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.

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.

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…

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'.

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

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.

JCCRER Project 2.3 -- Deterministic effects of occupational exposure to radiation. Phase 1: Feasibility study; Final report

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

Okladnikova, N.; Pesternikova, V.; Sumina, M.

1998-12-01

Phase 1 of Project 2.3, a short-term collaborative Feasibility Study, was funded for 12 months starting on 1 February 1996. The overall aim of the study was to determine the practical feasibility of using the dosimetric and clinical data on the MAYAK worker population to study the deterministic effects of exposure to external gamma radiation and to internal alpha radiation from inhaled plutonium. Phase 1 efforts were limited to the period of greatest worker exposure (1948--1954) and focused on collaboratively: assessing the comprehensiveness, availability, quality, and suitability of the Russian clinical and dosimetric data for the study of deterministic effects;more » creating an electronic data base containing complete clinical and dosimetric data on a small, representative sample of MAYAK workers; developing computer software for the testing of a currently used health risk model of hematopoietic effects; and familiarizing the US team with the Russian diagnostic criteria and techniques used in the identification of Chronic Radiation Sickness.« less

'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

CONTRACT Study - CONservative TReatment of Appendicitis in Children (feasibility): study protocol for a randomised controlled Trial.

PubMed

Hutchings, Natalie; Wood, Wendy; Reading, Isabel; Walker, Erin; Blazeby, Jane M; Van't Hoff, William; Young, Bridget; Crawley, Esther M; Eaton, Simon; Chorozoglou, Maria; Sherratt, Frances C; Beasant, Lucy; Corbett, Harriet; Stanton, Michael P; Grist, Simon; Dixon, Elizabeth; Hall, Nigel J

2018-03-02

Currently, the routine treatment for acute appendicitis in the United Kingdom is an appendicectomy. However, there is increasing scientific interest and research into non-operative treatment of appendicitis in adults and children. While a number of studies have investigated non-operative treatment of appendicitis in adults, this research cannot be applied to the paediatric population. Ultimately, we aim to perform a UK-based multicentre randomised controlled trial (RCT) to test the clinical and cost effectiveness of non-operative treatment of acute uncomplicated appendicitis in children, as compared with appendicectomy. First, we will undertake a feasibility study to assess the feasibility of performing such a trial. The study involves a feasibility RCT with a nested qualitative research to optimise recruitment as well as a health economic substudy. Children (aged 4-15 years inclusive) diagnosed with acute uncomplicated appendicitis that would normally be treated with an appendicectomy are eligible for the RCT. Exclusion criteria include clinical/radiological suspicion of perforated appendicitis, appendix mass or previous non-operative treatment of appendicitis. Participants will be randomised into one of two arms. Participants in the intervention arm are treated with antibiotics and regular clinical assessment to ensure clinical improvement. Participants in the control arm will receive appendicectomy. Randomisation will be minimised by age, sex, duration of symptoms and centre. Children and families who are approached for the RCT will be invited to participate in the embedded qualitative substudy, which includes recording of recruitment consultants and subsequent interviews with participants and non-participants and their families and recruiters. Analyses of these will inform interventions to optimise recruitment. The main study outcomes include recruitment rate (primary outcome), identification of strategies to optimise recruitment, performance of trial treatment pathways, clinical outcomes and safety of non-operative treatment. We have involved children, young people and parents in study design and delivery. In this study we will explore the feasibility of performing a full efficacy RCT comparing non-operative treatment with appendicectomy in children with acute uncomplicated appendicitis. Factors determining success of the present study include recruitment rate, safety of non-operative treatment and adequate interest in the future RCT. Ultimately this feasibility study will form the foundation of the main RCT and reinforce its design. ISRCTN15830435 . Registered on 8 February 2017.

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.

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

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.

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

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

PubMed

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

2017-08-01

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. 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. 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. © 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.

Assessing the feasibility of the Effectiveness of Discontinuing Bisphosphonates trial: a pilot study.

PubMed

Wright, N C; Foster, P J; Mudano, A S; Melnick, J A; Lewiecki, M E; Shergy, W J; Curtis, J R; Cutter, G R; Danila, M I; Kilgore, M L; Lewis, E C; Morgan, S L; Redden, D T; Warriner, A H; Saag, K G

2017-08-01

The Effectiveness of Discontinuing Bisphosphonates (EDGE) study is a planned pragmatic clinical trial to guide "drug holiday" clinical decision making. This pilot study assessed work flow and feasibility of such a study. While participant recruitment and treatment adherence were suboptimal, administrative procedures were generally feasible and minimally disrupted clinic flow. The comparative effectiveness of continuing or discontinuing long-term alendronate (ALN) on fractures is unknown. A large pragmatic ALN discontinuation study has potential to answer this question. We conducted a 6-month pilot study of the planned the EDGE study among current long-term ALN users (women aged ≥65 with ≥3 years of ALN use) to determine study work flow and feasibility including evaluating the administrative aspects of trial conduct (e.g., time to contract, institutional review board (IRB) approval), assessing rates of site and participant recruitment, and evaluating post-randomization outcomes, including adherence, bisphosphonate-associated adverse events, and participant and site satisfaction. We assessed outcomes 1 and 6 months after randomization. Nine sites participated, including seven community-based medical practices and two academic medical centers. On average (SD), contract execution took 3.4 (2.3) months and IRB approval took 13.9 (4.1) days. Sites recruited 27 participants (13 to continue ALN and 14 to discontinue ALN). Over follow-up, 22% of participants did not adhere to their randomization assignment: 30.8% in the continuation arm and 14.3% in the discontinuation arm. No fractures or adverse events were reported. Sites reported no issues regarding work flow, and participants were highly satisfied with the study. Administrative procedures of the EDGE study were generally feasible, with minimal disruption to clinic flow. In this convenience sample, participant recruitment was suboptimal across most practice sites. Accounting for low treatment arm adherence, a comprehensive recruitment approach will be needed to effectively achieve the scientific goals of the EDGE study.

Feasibility study of utilizing ultraportable projectors for endoscopic video display (with videos).

PubMed

Tang, Shou-Jiang; Fehring, Amanda; Mclemore, Mac; Griswold, Michael; Wang, Wanmei; Paine, Elizabeth R; Wu, Ruonan; To, Filip

2014-10-01

Modern endoscopy requires video display. Recent miniaturized, ultraportable projectors are affordable, durable, and offer quality image display. Explore feasibility of using ultraportable projectors in endoscopy. Prospective bench-top comparison; clinical feasibility study. Masked comparison study of images displayed via 2 Samsung ultraportable light-emitting diode projectors (pocket-sized SP-HO3; pico projector SP-P410M) and 1 Microvision Showwx-II Laser pico projector. BENCH-TOP FEASIBILITY STUDY: Prerecorded endoscopic video was streamed via computer. CLINICAL COMPARISON STUDY: Live high-definition endoscopy video was simultaneously displayed through each processor onto a standard liquid crystal display monitor and projected onto a portable, pull-down projection screen. Endoscopists, endoscopy nurses, and technicians rated video images; ratings were analyzed by linear mixed-effects regression models with random intercepts. All projectors were easy to set up, adjust, focus, and operate, with no real-time lapse for any. Bench-top study outcomes: Samsung pico preferred to Laser pico, overall rating 1.5 units higher (95% confidence interval [CI] = 0.7-2.4), P < .001; Samsung pocket preferred to Laser pico, 3.3 units higher (95% CI = 2.4-4.1), P < .001; Samsung pocket preferred to Samsung pico, 1.7 units higher (95% CI = 0.9-2.5), P < .001. The clinical comparison study confirmed the Samsung pocket projector as best, with a higher overall rating of 2.3 units (95% CI = 1.6-3.0), P < .001, than Samsung pico. Low brightness currently limits pico projector use in clinical endoscopy. The pocket projector, with higher brightness levels (170 lumens), is clinically useful. Continued improvements to ultraportable projectors will supply a needed niche in endoscopy through portability, reduced cost, and equal or better image quality. © The Author(s) 2013.

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.

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.

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.

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.

Feasibility of energy medicine in a community teaching hospital: an exploratory case series.

PubMed

Dufresne, Francois; Simmons, Bonnie; Vlachostergios, Panagiotis J; Fleischner, Zachary; Joudeh, Ramsey; Blakeway, Jill; Julliard, Kell

2015-06-01

Energy medicine (EM) derives from the theory that a subtle biologic energy can be influenced for therapeutic effect. EM practitioners may be trained within a specific tradition or work solo. Few studies have investigated the feasibility of solo-practitioner EM in hospitals. This study investigated the feasibility of EM as provided by a solo practitioner in inpatient and emergent settings. Feasibility study, including a prospective case series. Inpatient units and emergency department. To investigate the feasibility of EM, acceptability, demand, implementation, and practicality were assessed. Short-term clinical changes were documented by treating physicians. Patients, employees, and family members were enrolled in the study only if study physicians expected no or slow improvement in specific symptoms. Those with secondary gains or who could not communicate perception of symptom change were excluded. EM was found to have acceptability and demand, and implementation was smooth because study procedures dovetailed with conventional clinical practice. Practicality was acceptable within the study but was low upon further application of EM because of cost of program administration. Twenty-four of 32 patients requested relief from pain. Of 50 reports of pain, 5 (10%) showed no improvement; 4 (8%), slight improvement; 3 (6%), moderate improvement; and 38 (76%), marked improvement. Twenty-one patients had issues other than pain. Of 29 non-pain-related problems, 3 (10%) showed no, 2 (7%) showed slight, 1 (4%) showed moderate, and 23 (79%) showed marked improvement. Changes during EM sessions were usually immediate. This study successfully implemented EM provided by a solo practitioner in inpatient and emergent hospital settings and found that acceptability and demand justified its presence. Most patients experienced marked, immediate improvement of symptoms associated with their chief complaint. Substantial practicality issues must be addressed to implement EM clinically in a hospital, however.

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.

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

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.

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

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

Development and Feasibility Testing of a Critical Care EEG Monitoring Database for Standardized Clinical Reporting and Multicenter Collaborative Research.

PubMed

Lee, Jong Woo; LaRoche, Suzette; Choi, Hyunmi; Rodriguez Ruiz, Andres A; Fertig, Evan; Politsky, Jeffrey M; Herman, Susan T; Loddenkemper, Tobias; Sansevere, Arnold J; Korb, Pearce J; Abend, Nicholas S; Goldstein, Joshua L; Sinha, Saurabh R; Dombrowski, Keith E; Ritzl, Eva K; Westover, Michael B; Gavvala, Jay R; Gerard, Elizabeth E; Schmitt, Sarah E; Szaflarski, Jerzy P; Ding, Kan; Haas, Kevin F; Buchsbaum, Richard; Hirsch, Lawrence J; Wusthoff, Courtney J; Hopp, Jennifer L; Hahn, Cecil D

2016-04-01

The rapid expansion of the use of continuous critical care electroencephalogram (cEEG) monitoring and resulting multicenter research studies through the Critical Care EEG Monitoring Research Consortium has created the need for a collaborative data sharing mechanism and repository. The authors describe the development of a research database incorporating the American Clinical Neurophysiology Society standardized terminology for critical care EEG monitoring. The database includes flexible report generation tools that allow for daily clinical use. Key clinical and research variables were incorporated into a Microsoft Access database. To assess its utility for multicenter research data collection, the authors performed a 21-center feasibility study in which each center entered data from 12 consecutive intensive care unit monitoring patients. To assess its utility as a clinical report generating tool, three large volume centers used it to generate daily clinical critical care EEG reports. A total of 280 subjects were enrolled in the multicenter feasibility study. The duration of recording (median, 25.5 hours) varied significantly between the centers. The incidence of seizure (17.6%), periodic/rhythmic discharges (35.7%), and interictal epileptiform discharges (11.8%) was similar to previous studies. The database was used as a clinical reporting tool by 3 centers that entered a total of 3,144 unique patients covering 6,665 recording days. The Critical Care EEG Monitoring Research Consortium database has been successfully developed and implemented with a dual role as a collaborative research platform and a clinical reporting tool. It is now available for public download to be used as a clinical data repository and report generating tool.

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.

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

PubMed

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.

Development and feasibility of a web-based question prompt sheet to support information provision of health-related quality of life topics after oesophageal cancer surgery.

PubMed

Jacobs, M; Henselmans, I; Arts, D L; Ten Koppel, M; Gisbertz, S S; Lagarde, S M; van Berge Henegouwen, M I; Sprangers, M A G; de Haes, H C J M; Smets, E M A

2018-01-01

We developed a web-based question prompt sheet (QPS) to support information provision of health-related quality of life (HRQL) topics after oesophageal cancer surgery. The QPS was evaluated and updated in three consecutive studies. In Study 1, eight patients were guided in using the QPS. Feasibility was assessed by cognitive walkthrough, questionnaire and interview. We obtained 430 notes (217 negative, 213 positive) of patients' actions and or remarks, and 91 suggestions. With minor support, most patients were able to use the QPS. In Study 2, forty patients independently used and appraised a modified version of the QPS by questionnaire. All patients deemed the QPS to be usable and useful. In Study 3, 21 patients and three surgeons used the QPS in clinical practice. Clinical feasibility was assessed by the number of QPS sent to the researcher/surgeon. Patients and surgeons were surveyed and the follow-up consultation was audio-recorded. Surgeons were additionally interviewed. Twenty/fourteen patients sent their QPS to the researcher/surgeon. Five QPSs were read by the consultation surgeon. Patients considered the QPS usable and useful. Surgeons considered the QPS of added value and helpful in informing patients, but currently not clinically feasible due to increased consultation time. © 2016 John Wiley & Sons Ltd.

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

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

An integrative model for in-silico clinical-genomics discovery science.

PubMed

Lussier, Yves A; Sarkar, Indra Nell; Cantor, Michael

2002-01-01

Human Genome discovery research has set the pace for Post-Genomic Discovery Research. While post-genomic fields focused at the molecular level are intensively pursued, little effort is being deployed in the later stages of molecular medicine discovery research, such as clinical-genomics. The objective of this study is to demonstrate the relevance and significance of integrating mainstream clinical informatics decision support systems to current bioinformatics genomic discovery science. This paper is a feasibility study of an original model enabling novel "in-silico" clinical-genomic discovery science and that demonstrates its feasibility. This model is designed to mediate queries among clinical and genomic knowledge bases with relevant bioinformatic analytic tools (e.g. gene clustering). Briefly, trait-disease-gene relationships were successfully illustrated using QMR, OMIM, SNOMED-RT, GeneCluster and TreeView. The analyses were visualized as two-dimensional dendrograms of clinical observations clustered around genes. To our knowledge, this is the first study using knowledge bases of clinical decision support systems for genomic discovery. Although this study is a proof of principle, it provides a framework for the development of clinical decision-support-system driven, high-throughput clinical-genomic technologies which could potentially unveil significant high-level functions of genes.

Intramyocardial injection of autologous bone marrow-derived ex vivo expanded mesenchymal stem cells in acute myocardial infarction patients is feasible and safe up to 5 years of follow-up.

PubMed

Rodrigo, Sander F; van Ramshorst, Jan; Hoogslag, Georgette E; Boden, Helèn; Velders, Matthijs A; Cannegieter, Suzanne C; Roelofs, Helene; Al Younis, Imad; Dibbets-Schneider, Petra; Fibbe, Willem E; Zwaginga, Jaap Jan; Bax, Jeroen J; Schalij, Martin J; Beeres, Saskia L; Atsma, Douwe E

2013-10-01

In experimental studies, mesenchymal stem cell (MSC) transplantation in acute myocardial infarction (AMI) models has been associated with enhanced neovascularization and myogenesis. Clinical data however, are scarce. Therefore, the present study evaluates the safety and feasibility of intramyocardial MSC injection in nine patients, shortly after AMI during short-term and 5-year follow-up. Periprocedural safety analysis demonstrated one transient ischemic attack. No other adverse events related to MSC treatment were observed during 5-year follow-up. Clinical events were compared to a nonrandomized control group comprising 45 matched controls. A 5-year event-free survival after MSC-treatment was comparable to controls (89 vs. 91 %, P = 0.87). Echocardiographic imaging for evaluation of left ventricular function demonstrated improvements up to 5 years after MSC treatment. These findings were not significantly different when compared to controls. The present safety and feasibility study suggest that intramyocardial injection of MSC in patients shortly after AMI is feasible and safe up to 5-year follow-up.

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.

Feasibility, acceptability and clinical utility of the Cultural Formulation Interview: mixed-methods results from the DSM-5 international field trial.

PubMed

Lewis-Fernández, Roberto; Aggarwal, Neil Krishan; Lam, Peter C; Galfalvy, Hanga; Weiss, Mitchell G; Kirmayer, Laurence J; Paralikar, Vasudeo; Deshpande, Smita N; Díaz, Esperanza; Nicasio, Andel V; Boiler, Marit; Alarcón, Renato D; Rohlof, Hans; Groen, Simon; van Dijk, Rob C J; Jadhav, Sushrut; Sarmukaddam, Sanjeev; Ndetei, David; Scalco, Monica Z; Bassiri, Kavoos; Aguilar-Gaxiola, Sergio; Ton, Hendry; Westermeyer, Joseph; Vega-Dienstmaier, Johann M

2017-04-01

Background There is a need for clinical tools to identify cultural issues in diagnostic assessment. Aims To assess the feasibility, acceptability and clinical utility of the DSM-5 Cultural Formulation Interview (CFI) in routine clinical practice. Method Mixed-methods evaluation of field trial data from six countries. The CFI was administered to diagnostically diverse psychiatric out-patients during a diagnostic interview. In post-evaluation sessions, patients and clinicians completed debriefing qualitative interviews and Likert-scale questionnaires. The duration of CFI administration and the full diagnostic session were monitored. Results Mixed-methods data from 318 patients and 75 clinicians found the CFI feasible, acceptable and useful. Clinician feasibility ratings were significantly lower than patient ratings and other clinician-assessed outcomes. After administering one CFI, however, clinician feasibility ratings improved significantly and subsequent interviews required less time. Conclusions The CFI was included in DSM-5 as a feasible, acceptable and useful cultural assessment tool. © The Royal College of Psychiatrists 2017.

A Process Improvement Study on a Military System of Clinics to Manage Patient Demand and Resource Utilization Using Discrete-Event Simulation, Sensitivity Analysis, and Cost-Benefit Analysis

DTIC Science & Technology

2015-03-12

26 Table 3: Optometry Clinic Frequency Count... Optometry Clinic Frequency Count.................................................................. 86 Table 22: Probability Distribution Summary Table...Clinic, the Audiology Clinic, and the Optometry Clinic. Methodology Overview The overarching research goal is to identify feasible solutions to

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

PubMed

Giesbrecht, Edward M; Miller, William C; Eng, Janice J; Mitchell, Ian M; Woodgate, Roberta L; Goldsmith, Charles H

2013-10-24

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. 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. 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. Clinical Trials NCT01740635.

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

Federal Register 2010, 2011, 2012, 2013, 2014

2011-10-24

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and... notice under Public Law 92-463 (Federal Advisory Committee Act) that a meeting of the Clinical Science...

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-08-27

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Clinical Science Research and Development Service on the relevance and feasibility of proposed projects and...

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.

Telephone Administration of the Aberrant Behavior Checklist: A Pilot Study of Feasibility in Children with Intellectual Disability and Autism

ERIC Educational Resources Information Center

Siegel, Matthew; Milligan, Briana; Stein, Hannah; Teer, Olivia; Smith, Kahsi A.

2013-01-01

To advance clinical care and research in children with intellectual disability and autism there is a growing need for efficient means to measure behavioral severity and response to treatment. The objective of this study was to assess the feasibility of telephone administration of the Aberrant Behavior Checklist-Irritability Subscale (ABC-I). The…

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.

Biological effects of electrolyzed water in hemodialysis.

PubMed

Nakayama, Masaaki; Kabayama, Shigeru; Nakano, Hirofumi; Zhu, Wan-Jun; Terawaki, Hiroyuki; Nakayama, Keisuke; Katoh, Kiyoshi; Satoh, Toshinobu; Ito, Sadayoshi

2009-01-01

The application of electrolyzed water (EW) at the cathode side to manufacture reverse osmosis (RO) water and hemodialysis (HD) solution can actually lead to less oxidative capacity in chemical terms. The present study examined the biological actions of this water on human polymorphonuclear leukocytes (PMNs), and the clinical feasibility of applying this technology to HD treatment. RO water using EW (e-RO) exhibited less chemiluminescence in luminol-hydrogen peroxide and higher dissolved hydrogen levels (-99.0 ppb) compared with control RO water. The effects of e-RO on PMN viability were tested. HD using e-RO was performed for 12 consecutive sessions in 8 patients for the feasibility test. Basal cellular viability and function to generate superoxide radicals of PMNs were better preserved by e-RO application. In the clinical trial, reductions of blood pressure were noted, but no adverse events were observed. There were no changes in the blood dialysis parameters, although methylguanidine levels were significantly decreased at the end of study. The present study demonstrated the capacity of e-RO to preserve the viability of PMNs, and the clinical feasibility of applying this water for HD treatment. The clinical application of this technology may improve the bio-compatibility of HD treatment. Copyright 2009 S. Karger AG, Basel.

A tutorial on pilot studies: the what, why and how

PubMed Central

2010-01-01

Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

Feasibility of Energy Medicine in a Community Teaching Hospital: An Exploratory Case Series

PubMed Central

Dufresne, Francois; Simmons, Bonnie; Vlachostergios, Panagiotis J.; Fleischner, Zachary; Joudeh, Ramsey; Blakeway, Jill

2015-01-01

Abstract Background: Energy medicine (EM) derives from the theory that a subtle biologic energy can be influenced for therapeutic effect. EM practitioners may be trained within a specific tradition or work solo. Few studies have investigated the feasibility of solo-practitioner EM in hospitals. Objective: This study investigated the feasibility of EM as provided by a solo practitioner in inpatient and emergent settings. Design: Feasibility study, including a prospective case series. Settings: Inpatient units and emergency department. Outcome measures: To investigate the feasibility of EM, acceptability, demand, implementation, and practicality were assessed. Short-term clinical changes were documented by treating physicians. Participants: Patients, employees, and family members were enrolled in the study only if study physicians expected no or slow improvement in specific symptoms. Those with secondary gains or who could not communicate perception of symptom change were excluded. Results: EM was found to have acceptability and demand, and implementation was smooth because study procedures dovetailed with conventional clinical practice. Practicality was acceptable within the study but was low upon further application of EM because of cost of program administration. Twenty-four of 32 patients requested relief from pain. Of 50 reports of pain, 5 (10%) showed no improvement; 4 (8%), slight improvement; 3 (6%), moderate improvement; and 38 (76%), marked improvement. Twenty-one patients had issues other than pain. Of 29 non–pain-related problems, 3 (10%) showed no, 2 (7%) showed slight, 1 (4%) showed moderate, and 23 (79%) showed marked improvement. Changes during EM sessions were usually immediate. Conclusions: This study successfully implemented EM provided by a solo practitioner in inpatient and emergent hospital settings and found that acceptability and demand justified its presence. Most patients experienced marked, immediate improvement of symptoms associated with their chief complaint. Substantial practicality issues must be addressed to implement EM clinically in a hospital, however. PMID:26035025

Feasibility and Clinical Utility of High-definition Transcranial Direct Current Stimulation in the Treatment of Persistent Hallucinations in Schizophrenia.

PubMed

Bose, A; Shivakumar, V; Chhabra, H; Parlikar, R; Sreeraj, V S; Dinakaran, D; Narayanaswamy, J C; Venkatasubramanian, G

2017-12-01

Persistent auditory verbal hallucination is a clinically significant problem in schizophrenia. Recent studies suggest a promising role for add-on transcranial direct current stimulation (tDCS) in treatment. An optimised version of tDCS, namely high-definition tDCS (HD-tDCS), uses smaller electrodes arranged in a 4x1 ring configuration and may offer more focal and predictable neuromodulation than conventional tDCS. This case report illustrates the feasibility and clinical utility of add-on HD-tDCS over the left temporoparietal junction in a 4x1 ring configuration to treat persistent auditory verbal hallucination in schizophrenia.

Sequencing of intraductal biopsies is feasible and potentially impacts clinical management of patients with indeterminate biliary stricture and cholangiocarcinoma.

PubMed

Bankov, Katrin; Döring, Claudia; Schneider, Markus; Hartmann, Sylvia; Winkelmann, Ria; Albert, Joerg G; Bechstein, Wolf Otto; Zeuzem, Stefan; Hansmann, Martin Leo; Peveling-Oberhag, Jan; Walter, Dirk

2018-04-30

Definite diagnosis and therapeutic management of cholangiocarcinoma (CCA) remains a challenge. The aim of the current study was to investigate feasibility and potential impact on clinical management of targeted sequencing of intraductal biopsies. Intraductal biopsies with suspicious findings from 16 patients with CCA in later clinical course were analyzed with targeted sequencing including tumor and control benign tissue (n = 55 samples). A CCA-specific sequencing panel containing 41 genes was designed and a dual strand targeted enrichment was applied. Sequencing was successfully performed for all samples. In total, 79 mutations were identified and a mean of 1.7 mutations per tumor sample (range 0-4) as well as 2.3 per biopsy (0-6) were detected and potentially therapeutically relevant genes were identified in 6/16 cases. In 14/18 (78%) biopsies with dysplasia or inconclusive findings at least one mutation was detected. The majority of mutations were found in both surgical specimen and biopsy (68%), while 28% were only present in biopsies in contrast to 4% being only present in the surgical tumor specimen. Targeted sequencing from intraductal biopsies is feasible and potentially improves the diagnostic yield. A profound genetic heterogeneity in biliary dysplasia needs to be considered in clinical management and warrants further investigation. The current study is the first to demonstrate the feasibility of sequencing of intraductal biopsies which holds the potential to impact diagnostic and therapeutical management of patients with biliary dysplasia and neoplasia.

A feasibility study of a theory-based intervention to improve appropriate polypharmacy for older people in primary care.

PubMed

Cadogan, Cathal A; Ryan, Cristín; Gormley, Gerard J; Francis, Jill J; Passmore, Peter; Kerse, Ngaire; Hughes, Carmel M

2018-01-01

A general practitioner (GP)-targeted intervention aimed at improving the prescribing of appropriate polypharmacy for older people was previously developed using a systematic, theory-based approach based on the UK Medical Research Council's complex intervention framework. The primary intervention component comprised a video demonstration of a GP prescribing appropriate polypharmacy during a consultation with an older patient. The video was delivered to GPs online and included feedback emphasising the positive outcomes of performing the behaviour. As a complementary intervention component, patients were invited to scheduled medication review consultations with GPs. This study aimed to test the feasibility of the intervention and study procedures (recruitment, data collection). GPs from two general practices were given access to the video, and reception staff scheduled consultations with older patients receiving polypharmacy (≥4 medicines). Primary feasibility study outcomes were the usability and acceptability of the intervention to GPs. Feedback was collected from GP and patient participants using structured questionnaires. Clinical data were also extracted from recruited patients' medical records (baseline and 1 month post-consultation). The feasibility of applying validated assessment of prescribing appropriateness (STOPP/START criteria, Medication Appropriateness Index) and medication regimen complexity (Medication Regimen Complexity Index) to these data was investigated. Data analysis was descriptive, providing an overview of participants' feedback and clinical assessment findings. Four GPs and ten patients were recruited across two practices. The intervention was considered usable and acceptable by GPs. Some reservations were expressed by GPs as to whether the video truly reflected resource and time pressures encountered in the general practice working environment. Patient feedback on the scheduled consultations was positive. Patients welcomed the opportunity to have their medications reviewed. Due to the short time to follow-up and a lack of detailed clinical information in patient records, it was not feasible to detect any prescribing changes or to apply the assessment tools to patients' clinical data. The findings will help to further refine the intervention and study procedures (including time to follow-up) which will be tested in a randomised pilot study that will inform the design of a definitive trial to evaluate the intervention's effectiveness. ISRCTN18176245.

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

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

2014-03-01

This study was conducted 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. 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 1 or 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). 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 pairwise comparisons found significant difference between baseline and week 6 in content-specific knowledge scores among participants in the Late Group [79% versus 92.1%, p = 0.01). Global knowledge scores increased significantly for variables reflecting knowledge that promotes decisions to participate in clinical trials. 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.

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.

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

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.

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 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

78 FR 19489 - Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Initial Review

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-01

..., Special Interest Project (SIP)13-067; and Feasibility Study of the New Clinical Measure of Colorectal... Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92-463... ``Understanding the Barriers to Colorectal Cancer Screening among Asian Subgroups, SIP13-067; and Feasibility...

A Pilot Study of Adjunctive Family Psychoeducation in Adolescent Major Depression: Feasibility and Treatment Effect

ERIC Educational Resources Information Center

Sanford, Mark; Boyle, Michael; McCleary, Lynn; Miller, Jennifer; Steele, Margaret; Duku, Eric; Offord, David

2006-01-01

Objective: To obtain preliminary evidence of the feasibility and effectiveness of adjunctive family psychoeducation in adolescent major depressive disorder. Method: Participants were from outpatient clinics in Hamilton and London, Ontario. Over 24 months, 41 adolescents ages 13 through 18 years meeting major depressive disorder criteria were…

A Study Investigating the Feasibility of Creating a Short Form of the WISC-R for Disabled Readers.

ERIC Educational Resources Information Center

Brown, David M.; Otts, David A.

The purpose of this study was to investigate the feasibility of creating a short form of the Wechsler Intelligence Scale for Children-Revised (WISC-R) for use in a clinical setting with disabled readers. The subjects were 100 clients ages six to sixteen of the Belser-Parton Reading Center at the University of Alabama whose files contained scores…

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.

[Feasibility Study on Digital Signal Processor and Gear Pump of Uroflowmeter Calibration Device].

PubMed

Yuan, Qing; Ji, Jun; Gao, Jiashuo; Wang, Lixin; Xiao, Hong

2016-08-01

It will cause hidden trouble on clinical application if the uroflowmeter is out of control.This paper introduces a scheme of uroflowmeter calibration device based on digital signal processor(DSP)and gear pump and shows studies of its feasibility.According to the research plan,we analyzed its stability,repeatability and linearity by building a testing system and carried out experiments on it.The flow test system is composed of DSP,gear pump and other components.The test results showed that the system could produce a stable water flow with high precision of repeated measurement and different flow rate.The test system can calibrate the urine flow rate well within the range of 9~50mL/s which has clinical significance,and the flow error is less than 1%,which meets the technical requirements of the calibration apparatus.The research scheme of uroflowmeter calibration device on DSP and gear pump is feasible.

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.

Development of regional chemotherapies: feasibility, safety and efficacy in clinical use and preclinical studies

PubMed Central

Cai, Shuang; Bagby, Taryn R; Forrest, M Laird

2011-01-01

Conventional oral and intravenous chemotherapies permeate throughout the body, exposing healthy tissues to similar cytotoxic drug levels as tumors. This leads to significant dose-limiting toxicities that may prevent patients from receiving sufficient treatment to overcome cancers. Therefore, a number of locoregional drug-delivery strategies have been evaluated and implemented in preclinical studies, clinical trials and in practice, in the past decades to minimize systemic toxicities from chemotherapeutic agents and to improve treatment outcomes. Localized treatment is beneficial because many cancers, such as melanoma, peritoneal cancer and breast cancer, advance locally adjacent to the site of the primary tumors prior to their circulatory invasion. In this article, we will review the feasibility, safety and efficacy of multiple localized chemotherapies in clinical use and preclinical development. PMID:22229080

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

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

Federal Register 2010, 2011, 2012, 2013, 2014

2013-07-09

... DEPARTMENT OF VETERANS AFFAIRS Clinical Science Research and Development Service Cooperative... under the Federal Advisory Committee Act, 5 U.S.C. App. 2, that the Clinical Science Research and... Science Research and Development Service on the relevance and feasibility of proposed projects and the...

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.

Novel System for Real-Time Integration of 3-D Echocardiography and Fluoroscopy for Image-Guided Cardiac Interventions: Preclinical Validation and Clinical Feasibility Evaluation.

PubMed

Arujuna, Aruna V; Housden, R James; Ma, Yingliang; Rajani, Ronak; Gao, Gang; Nijhof, Niels; Cathier, Pascal; Bullens, Roland; Gijsbers, Geert; Parish, Victoria; Kapetanakis, Stamatis; Hancock, Jane; Rinaldi, C Aldo; Cooklin, Michael; Gill, Jaswinder; Thomas, Martyn; O'neill, Mark D; Razavi, Reza; Rhode, Kawal S

2014-01-01

Real-time imaging is required to guide minimally invasive catheter-based cardiac interventions. While transesophageal echocardiography allows for high-quality visualization of cardiac anatomy, X-ray fluoroscopy provides excellent visualization of devices. We have developed a novel image fusion system that allows real-time integration of 3-D echocardiography and the X-ray fluoroscopy. The system was validated in the following two stages: 1) preclinical to determine function and validate accuracy; and 2) in the clinical setting to assess clinical workflow feasibility and determine overall system accuracy. In the preclinical phase, the system was assessed using both phantom and porcine experimental studies. Median 2-D projection errors of 4.5 and 3.3 mm were found for the phantom and porcine studies, respectively. The clinical phase focused on extending the use of the system to interventions in patients undergoing either atrial fibrillation catheter ablation (CA) or transcatheter aortic valve implantation (TAVI). Eleven patients were studied with nine in the CA group and two in the TAVI group. Successful real-time view synchronization was achieved in all cases with a calculated median distance error of 2.2 mm in the CA group and 3.4 mm in the TAVI group. A standard clinical workflow was established using the image fusion system. These pilot data confirm the technical feasibility of accurate real-time echo-fluoroscopic image overlay in clinical practice, which may be a useful adjunct for real-time guidance during interventional cardiac procedures.

Feasibility of encoding the Institute for Clinical Systems Improvement Depression Guideline using the Omaha System.

PubMed

Monsen, Karen A; Neely, Claire; Oftedahl, Gary; Kerr, Madeleine J; Pietruszewski, Pam; Farri, Oladimeji

2012-08-01

Evidence-based clinical guidelines are being developed to bridge the gap between research and practice with the goals of improving health care quality and population health. However, disseminating, implementing, and ensuring ongoing use of clinical guidelines in practice settings is challenging. The purpose of this study was to demonstrate the feasibility of encoding evidence-based clinical guidelines using the Omaha System. Clinical documentation with Omaha System-encoded guidelines generates individualized, meaningful data suitable for program evaluation and health care quality research. The use of encoded guidelines within the electronic health record has potential to reinforce use of guidelines, and thus improve health care quality and population health. Research using Omaha System data generated by clinicians has potential to discover new knowledge related to guideline use and effectiveness. Copyright © 2012 Elsevier Inc. All rights reserved.

Feasibility and Efficacy of the Nintendo Wii Gaming System to Improve Balance Performance Post-Stroke: Protocol of a Phase II Randomized Controlled Trial in an Inpatient Rehabilitation Setting.

PubMed

Bower, Kelly J; Clark, Ross A; McGinley, Jennifer L; Martin, Clarissa L; Miller, Kimberly J

2013-04-01

Balance deficits following stroke are common and debilitating. Commercially available gaming systems, such as the Nintendo(®) (Kyoto, Japan) Wii™, have been widely adopted clinically; however, there is limited evidence supporting their feasibility and efficacy for improving balance performance following stroke. The aim of this trial is to investigate the clinical feasibility and efficacy of using the Nintendo Wii gaming system as an adjunct to standard care to improve balance performance following stroke in an inpatient rehabilitation setting. Thirty participants undergoing inpatient stroke rehabilitation will be recruited into this Phase II, single-blind, randomized controlled trial. Participants will be allocated into a Balance or Upper Limb Group, and both groups will perform activities using the Nintendo Wii in addition to their standard care. Participants will attend three 45-minute sessions per week, for a minimum of 2 and a maximum of 4 weeks. The main focus of the study is to investigate the feasibility of the intervention protocol. This will be evaluated through recruitment, retention, adherence, acceptability, and safety. The Step Test and Functional Reach Test will be the primary efficacy outcomes. Secondary outcomes will include force platform, mobility, and upper limb measures. Assessments will occur at baseline, 2 weeks, and 4 weeks after study entry. To the authors' knowledge, this will be the largest randomized clinical trial to investigate the feasibility and efficacy of the Nintendo Wii gaming system for improving balance performance in a stroke population. The results will inform the design of a Phase III multicenter trial.

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

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 randomized controlled pilot study feasibility of a tablet-based guided audio-visual relaxation intervention for reducing stress and pain in adults with sickle cell disease.

PubMed

Ezenwa, Miriam O; Yao, Yingwei; Engeland, Christopher G; Molokie, Robert E; Wang, Zaijie Jim; Suarez, Marie L; Wilkie, Diana J

2016-06-01

To test feasibility of a guided audio-visual relaxation intervention protocol for reducing stress and pain in adults with sickle cell disease. Sickle cell pain is inadequately controlled using opioids, necessitating further intervention such as guided relaxation to reduce stress and pain. Attention-control, randomized clinical feasibility pilot study with repeated measures. Randomized to guided relaxation or control groups, all patients recruited between 2013-2014 during clinical visits, completed stress and pain measures via a Galaxy Internet-enabled Android tablet at the Baseline visit (pre/post intervention), 2-week posttest visit and also daily at home between the two visits. Experimental group patients were asked to use a guided relaxation intervention at the Baseline visit and at least once daily for 2 weeks. Control group patients engaged in a recorded sickle cell discussion at the Baseline visit. Data were analysed using linear regression with bootstrapping. At baseline, 27/28 of consented patients completed the study protocol. Group comparison showed that guided relaxation significantly reduced current stress and pain. At the 2-week posttest, 24/27 of patients completed the study, all of whom reported liking the study. Patients completed tablet-based measures on 71% of study days (69% in control group, 72% in experiment group). At the 2-week posttest, the experimental group had significantly lower composite pain index scores, but the two groups did not differ significantly on stress intensity. This study protocol appears feasible. The tablet-based guided relaxation intervention shows promise for reducing sickle cell pain and warrants a larger efficacy trial. The ClinicalTrials.gov Identifier is: NCT02501447. © 2016 John Wiley & Sons Ltd.

76 FR 67748 - Center for Scientific Review; Notice of Closed Meeting

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-02

... and Feasibility Clinical Research Studies in Digestive. Diseases and Nutrition. Date: November 14..., Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93.393-93.396, 93.837-93.844, 93.846...

MRI of the hip at 7T: feasibility of bone microarchitecture, high-resolution cartilage, and clinical imaging.

PubMed

Chang, Gregory; Deniz, Cem M; Honig, Stephen; Egol, Kenneth; Regatte, Ravinder R; Zhu, Yudong; Sodickson, Daniel K; Brown, Ryan

2014-06-01

To demonstrate the feasibility of performing bone microarchitecture, high-resolution cartilage, and clinical imaging of the hip at 7T. This study had Institutional Review Board approval. Using an 8-channel coil constructed in-house, we imaged the hips of 15 subjects on a 7T magnetic resonance imaging (MRI) scanner. We applied: 1) a T1-weighted 3D fast low angle shot (3D FLASH) sequence (0.23 × 0.23 × 1-1.5 mm(3) ) for bone microarchitecture imaging; 2) T1-weighted 3D FLASH (water excitation) and volumetric interpolated breath-hold examination (VIBE) sequences (0.23 × 0.23 × 1.5 mm(3) ) with saturation or inversion recovery-based fat suppression for cartilage imaging; 3) 2D intermediate-weighted fast spin-echo (FSE) sequences without and with fat saturation (0.27 × 0.27 × 2 mm) for clinical imaging. Bone microarchitecture images allowed visualization of individual trabeculae within the proximal femur. Cartilage was well visualized and fat was well suppressed on FLASH and VIBE sequences. FSE sequences allowed visualization of cartilage, the labrum (including cartilage and labral pathology), joint capsule, and tendons. This is the first study to demonstrate the feasibility of performing a clinically comprehensive hip MRI protocol at 7T, including high-resolution imaging of bone microarchitecture and cartilage, as well as clinical imaging. Copyright © 2013 Wiley Periodicals, Inc.

Monolingual or Bilingual Intervention for Primary Language Impairment? A Randomized Control Trial

ERIC Educational Resources Information Center

Thordardottir, Elin; Cloutier, Geneviève; Ménard, Suzanne; Pelland-Blais, Elaine; Rvachew, Susan

2015-01-01

Purpose: This study investigated the clinical effectiveness of monolingual versus bilingual language intervention, the latter involving speech-language pathologist-parent collaboration. The study focuses on methods that are currently being recommended and that are feasible within current clinical contexts. Method: Bilingual children with primary…

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

The role of point of care ultrasound in prehospital critical care: a systematic review.

PubMed

Bøtker, Morten Thingemann; Jacobsen, Lars; Rudolph, Søren Steemann; Knudsen, Lars

2018-06-26

In 2011, the role of Point of Care Ultrasound (POCUS) was defined as one of the top five research priorities in physician-provided prehospital critical care and future research topics were proposed; the feasibility of prehospital POCUS, changes in patient management induced by POCUS and education of providers. This systematic review aimed to assess these three topics by including studies examining all kinds of prehospital patients undergoing all kinds of prehospital POCUS examinations and studies examining any kind of POCUS education in prehospital critical care providers. By a systematic literature search in MEDLINE, EMBASE, and Cochrane databases, we identified and screened titles and abstracts of 3264 studies published from 2012 to 2017. Of these, 65 studies were read in full-text for assessment of eligibility and 27 studies were ultimately included and assessed for quality by SIGN-50 checklists. No studies compared patient outcome with and without prehospital POCUS. Four studies of acceptable quality demonstrated feasibility and changes in patient management in trauma. Two studies of acceptable quality demonstrated feasibility and changes in patient management in breathing difficulties. Four studies of acceptable quality demonstrated feasibility, outcome prediction and changes in patient management in cardiac arrest, but also that POCUS may prolong pauses in compressions. Two studies of acceptable quality demonstrated that short (few hours) teaching sessions are sufficient for obtaining simple interpretation skills, but not image acquisition skills. Three studies of acceptable quality demonstrated that longer one- or two-day courses including hands-on training are sufficient for learning simple, but not advanced, image acquisition skills. Three studies of acceptable quality demonstrated that systematic educational programs including supervised examinations are sufficient for learning advanced image acquisition skills in healthy volunteers, but that more than 50 clinical examinations are required for expertise in a clinical setting. Prehospital POCUS is feasible and changes patient management in trauma, breathing difficulties and cardiac arrest, but it is unknown if this improves outcome. Expertise in POCUS requires extensive training by a combination of theory, hands-on training and a substantial amount of clinical examinations - a large part of these needs to be supervised.

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.

A feasibility study investigating the acceptability and design of a multicentre randomised controlled trial of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contractures of the fingers (HAND-1): study protocol for a randomised controlled trial.

PubMed

Harrison, Eleanor; Tan, Wei; Mills, Nicola; Karantana, Alexia; Sprange, Kirsty; Duley, Lelia; Elliott, Daisy; Blazeby, Jane; Hollingworth, William; Montgomery, Alan A; Davis, Tim

2017-08-25

Dupuytren's contractures are fibrous cords under the skin of the palm of the hand. The contractures are painless but cause one or more fingers to curl into the palm, resulting in loss of function. Standard treatment within the NHS is surgery to remove (fasciectomy) or divide (fasciotomy) the contractures, and the treatment offered is frequently determined by surgeon preference. This study aims to determine the feasibility of conducting a large, multicentre randomised controlled trial to assess the clinical and cost-effectiveness of needle fasciotomy versus limited fasciectomy for the treatment of Dupuytren's contracture. HAND-1 is a parallel, two-arm, multicentre, randomised feasibility trial. Eligible patients aged 18 years or over who have one or more fingers with a Dupuytren's contracture of more than 30° in the metacarpophalangeal (MCP) and/or proximal interphalangeal (PIP) joints, well-defined cord(s) causing contracture, and have not undergone previous surgery for Dupuytren's on the same hand will be randomised (1:1) to treatment with either needle fasciotomy or limited fasciectomy. Participants will be followed-up for up to 6 months post surgery. Feasibility outcomes include number of patients screened, consented and randomised, adherence with treatment, completion of follow-up and identification of an appropriate patient-reported outcome measure (PROM) to use as primary outcome for a main trial. Embedded qualitative research, incorporating a QuinteT Recruitment Intervention, will focus on understanding and optimising the recruitment process, and exploring patients' experiences of trial participation and the interventions. This study will assess whether a large multicentre trial comparing the clinical and cost-effectiveness of needle fasciotomy and limited fasciectomy for the treatment of Dupuytren's contractures is feasible, and if so will provide data to inform its design and successful conduct. International Standard Registered Clinical/soCial sTudy Number: ISRCTN11164292 . Registered on 28 August 2015.

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 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

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

The feasibility and acceptability of using a portfolio to assess professional competence.

PubMed

Miller, Patricia A; Tuekam, Rosine

2011-01-01

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. 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. 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). 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.

Feasibility of Conducting Autism Biomarker Research in the Clinical Setting.

PubMed

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

2017-09-01

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

Utility of the electronic information resource UpToDate for clinical decision-making at bedside rounds.

PubMed

Phua, J; See, K C; Khalizah, H J; Low, S P; Lim, T K

2012-02-01

Clinical questions often arise at daily hospital bedside rounds. Yet, little information exists on how the search for answers may be facilitated. The aim of this prospective study was, therefore, to evaluate the overall utility, including the feasibility and usefulness of incorporating searches of UpToDate, a popular online information resource, into rounds. Doctors searched UpToDate for any unresolved clinical questions during rounds for patients in general medicine and respiratory wards, and in the medical intensive care unit of a tertiary teaching hospital. The nature of the questions and the results of the searches were recorded. Searches were deemed feasible if they were completed during the rounds and useful if they provided a satisfactory answer. A total of 157 UpToDate searches were performed during the study period. Questions were raised by all ranks of clinicians from junior doctors to consultants. The searches were feasible and performed immediately during rounds 44% of the time. Each search took a median of three minutes (first quartile: two minutes, third quartile: five minutes). UpToDate provided a useful and satisfactory answer 75% of the time, a partial answer 17% of the time and no answer 9% of the time. It led to a change in investigations, diagnosis or management 37% of the time, confirmed what was originally known or planned 38% of the time and had no effect 25% of the time. Incorporating UpToDate searches into daily bedside rounds was feasible and useful in clinical decision-making.

Web-based, self-management enhancing interventions with e-diaries and personalized feedback for persons with chronic illness: a tale of three studies.

PubMed

Nes, Andréa A G; Eide, Hilde; Kristjánsdóttir, Ólöf Birna; van Dulmen, Sandra

2013-12-01

Chronic illness places high demands on patients. Interventions supporting self-management and providing personalized feedback might help patients to gain new perspectives and enhance use of constructive self-management strategies. We developed three comparable web-based CBT-grounded interventions including e-diaries and feedback delivered through PDAs/smartphones. The feasibility and efficacy of these interventions have been investigated for patients with irritable bowel syndrome (in an RCT), chronic widespread pain (RCT) and type 2 diabetes (feasibility study). This is a descriptive study that summarizes the content, feasibility and efficacy of the interventions and discusses issues relevant for implementing this type of web-based therapeutic interventions in clinical practice. The web-based interventions appear feasible, acceptable and supportive. In a short and midterm time frame, the interventions promote self-management. Booster sessions may be needed for prolonged effects. Given the physical and mental symptoms of the patients under study and the nature of the intervention, providers who deliver the feedback need a health care background and training in this specific way of counseling. The results of the three studies suggest that personalized web-based interventions are effective and have the potential to support self-management in daily healthcare. Studies concerning clinical significance and implementation are needed. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

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.

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

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

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

PubMed Central

Boland, Mary Regina; Miotto, Riccardo; Gao, Junfeng; Weng, Chunhua

2013-01-01

Summary Background 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. Objectives This study explores the feasibility of feature-based indexing, clustering, and search of clinical trials and informs designs to automate these processes. Methods 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. Results 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. Conclusions 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. PMID:23666475

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.

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

A novel suction/coagulation integrated probe for achieving better hemostasis: development and clinical use.

PubMed

Takahashi, Hidekazu; Haraguchi, Naotsugu; Nishimura, Junichi; Hata, Taishi; Matsuda, Chu; Yamamoto, Hirofumi; Mizushima, Tsunekazu; Mori, Masaki; Doki, Yuichiro; Nakajima, Kiyokazu

2018-06-01

Modern electrosurgical tools have a specific coagulation mode called "soft coagulation". However, soft coagulation has not been widely accepted for surgical operations. To optimize the soft coagulation environment, we developed a novel suction device integrated with an electrosurgical probe, called the "Suction ball coagulator" (SBC). In this study, we aimed to optimize the SBC design with a prototyping process involving a bench test and preclinical study; then, we aimed to demonstrate the feasibility, safety, and potential effectiveness of the SBC for laparoscopic surgery in clinical settings. SBC prototyping was performed with a bench test. Device optimization was performed in a preclinical study with a domestic swine bleeding model. Then, SBC was tested in a clinical setting during 17 clinical laparoscopic colorectal surgeries. In the bench tests, two tip hole sizes and patterns showed a good suction capacity. The preclinical study indicated the best tip shape for accuracy. In clinical use, no device-related adverse event was observed. Moreover, the SBC was feasible for prompt hemostasis and blunt dissections. In addition, SBC could evacuate vapors generated by tissue ablation using electroprobe during laparoscopic surgery. We successfully developed a novel, integrated suction/coagulation probe for hemostasis and commercialized it.

Multicenter Feasibility Study of Tumor Molecular Profiling to Inform Therapeutic Decisions in Advanced Pediatric Solid Tumors: The Individualized Cancer Therapy (iCat) Study.

