2  = 7.564, df = 7, P = .364, χ 2 /df = 1.094, Goodness of Fit Index (GFI) = 0.986, Comparative Fit Index (CFI) = 0.998, Tucker Lewis Index (TLI) = 0.995, Root Mean Square Error of Approximation (RMSEA) = 0.023). Further analyses revealed that, self-acceptance and perceived stress mediated the relation between dispositional mindfulness and psychological symptoms (indirect effect = -0.052, 95% confidence interval = -0.087 ~ -0.024), while self-acceptance also mediated the relation between dispositional mindfulness and perceived stress (indirect effect = -0.154, 95% confidence interval = -0.261 ~ -0.079). Self-acceptance and perceived stress played critical roles in the relation between dispositional mindfulness and psychological symptoms. Limitations, clinical implications, and directions for future research were discussed. Copyright © 2017 John Wiley & Sons, Ltd.

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.

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…

Dual Kidney Transplantation: A Review of Past and Prospect for Future.

PubMed

Khalil, Muhammad Abdul Mabood; Tan, Jackson; Khan, Taqi F Toufeeq; Khalil, Muhammad Ashhad Ullah; Azmat, Rabeea

2017-01-01

Kidney transplantation (KT) is one of the treatment options for patients with chronic kidney disease. The number of patients waiting for kidney transplantation is growing day by day. Various strategies have been put in place to expand the donor pool. Extended criteria donors are now accepted more frequently. Increasing number of elderly donors with age > 60 years, history of diabetes or hypertension, and clinical proteinuria are accepted as donor. Dual kidney transplantation (DKT) is also more frequently done and experience with this technique is slowly building up. DKT not only helps to reduce the number of patients on waiting list but also limits unnecessary discard of viable organs. Surgical complications of DKT are comparable to single kidney transplantation (SKT). Patient and graft survivals are also promising. This review article provides a summary of evidence available in the literature.

Dual Kidney Transplantation: A Review of Past and Prospect for Future

PubMed Central

Khan, Taqi F. Toufeeq; Khalil, Muhammad Ashhad Ullah; Azmat, Rabeea

2017-01-01

Kidney transplantation (KT) is one of the treatment options for patients with chronic kidney disease. The number of patients waiting for kidney transplantation is growing day by day. Various strategies have been put in place to expand the donor pool. Extended criteria donors are now accepted more frequently. Increasing number of elderly donors with age > 60 years, history of diabetes or hypertension, and clinical proteinuria are accepted as donor. Dual kidney transplantation (DKT) is also more frequently done and experience with this technique is slowly building up. DKT not only helps to reduce the number of patients on waiting list but also limits unnecessary discard of viable organs. Surgical complications of DKT are comparable to single kidney transplantation (SKT). Patient and graft survivals are also promising. This review article provides a summary of evidence available in the literature. PMID:28752128

10 CFR 2.643 - Acceptance and docketing of application for limited work authorization.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 1 2010-01-01 2010-01-01 false Acceptance and docketing of application for limited work authorization. 2.643 Section 2.643 Energy NUCLEAR REGULATORY COMMISSION RULES OF PRACTICE FOR DOMESTIC LICENSING... Construct Certain Utilization Facilities; and Advance Issuance of Limited Work Authorizations Phased...

The Usability and Acceptability of an Adolescent mHealth HIV/STI and Drug Abuse Preventive Intervention in Primary Care.

PubMed

Cordova, David; Alers-Rojas, Francheska; Lua, Frania Mendoza; Bauermeister, Jose; Nurenberg, Rachel; Ovadje, Lauretta; Fessler, Kathryn; Delva, Jorge; Salas-Wright, Christopher P; Council, Youth Leadership

2018-01-01

Human Immunodeficiency Virus (HIV)/sexually transmitted infection (STI) risk behaviors among adolescents remain significant public health concerns. Shifts in policy and advances in technology provide opportunities for researchers and clinicians to deliver and evaluate mobile-health (mHealth) prevention programs in primary care, however, research is limited. This study assessed the usability and acceptability of Storytelling 4 Empowerment-a mHealth HIV/STI and drug abuse preventive intervention app-among adolescents in primary care. Informed by principles of community-based participatory research, we recruited a purposive sample of 30 adolescents from a youth-centered community health care clinic in Southeast Michigan. The study sample is primarily African American and female. Adolescents who participated in the Storytelling 4 Empowerment intervention assessed its usability and acceptability, and self-reported their HIV/STI risk behaviors. We used a multiple-methods approach. Adolescents reported high acceptability of the content, process, and format of Storytelling 4 Empowerment, as evidenced by qualitative data and mean scores from the Session Evaluation Form for the HIV/STI and Alcohol/Drug content, overall Storytelling 4 Empowerment intervention, and Client Satisfaction Questionnaire-8. Findings indicate that Storytelling 4 Empowerment is acceptable among adolescents in primary care. A next step is to examine the effect of Storytelling 4 Empowerment on adolescent sexual risk and drug use behaviors and HIV/STI testing.

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 Trial Design for HIV Prevention Research: Determining Standards of Prevention.

PubMed

Dawson, Liza; Zwerski, Sheryl

2015-06-01

This article seeks to advance ethical dialogue on choosing standards of prevention in clinical trials testing improved biomedical prevention methods for HIV. The stakes in this area of research are high, given the continued high rates of infection in many countries and the budget limitations that have constrained efforts to expand treatment for all who are currently HIV-infected. New prevention methods are still needed; at the same time, some existing prevention and treatment interventions have been proven effective but are not yet widely available in the countries where they most urgently needed. The ethical tensions in this field of clinical research are well known and have been the subject of extensive debate. There is no single clinical trial design that can optimize all the ethically important goals and commitments involved in research. Several recent articles have described the current ethical difficulties in designing HIV prevention trials, especially in resource limited settings; however, there is no consensus on how to handle clinical trial design decisions, and existing international ethical guidelines offer conflicting advice. This article acknowledges these deep ethical dilemmas and moves beyond a simple descriptive approach to advance an organized method for considering what clinical trial designs will be ethically acceptable for HIV prevention trials, balancing the relevant criteria and providing justification for specific design decisions. Published 2014. This article is a U.S. Government work and is in the public domain in the USA.

Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: a systematic review

PubMed Central

2014-01-01

Background Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury. Methods Study Design: Systematic review. The review protocol was registered through PROSPERO (CRD42012002069). Electronic databases (PubMed, MEDLINE, EMBASE, CINAHL) were searched up to 19th of June 2013 to identify diagnostic studies comparing the accuracy of clinical tests for ACL injury to an acceptable reference standard (arthroscopy, arthrotomy, or MRI). Risk of bias was appraised using the QUADAS-2 checklist. Index test accuracy was evaluated using a descriptive analysis of paired likelihood ratios and displayed as forest plots. Results A total of 285 full-text articles were assessed for eligibility, from which 14 studies were included in this review. Included studies were deemed to be clinically and statistically heterogeneous, so a meta-analysis was not performed. Nine clinical tests from the history (popping sound at time of injury, giving way, effusion, pain, ability to continue activity) and four from physical examination (anterior draw test, Lachman’s test, prone Lachman’s test and pivot shift test) were investigated for diagnostic accuracy. Inspection of positive and negative likelihood ratios indicated that none of the individual tests provide useful diagnostic information in a clinical setting. Most studies were at risk of bias and reported imprecise estimates of diagnostic accuracy. Conclusion Despite being widely used and accepted in clinical practice, the results of individual history items or physical tests do not meaningfully change the probability of ACL injury. In contrast combinations of tests have higher diagnostic accuracy; however the most accurate combination of clinical tests remains an area for future research. Clinical relevance Clinicians should be aware of the limitations associated with the use of clinical tests for diagnosis of ACL injury. PMID:25187877

Are blind people more likely to accept free cataract surgery? A study of vision-related quality of life and visual acuity in Kenya.

PubMed

Briesen, Sebastian; Roberts, Helen; Ilako, Dunera; Karimurio, Jefitha; Courtright, Paul

2010-01-01

To determine possible differences in visual acuity, socio-demographic factors and vision-related Quality of Life (QoL) between people accepting and people refusing sponsored cataract surgery. Three hundred and fifty seven local residents with visually impairing cataract, presenting at screening sites in Kwale District, Kenya were clinically assessed and interviewed. The World Health Organization (WHO) QoL-questionnaire WHO/Prevention of Blindness and Deafness Visual Functioning Questionnaire 20 (PBD-VFQ20) was used to determine the vision-related QoL. A standardized questionnaire asked for socio-demographic data and prior cataract surgery in one eye. After interview, patients were offered free surgery. Primary outcome was the mean QoL-score between acceptors and non-acceptors. Secondary outcomes were visual acuity and socio-demographic factors and their contribution to QoL-scores and the decision on acceptance or refusal. Fifty nine people (16.5%) refused and 298 accepted cataract surgery. Vision-related QoL was poorer in people accepting than in those refusing (mean score 51.54 and 43.12 respectively). People with poor visual acuity were only slightly more likely to accept surgery than people with better vision; the strongest predictors of acceptance were the QoL-score and gender. Men were twice as likely to accept compared to women. Of people who accepted surgery, 73.8% had best eye vision of 20/200 or better. In this population, visual acuity was of limited use to predict a person's decision to accept or refuse cataract surgery. QoL-scores provide further insight into which individuals will agree to surgery and it might be useful to adapt the QoL-questions for field use. Gender inequities remain a matter of concern with men being more likely to get sight-restoring surgery.

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.

Moms growing together: Piloting action methods and expressive arts in a therapeutic group for teen mothers.

PubMed

SmithBattle, Lee; Chantamit-O-Pas, Chutima; Freed, Patricia; McLaughlin, Dorcas; Schneider, Joanne K

2017-05-01

The purpose of this pilot study was to test the safety, acceptability, feasibility, and effectiveness of Moms Growing Together (MGT), an intervention to prevent and reduce psychological distress in teen mothers. A mixed method design was used. The primary outcomes were reported satisfaction with MGT (acceptance); successful recruitment and retention of teen mothers (feasibility); and prevention or reduction of psychological distress (safety and effectiveness). Summary scores on each of three symptom measures operationally defined psychological distress. Sixteen African-American teen mothers participated in the study: eight in MGT and eight in a comparison group. MGT was considered safe and acceptable. MGT had a negative small effect (effect size [ES] = -0.028) on decreasing depression in participants and a moderate effect in reducing anxiety (ES = 0.395) and trauma symptoms (ES = 0.521-0.554) relative to the comparison group. Prolonged recruitment limited feasibility. Because psychological distress casts a long shadow on teen mothers' well-being, developing teen-friendly clinical programs that address their mental health is a high priority. © 2017 Wiley Periodicals, Inc.

Diagnosing anaemia in pregnancy in rural clinics: assessing the potential of the Haemoglobin Colour Scale.

PubMed Central

van den Broek, N. R.; Ntonya, C.; Mhango, E.; White, S. A.

1999-01-01

Anaemia in pregnancy is a common and severe problem in many developing countries. Because of lack of resources and staff motivation, screening for anaemia is often solely by clinical examination of the conjunctiva or is not carried out at all. A new colour scale for the estimation of haemoglobin concentration has been developed by WHO. The present study compares the results obtained using the new colour scale on 729 women visiting rural antenatal clinics in Malawi with those obtained by HemoCue haemoglobinometer and electronic Coulter Counter and with the assessment of anaemia by clinical examination of the conjunctiva. Sensitivity using the colour scale was consistently better than for conjunctival inspection alone and interobserver agreement and agreement with Coulter Counter measurements was good. The Haemoglobin Colour Scale is simple to use, well accepted, cheap and gives immediate results. It shows considerable potential for use in screening for anaemia in antenatal clinics in settings where resources are limited. PMID:10063656

Diagnosing anaemia in pregnancy in rural clinics: assessing the potential of the Haemoglobin Colour Scale.

PubMed

van den Broek, N R; Ntonya, C; Mhango, E; White, S A

1999-01-01

Anaemia in pregnancy is a common and severe problem in many developing countries. Because of lack of resources and staff motivation, screening for anaemia is often solely by clinical examination of the conjunctiva or is not carried out at all. A new colour scale for the estimation of haemoglobin concentration has been developed by WHO. The present study compares the results obtained using the new colour scale on 729 women visiting rural antenatal clinics in Malawi with those obtained by HemoCue haemoglobinometer and electronic Coulter Counter and with the assessment of anaemia by clinical examination of the conjunctiva. Sensitivity using the colour scale was consistently better than for conjunctival inspection alone and interobserver agreement and agreement with Coulter Counter measurements was good. The Haemoglobin Colour Scale is simple to use, well accepted, cheap and gives immediate results. It shows considerable potential for use in screening for anaemia in antenatal clinics in settings where resources are limited.

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.

Subarachnoid haemorrhage guidelines and clinical practice: a cross-sectional study of emergency department consultants' and neurospecialists' views and risk tolerances.

PubMed

Lansley, J; Selai, C; Krishnan, A S; Lobotesis, K; Jäger, H R

2016-09-15

To establish if emergency medicine and neuroscience specialist consultants have different risk tolerances for investigation of suspected spontaneous subarachnoid haemorrhage (SAH), and to establish if their risk-benefit appraisals concur with current guidelines. 4 major neuroscience centres in London. 58 consultants in emergency medicine and neuroscience specialities (neurology, neurosurgery and neuroradiology) participated in an anonymous survey. The primary outcome measure was the highest stated acceptable risk of missing SAH in the neurologically intact patient presenting with sudden onset headache. Secondary outcome measures included agreement with guideline recommendations, risk/benefit appraisal and required performance of diagnostic tests, including lumbar puncture. Emergency department clinicians accepted almost 3 times the risk of a missed SAH diagnosis compared with the neuroscience specialists (2.8% vs 1.1%; p=0.02), were more likely to accept a higher risk of missed diagnosis for the benefit of a non-invasive test (p=0.04) and were more likely to disagree with current published guidelines stipulating the need for LP in all CT-negative cases (p=0.001). Divergence from recognised procedures for SAH investigation is often criticised and attributed to a lack of knowledge of guidelines. This study indicates that divergence from guidelines may be explained by alternative risk-benefit appraisals made by doctors with their patients. Guideline recommendations may gain wider acceptance if they accommodate the requirements of the doctors and patients using them. Further study of clinical risk tolerance may help explain patterns of diagnostic test use and other variations in healthcare delivery. 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/

Employment-based reinforcement of adherence to an FDA approved extended release formulation of naltrexone in opioid-dependent adults: a randomized controlled trial.

PubMed

DeFulio, Anthony; Everly, Jeffrey J; Leoutsakos, Jeannie-Marie S; Umbricht, Annie; Fingerhood, Michael; Bigelow, George E; Silverman, Kenneth

2012-01-01

Naltrexone provides excellent opioid blockade, but its clinical utility is limited because opioid-dependent patients typically refuse it. An injectable suspension of naltrexone for extended release (XR-NTX) was recently approved by the FDA for treatment of opioid dependence. XR-NTX treatment may require concurrent behavioral intervention to maximize adherence and effectiveness, thus we sought to evaluate employment-based reinforcement as a method of improving adherence to XR-NTX in opiate dependent adults. Opioid-dependent adults (n=38) were detoxified and inducted onto oral naltrexone, then randomly assigned to contingency or prescription conditions. Participants received up to six doses of XR-NTX at four-week intervals. All participants could earn vouchers for attendance and performance at a therapeutic workplace. Contingency participants were required to accept XR-NTX injections to access the workplace and earn vouchers. Prescription participants could earn vouchers independent of their acceptance of XR-NTX injections. Contingency participants accepted significantly more naltrexone injections than prescription participants (87% versus 52%, p=.002), and were more likely to accept all injections (74% versus 26%, p=.004). Participants in the two conditions provided similar percentages of samples negative for opiates (72% versus 65%) and for cocaine (58% versus 54%). Opiate positivity was significantly more likely when samples were also cocaine positive, independent of naltrexone blockade (p=.002). Long-term adherence to XR-NTX in unemployed opiate dependent adults is low under usual care conditions. Employment-based reinforcement can maintain adherence to XR-NTX. Ongoing cocaine use appears to interfere with the clinical effectiveness of XR-NTX on opiate use. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

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.

High acceptability for cell phone text messages to improve communication of laboratory results with HIV-infected patients in rural Uganda: a cross-sectional survey study

PubMed Central

2012-01-01

Background Patient-provider communication is a major challenge in resource-limited settings with large catchment areas. Though mobile phone usership increased 20-fold in Africa over the past decade, little is known about acceptability of, perceptions about disclosure and confidentiality, and preferences for cell phone communication of health information in the region. Methods We performed structured interviews of fifty patients at the Immune Suppression Syndrome clinic in Mbarara, Uganda to assess four domains of health-related communication: a) cell phone use practices and literacy, b) preferences for laboratory results communication, c) privacy and confidentiality, and d) acceptability of and preferences for text messaging to notify patients of abnormal test results. Results Participants had a median of 38 years, were 56% female, and were residents of a large catchment area throughout southwestern Uganda. All participants expressed interest in a service to receive information about laboratory results by cell phone text message, stating benefits of increased awareness of their health and decreased transportation costs. Ninety percent reported that they would not be concerned for unintended disclosure. A minority additionally expressed concerns about difficulty interpreting messages, discouragement upon learning bad news, and technical issues. Though all respondents expressed interest in password protection of messages, there was also a strong desire for direct messages to limit misinterpretation of information. Conclusions Cell phone text messaging for communication of abnormal laboratory results is highly acceptable in this cohort of HIV-infected patients in rural Uganda. The feasibility of text messaging, including an optimal balance between privacy and comprehension, should be further studied. PMID:22720901

Umbilical cord blood banks. Ethical aspects. Public versus private banks.

PubMed

Aznar Lucea, Justo

2012-01-01

The creation of umbilical cord blood (UCB) banks raises interesting medical, social, economic and ethical issues. This paper reviews the ethical problems specifically. In this respect, it evaluates: a) whether there are advantages to the use of UCB compared to bone marrow, b) whether or not it is ethical to create UCB banks, c) whether their creation is ethically acceptable in terms of their clinical usefulness or d) the use made of them for therapeutic purposes, and finally e) whether their creation is ethically justified from a cost/profitability point of view. We focus primarily on evaluating the ethical controversy between public and private banks, particularly on whether it is ethical to bank autologous blood in private UCB banks, on the basis of its limited possibilities for use by the cord blood donor. We can conclude that, from an ethical point of view, autologous blood banks have limited acceptance among specialised researchers, scientific societies and other public institutions. Therefore, we believe that it is ethically more acceptable to support the creation of public UCB banks for medical and social reasons and, above all, based on the principle of justice and human solidarity. Nevertheless, there is no definitive ethical argument why a couple, according to their autonomy and freedom, cannot bank their child's UCB in a private bank. An equally acceptable solution could be the creation of mixed banks, such as that proposed by the Virgin Health Bank or like the Spanish system where autologous samples can be stored in public banks but with the proviso that if at any time the stored sample is required by any person other than the donor, it would have to be given to them.

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.

Are photographic records reliable for orthodontic screening?

PubMed

Mandall, N A

2002-06-01

The aim of the study was to evaluate the reliability of a panel of orthodontists for accepting new patient referrals based on clinical photographs. Eight orthodontists from Greater Manchester, Lancashire, Chester, and Derbyshire observed clinical photographs of 40 consecutive new patients attending the orthodontic department, Hope Hospital, Salford. They recorded whether or not they would accept the patient, as a new patient referral, in their department. Each consultant was asked to take into account factors, such as oral hygiene, dental development, and severity of the malocclusion. Kappa statistic for multiple-rater agreement and kappa statistic for intra-observer reliability were calculated. Inter-observer panel agreement for accepting new patient referrals based on photographic information was low (multiple rater kappa score 0.37). Intra-examiner agreement was better (kappa range 0.34-0.90). Clinician agreement for screening and accepting orthodontic referrals based on clinical photographs is comparable to that previously reported for other clinical decision making.

[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.

iPad experience during clinical rotations from seven medical schools in the United States: Lessons learned.

PubMed

Deutsch, Kalie; Gaines, Julie K; Hill, Janette R; Nuss, Michelle A

2016-11-01

Since 2010, many US medical schools have introduced the use of mobile technology into their curriculum. Preclinical use of mobile technologies has been well studied, but use in the clinical years has been less explored. Our objective was to identify the clinical uses and limitations of mobile technology in the clinical curriculum. Interviews were conducted with key personnel at seven U. S. medical schools who introduced iPad programs during the clinical years. Interviews were qualitatively analyzed using a constant comparison technique. Eight "best practices" for introducing mobile technology in the clinical years were identified: (1) plan before implementation, (2) define focused goals, (3) establish a tablet "culture," (4) recruit appropriate implementation team, (5) invest in training, (6) involve students in mentoring, (7) accept variable use, and (8) encourage innovation. There is growing interest in using mobile technology for teaching and learning in the clinical curriculum. Following the identified best practices may assist schools with the integration of the technology into the curriculum and better prepare medical students to handle the increasing use of technology.

Accuracy of clinical tests in the diagnosis of anterior cruciate ligament injury: a systematic review.

PubMed

Swain, Michael S; Henschke, Nicholas; Kamper, Steven J; Downie, Aron S; Koes, Bart W; Maher, Chris G

2014-01-01

Numerous clinical tests are used in the diagnosis of anterior cruciate ligament (ACL) injury but their accuracy is unclear. The purpose of this study is to evaluate the diagnostic accuracy of clinical tests for the diagnosis of ACL injury. Systematic review. The review protocol was registered through PROSPERO (CRD42012002069). Electronic databases (PubMed, MEDLINE, EMBASE, CINAHL) were searched up to 19th of June 2013 to identify diagnostic studies comparing the accuracy of clinical tests for ACL injury to an acceptable reference standard (arthroscopy, arthrotomy, or MRI). Risk of bias was appraised using the QUADAS-2 checklist. Index test accuracy was evaluated using a descriptive analysis of paired likelihood ratios and displayed as forest plots. A total of 285 full-text articles were assessed for eligibility, from which 14 studies were included in this review. Included studies were deemed to be clinically and statistically heterogeneous, so a meta-analysis was not performed. Nine clinical tests from the history (popping sound at time of injury, giving way, effusion, pain, ability to continue activity) and four from physical examination (anterior draw test, Lachman's test, prone Lachman's test and pivot shift test) were investigated for diagnostic accuracy. Inspection of positive and negative likelihood ratios indicated that none of the individual tests provide useful diagnostic information in a clinical setting. Most studies were at risk of bias and reported imprecise estimates of diagnostic accuracy. Despite being widely used and accepted in clinical practice, the results of individual history items or physical tests do not meaningfully change the probability of ACL injury. In contrast combinations of tests have higher diagnostic accuracy; however the most accurate combination of clinical tests remains an area for future research. Clinicians should be aware of the limitations associated with the use of clinical tests for diagnosis of ACL injury.

Home Videophones Improve Direct Observation in Tuberculosis Treatment: A Mixed Methods Evaluation

PubMed Central

Wade, Victoria A.; Karnon, Jonathan; Eliott, Jaklin A.; Hiller, Janet E.

2012-01-01

Background The use of direct observation to monitor tuberculosis treatment is controversial: cost, practical difficulties, and lack of patient acceptability limit effectiveness. Telehealth is a promising alternative delivery method for improving implementation. This study aimed to evaluate the clinical and cost-effectiveness of a telehealth service delivering direct observation, compared to an in-person drive-around service. Methodology/Principal Findings The study was conducted within a community nursing service in South Australia. Telehealth patients received daily video calls at home on a desktop videophone provided by the nursing call center. A retrospective cohort study assessed the effectiveness of the telehealth and traditional forms of observation, defined by the proportion of missed observations recorded in case notes. This data was inputted to a model, estimating the incremental cost-effectiveness ratio (ICER) of telehealth. Semi-structured interviews were conducted with current patients, community nursing and Chest Clinic staff, concerning service acceptability, usability and sustainability. The percentage of missed observations for the telehealth service was 12.1 (n = 58), compared to 31.1 for the in-person service (n = 70). Most of the difference of 18.9% (95% CI: 12.2 – 25.4) was due to fewer pre-arranged absences. The economic analysis calculated the ICER to be AUD$1.32 (95% CI: $0.51 – $2.26) per extra day of successful observation. The video service used less staff time, and became dominant if implemented on a larger scale and/or with decreased technology costs. Qualitative analysis found enabling factors of flexible timing, high patient acceptance, staff efficiency, and Chest Clinic support. Substantial technical problems were manageable, and improved liaison between the nursing service and Chest Clinic was an unexpected side-benefit. Conclusions/Significance Home video observation is a patient-centered, resource efficient way of delivering direct observation for TB, and is cost-effective when compared with a drive-around service. Future research is recommended to determine applicability and effectiveness in other settings. PMID:23226243

Interaction of 308-nm excimer laser light with temporomandibular joint related structures

NASA Astrophysics Data System (ADS)

Liesenhoff, Tim; Funk, Armin

1994-02-01

Arthroscopy of TMJ has become a clinically important and more and more accepted method for diagnosis and treatment of TMJ alteration. This minimal invasive method is clearly limited by the anatomical dimensions of the TMJ. A 308 nm excimer laserlight has already found clinical applications in angioplasty, ophthalmology, and dentistry. The aim of the presented study was to find out if it is possible to ablate TMJ related structures under arthroscopic conditions. It also aims to evaluate the energy-threshold for ablation and the maximal possible rate of ablation. Contrary to other laser systems it offers a unique combination of minimal tissue alteration, precise tissue ablation guidability through optical fibers, and a good transmission through water.

Implementation of an electronic fingerprint-linked data collection system: a feasibility and acceptability study among Zambian female sex workers.

PubMed

Wall, Kristin M; Kilembe, William; Inambao, Mubiana; Chen, Yi No; Mchoongo, Mwaka; Kimaru, Linda; Hammond, Yuna Tiffany; Sharkey, Tyronza; Malama, Kalonde; Fulton, T Roice; Tran, Alex; Halumamba, Hanzunga; Anderson, Sarah; Kishore, Nishant; Sarwar, Shawn; Finnegan, Trisha; Mark, David; Allen, Susan A

2015-06-27

Patient identification within and between health services is an operational challenge in many resource-limited settings. When following HIV risk groups for service provision and in the context of vaccine trials, patient misidentification can harm patient care and bias trial outcomes. Electronic fingerprinting has been proposed to identify patients over time and link patient data between health services. The objective of this study was to determine 1) the feasibility of implementing an electronic-fingerprint linked data capture system in Zambia and 2) the acceptability of this system among a key HIV risk group: female sex workers (FSWs). Working with Biometrac, a US-based company providing biometric-linked healthcare platforms, an electronic fingerprint-linked data capture system was developed for use by field recruiters among Zambian FSWs. We evaluated the technical feasibility of the system for use in the field in Zambia and conducted a pilot study to determine the acceptability of the system, as well as barriers to uptake, among FSWs. We found that implementation of an electronic fingerprint-linked patient tracking and data collection system was feasible in this relatively resource-limited setting (false fingerprint matching rate of 1/1000 and false rejection rate of <1/10,000) and was acceptable among FSWs in a clinic setting (2% refusals). However, our data indicate that less than half of FSWs are comfortable providing an electronic fingerprint when recruited while they are working. The most common reasons cited for not providing a fingerprint (lack of privacy/confidentiality issues while at work, typically at bars or lodges) could be addressed by recruiting women during less busy hours, in their own homes, in the presence of "Queen Mothers" (FSW organizers), or in the presence of a FSW that has already been fingerprinted. Our findings have major implications for key population research and improved health services provision. However, more work needs to be done to increase the acceptability of the electronic fingerprint-linked data capture system during field recruitment. This study indicated several potential avenues that will be explored to increase acceptability.

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.

Evaluation of the acceptability and usability of a decision support system to encourage safe and effective use of opioid therapy for chronic, noncancer pain by primary care providers.

PubMed

Trafton, Jodie; Martins, Susana; Michel, Martha; Lewis, Eleanor; Wang, Dan; Combs, Ann; Scates, Naquell; Tu, Samson; Goldstein, Mary K

2010-04-01

To develop and evaluate a clinical decision support system (CDSS) named Assessment and Treatment in Healthcare: Evidenced-Based Automation (ATHENA)-Opioid Therapy, which encourages safe and effective use of opioid therapy for chronic, noncancer pain. CDSS development and iterative evaluation using the analysis, design, development, implementation, and evaluation process including simulation-based and in-clinic assessments of usability for providers followed by targeted system revisions. Volunteers provided detailed feedback to guide improvements in the graphical user interface, and content and design changes to increase clinical usefulness, understandability, clinical workflow fit, and ease of completing guideline recommended practices. Revisions based on feedback increased CDSS usability ratings over time. Practice concerns outside the scope of the CDSS were also identified. Usability testing optimized the CDSS to better address barriers such as lack of provider education, confusion in dosing calculations and titration schedules, access to relevant patient information, provider discontinuity, documentation, and access to validated assessment tools. It also highlighted barriers to good clinical practice that are difficult to address with CDSS technology in its current conceptualization. For example, clinicians indicated that constraints on time and competing priorities in primary care, discomfort in patient-provider communications, and lack of evidence to guide opioid prescribing decisions impeded their ability to provide effective, guideline-adherent pain management. Iterative testing was essential for designing a highly usable and acceptable CDSS; however, identified barriers may limit the impact of the ATHENA-Opioid Therapy system and other CDSS on clinical practices and outcomes unless CDSS are paired with parallel initiatives to address these issues.

Whole lung lavage with intermittent double lung ventilation. A modified technique for managing pulmonary alveolar proteinosis.

PubMed

Ahmed, Raees; Iqbal, Mobeen; Kashef, Sayed H; Almomatten, Mohammed I

2005-01-01

Whole lung lavage is still the most effective treatment for pulmonary alveolar proteinosis. We report a 21-year-old male diagnosed with pulmonary alveolar proteinosis by open lung biopsy and who underwent whole lung lavage with a modified technique. He showed significant improvement in clinical and functional parameters. The technique of intermittent double lung ventilation during lavage procedure keeps the oxygen saturation in acceptable limits in patients at risk for severe hypoxemia and allows the procedure to be completed in a single setting.

Monitoring mental health treatment acceptance and initial treatment adherence in veterans: veterans of Operations Enduring Freedom and Iraqi Freedom versus other veterans of other eras.

PubMed

Lindley, Steven; Cacciapaglia, Holly; Noronha, Delilah; Carlson, Eve; Schatzberg, Alan

2010-10-01

Identifying factors that influence mental health outcomes in veterans can aid in the redesign of programs to maximize the likelihood of early resolution of problems. To that end, we examined demographic and clinical process data from 2,684 veterans who scored positive on a mental health screen. We investigated this data set for patterns and possible predictors of mental health referral acceptance and attendance. The majority of patients had not received mental health treatment within the last two years (76%). Veterans of Operations Enduring Freedom and Iraqi Freedom (OEF/OIF) were more likely to accept a mental health referral for depression but were equally likely to attend a mental health visit as other era veterans. Decreased acceptance was associated with provider type and contact method, clinic location, depression only, and specific age ranges (65-74). Among those who accepted a referral, decreased attendance was associated with clinic location, depression only, and retirement. No variables predicted OEF/OIF acceptance/attendance. In conclusion, our findings illustrate the importance of close, continual monitoring of clinical process data to help reveal targets for improving mental health care for veterans. © 2010 Association for Research in Nervous and Mental Disease.

Use of IRIS image-enhancement facilities on digital images by radiologists during a clinical trial at the Ottawa Civic Hospital

NASA Astrophysics Data System (ADS)

Coristine, Marjorie; Goldberg, Morris; Beeton, Carolyn; Dillon, Richard F.; Tombaugh, Jo W.; Belanger, Garry; Ahuja, J.

1990-07-01

The Integrated Radiological Information System (IRIS) supports the capture and distribution of digitized x-ray images and voice reports in the form of " electronic" patient folders which can be accessed at physician workstations throughout the hospital. Each workstation has an image screen to display documents and x-ray images a control screen to access patient folders and a hands-free telephone to dictate and play back reports and enable consultation between radiologist and clinician workstations. A seven week clinical trial of IRIS was conducted at the Ottawa Civic Hospital during April and May 1989. The system operated to process cases from the Department of Emergency Medicine weekday afternoons. Observers recorded for each case how radiologists used the system. After the trial radiologists participated in an extensive debriefing interview during which they were asked to complete a number of rating scales addressing the following issues: 1) willingness to diagnose by tissue type and by type of pathology 2) seriousness of problems due to system limitations 3) the perceived usefulness of enhancement capabilities and measurement tools. Overall the system was found to be acceptable by the radiologists. There was some concern about diagnosis in soft tissue regions. Most of the system features were regarded as acceptable but there were areas which needed improvement. The suggested improvements are described where applicable. The enhancement facilities and the means of using the facilities were acceptable overall. 426 /

20 CFR 404.780 - Evidence of “good cause” for exceeding time limits on accepting proof of support or application...

Code of Federal Regulations, 2010 CFR

2010-04-01

... accepting proof of support or application for a lump-sum death payment. (a) When evidence of good cause is... death payment. You may be asked for evidence of good cause for these delays if— (1) You are the insured... limits on accepting proof of support or application for a lump-sum death payment. 404.780 Section 404.780...

WE-AB-207B-01: Dose Tolerance for SBRT/SABR

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

Grimm, J

Purpose: Stereotactic body radiation therapy (SBRT) / stereotactic ablative body radiotherapy (SABR) is gaining popularity, but quantitative dose tolerance has still been lacking. To improve this, the April 2016 issue of Seminars in Radiation Oncology will have normal tissue complication probability (NTCP) models for 10 critical structures: optic pathway, cochlea, oral mucosa, esophagus, chestwall, aorta, bronchi, duodenum, small bowel, and spinal cord. Methods: The project included more than 1500 treatments in 1–5 fractions using CyberKnife, Gamma Knife, or LINAC, with 60 authors from 15 institutions. NTCP models were constructed from the 97 grade 2–3 complications, predominantly scored using the commonmore » terminology criteria for adverse events (CTCAEv4). Dose volume histogram (DVH) data from each institutional dataset was loaded into the DVH Evaluator software (DiversiLabs, LLC, Huntingdon Valley, Pa) for modeling. The current state of the literature for the critical structures was depicted using DVH Risk Maps: comparative graphs of dose tolerance limits that can include estimated risk levels, reported complications, DVH data for study patients, as well as high- and low-risk dose tolerance limits. Results: For relatively acceptable toxicity like grade 1–3 rib fractures and chestwall pain, the high-risk limits have 50% risk and the low-risk limits have 5% risk. Emami et al (IJROBP 1991 May 15;21(1):109–22) used 50% and 5% risk levels for all structures, whereas this effort used clinically acceptable ranges for each: in structures like aorta or spinal cord where complications must be avoided, the high- and low-risk limits have about 3% and 1% risk, respectively, in this issue of Seminars. These statistically based guidelines can help ensure plan quality for each patient. Conclusion: NTCP for SBRT is now becoming available. Hypofractionated dose tolerance can be dramatically different than extrapolations of conventional fractionation so NTCP analysis of the SBRT/SBRT data is important to ensure safe clinical practice. Dr. Grimm, designed and holds intellectual property rights to the DVH Evaluator software tool which is an FDA-cleared product in commercial use, and was used to analyze the data.« less

Assessment of patient-reported symptoms of anxiety

PubMed Central

Rose, Matthias; Devine, Janine

2014-01-01

Patient self-reported symptoms are of crucial importance to identify anxiety disorders, as well as to monitor their treatment in clinical practice and research. Thus, for evidence-based medicine, a precise, reliable, and valid (ie, “objective”) assessment of the patient's reported “subjective” symptoms is warranted. There is a plethora of instruments available, which can provide psychometrically sound assessments of anxiety, but there are several limitations of current tools that need to be carefully considered for their successful use. Nevertheless, the empirical assessment of mental health status is not as accepted in medicine as is the assessment of biomarkers. One reason for this may be that different instruments assessing the same psychological construct use different scales. In this paper we present some new developments that promise to provide one common metric for the assessment of anxiety, to facilitate the general acceptance of mental health assessments in the future. PMID:25152658

Development and testing of two lifestyle interventions for persons with chronic mild-to-moderate traumatic brain injury: Acceptability and feasibility.

PubMed

Bay, Esther; Ribbens-Grimm, Christine; Chan, Roxane R

2016-05-01

This clinical methods discursive highlights the development, piloting, and evaluation of two group interventions designed for persons who experienced chronic traumatic brain injury (TBI). Intervention science for this population is limited and lacking in rigor. Our innovative approach to customize existing interventions and develop parallel delivery methods guided by Allostatic Load theory is presented and preliminary results described. Overall, parallel group interventions delivered by trained leaders with mental health expertise were acceptable and feasible for persons who reported being depressed, stressed, and symptomatic. They reported being satisfied with the overall programs and mostly satisfied with the individual classes. Attendance was over the anticipated 70% expected rate and changes in daily living habits were reported by participants. These two group interventions show promise in helping persons to self manage their chronic stress and symptomatology. Copyright © 2015 Elsevier Inc. All rights reserved.

Department of Defense picture archiving and communication system acceptance testing: results and identification of problem components.

PubMed

Allison, Scott A; Sweet, Clifford F; Beall, Douglas P; Lewis, Thomas E; Monroe, Thomas

2005-09-01

The PACS implementation process is complicated requiring a tremendous amount of time, resources, and planning. The Department of Defense (DOD) has significant experience in developing and refining PACS acceptance testing (AT) protocols that assure contract compliance, clinical safety, and functionality. The DOD's AT experience under the initial Medical Diagnostic Imaging Support System contract led to the current Digital Imaging Network-Picture Archiving and Communications Systems (DIN-PACS) contract AT protocol. To identify the most common system and component deficiencies under the current DIN-PACS AT protocol, 14 tri-service sites were evaluated during 1998-2000. Sixteen system deficiency citations with 154 separate types of limitations were noted with problems involving the workstation, interfaces, and the Radiology Information System comprising more than 50% of the citations. Larger PACS deployments were associated with a higher number of deficiencies. The most commonly cited systems deficiencies were among the most expensive components of the PACS.

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.

End points for adjuvant therapy trials: has the time come to accept disease-free survival as a surrogate end point for overall survival?

PubMed

Gill, Sharlene; Sargent, Daniel

2006-06-01

The intent of adjuvant therapy is to eradicate micro-metastatic residual disease following curative resection with the goal of preventing or delaying recurrence. The time-honored standard for demonstrating efficacy of new adjuvant therapies is an improvement in overall survival (OS). This typically requires phase III trials of large sample size with lengthy follow-up. With the intent of reducing the cost and time of completing such trials, there is considerable interest in developing alternative or surrogate end points. A surrogate end point may be employed as a substitute to directly assess the effects of an intervention on an already accepted clinical end point such as mortality. When used judiciously, surrogate end points can accelerate the evaluation of new therapies, resulting in the more timely dissemination of effective therapies to patients. The current review provides a perspective on the suitability and validity of disease-free survival (DFS) as an alternative end point for OS. Criteria for establishing surrogacy and the advantages and limitations associated with the use of DFS as a primary end point in adjuvant clinical trials and as the basis for approval of new adjuvant therapies are discussed.

