Promoting student case creation to enhance instruction of clinical reasoning skills: a pilot feasibility study

PubMed Central

Chandrasekar, Hamsika; Gesundheit, Neil; Nevins, Andrew B; Pompei, Peter; Bruce, Janine; Merrell, Sylvia Bereknyei

2018-01-01

Background It is a common educational practice for medical students to engage in case-based learning (CBL) exercises by working through clinical cases that have been developed by faculty. While such faculty-developed exercises have educational strengths, there are at least two major drawbacks to learning by this method: the number and diversity of cases is often limited; and students decrease their engagement with CBL cases as they grow accustomed to the teaching method. We sought to explore whether student case creation can address both of these limitations. We also compared student case creation to traditional clinical reasoning sessions in regard to tutorial group effectiveness, perceived gains in clinical reasoning, and quality of student–faculty interaction. Methods Ten first-year medical students participated in a feasibility study wherein they worked in small groups to develop their own patient case around a preassigned diagnosis. Faculty provided feedback on case quality afterwards. Students completed pre- and post-self-assessment surveys. Students and faculty also participated in separate focus groups to compare their case creation experience to traditional CBL sessions. Results Students reported high levels of team engagement and peer learning, as well as increased ownership over case content and understanding of clinical reasoning nuances. However, students also reported decreases in student–faculty interaction and the use of visual aids (P < 0.05). Conclusion The results of our feasibility study suggest that student-generated cases can be a valuable adjunct to traditional clinical reasoning instruction by increasing content ownership, encouraging student-directed learning, and providing opportunities to explore clinical nuances. However, these gains may reduce student–faculty interaction. Future studies may be able to identify an improved model of faculty participation, the ideal timing for incorporation of this method in a medical curriculum, and a more rigorous assessment of the impact of student case creation on the development of clinical reasoning skills. PMID:29692641

Knee ultrasound from research to real practice: a systematic literature review of adult knee ultrasound assessment feasibility studies.

PubMed

Peltea, Alexandra; Berghea, Florian; Gudu, Tania; Ionescu, Ruxandra

2016-12-05

To identify and analyse existing data regarding knee ultrasound (US) feasibility in clinical practice. Material and methods: A systematic literature review was performed using the terms: ("knee") AND ("ultrasound" OR "ultrasonography") AND ("feasibility" OR "pilot" OR "proof of concept"). Feasibility studies regarding knee US or US aided maneuver involving knee joint, published during 2005-2015, were selected and evaluated against a complex framework constructed around mandatory key areas for feasibility studies: acceptability, demand, implementation, practicality, adaptation, integration and expansion. One hundred and fifty-nine publications were identified, of which 9 were included in the final analysis: 6 dealt with the development and implementation of novel US scores, while the rest focused on implementing MSUS in clinical practice, evaluating the usefulness of articular cartilage US assessment and the feasibility of sonography for intra-articular knee injections, respectively. Six studies quantified feasibility as time spent for the evaluation, with only two addressing areassuch as acceptability, implementation and practicality, although none of these systematically assessed all feasibility domains. Knee US feasibility is still poorly addressed; the time required for US assessment is the main area addressed. This information gap should be properly addressed in future works, in order to ensure the right place for this technique.

A modern optical character recognition system in a real world clinical setting: some accuracy and feasibility observations.

PubMed Central

Biondich, Paul G.; Overhage, J. Marc; Dexter, Paul R.; Downs, Stephen M.; Lemmon, Larry; McDonald, Clement J.

2002-01-01

Advances in optical character recognition (OCR) software and computer hardware have stimulated a reevaluation of the technology and its ability to capture structured clinical data from preexisting paper forms. In our pilot evaluation, we measured the accuracy and feasibility of capturing vitals data from a pediatric encounter form that has been in use for over twenty years. We found that the software had a digit recognition rate of 92.4% (95% confidence interval: 91.6 to 93.2) overall. More importantly, this system was approximately three times as fast as our existing method of data entry. These preliminary results suggest that with further refinements in the approach and additional development, we may be able to incorporate OCR as another method for capturing structured clinical data. PMID:12463786

SU-F-J-06: Optimized Patient Inclusion for NaF PET Response-Based Biopsies

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

Roth, A; Harmon, S; Perk, T

Purpose: A method to guide mid-treatment biopsies using quantitative [F-18]NaF PET/CT response is being investigated in a clinical trial. This study aims to develop methodology to identify patients amenable to mid-treatment biopsy based on pre-treatment imaging characteristics. Methods: 35 metastatic prostate cancer patients had NaF PET/CT scans taken prior to the start of treatment and 9–12 weeks into treatment. For mid-treatment biopsy targeting, lesions must be at least 1.5 cm{sup 3} and located in a clinically feasible region (lumbar/sacral spine, pelvis, humerus, or femur). Three methods were developed based on number of lesions present prior to treatment: a feasibility-restricted method,more » a location-restricted method, and an unrestricted method. The feasibility restricted method only utilizes information from lesions meeting biopsy requirements in the pre-treatment scan. The unrestricted method accounts for all lesions present in the pre-treatment scan. For each method, optimized classification cutoffs for candidate patients were determined. Results: 13 of the 35 patients had enough lesions at the mid-treatment for biopsy candidacy. Of 1749 lesions identified in all 35 patients at mid-treatment, only 9.8% were amenable to biopsy. Optimizing the feasibility-restricted method required 4 lesions at pre-treatment meeting volume and region requirements for biopsy, resulting patient identification sensitivity of 0.8 and specificity of 0.7. Of 6 false positive patients, only one patient lacked lesions for biopsy. Restricting for location alone showed poor results (sensitivity 0.2 and specificity 0.3). The optimized unrestricted method required patients have at least 37 lesions in pretreatment scan, resulting in a sensitivity of 0.8 and specificity of 0.8. There were 5 false positives, only one lacked lesions for biopsy. Conclusion: Incorporating the overall pre-treatment number of NaF PET/CT identified lesions provided best prediction for identifying candidate patients for mid-treatment biopsy. This study provides validity for prediction-based inclusion criteria that can be extended to various clinical trial scenarios. Funded by Prostate Cancer Foundation.« less

New Clinically Feasible 3T MRI Protocol to Discriminate Internal Brain Stem Anatomy.

PubMed

Hoch, M J; Chung, S; Ben-Eliezer, N; Bruno, M T; Fatterpekar, G M; Shepherd, T M

2016-06-01

Two new 3T MR imaging contrast methods, track density imaging and echo modulation curve T2 mapping, were combined with simultaneous multisection acquisition to reveal exquisite anatomic detail at 7 canonical levels of the brain stem. Compared with conventional MR imaging contrasts, many individual brain stem tracts and nuclear groups were directly visualized for the first time at 3T. This new approach is clinically practical and feasible (total scan time = 20 minutes), allowing better brain stem anatomic localization and characterization. © 2016 by American Journal of Neuroradiology.

'Personalised evidence' for personalised healthcare: integration of a clinical librarian into mental health services - a feasibility study.

PubMed

Steele, Rachel; Tiffin, Paul A

2014-02-01

Aims and method To evaluate the feasibility of integrating a clinical librarian (CL) within four mental health teams. A CL was attached to three clinical teams and the Trustwide Psychology Research and Clinical Governance Structure for 12 months. Requests for evidence syntheses were recorded. The perceived impact of individual evidence summaries on staff activities was evaluated using a brief online questionnaire. Results Overall, 82 requests for evidence summaries were received: 50% related to evidence for individual patient care, 23% to generic clinical issues and 27% were on management/corporate topics. In the questionnaires 105 participants indicated that the most common impact on their practice was advice given to colleagues (51 respondents), closely followed by the evidence summaries stimulating new ideas for patient care or treatment (50 respondents). Clinical implications The integration of a CL into clinical and corporate teams is feasible and perceived as having an impact on staff activities. A CL may be able to collate 'personalised evidence' which may enhance individualised healthcare. In some cases the usual concept of a hierarchy of evidence may not easily apply, with case reports providing guidance which may be more applicable than population-based studies.

‘Personalised evidence’ for personalised healthcare: integration of a clinical librarian into mental health services – a feasibility study

PubMed Central

Steele, Rachel; Tiffin, Paul A.

2014-01-01

Aims and method To evaluate the feasibility of integrating a clinical librarian (CL) within four mental health teams. A CL was attached to three clinical teams and the Trustwide Psychology Research and Clinical Governance Structure for 12 months. Requests for evidence syntheses were recorded. The perceived impact of individual evidence summaries on staff activities was evaluated using a brief online questionnaire. Results Overall, 82 requests for evidence summaries were received: 50% related to evidence for individual patient care, 23% to generic clinical issues and 27% were on management/corporate topics. In the questionnaires 105 participants indicated that the most common impact on their practice was advice given to colleagues (51 respondents), closely followed by the evidence summaries stimulating new ideas for patient care or treatment (50 respondents). Clinical implications The integration of a CL into clinical and corporate teams is feasible and perceived as having an impact on staff activities. A CL may be able to collate ‘personalised evidence’ which may enhance individualised healthcare. In some cases the usual concept of a hierarchy of evidence may not easily apply, with case reports providing guidance which may be more applicable than population-based studies. PMID:25237487

QIN. Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials

PubMed Central

Doot, Robert K.; Thompson, Tove; Greer, Benjamin E.; Allberg, Keith C.; Linden, Hannah M.; Mankoff, David A.; Kinahan, Paul E.

2012-01-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging is a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. PMID:22795929

Early experiences in establishing a regional quantitative imaging network for PET/CT clinical trials.

PubMed

Doot, Robert K; Thompson, Tove; Greer, Benjamin E; Allberg, Keith C; Linden, Hannah M; Mankoff, David A; Kinahan, Paul E

2012-11-01

The Seattle Cancer Care Alliance (SCCA) is a Pacific Northwest regional network that enables patients from community cancer centers to participate in multicenter oncology clinical trials where patients can receive some trial-related procedures at their local center. Results of positron emission tomography (PET) scans performed at community cancer centers are not currently used in SCCA Network trials since clinical trials customarily accept results from only trial-accredited PET imaging centers located at academic and large hospitals. Oncologists would prefer the option of using standard clinical PET scans from Network sites in multicenter clinical trials to increase accrual of patients for whom additional travel requirements for imaging are a barrier to recruitment. In an effort to increase accrual of rural and other underserved populations to Network trials, researchers and clinicians at the University of Washington, SCCA and its Network are assessing the feasibility of using PET scans from all Network sites in their oncology clinical trials. A feasibility study is required because the reproducibility of multicenter PET measurements ranges from approximately 3% to 40% at national academic centers. Early experiences from both national and local PET phantom imaging trials are discussed, and next steps are proposed for including patient PET scans from the emerging regional quantitative imaging network in clinical trials. There are feasible methods to determine and characterize PET quantitation errors and improve data quality by either prospective scanner calibration or retrospective post hoc corrections. These methods should be developed and implemented in multicenter clinical trials employing quantitative PET imaging of patients. Copyright © 2012 Elsevier Inc. All rights reserved.

Hyperspectral wide gap second derivative analysis for in vivo detection of cervical intraepithelial neoplasia

NASA Astrophysics Data System (ADS)

Zheng, Wenli; Wang, Chaojian; Chang, Shufang; Zhang, Shiwu; Xu, Ronald X.

2015-12-01

Hyperspectral reflectance imaging technique has been used for in vivo detection of cervical intraepithelial neoplasia. However, the clinical outcome of this technique is suboptimal owing to multiple limitations such as nonuniform illumination, high-cost and bulky setup, and time-consuming data acquisition and processing. To overcome these limitations, we acquired the hyperspectral data cube in a wavelength ranging from 600 to 800 nm and processed it by a wide gap second derivative analysis method. This method effectively reduced the image artifacts caused by nonuniform illumination and background absorption. Furthermore, with second derivative analysis, only three specific wavelengths (620, 696, and 772 nm) are needed for tissue classification with optimal separability. Clinical feasibility of the proposed image analysis and classification method was tested in a clinical trial where cervical hyperspectral images from three patients were used for classification analysis. Our proposed method successfully classified the cervix tissue into three categories of normal, inflammation and high-grade lesion. These classification results were coincident with those by an experienced gynecology oncologist after applying acetic acid. Our preliminary clinical study has demonstrated the technical feasibility for in vivo and noninvasive detection of cervical neoplasia without acetic acid. Further clinical research is needed in order to establish a large-scale diagnostic database and optimize the tissue classification technique.

Hyperspectral wide gap second derivative analysis for in vivo detection of cervical intraepithelial neoplasia.

PubMed

Zheng, Wenli; Wang, Chaojian; Chang, Shufang; Zhang, Shiwu; Xu, Ronald X

2015-12-01

Hyperspectral reflectance imaging technique has been used for in vivo detection of cervical intraepithelial neoplasia. However, the clinical outcome of this technique is suboptimal owing to multiple limitations such as nonuniform illumination, high-cost and bulky setup, and time-consuming data acquisition and processing. To overcome these limitations, we acquired the hyperspectral data cube in a wavelength ranging from 600 to 800 nm and processed it by a wide gap second derivative analysis method. This method effectively reduced the image artifacts caused by nonuniform illumination and background absorption. Furthermore, with second derivative analysis, only three specific wavelengths (620, 696, and 772 nm) are needed for tissue classification with optimal separability. Clinical feasibility of the proposed image analysis and classification method was tested in a clinical trial where cervical hyperspectral images from three patients were used for classification analysis. Our proposed method successfully classified the cervix tissue into three categories of normal, inflammation and high-grade lesion. These classification results were coincident with those by an experienced gynecology oncologist after applying acetic acid. Our preliminary clinical study has demonstrated the technical feasibility for in vivo and noninvasive detection of cervical neoplasia without acetic acid. Further clinical research is needed in order to establish a large-scale diagnostic database and optimize the tissue classification technique.

4D co-registration of X-ray and MR-mammograms: initial clinical results and potential incremental diagnostic value.

PubMed

Dietzel, Matthias; Hopp, Torsten; Ruiter, Nicole V; Kaiser, Clemens G; Kaiser, Werner A; Baltzer, Pascal A

2015-01-01

4D co-registration of X-ray- and MR-mammograms (XM and MM) is a new method of image fusion. The present study aims to evaluate its clinical feasibility, radiological accuracy, and potential clinical value. XM and MM of 25 patients were co-registered. Results were evaluated by a blinded reader. Precision of the 4D co-registration was "very good" (mean-score [ms]=7), and lesions were "easier to delineate" (ms=5). In 88.8%, "relevant additional diagnostic information" was present, accounting for a more "confident diagnosis" in 76% (ms=5). 4D co-registration is feasible, accurate, and of potential clinical value. Copyright © 2015 Elsevier Inc. All rights reserved.

Feasibility trial of a Spanish-language multimedia educational intervention.

PubMed

Wells, Kristen J; McIntyre, Jessica; Gonzalez, Luis E; Lee, Ji-Hyun; Fisher, Kate J; Jacobsen, Paul B; Meade, Cathy; Muñoz-Antonia, Teresita; Quinn, Gwendolyn P

2013-10-01

Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family. Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics. A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later. Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial. Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations. In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.

The feasibility, perceived satisfaction, and value of using synchronous webinars to educate clinical research professionals on reporting adverse events in clinical trials: a report from the Children's Oncology Group.

PubMed

Borgerson, Dawn; Dino, Jennifer

2012-01-01

Clinical research professionals are faced with decreased funding and increased workloads; innovative methods of professional development programs are necessary to accommodate these factors. This study evaluated the feasibility, perceived satisfaction, and value of using webinars to educate clinical research professionals on reporting adverse events commonly experienced in pediatric oncology clinical trials. The setting incorporated synchronous web-based educational technology. Constructivist learning provides the theoretical framework for this study. Participants evaluated the professional development program at 2 time points: (a) at the conclusion and (b) 4 to 6 weeks afterward, using survey method. Synchronous webinars were both economical and effective in educating clinical research professionals across institutional sites. Participants reported exceptionally high levels of satisfaction with the accessibility, scope, quality, and interactivity of the professional development program. The vast majority of participants reported that the education would assist with reporting adverse events in pediatric oncology clinical trials and this perception persisted into clinical practice. Although the results of this study were intended to guide future educational efforts of the Children's Oncology Group, they may also apply to other cooperative groups.

A pilot study to explore the feasibility of using theClinical Care Classification System for developing a reliable costing method for nursing services.

PubMed

Dykes, Patricia C; Wantland, Dean; Whittenburg, Luann; Lipsitz, Stuart; Saba, Virginia K

2013-01-01

While nursing activities represent a significant proportion of inpatient care, there are no reliable methods for determining nursing costs based on the actual services provided by the nursing staff. Capture of data to support accurate measurement and reporting on the cost of nursing services is fundamental to effective resource utilization. Adopting standard terminologies that support tracking both the quality and the cost of care could reduce the data entry burden on direct care providers. This pilot study evaluated the feasibility of using a standardized nursing terminology, the Clinical Care Classification System (CCC), for developing a reliable costing method for nursing services. Two different approaches are explored; the Relative Value Unit RVU and the simple cost-to-time methods. We found that the simple cost-to-time method was more accurate and more transparent in its derivation than the RVU method and may support a more consistent and reliable approach for costing nursing services.

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

Evaluation of the acceptability, feasibility and effectiveness of two methods of involving patients with disability in developing clinical guidelines: study protocol of a randomized pragmatic pilot trial.

PubMed

Lamontagne, Marie-Eve; Perreault, Kadija; Gagnon, Marie-Pierre

2014-04-10

Despite growing interest in the importance of, and challenges associated with the involvement of patient and population (IPP) in the process of developing and adapting clinical practice guidelines (CPGs), there is a lack of knowledge about the best method to use. This is especially problematic in the field of rehabilitation, where individuals with disabilities might face many barriers to their involvement in the guideline development and adaptation process. The goal of this pilot trial is to document the acceptability, feasibility and effectiveness of two methods of involving patients with a disability (traumatic brain injury) in CPG development. A single-blind, randomized, crossover pragmatic trial will be performed with 20 patients with traumatic brain injury (TBI). They will be randomized into two groups, and each will try two alternative methods of producing recommendations; a discussion group (control intervention) and a Wiki, a webpage that can be modified by those who have access to it (experimental intervention). The participants will rate the acceptability of the two methods, and feasibility will be assessed using indicators such as the number of participants who accessed and completed the two methods, and the number of support interventions required. Twenty experts, blinded to the method of producing the recommendations, will independently rate the recommendations produced by the participants for clarity, accuracy, appropriateness and usefulness. Our trial will allow for the use of optimal IPP methods in a larger project of adapting guidelines for the rehabilitation of individuals with TBI. Ultimately the results will inform the science of CPG development and contribute to the growing knowledge about IPP in rehabilitation settings. Clinical trial KT Canada 87776.

Disease-specific clinical pathways - are they feasible in primary care? A mixed-methods study.

PubMed

Grimsmo, Anders; Løhre, Audhild; Røsstad, Tove; Gjerde, Ingunn; Heiberg, Ina; Steinsbekk, Aslak

2018-06-01

To explore the feasibility of disease-specific clinical pathways when used in primary care. A mixed-method sequential exploratory design was used. First, merging and exploring quality interview data across two cases of collaboration between the specialist care and primary care on the introduction of clinical pathways for four selected chronic diseases. Secondly, using quantitative data covering a population of 214,700 to validate and test hypothesis derived from the qualitative findings. Primary care and specialist care collaborating to manage care coordination. Primary-care representatives expressed that their patients often have complex health and social needs that clinical pathways guidelines seldom consider. The representatives experienced that COPD, heart failure, stroke and hip fracture, frequently seen in hospitals, appear in low numbers in primary care. The quantitative study confirmed the extensive complexity among home healthcare nursing patients and demonstrated that, for each of the four selected diagnoses, a homecare nurse on average is responsible for preparing reception of the patient at home after discharge from hospital, less often than every other year. The feasibility of disease-specific pathways in primary care is limited, both from a clinical and organisational perspective, for patients with complex needs. The low prevalence in primary care of patients with important chronic conditions, needing coordinated care after hospital discharge, constricts transferring tasks from specialist care. Generic clinical pathways are likely to be more feasible and efficient for patients in this setting. Key points Clinical pathways in hospitals apply to single-disease guidelines, while more than 90% of the patients discharged to community health care for follow-up have multimorbidity. Primary care has to manage the health care of the patient holistically, with all his or her complex needs. Patients most frequently admitted to hospitals, i.e. patients with COPD, heart failure, stroke and hip fracture are infrequent in primary care and represent a minority among patients in need of coordinated community health care. In primary care, the low rate of receiving patients discharged from hospitals of major chronic diseases hampers maintenance of required specific skills, thus constricting the transfer of tasks to primary care. Generic clinical pathways are suggested to be more feasible than disease-specific pathways for most patients with complex needs.

Feasibility of Extracting Key Elements from ClinicalTrials.gov to Support Clinicians’ Patient Care Decisions

PubMed Central

Kim, Heejun; Bian, Jiantao; Mostafa, Javed; Jonnalagadda, Siddhartha; Del Fiol, Guilherme

2016-01-01

Motivation: Clinicians need up-to-date evidence from high quality clinical trials to support clinical decisions. However, applying evidence from the primary literature requires significant effort. Objective: To examine the feasibility of automatically extracting key clinical trial information from ClinicalTrials.gov. Methods: We assessed the coverage of ClinicalTrials.gov for high quality clinical studies that are indexed in PubMed. Using 140 random ClinicalTrials.gov records, we developed and tested rules for the automatic extraction of key information. Results: The rate of high quality clinical trial registration in ClinicalTrials.gov increased from 0.2% in 2005 to 17% in 2015. Trials reporting results increased from 3% in 2005 to 19% in 2015. The accuracy of the automatic extraction algorithm for 10 trial attributes was 90% on average. Future research is needed to improve the algorithm accuracy and to design information displays to optimally present trial information to clinicians. PMID:28269867

Randomized Multicenter Feasibility Trial of Myofascial Physical Therapy for Treatment of Urologic Chronic Pelvic Pain Syndrome

PubMed Central

FitzGerald, Mary P; Anderson, Rodney U; Potts, Jeannette; Payne, Christopher K; Peters, Kenneth M; Clemens, J Quentin; Kotarinos, Rhonda; Fraser, Laura; Cosby, Annamarie; Fortman, Carole; Neville, Cynthia; Badillo, Suzanne; Odabachian, Lisa; Sanfield, Anna; O’Dougherty, Betsy; Halle-Podell, Rick; Cen, Liyi; Chuai, Shannon; Landis, J Richard; Kusek, John W; Nyberg, Leroy M

2010-01-01

Objectives To determine the feasibility of conducting a randomized clinical trial designed to compare two methods of manual therapy (myofascial physical therapy (MPT) and global therapeutic massage (GTM)) among patients with urologic chronic pelvic pain syndromes. Materials and Methods Our goal was to recruit 48 subjects with chronic prostatitis/chronic pelvic pain syndrome or interstitial cystitis/painful bladder syndrome at six clinical centers. Eligible patients were randomized to either MPT or GTM and were scheduled to receive up to 10 weekly treatments, each 1 hour in duration. Criteria to assess feasibility included adherence of therapists to prescribed therapeutic protocol as determined by records of treatment, adverse events which occurred during study treatment, and rate of response to therapy as assessed by the Patient Global Response Assessment (GRA). Primary outcome analysis compared response rates between treatment arms using Mantel-Haenszel methods. Results Twenty-three (49%) men and 24 (51%) women were randomized over a six month period. Twenty-four (51%) patients were randomized to GTM, 23 (49%) to MPT; 44 (94%) patients completed the study. Therapist adherence to the treatment protocols was excellent. The GRA response rate of 57% in the MPT group was significantly higher than the rate of 21% in the GTM treatment group (p=0.03). Conclusions The goals to judge feasibility of conducting a full-scale trial of physical therapy methods were met. The preliminary findings of a beneficial effect of MPT warrants further study. PMID:19535099

Promoting student case creation to enhance instruction of clinical reasoning skills: a pilot feasibility study.

PubMed

Chandrasekar, Hamsika; Gesundheit, Neil; Nevins, Andrew B; Pompei, Peter; Bruce, Janine; Merrell, Sylvia Bereknyei

2018-01-01

It is a common educational practice for medical students to engage in case-based learning (CBL) exercises by working through clinical cases that have been developed by faculty. While such faculty-developed exercises have educational strengths, there are at least two major drawbacks to learning by this method: the number and diversity of cases is often limited; and students decrease their engagement with CBL cases as they grow accustomed to the teaching method. We sought to explore whether student case creation can address both of these limitations. We also compared student case creation to traditional clinical reasoning sessions in regard to tutorial group effectiveness, perceived gains in clinical reasoning, and quality of student-faculty interaction. Ten first-year medical students participated in a feasibility study wherein they worked in small groups to develop their own patient case around a preassigned diagnosis. Faculty provided feedback on case quality afterwards. Students completed pre- and post-self-assessment surveys. Students and faculty also participated in separate focus groups to compare their case creation experience to traditional CBL sessions. Students reported high levels of team engagement and peer learning, as well as increased ownership over case content and understanding of clinical reasoning nuances. However, students also reported decreases in student-faculty interaction and the use of visual aids ( P < 0.05). The results of our feasibility study suggest that student-generated cases can be a valuable adjunct to traditional clinical reasoning instruction by increasing content ownership, encouraging student-directed learning, and providing opportunities to explore clinical nuances. However, these gains may reduce student-faculty interaction. Future studies may be able to identify an improved model of faculty participation, the ideal timing for incorporation of this method in a medical curriculum, and a more rigorous assessment of the impact of student case creation on the development of clinical reasoning skills.

Feasibility of feature-based indexing, clustering, and search of clinical trials. A case study of breast cancer trials from ClinicalTrials.gov.

PubMed

Boland, M R; Miotto, R; Gao, J; Weng, C

2013-01-01

When standard therapies fail, clinical trials provide experimental treatment opportunities for patients with drug-resistant illnesses or terminal diseases. Clinical Trials can also provide free treatment and education for individuals who otherwise may not have access to such care. To find relevant clinical trials, patients often search online; however, they often encounter a significant barrier due to the large number of trials and in-effective indexing methods for reducing the trial search space. This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. We decomposed 80 randomly selected stage III breast cancer clinical trials into a vector of eligibility features, which were organized into a hierarchy. We clustered trials based on their eligibility feature similarities. In a simulated search process, manually selected features were used to generate specific eligibility questions to filter trials iteratively. We extracted 1,437 distinct eligibility features and achieved an inter-rater agreement of 0.73 for feature extraction for 37 frequent features occurring in more than 20 trials. Using all the 1,437 features we stratified the 80 trials into six clusters containing trials recruiting similar patients by patient-characteristic features, five clusters by disease-characteristic features, and two clusters by mixed features. Most of the features were mapped to one or more Unified Medical Language System (UMLS) concepts, demonstrating the utility of named entity recognition prior to mapping with the UMLS for automatic feature extraction. It is feasible to develop feature-based indexing and clustering methods for clinical trials to identify trials with similar target populations and to improve trial search efficiency.

Visualization of Skin Perfusion by Indocyanine Green Fluorescence Angiography—A Feasibility Study

PubMed Central

Steinbacher, Johannes; Yoshimatsu, Hidehiko; Meng, Stefan; Hamscha, Ulrike M.; Chan, Chun-Sheng; Weninger, Wolfgang J.; Wu, Chieh-Tsai; Cheng, Ming-Huei

2017-01-01

Summary: Plastic and reconstructive surgery relies on the knowledge of angiosomes in the raising of microsurgical flaps. Growing interest in muscle-sparing perforator flaps calls for reliable methods to assess the clinical feasibility of new donor sites in anatomical studies. Several injection techniques are known for the evaluation of vascular territories. Indocyanine green–based fluorescence angiography has found wide application in the clinical assessment of tissue perfusion. In this article, the use of indocyanine green–based fluorescence angiography for the assessment of perforasomes in anatomical studies is described for the first time. PMID:29062637

Improving the healthcare response to domestic violence and abuse in sexual health clinics: feasibility study of a training, support and referral intervention

PubMed Central

Sohal, Alex Hardip; Pathak, Neha; Blake, Sarah; Apea, Vanessa; Berry, Judith; Bailey, Jayne; Griffiths, Chris; Feder, Gene

2018-01-01

Objectives Sexual health and gynaecological problems are the most consistent and largest physical health differences between abused and non-abused female populations. Sexual health services are well placed to identify and support patients experiencing domestic violence and abuse (DVA). Most sexual health professionals have had minimal DVA training despite English National Institute for Health and Care Excellence recommendations. We sought to determine the feasibility of an evidence-based complex DVA training intervention in female sexual health walk-in services (IRIS ADViSE: Identification and Referral to Improve Safety whilst Assessing Domestic Violence in Sexual Health Environments). Methods An adaptive mixed method pilot study in the female walk-in service of two sexual health clinics. Following implementation and evaluation at site 1, the intervention was refined before implementation at site 2. The intervention comprised electronic prompts, multidisciplinary training sessions, clinic materials and simple referral pathways to IRIS ADViSE advocate-educators (AEs). The pilot lasted 7 weeks at site 1 and 12 weeks at site 2. Feasibility outcomes were to assign a supportive DVA clinical lead, an IRIS ADViSE AE employed by a local DVA service provider, adapt electronic records, develop local referral pathways, assess whether enquiry, identification and referral rates were measurable. Results Both sites achieved all feasibility outcomes: appointing a supportive DVA clinical lead and IRIS ADViSE AE, establishing links with a local DVA provider, adapting electronic records, developing local referral pathways and rates of enquiry, identification and referral were found to be measurable. Site 1: 10% enquiry rate (n=267), 4% identification rate (n=16) and eight AE referrals. Site 2: 61% enquiry rate (n=1090), a 7% identification rate (n=79) and eight AE referrals. Conclusions IRIS ADViSE can be successfully developed and implemented in sexual health clinics. It fulfils the unmet need for DVA training. Longer-term evaluation is recommended. PMID:28724743

From impedance theory to needle electrode guidance in tissue

NASA Astrophysics Data System (ADS)

Kalvøy, Håvard; Høyum, Per; Grimnes, Sverre; Martinsen, Ørjan G.

2010-04-01

Fast access to blood vessels or other tissues/organs can be crucial in clinical or acute medical treatment. We have developed a method for needle guidance for use in different types of applications. The feasibility of an automatic application for fast access to blood vessels during acute cardiac arrest, based on this method, has been evaluated. Suited electrode setups were found by development of needle electrode models used in simulation and sensitivity analyses. In vitro measurements were done both to determine the fundamental properties of the electrodes for use in the models and to confirm the simulation results. Development of algorithms for tissue characterization and differentiation was based on in vivo impedance measurement in porcine models and confirmed in human tissue in vivo. Feasibility was proven by application prototyping and impedance data presented as invasive Electrical Impedance Tomography (iEIT). Our conclusion is that this method can be utilized in a wide range of clinical applications.

Evaluation of Collaterals and Clot Burden Using Time-Resolved C-Arm Conebeam CT Angiography in the Angiography Suite: A Feasibility Study.

PubMed

Yang, P; Niu, K; Wu, Y; Struffert, T; Doerfler, A; Holter, P; Aagaard-Kienitz, B; Strother, C; Chen, G-H

2017-04-01

The assessment of collaterals and clot burden in patients with acute ischemic stroke provides important information about treatment options and clinical outcome. Time-resolved C-arm conebeam CT angiography has the potential to provide accurate and reliable evaluations of collaterals and clot burden in the angiographic suite. Experience with this technique is extremely limited, and feasibility studies are needed to validate this technique. Our purpose was to present such a feasibility study. Ten C-arm conebeam CT perfusion datasets from 10 subjects with acute ischemic stroke acquired before endovascular treatment were retrospectively processed to generate time-resolved conebeam CTA. From time-resolved conebeam CTA, 2 experienced readers evaluated the clot burden and collateral flow in consensus by using previously reported scoring systems and assessed the clinical value of this novel imaging technique independently. Interobserver agreement was analyzed by using the intraclass correlation analysis method. Clot burden and collateral flow can be assessed by using the commonly accepted scoring systems for all eligible cases. Additional clinical information (eg, the quantitative dynamic information of collateral flow) can be obtained from this new imaging technique. Two readers agreed that time-revolved C-arm conebeam CTA is the preferred method for evaluating the clot burden and collateral flow compared with other conventional imaging methods. Comprehensive evaluations of clot burden and collateral flow are feasible by using time-resolved C-arm conebeam CTA data acquired in the angiography suite. This technique further enriches the imaging tools in the angiography suite to enable a "one-stop- shop" imaging workflow for patients with acute ischemic stroke. © 2017 by American Journal of Neuroradiology.

Feasibility of peer assessment and clinical audit to self-regulate the quality of physiotherapy services: a mixed methods study

PubMed Central

Nijhuis-van der Sanden, Maria W G; Driehuis, Femke; Heerkens, Yvonne F; van der Vleuten, Cees P M; van der Wees, Philip J

2017-01-01

Objectives To evaluate the feasibility of a quality improvement programme aimed to enhance the client-centeredness, effectiveness and transparency of physiotherapy services by addressing three feasibility domains: (1) acceptability of the programme design, (2) appropriateness of the implementation strategy and (3) impact on quality improvement. Design Mixed methods study. Participants and setting 64 physiotherapists working in primary care, organised in a network of communities of practice in the Netherlands. Methods The programme contained: (1) two cycles of online self-assessment and peer assessment (PA) of clinical performance using client records and video-recordings of client communication followed by face-to-face group discussions, and (2) clinical audit assessing organisational performance. Assessment was based on predefined performance indicators which could be scored on a 5-point Likert scale. Discussions addressed performance standards and scoring differences. All feasibility domains were evaluated qualitatively with two focus groups and 10 in-depth interviews. In addition, we evaluated the impact on quality improvement quantitatively by comparing self-assessment and PA scores in cycles 1 and 2. Results We identified critical success features relevant to programme development and implementation, such as clarifying expectations at baseline, training in PA skills, prolonged engagement with video-assessment and competent group coaches. Self-reported impact on quality improvement included awareness of clinical and organisational performance, improved evidence-based practice and client-centeredness and increased motivation to self-direct quality improvement. Differences between self-scores and peer scores on performance indicators were not significant. Between cycles 1 and 2, scores for record keeping showed significant improvement, however not for client communication. Conclusions This study demonstrated that bottom-up initiatives to improve healthcare quality can be effective. The results justify ongoing evaluation to inform nationwide implementation when the critical success features are addressed. Further research is necessary to explore the sustainability of the results and the impact on client outcomes in a full-scale study. PMID:28188156

The Aging, Community and Health Research Unit-Community Partnership Program for older adults with type 2 diabetes and multiple chronic conditions: a feasibility study.

PubMed

Markle-Reid, Maureen; Ploeg, Jenny; Fisher, Kathryn; Reimer, Holly; Kaasalainen, Sharon; Gafni, Amiram; Gruneir, Andrea; Kirkconnell, Ross; Marzouk, Sam; Akhtar-Danesh, Noori; Thabane, Lehana; Rojas-Fernandez, Carlos; Upshur, Ross

2016-01-01

Few studies have examined the effectiveness of community-based self-management interventions in older adults with type 2 diabetes mellitus (T2DM) and multiple chronic conditions (MCC). The objectives of this study were to examine the feasibility of implementation in practice (primary) and the feasibility of study methods and potential effectiveness (secondary) of the Aging, Community and Health-Community Partnership Program, a new 6-month interprofessional, nurse-led program to promote diabetes self-management in older adults (>65 years) with T2DM and MCC. This study used a prospective one-group pre-test/post-test design. Participants were recruited from a specialized diabetes clinic. They received a median of three in-home/clinic visits by certified diabetes educators (CDEs) and attended a median of three group wellness sessions provided by the CDEs in partnership with a community-based seniors' association. The primary outcome was the feasibility of the program (acceptability, fidelity, implementation barriers/facilitators). Secondary outcomes included the feasibility of the study methods (recruitment/retention rates and procedures, eligibility criteria, data collection and analysis methods) and potential effectiveness of the program based on 6-month changes in self-reported outcomes including self-management behavior (diet, exercise, self-monitoring), health status (quality of life, mental health), and costs of service use. Analysis of feasibility outcomes was primarily based on descriptive statistics. The potential effectiveness of the program was explored using different tests, with the results expressed using descriptive statistics and effect estimates (95 % confidence intervals). In total, 45 (88 %) of 51 eligible persons consented to participate. Of these, 37 (82 %) completed the 6-month follow-up. Participants and providers viewed the program as acceptable and feasible. Participants had a higher SF-12 physical component summary score at 6 months compared with baseline (mean score difference 3.0, 95 % CI 0.2-5.8). Median costs for diabetes care increased over 6 months (reflecting inclusion of program costs), while other service costs either decreased or remained unchanged. This study offers preliminary evidence that the program was feasible to deliver and acceptable to participants and providers. Initial results suggest that the program may improve physical functioning. A randomized controlled trial is feasible, with some adaptations to the program and study methods that were identified from this feasibility study. Clinicaltrials.gov identifier: NCT01880476.

Feasibility of a Sensory-Adapted Dental Environment for Children With Autism

PubMed Central

Stein Duker, Leah I.; Williams, Marian E.; Lane, Christianne Joy; Dawson, Michael E.; Borreson, Ann E.; Polido, José C.

2015-01-01

OBJECTIVE. To provide an example of an occupational therapy feasibility study and evaluate the implementation of a randomized controlled pilot and feasibility trial examining the impact of a sensory-adapted dental environment (SADE) to enhance oral care for children with autism spectrum disorder (ASD). METHOD. Twenty-two children with ASD and 22 typically developing children, ages 6–12 yr, attended a dental clinic in an urban hospital. Participants completed two dental cleanings, 3–4 mo apart, one in a regular environment and one in a SADE. Feasibility outcome measures were recruitment, retention, accrual, dropout, and protocol adherence. Intervention outcome measures were physiological stress, behavioral distress, pain, and cost. RESULTS. We successfully recruited and retained participants. Parents expressed satisfaction with research study participation. Dentists stated that the intervention could be incorporated in normal practice. Intervention outcome measures favored the SADE condition. CONCLUSION. Preliminary positive benefit of SADE in children with ASD warrants moving forward with a large-scale clinical trial. PMID:25871593

Is a decentralized continuing medical education program feasible for Chinese rural health professionals?

PubMed Central

2016-01-01

Purpose: Rural health professionals in township health centers (THCs) tend to have less advanced educational degrees. This study aimed to ascertain the perceived feasibility of a decentralized continuing medical education (CME) program to upgrade their educational levels. Methods: A cross-sectional survey of THC health professionals was conducted using a self-administered, structured questionnaire in Guangxi Zhuang Autonomous Region, China. Results: The health professionals in the THCs were overwhelmingly young with low education levels. They had a strong desire to upgrade their educational degrees. The decentralized CME program was perceived as feasible by health workers with positive attitudes about the benefit for license examination, and by those who intended to improve their clinical diagnosis and treatment skills. The target groups of such a program were those who expected to undertake a bachelor’s degree and who rated themselves as “partially capable” in clinical competency. They reported that 160-400 USD annually would be an affordable fee for the program. Conclusion: A decentralized CME program was perceived feasible to upgrade rural health workers’ education level to a bachelor’s degree and improve their clinical competency. PMID:27134005

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study

PubMed Central

Chignell, Mark; Tierney, Mary C.; Lee, Jacques

2016-01-01

Background We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. Objective The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. Methods We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). Results After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=–.339, P <.001) and MMSE (r=–.558, P <.001), and correlated (point-biserial correlation) with the CAM (r=.565, P <.001) and with other cognitive assessments. Conclusions This research demonstrates the feasibility of using serious games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making. PMID:27234145

Development of an assist controller with robot suit HAL for hemiplegic patients using motion data on the unaffected side.

PubMed

Kawamoto, Hiroaki; Kandone, Hideki; Sakurai, Takeru; Ariyasu, Ryohei; Ueno, Yukiko; Eguchi, Kiyoshi; Sankai, Yoshiyuki

2014-01-01

Among several characteristics seen in gait of hemiplegic patients after stroke, symmetry is known to be an indicator of the degree of impairment of walking ability. This paper proposes a control method for a wearable type lower limb motion assist robot to realize spontaneous symmetric gait for these individuals. This control method stores the motion of the unaffected limb during swing and then provides motion support on the affected limb during the subsequent swing using the stored pattern to realize symmetric gait based on spontaneous limb swing. This method is implemented on the robot suit HAL (Hybrid Assistive Limbs). Clinical tests were conducted in order to assess the feasibility of the control method. Our case study involved participation of one chronic stroke patient who was not able to flex his right knee. As a result, the walking support for hemiplegic leg provided by the HAL improved the subject's gait symmetry. The feasibility study showed promising basis for the future clinical study.

Tobacco Harm Reduction with Vaporised Nicotine (THRiVe): The Study Protocol of an Uncontrolled Feasibility Study of Novel Nicotine Replacement Products among People Living with HIV Who Smoke.

PubMed

Bell, Stephanie; Dean, Judith; Gilks, Charles; Boyd, Mark A; Fitzgerald, Lisa; Mutch, Allyson; Baker, Peter; Neilsen, Graham; Gartner, Coral E

2017-07-18

Smoking is a leading cause of morbidity and premature mortality among people living with HIV (PLHIV), who have high rates of tobacco smoking. Vaporised nicotine products (VNPs) are growing in popularity as a quit aid and harm reduction tool. However, little is known about their acceptability and use among PLHIV. Using a pragmatic, uncontrolled, mixed methods design this exploratory clinical trial aims to examine the feasibility of conducting a powered randomised clinical trial of VNPs as a smoking cessation and harm reduction intervention among vulnerable populations, such as PLHIV who smoke tobacco. Convenience sampling and snowball methods will be used to recruit participants (N = 30) who will receive two VNPs and up to 12 weeks' supply of nicotine e-liquid to use in a quit attempt. Surveys will be completed at weeks 0 (baseline), 4, 8, 12 (end of treatment) and 24 (end of the study) and qualitative interviews at weeks 0 and 12. As far as we are aware, this feasibility study is the first to trial VNPs among PLHIV for smoking cessation. If feasible and effective, this intervention could offer a new approach to reducing the high burden of tobacco-related disease among PLHIV and other vulnerable populations.

Development and Initial Testing of a Structured Clinical Observation Tool to Assess Pharmacotherapy Competence

ERIC Educational Resources Information Center

Young, John Q.; Lieu, Sandra; O'Sullivan, Patricia; Tong, Lowell

2011-01-01

Objective: The authors developed and tested the feasibility and utility of a new direct-observation instrument to assess trainee performance of a medication management session. Methods: The Psychopharmacotherapy-Structured Clinical Observation (P-SCO) instrument was developed based on multiple sources of expertise and then implemented in 4…

Understanding Patient Experience Using Internet-based Email Surveys: A Feasibility Study at Mount Sinai Hospital.

PubMed

Morgan, Matthew; Lau, Davina; Jivraj, Tanaz; Principi, Tania; Dietrich, Sandra; Bell, Chaim M

2015-01-01

Email is becoming a widely accepted communication tool in healthcare settings. This study sought to test the feasibility of Internet-based email surveys of patient experience in the ambulatory setting. We conducted a study of email Internet-based surveys sent to patients in selected ambulatory clinics at Mount Sinai Hospital in Toronto, Canada. Our findings suggest that email links to Internet surveys are a feasible, timely and efficient method to solicit patient feedback about their experience. Further research is required to optimally leverage Internet-based email surveys as a tool to better understand the patient experience.

Adapting and Testing Telephone Based Depression Care Management Intervention for Adolescent Mothers

PubMed Central

Logsdon, M. Cynthia; Pinto-Foltz, Melissa D.; Stein, Bradley; Usui, Wayne; Josephson, Allan

2011-01-01

Purpose and Methods This Phase 1 clinical trial combined qualitative and quantitative methods to modify a collaborative care, telephone based, depression care management intervention for adolescent mothers, and to determine the acceptability, feasibility, and initial efficacy of the intervention in a sample of adolescent mothers (n=97) who were recruited from a Teen Parent Program. Outcomes included measures of depressive symptoms, functioning, and use of mental health services. Results Acceptability of the intervention was demonstrated, but feasibility issues related to the complex life challenges confronting the adolescent mother. Although only four adolescent mothers received mental health treatment, there was a trend for improved depressive symptoms over time. Conclusion Results of the study provide data for the need of further refinement of the intervention before a large clinical trial is conducted for adolescent mothers with symptoms of depression. PMID:20020164

[Screening of sexually transmitted diseases in clinical and non-clinical settings in Salvador, Bahia, Brazil].

PubMed

de Codes, José Santiago; Cohen, Deborah Ann; de Melo, Neli Almeida; Teixeira, Guilherme Gonzaga; Leal, Alexandre dos Santos; Silva, Tiago de Jesus; de Oliveira, Miucha Pereira Rios

2006-02-01

The objectives were to study: (1) acceptance of STD screening in non-clinical settings for asymptomatic individuals; (2) risk factors and STD prevalence among individuals in non-clinical and clinical settings; and (3) non-clinical screening of asymptomatic populations as a feasible method for STD control. We recruited 139 males and 486 females between 18 and 30 years of age from a family planning clinic, schools, and community centers in low-income neighborhoods. We asked about STD symptoms and STD/HIV risk behaviors and tested the individuals for gonorrhea, Chlamydia, syphilis, and HIV. Except for HIV, women recruited directly from the community had higher STD rates than those who came in for care at the clinic. Screening in non-clinical settings in Brazil is feasible and has a high yield among young adults in low-income communities. Infected participants would likely never have otherwise sought care or been tested or treated. STD control efforts could be implemented in any site that can reach populations at risk and become a routine procedure in health care settings where people report for problems unrelated to STDs.

Accrual and Recruitment Practices at Clinical and Translational Science Award (CTSA) Institutions: A Call for Expectations, Expertise, and Evaluation

PubMed Central

Kost, Rhonda G.; Mervin-Blake, Sabrena; Hallarn, Rose; Rathmann, Charles; Kolb, H. Robert; Himmelfarb, Cheryl Dennison; D’Agostino, Toni; Rubinstein, Eric P.; Dozier, Ann M.; Schuff, Kathryn G.

2014-01-01

Purpose To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examine participant recruitment practices at Clinical and Translational Science Award sites (CTSAs) and make recommendations for performance metrics and accountability. Method The CTSA Recruitment and Retention taskforce developed and, in 2010, invited representatives at 46 CTSAs to complete an online 48-question survey querying CTSA accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. Results Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78–91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); their desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to IRB review (30%) or contract approval (22%). All respondents’ IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. Conclusions Many CTSAs lack the necessary framework to support study accrual. Recommendations to enhance accrual include articulating institutional expectations and policy for routine recruitment planning; providing recruitment expertise to inform feasibility assessment and recruitment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices. PMID:24826854

Estimation of the Mean Axon Diameter and Intra-axonal Space Volume Fraction of the Human Corpus Callosum: Diffusion q-space Imaging with Low q-values.

PubMed

Suzuki, Yuriko; Hori, Masaaki; Kamiya, Kouhei; Fukunaga, Issei; Aoki, Shigeki; VAN Cauteren, Marc

2016-01-01

Q-space imaging (QSI) is a diffusion-weighted imaging (DWI) technique that enables investigation of tissue microstructure. However, for sufficient displacement resolution to measure the microstructure, QSI requires high q-values that are usually difficult to achieve with a clinical scanner. The recently introduced "low q-value method" fits the echo attenuation to only low q-values to extract the root mean square displacement. We investigated the clinical feasibility of the low q-value method for estimating the microstructure of the human corpus callosum using a 3.0-tesla clinical scanner within a clinically feasible scan time. We performed a simulation to explore the acceptable range of maximum q-values for the low q-value method. We simulated echo attenuations caused by restricted diffusion in the intra-axonal space (IAS) and hindered diffusion in the extra-axonal space (EAS) assuming 100,000 cylinders with various diameters, and we estimated mean axon diameter, IAS volume fraction, and EAS diffusivity by fitting echo attenuations with different maximum q-values. Furthermore, we scanned the corpus callosum of 7 healthy volunteers and estimated the mean axon diameter and IAS volume fraction. Good agreement between estimated and defined values in the simulation study with maximum q-values of 700 and 800 cm(-1) suggested that the maximum q-value used in the in vivo experiment, 737 cm(-1), was reasonable. In the in vivo experiment, the mean axon diameter was larger in the body of the corpus callosum and smaller in the genu and splenium, and this anterior-to-posterior trend is consistent with previously reported histology, although our mean axon diameter seems larger in size. On the other hand, we found an opposite anterior-to-posterior trend, with high IAS volume fraction in the genu and splenium and a lower fraction in the body, which is similar to the fiber density reported in the histology study. The low q-value method may provide insights into tissue microstructure using a 3T clinical scanner within clinically feasible scan time.

Cultural adaptation of a cognitive-behavioural intervention to improve adherence to antiretroviral therapy among people living with HIV/AIDS in Zimbabwe: Nzira Itsva.

PubMed

Bere, Tarisai; Nyamayaro, Primrose; Magidson, Jessica F; Chibanda, Dixon; Chingono, Alfred; Munjoma, Ronald; Macpherson, Kirsty; Ndhlovu, Chiratidzo Ellen; O'Cleirigh, Conall; Kidia, Khameer; Safren, Steven A; Abas, Melanie

2017-09-01

Few evidence-based interventions to improve adherence to antiretroviral therapy have been adapted for use in Africa. We selected, culturally adapted and tested the feasibility of a cognitive-behavioural intervention for adherence and for delivery in a clinic setting in Harare, Zimbabwe. The feasibility of the intervention was evaluated using a mixed-methods assessment, including ratings of provider fidelity of intervention delivery, and qualitative assessments of feasibility using individual semi-structured interviews with counsellors (n=4) and patients (n=15). The intervention was feasible and acceptable when administered to 42 patients and resulted in improved self-reported adherence in a subset of 15 patients who were followed up after 6months.

Mitigation of adverse interactions in pairs of clinical practice guidelines using constraint logic programming.

PubMed

Wilk, Szymon; Michalowski, Wojtek; Michalowski, Martin; Farion, Ken; Hing, Marisela Mainegra; Mohapatra, Subhra

2013-04-01

We propose a new method to mitigate (identify and address) adverse interactions (drug-drug or drug-disease) that occur when a patient with comorbid diseases is managed according to two concurrently applied clinical practice guidelines (CPGs). A lack of methods to facilitate the concurrent application of CPGs severely limits their use in clinical practice and the development of such methods is one of the grand challenges for clinical decision support. The proposed method responds to this challenge. We introduce and formally define logical models of CPGs and other related concepts, and develop the mitigation algorithm that operates on these concepts. In the algorithm we combine domain knowledge encoded as interaction and revision operators using the constraint logic programming (CLP) paradigm. The operators characterize adverse interactions and describe revisions to logical models required to address these interactions, while CLP allows us to efficiently solve the logical models - a solution represents a feasible therapy that may be safely applied to a patient. The mitigation algorithm accepts two CPGs and available (likely incomplete) patient information. It reports whether mitigation has been successful or not, and on success it gives a feasible therapy and points at identified interactions (if any) together with the revisions that address them. Thus, we consider the mitigation algorithm as an alerting tool to support a physician in the concurrent application of CPGs that can be implemented as a component of a clinical decision support system. We illustrate our method in the context of two clinical scenarios involving a patient with duodenal ulcer who experiences an episode of transient ischemic attack. Copyright © 2013 Elsevier Inc. All rights reserved.

Conducting feasibilities in clinical trials: an investment to ensure a good study.

PubMed

Rajadhyaksha, Viraj

2010-07-01

Conducting clinical trial feasibility is one of the first steps in clinical trial conduct. This process includes assessing internal and environmental capacity, alignment of the clinical trial in terms of study design, dose of investigational product, comparator, patient type, with the local environment and assessing potential of conducting clinical trial in a specific country. A robust feasibility also ensures a realistic assessment and capability to conduct the clinical trial. For local affiliates of pharmaceutical organizations, and contract research organizations, this is a precursor to study placement and influences the decision of study placement. This article provides details on different types of feasibilities, information which is to be included and relevance of each. The article also aims to provide practical hands-on suggestions to make feasibilities more realistic and informative.

Feasibility and validity of computerized ambulatory monitoring in stroke patients.

PubMed

Johnson, E I; Sibon, I; Renou, P; Rouanet, F; Allard, M; Swendsen, J

2009-11-10

Computerized ambulatory monitoring provides real-time assessments of clinical outcomes in natural contexts, and it has been increasingly applied in recent years to investigate symptom expression in a wide range of disorders. The purpose of this study was to examine the feasibility and validity of this data collection strategy with adult stroke patients. Forty-eight individuals (75% of the contacted sample) agreed to participate in the current study and were instructed to complete electronic interviews using a personal digital assistant 5 times per day over a 1-week period. More than 80% of programmed assessments were completed by the sample, and no evidence was found for fatigue effects. Expected patterns of associations were observed among daily life variables, and data collected through ambulatory monitoring were significantly correlated with standard clinic-based measures of similar constructs. Support was found for the feasibility and validity of computerized ambulatory monitoring with stroke patients. The application of these novel methods with stroke patients should provide complementary information that is inaccessible to standard hospital-based assessments and permit increased understanding of the significance of clinical results and test scores for daily life experience.

Health coaching in primary care: a feasibility model for diabetes care

PubMed Central

2014-01-01

Background Health coaching is a new intervention offering a one-on-one focused self-management support program. This study implemented a health coaching pilot in primary care clinics in Eastern Ontario, Canada to evaluate the feasibility and acceptability of integrating health coaching into primary care for patients who were either at risk for or diagnosed with diabetes. Methods We implemented health coaching in three primary care practices. Patients with diabetes were offered six months of support from their health coach, including an initial face-to-face meeting and follow-up by email, telephone, or face-to-face according to patient preference. Feasibility was assessed through provider focus groups and qualitative data analysis methods. Results All three sites were able to implement the program. A number of themes emerged from the focus groups, including the importance of physician buy-in, wide variation in understanding and implementing of the health coach role, the significant impact of different systems of team communication, and the significant effect of organizational structure and patient readiness on Health coaches’ capacity to perform their role. Conclusions It is feasible to implement health coaching as an integrated program within small primary care clinics in Canada without adding additional resources into the daily practice. Practices should review their organizational and communication processes to ensure optimal support for health coaches if considering implementing this intervention. PMID:24708783

Effect, Feasibility, and Clinical Relevance of Cell Enrichment in Large Volume Fat Grafting: A Systematic Review.

PubMed

Rasmussen, Bo Sonnich; Lykke Sørensen, Celine; Vester-Glowinski, Peter Viktor; Herly, Mikkel; Trojahn Kølle, Stig-Frederik; Fischer-Nielsen, Anne; Drzewiecki, Krzysztof Tadeusz

2017-07-01

Large volume fat grafting is limited by unpredictable volume loss; therefore, methods of improving graft retention have been developed. Fat graft enrichment with either stromal vascular fraction (SVF) cells or adipose tissue-derived stem/stromal cells (ASCs) has been investigated in several animal and human studies, and significantly improved graft retention has been reported. Improvement of graft retention and the feasibility of these techniques are equally important in evaluating the clinical relevance of cell enrichment. We conducted a systematic search of PubMed to identify studies on fat graft enrichment that used either SVF cells or ASCs, and only studies reporting volume assessment were included. A total of 38 articles (15 human and 23 animal) were included to investigate the effects of cell enrichment on graft retention as well as the feasibility and clinical relevance of cell-enriched fat grafting. Improvements in graft retention, the SVF to fat (SVF:fat) ratio, and the ASC concentration used for enrichment were emphasized. We proposed an increased retention rate greater than 1.5-fold relative to nonenriched grafts and a maximum SVF:fat ratio of 1:1 as the thresholds for clinical relevance and feasibility, respectively. Nine studies fulfilled these criteria, whereof 6 used ASCs for enrichment. We found no convincing evidence of a clinically relevant effect of SVF enrichment in humans. ASC enrichment has shown promising results in enhancing graft retention, but additional clinical trials are needed to substantiate this claim and also determine the optimal concentration of SVF cells/ASCs for enrichment. 4. © 2017 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

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

Clinic Personnel, Facilitator, and Parent Perspectives of eHealth Familias Unidas in Primary Care

PubMed Central

Molleda, Lourdes; Bahamon, Monica; St. George, Sara M.; Perrino, Tatiana; Estrada, Yannine; Herrera, Deborah Correa; Pantin, Hilda; Prado, Guillermo

2018-01-01

Introduction The purpose of this qualitative study was to understand the feasibility and acceptability of implementing eHealth Familias Unidas, an Internet-based, family-based, preventive intervention for Hispanic adolescents, in primary care. Methods Semistructured individual interviews with clinic personnel and facilitators (i.e., physicians, nurse practitioners, administrators, and mental health workers; n = 9) and one focus group with parents (n = 6) were audiorecorded, transcribed verbatim, and analyzed using a general inductive approach. Results Nine major themes emerged, including recommendations to minimize disruption to clinic flow, improve collaboration and training of clinic personnel and the research team, promote the clinic as a trusted setting for improving children’s behavioral health, and highlight the flexibility and convenience of the eHealth format. Discussion This study provides feasibility and acceptability findings, along with important considerations for researchers and primary care personnel interested in collaborating to implement an eHealth preventive intervention in pediatric primary care. PMID:28012799

Continuous Postoperative Pericardial Flushing: A Pilot Study on Safety, Feasibility, and Effect on Blood Loss

PubMed Central

Manshanden, Johan S.J.; Gielen, Chantal L.I.; de Borgie, Corianne A.J.M.; Klautz, Robert J.M.; de Mol, Bas A.J.M.; Koolbergen, David R.

2015-01-01

Background Prolonged or excessive blood loss is a common complication after cardiac surgery. Blood remnants and clots, remaining in the pericardial space in spite of chest tube drainage, induce high fibrinolytic activity that may contribute to bleeding complications. Continuous postoperative pericardial flushing (CPPF) with an irrigation solution may reduce blood loss by preventing the accumulation of clots. In this pilot study, the safety and feasibility of CPPF were evaluated and the effect on blood loss and other related complications was investigated. Methods Between November 2011 and April 2012 twenty-one adult patients undergoing surgery for congenital heart disease (CHD) received CPPF from sternal closure up to 12 h postoperative. With an inflow Redivac drain that was inserted through one of the chest tube incision holes, an irrigation solution (NaCl 0.9% at 38 °C) was delivered to the pericardial cavity using a volume controlled flushing system. Safety aspects, feasibility issues and complications were registered. The mean actual blood loss in the CPPF group was compared to the mean of a retrospective group (n = 126). Results CPPF was successfully completed in 20 (95.2%) patients, and no method related complications were observed. Feasibility was good in this experimental setting. Patients receiving CPPF showed a 30% (P = 0.038) decrease in mean actual blood loss 12 h postoperatively. Conclusions CPPF after cardiac surgery was found to be safe and feasible in this experimental setting. The clinically relevant effect on blood loss needs to be confirmed in a randomized clinical trial. PMID:26501121

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast

PubMed Central

Miller, Jessica A.; Thompson, Patricia A.; Hakim, Iman A.; Lopez, Ana Maria; Thomson, Cynthia A.; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H.-H. Sherry

2013-01-01

Background Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. Materials and Methods We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. Results The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Conclusions Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women. PMID:24236248

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

PubMed

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

2017-05-12

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

INVESTIGATE-I (INVasive Evaluation before Surgical Treatment of Incontinence Gives Added Therapeutic Effect?): study protocol for a mixed methods study to assess the feasibility of a future randomised controlled trial of the clinical utility of invasive urodynamic testing

PubMed Central

2011-01-01

Background Urinary incontinence is an important health problem to the individual sufferer and to health services. Stress and stress predominant mixed urinary incontinence are increasingly managed by surgery due to advances in surgical techniques. Despite the lack of evidence for its clinical utility, most clinicians undertake invasive urodynamic testing (IUT) to confirm a functional diagnosis of urodynamic stress incontinence before offering surgery for this condition. IUT is expensive, embarrassing and uncomfortable for women and carries a small risk. Recent systematic reviews have confirmed the lack of high quality evidence of effectiveness. The aim of this pilot study is to test the feasibility of a future definitive randomised control trial that would address whether IUT alters treatment decisions and treatment outcome in these women and would test its clinical and cost effectiveness. Methods/design This is a mixed methods pragmatic multicentre feasibility pilot study with four components:- (a) A multicentre, external pilot randomised trial comparing basic clinical assessment with non-invasive tests and IUT. The outcome measures are rates of recruitment, randomisation and data completion. Data will be used to estimate sample size necessary for the definitive trial. (b) Qualitative interviews of a purposively sampled sub-set of women eligible for the pilot trial will explore willingness to participate, be randomised and their overall trial experience. (c) A national survey of clinicians to determine their views of IUT in this context, the main outcome being their willingness to randomise patients into the definitive trial. (d) Qualitative interviews of a purposively sampled group of these clinicians will explore whether and how they use IUT to inform their decisions. Discussion The pilot trial will provide evidence of feasibility and acceptability and therefore inform the decision whether to proceed to the definitive trial. Results will inform the design and conduct of the definitive trial and ensure its effectiveness in achieving its research aim. Trial registration number Current Controlled Trials ISRCTN71327395 assigned 7th June 2010. PMID:21733166

78 FR 60291 - Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-10-01

...] Investigational Device Exemptions for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Through the...

Cognitive Behavioral Treatment of PTSD in Residents of Battered Women's Shelters: Results of a Randomized Clinical Trial

ERIC Educational Resources Information Center

Johnson, Dawn M.; Zlotnick, Caron; Perez, Sara

2011-01-01

Objective: This study was designed to explore the acceptability, feasibility, and initial efficacy of a new shelter-based treatment for victims of intimate partner violence (IPV; i.e., Helping to Overcome PTSD through Empowerment [HOPE]). Method: A Phase I randomized clinical trial comparing HOPE (n = 35) with standard shelter services (SSS) (n =…

Microcomputer Calculated Diagnostic X-Ray Exposure Factors: Clinical Evaluation

PubMed Central

Markivee, C. R.; Edwards, F. Marc; Leonard, Patricia

1981-01-01

Calculation of correct settings for the controls of a diagnostic x-ray machine was established as feasible in a microcomputer with 4K memory. The cost effectiveness and other findings in the application of this method are discussed.

Implementation of fast macromolecular proton fraction mapping on 1.5 and 3 Tesla clinical MRI scanners: preliminary experience

NASA Astrophysics Data System (ADS)

Yarnykh, V.; Korostyshevskaya, A.

2017-08-01

Macromolecular proton fraction (MPF) is a biophysical parameter describing the amount of macromolecular protons involved into magnetization exchange with water protons in tissues. MPF represents a significant interest as a magnetic resonance imaging (MRI) biomarker of myelin for clinical applications. A recent fast MPF mapping method enabled clinical translation of MPF measurements due to time-efficient acquisition based on the single-point constrained fit algorithm. However, previous MPF mapping applications utilized only 3 Tesla MRI scanners and modified pulse sequences, which are not commonly available. This study aimed to test the feasibility of MPF mapping implementation on a 1.5 Tesla clinical scanner using standard manufacturer’s sequences and compare the performance of this method between 1.5 and 3 Tesla scanners. MPF mapping was implemented on 1.5 and 3 Tesla MRI units of one manufacturer with either optimized custom-written or standard product pulse sequences. Whole-brain three-dimensional MPF maps obtained from a single volunteer were compared between field strengths and implementation options. MPF maps demonstrated similar quality at both field strengths. MPF values in segmented brain tissues and specific anatomic regions appeared in close agreement. This experiment demonstrates the feasibility of fast MPF mapping using standard sequences on 1.5 T and 3 T clinical scanners.

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.

An educational game for teaching clinical practice guidelines to Internal Medicine residents: development, feasibility and acceptability

PubMed Central

Akl, Elie A; Mustafa, Reem; Slomka, Thomas; Alawneh, Alia; Vedavalli, Abhishek; Schünemann, Holger J

2008-01-01

Background Adherence to Clinical Practice Guidelines (CPGs) remains suboptimal among internal medicine trainees. Educational games are of growing interest and have the potential to improve adherence to CPGs. The objectives of this study were to develop an educational game to teach CPGs in Internal Medicine residency programs and to evaluate its feasibility and acceptability. Methods We developed the Guide-O-Game© in the format of a TV game show with questions based on recommendations of CPGs. The development of the Guide-O-Game© consisted of the creation of a multimedia interactive tool, the development of recommendation-based questions, and the definition of the game's rules. We evaluated its feasibility through pilot testing and its acceptability through a qualitative process. Results The multimedia interactive tool uses a Macromedia Flash web application and consists of a manager interface and a user interface. The user interface allows the choice of two game styles. We created so far 16 sets of questions relating to 9 CPGs. The pilot testing proved that the game was feasible. The qualitative evaluation showed that residents considered the game to be acceptable. Conclusion We developed an educational game to teach CPGs to Internal Medicine residents that is both feasible and acceptable. Future work should evaluate its impact on educational outcomes. PMID:19017400

Autologous intravenous bone marrow mononuclear cell therapy for patients with subacute ischaemic stroke: A pilot study

PubMed Central

Prasad, Kameshwar; Mohanty, Sujata; Bhatia, Rohit; Srivastava, M.V.P.; Garg, Ajay; Srivastava, Achal; Goyal, Vinay; Tripathi, Manjari; Kumar, Amit; Bal, Chandrashekar; Vij, Aarti; Mishra, Nalini Kant

2012-01-01

Background & objectives: Bone marrow mononuclear cell therapy has emerged as one of the option for the treatment of Stroke. Several preclinical studies have shown that the treatment with mononuclear cell (MNCs) can reduce the infarct size and improve the functional outcome. We evaluated the feasibility, safety and clinical outcome of administering bone marrow mononuclear cell (MNCs) intravenously to patients with subacute ischaemic stroke. Methods: In a non-randomized phase-I clinical study, 11 consecutive, eligible and consenting patients, aged 30-70 yr with ischaemic stroke involving anterior circulation within 7 to 30 days of onset of stroke were included. Bone marrow was aspirated from iliac crest and the harvested mononuclear cells were infused into antecubital vein. Outcomes measured for safety included immediate reactions after cell infusion and evidence of tumour formation at one year in whole body PET scan. Patients were followed at week 1, 4-6, 24 and 52 to determine clinical progress using National Institute of Health Stroke Scale (NIHSS), Barthel Index (BI), modified Rankin Scale (mRS), MRI, EEG and PET. Feasibility outcomes included target-dose feasibility. Favourable clinical outcome was defined as mRS score of 2 or less or BI score of 75 to 100 at six months after stem cell therapy. Results: Between September 2006 and April 2007, 11 patients were infused with bone-marrow mononuclear cells (mean 80 million with CD-34+ mean 0.92 million). Protocol was target-dose feasible in 9 patients (82%). FDG-PET scan at 24 and 52 wk in nine patients did not reveal evidence of tumour formation. Seven patients had favourable clinical outcome. Interpretation & conclusions: Intravenous bone marrow mononuclear cell therapy appears feasible and safe in patients with subacute ischaemic stroke. Further, a randomized controlled trial to examine its efficacy is being conducted. PMID:22960888

The Feasibility of Applying PBL Teaching Method to Surgery Teaching of Chinese Medicine

ERIC Educational Resources Information Center

Tang, Qianli; Yu, Yuan; Jiang, Qiuyan; Zhang, Li; Wang, Qingjian; Huang, Mingwei

2008-01-01

The traditional classroom teaching mode is based on the content of the subject, takes the teacher as the center and gives priority to classroom instruction. While PBL (Problem Based Learning) teaching method breaches the traditional mode, combining the basic science with clinical practice and covering the process from discussion to self-study to…

Consumer health information technology in an adult public health primary care clinic: a heart health education feasibility study.

PubMed

Gleason-Comstock, Julie A; Streater, Alicia; Jen, Kai-Lin Catherine; Artinian, Nancy T; Timmins, Jessica; Baker, Suzanne; Joshua, Bosede; Paranjpe, Aniruddha

2013-12-01

To explore the feasibility and short term outcomes of using an interactive kiosk integrated into office flow to deliver health information in a primary care clinic. Fifty-one adults with BMI ≥25 were randomly assigned to use a kiosk with attached devices to receive a six-week healthy eating/weight monitoring (intervention) or general health/BP monitoring (attention-control) program. Outcomes were measured at baseline, 8 weeks (post) and three month follow-up. Participants completed an average of 2.73 weekly sessions, with transportation and time given as limiting factors. They found the kiosk easy to use (97%), liked the touchscreen (94%), and would use the kiosk again (81%). Although there were no differences between groups, the 27 completing all assessments showed reduced weight (p=.02), and decreased systolic (p=.01) and diastolic BP (p<.001) at follow-up. Although healthy eating behaviors increased, the change was not statistically significant. Using a kiosk within a clinic setting is a feasible method of providing health information and self-monitoring. Multi-session educational content can provide beneficial short-term outcomes in overweight adults. A kiosk with attached peripherals in a clinic setting is a viable adjunct to provider education, particularly in medically underserved areas. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The Feasibility and Acceptability of Using a Portfolio to Assess Professional Competence

PubMed Central

Tuekam, Rosine

2011-01-01

ABSTRACT Purpose: Little is known about physical therapists' views on the use of portfolios to evaluate professional competence. The purpose of this study was to gather the opinions of physical therapists on the feasibility and acceptability of a portfolio prepared to demonstrate evidence of clinical specialization through reported activities and accomplishments related to professional development, leadership, and research. Methods: Twenty-nine Canadian physical therapists practising in the neurosciences area were given 8 weeks to prepare a professional portfolio. Participants submitted the portfolio along with a survey addressing the preparation of the portfolio and its role as an assessment tool. Qualitative content analysis was used to interpret the participants' comments. Results: Participants reported that maintaining organized records facilitated the preparation of their portfolio. They experienced pride when reviewing their completed portfolios, which summarized their professional activities and highlighted their achievements. Concerns were noted about the veracity of self-reported records and the ability of the documentation to provide a comprehensive view of the full scope of the professional competencies required for clinical specialization (e.g., clinical skills). Conclusion: The study's findings support the feasibility and acceptability of a portfolio review to assess professional competence and clinical specialization in physical therapy and have implications for both physical therapists and professional agencies. PMID:22210983

Benchmarking Distance Control and Virtual Drilling for Lateral Skull Base Surgery.

PubMed

Voormolen, Eduard H J; Diederen, Sander; van Stralen, Marijn; Woerdeman, Peter A; Noordmans, Herke Jan; Viergever, Max A; Regli, Luca; Robe, Pierre A; Berkelbach van der Sprenkel, Jan Willem

2018-01-01

Novel audiovisual feedback methods were developed to improve image guidance during skull base surgery by providing audiovisual warnings when the drill tip enters a protective perimeter set at a distance around anatomic structures ("distance control") and visualizing bone drilling ("virtual drilling"). To benchmark the drill damage risk reduction provided by distance control, to quantify the accuracy of virtual drilling, and to investigate whether the proposed feedback methods are clinically feasible. In a simulated surgical scenario using human cadavers, 12 unexperienced users (medical students) drilled 12 mastoidectomies. Users were divided into a control group using standard image guidance and 3 groups using distance control with protective perimeters of 1, 2, or 3 mm. Damage to critical structures (sigmoid sinus, semicircular canals, facial nerve) was assessed. Neurosurgeons performed another 6 mastoidectomy/trans-labyrinthine and retro-labyrinthine approaches. Virtual errors as compared with real postoperative drill cavities were calculated. In a clinical setting, 3 patients received lateral skull base surgery with the proposed feedback methods. Users drilling with distance control protective perimeters of 3 mm did not damage structures, whereas the groups using smaller protective perimeters and the control group injured structures. Virtual drilling maximum cavity underestimations and overestimations were 2.8 ± 0.1 and 3.3 ± 0.4 mm, respectively. Feedback methods functioned properly in the clinical setting. Distance control reduced the risks of drill damage proportional to the protective perimeter distance. Errors in virtual drilling reflect spatial errors of the image guidance system. These feedback methods are clinically feasible. Copyright © 2017 Elsevier Inc. All rights reserved.

Feasibility and Acceptability of Smartphone Assessment in Older Adults with Cognitive and Emotional Difficulties

PubMed Central

Ramsey, Alex T.; Wetherell, Julie Loebach; Depp, Colin; Dixon, David; Lenze, Eric

2016-01-01

Objectives Ecological momentary assessment (EMA) has several advantages in clinical research yet little is known about the feasibility of collecting EMA data with mobile technologies in older adults, particularly those with emotional or cognitive difficulties. The aim of this feasibility study was to assess perceived acceptability, adherence rates, and reasons for non-adherence to smartphone-based EMA. Method At two sites, participants (n=103) aged 65 years or older with a DSM-IV-defined anxiety or depressive disorder and cognitive concerns responded three times daily to smartphone-based EMA questions assessing clinical outcomes for two 10-day periods. Quantitative and qualitative measures assessed acceptability, adherence, and reasons for non-adherence following both 10-day EMA periods. Results Participants were moderately satisfied with and comfortable using smartphone-based EMA. Overall, 76% of participants completed surveys on ≥10 of the 20 assessment days, and 70% of participants completed at least 30% of the total surveys. Reasons for non-adherence included technical (malfunction), logistical (competing demands), physiological (hearing difficulties), and cognitive (forgetting) issues. Discussion Smartphone-based EMA is feasible in older adults with cognitive and emotional difficulties. EMA tools should be responsive to the needs and preferences of participants to ensure adequate acceptability and adherence in this population. Our findings can inform the design, development, and implementation of mobile technologies in older adults in research and clinical contexts. PMID:27683018

Clinical feasibility of simultaneous multi-slice imaging with blipped-CAIPI for diffusion-weighted imaging and diffusion-tensor imaging of the brain.

PubMed

Yokota, Hajime; Sakai, Koji; Tazoe, Jun; Goto, Mariko; Imai, Hiroshi; Teramukai, Satoshi; Yamada, Kei

2017-12-01

Background Simultaneous multi-slice (SMS) imaging is starting to be used in clinical situation, although evidence of clinical feasibility is scanty. Purpose To prospectively assess the clinical feasibility of SMS diffusion-weighted imaging (DWI) and diffusion-tensor imaging (DTI) with blipped-controlled aliasing in parallel imaging for brain lesions. Material and Methods The institutional review board approved this study. This study included 156 hyperintense lesions on DWI from 32 patients. A slice acceleration factor of 2 was applied for SMS scans, which allowed shortening of the scan time by 41.3%. The signal-to-noise ratio (SNR) was calculated for brain tissue of a selected slice. The contrast-to-noise ratio (CNR), apparent diffusion coefficient (ADC), and fractional anisotropy (FA) were calculated in 36 hyperintense lesions with a diameter of three pixels or more. Visual assessment was performed for all 156 lesions. Tractography of the corticospinal tract of 29 patients was evaluated. The number of tracts and averaged tract length were used for quantitative analysis, and visual assessment was evaluated by grading. Results The SMS scan showed no bias and acceptable 95% limits of agreement compared to conventional scans in SNR, CNR, and ADC on Bland-Altman analyses. Only FA of the lesions was higher in the SMS scan by 9% ( P = 0.016), whereas FA of the surrounding tissues was similar. Quantitative analysis of tractography showed similar values. Visual assessment of DWI hyperintense lesions and tractography also resulted in comparable evaluation. Conclusion SMS imaging was clinically feasible for imaging quality and quantitative values compared with conventional DWI and DTI.

Using routinely recorded data in the UK to assess outcomes in a randomised controlled trial: The Trials of Access.

PubMed

Powell, G A; Bonnett, L J; Tudur-Smith, C; Hughes, D A; Williamson, P R; Marson, A G

2017-08-23

In the UK, routinely recorded data may benefit prospective studies including randomised controlled trials (RCTs). In an on-going study, we aim to assess the feasibility of access and agreement of routinely recorded clinical and non-clinical data compared to data collected during a RCT using standard prospective methods. This paper will summarise available UK routinely recorded data sources and discuss our experience with the feasibility of accessing routinely recorded data for participants of a RCT before finally proposing recommendations for improving the access and implementation of routinely recorded data in RCTs. Setting: the case study RCT is the Standard and New Antiepileptic Drugs II (SANAD II) trial, a pragmatic, UK, multicentre, phase IV RCT assessing the clinical and cost-effectiveness of antiepileptic drug treatments for newly diagnosed epilepsy. 98 participants have provided written consent to permit the request of routinely recorded data. Study procedures: routinely recorded clinical and non-clinical data were identified and data requested through formal applications from available data holders for the duration that participants have been recruited into SANAD II. The feasibility of accessing routinely recorded data during a RCT is assessed and recommendations for improving access proposed. Secondary-care clinical and socioeconomic data is recorded on a national basis and can be accessed, although there are limitations in the application process. Primary-care data are recorded by a number of organisations on a de-identified basis but access for specific individuals has not been feasible. Access to data recorded by non-clinical sources, including The Department for Work and Pensions and The Driving and Vehicle Licensing Agency, was not successful. Recommendations discussed include further research to assess the attributes of routinely recorded data, an assessment of public perceptions and the development of strategies to collaboratively improve access to routinely recorded data for research. International Standard Randomised Controlled Trials, ISRCTN30294119 . Registered on 3 July 2012. EudraCT No: 2012-001884-64. Registered on 9 May 2012.

Portable fluorescence lifetime spectroscopy system for in-situ interrogation of biological tissues

NASA Astrophysics Data System (ADS)

Saito Nogueira, Marcelo; Cosci, Alessandro; Teixeira Rosa, Ramon Gabriel; Salvio, Ana Gabriela; Pratavieira, Sebastião; Kurachi, Cristina

2017-12-01

Fluorescence spectroscopy and lifetime techniques are potential methods for optical diagnosis and characterization of biological tissues with an in-situ, fast, and noninvasive interrogation. Several diseases may be diagnosed due to differences in the fluorescence spectra of targeted fluorophores, when, these spectra are similar, considering steady-state fluorescence, others may be detected by monitoring their fluorescence lifetime. Despite this complementarity, most of the current fluorescence lifetime systems are not robust and portable, and not being feasible for clinical applications. We describe the assembly of a fluorescence lifetime spectroscopy system in a suitcase, its characterization, and validation with clinical measurements of skin lesions. The assembled system is all encased and robust, maintaining its mechanical, electrical, and optical stability during transportation, and is feasible for clinical measurements. The instrument response function measured was about 300 ps, and the system is properly calibrated. At the clinical study, the system showed to be reliable, and the achieved spectroscopy results support its potential use as an auxiliary tool for skin diagnostics.

A Pilot Study of Parent Mentors for Early Childhood Obesity.

PubMed

Foster, Byron A; Aquino, Christian A; Gil, Mario; Gelfond, Jonathan A L; Hale, Daniel E

2016-01-01

Objective. To assess the feasibility of a parent mentor model of intervention for early childhood obesity using positive deviance-based methods to inform the intervention. Methods. In this pilot, randomized clinical trial, parent-child dyads (age: 2-5) with children whose body mass index (BMI) was ≥95th percentile were randomized to parent mentor intervention or community health worker comparison. The child's height and weight were measured at baseline, after the six-month intervention, and six months after the intervention. Feasibility outcomes were recruitment, participation, and retention. The primary clinical outcome was BMI z-score change. Results. Sixty participants were enrolled, and forty-eight completed the six-month intervention. At baseline, the BMI z-score in the parent mentor group was 2.63 (SD = 0.65) and in the community health worker group it was 2.61 (SD = 0.89). For change in BMI z-score over time, there was no difference by randomization group at the end of the intervention: -0.02 (95% CI: -0.26, 0.22). At the end of the intervention, the BMI z-score for the parent mentor group was 2.48 (SD = 0.58) and for the community health worker group it was 2.45 (SD = 0.91), both reduced from baseline, p < 0.001. Conclusion. The model of a parent mentor clinical trial is feasible, and both randomized groups experienced small, sustained effects on adiposity in an obese, Hispanic population.

The feasibility of community level interventions for pre-eclampsia in South Asia and Sub-Saharan Africa: a mixed-methods design.

PubMed

Khowaja, Asif Raza; Qureshi, Rahat Najam; Sawchuck, Diane; Oladapo, Olufemi T; Adetoro, Olalekan O; Orenuga, Elizabeth A; Bellad, Mrutyunjaya; Mallapur, Ashalata; Charantimath, Umesh; Sevene, Esperança; Munguambe, Khátia; Boene, Helena Edith; Vidler, Marianne; Bhutta, Zulfiqar A; von Dadelszen, Peter

2016-06-08

Globally, pre-eclampsia and eclampsia are major contributors to maternal and perinatal mortality; of which the vast majority of deaths occur in less developed countries. In addition, a disproportionate number of morbidities and mortalities occur due to delayed access to health services. The Community Level Interventions for Pre-eclampsia (CLIP) Trial aims to task-shift to community health workers the identification and emergency management of pre-eclampsia and eclampsia to improve access and timely care. Literature revealed paucity of published feasibility assessments prior to initiating large-scale community-based interventions. Arguably, well-conducted feasibility studies can provide valuable information about the potential success of clinical trials prior to implementation. Failure to fully understand the study context risks the effective implementation of the intervention and limits the likelihood of post-trial scale-up. Therefore, it was imperative to conduct community-level feasibility assessments for a trial of this magnitude. A mixed methods design guided by normalization process theory was used for this study in Nigeria, Mozambique, Pakistan, and India to explore enabling and impeding factors for the CLIP Trial implementation. Qualitative data were collected through participant observation, document review, focus group discussion and in-depth interviews with diverse groups of community members, key informants at community level, healthcare providers, and policy makers. Quantitative data were collected through health facility assessments, self-administered community health worker surveys, and household demographic and health surveillance. Refer to CLIP Trial feasibility publications in the current and/or forthcoming supplement. Feasibility assessments for community level interventions, particularly those involving task-shifting across diverse regions, require an appropriate theoretical framework and careful selection of research methods. The use of qualitative and quantitative methods increased the data richness to better understand the community contexts. NCT01911494.

Pilot study on the feasibility of a computerized speech recognition charting system.

PubMed

Feldman, C A; Stevens, D

1990-08-01

The objective of this study was to determine the feasibility of developing and using a voice recognition computerized charting system to record dental clinical examination data. More specifically, the study was designed to analyze the time and error differential between the traditional examiner/recorder method (ASSISTANT) and computerized voice recognition method (VOICE). DMFS examinations were performed twice on 20 patients using the traditional ASSISTANT and the VOICE charting system. A statistically significant difference was found when comparing the mean ASSISTANT time of 2.69 min to the VOICE time of 3.72 min (P less than 0.001). No statistically significant difference was found when comparing the mean ASSISTANT recording errors of 0.1 to VOICE recording errors of 0.6 (P = 0.059). 90% of the patients indicated they felt comfortable with the dentist talking to a computer and only 5% of the sample indicated they opposed VOICE. Results from this pilot study indicate that a charting system utilizing voice recognition technology could be considered a viable alternative to traditional examiner/recorder methods of clinical charting.

