Voluntariness of consent to HIV clinical research: A conceptual and empirical pilot study.

PubMed

Mamotte, Nicole; Wassenaar, Douglas

2017-09-01

Obtaining voluntary informed consent for research participation is an ethical imperative, yet there appears to be little consensus regarding what constitutes a voluntary consent decision. An instrument to assess influences on participants' consent decision and perceived voluntariness was developed and piloted in two South African HIV clinical trials. The pilot study found high levels of perceived voluntariness. The feeling of having no choice but to participate was significantly associated with lower perceived voluntariness. Overall the data suggest that it is possible to obtain voluntary and valid consent for research participants in ethically complex HIV clinical trials in a developing country context.

Cleveland Clinic Rehabilitation Research Program

DTIC Science & Technology

2014-10-01

risks have been identified that would require a new risk analysis. The study is now registered as a pilot clinical trial. Use of tDCS , TMS and structural...using behavioral recording and electroencephalographic ( EEG ) recording and results were published. Study 2: The motor cortex (M1) and the...four pilot projects. Study 1: Magnetic stimulation and epilepsy In this study, transcranial magnetic stimulation ( TMS ) will be tested for its

Laparoscopic Surgical Treatment of Severe Obesity Combined with Gastroesophageal Reflux Disease: A Pilot Randomized Two-Arm Controlled Clinical Study

ERIC Educational Resources Information Center

Ospanov, Oral B.; Orekeshova, Akzhunis M.; Fursov, Roman A.; Yelemesov, Aset A.

2016-01-01

Obesity and gastroesophageal reflux disease (GERD) are serious medical, social, and economic problems of modern society. A pilot randomized two-arm controlled clinical study was conducted to compare laparoscopic plication of the greater gastric curvature combined with Nissen fundoplication (LFN+LGP) versus only Nissen fundoplication (LFN). The…

Feasibility of Providing Culturally Relevant, Brief Interpersonal Psychotherapy for Antenatal Depression in an Obstetrics Clinic: A Pilot Study

ERIC Educational Resources Information Center

Grote, Nancy K.; Bledsoe, Sarah E.; Swartz, Holly A.; Frank, Ellen

2004-01-01

Objective: To minimize barriers to care, ameliorate antenatal depression, and prevent postpartum depression, we conducted a pilot study to assess the feasibility of providing brief interpersonal psychotherapy (IPT-B) to depressed, pregnant patients on low incomes in an obstetrics and gynecological (OB/GYN) clinic. Method: Twelve pregnant,…

77 FR 59911 - Request To Make Special Program for the Law School Clinic Certification Patent Pilot Program

Federal Register 2010, 2011, 2012, 2013, 2014

2012-10-01

...] Request To Make Special Program for the Law School Clinic Certification Patent Pilot Program AGENCY... and Trademark Office (USPTO) is implementing a pilot program in which a law school clinic participating in the USPTO Law School Clinic Certification Pilot Program may file an application for a pro bono...

Impact of Medical Scribes on Physician and Patient Satisfaction in Primary Care.

PubMed

Pozdnyakova, Anastasia; Laiteerapong, Neda; Volerman, Anna; Feld, Lauren D; Wan, Wen; Burnet, Deborah L; Lee, Wei Wei

2018-04-26

Use of electronic health records (EHRs) is associated with physician stress and burnout. While emergency departments and subspecialists have used scribes to address this issue, little is known about the impact of scribes in academic primary care. Assess the impact of a scribe on physician and patient satisfaction at an academic general internal medicine (GIM) clinic. Prospective, pre-post-pilot study. During the 3-month pilot, physicians had clinic sessions with and without a scribe. We assessed changes in (1) physician workplace satisfaction and burnout, (2) time spent on EHR documentation, and (3) patient satisfaction. Six GIM faculty and a convenience sample of their patients (N = 325) at an academic GIM clinic. A 21-item pre- and 44-item post-pilot survey assessed physician workplace satisfaction and burnout. Physicians used logs to record time spent on EHR documentation outside of clinic hours. A 27-item post-visit survey assessed patient satisfaction during visits with and without the scribe. Of six physicians, 100% were satisfied with clinic workflow post-pilot (vs. 33% pre-pilot), and 83% were satisfied with EHR use post-pilot (vs. 17% pre-pilot). Physician burnout was low at baseline and did not change post-pilot. Mean time spent on post-clinic EHR documentation decreased from 1.65 to 0.76 h per clinic session (p = 0.02). Patient satisfaction was not different between patients who had clinic visits with vs. without scribe overall or by age, gender, and race. Compared to patients 65 years or older, younger patients were more likely to report that the physician was more attentive and provided more education during visits with the scribe present (p = 0.03 and 0.02, respectively). Male patients were more likely to report that they disliked having a scribe (p = 0.03). In an academic GIM setting, employment of a scribe was associated with improved physician satisfaction without compromising patient satisfaction.

Psychiatric Residents' Attitudes toward and Experiences with the Clinical-Skills Verification Process: A Pilot Study on U.S. and International Medical Graduates

ERIC Educational Resources Information Center

Rao, Nyapati R.; Kodali, Rahul; Mian, Ayesha; Ramtekkar, Ujjwal; Kamarajan, Chella; Jibson, Michael D.

2012-01-01

Objective: The authors report on a pilot study of the experiences and perceptions of foreign international medical graduate (F-IMG), United States international medical graduate (US-IMG), and United States medical graduate (USMG) psychiatric residents with the newly mandated Clinical Skills Verification (CSV) process. The goal was to identify and…

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…

Pilot study of digital tools to support multimodal hand hygiene in a clinical setting.

PubMed

Thirkell, Gary; Chambers, Joanne; Gilbart, Wayne; Thornhill, Kerrill; Arbogast, James; Lacey, Gerard

2018-03-01

Digital tools for hand hygiene do not share data, limiting their potential to support multimodal programs. The Christie NHS Foundation Trust, United Kingdom, worked with GOJO (in the United States), MEG (in Ireland), and SureWash (in Ireland) to integrate their systems and pilot their combined use in a clinical setting. A 28-bed medical oncology unit piloted the system for 5 weeks. Live data from the tools were combined to create a novel combined risk status metric that was displayed publicly and via a management Web site. The combined risk status reduced over the pilot period. However, larger and longer duration studies are required to reach statistical significance. Staff and especially patient reaction was positive in that 70% of the hand hygiene training events were by patients. The digital tools did not negatively impact clinical workflow and received positive engagement from staff and patients. The combined risk status did not change significantly over the short pilot period because there was also no specific hand hygiene improvement campaign underway at the time of the pilot study. The results indicate that integrated digital tools can provide both rich data and novel tools that both measure impact and provide feedback to support the implementation of multimodal hand hygiene campaigns, reducing the need for significant additional personnel resources. Copyright © 2018 Association for Professionals in Infection Control and Epidemiology, Inc. All rights reserved.

Design of pilot studies to inform the construction of composite outcome measures.

PubMed

Edland, Steven D; Ard, M Colin; Li, Weiwei; Jiang, Lingjing

2017-06-01

Composite scales have recently been proposed as outcome measures for clinical trials. For example, the Prodromal Alzheimer's Cognitive Composite (PACC) is the sum of z-score normed component measures assessing episodic memory, timed executive function, and global cognition. Alternative methods of calculating composite total scores using the weighted sum of the component measures that maximize signal-to-noise of the resulting composite score have been proposed. Optimal weights can be estimated from pilot data, but it is an open question how large a pilot trial is required to calculate reliably optimal weights. In this manuscript, we describe the calculation of optimal weights, and use large-scale computer simulations to investigate the question of how large a pilot study sample is required to inform the calculation of optimal weights. The simulations are informed by the pattern of decline observed in cognitively normal subjects enrolled in the Alzheimer's Disease Cooperative Study (ADCS) Prevention Instrument cohort study, restricting to n=75 subjects age 75 and over with an ApoE E4 risk allele and therefore likely to have an underlying Alzheimer neurodegenerative process. In the context of secondary prevention trials in Alzheimer's disease, and using the components of the PACC, we found that pilot studies as small as 100 are sufficient to meaningfully inform weighting parameters. Regardless of the pilot study sample size used to inform weights, the optimally weighted PACC consistently outperformed the standard PACC in terms of statistical power to detect treatment effects in a clinical trial. Pilot studies of size 300 produced weights that achieved near-optimal statistical power, and reduced required sample size relative to the standard PACC by more than half. These simulations suggest that modestly sized pilot studies, comparable to that of a phase 2 clinical trial, are sufficient to inform the construction of composite outcome measures. Although these findings apply only to the PACC in the context of prodromal AD, the observation that weights only have to approximate the optimal weights to achieve near-optimal performance should generalize. Performing a pilot study or phase 2 trial to inform the weighting of proposed composite outcome measures is highly cost-effective. The net effect of more efficient outcome measures is that smaller trials will be required to test novel treatments. Alternatively, second generation trials can use prior clinical trial data to inform weighting, so that greater efficiency can be achieved as we move forward.

[Perception of ethical aspects in psychiatric patient care: a pilot study].

PubMed

Rabenschlag, Franziska; Steinauer, Regine; Heimann, Regine; Reiter-Theil, Stella

2014-10-01

Research on staff perception of ethical aspects of psychiatric patient care are scarce; little is known about systematic supplies of ethics support in psychiatric institutions. The goal of this pilot study is to inform the implementation of Clinical Ethics Support Services in psychiatric institutions by assessing which topics of psychiatric practice are considered ethically challenging by the staff. Explorative survey as pilot study by questionnaire with clinical staff, quantitative (descriptive) and qualitative (coding) data-analysis. Involuntary treatment, the relationship between healthcare professionals and patients, staff shortage and the collaboration between the professions as well as dealing with patient relatives came up as ethical challenges. Clinical Ethics Support in psychiatric patient care should not only cover aspects that are specific for psychiatry, but also structural topics such as short resources, interprofessional collaboration and communication with relatives. © Georg Thieme Verlag KG Stuttgart · New York.