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.

Clinical consequences and economic costs of untreated obstructive sleep apnea syndrome.

PubMed

Knauert, Melissa; Naik, Sreelatha; Gillespie, M Boyd; Kryger, Meir

2015-09-01

To provide an overview of the healthcare and societal consequences and costs of untreated obstructive sleep apnea syndrome. PubMed database for English-language studies with no start date restrictions and with an end date of September 2014. A comprehensive literature review was performed to identify all studies that discussed the physiologic, clinical and societal consequences of obstructive sleep apnea syndrome as well as the costs associated with these consequences. There were 106 studies that formed the basis of this analysis. Undiagnosed and untreated obstructive sleep apnea syndrome can lead to abnormal physiology that can have serious implications including increased cardiovascular disease, stroke, metabolic disease, excessive daytime sleepiness, work-place errors, traffic accidents and death. These consequences result in significant economic burden. Both, the health and societal consequences and their costs can be decreased with identification and treatment of sleep apnea. Treatment of obstructive sleep apnea syndrome, despite its consequences, is limited by lack of diagnosis, poor patient acceptance, lack of access to effective therapies, and lack of a variety of effective therapies. Newer modes of therapy that are effective, cost efficient and more accepted by patients need to be developed.

Evaluation of marginal gap of Ni-Cr copings made with conventional and accelerated casting techniques.

PubMed

Tannamala, Pavan Kumar; Azhagarasan, Nagarasampatti Sivaprakasam; Shankar, K Chitra

2013-01-01

Conventional casting techniques following the manufacturers' recommendations are time consuming. Accelerated casting techniques have been reported, but their accuracy with base metal alloys has not been adequately studied. We measured the vertical marginal gap of nickel-chromium copings made by conventional and accelerated casting techniques and determined the clinical acceptability of the cast copings in this study. Experimental design, in vitro study, lab settings. Ten copings each were cast by conventional and accelerated casting techniques. All copings were identical, only their mold preparation schedules differed. Microscopic measurements were recorded at ×80 magnification on the perpendicular to the axial wall at four predetermined sites. The marginal gap values were evaluated by paired t test. The mean marginal gap by conventional technique (34.02 μm) is approximately 10 μm lesser than that of accelerated casting technique (44.62 μm). As the P value is less than 0.0001, there is highly significant difference between the two techniques with regard to vertical marginal gap. The accelerated casting technique is time saving and the marginal gap measured was within the clinically acceptable limits and could be an alternative to time-consuming conventional techniques.

Teaching Translational Research to Medical Students: The New York University School of Medicine's Master's of Science in Clinical Investigation Dual-Degree Program.

PubMed

Gillman, Jennifer; Pillinger, Michael; Plottel, Claudia S; Galeano, Claudia; Maddalo, Scott; Hochman, Judith S; Cronstein, Bruce N; Gold-von Simson, Gabrielle

2015-12-01

To develop the next generation of translational investigators, New York University School of Medicine (NYUSOM) and the NYU-NYC Health and Hospitals Corporation Clinical and Translational Science Institute (NYU-HHC CTSI) developed the Master's of Science in Clinical Investigation dual-degree (MD/MSCI) program. This 5-year program dedicates 1 year to coursework and biomedical research, followed by a medical school/research overlap year, to prepare students for academic research careers. This paper details the MD/MSCI program's curriculum and approach to mentorship, describes the research/professional interests of students, and reports student productivity. In the first 4 years of the program (2010-2014) 20 students were matriculated; 7 (35%) were women, and 12 (60%) research projects were in surgical specialties. To date, 14 students have applied to residency, and half pursued surgical residency programs. Our students have produced 68 accepted abstracts, 15 abstracts in submission, 38 accepted papers, and 24 papers in submission. Despite the time-limited nature of this program, additional training in research design and implementation has promoted a high level of productivity. We conclude that dual-degree training in medicine and translational research is feasible for medical students and allows for meaningful participation in valuable projects. Follow-up is warranted to evaluate the academic trajectory of these students. © 2015 Wiley Periodicals, Inc.

Classifying orofacial pains: a new proposal of taxonomy based on ontology

PubMed Central

NIXDORF, D. R.; DRANGSHOLT, M. T.; ETTLIN, D. A.; GAUL, C.; DE LEEUW, R.; SVENSSON, P.; ZAKRZEWSKA, J. M.; DE LAAT, A.; CEUSTERS, W.

2012-01-01

SUMMARY Propose a new taxonomy model based on ontological principles for disorders that manifest themselves through the symptom of persistent orofacial pain and are commonly seen in clinical practice and difficult to manage. Consensus meeting of eight experts from various geographic areas representing different perspectives (orofacial pain, headache, oral medicine and ontology) as an initial step towards improving the taxonomy. Ontological principles were introduced, reviewed and applied during the consensus building process. Diagnostic criteria for persistent dento-alveolar pain disorder (PDAP) were formulated as an example to be used to model the taxonomical structure of all orofacial pain conditions. These criteria have the advantage of being (i) anatomically defined, (ii) in accordance with other classification systems for the provision of clinical care, (iii) descriptive and succinct, (iv) easy to adapt for applications in varying settings, (v) scalable and (vi) transferable for the description of pain disorders in other orofacial regions of interest. Limitations are that the criteria introduce new terminology, do not have widespread acceptance and have yet to be tested. These results were presented to the greater conference membership and were unanimously accepted. Consensus for the diagnostic criteria of PDAP was established within this working group. This is an initial first step towards developing a coherent taxonomy for orofacial pain disorders, which is needed to improve clinical research and care. PMID:21848527

Teaching Translational Research to Medical Students: The New York University School of Medicine's Master's of Science in Clinical Investigation Dual‐Degree Program

PubMed Central

Pillinger, Michael; Plottel, Claudia S.; Galeano, Claudia; Maddalo, Scott; Hochman, Judith S.; Cronstein, Bruce N.; Gold‐von Simson, Gabrielle

2015-01-01

Abstract To develop the next generation of translational investigators, New York University School of Medicine (NYUSOM) and the NYU‐NYC Health and Hospitals Corporation Clinical and Translational Science Institute (NYU‐HHC CTSI) developed the Master's of Science in Clinical Investigation dual‐degree (MD/MSCI) program. This 5‐year program dedicates 1 year to coursework and biomedical research, followed by a medical school/research overlap year, to prepare students for academic research careers. This paper details the MD/MSCI program's curriculum and approach to mentorship, describes the research/professional interests of students, and reports student productivity. In the first 4 years of the program (2010–2014) 20 students were matriculated; 7 (35%) were women, and 12 (60%) research projects were in surgical specialties. To date, 14 students have applied to residency, and half pursued surgical residency programs. Our students have produced 68 accepted abstracts, 15 abstracts in submission, 38 accepted papers, and 24 papers in submission. Despite the time‐limited nature of this program, additional training in research design and implementation has promoted a high level of productivity. We conclude that dual‐degree training in medicine and translational research is feasible for medical students and allows for meaningful participation in valuable projects. Follow‐up is warranted to evaluate the academic trajectory of these students. PMID:26365704

An open trial of mindfulness-based cognitive therapy for the prevention of perinatal depressive relapse/recurrence.

PubMed

Dimidjian, Sona; Goodman, Sherryl H; Felder, Jennifer N; Gallop, Robert; Brown, Amanda P; Beck, Arne

2015-02-01

Pregnant women with histories of depression are at high risk of depressive relapse/recurrence during the perinatal period, and options for relapse/recurrence prevention are limited. Mindfulness-based cognitive therapy (MBCT) has strong evidence among general populations but has not been studied among at-risk pregnant women to prevent depression. We examined the feasibility, acceptability, and clinical outcomes of depression symptom severity and relapse/recurrence associated with MBCT adapted for perinatal women (MBCT-PD). Pregnant women with depression histories were recruited from obstetrics clinics in a large health maintenance organization at two sites and enrolled in MBCT-PD (N = 49). Self-reported depressive symptoms and interview-based assessments of depression relapse/recurrence status were measured at baseline, during MBCT-PD, and through 6-months postpartum. Pregnant women reported interest, engagement, and satisfaction with the program. Retention rates were high, as were rates of completion of daily homework practices. Intent to treat analyses indicated a significant improvement in depression symptom levels and an 18 % rate of relapse/recurrence through 6 months postpartum. MBCT-PD shows promise as an acceptable, feasible, and clinically beneficial brief psychosocial prevention option for pregnant women with histories of depression. Randomized controlled trials are needed to examine the efficacy of MBCT-PD for the prevention of depressive relapse/recurrence during pregnancy and postpartum.

Classifying orofacial pains: a new proposal of taxonomy based on ontology.

PubMed

Nixdorf, D R; Drangsholt, M T; Ettlin, D A; Gaul, C; De Leeuw, R; Svensson, P; Zakrzewska, J M; De Laat, A; Ceusters, W

2012-03-01

We propose a new taxonomy model based on ontological principles for disorders that manifest themselves through the symptom of persistent orofacial pain and are commonly seen in clinical practice and difficult to manage. Consensus meeting of eight experts from various geographic areas representing different perspectives (orofacial pain, headache, oral medicine and ontology) as an initial step towards improving the taxonomy. Ontological principles were introduced, reviewed and applied during the consensus building process. Diagnostic criteria for persistent dento-alveolar pain disorder (PDAP) were formulated as an example to be used to model the taxonomical structure of all orofacial pain conditions. These criteria have the advantage of being (i) anatomically defined, (ii) in accordance with other classification systems for the provision of clinical care, (iii) descriptive and succinct, (iv) easy to adapt for applications in varying settings, (v) scalable and (vi) transferable for the description of pain disorders in other orofacial regions of interest. Limitations are that the criteria introduce new terminology, do not have widespread acceptance and have yet to be tested. These results were presented to the greater conference membership and were unanimously accepted. Consensus for the diagnostic criteria of PDAP was established within this working group. This is an initial first step towards developing a coherent taxonomy for orofacial pain disorders, which is needed to improve clinical research and care. © 2011 Blackwell Publishing Ltd.

A pilot study of yoga as self-care for arthritis in minority communities

PubMed Central

2013-01-01

Background While arthritis is the most common cause of disability, non-Hispanic blacks and Hispanics experience worse arthritis impact despite having the same or lower prevalence of arthritis compared to non-Hispanic whites. People with arthritis who exercise regularly have less pain, more energy, and improved sleep, yet arthritis is one of the most common reasons for limiting physical activity. Mind-body interventions, such as yoga, that teach stress management along with physical activity may be well suited for investigation in both osteoarthritis and rheumatoid arthritis. Yoga users are predominantly white, female, and college educated. There are few studies that examine yoga in minority populations; none address arthritis. This paper presents a study protocol examining the feasibility and acceptability of providing yoga to an urban, minority population with arthritis. Methods/design In this ongoing pilot study, a convenience sample of 20 minority adults diagnosed with either osteoarthritis or rheumatoid arthritis undergo an 8-week program of yoga classes. It is believed that by attending yoga classes designed for patients with arthritis, with racially concordant instructors; acceptability of yoga as an adjunct to standard arthritis treatment and self-care will be enhanced. Self-care is defined as adopting behaviors that improve physical and mental well-being. This concept is quantified through collecting patient-reported outcome measures related to spiritual growth, health responsibility, interpersonal relations, and stress management. Additional measures collected during this study include: physical function, anxiety/depression, fatigue, sleep disturbance, social roles, and pain; as well as baseline demographic and clinical data. Field notes, quantitative and qualitative data regarding feasibility and acceptability are also collected. Acceptability is determined by response/retention rates, positive qualitative data, and continuing yoga practice after three months. Discussion There are a number of challenges in recruiting and retaining participants from a community clinic serving minority populations. Adopting behaviors that improve well-being and quality of life include those that integrate mental health (mind) and physical health (body). Few studies have examined offering integrative modalities to this population. This pilot was undertaken to quantify measures of feasibility and acceptability that will be useful when evaluating future plans for expanding the study of yoga in urban, minority populations with arthritis. Trial registration ClinicalTrials.gov: NCT01617421 PMID:23548052

A pilot study of yoga as self-care for arthritis in minority communities.

PubMed

Middleton, Kimberly R; Ward, Michael M; Haaz, Steffany; Velummylum, Sinthujah; Fike, Alice; Acevedo, Ana T; Tataw-Ayuketah, Gladys; Dietz, Laura; Mittleman, Barbara B; Wallen, Gwenyth R

2013-04-02

While arthritis is the most common cause of disability, non-Hispanic blacks and Hispanics experience worse arthritis impact despite having the same or lower prevalence of arthritis compared to non-Hispanic whites. People with arthritis who exercise regularly have less pain, more energy, and improved sleep, yet arthritis is one of the most common reasons for limiting physical activity. Mind-body interventions, such as yoga, that teach stress management along with physical activity may be well suited for investigation in both osteoarthritis and rheumatoid arthritis. Yoga users are predominantly white, female, and college educated. There are few studies that examine yoga in minority populations; none address arthritis. This paper presents a study protocol examining the feasibility and acceptability of providing yoga to an urban, minority population with arthritis. In this ongoing pilot study, a convenience sample of 20 minority adults diagnosed with either osteoarthritis or rheumatoid arthritis undergo an 8-week program of yoga classes. It is believed that by attending yoga classes designed for patients with arthritis, with racially concordant instructors; acceptability of yoga as an adjunct to standard arthritis treatment and self-care will be enhanced. Self-care is defined as adopting behaviors that improve physical and mental well-being. This concept is quantified through collecting patient-reported outcome measures related to spiritual growth, health responsibility, interpersonal relations, and stress management. Additional measures collected during this study include: physical function, anxiety/depression, fatigue, sleep disturbance, social roles, and pain; as well as baseline demographic and clinical data. Field notes, quantitative and qualitative data regarding feasibility and acceptability are also collected. Acceptability is determined by response/retention rates, positive qualitative data, and continuing yoga practice after three months. There are a number of challenges in recruiting and retaining participants from a community clinic serving minority populations. Adopting behaviors that improve well-being and quality of life include those that integrate mental health (mind) and physical health (body). Few studies have examined offering integrative modalities to this population. This pilot was undertaken to quantify measures of feasibility and acceptability that will be useful when evaluating future plans for expanding the study of yoga in urban, minority populations with arthritis. ClinicalTrials.gov: NCT01617421.

Supercritical fluid chromatography coupled with tandem mass spectrometry: A high-efficiency detection technique to quantify Taxane drugs in whole-blood samples.

PubMed

Jin, Chan; Guan, Jibin; Zhang, Dong; Li, Bing; Liu, Hongzhuo; He, Zhonggui

2017-10-01

We present a technique to rapid determine taxane in blood samples by supercritical fluid chromatography together with mass spectrometry. The aim of this study was to develop a supercritical fluid chromatography with mass spectrometry method for the analysis of paclitaxel, cabazitaxel, and docetaxel in whole-blood samples of rats. Liquid-dry matrix spot extraction was selected in sample preparation procedure. Supercritical fluid chromatography separation of paclitaxel, cabazitaxel, docetaxel, and glyburide (internal standard) was accomplished within 3 min by using the gradient mobile phase consisted of methanol as the compensation solvent and carbon dioxide at a flow rate of 1.0 mL/min. The method was validated regarding specificity, the lower limit of quantification, repeatability, and reproducibility of quantification, extraction recovery, and matrix effects. The lower limit of quantification was found to be 10 ng/mL since it exhibited acceptable precision and accuracy at the corresponding level. All interday accuracies and precisions were within the accepted criteria of ±15% of the nominal value and within ±20% at the lower limit of quantification, implying that the method was reliable and reproducible. In conclusion, this method is a promising tool to support and improve preclinical or clinical pharmacokinetic studies with the taxanes anticancer drugs. © 2017 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

A study to establish reasonable action limits for patient-specific quality assurance in intensity-modulated radiation therapy.

PubMed

Both, Stefan; Alecu, Ionut M; Stan, Andrada R; Alecu, Marius; Ciura, Andrei; Hansen, Jeremy M; Alecu, Rodica

2007-03-07

An effective patient quality assurance (QA) program for intensity-modulated radiation therapy (IMRT) requires accurate and realistic plan acceptance criteria--that is, action limits. Based on dose measurements performed with a commercially available two-dimensional (2D) diode array, we analyzed 747 fluence maps resulting from a routine patient QA program for IMRT plans. The fluence maps were calculated by three different commercially available (ADAC, CMS, Eclipse) treatment planning systems (TPSs) and were delivered using 6-MV X-ray beams produced by linear accelerators. To establish reasonably achievable and clinically acceptable limits for the dose deviations, the agreement between the measured and calculated fluence maps was evaluated in terms of percent dose error (PDE) for a few points and percent of passing points (PPP) for the isodose distribution. The analysis was conducted for each TPS used in the study (365 ADAC, 162 CMS,220 Eclipse), for multiple treatment sites (prostate, pelvis, head and neck, spine, rectum, anus, lung, brain), at the normalization point for 3% percentage difference (%Diff) and 3-mm distance to agreement (DTA) criteria. We investigated the treatment-site dependency of PPP and PDE. The results show that, at 3% and 3-mm criteria, a 95% PPP and 3% PDE can be achieved for prostate treatments and a 90% PPP and 5% PDE are attainable for any treatment site.

Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial.

PubMed

Montoy, Juan Carlos C; Dow, William H; Kaplan, Beth C

2016-01-19

What is the effect of default test offers--opt-in, opt-out, and active choice--on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department? This was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection. 38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected. Active choice is a distinct test regimen, with test acceptance patterns that may best approximate patients' true preferences. Opt-out regimens can substantially increase HIV testing, and opt-in schemes may reduce testing, compared with active choice testing. This study was supported by grant NIA 1RC4AG039078 from the National Institute on Aging. The full dataset is available from the corresponding author. Consent for data sharing was not obtained, but the data are anonymized and risk of identification is low.Trial registration Clinical trials NCT01377857. 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.

Patient choice in opt-in, active choice, and opt-out HIV screening: randomized clinical trial

PubMed Central

Dow, William H; Kaplan, Beth C

2016-01-01

Study question What is the effect of default test offers—opt-in, opt-out, and active choice—on the likelihood of acceptance of an HIV test among patients receiving care in an emergency department? Methods This was a randomized clinical trial conducted in the emergency department of an urban teaching hospital and regional trauma center. Patients aged 13-64 years were randomized to opt-in, opt-out, and active choice HIV test offers. The primary outcome was HIV test acceptance percentage. The Denver Risk Score was used to categorize patients as being at low, intermediate, or high risk of HIV infection. Study answer and limitations 38.0% (611/1607) of patients in the opt-in testing group accepted an HIV test, compared with 51.3% (815/1628) in the active choice arm (difference 13.3%, 95% confidence interval 9.8% to 16.7%) and 65.9% (1031/1565) in the opt-out arm (difference 27.9%, 24.4% to 31.3%). Compared with active choice testing, opt-out testing led to a 14.6 (11.1 to 18.1) percentage point increase in test acceptance. Patients identified as being at intermediate and high risk were more likely to accept testing than were those at low risk in all arms (difference 6.4% (3.4% to 9.3%) for intermediate and 8.3% (3.3% to 13.4%) for high risk). The opt-out effect was significantly smaller among those reporting high risk behaviors, but the active choice effect did not significantly vary by level of reported risk behavior. Patients consented to inclusion in the study after being offered an HIV test, and inclusion varied slightly by treatment assignment. The study took place at a single county hospital in a city that is somewhat unique with respect to HIV testing; although the test acceptance percentages themselves might vary, a different pattern for opt-in versus active choice versus opt-out test schemes would not be expected. What this paper adds Active choice is a distinct test regimen, with test acceptance patterns that may best approximate patients’ true preferences. Opt-out regimens can substantially increase HIV testing, and opt-in schemes may reduce testing, compared with active choice testing. Funding, competing interests, data sharing This study was supported by grant NIA 1RC4AG039078 from the National Institute on Aging. The full dataset is available from the corresponding author. Consent for data sharing was not obtained, but the data are anonymized and risk of identification is low. Trial registration Clinical trials NCT01377857. PMID:26786744

High-resolution dynamic imaging and quantitative analysis of lung cancer xenografts in nude mice using clinical PET/CT

PubMed Central

Wang, Ying Yi; Wang, Kai; Xu, Zuo Yu; Song, Yan; Wang, Chu Nan; Zhang, Chong Qing; Sun, Xi Lin; Shen, Bao Zhong

2017-01-01

Considering the general application of dedicated small-animal positron emission tomography/computed tomography is limited, an acceptable alternative in many situations might be clinical PET/CT. To estimate the feasibility of using clinical PET/CT with [F-18]-fluoro-2-deoxy-D-glucose for high-resolution dynamic imaging and quantitative analysis of cancer xenografts in nude mice. Dynamic clinical PET/CT scans were performed on xenografts for 60 min after injection with [F-18]-fluoro-2-deoxy-D-glucose. Scans were reconstructed with or without SharpIR method in two phases. And mice were sacrificed to extracting major organs and tumors, using ex vivo γ-counting as a reference. Strikingly, we observed that the image quality and the correlation between the all quantitive data from clinical PET/CT and the ex vivo counting was better with the SharpIR reconstructions than without. Our data demonstrate that clinical PET/CT scanner with SharpIR reconstruction is a valuable tool for imaging small animals in preclinical cancer research, offering dynamic imaging parameters, good image quality and accurate data quatification. PMID:28881772

High-resolution dynamic imaging and quantitative analysis of lung cancer xenografts in nude mice using clinical PET/CT.

PubMed

Wang, Ying Yi; Wang, Kai; Xu, Zuo Yu; Song, Yan; Wang, Chu Nan; Zhang, Chong Qing; Sun, Xi Lin; Shen, Bao Zhong

2017-08-08

Considering the general application of dedicated small-animal positron emission tomography/computed tomography is limited, an acceptable alternative in many situations might be clinical PET/CT. To estimate the feasibility of using clinical PET/CT with [F-18]-fluoro-2-deoxy-D-glucose for high-resolution dynamic imaging and quantitative analysis of cancer xenografts in nude mice. Dynamic clinical PET/CT scans were performed on xenografts for 60 min after injection with [F-18]-fluoro-2-deoxy-D-glucose. Scans were reconstructed with or without SharpIR method in two phases. And mice were sacrificed to extracting major organs and tumors, using ex vivo γ-counting as a reference. Strikingly, we observed that the image quality and the correlation between the all quantitive data from clinical PET/CT and the ex vivo counting was better with the SharpIR reconstructions than without. Our data demonstrate that clinical PET/CT scanner with SharpIR reconstruction is a valuable tool for imaging small animals in preclinical cancer research, offering dynamic imaging parameters, good image quality and accurate data quatification.

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

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.

[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%.

Developments in laser Doppler blood perfusion monitoring

NASA Astrophysics Data System (ADS)

Leahy, Martin J.; de Mul, Frits F. M.; Nilsson, Gert E.; Maniewski, Roman; Liebert, Adam

2003-03-01

This paper reviews the development and use of laser Doppler perfusion monitors and imagers. Despite their great success and almost universal applicability in microcirculation research, they have had great difficulty in converting to widespread clinical application. The enormous interest in microvascular blood perfusion coupled with the 'ease of use' of the technique has led to 2000+ publications citing its use. However, useful results can only be achieved with an understanding of the basic principles of the instrumentation and its application in the various clinical disciplines. The basic technical background is explored and definitions of blood perfusion and laser Doppler perfusion are established. The calibration method is then described together with potential routes to standardisation. A guide to the limitations in application of the technique gives the user a clear indication of what can be achieved in new studies as well as possible inadequacy in some published investigations. Finally some clinical applications have found acceptability and these will be explored.

Unresolved issues in excimer laser corneal surgery

NASA Astrophysics Data System (ADS)

Trokel, Stephen L.

1991-06-01

More than one hundred fifty clinical excimer laser units designed for corneal surgery have been developed and sold commercially. Manufacturers include Meditec Lasers in Germany, Summit Engineering, Taunton Technologies, and Visx in the United States, and Synthelabo in France. Furthermore a number of prototypes have been built in the USSR and other countries which are being investigated for their clinical use. While in the United States and Canada, substantial regulation of these devices has limited their distribution and use, sales in other parts of the world have been restricted only by market forces. Early clinical successes have created an enthusiasm for this new technology. In spite of this, substantial technical issues remain uncertain and have not been carefully studied. Indeed we have accepted certain parameters for on an almost serendipitous, empirical basis. It is a proper time to pause and consider the bases for these laser techniques.

Clinical management departments for the neurosciences.

PubMed

Matías-Guiu, J; García-Ramos, R; Ramos, M; Soto, J

2016-01-01

Neuroscience-related clinical management departments (UGC in Spanish) represent a means of organising hospitals to deliver patient-centred care as well as specific clinical and administrative management models. The authors review the different UGC models in Spain and their implementation processes as well as any functional problems. We pay special attention to departments treating neurological patients. Neuroscience-related specialties may offer a good framework for the units that they contain. This may be due to the inherent variability and costs associated with neurological patients, the vital level of coordination that must be present between units providing care, and probably to the dynamic nature of the neurosciences as well. Difficulties associated with implementing and gaining acceptance for the new model have limited such UGCs until now. Copyright © 2013 Sociedad Española de Neurología. Published by Elsevier España, S.L.U. All rights reserved.

The orthodontic-periodontic interrelationship in integrated treatment challenges: a systematic review.

PubMed

Gkantidis, N; Christou, P; Topouzelis, N

2010-05-01

Orthodontic treatment aims at providing an acceptable functional and aesthetic occlusion with appropriate tooth movements. These movements are strongly related to interactions of teeth with their supportive periodontal tissues. In recent years, because of the increased number of adult patients seeking orthodontic treatment, orthodontists frequently face patients with periodontal problems. Aesthetic considerations, like uneven gingival margins or functional problems resulting from inflammatory periodontal diseases should be considered in orthodontic treatment planning. Furthermore, in cases with severe periodontitis, orthodontics may improve the possibilities of saving and restoring a deteriorated dentition. In modern clinical practice, the contribution of the orthodontist, the periodontist and the general dentist is essential for optimized treatment outcomes. The purpose of this systematic review is to highlight the relationship between orthodontics and periodontics in clinical practice and to improve the level of cooperation between dental practitioners. Potentials and limitations that derive from the interdisciplinary approach of complex orthodontic-periodontal clinical problems are discussed.

[Limitations on Therapeutic Efforts: Much More than not Doing].

PubMed

Bernal, Diana Restrepo; Uribe, Clara Cossio

2013-03-01

The term LTE (Limitations on Therapeutic Efforts) refers to the withholding or withdrawing of medical treatment to a patient (either with or without capacity to decide) who does not clinically benefit from it. Although some countries already have legislation and official documents to formalize it, there are several reasons limiting the dissemination and acceptance of this proposal. One is the fact that physicians and health institutions consider this issue as the sole responsibility of patients; another reason is that physicians and the community in general believe the discussion refers just to elderly and terminal patients. It is necessary an academic approach on LTE from both, physicians and the community in general, to promote a sound ethical reflection so as to assist patients and their relatives in the hard task of becoming autonomous to decide and plan their futures. Copyright © 2013 Asociación Colombiana de Psiquiatría. Publicado por Elsevier España. All rights reserved.

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 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.

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.

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.

Using diffusion of innovation theory to understand the factors impacting patient acceptance and use of consumer e-health innovations: a case study in a primary care clinic.

PubMed

Zhang, Xiaojun; Yu, Ping; Yan, Jun; Ton A M Spil, Ir

2015-02-21

Consumer e-Health is a potential solution to the problems of accessibility, quality and costs of delivering public healthcare services to patients. Although consumer e-Health has proliferated in recent years, it remains unclear if patients are willing and able to accept and use this new and rapidly developing technology. Therefore, the aim of this research is to study the factors influencing patients' acceptance and usage of consumer e-health innovations. A simple but typical consumer e-health innovation--an e-appointment scheduling service--was developed and implemented in a primary health care clinic in a regional town in Australia. A longitudinal case study was undertaken for 29 months after system implementation. The major factors influencing patients' acceptance and use of the e-appointment service were examined through the theoretical lens of Rogers' innovation diffusion theory. Data were collected from the computer log records of 25,616 patients who visited the medical centre in the entire study period, and from in-depth interviews with 125 patients. The study results show that the overall adoption rate of the e-appointment service increased slowly from 1.5% at 3 months after implementation, to 4% at 29 months, which means only the 'innovators' had used this new service. The majority of patients did not adopt this innovation. The factors contributing to the low the adoption rate were: (1) insufficient communication about the e-appointment service to the patients, (2) lack of value of the e-appointment service for the majority of patients who could easily make phone call-based appointment, and limitation of the functionality of the e-appointment service, (3) incompatibility of the new service with the patients' preference for oral communication with receptionists, and (4) the limitation of the characteristics of the patients, including their low level of Internet literacy, lack of access to a computer or the Internet at home, and a lack of experience with online health services. All of which are closely associated with the low socio-economic status of the study population. The findings point to a need for health care providers to consider and address the identified factors before implementing more complicated consumer e-health innovations.

Hypnosis for procedure-related pain and distress in pediatric cancer patients: a systematic review of effectiveness and methodology related to hypnosis interventions.

PubMed

Richardson, Janet; Smith, Joanna E; McCall, Gillian; Pilkington, Karen

2006-01-01

The aim of this study was to systematically review and critically appraise the evidence on the effectiveness of hypnosis for procedure-related pain and distress in pediatric cancer patients. A comprehensive search of major biomedical and specialist complementary and alternative medicine databases was conducted. Citations were included from the databases' inception to March 2005. Efforts were made to identify unpublished and ongoing research. Controlled trials were appraised using predefined criteria. Clinical commentaries were obtained for each study. Seven randomized controlled clinical trials and one controlled clinical trial were found. Studies report positive results, including statistically significant reductions in pain and anxiety/distress, but a number of methodological limitations were identified. Systematic searching and appraisal has demonstrated that hypnosis has potential as a clinically valuable intervention for procedure-related pain and distress in pediatric cancer patients. Further research into the effectiveness and acceptability of hypnosis for pediatric cancer patients is recommended.

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.

Influence of finishing/polishing on color stability and surface roughness of composites submitted to accelerated artificial aging.

PubMed

Pinto, Gustavo Da Col dos Santos; Dias, Kleber Campioni; Cruvinel, Diogo Rodrigues; Garcia, Lucas da Fonseca Roberti; Consani, Simonides; Pires-De-Souza, Fernanda de Carvalho Panzeri

2013-01-01

To assess the influence of finishing/polishing procedure on color stability (ΔE ) and surface roughness (R(a)) of composites (Heliomolar and Tetric - color A2) submitted to accelerated artificial aging (AAA). Sixty test specimens were made of each composite (12 mm × 2 mm) and separated into six groups (n = 10), according to the type of finishing/polishing to which they were submitted: C, control; F, tip 3195 F; FF, tip 3195 FF; FP, tip 3195 F + diamond paste; FFP, tip 3195 FF + diamond paste; SF, Sof-Lex discs. After polishing, controlled by an electromechanical system, initial color (spectrophotometer PCB 6807 BYK GARDNER) and R(a) (roughness meter Surfcorder SE 1700, cut-off 0.25 mm) readings were taken. Next, the test specimens were submitted to the AAA procedure (C-UV Comexim) for 384 hours, and at the end of this period, new color readings and R(a) were taken. Statistical analysis [2-way analysis of variance (ANOVA), Bonferroni, P < 0.05] showed that all composites demonstrated ΔE alteration above the clinically acceptable limits, with the exception of Heliomolar composite in FP. The greatest ΔE alteration occurred for Tetric composite in SF (13.38 ± 2.10) statistically different from F and FF (P < 0.05). For R(a), Group F showed rougher samples than FF with statistically significant difference (P < 0.05). In spite of the surface differences, the different finishing/polishing procedures were not capable of providing color stability within the clinically acceptable limits.

An In Vitro Comparison of the Marginal Adaptation Accuracy of CAD/CAM Restorations Using Different Impression Systems.

PubMed

Shembesh, Marwa; Ali, Ala; Finkelman, Matthew; Weber, Hans-Peter; Zandparsa, Roya

2017-10-01

To compare the marginal adaptation of 3-unit zirconia fixed dental prostheses (FDPs) obtained from intraoral digital scanners (Lava True Definition, Cadent iTero), scanning of a conventional silicone impression, and the resulting master cast with an extraoral scanner (3Shape lab scanner). One reference model was fabricated from intact, non-carious, unrestored human mandibular left first premolar and first molar teeth (teeth #19 and 21), prepared for a three-unit all-ceramic FDP. Impressions of the reference model were obtained using four impression systems (n = 10), group 1 (PVS impression scan), group 2 (stone cast scan), group 3 (Cadent iTero), and group 4 (Lava True Defintion). Then the three-unit zirconia FDPs were milled. Marginal adaptation of the zirconia FDPs was evaluated using an optical comparator at four points on each abutment. The mean (SD) was reported for each group. One-way ANOVA was used to assess the statistical significance of the results, with post hoc tests conducted via Tukey's HSD. p < 0.05 was considered statistically significant. All analyses were done using SPSS 22.0. The mean (SD) marginal gaps for the recorded data from highest to lowest were silicone impression scans 81.4 μm (6.8), Cadent iTero scan 62.4 μm (5.0), master cast scan 50.2 μm (6.1), and Lava True definition scan 26.6 μm (4.7). One-way ANOVA revealed significant differences (p < 0.001) in the mean marginal gap among the groups. The Tukey's HSD tests demonstrated that the differences between all groups (silicone impression scan, master cast scan, Lava True definition scan, iTero Cadent scan) were statistically significant (all p < 0.001). On the basis of the criterion of 120 μm as the limit of clinical acceptance, all marginal discrepancy values of all groups were clinically acceptable. Within the confines of this in vitro study, it can be concluded that the marginal gap of all impression techniques was within the acceptable clinical limit (120 μm). Group 4 (Lava True Defintion) showed the lowest average gap among all groups followed by group 2 (stone cast scan), group 3 (Cadent iTero), and group 1 (PVS impression scan); these differences were statistically significant. © 2016 by the American College of Prosthodontists.

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.

12 CFR 7.1007 - Acceptances.

Code of Federal Regulations, 2011 CFR

2011-01-01

... 12 Banks and Banking 1 2011-01-01 2011-01-01 false Acceptances. 7.1007 Section 7.1007 Banks and Banking COMPTROLLER OF THE CURRENCY, DEPARTMENT OF THE TREASURY BANK ACTIVITIES AND OPERATIONS Bank Powers § 7.1007 Acceptances. A national bank is not limited in the character of acceptances it may make in...

Evidence-based medicine for neurosurgeons: introduction and methodology.

PubMed

Linskey, Mark E

2006-01-01

Evidence-based medicine is a tool of considerable value for medicine and neurosurgery that provides a secure base for clinical practice and practice improvement, but is not without inherent drawbacks, weaknesses and limitations. EBM finds answers to only those questions open to its techniques, and the best available evidence can be a far cry from scientific truth. With the support and backing of governmental agencies, professional medical societies, the AAMC, the ACGME, and the ABMS, EBM is likely here to stay. The fact that: (1) EBM philosophy and critical appraisal techniques have become fully integrated into the training and culture of our younger colleagues, (2) that maintenance of certification will require individuals to demonstrate personal evidence based practice based on tracking and critical analysis of personal practice outcomes as part of the performance-based learning and improvement competency, and (3) that the progressively growing national healthcare expenditures will necessitate increasing basis of reimbursement and funding based on evidence-based effectiveness and guidelines, all point to the likelihood that complete immersion of neurosurgical practice in EBM is inevitable. This article thoroughly explores the history of EBM in medicine in general and in neurosurgery in particular. Emphasis is placed on identifying the legislative and regulatory motive forces at work behind its promulgation and the role that organized medicine has taken to facilitate and foster its acceptance and implementation. An accounting of resources open to neurosurgeons, and a detailed description EBM clinical decision-making methodology is presented. Special emphasis is placed on outlining the methodology as well as the limitations of meta-analyses, randomized clinic trials, and clinical practice parameter guidelines. Commonly perceived objections, as well as substantive problems and limitations of EBM assumptions, tools, and approaches both for individual clinical practice and health policy design and implementation are explored in detail.

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

Physiotherapy based on the Bobath concept for adults with post-stroke hemiplegia: a review of effectiveness studies.

PubMed

Paci, Matteo

2003-01-01

The Bobath concept, also known as neurodevelopmental treatment, is a widely used approach in the rehabilitation of hemiparetic subjects in many countries. Despite 50 years of clinical use its effectiveness is questionable. This paper aims to examine whether there is evidence to accept neurodevelopmental treatment as an effective approach. A systematic literature search was undertaken. Fifteen trials have been selected and classified according to a 5-level hierarchic scale of evidence for clinical interventions. Results show no evidence proving the effectiveness of neurodevelopmental treatment or supporting neurodevelopmental treatment as the optimal type of treatment, but neither do methodological limitations allow for conclusions of non-efficacy. Methodological aspects of selected studies are discussed and requirements for further research are suggested.

Dual-energy KUB radiographic examination for the detection of renal calculus.

PubMed

Yen, Peggy; Bailly, Greg; Pringle, Christopher; Barnes, David

2014-08-01

The dual-energy radiographic technique has been proved to be clinically useful in the thorax. Herein, we attempt to apply this technique to the abdomen and pelvis in the context of renal colic. The visibility of renal calculi were assessed using various dual energy peak kilovoltage combination radiographs applied to standard phantoms. This technique demonstrates a higher than acceptable radiation dosage required to optimize the image quality and the optimized diagnostic quality is inferior to that of the standard Kidneys, Ureters, and Bladder radiograph. The dual-energy radiographic technique could not better identify the radiopaque renal calculi. Limiting technical considerations include the increased subcutaneous and peritoneal adipose tissue and the limited contrast between the soft tissue and underlying calculi. Copyright © 2014 AUR. Published by Elsevier Inc. All rights reserved.

The role of theory in the assessment of sex offenders.

PubMed

Quackenbush, Ray E

2003-01-01

No generally accepted theory of sex offender behavior exists at this point. As clinical experience and research findings interact within an evolving theoretical framework, the picture of what is important, as well as what is possible to know about a sex offender, is rapidly changing. It is vital that mental health professionals, the legal system, social service agencies, and other consumers and providers of sex offender assessments be aware of both what is possible to learn about an offender as well as the limitations on that knowledge and its application. Prominent theories that influence the assessment of offenders in North America and Europe are presented and examined. Uses and limitations of each theory are discussed. Several trends emerge which could influence the future of sex offender assessment, treatment, management, and policy.