Novel Arch Bar Fabricated With a Computer-Aided Design and Three-Dimensional Printing: A Feasibility Study.

PubMed

He, Wei; Sun, Yuchun; Tian, Kaiyue; Xie, Xiaoyan; Wang, Xiaoxia; Li, Zili

2015-11-01

The aim of the present study was to evaluate the feasibility of the design and fabrication of a novel arch bar using 3-dimensional printing. Furthermore, the study assessed its use in a preliminary clinical study of intermaxillary fixation. Seven patients who met the inclusion criteria were enrolled in the present study. Plaster dental casts were created of each patient and scanned using cone-beam computed tomography to obtain digital casts. Computer-aided design software was then used to complete the virtual building of the arch bars, which were manufactured using 3-dimensional printing and a cobalt-chrome alloy. The clinical results were observed after the arch bars were fixed to the dentition with steel wires. The arch bar contacted the dentition with a "surface-to-surface" pattern. The utility of these novel arch bars was verified by successfully fitting them to the dental arches of the patients. All the patients achieved their desired occlusion. The results of the present study have illustrated that this digital method is feasible for constructing a novel arch bar, showing promise for clinical use. Copyright © 2015 American Association of Oral and Maxillofacial Surgeons. Published by Elsevier Inc. All rights reserved.

Multidisciplinary ALS Telemedicine Care: The Store and Forward Method.

PubMed

Pulley, Michael T; Brittain, Rebecca; Hodges, Wayne; Frazier, Christine; Miller, Leslie; Matyjasik-Liggett, Maria; Maurer, Susan; Peters, Melissa; Solomon, Kimberly; Berger, Alan R

2018-05-26

ALS patients benefit from multidisciplinary care in an ALS clinic. We studied whether multidisciplinary care of ALS patients using the store and forward method of telemedicine was feasible and acceptable to patients and providers. ALS patients seen in the UF Jacksonville ALS clinic were eligible. A trained telemedicine nurse performed and recorded a multidisciplinary assessment of the patient in their home. Clinic team members reviewed the assessments, provided recommendations and the clinic director discussed the plan with the patient via videoconference. Patient and provider satisfaction was evaluated using surveys. 18 patients completed a total of 27 telemedicine visits. Patient satisfaction was excellent and provider satisfaction was very good. The store and forward method of telemedicine is an acceptable alternative to live telemedicine for the multidisciplinary care of ALS patients. This method of care may improve access to multidisciplinary care for this patient population. This article is protected by copyright. All rights reserved. © 2018 Wiley Periodicals, Inc.

The Ronnie Gardiner Rhythm and Music Method - a feasibility study in Parkinson's disease.

PubMed

Pohl, Petra; Dizdar, Nil; Hallert, Eva

2013-01-01

To assess the feasibility of the novel intervention, Ronnie Gardiner Rhythm and Music (RGRM™) Method compared to a control group for patients with Parkinson's disease (PD). Eighteen patients, mean age 68, participating in a disability study within a neurological rehabilitation centre, were randomly allocated to intervention group (n = 12) or control group (n = 6). Feasibility was assessed by comparing effects of the intervention on clinical outcome measures (primary outcome: mobility as assessed by two-dimensional motion analysis, secondary outcomes: mobility, cognition, quality of life, adherence, adverse events and eligibility). Univariable analyses showed no significant differences between groups following intervention. However, analyses suggested that patients in the intervention group improved more on mobility (p = 0.006), cognition and quality of life than patients in the control group. There were no adverse events and a high level of adherence to therapy was observed. In this disability study, the use of the RGRM™ Method showed promising results in the intervention group and the adherence level was high. Our results suggest that most assessments chosen are eligible to use in a larger randomized controlled study for patients with PD. The RGRM™ Method appeared to be a useful and safe method that showed promising results in both motor and cognitive functions as well as quality of life in patients with moderate PD. The RGRM™ Method can be used by physiotherapists, occupational, speech and music therapists in neurological rehabilitation. Most measurements were feasible except for Timed-Up-and-Go.

Calibration of Clinical Audio Recording and Analysis Systems for Sound Intensity Measurement.

PubMed

Maryn, Youri; Zarowski, Andrzej

2015-11-01

Sound intensity is an important acoustic feature of voice/speech signals. Yet recordings are performed with different microphone, amplifier, and computer configurations, and it is therefore crucial to calibrate sound intensity measures of clinical audio recording and analysis systems on the basis of output of a sound-level meter. This study was designed to evaluate feasibility, validity, and accuracy of calibration methods, including audiometric speech noise signals and human voice signals under typical speech conditions. Calibration consisted of 3 comparisons between data from 29 measurement microphone-and-computer systems and data from the sound-level meter: signal-specific comparison with audiometric speech noise at 5 levels, signal-specific comparison with natural voice at 3 levels, and cross-signal comparison with natural voice at 3 levels. Intensity measures from recording systems were then linearly converted into calibrated data on the basis of these comparisons, and validity and accuracy of calibrated sound intensity were investigated. Very strong correlations and quasisimilarity were found between calibrated data and sound-level meter data across calibration methods and recording systems. Calibration of clinical sound intensity measures according to this method is feasible, valid, accurate, and representative for a heterogeneous set of microphones and data acquisition systems in real-life circumstances with distinct noise contexts.

Effectiveness of a Psychoeducational Parenting Group on Child, Parent and Family Behavior: A Pilot Study in a Family Practice Clinic with an Underserved Population

PubMed Central

Berge, Jerica M.; Law, David D.; Johnson, Jennifer; Wells, M. Gawain

2013-01-01

Background Although integrated care for adults in primary care has steadily increased over the last several decades, there remains a paucity of research regarding integrated care for children in primary care. Purpose To report results of a pilot study testing initial feasibility of a parenting psychoeducational group targeting child behavioral problems within a primary care clinic. Method The participants (n = 35) were parents representing an underserved population from an inner-city primary care clinic. Participants attended a 12-week psychoeducational parenting group and reported pre- and post-measures of family functioning, child misbehavior and dyadic functioning. Paired t-tests and effects sizes are reported. Results Participants reported statistically significant improvement in family functioning, child misbehavior and couple functioning after participating in the parenting psychoeducational group. Conclusions Results suggest initial feasibility of a parenting psychoeducational group within a primary care clinic with an underserved population. This intervention may be useful for other primary care clinics seeking to offer more integrative care options for children and their families. PMID:20939627

Sternal instability measured with radiostereometric analysis. A study of method feasibility, accuracy and precision.

PubMed

Vestergaard, Rikke Falsig; Søballe, Kjeld; Hasenkam, John Michael; Stilling, Maiken

2018-05-18

A small, but unstable, saw-gap may hinder bone-bridging and induce development of painful sternal dehiscence. We propose the use of Radiostereometric Analysis (RSA) for evaluation of sternal instability and present a method validation. Four bone analogs (phantoms) were sternotomized and tantalum beads were inserted in each half. The models were reunited with wire cerclage and placed in a radiolucent separation device. Stereoradiographs (n = 48) of the phantoms in 3 positions were recorded at 4 imposed separation points. The accuracy and precision was compared statistically and presented as translations along the 3 orthogonal axes. 7 sternotomized patients were evaluated for clinical RSA precision by double-examination stereoradiographs (n = 28). In the phantom study, we found no systematic error (p > 0.3) between the three phantom positions, and precision for evaluation of sternal separation was 0.02 mm. Phantom accuracy was mean 0.13 mm (SD 0.25). In the clinical study, we found a detection limit of 0.42 mm for sternal separation and of 2 mm for anterior-posterior dislocation of the sternal halves for the individual patient. RSA is a precise and low-dose image modality feasible for clinical evaluation of sternal stability in research. ClinicalTrials.gov Identifier: NCT02738437 , retrospectively registered.

A Place-Based Community Health Worker Program: Feasibility and Early Outcomes, New York City, 2015

PubMed Central

Lopez, Priscilla M.; Islam, Nadia; Feinberg, Alexis; Myers, Christa; Seidl, Lois; Drackett, Elizabeth; Riley, Lindsey; Mata, Andrea; Pinzon, Juan; Benjamin, Elisabeth; Wyka, Katarzyna; Dannefer, Rachel; Lopez, Javier; Trinh-Shevrin, Chau; Maybank, Karen Aletha; Thorpe, Lorna E.

2017-01-01

Introduction This study examined feasibility of a place-based community health worker (CHW) and health advocate (HA) initiative in five public housing developments selected for high chronic disease burden and described early outcomes. Methods This intervention was informed by a mixed-method needs assessment performed December 2014–January 2015 (representative telephone survey, n=1,663; six focus groups, n=55). Evaluation design was a non-randomized, controlled quasi-experiment. Intake and 3-month follow-up data were collected February–December 2015 (follow-up response rate, 93%) on 224 intervention and 176 comparison participants, and analyzed in 2016. All participants self-reported diagnoses of hypertension, diabetes, or asthma. The intervention consisted of chronic disease self-management and goal setting through six individual CHW-led health coaching sessions, instrumental support, and facilitated access to insurance/clinical care navigation from community-based HAs. Feasibility measures included CHW service satisfaction and successful goal setting. Preliminary outcomes included clinical measures (blood pressure, BMI); disease management behaviors and self-efficacy; and preventive behaviors (physical activity). Results At the 3-month follow-up, nearly all intervention participants reported high satisfaction with their CHW (90%) and HA (76%). Intervention participants showed significant improvements in self-reported physical activity (p=0.005) and, among hypertensive participants, self-reported routine blood pressure self-monitoring (p=0.013) compared with comparison participants. No improvements were observed in self-efficacy or clinical measures at the 3-month follow-up. Conclusions Housing-based initiatives involving CHW and HA teams are acceptable to public housing residents and can be effectively implemented to achieve rapid improvements in physical activity and chronic disease self-management. At 3-month assessment, additional time and efforts are required to improve clinical outcomes. PMID:28215382

Feasibility of a Clinical Trial of Vision Therapy for Treatment of Amblyopia

PubMed Central

Lyon, Don W.; Hopkins, Kristine; Chu, Raymond H.; Tamkins, Susanna M.; Cotter, Susan A.; Melia, B. Michele; Holmes, Jonathan M.; Repka, Michael X.; Wheeler, David T.; Sala, Nicholas A.; Dumas, Janette; Silbert, David I.

2013-01-01

Purpose We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. Methods A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, 7 to less than 13 years of age, with amblyopia (20/40–20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Results Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. Conclusions This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis, might be required to allow enrollment of a broader group of subjects. PMID:23563444

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study

PubMed Central

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

Background There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. Methods The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Discussion Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation. PMID:29950816

The feasibility and concurrent validity of performing the Movement Assessment Battery for Children - 2nd Edition via telerehabilitation technology.

PubMed

Nicola, Kristy; Waugh, Jemimah; Charles, Emily; Russell, Trevor

2018-06-01

In rural and remote communities children with motor difficulties have less access to rehabilitation services. Telerehabilitation technology is a potential method to overcome barriers restricting access to healthcare in these areas. Assessment is necessary to guide clinical reasoning; however it is unclear which paediatric assessments can be administered remotely. The Movement Assessment Battery for Children - 2nd Edition is commonly used by various health professionals to assess motor performance of children. The aim of this study was to investigate the feasibility and concurrent validity of performing the Movement Assessment Battery for Children - 2nd Edition remotely via telerehabilitation technology compared to the conventional in-person method. Fifty-nine children enrolled in a state school (5-11 years old) volunteered to perform one in-person and one telerehabilitation mediated assessment. The order of the method of delivery and the therapist performing the assessment were randomized. After both assessments were complete, a participant satisfaction questionnaire was completed by each child. The Bland-Altman limits of agreement for the total test standard score were -3.15 to 3.22 which is smaller than a pre-determined clinically acceptable margin based on the smallest detectable change. This study establishes the feasibility and concurrent validity of the administration of the Movement Assessment Battery for Children - 2nd Edition via telerehabilitation technology. Overall, participants perceived their experience with telerehabilitation positively. Copyright © 2018 Elsevier Ltd. All rights reserved.

A Contingency Management Intervention for Adolescent Marijuana Abuse and Conduct Problems.

ERIC Educational Resources Information Center

Kamon, Jody; Budney, Alan; Stanger, Catherine

2005-01-01

Objective: To describe an innovative treatment for adolescent marijuana abuse and provide initial information about its feasibility, acceptability, and potential efficacy. Method: Provided an intervention composed of (1) a clinic-administered, abstinence-based incentive program; (2) parent-directed contingency management targeting substance use…

Enrollees Choose Priorities for Medicare

ERIC Educational Resources Information Center

Danis, Marion; Biddle, Andrea K.; Goold, Susan Dorr

2004-01-01

Purpose: The purpose of this study was to demonstrate the feasibility and results of ascertaining Medicare enrollees' priorities for insured medical benefits. Design and Methods: Structured group exercises were conducted with Medicare enrollees from clinical and community settings in central North Carolina. By participating in a decision exercise,…

Intake assessment of problematic use of medications in a chronic noncancer pain clinic

PubMed Central

Pink, Leah R; Smith, Andrew J; Peng, Philip WH; Galonski, Marilyn J; Tumber, Paul S; Evans, David; Gourlay, Doug L; Gordon, Lesley; Bellingham, Geoff A; Nijjar, Satnam S; Picard, Larry M; Gordon, Allan S

2012-01-01

BACKGROUND: The present article outlines the process of instituting an assessment of risk of problematic use of medications with new patients in an ambulatory chronic noncancer pain (CNCP) clinic. It is hoped that the authors’ experience through this iterative process will fill the gap in the literature by setting an example of an application of the ‘universal precautions’ approach to chronic pain management. OBJECTIVES: To assess the feasibility and utility of the addition of a new risk assessment process and to provide a snapshot of the risk of problematic use of medications in new patients presenting to a tertiary ambulatory clinic treating CNCP. METHODS: Charts for the first three months following the institution of an intake assessment for risk of problematic medication use were reviewed. Health care providers at the Wasser Pain Management Centre (Toronto, Ontario) were interviewed to discuss the preliminary findings and provide feedback about barriers to completing the intake assessments, as well as to identify the items that were clinically relevant and useful to their practice. RESULTS: Data were analyzed and examined for completeness. While some measures were considered to be particularly helpful, other items were regarded as repetitive, problematic or time consuming. Feedback was then incorporated into revisions of the risk assessment tool. DISCUSSION: Overall, it is feasible and useful to assess risk for problematic use of medications in new patients presenting to CNCP clinics. CONCLUSION: To facilitate the practice of assessment, the risk assessment tool at intake must be concise, clinically relevant and feasible given practitioner time constraints. PMID:22891193

The use of feasibility studies for stepped-wedge cluster randomised trials: protocol for a review of impact and scope

PubMed Central

Kristunas, Caroline A; Hemming, Karla; Eborall, Helen C; Gray, Laura J

2017-01-01

Introduction The stepped-wedge cluster randomised trial (SW-CRT) is a complex design, for which many decisions about key design parameters must be made during the planning. These include the number of steps and the duration of time needed to embed the intervention. Feasibility studies are likely to be useful for informing these decisions and increasing the likelihood of the main trial's success. However, the number of feasibility studies being conducted for SW-CRTs is currently unknown. This review aims to establish the number of feasibility studies being conducted for SW-CRTs and determine which feasibility issues are commonly investigated. Methods and analysis Fully published feasibility studies for SW-CRTs will be identified, according to predefined inclusion criteria, from searches conducted in Ovid MEDLINE, Scopus, Embase and PsycINFO. To also identify and gain information on unpublished feasibility studies the following will be contacted: authors of published SW-CRTs (identified from the most recent systematic reviews); contacts for registered SW-CRTs (identified from clinical trials registries); lead statisticians of UK registered clinical trials units and researchers known to work in the area of SW-CRTs. Data extraction will be conducted independently by two reviewers. For the fully published feasibility studies, data will be extracted on the study characteristics, the rationale for the study, the process for determining progression to a main trial, how the study informed the main trial and whether the main trial went ahead. The researchers involved in the unpublished feasibility studies will be contacted to elicit the same information. A narrative synthesis will be conducted and provided alongside a descriptive analysis of the study characteristics. Ethics and dissemination This review does not require ethical approval, as no individual patient data will be used. The results of this review will be published in an open-access peer-reviewed journal. PMID:28765139

Left ventricular fluid mechanics: the long way from theoretical models to clinical applications.

PubMed

Pedrizzetti, Gianni; Domenichini, Federico

2015-01-01

The flow inside the left ventricle is characterized by the formation of vortices that smoothly accompany blood from the mitral inlet to the aortic outlet. Computational fluid dynamics permitted to shed some light on the fundamental processes involved with vortex motion. More recently, patient-specific numerical simulations are becoming an increasingly feasible tool that can be integrated with the developing imaging technologies. The existing computational methods are reviewed in the perspective of their potential role as a novel aid for advanced clinical analysis. The current results obtained by simulation methods either alone or in combination with medical imaging are summarized. Open problems are highlighted and perspective clinical applications are discussed.

Assessment of Solid Cancer Treatment Feasibility in Older Patients: A Prospective Cohort Study

PubMed Central

Laurent, Marie; Paillaud, Elena; Tournigand, Christophe; Caillet, Philippe; Le Thuaut, Aurélie; Lagrange, Jean-Léon; Beauchet, Olivier; Vincent, Hélène; Carvahlo-Verlinde, Muriel; Culine, Stéphane; Bastuji-Garin, Sylvie

2014-01-01

Purpose. To assess solid cancer treatment feasibility in older patients Methods. Between 2007 and 2010, 385 consecutive elderly patients (mean age: 78.9 ± 5.4 years; 47.8% males) with solid malignancies referred to two geriatric oncology clinics were included prospectively. We recorded feasibility of first-line chemotherapy (planned number of cycles in patients without metastases and three to six cycles depending on tumor site in patients with metastases), surgery (patient alive 30 days after successfully performed planned surgical procedure), radiotherapy (planned dose delivered), and hormonal therapy (planned drug dose given), and we recorded overall 1-year survival. Results. Main tumor sites were colorectal (28.6%), breast (23.1%), and prostate (10.9%), and 47% of patients had metastases. Planned cancer treatment was feasible in 65.7% of patients with metastases; this proportion was 59.0% for chemotherapy, 82.6% for surgery, 100% for radiotherapy, and 85.2% for hormonal therapy. In the group without metastases, feasibility proportions were 86.8% overall, 72.4% for chemotherapy, 95.7% for surgery, 96.4% for radiotherapy, and 97.9% for hormonal therapy. Factors independently associated with chemotherapy feasibility were good functional status defined as Eastern Cooperative Oncology Group performance status <2 (p < .0001) or activities of daily living >5 (p = .01), normal mobility defined as no difficulty walking (p = .01) or no fall risk (p = .007), and higher creatinine clearance (p = .04). Conclusion. Feasibility rates were considerably lower for chemotherapy than for surgery, radiotherapy, and hormonal therapy. Therefore, utilization of limited geriatric oncology resources may be optimized by preferential referral of elderly cancer patients initially considered for chemotherapy to geriatric oncology clinics. PMID:24569945

The Group Objective Structured Clinical Experience: building communication skills in the clinical reasoning context.

PubMed

Konopasek, Lyuba; Kelly, Kevin V; Bylund, Carma L; Wenderoth, Suzanne; Storey-Johnson, Carol

2014-07-01

Students are rarely taught communication skills in the context of clinical reasoning training. The purpose of this project was to combine the teaching of communication skills using SPs with clinical reasoning exercises in a Group Objective Structured Clinical Experience (GOSCE) to study feasibility of the approach, the effect on learners' self-efficacy and attitude toward learning communication skills, and the effect of providing multiple sources of immediate, collaborative feedback. GOSCE sessions were piloted in Pediatrics and Medicine clerkships with students assessing their own performance and receiving formative feedback on communication skills from peers, standardized patients (SPs), and faculty. The sessions were evaluated using a retrospective pre/post-training questionnaire rating changes in self-efficacy and attitudes, and the value of the feedback. Results indicate a positive impact on attitudes toward learning communication skills and self-efficacy regarding communication in the clinical setting. Also, learners considered feedback by peers, SPs, and faculty valuable in each GOSCE. The GOSCE is an efficient and learner-centered method to attend to multiple goals of teaching communication skills, clinical reasoning, self-assessment, and giving feedback in a formative setting. The GOSCE is a low-resource, feasible strategy for experiential learning in communication skills and clinical reasoning. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Primary care spirometry: test quality and the feasibility and usefulness of specialist reporting

PubMed Central

White, Patrick; Wong, Wun; Fleming, Tracey; Gray, Barry

2007-01-01

Background Provision of spirometry for chronic obstructive pulmonary disease (COPD) is a new requirement in primary care. Effective spirometry requires that tests and interpretations meet international criteria. Aim To assess the feasibility and usefulness of remote specialist reporting of primary care spirometry. Design of study Comparison of reporting by primary care clinicians and respiratory specialists of consecutive primary care spirometry tests. Setting South London primary care teams with patient lists ≥6000. Method Feasibility of remote reporting of spirometry was assessed by the frequency of electronic mailing of tests. Usefulness of remote reporting was defined by the frequency that specialist reports made a clinically significant addition. Usefulness was assessed by measuring agreement (κ) between primary care reports and those of specialists. Clinically significant disagreements were analysed with respect to test quality, diagnosis, and severity. Results Six practices emailed 312 tests over 3 months. Forty-nine tests sent without indices or curves (flow volume and time volume) were excluded. Mean age of patients tested was 65 years and 52% were female. Mean predicted forced expiratory volume in the first second (FEV1) was 69%. Clinically significant disagreements were identified in the interpretation of acceptability (quality) of 67/212 (32%) tests (κ = 0.07; 95% confidence interval [CI] = 0 to 0.24), of diagnosis in 49/168 (29%) tests (κ = 0.39; 95% CI = 0.25 to 0.55), and of severity in 62/191 (32%) tests (κ = 0.53; 95% CI = 0.43 to 0.63). Conclusion Remote reporting of primary care spirometry was feasible. Its usefulness was confirmed by the high rate of additional clinically significant information to the reports of primary care clinicians. The quality of primary care spirometry was so unsatisfactory that remote reporting of tests may be a means of establishing adequate spirometry. PMID:17761057

A Serious Game for Clinical Assessment of Cognitive Status: Validation Study.

PubMed

Tong, Tiffany; Chignell, Mark; Tierney, Mary C; Lee, Jacques

2016-05-27

We propose the use of serious games to screen for abnormal cognitive status in situations where it may be too costly or impractical to use standard cognitive assessments (eg, emergency departments). If validated, serious games in health care could enable broader availability of efficient and engaging cognitive screening. The objective of this work is to demonstrate the feasibility of a game-based cognitive assessment delivered on tablet technology to a clinical sample and to conduct preliminary validation against standard mental status tools commonly used in elderly populations. We carried out a feasibility study in a hospital emergency department to evaluate the use of a serious game by elderly adults (N=146; age: mean 80.59, SD 6.00, range 70-94 years). We correlated game performance against a number of standard assessments, including the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and the Confusion Assessment Method (CAM). After a series of modifications, the game could be used by a wide range of elderly patients in the emergency department demonstrating its feasibility for use with these users. Of 146 patients, 141 (96.6%) consented to participate and played our serious game. Refusals to play the game were typically due to concerns of family members rather than unwillingness of the patient to play the game. Performance on the serious game correlated significantly with the MoCA (r=-.339, P <.001) and MMSE (r=-.558, P <.001), and correlated (point-biserial correlation) with the CAM (r=.565, P <.001) and with other cognitive assessments. This research demonstrates the feasibility of using serious games in a clinical setting. Further research is required to demonstrate the validity and reliability of game-based assessments for clinical decision making.

Novel methods to estimate antiretroviral adherence: protocol for a longitudinal study.

PubMed

Saberi, Parya; Ming, Kristin; Legnitto, Dominique; Neilands, Torsten B; Gandhi, Monica; Johnson, Mallory O

2018-01-01

There is currently no gold standard for assessing antiretroviral (ARV) adherence, so researchers often resort to the most feasible and cost-effective methods possible (eg, self-report), which may be biased or inaccurate. The goal of our study was to evaluate the feasibility and acceptability of innovative and remote methods to estimate ARV adherence, which can potentially be conducted with less time and financial resources in a wide range of clinic and research settings. Here, we describe the research protocol for studying these novel methods and some lessons learned. The 6-month pilot study aimed to examine the feasibility and acceptability of a remotely conducted study to evaluate the correlation between: 1) text-messaged photographs of pharmacy refill dates for refill-based adherence; 2) text-messaged photographs of pills for pill count-based adherence; and 3) home-collected hair sample measures of ARV concentration for pharmacologic-based adherence. Participants were sent monthly automated text messages to collect refill dates and pill counts that were taken and sent via mobile telephone photographs, and hair collection kits every 2 months by mail. At the study end, feasibility was calculated by specific metrics, such as the receipt of hair samples and responses to text messages. Participants completed a quantitative survey and qualitative exit interviews to examine the acceptability of these adherence evaluation methods. The relationship between the 3 novel metrics of adherence and self-reported adherence will be assessed. Investigators conducting adherence research are often limited to using either self-reported adherence, which is subjective, biased, and often overestimated, or other more complex methods. Here, we describe the protocol for evaluating the feasibility and acceptability of 3 novel and remote methods of estimating adherence, with the aim of evaluating the relationships between them. Additionally, we note the lessons learned from the protocol implementation to date. We expect that these novel measures will be feasible and acceptable. The implications of this research will be the identification and evaluation of innovative and accurate metrics of ARV adherence for future implementation.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials

PubMed Central

Martin, Staci; Merker, Vanessa L.; Gardner, Kathy L.; Hingtgen, Cynthia M.; Tonsgard, James H.; Schorry, Elizabeth K.; Baldwin, Andrea

2013-01-01

Objectives: Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. Methods: The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Results: Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥8 years. Conclusions: The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials. PMID:24249806

Feasibility of peer assessment and clinical audit to self-regulate the quality of physiotherapy services: a mixed methods study.

PubMed

Maas, Marjo J M; Nijhuis-van der Sanden, Maria W G; Driehuis, Femke; Heerkens, Yvonne F; van der Vleuten, Cees P M; van der Wees, Philip J

2017-02-10

To evaluate the feasibility of a quality improvement programme aimed to enhance the client-centeredness, effectiveness and transparency of physiotherapy services by addressing three feasibility domains: (1) acceptability of the programme design, (2) appropriateness of the implementation strategy and (3) impact on quality improvement. Mixed methods study. 64 physiotherapists working in primary care, organised in a network of communities of practice in the Netherlands. The programme contained: (1) two cycles of online self-assessment and peer assessment (PA) of clinical performance using client records and video-recordings of client communication followed by face-to-face group discussions, and (2) clinical audit assessing organisational performance. Assessment was based on predefined performance indicators which could be scored on a 5-point Likert scale. Discussions addressed performance standards and scoring differences. All feasibility domains were evaluated qualitatively with two focus groups and 10 in-depth interviews. In addition, we evaluated the impact on quality improvement quantitatively by comparing self-assessment and PA scores in cycles 1 and 2. We identified critical success features relevant to programme development and implementation, such as clarifying expectations at baseline, training in PA skills, prolonged engagement with video-assessment and competent group coaches. Self-reported impact on quality improvement included awareness of clinical and organisational performance, improved evidence-based practice and client-centeredness and increased motivation to self-direct quality improvement. Differences between self-scores and peer scores on performance indicators were not significant. Between cycles 1 and 2, scores for record keeping showed significant improvement, however not for client communication. This study demonstrated that bottom-up initiatives to improve healthcare quality can be effective. The results justify ongoing evaluation to inform nationwide implementation when the critical success features are addressed. Further research is necessary to explore the sustainability of the results and the impact on client outcomes in a full-scale study. 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/.

Feasibility, Acceptability and Findings from a Pilot Randomized Controlled Intervention Study on the Impact of a Book Designed to Inform Patients about Cancer Clinical Trials

PubMed Central

Carney, Patricia A.; Tucker, Erin K.; Newby, Timothy A.; Beer, Tomasz M.

2014-01-01

Objective To assess the feasibility, acceptability and changes in knowledge among cancer patients assigned to receive a 160 page book on experimental cancer therapies and clinical trials. Methods We enrolled 20 patients with cancer who had never participated in a clinical trial, and randomly assigned them to receive the book either during Week 1or Week 4 of the study. We collected baseline patient demographic and cancer related information as well as knowledge about cancer clinical trials at Week 0. Follow-up surveys were administered at Weeks 3 and 6 for both study groups. Comparisons were made within and between groups randomized to receive the book Early (at Week 1) to those who received it Later (at Week 4). Results One hundred percent of data were captured in both groups at baseline, which decreased to 77.8% by Week 6. The vast majority of participants found the book moderately or very useful (89% in the Early Group at Week 3 and 95.5% in the Late Group at Week 6). Within group pair-wise comparisons found significant difference between baseline and Week 6 in content-specific knowledge scores among participants in the Late Group (79% vs. 92.1%, p=0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. Conclusions Providing published reading material to patients with cancer is both feasible and acceptable. Offering information to patients about cancer clinical trials, using a book designed for patients with cancer may influence knowledge related to decision to participate in clinical trials. PMID:24127249

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

ERIC Educational Resources Information Center

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

2013-01-01

Family history of mental illness provides important information when evaluating pediatric bipolar disorder (PBD). However, such information is often challenging to gather within clinical settings. This study investigates the feasibility and utility of gathering family history information using an inexpensive method practical for outpatient…

Use of Outpatient Endometrial Biopsy in a Population with Intellectual Disability

ERIC Educational Resources Information Center

Jaffe, Joshua S.

2008-01-01

Background: To demonstrate the feasibility of outpatient endometrial sampling to evaluate abnormal uterine bleeding in a population of women with intellectual disability. Method: Retrospective chart review was completed of all endometrial biopsies performed on women attending a dedicated gynaecology clinic for women with intellectual disability…

Teledynamic Evaluation of Oropharyngeal Swallowing

ERIC Educational Resources Information Center

Malandraki, Georgia A.; McCullough, Gary; He, Xuming; McWeeny, Elizabeth; Perlman, Adrienne L.

2011-01-01

Purpose: The objective of the present investigation was to test the feasibility and clinical utility of a real-time Internet-based protocol for remote, telefluoroscopic evaluation of oropharyngeal swallowing. Method: In this prospective cohort study, the authors evaluated 32 patients with a primary diagnosis of stroke or head/neck cancer. All…

A mixed methods feasibility study to evaluate the use of a low-intensity, nurse-delivered cognitive behavioural therapy for the treatment of irritable bowel syndrome.

PubMed

Dainty, Andrew David; Fox, Mark; Lewis, Nina; Hunt, Melissa; Holtham, Elizabeth; Timmons, Stephen; Kinsella, Philip; Wragg, Andrew; Callaghan, Patrick

2014-06-17

Irritable bowel syndrome (IBS) is characterised by symptoms such as abdominal pain, constipation, diarrhoea and bloating. These symptoms impact on health-related quality of life, result in excess service utilisation and are a significant burden to healthcare systems. Certain mechanisms which underpin IBS can be explained by a biopsychosocial model which is amenable to psychological treatment using techniques such as cognitive behavioural therapy (CBT). While current evidence supports CBT interventions for this group of patients, access to these treatments within the UK healthcare system remains problematic. A mixed methods feasibility randomised controlled trial will be used to assess the feasibility of a low-intensity, nurse-delivered guided self-help intervention within secondary care gastrointestinal clinics. A total of 60 participants will be allocated across four treatment conditions consisting of: high-intensity CBT delivered by a fully qualified cognitive behavioural therapist, low-intensity guided self-help delivered by a registered nurse, self-help only without therapist support and a treatment as usual control condition. Participants from each of the intervention arms of the study will be interviewed in order to identify potential barriers and facilitators to the implementation of CBT interventions within clinical practice settings. Quantitative data will be analysed using descriptive statistics only. Qualitative data will be analysed using a group thematic analysis. This study will provide essential information regarding the feasibility of nurse-delivered CBT interventions within secondary care gastrointestinal clinics. The data gathered during this study would also provide useful information when planning a substantive trial and will assist funding bodies when considering investment in substantive trial funding. A favourable opinion for this research was granted by the Nottingham 2 Research Ethics Committee. 83683687 (http://www.controlled-trials.com/ISRCTN83683687). 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.

Assessing the feasibility of implementing low-cost virtual reality therapy during routine burn care.

PubMed

Ford, Cameron G; Manegold, Ellen M; Randall, Cameron L; Aballay, Ariel M; Duncan, Christina L

2018-06-01

Burn care often involves procedures that result in significant pain experiences for patients which, in turn, can lead to poorer physical and psychological health outcomes. Distraction and virtual reality (VR) are an effective adjunct to pharmacological interventions in reducing pain. Much of the research that has demonstrated efficacy for VR in burn care has involved expensive and extensive technology. Thus, identifying cost-effective, feasible, acceptable, and effective approaches to apply distraction within routine burn care is important. The objective of this mixed-methods study was to evaluate key stakeholder (i.e., patients, providers) perceptions of feasibility, acceptability, and effectiveness for the use of low-cost VR technology during routine burn care with adult patients. Ten adult patients used VR during burn care dressing changes in an outpatient clinic setting, after which they completed a satisfaction survey and individual qualitative interview. Providers also completed a satisfaction/perception survey after each participant's care. Quantitative and qualitative results from both patient and provider perspectives consistently supported the feasibility and utility of applying low-cost VR technology in this outpatient burn clinic setting. Special considerations (e.g., aspects to consider when choosing an apparatus or application) stemming from stakeholder feedback are discussed. Copyright © 2017 Elsevier Ltd and ISBI. All rights reserved.

Health coaching in primary care: a feasibility model for diabetes care.

PubMed

Liddy, Clare; Johnston, Sharon; Nash, Kate; Ward, Natalie; Irving, Hannah

2014-04-03

Health coaching is a new intervention offering a one-on-one focused self-management support program. This study implemented a health coaching pilot in primary care clinics in Eastern Ontario, Canada to evaluate the feasibility and acceptability of integrating health coaching into primary care for patients who were either at risk for or diagnosed with diabetes. We implemented health coaching in three primary care practices. Patients with diabetes were offered six months of support from their health coach, including an initial face-to-face meeting and follow-up by email, telephone, or face-to-face according to patient preference. Feasibility was assessed through provider focus groups and qualitative data analysis methods. All three sites were able to implement the program. A number of themes emerged from the focus groups, including the importance of physician buy-in, wide variation in understanding and implementing of the health coach role, the significant impact of different systems of team communication, and the significant effect of organizational structure and patient readiness on Health coaches' capacity to perform their role. It is feasible to implement health coaching as an integrated program within small primary care clinics in Canada without adding additional resources into the daily practice. Practices should review their organizational and communication processes to ensure optimal support for health coaches if considering implementing this intervention.

Evaluating the feasibility of using online software to collect patient information in a chiropractic practice-based research network

PubMed Central

Kania-Richmond, Ania; Weeks, Laura; Scholten, Jeffrey; Reney, Mikaël

2016-01-01

Background: Practice based research networks (PBRNs) are increasingly used as a tool for evidence based practice. We developed and tested the feasibility of using software to enable online collection of patient data within a chiropractic PBRN to support clinical decision making and research in participating clinics. Purpose: To assess the feasibility of using online software to collect quality patient information. Methods: The study consisted of two phases: 1) Assessment of the quality of information provided, using a standardized form; and 2) Exploration of patients’ perspectives and experiences regarding online information provision through semi-structured interviews. Data analysis was descriptive. Results: Forty-five new patients were recruited. Thirty-six completed online forms, which were submitted by an appropriate person 100% of the time, with an error rate of less than 1%, and submitted in a timely manner 83% of the time. Twenty-one participants were interviewed. Overall, online forms were preferred given perceived security, ease of use, and enabling provision of more accurate information. Conclusions: Use of online software is feasible, provides high quality information, and is preferred by most participants. A pen-and-paper format should be available for patients with this preference and in case of technical difficulties. PMID:27069272

Objective assessment in digital images of skin erythema caused by radiotherapy

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

Matsubara, H., E-mail: matubara@nirs.go.jp; Matsufuji, N.; Tsuji, H.

Purpose: Skin toxicity caused by radiotherapy has been visually classified into discrete grades. The present study proposes an objective and continuous assessment method of skin erythema in digital images taken under arbitrary lighting conditions, which is the case for most clinical environments. The purpose of this paper is to show the feasibility of the proposed method. Methods: Clinical data were gathered from six patients who received carbon beam therapy for lung cancer. Skin condition was recorded using an ordinary compact digital camera under unfixed lighting conditions; a laser Doppler flowmeter was used to measure blood flow in the skin. Themore » photos and measurements were taken at 3 h, 30, and 90 days after irradiation. Images were decomposed into hemoglobin and melanin colors using independent component analysis. Pixel values in hemoglobin color images were compared with skin dose and skin blood flow. The uncertainty of the practical photographic method was also studied in nonclinical experiments. Results: The clinical data showed good linearity between skin dose, skin blood flow, and pixel value in the hemoglobin color images; their correlation coefficients were larger than 0.7. It was deduced from the nonclinical that the uncertainty due to the proposed method with photography was 15%; such an uncertainty was not critical for assessment of skin erythema in practical use. Conclusions: Feasibility of the proposed method for assessment of skin erythema using digital images was demonstrated. The numerical relationship obtained helped to predict skin erythema by artificial processing of skin images. Although the proposed method using photographs taken under unfixed lighting conditions increased the uncertainty of skin information in the images, it was shown to be powerful for the assessment of skin conditions because of its flexibility and adaptability.« less

Recruiting Pregnant Patients for Survey Research: A Head to Head Comparison of Social Media-Based Versus Clinic-Based Approaches

PubMed Central

Haefner, Jessica K; Kolenic, Giselle E; Chang, Tammy; Davis, Matthew M; Moniz, Michelle H

2016-01-01

Background Recruiting a diverse sample of pregnant women for clinical research is a challenging but crucial task for improving obstetric services and maternal and child health outcomes. Objective To compare the feasibility and cost of recruiting pregnant women for survey research using social media-based and clinic-based approaches. Methods Advertisements were used to recruit pregnant women from the social media website Facebook. In-person methods were used to recruit pregnant women from the outpatient clinic of a large, tertiary care center. In both approaches, potential respondents were invited to participate in a 15-minute Web-based survey. Each recruitment method was monitored for 1 month. Using bivariate statistics, we compared the number, demographic characteristics, and health characteristics of women recruited and the cost per completed survey for each recruitment method. Results The social media-based approach recruited 1178 women and the clinic-based approach recruited 219 women. A higher proportion of subjects recruited through social media identified as African American (29.4%, 207/705 vs 11.2%, 20/179), reported household incomes

A pragmatic method for electronic medical record-based observational studies: developing an electronic medical records retrieval system for clinical research

PubMed Central

Yamamoto, Keiichi; Sumi, Eriko; Yamazaki, Toru; Asai, Keita; Yamori, Masashi; Teramukai, Satoshi; Bessho, Kazuhisa; Yokode, Masayuki; Fukushima, Masanori

2012-01-01

Objective The use of electronic medical record (EMR) data is necessary to improve clinical research efficiency. However, it is not easy to identify patients who meet research eligibility criteria and collect the necessary information from EMRs because the data collection process must integrate various techniques, including the development of a data warehouse and translation of eligibility criteria into computable criteria. This research aimed to demonstrate an electronic medical records retrieval system (ERS) and an example of a hospital-based cohort study that identified both patients and exposure with an ERS. We also evaluated the feasibility and usefulness of the method. Design The system was developed and evaluated. Participants In total, 800 000 cases of clinical information stored in EMRs at our hospital were used. Primary and secondary outcome measures The feasibility and usefulness of the ERS, the method to convert text from eligible criteria to computable criteria, and a confirmation method to increase research data accuracy. Results To comprehensively and efficiently collect information from patients participating in clinical research, we developed an ERS. To create the ERS database, we designed a multidimensional data model optimised for patient identification. We also devised practical methods to translate narrative eligibility criteria into computable parameters. We applied the system to an actual hospital-based cohort study performed at our hospital and converted the test results into computable criteria. Based on this information, we identified eligible patients and extracted data necessary for confirmation by our investigators and for statistical analyses with our ERS. Conclusions We propose a pragmatic methodology to identify patients from EMRs who meet clinical research eligibility criteria. Our ERS allowed for the efficient collection of information on the eligibility of a given patient, reduced the labour required from the investigators and improved the reliability of the results. PMID:23117567

Portable fluorescence lifetime spectroscopy system for in-situ interrogation of biological tissues.

PubMed

Saito Nogueira, Marcelo; Cosci, Alessandro; Teixeira Rosa, Ramon Gabriel; Salvio, Ana Gabriela; Pratavieira, Sebastião; Kurachi, Cristina

2017-10-01

Fluorescence spectroscopy and lifetime techniques are potential methods for optical diagnosis and characterization of biological tissues with an in-situ, fast, and noninvasive interrogation. Several diseases may be diagnosed due to differences in the fluorescence spectra of targeted fluorophores, when, these spectra are similar, considering steady-state fluorescence, others may be detected by monitoring their fluorescence lifetime. Despite this complementarity, most of the current fluorescence lifetime systems are not robust and portable, and not being feasible for clinical applications. We describe the assembly of a fluorescence lifetime spectroscopy system in a suitcase, its characterization, and validation with clinical measurements of skin lesions. The assembled system is all encased and robust, maintaining its mechanical, electrical, and optical stability during transportation, and is feasible for clinical measurements. The instrument response function measured was about 300 ps, and the system is properly calibrated. At the clinical study, the system showed to be reliable, and the achieved spectroscopy results support its potential use as an auxiliary tool for skin diagnostics. (2017) COPYRIGHT Society of Photo-Optical Instrumentation Engineers (SPIE).

A new method for real-time co-registration of 3D coronary angiography and intravascular ultrasound or optical coherence tomography.

PubMed

Carlier, Stéphane; Didday, Rich; Slots, Tristan; Kayaert, Peter; Sonck, Jeroen; El-Mourad, Mike; Preumont, Nicolas; Schoors, Dany; Van Camp, Guy

2014-06-01

We present a new clinically practical method for online co-registration of 3D quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) or optical coherence tomography (OCT). The workflow is based on two modified commercially available software packages. Reconstruction steps are explained and compared to previously available methods. The feasibility for different clinical scenarios is illustrated. The co-registration appears accurate, robust and induced a minimal delay on the normal cath lab activities. This new method is based on the 3D angiographic reconstruction of the catheter path and does not require operator's identification of landmarks to establish the image synchronization. Copyright © 2014 Elsevier Inc. All rights reserved.

The combination design for open and endoscopic surgery using fluorescence molecular imaging technology

NASA Astrophysics Data System (ADS)

Mao, Yamin; Jiang, Shixin; Ye, Jinzuo; An, Yu; Yang, Xin; Chi, Chongwei; Tian, Jie

2015-03-01

For clinical surgery, it is still a challenge to objectively determine tumor margins during surgery. With the development of medical imaging technology, fluorescence molecular imaging (FMI) method can provide real-time intraoperative tumor margin information. Furthermore, surgical navigation system based on FMI technology plays an important role for the aid of surgeons' precise tumor margin decision. However, detection depth is the most limitation exists in the FMI technique and the method convenient for either macro superficial detection or micro deep tissue detection is needed. In this study, we combined advantages of both open surgery and endoscopic imaging systems with FMI technology. Indocyanine green (ICG) experiments were performed to confirm the feasibility of fluorescence detection in our system. Then, the ICG signal was photographed in the detection area with our system. When the system connected with endoscope lens, the minimum quantity of ICG detected by our system was 0.195 ug. For aspect of C mount lens, the sensitivity of ICG detection with our system was 0.195ug. Our experiments results proved that it was feasible to detect fluorescence images with this combination method. Our system shows great potential in the clinical applications of precise dissection of various tumors

Detecting breast microcalcifications using super-resolution ultrasound imaging: a clinical study

NASA Astrophysics Data System (ADS)

Huang, Lianjie; Labyed, Yassin; Hanson, Kenneth; Sandoval, Daniel; Pohl, Jennifer; Williamson, Michael

2013-03-01

Imaging breast microcalcifications is crucial for early detection and diagnosis of breast cancer. It is challenging for current clinical ultrasound to image breast microcalcifications. However, new imaging techniques using data acquired with a synthetic-aperture ultrasound system have the potential to significantly improve ultrasound imaging. We recently developed a super-resolution ultrasound imaging method termed the phase-coherent multiple-signal classification (PC-MUSIC). This signal subspace method accounts for the phase response of transducer elements to improve image resolution. In this paper, we investigate the clinical feasibility of our super-resolution ultrasound imaging method for detecting breast microcalcifications. We use our custom-built, real-time synthetic-aperture ultrasound system to acquire breast ultrasound data for 40 patients whose mammograms show the presence of breast microcalcifications. We apply our super-resolution ultrasound imaging method to the patient data, and produce clear images of breast calcifications. Our super-resolution ultrasound PC-MUSIC imaging with synthetic-aperture ultrasound data can provide a new imaging modality for detecting breast microcalcifications in clinic without using ionizing radiation.

Evaluation of a novel vital sign device to reduce maternal mortality and morbidity in low-resource settings: a mixed method feasibility study for the CRADLE-3 trial.

PubMed

Vousden, Nicola; Lawley, Elodie; Nathan, Hannah L; Seed, Paul T; Brown, Adrian; Muchengwa, Tafadzwa; Charantimath, Umesh; Bellad, Mrutyunjaya; Gidiri, Muchabayiwa Francis; Goudar, Shivaprasad; Chappell, Lucy C; Sandall, Jane; Shennan, Andrew H

2018-04-27

The CRADLE-3 trial is a stepped-wedge randomised controlled trial aiming to reduce maternal mortality and morbidity by implementing a novel vital sign device (CRADLE Vital Sign Alert) and training package into routine maternity care in 10 low-income sites. The MRC Guidance on complex interventions proposes that interventions and implementation strategies be shaped by early phase piloting and development work. We present the findings of a three-month mixed-methodology feasibility study for this trial, describe how this was informed by the MRC guidance and the study design was refined. The fidelity, dose, feasibility and acceptability of implementation and training materials were assessed in three representative non-trial sites (Zimbabwe, Ethiopia, India) using multiple-choice questionnaires, evaluation of clinical management (action log), healthcare provider (HCP) semi-structured interviews and focus groups 4-10 weeks after implementation. Simultaneously, the 10 sites included in the main trial (eight countries) collected primary outcome data to inform the power calculation and randomisation allocation and assess the feasibility of data collection. The package was implemented with high fidelity (85% of HCP trained, n = 204). The questionnaires indicated a good understanding of device use with 75% of participants scoring > 75% (n = 97; 90% of those distributed). Action logs were inconsistently completed but indicated that the majority of HCP responded appropriately to abnormal results. From 18 HCP interviews and two focus groups it was widely reported that the intervention improved capacity to make clinical decisions, escalate care and make appropriate referrals. Nine of the ten main trial sites achieved ethical approval for pilot data collection. Intensive care was an inconsistent marker of morbidity and stroke an infrequent outcome and therefore they were removed from the main trial composite outcome. Tools and methods of data collection were optimized and event rates used to inform randomisation. This feasibility study demonstrates that the components of the intervention were acceptable, methods of implementing were successful and the main trial design would be feasible. Qualitative work identified key moderators that informed the main trial process evaluation. Changes to the training package, implementation strategy, study design and processes were identified to refine the implementation in the main trial. ISRCTN41244132 ; Registered 24/11/2015.

Robotic and endoscopic transoral thyroidectomy: feasibility and description of the technique in the cadaveric model

PubMed Central

Kahramangil, Bora; Mohsin, Khuzema; Alzahrani, Hassan; Bu Ali, Daniah; Tausif, Syed; Kang, Sang-Wook; Kandil, Emad

2017-01-01

Background Numerous new approaches have been described over the years to improve the cosmetic outcomes of thyroid surgery. Transoral approach is a new technique that aims to achieve superior cosmetic outcomes by concealing the incision in the oral cavity. Methods Transoral thyroidectomy through vestibular approach was performed in two institutions on cadaveric models. Procedure was performed endoscopically in one institution, while the robotic technique was utilized at the other. Results Transoral thyroidectomy was successfully performed at both institutions with robotic and endoscopic techniques. All vital structures were identified and preserved. Conclusions Transoral thyroidectomy has been performed in animal and cadaveric models, as well as in some clinical studies. Our initial experience indicates the feasibility of this approach. More clinical studies are required to elucidate its full utility. PMID:29302476

Isothermal multiple displacement amplification: a methodical approach enhancing molecular routine diagnostics of microcarcinomas and small biopsies.

PubMed

Mairinger, Fabian D; Walter, Robert Fh; Vollbrecht, Claudia; Hager, Thomas; Worm, Karl; Ting, Saskia; Wohlschläger, Jeremias; Zarogoulidis, Paul; Zarogoulidis, Konstantinos; Schmid, Kurt W

2014-01-01

Isothermal multiple displacement amplification (IMDA) can be a powerful tool in molecular routine diagnostics for homogeneous and sequence-independent whole-genome amplification of notably small tumor samples, eg, microcarcinomas and biopsies containing a small amount of tumor. Currently, this method is not well established in pathology laboratories. We designed a study to confirm the feasibility and convenience of this method for routine diagnostics with formalin-fixed, paraffin-embedded samples prepared by laser-capture microdissection. A total of 250 μg DNA (concentration 5 μg/μL) was generated by amplification over a period of 8 hours with a material input of approximately 25 cells, approximately equivalent to 175 pg of genomic DNA. In the generated DNA, a representation of all chromosomes could be shown and the presence of elected genes relevant for diagnosis in clinical samples could be proven. Mutational analysis of clinical samples could be performed without any difficulty and showed concordance with earlier diagnostic findings. We established the feasibility and convenience of IMDA for routine diagnostics. We also showed that small amounts of DNA, which were not analyzable with current molecular methods, could be sufficient for a wide field of applications in molecular routine diagnostics when they are preamplified with IMDA.

Whole kidney engineering for clinical translation.

PubMed

Kim, Ick-Hee; Ko, In Kap; Atala, Anthony; Yoo, James J

2015-04-01

Renal transplantation is currently the only definitive treatment for end-stage renal disease; however, this treatment is severely limited by the shortage of implantable kidneys. To address this shortcoming, development of an engineered, transplantable kidney has been proposed. Although current advances in engineering kidneys based on decellularization and recellularization techniques have offered great promises for the generation of functional kidney constructs, most studies have been conducted using rodent kidney constructs and short-term in-vivo evaluation. Toward clinical translations of this technique, several limitations need to be addressed. Human-sized renal scaffolds are desirable for clinical application, and the fabrication is currently feasible using native porcine and discarded human kidneys. Current progress in stem cell biology and cell culture methods have demonstrated feasibility of the use of embryonic stem cells, induced pluripotent stem cells, and primary renal cells as clinically relevant cell sources for the recellularization of renal scaffolds. Finally, approaches to long-term implantation of engineered kidneys are under investigation using antithrombogenic strategies such as functional reendothelialization of acellular kidney matrices. In the field of bioengineering, whole kidneys have taken a number of important initial steps toward clinical translations, but many challenges must be addressed to achieve a successful treatment for the patient with end-stage renal disease.

Assessing Binocular Interaction in Amblyopia and Its Clinical Feasibility

PubMed Central

Kwon, MiYoung; Lu, Zhong-Lin; Miller, Alexandra; Kazlas, Melanie; Hunter, David G.; Bex, Peter J.

2014-01-01

Purpose To measure binocular interaction in amblyopes using a rapid and patient-friendly computer-based method, and to test the feasibility of the assessment in the clinic. Methods Binocular interaction was assessed in subjects with strabismic amblyopia (n = 7), anisometropic amblyopia (n = 6), strabismus without amblyopia (n = 15) and normal vision (n = 40). Binocular interaction was measured with a dichoptic phase matching task in which subjects matched the position of a binocular probe to the cyclopean perceived phase of a dichoptic pair of gratings whose contrast ratios were systematically varied. The resulting effective contrast ratio of the weak eye was taken as an indicator of interocular imbalance. Testing was performed in an ophthalmology clinic under 8 mins. We examined the relationships between our binocular interaction measure and standard clinical measures indicating abnormal binocularity such as interocular acuity difference and stereoacuity. The test-retest reliability of the testing method was also evaluated. Results Compared to normally-sighted controls, amblyopes exhibited significantly reduced effective contrast (∼20%) of the weak eye, suggesting a higher contrast requirement for the amblyopic eye compared to the fellow eye. We found that the effective contrast ratio of the weak eye covaried with standard clincal measures of binocular vision. Our results showed that there was a high correlation between the 1st and 2nd measurements (r = 0.94, p<0.001) but without any significant bias between the two. Conclusions Our findings demonstrate that abnormal binocular interaction can be reliably captured by measuring the effective contrast ratio of the weak eye and quantitative assessment of binocular interaction is a quick and simple test that can be performed in the clinic. We believe that reliable and timely assessment of deficits in a binocular interaction may improve detection and treatment of amblyopia. PMID:24959842

The Men's Safer Sex project: intervention development and feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men.

PubMed

Bailey, Julia V; Webster, Rosie; Hunter, Rachael; Griffin, Mark; Freemantle, Nicholas; Rait, Greta; Estcourt, Claudia; Michie, Susan; Anderson, Jane; Stephenson, Judith; Gerressu, Makeda; Ang, Chee Siang; Murray, Elizabeth

2016-12-01

This report details the development of the Men's Safer Sex website and the results of a feasibility randomised controlled trial (RCT), health economic assessment and qualitative evaluation. (1) Develop the Men's Safer Sex website to address barriers to condom use; (2) determine the best design for an online RCT; (3) inform the methods for collecting and analysing health economic data; (4) assess the Sexual Quality of Life (SQoL) questionnaire and European Quality of Life-5 Dimensions, three-level version (EQ-5D-3L) to calculate quality-adjusted life-years (QALYs); and (5) explore clinic staff and men's views of online research methodology. (1) Website development: we combined evidence from research literature and the views of experts ( n  = 18) and male clinic users ( n  = 43); (2) feasibility RCT: 159 heterosexually active men were recruited from three sexual health clinics and were randomised by computer to the Men's Safer Sex website plus usual care ( n  = 84) or usual clinic care only ( n  = 75). Men were invited to complete online questionnaires at 3, 6, 9 and 12 months, and sexually transmitted infection (STI) diagnoses were recorded from clinic notes at 12 months; (3) health economic evaluation: we investigated the impact of using different questionnaires to calculate utilities and QALYs (the EQ-5D-3L and SQoL questionnaire), and compared different methods to collect resource use; and (4) qualitative evaluation: thematic analysis of interviews with 11 male trial participants and nine clinic staff, as well as free-text comments from online outcome questionnaires. (1) Software errors and clinic Wi-Fi access presented significant challenges. Response rates for online questionnaires were poor but improved with larger vouchers (from 36% with £10 to 50% with £30). Clinical records were located for 94% of participants for STI diagnoses. There were no group differences in condomless sex with female partners [incidence rate ratio (IRR) 1.01, 95% confidence interval (CI) 0.52 to 1.96]. New STI diagnoses were recorded for 8.8% (7/80) of the intervention group and 13.0% (9/69) of the control group (IRR 0.75, 95% CI 0.29 to 1.89). (2) Health-care resource data were more complete using patient files than questionnaires. The probability that the intervention is cost-effective is sensitive to the source of data used and whether or not data on intended pregnancies are included. (3) The pilot RCT fitted well around clinical activities but 37% of the intervention group did not see the Men's Safer Sex website and technical problems were frustrating. Men's views of the Men's Safer Sex website and research procedures were largely positive. It would be feasible to conduct a large-scale RCT using clinic STI diagnoses as a primary outcome; however, technical errors and a poor response rate limited the collection of online self-reported outcomes. The next steps are (1) to optimise software for online trials, (2) to find the best ways to integrate digital health promotion with clinical services, (3) to develop more precise methods for collecting resource use data and (4) to work out how to overcome barriers to digital intervention testing and implementation in the NHS. Current Controlled Trials ISRCTN18649610. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 20, No. 91. See the NIHR Journals Library website for further project information.

Application of Bayesian Approach in Cancer Clinical Trial

PubMed Central

Bhattacharjee, Atanu

2014-01-01

The application of Bayesian approach in clinical trials becomes more useful over classical method. It is beneficial from design to analysis phase. The straight forward statement is possible to obtain through Bayesian about the drug treatment effect. Complex computational problems are simple to handle with Bayesian techniques. The technique is only feasible to performing presence of prior information of the data. The inference is possible to establish through posterior estimates. However, some limitations are present in this method. The objective of this work was to explore the several merits and demerits of Bayesian approach in cancer research. The review of the technique will be helpful for the clinical researcher involved in the oncology to explore the limitation and power of Bayesian techniques. PMID:29147387

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic

PubMed Central

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B.

2016-01-01

Background: The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. Objectives: A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. Study Design/Methods: This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. Results: The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. Conclusions: This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies. PMID:29444602

Accrual and recruitment practices at Clinical and Translational Science Award (CTSA) institutions: a call for expectations, expertise, and evaluation.

PubMed

Kost, Rhonda G; Mervin-Blake, Sabrena; Hallarn, Rose; Rathmann, Charles; Kolb, H Robert; Himmelfarb, Cheryl Dennison; D'Agostino, Toni; Rubinstein, Eric P; Dozier, Ann M; Schuff, Kathryn G

2014-08-01

To respond to increased public and programmatic demand to address underenrollment of clinical translational research studies, the authors examined participant recruitment practices at Clinical and Translational Science Award (CTSA) sites and make recommendations for performance metrics and accountability. The CTSA Recruitment and Retention taskforce in 2010 invited representatives at 46 CTSAs to complete an online 48-question survey querying accrual and recruitment outcomes, practices, evaluation methods, policies, and perceived gaps in related knowledge/practice. Descriptive statistical and thematic analyses were conducted. Forty-six respondents representing 44 CTSAs completed the survey. Recruitment conducted by study teams was the most common practice reported (78%-91%, by study type); 39% reported their institution offered recruitment services to investigators. Respondents valued study feasibility assessment as a successful practice (39%); desired additional resources included feasibility assessments (49%) and participant registries (44%). None reported their institution systematically required justification of feasibility; some indicated relevant information was considered prior to institutional review board (IRB) review (30%) or contract approval (22%). All respondents' IRBs tracked study progress, but only 10% of respondents could report outcome data for timely accrual. Few reported written policies addressing poor accrual or provided data to support recruitment practice effectiveness. Many CTSAs lack the necessary frame work to support study accrual. Recom men dations to enhance accrual include articulating institutional expectations and policy for routine recruitment plan ning; providing recruitment expertise to inform feasibility assessment and recruit ment planning; and developing interdepartmental coordination and integrated informatics infrastructure to drive the conduct, evaluation, and improvement of recruitment practices.

Where have all the pilot studies gone? A follow-up on 30 years of pilot studies in Clinical Rehabilitation

PubMed Central

Kaur, Navaldeep; Figueiredo, Sabrina; Bouchard, Vanessa; Moriello, Carolina; Mayo, Nancy

2017-01-01

Introduction: Pilot studies are meritorious for determining the feasibility of a definitive clinical trial in terms of conduct and potential for efficacy, but their possible applications for planning a future trial are not always fully realized. The purpose of this review was to estimate the extent to which pilot/feasibility studies: (i) addressed needed objectives; (ii) led to definitive trials; and (iii) whether the subsequent undertaking of a definitive trial was influenced by the strength of the evidence of outcome improvement. Methods: Trials published in the journal Clinical Rehabilitation, since its inception, were eligible if the word ‘pilot’ or ‘feasibility’ was specified somewhere in the article. A total of 191 studies were reviewed, results were summarized descriptively, and between-group effect sizes were computed. Results: The specific purposes of piloting were stated in only 58% (n = 110) of the studies. The most frequent purpose was to estimate the potential for efficacy (85%), followed by testing the feasibility of the intervention (60%). Only 12% of the studies were followed by a definitive trial; <4% of studies had a main study underway or a published study protocol. There was no relationship between observed effect size and follow-up of pilot studies, although the confidence intervals were very wide owing to small number of trials that followed on. Discussion: Labelling and reporting of pilot studies needs to be improved to be concordant with the recently issued CONSORT guidelines. Feasibility needs to be fully tested and demonstrated prior to committing considerable human and monetary resources. PMID:28786333

Teaching "Global Mental Health:" Psychiatry Residency Directors' Attitudes and Practices regarding International Opportunities for Psychiatry Residents

ERIC Educational Resources Information Center

Belkin, Gary S.; Yusim, Anna; Anbarasan, Deepti; Bernstein, Carol Ann

2011-01-01

Objective: The authors surveyed Psychiatry Residency Training Directors' (RTDs') attitudes about the role and feasibility of international rotations during residency training. Method: A 21-question survey was electronically distributed that explored RTDs' beliefs about the value, use, and availability of international clinical and research…

An open clinical trial assessing a novel training program for social cognitive impairment in schizophrenia.

PubMed

Marsh, Pamela; Langdon, Robyn; McGuire, Jonathan; Harris, Anthony; Polito, Vince; Coltheart, Max

2013-04-01

Social cognition is profoundly impaired in patients with schizophrenia. This study describes 'Mental-State Reasoning Training for Social Cognitive Impairment' (SoCog-MSRT), a 5-week program developed to improve social cognition in patients with schizophrenia. We aimed to investigate the feasibility of implementing SoCog-MSRT in a rehabilitation setting and to evaluate whether our training methods produced improvements. METHOD The feasibility and benefits of SoCog-MSRT were evaluated in an open clinical trial with 14 participants with schizophrenia or schizoaffective disorder. Training comprised 10 twice-weekly sessions, for 5 weeks, with a pre- and post-training assessment. There were significant improvements on: (a) a classic false-belief test of Theory of Mind (ToM); (b) inferring complex mental states from the eyes; and (c) a self-reported measure of social understanding. Some of these improvements were associated with baseline levels of working memory and premorbid Intelligence Quotient (IQ). CONCLUSIONS SoCog-MSRT can improve ToM abilities and social understanding, but individuals with poorer working memory and lower premorbid IQ may be less able to benefit from this type of training.

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs†

PubMed Central

Clarke, Diana E.; Wilcox, Holly C.; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H.; Newcomer, Alison; Mckitty, Mellisha V.; Regier, Darrel A.; Narrow, William E.

2014-01-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients’ experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. PMID:24615761

Bioelectrical impedance methods in clinical research: a follow-up to the NIH Technology Assessment Conference.

PubMed

Ellis, K J; Bell, S J; Chertow, G M; Chumlea, W C; Knox, T A; Kotler, D P; Lukaski, H C; Schoeller, D A

1999-01-01

In 1994, the National Institutes of Health (NIH) convened a Technology Assessment Conference "to provide physicians with a responsible assessment of bioelectrical impedance analysis (BIA) technology for body composition measurement." In 1997, Serono Symposia USA, Inc., organized an invited panel of scientists and clinicians, with extensive research and clinical experience with BIA, to provide an update. Panel members presented reviews based on their own work and published studies for the intervening years. Updates were provided on the single and multifrequency BIA methods and models; continued clinical research experiences; efforts toward establishing population reference norms; and the feasibility of establishing guidelines for potential diagnostic use of BIA in a clinical setting. This report provides a summary of the panel's findings including a consensus on several technical and clinical issues related to the research use of BIA, and those areas that are still in need of additional study.

Selecting relevant and feasible measurement instruments for the revised Dutch clinical practice guideline for physical therapy in patients after stroke.

PubMed

Otterman, Nicoline; Veerbeek, Janne; Schiemanck, Sven; van der Wees, Philip; Nollet, Frans; Kwakkel, Gert

2017-07-01

To select relevant and feasible instruments for the revision of the Dutch clinical practice guideline for physical therapy in patients with stroke. In this implementation study a comprehensive proposal for ICF categories and matching instruments was developed, based on reliability and validity. Relevant instruments were then selected in a consensus round by 11 knowledge brokers who were responsible for the implementation of the selected instruments. The feasibility of the selected instruments was tested by 36 physical therapists at different work settings within stroke services. Finally, instruments that were deemed relevant and feasible were included in the revised guideline. A total of 28 instruments were recommended for inclusion in the revised guideline. Nineteen instruments were retained from the previous guideline. Ten new instruments were tested in clinical practice, seven of which were found feasible. Two more instruments were added after critical appraisal of the set of the measurement instruments. The revised guideline contains 28 relevant and feasible instrument selected and tested in clinical practice by physical therapists. Further education and implementation is needed to integrate instruments in clinical practice. Further research is proposed for developing and implementing a core set of measurement instruments to be used at fixed time points to establish data registries that allow for continuous improvement of rehabilitation for stroke patients. Implications for Rehabilitation The revised Dutch Stroke Physical Therapy Guideline recommends a total of 28 instruments, that are relevant and feasible for clinical practice of physical therapist in the different settings of stroke rehabilitation. The selection of instrument in daily practice should be part of the clinical reasoning process of PTs and be tailored to individual patients' needs and the degree of priority of the affected ICF category. Suggested education strategies for further integration of instruments in of the daily practice of PTs in Stroke Rehabilitation are: 'Training on the job' and 'peer assessment in clinical situations'.

The feasibility of a randomized controlled trial of esophagectomy for esophageal cancer - the ROMIO (Randomized Oesophagectomy: Minimally Invasive or Open) study: protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background There is a need for evidence of the clinical effectiveness of minimally invasive surgery for the treatment of esophageal cancer, but randomized controlled trials in surgery are often difficult to conduct. The ROMIO (Randomized Open or Minimally Invasive Oesophagectomy) study will establish the feasibility of a main trial which will examine the clinical and cost-effectiveness of minimally invasive and open surgical procedures for the treatment of esophageal cancer. Methods/Design A pilot randomized controlled trial (RCT), in two centers (University Hospitals Bristol NHS Foundation Trust and Plymouth Hospitals NHS Trust) will examine numbers of incident and eligible patients who consent to participate in the ROMIO study. Interventions will include esophagectomy by: (1) open gastric mobilization and right thoracotomy, (2) laparoscopic gastric mobilization and right thoracotomy, and (3) totally minimally invasive surgery (in the Bristol center only). The primary outcomes of the feasibility study will be measures of recruitment, successful development of methods to monitor quality of surgery and fidelity to a surgical protocol, and development of a core outcome set to evaluate esophageal cancer surgery. The study will test patient-reported outcomes measures to assess recovery, methods to blind participants, assessments of surgical morbidity, and methods to capture cost and resource use. ROMIO will integrate methods to monitor and improve recruitment using audio recordings of consultations between recruiting surgeons, nurses, and patients to provide feedback for recruiting staff. Discussion The ROMIO study aims to establish efficient methods to undertake a main trial of minimally invasive surgery versus open surgery for esophageal cancer. Trial registration The pilot trial has Current Controlled Trials registration number ISRCTN59036820(25/02/2013) at http://www.controlled-trials.com; the ROMIO trial record at that site gives a link to the original version of the study protocol. PMID:24888266

A novel pretreatment method combining sealing technique with direct injection technique applied for improving biosafety.

PubMed

Wang, Xinyu; Gao, Jing-Lin; Du, Chaohui; An, Jing; Li, MengJiao; Ma, Haiyan; Zhang, Lina; Jiang, Ye

2017-01-01

People today have a stronger interest in the risk of biosafety in clinical bioanalysis. A safe, simple, effective method of preparation is needed urgently. To improve biosafety of clinical analysis, we used antiviral drugs of adefovir and tenofovir as model drugs and developed a safe pretreatment method combining sealing technique with direct injection technique. The inter- and intraday precision (RSD %) of the method were <4%, and the extraction recoveries ranged from 99.4 to 100.7%. Meanwhile, the results showed that standard solution could be used to prepare calibration curve instead of spiking plasma, acquiring more accuracy result. Compared with traditional methods, the novel method not only improved biosecurity of the pretreatment method significantly, but also achieved several advantages including higher precision, favorable sensitivity and satisfactory recovery. With these highly practical and desirable characteristics, the novel method may become a feasible platform in bioanalysis.

A feasibility study examining the effect on lung cancer diagnosis of offering a chest X-ray to higher-risk patients with chest symptoms: protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background In order to improve lung cancer survival in the UK, a greater proportion of resectable cancers must be diagnosed. It is likely that resectability rates would be increased by more timely diagnosis. Aside from screening, the only way of achieving this is to reduce the time to diagnosis in symptomatic cancers. Currently, lung cancers are mainly diagnosed by general practitioners (GPs) using the National Institute for Health and Clinical Excellence (NICE) guidelines for urgent referral for chest X-ray, which recommend urgent imaging or referral for patients who have one of a number of chest symptoms for more than 3 weeks. We are proposing to expand this recommendation to include one of a number of chest symptoms of any duration in higher-risk patients. Methods/Design We intend to conduct a trial of imaging in these higher-risk patients and compare it with NICE guidelines to see if imaging improves stage at diagnosis and resection rates. This trial would have to be large (and consequently resource-intensive) because most of these patients will not have lung cancer, making optimal design crucial. We are therefore conducting a pilot trial that will ascertain the feasibility of running a full trial and provide key information that will be required in order to design the full trial. Discussion This trial will assess the feasibility and inform the design of a large, UK-wide, clinical trial of a change to the NICE guidelines for urgent referral for chest X-ray for suspected lung cancer. It utilizes a combination of workshop, health economic, quality of life, qualitative, and quantitative methods in order to fully assess feasibility. Trial registration Clinicaltrials.gov NCT01344005 PMID:24279296

Is early integration of palliative care feasible and acceptable for advanced respiratory and gastrointestinal cancer patients? A phase 2 mixed-methods study.

PubMed

Costantini, Massimo; Apolone, Giovanni; Tanzi, Silvia; Falco, Francesco; Rondini, Ermanno; Guberti, Monica; Fanello, Silvia; Cavuto, Silvio; Savoldi, Luisa; Piro, Roberto; Mecugni, Daniela; Di Leo, Silvia

2018-01-01

There is evidence that early integration of palliative care improves quality of life, lowers spending and helps clarify preferences and goals for advanced cancer patients. Little is known about the feasibility and acceptability of early integration. Assessing feasibility of early integration of palliative care, and exploring concerns perceived and problems encountered by patients, relatives and oncologists. A phase 2 mixed-methods study ( ClinicalTrials.Gov :NCT02078700). Oncologists of two outpatient clinics offered a specialised palliative care intervention integrated with standard oncological care to all consecutive newly diagnosed metastatic respiratory/gastrointestinal cancer patients. We interviewed samples of patients, relatives and oncologists to explore strengths and weaknesses of the intervention. The intervention was proposed to 44/54 eligible patients (81.5%), 40 (90.1%) accepted, 38 (95.0%) attended the first palliative care visit. The intervention was completed for 32 patients (80.0%). It did not start for three (7.5%) and was interrupted for three patients who refused (7.5%). The Palliative Care Unit performed 274 visits in 38 patients (median per patient 4.5), and 24 family meetings with relatives of 16 patients. All patients and most relatives referred to the usefulness of the intervention, specifically for symptoms management, information and support to strategies for coping. Oncologists highlighted their difficulties in informing patients on palliative intervention, sharing information and coordinating patient's care with the palliative care team. Early integration of palliative care in oncological setting seems feasible and well accepted by patients, relatives and, to a lesser extent, oncologists. Some difficulties emerged concerning patient information and inter-professional communication.

Integration of Evidence into a Detailed Clinical Model-based Electronic Nursing Record System

PubMed Central

Park, Hyeoun-Ae; Jeon, Eunjoo; Chung, Eunja

2012-01-01

Objectives The purpose of this study was to test the feasibility of an electronic nursing record system for perinatal care that is based on detailed clinical models and clinical practice guidelines in perinatal care. Methods This study was carried out in five phases: 1) generating nursing statements using detailed clinical models; 2) identifying the relevant evidence; 3) linking nursing statements with the evidence; 4) developing a prototype electronic nursing record system based on detailed clinical models and clinical practice guidelines; and 5) evaluating the prototype system. Results We first generated 799 nursing statements describing nursing assessments, diagnoses, interventions, and outcomes using entities, attributes, and value sets of detailed clinical models for perinatal care which we developed in a previous study. We then extracted 506 recommendations from nine clinical practice guidelines and created sets of nursing statements to be used for nursing documentation by grouping nursing statements according to these recommendations. Finally, we developed and evaluated a prototype electronic nursing record system that can provide nurses with recommendations for nursing practice and sets of nursing statements based on the recommendations for guiding nursing documentation. Conclusions The prototype system was found to be sufficiently complete, relevant, useful, and applicable in terms of content, and easy to use and useful in terms of system user interface. This study has revealed the feasibility of developing such an ENR system. PMID:22844649

Exploring the Feasibility of Service Integration in a Low-Income Setting: A Mixed Methods Investigation into Different Models of Reproductive Health and HIV Care in Swaziland

PubMed Central

Church, Kathryn; Wringe, Alison; Lewin, Simon; Ploubidis, George B.; Fakudze, Phelele; Mayhew, Susannah H.

2015-01-01

Integrating reproductive health (RH) with HIV care is a policy priority in high HIV prevalence settings, despite doubts surrounding its feasibility and varying evidence of effects on health outcomes. The process and outcomes of integrated RH-HIV care were investigated in Swaziland, through a comparative case study of four service models, ranging from fully integrated to fully stand-alone HIV services, selected purposively within one town. A client exit survey (n=602) measured integrated care received and unmet family planning (FP) needs. Descriptive statistics were used to assess the degree of integration per clinic and client demand for services. Logistic regression modelling was used to test the hypothesis that clients at more integrated sites had lower unmet FP needs than clients in a stand-alone site. Qualitative methods included in-depth interviews with clients and providers to explore contextual factors influencing the feasibility of integrated RH-HIV care delivery; data were analysed thematically, combining deductive and inductive approaches. Results demonstrated that clinic models were not as integrated in practice as had been claimed. Fragmentation of HIV care was common. Services accessed per provider were no higher at the more integrated clinics compared to stand-alone models (p>0.05), despite reported demand. While women at more integrated sites received more FP and pregnancy counselling than stand-alone models, they received condoms (a method of choice) less often, and there was no statistical evidence of difference in unmet FP needs by model of care. Multiple contextual factors influenced integration practices, including provider de-skilling within sub-specialist roles; norms of task-oriented routinised HIV care; perceptions of heavy client loads; imbalanced client-provider interactions hindering articulation of RH needs; and provider motivation challenges. Thus, despite institutional support, factors related to the social context of care inhibited provision of fully integrated RH-HIV services in these clinics. Programmes should move beyond simplistic training and equipment provision if integrated care interventions are to be sustained. PMID:25978632

Implementing resilience engineering for healthcare quality improvement using the CARE model: a feasibility study protocol.

PubMed

Anderson, J E; Ross, A J; Back, J; Duncan, M; Snell, P; Walsh, K; Jaye, P

2016-01-01

Resilience engineering (RE) is an emerging perspective on safety in complex adaptive systems that emphasises how outcomes emerge from the complexity of the clinical environment. Complexity creates the need for flexible adaptation to achieve outcomes. RE focuses on understanding the nature of adaptations, learning from success and increasing adaptive capacity. Although the philosophy is clear, progress in applying the ideas to quality improvement has been slow. The aim of this study is to test the feasibility of translating RE concepts into practical methods to improve quality by designing, implementing and evaluating interventions based on RE theory. The CARE model operationalises the key concepts and their relationships to guide the empirical investigation. The settings are the Emergency Department and the Older Person's Unit in a large London teaching hospital. Phases 1 and 2 of our work, leading to the development of interventions to improve the quality of care, are described in this paper. Ethical approval has been granted for these phases. Phase 1 will use ethnographic methods, including observation of work practices and interviews with staff, to understand adaptations and outcomes. The findings will be used to collaboratively design, with clinical staff in interactive design workshops, interventions to improve the quality of care. The evaluation phase will be designed and submitted for ethical approval when the outcomes of phases 1 and 2 are known. Study outcomes will be knowledge about the feasibility of applying RE to improve quality, the development of RE theory and a validated model of resilience in clinical work which can be used to guide other applications. Tools, methods and practical guidance for practitioners will also be produced, as well as specific knowledge of the potential effectiveness of the implemented interventions in emergency and older people's care. Further studies to test the application of RE at a larger scale will be required, including studies of other healthcare settings, organisational contexts and different interventions.

Feasibility of a Respiratory Movement Evaluation Tool to Quantify Thoracoabdominal Movement for Neuromuscular Diseases.

PubMed

Liu, Fumio; Kawakami, Michiyuki; Tamura, Kimimasa; Taki, Yoshihito; Shimizu, Katsumi; Otsuka, Tomoyoshi; Tsuji, Tetsuya; Miyata, Chieko; Tashiro, Syoichi; Wada, Ayako; Mizuno, Katsuhiro; Aoki, Yoshimitsu; Liu, Meigen

2017-04-01

An objective method to evaluate thoracoabdominal movement is needed in daily clinical practice to detect patients at risk of hypoventilation and to allow for timely interventions in neuromuscular diseases. The clinical feasibility, reliability, and validity of a newly developed method for quantifying respiratory movement using fiber grating sensors, called the Respiratory Movement Evaluation Tool (RMET), was evaluated. The time needed to measure respiratory movement and the usability of the measurement were determined by 5 clinicians using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0 questionnaire. Thoracoabdominal movement was measured using RMET 3 times in 10 healthy subjects to evaluate intraclass correlation coefficients (ICC). The subjects were encouraged to breathe 10 times while voluntarily changing the amount of air during ventilation simultaneously with the RMET and a spirometer, and their correlations were evaluated to test validity using Pearson's product-moment correlation coefficients. The same measurements were also performed in 10 subjects with Duchenne muscular dystrophy. Real-time recordings of thoracoabdominal movements were obtained over a mean time of 374 ± 23.9 s. With QUEST 2.0, the median score of each item exceeded 3 (more or less satisfied). In healthy subjects, ICC(1,1) ranged from 0.82 to 0.99, and ICC(2,1) ranged from 0.83 to 0.97. Significant correlations were observed between the respiratory amplitudes measured with RMET, and the amount of air during ventilation was measured with a spirometer (r = 0.995, P < .001). In subjects with Duchenne muscular dystrophy, ICC(1,1) ranged from 0.87 to 0.97, and ICC(2,1) ranged from 0.84 to 0.99. The respiratory amplitudes measured with RMET correlated significantly with the amount of air during ventilation with a spirometer (r = 0.957, P < .001). We developed a novel method of quantifying respiratory movement called RMET that was feasible to use in daily clinical practice. Copyright © 2017 by Daedalus Enterprises.

Short-term Clinical Course of Knee Pain in Children and Adolescents: A Feasibility Study Using Electronic Methods of Data Collection.

PubMed

Swain, Michael S; Kamper, Steven J; Maher, Chris G; Latimer, Jane; Broderick, Carolyn; McKay, Damien; Henschke, Nicholas

2017-10-01

Musculoskeletal disorders, such as knee pain, are common in children and adolescents, but there is a lack of high quality research that evaluates the clinical course of these conditions. The objective of this study was to evaluate the feasibility of conducting a prospective study of children and adolescents with knee pain using electronic methods of data collection. Children and adolescents with knee pain that presented to primary care physiotherapy clinics were enrolled and followed-up on a weekly basis via short messaging service (SMS) until their knee pain had recovered (i.e. two consecutive weeks of no pain). Feasibility was assessed in terms of recruitment, retention and response rates to SMS and an online questionnaire. Baseline and 6-month follow-up measures included pain, disability, physical function, physical activity and health related quality of life. Kaplan-Meier survival analysis was used to estimate the median time to knee pain recovery. Thirty participants (mean age 13.0 ± 2.2 years, 53% boys) were recruited over 26 months. The overall response rate to weekly SMS follow-up was 71.3% (809 received/1135 sent). One third of participants stopped responding to SMS prior to recovery, and these participants typically had a much lower response rate during the time they remained in the study. At 6-month follow-up, 80% of the cohort completed the final online questionnaire, and 29% of participants still reported current knee pain (≥1/10 VAS). The median time for knee pain recovery was 8 weeks (95%CI: 5, 10). Electronic data collection alone seems insufficient to track pain recovery in young people and may need to be supplemented with more traditional data collection methods. Researchers should consider further measures to address slow recruitment rates and high attrition when designing large prospective studies of children and adolescents in the future. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Rectal forceps biopsy procedure in cystic fibrosis: technical aspects and patients perspective for clinical trials feasibility

PubMed Central

2013-01-01

Background Measurements of CFTR function in rectal biopsies ex vivo have been used for diagnosis and prognosis of Cystic Fibrosis (CF) disease. Here, we aimed to evaluate this procedure regarding: i) viability of the rectal specimens obtained by biopsy forceps for ex vivo bioelectrical and biochemical laboratory analyses; and ii) overall assessment (comfort, invasiveness, pain, sedation requirement, etc.) of the rectal forceps biopsy procedure from the patients perspective to assess its feasibility as an outcome measure in clinical trials. Methods We compared three bowel preparation solutions (NaCl 0.9%, glycerol 12%, mannitol), and two biopsy forceps (standard and jumbo) in 580 rectal specimens from 132 individuals (CF and non-CF). Assessment of the overall rectal biopsy procedure (obtained by biopsy forceps) by patients was carried out by telephone surveys to 75 individuals who underwent the sigmoidoscopy procedure. Results Integrity and friability of the tissue specimens correlate with their transepithelial resistance (r = −0.438 and −0.305, respectively) and are influenced by the bowel preparation solution and biopsy forceps used, being NaCl and jumbo forceps the most compatible methods with the electrophysiological analysis. The great majority of the individuals (76%) did not report major discomfort due to the short procedure time (max 15 min) and considered it relatively painless (79%). Importantly, most (88%) accept repeating it at least for one more time and 53% for more than 4 times. Conclusions Obtaining rectal biopsies with a flexible endoscope and jumbo forceps after bowel preparation with NaCl solution is a safe procedure that can be adopted for both adults and children of any age, yielding viable specimens for CFTR bioelectrical/biochemical analyses. The procedure is well tolerated by patients, demonstrating its feasibility as an outcome measure in clinical trials. PMID:23688510

Community opioid treatment perspectives on contingency management: Perceived feasibility, effectiveness, and transportability of social and financial incentives

PubMed Central

Hartzler, Bryan; Rabun, Carl

2013-01-01

Treatment community reluctance toward contingency management (CM) may be better understood by eliciting views of its feasibility, effectiveness, and transportability when social vs. financial incentives are utilized. This mixed method study involved individual staff interviews representing three personnel tiers (an executive, clinical supervisor, and two front-line clinicians) at 16 opiate treatment programs. Interviews included Likert ratings of feasibility, effectiveness, and transportability of each incentive type, and content analysis of corresponding interviewee narrative. Multi-level modeling analyses indicated that social incentives were perceived more feasible, more effective, and more transportable than financial incentives, with results pervading personnel tier. Content analysis suggested the more positive perception of social incentives was most often due to expected logistical advantages, positive impacts on patient quality-of-life, and philosophical congruence among staff. Weaker perception of financial incentives was most often influenced by concerns about costs, patient dissatisfaction, and staff philosophical incongruence. Implications for CM dissemination are discussed. PMID:23506780

Theory-driven group-based complex intervention to support self-management of osteoarthritis and low back pain in primary care physiotherapy: protocol for a cluster randomised controlled feasibility trial (SOLAS)

PubMed Central

Hurley, Deirdre A; Hall, Amanda M; Currie-Murphy, Laura; Pincus, Tamar; Kamper, Steve; Maher, Chris; McDonough, Suzanne M; Lonsdale, Chris; Walsh, Nicola E; Guerin, Suzanne; Segurado, Ricardo; Matthews, James

2016-01-01

Introduction International clinical guidelines consistently endorse the promotion of self-management (SM), including physical activity for patients with chronic low back pain (CLBP) and osteoarthritis (OA). Patients frequently receive individual treatment and advice to self-manage from physiotherapists in primary care, but the successful implementation of a clinical and cost-effective group SM programme is a key priority for health service managers in Ireland to maximise long-term outcomes and efficient use of limited and costly resources. Methods/analysis This protocol describes an assessor-blinded cluster randomised controlled feasibility trial of a group-based education and exercise intervention underpinned by self-determination theory designed to support an increase in SM behaviour in patients with CLBP and OA in primary care physiotherapy. The primary care clinic will be the unit of randomisation (cluster), with each clinic randomised to 1 of 2 groups providing the Self-management of Osteoarthritis and Low back pain through Activity and Skills (SOLAS) intervention or usual individual physiotherapy. Patients are followed up at 6 weeks, 2 and 6 months. The primary outcomes are the (1) acceptability and demand of the intervention to patients and physiotherapists, (2) feasibility and optimal study design/procedures and sample size for a definitive trial. Secondary outcomes include exploratory analyses of: point estimates, 95% CIs, change scores and effect sizes in physical function, pain and disability outcomes; process of change in target SM behaviours and selected mediators; and the cost of the intervention to inform a definitive trial. Ethics/dissemination This feasibility trial protocol was approved by the UCD Human Research Ethics—Sciences Committee (LS-13-54 Currie-Hurley) and research access has been granted by the Health Services Executive Primary Care Research Committee in January 2014. The study findings will be disseminated to the research, clinical and health service communities through publication in peer-reviewed journals, presentation at national and international academic and clinical conferences. Trial registration number ISRCTN 49875385; Pre-results. PMID:26801470

Improving the healthcare response to domestic violence and abuse in sexual health clinics: feasibility study of a training, support and referral intervention.