PubMed

Harris, Marian H; DuBois, Steven G; Glade Bender, Julia L; Kim, AeRang; Crompton, Brian D; Parker, Erin; Dumont, Ian P; Hong, Andrew L; Guo, Dongjing; Church, Alanna; Stegmaier, Kimberly; Roberts, Charles W M; Shusterman, Suzanne; London, Wendy B; MacConaill, Laura E; Lindeman, Neal I; Diller, Lisa; Rodriguez-Galindo, Carlos; Janeway, Katherine A

2016-01-28

Pediatric cancers represent a unique case with respect to cancer genomics and precision medicine, as the mutation frequency is low, and targeted therapies are less available. Consequently, it is unknown whether clinical sequencing can be of benefit. To assess the feasibility of identifying actionable alterations and making individualized cancer therapy (iCat) recommendations in pediatric patients with extracranial solid tumors. Clinical sequencing study at 4 academic medical centers enrolling patients between September 5, 2012, and November 19, 2013, with 1 year of clinical follow-up. Participants were 30 years or younger with high-risk, recurrent, or refractory extracranial solid tumors. The data analysis was performed October 28, 2014. Tumor profiling performed on archived clinically acquired specimens consisted of mutation detection by a Sequenom assay or targeted next-generation sequencing and copy number assessment by array comparative genomic hybridization. Results were reviewed by a multidisciplinary expert panel, and iCat recommendations were made if an actionable alteration was present, and an appropriate drug was available. Feasibility was assessed using a 2-stage design based on the proportion of patients with recommendations. Of 100 participants (60 male; median [range] age, 13.4 [0.8-29.8] years), profiling was technically successful in 89 (89% [95% CI, 83%-95%]). Median (range) follow-up was 6.8 (2.0-23.6) months. Overall, 31 (31% [95% CI, 23%-41%]) patients received an iCat recommendation and 3 received matched therapy. The most common actionable alterations leading to an iCat recommendation were cancer-associated signaling pathway gene mutations (n = 10) and copy number alterations in MYC/MYCN (n = 6) and cell cycle genes (n = 11). Additional alterations with implications for clinical care but not resulting in iCat recommendations were identified, including mutations indicating the possible presence of a cancer predisposition syndrome and translocations suggesting a change in diagnosis. In total, 43 (43% [95% CI, 33%-53%]) participants had results with potential clinical significance. A multi-institution clinical genomics study in pediatric oncology is feasible and a substantial proportion of relapsed or refractory pediatric solid tumors have actionable alterations. clinicaltrials.gov Identifier: NCT01853345.

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

Caregiver Person-Centeredness and Behavioral Symptoms during Mealtime Interactions: Development and Feasibility of a Coding Scheme

PubMed Central

Gilmore-Bykovskyi, Andrea L.

2015-01-01

Mealtime behavioral symptoms are distressing and frequently interrupt eating for the individual experiencing them and others in the environment. In order to enable identification of potential antecedents to mealtime behavioral symptoms, a computer-assisted coding scheme was developed to measure caregiver person-centeredness and behavioral symptoms for nursing home residents with dementia during mealtime interactions. The purpose of this pilot study was to determine the acceptability and feasibility of procedures for video-capturing naturally-occurring mealtime interactions between caregivers and residents with dementia, to assess the feasibility, ease of use, and inter-observer reliability of the coding scheme, and to explore the clinical utility of the coding scheme. Trained observers coded 22 observations. Data collection procedures were feasible and acceptable to caregivers, residents and their legally authorized representatives. Overall, the coding scheme proved to be feasible, easy to execute and yielded good to very good inter-observer agreement following observer re-training. The coding scheme captured clinically relevant, modifiable antecedents to mealtime behavioral symptoms, but would be enhanced by the inclusion of measures for resident engagement and consolidation of items for measuring caregiver person-centeredness that co-occurred and were difficult for observers to distinguish. PMID:25784080

Irreversible electroporation of the pancreas is feasible and safe in a porcine survival model.

PubMed

Fritz, Stefan; Sommer, Christof M; Vollherbst, Dominik; Wachter, Miguel F; Longerich, Thomas; Sachsenmeier, Milena; Knapp, Jürgen; Radeleff, Boris A; Werner, Jens

2015-07-01

Use of thermal tumor ablation in the pancreatic parenchyma is limited because of the risk of pancreatitis, pancreatic fistula, or hemorrhage. This study aimed to evaluate the feasibility and safety of irreversible electroporation (IRE) in a porcine model. Ten pigs were divided into 2 study groups. In the first group, animals received IRE of the pancreatic tail and were killed after 60 minutes. In the second group, animals received IRE at the head of the pancreas and were followed up for 7 days. Clinical parameters, computed tomography imaging, laboratory results, and histology were obtained. All animals survived IRE ablation, and no cardiac adverse effects were noted. Sixty minutes after IRE, a hypodense lesion on computed tomography imaging indicated the ablation zone. None of the animals developed clinical signs of acute pancreatitis. Only small amounts of ascites fluid, with a transient increase in amylase and lipase levels, were observed, indicating that no pancreatic fistula occurred. This porcine model shows that IRE is feasible and safe in the pancreatic parenchyma. Computed tomography imaging reveals significant changes at 60 minutes after IRE and therefore might serve as an early indicator of therapeutic success. Clinical studies are needed to evaluate the efficacy of IRE in pancreatic cancer.

Echocardiography-based hemodynamic management of left ventricular diastolic dysfunction: a feasibility and safety study.

PubMed

Shillcutt, Sasha K; Montzingo, Candice R; Agrawal, Ankit; Khaleel, Maseeha S; Therrien, Stacey L; Thomas, Walker R; Porter, Thomas R; Brakke, Tara R

2014-11-01

Patients with left ventricular diastolic dysfunction (LVDD) are at increased risk of postoperative adverse events. The primary aim of this study was to evaluate the safety and feasibility of using echocardiography-guided hemodynamic management (EGHEM) during surgery in subjects with LVDD compared to conventional management. The feasibility of using echocardiography to direct a treatment algorithm and clinical outcomes were compared for safety between groups. Subjects were screened for LVDD by preoperative transthoracic echocardiography (TTE) and randomized to the conventional or EGHEM group. Subjects in EGHEM received hemodynamic management based on left ventricular filling patterns on transesophageal echocardiography (TEE). Primary outcomes measured were the feasibility to obtain TEE images and follow a TEE-based treatment algorithm. Safety outcomes also compared the following clinical differences between groups: length of hospitalization, incidence of atrial fibrillation, congestive heart failure (CHF), myocardial infarction, cerebrovascular accident, transient ischemic attack and renal failure measured 30 days postoperatively. Population consisted of 28 surgical subjects (14 in conventional group and 14 in EGHEM group). Mean subject age was 73.4 ± 6.7 years (36% male) in conventional group and 65.9 ± 14.4 years (36% male) in EGHEM group. Procedures included orthopedic (conventional = 29%, EGHEM 36%), general (conventional = 50%, EGHEM = 36%), vascular (conventional = 7%, EGHEM = 21%), and thoracic (conventional = 14%, EGHEM = 7%). There was no statistically significant difference in adverse clinical events between the 2 groups. The EGHEM group had less CHF, atrial fibrillation, and shorter length of stay. Echocardiography-guided hemodynamic management of patients with LVDD during surgery is feasible and may be a safe alternative to conventional management. © 2014, Wiley Periodicals, Inc.

A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis.

PubMed

Koley, Munmun; Saha, Subhranil; Ghosh, Shubhamoy

2015-07-01

Few homeopathic complexes seemed to produce significant effects in osteoarthritis; still, individualized homeopathy remained untested. We evaluated the feasibility of conducting an efficacy trial of individualized homeopathy in osteoarthritis. A prospective, parallel-arm, double-blind, randomized, placebo-controlled pilot study was conducted from January to October 2014 involving 60 patients (homeopathy, n = 30; placebo, n = 30) who were suffering from acute painful episodes of knee osteoarthritis and visiting the outpatient clinic of Mahesh Bhattacharyya Homeopathic Medical College and Hospital, West Bengal, India. Statistically significant reduction was achieved in 3 visual analog scales (measuring pain, stiffness, and loss of function) and Osteoarthritis Research Society International scores in both groups over 2 weeks (P < .05); however, group differences were not significant (P > .05). Overall, homeopathy did not appear to be superior to placebo; still, further rigorous evaluation in this design involving a larger sample size seems feasible in future. Clinical Trials Registry, India (CTRI/2014/05/004589). © The Author(s) 2015.

[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.

Clinical feasibility study of protrach dualcare a new speaking valve with heat and moisture exchanger for tracheotomized patients.

PubMed

de Kleijn, B J; van As-Brooks, C J; Wedman, J; van der Laan, B F A M

2017-12-01

The aim of this study was to evaluate the clinical feasibility of the ProTrach DualCare (Atos Medical, Hörby, Sweden), a device combining a hands-free speaking valve and a Heat and Moisture Exchanger (HME) for tracheotomized patients. A non-randomized, prospective single center feasibility study. Sixteen adult tracheotomized patients were included. Participants were asked to test the DualCare for two weeks while continuing their normal activities. After these two weeks, participants could choose whether or not to take part in the long-term evaluation. The EuroQOL-5D, Borg scale and questionnaires on speaking, pulmonary function and patient preference were used. During the long-term evaluation, a minor redesign was implemented and all participants were asked to test the new device again for one week, with a potential long-term evaluation. Eleven decided to participate. The device was well-tolerated. Speaking noise was reduced ( p  = 0.020) and speech was considered to sound more natural compared to previously used devices according to the users ( p  = 0.020). Overall 11 participants preferred the DualCare to their standard device. No serious adverse events were reported. Overall, 11 of 16 participants preferred the DualCare to their standard speaking valve or HME. Users of the DualCare were able to use hands free speech with the benefits of an HME and the device was considered clinically feasible and has the potential to improve quality of life of tracheotomized patients. 2b.

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

Conventional Cognitive Behavioral Therapy Facilitated by an Internet-Based Support System: Feasibility Study at a Psychiatric Outpatient Clinic.

PubMed

Månsson, Kristoffer Nt; Klintmalm, Hugo; Nordqvist, Ragnar; Andersson, Gerhard

2017-08-24

Cognitive behavioral therapies have been shown to be effective for a variety of psychiatric and somatic disorders, but some obstacles can be noted in regular psychiatric care; for example, low adherence to treatment protocols may undermine effects. Treatments delivered via the Internet have shown promising results, and it is an open question if the blend of Internet-delivered and conventional face-to-face cognitive behavioral therapies may help to overcome some of the barriers of evidence-based treatments in psychiatric care. We evaluated the feasibility of an Internet-based support system at an outpatient psychiatric clinic in Sweden. For instance, the support system made it possible to send messages and share information between the therapist and the patient before and after therapy sessions at the clinic. Nine clinical psychologists participated and 33 patients were enrolled in the current study. We evaluated the usability and technology acceptance after 12 weeks of access. Moreover, clinical data on common psychiatric symptoms were assessed before and after the presentation of the support system. In line with our previous study in a university setting, the Internet-based support system has the potential to be feasible also when delivered in a regular psychiatric setting. Notably, some components in the system were less frequently used. We also found that patients improved on common outcome measures for depressive and anxious symptoms (effect sizes, as determined by Cohen d, ranged from 0.20-0.69). This study adds to the literature suggesting that modern information technology could be aligned with conventional face-to-face services. ©Kristoffer NT Månsson, Hugo Klintmalm, Ragnar Nordqvist, Gerhard Andersson. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 24.08.2017.

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.

Feasibility of developing a pediatric telehealth network in Honduras with international consultation support.

PubMed

Brooks, Mary; Holden, Kenton R; Durón, Reyna M; McElligott, James T; Summer, Andrea

2017-01-01

Honduras is the second poorest country in Central America, and roughly 50% of the population lives in rural areas. A telehealth network linking these areas to larger health centers may improve patient access to care, and physician access to educational opportunities. This pilot study assessed the feasibility of establishing a pediatric telehealth network between underserved clinics in Honduras and the Medical University of South Carolina (MUSC). Two underserved Honduran clinics were identified and invited to participate in the telehealth network. Providers from these clinics connected remotely to educational conferences at MUSC, and received teleconsults from MUSC physicians and physicians from the other Honduran site. Honduran providers completed five-point Likert scale satisfaction surveys following participation in the conferences and teleconsults. Survey feedback was positive, with 100% of respondents stating they would utilize telemedicine in the future. Dissatisfaction was expressed subjectively in the survey comments with regards to poor Internet connectivity and unreliable electrical power. The establishment of a telehealth network between Honduras and MUSC is feasible, and rural providers were receptive to the clinical and educational opportunities this network provides. Future projects will expand telehealth capabilities to other Honduran sites and focus on intra-country collaboration to ensure sustainability.

Do feasibility studies contribute to, or avoid, waste in research?

PubMed Central

Hejdenberg, Jennie; Hinrichs-Krapels, Saba; Armstrong, David

2018-01-01

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to ‘fail’. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research’s (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway. PMID:29684043

Do feasibility studies contribute to, or avoid, waste in research?

PubMed

Morgan, Ben; Hejdenberg, Jennie; Hinrichs-Krapels, Saba; Armstrong, David

2018-01-01

In the context of avoiding research waste, the conduct of a feasibility study before a clinical trial should reduce the risk that further resources will be committed to a trial that is likely to 'fail'. However, there is little evidence indicating whether feasibility studies add to or reduce waste in research. Feasibility studies funded by the National Institute for Health Research's (NIHR) Research for Patient Benefit (RfPB) programme were examined to determine how many had published their findings, how many had applied for further funding for a full trial and the timeframe in which both of these occurred. A total of 120 feasibility studies which had closed by May 2016 were identified and each Principal Investigator (PI) was sent a questionnaire of which 89 responses were received and deemed suitable for analysis. Based on self reported answers from the PIs a total of 57 feasibility studies were judged as feasible, 20 were judged not feasible and for 12 it was judged as uncertain whether a full trial was feasible. The RfPB programme had spent approximately £19.5m on the 89 feasibility studies of which 16 further studies had been subsequently funded to a total of £16.8m. The 20 feasibility studies which were judged as not feasible potentially saved up to approximately £20m of further research funding which would likely to have not completed successfully. The average RfPB feasibility study took 31 months (range 18 to 48) to complete and cost £219,048 (range £72,031 to £326,830) and the average full trial funded from an RfPB feasibility study took 42 months (range 26 to 55) to complete and cost £1,163,996 (range £321,403 to £2,099,813). The average timeframe of feasibility study and full trial was 72 months (range 56 to 91), however in addition to this time an average of 10 months (range -7 to 29) was taken between the end of the feasibility study and the application for the full trial, and a further average of 18 months (range 13 to 28) between the application for the full trial and the start of the full trial. Approximately 58% of the 89 feasibility studies had published their findings with the majority of the remaining studies still planning to publish. Due to the long time frames involved a number of studies were still in the process of publishing the feasibility findings and/or applying for a full trial. Feasibility studies are potentially useful at avoiding waste and de-risking funding investments of more expensive full trials, however there is a clear time delay and therefore some potential waste in the existing research pathway.

Cervical cancer screening: Safety, acceptability, and feasibility of a single-visit approach in Bulawayo, Zimbabwe.

PubMed

Fallala, Muriel S; Mash, Robert

2015-05-05

Cervical cancer is the commonest cancer amongst African women, and yet preventative services are often inadequate. The purpose of the study was to assess the safety, acceptability and feasibility of visual inspection with acetic acid and cervicography (VIAC) followed by cryotherapy or a loop electrical excision procedure (LEEP) at a single visit for prevention of cancer of the cervix. The United Bulawayo Hospital, Zimbabwe. The study was descriptive, using retrospective data extracted from electronic medical records of women attending the VIAC clinic. Over 24 months 4641 women visited the clinic and were screened for cervical cancer using VIAC. Cryotherapy or LEEP was offered immediately to those that screened positive. Treated women were followed up at three months and one year. The rate of positive results on VIAC testing was 10.8%. Of those who were eligible, 17.0% received immediate cryotherapy, 44.1% received immediate LEEP, 1.9% delayed treatment, and 37.0% were referred to a gynaecologist. No major complications were recorded after cryotherapy or LEEP. Amongst those treated 99.5% expressed satisfaction with their experience. Only 3.2% of those treated at the clinic had a positive result on VIAC one year later. The service was shown to be feasible to sustain over time with the necessary consumables. There were no service-related treatment postponements and the clinic staff and facility were able to meet the demand for the service. A single-visit approach using VIAC, followed by cryotherapy or LEEP, proved to be safe, acceptable and feasible in an urban African setting in Bulawayo, Zimbabwe. Outcomes a year later suggested that treatment had been effective.

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.

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

Acupuncture for treatment of hospital-induced constipation in children: a retrospective case series study.

PubMed

Anders, Eric Falk; Findeisen, Annette; Nowak, Andreas; Rüdiger, Mario; Usichenko, Taras Ivanovich

2012-12-01

Acupuncture is a promising option in the treatment of functional bowel disorders. The aim of this study was to evaluate the feasibility and acceptance of acupuncture for the treatment of hospital-induced constipation (HIC) in children. Bilateral stimulation of acupuncture point LI11 was applied in 10 children with HIC using fixed indwelling acupuncture needles (0.9 mm long) before considering starting conventional local constipation therapy with laxative suppositories. The clinical records were studied retrospectively for feasibility, acceptance and effectiveness of acupuncture. Acupuncture was feasible in all children and application of the indwelling needles was tolerated without fear. Side effects were not observed. After a median of 3 days of HIC, all children defaecated within 2 h after LI11 stimulation. No patient required conventional local constipation therapy. Acupuncture for the treatment of HIC is feasible and acceptable. Its effect should be verified in a randomised controlled trial.

Is a high initial World Federation of Neurosurgery (WFNS) grade really associated with a poor clinical outcome in elderly patients with ruptured intracranial aneurysms treated with coiling?

PubMed

Iosif, Christina; Di Maria, Federico; Sourour, Nader; Degos, Vincent; Bonneville, Fabrice; Biondi, Alessandra; Jean, Betty; Colonne, Chantal; Nouet, Aurelien; Chiras, Jacques; Clarençon, Frédéric

2014-05-01

Coiling of ruptured intracranial aneurysms in elderly patients remains debatable in terms of technical feasibility and clinical outcome. In this observational cohort study we aimed to assess the technical feasibility, complication profile and clinical outcomes of elderly patients with subarachnoid hemorrhage (SAH) treated with endovascular therapy. The study included 59 consecutive patients (47 women) aged ≥70 years (mean age 76 years, range 71-84) admitted to our institution with SAH from January 2002 to July 2011. The patients were treated for 66 aneurysms (regular coiling: n=62 (94%), balloon-assisted technique: n=2 (3%), stent and coil technique: n=2 (3%)). World Federation of Neurosurgery (WFNS) grade at admission was 1 in 13 patients, 2 in 23 patients, 3 in 8 patients, 4 in 11 patients and 5 in 4 patients. We analysed data by univariate and multivariate statistical analyses with an emphasis on the initial clinical situation, complications and clinical outcome. The technical success rate was 98% with a procedure-related deficit rate of 10% and procedure-related death rate of 5%. The Glasgow Outcome Scale score at 6 months was 1 in 15 patients (25.4%), 2 in 8 patients (13.6%), 3 in 14 patients (23.7%), 4 in 11 patients (18.6%) and 5 in 11 patients (18.6%). Patients admitted with a high initial WFNS grade did not differ statistically in terms of clinical outcome. The final clinical outcome was not significantly correlated with age, initial Fisher score or procedure-related complications. Endovascular treatment of elderly patients with ruptured cerebral aneurysms is feasible, safe and beneficial regardless of the presenting WFNS score.

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

Implementing Single Source: The STARBRITE Proof-of-Concept Study

PubMed Central

Kush, Rebecca; Alschuler, Liora; Ruggeri, Roberto; Cassells, Sally; Gupta, Nitin; Bain, Landen; Claise, Karen; Shah, Monica; Nahm, Meredith

2007-01-01

Objective Inefficiencies in clinical trial data collection cause delays, increase costs, and may reduce clinician participation in medical research. In this proof-of-concept study, we examine the feasibility of using point-of-care data capture for both the medical record and clinical research in the setting of a working clinical trial. We hypothesized that by doing so, we could increase reuse of patient data, eliminate redundant data entry, and minimize disruption to clinic workflow. Design We developed and used a point-of-care electronic data capture system to record data during patient visits. The standards-based system was used for clinical research and to generate the clinic note for the medical record. The system worked in parallel with data collection procedures already in place for an ongoing multicenter clinical trial. Our system was iteratively designed after analyzing case report forms and clinic notes, and observing clinic workflow patterns and business procedures. Existing data standards from CDISC and HL7 were used for database insertion and clinical document exchange. Results Our system was successfully integrated into the clinic environment and used in two live test cases without disrupting existing workflow. Analyses performed during system design yielded detailed information on practical issues affecting implementation of systems that automatically extract, store, and reuse healthcare data. Conclusion Although subject to the limitations of a small feasibility study, our study demonstrates that electronic patient data can be reused for prospective multicenter clinical research and patient care, and demonstrates a need for further development of therapeutic area standards that can facilitate researcher use of healthcare data. PMID:17600107

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.

Feasibility of two modes of treatment delivery for child anxiety in primary care.

PubMed

Chavira, Denise A; Drahota, Amy; Garland, Ann F; Roesch, Scott; Garcia, Maritza; Stein, Murray B

2014-09-01

In this study, we examine the feasibility of cognitive behavior therapy (CBT) for children with anxiety in primary care, using two modes of treatment delivery. A total of 48 parents and youth (8-13) with anxiety disorders were randomly assigned to receive 10-sessions of CBT either delivered by a child anxiety specialist in the primary care clinic or implemented by the parent with therapist support by telephone (i.e., face-to-face or therapist-supported bibliotherapy). Feasibility outcomes including satisfaction, barriers to treatment participation, safety, and dropout were assessed. Independent evaluators, blind to treatment condition, administered the Anxiety Disorders Interview Schedule for Children (ADIS) and the Clinical Global Impression of Improvement (CGI-I) at baseline, post-treatment and 3-month follow-up; clinical self-report questionnaires were also administered. Findings revealed high satisfaction, low endorsement of barriers, low drop out rates, and no adverse events across the two modalities. According to the CGI-I, 58.3%-75% of participants were considered responders (i.e., much or very much improved) at the various time points. Similar patterns were found for remission from "primary anxiety disorder" and "all anxiety disorders" as defined by the ADIS. Clinically significant improvement was seen on the various parent and child self-report measures of anxiety. Findings suggest that both therapy modalities are feasible and associated with significant treatment gains in the primary care setting. (clinicaltrials.gov unique identifier: NCT00769925). Copyright © 2014 Elsevier Ltd. All rights reserved.

Advanced imaging technologies for mapping cadaveric lymphatic anatomy: magnetic resonance and computed tomography lymphangiography.

PubMed

Pan, W R; Rozen, W M; Stretch, J; Thierry, B; Ashton, M W; Corlett, R J

2008-09-01

Lymphatic anatomy has become increasingly clinically important as surgical techniques evolve for investigating and treating cancer metastases. However, due to limited anatomical techniques available, research in this field has been insufficient. The techniques of computed tomography (CT) and magnetic resonance (MR) lymphangiography have not been described previously in the imaging of cadaveric lymphatic anatomy. This preliminary work describes the feasibility of these advanced imaging technologies for imaging lymphatic anatomy. A single, fresh cadaveric lower limb underwent lymphatic dissection and cannulation utilizing microsurgical techniques. Contrast materials for both CT and MR studies were chosen based on their suitability for subsequent clinical use, and imaging was undertaken with a view to mapping lymphatic anatomy. Microdissection studies were compared with imaging findings in each case. Both MR-based and CT-based contrast media in current clinical use were found to be suitable for demonstrating cadaveric lymphatic anatomy upon direct intralymphatic injection. MR lymphangiography and CT lymphangiography are feasible modalities for cadaveric anatomical research for lymphatic anatomy. Future studies including refinements in scanning techniques may offer these technologies to the clinical setting.

A prospective trial of hyperbaric oxygen for chronic sequelae after brain injury (HYBOBI).

PubMed

Churchill, Susan; Weaver, Lindell K; Deru, Kayla; Russo, Antonietta A; Handrahan, Diana; Orrison, William W; Foley, John F; Elwell, Heather A

2013-01-01

Some practitioners advocate hyperbaric oxygen (HBO2) for sequelae following brain injury. This study assessed recruitment, tolerance and safety in preparation for a randomized clinical trial. Prospective, open-label feasibility study. Hyperbaric medicine department of a tertiary academic hospital. Participatory adult outpatients with problems from stroke (n=22), anoxia (13) or trauma (28) that occurred at least 12 months before enrollment, without contraindications to HBO2. Sixty-three participants enrolled in the study (21 females,42 males). Age was 45 +/- 16 years (18-76) and time from injury was 6.9 +/- 7.1 years (1.0-29.3). Fifty-three completed the study intervention, and 55 completed the assessment battery. PARTICIPANTS underwent 60 daily HBO2 sessions (1.5 atm abs, 100% oxygen, 60 minutes). Assessments were conducted at baseline, after the HBO2 course, and six months later. The prime outcome was feasibility. To estimate the immediate and long-term effects of HBO2, we assessed neuropsychological measures, questionnaires, neurologic exam and physical functioning measures. Some participants also had pre- and post-HBO2 speech evaluation (n=27) and neuroimaging (n=17). The study met our a priori definition for feasibility for recruitment, but 44% required additional time to complete the 60 sessions (up to 105 days). HBO2-related adverse events were rare and not serious. Although many participants reported improvement in symptoms (51% memory, 51% attention/concentration, 48% balance/coordination, 45% endurance, 20% sleep) post-HBO2, and 93% reported that they would participate in the study again, no standardized testing showed clinically important improvement. In the small subset of those undergoing neuroimaging, apparent improvement was observed in auditory functional MRI (8/13), MR spectroscopy (9/17) and brain perfusionby CT angiography (5/9). Conducting an HBO2 clinical trial in this population was feasible. Although many participants reported improvement, the lack of concurrent controls limits the strength of inferences from this trial, especially considering lack of change in standardized testing. The clinical relevance of neuroimaging changes is unknown. The findings of this study may indicate a need for caution when considering the broad application of HBO2 more than one year after brain injury due to stroke, severe TBI and anoxia, until there is more compelling evidence from carefully designed sham-controlled, blinded clinical trials.

Safety and feasibility of sublingual microcirculation assessment in the emergency department for civilian and military patients with traumatic haemorrhagic shock: a prospective cohort study

PubMed Central

Naumann, David N; Mellis, Clare; Smith, Iain M; Mamuza, Jasna; Skene, Imogen; Harris, Tim; Midwinter, Mark J; Hutchings, Sam D

2016-01-01

Objectives Sublingual microcirculatory monitoring for traumatic haemorrhagic shock (THS) may predict clinical outcomes better than traditional blood pressure and cardiac output, but is not usually performed until the patient reaches the intensive care unit (ICU), missing earlier data of potential importance. This pilot study assessed for the first time the feasibility and safety of sublingual video-microscopy for THS in the emergency department (ED), and whether it yields useable data for analysis. Setting A safety and feasibility assessment was undertaken as part of the prospective observational MICROSHOCK study; sublingual video-microscopy was performed at the UK-led Role 3 medical facility at Camp Bastion, Afghanistan, and in the ED in 3 UK Major Trauma Centres. Participants There were 15 casualties (2 military, 13 civilian) who presented with traumatic haemorrhagic shock with a median injury severity score of 26. The median age was 41; the majority (n=12) were male. The most common injury mechanism was road traffic accident. Primary and secondary outcome measures Safety and feasibility were the primary outcomes, as measured by lack of adverse events or clinical interruptions, and successful acquisition and storage of data. The secondary outcome was the quality of acquired video clips according to validated criteria, in order to determine whether useful data could be obtained in this emergency context. Results Video-microscopy was successfully performed and stored for analysis for all patients, yielding 161 video clips. There were no adverse events or episodes where clinical management was affected or interrupted. There were 104 (64.6%) video clips from 14 patients of sufficient quality for analysis. Conclusions Early sublingual microcirculatory monitoring in the ED for patients with THS is safe and feasible, even in a deployed military setting, and yields videos of satisfactory quality in a high proportion of cases. Further investigations of early microcirculatory behaviour in this context are warranted. Trial registration number NCT02111109. PMID:28003301

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

PubMed

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

2016-05-01

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

The 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.

Does the Cultural Formulation Interview for the fifth revision of the diagnostic and statistical manual of mental disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site.

PubMed

Aggarwal, Neil K; Desilva, Ravi; Nicasio, Andel V; Boiler, Marit; Lewis-Fernández, Roberto

2015-01-01

Cross-cultural mental health researchers often analyze patient explanatory models of illness to optimize service provision. The Cultural Formulation Interview (CFI) is a cross-cultural assessment tool released in May 2013 with DSM-5 to revise shortcomings from the DSM-IV Outline for Cultural Formulation (OCF). The CFI field trial took place in 6 countries, 14 sites, and with 321 patients to explore its feasibility, acceptability, and clinical utility with patients and clinicians. We sought to analyze if and how CFI feasibility, acceptability, and clinical utility were related to patient-clinician communication. We report data from the New York site which enrolled 7 clinicians and 32 patients in 32 patient-clinician dyads. We undertook a data analysis independent of the parent field trial by conducting content analyses of debriefing interviews with all participants (n = 64) based on codebooks derived from frameworks for medical communication and implementation outcomes. Three coders created codebooks, coded independently, established inter-rater coding reliability, and analyzed if the CFI affects medical communication with respect to feasibility, acceptability, and clinical utility. Despite racial, ethnical, cultural, and professional differences within our group of patients and clinicians, we found that promoting satisfaction through the interview, eliciting data, eliciting the patient's perspective, and perceiving data at multiple levels were common codes that explained how the CFI affected medical communication. We also found that all but two codes fell under the implementation outcome of clinical utility, two fell under acceptability, and none fell under feasibility. Our study offers new directions for research on how a cultural interview affects patient-clinician communication. Future research can analyze how the CFI and other cultural interviews impact medical communication in clinical settings with subsequent effects on outcomes such as medication adherence, appointment retention, and health condition.

Does the Cultural Formulation Interview (CFI) for the Fifth Revision of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site

PubMed Central

Aggarwal, Neil K.; DeSilva, Ravi; Nicasio, Andel V.; Boiler, Marit; Lewis-Fernández, Roberto

2014-01-01

Objectives Cross-cultural mental health researchers often analyze patient explanatory models of illness to optimize service provision. The Cultural Formulation Interview (CFI) is a cross-cultural assessment tool released in May 2013 with DSM-5 to revise shortcomings from the DSM-IV Outline for Cultural Formulation (OCF). The CFI field trial took place in 6 countries, 14 sites, and with 321 patients to explore its feasibility, acceptability, and clinical utility with patients and clinicians. We sought to analyze if and how CFI feasibility, acceptability, and clinical utility were related to patient-clinician communication. Design We report data from the New York site which enrolled 7 clinicians and 32 patients in 32 patient-clinician dyads. We undertook a data analysis independent of the parent field trial by conducting content analyses of debriefing interviews with all participants (n=64) based on codebooks derived from frameworks for medical communication and implementation outcomes. Three coders created codebooks, coded independently, established inter-rater coding reliability, and analyzed if the CFI affects medical communication with respect to feasibility, acceptability, and clinical utility. Results Despite racial, ethnic, cultural, and professional differences within our group of patients and clinicians, we found that promoting satisfaction through the interview, eliciting data, eliciting the patient’s perspective, and perceiving data at multiple levels were common codes that explained how the CFI affected medical communication. We also found that all but 2 codes fell under the implementation outcome of clinical utility, 2 fell under acceptability, and none fell under feasibility. Conclusion Our study offers new directions for research on how a cultural interview affects patient-clinician communication. Future research can analyze how the CFI and other cultural interviews impact medical communication in clinical settings with subsequent effects on outcomes such as medication adherence, appointment retention, and health condition. PMID:25372242

Feasibility of studying brain morphology in major depressive disorder with structural magnetic resonance imaging and clinical data from the electronic medical record: A pilot study

PubMed Central

Hoogenboom, Wouter S.; Perlis, Roy H.; Smoller, Jordan W.; Zeng-Treitler, Qing; Gainer, Vivian S.; Murphy, Shawn N.; Churchill, Susanne E.; Kohane, Isaac S.; Shenton, Martha E.; Iosifescu, Dan V.

2012-01-01

For certain research questions related to long-term outcomes or to rare disorders, designing prospective studies is impractical or prohibitively expensive. Such studies could instead utilize clinical and magnetic resonance imaging data (MRI) collected as part of routine clinical care, stored in the electronic medical record (EMR). Using major depressive disorder (MDD) as a disease model, we examined the feasibility of studying brain morphology and associations with remission using clinical and MRI data exclusively drawn from the EMR. Advanced automated tools were used to select MDD patients and controls from the EMR who had brain MRI data, but no diagnosed brain pathology. MDD patients were further assessed for remission status by review of clinical charts. Twenty MDD patients (eight full-remitters, six partial-remitters, and six non-remitters), and fifteen healthy control subjects met all study criteria for advanced morphometric analyses. Compared to controls, MDD patients had significantly smaller right rostral-anterior cingulate volume, and level of non-remission was associated with smaller left hippocampus and left rostral-middle frontal gyrus volume. The use of EMR data for psychiatric research may provide a timely and cost-effective approach with the potential to generate large study samples reflective of the real population with the illness studied. PMID:23149041

A pilot feasibility study of virtual patient simulation to enhance social work students' brief mental health assessment skills.

PubMed

Washburn, Micki; Bordnick, Patrick; Rizzo, Albert Skip

2016-10-01

This study presents preliminary feasibility and acceptability data on the use of virtual patient (VP) simulations to develop brief assessment skills within an interdisciplinary care setting. Results support the acceptability of technology-enhanced simulations and offer preliminary evidence for an association between engagement in VP practice simulations and improvements in diagnostic accuracy and clinical interviewing skills. Recommendations and next steps for research on technology-enhanced simulations within social work are discussed.

Feasibility of Incorporating Alternative Teaching Methods into Clinical Clerkships.

ERIC Educational Resources Information Center

Berman, Judith; And Others

1990-01-01

A study investigated the effectiveness of computer-assisted instruction, interactive video, and videotapes as alternative methods of instruction in clinical clerkship modules on diabetes and hypertension. The 17 participants were more interested in balancing time between patient contact and alternative teaching methods and had better knowledge,…

Manual acupuncture plus usual care versus usual care alone in the treatment of endometriosis-related chronic pelvic pain: study protocol for a randomised controlled feasibility study.

PubMed

Armour, Mike; Smith, Caroline A; Schabrun, Siobhan; Steiner, Genevieve Z; Zhu, Xiaoshu; Lawson, Kenny; Song, Jing

2018-01-01

Endometriosis is the most common cause of chronic pelvic pain worldwide. Non-surgical treatments are effective for only 30-50% of women and have a significant side effect burden that leads to high discontinuation rates. Surgery can be effective but is expensive and invasive, and symptoms tend to recur within 5 years. There is early evidence that acupuncture may be effective in treating endometriosis-related chronic pelvic pain, showing clinically significant analgesia. Both levels of inflammation and pain processing have been shown to be altered in women with chronic pelvic pain. Acupuncture has been shown to reduce inflammation and change central pain processing in other conditions, but research on women with endometriosis is currently lacking. The aim of this feasibility study is to provide data on recruitment rates, retention, appropriateness of outcome measures, minimal clinically important difference in numeric rated scales for pain and the potential effect of acupuncture on pain processing and markers of inflammation in endometriosis-related CPP. We will include women aged 18-45 years with a diagnosis of endometriosis via laparoscopy in the past 5 years. A total of 30 participants will be recruited and randomly allocated in a 1:1 ratio to receive acupuncture or usual care. Women in the acupuncture group will receive two 45-min treatment sessions per week for 8 weeks (total of 16 sessions). Women in the usual care group will continue with their current treatment regimen. The primary feasibility outcomes are recruitment rates, retention rates and the safety and acceptability of the intervention; secondary patient-centred outcomes include a change in 0-10 daily pelvic pain ratings, the Endometriosis Health Profile 30 (EHP-30) and changes in conditioned pain modulation, resting and task-related EEG activity and inflammatory markers. Analyses will be performed blind to group allocation. This is a two-armed, assessor blind, randomised controlled feasibility trial. Data will be compared at baseline and trial completion 8 weeks later. Outcomes from this feasibility study will inform a larger, fully powered clinical trial should the treatment show trends for potential effectiveness. Australian New Zealand Clinical Trials Registry, ACTRN12617000053325 (http://www.ANZCTR.org.au/ACTRN12617000053325.aspx).

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.

Developmental trajectories of infants and toddlers with good initial presentation following moderate or severe traumatic brain injury: a pilot clinical assessment project.

PubMed

Pomerleau, Geneviève; Hurteau, Anne-Marie; Parent, Line; Doucet, Katrine; Corbin-Berrigan, Laurie-Ann; Gagnon, Isabelle

2012-01-01

The purpose of this study was to review the feasibility and usefulness of instituting a clinical protocol of scheduled assessments for children after a moderate or severe traumatic brain injury (TBI) sustained before the age of 2 years and showing no immediate deficits at hospital discharge, as well as to explore the early developmental trajectories of these children. Exploratory analytical cohort study. Pediatric Trauma Center Out-patient services. 31 children were followed within the clinical protocol of scheduled assessments. The protocol included an immediate post-injury clinical assessment of infants who sustained a TBI and follow-up assessments at the ages of 9 months, 18 months (if injured prior to that age), 30 months, and 42 months. Domains assessed at each scheduled visit included hearing, speech and language, motor performance, personal social abilities, and adaptive behaviors. Clinicians reported few difficulties with scheduling or administering the assessments, maintaining a 67% participation rate at the end of the follow-up period, thus demonstrating the feasibility of the protocol in this population. Scores on the majority of formal tests showed high variability and 15-20% of children presented with clinically significant motor and/or language delays. By 42 months of age, difficulties with adaptive behavior and personal social abilities were identified in our sample of children when compared to published norms. Qualitative clinical findings from professionals identified between 25-50% of children with potential attentional difficulties throughout the follow-up period. Findings from this study demonstrate the feasibility of implementing a clinical protocol of assessment for infants and toddlers who sustain a TBI before the age of 2 years and present with no impairments at the time of discharge from hospital. Developmental problems in this population appear to be easier to identify later in the toddler years as opposed to immediately following the TBI, emphasizing the importance of providing screening for developmental issues in this population prior to school entry.

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

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.

A feasibility study of a 3-day basal-bolus insulin delivery device in individuals with type 2 diabetes.

PubMed

Mader, Julia K; Lilly, Leslie C; Aberer, Felix; Korsatko, Stefan; Strock, Ellie; Mazze, Roger S; Damsbo, Peter; Pieber, Thomas R

2014-05-01

This study tested the feasibility of transition from multiple daily injections (MDI) to a 3-day, basal-bolus insulin delivery device (PaQ) for type 2 diabetes (T2D). Twenty MDI-treated individuals with T2D with HbA(1c) ≤9% (75 mmol/mol) were enrolled in a single-center, single-arm pilot study, lasting three 2-week periods: baseline (MDI), transition to PaQ, and PaQ therapy. Feasibility of use, glycemic control, safety, and patient satisfaction were assessed. Nineteen participants transitioned to PaQ treatment and demonstrated competency in assembling, placing, and using the device. Self-monitored blood glucose and blinded continuous glucose-monitoring data showed glycemic control similar to MDI. Study participants reported high satisfaction and device acceptance. PaQ treatment is both feasible and acceptable in individuals with T2D. Transition from MDI is easy and safe. PaQ treatment might lead to better therapy adherence and improvements in glycemic control and clinical outcomes.

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.

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

A Comparison of the Pathogenesis of Marburg Virus Disease in Humans and Nonhuman Primates and Evaluation of the Suitability of These Animal Models for Predicting Clinical Efficacy under the 'Animal Rule'.

PubMed

Glaze, Elizabeth R; Roy, Michael J; Dalrymple, Lonnie W; Lanning, Lynda L

2015-06-01

Marburg virus outbreaks are sporadic, infrequent, brief, and relatively small in terms of numbers of subjects affected. In addition, outbreaks most likely will occur in remote regions where clinical trials are not feasible; therefore, definitive, well-controlled human efficacy studies to test the effectiveness of a drug or biologic product are not feasible. Healthy human volunteers cannot ethically be deliberately exposed to a lethal agent such as Marburg virus in order to test the efficacy of a therapy or preventive prior to licensure. When human efficacy studies are neither ethical nor feasible, the US Food and Drug Administration may grant marketing approval of a drug or biologic product under the 'Animal Rule,' through which demonstration of the efficacy of a product can be 'based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans.' This process requires that the pathogenic determinants of the disease in the animal model are similar to those that have been identified in humans. After reviewing primarily English-language, peer-reviewed journal articles, we here summarize the clinical manifestations of Marburg virus disease and the results of studies in NHP showing the characteristics and progression of the disease. We also include a detailed comparison of the characteristics of the human disease relative to those for NHP. This review reveals that the disease characteristics of Marburg virus disease are generally similar for humans and 3 NHP species: cynomolgus macaques (Macaca fascicularis), rhesus macaques (Macaca mulatta), and African green monkeys (Chlorocebus aethiops).

A Comparison of the Pathogenesis of Marburg Virus Disease in Humans and Nonhuman Primates and Evaluation of the Suitability of These Animal Models for Predicting Clinical Efficacy under the ‘Animal Rule’

PubMed Central

Glaze, Elizabeth R; Roy, Michael J; Dalrymple, Lonnie W; Lanning, Lynda L

2015-01-01

Marburg virus outbreaks are sporadic, infrequent, brief, and relatively small in terms of numbers of subjects affected. In addition, outbreaks most likely will occur in remote regions where clinical trials are not feasible; therefore, definitive, well-controlled human efficacy studies to test the effectiveness of a drug or biologic product are not feasible. Healthy human volunteers cannot ethically be deliberately exposed to a lethal agent such as Marburg virus in order to test the efficacy of a therapy or preventive prior to licensure. When human efficacy studies are neither ethical nor feasible, the US Food and Drug Administration may grant marketing approval of a drug or biologic product under the ‘Animal Rule,’ through which demonstration of the efficacy of a product can be ‘based on adequate and well-controlled animal efficacy studies when the results of those studies establish that the drug is reasonably likely to produce clinical benefit in humans.’ This process requires that the pathogenic determinants of the disease in the animal model are similar to those that have been identified in humans. After reviewing primarily English-language, peer-reviewed journal articles, we here summarize the clinical manifestations of Marburg virus disease and the results of studies in NHP showing the characteristics and progression of the disease. We also include a detailed comparison of the characteristics of the human disease relative to those for NHP. This review reveals that the disease characteristics of Marburg virus disease are generally similar for humans and 3 NHP species: cynomolgus macaques (Macaca fascicularis), rhesus macaques (Macaca mulatta), and African green monkeys (Chlorocebus aethiops). PMID:26141449

Rehabilitation technologies and interventions for individuals with spinal cord injury: translational potential of current trends.

PubMed

Musselman, Kristin E; Shah, Meeral; Zariffa, José

2018-05-16

In the past, neurorehabilitation for individuals with neurological damage, such as spinal cord injury (SCI), was focused on learning compensatory movements to regain function. Presently, the focus of neurorehabilitation has shifted to functional neurorecovery, or the restoration of function through repetitive movement training of the affected limbs. Technologies, such as robotic devices and electrical stimulation, are being developed to facilitate repetitive motor training; however, their implementation into mainstream clinical practice has not been realized. In this commentary, we examined how current SCI rehabilitation research aligns with the potential for clinical implementation. We completed an environmental scan of studies in progress that investigate a physical intervention promoting functional neurorecovery. We identified emerging interventions among the SCI population, and evaluated the strengths and gaps of the current direction of SCI rehabilitation research. Seventy-three study postings were retrieved through website and database searching. Study objectives, outcome measures, participant characteristics and the mode(s) of intervention being studied were extracted from the postings. The FAME (Feasibility, Appropriateness, Meaningfulness, Effectiveness, Economic Evidence) Framework was used to evaluate the strengths and gaps of the research with respect to likelihood of clinical implementation. Strengths included aspects of Feasibility, as the research was practical, aspects of Appropriateness as the research aligned with current scientific literature on motor learning, and Effectiveness, as all trials aimed to evaluate the effect of an intervention on a clinical outcome. Aspects of Feasibility were also identified as a gap; with two thirds of the studies examining emerging technologies, the likelihood of successful clinical implementation was questionable. As the interventions being studied may not align with the preferences of clinicians and priorities of patients, the Appropriateness of these interventions for the current health care environment was questioned. Meaningfulness and Economic Evidence were also identified as gaps since few studies included measures reflecting the perceptions of the participants or economic factors, respectively. The identified gaps will likely impede the clinical uptake of many of the interventions currently being studied. Future research may lessen these gaps through a staged approach to the consideration of the FAME elements as novel interventions and technologies are developed, evaluated and implemented.

A phase I/II clinical trial for the hybrid of intracavitary and interstitial brachytherapy for locally advanced cervical cancer.

PubMed

Murakami, Naoya; Kato, Shingo; Nakano, Takashi; Uno, Takashi; Yamanaka, Takeharu; Sakurai, Hideyuki; Yoshimura, Ryoichi; Hiratsuka, Junichi; Kuroda, Yuki; Yoshio, Kotaro; Itami, Jun

2016-08-17

This paper describes about a study protocol of phase I/II multicenter prospective clinical trial evaluating the feasibility and efficacy of the hybrid of intracavitary and interstitial brachytherapy (HBT) for locally advanced uterine cervical cancer patients. Patients with histologically confirmed FIGO stage IB2, IIA2, IIB, and IIIB uterine cervical carcinoma width of which is larger than 5 cm assessed by MRI will be entered to this clinical trial. Protocol therapy is 30-30.6 Gy in 15-17 fractions of whole pelvic radiotherapy concurrent with weekly CDDP (40 mg/m(2)), followed by 24 Gy in 4 fractions of HBT and central shield EBRT up to 50-50.4 Gy in 25-28 fractions. Tumor width is assessed again within one week before the first HBT and if the tumor width is larger than 4 cm, patients proceed to the secondary registration. In phase I section, feasibility of this will be investigated. If less than 10 % out of 20 patients experienced greater than grade 3 acute non-hematologic adverse effects, the study proceeds to phase II part. In phase II part a total of 55 patients will be accrued and the efficacy of the HBT will be investigated comparing with historical control data. If the lower margin of 90 % confidence interval of the 2-year pelvic progression-free survival of the HBT trial is higher than 64 %, the HBT is considered to be more effective than conventional ICBT. The aim of this study is to demonstrate the feasibility and efficacy of the HBT for locally advanced cervical cancer. This trial will clarify the indication, feasibility, and efficacy of this new technique. UMIN000019081 ; Registration date: 2015/9/30.

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.

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

Feasibility of a Manualized Occupation-Based Diabetes Management Intervention.

PubMed

Carandang, Kristine M; Pyatak, Elizabeth A

We investigated the feasibility and acceptability of an occupational therapy intervention targeting diabetes management for underserved young adults. Eight participants completed the intervention and a battery of assessments at baseline and after the intervention. At completion, the participants and occupational therapist were interviewed about their experiences with the study. Four categories of assessment questions were used to guide the study: process, resource, management, and scientific. Successes included recruitment; fulfillment of tasks by staff and partnering clinics; adequate space, financial support, and equipment; and meaningfulness of the intervention for participants. Challenges included scheduling participants for the intervention and follow-up focus groups and providing client centeredness and flexibility while reducing burden on the intervener. This feasibility study allowed us to make necessary revisions to our study protocol before implementing a larger pilot study. Copyright © 2018 by the American Occupational Therapy Association, Inc.

National audit of continence care: laying the foundation.

PubMed

Mian, Sarah; Wagg, Adrian; Irwin, Penny; Lowe, Derek; Potter, Jonathan; Pearson, Michael

2005-12-01

National audit provides a basis for establishing performance against national standards, benchmarking against other service providers and improving standards of care. For effective audit, clinical indicators are required that are valid, feasible to apply and reliable. This study describes the methods used to develop clinical indicators of continence care in preparation for a national audit. To describe the methods used to develop and test clinical indicators of continence care with regard to validity, feasibility and reliability. A multidisciplinary working group developed clinical indicators that measured the structure, process and outcome of care as well as case-mix variables. Literature searching, consensus workshops and a Delphi process were used to develop the indicators. The indicators were tested in 15 secondary care sites, 15 primary care sites and 15 long-term care settings. The process of development produced indicators that received a high degree of consensus within the Delphi process. Testing of the indicators demonstrated an internal reliability of 0.7 and an external reliability of 0.6. Data collection required significant investment in terms of staff time and training. The method used produced indicators that achieved a high degree of acceptance from health care professionals. The reliability of data collection was high for this audit and was similar to the level seen in other successful national audits. Data collection for the indicators was feasible to collect, however, issues of time and staffing were identified as limitations to such data collection. The study has described a systematic method for developing clinical indicators for national audit. The indicators proved robust and reliable in primary and secondary care as well as long-term care settings.

Is there a need for a clinical decision rule in blunt wrist trauma?

PubMed

van den Brand, Crispijn L; van Leerdam, Roderick H; van Ufford, Jet H M E Quarles; Rhemrev, Steven J

2013-11-01

Blunt wrist trauma is a very common injury in emergency medicine. However, in contrast to other extremity trauma, there is no clinical decision rule for radiography in patients with blunt wrist trauma. The purpose of this study is to describe current practice and to assess the need and feasibility for a clinical decision rule for radiography in patients with blunt wrist trauma. All patients with blunt wrist trauma who presented to our Emergency Department (ED) during a 6-month period were included in this study. Basic demographics were analysed and the radiography ratio was determined. The radiography results were compared for different demographic groups. Current practice and the need and feasibility for a decision rule were evaluated using Stiell's checklist for clinical decision rules. A total of 1019 patients with 1032 blunt wrist injuries presented at our ED in a period of 6 months. In 91.4% of patients, radiographs were taken. In 41.6% of those radiographed, a fracture was visible on plain radiography. Fractures were most common in the paediatric and senior age groups. However, even in the lower-risk groups we observed a fracture incidence of about 20%. There is no need for a clinical decision rule for radiography in patients with blunt wrist trauma because the fracture ratio is high. Neither does it seem feasible to develop a highly sensitive and efficient decision rule. Therefore, the authors recommend radiography in all patients with blunt wrist trauma presenting to the ED. Copyright © 2013 Elsevier Ltd. All rights reserved.

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

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

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

2016-01-21

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. 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. 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. ISRCTN 49875385; Pre-results. 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/

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.