Safety and efficacy of intravenous infusion of allogeneic cryopreserved mesenchymal stem cells for treatment of chronic kidney disease in cats: results of three sequential pilot studies

PubMed Central

2013-01-01

Introduction Administration of mesenchymal stem cells (MSCs) has been shown to improve renal function in rodent models of chronic kidney disease (CKD), in part by reducing intrarenal inflammation and suppressing fibrosis. CKD in cats is characterized by tubulointerstitial inflammation and fibrosis, and thus treatment with MSCs might improve renal function and urinary markers of inflammation in this disease. Therefore, a series of pilot studies was conducted to assess the safety and efficacy of intravenous administration of allogeneic adipose-derived MSCs (aMSCs) in cats with naturally occurring CKD. Methods Cats enrolled in these studies received an intravenous infusion of allogeneic aMSCs every 2 weeks collected from healthy, young, specific pathogen-free cats. Cats in pilot study 1 (six cats) received 2 × 106 cryopreserved aMSCs per infusion, cats in pilot study 2 (five cats) received 4 × 106 cryopreserved aMSCs per infusion, and cats in pilot study 3 (five cats) received 4 × 106 aMSCs cultured from cryopreserved adipose. Serum biochemistry, complete blood count, urinalysis, urine protein, glomerular filtration rate, and urinary cytokine concentrations were monitored during the treatment period. Changes in clinical parameters were compared statistically by means of repeated measures analysis of variance (ANOVA) followed by Bonferroni’s correction. Results Cats in pilot study 1 had few adverse effects from the aMSC infusions and there was a statistically significant decrease in serum creatinine concentrations during the study period, however the degree of decrease seems unlikely to be clinically relevant. Adverse effects of the aMSC infusion in cats in pilot study 2 included vomiting (2/5 cats) during infusion and increased respiratory rate and effort (4/5 cats). Cats in pilot study 3 did not experience any adverse side effects. Serum creatinine concentrations and glomerular filtration rates did not change significantly in cats in pilot studies 2 and 3. Conclusions Administration of cryopreserved aMSCs was associated with significant adverse effects and no discernible clinically relevant improvement in renal functional parameters. Administration of aMSCs cultured from cryopreserved adipose was not associated with adverse effects, but was also not associated with improvement in renal functional parameters. PMID:23632128

Augmented Reality M-Learning to Enhance Nursing Skills Acquisition in the Clinical Skills Laboratory

ERIC Educational Resources Information Center

Garrett, Bernard M.; Jackson, Cathryn; Wilson, Brian

2015-01-01

Purpose: This paper aims to report on a pilot research project designed to explore if new mobile augmented reality (AR) technologies have the potential to enhance the learning of clinical skills in the lab. Design/methodology/approach: An exploratory action-research-based pilot study was undertaken to explore an initial proof-of-concept design in…

Impact on seniors of the patient-centered medical home: evidence from a pilot study.

PubMed

Fishman, Paul A; Johnson, Eric A; Coleman, Kathryn; Larson, Eric B; Hsu, Clarissa; Ross, Tyler R; Liss, David; Tufano, James; Reid, Robert J

2012-10-01

To assess the impact on health care cost and quality among seniors of a patient-centered medical home (PCMH) pilot at Group Health Cooperative, an integrated health care system in Washington State. A prospective before-and-after evaluation of the experience of seniors receiving primary care services at 1 pilot clinic compared with seniors enrolled at the remaining 19 primary care clinics owned and operated by Group Health. Analyses of secondary data on quality and cost were conducted for 1,947 seniors in the PCMH clinic and 39,396 seniors in the 19 control clinics. Patient experience with care was based on survey data collected from 487 seniors in the PCMH clinic and of 668 in 2 specific control clinics that were selected for their similarities in organization and patient composition to the pilot clinic. After adjusting for baseline, seniors in the PCMH clinic reported higher ratings than controls on 3 of 7 patient experience scales. Seniors in the PCMH clinic had significantly greater quality outcomes over time, but this difference was not significant relative to control. PCMH patients used more e-mail, phone, and specialist visits but fewer emergency services and inpatient admissions for ambulatory care sensitive conditions. At 1 and 2 years, the PCMH and control clinics did not differ significantly in overall costs. A PCMH redesign can be associated with improvements in patient experience and quality without increasing overall cost.

Evaluation of moral case deliberation at the Dutch Health Care Inspectorate: a pilot study.

PubMed

Seekles, Wike; Widdershoven, Guy; Robben, Paul; van Dalfsen, Gonny; Molewijk, Bert

2016-05-21

Moral case deliberation (MCD) as a form of clinical ethics support is usually implemented in health care institutions and educational programs. While there is no previous research on the use of clinical ethics support on the level of health care regulation, employees of regulatory bodies are regularly confronted with moral challenges. This pilot study describes and evaluates the use of MCD at the Dutch Health Care Inspectorate (IGZ). The objective of this pilot study is to investigate: 1) the current way of dealing with moral issues at the IGZ; 2) experience with and evaluation of MCD as clinical ethics support, and 3) future preferences and (perceived) needs regarding clinical ethics support for dealing with moral questions at the IGZ. We performed an explorative pilot study. The research questions were assessed by means of: 1) interviews with MCD participants during four focus groups; and 2) interviews with six key stakeholders at the IGZ. De qualitative data is illustrated by data from questionnaires on MCD outcomes, perspective taking and MCD evaluation. Professionals do not always recognize moral issues. Employees report a need for regular and structured moral support in health care regulation. The MCD meetings are evaluated positively. The most important outcomes of MCD are feeling secure and learning from others. Additional support is needed to successfully implement MCD at the Inspectorate. We conclude that the respondents perceive moral case deliberation as a useful form of clinical ethics support for dealing with moral questions and issues in health care regulation.

A pilot study of distributed knowledge management and clinical decision support in the cloud.

PubMed

Dixon, Brian E; Simonaitis, Linas; Goldberg, Howard S; Paterno, Marilyn D; Schaeffer, Molly; Hongsermeier, Tonya; Wright, Adam; Middleton, Blackford

2013-09-01

Implement and perform pilot testing of web-based clinical decision support services using a novel framework for creating and managing clinical knowledge in a distributed fashion using the cloud. The pilot sought to (1) develop and test connectivity to an external clinical decision support (CDS) service, (2) assess the exchange of data to and knowledge from the external CDS service, and (3) capture lessons to guide expansion to more practice sites and users. The Clinical Decision Support Consortium created a repository of shared CDS knowledge for managing hypertension, diabetes, and coronary artery disease in a community cloud hosted by Partners HealthCare. A limited data set for primary care patients at a separate health system was securely transmitted to a CDS rules engine hosted in the cloud. Preventive care reminders triggered by the limited data set were returned for display to clinician end users for review and display. During a pilot study, we (1) monitored connectivity and system performance, (2) studied the exchange of data and decision support reminders between the two health systems, and (3) captured lessons. During the six month pilot study, there were 1339 patient encounters in which information was successfully exchanged. Preventive care reminders were displayed during 57% of patient visits, most often reminding physicians to monitor blood pressure for hypertensive patients (29%) and order eye exams for patients with diabetes (28%). Lessons learned were grouped into five themes: performance, governance, semantic interoperability, ongoing adjustments, and usability. Remote, asynchronous cloud-based decision support performed reasonably well, although issues concerning governance, semantic interoperability, and usability remain key challenges for successful adoption and use of cloud-based CDS that will require collaboration between biomedical informatics and computer science disciplines. Decision support in the cloud is feasible and may be a reasonable path toward achieving better support of clinical decision-making across the widest range of health care providers. Published by Elsevier B.V.

Successful implementation of clinical practice guidelines for pressure risk management in a home nursing setting.

PubMed

Kapp, Suzanne

2013-10-01

This paper reports an initiative which promoted evidence-based practice in pressure risk assessment and management among home nursing clients in Melbourne, Australia. The aim of this study was to evaluate the introduction and uptake of the Australian Wound Management Association Guidelines for the Prediction and Prevention of Pressure Ulcers. In 2007 a pilot study was conducted. Nurse perspectives (n=21) were obtained via survey and a client profile (n=218) was generated. Audit of the uptake and continued use of the pressure risk screening tool, during the pilot study and later once implemented as standard practice organizational wide, was conducted. Nurses at the pilot site successfully implemented the practice guidelines, pressure risk screening was adopted and supporting resources were well received. Most clients were at low risk of pressure ulcer development. The pilot site maintained and extended their pilot study success, ensuring more than 90% of clients were screened for pressure risk over the 18 months which followed. All other sites performed less well initially, however subsequently improved, meeting the pilot sites success after 18 months. Two years later, the organization continues to screen more than 90% of all clients for pressure risk. Implementation of clinical practice guidelines was successful in the pilot project and pressure risk screening became a well-adopted practice. Success continued following organizational wide implementation. Pilot study findings suggest it may be prudent to monitor the pressure ulcer risk status of low risk clients so as to prevent increasing risk and pressure ulcer development among this group. © 2012 John Wiley & Sons Ltd.

Dietary Effects on Cognition and Pilots' Flight Performance.

PubMed

Lindseth, Glenda N; Lindseth, Paul D; Jensen, Warren C; Petros, Thomas V; Helland, Brian D; Fossum, Debra L

2011-01-01

The purpose of this study was to investigate the effects of diet on cognition and flight performance of 45 pilots. Based on a theory of self-care, this clinical study used a repeated-measure, counterbalanced crossover design. Pilots were randomly rotated through 4-day high-carbohydrate, high-protein, high-fat, and control diets. Cognitive flight performance was evaluated using a GAT-2 full-motion flight simulator. The Sternberg short-term memory test and Vandenberg's mental rotation test were used to validate cognitive flight test results. Pilots consuming a high-protein diet had significantly poorer ( p < .05) overall flight performance scores than pilots consuming high-fat and high-carbohydrate diets.

MindSurf: a pilot study to assess the usability and acceptability of a smartphone app designed to promote contentment, wellbeing, and goal achievement.

PubMed

Carey, Timothy A; Haviland, Jennifer; Tai, Sara J; Vanags, Thea; Mansell, Warren

2016-12-12

The Method of Levels (MOL) is a transdiagnostic cognitive therapy that promotes contentment, wellbeing, and goal achievement through the resolution of internal conflicts underlying psychological distress. MOL, based on Perceptual Control Theory (PCT), was developed in routine clinical practice and has been used effectively across different health services by different practitioners. Access to MOL-style questions through a smartphone app could, potentially, help both the general public maintain robust mental health, and also be a useful adjunct to therapy for clinical populations. The app is called MindSurf because of its focus on helping people explore their thinking. Prior to developing the app and using it with different populations it was necessary to determine whether such an idea would be usable for and acceptable to potential app users. Therefore, a pilot study was conducted with a non-clinical sample to assess the usability and acceptability of the app including monitoring whether the questions delivered in this way were associated with any adverse events. A pilot study using quantitative as well as qualitative methods and incorporating a repeated measures, A-B design was conducted. The 23 participants were healthy adult volunteers who were all either undergraduate students, postgraduate students, or staff of the University of Manchester. They received MOL-style questions on their mobile phones over a 1-week period. Qualitative results were encouraging and indicated that the format and style of questioning were acceptable to participants and did not lead to increased worry or concern. A one-way, repeated measures ANOVA indicated that there was a nonsignificant decrease in scores on the 21-item Depression, Anxiety, and Stress Scale (DASS21) over a 2 week period. The results of the pilot study justified development of MindSurf and further testing once it is available for use. A power analysis indicated that the pilot study was underpowered to detect significant effects but provided important information regarding the appropriate sample size for future research. The pilot study also indicated that future research should investigate the effects of receiving more than three questions per day. Results of the pilot study indicate that MindSurf will be a usable and acceptable app. Its benefits should be further explored through longer studies with larger sample of both the general population as well as clinical populations.

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.

Voluntary attendance of small-group brainstorming tutoring courses intensify new clerk's "excellence in clinical care": a pilot study.