PubMed

Sohal, Alex Hardip; Pathak, Neha; Blake, Sarah; Apea, Vanessa; Berry, Judith; Bailey, Jayne; Griffiths, Chris; Feder, Gene

2018-03-01

Sexual health and gynaecological problems are the most consistent and largest physical health differences between abused and non-abused female populations. Sexual health services are well placed to identify and support patients experiencing domestic violence and abuse (DVA). Most sexual health professionals have had minimal DVA training despite English National Institute for Health and Care Excellence recommendations. We sought to determine the feasibility of an evidence-based complex DVA training intervention in female sexual health walk-in services (IRIS ADViSE: Identification and Referral to Improve Safety whilst Assessing Domestic Violence in Sexual Health Environments). An adaptive mixed method pilot study in the female walk-in service of two sexual health clinics. Following implementation and evaluation at site 1, the intervention was refined before implementation at site 2. The intervention comprised electronic prompts, multidisciplinary training sessions, clinic materials and simple referral pathways to IRIS ADViSE advocate-educators (AEs). The pilot lasted 7 weeks at site 1 and 12 weeks at site 2. Feasibility outcomes were to assign a supportive DVA clinical lead, an IRIS ADViSE AE employed by a local DVA service provider, adapt electronic records, develop local referral pathways, assess whether enquiry, identification and referral rates were measurable. Both sites achieved all feasibility outcomes: appointing a supportive DVA clinical lead and IRIS ADViSE AE, establishing links with a local DVA provider, adapting electronic records, developing local referral pathways and rates of enquiry, identification and referral were found to be measurable. Site 1: 10% enquiry rate (n=267), 4% identification rate (n=16) and eight AE referrals. Site 2: 61% enquiry rate (n=1090), a 7% identification rate (n=79) and eight AE referrals. IRIS ADViSE can be successfully developed and implemented in sexual health clinics. It fulfils the unmet need for DVA training. Longer-term evaluation is recommended. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Multimodality approach to classifying hand utilization for the clinical breast examination.

PubMed

Laufer, Shlomi; Cohen, Elaine R; Maag, Anne-Lise D; Kwan, Calvin; Vanveen, Barry; Pugh, Carla M

2014-01-01

The clinical breast examination (CBE) is performed to detect breast pathology. However, little is known regarding clinical technique and how it relates to diagnostic accuracy. We sought to quantify breast examination search patterns and hand utilization with a new data collection and analysis system. Participants performed the CBE while the sensor mapping and video camera system collected performance data. From this data, algorithms were developed that measured the number of hands used during the exam and active examination time. This system is a feasible and reliable method to collect new information on CBE techniques.

Acceptability and feasibility of phone follow-up with a semiquantitative urine pregnancy test after medical abortion in Moldova and Uzbekistan.

PubMed

Platais, Ingrida; Tsereteli, Tamar; Comendant, Rodica; Kurbanbekova, Dilfuza; Winikoff, Beverly

2015-02-01

To evaluate the feasibility and acceptability of phone follow-up with a home semiquantitative pregnancy test and standardized checklist, and compare the alternative method of follow-up with in-clinic follow-up after medical abortion. Two thousand four hundred women undergoing medical abortion with mifepristone and misoprostol in Moldova and Uzbekistan were randomized to phone or clinic follow-up. All women in the clinic group returned to the clinic 2 weeks later. Women randomized to phone follow-up used a semiquantitative pregnancy test at the initial visit and repeated the test at home 2 weeks later when they also filled out a symptom checklist. Women were called at 2 weeks to review the test results and checklist. Participants who screened "positive" were referred to clinic to verify abortion completion. Most women in the phone group were successfully contacted on the phone (97.6%). Staff were unable to contact one woman in the phone follow-up group, and all women in clinic group returned to the clinic. The ongoing pregnancy rate was similar in both groups (0.4-0.6%), and the semiquantitative pregnancy test identified all ongoing pregnancies in the phone follow-up group. Women in the phone group found the test and checklist easy to use, and most (76.1%) preferred phone follow-up in the future. Overall, 92.8% of women in the phone group did not undergo in-clinic follow-up. Phone follow-up with a semiquantitative urine pregnancy test and symptom checklist is a feasible and a highly effective approach in identifying ongoing pregnancy after medical abortion. The semiquantitative pregnancy test can make home follow-up after medical abortion possible for many women and provide reassurance that ongoing pregnancies will be detected. Copyright © 2015 Elsevier Inc. All rights reserved.

Evaluation of A Novel Information-Sharing Instrument for Home-Based Palliative Care

PubMed Central

Sawada, Koichiro; Shimada, Masanari; Kadoya, Shinichi; Endo, Naoki; Ishiguro, Kaname; Takashima, Rumi; Amemiya, Yoko; Fujikawa, Yasunaga; Ikezaki, Tomoaki; Takeuchi, Miyako; Kitazawa, Hidenori; Iida, Hiroyuki; Koseki, Shiro; Morita, Tatsuya; Sasaki, Koji; Kashii, Tatsuhiko; Murakami, Nozomu

2015-01-01

Aim: To examine the feasibility and usefulness of a novel region-based pathway: the Regional Referral Clinical Pathway for Home-Based Palliative Care. Method: This was a feasibility study to evaluate the frequency of variances and the perceived usefulness of pathway using in-depth interviews. All patients with cancer referred to the palliative care team between 2011 and 2013 and received home care services were enrolled. Result: A total of 44 patients were analyzed, and pathway was completed in all the patients. The target outcome was achieved in 61.4% while some variances occurred in 54.5%. Nine categories were identified as the usefulness of the pathway, such as reviewing and sharing information and promoting communication, education, motivation, and relationships. Conclusion: This novel pathway is feasible and seems to be useful. PMID:24814723

Adaptation and Feasibility Study of a Digital Health Program to Prevent Diabetes among Low-Income Patients: Results from a Partnership between a Digital Health Company and an Academic Research Team

PubMed Central

McDermott, Kelly; Tieu, Lina; Rios, Christina; Gibson, Eliza; Sweet, Cynthia Castro; Payne, Mike

2016-01-01

Background. The feasibility of digital health programs to prevent and manage diabetes in low-income patients has not been adequately explored. Methods. Researchers collaborated with a digital health company to adapt a diabetes prevention program for low-income prediabetes patients at a large safety net clinic. We conducted focus groups to assess patient perspectives, revised lessons for improved readability and cultural relevance to low-income and Hispanic patients, conducted a feasibility study of the adapted program in English and Spanish speaking cohorts, and implemented real-time adaptations to the program for commercial use and for a larger trial of in multiple safety net clinics. Results. The majority of focus group participants were receptive to the program. We modified the curriculum to a 5th-grade reading level and adapted content based on patient feedback. In the feasibility study, 54% of eligible contacted patients expressed interest in enrolling (n = 23). Although some participants' computer access and literacy made registration challenging, they were highly satisfied and engaged (80% logged in at least once/week). Conclusions. Underserved prediabetic patients displayed high engagement and satisfaction with a digital diabetes prevention program despite lower digital literacy skills. The collaboration between researchers and a digital health company enabled iterative improvements in technology implementation to address challenges in low-income populations. PMID:27868070

Delivering perinatal depression care in a rural obstetric setting: a mixed methods study of feasibility, acceptability and effectiveness.

PubMed

Bhat, Amritha; Reed, Susan; Mao, Johnny; Vredevoogd, Mindy; Russo, Joan; Unger, Jennifer; Rowles, Roger; Unützer, Jürgen

2017-09-07

Universal screening for depression during pregnancy and postpartum is recommended, yet mental health treatment and follow-up rates among screen-positive women in rural settings are low. We studied the feasibility, acceptability and effectiveness of perinatal depression treatment integrated into a rural obstetric setting. We conducted an open treatment study of a screening and intervention program modified from the Depression Attention for Women Now (DAWN) Collaborative Care model in a rural obstetric clinic. Depression screen-positive pregnant and postpartum women received problem-solving therapy (PST) with or without antidepressants. A care manager coordinated communication between patient, obstetrician and psychiatric consultant. We measured change in the Patient Health Questionnaire 9 (PHQ-9) score. We used surveys and focus groups to measure patient and provider satisfaction and analyzed focus groups using qualitative analysis. The intervention was well accepted by providers and patients, based on survey and focus group data. Feasibility was also evidenced by recruitment (87.1%) and retention (92.6%) rates and depression outcomes (64% with >50% improvement in PHQ 9) which were comparable to clinical trials in similar urban populations. Conclusions for practice: DAWN Collaborative Care modified for treatment of perinatal depression in a rural obstetric setting is feasible and acceptable. Behavioral health services integrated into rural obstetric settings could improve care for perinatal depression.

Native T1 mapping of the heart - a pictorial review.

PubMed

Germain, Philippe; El Ghannudi, Soraya; Jeung, Mi-Young; Ohlmann, Patrick; Epailly, Eric; Roy, Catherine; Gangi, Afshin

2014-01-01

T1 mapping is now a clinically feasible method, providing pixel-wise quantification of the cardiac structure's T1 values. Beyond focal lesions, well depicted by late gadolinium enhancement sequences, it has become possible to discriminate diffuse myocardial alterations, previously not assessable by noninvasive means. The strength of this method includes the high reproducibility and immediate clinical applicability, even without the use of contrast media injection (native or pre-contrast T1). The two most important determinants of native T1 augmentation are (1) edema related to tissue water increase (recent infarction or inflammation) and (2) interstitial space increase related to fibrosis (infarction scar, cardiomyopathy) or to amyloidosis. Conversely, lipid (Anderson-Fabry) or iron overload diseases are responsible for T1 reduction. In this pictorial review, the main features provided by native T1 mapping are discussed and illustrated, with a special focus on the awaited clinical purpose of this unique, promising new method.

Gaussian processes for personalized e-health monitoring with wearable sensors.

PubMed

Clifton, Lei; Clifton, David A; Pimentel, Marco A F; Watkinson, Peter J; Tarassenko, Lionel

2013-01-01

Advances in wearable sensing and communications infrastructure have allowed the widespread development of prototype medical devices for patient monitoring. However, such devices have not penetrated into clinical practice, primarily due to a lack of research into "intelligent" analysis methods that are sufficiently robust to support large-scale deployment. Existing systems are typically plagued by large false-alarm rates, and an inability to cope with sensor artifact in a principled manner. This paper has two aims: 1) proposal of a novel, patient-personalized system for analysis and inference in the presence of data uncertainty, typically caused by sensor artifact and data incompleteness; 2) demonstration of the method using a large-scale clinical study in which 200 patients have been monitored using the proposed system. This latter provides much-needed evidence that personalized e-health monitoring is feasible within an actual clinical environment, at scale, and that the method is capable of improving patient outcomes via personalized healthcare.

Measurement properties and feasibility of clinical tests to assess sit-to-stand/stand-to-sit tasks in subjects with neurological disease: a systematic review

PubMed Central

Silva, Paula F. S.; Quintino, Ludmylla F.; Franco, Juliane; Faria, Christina D. C. M.

2014-01-01

Background Subjects with neurological disease (ND) usually show impaired performance during sit-to-stand and stand-to-sit tasks, with a consequent reduction in their mobility levels. Objective To determine the measurement properties and feasibility previously investigated for clinical tests that evaluate sit-to-stand and stand-to-sit in subjects with ND. Method A systematic literature review following the PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) protocol was performed. Systematic literature searches of databases (MEDLINE/SCIELO/LILACS/PEDro) were performed to identify relevant studies. In all studies, the following inclusion criteria were assessed: investigation of any measurement property or the feasibility of clinical tests that evaluate sit-to-stand and stand-to-sit tasks in subjects with ND published in any language through December 2012. The COSMIN checklist was used to evaluate the methodological quality of the included studies. Results Eleven studies were included. The measurement properties/feasibility were most commonly investigated for the five-repetition sit-to-stand test, which showed good test-retest reliability (Intraclass Correlation Coefficient:ICC=0.94-0.99) for subjects with stroke, cerebral palsy and dementia. The ICC values were higher for this test than for the number of repetitions in the 30-s test. The five-repetition sit-to-stand test also showed good inter/intra-rater reliabilities (ICC=0.97-0.99) for stroke and inter-rater reliability (ICC=0.99) for subjects with Parkinson disease and incomplete spinal cord injury. For this test, the criterion-related validity for subjects with stroke, cerebral palsy and incomplete spinal cord injury was, in general, moderate (correlation=0.40-0.77), and the feasibility and safety were good for subjects with Alzheimer's disease. Conclusions The five-repetition sit-to-stand test was used more often in subjects with ND, and most of the measurement properties were investigated and showed adequate results. PMID:24839043

Exploring the Utility of Narrative Analysis in Diagnostic Decision Making: Picture-Bound Reference, Elaboration, and Fetal Alcohol Spectrum Disorders

ERIC Educational Resources Information Center

Thorne, John C.; Coggins, Truman E.; Olson, Heather Carmichael; Astley, Susan J.

2007-01-01

Purpose: To evaluate classification accuracy and clinical feasibility of a narrative analysis tool for identifying children with a fetal alcohol spectrum disorder (FASD). Method: Picture-elicited narratives generated by 16 age-matched pairs of school-aged children (FASD vs. typical development [TD]) were coded for semantic elaboration and…

Interpersonal Psychotherapy with Pregnant Adolescents: Two Pilot Studies

ERIC Educational Resources Information Center

Miller, Lisa; Gur, Merav; Shanok, Arielle; Weissman, Myrna

2008-01-01

The objective of this study was to test the feasibility, acceptability and helpfulness of group Interpersonal Psychotherapy (IPT-PA) for depression in pregnant adolescents. Method: Two open clinical trials were conducted of IPT-PA delivered in group format in a New York City public school for pregnant girls. Study 1 tests IPT-PA for management of…

Practical Disk Diffusion Test for Detecting Group B Streptococcus with Reduced Penicillin Susceptibility▿

PubMed Central

Kimura, Kouji; Wachino, Jun-ichi; Kurokawa, Hiroshi; Suzuki, Satowa; Yamane, Kunikazu; Shibata, Naohiro; Arakawa, Yoshichika

2009-01-01

Although group B streptococcus (GBS) has been considered to be uniformly susceptible to β-lactams, the presence of GBS with reduced penicillin susceptibility (PRGBS) was recently confirmed genetically. We developed a feasible and reliable method for screening PRGBS in clinical microbiology laboratories using a combination of ceftibuten, oxacillin, and ceftizoxime disks. PMID:19812274

Practical disk diffusion test for detecting group B streptococcus with reduced penicillin susceptibility.

PubMed

Kimura, Kouji; Wachino, Jun-Ichi; Kurokawa, Hiroshi; Suzuki, Satowa; Yamane, Kunikazu; Shibata, Naohiro; Arakawa, Yoshichika

2009-12-01

Although group B streptococcus (GBS) has been considered to be uniformly susceptible to beta-lactams, the presence of GBS with reduced penicillin susceptibility (PRGBS) was recently confirmed genetically. We developed a feasible and reliable method for screening PRGBS in clinical microbiology laboratories using a combination of ceftibuten, oxacillin, and ceftizoxime disks.

A Pharmacotherapy Algorithm for Stabilization and Maintenance of Pediatric Bipolar Disorder

ERIC Educational Resources Information Center

Pavuluri, Mani N.; Henry, David B.; Devineni, Bhargavi; Carbray, Julie A.; Naylor, Michael W.; Janicak, Philip G.

2004-01-01

Objective: To assess the feasibility and effectiveness of an evidence-based pharmacotherapy algorithm in the treatment of pediatric bipolar disorder. Method: The study reports the results of a study of 64 bipolar type I subjects who were treated according to an algorithm developed in our specialty clinic. All subjects had been diagnosed using the…

Brief Screening and Intervention for Alcohol and Drug Use in a College Student Health Clinic: Feasibility, Implementation, and Outcomes

ERIC Educational Resources Information Center

Amaro, Hortensia; Reed, Elizabeth; Rowe, Erin; Picci, Jennifer; Mantella, Philomena; Prado, Guillermo

2010-01-01

Objective: Evaluation of the Brief Alcohol Screen and Intervention in College Students (BASICS) in a university primary care setting. Participants/Methods: Undergraduates (N = 449) participated in BASICS and electronic surveys assessing frequency/quantity of alcohol and drug use, psychosocial and mental health outcomes, and demographic…

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.

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

NASA Astrophysics Data System (ADS)

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

1998-05-01

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

Integrating CHWs as Part of the Team Leading Diabetes Group Visits: A Randomized Controlled Feasibility Study.

PubMed

Vaughan, Elizabeth M; Johnston, Craig A; Cardenas, Victor J; Moreno, Jennette P; Foreyt, John P

2017-12-01

Purpose The purpose of the study was to evaluate the feasibility of integrating Community Health Workers (CHWs) as part of the team leading diabetes group visits. Methods This was a randomized controlled study that integrated CHWs as part of the team leading diabetes group visits for low-income Hispanic adults (n = 50). Group visits met for 3 hours each month for a 6-month duration. Main measures included baseline and 6-month clinical outcomes (ie, A1C, lipids), concordance with 8 standard of care guidelines (ie, screens for cervical, breast, and colon cancer) from the US Preventive Task Force and American Diabetes Association, and participant acceptability. Results Compared to control participants, the intervention group resulted in significantly better clinical outcomes or guideline concordance for the following areas: target A1C levels, retinal eye exams, diabetes foot exams, mammograms, and urine microalbumin. Significantly more individuals in the control group gained weight, whereas a greater number of participants in the intervention group lost weight. Intervention participants found the group visits highly acceptable. Conclusions Integrating CHWs as part a comprehensive diabetes group visit program is a feasible and effective system-level intervention to improve glycemic control and achieve guideline concordance.

Optical ensemble analysis of intraocular lens performance through a simulated clinical trial with ZEMAX.

PubMed

Zhao, Huawei

2009-01-01

A ZEMAX model was constructed to simulate a clinical trial of intraocular lenses (IOLs) based on a clinically oriented Monte Carlo ensemble analysis using postoperative ocular parameters. The purpose of this model is to test the feasibility of streamlining and optimizing both the design process and the clinical testing of IOLs. This optical ensemble analysis (OEA) is also validated. Simulated pseudophakic eyes were generated by using the tolerancing and programming features of ZEMAX optical design software. OEA methodology was verified by demonstrating that the results of clinical performance simulations were consistent with previously published clinical performance data using the same types of IOLs. From these results we conclude that the OEA method can objectively simulate the potential clinical trial performance of IOLs.

A European inventory of common electronic health record data elements for clinical trial feasibility

PubMed Central

2014-01-01

Background Clinical studies are a necessity for new medications and therapies. Many studies, however, struggle to meet their recruitment numbers in time or have problems in meeting them at all. With increasing numbers of electronic health records (EHRs) in hospitals, huge databanks emerge that could be utilized to support research. The Innovative Medicine Initiative (IMI) funded project ‘Electronic Health Records for Clinical Research’ (EHR4CR) created a standardized and homogenous inventory of data elements to support research by utilizing EHRs. Our aim was to develop a Data Inventory that contains elements required for site feasibility analysis. Methods The Data Inventory was created in an iterative, consensus driven approach, by a group of up to 30 people consisting of pharmaceutical experts and informatics specialists. An initial list was subsequently expanded by data elements of simplified eligibility criteria from clinical trial protocols. Each element was manually reviewed by pharmaceutical experts and standard definitions were identified and added. To verify their availability, data exports of the source systems at eleven university hospitals throughout Europe were conducted and evaluated. Results The Data Inventory consists of 75 data elements that, on the one hand are frequently used in clinical studies, and on the other hand are available in European EHR systems. Rankings of data elements were created from the results of the data exports. In addition a sub-list was created with 21 data elements that were separated from the Data Inventory because of their low usage in routine documentation. Conclusion The data elements in the Data Inventory were identified with the knowledge of domain experts from pharmaceutical companies. Currently, not all information that is frequently used in site feasibility is documented in routine patient care. PMID:24410735

A gEUD-based inverse planning technique for HDR prostate brachytherapy: Feasibility study

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

Giantsoudi, D.; Department of Radiation Oncology, Francis H. Burr Proton Therapy Center, Boston, Massachusetts 02114; Baltas, D.

2013-04-15

Purpose: The purpose of this work was to study the feasibility of a new inverse planning technique based on the generalized equivalent uniform dose for image-guided high dose rate (HDR) prostate cancer brachytherapy in comparison to conventional dose-volume based optimization. Methods: The quality of 12 clinical HDR brachytherapy implants for prostate utilizing HIPO (Hybrid Inverse Planning Optimization) is compared with alternative plans, which were produced through inverse planning using the generalized equivalent uniform dose (gEUD). All the common dose-volume indices for the prostate and the organs at risk were considered together with radiobiological measures. The clinical effectiveness of the differentmore » dose distributions was investigated by comparing dose volume histogram and gEUD evaluators. Results: Our results demonstrate the feasibility of gEUD-based inverse planning in HDR brachytherapy implants for prostate. A statistically significant decrease in D{sub 10} or/and final gEUD values for the organs at risk (urethra, bladder, and rectum) was found while improving dose homogeneity or dose conformity of the target volume. Conclusions: Following the promising results of gEUD-based optimization in intensity modulated radiation therapy treatment optimization, as reported in the literature, the implementation of a similar model in HDR brachytherapy treatment plan optimization is suggested by this study. The potential of improved sparing of organs at risk was shown for various gEUD-based optimization parameter protocols, which indicates the ability of this method to adapt to the user's preferences.« less

Analytical modeling and feasibility study of a multi-GPU cloud-based server (MGCS) framework for non-voxel-based dose calculations.

PubMed

Neylon, J; Min, Y; Kupelian, P; Low, D A; Santhanam, A

2017-04-01

In this paper, a multi-GPU cloud-based server (MGCS) framework is presented for dose calculations, exploring the feasibility of remote computing power for parallelization and acceleration of computationally and time intensive radiotherapy tasks in moving toward online adaptive therapies. An analytical model was developed to estimate theoretical MGCS performance acceleration and intelligently determine workload distribution. Numerical studies were performed with a computing setup of 14 GPUs distributed over 4 servers interconnected by a 1 Gigabits per second (Gbps) network. Inter-process communication methods were optimized to facilitate resource distribution and minimize data transfers over the server interconnect. The analytically predicted computation time predicted matched experimentally observations within 1-5 %. MGCS performance approached a theoretical limit of acceleration proportional to the number of GPUs utilized when computational tasks far outweighed memory operations. The MGCS implementation reproduced ground-truth dose computations with negligible differences, by distributing the work among several processes and implemented optimization strategies. The results showed that a cloud-based computation engine was a feasible solution for enabling clinics to make use of fast dose calculations for advanced treatment planning and adaptive radiotherapy. The cloud-based system was able to exceed the performance of a local machine even for optimized calculations, and provided significant acceleration for computationally intensive tasks. Such a framework can provide access to advanced technology and computational methods to many clinics, providing an avenue for standardization across institutions without the requirements of purchasing, maintaining, and continually updating hardware.

On the feasibility of automatic detection of range deviations from in-beam PET data

NASA Astrophysics Data System (ADS)

Helmbrecht, S.; Santiago, A.; Enghardt, W.; Kuess, P.; Fiedler, F.

2012-03-01

In-beam PET is a clinically proven method for monitoring ion beam cancer treatment. The objective is predominantly the verification of the range of the primary particles. Due to different processes leading to dose and activity, evaluation is done by comparing measured data to simulated. Up to now, the comparison is performed by well-trained observers (clinicians, physicists). This process is very time consuming and low in reproducibility. However, an automatic method is desirable. A one-dimensional algorithm for range comparison has been enhanced and extended to three dimensions. System-inherent uncertainties are handled by means of a statistical approach. To test the method, a set of data was prepared. Distributions of β+-activity calculated from treatment plans were compared to measurements performed in the framework of the German Heavy Ion Tumor Therapy Project at GSI Helmholtz Centre for Heavy Ion Research, Darmstadt, Germany. Artificial range deviations in the simulations served as test objects for the algorithm. Range modifications of different depth (4, 6 and 10 mm water equivalent path length) can be detected. Even though the sensitivity and specificity of a visual evaluation are higher, the method is feasible as the basis for the selection of patients from the data pool for retrospective evaluation of treatment and treatment plans and correlation with follow-up data. Furthermore, it can be used for the development of an assistance tool for a clinical application.

Magnetic resonance angiography of fetal vasculature at 3.0 T.

PubMed

Neelavalli, Jaladhar; Krishnamurthy, Uday; Jella, Pavan K; Mody, Swati S; Yadav, Brijesh K; Hendershot, Kelly; Hernandez-Andrade, Edgar; Yeo, Lami; Cabrera, Maria D; Haacke, Ewart M; Hassan, Sonia S; Romero, Roberto

2016-12-01

Magnetic resonance angiography has not been used much previously for visualizing fetal vessels in utero for reasons that include a contraindication for the use of exogenous contrast agents, maternal respiratory motion and fetal motion. In this work, we report the feasibility of using an appropriately modified clinical time-of-flight magnetic resonance imaging sequence for non-contrast angiography of human fetal and placental vessels at 3.0 T. Using this 2D angiography technique, it is possible to visualize fetal vascular networks in late pregnancy. • 3D-visualization of fetal vasculature is feasible using non-contrast MRA at 3.0 T. • Visualization of placental vasculature is also possible with this method. • Fetal MRA can serve as a vascular localizer for quantitative MRI studies. • This method can be extended to 1.5 T.

Using random telephone sampling to recruit generalizable samples for family violence studies.

PubMed

Slep, Amy M Smith; Heyman, Richard E; Williams, Mathew C; Van Dyke, Cheryl E; O'Leary, Susan G

2006-12-01

Convenience sampling methods predominate in recruiting for laboratory-based studies within clinical and family psychology. The authors used random digit dialing (RDD) to determine whether they could feasibly recruit generalizable samples for 2 studies (a parenting study and an intimate partner violence study). RDD screen response rate was 42-45%; demographics matched those in the 2000 U.S. Census, with small- to medium-sized differences on race, age, and income variables. RDD respondents who qualified for, but did not participate in, the laboratory study of parents showed small differences on income, couple conflicts, and corporal punishment. Time and cost are detailed, suggesting that RDD may be a feasible, effective method by which to recruit more generalizable samples for in-laboratory studies of family violence when those studies have sufficient resources. (c) 2006 APA, all rights reserved.

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

PubMed Central

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

2013-01-01

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

Feasibility of imaging superficial palmar arch using micro-ultrasound, 7T and 3T magnetic resonance imaging.

PubMed

Pruzan, Alison N; Kaufman, Audrey E; Calcagno, Claudia; Zhou, Yu; Fayad, Zahi A; Mani, Venkatesh

2017-02-28

To demonstrate feasibility of vessel wall imaging of the superficial palmar arch using high frequency micro-ultrasound, 7T and 3T magnetic resonance imaging (MRI). Four subjects (ages 22-50 years) were scanned on a micro-ultrasound system with a 45-MHz transducer (Vevo 2100, VisualSonics). Subjects' hands were then imaged on a 3T clinical MR scanner (Siemens Biograph MMR) using an 8-channel special purpose phased array carotid coil. Lastly, subjects' hands were imaged on a 7T clinical MR scanner (Siemens Magnetom 7T Whole Body Scanner) using a custom built 8-channel transmit receive carotid coil. All three imaging modalities were subjectively analyzed for image quality and visualization of the vessel wall. Results of this very preliminary study indicated that vessel wall imaging of the superficial palmar arch was feasible with a whole body 7T and 3T MRI in comparison with micro-ultrasound. Subjective analysis of image quality (1-5 scale, 1: poorest, 5: best) from B mode, ultrasound, 3T SPACE MRI and 7T SPACE MRI indicated that the image quality obtained at 7T was superior to both 3T MRI and micro-ultrasound. The 3D SPACE sequence at both 7T and 3T MRI with isotropic voxels allowed for multi-planar reformatting of images and allowed for less operator dependent results as compared to high frequency micro-ultrasound imaging. Although quantitative analysis revealed that there was no significant difference between the three methods, the 7T Tesla trended to have better visibility of the vessel and its wall. Imaging of smaller arteries at the 7T is feasible for evaluating atherosclerosis burden and may be of clinical relevance in multiple diseases.

Integrative rehabilitation of elderly stroke survivors: The design and evaluation of the BrightArm™

PubMed Central

Rabin, Bryan A.; Burdea, Grigore C.; Roll, Doru T.; Hundal, Jasdeep S.; Damiani, Frank; Pollack, Simcha

2011-01-01

Purpose To describe the development of the BrightArm upper extremity rehabilitation system, and to determine its clinical feasibility with older hemiplegic patients. Method The BrightArm adjusted arm gravity loading through table tilting. Patients wore an arm support that sensed grasp strength and communicated wirelessly with a personal computer. Games were written to improve cognitive, psychosocial and the upper extremity motor function and adapted automatically to each patient. The system underwent feasibility trials spanning 6 weeks. Participants were evaluated pre-therapy, post-therapy, and at 6 weeks follow-up using standardized clinical measures. Computerized measures of supported arm reach and game performance were stored on a remote server. Results Five participants had clinically significant improvements in their active range of shoulder movement, shoulder strength, grasp strength, and their ability to focus. Several participants demonstrated substantially higher arm function (measured with the Fugl-Meyer test) and two were less-depressed (measured with the Becks Depression Inventory, Second Edition). The BrightArm technology was well-accepted by the participants, who gave it an overall subjective rating of 4.1 on a 5 point Likert scale. Conclusions Given these preliminary findings, it will be beneficial to evaluate the BrightArm through controlled clinical trials and to investigate its application to other clinical populations. PMID:22107353

Clinical feasibility of exercise-based A-V interval optimization for cardiac resynchronization: a pilot study.

PubMed

Choudhuri, Indrajit; MacCarter, Dean; Shaw, Rachael; Anderson, Steve; St Cyr, John; Niazi, Imran

2014-11-01

One-third of eligible patients fail to respond to cardiac resynchronization therapy (CRT). Current methods to "optimize" the atrio-ventricular (A-V) interval are performed at rest, which may limit its efficacy during daily activities. We hypothesized that low-intensity cardiopulmonary exercise testing (CPX) could identify the most favorable physiologic combination of specific gas exchange parameters reflecting pulmonary blood flow or cardiac output, stroke volume, and left atrial pressure to guide determination of the optimal A-V interval. We assessed relative feasibility of determining the optimal A-V interval by three methods in 17 patients who underwent optimization of CRT: (1) resting echocardiographic optimization (the Ritter method), (2) resting electrical optimization (intrinsic A-V interval and QRS duration), and (3) during low-intensity, steady-state CPX. Five sequential, incremental A-V intervals were programmed in each method. Assessment of cardiopulmonary stability and potential influence on the CPX-based method were assessed. CPX and determination of a physiological optimal A-V interval was successfully completed in 94.1% of patients, slightly higher than the resting echo-based approach (88.2%). There was a wide variation in the optimal A-V delay determined by each method. There was no observed cardiopulmonary instability or impact of the implant procedure that affected determination of the CPX-based optimized A-V interval. Determining optimized A-V intervals by CPX is feasible. Proposed mechanisms explaining this finding and long-term impact require further study. ©2014 Wiley Periodicals, Inc.

Blood Pressure Measurement: Clinic, Home, Ambulatory, and Beyond

PubMed Central

Drawz, Paul E.; Abdalla, Mohamed; Rahman, Mahboob

2014-01-01

Blood pressure has traditionally been measured in the clinic setting using the auscultory method and a mercury sphygmomanometer. Technological advances have led to improvements in measuring clinic blood pressure and allowed for measuring blood pressures outside the clinic. This review outlines various methods for evaluating blood pressure and the clinical utility of each type of measurement. Home blood pressures and 24 hour ambulatory blood pressures have improved our ability to evaluate risk for target organ damage and hypertension related morbidity and mortality. Measuring home blood pressures may lead to more active participation in health care by patients and has the potential to improve blood pressure control. Ambulatory blood pressure monitoring enables the measuring nighttime blood pressures and diurnal changes, which may be the most accurate predictors of risk associated with elevated blood pressure. Additionally, reducing nighttime blood pressure is feasible and may be an important component of effective antihypertensive therapy. Finally, estimating central aortic pressures and pulse wave velocity are two of the newer methods for assessing blood pressure and hypertension related target organ damage. PMID:22521624

[Enhanced Recovery after Surgery from Theory to Practice
What do We Need to Do?

PubMed

Che, Guowei; Liu, Lunxu; Zhou, Qinghua

2017-04-20

Enhanced recovery after surgery (ERAS) is a paradigm shift in perioperative care, resulting in substantial improvements in clinical outcomes, shorter length of hospital stay and cost savings. But the current ERAS either by application of breadth or depth is not enough, why? The main reason is the lack of "operability, evaluation, repetition" ERAS protocol and suitable for clinical extensive application protocol. How to form the clinical available protocol? Operational mainly refers to the clinical scheme is simple and feasible, and protocol compliance is good; Evaluate refers to the methods used before, during and after are the objective evaluation criteria and plan; Repeatable is clinical scheme repeatability in the process of single or multiple center.

Acute Stroke and Obstruction of the Extracranial Carotid Artery Combined with Intracranial Tandem Occlusion: Results of Interventional Revascularization

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

Lescher, Stephanie, E-mail: stephanie.lescher@kgu.de; Czeppan, Katja; Porto, Luciana

PurposeDue to high thrombus load, acute stroke patients with tandem obstructions of the extra- and intracranial carotid arteries or the middle cerebral artery show a very limited response to systemic thrombolysis. Interventional treatment with mechanical thrombectomy—often in combination with acute stenting of underlying atherosclerotic stenosis or dissection—is increasingly used. It has been shown that such complex interventions are technically feasible. The lack of optimal management strategies and clinical data encouraged us to review our acute stroke interventions in patient with anterior circulation tandem lesions to determine lesion patterns, interventional approaches, and angiographic or clinical outcomes.Patients and MethodsWe retrospectively analyzed amore » series of 39 consecutive patients with intracranial vessel occlusion of the anterior circulation simultaneously presenting with high-grade cervical internal carotid artery (ICA) stenosis or occlusion.ResultsEmergency ICA stent implantation was technically feasible in all patients, and intracranial recanalization with TICI ≥ 2b was reached in a large number of patients (64 %). Good clinical outcomes (mRS ≤ 2 at 3 months) were achieved in one third of the patients (36 %). Symptomatic hemorrhages occurred in four patients (10 %). Mortality was 10 %.ConclusionEndovascular recanalization of acute cervical carotid artery occlusion was technically feasible in all patients, and resulted in high extra- and intracranial revascularization rates. A trend for favorable clinical outcome was seen in a higher TICI score, younger age, good collateral status, and combined IV rTPA and endovascular therapy.« less

A novel pediatric treatment intensity score: development and feasibility in heart failure patients with ventricular assist devices.

PubMed

May, Lindsay J; Ploutz, Michelle; Hollander, Seth A; Reinhartz, Olaf; Almond, Christopher S; Chen, Sharon; Maeda, Katsuhide; Kaufman, Beth D; Yeh, Justin; Rosenthal, David N

2015-04-01

The evolution of pharmacologic therapies and mechanical support including ventricular assist devices (VADs) has broadened the scope of care available to children with advanced heart failure. At the present time, there are only limited means of quantifying disease severity or the concomitant morbidity for this population. This study describes the development of a novel pediatric treatment intensity score (TIS), designed to quantify the burden of illness and clinical trajectory in children on VAD support. There were 5 clinical domains assessed: nutrition, respiratory support, activity level, cardiovascular medications, and care environment. A scale was developed through expert consensus. Higher scores indicate greater morbidity as reflected by intensity of medical management. To evaluate feasibility and face validity, the TIS was applied retrospectively to a subset of pediatric inpatients with VADs. The Bland-Altman method was used to assess limits of agreement. The study comprised 39 patients with 42 implantations. Bland-Altman interobserver and intraobserver comparisons showed good agreement (mean differences in scores of 0.02, limits of agreement ±0.12). Trends in TIS were concordant with the overall clinical impression of improvement. Scores remained ≥0.6 preceding VAD implantation and peaked at 0.71 3 days after VAD implantation. We describe a pediatric VAD scoring tool, to assess global patient morbidity and clinical recovery. We demonstrate feasibility of using this TIS in a test population of inpatients on VAD support. Copyright © 2015 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.

The feasibility of cell phone based electronic diaries for STI/HIV research.

PubMed

Hensel, Devon J; Fortenberry, James D; Harezlak, Jaroslaw; Craig, Dorothy

2012-06-12

Self-reports of sensitive, socially stigmatized or illegal behavior are common in STI/HIV research, but can raise challenges in terms of data reliability and validity. The use of electronic data collection tools, including ecological momentary assessment (EMA), can increase the accuracy of this information by allowing a participant to self-administer a survey or diary entry, in their own environment, as close to the occurrence of the behavior as possible. In this paper, we evaluate the feasibility of using cell phone-based EMA as a tool for understanding sexual risk and STI among adult men and women. As part of a larger prospective clinical study on sexual risk behavior and incident STI in clinically recruited adult men and women, using study-provided cell phones, participants (N = 243) completed thrice-daily EMA diaries monitoring individual and partner-specific emotional attributes, non-sexual activities, non-coital or coital sexual behaviors, and contraceptive behaviors. Using these data, we assess feasibility in terms of participant compliance, behavior reactivity, general method acceptability and method efficacy for capturing behaviors. Participants were highly compliant with diary entry protocol and schedule: over the entire 12 study weeks, participants submitted 89.7% (54,914/61,236) of the expected diary entries, with an average of 18.86 of the 21 expected diaries (85.7%) each week. Submission did not differ substantially across gender, race/ethnicity and baseline sexually transmitted infection status. A sufficient volume and range of sexual behaviors were captured, with reporting trends in different legal and illegal behaviors showing small variation over time. Participants found the methodology to be acceptable, enjoyed and felt comfortable participating in the study. Achieving the correct medium of data collection can drastically improve, or degrade, the timeliness and quality of an individual's self-reported sexual risk behavior, which in turn, is a key factor in the success of intervention or education programs relying on this information. Our findings demonstrate that completion of electronic diaries via cellular phone is feasible way to describe STI/HIV risk among clinically recruited adult men and women.

Feasibility of the Enhancing Participation In the Community by improving Wheelchair Skills (EPIC Wheels) program: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Many older adults rely on a manual wheelchair for mobility but typically receive little, if any, training on how to use their wheelchair effectively and independently. Standardized skill training is an effective intervention, but limited access to clinician trainers is a substantive barrier. Enhancing Participation in the Community by Improving Wheelchair Skills (EPIC Wheels) is a 1-month monitored home training program for improving mobility skills in older novice manual wheelchair users, integrating principles from andragogy and social cognitive theory. The purpose of this study is to determine whether feasibility indicators and primary clinical outcome measures of the EPIC Wheels program are sufficiently robust to justify conducting a subsequent multi-site randomized controlled trial. Methods A 2 × 2 factorial randomized controlled trial at two sites will compare improvement in wheelchair mobility skills between an EPIC Wheels treatment group and a computer-game control group, with additional wheelchair use introduced as a second factor. A total of 40 community-dwelling manual wheelchair users at least 55 years old and living in two Canadian metropolitan cities (n = 20 × 2) will be recruited. Feasibility indicators related to study process, resources, management, and treatment issues will be collected during data collection and at the end of the study period, and evaluated against proposed criteria. Clinical outcome measures will be collected at baseline (pre-randomization) and post-intervention. The primary clinical outcome measure is wheelchair skill capacity, as determined by the Wheelchair Skills Test, version 4.1. Secondary clinical outcome measures include wheelchair skill safety, satisfaction with performance, wheelchair confidence, life-space mobility, divided-attention, and health-related quality of life. Discussion The EPIC Wheels training program offers several innovative features. The convenient, portable, economical, and adaptable tablet-based, home program model for wheelchair skills training has great potential for clinical uptake and opportunity for future enhancements. Theory-driven design can foster learning and adherence for older adults. Establishing the feasibility of the study protocol and estimating effect size for the primary clinical outcome measure will be used to develop a multi-site randomized controlled trial to test the guiding hypotheses. Trial registration Clinical Trials NCT01740635. PMID:24156396

A process for Decision-making after Pilot and feasibility Trials (ADePT): development following a feasibility study of a complex intervention for pelvic organ prolapse

PubMed Central

2013-01-01

Background Current Medical Research Council (MRC) guidance on complex interventions advocates pilot trials and feasibility studies as part of a phased approach to the development, testing, and evaluation of healthcare interventions. In this paper we discuss the results of a recent feasibility study and pilot trial for a randomized controlled trial (RCT) of pelvic floor muscle training for prolapse (ClinicalTrials.gov: NCT01136889). The ways in which researchers decide to respond to the results of feasibility work may have significant repercussions for both the nature and degree of tension between internal and external validity in a definitive trial. Methods We used methodological issues to classify and analyze the problems that arose in the feasibility study. Four centers participated with the aim of randomizing 50 women. Women were eligible if they had prolapse of any type, of stage I to IV, and had a pessary successfully fitted. Postal questionnaires were administered at baseline, 6 months, and 7 months post-randomization. After identifying problems arising within the pilot study we then sought to locate potential solutions that might minimize the trade-off between a subsequent explanatory versus pragmatic trial. Results The feasibility study pointed to significant potential problems in relation to participant recruitment, features of the intervention, acceptability of the intervention to participants, and outcome measurement. Finding minimal evidence to support our decision-making regarding the transition from feasibility work to a trial, we developed a systematic process (A process for Decision-making after Pilot and feasibility Trials (ADePT)) which we subsequently used as a guide. The process sought to: 1) encourage the systematic identification and appraisal of problems and potential solutions; 2) improve the transparency of decision-making processes; and 3) reveal the tensions that exist between pragmatic and explanatory choices. Conclusions We have developed a process that may aid researchers in their attempt to identify the most appropriate solutions to problems identified within future pilot and feasibility RCTs. The process includes three key steps: a decision about the type of problem, the identification of all solutions (whether addressed within the intervention, trial design or clinical context), and a systematic appraisal of these solutions. PMID:24160371

Validation of a Plasma-Based Comprehensive Cancer Genotyping Assay Utilizing Orthogonal Tissue- and Plasma-Based Methodologies.

PubMed

Odegaard, Justin I; Vincent, John J; Mortimer, Stefanie; Vowles, James V; Ulrich, Bryan C; Banks, Kimberly C; Fairclough, Stephen R; Zill, Oliver A; Sikora, Marcin; Mokhtari, Reza; Abdueva, Diana; Nagy, Rebecca J; Lee, Christine E; Kiedrowski, Lesli A; Paweletz, Cloud P; Eltoukhy, Helmy; Lanman, Richard B; Chudova, Darya I; Talasaz, AmirAli

2018-04-24

Purpose: To analytically and clinically validate a circulating cell-free tumor DNA sequencing test for comprehensive tumor genotyping and demonstrate its clinical feasibility. Experimental Design: Analytic validation was conducted according to established principles and guidelines. Blood-to-blood clinical validation comprised blinded external comparison with clinical droplet digital PCR across 222 consecutive biomarker-positive clinical samples. Blood-to-tissue clinical validation comprised comparison of digital sequencing calls to those documented in the medical record of 543 consecutive lung cancer patients. Clinical experience was reported from 10,593 consecutive clinical samples. Results: Digital sequencing technology enabled variant detection down to 0.02% to 0.04% allelic fraction/2.12 copies with ≤0.3%/2.24-2.76 copies 95% limits of detection while maintaining high specificity [prevalence-adjusted positive predictive values (PPV) >98%]. Clinical validation using orthogonal plasma- and tissue-based clinical genotyping across >750 patients demonstrated high accuracy and specificity [positive percent agreement (PPAs) and negative percent agreement (NPAs) >99% and PPVs 92%-100%]. Clinical use in 10,593 advanced adult solid tumor patients demonstrated high feasibility (>99.6% technical success rate) and clinical sensitivity (85.9%), with high potential actionability (16.7% with FDA-approved on-label treatment options; 72.0% with treatment or trial recommendations), particularly in non-small cell lung cancer, where 34.5% of patient samples comprised a directly targetable standard-of-care biomarker. Conclusions: High concordance with orthogonal clinical plasma- and tissue-based genotyping methods supports the clinical accuracy of digital sequencing across all four types of targetable genomic alterations. Digital sequencing's clinical applicability is further supported by high rates of technical success and biomarker target discovery. Clin Cancer Res; 1-11. ©2018 AACR. ©2018 American Association for Cancer Research.

A review of empirical research related to the use of small quantitative samples in clinical outcome scale development.

PubMed

Houts, Carrie R; Edwards, Michael C; Wirth, R J; Deal, Linda S

2016-11-01

There has been a notable increase in the advocacy of using small-sample designs as an initial quantitative assessment of item and scale performance during the scale development process. This is particularly true in the development of clinical outcome assessments (COAs), where Rasch analysis has been advanced as an appropriate statistical tool for evaluating the developing COAs using a small sample. We review the benefits such methods are purported to offer from both a practical and statistical standpoint and detail several problematic areas, including both practical and statistical theory concerns, with respect to the use of quantitative methods, including Rasch-consistent methods, with small samples. The feasibility of obtaining accurate information and the potential negative impacts of misusing large-sample statistical methods with small samples during COA development are discussed.

Computerised mirror therapy with Augmented Reflection Technology for early stroke rehabilitation: clinical feasibility and integration as an adjunct therapy.

PubMed

Hoermann, Simon; Ferreira Dos Santos, Luara; Morkisch, Nadine; Jettkowski, Katrin; Sillis, Moran; Devan, Hemakumar; Kanagasabai, Parimala S; Schmidt, Henning; Krüger, Jörg; Dohle, Christian; Regenbrecht, Holger; Hale, Leigh; Cutfield, Nicholas J

2017-07-01

New rehabilitation strategies for post-stroke upper limb rehabilitation employing visual stimulation show promising results, however, cost-efficient and clinically feasible ways to provide these interventions are still lacking. An integral step is to translate recent technological advances, such as in virtual and augmented reality, into therapeutic practice to improve outcomes for patients. This requires research on the adaptation of the technology for clinical use as well as on the appropriate guidelines and protocols for sustainable integration into therapeutic routines. Here, we present and evaluate a novel and affordable augmented reality system (Augmented Reflection Technology, ART) in combination with a validated mirror therapy protocol for upper limb rehabilitation after stroke. We evaluated components of the therapeutic intervention, from the patients' and the therapists' points of view in a clinical feasibility study at a rehabilitation centre. We also assessed the integration of ART as an adjunct therapy for the clinical rehabilitation of subacute patients at two different hospitals. The results showed that the combination and application of the Berlin Protocol for Mirror Therapy together with ART was feasible for clinical use. This combination was integrated into the therapeutic plan of subacute stroke patients at the two clinical locations where the second part of this research was conducted. Our findings pave the way for using technology to provide mirror therapy in clinical settings and show potential for the more effective use of inpatient time and enhanced recoveries for patients. Implications for Rehabilitation Computerised Mirror Therapy is feasible for clinical use Augmented Reflection Technology can be integrated as an adjunctive therapeutic intervention for subacute stroke patients in an inpatient setting Virtual Rehabilitation devices such as Augmented Reflection Technology have considerable potential to enhance stroke rehabilitation.

Implementing the NICE osteoarthritis guidelines: a mixed methods study and cluster randomised trial of a model osteoarthritis consultation in primary care--the Management of OsteoArthritis In Consultations (MOSAICS) study protocol.

PubMed

Dziedzic, Krysia S; Healey, Emma L; Porcheret, Mark; Ong, Bie Nio; Main, Chris J; Jordan, Kelvin P; Lewis, Martyn; Edwards, John J; Jinks, Clare; Morden, Andrew; McHugh, Gretl A; Ryan, Sarah; Finney, Andrew; Jowett, Sue; Oppong, Raymond; Afolabi, Ebenezer; Pushpa-Rajah, Angela; Handy, June; Clarkson, Kris; Mason, Elizabeth; Whitehurst, Tracy; Hughes, Rhian W; Croft, Peter R; Hay, Elaine M

2014-08-27

There is as yet no evidence on the feasibility of implementing recommendations from the National Institute of Health and Care Excellence (NICE) osteoarthritis (OA) guidelines in primary care, or of the effect these recommendations have on the condition. The primary aim of this study is to determine the clinical and cost effectiveness of a model OA consultation (MOAC), implementing the core recommendations from the NICE OA guidelines in primary care. Secondary aims are to investigate the impact, feasibility and acceptability of the MOAC intervention; to develop and evaluate a training package for management of OA by general practitioners (GPs) and practice nurses; test the feasibility of deriving 'quality markers' of OA management using a new consultation template and medical record review; and describe the uptake of core NICE OA recommendations in participants aged 45 years and over with joint pain. A mixed methods study with a nested cluster randomised controlled trial. This study was developed according to a defined theoretical framework (the Whole System Informing Self-management Engagement). An overarching model (the Normalisation Process Theory) will be employed to undertake a comprehensive 'whole-system' evaluation of the processes and outcomes of implementing the MOAC intervention. The primary outcome is general physical health (Short Form-12 Physical component score [PCS]) (Ware 1996). The impact, acceptability and feasibility of the MOAC intervention at practice level will be assessed by comparing intervention and control practices using a Quality Indicators template and medical record review. Impact and acceptability of the intervention for patients will be assessed via self-completed outcome measures and semi-structured interviews. The impact, acceptability and feasibility of the MOAC intervention and training for GPs and practice nurses will be evaluated using a variety of methods including questionnaires, semi-structured interviews, and observations. The main output from the study will be to determine whether the MOAC intervention is clinically and cost effective. Additional outputs will be the development of the MOAC for patients consulting with joint pain in primary care, training and educational materials, and resources for patients and professionals regarding supported self-management and uptake of NICE guidance. ISRCTN number: ISRCTN06984617.

76 FR 70152 - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

...] Pilot Program for Early Feasibility Study Investigational Device Exemption Applications AGENCY: Food and... feasibility study investigational device exemption (IDE) applications. The pilot program will conform to the... Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies.'' Under the pilot...

Point-of-care washing of allogeneic red blood cells for the prevention of transfusion-related respiratory complications (WAR-PRC): a protocol for a multicenter randomised clinical trial in patients undergoing cardiac surgery

PubMed Central

Warner, Matthew A; Welsby, Ian J; Norris, Phillip J; Silliman, Christopher C; Armour, Sarah; Wittwer, Erica D; Santrach, Paula J; Meade, Laurie A; Liedl, Lavonne M; Nieuwenkamp, Chelsea M; Douthit, Brian; van Buskirk, Camille M; Schulte, Phillip J; Kor, Daryl J

2017-01-01

Introduction The transfusion-related respiratory complications, transfusion-related acute lung injury (TRALI) and transfusion-associated circulatory overload (TACO), are leading causes of transfusion-related morbidity and mortality. At present, there are no effective preventive strategies with red blood cell (RBC) transfusion. Although mechanisms remain incompletely defined, soluble biological response modifiers (BRMs) within the RBC storage solution may play an important role. Point-of-care (POC) washing of allogeneic RBCs may remove these BRMs, thereby mitigating their impact on post-transfusion respiratory complications. Methods and analysis This is a multicenter randomised clinical trial of standard allogeneic versus washed allogeneic RBC transfusion for adult patients undergoing cardiac surgery testing the hypothesis that POC RBC washing is feasible, safe, and efficacious and will reduce recipient immune and physiologic responses associated with transfusion-related respiratory complications. Relevant clinical outcomes will also be assessed. This investigation will enrol 170 patients at two hospitals in the USA. Simon’s two-stage design will be used to assess the feasibility of POC RBC washing. The primary safety outcomes will be assessed using Wilcoxon Rank-Sum tests for continuous variables and Pearson chi-square test for categorical variables. Standard mixed modelling practices will be employed to test for changes in biomarkers of lung injury following transfusion. Linear regression will assess relationships between randomised group and post-transfusion physiologic measures. Ethics and dissemination Safety oversight will be conducted under the direction of an independent Data and Safety Monitoring Board (DSMB). Approval of the protocol was obtained by the DSMB as well as the institutional review boards at each institution prior to enrolling the first study participant. This study aims to provide important information regarding the feasibility of POC washing of allogeneic RBCs and its potential impact on ameliorating post-transfusion respiratory complications. Additionally, it will inform the feasibility and scientific merit of pursuing a more definitive phase II/III clinical trial. Registration ClinicalTrials.gov registration number is NCT02094118 (Pre-results). PMID:28821525

Stepped and Standard Care for Childhood Trauma: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

Salloum, Alison; Small, Brent J.; Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

2017-01-01

Objective: This study explored the feasibility of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) relative to TF-CBT with children (aged 8--12). Method: Children (N = 33) with post-traumatic stress symptoms (PTSS) were randomly assigned (2:1) to SC-TF-CBT or TF-CBT. SC-TF-CBT consisted of Step 1, parent-led therapist-assisted…

Computer-Assisted Cognitive Behavioral Therapy for Child Anxiety: Results of a Randomized Clinical Trial

ERIC Educational Resources Information Center

Khanna, Muniya S.; Kendall, Philip C.

2010-01-01

Objective: This study examined the feasibility, acceptability, and effects of Camp Cope-A-Lot (CCAL), a computer-assisted cognitive behavioral therapy (CBT) for anxiety in youth. Method: Children (49; 33 males) ages 7-13 (M = 10.1 [plus or minus] 1.6; 83.7% Caucasian, 14.2% African American, 2% Hispanic) with a principal anxiety disorder were…

Community Engagement in the CTSA Program: Stakeholder Responses from a National Delphi Process

PubMed Central

Seifer, Sarena D.; Stupak, Matthew; Martinez, Linda Sprague

2014-01-01

Abstract In response to the Institute of Medicine (IOM) Committee's December 2012 public request for stakeholder input on the Clinical and Translational Science Award (CTSA) program, two nonprofit organizations, the Center for Community Health Education Research and Service, Inc. (CCHERS) and Community‐Campus Partnerships for Health (CCPH), solicited feedback from CTSA stakeholders using the Delphi method. Academic and community stakeholders were invited to participate in the Delphi, which is an exploratory method used for group consensus building. Six questions posed by the IOM Committee to an invited panel on community engagement were electronically sent to stakeholders. In Round 1 stakeholder responses were coded thematically and then tallied. Round 2 asked stakeholders to state their level of agreement with each of the themes using a Likert scale. Finally, in Round 3 the group was asked to rank the Round 2 based on potential impact for the CTSA program and implementation feasibility. The benefits of community engagement in clinical and translational research as well as the need to integrate community engagement across all components of the CTSA program were common themes. Respondents expressed skepticism as to the feasibility of strengthening CTSA community engagement. PMID:24841362

Community engagement in the CTSA program: stakeholder responses from a national Delphi process.

PubMed

Freeman, Elmer; Seifer, Sarena D; Stupak, Matthew; Martinez, Linda Sprague

2014-06-01

In response to the Institute of Medicine (IOM) Committee's December 2012 public request for stakeholder input on the Clinical and Translational Science Award (CTSA) program, two nonprofit organizations, the Center for Community Health Education Research and Service, Inc. (CCHERS) and Community-Campus Partnerships for Health (CCPH), solicited feedback from CTSA stakeholders using the Delphi method. Academic and community stakeholders were invited to participate in the Delphi, which is an exploratory method used for group consensus building. Six questions posed by the IOM Committee to an invited panel on community engagement were electronically sent to stakeholders. In Round 1 stakeholder responses were coded thematically and then tallied. Round 2 asked stakeholders to state their level of agreement with each of the themes using a Likert scale. Finally, in Round 3 the group was asked to rank the Round 2 based on potential impact for the CTSA program and implementation feasibility. The benefits of community engagement in clinical and translational research as well as the need to integrate community engagement across all components of the CTSA program were common themes. Respondents expressed skepticism as to the feasibility of strengthening CTSA community engagement. © 2014 Wiley Periodicals, Inc.

Feasibility and acceptability of the DSM-5 Field Trial procedures in the Johns Hopkins Community Psychiatry Programs.

PubMed

Clarke, Diana E; Wilcox, Holly C; Miller, Leslie; Cullen, Bernadette; Gerring, Joan; Greiner, Lisa H; Newcomer, Alison; McKitty, Mellisha V; Regier, Darrel A; Narrow, William E

2014-06-01

The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) contains criteria for psychiatric diagnoses that reflect advances in the science and conceptualization of mental disorders and address the needs of clinicians. DSM-5 also recommends research on dimensional measures of cross-cutting symptoms and diagnostic severity, which are expected to better capture patients' experiences with mental disorders. Prior to its May 2013 release, the American Psychiatric Association (APA) conducted field trials to examine the feasibility, clinical utility, reliability, and where possible, the validity of proposed DSM-5 diagnostic criteria and dimensional measures. The methods and measures proposed for the DSM-5 field trials were pilot tested in adult and child/adolescent clinical samples, with the goal to identify and correct design and procedural problems with the proposed methods before resources were expended for the larger DSM-5 Field Trials. Results allowed for the refinement of the protocols, procedures, and measures, which facilitated recruitment, implementation, and completion of the DSM-5 Field Trials. These results highlight the benefits of pilot studies in planning large multisite studies. Copyright © 2013, American Psychiatric Association. All rights reserved.

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

PubMed

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

2013-03-01

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

The Acceptability and Feasibility of Implementing a Bio-Behavioral Enhanced Surveillance Tool for Sexually Transmitted Infections in England: Mixed-Methods Study.

PubMed

Wayal, Sonali; Reid, David; Blomquist, Paula B; Weatherburn, Peter; Mercer, Catherine H; Hughes, Gwenda

2018-05-04

Sexually transmitted infection (STI) surveillance is vital for tracking the scale and pattern of epidemics; however, it often lacks data on the underlying drivers of STIs. This study aimed to assess the acceptability and feasibility of implementing a bio-behavioral enhanced surveillance tool, comprising a self-administered Web-based survey among sexual health clinic attendees, as well as linking this to their electronic health records (EHR) held in England's national STI surveillance system. Staff from 19 purposively selected sexual health clinics across England and men who have sex with men and black Caribbeans, because of high STI burden among these groups, were interviewed to assess the acceptability of the proposed bio-behavioral enhanced surveillance tool. Subsequently, sexual health clinic staff invited all attendees to complete a Web-based survey on drivers of STI risk using a study tablet or participants' own digital device. They recorded the number of attendees invited and participants' clinic numbers, which were used to link survey data to the EHR. Participants' online consent was obtained, separately for survey participation and linkage. In postimplementation phase, sexual health clinic staff were reinterviewed to assess the feasibility of implementing the bio-behavioral enhanced surveillance tool. Acceptability and feasibility of implementing the bio-behavioral enhanced surveillance tool were assessed by analyzing these qualitative and quantitative data. Prior to implementation of the bio-behavioral enhanced surveillance tool, sexual health clinic staff and attendees emphasized the importance of free internet/Wi-Fi access, confidentiality, and anonymity for increasing the acceptability of the bio-behavioral enhanced surveillance tool among attendees. Implementation of the bio-behavioral enhanced surveillance tool across sexual health clinics varied considerably and was influenced by sexual health clinics' culture of prioritization of research and innovation and availability of resources for implementing the surveys. Of the 7367 attendees invited, 85.28% (6283) agreed to participate. Of these, 72.97% (4585/6283) consented to participate in the survey, and 70.62% (4437/6283) were eligible and completed it. Of these, 91.19% (4046/4437) consented to EHR linkage, which did not differ by age or gender but was higher among gay/bisexual men than heterosexual men (95.50%, 722/756 vs 88.31%, 1073/1215; P<.003) and lower among black Caribbeans than white participants (87.25%, 568/651 vs 93.89%, 2181/2323; P<.002). Linkage was achieved for 88.88% (3596/4046) of consenting participants. Implementing a bio-behavioral enhanced surveillance tool in sexual health clinics was feasible and acceptable to staff and groups at STI risk; however, ensuring participants' confidentiality and anonymity and availability of resources is vital. Bio-behavioral enhanced surveillance tools could enable timely collection of detailed behavioral data for effective commissioning of sexual health services. ©Sonali Wayal, David Reid, Paula B Blomquist, Peter Weatherburn, Catherine H Mercer, Gwenda Hughes. Originally published in JMIR Public Health and Surveillance (http://publichealth.jmir.org), 04.05.2018.

A Feasibility Study of a Web Based Performance Improvement System for Substance Abuse Treatment Providers

PubMed Central

Forman, Robert; Crits-Christoph, Paul; Kaynak, Övgü; Worley, Matt; Hantula, Donald A.; Kulaga, Agatha; Rotrosen, John; Chu, Melissa; Gallop, Robert; Potter, Jennifer; Muchowski, Patrice; Brower, Kirk; Strobbe, Stephen; Magruder, Kathy; Chellis, A’Delle H.; Clodfelter, Tad; Cawley, Margaret

2007-01-01

We report here on the feasibility of implementing a semi-automated performance improvement system - Patient Feedback (PF) - that enables real-time monitoring of patient ratings of therapeutic alliance, treatment satisfaction, and drug/alcohol use in outpatient substance abuse treatment clinics. The study was conducted in 6 clinics within the National Institute on Drug Abuse Clinical Trials Network. It involved a total of thirty-nine clinicians and 6 clinic supervisors. Throughout the course of the study (4 week training period, 4 week baseline, 12 week intervention, 4 week post-intervention assessment, 1 year sustainability phase) there was an overall collection rate of 75.5% of the clinic patient census. In general, the clinicians in these clinics had very positive treatment satisfaction and alliance ratings throughout the study. However, one clinic had worse drug use scores at baseline than other participating clinics, and showed a decrease in self-reported drug use at post-intervention. Although the implementation of the PF system proved to be feasible in actual clinical settings, further modifications of the PF system are needed to enhance any potential clinical usefulness. PMID:17499954

Analysis of Plane-Parallel Electron Beam Propagation in Different Media by Numerical Simulation Methods

NASA Astrophysics Data System (ADS)

Miloichikova, I. A.; Bespalov, V. I.; Krasnykh, A. A.; Stuchebrov, S. G.; Cherepennikov, Yu. M.; Dusaev, R. R.

2018-04-01

Simulation by the Monte Carlo method is widely used to calculate the character of ionizing radiation interaction with substance. A wide variety of programs based on the given method allows users to choose the most suitable package for solving computational problems. In turn, it is important to know exactly restrictions of numerical systems to avoid gross errors. Results of estimation of the feasibility of application of the program PCLab (Computer Laboratory, version 9.9) for numerical simulation of the electron energy distribution absorbed in beryllium, aluminum, gold, and water for industrial, research, and clinical beams are presented. The data obtained using programs ITS and Geant4 being the most popular software packages for solving the given problems and the program PCLab are presented in the graphic form. A comparison and an analysis of the results obtained demonstrate the feasibility of application of the program PCLab for simulation of the absorbed energy distribution and dose of electrons in various materials for energies in the range 1-20 MeV.

Protocol of a Pilot Study of Technology-Enabled Coproduction in Pediatric Chronic Illness Care

PubMed Central

Thakkar, Sunny Narendra; Burns, Lisa; Chini, Barbara; Dykes, Dana MH; McPhail, Gary L; Moore, Erin; Saeed, Shehzad Ahmed; Eslick, Ian; Margolis, Peter A

2017-01-01

Background Pediatric chronic illness care models are traditionally organized around acute episodes of care and may not meet the needs of patients and their families. Interventions that extend the patient-clinician interaction beyond the health care visit, allow for asynchronous and bidirectional feedback loops that span visits and daily life, and facilitate seamless sharing of information are needed to support a care delivery system that is more collaborative, continuous, and data-driven. Orchestra is a mobile health technology platform and intervention designed to transform the management of chronic diseases by optimizing patient-clinician coproduction of care. Objective The aim of this study is to assess the feasibility, acceptability, and preliminary impact of the Orchestra technology and intervention in the context of pediatric chronic illness care. Methods This study will be conducted in the cystic fibrosis and inflammatory bowel disease clinics at Cincinnati Children’s Hospital Medical Center. We will enroll interested patients and their caregivers to work with clinicians to use the Orchestra technology platform and care model over a 6-month period. In parallel, we will use quality improvement methods to improve processes for integrating Orchestra into clinic workflows and patient/family lifestyles. We will use surveys, interviews, technology use data, and measures of clinical outcomes to assess the feasibility, acceptability, and preliminary impact of Orchestra. Outcome measures will include assessments of: (1) enrollment and dropout rates; (2) duration of engagement/sustained use; (3) symptom and patient-reported outcome tracker completion rates; (4) perceived impact on treatment plan, communication with the clinical team, visit preparation, and overall care; (5) changes in disease self-efficacy and engagement in care; and (6) clinical outcomes and health care utilization. Results Participant recruitment began in mid-2015, with results expected in 2017. Conclusions Chronic disease management needs a dramatic transformation to support more collaborative, effective, and patient-centered care. This study is unique in that it is testing not only the impact of technology, but also the necessary processes that facilitate patient and clinician collaboration. This pilot study is designed to examine how technology-enabled coproduction can be implemented in real-life clinical contexts. Once the Orchestra technology and intervention are optimized to ensure feasibility and acceptability, future studies can test the effectiveness of this approach to improve patient outcomes and health care value. PMID:28455274

A mixed methods study to assess the feasibility of a randomised controlled trial of invasive urodynamic testing versus clinical assessment and non-invasive tests prior to surgery for stress urinary incontinence in women: the INVESTIGATE-I study.

PubMed

Hilton, Paul; Armstrong, Natalie; Brennand, Catherine; Howel, Denise; Shen, Jing; Bryant, Andrew; Tincello, Douglas G; Lucas, Malcolm G; Buckley, Brian S; Chapple, Christopher R; Homer, Tara; Vale, Luke; McColl, Elaine

2015-09-08

The position of invasive urodynamic testing (IUT) in diagnostic pathways for urinary incontinence is unclear, and systematic reviews have called for further trials evaluating clinical utility. The objective of this study was to inform the decision whether to proceed to a definitive randomised trial of IUT compared to clinical assessment with non-invasive tests, prior to surgery in women with stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (MUI). A mixed methods study comprising a pragmatic multicentre randomised pilot trial, a qualitative face-to face interview study with patients eligible for the trial, an exploratory economic evaluation including value of information study, a survey of clinicians' views about IUT, and qualitative telephone interviews with purposively sampled survey respondents. Only the first and second of these elements are reported here. Trial participants were randomised to either clinical assessment with non-invasive tests (control arm) or clinical assessment with non-invasive tests plus IUT (intervention arm). The main outcome measures of these feasibility studies were confirmation that units can identify and recruit eligible women, acceptability of investigation strategies and data collection tools, and acquisition of outcome data to determine the sample size for a definitive trial. The primary outcome proposed for a definitive trial was ICIQ-FLUTS (total score) 6 months after surgery or the start of nonsurgical treatment. Of 284 eligible women, 222 (78%) were recruited, 165/219 (75%) returned questionnaires at baseline, and 125/200 returned them (63%) at follow-up. Most women underwent surgery; management plans were changed in 19 (19%) participants following IUT. Participants interviewed were positive about the trial and the associated documentation. All elements of a definitive trial were rehearsed. Such a trial would require between 232 and 922 participants, depending on the target difference in the primary outcome. We identified possible modifications to our protocol for application in a definitive trial including clarity over inclusion/exclusions, screening processes, reduction in secondary outcomes, and modification to patient questionnaire booklets and bladder diaries. A definitive trial of IUT versus clinical assessment prior to surgery for SUI or stress predominant MUI is feasible and remains relevant. Current Controlled Trials: ISRCTN 71327395, registered 7 June 2010.

Cutaneous respirometry by dynamic measurement of mitochondrial oxygen tension for monitoring mitochondrial function in vivo.

PubMed

Harms, Floor A; Voorbeijtel, Wilhelmina J; Bodmer, Sander I A; Raat, Nicolaas J H; Mik, Egbert G

2013-09-01

Progress in diagnosis and treatment of mitochondrial dysfunction in chronic and acute disease could greatly benefit from techniques for monitoring of mitochondrial function in vivo. In this study we demonstrate the feasibility of in vivo respirometry in skin. Mitochondrial oxygen measurements by means of oxygen-dependent delayed fluorescence of protoporphyrin IX are shown to provide a robust basis for measurement of local oxygen disappearance rate (ODR). The fundamental principles behind the technology are described, together with an analysis method for retrievel of respirometry data. The feasibility and reproducibility of this clinically useful approach are demonstrated in a series of rats. Copyright © 2012 Elsevier B.V. All rights reserved.

Assessing commercial feasibility: a practical and ethical prerequisite for human clinical testing.

PubMed

Kirk, Dwayne D; Robert, Jason Scott

2005-01-01

This article proposes that an assessment of commercial feasibility should be integrated as a prerequisite for human clinical testing to improve the quality and relevance of materials being investigated, as an ethical aspect for human subject protection, and as a means of improving accountability where clinical development is funded on promises of successful translational research. A commercial feasibility analysis is not currently required to justify human clinical testing, but is assumed to have been conducted by industry participants, and use of public funds for clinical trials should be defensible in the same manner. Plant-made vaccines (PMVs) are offered in this discussion as a model for evaluating the relevance of commercial feasibility before human clinical testing. PMVs have been proposed as a potential solution for global health, based on a vision of immunizing the world against many infectious diseases. Such a vision depends on translating current knowledge in plant science and immunology into a potent vaccine that can be readily manufactured and distributed to those in need. But new biologics such as PMVs may fail to be manufactured due to financial or logistical reasons--particularly for orphan diseases without sufficient revenue incentive for industry investment--regardless of the effectiveness which might be demonstrated in human clinical testing. Moreover, all potential instruments of global health depend on translational agents well beyond the lab in order to reach those in need. A model compromising five criteria for commercial feasibility is suggested for inclusion by regulators and ethics review boards as part of the review process prior to approval of human clinical testing. Use of this model may help to facilitate safe and appropriate translational research and bring more immediate benefits to those in need.

Feasibility, appropriateness, meaningfulness and effectiveness of patient participation at bedside shift reporting: mixed-method research protocol.

PubMed

Malfait, Simon; Eeckloo, Kristof; Lust, Elisa; Van Biesen, Wim; Van Hecke, Ann

2017-02-01

To evaluate the feasibility, appropriateness, meaningfulness and effectiveness of bedside shift reporting in a minimum of five interventions and five control wards. Hospitals continually improve their quality of care. Next to improvements in clinical performance, more patient participation is stimulated through different methods. Methods to enhance patient participation such as bedside shift reporting lack rigorously performed research to determine their feasibility, appropriateness, meaningfulness and effectiveness. Small-scale research and a previous pilot study indicate that bedside shift reporting improves patient participation, nurse-nurse communication and nurse-patient communication. The development, implementation and evaluation of bedside shift report are based on the Medical Research Council framework for complex interventions in health care. A matched, controlled, mixed-method, longitudinal study design will be used. The Feasibility-Appropriateness-Meaningfulness-Effectiveness framework will be applied for the quantitative and qualitative evaluation of bedside shift report. A tailored intervention and implementation process for bedside shift report will be developed using diagnostic interviews, co-design and acceptability testing. The intervention will be evaluated before implementation and three times after implementation. Individual and focus group interviews will be performed. Questionnaires, observations and analysis of the medical records and administrative databases will be completed. This study was funded in October 2015. Research Ethics Committee approval was granted in March 2016. There is a pressing need for rigorous research into the effects of interventions for improving patient participation. This study addresses the significance of bedside shift report as an intervention to improve quality of care, communication and patient participation within a large-scale, matched, controlled research design. © 2016 John Wiley & Sons Ltd.

Feasibility of a Sexual Health Clinic Within Cancer Care: A Pilot Study Using Qualitative Methods.

PubMed

Tracy, Myrna; McDivitt, Karmen; Ryan, Maureen; Tomlinson, Jamie; Brotto, Lori A

2016-01-01

As cancer survival rates increase, so does the imperative for a satisfying quality of life, including a fulfilling sexual life. The feasibility and effectiveness of a newly formed Sexual Health Clinic were determined using a nurse-led format, which provided support to survivors in a cancer care setting. Twenty-one cancer survivors received assessment, education, and tailored sexual health support by an oncology nurse with specialized skills in sexual health. Two months later, semistructured interviews focused on patients' personal experiences. Questionnaires were also administered to healthcare providers involved in providing the follow-up care. Participants presented with sexual concerns that were psychological, physical, and/or relational. Scores on validated measures of sexual functioning were in the range comparable to those with a sexual dysfunction. Participants were open to being asked about sexual health and wanted professionals available who were skilled in dealing with sexual health services. Most participants experienced an improvement in their well-being and/or sexual life following participation. Some noted more confidence when speaking with their partner about sexual concerns. Our pilot Sexual Health Clinic was feasible, and evidence for its effectiveness was based on qualitative feedback. Participants and providers identified a strong need for the inclusion of sexual health services in cancer care. Oncology nurses are in a key position to initiate discussions surrounding sexual health issues related to cancer treatment. Self-awareness, sensitivity, and a nonjudgmental approach are required to address this dimension of holistic cancer care.

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

PubMed Central

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

2016-01-01

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

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.

Patient-reported outcomes in neurofibromatosis and schwannomatosis clinical trials.

PubMed

Wolters, Pamela L; Martin, Staci; Merker, Vanessa L; Gardner, Kathy L; Hingtgen, Cynthia M; Tonsgard, James H; Schorry, Elizabeth K; Baldwin, Andrea

2013-11-19

Neurofibromatosis (NF) is a genetic disease with multiple clinical manifestations that can significantly impact quality of life (QOL). Clinical trials should include patient-reported outcomes (PROs) as endpoints to assess treatment effects on various aspects of QOL, but there is no consensus on the selection and use of such measures in NF. This article describes the PRO Working Group of the Response Evaluation in Neurofibromatosis and Schwannomatosis (REiNS) Collaboration, its main goals, methods for identifying appropriate PRO measures for NF clinical trials, and recommendations for assessing pain intensity. The REiNS PRO group selected core endpoint domains important to assess in NF. The members developed criteria to rate PRO measures, including patient characteristics, psychometric properties, and feasibility, and utilized a systematic process to evaluate PROs for NF clinical trials. Within the subdomain of pain intensity, the group reviewed the Numerical Rating Scale-11 (NRS-11), the Visual Analogue Scale, and the Faces Pain Scale-Revised using this process. Based on the review criteria, each of these pain intensity scales is brief, reliable, valid, and widely used. However, the NRS-11 was given the highest rating for use in NF clinical trials due to recommendations from pain experts and other consensus groups, its extensive use in research, strong psychometric data including sensitivity to change, and excellent feasibility in ages ≥ 8 years. The systematic review criteria and process are effective for identifying appropriate PRO measures and provide information utilized by the REiNS Collaboration to achieve consensus regarding PROs in NF clinical trials.

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.

Vascular Plug Assisted Retrograde Transvenous Obliteration (PARTO) for Gastric Varix Bleeding Patients in the Emergent Clinical Setting

PubMed Central

Yang, Heechul; Lee, Chun Kyon; Kim, Gun Bea

2016-01-01

Purpose To evaluate the technical feasibility and safety of vascular plug assisted retrograde transvenous obliteration (PARTO) for bleeding gastric varix performed in the emergent clinical setting and describe the mid-term clinical results. Materials and Methods From April 2012 to January 2015, emergent PARTO was tried in total 9 patients presented with active gastric varix bleeding. After initial insufficient or failure of endoscopic approach, they underwent PARTO in the emergent clinical setting. Gelatin sponge embolization of both gastrorenal (GR) shunt and gastric varix was performed after retrograde transvenous placement of a vascular plug in GR shunt. Coil assisted RTO (CARTO) was performed in one patient who had challenging GR shunt anatomy for vascular plug placement. Additional embolic materials, such as microcoils and NBCA glue-lipiodol mixture, were required in three patients to enhance complete occlusion of GR shunt or obliteration of competitive collateral vessels. Clinical success was defined as no variceal rebleeding and disappearance of gastric varix. Results All technical and clinical success–i.e., complete GR shunt occlusion and offending gastric varix embolization with immediate bleeding control–was achieved in all 9 patients. There was no procedure-related complication. All cases showed successful clinical outcome during mean follow up of 17 months (12–32 months), evidenced by imaging studies, endoscopy and clinical data. In 4 patients, mild worsening of esophageal varices or transient ascites was noted as portal hypertensive related change. Conclusion Emergent PARTO is technically feasible and safe, with acceptable mid-term clinical results, in treating active gastric varix bleeding. PMID:27189294

[Onyx embolization for treatment of dural arteriovenous fistula: comparison of long- distance versus routine injection method].

PubMed

He, Xiao-Yan; Zhang, Guo-Zhong; Li, Ming-Zhou; Wang, Gang; Liu, Dan; Qi, Song-Tao; Li, Wei-Guang; Feng, Wen-Feng

2016-03-01

To compare the efficacy, clinical characteristics, safety, injection time and radiation exposure of Onyx embolization using a long-distance injection method and routine injection method for management of dural arteriovenous fistula (DAVF). The clinical data were retrospectively analyzed in 59 patients with DAVF treated with Onyx embolization using long-distance injection method (28 patients) and routine injection method (31 patients). The efficacy, safety, injection time and radiation exposure during Onyx embolization were compared between the two injections methods. The average radiation dose exposure to the surgeon per procedure was significantly lower in the long-distance injection group than in the routine group. The injection time (P=0.53), injection volume (P=0.78), number of supply arteries (P=0.80), Cognard types (P=0.67), and effect of embolization (P=0.88) were all similar between the two groups. Endovaseular treatment of intracranial DAVF with Onyx embolization using the long-distance injection method is feasible, safe and effective and can reduce the radiation exposure to the surgeon.

Strengthening Health Systems at Facility-Level: Feasibility of Integrating Antiretroviral Therapy into Primary Health Care Services in Lusaka, Zambia

PubMed Central

Topp, Stephanie M.; Chipukuma, Julien M.; Giganti, Mark; Mwango, Linah K.; Chiko, Like M.; Tambatamba-Chapula, Bushimbwa; Wamulume, Chibesa S.; Reid, Stewart

2010-01-01

Introduction HIV care and treatment services are primarily delivered in vertical antiretroviral (ART) clinics in sub-Saharan Africa but there have been concerns over the impact on existing primary health care services. This paper presents results from a feasibility study of a fully integrated model of HIV and non-HIV outpatient services in two urban Lusaka clinics. Methods Integration involved three key modifications: i) amalgamation of space and patient flow; ii) standardization of medical records and iii) introduction of routine provider initiated testing and counseling (PITC). Assessment of feasibility included monitoring rates of HIV case-finding and referral to care, measuring median waiting and consultation times and assessing adherence to clinical care protocols for HIV and non-HIV outpatients. Qualitative data on patient/provider perceptions was also collected. Findings Provider and patient interviews at both sites indicated broad acceptability of the model and highlighted a perceived reduction in stigma associated with integrated HIV services. Over six months in Clinic 1, PITC was provided to 2760 patients; 1485 (53%) accepted testing, 192 (13%) were HIV positive and 80 (42%) enrolled. Median OPD patient-provider contact time increased 55% (6.9 vs. 10.7 minutes; p<0.001) and decreased 1% for ART patients (27.9 vs. 27.7 minutes; p = 0.94). Median waiting times increased by 36 (p<0.001) and 23 minutes (p<0.001) for ART and OPD patients respectively. In Clinic 2, PITC was offered to 1510 patients, with 882 (58%) accepting testing, 208 (24%) HIV positive and 121 (58%) enrolled. Median OPD patient-provider contact time increased 110% (6.1 vs. 12.8 minutes; p<0.001) and decreased for ART patients by 23% (23 vs. 17.7 minutes; p<0.001). Median waiting times increased by 47 (p<0.001) and 34 minutes (p<0.001) for ART and OPD patients, respectively. Conclusions Integrating vertical ART and OPD services is feasible in the low-resource and high HIV-prevalence setting of Lusaka, Zambia. Integration enabled shared use of space and staffing that resulted in increased HIV case finding, a reduction in stigma associated with vertical ART services but resulted in an overall increase in patient waiting times. Further research is urgently required to assess long-term clinical outcomes and cost effectiveness in order to evaluate scalability and generalizability. PMID:20644629

A clinical carepath for obese pregnant women: A pragmatic pilot cluster randomized controlled trial.