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

Clinical feasibility of brain-computer interface based on steady-state visual evoked potential in patients with locked-in syndrome: Case studies.

PubMed

Hwang, Han-Jeong; Han, Chang-Hee; Lim, Jeong-Hwan; Kim, Yong-Wook; Choi, Soo-In; An, Kwang-Ok; Lee, Jun-Hak; Cha, Ho-Seung; Hyun Kim, Seung; Im, Chang-Hwan

2017-03-01

Although the feasibility of brain-computer interface (BCI) systems based on steady-state visual evoked potential (SSVEP) has been extensively investigated, only a few studies have evaluated its clinical feasibility in patients with locked-in syndrome (LIS), who are the main targets of BCI technology. The main objective of this case report was to share our experiences of SSVEP-based BCI experiments involving five patients with LIS, thereby providing researchers with useful information that can potentially help them to design BCI experiments for patients with LIS. In our experiments, a four-class online SSVEP-based BCI system was implemented and applied to four of five patients repeatedly on multiple days to investigate its test-retest reliability. In the last experiments with two of the four patients, the practical usability of our BCI system was tested using a questionnaire survey. All five patients showed clear and distinct SSVEP responses at all four fundamental stimulation frequencies (6, 6.66, 7.5, 10 Hz), and responses at harmonic frequencies were also observed in three patients. Mean classification accuracy was 76.99% (chance level = 25%). The test-retest reliability experiments demonstrated stable performance of our BCI system over different days even when the initial experimental settings (e.g., electrode configuration, fixation time, visual angle) used in the first experiment were used without significant modifications. Our results suggest that SSVEP-based BCI paradigms might be successfully used to implement clinically feasible BCI systems for severely paralyzed patients. © 2016 Society for Psychophysiological Research.

Feasibility of Augmented Reality in Clinical Simulations: Using Google Glass With Manikins.

PubMed

Chaballout, Basil; Molloy, Margory; Vaughn, Jacqueline; Brisson Iii, Raymond; Shaw, Ryan

2016-03-07

Studies show that students who use fidelity-based simulation technology perform better and have higher retention rates than peers who learn in traditional paper-based training. Augmented reality is increasingly being used as a teaching and learning tool in a continual effort to make simulations more realistic for students. The aim of this project was to assess the feasibility and acceptability of using augmented reality via Google Glass during clinical simulation scenarios for training health science students. Students performed a clinical simulation while watching a video through Google Glass of a patient actor simulating respiratory distress. Following participation in the scenarios students completed two surveys and were questioned if they would recommend continued use of this technology in clinical simulation experiences. We were able to have students watch a video in their field of vision of a patient who mimicked the simulated manikin. Students were overall positive about the implications for being able to view a patient during the simulations, and most students recommended using the technology in the future. Overall, students reported perceived realism with augmented reality using Google Glass. However, there were technical and usability challenges with the device. As newer portable and consumer-focused technologies become available, augmented reality is increasingly being used as a teaching and learning tool to make clinical simulations more realistic for health science students. We found Google Glass feasible and acceptable as a tool for augmented reality in clinical simulations.

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 ).

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

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

PubMed

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

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. 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. 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. 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.

Computerized patient identification for the EMBRACA clinical trial using real-time data from the PRAEGNANT network for metastatic breast cancer patients.

PubMed

Hein, Alexander; Gass, Paul; Walter, Christina Barbara; Taran, Florin-Andrei; Hartkopf, Andreas; Overkamp, Friedrich; Kolberg, Hans-Christian; Hadji, Peyman; Tesch, Hans; Ettl, Johannes; Wuerstlein, Rachel; Lounsbury, Debra; Lux, Michael P; Lüftner, Diana; Wallwiener, Markus; Müller, Volkmar; Belleville, Erik; Janni, Wolfgang; Fehm, Tanja N; Wallwiener, Diethelm; Ganslandt, Thomas; Ruebner, Matthias; Beckmann, Matthias W; Schneeweiss, Andreas; Fasching, Peter A; Brucker, Sara Y

2016-07-01

As breast cancer is a diverse disease, clinical trials are becoming increasingly diversified and are consequently being conducted in very small subgroups of patients, making study recruitment increasingly difficult. The aim of this study was to assess the use of data from a remote data entry system that serves a large national registry for metastatic breast cancer. The PRAEGNANT network is a real-time registry with an integrated biomaterials bank that was designed as a scientific study and as a means of identifying patients who are eligible for clinical trials, based on clinical and molecular information. Here, we report on the automated use of the clinical data documented to identify patients for a clinical trial (EMBRACA) for patients with metastatic breast cancer. The patients' charts were assessed by two independent physicians involved in the clinical trial and also by a computer program that tested patients for eligibility using a structured query language script. In all, 326 patients from two study sites in the PRAEGNANT network were included in the analysis. Using expert assessment, 120 of the 326 patients (37 %) appeared to be eligible for inclusion in the EMBRACA study; with the computer algorithm assessment, a total of 129 appeared to be eligible. The sensitivity of the computer algorithm was 0.87 and its specificity was 0.88. Using computer-based identification of patients for clinical trials appears feasible. With the instrument's high specificity, its application in a large cohort of patients appears to be feasible, and the workload for reassessing the patients is limited.

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.

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

PubMed

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

2017-12-01

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. 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. Transoral thyroidectomy was successfully performed at both institutions with robotic and endoscopic techniques. All vital structures were identified and preserved. 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.

Implementing Routine Suicide Risk Screening for Psychiatric Outpatients With Serious Mental Disorders: I. Qualitative Results

PubMed Central

Lang, Michelle; Uttaro, Thomas; Caine, Eric; Carpinello, Sharon; Felton, Chip

2010-01-01

The objective of this study was to acquire process information, clinician and client feedback during implementation of a routine suicide risk screening program for outpatients with serious mental disorders. We studied implementation of a suicide-screening tool in a large public mental health outpatient facility in New York City. Most clinical staff who provided an opinion indicated screening was useful, feasible and helpful; most clients did not mind screening. Facilitators to program implementation included administrative support and ease of use. Barriers included consent, misperceptions, and concerns regarding potential liability. It is feasible to implement a suicide-screening tool in a public outpatient clinic. However, even experienced clinicians harbor unfounded myths. Effective large scale use will require vigorous training and oversight. PMID:19363752

Motivational interviewing to improve postabortion contraceptive uptake by young women: development and feasibility of a counseling intervention.

PubMed

Whitaker, A K; Quinn, M T; Martins, S L; Tomlinson, A N; Woodhams, E J; Gilliam, M

2015-10-01

The objective was to develop and test a postabortal contraception counseling intervention using motivational interviewing (MI) and to determine the feasibility, impact and patient acceptability of the intervention when integrated into an urban academic abortion clinic. A single-session postabortal contraception counseling intervention for young women aged 15-24 years incorporating principles, skills and style of MI was developed. Medical and social work professionals were trained to deliver the intervention, their competency was assessed, and the intervention was integrated into the clinical setting. Feasibility was determined by assessing ability to approach and recruit participants, ability to complete the full intervention without interruption and participant satisfaction with the counseling. We approached 90% of eligible patients and 71% agreed to participate (n=20). All participants received the full counseling intervention. The median duration of the intervention was 29 min. Immediately after the intervention and at the 1-month follow-up contact, 95% and 77% of participants reported that the session was helpful, respectively. MI counseling can be tailored to the abortion setting. It is feasible to train professionals to use MI principles, skills and style and to implement an MI-based contraception counseling intervention in an urban academic abortion clinic. The sessions are acceptable to participants. The use of motivational interviewing in contraception counseling may be an appropriate and effective strategy for increasing use of contraception after abortion. This study demonstrates that this patient-centered, directive and collaborative approach can be developed into a counseling intervention that can be integrated into an abortion clinic. Copyright © 2015 Elsevier Inc. All rights reserved.

Rapid stepping test towards virtual visual objects: Feasibility and convergent validity in older adults.

PubMed

Hutzler, Yeshayahu; Korsensky, Olga; Laufer, Yocheved

2017-01-01

Rapid voluntary stepping has been recognized as an important measure of balance control. The purpose of this study was to assess the feasibility and convergent validity of a Rapid Stepping Test protocol utilizing a virtual reality SeeMeTM system (VR-RST) in elderly ambulatory and independent individuals living in a community residential home. Associations between step execution times determined by the system and the Activities-specific Balance Confidence (ABC) Questionnaire, and clinical measures of balance performance in the MiniBESTest and Timed Up and Go (TUG) test, were established in 60 participants (mean age 88.2 ± 5.0 years). All participants completed the study. The correlations of the ABC questionnaire and the clinical tests with VR-RST forward and backward stepping were moderate (ρ rage 0.42-0.52), and weak to moderate with sideward stepping (ρ rage 0.32-0.52). Moderate to strong correlations were found across stepping directions (ρ rage 0.45-0.87). Findings support the test's feasibility and validity and confirm the utility of the VR-RST as an assessment tool in an elderly population.

Blood pressure self-monitoring in pregnancy: examining feasibility in a prospective cohort study.

PubMed

Tucker, Katherine L; Taylor, Kathryn S; Crawford, Carole; Hodgkinson, James A; Bankhead, Clare; Carver, Tricia; Ewers, Elizabeth; Glogowska, Margaret; Greenfield, Sheila M; Ingram, Lucy; Hinton, Lisa; Khan, Khalid S; Locock, Louise; Mackillop, Lucy; McCourt, Christine; Pirie, Alexander M; Stevens, Richard; McManus, Richard J

2017-12-28

Raised blood pressure (BP) affects approximately 10% of pregnancies worldwide, and a high proportion of affected women develop pre-eclampsia. This study aimed to evaluate the feasibility of self-monitoring of BP in pregnancy in women at higher risk of pre-eclampsia. This prospective cohort study of self-monitoring BP in pregnancy was carried out in two hospital trusts in Birmingham and Oxford and thirteen primary care practices in Oxfordshire. Eligible women were those defined by the UK National Institute for Health and Care Excellence (NICE) guidelines as at higher risk of pre-eclampsia. A total of 201 participants were recruited between 12 and 16 weeks of pregnancy and were asked to take two BP readings twice daily three times a week through their pregnancy. Primary outcomes were recruitment, retention and persistence of self-monitoring. Study recruitment and retention were analysed with descriptive statistics. Survival analysis was used to evaluate the persistence of self-monitoring and the performance of self-monitoring in the early detection of gestational hypertension, compared to clinic BP monitoring. Secondary outcomes were the mean clinic and self-monitored BP readings and the performance of self-monitoring in the detection of gestational hypertension and pre-eclampsia compared to clinic BP. Of 201 women recruited, 161 (80%) remained in the study at 36 weeks or to the end of their pregnancy, 162 (81%) provided any home readings suitable for analysis, 148 (74%) continued to self-monitor at 20 weeks and 107 (66%) at 36 weeks. Self-monitored readings were similar in value to contemporaneous matched clinic readings for both systolic and diastolic BP. Of the 23 who developed gestational hypertension or pre-eclampsia and self-monitored, 9 (39%) had a raised home BP prior to a raised clinic BP. Self-monitoring of BP in pregnancy is feasible and has potential to be useful in the early detection of gestational hypertensive disorders but maintaining self-monitoring throughout pregnancy requires support and probably enhanced training.

Experiences in Rural Mental Health. V: Creating Alternatives to Clinical Care.

ERIC Educational Resources Information Center

Hollister, William G.; And Others

Based on a North Carolina feasibility study (1967-73) which focused on development of a pattern for providing comprehensive mental health services to rural people, this guide deals with the process of creating alternatives to clinical care in Vance and Franklin counties. Specifically, this booklet details the chronological development of the…

76 FR 70150 - Draft Guidance for Industry and Food and Drug Administration Staff; Investigational Device...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-11-10

... proof of principle and initial clinical safety data before the device design is finalized. This draft... to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm.... Early feasibility studies allow for early clinical evaluation of devices to provide proof of principle...

Development of a Domain Analysis Model for Electronic Institutional Review Board Systems: A Feasibility Study

ERIC Educational Resources Information Center

He, Shan

2013-01-01

Clinical research plays a vital role in producing knowledge valuable for understanding human disease and improving healthcare quality. Human subject protection is an obligation essential to the clinical research endeavor, much of which is governed by federal regulations and rules. Institutional Review Boards (IRBs) are responsible for overseeing…

Pilot Clinical Application of an Adaptive Robotic System for Young Children with Autism

ERIC Educational Resources Information Center

Bekele, Esubalew; Crittendon, Julie A.; Swanson, Amy; Sarkar, Nilanjan; Warren, Zachary E.

2014-01-01

It has been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorders. This pilot feasibility study evaluated the application of a novel adaptive robot-mediated system capable of both administering and automatically adjusting joint attention prompts to a small…

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.…

Assessment of functional MR imaging in neurosurgical planning.

PubMed

Lee, C C; Ward, H A; Sharbrough, F W; Meyer, F B; Marsh, W R; Raffel, C; So, E L; Cascino, G D; Shin, C; Xu, Y; Riederer, S J; Jack, C R

1999-09-01

Presurgical sensorimotor mapping with functional MR imaging is gaining acceptance in clinical practice; however, to our knowledge, its therapeutic efficacy has not been assessed in a sizable group of patients. Our goal was to identify how preoperative sensorimotor functional studies were used to guide the treatment of neuro-oncologic and epilepsy surgery patients. We retrospectively reviewed the medical records of 46 patients who had undergone preoperative sensorimotor functional MR imaging to document how often and in what ways the imaging studies had influenced their management. Clinical management decisions were grouped into three categories: for assessing the feasibility of surgical resection, for surgical planning, and for selecting patients for invasive functional mapping procedures. Functional MR imaging studies successfully identified the functional central sulcus ipsilateral to the abnormality in 32 of the 46 patients, and these 32 patients are the focus of this report. In epilepsy surgery candidates, the functional MR imaging results were used to determine in part the feasibility of a proposed surgical resection in 70% of patients, to aid in surgical planning in 43%, and to select patients for invasive surgical functional mapping in 52%. In tumor patients, the functional MR imaging results were used to determine in part the feasibility of surgical resection in 55%, to aid in surgical planning in 22%, and to select patients for invasive surgical functional mapping in 78%. Overall, functional MR imaging studies were used in one or more of the three clinical decision-making categories in 89% of tumor patients and 91% of epilepsy surgery patients. Preoperative functional MR imaging is useful to clinicians at three key stages in the preoperative clinical management paradigm of a substantial percentage of patients who are being considered for resective tumor or epilepsy surgery.

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.

Development of Pain Endpoint Models for Use in Prostate Cancer Clinical Trials and Drug Approval

DTIC Science & Technology

2017-10-01

publication delineating key methodological components of pain studies in prostate cancer. KEYWORDS Pain, metastatic castrate resistant prostate cancer...pain palliation and pain progression in prostate cancer clinical trials that are feasible, methodologically rigorous, and meet regulatory...requirements for drug approval and labeling. The primary aim of this award is to conduct an observational longitudinal study in men with castrate-resistant

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.

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.

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

PubMed

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

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

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

PubMed Central

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

2017-01-01

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

Routine clinical application of virtual reality in abdominal surgery.

PubMed

Sampogna, Gianluca; Pugliese, Raffaele; Elli, Marco; Vanzulli, Angelo; Forgione, Antonello

2017-06-01

The advantages of 3D reconstruction, immersive virtual reality (VR) and 3D printing in abdominal surgery have been enunciated for many years, but still today their application in routine clinical practice is almost nil. We investigate their feasibility, user appreciation and clinical impact. Fifteen patients undergoing pancreatic, hepatic or renal surgery were studied realizing a 3D reconstruction of target anatomy. Then, an immersive VR environment was developed to import 3D models, and some details of the 3D scene were printed. All the phases of our workflow employed open-source software and low-cost hardware, easily implementable by other surgical services. A qualitative evaluation of the three approaches was performed by 20 surgeons, who filled in a specific questionnaire regarding a clinical case for each organ considered. Preoperative surgical planning and intraoperative guidance was feasible for all patients included in the study. The vast majority of surgeons interviewed scored their quality and usefulness as very good. Despite extra time, costs and efforts necessary to implement these systems, the benefits shown by the analysis of questionnaires recommend to invest more resources to train physicians to adopt these technologies routinely, even if further and larger studies are still mandatory.

The European Society for Medical Oncology 'Magnitude of Clinical Benefit Scale' field-tested in infrequent tumour entities: an extended analysis of its feasibility at the Medical University of Vienna.

PubMed

Kiesewetter, Barbara; Raderer, Markus; Prager, Gerald W; Fuereder, Thorsten; Marosi, Christine; Preusser, Matthias; Krainer, Michael; Locker, Gottfried J; Brodowicz, Thomas; Zielinski, Christoph C

2017-01-01

The European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a new tool to quantify the clinical benefit that may be anticipated from a novel anticancer treatment. We present here an analysis on the feasibility of the ESMO-MCBS in less frequent tumour entities. This study evaluates the practicability of the ESMO-MCBS for metastatic neuroendocrine tumours (NETs), soft tissue sarcomas, glioblastoma, thyroid cancer, pancreatic cancer, head/neck cancer, urothelial cancer and ovarian cancer at the Medical University Vienna. A three-step approach including data acquisition, assessment of ESMO-MCBS scores and evaluation of results with a focus on clinical feasibility was applied. In NET and thyroid cancer, all analysed trials were very comparable in design and efficacy, and the ESMO-MCBS scores appeared to be consistent with the clinical benefit seen in practice. For pancreatic cancer, it was more difficult to compare first-line trials due to diverging populations included in the respective studies. Concerning soft tissue sarcomas, the ESMO-MCBS was applicable for gastrointestinal stromal tumours(GIST) and 'non-GIST' soft tissue sarcoma with respect to data deriving from randomised studies. However, due to the heterogeneity of the disease itself and a limited number of controlled trials, limitations are noted. In ovarian cancer, the ESMO-MCBS supported the use of bevacizumab in high-risk patients. To date, there are only limited data for glioblastoma, head/neck cancer and urothelial cancer but whenever randomised trials were available, the ESMO-MCBS rating supported clinical decisions. Interestingly, nivolumab for salvage treatment of head/neck cancer rated extremely high. The ESMO-MCBS scores supported our common treatment strategies and highlight the potential of new immunomodulatory drugs. Our results encourage further development of the ESMO-MCBS.

Validation of Mismatch Negativity and P3a for Use in Multi-Site Studies of Schizophrenia: Characterization of Demographic, Clinical, Cognitive, and Functional Correlates in COGS-2

PubMed Central

Light, Gregory A.; Swerdlow, Neal R.; Thomas, Michael L.; Calkins, Monica E.; Green, Michael F.; Greenwood, Tiffany A.; Gur, Raquel E.; Gur, Ruben C.; Lazzeroni, Laura C.; Nuechterlein, Keith H.; Pela, Marlena; Radant, Allen D.; Seidman, Larry J.; Sharp, Richard F.; Siever, Larry J.; Silverman, Jeremy M.; Sprock, Joyce; Stone, William S.; Sugar, Catherine A.; Tsuang, Debby W.; Tsuang, Ming T.; Braff, David L.; Turetsky, Bruce I.

2014-01-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP data was obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. PMID:25449710

Validation of mismatch negativity and P3a for use in multi-site studies of schizophrenia: characterization of demographic, clinical, cognitive, and functional correlates in COGS-2.

PubMed

Light, Gregory A; Swerdlow, Neal R; Thomas, Michael L; Calkins, Monica E; Green, Michael F; Greenwood, Tiffany A; Gur, Raquel E; Gur, Ruben C; Lazzeroni, Laura C; Nuechterlein, Keith H; Pela, Marlena; Radant, Allen D; Seidman, Larry J; Sharp, Richard F; Siever, Larry J; Silverman, Jeremy M; Sprock, Joyce; Stone, William S; Sugar, Catherine A; Tsuang, Debby W; Tsuang, Ming T; Braff, David L; Turetsky, Bruce I

2015-04-01

Mismatch negativity (MMN) and P3a are auditory event-related potential (ERP) components that show robust deficits in schizophrenia (SZ) patients and exhibit qualities of endophenotypes, including substantial heritability, test-retest reliability, and trait-like stability. These measures also fulfill criteria for use as cognition and function-linked biomarkers in outcome studies, but have not yet been validated for use in large-scale multi-site clinical studies. This study tested the feasibility of adding MMN and P3a to the ongoing Consortium on the Genetics of Schizophrenia (COGS) study. The extent to which demographic, clinical, cognitive, and functional characteristics contribute to variability in MMN and P3a amplitudes was also examined. Participants (HCS n=824, SZ n=966) underwent testing at 5 geographically distributed COGS laboratories. Valid ERP recordings were obtained from 91% of HCS and 91% of SZ patients. Highly significant MMN (d=0.96) and P3a (d=0.93) amplitude reductions were observed in SZ patients, comparable in magnitude to those observed in single-lab studies with no appreciable differences across laboratories. Demographic characteristics accounted for 26% and 18% of the variance in MMN and P3a amplitudes, respectively. Significant relationships were observed among demographically-adjusted MMN and P3a measures and medication status as well as several clinical, cognitive, and functional characteristics of the SZ patients. This study demonstrates that MMN and P3a ERP biomarkers can be feasibly used in multi-site clinical studies. As with many clinical tests of brain function, demographic factors contribute to MMN and P3a amplitudes and should be carefully considered in future biomarker-informed clinical studies. Published by Elsevier B.V.

Feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus™ for frail elderly: study protocol for a feasibility trial.

PubMed

Gomes, Gisele Cristine Vieira; Bacha, Jéssica Maria Ribeiro; do Socorro Simões, Maria; Lin, Sumika Mori; Viveiro, Larissa Alamino Pereira; Varise, Eliana Maria; Filho, Wilson Jacob; Pompeu, José Eduardo

2017-01-01

Frailty can be defined as a medical syndrome with multiple causes and contributors, characterized by diminished strength and endurance and reduced physiological function that increases the vulnerability to develop functional dependency and/or death. Studies have shown that the most commonly studied exercise protocol for frail older adults is the multimodal training. Interactive video games (IVGs) involve tasks in virtual environments that combine physical and cognitive demands in an attractive and challenging way. The aim of this study will be to evaluate the feasibility, safety, acceptability, and functional outcomes of playing Nintendo Wii Fit Plus TM (NWFP) for frail older adults. The study is a randomized controlled, parallel group, feasibility trial. Participants will be randomly assigned to the experimental group (EG) and control group (CG). The EG will participate in 14 training sessions, each lasting 50 min, twice a week. In each training session, the participants will play five games, with three attempts at each game. The first attempt will be performed with the assistance of a physical therapist to correct the movements and posture of the patients and subsequent attempts will be performed independently. Scores achieved in the games will be recorded. The participants will be evaluated by a blinded physical therapist at three moments: before and after intervention and 30 days after the end of the intervention (follow-up). We will assess the feasibility, acceptability, safety, and clinical outcomes (postural control, gait, cognition, quality of life, mood, and fear of falling). Due to the deficiencies in multiple systems, studies have shown that multimodal interventions including motor-cognitive stimulation can improve the mobility of frail elderly adults. IVGs, among them the NWFP, are considered as a multimodal motor-cognitive intervention that can potentially improve motor and cognitive functions in the frail elderly. However, there is still no evidence in the literature that proves the feasibility, safety, acceptability, and functional outcomes of this intervention in frail elderly individuals. Brazilian Registry of Clinical Trials (RBR-823rst). World Health Organization Trial Registration Data Set (Additional file 1).

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

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/.

Active Treatment for Idiopathic Adolescent Scoliosis (ACTIvATeS): a feasibility study.

PubMed

Williams, Mark A; Heine, Peter J; Williamson, Esther M; Toye, Francine; Dritsaki, Melina; Petrou, Stavros; Crossman, Richard; Lall, Ranjit; Barker, Karen L; Fairbank, Jeremy; Harding, Ian; Gardner, Adrian; Slowther, Anne-Marie; Coulson, Neil; Lamb, Sarah E

2015-07-01

The feasibility of conducting a definitive randomised controlled trial (RCT) evaluating the clinical effectiveness and cost-effectiveness of scoliosis-specific exercises (SSEs) for adolescent idiopathic scoliosis (AIS) is uncertain. The aim of this study was to assess the feasibility of conducting a large, multicentre trial of SSE treatment for patients with AIS, in comparison with standard care, and to refine elements of the study design. The objectives were to (1) update a systematic review of controlled trials evaluating the efficacy of SSE in AIS; (2) survey UK orthopaedic surgeons and physiotherapists to determine current practice, patient populations and equipoise; (3) randomise 50 adolescents to a feasibility trial of either usual care or SSE interventions across a range of sites; (4) develop, document and assess acceptability and adherence of interventions; (5) assess and describe training requirements of physiotherapists; and (6) gain user input in all relevant stages of treatment and protocol design. Multicomponent feasibility study including UK clinician survey, systematic literature review and a randomised feasibility trial. The randomised feasibility study involved four secondary care NHS trusts providing specialist care for patients with AIS. The randomised feasibility study recruited people aged 10-16 years with mild AIS (Cobb angle of < 50°). The randomised study allocated participants to standard practice of advice and education or a physiotherapy SSE programme supported by a home exercise plan. Our choice of intervention was informed by a systematic review of exercise interventions for AIS. The main outcome was feasibility of recruitment to the randomised study. Other elements were to inform choice of outcomes for a definitive trial and included curve severity, quality of life, requirement for surgery/brace, adverse events, psychological symptoms, costs and health utilities. A UK survey of orthopaedic consultants and physiotherapists indicated a wide variation in current provision of exercise therapy through physiotherapy services. It also found that clinicians from at least 15 centres would be willing to have their patients involved in a full study. A systematic review update found five new studies that were generally of low quality but showed some promise of effectiveness of SSE. The randomised study recruited 58 patients from four NHS trusts over 11 months and exceeded the pre-specified target recruitment rate of 1.4 participants per centre per month, with acceptable 6-month follow-up (currently 73%). Adherence to treatment was variable (56% of participants completed treatment offered). The qualitative study found the exercise programme to be highly acceptable. We learnt important lessons from patient and public involvement during the study in terms of study and intervention presentation, as well as practical elements such as scheduling of intervention sessions. A definitive RCT evaluating clinical effectiveness and cost-effectiveness of SSE for idiopathic scoliosis is warranted and feasible. Such a RCT is a priority for future work in the area. There is a sufficiently large patient base, combined with willingness to be randomised within specialist UK centres. Interventions developed during the feasibility study were acceptable to patients, families and physiotherapists and can be given within the affordability envelope of current levels of physiotherapy commissioning. Current Controlled Trials ISRCTN90480705. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 55. See the NIHR Journals Library website for further project information.

The reliability of workplace-based assessment in postgraduate medical education and training: a national evaluation in general practice in the United Kingdom.

PubMed

Murphy, Douglas J; Bruce, David A; Mercer, Stewart W; Eva, Kevin W

2009-05-01

To investigate the reliability and feasibility of six potential workplace-based assessment methods in general practice training: criterion audit, multi-source feedback from clinical and non-clinical colleagues, patient feedback (the CARE Measure), referral letters, significant event analysis, and video analysis of consultations. Performance of GP registrars (trainees) was evaluated with each tool to assess the reliabilities of the tools and feasibility, given raters and number of assessments needed. Participant experience of process determined by questionnaire. 171 GP registrars and their trainers, drawn from nine deaneries (representing all four countries in the UK), participated. The ability of each tool to differentiate between doctors (reliability) was assessed using generalisability theory. Decision studies were then conducted to determine the number of observations required to achieve an acceptably high reliability for "high-stakes assessment" using each instrument. Finally, descriptive statistics were used to summarise participants' ratings of their experience using these tools. Multi-source feedback from colleagues and patient feedback on consultations emerged as the two methods most likely to offer a reliable and feasible opinion of workplace performance. Reliability co-efficients of 0.8 were attainable with 41 CARE Measure patient questionnaires and six clinical and/or five non-clinical colleagues per doctor when assessed on two occasions. For the other four methods tested, 10 or more assessors were required per doctor in order to achieve a reliable assessment, making the feasibility of their use in high-stakes assessment extremely low. Participant feedback did not raise any major concerns regarding the acceptability, feasibility, or educational impact of the tools. The combination of patient and colleague views of doctors' performance, coupled with reliable competence measures, may offer a suitable evidence-base on which to monitor progress and completion of doctors' training in general practice.

MOON-test - determination of motor performance in the pediatric oncology.

PubMed

Götte, M; Kesting, S; Albrecht, C; Worth, A; Bös, K; Boos, J

2013-05-01

Pediatric cancer patients suffer from various negative consequences due to the disease, the medical therapy and the inactivity during the intensive treatment. Only few studies have systematically identified the adverse effects of cancer on motor performance in childhood. To determine the motor performance of pediatric cancer patients, a motor performance test was developed which is applicable for this specific patient group. Eight test items with reference values for healthy children were merged to the MOON-test (test for motor performance in the oncology). MOON was tested for feasibility and acceptance in 33 patients aged 4-18 years. Feasibility was confirmed for children with different types of cancer (hematological malignancies and solid tumors) and with amputation, endoprosthesis, during aplasia as well as reduced general condition. Furthermore the patients showed a broad acceptance. Based on the study findings, the use of MOON-test as a standardized motor performance diagnostic tool in clinical routine of oncological acute clinics as well as rehabilitation clinics can be recommended.· © Georg Thieme Verlag KG Stuttgart · New York.

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.

[Study of correlation dimension on EEG].

PubMed

Yang, Hao; Fang, Liang; He, Wei

2004-02-01

The study of non-linear EEG is of great significance in clinical practice and research work. This paper has gone into the feasibility of calculating the correlation dimension and has developed some subjects with the characters of correlation dimension and the difference under four conditions: (1) passive eyes closed(PEC); (2) mental arithmetic with eyes closed(MAEC); (3) passive eyes open(PEO); (4) mental reasoning with eyes open (MRED). The results show it is feasible and meaningful to calculate correlation dimension and the correlation dimension can reflect the regular patterns of mental activity.

Adapting the concept of explanatory models of illness to the study of youth violence.

PubMed

Biering, Páll

2007-07-01

This study explores the feasibility of adapting Kleinman's concept of explanatory models of illness to the study of youth violence and is conducted within the hermeneutic tradition. Data were collected by interviewing 11 violent adolescents, their parents, and their caregivers. Four types of explanatory models representing the adolescent girls', the adolescent boys', the caregivers', and the parents' understanding of youth violence are found; they correspond sufficiently to Kleinman's concept and establish the feasibility of adapting it to the study of youth violence. The developmental nature of the parents' and adolescents' models makes it feasible to study them by means of hermeneutic methodology. There are some clinically significant discrepancies between the caregivers' and the clients' explanatory models; identifying such discrepancies is an essential step in the process of breaking down barriers to therapeutic communications. Violent adolescents should be encouraged to define their own explanatory models of violence through dialogue with their caregivers.

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

PubMed

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

2016-03-01

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. To assess the feasibility of using online software to collect quality patient information. 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. 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. 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.

Large-Scale Wearable Sensor Deployment in Parkinson's Patients: The Parkinson@Home Study Protocol.

PubMed

Silva de Lima, Ana Lígia; Hahn, Tim; de Vries, Nienke M; Cohen, Eli; Bataille, Lauren; Little, Max A; Baldus, Heribert; Bloem, Bastiaan R; Faber, Marjan J

2016-08-26

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. 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. 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. 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. 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. ClinicalTrials.gov NCT02474329; https://clinicaltrials.gov/ct2/show/NCT02474329 (Archived at http://www.webcitation.org/6joEc5P1v).

Psychoeducation in bipolar disorder with a SIMPLe smartphone application: Feasibility, acceptability and satisfaction.

PubMed

Hidalgo-Mazzei, Diego; Mateu, Ainoa; Reinares, María; Murru, Andrea; Del Mar Bonnín, Caterina; Varo, Cristina; Valentí, Marc; Undurraga, Juan; Strejilevich, Sergio; Sánchez-Moreno, José; Vieta, Eduard; Colom, Francesc

2016-08-01

During the last fifteen years, the possibility of delivering psychoeducation programs through Internet-based platforms have been explored. Studies evaluating those programs have shown good to acceptable retention rates. In this context, we developed a smartphone application (SIMPLe) collecting information about mood symptoms and offering personalized psychoeducation messages. The main aims of this study were to evaluate the feasibility, acceptability and satisfaction of the smartphone application. The study was conducted from March to August 2015. Participation in the study was proposed to a consecutive sample of adult patients attending an outpatient mental health clinic. Sociodemographic data, clinical and functional assessments alongside smartphone ownership and uses were collected at baseline and at 3 months' follow-up. A 5 item Likert-scale satisfaction questionnaire was also employed. 51 participants were initially enrolled in the study, 36 (74%) remained actively using the application after 3 months. The whole sample interacted with the application a mean of 77 days (SD=26.2). During these days they completed 88% of the daily tests. Over 86% of the participants agreed that the experience using the application was satisfactory. The diversity of smartphones operating systems led to a moderate, although representative, sample number. Additionally, the subjective data reporting, narrow time frame of use and stability of the patients could have affected the results. The results confirm that this particular intervention is feasible and represent a satisfactory and acceptable instrument for the self-management of bipolar disorder as an add-on to the usual treatment but future clinical trials must still probe its efficacy. Copyright © 2016 Elsevier B.V. All rights reserved.

Symptoms and Needs of Head and Neck Cancer Patients at Diagnosis of Incurability - Prevalences, Clinical Implications, and Feasibility of a Prospective Longitudinal Multicenter Cohort Study.

PubMed

Alt-Epping, Bernd; Seidel, Wiebke; Vogt, Jeannette; Mehnert, Anja; Thomas, Michael; van Oorschot, Birgitt; Wolff, Hendrik; Schliephake, Henning; Canis, Martin; Dröge, Leif H; Nauck, Friedemann; Lordick, Florian

2016-01-01

Little is known about the physical symptoms and psychosocial burden of patients at the time of diagnosis of an incurable situation, although cancer treatment guidelines demand early assessment and integration of palliative care concepts, beginning from the diagnosis of incurability. Therefore, we initiated a prospective longitudinal multicenter cohort study assessing the symptoms and needs of patients suffering from incurable cancer (various entities), from the time of diagnosing incurability (i.e., before palliative anticancer treatment was initiated) and in 3-monthly intervals thereafter, by using validated self-reporting tools. Here, we focus on patients with head and neck cancer and present preliminary results on symptoms and need prevalences, on clinical implications, and on the feasibility of a methodologically complex assessment procedure in a particularly vulnerable study population. 22 patients completed the first visit. The Eastern Cooperative Oncology Group (ECOG) performance scores and most physical symptoms and psychosocial items varied between the extremes, from a virtually uncompromised condition to extremely perceived symptoms and needs. If intense face-to-face study support was provided, the study concept proved to be feasible, despite the complexity of assessment, problems in interdisciplinary and patient communication, comorbidities, and early death from complications. The striking variability in the perceived symptom and need intensities requires a highly individualized approach. For clinical purposes, a less complex screening procedure would be desirable, in order to enable a routine, early and comprehensive support, including palliative care services. © 2016 S. Karger GmbH, Freiburg.

Using an internet intervention to support self-management of low back pain in primary care: findings from a randomised controlled feasibility trial (SupportBack)

PubMed Central

Geraghty, Adam W A; Stanford, Rosie; Stuart, Beth; Little, Paul; Roberts, Lisa C; Foster, Nadine E; Hill, Jonathan C; Hay, Elaine M; Turner, David; Malakan, Wansida; Leigh, Linda; Yardley, Lucy

2018-01-01

Objective To determine the feasibility of a randomised controlled trial of an internet intervention for low back pain (LBP) using three arms: (1) usual care, (2) usual care plus an internet intervention or (3) usual care plus an internet intervention with additional physiotherapist telephone support. Design and setting A three-armed randomised controlled feasibility trial conducted in 12 general practices in England. Participants Primary care patients aged over 18 years, with current LBP, access to the internet and without indicators of serious spinal pathology or systemic illness. Interventions The ‘SupportBack’ internet intervention delivers a 6-week, tailored programme, focused on graded goal setting, self-monitoring and provision of tailored feedback to encourage physical activity. Additional physiotherapist telephone support consisted of three brief telephone calls over a 4-week period, to address any concerns and provide reassurance. Outcomes The primary outcomes were the feasibility of the trial design including recruitment, adherence and retention at follow-up. Secondary descriptive and exploratory analyses were conducted on clinical outcomes including LBP-related disability at 3 months follow-up. Results Primary outcomes: 87 patients with LBP were recruited (target 60–90) over 6 months, and there were 3 withdrawals. Adherence to the intervention was higher in the physiotherapist-supported arm, compared with the stand-alone internet intervention. Trial physiotherapists adhered to the support protocol. Overall follow-up rate on key clinical outcomes at 3 months follow-up was 84%. Conclusions This study demonstrated the feasibility of a future definitive randomised controlled trial to determine the clinical and cost-effectiveness of the SupportBack intervention in primary care patients with LBP. Trial registration number ISRCTN31034004; Results. PMID:29525768

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

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

Analysis of Existing Guidelines for the Systematic Planning Process of Clinical Registries.

PubMed

Löpprich, Martin; Knaup, Petra

2016-01-01

Clinical registries are a powerful method to observe the clinical practice and natural disease history. In contrast to clinical trials, where guidelines and standardized methods exist and are mandatory, only a few initiatives have published methodological guidelines for clinical registries. The objective of this paper was to review these guidelines and systematically assess their completeness, usability and feasibility according to a SWOT analysis. The results show that each guideline has its own strengths and weaknesses. While one supports the systematic planning process, the other discusses clinical registries in great detail. However, the feasibility was mostly limited and the special requirements of clinical registries, their flexible, expandable and adaptable technological structure was not addressed consistently.

Caregiver person-centeredness and behavioral symptoms during mealtime interactions: development and feasibility of a coding scheme.

PubMed

Gilmore-Bykovskyi, Andrea L

2015-01-01

Mealtime behavioral symptoms are distressing and frequently interrupt eating for the individual experiencing them and others in the environment. A computer-assisted coding scheme was developed to measure caregiver person-centeredness and behavioral symptoms for nursing home residents with dementia during mealtime interactions. The purpose of this pilot study was to determine the feasibility, ease of use, and inter-observer reliability of the coding scheme, and to explore the clinical utility of the coding scheme. Trained observers coded 22 observations. Data collection procedures were acceptable to participants. Overall, the coding scheme proved to be feasible, easy to execute and yielded good to very good inter-observer agreement following observer re-training. The coding scheme captured clinically relevant, modifiable antecedents to mealtime behavioral symptoms, but would be enhanced by the inclusion of measures for resident engagement and consolidation of items for measuring caregiver person-centeredness that co-occurred and were difficult for observers to distinguish. Published by Elsevier Inc.

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design.

PubMed

Mitchiguian Hotta, Livia; Cardinalli Adler, Ubiratan; de Toledo Cesar, Amarilys; Martinez, Edson Zangiacomi; Demarzo, Marcelo Marcos Piva

2018-05-01

 Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.  The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical-pharmaceutical homeopathic protocol ( Organon.modus ) on perennial asthma in adolescents.  Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. a secondary care medical specialist centre. continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.  Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 ( p  = 0.18); median number of days of fenoterol use per patient: 3 versus 5 ( p  = 0.41); visits to an emergency room: 1 versus 6 ( p  = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% ( p  = 0.05). Few Adverse Events were reported.  This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical-pharmaceutical homeopathic protocol.  RBR-6XTS8Z. The Faculty of Homeopathy.

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.

77 FR 65567 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-29

... for Scientific Review Special Emphasis Panel; PA-12-139: Pilot and Feasibility Clinical Research Studies in Digestive Diseases and Nutrition. Date: November 29, 2012. Time: 2:00 p.m. to 4:00 p.m. Agenda... Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333, 93.337, 93...

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

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

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.

Mesenchymal Stem Cell-Based Therapy for Kidney Disease: A Review of Clinical Evidence

PubMed Central

2016-01-01

Mesenchymal stem cells form a population of self-renewing, multipotent cells that can be isolated from several tissues. Multiple preclinical studies have demonstrated that the administration of exogenous MSC could prevent renal injury and could promote renal recovery through a series of complex mechanisms, in particular via immunomodulation of the immune system and release of paracrine factors and microvesicles. Due to their therapeutic potentials, MSC are being evaluated as a possible player in treatment of human kidney disease, and an increasing number of clinical trials to assess the safety, feasibility, and efficacy of MSC-based therapy in various kidney diseases have been proposed. In the present review, we will summarize the current knowledge on MSC infusion to treat acute kidney injury, chronic kidney disease, diabetic nephropathy, focal segmental glomerulosclerosis, systemic lupus erythematosus, and kidney transplantation. The data obtained from these clinical trials will provide further insight into safety, feasibility, and efficacy of MSC-based therapy in renal pathologies and allow the design of consensus protocol for clinical purpose. PMID:27721835

Development and evaluation of a holistic surgical head and neck cancer post-treatment follow-up clinic using touchscreen technology-Feasibility study.

PubMed

Semple, C J; Lannon, D; Qudairat, E; McCaughan, E; McCormac, R

2018-03-01

The efficacy of traditional follow-up care is being challenged, as cancer survivors' supportive and psychological needs are often neither identified, nor addressed. This study's aim was to develop a holistic surgical follow-up clinic for oral and oropharyngeal cancer patients were participants completed a disease-specific health-related quality of life tool (UWQOLv4) and item prompt list (Patient Concern Inventory) on a touchscreen computer. Information generated was used to focus the consultation on patient's identified needs and concerns. By means of a prospective non-randomised, pre-test post-test design, this follow-up clinic was evaluated using the patient enablement instrument (PEI) and patient content checklist (PCC). Feasibility was explored from the patient perspective (satisfaction survey) and clinician perspective (qualitative interview). Forty-four consecutive patients were recruited. Findings demonstrating five of the eight topics (overall QOL, emotions, head and neck symptoms, side-effects of treatment, chronic non-specific) on PCC were discussed more frequently, but changes were not statistically significant. The PEI highlighted a trend towards perceived improvement in four of the six items. Using touchscreen computers to aid communication during routine follow-up was reported as both feasible and beneficial by patients and clinicians. Providing a patient-focused follow-up consultation can facilitate the identification of unmet needs, permitting timely and appropriate intervention being initiated. © 2018 John Wiley & Sons Ltd.

The Feasibility of Using Large-Scale Text Mining to Detect Adverse Childhood Experiences in a VA-Treated Population.

PubMed

Hammond, Kenric W; Ben-Ari, Alon Y; Laundry, Ryan J; Boyko, Edward J; Samore, Matthew H

2015-12-01

Free text in electronic health records resists large-scale analysis. Text records facts of interest not found in encoded data, and text mining enables their retrieval and quantification. The U.S. Department of Veterans Affairs (VA) clinical data repository affords an opportunity to apply text-mining methodology to study clinical questions in large populations. To assess the feasibility of text mining, investigation of the relationship between exposure to adverse childhood experiences (ACEs) and recorded diagnoses was conducted among all VA-treated Gulf war veterans, utilizing all progress notes recorded from 2000-2011. Text processing extracted ACE exposures recorded among 44.7 million clinical notes belonging to 243,973 veterans. The relationship of ACE exposure to adult illnesses was analyzed using logistic regression. Bias considerations were assessed. ACE score was strongly associated with suicide attempts and serious mental disorders (ORs = 1.84 to 1.97), and less so with behaviorally mediated and somatic conditions (ORs = 1.02 to 1.36) per unit. Bias adjustments did not remove persistent associations between ACE score and most illnesses. Text mining to detect ACE exposure in a large population was feasible. Analysis of the relationship between ACE score and adult health conditions yielded patterns of association consistent with prior research. Copyright © 2015 International Society for Traumatic Stress Studies.

Feasibility of mesenchymal stem cell culture expansion for a phase I clinical trial in multiple sclerosis.

PubMed

Planchon, Sarah M; Lingas, Karen T; Reese Koç, Jane; Hooper, Brittney M; Maitra, Basabi; Fox, Robert M; Imrey, Peter B; Drake, Kylie M; Aldred, Micheala A; Lazarus, Hillard M; Cohen, Jeffrey A

2018-01-01

Multiple sclerosis is an inflammatory, neurodegenerative disease of the central nervous system for which therapeutic mesenchymal stem cell transplantation is under study. Published experience of culture-expanding multiple sclerosis patients' mesenchymal stem cells for clinical trials is limited. To determine the feasibility of culture-expanding multiple sclerosis patients' mesenchymal stem cells for clinical use. In a phase I trial, autologous, bone marrow-derived mesenchymal stem cells were isolated from 25 trial participants with multiple sclerosis and eight matched controls, and culture-expanded to a target single dose of 1-2 × 10 6 cells/kg. Viability, cell product identity and sterility were assessed prior to infusion. Cytogenetic stability was assessed by single nucleotide polymorphism analysis of mesenchymal stem cells from 18 multiple sclerosis patients and five controls. One patient failed screening. Mesenchymal stem cell culture expansion was successful for 24 of 25 multiple sclerosis patients and six of eight controls. The target dose was achieved in 16-62 days, requiring two to three cell passages. Growth rate and culture success did not correlate with demographic or multiple sclerosis disease characteristics. Cytogenetic studies identified changes on one chromosome of one control (4.3%) after extended time in culture. Culture expansion of mesenchymal stem cells from multiple sclerosis patients as donors is feasible. However, culture time should be minimized for cell products designated for therapeutic administration.

Engaging patients and families to create a feasible clinical trial integrating palliative and heart failure care: results of the ENABLE CHF-PC pilot clinical trial.

PubMed

Bakitas, Marie; Dionne-Odom, J Nicholas; Pamboukian, Salpy V; Tallaj, Jose; Kvale, Elizabeth; Swetz, Keith M; Frost, Jennifer; Wells, Rachel; Azuero, Andres; Keebler, Konda; Akyar, Imatullah; Ejem, Deborah; Steinhauser, Karen; Smith, Tasha; Durant, Raegan; Kono, Alan T

2017-08-31

Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers). We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes. We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits. Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial. Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).

Outcome measures for oral health based on clinical assessments and claims data: feasibility evaluation in practice.

PubMed

Hummel, Riët; Bruers, Josef; van der Galiën, Onno; van der Sanden, Wil; van der Heijden, Geert

2017-10-05

It is well known that treatment variation exists in oral healthcare, but the consequences for oral health are unknown as the development of outcome measures is still in its infancy. The aim of this study was to identify and develop outcome measures for oral health and explore their performance using health insurance claims records and clinical data from general dental practices. The Dutch healthcare insurance company Achmea collaborated with researchers, oral health experts, and general dental practitioners (GDPs) in a proof of practice study to test the feasibility of measures in general dental practices. A literature search identified previously described outcome measures for oral healthcare. Using a structured approach, identified measures were (i) prioritized, adjusted and added to after discussion and then (ii) tested for feasibility of data collection, their face validity and discriminative validity. Data sources were claims records from Achmea, clinical records from dental practices, and prospective, pre-determined clinical assessment data obtained during routine consultations. In total eight measures (four on dental caries, one on tooth wear, two on periodontal health, one on retreatment) were identified, prioritized and tested. The retreatment measure and three measures for dental caries were found promising as data collection was feasible, they had face validity and discriminative validity. Deployment of these measures demonstrated variation in clinical practices of GDPs. Feedback of this data to GDPs led to vivid discussions on best practices and quality of care. The measure 'tooth wear' was not considered sufficiently responsive; 'changes in periodontal health score' was considered a controversial measure. The available data for the measures 'percentage of 18-year-olds with no tooth decay' and 'improvement in gingival bleeding index at reassessment' was too limited to provide accurate estimates per dental practice. The evaluated measures 'time to first restoration', 'distribution of risk categories for dental caries', 'filled-and-missing score' and 'retreatment after restoration', were considered valid and relevant measures and a proxy for oral health status. As such, they improve the transparency of oral health services delivery that can be related to oral health outcomes, and with time may serve to improve these oral health outcomes.

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

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

PubMed

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

2016-10-01

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

Cognitive behavior therapy-based psychoeducational groups for adults with ADHD and their significant others (PEGASUS): an open clinical feasibility trial.

PubMed

Hirvikoski, T; Waaler, E; Lindström, T; Bölte, S; Jokinen, J

2015-03-01

The aim of this pilot study was to investigate the feasibility and effectiveness of a new psychoeducative intervention program (PEGASUS) for adults with ADHD and their significant others in a psychiatric outpatient context. At three outpatient psychiatric clinics, adults with ADHD and their significant others took part in PEGASUS, a psychoeducational program based on theories from cognitive behavioral therapy, neuropsychology, and cross-disciplinary evidence regarding ADHD. In total, 108 adults were allocated to treatment (51 with ADHD and their 57 significant others). Feasibility was evaluated regarding suitability of the intervention at a psychiatric outpatient clinic and treatment completion. Preliminary efficacy was evaluated per protocol from baseline to post-intervention (n = 41 adults with ADHD and 40 significant others). In a feasibility analysis, the intervention was judged to be a suitable treatment option for 94.5 % of all individuals with a primary diagnosis of ADHD at an outpatient psychiatric clinic. In total, 43 out of 51 allocated individuals with ADHD (84.3 %) completed the intervention. The corresponding figures for their significant others were 42 out of 57 (73.7 %). Knowledge about ADHD increased, and both the quality of relationships and psychological well-being improved from baseline to post-intervention in all participants. The significant others reported a reduction in the subjective burden of care, such as worry and guilt. The objective burden of care (such as financial problems) did not change. The findings support the potential value of psychoeducation for adults with ADHD and their significant others. An ongoing randomized controlled trial will generate further evidence concerning the PEGASUS program.

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

Feasibility of clinical detection of cervical dysplasia using angle-resolved low coherence interferometry measurements of depth-resolved nuclear morphology.