PubMed

Yang, Ling-Yu; Huang, Chia-Chang; Hsu, Hui-Chi; Yang, Ying-Ying; Chang, Ching-Chi; Chuang, Chiao-Lin; Lee, Wei-Shin; Liang, Jen-Feng; Cheng, Hao Min; Huang, Chin-Chou; Lee, Fa-Yauh; Ho, Shung-Tai; Kirby, Ralph

2017-01-06

Clerkship provides a unique way of transferring the knowledge and skills gathered during medical school's curriculum into real-ward clinical care environment. The annual program evaluation has indicated that the training of clerks in diagnostic and clinical reasoning skills needed to be enhanced. Recently, "clinical excellence" program have been promoted in our institution to augment the excellence in clinical care of new clerks. Current study aims to evaluate whether this pilot program improve the "clinical excellence" of new clerks. In a pilot study, groups of new clerks in years 2013 and 2014 voluntarily attended either a small-group brainstorming course or a didactic classroom tutoring courses as part of their 3-month internal medicine clinical rotation block. A third group of new clerks did not join either of the above courses and this group served as the control group. Pre-block/post-block self-assessment and post-block 5-station mini-Objective Subjective Clinical Examinations (OSCEs) were used to evaluate the effectiveness of these two additional courses that trained diagnostic and clinical reasoning skills. Overtime, the percentages of new clerks that attended voluntarily either the small-group brainstorming or classroom tutoring courses were increased. Higher post-block self-assessed diagnostic and clinical reasoning skill scores were found among individuals who attended the small-group brainstorming courses compared to either the didactic group or the control group. In a corresponding manner, the small-group brainstorming group obtained higher summary OSCE diag and OSCE reason scores than either the didactic group or control group. For all basic images/laboratory OSCE stations, the individual diagnostic skill (OSCE diag ) scores of the small-group brainstorming group were higher than those of the didactic group. By way of contrast, only the clinical reasoning skill (OSCE reason ) scores of the basic electrocardiogram and complete blood count + biochemistry OSCE station of thesmall-group brainstorming group were higher than those of the didactic group. Among the small-group brainstorming group, clerks with higher cumulative learning hours (>30-h) had significant higher OSCE diag and OSCE reason scores (>400) than those with less cumulative learning hours. Our pilot study provides a successful example of the use of a small-group tutoring courses for augmenting the diagnostic and clinical reasoning skills of new clerks. The positive results obtained during the initial 2-year long pilot "clinical excellence" program have encouraged the formal implementation of this course as part of the clerkship curriculum.

Brief Report: Prevalence of Pervasive Developmental Disorder in Brazil--A Pilot Study

ERIC Educational Resources Information Center

Paula, Cristiane S.; Ribeiro, Sabrina H.; Fombonne, Eric; Mercadante, Marcos T.

2011-01-01

This pilot study presents preliminary results concerning the prevalence of Pervasive Developmental Disorder (PDD) in South America. It was a three-phase study conducted in a typical town in Southeast Brazil. Case definition was based in a combination of standardized instruments and clinical evaluations by experts. The prevalence of PDD was…

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study.

PubMed

Ross, P; Hubert, J; Wong, W L

2017-02-01

To identify the barriers and facilitators of doctors' engagement with clinical audit and to explore how and why these factors influenced doctors' decisions to engage with the NHS National Clinical Audit Programme. A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study's propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. NHS National PET-CT Clinical Audit Programme. Doctors reporting on the Audit Programme. Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit's usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy.

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

PubMed

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study

PubMed Central

Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community. PMID:25383173

Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

PubMed

Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

Patterns of clinical response to PSA elevation in American Indian/Alaska Native men: a multi-center pilot study.

PubMed

Tilburt, Jon C; Koller, Kathryn; Tiesinga, James J; Wilson, Robin T; Trinh, Anne C; Hill, Kristin; Hall, Ingrid J; Smith, Judith Lee; Ekwueme, Donatus U; Petersen, Wesley O

2013-11-01

To assess clinical treatment patterns and response times among American Indian/Alaska Native men with a newly elevated PSA. We retrospectively identified men ages 50-80 receiving care in one of three tribally-operated clinics in Northern Minnesota, one medical center in Alaska, and who had an incident PSA elevation (> 4 ng/ml) in a specified time period. A clinical response was considered timely if it was documented as occurring within 90 days of the incident PSA elevation. Among 82 AI/AN men identified from medical records with an incident PSA elevation, 49 (60%) received a timely clinical response, while 18 (22%) had no documented clinical response. One in five AI/AN men in our study had no documented clinical action following an incident PSA elevation. Although a pilot study, these findings suggest the need to improve the documentation, notification, and care following an elevated PSA at clinics serving AI/AN men.

Use of platelet rich plasma for the treatment of bicipital tendinopathy in spinal cord injury:: a pilot study.

PubMed

Ibrahim, Victor M; Groah, Suzanne L; Libin, Alexander; Ljungberg, Inger H

2012-01-01

The purpose of study is to explore the efficacy and safety of platelet rich plasma (PRP) in the nonoperative management of shoulder tendinopathy amongst individuals with spinal cord injury. This objective was met by completing a pilot study on the effectiveness and safety of a PRP injection into the biceps tendon demonstrating clinical and ultrasonagraphic pathology. Recent analysis of the preliminary pilot data has demonstrated remarkably convincing results demonstrating both the safety and efficacy of this novel intervention.

Hyperintense white matter lesions in 50 high-altitude pilots with neurologic decompression sickness.

PubMed

McGuire, Stephen A; Sherman, Paul M; Brown, Anthony C; Robinson, Andrew Y; Tate, David F; Fox, Peter T; Kochunov, Peter V

2012-12-01

Neurologic decompression sickness (NDCS) can affect high-altitude pilots, causing variable central nervous system symptoms. Five recent severe episodes prompted further investigation. We report the hyperintense white matter (HWM) lesion imaging findings in 50 U-2 pilot volunteers, and compare 12 U-2 pilots who experienced clinical NDCS to 38 U-2 pilots who did not. The imaging data were collected using a 3T magnetic resonance imaging scanner and high-resolution (1-mm isotropic) three-dimensional fluid-attenuated inversion recovery sequence. Whole-brain and regional lesion volume and number were compared between groups. The NDCS group had significantly increased whole brain and insular volumes of HWM lesions. The intergroup difference in lesion numbers was not significant. A clinical episode of NDCS was associated with a significant increase in HWM lesion volume, especially in the insula. We postulate this to be due to hypobaric exposure rather than hypoxia since all pilots were maintained on 100% oxygen throughout the flight. Further studies will be necessary to better understand the pathophysiology underlying these lesions.

Hyperintense White Matter Lesions in 50 High-Altitude Pilots With Neurologic Decompression Sickness

PubMed Central

McGuire, Stephen A.; Sherman, Paul M.; Brown, Anthony C.; Robinson, Andrew Y.; Tate, David F.; Fox, Peter T.; Kochunov, Peter V.

2013-01-01

Introduction Neurologic decompression sickness (NDCS) can affect high-altitude pilots, causing variable central nervous system symptoms. Five recent severe episodes prompted further investigation. Methods We report the hyperintense white matter (HWM) lesion imaging findings in 50 U-2 pilot volunteers, and compare 12 U-2 pilots who experienced clinical NDCS to 38 U-2 pilots who did not. The imaging data were collected using a 3T magnetic resonance imaging scanner and high-resolution (1-mm isotropic) three-dimensional fluid-attenuated inversion recovery sequence. Whole-brain and regional lesion volume and number were compared between groups. Results The NDCS group had significantly increased whole brain and insular volumes of HWM lesions. The intergroup difference in lesion numbers was not significant. Conclusion A clinical episode of NDCS was associated with a significant increase in HWM lesion volume, especially in the insula. We postulate this to be due to hypobaric exposure rather than hypoxia since all pilots were maintained on 100% oxygen throughout the flight. Further studies will be necessary to better understand the pathophysiology underlying these lesions. PMID:23316539

A new device for intraoperative renal blood flow measurement during open-heart surgery: an experimental study and the clinical pilot study.

PubMed

Tirilomis, Theodor; Popov, Aron F; Hanekop, Gunnar G; Braeuer, Anselm; Quintel, Michael; Schoendube, Friedrich A; Friedrich, Martin G

2013-10-01

Renal blood flow (RBF) may vary during cardiopulmonary bypass and low flow may cause insufficient blood supply of the kidney triggering renal failure postoperatively. Still, a valid intraoperative method of continuous RBF measurement is not available. A new catheter combining thermodilution and intravascular Doppler was developed, first calibrated in an in vitro model, and the catheter specific constant was determined. Then, application of the device was evaluated in a pilot study in an adult cardiovascular population. The data of the clinical pilot study revealed high correlation between the flow velocities detected by intravascular Doppler and the RBF measured by thermodilution (Pearson's correlation range: 0.78 to 0.97). In conclusion, the RBF can be measured excellently in real time using the new catheter, even under cardiopulmonary bypass. © 2013 Wiley Periodicals, Inc. and International Center for Artificial Organs and Transplantation.

Simultaneous LC-MS/MS quantitation of acetaminophen and its glucuronide and sulfate metabolites in human dried blood spot samples collected by subjects in a pilot clinical study.

PubMed

Li, Wenkui; Doherty, John P; Kulmatycki, Kenneth; Smith, Harold T; Tse, Francis Ls

2012-06-01

In support of a pilot clinical trial using acetaminophen as the model compound to assess dried blood spot (DBS) sampling as the method for clinical pharmacokinetic sample collection, a novel sensitive LC-MS/MS method was developed and validated for the simultaneous determination of acetaminophen and its major metabolites, acetaminophen glucuronide and sulfate, in human DBS samples collected by subjects via fingerprick. The validated assay dynamic range was from 50.0 to 5000 ng/ml for each compound using a 1/8´´ (3-mm) disc punched from a DBS sample. Baseline separation of the three analytes was achieved to eliminate the possible impact of insource fragmentation of the conjugated metabolites on the analysis of the parent. The overall extraction efficiency was from 61.3 to 78.8% for the three analytes by direct extraction using methanol. The validated method was successfully implemented in the pilot clinical study with the obtained pharmacokinetic parameters in agreement with the values reported in literature.

Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study.

PubMed

Baldwin, Ann Linda; Vitale, Anne; Brownell, Elise; Kryak, Elizabeth; Rand, William

This blinded, controlled pilot study investigated the effects of Reiki on 46 patients undergoing knee replacement surgery. Of the 3 groups, Reiki, Sham Reiki, and Standard of Care, only the Reiki group showed significant reductions in pain, blood pressure, respiration rate, and state anxiety, which provides evidence for a full-scale clinical study.