PubMed

McDonald, Sarah D; Viaje, Kristen A; Rooney, Rebecca A; Jarde, Alexander; Giglia, Lucia; Maxwell, Cynthia V; Small, David; Kelly, Tracy Pearce; Midwifery, B H Sc; Sabatino, Lisa; Thabane, Lehana

2018-05-17

Obese women are at increased risks for complications during pregnancy, birth and in their infants. Although guidelines have been established for the clinical care of obese pregnant women, management is sometimes suboptimal. Our goal was to determine the feasibility of implementing and testing a clinical carepath for obese pregnant women compared to standard care, in a pilot cluster randomized controlled trial (RCT). A pragmatic pilot cluster RCT was conducted, randomly allocating eight clinics to the carepath or standard care for obese pregnant women. Women were eligible if they had a prepregnancy body mass index of ≥ 30 kg/m 2 and a viable singleton < 21 weeks. The primary outcomes were the feasibility of conducting a full-scale cluster RCT (defined as > 80%: randomization of clinics, use in eligible women, and completeness of follow-up) and of the intervention (defined as > 80%: compliance with each step in the carepath, and recommendation of the carepath by clinicians to a colleague). All eight approached clinics agreed to participate and were randomized. Half of the intervention clinics used the carepath, resulting in < 80% uptake of eligible women. High follow-up (99.5%) was achieved, in 188 of 189 women. The carepath was feasible for numerous guideline-directed recommendations for screening, but less so for counselling topics. When the carepath was used in the majority of women, all clinicians, most of whom were midwives, reported they would recommend it to a colleague. The intervention group had significantly higher overall adherence to the guideline recommendations compared to control (relative risk 1.71, 95% confidence interval 1.57-1.87). In this pragmatic pilot cluster RCT, a guideline-directed clinical carepath improved some aspects of care of obese pregnant women and was recommended by clinicians, particularly midwives. A cluster RCT may not be feasible in a mix of obstetric and midwifery clinics, but may be feasible in midwifery clinics. This pragmatic pilot cluster RCT was registered on clinicaltrials.gov (identifier: NCT02534051 ).

Is It Feasible to Identify Natural Clusters of TSC-Associated Neuropsychiatric Disorders (TAND)?

PubMed

Leclezio, Loren; Gardner-Lubbe, Sugnet; de Vries, Petrus J

2018-04-01

Tuberous sclerosis complex (TSC) is a genetic disorder with multisystem involvement. The lifetime prevalence of TSC-Associated Neuropsychiatric Disorders (TAND) is in the region of 90% in an apparently unique, individual pattern. This "uniqueness" poses significant challenges for diagnosis, psycho-education, and intervention planning. To date, no studies have explored whether there may be natural clusters of TAND. The purpose of this feasibility study was (1) to investigate the practicability of identifying natural TAND clusters, and (2) to identify appropriate multivariate data analysis techniques for larger-scale studies. TAND Checklist data were collected from 56 individuals with a clinical diagnosis of TSC (n = 20 from South Africa; n = 36 from Australia). Using R, the open-source statistical platform, mean squared contingency coefficients were calculated to produce a correlation matrix, and various cluster analyses and exploratory factor analysis were examined. Ward's method rendered six TAND clusters with good face validity and significant convergence with a six-factor exploratory factor analysis solution. The "bottom-up" data-driven strategies identified a "scholastic" cluster of TAND manifestations, an "autism spectrum disorder-like" cluster, a "dysregulated behavior" cluster, a "neuropsychological" cluster, a "hyperactive/impulsive" cluster, and a "mixed/mood" cluster. These feasibility results suggest that a combination of cluster analysis and exploratory factor analysis methods may be able to identify clinically meaningful natural TAND clusters. Findings require replication and expansion in larger dataset, and could include quantification of cluster or factor scores at an individual level. Copyright © 2018 Elsevier Inc. All rights reserved.

Eight-hours adaptive deep brain stimulation in patients with Parkinson disease

PubMed Central

Arlotti, Mattia; Marceglia, Sara; Foffani, Guglielmo; Volkmann, Jens; Lozano, Andres M.; Moro, Elena; Cogiamanian, Filippo; Prenassi, Marco; Bocci, Tommaso; Cortese, Francesca; Rampini, Paolo; Barbieri, Sergio

2018-01-01

Objectives To assess the feasibility and clinical efficacy of local field potentials (LFPs)–based adaptive deep brain stimulation (aDBS) in patients with advanced Parkinson disease (PD) during daily activities in an open-label, nonblinded study. Methods We monitored neurophysiologic and clinical fluctuations during 2 perioperative experimental sessions lasting for up to 8 hours. On the first day, the patient took his/her daily medication, while on the second, he/she additionally underwent subthalamic nucleus aDBS driven by LFPs beta band power. Results The beta band power correlated in both experimental sessions with the patient's clinical state (Pearson correlation coefficient r = 0.506, p < 0.001, and r = 0.477, p < 0.001). aDBS after LFP changes was effective (30% improvement without medication [3-way analysis of variance, interaction day × medication p = 0.036; 30.5 ± 3.4 vs 22.2 ± 3.3, p = 0.003]), safe, and well tolerated in patients performing regular daily activities and taking additional dopaminergic medication. aDBS was able to decrease DBS amplitude during motor “on” states compared to “off” states (paired t test p = 0.046), and this automatic adjustment of STN-DBS prevented dyskinesias. Conclusions The main findings of our study are that aDBS is technically feasible in everyday life and provides a safe, well-tolerated, and effective treatment method for the management of clinical fluctuations. Classification of evidence This study provides Class IV evidence that for patients with advanced PD, aDBS is safe, well tolerated, and effective in controlling PD motor symptoms. PMID:29444973

Accurate and Standardized Coronary Wave Intensity Analysis.

PubMed

Rivolo, Simone; Patterson, Tiffany; Asrress, Kaleab N; Marber, Michael; Redwood, Simon; Smith, Nicolas P; Lee, Jack

2017-05-01

Coronary wave intensity analysis (cWIA) has increasingly been applied in the clinical research setting to distinguish between the proximal and distal mechanical influences on coronary blood flow. Recently, a cWIA-derived clinical index demonstrated prognostic value in predicting functional recovery postmyocardial infarction. Nevertheless, the known operator dependence of the cWIA metrics currently hampers its routine application in clinical practice. Specifically, it was recently demonstrated that the cWIA metrics are highly dependent on the chosen Savitzky-Golay filter parameters used to smooth the acquired traces. Therefore, a novel method to make cWIA standardized and automatic was proposed and evaluated in vivo. The novel approach combines an adaptive Savitzky-Golay filter with high-order central finite differencing after ensemble-averaging the acquired waveforms. Its accuracy was assessed using in vivo human data. The proposed approach was then modified to automatically perform beat wise cWIA. Finally, the feasibility (accuracy and robustness) of the method was evaluated. The automatic cWIA algorithm provided satisfactory accuracy under a wide range of noise scenarios (≤10% and ≤20% error in the estimation of wave areas and peaks, respectively). These results were confirmed when beat-by-beat cWIA was performed. An accurate, standardized, and automated cWIA was developed. Moreover, the feasibility of beat wise cWIA was demonstrated for the first time. The proposed algorithm provides practitioners with a standardized technique that could broaden the application of cWIA in the clinical practice as enabling multicenter trials. Furthermore, the demonstrated potential of beatwise cWIA opens the possibility investigating the coronary physiology in real time.

Real-Time Data Collection Using Text Messaging in a Primary Care Clinic.

PubMed

Rai, Manisha; Moniz, Michelle H; Blaszczak, Julie; Richardson, Caroline R; Chang, Tammy

2017-12-01

The use of text messaging is nearly ubiquitous and represents a promising method of collecting data from diverse populations. The purpose of this study was to assess the feasibility and acceptability of text message surveys in a clinical setting and to describe key lessons to minimize attrition. We obtained a convenience sample of individuals who entered the waiting room of a low-income, primary care clinic. Participants were asked to answer between 17 and 30 survey questions on a variety of health-related topics, including both open- and closed-ended questions. Descriptive statistics were used to characterize the participants and determine the response rates. Bivariate analyses were used to identify predictors of incomplete surveys. Our convenience sample consisted of 461 individuals. Of those who attempted the survey, 80% (370/461) completed it in full. The mean age of respondents was 35.4 years (standard deviation = 12.4). Respondents were predominantly non-Hispanic black (42%) or non-Hispanic white (41%), female (75%), and with at least some college education (70%). Of those who completed the survey, 84% (312/370) reported willingness to do another text message survey. Those with incomplete surveys answered a median of nine questions before stopping. Smartphone users were less likely to leave the survey incomplete compared with non-smartphone users (p = 0.004). Text-message surveys are a feasible and acceptable method to collect real-time data among low-income, clinic-based populations. Offering participants a setting for immediate survey completion, minimizing survey length, simplifying questions, and allowing "free text" responses for all questions may optimize response rates.

3D-2D registration in endovascular image-guided surgery: evaluation of state-of-the-art methods on cerebral angiograms.

PubMed

Mitrović, Uroš; Likar, Boštjan; Pernuš, Franjo; Špiclin, Žiga

2018-02-01

Image guidance for minimally invasive surgery is based on spatial co-registration and fusion of 3D pre-interventional images and treatment plans with the 2D live intra-interventional images. The spatial co-registration or 3D-2D registration is the key enabling technology; however, the performance of state-of-the-art automated methods is rather unclear as they have not been assessed under the same test conditions. Herein we perform a quantitative and comparative evaluation of ten state-of-the-art methods for 3D-2D registration on a public dataset of clinical angiograms. Image database consisted of 3D and 2D angiograms of 25 patients undergoing treatment for cerebral aneurysms or arteriovenous malformations. On each of the datasets, highly accurate "gold-standard" registrations of 3D and 2D images were established based on patient-attached fiducial markers. The database was used to rigorously evaluate ten state-of-the-art 3D-2D registration methods, namely two intensity-, two gradient-, three feature-based and three hybrid methods, both for registration of 3D pre-interventional image to monoplane or biplane 2D images. Intensity-based methods were most accurate in all tests (0.3 mm). One of the hybrid methods was most robust with 98.75% of successful registrations (SR) and capture range of 18 mm for registrations of 3D to biplane 2D angiograms. In general, registration accuracy was similar whether registration of 3D image was performed onto mono- or biplanar 2D images; however, the SR was substantially lower in case of 3D to monoplane 2D registration. Two feature-based and two hybrid methods had clinically feasible execution times in the order of a second. Performance of methods seems to fall below expectations in terms of robustness in case of registration of 3D to monoplane 2D images, while translation into clinical image guidance systems seems readily feasible for methods that perform registration of the 3D pre-interventional image onto biplanar intra-interventional 2D images.

Caries Detection Methods Based on Changes in Optical Properties between Healthy and Carious Tissue

PubMed Central

Karlsson, Lena

2010-01-01

A conservative, noninvasive or minimally invasive approach to clinical management of dental caries requires diagnostic techniques capable of detecting and quantifying lesions at an early stage, when progression can be arrested or reversed. Objective evidence of initiation of the disease can be detected in the form of distinct changes in the optical properties of the affected tooth structure. Caries detection methods based on changes in a specific optical property are collectively referred to as optically based methods. This paper presents a simple overview of the feasibility of three such technologies for quantitative or semiquantitative assessment of caries lesions. Two of the techniques are well-established: quantitative light-induced fluorescence, which is used primarily in caries research, and laser-induced fluorescence, a commercially available method used in clinical dental practice. The third technique, based on near-infrared transillumination of dental enamel is in the developmental stages. PMID:20454579

Prospective study of the feasibility and effectiveness of a second-trimester quadruple test for Down syndrome in Thailand.

PubMed

Kaewsuksai, Peeranan; Jitsurong, Siroj

2017-11-01

To evaluate the feasibility and effectiveness of a quadruple test for Down syndrome in the second trimester of pregnancy in clinical settings in Thailand. From October 2015 to September 2016, a prospective study was undertaken in 19 hospitals in Songkhla province, Thailand. Women with a singleton pregnancy of 14-18 weeks were enrolled and underwent the quadruple test. The risk cutoff value was set at 1:250. All women with a positive test (risk ≥1:250) were offered amniocentesis. Women were followed up until delivery. Among 2375 women, 206 (8.7%) had a positive quadruple test; 98 (47.6%) of these women voluntarily underwent amniocentesis. Overall, seven pregnancies were complicated with chromosomal abnormalities (2.9 cases in 1000), including four cases of Down syndrome (1.7 in 1000) and three of other abnormalities. The detection, false-positive, and accuracy rates of the quadruple test for Down syndrome were 75.0%, 8.6%, and 91.4%, respectively. The quadruple test was found to be a feasible and efficient method for screening for Down syndrome in the second trimester of pregnancy in a Thai clinical setting. The test should be performed for pregnant women before an invasive test for Down syndrome. © 2017 International Federation of Gynecology and Obstetrics.

Mobile phone text messaging to improve knowledge and practice of diabetic foot care in a developing country: Feasibility and outcomes.

PubMed

Hassan, Zeinab M

2017-06-01

To test the feasibility and effectiveness of using mobile phone text messaging to reinforce learning and the practice of diabetic foot care in a developing country. Ongoing learning reinforcement (2-3 times weekly) by text messaging followed an informal class on diabetic foot care in a community clinic setting. Subjects with cell phone access and no history of diabetic foot wounds or current wounds were recruited for participation (N = 225). Foot examinations and pretesting by survey occurred just before patients departed the clinic; the posttest survey and a final foot examination occurred 12 weeks later. The survey included basic demographic items along with items to measure knowledge and current foot care practices. One sample t tests (raw scores) and Wilcoxon signed-rank tests compared knowledge and practice before and after intervention. Initially, a majority of the sample (76%) reported poor levels of foot care. After 12 weeks <1% reported poor foot care practices. Statistical testing showed significant gains in knowledge (by score and level) and nearly unanimous compliance with daily foot examination. Mobile phone text messaging is an economical, feasible, and effective method for educators to improve diabetic self-care, even in a developing country. © 2017 John Wiley & Sons Australia, Ltd.

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

PubMed Central

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

2017-01-01

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

Self-Monitoring Symptoms in Glaucoma: A Feasibility Study of a Web-Based Diary Tool

PubMed Central

McDonald, Leanne; Glen, Fiona C.; Taylor, Deanna J.

2017-01-01

Purpose. Glaucoma patients annually spend only a few hours in an eye clinic but spend more than 5000 waking hours engaged in everything else. We propose that patients could self-monitor changes in visual symptoms providing valuable between clinic information; we test the hypothesis that this is feasible using a web-based diary tool. Methods. Ten glaucoma patients with a range of visual field loss took part in an eight-week pilot study. After completing a series of baseline tests, volunteers were prompted to monitor symptoms every three days and complete a diary about their vision during daily life using a bespoke web-based diary tool. Response to an end of a study questionnaire about the usefulness of the exercise was a main outcome measure. Results. Eight of the 10 patients rated the monitoring scheme to be “valuable” or “very valuable.” Completion rate to items was excellent (96%). Themes from a qualitative synthesis of the diary entries related to behavioural aspects of glaucoma. One patient concluded that a constant focus on monitoring symptoms led to negative feelings. Conclusions. A web-based diary tool for monitoring self-reported glaucoma symptoms is practically feasible. The tool must be carefully designed to ensure participants are benefitting, and it is not increasing anxiety. PMID:28546876

Structural Integration as an Adjunct to Outpatient Rehabilitation for Chronic Nonspecific Low Back Pain: A Randomized Pilot Clinical Trial

PubMed Central

Jacobson, Eric E.; Meleger, Alec L.; Bonato, Paolo; Wayne, Peter M.; Langevin, Helene M.; Kaptchuk, Ted J.; Davis, Roger B.

2015-01-01

Structural Integration (SI) is an alternative method of manipulation and movement education. To obtain preliminary data on feasibility, effectiveness, and adverse events (AE), 46 outpatients from Boston area with chronic nonspecific low back pain (CNSLBP) were randomized to parallel treatment groups of SI plus outpatient rehabilitation (OR) versus OR alone. Feasibility data were acceptable except for low compliance with OR and lengthy recruitment time. Intent-to-treat data on effectiveness were analyzed by Wilcoxon rank sum, n = 23 per group. Median reductions in VAS Pain, the primary outcome, of −26 mm in SI + OR versus 0 in OR alone were not significantly different (P = 0.075). Median reductions in RMDQ, the secondary outcome, of −2 points in SI + OR versus 0 in OR alone were significantly different (P = 0.007). Neither the proportions of participants with nor the seriousness of AE were significantly different. SI as an adjunct to OR for CNSLBP is not likely to provide additional reductions in pain but is likely to augment short term improvements in disability with a low additional burden of AE. A more definitive trial is feasible, but OR compliance and recruitment might be challenging. This trial is registered with ClinicalTrials.gov (NCT01322399). PMID:25945112

The Empirical Foundations of Telepathology: Evidence of Feasibility and Intermediate Effects

PubMed Central

Krupinski, Elizabeth A.; Weinstein, Ronald S.; Dunn, Matthew R.; Bashshur, Noura

2017-01-01

Abstract Introduction: Telepathology evolved from video microscopy (i.e., “television microscopy”) research in the early 1950s to video microscopy used in basic research in the biological sciences to a basic diagnostic tool in telemedicine clinical applications. Its genesis can be traced to pioneering feasibility studies regarding the importance of color and other image-based parameters for rendering diagnoses and a series of studies assessing concordance of virtual slide and light microscopy diagnoses. This article documents the empirical foundations of telepathology. Methods: A selective review of the research literature during the past decade (2005–2016) was conducted using robust research design and adequate sample size as criteria for inclusion. Conclusions: The evidence regarding feasibility/acceptance of telepathology and related information technology applications has been well documented for several decades. The majority of evidentiary studies focused on intermediate outcomes, as indicated by comparability between telepathology and conventional light microscopy. A consistent trend of concordance between the two modalities was observed in terms of diagnostic accuracy and reliability. Additional benefits include use of telepathology and whole slide imaging for teaching, research, and outreach to resource-limited countries. Challenges still exist, however, in terms of use of telepathology as an effective diagnostic modality in clinical practice. PMID:28170313

Structural integration as an adjunct to outpatient rehabilitation for chronic nonspecific low back pain: a randomized pilot clinical trial.

PubMed

Jacobson, Eric E; Meleger, Alec L; Bonato, Paolo; Wayne, Peter M; Langevin, Helene M; Kaptchuk, Ted J; Davis, Roger B

2015-01-01

Structural Integration (SI) is an alternative method of manipulation and movement education. To obtain preliminary data on feasibility, effectiveness, and adverse events (AE), 46 outpatients from Boston area with chronic nonspecific low back pain (CNSLBP) were randomized to parallel treatment groups of SI plus outpatient rehabilitation (OR) versus OR alone. Feasibility data were acceptable except for low compliance with OR and lengthy recruitment time. Intent-to-treat data on effectiveness were analyzed by Wilcoxon rank sum, n = 23 per group. Median reductions in VAS Pain, the primary outcome, of -26 mm in SI + OR versus 0 in OR alone were not significantly different (P = 0.075). Median reductions in RMDQ, the secondary outcome, of -2 points in SI + OR versus 0 in OR alone were significantly different (P = 0.007). Neither the proportions of participants with nor the seriousness of AE were significantly different. SI as an adjunct to OR for CNSLBP is not likely to provide additional reductions in pain but is likely to augment short term improvements in disability with a low additional burden of AE. A more definitive trial is feasible, but OR compliance and recruitment might be challenging. This trial is registered with ClinicalTrials.gov (NCT01322399).

Using EHR audit trail logs to analyze clinical workflow: A case study from community-based ambulatory clinics.

PubMed

Wu, Danny T Y; Smart, Nikolas; Ciemins, Elizabeth L; Lanham, Holly J; Lindberg, Curt; Zheng, Kai

2017-01-01

To develop a workflow-supported clinical documentation system, it is a critical first step to understand clinical workflow. While Time and Motion studies has been regarded as the gold standard of workflow analysis, this method can be resource consuming and its data may be biased due to the cognitive limitation of human observers. In this study, we aimed to evaluate the feasibility and validity of using EHR audit trail logs to analyze clinical workflow. Specifically, we compared three known workflow changes from our previous study with the corresponding EHR audit trail logs of the study participants. The results showed that EHR audit trail logs can be a valid source for clinical workflow analysis, and can provide an objective view of clinicians' behaviors, multi-dimensional comparisons, and a highly extensible analysis framework.

Interobserver variability and feasibility of polymerase chain reaction-based assay in distinguishing ischemic colitis from Clostridium difficile colitis in endoscopic mucosal biopsies.

PubMed

Wiland, Homer O; Procop, Gary W; Goldblum, John R; Tuohy, Marion; Rybicki, Lisa; Patil, Deepa T

2013-06-01

Polymerase chain reaction (PCR)-based assays using stool samples are currently the most effective method of detecting Clostridium difficile. This study examines the feasibility of this assay using mucosal biopsy samples and evaluates the interobserver reproducibility in diagnosing and distinguishing ischemic colitis from C difficile colitis. Thirty-eight biopsy specimens were reviewed and classified by 3 observers into C difficile and ischemic colitis. The findings were correlated with clinical data. PCR was performed on 34 cases using BD GeneOhm C difficile assay. The histologic interobserver agreement was excellent (κ= 0.86) and the agreement between histologic and clinical diagnosis was good (κ = 0.84). All 19 ischemic colitis cases tested negative (100% specificity) and 3 of 15 cases of C difficile colitis tested positive (20% sensitivity). C difficile colitis can be reliably distinguished from ischemic colitis using histologic criteria. The C difficile PCR test on endoscopic biopsy specimens has excellent specificity but limited sensitivity.

Determining the impact of a new physiotherapist-led primary care model for back pain: protocol for a pilot cluster randomized controlled trial.

PubMed

Miller, Jordan; Barber, David; Donnelly, Catherine; French, Simon; Green, Michael; Hill, Jonathan; MacDermid, Joy; Marsh, Jacquelyn; Norman, Kathleen; Richardson, Julie; Taljaard, Monica; Wideman, Timothy; Cooper, Lynn; McPhee, Colleen

2017-11-09

Back pain is a leading contributor to disability, healthcare costs, and lost work. Family physicians are the most common first point of contact in the healthcare system for people with back pain, but physiotherapists (PTs) may be able to support the primary care team through evidence-based primary care. A cluster randomized trial is needed to determine the clinical, health system, and societal impact of a primary care model that integrates physiotherapists at the first visit for people with back pain. Prior to conducting a future fully powered cluster randomized trial, we need to demonstrate feasibility of the methods. Therefore, the purpose of this pilot study will be to: 1) Determine feasibility of patient recruitment, assessment procedures, and retention. 2) Determine the feasibility of training and implementation of a new PT-led primary care model for low back pain (LBP) 3) Explore the perspectives of patients and healthcare providers (HCPs) related to their experiences and attitudes towards the new service delivery model, barriers/facilitators to implementation, perceived satisfaction, perceived value, and impact on clinic processes and patient outcomes. This pilot cluster randomized controlled trial will enroll four sites and randomize them to implement a new PT-led primary care model for back pain or a usual physician-led primary care model. All adults booking a primary care visit for back pain will be invited to participate. Feasibility outcomes will include: recruitment and retention rates, completeness of assessment data, PT training participation and confidence after training, and PT treatment fidelity. Secondary outcomes will include the clinical, health system, cost, and process outcomes planned for the future fully powered cluster trial. Results will be analyzed and reported descriptively and qualitatively. To explore perspectives of both HCPs and patients, we will conduct semi-structured qualitative interviews with patients and focus groups with HCPs from participants in the PT-led primary care sites. If this pilot demonstrates feasibility, a fully powered trial will provide evidence that has the potential to transform primary care for back pain. The full trial will inform future service design, whether these models should be more widely implemented, and training agendas. ClinicalTrials.gov, NCT03320148 . Submitted for registration on 17 September 2017.

Molecular image-directed biopsies: improving clinical biopsy selection in patients with multiple tumors

NASA Astrophysics Data System (ADS)

Harmon, Stephanie A.; Tuite, Michael J.; Jeraj, Robert

2016-10-01

Site selection for image-guided biopsies in patients with multiple lesions is typically based on clinical feasibility and physician preference. This study outlines the development of a selection algorithm that, in addition to clinical requirements, incorporates quantitative imaging data for automatic identification of candidate lesions for biopsy. The algorithm is designed to rank potential targets by maximizing a lesion-specific score, incorporating various criteria separated into two categories: (1) physician-feasibility category including physician-preferred lesion location and absolute volume scores, and (2) imaging-based category including various modality and application-specific metrics. This platform was benchmarked in two clinical scenarios, a pre-treatment setting and response-based setting using imaging from metastatic prostate cancer patients with high disease burden (multiple lesions) undergoing conventional treatment and receiving whole-body [18F]NaF PET/CT scans pre- and mid-treatment. Targeting of metastatic lesions was robust to different weighting ratios and candidacy for biopsy was physician confirmed. Lesion ranked as top targets for biopsy remained so for all patients in pre-treatment and post-treatment biopsy selection after sensitivity testing was completed for physician-biased or imaging-biased scenarios. After identifying candidates, biopsy feasibility was evaluated by a physician and confirmed for 90% (32/36) of high-ranking lesions, of which all top choices were confirmed. The remaining cases represented lesions with high anatomical difficulty for targeting, such as proximity to sciatic nerve. This newly developed selection method was successfully used to quantitatively identify candidate lesions for biopsies in patients with multiple lesions. In a prospective study, we were able to successfully plan, develop, and implement this technique for the selection of a pre-treatment biopsy location.

Feasibility of a clinical trial of vision therapy for treatment of amblyopia.

PubMed

Lyon, Don W; Hopkins, Kristine; Chu, Raymond H; Tamkins, Susanna M; Cotter, Susan A; Melia, B Michele; Holmes, Jonathan M; Repka, Michael X; Wheeler, David T; Sala, Nicholas A; Dumas, Janette; Silbert, David I

2013-05-01

We conducted a pilot randomized clinical trial of office-based active vision therapy for the treatment of childhood amblyopia to determine the feasibility of conducting a full-scale randomized clinical trial. A training and certification program and manual of procedures were developed to certify therapists to administer a standardized vision therapy program in ophthalmology and optometry offices consisting of weekly visits for 16 weeks. Nineteen children, aged 7 to less than 13 years, with amblyopia (20/40-20/100) were randomly assigned to receive either 2 hours of daily patching with active vision therapy or 2 hours of daily patching with placebo vision therapy. Therapists in diverse practice settings were successfully trained and certified to perform standardized vision therapy in strict adherence with protocol. Subjects completed 85% of required weekly in-office vision therapy visits. Eligibility criteria based on age, visual acuity, and stereoacuity, designed to identify children able to complete a standardized vision therapy program and judged likely to benefit from this treatment, led to a high proportion of screened subjects being judged ineligible, resulting in insufficient recruitment. There were difficulties in retrieving adherence data for the computerized home therapy procedures. This study demonstrated that a 16-week treatment trial of vision therapy was feasible with respect to maintaining protocol adherence; however, recruitment under the proposed eligibility criteria, necessitated by the standardized approach to vision therapy, was not successful. A randomized clinical trial of in-office vision therapy for the treatment of amblyopia would require broadening of the eligibility criteria and improved methods to gather objective data regarding the home therapy. A more flexible approach that customizes vision therapy based on subject age, visual acuity, and stereopsis might be required to allow enrollment of a broader group of subjects.

Reaching clinically relevant outcome measures for new pharmacotherapy and immunotherapy of atopic eczema.

PubMed

Chalmers, Joanne; Deckert, Stefanie; Schmitt, Jochen

2015-06-01

This article describes the core outcome set (COS) for atopic eczema trials. COS describe a minimum set of outcomes to be assessed in a defined situation. COS are required to overcome the current situation of different trials using different endpoints with unclear/insufficient measurement properties resulting in incomparable trials. The global multi-stakeholder Harmonising Outcomes Measures for Eczema initiative developed the Harmonising Outcomes Measures for Eczema roadmap as a generic framework for COS development. Following the establishment of a panel representing all stakeholders, a core set of outcome domains need to be selected based on systematic reviews and consensus methods. Outcome measurement instruments to assess these core domains need to be valid, reliable, and feasible. There is broad global consensus that clinical signs, quality of life, symptoms, and long-term control of flares form the COS for atopic eczema trials. The Eczema Area and Severity Index is recommended to assess clinical signs in atopic eczema trials. Systematic reviews to identify adequate outcome measurement instruments for the other core outcome domains are underway. Clinical signs should be assessed in all atopic eczema trials by at least the Eczema Area and Severity Index. Quality of life, symptoms, and flares should also be assessed in all atopic eczema trials by a valid, reliable, and feasible instrument.

Haptic-Based Neurorehabilitation in Poststroke Patients: A Feasibility Prospective Multicentre Trial for Robotics Hand Rehabilitation

PubMed Central

Daud Albasini, Omar A.; Oboe, Roberto; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain. PMID:24319496

Haptic-based neurorehabilitation in poststroke patients: a feasibility prospective multicentre trial for robotics hand rehabilitation.

PubMed

Turolla, Andrea; Daud Albasini, Omar A; Oboe, Roberto; Agostini, Michela; Tonin, Paolo; Paolucci, Stefano; Sandrini, Giorgio; Venneri, Annalena; Piron, Lamberto

2013-01-01

Background. Haptic robots allow the exploitation of known motor learning mechanisms, representing a valuable option for motor treatment after stroke. The aim of this feasibility multicentre study was to test the clinical efficacy of a haptic prototype, for the recovery of hand function after stroke. Methods. A prospective pilot clinical trial was planned on 15 consecutive patients enrolled in 3 rehabilitation centre in Italy. All the framework features of the haptic robot (e.g., control loop, external communication, and graphic rendering for virtual reality) were implemented into a real-time MATLAB/Simulink environment, controlling a five-bar linkage able to provide forces up to 20 [N] at the end effector, used for finger and hand rehabilitation therapies. Clinical (i.e., Fugl-Meyer upper extremity scale; nine hold pegboard test) and kinematics (i.e., time; velocity; jerk metric; normalized jerk of standard movements) outcomes were assessed before and after treatment to detect changes in patients' motor performance. Reorganization of cortical activation was detected in one patient by fMRI. Results and Conclusions. All patients showed significant improvements in both clinical and kinematic outcomes. Additionally, fMRI results suggest that the proposed approach may promote a better cortical activation in the brain.

Clinical usefulness and feasibility of time-frequency analysis of chemosensory event-related potentials.

PubMed

Huart, C; Rombaux, Ph; Hummel, T; Mouraux, A

2013-09-01

The clinical usefulness of olfactory event-related brain potentials (OERPs) to assess olfactory function is limited by the relatively low signal-to-noise ratio of the responses identified using conventional time-domain averaging. Recently, it was shown that time-frequency analysis of the obtained EEG signals can markedly improve the signal-to-noise ratio of OERPs in healthy controls, because it enhances both phase-locked and non phase-locked EEG responses. The aim of the present study was to investigate the clinical usefulness of this approach and evaluate its feasibility in a clinical setting. We retrospectively analysed EEG recordings obtained from 45 patients (15 anosmic, 15 hyposmic and 15 normos- mic). The responses to olfactory stimulation were analysed using conventional time-domain analysis and joint time-frequency analysis. The ability of the two methods to discriminate between anosmic, hyposmic and normosmic patients was assessed using a Receiver Operating Characteristic analysis. The discrimination performance of OERPs identified using conventional time-domain averaging was poor. In contrast, the discrimination performance of the EEG response identified in the time-frequency domain was relatively high. Furthermore, we found a significant correlation between the magnitude of this response and the psychophysical olfactory score. Time-frequency analysis of the EEG responses to olfactory stimulation could be used as an effective and reliable diagnostic tool for the objective clinical evaluation of olfactory function in patients.

Cardiovascular self-management support program for preventing cardiovascular complication behaviors and clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus in Indonesia: A pilot study.

PubMed

Hisni, Dayan; Rukmaini, Rukmaini; Saryono, Saryono; Chinnawong, Tippamas; Thaniwattananon, Ploenpit

2018-03-06

The aim of the study was to determine the feasibility, and to evaluate the effect of, a cardiovascular self-management support program by applying the 5A's self-management support program on preventing cardiovascular complication behaviors and to assess the clinical outcomes in the elderly with poorly controlled type 2 diabetes mellitus (DM). This pilot study used a quasi-experimental study design. Twelve elderly persons with poorly controlled type 2 DM were assigned into either a control or experimental group, with six participants in each group. The Preventing Cardiovascular Complication Behaviors (PCCB) was measured by the Preventing Cardiovascular Complication Behaviors Questionnaire, while the clinical outcomes were measured by clinical devices that were provided. These measurements were conducted and compared at baseline and 6 weeks after the completion of the program. The self-management support program was a 6 week program with several implementation methods, based on the 5A's self-management support program. The participants who received the cardiovascular self-management support program reported a significant improvement in their PCCB and clinical outcomes, compared to those receiving the usual care. This study revealed that a cardiovascular self-management support program that applies the 5A's self-management support program is feasible for implementation. © 2018 Japan Academy of Nursing Science.

Holding up a mirror: changing obstetric practice through criterion-based clinical audit in developing countries.

PubMed

Wagaarachchi, P T; Graham, W J; Penney, G C; McCaw-Binns, A; Yeboah Antwi, K; Hall, M H

2001-08-01

The objective of the study described is to assess the feasibility and effectiveness of using a criterion-based clinical audit to measure and improve the quality of obstetric care at the district hospital level in developing countries. The focus is on the management of five life-threatening obstetric complications--hemorrhage, eclampsia, genital tract infection, obstructed labor and uterine rupture was audited using a "before and after" design. The five steps of the audit cycle were followed: establish criteria of good quality care; measure current practice (Review I); feedback findings and set targets; take action to change practice; and re-evaluate practice (Review II). Systematic literature review, panel discussions and pilot work led to the development of 31 audit criteria. Review I included 555 life-threatening complications occurring over 66 hospital-months; Review II included 342 complications over 42 hospital-months. Many common areas for improvement were identified across the four hospitals. Agreed mechanisms for achieving these improvements included clinical protocols, reviews of staffing, and training workshops. Some aspects of clinical monitoring, drug use and record keeping improved significantly between Reviews I and II. Criterion-based clinical audit in four typical district hospitals in Ghana and Jamaica is a feasible and acceptable method for quality assurance and appears to have improved the management of life-threatening obstetric complications.

The Feasibility of Administering a Practical Clinical Examination in Podiatry at a College of Podiatric Medicine: Results of a Field Trial Under Simulated Part III Test Conditions.

ERIC Educational Resources Information Center

And Others; Valletta, Michael

1978-01-01

The results of a practical clinical examination in podiatric medicine administered to fourth-year students are presented. The examination could become the prototype of a Part III practical clinical examination under the auspices of the National Board of Podiatry Examiners. Its feasibility is established and problems and issues are discussed.…

Source-based neurofeedback methods using EEG recordings: training altered brain activity in a functional brain source derived from blind source separation

PubMed Central

White, David J.; Congedo, Marco; Ciorciari, Joseph

2014-01-01

A developing literature explores the use of neurofeedback in the treatment of a range of clinical conditions, particularly ADHD and epilepsy, whilst neurofeedback also provides an experimental tool for studying the functional significance of endogenous brain activity. A critical component of any neurofeedback method is the underlying physiological signal which forms the basis for the feedback. While the past decade has seen the emergence of fMRI-based protocols training spatially confined BOLD activity, traditional neurofeedback has utilized a small number of electrode sites on the scalp. As scalp EEG at a given electrode site reflects a linear mixture of activity from multiple brain sources and artifacts, efforts to successfully acquire some level of control over the signal may be confounded by these extraneous sources. Further, in the event of successful training, these traditional neurofeedback methods are likely influencing multiple brain regions and processes. The present work describes the use of source-based signal processing methods in EEG neurofeedback. The feasibility and potential utility of such methods were explored in an experiment training increased theta oscillatory activity in a source derived from Blind Source Separation (BSS) of EEG data obtained during completion of a complex cognitive task (spatial navigation). Learned increases in theta activity were observed in two of the four participants to complete 20 sessions of neurofeedback targeting this individually defined functional brain source. Source-based EEG neurofeedback methods using BSS may offer important advantages over traditional neurofeedback, by targeting the desired physiological signal in a more functionally and spatially specific manner. Having provided preliminary evidence of the feasibility of these methods, future work may study a range of clinically and experimentally relevant brain processes where individual brain sources may be targeted by source-based EEG neurofeedback. PMID:25374520

Development and initial evaluation of an instrument to assess physiotherapists' clinical reasoning focused on clients' behavior change.

PubMed

Elvén, Maria; Hochwälder, Jacek; Dean, Elizabeth; Söderlund, Anne

2018-05-01

A systematically developed and evaluated instrument is needed to support investigations of physiotherapists' clinical reasoning integrated with the process of clients' behavior change. This study's aim was to develop an instrument to assess physiotherapy students' and physiotherapists' clinical reasoning focused on clients' activity-related behavior and behavior change, and initiate its evaluation, including feasibility and content validity. The study was conducted in three phases: 1) determination of instrument structure and item generation, based on a model, guidelines for assessing clinical reasoning, and existing measures; 2) cognitive interviews with five physiotherapy students to evaluate item understanding and feasibility; and 3) a Delphi process with 18 experts to evaluate content relevance. Phase 1 resulted in an instrument with four domains: Physiotherapist; Input from client; Functional behavioral analysis; and Strategies for behavior change. The instrument consists of case scenarios followed by items in which key features are identified, prioritized, or interpreted. Phase 2 resulted in revisions of problems and approval of feasibility. Phase 3 demonstrated high level of consensus regarding the instrument's content relevance. This feasible and content-validated instrument shows potential for use in investigations of physiotherapy students' and physiotherapists' clinical reasoning, however continued development and testing are needed.

Feasibility of task-specific brain-machine interface training for upper-extremity paralysis in patients with chronic hemiparetic stroke.

PubMed

Nishimoto, Atsuko; Kawakami, Michiyuki; Fujiwara, Toshiyuki; Hiramoto, Miho; Honaga, Kaoru; Abe, Kaoru; Mizuno, Katsuhiro; Ushiba, Junichi; Liu, Meigen

2018-01-10

Brain-machine interface training was developed for upper-extremity rehabilitation for patients with severe hemiparesis. Its clinical application, however, has been limited because of its lack of feasibility in real-world rehabilitation settings. We developed a new compact task-specific brain-machine interface system that enables task-specific training, including reach-and-grasp tasks, and studied its clinical feasibility and effectiveness for upper-extremity motor paralysis in patients with stroke. Prospective beforeâ€"after study. Twenty-six patients with severe chronic hemiparetic stroke. Participants were trained with the brain-machine interface system to pick up and release pegs during 40-min sessions and 40 min of standard occupational therapy per day for 10 days. Fugl-Meyer upper-extremity motor (FMA) and Motor Activity Log-14 amount of use (MAL-AOU) scores were assessed before and after the intervention. To test its feasibility, 4 occupational therapists who operated the system for the first time assessed it with the Quebec User Evaluation of Satisfaction with assistive Technology (QUEST) 2.0. FMA and MAL-AOU scores improved significantly after brain-machine interface training, with the effect sizes being medium and large, respectively (p<0.01, d=0.55; p<0.01, d=0.88). QUEST effectiveness and safety scores showed feasibility and satisfaction in the clinical setting. Our newly developed compact brain-machine interface system is feasible for use in real-world clinical settings.

SU-G-IeP3-10: Molecular Imaging with Clinical X-Ray Sources and Compton Cameras

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

Vernekohl, D; Ahmad, M; Chinn, G

2016-06-15

Purpose: The application of Compton cameras (CC) is a novel approach translating XFCT to a practical modality realized with clinical CT systems without the restriction of pencil beams. The dual modality design offers additional information without extra patient dose. The purpose of this work is to investigate the feasibility and efficacy of using CCs for volumetric x-ray fluorescence (XF) imaging by Monte Carlo (MC) simulations and statistical image reconstruction. Methods: The feasibility of a CC for imaging x-ray fluorescence emitted from targeted lesions is examined by MC simulations. 3 mm diameter water spheres with various gold concentrations and detector distancesmore » are placed inside the lung of an adult human phantom (MIRD) and are irradiated with both fan and cone-beam geometries. A sandwich design CC composed of Silicon and CdTe is used to image the gold nanoparticle distribution. The detection system comprises four 16×26 cm{sup 2} detector panels placed on the chest of a MIRD phantom. Constraints of energy-, spatial-resolution, clinical geometries and Doppler broadening are taken into account. Image reconstruction is performed with a list-mode MLEM algorithm with cone-projector on a GPU. Results: The comparison of reconstruction of cone- and fan-beam excitation shows that the spatial resolution is improved by 23% for fan-beams with significantly decreased processing time. Cone-beam excitation increases scatter content disturbing quantification of lesions near the body surface. Spatial resolution and detectability limit in the center of the lung is 8.7 mm and 20 fM for 50 nm diameter gold nanoparticles at 20 mGy. Conclusion: The implementation of XFCT with a CC is a feasible method for molecular imaging with high atomic number probes. Given constrains of detector resolutions, Doppler broadening, and limited exposure dose, spatial resolutions comparable with PET and molecular sensitivities in the fM range are realizable with current detector technology.« less

Development and feasibility of the misuse, abuse, and diversion drug event reporting system (MADDERS®).

PubMed

Treister, Roi; Trudeau, Jeremiah J; Van Inwegen, Richard; Jones, Judith K; Katz, Nathaniel P

2016-12-01

Inappropriate use of analgesic drugs has become increasingly pervasive over the past decade. Currently, drug abuse potential is primarily assessed post-marketing; no validated tools are available to assess this potential in phase II and III clinical trials. This paper describes the development and feasibility testing of a Misuse, Abuse, and Diversion Drug Event Reporting System (MADDERS), which aims to identify potentially abuse-related events and classify them according to a recently developed classification scheme, allowing the quantification of these events in clinical trials. The system was initially conceived and designed with input from experts and patients, followed by field-testing to assess its feasibility and content validity in both completed and ongoing clinical trials. The results suggest that MADDERS is a feasible system with initial validity. It showed higher rates of the triggering events in subjects taking medications with known abuse potential than in patients taking medications without abuse potential. Additionally, experts agreed on the classification of most abuse-related events in MADDERS. MADDERS is a new systematic approach to collect information on potentially abuse-related events in clinical trials and classify them. The system has demonstrated feasibility for implementation. Additional research is ongoing to further evaluate its validity. Currently, there are no validated tools to assess drug abuse potential during clinical trials. Because of its ease of implementation, its systematic approach, and its preliminary validation results, MADDERS could provide such a tool for clinical trials. (Am J Addict 2016;25:641-651). © 2016 American Academy of Addiction Psychiatry.

Validation of DESS as a DNA Preservation Method for the Detection of Strongyloides spp. in Canine Feces.

PubMed

Beknazarova, Meruyert; Millsteed, Shelby; Robertson, Gemma; Whiley, Harriet; Ross, Kirstin

2017-06-09

Strongyloides stercoralis is a gastrointestinal parasitic nematode with a life cycle that includes free-living and parasitic forms. For both clinical (diagnostic) and environmental evaluation, it is important that we can detect Strongyloides spp. in both human and non-human fecal samples. Real-time PCR is the most feasible method for detecting the parasite in both clinical and environmental samples that have been preserved. However, one of the biggest challenges with PCR detection is DNA degradation during the postage time from rural and remote areas to the laboratory. This study included a laboratory assessment and field validation of DESS (dimethyl sulfoxide, disodium EDTA, and saturated NaCl) preservation of Strongyloides spp. DNA in fecal samples. The laboratory study investigated the capacity of 1:1 and 1:3 sample to DESS ratios to preserve Strongyloides ratti in spike canine feces. It was found that both ratios of DESS significantly prevented DNA degradation compared to the untreated sample. This method was then validated by applying it to the field-collected canine feces and detecting Strongyloides DNA using PCR. A total of 37 canine feces samples were collected and preserved in the 1:3 ratio (sample: DESS) and of these, 17 were positive for Strongyloides spp. The study shows that both 1:1 and 1:3 sample to DESS ratios were able to preserve the Strongyloides spp. DNA in canine feces samples stored at room temperature for up to 56 days. This DESS preservation method presents the most applicable and feasible method for the Strongyloides DNA preservation in field-collected feces.

The CNDR: collaborating to translate new therapies for Canadians.

PubMed

Korngut, Lawrence; Campbell, Craig; Johnston, Megan; Benstead, Timothy; Genge, Angela; Mackenzie, Alex; McCormick, Anna; Biggar, Douglas; Bourque, Pierre; Briemberg, Hannah; O'Connell, Colleen; Dojeiji, Suzan; Dooley, Joseph; Grant, Ian; Hogan, Gillian; Johnston, Wendy; Kalra, Sanjay; Katzberg, Hans D; Mah, Jean K; McAdam, Laura; McMillan, Hugh J; Melanson, Michel; Selby, Kathryn; Shoesmith, Christen; Smith, Garth; Venance, Shannon L; Wee, Joy

2013-09-01

Patient registries represent an important method of organizing "real world" patient information for clinical and research purposes. Registries can facilitate clinical trial planning and recruitment and are particularly useful in this regard for uncommon and rare diseases. Neuromuscular diseases (NMDs) are individually rare but in aggregate have a significant prevalence. In Canada, information on NMDs is lacking. Barriers to performing Canadian multicentre NMD research exist which can be overcome by a comprehensive and collaborative NMD registry. We describe the objectives, design, feasibility and initial recruitment results for the Canadian Neuromuscular Disease Registry (CNDR). The CNDR is a clinic-based registry which launched nationally in June 2011, incorporates paediatric and adult neuromuscular clinics in British Columbia, Alberta, Ontario, Quebec, New Brunswick and Nova Scotia and, as of December 2012, has recruited 1161 patients from 12 provinces and territories. Complete medical datasets have been captured on 460 "index disease" patients. Another 618 "non-index" patients have been recruited with capture of physician-confirmed diagnosis and contact information. We have demonstrated the feasibility of blended clinic and central office-based recruitment. "Index disease" patients recruited at the time of writing include 253 with Duchenne and Becker muscular dystrophy, 161 with myotonic dystrophy, and 71 with ALS. The CNDR is a new nationwide registry of patients with NMDs that represents an important advance in Canadian neuromuscular disease research capacity. It provides an innovative platform for organizing patient information to facilitate clinical research and to expedite translation of recent laboratory findings into human studies.

Evaluating Integrative Cancer Clinics With the Claim Assessment Profile: An Example With the InspireHealth Clinic.

PubMed

Hilton, Lara; Elfenbaum, Pamela; Jain, Shamini; Sprengel, Meredith; Jonas, Wayne B

2018-03-01

The evaluation of freestanding integrative cancer clinical programs is challenging and is rarely done. We have developed an approach called the Claim Assessment Profile (CAP) to identify whether evaluation of a practice is justified, feasible, and likely to provide useful information. A CAP was performed in order to (1) clarify the healing claims at InspireHealth, an integrative oncology treatment program, by defining the most important impacts on its clients; (2) gather information about current research capacity at the clinic; and (3) create a program theory and path model for use in prospective research. This case study design incorporates methods from a variety of rapid assessment approaches. Procedures included site visits to observe the program, structured qualitative interviews with 26 providers and staff, surveys to capture descriptive data about the program, and observational data on program implementation. The InspireHealth program is a well-established, multi-site, thriving integrative oncology clinical practice that focuses on patient support, motivation, and health behavior engagement. It delivers patient-centered care via a standardized treatment protocol. There arehigh levels of research interest from staff and resources by which to conduct research. This analysis provides the primary descriptive and claims clarification of an integrative oncology treatment program, an evaluation readiness report, a detailed logic model explicating program theory, and a clinical outcomes path model for conducting prospective research. Prospective evaluation of this program would be feasible and valuable, adding to our knowledge base of integrative cancer therapies.

Bidirectional Text Messaging to Improve Adherence to Recommended Lipid Testing.

PubMed

Baldwin, Laura-Mae; Morrison, Caitlin; Griffin, Jonathan; Anderson, Nick; Edwards, Kelly; Green, Jeff; Waldren, Cleary; Reiter, William

2017-01-01

Synergies between technology and health care in the United States are accelerating, increasing opportunities to leverage these technologies to improve patient care. This study was a collaboration between an academic study team, a rural primary care clinic, and a local nonprofit informatics company developing tools to improve patient care through population management. Our team created a text messaging management tool, then developed methods for and tested the feasibility of bidirectional text messaging to remind eligible patients about the need for lipid testing. We measured patient response to the text messages, then interviewed 8 patients to explore their text messaging experience. Of the 129 patients the clinic was able to contact by phone, 29.4% had no cell phone or text-messaging capabilities. An additional 20% refused to participate. Two thirds of the 28 patients who participated in the text messaging intervention (67.9%) responded to at least 1 of the up to 3 messages. Seven of 8 interviewed patients had a positive text-messaging experience. Bidirectional text messaging is a feasible and largely acceptable form of communication for test reminders that has the potential to reach large numbers of patients in clinical care. © Copyright 2017 by the American Board of Family Medicine.

Fully Integrated e-Services for Prevention, Diagnosis, and Treatment of Sexually Transmitted Infections: Results of a 4-County Study in California

PubMed Central

Levy, Vivian; Lensing, Shelly; Chattopadhyay, Ishita; Venkatasubramanian, Lalitha; Acevedo, Nincoshka; Wolff, Peter; Callabresi, Debra; Philip, Susan; Lopez, Teresa P.; Padian, Nancy; Blake, Diane R.; Gaydos, Charlotte A.

2014-01-01

Objectives. We examined the acceptability, feasibility, and cost of a fully integrated online system (eSTI) for sexually transmitted infection (STI) testing, treatment, and linkage to care with 4 Northern California health departments. Methods. In April 2012, we implemented the eSTI system, which provided education; testing of self-collected vaginal swabs for chlamydia, gonorrhea, and trichomoniasis; e-prescriptions; e-partner notification; and data integration with clinic electronic health records. We analyzed feasibility, acceptability, and cost measures. Results. During a 3-month period, 217 women aged 18 to 30 years enrolled; 67% returned the kit. Of these, 92% viewed their results online. STI prevalence was 5.6% (chlamydia and trichomoniasis). All participants with STIs received treatment either the same day at a pharmacy (62%) or within 7 days at a clinic (38%). Among participants completing follow-up surveys, 99% would recommend the online eSTI system to a friend, and 95% preferred it over clinic-based testing within a study. Conclusions. The fully integrated eSTI system has the potential to increase diagnosis and treatment of STIs with higher patient satisfaction at a potentially lower cost. PMID:25320878

Disability and Fatigue Can Be Objectively Measured in Multiple Sclerosis

PubMed Central

Motta, Caterina; Palermo, Eduardo; Studer, Valeria; Germanotta, Marco; Germani, Giorgio; Centonze, Diego; Cappa, Paolo

2016-01-01

Background The available clinical outcome measures of disability in multiple sclerosis are not adequately responsive or sensitive. Objective To investigate the feasibility of inertial sensor-based gait analysis in multiple sclerosis. Methods A cross-sectional study of 80 multiple sclerosis patients and 50 healthy controls was performed. Lower-limb kinematics was evaluated by using a commercially available magnetic inertial measurement unit system. Mean and standard deviation of range of motion (mROM, sROM) for each joint of lower limbs were calculated in one minute walking test. A motor performance index (E) defined as the sum of sROMs was proposed. Results We established two novel observer-independent measures of disability. Hip mROM was extremely sensitive in measuring lower limb motor impairment, being correlated with muscle strength and also altered in patients without clinically detectable disability. On the other hand, E index discriminated patients according to disability, being altered only in patients with moderate and severe disability, regardless of walking speed. It was strongly correlated with fatigue and patient-perceived health status. Conclusions Inertial sensor-based gait analysis is feasible and can detect clinical and subclinical disability in multiple sclerosis. PMID:26863109

Vertebral rotation measurement: a summary and comparison of common radiographic and CT methods

PubMed Central

Lam, Gabrielle C; Hill, Doug L; Le, Lawrence H; Raso, Jim V; Lou, Edmond H

2008-01-01

Current research has provided a more comprehensive understanding of Adolescent Idiopathic Scoliosis (AIS) as a three-dimensional spinal deformity, encompassing both lateral and rotational components. Apart from quantifying curve severity using the Cobb angle, vertebral rotation has become increasingly prominent in the study of scoliosis. It demonstrates significance in both preoperative and postoperative assessment, providing better appreciation of the impact of bracing or surgical interventions. In the past, the need for computer resources, digitizers and custom software limited studies of rotation to research performed after a patient left the scoliosis clinic. With advanced technology, however, rotation measurements are now more feasible. While numerous vertebral rotation measurement methods have been developed and tested, thorough comparisons of these are still relatively unexplored. This review discusses the advantages and disadvantages of six common measurement techniques based on technology most pertinent in clinical settings: radiography (Cobb, Nash-Moe, Perdriolle and Stokes' method) and computer tomography (CT) imaging (Aaro-Dahlborn and Ho's method). Better insight into the clinical suitability of rotation measurement methods currently available is presented, along with a discussion of critical concerns that should be addressed in future studies and development of new methods. PMID:18976498

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

Khosla, D.; Singh, M.

The estimation of three-dimensional dipole current sources on the cortical surface from the measured magnetoencephalogram (MEG) is a highly under determined inverse problem as there are many {open_quotes}feasible{close_quotes} images which are consistent with the MEG data. Previous approaches to this problem have concentrated on the use of weighted minimum norm inverse methods. While these methods ensure a unique solution, they often produce overly smoothed solutions and exhibit severe sensitivity to noise. In this paper we explore the maximum entropy approach to obtain better solutions to the problem. This estimation technique selects that image from the possible set of feasible imagesmore » which has the maximum entropy permitted by the information available to us. In order to account for the presence of noise in the data, we have also incorporated a noise rejection or likelihood term into our maximum entropy method. This makes our approach mirror a Bayesian maximum a posteriori (MAP) formulation. Additional information from other functional techniques like functional magnetic resonance imaging (fMRI) can be incorporated in the proposed method in the form of a prior bias function to improve solutions. We demonstrate the method with experimental phantom data from a clinical 122 channel MEG system.« less

Agile Acceptance Test–Driven Development of Clinical Decision Support Advisories: Feasibility of Using Open Source Software

PubMed Central

Baldwin, Krystal L; Kannan, Vaishnavi; Flahaven, Emily L; Parks, Cassandra J; Ott, Jason M; Willett, Duwayne L

2018-01-01

Background Moving to electronic health records (EHRs) confers substantial benefits but risks unintended consequences. Modern EHRs consist of complex software code with extensive local configurability options, which can introduce defects. Defects in clinical decision support (CDS) tools are surprisingly common. Feasible approaches to prevent and detect defects in EHR configuration, including CDS tools, are needed. In complex software systems, use of test–driven development and automated regression testing promotes reliability. Test–driven development encourages modular, testable design and expanding regression test coverage. Automated regression test suites improve software quality, providing a “safety net” for future software modifications. Each automated acceptance test serves multiple purposes, as requirements (prior to build), acceptance testing (on completion of build), regression testing (once live), and “living” design documentation. Rapid-cycle development or “agile” methods are being successfully applied to CDS development. The agile practice of automated test–driven development is not widely adopted, perhaps because most EHR software code is vendor-developed. However, key CDS advisory configuration design decisions and rules stored in the EHR may prove amenable to automated testing as “executable requirements.” Objective We aimed to establish feasibility of acceptance test–driven development of clinical decision support advisories in a commonly used EHR, using an open source automated acceptance testing framework (FitNesse). Methods Acceptance tests were initially constructed as spreadsheet tables to facilitate clinical review. Each table specified one aspect of the CDS advisory’s expected behavior. Table contents were then imported into a test suite in FitNesse, which queried the EHR database to automate testing. Tests and corresponding CDS configuration were migrated together from the development environment to production, with tests becoming part of the production regression test suite. Results We used test–driven development to construct a new CDS tool advising Emergency Department nurses to perform a swallowing assessment prior to administering oral medication to a patient with suspected stroke. Test tables specified desired behavior for (1) applicable clinical settings, (2) triggering action, (3) rule logic, (4) user interface, and (5) system actions in response to user input. Automated test suite results for the “executable requirements” are shown prior to building the CDS alert, during build, and after successful build. Conclusions Automated acceptance test–driven development and continuous regression testing of CDS configuration in a commercial EHR proves feasible with open source software. Automated test–driven development offers one potential contribution to achieving high-reliability EHR configuration. Vetting acceptance tests with clinicians elicits their input on crucial configuration details early during initial CDS design and iteratively during rapid-cycle optimization. PMID:29653922

A risk-management approach for effective integration of biomarkers in clinical trials: perspectives of an NCI, NCRI, and EORTC working group.

PubMed

Hall, Jacqueline Anne; Salgado, Roberto; Lively, Tracy; Sweep, Fred; Schuh, Anna

2014-04-01

Clinical cancer research today often includes testing the value of biomarkers to direct treatment and for drug development. However, the practical challenges of integration of molecular information into clinical trial protocols are increasingly appreciated. Inherent difficulties include evidence gaps in available biomarker data, a paucity of robust assay methods, and the design of appropriate studies within the constraints of feasible trial operations, and finite resources. Scalable and proportionate approaches are needed to systematically cope with these challenges. Therefore, we assembled international experts from three clinical trials organisations to identify the common challenges and common solutions. We present a practical risk-assessment framework allowing targeting of scarce resources to crucial issues coupled with a library of useful resources and a simple actionable checklist of recommendations. We hope that these practical methods will be useful for running biomarker-driven trials and ultimately help to develop biomarkers that are ready for integration in routine practice. Copyright © 2014 Elsevier Ltd. All rights reserved.

Integrated Analysis of Pharmacologic, Clinical, and SNP Microarray Data using Projection onto the Most Interesting Statistical Evidence with Adaptive Permutation Testing

PubMed Central

Pounds, Stan; Cao, Xueyuan; Cheng, Cheng; Yang, Jun; Campana, Dario; Evans, William E.; Pui, Ching-Hon; Relling, Mary V.

2010-01-01

Powerful methods for integrated analysis of multiple biological data sets are needed to maximize interpretation capacity and acquire meaningful knowledge. We recently developed Projection Onto the Most Interesting Statistical Evidence (PROMISE). PROMISE is a statistical procedure that incorporates prior knowledge about the biological relationships among endpoint variables into an integrated analysis of microarray gene expression data with multiple biological and clinical endpoints. Here, PROMISE is adapted to the integrated analysis of pharmacologic, clinical, and genome-wide genotype data that incorporating knowledge about the biological relationships among pharmacologic and clinical response data. An efficient permutation-testing algorithm is introduced so that statistical calculations are computationally feasible in this higher-dimension setting. The new method is applied to a pediatric leukemia data set. The results clearly indicate that PROMISE is a powerful statistical tool for identifying genomic features that exhibit a biologically meaningful pattern of association with multiple endpoint variables. PMID:21516175

Accuracy verification and identification of matrix effects. The College of American Pathologists' Protocol.

PubMed

Eckfeldt, J H; Copeland, K R

1993-04-01

Proficiency testing using stabilized control materials has been used for decades as a means of monitoring and improving performance in the clinical laboratory. Often, the commonly used proficiency testing materials exhibit "matrix effects" that cause them to behave differently from fresh human specimens in certain clinical analytic systems. Because proficiency testing is the primary method in which regulatory agencies have chosen to evaluate clinical laboratory performance, the College of American Pathologists (CAP) has proposed guidelines for investigating the influence of matrix effects on their Survey results. The purpose of this investigation was to determine the feasibility, usefulness, and potential problems associated with this CAP Matrix Effect Analytical Protocol, in which fresh patient specimens and CAP proficiency specimens are analyzed simultaneously by a field method and a definitive, reference, or other comparative method. The optimal outcome would be that both the fresh human and CAP Survey specimens agree closely with the comparative method result. However, this was not always the case. Using several different analytic configurations, we were able to demonstrate matrix and calibration biases for several of the analytes investigated.

Evaluating the feasibility and uptake of a community-led HIV testing and multi-disease health campaign in rural Uganda

PubMed Central

Kabami, Jane; Chamie, Gabriel; Kwarisiima, Dalsone; Biira, Edith; Ssebutinde, Peter; Petersen, Maya; Charlebois, Edwin D.; Kamya, Moses R.; Havlir, Diane V.; Clark, Tamara D.

2017-01-01

Abstract Introduction: Multi-disease community health campaigns can be effective for population-wide HIV testing in a research setting (SEARCH: NCT01864603). We sought to evaluate feasibility and uptake of a community-led health campaign (CLHC) planned and implemented by village leaders and local clinic workers in Uganda. Methods: Over five months in 2014, locally elected village leaders and Ministry of Health (MoH) clinic staff in a rural parish in Uganda planned a census followed by a CLHC, after training by two SEARCH trial consultants and by leaders from a neighbouring parish that had previously participated in a SEARCH health campaign. We defined feasibility as: (1) elected leaders’ participation in training and implementation of pre-campaign census and mobilization activities; (2) implementation of all campaign activities by MoH-funded, local clinic staff; and (3) community participation in the campaign, including point-of-care screening for HIV, malaria, hypertension and diabetes, and same-day referral for male circumcision and family planning (FP). Costing of all salaries and supplies was conducted. Results: Elected leaders from all eight villages in the parish participated in CLHC training. They and local clinic staff met monthly to select and plan CLHC services. Village leaders then leveraged existing volunteer health teams to perform a door-to-door census, enumerating 5,202 parish residents over 2 weeks. 2,753 (53%) residents participated in the 6-day CLHC. Of 1,584 adult participants, 1,474 (93%) tested for HIV: 105/1,474 (7.1%) tested HIV positive. 27% (751/2,753) of participants reported fever and underwent malaria rapid diagnostic testing: 5.3% (40/751) tested positive. Among adults screened, 19% (271/1,452) were hypertensive, and 3% (18/637) had a random blood sugar >11.1 mmol/L. Of 805 men and boys (>10 years), 91 (11%) accepted same-day clinic referral and underwent medical circumcision. Of 900 women offered same-day long-term FP referrals, 25 accepted. The CLHC cost, including census, mobilization and testing services, was $23,597 ($8.57/participant). Conclusions: Elected village leaders successfully planned and conducted a 6-day multi-disease health campaign with service provision by local clinic staff that reached over half of a rural Ugandan community. These data suggest it is feasible for local leaders and clinics to adopt a multi-disease health campaign approach to scale-up HIV testing in rural Africa. PMID:28406269

Recruiting Pregnant Patients for Survey Research: A Head to Head Comparison of Social Media-Based Versus Clinic-Based Approaches.

PubMed

Admon, Lindsay; Haefner, Jessica K; Kolenic, Giselle E; Chang, Tammy; Davis, Matthew M; Moniz, Michelle H

2016-12-21

Recruiting a diverse sample of pregnant women for clinical research is a challenging but crucial task for improving obstetric services and maternal and child health outcomes. To compare the feasibility and cost of recruiting pregnant women for survey research using social media-based and clinic-based approaches. Advertisements were used to recruit pregnant women from the social media website Facebook. In-person methods were used to recruit pregnant women from the outpatient clinic of a large, tertiary care center. In both approaches, potential respondents were invited to participate in a 15-minute Web-based survey. Each recruitment method was monitored for 1 month. Using bivariate statistics, we compared the number, demographic characteristics, and health characteristics of women recruited and the cost per completed survey for each recruitment method. The social media-based approach recruited 1178 women and the clinic-based approach recruited 219 women. A higher proportion of subjects recruited through social media identified as African American (29.4%, 207/705 vs 11.2%, 20/179), reported household incomes

3D automatic anatomy segmentation based on iterative graph-cut-ASM.

PubMed

Chen, Xinjian; Bagci, Ulas

2011-08-01

This paper studies the feasibility of developing an automatic anatomy segmentation (AAS) system in clinical radiology and demonstrates its operation on clinical 3D images. The AAS system, the authors are developing consists of two main parts: object recognition and object delineation. As for recognition, a hierarchical 3D scale-based multiobject method is used for the multiobject recognition task, which incorporates intensity weighted ball-scale (b-scale) information into the active shape model (ASM). For object delineation, an iterative graph-cut-ASM (IGCASM) algorithm is proposed, which effectively combines the rich statistical shape information embodied in ASM with the globally optimal delineation capability of the GC method. The presented IGCASM algorithm is a 3D generalization of the 2D GC-ASM method that they proposed previously in Chen et al. [Proc. SPIE, 7259, 72590C1-72590C-8 (2009)]. The proposed methods are tested on two datasets comprised of images obtained from 20 patients (10 male and 10 female) of clinical abdominal CT scans, and 11 foot magnetic resonance imaging (MRI) scans. The test is for four organs (liver, left and right kidneys, and spleen) segmentation, five foot bones (calcaneus, tibia, cuboid, talus, and navicular). The recognition and delineation accuracies were evaluated separately. The recognition accuracy was evaluated in terms of translation, rotation, and scale (size) error. The delineation accuracy was evaluated in terms of true and false positive volume fractions (TPVF, FPVF). The efficiency of the delineation method was also evaluated on an Intel Pentium IV PC with a 3.4 GHZ CPU machine. The recognition accuracies in terms of translation, rotation, and scale error over all organs are about 8 mm, 10 degrees and 0.03, and over all foot bones are about 3.5709 mm, 0.35 degrees and 0.025, respectively. The accuracy of delineation over all organs for all subjects as expressed in TPVF and FPVF is 93.01% and 0.22%, and all foot bones for all subjects are 93.75% and 0.28%, respectively. While the delineations for the four organs can be accomplished quite rapidly with average of 78 s, the delineations for the five foot bones can be accomplished with average of 70 s. The experimental results showed the feasibility and efficacy of the proposed automatic anatomy segmentation system: (a) the incorporation of shape priors into the GC framework is feasible in 3D as demonstrated previously for 2D images; (b) our results in 3D confirm the accuracy behavior observed in 2D. The hybrid strategy IGCASM seems to be more robust and accurate than ASM and GC individually; and (c) delineations within body regions and foot bones of clinical importance can be accomplished quite rapidly within 1.5 min.

A fully automatic, threshold-based segmentation method for the estimation of the Metabolic Tumor Volume from PET images: validation on 3D printed anthropomorphic oncological lesions

NASA Astrophysics Data System (ADS)

Gallivanone, F.; Interlenghi, M.; Canervari, C.; Castiglioni, I.

2016-01-01

18F-Fluorodeoxyglucose (18F-FDG) Positron Emission Tomography (PET) is a standard functional diagnostic technique to in vivo image cancer. Different quantitative paramters can be extracted from PET images and used as in vivo cancer biomarkers. Between PET biomarkers Metabolic Tumor Volume (MTV) has gained an important role in particular considering the development of patient-personalized radiotherapy treatment for non-homogeneous dose delivery. Different imaging processing methods have been developed to define MTV. The different proposed PET segmentation strategies were validated in ideal condition (e.g. in spherical objects with uniform radioactivity concentration), while the majority of cancer lesions doesn't fulfill these requirements. In this context, this work has a twofold objective: 1) to implement and optimize a fully automatic, threshold-based segmentation method for the estimation of MTV, feasible in clinical practice 2) to develop a strategy to obtain anthropomorphic phantoms, including non-spherical and non-uniform objects, miming realistic oncological patient conditions. The developed PET segmentation algorithm combines an automatic threshold-based algorithm for the definition of MTV and a k-means clustering algorithm for the estimation of the background. The method is based on parameters always available in clinical studies and was calibrated using NEMA IQ Phantom. Validation of the method was performed both in ideal (e.g. in spherical objects with uniform radioactivity concentration) and non-ideal (e.g. in non-spherical objects with a non-uniform radioactivity concentration) conditions. The strategy to obtain a phantom with synthetic realistic lesions (e.g. with irregular shape and a non-homogeneous uptake) consisted into the combined use of standard anthropomorphic phantoms commercially and irregular molds generated using 3D printer technology and filled with a radioactive chromatic alginate. The proposed segmentation algorithm was feasible in a clinical context and showed a good accuracy both in ideal and in realistic conditions.

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.

A generative model for segmentation of tumor and organs-at-risk for radiation therapy planning of glioblastoma patients

NASA Astrophysics Data System (ADS)

Agn, Mikael; Law, Ian; Munck af Rosenschöld, Per; Van Leemput, Koen

2016-03-01

We present a fully automated generative method for simultaneous brain tumor and organs-at-risk segmentation in multi-modal magnetic resonance images. The method combines an existing whole-brain segmentation technique with a spatial tumor prior, which uses convolutional restricted Boltzmann machines to model tumor shape. The method is not tuned to any specific imaging protocol and can simultaneously segment the gross tumor volume, peritumoral edema and healthy tissue structures relevant for radiotherapy planning. We validate the method on a manually delineated clinical data set of glioblastoma patients by comparing segmentations of gross tumor volume, brainstem and hippocampus. The preliminary results demonstrate the feasibility of the method.

A feasibility study of a psychoeducational intervention program for gynecological cancer patients.

PubMed

Chow, Ka Ming; Chan, Carmen W H; Chan, Joanne C Y; Choi, Kai K C; Siu, K Y

2014-08-01

This study aimed to test the feasibility of implementing a psychoeducational intervention program for gynecological cancer patients. A single-blinded randomized controlled trial and mixed-method design were used. Study subjects were newly diagnosed gynecological cancer patients with surgery as the first-line treatment. They were randomly assigned to the intervention group, in which a psychoeducational intervention program based on a thematic counseling model was offered, or to the attention control group. Quantitative data on sexual functioning, quality of life, uncertainty, anxiety, depression and social support were collected at recruitment, post-operative and during the in-hospital period, and eight weeks after the operation. Participants in the intervention group and three nurses working in the clinical setting were invited to have semi-structured interviews. Of the 30 eligible subjects, 26 were successfully recruited into the study. Following the psychoeducational intervention program, there was significant improvement in the level of inconsistent information about the illness within the category of uncertainty among participants in the intervention group. In addition, trends towards improvement were demonstrated in quality of life, uncertainty, depression and perceived social support with the provision of the interventions. Qualitative data indicated the interventions were desired and appreciated by the participants, as well as being feasible and practical to implement in Hong Kong clinical settings. The findings suggest that it is feasible to deliver the psychoeducational intervention program and it may have beneficial effects in gynecological cancer patients. A full-scale study is warranted to confirm the results. Copyright © 2014 Elsevier Ltd. All rights reserved.

FEASIBILITY AND SAFETY OF CONTRAST-ENHANCED ULTRASOUND IN THE DISTAL LIMB OF SIX HORSES.

PubMed

Seiler, Gabriela S; Campbell, Nigel; Nixon, Britton; Tsuruta, James K; Dayton, Paul A; Jennings, Samuel; Redding, W Rich; Lustgarten, Meghann

2016-05-01

Vascular alterations play important roles in many orthopedic diseases such as osteoarthritis, tendonitis, and synovitis in both human and equine athletes. Understanding these alterations could enhance diagnosis, prognosis, and treatment. Contrast-enhanced ultrasound (CEUS) could be a valuable method for evaluation of blood flow and perfusion of these processes in the equine distal limb, however no reports were found describing feasibility or safety of the technique. The goal of this prospective, experimental study was to describe the feasibility and safety of distal limb CEUS in a sample of six horses. For each horse, CEUS of the distal limb was performed after intravenous injections of 5 and 10 ml, as well as intra-arterial injections of 0.5 and 1 ml contrast medium. Vital parameters were monitored and CEUS images were assessed qualitatively and quantitatively for degree of contrast enhancement. None of the horses had clinically significant changes in their vital parameters after contrast medium injection. One horse had a transient increase in respiratory rate, and several horses had mild increases of systolic blood pressure of short duration after intravenous, but not after intra-arterial injections. Intra-arterial injection was possible in all horses and resulted in significantly improved contrast enhancement both quantitatively (P = 0.027) and qualitatively (P = 0.019). Findings from this study indicated that CEUS is a feasible and safe diagnostic test for evaluation of the equine distal limb. Future studies are needed to assess the clinical utility of this test for horses with musculoskeletal diseases. © 2016 American College of Veterinary Radiology.

Application of best practice guidelines for OSCEs-An Australian evaluation of their feasibility and value.

PubMed

Mitchell, Marion L; Henderson, Amanda; Jeffrey, Carol; Nulty, Duncan; Groves, Michele; Kelly, Michelle; Knight, Sabina; Glover, Pauline

2015-05-01

Objective Structured Clinical Examinations (OSCEs) are widely used in health professional education and should be based on sound pedagogical foundations. The aim of this study is to evaluate the feasibility and utility of using Best Practice Guidelines (BPGs) within an OSCE format in a broad range of tertiary education settings with under-graduate and post-graduate nursing and midwifery students. We evaluated how feasible it was to apply the BPGs to modify OSCEs in a course; students' perspective of the OSCE; and finally, if the BPG-revised OSCEs better prepared students for clinical practice when compared with the original OSCEs. A mixed method with surveys, focus groups and semi-structured interviews evaluated the BPGs within an OSCE. Four maximally different contexts across four sites in Australia were used. Participants included lecturers and undergraduate nursing students in high and low fidelity simulation settings; under-graduate midwifery students; and post-graduate rural and remote area nursing students. 691 students participated in revised OSCEs. Surveys were completed by 557 students; 91 students gave further feedback through focus groups and 14 lecturers participated in interviews. At all sites the BPGs were successfully used to modify and implement OSCEs. Students valued the realistic nature of the modified OSCEs which contributed to students' confidence and preparation for clinical practice. The lecturers considered the revised OSCEs enhanced student preparedness for their clinical placements. The BPGs have a broad applicability to OSCEs in a wide range of educational contexts with improved student outcomes. Students and lecturers identified the revised OSCEs enhanced student preparation for clinical practice. Subsequent examination of the BPGs saw further refinement to a set of eight BPGs that provide a sequential guide to their application in a way that is consistent with best practice curriculum design principles. Copyright © 2015 Elsevier Ltd. All rights reserved.

Optical diagnosis of testicular torsion: feasibility and methodology

NASA Astrophysics Data System (ADS)

Shadgan, Babak; Macnab, Andrew; Stothers, Lynn; Kajbafzadeh, A. M.

2014-03-01

Background: Torsion of the testis compromises blood flow through the spermatic cord; testicular ischemia results which if not diagnosed promptly and corrected surgically irrevocably damages the testis. Current diagnostic modalities aimed at rationalizing surgical exploration by demonstrating interruption of spermatic cord blood flow or testicular ischemia have limited applicability. Near infrared spectroscopy (NIRS) offers a non-invasive optical method for detection of ischemia; continuous wave and frequency domain devices have been used experimentally; no device customized for clinical use has been designed. Methods: A miniature spatially resolved NIRS device with light emitting diode light source was applied over the right and left spermatic cord and the difference in oxygen saturation between the two sides measured. Results: In a 14-month old boy with a history of unilateral testicular pain color Doppler ultrasonography was equivocal but the NIRS-derived tissue oxygen saturation index (TSI) was significantly reduced on the left side. Confirmation of torsion of the left testicle was made surgically. Conclusions: Spatially resolved NIRS monitoring of spermatic cord oxygen saturation is feasible in children, adding to prior studies of testicular oxygen saturation in adults. Customized device design and further clinical trials would enhance the applicability of NIRS as a diagnostic entity for torsion.

Spatial modeling and classification of corneal shape.

PubMed

Marsolo, Keith; Twa, Michael; Bullimore, Mark A; Parthasarathy, Srinivasan

2007-03-01

One of the most promising applications of data mining is in biomedical data used in patient diagnosis. Any method of data analysis intended to support the clinical decision-making process should meet several criteria: it should capture clinically relevant features, be computationally feasible, and provide easily interpretable results. In an initial study, we examined the feasibility of using Zernike polynomials to represent biomedical instrument data in conjunction with a decision tree classifier to distinguish between the diseased and non-diseased eyes. Here, we provide a comprehensive follow-up to that work, examining a second representation, pseudo-Zernike polynomials, to determine whether they provide any increase in classification accuracy. We compare the fidelity of both methods using residual root-mean-square (rms) error and evaluate accuracy using several classifiers: neural networks, C4.5 decision trees, Voting Feature Intervals, and Naïve Bayes. We also examine the effect of several meta-learning strategies: boosting, bagging, and Random Forests (RFs). We present results comparing accuracy as it relates to dataset and transformation resolution over a larger, more challenging, multi-class dataset. They show that classification accuracy is similar for both data transformations, but differs by classifier. We find that the Zernike polynomials provide better feature representation than the pseudo-Zernikes and that the decision trees yield the best balance of classification accuracy and interpretability.

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

PubMed Central

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

2018-01-01

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

Precision and accuracy of clinical quantification of myocardial blood flow by dynamic PET: A technical perspective.

PubMed

Moody, Jonathan B; Lee, Benjamin C; Corbett, James R; Ficaro, Edward P; Murthy, Venkatesh L

2015-10-01

A number of exciting advances in PET/CT technology and improvements in methodology have recently converged to enhance the feasibility of routine clinical quantification of myocardial blood flow and flow reserve. Recent promising clinical results are pointing toward an important role for myocardial blood flow in the care of patients. Absolute blood flow quantification can be a powerful clinical tool, but its utility will depend on maintaining precision and accuracy in the face of numerous potential sources of methodological errors. Here we review recent data and highlight the impact of PET instrumentation, image reconstruction, and quantification methods, and we emphasize (82)Rb cardiac PET which currently has the widest clinical application. It will be apparent that more data are needed, particularly in relation to newer PET technologies, as well as clinical standardization of PET protocols and methods. We provide recommendations for the methodological factors considered here. At present, myocardial flow reserve appears to be remarkably robust to various methodological errors; however, with greater attention to and more detailed understanding of these sources of error, the clinical benefits of stress-only blood flow measurement may eventually be more fully realized.

Shifting attention from objective risk factors to patients' self-assessed health resources: a clinical model for general practice.

PubMed

Hollnagel, H; Malterud, K

1995-12-01

The study was designed to present and apply theoretical and empirical knowledge for the construction of a clinical model intended to shift the attention of the general practitioner from objective risk factors to self-assessed health resources in male and female patients. Review, discussion and analysis of selected theoretical models about personal health resources involving assessing existing theories according to their emphasis concerning self-assessed vs. doctor-assessed health resources, specific health resources vs. life and coping in general, abstract vs. clinically applicable theory, gender perspective explicitly included or not. Relevant theoretical models on health and coping (salutogenesis, coping and social support, control/demand, locus of control, health belief model, quality of life), and the perspective of the underprivileged Other (critical theory, feminist standpoint theory, the patient-centred clinical method) were presented and assessed. Components from Antonovsky's salutogenetic perspective and McWhinney's patient-centred clinical method, supported by gender perspectives, were integrated to a clinical model which is presented. General practitioners are recommended to shift their attention from objective risk factors to self-assessed health resources by means of the clinical model. The relevance and feasibility of the model should be explored in empirical research.

Feasibility study of the BrightBrainer™ integrative cognitive rehabilitation system for elderly with dementia

PubMed Central

Burdea, Grigore; Polistico, Kevin; Krishnamoorthy, Amalan; House, Gregory; Rethage, Dario; Hundal, Jasdeep; Damiani, Frank; Pollack, Simcha

2014-01-01

Purpose To describe the development of BrightBrainer™ integrative cognitive rehabilitation system and determine clinical feasibility with nursing home-bound dementia patients. Method BrightBrainer cognitive rehabilitation simulations were first played uni-manually, then bimanually. Participants sat in front of a laptop and interacted through a game controller that measured hand movements in 3D, as well as flexion of both index fingers. Interactive serious games were designed to improve basic and complex attention (concentration, short-term memory, dual tasking), memory recall, executive functioning and emotional well-being. Individual simulations adapted automatically to each participant's level of motor functioning. The system underwent feasibility trials spanning 16 sessions over 8 weeks. Participants were evaluated pre- and post-intervention, using standardized neuropsychological measures. Computerized measures of movement repetitions and task performance were stored on a remote server. Results Group analysis for 10 participants showed statistically significant improvement in decision making (p<0.01), with trend improvements in depression (p<0.056). Improvements were also seen in processing speed (p<0.13) and auditory attention (p<0.17); however, these were not statistically significant (partly attributable to the modest sample size). Eight of nine neuropsychological tests showed changes in the improvement direction indicating an effective rehabilitation (p<0.01). BrightBrainer technology was well tolerated with mean satisfaction ratings of 4.9/5.0 across participants. Conclusions Preliminary findings demonstrate utility within an advanced dementia population, suggesting that it will be beneficial to evaluate BrightBrainer through controlled clinical trials and to investigate its application in other clinical populations. PMID:24679074

Clinical Trials Targeting Aging and Age-Related Multimorbidity

PubMed Central

Crimmins, Eileen M; Grossardt, Brandon R; Crandall, Jill P; Gelfond, Jonathan A L; Harris, Tamara B; Kritchevsky, Stephen B; Manson, JoAnn E; Robinson, Jennifer G; Rocca, Walter A; Temprosa, Marinella; Thomas, Fridtjof; Wallace, Robert; Barzilai, Nir

2017-01-01

Abstract Background There is growing interest in identifying interventions that may increase health span by targeting biological processes underlying aging. The design of efficient and rigorous clinical trials to assess these interventions requires careful consideration of eligibility criteria, outcomes, sample size, and monitoring plans. Methods Experienced geriatrics researchers and clinical trialists collaborated to provide advice on clinical trial design. Results Outcomes based on the accumulation and incidence of age-related chronic diseases are attractive for clinical trials targeting aging. Accumulation and incidence rates of multimorbidity outcomes were developed by selecting at-risk subsets of individuals from three large cohort studies of older individuals. These provide representative benchmark data for decisions on eligibility, duration, and assessment protocols. Monitoring rules should be sensitive to targeting aging-related, rather than disease-specific, outcomes. Conclusions Clinical trials targeting aging are feasible, but require careful design consideration and monitoring rules. PMID:28364543

Is the common cold a clinical entity or a cultural concept?