PubMed

Ho, Derek; Drake, Tyler K; Smith-McCune, Karen K; Darragh, Teresa M; Hwang, Loris Y; Wax, Adam

2017-03-15

This study sought to establish the feasibility of using in situ depth-resolved nuclear morphology measurements for detection of cervical dysplasia. Forty enrolled patients received routine cervical colposcopy with angle-resolved low coherence interferometry (a/LCI) measurements of nuclear morphology. a/LCI scans from 63 tissue sites were compared to histopathological analysis of co-registered biopsy specimens which were classified as benign, low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL). Results were dichotomized as dysplastic (LSIL/HSIL) versus non-dysplastic and HSIL versus LSIL/benign to determine both accuracy and potential clinical utility of a/LCI nuclear morphology measurements. Analysis of a/LCI data was conducted using both traditional Mie theory based processing and a new hybrid algorithm that provides improved processing speed to ascertain the feasibility of real-time measurements. Analysis of depth-resolved nuclear morphology data revealed a/LCI was able to detect a significant increase in the nuclear diameter at the depth bin containing the basal layer of the epithelium for dysplastic versus non-dysplastic and HSIL versus LSIL/Benign biopsy sites (both p < 0.001). Both processing techniques resulted in high sensitivity and specificity (>0.80) in identifying dysplastic biopsies and HSIL. The hybrid algorithm demonstrated a threefold decrease in processing time at a slight cost in classification accuracy. The results demonstrate the feasibility of using a/LCI as an adjunctive clinical tool for detecting cervical dysplasia and guiding the identification of optimal biopsy sites. The faster speed from the hybrid algorithm offers a promising approach for real-time clinical analysis. © 2016 UICC.

Feasibility of clinical detection of cervical dysplasia using angle-resolved low coherence interferometry measurements of depth-resolved nuclear morphology

PubMed Central

Ho, Derek; Drake, Tyler K.; Smith-McCune, Karen K.; Darragh, Teresa M.; Hwang, Loris Y.; Wax, Adam

2017-01-01

This study sought to establish the feasibility of using in situ depth-resolved nuclear morphology measurements for detection of cervical dysplasia. Forty (40) enrolled patients received routine cervical colposcopy with angle-resolved low coherence interferometry (a/LCI) measurements of nuclear morphology. a/LCI scans from 63 tissue sites were compared to histopathological analysis of co-registered biopsy specimens which were classified as benign, low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL). Results were dichotomized as dysplastic (LSIL/HSIL) versus non-dysplastic and HSIL versus LSIL/benign to determine both accuracy and potential clinical utility of a/LCI nuclear morphology measurements. Analysis of a/LCI data was conducted using both traditional Mie theory based processing and a new hybrid algorithm that provides improved processing speed to ascertain the feasibility of real-time measurements. Analysis of depth-resolved nuclear morphology data revealed a/LCI was able to detect a significant increase in the nuclear diameter at the depth bin containing the basal layer of the epithelium for dysplastic versus non-dysplastic and HSIL versus LSIL/Benign biopsy sites (both p < 0.001). Both processing techniques resulted in high sensitivity and specificity (> 0.80) in identifying dysplastic biopsies and HSIL. The hybrid algorithm demonstrated a threefold decrease in processing time at a slight cost in classification accuracy. The results demonstrate the feasibility of using a/LCI as an adjunctive clinical tool for detecting cervical dysplasia and guiding the identification of optimal biopsy sites. The faster speed from the hybrid algorithm offers a promising approach for real-time clinical analysis. PMID:27883177

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

Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma.

PubMed

Sharma, Karun V; Yarmolenko, Pavel S; Celik, Haydar; Eranki, Avinash; Partanen, Ari; Smitthimedhin, Anilawan; Kim, Aerang; Oetgen, Matthew; Santos, Domiciano; Patel, Janish; Kim, Peter

2017-11-01

To evaluate clinical feasibility and safety of magnetic resonance imaging-guided high-intensity focused ultrasound (MR-HIFU) treatment of symptomatic osteoid osteoma and to compare clinical response with standard of care treatment. Nine subjects with radiologically confirmed, symptomatic osteoid osteoma were treated with MR-HIFU in an institutional review board-approved clinical trial. Treatment feasibility and safety were assessed. Clinical response was evaluated in terms of analgesic requirement, visual analog scale pain score, and sleep quality. Anesthesia, procedure, and recovery times were recorded. This MR-HIFU group was compared with a historical control group of 9 consecutive patients treated with radiofrequency ablation. Nine subjects (7 male, 2 female; 16 ± 6 years) were treated with MR-HIFU without technical difficulties or any serious adverse events. There was significant decrease in their median pain scores 4 weeks within treatment (6 vs 0, P < .01). Total pain resolution and cessation of analgesics were achieved in 8 of 9 patients after 4 weeks. In the radiofrequency ablation group, 9 patients (8 male, 1 female; 10 ± 6 years) were treated in routine clinical practice. All 9 demonstrated complete pain resolution and cessation of medications by 4 weeks with a significant decrease in median pain scores (9 vs 0, P < .001). One developed a second-degree skin burn, but there were no other adverse events. Procedure times and treatment charges were comparable between the 2 groups. This pilot study shows that MR-HIFU treatment of osteoid osteoma refractory to medical therapy is feasible and can be performed safely in pediatric patients. Clinical response is comparable with standard of care treatment but without any incisions or exposure to ionizing radiation. ClinicalTrials.govNCT02349971. Copyright © 2017 Elsevier Inc. All rights reserved.

Feasibility testing of smart tablet questionnaires compared to paper questionnaires in an amputee rehabilitation clinic.

PubMed

Payne, Michael; Janzen, Shannon; Earl, Eric; Deathe, Barry; Viana, Ricardo

2017-08-01

Capturing the variability that exists among patients attending an amputee clinic using standardized paper-based questionnaires is time-consuming and may not be practical for routine clinical use. Electronic questionnaires are a potential solution; however, the benefits are dependent on the feasibility and acceptance of this mode of data collection among patients. To determine the feasibility and patient preference/comfort in using a tablet-based questionnaire for data collection in an outpatient amputee rehabilitation clinic compared to a traditional paper-based questionnaire. Observational study. In all, 48 patients with major extremity amputations completed both tablet and paper questionnaires related to their amputation and prosthetic use. Both trials were timed; patients then completed a semi-structured questionnaire about their experience. In all, 20.5% of patients needed hands-on assistance completing the paper questionnaire compared to 20.8% for the tablet. The majority of participants (52.1%) indicated a preference for the tablet questionnaire; 64.6% of patients felt the tablet collected a more complete and accurate representation of their status and needs. In all, 70.8% of participants described themselves as comfortable using the tablet. Despite comorbidities, patients with amputations demonstrated excellent acceptance of the electronic tablet-based questionnaire. Tablet questionnaires have significant potential advantages over paper questionnaires and should be further explored. Clinical relevance A custom electronic questionnaire was found to be beneficial for routine clinic use and was well received by patients in an amputee rehabilitation clinic. Development of such questionnaires can provide an efficient mechanism to collect meaningful data that can be used for individual patient care and program quality improvement initiatives.

Data Warehouse Design from HL7 Clinical Document Architecture Schema.

PubMed

Pecoraro, Fabrizio; Luzi, Daniela; Ricci, Fabrizio L

2015-01-01

This paper proposes a semi-automatic approach to extract clinical information structured in a HL7 Clinical Document Architecture (CDA) and transform it in a data warehouse dimensional model schema. It is based on a conceptual framework published in a previous work that maps the dimensional model primitives with CDA elements. Its feasibility is demonstrated providing a case study based on the analysis of vital signs gathered during laboratory tests.

Clinical outcomes of laparoscopic-assisted synchronous bowel anastomoses for synchronous colorectal cancer: initial clinical experience

PubMed Central

Wei, Yunwei; Liu, Peng; Xu, Jun

2017-01-01

The primary aim of this study was to explore the safety and feasibility of laparoscopic-assisted synchronous bowel anastomoses (LSBA) for synchronous colorectal cancer (SCRC). All patients who underwent LSBA for SCRC were retrospectively reviewed and analyzed for clinical and pathological features, technical feasibility and short-term as well as long-term oncological outcomes. Between July 2008 and January 2012, a series of 11 consecutive SCRC patients underwent LSBA. Six patients underwent laparoscopic-assisted right hemicolectomy and anterior resection. Five patients had laparoscopic-assisted right hemicolectomy and sigmoidectomy. There were no intraoperative complications that required open conversions. Mean operation time was 233 (range, 195–285) minutes, and mean estimated blood loss was 224 (range, 100–300) mL. The postoperative course of the patients was uneventful with the mean return to oral intake was 6.9 (range 5–12) days, and mean length of hospital stay was 12.6 (range 9–17) days. All surgical wounds showed good cosmetic outcome, and the mean incision length was 4.1 (range 3.5-5.0) cm. During a median follow-up period of 76 months, no local tumor recurrences were found. LSBA is a potentially feasible and safe procedure for SCRC when performed by an experienced surgeon. Further large clinical controlled trials are warranted to confirm the findings. PMID:27821798

Australasian brachytherapy audit: results of the 'end-to-end' dosimetry pilot study.

PubMed

Haworth, Annette; Wilfert, Lisa; Butler, Duncan; Ebert, Martin A; Todd, Stephen; Bucci, Joseph; Duchesne, Gillian M; Joseph, David; Kron, Tomas

2013-08-01

We present the results of a pilot study to test the feasibility of a brachytherapy dosimetry audit. The feasibility study was conducted at seven sites from four Australian states in both public and private centres. A purpose-built cylindrical water phantom was imaged using the local imaging protocol and a treatment plan was generated to deliver 1 Gy to the central (1 of 3) thermoluminescent dosimeter (TLD) from six dwell positions. All centres completed the audit, consisting of three consecutive irradiations, within a 2-h time period, with the exception of one centre that uses a pulsed dose rate brachytherapy unit. All TLD results were within 4.5% of the predicted value, with the exception of one subset where the dwell position step size was incorrectly applied. While the limited data collected in the study demonstrated considerable heterogeneity in clinical practice, the study proved a brachytherapy dosimetry audit to be feasible. Future studies should include verification of source strength using a Standard Dosimetry Laboratory calibrated chamber, a phantom that more closely mimics the clinical situation, a more comprehensive review of safety and quality assurance (QA) procedures including source dwell time and position accuracy, and a review of patient treatment QA procedures such as applicator position verification. © 2013 The Authors. Journal of Medical Imaging and Radiation Oncology © 2013 The Royal Australian and New Zealand College of Radiologists.

Feasibility of a randomized controlled trial to evaluate the impact of decision boxes on shared decision-making processes.

PubMed

Giguere, Anik Mc; Labrecque, Michel; Légaré, France; Grad, Roland; Cauchon, Michel; Greenway, Matthew; Haynes, R Brian; Pluye, Pierre; Syed, Iqra; Banerjee, Debi; Carmichael, Pierre-Hugues; Martin, Mélanie

2015-02-25

Decision boxes (DBoxes) are two-page evidence summaries to prepare clinicians for shared decision making (SDM). We sought to assess the feasibility of a clustered Randomized Controlled Trial (RCT) to evaluate their impact. A convenience sample of clinicians (nurses, physicians and residents) from six primary healthcare clinics who received eight DBoxes and rated their interest in the topic and satisfaction. After consultations, their patients rated their involvement in decision-making processes (SDM-Q-9 instrument). We measured clinic and clinician recruitment rates, questionnaire completion rates, patient eligibility rates, and estimated the RCT needed sample size. Among the 20 family medicine clinics invited to participate in this study, four agreed to participate, giving an overall recruitment rate of 20%. Of 148 clinicians invited to the study, 93 participated (63%). Clinicians rated an interest in the topics ranging 6.4-8.2 out of 10 (with 10 highest) and a satisfaction with DBoxes of 4 or 5 out of 5 (with 5 highest) for 81% DBoxes. For the future RCT, we estimated that a sample size of 320 patients would allow detecting a 9% mean difference in the SDM-Q-9 ratings between our two arms (0.02 ICC; 0.05 significance level; 80% power). Clinicians' recruitment and questionnaire completion rates support the feasibility of the planned RCT. The level of interest of participants for the DBox topics, and their level of satisfaction with the Dboxes demonstrate the acceptability of the intervention. Processes to recruit clinics and patients should be optimized.

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.

Feasibility and impact of providing feedback to vaccinating medical clinics: evaluating a public health intervention.

PubMed

Brousseau, Nicholas; Sauvageau, Chantal; Ouakki, Manale; Audet, Diane; Kiely, Marilou; Couture, Colette; Paré, Alain; Deceuninck, Geneviève

2010-12-03

Vaccine coverage (VC) at a given age is a widely-used indicator for measuring the performance of vaccination programs. However, there is increasing data suggesting that measuring delays in administering vaccines complements the measure of VC. Providing feedback to vaccinators is recognized as an effective strategy for improving vaccine coverage, but its implementation has not been widely documented in Canada. The objective of this study was to evaluate the feasibility of providing personalized feedback to vaccinators and its impact on vaccination delays (VD). In April and May 2008, a one-hour personalized feedback session was provided to health professionals in vaccinating medical clinics in the Quebec City region. VD for vaccines administered at two and twelve months of age were presented. Data from the regional vaccination registry were analysed for participating clinics. Two 12-month periods before and after the intervention were compared, namely from April 1st, 2007 to March 31st, 2008 and from June 1st, 2008 to May 31st, 2009. Ten medical clinics out of the twelve approached (83%), representing more than 2500 vaccinated children, participated in the project. Preparing and conducting the feedback involved 20 hours of work and expenses of $1000 per clinic. Based on a delay of one month, 94% of first doses of DTaP-Polio-Hib and 77% of meningococcal vaccine doses respected the vaccination schedule both before and after the intervention. Following the feedback, respect of the vaccination schedule increased for vaccines planned at 12 months for the four clinics that had modified their vaccination practices related to multiple injections (depending on the clinic, VD decreased by 24.4%, 32.0%, 40.2% and 44.6% respectively, p < 0.001 for all comparisons). The present study shows that it is feasible to provide personalized feedback to vaccinating clinics. While it may have encouraged positive changes in practice concerning multiple injections, this intervention on its own did not impact vaccination delays of the clinics visited. It is possible that feedback integrated into other types of effective interventions and sustained over time may have more impact on VD.

77 FR 28889 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2012-05-16

... Panel; RFA Panel: System Science and Health in the Behavioral and Social Sciences. Date: June 6-7, 2012... Special Emphasis Panel; Pilot and Feasibility Clinical Research Studies in Digestive Diseases and...

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

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

PubMed

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

2017-11-03

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. Systematic review. All settings/all participants. 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). Feasibility, acceptability, impact. We searched databases MEDLINE via PubMed, Embase, Cochrane CENTRAL and Web of Science, abstracted data, explored heterogeneity, performed a random effects subgroup analysis. 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. 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. © 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.

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.

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

PubMed Central

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

2015-01-01

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

Development and Pilot-Testing of a Cognitive Behavioral Coping Skills Group Intervention for Patients with Chronic Hepatitis C.

PubMed

Evon, Donna M; Golin, Carol E; Ruffin, Rachel; Fried, Michael W

2017-06-01

Psychosocial interventions for patients with chronic hepatitis C viral (HCV) infection are needed to attenuate the impact of extrahepatic symptoms, comorbid conditions, and treatment side effects on HCV health outcomes. We adapted empirically-supported interventions for similar patient populations to develop a Cognitive Behavioral Coping Skills group intervention for HCV patients (CBCS-HCV) undergoing treatment. The objectives of this paper are to describe the research activities associated with CBCS-HCV development and pilot testing, including: (1) formative work leading to intervention development; (2) preliminary study protocol; and (3) pilot feasibility testing of the intervention and study design. Formative work included a literature review, qualitative interviews, and adaption, development, and review of study materials. A preliminary study protocol is described. We evaluate the feasibility of conducting a randomized controlled trial (RCT) of the CBCS-HCV with 12 study participants in Wave 1 testing to examine: (a) feasibility of intervention delivery; (b) patient acceptability; (c) recruitment, enrollment, retention; (d) feasibility of conducting a RCT; (d) therapist protocol fidelity; and (e) feasibility of data collection. Numerous lessons were learned. We found very high rates of data collection, participant attendance, engagement, retention and acceptability, and therapist protocol fidelity. We conclude that many aspects of the CBCS-HCV intervention and study protocol were highly feasible. The greatest challenge during this Wave 1 pilot study was efficiency of participant enrollment due to changes in standard of care treatment. These findings informed two additional waves of pilot testing to examine effect sizes and potential improvements in clinical outcomes, with results forthcoming.

Development and Application of Direct Data Capture for Monitoring Medication Compliance in Clinical Trials.

PubMed

Kim, Eun-Young

2017-10-01

The monitoring of medication compliance in clinical trials is important but labor intensive. To check medication compliance in clinical trials, a system was developed, and its technical feasibility evaluated. The system consisted of three parts: a management part (clinical trial center database and a developed program), clinical trial investigator part (monitoring), and clinical trial participant part (personal digital assistant [PDA] with a barcode scanner). The system was tested with 20 participants for 2 weeks, and compliance was evaluated. This study developed a medication compliance monitoring system that used a PDA with a barcode scanner, which sent reminder/warning messages, logged medication barcode data, and provided compliance information to investigators. Registered participants received short message service (SMS) reminder/warning messages on their PDA and sent barcode data at the dosing time. The age range of the participants was 29 to 73 years. Five participants were <50 years old and 8 were ≥65 years old. The total mean compliance rate was 82.3%. The mean compliance rate was 83.1% in participants <65 years old and 81.1% in those ≥65 years old. The system was feasible, usable, and effective, even with elderly participants, for monitoring medication compliance in clinical trials using a PDA with a barcode scanner, and may improve the quality of clinical trials.

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.

A pilot study of delivering peer health messages in an HIV clinic via mobile media.

PubMed

Winstead-Derlega, Christopher; Rafaly, Mary; Delgado, Sarah; Freeman, Jason; Cutitta, Katherine; Miles, Tony; Ingersoll, Karen; Dillingham, Rebecca

2012-01-01

This pilot study tested the feasibility and impact of using mobile media devices to present peer health messages to human immunodeficiency virus (HIV)-positive patients. A convenience sample of 30 adult patients from an outpatient HIV clinic serving a mostly rural catchment area in central Virginia volunteered for the study. Participants viewed short videos of people discussing HIV health topics on an Apple (Cupertino, CA) iPod® touch® mobile device. Pre- and post-intervention surveys assessed attitudes related to engagement in care and disease disclosure. Participants found delivery of health information by the mobile device acceptable in a clinic setting. They used the technology without difficulty. Participants reported satisfaction with and future interest in viewing such videos after using the mobile devices. The majority of participants used the device to access more videos than requested, and many reported the videos "hit home." There were no significant changes in participant perceptions about engagement in care or HIV disclosure after the intervention. This pilot study demonstrates the feasibility and acceptability of using mobile media technology to deliver peer health messages. Future research should explore how to best use mobile media to improve engagement in care and reduce perceptions of stigma.

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 =…

First-in-Human Ultrasound Molecular Imaging With a VEGFR2-Specific Ultrasound Molecular Contrast Agent (BR55) in Prostate Cancer: A Safety and Feasibility Pilot Study.

PubMed

Smeenge, Martijn; Tranquart, François; Mannaerts, Christophe K; de Reijke, Theo M; van de Vijver, Marc J; Laguna, M Pilar; Pochon, Sibylle; de la Rosette, Jean J M C H; Wijkstra, Hessel

2017-07-01

BR55, a vascular endothelial growth factor receptor 2 (VEGFR2)-specific ultrasound molecular contrast agent (MCA), has shown promising results in multiple preclinical models regarding cancer imaging. In this first-in-human, phase 0, exploratory study, we investigated the feasibility and safety of the MCA for the detection of prostate cancer (PCa) in men using clinical standard technology. Imaging with the MCA was performed in 24 patients with biopsy-proven PCa scheduled for radical prostatectomy using a clinical ultrasound scanner at low acoustic power. Safety monitoring was done by physical examination, blood pressure and heart rate measurements, electrocardiogram, and blood sampling. As first-in-human study, MCA dosing and imaging protocol were necessarily fine-tuned along the enrollment to improve visualization. Imaging data were correlated with radical prostatectomy histopathology to analyze the detection rate of ultrasound molecular imaging with the MCA. Imaging with MCA doses of 0.03 and 0.05 mL/kg was adequate to obtain contrast enhancement images up to 30 minutes after administration. No serious adverse events or clinically meaningful changes in safety monitoring data were identified during or after administration. BR55 dosing and imaging were fine-tuned in the first 12 patients leading to 12 subsequent patients with an improved MCA dosing and imaging protocol. Twenty-three patients underwent radical prostatectomy. A total of 52 lesions were determined to be malignant by histopathology with 26 (50%) of them seen during BR55 imaging. In the 11 patients that were scanned with the improved protocol and underwent radical prostatectomy, a total of 28 malignant lesions were determined: 19 (68%) were seen during BR55 ultrasound molecular imaging, whereas 9 (32%) were not identified. Ultrasound molecular imaging with BR55 is feasible with clinical standard technology and demonstrated a good safety profile. Detectable levels of the MCA can be reached in patients with PCa opening the way for further clinical trials.

Simulating Data for Clinical Research: A Tutorial

ERIC Educational Resources Information Center

Beaujean, A. Alexander

2018-01-01

Simulation studies use computer-generated data to examine questions of interest that have traditionally been used to study properties of statistics and estimating algorithms. With the recent advent of powerful processing capabilities in affordable computers along with readily usable software, it is now feasible to use a simulation study to aid in…

Early Experience with a Brief, Multimodal, Multidisciplinary Treatment Program for Fibromyalgia

PubMed Central

Vincent, Ann; Whipple, Mary O.; Oh, Terry H.; Guderian, Janet A.; Barton, Debra L.; Luedtke, Connie A.

2014-01-01

Fibromyalgia is a complex, heterogeneous disorder for which a multidisciplinary individualized approach is currently advocated. We executed a 1 week multidisciplinary fibromyalgia clinical program with 7 patients, based on our previous experience with our existing 1.5 day multidisciplinary fibromyalgia program that has demonstrated both short- and long-term benefits. The current expanded program was not designed as a clinical study, but rather as a clinical feasibility assessment and was multidisciplinary in nature, with cognitive behavioral therapy, activity pacing and graded exercise therapy as major components. We assessed changes in individual patients at 1 week and 3 months following the program utilizing validated self-report measures of pain, fatigue, and self-efficacy. All patients indicated at least small improvements in pain and physical symptoms both at 1 week and 3 months and all but one patient showed improvement in self-efficacy at 1 week and 3 months. Similar trends were observed for fatigue. Based on our early clinical experience, we conclude that the 1 week multidisciplinary fibromyalgia program is logistically feasible and has potential for clinical efficacy. Further research is needed and is planned to test the clinical efficacy of this program and compare it with other interventions. PMID:24315246

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.

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.

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.

A feasibility study of a new computerised cognitive remediation for young adults with schizophrenia

PubMed Central

Cellard, Caroline; Reeder, Clare; Paradis-Giroux, Andrée-Anne; Roy, Marc-André; Gilbert, Elsa; Ivers, Hans; Bouchard, Roch-Hugo; Maziade, Michel; Wykes, Til

2016-01-01

Cognitive remediation therapy is effective for improving cognition, symptoms and social functioning in individuals with schizophrenia; however, the impact on visual episodic memory remains unclear. The objectives of this feasibility study were: (1) to explore whether or not CIRCuiTS—a new computerised cognitive remediation therapy programme developed in England—improves visual episodic memory and other cognitive domains in young adults with early course schizophrenia; and (2) to evaluate acceptability of the CIRCuiTS programme in French-Canadians. Three participants with visual episodic memory impairments at baseline were recruited from clinical settings in Canada, and consented to participate. Neuropsychological, clinical and social functioning was evaluated at baseline and post-treatment. Intervention involved 40 sessions of cognitive remediation. First, the reliable change index (RCI) revealed that each participant demonstrated significant post-therapy change in episodic memory and in other cognitive domains. The response profile was characterised by the use of organisational strategies. Second, the treatment was considered acceptable to participants in terms of session frequency (number of sessions per week), intensity (hours per week; total hours), and number of missed sessions and total completed sessions. This preliminary study yielded encouraging data demonstrating the feasibility of the CIRCuiTS programme in French-Canadian young adults with schizophrenia. PMID:25753694

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

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

Open-source mobile digital platform for clinical trial data collection in low-resource settings.

PubMed

van Dam, Joris; Omondi Onyango, Kevin; Midamba, Brian; Groosman, Nele; Hooper, Norman; Spector, Jonathan; Pillai, Goonaseelan Colin; Ogutu, Bernhards

2017-02-01

Governments, universities and pan-African research networks are building durable infrastructure and capabilities for biomedical research in Africa. This offers the opportunity to adopt from the outset innovative approaches and technologies that would be challenging to retrofit into fully established research infrastructures such as those regularly found in high-income countries. In this context we piloted the use of a novel mobile digital health platform, designed specifically for low-resource environments, to support high-quality data collection in a clinical research study. Our primary aim was to assess the feasibility of a using a mobile digital platform for clinical trial data collection in a low-resource setting. Secondarily, we sought to explore the potential benefits of such an approach. The investigative site was a research institute in Nairobi, Kenya. We integrated an open-source platform for mobile data collection commonly used in the developing world with an open-source, standard platform for electronic data capture in clinical trials. The integration was developed using common data standards (Clinical Data Interchange Standards Consortium (CDISC) Operational Data Model), maximising the potential to extend the approach to other platforms. The system was deployed in a pharmacokinetic study involving healthy human volunteers. The electronic data collection platform successfully supported conduct of the study. Multidisciplinary users reported high levels of satisfaction with the mobile application and highlighted substantial advantages when compared with traditional paper record systems. The new system also demonstrated a potential for expediting data quality review. This pilot study demonstrated the feasibility of using a mobile digital platform for clinical research data collection in low-resource settings. Sustainable scientific capabilities and infrastructure are essential to attract and support clinical research studies. Since many research structures in Africa are being developed anew, stakeholders should consider implementing innovative technologies and approaches.

Feasibility and safety of xenon compared with sevoflurane anaesthesia in coronary surgical patients: a randomized controlled pilot study.

PubMed

Stoppe, C; Fahlenkamp, A V; Rex, S; Veeck, N C; Gozdowsky, S C; Schälte, G; Autschbach, R; Rossaint, R; Coburn, M

2013-09-01

To date, only limited data exist about the use of xenon as an anaesthetic agent in patients undergoing cardiac surgery. The favourable cardio- and neuroprotective properties of xenon might attenuate postoperative complications, improve outcome, and reduce the incidence of delirium. Thus, the aims of this study were to investigate the feasibility and safety of balanced xenon anaesthesia in patients undergoing cardiac surgery and to gather pilot data for a future randomized multicentre study. Thirty patients undergoing elective coronary artery bypass grafting were enrolled in this randomized, single-blind controlled trial. They were randomized to receive balanced general anaesthesia with either xenon (45-50 vol%) or sevoflurane (1-1.4 vol%). The primary outcome was the occurrence of adverse events (AEs). Secondary outcome parameters were feasibility criteria (bispectral index, perioperative haemodynamic, and respiratory profile) and safety parameters (dosage of study treatments, renal function, intraoperative blood loss, need for inotropic support, regional cerebral tissue oxygenation). Furthermore, at predefined time points, systemic and pulmonary haemodynamics were assessed by the use of a pulmonary artery catheter. There were no patient characteristic differences between the groups. Patients undergoing xenon anaesthesia did not differ with respect to the incidence of AE (6 vs 8, P=0.464) compared with the sevoflurane group. No differences were detected regarding secondary feasibility and safety criteria. The haemodynamic and respiratory profile was comparable between the treatment groups. Balanced xenon anaesthesia is feasible and safe compared with sevoflurane anaesthesia in patients undergoing coronary artery bypass surgery. Acronym CARDIAX: A pre- and post-coronary artery bypass graft implantation disposed application of xenon. Clinical trial registration ClinicalTrials.gov: NCT01285271; EudraCT-number: 2010-023942-63. Approved by the ethics committee 'Ethik-Kommission an der Medizinischen Fakultät der Rheinisch-Westfälischen Technischen Hochschule Aachen (RWTH Aachen)': EK-218/10.

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.

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

Intraoperative intravital microscopy permits the study of human tumour vessels

PubMed Central

Fisher, Daniel T.; Muhitch, Jason B.; Kim, Minhyung; Doyen, Kurt C.; Bogner, Paul N.; Evans, Sharon S.; Skitzki, Joseph J.

2016-01-01

Tumour vessels have been studied extensively as they are critical sites for drug delivery, anti-angiogenic therapies and immunotherapy. As a preclinical tool, intravital microscopy (IVM) allows for in vivo real-time direct observation of vessels at the cellular level. However, to date there are no reports of intravital high-resolution imaging of human tumours in the clinical setting. Here we report the feasibility of IVM examinations of human malignant disease with an emphasis on tumour vasculature as the major site of tumour-host interactions. Consistent with preclinical observations, we show that patient tumour vessels are disorganized, tortuous and ∼50% do not support blood flow. Human tumour vessel diameters are larger than predicted from immunohistochemistry or preclinical IVM, and thereby have lower wall shear stress, which influences delivery of drugs and cellular immunotherapies. Thus, real-time clinical imaging of living human tumours is feasible and allows for detection of characteristics within the tumour microenvironment. PMID:26883450

Phase 2 trial of neoadjuvant chemotherapy and transoral endoscopic surgery with risk-adapted adjuvant therapy for squamous cell carcinoma of the head and neck.

PubMed

Weiss, Jared M; Grilley-Olson, Juneko E; Deal, Allison Mary; Zevallos, Jose P; Chera, Bhishamjit S; Paul, Jennifer; Knowles, Mary Fleming; Usenko, Dmitriy; Weissler, Mark C; Patel, Samip; Hayes, David N; Hackman, Trevor

2018-05-09

The objective of this study was to demonstrate the feasibility and efficacy of induction chemotherapy, surgery, and pathology-guided adjuvant therapy to treat transorally resectable squamous head and neck cancer. Patients had squamous head and neck cancer that was resectable by the transoral route and advanced-stage disease (American Joint Committee on Cancer stage III-IV, T3-T4 tumors, and/or positive lymph nodes). They received treatment with weekly carboplatin at an area under the curve of 2, plus paclitaxel 135 mg/m 2 , and daily lapatinib 1000mg for 6 weeks followed by surgical resection. Pathology that revealed margins <5 mm, extracapsular extension, N2a of N2b lymph node status, perineural invasion, or lymphovascular space invasion resulted in adjuvant radiotherapy concurrent with weekly cisplatin. Pathology with N2c/N3 lymph node status or positive margins resulted in radiation with bolus cisplatin. The primary endpoint was the clinical response rate to induction chemotherapy, and a key secondary endpoint was feasibility. Toxicity was modest, and 37 of 40 patients completed study procedures as planned. The clinical response rate was 93%, the pathologic complete response rate was 36%, and the clinical response did not predict for a pathologic complete response. No patient on study follow-up has recurred or died. Twenty-nine of 39 patients who underwent surgery avoided radiation. Speech and swallowing function were well preserved. The study met both its primary efficacy endpoint and the secondary feasibility endpoint. Neoadjuvant, systemic therapy and surgical resection followed by risk-adapted adjuvant therapy resulted in high response rates and excellent long-term outcomes and should be further studied. Cancer 2018. © 2018 American Cancer Society. © 2018 American Cancer Society.

Adult Congenital Heart Disease-Coping And REsilience (ACHD-CARE): Rationale and methodology of a pilot randomized controlled trial.

PubMed

Kovacs, Adrienne H; Bandyopadhyay, Mimi; Grace, Sherry L; Kentner, Amanda C; Nolan, Robert P; Silversides, Candice K; Irvine, M Jane

2015-11-01

One-third of North American adults with congenital heart disease (CHD) have diagnosable mood or anxiety disorders and most do not receive mental health treatment. There are no published interventions targeting the psychosocial needs of patients with CHD of any age. We describe the development of a group psychosocial intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD and the design of a study protocol to determine the feasibility of a potential full-scale randomized controlled trial (RCT). Drawing upon our quantitative and qualitative research, we developed the Adult CHD-Coping And REsilience (ACHD-CARE) intervention and designed a feasibility study that included a 2-parallel arm non-blinded pilot RCT. Eligible participants (CHD, age ≥ 18 years, no planned surgery, symptoms suggestive of a mood and/or anxiety disorder) were randomized to the ACHD-CARE intervention or Usual Care (1:1 allocation ratio). The group intervention was delivered during eight 90-minute weekly sessions. Feasibility will be assessed in the following domains: (i) process (e.g. recruitment and retention), (ii) resources, (iii) management, (iv) scientific outcomes, and (v) intervention acceptability. This study underscores the importance of carefully developing and testing the feasibility of psychosocial interventions in medical populations before moving to full-scale clinical trials. At study conclusion, we will be poised to make one of three determinations for a full-scale RCT: (1) feasible, (2) feasible with modifications, or (3) not feasible. This study will guide the future evaluation and provision of psychosocial treatment for adults with CHD. Copyright © 2015. Published by Elsevier Inc.

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

Tissue engineering of the bladder--reality or myth? A systematic review.

PubMed

Sloff, Marije; Simaioforidis, Vasileios; de Vries, Rob; Oosterwijk, Egbert; Feitz, Wout

2014-10-01

We systematically reviewed preclinical studies in the literature to evaluate the potential of tissue engineering of the bladder. Study outcomes were compared to the available clinical evidence to assess the feasibility of tissue engineering for future clinical use. Preclinical studies of tissue engineering for bladder augmentation were identified through a systematic search of PubMed and Embase™ from January 1, 1980 to January 1, 2014. Primary studies in English were included if bladder reconstruction after partial cystectomy was performed using a tissue engineered biomaterial in any animal species, with cystometric bladder capacity as an outcome measure. Outcomes were compared to clinical studies available at http://www.clinicaltrials.gov and published clinical studies. A total of 28 preclinical studies are included, demonstrating remarkable heterogeneity in study characteristics and design. Studies in which preoperative bladder volumes were compared to postoperative volumes were considered the most clinically relevant (18 studies). Bladder augmentation through tissue engineering resulted in a normal bladder volume in healthy animals, with the influence of a cellular component being negligible. Furthermore, experiments in large animal models (pigs and dogs) approximated the desired bladder volume more accurately than in smaller species. The initial clinical experience was based on seemingly predictive healthy animal models with a promising outcome. Unfortunately these results were not substantiated in all clinical trials, revealing dissimilar outcomes in different clinical/disease backgrounds. Thus, the translational predictability of a model using healthy animals might be questioned. Through this systematic approach we present an unbiased overview of all published preclinical studies investigating the effect of bladder tissue engineering on cystometric bladder capacity. Preclinical research in healthy animals appears to show the feasibility of bladder augmentation by tissue engineering. However, in view of the disappointing clinical results based on healthy animal models new approaches should also be evaluated in preclinical models using dysfunctional/diseased bladders. This endeavor may aid in the development of clinically applicable tissue engineered bladder augmentation with satisfactory long-term outcome. Copyright © 2014 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

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.

A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy.

PubMed

Brulé, David; Gillmeister, Biljana; Lee, Michelle; Alexander, Sarah; Gassas, Adam; Hendershot, Eleanor; Zupanec, Sue; Dupuis, Lee; Sung, Lillian

2016-12-01

Fatigue is a major problem in children with cancer. The objective was to examine the feasibility of performing a clinical trial of homeopathic treatment for fatigue in children receiving chemotherapy. This was a single-institution, open-label, pilot study. Children 2 to 18 years old, diagnosed with cancer, and receiving chemotherapy were eligible. Participants were given individualized homeopathic treatment for a maximum of 14 days. In-home or clinic assessments were conducted up to 3 times weekly. Feasibility was defined as the ability to recruit and administer homeopathy to 10 participants within 1 year. Fatigue was measured using the Symptom Distress Scale daily and the PedsQL Multidimensional Fatigue Module weekly. Between April 2012 and April 2014, 155 potential participants were identified. There were 45 eligible and contacted patients; 36 declined participation, 30 because they were not interested; 9 agreed to participate, but 1 participant withdrew prior to treatment initiation. Median length of homeopathic treatment was 10.5 (range = 6 to 14) days. All parents found homeopathic treatment to be easy or very easy to follow. Trials of individualized homeopathy for fatigue reduction in pediatric cancer are not feasible in this context; lack of interest was a primary reason. Alternative approaches to evaluating homeopathy efficacy are needed. © The Author(s) 2015.

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

A Mobile Health Platform for Clinical Monitoring in Early Psychosis: Implementation in Community-Based Outpatient Early Psychosis Care

PubMed Central

Iosif, Ana-Maria; Zakskorn, Lauren N; Nye, Kathleen E; Zia, Aqsa; Niendam, Tara Ann

2018-01-01

Background A growing body of literature indicates that smartphone technology is a feasible add-on tool in the treatment of individuals with early psychosis (EP) . However, most studies to date have been conducted independent of outpatient care or in a research clinic setting, often with financial incentives to maintain user adherence to the technology. Feasibility of dissemination and implementation of smartphone technology into community mental health centers (CMHCs) has yet to be tested, and whether young adults with EP will use this technology for long periods of time without incentive is unknown. Furthermore, although EP individuals willingly adopt smartphone technology as part of their treatment, it remains unclear whether providers are amenable to integrating smartphone technology into treatment protocols. Objective This study aimed to establish the feasibility of implementing a smartphone app and affiliated Web-based dashboard in 4 community outpatient EP clinics in Northern California. Methods EP individuals in 4 clinics downloaded an app on their smartphone and responded to daily surveys regarding mood and symptoms for up to 5 months. Treatment providers at the affiliated clinics viewed survey responses on a secure Web-based dashboard in sessions with their clients and between appointments. EP clients and treatment providers filled out satisfaction surveys at study end regarding usability of the app. Results Sixty-one EP clients and 20 treatment providers enrolled in the study for up to 5 months. Forty-one EP clients completed the study, and all treatment providers remained in the study for their duration in the clinic. Survey completion for all 61 EP clients was moderate: 40% and 39% for daily and weekly surveys, respectively. Completion rates were slightly higher in the participants who completed the study: 44% and 41% for daily and weekly surveys, respectively. Twenty-seven of 41 (66%) EP clients who completed the study and 11 of 13 (85%) treatment providers who responded to satisfaction surveys reported they would continue to use the app as part of treatment services. Six (15%; 6/41) clients and 3 providers (23%; 3/13) stated that technological glitches impeded their engagement with the platform. Conclusions EP clients and treatment providers in community-based outpatient clinics are responsive to integrating smartphone technology into treatment services. There were logistical and technical challenges associated with enrolling individuals in CMHCs. To be most effective, implementing smartphone technology in CMHC EP care necessitates adequate technical staff and support for utilization of the platform. PMID:29487044

A randomised controlled trial of six weeks of home enteral nutrition versus standard care after oesophagectomy or total gastrectomy for cancer: report on a pilot and feasibility study.

PubMed

Bowrey, David J; Baker, Melanie; Halliday, Vanessa; Thomas, Anne L; Pulikottil-Jacob, Ruth; Smith, Karen; Morris, Tom; Ring, Arne

2015-11-21

Poor nutrition in the first months after oesophago-gastric resection is a contributing factor to the reduced quality of life seen in these patients. The aim of this pilot and feasibility study was to ascertain the feasibility of conducting a multi-centre randomised controlled trial to evaluate routine home enteral nutrition in these patients. Patients undergoing oesophagectomy or total gastrectomy were randomised to either six weeks of home feeding through a jejunostomy (intervention), or treatment as usual (control). Intervention comprised overnight feeding, providing 50 % of energy and protein requirements, in addition to usual oral intake. Primary outcome measures were recruitment and retention rates at six weeks and six months. Nutritional intake, nutritional parameters, quality of life and healthcare costs were also collected. Interviews were conducted with a sample of participants, to ascertain patient and carer experiences. Fifty-four of 112 (48 %) eligible patients participated in the study over the 20 months. Study retention at six weeks was 41/54 patients (76 %) and at six months was 36/54 (67 %). At six weeks, participants in the control group had lost on average 3.9 kg more than participants in the intervention group (95 % confidence interval [CI] 1.6 to 6.2). These differences remained evident at three months (mean difference 2.5 kg, 95 % CI -0.5 to 5.6) and at six months (mean difference 2.5 kg, 95 % CI -1.2 to 6.1). The mean values observed in the intervention group for mid arm circumference, mid arm muscle circumference, triceps skin fold thickness and right hand grip strength were greater than for the control group at all post hospital discharge time points. The economic evaluation suggested that it was feasible to collect resource use and EQ-5D data for a full cost-effectiveness analysis. Thematic analysis of 15 interviews identified three main themes related to the intervention and the trial: 1) a positive experience, 2) the reasons for taking part, and 3) uncertainty of the study process. This study demonstrated that home enteral feeding by jejunostomy was feasible, safe and acceptable to patients and their carers. Whether home enteral feeding as 'usual practice' is a cost-effective therapy would require confirmation in an appropriately powered, multi-centre study. UK Clinical Research Network ID 12447 (main trial, first registered 30 May 2012); UK Clinical Research Network ID 13361 (qualitative substudy, first registered 30 May 2012); ClinicalTrials.gov NCT01870817 (first registered 28 May 2013).

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.

The feasibility of using Patients Concerns Inventory (PCI) in managing Malaysian oral cancer patients.

PubMed

Hatta, J M M; Doss, J G; Rogers, S N

2014-02-01

The feasibility of using the Patients Concerns Inventory (PCI) to identify oral cancer patient concerns during consultation in oral and maxillofacial specialist clinics in Malaysia was assessed. A cross-sectional study was conducted using a consecutive clinical sampling technique of all new and follow-up oral cancer patients. Surgeons and counter staff were also recruited. Two-thirds of patients were elderly, 63.9% female, 55.6% Indian, 63.9% of lower-level education, and half had the lowest level household income. Patient status was mostly post-treatment (87.5%) and most were at cancer stage III/IV (63.9%); 59.7% had surgery. Patients took an average 5.9 min (95% CI 5.1-6.7 min) to complete the PCI. Physical domain appeared highest (94.4%); social/family relationship issues (4.2%) were lowest. Significant associations included patient age-personal function (P=0.02); patient education level-emotional status (P=0.05) and social/family relationship issues (P=0.04), and patient TNM staging-personal function (P=0.03). The patients' mean feasibility score for the PCI was 5.3 (95% CI 5.1-5.5) out of 6. Patients (93.1%) and surgeons (90%) found the PCI to be feasible. Only 57.1% of counter staff agreed on the use of the PCI during patient registration. Overall, the PCI was considered feasible, thus favouring its future use in routine oral cancer patient management. Copyright © 2013. Published by Elsevier Ltd.

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

PubMed

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

2008-07-01

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

Novel Formulation Strategy to Improve the Feasibility of Amifostine Administration.

PubMed

Ranganathan, Kavitha; Simon, Eric; Lynn, Jeremy; Snider, Alicia; Zhang, Yu; Nelson, Noah; Donneys, Alexis; Rodriguez, Jose; Buchman, Lauren; Reyna, Dawn; Lipka, Elke; Buchman, Steven R

2018-03-19

Amifostine (AMF), a radioprotectant, is FDA-approved for intravenous administration in cancer patients receiving radiation therapy (XRT). Unfortunately, it remains clinically underutilized due to adverse side effects. The purpose of this study is to define the pharmacokinetic profile of an oral AMF formulation potentially capable of reducing side effects and increasing clinical feasibility. Calvarial osteoblasts were radiated under three conditions: no drug, AMF, and WR-1065 (active metabolite). Osteogenic potential of cells was measured using alkaline phosphatase staining. Next, rats were given AMF intravenously or directly into the jejunum, and pharmacokinetic profiles were evaluated. Finally, rats were given AMF orally or subcutaneously, and blood samples were analyzed for pharmacokinetics. WR-1065 preserved osteogenic potential of calvarial osteoblasts after XRT to a greater degree than AMF. Direct jejunal AMF administration incurred a systemic bioavailability of 61.5%. Subcutaneously administrated AMF yielded higher systemic levels, a more rapid peak exposure (0.438 vs. 0.875 h), and greater total systemic exposure of WR-1065 (116,756 vs. 16,874 ng*hr/ml) compared to orally administered AMF. Orally administered AMF achieves a similar systemic bioavailability and decreased peak plasma level of WR-1065 compared to intravenously administered AMF, suggesting oral AMF formulations maintain radioprotective efficacy without causing onerous side effects, and are clinically feasible.

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

Pain-QuILT: assessing clinical feasibility of a Web-based tool for the visual self-report of pain in an interdisciplinary pediatric chronic pain clinic.

PubMed

Lalloo, Chitra; Stinson, Jennifer N; Brown, Stephen C; Campbell, Fiona; Isaac, Lisa; Henry, James L

2014-11-01

To evaluate clinical feasibility of the Pain-QuILT (previously known as the Iconic Pain Assessment Tool) from the perspective of adolescents with chronic pain and members of their interdisciplinary health team. The Pain-QuILT (PQ), a web-based tool that records the visual self-report of sensory pain in the form of time-stamped records, was directly compared with standard interview questions that were transformed to a paper-based tool. Qualitative, semi-structured interviews were used to refine the PQ. Adolescents with chronic pain aged 12 to 18 years used the PQ and comparator tool (randomized order) to self-report pain before a scheduled clinic appointment, and then took part in a semi-structured interview. The health team used these pain reports (PQ and comparator) during patient appointments, and later participated in focus group interviews. Interview audio recordings were transcribed verbatim and underwent a simple line-by-line content analysis to identify key concepts. A total of 17 adolescents and 9 health team members completed the study. All adolescents felt that the PQ was easy to use and understand. The median time required for completion of the PQ and comparator tool was 3.3 and 3.6 minutes, respectively. Overall, 15/17 (88%) of adolescents preferred the PQ to self-report their pain versus the comparator. The health team indicated that the PQ was a clinically useful tool and identified minor barriers to implementation. Consultations with adolescents and their health team indicate that the PQ is a clinically feasible tool for eliciting detailed self-report records of the sensory experience of chronic pain.

The feasibility of employing a home healthcare model for education and treatment of opioid overdose using a naloxone auto-injector in a private practice pain medicine clinic.

PubMed

Dragovich, Anthony; Brason, Fred; Beltran, Thomas; McCoart, Amy; Plunkett, Anthony R

2018-04-18

The purpose of this study was to determine if employing a home healthcare model for education and treatment of opioid overdose using Evzio® (Naloxone)* auto-injector in a private practice pain clinic. A prospective survey was used to determine the feasibility of integrating a naloxone auto-injector within the patient's home with a home care training model. Twenty moderate or high-risk patients were enrolled from our chronic pain clinic. Patients who were moderate or high risk completed an evaluation survey. The naloxone auto-injector was dispensed to all patients meeting criteria. The treating provider after prescribing the naloxone auto-injector then consulted home health per standard clinical practice. All patients had home health consulted to perform overdose identification and rescue training. A Cochran's Q test was conducted to examine differences in patient knowledge pre and post training. The post training test was done 2-4 weeks later. Forty subjects enrolled after meeting inclusion/exclusion criteria. Twenty withdrew because their insurance declined coverage for the naloxone auto-injector. Those completing home health showed a statistically significant difference in their ability to correctly identify the steps needed to effectively respond to an overdose p = 0.03 Discussion: Preliminary evidence would suggest training on overdose symptom recognition and proper use of prescription naloxone for treatment in the home setting by home health staff would prove more beneficial than the clinic setting, but feasibility was hindered by unaffordable costs related to insurance coverage limitations.

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK

PubMed Central

Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

2017-01-01

Objectives To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Design Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. Setting 2 private herbal practices in the UK. Participants 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. Intervention 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Main outcome measures Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Results Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. Conclusions A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. Trial registration number ISRCTN 31072075; Results. PMID:28159846

IDEA intervention to prevent depressive symptoms and promote well-being in early-stage dementia: protocol for a randomised controlled feasibility study.

PubMed

Tuijt, Remco; Livingston, Gill; Gould, Rebecca L; Jones, Rebecca; Verdaguer, Elisabet Sole; Orgeta, Vasiliki

2018-02-08

Depressive symptoms are common among people with dementia, impacting quality of life and cognitive and functional decline. Currently, little is known about the acceptability and feasibility of psychological interventions for people with mild dementia, with recent reviews identifying the need for further evidence. Developing and evaluating psychological interventions to prevent and treat these symptoms is, therefore, an important clinical and research priority. This protocol describes a study testing the acceptability and feasibility of a manual-based behavioural activation (BA) intervention for preventing and treating depressive symptoms in people with mild dementia. The aim of this study is to explore the feasibility of conducting a pragmatic multicentre randomised controlled trial of clinical effectiveness of an eight-session intervention. The Intervention to prevent Depressive symptoms and promote well-being in EArly-stage dementia (IDEA) programme supports people with dementia and their family carers in identifying and scheduling enjoyable and meaningful activities. Sixty people who have received a diagnosis of dementia of any type in the last 6 months will be recruited via memory clinics. Further criteria are a Mini-Mental State Examination score of ≥20, and a family carer who can assist with the intervention. Consenting participants will be randomised in a ratio of 2:1 to BA or to treatment as usual. Analyses will estimate parameters such as rates of recruitment, retention and number of sessions completed. Questionnaires measuring depressive symptoms and quality of life for both the person with dementia and their carer will be completed at baseline, 3 and 6 months. Qualitative interviews will explore acceptability of the intervention, study procedures and experiences of the sessions. This study received a favourable ethical opinion from the London Camberwell St Giles Research Ethics Committee (16/LO/0540). We will disseminate findings at key conferences, the Alzheimer's Society and University College London websites and local stakeholder events. ISRCTN75503960; 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.

The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol.