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.

Chile: Acceptability of a Training Program for Depression Management in Primary Care.

PubMed

Marín, Rigoberto; Martínez, Pablo; Cornejo, Juan P; Díaz, Berta; Peralta, José; Tala, Álvaro; Rojas, Graciela

2016-01-01

In Chile, there are inconsistencies in the management of depression in primary care settings, and the National Depression Program, currently in effect, was implemented without a standardized training program. The objective of this study is to evaluate the acceptability of a training program on the management of depression for primary care health teams. The study was a randomized controlled trial, and two primary centers from the Metropolitan Region of Santiago were randomly selected to carry out the intervention training program. Pre-post surveys were applied, to evaluate expectations and satisfaction with the intervention, respectively. Descriptive and content analysis was carried out. The sample consisted of 41 health professionals, 56.1% of who reported that their expectations for the intervention were met. All of the training activities were evaluated with scores higher than 6.4 (on a 1-7 scale). The trainers, the methodology, and the learning environment were considered strengths and facilitators of the program, while the limited duration of the training, the logistical problems faced during part of the program, and the lack of educational material were viewed as weaknesses. The intervention was well accepted by primary health care teams. However, the clinical impact in patients still has to be evaluated.

Treatment of chronic hepatitis C virus infection in the United States: some remaining obstacles.

PubMed

Searson, Gloria; Engelson, Ellen S; Carriero, Damaris; Kotler, Donald P

2014-05-01

Hepatitis C infection is an important problem in inner city neighbourhoods, which suffer from multiple health disparities. Important factors in this population include alcoholism and substance abuse, mental illness and homelessness, which may be combined with mistrust, poor health literacy, limited access to healthcare and outright discrimination. Systemic barriers to effective care include a lack of capacity to provide comprehensive care, insufficient insurance coverage, poor coordination among caregivers and between caregivers and hospitals, as well as third party payers. These barriers affect real world treatment effectiveness as opposed to treatment efficacy, the latter reflecting the world of clinical trials. The components of effectiveness include efficacious medications, appropriate diagnosis and evaluation, recommendation for therapy, access to therapy, acceptance of the diagnosis and its implications by the patient and adherence to the recommended therapy. Very little attention has been given to assisting the patient to accept the diagnosis and adhere to therapy, i.e. care coordination. For this reason, care coordination is an area in which greater availability could lead to greater acceptance/adherence and greater treatment effectiveness. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Beyond wilderness: Broadening the applicability of limits of acceptable change

Treesearch

Mark W. Brunson

1977-01-01

The Limits of Acceptable Change (LAC) process helps managers preserve wilderness attributes along with recreation opportunities. Ecosystem management likewise requires managers to balance societal and ecosystem needs. Both are more likely to succeed through collaborative planning. Consequently, LAC can offer a conceptual framework for achieving sustainable solutions...

Precepting 101: Teaching Strategies and Tips for Success for Preceptors.

PubMed

Lazarus, Judy

2016-11-01

The current shortage of certified nurse-midwives and certified midwives willing to serve as preceptors for midwifery education programs limits the number of students accepted into education programs. Preceptors are an essential link between academic programs and clinical practice and are indispensable to the growth of the midwifery profession. Preceptors create a safe environment for learning and teach adult learners through a variety of clinical teaching strategies. Novice preceptors need training and support to learn a new role, and experienced preceptors desire continued support and training. Before starting, preceptors need to identify sources of support and mentoring as well as understand the academic program's expectations for the student. This article draws on the clinical education literature to describe approaches to teaching all types of students. Practical strategies for integrating all levels of students into busy clinical settings are identified. Two approaches for clinical teaching, the Five Minute Preceptor and SNAPPS, are discussed in detail. Strategies for providing effective feedback and approaches to student evaluation are provided. © 2016 by the American College of Nurse-Midwives.

Open-label taste-testing study to evaluate the acceptability of both strawberry-flavored and orange-flavored amylmetacresol/2,4-dichlorobenzyl alcohol throat lozenges in healthy children.

PubMed

Thompson, Alex; Reader, Sandie; Field, Emma; Shephard, Adrian

2013-06-01

Acute sore throat (pharyngitis) is one of the most common illnesses for which children are seen by primary care physicians. Most cases are caused by viruses and are benign and self-limiting. Clinically proven, over-the-counter throat lozenges provide rapid and effective relief of acute sore throat symptoms, and are increasingly important in self-management of this condition. The purpose of this study (International Standard Randomized Controlled Trial Number: ISRCTN34958871) was to evaluate the acceptability of two licensed, commercially available sore throat lozenges containing amylmetacresol and 2,4-dichlorobenzyl (AMC/DCBA)--one strawberry flavored and the other orange flavored--in healthy children. This was an open-label, single-dose, crossover, taste-testing study in children recruited via a clinical database and advertisements over a 3.5-week period. Potentially eligible participants were invited to attend the taste-testing session at a clinic. At the screening session, which took place either before or on the day of taste testing, details of relevant medical history, medication, and demographics were recorded. Of the 108 screened subjects, 102 were recruited. These were healthy male and female children aged 6-12 years. Each child cleansed their palate with water and water biscuits before tasting a strawberry-flavored lozenge (Strepsils® strawberry sugar free, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 00063/0395), which was sucked for 1 minute and then expelled. The orange-flavored lozenge (Strepsils® orange with vitamin C, Reckitt Benckiser Healthcare Limited, Nottingham, UK; PL 016242152) was tasted at least 15 minutes later following further cleansing of the palate. The spontaneous reaction of the child on tasting each lozenge was observed and recorded. Subjects were asked to indicate their liking for each lozenge, using a 7-point hedonic facial scale, and were required to answer a series of questions relating to what they liked and disliked about the taste and the feel of the lozenge in the mouth and throat. The primary endpoint was the proportion of subjects with a hedonic facial score of >4. Secondary endpoints included the spontaneous reaction of the child on tasting the lozenge and responses to questions related to taste. The taste of the lozenge was scored >4 (i.e. 'good', 'really good', or 'super good') by 85.3% of subjects for the strawberry flavor and 49.0% for the orange flavor (p < 0.0001). The mean (standard deviation) score was 5.72 (1) for the strawberry-flavored lozenge and 4.35 (2) for the orange-flavored lozenge. The proportion of subjects willing to take the lozenge again was 94% for the strawberry flavor and 56% for the orange flavor. Strawberry-flavored AMC/DCBA lozenges were liked by, and acceptable to, the majority of the children. AMC/DCBA orange-flavored lozenges were also liked by, and acceptable to, approximately half the children. Overall, both strawberry and orange would be suitable flavors for lozenges intended for children when they suffer from sore throat.

Group acceptance and commitment therapy (ACT) for bipolar disorder and co-existing anxiety - an open pilot study.

PubMed

Pankowski, Sara; Adler, Mats; Andersson, Gerhard; Lindefors, Nils; Svanborg, Cecilia

2017-03-01

Previous studies have supported acceptance and commitment therapy (ACT) for reducing impairment related to various chronic conditions. ACT may possibly be beneficial for bipolar disorder (BD) with co-existing anxiety, which is associated with a poorer treatment outcome. Efforts are needed to identify suitable psychological interventions for BD and co-existing anxiety. In this open clinical trial, we included 26 patients with BD type 1 or 2 at an outpatient psychiatric unit specializing in affective disorders. The intervention consisted of a 12-session manualized group treatment that included psychoeducation, mindfulness, engaging in values-based behaviour, cognitive defusion, acceptance and relapse prevention modules. Participants completed four self-report questionnaires covering anxiety symptoms (Beck Anxiety Inventory - BAI), depressive symptoms (Beck Depression Inventory - BDI-II), quality of life (Quality of Life Inventory - QOLI) and psychological flexibility (Acceptance and Action Questionnaire - AAQ-2) before, during and after the treatment. At post-treatment, the participants reported significant improvements in all outcome measures, with large effects (Cohen's d between 0.73 and 1.98). The mean reduction in anxiety symptoms was 45%. At post-treatment, 96% of the patients were classified as responders on at least one of the outcome measures. A limitation is that the trial is uncontrolled. The results suggest that ACT has the potential to be an effective treatment for BD patients with co-existing anxiety. Further randomized studies are warranted.

Feasibility and acceptability of using jumping mechanography to detect early components of sarcopenia in community-dwelling older women

PubMed Central

Hannam, K.; Hartley, A.; Clark, E.M.; Sayer, A. Aihie; Tobias, J.H.; Gregson, C.L.

2017-01-01

Objective: To determine the feasibility and acceptability of using peak power and force, measured by jumping mechanography (JM), to detect early age-related features of sarcopenia in older women. Methods: Community-dwelling women aged 71-87 years were recruited into this cross-sectional study. Physical function tests comprised the short physical performance battery (SPPB), grip strength and, if SPPB score≥6, JM. JM measured peak weight-adjusted power and force from two-footed jumps and one-legged hops respectively. Questionnaires assessed acceptability. Results: 463 women were recruited; 37(8%) with SPPB<6 were ineligible for JM. Of 426 remaining, 359(84%) were able to perform ≥1 valid two-footed jump, 300(70%) completed ≥1 valid one-legged hop. No adverse events occurred. Only 14% reported discomfort. Discomfort related to JM performance, with inverse associations with both power and force (p<0.01). Peak power and force respectively explained 8% and 10% of variance in SPPB score (13% combined); only peak power explained additional variance in grip strength (17%). Conclusions: Peak power and force explained a significant, but limited, proportion of variance in SPPB and grip strength. JM represents a safe and acceptable clinical tool for evaluating lower-limb muscle power and force in older women, detecting distinct components of muscle function, and possibly sarcopenia, compared to those evaluated by more established measures. PMID:28860427

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.

Practice does make perfect. A longitudinal look at repeated taste exposure.

PubMed

Williams, Keith E; Paul, Candace; Pizzo, Bianca; Riegel, Katherine

2008-11-01

Previous research has found that 10-15 exposures to a novel food found can increase liking and consumption. This research has been, however, largely limited cross-sectional studies in which participants are offered only one or a few novel foods. The goal of the current study uses a small clinical sample to demonstrate the number of exposures required for consumption of novel foods decreases as a greater number of foods are added to the diet. Evidence that fewer exposures are needed over time may make interventions based upon repeated exposure more acceptable to parents and clinicians.

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®.

[Privacy and confidentiality in adolescent health care: perceptions and behavior of a group of 711 college students].

PubMed

Loch, Jussara de Azambuja; Clotet, Joaquim; Goldim, José Roberto

2007-01-01

To understand the opinion and behavior of a group of college students about the degree of privacy considered appropriate in several clinical settings and in which situations breach of confidentiality is admitted. An anonymous questionnaire about confidentiality in clinical settings was answered by 711 college students. The study had a transversal, descriptive, qualitative-quantitative design. We studied recognition of the ethical criteria for confidentiality limitation, and in which situations, common in adolescent morbidity, disclosure of this information is accepted. Data analysis used Epi-Info 6.04 and Microsoft Excel, 1997. The research was approved by PUCRS' IRB. The ideal situation for disclosing information was considered by 82% of the adolescents as the previous granting of authorization, which differs from other forms of breaching confidentiality. In cases of non-authorized disclosure, most of them admitted that it in case of suicidal ideation (85%), violence (84.2%), sexual abuse (81.7%), nervous anorexia (81.3%) and risk of life to third parties (72.3%). Half of them agree to it in HIV/AIDS (57.9%), drug abuse (51.7%) and STD (44.7%) situations; less than one third accept it in situations of pregnancy (33.6%), homosexuality (20.7%) and sexual activity (15.6%). Participants assigned different grades to the value of confidentiality in their health care, accepting that information may be disclosed to others when the patient authorizes it. The higher the risk to their integrity, the easier it was for them to admit non-authorized disclosure of information, however in aspects related to their sexuality disclosure is practically denied.

The national portfolio of learning for postgraduate family medicine training in South Africa: experiences of registrars and supervisors in clinical practice

PubMed Central

2013-01-01

Background In South Africa the submission of a portfolio of learning has become a national requirement for assessment of family medicine training. A national portfolio has been developed, validated and implemented. The aim of this study was to explore registrars’ and supervisors’ experience regarding the portfolio’s educational impact, acceptability, and perceived usefulness for assessment of competence. Methods Semi-structured interviews were conducted with 17 purposively selected registrars and supervisors from all eight South African training programmes. Results The portfolio primarily had an educational impact through making explicit the expectations of registrars and supervisors in the workplace. This impact was tempered by a lack of engagement in the process by registrars and supervisors who also lacked essential skills in reflection, feedback and assessment. The acceptability of the portfolio was limited by service delivery demands, incongruence between the clinical context and educational requirements, design of the logbook and easy availability of the associated tools. The use of the portfolio for formative assessment was strongly supported and appreciated, but was not always happening and in some cases registrars had even organised peer assessment. Respondents were unclear as to how the portfolio would be used for summative assessment. Conclusions The learning portfolio had a significant educational impact in shaping work-place based supervision and training and providing formative assessment. Its acceptability and usefulness as a learning tool should increase over time as supervisors and registrars become more competent in its use. There is a need to clarify how it will be used in summative assessment. PMID:24207009

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.

The national portfolio of learning for postgraduate family medicine training in South Africa: experiences of registrars and supervisors in clinical practice.

PubMed

Jenkins, Louis; Mash, Bob; Derese, Anselme

2013-11-08

In South Africa the submission of a portfolio of learning has become a national requirement for assessment of family medicine training. A national portfolio has been developed, validated and implemented. The aim of this study was to explore registrars' and supervisors' experience regarding the portfolio's educational impact, acceptability, and perceived usefulness for assessment of competence. Semi-structured interviews were conducted with 17 purposively selected registrars and supervisors from all eight South African training programmes. The portfolio primarily had an educational impact through making explicit the expectations of registrars and supervisors in the workplace. This impact was tempered by a lack of engagement in the process by registrars and supervisors who also lacked essential skills in reflection, feedback and assessment. The acceptability of the portfolio was limited by service delivery demands, incongruence between the clinical context and educational requirements, design of the logbook and easy availability of the associated tools. The use of the portfolio for formative assessment was strongly supported and appreciated, but was not always happening and in some cases registrars had even organised peer assessment. Respondents were unclear as to how the portfolio would be used for summative assessment. The learning portfolio had a significant educational impact in shaping work-place based supervision and training and providing formative assessment. Its acceptability and usefulness as a learning tool should increase over time as supervisors and registrars become more competent in its use. There is a need to clarify how it will be used in summative assessment.

Virtual online consultations: advantages and limitations (VOCAL) study.

PubMed

Greenhalgh, Trisha; Vijayaraghavan, Shanti; Wherton, Joe; Shaw, Sara; Byrne, Emma; Campbell-Richards, Desirée; Bhattacharya, Satya; Hanson, Philippa; Ramoutar, Seendy; Gutteridge, Charles; Hodkinson, Isabel; Collard, Anna; Morris, Joanne

2016-01-29

Remote video consultations between clinician and patient are technically possible and increasingly acceptable. They are being introduced in some settings alongside (and occasionally replacing) face-to-face or telephone consultations. To explore the advantages and limitations of video consultations, we will conduct in-depth qualitative studies of real consultations (microlevel) embedded in an organisational case study (mesolevel), taking account of national context (macrolevel). The study is based in 2 contrasting clinical settings (diabetes and cancer) in a National Health Service (NHS) acute trust in London, UK. Main data sources are: microlevel--audio, video and screen capture to produce rich multimodal data on 45 remote consultations; mesolevel--interviews, ethnographic observations and analysis of documents within the trust; macrolevel--key informant interviews of national-level stakeholders and document analysis. Data will be analysed and synthesised using a sociotechnical framework developed from structuration theory. City Road and Hampstead NHS Research Ethics Committee, 9 December 2014, reference 14/LO/1883. We plan outputs for 5 main audiences: (1) academics: research publications and conference presentations; (2) service providers: standard operating procedures, provisional operational guidance and key safety issues; (3) professional bodies and defence societies: summary of relevant findings to inform guidance to members; (4) policymakers: summary of key findings; (5) patients and carers: 'what to expect in your virtual consultation'. The research literature on video consultations is sparse. Such consultations offer potential advantages to patients (who are spared the cost and inconvenience of travel) and the healthcare system (eg, they may be more cost-effective), but fears have been expressed that they may be clinically risky and/or less acceptable to patients or staff, and they bring significant technical, logistical and regulatory challenges. We anticipate that this study will contribute to a balanced assessment of when, how and in what circumstances this model might be introduced. 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/

An Atmospheric Pressure Chemical Ionization MS/MS Assay Using Online Extraction for the Analysis of 11 Cannabinoids and Metabolites in Human Plasma and Urine.

PubMed

Klawitter, Jelena; Sempio, Cristina; Mörlein, Sophie; De Bloois, Erik; Klepacki, Jacek; Henthorn, Thomas; Leehey, Maureen A; Hoffenberg, Edward J; Knupp, Kelly; Wang, George S; Hopfer, Christian; Kinney, Greg; Bowler, Russell; Foreman, Nicholas; Galinkin, Jeffrey; Christians, Uwe; Klawitter, Jost

2017-10-01

Although, especially in the United States, there has been a recent surge of legalized cannabis for either recreational or medicinal purposes, surprisingly little is known about clinical dose-response relationships, pharmacodynamic and toxicodynamic effects of cannabinoids such as Δ9-tetrahydrocannabinol (THC). Even less is known about other active cannabinoids. To address this knowledge gap, an online extraction, high-performance liquid chromatography coupled with tandem mass spectrometry method for simultaneous quantification of 11 cannabinoids and metabolites including THC, 11-hydroxy-Δ9-tetrahydrocannabinol, 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid, 11-nor-Δ9-tetrahydrocannabinol-9-carboxylic acid glucuronide (THC-C-gluc), cannabinol, cannabidiol, cannabigerol, cannabidivarin, Δ9-tetrahydrocannabivarin (THCV), and 11-nor-9-carboxy-Δ9-tetrahydrocannabivarin (THCV-COOH) was developed and validated in human urine and plasma. In contrast to atmospheric pressure chemical ionization, electrospray ionization was associated with extensive ion suppression in plasma and urine samples. Thus, the atmospheric pressure chemical ionization assay was validated showing a lower limit of quantification ranging from 0.39 to 3.91 ng/mL depending on study compound and matrix. The upper limit of quantification was 400 ng/mL except for THC-C-gluc with an upper limit of quantification of 2000 ng/mL. The linearity was r > 0.99 for all analyzed calibration curves. Acceptance criteria for intrabatch and interbatch accuracy (85%-115%) and imprecision (<15%) were met for all compounds. In plasma, the only exceptions were THCV (75.3%-121.2% interbatch accuracy) and cannabidivarin (interbatch imprecision, 15.7%-17.2%). In urine, THCV did not meet predefined acceptance criteria for intrabatch accuracy. This assay allows for monitoring not only THC and its major metabolites but also major cannabinoids that are of interest for marijuana research and clinical practice.

Dried blood spot HIV-1 RNA quantification: A useful tool for viral load monitoring among HIV-infected individuals in India

PubMed Central

Neogi, Ujjwal; Gupta, Soham; Rodridges, Rashmi; Sahoo, Pravat Nalini; Rao, Shwetha D.; Rewari, Bharat B.; Shastri, Suresh; De Costa, Ayesha; Shet, Anita

2012-01-01

Background & objectives: Monitoring of HIV-infected individuals on antiretroviral treatment (ART) ideally requires periodic viral load measurements to ascertain adequate response to treatment. While plasma viral load monitoring is widely available in high-income settings, it is rarely used in resource-limited regions because of high cost and need for sophisticated sample transport. Dried blood spot (DBS) as source specimens for viral load measurement has shown promise as an alternative to plasma specimens and is likely to be a useful tool for Indian settings. The present study was undertaken to investigate the performance of DBS in HIV-1 RNA quantification against the standard plasma viral load assay. Methods: Between April-June 2011, 130 samples were collected from HIV-1-infected (n=125) and non-infected (n=5) individuals in two district clinics in southern India. HIV-1 RNA quantification was performed from DBS and plasma using Abbott m2000rt system after manual RNA extraction. Statistical analysis included correlation, regression and Bland-Altman analysis. Results: The sensitivity of DBS viral load was 97 per cent with viral loads >3.0 log10 copies/ml. Measurable viral load (>3.0 log 10 copies/ml) results obtained for the 74 paired plasma-DBS samples showed positive correlation between both the assays (r=0.96). For clinically acceptable viral load threshold values of >5,000 copies/ml, Bland-Altman plots showed acceptable limits of agreement (−0.21 to +0.8 log10 copies/ml). The mean difference was 0.29 log10 copies/ml. The cost of DBS was $2.67 lower compared to conventional plasma viral load measurement in the setting Interpretation & conclusions: The significant positive correlation with standard plasma-based assay and lower cost of DBS viral load monitoring suggest that DBS sampling can be a feasible and economical means of viral load monitoring in HIV-infected individual in India and in other resource-limited settings globally. PMID:23391790

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

SU-F-19A-09: Propagation of Organ at Risk Contours for High Dose Rate Brachytherapy Planning for Cervical Cancer: A Deformable Image Registration Comparison

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

Bellon, M; Kumarasiri, A; Kim, J

Purpose: To compare the performance of two deformable image registration (DIR) algorithms for contour propagation and to evaluate the accuracy of DIR for use with high dose rate (HDR) brachytherapy planning for cervical cancer. Methods: Five patients undergoing HDR ring and tandem brachytherapy were included in this retrospective study. All patients underwent CT simulation and replanning prior to each fraction (3–5 fractions total). CT-to-CT DIR was performed using two commercially available software platforms: SmartAdapt, Varian Medical Systems (Demons) and Velocity AI, Velocity Medical Solutions (B-spline). Fraction 1 contours were deformed and propagated to each subsequent image set and compared tomore » contours manually drawn by an expert clinician. Dice similarity coefficients (DSC), defined as, DSC(A,B)=2(AandB)/(A+B) were calculated to quantify spatial overlap between manual (A) and deformed (B) contours. Additionally, clinician-assigned visual scores were used to describe and compare the performance of each DIR method and ultimately evaluate which was more clinically acceptable. Scoring was based on a 1–5 scale—with 1 meaning, “clinically acceptable with no contour changes” and 5 meaning, “clinically unacceptable”. Results: Statistically significant differences were not observed between the two DIR algorithms. The average DSC for the bladder, rectum and rectosigmoid were 0.82±0.08, 0.67±0.13 and 0.48±0.18, respectively. The poorest contour agreement was observed for the rectosigmoid due to limited soft tissue contrast and drastic anatomical changes, i.e., organ shape/filling. Two clinicians gave nearly equivalent average scores of 2.75±0.91 for SmartAdapt and 2.75±0.94 for Velocity AI—indicating that for a majority of the cases, more than one of the three contours evaluated required major modifications. Conclusion: Limitations of both DIR algorithms resulted in inaccuracies in contour propagation in the pelvic region, thus hampering the clinical utility of this technology. Further work is required to optimize these algorithms and take advantage of the potential of DIR for HDR brachytherapy planning.« less

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.

Assessing FDG-PET diagnostic accuracy studies to develop recommendations for clinical use in dementia.

PubMed

Boccardi, Marina; Festari, Cristina; Altomare, Daniele; Gandolfo, Federica; Orini, Stefania; Nobili, Flavio; Frisoni, Giovanni B

2018-04-30

FDG-PET is frequently used as a marker of synaptic damage to diagnose dementing neurodegenerative disorders. We aimed to adapt the items of evidence quality to FDG-PET diagnostic studies, and assess the evidence available in current literature to assist Delphi decisions for European recommendations for clinical use. Based on acknowledged methodological guidance, we defined the domains, specific to FDG-PET, required to assess the quality of evidence in 21 literature searches addressing as many Population Intervention Comparison Outcome (PICO) questions. We ranked findings for each PICO and fed experts making Delphi decisions for recommending clinical use. Among the 1435 retrieved studies, most lacked validated measures of test performance, an adequate gold standard, and head-to-head comparison of FDG-PET and clinical diagnosis, and only 58 entered detailed assessment. Only two studies assessed the accuracy of the comparator (clinical diagnosis) versus any kind of gold-/reference-standard. As to the index-test (FDG-PET-based diagnosis), an independent gold-standard was available in 24% of the examined papers; 38% used an acceptable reference-standard (clinical follow-up); and 38% compared FDG-PET-based diagnosis only to baseline clinical diagnosis. These methodological limitations did not allow for deriving recommendations from evidence. An incremental diagnostic value of FDG-PET versus clinical diagnosis or lack thereof cannot be derived from the current literature. Many of the observed limitations may easily be overcome, and we outlined them as research priorities to improve the quality of current evidence. Such improvement is necessary to outline evidence-based guidelines. The available data were anyway provided to expert clinicians who defined interim recommendations.

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

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.

40 CFR 227.27 - Limiting permissible con-cen-tra-tion (LPC).

Code of Federal Regulations, 2012 CFR

2012-07-01

... 40 Protection of Environment 26 2012-07-01 2011-07-01 true Limiting permissible con-cen-tra-tion... scientific literature or accepted by EPA as being reliable test organisms to determine the anticipated impact... for each type they represent, and that are documented in the scientific literature and accepted by EPA...

What influences patients’ acceptance of a blood pressure telemonitoring service in primary care? A qualitative study

PubMed Central

Abdullah, Adina; Liew, Su May; Hanafi, Nik Sherina; Ng, Chirk Jenn; Lai, Pauline Siew Mei; Chia, Yook Chin; Loo, Chu Kiong

2016-01-01

Background Telemonitoring of home blood pressure (BP) is found to have a positive effect on BP control. Delivering a BP telemonitoring service in primary care offers primary care physicians an innovative approach toward management of their patients with hypertension. However, little is known about patients’ acceptance of such service in routine clinical care. Objective This study aimed to explore patients’ acceptance of a BP telemonitoring service delivered in primary care based on the technology acceptance model (TAM). Methods A qualitative study design was used. Primary care patients with uncontrolled office BP who fulfilled the inclusion criteria were enrolled into a BP telemonitoring service offered between the period August 2012 and September 2012. This service was delivered at an urban primary care clinic in Kuala Lumpur, Malaysia. Twenty patients used the BP telemonitoring service. Of these, 17 patients consented to share their views and experiences through five in-depth interviews and two focus group discussions. An interview guide was developed based on the TAM. The interviews were audio-recorded and transcribed verbatim. Thematic analysis was used for analysis. Results Patients found the BP telemonitoring service easy to use but struggled with the perceived usefulness of doing so. They expressed confusion in making sense of the monitored home BP readings. They often thought about the implications of these readings to their hypertension management and overall health. Patients wanted more feedback from their doctors and suggested improvement to the BP telemonitoring functionalities to improve interactions. Patients cited being involved in research as the main reason for their intention to use the service. They felt that patients with limited experience with the internet and information technology, who worked out of town, or who had an outdoor hobby would not be able to benefit from such a service. Conclusion Patients found BP telemonitoring service in primary care easy to use but needed help to interpret the meanings of monitored BP readings. Implementations of BP telemonitoring service must tackle these issues to maximize the patients’ acceptance of a BP telemonitoring service. PMID:26869773

Perceptions on use of home telemonitoring in patients with long term conditions - concordance with the Health Information Technology Acceptance Model: a qualitative collective case study.

PubMed

Middlemass, Jo B; Vos, Jolien; Siriwardena, A Niroshan

2017-06-26

Health information technology (HIT) may be used to improve care for increasing numbers of older people with long term conditions (LTCs) who make high demands on health and social care services. Despite its potential benefits for reducing disease exacerbations and hospitalisations, HIT home monitoring is not always accepted by patients. Using the Health Information Technology Acceptance Model (HITAM) this qualitative study examined the usefulness of the model for understanding acceptance of HIT in older people (≥60 years) participating in a RCT for older people with Chronic Obstructive Pulmonary Disease (COPD) and associated heart diseases (CHROMED). An instrumental, collective case study design was used with qualitative interviews of patients in the intervention arm of CHROMED. These were conducted at two time points, one shortly after installation of equipment and again at the end of (or withdrawal from) the study. We used Framework Analysis to examine how well the HITAM accounted for the data. Participants included 21 patients aged between 60-99 years and their partners or relatives where applicable. Additional concepts for the HITAM for older people included: concerns regarding health professional access and attachment; heightened illness anxiety and desire to avoid continuation of the 'sick-role'. In the technology zone, HIT self-efficacy was associated with good organisational processes and informal support; while ease of use was connected to equipment design being suitable for older people. HIT perceived usefulness was related to establishing trends in health status, detecting early signs of infection and potential to self-manage. Due to limited feedback to users opportunities to self-manage were reduced. HITAM helped understand the likelihood that older people with LTCs would use HIT, but did not explain how this might result in improved self-management. In order to increase HIT acceptance among older people, equipment design and organisational factors need to be considered. ClinicalTrials.gov Identifier: NCT01960907 October 9 2013 (retrospectively registered) Clinical tRials fOr elderly patients with MultiplE Disease (CHROMED). Start date October 2012, end date March 2016. Date of enrolment of the first participant was February 2013.

Comparing the acceptability of a positive psychology intervention versus a cognitive behavioural therapy for clinical depression.

PubMed

Lopez-Gomez, Irene; Chaves, Covadonga; Hervas, Gonzalo; Vazquez, Carmelo

2017-09-01

There is growing evidence on the efficacy of positive psychology interventions (PPI) to treat clinical disorders. However, very few studies have addressed their acceptability. The present study aimed to analyse 2 key components of acceptability (i.e., client satisfaction and adherence to treatment) of a new PPI programme, the Integrative Positive Psychological Intervention for Depression (IPPI-D), in comparison to a standard cognitive behavioural therapy (CBT) programme in the treatment of clinical depression. One hundred twenty-eight women with a DSM-IV diagnosis of major depression or dysthymia were allocated to a 10-session IPPI-D or CBT group intervention condition. Results showed that both interventions were highly acceptable for participants. Attendance rates were high, and there were no significant differences between conditions. However, the IPPI-D condition showed significantly higher client satisfaction than the CBT condition. Moreover, acceptability did not differ based on participants' severity of symptoms, regardless of condition. These findings encourage further investigations of the applicability of PPI in clinical settings in order to broaden the range of acceptable and suitable therapies for depressed patients. Key Practitioner Message This study sheds light on the client satisfaction and adherence to a positive intervention. For participants, positive psychology interventions (PPI) may be more satisfactory than CBT as PPI are framed within a positive mental health model and, consequently, may reduce the risk of stigmatization Because acceptability of treatments and preferences may affect the efficacy of treatments, this study provides an excellent opportunity to offer professionals more therapeutic options to tailor treatments to clients' needs and expectations. Copyright © 2017 John Wiley & Sons, Ltd.

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.

Feasibility and acceptability of a decision aid designed for people facing advanced or terminal illness: a pilot randomized trial.

PubMed

Matlock, Dan D; Keech, Tarah A E; McKenzie, Marlene B; Bronsert, Michael R; Nowels, Carolyn T; Kutner, Jean S

2014-02-01

Patients nearing the end of their lives face an array of difficult decisions. This study was designed to assess the feasibility and acceptability of a decision aid (DA) designed for patients facing advanced or terminal illness. We conducted a pilot randomized clinical trial of Health Dialog's Looking Ahead: choices for medical care when you're seriously ill DA (booklet and DVD) applied to patients on a hospital-based palliative care (PC) service. University of Colorado Hospital - December 2009 and May 2010. All adult, English-speaking patients or their decision makers were potentially eligible. Patients were not approached if they were in isolation, did not speak English or if any provider felt that they were not appropriate because of issues such as family conflict or actively dying. All participants received a standard PC consultation. Participants in the intervention arm also received a copy of the DA. Measurements Primary outcomes included decision conflict and knowledge. Participants in the intervention arm also completed an acceptability questionnaire and qualitative exit interviews. Of the 239 patients or decision makers, 51(21%) enrolled in the trial. The DA had no significant effect on decision conflict or knowledge. Exit interviews indicated it was acceptable and empowering, although they wished they had access to the DA earlier. While the DA was acceptable, feasibility was limited by late-life illness challenges. Future trials of this DA should be performed on patients earlier in their illness trajectory and should include additional outcome measures such as self-efficacy and confidence. © 2011 John Wiley & Sons Ltd.

The Future of Clinical Education: Opportunities and Challenges from Allied Health Deans' Perspective.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2017-01-01

There is limited information and consensus on the future of clinical education and the key factors impacting allied health (AH) clinical training. AH deans identified both opportunities and challenges impacting clinical education based on a proposed educational model. From July 2013 to March 2014, 61 deans whose institutions were 2013 members of the Association of Schools of Allied Health Professions (ASAHP) participated in a three-round Delphi survey. Agreement on the relative importance of and the ability to impact the key factors was analyzed. Impact was evaluated for three groups: individual, collective, and both individual and collective deans. AH deans' responses were summarized and refined; individual items were accepted or rerated until agreement was achieved or study conclusion. Based on the deans' ratings of importance and impact, 159 key factors within 13 clinical education categories emerged as important for the future of clinical education. Agreement was achieved on 107 opportunities and 52 challenges. The Delphi technique generated new information where little existed specific to AH deans' perspectives on AH clinical education. This research supports the Key Factors Impacting Allied Health Clinical Education conceptual model proposed earlier and provides a foundation for AH deans to evaluate opportunities and challenges impacting AH clinical education and to design action plans based on this research.

Women's experiences of continuous fetal monitoring - a mixed-methods systematic review.

PubMed

Crawford, Alexandra; Hayes, Dexter; Johnstone, Edward D; Heazell, Alexander E P

2017-12-01

Antepartum stillbirth is often preceded by detectable signs of fetal compromise, including changes in fetal heart rate and movement. It is hypothesized that continuous fetal monitoring could detect these signs more accurately and objectively than current forms of fetal monitoring and allow for timely intervention. This systematic review aimed to explore available evidence on women's experiences of continuous fetal monitoring to investigate its acceptability before clinical implementation and to inform clinical studies. Systematic searching of four electronic databases (Embase, PsycINFO, MEDLINE and CINAHL), using key terms defined by initial scoping searches, identified a total of 35 studies. Following title and abstract screening by two independent researchers, five studies met the inclusion criteria. Studies were not excluded based on language, methodology or quality assessment. An integrative methodology was used to synthesize qualitative and quantitative data together. Forms of continuous fetal monitoring used included Monica AN24 monitors (n = 4) and phonocardiography (n = 1). Four main themes were identified: practical limitations of the device, negative emotions, positive perceptions, and device implementation. Continuous fetal monitoring was reported to have high levels of participant satisfaction and was preferred by women to intermittent cardiotocography. This review suggests that continuous fetal monitoring is accepted by women. However, it has also highlighted both the paucity and heterogeneity of current studies and suggests that further research should be conducted into women's experiences of continuous fetal monitoring before such devices can be used clinically. © 2017 Nordic Federation of Societies of Obstetrics and Gynecology.

Factors affecting acceptance of provider-initiated HIV testing and counseling services among outpatient clients in selected health facilities in Harar Town, Eastern Ethiopia.

PubMed

Abdurahman, Sami; Seyoum, Berhanu; Oljira, Lemessa; Weldegebreal, Fitsum

2015-01-01

To improve the slow uptake of HIV counseling and testing, the World Health Organization (WHO) and the Joint United Nations Programme on HIV/AIDS (UNAIDS) have developed draft guidelines on provider-initiated testing and counseling (PITC). Both in low- and high-income countries, mainly from outpatient clinics and tuberculosis settings, indicates that the direct offer of HIV testing by health providers can result in significant improvements in test uptake. In Ethiopia, there were limited numbers of studies conducted regarding PITC in outpatient clinics. Therefore, in this study, we have assessed the factors affecting the acceptance of PITC among outpatient clients in selected health facilities in Harar, Harari Region State, Ethiopia. Institutional-based, cross-sectional quantitative and qualitative studies were conducted from February 12-30, 2011 in selected health facilities in Harar town, Harari Region State, Ethiopia. The study participants were recruited from the selected health facilities of Harar using a systematic random sampling technique. The collected data were double entered into a data entry file using Epi Info version 3.5.1. The data were transferred to SPSS software version 16 and analyzed according to the different variables. A total of 362 (70.6%) clients accepted PITC, and only 39.4% of clients had heard of PITC in the outpatient department service. Age, occupation, marital status, anyone who wanted to check their HIV status, and the importance of PITC were the variables that showed significant associations with the acceptance of PITC upon bivariate and multivariate analyses. The main reasons given for not accepting the tests were self-trust, not being at risk for HIV, not being ready, needing to consult their partners, a fear of the results, a shortage of staff, a busy work environment, a lack of private rooms, and a lack of refresher training, which were identified as the main barriers for PITC. There is evidence of the relatively increased acceptability of PITC services by outpatient department clients. A program needs to be strengthened to enhance the use of PITC; the Ministry of Health, Regional Health Bureau, and other responsible bodies - including health facilities - should design and strengthen information education and communication/behavioral change and communication interventions and promote activities related to PITC and HIV counseling and testing in both health facilities and the community at large.

Implementation of Out-of-Office Blood Pressure Monitoring in the Netherlands: From Clinical Guidelines to Patients' Adoption of Innovation.

PubMed

Carrera, Pricivel M; Lambooij, Mattijs S

2015-10-01

Out-of-office blood pressure monitoring is promoted by various clinical guidelines toward properly diagnosing and effectively managing hypertension and engaging the patient in their care process. In the Netherlands, however, the Dutch cardiovascular risk management (CVRM) guidelines do not explicitly prescribe 24-hour ambulatory blood pressure measurement (ABPM) and home BP measurement (HBPM). The aim of this descriptive study was to develop an understanding of patients' and physicians' acceptance and use of out-of-office BP monitoring in the Netherlands given the CVRM recommendations.Three small focus group discussions (FGDs) with patients and 1 FGD with physicians were conducted to explore the mechanisms behind the acceptance and use of out-of-office BP monitoring and reveal real-world challenges that limit the implementation of out-of-office BP monitoring methods. To facilitate the FGDs, an analytical framework based on the technology acceptance model (TAM), the theory of planned behavior and the model of personal computing utilization was developed to guide the FGDs and analysis of the transcriptions of each FGD.ABPM was the out-of-office BP monitoring method prescribed by physicians and used by patients. HBPM was not offered to patients even with patients' feedback of poor tolerance of ABPM. Even as there was little awareness about HBPM among patients, there were a few patients who owned and used sphygmomanometers. Patients professed and seemed to exhibit self-efficacy, whereas physicians had reservations about (all of their) patients' self-efficacy in properly using ABPM. Since negative experience with ABPM impacted patients' acceptance of ABPM, the interaction of factors that determined acceptance and use was found to be dynamic among patients but not for physicians.In reference to the CVRM guidelines, physicians implemented out-of-office BP monitoring but showed a strong preference for ABPM even where there is poor tolerance of the method. We found that physicians' positive attitude to ABPM enabled the use of the method by patients which, in turn, impeded the diffusion of HBPM. For patients, the acceptance process of HBPM can only begin after the physician has adopted the innovation. Physicians are in a position to encourage as well as hinder out-of-office BP monitoring and self-management.