Reducing the blame culture through clinical audit in nuclear medicine: a mixed methods study

PubMed Central

Ross, P; Hubert, J

2017-01-01

Objectives To identify the barriers and facilitators of doctors’ engagement with clinical audit and to explore how and why these factors influenced doctors’ decisions to engage with the NHS National Clinical Audit Programme. Design A single-embedded case study. Mixed methods sequential approach with explorative pilot study and follow-up survey. Pilot study comprised 13 semi-structured interviews with purposefully selected consultant doctors over a six-month period. Interview data coded and analysed using directed thematic content analysis with themes compared against the study’s propositions. Themes derived from the pilot study informed the online survey question items. Exploratory factor analysis using STATA and descriptive statistical methods applied to summarise findings. Data triangulation techniques used to corroborate and validate findings across the different methodological techniques. Setting NHS National PET-CT Clinical Audit Programme. Participants Doctors reporting on the Audit Programme. Main Outcome measures Extent of engagement with clinical audit, factors that influence engagement with clinical audit. Results Online survey: 58/59 doctors responded (98.3%). Audit was found to be initially threatening (79%); audit was reassuring (85%); audit helped validate professional competence (93%); participation in audit improved reporting skills (76%). Three key factors accounted for 97.6% of the variance in survey responses: (1) perception of audit’s usefulness, (2) a common purpose, (3) a supportive blame free culture of trust. Factor 1 influenced medical engagement most. Conclusions The study documents performance feedback as a key facilitator of medical engagement with clinical audit. It found that medical engagement with clinical audit was associated with reduced levels of professional anxiety and higher levels of perceived self-efficacy. PMID:28210493

Changes in cognitive function in a randomized trial of physical activity: results of the lifestyle interventions and independence for elders pilot study

USDA-ARS?s Scientific Manuscript database

Background. Cognitive impairment is an important contributor to disability. Limited clinical trial evidence exists regarding the impact of physical exercise on cognitive function (CF). We report results of a pilot study to provide estimates of the relative impact of physical activity (PA) on 1-year ...

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.

Efficacy of Dentaq® Oral and ENT Health Probiotic Complex on Clinical Parameters of Gingivitis in Patients Undergoing Fixed Orthodontic Treatment: A Pilot Study.

PubMed

Kolip, Duygu; Yılmaz, Nuray; Gökkaya, Berna; Kulan, Pinar; Kargul, Betul; MacDonald, Kyle W; Cadieux, Peter A; Burton, Jeremy P; James, Kris M

2016-09-01

Probiotics act as a unique approach to maintaining oral health by supplementing the endogenous oral bacteria with additional naturally occurring beneficial microbes to provide defense against pathogens harmful to teeth and gingiva. The aim of this pilot study was to clinically evaluate the effects of probiotics on plaque accumulation and gingival inflammation in subjects with fixed orthodontics. The pilot study was comprised of 15 healthy patients, aged 11 to 18 years, undergoing fixed orthodontic treatment. Patients used an all-natural, dissolving lozenge containing six proprietary probiotic strains (Dentaq® Oral and ENT Health Probiotic Complex)for 28 days. Gingival Index (GI) according to Löe-Silness and Plaque Index (PI) according to Quigley-Hein for all teeth were measured at baseline (Day Zero) and at the end of the probiotic regimen (Day 28). The mean baseline GI and PI scores within each patient decreased by 28.4% and 35.8%, respectively, by Day 28. Patients reported decreased tooth and gingival pain, decreased oral bleeding, and increased motivation to maintain proper oral hygiene over the course of the study. This pilot study provided preliminary support for the use of Dentaq Oral and ENT Health Probiotic Complex as a safe and effective natural health product for the reduction of plaque accumulation and gingival inflammation. The results demonstrate its potential therapeutic value and open the door for larger scale placebo-controlled clinical studies to verify these findings.

Candida species isolation in peristomal skin in patients with abdominal stomas and correlation to clinical signs: a descriptive pilot study.

PubMed

Morales-Mendoza, Yamilett; Fernández-Martínez, Ramón; Fabián-Victoriano, Ma Rosy; Contreras-Ruiz, José; Vásquez-del-Mercado, Elsa; de Lourdes Suárez-Roa, Maria; Arenas-Guzman, Roberto

2014-11-01

The reported prevalence of candidiasis in peristomal skin varies greatly. Very few studies exist that correlate the clinical findings around the peristomal skin to the mycology. In this study, the authors report on Candida species prevalence, clinical correlation, and mycology.

Digital Family History Data Mining with Neural Networks: A Pilot Study.

PubMed

Hoyt, Robert; Linnville, Steven; Thaler, Stephen; Moore, Jeffrey

2016-01-01

Following the passage of the Health Information Technology for Economic and Clinical Health (HITECH) Act of 2009, electronic health records were widely adopted by eligible physicians and hospitals in the United States. Stage 2 meaningful use menu objectives include a digital family history but no stipulation as to how that information should be used. A variety of data mining techniques now exist for these data, which include artificial neural networks (ANNs) for supervised or unsupervised machine learning. In this pilot study, we applied an ANN-based simulation to a previously reported digital family history to mine the database for trends. A graphical user interface was created to display the input of multiple conditions in the parents and output as the likelihood of diabetes, hypertension, and coronary artery disease in male and female offspring. The results of this pilot study show promise in using ANNs to data mine digital family histories for clinical and research purposes.

The Measurement of Causes of Patient Satisfaction and Dissatisfaction within Clinics at an Army Medical Treatment Facility

DTIC Science & Technology

1984-05-01

Satisfaction Measures Between Clinics.... 39 Lessons Learned From the Pilot Studies ...................... 42 Telephonic Versus Clinic Survey...Between Clinics. 63 Comments from Survey Participants ....................... 64 Lessons Learned from the Study ............................. 67...attempted to apply principles learned from a review of the multitude of studies conducted in the area of patient satisfaction. Validated dimensions of

Pilot study of combination transcriptional modulation therapy with sodium phenylbutyrate and 5-azacytidine in patients with acute myeloid leukemia or myelodysplastic syndrome.

PubMed

Maslak, P; Chanel, S; Camacho, L H; Soignet, S; Pandolfi, P P; Guernah, I; Warrell, R; Nimer, S

2006-02-01

Epigenetic mechanisms underlying tumorigenesis have recently received much attention as potential therapeutic targets of human cancer. We designed a pilot study to target DNA methylation and histone deacetylation through the sequential administration of 5-azacytidine followed by sodium phenylbutyrate (PB) in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Ten evaluable patients (eight AML, two MDS) were treated with seven consecutive daily subcutaneous injections of 5-azacytidine at 75 mg/m2 followed by 5 days of sodium PB given intravenously at a dose of 200 mg/kg. Five patients (50%) were able to achieve a beneficial clinical response (partial remission or stable disease). One patient with MDS proceeded to allogeneic stem cell transplantation and is alive without evidence of disease 39 months later. The combination regimen was well tolerated with common toxicities of injection site skin reaction (90% of the patients) from 5-azacytidine, and somnolence/fatigue from the sodium PB infusion (80% of the patients). Correlative laboratory studies demonstrated the consistent reacetylation of histone H4, although no relationship with the clinical response could be demonstrated. Results from this pilot study demonstrate that a combination approach targeting different mechanisms of transcriptional modulation is clinically feasible with acceptable toxicity and measurable biologic and clinical outcomes.

LAM Pilot Study with Imatinib Mesylate (LAMP-1)

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie Strange, MD...completion dates or the percentage of completion. The LAMP-1 study is designed to generate short-term safety and efficacy data...block the growth of LAM cells through initiation of targeted cell death. This study employs a small clinical trial design using 20 participants at two

A mixed methods pilot study to investigate the impact of a hospital-specific iPhone application (iTreat) within a British junior doctor cohort.

PubMed

Payne, Karl Fb; Weeks, Lucy; Dunning, Paul

2014-03-01

We present a pilot study to investigate the impact of introducing a hospital-specific smartphone application into a cohort of British junior doctors. We created the iPhone application 'iTreat' that contained disease management and antibiotic dosing guidelines specific to our hospital, together with a postgraduate education department really simple syndication feed, a contact number phonebook and a favourites section. This intervention was trialled in a group of 39 foundation grade junior doctors, in a UK hospital, for a time period of 4 months. Mixed methods data capture, utilising survey and semi-structured interviews, was used to evaluate application usage patterns and potential barriers to endorsement of smartphone technology in the hospital setting. Sixty eight per cent of participants felt the application saved them time during clinical activities, with a decrease in the frequency of participants not referring to hospital clinical guidelines. The findings from this pilot study point towards the internal hospital environment as having a major impact upon smartphone usage. Participants viewed smartphone use as unprofessional in the ward-based setting, with a perceived negative attitude from other healthcare staff. An understanding of how healthcare staff choose to utilise smartphones in the clinical environment is crucial to enable the successful assimilation of smartphone technology into the hospital setting. This pilot study provides experience and parameters for future substantive studies being carried out by this group.

Building youths' resilience within a psychiatric outpatient setting: results from a pilot clinical intervention project.

PubMed

Waaktaar, Trine; Christie, Helen J; Borge, Anne Inger Helmen; Torgersen, Svenn

2004-02-01

The relevance of resilience research for clinical practice has not yet been established. In this intervention pilot study, the aim was to explore how group work based on enhancing the participants' creativity, self-efficacy, active coping, and sense of continuity could be utilized within a clinical context for adolescents with stressful background experiences. 31 participants and 24 parents completed pre-, post-, and 1-yr. follow-up assessments of the youths' behavior difficulties, as well as depression, positive life attitude, coping, and prosocial behavior. Apart from a drop in self-rated prosocial behavior, no significant treatment effects were found. Implications for clinical practice and research are indicated.

Dietary Effects on Cognition and Pilots’ Flight Performance

PubMed Central

Lindseth, Glenda N.; Lindseth, Paul D.; Jensen, Warren C.; Petros, Thomas V.; Helland, Brian D.; Fossum, Debra L.

2017-01-01

The purpose of this study was to investigate the effects of diet on cognition and flight performance of 45 pilots. Based on a theory of self-care, this clinical study used a repeated-measure, counterbalanced crossover design. Pilots were randomly rotated through 4-day high-carbohydrate, high-protein, high-fat, and control diets. Cognitive flight performance was evaluated using a GAT-2 full-motion flight simulator. The Sternberg short-term memory test and Vandenberg’s mental rotation test were used to validate cognitive flight test results. Pilots consuming a high-protein diet had significantly poorer (p < .05) overall flight performance scores than pilots consuming high-fat and high-carbohydrate diets. PMID:29353985

The Effect of Aroma Hand Massage Therapy for People with Dementia.

PubMed

Yoshiyama, Kazuyo; Arita, Hideko; Suzuki, Jinichi

2015-12-01

Clinical aromatherapy is a complementary therapy that may be very helpful for elderly dementia care. Aromatherapy may reduce the behavioral and psychological symptoms of dementia (BPSD), improve quality of care, and thus improve the quality of life for people with dementia. In this pilot study, aroma hand massage therapy was used for elderly patients in a medical institution in Japan. The study assessed the effectiveness and safety of clinical aromatherapy as part of routine integrative care among people with dementia in a clinical care setting. The randomized, crossover pilot trials were performed among 14 patients with mild-to-moderate dementia older than age 65 years living in a nursing home in Nara, Japan. Participants were divided into two groups and offered, alternately, control therapy and clinical aromatherapy 3 times a week for the 4-week trials. The effects on BPSD and activities of daily living (ADLs) were evaluated quantitatively before and after the study and 4 weeks after the study ended as a follow-up. Observation records were also collected to obtain qualitative data. The quantitative data showed that neither therapy significantly improved the BPSD or ADL results. The qualitative data were classified into four main categories-mood, behavior, verbal communication, and nonverbal communication-reflecting the positive experiences of participants during both therapies. No harmful reactions or changes in medication occurred during the study. This pilot study demonstrated that clinical aromatherapy was clinically safe but did not lead to statistically significant improvements in BPSD or ADL among people with dementia. Further research on therapeutic effects is needed to develop high-quality care with clinical aromatherapy for elderly patients with dementia in Japan and to fully establish evidence for effective and safe practice in health care institutions.