PubMed

Eccles, R

2013-03-01

Common cold is the most common infectious disease of mankind and the term is widely used in the clinical literature as though it were a defined clinical syndrome. Clinical studies on this syndrome often use elaborate symptom scoring systems to diagnose a common cold. The symptom scores are based on a study conducted over 50 years ago to retrospectively diagnose experimental cold and this method cannot be applied to diagnosis of common cold in the community. Diagnosis of the common cold by virology is not feasible because of the number of viruses and the variability in the disease states caused by the viruses. Because of the familiarity of subjects with common cold and the variability in symptomatology it seems a more reasonable approach to use self-diagnosis of common cold for clinical research studies and accept that the common cold is a cultural concept and not a clinical entity.

Pre-clinical research in small animals using radiotherapy technology--a bidirectional translational approach.

PubMed

Tillner, Falk; Thute, Prasad; Bütof, Rebecca; Krause, Mechthild; Enghardt, Wolfgang

2014-12-01

For translational cancer research, pre-clinical in-vivo studies using small animals have become indispensable in bridging the gap between in-vitro cell experiments and clinical implementation. When setting up such small animal experiments, various biological, technical and methodical aspects have to be considered. In this work we present a comprehensive topical review based on relevant publications on irradiation techniques used for pre-clinical cancer research in mice and rats. Clinical radiotherapy treatment devices for the application of external beam radiotherapy and brachytherapy as well as dedicated research irradiation devices are feasible for small animal irradiation depending on the animal model and the experimental goals. In this work, appropriate solutions for the technological transfer of human radiation oncology to small animal radiation research are summarised. Additionally, important information concerning the experimental design is provided such that reliable and clinically relevant results can be attained. Copyright © 2014. Published by Elsevier GmbH.

Applying the trigger review method after a brief educational intervention: potential for teaching and improving safety in GP specialty training?

PubMed Central

2013-01-01

Background The Trigger Review Method (TRM) is a structured approach to screening clinical records for undetected patient safety incidents (PSIs) and identifying learning and improvement opportunities. In Scotland, TRM participation can inform GP appraisal and has been included as a core component of the national primary care patient safety programme that was launched in March 2013. However, the clinical workforce needs up-skilled and the potential of TRM in GP training has yet to be tested. Current TRM training utilizes a workplace face-to-face session by a GP expert, which is not feasible. A less costly, more sustainable educational intervention is necessary to build capability at scale. We aimed to determine the feasibility and impact of TRM and a related training intervention in GP training. Methods We recruited 25 west of Scotland GP trainees to attend a 2-hour TRM workshop. Trainees then applied TRM to 25 clinical records and returned findings within 4-weeks. A follow-up feedback workshop was held. Results 21/25 trainees (84%) completed the task. 520 records yielded 80 undetected PSIs (15.4%). 36/80 were judged potentially preventable (45%) with 35/80 classified as causing moderate to severe harm (44%). Trainees described a range of potential learning and improvement plans. Training was positively received and appeared to be successful given these findings. TRM was valued as a safety improvement tool by most participants. Conclusion This small study provides further evidence of TRM utility and how to teach it pragmatically. TRM is of potential value in GP patient safety curriculum delivery and preparing trainees for future safety improvement expectations. PMID:24000946

Efficacy, Safety, and Feasibility of the Morphine Microdose Method in Community-Based Clinics.

PubMed

Wilkes, Denise M; Orillosa, Susan J; Hustak, Erik C; Williams, Courtney G; Doulatram, Gulshan R; Solanki, Daneshvari R; Garcia, Eduardo A; Huang, Li-Yen M

2017-06-13

The goal of this study was to assess the success of the morphine microdose method in a community pain clinic setting by monitoring follow-up frequency, dose escalation, and monotherapy/polytherapy ratio. The morphine microdose method involves a pretrial reduction or elimination of systemic opioids followed by a period of abstinence. Intrathecal (IT) morphine is then started at doses of less than 0.2 mg per day. Systemic opioid abstinence is then continued after pump implant and IT morphine monotherapy. Retrospective review of medical records. Private and academic pain clinic practices. Chronic noncancer pain patients. We reviewed the charts of 60 patients who had completed a microdose regimen and had an IT pump implanted between June 11, 2008, and October 11, 2014. During IT therapy, dose change over time, pain scores, side effects, max dose, and duration were recorded. The majority of patients (35/60, 58%) were successfully managed solely on morphine microdose monotherapy. These patients did not require additional oral therapy. There was a significant reduction in mean pain scores, from 7.4 ± 0.32 before microdose therapy to 4.8 ± 0.3 after microdose therapy. Microdose therapy achieved analgesia, improved safety, and avoided systemic side effects. The safety of IT therapy was increased by using a lower concentration (2 mg/mL) and lower daily doses (<3 mg/d) of morphine. Furthermore, microdose therapy was feasible, safe, and cost-effective in the outpatient setting. 2017 American Academy of Pain Medicine. This work is written by US Government employees and is in the public domain in the US.

A general method to determine sampling windows for nonlinear mixed effects models with an application to population pharmacokinetic studies.

PubMed

Foo, Lee Kien; McGree, James; Duffull, Stephen

2012-01-01

Optimal design methods have been proposed to determine the best sampling times when sparse blood sampling is required in clinical pharmacokinetic studies. However, the optimal blood sampling time points may not be feasible in clinical practice. Sampling windows, a time interval for blood sample collection, have been proposed to provide flexibility in blood sampling times while preserving efficient parameter estimation. Because of the complexity of the population pharmacokinetic models, which are generally nonlinear mixed effects models, there is no analytical solution available to determine sampling windows. We propose a method for determination of sampling windows based on MCMC sampling techniques. The proposed method attains a stationary distribution rapidly and provides time-sensitive windows around the optimal design points. The proposed method is applicable to determine sampling windows for any nonlinear mixed effects model although our work focuses on an application to population pharmacokinetic models. Copyright © 2012 John Wiley & Sons, Ltd.

Physiological and Performance Measures for Baseline Concussion Assessment.

PubMed

Dobney, Danielle M; Thomas, Scott G; Taha, Tim; Keightley, Michelle

2017-05-17

Baseline testing is a common strategy for concussion assessment and management. Research continues to evaluate novel measures for potential to improve baseline testing methods. The primary objective was to; 1) determine the feasibility of including physiological, neuromuscular and mood measures as part of baseline concussion testing protocol, 2) describe typical values in a varsity athlete sample, and 3) estimate the influence of concussion history on these baseline measures. Prospective observational study. University Athletic Therapy Clinic. 100 varsity athletes. Frequency and domain measures of heart rate variability (HRV), blood pressure (BP), grip strength, Profile of Mood States and the Sport Concussion Assessment Tool-2. Physiological, neuromuscular performance and mood measures were feasible at baseline. Participants with a history of two or more previous concussions displayed significantly higher diastolic blood pressure. Females reported higher total mood disturbance compared to males. Physiological and neuromuscular performance measures are safe and feasible as baseline concussion assessment outcomes. History of concussion may have an influence on diastolic blood pressure.

Acceptability and Feasibility of HIV Self-Testing Among Transgender Women in San Francisco: A Mixed Methods Pilot Study.

PubMed

Lippman, Sheri A; Moran, Lissa; Sevelius, Jae; Castillo, Leslie S; Ventura, Angel; Treves-Kagan, Sarah; Buchbinder, Susan

2016-04-01

An estimated one in four transgender women (trans women) in the U.S. are infected with HIV. Rates of HIV testing are not commensurate with their risk, necessitating alternative strategies for early detection and care. We explored the feasibility and acceptability of HIV self-testing (HIVST) with 50 HIV-negative adult trans women in San Francisco. Participants received three self-test kits to perform once a month. Acceptability and behavioral surveys were collected as were 11 in-depth interviews (IDIs). Among 50 participants, 44 reported utilizing HIVST at least once; 94 % reported the test easy to use; 93 % said results were easy to read; and 91 % would recommend it to others. Most participants (68 %) preferred HIVST to clinic-based testing, although price was a key barrier to uptake. IDIs revealed a tension between desires for privacy versus support found at testing sites. HIVST for trans women was acceptable and feasible and requires careful consideration of linkage to support services.

Feasibility and effectiveness of the implementation of a primary prevention programme for type 2 diabetes in routine primary care practice: a phase IV cluster randomised clinical trial

PubMed Central

2012-01-01

Background The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. Methods/design This is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation. Discussion The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice. Trial registration ClinicalTrials.gov NCT01365013 PMID:23158830

Vital Signs Screening for Alcohol Misuse in a Rural Primary Care Clinic: A Feasibility Study

ERIC Educational Resources Information Center

Seale, J. Paul; Guyinn, Monique R.; Matthews, Michael; Okosun, Ike; Dent, M. Marie

2008-01-01

Context: Alcohol misuse is more common in rural areas, and rural problem drinkers are less likely to seek alcohol treatment services. Rural clinics face unique challenges to implementing routine alcohol screening and intervention. Purpose: To assess the feasibility of using the single alcohol screening question (SASQ) during routine nursing vital…

Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study

PubMed Central

Latham, Nancy K; Quintiliani, Lisa M

2018-01-01

Background Long-term engagement in exercise and physical activity mitigates the progression of disability and increases quality of life in people with Parkinson disease (PD). Despite this, the vast majority of individuals with PD are sedentary. There is a critical need for a feasible, safe, acceptable, and effective method to assist those with PD to engage in active lifestyles. Peer coaching through mobile health (mHealth) may be a viable approach. Objective The purpose of this study was to develop a PD-specific peer coach training program and a remote peer-mentored walking program using mHealth technology with the goal of increasing physical activity in persons with PD. We set out to examine the feasibility, safety, and acceptability of the programs along with preliminary evidence of individual-level changes in walking activity, self-efficacy, and disability in the peer mentees. Methods A peer coach training program and a remote peer-mentored walking program using mHealth was developed and tested in 10 individuals with PD. We matched physically active persons with PD (peer coaches) with sedentary persons with PD (peer mentees), resulting in 5 dyads. Using both Web-based and in-person delivery methods, we trained the peer coaches in basic knowledge of PD, exercise, active listening, and motivational interviewing. Peer coaches and mentees wore FitBit Zip activity trackers and participated in daily walking over 8 weeks. Peer dyads interacted daily via the FitBit friends mobile app and weekly via telephone calls. Feasibility was determined by examining recruitment, participation, and retention rates. Safety was assessed by monitoring adverse events during the study period. Acceptability was assessed via satisfaction surveys. Individual-level changes in physical activity were examined relative to clinically important differences. Results Four out of the 5 peer pairs used the FitBit activity tracker and friends function without difficulty. A total of 4 of the 5 pairs completed the 8 weekly phone conversations. There were no adverse events over the course of the study. All peer coaches were “satisfied” or “very satisfied” with the training program, and all participants were “satisfied” or “very satisfied” with the peer-mentored walking program. All participants would recommend this program to others with PD. Increases in average steps per day exceeding the clinically important difference occurred in 4 out of the 5 mentees. Conclusions Remote peer coaching using mHealth is feasible, safe, and acceptable for persons with PD. Peer coaching using mHealth technology may be a viable method to increase physical activity in individuals with PD. Larger controlled trials are necessary to examine the effectiveness of this approach. PMID:29449201

THE 6-MINUTE WALK TEST AND OTHER CLINICAL ENDPOINTS IN DUCHENNE MUSCULAR DYSTROPHY: RELIABILITY, CONCURRENT VALIDITY, AND MINIMAL CLINICALLY IMPORTANT DIFFERENCES FROM A MULTICENTER STUDY

PubMed Central

McDonald, Craig M; Henricson, Erik K; Abresch, R Ted; Florence, Julaine; Eagle, Michelle; Gappmaier, Eduard; Glanzman, Allan M; Spiegel, Robert; Barth, Jay; Elfring, Gary; Reha, Allen; Peltz, Stuart W

2013-01-01

Introduction: An international clinical trial enrolled 174 ambulatory males ≥5 years old with nonsense mutation Duchenne muscular dystrophy (nmDMD). Pretreatment data provide insight into reliability, concurrent validity, and minimal clinically important differences (MCIDs) of the 6-minute walk test (6MWT) and other endpoints. Methods: Screening and baseline evaluations included the 6-minute walk distance (6MWD), timed function tests (TFTs), quantitative strength by myometry, the PedsQL, heart rate–determined energy expenditure index, and other exploratory endpoints. Results: The 6MWT proved feasible and reliable in a multicenter context. Concurrent validity with other endpoints was excellent. The MCID for 6MWD was 28.5 and 31.7 meters based on 2 statistical distribution methods. Conclusions: The ratio of MCID to baseline mean is lower for 6MWD than for other endpoints. The 6MWD is an optimal primary endpoint for Duchenne muscular dystrophy (DMD) clinical trials that are focused therapeutically on preservation of ambulation and slowing of disease progression. Muscle Nerve 48: 357–368, 2013 PMID:23674289

Feasibility of using a large Clinical Data Warehouse to automate the selection of diagnostic cohorts.

PubMed

Stephen, Reejis; Boxwala, Aziz; Gertman, Paul

2003-01-01

Data from Clinical Data Warehouses (CDWs) can be used for retrospective studies and for benchmarking. However, automated identification of cases from large datasets containing data items in free text fields is challenging. We developed an algorithm for categorizing pediatric patients presenting with respiratory distress into Bronchiolitis, Bacterial pneumonia and Asthma using clinical variables from a CDW. A feasibility study of this approach indicates that case selection may be automated.

Do digital innovations for HIV and sexually transmitted infections work? Results from a systematic review (1996-2017)

PubMed Central

Daher, Jana; Vijh, Rohit; Linthwaite, Blake; Dave, Sailly; Kim, John; Dheda, Keertan; Peter, Trevor; Pai, Nitika Pant

2017-01-01

Objective Digital innovations with internet/mobile phones offer a potential cost-saving solution for overburdened health systems with high service delivery costs to improve efficiency of HIV/STI (sexually transmitted infections) control initiatives. However, their overall evidence has not yet been appraised. We evaluated the feasibility and impact of all digital innovations for all HIV/STIs. Design Systematic review. Setting/participants All settings/all participants. Intervention We classified digital innovations into (1) mobile health-based (mHealth: SMS (short message service)/phone calls), (2) internet-based mobile and/or electronic health (mHealth/eHealth: social media, avatar-guided computer programs, websites, mobile applications, streamed soap opera videos) and (3) combined innovations (included both SMS/phone calls and internet-based mHealth/eHealth). Primary and secondary outcome measures Feasibility, acceptability, impact. Methods We searched databases MEDLINE via PubMed, Embase, Cochrane CENTRAL and Web of Science, abstracted data, explored heterogeneity, performed a random effects subgroup analysis. Results We reviewed 99 studies, 63 (64%) were from America/Europe, 36 (36%) from Africa/Asia; 79% (79/99) were clinical trials; 84% (83/99) evaluated impact. Of innovations, mHealth based: 70% (69/99); internet based: 21% (21/99); combined: 9% (9/99). All digital innovations were highly accepted (26/31; 84%), and feasible (20/31; 65%). Regarding impacted measures, mHealth-based innovations (SMS) significantly improved antiretroviral therapy (ART) adherence (pooled OR=2.15(95%CI: 1.18 to 3.91)) and clinic attendance rates (pooled OR=1.76(95%CI: 1.28, 2.42)); internet-based innovations improved clinic attendance (6/6), ART adherence (4/4), self-care (1/1), while reducing risk (5/5); combined innovations increased clinic attendance, ART adherence, partner notifications and self-care. Confounding (68%) and selection bias (66%) were observed in observational studies and attrition bias in 31% of clinical trials. Conclusion Digital innovations were acceptable, feasible and generated impact. A trend towards the use of internet-based and combined (internet and mobile) innovations was noted. Large scale-up studies of high quality, with new integrated impact metrics, and cost-effectiveness are needed. Findings will appeal to all stakeholders in the HIV/STI global initiatives space. PMID:29101138

Development of the adult PedsQL™ neurofibromatosis type 1 module: initial feasibility, reliability and validity.

PubMed

Nutakki, Kavitha; Hingtgen, Cynthia M; Monahan, Patrick; Varni, James W; Swigonski, Nancy L

2013-02-21

Neurofibromatosis type 1 (NF1) is a common autosomal dominant genetic disorder with significant impact on health-related quality of life (HRQOL). Research in understanding the pathogenetic mechanisms of neurofibroma development has led to the use of new clinical trials for the treatment of NF1. One of the most important outcomes of a trial is improvement in quality of life, however, no condition specific HRQOL instrument for NF1 exists. The objective of this study was to develop an NF1 HRQOL instrument as a module of PedsQL™ and to test for its initial feasibility, internal consistency reliability and validity in adults with NF1. The NF1 specific HRQOL instrument was developed using a standard method of PedsQL™ module development - literature review, focus group/semi-structured interviews, cognitive interviews and experts' review of initial draft, pilot testing and field testing. Field testing involved 134 adults with NF1. Feasibility was measured by the percentage of missing responses, internal consistency reliability was measured with Cronbach's alpha and validity was measured by the known-groups method. Feasibility, measured by the percentage of missing responses was 4.8% for all subscales on the adult version of the NF1-specific instrument. Internal consistency reliability for the Total Score (alpha =0.97) and subscale reliabilities ranging from 0.72 to 0.96 were acceptable for group comparisons. The PedsQL™ NF1 module distinguished between NF1 adults with excellent to very good, good, and fair to poor health status. The results demonstrate the initial feasibility, reliability and validity of the PedsQL™ NF1 module in adult patients. The PedsQL™ NF1 Module can be used to understand the multidimensional nature of NF1 on the HRQOL patients with this disorder.

Culturally adaptive storytelling method to improve hypertension control in Vietnam - "We talk about our hypertension": study protocol for a feasibility cluster-randomized controlled trial.

PubMed

Allison, Jeroan J; Nguyen, Hoa L; Ha, Duc A; Chiriboga, Germán; Ly, Ha N; Tran, Hanh T; Phan, Ngoc T; Vu, Nguyen C; Kim, Minjin; Goldberg, Robert J

2016-01-14

Vietnam is experiencing an epidemiologic transition with an increased prevalence of non-communicable diseases. At present, the major risk factors for cardiovascular disease (CVD) are either on the rise or at alarming levels in Vietnam; inasmuch, the burden of CVD will continue to increase in this country unless effective prevention and control measures are put in place. A national survey in 2008 found that the prevalence of hypertension (HTN) was approximately 25 % among Vietnamese adults and it increased with advancing age. Therefore, novel, large-scale, and sustainable interventions for public health education to promote engagement in the process of detecting and treating HTN in Vietnam are urgently needed. A feasibility randomized trial will be conducted in Hung Yen province, Vietnam to evaluate the feasibility and acceptability of a novel community-based intervention using the "storytelling" method to enhance the control of HTN in adults residing in four rural communities. The intervention will center on stories about living with HTN, with patients speaking in their own words. The stories will be obtained from particularly eloquent patients, or "video stars," identified during Story Development Groups. The study will involve two phases: (i) developing a HTN intervention using the storytelling method, which is designed to empower patients to facilitate changes in their lifestyle practices, and (ii) conducting a feasibility cluster-randomized trial to investigate the feasibility, acceptability, and potential efficacy of the intervention compared with usual care in HTN control among rural residents. The trial will be conducted at four communes, and within each commune, 25 individuals 50 years or older with HTN will be enrolled in the trial resulting in a total sample size of 100 patients. This feasibility trial will provide the necessary groundwork for a subsequent large-scale, fully powered, cluster-randomized controlled trial to test the efficacy of our novel community-based intervention. Results from the full-scale trial will provide health policy makers with practical evidence on how to combat a key risk factor for CVD using a feasible, sustainable, and cost-effective intervention that could be used as a national program for controlling HTN in Vietnam and other developing countries. ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02483780 (registration date June 22, 2015).

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.

TU-H-BRC-08: Use and Validation of Flexible 3D Printed Tissue Compensators for Post-Mastectomy Radiation Therapy

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

Craft, D; Kry, S; Salehpour, M

Purpose: Patient-specific tissue equivalent compensators can be used for post-mastectomy radiation therapy (PMRT) to achieve homogenous dose distributions with single-field treatments. However, current fabrication methods are time consuming and expensive. 3D-printing technology could overcome these limitations. The purposes of this study were to [1] evaluate materials for 3D-printed compensators [2] design and print a compensator to achieve a uniform thickness to a clinical target volume (CTV), and [3] demonstrate that a single-field electron compensator plan is a clinically feasible treatment option for PMRT. Methods: Blocks were printed with three materials; print accuracy, density, Hounsfield units (HU), and percent depth dosesmore » (PDD) were evaluated. For a CT scan of an anthropomorphic phantom, we used a ray-tracing method to design a compensator that achieved uniform thickness from compensator surface to CTV. The compensator was printed with flexible tissue equivalent material whose physical and radiological properties were most similar to soft tissue. A single-field electron compensator plan was designed and compared with two standard-of-care techniques. The compensator plan was validated with thermoluminescent dosimeter (TLD) measurements. Results: We identified an appropriate material for 3D-printed compensators that had high print accuracy (99.6%) and was similar to soft tissue; density was 1.04, HU was - 45 ± 43, and PDD curves agreed with clinical curves within 3 mm. We designed and printed a compensator that conformed well to the phantom surface and created a uniform thickness to the CTV. In-house fabrication was simple and inexpensive (<$75). Compared with the two standard plans, the compensator plan resulted in overall more homogeneous dose distributions and performed similarly in terms of lung/heart doses and 90% isodose coverage of the CTV. TLD measurements agreed well with planned doses (within 5 %). Conclusions: We have demonstrated that 3D-printed compensators make single-field electron therapy a clinically feasible treatment option for PMRT.« less

Clinical feasibility study of combined opto-acoustic and ultrasonic imaging modality providing coregistered functional and anatomical maps of breast tumors

NASA Astrophysics Data System (ADS)

Zalev, Jason; Clingman, Bryan; Smith, Remie J.; Herzog, Don; Miller, Tom; Stavros, A. Thomas; Ermilov, Sergey; Conjusteau, André; Tsyboulski, Dmitri; Oraevsky, Alexander A.; Kist, Kenneth; Dornbluth, N. C.; Otto, Pamela

2013-03-01

We report on findings from the clinical feasibility study of the ImagioTM. Breast Imaging System, which acquires two-dimensional opto-acoustic (OA) images co-registered with conventional ultrasound using a specialized duplex hand-held probe. Dual-wavelength opto-acoustic technology is used to generate parametric maps based upon total hemoglobin and its oxygen saturation in breast tissues. This may provide functional diagnostic information pertaining to tumor metabolism and microvasculature, which is complementary to morphological information obtained with conventional gray-scale ultrasound. We present co-registered opto-acoustic and ultrasonic images of malignant and benign tumors from a recent clinical feasibility study. The clinical results illustrate that the technology may have the capability to improve the efficacy of breast tumor diagnosis. In doing so, it may have the potential to reduce biopsies and to characterize cancers that were not seen well with conventional gray-scale ultrasound alone.

Improving Adolescent Health Risk Assessment: A Multi-method Pilot Study.

PubMed

Thompson, Lindsay A; Wegman, Martin; Muller, Keith; Eddleton, Katie Z; Muszynski, Michael; Rathore, Mobeen; De Leon, Jessica; Shenkman, Elizabeth A

2016-12-01

Objectives Given poor compliance by providers with adolescent health risk assessment (HRA) in primary care, we describe the development and feasibility of using a health information technology (HIT)-enhanced HRA to improve the frequency of HRAs in diverse clinical settings, asking adolescents' recall of quality of care as a primary outcome. Methods We conducted focus groups and surveys with key stakeholders (Phase I) , including adolescents, clinic staff and providers to design and implement an intervention in a practice-based research network delivering private, comprehensive HRAs via tablet (Phase II). Providers and adolescents received geo-coded community resources according to individualized risks. Following the point-of-care implementation , we collected patient-reported outcomes using post-visit quality surveys (Phase III). Patient-reported outcomes from intervention and comparison clinics were analyzed using a mixed-model, fitted separately for each survey domain. Results Stakeholders agreed upon an HIT-enhanced HRA (Phase I). Twenty-two academic and community practices in north-central Florida then recruited 609 diverse adolescents (14-18 years) during primary care visits over 6 months; (mean patients enrolled = 28; median = 20; range 1-116; Phase II). Adolescents receiving the intervention later reported higher receipt of confidential/private care and counseling related to emotions and relationships (adjusted scores 0.42 vs 0.08 out of 1.0, p < .01; 0.85 vs 0.57, p < .001, respectively, Phase III) than those receiving usual care. Both are important quality indicators for adolescent well-child visits. Conclusions Stakeholder input was critical to the acceptability of the HIT-enhanced HRA. Patient recruitment data indicate that the intervention was feasible in a variety of clinical settings and the pilot evaluation data indicate that the intervention may improve adolescents' perceptions of high quality care.

Comparison of droplet digital PCR and conventional quantitative PCR for measuring EGFR gene mutation

PubMed Central

ZHANG, BO; XU, CHUN-WEI; SHAO, YUN; WANG, HUAI-TAO; WU, YONG-FANG; SONG, YE-YING; LI, XIAO-BING; ZHANG, ZHE; WANG, WEN-JING; LI, LI-QIONG; CAI, CONG-LI

2015-01-01

Early detection of epidermal growth factor receptor (EGFR) mutation, particularly EGFR T790M mutation, is of clinical significance. The aim of the present study was to compare the performances of amplification refractory mutation system-based quantitative polymerase chain reaction (ARMS-qPCR) and droplet digital polymerase chain reaction (ddPCR) approaches in the detection of EGFR mutation and explore the feasibility of using ddPCR in the detection of samples with low mutation rates. EGFR gene mutations in plasmid samples with different T790M mutation rates (0.1–5%) and 10 clinical samples were detected using the ARMS-qPCR and ddPCR approaches. The results demonstrated that the ARMS-qPCR method stably detected the plasmid samples (6,000 copies) with 5 and 1% mutation rates, while the ddPCR approach reliably detected those with 5% (398 copies), 1% (57 copies), 0.5% (24 copies) and 0.1% (average 6 copies) mutation rates. For the 10 clinical samples, the results for nine samples by the ARMS-qPCR and ddPCR methods were consistent; however, the sample N006, indicated to be EGFR wild-type by ARMS-qPCR, was revealed to have a clear EGFR T790M mutation with seven copies of mutant alleles in a background of 6,000 wild-type copies using ddPCR technology. This study demonstrates the feasibility of applying the ddPCR system to detect EGFR mutation and identified the advantage of ddPCR in the detection of samples with a low EGFR mutation abundance, particularly the secondary EGFR T790M resistance mutation, which enables early diagnosis before acquired resistance to tyrosine kinase inhibitors becomes clinically detectable. PMID:25780439

Feasibility of Economic Analysis of Radiation Therapy Oncology Group (RTOG) 91-11 Using Medicare Data

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

Konski, Andre, E-mail: akonski@med.wayne.ed; Bhargavan, Mythreyi; Owen, Jean

Purpose: The specific aim of this analysis was to evaluate the feasibility of performing a cost-effectiveness analysis using Medicare data from patients treated on a randomized Phase III clinical trial. Methods and Materials: Cost data included Medicare Part A and Part B costs from all providers-inpatient, outpatient, skilled nursing facility, home health, hospice, and physicians-and were obtained from the Centers for Medicare and Medicaid Services for patients eligible for Medicare, treated on Radiation Therapy Oncology Group (RTOG) 9111 between 1992 and 1996. The 47-month expected discounted (annual discount rate of 3%) cost for each arm of the trial was calculatedmore » in 1996 dollars, with Kaplan-Meier sampling average estimates of survival probabilities for each month and mean monthly costs. Overall and disease-free survival was also discounted 3%/year. The analysis was performed from a payer's perspective. Incremental cost-effectiveness ratios were calculated comparing the chemotherapy arms to the radiation alone arm. Results: Of the 547 patients entered, Medicare cost data and clinical outcomes were available for 66 patients. Reasons for exclusion included no RTOG follow-up, Medicare HMO enrollment, no Medicare claims since trial entry, and trial entry after 1996. Differences existed between groups in tumor characteristics, toxicity, and survival, all which could affect resource utilization. Conclusions: Although we were able to test the methodology of economic analysis alongside a clinical trial using Medicare data, the results may be difficult to translate to the entire trial population because of non-random missing data. Methods to improve Medicare data capture and matching to clinical trial samples are required.« less

Identifying emerging research collaborations and networks: method development.

PubMed

Dozier, Ann M; Martina, Camille A; O'Dell, Nicole L; Fogg, Thomas T; Lurie, Stephen J; Rubinstein, Eric P; Pearson, Thomas A

2014-03-01

Clinical and translational research is a multidisciplinary, collaborative team process. To evaluate this process, we developed a method to document emerging research networks and collaborations in our medical center to describe their productivity and viability over time. Using an e-mail survey, sent to 1,620 clinical and basic science full- and part-time faculty members, respondents identified their research collaborators. Initial analyses, using Pajek software, assessed the feasibility of using social network analysis (SNA) methods with these data. Nearly 400 respondents identified 1,594 collaborators across 28 medical center departments resulting in 309 networks with 5 or more collaborators. This low-burden approach yielded a rich data set useful for evaluation using SNA to: (a) assess networks at several levels of the organization, including intrapersonal (individuals), interpersonal (social), organizational/institutional leadership (tenure and promotion), and physical/environmental (spatial proximity) and (b) link with other data to assess the evolution of these networks.

Feasibility of a novel one-stop ISET device to capture CTCs and its clinical application

PubMed Central

Zheng, Liang; Zhi, Xuan; Cheng, Boran; Chen, Yuanyuan; Zhang, Chunxiao; Shi, Dongdong; Song, Haibin; Cai, Congli; Zhou, Pengfei; Xiong, Bin

2017-01-01

Introduction Circulating tumor cells (CTCs) play a crucial role in cancer metastasis. In this study, we introduced a novel isolation method by size of epithelial tumor cells (ISET) device with automatic isolation and staining procedure, named one-stop ISET (osISET) and validated its feasibility to capture CTCs from cancer patients. Moreover, we aim to investigate the correlation between clinicopathologic features and CTCs in colorectal cancer (CRC) in order to explore its clinical application. Results The capture efficiency ranged from 80.3% to 88% with tumor cells spiked into medium while 67% to 78.3% with tumor cells spiked into healthy donors’ blood. In detection blood samples of 72 CRC patients, CTCs and clusters of circulating tumor cells (CTC-clusters) were detected with a positive rate of 52.8% (38/72) and 18.1% (13/72) respectively. Moreover, CTC positive rate was associated with factors of lymphatic or venous invasion, tumor depth, lymph node metastasis and TNM stage in CRC patients (p < 0.01). Lymphocyte count and neutrophil to lymphocyte ratio (NLR) were significantly different between CTC positive and negative groups (p < 0.01). Materials and Methods The capture efficiency of the device was tested by spiking cancer cells (MCF-7, A549, SW480, Hela) into medium or blood samples of healthy donors. Blood samples of 72 CRC patients were detected by osISET device. The clinicopathologic characteristics of 72 CRC patients were collected and the association with CTC positive rate or CTC count were analyzed. Conclusions Our osISET device was feasible to capture and identify CTCs and CTC-clusters from cancer patients. In addition, our device holds a potential for application in cancer management. PMID:27935872

A multimodal image guiding system for Navigated Ultrasound Bronchoscopy (EBUS): A human feasibility study

PubMed Central

Hofstad, Erlend Fagertun; Amundsen, Tore; Langø, Thomas; Bakeng, Janne Beate Lervik; Leira, Håkon Olav

2017-01-01

Background Endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA) is the endoscopic method of choice for confirming lung cancer metastasis to mediastinal lymph nodes. Precision is crucial for correct staging and clinical decision-making. Navigation and multimodal imaging can potentially improve EBUS-TBNA efficiency. Aims To demonstrate the feasibility of a multimodal image guiding system using electromagnetic navigation for ultrasound bronchoschopy in humans. Methods Four patients referred for lung cancer diagnosis and staging with EBUS-TBNA were enrolled in the study. Target lymph nodes were predefined from the preoperative computed tomography (CT) images. A prototype convex probe ultrasound bronchoscope with an attached sensor for position tracking was used for EBUS-TBNA. Electromagnetic tracking of the ultrasound bronchoscope and ultrasound images allowed fusion of preoperative CT and intraoperative ultrasound in the navigation software. Navigated EBUS-TBNA was used to guide target lymph node localization and sampling. Navigation system accuracy was calculated, measured by the deviation between lymph node position in ultrasound and CT in three planes. Procedure time, diagnostic yield and adverse events were recorded. Results Preoperative CT and real-time ultrasound images were successfully fused and displayed in the navigation software during the procedures. Overall navigation accuracy (11 measurements) was 10.0 ± 3.8 mm, maximum 17.6 mm, minimum 4.5 mm. An adequate sample was obtained in 6/6 (100%) of targeted lymph nodes. No adverse events were registered. Conclusions Electromagnetic navigated EBUS-TBNA was feasible, safe and easy in this human pilot study. The clinical usefulness was clearly demonstrated. Fusion of real-time ultrasound, preoperative CT and electromagnetic navigational bronchoscopy provided a controlled guiding to level of target, intraoperative overview and procedure documentation. PMID:28182758

Implementation of a lung cancer multidisciplinary team standardised template for reporting to general practitioners: a mixed-method study

PubMed Central

Collett, Gemma K; Brown, Clare M; Shaw, Tim J; White, Kahren M; Beale, Philip J; Anderiesz, Cleola; Barnes, David J

2017-01-01

Objectives Few interventions have been designed that provide standardised information to primary care clinicians about the diagnostic and treatment recommendations resulting from cancer multidisciplinary team (MDT) (tumour board) meetings. This study aimed to develop, implement and evaluate a standardised template for lung cancer MDTs to provide clinical information and treatment recommendations to general practitioners (GPs). Specific objectives were to (1) evaluate template feasibility (acceptability, appropriateness and timeliness) with GPs and (2) document processes of preimplementation, implementation and evaluation within the MDT setting. Design A mixed-method study design using structured interviews with GPs and qualitative documentation of project logs about implementation processes. Setting Two hospitals in Central Sydney, New South Wales, Australia. Participants: 61 GPs evaluated the template. Two lung cancer MDTs, consisting of 33 clinicians, and eight researchers participated in template development and implementation strategy. Results The MDT-reporting template appears to be a feasible way of providing clinical information to GPs following patient presentation at a lung cancer MDT meeting. Ninety-five per cent of GPs strongly agreed or agreed that the standardised template provided useful and relevant information, that it was received in a timely manner (90%) and that the information was easy to interpret and communicate to the patient (84%). Implementation process data show that the investment made in the preimplementation stage to integrate the template into standard work practices was a critical factor in successful implementation. Conclusions This study demonstrates that it is feasible to provide lung cancer MDT treatment recommendations to GPs through implementation of a standardised template. A simple intervention, such as a standardised template, can help to address quality gaps and ensure that timely information is communicated between tertiary and primary care healthcare providers. PMID:29288182

Gene therapy in dentistry: tool of genetic engineering. Revisited.

PubMed

Gupta, Khushboo; Singh, Saurabh; Garg, Kavita Nitish

2015-03-01

Advances in biotechnology have brought gene therapy to the forefront of medical research. The concept of transferring genes to tissues for clinical applications has been discussed nearly half a century, but the ability to manipulate genetic material via recombinant DNA technology has brought this goal to reality. The feasibility of gene transfer was first demonstrated using tumour viruses. This led to development of viral and nonviral methods for the genetic modification of somatic cells. Applications of gene therapy to dental and oral problems illustrate the potential impact of this technology on dentistry. Preclinical trial results regarding the same have been very promising. In this review we will discuss methods, vectors involved, clinical implication in dentistry and scientific issues associated with gene therapy. Copyright © 2014 Elsevier Ltd. All rights reserved.

76 FR 80947 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-12-27

... for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human Studies... feasibility studies of medical devices, using appropriate risk mitigation strategies, under the... comments on the key principles unique to the justification for, and design of, early feasibility studies...

3D automatic anatomy segmentation based on iterative graph-cut-ASM

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

Chen, Xinjian; Bagci, Ulas; Radiology and Imaging Sciences, Clinical Center, National Institutes of Health, Building 10 Room 1C515, Bethesda, Maryland 20892-1182

2011-08-15

Purpose: This paper studies the feasibility of developing an automatic anatomy segmentation (AAS) system in clinical radiology and demonstrates its operation on clinical 3D images. Methods: The AAS system, the authors are developing consists of two main parts: object recognition and object delineation. As for recognition, a hierarchical 3D scale-based multiobject method is used for the multiobject recognition task, which incorporates intensity weighted ball-scale (b-scale) information into the active shape model (ASM). For object delineation, an iterative graph-cut-ASM (IGCASM) algorithm is proposed, which effectively combines the rich statistical shape information embodied in ASM with the globally optimal delineation capability ofmore » the GC method. The presented IGCASM algorithm is a 3D generalization of the 2D GC-ASM method that they proposed previously in Chen et al.[Proc. SPIE, 7259, 72590C1-72590C-8 (2009)]. The proposed methods are tested on two datasets comprised of images obtained from 20 patients (10 male and 10 female) of clinical abdominal CT scans, and 11 foot magnetic resonance imaging (MRI) scans. The test is for four organs (liver, left and right kidneys, and spleen) segmentation, five foot bones (calcaneus, tibia, cuboid, talus, and navicular). The recognition and delineation accuracies were evaluated separately. The recognition accuracy was evaluated in terms of translation, rotation, and scale (size) error. The delineation accuracy was evaluated in terms of true and false positive volume fractions (TPVF, FPVF). The efficiency of the delineation method was also evaluated on an Intel Pentium IV PC with a 3.4 GHZ CPU machine. Results: The recognition accuracies in terms of translation, rotation, and scale error over all organs are about 8 mm, 10 deg. and 0.03, and over all foot bones are about 3.5709 mm, 0.35 deg. and 0.025, respectively. The accuracy of delineation over all organs for all subjects as expressed in TPVF and FPVF is 93.01% and 0.22%, and all foot bones for all subjects are 93.75% and 0.28%, respectively. While the delineations for the four organs can be accomplished quite rapidly with average of 78 s, the delineations for the five foot bones can be accomplished with average of 70 s. Conclusions: The experimental results showed the feasibility and efficacy of the proposed automatic anatomy segmentation system: (a) the incorporation of shape priors into the GC framework is feasible in 3D as demonstrated previously for 2D images; (b) our results in 3D confirm the accuracy behavior observed in 2D. The hybrid strategy IGCASM seems to be more robust and accurate than ASM and GC individually; and (c) delineations within body regions and foot bones of clinical importance can be accomplished quite rapidly within 1.5 min.« less

3D automatic anatomy segmentation based on iterative graph-cut-ASM

PubMed Central

Chen, Xinjian; Bagci, Ulas

2011-01-01

Purpose: This paper studies the feasibility of developing an automatic anatomy segmentation (AAS) system in clinical radiology and demonstrates its operation on clinical 3D images.Methods: The AAS system, the authors are developing consists of two main parts: object recognition and object delineation. As for recognition, a hierarchical 3D scale-based multiobject method is used for the multiobject recognition task, which incorporates intensity weighted ball-scale (b-scale) information into the active shape model (ASM). For object delineation, an iterative graph-cut-ASM (IGCASM) algorithm is proposed, which effectively combines the rich statistical shape information embodied in ASM with the globally optimal delineation capability of the GC method. The presented IGCASM algorithm is a 3D generalization of the 2D GC-ASM method that they proposed previously in Chen et al. [Proc. SPIE, 7259, 72590C1–72590C-8 (2009)]. The proposed methods are tested on two datasets comprised of images obtained from 20 patients (10 male and 10 female) of clinical abdominal CT scans, and 11 foot magnetic resonance imaging (MRI) scans. The test is for four organs (liver, left and right kidneys, and spleen) segmentation, five foot bones (calcaneus, tibia, cuboid, talus, and navicular). The recognition and delineation accuracies were evaluated separately. The recognition accuracy was evaluated in terms of translation, rotation, and scale (size) error. The delineation accuracy was evaluated in terms of true and false positive volume fractions (TPVF, FPVF). The efficiency of the delineation method was also evaluated on an Intel Pentium IV PC with a 3.4 GHZ CPU machine.Results: The recognition accuracies in terms of translation, rotation, and scale error over all organs are about 8 mm, 10° and 0.03, and over all foot bones are about 3.5709 mm, 0.35° and 0.025, respectively. The accuracy of delineation over all organs for all subjects as expressed in TPVF and FPVF is 93.01% and 0.22%, and all foot bones for all subjects are 93.75% and 0.28%, respectively. While the delineations for the four organs can be accomplished quite rapidly with average of 78 s, the delineations for the five foot bones can be accomplished with average of 70 s.Conclusions: The experimental results showed the feasibility and efficacy of the proposed automatic anatomy segmentation system: (a) the incorporation of shape priors into the GC framework is feasible in 3D as demonstrated previously for 2D images; (b) our results in 3D confirm the accuracy behavior observed in 2D. The hybrid strategy IGCASM seems to be more robust and accurate than ASM and GC individually; and (c) delineations within body regions and foot bones of clinical importance can be accomplished quite rapidly within 1.5 min. PMID:21928634

Feasibility of Web-based Technology to Assess Adherence to Clinic Appointments in Youth with Sickle Cell Disease

PubMed Central

Modi, Avani C.; Crosby, Lori E.; Hines, Janelle; Drotar, Dennis; Mitchell, Monica J.

2011-01-01

Web-based tools to improve clinic attendance have been effectively used in pediatric conditions but have not been tested in pediatric sickle cell disease (SCD). The goal of this pilot study was to assess barriers to clinic attendance and the feasibility of a web-based assessment tool to promote problem-solving around clinic appointments. Study participants included 30 youth with SCD (M=11.7±3.5 years; 57% male; 60% HbSS; 20% HbSC; 17% HB+Thal) and their primary caregivers. Medical chart review indicated that 61% of participants attended at least two SCD clinic appointments in the past year. The primary barrier to clinic attendance was inability to take off from work/school (33%). Regarding feasibility and acceptability, the computerized program was well-received by patients and caregivers, with youth and caregivers reporting a high degree of usefulness and preference for computerized assessment. Results suggest that this innovative approach shows promise and should be tested on a larger sample of youth with SCD. PMID:22278205

Foot orthoses in the treatment of symptomatic midfoot osteoarthritis using clinical and biomechanical outcomes: a randomised feasibility study.

PubMed

Halstead, Jill; Chapman, Graham J; Gray, Janine C; Grainger, Andrew J; Brown, Sarah; Wilkins, Richard A; Roddy, Edward; Helliwell, Philip S; Keenan, Anne-Maree; Redmond, Anthony C

2016-04-01

This randomised feasibility study aimed to examine the clinical and biomechanical effects of functional foot orthoses (FFOs) in the treatment of midfoot osteoarthritis (OA) and the feasibility of conducting a full randomised controlled trial. Participants with painful, radiographically confirmed midfoot OA were recruited and randomised to receive either FFOs or a sham control orthosis. Feasibility measures included recruitment and attrition rates, practicality of blinding and adherence rates. Clinical outcome measures were: change from baseline to 12 weeks for severity of pain (numerical rating scale), foot function (Manchester Foot Pain and Disability Index) and patient global impression of change scale. To investigate the biomechanical effect of foot orthoses, in-shoe foot kinematics and plantar pressures were evaluated at 12 weeks. Of the 119 participants screened, 37 were randomised and 33 completed the study (FFO = 18, sham = 15). Compliance with foot orthoses and blinding of the intervention was achieved in three quarters of the group. Both groups reported improvements in pain, function and global impression of change; the FFO group reporting greater improvements compared to the sham group. The biomechanical outcomes indicated the FFO group inverted the hindfoot and increased midfoot maximum plantar force compared to the sham group. The present findings suggest FFOs worn over 12 weeks may provide detectable clinical and biomechanical benefits compared to sham orthoses. This feasibility study provides useful clinical, biomechanical and statistical information for the design and implementation of a definitive randomised controlled trial to evaluate the effectiveness of FFOs in treating painful midfoot OA.

Feasibility, safety, and preliminary efficacy of Low Amplitude Seizure Therapy (LAP-ST): A proof of concept clinical trial in man.

PubMed

Youssef, Nagy A; Sidhom, Emad

2017-11-01

Current pulse amplitude used in clinical ECT may be higher than needed. Reducing pulse amplitude may improve focality of the electric field and thus cognitive adverse effects. Here we examine the feasibility, safety, and whether Low Pulse Amplitude Seizure Therapy (LAP-ST, 0.5-0.6A) minimizes cognitive adverse effects while retaining efficacy. Patients with treatment-resistant primary mood (depressive episodes) or psychotic disorders who were clinically indicated to undergo ECT were offered to be enrolled in an open-label study. The study consisted of a full acute course of LAP-ST under standard anesthesia and muscle relaxation. The primary outcome was feasibility of seizure induction. Clinical outcome measures were: time to reorientation (TRO), Mini Mental State Examination, Montgomery Aberg Depression Scale, and Brief Psychiatric Rating Scale, and Clinical Global Impression Scale. Twenty-two patients consented for enrollment in the study. LAP-ST was feasible, and all patients had seizures in the first session. Participants had a quick orientation with median TRO of 4.5min. Treatment was efficacious for both depressive and psychotic symptoms. Relatively small sample size, non-blinded, and no randomization was performed in this initial proof of concept study. This first human preliminary data of a full course of focal LAP-ST demonstrates that seizure induction is feasible. These results, although preliminary, suggest that the LAP-ST compared to the standard ECT techniques may result in less cognitive side effects, but comparable efficacy. Larger studies are needed to replicate these findings. Copyright © 2017 Elsevier B.V. All rights reserved.

Design and Validation of a Radio-Frequency Identification-Based Device for Routinely Assessing Gait Speed in a Geriatrics Clinic.

PubMed

Barry, Lisa C; Hatchman, Laura; Fan, Zhaoyan; Guralnik, Jack M; Gao, Robert X; Kuchel, George A

2018-05-01

To evaluate the feasibility, acceptability, and validity of a radio-frequency identification (RFID)-based system to measure gait speed in a clinical setting as a first step to using unobtrusive gait speed assessment in routine clinical care. Feasibility study comparing gait speed assessed using an RFID-based system with gait speed assessed using handheld stopwatch, the criterion standard. Outpatient geriatrics clinic at a Connecticut-based academic medical center. Clinic attendees who could walk independently with or without an assistive device (N=50) and healthcare providers (N=9). Gait speed was measured in twice using 2 methods each time before participants entered an examination room. Participants walked at their usual pace while gait speed was recorded simultaneously using the RFID-based system and a handheld stopwatch operated by a trained study investigator. After 2 trials, participants completed a brief survey regarding their experience. At the end of the study period, clinic healthcare providers completed a separate survey. Test-retest reliability of the RFID-based system was high (intraclass correlation coefficient = 0.953). The mean difference ± standard deviation in gait speed between the RFID-based system and the stopwatch was -0.003±0.035 m/s (p=.53) and did not differ significantly according to age, sex, or use of an assistive walking aid. Acceptability of the device was high, and 8 of 9 providers indicated that measuring gait speed using the RFID-based system should be a part of routine clinical care. RFID technology may offer a practical means of overcoming barriers to routine measurement of gait speed in real-world outpatient clinical settings. © 2018, Copyright the Authors Journal compilation © 2018, The American Geriatrics Society.

Assessing Clinical Trial–Associated Workload in Community-Based Research Programs Using the ASCO Clinical Trial Workload Assessment Tool

PubMed Central

Hurley, Patricia; Woo, Kaitlin M.; Szczepanek, Connie; Stewart, Teresa; Robert, Nicholas; Lyss, Alan; Gönen, Mithat; Lilenbaum, Rogerio

2016-01-01

Purpose: Clinical research program managers are regularly faced with the quandary of determining how much of a workload research staff members can manage while they balance clinical practice and still achieve clinical trial accrual goals, maintain data quality and protocol compliance, and stay within budget. A tool was developed to measure clinical trial–associated workload, to apply objective metrics toward documentation of work, and to provide clearer insight to better meet clinical research program challenges and aid in balancing staff workloads. A project was conducted to assess the feasibility and utility of using this tool in diverse research settings. Methods: Community-based research programs were recruited to collect and enter clinical trial–associated monthly workload data into a web-based tool for 6 consecutive months. Descriptive statistics were computed for self-reported program characteristics and workload data, including staff acuity scores and number of patient encounters. Results: Fifty-one research programs that represented 30 states participated. Median staff acuity scores were highest for staff with patients enrolled in studies and receiving treatment, relative to staff with patients in follow-up status. Treatment trials typically resulted in higher median staff acuity, relative to cancer control, observational/registry, and prevention trials. Industry trials exhibited higher median staff acuity scores than trials sponsored by the National Institutes of Health/National Cancer Institute, academic institutions, or others. Conclusion: The results from this project demonstrate that trial-specific acuity measurement is a better measure of workload than simply counting the number of patients. The tool was shown to be feasible and useable in diverse community-based research settings. PMID:27006354

Feasibility of rapid and automated importation of 3D echocardiographic left ventricular (LV) geometry into a finite element (FEM) analysis model

PubMed Central

Verhey, Janko F; Nathan, Nadia S

2004-01-01

Background Finite element method (FEM) analysis for intraoperative modeling of the left ventricle (LV) is presently not possible. Since 3D structural data of the LV is now obtainable using standard transesophageal echocardiography (TEE) devices intraoperatively, the present study describes a method to transfer this data into a commercially available FEM analysis system: ABAQUS©. Methods In this prospective study TomTec LV Analysis TEE© Software was used for semi-automatic endocardial border detection, reconstruction, and volume-rendering of the clinical 3D echocardiographic data. A newly developed software program MVCP FemCoGen©, written in Delphi, reformats the TomTec file structures in five patients for use in ABAQUS and allows visualization of regional deformation of the LV. Results This study demonstrates that a fully automated importation of 3D TEE data into FEM modeling is feasible and can be efficiently accomplished in the operating room. Conclusion For complete intraoperative 3D LV finite element analysis, three input elements are necessary: 1. time-gaited, reality-based structural information, 2. continuous LV pressure and 3. instantaneous tissue elastance. The first of these elements is now available using the methods presented herein. PMID:15473901

Using Educational Prescriptions to Teach Medical Students Evidence-based Medicine

PubMed Central

Umscheid, Craig A.; Maenner, Matthew J.; Mull, Nikhil; Veesenmeyer, Angela F.; Farrar, John T.; Goldfarb, Stanley; Morrison, Gail; Albanese, Mark A.; Frohna, John G.; Feldstein, David A.

2018-01-01

Purpose To evaluate feasibility and impact of evidence-based medicine (EBM) educational prescriptions (EPs) in medical student clerkships. Methods Students answered clinical questions during clerkships using EPs, which guide learners through the “four As” of EBM. Epidemiology fellows graded EPs using a rubric. Feasibility was assessed using descriptive statistics and student and fellow end-of-study questionnaires, which also measured impact. In addition, for each EP, students reported patient impact. Impact on EBM skills was assessed by change in EP scores over time and scores on an EBM objective structured clinical exam (OSCE) that were compared to controls from the prior year. Results 117 students completed 402 EPs evaluated by 24 fellows. Average score was 7.34/9.00 (SD 1.58). 69 students (59%) and 21 fellows (88%) completed questionnaires. Most students thought EPs improved “Acquiring” and “Appraising.” Almost half thought EPs improved “Asking” and “Applying.” Fellows did not value grading EPs. For 18%of EPs, students reported a “change” or “potential change” in treatment. 56% “confirmed” treatment. EP scores increased by 1.27 (95% CI: 0.81–1.72). There were no differences in OSCE scores between cohorts. Conclusions Integrating EPs into clerkships is feasible and has impact, yet OSCEs were unchanged, and research fellows had limitations as evaluators. PMID:27075864

E-learning to improve the drug prescribing in the hospitalized elderly patients: the ELICADHE feasibility pilot study.

PubMed

Franchi, C; Mari, D; Tettamanti, M; Pasina, L; Djade, C D; Mannucci, P M; Onder, G; Bernabei, R; Gussoni, G; Bonassi, S; Nobili, A

2014-08-01

E-learning is an efficient and cost-effective educational method. This study aimed at evaluating the feasibility of an educational e-learning intervention, focused on teaching geriatric pharmacology and notions of comprehensive geriatric assessment, to improve drug prescribing to hospitalized elderly patients. Eight geriatric and internal medicine wards were randomized to intervention (e-learning educational program) or control. Clinicians of the two groups had to complete a specific per group e-learning program in 30 days. Then, ten patients (aged ≥75 years) had to be consecutively enrolled collecting clinical data at hospital admission, discharge, and 3 months later. The quality of prescription was evaluated comparing the prevalence of potentially inappropriate medications through Beer's criteria and of potential drug-drug interactions through a specific computerized database. The study feasibility was confirmed by the high percentage (90 %) of clinicians who completed the e-learning program, the recruitment, and follow-up of all planned patients. The intervention was well accepted by all participating clinicians who judged positively (a mean score of >3 points on a scale of 5 points: 0 = useless; 5 = most useful) the specific contents, the methodology applied, the clinical relevance and utility of e-learning contents and tools for the evaluation of the appropriateness of drug prescribing. The pilot study met all the requested goals. The main study is currently ongoing and is planned to finish on July 2015.

Assessment of PlanIQ Feasibility DVH for head and neck treatment planning.

PubMed

Fried, David V; Chera, Bhishamjit S; Das, Shiva K

2017-09-01

Designing a radiation plan that optimally delivers both target coverage and normal tissue sparing is challenging. There are limited tools to determine what is dosimetrically achievable and frequently the experience of the planner/physician is relied upon to make these determinations. PlanIQ software provides a tool that uses target and organ at risk (OAR) geometry to indicate the difficulty of achieving different points for organ dose-volume histograms (DVH). We hypothesized that PlanIQ Feasibility DVH may aid planners in reducing dose to OARs. Clinically delivered head and neck treatments (clinical plan) were re-planned (re-plan) putting high emphasis on maximally sparing the contralateral parotid gland, contralateral submandibular gland, and larynx while maintaining routine clinical dosimetric objectives. The planner was blinded to the results of the clinically delivered plan as well as the Feasibility DVHs from PlanIQ. The re-plan treatments were designed using 3-arc VMAT in Raystation (RaySearch Laboratories, Sweden). The planner was then given the results from the PlanIQ Feasibility DVH analysis and developed an additional plan incorporating this information using 4-arc VMAT (IQ plan). The DVHs across the three treatment plans were compared with what was deemed "impossible" by PlanIQ's Feasibility DVH (Impossible DVH). The impossible DVH (red) is defined as the DVH generated using the minimal dose that any voxel outside the targets must receive given 100% target coverage. The re-plans performed blinded to PlanIQ Feasibilty DVH achieved superior sparing of aforementioned OARs compared to the clinically delivered plans and resulted in discrepancies from the impossible DVHs by an average of 200-700 cGy. Using the PlanIQ Feasibility DVH led to additionalOAR sparing compared to both the re-plans and clinical plans and reduced the discrepancies from the impossible DVHs to an average of approximately 100 cGy. The dose reduction from clinical to re-plan and re-plan to IQ plan were significantly different even when taking into account multiple hypothesis testing for both the contralateral parotid and the larynx (P < 0.004 for all comparisons). No significant differences were observed between the three plans for the contralateral parotid when considering multiple hypothesis testing. Clinical treatment plans and blinded re-plans were found to suboptimally spare OARs. PlanIQ could aid planners in generating treatment plans that push the limits of OAR sparing while maintaining routine clinical target coverage goals. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Patients' use of digital audio recordings in four different outpatient clinics.

PubMed

Wolderslund, Maiken; Kofoed, Poul-Erik; Holst, René; Ammentorp, Jette

2015-12-01

To investigate a new technology of digital audio recording (DAR) of health consultations to provide knowledge about patients' use and evaluation of this recording method. A cross-sectional feasibility analysis of the intervention using log data from the recording platform and data from a patient-administered questionnaire. Four different outpatient clinics at a Danish hospital: Paediatrics, Orthopaedics, Internal Medicine and Urology. Two thousand seven hundred and eighty-four outpatients having their consultation audio recorded by one of 49 participating health professionals. DAR of outpatient consultations provided to patients permitting replay of their consultation either alone or together with their relatives. Replay of the consultation within 90 days from the consultation. In the adult outpatient clinics, one in every three consultations was replayed; however, the rates were significantly lower in the paediatric clinic where one in five consultations was replayed. The usage of the audio recordings was positively associated with increasing patient age and first time visits to the clinic. Patient gender influenced replays in different ways; for instance, relatives to male patients replayed recordings more often than relatives to female patients did. Approval of future recordings was high among the patients who replayed the consultation. Patients found that recording health consultations was an important information aid, and the digital recording technology was found to be feasible in routine practice. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

[ANSYS simulation of subcutaneous pustule electrical characteristics].

PubMed

Liu, Baohua; Wang, Xuan; Zhu, Honglian; Wang, Guoyong

2011-12-01

With the growing number of clinical surgery, post-operative surgical wound infection has become a very difficult clinical problem. In the treatments of it, non-invasive test of wound infection and healing status has a significance in clinical medicine practice. In this paper, beginning with the electrical properties of skin tissue structure and on the basis of the electromagnetism and the human anatomy, using the finite element analysis software, we applied safe voltage on the 3D skin model, performed the subcutaneous pustule simulation study and gained the relational curve between depth and radius of the pustule model. The simulation results suggested that the method we put forward could be feasible, and it could provide basis for non-invasive detection of wound healing and wound infection status.

Metabolic impact of partial volume correction of [18F]FDG PET-CT oncological studies on the assessment of tumor response to treatment.

PubMed

Stefano, A; Gallivanone, F; Messa, C; Gilardi, M C; Gastiglioni, I

2014-12-01

The aim of this work is to evaluate the metabolic impact of Partial Volume Correction (PVC) on the measurement of the Standard Uptake Value (SUV) from [18F]FDG PET-CT oncological studies for treatment monitoring purpose. Twenty-nine breast cancer patients with bone lesions (42 lesions in total) underwent [18F]FDG PET-CT studies after surgical resection of breast cancer primitives, and before (PET-II) chemotherapy and hormone treatment. PVC of bone lesion uptake was performed on the two [18F]FDG PET-CT studies, using a method based on Recovery Coefficients (RC) and on an automatic measurement of lesion metabolic volume. Body-weight average SUV was calculated for each lesion, with and without PVC. The accuracy, reproducibility, clinical feasibility and the metabolic impact on treatment response of the considered PVC method was evaluated. The PVC method was found clinically feasible in bone lesions, with an accuracy of 93% for lesion sphere-equivalent diameter >1 cm. Applying PVC, average SUV values increased, from 7% up to 154% considering both PET-I and PET-II studies, proving the need of the correction. As main finding, PVC modified the therapy response classification in 6 cases according to EORTC 1999 classification and in 5 cases according to PERCIST 1.0 classification. PVC has an important metabolic impact on the assessment of tumor response to treatment by [18F]FDG PET-CT oncological studies.

The measurement of patient attitudes regarding prenatal and preconception genetic carrier screening and translational behavioral medicine: an integrative review.

PubMed

Shiroff, Jennifer J; Gregoski, Mathew J

2017-06-01

Measurement of recessive carrier screening attitudes related to conception and pregnancy is necessary to determine current acceptance, and whether behavioral intervention strategies are needed in clinical practice. To evaluate quantitative survey instruments to measure patient attitudes regarding genetic carrier testing prior to conception and pregnancy databases examining patient attitudes regarding genetic screening prior to conception and pregnancy from 2003-2013 were searched yielding 344 articles; eight studies with eight instruments met criteria for inclusion. Data abstraction on theoretical framework, subjects, instrument description, scoring, method of measurement, reliability, validity, feasibility, level of evidence, and outcomes was completed. Reliability information was provided in five studies with an internal consistency of Cronbach's α >0.70. Information pertaining to validity was presented in three studies and included construct validity via factor analysis. Despite limited psychometric information, these questionnaires are self-administered and can be briefly completed, making them a feasible method of evaluation.

Usability and feasibility of mobile phone diaries in an experimental physical exercise study.

PubMed

Heinonen, Reetta; Luoto, Riitta; Lindfors, Pirjo; Nygård, Clas-Håkan

2012-03-01

Wireless and mobile phone technology as a method of data collection will increase alongside conventional methods. The aim of the present study was to evaluate the use of a mobile phone application for recording symptoms and physical activity exertion during an experimental physical exercise study. An experimental study on the effects of physical exercise on the well-being of menopausal women included 158 subjects between 44 and 63 years of age. The women were randomized into intervention and control groups. All participants in both groups reported daily symptoms by responding to morning and evening questionnaires via mobile phones. The usability of the mobile phone as a data collector tool was evaluated with the System Usability Scale (SUS) questionnaire 2 months after the intervention. The feasibility evaluation was based on the frequency of responses and open questions. The response rates were about 70% to both morning and evening questionnaires. The average frequency of responses (n =158) to morning questionnaires was 125 (±40)/170 (±14) and to evening questionnaires was 118 (±40)/171 (±14). The response rate did not differ between the intervention and the control groups. The SUS score was on average 75.4 (range, 0-100; n =107). A mobile phone diary is a feasible and usable tool for data collection in clinical trials.

Statistical process control: A feasibility study of the application of time-series measurement in early neurorehabilitation after acquired brain injury.

PubMed

Markovic, Gabriela; Schult, Marie-Louise; Bartfai, Aniko; Elg, Mattias

2017-01-31

Progress in early cognitive recovery after acquired brain injury is uneven and unpredictable, and thus the evaluation of rehabilitation is complex. The use of time-series measurements is susceptible to statistical change due to process variation. To evaluate the feasibility of using a time-series method, statistical process control, in early cognitive rehabilitation. Participants were 27 patients with acquired brain injury undergoing interdisciplinary rehabilitation of attention within 4 months post-injury. The outcome measure, the Paced Auditory Serial Addition Test, was analysed using statistical process control. Statistical process control identifies if and when change occurs in the process according to 3 patterns: rapid, steady or stationary performers. The statistical process control method was adjusted, in terms of constructing the baseline and the total number of measurement points, in order to measure a process in change. Statistical process control methodology is feasible for use in early cognitive rehabilitation, since it provides information about change in a process, thus enabling adjustment of the individual treatment response. Together with the results indicating discernible subgroups that respond differently to rehabilitation, statistical process control could be a valid tool in clinical decision-making. This study is a starting-point in understanding the rehabilitation process using a real-time-measurements approach.

A nurse-run clinic for patients with incidentally discovered small abdominal aortic aneurysms is feasible and cost-effective.

PubMed

Griffin, J L; Clarke, G A; Roake, J A; Lewis, D R

2015-04-01

Patients with incidentally discovered small abdominal aortic aneurysms (AAA) require assessment by a vascular surgery department for possible enrollment in a surveillance programme. Our unit implemented a vascular nurse-run AAA clinic in October 2010. The aim of this study was to assess the feasibility of a specialist nurse-run small AAA clinic. Demographic and clinical data were collected prospectively for all patients seen in the new vascular nurse clinic between October 2010 and November 2012. A validated AAA operative mortality score was used to aid decision making by the vascular nurse. Some 250 patients were seen in the clinic. 198 (79.2%) patients were enrolled in surveillance, 40 (16%) declined enrollment and 12 (4.8%) were referred to a consultant clinic for further assessment. The majority of patients were male and the mean age was 73.7 years. Co-morbidities included hypertension, a history of cardiovascular disease, and hyperlipidaemia. The majority of referrals were considered to be low operative risk. No aneurysms ruptured whilst under surveillance. A nurse-run clinic that assesses patients with incidentally discovered small AAAs for inclusion in AAA surveillance is a feasible alternative to assessment of these patients in a consultant-run clinic. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.

Region specific optimization of continuous linear attenuation coefficients based on UTE (RESOLUTE): application to PET/MR brain imaging

NASA Astrophysics Data System (ADS)

Ladefoged, Claes N.; Benoit, Didier; Law, Ian; Holm, Søren; Kjær, Andreas; Højgaard, Liselotte; Hansen, Adam E.; Andersen, Flemming L.

2015-10-01

The reconstruction of PET brain data in a PET/MR hybrid scanner is challenging in the absence of transmission sources, where MR images are used for MR-based attenuation correction (MR-AC). The main challenge of MR-AC is to separate bone and air, as neither have a signal in traditional MR images, and to assign the correct linear attenuation coefficient to bone. The ultra-short echo time (UTE) MR sequence was proposed as a basis for MR-AC as this sequence shows a small signal in bone. The purpose of this study was to develop a new clinically feasible MR-AC method with patient specific continuous-valued linear attenuation coefficients in bone that provides accurate reconstructed PET image data. A total of 164 [18F]FDG PET/MR patients were included in this study, of which 10 were used for training. MR-AC was based on either standard CT (reference), UTE or our method (RESOLUTE). The reconstructed PET images were evaluated in the whole brain, as well as regionally in the brain using a ROI-based analysis. Our method segments air, brain, cerebral spinal fluid, and soft tissue voxels on the unprocessed UTE TE images, and uses a mapping of R2* values to CT Hounsfield Units (HU) to measure the density in bone voxels. The average error of our method in the brain was 0.1% and less than 1.2% in any region of the brain. On average 95% of the brain was within  ±10% of PETCT, compared to 72% when using UTE. The proposed method is clinically feasible, reducing both the global and local errors on the reconstructed PET images, as well as limiting the number and extent of the outliers.

Structured assessment of microsurgery skills in the clinical setting.

PubMed

Chan, WoanYi; Niranjan, Niri; Ramakrishnan, Venkat

2010-08-01

Microsurgery is an essential component in plastic surgery training. Competence has become an important issue in current surgical practice and training. The complexity of microsurgery requires detailed assessment and feedback on skills components. This article proposes a method of Structured Assessment of Microsurgery Skills (SAMS) in a clinical setting. Three types of assessment (i.e., modified Global Rating Score, errors list and summative rating) were incorporated to develop the SAMS method. Clinical anastomoses were recorded on videos using a digital microscope system and were rated by three consultants independently and in a blinded fashion. Fifteen clinical cases of microvascular anastomoses performed by trainees and a consultant microsurgeon were assessed using SAMS. The consultant had consistently the highest scores. Construct validity was also demonstrated by improvement of SAMS scores of microsurgery trainees. The overall inter-rater reliability was strong (alpha=0.78). The SAMS method provides both formative and summative assessment of microsurgery skills. It is demonstrated to be a valid, reliable and feasible assessment tool of operating room performance to provide systematic and comprehensive feedback as part of the learning cycle. Copyright 2009 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.

SNOMED CT module-driven clinical archetype management.

PubMed

Allones, J L; Taboada, M; Martinez, D; Lozano, R; Sobrido, M J

2013-06-01

To explore semantic search to improve management and user navigation in clinical archetype repositories. In order to support semantic searches across archetypes, an automated method based on SNOMED CT modularization is implemented to transform clinical archetypes into SNOMED CT extracts. Concurrently, query terms are converted into SNOMED CT concepts using the search engine Lucene. Retrieval is then carried out by matching query concepts with the corresponding SNOMED CT segments. A test collection of the 16 clinical archetypes, including over 250 terms, and a subset of 55 clinical terms from two medical dictionaries, MediLexicon and MedlinePlus, were used to test our method. The keyword-based service supported by the OpenEHR repository offered us a benchmark to evaluate the enhancement of performance. In total, our approach reached 97.4% precision and 69.1% recall, providing a substantial improvement of recall (more than 70%) compared to the benchmark. Exploiting medical domain knowledge from ontologies such as SNOMED CT may overcome some limitations of the keyword-based systems and thus improve the search experience of repository users. An automated approach based on ontology segmentation is an efficient and feasible way for supporting modeling, management and user navigation in clinical archetype repositories. Copyright © 2013 Elsevier Inc. All rights reserved.

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

The Translational Science Benefits Model: A New Framework for Assessing the Health and Societal Benefits of Clinical and Translational Sciences

PubMed Central

Sarli, Cathy C.; Suiter, Amy M.; Carothers, Bobbi J.; Combs, Todd B.; Allen, Jae L.; Beers, Courtney E.; Evanoff, Bradley A.

2017-01-01

Abstract We report the development of the Translational Science Benefits Model (TSBM), a framework designed to support institutional assessment of clinical and translational research outcomes to measure clinical and community health impacts beyond bibliometric measures. The TSBM includes 30 specific and potentially measurable indicators that reflect benefits that accrue from clinical and translational science research such as products, system characteristics, or activities. Development of the TSBM was based on literature review, a modified Delphi method, and in‐house expert panel feedback. Three case studies illustrate the feasibility and face validity of the TSBM for identification of clinical and community health impacts that result from translational science activities. Future plans for the TSBM include further pilot testing and a resource library that will be freely available for evaluators, translational scientists, and academic institutions who wish to implement the TSBM framework in their own evaluation efforts. PMID:28887873

Answering medical questions at the point of care: a cross-sectional study comparing rapid decisions based on PubMed and Epistemonikos searches with evidence-based recommendations developed with the GRADE approach.

PubMed

Izcovich, Ariel; Criniti, Juan Martín; Popoff, Federico; Ragusa, Martín Alberto; Gigler, Cristel; Gonzalez Malla, Carlos; Clavijo, Manuela; Manzotti, Matias; Diaz, Martín; Catalano, Hugo Norberto; Neumann, Ignacio; Guyatt, Gordon

2017-08-07

Using the best current evidence to inform clinical decisions remains a challenge for clinicians. Given the scarcity of trustworthy clinical practice guidelines providing recommendations to answer clinicians' daily questions, clinical decision support systems (ie, assistance in question identification and answering) emerge as an attractive alternative. The trustworthiness of the recommendations achieved by such systems is unknown. To evaluate the trustworthiness of a question identification and answering system that delivers timely recommendations. Cross-sectional study. We compared the responses to 100 clinical questions related to inpatient management provided by two rapid response methods with 'Gold Standard' recommendations. One of the rapid methods was based on PubMed and the other on Epistemonikos database. We defined our 'Gold Standard' as trustworthy published evidence-based recommendations or, when unavailable, recommendations developed locally by a panel of six clinicians following the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Recommendations provided by the rapid strategies were classified as potentially misleading or reasonable. We also determined if the potentially misleading recommendations could have been avoided with the appropriate implementation of searching and evidence summary tools. We were able to answer all of the 100 questions with both rapid methods. Of the 200 recommendations obtained, 6.5% (95% CI 3% to 9.9%) were classified as potentially misleading and 93.5% (95% CI 90% to 96.9%) as reasonable. 6 of the 13 potentially misleading recommendations could have been avoided by the appropriate usage of the Epistemonikos matrix tool or by constructing summary of findings tables. No significant differences were observed between the evaluated rapid response methods. A question answering service based on the GRADE approach proved feasible to implement and provided appropriate guidance for most identified questions. Our approach could help stakeholders in charge of managing resources and defining policies for patient care to improve evidence-based decision-making in an efficient and feasible manner. © 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.

SU-E-T-175: Clinical Evaluations of Monte Carlo-Based Inverse Treatment Plan Optimization for Intensity Modulated Radiotherapy

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

Chi, Y; Li, Y; Tian, Z

2015-06-15

Purpose: Pencil-beam or superposition-convolution type dose calculation algorithms are routinely used in inverse plan optimization for intensity modulated radiation therapy (IMRT). However, due to their limited accuracy in some challenging cases, e.g. lung, the resulting dose may lose its optimality after being recomputed using an accurate algorithm, e.g. Monte Carlo (MC). It is the objective of this study to evaluate the feasibility and advantages of a new method to include MC in the treatment planning process. Methods: We developed a scheme to iteratively perform MC-based beamlet dose calculations and plan optimization. In the MC stage, a GPU-based dose engine wasmore » used and the particle number sampled from a beamlet was proportional to its optimized fluence from the previous step. We tested this scheme in four lung cancer IMRT cases. For each case, the original plan dose, plan dose re-computed by MC, and dose optimized by our scheme were obtained. Clinically relevant dosimetric quantities in these three plans were compared. Results: Although the original plan achieved a satisfactory PDV dose coverage, after re-computing doses using MC method, it was found that the PTV D95% were reduced by 4.60%–6.67%. After re-optimizing these cases with our scheme, the PTV coverage was improved to the same level as in the original plan, while the critical OAR coverages were maintained to clinically acceptable levels. Regarding the computation time, it took on average 144 sec per case using only one GPU card, including both MC-based beamlet dose calculation and treatment plan optimization. Conclusion: The achieved dosimetric gains and high computational efficiency indicate the feasibility and advantages of the proposed MC-based IMRT optimization method. Comprehensive validations in more patient cases are in progress.« less

Head Transplantation in Mouse Model.

PubMed

Ren, Xiao-Ping; Ye, Yi-Jie; Li, Peng-Wei; Shen, Zi-Long; Han, Ke-Cheng; Song, Yang

2015-08-01

The mouse model of allo-head and body reconstruction (AHBR) has recently been established to further the clinical development of this strategy for patients who are suffering from mortal bodily trauma or disease, yet whose mind remains healthy. Animal model studies are indispensable for developing such novel surgical practices. The goal of this work was to establish head transplant mouse model, then the next step through the feasible biological model to investigate immune rejection and brain function in next step, thereby promoting the goal of translation of AHBR to the clinic in the future. Our approach involves retaining adequate blood perfusion in the transplanted head throughout the surgical procedure by establishing donor-to-recipient cross-circulation by cannulating and anastomosing the carotid artery on one side of the body and the jugular vein on the other side. Neurological function was preserved by this strategy as indicated by electroencephalogram and intact cranial nerve reflexes. The results of this study support the feasibility of this method for avoiding brain ischemia during transplantation, thereby allowing for the possibility of long-term studies of head transplantation. © 2015 John Wiley & Sons Ltd.

High-Pressure Transvenous Perfusion of the Upper Extremity in Human Muscular Dystrophy: A Safety Study with 0.9% Saline.

PubMed

Fan, Zheng; Kocis, Keith; Valley, Robert; Howard, James F; Chopra, Manisha; Chen, Yasheng; An, Hongyu; Lin, Weili; Muenzer, Joseph; Powers, William

2015-09-01

We evaluated safety and feasibility of high-pressure transvenous limb perfusion in an upper extremity of adult patients with muscular dystrophy, after completing a similar study in a lower extremity. A dose escalation study of single-limb perfusion with 0.9% saline was carried out in nine adults with muscular dystrophies under intravenous analgesia. Our study demonstrates that it is feasible and definitely safe to perform high-pressure transvenous perfusion with 0.9% saline up to 35% of limb volume in the upper extremities of young adults with muscular dystrophy. Perfusion at 40% limb volume is associated with short-lived physiological changes in peripheral nerves without clinical correlates in one subject. This study provides the basis for a phase 1/2 clinical trial using pressurized transvenous delivery into upper limbs of nonambulatory patients with Duchenne muscular dystrophy. Furthermore, our results are applicable to other conditions such as limb girdle muscular dystrophy as a method for delivering regional macromolecular therapeutics in high dose to skeletal muscles of the upper extremity.

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

Koren, S; Bragilovski, D; Tafo, A Guemnie

Purpose: To evaluate the clinical feasibility of IntraBeam intra operative kV irradiation beam device for ocular conjunctiva treatments. The Intra-Beam system offers a 4.4 mm diameter needle applicator, that is not suitable for treatment of a large surface with limits access. We propose an adaptor that will answer to this clinical need and provide initial dosimetry. Methods: The dose distribution of the needle applicator is non uniform and hence not suitable for treatment of relatively large surfaces. We designed an adapter to the needle applicator that will filter the X-rays and produce a conformal dose distribution over the treatment areamore » while shielding surfaces to be spared. Dose distributions were simulated using FLUKA is a fully integrated particle physics Monte Carlo simulation package. Results: We designed a wedge applicator made of Polythermide window and stainless steel for collimating. We compare the dose distribution to that of the known needle and surface applicators. Conclusion: Initial dosimetry shows feasibility of this approach. While further refinements to the design may be warranted, the results support construction of a prototype and confirmation of the Monte Carlo dosimetry with measured data.« less

Clinical evaluation of semi-automatic open-source algorithmic software segmentation of the mandibular bone: Practical feasibility and assessment of a new course of action

PubMed Central

Wallner, Jürgen; Hochegger, Kerstin; Chen, Xiaojun; Mischak, Irene; Reinbacher, Knut; Pau, Mauro; Zrnc, Tomislav; Schwenzer-Zimmerer, Katja; Zemann, Wolfgang; Schmalstieg, Dieter

2018-01-01

Introduction Computer assisted technologies based on algorithmic software segmentation are an increasing topic of interest in complex surgical cases. However—due to functional instability, time consuming software processes, personnel resources or licensed-based financial costs many segmentation processes are often outsourced from clinical centers to third parties and the industry. Therefore, the aim of this trial was to assess the practical feasibility of an easy available, functional stable and licensed-free segmentation approach to be used in the clinical practice. Material and methods In this retrospective, randomized, controlled trail the accuracy and accordance of the open-source based segmentation algorithm GrowCut was assessed through the comparison to the manually generated ground truth of the same anatomy using 10 CT lower jaw data-sets from the clinical routine. Assessment parameters were the segmentation time, the volume, the voxel number, the Dice Score and the Hausdorff distance. Results Overall semi-automatic GrowCut segmentation times were about one minute. Mean Dice Score values of over 85% and Hausdorff Distances below 33.5 voxel could be achieved between the algorithmic GrowCut-based segmentations and the manual generated ground truth schemes. Statistical differences between the assessment parameters were not significant (p<0.05) and correlation coefficients were close to the value one (r > 0.94) for any of the comparison made between the two groups. Discussion Complete functional stable and time saving segmentations with high accuracy and high positive correlation could be performed by the presented interactive open-source based approach. In the cranio-maxillofacial complex the used method could represent an algorithmic alternative for image-based segmentation in the clinical practice for e.g. surgical treatment planning or visualization of postoperative results and offers several advantages. Due to an open-source basis the used method could be further developed by other groups or specialists. Systematic comparisons to other segmentation approaches or with a greater data amount are areas of future works. PMID:29746490

Large-Scale Wearable Sensor Deployment in Parkinson’s Patients: The Parkinson@Home Study Protocol

PubMed Central

Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

2016-01-01

Background Long-term management of Parkinson’s disease does not reach its full potential because we lack knowledge about individual variations in clinical presentation and disease progression. Continuous and longitudinal assessments in real-life (ie, within the patients’ own home environment) might fill this knowledge gap. Objective The primary aim of the Parkinson@Home study is to evaluate the feasibility and compliance of using multiple wearable sensors to collect clinically relevant data. Our second aim is to address the usability of these data for answering clinical research questions. Finally, we aim to build a database for future validation of novel algorithms applied to sensor-derived data from Parkinson’s patients during daily functioning. Methods The Parkinson@Home study is a two-phase observational study involving 1000 Parkinson’s patients and 250 physiotherapists. Disease status is assessed using a short version of the Parkinson's Progression Markers Initiative protocol, performed by certified physiotherapists. Additionally, participants will wear a set of sensors (smartwatch, smartphone, and fall detector), and use these together with a customized smartphone app (Fox Insight), 24/7 for 3 months. The sensors embedded within the smartwatch and fall detector may be used to estimate physical activity, tremor, sleep quality, and falls. Medication intake and fall incidents will be measured via patients’ self-reports in the smartphone app. Phase one will address the feasibility of the study protocol. In phase two, mathematicians will distill relevant summary statistics from the raw sensor signals, which will be compared against the clinical outcomes. Results Recruitment of 300 participants for phase one was concluded in March, 2016, and the follow-up period will end in June, 2016. Phase two will include the remaining participants, and will commence in September, 2016. Conclusions The Parkinson@Home study is expected to generate new insights into the feasibility of integrating self-collected information from wearable sensors into both daily routines and clinical practices for Parkinson’s patients. This study represents an important step towards building a reliable system that translates and integrates real-life information into clinical decisions, with the long-term aim of delivering personalized disease management support. ClinicalTrial ClinicalTrials.gov NCT02474329; https://clinicaltrials.gov/ct2/show/NCT02474329 (Archived at http://www.webcitation.org/6joEc5P1v) PMID:27565186

Whole genome sequencing in clinical and public health microbiology

PubMed Central

Kwong, J. C.; McCallum, N.; Sintchenko, V.; Howden, B. P.

2015-01-01

SummaryGenomics and whole genome sequencing (WGS) have the capacity to greatly enhance knowledge and understanding of infectious diseases and clinical microbiology. The growth and availability of bench-top WGS analysers has facilitated the feasibility of genomics in clinical and public health microbiology. Given current resource and infrastructure limitations, WGS is most applicable to use in public health laboratories, reference laboratories, and hospital infection control-affiliated laboratories. As WGS represents the pinnacle for strain characterisation and epidemiological analyses, it is likely to replace traditional typing methods, resistance gene detection and other sequence-based investigations (e.g., 16S rDNA PCR) in the near future. Although genomic technologies are rapidly evolving, widespread implementation in clinical and public health microbiology laboratories is limited by the need for effective semi-automated pipelines, standardised quality control and data interpretation, bioinformatics expertise, and infrastructure. PMID:25730631

Whole genome sequencing in clinical and public health microbiology.

PubMed

Kwong, J C; McCallum, N; Sintchenko, V; Howden, B P

2015-04-01

Genomics and whole genome sequencing (WGS) have the capacity to greatly enhance knowledge and understanding of infectious diseases and clinical microbiology.The growth and availability of bench-top WGS analysers has facilitated the feasibility of genomics in clinical and public health microbiology.Given current resource and infrastructure limitations, WGS is most applicable to use in public health laboratories, reference laboratories, and hospital infection control-affiliated laboratories.As WGS represents the pinnacle for strain characterisation and epidemiological analyses, it is likely to replace traditional typing methods, resistance gene detection and other sequence-based investigations (e.g., 16S rDNA PCR) in the near future.Although genomic technologies are rapidly evolving, widespread implementation in clinical and public health microbiology laboratories is limited by the need for effective semi-automated pipelines, standardised quality control and data interpretation, bioinformatics expertise, and infrastructure.

Detection of Practice Pattern Trends through Natural Language Processing of Clinical Narratives and Biomedical Literature

PubMed Central

Chen, Elizabeth S.; Stetson, Peter D.; Lussier, Yves A.; Markatou, Marianthi; Hripcsak, George; Friedman, Carol

2007-01-01

Clinical knowledge, best evidence, and practice patterns evolve over time. The ability to track these changes and study practice trends may be valuable for performance measurement and quality improvement efforts. The goal of this study was to assess the feasibility and validity of methods to generate and compare trends in biomedical literature and clinical narrative. We focused on the challenge of detecting trends in medication usage over time for two diseases: HIV/AIDS and asthma. Information about disease-specific medications in published randomized control trials and discharge summaries at New York-Presbyterian Hospital over a ten-year period were extracted using Natural Language Processing. This paper reports on the ability of our semi-automated process to discover disease-drug practice pattern trends and interpretation of findings across the biomedical and clinical text sources. PMID:18693810

A geometrically based method for automated radiosurgery planning.