A study to establish reasonable action limits for patient‐specific quality assurance in intensity‐modulated radiation therapy

PubMed Central

Alecu, Ionut M.; Stan, Andrada R.; Alecu, Marius; Ciura, Andrei; Hansen, Jeremy M.; Alecu, Rodica

2007-01-01

An effective patient quality assurance (QA) program for intensity‐modulated radiation therapy (IMRT) requires accurate and realistic plan acceptance criteria—that is, action limits. Based on dose measurements performed with a commercially available two‐dimensional (2D) diode array, we analyzed 747 fluence maps resulting from a routine patient QA program for IMRT plans. The fluence maps were calculated by three different commercially available (ADAC, CMS, Eclipse) treatment planning systems (TPSs) and were delivered using 6‐MV X‐ray beams produced by linear accelerators. To establish reasonably achievable and clinically acceptable limits for the dose deviations, the agreement between the measured and calculated fluence maps was evaluated in terms of percent dose error (PDE) for a few points and percent of passing points (PPP) for the isodose distribution. The analysis was conducted for each TPS used in the study (365 ADAC, 162 CMS, 220 Eclipse), for multiple treatment sites (prostate, pelvis, head and neck, spine, rectum, anus, lung, brain), at the normalization point for 3% percentage difference (%Diff) and 3‐mm distance to agreement (DTA) criteria. We investigated the treatment‐site dependency of PPP and PDE. The results show that, at 3% and 3‐mm criteria, a 95% PPP and 3% PDE can be achieved for prostate treatments and a 90% PPP and 5% PDE are attainable for any treatment site. PACS Numbers: 87.53Dq, 87.53Tf, 87.53Xd, 87.56Fc PMID:17592459

Assessment of national dosimetry quality audits results for teletherapy machines from 1989 to 2015.

PubMed

Muhammad, Wazir; Ullah, Asad; Mahmood, Khalid; Matiullah

2016-01-01

The purpose of this study was to ensure accuracy in radiation dose delivery, external dosimetry quality audit has an equal importance with routine dosimetry performed at clinics. To do so, dosimetry quality audit was organized by the Secondary Standard Dosimetry Laboratory (SSDL) of Pakistan Institute of Nuclear Science and Technology (PINSTECH) at the national level to investigate and minimize uncertainties involved in the measurement of absorbed dose, and to improve the accuracy of dose measurement at different radiotherapy hospitals. A total of 181 dosimetry quality audits (i.e., 102 of Co-60 and 79 of linear accelerators) for teletherapy units installed at 22 different sites were performed from 1989 to 2015. The percent deviation between users’ calculated/stated dose and evaluated dose (in the result of on-site dosimetry visits) were calculated and the results were analyzed with respect to the limits of ± 2.5% (ICRU "optimal model") ± 3.0% (IAEA on-site dosimetry visits limit) and ± 5.0% (ICRU minimal or "lowest acceptable" model). The results showed that out of 181 total on-site dosimetry visits, 20.44%, 16.02%, and 4.42% were out of acceptable limits of ± 2.5% ± 3.0%, and ± 5.0%, respectively. The importance of a proper ongoing quality assurance program, recommendations of the followed protocols, and properly calibrated thermometers, pressure gauges, and humidity meters at radiotherapy hospitals are essential in maintaining consistency and uniformity of absorbed dose measurements for precision in dose delivery.

[Limiting factors in the class III camouflage treatment: a potential protocol].

PubMed

Chaques Asensi, José

2016-06-01

The Class III skeletal malocclusion has been traditionally treated with a combined approach of orthodontics and orthognathic surgery or with a strategy of orthodontic camouflage. Some severe cases can be identified as ideal candidates for a surgical treatment whereas some others can be handled with orthodontics alone, with a reasonable expectation of an acceptable result. However, the problem remains for the borderline patient. In fact, limited information is available in the literature regarding the identification of the factors that can help in establishing the limits for one treatment modality or the other. Furthermore, the quantification of some of these factors, for practical purposes, is practically missing or very seldom suggested. Therefore, the decision making process remains a subjective reflection based on the "good clinical sense" of the orthodontist or just reduced to an "educated guess". In order to add some information, hopefully useful in deciding the most suitable treatment option for the individual patient, we propose a clinical protocol based on four different factors. Namely: the skeletal discrepancy, the occlusal discrepancy, the periodontal condition and facial aesthetics. For each one of these factors several parameters will be evaluated and, for some of them, an attempt to provide some reference numerical values will be made. Finally, clinical examples will be presented to illustrate the concepts discussed and the treatment alternatives, final treatment plan and treatment outcome will be analyzed for each one of them. © EDP Sciences, SFODF, 2016.

Clinical field follow-up of high density polyethylene (HDPE)-Jaipur prosthetic technology for trans-tibial amputees.

PubMed

Jensen, J S; Craig, J G; Mtalo, L B; Zelaya, C M

2004-12-01

The purpose of this study was to examine the outcome of the application of the High Density Polyethylene (HDPE)-Jaipur prosthetic construction in fitting trans-tibial amputees in a number of projects in the developing world. Projects in Honduras, Uganda and India were visited. Three hundred and twenty (320) patients had been provided with a HDPE-Jaipur prosthesis and of these 172 were seen for a technical and clinical follow-up after a median of 35 months. More than half the amputations were due to trauma, the remainder to disease. Fabrication and fitting in the three projects was carried out by individuals who had undertaken a twice week training course provided by Bhagwan Mahaveer Viklang Sahayata Samiti limb centre in Jaipur. The individuals involved had limited background training in prosthetics. Craftsmanship and fit were assessed as being poor in 56% of cases. The technical quality of the Jaipur foot was considered acceptable as its performance was better than previously observed results. Although there was patient satisfaction of 85% and compliance of 94% the HDPE-Jaipur trans-tibial system was not considered acceptable as 49% reported walking distances less than 1km and 36% discomfort. The major inadequacy in outcome relates to the use for fabrication and fitting of individuals with inadequate education and training.

Pain experience, expression and coping in boys and young men with Duchenne Muscular Dystrophy - A pilot study using mixed methods.

PubMed

Hunt, Anne; Carter, Bernie; Abbott, Janice; Parker, Arija; Spinty, Stefan; deGoede, Christian

2016-07-01

There is limited research exploring the pain experience of boys and young men with Duchenne Muscular Dystrophy. We conducted a mixed-methods pilot study to assess the feasibility of using particular measures of pain, pain coping and quality of life within semi-structured interviews with boys and young men with Duchenne Muscular Dystrophy and a postal survey of their parents. Non-probability, convenience sampling was used. Twelve young men aged 11-21 years (median 15 years), three of whom were still ambulant, and their parents/guardians were recruited. The measures used were acceptable to the young men and demonstrated potential to provide useful data. Two-thirds of young men suffered from significant daily pain which was associated with reduced quality of life. Pain complaints were largely kept within the family. Young men's pain-coping strategies were limited by their restricted physical abilities. Statistical power based on these preliminary results suggests a study of approximately 50 boys/young men which appears feasible. Further study is needed to explore acceptable and effective methods of pain management in this population and ways of enhancing pain-coping strategies. In clinical practice, assessment of pains and discomfort should form part of all routine consultations. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

Changes in salivary oxytocin after inhalation of clary sage essential oil scent in term-pregnant women: a feasibility pilot study.

PubMed

Tadokoro, Yuriko; Horiuchi, Shigeko; Takahata, Kaori; Shuo, Takuya; Sawano, Erika; Shinohara, Kazuyuki

2017-12-08

This pilot study using a quasi-experimental design was conducted to evaluate the feasibility (i.e., limited efficacy, practicality, and acceptability) of our intervention protocol involving inhalation of the scent of clary sage essential oil by pregnant women and measurement of their preinhalation and postinhalation oxytocin levels. Participants were women of singleton pregnancies between 38 and 40 gestation weeks (N = 11). The experiment group (n = 5) inhaled the scent of clary sage essential oil diluted 50-fold with 10 mL of odorless propylene glycol for 20 min. Regarding limited efficacy, the oxytocin level 15 min postinhalation increased in 3 women and was unmeasurable in 2. The control group (n = 6) inhaled similarly without the 50-fold dilution of clary sage essential oil. Their oxytocin level increased in 2 women, decreased in 2, and was unmeasurable in 2. Uterine contraction was not observed in both groups. Regarding practicality, 3 of the 11 women could not collect sufficient saliva. The cortisol level decreased in both groups postinhalation. The protocol had no negative effects. Regarding acceptability, burden of the protocol was not observed. Trial registration The Clinical Trials Registry of University Hospital Medical Information Network in Japan-UMIN000017830. Registered:  June 8, 2015.

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...

Workplace-based assessment of communication skills: A pilot project addressing feasibility, acceptance and reliability

PubMed Central

Weyers, Simone; Jemi, Iman; Karger, André; Raski, Bianca; Rotthoff, Thomas; Pentzek, Michael; Mortsiefer, Achim

2016-01-01

Background: Imparting communication skills has been given great importance in medical curricula. In addition to standardized assessments, students should communicate with real patients in actual clinical situations during workplace-based assessments and receive structured feedback on their performance. The aim of this project was to pilot a formative testing method for workplace-based assessment. Our investigation centered in particular on whether or not physicians view the method as feasible and how high acceptance is among students. In addition, we assessed the reliability of the method. Method: As part of the project, 16 students held two consultations each with chronically ill patients at the medical practice where they were completing GP training. These consultations were video-recorded. The trained mentoring physician rated the student’s performance and provided feedback immediately following the consultations using the Berlin Global Rating scale (BGR). Two impartial, trained raters also evaluated the videos using BGR. For qualitative and quantitative analysis, information on how physicians and students viewed feasibility and their levels of acceptance was collected in written form in a partially standardized manner. To test for reliability, the test-retest reliability was calculated for both of the overall evaluations given by each rater. The inter-rater reliability was determined for the three evaluations of each individual consultation. Results: The formative assessment method was rated positively by both physicians and students. It is relatively easy to integrate into daily routines. Its significant value lies in the personal, structured and recurring feedback. The two overall scores for each patient consultation given by the two impartial raters correlate moderately. The degree of uniformity among the three raters in respect to the individual consultations is low. Discussion: Within the scope of this pilot project, only a small sample of physicians and students could be surveyed to a limited extent. There are indications that the assessment can be improved by integrating more information on medical context and student self-assessments. Despite the current limitations regarding test criteria, it is clear that workplace-based assessment of communication skills in the clinical setting is a valuable addition to the communication curricula of medical schools. PMID:27990466

Workplace-based assessment of communication skills: A pilot project addressing feasibility, acceptance and reliability.

PubMed

Weyers, Simone; Jemi, Iman; Karger, André; Raski, Bianca; Rotthoff, Thomas; Pentzek, Michael; Mortsiefer, Achim

2016-01-01

Background: Imparting communication skills has been given great importance in medical curricula. In addition to standardized assessments, students should communicate with real patients in actual clinical situations during workplace-based assessments and receive structured feedback on their performance. The aim of this project was to pilot a formative testing method for workplace-based assessment. Our investigation centered in particular on whether or not physicians view the method as feasible and how high acceptance is among students. In addition, we assessed the reliability of the method. Method: As part of the project, 16 students held two consultations each with chronically ill patients at the medical practice where they were completing GP training. These consultations were video-recorded. The trained mentoring physician rated the student's performance and provided feedback immediately following the consultations using the Berlin Global Rating scale (BGR). Two impartial, trained raters also evaluated the videos using BGR. For qualitative and quantitative analysis, information on how physicians and students viewed feasibility and their levels of acceptance was collected in written form in a partially standardized manner. To test for reliability, the test-retest reliability was calculated for both of the overall evaluations given by each rater. The inter-rater reliability was determined for the three evaluations of each individual consultation. Results: The formative assessment method was rated positively by both physicians and students. It is relatively easy to integrate into daily routines. Its significant value lies in the personal, structured and recurring feedback. The two overall scores for each patient consultation given by the two impartial raters correlate moderately. The degree of uniformity among the three raters in respect to the individual consultations is low. Discussion: Within the scope of this pilot project, only a small sample of physicians and students could be surveyed to a limited extent. There are indications that the assessment can be improved by integrating more information on medical context and student self-assessments. Despite the current limitations regarding test criteria, it is clear that workplace-based assessment of communication skills in the clinical setting is a valuable addition to the communication curricula of medical schools.

Ethical issues relating to renal transplantation from prediabetic living donor

PubMed Central

2014-01-01

Background In Mexico, diabetes mellitus is the main cause of end − stage kidney disease, and some patients may be transplant candidates. Organ supply is limited because of cultural issues. And, there is a lack of standardized clinical guidelines regarding organ donation. These issues highlight the tension surrounding the fact that living donors are being selected despite being prediabetic. This article presents, examines and discusses using the principles of non-maleficience, autonomy, justice and the constitutionally guaranteed right to health, the ethical considerations that arise from considering a prediabetic person as a potential kidney donor. Discussion Diabetes is an absolute contraindication for donating a kidney. However, the transplant protocols most frequently used in Mexico do not consider prediabetes as exclusion criteria. In prediabetic persons there are well known metabolic alterations that may compromise the long − term outcomes of the transplant if such donors are accepted. Even so, many of them are finally included because there are not enough donor candidates. Both, families and hospitals face the need to rapidly accept prediabetic donors before the clinical conditions of the recipient and the evolution of the disease exclude him/her as a transplant candidate; however, when using a kidney potentially damaged by prediabetes, neither the donor’s nor the recipient’s long term health is usually considered. Considering the ethical implication as well as the clinical and epidemiological evidence, we conclude that prediabetic persons are not suitable candidates for kidney donation. This recommendation should be taken into consideration by Mexican health institutions who should rewrite their transplant protocols. Summary We argue that the decision to use a kidney from a living donor known to be pre-diabetic or from those persons with family history of T2DM, obesity, hypertension, or renal failure, should be considered unethical in Mexico if the donor bases the decision to donate on socially acceptable norms rather than informed consent as understood in modern medicine. PMID:24935278

Acceptance, Prevalence and Indications for Robot-Assisted Laparoscopy - Results of a Survey Among Urologists in Germany, Austria and Switzerland.

PubMed

Imkamp, Florian; Herrmann, Thomas R W; Tolkach, Yuri; Dziuba, Sebastian; Stolzenburg, Jens U; Rassweiler, Jens; Sulser, Tullio; Zimmermann, Uwe; Merseburger, Axel S; Kuczyk, Markus A; Burchardt, Martin

2015-01-01

Robotic-assisted laparoscopy (RAL) is being widely accepted in the field of urology as a replacement for conventional laparoscopy (CL). Nevertheless, the process of its integration in clinical routines has been rather spontaneous. To determine the prevalence of robotic systems (RS) in urological clinics in Germany, Austria and Switzerland, the acceptance of RAL among urologists as a replacement for CL and its current use for 25 different urological indications. To elucidate the practice patterns of RAL, a survey at hospitals in Germany, Austria and Switzerland was conducted. All surgically active urology departments in Germany (303), Austria (37) and Switzerland (84) received a questionnaire with questions related to the one-year period prior to the survey. The response rate was 63%. Among the participants, 43% were universities, 45% were tertiary care centres, and 8% were secondary care hospitals. A total of 60 RS (Germany 35, Austria 8, Switzerland 17) were available, and the majority (68%) were operated under public ownership. The perception of RAL and the anticipated superiority of RAL significantly differed between robotic and non-robotic surgeons. For only two urologic indications were more than 50% of the procedures performed using RAL: pyeloplasty (58%) and transperitoneal radical prostatectomy (75%). On average, 35% of robotic surgeons and only 14% of non-robotic surgeons anticipated RAL superiority in some of the 25 indications. This survey provides a detailed insight into RAL implementation in Germany, Austria and Switzerland. RAL is currently limited to a few urological indications with a small number of high-volume robotic centres. These results might suggest that a saturation of clinics using RS has been achieved but that the existing robotic capacities are being utilized ineffectively. The possible reasons for this finding are discussed, and certain strategies to solve these problems are offered. © 2015 S. Karger AG, Basel.

Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

PubMed

Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

2018-05-22

Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration number DRKS00010282 .

Ethical issues relating to renal transplantation from prediabetic living donor.

PubMed

Ferreira-Hermosillo, Aldo; Valdez-Martínez, Edith; Bedolla, Miguel

2014-06-16

In Mexico, diabetes mellitus is the main cause of end - stage kidney disease, and some patients may be transplant candidates. Organ supply is limited because of cultural issues. And, there is a lack of standardized clinical guidelines regarding organ donation. These issues highlight the tension surrounding the fact that living donors are being selected despite being prediabetic. This article presents, examines and discusses using the principles of non-maleficience, autonomy, justice and the constitutionally guaranteed right to health, the ethical considerations that arise from considering a prediabetic person as a potential kidney donor. Diabetes is an absolute contraindication for donating a kidney. However, the transplant protocols most frequently used in Mexico do not consider prediabetes as exclusion criteria. In prediabetic persons there are well known metabolic alterations that may compromise the long - term outcomes of the transplant if such donors are accepted. Even so, many of them are finally included because there are not enough donor candidates. Both, families and hospitals face the need to rapidly accept prediabetic donors before the clinical conditions of the recipient and the evolution of the disease exclude him/her as a transplant candidate; however, when using a kidney potentially damaged by prediabetes, neither the donor's nor the recipient's long term health is usually considered.Considering the ethical implication as well as the clinical and epidemiological evidence, we conclude that prediabetic persons are not suitable candidates for kidney donation. This recommendation should be taken into consideration by Mexican health institutions who should rewrite their transplant protocols. We argue that the decision to use a kidney from a living donor known to be pre-diabetic or from those persons with family history of T2DM, obesity, hypertension, or renal failure, should be considered unethical in Mexico if the donor bases the decision to donate on socially acceptable norms rather than informed consent as understood in modern medicine.

Direct-to-consumer genetic testing: an assessment of genetic counselors' knowledge and beliefs

PubMed Central

Hock, Kathryn T.; Christensen, Kurt D.; Yashar, Beverly M.; Roberts, J. Scott; Gollust, Sarah E.; Uhlmann, Wendy R.

2013-01-01

Purpose Direct-to-consumer genetic testing is a new means of obtaining genetic testing outside of a traditional clinical setting. This study assesses genetic counselors’ experience, knowledge, and beliefs regarding direct-to-consumer genetic testing for tests that would currently be offered in genetics clinics. Methods Members of the National Society of Genetic Counselors completed a web-administered survey in February 2008. Results Response rate was 36%; the final data analysis included 312 respondents. Eighty-three percent of respondents had two or fewer inquiries about direct-to-consumer genetic testing, and 14% had received requests for test interpretation or discussion. Respondents believed that genetic counselors have a professional obligation to be knowledgeable about direct-to-consumer genetic testing (55%) and interpret results (48%). Fifty-one percent of respondents thought genetic testing should be limited to a clinical setting; 56% agreed direct-to-consumer genetic testing is acceptable if genetic counseling is provided. More than 70% of respondents would definitely or possibly consider direct-to-consumer testing for patients who (1) have concerns about genetic discrimination, (2) want anonymous testing, or (3) have geographic constraints. Conclusions Results indicate that genetic counselors have limited patient experiences with direct-to-consumer genetic testing and are cautiously considering if and under what circumstances this approach should be used PMID:21233722

A versatile electrophoresis-based self-test platform.

PubMed

Staal, Steven; Ungerer, Mathijn; Floris, Arjan; Ten Brinke, Hans-Willem; Helmhout, Roy; Tellegen, Marian; Janssen, Kjeld; Karstens, Erik; van Arragon, Charlotte; Lenk, Stefan; Staijen, Erik; Bartholomew, Jody; Krabbe, Hans; Movig, Kris; Dubský, Pavel; van den Berg, Albert; Eijkel, Jan

2015-03-01

This paper reports on recent research creating a family of electrophoresis-based point of care devices for the determination of a wide range of ionic analytes in various sample matrices. These devices are based on a first version for the point-of-care measurement of Li(+), reported in 2010 by Floris et al. (Lab Chip 2010, 10, 1799-1806). With respect to this device, significant improvements in accuracy, precision, detection limit, and reliability have been obtained especially by the use of multiple injections of one sample on a single chip and integrated data analysis. Internal and external validation by clinical laboratories for the determination of analytes in real patients by a self-test is reported. For Li(+) in blood better precision than the standard clinical determination for Li(+) was achieved. For Na(+) in human urine the method was found to be within the clinical acceptability limits. In a veterinary application, Ca(2+) and Mg(2+) were determined in bovine blood by means of the same chip, but using a different platform. Finally, promising preliminary results are reported with the Medimate platform for the determination of creatinine in whole blood and quantification of both cations and anions through replicate measurements on the same sample with the same chip. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Evaluating faculty clinical excellence in the academic health sciences center.

PubMed

Carey, R M; Wheby, M S; Reynolds, R E

1993-11-01

Although excellence in the clinical care of patients is the cornerstone of medicine, academic health sciences centers have increasingly given more weight to research and correspondingly less emphasis to patient care. To better recognize and reward clinical excellence, it is first necessary to effectively evaluate physicians' performances in patient care. In addition to addressing the value of faculty clinical excellence in the academic setting, the authors discuss different approaches to clinical assessment, theoretical and practical problems in assessing the performances of clinical faculty, and a system of evaluation being initiated at the University of Virginia School of Medicine. This system of evaluation combines--in annual individual reviews--a limited amount of objective assessment data with subjective evaluations from several sources. The objective data include board certification and recertification, analysis of outcomes data, and documentation of scholarly activity. The subjective evaluations include letters of recognition and appreciation from faculty colleagues and written observations from department chairs, housestaff, students, and nurses. The system has been accepted by department chairs, members of the Promotion and Tenure Committee, and the general faculty. In implementing this new system, periodic review of the pace and direction of change will be crucial to track progress and provide feedback for further modification.

[Radioprotection and environmental pollution by the use of the radionuclides 89Sr, 186Re, and 153Sm for pain palliation in metastatic bone diseases. Related calculations].

PubMed

Sbonias, Evangelos

2005-01-01

Due to the fact that the existing commercial analgesic drugs are not able to reduce effectively the pain caused by the metastatic bone disease, the use of radiopharmaceuticals with avidity to selectively localize in the metastatic skeletal sites, such as strondium-89 chloride (89Sr-Cl2), rhenium-186-hydroxy ethylene diphosphonate (186Re-HEDP), and samarium-153-ethylene diamine tetramethylene (153Sm-EDTMP), is widely accepted. However this medical application may be dangerous for the occupied personnel and more for general public, if radioactive waste is not properly disposed. In the following article we try to estimate the degree and the significance of that risk. For that reason we discuss the physical properties of these radionuclides and their distribution in the body of the patient. We conclude that 89Sr is not harmful for the physician, the attending personnel or those who live with the patient, because it radiates beta-radiation, while its gamma-radiation is negligeable. The radionuclides 186Re and 153Sm besides beta-radiation, also emit a perceptible amount of gamma-radiation. It has been shown that the exposure to gamma-radiation from these radionuclides of the physician, the attending personnel or those who live with the patient is very low as compared to the internationally accepted radioprotection limits. However the environmental contamination per treatment by either of these three radionuclides is not negligeable in comparison to the national and international accepted limits. Patients that are not in good clinical condition may pose an additional contamination danger to those attending them. For limiting radiocontamination, the annual number of treatments by the above three previous radionuclides, should be considered according to the ALARA principle in relation with the correct handling of these patients, and also considering the fundamentals of radioprotection.

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.

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.

Accuracy, reliability, and efficiency of intraoral scanners for full-arch impressions: a systematic review of the clinical evidence.

PubMed

Goracci, Cecilia; Franchi, Lorenzo; Vichi, Alessandro; Ferrari, Marco

2016-08-01

The interest on intraoral scanners for digital impressions has been growing and new devices are continuously introduced on the market. It is timely to verify whether the several scanners proposed for full-arch digital impressions have been tested under clinical conditions for validity, repeatability, reproducibility, as well as for time efficiency, and patient acceptance. An electronic search of the literature was conducted through PubMed, Scopus, Cochrane Library, Web of Science, and Embase, entering the query terms 'digital impression', 'intraoral digital impression', 'intraoral scanning', 'intraoral scanner', 'intraoral digital scanner', combined by the Boolean operator 'OR'. No language or time limitation was applied. Only studies where digital full-arch impressions had been recorded intraorally were considered. In only eight studies full-arch scans had been performed intraorally. Only four studies reported data on validity, repeatability, reproducibility of digital measurements and their samples were limited to subjects in complete permanent dentition. Only two intraoral scanners, Lava COS and iTero, were tested. Scanning times were measured in six studies and varied largely. Patients' acceptance of intraoral scanning was evaluated in four studies, but it was not specifically assessed for children. The scientific evidence so far collected on intraoral scanning is neither exhaustive, nor up-to-date. Data from full-arch scans performed in children should be collected. For a meaningful assessment of time efficiency, agreement should be reached on the procedural steps to be included in the computation of scanning time. © The Author 2015. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

PubMed

Lexchin, J; Holbrook, A

1994-07-01

To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). Analytic study. All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion.

Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

PubMed Central

2014-01-01

Background Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required. PMID:24628821

Methodologic quality and relevance of references in pharmaceutical advertisements in a Canadian medical journal.

PubMed Central

Lexchin, J; Holbrook, A

1994-01-01

OBJECTIVE: To evaluate the methodologic quality and relevance of references in pharmaceutical advertisements in the Canadian Medical Association Journal (CMAJ). DESIGN: Analytic study. DATA SOURCE: All 114 references cited in the first 22 distinct pharmaceutical advertisements in volume 146 of CMAJ. MAIN OUTCOME MEASURES: Mean methodologic quality score (modified from the 6-point scale used to assess articles in the American College of Physicians' Journal Club) and mean relevance score (based on a new 5-point scale) for all references in each advertisement. MAIN RESULTS: Twenty of the 22 companies responded, sending 78 (90%) of the 87 references requested. The mean methodologic quality score was 58% (95% confidence limits [CL] 51% and 65%) and the mean relevance score 76% (95% CL 72% and 80%). The two mean scores were statistically lower than the acceptable score of 80% (p < 0.05), and the methodologic quality score was outside the preset clinically significant difference of 15%. The poor rating for methodologic quality was primarily because of the citation of references to low-quality review articles and "other" sources (i.e., other than reports of clinical trials). Half of the advertisements had a methodologic quality score of less than 65%, but only five had a relevance score of less than 65%. CONCLUSIONS: Although the relevance of most of the references was within minimal acceptable limits, the methodologic quality was often unacceptable. Because advertisements are an important part of pharmaceutical marketing and education, we suggest that companies develop written standards for their advertisements and monitor their advertisements for adherence to these standards. We also suggest that the Pharmaceutical Advertising Advisory Board develop more stringent guidelines for advertising and that it enforce these guidelines in a consistent, rigorous fashion. PMID:8004560

Acceptability and Feasibility of Real-Time Antiretroviral Therapy Adherence Interventions in Rural Uganda: Mixed-Method Pilot Randomized Controlled Trial

PubMed Central

Atukunda, Esther C; Tumuhimbise, Wilson; Pisarski, Emily E; Tam, Melanie; Wyatt, Monique A; Ware, Norma C; Haberer, Jessica E

2018-01-01

Background Wireless electronic adherence monitors can detect antiretroviral therapy (ART) adherence lapses and trigger interventions in real time, thus potentially avoiding unnecessary HIV viremia. Evidence about the acceptability and feasibility of these monitors and associated interventions, however, is limited. Objective The aim of this study was to assess the acceptability and feasibility of real-time adherence monitoring linked to text messaging (short message service, SMS) reminders and notifications to support adherence among individuals living with HIV who are taking ART in rural southwestern Uganda. Methods Individuals living with HIV who were initiating ART were enrolled in a pilot randomized controlled trial and followed up for 9 months. Participants received a real-time adherence monitor and were randomized to one of the following study arms: (1) scheduled SMS, (2) SMS triggered by missed or delayed doses, or (3) no SMS. SMS notifications were also sent to 45 patient-identified social supporters for sustained adherence lapses in the scheduled SMS and triggered SMS arms. Study participants and social supporters participated in qualitative semistructured in-depth interviews on acceptability and feasibility of this technology. An inductive, content analytic approach, framed by the unified theory of acceptance and use of technology model, was used to analyze qualitative data. Quantitative feasibility data, including device functionality and SMS tracking data, were recorded based upon device metrics collected electronically and summarized descriptively. Results A total of 63 participants participated in the study. Participants reported that real-time monitoring intervention linked to SMS reminders and notifications are generally acceptable; the predominant feedback was perceived utility—the intervention was beneficial in motivating and reminding patients to take medication, as well as enabling provision of social support. The intervention was found to be technically feasible, as data were obtained from most participants as expected most of the time. Potential challenges included the impact of the technology on confidentiality, shared phone ownership, usability skills, and availability of electricity. Conclusions Real-time adherence monitoring integrated with SMS reminders and social support notifications is a generally acceptable (based primarily on perceived utility) and feasible intervention in a resource-limited country. Future efforts should focus on optimized device design, user training to overcome the challenges we encountered, cost effectiveness studies, as well as studying the monitoring aspect of the device without accompanying interventions. Trial Registration ClinicalTrials.gov NCT01957865; https://clinicaltrials.gov/ct2/show/NCT01957865 (Archived by WebCite at http://www.webcitation.org/6zFiDlXDa) PMID:29773527

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.

Virtual reality exposure-based therapy for the treatment of post-traumatic stress disorder: a review of its efficacy, the adequacy of the treatment protocol, and its acceptability

PubMed Central

Botella, Cristina; Serrano, Berenice; Baños, Rosa M; Garcia-Palacios, Azucena

2015-01-01

Introduction The essential feature of post-traumatic stress disorder (PTSD) is the development of characteristic symptoms following exposure to one or more traumatic events. According to evidence-based intervention guidelines and empirical evidence, one of the most extensively researched and validated treatments for PTSD is prolonged exposure to traumatic events; however, exposure therapy can present some limitations. Virtual reality (VR) can help to improve prolonged exposure because it creates fictitious, safe, and controllable situations that can enhance emotional engagement and acceptance. Objective In addition to carrying out a review to evaluate the efficacy of VR exposure-based therapy (VR-EBT) for the treatment of PTSD, the aim of this study was to contribute to analyzing the use of VR-EBT by: first, evaluating the adequacy of psychological treatment protocols that use VR-EBT to treat PTSD; and second, analyzing the acceptability of VR-EBT. Method We performed a replica search with descriptors and databases used in two previous reviews and updated to April 2015. Next, we carried out an evaluation of the efficacy, adequacy, and acceptability of VR-EBT protocols. Results Results showed that VR-EBT was effective in the treatment of PTSD. The findings related to adequacy showed that not all studies using VR-EBT reported having followed the clinical guidelines for evidence-based interventions in the treatment of PTSD. Regarding acceptability, few studies evaluated this subject. However, the findings are very promising, and patients reported high acceptability and satisfaction with the inclusion of VR in the treatment of PTSD. Conclusion The main weaknesses identified in this review focus on the need for more controlled studies, the need to standardize treatment protocols using VR-EBT, and the need to include assessments of acceptability and related variables. Finally, this paper highlights some directions and future perspectives for using VR-EBT in PTSD treatment. PMID:26491332

Editorial Commentary: The Acellular Osteochondral Allograft, the Emperor Has New Clothes.

PubMed

Mandelbaum, Bert R; Chahla, Jorge

2017-12-01

For larger lesions (>2.5-cm 2 ), clinical evidence and practice have shown that fresh osteochondral allograft have good durability, with 88% return to sport and greater than 75% 10-year survival rates for treatment of large femoral condyle lesions. That said, the use of fresh osteochondral allografts in clinical practice is limited by the availability of acceptable donor tissues for eligible patients in a timely fashion. Significant diminution of chondrocyte viability and density occurs during the preservation and storage period. All osteochondral allografts are not equal in performance and outcome. Chondrocyte density and viability are critical for successful transplantation and outcome in the short and long term. This commentary highlights the high failure rates of tissue when it is acellular. Copyright © 2017 Arthroscopy Association of North America. Published by Elsevier Inc. All rights reserved.

Imaging of inflammatory processes with labeled cells

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

Froelich, J.W.; Swanson, D.

1984-04-01

Radionuclide techniques for localizing inflammatory processes had relied heavily upon /sup 67/Ga-citrate until McAfee and Thakur described the technique for the radiolabeling of leukocytes with /sup 111/In-oxine. Since their initial description in 1976 there has been continued development of the radiopharmaceutical, as well as clinical efficacy. At present /sup 111/In-labeled leukocytes continue to be handled as an investigational new drug but this has not greatly limited its clinical availability. Indium-/sup 111/ leukocytes are the agent of choice for evaluation of patients with fever of unknown origin, osteomyelitis, and prosthetic graft infections; and preliminary data shows great promise in the areamore » of detecting reoccurrence of inflammatory bowel disease. This article attempts to review currently accepted uses of 111In leukocytes as well as potential areas of application.« less

The main challenges that remain in applying high-throughput sequencing to clinical diagnostics.

PubMed

Loeffelholz, Michael; Fofanov, Yuriy

2015-01-01

Over the last 10 years, the quality, price and availability of high-throughput sequencing instruments have improved to the point that this technology may be close to becoming a routine tool in the diagnostic microbiology laboratory. Two groups of challenges, however, have to be resolved in order to move this powerful research technology into routine use in the clinical microbiology laboratory. The computational/bioinformatics challenges include data storage cost and privacy concerns, requiring analysis to be performed without access to cloud storage or expensive computational infrastructure. The logistical challenges include interpretation of complex results and acceptance and understanding of the advantages and limitations of this technology by the medical community. This article focuses on the approaches to address these challenges, such as file formats, algorithms, data collection, reporting and good laboratory practices.

Echocardiography for Intraoperative Decision Making in Mitral Valve Surgery-A Pilot Simulation-Based Training Module.

PubMed

Morais, Rex Joseph; Ashokka, Balakrishnan; Paranjothy, Suresh; Siau, Chiang; Ti, Lian Kah

2017-10-01

Echocardiographic assessment of the repaired or replaced mitral valve intraoperatively involves making a high-impact joint decision with the surgeon, in a time-sensitive manner, in a dynamic clinical situation. These decisions have to take into account the degree of imperfection if any, the likelihood of obtaining a better result, the underlying condition of the patient, and the impact of a longer cardiopulmonary bypass period if the decision is made to reintervene. Traditional echocardiography teaching is limited in its ability to provide this training. The authors report the development and implementation of a training module simulating the dynamic clinical environment of a mitral valve surgery in progress and the critical echo-based intraoperative decision making involved in the assessment of the acceptability of the surgical result. Copyright © 2017 Elsevier Inc. All rights reserved.

Shared decision-making in epilepsy management.

PubMed

Pickrell, W O; Elwyn, G; Smith, P E M

2015-06-01

Policy makers, clinicians, and patients increasingly recognize the need for greater patient involvement in clinical decision-making. Shared decision-making helps address these concerns by providing a framework for clinicians and patients to make decisions together using the best evidence. Shared decision-making is applicable to situations where several acceptable options exist (clinical equipoise). Such situations occur commonly in epilepsy, for example, in decisions regarding the choice of medication, treatment in pregnancy, and medication withdrawal. A talk model is a way of implementing shared decision-making during consultations, and decision aids are useful tools to assist in the process. Although there is limited evidence available for shared decision-making in epilepsy, there are several benefits of shared decision-making in general including improved decision quality, more informed choices, and better treatment concordance. Copyright © 2015 Elsevier Inc. All rights reserved.

Measurement of HbA1c in multicentre diabetes trials - should blood samples be tested locally or sent to a central laboratory: an agreement analysis.

PubMed

Arch, Barbara N; Blair, Joanne; McKay, Andrew; Gregory, John W; Newland, Paul; Gamble, Carrol

2016-10-24

Glycated haemoglobin (HbA1c) is an important outcome measure in diabetes clinical trials. For multicentre designs, HbA1c can be measured locally at participating centres or by sending blood samples to a central laboratory. This study analyses the agreement between local and central measurements, using 1-year follow-up data collected in a multicentre randomised controlled trial (RCT) of newly diagnosed children with type I diabetes. HbA1c measurements were routinely analysed both locally and centrally at baseline and then at 3, 6, 9 and 12 months and the data reported in mmol/mol. Agreement was assessed by calculating the bias and 95 % limits of agreement, using the Bland-Altman analysis method. A predetermined benchmark for clinically acceptable margin of error between measurements was subjectively set as ±10 % for HbA1c. The percentage of pairs of measurements that were classified as clinically acceptable was calculated. Descriptive statistics were used to examine the agreement within centres. Treatment group was not considered. Five hundred and ninety pairs of measurement, representing 255 children and 15 trial centres across four follow-up time points, were compared. There was no significant bias: local measurements were an average of 0.16 mmol/mol (SD = 4.5, 95 % CI -0.2 to 0.5) higher than central. The 95 % limits of agreement were -8.6 to 9.0 mmol/mol (local minus central). Eighty percent of local measurements were within ±10 % of corresponding central measurements. Some trial centres were more varied in the differences observed between local and central measurements: IQRs ranging from 3 to 9 mmol/mol; none indicated systematic bias. Variation in agreement between HbA1c measurements was greater than had been expected although no overall bias was detected and standard deviations were similar. Discrepancies were present across all participating centres. These findings have implications for the comparison of standards of clinical care between centres, the design of future multicentre RCTs and existing quality assurance processes for HbA1c measurements. We recommend that centralised HbA1c measurement is preferable in the multicentre clinical trial setting. Eudract No. 2010-023792-25 , registered on 4 November 2010.

Proceedings - Limits of Acceptable Change and related planning processes: Progress and future directions

Treesearch

Stephen F. McCool; David N. Cole

1997-01-01

Experience with Limits of Acceptable Change (LAC) and related planning processes has accumulated since the mid-1980's. These processes were developoed as a means of dealing with recreation carrying capacity issues in wilderness and National Parks. These processes clearly also have application outside of protected areas and to issues other than recreation...

Low Cost Comprehensive Microcomputer-Based Medical History Database Acquisition

PubMed Central

Buchan, Robert R. C.