PubMed

Levy, Natalie; Moynihan, Victoria; Nilo, Annielyn; Singer, Karyn; Bernik, Lidia S; Etiebet, Mary-Ann; Fang, Yixin; Cho, James; Natarajan, Sundar

2015-03-13

Patients on insulin glargine typically visit a clinician to obtain advice on how to adjust their insulin dose. These multiple clinic visits can be costly and time-consuming, particularly for low-income patients. It may be feasible to achieve insulin titration through text messages and phone calls with patients instead of face-to-face clinic visits. The objectives of this study are to (1) evaluate if the Mobile Insulin Titration Intervention (MITI) is clinically effective by helping patients reach their optimal dose of insulin glargine, (2) determine if the intervention is feasible within the setting and population, (3) assess patient satisfaction with the intervention, and (4) measure the costs associated with this intervention. This is a pilot study evaluating an approach to insulin titration using text messages and phone calls among patients with insulin-dependent type 2 diabetes in the outpatient medical clinic of Bellevue Hospital Center, a safety-net hospital in New York City. Patients will be randomized in a 1:1 ratio to either the MITI arm (texting/phone call intervention) or the usual-care arm (in-person clinic visits). Using a Web-based platform, weekday text messages will be sent to patients in the MITI arm, asking them to text back their fasting blood glucose values. In addition to daily reviews for alarm values, a clinician will rereview the texted values weekly, consult our physician-approved titration algorithm, and call the patients with advice on how to adjust their insulin dose. The primary outcome will be whether or not a patient reaches his/her optimal dose of insulin glargine within 12 weeks. Recruitment for this study occurred between June 2013 and December 2014. We are continuing to collect intervention and follow-up data from our patients who are currently enrolled. The results of our data analysis are expected to be available in 2015. This study explores the use of widely-available text messaging and voice technologies for insulin titration. We aim to show that remote insulin titration is clinically effective, feasible, satisfactory, and cost saving for low-income patients in a busy, urban clinic. Clinicaltrials.gov NCT01879579; http://clinicaltrials.gov/ct2/show/NCT01879579 (Archived by WebCite at http://www.webcitation.org/6WUEgjZUO).

The ClASsification for Psoriatic ARthritis (CASPAR) criteria--a retrospective feasibility, sensitivity, and specificity study.

PubMed

Tillett, William; Costa, Luisa; Jadon, Deepak; Wallis, Dinny; Cavill, Charlotte; McHugh, Jessica; Korendowych, Eleanor; McHugh, Neil

2012-01-01

To evaluate the sensitivity, specificity, and feasibility of the ClASsification criteria for Psoriatic ARthritis (CASPAR) to retrospectively classify an existing research cohort. In total, 480 patient records were reviewed from the Royal National Hospital for Rheumatic Diseases Psoriatic Arthritis (PsA) cohort and for 100 consecutive controls with inflammatory arthritis from a general rheumatology clinic. The CASPAR score was modified for retrospective use; both "inflammation" and "current psoriasis" were recorded as present if they had ever been confirmed in the rheumatology clinic. Sensitivity and specificity of the CASPAR criteria were compared with expert clinical diagnosis. A total of 480 database records were identified. Nine sets of records had been lost or destroyed. The diagnoses had changed in 15 cases, which were transferred to the control arm, leaving 456 patients with an expert diagnosis of PsA. Of 115 controls, 96 had rheumatoid arthritis, 5 osteoarthritis, 3 reactive arthritis, 3 seronegative arthritis, 3 undifferentiated arthralgia, 2 ankylosing spondylitis, 1 spondyloarthritis, and 2 systemic sclerosis. Sensitivity (99.7%) and specificity (99.1%) were both high and equivalent to previous reports. Sensitivity remained high even after inclusion of 7 PsA patients with insufficient data to complete the CASPAR assessment (sensitivity 98.2%, specificity 99.1%). The criteria were found to be easy and practical to apply to case records. Our study demonstrates that the feasibility, specificity, and sensitivity of the CASPAR are maintained when adapted for retrospective use to classify an established research cohort.

Identifying early dehydration risk with home-based sensors during radiation treatment: a feasibility study on patients with head and neck cancer.

PubMed

Peterson, Susan K; Shinn, Eileen H; Basen-Engquist, Karen; Demark-Wahnefried, Wendy; Prokhorov, Alexander V; Baru, Chaitanya; Krueger, Ingolf H; Farcas, Emilia; Rios, Philip; Garden, Adam S; Beadle, Beth M; Lin, Kai; Yan, Yan; Martch, Stephanie L; Patrick, Kevin

2013-12-01

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. 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. 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. Implementing CYCORE in a clinical oncology care setting is feasible and highly acceptable to both patients and providers.

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

Exceptional Responders Initial Feasibility Results

Cancer.gov

A pilot study evaluating identification of cancer patients who respond to treatment that is ineffective in at least 90 percent of patients found that it was indeed able to confirm a majority of proposed patients as exceptional responders based on clinical

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.

[The LESS (Laparo-endoscopic Single-Site) procedure in urology. Technical and clinical aspects].

PubMed

Neri, F; Cindolo, L; Gidaro, S; Schips, L

2010-01-01

Minimally invasive urology is rapidly advancing, and single-site laparoscopic surgery is being explored clinically. Such laparoscopic procedures are technically challenging and require an experienced laparoscopic surgeon due to the lack of port placement triangulation and instrument clashing. In the last years several surgeons all over the world have explored the feasibility and safety of LESS using several and different ports, approaches and devices. Hundreds of procedures have been described with overall favorable intraoperative and postoperative outcomes. Our experience consists of more than 30 procedures successfully completed for adrenal, kidney disease and varicocele. To date, LESS could be considered feasible and effective using currently available devices, however it is to be considered as an initial status technique requiring further confirmatory studies and advanced laparoscopic skills.

Conducting research in clinical psychology practice: Barriers, facilitators, and recommendations.

PubMed

Smith, Kirsten V; Thew, Graham R

2017-09-01

The combination of clinical psychologists' therapeutic expertise and research training means that they are in an ideal position to be conducting high-quality research projects. However, despite these skills and the documented benefits of research to services and service users, research activity in practice remains low. This article aims to give an overview of the advantages of, and difficulties in conducting research in clinical practice. We reviewed the relevant literature on barriers to research and reflected on our clinical and research experiences in a range of contexts to offer practical recommendations. We considered factors involved in the planning, sourcing support, implementation, and dissemination phases of research, and outline suggestions to improve the feasibility of research projects in post-qualification roles. We suggest that research leadership is particularly important within clinical psychology to ensure the profession's continued visibility and influence within health settings. Clinical implications Emerging evidence suggests that clinical settings that foster research are associated with better patient outcomes. Suggestions to increase the feasibility of research projects in clinical settings are detailed. Limitations The present recommendations are drawn from the authors' practical experience and may need adaptation to individual practitioners' settings. This study does not attempt to assess the efficacy of the strategies suggested. © 2017 The Authors. British Journal of Clinical Psychology published by John Wiley & Sons Ltd on behalf of British Psychological Society.

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.

An EHR Prototype Using Structured ISO/EN 13606 Documents to Respond to Identified Clinical Information Needs of Diabetes Specialists: A Controlled Study on Feasibility and Impact

PubMed Central

Huebner-Bloder, Gudrun; Duftschmid, Georg; Kohler, Michael; Rinner, Christoph; Saboor, Samrend; Ammenwerth, Elske

2012-01-01

Cross-institutional longitudinal Electronic Health Records (EHR), as introduced in Austria at the moment, increase the challenge of information overload of healthcare professionals. We developed an innovative cross-institutional EHR query prototype that offers extended query options, including searching for specific information items or sets of information items. The available query options were derived from a systematic analysis of information needs of diabetes specialists during patient encounters. The prototype operates in an IHE-XDS-based environment where ISO/EN 13606-structured documents are available. We conducted a controlled study with seven diabetes specialists to assess the feasibility and impact of this EHR query prototype on efficient retrieving of patient information to answer typical clinical questions. The controlled study showed that the specialists were quicker and more successful (measured in percentage of expected information items found) in finding patient information compared to the standard full-document search options. The participants also appreciated the extended query options. PMID:23304308

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.

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.

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

PubMed

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

2018-03-01

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

Feasibility of interactive technology for symptom monitoring in patients with fibromyalgia.

PubMed

Vanderboom, Catherine E; Vincent, Ann; Luedtke, Connie A; Rhudy, Lori M; Bowles, Kathryn H

2014-09-01

Use of health information technology (IT) integrated with clinical services has the potential to empower self-management and decrease health care utilization for chronic disorders such as fibromyalgia (FM). However, the appropriate methodology that systematically facilitates the integration of health IT with clinical services between patients and nurses partnering to manage FM is unclear. The purpose of this study was to determine the feasibility of technology-enhanced monitoring that engages FM patients using a mobile device. A quantitative and qualitative descriptive design was used in a convenience sample of 20 FM patients. Patients used a mobile monitoring device for one week; nurses responded to patient e-mailed symptom reports on a daily basis. Analysis was primarily descriptive-percent, frequencies, and means for individual questionnaire items and subscales were calculated. For qualitative data, a 1 hour focus group was audio-recorded, transcribed verbatim, and then analyzed using content analysis. All participants used a mobile phone in their daily lives; half used a smart phone. Participants were interested in using a smart phone to monitor their health and to communicate with health care providers. Participants used the study mobile device an average of 5.2 days out of the 7 day study period. Most participants (80%) reported that monitoring symptoms using the device was easy to do. Sixty-five percent felt that using the device helped them to promptly address their symptoms. Results from this study indicated that health IT integrated with clinical services is feasible to monitor FM symptoms and to communicate with the care team. Copyright © 2014 American Society for Pain Management Nursing. Published by Elsevier Inc. All rights reserved.

Applying a soft-robotic glove as assistive device and training tool with games to support hand function after stroke: Preliminary results on feasibility and potential clinical impact.

PubMed

Prange-Lasonder, Gerdienke B; Radder, Bob; Kottink, Anke I R; Melendez-Calderon, Alejandro; Buurke, Jaap H; Rietman, Johan S

2017-07-01

Recent technological developments regarding wearable soft-robotic devices extend beyond the current application of rehabilitation robotics and enable unobtrusive support of the arms and hands during daily activities. In this light, the HandinMind (HiM) system was developed, comprising a soft-robotic, grip supporting glove with an added computer gaming environment. The present study aims to gain first insight into the feasibility of clinical application of the HiM system and its potential impact. In order to do so, both the direct influence of the HiM system on hand function as assistive device and its therapeutic potential, of either assistive or therapeutic use, were explored. A pilot randomized clinical trial was combined with a cross-sectional measurement (comparing performance with and without glove) at baseline in 5 chronic stroke patients, to investigate both the direct assistive and potential therapeutic effects of the HiM system. Extended use of the soft-robotic glove as assistive device at home or with dedicated gaming exercises in a clinical setting was applicable and feasible. A positive assistive effect of the soft-robotic glove was proposed for pinch strength and functional task performance 'lifting full cans' in most of the five participants. A potential therapeutic impact was suggested with predominantly improved hand strength in both participants with assistive use, and faster functional task performance in both participants with therapeutic application.

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.

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).

Bilateral Symmetry of Visual Function Loss in Cone-Rod Dystrophies.

PubMed

Galli-Resta, Lucia; Falsini, Benedetto; Rossi, Giuseppe; Piccardi, Marco; Ziccardi, Lucia; Fadda, Antonello; Minnella, Angelo; Marangoni, Dario; Placidi, Giorgio; Campagna, Francesca; Abed, Edoardo; Bertelli, Matteo; Zuntini, Monia; Resta, Giovanni

2016-07-01

To investigate bilateral symmetry of visual impairment in cone-rod dystrophy (CRD) patients and understand the feasibility of clinical trial designs treating one eye and using the untreated eye as an internal control. This was a retrospective study of visual function loss measures in 436 CRD patients followed at the Ophthalmology Department of the Catholic University in Rome. Clinical measures considered were best-corrected visual acuity, focal macular cone electroretinogram (fERG), and Ganzfeld cone-mediated and rod-mediated electroretinograms. Interocular agreement in each of these clinical indexes was assessed by t- and Wilcoxon tests for paired samples, structural (Deming) regression analysis, and intraclass correlation. Baseline and follow-up measures were analyzed. A separate analysis was performed on the subset of 61 CRD patients carrying likely disease-causing mutations in the ABCA4 gene. Statistical tests show a very high degree of bilateral symmetry in the extent and progression of visual impairment in the fellow eyes of CRD patients. These data contribute to a better understanding of CRDs and support the feasibility of clinical trial designs involving unilateral eye treatment with the use of fellow eye as internal control.

Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial.

PubMed

Ander, Malin; Wikman, Anna; Ljótsson, Brjánn; Grönqvist, Helena; Ljungman, Gustaf; Woodford, Joanne; Lindahl Norberg, Annika; von Essen, Louise

2017-01-27

A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial. The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15-25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive-behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted. This feasibility protocol was approved by the Regional Ethical Review Board in Uppsala, Sweden (ref: 2016/210). Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences. ISRCTN97835363. 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/.

How can point-of-care HbA1c testing be integrated into UK primary care consultations? - A feasibility study.

PubMed

Hirst, J A; Stevens, R J; Smith, I; James, T; Gudgin, B C; Farmer, A J

2017-08-01

Point-of-care (POC) HbA1c testing gives a rapid result, allowing testing and treatment decisions to take place in a single appointment. Trials of POC testing have not been shown to improve HbA1c, possibly because of how testing was implemented. This study aimed to identify key components of POC HbA1c testing and determine strategies to optimise implementation in UK primary care. This cohort feasibility study recruited thirty patients with type 2 diabetes and HbA1c>7.5% (58mmol/mol) into three primary care clinics. Patients' clinical care included two POC HbA1c tests over six months. Data were collected on appointment duration, clinical decisions, technical performance and patient behaviour. Fifty-three POC HbA1c consultations took place during the study; clinical decisions were made in 30 consultations. Five POC consultations with a family doctor lasted on average 11min and 48 consultations with nurses took on average 24min. Five POC study visits did not take place in one clinic. POC results were uploaded to hospital records from two clinics. In total, sixty-three POC tests were performed, and there were 11 cartridge failures. No changes in HbA1c or patient behaviour were observed. HbA1c measurement with POC devices can be effectively implemented in primary care. This work has identified when these technologies might work best, as well as potential challenges. The findings can be used to inform the design of a pragmatic trial to implement POC HbA1c testing. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

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.

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.

Transdiagnostic and Transcultural: Pilot Study of Unified Protocol for Depressive and Anxiety Disorders in Japan.

PubMed

Ito, Masaya; Horikoshi, Masaru; Kato, Noriko; Oe, Yuki; Fujisato, Hiroko; Nakajima, Shun; Kanie, Ayako; Miyamae, Mitsuhiro; Takebayashi, Yoshitake; Horita, Ryo; Usuki, Masato; Nakagawa, Atsuo; Ono, Yutaka

2016-05-01

Unified protocol (UP) is a transdiagnostic cognitive behavior therapy for emotional disorders. It remains unknown whether UP is applicable for use in non-Western countries and for depressive disorders. We therefore examined its feasibility for a Japanese clinical population using this clinical trial design, which is multicentered, open-labeled, and single-armed (Clinical registry: UMIN000008322). The primary outcome was severity of anxiety symptoms, as assessed using Structured Interview Guide for the Hamilton Anxiety Rating Scale. Secondary outcomes were depressive symptoms, clinical global impression, functioning, quality of life, affectivity, emotion regulation, and adverse events. Of the 28 prospective participants, 17 were eligible and enrolled (depressive disorders=9, anxiety disorders=8). Severity of anxiety symptoms, which decreased significantly after the intervention, remained low for 3months (Hedges' g=1.29, 95% CI=0.56-2.06). Similar tendencies were observed for secondary outcome measures. No severe adverse event occurred. Two participants dropped out of the intervention. High treatment adherence and interrater reliability were confirmed. Results suggest the feasibility of UP in the Japanese context sufficient to warrant a larger clinical trial. Copyright © 2016. Published by Elsevier Ltd.

A self‐directed home yoga programme for women with breast cancer during chemotherapy: A feasibility study

PubMed Central

Yagasaki, Kaori; Yamauchi, Hideko; Yamauchi, Teruo; Takebayashi, Toru

2015-01-01

Recent studies suggest yoga as a promising approach for improving the cognitive function of cancer survivors. We studied whether a self‐directed home yoga programme was feasible for patients with breast cancer who were undergoing chemotherapy. Participants' preferences for the type of yoga course and the clinical effects of the programme were also assessed. In this study, 18 women (mean age, 43.9 years) were enrolled (44.7% recruitment rate). Of the participants, 63.6% had stage II cancer and 71.4% received adjuvant chemotherapy. Favourable retention (86%), adherence (94.4%) and acceptability (96.5%) rates were determined. Most (94.4%) of the women practiced the home programme more than twice a week on average. The participants preferred to gradually increase the intensity of the exercises. We only observed improvements in the cognitive aspects of fatigue. No serious adverse events were encountered during the programme. This self‐directed home yoga programme was safe and feasible for patients with breast cancer undergoing chemotherapy. PMID:26643264

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.

Brief Behavioral Intervention to Improve Adolescent Sexual Health: A Feasibility Study in the Emergency Department.

PubMed

Miller, Melissa K; Champassak, Sofie; Goggin, Kathy; Kelly, Patricia; Dowd, M Denise; Mollen, Cynthia J; Humiston, Sharon G; Linebarger, Jennifer; Apodaca, Timothy

2016-01-01

Although emergency department (ED) visits offer an opportunity to deliver brief behavioral interventions to improve health, provision of ED-based interventions targeting adolescent sexual health is uncommon. The objectives for this study were to evaluate the feasibility and preliminary effects of a novel sexual health service intervention for adolescents. In this cross-sectional feasibility study, sexually active patients aged 14 to 19 years presenting to a Midwestern pediatric ED were recruited to receive an intervention to improve sexual health. The intervention, based on motivational interviewing (MI), included agenda setting, exploration of behaviors, a decisional balance exercise, tailored feedback, and provision of personalized health services (including condoms, prescription for emergency contraception, urine testing for Chlamydia trachomatis and Neisseria gonorrheae, and referral to the hospital-affiliated adolescent clinic). Data were collected before and after intervention administration and at a 3-month follow-up telephone interview. Surveys assessed sexual risk behaviors, satisfaction with the intervention, health care use, and demographics. Feasibility criteria were (1) subject-rated interventionist fidelity to MI principles (Likert scale 1 [strongly agree] to 4 [strongly disagree]), (2) subject satisfaction (Likert scale 1 [not at all] to 5 [very]), and (3) session duration (minutes, recorded by the interventionist). A secondary outcome was the proportion of subjects who completed at least 1 health service. Services provided at the adolescent clinic were determined by an electronic medical record review. Comparisons of responses between sex subgroups were analyzed using Χ test. From August to November 2012, 69 adolescents were approached, 66 (96%) completed the screening survey, and 24 (37%) reported previous sexual activity. Of those, 20 (83%) agreed to participate. The mean (SD) age was 16.2 (1.4) years; 60% were female. Most (78%) reported that the interventionist maintained high fidelity to MI principles and most (80%) were very satisfied with the intervention. Mean (SD) intervention length was 15.7 (2.2) minutes. Most subjects (65%) accepted 1 or more health services, including 42% who completed clinic follow-up. In the ED or the referral clinic, the following services were provided to the subjects: condoms (n = 11), emergency contraception prescription (n = 5), C. trachomatis/N. gonorrheae testing (n = 4), hormonal birth control provision (n = 2), and human immunodeficiency virus testing (n = 3). Fifteen subjects (75%) were reached for the 3-month follow-up, and condom use was maintained by 67% of those reporting sexual activity. This study demonstrated the feasibility and potential utility of an MI-based service navigation intervention to connect youth with point-of-care services as well as resources for ongoing sexual health needs.

The clinical use of Skype--For which patients, with which problems and in which settings? A snapshot review of the literature.

PubMed

Armfield, Nigel R; Bradford, Madeleine; Bradford, Natalie K

2015-10-01

Low-cost and no-cost software-based video tools may be a feasible and effective way to provide some telemedicine services, particularly in low-resource settings. One of the most popular tools is Skype; it is freely available, may be installed on many types of devices, and is easy to use by clinicians and patients. While a previous review found no evidence in favor of, or against the clinical use of Skype, anecdotally it is believed to be widely used in healthcare for providing clinical services. However, the range of clinical applications in which Skype has been used has not been described. We aimed to identify and summarize the clinical applications of Skype. We reviewed the literature to identify studies that reported the use of Skype in clinical care or clinical education. We searched three electronic databases using the single search term "Skype". We found 239 unique articles. Twenty seven of the articles met our criteria for further review. The use of Skype was most prevalent in the management of chronic diseases such as cardiovascular diseases and diabetes, followed by educational and speech and language pathology applications. Most reported uses were in developed countries. In all but one case, Skype was reported by the authors to be feasible and to have benefit. However, while Skype may be a pragmatic approach to providing telemedicine services, in the absence of formal studies, the clinical and economic benefits remain unclear. Copyright © 2015. Published by Elsevier Ireland 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.

Safer laparoscopic trocar entry: it's all about pressure.

PubMed

Tsaltas, Jim; Pearce, Scott; Lawrence, Anthony; Meads, Alan; Mezzatesta, Joseph; Nicolson, Scott

2004-08-01

This prospective observational study aimed to assess the feasibility of adapting peritoneal hyperdistention to 25 mmHg during laparoscopy in an Australian hospital environment. A total of 1150 consecutive diagnostic or operative laparoscopies were performed. All cases were monitored for early detection of untoward physiological changes. All patients had Veress needle insufflation with distension to 25 mmHg prior to insertion of the primary trocar. No patients experienced any surgical entry complications or adverse clinical effects noted during anaesthetic. The aim of the current study is to assess the feasibility and safety of increasing the peritoneal insufflation pressure to 25 mmHg for primary trocar insertion.

Intradialytic Laughter Yoga therapy for haemodialysis patients: a pre-post intervention feasibility study.

PubMed

Bennett, Paul N; Parsons, Trisha; Ben-Moshe, Ros; Neal, Merv; Weinberg, Melissa K; Gilbert, Karen; Ockerby, Cherene; Rawson, Helen; Herbu, Corinne; Hutchinson, Alison M

2015-06-09

Laughter Yoga consists of physical exercise, relaxation techniques and simulated vigorous laughter. It has been associated with physical and psychological benefits for people in diverse clinical and non-clinical settings, but has not yet been tested in a haemodialysis setting. The study had three aims: 1) to examine the feasibility of conducting Laughter Yoga for patients with end stage kidney disease in a dialysis setting; 2) to explore the psychological and physiological impact of Laughter Yoga for these patients; and 3) to estimate the sample size required for future research. Pre/post intervention feasibility study. Eighteen participants were recruited into the study and Laughter Yoga therapists provided a four week intradialytic program (30-min intervention three times per week). Primary outcomes were psychological items measured at the first and last Laughter Yoga session, including: quality of life; subjective wellbeing; mood; optimism; control; self-esteem; depression, anxiety and stress. Secondary outcomes were: blood pressure, intradialytic hypotensive episodes and lung function (forced expiratory volume). Dialysis nurses exposed to the intervention completed a Laughter Yoga attitudes and perceptions survey (n = 11). Data were analysed using IBM SPSS Statistics v22, including descriptive and inferential statistics, and sample size estimates were calculated using G*Power. One participant withdrew from the study for medical reasons that were unrelated to the study during the first week (94 % retention rate). There were non-significant increases in happiness, mood, and optimism and a decrease in stress. Episodes of intradialytic hypotension decreased from 19 pre and 19 during Laughter Yoga to 4 post Laughter Yoga. There was no change in lung function or blood pressure. All nurses agreed or strongly agreed that Laughter Yoga had a positive impact on patients' mood, it was a feasible intervention and they would recommend Laughter Yoga to their patients. Sample size calculations for future research indicated that a minimum of 207 participants would be required to provide sufficient power to detect change in key psychological variables. This study provides evidence that Laughter Yoga is a safe, low-intensity form of intradialytic physical activity that can be successfully implemented for patients in dialysis settings. Larger studies are required, however, to determine the effect of Laughter Yoga on key psychological variables. Australian New Zealand Clinical Trials Registry - ACTRN12614001130651 . Registered 23 October 2014.

Multidisciplinary Pediatric Obesity Clinic via Telemedicine Within the Los Angeles Metropolitan Area: Lessons Learned.

PubMed

Slusser, Wendy; Whitley, Margaret; Izadpanah, Nilufar; Kim, Sion L; Ponturo, Don

2016-03-01

Telemedicine has been shown to be effective for rural populations, but little is reported on pediatric obesity care via telemedicine in urban settings. This study aims to assess feasibility and acceptability of multidisciplinary pediatric obesity care via telemedicine within the same metropolitan area in terms of information technology, coordination, patient care, and clinical outcomes. All project notes and communications were reviewed to extract key lessons from implementation. Patient and Provider Satisfaction Questionnaires were conducted to assess overall satisfaction; baseline and follow-up information were collected from chart reviews to evaluate clinical outcomes. Based on the questionnaires, 93% of responding patients (n = 28) and 88.3% of referring providers (n = 17) felt satisfied with the appointment. Chart review indicated a trend for decreased or stabilized body mass index and blood pressure (n = 32). Implementation of telemedicine for tertiary multidisciplinary pediatric obesity care in urban settings is both feasible and acceptable to patients and health care providers. © The Author(s) 2015.

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 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.

Wearable Sensors in Huntington Disease: A Pilot Study.

PubMed

Andrzejewski, Kelly L; Dowling, Ariel V; Stamler, David; Felong, Timothy J; Harris, Denzil A; Wong, Cynthia; Cai, Hang; Reilmann, Ralf; Little, Max A; Gwin, Joseph T; Biglan, Kevin M; Dorsey, E Ray

2016-06-18

The Unified Huntington's Disease Rating Scale (UHDRS) is the principal means of assessing motor impairment in Huntington disease but is subjective and generally limited to in-clinic assessments. To evaluate the feasibility and ability of wearable sensors to measure motor impairment in individuals with Huntington disease in the clinic and at home. Participants with Huntington disease and controls were asked to wear five accelerometer-based sensors attached to the chest and each limb for standardized, in-clinic assessments and for one day at home. A second chest sensor was worn for six additional days at home. Gait measures were compared between controls, participants with Huntington disease, and participants with Huntington disease grouped by UHDRS total motor score using Cohen's d values. Fifteen individuals with Huntington disease and five controls completed the study. Sensor data were successfully captured from 18 of the 20 participants at home. In the clinic, the standard deviation of step time (time between consecutive steps) was increased in Huntington disease (p < 0.0001; Cohen's d = 2.61) compared to controls. At home with additional observations, significant differences were observed in seven additional gait measures. The gait of individuals with higher total motor scores (50 or more) differed significantly from those with lower total motor scores (below 50) on multiple measures at home. In this pilot study, the use of wearable sensors in clinic and at home was feasible and demonstrated gait differences between controls, participants with Huntington disease, and participants with Huntington disease grouped by motor impairment.

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

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; Carter, Rickey E; Kor, Daryl J

2017-08-18

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. 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. 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. ClinicalTrials.gov registration number is NCT02094118 (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.

Feasibility of a Customized, In-Home, Game-Based Stroke Exercise Program Using the Microsoft Kinect® Sensor.

PubMed

Proffitt, Rachel; Lange, Belinda

2015-01-01

The objective of this study was to determine the feasibility of a 6-week, game-based, in-home telerehabilitation exercise program using the Microsoft Kinect® for individuals with chronic stroke. Four participants with chronic stroke completed the intervention based on games designed with the customized Mystic Isle software. The games were tailored to each participant's specific rehabilitation needs to facilitate the attainment of individualized goals determined through the Canadian Occupational Performance Measure. Likert scale questionnaires assessed the feasibility and utility of the game-based intervention. Supplementary clinical outcome data were collected. All participants played the games with moderately high enjoyment. Participant feedback helped identify barriers to use (especially, limited free time) and possible improvements. An in-home, customized, virtual reality game intervention to provide rehabilitative exercises for persons with chronic stroke is practicable. However, future studies are necessary to determine the intervention's impact on participant function, activity, and involvement.

A pilot study to evaluate the feasibility of individualized yoga for inpatient children receiving intensive chemotherapy.

PubMed

Diorio, Caroline; Schechter, Tal; Lee, Michelle; O'Sullivan, Cathy; Hesser, Tanya; Tomlinson, Deborah; Piscione, Janine; Armstrong, Christine; Tomlinson, George; Sung, Lillian

2015-01-24

Fatigue is an important problem in paediatric cancer patients and yoga may be an effective intervention. The primary objective was to determine the feasibility of individualized yoga for hospitalized children receiving intensive chemotherapy. We included English-speaking children and adolescents aged 7-18 years receiving intensive chemotherapy or haematopoietic stem cell transplantation (HSCT). Yoga was conducted three times weekly for three weeks. The primary outcome was feasibility, defined as ability to deliver at least 60% of planned sessions. Secondary outcomes were parent-reported Pediatric Quality of Life Inventory (PedsQL) Multidimensional Fatigue Scale, Fatigue Scale-Parent, PedsQL Generic Core Scales and PedsQL Acute Cancer Module. Between January and October 2013, 11 patients were enrolled. Median age was 14.0 (range 7.7-16.4) years and 6 (55%) were boys. Yoga was feasible with 10/11 participants meeting the threshold for feasibility. The median number of yoga sessions was 9 (range 3-13). No adverse events were attributed to yoga. Mean±standard deviation for the day 21 proxy-reported PedsQL general fatigue scores was 55.6±15.5. Qualitative comments suggested design changes for future yoga studies. Individualized yoga is feasible for inpatient children receiving intensive chemotherapy. Future work will include development and conduct of a randomized trial for fatigue amelioration. ClinicalTrials.gov NCT02105389.

The feasibility of paper-based Tracking Codes and electronic medical record systems to monitor tobacco-use assessment and intervention in an Individual Practice Association (IPA) Model health maintenance organization (HMO).

PubMed

Bentz, Charles J; Davis, Nancy; Bayley, Bruce

2002-01-01

Despite evidence of its effectiveness, tobacco cessation is not systematically addressed in routine healthcare settings. Its measurement is part of the problem. A pilot study was designed to develop and implement two different tobacco tracking systems in two independent primary care offices that participated in an IPA Model health maintenance organization in Portland, Oregon. The first clinic, which utilized a paper-based charting system, implemented CPT-like tracking codes to measure and report tobacco-cessation activities, which were eventually included in the managed-care organization's (MCO) claims database. The second clinic implemented an electronic tracking system based on its computerized electronic medical record (EMR) charting system. This paper describes the pilot study, including the processes involved in building provider acceptance for the new tracking systems in these two clinics, the barriers and successes encountered during implementation, and the resources expended by the clinics and by the MCO during the pilot. The findings from the 3-month implementation period were that documentation of tobacco-use status remained stable at 42-45% in the paper-based clinic and increased from 79% to 88% in the EMR clinic. This pilot study demonstrated that Tracking Codes are a feasible preventive-care tracking system in paper-based medical offices. However, high levels of effort and support are needed, and a critical mass of insurers and health plans would need to adopt Tracking Codes before widespread use could be expected. Results of the EMR-based tracking system are also reviewed and discussed.

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.

Multimodal activity monitoring for home rehabilitation of geriatric fracture patients--feasibility and acceptance of sensor systems in the GAL-NATARS study.

PubMed

Marschollek, Michael; Becker, Marcus; Bauer, Jürgen M; Bente, Petra; Dasenbrock, Lena; Elbers, Katharina; Hein, Andreas; Kolb, Gerald; Künemund, Harald; Lammel-Polchau, Christopher; Meis, Markus; Meyer Zu Schwabedissen, Hubertus; Remmers, Hartmut; Schulze, Mareike; Steen, Enno-Edzard; Thoben, Wilfried; Wang, Ju; Wolf, Klaus-Hendrik; Haux, Reinhold

2014-01-01

Demographic change will lead to a diminishing care workforce faced with rising numbers of older persons in need of care, suggesting meaningful use of health-enabling technologies, and home monitoring in particular, to contribute to supporting both the carers and the persons in need. We present and discuss the GAL-NATARS study design along with first results regarding technical feasibility of long-term home monitoring and acceptance of different sensor modalities. Fourteen geriatric participants with mobility-impairing fractures were recruited in three geriatric clinics. Following inpatient geriatric rehabilitation, their homes were equipped with ambient sensor components for three months. Additionally, a wearable accelerometer was employed. Technical feasibility was assessed by system and component downtimes, technology acceptance by face-to-face interviews. The overall system downtime was 6%, effected by two single events, but not by software failures. Technology acceptance was rated very high by all participants at the end of the monitoring periods, and no interference with their social lives was reported. Home-monitoring technologies were well-accepted by our participants. The information content of the data still needs to be evaluated with regard to clinical outcome parameters as well as the effect on the quality of life before recommending large-scale implementations.

Feasibility study for a biomedical experimental facility based on LEIR at CERN.

PubMed

Abler, Daniel; Garonna, Adriano; Carli, Christian; Dosanjh, Manjit; Peach, Ken

2013-07-01

In light of the recent European developments in ion beam therapy, there is a strong interest from the biomedical research community to have more access to clinically relevant beams. Beamtime for pre-clinical studies is currently very limited and a new dedicated facility would allow extensive research into the radiobiological mechanisms of ion beam radiation and the development of more refined techniques of dosimetry and imaging. This basic research would support the current clinical efforts of the new treatment centres in Europe (for example HIT, CNAO and MedAustron). This paper presents first investigations on the feasibility of an experimental biomedical facility based on the CERN Low Energy Ion Ring LEIR accelerator. Such a new facility could provide beams of light ions (from protons to neon ions) in a collaborative and cost-effective way, since it would rely partly on CERN's competences and infrastructure. The main technical challenges linked to the implementation of a slow extraction scheme for LEIR and to the design of the experimental beamlines are described and first solutions presented. These include introducing new extraction septa into one of the straight sections of the synchrotron, changing the power supply configuration of the magnets, and designing a new horizontal beamline suitable for clinical beam energies, and a low-energy vertical beamline for particular radiobiological experiments.

Feasibility study for a biomedical experimental facility based on LEIR at CERN

PubMed Central

Abler, Daniel; Garonna, Adriano; Carli, Christian; Dosanjh, Manjit; Peach, Ken

2013-01-01

In light of the recent European developments in ion beam therapy, there is a strong interest from the biomedical research community to have more access to clinically relevant beams. Beamtime for pre-clinical studies is currently very limited and a new dedicated facility would allow extensive research into the radiobiological mechanisms of ion beam radiation and the development of more refined techniques of dosimetry and imaging. This basic research would support the current clinical efforts of the new treatment centres in Europe (for example HIT, CNAO and MedAustron). This paper presents first investigations on the feasibility of an experimental biomedical facility based on the CERN Low Energy Ion Ring LEIR accelerator. Such a new facility could provide beams of light ions (from protons to neon ions) in a collaborative and cost-effective way, since it would rely partly on CERN's competences and infrastructure. The main technical challenges linked to the implementation of a slow extraction scheme for LEIR and to the design of the experimental beamlines are described and first solutions presented. These include introducing new extraction septa into one of the straight sections of the synchrotron, changing the power supply configuration of the magnets, and designing a new horizontal beamline suitable for clinical beam energies, and a low-energy vertical beamline for particular radiobiological experiments. PMID:23824122

The use of consumer depth cameras for 3D surface imaging of people with obesity: A feasibility study.

PubMed

Wheat, J S; Clarkson, S; Flint, S W; Simpson, C; Broom, D R

2018-05-21

Three dimensional (3D) surface imaging is a viable alternative to traditional body morphology measures, but the feasibility of using this technique with people with obesity has not been fully established. Therefore, the aim of this study was to investigate the validity, repeatability and acceptability of a consumer depth camera 3D surface imaging system in imaging people with obesity. The concurrent validity of the depth camera based system was investigated by comparing measures of mid-trunk volume to a gold-standard. The repeatability and acceptability of the depth camera system was assessed in people with obesity at a clinic. There was evidence of a fixed systematic difference between the depth camera system and the gold standard but excellent correlation between volume estimates (r 2 =0.997), with little evidence of proportional bias. The depth camera system was highly repeatable - low typical error (0.192L), high intraclass correlation coefficient (>0.999) and low technical error of measurement (0.64%). Depth camera based 3D surface imaging was also acceptable to people with obesity. It is feasible (valid, repeatable and acceptable) to use a low cost, flexible 3D surface imaging system to monitor the body size and shape of people with obesity in a clinical setting. Copyright © 2018 Asia Oceania Association for the Study of Obesity. Published by Elsevier Ltd. All rights reserved.

Clinical feasibility and efficacy of using virtual surgical planning in bimaxillary orthognathic surgery without intermediate splint.

PubMed

Li, Yunfeng; Jiang, Yangmei; Zhang, Nan; Xu, Rui; Hu, Jing; Zhu, Songsong

2015-03-01

Computer-aided jaw surgery has been extensively studied recently. The purpose of this study was to determine the clinical feasibility of performing bimaxillary orthognathic surgery without intermediate splint using virtual surgical planning and rapid prototyping technology. Twelve consecutive patients who underwent bimaxillary orthognathic surgery were included. The presented treatment plan here mainly consists of 6 procedures: (1) data acquisition from computed tomography (CT) of the skull and laser scanning of the dentition; (2) reconstruction and fusion of a virtual skull model with accurate dentition; (3) virtual surgery simulation including osteotomy and movement and repositioning of bony segments; (4) final surgical splint fabrication (no intermediate splint) using computer-aided design and rapid prototyping technology; (5) transfer of the virtual surgical plan to the operating room; and (6) comparison of the actual surgical outcome to the virtual surgical plan. All procedures of the treatment were successfully performed on all 12 patients. In quantification of differences between simulated and actual postoperative outcome, we found that the mean linear difference was less than 1.8 mm, and the mean angular difference was less than 2.5 degrees in all evaluated patients. Results from this study suggested that it was feasible to perform bimaxillary orthognathic surgery without intermediate splint. Virtual surgical planning and the guiding splints facilitated the diagnosis, treatment planning, accurate osteotomy, and bony segments repositioning in orthognathic surgery.

The Pain Course: Exploring the Feasibility of an Internet-delivered Pain Management Program When Offered by a Tertiary Pain Management Service.

PubMed

Dear, Blake F; Courtney, Catherine; Khor, Kok Eng; McDonald, Sarah; Ricciardi, Tahlia; Gandy, Milena; Fogliati, Vincent J; Titov, Nick

2018-06-01

This study examined the acceptability and preliminary outcomes of an internet-delivered pain management program, the Pain Course, when offered by a specialist pain management clinic in a large public hospital. A single-group feasibility open-trial design was used and 39 patients participated in the program, which ran for 8 weeks. Participants were supported through the program with weekly contact from a Clinical Psychologist at the clinic. All participants provided data at posttreatment and >90% of participants completed all 5 lessons of the course. High levels of satisfaction were observed and relatively little clinician time (M=71.99 min/participant; SD=32.82 min) was required to support patients through the program. Preliminary evidence of clinical improvements in depression symptoms (avg. improvement=38%; Cohen d=0.74), but not disability levels or anxiety symptoms, was observed in the overall sample. However, evidence of improvements was observed across all the primary outcomes among patients who had clinical levels of difficulties with disability (n=20; avg. improvement=11%; Cohen d=0.64), depression (n=17; avg. improvement=35%; Cohen d=1.24) and anxiety (n=8; avg. improvement=29%; Cohen d=0.57). These findings highlight the potential value of internet-delivered programs when provided by specialist pain management clinics as a part of their services and the value of larger scale studies in this area.

Interpreter training for medical students: pilot implementation and assessment in a student-run clinic.

PubMed

Diaz, Jennifer E L; Ekasumara, Nydia; Menon, Nikhil R; Homan, Edwin; Rajarajan, Prashanth; Zamudio, Andrés Ramírez; Kim, Annie J; Gruener, Jason; Poliandro, Edward; Thomas, David C; Meah, Yasmin S; Soriano, Rainier P

2016-09-29

Trained medical interpreters are instrumental to patient satisfaction and quality of care. They are especially important in student-run clinics, where many patients have limited English proficiency. Because student-run clinics have ties to their medical schools, they have access to bilingual students who may volunteer to interpret, but are not necessarily formally trained. To study the feasibility and efficacy of leveraging medical student volunteers to improve interpretation services, we performed a pilot study at the student-run clinic at the Icahn School of Medicine at Mount Sinai. In each fall semester in 2012-2015, we implemented a 6-h course providing didactic and interactive training on medical Spanish interpreting techniques and language skills to bilingual students. We then assessed the impact of the course on interpreter abilities. Participants' comfort levels, understanding of their roles, and understanding of terminology significantly increased after the course (p < 0.05), and these gains remained several months later (p < 0.05) and were repeated in an independent cohort. Patients and student clinicians also rated participants highly (averages above 4.5 out of 5) on these measures in real clinical encounters. These findings suggest that a formal interpreter training course tailored for medical students in the setting of a student-run clinic is feasible and effective. This program for training qualified student interpreters can serve as a model for other settings where medical students serve as interpreters.

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

PubMed

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

2014-10-01

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

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 single-blinded, randomized, parallel group superiority trial investigating the effects of footwear and custom foot orthoses versus footwear alone in individuals with patellofemoral joint osteoarthritis: a phase II pilot trial protocol.

PubMed

Wyndow, Narelle; Crossley, Kay M; Vicenzino, Bill; Tucker, Kylie; Collins, Natalie J

2017-01-01

Patellofemoral joint osteoarthritis is a common condition, yet information regarding conservative management is lacking. Foot orthoses are an effective intervention for improving pain and function in younger individuals with patellofemoral pain and may be effective in those with patellofemoral osteoarthritis. This pilot study will seek to establish the feasibility of a phase III randomised controlled trial to investigate whether foot orthoses worn in prescribed motion controlled footwear are superior to prescribed motion control footwear alone in the management of patellofemoral osteoarthritis. This phase II pilot clinical trial is designed as a randomized, single-blind, parallel group, two arm, superiority trial. The trial will recruit 44 participants from Queensland and Tasmania, Australia. Volunteers aged 40 years and over must have clinical symptoms and radiographic evidence of patellofemoral osteoarthritis to be eligible for inclusion. Those eligible will be randomized to receive either foot orthoses and prescribed motion control shoes, or prescribed motion control shoes alone, to be worn for a period of 4 months. The feasibility of a phase III clinical trial will be evaluated by assessing factors such as recruitment rate, number of eligible participants, participant compliance with the study protocol, adverse events, and drop-out rate. A secondary aim of the study will be to determine completion rates and calculate effect sizes for patient reported outcome measures such as knee-related symptoms, function, quality of life, kinesiophobia, self-efficacy, general and mental health, and physical activity at 2 and 4 months. Primary outcomes will be reported descriptively while effect sizes and 95% confidence intervals will be calculated for the secondary outcome measures. Data will be analysed using an intention-to-treat principle. The results of this pilot trial will help determine the feasibility of a phase III clinical trial investigating whether foot orthoses plus motion control footwear are superior to motion control footwear alone in individuals with patellofemoral osteoarthritis. A Phase III clinical trial will help guide footwear and foot orthoses recommendations in the clinical management of this disorder. Retrospectively registered with the Australian New Zealand Clinical Trials Registry: ACTRN12615000002583. Date registered: 07/01/15.

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…

Point-of-care lactate and creatinine analysis for sick obstetric patients at Queen Elizabeth Central Hospital in Blantyre, Malawi: A feasibility study.

PubMed

Glasmacher, S A; Bonongwe, P; Stones, W

2016-03-01

To achieve good outcomes in critically ill obstetric patients, it is necessary to identify organ dysfunction rapidly so that life-saving interventions can be appropriately commenced. However, timely access to clinical chemistry results is problematic, even in referral institutions, in the sub-Saharan African region. Reliable point-of-care tests licensed for clinical use are now available for lactate and creatinine. We aimed to assess whether implementation of point-of-care testing for lactate and creatinine is feasible in the obstetric unit at the Queen Elizabeth Central Hospital (QECH) in Blantyre, Malawi, by obtaining the opinions of clinical staff on the use of these tests in practice. During a two-month evaluation period nurse-midwives, medical interns, clinical officers, registrars, and consultants were given the opportunity to use StatStrip® and StatSensor® (Nova Biomedical, Waltham, USA) devices, for lactate and creatinine estimation, as part of their routine clinical practice in the obstetric unit. They were subsequently asked to complete a short questionnaire. Thirty-seven questionnaires were returned by participants: 22 from nurse-midwives and the remainder from clinicians. The mean satisfaction score for the devices was 7.6/10 amongst clinicians and 8.0/10 amongst nurse-midwives. The majority of participants stated that the obstetric high dependency unit (HDU) was the most suitable location for the devices. For lactate, 31 participants strongly agreed that testing should be continued and 24 strongly agreed that it would influence patient management. For creatinine, 29 strongly agreed that testing should be continued and 28 strongly agreed that it would influence their patient management. Twenty participants strongly agreed that they trust point-of-care devices. Point-of-care clinical chemistry testing was feasible, practical, and well received by staff, and was considered to have a useful role to play in the clinical care of sick obstetric patients at this referral centre.

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

Targeted hepatic sonography during clinic visits for detection of fatty liver in overweight children: a pilot study.

PubMed

Perito, Emily R; Tsai, Patrika M; Hawley, Sarah; Lustig, Robert H; Feldstein, Vickie A

2013-04-01

The purpose of this study was to assess the feasibility and utility of targeted hepatic sonography to evaluate for hepatic steatosis during a subspecialty clinic visit. In this pilot study, we performed targeted hepatic sonography on 25 overweight children aged 7 to 17 years consecutively seen in a pediatric obesity clinic. Long-axis images of the right lobe of the liver and a split-screen image of liver and spleen were taken. Images were interpreted in real time by the radiologist and shown to the family. Demographics, clinical measurements, and laboratory parameters were also collected from the specialty clinic visit on the same day. Sonography required a median of 4 minutes during the visit (interquartile range, 3-5 minutes). All consented patients completed the study. The median alanine aminotransferase (ALT) level was 23 U/L in those with no steatosis (n = 14), 26 U/L with mild steatosis (n = 6), and 41 U/L with moderate/marked steatosis (n = 5). Children with ALT levels of 25 to 50 U/L had very variable sonographic measures of hepatic steatosis. When the participants were categorized by the overall degree of fatty liver, hepatic steatosis was significantly associated with the aspartate aminotransferase level (P = .028), ALT level (P = .003), and diastolic blood pressure (P = .05) but did not correlate with age, sex, Latino race, or insulin resistance. Targeted hepatic sonography added information not apparent from routine ALT screening and provided immediate feedback to clinicians and families about the effect of obesity on end organs. This examination could be a feasible, informative addition to screening for children at high risk for nonalcoholic fatty liver disease who are seen in clinics that specialize in obesity.

Electronic patient-reported data capture as a foundation of rapid learning cancer care.

PubMed

Abernethy, Amy P; Ahmad, Asif; Zafar, S Yousuf; Wheeler, Jane L; Reese, Jennifer Barsky; Lyerly, H Kim

2010-06-01

"Rapid learning healthcare" presents a new infrastructure to support comparative effectiveness research. By leveraging heterogeneous datasets (eg, clinical, administrative, genomic, registry, and research), health information technology, and sophisticated iterative analyses, rapid learning healthcare provides a real-time framework in which clinical studies can evaluate the relative impact of therapeutic approaches on a diverse array of measures. This article describes an effort, at 1 academic medical center, to demonstrate what rapid learning healthcare might look like in operation. The article describes the process of developing and testing the components of this new model of integrated clinical/research function, with the pilot site being an academic oncology clinic and with electronic patient-reported outcomes (ePROs) being the foundational dataset. Steps included: feasibility study of the ePRO system; validation study of ePRO collection across 3 cancers; linking ePRO and other datasets; implementation; stakeholder alignment and buy in, and; demonstration through use cases. Two use cases are presented; participants were metastatic breast cancer (n = 65) and gastrointestinal cancer (n = 113) patients at 2 academic medical centers. (1) Patient-reported symptom data were collected with tablet computers; patients with breast and gastrointestinal cancer indicated high levels of sexual distress, which prompted multidisciplinary response, design of an intervention, and successful application for funding to study the intervention's impact. (2) The system evaluated the longitudinal impact of a psychosocial care program provided to patients with breast cancer. Participants used tablet computers to complete PRO surveys; data indicated significant impact on psychosocial outcomes, notably distress and despair, despite advanced disease. Results return to the clinic, allowing iterative update and evaluation. An ePRO-based rapid learning cancer clinic is feasible, providing real-time research-quality data to support comparative effectiveness research.

Combined Clinic-Home Approach for Upper Limb Robotic Therapy After Stroke: A Pilot Study.

PubMed

Kim, Grace J; Rivera, Lisa; Stein, Joel

2015-12-01

To investigate the feasibility of a combined clinic-home intervention using a robotic elbow brace and, secondarily, to collect preliminary data on the efficacy of this clinic-home intervention. Nonrandomized pre-/postinterventional study. Outpatient clinic and participants' homes. Individuals at least 6 months after stroke (N=11; 5 women and 6 men; mean age, 51.7y; mean time since stroke, 7.6y; mean Fugl-Meyer Assessment of the Upper Extremity [FMA-UE] score, 22 of 66) were enrolled from the community. Participants received training in an outpatient clinic from an experienced occupational therapist to gain independence with use of the device (3-9 sessions) followed by a 6-week home program using the device at home. Five instruments were administered before and after the study intervention: Modified Ashworth Scale, Box and Blocks test, FMA-UE, Arm Motor Ability Test, and Motor Activity Log-Amount of Use and Motor Activity Log-How Well subscales (MAL-AOU, MAL-HW). Nine participants completed the study. Participants used the device on average 42.9min/d, 5.3d/wk. The FMA-UE (t=3.32; P=.01), MAL-AOU (t=4.40; P=.002), and MAL-HW (t=4.02; P=.004) scores showed statistically significant improvement from baseline to discharge; the MAL-AOU (t=2.61; P=.035) and MAL-HW (t=2.47; P=.043) scores were also significantly improved from baseline to 3-month follow-up. This combined clinic-home intervention was feasible and effective. Participants demonstrated improvements in arm impairment and self-reported use of the arm from baseline to discharge; they continued to report significant improvement in actual use of the arm at 3-month follow-up. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Establishing the feasibility of direct observation in the assessment of tics in children with chronic tic disorders.