Comparison of mania patients suitable for treatment trials versus clinical treatment

PubMed Central

Talamo, Alessandra; Baldessarini, Ross J.; Centorrino, Franca

2008-01-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential “research subjects” met all 10 exclusion criteria. The remaining 52 “clinical patients” differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between “research subjects” and “clinical patients.” PMID:18484680

Comparison of mania patients suitable for treatment trials versus clinical treatment.

PubMed

Talamo, Alessandra; Baldessarini, Ross J; Centorrino, Franca

2008-08-01

It remains uncertain whether bipolar disorder (BPD) patients in randomized-controlled trials (RCTs) are sufficiently representative of clinically encountered patients as to guide clinical-therapeutic practice. We complied inclusion/exclusion criteria by frequency from reports of 21 RCTs for mania, and applied them in a pilot study of patients hospitalized for DSM-IV BPD manic/mixed states to compare characteristics and clinical responses of patients who did versus did not meet exclusion criteria. From 27 initially identified inclusion/exclusion criteria ranked by citation frequency, we derived six inclusion, and 10 non-redundant-exclusion factors. Of 67 consecutive patients meeting inclusion criteria, 15 (22.4%) potential "research subjects" met all 10 exclusion criteria. The remaining 52 "clinical patients" differed markedly on exclusion criteria, including more psychiatric co-morbidity, substance abuse, involuntary hospitalization, and suicide attempts or violence, but were otherwise similar. In both groups responses to clinically determined inpatient treatments were similar, including improvement in mania ratings. Based on applying reported inclusion/exclusion criteria for RCTs to a pilot sample of hospitalized-manic patients, those likely to be included in modern RCTs were similar to patients who would be excluded, most notably in short-term antimanic-treatment responses. The findings encourage further comparisons of subjects included/excluded from RCTs to test potential clinical generalizability of research findings. The pilot study is limited in numbers and exposure times with which to test for the minor differences between "research subjects" and "clinical patients." (c) 2008 John Wiley & Sons, Ltd.

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.

Prevalence of fatigue in a group of airline pilots.

PubMed

Reis, Cátia; Mestre, Catarina; Canhão, Helena

2013-08-01

Fatigue is a common phenomenon in airline pilots that can impair alertness and ability of crewmembers to safely operate an aircraft and perform safety related tasks. Fatigue can increase the risk of an incident or even an accident. This study provides the first prevalence values for clinically significant fatigue in Portuguese airline pilots. The hypothesis that medium/short-haul pilots may currently present different levels of fatigue than long-haul pilots was also tested. A survey was conducted by requesting Portuguese airline pilots to complete questionnaires placed in the pilots' personal lockers from 1 April until 15 May 2012. The questionnaire included the self-response Fatigue Severity Scale (FSS) to measure subjective fatigue and some additional questions concerning perception of fatigue by pilots. The prevalence values for total and mental fatigue achieved in the Portuguese airline pilots were: 89.3% (FSS > or = 4) and 94.1% (FSS > or = 4) when splitting the sample in two subsamples, long- and medium/short-haul pilots. Levels of total and mental fatigue were higher for medium/short-haul pilots. The analysis of fatigue levels in each type of aviator showed that medium/short-haul pilots presented the highest levels of total and mental fatigue. This study produced the first prevalence values of total and mental fatigue among Portuguese airline pilots, which represents a great step to understanding and addressing this critical phenomenon.

Development of an instrument to measure the use of behaviors taught in the American Physical Therapy Association Clinical Instructor Education and Credentialing Program (APTA CIECP): a pilot study.

PubMed

Bridges, Patricia H; Carter, Vincent; Rehm, Stephanie; Tintl, Sara Bowers; Halperin, Rebecca; Kniesly, Elizabeth; Pelino, Soni

2013-01-01

Conduct a pilot study to establish the reliability and validity of a survey instrument that directly measures the objectives and content of the APTA CIECP; and measure the self-reported frequency of use of the behaviors taught in the APTA CIECP. Eighteen (18) APTA credentialed CIs. Develop a web-based survey consisting of 58 items representative of the behaviors taught in the APTA CIECP and 8 demographic characteristics. Establish the content validity and reliability of the survey instrument. Conduct a descriptive analysis of the frequency of self-reported use of the behaviors. The APTA Clinical Instructor Education Board (CIEB) reviewed the items and determined that the items matched the objectives and content of the APTA CIECP, thereby establishing content validity. Cronbach's alpha coefficients ranging from 0.79-0.90 confirmed the reliability. The overall mean for all items on a 1-6 scale was 4.81. The content validity and reliability of the survey instrument were established. The outcomes of this pilot study suggest that when measured by a valid and reliable instrument that is representative of the objectives and content of the CIECP, the behaviors taught in the CIECP are being applied in the clinical setting by APTA credentialed clinical instructors.

Heart rate prediction for coronary artery disease patients (CAD): Results of a clinical pilot study.

PubMed

Müller-von Aschwege, Frerk; Workowski, Anke; Willemsen, Detlev; Müller, Sebastian M; Hein, Andreas

2015-01-01

This paper describes the results of a pilot study with cardiac patients based on information that can be derived from a smartphone. The idea behind the study is to design a model for estimating the heart rate of a patient before an outdoor walking session for track planning, as well as using the model for guidance during an outdoor session. The model allows estimation of the heart rate several minutes in advance to guide the patient and avoid overstrain before its occurrence. This paper describes the first results of the clinical pilot study with cardiac patients taking β-blockers. 9 patients have been tested on a treadmill and during three outdoor sessions each. The results have been derived and three levels of improvement have been tested by cross validation. The overall result is an average Median Absolute Deviation (MAD) of 4.26 BPM between measured heart rate and smartphone sensor based model estimation.

Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention

PubMed Central

Murchie, Peter; Allan, Julia L; Brant, William; Dennis, Matthew; Hall, Susan; Masthoff, Judith; Walter, Fiona M; Johnston, Marie

2015-01-01

Objectives To develop a digital intervention to prompt, support, and respond to the outcomes of total skin self-examinations (TSSEs) at home by people treated for cutaneous melanoma. Design A complex intervention development study. Setting Northeast Scotland. Participants Semistructured scoping interviews; people previously treated for cutaneous melanoma (n=21). Pilot testing: people treated for melanoma stages 0–2C (n=20); general practitioners (n=6); and a nurse specialist in dermatology (n=1). Intervention A tablet-based digital intervention designed to prompt and support TSSEs comprising instructional videos and electronic reporting (including photographs) to a clinical nurse specialist in dermatology, with subsequent clinical triage. Primary and secondary outcome measures Qualitative assessment of intervention feasibility and acceptability, and quantitative assessment of intentions and confidence to perform TSSEs in pilot participants. Results The majority of pilot participants were strongly positive and adhered well to the intervention (n=15), with 7 of these reporting symptoms of concern at some point during the 6-month pilot. 4 patients complied intermittently, 3 reporting skin problems at least once during the pilot, and 1 withdrew. 2 patients underwent skin surgery as a result of participating in the pilot, with 1 diagnosed as having a recurrent melanoma and the other, a benign lesion. A number of practical issues to improve the usability of the intervention were identified. The proportion of participants reporting intention to check their skin at least monthly increased during the intervention as did confidence to conduct a skin check. Conclusions People previously treated for cutaneous melanoma are prepared to use digital technology to support them in conducting TSSE. An intervention has been developed which is practical, effective and safe, and after addressing minor practical issues, could now be evaluated for clinical outcomes in a randomised clinical trial. PMID:26251412

Total skin self-examination at home for people treated for cutaneous melanoma: development and pilot of a digital intervention.

PubMed

Murchie, Peter; Allan, Julia L; Brant, William; Dennis, Matthew; Hall, Susan; Masthoff, Judith; Walter, Fiona M; Johnston, Marie

2015-08-06

To develop a digital intervention to prompt, support, and respond to the outcomes of total skin self-examinations (TSSEs) at home by people treated for cutaneous melanoma. A complex intervention development study. Northeast Scotland. Semistructured scoping interviews; people previously treated for cutaneous melanoma (n=21). Pilot testing: people treated for melanoma stages 0-2C (n=20); general practitioners (n=6); and a nurse specialist in dermatology (n=1). A tablet-based digital intervention designed to prompt and support TSSEs comprising instructional videos and electronic reporting (including photographs) to a clinical nurse specialist in dermatology, with subsequent clinical triage. Qualitative assessment of intervention feasibility and acceptability, and quantitative assessment of intentions and confidence to perform TSSEs in pilot participants. The majority of pilot participants were strongly positive and adhered well to the intervention (n=15), with 7 of these reporting symptoms of concern at some point during the 6-month pilot. 4 patients complied intermittently, 3 reporting skin problems at least once during the pilot, and 1 withdrew. 2 patients underwent skin surgery as a result of participating in the pilot, with 1 diagnosed as having a recurrent melanoma and the other, a benign lesion. A number of practical issues to improve the usability of the intervention were identified. The proportion of participants reporting intention to check their skin at least monthly increased during the intervention as did confidence to conduct a skin check. People previously treated for cutaneous melanoma are prepared to use digital technology to support them in conducting TSSE. An intervention has been developed which is practical, effective and safe, and after addressing minor practical issues, could now be evaluated for clinical outcomes in a randomised clinical trial. 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.

A Pilot Study of Reasons and Risk Factors for "No-Shows" in a Pediatric Neurology Clinic.

PubMed

Guzek, Lindsay M; Fadel, William F; Golomb, Meredith R

2015-09-01

Missed clinic appointments lead to decreased patient access, worse patient outcomes, and increased healthcare costs. The goal of this pilot study was to identify reasons for and risk factors associated with missed pediatric neurology outpatient appointments ("no-shows"). This was a prospective cohort study of patients scheduled for 1 week of clinic. Data on patient clinical and demographic information were collected by record review; data on reasons for missed appointments were collected by phone interviews. Univariate and multivariate analyses were conducted using chi-square tests and multiple logistic regression to assess risk factors for missed appointments. Fifty-nine (25%) of 236 scheduled patients were no-shows. Scheduling conflicts (25.9%) and forgetting (20.4%) were the most common reasons for missed appointments. When controlling for confounding factors in the logistic regression, Medicaid (odds ratio 2.36), distance from clinic, and time since appointment was scheduled were associated with missed appointments. Further work in this area is needed. © The Author(s) 2014.