1980-01-01

A carefully detailed, comprehensive medical history database is the fundamental essence of patient-physician interaction. Computer generated medical history acquisition has repeatedly been shown to be highly acceptable to both patient and physician while consistantly providing a superior product. Cost justification of machine derived problem and history databases, however, has in the past been marginal, at best. Routine use of the technology has therefore been limited to large clinics, university hospitals and federal installations where feasible volume applications are supported by endowment, research funds or taxes. This paper summarizes the use of a unique low cost device which marries advanced microprocessor technology with random access, variable-frame film projection techniques to acquire a detailed comprehensive medical history database. Preliminary data are presented which compare patient, physician, and machine generated histories for content, discovery, compliance and acceptability. Results compare favorably with the findings in similar studies by a variety of authors. ImagesFigure 1Figure 2Figure 3Figure 4

The problem of IVF cost in developing countries: has natural cycle IVF a place?

PubMed

Shahin, Ahmed Y

2007-07-01

Infertility represents a national health problem in some African countries. Limited financial health resources in developing countries are a major obstacle facing infertility management. IVF is the definitive line of treatment for many couples. Stimulation cycles are associated with risks of ovarian hyperstimulation syndrome and multiple pregnancy. This study evaluates the client acceptability of stimulated versus natural cycle IVF among couples attending one infertility clinic, with respect to cost and pregnancy outcome. Of the patients who were indicated for IVF, 15% (16/107) cancelled, due mostly (12/16, 75%) to financial reasons. The majority of patients who completed their IVF treatment (82/91, 90.1%) felt the price of the medical service offered was high, and 68.1% (62/91) accepted the idea of having cheaper drugs with fewer side effects but with possibly lower chances of pregnancy. Natural cycle IVF has emerged as a potential option that might be suitable for patients worldwide, especially in developing countries.

Strategies to optimize the use of marginal donors in liver transplantation

PubMed Central

Pezzati, Daniele; Ghinolfi, Davide; De Simone, Paolo; Balzano, Emanuele; Filipponi, Franco

2015-01-01

Liver transplantation is the treatment of choice for end stage liver disease, but availability of liver grafts is still the main limitation to its wider use. Extended criteria donors (ECD) are considered not ideal for several reasons but their use has dramatically grown in the last decades in order to augment the donor liver pool. Due to improvement in surgical and medical strategies, results using grafts from these donors have become acceptable in terms of survival and complications; nevertheless a big debate still exists regarding their selection, discharge criteria and allocation policies. Many studies analyzed the use of these grafts from many points of view producing different or contradictory results so that accepted guidelines do not exist and the use of these grafts is still related to non-standardized policies changing from center to center. The aim of this review is to analyze every step of the donation-transplantation process emphasizing all those strategies, both clinical and experimental, that can optimize results using ECD. PMID:26609341

A compact in vivo neutron activation analysis system to quantify manganese in human hand bone

NASA Astrophysics Data System (ADS)

Liu, Yingzi

As an urgent issue of correlating cumulative manganese (Mn) exposure to neurotoxicity, bone has emerged as an attractive biomarker for long-term Mn deposition and storage. A novel Deuterium-Deuterium (DD) neutron generator irradiation system has been simulated and constructed, incorporating moderator, reflector and shielding. This neutron activation analysis (NAA) irradiation assembly presents several desirable features, including high neutron flux, improved detection limit and acceptable neutron & photon dose, which would allow it be ready for clinical measurement. Key steps include simulation modeling and verifying, irradiation system design, detector characterization, and neutron flux and dose assessment. Activation foils were also analyzed to reveal the accurate neutron spectrum in the irradiation cave. The detection limit with this system is 0.428 ppm with 36 mSv equivalent hand dose and 52 microSv whole body effective dose.

A Review of Complementary and Alternative Treatments for Autism Spectrum Disorders

PubMed Central

Lofthouse, Nicholas; Hendren, Robert; Hurt, Elizabeth; Arnold, L. Eugene; Butter, Eric

2012-01-01

Given the severe and chronic problems associated with Autism Spectrum Disorders (ASD) and the limitations of available treatments, there exists a large public health need for additional interventions. As more parents are inquiring about complementary and alternative treatments (CATs), both parents and practitioners require up-to-date information about them and whether and how to integrate them into treatment. After presenting data on CAT usage patterns for ASD, we review 13 ingestible (i.e., orally administered) and 6 noningestible (i.e., externally administered) CATs for ASD. For each CAT we briefly describe its definition; rationale for use; current research support, limitations, and future directions; safety issues; and whether we currently recommend, not recommend, or find it acceptable for the treatment of ASD. We conclude this paper with recommendations for future research and ten clinical recommendations for practitioners. PMID:23243505

The effectiveness of mindfulness-based interventions for supporting people with intellectual disabilities: a narrative review.

PubMed

Harper, Sarah K; Webb, Thomas L; Rayner, Kelly

2013-05-01

A number of studies have used mindfulness-based interventions to influence the behavior of people with intellectual disabilities, to improve their quality of life, and to reduce challenging behavior. The present review critically evaluates 18 studies and assesses the clinical and academic impact of their findings. Strengths identified included replicable methodological approaches, use of multiple baseline designs, strong construct and criterion validity, and consideration of the mechanisms by which mindfulness influences behavior change. Limitations included a lack of randomized controlled trials, inclusion of qualitative data without structured analysis, limited use of statistical analyses, and problems with sampling leading to difficulties generalizing findings. There was also a paucity of research investigating the impact of "Dialectical Behavior Therapy" and "Acceptance and Commitment Therapy" and the role of mindfulness within these approaches. Further research is warranted in this regard.

Post-standardization of routine creatinine assays: are they suitable for clinical applications.

PubMed

Jassam, Nuthar; Weykamp, Cas; Thomas, Annette; Secchiero, Sandra; Sciacovelli, Laura; Plebani, Mario; Thelen, Marc; Cobbaert, Christa; Perich, Carmen; Ricós, Carmen; Paula, Faria A; Barth, Julian H

2017-05-01

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based.

12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

Code of Federal Regulations, 2011 CFR

2011-01-01

... acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller's manual 7.7420. Therefore, national banks are authorized by the Comptroller to make acceptances under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of...

12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

Code of Federal Regulations, 2013 CFR

2013-01-01

..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

Code of Federal Regulations, 2010 CFR

2010-01-01

... acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller's manual 7.7420. Therefore, national banks are authorized by the Comptroller to make acceptances under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of...

12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

Code of Federal Regulations, 2012 CFR

2012-01-01

..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

12 CFR 250.163 - Inapplicability of amount limitations to “ineligible acceptances.”

Code of Federal Regulations, 2014 CFR

2014-01-01

..., since the making of acceptances is an essential part of banking authorized by 12 U.S.C. 24.” Comptroller... under 12 U.S.C. 24, although the acceptances are not the type described in section 13 of the Federal Reserve Act. (c) A review of the legislative history surrounding the enactment of the acceptance...

Clinical Implementation of Pharmacogenomics for Personalized Precision Medicine: Barriers and Solutions.

PubMed

Klein, Michelle E; Parvez, Md Masud; Shin, Jae-Gook

2017-09-01

Clinical implementation of pharmacogenomics (PGx) leads to personalized medicine, which improves the efficacy, safety, and cost-effectiveness of treatments. Although PGx-based research has been conducted for more than a decade, several barriers have slowed down its widespread implementation in clinical practice. Globally, there is an imbalance in programs and solutions required to empower the clinical implementation of PGx between countries. Therefore, we aimed to review these issues comprehensively, determine the major barriers, and find the best solutions. Through an extensive review of ongoing clinical implementation programs, scientific, educational, ethical, legal, and social issues, information technology, and reimbursement were identified as the key barriers. The pace of global implementation of genomic medicine coincided with the resource limitations of each country. The key solutions identified for the earlier mentioned barriers are as follows: building of secure and suitable information technology infrastructure with integrated clinical decision support systems along with increasing PGx evidence, more regulations, reimbursement strategies for stakeholder's acceptance, incorporation of PGx education in all institutions and clinics, and PGx promotion to all health care professionals and patients. In conclusion, this review will be helpful for the better understanding of common barriers and solutions pertaining to the clinical application of PGx. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Implementing and sustaining a mobile medical clinic for prenatal care and sexually transmitted infection prevention in rural Mysore, India.

PubMed

Kojima, Noah; Krupp, Karl; Ravi, Kavitha; Gowda, Savitha; Jaykrishna, Poornima; Leonardson-Placek, Caitlyn; Siddhaiah, Anand; Bristow, Claire C; Arun, Anjali; Klausner, Jeffrey D; Madhivanan, Purnima

2017-03-06

In rural India, mobile medical clinics are useful models for delivering health promotion, education, and care. Mobile medical clinics use fewer providers for larger catchment areas compared to traditional clinic models in resource limited settings, which is especially useful in areas with shortages of healthcare providers and a wide geographical distribution of patients. From 2008 to 2011, we built infrastructure to implement a mobile clinic system to educate rural communities about maternal child health, train community health workers in common safe birthing procedures, and provide comprehensive antenatal care, prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV), and testing for specific infections in a large rural catchment area of pregnant women in rural Mysore. This was done using two mobile clinics and one walk-in clinic. Women were tested for HIV, hepatitis B, syphilis, and bacterial vaginosis along with random blood sugar, urine albumin, and anemia. Sociodemographic information, medical, and obstetric history were collected using interviewer-administered questionnaires in the local language, Kannada. Data were entered in Microsoft Excel and analyzed using Stata SE 14.1. During the program period, nearly 700 community workers and 100 health care providers were trained; educational sessions were delivered to over 15,000 men and women and integrated antenatal care and HIV/sexually transmitted infection testing was offered to 3545 pregnant women. There were 22 (0.6%) cases of HIV, 19 (0.5%) cases of hepatitis B, 2 (0.1%) cases of syphilis, and 250 (7.1%) cases of BV, which were identified and treated. Additionally, 1755 (49.5%) cases of moderate to severe anemia and 154 (4.3%) cases of hypertension were identified and treated among the pregnant women tested. Patient-centered mobile medical clinics are feasible, successful, and acceptable models that can be used to provide quality healthcare to pregnant women in rural and hard-to-reach settings. The high numbers of pregnant women attending mobile medical clinics show that integrated antenatal care with PMTCT services were acceptable and utilized. The program also developed and trained health professionals who continue to remain in those communities.

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.

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

PubMed Central

Kraybill, Ashley; Dember, Laura M.; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S.; Madden, Vanessa; Halpern, Scott D.

2016-01-01

Background Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. Results A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients’ concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Conclusions This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials. PMID:27833931

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care.

PubMed

Kraybill, Ashley; Dember, Laura M; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S; Madden, Vanessa; Halpern, Scott D

2016-01-01

Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

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

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.

Breath Analysis in Disease Diagnosis: Methodological Considerations and Applications

PubMed Central

Lourenço, Célia; Turner, Claire

2014-01-01

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. “Breath fingerprinting”, indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles. PMID:24957037

Breath analysis in disease diagnosis: methodological considerations and applications.

PubMed

Lourenço, Célia; Turner, Claire

2014-06-20

Breath analysis is a promising field with great potential for non-invasive diagnosis of a number of disease states. Analysis of the concentrations of volatile organic compounds (VOCs) in breath with an acceptable accuracy are assessed by means of using analytical techniques with high sensitivity, accuracy, precision, low response time, and low detection limit, which are desirable characteristics for the detection of VOCs in human breath. "Breath fingerprinting", indicative of a specific clinical status, relies on the use of multivariate statistics methods with powerful in-built algorithms. The need for standardisation of sample collection and analysis is the main issue concerning breath analysis, blocking the introduction of breath tests into clinical practice. This review describes recent scientific developments in basic research and clinical applications, namely issues concerning sampling and biochemistry, highlighting the diagnostic potential of breath analysis for disease diagnosis. Several considerations that need to be taken into account in breath analysis are documented here, including the growing need for metabolomics to deal with breath profiles.

Implementation of a pharmacist-led antimicrobial management team in a community teaching hospital: use of pharmacy residents and pharmacy students in a prospective audit and feedback approach.

PubMed

Laible, Brad R; Nazir, Jawad; Assimacopoulos, Aris P; Schut, Jennifer

2010-12-01

Antimicrobial stewardship is an important process proven to combat antimicrobial resistance, improve patient outcomes, and reduce costs. The Infectious Diseases Society of America (IDSA) and the Society for Healthcare Epidemiology of America (SHEA) have provided guidelines for the provision of antimicrobial stewardship. According to these recommendations, antimicrobial stewardship teams should be multidisciplinary in nature, with core members consisting of an infectious disease physician and an infectious disease-trained clinical pharmacist. Due to limited resources, our institution chose to implement a pharmacist-led antimicrobial stewardship service on 1 medical/surgical ward, with the existing clinical pharmacist and 3 infectious disease physicians as core members. This clinical pharmacist was not trained in infectious disease specialty, and stewardship activities were only one part of his daily activities. Pharmacy residents and students were extensively utilized to assist in the stewardship process. Approximately two thirds of stewardship recommendations were accepted using primarily a prospective audit and feedback approach.

Dyshormonia Iatrogenica: crossroads of medicine, malpractice law, and professional ethics in clinical endocrinology.

PubMed

Goldberg, Philip A; Varriale, David J; Mercurio, Mark R

2012-01-01

To present 2 challenging cases of patients who request endocrine therapies that their physician considers to be outside of the standard of care. With these complex cases as a backdrop, we explore the constructs of medicine, malpractice law, and professional ethics that guide physicians' medical decision-making processes. These cases illustrate a common conundrum for clinical endocrinologists, who often find themselves struggling to balance patient satisfaction and well-being with generally accepted standards of medical care. From the perspective of a malpractice lawyer, we review the keys to limiting medicolegal liability, with emphasis on thorough documentation, informed consent, and effective doctor-patient communication. We then review the constructs of professional ethics that guide patient care, with emphasis on virtues of the "good physician," patients' right to self-determination, and paternalism. Finally, we explore some justifications for a compassionate physician to refuse a patient's desired treatment plan. In the end, we hope that this manuscript helps to facilitate best medical, legal, professional, and ethical practices of clinical endocrinology.

Fallibility: a new perspective on the ethics of clinical trial enrollment.

PubMed

Shamy, Michel C F; Stahnisch, Frank W; Hill, Michael D

2015-01-01

The ethical principle of 'equipoise', introduced in 1974, represents the most widely influential justification for the enrollment of patients into randomized clinical trials. However, definitions of equipoise vary, and its terms are not universally accepted. In this paper, we suggest a new way of approaching the ethics of clinical trial enrollment, which we call fallibility. The principle of fallibility argues that all physician opinions are sufficiently uncertain to warrant investigation, and that the ethical justification for any trial becomes a question of its epistemic validity, by which we mean the strength of its hypotheses and methods. The principle of fallibility can be translated into practice through the virtues of humility, skepticism and caring. While we cite recent examples from stroke medicine to demonstrate the limitations of equipoise, we propose that fallibility may offer a more general means of addressing the controversies that arise surrounding randomized controlled trials in many disciplines of medicine. © 2014 World Stroke Organization.

Monitoring the effectiveness of HIV and STI prevention initiatives in England, Wales, and Northern Ireland: where are we now?

PubMed Central

Brown, A E; Tomkins, S E; Logan, L E; LaMontagne, D S; Munro, H L; Hope, V D; Righarts, A; Blackham, J E; Rice, B D; Chadborn, T R; Tookey, P A; Parry, J V; Delpech, V; Gill, O N; Fenton, K A

2006-01-01

Primary and secondary prevention are essential components of the response to HIV and sexually transmitted infections (STIs). We present findings from nationally implemented HIV/STI prevention interventions. In 2003, of those attending STI clinics at least 64% of men who have sex with men (MSM) and 55% of heterosexuals accepted a confidential HIV test; 88% of all HIV infections in women giving birth in England were diagnosed before delivery; 85% of MSM eligible for hepatitis B vaccination received a first dose of vaccine at their first STI clinic attendance; 74% of STI clinic attendees for emergency appointments, and 20% of those for routine appointments were seen within 48 hours of initiating an appointment; the National Chlamydia Screening Programme in England found a positivity of 10% and 13% among young asymptomatic women and men, respectively. Prevention initiatives have seen recent successes in limiting further HIV/STI transmission. However, more work is required if current levels of transmission are to be reduced. PMID:16461593

Psychometric characteristics of the BRIEF scale for the assessment of executive functions in Spanish clinical population.

PubMed

García Fernández, Trinidad; González-Pienda, Julio Antonio; Rodríguez Pérez, Celestino; Álvarez García, David; Álvarez Pérez, Luis

2014-01-01

The Behavior Rating Inventory of Executive Functions (BRIEF) scale, completed by families, is widely known in the assessment of executive functions in children and adolescents. However, its application is limited to English-speaking population. This study analyzes the preliminary results from its application in a Spanish clinical sample, comprising 125 participants aged 5-18 years. Internal structure and reliability of the translated scale were analyzed, as well as its relationship with other behavioral measures through the analysis of their correlations with the Assessment of Attention Deficit Hyperactivity Disorder Scale (EDAH). The results were compared with those from the original validation study. The data revealed the presence of the same internal structure, as well as acceptable internal consistency and significant correlations with the Attention Deficit and Hyperactivity components of the EDAH scale. This study provides preliminary evidence of the utility of the BRIEF scale in cultural contexts different from the original, particularly in Spanish clinical population.

Fit for purpose: perspectives on rapid reviews from end-user interviews.

PubMed

Hartling, Lisa; Guise, Jeanne-Marie; Hempel, Susanne; Featherstone, Robin; Mitchell, Matthew D; Motu'apuaka, Makalapua L; Robinson, Karen A; Schoelles, Karen; Totten, Annette; Whitlock, Evelyn; Wilt, Timothy J; Anderson, Johanna; Berliner, Elise; Gozu, Aysegul; Kato, Elisabeth; Paynter, Robin; Umscheid, Craig A

2017-02-17

There is increasing demand for rapid reviews and timely evidence synthesis. The goal of this project was to understand end-user perspectives on the utility and limitations of rapid products including evidence inventories, rapid responses, and rapid reviews. Interviews were conducted with key informants representing: guideline developers (n = 3), health care providers/health system organizations (n = 3), research funders (n = 1), and payers/health insurers (n = 1). We elicited perspectives on important characteristics of systematic reviews, acceptable methods to streamline reviews, and uses of rapid products. We analyzed content of the interview transcripts and identified themes and subthemes. Key informants identified the following as critical features of evidence reviews: (1) originating from a reliable source (i.e., conducted by experienced reviewers from an established research organization), (2) addressing clinically relevant questions, and (3) trusted relationship between the user and producer. Key informants expressed strong preference for the following review methods and characteristics: use of evidence tables, quality rating of studies, assessments of total evidence quality/strength, and use of summary tables for results and conclusions. Most acceptable trade-offs to increase efficiencies were limiting the literature search (e.g., limiting search dates or language) and performing single screening of citations and full texts for relevance. Key informants perceived rapid products (particularly evidence inventories and rapid responses) as useful interim products to inform downstream investigation (e.g., whether to proceed with a full review or guideline, direction for future research). Most key informants indicated that evidence analysis/synthesis and quality/strength of evidence assessments were important for decision-making. They reported that rapid reviews in particular were useful for guideline development on narrow topics, policy decisions when a quick turn-around is needed, decision-making for practicing clinicians in nuanced clinical settings, and decisions about coverage by payers/health insurers. Rapid reviews may be more relevant within specific clinical settings or health systems; whereas, broad/national guidelines often need a traditional systematic review. Key informants interviewed in our study indicated that evidence inventories, rapid responses, and rapid reviews have utility in specific decisions and contexts. They indicated that the credibility of the review producer, relevance of key questions, and close working relationship between the end-user and producer are critical for any rapid product. Our findings are limited by the sample size which may have been too small to reach saturation for the themes described.

A survey of the use of text messaging for communication with partners in the process of provider-led partner notification.

PubMed

Gilbart, Victoria Louise; Town, Katy; Lowndes, Catherine Mary

2015-03-01

Partner notification (PN) is important for sexually transmitted infection (STI) control. With developments in technology, such as text messaging, contacting partners is now easier. This study investigates the frequency and acceptability of text messaging in UK sexual health clinics for STI provider-led PN. A questionnaire was distributed to health advisers (HAs), cascaded by the Society of Sexual Health Advisers and posted on their website. 65 questionnaires were returned. Most HAs use telephone for the first and second provider-led PN attempt (61, 94% and 51, 78%, respectively) with text messaging as preferred second choice (19, 29% and 32, 49%, respectively). Overall, 56 clinics (86%) used text messaging at some stage, even if not the preferred option. 29 (52%) clinics had text messaging guidelines and 31 (55%) used messaging templates. Messages varied; 33 (59%) request partner make contact, 11 (20%) mention risk of infection, 9 (16%) name the infection and 20 (36%) use a combination of messages. Six (10%) had contact with their Caldicott Guardian about text messaging. No confidentiality concerns were reported and no complaints were reported from partners about receiving unsolicited text messages. Text messaging is widely used and is an important and acceptable tool for STI provider-led PN. It is the second preferred method for contacting partners after telephone for first and second provider-led PN attempts. A small number of clinics never use it. Message content varied; few named the infection. Concerns about confidentiality or negative impact for the partner were not reported. National guidance for the use of text messaging for provider-led PN is needed. 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.

Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

PubMed

Kemp, Robert; Prasad, Vinay

2017-07-21

Surrogate outcomes are not intrinsically beneficial to patients, but are designed to be easier and faster to measure than clinically meaningful outcomes. The use of surrogates as an endpoint in clinical trials and basis for regulatory approval is common, and frequently exceeds the guidance given by regulatory bodies. In this article, we demonstrate that the use of surrogates in oncology is widespread and increasing. At the same time, the strength of association between the surrogates used and clinically meaningful outcomes is often unknown or weak. Attempts to validate surrogates are rarely undertaken. When this is done, validation relies on only a fraction of available data, and often concludes that the surrogate is poor. Post-marketing studies, designed to ensure drugs have meaningful benefits, are often not performed. Alternatively, if a drug fails to improve quality of life or overall survival, market authorization is rarely revoked. We suggest this reliance on surrogates, and the imprecision surrounding their acceptable use, means that numerous drugs are now approved based on small yet statistically significant increases in surrogates of questionable reliability. In turn, this means the benefits of many approved drugs are uncertain. This is an unacceptable situation for patients and professionals, as prior experience has shown that such uncertainty can be associated with significant harm. The use of surrogate outcomes should be limited to situations where a surrogate has demonstrated robust ability to predict meaningful benefits, or where cases are dire, rare or with few treatment options. In both cases, surrogates must be used only when continuing studies examining hard endpoints have been fully recruited.

Preclinical, Clinical, and Over-the-Counter Postmarketing Experience with a New Vaginal Cup: Menstrual Collection

PubMed Central

North, Barbara B.

2011-01-01

Abstract Background Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Methods Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. Results No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. Conclusions These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services. PMID:21194348

Preclinical, clinical, and over-the-counter postmarketing experience with a new vaginal cup: menstrual collection.

PubMed

North, Barbara B; Oldham, Michael J

2011-02-01

Menstrual cups have been available for decades, but their use is limited by bulky design and the need for multiple sizes. The Softcup® (Instead, Inc., San Diego, CA) is a simple single-size disposable over-the-counter (OTC) menstrual cup that compresses to tampon shape to facilitate insertion and can be worn during coitus. This report describes preclinical evaluation, clinical testing, and postmarketing monitoring of the Softcup. Preclinical testing complied with U.S. Food and Drug Administration (FDA) guidelines and used standard United States Pharmacopoeia methodologies for assessment of potential toxicity. Clinical testing enrolled 406 women in seven U.S. centers. A detailed written questionnaire assessed safety, acceptability, and effectiveness for menstrual collection. Study safety parameters included pelvic examinations, Pap smears, colposcopy, urinalysis, vaginal pH, wet mounts, gram stain, and vaginal microflora cultures. Postmarketing surveillance of over 100 million Softcups has been conducted by the manufacturer and by the FDA Medwatch system. No toxicity or mutagenicity was observed in preclinical evaluations. In clinical testing, after three cycles of cup use, 37% of subjects rated the cup as better than, 29% as worse than, and 34% as equal to pads or tampons. The cup was preferred for comfort, dryness, and less odor. Cups received lower ratings for disposal and convenience. Eighty-one percent of enrolled women were able to insert and remove their first cup using only written instructions. Use difficulties resulting in study discontinuations included cramping (1%), leakage (1%), and improper fit (3%). No safety parameters were adversely affected. No significant health risks were reported during postmarketing surveillance. These results demonstrate that a single-size vaginal device has no significant health risks and is acceptable to many women without the need for fitting or other medical services.

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

Expanded pharmacy technician roles: Accepting verbal prescriptions and communicating prescription transfers.

PubMed

Frost, Timothy P; Adams, Alex J

2017-11-01

As the role of the clinical pharmacist continues to develop and advance, it is critical to ensure pharmacists can operate in a practice environment and workflow that supports the full deployment of their clinical skills. When pharmacy technician roles are optimized, patient safety can be enhanced and pharmacists may dedicate more time to advanced clinical services. Currently, 17 states allow technicians to accept verbal prescriptions called in by a prescriber or prescriber's agent, or transfer a prescription order from one pharmacy to another. States that allow these activities generally put few legal limitations on them, and instead defer to the professional judgment of the supervising pharmacist whether to delegate these tasks or not. These activities were more likely to be seen in states that require technicians to be registered and certified, and in states that have accountability mechanisms (e.g., discipline authority) in place for technicians. There is little evidence to suggest these tasks cannot be performed safely and accurately by appropriately trained technicians, and the track record of success with these tasks spans four decades in some states. Pharmacists can adopt strong practice policies and procedures to mitigate the risk of harm from verbal orders, such as instituting read-back/spell-back techniques, or requiring the indication for each phoned-in medication, among other strategies. Pharmacists may also exercise discretion in deciding to whom to delegate these tasks. As the legal environment becomes more permissive, we foresee investment in more robust education and training of technicians to cover these activities. Thus, with the adoption of robust practice policies and procedures, delegation of verbal orders and prescription transfers can be safe and effective, remove undue stress on pharmacists, and potentially free up pharmacist time for higher-order clinical care. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of a co-delivered training package for community mental health professionals on service user- and carer-involved care planning.

PubMed

Grundy, A C; Walker, L; Meade, O; Fraser, C; Cree, L; Bee, P; Lovell, K; Callaghan, P

2017-08-01

WHAT IS KNOWN ON THE SUBJECT?: There is consistent evidence that service users and carers feel marginalized in the process of mental health care planning. Mental health professionals have identified ongoing training needs in relation to involving service users and carers in care planning. There is limited research on the acceptability of training packages for mental health professionals which involve service users and carers as co-facilitators. WHAT DOES THIS PAPER ADD TO EXISTING KNOWLEDGE?: A co-produced and co-delivered training package on service user- and carer-involved care planning was acceptable to mental health professionals. Aspects of the training that were particularly valued were the co-production model, small group discussion and the opportunity for reflective practice. The organizational context of care planning may need more consideration in future training models. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Mental health nurses using co-production models of delivering training to other mental health professionals can be confident that such initiatives will be warmly welcomed, acceptable and engaging. On the basis of the results reported here, we encourage mental health nurses to use co-production approaches more often. Further research will show how clinically effective this training is in improving outcomes for service users and carers. Background There is limited evidence for the acceptability of training for mental health professionals on service user- and carer-involved care planning. Aim To investigate the acceptability of a co-delivered, two-day training intervention on service user- and carer-involved care planning. Methods Community mental health professionals were invited to complete the Training Acceptability Rating Scale post-training. Responses to the quantitative items were summarized using descriptive statistics (Miles, ), and qualitative responses were coded using content analysis (Weber, ). Results Of 350 trainees, 310 completed the questionnaire. The trainees rated the training favourably (median overall TARS scores = 56/63; median 'acceptability' score = 34/36; median 'perceived impact' score = 22/27). There were six qualitative themes: the value of the co-production model; time to reflect on practice; delivery preferences; comprehensiveness of content; need to consider organizational context; and emotional response. Discussion The training was found to be acceptable and comprehensive with participants valuing the co-production model. Individual differences were apparent in terms of delivery preferences and emotional reactions. There may be a need to further address the organizational context of care planning in future training. Implications for practice Mental health nurses should use co-production models of continuing professional development training that involve service users and carers as co-facilitators. © 2017 The Authors. Journal of Psychiatric and Mental Health Nursing Published by John Wiley & Sons Ltd.

Ready for eHealth? Health Professionals' Acceptance and Adoption of eHealth Interventions in Inpatient Routine Care.

PubMed

Hennemann, Severin; Beutel, Manfred E; Zwerenz, Rüdiger

2017-03-01

eHealth interventions can be effective in treating health problems. However, adoption in inpatient routine care seems limited. The present study therefore aimed to investigate barriers and facilitators to acceptance of eHealth interventions and of online aftercare in particular in health professionals of inpatient treatment. A total of 152 out of 287 health professionals of various professional groups in four inpatient rehabilitation facilities filled out a self-administered web-based questionnaire (response rate: 53%); 128 individuals were eligible for further data analysis. Acceptance and possible predictors were investigated with a complex research model based on the Unified Theory of Acceptance and Use of Technology. Acceptance of eHealth interventions was rather low (M = 2.47, SD = 0.98); however, acceptance of online aftercare was moderate (M = 3.08, SD = 0.96, t(127) = 8.22, p < .001), and eHealth literacy was elevated. Social influence, performance expectancy, and treatment-related internet and mobile use significantly predicted overall acceptance. No differences were found between professional and age groups. Although acceptance of eHealth interventions was limited in health professionals of inpatient treatment, moderate acceptance of online aftercare for work-related stress implies a basis for future implementation. Tailored eHealth education addressing misconceptions about inferiority and incongruity with conventional treatment considering the systemic aspect of acceptance formation are needed.

Development of rapid phenotypic system for the identification of Gram-negative oxidase-positive bacilli in resource-limited settings.

PubMed

Kazmi, Mahmooda; Khan, Adnan; Kazmi, Shahana Urooj

2013-06-01

Rapid and accurate identification of bacterial pathogens is a fundamental goal of clinical microbiology. The diagnosis and surveillance of diseases is dependent, to a great extent, on laboratory services, which cannot function without effective reliable reagents and diagnostics. Despite the advancement in microbiology diagnosis globally, resourcelimited countries still struggle to provide an acceptable diagnosis quality which helps in clinical disease management and improve their mortality and morbidity data. During this study an indigenous product, Quick Test Strip (QTS) NE, was developed for the rapid identification of biochemically slower group of Gram-negative oxidase-positive bacilli that covers 19 different bacterial genera. Some of the members belonging to these groups are well-established human pathogens, e.g. various species of Vibrio, Pseudomonas, Burkholderia, Aeromonas, Achromobacter and Stenotrophomonas. This study also evaluates the performance of QTS-NE by comparing with genotypic characterization methods. A total of 232 clinical and reference bacterial isolates were tested by three different methods. QTSNE provides 100 percent concordant results with other rapid identification and molecular characterization methods and confirms the potential to be used in clinical diagnosis.

Comparison of clinical and physics scoring of PET images when image reconstruction parameters are varied.

PubMed

Walsh, C; Johnston, C; Sheehy, N; O' Reilly, G

2013-02-01

In this study the quantitative and qualitative image quality (IQ) measurements with clinical judgement of IQ in positron emission tomography (PET) were compared. The limitations of IQ metrics and the proposed criteria of acceptability for PET scanners are discussed. Phantom and patient images were reconstructed using seven different iterative reconstruction protocols. For each reconstructed set of images, IQ was scored based both on the visual analysis and on the quantitative metrics. The quantitative physics metrics did not rank the reconstruction protocols in the same order as the clinicians' scoring of perceived IQ (R(s)=-0.54). Better agreement was achieved when comparing the clinical perception of IQ to the physicist's visual assessment of IQ in the phantom images (R(s)=+0.59). The closest agreement was seen between the quantitative physics metrics and the measurement of the standard uptake values (SUVs) in small tumours (R(s)=+0.92). Given the disparity between the clinical perception of IQ and the physics metrics a cautious approach to use of IQ measurements for determining suspension levels is warranted.

Fourier-domain angle-resolved low coherence interferometry for clinical detection of dysplasia

NASA Astrophysics Data System (ADS)

Terry, Neil G.; Zhu, Yizheng; Wax, Adam

2010-02-01

Improved methods for detecting dysplasia, or pre-cancerous growth are a current clinical need, particularly in the esophagus. The currently accepted method of random biopsy and histological analysis provides only a limited examination of tissue in question while being coupled with a long time delay for diagnosis. Light scattering spectroscopy, in contrast, allows for inspection of the cellular structure and organization of tissue in vivo. Fourier-domain angle-resolved low-coherence interferometry (a/LCI) is a novel light scattering spectroscopy technique that provides quantitative depth-resolved morphological measurements of the size and optical density of the examined cell nuclei, which are characteristic biomarkers of dysplasia. Previously, clinical viability of the a/LCI system was demonstrated through analysis of ex vivo human esophageal tissue in Barrett's esophagus patients using a portable a/LCI, as was the development of a clinical a/LCI system. Data indicating the feasibility of the technique in other organ sites (colon, oral cavity) will be presented. We present an adaptation of the a/LCI system that will be used to investigate the presence of dysplasia in vivo in Barrett's esophagus patients.

MO-G-BRE-02: A Survey of IMRT QA Practices for More Than 800 Institutions

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

Pulliam, K; Kerns, J; Howell, R

Purpose: A wide range of techniques and measurement devices are employed for IMRT QA, causing a large variation of accepted action limits and potential follow up for failing plans. Such procedures are not well established or accepted in the medical physics community. To achieve the goal of proving insight into current IMRT QA practices, we created an electronic IMRT QA survey. The survey was open to a variety of the most common QA devices and assessed the type of comparison to measurement, action limits, delivery methods, and clinical action for failing QA plans. Methods: We conducted an online survey throughmore » the Radiological Physics Center's (RPC) annual survey with the goal of ascertaining elements of routine patient-specific IMRT QA. A total of 874 institutions responded to the survey. The questions ranged from asking for action limits, dosimeter type(s) used, delivery techniques, and actions taken when a plan fails IMRT QA. Results: The most common (52%) planar gamma criteria was 3%/3 mm with a 95% of pixels passing criteria. The most common QA device were diode arrays (48%). The most common first response to a plan failing QA was to re-measure at the same point the point dose (89%), second was to re-measure at a new point (13%), and third was to analyze the plan in relative instead of absolute mode (10%) (Does not add to 100% as not all institutions placed a response for each QA follow-up option). Some institutions, however, claimed that they had never observed a plan failure. Conclusion: The survey provided insights into the way the community currently performs IMRT QA. This information will help in the push to standardize action limits among dosimeters.« less

The clinical effectiveness, cost-effectiveness and acceptability of community-based interventions aimed at improving or maintaining quality of life in children of parents with serious mental illness: a systematic review.

PubMed

Bee, Penny; Bower, Peter; Byford, Sarah; Churchill, Rachel; Calam, Rachel; Stallard, Paul; Pryjmachuk, Steven; Berzins, Kathryn; Cary, Maria; Wan, Ming; Abel, Kathryn

2014-02-01

Serious parental mental illness poses a challenge to quality of life (QoL) in a substantial number of children and adolescents. Improving the lives of these children is a political and public health concern. To conduct an evidence synthesis of the clinical effectiveness, cost-effectiveness and acceptability of community-based interventions for improving QoL in children of parents with serious mental illness (SMI). Nineteen health, allied health and educational databases, searched from database inception to May 2012, and supplemented with hand searches, reference checking, searches of grey literature, dissertations, ongoing research registers, forward citation tracking and key author contact. Inclusion criteria required≥50% of parents to have SMI or severe depression confirmed by clinical diagnosis or baseline symptoms. Children were ≤18 years of age. Community-based interventions included any non-residential psychological/psychosocial intervention involving parents or children for the purposes of improving health or well-being. Intervention comparators were not predefined and primary outcomes were validated measures of children's QoL and emotional health. Secondary outcomes were derived from UK policy and stakeholder consultation. Data were extracted independently by two reviewers and the study quality was assessed via Cochrane criteria for randomised/non-randomised designs, Critical Appraisal Skills Programme (CASP) qualitative criteria or a standard checklist for economic evaluations. Separate syntheses were conducted for SMI and severe depression. Standardised effect size (ES) trials were pooled using random-effects modelling for which sufficient data were available. Economic data were summarised and acceptability data were synthesised via a textual narrative approach. Three trials targeted mothers/the children of mothers with psychotic symptoms. Children were ≤12 years of age and no primary QoL or emotional health outcomes were reported. Insufficient secondary outcome data prevented pooling and no eligible economic evaluations were found. Twenty-six trials targeted parents/children of parents with severe depression; 18 recruited mothers of infants<2.5 years of age. Data pooling suggested no significant short-term effect on children's emotional health [standardised ES 0.06, 95% confidence interval (CI) -0.20 to 0.33] or social function (standardised ES 0.23, 95% CI 0.00 to 0.46). Medium to large effects were observed for parents' depressive symptoms (standardised ES 0.73, 95% CI 0.51 to 0.94) and parenting behaviours (standardised ES 0.67, 95% CI 0.32 to 1.02). One non-randomised economic evaluation was found. Intervention uptake and adherence were inconsistently reported. Incomplete evidence highlighted potential barriers from child custody losses and conflicting life circumstances. Qualitative data suggesting interventions to overcome social isolation and stigma are well received by parents. Limited data suggested that children may value peer interactions and normalising activities. Included trials were of poor or unclear quality with inadequate randomisation or allocation concealment, possible attrition biases and incomplete outcome reporting. Meaningful analysis was challenged by clinical and methodological heterogeneity and insufficient data for subgroup comparisons. Children's self-reports were lacking and evidence of effect remains biased towards parent-based interventions for severely depressed mothers of infants. Generalisability to other diagnoses, older children and children of fathers with SMI is unclear. A lack of high-quality economic data prevented economic modelling. Evidence for community-based interventions to enhance QoL in children of SMI parents is lacking. The capacity to recommend evidence-based approaches is limited. Rigorous development work is needed to establish feasible and acceptable child- and family-based interventions, prior to evaluating clinical effectiveness and cost-effectiveness via a randomised controlled trial (RCT). A substantial programme of pilot work is recommended to underpin the development of feasible and acceptable interventions for this population. Evaluations should incorporate validated, child-centred QoL outcome measures, high-quality cost data and nested, in-depth acceptability studies. New age-appropriate instruments that better reflect the life priorities and unique challenges faced by children of parents with SMI may need to be developed. This report was commissioned by the NHS R&D Health Technology Assessment programme and funded by the National Institute for Health Research Health Technology Assessment programme.

Farmers' markets' uptake of food assistance programmes in East Tennessee, USA.