PubMed

Himle, Michael B; Chang, Susanna; Woods, Douglas W; Pearlman, Amanda; Buzzella, Brian; Bunaciu, Liviu; Piacentini, John C

2006-01-01

Behavior analysis has been at the forefront in establishing effective treatments for children and adults with chronic tic disorders. As is customary in behavior analysis, the efficacy of these treatments has been established using direct-observation assessment methods. Although behavior-analytic treatments have enjoyed acceptance and integration into mainstream health care practices for tic disorders (e.g., psychiatry and neurology), the use of direct observation as a primary assessment tool has been neglected in favor of less objective methods. Hesitation to use direct observation appears to stem largely from concerns about the generalizability of clinic observations to other settings (e.g., home) and a lack of consensus regarding the most appropriate and feasible techniques for conducting and scoring direct observation. The purpose of the current study was to evaluate and establish a reliable, valid, and feasible direct-observation protocol capable of being transported to research and clinical settings. A total of 43 children with tic disorders, collected from two outpatient specialty clinics, were assessed using direct (videotape samples) and indirect (Yale Global Tic Severity Scale; YGTSS) methods. Videotaped observation samples were collected across 3 consecutive weeks and two different settings (clinic and home), were scored using both exact frequency counts and partial-interval coding, and were compared to data from a common indirect measure of tic severity (the YGTSS). In addition, various lengths of videotaped segments were scored to determine the optimal observation length. Results show that (a) clinic-based observations correspond well to home-based observations, (b) brief direct-observation segments scored with time-sampling methods reliably quantified tics, and (c) indirect methods did not consistently correspond with the direct methods.

Feasibility of a shorter Goal Attainment Scaling method for a pediatric spasticity clinic - The 3-milestones GAS.

PubMed

Krasny-Pacini, A; Pauly, F; Hiebel, J; Godon, S; Isner-Horobeti, M-E; Chevignard, M

2017-07-01

Goal Attainment Scaling (GAS) is a method for writing personalized evaluation scales to quantify progress toward defined goals. It is useful in rehabilitation but is hampered by the experience required to adequately "predict" the possible outcomes relating to a particular goal before treatment and the time needed to describe all 5 levels of the scale. Here we aimed to investigate the feasibility of using GAS in a clinical setting of a pediatric spasticity clinic with a shorter method, the "3-milestones" GAS (goal setting with 3 levels and goal rating with the classical 5 levels). Secondary aims were to (1) analyze the types of goals children's therapists set for botulinum toxin treatment and (2) compare the score distribution (and therefore the ability to predict outcome) by goal type. Therapists were trained in GAS writing and prepared GAS scales in the regional spasticity-management clinic they attended with their patients and families. The study included all GAS scales written during a 2-year period. GAS score distribution across the 5 GAS levels was examined to assess whether the therapist could reliably predict outcome and whether the 3-milestones GAS yielded similar distributions as the original GAS method. In total, 541 GAS scales were written and showed the expected score distribution. Most scales (55%) referred to movement quality goals and fewer (29%) to family goals and activity domains. The 3-milestones GAS method was feasible within the time constraints of the spasticity clinic and could be used by local therapists in cooperation with the hospital team. Copyright © 2017 Elsevier Masson SAS. All rights reserved.

Prioritization in comparative effectiveness research: the CANCERGEN Experience.

PubMed

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

2012-05-01

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. 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. 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. A stakeholder group was created including representatives from patient-advocacy groups, payers, test developers, regulators, policy makers, and community-based oncologists. We identified 9 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 1 test in breast cancer (CEA/CA15-3/CA27.29) were identified as top research priorities. 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.

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

An electromechanical, patient positioning system for head and neck radiotherapy

NASA Astrophysics Data System (ADS)

Ostyn, Mark; Dwyer, Thomas; Miller, Matthew; King, Paden; Sacks, Rachel; Cruikshank, Ross; Rosario, Melvin; Martinez, Daniel; Kim, Siyong; Yeo, Woon-Hong

2017-09-01

In cancer treatment with radiation, accurate patient setup is critical for proper dose delivery. Improper arrangement can lead to disease recurrence, permanent organ damage, or lack of disease control. While current immobilization equipment often helps for patient positioning, manual adjustment is required, involving iterative, time-consuming steps. Here, we present an electromechanical robotic system for improving patient setup in radiotherapy, specifically targeting head and neck cancer. This positioning system offers six degrees of freedom for a variety of applications in radiation oncology. An analytical calculation of inverse kinematics serves as fundamental criteria to design the system. Computational mechanical modeling and experimental study of radiotherapy compatibility and x-ray-based imaging demonstrates the device feasibility and reliability to be used in radiotherapy. An absolute positioning accuracy test in a clinical treatment room supports the clinical feasibility of the system.

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

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

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.

Health-related quality of life and adherence to hydroxyurea in adolescents and young adults with sickle cell disease.

PubMed

Badawy, Sherif M; Thompson, Alexis A; Lai, Jin-Shei; Penedo, Frank J; Rychlik, Karen; Liem, Robert I

2017-06-01

Complications related to sickle cell disease (SCD) result in significant declines in health-related quality of life (HRQOL). While hydroxyurea reduces SCD complications, adherence remains suboptimal. The study's objectives were to assess the feasibility of Internet-based electronic assessment of HRQOL in SCD clinic and to examine the relationship between HRQOL and hydroxyurea adherence in adolescents and young adults (AYAs) with SCD. A cross-sectional survey was administered on tablets to 34 AYAs (12-22 years old) in a SCD clinic from January through December 2015. Study measures included Patient Reported Outcomes Measurement Information System (PROMIS ® ) computerized adaptive testing and ©Modified Morisky Adherence Scale 8-items (©MMAS-8). Participants (59% male, 91% Black) had median age of 13.5 (range 12-18) years. Ninety-one percent completed PROMIS® measures electronically in the clinic, meeting our feasibility criterion of ≥85% completion rate. ©MMAS-8 scores positively correlated with fetal hemoglobin (HbF) (r s = 0.34, P = 0.04) and mean corpuscular volume (MCV) (r s = 0.42, P = 0.01) and inversely correlated with fatigue (r s = -0.45, P = 0.01), depression (r s = -0.3, P = 0.08), and social isolation (r s = -0.78, P = 0.02). Low ©MMAS-8 scores, indicating poor adherence, were associated with worse fatigue (P = 0.001) and trended toward significance for pain (P = 0.07) and depression (P = 0.06). Homozygous hemoglobin S disease patients with low HbF (<16%) had worse social isolation (P = 0.04) and those with low MCV (<102 fl) reported worse fatigue (P = 0.001), pain (P = 0.01), mobility (P = 0.01), and social isolation (P = 0.04). HRQOL assessment in the SCD clinic is feasible. SCD patients with low hydroxyurea adherence and/or low HbF or MCV levels had worse HRQOL scores, particularly fatigue. Future prospective studies examining the relationship between HRQOL and hydroxyurea adherence are warranted. © 2016 Wiley Periodicals, Inc.

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

21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

21 CFR 601.91 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) BIOLOGICS LICENSING Approval of Biological Products When Human Efficacy Studies Are Not Ethical or Feasible § 601.91 Approval based on evidence of effectiveness from... reasonably likely to produce clinical benefit in humans. In assessing the sufficiency of animal data, the...

Preliminary Study of Resilience-Based Group Therapy for Improving the Functioning of Anxious Children

ERIC Educational Resources Information Center

Watson, Candice C.; Rich, Brendan A.; Sanchez, Lisa; O'Brien, Kelly; Alvord, Mary K.

2014-01-01

Background: There is a lack of research examining the feasibility of group psychotherapy interventions for anxious children in private clinical service settings. Furthermore, no research to date has examined the effectiveness of resilience-based interventions for helping children with anxiety disorders. Objective: The present study aims to examine…

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.

A comparison of remote therapy, face to face therapy and an attention control intervention for people with aphasia: a quasi-randomised controlled feasibility study.

PubMed

Woolf, Celia; Caute, Anna; Haigh, Zula; Galliers, Julia; Wilson, Stephanie; Kessie, Awurabena; Hirani, Shashi; Hegarty, Barbara; Marshall, Jane

2016-04-01

To test the feasibility of a randomised controlled trial comparing face to face and remotely delivered word finding therapy for people with aphasia. A quasi-randomised controlled feasibility study comparing remote therapy delivered from a University lab, remote therapy delivered from a clinical site, face to face therapy and an attention control condition. A University lab and NHS outpatient service. Twenty-one people with aphasia following left hemisphere stroke. Eight sessions of word finding therapy, delivered either face to face or remotely, were compared to an attention control condition comprising eight sessions of remotely delivered supported conversation. The remote conditions used mainstream video conferencing technology. Feasibility was assessed by recruitment and attrition rates, participant observations and interviews, and treatment fidelity checking. Effects of therapy on word retrieval were assessed by tests of picture naming and naming in conversation. Twenty-one participants were recruited over 17 months, with one lost at baseline. Compliance and satisfaction with the intervention was good. Treatment fidelity was high for both remote and face to face delivery (1251/1421 therapist behaviours were compliant with the protocol). Participants who received therapy improved on picture naming significantly more than controls (mean numerical gains: 20.2 (remote from University); 41 (remote from clinical site); 30.8 (face to face); 5.8 (attention control); P <.001). There were no significant differences between groups in the assessment of conversation. Word finding therapy can be delivered via mainstream internet video conferencing. Therapy improved picture naming, but not naming in conversation. © The Author(s) 2015.

Screening for Adverse Childhood Experiences in a Family Medicine Setting: A Feasibility Study.

PubMed

Glowa, Patricia T; Olson, Ardis L; Johnson, Deborah J

2016-01-01

The role of adverse childhood experiences (ACEs) in predicting later adverse adult health outcomes is being widely recognized by makers of public policy. ACE questionnaires have the potential to identify in clinical practice unaddressed key social issues that can influence current health risks, morbidity, and early mortality. This study seeks to explore the feasibility of implementing the ACE screening of adults during routine family medicine office visits. At 3 rural clinical practices, the 10-question ACE screen was used before visits with 111 consecutive patients of 7 clinicians. Clinician surveys about the use of the results and the effect on the visits were completed immediately after the visits. The presence of any ACE risk and "high-risk" ACE scores (≥4) were compared with clinician survey responses. A risk of ACEs was present in 62% of patients; 22% had scores ≥4. Clinicians were more likely to have discussed ACE issues for high-risk patients (score 0-3, 36.8%; score ≥4, 83.3%; P =. 00). Clinicians also perceived that they gained new information (score 0-3, 35.6%; score ≥4, 83.3%; P = .00). Clinical care changed for a small proportion of high-risk patients, with no change in immediate referrals or plan for follow-up. In 91% of visits where a risk of ACEs was present, visit length increased by ≤5 minutes. Incorporation of ACE screening during routine care is feasible and merits further study. ACE screening offers clinicians a more complete picture of important social determinants of health. Primary care-specific interventions that incorporate treatment of early life trauma are needed. © Copyright 2016 by the American Board of Family Medicine.

Odon device for instrumental vaginal deliveries: results of a medical device pilot clinical study.

PubMed

Schvartzman, Javier A; Krupitzki, Hugo; Merialdi, Mario; Betrán, Ana Pilar; Requejo, Jennifer; Nguyen, My Huong; Vayena, Effy; Fiorillo, Angel E; Gadow, Enrique C; Vizcaino, Francisco M; von Petery, Felicitas; Marroquin, Victoria; Cafferata, María Luisa; Mazzoni, Agustina; Vannevel, Valerie; Pattinson, Robert C; Gülmezoglu, A Metin; Althabe, Fernando; Bonet, Mercedes

2018-03-12

A prolonged and complicated second stage of labour is associated with serious perinatal complications. The Odon device is an innovation intended to perform instrumental vaginal delivery presently under development. We present an evaluation of the feasibility and safety of delivery with early prototypes of this device from an early terminated clinical study. Hospital-based, multi-phased, open-label, pilot clinical study with no control group in tertiary hospitals in Argentina and South Africa. Multiparous and nulliparous women, with uncomplicated singleton pregnancies, were enrolled during the third trimester of pregnancy. Delivery with Odon device was attempted under non-emergency conditions during the second stage of labour. The feasibility outcome was delivery with the Odon device defined as successful expulsion of the fetal head after one-time application of the device. Of the 49 women enrolled, the Odon device was inserted successfully in 46 (93%), and successful Odon device delivery as defined above was achieved in 35 (71%) women. Vaginal, first and second degree perineal tears occurred in 29 (59%) women. Four women had cervical tears. No third or fourth degree perineal tears were observed. All neonates were born alive and vigorous. No adverse maternal or infant outcomes were observed at 6-weeks follow-up for all dyads, and at 1 year for the first 30 dyads. Delivery using the Odon device is feasible. Observed genital tears could be due to the device or the process of delivery and assessment bias. Evaluating the effectiveness and safety of the further developed prototype of the BD Odon Device™ will require a randomized-controlled trial. ANZCTR ACTRN12613000141741 Registered 06 February 2013. Retrospectively registered.

Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature.

PubMed

Tofighi, Babak; Nicholson, Joseph M; McNeely, Jennifer; Muench, Frederick; Lee, Joshua D

2017-07-01

Mobile phone use has increased dramatically and concurrent with rapid developments in mobile phone-based health interventions. The integration of text messaging interventions promises to optimise the delivery of care for persons with substance dependence with minimal disruption to clinical workflows. We conducted a systematic review to assess the acceptability, feasibility and clinical impact of text messaging interventions for persons with illicit drug and alcohol dependence. Studies were required to evaluate the use of text messaging as an intervention for persons who met Diagnostic and Statistical Manual of Mental Disorders, 4th edition criterion for a diagnosis of illicit drug and/or alcohol dependence. Authors searched for articles published to date in MEDLINE (pubmed.gov), the Cochrane Library, EMBASE, CINAHL, Google Scholar and PsychINFO. Eleven articles met the search criteria for this review and support the acceptability and feasibility of text messaging interventions for addressing illicit drug and alcohol dependence. Most studies demonstrated improved clinical outcomes, medication adherence and engagement with peer support groups. Text messaging interventions also intervened on multiple therapeutic targets such as appointment attendance, motivation, self-efficacy, relapse prevention and social support. Suggestions for future research are described, including intervention design features, clinician contact, privacy measures and integration of behaviour change theories. Text messaging interventions offer a feasible platform to address a range of substances (i.e. alcohol, methamphetamine, heroin and alcohol), and there is increasing evidence supporting further larger-scale studies. [Tofighi B, Nicholson JM, McNeely J, Muench F, Lee JD. Mobile phone messaging for illicit drug and alcohol dependence: A systematic review of the literature. Drug Alcohol Rev 2017;36:477-491]. © 2017 Australasian Professional Society on Alcohol and other Drugs.

The First Intervention Study in Elder Self-Neglect: A Randomized Clinical Trial to Improve Vitamin D Levels

NASA Technical Reports Server (NTRS)

Burnett, Jason; Hochschild, Ann; Smith, Scott M.; Diamond, Pam; Stotts, Angela; Dyer, Carmel

2011-01-01

Despite high mortality rates, elder self-neglect is characterized by refusal of medical and social interventions. To date there have been no tested clinical interventions in elders who self-neglect. Previous research from the TEAM Institute has shown significantly low vitamin D levels in this population. This study aimed to determine the feasibility of a clinical intervention. Replacement of vitamin D was chosen because of its ease of administration and favorable safety profile. Methods: A randomized clinical trial using directly observed therapy of vitamin D was conducted using 50 elders, >65 years of age, with Adult Protective Services (APS) validated self-neglect. A staggered intervention with waiting controls was used to maximize statistical power. One-third (n=17) of the group was administered 50,000 IU vitamin D2 (ergocalciferol) monthly and the remainder (n=33) were administered 400 IU monthly. Serum 25-OH vitamin D was assessed at baseline and 5-months. Results: 69% agreed to participate in the study and of those n=40 (80%) remained at 5-months. At baseline, 12% (n=7) were deficient in vitamin D (<30nmol/L) and approximately 38% (n=22) had inadequate vitamin D levels (<50nmol/L). The baseline 25-OH vitamin D level was 59 nmol/L +25 (mean SD), and increased significantly to 72nmol/L +21 nmol/L at 5-months. Conclusion: These data are the first to provide evidence that clinical interventions are feasible in elders who self-neglect. The increase in vitamin D levels confirmed that the study personnel were able to successfully intervene community-dwelling elders with self-neglect. This study sets the precedent for future intervention and prevention studies

Motion compensation for MRI-compatible patient-mounted needle guide device: estimation of targeting accuracy in MRI-guided kidney cryoablations

NASA Astrophysics Data System (ADS)

Tokuda, Junichi; Chauvin, Laurent; Ninni, Brian; Kato, Takahisa; King, Franklin; Tuncali, Kemal; Hata, Nobuhiko

2018-04-01

Patient-mounted needle guide devices for percutaneous ablation are vulnerable to patient motion. The objective of this study is to develop and evaluate a software system for an MRI-compatible patient-mounted needle guide device that can adaptively compensate for displacement of the device due to patient motion using a novel image-based automatic device-to-image registration technique. We have developed a software system for an MRI-compatible patient-mounted needle guide device for percutaneous ablation. It features fully-automated image-based device-to-image registration to track the device position, and a device controller to adjust the needle trajectory to compensate for the displacement of the device. We performed: (a) a phantom study using a clinical MR scanner to evaluate registration performance; (b) simulations using intraoperative time-series MR data acquired in 20 clinical cases of MRI-guided renal cryoablations to assess its impact on motion compensation; and (c) a pilot clinical study in three patients to test its feasibility during the clinical procedure. FRE, TRE, and success rate of device-to-image registration were mm, mm, and 98.3% for the phantom images. The simulation study showed that the motion compensation reduced the targeting error for needle placement from 8.2 mm to 5.4 mm (p  <  0.0005) in patients under general anesthesia (GA), and from 14.4 mm to 10.0 mm () in patients under monitored anesthesia care (MAC). The pilot study showed that the software registered the device successfully in a clinical setting. Our simulation study demonstrated that the software system could significantly improve targeting accuracy in patients treated under both MAC and GA. Intraprocedural image-based device-to-image registration was feasible.

Prediction of black box warning by mining patterns of Convergent Focus Shift in clinical trial study populations using linked public data.

PubMed

Ma, Handong; Weng, Chunhua

2016-04-01

To link public data resources for predicting post-marketing drug safety label changes by analyzing the Convergent Focus Shift patterns among drug testing trials. We identified 256 top-selling prescription drugs between 2003 and 2013 and divided them into 83 BBW drugs (drugs with at least one black box warning label) and 173 ROBUST drugs (drugs without any black box warning label) based on their FDA black box warning (BBW) records. We retrieved 7499 clinical trials that each had at least one of these drugs for intervention from the ClinicalTrials.gov. We stratified all the trials by pre-marketing or post-marketing status, study phase, and study start date. For each trial, we retrieved drug and disease concepts from clinical trial summaries to model its study population using medParser and SNOMED-CT. Convergent Focus Shift (CFS) pattern was calculated and used to assess the temporal changes in study populations from pre-marketing to post-marketing trials for each drug. Then we selected 68 candidate drugs, 18 with BBW warning and 50 without, that each had at least nine pre-marketing trials and nine post-marketing trials for predictive modeling. A random forest predictive model was developed to predict BBW acquisition incidents based on CFS patterns among these drugs. Pre- and post-marketing trials of BBW and ROBUST drugs were compared to look for their differences in CFS patterns. Among the 18 BBW drugs, we consistently observed that the post-marketing trials focused more on recruiting patients with medical conditions previously unconsidered in the pre-marketing trials. In contrast, among the 50 ROBUST drugs, the post-marketing trials involved a variety of medications for testing their associations with target intervention(s). We found it feasible to predict BBW acquisitions using different CFS patterns between the two groups of drugs. Our random forest predictor achieved an AUC of 0.77. We also demonstrated the feasibility of the predictor for identifying long-term BBW acquisition events without compromising prediction accuracy. This study contributes a method for post-marketing pharmacovigilance using Convergent Focus Shift (CFS) patterns in clinical trial study populations mined from linked public data resources. These signals are otherwise unavailable from individual data resources. We demonstrated the added value of linked public data and the feasibility of integrating ClinicalTrials.gov summaries and drug safety labels for post-marketing surveillance. Future research is needed to ensure better accessibility and linkage of heterogeneous drug safety data for efficient pharmacovigilance. Copyright © 2016 Elsevier Inc. All rights reserved.

Recruitment of older adults to three preventative lifestyle improvement studies.

PubMed

Chatters, Robin; Newbould, Louise; Sprange, Kirsty; Hind, Daniel; Mountain, Gail; Shortland, Katy; Powell, Lauren; Gossage-Worrall, Rebecca; Chater, Tim; Keetharuth, Anju; Lee, Ellen; Woods, Bob

2018-02-20

Recruiting isolated older adults to clinical trials is complex, time-consuming and difficult. Previous studies have suggested querying existing databases to identify appropriate potential participants. We aim to compare recruitment techniques (general practitioner (GP) mail-outs, community engagement and clinician referrals) used in three randomised controlled trial (RCT) studies assessing the feasibility or effectiveness of two preventative interventions in isolated older adults (the Lifestyle Matters and Putting Life In Years interventions). During the three studies (the Lifestyle Matters feasibility study, the Lifestyle Matters RCT, the Putting Life In Years RCT) data were collected about how participants were recruited. The number of letters sent by GP surgeries for each study was recorded. In the Lifestyle Matters RCT, we qualitatively interviewed participants and intervention facilitators at 6 months post randomisation to seek their thoughts on the recruitment process. Referrals were planned to be the main source of recruitment in the Lifestyle Matters feasibility study, but due to a lack of engagement from district nurses, community engagement was the main source of recruitment. District nurse referrals and community engagement were also utilised in the Lifestyle Matters and Putting Life In Years RCTs; both mechanisms yielded few participants. GP mail-outs were the main source of recruitment in both the RCTs, but of those contacted, recruiting yield was low (< 3%). Facilitators of the Lifestyle Matters intervention questioned whether the most appropriate individuals had been recruited. Participants recommended that direct contact with health professionals would be the most beneficial way to recruit. Recruitment to the Lifestyle Matters RCT did not mirror recruitment to the feasibility study of the same intervention. Direct district nurse referrals were not effective at recruiting participants. The majority of participants were recruited via GP mail-outs, which may have led to isolated individuals not being recruited to the trials. Further research is required into alternative recruitment techniques, including respondent-driven sampling plus mechanisms which will promote health care professionals to recruit vulnerable populations to research. International Standard Randomised Controlled Trial Registry, ID: ISRCTN28645428 (Putting Life In Years RCT). Registered on 11 April 2012; International Standard Randomised Controlled Trial Registry, ID: ISRCTN67209155 (Lifestyle Matters RCT). Registered on 22 March 2012; ClinicalTrials.gov , ID: NCT03054311 (Lifestyle Matters feasibility study). Registered retrospectively on 19 January 2017.

Reliability, validity and feasibility of nail ultrasonography in psoriatic arthritis.

PubMed

Arbault, Anaïs; Devilliers, Hervé; Laroche, Davy; Cayot, Audrey; Vabres, Pierre; Maillefert, Jean-Francis; Ornetti, Paul

2016-10-01

To determine the feasibility, reliability and validity of nails ultrasonography in psoriatic arthritis as an outcome measure. Pilot prospective single-centre study of eight ultrasonography parameters in B mode and power Doppler concerning the distal interphalangeal (DIP) joint, the matrix, the bed and nail plate. Intra-observer and inter-observer reliability was evaluated for the seven quantitative parameters (ICC and kappa). Correlations between ultrasonography and clinical variables were searched to assess external validity. Feasibility was assessed by the time to carry out the examination and the percentage of missing data. Twenty-seven patients with psoriatic arthritis (age 55.0±16.2 years, disease duration 13.4±9.4 years) were included. Of these, 67% presented nail involvement on ultrasonography vs 37% on physical examination (P<0.05). Reliability was good (ICC and weighted kappa>0.75) for the seven quantitative parameters, except for synovitis of the DIP joint in B mode. The synovitis of the DIP joint revealed by ultrasonography correlated with the total number of clinical synovitis and Doppler US of the nail (matrix and bed). Doppler US of the matrix correlated with VAS pain but not with the ASDAS-CRP or with clinical enthesitis. No significant correlation was found with US nail thickness. The feasibility and reliability of ultrasonography of the nail in psoriatic arthritis appear to be satisfactory. Among the eight parameters evaluated, power Doppler of the matrix which correlated with local inflammation (DIP joint and bed) and with VAS pain could become an interesting outcome measure, provided that it is also sensitive to change. Copyright © 2015 Société française de rhumatologie. Published by Elsevier SAS. 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.

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

PubMed

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

2013-01-01

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

Texas Medication Algorithm Project: development and feasibility testing of a treatment algorithm for patients with bipolar disorder.

PubMed

Suppes, T; Swann, A C; Dennehy, E B; Habermacher, E D; Mason, M; Crismon, M L; Toprac, M G; Rush, A J; Shon, S P; Altshuler, K Z

2001-06-01

Use of treatment guidelines for treatment of major psychiatric illnesses has increased in recent years. The Texas Medication Algorithm Project (TMAP) was developed to study the feasibility and process of developing and implementing guidelines for bipolar disorder, major depressive disorder, and schizophrenia in the public mental health system of Texas. This article describes the consensus process used to develop the first set of TMAP algorithms for the Bipolar Disorder Module (Phase 1) and the trial testing the feasibility of their implementation in inpatient and outpatient psychiatric settings across Texas (Phase 2). The feasibility trial answered core questions regarding implementation of treatment guidelines for bipolar disorder. A total of 69 patients were treated with the original algorithms for bipolar disorder developed in Phase 1 of TMAP. Results support that physicians accepted the guidelines, followed recommendations to see patients at certain intervals, and utilized sequenced treatment steps differentially over the course of treatment. While improvements in clinical symptoms (24-item Brief Psychiatric Rating Scale) were observed over the course of enrollment in the trial, these conclusions are limited by the fact that physician volunteers were utilized for both treatment and ratings. and there was no control group. Results from Phases 1 and 2 indicate that it is possible to develop and implement a treatment guideline for patients with a history of mania in public mental health clinics in Texas. TMAP Phase 3, a recently completed larger and controlled trial assessing the clinical and economic impact of treatment guidelines and patient and family education in the public mental health system of Texas, improves upon this methodology.

Cognitive bias modification for social anxiety in adults who stutter: a feasibility study of a randomised controlled trial

PubMed Central

Gascoine, Sally; Carroll, Amy; Humby, Kate; Kingston, Mary; Shepstone, Lee; Risebro, Helen; Mackintosh, Bundy; Thompson, Tammy Davidson; Hodgekins, Jo

2017-01-01

Objective To determine the feasibility and acceptability of a computerised treatment for social anxiety disorder for adults who stutter including identification of recruitment, retention and completion rates, large cost drivers and selection of most appropriate outcome measure(s) to inform the design of a future definitive trial. Design Two-group parallel design (treatment vs placebo), double-blinded feasibility study. Participants: 31 adults who stutter. Intervention Attention training via an online probe detection task in which the stimuli were images of faces displaying neutral and disgusted expressions. Main outcome measures Psychological measures: Structured Clinical Interview Global Assessment of Functioning score; Liebowitz Social Anxiety Scale; Social Phobia and Anxiety Inventory; State-Trait Anxiety Inventory; Unhelpful Thoughts and Beliefs about Stuttering. Speech fluency: percent syllables stuttered. Economic evaluation: resource use questionnaire; EuroQol three-dimension questionnaire. Acceptability: Likert Scale questionnaire of experience of trial, acceptability of the intervention and randomisation procedure. Results Feasibility of recruitment strategy was demonstrated. Participant feedback indicated that the intervention and definitive trial, including randomisation, would be acceptable to adults who stutter. Of the 31 participants who were randomised, 25 provided data at all three data collection points. Conclusions The feasibility study informed components of the intervention. Modifications to the design are needed before a definitive trial can be undertaken. Trial registration number I SRCTN55065978; Post-results. PMID:29061602

Assessment of the feasibility and clinical value of further research to evaluate the management options for children with Down syndrome and otitis media with effusion: a feasibility study.

PubMed

Fortnum, Heather; Leighton, Paul; Smith, Murray D; Brown, Lisa; Jones, Matthew; Benton, Claire; Marder, Elizabeth; Marshall, Andrew; Sutton, Kate

2014-09-01

There is clinical uncertainty of the benefits and costs of different treatment options for children with Down syndrome who have glue ear. This study was designed to assess the extent of this lack of knowledge and determine if pursuing further information would be practical, beneficial and cost-effective. To assess the level and practical effect of current uncertainty around treatment options for children with Down syndrome and glue ear. To assess the feasibility of studying the options for management of glue ear in children with Down syndrome via a randomised controlled trial (RCT) or multicentre prospective cohort study by evaluating the willingness of (1) parents to agree to randomisation for their children and (2) clinicians to recruit participants to a definitive study. To undertake value of information analyses to demonstrate the potential economic benefit from undertaking further research. A feasibility study exploring the views of parents of children with Down syndrome and professionals who have responsibility for the health and education of children with Down syndrome, on the participation in, and value of, future research into interventions for glue ear. Data were collected from parents via self-completed questionnaires, face-to-face interviews and focus groups and from professionals via online questionnaires and a Delphi review exercise. Development of economic models to represent clinical pathways of care and a RCT informed a value of information (VOI) analysis. UK (professionals); East Midlands region of the UK (parents). Parents of children aged 1-11 years with Down syndrome (n = 156). Professionals including audiologists, ear, nose and throat surgeons, audiological physicians, speech and language therapists, and teachers of the deaf (n = 128). Quantitative and qualitative data on parental views and experiences of glue ear and its effects; interventions and treatment received; taking part in research and factors that would encourage or discourage participation; and the importance of various outcome domains to them and for their children. For professionals: information on caseloads; approaches to clinical management; opinions on frequency and significance of the consequences of glue ear for this population; importance of different outcome measures; opinions of interventions and their role in future research; views on health research; facilitators and barriers to recruitment, and participation in research involving RCTs. The complexity of the experience and individual characteristics of children with Down syndrome poses challenges for the design of any future research but these challenges were not considered by professionals to raise sufficient barriers to prevent it being undertaken. Parents were generally supportive of the need for, and value of, research but identified practical and emotional issues that would need addressing. Glue ear was considered to impact more on speech, language and communication than on hearing. Outcome measures for future research would need to evaluate these elements but measures should be designed specifically for the population. Parents and professionals identified randomisation as a significant barrier to participation. The VOI analyses identified lack of data as problematic but concluded that a future trial involving surgical intervention would be feasible at costs of < £650,000. Future research into the benefits of interventions for glue ear in children with Down syndrome would be feasible and could be cost-effective but should be carefully designed to facilitate and maximise participation from parents and professionals responsible for recruitment. The National Institute for Health Research Health Technology Assessment programme.

Implementing a knowledge translation intervention in long-term care: feasibility results from the Vitamin D and Osteoporosis Study (ViDOS).

PubMed

Kennedy, Courtney C; Thabane, Lehana; Ioannidis, George; Adachi, Jonathan D; Papaioannou, Alexandra

2014-12-01

To evaluate the feasibility of implementing an interdisciplinary, multifaceted knowledge translation intervention within long-term care (LTC) and to identify any challenges that should be considered in designing future studies. Cluster randomized controlled trial. Forty LTC homes across the province of Ontario, Canada. LTC teams composed of physicians, nurses, pharmacists, and other staff. Cluster-level feasibility measures, including recruitment, retention, data completion, and participation in the intervention. A process evaluation was completed by directors of care indicating which process/policy changes had been implemented. Recruitment and retention rates were 22% and 63%, respectively. Good fidelity with the intervention was achieved, including attendance at educational meetings. After ViDOS, 7 process indicators were being newly implemented by more than 50% of active intervention homes. Despite recruitment and retention challenges, the multifaceted intervention produced a number of policy/process changes and had good intervention fidelity. This study is registered at ClinicalTrials.gov NCT01398527. Copyright © 2014. Published by Elsevier Inc.

Effects of Diaphragmatic Breathing Patterns on Balance: A Preliminary Clinical Trial.

PubMed

Stephens, Rylee J; Haas, Mitchell; Moore, William L; Emmil, Jordan R; Sipress, Jayson A; Williams, Alex

The purpose of this study was to determine the feasibility of performing a larger study to determine if training in diaphragmatic breathing influences static and dynamic balance. A group of 13 healthy persons (8 men, 5 women), who were staff, faculty, or students at the University of Western States participated in an 8-week breathing and balance study using an uncontrolled clinical trial design. Participants were given a series of breathing exercises to perform weekly in the clinic and at home. Balance and breathing were assessed at the weekly clinic sessions. Breathing was evaluated with Liebenson's breathing assessment, static balance with the Modified Balance Error Scoring System, and dynamic balance with OptoGait's March in Place protocol. Improvement was noted in mean diaphragmatic breathing scores (1.3 to 2.6, P < .001), number of single-leg stance balance errors (7.1 to 3.8, P = .001), and tandem stance balance errors (3.2 to 0.9, P = .039). A decreasing error rate in single-leg stance was associated with improvement in breathing score within participants over the 8 weeks of the study (-1.4 errors/unit breathing score change, P < .001). Tandem stance performance did not reach statistical significance (-0.5 error/unit change, P = .118). Dynamic balance was insensitive to balance change, being error free for all participants throughout the study. This proof-of-concept study indicated that promotion of a costal-diaphragmatic breathing pattern may be associated with improvement in balance and suggests that a study of this phenomenon using an experimental design is feasible. Copyright © 2017. Published by Elsevier Inc.

Development and Preliminary Feasibility Study of a Brief Behavioral Activation Mobile Application (Behavioral Apptivation) to Be Used in Conjunction With Ongoing Therapy.

PubMed

Dahne, Jennifer; Kustanowitz, Jacob; Lejuez, C W

2018-02-01

Depressive symptoms are the most frequently treated psychiatric condition in the United States. Brief behavioral activation treatment for depression (BATD) is a popular, evidence-based psychotherapy with strong research support for the treatment of depression. In this paper, we describe the development and initial pilot feasibility testing of a BATD mobile application (Behavioral Apptivation) to be used by patients and therapists in conjunction with BATD therapy. We present information regarding the app development process as well as results from a small open-label feasibility trial of the app utilized in conjunction with individual BATD. We include a case series from the open-label trial highlighting how Behavioral Apptivation can be utilized in clinical practice.

Comparing the feasibility, acceptability, clinical-, and cost-effectiveness of mental health e-screening to paper-based screening on the detection of depression, anxiety, and psychosocial risk in pregnant women: a study protocol of a randomized, parallel-group, superiority trial.

PubMed

Kingston, Dawn; McDonald, Sheila; Biringer, Anne; Austin, Marie-Paule; Hegadoren, Kathy; McDonald, Sarah; Giallo, Rebecca; Ohinmaa, Arto; Lasiuk, Gerri; MacQueen, Glenda; Sword, Wendy; Lane-Smith, Marie; van Zanten, Sander Veldhuyzen

2014-01-02

Stress, depression, and anxiety affect 15% to 25% of pregnant women. However, substantial barriers to psychosocial assessment exist, resulting in less than 20% of prenatal care providers assessing and treating mental health problems. Moreover, pregnant women are often reluctant to disclose their mental health concerns to a healthcare provider. Identifying screening and assessment tools and procedures that are acceptable to both women and service providers, cost-effective, and clinically useful is needed. The primary objective of this randomized, parallel-group, superiority trial is to evaluate the feasibility and acceptability of a computer tablet-based prenatal psychosocial assessment (e-screening) compared to paper-based screening. Secondary objectives are to compare the two modes of screening on: (1) the level of detection of prenatal depression and anxiety symptoms and psychosocial risk; (2) the level of disclosure of symptoms; (3) the factors associated with feasibility, acceptability, and disclosure; (4) the psychometric properties of the e-version of the assessment tools; and (5) cost-effectiveness. A sample of 542 women will be recruited from large, primary care maternity clinics and a high-risk antenatal unit in an urban Canadian city. Pregnant women are eligible to participate if they: (1) receive care at one of the recruitment sites; (2) are able to speak/read English; (3) are willing to be randomized to e-screening; and (4) are willing to participate in a follow-up diagnostic interview within 1 week of recruitment. Allocation is by computer-generated randomization. Women in the intervention group will complete an online psychosocial assessment on a computer tablet, while those in the control group will complete the same assessment in paper-based form. All women will complete baseline questionnaires at the time of recruitment and will participate in a diagnostic interview within 1 week of recruitment. Research assistants conducting diagnostic interviews and physicians will be blinded. A qualitative descriptive study involving healthcare providers from the recruitment sites and women will provide data on feasibility and acceptability of the intervention. We hypothesize that mental health e-screening in primary care maternity settings and high-risk antenatal units will be as or more feasible, acceptable, and capable of detecting depression, anxiety, and psychosocial risk compared to paper-based screening. ClinicalTrials.gov Identifier: NCT01899534.

Rapid Multiplex PCR Assay To Identify Respiratory Viral Pathogens: Moving Forward Diagnosing The Common Cold

PubMed Central

Gordon, Sarah M; Elegino-Steffens, Diane U; Agee, Willie; Barnhill, Jason; Hsue, Gunther

2013-01-01

Upper respiratory tract infections (URIs) can be a serious burden to the healthcare system. The majority of URIs are viral in etiology, but definitive diagnosis can prove difficult due to frequently overlapping clinical presentations of viral and bacterial infections, and the variable sensitivity, and lengthy turn-around time of viral culture. We tested new automated nested multiplex PCR technology, the FilmArray® system, in the TAMC department of clinical investigations, to determine the feasibility of replacing the standard viral culture with a rapid turn-around system. We conducted a feasibility study using a single-blinded comparison study, comparing PCR results with archived viral culture results from a convenience sample of cryopreserved archived nasopharyngeal swabs from acutely ill ED patients who presented with complaints of URI symptoms. A total of 61 archived samples were processed. Viral culture had previously identified 31 positive specimens from these samples. The automated nested multiplex PCR detected 38 positive samples. In total, PCR was 94.5% concordant with the previously positive viral culture results. However, PCR was only 63.4% concordant with the negative viral culture results, owing to PCR detection of 11 additional viral pathogens not recovered on viral culture. The average time to process a sample was 75 minutes. We determined that an automated nested multiplex PCR is a feasible alternative to viral culture in an acute clinical setting. We were able to detect at least 94.5% as many viral pathogens as viral culture is able to identify, with a faster turn-around time. PMID:24052914

Selective decontamination of the digestive tract in critically ill patients treated in intensive care units: a mixed-methods feasibility study (the SuDDICU study).

PubMed

Francis, Jill J; Duncan, Eilidh M; Prior, Maria E; Maclennan, Graeme S; Dombrowski, Stephan; Bellingan, Geoff U; Campbell, Marion K; Eccles, Martin P; Rose, Louise; Rowan, Kathryn M; Shulman, Rob; Peter R Wilson, A; Cuthbertson, Brian H

2014-04-01

Hospital-acquired infections (HAIs) are a major cause of morbidity and mortality. Critically ill patients in intensive care units (ICUs) are particularly susceptible to these infections. One intervention that has gained much attention in reducing HAIs is selective decontamination of the digestive tract (SDD). SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of intravenous (i.v.) antibiotics. SDD may reduce infections and improve mortality, but has not been widely adopted in the UK or internationally. Hence, there is a need to identify the reasons for low uptake and whether or not further clinical research is needed before wider implementation would be considered appropriate. The project objectives were to (1) identify and describe the SDD intervention, (2) identify views about the evidence base, (3) identify acceptability of further research and (4) identify feasibility of further randomised controlled trials (RCTs). A four-stage approach involving (1) case studies of two ICUs in which SDD is delivered including observations, interviews and documentary analysis, (2) a three-round Delphi study for in-depth investigation of clinicians' views, including semi-structured interviews and two iterations of questionnaires with structured feedback, (3) a nationwide online survey of consultants in intensive care medicine and clinical microbiology and (4) semistructured interviews with international clinical triallists to identify the feasibility of further research. Case studies were set in two UK ICUs. Other stages of this research were conducted by telephone and online with NHS staff working in ICUs. (1) Staff involved in SDD adoption or delivery in two UK ICUs, (2) ICU experts (intensive care consultants, clinical microbiologists, hospital pharmacists and ICU clinical leads), (3) all intensive care consultants and clinical microbiologists in the UK with responsibility for patients in ICUs were invited and (4) international triallists, selected from their research profiles in intensive care, clinical trials and/or implementation trials. SDD involves the application of topical non-absorbable antibiotics to the oropharynx and stomach and a short course of i.v. antibiotics. Levels of support for, or opposition to, SDD in UK ICUs; views about the SDD evidence base and about barriers to implementation; and feasibility of further SDD research (e.g. likely participation rates). (1) The two case studies identified complexity in the interplay of clinical and behavioural components of SDD, involving multiple staff. However, from the perspective of individual staff, delivery of SDD was regarded as simple and straightforward. (2) The Delphi study (n = 42) identified (a) specific barriers to SDD implementation, (b) uncertainty about the evidence base and (c) bimodal distributions for key variables, e.g. support for, or opposition to, SDD. (3) The national survey (n = 468) identified uncertainty about the effect of SDD on antimicrobial resistance, infection rates, mortality and cost-effectiveness. Most participants would participate in further SDD research. (4) The triallist interviews (n = 10) focused largely on the substantial challenges of conducting a large, multinational clinical effectiveness trial. There was considerable uncertainty about possible benefits and harms of SDD. Further large-scale clinical effectiveness trials of SDD in ICUs may be required to address these uncertainties, especially relating to antimicrobial resistance. There was a general willingness to participate in a future effectiveness RCT of SDD. However, support was not unanimous. Future research should address the barriers to acceptance and participation in any trial. There was some, but a low level of, interest in adoption of SDD, or studies to encourage implementation of SDD into practice. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 25. See the NIHR Journals Library website for further project information.

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.

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

Fully integrated e-services for prevention, diagnosis, and treatment of sexually transmitted infections: results of a 4-county study in California.

PubMed

Spielberg, Freya; 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

2014-12-01

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. 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. 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. The fully integrated eSTI system has the potential to increase diagnosis and treatment of STIs with higher patient satisfaction at a potentially lower cost.

Implementation of the Cultural Formulation through a newly developed Brief Cultural Interview: Pilot data from the Netherlands.

PubMed

Groen, Simon P N; Richters, Annemiek; Laban, Cornelis J; Devillé, Walter L J M

2017-02-01

The Outline for a Cultural Formulation (OCF) has remained underutilized in clinical practice since its publication in the DSM-IV in 1994. In the Netherlands, a Cultural Interview (CI) was developed in 2002 as a tool to facilitate use of the OCF in clinical practice. The time needed to conduct the interview, however, prevented its systematic implementation within mental health institutions. This article presents the development of a shortened and adapted version, the Brief Cultural Interview (BCI), and a pilot study on the feasibility, acceptability, and utility of its implementation with refugee and asylum seeking patients in a Dutch centre for transcultural psychiatry. Results show that the brief version scores better on feasibility and acceptability, while utility for clinical practice remains similar to that of the original CI. These results support the systematic use of the OCF in psychiatric care for a culturally diverse patient population through the application of a relatively brief cultural interview. A secondary finding of the study is that patients' cultural identity was considered by clinicians to be more relevant in the treatment planning sessions than their illness explanations.

Virtual reality case-specific rehearsal in temporal bone surgery: a preliminary evaluation.

PubMed

Arora, Asit; Swords, Chloe; Khemani, Sam; Awad, Zaid; Darzi, Ara; Singh, Arvind; Tolley, Neil

2014-01-01

1. To investigate the feasibility of performing case-specific surgical rehearsal using a virtual reality temporal bone simulator. 2. To identify potential clinical applications in temporal bone surgery. Prospective assessment study. St Mary's Hospital, Imperial College NHS Trust, London UK. Sixteen participants consisting of a trainer and trainee group. Twenty-four cadaver temporal bones were CT-scanned and uploaded onto the Voxelman simulator. Sixteen participants performed a 90-min temporal bone dissection on the generic simulation model followed by 3 dissection tasks on the case simulation and cadaver models. Case rehearsal was assessed for feasibility. Clinical applications and usefulness were evaluated using a 5-point Likert-type scale. The upload process required a semi-automated system. Average time for upload was 20 min. Suboptimal reconstruction occurred in 21% of cases arising when the mastoid process and ossicular chain were not captured (n = 2) or when artefact was generated (n = 3). Case rehearsal rated highly (Likert score >4) for confidence (75%), facilitating planning (75%) and training (94%). Potential clinical applications for case rehearsal include ossicular chain surgery, cochlear implantation and congenital anomalies. Case rehearsal of cholesteatoma surgery is not possible on the current platform due to suboptimal soft tissue representation. The process of uploading CT data onto a virtual reality temporal bone simulator to perform surgical rehearsal is feasible using a semi-automated system. Further clinical evaluation is warranted to assess the benefit of performing patient-specific surgical rehearsal in selected procedures. Copyright © 2013 Surgical Associates Ltd. Published by Elsevier Ltd. All rights reserved.

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.

Feasibility, safety and cost of outpatient management of acute minor ischaemic stroke: a population-based study.

PubMed

Paul, Nicola L M; Koton, Silvia; Simoni, Michela; Geraghty, Olivia C; Luengo-Fernandez, Ramon; Rothwell, Peter M

2013-03-01

Outpatient management safely and effectively prevents early recurrent stroke after transient ischaemic attack (TIA), but this approach may not be safe in patients with acute minor stroke. To study outcomes of clinic and hospital-referred patients with TIA or minor stroke (National Institute of Health Stroke Scale score ≤3) in a prospective, population-based study (Oxford Vascular Study). Of 845 patients with TIA/stroke, 587 (69%) were referred directly to outpatient clinics and 258 (31%) directly to inpatient services. Of the 250 clinic-referred minor strokes (mean age 72.7 years), 237 (95%) were investigated, treated and discharged on the same day, of whom 16 (6.8%) were subsequently admitted to hospital within 30 days for recurrent stroke (n=6), sepsis (n=3), falls (n=3), bleeding (n=2), angina (n=1) and nursing care (n=1). The 150 patients (mean age 74.8 years) with minor stroke referred directly to hospital (median length-of-stay 9 days) had a similar 30-day readmission rate (9/150; 6.3%; p=0.83) after initial discharge and a similar 30-day risk of recurrent stroke (9/237 in clinic patients vs 8/150, OR=0.70, 0.27-1.80, p=0.61). Rates of prescription of secondary prevention medication after initial clinic/hospital discharge were higher in clinic-referred than in hospital-referred patients for antiplatelets/anticoagulants (p<0.05) and lipid-lowering agents (p<0.001) and were maintained at 1-year follow-up. The mean (SD) secondary care cost was £8323 (13 133) for hospital-referred minor stroke versus £743 (1794) for clinic-referred cases. Outpatient management of clinic-referred minor stroke is feasible and may be as safe as inpatient care. Rates of early hospital admission and recurrent stroke were low and uptake and maintenance of secondary prevention was high.

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.

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

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; Moon, Jae Hoon

2018-02-21

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. 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. 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. 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. 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. ClinicalTrials.gov NCT03009357; https://clinicaltrials.gov/ct2/show/NCT03009357 (Archived by WebCite at http://www.webcitation.org/6wh4MWPm2). ©Jie-Eun Lee, Dong Hwa Lee, Tae Jung Oh, Kyoung Min Kim, Sung Hee Choi, Soo Lim, Young Joo Park, Do Joon Park, Hak Chul Jang, Jae Hoon Moon. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 21.02.2018.

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 of a home-based program to improve handwriting after stroke: a pilot study.

PubMed

Simpson, Bronwyn; McCluskey, Annie; Lannin, Natasha; Cordier, Reinie

2016-01-01

To test the feasibility of a handwriting retraining program with adults after stroke; specifically the feasibility of: (i) recruiting people with stroke to the study, (ii) delivering the handwriting retraining program and (iii) outcome measures of handwriting performance. A quasi-experimental pre-test post-test design was used. A four-week, home-based handwriting retraining program was delivered by an occupational therapist using task-specific practice. Legibility, speed, pen control and self-perception of handwriting were measured at baseline and completion of the program. Legibility was scored by a blinded rater. Seven adults with stroke were recruited (eligibility fraction 43% of those screened, and enrolment fraction 78% of those eligible). There were no dropouts. Although, recruitment was slow the intervention was feasible and acceptable to adults with stroke. No statistically or clinically significant changes in legibility were reported in this small sample, but a ceiling effect was evident for some outcome measures. The study was not powered to determine efficacy. Delivery of a four-week handwriting intervention with eight supervised sessions in the community was feasible; however, recruitment of an adequate sample size would require greater investment than the single site used in this pilot. Handwriting difficulty is common following hemiparesis after stroke, however research addressing handwriting retraining for adults with stroke is lacking. A four-week home-based handwriting program using task-specific practice and feedback was feasible to deliver and appropriate for adults with stroke. Improving handwriting legibility and neatness across a range of tasks were important goals for adults with handwriting impairment.

The "Measuring Outcomes of Clinical Connectivity" (MOCC) trial: investigating data entry errors in the Electronic Primary Care Research Network (ePCRN).

PubMed

Fontaine, Patricia; Mendenhall, Tai J; Peterson, Kevin; Speedie, Stuart M

2007-01-01

The electronic Primary Care Research Network (ePCRN) enrolled PBRN researchers in a feasibility trial to test the functionality of the network's electronic architecture and investigate error rates associated with two data entry strategies used in clinical trials. PBRN physicians and research assistants who registered with the ePCRN were eligible to participate. After online consent and randomization, participants viewed simulated patient records, presented as either abstracted data (short form) or progress notes (long form). Participants transcribed 50 data elements onto electronic case report forms (CRFs) without integrated field restrictions. Data errors were analyzed. Ten geographically dispersed PBRNs enrolled 100 members and completed the study in less than 7 weeks. The estimated overall error rate if field restrictions had been applied was 2.3%. Participants entering data from the short form had a higher rate of correctly entered data fields (94.5% vs 90.8%, P = .004) and significantly more error-free records (P = .003). Feasibility outcomes integral to completion of an Internet-based, multisite study were successfully achieved. Further development of programmable electronic safeguards is indicated. The error analysis conducted in this study will aid design of specific field restrictions for electronic CRFs, an important component of clinical trial management systems.

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

PubMed

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

2012-11-01

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

Older adults and mobile phones for health: a review.