PubMed

Wagner, T H; Yi, T; Meeks, S L; Bova, F J; Brechner, B L; Chen, Y; Buatti, J M; Friedman, W A; Foote, K D; Bouchet, L G

2000-12-01

A geometrically based method of multiple isocenter linear accelerator radiosurgery treatment planning optimization was developed, based on a target's solid shape. Our method uses an edge detection process to determine the optimal sphere packing arrangement with which to cover the planning target. The sphere packing arrangement is converted into a radiosurgery treatment plan by substituting the isocenter locations and collimator sizes for the spheres. This method is demonstrated on a set of 5 irregularly shaped phantom targets, as well as a set of 10 clinical example cases ranging from simple to very complex in planning difficulty. Using a prototype implementation of the method and standard dosimetric radiosurgery treatment planning tools, feasible treatment plans were developed for each target. The treatment plans generated for the phantom targets showed excellent dose conformity and acceptable dose homogeneity within the target volume. The algorithm was able to generate a radiosurgery plan conforming to the Radiation Therapy Oncology Group (RTOG) guidelines on radiosurgery for every clinical and phantom target examined. This automated planning method can serve as a valuable tool to assist treatment planners in rapidly and consistently designing conformal multiple isocenter radiosurgery treatment plans.

Identifying Early Dehydration Risk With Home-Based Sensors During Radiation Treatment: A Feasibility Study on Patients With Head and Neck Cancer

PubMed Central

2013-01-01

Background Systems that enable remote monitoring of patients’ symptoms and other health-related outcomes may optimize cancer care outside of the clinic setting. CYCORE (CYberinfrastructure for COmparative effectiveness REsearch) is a software-based prototype for a user-friendly cyberinfrastructure supporting the comprehensive collection and analyses of data from multiple domains using a suite of home-based and mobile sensors. This study evaluated the feasibility of using CYCORE to address early at-home identification of dehydration risk in head and neck cancer patients undergoing radiation therapy. Methods Head and neck cancer patients used home-based sensors to capture weight, blood pressure, pulse, and patient-reported outcomes for two 5-day periods during radiation therapy. Data were sent to the radiation oncologist of each head and neck cancer patient, who viewed them online via a Web-based interface. Feasibility outcomes included study completion rate, acceptability and perceived usefulness of the intervention, and adherence to the monitoring protocol. We also evaluated whether sensor data could identify dehydration-related events. Results Fifty patients consented to participate, and 48 (96%) completed the study. More than 90% of patients rated their ease, self-efficacy, and satisfaction regarding use of the sensor suite as extremely favorable, with minimal concerns expressed regarding data privacy issues. Patients highly valued the ability to have immediate access to objective, self-monitoring data related to personal risk for dehydration. Clinician assessments indicated a high degree of satisfaction with the ease of using the CYCORE system and the resulting ability to monitor their patients remotely. Conclusion Implementing CYCORE in a clinical oncology care setting is feasible and highly acceptable to both patients and providers. PMID:24395986

Safer Prescribing and Care for the Elderly (SPACE): feasibility of audit and feedback plus practice mail-out to patients with high-risk prescribing.

PubMed

Wallis, Katharine; Tuckey, Rebecca

2017-06-01

INTRODUCTION High-risk prescribing in general practice is common and places patients at increased risk of adverse events. AIM The Safer Prescribing and Care for the Elderly (SPACE) intervention, comprising audit and feedback plus practice mail-out to patients with high-risk prescribing, was designed to promote medicines review and support safer prescribing. This study aims to test the SPACE intervention feasibility in general practice. METHODS This feasibility study involved an Auckland Primary Health Organisation (PHO), a clinical advisory pharmacist, two purposively sampled urban general practices, and seven GPs. The acceptability and utility of the SPACE intervention were assessed by semi- structured interviews involving study participants, including 11 patients with high-risk prescribing. Interviews were audio-recorded, transcribed verbatim and analysed using a general inductive approach to identify emergent themes. RESULTS The pharmacist said the SPACE intervention facilitated communication with GPs, and provided a platform for their clinical advisory role at no extra cost to the PHO. GPs said the feedback session with the pharmacist was educational but added to time pressures. GPs selected 29 patients for the mail-out. Some GPs were concerned the mail-out might upset patients, but patients said they felt cared for. Some patients intended to take the letter to their next appointment and discuss their medicines with their GP; others said there were already many things to discuss and not enough time. Some patients were confused by the medicines information brochure. DISCUSSION The SPACE intervention is feasible in general practice. The medicines information brochure needs simplification. Further research is needed to test the effect of SPACE on high-risk prescribing.

Sleep problems in university students – an intervention

PubMed Central

Schlarb, Angelika Anita; Friedrich, Anja; Claßen, Merle

2017-01-01

Introduction Up to 60% of all college students suffer from a poor sleep quality, and 7.7% meet all criteria of an insomnia disorder. Sleep problems have a great impact on the students’ daily life, for example, the grade point average. Due to irregular daytime routines, chronotype changes, side jobs and exam periods, they need specialized treatments for improving sleep. “Studieren wie im Schlaf” (SWIS; (studying in your sleep)) is a multicomponent sleep training that combines Cognitive Behavioral Therapy for Insomnia and Hypnotherapy for Insomnia to improve students’ sleep, insomnia symptoms and nightmares. The aim of the present study is to evaluate the acceptance, feasibility and the first effects of SWIS. Methods Twenty-seven students (mean =24.24, standard deviation =3.57) participated in a study of pre–post design. The acceptance and feasibility were measured with questionnaires. In addition, the Pittsburgh Sleep Quality Index (PSQI), sleep logs and actigraphy were implemented. Further variables encompassed daytime sleepiness, sleep-related personality traits and cognitions about sleep. Results Seventy-four percent of the participants reported symptoms of an insomnia disorder, and 51.9% fulfilled all criteria of an insomnia disorder according to the Diagnostic and Statistical Manual of Mental Disorders (fifth edition). Correspondingly, the students suffered from clinically relevant sleep problems according to the PSQI. The SWIS sleep training is a well-accepted and feasible program. Significant improvements were observed in the subjective sleep quality and sleep-related personality traits, as well as clinical improvements in objective sleep measures. Discussion Findings showed that SWIS is a feasible program for the treatment of sleep problems in college and university students due to its various effects on sleep and cognitive outcomes. Further evaluation of follow-up measurements and additional variables, that is, cognitive performance and mental health, is needed. PMID:28794633

A new efficient method to monitor precocious puberty nationwide in France.

PubMed

Rigou, Annabel; Le Moal, Joëlle; Léger, Juliane; Le Tertre, Alain; Carel, Jean-Claude

2018-02-01

Clinical precocious puberty (PP) is a disease, reputed to be on the increase and suspected to be linked to endocrine disrupting chemicals (EDC) exposure. Population-based epidemiological data are lacking in France and scarce elsewhere. We accessed the feasibility of monitoring PP nationwide in France in this context, using a nationwide existing database, the French National Health Insurance Information System. Here, we present the method we used with a step-by-step approach to build and select the most suitable indicator. We built three indicators reflecting the incidence of idiopathic central precocious puberty (ICPP), the most frequent form of PP, and we compared these indicators according to their strengths and weaknesses with respect to surveillance purposes. Monitoring ICPP in France proved feasible using a Drug reimbursement indicator. Our method is cost efficient and highly relevant in public health surveillance. Our step-by-step approach proved helpful to achieve this project and could be proposed for assessing the feasibility of monitoring health outcomes of interest using existing data bases. What is known: • Precocious puberty (PP) is suspected to be related to EDC exposure and it is believed to be on the increase in France and in others countries. • Very few epidemiologic data on PP are currently available in the world at the national scale. What is new: • This is the first study describing a method to monitor the most frequent form of PP, idiopathic central PP (ICPP) nationwide in a cost-efficient way, using health insurance databases. • This cost-effective method will allow to estimate and monitor the incidence of ICPP in France and to analyze spatial variations at a very precise scale, which will be very useful to examine the role of environmental exposures, especially to EDCs.

Assessing Option Grid® practicability and feasibility for facilitating shared decision making: An exploratory study.

PubMed

Tsulukidze, Maka; Grande, Stuart W; Gionfriddo, Michael R

2015-07-01

To assess the feasibility of Option Grids(®)for facilitating shared decision making (SDM) in simulated clinical consultations and explore clinicians' views on their practicability. We used mixed methods approach to analyze clinical consultations using the Observer OPTION instrument and thematic analysis for follow-up interviews with clinicians. Clinicians achieved high scores on information sharing and low scores on preference elicitation and integration. Four themes were identified: (1) Barriers affect practicability of Option Grids(®); (2) Option Grids(®) facilitate the SDM process; (3) Clinicians are aware of the gaps in their practice of SDM; (4) Training and ongoing feedback on the optimal use of Option Grids(®) are necessary. Use of Option Grids(®) by clinicians with background knowledge in SDM did not facilitate optimal levels of competency on the SDM core concepts of preference elicitation and integration. Future research must evaluate the impact of training on the use of Option Grids(®), and explore how best to help clinicians bridge the gap between knowledge and action. Clinicians proficiently imparting information in simulations struggled to elicit and integrate patient preferences - understanding this gap and developing strategies to close it are the next steps for implementing SDM into clinical practice. Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.

Children and their parents assessing the doctor-patient interaction: a rating system for doctors' communication skills.

PubMed

Crossley, Jim; Eiser, Christine; Davies, Helena A

2005-08-01

Only a patient and his or her family can judge many of the most important aspects of the doctor-patient interaction. This study evaluates the feasibility and reliability of children and their families assessing the quality of paediatricians' interactions using a rating instrument developed specifically for this purpose. A reliability analysis using generalisability theory on the ratings from 352 doctor-patient interactions across different speciality clinics. Ratings were normally distributed. They were highest for 'overall' performance, and lowest for giving time to discuss the families' agenda. An appropriate sample of adults' ratings provided a reliable score (G = 0.7 with 15 raters), but children's ratings were too idiosyncratic to be reproducible (G = 0.36 with 15 raters). CONCLUSIONS AND FURTHER WORK: Accompanying adults can provide reliable ratings of doctors' interactions with children. Because an adult is usually present at the consultation their ratings provide a highly feasible and authentic approach. Sampling doctors' interactions from different clinics and with patients of both genders provides a universal picture of performance. The method is ideal to measure performance for in-training assessment or revalidation. Further work is in progress to evaluate the educational impact of feeding ratings back to the doctors being assessed, and their use in a range of clinical contexts.

SU-F-T-440: The Feasibility Research of Checking Cervical Cancer IMRT Pre- Treatment Dose Verification by Automated Treatment Planning Verification System

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

Liu, X; Yin, Y; Lin, X

Purpose: To assess the preliminary feasibility of automated treatment planning verification system in cervical cancer IMRT pre-treatment dose verification. Methods: The study selected randomly clinical IMRT treatment planning data for twenty patients with cervical cancer, all IMRT plans were divided into 7 fields to meet the dosimetric goals using a commercial treatment planning system(PianncleVersion 9.2and the EclipseVersion 13.5). The plans were exported to the Mobius 3D (M3D)server percentage differences of volume of a region of interest (ROI) and dose calculation of target region and organ at risk were evaluated, in order to validate the accuracy automated treatment planning verification system.more » Results: The difference of volume for Pinnacle to M3D was less than results for Eclipse to M3D in ROI, the biggest difference was 0.22± 0.69%, 3.5±1.89% for Pinnacle and Eclipse respectively. M3D showed slightly better agreement in dose of target and organ at risk compared with TPS. But after recalculating plans by M3D, dose difference for Pinnacle was less than Eclipse on average, results were within 3%. Conclusion: The method of utilizing the automated treatment planning system to validate the accuracy of plans is convenientbut the scope of differences still need more clinical patient cases to determine. At present, it should be used as a secondary check tool to improve safety in the clinical treatment planning.« less

Mobile, real-time, and point-of-care augmented reality is robust, accurate, and feasible: a prospective pilot study.

PubMed

Kenngott, Hannes Götz; Preukschas, Anas Amin; Wagner, Martin; Nickel, Felix; Müller, Michael; Bellemann, Nadine; Stock, Christian; Fangerau, Markus; Radeleff, Boris; Kauczor, Hans-Ulrich; Meinzer, Hans-Peter; Maier-Hein, Lena; Müller-Stich, Beat Peter

2018-06-01

Augmented reality (AR) systems are currently being explored by a broad spectrum of industries, mainly for improving point-of-care access to data and images. Especially in surgery and especially for timely decisions in emergency cases, a fast and comprehensive access to images at the patient bedside is mandatory. Currently, imaging data are accessed at a distance from the patient both in time and space, i.e., at a specific workstation. Mobile technology and 3-dimensional (3D) visualization of radiological imaging data promise to overcome these restrictions by making bedside AR feasible. In this project, AR was realized in a surgical setting by fusing a 3D-representation of structures of interest with live camera images on a tablet computer using marker-based registration. The intent of this study was to focus on a thorough evaluation of AR. Feasibility, robustness, and accuracy were thus evaluated consecutively in a phantom model and a porcine model. Additionally feasibility was evaluated in one male volunteer. In the phantom model (n = 10), AR visualization was feasible in 84% of the visualization space with high accuracy (mean reprojection error ± standard deviation (SD): 2.8 ± 2.7 mm; 95th percentile = 6.7 mm). In a porcine model (n = 5), AR visualization was feasible in 79% with high accuracy (mean reprojection error ± SD: 3.5 ± 3.0 mm; 95th percentile = 9.5 mm). Furthermore, AR was successfully used and proved feasible within a male volunteer. Mobile, real-time, and point-of-care AR for clinical purposes proved feasible, robust, and accurate in the phantom, animal, and single-trial human model shown in this study. Consequently, AR following similar implementation proved robust and accurate enough to be evaluated in clinical trials assessing accuracy, robustness in clinical reality, as well as integration into the clinical workflow. If these further studies prove successful, AR might revolutionize data access at patient bedside.

Important considerations for feasibility studies in physical activity research involving persons with multiple sclerosis: a scoping systematic review and case study.

PubMed

Learmonth, Yvonne C; Motl, Robert W

2018-01-01

Much research has been undertaken to establish the important benefits of physical activity in persons with multiple sclerosis (MS). There is disagreement regarding the strength of this research, perhaps because the majority of studies on physical activity and its benefits have not undergone initial and systematic feasibility testing. We aim to address the feasibility processes that have been examined within the context of physical activity interventions in MS. A systematic scoping review was conducted based on a literature search of five databases to identify feasibility processes described in preliminary studies of physical activity in MS. We read and extracted methodology from each study based on the following feasibility metrics: process (e.g. recruitment), resource (e.g. monetary costs), management (e.g. personnel time requirements) and scientific outcomes (e.g. clinical/participant reported outcome measures). We illustrate the use of the four feasibility metrics within a randomised controlled trial of a home-based exercise intervention in persons with MS. Twenty-five studies were identified. Resource feasibility (e.g. time and resources) and scientific outcomes feasibility (e.g. clinical outcomes) methodologies were applied and described in many studies; however, these metrics have not been systematically addressed. Metrics related to process feasibility (e.g. recruitment) and management feasibility (e.g. human and data management) are not well described within the literature. Our case study successfully enabled us to address the four feasibility metrics, and we provide new information on management feasibility (i.e. estimate data completeness and estimate data entry) and scientific outcomes feasibility (i.e. determining data collection materials appropriateness). Our review highlights the existing research and provides a case study which assesses important metrics of study feasibility. This review serves as a clarion call for feasibility trials that will substantially strengthen the foundation of research on exercise in MS.

Clinical application of laser treatment for cardiovascular surgery

PubMed Central

Okada, Masayoshi; Yoshida, Masato; Tsuji, Yoshihiko; Horii, Hiroyuki

2011-01-01

Background: Recently, several kinds of lasers have been widely employed in the field of medicine and surgery. However, laser applications are very rare in the field of cardiovascular surgery throughout the world. So, we have experimentally tried to use lasers in the field of cardiovascular surgery. There were three categories: 1) Transmyocardial laser revascularization (TMLR), 2) Laser vascular anastomosis, and 3) Laser angioplasty in the peripheral arterial diseases. By the way, surgery for ischemic heart disease has been widely performed in Japan. Especially coronary artery bypass grafting (CABG) for these patients has been done as a popular surgical method. Among these patients there are a few cases for whom CABG and percutaneous coronary intervention (PCI) could not be carried out, because of diffuse stenosis and small caliber of coronary arteries. Materials and methods of TMLR: A new method of tranasmyocardial revascularization by CO2 laser (output 100 W, irradiation time 0.2 sec) was experimentally performed to save severely ill patients. In this study, a feasibility of transmyocardial laser revascularization from left ventricular cavity through artificially created channels by laser was precisely evaluated. Results: In trials on dogs laser holes 0.2mm in diameter have been shown microscopically to be patent even 3 years after their creation, thus this procedure could be used as a new method of transmyocardial laser revascularization. Clinical application of TMLR: Subsequently, transmyocardial laser revascularization was employed in a 55-year-old male patient with severe angina pectoris who had undergone pericardiectomy 7 years before. He was completely recovered from severe chest pain. Conclusions of TMLR: This patient was the first successful case in the world with TMLR alone. This method might be done for the patients who percutaneous coronary intervention and coronary artery bypass grafting could be carried out. Laser vascular anastomosis: At present time, in vascular surgery there are some problems to keep long-term patency after anastomosis of the conventional suture method, especially for small-caliber vessels. Materials and methods of Laser vascular anastomosis: From these standpoints, a low energy CO2 laser was employed experimentally in vascular anastomosis for small-caliber vessels. Resullts of Laser vascular anastomosis: From preliminary experiments it could be concluded that the optimal laser output was 20–40 mW and irradiation time was 6–12 sec/mm for vascular anastomosis of small-caliber vessels in the extremities. And then, histologic findings and intensity of the laser anastomotic sites were investigated thereafter. Subseqently, good enough intensity and good healing of laser anastomotic sites as well as the conventional suture method could be observed. There were no statistic differences between laser and suture methods. A feasibility of laser anastomosis could be considered and clinical application could be recognized. Clinical applications of Laser vascular anastomosis: On February 21, 1985, arterio-venous laser anastomosis for the patient with renal failure was smoothly done and she could accept hemodialysis. Conclusions of Laser vascular anastomosis: This patient was the first clinical successful case in the world. Thereafter, Laser vascular anastomosis were in 111 patients with intermittent claudication, refractory crural ulcer, and coronary disorders. Thereafter, they are going well. Laser angioplasty: Laser angioplasty for peripheral arterial diseases. There are many methods to treat peripheral arterial diseases such as balloon method, atherectomy, laser technique and stenting graft in the field of endovascular treatment. Recent years, minimal invasive treatment should be employed even in the surgical treatment. However, there are different images between these methods. Materials and methods of Laser angioplasty: We have chosen to use laser for endovascular treatment for peripheral arterial diseases. We have tried to check between laser energy and vessel wall. Results of Laser angioplasty: Subsequently, it could be concluded that optimal conditions for laser angioplasty were 6 W in output and irradiation time was 5 sec. And with another method of feedback control system, temperature of metal tip probe was 200°C and irradiation time was 5 sec for each shot. And histological study and feasibility of angioscopic guidance could be done and clinical application was started. Until now, 115 patients were successfully treated with their life longevity. Conclusions of Laser angioplasty: Thus, laser applications were useful methods to treat a lot of patients with some ischemic problems. PMID:24155531

Clinical evaluation of semi-automatic open-source algorithmic software segmentation of the mandibular bone: Practical feasibility and assessment of a new course of action.

PubMed

Wallner, Jürgen; Hochegger, Kerstin; Chen, Xiaojun; Mischak, Irene; Reinbacher, Knut; Pau, Mauro; Zrnc, Tomislav; Schwenzer-Zimmerer, Katja; Zemann, Wolfgang; Schmalstieg, Dieter; Egger, Jan

2018-01-01

Computer assisted technologies based on algorithmic software segmentation are an increasing topic of interest in complex surgical cases. However-due to functional instability, time consuming software processes, personnel resources or licensed-based financial costs many segmentation processes are often outsourced from clinical centers to third parties and the industry. Therefore, the aim of this trial was to assess the practical feasibility of an easy available, functional stable and licensed-free segmentation approach to be used in the clinical practice. In this retrospective, randomized, controlled trail the accuracy and accordance of the open-source based segmentation algorithm GrowCut was assessed through the comparison to the manually generated ground truth of the same anatomy using 10 CT lower jaw data-sets from the clinical routine. Assessment parameters were the segmentation time, the volume, the voxel number, the Dice Score and the Hausdorff distance. Overall semi-automatic GrowCut segmentation times were about one minute. Mean Dice Score values of over 85% and Hausdorff Distances below 33.5 voxel could be achieved between the algorithmic GrowCut-based segmentations and the manual generated ground truth schemes. Statistical differences between the assessment parameters were not significant (p<0.05) and correlation coefficients were close to the value one (r > 0.94) for any of the comparison made between the two groups. Complete functional stable and time saving segmentations with high accuracy and high positive correlation could be performed by the presented interactive open-source based approach. In the cranio-maxillofacial complex the used method could represent an algorithmic alternative for image-based segmentation in the clinical practice for e.g. surgical treatment planning or visualization of postoperative results and offers several advantages. Due to an open-source basis the used method could be further developed by other groups or specialists. Systematic comparisons to other segmentation approaches or with a greater data amount are areas of future works.

Ex vivo water exchange performance and short-term clinical feasibility assessment of newly developed heat and moisture exchangers for pulmonary rehabilitation after total laryngectomy.

PubMed

van den Boer, Cindy; Muller, Sara H; Vincent, Andrew D; Züchner, Klaus; van den Brekel, Michiel W M; Hilgers, Frans J M

2014-02-01

Laryngectomized patients suffer from respiratory complaints due to insufficient warming and humidification of inspired air in the upper respiratory tract. Improvement of pulmonary humidification with significant reduction of pulmonary complaints is achieved by the application of a heat and moisture exchanger (HME) over the tracheostoma. The aim of this study was to determine whether the new Provox HMEs (XM-HME and XF-HME) have a better water exchange performance than their predecessors (R-HME and L-HME, respectively; Atos Medical, Hörby, Sweden). The other aim was to assess the short-term clinical feasibility of these HMEs. The XM-HME and XF-HME were weighed at the end of inspiration and at the end of expiration at different breathing volumes produced by a healthy volunteer. The associations between weight changes, breathing volume and absolute humidity were determined using both linear and non-linear mixed effects models. Study-specific questionnaires and tally sheets were used in the clinical feasibility study. The weight change of the XM-HME is 3.6 mg, this is significantly higher than that of the R-HME (2.0 mg). The weight change of the XF-HME (2.0 mg) was not significantly higher than that of the L-HME (1.8 mg). The absolute humidity values of both XM- and XF-HME were significantly higher than that of their predecessors. The clinical feasibility study did not reveal any practical problems over the course of 3 weeks. The XM-HME has a significantly better water exchange performance than its predecessor (R-HME). Both newly designed HMEs did succeed in the clinical feasibility study.

Feasibility and acceptability of a novel, computerized screening and brief intervention (SBI) for alcohol and sweetened beverage use in pregnancy.

PubMed

Nayak, Madhabika B; Korcha, Rachael A; Kaskutas, Lee A; Kaskustas, Lee A; Avalos, Lyndsay A

2014-11-25

Recommended screening and brief intervention (SBI) for alcohol use during pregnancy is impeded by high patient loads and limited resources in public health settings. We evaluated the feasibility, acceptability and validity of a new self-administered, single-session, bilingual, computerized Screening and Brief Intervention (SBI) program for alcohol and sugar sweetened beverage (SSB) use in pregnancy. We developed and tested the computerized SBI program at a public health clinic with 290 pregnant women. Feasibility, acceptability, and validity measures were included in the program which had several modules, including those on demographics, health and beverage use. Time to complete the program and user experience items were used to determine program feasibility and acceptability. Validity analyses compared proportions of prenatal alcohol use identified by the program versus in-person screening by clinic staff. Most program users (87%, n = 251) completed the entire program; 91% (n = 263) completed the key screening and brief intervention modules. Most users also completed the program in ten to fifteen minutes. Program users reported that the program was easy to use (97%), they learned something new (88%), and that they would share what they learned with others (83%) and with their doctors or clinic staff (76%). Program acceptability did not differ by age, education, or type of beverage intervention received. The program identified alcohol use in pregnancy among 21% of users, a higher rate than the 13% (p < .01) found via screening by clinic staff. Computerized Screening and Brief Intervention for alcohol and SSB use in public health clinics is feasible and acceptable to English and Spanish speaking pregnant women and can efficiently identify prenatal alcohol use.

Measurement properties, feasibility and clinical utility of the Doloplus-2 pain scale in older adults with cognitive impairment: a systematic review.

PubMed

Rostad, Hanne Marie; Utne, Inger; Grov, Ellen Karine; Puts, Martine; Halvorsrud, Liv

2017-11-02

The Doloplus-2 is a pain assessment scale for assessing pain in older adults with cognitive impairment. It is used in clinical practice and research. However, evidence for its measurement properties, feasibility and clinical utility remain incomplete. This systematic review synthesizes previous research on the measurement properties, feasibility and clinical utility of the scale. We conducted a systematic search in three databases (CINAHL, Medline and PsycINFO) for studies published in English, French, German, Dutch/Flemish or a Scandinavian language between 1990 and April 2017. We also reviewed the Doloplus-2 homepage and reference lists of included studies to supplement our search. Two reviewers independently reviewed titles and abstracts and performed the quality assessment and data abstraction. A total of 24 studies were included in this systematic review. The quality of the studies varied, but many lacked sufficient detail about the samples and response rates. The Doloplus-2 has been studied using diverse samples in a variety of settings; most study participants were in long-term care and in people with dementia. Sixteen studies addressed various aspects of the scale's feasibility and clinical utility, but their results are limited and inconsistent across settings and samples. Support for the scale's reliability, validity and responsiveness varied widely across the studies. Generally, the reliability coefficients reached acceptable benchmarks, but the evidence for different aspects of the scale's validity and responsiveness was incomplete. Additional high-quality studies are warranted to determine in which populations of older adults with cognitive impairment the Doloplus-2 is reliable, valid and feasible. The ability of the Doloplus-2 to meaningfully quantify pain, measure treatment response and improve patient outcomes also needs further investigation. PROSPERO reg. no.: CRD42016049697 registered 20. Oct. 2016.

Feasibility of a real-time hand hygiene notification machine learning system in outpatient clinics.

PubMed

Geilleit, R; Hen, Z Q; Chong, C Y; Loh, A P; Pang, N L; Peterson, G M; Ng, K C; Huis, A; de Korne, D F

2018-04-09

Various technologies have been developed to improve hand hygiene (HH) compliance in inpatient settings; however, little is known about the feasibility of machine learning technology for this purpose in outpatient clinics. To assess the effectiveness, user experiences, and costs of implementing a real-time HH notification machine learning system in outpatient clinics. In our mixed methods study, a multi-disciplinary team co-created an infrared guided sensor system to automatically notify clinicians to perform HH just before first patient contact. Notification technology effects were measured by comparing HH compliance at baseline (without notifications) with real-time auditory notifications that continued till HH was performed (intervention I) or notifications lasting 15 s (intervention II). User experiences were collected during daily briefings and semi-structured interviews. Costs of implementation of the system were calculated and compared to the current observational auditing programme. Average baseline HH performance before first patient contact was 53.8%. With real-time auditory notifications that continued till HH was performed, overall HH performance increased to 100% (P < 0.001). With auditory notifications of a maximum duration of 15 s, HH performance was 80.4% (P < 0.001). Users emphasized the relevance of real-time notification and contributed to technical feasibility improvements that were implemented in the prototype. Annual running costs for the machine learning system were estimated to be 46% lower than the observational auditing programme. Machine learning technology that enables real-time HH notification provides a promising cost-effective approach to both improving and monitoring HH, and deserves further development in outpatient settings. Copyright © 2018 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

Rectal forceps biopsy procedure in cystic fibrosis: technical aspects and patients perspective for clinical trials feasibility.

PubMed

Servidoni, Maria F; Sousa, Marisa; Vinagre, Adriana M; Cardoso, Silvia R; Ribeiro, Maria A; Meirelles, Luciana R; de Carvalho, Rita B; Kunzelmann, Karl; Ribeiro, Antônio F; Ribeiro, José D; Amaral, Margarida D

2013-05-20

Measurements of CFTR function in rectal biopsies ex vivo have been used for diagnosis and prognosis of Cystic Fibrosis (CF) disease. Here, we aimed to evaluate this procedure regarding: i) viability of the rectal specimens obtained by biopsy forceps for ex vivo bioelectrical and biochemical laboratory analyses; and ii) overall assessment (comfort, invasiveness, pain, sedation requirement, etc.) of the rectal forceps biopsy procedure from the patients perspective to assess its feasibility as an outcome measure in clinical trials. We compared three bowel preparation solutions (NaCl 0.9%, glycerol 12%, mannitol), and two biopsy forceps (standard and jumbo) in 580 rectal specimens from 132 individuals (CF and non-CF). Assessment of the overall rectal biopsy procedure (obtained by biopsy forceps) by patients was carried out by telephone surveys to 75 individuals who underwent the sigmoidoscopy procedure. Integrity and friability of the tissue specimens correlate with their transepithelial resistance (r = -0.438 and -0.305, respectively) and are influenced by the bowel preparation solution and biopsy forceps used, being NaCl and jumbo forceps the most compatible methods with the electrophysiological analysis. The great majority of the individuals (76%) did not report major discomfort due to the short procedure time (max 15 min) and considered it relatively painless (79%). Importantly, most (88%) accept repeating it at least for one more time and 53% for more than 4 times. Obtaining rectal biopsies with a flexible endoscope and jumbo forceps after bowel preparation with NaCl solution is a safe procedure that can be adopted for both adults and children of any age, yielding viable specimens for CFTR bioelectrical/biochemical analyses. The procedure is well tolerated by patients, demonstrating its feasibility as an outcome measure in clinical trials.

2D–3D radiograph to cone-beam computed tomography (CBCT) registration for C-arm image-guided robotic surgery

PubMed Central

Liu, Wen Pei; Otake, Yoshito; Azizian, Mahdi; Wagner, Oliver J.; Sorger, Jonathan M.; Armand, Mehran; Taylor, Russell H.

2015-01-01

Purpose C-arm radiographs are commonly used for intraoperative image guidance in surgical interventions. Fluoroscopy is a cost-effective real-time modality, although image quality can vary greatly depending on the target anatomy. Cone-beam computed tomography (CBCT) scans are sometimes available, so 2D–3D registration is needed for intra-procedural guidance. C-arm radiographs were registered to CBCT scans and used for 3D localization of peritumor fiducials during a minimally invasive thoracic intervention with a da Vinci Si robot. Methods Intensity-based 2D–3D registration of intraoperative radiographs to CBCT was performed. The feasible range of X-ray projections achievable by a C-arm positioned around a da Vinci Si surgical robot, configured for robotic wedge resection, was determined using phantom models. Experiments were conducted on synthetic phantoms and animals imaged with an OEC 9600 and a Siemens Artis zeego, representing the spectrum of different C-arm systems currently available for clinical use. Results The image guidance workflow was feasible using either an optically tracked OEC 9600 or a Siemens Artis zeego C-arm, resulting in an angular difference of Δθ : ~ 30°. The two C-arm systems provided TREmean ≤ 2.5 mm and TREmean ≤ 2.0 mm, respectively (i.e., comparable to standard clinical intraoperative navigation systems). Conclusions C-arm 3D localization from dual 2D–3D registered radiographs was feasible and applicable for intraoperative image guidance during da Vinci robotic thoracic interventions using the proposed workflow. Tissue deformation and in vivo experiments are required before clinical evaluation of this system. PMID:25503592

Serial personal digital assistant data capture of health-related quality of life: A randomized controlled trial in a prostate cancer clinic

PubMed Central

Matthew, Andrew G; Currie, Kristen L; Irvine, Jane; Ritvo, Paul; Santa Mina, Daniel; Jamnicky, Leah; Nam, Robert; Trachtenberg, John

2007-01-01

Background In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. Methods 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficultly/ease of using PDA). Results Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. Conclusion The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population. PMID:17617906

Feasibility and Acceptability of Implementing Indirect Calorimetry Into Routine Clinical Care of Patients With Spinal Cord Injury

PubMed Central

Mayr, Hannah; Atresh, Sridhar; Kemp, Irene; Simmons, Joshua; Vivanti, Angela; Hickman, Ingrid J.

2016-01-01

Background: In the absence of reliable predictive equations, indirect calorimetry (IC) remains the gold standard for assessing energy requirements after spinal cord injury (SCI), but it is typically confined to a research setting. The purpose of this study is to assess the feasibility and acceptability of implementing IC into routine clinical care in an Australian SCI rehabilitation facility. Methods: Bedside IC (canopy hood) was performed, and patients completed an IC acceptability questionnaire (open-ended; yes/no; 5-point Likert scale). Fasted resting energy expenditure (REE) steady-state criteria were applied to assess data quality, and adherence to a test ≥20 minutes was recorded. Staff were surveyed to assess impact of IC on usual care. Results: Of 35 eligible patients, 9 declined (7 reported claustrophobia). One patient could not be tested before discharge and 25 underwent IC (84% male, injury level C2-L2, AIS A-D). Anxiety prevented one patient from completing IC, while another failed to fast. The remaining 23 patients achieved a steady-state REE (≥5 consecutive minutes with ≤10% coefficient of variation for VO2 and VCO2). Test-retest (n = 5) showed <10% variation in REE. Patients deemed the procedure acceptable, with 88% reporting a willingness to repeat IC. Eighty percent of patients and 90% of staff agreed it was acceptable for IC to be integrated into usual care. Conclusion: This study found that IC is a feasible and acceptable addition to the routine clinical care of patients recovering from SCI and may serve to improve accuracy of nutrition interventions for this patient population. PMID:29339868

TMS-EEG: From basic research to clinical applications

NASA Astrophysics Data System (ADS)

Hernandez-Pavon, Julio C.; Sarvas, Jukka; Ilmoniemi, Risto J.

2014-11-01

Transcranial magnetic stimulation (TMS) combined with electroencephalography (EEG) is a powerful technique for non-invasively studying cortical excitability and connectivity. The combination of TMS and EEG has widely been used to perform basic research and recently has gained importance in different clinical applications. In this paper, we will describe the physical and biological principles of TMS-EEG and different applications in basic research and clinical applications. We will present methods based on independent component analysis (ICA) for studying the TMS-evoked EEG responses. These methods have the capability to remove and suppress large artifacts, making it feasible, for instance, to study language areas with TMS-EEG. We will discuss the different applications and limitations of TMS and TMS-EEG in clinical applications. Potential applications of TMS are presented, for instance in neurosurgical planning, depression and other neurological disorders. Advantages and disadvantages of TMS-EEG and its variants such as repetitive TMS (rTMS) are discussed in comparison to other brain stimulation and neuroimaging techniques. Finally, challenges that researchers face when using this technique will be summarized.

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.

Modeling thrombin generation: plasma composition based approach.

PubMed

Brummel-Ziedins, Kathleen E; Everse, Stephen J; Mann, Kenneth G; Orfeo, Thomas

2014-01-01

Thrombin has multiple functions in blood coagulation and its regulation is central to maintaining the balance between hemorrhage and thrombosis. Empirical and computational methods that capture thrombin generation can provide advancements to current clinical screening of the hemostatic balance at the level of the individual. In any individual, procoagulant and anticoagulant factor levels together act to generate a unique coagulation phenotype (net balance) that is reflective of the sum of its developmental, environmental, genetic, nutritional and pharmacological influences. Defining such thrombin phenotypes may provide a means to track disease progression pre-crisis. In this review we briefly describe thrombin function, methods for assessing thrombin dynamics as a phenotypic marker, computationally derived thrombin phenotypes versus determined clinical phenotypes, the boundaries of normal range thrombin generation using plasma composition based approaches and the feasibility of these approaches for predicting risk.

Linking quality indicators to clinical trials: an automated approach

PubMed Central

Coiera, Enrico; Choong, Miew Keen; Tsafnat, Guy; Hibbert, Peter; Runciman, William B.

2017-01-01

Abstract Objective Quality improvement of health care requires robust measurable indicators to track performance. However identifying which indicators are supported by strong clinical evidence, typically from clinical trials, is often laborious. This study tests a novel method for automatically linking indicators to clinical trial registrations. Design A set of 522 quality of care indicators for 22 common conditions drawn from the CareTrack study were automatically mapped to outcome measures reported in 13 971 trials from ClinicalTrials.gov. Intervention Text mining methods extracted phrases mentioning indicators and outcome phrases, and these were compared using the Levenshtein edit distance ratio to measure similarity. Main Outcome Measure Number of care indicators that mapped to outcome measures in clinical trials. Results While only 13% of the 522 CareTrack indicators were thought to have Level I or II evidence behind them, 353 (68%) could be directly linked to randomized controlled trials. Within these 522, 50 of 70 (71%) Level I and II evidence-based indicators, and 268 of 370 (72%) Level V (consensus-based) indicators could be linked to evidence. Of the indicators known to have evidence behind them, only 5.7% (4 of 70) were mentioned in the trial reports but were missed by our method. Conclusions We automatically linked indicators to clinical trial registrations with high precision. Whilst the majority of quality indicators studied could be directly linked to research evidence, a small portion could not and these require closer scrutiny. It is feasible to support the process of indicator development using automated methods to identify research evidence. PMID:28651340

Quantum Cascade Laser-Based Infrared Microscopy for Label-Free and Automated Cancer Classification in Tissue Sections.

PubMed

Kuepper, Claus; Kallenbach-Thieltges, Angela; Juette, Hendrik; Tannapfel, Andrea; Großerueschkamp, Frederik; Gerwert, Klaus

2018-05-16

A feasibility study using a quantum cascade laser-based infrared microscope for the rapid and label-free classification of colorectal cancer tissues is presented. Infrared imaging is a reliable, robust, automated, and operator-independent tissue classification method that has been used for differential classification of tissue thin sections identifying tumorous regions. However, long acquisition time by the so far used FT-IR-based microscopes hampered the clinical translation of this technique. Here, the used quantum cascade laser-based microscope provides now infrared images for precise tissue classification within few minutes. We analyzed 110 patients with UICC-Stage II and III colorectal cancer, showing 96% sensitivity and 100% specificity of this label-free method as compared to histopathology, the gold standard in routine clinical diagnostics. The main hurdle for the clinical translation of IR-Imaging is overcome now by the short acquisition time for high quality diagnostic images, which is in the same time range as frozen sections by pathologists.

The feasibility of progressive resistance training in women with polycystic ovary syndrome: a pilot randomized controlled trial.

PubMed

Vizza, Lisa; Smith, Caroline A; Swaraj, Soji; Agho, Kingsley; Cheema, Birinder S

2016-01-01

To evaluate the feasibility of executing a randomized controlled trial of progressive resistance training (PRT) in women with polycystic ovary syndrome (PCOS). Women with PCOS were randomized to an experimental (PRT) group or a no-exercise (usual care) control group. The PRT group was prescribed two supervised and two unsupervised (home-based) training sessions per week for 12 weeks. Feasibility outcomes included recruitment and attrition, adherence, adverse events, and completion of assessments. Secondary outcomes, collected pre and post intervention, included a range of pertinent physiological, functional and psychological measures. Fifteen participants were randomised into the PRT group (n = 8) or control group (n = 7); five women (n = 2 in PRT group and n = 3 in control group) withdrew from the study. The most successful recruitment sources were Facebook (40 %) and online advertisement (27 %), while least successful methods were referrals by clinicians, colleagues and flyers. In the PRT group, attendance to supervised sessions was higher (95 %; standard deviation ±6 %) compared to unsupervised sessions (51 %; standard deviation ±28 %). No adverse events were attributed to PRT. Change in menstrual cycle status was not significantly different between groups over time (p = 0.503). However, the PRT group significantly increased body weight (p = 0.01), BMI (p = 0.04), lean mass (p = 0.01), fat-free mass (p = 0.005) and lower body strength (p = 0.03), while reducing waist circumference (p = 0.03) and HbA1c (p = 0.033) versus the control group. The PRT group also significantly improved across several domains of disease-specific and general health-related quality of life, depression, anxiety and exercise self-efficacy. A randomized controlled trial of PRT in PCOS would be feasible, and this mode of exercise may elicit a therapeutic effect on clinically important outcomes in this cohort. The success of a large-scale trial required to confirm these findings would be contingent on addressing the feasibility hurdles identified in this study with respect to recruitment, attrition, compliance, and collection of standardized clinical data. Australia New Zealand Clinical Trials Registry; ACTRN12614000517673 Registered 15 May 2014.

Is a decentralized continuing medical education program feasible for Chinese rural health professionals?

PubMed

Hu, Guijie; Yi, Yanhua

2016-01-01

Rural health professionals in township health centers (THCs) tend to have less advanced educational degrees. This study aimed to ascertain the perceived feasibility of a decentralized continuing medical education (CME) program to upgrade their educational levels. A cross-sectional survey of THC health professionals was conducted using a self-administered, structured questionnaire in Guangxi Zhuang Autonomous Region, China. The health professionals in the THCs were overwhelmingly young with low education levels. They had a strong desire to upgrade their educational degrees. The decentralized CME program was perceived as feasible by health workers with positive attitudes about the benefit for license examination, and by those who intended to improve their clinical diagnosis and treatment skills. The target groups of such a program were those who expected to undertake a bachelor's degree and who rated themselves as "partially capable" in clinical competency. They reported that 160-400 USD annually would be an affordable fee for the program. A decentralized CME program was perceived feasible to upgrade rural health workers' education level to a bachelor's degree and improve their clinical competency.

A YinYang bipolar fuzzy cognitive TOPSIS method to bipolar disorder diagnosis.

PubMed

Han, Ying; Lu, Zhenyu; Du, Zhenguang; Luo, Qi; Chen, Sheng

2018-05-01

Bipolar disorder is often mis-diagnosed as unipolar depression in the clinical diagnosis. The main reason is that, different from other diseases, bipolarity is the norm rather than exception in bipolar disorder diagnosis. YinYang bipolar fuzzy set captures bipolarity and has been successfully used to construct a unified inference mathematical modeling method to bipolar disorder clinical diagnosis. Nevertheless, symptoms and their interrelationships are not considered in the existing method, circumventing its ability to describe complexity of bipolar disorder. Thus, in this paper, a YinYang bipolar fuzzy multi-criteria group decision making method to bipolar disorder clinical diagnosis is developed. Comparing with the existing method, the new one is more comprehensive. The merits of the new method are listed as follows: First of all, multi-criteria group decision making method is introduced into bipolar disorder diagnosis for considering different symptoms and multiple doctors' opinions. Secondly, the discreet diagnosis principle is adopted by the revised TOPSIS method. Last but not the least, YinYang bipolar fuzzy cognitive map is provided for the understanding of interrelations among symptoms. The illustrated case demonstrates the feasibility, validity, and necessity of the theoretical results obtained. Moreover, the comparison analysis demonstrates that the diagnosis result is more accurate, when interrelations about symptoms are considered in the proposed method. In a conclusion, the main contribution of this paper is to provide a comprehensive mathematical approach to improve the accuracy of bipolar disorder clinical diagnosis, in which both bipolarity and complexity are considered. Copyright © 2018 Elsevier B.V. All rights reserved.

TH-AB-201-01: A Feasibility Study of Independent Dose Verification for CyberKnife

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

Sato, A; Noda, T; Keduka, Y

2016-06-15

Purpose: CyberKnife irradiation is composed of tiny-size, multiple and intensity-modulated beams compared to conventional linacs. Few of the publications for Independent dose calculation verification for CyberKnife have been reported. In this study, we evaluated the feasibility of independent dose verification for CyberKnife treatment as Secondary check. Methods: The followings were measured: test plans using some static and single beams, clinical plans in a phantom and using patient’s CT. 75 patient plans were collected from several treatment sites of brain, lung, liver and bone. In the test plans and the phantom plans, a pinpoint ion-chamber measurement was performed to assess dosemore » deviation for a treatment planning system (TPS) and an independent verification program of Simple MU Analysis (SMU). In the clinical plans, dose deviation between the SMU and the TPS was performed. Results: In test plan, the dose deviations were 3.3±4.5%, and 4.1±4.4% for the TPS and the SMU, respectively. In the phantom measurements for the clinical plans, the dose deviations were −0.2±3.6% for the TPS and −2.3±4.8% for the SMU. In the clinical plans using the patient’s CT, the dose deviations were −3.0±2.1% (Mean±1SD). The systematic difference was partially derived from inverse square law and penumbra calculation. Conclusion: The independent dose calculation for CyberKnife shows −3.0±4.2% (Mean±2SD) and our study, the confidence limit was achieved within 5% of the tolerance level from AAPM task group 114 for non-IMRT treatment. Thus, it may be feasible to use independent dose calculation verification for CyberKnife treatment as the secondary check. This research is partially supported by Japan Agency for Medical Research and Development (AMED)« less

Smartphone-Based Endoscope System for Advanced Point-of-Care Diagnostics: Feasibility Study

PubMed Central

Bae, Jung Kweon; Vavilin, Andrey; You, Joon S; Kim, Hyeongeun; Ryu, Seon Young; Jang, Jeong Hun

2017-01-01

Background Endoscopic technique is often applied for the diagnosis of diseases affecting internal organs and image-guidance of surgical procedures. Although the endoscope has become an indispensable tool in the clinic, its utility has been limited to medical offices or operating rooms because of the large size of its ancillary devices. In addition, the basic design and imaging capability of the system have remained relatively unchanged for decades. Objective The objective of this study was to develop a smartphone-based endoscope system capable of advanced endoscopic functionalities in a compact size and at an affordable cost and to demonstrate its feasibility of point-of-care through human subject imaging. Methods We developed and designed to set up a smartphone-based endoscope system, incorporating a portable light source, relay-lens, custom adapter, and homebuilt Android app. We attached three different types of existing rigid or flexible endoscopic probes to our system and captured the endoscopic images using the homebuilt app. Both smartphone-based endoscope system and commercialized clinical endoscope system were utilized to compare the imaging quality and performance. Connecting the head-mounted display (HMD) wirelessly, the smartphone-based endoscope system could superimpose an endoscopic image to real-world view. Results A total of 15 volunteers who were accepted into our study were captured using our smartphone-based endoscope system, as well as the commercialized clinical endoscope system. It was found that the imaging performance of our device had acceptable quality compared with that of the conventional endoscope system in the clinical setting. In addition, images captured from the HMD used in the smartphone-based endoscope system improved eye-hand coordination between the manipulating site and the smartphone screen, which in turn reduced spatial disorientation. Conclusions The performance of our endoscope system was evaluated against a commercial system in routine otolaryngology examinations. We also demonstrated and evaluated the feasibility of conducting endoscopic procedures through a custom HMD. PMID:28751302

The PU-PROM: A patient-reported outcome measure for peptic ulcer disease.

PubMed

Liu, Na; Lv, Jing; Liu, Jinchun; Zhang, Yanbo

2017-12-01

Patient-reported outcome measure (PROM) conceived to enable description of treatment-related effects, from the patient perspective, bring the potential to improve in clinical research, and to provide patients with accurate information. Therefore, the aim of this study was to develop a patient-centred peptic ulcer patient-reported outcome measure (PU-PROM) and evaluate its reliability, validity, differential item functioning (DIF) and feasibility. To develop a conceptual framework and item pool for the PU-PROM, we performed a literature review and consulted other measures created in China and other countries. Beyond that, we interviewed 10 patients with peptic ulcers, and consulted six key experts to ensure that all germane parameters were included. In the first item selection phase, classical test theory and item response theory were used to select and adjust items to shape the preliminary measure completed by 130 patients and 50 controls. In the next phase, the measure was evaluated used the same methods with 492 patients and 124 controls. Finally, we used the same population in the second item reselection to assess the reliability, validity, DIF and feasibility of the final measure. The final peptic ulcer PRO measure comprised four domains (physiology, psychology, society and treatment), with 11 subdomains, and 54 items. The Cronbach's α coefficient of each subdomain for the measure was >0.800. Confirmatory factory analysis indicated that the construct validity fulfilled expectations. Model fit indices, such as RMR, RMSEA, NFI, NNFI, CFI and IFI, showed acceptable fit. The measure showed a good response rate. The peptic ulcer PRO measure had good reliability, validity, DIF and feasibility, and can be used as a clinical research evaluation instrument with patients with peptic ulcers to assess their condition focus on treatment. This measure may also be applied in other health areas, especially in clinical trials of new drugs, and may be helpful in clinical decision making. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

A feasibility study of a new method for electrically producing seizures in man: focal electrically administered seizure therapy [FEAST].

PubMed

Nahas, Ziad; Short, Baron; Burns, Carol; Archer, Melanie; Schmidt, Matthew; Prudic, Joan; Nobler, Mitchell S; Devanand, D P; Fitzsimons, Linda; Lisanby, Sarah H; Payne, Nancy; Perera, Tarique; George, Mark S; Sackeim, Harold A

2013-05-01

Electroconvulsive therapy (ECT) remains the most effective acute treatment for severe major depression, but with significant risk of adverse cognitive effects. Unidirectional electrical stimulation with a novel electrode placement and geometry (Focal Electrically Administered Seizure Therapy (FEAST)) has been proposed as a means to initiate seizures in prefrontal cortex prior to secondary generalization. As such, it may have fewer cognitive side effects than traditional ECT. We report on its first human clinical application. Seventeen unmedicated depressed adults (5 men; 3 bipolar disorder; age 53 ± 16 years) were recruited after being referred for ECT. Open-label FEAST was administered with a modified spECTrum 5000Q device and a traditional ECT dosing regimen until patients clinically responded. Clinical and cognitive assessments were obtained at baseline, and end of course. Time to orientation recovery, a predictor of long-term amnestic effects, was assessed at each treatment. Nonresponders to FEAST were transitioned to conventional ECT. One patient withdrew from the study after a single titration session. After the course of FEAST (median 10 sessions), there was a 46.1 ± 35.5% improvement in Hamilton Rating Scale for Depression (HRSD24) scores compared to baseline (33.1 ± 6.8, 16.8 ± 10.9; P < 0.0001). Eight of 16 patients met response criteria (50% decrease in HRSD24) and 5/16 met remission criteria (HRSD24 ≤ 10). Patients achieved full re-orientation (4 of 5 items) in 5.5 ± 6.4 min (median = 3.6), timed from when their eyes first opened after treatment. In this feasibility study, FEAST produced clinically meaningful antidepressant improvement, with relatively short time to reorientation. Our preliminary work first in primates and now depressed adults demonstrates that FEAST is feasible, safe, well-tolerated and, if efficacy can be optimized, has potential to replace traditional ECT. Copyright © 2013 Elsevier Inc. All rights reserved.

Implementation of Patient-Centered Education for Chronic-Disease Management in Uganda: An Effectiveness Study.

PubMed

Siddharthan, Trishul; Rabin, Tracy; Canavan, Maureen E; Nassali, Faith; Kirchhoff, Phillip; Kalyesubula, Robert; Coca, Steven; Rastegar, Asghar; Knauf, Felix

2016-01-01

The majority of non-communicable disease related deaths occur in low- and middle-income countries. Patient-centered care is an essential component of chronic disease management in high income settings. To examine feasibility of implementation of a validated patient-centered education tool among patients with heart failure in Uganda. Mixed-methods, prospective cohort. A private and public cardiology clinic in Mulago National Referral and Teaching Hospital, Kampala, Uganda. Adults with a primary diagnosis of heart failure. PocketDoktor Educational Booklets with patient-centered health education. The primary outcomes were the change in Patient Activation Measure (PAM-13), as well as the acceptability of the PocketDoktor intervention, and feasibility of implementing patient-centered education in outpatient clinical settings. Secondary outcomes included the change in satisfaction with overall clinical care and doctor-patient communication. A total of 105 participants were enrolled at two different clinics: the Mulago Outpatient Department (public) and the Uganda Heart Institute (private). 93 participants completed follow up at 3 months and were included in analysis. The primary analysis showed improved patient activation measure scores regarding disease-specific knowledge, treatment options and prevention of exacerbations among both groups (mean change 0.94 [SD = 1.01], 1.02 [SD = 1.15], and 0.92 [SD = 0.89] among private paying patients and 1.98 [SD = 0.98], 1.93 [SD = 1.02], and 1.45 [SD = 1.02] among public paying patients, p<0.001 for all values) after exposure to the intervention; this effect was significantly larger among indigent patients. Participants reported that materials were easy to read, that they had improved knowledge of disease, and stated improved communication with physicians. Patient-centered medical education can improve confidence in self-management as well as satisfaction with doctor-patient communication and overall care in Uganda. Our results show that printed booklets are locally appropriate, highly acceptable and feasible to implement in an LMIC outpatient setting across socioeconomic groups.

Kidney volume measurement methods for clinical studies on autosomal dominant polycystic kidney disease

PubMed Central

Sharma, Kanishka; Caroli, Anna; Quach, Le Van; Petzold, Katja; Bozzetto, Michela; Serra, Andreas L.; Remuzzi, Giuseppe; Remuzzi, Andrea

2017-01-01

Background In autosomal dominant polycystic kidney disease (ADPKD), total kidney volume (TKV) is regarded as an important biomarker of disease progression and different methods are available to assess kidney volume. The purpose of this study was to identify the most efficient kidney volume computation method to be used in clinical studies evaluating the effectiveness of treatments on ADPKD progression. Methods and findings We measured single kidney volume (SKV) on two series of MR and CT images from clinical studies on ADPKD (experimental dataset) by two independent operators (expert and beginner), twice, using all of the available methods: polyline manual tracing (reference method), free-hand manual tracing, semi-automatic tracing, Stereology, Mid-slice and Ellipsoid method. Additionally, the expert operator also measured the kidney length. We compared different methods for reproducibility, accuracy, precision, and time required. In addition, we performed a validation study to evaluate the sensitivity of these methods to detect the between-treatment group difference in TKV change over one year, using MR images from a previous clinical study. Reproducibility was higher on CT than MR for all methods, being highest for manual and semiautomatic contouring methods (planimetry). On MR, planimetry showed highest accuracy and precision, while on CT accuracy and precision of both planimetry and Stereology methods were comparable. Mid-slice and Ellipsoid method, as well as kidney length were fast but provided only a rough estimate of kidney volume. The results of the validation study indicated that planimetry and Stereology allow using an importantly lower number of patients to detect changes in kidney volume induced by drug treatment as compared to other methods. Conclusions Planimetry should be preferred over fast and simplified methods for accurately monitoring ADPKD progression and assessing drug treatment effects. Expert operators, especially on MR images, are required for performing reliable estimation of kidney volume. The use of efficient TKV quantification methods considerably reduces the number of patients to enrol in clinical investigations, making them more feasible and significant. PMID:28558028

A novel method for electronic measurement and recording of surgical drain output.

PubMed

van Duren, Bernard Hendrik; van Boxel, Gijsbert Isaac

2017-04-01

Surgical drains are used to collect and measure fluids (e.g. serous fluid, lymph, blood, etc.). The volume of fluid in the container is measured using graded markings on the container and then recorded manually on a "drain chart" allowing for manual rate calculations. This method is dependant on regularly checking the volume of the drain and recording the value accurately; unfortunately, this is often not feasible due to staffing levels and time constraints. This results in inaccurate "drain charts" making clinical decisions based on these figures unreliable. Often the lack of confidence in these measurements leads to delayed drain removal with consequent increased infection risks and potential delayed discharge. Accurate digital measurement of drain content would have a significant impact on clinical care. This paper describes a digital technology to measure volume, making use of a positive terminal at the lowest point of the vessel and negative (sensor) terminals placed at accurate intervals along an axis of the vessel. A proof-of-concept prototype was developed using commercially available electronic components to test the feasibility of a technology for electronic measurement and recording of surgical drain content. In a simulated environment, the proposed technology was shown to be effective and accurate. The proposed electronic drain has a number of advantages over currently used devices in saving time and easing pressure on nursing staff, reduce disturbance of patients, and allows for preset alarms.

Fully Phase-Encoded MRI Near Metallic Implants Using Ultrashort Echo Times and Broadband Excitation

PubMed Central

Wiens, Curtis N.; Artz, Nathan S.; Jang, Hyungseok; McMillan, Alan B.; Koch, Kevin M.; Reeder, Scott B.

2017-01-01

Purpose To develop a fully phase-encoded MRI method for distortion-free imaging near metallic implants, in clinically feasible acquisition times. Theory and Methods An accelerated 3D fully phase-encoded acquisition with broadband excitation and ultrashort echo times is presented, which uses a broadband radiofrequency pulse to excite the entire off-resonance induced by the metallic implant. Furthermore, fully phase-encoded imaging is used to prevent distortions caused by frequency encoding, and to obtain ultrashort echo times for rapidly decaying signal. Results Phantom and in vivo acquisitions were used to describe the relationship among excitation bandwidth, signal loss near metallic implants, and T1 weighting. Shorter radiofrequency pulses captured signal closer to the implant by improving spectral coverage and allowing shorter echo times, whereas longer pulses improved T1 weighting through larger maximum attainable flip angles. Comparisons of fully phase-encoded acquisition with broadband excitation and ultrashort echo times to T1-weighted multi-acquisition with variable resonance image combination selective were performed in phantoms and subjects with metallic knee and hip prostheses. These acquisitions had similar contrast and acquisition efficiency. Conclusions Accelerated fully phase-encoded acquisitions with ultrashort echo times and broadband excitation can generate distortion free images near metallic implants in clinically feasible acquisition times. Magn Reson Med 000:000–000, 2017. PMID:28833407

Near Infrared Spectrometry of Clinically Significant Fatty Acids Using Multicomponent Regression

NASA Astrophysics Data System (ADS)

Kalinin, A. V.; Krasheninnikov, V. N.; Sviridov, A. P.; Titov, V. N.

2016-11-01

We have developed methods for determining the content of clinically important fatty acids (FAs), primarily saturated palmitic acid, monounsaturated oleic acid, and the sum of polyenoic fatty acids (eicosapentaenoic + docosahexaenoic), in oily media (food products and supplements, fish oils) using different types of near infrared (NIR) spectrometers: Fourier-transform, linear photodiode array, and Raman. Based on a calibration method (regression) by means of projections to latent structures, using standard samples of oil and fat mixtures, we have confirmed the feasibility of reliable and selective quantitative analysis of the above-indicated fatty acids. As a result of comparing the calibration models for Fourier-transform spectrometers in different parts of the NIR range (based on different overtones and combinations of fatty acid absorption), we have provided a basis for selection of the spectral range for a portable linear InGaAs-photodiode array spectrometer. In testing the calibrations of a linear InGaAs-photodiode array spectrometer which is a prototype for a portable instrument, for palmitic and oleic acids and also the sum of the polyenoic fatty acids we have achieved a multiple correlation coefficient of 0.89, 0.85, and 0.96 and a standard error of 0.53%, 1.43%, and 0.39% respectively. We have confirmed the feasibility of using Raman spectra to determine the content of the above-indicated fatty acids in media where water is present.

The rationale and design of the Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study.

PubMed

Roberts, Matthew A; Pilmore, Helen L; Ierino, Francesco L; Badve, Sunil V; Cass, Alan; Garg, Amit X; Hawley, Carmel M; Isbel, Nicole M; Krum, Henry; Pascoe, Elaine M; Tonkin, Andrew M; Vergara, Liza A; Perkovic, Vlado

2015-03-01

The Beta-blocker to LOwer CArdiovascular Dialysis Events (BLOCADE) Feasibility Study aims to determine the feasibility of a large-scale randomized controlled trial with clinical endpoints comparing the beta-blocking agent carvedilol with placebo in patients receiving dialysis. The BLOCADE Feasibility Study is a randomized, double-blind, placebo-controlled, parallel group feasibility study comparing the beta-blocking agent carvedilol with placebo. Patients receiving dialysis for ≥3 months and who are aged ≥50 years, or who are ≥18 years and have diabetes or cardiovascular disease, were eligible. The primary outcome was the proportion of participants who complete a 6-week run-in phase in which all participants received carvedilol titrated from 3.125 mg twice daily to 6.25 mg twice daily. Other measures included how many patients are screened, the proportion recruited, the overall recruitment rate, the proportion of participants who remain on study drug for 12 months and the incidence of intra-dialytic hypotension while on randomized treatment. The BLOCADE Feasibility Study commenced recruiting in May 2011 and involves 11 sites in Australia and New Zealand. The BLOCADE Feasibility Study will inform the design of a larger clinical endpoint study to determine whether beta-blocking agents provide benefit to patients receiving dialysis, and define whether such a study is feasible. © 2014 Asian Pacific Society of Nephrology.

Safety and feasibility of breast lesion localization using magnetic seeds (Magseed): a multi-centre, open-label cohort study.

PubMed

Harvey, James R; Lim, Yit; Murphy, John; Howe, Miles; Morris, Julie; Goyal, Amit; Maxwell, Anthony J

2018-06-01

Wire localization has several disadvantages, notably wire migration and difficulty scheduling the procedure close to surgery. Radioactive seed localization overcomes these disadvantages, but implementation is limited due to radiation safety requirements. Magnetic seeds potentially offer the logistical benefits and transcutaneous detection equivalence of a radioactive seed, with easier implementation. This study was designed to evaluate the feasibility and safety of using magnetic seeds for breast lesion localization. A two-centre open-label cohort study to assess the feasibility and safety of magnetic seed (Magseed) localization of breast lesions. Magseeds were placed under radiological guidance into women having total mastectomy surgery. The primary outcome measure was seed migration distance. Secondary outcome measures included accuracy of placement, ease of transcutaneous detection, seed integrity and safety. Twenty-nine Magseeds were placed into the breasts of 28 patients under ultrasound guidance. There was no migration of the seeds between placement and surgery. Twenty-seven seeds were placed directly in the target lesion with the other seeds being 2 and 3 mm away. All seeds were detectable transcutaneously in all breast sizes and at all depths. There were no complications or safety issues. Magnetic seeds are a feasible and safe method of breast lesion localization. They can be accurately placed, demonstrate no migration in this feasibility study and are detectable in all sizes and depths of breast tissue. Now that safety and feasibility have been demonstrated, further clinical studies are required to evaluate the seed's effectiveness in wide local excision surgery.

Effects of virtual rehabilitation versus conventional physical therapy on postural control, gait, and cognition of patients with Parkinson's disease: study protocol for a randomized controlled feasibility trial.

PubMed

Silva, Keyte Guedes; De Freitas, Tatiana Beline; Doná, Flávia; Ganança, Fernando Freitas; Ferraz, Henrique Ballalai; Torriani-Pasin, Camila; Pompeu, José Eduardo

2017-01-01

There is an association among postural instability, gait dysfunction, and cognitive impairment in subjects with Parkinson's disease (PD). Difficulty in dividing attention, response inhibition, and visuospatial attention deficiencies may contribute to the impairment of motor performance during daily activities. There are strong evidences that physical therapy can prevent physical and cognitive decline in individuals with PD. Recently, the European Physiotherapy Guideline (EPG) was developed based on randomized clinical trials about the effectiveness of the physical therapy to improve the functional deficiencies of individuals with PD. The EPG did not include the use of promising new intervention as virtual reality in PD due the lack of studies about its safety, feasibility and effectiveness. Therefore, this study protocol had as objective to evaluate the feasibility, safety and effectiveness of a physical therapy program-based on the European Physiotherapy Guideline (EPG) compared to Kinect-based training on postural control, gait, cognition, and quality of life (QoL) of Individuals with PD. A single-blind, parallel, randomized, controlled feasibility trial will be conducted with a sample of 32 individuals diagnosed with idiopathic PD. Participants will be allocated into control group (CG) and experimental group (EG). The intervention of the CG will be conventional physical therapy, and the intervention of the EG will be a supervised practice of five Kinect games. Both groups will perform 14 sessions of 1 h each one, twice a week over 7 weeks. Process outcomes will be safety, feasibility, adherence, and acceptability. Safety will be assessed by the proportion of participants who experienced intervention-related adverse events or any serious adverse event during the study period. Feasibility will be assessed through the scores of the games recorded in all training sessions. Adherence will be assessed through the participant's attendance. Acceptability will be the motivation of the participants regarding the interventions. Clinical outcomes will be (1) postural control, (2) cognitive function, (3) balance, (4) gait, and (5) QoL. Individuals will be assessed pre- and post-interventions and after 30 days by a blinded evaluator. This protocol will clarify if an intervention based on Kinect games will be feasible, safe, and acceptable for individuals with PD compared to conventional physical therapy. We will verify whether the proposed interventions can improve clinical outcomes as postural control, gait, cognition, and QoL of individuals with PD. Our hypothesis is that both Kinect games and conventional physical therapy will be feasible, safe, and acceptable for individuals with PD and will promote positive clinical effects. The results of this feasibility study will be used to design a future definitive clinical trial. Unique identification number in WHO Trial Registration: U1111-1171-0371. Brazilian Clinical Trial Registration Number RBR-27kqv5, registration date: February, 2016.

HIS-Based Support of Follow-Up Documentation – Concept and Implementation for Clinical Studies

PubMed Central

Herzberg, S.; Fritz, F.; Rahbar, K.; Stegger, L.; Schäfers, M.; Dugas, M.

2011-01-01

Objective Follow-up data must be collected according to the protocol of each clinical study, i.e. at certain time points. Missing follow-up information is a critical problem and may impede or bias the analysis of study data and result in delays. Moreover, additional patient recruitment may be necessary due to incomplete follow-up data. Current electronic data capture (EDC) systems in clinical studies are usually separated from hospital information systems (HIS) and therefore can provide limited functionality to support clinical workflow. In two case studies, we assessed the feasibility of HIS-based support of follow-up documentation. Methods We have developed a data model and a HIS-based workflow to provide follow-up forms according to clinical study protocols. If a follow-up form was due, a database procedure created a follow-up event which was translated by a communication server into an HL7 message and transferred to the import interface of the clinical information system (CIS). This procedure generated the required follow-up form and enqueued a link to it in a work list of the relating study nurses and study physicians, respectively. Results A HIS-based follow-up system automatically generated follow-up forms as defined by a clinical study protocol. These forms were scheduled into work lists of study nurses and study physicians. This system was integrated into the clinical workflow of two clinical studies. In a study from nuclear medicine, each scenario from the test concept according to the protocol of the single photon emission computer tomography/computer tomography (SPECT/CT) study was simulated and each scenario passed the test. For a study in psychiatry, 128 follow-up forms were automatically generated within 27 weeks, on average five forms per week (maximum 12, minimum 1 form per week). Conclusion HIS-based support of follow-up documentation in clinical studies is technically feasible and can support compliance with study protocols. PMID:23616857

Clinical Feasibility of Continuously Monitored Data for Heart Rate, Physical Activity, and Sleeping by Wearable Activity Trackers in Patients with Thyrotoxicosis: Protocol for a Prospective Longitudinal Observational Study

PubMed Central

Lee, Jie-Eun; Lee, Dong Hwa; Oh, Tae Jung; Kim, Kyoung Min; Choi, Sung Hee; Lim, Soo; Park, Young Joo; Park, Do Joon; Jang, Hak Chul

2018-01-01

Background Thyrotoxicosis is a common disease caused by an excess of thyroid hormones. The prevalence of thyrotoxicosis about 2% and 70-90% of thyrotoxicosis cases are caused by Graves' disease, an autoimmune disease, which has a high recurrence rate when treated with antithyroid drugs such as methimazole or propylthiouracil. The clinical symptoms and signs of thyrotoxicosis include palpitation, weight loss, restlessness, and difficulty sleeping. Although these clinical changes in thyrotoxicosis can be detected by currently available wearable activity trackers, there have been few trials of the clinical application of wearable devices in patients with thyrotoxicosis. Objective The aim of this study is to investigate the clinical applicability of wearable device-generated data to the management of thyrotoxicosis. We are analyzing continuously monitored data for heart rate, physical activity, and sleep in patients with thyrotoxicosis during their clinical course after treatment. Methods Thirty thyrotoxic patients and 10 control subjects were enrolled in this study at Seoul National University Bundang Hospital. Heart rate, physical activity, and sleep are being monitored using a Fitbit Charge HR or Fitbit Charge 2. Clinical data including anthropometric measures, thyroid function test, and hyperthyroidism symptom scale are recorded. Results Study enrollment began in December 2016, and the intervention and follow-up phases are ongoing. The results of the data analysis are expected to be available by September 2017. Conclusions This study will provide a foundational feasibility trial of the clinical applications of biosignal measurements to the differential diagnosis, prediction of clinical course, early detection of recurrence, and treatment in patients with thyrotoxicosis. Trial Registration ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2) PMID:29467121

Clinical Neuropathology practice news 1-2014: Pyrosequencing meets clinical and analytical performance criteria for routine testing of MGMT promoter methylation status in glioblastoma

PubMed Central

Preusser, Matthias; Berghoff, Anna S.; Manzl, Claudia; Filipits, Martin; Weinhäusel, Andreas; Pulverer, Walter; Dieckmann, Karin; Widhalm, Georg; Wöhrer, Adelheid; Knosp, Engelbert; Marosi, Christine; Hainfellner, Johannes A.

2014-01-01

Testing of the MGMT promoter methylation status in glioblastoma is relevant for clinical decision making and research applications. Two recent and independent phase III therapy trials confirmed a prognostic and predictive value of the MGMT promoter methylation status in elderly glioblastoma patients. Several methods for MGMT promoter methylation testing have been proposed, but seem to be of limited test reliability. Therefore, and also due to feasibility reasons, translation of MGMT methylation testing into routine use has been protracted so far. Pyrosequencing after prior DNA bisulfite modification has emerged as a reliable, accurate, fast and easy-to-use method for MGMT promoter methylation testing in tumor tissues (including formalin-fixed and paraffin-embedded samples). We performed an intra- and inter-laboratory ring trial which demonstrates a high analytical performance of this technique. Thus, pyrosequencing-based assessment of MGMT promoter methylation status in glioblastoma meets the criteria of high analytical test performance and can be recommended for clinical application, provided that strict quality control is performed. Our article summarizes clinical indications, practical instructions and open issues for MGMT promoter methylation testing in glioblastoma using pyrosequencing. PMID:24359605

SU-F-J-156: The Feasibility of MR-Only IMRT Planning for Prostate Anatomy

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

Vaitheeswaran, R; Sivaramakrishnan, KR; Kumar, Prashant

Purpose: For prostate anatomy, previous investigations have shown that simulated CT (sCT) generated from MR images can be used for accurate dose computation. In this study, we demonstrate the feasibility of MR-only IMRT planning for prostate case. Methods: Regular CT (rCT) and MR images of the same patient were acquired for prostate anatomy. Regions-of-interest (ROIs) i.e. target and risk structures are delineated on the rCT. A simulated CT (sCT) is generated from the MR image using the method described by Schadewaldt N et al. Their work establishes the clinical acceptability of dose calculation results on the sCT when compared tomore » rCT. rCT and sCT are rigidly registered to ensure proper alignment between the two images. rCT and sCT are overlaid on each other and slice-wise visual inspection confirms excellent agreement between the two images. ROIs on the rCT are copied over to sCT. Philips AutoPlanning solution is used for generating treatment plans. The same treatment technique protocol (plan parameters and clinical goals) is used to generate AutoPlan-rCT and AutoPlan-sCT respectively for rCT and and sCT. DVH comparison on ROIs and slice-wise evaluation of dose is performed between AutoPlan-rCT and AutoPlan-sCT. Delivery parameters i.e. beam and corresponding segments from the AutoPlan-sCT are copied over to rCT and dose is computed to get AutoPlan-sCT-on-rCT. Results: Plan evaluation is done based on Dose Volume Histogram (DVH) of ROIs and manual slice-wise inspection of dose distribution. Both AutoPlan-rCT and AutoPlan-sCT provide a clinically acceptable plan. Also, AutoPlan-sCT-on-rCT shows excellent agreement with AutoPlan-sCT. Conclusion: The study demonstrates that it is feasible to do IMRT planning on the simulated CT image obtained from MR image for prostate anatomy. The research is supported by Philips India Ltd.« less

A simplified chair-side remount technique using customized mounting platforms.

PubMed

Chauhan, Mamta Devendrakumar; Dange, Shankar Pandharinath; Khalikar, Arun Narayan; Vaidya, Smita Padmakar

2012-08-01

Correct occlusal relationships are part of the successful prosthetic treatment for edentulous patients. Fabrication of complete dentures comprises of clinical and laboratory procedures that should be executed accurately for achieving success with fabricated dentures. Errors occurring during the clinical and laboratory procedures of a denture may subsequently lead to the occlusal errors in the final prosthesis. These occlusal errors can be corrected in two ways: i) in patient's mouth ii) by recording new centric relation and remounting dentures on an articulator. The latter method is more feasible because the mobility of denture base on the mucosa in oral cavity does not permit the identification of premature contacts in centric occlusion and tooth guided eccentric excursions. This article describes a modest and effective clinical chair-side remount procedure using customized mounting platforms.

A simplified chair-side remount technique using customized mounting platforms

PubMed Central

Dange, Shankar Pandharinath; Khalikar, Arun Narayan; Vaidya, Smita Padmakar

2012-01-01

Correct occlusal relationships are part of the successful prosthetic treatment for edentulous patients. Fabrication of complete dentures comprises of clinical and laboratory procedures that should be executed accurately for achieving success with fabricated dentures. Errors occurring during the clinical and laboratory procedures of a denture may subsequently lead to the occlusal errors in the final prosthesis. These occlusal errors can be corrected in two ways: i) in patient's mouth ii) by recording new centric relation and remounting dentures on an articulator. The latter method is more feasible because the mobility of denture base on the mucosa in oral cavity does not permit the identification of premature contacts in centric occlusion and tooth guided eccentric excursions. This article describes a modest and effective clinical chair-side remount procedure using customized mounting platforms. PMID:22977726

Dosimetric feasibility of real-time MRI-guided proton therapy

PubMed Central

Moteabbed, M.; Schuemann, J.; Paganetti, H.

2014-01-01

Purpose: Magnetic resonance imaging (MRI) is a prime candidate for image-guided radiotherapy. This study was designed to assess the feasibility of real-time MRI-guided proton therapy by quantifying the dosimetric effects induced by the magnetic field in patients’ plans and identifying the associated clinical consequences. Methods: Monte Carlo dose calculation was performed for nine patients of various treatment sites (lung, liver, prostate, brain, skull-base, and spine) and tissue homogeneities, in the presence of 0.5 and 1.5 T magnetic fields. Dose volume histogram (DVH) parameters such as D95, D5, and V20 as well as equivalent uniform dose were compared for the target and organs at risk, before and after applying the magnetic field. The authors further assessed whether the plans affected by clinically relevant dose distortions could be corrected independent of the planning system. Results: By comparing the resulting dose distributions and analyzing the respective DVHs, it was determined that despite the observed lateral beam deflection, for magnetic fields of up to 0.5 T, neither was the target coverage jeopardized nor was the dose to the nearby organs increased in all cases except for prostate. However, for a 1.5 T magnetic field, the dose distortions were more pronounced and of clinical concern in all cases except for spine. In such circumstances, the target was severely underdosed, as indicated by a decrease in D95 of up to 41% of the prescribed dose compared to the nominal situation (no magnetic field). Sites such as liver and spine were less affected due to higher tissue homogeneity, typically smaller beam range, and the choice of beam directions. Simulations revealed that small modifications to certain plan parameters such as beam isocenter (up to 19 mm) and gantry angle (up to 10°) are sufficient to compensate for the magnetic field-induced dose disturbances. The authors’ observations indicate that the degree of required corrections strongly depends on the beam range and direction relative to the magnetic field. This method was also applicable to more heterogeneous scenarios such as skull-base tumors. Conclusions: This study confirmed the dosimetric feasibility of real-time MRI-guided proton therapy and delivering a clinically acceptable dose to patients with various tumor locations within magnetic fields of up to 1.5 T. This work could serve as a guide and encouragement for further efforts toward clinical implementation of hybrid MRI–proton gantry systems. PMID:25370627

Dosimetric feasibility of real-time MRI-guided proton therapy

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

Moteabbed, M., E-mail: mmoteabbed@partners.org; Schuemann, J.; Paganetti, H.

2014-11-01

Purpose: Magnetic resonance imaging (MRI) is a prime candidate for image-guided radiotherapy. This study was designed to assess the feasibility of real-time MRI-guided proton therapy by quantifying the dosimetric effects induced by the magnetic field in patients’ plans and identifying the associated clinical consequences. Methods: Monte Carlo dose calculation was performed for nine patients of various treatment sites (lung, liver, prostate, brain, skull-base, and spine) and tissue homogeneities, in the presence of 0.5 and 1.5 T magnetic fields. Dose volume histogram (DVH) parameters such as D{sub 95}, D{sub 5}, and V{sub 20} as well as equivalent uniform dose were comparedmore » for the target and organs at risk, before and after applying the magnetic field. The authors further assessed whether the plans affected by clinically relevant dose distortions could be corrected independent of the planning system. Results: By comparing the resulting dose distributions and analyzing the respective DVHs, it was determined that despite the observed lateral beam deflection, for magnetic fields of up to 0.5 T, neither was the target coverage jeopardized nor was the dose to the nearby organs increased in all cases except for prostate. However, for a 1.5 T magnetic field, the dose distortions were more pronounced and of clinical concern in all cases except for spine. In such circumstances, the target was severely underdosed, as indicated by a decrease in D{sub 95} of up to 41% of the prescribed dose compared to the nominal situation (no magnetic field). Sites such as liver and spine were less affected due to higher tissue homogeneity, typically smaller beam range, and the choice of beam directions. Simulations revealed that small modifications to certain plan parameters such as beam isocenter (up to 19 mm) and gantry angle (up to 10°) are sufficient to compensate for the magnetic field-induced dose disturbances. The authors’ observations indicate that the degree of required corrections strongly depends on the beam range and direction relative to the magnetic field. This method was also applicable to more heterogeneous scenarios such as skull-base tumors. Conclusions: This study confirmed the dosimetric feasibility of real-time MRI-guided proton therapy and delivering a clinically acceptable dose to patients with various tumor locations within magnetic fields of up to 1.5 T. This work could serve as a guide and encouragement for further efforts toward clinical implementation of hybrid MRI–proton gantry systems.« less

The Digital Drag and Drop Pillbox

PubMed Central

Granger, Bradi B.; Locke, Susan C.; Bowers, Margaret; Sawyer, Tenita; Shang, Howard; Abernethy, Amy P.; Bloomfield, Richard A.; Gilliss, Catherine L.

2017-01-01

Objective: We present the design and feasibility testing for the “Digital Drag and Drop Pillbox” (D-3 Pillbox), a skill-based educational approach that engages patients and providers, measures performance, and generates reports of medication management skills. Methods: A single-cohort convenience sample of patients hospitalized with heart failure was taught pill management skills using a tablet-based D-3 Pillbox. Medication reconciliation was conducted, and aptitude, performance (% completed), accuracy (% correct), and feasibility were measured. Results: The mean age of the sample (n = 25) was 59 (36–89) years, 50% were women, 62% were black, 46% were uninsured, 46% had seventh-grade education or lower, and 31% scored very low for health literacy. However, most reported that the D-3 Pillbox was easy to read (78%), easy to repeat-demonstrate (78%), and comfortable to use (tablet weight) (75%). Accurate medication recognition was achieved by discharge in 98%, but only 25% reported having a “good understanding of my responsibilities.” Conclusions: The D-3 Pillbox is a feasible approach for teaching medication management skills and can be used across clinical settings to reinforce skills and medication list accuracy. PMID:28282304

Feasibility of using an iPod touch device and acceptability of a stigma reduction intervention with HIV-infected women in the Deep South.

PubMed

Relf, Michael V; Silva, Susan G; Williams, Megan Scull; Moore, Elizabeth; Arscott, Joyell; Caiola, Courtney; Barroso, Julie

2015-10-01

As with many infectious diseases throughout history, stigma is a part of the trajectory of the HIV disease process. HIV-related stigma impedes women from being tested for HIV. Once infected, HIV-related stigma hinders women from disclosing their HIV status to sexual partners and health care providers, engaging in medical care, effectively self-managing the disease after infection, and adhering to anti-retroviral therapy. After three decades of the HIV epidemic, no evidenced-based, culturally relevant, gender-specific interventions exist to help women infected with HIV manage the stigma associated with HIV infection. This manuscript reports the feasibility of using an iPod touch device and acceptability of a stigma reduction intervention with HIV-infected women in the Deep South in a mixed-method, randomized clinical trial. Results from the study demonstrate that it is feasible to utilize an iPod touch device to deliver an HIV-related stigma intervention to women. Further, women report that the HIV-related stigma intervention is acceptable and meaningful.

Feasibility of nitric oxide administration by neonatal helmet-CPAP: a bench study.

PubMed

Trevisanuto, Daniele; Doglioni, Nicoletta; Micaglio, Massimo; Zanardo, Vincenzo

2007-09-01

Inhaled nitric oxide (NO) may have a role in the treatment of preterm infants with respiratory failure. We evaluated the feasibility of administering NO therapy by a new continuous positive airway pressure (CPAP) system (neonatal helmet-CPAP). While maintaining a constant total flow of 8, 10, and 12 l.min(-1), NO concentrations were progressively increased to 5, 10, 20, and 40 p.p.m. in the neonatal helmet-CPAP pressure chamber (5 cmH2O). NO, NO2, and O2 concentrations were measured in the pressure chamber and the immediate external environment. In the chamber, NO2 levels remained low (

Portfolio assessment during medical internships: How to obtain a reliable and feasible assessment procedure?

PubMed

Michels, Nele R M; Driessen, Erik W; Muijtjens, Arno M M; Van Gaal, Luc F; Bossaert, Leo L; De Winter, Benedicte Y

2009-12-01

A portfolio is used to mentor and assess students' clinical performance at the workplace. However, students and raters often perceive the portfolio as a time-consuming instrument. In this study, we investigated whether assessment during medical internship by a portfolio can combine reliability and feasibility. The domain-oriented reliability of 61 double-rated portfolios was measured, using a generalisability analysis with portfolio tasks and raters as sources of variation in measuring the performance of a student. We obtained reliability (Phi coefficient) of 0.87 with this internship portfolio containing 15 double-rated tasks. The generalisability analysis showed that an acceptable level of reliability (Phi = 0.80) was maintained when the amount of portfolio tasks was decreased to 13 or 9 using one and two raters, respectively. Our study shows that a portfolio can be a reliable method for the assessment of workplace learning. The possibility of reducing the amount of tasks or raters while maintaining a sufficient level of reliability suggests an increase in feasibility of portfolio use for both students and raters.