PubMed

Russomanno, Jennifer; Jabson, Jennifer M

2016-10-01

Limited acceptance of government food assistance programmes such as the US Department of Agriculture's (USDA) Supplemental Nutrition Assistance Program (SNAP) is a barrier that produces unequal access to market products for SNAP beneficiaries. There is a dearth of published evidence to explain the limited SNAP acceptance at farmers' markets. The current project aimed to fill this gap; to identify and describe the barriers to markets' acceptance of SNAP. Cross-sectional, semi-structured interviews were conducted. All interviews were conducted via telephone. Twelve East Tennessee area market managers, vendors and other key stakeholders. Multiple barriers exist for SNAP implementation at markets including administrative and time limitations, prejudice from market vendors against SNAP beneficiaries, and resistance to invasive and burdensome requirements of the USDA SNAP application required for farmers' markets. SNAP acceptance at farmers' markets is a complex issue, especially for small, rural markets. If farmers' markets are to serve as sustainable resources to increase food access, these issues must be addressed so that SNAP can be accepted. Successful implementation of SNAP at rural markets requires increased administrative support and vendor education about SNAP and its beneficiaries. A revised USDA SNAP application process for farmers' markets should also be considered.

Meanings and implications of acceptability judgements for wilderness use impacts

Treesearch

Amy F. Hoss; Mark W. Brunson

2000-01-01

While the concept of “acceptability” is central to the Limits of Acceptable Change (LAC) framework, there is inadequate understanding of how “acceptability” is judged and how unacceptable conditions affect visitor experiences. To address this knowledge gap, visitors to nine wilderness areas were interviewed. Judgments of social and environmental conditions fell into...

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…

Historical development of limits of acceptable change: conceptual clarifications and possible extensions

Treesearch

David N. Cole; George H. Stankey

1997-01-01

The Limits of Acceptable Change (LAC) process was developed to deal with the issue of recreational carrying capacity. For that purpose, the LAC process sought to explicitly define a compromise between resource/visitor experience protection and recreation use goals. The most critical and unique element of the process is the specification of LAC standards that define...

Experiencing limits of acceptable change: some thoughts after a decade of implementation

Treesearch

Stephen F. McCool; David N. Cole

1997-01-01

Wilderness managers and researchers have experienced implementation of the Limits of Acceptable Change planning system for over a decade. In a sense, implementation of LAC has been a broad scale experiment in planning, with the hypothesis being that LAC processes are more effective approaches to deal with questions of recreation management in protected areas than the...

Institutional barriers and opportunities in application of the limits of acceptable change

Treesearch

George H. Stankey

1997-01-01

Although the Limits of Acceptable Change (LAC) process has been in use since the mid-1980’s and has contributed to improved wilderness management, significant barriers and challenges remain. Formal and informal institutional barriers are the principal constraint to more effective implementation. Although grounded in a traditional management-by-objectives model, the LAC...

Defining fire and wilderness objectives: Applying limits of acceptable change

Treesearch

David N. Cole

1995-01-01

The Limits of Acceptable Change (LAC) planning process was developed to help define objectives for recreation management in wilderness. This process can be applied to fire in wilderness if its conceptual foundation is broadened. LAC would lead decision makers to identify a compromise between the goal of allowing fire to play its natural role in wilderness and various...

The limits of acceptable change process: modifications and clarifications

Treesearch

David N. Cole; Stephen F. McCool

1997-01-01

Limits of Acceptable Change (LAC) was originally formulated to deal with the issue of recreation carrying capacity in wilderness. Enthusiasm for the process has led to questions about its applicability to a broad range of natural resource issues—both within and outside of protected areas. This paper uses a generic version of the LAC process to identify situations where...

7 CFR 42.133 - Portion of production acceptance criteria.

Code of Federal Regulations, 2011 CFR

2011-01-01

... CONTAINER REGULATIONS STANDARDS FOR CONDITION OF FOOD CONTAINERS On-Line Sampling and Inspection Procedures... determined by comparing the calculated CuSum value with the acceptance limit (“L”) for the specified AQL. (b) A portion of production is acceptable if the CuSum value, calculated from the subgroup representing...

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.

Second-stage labor: how long is too long?

PubMed

Leveno, Kenneth J; Nelson, David B; McIntire, Donald D

2016-04-01

The management of labor has come under increased scrutiny due to the rapid escalation of cesarean delivery in the United States. A workshop of the Society for Maternal-Fetal Medicine, the Eunice Kennedy Shriver National Institute of Child Health and Human Development, and the American Congress of Obstetricians and Gynecologists was convened to address the rising cesarean delivery rates and one of their recommendations was that the accepted upper limit of the second stage of labor should be increased to ≥4 hours in nulliparous women with epidural analgesia and to ≥3 hours in parous women with epidural. This led to the inaugural Obstetric Care Consensus series document, "Safe Prevention of the Primary Cesarean Delivery," wherein the workshop recommendations on second-stage labor were promulgated nationally. The result is that the now acceptable maximum length of the second stage of labor exceeds the obstetric precepts that have been in use for >50 years. In this Clinical Opinion, we review the evidence on infant safety, vis-à-vis length of the second stage of labor. Our examination of the evidence begins at the outset of the 20th century and culminates in the very recent (2014) recommendation to abandon the long accepted obstetric paradigm that second-stage labor >3 hours in nulliparous women with labor epidural is unsafe for the unborn infant. We conclude that the currently available evidence fails to support the Obstetric Care Consensus position that longer second-stage labor is safe for the unborn infant. Indeed, the evidence suggests quite the opposite. We suggest that when infant safety is at stake the evidence should be robust before a new clinical road is taken. The evidence is not robust. Copyright © 2016 Elsevier Inc. All rights reserved.

Social networking technologies as emerging tools for HIV prevention: A Cluster Randomized Trial

PubMed Central

Young, Sean D.; Cumberland, William G.; Lee, Sung-Jae; Jaganath, Devan; Szekeres, Greg; Coates, Thomas

2013-01-01

Background Social networking technologies are an emerging tool for HIV prevention. Objective To determine whether social networking communities can increase HIV testing among African American and Latino men who have sex with men (MSM). Design Randomized; controlled trial with concealed allocation (ClinicalTrials.gov: NCT01701206). Setting Online. Patients 112 MSM based in Los Angeles, more than 85% of whom were African American or Latino. Intervention Sixteen peer leaders were randomly assigned to deliver information about HIV or general health to participants via Facebook groups over 12 weeks. After participants accepted a request to join the group, participation was voluntary. Group participation and engagement was monitored. Participants could request a free home-based HIV testing kit and completed questionnaires at baseline and 12-week follow-up. Measurements Participant acceptance of and engagement in the intervention and social network participation, rates of home-based HIV testing, and sexual risk behaviors. Results Almost 95% of intervention participants and 73% of control participants voluntarily communicated using the social platform. Twenty-five of the 57 intervention participants (44%) requested home-based HIV testing kits compared with 11 of 55 control participants (20%) (difference, 24 percentage points [95% CI, 8 to 41 percentage points]). Nine of the 25 intervention participants (36%) who requested the test took it and mailed it back compared with 2 of the 11 control participants (18%) who requested the test. Retention at study follow-up was more 93%. Limitations Only 2 Facebook communities were included for each group. Conclusions Social networking communities are acceptable and effective tools to increase home-based HIV testing among at-risk populations. Primary funding source National Institute of Mental Health ClinicalTrials.gov Identifier (NCT01701206) PMID:24026317

Research ethics committee decision-making in relation to an efficient neonatal trial.

PubMed

Gale, C; Hyde, M J; Modi, N

2017-07-01

Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. 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/.

Medication safety research by observational study design.

PubMed

Lao, Kim S J; Chui, Celine S L; Man, Kenneth K C; Lau, Wallis C Y; Chan, Esther W; Wong, Ian C K

2016-06-01

Observational studies have been recognised to be essential for investigating the safety profile of medications. Numerous observational studies have been conducted on the platform of large population databases, which provide adequate sample size and follow-up length to detect infrequent and/or delayed clinical outcomes. Cohort and case-control are well-accepted traditional methodologies for hypothesis testing, while within-individual study designs are developing and evolving, addressing previous known methodological limitations to reduce confounding and bias. Respective examples of observational studies of different study designs using medical databases are shown. Methodology characteristics, study assumptions, strengths and weaknesses of each method are discussed in this review.

A computer-aided movement analysis system.

PubMed

Fioretti, S; Leo, T; Pisani, E; Corradini, M L

1990-08-01

Interaction with biomechanical data concerning human movement analysis implies the adoption of various experimental equipments and the choice of suitable models, data processing, and graphical data restitution techniques. The integration of measurement setups with the associated experimental protocols and the relative software procedures constitutes a computer-aided movement analysis (CAMA) system. In the present paper such integration is mapped onto the causes that limit the clinical acceptance of movement analysis methods. The structure of the system is presented. A specific CAMA system devoted to posture analysis is described in order to show the attainable features. Scientific results obtained with the support of the described system are also reported.

The Effect of Total Cost Information on Consumer Treatment Decisions: An Experimental Survey.

PubMed

Kwon, Regina; Allen, Larry A; Scherer, Laura D; Thompson, Jocelyn S; Abdel-Maksoud, Madiha F; McIlvennan, Colleen K; Matlock, Daniel D

2018-07-01

Unrestrained use of expensive, high-risk interventions runs counter to the idea of a limited medical commons. To examine the effect of displaying the total first-year cost of implanting a left ventricular assist device (LVAD) on a hypothetical treatment decision and whether this effect differs when choosing for oneself versus for another person. We conducted an online survey in February 2016. The survey described the clinical course of end-stage heart failure and the risks and benefits of an LVAD. Participants were randomized to 1 of 4 scenarios, which varied by patient identity (oneself versus another person) and description of total cost. This study measured acceptance of LVAD implantation. Reasoning and attitudes were secondarily explored. We received 1211 valid responses. The mean age was 38.3 y (±12.8); 53.5% were female and 84.4% were white. Participants were more likely to accept an LVAD when shown the total cost (66.2% v. 58.0%, P = 0.003) or when choosing for another (68.0 % v. 56.4%, P < 0.001). Open-ended responses indicated that acceptors wanted to extend survival while decliners feared poor quality of life with LVAD therapy. Acceptors and decliners agreed that consumers can help lower the cost of health care, but decliners were more likely to consider cost when making health care decisions ( P < 0.001). Limitations include the use of a hypothetical scenario, the use of paid participants, and differences between the respondents and the typical patient facing an LVAD decision. In this sample, being shown the total cost increased the likelihood of accepting an expensive, high-risk treatment. The results question how well consumers understand the relationship between expensive treatments and the commons.

Use of Low-Literacy Decision Aid to Enhance Knowledge and Reduce Decisional Conflict Among a Diverse Population of Adults With Rheumatoid Arthritis: Results of a Pilot Study.

PubMed

Barton, Jennifer L; Trupin, Laura; Schillinger, Dean; Evans-Young, Gina; Imboden, John; Montori, Victor M; Yelin, Edward

2016-07-01

Despite innovations in treatment of rheumatoid arthritis (RA), adherence is poor and disparities persist. Shared decision making (SDM) promotes patient engagement and enhances adherence; however, few tools support SDM in RA. Our objective was to pilot a low-literacy medication guide and decision aid to facilitate patient-clinician conversations about RA medications. RA patients were consecutively enrolled into 1 of 3 arms: 1) control; patients received existing medication guide prior to clinic visit, 2) adapted guide prior to visit, and 3) adapted guide prior to plus decision aid during visit. Outcomes were collected immediately postvisit, at 1-week, and at 3- and 6-month interviews. Eligible adults had to have failed at least 1 disease-modifying antirheumatic drug and fulfill 1 of the following: age >65 years, immigrant, non-English speaker, less than high school education, limited health literacy, and racial/ethnic minority. Primary outcomes were knowledge of RA medications, decisional conflict, and acceptability of interventions. The majority of 166 patients were immigrants (66%), non-English speakers (54%), and had limited health literacy (71%). Adequate RA knowledge postvisit in arm 3 was higher (78%) than arm 1 (53%; adjusted odds ratio 2.7, 95% confidence interval 1.2, 6.1). Among patients with a medication change, there was lower (better) mean decisional conflict in arms 2 and 3 (P = 0.03). There were no significant differences in acceptability. A low-literacy medication guide and decision aid was acceptable, improved knowledge, and reduced decisional conflict among vulnerable RA patients. Enhancing knowledge and patient engagement with decision support tools may lead to medication choices better aligned with RA patients' values and preferences. © 2016, American College of Rheumatology.

Accuracy and trending ability of the fourth-generation FloTrac/Vigileo System™ in patients undergoing abdominal aortic aneurysm surgery.

PubMed

Maeda, Takuma; Hattori, Kohshi; Sumiyoshi, Miho; Kanazawa, Hiroko; Ohnishi, Yoshihiko

2018-06-01

The fourth-generation FloTrac/Vigileo™ improved its algorithm to follow changes in systemic vascular resistance index (SVRI). This revision may improve the accuracy and trending ability of CI even in patients who undergo abdominal aortic aneurysm (AAA) surgery which cause drastic change of SVRI by aortic clamping. The purpose of this study is to elucidate the accuracy and trending ability of the fourth-generation FloTrac/Vigileo™ in patients with AAA surgery by comparing the FloTrac/Vigileo™-derived CI (CI FT ) with that measured by three-dimensional echocardiography (CI 3D ). Twenty-six patients undergoing elective AAA surgery were included in this study. CI FT and CI3 D were determined simultaneously in eight points including before and after aortic clamp. We used CI 3D as the reference method. In the Bland-Altman analysis, CI FT had a wide limit of agreement with CI 3D showing a percentage error of 46.7%. Subgroup analysis showed that the percentage error between CO 3D and CO FT was 56.3% in patients with cardiac index < 2.5 L/min/m 2 and 28.4% in patients with cardiac index ≥ 2.5 L/min/m 2 . SVRI was significantly higher in patients with cardiac index < 2.5 L/min/m 2 (1703 ± 330 vs. 2757 ± 798; p < 0.001). The tracking ability of fourth generation of FloTrac/Vigileo™ after aortic clamp was not clinically acceptable (26.9%). The degree of accuracy of the fourth-generation FloTrac/Vigileo™ in patients with AAA surgery was not acceptable. The tracking ability of the fourth-generation FloTrac/Vigileo™ after aortic clamp was below the acceptable limit.

Legitimization of regulatory norms: Waterfowl hunter acceptance of changing duck bag limits

USGS Publications Warehouse

Schroeder, Susan A.; Fulton, David C.; Lawrence, Jeffrey S.; Cordts, Steven D.

2014-01-01

Few studies have examined response to regulatory change over time, or addressed hunter attitudes about changes in hunting bag limits. This article explores Minnesota waterfowl hunters’ attitudes about duck bag limits, examining attitudes about two state duck bag limits that were initially more restrictive than the maximum set by the U.S. Fish and Wildlife Service (USFWS), but then increased to match federal limits. Results are from four mail surveys that examined attitudes about bag limits over time. Following two bag limit increases, a greater proportion of hunters rated the new bag limit “too high” and a smaller proportion rated it “too low.” Several years following the first bag limit increase, the proportion of hunters who indicated that the limit was “too high” had declined, suggesting hunter acceptance of the new regulation. Results suggest that waterfowl bag limits may represent legal norms that influence hunter attitudes and gain legitimacy over time.

Role of thought-related beliefs and coping strategies in the escalation of intrusive thoughts: an analog to obsessive-compulsive disorder.

PubMed

Marcks, Brook A; Woods, Douglas W

2007-11-01

Cognitive-behavioral models of obsessive-compulsive disorder (OCD) assume that obsessions have their origin in normal intrusive thoughts. These models propose that certain beliefs, such as thought-action fusion (TAF) beliefs, combined with the use of ineffective coping strategies, such as thought suppression, lead to the development of OCD. The purpose of the current study was to examine the relationship between these variables in a non-clinical sample in addition to exploring the effects of an alternative, acceptance-based coping strategy. This study explored the relationship between TAF beliefs, thought suppression, and OC-consistent symptoms via mediational analyses. Results showed that thought suppression mediated the relationship between TAF beliefs and OC-consistent symptoms. This study also experimentally examined the effects of various coping strategies (suppression, acceptance, or monitor-only) on the frequency of a distressing intrusion and appraisal ratings (e.g., anxiety, guilt, responsibility) after a TAF induction. Spontaneous suppression in the monitor-only group made comparisons of the experimental data difficult. However, analyses provided preliminary evidence suggesting that thought suppression is related to more intrusions, higher levels of anxiety, and negative appraisals, whereas an acceptance-based approach may be a useful alternative. Additional findings, limitations of the current study, and directions for future research are discussed.

Human cervix: an alternative substrate for detecting circulating pemphigus antibodies.

PubMed

Chularojanamontri, Leena; Tuchinda, Papapit; Pinkaew, Sumruay; Chanyachailert, Pattriya; Petyim, Somsin; Sangkarat, Suthi; Kulthanan, Kanokvalai; Suthipinittharm, Puan

2016-08-01

Monkey esophagus (ME) is a well-accepted substrate for diagnosing pemphigus vulgaris (PV) by indirect immunofluorescence (IIF). However, its availability is sometimes limited due to ethical concerns. This study aimed to investigate the usefulness of human cervix (HC) as a substrate in the diagnosis of PV by IIF. Initially, serum from 1 PV patient was incubated with tissues from 48 HCs. Median IIF titers on HCs that had different demographic and clinical characteristics were compared. Sera from 5 PV patients were then incubated with ME and 21 HCs. For each serum, the titer of IIF on HC that was not different from ME by more than two-fold dilutions was acceptable. Last, sera from 42 PV, 14 pemphigus foliaceous, and 62 non-pemphigus patients were used to evaluate sensitivity and specificity. The results demonstrate that differences in demographic data among HCs did not affect IIF titers. Titers obtained from ME and HC were comparable (81-100 % acceptable values). Sensitivity of HC for diagnosis of PV was better than for diagnosis of pemphigus foliaceus (90.5 and 71.4 %, respectively). Specificity for PV and PF was 96.2 %. We proposed that HC substrate can be used as an alternative substrate for diagnosis of PV by IIF.

Content validity across methods of malnutrition assessment in patients with cancer is limited.

PubMed

Sealy, Martine J; Nijholt, Willemke; Stuiver, Martijn M; van der Berg, Marit M; Roodenburg, Jan L N; van der Schans, Cees P; Ottery, Faith D; Jager-Wittenaar, Harriët

2016-08-01

To identify malnutrition assessment methods in cancer patients and assess their content validity based on internationally accepted definitions for malnutrition. Systematic review of studies in cancer patients that operationalized malnutrition as a variable, published since 1998. Eleven key concepts, within the three domains reflected by the malnutrition definitions acknowledged by European Society for Clinical Nutrition and Metabolism (ESPEN) and the American Society for Parenteral and Enteral Nutrition (ASPEN): A: nutrient balance; B: changes in body shape, body area and body composition; and C: function, were used to classify content validity of methods to assess malnutrition. Content validity indices (M-CVIA-C) were calculated per assessment method. Acceptable content validity was defined as M-CVIA-C ≥ 0.80. Thirty-seven assessment methods were identified in the 160 included articles. Mini Nutritional Assessment (M-CVIA-C = 0.72), Scored Patient-Generated Subjective Global Assessment (M-CVIA-C = 0.61), and Subjective Global Assessment (M-CVIA-C = 0.53) scored highest M-CVIA-C. A large number of malnutrition assessment methods are used in cancer research. Content validity of these methods varies widely. None of these assessment methods has acceptable content validity, when compared against a construct based on ESPEN and ASPEN definitions of malnutrition. Copyright © 2016 Elsevier Inc. All rights reserved.

Chile: Acceptability of a Training Program for Depression Management in Primary Care

PubMed Central

Marín, Rigoberto; Martínez, Pablo; Cornejo, Juan P.; Díaz, Berta; Peralta, José; Tala, Álvaro; Rojas, Graciela

2016-01-01

Background: In Chile, there are inconsistencies in the management of depression in primary care settings, and the National Depression Program, currently in effect, was implemented without a standardized training program. The objective of this study is to evaluate the acceptability of a training program on the management of depression for primary care health teams. Methods: The study was a randomized controlled trial, and two primary centers from the Metropolitan Region of Santiago were randomly selected to carry out the intervention training program. Pre-post surveys were applied, to evaluate expectations and satisfaction with the intervention, respectively. Descriptive and content analysis was carried out. Result: The sample consisted of 41 health professionals, 56.1% of who reported that their expectations for the intervention were met. All of the training activities were evaluated with scores higher than 6.4 (on a 1–7 scale). The trainers, the methodology, and the learning environment were considered strengths and facilitators of the program, while the limited duration of the training, the logistical problems faced during part of the program, and the lack of educational material were viewed as weaknesses. Conclusion: The intervention was well accepted by primary health care teams. However, the clinical impact in patients still has to be evaluated. PMID:27375531

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

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.

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.

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

Placebo Use in Pain Management: A Mechanism-Based Educational Intervention Enhances Placebo Treatment Acceptability.

PubMed

Kisaalita, Nkaku R; Hurley, Robert W; Staud, Roland; Robinson, Michael E

2016-02-01

Health care providers use treatments whose effectiveness derives partially or completely from 'nonspecific' factors, frequently referred to as placebo effects. Although the ethics of interventional placebo use continues to be debated, evidence suggests that placebos can produce clinically meaningful analgesic effects. Burgeoning evidence suggest that patients with chronic pain might be open to placebo treatments in certain contexts despite limited knowledge of their well-established psychoneurobiological underpinnings. In this investigation we sought to examine the effects of a brief, mechanism-based placebo analgesia educational intervention on aspects placebo knowledge and acceptability. Participants with chronic musculoskeletal pain completed a web-based survey in which they rated their knowledge of placebo analgesia, assessed placebo acceptability across different medical contexts, and evaluated 6 unique patient-provider treatment scenarios to assess the role of treatment effectiveness and deception on patient-provider attributions. Using a pre-post design, participants were randomized to receive either a placebo educational intervention or an active control education. Results showed that the educational intervention greatly improved perceptions of placebo knowledge, effectiveness, and acceptability, even in deceptive treatment contexts. This was the first study of its kind to show the value of an educational intervention in increasing openness to and knowledge of placebo analgesic interventions among patients with chronic musculoskeletal pain. In this we article highlight how patients with chronic pain might be open to placebo interventions, particularly adjunct and/or complementary treatments, when provided education on the neurobiological and psychological mechanisms that underlie placebo effects. Study findings highlight ethically acceptable ways to potentially use placebo factors to enhance existing pain treatments and improve patient health outcomes. Published by Elsevier Inc.

Are one-stop shops acceptable? Community perspectives on one-stop shop models of sexual health service provision in the UK.

PubMed

Griffiths, C; Gerressu, M; French, R S

2008-10-01

Traditionally, genitourinary medicine (GUM) and contraceptive services have been provided separately. Providing these services on one site, as a one-stop shop, has been suggested as a way of improving access to care. There is little evidence about the acceptability of such an approach. We aimed to assess acceptability of different one-stop shop models (a young people's, an all ages (mainstream) and a general practice service) of sexual health provision among different community groups. Between April and December 2005, 19 semi-structured interviews and 14 focus groups were conducted with young heterosexual men (n = 48), men who have sex with men (MSM; n = 46) and minority ethnic men and women (n = 28) across England. Knowledge of one-stop shops was limited. The concept was acceptable to participants (except MSM), although there was variation as to the preferred model. Young men and African individuals described distrust of general practice confidentiality, preferring young people's or mainstream models, respectively. South Asians associated stigma with GUM, preferring instead a general practice one-stop shop. Regardless of model, respondents expressed preference for one provider/one session to provide GUM and contraceptive care. In terms of acceptability there can be no blue print one-stop shop model. Local assessments should determine whether a one-stop shop would have public health benefit and if so how best one should be set up to maximise access. To accommodate client preference for one provider/session for their sexual health needs it may be that the development of "integrated training" for providers across clinical specialties is a more realistic way forward.

C-reactive protein point-of-care testing in acutely ill children: a mixed methods study in primary care.

PubMed

Van den Bruel, Ann; Jones, Caroline; Thompson, Matthew; Mant, David

2016-04-01

Point-of-care C-reactive protein (CRP) testing of adults with acute respiratory infection in primary care reduces antibiotic prescribing by 22%. The acceptability and impact of CRP testing in children is unknown To determine the acceptability and impact of CRP testing in acutely ill children. Mixed methods study comprising an observational cohort with a nested randomised controlled trial and embedded qualitative study. Children presenting with an acute illness to general practice out-of-hours services; children with a temperature ≥38°C were randomised in the nested trial; parents and clinical staff were invited to the qualitative study. Informed consent rates; parental and staff views on testing. Consent to involvement in the study was obtained for 200/297 children (67.3%, 95% CI 61.7% to 72.6%); the finger-prick test might have been a contributory factor for 63 of the 97 children declining participation but it was cited as a definite factor in only 10 cases. None of the parents or staff raised concerns about the acceptability of testing, describing the pain caused as minor and transient. General practitioner views on the utility of the CRP test were inconsistent. CRP point-of-care testing in children is feasible in primary care and is likely to be acceptable. However, it will not reduce antibiotic prescribing and hospital referrals until general practitioners accept its diagnostic value in children. ISRCTN 69736109. 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/

Development and validation of the Female Sexual Function Index adaptation for breast cancer patients (FSFI-BC).

PubMed

Bartula, Iris; Sherman, Kerry A

2015-08-01

Sexual dysfunction following breast cancer treatment is common and screening for this is recommended. This study determined the reliability, validity, and acceptability of a breast cancer-specific adaptation of the Female Sexual Function Index, the FSFI-BC. This new measure addresses limitations in the FSFI when assessing sexual dysfunction of women with breast cancer regarding applicability to non-sexually active women, measuring distress and changes after cancer. Female breast cancer survivors (n = 596; 429 sexually active, 166 non-sexually active) completed an online survey including demographic/medical information, the FSFI-BC, and scales measuring sexual functioning, fatigue, body image, physical and mental health, and relationship adjustment (Time 1). Three weeks later, 326 women (245 sexually active; 81 non-sexually active) completed the Time 2 survey including the FSFI-BC, and questions regarding its acceptability and perceived change in sexual functioning. Reliability, construct validity, and acceptability were examined using standard scale validation techniques. Exploratory factor analysis delineated seven factors: Changes after cancer, desire/arousal, lubrication, orgasm, pain, satisfaction, and distress, accounting for 79.98 % (sexually active) and 77.19 % (non-active) variance in responses. Acceptable internal consistencies (non-active: α = 0.71-0.96; sexually active: α = 0.89-0.96) and test-retest reliabilities (non-active: r = 0.63-0.86; sexually active: r = 0.71-0.88) were evident. Inter-scale correlations provided evidence for convergent and divergent validities of the FSFI-BC. Both sexually active and non-active women provided positive feedback about the FSFI-BC. The optional partner questions demonstrated clinical utility. With desirable psychometric properties and acceptability to participants, the FSFI-BC is suitable for screening for sexual dysfunction in women with breast cancer.

Relationship between haemagglutination-inhibiting antibody titres and clinical protection against influenza: development and application of a bayesian random-effects model.

PubMed

Coudeville, Laurent; Bailleux, Fabrice; Riche, Benjamin; Megas, Françoise; Andre, Philippe; Ecochard, René

2010-03-08

Antibodies directed against haemagglutinin, measured by the haemagglutination inhibition (HI) assay are essential to protective immunity against influenza infection. An HI titre of 1:40 is generally accepted to correspond to a 50% reduction in the risk of contracting influenza in a susceptible population, but limited attempts have been made to further quantify the association between HI titre and protective efficacy. We present a model, using a meta-analytical approach, that estimates the level of clinical protection against influenza at any HI titre level. Source data were derived from a systematic literature review that identified 15 studies, representing a total of 5899 adult subjects and 1304 influenza cases with interval-censored information on HI titre. The parameters of the relationship between HI titre and clinical protection were estimated using Bayesian inference with a consideration of random effects and censorship in the available information. A significant and positive relationship between HI titre and clinical protection against influenza was observed in all tested models. This relationship was found to be similar irrespective of the type of viral strain (A or B) and the vaccination status of the individuals. Although limitations in the data used should not be overlooked, the relationship derived in this analysis provides a means to predict the efficacy of inactivated influenza vaccines when only immunogenicity data are available. This relationship can also be useful for comparing the efficacy of different influenza vaccines based on their immunological profile.

Development of an intensive care unit resource assessment survey for the care of critically ill patients in resource-limited settings.

PubMed

Leligdowicz, Aleksandra; Bhagwanjee, Satish; Diaz, Janet V; Xiong, Wei; Marshall, John C; Fowler, Robert A; Adhikari, Neill Kj

2017-04-01

Capacity to provide critical care in resource-limited settings is poorly understood because of lack of data about resources available to manage critically ill patients. Our objective was to develop a survey to address this issue. We developed and piloted a cross-sectional self-administered survey in 9 resource-limited countries. The survey consisted of 8 domains; specific items within domains were modified from previously developed survey tools. We distributed the survey by e-mail to a convenience sample of health care providers responsible for providing care to critically ill patients. We assessed clinical sensibility and test-retest reliability. Nine of 15 health care providers responded to the survey on 2 separate occasions, separated by 2 to 4 weeks. Clinical sensibility was high (3.9-4.9/5 on assessment tool). Test-retest reliability for questions related to resource availability was acceptable (intraclass correlation coefficient, 0.94; 95% confidence interval, 0.75-0.99; mean (SD) of weighted κ values = 0.67 [0.19]). The mean (SD) time for survey completion survey was 21 (16) minutes. A reliable cross-sectional survey of available resources to manage critically ill patients can be feasibly administered to health care providers in resource-limited settings. The survey will inform future research focusing on access to critical care where it is poorly described but urgently needed. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Limits of acceptable change planning in the Selway-Bitterroot Wilderness: 1985 to 1997 (FIDL)

Treesearch

Dan Ritter

1997-01-01

In 1985 the Forest Supervisors and staff of the Bitterroot, Clearwater, and Nez Perce National Forests met and agreed to an action plan for implementing a Limits of Acceptable Change (LAC) planning process for the Selway-Bitterroot Wilderness (SBW). The process, which was to include a citizens task force, was to produce a completed management plan in 2 years. Eight...

Understanding the Factors Limiting the Acceptability of Online Courses and Degrees

ERIC Educational Resources Information Center

Adams, Jonathan

2008-01-01

This study examines prior research conducted on the acceptability of online degrees in hiring situations. In a national survey, a questionnaire was developed for assessing the importance of objections to accepting job candidates with online degrees and sent to university search committee chairs in institutions advertising open faculty positions…

Increasing Our Acceptance as Parents of Children with Special Needs

ERIC Educational Resources Information Center

Loewenstein, David

2007-01-01

Accepting the limitations of a child whose life was supposed to be imbued with endless possibilities requires parents to come to terms with expectations of themselves and the world around them. In this article, the author offers some helpful strategies for fostering acceptance and strengthening family relationships: (1) Remember that parenting is…

Limits of acceptable change as tool for tourism development sustainability in Pangandaran West Java

NASA Astrophysics Data System (ADS)

Komsary, K. C.; Tarigan, W. P.; Wiyana, T.

2018-03-01

Pangandaran since 2006 has become a model of sustainable tourism development. A program aimed to empower local communities to prepare work plans and activities to enrich the various potential development of sustainable tourism. By empowering local community, business competition has led to the undesired development of the tourism sector. This becomes the concern of the negative impact of physical changes in the area. This study aims to identify and measure the acceptable changes (limits of acceptable change-LAC) of tourism development in Pangandaran to remain adaptable as a tourist attraction. This study considers how to determine acceptable levels of impact that occurs in the Pangandaran area. This method involves stakeholders in determining the values, issues, and concerns the acceptable levels of impact for this region. The result of acceptance rate then compared with the effects of the current state. Through review and analysis methods used in this study, the LAC situation in Pangandaran outlined. Results from this study are expected to identify indicators of sustainable development of tourism sector through LAC approach.

Pilot Study of Cartilage Repair in the Knee Joint with Multiply Incised Chondral Allograft

PubMed Central

Vancsodi, Jozsef; Farkas, Boglarka; Fazekas, Adam; Nagy, Szilvia Anett; Bogner, Peter; Vermes, Csaba; Than, Peter

2015-01-01

Background Focal cartilage lesions in the knee joint have limited capacity to heal. Current animal experiments show that incisions of the deep zone of a cartilage allograft allow acceptable integration for the graft. Questions/Purposes We performed this clinical study to determine (1) if the multiply incised cartilage graft is surgically applicable for focal cartilage lesions, (2) whether this allograft has a potential to integrate to the repair site, and (3) if patients show clinical improvement. Patients and Methods Seven patients with 8 chondral lesions were enrolled into the study. Symptomatic lesions between 2 and 8 cm2 were accepted. Additional injuries were allowed but were addressed simultaneously. Grafts were tailored to match and the deep zone of the cartilage was multiply incised to augment the basal integration before securing in place. Rigorous postoperative physiotherapy followed. At 12 and 24 months the patients’ satisfaction were measured and serial magnetic resonance imaging (MRI) was performed in 6 patients. Results Following the implantations no adverse reaction occurred. MRI evaluation postoperatively showed the graft in place in 5 out of 6 patients. In 1 patient, MRI suggested partial delamination at 1 year and graft degeneration at 2 years. Short Form–36 health survey and the Lysholm knee score demonstrated a significant improvement in the first year; however, by 2 years there was a noticeable drop in the scores. Conclusions. Multiply incised pure chondral allograft used for cartilage repair appears to be a relatively safe method. Further studies are necessary to assess its potential in cartilage repair before its clinical use. PMID:26069710

SU-E-T-405: Evaluation of the Raystation Electron Monte Carlo Algorithm for Varian Linear Accelerators

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

Sansourekidou, P; Allen, C

2015-06-15

Purpose: To evaluate the Raystation v4.51 Electron Monte Carlo algorithm for Varian Trilogy, IX and 2100 series linear accelerators and commission for clinical use. Methods: Seventy two water and forty air scans were acquired with a water tank in the form of profiles and depth doses, as requested by vendor. Data was imported into Rayphysics beam modeling module. Energy spectrum was modeled using seven parameters. Contamination photons were modeled using five parameters. Source phase space was modeled using six parameters. Calculations were performed in clinical version 4.51 and percent depth dose curves and profiles were extracted to be compared tomore » water tank measurements. Sensitivity tests were performed for all parameters. Grid size and particle histories were evaluated per energy for statistical uncertainty performance. Results: Model accuracy for air profiles is poor in the shoulder and penumbra region. However, model accuracy for water scans is acceptable. All energies and cones are within 2%/2mm for 90% of the points evaluated. Source phase space parameters have a cumulative effect. To achieve distributions with satisfactory smoothness level a 0.1cm grid and 3,000,000 particle histories were used for commissioning calculations. Calculation time was approximately 3 hours per energy. Conclusion: Raystation electron Monte Carlo is acceptable for clinical use for the Varian accelerators listed. Results are inferior to Elekta Electron Monte Carlo modeling. Known issues were reported to Raysearch and will be resolved in upcoming releases. Auto-modeling is limited to open cone depth dose curves and needs expansion.« less

A Quality Assessment of a Collaborative Model of a Pediatric Antimicrobial Stewardship Program.

PubMed

Nguyen-Ha, Phuong-Tan; Howrie, Denise; Crowley, Kelli; Vetterly, Carol G; McGhee, William; Berry, Donald; Ferguson, Elizabeth; Polischuk, Emily; Brooks, Maria Mori; Goff, Jeffrey; Stillwell, Terri; Darville, Toni; Thompson, Ann E; Levin, James E; Michaels, Marian G; Green, Michael

2016-05-01

Infectious Diseases Society of America guidelines recommend that key antimicrobial stewardship program (ASP) personnel include an infectious disease (ID) physician leader and dedicated ID-trained clinical pharmacist. Limited resources prompted development of an alternative model by using ID physicians and service-based clinical pharmacists at a pediatric hospital. The aim of this study was to analyze the effectiveness and impact of this alternative ASP model. The collaborative ASP model incorporated key strategies of education, antimicrobial restriction, day 3 audits, and practice guidelines. High-use and/or high-cost antimicrobial agents were chosen with audits targeting vancomycin, caspofungin, and meropenem. The electronic medical record was used to identify patients requiring day 3 audits and to communicate ASP recommendations. Segmented regression analyses were used to analyze quarterly antimicrobial agent prescription data for the institution and selected services over time. Initiation of ASP and day 3 auditing was associated with blunting of a preexisting increasing trend for caspofungin drug starts and use and a significant downward trend for vancomycin drug starts (relative change -12%) and use (-25%), with the largest reduction in critical care areas. Although meropenem use was already low due to preexisting requirements for preauthorization, a decline in drug use (-31%, P = .021) and a nonsignificant decline in drug starts (-21%, P = .067) were noted. A 3-month review of acceptance of ASP recommendations found rates of 90%, 93%, and 100% for vancomycin, caspofungin, and meropenem, respectively. This nontraditional ASP model significantly reduced targeted drug usage demonstrating acceptance of integration of service-based clinical pharmacists and ID consultants. Copyright © 2016 by the American Academy of Pediatrics.

The patient perspective on remote monitoring of patients with an implantable cardioverter defibrillator: Narrative review and future directions.

PubMed

Timmermans, Ivy; Meine, Matias; Zitron, Edgar; Widdershoven, Jos; Kimman, Geert; Prevot, Sébastien; Rauwolf, Thomas; Anselme, Frédéric; Szendey, Istvan; Romero Roldán, Javier; Mabo, Philippe; Schaer, Beat; Denollet, Johan; Versteeg, Henneke

2017-07-01

Studies have shown that remote patient monitoring (RPM) of implantable cardioverter defibrillators (ICDs) is at least comparable to in-clinic follow-up with regard to clinical outcomes and might be cost-effective, yet RPM is not standard clinical practice within Europe. Better insight into the patient perspective on RPM may aid in its acceptance, implementation, and reimbursement. This narrative review (1) summarizes existing evidence on the impact of RPM on patient-reported outcomes and (2) discusses future directions in examining the patient perspective. Literature review indicated that only five randomized trials on RPM in ICD patients included patient-reported outcomes, with inconclusive results. Observational studies show a trend toward good patient satisfaction and acceptation of RPM. Yet, results should be interpreted with caution due to a number of limitations including a potential selection bias, use of generic/nonvalidated questionnaires, relatively short follow-up durations, and a lack of subgroup identification. Although RPM seems to be safe, effective, timely, and efficient, the patient perspective has received little attention so far. The scarce evidence on patient-reported outcomes in RPM studies seems to be positive, but future trials with a follow-up of ≥12 months and validated patient-reported outcome measures are needed. The REMOTE-CIED study from our group is the first prospective randomized controlled trial primarily designed to examine the patient perspective on RPM, and is powered to identify characteristics associated with RPM satisfaction and benefit. Results are expected in 2018 and will add valuable information to the current evidence. © 2017 Wiley Periodicals, Inc.