Promoting early presentation of breast cancer in older women: sustained effect of an intervention to promote breast cancer awareness in routine clinical practice.

PubMed

Dodd, Rachael H; Forster, Alice S; Sellars, Sarah; Patnick, Julietta; Ramirez, Amanda J; Forbes, Lindsay J L

2017-06-05

Older women have poorer survival from breast cancer, which may be at least partly due to poor breast cancer awareness leading to delayed presentation and more advanced stage at diagnosis. In a randomised trial, an intervention to promote early presentation of breast cancer in older women increased breast cancer awareness at 1 year compared with usual care (24 versus 4%). We examined its effectiveness in routine clinical practice. We piloted the intervention delivered by practising health professionals to women aged about 70 in four breast screening services. We measured the effect on breast cancer awareness at 1 year compared with comparison services, where women did not receive the intervention. At 1 year, 25% of women in pilot services were breast cancer aware compared with 4% in comparison services (p = 0.001). The components of breast cancer awareness were knowledge of breast cancer non-lump symptoms (pilot: 63% vs comparison: 82% at 1 year; OR = 2.56, 95% CI 1.92-3.42), knowledge of age related risk (pilot: 8% vs comparison: 36% at 1 year; OR = 5.56, 95% CI 4.0-7.74) and reported breast checking (pilot: 70% vs comparison: 78% at 1 year; OR = 1.49, 95% CI 1.13-1.96). The intervention may be as effective in routine clinical practice as in a randomised controlled trial. This intervention has the potential to reduce patient delay in the diagnosis of breast cancer in older women. The PEP trial was registered with the International Standard Registered Clinical/soCial sTudy Number (ISRCTN) as a clinical trial ( ISRCTN31994827 ) on 3rd October 2007.

Fractional photothermolysis laser treatment of male pattern hair loss.

PubMed

Kim, Won-Serk; Lee, Hye In; Lee, Jin Woong; Lim, Yun Young; Lee, Seung Jae; Kim, Beom Joon; Kim, Myeung Nam; Song, Kye Yong; Park, Won Serk

2011-01-01

Various trials have been conducted on the management of male pattern hair loss (MPHL). A variety of laser and light sources have been used for the treatment of MPHL. To understand the effects of a 1,550-nm fractional erbium-glass laser on the hair cycle in an alopecia mouse model and to study the clinical effects of the same laser used as treatment for MPHL. Irradiation was applied to the shaved skin of C3H/HeN mice using various energy and density settings and varied irradiation intervals. In a clinical pilot study involving human subjects, 20 participants were treated over five sessions at 2-week intervals. A fractional photothermolysis laser was used at the energy of 5 mJ and a total density of 300 spots/cm(2). In the animal study, the hair stimulation effects were dependent upon the energy level, density, and irradiation interval. The anagen conversion of hair and the increase in Wnt 5a, β-catenin signals were observed. In the human pilot study, incremental improvements in hair density and growth rate were observed. This pilot study showed that a 1,550-nm fractional erbium-glass laser might induce hair growth, but more intensive studies are required to clarify the clinical applications of this treatment. © 2010 by the American Society for Dermatologic Surgery, Inc.

Pilot study of brain morphometry in a sample of Brazilian children with attention deficit hyperactivity disorder: influence of clinical presentation.

PubMed

Pastura, Giuseppe; Kubo, Tadeu Takao Almodovar; Gasparetto, Emerson Leandro; Figueiredo, Otavio; Mattos, Paulo; Prüfer Araújo, Alexandra

2017-12-01

Currently, the diagnosis of attention deficit hyperactivity disorder (ADHD) rests on clinical criteria. Nonetheless, neuroimaging studies have demonstrated that children with ADHD have different cortical thickness and volume measures to typically developing children (TDC). In general, studies do not evaluate the influence of clinical presentation in the brain morphometry of ADHD children. Our objective was to perform a pilot study in order to evaluate cortical thickness and brain volume in a sample of Brazilian ADHD children and compare these to those of TDC, taking into account the influence of clinical presentation. We performed an analytic study comparing 17 drug-naïve ADHD children of both genders, aged between 7 and 10, and 16 TDC. ADHD subjects were first considered as one group and further separated based on clinical presentation. The brain volume did not differ between patients and TDC. Smaller cortical thicknesses were identified on the left superior, medium and inferior temporal cortex, as well as in the left inferior parietal cortex. When compared to TDC, combined and inattentive ADHD presentations depicted smaller cortical thickness with high significance and power. The same magnitude of results was not observed when comparing inattentive ADHD and TDC. In this pilot study, ADHD is associated with abnormalities involving the cortical thickness of the posterior attentional system. The cortical thickness in the left superior, medium and inferior temporal cortex, as well as in the left inferior parietal cortex may differ according to ADHD presentations.

Short-term differences in drug prices after implementation of the national essential medicines system: A case study in rural Jiangxi Province, China.

PubMed

Wang, Junyong; Liu, Xia; Wang, Suzhen; Chen, Heli; Wang, Xun; Zhou, Wei; Wang, Li; Zhu, Yanchen; Zheng, Xianping; Hao, Mo

2015-01-01

China's 2009 national essential medicine system (NEMS) was designed to reduce prices through a zero-markup policy and a centralized bidding system. To analyze NEMS's short-term impact on drug prices, we estimated the retail and wholesale prices before and after the reform at health institutions in rural Jiangxi Province. We undertook two cross-sectional surveys of prices of 39 medicines in November 2008 and May 2010, calculated inflation adjusted prices, and used the Wilcoxon signed-rank and rank-sum tests to examine price changes at different health institutions. Retail prices at pilot (P < 0.01) and nonpilot (P < 0.01) township health centers decreased significantly, whereas the declines at retail pharmacies (P = 0.57) and village clinics (P = 0.29) were insignificant. The decline at pilot township health centers was the largest, compared with other kinds of health institutions (P < 0.01). Retail prices of essential and non-essential medicines declined significantly at pilot facilities (P < 0.05); price drops for non-essential medicines occurred only at pilot facilities (P < 0.05). No significant decline of wholesale prices were found at pilot (P = 0.86) and nonpilot units (P = 0.18), retail pharmacies (P = 0.18), and village clinics (P = 0.20). The wholesale prices changes at pilot units before and after the reform were higher than at nonpilot public units (P < 0.05), retail pharmacies (P < 0.05), and village clinics (P < 0.05). While the NEMS zero-markup policy significantly reduced retail prices at pilot health institutions, the centralized bidding system was insufficient to lower wholesale prices. A drug price management system should be constructed to control medicine prices and a long-term price information system is needed to monitor price changes.

Implementation of computerized physician order entry in National Guard Hospitals: assessment of critical success factors.

PubMed

Altuwaijri, Majid M; Bahanshal, Abdullah; Almehaid, Mona

2011-09-01

The purpose of this study is to describe the needs, process and experience of implementing a computerized physician order entry (CPOE) system in a leading healthcare organization in Saudi Arabia. The National Guard Health Affairs (NGHA) deployed the CPOE in a pilot department, which was the intensive care unit (ICU) in order to assess its benefits and risks and to test the system. After the CPOE was implemented in the ICU area, a survey was sent to the ICU clinicians to assess their perception on the importance of 32 critical success factors (CSFs) that was acquired from the literature. The project team also had several meetings to gather lessons learned from the pilot project in order to utilize them for the expansion of the project to other NGHA clinics and hospitals. The results of the survey indicated that the selected CSFs, even though they were developed with regard to international settings, are very much applicable for the pilot area. The top three CSFs rated by the survey respondents were: The "before go-live training", the adequate clinical resources during implementation, and the ordering time. After the assessment of the survey and the lessons learned from the pilot project, NGHA decided that the potential benefits of the CPOE are expected to be greater the risks expected. The project was then expanded to cover all NGHA clinics and hospitals in a phased approach. Currently, the project is in its final stages and expected to be completed by the end of 2011. The role of CPOE systems is very important in hospitals in order to reduce medication errors and to improve the quality of care. In spite of their great benefits, many studies suggest that a high percentage of these projects fail. In order to increase the chances of success and due to the fact that CPOE is a clinical system, NGHA implemented the system first in a pilot area in order to test the system without putting patients at risk and to learn from mistakes before expanding the system to other areas. As a result of the pilot project, NGHA developed a list of CSFs to increase the likelihood of project success for the expansion of the system to other clinics and hospitals. The authors recommend a future study for the CPOE implementation to be done that covers the implementation in all the four NGHA hospitals. The results of the study can then be generalized to other hospitals in Saudi Arabia.

Evaluating the financial impact of clinical trials in oncology: results from a pilot study from the Association of American Cancer Institutes/Northwestern University clinical trials costs and charges project.

PubMed

Bennett, C L; Stinson, T J; Vogel, V; Robertson, L; Leedy, D; O'Brien, P; Hobbs, J; Sutton, T; Ruckdeschel, J C; Chirikos, T N; Weiner, R S; Ramsey, M M; Wicha, M S

2000-08-01

Medical care for clinical trials is often not reimbursed by insurers, primarily because of concern that medical care as part of clinical trials is expensive and not part of standard medical practice. In June 2000, President Clinton ordered Medicare to reimburse for medical care expenses incurred as part of cancer clinical trials, although many private insurers are concerned about the expense of this effort. To inform this policy debate, the costs and charges of care for patients on clinical trials are being evaluated. In this Association of American Cancer Institutes (AACI) Clinical Trials Costs and Charges pilot study, we describe the results and operational considerations of one of the first completed multisite economic analyses of clinical trials. Our pilot effort included assessment of total direct medical charges for 6 months of care for 35 case patients who received care on phase II clinical trials and for 35 matched controls (based on age, sex, disease, stage, and treatment period) at five AACI member cancer centers. Charge data were obtained for hospital and ancillary services from automated claims files at individual study institutions. The analyses were based on the perspective of a third-party payer. The mean age of the phase II clinical trial patients was 58.3 years versus 57.3 years for control patients. The study population included persons with cancer of the breast (n = 24), lung (n = 18), colon (n = 16), prostate (n = 4), and lymphoma (n = 8). The ratio of male-to-female patients was 3:4, with greater than 75% of patients having stage III to IV disease. Total mean charges for treatment from the time of study enrollment through 6 months were similar: $57,542 for clinical trial patients and $63,721 for control patients (1998 US$; P =.4) Multisite economic analyses of oncology clinical trials are in progress. Strategies that are not likely to overburden data managers and clinicians are possible to devise. However, these studies require careful planning and coordination among cancer center directors, finance department personnel, economists, and health services researchers.

Implementing a clinical ethics needs assessment survey: results of a pilot study (part 2 of 2).