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.

Tracking the hyoid bone in videofluoroscopic swallowing studies

NASA Astrophysics Data System (ADS)

Kellen, Patrick M.; Becker, Darci; Reinhardt, Joseph M.; van Daele, Douglas

2008-03-01

Difficulty swallowing, or dysphagia, has become a growing problem. Swallowing complications can lead to malnutrition, dehydration, respiratory infection, and even death. The current gold standard for analyzing and diagnosing dysphagia is the videofluoroscopic barium swallow study. In these studies, a fluoroscope is used to image the patient ingesting barium solutions of different volumes and viscosities. The hyoid bone anchors many key muscles involved in swallowing and plays a key role in the process. Abnormal hyoid bone motion during a swallow can indicate swallowing dysfunction. Currently in clinical settings, hyoid bone motion is assessed qualitatively, which can be subject to intra-rater and inter-rater bias. This paper presents a semi-automatic method for tracking the hyoid bone that makes quantitative analysis feasible. The user defines a template of the hyoid on one frame, and this template is tracked across subsequent frames. The matching phase is optimized by predicting the position of the template based on kinematics. An expert speech pathologist marked the position of the hyoid on each frame of ten studies to serve as the gold standard. Results from performing Bland-Altman analysis at a 95% confidence interval showed a bias of 0.0+/-0.08 pixels in x and -0.08+/-0.09 pixels in y between the manually-defined gold standard and the proposed method. The average Pearson's correlation between the gold standard and the proposed method was 0.987 in x and 0.980 in y. This paper also presents a method for automatically establishing a patient-centric coordinate system for the interpretation of hyoid motion. This coordinate system corrects for upper body patient motion during the study and identifies superior-inferior and anterior-posterior motion components. These tools make the use of quantitative hyoid motion analysis feasible in clinical and research settings.

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.

Peer Coaching Through mHealth Targeting Physical Activity in People With Parkinson Disease: Feasibility Study.

PubMed

Colón-Semenza, Cristina; Latham, Nancy K; Quintiliani, Lisa M; Ellis, Terry D

2018-02-15

Long-term engagement in exercise and physical activity mitigates the progression of disability and increases quality of life in people with Parkinson disease (PD). Despite this, the vast majority of individuals with PD are sedentary. There is a critical need for a feasible, safe, acceptable, and effective method to assist those with PD to engage in active lifestyles. Peer coaching through mobile health (mHealth) may be a viable approach. The purpose of this study was to develop a PD-specific peer coach training program and a remote peer-mentored walking program using mHealth technology with the goal of increasing physical activity in persons with PD. We set out to examine the feasibility, safety, and acceptability of the programs along with preliminary evidence of individual-level changes in walking activity, self-efficacy, and disability in the peer mentees. A peer coach training program and a remote peer-mentored walking program using mHealth was developed and tested in 10 individuals with PD. We matched physically active persons with PD (peer coaches) with sedentary persons with PD (peer mentees), resulting in 5 dyads. Using both Web-based and in-person delivery methods, we trained the peer coaches in basic knowledge of PD, exercise, active listening, and motivational interviewing. Peer coaches and mentees wore FitBit Zip activity trackers and participated in daily walking over 8 weeks. Peer dyads interacted daily via the FitBit friends mobile app and weekly via telephone calls. Feasibility was determined by examining recruitment, participation, and retention rates. Safety was assessed by monitoring adverse events during the study period. Acceptability was assessed via satisfaction surveys. Individual-level changes in physical activity were examined relative to clinically important differences. Four out of the 5 peer pairs used the FitBit activity tracker and friends function without difficulty. A total of 4 of the 5 pairs completed the 8 weekly phone conversations. There were no adverse events over the course of the study. All peer coaches were "satisfied" or "very satisfied" with the training program, and all participants were "satisfied" or "very satisfied" with the peer-mentored walking program. All participants would recommend this program to others with PD. Increases in average steps per day exceeding the clinically important difference occurred in 4 out of the 5 mentees. Remote peer coaching using mHealth is feasible, safe, and acceptable for persons with PD. Peer coaching using mHealth technology may be a viable method to increase physical activity in individuals with PD. Larger controlled trials are necessary to examine the effectiveness of this approach. ©Cristina Colón-Semenza, Nancy K Latham, Lisa M Quintiliani, Terry D Ellis. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 15.02.2018.

Development of a theory-informed implementation intervention to improve the triage, treatment and transfer of stroke patients in emergency departments using the Theoretical Domains Framework (TDF): the T3 Trial.

PubMed

Craig, Louise E; Taylor, Natalie; Grimley, Rohan; Cadilhac, Dominique A; McInnes, Elizabeth; Phillips, Rosemary; Dale, Simeon; O'Connor, Denise; Levi, Chris; Fitzgerald, Mark; Considine, Julie; Grimshaw, Jeremy M; Gerraty, Richard; Cheung, N Wah; Ward, Jeanette; Middleton, Sandy

2017-07-17

Theoretical frameworks and models based on behaviour change theories are increasingly used in the development of implementation interventions. Development of an implementation intervention is often based on the available evidence base and practical issues, i.e. feasibility and acceptability. The aim of this study was to describe the development of an implementation intervention for the T 3 Trial (Triage, Treatment and Transfer of patients with stroke in emergency departments (EDs)) using theory to recommend behaviour change techniques (BCTs) and drawing on the research evidence base and practical issues of feasibility and acceptability. A stepped method for developing complex interventions based on theory, evidence and practical issues was adapted using the following steps: (1) Who needs to do what, differently? (2) Using a theoretical framework, which barriers and enablers need to be addressed? (3) Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? A researcher panel was convened to review the list of BCTs recommended for use and to identify the most feasible and acceptable techniques to adopt. Seventy-six barriers were reported by hospital staff who attended the workshops (step 1: thirteen TDF domains likely to influence the implementation of the T 3 Trial clinical intervention were identified by the researchers; step 2: the researcher panellists then selected one third of the BCTs recommended for use as appropriate for the clinical context of the ED and, using the enabler workshop data, devised enabling strategies for each of the selected BCTs; and step 3: the final implementation intervention consisted of 27 BCTs). The TDF was successfully applied in all steps of developing an implementation intervention for the T 3 Trial clinical intervention. The use of researcher panel opinion was an essential part of the BCT selection process to incorporate both research evidence and expert judgment. It is recommended that this stepped approach (theory, evidence and practical issues of feasibility and acceptability) is used to develop highly reportable implementation interventions. The classifying of BCTs using recognised implementation intervention components will facilitate generalisability and sharing across different conditions and clinical settings.

A Multidisciplinary Clinical Program is Effective in Stabilizing BMI and Reducing Transaminase Levels in Pediatric Patients with NAFLD

PubMed Central

DeVore, Stephanie; Kohli, Rohit; Lake, Kathleen; Nicholas, Lynda; Dietrich, Kim; Balistreri, William F.; Xanthakos, Stavra A.

2013-01-01

Weight loss is an effective treatment for children with non-alcoholic fatty liver disease (NAFLD) but it is very difficult to achieve outside of an intensive weight management program. We hypothesized that one can achieve success in improving NAFLD and weight-related outcomes in a structured and focused multidisciplinary clinical program feasible to implement in a gastroenterology clinic. Methods We prospectively tracked the clinical status of our patients enrolled in a multidisciplinary program of dietary and exercise advice through an Institutional Review Board-approved NAFLD registry. Each patient met with a gastroenterologist and dietician every 3 months for 30 minutes to set individualized goals and monitor progress. Results 108 children have been enrolled in the registry and of the 83 that were eligible for 1 year follow-up and included in the analysis, 39 patients returned, resulting in a 47% follow-up rate. These 39 patients showed statistically significant improvements in mean BMI z-score (−0.1 units, p<0.05), total (−11 mg/dL, p<0.05) and low density lipoprotein cholesterol (−9 mg/dL, p<0.05), and serum alanine aminotransferase (ALT) levels (−36 U/L) and aspartate amino transferase (AST) levels (−22 U/L) levels. Conclusion A clinically feasible multidisciplinary program of every 3 month 30 minute visits to set and monitor nutrition and exercise goals, stabilized mean BMI z-score and significantly improved aminotransferase levels at 1 year follow-up in obese pediatric patients with NAFLD. PMID:23518484

Prioritization in Comparative Effectiveness Research: The CANCERGEN Experience in Cancer Genomics

PubMed Central

Thariani, Rahber; Wong, William; Carlson, Josh J; Garrison, Louis; Ramsey, Scott; Deverka, Patricia A; Esmail, Laura; Rangarao, Sneha; Hoban, Carolyn J; Baker, Laurence H; Veenstra, David L

2012-01-01

Background Systematic approaches to stakeholder-informed research prioritization are a central focus of comparative effectiveness research. Genomic testing in cancer is an ideal area to refine such approaches given rapid innovation and potentially significant impacts on patient outcomes. Objective To develop and pilot-test a stakeholder-informed approach to prioritizing genomic tests for future study in collaboration with the cancer clinical trials consortium SWOG. Methods We conducted a landscape-analysis to identify genomic tests in oncology using a systematic search of published and unpublished studies, and expert consultation. Clinically valid tests suitable for evaluation in a comparative study were presented to an external stakeholder group. Domains to guide the prioritization process were identified with stakeholder input, and stakeholders ranked tests using multiple voting rounds. Results A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy-makers, and community-based oncologists. We identified nine domains for research prioritization with stakeholder feedback: population impact; current standard of care, strength of association; potential clinical benefits, potential clinical harms, economic impacts, evidence of need, trial feasibility, and market factors. The landscape-analysis identified 635 studies; of 9 tests deemed to have sufficient clinical validity, 6 were presented to stakeholders. Two tests in lung cancer (ERCC1 and EGFR) and one test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. Conclusions Use of a diverse stakeholder group to inform research prioritization is feasible in a pragmatic and timely manner. Additional research is needed to optimize search strategies, stakeholder group composition and integration with existing prioritization mechanisms. PMID:22274803

Clinical risk assessment of patients with chronic kidney disease by using clinical data and multivariate models.

PubMed

Chen, Zewei; Zhang, Xin; Zhang, Zhuoyong

2016-12-01

Timely risk assessment of chronic kidney disease (CKD) and proper community-based CKD monitoring are important to prevent patients with potential risk from further kidney injuries. As many symptoms are associated with the progressive development of CKD, evaluating risk of CKD through a set of clinical data of symptoms coupled with multivariate models can be considered as an available method for prevention of CKD and would be useful for community-based CKD monitoring. Three common used multivariate models, i.e., K-nearest neighbor (KNN), support vector machine (SVM), and soft independent modeling of class analogy (SIMCA), were used to evaluate risk of 386 patients based on a series of clinical data taken from UCI machine learning repository. Different types of composite data, in which proportional disturbances were added to simulate measurement deviations caused by environment and instrument noises, were also utilized to evaluate the feasibility and robustness of these models in risk assessment of CKD. For the original data set, three mentioned multivariate models can differentiate patients with CKD and non-CKD with the overall accuracies over 93 %. KNN and SVM have better performances than SIMCA has in this study. For the composite data set, SVM model has the best ability to tolerate noise disturbance and thus are more robust than the other two models. Using clinical data set on symptoms coupled with multivariate models has been proved to be feasible approach for assessment of patient with potential CKD risk. SVM model can be used as useful and robust tool in this study.

A Natural Language Processing-based Model to Automate MRI Brain Protocol Selection and Prioritization.

PubMed

Brown, Andrew D; Marotta, Thomas R

2017-02-01

Incorrect imaging protocol selection can contribute to increased healthcare cost and waste. To help healthcare providers improve the quality and safety of medical imaging services, we developed and evaluated three natural language processing (NLP) models to determine whether NLP techniques could be employed to aid in clinical decision support for protocoling and prioritization of magnetic resonance imaging (MRI) brain examinations. To test the feasibility of using an NLP model to support clinical decision making for MRI brain examinations, we designed three different medical imaging prediction tasks, each with a unique outcome: selecting an examination protocol, evaluating the need for contrast administration, and determining priority. We created three models for each prediction task, each using a different classification algorithm-random forest, support vector machine, or k-nearest neighbor-to predict outcomes based on the narrative clinical indications and demographic data associated with 13,982 MRI brain examinations performed from January 1, 2013 to June 30, 2015. Test datasets were used to calculate the accuracy, sensitivity and specificity, predictive values, and the area under the curve. Our optimal results show an accuracy of 82.9%, 83.0%, and 88.2% for the protocol selection, contrast administration, and prioritization tasks, respectively, demonstrating that predictive algorithms can be used to aid in clinical decision support for examination protocoling. NLP models developed from the narrative clinical information provided by referring clinicians and demographic data are feasible methods to predict the protocol and priority of MRI brain examinations. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

An Algorithm Approach to Determining Smoking Cessation Treatment for Persons Living with HIV/AIDS: Results of a Pilot Trial

PubMed Central

Cropsey, Karen L.; Jardin, Bianca; Burkholder, Greer; Clark, C. Brendan; Raper, James L.; Saag, Michael

2015-01-01

Background Smoking now represents one of the biggest modifiable risk factors for disease and mortality in PLHIV. To produce significant changes in smoking rates among this population, treatments will need to be both acceptable to the larger segment of PLHIV smokers as well as feasible to implement in busy HIV clinics. The purpose of this study was to evaluate the feasibility and effects of a novel proactive algorithm-based intervention in an HIV/AIDS clinic. Methods PLHIV smokers (N =100) were proactively identified via their electronic medical records and were subsequently randomized at baseline to receive a 12-week pharmacotherapy-based algorithm treatment or treatment as usual. Participants were tracked in-person for 12-weeks. Participants provided information on smoking behaviors and associated constructs of cessation at each follow-up session. Results The findings revealed that many smokers reported utilizing prescribed medications when provided with a supply of cessation medication as determined by an algorithm. Compared to smokers receiving treatment as usual, PLHIV smokers prescribed these medications reported more quit attempts and greater reduction in smoking. Proxy measures of cessation readiness (e.g., motivation, self-efficacy) also favored participants receiving algorithm treatment. Conclusions This algorithm-derived treatment produced positive changes across a number of important clinical markers associated with smoking cessation. Given these promising findings coupled with the brief nature of this treatment, the overall pattern of results suggests strong potential for dissemination into clinical settings as well as significant promise for further advancing clinical health outcomes in this population. PMID:26181705

The Functional Fitness MOT Test Battery for Older Adults: Protocol for a Mixed-Method Feasibility Study.

PubMed

de Jong, Lex D; Peters, Andy; Hooper, Julie; Chalmers, Nina; Henderson, Claire; Laventure, Robert Me; Skelton, Dawn A

2016-06-20

Increasing physical activity (PA) brings many health benefits, but engaging people in higher levels of PA after their 60s is not straightforward. The Functional Fitness MOT (FFMOT) is a new approach which aims to raise awareness about the importance of components of fitness (strength, balance, flexibility), highlight benefits of PA, engages older people in health behavior change discussions, and directs them to local activity resources. This battery of tests combined with a brief motivational interview has not been tested in terms of feasibility or effectiveness. To assess whether the FFMOT, provided in a health care setting, is appealing to older patients of a community physiotherapy service and to understand the views and perceptions of the older people undergoing the FFMOT regarding the intervention, as well as the views of the physiotherapy staff delivering the intervention. Secondary aims are to assess the feasibility of carrying out a phase 2 pilot randomized controlled trial of the FFMOT, in the context of a community physiotherapy service, by establishing whether enough patients can be recruited and retained in the study, and enough outcome data can be generated. A mixed-methods feasibility study will be conducted in two physiotherapy outpatient clinics in the United Kingdom. A total of 30 physically inactive, medically stable older adults over the age of 60 will be provided with an individual FFMOT, comprising a set of six standardized, validated, age-appropriate tests aimed at raising awareness of the different components of fitness. The results of these tests will be used to provide the participants with feedback on performance in comparison to sex and age-referenced norms. This will be followed by tailored advice on how to become more active and improve fitness, including advice on local opportunities to be more active. Subsequently, participants will be invited to attend a focus group to discuss barriers and motivators to being more active, health behavior change, and the scope for individuals to improve their PA levels. To inform the design of a future trial, descriptive (eg, recruitment and retention rates), quantitative (Community Healthy Activities Model Program for Seniors; CHAMPS physical activity questionnaire), and qualitative data (focus group discussions, semi-structured staff interviews) will be collected. Recruitment and enrolment for the trial started in September 2015. Follow-up will be completed in June 2016. Results are expected to be available at the end of 2016. Allied health professionals play a key role in encouraging older adults to increase their PA, but with little evidence on how best to do this within their clinical practice. The purpose of this feasibility study is to examine the introduction of a new service: The FFMOT. The views and perceptions of the older people undergoing the FFMOT and relating to its delivery in clinical practice will be explored. Data, which will inform the feasibility of a randomized controlled trial of effectiveness of the FFMOT in promoting improved PA, will be reported. International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN38950042; http://www.isrctn.com/ISRCTN38950042.

Automated measurement of office, home and ambulatory blood pressure in atrial fibrillation.

PubMed

Kollias, Anastasios; Stergiou, George S

2014-01-01

1. Hypertension and atrial fibrillation (AF) often coexist and are strong risk factors for stroke. Current guidelines for blood pressure (BP) measurement in AF recommend repeated measurements using the auscultatory method, whereas the accuracy of the automated devices is regarded as questionable. This review presents the current evidence on the feasibility and accuracy of automated BP measurement in the presence of AF and the potential for automated detection of undiagnosed AF during such measurements. 2. Studies evaluating the use of automated BP monitors in AF are limited and have significant heterogeneity in methodology and protocols. Overall, the oscillometric method is feasible for static (office or home) and ambulatory use and appears to be more accurate for systolic than diastolic BP measurement. 3. Given that systolic hypertension is particularly common and important in the elderly, the automated BP measurement method may be acceptable for self-home and ambulatory monitoring, but not for professional office or clinic measurement. 4. An embedded algorithm for the detection of asymptomatic AF during routine automated BP measurement with high diagnostic accuracy has been developed and appears to be a useful screening tool for elderly hypertensives. © 2013 Wiley Publishing Asia Pty Ltd.

Sinogram restoration in computed tomography with an edge-preserving penalty

PubMed Central

Little, Kevin J.; La Rivière, Patrick J.

2015-01-01

Purpose: With the goal of producing a less computationally intensive alternative to fully iterative penalized-likelihood image reconstruction, our group has explored the use of penalized-likelihood sinogram restoration for transmission tomography. Previously, we have exclusively used a quadratic penalty in our restoration objective function. However, a quadratic penalty does not excel at preserving edges while reducing noise. Here, we derive a restoration update equation for nonquadratic penalties. Additionally, we perform a feasibility study to extend our sinogram restoration method to a helical cone-beam geometry and clinical data. Methods: A restoration update equation for nonquadratic penalties is derived using separable parabolic surrogates (SPS). A method for calculating sinogram degradation coefficients for a helical cone-beam geometry is proposed. Using simulated data, sinogram restorations are performed using both a quadratic penalty and the edge-preserving Huber penalty. After sinogram restoration, Fourier-based analytical methods are used to obtain reconstructions, and resolution-noise trade-offs are investigated. For the fan-beam geometry, a comparison is made to image-domain SPS reconstruction using the Huber penalty. The effects of varying object size and contrast are also investigated. For the helical cone-beam geometry, we investigate the effect of helical pitch (axial movement/rotation). Huber-penalty sinogram restoration is performed on 3D clinical data, and the reconstructed images are compared to those generated with no restoration. Results: We find that by applying the edge-preserving Huber penalty to our sinogram restoration methods, the reconstructed image has a better resolution-noise relationship than an image produced using a quadratic penalty in the sinogram restoration. However, we find that this relatively straightforward approach to edge preservation in the sinogram domain is affected by the physical size of imaged objects in addition to the contrast across the edge. This presents some disadvantages of this method relative to image-domain edge-preserving methods, although the computational burden of the sinogram-domain approach is much lower. For a helical cone-beam geometry, we found applying sinogram restoration in 3D was reasonable and that pitch did not make a significant difference in the general effect of sinogram restoration. The application of Huber-penalty sinogram restoration to clinical data resulted in a reconstruction with less noise while retaining resolution. Conclusions: Sinogram restoration with the Huber penalty is able to provide better resolution-noise performance than restoration with a quadratic penalty. Additionally, sinogram restoration with the Huber penalty is feasible for helical cone-beam CT and can be applied to clinical data. PMID:25735286

Sinogram restoration in computed tomography with an edge-preserving penalty

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

Little, Kevin J., E-mail: little@uchicago.edu; La Rivière, Patrick J.

2015-03-15

Purpose: With the goal of producing a less computationally intensive alternative to fully iterative penalized-likelihood image reconstruction, our group has explored the use of penalized-likelihood sinogram restoration for transmission tomography. Previously, we have exclusively used a quadratic penalty in our restoration objective function. However, a quadratic penalty does not excel at preserving edges while reducing noise. Here, we derive a restoration update equation for nonquadratic penalties. Additionally, we perform a feasibility study to extend our sinogram restoration method to a helical cone-beam geometry and clinical data. Methods: A restoration update equation for nonquadratic penalties is derived using separable parabolic surrogatesmore » (SPS). A method for calculating sinogram degradation coefficients for a helical cone-beam geometry is proposed. Using simulated data, sinogram restorations are performed using both a quadratic penalty and the edge-preserving Huber penalty. After sinogram restoration, Fourier-based analytical methods are used to obtain reconstructions, and resolution-noise trade-offs are investigated. For the fan-beam geometry, a comparison is made to image-domain SPS reconstruction using the Huber penalty. The effects of varying object size and contrast are also investigated. For the helical cone-beam geometry, we investigate the effect of helical pitch (axial movement/rotation). Huber-penalty sinogram restoration is performed on 3D clinical data, and the reconstructed images are compared to those generated with no restoration. Results: We find that by applying the edge-preserving Huber penalty to our sinogram restoration methods, the reconstructed image has a better resolution-noise relationship than an image produced using a quadratic penalty in the sinogram restoration. However, we find that this relatively straightforward approach to edge preservation in the sinogram domain is affected by the physical size of imaged objects in addition to the contrast across the edge. This presents some disadvantages of this method relative to image-domain edge-preserving methods, although the computational burden of the sinogram-domain approach is much lower. For a helical cone-beam geometry, we found applying sinogram restoration in 3D was reasonable and that pitch did not make a significant difference in the general effect of sinogram restoration. The application of Huber-penalty sinogram restoration to clinical data resulted in a reconstruction with less noise while retaining resolution. Conclusions: Sinogram restoration with the Huber penalty is able to provide better resolution-noise performance than restoration with a quadratic penalty. Additionally, sinogram restoration with the Huber penalty is feasible for helical cone-beam CT and can be applied to clinical data.« less

Single incision laparoscopic surgery (SILS) inguinal hernia repair - recent clinical experiences of this novel technique.

PubMed

Yussra, Y; Sutton, P A; Kosai, N R; Razman, J; Mishra, R K; Harunarashid, H; Das, S

2013-01-01

Inguinal hernia remains the most commonly encountered surgical problem. Various methods of repair have been described, and the most suitable one debated. Single port access (SPA) surgery is a rapidly evolving field, and has the advantage of affording 'scarless' surgery. Single incision laparoscopic surgery (SILS) for inguinal hernia repair is seen to be feasible in both total extraperitoneal (TEP) and transabdominal pre-peritoneal (TAPP) approaches. Data and peri-operative information on both of these however are limited. We aimed to review the clinical experience, feasibility and short term complications related to laparoscopic inguinal hernia repair via single port access. A literature search was performed using Google Scholar, Springerlink Library, Highwire Press, Surgical Endoscopy Journal, World Journal of Surgery and Medscape. The following search terms were used: laparoscopic hernia repair, TAPP, TEP, single incision laparoscopic surgery (SILS). Fourteen articles in English language related to SILS inguinal hernia repair were identified. Nine articles were related to TEP repair and the remaining 5 to TAPP. A total of 340 patients were reported within these studies: 294 patients having a TEP repair and 46 a TAPP. Only two cases of recurrence were reported. Various ports have been utilized, including the SILS port, Tri-Port and a custom- made port using conventional laparoscopic instruments. The duration of surgery was 40-100 minutes and the average length of hospital stay was one day. Early outcomes of this novel technique show it to be feasible, safe and with potentially better cosmetic outcome.

A Feasibility Study of Quantifying Longitudinal Brain Changes in Herpes Simplex Virus (HSV) Encephalitis Using Magnetic Resonance Imaging (MRI) and Stereology

PubMed Central

Keller, Simon S.; Das, Kumar; Vidyasagar, Rishma; Parkes, Laura M.; Burnside, Girvan; Griffiths, Michael; Kopelman, Michael; Roberts, Neil; Solomon, Tom

2017-01-01

Objectives To assess whether it is feasible to quantify acute change in temporal lobe volume and total oedema volumes in herpes simplex virus (HSV) encephalitis as a preliminary to a trial of corticosteroid therapy. Methods The study analysed serially acquired magnetic resonance images (MRI), of patients with acute HSV encephalitis who had neuroimaging repeated within four weeks of the first scan. We performed volumetric measurements of the left and right temporal lobes and of cerebral oedema visible on T2 weighted Fluid Attenuated Inversion Recovery (FLAIR) images using stereology in conjunction with point counting. Results Temporal lobe volumes increased on average by 1.6% (standard deviation (SD 11%) in five patients who had not received corticosteroid therapy and decreased in two patients who had received corticosteroids by 8.5%. FLAIR hyperintensity volumes increased by 9% in patients not receiving treatment with corticosteroids and decreased by 29% in the two patients that had received corticosteroids. Conclusions This study has shown it is feasible to quantify acute change in temporal lobe and total oedema volumes in HSV encephalitis and suggests a potential resolution of swelling in response to corticosteroid therapy. These techniques could be used as part of a randomized control trial to investigate the efficacy of corticosteroids for treating HSV encephalitis in conjunction with assessing clinical outcomes and could be of potential value in helping to predict the clinical outcomes of patients with HSV encephalitis. PMID:28125598

Protocol for a pilot, randomised, double-blinded, placebo-controlled trial of prophylactic use of tranexamic acid for preventing postpartum haemorrhage (TAPPH-1)

PubMed Central

Alam, Asim; Bopardikar, Ameya; Au, Shelly; Barrett, Jon; Callum, Jeannie; Kiss, Alex; Choi, Stephen

2017-01-01

Introduction Postpartum haemorrhage (PPH) is the leading cause of maternal morbidity and mortality worldwide. Despite the availability of multiple uterotonic agents, the incidence of PPH continues to rise. Tranexamic acid (TXA) has been shown to be a safe, effective and inexpensive therapeutic option for the treatment of PPH, however, its use prophylactically in mitigating the risk of PPH is unknown. This pragmatic randomised prospective trial assesses the feasibility and safety of administering TXA at the time of delivery for the prevention of PPH. Methods and analysis A pilot pragmatic randomised double-blinded placebo-controlled trial will be performed. 58 singleton parturients at term >32 weeks, undergoing either spontaneous vaginal delivery, or caesarean section will be randomised to receive 1 g of TXA or placebo (0.9% saline) intravenously. The primary outcome assessed will be the feasibility of administrating TXA, along with collecting data regarding safety of drug administration. The groups will also be analysed on efficacy of mitigating the onset of PPH and clinically relevant variables. Demographic, feasibility, safety and clinical endpoints will be summarised and the appropriate measures of central tendency and dispersion will be presented. Ethics and dissemination This protocol was approved by the Sunnybrook Health Sciences Centre Research Ethics Board (number: 418-2016). The results will be disseminated in a peer-reviewed journal and at scientific meetings. Trial registration number NCT03069859; Pre-results. PMID:29025850

Fast Lesion Mapping during HIFU Treatment Using Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) In Vitro and In Vivo

PubMed Central

Han, Yang; Wang, Shutao; Payen, Thomas; Konofagou, Elisa

2017-01-01

The successful clinical application of High Intensity Focused Ultrasound (HIFU) ablation depends on reliable monitoring of the lesion formation. Harmonic Motion Imaging guided Focused Ultrasound (HMIgFUS) is an ultrasound-based elasticity imaging technique, which monitors HIFU ablation based on the stiffness change of the tissue instead of the echo intensity change in conventional B-mode monitoring, rendering it potentially more sensitive to lesion development. Our group has shown that predicting the lesion location based on the radiation force-excited region is feasible during HMIgFUS. In this study, the feasibility of a fast lesion mapping method is explored to directly monitor the lesion map during HIFU. The HMI lesion map was generated by subtracting the reference HMI image from the present HMI peak-to-peak displacement map to be streamed on the computer display. The dimensions of the HMIgFUS lesions were compared against gross pathology. Excellent agreement was found between the lesion depth (r2 = 0.81, slope = 0.90), width (r2 = 0.85, slope = 1.12) and area (r2 = 0.58, slope = 0.75). In vivo feasibility was assessed in a mouse with a pancreatic tumor. These findings demonstrate that HMIgFUS can successfully map thermal lesion and monitor lesion development in real time in vitro and in vivo. The HMIgFUS technique may therefore constitute a novel clinical tool for HIFU treatment monitoring. PMID:28323638

Integrated Knowledge Translation: illustrated with outcome research in mental health.

PubMed

Preyde, Michele; Carter, Jeff; Penney, Randy; Lazure, Kelly; Vanderkooy, John; Chevalier, Pat

2015-01-01

Through this article the authors present a case summary of the early phases of research conducted with an Integrated Knowledge Translation (iKT) approach utilizing four factors: research question, research approach, feasibility, and outcome. iKT refers to an approach for conducting research in which community partners, referred to as knowledge users, are engaged in the entire research process. In this collaborative approach, knowledge users and researchers jointly devise the entire research agenda beginning with the development of the research question(s), determination of a feasible research design and feasible methods, interpretation of the results, dissemination of the findings, and the translation of knowledge into practice or policy decisions. Engaging clinical or community partners in the research enterprise can enhance the utility of the research results and facilitate its uptake. This collaboration can be a complex arrangement and flexibility may be required to accommodate the various configurations that the collaboration can take. For example, the research question can be jointly determined and refined; however, one person must take the responsibility for orchestrating the project, including preparing the proposal and application to the Research Ethics Board. This collaborative effort also requires the simultaneous navigation of barriers and facilitators to the research enterprise. Navigating these elements becomes part of the conduct of research with the potential for rewarding results, including an enriched work experience for clinical partners and investigators. One practice implication is that iKT may be considered of great utility to service providers due to its field friendly nature.

Assessing the Feasibility of a Social Media to Promote Weight Management Engagement in Adolescents with Severe Obesity: Pilot Study

PubMed Central

Moore, Reneé H; Li, Ziyi; Bishop-Gilyard, Chanelle T; Garrett, Andrew R; Hill, Douglas L; Bruton, Yasmeen P; Sarwer, David B

2018-01-01

Background Severe obesity in adolescents has deleterious physical and psychological complications necessitating frequent multi-disciplinary clinic visits. Greater treatment engagement has been equated with weight-loss. However, traditional medical weight-loss programs for adolescents have high attrition rates. Social media is widely used by adolescents and may enhance medical weight management engagement and success. Objective The first objective was to examine the acceptability and feasibility of using a private social media group as an adjunct to medical weight management in youth ages 14 to 20 years with severe obesity [body mass index (BMI) ≥ 35 kg/m2]. The second objective was to pilot test the use of social media to improve treatment engagement and decrease attrition rates. Methods In this single arm, 12 week pre-post study, participants attended individual clinic visits and participated in a moderated private social media group that received nutrition, exercise, and behavior change social media communications or “posts” 3 to 4 times/week. Youth commented and/or liked posts from the moderator and each other. Social media engagement was measured with the number of likes and comments on social media. Clinic attrition was compared, measuring clinic visit attendance 12 weeks prior, during, and after the intervention with mixed linear regression models. Correlations of social media engagement with changes from baseline for BMI, BMI-z score, and psychosocial measures were fit. Results All 13 enrolled youth completed the study and reported that the group was enjoyable, helpful, reinforced their weight management program, and would recommend using social media to support other youth. The pilot trial was acceptable and feasible. Youth mean weekly engagement (likes + comments) in social media was greater than once a day (8.6 ±3.6). Compared to 12 weeks prior to the intervention, there was no significant decrease in clinic visit attendance at the end of the intervention (M=.231, P=.69) or 12 weeks at the conclusion of the intervention (M=.589, P=.28). Increased social media comments correlated with weight change (r=–.633, P=.04). Conclusions This pilot trial demonstrated that the use of social media as an adjunct to medical weight management was feasible and acceptable to adolescents with severe obesity. Based upon these preliminary findings, social media may be an effective way to mitigate attrition from obesity treatment programs, and improve health outcomes in this high-risk population. PMID:29555623

Feasibility and diagnostic accuracy of early mood screening to diagnose persisting clinical depression/anxiety disorder after stroke.

PubMed

Lees, Rosalind; Stott, David J; Quinn, Terence J; Broomfield, Niall M

2014-01-01

Depression/anxiety disorders are common after stroke and have a negative impact on outcomes. Guidelines recommend that all stroke survivors are screened for these problems. However, there is no consensus on timing or method of assessment. We investigated the feasibility and accuracy of a very early screening strategy and the diagnostic accuracy this has for depression/anxiety disorders at 1 month. Screening tools were Hospital Anxiety and Depression Scale (HADS) and Depression Intensity Scale Circles (DISCs); we also assessed cognition using the Montreal Cognitive Assessment (MoCA). Screening was offered to sequential stroke admissions. At 1 month we assessed for clinical depression/anxiety disorder using Mini-International Neuropsychiatric Interview (MINI) and retested screening tools. We described test accuracy of acute depression/anxiety screening for clinical diagnosis of depression/anxiety disorder at 1 month and described temporal change in screening test scores. We assessed feasibility by describing proportions that were able, agreed to and completed the screening tests. Over 4 months, 102/146 admissions were suitable for screening following initial medical assessment, 69 (68%) agreed to screening, of whom 33 (48%) required researcher assistance to complete the screening test battery. Median time to assessment was 2 days (IQR: 1-4). Early HADS suggested n = 9 (13%) with depression; DISCs n = 25 (37%). Median acute MoCA was 21/30. At 1 month, n = 61 (88%) provided data. Repeat scores showed improvement over time; HADS (anxiety) mean difference: 2.5 (95% CI: 1.2-3.7), HADS (depression) mean difference: 1.6 (95% CI: 0.3-2.9). MINI defined n = 12 (20%) with depression and n = 6 (10%) with anxiety disorder. Comparing baseline screening to 1-month clinical diagnosis, HADS sensitivity was 0.25 (95% CI: 0.09-0.53) and specificity 0.94 (95% CI: 0.84-0.98); DISCs sensitivity was 0.92 (95% CI: 0.65-0.99) and specificity 0.78 (95% CI: 0.64-0.87). Even amongst 'medically stable' stroke patients, depression/anxiety screening at the acute stage may not be feasible or accurate. Half of participants required assistance from the researcher to complete assessments. The poor predictive accuracy of HADS for depression/anxiety disorder at 1 month may be due in part to the high prevalence of cognitive impairment in our sample. Screening in the first few days after stroke does not appear useful for detecting clinically important and sustained depression/anxiety problems. © 2014 S. Karger AG, Basel.

Feasibility of streamlining an interactive Bayesian-based diagnostic support tool designed for clinical practice

NASA Astrophysics Data System (ADS)

Chen, Po-Hao; Botzolakis, Emmanuel; Mohan, Suyash; Bryan, R. N.; Cook, Tessa

2016-03-01

In radiology, diagnostic errors occur either through the failure of detection or incorrect interpretation. Errors are estimated to occur in 30-35% of all exams and contribute to 40-54% of medical malpractice litigations. In this work, we focus on reducing incorrect interpretation of known imaging features. Existing literature categorizes cognitive bias leading a radiologist to an incorrect diagnosis despite having correctly recognized the abnormal imaging features: anchoring bias, framing effect, availability bias, and premature closure. Computational methods make a unique contribution, as they do not exhibit the same cognitive biases as a human. Bayesian networks formalize the diagnostic process. They modify pre-test diagnostic probabilities using clinical and imaging features, arriving at a post-test probability for each possible diagnosis. To translate Bayesian networks to clinical practice, we implemented an entirely web-based open-source software tool. In this tool, the radiologist first selects a network of choice (e.g. basal ganglia). Then, large, clearly labeled buttons displaying salient imaging features are displayed on the screen serving both as a checklist and for input. As the radiologist inputs the value of an extracted imaging feature, the conditional probabilities of each possible diagnosis are updated. The software presents its level of diagnostic discrimination using a Pareto distribution chart, updated with each additional imaging feature. Active collaboration with the clinical radiologist is a feasible approach to software design and leads to design decisions closely coupling the complex mathematics of conditional probability in Bayesian networks with practice.

Preliminary report of a Web-based instrument to assess and teach knowledge and clinical thinking to medical student

PubMed Central

Tokunaga, Hironobu; Ando, Hirotaka; Obika, Mikako; Miyoshi, Tomoko; Tokuda, Yasuharu; Bautista, Miho; Kataoka, Hitomi; Terasawa, Hidekazu

2014-01-01

Objectives We report the preliminary development of a unique Web-based instrument for assessing and teaching knowledge and developing clinical thinking called the “Sequential Questions and Answers” (SQA) test. Included in this feasibility report are physicians’ answers to the Sequential Questions and Answers pre- and posttests and their brief questionnaire replies. Methods The authors refined the SQA test case scenario for content, ease of modifications of case scenarios, test uploading and answer retrieval. Eleven geographically distant physicians evaluated the SQA test, taking the pretest and posttest within two weeks. These physicians completed a brief questionnaire about the SQA test. Results Eleven physicians completed the SQA pre- and posttest; all answers were downloaded for analysis. They reported the ease of website login and navigating within the test module together with many helpful suggestions. Their average posttest score gain was 53% (p=0.012). Conclusions We report the successful launch of a unique Web-based instrument referred to as the Sequential Questions and Answers test. This distinctive test combines teaching organization of the clinical narrative into an assessment tool that promotes acquiring medical knowledge and clinical thinking. We successfully demonstrated the feasibility of geographically distant physicians to access the SQA instrument. The physicians’ helpful suggestions will be added to future SQA test versions. Medical schools might explore the integration of this multi-language-capable SQA assessment and teaching instrument into their undergraduate medical curriculum. PMID:25341203

Feasibility and acceptability of HIV self-testing among pre-exposure prophylaxis users in Kenya.

PubMed

Ngure, Kenneth; Heffron, Renee; Mugo, Nelly; Thomson, Kerry A; Irungu, Elizabeth; Njuguna, Njambi; Mwaniki, Lawrence; Celum, Connie; Baeten, Jared M

2017-02-10

HIV testing is key to the delivery of pre-exposure prophylaxis (PrEP): testing HIV-uninfected at-risk persons is the first step for PrEP initiation and ongoing HIV testing is an essential part of PrEP delivery. Thus, novel and cost-effective HIV-testing approaches to streamline delivery of PrEP are urgently needed. Within a demonstration project of PrEP for HIV prevention among high-risk HIV serodiscordant couples in Kenya (the Partners Demonstration Project), we conducted a pilot evaluation of HIV self-testing. Clinic visits were scheduled quarterly and included in-clinic HIV testing using fingerstick rapid HIV tests and refills of PrEP prescriptions. HIV oral fluid self-test kits were provided for participants to use in the two-month interval between scheduled quarterly clinic visits. Acceptability of HIV self-testing was assessed using both quantitative and qualitative methods. We found that 222 of 226 (98%) HIV-uninfected persons who were offered accepted self-testing. Nearly all (96.8%) reported that using the self-testing kit was easy. More than half (54.5%) reportedly did not share the HIV results from self-testing with anyone and almost all (98.7%) the participants did not share the HIV self-testing kits with anyone. Many participants reported that HIV self-testing was empowering and reduced anxiety associated with waiting between clinic HIV tests. HIV self-testing was highly acceptable and may therefore be a feasible strategy to efficiently permit routine HIV testing between PrEP refills.

Systematic drug repositioning through mining adverse event data in ClinicalTrials.gov.

PubMed

Su, Eric Wen; Sanger, Todd M

2017-01-01

Drug repositioning (i.e., drug repurposing) is the process of discovering new uses for marketed drugs. Historically, such discoveries were serendipitous. However, the rapid growth in electronic clinical data and text mining tools makes it feasible to systematically identify drugs with the potential to be repurposed. Described here is a novel method of drug repositioning by mining ClinicalTrials.gov. The text mining tools I2E (Linguamatics) and PolyAnalyst (Megaputer) were utilized. An I2E query extracts "Serious Adverse Events" (SAE) data from randomized trials in ClinicalTrials.gov. Through a statistical algorithm, a PolyAnalyst workflow ranks the drugs where the treatment arm has fewer predefined SAEs than the control arm, indicating that potentially the drug is reducing the level of SAE. Hypotheses could then be generated for the new use of these drugs based on the predefined SAE that is indicative of disease (for example, cancer).

Development of photoacoustic imaging technology overlaid on ultrasound imaging and its clinical application

NASA Astrophysics Data System (ADS)

Ishihara, Miya; Tsujita, Kazuhiro; Horiguchi, Akio; Irisawa, Kaku; Komatsu, Tomohiro; Ayaori, Makoto; Hirasawa, Takeshi; Kasamatsu, Tadashi; Hirota, Kazuhiro; Tsuda, Hitoshi; Ikewaki, Katsunori; Asano, Tomohiko

2015-03-01

Purpose: Photoacoustic imaging (PAI) enables one to visualize the distribution of hemoglobin and acquire a map of microvessels without using contrast agents. The purpose of our study is to develop a clinically applicable PAI system integrated with a clinical ultrasound (US) array system with handheld PAI probes providing coregistered PAI and US images. Clinical research trials were performed to evaluate the performance and feasibility of clinical value. Materials and Methods: We developed two types of handheld PAI probes: a linear PAI probe combining a conventional linear-array US probe with optical illumination and a transrectal ultrasonography (TRUS)-type PAI probe. We performed experiments with Japanese white rabbits and conducted clinical research trials of urology and vascular medicine with the approval of the medical human ethics committee of the National Defense Medical College. Results: We successfully acquired high-dynamic-range images of the vascular network ranging from capillaries to landmark arteries and identified the femoral vein, deep femoral vein, and great saphenous vein of rabbits. These major vessels in the rabbits groin are surrounded with microvessels connected to each other. Periprostatic microvessels were monitored during radical prostatectomy for localized prostate cancer and they were colocalized with nerve fibers, and their distribution was consistent with the corresponding PAI. The TRUS-type PAI probe clearly demonstrated the location and extent of the neurovascular bundle (NVB) better than does TRUS alone. Conclusions: The system, which can obtain a PAI, a US image, and a merged image, was innovatively designed so that medical doctors can easily find the location without any prior knowledge or extended skills to analyze the obtained images. Our pilot feasibility study confirms that PAI could be an imaging modality useful in the screening study and diagnostic biopsy.

A Microsoft Kinect-Based Point-of-Care Gait Assessment Framework for Multiple Sclerosis Patients.

PubMed

Gholami, Farnood; Trojan, Daria A; Kovecses, Jozsef; Haddad, Wassim M; Gholami, Behnood

2017-09-01

Gait impairment is a prevalent and important difficulty for patients with multiple sclerosis (MS), a common neurological disorder. An easy to use tool to objectively evaluate gait in MS patients in a clinical setting can assist clinicians to perform an objective assessment. The overall objective of this study is to develop a framework to quantify gait abnormalities in MS patients using the Microsoft Kinect for the Windows sensor; an inexpensive, easy to use, portable camera. Specifically, we aim to evaluate its feasibility for utilization in a clinical setting, assess its reliability, evaluate the validity of gait indices obtained, and evaluate a novel set of gait indices based on the concept of dynamic time warping. In this study, ten ambulatory MS patients, and ten age and sex-matched normal controls were studied at one session in a clinical setting with gait assessment using a Kinect camera. The expanded disability status scale (EDSS) clinical ambulation score was calculated for the MS subjects, and patients completed the Multiple Sclerosis walking scale (MSWS). Based on this study, we established the potential feasibility of using a Microsoft Kinect camera in a clinical setting. Seven out of the eight gait indices obtained using the proposed method were reliable with intraclass correlation coefficients ranging from 0.61 to 0.99. All eight MS gait indices were significantly different from those of the controls (p-values less than 0.05). Finally, seven out of the eight MS gait indices were correlated with the objective and subjective gait measures (Pearson's correlation coefficients greater than 0.40). This study shows that the Kinect camera is an easy to use tool to assess gait in MS patients in a clinical setting.

The NOTCH3 score: a pre-clinical CADASIL biomarker in a novel human genomic NOTCH3 transgenic mouse model with early progressive vascular NOTCH3 accumulation.

PubMed

Rutten, Julie W; Klever, Roselin R; Hegeman, Ingrid M; Poole, Dana S; Dauwerse, Hans G; Broos, Ludo A M; Breukel, Cor; Aartsma-Rus, Annemieke M; Verbeek, J Sjef; van der Weerd, Louise; van Duinen, Sjoerd G; van den Maagdenberg, Arn M J M; Lesnik Oberstein, Saskia A J

2015-12-29

CADASIL (Cerebral Autosomal Dominant Arteriopathy with Subcortical Infarcts and Leukoencephalopathy) is a hereditary small vessel disease caused by mutations in the NOTCH3 gene, leading to toxic NOTCH3 protein accumulation in the small- to medium sized arterioles. The accumulation is systemic but most pronounced in the brain vasculature where it leads to clinical symptoms of recurrent stroke and dementia. There is no therapy for CADASIL, and therapeutic development is hampered by a lack of feasible clinical outcome measures and biomarkers, both in mouse models and in CADASIL patients. To facilitate pre-clinical therapeutic interventions for CADASIL, we aimed to develop a novel, translational CADASIL mouse model. We generated transgenic mice in which we overexpressed the full length human NOTCH3 gene from a genomic construct with the archetypal c.544C > T, p.Arg182Cys mutation. The four mutant strains we generated have respective human NOTCH3 RNA expression levels of 100, 150, 200 and 350 % relative to endogenous mouse Notch3 RNA expression. Immunohistochemistry on brain sections shows characteristic vascular human NOTCH3 accumulation in all four mutant strains, with human NOTCH3 RNA expression levels correlating with age at onset and progression of NOTCH3 accumulation. This finding was the basis for developing the 'NOTCH3 score', a quantitative measure for the NOTCH3 accumulation load. This score proved to be a robust and sensitive method to assess the progression of NOTCH3 accumulation, and a feasible biomarker for pre-clinical therapeutic testing. This novel, translational CADASIL mouse model is a suitable model for pre-clinical testing of therapeutic strategies aimed at delaying or reversing NOTCH3 accumulation, using the NOTCH3 score as a biomarker.

A Randomized Phase II Dose-Response Exercise Trial among Colon Cancer Survivors: Purpose, Study Design, Methods, and Recruitment Results

PubMed Central

Brown, Justin C.; Troxel, Andrea B.; Ky, Bonnie; Damjanov, Nevena; Zemel, Babette S.; Rickels, Michael R.; Rhim, Andrew D.; Rustgi, Anil K.; Courneya, Kerry S.; Schmitz, Kathryn H.

2016-01-01

Background Observational studies indicate that higher volumes of physical activity are associated with improved disease outcomes among colon cancer survivors. The aim of this report is to describe the purpose, study design, methods, and recruitment results of the COURAGE trial, a National Cancer Institute (NCI) sponsored, phase II, randomized, dose-response exercise trial among colon cancer survivors. Methods/Results The primary objective of the COURAGE trial is to quantify the feasibility, safety, and physiologic effects of low-dose (150 min·wk−1) and high-dose (300 min·wk−1) moderate-intensity aerobic exercise compared to usual-care control group over six months. The exercise groups are provided with in-home treadmills and heart rate monitors. Between January and July 2015, 1,433 letters were mailed using a population-based state cancer registry; 126 colon cancer survivors inquired about participation, and 39 were randomized onto the study protocol. Age was associated with inquiry about study participation (P<0.001) and randomization onto the study protocol (P<0.001). No other demographic, clinical, or geographic characteristics were associated with study inquiry or randomization. The final trial participant was randomized in August 2015. Six month endpoint data collection was completed in February 2016. Discussion The recruitment of colon cancer survivors into an exercise trial is feasible. The findings from this trial will inform key design aspects for future phase 2 and phase 3 randomized controlled trials to examine the efficacy of exercise to improve clinical outcomes among colon cancer survivors. PMID:26970181

Feasibility of automatic evaluation of clinical rules in general practice.

PubMed

Opondo, Dedan; Visscher, Stefan; Eslami, Saied; Medlock, Stephanie; Verheij, Robert; Korevaar, Joke C; Abu-Hanna, Ameen

2017-04-01

To assess the extent to which clinical rules (CRs) can be implemented for automatic evaluation of quality of care in general practice. We assessed 81 clinical rules (CRs) adapted from a subset of Assessing Care of Vulnerable Elders (ACOVE) clinical rules, against Dutch College of General Practitioners (NHG) data model. Each CR was analyzed using the Logical Elements Rule METHOD: (LERM). LERM is a stepwise method of assessing and formalizing clinical rules for decision support. Clinical rules that satisfied the criteria outlined in the LERM method were judged to be implementable in automatic evaluation in general practice. Thirty-three out of 81 (40.7%) Dutch-translated ACOVE clinical rules can be automatically evaluated in electronic medical record systems. Seven out of 7 CRs (100%) in the domain of diabetes can be automatically evaluated, 9/17 (52.9%) in medication use, 5/10 (50%) in depression care, 3/6 (50%) in nutrition care, 6/13 (46.1%) in dementia care, 1/6 (16.6%) in end of life care, 2/13 (15.3%) in continuity of care, and 0/9 (0%) in the fall-related care. Lack of documentation of care activities between primary and secondary health facilities and ambiguous formulation of clinical rules were the main reasons for the inability to automate the clinical rules. Approximately two-fifths of the primary care Dutch ACOVE-based clinical rules can be automatically evaluated. Clear definition of clinical rules, improved GP database design and electronic linkage of primary and secondary healthcare facilities can improve prospects of automatic assessment of quality of care. These findings are relevant especially because the Netherlands has very high automation of primary care. Copyright © 2017 Elsevier B.V. All rights reserved.

Design of Phase II Non-inferiority Trials.

PubMed

Jung, Sin-Ho

2017-09-01

With the development of inexpensive treatment regimens and less invasive surgical procedures, we are confronted with non-inferiority study objectives. A non-inferiority phase III trial requires a roughly four times larger sample size than that of a similar standard superiority trial. Because of the large required sample size, we often face feasibility issues to open a non-inferiority trial. Furthermore, due to lack of phase II non-inferiority trial design methods, we do not have an opportunity to investigate the efficacy of the experimental therapy through a phase II trial. As a result, we often fail to open a non-inferiority phase III trial and a large number of non-inferiority clinical questions still remain unanswered. In this paper, we want to develop some designs for non-inferiority randomized phase II trials with feasible sample sizes. At first, we review a design method for non-inferiority phase III trials. Subsequently, we propose three different designs for non-inferiority phase II trials that can be used under different settings. Each method is demonstrated with examples. Each of the proposed design methods is shown to require a reasonable sample size for non-inferiority phase II trials. The three different non-inferiority phase II trial designs are used under different settings, but require similar sample sizes that are typical for phase II trials.

A multiplex primer design algorithm for target amplification of continuous genomic regions.

PubMed

Ozturk, Ahmet Rasit; Can, Tolga

2017-06-19

Targeted Next Generation Sequencing (NGS) assays are cost-efficient and reliable alternatives to Sanger sequencing. For sequencing of very large set of genes, the target enrichment approach is suitable. However, for smaller genomic regions, the target amplification method is more efficient than both the target enrichment method and Sanger sequencing. The major difficulty of the target amplification method is the preparation of amplicons, regarding required time, equipment, and labor. Multiplex PCR (MPCR) is a good solution for the mentioned problems. We propose a novel method to design MPCR primers for a continuous genomic region, following the best practices of clinically reliable PCR design processes. On an experimental setup with 48 different combinations of factors, we have shown that multiple parameters might effect finding the first feasible solution. Increasing the length of the initial primer candidate selection sequence gives better results whereas waiting for a longer time to find the first feasible solution does not have a significant impact. We generated MPCR primer designs for the HBB whole gene, MEFV coding regions, and human exons between 2000 bp to 2100 bp-long. Our benchmarking experiments show that the proposed MPCR approach is able produce reliable NGS assay primers for a given sequence in a reasonable amount of time.

Assessment of a simple, novel endoluminal method for gastrotomy closure in NOTES.

PubMed

Lee, Sang Soo; Oelschlager, Brant K; Wright, Andrew S; Soares, Renato V; Sinan, Huseyin; Montenovo, Martin I; Hwang, Joo Ha

2011-10-01

A reliable method for gastrotomy closure in NOTES will be essential for NOTES to become viable clinically. However, methods using existing and widely available endoscopic accessories have been ineffective. The objective of this study was to evaluate the feasibility and safety of a new simple method for gastric closure (retracted clip-assisted loop closure) that uses existing endoscopic accessories with minor modifications. The retracted clip-assisted loop closure technique involves deploying 3-4 Resolution(®) clips (modified by attaching a 90-cm length of suture to the end of each clip) along the margin of the gastrotomy with one jaw on the serosal surface and the other jaw on the mucosal surface. The suture strings are threaded through an endoloop. Traction is then applied to the strings causing the gastric wall to tent. The endoloop is secured below the tip of the clips, completing a full-thickness gastrotomy closure. The main outcome measures were feasibility, efficacy, and safety of the new retracted clip-assisted loop closure technique for NOTES gastrotomy closure. An air-tight seal was achieved in 100% (n = 9) of stomachs. The mean leak pressure was 116.3 (±19.4) mmHg. The retracted clip-assisted loop closure technique can be used to perform NOTES gastrotomy closure by using existing endoscopic accessories with minor modifications.

Use of shear waves for diagnosis and ablation monitoring of prostate cancer: a feasibility study

NASA Astrophysics Data System (ADS)

Gomez, A.; Rus, G.; Saffari, N.

2016-01-01

Prostate cancer remains as a major healthcare issue. Limitations in current diagnosis and treatment monitoring techniques imply that there is still a need for improvements. The efficacy of prostate cancer diagnosis is still low, generating under and over diagnoses. High intensity focused ultrasound ablation is an emerging treatment modality, which enables the noninvasive ablation of pathogenic tissue. Clinical trials are being carried out to evaluate its longterm efficacy as a focal treatment for prostate cancer. Successful treatment of prostate cancer using non-invasive modalities is critically dependent on accurate diagnostic means and is greatly benefited by a real-time monitoring system. While magnetic resonance imaging remains the gold standard for prostate imaging, its wider implementation for prostate cancer diagnosis remains prohibitively expensive. Conventional ultrasound is currently limited to guiding biopsy. Elastography techniques are emerging as a promising real-time imaging method, as cancer nodules are usually stiffer than adjacent healthy prostatic tissue. In this paper, a new transurethral approach is proposed, using shear waves for diagnosis and ablation monitoring of prostate cancer. A finite-difference time domain model is developed for studying the feasibility of the method, and an inverse problem technique based on genetic algorithms is proposed for reconstructing the location, size and stiffness parameters of the tumour. Preliminary results indicate that the use of shear waves for diagnosis and monitoring ablation of prostate cancer is feasible.

Physiotherapy for sleep disturbance in chronic low back pain: a feasibility randomised controlled trial

PubMed Central

2010-01-01

Background Sleep disturbance is becoming increasingly recognised as a clinically important symptom in people with chronic low back pain (CLBP, low back pain >12 weeks), associated with physical inactivity and depression. Current research and international clinical guidelines recommend people with CLBP assume a physically active role in their recovery to prevent chronicity, but the high prevalence of sleep disturbance in this population may be unknowingly limiting their ability to participate in exercise-based rehabilitation programmes and contributing to poor outcomes. There is currently no knowledge concerning the effectiveness of physiotherapy on sleep disturbance in people with chronic low back pain and no evidence of the feasibility of conducting randomized controlled trials that comprehensively evaluate sleep as an outcome measure in this population. Methods/Design This study will evaluate the feasibility of a randomised controlled trial (RCT), exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. A presenting sample of 60 consenting patients will be recruited in the physiotherapy department of Beaumont Hospital, Dublin, Ireland, and randomly allocated to one of the three groups in a concealed manner. The main outcomes will be sleep quality (self-report and objective measurement), and self-reported functional disability, pain, quality of life, fear avoidance, anxiety and depression, physical activity, and patient satisfaction. Outcome will be evaluated at baseline, 3 months and 6 months. Qualitative telephone interviews will be embedded in the research design to obtain feedback from a sample of participants' about their experiences of sleep monitoring, trial participation and interventions, and to inform the design of a fully powered future RCT. Planned analysis will explore trends in the data, effect sizes and clinically important effects (quantitative data), and thematic analysis (qualitative data). Discussion This study will evaluate the feasibility of a randomised controlled trial exploring the effects of three forms of physiotherapy (supervised general exercise programme, individualized walking programme and usual physiotherapy, which will serve as the control group) on sleep quality in people with chronic low back pain. Trial Registration Current controlled trial ISRCTN54009836 PMID:20398349

WE-EF-BRA-12: Magnetic Resonance- Guided High-Intensity Focused Ultrasound for Localized Ablation of Head and Neck Tissue Structures: A Feasibility Study in An Animal Model

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

Partanen, A; Ellens, N; Noureldine, S

Purpose: High-intensity focused ultrasound (HIFU) ablation is feasible in the head and neck [1]. This study aims to expand upon these findings to assess the feasibility of treatment planning and monitoring via magnetic resonance imaging (MRI) guidance using a clinical MR-guided HIFU platform. Methods: Two 31 kg pigs were anaesthetized, shaved, and positioned prone on the HIFU table (Sonalleve, Philips Healthcare, Vantaa, Finland). The necks were acoustically coupled to the integrated transducer using gel pads and degassed water. MR imaging verified acoustic coupling and facilitated target selection in the thyroid and thymus. Targets were thermally ablated with 130–200 W ofmore » acoustic power over a period of 16 s at a frequency of 1.2 MHz while being monitored through real-time, multi-planar MR-thermometry. Contrast-enhanced MR imaging was used to assess treatment efficacy. Post-treatment, animals were euthanized and sonicated tissues were harvested for histology assessment. Results: MR-thermometry, post-contrast-imaging, and gross pathology demonstrated that the system was capable of causing localized thermal ablation in both the thyroid and the thymus without damaging the aerodigestive tract. In one animal, superficial bruising was observed in the ultrasound beam path. Otherwise, there were no adverse events. Analysis of the tissue histology found regions of damage consistent with acute thermal injury at the targeted locations. Conclusion: It is feasible to use a clinical MR-guided HIFU platform for extracorporeal ablation of porcine head and neck tissues. MR guidance and thermometry are sufficient to target and monitor treatment in the thyroid region, despite the presence of the inhomogeneous aerodigestive tract. Further study is necessary to assess efficacy and survival using a tumor model, and to examine what modifications should be made to the transducer positioning system and associated patient positioning aids to adapt it for clinical head and neck targets.Reference:[1] Esnault et al. (2011). Thyroid, 21(9), 965– 973. Funding support provided by Philips Healthcare. Ari Partanen is a paid employee of Philips Healthcare.« less

Feasibility study of a clinical decision support system for the management of multimorbid seniors in primary care: study protocol.

PubMed

Weltermann, Birgitta; Kersting, Christine

2016-01-01

Care for seniors is complex because patients often have more than one disease, one medication, and one physician. It is a key challenge for primary care physicians to structure the various aspects of each patient's care, to integrate each patient's preferences, and to maintain a long-term overview. This article describes the design for the development and feasibility testing of the clinical decision support system (CDSS) eCare*Seniors© which is electronic health record (EHR)-based allowing for a long-term, comprehensive, evidence-based, and patient preference-oriented management of multimorbid seniors. This mixed-methods study is designed in three steps. First, focus groups and practice observations will be conducted to develop criteria for software design from a physicians' and practice assistants' perspective. Second, based on these criteria, a CDSS prototype will be developed. Third, the prototype's feasibility will be tested by five primary care practices in the care of 30 multimorbid seniors. Primary outcome is the usability of the software measured by the validated system usability scale (SUS) after 3 months. Secondary outcomes are the (a) willingness to routinely use the CDSS, (b) degree of utilization of the CDSS, (c) acceptance of the CDSS, (d) willingness of the physicians to purchase the CDSS, and (e) willingness of the practice assistants to use the CDSS in the long term. These outcomes will be measured using semi-structured interviews and software usage data. If the SUS score reaches ≥70 %, feasibility testing will be judged successful. Otherwise, the CDSS prototype will be refined according to the users' needs and retested by the physicians and practice assistants until it is fully adapted to their requirements and reaches a usability score ≥70 %. The study will support the development of a CDSS which is primary care-defined, user-friendly, easy-to-comprehend, workflow-oriented, and comprehensive. The software will assist physicians and practices in their long-term, individualized care for multimorbid seniors. German Clinical Trials Register, DRKS00008777.

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

PubMed Central

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

2013-01-01

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

Improving the Computational Effort of Set-Inversion-Based Prandial Insulin Delivery for Its Integration in Insulin Pumps

PubMed Central

León-Vargas, Fabian; Calm, Remei; Bondia, Jorge; Vehí, Josep

2012-01-01

Objective Set-inversion-based prandial insulin delivery is a new model-based bolus advisor for postprandial glucose control in type 1 diabetes mellitus (T1DM). It automatically coordinates the values of basal–bolus insulin to be infused during the postprandial period so as to achieve some predefined control objectives. However, the method requires an excessive computation time to compute the solution set of feasible insulin profiles, which impedes its integration into an insulin pump. In this work, a new algorithm is presented, which reduces computation time significantly and enables the integration of this new bolus advisor into current processing features of smart insulin pumps. Methods A new strategy was implemented that focused on finding the combined basal–bolus solution of interest rather than an extensive search of the feasible set of solutions. Analysis of interval simulations, inclusion of physiological assumptions, and search domain contractions were used. Data from six real patients with T1DM were used to compare the performance between the optimized and the conventional computations. Results In all cases, the optimized version yielded the basal–bolus combination recommended by the conventional method and in only 0.032% of the computation time. Simulations show that the mean number of iterations for the optimized computation requires approximately 3.59 s at 20 MHz processing power, in line with current features of smart pumps. Conclusions A computationally efficient method for basal–bolus coordination in postprandial glucose control has been presented and tested. The results indicate that an embedded algorithm within smart insulin pumps is now feasible. Nonetheless, we acknowledge that a clinical trial will be needed in order to justify this claim. PMID:23294789

Enhancing the population impact of collaborative care interventions: Mixed method development and implementation of stepped care targeting posttraumatic stress disorder and related comorbidities after acute trauma

PubMed Central

Zatzick, Douglas; Rivara, Frederick; Jurkovich, Gregory; Russo, Joan; Trusz, Sarah Geiss; Wang, Jin; Wagner, Amy; Stephens, Kari; Dunn, Chris; Uehara, Edwina; Petrie, Megan; Engel, Charles; Davydow, Dimitri; Katon, Wayne

2011-01-01

Objective To develop and implement a stepped collaborative care intervention targeting PTSD and related co-morbidities to enhance the population impact of early trauma-focused interventions. Method We describe the design and implementation of the Trauma Survivors Outcomes & Support Study (TSOS II). An interdisciplinary treatment development team was comprised of trauma surgical, clinical psychiatric and mental health services “change agents” who spanned the boundaries between front-line trauma center clinical care and acute care policy. Mixed method clinical epidemiologic and clinical ethnographic studies informed the development of PTSD screening and intervention procedures. Results Two-hundred and seven acutely injured trauma survivors with high early PTSD symptom levels were randomized into the study. The stepped collaborative care model integrated care management (i.e., posttraumatic concern elicitation and amelioration, motivational interviewing, and behavioral activation) with cognitive behavioral therapy and pharmacotherapy targeting PTSD. The model was feasibly implemented by front-line acute care MSW and ARNP providers. Conclusions Stepped care protocols targeting PTSD may enhance the population impact of early interventions developed for survivors of individual and mass trauma by extending the reach of collaborative care interventions to acute care medical settings and other non-specialty posttraumatic contexts. PMID:21596205

Evaluation of image features and classification methods for Barrett's cancer detection using VLE imaging

NASA Astrophysics Data System (ADS)

Klomp, Sander; van der Sommen, Fons; Swager, Anne-Fré; Zinger, Svitlana; Schoon, Erik J.; Curvers, Wouter L.; Bergman, Jacques J.; de With, Peter H. N.

2017-03-01

Volumetric Laser Endomicroscopy (VLE) is a promising technique for the detection of early neoplasia in Barrett's Esophagus (BE). VLE generates hundreds of high resolution, grayscale, cross-sectional images of the esophagus. However, at present, classifying these images is a time consuming and cumbersome effort performed by an expert using a clinical prediction model. This paper explores the feasibility of using computer vision techniques to accurately predict the presence of dysplastic tissue in VLE BE images. Our contribution is threefold. First, a benchmarking is performed for widely applied machine learning techniques and feature extraction methods. Second, three new features based on the clinical detection model are proposed, having superior classification accuracy and speed, compared to earlier work. Third, we evaluate automated parameter tuning by applying simple grid search and feature selection methods. The results are evaluated on a clinically validated dataset of 30 dysplastic and 30 non-dysplastic VLE images. Optimal classification accuracy is obtained by applying a support vector machine and using our modified Haralick features and optimal image cropping, obtaining an area under the receiver operating characteristic of 0.95 compared to the clinical prediction model at 0.81. Optimal execution time is achieved using a proposed mean and median feature, which is extracted at least factor 2.5 faster than alternative features with comparable performance.

Clinical study of heparin-free hemodialysis with the inside of hollow fibers in dialyzer coated by human albumins.

PubMed

Wu, Xixin; Chen, Huaji

2002-12-01

To investigate the therapeutics of heparin-free hemodialysis (HD) with the inside of hollow fibers in a dialyzer coated with human albumins (HFHd-A1). Clinical contrast study between HFHd-A1 and heparin-free HD with hollow fibers in dialyzer by normal saline flush (HFHd-NS) was performed by adopting the cross-over design method. The dialysis effect, the effect on life signs, blood platelet functions, change of dialyzer fiber-bundle volume, appearance image, and image of scanning electron microscopy of the inside of hollow fibers in dialyzer after dialysis and the biocompatibility of dialyzer of two HD methods were compared. HFHd-A1 could overcome all shortcomings of HFHd-NS and had more merits and increased expenses for HFHd-A1 were not high. HFHd-A1 was an effective and feasible method which could salvage patients with bleeding diseases or bleeding tendency and who need HD. Copyright 2002 S. Karger AG, Basel

Estimating clinical chemistry reference values based on an existing data set of unselected animals.

PubMed

Dimauro, Corrado; Bonelli, Piero; Nicolussi, Paola; Rassu, Salvatore P G; Cappio-Borlino, Aldo; Pulina, Giuseppe

2008-11-01

In an attempt to standardise the determination of biological reference values, the International Federation of Clinical Chemistry (IFCC) has published a series of recommendations on developing reference intervals. The IFCC recommends the use of an a priori sampling of at least 120 healthy individuals. However, such a high number of samples and laboratory analysis is expensive, time-consuming and not always feasible, especially in veterinary medicine. In this paper, an alternative (a posteriori) method is described and is used to determine reference intervals for biochemical parameters of farm animals using an existing laboratory data set. The method used was based on the detection and removal of outliers to obtain a large sample of animals likely to be healthy from the existing data set. This allowed the estimation of reliable reference intervals for biochemical parameters in Sarda dairy sheep. This method may also be useful for the determination of reference intervals for different species, ages and gender.

Owner-collected swabs of pets: a method fit for the purpose of zoonoses research.

PubMed

Möbius, N; Hille, K; Verspohl, J; Wefstaedt, P; Kreienbrock, L

2013-09-01

As part of the preparation of a large cohort study in the entire German population, this study examined the feasibility of cat and dog owners collecting nasal and oral swabs of their animals at home as a method of assessing exposure to zoonoses. In veterinary clinics in Hannover, Germany, 100 pet owners were recruited. Nasal and oral swabs of pets were taken by a veterinarian at the clinic and owners took swabs at home. Swabs were analysed regarding bacterial growth and compared (owner vs. vet) using Cohen's kappa and McNemar's test. The return rate of kits was 92%, and 77% of owners thought it unnecessary to have veterinarian assistance to swab the mouth. McNemar's test results: oral swabs 78% agreement with Gram-positive bacterial growth, 87% agreement with Gram-negative bacterial growth; with similar results for nasal swabs. Although sample quality differed, this method allowed the receipt of swabs from pets in order to obtain information about colonization with zoonotic pathogens.

Adaptive power priors with empirical Bayes for clinical trials.

PubMed

Gravestock, Isaac; Held, Leonhard

2017-09-01

Incorporating historical information into the design and analysis of a new clinical trial has been the subject of much discussion as a way to increase the feasibility of trials in situations where patients are difficult to recruit. The best method to include this data is not yet clear, especially in the case when few historical studies are available. This paper looks at the power prior technique afresh in a binomial setting and examines some previously unexamined properties, such as Box P values, bias, and coverage. Additionally, it proposes an empirical Bayes-type approach to estimating the prior weight parameter by marginal likelihood. This estimate has advantages over previously criticised methods in that it varies commensurably with differences in the historical and current data and can choose weights near 1 when the data are similar enough. Fully Bayesian approaches are also considered. An analysis of the operating characteristics shows that the adaptive methods work well and that the various approaches have different strengths and weaknesses. Copyright © 2017 John Wiley & Sons, Ltd.

New decision criteria for selecting delta check methods based on the ratio of the delta difference to the width of the reference range can be generally applicable for each clinical chemistry test item.

PubMed

Park, Sang Hyuk; Kim, So-Young; Lee, Woochang; Chun, Sail; Min, Won-Ki

2012-09-01

Many laboratories use 4 delta check methods: delta difference, delta percent change, rate difference, and rate percent change. However, guidelines regarding decision criteria for selecting delta check methods have not yet been provided. We present new decision criteria for selecting delta check methods for each clinical chemistry test item. We collected 811,920 and 669,750 paired (present and previous) test results for 27 clinical chemistry test items from inpatients and outpatients, respectively. We devised new decision criteria for the selection of delta check methods based on the ratio of the delta difference to the width of the reference range (DD/RR). Delta check methods based on these criteria were compared with those based on the CV% of the absolute delta difference (ADD) as well as those reported in 2 previous studies. The delta check methods suggested by new decision criteria based on the DD/RR ratio corresponded well with those based on the CV% of the ADD except for only 2 items each in inpatients and outpatients. Delta check methods based on the DD/RR ratio also corresponded with those suggested in the 2 previous studies, except for 1 and 7 items in inpatients and outpatients, respectively. The DD/RR method appears to yield more feasible and intuitive selection criteria and can easily explain changes in the results by reflecting both the biological variation of the test item and the clinical characteristics of patients in each laboratory. We suggest this as a measure to determine delta check methods.

A Study to Determine the Best Model and the Optimal Feasible Method for Reducing No-Show Behavior at a Military Social Work Clinic.

DTIC Science & Technology

1983-05-01

AVAILABILITY OF REPORT Approved for public release; 2b. DECLASSIFICATION I DOWNGRADING SCHEDULE Distribution Unlimited 4. PERFORMING ORGANIZATION REPORT NUMBER(S...S. MONITORING ORGANIZATION REPORT NUMBER(S) 1-88 6a. NAME OF PERFORMING ORGANIZATION 6b. OFFICE SYMBOL 7a. NAME OF MONITORING ORGANIZATION U.S. Army...identify by block number) FIELD GROUP SUB-GROUP Health Care; Appointment Absenteeism - ... 19, ABSTRACT (Continue on reverse if necessary and identify

The failure of AHERF: 5 important lessons.

PubMed

Goldstein, Lisa

2008-08-01

Important lessons from AHERF's downfall: Strong governance and oversight of management are needed to ensure accountability; Disciplined growth strategies need to be supported by rigorous financial planning and feasibility analysis; Physician integration is critical to grow market share, but needs to be methodical and measured; Robust information systems are necessary to manage costs, maximize revenue, and provide differentiation in quality and clinical outcomes; Disclosure of the financial performance of all of a health system's operations creates greater transparency and builds credibility.

Optimizing care for the obese patient in interventional radiology

PubMed Central

Aberle, Dwight; Charles, Hearns; Hodak, Steven; O’Neill, Daniel; Oklu, Rahmi; Deipolyi, Amy R.

2017-01-01

With the rising epidemic of obesity, interventional radiologists are treating increasing numbers of obese patients, as comorbidities associated with obesity preclude more invasive treatments. These patients are at heightened risk of vascular and oncologic disease, both of which often require interventional radiology care. Obese patients pose unique challenges in imaging, technical feasibility, and periprocedural monitoring. This review describes the technical and clinical challenges posed by this population, with proposed methods to mitigate these challenges and optimize care. PMID:28082253

Validity and Feasibility of a Digital Diet Estimation Method for Use with Preschool Children: A Pilot Study

ERIC Educational Resources Information Center

Nicklas, Theresa A.; O'Neil, Carol E.; Stuff, Janice; Goodell, Lora Suzanne; Liu, Yan; Martin, Corby K.

2012-01-01

Objective: The goal of the study was to assess the validity and feasibility of a digital diet estimation method for use with preschool children in "Head Start." Methods: Preschool children and their caregivers participated in validation (n = 22) and feasibility (n = 24) pilot studies. Validity was determined in the metabolic research unit using…

Feasibility of a multicentre, randomised controlled trial of laparoscopic versus open colorectal surgery in the acute setting: the LaCeS feasibility trial protocol.

PubMed

Harji, Deena; Marshall, Helen; Gordon, Katie; Crow, Hannah; Hiley, Victoria; Burke, Dermot; Griffiths, Ben; Moriarty, Catherine; Twiddy, Maureen; O'Dwyer, John L; Verjee, Azmina; Brown, Julia; Sagar, Peter

2018-02-22

Acute colorectal surgery forms a significant proportion of emergency admissions within the National Health Service. There is limited evidence to suggest minimally invasive surgery may be associated with improved clinical outcomes in this cohort of patients. Consequently, there is a need to assess the clinical effectiveness and cost-effectiveness of laparoscopic surgery in the acute colorectal setting. However,emergency colorectal surgical trials have previously been difficult to conduct due to issues surrounding recruitment and equipoise. The LaCeS (randomised controlled trial of Laparoscopic versus open Colorectal Surgery in the acute setting) feasibility trial will determine the feasibility of conducting a definitive, phase III trial of laparoscopic versus open acute colorectal resection. The LaCeS feasibility trial is a prospective, multicentre, single-blinded, parallel group, pragmatic randomised controlled feasibility trial. Patients will be randomised on a 1:1 basis to receive eitherlaparoscopic or open surgery. The trial aims to recruit at least 66 patients from five acute general surgical units across the UK. Patients over the age of 18 with a diagnosis of acute colorectal pathology requiring resection on clinical and radiological/endoscopic investigations, with a National Confidential Enquiry into Patient Outcome and Death classification of urgent will be considered eligible for participation. The primary outcome is recruitment. Secondary outcomes include assessing the safety profile of laparoscopic surgery using intraoperative and postoperative complication rates, conversion rates and patient-safety indicators as surrogate markers. Clinical and patient-reported outcomes will also be reported. The trial will contain an embedded qualitative study to assess clinician and patient acceptability of trial processes. The LaCeS feasibility trial is approved by the Yorkshire and The Humber, Bradford Leeds Research Ethics Committee (REC reference: 15/ YH/0542). The results from the trial will be presented at national and international colorectal conferences and will be submitted for publication to peer-reviewed journals. ISRCTN15681041; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Automation and Intensity Modulated Radiation Therapy for Individualized High-Quality Tangent Breast Treatment Plans

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

Purdie, Thomas G., E-mail: Tom.Purdie@rmp.uhn.on.ca; Department of Radiation Oncology, University of Toronto, Toronto, Ontario; Techna Institute, University Health Network, Toronto, Ontario

Purpose: To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Methods and Materials: Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to definemore » and simplify the technical aspects of the treatment planning process. Results: Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Conclusions: Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use.« less

An Overview of Internal and External Fixation Methods for the Diabetic Charcot Foot and Ankle.

PubMed

Ramanujam, Crystal L; Zgonis, Thomas

2017-01-01

Diabetic Charcot neuroarthropathy (DCN) of the foot and ankle is a challenging disease with regard to clinical presentation, pathogenesis, and prognosis. Its surgical management is equally difficult to interpret based on the wide array of options available. In the presence of an ulceration or concomitant osteomyelitis, internal fixation by means of screws, plates, or intramedullary nailing needs to be avoided when feasible. External fixation becomes a great surgical tool when managing DCN with concomitant osteomyelitis. This article describes internal and external fixation methods along with available literature to enlighten surgeons faced with treating this complex condition. Copyright © 2016 Elsevier Inc. All rights reserved.

Tibetan medicine "RNSP" in treatment of Alzheimer disease.

PubMed

Shi, Jing-Ming; He, Xue; Lian, Hui-Juan; Yuan, Dong-Ya; Hu, Qun-Ying; Sun, Zheng-Qi; Li, Yan-Song; Zeng, Yu-Wen

2015-01-01

Alzheimer disease (Alzheimer Disease, AD) is one of the most common type in senile dementia. Its main pathological features were that a large number of senile plaques gathered in brain extracellular and tangles fibrosis appeared in nerve cells. Currently, the pathogenesis of AD is still uncertain, and scale investigation and combined brain CT, MRI data were analyzed mainly for clinical diagnosis. Mitigation and improvement of the nervous system activity to interfere with the subsequent behavior of the patients are the main methods for treatment. In clinical no drug can really prevent and cure AD. From the view point of Tibetan medicine studies, Tibetan medicine RNSP has effect on improving memory and repairing the neurons in the brain. In this study, we combined the characteristics of AD pathology, pathogenesis, diagnosis and treatment methods to explore the feasibility of Tibetan medicine RNSP for the treatment of AD to provide new ideas for the diagnosis and treatment of AD.

Systematic review: cultural adaptation and feasibility of screening for autism in non-English speaking countries.

PubMed

Al Maskari, Turkiya S; Melville, Craig A; Willis, Diane S

2018-01-01

Screening children for autism has gained wider acceptance within clinical practice, and early intervention has improved outcomes. Increasingly, adapting an existing screening instrument is a common, fast method to create a usable screening tool, especially for countries with limited resources and/or expertise. However, concerns have been raised regarding adaptation adequacy and the feasibility of screening across cultural groups. This study systematically examined the levels of cultural adaptation and feasibility aspects considered when screening for autism in non-English speaking countries to build upon the sparse knowledge that exists on this topic in the literature. Nineteen studies, obtained from five electronic databases, were examined. PRISMA guidance was used for this review. The Ecological Validity Framework model, and Bowen Recommendations for Feasibility were adopted to extract relevant data, which was synthesised narratively. Cultural adaptation within the included studies mostly involved language translation with little information offered to enable conclusions on how the processes were guided and maintained. Few cultural adjustments involved modifying screening methods; clarifying difficult concepts and changing instrument content were employed to address the core values, competence, beliefs, and norms of the adapted culture. However, less attention was given to adapt the screening goals within the context of cultural values, and customs or to consider interactional match between the clients and assessors. The review also highlighted an acceptable level of practicality to screen for autism but did not encourage integrating autism screening within routine practice or beyond the study context for different cultures. Concurring with previous literature, we agree that knowledge on cultural adaptation for autism screening instruments is limited and not sufficiently documented to establish adaptation levels (process and/or contents), and prove adequacy. However, this review provides an infrastructure to improve future adaptation processes. Integrating autism screening as routine medical practice is not encouraged and warrants further feasibility studies to minimize wasted resources and improve screening effectiveness in various health care systems.

A Novel Form of Breast Intraoperative Radiation Therapy With CT-Guided High-Dose-Rate Brachytherapy: Results of a Prospective Phase 1 Clinical Trial

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

Showalter, Shayna L., E-mail: snl2t@virginia.edu; Petroni, Gina; Trifiletti, Daniel M.

Purpose: Existing intraoperative radiation therapy (IORT) techniques are criticized for the lack of image guided treatment planning and energy deposition with, at times, poor resultant dosimetry and low radiation dose. We pioneered a novel method of IORT that incorporates customized, computed tomography (CT)-based treatment planning and high-dose-rate (HDR) brachytherapy to overcome these drawbacks: CT-HDR-IORT. Methods and Materials: A phase 1 study was conducted to demonstrate the feasibility and safety of CT-HDR-IORT. Eligibility criteria included age ≥50 years, invasive or in situ breast cancer, tumor size <3 cm, and N0 disease. Patients were eligible before or within 30 days of breast-conserving surgery (BCS). BCSmore » was performed, and a multilumen balloon catheter was placed. CT images were obtained, a customized HDR brachytherapy plan was created, and a dose of 12.5 Gy was delivered to 1-cm depth from the balloon surface. The catheter was removed, and the skin was closed. The primary endpoints were feasibility and acute toxicity. Feasibility was defined as IORT treatment interval (time from CT acquisition until IORT completion) ≤90 minutes. The secondary endpoints included dosimetry, cosmetic outcome, quality of life, and late toxicity. Results: Twenty-eight patients were enrolled. The 6-month follow-up assessments were completed by 93% of enrollees. The median IORT treatment interval was 67.2 minutes (range, 50-108 minutes). The treatment met feasibility criteria in 26 women (93%). The dosimetric goals were met in 22 patients (79%). There were no Radiation Therapy Oncology Group grade 3+ toxicities; 6 patients (21%) experienced grade 2 events. Most patients (93%) had good/excellent cosmetic outcomes at the last follow-up visit. Conclusions: CT-HDR-IORT is feasible and safe. This promising approach for a conformal, image-based, higher-dose breast IORT is being evaluated in a phase 2 trial.« less

Acceptability and feasibility of mHealth and community-based directly observed antiretroviral therapy to prevent mother-to-child HIV transmission in South African pregnant women under Option B+: an exploratory study

PubMed Central

Nachega, Jean B; Skinner, Donald; Jennings, Larissa; Magidson, Jessica F; Altice, Frederick L; Burke, Jessica G; Lester, Richard T; Uthman, Olalekan A; Knowlton, Amy R; Cotton, Mark F; Anderson, Jean R; Theron, Gerhard B

2016-01-01

Objective To examine the acceptability and feasibility of mobile health (mHealth)/short message service (SMS) and community-based directly observed antiretroviral therapy (cDOT) as interventions to improve antiretroviral therapy (ART) adherence for preventing mother-to-child human immunodeficiency virus (HIV) transmission (PMTCT). Design and methods A mixed-method approach was used. Two qualitative focus group discussions with HIV-infected pregnant women (n=20) examined the acceptability and feasibility of two ART adherence interventions for PMTCT: 1) SMS text messaging and 2) patient-nominated cDOT supporters. Additionally, 109 HIV-infected, pregnant South African women (18–30 years old) receiving PMTCT services under single-tablet antiretroviral therapy regimen during pregnancy and breastfeeding and continuing for life (“Option B+”) were interviewed about mobile phone access, SMS use, and potential treatment supporters. Setting A community primary care clinic in Cape Town, South Africa. Participants HIV-infected pregnant women. Main outcomes Acceptability and feasibility of mHealth and cDOT interventions. Results Among the 109 women interviewed, individual mobile phone access and SMS use were high (>90%), and 88.1% of women were interested in receiving SMS ART adherence support messages such as reminders, motivation, and medication updates. Nearly all women (95%) identified at least one person close to them to whom they had disclosed their HIV status and would nominate as a cDOT supporter. Focus group discussions revealed that cDOT supporters and adherence text messages were valued, but some concerns regarding supporter time availability and risk of unintended HIV status disclosure were expressed. Conclusion mHealth and/or cDOT supporter as interventions to improve ART adherence are feasible in this setting. However, safe HIV status disclosure to treatment supporters and confidentiality of text messaging content about HIV and ART were deemed crucial. PMID:27175068

Clinical high-resolution mapping of the proteoglycan-bound water fraction in articular cartilage of the human knee joint.