A Multistep Maturity Model for the Implementation of Electronic and Computable Diagnostic Clinical Prediction Rules (eCPRs).

PubMed

Corrigan, Derek; McDonnell, Ronan; Zarabzadeh, Atieh; Fahey, Tom

2015-01-01

The use of Clinical Prediction Rules (CPRs) has been advocated as one way of implementing actionable evidence-based rules in clinical practice. The current highly manual nature of deriving CPRs makes them difficult to use and maintain. Addressing the known limitations of CPRs requires implementing more flexible and dynamic models of CPR development. We describe the application of Information and Communication Technology (ICT) to provide a platform for the derivation and dissemination of CPRs derived through analysis and continual learning from electronic patient data. We propose a multistep maturity model for constructing electronic and computable CPRs (eCPRs). The model has six levels - from the lowest level of CPR maturity (literaturebased CPRs) to a fully electronic and computable service-oriented model of CPRs that are sensitive to specific demographic patient populations. We describe examples of implementations of the core model components - focusing on CPR representation, interoperability, electronic dissemination, CPR learning, and user interface requirements. The traditional focus on derivation and narrow validation of CPRs has severely limited their wider acceptance. The evolution and maturity model described here outlines a progression toward eCPRs consistent with the vision of a learning health system (LHS) - using central repositories of CPR knowledge, accessible open standards, and generalizable models to avoid repetition of previous work. This is useful for developing more ambitious strategies to address limitations of the traditional CPR development life cycle. The model described here is a starting point for promoting discussion about what a more dynamic CPR development process should look like.

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.

Issues and approaches for ensuring effective communication on acceptable daily exposure (ADE) values applied to pharmaceutical cleaning.

PubMed

Olson, Michael J; Faria, Ellen C; Hayes, Eileen P; Jolly, Robert A; Barle, Ester Lovsin; Molnar, Lance R; Naumann, Bruce D; Pecquet, Alison M; Shipp, Bryan K; Sussman, Robert G; Weideman, Patricia A

2016-08-01

This manuscript centers on communication with key stakeholders of the concepts and program goals involved in the application of health-based pharmaceutical cleaning limits. Implementation of health-based cleaning limits, as distinct from other standards such as 1/1000th of the lowest clinical dose, is a concept recently introduced into regulatory domains. While there is a great deal of technical detail in the written framework underpinning the use of Acceptable Daily Exposures (ADEs) in cleaning (for example ISPE, 2010; Sargent et al., 2013), little is available to explain how to practically create a program which meets regulatory needs while also fulfilling good manufacturing practice (GMP) and other expectations. The lack of a harmonized approach for program implementation and communication across stakeholders can ultimately foster inappropriate application of these concepts. Thus, this period in time (2014-2017) could be considered transitional with respect to influencing best practice related to establishing health-based cleaning limits. Suggestions offered in this manuscript are intended to encourage full and accurate communication regarding both scientific and administrative elements of health-based ADE values used in pharmaceutical cleaning practice. This is a large and complex effort that requires: 1) clearly explaining key terms and definitions, 2) identification of stakeholders, 3) assessment of stakeholders' subject matter knowledge, 4) formulation of key messages fit to stakeholder needs, 5) identification of effective and timely means for communication, and 6) allocation of time, energy, and motivation for initiating and carrying through with communications. Copyright © 2016 Elsevier Inc. All rights reserved.

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.

Internal quality assurance in a clinical virology laboratory. II. Internal quality control.

PubMed Central

Gray, J J; Wreghitt, T G; McKee, T A; McIntyre, P; Roth, C E; Smith, D J; Sutehall, G; Higgins, G; Geraghty, R; Whetstone, R

1995-01-01

AIMS--In April 1991 additional quality control procedures were introduced into the virology section of the Clinical Microbiology and Public Health Laboratory, Cambridge. Internal quality control (IQC) samples were gradually included in the serological assays performed in the laboratory and supplemented kit controls and standard sera. METHODS--From April 1991 to December 1993, 2421 IQC procedures were carried out with reference sera. RESULTS--The IQC samples were evaluated according to the Westgard rules. Violations were recorded in 60 of 1808 (3.3%) controls and were highest in the IQC samples of complement fixation tests (25/312 (8%) of controls submitted for complement fixation tests). CONCLUSIONS--The inclusion of IQC samples in the serological assays performed in the laboratory has highlighted batch to batch variation in commercial assays. The setting of acceptable limits for the IQC samples has increased confidence in the validity of assay results. PMID:7730475

Vascular Anomalies.

PubMed

Taghinia, Amir H; Upton, Joseph

2018-06-12

Vascular anomalies encompass a wide variety of clinical conditions involving the vasculature. Over the past several decades, the terminology has changed as our understanding of these conditions has improved. A well-accepted classification scheme has evolved with constant additions, updates, and revisions. Imaging techniques have also advanced with greater resolution and a better understanding of the correlation between imaging, clinical behavior, and natural history. Meanwhile, the treatment of these conditions has also changed, with greater focus on minimally invasive techniques as opposed to radical surgery. Despite these changes, surgical intervention remains a high-value option for select patients. With greater understanding of the molecular basis of these diseases, medical treatment has improved especially in severe cases where options remain limited. A multidisciplinary approach to comprehensive patient care usually yields the best outcome and is strongly encouraged. Copyright © 2018 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

Novel Uses for the Anabolic Androgenic Steroids Nandrolone and Oxandrolone in the Management of Male Health.

PubMed

Wu, Christopher; Kovac, Jason R

2016-10-01

There has recently been renewed interest in novel clinical applications of the anabolic-androgenic steroid (AAS) testosterone and its synthetic derivatives, particularly given with the rising popularity of testosterone supplementation therapy (TST) for the treatment of male hypogonadism. In this manuscript, we provide a brief review of the history of AAS and discuss clinical applications of two of the more well-known AAS: nandrolone and oxandrolone. Both agents exhibit favorable myotrophic/androgenic ratios and have been investigated for effectiveness in numerous disease states. We also provide a brief synopsis of selective androgen receptor modulators (SARMs) and postulate how these orally active, non-aromatizing, tissue-selective agents might be used in contemporary andrology. Currently, the applications of testosterone alternatives in hypogonadism are limited. However, it is tempting to speculate that these agents may one day become accepted as alternatives, or adjuncts, to the treatment of male hypogonadism.

Rethinking the model of osteoarthritis: a clinical viewpoint.

PubMed

Wade, Greg J

2011-11-01

The prevailing model of joint degeneration based on age-related, genetic, and familial factors implies inevitable progression and limited palliation from manual therapy. This model is presented to primary care physicians and the public on Web sites and in resource texts and is implicit in many published research articles. The author presents a synthesized model of the progression of osteoarthritis, combining radiographic, histologic, and clinical evidence. The revised model suggests that the progression of primary osteoarthritis is divided into an initial reversible arthrosis phase and a later arthritis phase, with both phases linked to accepted histologic and radiographic observations. The revised model also suggests a number of novel concepts, including the influence of dominance bias and laterality. The author concludes that a small change in understanding could translate into important changes in the therapeutic management of osteoarthritis, with implications for government public health policy.

WASP (Write a Scientific Paper): Special cases of selective non-treatment and/or DNR.

PubMed

Mallia, Pierre

2018-05-03

Fetuses at low gestational age limit of viability, neonates with life threatening or life limiting congenital anomalies and deteriorating acutely ill newborn babies in intensive care, pose taxing ethical questions on whether to forego or stop treatment and allow them to die naturally. Although there is essentially no ethical difference between end of life decision between neonates and other children and adults, in the former, the fact that we are dealing with a new life, may pose greater problems to staff and parents. Good communication skills and involvement of all the team and the parents should start from the beginning to see which treatment can be foregone or stopped in the best interests of the child. This article deals with the importance of clinical ethics to avoid legal and moral showdowns and discusses accepted moral practice in this difficult area. Copyright © 2018. Published by Elsevier B.V.

Computer-Interpreted Electrocardiograms: Benefits and Limitations.

PubMed

Schläpfer, Jürg; Wellens, Hein J

2017-08-29

Computerized interpretation of the electrocardiogram (CIE) was introduced to improve the correct interpretation of the electrocardiogram (ECG), facilitating health care decision making and reducing costs. Worldwide, millions of ECGs are recorded annually, with the majority automatically analyzed, followed by an immediate interpretation. Limitations in the diagnostic accuracy of CIE were soon recognized and still persist, despite ongoing improvement in ECG algorithms. Unfortunately, inexperienced physicians ordering the ECG may fail to recognize interpretation mistakes and accept the automated diagnosis without criticism. Clinical mismanagement may result, with the risk of exposing patients to useless investigations or potentially dangerous treatment. Consequently, CIE over-reading and confirmation by an experienced ECG reader are essential and are repeatedly recommended in published reports. Implementation of new ECG knowledge is also important. The current status of automated ECG interpretation is reviewed, with suggestions for improvement. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Infection, Alveolar Osteitis, and Adverse Effects Using Metronidazole in Healthy Patients Undergoing Third Molar Surgery: A Meta-analysis.

PubMed

Isiordia-Espinoza, Mario Alberto; Aragon-Martinez, Othoniel H; Bollogna-Molina, Ronell E; Alonso-Castro, Ángel J

2018-06-01

The aim of this systematic review and meta-analysis was to evaluate the risk of surgical infection, alveolar osteitis, and adverse effects using systemic metronidazole in comparison with placebo in healthy patients undergoing third molar surgery. The eligible reports were identified from diverse science sources. Clinical trials meeting the inclusion and exclusion criteria and an acceptable Oxford Quality Score were included in this study. The evaluation of risk was done using the Risk Reduction Calculator and Review Manager 5.3., from the Cochrane Library. A significant risk reduction was assumed when the upper limit of the 95% confidence intervals was <1 and the lower limit did not cross zero (negative number) alongside a p value of <0.05 for the overall test. Data of 667 patients from five clinical trials were used for the assessment of risk. Our analysis showed no reduction of the risk of infection or dry socket in patients receiving metronidazole compared to whom took placebo. Meanwhile, the adverse effects did not exhibit a difference between the studied groups. The routine use of systemic metronidazole to prevent surgical site infection and/or dry socket in healthy patients undergoing third molar surgery is not recommended.

Current Status and Future Prospects for Esophageal Cancer Treatment

PubMed Central

Kuwano, Hiroyuki

2016-01-01

The local control effect of esophagectomy with three-field lymph node dissection (3FLD) is reaching its limit pending technical advancement. Minimally invasive esophagectomy (MIE) by thoracotomy is slowly gaining acceptance due to advantages in short-term outcomes. Although the evidence is slowly increasing, MIE is still controversial. Also, the results of treatment by surgery alone are limiting, and multimodality therapy, which includes surgical and non-surgical treatment options including chemotherapy, radiotherapy, and endoscopic treatment, has become the mainstream therapy. Esophagectomy after neoadjuvant chemotherapy (NAC) is the standard treatment for clinical stages II/III (except for T4) esophageal cancer, whereas chemoradiotherapy (CRT) is regarded as the standard treatment for patients who wish to preserve their esophagus, those who refuse surgery, and those with inoperable disease. CRT is also usually selected for clinical stage IV esophageal cancer. On the other hand, with the spread of CRT, salvage esophagectomy has traditionally been recognized as a feasible option; however, many clinicians oppose the use of surgery due to the associated unfavorable morbidity and mortality profile. In the future, the improvement of each treatment result and the establishment of individual strategies are important although esophageal cancer has many treatment options. PMID:28003586

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).

Do one-time intracompartmental pressure measurements have a high false-positive rate in diagnosing compartment syndrome?

PubMed

Whitney, Augusta; O'Toole, Robert V; Hui, Emily; Sciadini, Marcus F; Pollak, Andrew N; Manson, Theodore T; Eglseder, W Andrew; Andersen, Romney C; Lebrun, Christopher; Doro, Christopher; Nascone, Jason W

2014-02-01

Intracompartmental pressure measurements are frequently used in the diagnosis of compartment syndrome, particularly in patients with equivocal or limited physical examination findings. Little clinical work has been done to validate the clinical use of intracompartmental pressures or identify associated false-positive rates. We hypothesized that diagnosis of compartment syndrome based on one-time pressure measurements alone is associated with a high false-positive rate. Forty-eight consecutive patients with tibial shaft fractures who were not suspected of having compartment syndrome based on physical examinations were prospectively enrolled. Pressure measurements were obtained in all four compartments at a single point in time immediately after induction of anesthesia using a pressure-monitoring device. Preoperative and intraoperative blood pressure measurements were recorded. The same standardized examination was performed by the attending surgeon preoperatively, postoperatively, and during clinical follow-up for 6 months to assess clinical evidence of acute or late compartment syndrome. No clinical evidence of compartment syndrome was observed postoperatively or during follow-up until 6 months after injury. Using the accepted criteria of delta P of 30 mm Hg from preoperative diastolic blood pressure, 35% of cases (n = 16; 95% confidence interval, 21.5-48.5%) met criteria for compartment syndrome. Raising the threshold to delta P of 20 mm Hg reduced the false-positive rate to 24% (n = 11; 95% confidence interval, 11.1-34.9%). Twenty-two percent (n = 10; 95% confidence interval, 9.5-32.5%) exceeded absolute pressure of 45 mm Hg. A 35% false-positive rate was found for the diagnosis of compartment syndrome in patients with tibial shaft fractures who were not thought to have compartment syndrome by using currently accepted criteria for diagnosis based solely on one-time compartment pressure measurements. Our data suggest that reliance on one-time intracompartmental pressure measurements can overestimate the rate of compartment syndrome and raise concern regarding unnecessary fasciotomies. Diagnostic study, level II.

Examining the Moderating Effect of Individual-Level Cultural Values on Users' Acceptance of E-Learning in Developing Countries: A Structural Equation Modeling of an Extended Technology Acceptance Model

ERIC Educational Resources Information Center

Tarhini, Ali; Hone, Kate; Liu, Xiaohui; Tarhini, Takwa

2017-01-01

In this study, we examine the effects of individual-level culture on the adoption and acceptance of e-learning tools by students in Lebanon using a theoretical framework based on the Technology Acceptance Model (TAM). To overcome possible limitations of using TAM in developing countries, we extend TAM to include "subjective norms" (SN)…

Hybrid vehicle control

DOEpatents

Shallvari, Iva; Velnati, Sashidhar; DeGroot, Kenneth P.

2015-07-28

A method and apparatus for heating a catalytic converter's catalyst to an efficient operating temperature in a hybrid electric vehicle when the vehicle is in a charge limited mode such as e.g., the charge depleting mode or when the vehicle's high voltage battery is otherwise charge limited. The method and apparatus determine whether a high voltage battery of the vehicle is incapable of accepting a first amount of charge associated with a first procedure to warm-up the catalyst. If it is determined that the high voltage battery is incapable of accepting the first amount of charge, a second procedure with an acceptable amount of charge is performed to warm-up the catalyst.

Influence of multiple brain metastases’ size and number on the quality of SRS - VMAT dose delivery

NASA Astrophysics Data System (ADS)

Prentou, G.; Koutsouveli, E.; Pantelis, E.; Papagiannis, P.; Georgiou, E.; Karaiskos, P.

2017-11-01

Stereotactic radiosurgery with volumetric modulated arc therapy (SRS-VMAT) has recently been introduced for treatment of multiple brain metastases with a single isocenter. The technique’s high efficiency is nevertheless dependent of metastatic tumors’ characteristics such as size and number. In this work the impact of the metastases’ size and number on the plan quality indices clinically used for plan evaluation and acceptance is investigated. Fifteen targets with a diameter of 1 cm and average volume of 0.7 cm3 and ten targets with a diameter of 2 cm and average volume of 6.5 cm3 were contoured on an anonymized patient CT dataset, in Monaco (Elekta) treatment planning system. VMAT plans for different target volumes (1 and 2 cm in diameter) and various target numbers (1-15) were generated using four non-coplanar arcs and the Agility (Elekta) linear accelerator (5 mm MLC width) using a Monte Carlo dose calculation algorithm and 1mm dose calculation grid resolution. Conformity index (CI), gradient index (GI) and heterogeneity index (HI) were determined for each target. High quality plans were created for both 1 cm and 2 cm in diameter targets for limited (<6) number of targets per plan. For increased number of irradiated targets (>6) both CI and GI, clinically used for plan evaluation and acceptance, were found to deteriorate.

Perceptions of nursing students regarding responsible use of social media in the Eastern Cape.

PubMed

Nyangeni, Thando; Du Rand, Suzette; Van Rooyen, Dalena

2015-07-24

Social media have become a popular communication system that has transformed communication from the traditional to the Web-based model. Because social media use has no limitations to place and time, it is now used extensively at clinical facilities. Social media useis becoming a popular activity amongst students at Nursing Education Institutions (NEI) in South Africa. However, lack of accountability and unethical use of social media by nursing students in South Africa has been reported. The aim of the study was to explore and describe the perceptions of nursing students regarding responsible use of social media. A qualitative, descriptive, explorative and contextual research design was used to explore and describe the perceptions of nursing students regarding the responsible use of social media. Twelve nursing students registered for the undergraduate nursing degree were purposely selected and interviewed individually using a semi-structured interview method. The results of this research study demonstrate that nursing students use socialmedia irresponsibly. Nursing students experience blurred boundaries between personal and professional lines and lack accountability when using social media. The extensive use of social media in the clinical environment, by healthcare students, requires a joint effort by Nursing Education Institutions and healthcare facilities to ensure that social media are used in an ethically acceptable manner. The implementation of the recommendations of this research study could positively influence legally and ethically acceptable use of social media at healthcare facilities.

Charging performance of automotive batteries-An underestimated factor influencing lifetime and reliable battery operation

NASA Astrophysics Data System (ADS)

Sauer, Dirk Uwe; Karden, Eckhard; Fricke, Birger; Blanke, Holger; Thele, Marc; Bohlen, Oliver; Schiffer, Julia; Gerschler, Jochen Bernhard; Kaiser, Rudi

Dynamic charge acceptance and charge acceptance under constant voltage charging conditions are for two reasons essential for lead-acid battery operation: energy efficiency in applications with limited charging time (e.g. PV systems or regenerative braking in vehicles) and avoidance of accelerated ageing due to sulphation. Laboratory tests often use charge regimes which are beneficial for the battery life, but which differ significantly from the operating conditions in the field. Lead-acid batteries in applications with limited charging time and partial-state-of-charge operation are rarely fully charged due to their limited charge acceptance. Therefore, they suffer from sulphation and early capacity loss. However, when appropriate charging strategies are applied most of the lost capacity and thus performance for the user may be recovered. The paper presents several aspects of charging regimes and charge acceptance. Theoretical and experimental investigations show that temperature is the most critical parameter. Full charging within short times can be achieved only at elevated temperatures. A strong dependency of the charge acceptance during charging pulses on the pre-treatment of the battery can be observed, which is not yet fully understood. But these effects have a significant impact on the fuel efficiency of micro-hybrid electric vehicles.

Patients' Perspectives and Experiences Living with Systemic Sclerosis: A Systematic Review and Thematic Synthesis of Qualitative Studies.

PubMed

Nakayama, Ayano; Tunnicliffe, David J; Thakkar, Vivek; Singh-Grewal, Davinder; O'Neill, Sean; Craig, Jonathan C; Tong, Allison

2016-07-01

Systemic sclerosis (SSc) is a chronic, progressive autoimmune disease with major end-organ involvement. Much attention has been focused on the management of physical and clinical manifestations; however, the effect of the disease and treatment on the patient's identity, relationships, functioning, and mental well-being are less known. We aimed to describe the patients' perspectives and experiences of living with SSc. Electronic databases were searched to October 2014. Thematic synthesis was used to analyze the findings. We included 26 studies involving 463 patients. Six key themes were identified: distressing appearance transformation (disturbing facial changes, stigmatizing sickness, unrecognizable self), palpable physical limitations (bodily restrictions, frustrating mind-body disconnect, pervasive fatigue, disabling pain), social impairment (breaking intimacy, struggling to fulfill family responsibilities, maintaining work, losing independence), navigating uncertainty (diagnostic ambiguity, medically fending for oneself, unpredictable course of illness), alone and misunderstood (fearful avoidance of fellow patients, invisible suffering), and gradual acceptance and relative optimism (adapting to change and accepting limitations, taking a positive spin, cautious hoping, empowering relationships, valuing medical support). SSc is a rare and unpredictable illness that undermines patients' sense of certainty and control and impairs their self-image, identity, and daily functioning. Patient-centered care that encompasses strategies to promote self-esteem, resilience, and self-efficacy may help to improve treatment satisfaction and health and quality of life outcomes for patients with SSc.

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.

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

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.

Concise Review: Endothelial Progenitor Cells in Regenerative Medicine: Applications and Challenges

PubMed Central

Chong, Mark Seow Khoon; Ng, Wei Kai

2016-01-01

Endothelial progenitor cells (EPCs) are currently being studied as candidate cell sources for revascularization strategies. Significant advances have been made in understanding the biology of EPCs, and preclinical studies have demonstrated the vasculogenic, angiogenic, and beneficial paracrine effects of transplanted EPCs in the treatment of ischemic diseases. Despite these promising results, widespread clinical acceptance of EPCs for clinical therapies remains hampered by several challenges. The present study provides a concise summary of the different EPC populations being studied for ischemic therapies and their known roles in the healing of ischemic tissues. The challenges and issues surrounding the use of EPCs and the current strategies being developed to improve the harvest efficiency and functionality of EPCs for application in regenerative medicine are discussed. Significance Endothelial progenitor cells (EPCs) have immense clinical value for cardiovascular therapies. The present study provides a concise description of the EPC subpopulations being evaluated for clinical applications. The current major lines of investigation involving preclinical and clinical evaluations of EPCs are discussed, and significant gaps limiting the translation of EPCs are highlighted. The present report could be useful for clinicians and clinical researchers with interests in ischemic therapy and for basic scientists working in the related fields of tissue engineering and regenerative medicine. PMID:26956207

False memories, negative affects, and psychic reality: the role of extra-clinical data in psychoanalysis.

PubMed

Good, Michael I; Dayand, Max; Rowell, Eve

2005-12-01

Psychoanalysis as a treatment originated in the idea that neurosis is related to the ways in which individual psychic reality departs from actuality. Psychic reality includes memories, beliefs and their associated affects and fantasies connected with an individual's experience of the inner and outer world. The psychoanalytic determination of what meaningful memories or beliefs are inaccurate, distorted or false ordinarily relies upon principles of intra-clinical validation. By itself, however, intra-clinical validation is subject to limitations and pitfalls that conviction alone about what is actual cannot circumvent. Despite this fact, there are remarkably few analytic case reports demonstrating false or significantly distorted memories through the use of data obtained from outside the consulting room. This paucity of reports may be related, at least in part, to the belief that the use of extra-clinical data is essentially unanalytic or supports resistance. Based on the views that (a) psychic reality cannot be regarded as exclusively subjective or objective but is inherently both; and that (b) a goal of analysis is to achieve a different, acceptable and more accurate view of reality, the authors report a clinical case involving a confirmably false pivotal memory and its associated negative affects. They discuss theoretical and technical considerations in utilizing extra-clinical data during the treatment process.

Technological challenges of theranostics in oncology.

PubMed

Warenius, Hilmar M

2009-07-01

Although the term theranostics has been coined only fairly recently, attempts to relate the level of biomarkers to therapeutic response in the oncology clinic go back several decades. After a long period in which a limited number of individual theranostic molecular biomarkers gained general clinical acceptance, extremely powerful genomic and proteomic technologies have now emerged. These technologies, reviewed here, promise a potential revolution in our ability to predict therapeutic response in cancer, and by so doing, guide new anticancer drugs more successfully into clinical oncology practice. A full understanding of the detailed molecular nature of clinical cancer is, however, still evolving. The need for appropriate models of the highly complex disease, against which we are attempting to direct effective therapy more accurately, is also addressed. These should include an understanding of genomic and proteomic heterogeneity, genetic instability and systems biology models of cancer that take into account recent demonstrations of the vastly increased mutational state of the average clinical cancer as compared with the normal cell(s) from which it arose. The way forward in theranostics is, arguably, less dependent on further improvements in the already powerful genomic and proteomic technologies themselves than on our improved understanding of how we should apply them to the complex reality of the average clinical cancer.

A telehealth approach to conducting clinical swallowing evaluations in children with cerebral palsy.

PubMed

Kantarcigil, Cagla; Sheppard, Justine Joan; Gordon, Andrew M; Friel, Kathleen M; Malandraki, Georgia A

2016-08-01

Accurate and timely evaluation of dysphagia in children with cerebral palsy (CP) is critical. For children with limited access to quality healthcare, telehealth is an option; however, its reliability needs to be investigated. To test the reliability of an asynchronous telehealth model for evaluating dysphagia in children with CP using a standardized clinical assessment. Nineteen children (age range 6.9-17.5) were assessed at three mealtimes via the Dysphagia Disorder Survey (DDS) by three clinicians (face-to-face evaluations). Mealtimes were video-recorded to allow asynchronous evaluations by a remote clinician who also completed approximately 1/3 of face-to-face evaluations. Agreement was tested on DDS variables and dysphagia severity. Results revealed substantial to excellent agreement between face-to-face and remote assessments by the same rater (78-100%, KW=0.64-1) on all, but two variables (oral transport and oral pharyngeal swallow) and by different raters (69-89%, KW=0.6-0.86) on all but one variable (orienting). For dysphagia severity, intrarater agreement was excellent (100%, KW=1); interrater agreement was substantial (85%; KW=0.76). Asynchronous clinical swallowing evaluations using standardized tools have acceptable levels of agreement with face-to-face evaluations, and can be an alternative for children with limited access to expert swallowing care. Copyright © 2016 Elsevier Ltd. All rights reserved.

Development of In Vitro-In Vivo Correlation for Amorphous Solid Dispersion Immediate-Release Suvorexant Tablets and Application to Clinically Relevant Dissolution Specifications and In-Process Controls.

PubMed

Kesisoglou, Filippos; Hermans, Andre; Neu, Colleen; Yee, Ka Lai; Palcza, John; Miller, Jessica

2015-09-01

Although in vitro-in vivo correlations (IVIVCs) are commonly pursued for modified-release products, there are limited reports of successful IVIVCs for immediate-release (IR) formulations. This manuscript details the development of a Multiple Level C IVIVC for the amorphous solid dispersion formulation of suvorexant, a BCS class II compound, and its application to establishing dissolution specifications and in-process controls. Four different 40 mg batches were manufactured at different tablet hardnesses to produce distinct dissolution profiles. These batches were evaluated in a relative bioavailability clinical study in healthy volunteers. Although no differences were observed for the total exposure (AUC) of the different batches, a clear relationship between dissolution and Cmax was observed. A validated Multiple Level C IVIVC against Cmax was developed for the 10, 15, 20, 30, and 45 min dissolution time points and the tablet disintegration time. The relationship established between tablet tensile strength and dissolution was subsequently used to inform suitable tablet hardness ranges within acceptable Cmax limits. This is the first published report for a validated Multiple Level C IVIVC for an IR solid dispersion formulation demonstrating how this approach can facilitate Quality by Design in formulation development and help toward clinically relevant specifications and in-process controls. © 2015 Wiley Periodicals, Inc. and the American Pharmacists Association.

Advance in plasma SEPT9 gene methylation assay for colorectal cancer early detection

PubMed Central

Wang, Yu; Chen, Pei-Min; Liu, Rong-Bin

2018-01-01

This review article summarizes the research advances of the plasma-based SEPT9 gene methylation assay for the clinical detection of colorectal cancer and its limitations. Colorectal cancer is a common malignancy with a poor prognosis and a high mortality, for which early detection and diagnosis are particularly crucial for the high-risk groups. Increasing evidence supported that SEPT9 gene methylation is associated with the pathogenesis of colorectal cancer and that detecting the level of methylation of SEPT9 in the peripheral blood can be used for screening of colorectal cancer in susceptible populations. In recent years, the data obtained in clinical studies demonstrated that the SEPT9 gene methylation assay has a good diagnostic performance with regard to both sensitivity and specificity with the advantage of better acceptability, convenience and compliance with serological testing compared with fecal occult blood tests and carcinoembryonic antigen for colorectal cancer (CRC). Furthermore, the combination of multiple methods or markers has become a growing trend for CRC detection and screening. Nevertheless, the clinical availability of the methylated SEPT9 assay is still limited because of the large degree of sample heterogeneity caused by demographic characteristics, pathological features, comorbidities and/or technique selection. Another factor is the cost-effectiveness of colorectal cancer screening strategies that hinders its large-scale application. In addition, improvements in its accuracy in detecting adenomas and premalignant polyps are required. PMID:29375744

Advance in plasma SEPT9 gene methylation assay for colorectal cancer early detection.

PubMed

Wang, Yu; Chen, Pei-Min; Liu, Rong-Bin

2018-01-15

This review article summarizes the research advances of the plasma-based SEPT9 gene methylation assay for the clinical detection of colorectal cancer and its limitations. Colorectal cancer is a common malignancy with a poor prognosis and a high mortality, for which early detection and diagnosis are particularly crucial for the high-risk groups. Increasing evidence supported that SEPT9 gene methylation is associated with the pathogenesis of colorectal cancer and that detecting the level of methylation of SEPT9 in the peripheral blood can be used for screening of colorectal cancer in susceptible populations. In recent years, the data obtained in clinical studies demonstrated that the SEPT9 gene methylation assay has a good diagnostic performance with regard to both sensitivity and specificity with the advantage of better acceptability, convenience and compliance with serological testing compared with fecal occult blood tests and carcinoembryonic antigen for colorectal cancer (CRC). Furthermore, the combination of multiple methods or markers has become a growing trend for CRC detection and screening. Nevertheless, the clinical availability of the methylated SEPT9 assay is still limited because of the large degree of sample heterogeneity caused by demographic characteristics, pathological features, comorbidities and/or technique selection. Another factor is the cost-effectiveness of colorectal cancer screening strategies that hinders its large-scale application. In addition, improvements in its accuracy in detecting adenomas and premalignant polyps are required.

Methodological challenges for the evaluation of clinical effectiveness in the context of accelerated regulatory approval: an overview.

PubMed

Woolacott, Nerys; Corbett, Mark; Jones-Diette, Julie; Hodgson, Robert

2017-10-01

Regulatory authorities are approving innovative therapies with limited evidence. Although this level of data is sufficient for the regulator to establish an acceptable risk-benefit balance, it is problematic for downstream health technology assessment, where assessment of cost-effectiveness requires reliable estimates of effectiveness relative to existing clinical practice. Some key issues associated with a limited evidence base include using data, from nonrandomized studies, from small single-arm trials, or from single-center trials; and using surrogate end points. We examined these methodological challenges through a pragmatic review of the available literature. Methods to adjust nonrandomized studies for confounding are imperfect. The relative treatment effect generated from single-arm trials is uncertain and may be optimistic. Single-center trial results may not be generalizable. Surrogate end points, on average, overestimate treatment effects. Current methods for analyzing such data are limited, and effectiveness claims based on these suboptimal forms of evidence are likely to be subject to significant uncertainty. Assessments of cost-effectiveness, based on the modeling of such data, are likely to be subject to considerable uncertainty. This uncertainty must not be underestimated by decision makers: methods for its quantification are required and schemes to protect payers from the cost of uncertainty should be implemented. Crown Copyright © 2017. Published by Elsevier Inc. All rights reserved.

Critical appraisal of the top-down approach for vesicoureteral reflux.

PubMed

Abdelhalim, Ahmed; Khoury, Antoine E

2017-06-01

Vesicoureteral reflux (VUR) has been linked to recurrent urinary tract infections (UTIs), renal scarring, hypertension, renal insufficiency and end-stage kidney disease. Different imaging strategies have been proposed to approach children presenting with UTI to sort out patients with significant VUR while minimizing patient morbidity, radiation exposure and financial burden. None of these imaging strategies is universally accepted. The"top-down approach" (TDA) aims at restricting the number of voiding cystourethrograms (VCUGs) and its associated morbidity while identifying patients with clinically-significant reflux. In this approach, children presenting with febrile UTIs are acutely investigated with dimercapto-succinic acid (DMSA) renal scans to identify patients with renal parenchymal inflammation. Those with evidence of renal affection are offered VCUG and late DMSA scan to identify VUR and permanent renal scarring, respectively. Although TDA could identify clinically-significant VUR with high sensitivity, it is not without limitations. The approach segregates patients based on the presence of DMSA cortical lesions omitting the morbidity and the economic burden of UTI. Additionally, some of DMSA lesions are attributed to congenital dysplasia and unrelated to UTI. Ionizing radiation exposure, financial costs, limited availability of DMSA scans in the acute setting, variability in interpreting the results and low yield of actionable findings on DMSA scans are some other limitations. In this review, we tried to address the drawbacks of the TDA and reinforce the value of patient-centered approach for VUR.

Critical appraisal of the top-down approach for vesicoureteral reflux

PubMed Central

Abdelhalim, Ahmed

2017-01-01

Vesicoureteral reflux (VUR) has been linked to recurrent urinary tract infections (UTIs), renal scarring, hypertension, renal insufficiency and end-stage kidney disease. Different imaging strategies have been proposed to approach children presenting with UTI to sort out patients with significant VUR while minimizing patient morbidity, radiation exposure and financial burden. None of these imaging strategies is universally accepted. The“top-down approach” (TDA) aims at restricting the number of voiding cystourethrograms (VCUGs) and its associated morbidity while identifying patients with clinically-significant reflux. In this approach, children presenting with febrile UTIs are acutely investigated with dimercapto-succinic acid (DMSA) renal scans to identify patients with renal parenchymal inflammation. Those with evidence of renal affection are offered VCUG and late DMSA scan to identify VUR and permanent renal scarring, respectively. Although TDA could identify clinically-significant VUR with high sensitivity, it is not without limitations. The approach segregates patients based on the presence of DMSA cortical lesions omitting the morbidity and the economic burden of UTI. Additionally, some of DMSA lesions are attributed to congenital dysplasia and unrelated to UTI. Ionizing radiation exposure, financial costs, limited availability of DMSA scans in the acute setting, variability in interpreting the results and low yield of actionable findings on DMSA scans are some other limitations. In this review, we tried to address the drawbacks of the TDA and reinforce the value of patient-centered approach for VUR. PMID:28612056

Feasibility, Benefits, and Limitations of a Penicillin Allergy Skin Testing Service.

PubMed

Narayanan, Prasanna P; Jeffres, Meghan N

2017-06-01

To critically examine the feasibility, benefits, and limitations of an inpatient penicillin skin testing service and how pharmacists can be utilized. A PubMed search was performed from July 2016 through September 2016 using the following search terms: penicillin skin testing, penicillin allergy, β-lactam allergy. Additional references were identified from a review of literature citations. All English-language studies assessing the use of penicillin skin testing as well as management and clinical outcomes of patients with a β-lactam allergy were evaluated. The prevalence of people self-identifying as penicillin allergic ranges from 10% to 20% in the United States. Being improperly labeled as penicillin allergic is associated with higher health care costs, worse clinical outcomes, and an increased prevalence of multidrug-resistant infections. Penicillin skin testing can be a tool used to clarify penicillin allergies and has been demonstrated to be a successful addition to antimicrobial stewardship programs in multiple health care settings. Prior to implementing a penicillin skin testing service, institutions will need to perform a feasibility analysis of who will supply labor and accept the financial burden as well as identify if the positive benefits of a penicillin skin testing service overcome the limitations of this diagnostic test. We conclude that institutions with high percentages of patients receiving non-β-lactams because of penicillin allergy labels would likely benefit the most from a penicillin skin testing service.

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.

A Feminine Care Clinical Research Program Transforms Women's Lives.

PubMed

Tzeghai, Ghebre E; Ajayi, Funmilayo O; Miller, Kenneth W; Imbescheid, Frank; Sobel, Jack D; Farage, Miranda A

2012-12-17

Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer's quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer's well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met.

Protocol investigating the clinical utility of an objective measure of activity and attention (QbTest) on diagnostic and treatment decision-making in children and young people with ADHD-'Assessing QbTest Utility in ADHD' (AQUA): a randomised controlled trial.

PubMed

Hall, Charlotte L; Walker, Gemma M; Valentine, Althea Z; Guo, Boliang; Kaylor-Hughes, Catherine; James, Marilyn; Daley, David; Sayal, Kapil; Hollis, Chris

2014-12-01

The National Institute for Health and Care Excellence (NICE) guidelines for attention deficit/hyperactivity disorder (ADHD) state that young people need to have access to the best evidence-based care to improve outcome. The current 'gold standard' ADHD diagnostic assessment combines clinical observation with subjective parent, teacher and self-reports. In routine practice, reports from multiple informants may be unavailable or contradictory, leading to diagnostic uncertainty and delay. The addition of objective tests of attention and activity may help reduce diagnostic uncertainty and delays in initiating treatment leading to improved outcomes. This trial investigates whether providing clinicians with an objective report of levels of attention, impulsivity and activity can lead to an earlier, and more accurate, clinical diagnosis and improved patient outcome. This multisite randomised controlled trial will recruit young people (aged 6-17 years old) who have been referred for an ADHD diagnostic assessment at Child and Adolescent Mental Health Services (CAMHS) and Community Paediatric clinics across England. Routine clinical assessment will be augmented by the QbTest, incorporating a continuous performance test (CPT) and infrared motion tracking of activity. The participant will be randomised into one of two study arms: QbOpen (clinician has immediate access to a QbTest report): QbBlind (report is withheld until the study end). Primary outcomes are time to diagnosis and diagnostic accuracy. Secondary outcomes include clinician's diagnostic confidence and routine clinical outcome measures. Cost-effective analysis will be conducted, alongside a qualitative assessment of the feasibility and acceptability of incorporating QbTest in routine practice. The findings from the study will inform commissioners, clinicians and managers about the feasibility, acceptability, clinical utility and cost-effectiveness of incorporating QbTest into routine diagnostic assessment of young people with ADHD. The results will be submitted for publication in peer-reviewed journals. The study has received ethical approval. NCT02209116. 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.

Improving correctional healthcare providers’ ability to care for transgender patients: Development and evaluation of a theory-driven cultural and clinical competence intervention

PubMed Central

White Hughto, Jaclyn M.; Clark, Kirsty A.; Altice, Frederick L.; Reisner, Sari L.; Kershaw, Trace S.; Pachankis, John E.