PubMed

Frolic, Andrea; Andreychuk, Sandra; Seidlitz, Wendy; Djuric-Paulin, Angela; Flaherty, Barb; Jennings, Barb; Peace, Donna

2013-03-01

This paper details the implementation of the Clinical Ethics Needs Assessment Survey (CENAS) through a pilot study in five units within Hamilton Health Sciences. We describe how these pilot sites were selected, how we implemented the survey, the significant results and our interpretation of the findings. The primary goal of this paper is to share our experiences using this tool, specifically the challenges we encountered conducting a staff ethics needs assessment across different units in a large teaching hospital, and the facilitators to our success. We conclude with a discussion of the limitations of this study, our plans for using the results to develop a proactive ethics education strategy, and suggestions for other organizations wishing to adapt the CENAS to assess their staff ethics needs. Our secondary goal is to advance the "quality agenda" for ethics programs by demonstrating how a tool like the CENAS can be used to design more effective educational interventions, and to support strategic planning and proactive priority-setting for ethics programs.

Comparison of organochlorine chemical body burdens of female breast cancer cases with cancer free women in Rio Grande do Sul, Brazil--Pilot Study

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

Erdmann, C.A.; Petreas, M.X.; Caleffi, M.

This pilot study collected preliminary data to examine known and suspected breast cancer risk factors among women living in rural and urban areas in the state of Rio Grande do Sul, Brazil by questionnaire. In addition, the body burden levels of a panel of organochlorines was measured in a small clinic-based prospective sample.

Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis.

PubMed

Meltzer, Eli O; Hadley, James; Blaiss, Michael; Benninger, Michael; Kimel, Miriam; Kleinman, Leah; Dupclay, Leon; Garcia, Jorge; Leahy, Michael; Georges, George

2005-02-01

To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. B-20.

SU-E-T-23: A Developing Australian Network for Datamining and Modelling Routine Radiotherapy Clinical Data and Radiomics Information for Rapid Learning and Clinical Decision Support

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

Thwaites, D; Holloway, L; Bailey, M

2015-06-15

Purpose: Large amounts of routine radiotherapy (RT) data are available, which can potentially add clinical evidence to support better decisions. A developing collaborative Australian network, with a leading European partner, aims to validate, implement and extend European predictive models (PMs) for Australian practice and assess their impact on future patient decisions. Wider objectives include: developing multi-institutional rapid learning, using distributed learning approaches; and assessing and incorporating radiomics information into PMs. Methods: Two initial standalone pilots were conducted; one on NSCLC, the other on larynx, patient datasets in two different centres. Open-source rapid learning systems were installed, for data extraction andmore » mining to collect relevant clinical parameters from the centres’ databases. The European DSSs were learned (“training cohort”) and validated against local data sets (“clinical cohort”). Further NSCLC studies are underway in three more centres to pilot a wider distributed learning network. Initial radiomics work is underway. Results: For the NSCLC pilot, 159/419 patient datasets were identified meeting the PM criteria, and hence eligible for inclusion in the curative clinical cohort (for the larynx pilot, 109/125). Some missing data were imputed using Bayesian methods. For both, the European PMs successfully predicted prognosis groups, but with some differences in practice reflected. For example, the PM-predicted good prognosis NSCLC group was differentiated from a combined medium/poor prognosis group (2YOS 69% vs. 27%, p<0.001). Stage was less discriminatory in identifying prognostic groups. In the good prognosis group two-year overall survival was 65% in curatively and 18% in palliatively treated patients. Conclusion: The technical infrastructure and basic European PMs support prognosis prediction for these Australian patient groups, showing promise for supporting future personalized treatment decisions, improved treatment quality and potential practice changes. The early indications from the distributed learning and radiomics pilots strengthen this. Improved routine patient data quality should strengthen such rapid learning systems.« less

Re-use of pilot data and interim analysis of pivotal data in MRMC studies: a simulation study

NASA Astrophysics Data System (ADS)

Chen, Weijie; Samuelson, Frank; Sahiner, Berkman; Petrick, Nicholas

2017-03-01

Novel medical imaging devices are often evaluated with multi-reader multi-case (MRMC) studies in which radiologists read images of patient cases for a specified clinical task (e.g., cancer detection). A pilot study is often used to measure the effect size and variance parameters that are necessary for sizing a pivotal study (including sizing readers, non-diseased and diseased cases). Due to the practical difficulty of collecting patient cases or recruiting clinical readers, some investigators attempt to include the pilot data as part of their pivotal study. In other situations, some investigators attempt to perform an interim analysis of their pivotal study data based upon which the sample sizes may be re-estimated. Re-use of the pilot data or interim analyses of the pivotal data may inflate the type I error of the pivotal study. In this work, we use the Roe and Metz model to simulate MRMC data under the null hypothesis (i.e., two devices have equal diagnostic performance) and investigate the type I error rate for several practical designs involving re-use of pilot data or interim analysis of pivotal data. Our preliminary simulation results indicate that, under the simulation conditions we investigated, the inflation of type I error is none or only marginal for some design strategies (e.g., re-use of patient data without re-using readers, and size re-estimation without using the effect-size estimated in the interim analysis). Upon further verifications, these are potentially useful design methods in that they may help make a study less burdensome and have a better chance to succeed without substantial loss of the statistical rigor.

Perceptions of Adolescents With Cancer Related to a Pain Management App and Its Evaluation: Qualitative Study Nested Within a Multicenter Pilot Feasibility Study

PubMed Central

Stevens, Bonnie J; Nathan, Paul C; Seto, Emily; Cafazzo, Joseph A; Johnston, Donna L; Hum, Vanessa; Stinson, Jennifer N

2018-01-01

Background Pain in adolescents with cancer is common and negatively impacts health-related quality of life. The Pain Squad+ smartphone app, capable of providing adolescents with real-time pain management support, was developed to enhance pain management using a phased approach (ie, systematic review, consensus conference and vetting, iterative usability testing cycles). A 28-day Pain Squad+ pilot was conducted with 40 adolescents with cancer to evaluate the feasibility of implementing the app in a future clinical trial and to obtain estimates of treatment effect. Objective The objective of our nested qualitative study was to elucidate the perceptions of adolescents with cancer to determine the acceptability and perceived helpfulness of Pain Squad+, suggestions for app improvement, and satisfaction with the pilot study protocol. Methods Post pilot study participation, telephone-based, semistructured, and audio-recorded exit interviews were conducted with 20 adolescents with cancer (12-18 years). All interviews were transcribed and independently coded by 2 study team members. Content analysis was conducted to identify data categories and overarching themes. Results Five major themes comprising multiple categories and codes emerged. These themes focused on the acceptability of the intervention, acceptability of the study, the perceived active ingredients of the intervention, the suitability of the intervention to adolescents’ lives, and recommendations for intervention improvement. Conclusions Overall, Pain Squad+ and the pilot study protocol were acceptable to adolescents with cancer. Suggestions for intervention and study improvements will be incorporated into the design of a future randomized clinical trial (RCT) aimed at assessing the effectiveness of Pain Squad+ on adolescents with cancer health outcomes. PMID:29625951

Gaze-Based Assistive Technology - Usefulness in Clinical Assessments.

PubMed

Wandin, Helena

2017-01-01

Gaze-based assistive technology was used in informal clinical assessments. Excerpts of medical journals were analyzed by directed content analysis using a model of communicative competence. The results of this pilot study indicate that gaze-based assistive technology is a useful tool in communication assessments that can generate clinically relevant information.

The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency.

PubMed

Sim, Julius; Lewis, Martyn

2012-03-01

To investigate methods to determine the size of a pilot study to inform a power calculation for a randomized controlled trial (RCT) using an interval/ratio outcome measure. Calculations based on confidence intervals (CIs) for the sample standard deviation (SD). Based on CIs for the sample SD, methods are demonstrated whereby (1) the observed SD can be adjusted to secure the desired level of statistical power in the main study with a specified level of confidence; (2) the sample for the main study, if calculated using the observed SD, can be adjusted, again to obtain the desired level of statistical power in the main study; (3) the power of the main study can be calculated for the situation in which the SD in the pilot study proves to be an underestimate of the true SD; and (4) an "efficient" pilot size can be determined to minimize the combined size of the pilot and main RCT. Trialists should calculate the appropriate size of a pilot study, just as they should the size of the main RCT, taking into account the twin needs to demonstrate efficiency in terms of recruitment and to produce precise estimates of treatment effect. Copyright © 2012 Elsevier Inc. All rights reserved.

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

Evidence in Practice - A Pilot Study Leveraging Companion Animal and Equine Health Data from Primary Care Veterinary Clinics in New Zealand.

PubMed

Muellner, Petra; Muellner, Ulrich; Gates, M Carolyn; Pearce, Trish; Ahlstrom, Christina; O'Neill, Dan; Brodbelt, Dave; Cave, Nick John

2016-01-01

Veterinary practitioners have extensive knowledge of animal health from their day-to-day observations of clinical patients. There have been several recent initiatives to capture these data from electronic medical records for use in national surveillance systems and clinical research. In response, an approach to surveillance has been evolving that leverages existing computerized veterinary practice management systems to capture animal health data recorded by veterinarians. Work in the United Kingdom within the VetCompass program utilizes routinely recorded clinical data with the addition of further standardized fields. The current study describes a prototype system that was developed based on this approach. In a 4-week pilot study in New Zealand, clinical data on presentation reasons and diagnoses from a total of 344 patient consults were extracted from two veterinary clinics into a dedicated database and analyzed at the population level. New Zealand companion animal and equine veterinary practitioners were engaged to test the feasibility of this national practice-based health information and data system. Strategies to ensure continued engagement and submission of quality data by participating veterinarians were identified, as were important considerations for transitioning the pilot program to a sustainable large-scale and multi-species surveillance system that has the capacity to securely manage big data. The results further emphasized the need for a high degree of usability and smart interface design to make such a system work effectively in practice. The geospatial integration of data from multiple clinical practices into a common operating picture can be used to establish the baseline incidence of disease in New Zealand companion animal and equine populations, detect unusual trends that may indicate an emerging disease threat or welfare issue, improve the management of endemic and exotic infectious diseases, and support research activities. This pilot project is an important step toward developing a national surveillance system for companion animals and equines that moves beyond emerging infectious disease detection to provide important animal health information that can be used by a wide range of stakeholder groups, including participating veterinary practices.

Overcoming the tyranny of distance: An audit of process and outcomes from a pilot telehealth spinal assessment clinic.

PubMed

Beard, Matthew; Orlando, Joseph F; Kumar, Saravana

2017-09-01

Introduction There is consistent evidence to indicate people living in rural and remote regions have limited access to healthcare and poorer health outcomes. One way to address this inequity is through innovative models of care such as telehealth. The aim of this pilot trial was to determine the feasibility, appropriateness and access to a telehealth clinic. In this pilot trial, the telehealth clinic outcomes are compared with the outreach clinic. Both models of care are commonly utilised means of providing healthcare to meet the needs of people living in rural and remote regions. Methods A prospective audit was conducted on a Spinal Assessment Clinic Telehealth pilot trial for patients with spinal disorders requiring non-urgent surgical consultation. Data were recorded from all consultations managed using videoconferencing technology between the Royal Adelaide Hospital and Port Augusta Community Health Service, South Australia between September 2013 and January 2014. Outcomes included analysis of process, service activity, clinical actions, safety and costs. Data were compared to a previous spinal assessment outreach clinic in the same area between August and December 2012. Results There were 25 consultations with 22 patients over the five-month telehealth pilot trial. Spinal disorders were predominantly of the lumbar region (88%); the majority of initial consultations (64%) were discharged to the general practitioner. There were three requests for further imaging, five for minor interventions and three for other specialist/surgical consultation. Patient follow-up post telehealth pilot trial revealed no adverse outcomes. The total cost of AUD$11,187 demonstrated a 23% reduction in favour of the spinal assessment telehealth pilot trial, with the greatest savings in travel costs. Discussion The telehealth model of care demonstrated the efficient management of patients with spinal disorders in rural regions requiring non-urgent surgical consultation at low costs with no adverse outcomes reported.