PubMed

Joe, Jonathan; Demiris, George

2013-10-01

To report on the results of a review concerning the use of mobile phones for health with older adults. PubMed and CINAHL were searched for articles using "older adults" and "mobile phones" along with related terms and synonyms between 1965 and June 2012. Identified articles were filtered by the following inclusion criteria: original research project utilizing a mobile phone as an intervention, involve/target adults 60 years of age or older, and have an aim emphasizing the mobile phone's use in health. Twenty-one different articles were found and categorized into ten different clinical domains, including diabetes, activities of daily life, and dementia care, among others. The largest group of articles focused on diabetes care (4 articles), followed by COPD (3 articles), Alzheimer's/dementia Care (3 articles) and osteoarthritis (3 articles). Areas of interest studied included feasibility, acceptability, and effectiveness. While there were many different clinical domains, the majority of studies were pilot studies that needed more work to establish a stronger base of evidence. Current work in using mobile phones for older adult use are spread across a variety of clinical domains. While this work is promising, current studies are generally smaller feasibility studies, and thus future work is needed to establish more generalizable, stronger base of evidence for effectiveness of these interventions. Copyright © 2013 Elsevier Inc. All rights reserved.

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

Detection of African swine fever, classical swine fever, and foot-and-mouth disease viruses in swine oral fluids by multiplex reverse transcription real-time polymerase chain reaction.

PubMed

Grau, Frederic R; Schroeder, Megan E; Mulhern, Erin L; McIntosh, Michael T; Bounpheng, Mangkey A

2015-03-01

African swine fever (ASF), classical swine fever (CSF), and foot-and-mouth disease (FMD) are highly contagious animal diseases of significant economic importance. Pigs infected with ASF and CSF viruses (ASFV and CSFV) develop clinical signs that may be indistinguishable from other diseases. Likewise, various causes of vesicular disease can mimic clinical signs caused by the FMD virus (FMDV). Early detection is critical to limiting the impact and spread of these disease outbreaks, and the ability to perform herd-level surveillance for all 3 diseases rapidly and cost effectively using a single diagnostic sample and test is highly desirable. This study assessed the feasibility of simultaneous ASFV, CSFV, and FMDV detection by multiplex reverse transcription real-time polymerase chain reaction (mRT-qPCR) in swine oral fluids collected through the use of chewing ropes. Animal groups were experimentally infected independently with each virus, observed for clinical signs, and oral fluids collected and tested throughout the course of infection. All animal groups chewed on the ropes readily before and after onset of clinical signs and before onset of lameness or serious clinical signs. ASFV was detected as early as 3 days postinoculation (dpi), 2-3 days before onset of clinical disease; CSFV was detected at 5 dpi, coincident with onset of clinical disease; and FMDV was detected as early as 1 dpi, 1 day before the onset of clinical disease. Equivalent results were observed in 4 independent studies and demonstrate the feasibility of oral fluids and mRT-qPCR for surveillance of ASF, CSF, and FMD in swine populations. © 2015 The Author(s).

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

PubMed

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

2011-09-01

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

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.

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

Standardised versus individualised multiherb Chinese herbal medicine for oligomenorrhoea and amenorrhoea in polycystic ovary syndrome: a randomised feasibility and pilot study in the UK.

PubMed

Lai, Lily; Flower, Andrew; Prescott, Philip; Wing, Trevor; Moore, Michael; Lewith, George

2017-02-03

To explore feasibility of a randomised study using standardised or individualised multiherb Chinese herbal medicine (CHM) for oligomenorrhoea and amenorrhoea in women with polycystic ovary syndrome (PCOS), to pilot study methods and to obtain clinical data to support sample size calculations. Prospective, pragmatic, randomised feasibility and pilot study with participant and practitioner blinding. 2 private herbal practices in the UK. 40 women diagnosed with PCOS and oligomenorrhoea or amenorrhoea following Rotterdam criteria. 6 months of either standardised CHM or individualised CHM, 16 g daily taken orally as a tea. Our primary objective was to determine whether oligomenorrhoea and amenorrhoea were appropriate as the primary outcome measures for the main study. Estimates of treatment effects were obtained for menstrual rate, body mass index (BMI), weight and hirsutism. Data were collected regarding safety, feasibility and acceptability. Of the 40 participants recruited, 29 (72.5%) completed the study. The most frequently cited symptoms of concern were hirsutism, weight and menstrual irregularity. Statistically significant improvements in menstrual rates were found at 6 months within group for both standardised CHM (mean difference (MD) 0.18±0.06, 95% CI 0.06 to 0.29; p=0.0027) and individualised CHM (MD 0.27±0.06, 95% CI 0.15 to 0.39; p<0.001), though not between group (p=0.26). No improvements were observed for BMI nor for weight in either group. Improvements in hirsutism scores found within group for both groups were not statistically significant between group (p=0.09). Liver and kidney function and adverse events data were largely normal. Participant feedback suggests changing to tablet administration could facilitate adherence. A CHM randomised controlled trial for PCOS is feasible and preliminary data suggest that both individualised and standardised multiherb CHMs have similar safety profiles and clinical effects on promoting menstrual regularity. These data will inform the design of a study in primary care that will incorporate an appropriate control. ISRCTN 31072075; Results. 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/.

Preventing childhood obesity, phase II feasibility study focusing on South Asians: BEACHeS

PubMed Central

Adab, Peymané; Pallan, Miranda J; Cade, Janet; Ekelund, Ulf; Barrett, Timothy; Daley, Amanda; Deeks, Jonathan; Duda, Joan; Gill, Paramjit; Parry, Jayne; Bhopal, Raj; Cheng, K K

2014-01-01

Objective To assess feasibility and acceptability of a multifaceted, culturally appropriate intervention for preventing obesity in South Asian children, and to obtain data to inform sample size for a definitive trial. Design Phase II feasibility study of a complex intervention. Setting 8 primary schools in inner city Birmingham, UK, within populations that are predominantly South Asian. Participants 1090 children aged 6–8 years took part in the intervention. 571 (85.9% from South Asian background) underwent baseline measures. 85.5% (n=488) were followed up 2 years later. Interventions The 1-year intervention consisted of school-based and family-based activities, targeting dietary and physical activity behaviours. The intervention was modified and refined throughout the period of delivery. Main outcome measures Acceptability and feasibility of the intervention and of measurements required to assess outcomes in a definitive trial. The difference in body mass index (BMI) z-score between arms was used to inform sample size calculations for a definitive trial. Results Some intervention components (increasing school physical activity opportunities, family cooking skills workshops, signposting of local leisure facilities and attending day event at a football club) were feasible and acceptable. Other components were acceptable, but not feasible. Promoting walking groups was neither acceptable nor feasible. At follow-up, children in the intervention compared with the control group were less likely to be obese (OR 0.41; 0.19 to 0.89), and had lower adjusted BMI z-score (−0.15 kg/m2; 95% CI −0.27 to −0.03). Conclusions The feasibility study informed components for an intervention programme. The favourable direction of outcome for weight status in the intervention group supports the need for a definitive trial. A cluster randomised controlled trial is now underway to assess the clinical and cost-effectiveness of the intervention. Trial registration number ISRCTN51016370. PMID:24722198

Balance and mobility training at home using Wii Fit in children with cerebral palsy: a feasibility study

PubMed Central

Ada, Louise; Lee, Shin-Da

2018-01-01

Objectives To investigate whether balance and mobility training at home using Wii Fit is feasible and can provide clinical benefits. Design Single-group, pre–post intervention study. Setting Participants’ home. Participants 20 children with cerebral palsy (6–12 years). Intervention Participants undertook 8 weeks of home-based Wii Fit training in addition to usual care. Main measures Feasibility was determined by adherence, performance, acceptability and safety. Clinical outcomes were strength, balance, mobility and participation measured at baseline (preintervention) and 8 weeks (postintervention). Results The training was feasible with 99% of training completed; performance on all games improved; parents understood the training (4/5), it did not interfere in life (3.8/5), was challenging (3.9/5) and would recommend it (3.9/5); and there were no injurious falls. Strength increased in dorsiflexors (Mean Difference (MD) 2.2 N m, 95% CI 1.1 to 3.2, p<0.001), plantarflexors (MD 2.2 N m, 95% CI 1.3 to 3.1, p<0.001) and quadriceps (MD 7.8 N m, 95% CI 5.2 to 10.5, p<0.001). Preferred walking speed increased (MD 0.25 m/s, 95% CI 0.09 to 0.41, p<0.01), fast speed increased (MD 0.24 m/s, 95% CI 0.13 to 0.35, p<0.001) and distance over 6 min increased (MD 28 m, 95% CI 10 to 45, p<0.01). Independence in participation increased (MD 1.4 out of 40, 95% CI 0.0 to 2.8, p=0.04). Conclusions Balance and mobility training at home using Wii Fit was feasible and safe and has the potential to improve strength and mobility, suggesting that a randomised trial is warranted. Trial registration number ACTRN12616001362482. PMID:29764871

Balance and mobility training at home using Wii Fit in children with cerebral palsy: a feasibility study.

PubMed

Chiu, Hsiu-Ching; Ada, Louise; Lee, Shin-Da

2018-05-15

To investigate whether balance and mobility training at home using Wii Fit is feasible and can provide clinical benefits. Single-group, pre-post intervention study. Participants' home. 20 children with cerebral palsy (6-12 years). Participants undertook 8 weeks of home-based Wii Fit training in addition to usual care. Feasibility was determined by adherence, performance, acceptability and safety. Clinical outcomes were strength, balance, mobility and participation measured at baseline (preintervention) and 8 weeks (postintervention). The training was feasible with 99% of training completed; performance on all games improved; parents understood the training (4/5), it did not interfere in life (3.8/5), was challenging (3.9/5) and would recommend it (3.9/5); and there were no injurious falls. Strength increased in dorsiflexors (Mean Difference (MD) 2.2 N m, 95% CI 1.1 to 3.2, p<0.001), plantarflexors (MD 2.2 N m, 95% CI 1.3 to 3.1, p<0.001) and quadriceps (MD 7.8 N m, 95% CI 5.2 to 10.5, p<0.001). Preferred walking speed increased (MD 0.25 m/s, 95% CI 0.09 to 0.41, p<0.01), fast speed increased (MD 0.24 m/s, 95% CI 0.13 to 0.35, p<0.001) and distance over 6 min increased (MD 28 m, 95% CI 10 to 45, p<0.01). Independence in participation increased (MD 1.4 out of 40, 95% CI 0.0 to 2.8, p=0.04). Balance and mobility training at home using Wii Fit was feasible and safe and has the potential to improve strength and mobility, suggesting that a randomised trial is warranted. ACTRN12616001362482. © 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.

[Selection of "surrogate" and "endpoints" evaluation of the efficacy of medical interventions].

PubMed

Lazebnik, L B; Gusein-Zade, M G; Efremov, L I

2011-01-01

With the advent of new medical technologies and medicines, as well as due to changes in disease patterns and demographic problems rises the need for continued increases in health spending. Increased costs can be totally inadequate, if it has been done without studying the effectiveness of medical interventions, based on the results of evidence-based medicine and economic of their feasibility. To evaluate the clinical effectiveness of medical interventions have been recently used specific criteria, so called points of clinical efficacy (surrogate and endpoints), that allow to conclude feasibility or harmfulness of the introduction or application of the intervention in clinical practice. The endpoint is reliable indicator the effectiveness of medical intervention. Surrogate point--is a biomarker that is intended to replace the endpoint and is a predictor of the effectiveness of medical intervention. The use of surrogate points has several advantages such as simple in identification and measurement, as well as more higher in compare with endpoints the vents frequency, that can significantly reduce the size of the selection and duration and cost of clinical trials, respectively. Finally, the surrogate points allow to evaluate treatment effect in situations where the use of endpoints is difficult or is unethical.

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.

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.

Demonstration of the Safety and Feasibility of Robotically Assisted Percutaneous Coronary Intervention in Complex Coronary Lesions: Results of the CORA-PCI Study (Complex Robotically Assisted Percutaneous Coronary Intervention).

PubMed

Mahmud, Ehtisham; Naghi, Jesse; Ang, Lawrence; Harrison, Jonathan; Behnamfar, Omid; Pourdjabbar, Ali; Reeves, Ryan; Patel, Mitul

2017-07-10

The aims of this study were to evaluate the feasibility and technical success of robotically assisted percutaneous coronary intervention (R-PCI) for the treatment of coronary artery disease (CAD) in clinical practice, especially in complex lesions, and to determine the safety and clinical success of R-PCI compared with manual percutaneous coronary intervention (M-PCI). R-PCI is safe and feasible for simple coronary lesions. The utility of R-PCI for complex coronary lesions is unknown. All consecutive PCI procedures performed robotically (study group) or manually (control group) over 18 months were included. R-PCI technical success, defined as the completion of the procedure robotically or with partial manual assistance and without a major adverse cardiovascular event, was determined. Procedures ineligible for R-PCI (i.e., atherectomy, planned 2-stent strategy for bifurcation lesion, chronic total occlusion requiring hybrid approach) were excluded for analysis from the M-PCI group. Clinical success, defined as completion of the PCI procedure without a major adverse cardiovascular event, procedure time, stent use, and fluoroscopy time were compared between groups. A total of 315 patients (mean age 67.7 ± 11.8 years; 78% men) underwent 334 PCI procedures (108 R-PCIs, 157 lesions, 78.3% type B2/C; 226 M-PCIs, 336 lesions, 68.8% type B2/C). Technical success with R-PCI was 91.7% (rate of manual assistance 11.1%, rate of manual conversion 7.4%, rate of major adverse cardiovascular events 0.93%). Clinical success (99.1% with R-PCI vs. 99.1% with M-PCI; p = 1.00), stent use (stents per procedure 1.59 ± 0.79 with R-PCI vs. 1.54 ± 0.75 with M-PCI; p = 0.73), and fluoroscopy time (18.2 ± 10.4 min with R-PCI vs. 19.2 ± 11.4 min with M-PCI; p = 0.39) were similar between the groups, although procedure time was longer in the R-PCI group (44:30 ± 26:04 min:s vs. 36:34 ± 23:03 min:s; p = 0.002). Propensity-matched analysis confirmed that procedure time was longer in the robotic group (42:59 ± 26:14 min:s with R-PCI vs. 34:01 ± 17:14 min:s with M-PCI; p = 0.007), although clinical success remained similar (98.8% with R-PCI vs. 100% with M-PCI; p = 1.00). This study demonstrates the feasibility, safety, and high technical success of R-PCI for the treatment of complex coronary disease. Furthermore, comparable clinical outcomes, without an adverse effect on stent use or fluoroscopy time, were observed with R-PCI and M-PCI. Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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,…

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.

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.

Improving outcomes in patients with coexisting multimorbid conditions-the development and evaluation of the combined diabetes and renal control trial (C-DIRECT): study protocol.

PubMed

Griva, Konstadina; Mooppil, Nandakumar; Khoo, Eric; Lee, Vanessa Yin Woan; Kang, Augustine Wee Cheng; Newman, Stanton P

2015-02-12

Diabetes mellitus (DM) is the most common cause of end-stage renal disease (ESRD). Patients with diabetes on dialysis have worse clinical outcomes and increased psychological burden. The need to manage the combined treatment demands for both conditions is particularly challenging yet there is paucity of data of the barriers preventing optimal management to combined therapy for diabetes and kidney failure. The study aims to explore needs of patients and develop an intervention to enable people with diabetes and ESRD to better manage both their conditions. A two-phase study comprising a mixed method observational study (phase I) and a feasibility trial (phase II). Phase I will seek to document outcomes and needs of the population (patients with DM-ESRD) and seek input on preferred delivery/implementation for the programme. Data will be collected with in-depth interviews with patients, caregivers and healthcare providers (N=50), and from a questionnaire-based survey (N=170). Phase 2 will build on these data to design and test the feasibility of a practical, low-intensity, clinic-integrated intervention using a self-management paradigm. The intervention will primarily seek to support behavioural change so as to improve adherence and clinical outcomes for DM as well as for ESRD. For the feasibility trial, we will be evaluating acceptability, retention and completion rates of the programme. The study protocol has been approved by the local ethics committee and written informed consent is required from every participant. Findings will be disseminated through journals, conferences and will be used to create a fully manualised intervention (materials) and training course for facilitators. 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.

Adding physical therapy services in the emergency department to prevent immobilization syndrome - a feasibility study in a university hospital.

PubMed

Tousignant-Laflamme, Yannick; Beaudoin, Ann-Marie; Renaud, Anne-Marie; Lauzon, Stephanie; Charest-Bossé, Marie-Catherine; Leblanc, Louise; Grégoire, Maryse

2015-12-03

The association between the functional decline occurring with bedrest and hospitalization in older persons is well-known. A long wait in the emergency department (ED), where patients can be bedridden, is a risk factor for the development of an immobilization syndrome (IS). IS is one of the unwanted consequences of inactivity, which causes pathological changes in most organs and systems. Early mobility interventions, such as physical therapy (PT) delivered in the ED, may prevent its development. To our knowledge, no prior studies have reported on this topic. The goal of this study was to (i) assess the feasibility and (ii) explore the potential clinical value of adding PT services to the ED, in collaboration with nursing staff, to prevent IS. For 12 weeks, PT services were delivered in the ED to older persons (>65 years old) presenting with ≥1 clinical signs associated with the development of IS. Patients were screened by ED nurses and then seen by the physiotherapist. In order to assess feasibility, access to patients, percentage of patients who met eligibility criteria, acceptability of the intervention, and barriers/facilitators to the implementation were measured. To describe the clinical benefits of early PT services, we counted the number of new IS cases among patients after their admission to the ward. After 12 weeks, the ED nurses screened 187 potential patients and 20 received PT services in the ED (before their admission to the ward). Accessibility was not an issue and we observed good acceptability from the milieu. We did not find majors problems or insurmountable obstacles to implementation of the intervention. Clinical outcomes showed that nine patients received PT treatments in the ED and on the ward (after their admission). For the 11 other patients, no PT interventions were done in the ED following the assessment. Follow-up of these 11 patients showed that two of them developed IS during their hospital stay. As for the nine patients who began PT treatments in the ED, none of them developed IS. Based on the results of this feasibility study, it would be likely and potentially beneficial to implement PT services in the ED, which could have a positive impact on preventing the development of IS in older persons presenting risk factors. While only a small proportion of patients (11 %) received PT services, better screening tools/methods should be developed.

Predicting intraoperative feasibility of combined TES-mMEP and cSSEP monitoring during scoliosis surgery based on preoperative neurophysiological assessment.

PubMed

Azabou, Eric; Manel, Véronique; Abelin-Genevois, Kariman; Andre-Obadia, Nathalie; Cunin, Vincent; Garin, Christophe; Kohler, Remi; Berard, Jérôme; Ulkatan, Sedat

2014-07-01

Combined monitoring of muscle motor evoked potentials elicited by transcranial electric stimulation (TES-mMEP) and cortical somatosensory evoked potentials (cSSEPs) is safe and effective for spinal cord monitoring during scoliosis surgery. However, TES-mMEP/cSSEP is not always feasible. Predictors of feasibility would help to plan the monitoring strategy. To identify predictors of the feasibility of TES-mMEP/cSSEP during scoliosis surgery. Prospective cohort study in a clinical neurophysiology unit and pediatric orthopedic department of a French university hospital. A total of 103 children aged 2 to 19 years scheduled for scoliosis surgery. Feasibility rate of intraoperative TES-mMEP/cSSEP monitoring. All patients underwent a preoperative neurological evaluation and preoperative mMEP and cSSEP recordings at both legs. For each factor associated with feasibility, we computed sensitivity, specificity, positive predictive value (PPV), and negative predictive value. A decision tree was designed. Presence of any of the following factors was associated with 100% feasibility, 100% specificity, and 100% PPV: idiopathic scoliosis, normal preoperative neurological findings, and normal preoperative mMEP and cSSEP recordings. Feasibility was 0% in the eight patients with no recordable mMEPs or cSSEPs during preoperative testing. A decision tree involving three screening steps can be used to identify patients in whom intraoperative TES-mMEP/cSSEP is feasible. Preoperative neurological and neurophysiological assessments are helpful for identifying patients who can be successfully monitored by TES-mMEP/cSSEP during scoliosis surgery. Copyright © 2014 Elsevier Inc. All rights reserved.

POTENTIAL EFFECTS OF WHOLE-BODY VIBRATION EXERCISES ON BLOOD FLOW KINETICS OF DIFFERENT POPULATIONS: A SYSTEMATIC REVIEW WITH A SUITABLE APPROACH.

PubMed

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

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. 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. 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. 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.

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.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

Feasibility and implementation of a literature information management system for human papillomavirus in head and neck cancers with imaging.

PubMed

Wu, Dee H; Matthiesen, Chance L; Alleman, Anthony M; Fournier, Aaron L; Gunter, Tyler C

2014-01-01

This work examines the feasibility and implementation of information service-orientated architecture (ISOA) on an emergent literature domain of human papillomavirus, head and neck cancer, and imaging. From this work, we examine the impact of cancer informatics and generate a full set of summarizing clinical pearls. Additionally, we describe how such an ISOA creates potential benefits in informatics education, enhancing utility for creating enduring digital content in this clinical domain.

21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2014 CFR

2014-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2012 CFR

2012-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

21 CFR 314.610 - Approval based on evidence of effectiveness from studies in animals.

Code of Federal Regulations, 2013 CFR

2013-04-01

... HEALTH AND HUMAN SERVICES (CONTINUED) DRUGS FOR HUMAN USE APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible § 314.610 Approval... establish that the drug product is reasonably likely to produce clinical benefit in humans. In assessing the...

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…

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.

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.

Applying evidence-based surgery in daily clinical routine: a feasibility study.

PubMed

Krahn, Jan; Sauerland, Stefan; Rixen, Dieter; Gregor, Sven; Bouillon, Bertil; Neugebauer, Edmund A M

2006-03-01

Although the word evidence-based medicine (EBM) has gained wide popularity, only a few studies have evaluated how EBM works in clinical practice. We have prospectively evaluated the feasibility of evidence-based trauma surgery. Orthopaedic trauma surgeons were asked to produce clinical questions related to the treatment of current patients. An informaticist searched the literature (Medline, Cochrane Library, practice guidelines and textbooks) and reported the findings on every following day. The study's main endpoints were the rate of questions for which relevant evidence (>level V) was available and the time necessary to find and critically appraise medical evidence. In total, 44 EBM questions were formulated, mainly concerning treatment options. PubMed was searched for 39 questions, textbooks for 14, the Cochrane Library for 11, online guidelines for 9 and other sources were used for 4 questions. On average, 157 text items (three per questions) were identified as potentially relevant. Journal articles predominated (83%) over textbooks (10%). Sixty-eight percent of the questions (30 of 44) were answered, either on the basis level 1 (n=13 questions), level 2 (n=6), or level 4 evidence (n=14). Trying to answer a question required 53 min on average, split up between 39 min of database searches and 25 min of obtaining full text articles. In four cases, the evidence suggested a change in clinical management. The physicians were very appreciative of our project and found the provided evidence very helpful for their clinical decisions. Time will be the main barrier against the introduction of clinical EBM. It is likely that clinicians reduce EBM to those situations where evidence is likely to be found. Although the impact of EBM on patient-care was limited, the concept of EBM was successfully implemented.

A pilot study of simple interventions to improve informed consent in clinical research: feasibility, approach, and results.

PubMed

Kass, Nancy E; Taylor, Holly A; Ali, Joseph; Hallez, Kristina; Chaisson, Lelia

2015-02-01

Research suggests that participants do not always adequately understand studies. While some consent interventions increase understanding, methodologic challenges have been raised in studying consent outside of actual trial settings. This study examined the feasibility of testing two consent interventions in actual studies and measured effectiveness of interventions in improving understanding. Participants enrolling in any of eight ongoing clinical trials were sequentially assigned to one of three different informed consent strategies for enrollment in their clinical trial. Control participants received standard consent procedures for their trial. Participants in the first intervention arm received a bulleted fact sheet summarizing key study information. Participants in the second intervention arm received the bulleted fact sheet and also engaged in a feedback Q&A session. Later, patients answered closed- and open-ended questions to assess patient understanding and literacy. Descriptive statistics, Wilcoxon -Mann -Whitney and Kruskal-Wallis tests were generated to assess correlations; regression analysis determined predictors of understanding. 144 participants enrolled. Using regression analysis, participants receiving the second intervention scored 7.6 percentage points higher (p = .02) on open-ended questions about understanding than participants in the control, although unadjusted comparisons did not reach statistical significance. Our study supports the hypothesis that patients receiving both bulleted fact sheets and a Q&A session had higher understanding compared to standard consent. Fact sheets and short structured dialog are quick to administer and easy to replicate across studies and should be tested in larger samples. © The Author(s) 2014.

Feasibility studies of Bragg probe for noninvasive carotid pulse waveform assessment

NASA Astrophysics Data System (ADS)

Leitão, Cátia; Bilro, Lúcia; Alberto, Nélia; Antunes, Paulo; Lima, Hugo; André, Paulo S.; Nogueira, Rogério; Pinto, João L.

2013-01-01

The arterial stiffness evaluation is largely reported as an independent predictor of cardiovascular diseases. The central pulse waveform can provide important data about arterial health and has been studied in patients with several pathologies, such as diabetes mellitus, coronary artery disease and hypertension. The implementation and feasibility studies of a fiber Bragg grating probe for noninvasive monitoring of the carotid pulse are described based on fiber Bragg grating technology. Assessment tests were carried out in carotids of different volunteers and it was possible to detect the carotid pulse waveform in all subjects. In one of the subjects, the sensor was also tested in terms of repeatability. Although further tests will be required for clinical investigation, the first studies suggest that the developed sensor can be a valid alternative to electromechanical tonometers.

Low level laser therapy (photobiomodulation) for the management of breast cancer-related lymphedema: an update

NASA Astrophysics Data System (ADS)

Baxter, G. David; Liu, Lizhou; Chapple, Cathy; Petrich, Simone; Anders, Juanita J.; Tumilty, Steve

2018-04-01

Breast cancer related lymphedema (BCRL) is prevalent among breast cancer survivors, and may be painful and disfiguring with associated psychological impact. Previous research shows increasing use of low level laser therapy (LLLT), now commonly referred to as photobiomodulation (PBM) therapy for managing BCRL, in countries including the United States and Australia. However, conclusions were limited by the paucity, heterogeneity, and poor quality of previous studies. LLLT (PBM) has been barely used in clinical practice in New Zealand, and no clinical studies on LLLT (PBM) for BCRL have been conducted in this country. In order to promote this potentially useful treatment modality for BCRL patients, the Laser Lymphedema Trial Team at the University of Otago conducted a program to assess the effectiveness of LLLT (PBM) in management of BCRL. The program comprises three phases including a systematic review (completed), a feasibility study (completed), and a full-scale randomized controlled trial (proposed). This current paper provides an update on the program. Based upon the systematic review, LLLT (PBM) is considered a potentially effective treatment approach for women with BCRL; the review also indicated the need for further research including exploration of the relevance of dosage and other LLLT (PBM) parameters. The feasibility study demonstrated that it is feasible to conduct a fully powered RCT to definitively test the effectiveness of the additional use of LLLT (PBM) in the management of BCRL, and 114 participants will be needed at baseline in the main study. Currently, the full-scale RCT is under preparation.

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

PubMed

Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

2014-01-01

Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol.

PubMed

Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

2015-03-01

In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article.

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.

Reduction in chemotherapy order errors with computerised physician order entry and clinical decision support systems.

PubMed

Aziz, Muhammad Tahir; Ur-Rehman, Tofeeq; Qureshi, Sadia; Bukhari, Nadeem Irfan

Medication errors in chemotherapy are frequent and lead to patient morbidity and mortality, as well as increased rates of re-admission and length of stay, and considerable extra costs. Objective: This study investigated the proposition that computerised chemotherapy ordering reduces the incidence and severity of chemotherapy protocol errors. A computerised physician order entry of chemotherapy order (C-CO) with clinical decision support system was developed in-house, including standardised chemotherapy protocol definitions, automation of pharmacy distribution, clinical checks, labeling and invoicing. A prospective study was then conducted in a C-CO versus paper based chemotherapy order (P-CO) in a 30-bed chemotherapy bay of a tertiary hospital. Both C-CO and P-CO orders, including pharmacoeconomic analysis and the severity of medication errors, were checked and validated by a clinical pharmacist. A group analysis and field trial were also conducted to assess clarity, feasibility and decision making. The C-CO was very usable in terms of its clarity and feasibility. The incidence of medication errors was significantly lower in the C-CO compared with the P-CO (10/3765 [0.26%] versus 134/5514 [2.4%]). There was also a reduction in dispensing time of chemotherapy protocols in the C-CO. The chemotherapy computerisation with clinical decision support system resulted in a significant decrease in the occurrence and severity of medication errors, improvements in chemotherapy dispensing and administration times, and reduction of chemotherapy cost.

Pregabalin versus placebo in targeting pro-nociceptive mechanisms to prevent chronic pain after whiplash injury in at-risk individuals - a feasibility study for a randomised controlled trial.

PubMed

Nikles, J; Keijzers, G; Mitchell, G; Schug, S; Ware, R; McLean, S A; Connelly, L; Gibson, S; Farrell, S F; Sterling, M

2018-01-17

Whiplash-associated disorders (WAD) are an enormous and costly burden to Australian society. Up to 50% of people who experience a whiplash injury will never fully recover. Whiplash is resistant to treatment and no early management approach has yet been shown to prevent chronic pain. The early presence of central sensitization is associated with poor recovery. Pregabalin's effects on central sensitization indicate the potential to prevent or modulate these processes after whiplash injury and to improve health outcomes, but this has not been investigated. This paper describes the protocol for a feasibility study for a randomised controlled trial of pregabalin plus evidence-based advice compared to placebo plus evidence-based advice for individuals with acute whiplash injury who are at risk of poor recovery. This double blind, placebo-controlled randomised feasibility study will examine the feasibility and potential effectiveness of pregabalin and evidence-based advice (intervention) compared to placebo and evidence-based advice (control) for individuals with acute whiplash injury at risk of poor recovery. Thirty participants (15 per group) aged 18-65 years with Grade II WAD, within 48 hours of injury and currently experiencing at least moderate pain (NRS: ≥ 5/10) will be recruited from Emergency Departments of public hospitals in Queensland, Australia. Pregabalin will be commenced at 75 mg bd and titrated up to 300 mg bd as tolerated for 4 weeks followed by 1 week of weaning. The feasibility of trial procedures will be tested, as well as the potential effect of the intervention on the outcomes. The primary outcome of neck pain intensity at 3 months from randomisation will be compared between the treatment groups using standard analysis of variance techniques. Feasibility and potential effectiveness data will inform an appropriately powered full trial, which if successful, will provide an effective and cost-effective intervention for a costly and treatment resistant condition. It will also have implications for the early management of other traumatic conditions beyond whiplash. Clinical Trials Primary Registry: Australian and New Zealand Clinical Trials Registry. ACTRN12617000059369 . Date of Registration: 11/01/2017. Primary Trial Sponsor: The University of Queensland, Brisbane QLD 4072 Australia.

Archeological Echocardiography: Digitization and Speckle Tracking Analysis of Archival Echocardiograms in the HyperGEN Study.

PubMed

Aguilar, Frank G; Selvaraj, Senthil; Martinez, Eva E; Katz, Daniel H; Beussink, Lauren; Kim, Kwang-Youn A; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R; Arnett, Donna K; Shah, Sanjiv J

2016-03-01

Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. In the NHLBI HyperGEN study (N = 2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter-/intra-observer agreement was calculated. Accuracy was evaluated in: (1) a separate second study (N = 50) comparing prospective digital strain versus post hoc analog-to-digital strain, and (2) in a third study (N = 95) comparing prospectively obtained TDI e' velocities with post hoc STE e' velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intra-observer agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post hoc STE to prospective digital STE for strain analysis. STE-derived e' velocities correlated with, but systematically underestimated, TDI e' velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β = -2.4 [95% CI -3.6, -1.2]% per 1-SD increase in fasting glucose; P < 0.001). Archeological echocardiography, the digitization and speckle tracking analysis of archival echocardiograms, is feasible and generates indices of cardiac mechanics similar to contemporary studies. © 2015, Wiley Periodicals, Inc.

Archeological Echocardiography: Digitization and Speckle-Tracking Analysis of Archival Echocardiograms in the HyperGEN Study

PubMed Central

Aguilar, Frank G.; Selvaraj, Senthil; Martinez, Eva E.; Katz, Daniel H.; Beussink, Lauren; Kim, Kwang-Youn A.; Ping, Jie; Rasmussen-Torvik, Laura; Goyal, Amita; Sha, Jin; Irvin, Marguerite R.; Arnett, Donna K.; Shah, Sanjiv J.

2015-01-01

Background Several large epidemiologic studies and clinical trials have included echocardiography, but images were stored in analog format and these studies predated tissue Doppler imaging (TDI) and speckle-tracking echocardiography (STE). We hypothesized that digitization of analog echocardiograms, with subsequent quantification of cardiac mechanics using STE, is feasible, reproducible, accurate, and produces clinically valid results. Methods In the NHLBI HyperGEN study (N=2234), archived analog echocardiograms were digitized and subsequently analyzed using STE to obtain tissue velocities/strain. Echocardiograms were assigned quality scores and inter/intraobserver agreement was calculated. Accuracy was evaluated in (1) a separate second study (N=50) comparing prospective digital strain vs. post-hoc analog-to-digital strain; and (2) in a third study (N=95) comparing prospectively-obtained TDI e′ velocities with post-hoc STE e′ velocities. Finally, we replicated previously known associations between tissue velocities/strain, conventional echocardiographic measurements, and clinical data. Results Of the 2234 HyperGEN echocardiograms, 2150 (96.2%) underwent successful digitization and STE analysis. Inter/intraobserver agreement was high for all STE parameters, especially longitudinal strain (LS). In accuracy studies, LS performed best when comparing post-hoc STE to prospective digital STE for strain analysis. STE-derived e′ velocities correlated with, but systematically underestimated, TDI e′ velocity. Several known associations between clinical variables and cardiac mechanics were replicated in HyperGEN. We also found a novel independent inverse association between fasting glucose and LS (adjusted β =−2.4 [95% CI −3.6,−1.2]% per 1-SD increase in fasting glucose; P<0.001). Conclusions Archeological echocardiography, the digitization and speckle-tracking analysis of archival echocardiograms, is feasible and generates parameters of cardiac mechanics similar to contemporary studies. PMID:26525308

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

Feasibility of a Clinical Pathway with Early Oral Intake and Discharge for Laparoscopic Gastrectomy.

PubMed

Nakagawa, M; Tomii, C; Inokuchi, M; Otsuki, S; Kojima, K

2017-12-01

Although some studies have reported the safety of early oral intake after gastrectomy, it still remains controversial. This study focused on the feasibility of a clinical pathway with early oral intake and discharge setting for exclusively laparoscopic distal gastrectomy. A clinical pathway was applied to 403 patients until December 2014. In the protocol, patients are allowed to take a sip of water and a soft diet on the first and second days after the operation, respectively, and the discharge day is set as the fifth to seventh day after the operation. Clinicopathological variables were prospectively collected, and risk factors for discharge variances were analyzed. The completion rate of the clinical pathway was 76.9%. There were five re-admissions (1.2%). The overall morbidity rate was 18% ( n = 72), and major complications (Clavien-Dindo IIIa or greater) occurred in 13 patients (3%). Complications were the causes for discharge variances in 68 cases (73%), while the attending surgeons' judgment was the cause in 25 cases (27%). On multivariate analysis, age (odds ratio = 2.23, 95% confidence interval = 1.38-3.60, p = 0.001) and operative time (odds ratio = 2.38, 95% confidence interval = 1.45-3.98, p = 0.001) were independent risk factors for discharge variances. A high completion rate of a clinical pathway with early oral intake and discharge setting for laparoscopic distal gastrectomy was achievable with an acceptably low re-admission rate. Laparoscopic distal gastrectomy is recommended as a first step for a clinical pathway with an early oral intake and discharge protocol.

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.

Planning study for Merkel cell carcinoma based on the relapse pattern.

PubMed

Hoeller, Ulrike; Schubert, Tina; Mueller, Thomas; Budach, Volker; Ghadjar, Pirus; Brenner, Winfried; Kuschke, Wolf

2017-04-01

To develop a technique for radiation (RT) of in-transit path ways (IT) in Merkel cell carcinoma. In the planning study, IT were ink-marked on the skin during sentinel lymphscintigraphy and wire-marked in planning-CT. Pre- and post-operative planning-CTs were acquired. The clinical target volume (CTV) included tumor bed plus safety margin, IT and draining nodes, the planning volume (PTV) the CTV plus 0.5-1cm margin. VMAT plans with 2-3 arcs were analyzed. A planning study was performed for five pts. including two pts. with primary tumor (PT) in head and neck, 1 pt. each with PT of elbow, forearm and upper leg respectively. Plans showed satisfactory PTV coverage: D mean 100%±0%, D 98% 92.4%±2.24%, homogeneity index (HI) 0.095±0.01, conformation number (CN) 0.84±0.01 and conformality index (CI) 0.95±0.01. The planning study confirms feasibility of highly conformal irradiation of IT pathways based on individualized target delineation. Currently, patients referred for non-metastatic MCC are encouraged to enroll in a prospective clinical study that evaluates the feasibility of radiation of IT pathways. Copyright © 2017 Elsevier B.V. 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

Identifying depression post-stroke in patients with aphasia: a systematic review of the reliability, validity and feasibility of available instruments.

PubMed

van Dijk, Mariska J; de Man-van Ginkel, Janneke M; Hafsteinsdóttir, Thóra B; Schuurmans, Marieke J

2016-08-01

To identify and critically appraise the evidence for instruments assessing depression in stroke patients with aphasia. The PubMed, CINAHL, Web of Science, Psych Info and Cochrane databases were searched from inception until May 2015. Of the 383 titles found in the search, 15 articles met the inclusion criteria and six instruments were identified: The Aphasic Depression Rating Scale, the Clinical Global Impression-Scale, the Stroke Aphasic Depression Questionnaire (four versions), the Signs of Depression Scale, the Visual Analogue Mood Scale (three versions) and the Visual Analogue Self Esteem Scale. Supporting evidence for reliability and validity was limited owing to methodological flaws in the studies influencing the ratings of methodological quality. Feasibility data were available for all instruments. Rating time of the instruments ranged from less than one minute to five minutes, two instruments required extensive training. A number of instruments to assess depressive symptoms in patients with aphasia are available. None of the instruments however, were found to be sufficiently investigated and most of the studies identified were of low methodological quality. Given the present evidence, the Stroke Aphasic Depression Questionnaire-10, the Stroke Aphasic Depression Questionnaire-H10 and the Signs of Depression Scale are the most feasible and can be recommended for clinical practice. © The Author(s) 2015.

A Feasibility Study of Quantifying Longitudinal Brain Changes in Herpes Simplex Virus (HSV) Encephalitis Using Magnetic Resonance Imaging (MRI) and Stereology.

PubMed

Defres, Sylviane; Keller, Simon S; Das, Kumar; Vidyasagar, Rishma; Parkes, Laura M; Burnside, Girvan; Griffiths, Michael; Kopelman, Michael; Roberts, Neil; Solomon, Tom

2017-01-01

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. 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. 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. 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.

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

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

T-cell receptor gene therapy: critical parameters for clinical success.

PubMed

Linnemann, Carsten; Schumacher, Ton N M; Bendle, Gavin M

2011-09-01

T-cell receptor (TCR) gene therapy aims to induce immune reactivity against tumors by introducing genes encoding a tumor-reactive TCR into patient T cells. This approach has been extensively tested in preclinical mouse models, and initial clinical trials have demonstrated the feasibility and potential of TCR gene therapy as a cancer treatment. However, data obtained from preclinical and clinical studies suggest that both the therapeutic efficacy and the safety of TCR gene therapy can be and needs to be further enhanced. This review highlights those strategies that can be followed to develop TCR gene therapy into a clinically relevant treatment option for cancer patients.

TechCare: mobile assessment and therapy for psychosis - an intervention for clients in the Early Intervention Service: A feasibility study protocol.

PubMed

Husain, Nusrat; Gire, Nadeem; Kelly, James; Duxbury, Joy; McKeown, Mick; Riley, Miv; Taylor, Christopher Dj; Taylor, Peter J; Emsley, Richard; Farooq, Saeed; Caton, Neil; Naeem, Farooq; Kingdon, David; Chaudhry, Imran

2016-01-01

Technological advances in healthcare have shown promise when delivering interventions for mental health problems such as psychosis. The aim of this project is to develop a mobile phone intervention for people with psychosis and to conduct a feasibility study of the TechCare App. The TechCare App will assess participant's symptoms and respond with a personalised guided self-help-based psychological intervention with the aim of exploring feasibility and acceptability. The project will recruit 16 service users and 8-10 health professionals from the Lancashire Care NHS Foundation Trust Early Intervention Service. In strand 1 of the study, we will invite people to discuss their experience of psychosis and give their opinions on the existing evidence-based treatment (cognitive behavioural therapy) and how the mobile app can be developed. In strand 2, we will complete a test run with a small number of participants (n = 4) to refine the mobile intervention (TechCare). Finally, in strand 3 of the study, the TechCare App will be examined in a feasibility study with 12 participants. It has been suggested that there is a need for a rapid increase in the efforts to develop the evidence base for the clinical effectiveness of digital technologies, considering mHealth research can potentially be helpful in addressing the demand on mental health services globally.

Influencing risk behavior of sexually transmitted infection clinic visitors: efficacy of a new methodology of motivational preventive counseling.

PubMed

Kuyper, Lisette; de Wit, John; Heijman, Titia; Fennema, Han; van Bergen, Jan; Vanwesenbeeck, Ine

2009-06-01

A quasi-experimental study was conducted at a Dutch sexually transmitted infection (STI) clinic to compare the effects of educational counseling and motivational interviewing (MI)-based HIV/STI counseling on determinants of condom use and partner notification at 6-month follow-up. It also examined the feasibility of MI-based counseling in a busy real-life clinic. The counseling approaches were historically compared: respondents in the control condition were recruited between April and July 2005, those in the experimental condition between September and December 2005. The study involved 428 participants. These were all high-risk clients of the STI clinic. Their mean age was 33.7 years, and 39.6% were female. The study showed that MI-based counseling had a more positive effect on self-efficacy, intentions to use condoms with casual partners, and long-term condom use with steady partners. It had no adversarial outcomes on other social cognitions or behaviors compared to educational counseling. Furthermore, MI-based counseling is experienced as a more respectful and structured way of counseling. MI-based counseling was relatively easily implemented into the current clinic procedures. In addition to the implementation of the training, neither specialized staff nor additional or longer client visits were needed. However, some nurses indicated that the new method required more personal investment and effort. Limitations of the current study are the low response rates, the high educational level of most participants, and the small sample size regarding partner notification. Nonetheless, we conclude that MI-based counseling was a more effective approach to preventive counseling compared to educational counseling and feasible in the busy real-life setting.

Remote tele-mentored ultrasound for non-physician learners using FaceTime: A feasibility study in a low-income country.

PubMed

Robertson, Thomas E; Levine, Andrea R; Verceles, Avelino C; Buchner, Jessica A; Lantry, James H; Papali, Alfred; Zubrow, Marc T; Colas, L Nathalie; Augustin, Marc E; McCurdy, Michael T

2017-08-01

Ultrasound (US) is a burgeoning diagnostic tool and is often the only available imaging modality in low- and middle-income countries (LMICs). However, bedside providers often lack training to acquire or interpret US images. We conducted a study to determine if a remote tele-intensivist could mentor geographically removed LMIC providers to obtain quality and clinically useful US images. Nine Haitian non-physician health care workers received a 20-minute training on basic US techniques. A volunteer was connected to an intensivist located in the USA via FaceTime. The intensivist remotely instructed the non-physicians to ultrasound five anatomic sites. The tele-intensivist evaluated the image quality and clinical utility of performing tele-ultrasound in a LMIC. The intensivist agreed (defined as "agree" or "strongly agree" on a five-point Likert scale) that 90% (57/63) of the FaceTime images were high quality. The intensivist felt comfortable making clinical decisions using FaceTime images 89% (56/63) of the time. Non-physicians can feasibly obtain high-quality and clinically relevant US images using video chat software in LMICs. Commercially available software can connect providers in institutions in LMICs to geographically removed intensivists at a relatively low cost and without the need for extensive training of local providers. Copyright © 2017 Elsevier Inc. All rights reserved.

Investigation of the feasibility of non-invasive optical sensors for the quantitative assessment of dehydration.

PubMed

Visser, Cobus; Kieser, Eduard; Dellimore, Kiran; van den Heever, Dawie; Smith, Johan

2017-10-01

This study explores the feasibility of prospectively assessing infant dehydration using four non-invasive, optical sensors based on the quantitative and objective measurement of various clinical markers of dehydration. The sensors were investigated to objectively and unobtrusively assess the hydration state of an infant based on the quantification of capillary refill time (CRT), skin recoil time (SRT), skin temperature profile (STP) and skin tissue hydration by means of infrared spectrometry (ISP). To evaluate the performance of the sensors a clinical study was conducted on a cohort of 10 infants (aged 6-36 months) with acute gastroenteritis. High sensitivity and specificity were exhibited by the sensors, in particular the STP and SRT sensors, when combined into a fusion regression model (sensitivity: 0.90, specificity: 0.78). The SRT and STP sensors and the fusion model all outperformed the commonly used "gold standard" clinical dehydration scales including the Gorelick scale (sensitivity: 0.56, specificity: 0.56), CDS scale (sensitivity: 1.0, specificity: 0.2) and WHO scale (sensitivity: 0.13, specificity: 0.79). These results suggest that objective and quantitative assessment of infant dehydration may be possible using the sensors investigated. However, further evaluation of the sensors on a larger sample population is needed before deploying them in a clinical setting. Copyright © 2017 IPEM. Published by Elsevier Ltd. All rights reserved.

Magnetic resonance imaging for precise radiotherapy of small laboratory animals.

PubMed

Frenzel, Thorsten; Kaul, Michael Gerhard; Ernst, Thomas Michael; Salamon, Johannes; Jäckel, Maria; Schumacher, Udo; Krüll, Andreas

2017-03-01

Radiotherapy of small laboratory animals (SLA) is often not as precisely applied as in humans. Here we describe the use of a dedicated SLA magnetic resonance imaging (MRI) scanner for precise tumor volumetry, radiotherapy treatment planning, and diagnostic imaging in order to make the experiments more accurate. Different human cancer cells were injected at the lower trunk of pfp/rag2 and SCID mice to allow for local tumor growth. Data from cross sectional MRI scans were transferred to a clinical treatment planning system (TPS) for humans. Manual palpation of the tumor size was compared with calculated tumor size of the TPS and with tumor weight at necropsy. As a feasibility study MRI based treatment plans were calculated for a clinical 6MV linear accelerator using a micro multileaf collimator (μMLC). In addition, diagnostic MRI scans were used to investigate animals which did clinical poorly during the study. MRI is superior in precise tumor volume definition whereas manual palpation underestimates their size. Cross sectional MRI allow for treatment planning so that conformal irradiation of mice with a clinical linear accelerator using a μMLC is in principle feasible. Several internal pathologies were detected during the experiment using the dedicated scanner. MRI is a key technology for precise radiotherapy of SLA. The scanning protocols provided are suited for tumor volumetry, treatment planning, and diagnostic imaging. Copyright © 2016. Published by Elsevier GmbH.

Design and Clinical Feasibility of Personal Wearable Monitor for Measurement of Activity and Environmental Exposure

PubMed Central

Ribón Fletcher, Richard; Oreskovic, Nicolas M.; Robinson, Alyssa I.

2015-01-01

Human exposure to specific environmental factors (e.g. air quality, lighting, and sound) is known to play an important role in the pathogenesis of many chronic diseases (e.g. asthma) and mental health disorders (e.g. anxiety). However, conventional fixed environmental monitoring stations are sparsely located and, despite environmental models, cannot adequately assess individual exposure levels. New forms of low-cost portable monitors have begun to emerge that enable the collection of higher spatial density “crowd sourced” data; however, the first generation of these low-cost environmental monitors have generally not been suitable for clinical environmental health studies due to practical challenges such as calibration, reproducibility, form factor, and battery life. In this paper, we present a wearable environmental monitor that overcomes these challenges and can be used in clinical studies The new device, called “Eco-Mini,” can be used without a smart phone and is capable of locally sampling and recording a variety of environmental parameters (Ozone, Sulfur Dioxide, Volatile Organic Compounds, humidity, temperature, ambient light color balance, and sound level) as well as individual activity (3-axis accelerometer) and location (GPS). In this paper, we also report findings and discuss lessons learned from a feasibility study conducted for one week with pediatric patients as part of an ongoing asthma research study. PMID:25570098

Feasibility of an online mindfulness-based program for patients with melanoma: study protocol for a randomised controlled trial.

PubMed

Russell, Lahiru; Ugalde, Anna; Milne, Donna; Krishnasamy, Meinir; O Seung Chul, Eric; Austin, David W; Chambers, Richard; Orellana, Liliana; Livingston, Patricia M

2018-04-13

People with a melanoma diagnosis are at risk of recurrence, developing a new primary or experiencing disease progression. Previous studies have suggested that fear of a cancer recurrence is clinically relevant in this group of patients and, if not addressed, can lead to distress. Mindfulness-based interventions have been shown to alleviate symptoms of anxiety and depression among various groups of cancer patients. Online mindfulness-based interventions have the potential to reach people unable to attend face-to-face interventions due to limitations such as cancer-related illness, transportation or time constraints. This study aims to (1) examine whether individuals with a melanoma diagnosis are willing to participate and adhere to a 6-week online mindfulness-based intervention and (2) explore potential benefits of the program on fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness to inform the design of a clinical trial. This is a single-site randomised controlled trial of a feasibility study. Seventy-five participants with stage 2c or 3 melanoma will be recruited from a melanoma outpatient clinic and randomised (2:1) either to an online mindfulness-based program (intervention) or to usual care (control). The intervention is a 6-week program specifically developed for this study. It consists of videos describing the concept of mindfulness, short daily guided meditation practices (5-10 min), automated meditation reminders and instructions for applying mindfulness in daily life to enhance wellbeing. All participants will complete questionnaires at baseline and at 6-week post-randomisation. Participants in the control group will be given access to the online program at the end of the study. Primary outcomes are overall recruitment; retention; extent of questionnaire completion; and usability and acceptability of, and adherence to, the program. The secondary outcomes are fear of cancer recurrence, worries, rumination, perceived stress and trait mindfulness measured using validated instruments. This feasibility study will evaluate participants' satisfaction with the program and identify barriers to recruitment and adherence. The recruitment and data collection process will highlight methodological aspects to address in the planning of a larger scale study assessing the impact of an online mindfulness-based intervention on fear of cancer recurrence and wellbeing. Australian New Zealand Clinical Trials Registry, ACTRN12617000081314 . Registered on 16 January 2017.