PubMed

Bouhrara, Mustapha; Reiter, David A; Sexton, Kyle W; Bergeron, Christopher M; Zukley, Linda M; Spencer, Richard G

2017-11-01

We applied our recently introduced Bayesian analytic method to achieve clinically-feasible in-vivo mapping of the proteoglycan water fraction (PgWF) of human knee cartilage with improved spatial resolution and stability as compared to existing methods. Multicomponent driven equilibrium single-pulse observation of T 1 and T 2 (mcDESPOT) datasets were acquired from the knees of two healthy young subjects and one older subject with previous knee injury. Each dataset was processed using Bayesian Monte Carlo (BMC) analysis incorporating a two-component tissue model. We assessed the performance and reproducibility of BMC and of the conventional analysis of stochastic region contraction (SRC) in the estimation of PgWF. Stability of the BMC analysis of PgWF was tested by comparing independent high-resolution (HR) datasets from each of the two young subjects. Unlike SRC, the BMC-derived maps from the two HR datasets were essentially identical. Furthermore, SRC maps showed substantial random variation in estimated PgWF, and mean values that differed from those obtained using BMC. In addition, PgWF maps derived from conventional low-resolution (LR) datasets exhibited partial volume and magnetic susceptibility effects. These artifacts were absent in HR PgWF images. Finally, our analysis showed regional variation in PgWF estimates, and substantially higher values in the younger subjects as compared to the older subject. BMC-mcDESPOT permits HR in-vivo mapping of PgWF in human knee cartilage in a clinically-feasible acquisition time. HR mapping reduces the impact of partial volume and magnetic susceptibility artifacts compared to LR mapping. Finally, BMC-mcDESPOT demonstrated excellent reproducibility in the determination of PgWF. Published by Elsevier Inc.

Design and methods for a pilot randomized clinical trial involving exercise and behavioral activation to treat comorbid type 2 diabetes and major depressive disorder

PubMed Central

Schneider, Kristin L.; Pagoto, Sherry L.; Handschin, Barbara; Panza, Emily; Bakke, Susan; Liu, Qin; Blendea, Mihaela; Ockene, Ira S.; Ma, Yunsheng

2011-01-01

Background The comorbidity of type 2 diabetes mellitus (T2DM) and depression is associated with poor glycemic control. Exercise has been shown to improve mood and glycemic control, but individuals with comorbid T2DM and depression are disproportionately sedentary compared to the general population and report more difficulty with exercise. Behavioral activation, an evidence-based depression psychotherapy, was designed to help people with depression make gradual behavior changes, and may be helpful to build exercise adherence in sedentary populations. This pilot randomized clinical trial will test the feasibility of a group exercise program enhanced with behavioral activation strategies among women with comorbid T2DM and depression. Methods/Design Sedentary women with inadequately controlled T2DM and depression (N=60) will be randomly assigned to one of two conditions: exercise or usual care. Participants randomized to the exercise condition will attend 38 behavioral activation-enhanced group exercise classes over 24 weeks in addition to usual care. Participants randomized to the usual care condition will receive depression treatment referrals and print information on diabetes management via diet and physical activity. Assessments will occur at baseline and 3-, 6-, and 9-months following randomization. The goals of this pilot study are to demonstrate feasibility and intervention acceptability, estimate the resources and costs required to deliver the intervention and to estimate the standard deviation of continuous outcomes (e.g., depressive symptoms and glycosylated hemoglobin) in preparation for a fully-powered randomized clinical trial. Discussion A novel intervention that combines exercise and behavioral activation strategies could potentially improve glycemic control and mood in women with comorbid type 2 diabetes and depression. Trial registration NCT01024790 PMID:21765864

Outcomes of Interventions Via a Transradial Approach for Dysfunctional Brescia-Cimino Fistulas

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

Chen Shyhming; Hang Chiling; Yip Honkan

2009-09-15

The transradial artery approach to angioplasty has rarely been reported as a method for treating dysfunctional Brescia-Cimino fistulas. This study evaluated the feasibility, safety, and 1-year efficacy of this method for treating dysfunctional Brescia-Cimino fistulas. We retrospectively evaluated 154 consecutive procedures in 131 patients (age, 58.3 {+-} 11.6 years; male, 48.1%) who underwent the transradial approach in dysfunctional Brescia-Cimino fistulas in the 1-year period after the procedure. The operator determined the use of a regular or a cutting balloon (two cases) in combination with urokinase injection (one case) or catheter thromboaspiration. Radial artery puncture was successful in all cases. Fifty-twomore » cases (33.8%) had totally occluded fibrotic lesions. The overall anatomic success rate and clinical success rate were 61% (94/154) and 81.1% (125/154), respectively. In cases with a totally occluded fibrotic lesion, the clinical success rate was 46%. Successful intervention was associated with a significant reduction in the radial arterial systolic and diastolic pressures. There were no complications of symptomatic arterial embolization or pulmonary embolism, and one complication of venous rupture was successfully treated by compression. The primary patency rates based on intention-to-treat were 75.3% at 30 days and 39.0% at 1 year after the procedure. Excluding the cases with a totally occluded lesion, the clinical success rate was 99% (101/102) and the primary patency rates were 84.3% (86/102) and 52.0% (53/102) at 3 months and 1 year after the procedure, respectively. In conclusion, the transradial approach is a feasible, safe, and effective alternative for catheter intervention for dysfunctional Brescia-Cimino fistulas. Its success rate in cases with a totally occluded fibrotic lesion is unsatisfactory.« less

Dual-energy contrast-enhanced digital mammography (DE-CEDM): optimization on digital subtraction with practical x-ray low/high-energy spectra

NASA Astrophysics Data System (ADS)

Chen, Biao; Jing, Zhenxue; Smith, Andrew P.; Parikh, Samir; Parisky, Yuri

2006-03-01

Dual-energy contrast enhanced digital mammography (DE-CEDM), which is based upon the digital subtraction of low/high-energy image pairs acquired before/after the administration of contrast agents, may provide physicians physiologic and morphologic information of breast lesions and help characterize their probability of malignancy. This paper proposes to use only one pair of post-contrast low / high-energy images to obtain digitally subtracted dual-energy contrast-enhanced images with an optimal weighting factor deduced from simulated characteristics of the imaging chain. Based upon our previous CEDM framework, quantitative characteristics of the materials and imaging components in the x-ray imaging chain, including x-ray tube (tungsten) spectrum, filters, breast tissues / lesions, contrast agents (non-ionized iodine solution), and selenium detector, were systemically modeled. Using the base-material (polyethylene-PMMA) decomposition method based on entrance low / high-energy x-ray spectra and breast thickness, the optimal weighting factor was calculated to cancel the contrast between fatty and glandular tissues while enhancing the contrast of iodized lesions. By contrast, previous work determined the optimal weighting factor through either a calibration step or through acquisition of a pre-contrast low/high-energy image pair. Computer simulations were conducted to determine weighting factors, lesions' contrast signal values, and dose levels as functions of x-ray techniques and breast thicknesses. Phantom and clinical feasibility studies were performed on a modified Selenia full field digital mammography system to verify the proposed method and computer-simulated results. The resultant conclusions from the computer simulations and phantom/clinical feasibility studies will be used in the upcoming clinical study.

High-Resolution Echo-Planar Spectroscopic Imaging of the Human Calf

PubMed Central

Weis, Jan; Bruvold, Morten; Ortiz-Nieto, Francisco; Ahlström, Håkan

2014-01-01

Background This study exploits the speed benefits of echo-planar spectroscopic imaging (EPSI) to acquire lipid spectra of skeletal muscle. The main purpose was to develop a high-resolution EPSI technique for clinical MR scanner, to visualise the bulk magnetic susceptibility (BMS) shifts of extra-myocellular lipid (EMCL) spectral lines, and to investigate the feasibility of this method for the assessment of intra-myocellular (IMCL) lipids. Methods The study group consisted of six healthy volunteers. A two dimensional EPSI sequence with point-resolved spectroscopy (PRESS) spatial localization was implemented on a 3T clinical MR scanner. Measurements were performed by means of 64×64 spatial matrix and nominal voxel size 3×3×15 mm3. The total net measurement time was 3 min 12 sec for non-water-suppressed (1 acquisition) and 12 min 48 sec for water-suppressed scans (4 acquisitions). Results Spectra of the human calf had a very good signal-to-noise ratio and linewidths sufficient to differentiate IMCL resonances from EMCL. The use of a large spatial matrix reduces inter-voxel signal contamination of the strong EMCL signals. Small voxels enabled visualisation of the methylene EMCL spectral line splitting and their BMS shifts up to 0.5 ppm relative to the correspondent IMCL line. The mean soleus muscle IMCL content of our six volunteers was 0.30±0.10 vol% (range 0.18–0.46) or 3.6±1.2 mmol/kg wet weight (range: 2.1–5.4). Conclusion This study demonstrates that high-spatial resolution PRESS EPSI of the muscle lipids is feasible on standard clinical scanners. PMID:24498129

Applying the Trigger Review Method after a brief educational intervention: potential for teaching and improving safety in GP specialty training?

PubMed

McKay, John; de Wet, Carl; Kelly, Moya; Bowie, Paul

2013-08-30

The Trigger Review Method (TRM) is a structured approach to screening clinical records for undetected patient safety incidents (PSIs) and identifying learning and improvement opportunities. In Scotland, TRM participation can inform GP appraisal and has been included as a core component of the national primary care patient safety programme that was launched in March 2013. However, the clinical workforce needs up-skilled and the potential of TRM in GP training has yet to be tested. Current TRM training utilizes a workplace face-to-face session by a GP expert, which is not feasible. A less costly, more sustainable educational intervention is necessary to build capability at scale. We aimed to determine the feasibility and impact of TRM and a related training intervention in GP training. We recruited 25 west of Scotland GP trainees to attend a 2-hour TRM workshop. Trainees then applied TRM to 25 clinical records and returned findings within 4-weeks. A follow-up feedback workshop was held. 21/25 trainees (84%) completed the task. 520 records yielded 80 undetected PSIs (15.4%). 36/80 were judged potentially preventable (45%) with 35/80 classified as causing moderate to severe harm (44%). Trainees described a range of potential learning and improvement plans. Training was positively received and appeared to be successful given these findings. TRM was valued as a safety improvement tool by most participants. This small study provides further evidence of TRM utility and how to teach it pragmatically. TRM is of potential value in GP patient safety curriculum delivery and preparing trainees for future safety improvement expectations.

[A new kinematics method of determing elbow rotation axis and evaluation of its feasibility].

PubMed

Han, W; Song, J; Wang, G Z; Ding, H; Li, G S; Gong, M Q; Jiang, X Y; Wang, M Y

2016-04-18

To study a new positioning method of elbow external fixation rotation axis, and to evaluate its feasibility. Four normal adult volunteers and six Sawbone elbow models were brought into this experiment. The kinematic data of five elbow flexion were collected respectively by optical positioning system. The rotation axes of the elbow joints were fitted by the least square method. The kinematic data and fitting results were visually displayed. According to the fitting results, the average moving planes and rotation axes were calculated. Thus, the rotation axes of new kinematic methods were obtained. By using standard clinical methods, the entrance and exit points of rotation axes of six Sawbone elbow models were located under X-ray. And The kirschner wires were placed as the representatives of rotation axes using traditional positioning methods. Then, the entrance point deviation, the exit point deviation and the angle deviation of two kinds of located rotation axes were compared. As to the four volunteers, the indicators represented circular degree and coplanarity of elbow flexion movement trajectory of each volunteer were both about 1 mm. All the distance deviations of the moving axes to the average moving rotation axes of the five volunteers were less than 3 mm. All the angle deviations of the moving axes to the average moving rotation axes of the five volunteers were less than 5°. As to the six Sawbone models, the average entrance point deviations, the average exit point deviations and the average angle deviations of two different rotation axes determined by two kinds of located methods were respectively 1.697 2 mm, 1.838 3 mm and 1.321 7°. All the deviations were very small. They were all in an acceptable range of clinical practice. The values that represent circular degree and coplanarity of volunteer's elbow single curvature movement trajectory are very small. The result shows that the elbow single curvature movement can be regarded as the approximate fixed axis movement. The new method can replace the traditional method in accuracy. It can make up the deficiency of the traditional fixed axis method.

Beyond the false negative rate: development of quality indicators for sentinel lymph node biopsy in breast cancer.

PubMed

Quan, May Lynn; Wells, Bryan J; McCready, David; Wright, Frances C; Fraser, Novlette; Gagliardi, Anna R

2010-02-01

Sentinel lymph node biopsy (SNLB) has been adopted as the standard method of axillary staging for women with clinically node-negative early-stage breast cancer. The false negative rate as a quality indicator is impractical given the need for a completion axillary dissection to calculate. The objective of this study was to develop practical quality indicators for SLNB using an expert consensus method and to determine if they were feasible to measure. We used a modified Delphi consensus process to develop quality indicators for SLNB. A multidisciplinary expert panel reviewed potential indicators extracted from the medical literature to select quality indicators that were relevant and measurable. Feasibility was determined by abstracting the quality indicator variables from a retrospective chart review. The expert panel prioritized 11 quality indicators as benchmarks for assessing the quality of surgical care in SNLB. Nine of the indicators were measurable at the chart or institutional level. A systematic evidence- and consensus-based approach was used to develop measurable quality indicators that could be used by practicing surgeons and administrators to evaluate performance of SLNB in breast cancer.

Dermatological Feasibility of Multimodal Facial Color Imaging Modality for Cross-Evaluation of Facial Actinic Keratosis

PubMed Central

Bae, Youngwoo; Son, Taeyoon; Nelson, J. Stuart; Kim, Jae-Hong; Choi, Eung Ho; Jung, Byungjo

2010-01-01

Background/Purpose Digital color image analysis is currently considered as a routine procedure in dermatology. In our previous study, a multimodal facial color imaging modality (MFCIM), which provides a conventional, parallel- and cross-polarization, and fluorescent color image, was introduced for objective evaluation of various facial skin lesions. This study introduces a commercial version of MFCIM, DermaVision-PRO, for routine clinical use in dermatology and demonstrates its dermatological feasibility for cross-evaluation of skin lesions. Methods/Results Sample images of subjects with actinic keratosis or non-melanoma skin cancers were obtained at four different imaging modes. Various image analysis methods were applied to cross-evaluate the skin lesion and, finally, extract valuable diagnostic information. DermaVision-PRO is potentially a useful tool as an objective macroscopic imaging modality for quick prescreening and cross-evaluation of facial skin lesions. Conclusion DermaVision-PRO may be utilized as a useful tool for cross-evaluation of widely distributed facial skin lesions and an efficient database management of patient information. PMID:20923462

SU-G-TeP4-02: A Method for Evaluating the Direct Impact of Failed IMRT QAs On Patient Dose

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

Geneser, S; Butkus, M

Purpose: We developed a method to calculate patient doses corresponding to IMRT QA measurements in order to determine and assess the actual dose delivered for plans with failed (or borderline) IMRT QA. This work demonstrates the feasibility of automatically computing delivered patient dose from portal dosimetry measurements in the Varian TPS system, which would provide a valuable and clinically viable IMRT QA tool for physicists and physicians. Methods: IMRT QA fluences were measured using portal dosimetry, processed using in-house matlab software, and imported back into Eclipse to calculate dose on the planning CT. To validate the proposed workflow, the Eclipsemore » calculated portal dose for a 5-field sliding window prostate boost plan was processed as described above. The resulting dose was compared to the planned dose and found to be within 0.5 Gy. Two IMRT QA results for the prostate boost plan (one that failed and one that passed) were processed and the resulting patient doses were evaluated. Results: The max dose difference between IMRT QA #1 and the original planned and approved dose is 4.5 Gy, while the difference between the planned and IMRT QA #2 dose is 4.0 Gy. The inferior portion of the PTV is slightly underdosed in both plans, and the superior portion is slightly overdosed. The patient dose resulting from IMRT QA #1 and #2 differs by only 0.5 Gy. With this new information, it may be argued that the evaluated plan alteration to obtain passing gamma analysis produced clinically irrelevant differences. Conclusion: Evaluation of the delivered QA dose on the planning CT provides valuable information about the clinical relevance of failed or borderline IMRT QAs. This particular workflow demonstrates the feasibility of pushing the measured IMRT QA portal dosimetry results directly back onto the patient planning CT within the Varian system.« less

Data quality and feasibility of the Experience Sampling Method across the spectrum of severe psychiatric disorders: a protocol for a systematic review and meta-analysis.

PubMed

Vachon, Hugo; Rintala, Aki; Viechtbauer, Wolfgang; Myin-Germeys, Inez

2018-01-18

Due to a number of methodological advantages and theoretical considerations, more and more studies in clinical psychology research employ the Experience Sampling Method (ESM) as a data collection technique. Despite this growing interest, the absence of methodological guidelines related to the use of ESM has resulted in a large heterogeneity of designs while the potential effects of the design itself on the response behavior of the participants remain unknown. The objectives of this systematic review are to investigate the associations between the design characteristics and the data quality and feasibility of studies relying on ESM in severe psychiatric disorders. We will search for all published studies using ambulatory assessment with patients suffering from major depressive disorder, bipolar disorder, and psychotic disorder or individuals at high risk for these disorders. Electronic database searches will be performed in PubMed and Web of Science with no restriction on the publication date. Two reviewers will independently screen original studies in a title/abstract phase and a full-text phase based on the inclusion criteria. The information related to the design and sample characteristics, data quality, and feasibility will be extracted. We will provide results in terms of a descriptive synthesis, and when applicable, a meta-analysis of the findings will be conducted. Our results will attempt to highlight how the feasibility and data quality of ambulatory assessment might be related to the methodological characteristics of the study designs in severe psychiatric disorders. We will discuss these associations in different subsamples if sufficient data are available and will examine limitations in the reporting of the methods of ambulatory studies in the current literature. The protocol for this systematic review was registered on PROSPERO (PROSPERO 2017: CRD42017060322 ) and is available in full on the University of York website ( http://www.crd.york.ac.uk/PROSPERO/display_record.asp?ID=CRD42017060322 ).

A clinically guided approach for improving performance measurement for hypertension.

PubMed

Steinman, Michael A; Lee, Sei J; Peterson, Carolyn A; Fung, Kathy Z; Goldstein, Mary K

2012-05-01

Performance measures often fail to account for legitimate reasons why patients do not achieve recommended treatment targets. We tested a novel performance measurement system for blood pressure (BP) control that was designed to mimic clinical reasoning. This clinically guided approach focuses on (1) exempting patients for whom tight BP control may not be appropriate or feasible and (2) assessing BP over time. Trained abstractors conducted structured chart reviews of 201 adults with hypertension in 2 VA health care systems. Results were compared with traditional methods of performance measurement. Among 201 veterans, 183 (91%) were male, and the mean age was 71±11 years. Using the clinically guided approach, 61 patients (30%) were exempted from performance measurement. The most common reasons for exemption were inadequate opportunity to manage BP (35 patients, 17%) and the use of 4 or more antihypertensive medications (19 patients, 9%). Among patients eligible for performance measurement, there was little agreement on the presence of controlled versus uncontrolled BP when comparing the most recent BP (the traditional approach) with an integrated assessment of BP control (κ 0.14). After accounting for clinically guided exemptions and methods of BP assessment, only 15 of 72 patients (21%) whose last BP was ≥140/90 mm Hg were classified as problematic by the clinically guided approach. Many patients have legitimate reasons for not achieving tight BP control, and the methods used for BP assessment have marked effects on whether a patient is classified as having adequate or inadequate BP control.

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

Ranganathan, V; Kumar, P; Bzdusek, K

Purpose: We propose a novel data-driven method to predict the achievability of clinical objectives upfront before invoking the IMRT optimization. Methods: A new metric called “Geometric Complexity (GC)” is used to estimate the achievability of clinical objectives. Here, GC is the measure of the number of “unmodulated” beamlets or rays that intersect the Region-of-interest (ROI) and the target volume. We first compute the geometric complexity ratio (GCratio) between the GC of a ROI (say, parotid) in a reference plan and the GC of the same ROI in a given plan. The GCratio of a ROI indicates the relative geometric complexitymore » of the ROI as compared to the same ROI in the reference plan. Hence GCratio can be used to predict if a defined clinical objective associated with the ROI can be met by the optimizer for a given case. Basically a higher GCratio indicates a lesser likelihood for the optimizer to achieve the clinical objective defined for a given ROI. Similarly, a lower GCratio indicates a higher likelihood for the optimizer to achieve the clinical objective defined for the given ROI. We have evaluated the proposed method on four Head and Neck cases using Pinnacle3 (version 9.10.0) Treatment Planning System (TPS). Results: Out of the total of 28 clinical objectives from four head and neck cases included in the study, 25 were in agreement with the prediction, which implies an agreement of about 85% between predicted and obtained results. The Pearson correlation test shows a positive correlation between predicted and obtained results (Correlation = 0.82, r2 = 0.64, p < 0.005). Conclusion: The study demonstrates the feasibility of the proposed method in head and neck cases for predicting the achievability of clinical objectives with reasonable accuracy.« less

Working towards consensus on methods used to elicit participant-reported safety data in uncomplicated malaria clinical drug studies: a Delphi technique study.

PubMed

Mandimika, Nyaradzo; Barnes, Karen I; Chandler, Clare I R; Pace, Cheryl; Allen, Elizabeth N

2017-01-28

Eliciting adverse event (AE) and non-study medication data reports from clinical research participants is integral to evaluating drug safety. However, using different methods to question participants yields inconsistent results, compromising the interpretation, comparison and pooling of data across studies. This is particularly important given the widespread use of anti-malarials in vulnerable populations, and their increasing use in healthy, but at-risk individuals, as preventive treatment or to reduce malaria transmission. Experienced and knowledgeable anti-malarial drug clinical researchers were invited to participate in a Delphi technique study, to facilitate consensus on what are considered optimal (relevant, important and feasible) methods, tools, and approaches for detecting participant-reported AE and non-study medication data in uncomplicated malaria treatment studies. Of 72 invited, 25, 16 and 10 panellists responded to the first, second and third rounds of the Delphi, respectively. Overall, 68% (68/100) of all questioning items presented for rating achieved consensus. When asking general questions about health, panellists agreed on the utility of a question/concept about any change in health, taking care to ensure that such questions/concepts do not imply causality. Eighty-nine percent (39/44) of specific signs and symptoms questions were rated as optimal. For non-study medications, a general question and most structured questioning items were considered an optimal approach. The use of mobile phones, patient diaries, rating scales as well as openly engaging with participants to discuss concerns were also considered optimal complementary data-elicitation tools. This study succeeded in reaching consensus within a section of the anti-malarial drug clinical research community about using a general question concept, and structured questions for eliciting data about AEs and non-study medication reports. The concepts and items considered in this Delphi to be relevant, important and feasible should be further investigated for potential inclusion in a harmonized approach to collect participant-elicited anti-malarial drug safety data. This, in turn, should improve understanding of anti-malarial drug safety.

Automated Detection of Actinic Keratoses in Clinical Photographs

PubMed Central

Hames, Samuel C.; Sinnya, Sudipta; Tan, Jean-Marie; Morze, Conrad; Sahebian, Azadeh; Soyer, H. Peter; Prow, Tarl W.

2015-01-01

Background Clinical diagnosis of actinic keratosis is known to have intra- and inter-observer variability, and there is currently no non-invasive and objective measure to diagnose these lesions. Objective The aim of this pilot study was to determine if automatically detecting and circumscribing actinic keratoses in clinical photographs is feasible. Methods Photographs of the face and dorsal forearms were acquired in 20 volunteers from two groups: the first with at least on actinic keratosis present on the face and each arm, the second with no actinic keratoses. The photographs were automatically analysed using colour space transforms and morphological features to detect erythema. The automated output was compared with a senior consultant dermatologist’s assessment of the photographs, including the intra-observer variability. Performance was assessed by the correlation between total lesions detected by automated method and dermatologist, and whether the individual lesions detected were in the same location as the dermatologist identified lesions. Additionally, the ability to limit false positives was assessed by automatic assessment of the photographs from the no actinic keratosis group in comparison to the high actinic keratosis group. Results The correlation between the automatic and dermatologist counts was 0.62 on the face and 0.51 on the arms, compared to the dermatologist’s intra-observer variation of 0.83 and 0.93 for the same. Sensitivity of automatic detection was 39.5% on the face, 53.1% on the arms. Positive predictive values were 13.9% on the face and 39.8% on the arms. Significantly more lesions (p<0.0001) were detected in the high actinic keratosis group compared to the no actinic keratosis group. Conclusions The proposed method was inferior to assessment by the dermatologist in terms of sensitivity and positive predictive value. However, this pilot study used only a single simple feature and was still able to achieve sensitivity of detection of 53.1% on the arms.This suggests that image analysis is a feasible avenue of investigation for overcoming variability in clinical assessment. Future studies should focus on more sophisticated features to improve sensitivity for actinic keratoses without erythema and limit false positives associated with the anatomical structures on the face. PMID:25615930

A feasible, economical, and accurate analytical method for simultaneous determination of six alkaloid markers in Aconiti Lateralis Radix Praeparata from different manufacturing sources and processing ways.

PubMed

Zhang, Yi-Bei; DA, Juan; Zhang, Jing-Xian; Li, Shang-Rong; Chen, Xin; Long, Hua-Li; Wang, Qiu-Rong; Cai, Lu-Ying; Yao, Shuai; Hou, Jin-Jun; Wu, Wan-Ying; Guo, De-An

2017-04-01

Aconiti Lateralis Radix Praeparata (Fuzi) is a commonly used traditional Chinese medicine in clinic for its potency in restoring yang and rescuing from collapse. Aconiti alkaloids, mainly including monoester-diterpenoidaconitines (MDAs) and diester-diterpenoidaconitines (DDAs), are considered to act as both bioactive and toxic constituents. In the present study, a feasible, economical, and accurate HPLC method for simultaneous determination of six alkaloid markers using the Single Standard for Determination of Multi-Components (SSDMC) method was developed and fully validated. Benzoylmesaconine was used as the unique reference standard. This method was proven as accurate (recovery varying between 97.5%-101.8%, RSD < 3%), precise (RSD 0.63%-2.05%), and linear (R > 0.999 9) over the concentration ranges, and subsequently applied to quantitative evaluation of 62 batches of samples, among which 45 batches were from good manufacturing practice (GMP) facilities and 17 batches from the drug market. The contents were then analyzed by principal component analysis (PCA) and homogeneity test. The present study provided valuable information for improving the quality standard of Aconiti Lateralis Radix Praeparata. The developed method also has the potential in analysis of other Aconitum species, such as Aconitum carmichaelii (prepared parent root) and Aconitum kusnezoffii (prepared root). Copyright © 2017 China Pharmaceutical University. Published by Elsevier B.V. All rights reserved.

Diffuse optical tomography and spectroscopy of breast cancer and fetal brain

NASA Astrophysics Data System (ADS)

Choe, Regine

Diffuse optical techniques utilize light in the near infrared spectral range to measure tissue physiology non-invasively. Based on these measurements, either on average or a three-dimensional spatial map of tissue properties such as total hemoglobin concentration, blood oxygen saturation and scattering can be obtained using model-based reconstruction algorithms. In this thesis, diffuse optical techniques were applied for in vivo breast cancer imaging and trans-abdominal fetal brain oxygenation monitoring. For in vivo breast cancer imaging, clinical diffuse optical tomography and related instrumentation was developed and used in several contexts. Bulk physiological properties were quantified for fifty-two healthy subjects in the parallel-plate transmission geometry. Three-dimensional images of breast were reconstructed for subjects with breast tumors and, tumor contrast with respect to normal tissue was found in total hemoglobin concentration and scattering and was quantified for twenty-two breast carcinomas. Tumor contrast and tumor volume changes during neoadjuvant chemotherapy were tracked for one subject and compared to the dynamic contrast-enhanced MRI. Finally, the feasibility for measuring blood flow of breast tumors using optical methods was demonstrated for seven subjects. In a qualitatively different set of experiments, the feasibility for trans-abdominal fetal brain oxygenation monitoring was demonstrated on pregnant ewes with induced fetal hypoxia. Preliminary clinical experiences were discussed to identify future directions. In total, this research has translated diffuse optical tomography techniques into clinical research environment.

Development and Validation of the Diabetes Adolescent Problem Solving Questionnaire

PubMed Central

Mulvaney, Shelagh A.; Jaser, Sarah S.; Rothman, Russell L.; Russell, William; Pittel, Eric J.; Lybarger, Cindy; Wallston, Kenneth A.

2014-01-01

Objective Problem solving is a critical diabetes self-management skill. Because of a lack of clinically feasible measures, our aim was to develop and validate a self-report self-management problem solving questionnaire for adolescents with type 1 diabetes (T1D). Methods A multidisciplinary team of diabetes experts generated questionnaire items that addressed diabetes self-management problem solving. Iterative feedback from parents and adolescents resulted in 27 items. Adolescents from two studies (N=156) aged 13–17 were recruited through a pediatric diabetes clinic and completed measures through an online survey. Glycemic control was measured by HbA1c recorded in the medical record. Results Empirical elimination of items using Principal Components Analyses resulted in a 13-item unidimensional measure, the Diabetes Adolescent Problem Solving Questionnaire (DAPSQ) that explained 57% of the variance. The DAPSQ demonstrated internal consistency (Cronbach’s alpha = 0.92) and was correlated with diabetes self-management (r=0.53, p<.001), self-efficacy (r=0.54, p<.001), and glycemic control (r= −0.24, p<.01). Conclusion The DAPSQ is a brief instrument for assessment of diabetes self-management problem solving in youth with T1D associated with better self-management behaviors and glycemic control. Practice Implications The DAPSQ is a clinically feasible self-report measure that can provide valuable information regarding level of self-management problem solving and guide patient education. PMID:25063715

Leveraging biodiversity knowledge for potential phyto-therapeutic applications

PubMed Central

Sharma, Vivekanand; Sarkar, Indra Neil

2013-01-01

Objective To identify and highlight the feasibility, challenges, and advantages of providing a cross-domain pipeline that can link relevant biodiversity information for phyto-therapeutic assessment. Materials and methods A public repository of clinical trials information (ClinicalTrials.gov) was explored to determine the state of plant-based interventions under investigation. Results The results showed that ∼15% of drug interventions in ClinicalTrials.gov were potentially plant related, with about 60% of them clustered within 10 taxonomic families. Further analysis of these plant-based interventions identified ∼3.7% of associated plant species as endangered as determined from the International Union for the Conservation of Nature Red List. Discussion The diversity of the plant kingdom has provided human civilization with life-sustaining food and medicine for centuries. There has been renewed interest in the investigation of botanicals as sources of new drugs, building on traditional knowledge about plant-based medicines. However, data about the plant-based biodiversity potential for therapeutics (eg, based on genetic or chemical information) are generally scattered across a range of sources and isolated from contemporary pharmacological resources. This study explored the potential to bridge biodiversity and biomedical knowledge sources. Conclusions The findings from this feasibility study suggest that there is an opportunity for developing plant-based drugs and further highlight taxonomic relationships between plants that may be rich sources for bioprospecting. PMID:23518859

Transcontinental anaesthesia: a pilot study.

PubMed

Hemmerling, T M; Arbeid, E; Wehbe, M; Cyr, S; Giunta, F; Zaouter, C

2013-05-01

Although telemedicine is one of the key initiatives of the World Health Organization, no study has explored the feasibility and efficacy of teleanaesthesia. This bi-centre pilot study investigates the feasibility of transcontinental anaesthesia. Twenty patients aged ≥ 18 yr undergoing elective thyroid surgery for ≥ 30 min were enrolled in this study. The remote and local set-up was composed of a master-computer (Montreal) and a slave-computer (Pisa). Standard Internet connection, remote desktop control, and video conference software were used. All patients received total i.v. anaesthesia controlled remotely (Montreal). The main outcomes were feasibility, clinical performance, and controller performance of transcontinental anaesthesia. The clinical performance of hypnosis control was the efficacy to maintain bispectral index (BIS) at 45: 'excellent', 'good', 'poor', and 'inadequate' control represented BIS values within 10, from 11 to 20, from 21 to 30, or >30% from target. The clinical performance of analgesia was the efficacy to maintain Analgoscore values at 0 (-9 to 9); -3 to +3 representing 'excellent' pain control, -3 to -6 and +3 to +6 representing 'good' pain control, and -6 to -9 and +6 to +9 representing 'insufficient' pain control. The controller performance was evaluated using Varvel parameters. Transcontinental anaesthesia was successful in all 20 consecutive patients. The clinical performance of hypnosis showed an 'excellent and good' control for 69% of maintenance time, and the controller performance showed an average global performance index of 57. The clinical performance of analgesia was 'excellent and good' for 92% of maintenance time, and the controller performance showed a global performance index of 1118. Transcontinental anaesthesia is feasible; control of anaesthesia shows good performance indexes. Clinical registration number NCT01331096.

Evaluation of a pilot parent-delivered play-based intervention for children with attention deficit hyperactivity disorder.

PubMed

Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle

2014-01-01

OBJECTIVE. This study evaluated a parent-delivered intervention aiming to address the social difficulties of children with attention deficit hyperactivity disorder (ADHD). The intervention was evaluated from three perspectives: effectiveness, feasibility, and appropriateness. METHOD. This one-group pretest-posttest study included 5 children with ADHD and their parents, who had previously participated in a therapist-delivered play-based intervention. The 7-wk parent-delivered intervention involved home modules (including a DVD, manual, and play dates with a typically developing playmate) and three therapist-led clinic-based play sessions. The Test of Playfulness was used as a pre- and postintervention and follow-up measure. Parents were interviewed 1 mo following the intervention, and data were analyzed for recurring themes. RESULTS. Children's social play outcomes improved significantly from pretest to 1-mo follow-up (Z = 2.02, p = .04, d = 1.0). Three themes emerged: the clinic play environment as a sanctuary, parental barriers to intervention delivery, and tools for repeating learned lessons. CONCLUSION. The parent-delivered intervention demonstrated preliminary evidence for feasibility and effectiveness. Further research is warranted regarding appropriateness. Copyright © 2014 by the American Occupational Therapy Association, Inc.

POTENTIAL EFFECTS OF WHOLE-BODY VIBRATION EXERCISES ON BLOOD FLOW KINETICS OF DIFFERENT POPULATIONS: A SYSTEMATIC REVIEW WITH A SUITABLE APPROACH

PubMed Central

Sá-Caputo, Danúbia; Paineiras-Domingos, Laisa; Carvalho-Lima, Rafaelle; Dias-Costa, Glenda; de Paiva, Patrícia de Castro; de Azeredo, Claudia Figueiredo; Carmo, Roberto Carlos Resende; Dionello, Carla F.; Moreira-Marconi, Eloá; Frederico, Éric Heleno F.F.; Sousa-Gonçalves, Cintia Renata; Morel, Danielle S.; Paiva, Dulciane N.; Avelar, Núbia C.P.; Lacerda, Ana C.; Magalhães, Carlos E.V.; Castro, Leonardo S.; Presta, Giuseppe A.; de Paoli, Severo; Sañudo, Borja; Bernardo-Filho, Mario

2017-01-01

Background: The ability to control skin blood flow decreases with advancing age and some clinical disorders, as in diabetes and in rheumatologic diseases. Feasible clinical strategies such as whole-body vibration exercise (WBVE) are being used without a clear understanding of its effects. The aim of the present study is to review the effects of the WBVE on blood flow kinetics and its feasibility in different populations. Material and Methods: The level of evidence (LE) of selected papers in PubMed and/or PEDRo databases was determined. We selected randomized, controlled trials in English to be evaluated. Results: Six studies had LE II, one had LE III-2 and one III-3 according to the NHMRC. A great variability among the protocols was observed but also in the assessment devices; therefore, more research about this topic is warranted. Conclusion: Despite the limitations, it is can be concluded that the use of WBVE has proven to be a safe and useful strategy to improve blood flow. However, more studies with greater methodological quality are needed to clearly define the more suitable protocols. PMID:28740943

A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention.

PubMed

Zardouz, Shawn; Shi, Lei; Leung, Albert

2016-01-01

This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura). Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval) delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4-2.8) in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

Use of ferrets for electrophysiologic monitoring of ion transport

PubMed Central

Kaza, Niroop; Raju, S. Vamsee; Cadillac, Joan M.; Trombley, John A.; Rasmussen, Lawrence; Tang, Liping; Dohm, Erik; Harrod, Kevin S.

2017-01-01

Limited success achieved in translating basic science discoveries into clinical applications for chronic airway diseases is attributed to differences in respiratory anatomy and physiology, poor approximation of pathologic processes, and lack of correlative clinical endpoints between humans and laboratory animal models. Here, we discuss advantages of using ferrets (Mustela putorus furo) as a model for improved understanding of human airway physiology and demonstrate assays for quantifying airway epithelial ion transport in vivo and ex vivo, and establish air-liquid interface cultures of ferret airway epithelial cells as a complementary in vitro model for mechanistic studies. We present data here that establishes the feasibility of measuring these human disease endpoints in ferrets. Briefly, potential difference across the nasal and the lower airway epithelium in ferrets could be consistently assessed, were highly reproducible, and responsive to experimental interventions. Additionally, ferret airway epithelial cells were amenable to primary cell culture methods for in vitro experiments as was the use of ferret tracheal explants as an ex vivo system for assessing ion transport. The feasibility of conducting multiple assessments of disease outcomes supports the adoption of ferrets as a highly relevant model for research in obstructive airway diseases. PMID:29077751

Surgical stent planning: simulation parameter study for models based on DICOM standards.

PubMed

Scherer, S; Treichel, T; Ritter, N; Triebel, G; Drossel, W G; Burgert, O

2011-05-01

Endovascular Aneurysm Repair (EVAR) can be facilitated by a realistic simulation model of stent-vessel-interaction. Therefore, numerical feasibility and integrability in the clinical environment was evaluated. The finite element method was used to determine necessary simulation parameters for stent-vessel-interaction in EVAR. Input variables and result data of the simulation model were examined for their standardization using DICOM supplements. The study identified four essential parameters for the stent-vessel simulation: blood pressure, intima constitution, plaque occurrence and the material properties of vessel and plaque. Output quantities such as radial force of the stent and contact pressure between stent/vessel can help the surgeon to evaluate implant fixation and sealing. The model geometry can be saved with DICOM "Surface Segmentation" objects and the upcoming "Implant Templates" supplement. Simulation results can be stored using the "Structured Report". A standards-based general simulation model for optimizing stent-graft selection may be feasible. At present, there are limitations due to specification of individual vessel material parameters and for simulating the proximal fixation of stent-grafts with hooks. Simulation data with clinical relevance for documentation and presentation can be stored using existing or new DICOM extensions.

Use of ferrets for electrophysiologic monitoring of ion transport.

PubMed

Kaza, Niroop; Raju, S Vamsee; Cadillac, Joan M; Trombley, John A; Rasmussen, Lawrence; Tang, Liping; Dohm, Erik; Harrod, Kevin S; Rowe, Steven M

2017-01-01

Limited success achieved in translating basic science discoveries into clinical applications for chronic airway diseases is attributed to differences in respiratory anatomy and physiology, poor approximation of pathologic processes, and lack of correlative clinical endpoints between humans and laboratory animal models. Here, we discuss advantages of using ferrets (Mustela putorus furo) as a model for improved understanding of human airway physiology and demonstrate assays for quantifying airway epithelial ion transport in vivo and ex vivo, and establish air-liquid interface cultures of ferret airway epithelial cells as a complementary in vitro model for mechanistic studies. We present data here that establishes the feasibility of measuring these human disease endpoints in ferrets. Briefly, potential difference across the nasal and the lower airway epithelium in ferrets could be consistently assessed, were highly reproducible, and responsive to experimental interventions. Additionally, ferret airway epithelial cells were amenable to primary cell culture methods for in vitro experiments as was the use of ferret tracheal explants as an ex vivo system for assessing ion transport. The feasibility of conducting multiple assessments of disease outcomes supports the adoption of ferrets as a highly relevant model for research in obstructive airway diseases.

Feasibility of Rehabilitation Training With a Newly Developed, Portable, Gait Assistive Robot for Balance Function in Hemiplegic Patients

PubMed Central

2017-01-01

Objective To investigate the clinical feasibility of a newly developed, portable, gait assistive robot (WA-H, ‘walking assist for hemiplegia’) for improving the balance function of patients with stroke-induced hemiplegia. Methods Thirteen patients underwent 12 weeks of gait training on the treadmill while wearing WA-H for 30 minutes per day, 4 days a week. Patients' balance function was evaluated by the Berg Balance Scale (BBS), Fugl-Meyer Assessment Scale (FMAS), Timed Up and Go Test (TUGT), and Short Physical Performance Battery (SPPB) before and after 6 and 12 weeks of training. Results There were no serious complications or clinical difficulties during gait training with WA-H. In three categories of BBS, TUGT, and the balance scale of SPPB, there was a statistically significant improvement at the 6th week and 12th week of gait training with WA-H. In the subscale of balance function of FMAS, there was statistically significant improvement only at the 12th week. Conclusion Gait training using WA-H demonstrated a beneficial effect on balance function in patients with hemiplegia without a safety issue. PMID:28503449

Enhancing pediatric clinical trial feasibility through the use of Bayesian statistics.

PubMed

Huff, Robin A; Maca, Jeff D; Puri, Mala; Seltzer, Earl W

2017-11-01

BackgroundPediatric clinical trials commonly experience recruitment challenges including limited number of patients and investigators, inclusion/exclusion criteria that further reduce the patient pool, and a competitive research landscape created by pediatric regulatory commitments. To overcome these challenges, innovative approaches are needed.MethodsThis article explores the use of Bayesian statistics to improve pediatric trial feasibility, using pediatric Type-2 diabetes as an example. Data for six therapies approved for adults were used to perform simulations to determine the impact on pediatric trial size.ResultsWhen the number of adult patients contributing to the simulation was assumed to be the same as the number of patients to be enrolled in the pediatric trial, the pediatric trial size was reduced by 75-78% when compared with a frequentist statistical approach, but was associated with a 34-45% false-positive rate. In subsequent simulations, greater control was exerted over the false-positive rate by decreasing the contribution of the adult data. A 30-33% reduction in trial size was achieved when false-positives were held to less than 10%.ConclusionReducing the trial size through the use of Bayesian statistics would facilitate completion of pediatric trials, enabling drugs to be labeled appropriately for children.

A feasible DY conjugate gradient method for linear equality constraints

NASA Astrophysics Data System (ADS)

LI, Can

2017-09-01

In this paper, we propose a feasible conjugate gradient method for solving linear equality constrained optimization problem. The method is an extension of the Dai-Yuan conjugate gradient method proposed by Dai and Yuan to linear equality constrained optimization problem. It can be applied to solve large linear equality constrained problem due to lower storage requirement. An attractive property of the method is that the generated direction is always feasible and descent direction. Under mild conditions, the global convergence of the proposed method with exact line search is established. Numerical experiments are also given which show the efficiency of the method.

Adaptive clinical trial design.

PubMed

Chow, Shein-Chung

2014-01-01

In recent years, the use of adaptive design methods in clinical trials based on accumulated data at interim has received much attention because of its flexibility and efficiency in pharmaceutical/clinical development. In practice, adaptive design may provide the investigators a second chance to modify or redesign the trial while the study is still ongoing. However, it is a concern that a shift in target patient population may occur after significant adaptations are made. In addition, the overall type I error rate may not be preserved. Moreover, the results may not be reliable and hence are difficult to interpret. As indicated by the US Food and Drug Administration draft guidance on adaptive design clinical trials, the adaptive design has to be a prospectively planned opportunity and should be based on information collected within the study, with or without formal statistical hypothesis testing. This article reviews the relative advantages, limitations, and feasibility of commonly considered adaptive designs in clinical trials. Statistical concerns when implementing adaptive designs are also discussed.

The utility of Bayesian predictive probabilities for interim monitoring of clinical trials

PubMed Central

Connor, Jason T.; Ayers, Gregory D; Alvarez, JoAnn

2014-01-01

Background Bayesian predictive probabilities can be used for interim monitoring of clinical trials to estimate the probability of observing a statistically significant treatment effect if the trial were to continue to its predefined maximum sample size. Purpose We explore settings in which Bayesian predictive probabilities are advantageous for interim monitoring compared to Bayesian posterior probabilities, p-values, conditional power, or group sequential methods. Results For interim analyses that address prediction hypotheses, such as futility monitoring and efficacy monitoring with lagged outcomes, only predictive probabilities properly account for the amount of data remaining to be observed in a clinical trial and have the flexibility to incorporate additional information via auxiliary variables. Limitations Computational burdens limit the feasibility of predictive probabilities in many clinical trial settings. The specification of prior distributions brings additional challenges for regulatory approval. Conclusions The use of Bayesian predictive probabilities enables the choice of logical interim stopping rules that closely align with the clinical decision making process. PMID:24872363

Assessment of Free Dye in Solutions of Dual-Labeled Antibody Conjugates for In Vivo Molecular Imaging

PubMed Central

Aldrich, Melissa B.; Wang, XueJuan; Hart, Amy; Sampath, Lakshmi; Marshall, Milton V.; Sevick-Muraca, Eva M.

2017-01-01

PURPOSE Recent preclinical and clinical studies show dyes that excite and fluoresce in the near infrared range may be used for tracking and detecting disease targets in vivo. A method for quantifying free dye molecules in antibody conjugate preparations is required for agent batch release and for translation into the clinic. PROCEDURES Herein, we developed and validated a SDS-PAGE method to determine the percentage of free IRDye 800CW in (DTPA)n-trastuzumab—(IRDye 800)m conjugate sample preparations in which HPLC assessment of free dye was not possible. RESULTS The SDS-PAGE assay was accurate and valid for free IRDye 800CW amounts between 38 and 4 molar percent of total dye. Gel sample preparation reagent affected the specificity of the assay, and lower and upper limits of quantitation and detection were determined. CONCLUSION This method may be applicable to other near infrared dye-conjugated antibody-based imaging agents in which HPLC assessment of purity is not feasible. This validated method for quality assurance will facilitate the translation of dual-labeled antibody conjugates for nuclear and optical imaging. PMID:20458634

Rapid antibiotic-resistance predictions from genome sequence data for Staphylococcus aureus and Mycobacterium tuberculosis

PubMed Central

Bradley, Phelim; Gordon, N. Claire; Walker, Timothy M.; Dunn, Laura; Heys, Simon; Huang, Bill; Earle, Sarah; Pankhurst, Louise J.; Anson, Luke; de Cesare, Mariateresa; Piazza, Paolo; Votintseva, Antonina A.; Golubchik, Tanya; Wilson, Daniel J.; Wyllie, David H.; Diel, Roland; Niemann, Stefan; Feuerriegel, Silke; Kohl, Thomas A.; Ismail, Nazir; Omar, Shaheed V.; Smith, E. Grace; Buck, David; McVean, Gil; Walker, A. Sarah; Peto, Tim E. A.; Crook, Derrick W.; Iqbal, Zamin

2015-01-01

The rise of antibiotic-resistant bacteria has led to an urgent need for rapid detection of drug resistance in clinical samples, and improvements in global surveillance. Here we show how de Bruijn graph representation of bacterial diversity can be used to identify species and resistance profiles of clinical isolates. We implement this method for Staphylococcus aureus and Mycobacterium tuberculosis in a software package (‘Mykrobe predictor') that takes raw sequence data as input, and generates a clinician-friendly report within 3 minutes on a laptop. For S. aureus, the error rates of our method are comparable to gold-standard phenotypic methods, with sensitivity/specificity of 99.1%/99.6% across 12 antibiotics (using an independent validation set, n=470). For M. tuberculosis, our method predicts resistance with sensitivity/specificity of 82.6%/98.5% (independent validation set, n=1,609); sensitivity is lower here, probably because of limited understanding of the underlying genetic mechanisms. We give evidence that minor alleles improve detection of extremely drug-resistant strains, and demonstrate feasibility of the use of emerging single-molecule nanopore sequencing techniques for these purposes. PMID:26686880

New monitoring technology to objectively assess adherence to prescribed footwear and assistive devices during ambulatory activity.

PubMed

Bus, Sicco A; Waaijman, Roelof; Nollet, Frans

2012-11-01

To assess the validity and feasibility of a new temperature-based adherence monitor to measure footwear use. Observational study. University medical center and participants' homes. Convenience sample of healthy subjects (n=11) and neuropathic diabetic patients at high risk for foot ulceration (n=14). In healthy subjects, the validity of the in-shoe attached adherence monitor was investigated by comparing its registrations of donning and doffing of footwear during 7 days to an accurately kept log registration. In diabetic patients, the feasibility of using the adherence monitor for 7 days in conjunction with a time-synchronized ankle-worn step activity monitor to register prescribed footwear use during walking was assessed. Furthermore, a usability questionnaire was completed. For validity, the mean time difference and 95% confidence interval (CI) between moments of donning/doffing footwear recorded with the adherence monitor and in the log were calculated. For feasibility, technical performance, usability, and the percentage of steps that the footwear was worn (adherence) were assessed. The mean time difference between the adherence monitor and log recordings was 0.4 minutes (95% CI, 0.2-0.6min). One erroneous recording and 2 incomplete recordings were obtained in diabetic patients. Three patients reported discomfort with the step activity monitor, and 4 patients would not favor repeated testing. Patients used their footwear for between 9% and 99% of their walking steps. The adherence monitor shows good validity in measuring when footwear is used or not, and is, together with instrumented monitoring of walking activity, a feasible and objective method to assess treatment adherence. This method can have wide application in clinical practice and research regarding prescribed footwear and other body-worn assistive devices. Copyright © 2012 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Usability and Feasibility of a Tablet-Based Decision-Support and Integrated Record-Keeping (DESIRE) Tool in the Nurse Management of Hypertension in Rural Western Kenya

PubMed Central

Vedanthan, Rajesh; Blank, Evan; Tuikong, Nelly; Kamano, Jemima; Misoi, Lawrence; Tulienge, Deborah; Hutchinson, Claire; Ascheim, Deborah D.; Kimaiyo, Sylvester; Fuster, Valentin; Were, Martin C.

2015-01-01

Background Mobile health (mHealth) applications have recently proliferated, especially in low- and middle-income countries, complementing task-redistribution strategies with clinical decision support. Relatively few studies address usability and feasibility issues that may impact success or failure of implementation, and few have been conducted for non-communicable diseases such as hypertension. Objective To conduct iterative usability and feasibility testing of a tablet-based Decision Support and Integrated Record-keeping (DESIRE) tool, a technology intended to assist rural clinicians taking care of hypertension patients at the community level in a resource-limited setting in western Kenya. Methods Usability testing consisted of “think aloud” exercises and “mock patient encounters” with five nurses, as well as one focus group discussion. Feasibility testing consisted of semi-structured interviews of five nurses and two members of the implementation team, and one focus group discussion with nurses. Content analysis was performed using both deductive codes and significant inductive codes. Critical incidents were identified and ranked according to severity. A cause-of-error analysis was used to develop corresponding design change suggestions. Results Fifty-seven critical incidents were identified in usability testing, 21 of which were unique. The cause-of-error analysis yielded 23 design change suggestions. Feasibility themes included barriers to implementation along both human and technical axes, facilitators to implementation, provider issues, patient issues and feature requests. Conclusions This participatory, iterative human-centered design process revealed previously unaddressed usability and feasibility issues affecting the implementation of the DESIRE tool in western Kenya. In addition to well-known technical issues, we highlight the importance of human factors that can impact implementation of mHealth interventions. PMID:25612791

[Organising an investigation site: a national training reference document].

PubMed

Cornu, Catherine; David, Frédérique; Duchossoy, Luc; Hansel-Esteller, Sylvie; Bertoye, Pierre-Henri; Giacomino, Alain; Mouly, Stéphane; Diebolt, Vincent; Blazejewski, Sylvie

2014-01-01

Several surveys have shown a declining performance of French investigators in conducting clinical trials. This is partly due to insufficient and heterogeneous investigator training and site organisation. A multidisciplinary group was set up to propose solutions. We describe the tools developed to improve study site organisation. This working group was made up of clinical research experts from academia, industry, drug regulatory authorities, general practice, and consulting. Methods and tools were developed to improve site organisation. The proposed tools mainly focus on increasing investigators' awareness of their responsibilities, their research environment, the importance of a thorough feasibility analysis, and the implementation of active patient recruitment strategies. These tools should be able to improve site organisation and performances in conducting clinical trials. © 2014 Société Française de Pharmacologie et de Thérapeutique.

Developing a Tablet-Based Self-Persuasion Intervention Promoting Adolescent HPV Vaccination: Protocol for a Three-Stage Mixed-Methods Study

PubMed Central

Lee, Simon Craddock; Marks, Emily G; Persaud, Donna; Skinner, Celette Sugg; Street, Richard L; Wiebe, Deborah J; Farrell, David; Bishop, Wendy Pechero; Fuller, Sobha; Baldwin, Austin S

2016-01-01

Background Human papillomavirus (HPV)-related cancers are a significant burden on the US health care system that can be prevented through adolescent HPV vaccination. Despite guidelines recommending vaccination, coverage among US adolescents is suboptimal particularly among underserved patients (uninsured, low income, racial, and ethnic minorities) seen in safety-net health care settings. Many parents are ambivalent about the vaccine and delay making a decision or talking with a provider about it. Self-persuasion—generating one’s own arguments for a health behavior—may be particularly effective for parents who are undecided or not motivated to make a vaccine decision. Objective Through a 3-stage mixed-methods protocol, we will identify an optimal and feasible self-persuasion intervention strategy to promote adolescent HPV vaccination in safety-net clinics. Methods In Stage 1, we will define content for a tablet-based self-persuasion app by characterizing (1) parents’ self-generated arguments through cognitive interviews conducted with parents (n=50) of patients and (2) parent-provider HPV vaccine discussions through audio recordings of clinic visits (n=50). In Stage 2, we will compare the effects of the four self-persuasion intervention conditions that vary by cognitive processing level (parents verbalize vs listen to arguments) and choice of argument topics (parents choose vs are assigned topics) on parental vaccine intentions in a 2 × 2 factorial design randomized controlled trial (n=160). This proof-of-concept trial design will identify which intervention condition is optimal by quantitatively examining basic self-persuasion mechanisms (cognitive processing and choice) and qualitatively exploring parent experiences with intervention tasks. In Stage 3, we will conduct a pilot trial (n=90) in the safety-net clinics to assess feasibility of the optimal intervention condition identified in Stage 2. We will also assess its impact on parent-provider discussions. Results This paper describes the study protocol and activities to date. Currently, we have developed the initial prototype of the tablet app for English- and Spanish-speaking populations, and completed Stage 1 data collection. Conclusions Our systematic collaboration between basic and applied behavioral scientists accelerates translation of promising basic psychological research into innovative interventions suitable for underserved, safety-net populations. At project’s end, we plan to have a feasible and acceptable self-persuasion intervention that can affect key cancer disparities in the United States through prevention of HPV-related cancers. Trial Registration ClinicalTrials.gov http://clinicaltrials.gov/ct2/show/NCT02537756 and http://clinicaltrials.gov/ct2/show/NCT02535845 (Archived by WebCite at http://www.webcitation.org/6e5XcOGXz and http://www.webcitation.org/6e5XfHoic, respectively). PMID:26825137

Overcoming the bottleneck of platelet lysate supply in large-scale clinical expansion of adipose-derived stem cells: A comparison of fresh versus three types of platelet lysates from outdated buffy coat-derived platelet concentrates.

PubMed

Glovinski, Peter V; Herly, Mikkel; Mathiasen, Anders B; Svalgaard, Jesper D; Borup, Rehannah; Talman, Maj-Lis M; Elberg, Jens J; Kølle, Stig-Frederik T; Drzewiecki, Krzysztof T; Fischer-Nielsen, Anne

2017-02-01

Platelet lysates (PL) represent a promising replacement for xenogenic growth supplement for adipose-derived stem cell (ASC) expansions. However, fresh platelets from human blood donors are not clinically feasible for large-scale cell expansion based on their limited supply. Therefore, we tested PLs prepared via three methods from outdated buffy coat-derived platelet concentrates (PCs) to establish an efficient and feasible expansion of ASCs for clinical use. PLs were prepared by the freeze-thaw method from freshly drawn platelets or from outdated buffy coat-derived PCs stored in the platelet additive solution, InterSol. Three types of PLs were prepared from outdated PCs with platelets suspended in either (1) InterSol (not manipulated), (2) InterSol + supplemented with plasma or (3) plasma alone (InterSol removed). Using these PLs, we compared ASC population doubling time, cell yield, differentiation potential and cell surface markers. Gene expression profiles were analyzed using microarray assays, and growth factor concentrations in the cell culture medium were measured using enzyme-linked immunosorbent assay (ELISA). Of the three PL compositions produced from outdated PCs, removal of Intersol and resuspension in plasma prior to the first freezing process was overall the best. This specific outdated PL induced ASC growth kinetics, surface markers, plastic adherence and differentiation potentials comparable with PL from fresh platelets. ASCs expanded in PL from fresh versus outdated PCs exhibited different expressions of 17 overlapping genes, of which 10 were involved in cellular proliferation, although not significantly reflected by cell growth. Only minor differences in growth factor turnover were observed. PLs from outdated platelets may be an efficient and reliable source of human growth supplement allowing for large-scale ASC expansion for clinical use. Copyright © 2017 International Society for Cellular Therapy. Published by Elsevier Inc. All rights reserved.

Application of A Mobile Platform-based System for the Management of Fundus Diease in Outpatient Settings.

PubMed

Dend, Xun; Li, Hong-Yan; Yin, Hong; Liang, Jian-Hong; Chen, Yi; Li, Xiao-Xin; Zhao, Ming-Wei

2016-08-01

Objective To evaluate the application of a mobile platform-based system in the management of fundus disease in outpatient settings. Methods In the outpatient departments of fundus disease,premature babies requiring eye examination under general anesthesia and adults requiring intraocular surgery were enrolled as the subjects. According to the existing clinical practices,we developed a system that met the requirements of clinical practices and optimized the clinical management. Based on the FileMaker database,the tablet computers were used as the mobile platform and the system could also be run in iPad and PC terminals.Results Since 2013,the system recorded 7500 cases of special examinations. Since July 2015,4100 cases of intravitreal drug injection were also recored in the system. Multiple-point and real-time reservation pattern increased the efficiency and opimize the clinical management. All the clinical data were digitalized. Conclusion The mobile platform-based system can increase the efficacy of examination and other clinical processes and standardize data collection;thus,it is feasible for the clinical practices in outpatient departments of ophthalmology.

Safety and Feasibility of Topical Application of Limonene as a Massage Oil to the Breast.

PubMed

Miller, Jessica A; Thompson, Patricia A; Hakim, Iman A; Lopez, Ana Maria; Thomson, Cynthia A; Chew, Wade; Hsu, Chiu-Hsieh; Chow, H-H Sherry

2012-10-01

Limonene, a major component in citrus oil, has demonstrated anti-cancer effects in preclinical mammary cancer models. However, the effective oral dose translates to a human dose that may not be feasible for chronic dosing. We proposed to evaluate topical application of limonene to the breast as an alternative dosing strategy. We conducted a mouse disposition study to determine whether limonene would be bio available in the mammary tissue after topical application. SKH-1 mice received topical or oral administration of limonene in the form of orange oil every day for 4 weeks. Plasma and mammary pads were collected 4 hrs after the final dosing. We also conducted an exploratory clinical study to evaluate the safety and feasibility of topically applied limonene in the form of orange oil to the breast. Healthy women were recruited to apply orange oil containing massage oil to their breasts daily for four weeks. Safety and feasibility were assessed by reported adverse events, clinical labs, and usage compliance. Pre and post-intervention nipple aspirate fluid (NAF) and plasma were collected for limonene concentration determination. The mouse disposition study showed that topical and oral orange oil administration resulted in similar mammary tissue disposition of limonene with no clinical signs of toxicity. In the clinical study, the topical application of limonene containing massage oil to the breast was found to be safe with high levels of usage compliance for daily application, although NAF and plasma limonene concentrations were not significantly changed after the massage oil application. Our studies showed that limonene is bio available in mammary tissue after topical orange oil application in mice and this novel route of administration to the breast is safe and feasible in healthy women.

Feasibility assessment of the interactive use of a Monte Carlo algorithm in treatment planning for intraoperative electron radiation therapy

NASA Astrophysics Data System (ADS)

Guerra, Pedro; Udías, José M.; Herranz, Elena; Santos-Miranda, Juan Antonio; Herraiz, Joaquín L.; Valdivieso, Manlio F.; Rodríguez, Raúl; Calama, Juan A.; Pascau, Javier; Calvo, Felipe A.; Illana, Carlos; Ledesma-Carbayo, María J.; Santos, Andrés

2014-12-01

This work analysed the feasibility of using a fast, customized Monte Carlo (MC) method to perform accurate computation of dose distributions during pre- and intraplanning of intraoperative electron radiation therapy (IOERT) procedures. The MC method that was implemented, which has been integrated into a specific innovative simulation and planning tool, is able to simulate the fate of thousands of particles per second, and it was the aim of this work to determine the level of interactivity that could be achieved. The planning workflow enabled calibration of the imaging and treatment equipment, as well as manipulation of the surgical frame and insertion of the protection shields around the organs at risk and other beam modifiers. In this way, the multidisciplinary team involved in IOERT has all the tools necessary to perform complex MC dosage simulations adapted to their equipment in an efficient and transparent way. To assess the accuracy and reliability of this MC technique, dose distributions for a monoenergetic source were compared with those obtained using a general-purpose software package used widely in medical physics applications. Once accuracy of the underlying simulator was confirmed, a clinical accelerator was modelled and experimental measurements in water were conducted. A comparison was made with the output from the simulator to identify the conditions under which accurate dose estimations could be obtained in less than 3 min, which is the threshold imposed to allow for interactive use of the tool in treatment planning. Finally, a clinically relevant scenario, namely early-stage breast cancer treatment, was simulated with pre- and intraoperative volumes to verify that it was feasible to use the MC tool intraoperatively and to adjust dose delivery based on the simulation output, without compromising accuracy. The workflow provided a satisfactory model of the treatment head and the imaging system, enabling proper configuration of the treatment planning system and providing good accuracy in the dosage simulation.

Accuracy and feasibility of three different methods for software-based image fusion in whole-body PET and CT.

PubMed

Putzer, Daniel; Henninger, Benjamin; Kovacs, Peter; Uprimny, Christian; Kendler, Dorota; Jaschke, Werner; Bale, Reto J

2016-06-01

Even as PET/CT provides valuable diagnostic information in a great number of clinical indications, availability of hybrid PET/CT scanners is mainly limited to clinical centers. A software-based image fusion would facilitate combined image reading of CT and PET data sets if hardware image fusion is not available. To analyze the relevance of retrospective image fusion of separately acquired PET and CT data sets, we studied the accuracy, practicability and reproducibility of three different image registration techniques. We evaluated whole-body 18F-FDG-PET and CT data sets of 71 oncologic patients. Images were fused retrospectively using Stealth Station System, Treon (Medtronic Inc., Louisville, CO, USA) equipped with Cranial4 Software. External markers fixed to a vacuum mattress were used as reference for exact repositioning. Registration was repeated using internal anatomic landmarks and Automerge software, assessing accuracy for all three methods, measuring distances of liver representation in CT and PET with reference to a common coordinate system. On first measurement of image fusions with external markers, 53 were successful, 16 feasible and 2 not successful. Using anatomic landmarks, 42 were successful, 26 feasible and 3 not successful. Using Automerge Software only 13 were successful. The mean distance between center points in PET and CT was 7.69±4.96 mm on first, and 7.65±4.2 mm on second measurement. Results with external markers correlate very well and inaccuracies are significantly lower (P<0.001) than results using anatomical landmarks (10.38±6.13 mm and 10.83±6.23 mm). Analysis revealed a significantly faster alignment using external markers (P<0.001). External fiducials in combination with immobilization devices and breathing protocols allow for highly accurate image fusion cost-effectively and significantly less time, posing an attractive alternative for PET/CT interpretation when a hybrid scanner is not available.

Echocardiographic strain and strain-rate imaging: a new tool to study regional myocardial function.

PubMed

D'hooge, Jan; Bijnens, Bart; Thoen, Jan; Van de Werf, Frans; Sutherland, George R; Suetens, Paul

2002-09-01

Ultrasonic imaging is the noninvasive clinical imaging modality of choice for diagnosing heart disease. At present, two-dimensional ultrasonic grayscale images provide a relatively cheap, fast, bedside method to study the morphology of the heart. Several methods have been proposed to assess myocardial function. These have been based on either grayscale or motion (velocity) information measured in real-time. However, the quantitative assessment of regional myocardial function remains an important goal in clinical cardiology. To do this, ultrasonic strain and strain-rate imaging have been introduced. In the clinical setting, these techniques currently only allow one component of the true three-dimensional deformation to be measured. Clinical, multidimensional strain (rate) information can currently thus only be obtained by combining data acquired using different transducer positions. Nevertheless, given the appropriate postprocessing, the clinical value of these techniques has already been shown. Moreover, multidimensional strain and strain-rate estimation of the heart in vivo by means of a single ultrasound acquisition has been shown to be feasible. In this paper, the new techniques of ultrasonic strain rate and strain imaging of the heart are reviewed in terms of definitions, data acquisition, strain-rate estimation, postprocessing, and parameter extraction. Their clinical validation and relevance will be discussed using clinical examples on relevant cardiac pathology. Based on these examples, suggestions are made for future developments of these techniques.

TIGA-CUB - manualised psychoanalytic child psychotherapy versus treatment as usual for children aged 5-11 years with treatment-resistant conduct disorders and their primary carers: study protocol for a randomised controlled feasibility trial.

PubMed

Edginton, Elizabeth; Walwyn, Rebecca; Burton, Kayleigh; Cicero, Robert; Graham, Liz; Reed, Sadie; Tubeuf, Sandy; Twiddy, Maureen; Wright-Hughes, Alex; Ellis, Lynda; Evans, Dot; Hughes, Tom; Midgley, Nick; Wallis, Paul; Cottrell, David

2017-09-15

The National Institute for Health and Care Excellence (NICE) recommends evidence-based parenting programmes as a first-line intervention for conduct disorders (CD) in children aged 5-11 years. As these are not effective in 25-33% of cases, NICE has requested research into second-line interventions. Child and Adolescent Psychotherapists (CAPTs) address highly complex problems where first-line treatments have failed and there have been small-scale studies of Psychoanalytic Child Psychotherapy (PCP) for CD. A feasibility trial is needed to determine whether a confirmatory trial of manualised PCP (mPCP) versus Treatment as Usual (TaU) for CD is practicable or needs refinement. The aim of this paper is to publish the abridged protocol of this feasibility trial. TIGA-CUB (Trial on improving Inter-Generational Attachment for Children Undergoing Behaviour problems) is a two-arm, pragmatic, parallel-group, multicentre, individually randomised (1:1) controlled feasibility trial (target n = 60) with blinded outcome assessment (at 4 and 8 months), which aims to develop an optimum practicable protocol for a confirmatory, pragmatic, randomised controlled trial (RCT) (primary outcome: child's behaviour; secondary outcomes: parental reflective functioning and mental health, child and parent quality of life), comparing mPCP and TaU as second-line treatments for children aged 5-11 years with treatment-resistant CD and inter-generational attachment difficulties, and for their primary carers. Child-primary carer dyads will be recruited following a referral to, or re-referral within, National Health Service (NHS) Child and Adolescent Mental Health Services (CAMHS) after an unsuccessful first-line parenting intervention. PCP will be delivered by qualified CAPTs working in routine NHS clinical practice, using a trial-specific PCP manual (a brief version of established PCP clinical practice). Outcomes are: (1) feasibility of recruitment methods, (2) uptake and follow-up rates, (3) therapeutic delivery, treatment retention and attendance, intervention adherence rates, (4) follow-up data collection, and (5) statistical, health economics, process evaluation, and qualitative outcomes. TIGA-CUB will provide important information on the feasibility and potential challenges of undertaking a confirmatory RCT to evaluate the effectiveness and cost-effectiveness of mPCP. Current Controlled Trials, ID: ISRCTN86725795 . Registered on 31 May 2016.

Automation and intensity modulated radiation therapy for individualized high-quality tangent breast treatment plans.

PubMed

Purdie, Thomas G; Dinniwell, Robert E; Fyles, Anthony; Sharpe, Michael B

2014-11-01

To demonstrate the large-scale clinical implementation and performance of an automated treatment planning methodology for tangential breast intensity modulated radiation therapy (IMRT). Automated planning was used to prospectively plan tangential breast IMRT treatment for 1661 patients between June 2009 and November 2012. The automated planning method emulates the manual steps performed by the user during treatment planning, including anatomical segmentation, beam placement, optimization, dose calculation, and plan documentation. The user specifies clinical requirements of the plan to be generated through a user interface embedded in the planning system. The automated method uses heuristic algorithms to define and simplify the technical aspects of the treatment planning process. Automated planning was used in 1661 of 1708 patients receiving tangential breast IMRT during the time interval studied. Therefore, automated planning was applicable in greater than 97% of cases. The time for treatment planning using the automated process is routinely 5 to 6 minutes on standard commercially available planning hardware. We have shown a consistent reduction in plan rejections from plan reviews through the standard quality control process or weekly quality review multidisciplinary breast rounds as we have automated the planning process for tangential breast IMRT. Clinical plan acceptance increased from 97.3% using our previous semiautomated inverse method to 98.9% using the fully automated method. Automation has become the routine standard method for treatment planning of tangential breast IMRT at our institution and is clinically feasible on a large scale. The method has wide clinical applicability and can add tremendous efficiency, standardization, and quality to the current treatment planning process. The use of automated methods can allow centers to more rapidly adopt IMRT and enhance access to the documented improvements in care for breast cancer patients, using technologies that are widely available and already in clinical use. Copyright © 2014 Elsevier Inc. All rights reserved.

Frequent sampling allows detection of short and rapid surges of exhaled ethane during cardiac surgery.

PubMed

Stenseth, R; Nilsen, T; Haaverstad, R; Vitale, N; Dale, O

2007-11-01

During cardiopulmonary bypass (CPB), hypoperfusion and reperfusion may cause oxidative stress and lipid peroxidation that generates ethane. The aim of this pilot study was to assess the feasibility of frequent sampling of exhaled ethane during cardiac surgery. After approval of the Research Ethics Committee, 10 patients undergoing combined aortic valve and coronary artery bypass surgery were enrolled. Breath samples were drawn in the perioperative period and analyzed by a rapid, sensitive and validated gas-chromatographic method. Increased exhaled ethane was regularly seen following sternotomy, after the start of CPB and after aortic clamp removal, whereas no change was seen after termination of bypass. In one patient, the maximum increase in exhaled ethane was 30-fold. Peak durations lasted only 2-4 min. This study demonstrates that frequent sampling of breath ethane is feasible in a clinical setting, allowing detection of rapid ethane surges of short duration.

Impact of Expiratory Strength Training in Amyotrophic Lateral Sclerosis

PubMed Central

Plowman, Emily K.; Watts, Stephanie A.; Tabor, Lauren; Robison, Raele; Gaziano, Joy; Domer, Amanda S.; Richter, Joel; Vu, Tuan; Gooch, Clifton

2016-01-01

Introduction We evaluated the feasibility and impact of Expiratory Muscle Strength Training (EMST) on respiratory and bulbar function in persons with amyotrophic lateral sclerosis (ALS). Methods 25 ALS patients participated in this delayed intervention open-label clinical trial. Following a lead-in period, patients completed a 5-week EMST protocol. Outcome measures included: maximum expiratory pressure (MEP), physiologic measures of swallow and cough, and Penetration-Aspiration Scale (PAS) scores. Results Of those participants who entered the active phase of the study (n=15), EMST was well tolerated and led to significant increases in MEPs and maximum hyoid displacement during swallowing post-EMST (P<0.05). No significant differences were observed for PAS scores or cough spirometry measures. Discussion EMST was feasible and well tolerated in this small cohort of ALS patients and led to improvements in expiratory force-generating pressures and swallow kinematics. Further investigation is warranted to confirm these preliminary findings. PMID:26599236

Feasibility study for future implantable neural-silicon interface devices.

PubMed

Al-Armaghany, Allann; Yu, Bo; Mak, Terrence; Tong, Kin-Fai; Sun, Yihe

2011-01-01

The emerging neural-silicon interface devices bridge nerve systems with artificial systems and play a key role in neuro-prostheses and neuro-rehabilitation applications. Integrating neural signal collection, processing and transmission on a single device will make clinical applications more practical and feasible. This paper focuses on the wireless antenna part and real-time neural signal analysis part of implantable brain-machine interface (BMI) devices. We propose to use millimeter-wave for wireless connections between different areas of a brain. Various antenna, including microstrip patch, monopole antenna and substrate integrated waveguide antenna are considered for the intra-cortical proximity communication. A Hebbian eigenfilter based method is proposed for multi-channel neuronal spike sorting. Folding and parallel design techniques are employed to explore various structures and make a trade-off between area and power consumption. Field programmable logic arrays (FPGAs) are used to evaluate various structures.

Use of a single bipolar electrode in the posterior arytenoid muscles for bilateral monitoring of the recurrent laryngeal nerves in thyroid surgery.

PubMed

Haerle, Stephan; Sidler, D; Linder, Th; Mueller, W

2008-12-01

The aims were to assess the technical feasibility of using a single electrode in the posterior arytenoid muscles (PAM) for intraoperative monitoring of the recurrent laryngeal nerve (RLN) in thyroid surgery, to validate the new method against the insertion of electrodes placed in the vocal cord muscle, and to report the results of the clinical application of the new concept. A total of 52 patients were enrolled. The handling and safety of RLN monitoring was tested by simultaneous registration of the EMG response from vocal fold electrodes and PAM electrodes. Acoustically and electromyographically we found nearly the same values for the arytenoid muscles as for the vocal folds, although the signals taken from the vocal folds were slightly stronger. PAM recording using a single bipolar electrode is technically feasible and as reliable compared to the standard vocal cord monitoring.

The role of vaccines in the control of STDs: HPV vaccines.

PubMed Central

Frazer, I H

1996-01-01

Prophylactic vaccines for genital human papillomavirus (HPV) infection have been shown to be feasible in animal models, and suitable vaccine material based on virus-like particles can be produced in bulk at reasonable cost. Initiation of phase III clinical trials will follow definition of trial outcome measures through further epidemiological studies, and development of assays of host protective immunity. Vaccines could in principle eliminate HPV-related disease, as the human race is the only natural host for the relevant papillomaviruses (PVs). Therapeutic vaccines for genital HPV infection are also possible, but have not yet been demonstrated as feasible in practice because the choice of vaccine antigens is difficult, the method of their optimal delivery is uncertain, and the nature of the relevant antiviral immunity is unknown. PV species specificity will require trials to be conducted in man, which will slow definition of an ideal vaccine. PMID:9038634

A set of care quality indicators for stroke management.

PubMed

Navarro Soler, I M; Ignacio García, E; Masjuan Vallejo, J; Gállego Culleré, J; Mira Solves, J J

2017-06-22

This study proposes a set of quality indicators for care outcomes in patients with acute cerebral infarction. These indicators are understandable and relevant from a clinical viewpoint, as well as being acceptable and feasible in terms of time required, ease of data capture, and interpretability. The method consisted of reaching consensus among doctors after having reviewed the literature on quality indicators in stroke. We then designed and conducted a field study to assess the understandability and feasibility of the set of indicators. Consensus yielded 8 structural indicators, 5 process indicators, and 12 result indicators. Additionally, standards of reference were established for each indicator. This set of indicators can be used to monitor the quality care for stroke patients, identify strengths, and potentially to identify areas needing improvement. Copyright © 2017 Sociedad Española de Neurología. Publicado por Elsevier España, S.L.U. All rights reserved.

Smartphone App Using Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS): Protocol for a Randomized Feasibility Trial

PubMed Central

Newton, Sian; Kahan, Brennan C; Forbes, Gordon; Wright, Neil; Cantalapiedra Calvete, Clara; Gibson, Harry A L; Rogozinska, Ewelina; Rivas, Carol; Taylor, Stephanie J C; Birch, Judy; Dodds, Julie

2018-01-01

Background Female chronic pelvic pain (CPP) is defined as intermittent or constant pelvic or lower abdominal pain occurring in a woman for at least 6 months. Up to a quarter of women are estimated to be affected by CPP worldwide and it is responsible for one fifth of specialist gynecological referrals in the United Kingdom. Psychological interventions are commonly utilized. As waiting times and funding capacity impede access to face-to-face consultations, supported self-management (SSM) has emerged as a viable alternative. Mindfulness meditation is a potentially valuable SSM tool, and in the era of mobile technology, this can be delivered to the individual user via a smartphone app. Objective To assess the feasibility of conducting a trial of a mindfulness meditation intervention delivered by a mobile phone app for patients with CPP. The main feasibility objectives were to assess patient recruitment and app adherence, to obtain information to be used in the sample size estimate of a future trial, and to receive feedback on usability of the app. Methods Mindfulness Meditation for Women With Chronic Pelvic Pain (MEMPHIS) is a three-arm feasibility trial, that took place in two hospitals in the United Kingdom. Eligible participants were randomized in a 1:1:1 ratio to one of three treatment arms: (1) the intervention arm, consisting of a guided, spoken mindfulness meditation app; (2) an active control arm, consisting of a progressive muscle relaxation app; and (3) usual care (no app). Participants were followed-up for 6 months. Key feasibility outcomes included the time taken to recruit all patients for the study, adherence, and estimates to be used in the sample size calculation for a subsequent full-scale trial. Upon completion of the feasibility trial we will conduct focus groups to explore app usability and reasons for noncompliance. Results Recruitment for MEMPHIS took place between May 2016 and September 2016. The study was closed March 2017 and the report was submitted to the NIHR on October 26, 2017. Conclusions This feasibility trial will inform the design of a large multicentered trial to assess the clinical effectiveness of mindfulness meditation delivered via a smartphone app for the treatment of CPP. Trial Registration ClinicalTrials.gov: NCT02721108; https://clinicaltrials.gov/ct2/show/NCT02721108 (Archived by WebCite at http://www.webcitation.org/6wLMAkuaU); BioMed Central: ISRCTN10925965; https://www.isrctn.com/ISRCTN10925965 (Archived by WebCite at http://www.webcitation.org/6wLMVLuys) PMID:29335232

Protocol for a multicentre randomised feasibility STUdy evaluating the impact of a prognostic model for Management of BLunt chest wall trauma patients: STUMBL trial.

PubMed

Battle, Ceri; Abbott, Zoe; Hutchings, Hayley A; O'Neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona E; Jones, Sally; Gagg, James; Body, Richard; Evans, Philip A

2017-07-10

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the emergency department (ED). A definitive randomised controlled trial (impact trial) is required to assess the clinical and cost effectiveness of the new model before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multicentre, cluster-randomised (stepped- wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a 5-month period; in the initial period acting as the controls (normal care), and in the second period acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a 6-week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory). Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Patient recruitment will commence in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal , presentation at appropriate conferences and to stakeholders at professional meetings. ISRCTN95571506; Pre-results. © 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.

12 A multi-centre randomised feasibility study evaluating the impact of a prognostic model for management of blunt chest wall trauma patients: stumbl trial.

PubMed

Battle, Ceri; Hutchings, Hayley; Abbott, Zoe; O'neill, Claire; Groves, Sam; Watkins, Alan; Lecky, Fiona; Jones, Sally; Gagg, James; Body, Rick; Evans, Phillip

2017-12-01

A new prognostic model has been developed and externally validated, the aim of which is to assist in the management of the blunt chest wall trauma patient in the Emergency Department (ED). A definitive randomised controlled trial (impact trial), is required to assess the clinical and cost effectiveness of the new model, before it can be accepted in clinical practice. The purpose of this trial is to assess the feasibility and acceptability of such a definitive trial and inform its design. This feasibility trial is designed to test the methods of a multi-centre, cluster-randomised (stepped wedge) trial, with a substantial qualitative component. Four EDs in England and Wales will collect data for all blunt chest wall trauma patients over a five month period; in the initial period acting as the controls (normal care) and the second period, acting as the interventions (in which the new model will be used). Baseline measurements including completion of the SF-12v2 will be obtained on initial assessment in the ED. Patient outcome data will then be collected for any subsequent hospitalisations. Data collection will conclude with a six week follow-up completion of two surveys (SF-12v2 and Client Services Receipt Inventory).Analysis of outcomes will focus on feasibility, acceptability and trial processes and will include recruitment and retention rates, attendance at clinician training rates and use of model in the ED. Qualitative feedback will be obtained through clinician interviews and a research nurse focus group. An evaluation of the feasibility of health economics outcomes data will be completed. Wales Research Ethics Committee 6 granted approval for the trial in September 2016. Health Care Research Wales Research Permissions and the HRA have granted approval for the study. Patient recruitment commenced in February 2017. Planned dissemination is through publication in a peer-reviewed Emergency Medicine Journal, presentation at appropriate conferences and to stakeholders at Professional Meetings. © 2017, 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.