2017-01-01

Rationale Correctional healthcare providers’ limited cultural and clinical competence to care for transgender patients represents a barrier to care for incarcerated transgender individuals. Objective The present study aimed to adapt, deliver, and evaluate a transgender cultural and clinical competence intervention for correctional healthcare providers. Method In the summer of 2016, a theoretically-informed, group-based intervention to improve transgender cultural and clinical competence was delivered to 34 correctional healthcare providers in New England. A confidential survey assessed providers’ cultural and clinical competence to care for transgender patients, selfefficacy to provide hormone therapy, subjective norms related to transgender care, and willingness to provide gender-affirming care to transgender patients before and after (immediately and 3-months) the intervention. Linear mixed effects regression models were fit to assess change in study outcomes over time. Qualitative exit interviews assessed feasibility and acceptability of the intervention. Results Providers’ willingness to provide gender-affirming care improved immediately post-intervention (β = 0.38; SE = 0.41, p < 0.001) and from baseline to 3-months post-intervention (β = 0.36; SE = 0.09; p < 0.001; omnibus test of fixed effects χ2 = 23.21; p < 0.001). On average, transgender cultural competence (χ2 = 22.49; p < 0.001), medical gender affirmation knowledge (χ2 = 11.24; p = 0.01), self-efficacy to initiate hormones for transgender women, and subjective norms related to transgender care (χ2 = 14.69; p = 0.001) all significantly increased over time. Providers found the intervention to be highly acceptable and recommended that the training be scaled-up to other correctional healthcare providers and expanded to custody staff. Conclusion The intervention increased correctional healthcare providers’ cultural and clinical competence, selfefficacy, subjective norms, and willingness to provide gender-affirming care to transgender patients. Continued efforts should be made to train correctional healthcare providers in culturally and clinically competent gender-affirming care in order to improve the health of incarcerated transgender people. Future efficacy testing of this intervention is warranted. PMID:29096945

A Feminine Care Clinical Research Program Transforms Women’s Lives

PubMed Central

Tzeghai, Ghebre E.; Ajayi, Funmilayo O.; Miller, Kenneth W.; Imbescheid, Frank; Sobel, Jack D.; Farage, Miranda A.

2015-01-01

Feminine hygiene products and menstruation education have transformed the lives of women throughout the world. The P&G Feminine Care Clinical Innovation Research Program has played a key role by expanding scientific knowledge as well as developing technical insights and tools for the development of feminine hygiene products. The aim has been to meet the needs of women throughout their life stages, advancing their urogenital health beyond just menstruation, as well as helping to understand the role of sex hormones in various important health issues that women face. This review article highlights key contributions and research findings in female hygiene products, urogenital health research, and method development. The clinical research team focused on utilizing the results of clinical safety studies to advance the acceptance of feminine hygiene products world-wide. Key findings include that perception of skin sensitivity is not limited to the facial area, but is also relevant to the body and the genital area. Also, they shed light on the role of estrogen in autoimmune diseases as well as premenstrual syndrome. Efforts in the method development area focused on innovative tools that are reliable, predictive of clinical trial results and capable of measuring wear comfort, genital skin health, and the impact of product use on the consumer’s quality of life. A novel method, behind-the-knee (BTK) test, developed to model irritation under normal wear conditions, was the first to account for both chemical and mechanical sources of irritation. The method has been accepted by the FDA as a substitute in clinical trials in some cases, and by American Society for Testing and Materials as a global standard test method. Additional proprietary methods were developed to enhance visual grading of irritation using cross-polarized light, to measure the amount of lotion transferred from sanitary pads, and to evaluate the skin mildness. Finally, the Farage Quality of Life tool was created to measure consumer’s well-being. Based on the results of this extensive clinical research and the newly developed testing methods, the changing needs of women throughout their life stages are better met. PMID:25946910

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

Framing Innovation: Does an Instructional Vision Help Superintendents Gain Acceptance for a Large-Scale Technology Initiative?

ERIC Educational Resources Information Center

Flanagan, Gina E.

2014-01-01

There is limited research that outlines how a superintendent's instructional vision can help to gain acceptance of a large-scale technology initiative. This study explored how superintendents gain acceptance for a large-scale technology initiative (specifically a 1:1 device program) through various leadership actions. The role of the instructional…

Tablet Personal Computer Integration in Higher Education: Applying the Unified Theory of Acceptance and Use Technology Model to Understand Supporting Factors

ERIC Educational Resources Information Center

Moran, Mark; Hawkes, Mark; El Gayar, Omar

2010-01-01

Many educational institutions have implemented ubiquitous or required laptop, notebook, or tablet personal computing programs for their students. Yet, limited evidence exists to validate integration and acceptance of the technology among student populations. This research examines student acceptance of mobile computing devices using a modification…

The Future of Clinical Education: Using the Delphi Technique to Study Allied Health Deans' Perspectives on Definitions and Goals.

PubMed

Romig, Barbara D; Tucker, Ann W; Hewitt, Anne M; O'Sullivan Maillet, Julie

2016-01-01

Allied health (AH) clinical education provides future health professionals with the experiences necessary to develop the healthcare competencies required for success in their individual fields. There is limited information and consensus on the purposes of clinical education, including its definition and goals, and its comprehensive role in AH clinical training. This study explored whether consensus could be achieved in the definition, goals, and factors impacting AH clinical education. An expert panel consisting of 61 AH deans (54.9% of the population) whose institutions were 2013 members of the Association of Schools of Allied Health Professions (ASAHP) participated in a three-round Delphi study. From July 2013 to March 2014, the deans expressed opinions about clinical education and its purposes. Responses were collected, summarized, and refined, and responses were accepted and re-rated until agreement was achieved or the study concluded. The hypothesis that AH deans would agree upon the definition and goals of clinical education was supported by this study's findings. Over 90% of deans "strongly agreed" or "agreed" on the definition of clinical education. A majority (90.2% to 92.7%) agreed with the goals. High agreement was achieved on the purposes of clinical education, resulting in a comprehensive definition of and goals for AH clinical education. The definition and goals of clinical education can be added in the healthcare literature and used in support of AH education.

Kangaroo mother care: using formative research to design an acceptable community intervention.

PubMed

Mazumder, Sarmila; Upadhyay, Ravi Prakash; Hill, Zelee; Taneja, Sunita; Dube, Brinda; Kaur, Jasmine; Shekhar, Medha; Ghosh, Runa; Bisht, Shruti; Martines, Jose Carlos; Bahl, Rajiv; Sommerfelt, Halvor; Bhandari, Nita

2018-03-02

Low and middle income countries (LMICs), including India, contribute to a major proportion of low birth weight (LBW) infants globally. These infants require special care. Kangaroo Mother Care (KMC) in hospitals is a cost effective and efficacious intervention. In institutional deliveries, the duration of facility stay is often short. In LMICs, a substantial proportion of deliveries still occur at home and access to health care services is limited. In these circumstances, a pragmatic choice may be to initiate KMC at home for LBW babies. However, evidence is lacking on benefits of community-initiated KMC (cKMC). Promoting KMC at home without an understanding of its acceptability may lead to limited success. We conducted formative research to assess the feasibility, acceptability and adoption of cKMC with the aim of designing an intervention package for a randomised controlled trial in LBW infants in Haryana, India. Qualitative methods included 40 in-depth interviews with recently delivered women and 6 focus group discussions, two each with fathers and grandfathers, grandmothers, and community health workers. A prototype intervention package to promote cKMC was developed and tested in 28 mother-infant pairs (of them, one mother had twins), using Household (HH) trials. We found that most mothers in the community recognized that babies born small required special care. In spite of not being aware of the practice of KMC, respondents felt that creating awareness of KMC benefits will promote practice. They expressed concerns about doing KMC for long periods because mothers needed rest after delivery. However, the cultural practice of recently delivered women not expected to be doing household chores and availability of other family members were identified as enablers. HH trials provided an opportunity to test the intervention package and showed high acceptability for KMC. Most mothers perceived benefits such as weight gain and increased activity in the infant. Community-initiated KMC is acceptable by mothers and adoption rates are high. Formative research is essential for developing a strategy for delivery of an intervention. Trial registration number CTRI/2015/10/006267 . Name of Registry: Clinical Trials Registry - India. URL of Registry: http://ctri.nic.in/Clinicaltrials/login.php Date of Registration: 15/10/2015. Date of enrolment of the first participant to the trial: 18/04/2015.

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.

Meaning of living with severe chronic obstructive lung disease: a qualitative study.

PubMed

Marx, Gabriella; Nasse, Maximilian; Stanze, Henrikje; Boakye, Sonja Owusu; Nauck, Friedemann; Schneider, Nils

2016-12-08

To explore what it means for patients to live with chronic obstructive pulmonary disease (COPD) as an incurable and constantly progressing disease. Qualitative longitudinal study using narrative and semistructured interviews. This paper presents findings of the initial interviews. Analysis using grounded theory. Lung care clinics and community care in Lower Saxony, Germany. 17 patients with advanced-stage COPD (Global Initiative for Chronic Obstructive Lung Disease (GOLD) III/IV). Analysis shows that these patients have difficulties accepting their life situation and feel at the mercy of the disease, which could be identified as a core-experienced phenomenon. Over a long period of time, patients have only a vague feeling of being ill, caused by uncertain knowledge, slow progress and doubtful attribution of clinical symptoms of the disease (causal conditions). As an action strategy, patients try to maintain daily routines for as long as possible after diagnosis. Both effective standard and rescue medication, which helps to reduce breathlessness and other symptoms, and the feeling of being faced with one's own responsibility (intervening conditions) support this strategy, whereby patients' own responsibility is too painful to acknowledge. As a consequence, patients try to deny the threat to life for a long period of time. Frequently, they need to experience facing their own limits, often in the form of an acute crisis, to realise their health situation. The experience of the illness is contextualised by a continuous increase in limited mobility and social isolation. In order to help patients to improve disease awareness, to accept their life situation and to improve their reduced quality of life, patients may benefit from the early integration of palliative care (PC), considering its multiprofessional patient-centred and team-centred approach. Psychological support and volunteer work, which are relevant aspects of PC, should be appropriate to address psychosocial needs. More research is needed to evaluate how patients could benefit from early PC. 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/.

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.

Phase II evaluation of clinical coding schemes: completeness, taxonomy, mapping, definitions, and clarity. CPRI Work Group on Codes and Structures.

PubMed

Campbell, J R; Carpenter, P; Sneiderman, C; Cohn, S; Chute, C G; Warren, J

1997-01-01

To compare three potential sources of controlled clinical terminology (READ codes version 3.1, SNOMED International, and Unified Medical Language System (UMLS) version 1.6) relative to attributes of completeness, clinical taxonomy, administrative mapping, term definitions and clarity (duplicate coding rate). The authors assembled 1929 source concept records from a variety of clinical information taken from four medical centers across the United States. The source data included medical as well as ample nursing terminology. The source records were coded in each scheme by an investigator and checked by the coding scheme owner. The codings were then scored by an independent panel of clinicians for acceptability. Codes were checked for definitions provided with the scheme. Codes for a random sample of source records were analyzed by an investigator for "parent" and "child" codes within the scheme. Parent and child pairs were scored by an independent panel of medical informatics specialists for clinical acceptability. Administrative and billing code mapping from the published scheme were reviewed for all coded records and analyzed by independent reviewers for accuracy. The investigator for each scheme exhaustively searched a sample of coded records for duplications. SNOMED was judged to be significantly more complete in coding the source material than the other schemes (SNOMED* 70%; READ 57%; UMLS 50%; *p < .00001). SNOMED also had a richer clinical taxonomy judged by the number of acceptable first-degree relatives per coded concept (SNOMED* 4.56, UMLS 3.17; READ 2.14, *p < .005). Only the UMLS provided any definitions; these were found for 49% of records which had a coding assignment. READ and UMLS had better administrative mappings (composite score: READ* 40.6%; UMLS* 36.1%; SNOMED 20.7%, *p < .00001), and SNOMED had substantially more duplications of coding assignments (duplication rate: READ 0%; UMLS 4.2%; SNOMED* 13.9%, *p < .004) associated with a loss of clarity. No major terminology source can lay claim to being the ideal resource for a computer-based patient record. However, based upon this analysis of releases for April 1995, SNOMED International is considerably more complete, has a compositional nature and a richer taxonomy. Is suffers from less clarity, resulting from a lack of syntax and evolutionary changes in its coding scheme. READ has greater clarity and better mapping to administrative schemes (ICD-10 and OPCS-4), is rapidly changing and is less complete. UMLS is a rich lexical resource, with mappings to many source vocabularies. It provides definitions for many of its terms. However, due to the varying granularities and purposes of its source schemes, it has limitations for representation of clinical concepts within a computer-based patient record.

Phase II Evaluation of Clinical Coding Schemes

PubMed Central

Campbell, James R.; Carpenter, Paul; Sneiderman, Charles; Cohn, Simon; Chute, Christopher G.; Warren, Judith

1997-01-01

Abstract Objective: To compare three potential sources of controlled clinical terminology (READ codes version 3.1, SNOMED International, and Unified Medical Language System (UMLS) version 1.6) relative to attributes of completeness, clinical taxonomy, administrative mapping, term definitions and clarity (duplicate coding rate). Methods: The authors assembled 1929 source concept records from a variety of clinical information taken from four medical centers across the United States. The source data included medical as well as ample nursing terminology. The source records were coded in each scheme by an investigator and checked by the coding scheme owner. The codings were then scored by an independent panel of clinicians for acceptability. Codes were checked for definitions provided with the scheme. Codes for a random sample of source records were analyzed by an investigator for “parent” and “child” codes within the scheme. Parent and child pairs were scored by an independent panel of medical informatics specialists for clinical acceptability. Administrative and billing code mapping from the published scheme were reviewed for all coded records and analyzed by independent reviewers for accuracy. The investigator for each scheme exhaustively searched a sample of coded records for duplications. Results: SNOMED was judged to be significantly more complete in coding the source material than the other schemes (SNOMED* 70%; READ 57%; UMLS 50%; *p <.00001). SNOMED also had a richer clinical taxonomy judged by the number of acceptable first-degree relatives per coded concept (SNOMED* 4.56; UMLS 3.17; READ 2.14, *p <.005). Only the UMLS provided any definitions; these were found for 49% of records which had a coding assignment. READ and UMLS had better administrative mappings (composite score: READ* 40.6%; UMLS* 36.1%; SNOMED 20.7%, *p <. 00001), and SNOMED had substantially more duplications of coding assignments (duplication rate: READ 0%; UMLS 4.2%; SNOMED* 13.9%, *p <. 004) associated with a loss of clarity. Conclusion: No major terminology source can lay claim to being the ideal resource for a computer-based patient record. However, based upon this analysis of releases for April 1995, SNOMED International is considerably more complete, has a compositional nature and a richer taxonomy. It suffers from less clarity, resulting from a lack of syntax and evolutionary changes in its coding scheme. READ has greater clarity and better mapping to administrative schemes (ICD-10 and OPCS-4), is rapidly changing and is less complete. UMLS is a rich lexical resource, with mappings to many source vocabularies. It provides definitions for many of its terms. However, due to the varying granularities and purposes of its source schemes, it has limitations for representation of clinical concepts within a computer-based patient record. PMID:9147343

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.

Development and evaluation of a dietary self-management programme for older adults with low literacy and heart disease: pilot study of feasibility and acceptability.

PubMed

Shao, Jung-Hua; Chen, Su-Hui

2016-12-01

To develop a dietary self-management programme for salt-, fluid-, fat- and cholesterol-intake behaviours for older adults with low literacy and heart disease and evaluate the feasibility and acceptability of the programme. Eating behaviours such as fluid, salt, fat and cholesterol intake are an important factor related to heart disease outcomes. People with low literacy have difficulty following recommended health behaviours, but limited research has investigated intervention programmes for this population. Programme development and pilot testing its feasibility and acceptability. Recommendations were also collected from participants and the research assistant for future large-scale interventions. The study had two phases. Phase I consisted of programme development based on previous qualitative findings, a systematic review of the literature, clinical practice experience and expert opinion. In Phase II, we pilot tested the programme from January - June 2014 in a convenience sample of 10 older adults with low literacy, heart disease and recruited from a medical centre in northern Taiwan. Pilot testing showed that our programme was feasible and acceptable to older adults with low literacy and heart disease. Moreover, the final version of the programme was revised based on participants' and the research assistant's recommendations. Our study results suggest that with guidance and assistance, older adults with low literacy and heart disease can be motivated to take action for their health and are empowered by learning how to self-manage their heart-healthy eating behaviours. © 2016 John Wiley & Sons Ltd.

Building sustainable communities using sense of place indicators in three Hudson River Valley, NY, tourism destinations: An application of the limits of acceptable change process

Treesearch

Laura E. Sullivan; Rudy M. Schuster; Diane M. Kuehn; Cheryl S. Doble; Duarte Morais

2010-01-01

This study explores whether measures of residents' sense of place can act as indicators in the Limits of Acceptable Change (LAC) process to facilitate tourism planning and management. Data on community attributes valued by residents and the associated values and meanings were collected through focus groups with 27 residents in three Hudson River Valley, New York,...

Living with hypertrophic cardiomyopathy and an implantable defibrillator.

PubMed

Magnusson, Peter; Jonsson, Jessica; Mörner, Stellan; Fredriksson, Lennart

2017-05-10

ICDs efficiently terminate life-threatening arrhythmias, but complications occur during long-term follow-up. Patients' own perspective is largely unknown. The aim of the study was to describe experiences of hypertrophic cardiomyopathy (HCM) patients with implantable defibrillators (ICDs). We analyzed 26 Swedish patient interviews using hermeneutics and latent content analysis. Patients (aged 27-76 years) were limited by HCM especially if it deteriorates into heart failure. The ICD implies safety, gratitude, and is accepted as a part of the body even when inappropriate ICD shocks are encountered. Nobody regretted the implant. Both the disease and the ICD affected professional life and leisure time activities, especially at younger ages. Family support was usually strong, but sometimes resulted in overprotection, whereas health care focused on medical issues. Despite limitations, patients adapted, accepted, and managed challenges. HCM patients with ICDs reported good spirit and hope even though they had to adapt and accept limitations over time.

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.

Colour stability of temporary restorations with different thicknesses submitted to artificial accelerated aging.

PubMed

Silame, F D J; Tonani, R; Alandia-Roman, C C; Chinelatti, M; Panzeri, H; Pires-de-Souza, F C P

2013-12-01

This study evaluated the colour stability of temporary prosthetic restorations with different thicknesses submitted to artificial accelerated aging. The occlusal surfaces of 40 molars were grinded to obtain flat enamel surfaces. Twenty acrylic resin specimens [Polymethyl methacrylate (Duralay) and Bis-methyl acrylate (Luxatemp)] were made with two different thicknesses, 0.5 mm and 1.0 mm. Temporary restorations were fixed on enamel and CIE L*a*b* colour parameters of each specimen were assessed before and after artificial accelerated aging. All groups showed colour alterations above the clinically acceptable limit. Luxatemp showed the lowest colour alteration regardless its thickness and Duralay showed the greatest alteration with 0.5 mm.

Overdentures on natural teeth: a new approach.

PubMed

Previgliano, V; Barone Monfrin, S; Santià, G; Preti, G

2004-01-01

The study presents a new type of copings for overdentures on natural teeth. A new type of custom-made copings was prepared on 10 extracted teeth and their marginal fit was observed microscopically by means of a mechanical device, and software was employed to measure the gap. The marginal fit evaluation gave satisfactory values with mean values of the gap measurements below the clinically accepted limits (mean gap: 25.3 microm; minimum 7.3 microm, maximum 56.5 microm). The advantages of these new copings are: the rapidity of their preparation; the protection of the root canal treatment, because the coping with this chair-side method is prepared and cemented in one session; the low costs.

An evaluation of the ELT-8 hematology analyzer.

PubMed

Raik, E; McPherson, J; Barton, L; Hewitt, B S; Powell, E G; Gordon, S

1982-04-01

The TMELT-8 Hematology Analyzer is a fully automated cell counter which utilizes laser light scattering and hydrodynamic focusing to provide an 8 parameter whole blood count. The instrument consists of a sample handler with ticket printer, and a data handler with visual display unit, It accepts 100 microliter samples of venous or capillary blood and prints the values for WCC, RCC, Hb, Hct, MCV, MCH, MCHC and platelet count on to a standard result card. All operational and quality control functions, including graphic display of relative cell size distribution, can be obtained from the visual display unit and can also be printed as a permanent record if required. In a limited evaluation of the ELT-8, precision, linearity, accuracy, lack of sample carry-over and user acceptance were excellent. Reproducible values were obtained for all parameters after overnight storage of samples. Reagent usage and running costs were lower than for the Coulter S and the Coulter S Plus. The ease of processing capillary samples was considered to be a major advantage. The histograms served to alert the operator to a number of abnormalities, some of which were clinically significant.

Use of an interactive game to increase food acceptance--a pilot study.

PubMed

Gillis, L

2003-09-01

Techniques to improve food selection in healthy children with long standing food refusal are limited. The use of educational games has been successful in getting children to increase knowledge in healthy eating, but it is uncertain whether this translates into behaviour change. Therefore the purpose of this study was to test the use of an interactive food game to increase food acceptance in healthy-weight school-age children with chronic food refusal. Children attended an outpatient clinic and played an interactive game with a therapist and one parent during which non-preferred foods were consumed. Weekly recording of food consumption occurred with diet analysis by a Registered Dietitian three times during a 1-year time span. The children increased their repertoire of foods and had a more balanced intake. The changes in intake were incorporated into their daily meal patterns in the home setting and were maintained for 1 year. An interactive food game is a successful tool for increasing food variety in healthy children with chronic food refusal. As this report included only three subjects, the results will be used for subsequent work on this topic.

The role of simulation in mixed-methods research: a framework & application to patient safety.

PubMed

Guise, Jeanne-Marie; Hansen, Matthew; Lambert, William; O'Brien, Kerth

2017-05-04

Research in patient safety is an important area of health services research and is a national priority. It is challenging to investigate rare occurrences, explore potential causes, and account for the complex, dynamic context of healthcare - yet all are required in patient safety research. Simulation technologies have become widely accepted as education and clinical tools, but have yet to become a standard tool for research. We developed a framework for research that integrates accepted patient safety models with mixed-methods research approaches and describe the performance of the framework in a working example of a large National Institutes of Health (NIH)-funded R01 investigation. This worked example of a framework in action, identifies the strengths and limitations of qualitative and quantitative research approaches commonly used in health services research. Each approach builds essential layers of knowledge. We describe how the use of simulation ties these layers of knowledge together and adds new and unique dimensions of knowledge. A mixed-methods research approach that includes simulation provides a broad multi-dimensional approach to health services and patient safety research.

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.

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.

Participation of Colorado pediatricians and family physicians in the Medicaid program.

PubMed Central

Berman, S.; Wasserman, S.; Grimm, S.

1991-01-01

The Pediatric Health Policy Group of the University of Colorado Health Sciences Center (Denver) surveyed 650 family physicians and 296 pediatricians in 1988, with 50% of family physicians and 48% of pediatricians responding. Half of the pediatricians in private practice and 35% of family physicians in private practice accepted all children who were Medicaid beneficiaries into their practice; 42% of pediatricians and 50% of family physicians accepted all non-Medicaid patients but only some new Medicaid patients; and 8% of pediatricians and 15% of family physicians accepted new non-Medicaid patients but no Medicaid patients. Practice location was associated with the level of Medicaid participation for these primary care physicians: Significantly more rural pediatricians and family physicians than those with urban practices accepted Medicaid patients. The average reimbursement level for these physicians was shown to be an important determinant of whether physicians would accept Medicaid patients. Nonparticipatory physicians were more concerned about excessive paperwork compared with physicians with limited participation. Among physicians with limited participation, family physicians and pediatricians both cited problems of excessive paperwork, reimbursement delays, and retroactive denials of payment as important deterrents to accepting Medicaid patients. PMID:1812643

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.

Counselor attitudes toward contingency management for substance use disorder: effectiveness, acceptability, and endorsement of incentives for treatment attendance and abstinence☆

PubMed Central

Aletraris, Lydia; Shelton, Jeff S.; Roman, Paul M.

2015-01-01

Despite research demonstrating its effectiveness, use of contingency management (CM) in substance use disorder treatment has been limited. Given the vital role that counselors play as arbiters in the use of therapies, examination of their attitudes can provide insight into how further use of CM might be effectively promoted. In this paper, we examine 731 counselors' attitudes toward the effectiveness and acceptability of CM in treatment, as well as their specific attitudes toward both unspecified and tangible incentives for treatment attendance and abstinence. Compared to cognitive behavioral therapy, motivational interviewing, and community reinforcement approach, counselors rated CM as the least effective and least acceptable psychosocial intervention. Exposure through the use of CM in a counselor's employing organization was positively associated with perceptions of acceptability, agreement that incentives have a positive effect on the client–counselor relationship, and endorsement of tangible incentives for abstinence. Endorsement of tangible incentives for treatment attendance was significantly greater among counselors with more years in the treatment field, and counselors who held at least a master's degree. Counselors' adaptability or openness to innovations was also positively associated with attitudes toward CM. Further, female counselors and counsellors with a greater 12-step philosophy were less likely to endorse the use of incentives. A highlight of our study is that it offers the first specific assessment of the impact of “Promoting Awareness of Motivational Incentives” (PAMI), a Web-based tool based on findings of CM protocols tested within the Clinical Trials Network (CTN), on counselors employed outside the CTN. We found that 10% of counselors had accessed PAMI, and those who had accessed PAMI were more likely to report a higher degree of perceived effectiveness of CM than those who had not. This study lays the groundwork for vital research on the impact of multiple Web-based educational strategies. Given the barriers to CM adoption, identifying predictors of positive attitudes among counselors can help diffuse CM into routine clinical practice. PMID:26001821

The safety and efficacy of using a concentrated intranasal midazolam formulation for paediatric dental sedation.

PubMed

Wood, Michael

2011-01-01

To add to the evidence base for safe and effective paediatric conscious sedation techniques in primary dental care. To consider the safety and effectiveness of an alternative sedation technique for facilitating dental treatment in anxious children, thereby avoiding dental general anaesthetic. Leagrave Dental Sedation Clinic. A primary care-based general and referral clinic for anxious patients, special care dentistry and oral surgery. This is a prospective service evaluation of 114 selected anxious children requiring invasive dental treatment. Each child was administered 0.25 mg/kg intranasal midazolam using a concentrated 40 mg/ml midazolam (INM) in 2% lignocaine solution. Successful completion of intended dental treatment with a child who is co-operative and who meets the UK accepted definition of conscious sedation. 57% of the children found the administration of the new formulation acceptable. Of the 114 patients who received INM, 104 completed the treatment (91%). The 10 children who could not complete the treatment with INM were converted to intravenous sedation and treatment was completed successfully at the same appointment. During treatment there was no desaturation and only one patient desaturated briefly in the recovery area. Parents rated the technique acceptable in 76% of cases and would have the procedure repeated in 83% of cases. Parents rated this technique as having 8.3 out of 10 with only 5 parents awarding a score of less than 7 out of 10. Side effects included blurred vision, sneezing, headaches, restlessness with one patient having post-operative nausea and vomiting. In selected cases intranasal sedation provides a safe and effective alternative for dental GA in short invasive procedures limited to one or two quadrants in children. Other techniques, e.g., oral and intravenous sedation, appear to have a much higher acceptability of administration. This technique may be useful if inhalation sedation, oral sedation or intravenous sedation is considered and the child is still unco-operative, either as a technique on its own or to facilitate cannulation for intravenous sedation. It is recommended that this technique should only be used by dentists skilled in intravenous paediatric sedation with midazolam with the appropriate staff training and equipment at their disposal.

Professional medical writing support and the quality of randomised controlled trial reporting: a cross-sectional study.

PubMed

Gattrell, William T; Hopewell, Sally; Young, Kate; Farrow, Paul; White, Richard; Wager, Elizabeth; Winchester, Christopher C

2016-02-21

Authors may choose to work with professional medical writers when writing up their research for publication. We examined the relationship between medical writing support and the quality and timeliness of reporting of the results of randomised controlled trials (RCTs). Cross-sectional study. Primary reports of RCTs published in BioMed Central journals from 2000 to 16 July 2014, subdivided into those with medical writing support (n=110) and those without medical writing support (n=123). Proportion of items that were completely reported from a predefined subset of the Consolidated Standards of Reporting Trials (CONSORT) checklist (12 items known to be commonly poorly reported), overall acceptance time (from manuscript submission to editorial acceptance) and quality of written English as assessed by peer reviewers. The effect of funding source and publication year was examined. The number of articles that completely reported at least 50% of the CONSORT items assessed was higher for those with declared medical writing support (39.1% (43/110 articles); 95% CI 29.9% to 48.9%) than for those without (21.1% (26/123 articles); 95% CI 14.3% to 29.4%). Articles with declared medical writing support were more likely than articles without such support to have acceptable written English (81.1% (43/53 articles); 95% CI 67.6% to 90.1% vs 47.9% (23/48 articles); 95% CI 33.5% to 62.7%). The median time of overall acceptance was longer for articles with declared medical writing support than for those without (167 days (IQR 114.5-231 days) vs 136 days (IQR 77-193 days)). In this sample of open-access journals, declared professional medical writing support was associated with more complete reporting of clinical trial results and higher quality of written English. Medical writing support may play an important role in raising the quality of clinical trial reporting. 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/

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.

Reproductive medicine involving genome editing: clinical uncertainties and embryological needs.

PubMed

Ishii, Tetsuya

2017-01-01

Genome editing based on site-directed nucleases facilitated efficient and versatile genetic modifications in human cells. However, recent reports, demonstrating CRISPR/Cas9-mediated genome editing in human embryos have raised profound concerns worldwide. This commentary explores the clinical justification and feasibility of reproductive medicine using germline genome editing. Despite the perceived utility of reproductive medicine for treating intractable infertility, it is difficult to justify germline genome editing from the perspective of the prospective child. As suggested by the UK legalization regarding mitochondrial donation, the prevention of genetic disease in offspring by genome editing might be acceptable in limited cases of serious or life-threatening conditions, where no alternative medicine is available. Nonetheless, the mosaicism underlying human embryos as well as the off-target effect by artificial nucleases will likely hamper preimplantation genetic diagnosis prior to embryo transfer. Such considerations suggest that this type of reproductive medicine should not be developed toward a clinical application. However, the clinical uncertainties underscore the need for embryology that can address fundamental questions regarding germline aneuploidy and mosaicism using genome editing. Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Diabetes mellitus in neonates and infants: genetic heterogeneity, clinical approach to diagnosis, and therapeutic options.

PubMed

Rubio-Cabezas, Oscar; Ellard, Sian

2013-01-01

Over the last decade, we have witnessed major advances in the understanding of the molecular basis of neonatal and infancy-onset diabetes. It is now widely accepted that diabetes presenting before 6 months of age is unlikely to be autoimmune type 1 diabetes. The vast majority of such patients will have a monogenic disorder responsible for the disease and, in some of them, also for a number of other associated extrapancreatic clinical features. Reaching a molecular diagnosis will have immediate clinical consequences for about half of affected patients, as identification of a mutation in either of the two genes encoding the ATP-sensitive potassium channel allows switching from insulin injections to oral sulphonylureas. It also facilitates genetic counselling within the affected families and predicts clinical prognosis. Importantly, monogenic diabetes seems not to be limited to the first 6 months but extends to some extent into the second half of the first year of life, when type 1 diabetes is the more common cause of diabetes. From a scientific perspective, the identification of novel genetic aetiologies has provided important new knowledge regarding the development and function of the human pancreas. Copyright © 2013 S. Karger AG, Basel.

Diabetes Mellitus in Neonates and Infants: Genetic Heterogeneity, Clinical Approach to Diagnosis, and Therapeutic Options

PubMed Central

Rubio-Cabezas, Oscar; Ellard, Sian

2013-01-01

Over the last decade, we have witnessed major advances in the understanding of the molecular basis of neonatal and infancy-onset diabetes. It is now widely accepted that diabetes presenting before 6 months of age is unlikely to be autoimmune type 1 diabetes. The vast majority of such patients will have a monogenic disorder responsible for the disease and, in some of them, also for a number of other associated extrapancreatic clinical features. Reaching a molecular diagnosis will have immediate clinical consequences for about half of affected patients, as identification of a mutation in either of the two genes encoding the ATP-sensitive potassium channel allows switching from insulin injections to oral sulphonylureas. It also facilitates genetic counselling within the affected families and predicts clinical prognosis. Importantly, monogenic diabetes seems not to be limited to the first 6 months but extends to some extent into the second half of the first year of life, when type 1 diabetes is the more common cause of diabetes. From a scientific perspective, the identification of novel genetic aetiologies has provided important new knowledge regarding the development and function of the human pancreas. PMID:24051999

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.

40 CFR 227.27 - Limiting permissible con-cen-tra-tion (LPC).

Code of Federal Regulations, 2014 CFR

2014-07-01

... scientific literature or accepted by EPA as being reliable test organisms to determine the anticipated impact... for each type they represent, and that are documented in the scientific literature and accepted by EPA...

40 CFR 227.27 - Limiting permissible con-cen-tra-tion (LPC).

Code of Federal Regulations, 2013 CFR

2013-07-01

... scientific literature or accepted by EPA as being reliable test organisms to determine the anticipated impact... for each type they represent, and that are documented in the scientific literature and accepted by EPA...

Shelf-life modeling of bakery products by using oxidation indices.

PubMed

Calligaris, Sonia; Manzocco, Lara; Kravina, Giuditta; Nicoli, Maria Cristina

2007-03-07

The aim of this work was to develop a shelf-life prediction model of lipid-containing bakery products. To this purpose (i) the temperature dependence of the oxidation rate of bakery products was modeled, taking into account the changes in lipid physical state; (ii) the acceptance limits were assessed by sensory analysis; and (iii) the relationship between chemical oxidation index and acceptance limit was evaluated. Results highlight that the peroxide number, the changes of which are linearly related to consumer acceptability, is a representative index of the quality depletion of biscuits during their shelf life. In addition, the evolution of peroxides can be predicted by a modified Arrhenius equation accounting for the changes in the physical state of biscuit fat. Knowledge of the relationship between peroxides and sensory acceptability together with the temperature dependence of peroxide formation allows a mathematical model to be set up to simply and quickly calculate the shelf life of biscuits.

Vibration safety limits for magnetic resonance elastography.

PubMed

Ehman, E C; Rossman, P J; Kruse, S A; Sahakian, A V; Glaser, K J

2008-02-21

Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within a tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit, and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans.

Vibration safety limits for magnetic resonance elastography

PubMed Central

Ehman, E C; Rossman, P J; Kruse, S A; Sahakian, A V; Glaser, K J

2010-01-01

Magnetic resonance elastography (MRE) has been demonstrated to have potential as a clinical tool for assessing the stiffness of tissue in vivo. An essential step in MRE is the generation of acoustic mechanical waves within tissue via a coupled mechanical driver. Motivated by an increasing volume of human imaging trials using MRE, the objectives of this study were to audit the vibration amplitude of exposure for our IRB-approved human MRE studies, to compare these values to a conservative regulatory standard for vibrational exposure, and to evaluate the applicability and implications of this standard for MRE. MRE displacement data were examined from 29 MRE exams, including the liver, brain, kidney, breast, and skeletal muscle. Vibrational acceleration limits from a European Union directive limiting occupational exposure to whole-body and extremity vibrations (EU 2002/44/EC) were adjusted for time and frequency of exposure, converted to maximum displacement values, and compared to the measured in vivo displacements. The results indicate that the vibrational amplitudes used in MRE studies are below the EU whole-body vibration limit and the EU guidelines represent a useful standard that could be readily accepted by Institutional Review Boards to define standards for vibrational exposures for MRE studies in humans. PMID:18263949

Pre-analytical and analytical aspects affecting clinical reliability of plasma glucose results.

PubMed

Pasqualetti, Sara; Braga, Federica; Panteghini, Mauro

2017-07-01

The measurement of plasma glucose (PG) plays a central role in recognizing disturbances in carbohydrate metabolism, with established decision limits that are globally accepted. This requires that PG results are reliable and unequivocally valid no matter where they are obtained. To control the pre-analytical variability of PG and prevent in vitro glycolysis, the use of citrate as rapidly effective glycolysis inhibitor has been proposed. However, the commercial availability of several tubes with studies showing different performance has created confusion among users. Moreover, and more importantly, studies have shown that tubes promptly inhibiting glycolysis give PG results that are significantly higher than tubes containing sodium fluoride only, used in the majority of studies generating the current PG cut-points, with a different clinical classification of subjects. From the analytical point of view, to be equivalent among different measuring systems, PG results should be traceable to a recognized higher-order reference via the implementation of an unbroken metrological hierarchy. In doing this, it is important that manufacturers of measuring systems consider the uncertainty accumulated through the different steps of the selected traceability chain. In particular, PG results should fulfil analytical performance specifications defined to fit the intended clinical application. Since PG has tight homeostatic control, its biological variability may be used to define these limits. Alternatively, given the central diagnostic role of the analyte, an outcome model showing the impact of analytical performance of test on clinical classifications of subjects can be used. Using these specifications, performance assessment studies employing commutable control materials with values assigned by reference procedure have shown that the quality of PG measurements is often far from desirable and that problems are exacerbated using point-of-care devices. Copyright © 2017 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

Atomic spectrometry and trends in clinical laboratory medicine

NASA Astrophysics Data System (ADS)

Parsons, Patrick J.; Barbosa, Fernando

2007-09-01

Increasing numbers of clinical laboratories are transitioning away from flame and electrothermal AAS methods to those based on ICP-MS. Still, for many laboratories, the choice of instrumentation is based upon (a) the element(s) to be determined, (b) the matrix/matrices to be analyzed, and (c) the expected concentration(s) of the analytes in the matrix. Most clinical laboratories specialize in measuring Se, Zn, Cu, and Al in serum, and/or Pb, Cd, Hg, As, and Cr in blood and/or urine, while other trace elements (e.g., Pt, Au etc.) are measured for therapeutic purposes. Quantitative measurement of elemental species is becoming more widely accepted for nutritional and/or toxicological screening purposes, and ICP-MS interfaced with separation techniques, such as liquid chromatography or capillary electrophoresis, offers the advantage of on-line species determination coupled with very low detection limits. Polyatomic interferences for some key elements such as Se, As, and Cr require instrumentation equipped with dynamic reaction cell or collision cell technologies, or might even necessitate the use of sector field ICP-MS, to assure accurate results. Nonetheless, whatever analytical method is selected for the task, careful consideration must be given both to specimen collection procedures and to the control of pre-analytical variables. Finally, all methods benefit from access to reliable certified reference materials (CRMs). While a variety of reference materials (RMs) are available for trace element measurements in clinical matrices, not all can be classified as CRMs. The major metrological organizations (e.g., NIST, IRMM, NIES) provide a limited number of clinical CRMs, however, secondary reference materials are readily available from commercial organizations and organizers of external quality assessment schemes.