Feasibility of Electronic Nicotine Delivery Systems in Surgical Patients

PubMed Central

Nolan, Margaret; Leischow, Scott; Croghan, Ivana; Kadimpati, Sandeep; Hanson, Andrew; Schroeder, Darrell

2016-01-01

Abstract Introduction: Cigarette smoking is a known risk factor for postoperative complications. Quitting or cutting down on cigarettes around the time of surgery may reduce these risks. This study aimed to determine the feasibility of using electronic nicotine delivery systems (ENDS) to help patients achieve this goal, regardless of their intent to attempt long-term abstinence. Methods: An open-label observational study was performed of cigarette smoking adults scheduled for elective surgery at Mayo Clinic Rochester and seen in the pre-operative evaluation clinic between December 2014 and June 2015. Subjects were given a supply of ENDS to use prior to and 2 weeks after surgery. They were encouraged to use them whenever they craved a cigarette. Daily use of ENDS was recorded, and patients were asked about smoking behavior and ENDS use at baseline, 14 days and 30 days. Results: Of the 105 patients approached, 80 (76%) agreed to participate; five of these were later excluded. Among the 75, 67 (87%) tried ENDS during the study period. At 30-day follow-up, 34 (51%) who had used ENDS planned to continue using them. Average cigarette consumption decreased from 15.6 per person/d to 7.6 over the study period ( P < .001). At 30 days, 11/67 (17%) reported abstinence from cigarettes. Conclusion: ENDS use is feasible in adult smokers scheduled for elective surgery and is associated with a reduction in perioperative cigarette consumption. These results support further exploration of ENDS as a means to help surgical patients reduce or eliminate their cigarette consumption around the time of surgery. Implications: Smoking in the perioperative period increases patients’ risk for surgical complications and healing difficulties, but new strategies are needed to help patients quit or cut down during this stressful time. These pilot data suggest that ENDS use is feasible and well-accepted in surgical patients, and worthy of exploration as a harm reduction strategy in these patients. PMID:26834051

Evaluating rehabilitation following lumbar fusion surgery (REFS): study protocol for a randomised controlled trial.

PubMed

Greenwood, James; McGregor, Alison; Jones, Fiona; Hurley, Michael

2015-06-04

The rate of lumbar fusion surgery (LFS) is increasing. Clinical recovery often lags technical outcome. Approximately 40% of patients undergoing LFS rate themselves as symptomatically unchanged or worse following surgery. There is little research describing rehabilitation following LFS with no clear consensus as to what constitutes the optimum strategy. It is important to develop appropriate rehabilitation strategies to help patients manage pain and recover lost function following LFS. The study design is a randomised controlled feasibility trial exploring the feasibility of providing a complex multi-method rehabilitation intervention 3 months following LFS. The rehabilitation protocol that we have developed involves small participant groups of therapist led structured education utilising principles of cognitive behavioral therapy (CBT), progressive, individualised exercise and peer support. Participants will be randomly allocated to either usual care (UC) or the rehabilitation group (RG). We will recruit 50 subjects, planning to undergo LFS, over 30 months. Following LFS all participants will experience normal care for the first 3 months. Subsequent to a satisfactory 3 month surgical review they will commence their allocated post-operative treatment (RG or UC). Data collection will occur at baseline (pre-operatively), 3, 6 and 12 months post-operatively. Primary outcomes will include an assessment of feasibility factors (including recruitment and compliance). Secondary outcomes will evaluate the acceptability and characteristics of a limited cluster of quantitative measures including the Oswestry Disability Index (ODI) and an aggregated assessment of physical function (walking 50 yards, ascend/descend a flight of stairs). A nested qualitative study will evaluate participants' experiences. This study will evaluate the feasibility of providing complex, structured rehabilitation in small groups 3 months following technically successful LFS. We will identify strengths and weakness of the proposed protocol and the usefulness and characteristics of the planned outcome measures. This will help shape the development of rehabilitation strategies and inform future work aimed at evaluating clinical efficacy. ISRCTN60891364, 10/07/2014.

Could home sexually transmitted infection specimen collection with e-prescription be a cost-effective strategy for clinical trials and clinical care?

PubMed

Blake, Diane R; Spielberg, Freya; Levy, Vivian; Lensing, Shelly; Wolff, Peter A; Venkatasubramanian, Lalitha; Acevedo, Nincoshka; Padian, Nancy; Chattopadhyay, Ishita; Gaydos, Charlotte A

2015-01-01

Results of a recent demonstration project evaluating feasibility, acceptability, and cost of a Web-based sexually transmitted infection (STI) testing and e-prescription treatment program (eSTI) suggest that this approach could be a feasible alternative to clinic-based testing and treatment, but the results need to be confirmed by a randomized comparative effectiveness trial. We modeled a decision tree comparing (1) cost of eSTI screening using a home collection kit and an e-prescription for uncomplicated treatment versus (2) hypothetical costs derived from the literature for referral to standard clinic-based STI screening and treatment. Primary outcome was number of STIs detected. Analyses were conducted from the clinical trial perspective and the health care system perspective. The eSTI strategy detected 75 infections, and the clinic referral strategy detected 45 infections. Total cost of eSTI was $94,938 ($1266/STI detected) from the clinical trial perspective and $96,088 ($1281/STI detected) from the health care system perspective. Total cost of clinic referral was $87,367 ($1941/STI detected) from the clinical trial perspective and $71,668 ($1593/STI detected) from the health care system perspective. Results indicate that eSTI will likely be more cost-effective (lower cost/STI detected) than clinic-based STI screening, both in the context of clinical trials and in routine clinical care. Although our results are promising, they are based on a demonstration project and estimates from other small studies. A comparative effectiveness research trial is needed to determine actual cost and impact of the eSTI system on identification and treatment of new infections and prevention of their sequelae.

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…

Feasibility of Self-Reflection as a Tool to Balance Clinical Reasoning Strategies

ERIC Educational Resources Information Center

Sibbald, Matthew; de Bruin, Anique B. H.

2012-01-01

Clinicians are believed to use two predominant reasoning strategies: system 1 based pattern recognition, and system 2 based analytical reasoning. Balancing these cognitive reasoning strategies is widely believed to reduce diagnostic error. However, clinicians approach different problems with different reasoning strategies. This study explores…

Attention Training for School-Aged Children with ADHD: Results of an Open Trial

ERIC Educational Resources Information Center

Tamm, Leanne; Hughes, Carroll; Ames, Laure; Pickering, Joyce; Silver, Cheryl H.; Stavinoha, Peter; Castillo, Christine L.; Rintelmann, Jeanne; Moore, Jarrette; Foxwell, Aleksandra; Bolanos, S. Gina; Hines, Tabatha; Nakonezny, Paul A.; Emslie, Graham

2010-01-01

Objective: The article discusses a feasibility study conducted to examine whether Pay Attention!, an intervention training sustained, selective, alternating, and divided attention, could be utilized in a clinical setting with children diagnosed with ADHD, and whether children who received the intervention made attention and executive functioning…

Prenatal diagnosis of chromosomal abnormalities using array-based comparative genomic hybridization

USDA-ARS?s Scientific Manuscript database

This study was designed to evaluate the feasibility of using a targeted array-CGH strategy for prenatal diagnosis of genomic imbalances in a clinical setting of current pregnancies. Women undergoing prenatal diagnosis were counseled and offered array-CGH (BCM V4.0) in addition to routine chromosome ...

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…

Train-the-trainer: implementation of cognitive behavioural guided self-help for recurrent binge eating in a naturalistic setting.

PubMed

Zandberg, Laurie J; Wilson, G Terence

2013-05-01

The present study evaluated the feasibility and acceptability of cognitive behavioural guided self-help (CBTgsh) for recurrent binge eating using the train-the-trainer implementation strategy. After receiving expert-led training in CBTgsh, a master's-level graduate student in clinical psychology subsequently trained and supervised less experienced graduate students to implement the treatment in an open clinical trial. Participants were 38 treatment-seeking students at a university counselling centre with recurrent binge eating, featuring cases of bulimia nervosa, binge eating disorder, or eating disorder not otherwise specified. Intent-to-treat (ITT) analyses revealed 42.1% abstinence from binge eating at post-treatment and 47.4% at one-month follow-up. Participants reported significant pretreatment to post-treatment reductions on measures of specific eating disorder psychopathology, general psychopathology, and functional impairment and high levels of treatment acceptability. These results provide 'proof-of-concept' for the train-the-trainer implementation strategy and add to the evidence supporting the feasibility and effectiveness of CBTgsh in routine clinical care. Copyright © 2012 John Wiley & Sons, Ltd and Eating Disorders Association.

Motion tracking to enable pre-surgical margin mapping in basal cell carcinoma using optical imaging modalities: initial feasibility study using optical coherence tomography

NASA Astrophysics Data System (ADS)

Duffy, M.; Richardson, T. J.; Craythorne, E.; Mallipeddi, R.; Coleman, A. J.

2014-02-01

A system has been developed to assess the feasibility of using motion tracking to enable pre-surgical margin mapping of basal cell carcinoma (BCC) in the clinic using optical coherence tomography (OCT). This system consists of a commercial OCT imaging system (the VivoSight 1500, MDL Ltd., Orpington, UK), which has been adapted to incorporate a webcam and a single-sensor electromagnetic positional tracking module (the Flock of Birds, Ascension Technology Corp, Vermont, USA). A supporting software interface has also been developed which allows positional data to be captured and projected onto a 2D dermoscopic image in real-time. Initial results using a stationary test phantom are encouraging, with maximum errors in the projected map in the order of 1-2mm. Initial clinical results were poor due to motion artefact, despite attempts to stabilise the patient. However, the authors present several suggested modifications that are expected to reduce the effects of motion artefact and improve the overall accuracy and clinical usability of the system.

Interdisciplinary collaboration: the role of the clinical nurse leader.

PubMed

Bender, Miriam; Connelly, Cynthia D; Brown, Caroline

2013-01-01

  To explore the feasibility and acceptability of a clinical nurse leader (CNL) role to improve interdisciplinary collaboration (IC) within a fragmented acute-care microsystem.   Fragmented patient care is associated with preventable adverse healthcare outcomes. IC decreases fragmentation and improves patient care quality. The CNL role is theorized to provide the necessary leadership and competency skill base to impact IC at the optimal organizational level, the point of care where most healthcare decisions are made.   This study used a descriptive non-experimental design. CNL daily workflow was developed to target empirical determinants of IC. Descriptive data were collected from multiple stakeholders using an investigator-developed survey.   Findings indicate the integration of the role is feasible and acceptable to the microsystem healthcare team.   Preliminary evidence suggests the CNL role may be an effective intervention to facilitate IC. More research is needed to support the CNL role's association with microsystem IC.   The CNL role presents an innovative opportunity for clinical and administrative leadership to partner together to redesign a healthcare delivery system and improve patient care quality. © 2012 Blackwell Publishing Ltd.

Disability and Fatigue Can Be Objectively Measured in Multiple Sclerosis.

PubMed

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

2016-01-01

The available clinical outcome measures of disability in multiple sclerosis are not adequately responsive or sensitive. To investigate the feasibility of inertial sensor-based gait analysis in multiple sclerosis. 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. 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. Inertial sensor-based gait analysis is feasible and can detect clinical and subclinical disability in multiple sclerosis.

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.

Feasibility, safety and outcomes of playing Kinect Adventures!™ for people with Parkinson's disease: a pilot study.

PubMed

Pompeu, J E; Arduini, L A; Botelho, A R; Fonseca, M B F; Pompeu, S M A A; Torriani-Pasin, C; Deutsch, J E

2014-06-01

To assess the feasibility, safety and outcomes of playing Microsoft Kinect Adventures™ for people with Parkinson's disease in order to guide the design of a randomised clinical trial. Single-group, blinded trial. Rehabilitation Center of São Camilo University, Brazil. Seven patients (six males, one female) with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Fourteen 60-minute sessions, three times per week, playing four games of Kinect Adventures! The feasibility and safety outcomes were patients' game performance and adverse events, respectively. The clinical outcomes were the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and Parkinson's Disease Questionnaire (PDQ-39). Patients' scores for the four games showed improvement. The mean [standard deviation (SD)] scores in the first and last sessions of the Space Pop game were 151 (36) and 198 (29), respectively [mean (SD) difference 47 (7), 95% confidence interval 15 to 79]. There were no adverse events. Improvements were also seen in the 6-minute walk test, Balance Evaluation System Test, Dynamic Gait Index and PDQ-39 following training. Kinect-based training was safe and feasible for people with Parkinson's disease (Hoehn and Yahr Stages 2 and 3). Patients improved their scores for all four games. No serious adverse events occurred during training with Kinect Adventures!, which promoted improvement in activities (balance and gait), body functions (cardiopulmonary aptitude) and participation (quality of life). Copyright © 2013 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

Chimeric Antigen Receptor-Modified T Cells for Solid Tumors: Challenges and Prospects

PubMed Central

Guo, Yelei; Wang, Yao; Han, Weidong

2016-01-01

Recent studies have highlighted the successes of chimeric antigen receptor-modified T- (CART-) cell-based therapy for B-cell malignancies, and early phase clinical trials have been launched in recent years. The few published clinical studies of CART cells in solid tumors have addressed safety and feasibility, but the clinical outcome data are limited. Although antitumor effects were confirmed in vitro and in animal models, CART-cell-based therapy still faces several challenges when directed towards solid tumors, and it has been difficult to achieve the desired outcomes in clinical practice. Many studies have struggled to improve the clinical responses to and benefits of CART-cell treatment of solid tumors. In this review, the status quo of CART cells and their clinical applications for solid tumors will be summarized first. Importantly, we will suggest improvements that could increase the therapeutic effectiveness of CART cells for solid tumors and their future clinical applications. These interventions will make treatment with CART cells an effective and routine therapy for solid tumors. PMID:26998495

Towards a Formative Assessment of Classroom Competencies (FACCs) for postgraduate medical trainees.

PubMed

Gray, Christopher S; Hildreth, Anthony J; Fisher, Catherine; Brown, Andrew; Jones, Anita; Turner, Ruth; Boobis, Leslie

2008-12-17

An assumption of clinical competency is no longer acceptable or feasible in routine clinical practice. We sought to determine the feasibility, practicability and efficacy of undertaking a formal assessment of clinical competency for all postgraduate medical trainees in a large NHS foundation trust. FY1 doctors were asked to complete a questionnaire to determine prior experience and self reported confidence in performing the GMC core competencies. From this a consensus panel of key partners considered and developed an 8 station Objective Structured Clinical Examination (OSCE) circuit to assess clinical competencies in all training grade medical staff... The OSCE was then administered to all training grade doctors as part of their NHS trust induction process. 106 (87.6% of all trainees) participated in the assessment during the first 14 days of appointment. Candidates achieved high median raw percentage scores for the majority of stations however analysis of pre defined critical errors and omissions identified important areas for concern. Performance of newly qualified FY1 doctor was significantly better than other grades for the arterial blood gas estimation and nasogastric tube insertion stations. Delivering a formal classroom assessment of clinical competencies to all trainees as part of the induction process was both feasible and useful. The assessment identified areas of concern for future training and also served to reassure as to the proficiency of trainees in undertaking the majority of core competencies.

Implementation of a pediatric critical care focused bedside ultrasound training program in a large academic PICU.

PubMed

Conlon, Thomas W; Himebauch, Adam S; Fitzgerald, Julie C; Chen, Aaron E; Dean, Anthony J; Panebianco, Nova; Darge, Kassa; Cohen, Meryl S; Greeley, William J; Berg, Robert A; Nishisaki, Akira

2015-03-01

To determine the feasibility and describe the process of implementing a pediatric critical care bedside ultrasound program in a large academic PICU and to evaluate the impact of bedside ultrasound on clinical management. Retrospective case series, description of program implementation. Single-center quaternary noncardiac PICU in a children's hospital. Consecutive patients from January 22, 2012, to July 22, 2012, with bedside ultrasounds performed and interpreted by pediatric critical care practitioners. A pediatric critical care bedside ultrasound program consisting of a 2-day immersive course followed by clinical performance with internal quality assurance review was implemented. Studies performed in the PICU following training were documented and reviewed against reference standards including subspecialist-performed ultrasound or clinical response. Seventeen critical care faculties and eight fellows recorded 201 bedside ultrasound studies over 6 months in defined core applications: 57 procedural (28%), 76 hemodynamic (38%), 35 thoracic (17%), and 33 abdominal (16%). A quality assurance review identified 23 studies (16% of all nonprocedural studies) as critical (affected clinical management or gave valuable information). Forty-eight percent of those studies (11/23) were within the hemodynamic core. The proportion of critical studies were not significantly different across the applications (hemodynamic, 11/76 [15%] vs thoracic and abdominal, 12/68 [18%]; p = 0.65). Examples of critical studies include evidence of tamponade secondary to pleural effusions, identification of pulmonary hypertension, hemodynamic assessment before tracheal intubation, recognition of hypovolemia and systemic vascular resistance abnormalities, determination of pneumothorax, location of chest tube and urinary catheter, and differentiation of pleural fluid from pulmonary consolidation. Implementation of a critical care bedside ultrasound program for critical care providers in a large academic PICU is feasible. Bedside ultrasound evaluation and interpretation by intensivists affected the management of critically ill children.

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

Two-week virtual reality training for dementia: Single case feasibility study.

PubMed

McEwen, Daniel; Taillon-Hobson, Anne; Bilodeau, Martin; Sveistrup, Heidi; Finestone, Hillel

2014-01-01

Persons with dementia (PWD) are known to have difficulty with participation and focus during physical activity. Virtual reality (VR) offers a unique medium for motor learning but has only been used previously for cognitive assessment for PWD. Our study had two objectives: (1) investigate the feasibility and safety of an exercise-based VR training program in PWD, and (2) investigate its effects on balance and mobility. The intervention consisted of daily (5 d/wk, 1 h each) VR training sessions for 2 wk for a single research participant. Clinical balance and mobility measures were assessed 1 wk prior to, during, 1 wk following, and 1 mo after the intervention. Postintervention interviews provided qualitative feedback from the participant and his caregivers. Results indicate that VR training is feasible, safe, and enjoyable for PWD. However, balance and mobility measures were unaffected. VR training is well tolerated in a single research participant with dementia and is an engaging medium for participation in exercise.

Efficacy of a novel swallowing exercise program for chronic dysphagia in long-term head and neck cancer survivors.

PubMed

Kraaijenga, Sophie A C; Molen, Lisette van der; Stuiver, Martijn M; Takes, Robert P; Al-Mamgani, Abrahim; Brekel, Michiel W M van den; Hilgers, Frans J M

2017-10-01

The efficacy of rehabilitative exercises for chronic dysphagia treatment in head and neck cancer survivors has not been studied extensively and is ambiguous. A prospective clinical phase II study using an intensive strength training program was carried out in 17 head and neck cancer survivors with chronic dysphagia. Both swallow and nonswallow exercises were performed for 6-8 weeks with a newly developed tool allowing for progressive muscle overload, including chin tuck, jaw opening, and effortful swallow exercises. Outcome parameters were feasibility, compliance, and parameters for effect. Feasibility in terms of the program completion rate was 88%. Compliance with the exercises was 97%. After the training period, chin tuck, jaw opening, and anterior tongue strength had substantially improved. All but 1 patient reported to benefit from the exercises. Feasibility and compliance were high. Some objective and subjective effects of progressive load on muscle strength and swallowing function could be demonstrated. © 2017 Wiley Periodicals, Inc.

Feasibility of a Customized, In-Home, Game-Based Stroke Exercise Program Using the Microsoft Kinect® Sensor

PubMed Central

PROFFITT, RACHEL; LANGE, BELINDA

2015-01-01

The objective of this study was to determine the feasibility of a 6-week, game-based, in-home telerehabilitation exercise program using the Microsoft Kinect® for individuals with chronic stroke. Four participants with chronic stroke completed the intervention based on games designed with the customized Mystic Isle software. The games were tailored to each participant’s specific rehabilitation needs to facilitate the attainment of individualized goals determined through the Canadian Occupational Performance Measure. Likert scale questionnaires assessed the feasibility and utility of the game-based intervention. Supplementary clinical outcome data were collected. All participants played the games with moderately high enjoyment. Participant feedback helped identify barriers to use (especially, limited free time) and possible improvements. An in-home, customized, virtual reality game intervention to provide rehabilitative exercises for persons with chronic stroke is practicable. However, future studies are necessary to determine the intervention’s impact on participant function, activity, and involvement. PMID:27563384

Feasibility of noninvasive fetal electrocardiographic monitoring in a clinical setting.

PubMed

Arya, Bhawna; Govindan, Rathinaswamy; Krishnan, Anita; Duplessis, Adre; Donofrio, Mary T

2015-06-01

Cardiac rhythm is an essential component of fetal cardiac evaluation. The Monica AN24 is a fetal heart rate monitor that may provide a quick, inexpensive modality for obtaining a noninvasive fetal electrocardiogram (fECG) in a clinical setting. The fECG device has the ability to acquire fECG signals and allow calculation of fetal cardiac time intervals between 16- and 42-week gestational age (GA). We aimed to demonstrate the feasibility of fECG acquisition in a busy fetal cardiology clinic using the Monica fetal heart rate monitor. This is a prospective observational pilot study of fECG acquired from fetuses referred for fetal echocardiography. Recordings were performed for 5-15 min. Maternal signals were attenuated and fECG averaged. fECG and fetal cardiac time intervals (PR, QRS, RR, and QT) were evaluated by two cardiologists independently and inter-observer reliability was assessed using intraclass coefficient (ICC). Sixty fECGs were collected from 50 mothers (mean GA 28.1 ± 6.1). Adequate signal-averaged waveforms were obtained in 20 studies with 259 cardiac cycles. Waveforms could not be obtained between 26 and 30 weeks. Fetal cardiac time intervals were measured and were reproducible for PR (ICC = 0.89; CI 0.77-0.94), QRS (ICC = 0.79; CI 0.51-0.91), and RR (ICC = 0.77; CI 0.53-0.88). QT ICC was poor due to suboptimal T-wave tracings. Acquisition of fECG and measurement of fetal cardiac time intervals is feasible in a clinical setting between 19- and 42-week GA, though tracings are difficult to obtain, especially between 26 and 30 weeks. There was high reliability in fetal cardiac time intervals measurements, except for QT. The device may be useful for assessing atrioventricular/intraventricular conduction in fetuses from 20 to 26 and >30 weeks. Techniques to improve signal acquisition, namely T-wave amplification, are ongoing.

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.

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

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

2017-06-01

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

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

PubMed Central

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

2016-01-01

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

Phase II multi-institutional clinical trial on a new mixed beam RT scheme of IMRT on pelvis combined with a carbon ion boost for high-risk prostate cancer patients.

PubMed

Marvaso, Giulia; Jereczek-Fossa, Barbara A; Vischioni, Barbara; Ciardo, Delia; Giandini, Tommaso; Hasegawa, Azusa; Cattani, Federica; Carrara, Mauro; Ciocca, Mario; Bedini, Nice; Villa, Sergio; Morlino, Sara; Russo, Stefania; Zerini, Dario; Colangione, Sarah Pia; Panaino, Costanza Maria Vittoria; Fodor, Cristiana; Santoro, Luigi; Pignoli, Emanuele; Valvo, Francesca; Valdagni, Riccardo; De Cobelli, Ottavio; Orecchia, Roberto

2017-05-12

Definition of the optimal treatment schedule for high-risk prostate cancer is under debate. A combination of photon intensity modulated radiotherapy (IMRT) on pelvis with a carbon ion boost might be the optimal treatment scheme to escalate the dose on prostate and deliver curative dose with respect to normal tissue and quality of dose distributions. In fact, carbon ion beams offer the advantage to deliver hypofractionated radiotherapy (RT) using a significantly smaller number of fractions compared to conventional RT without increasing risks of late effects. This study is a prospective phase II clinical trial exploring safety and feasibility of a mixed beam scheme of carbon ion prostate boost followed by photon IMRT on pelvis. The study is designed to enroll 65 patients with localized high-risk prostate cancer at 3 different oncologic hospitals: Istituto Europeo di Oncologia, Fondazione IRCCS Istituto Nazionale dei Tumori, and Centro Nazionale di Adroterapia Oncologica. The primary endpoint is the evaluation of safety and feasibility with acute toxicity scored up to 1 month after the end of RT. Secondary endpoints are treatment early (3 months after the end of RT) and long-term tolerability, quality of life, and efficacy. The study is not yet recruiting; in silico studies are ongoing and we expect to start recruitment by 2017. The present clinical trial aims at improving the current treatment for high-risk prostate cancer, evaluating safety and feasibility of a new RT mixed-beam scheme including photons and carbon ions. Encouraging results are coming from carbon ion facilities worldwide on the treatment of different tumors including prostate cancers. Carbon ions combine physical properties allowing for high dose conformity and advantageous radiobiological characteristics. The proposed mixed beam treatment has the advantage to combine a photon high conformity standard of care IMRT phase with a hypofractionated carbon ion RT boost delivered in a short overall treatment time.

Is it feasible to discuss an advance directive with a Chinese patient with advanced malignancy? A prospective cohort study.

PubMed

Wong, S Y; Lo, S H; Chan, C H; Chui, H S; Sze, W K; Tung, Y

2012-06-01

Advance directives have been implemented for years in western countries, but the concept is new to Asian cultures. According to traditional Chinese culture, family members usually play a decisive role in a patient's treatment plan. Thus it may be hard to implement an advance directive despite its importance to the treatment of patients. The objectives of this study were to assess the feasibility of advance directive engagement and to explore significant contributing factors to achieving such a goal. Prospective cohort study. Palliative Care Unit of Clinical Oncology, Tuen Mun Hospital, Hong Kong. The subjects of the investigation were adult patients diagnosed to have advanced malignancy and newly referred to the hospice service from 24 April 2009 to 30 July 2009. Data were collected from nursing assessment forms, locally designed advance directive forms, a checklist completed by oncologists, and details available in the electronic hospital record. Of the 191 eligible patients, 120 (63%) had the advance directive, whereas 71 (37%) did not. In the Cox regression model, the patient having insight of a poor prognosis was the most significant factor facilitating advance directive engagement (P=0.001). Any family objection in the discussion of advance directives was also an important factor, though it did not reach statistical significance (P=0.082). Other factors like age, gender, education, religion, financial status, living environment, understanding the diagnosis, bereavement experience, type of cancer, nature of illness, courses of chemotherapy or radiotherapy received, main caregiver, in-house supporter, nurse-led clinic attendance, clinical psychologist consultation, and in-patient hospice nurse coordinator interview were all statistically insignificant. Our study demonstrated that it was feasible to discuss an advance directive with Chinese patients with advanced malignancy. When patients have insight about their poor prognosis and family members have no objection, it may be appropriate to discuss an advance directive.

Tailoring International Pressure Ulcer Prevention Guidelines for Nigeria: A Knowledge Translation Study Protocol.

PubMed

Ilesanmi, Rose Ekama; Gillespie, Brigid M; Adejumo, Prisca Olabisi; Chaboyer, Wendy

2015-07-28

The 2014 International Pressure Ulcer Prevention (PUP) Clinical Practice Guidelines (CPG) provides the most current evidence based strategies to prevent Pressure Ulcer (PU). The evidence upon which these guidelines have been developed has predominantly been generated from research conducted in developed countries. Some of these guidelines may not be feasible in developing countries due to structural and resource issues; therefore there is a need to adapt these guidelines to the context thus making it culturally acceptable. To present a protocol detailing the tailoring of international PUPCPG into a care bundle for the Nigerian context. Guided by the Knowledge to Action (KTA) framework, a two phased study will be undertaken. In Phase 1, the Delphi technique with stakeholder leaders will be used to review the current PUPCPG, identifying core strategies that are feasible to be adopted in Nigeria. These core strategies will become components of a PUP care bundle. In Phase 2, key stakeholder interviews will be used to identify the barriers, facilitators and potential implementation strategies to promote uptake of the PUP care bundle. A PUP care bundle, with three to eight components is expected to be developed from Phase 1. Implementation strategies to promote adoption of the PUP care bundle into clinical practice in selected Nigerian hospitals, is expected to result from Phase 2. Engagement of key stakeholders and consumers in the project should promote successful implementation and translate into better patient care. Using KTA, a knowledge translation framework, to guide the implementation of PUPCPG will enhance the likelihood of successful adoption in clinical practice. In implementing a PUP care bundle, developing countries face a number of challenges such as the feasibility of its components and the required resources.

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

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

DTIC Science & Technology

2015-10-01

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

JPRS Report, Science & Technology, Europe & Latin America.

DTIC Science & Technology

1988-01-21

this way we can analyze the elements that control the 27 cell-specific and temporal expression of genes, and study the effects of genie expression... effects of new genetic diversity that a scientific basis will be created for the establishment of efficient regulation. 5) Feasibility studies for...which I am involved inatituted a multi- centric study to evaluate the real clinical applicability and diagnostic effectiveness of associating

The use of smartphones to influence lifestyle changes in overweight and obese youth with congenital heart disease: a single-arm study: Pilot and feasibility study protocol: Smart Heart Trial.

PubMed

Rombeek, Meghan; De Jesus, Stefanie; Altamirano-Diaz, Luis; Welisch, Eva; Prapavessis, Harry; Seabrook, Jamie A; Norozi, Kambiz

2017-01-01

Both obesity and congenital heart disease (CHD) are risk factors for the long-term cardiovascular health of children and adolescents. The addition of smart mobile technology to conventional lifestyle counseling for weight management offers great potential to appeal to technologically literate youth and can address a large geographical area with minimal burden to participants. This pilot study seeks to examine the influence of a 1-year lifestyle intervention on nutrition and physical activity-related health outcomes in overweight or obese children and adolescents with CHD. This is a pilot and feasibility study which utilizes a single-arm, prospective design with a goal to recruit 40 overweight and obese patients. The feasibility metrics will evaluate the integrity of the study protocol, data collection and questionnaires, recruitment and consent, and acceptability of the intervention protocol and primary outcome measures. The primary clinical outcome metrics are anthropometry, body composition, and cardiorespiratory exercise capacity. The secondary clinical metrics include quality of life, nutrition and physical activity behavior, lung and muscle function, and cardio-metabolic risk factors. Outcomes are assessed at baseline, 6 months, and 1 year. To date, a total of 36 children and youth (11 girls), aged 7-17 years (mean = 14.4 years), have commenced the intervention. Recruitment for the study was initiated in June 2012 and is currently ongoing. The information provided in this paper is intended to help researchers and health professionals with the development and evaluation of similar lifestyle intervention programs. Since the application of smartphones to pediatric cardiac health and obesity management is a novel approach, and continued research in this area is warranted, this paper may serve as a foundation for further exploration of this health frontier and inform the development of a broader strategy for obesity management in pediatric cardiology. This pilot study was retrospectively registered at the www.ClinicalTrials.gov registry as NCT02980393 in November 2016, with the study commencing in May 2012. Study protocol version 15OCT2014.

MO-FG-CAMPUS-JeP3-04: Feasibility Study of Real-Time Ultrasound Monitoring for Abdominal Stereotactic Body Radiation Therapy

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

Su, Lin; Kien Ng, Sook; Zhang, Ying

Purpose: Ultrasound is ideal for real-time monitoring in radiotherapy with high soft tissue contrast, non-ionization, portability, and cost effectiveness. Few studies investigated clinical application of real-time ultrasound monitoring for abdominal stereotactic body radiation therapy (SBRT). This study aims to demonstrate the feasibility of real-time monitoring of 3D target motion using 4D ultrasound. Methods: An ultrasound probe holding system was designed to allow clinician to freely move and lock ultrasound probe. For phantom study, an abdominal ultrasound phantom was secured on a 2D programmable respiratory motion stage. One side of the stage was elevated than another side to generate 3D motion.more » The motion stage made periodic breath-hold movement. Phantom movement tracked by infrared camera was considered as ground truth. For volunteer study three healthy subjects underwent the same setup for abdominal SBRT with active breath control (ABC). 4D ultrasound B-mode images were acquired for both phantom and volunteers for real-time monitoring. 10 breath-hold cycles were monitored for each experiment. For phantom, the target motion tracked by ultrasound was compared with motion tracked by infrared camera. For healthy volunteers, the reproducibility of ABC breath-hold was evaluated. Results: Volunteer study showed the ultrasound system fitted well to the clinical SBRT setup. The reproducibility for 10 breath-holds is less than 2 mm in three directions for all three volunteers. For phantom study the motion between inspiration and expiration captured by camera (ground truth) is 2.35±0.02 mm, 1.28±0.04 mm, 8.85±0.03 mm in LR, AP, SI directly, respectively. The motion monitored by ultrasound is 2.21±0.07 mm, 1.32±0.12mm, 9.10±0.08mm, respectively. The motion monitoring error in any direction is less than 0.5 mm. Conclusion: The volunteer study proved the clinical feasibility of real-time ultrasound monitoring for abdominal SBRT. The phantom and volunteer ABC studies demonstrated sub-millimeter accuracy of 3D motion movement monitoring.« less

Advanced devices for photoacoustic imaging to improve cancer and cerebrovascular medicine

NASA Astrophysics Data System (ADS)

Montilla Marien, Leonardo Gabriel

Recent clinical studies have demonstrated that photoacoustic imaging (PAI) provides important diagnostic information for breast cancer staging. Despite these promising studies, PAI remains an unfeasible option for clinics due to the cost to implement, the required large modification in user conduct and the inflexibility of the hardware to accommodate other applications for the incremental enhancement in diagnostic information. The research described in this dissertation addresses these issues by designing attachments to clinical ultrasound probes and incorporating custom detectors into commercial ultrasound scanners. The ultimate benefit of these handheld devices is to expand the capability of current ultrasound systems and facilitate the translation of PAI to enhance cancer diagnostics and neurosurgical outcomes. Photoacoustic enabling devices (PEDs) were designed as attachments to two clinical ultrasound probes optimized for breast cancer diagnostics. PAI uses pulsed laser excitation to create transient heating (<1°C) and thermoelastic expansion that is detected as an ultrasonic emission. These ultrasonic emissions are remotely sensed to construct noninvasive images with optical contrast at depths much greater than other optical modalities. The PEDs are feasible in terms of cost, user familiarity and flexibility for various applications. Another possible application for PAI is in assisting neurosurgeons treating aneurysms. Aneurysms are often treated by placing a clip to prevent blood flow into the aneurysm. However, this procedure has risks associated with damaging nearby vessels. One of the developed PEDs demonstrated the feasibility to three-dimensionally image tiny microvasculature (<0.3mm) beyond large blood occlusions (>2.4mm) in a phantom model. The capability to use this during surgery would suggest decreasing the risks associated with these treatments. However, clinical ultrasound arrays are not clinically feasible for microsurgical applications due to their bulky size and linear scanning requirements for 3D. Therefore, capacitive micromachined ultrasound transducer (CMUT) two-dimensional arrays compatible with standard ultrasound scanners were used to generate real-time 3D photoacoustic images. Future probes, designed incorporating CMUT arrays, would be relatively simple to fabricate and a convenient upgrade to existing clinical ultrasound equipment. Eventually, a handheld tool with the ability to visualize, in real-time 3D, the desired microvasculature, would assist surgical procedures. The potential implications of PAI devices compatible with standard ultrasound equipment would be a streamlined cost efficient solution for translating photoacoustics into clinical practice. The practitioner could then explore the benefits of the enhanced contrast adjunctive to current ultrasound applications. Clinical availability of PAI could enhance breast cancer diagnostics and cerebrovascular surgical outcomes.

Study of user experience of an objective test (QbTest) to aid ADHD assessment and medication management: a multi-methods approach.

PubMed

Hall, Charlotte L; Valentine, Althea Z; Walker, Gemma M; Ball, Harriet M; Cogger, Heather; Daley, David; Groom, Madeleine J; Sayal, Kapil; Hollis, Chris

2017-02-10

The diagnosis and monitoring of Attention deficit hyperactivity disorder (ADHD) typically relies on subjective reports and observations. Objective continuous performance tests (CPTs) have been incorporated into some services to support clinical decision making. However, the feasibility and acceptability of adding such a test into routine practice is unknown. The study aimed to investigate the feasibility and acceptability of adding an objective computerised test to the routine assessment and monitoring of attention deficit hyperactivity disorder (ADHD). Semi-structured interviews were conducted with clinicians (n = 10) and families (parents/young people, n = 20) who participated in a randomised controlled trial. Additionally, the same clinicians (n = 10) and families (n = 76) completed a survey assessing their experience of the QbTest. The study took place in child and adolescent mental health and community paediatric clinics across the UK. Interview transcripts were thematically analysed. Interviewed clinicians and families valued the QbTest for providing an objective, valid assessment of symptoms. The QbTest was noted to facilitate communication between clinicians, families and schools. However, whereas clinicians were more unanimous on the usefulness of the QbTest, survey findings showed that, although the majority of families found the test useful, less than half felt the QbTest helped them understand the clinician's decision making around diagnosis and medication. The QbTest was seen as a potentially valuable tool to use early in the assessment process to streamline the care pathway. Although clinicians were conscious of the additional costs, these could be offset by reductions in time to diagnosis and the delivery of the test by a Healthcare Assistant. The findings indicate the QbTest is an acceptable and feasible tool to implement in routine clinical settings. Clinicians should be mindful to discuss the QbTest results with families to enable their understanding and engagement with the process. Further findings from definitive trials are required to understand the cost/benefit; however, the findings from this study support the feasibility and acceptability of integrating QbTest in the ADHD care pathway. The findings form the implementation component of the Assessing QbTest Utility in ADHD (AQUA) Trial which is registered with the ISRCTN registry ( ISRCTN11727351 , retrospectively registered 04 July 2016) and clinicaltrials.gov ( NCT02209116 , registered 04 August 2014).

Development and pilot evaluation of a clinic-based mHealth app referral service to support adult cancer survivors increase their participation in physical activity using publicly available mobile apps.

PubMed

Short, Camille E; Finlay, Amy; Sanders, Ilea; Maher, Carol

2018-01-16

Participation in regular physical activity holds key benefits for cancer survivors, yet few cancer survivors meet physical activity recommendations. This study aimed to develop and pilot test a mHealth app referral service aimed at assisting cancer survivors to increase their physical activity. In particular, the study sought to examine feasibility and acceptability of the service and determine preliminary efficacy for physical activity behaviour change. A systematic search identified potentially appropriate Apple (iOS) and Android mHealth apps. The apps were audited regarding the type of physical activity encouraged, evidence-based behavioural strategies and other characteristics, to help match apps to users' preferences and characteristics. A structured service was devised to deliver the apps and counselling, comprising two face-to-face appointments with a mid-week phone or email check-up. The mHealth app referral service was piloted using a pre-post design among 12 cancer survivors. Participants' feedback regarding the service's feasibility and acceptability was sought via purpose-designed questionnaire, and analysed using inductive thematic analysis and descriptive statistics. Change in physical activity was assessed using a valid and reliable self-report tool and analysed using paired t-tests. In line with recommendations for pilot studies, confidence intervals and effect sizes were reported to aid interpretation of clinical significance, with an alpha of 0.2 used to denote statistical significance. Of 374 mHealth apps identified during the systematic search, 54 progressed to the audit (iOS = 27, Android = 27). The apps consistently scored well for aesthetics, engagement and functionality, and inconsistently for gamification, social and behaviour change features. Ten participants completed the pilot evaluation and provided positive feedback regarding the service's acceptability and feasibility. On average, participants increased their moderate-vigorous physical activity by 236 min per week (d = 0.73; 95% CI = -49 to 522; p = 0.09). This study offered initial evidence that a mHealth app referral service for cancer survivors is feasible and acceptable and may increase physical activity levels. The large increase in physical activity is promising, but should be interpreted with caution given the small sample size and lack of control group. Further research is warranted on a larger scale to investigate generalisability, long-term compliance and application in clinical settings.

Home medication support for childhood cancer: family-centered design and testing.

PubMed

Walsh, Kathleen E; Biggins, Colleen; Blasko, Deb; Christiansen, Steven M; Fischer, Shira H; Keuker, Christopher; Klugman, Robert; Mazor, Kathleen M

2014-11-01

Errors in the use of medications at home by children with cancer are common, and interventions to support correct use are needed. We sought to (1) engage stakeholders in the design and development of an intervention to prevent errors in home medication use, and (2) evaluate the acceptability and usefulness of the intervention. We convened a multidisciplinary team of parents, clinicians, technology experts, and researchers to develop an intervention using a two-step user-centered design process. First, parents and oncologists provided input on the design. Second, a parent panel and two oncology nurses refined draft materials. In a feasibility study, we used questionnaires to assess usefulness and acceptability. Medication error rates were assessed via monthly telephone interviews with parents. We successfully partnered with parents, clinicians, and IT experts to develop Home Medication Support (HoMeS), a family-centered Web-based intervention. HoMeS includes a medication calendar with decision support, a communication tool, adverse effect information, a metric conversion chart, and other information. The 15 families in the feasibility study gave HoMeS high ratings for acceptability and usefulness. Half recorded information on the calendar to indicate to other caregivers that doses were given; 34% brought it to the clinic to communicate with their clinician about home medication use. There was no change in the rate of medication errors in this feasibility study. We created and tested a stakeholder-designed, Web-based intervention to support home chemotherapy use, which parents rated highly. This tool may prevent serious medication errors in a larger study. Copyright © 2014 by American Society of Clinical Oncology.

Development, evaluation and implementation of video-EEG telemetry at home.

PubMed

Brunnhuber, Franz; Amin, Devyani; Nguyen, Yan; Goyal, Sushma; Richardson, Mark P

2014-05-01

To describe the development and implementation of video EEG telemetry (VT) in the patient's home (home video telemetry, HVT) in a single centre. HVT met the UK Medical Research Council definition of a complex intervention, and we used its guidance to evaluate the process of piloting, evaluating, developing and implementing this new clinical service. The first phase was a feasibility study, comparing inpatient VT (IVT) with HVT in a test-retest design (n=5), to assess data quality and yield of clinically relevant events. The second phase was a pre-implementation study (n=8), to examine acceptability and satisfaction as well as the costs of IVT and HVT. Subsequently, we implemented the service, and reviewed the outcomes of the first 34 patients. The feasibility study found no difference in the quality of recording or clinical yield between IVT and HVT. The pre-implementation study showed excellent patient satisfaction. We also discuss the findings of the main stakeholder survey (consultants and technicians). Our economic modelling demonstrates a clear financial superiority of HVT over IVT. Our findings show that diagnostic HVT for seizure classification and polysomnographies can be carried out safely in the patients' home and poses no security risks for staff. HVT can be effectively integrated into an existing tertiary care service as a routine home or community-based procedure. We hope to encourage other clinical neurophysiology departments and epilepsy centres to take advantage of our experience and consider adopting and implementing HVT, with the aim of a nationwide coverage. Copyright © 2014 British Epilepsy Association. Published by Elsevier Ltd. All rights reserved.

Effect of chiropractic manipulation on vertical jump height in young female athletes with talocrural joint dysfunction: a single-blind randomized clinical pilot trial.

PubMed

Hedlund, Sofia; Nilsson, Hans; Lenz, Markus; Sundberg, Tobias

2014-02-01

The main objective of this pilot study was to explore the effect of chiropractic high-velocity, low-amplitude (HVLA) manipulation on vertical jump height in young female athletes with talocrural joint dysfunction. This was a randomized assessor-blind clinical pilot trial. Twenty-two female handball players with talocrural joint dysfunction were randomized to receive either HVLA manipulation (n = 11) or sham treatment (n = 11) once a week during a 3-week period. The main outcome was change in vertical jump height from baseline to follow-up within and between groups after 3 weeks. Nineteen athletes completed the study. After 3 weeks, the group receiving HVLA manipulation (n = 11) had a statistically significant mean (SD) improvement in vertical jump height of 1.07 (1.23) cm (P = .017). The sham treatment group (n = 8) improved their vertical jump height by 0.59 (2.03) cm (P = .436). The between groups' change was 0.47 cm (95% confidence interval, -1.31 to 2.26; P = .571) in favor of the group receiving HVLA manipulation. Blinding and sham procedures were feasible, and there were no reported adverse events. The results of this pilot study show that a larger-scale study is feasible. Preliminary results suggest that chiropractic HVLA manipulation may increase vertical jump height in young female athletes with talocrural joint dysfunction. However, the clinical result in favor of HVLA manipulation compared with sham treatment needs statistical confirmation in a larger randomized clinical trial. Copyright © 2014 National University of Health Sciences. Published by Mosby, Inc. All rights reserved.

Clinical Uncertainties, Health Service Challenges, and Ethical Complexities of HIV “Test-and-Treat”: A Systematic Review

PubMed Central

Shah, Kavita R.; Sarma, Karthik V.; Mahajan, Anish P.

2013-01-01

Despite the HIV “test-and-treat” strategy’s promise, questions about its clinical rationale, operational feasibility, and ethical appropriateness have led to vigorous debate in the global HIV community. We performed a systematic review of the literature published between January 2009 and May 2012 using PubMed, SCOPUS, Global Health, Web of Science, BIOSIS, Cochrane CENTRAL, EBSCO Africa-Wide Information, and EBSCO CINAHL Plus databases to summarize clinical uncertainties, health service challenges, and ethical complexities that may affect the test-and-treat strategy’s success. A thoughtful approach to research and implementation to address clinical and health service questions and meaningful community engagement regarding ethical complexities may bring us closer to safe, feasible, and effective test-and-treat implementation. PMID:23597344

A meta-model for computer executable dynamic clinical safety checklists.

PubMed

Nan, Shan; Van Gorp, Pieter; Lu, Xudong; Kaymak, Uzay; Korsten, Hendrikus; Vdovjak, Richard; Duan, Huilong

2017-12-12

Safety checklist is a type of cognitive tool enforcing short term memory of medical workers with the purpose of reducing medical errors caused by overlook and ignorance. To facilitate the daily use of safety checklists, computerized systems embedded in the clinical workflow and adapted to patient-context are increasingly developed. However, the current hard-coded approach of implementing checklists in these systems increase the cognitive efforts of clinical experts and coding efforts for informaticists. This is due to the lack of a formal representation format that is both understandable by clinical experts and executable by computer programs. We developed a dynamic checklist meta-model with a three-step approach. Dynamic checklist modeling requirements were extracted by performing a domain analysis. Then, existing modeling approaches and tools were investigated with the purpose of reusing these languages. Finally, the meta-model was developed by eliciting domain concepts and their hierarchies. The feasibility of using the meta-model was validated by two case studies. The meta-model was mapped to specific modeling languages according to the requirements of hospitals. Using the proposed meta-model, a comprehensive coronary artery bypass graft peri-operative checklist set and a percutaneous coronary intervention peri-operative checklist set have been developed in a Dutch hospital and a Chinese hospital, respectively. The result shows that it is feasible to use the meta-model to facilitate the modeling and execution of dynamic checklists. We proposed a novel meta-model for the dynamic checklist with the purpose of facilitating creating dynamic checklists. The meta-model is a framework of reusing existing modeling languages and tools to model dynamic checklists. The feasibility of using the meta-model is validated by implementing a use case in the system.

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

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.

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

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.

A Querying Method over RDF-ized Health Level Seven v2.5 Messages Using Life Science Knowledge Resources.

PubMed

Kawazoe, Yoshimasa; Imai, Takeshi; Ohe, Kazuhiko

2016-04-05

Health level seven version 2.5 (HL7 v2.5) is a widespread messaging standard for information exchange between clinical information systems. By applying Semantic Web technologies for handling HL7 v2.5 messages, it is possible to integrate large-scale clinical data with life science knowledge resources. Showing feasibility of a querying method over large-scale resource description framework (RDF)-ized HL7 v2.5 messages using publicly available drug databases. We developed a method to convert HL7 v2.5 messages into the RDF. We also converted five kinds of drug databases into RDF and provided explicit links between the corresponding items among them. With those linked drug data, we then developed a method for query expansion to search the clinical data using semantic information on drug classes along with four types of temporal patterns. For evaluation purpose, medication orders and laboratory test results for a 3-year period at the University of Tokyo Hospital were used, and the query execution times were measured. Approximately 650 million RDF triples for medication orders and 790 million RDF triples for laboratory test results were converted. Taking three types of query in use cases for detecting adverse events of drugs as an example, we confirmed these queries were represented in SPARQL Protocol and RDF Query Language (SPARQL) using our methods and comparison with conventional query expressions were performed. The measurement results confirm that the query time is feasible and increases logarithmically or linearly with the amount of data and without diverging. The proposed methods enabled query expressions that separate knowledge resources and clinical data, thereby suggesting the feasibility for improving the usability of clinical data by enhancing the knowledge resources. We also demonstrate that when HL7 v2.5 messages are automatically converted into RDF, searches are still possible through SPARQL without modifying the structure. As such, the proposed method benefits not only our hospitals, but also numerous hospitals that handle HL7 v2.5 messages. Our approach highlights a potential of large-scale data federation techniques to retrieve clinical information, which could be applied as applications of clinical intelligence to improve clinical practices, such as adverse drug event monitoring and cohort selection for a clinical study as well as discovering new knowledge from clinical information.

Therapist Perspectives on Training in a Package of Evidence-Based Practice Strategies for Children with Autism Spectrum Disorders Served in Community Mental Health Clinics

PubMed Central

Drahota, Amy; Stadnick, Nicole; Brookman-Frazee, Lauren

2012-01-01

Therapist perspectives regarding delivery of evidence-based practice (EBP) strategies are needed to understand the feasibility of implementation in routine service settings. This qualitative study examined the perspectives of 13 therapists receiving training and delivering a package of EBPs to children with autism spectrum disorders (ASD) in community mental health clinics. Therapists perceived the training and intervention delivery as effective at improving their clinical skills, the psychotherapy process, and child and family outcomes. Results expand parent pilot study findings, and add to the literature on training community providers and limited research on training providers to deliver EBPs to children with ASD. PMID:23086499