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

PubMed

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

Development and Validation of Simulated Virtual Patients to Impart Early Clinical Exposure in Endocrine Physiology

ERIC Educational Resources Information Center

Gupta, Akriti; Singh, Satendra; Khaliq, Farah; Dhaliwal, Upreet; Madhu, S. V.

2018-01-01

In the country presently, preclinical medical students are not routinely exposed to real patients. Thus, when they start clinical postings, they are found to have poor clinical reasoning skills. Simulated virtual patients (SVPs) can improve clinical skills without endangering real patients. This pilot study describes the development of two SVPs in…

Pilot Study to Evaluate the Effect of Topical Dimethicone on Clinical Signs and Skin Barrier Function in Dogs with Naturally Occurring Atopic Dermatitis

PubMed Central

Pellicoro, C.; Marsella, R.; Ahrens, K.

2013-01-01

This study investigated the effects of a skin protectant solution (dimethicone 2%) on clinical signs and skin barrier function in canine atopic dermatitis (AD). Eighteen dogs with AD were randomly divided into two groups, one received dimethicone and the other received the vehicle (cyclomethicone) on selected areas (pinnae, groin, and axillae) daily for 4 weeks. Owners and investigators were blinded regarding group allocation. Clinical efficacy was evaluated using a scoring system and skin barrier by measuring the transepidermal water loss. Twelve dogs completed the study (50% drop rate in the vehicle and 20% in the dimethicone). For clinical signs, analysis of variance showed an effect of time (P < 0.005; day 0 > day 28) and region (axillae < groin < pinnae) but no effect of group or group × time interaction. For transepidermal water loss, analysis of variance showed only a main effect of region (axillae > pinnae > groin). Pearson found no correlation between transepidermal water loss and clinical scores. In this pilot study dimethicone had no significant effect on clinical signs and transepidermal water loss in canine atopic dermatitis. PMID:23710417

Other Common Problems

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Suicide and PTSD

MedlinePlus

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Advancing and Sustaining a Clinical Teacher Preparation Partnership: An Exploratory Qualitative Case Study

ERIC Educational Resources Information Center

Garrido, Melissa Downey

2012-01-01

The national call to "turn [teacher education] upside down" (National Council for Accreditation of Teacher Education, Report of the Blue Ribbon Panel on Clinical Preparation and Partnerships for Improved Student Learning [NCATE], 2010, p. ii) and states' subsequent commitments to pilot recommendations necessitates study of successful…

Development of clinical pharmacy in Belgian hospitals through pilot projects funded by the government.

PubMed

Somers, A; Spinewine, A; Spriet, I; Steurbaut, S; Tulkens, P; Hecq, J D; Willems, L; Robays, H; Dhoore, M; Yaras, H; Vanden Bremt, I; Haelterman, M

2018-04-30

Objectives The goal is to develop clinical pharmacy in the Belgian hospitals to improve drug efficacy and to reduce drug-related problems. Methods From 2007 to 2014, financial support was provided by the Belgian federal government for the development of clinical pharmacy in Belgian hospitals. This project was guided by a national Advisory Working Group. Each funded hospital was obliged to describe yearly its clinical pharmacy activities. Results In 2007, 20 pharmacists were funded in 28 pilot hospitals; this number was doubled in 2009 to 40 pharmacists over 54 institutions, representing more than half of all acute Belgian hospitals. Most projects (72%) considered patient-related activities, whereas some projects (28%) had a hospital-wide approach. The projects targeted patients at admission (30%), during hospital stay (52%) or at discharge (18%). During hospital stay, actions were mainly focused on geriatric patients (20%), surgical patients (15%), and oncology patients (9%). Experiences, methods, and tools were shared during meetings and workshops. Structure, process, and outcome indicators were reported and strengths, weaknesses, opportunities, and threats were described. The yearly reports revealed that the hospital board was engaged in the project in 87% of the cases, and developed a vision on clinical pharmacy in 75% of the hospitals. In 2014, the pilot phase was replaced by structural financing for clinical pharmacy in all acute Belgian hospitals. Conclusion The pilot projects in clinical pharmacy funded by the federal government provided a unique opportunity to launch clinical pharmacy activities on a broad scale in Belgium. The results of the pilot projects showed clear implementation through case reports, time registrations, and indicators. Tools for clinical pharmacy activities were developed to overcome identified barriers. The engagement of hospital boards and the results of clinical pharmacy activities persuaded the government to start structural financing of clinical pharmacy.

Factors Associated With Burnout Among US Hospital Clinical Pharmacy Practitioners: Results of a Nationwide Pilot Survey.

PubMed

Jones, G Morgan; Roe, Neil A; Louden, Les; Tubbs, Crystal R

2017-12-01

Background: In health care, burnout has been defined as a psychological process whereby human service professionals attempting to positively impact the lives of others become overwhelmed and frustrated by unforeseen job stressors. Burnout among various physician groups who primarily practice in the hospital setting has been extensively studied; however, no evidence exists regarding burnout among hospital clinical pharmacists. Objective: The aim of this study was to characterize the level of and identify factors independently associated with burnout among clinical pharmacists practicing in an inpatient hospital setting within the United States. Methods: We conducted a prospective, cross-sectional pilot study utilizing an online, Qualtrics survey. Univariate analysis related to burnout was conducted, with multivariable logistic regression analysis used to identify factors independently associated with the burnout. Results: A total of 974 responses were analyzed (11.4% response rate). The majority were females who had practiced pharmacy for a median of 8 years. The burnout rate was high (61.2%) and largely driven by high emotional exhaustion. On multivariable analysis, we identified several subjective factors as being predictors of burnout, including inadequate administrative and teaching time, uncertainty of health care reform, too many nonclinical duties, difficult pharmacist colleagues, and feeling that contributions are underappreciated. Conclusions: The burnout rate of hospital clinical pharmacy providers was very high in this pilot survey. However, the overall response rate was low at 11.4%. The negative effects of burnout require further study and intervention to determine the influence of burnout on the lives of clinical pharmacists and on other health care-related outcomes.

Developing and Piloting a Form for Student Assessment of Faculty Professionalism

ERIC Educational Resources Information Center

Todhunter, Sarah; Cruess, Sylvia R.; Cruess, Richard L.; Young, Meredith; Steinert, Yvonne

2011-01-01

One of the impediments to teaching professionalism is unprofessional behavior amongst clinical teachers. No method of reliably assessing the professional behavior of clinical teachers has yet been reported. The aim of this project was to develop and pilot such a tool. Thirty-four desirable professional behaviors in clinical teachers were…

Implementing a pilot leadership course for internal medicine residents: design considerations, participant impressions, and lessons learned.

PubMed

Blumenthal, Daniel M; Bernard, Ken; Fraser, Traci N; Bohnen, Jordan; Zeidman, Jessica; Stone, Valerie E

2014-11-30

Effective clinical leadership is associated with better patient care. We implemented and evaluated a pilot clinical leadership course for second year internal medicine residents at a large United States Academic Medical Center that is part of a multi-hospital health system. The course met weekly for two to three hours during July, 2013. Sessions included large group discussions and small group reflection meetings. Topics included leadership styles, emotional intelligence, and leading clinical teams. Course materials were designed internally and featured "business school style" case studies about everyday clinical medicine which explore how leadership skills impact care delivery. Participants evaluated the course's impact and quality using a post-course survey. Questions were structured in five point likert scale and free text format. Likert scale responses were converted to a 1-5 scale (1 = strongly disagree; 3 = neither agree nor disagree; 5 = strongly agree), and means were compared to the value 3 using one-way T-tests. Responses to free text questions were analyzed using the constant comparative method. All sixteen pilot course participants completed the survey. Participants overwhelmingly agreed that the course provided content and skills relevant to their clinical responsibilities and leadership roles. Most participants also acknowledged that taking the course improved their understanding of their strengths and weaknesses as leaders, different leadership styles, and how to manage interpersonal conflict on clinical teams. 88% also reported that the course increased their interest in pursuing additional leadership training. A clinical leadership course for internal medicine residents designed by colleagues, and utilizing case studies about clinical medicine, resulted in significant self-reported improvements in clinical leadership competencies.

Virtual study groups and online Observed Structured Clinical Examinations practices - enabling trainees to enable themselves.

PubMed

Davidson, Dennisa; Evans, Lois

2018-03-01

To explore online study groups as augmentation tools in preparing for the Royal Australian and New Zealand College of Psychiatrists Observed Structured Clinical Examinations (OSCE) for fellowship. An online survey of New Zealand trainees was carried out to assess exam preparedness and openness to virtual study groups and results analysed. Relevant material around virtual study groups for fellowship examinations was reviewed and used to inform a pilot virtual study group. Four New Zealand trainees took part in the pilot project, looking at using a virtual platform to augment OSCE preparation. Of the 50 respondents 36% felt adequately prepared for the OSCE. Sixty-four per cent were interested in using a virtual platform to augment their study. Virtual study groups were noted to be especially important for rural trainees, none of whom felt able to form study groups for themselves. The pilot virtual study group was trialled successfully. All four trainees reported the experience as subjectively beneficial to their examination preparation. Virtual platforms hold promise as an augmentation strategy for exam preparation, especially for rural trainees who are more geographically isolated and less likely to have peers preparing for the same examinations.

Sexual Assault against Females

MedlinePlus

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How Common Is PTSD?

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Common Reactions After Trauma

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Issues Specific to Women

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Self-Harm and Trauma

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Men and Sexual Trauma

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Paramedic and midwifery student exposure to workplace violence during clinical placements in Australia – A pilot study

PubMed Central

McKenna, Lisa

2016-01-01

Objectives The objective of this pilot study was to identify the type of workplace violence experienced by undergraduate paramedic and midwifery students. Methods The study used a cross-sectional methodology with the self-administered paper-based Paramedic Workplace Violence Exposure Questionnaire to elicit undergraduate paramedic and midwife responses to workplace violence whilst on clinical placements. There were 393 students eligible for inclusion in the study. A convenience sample was used. The anonymous questionnaire took 10 to 20 minutes to complete. Descriptive statistics are used to summarise the data with a two-tailed t-test used to compare groups. Results The main form of workplace violence was verbal abuse 18% and intimidation 17%. There was a statistically significant difference between midwifery and paramedic students for intimidation (t(134)=-3.143, CI: -0.367 to -0.082, p=0.002) and between females and males for sexual harassment (t(134)=2.029, CI: 0.001 to 0.074, p=0.045), all other results were not statistically different. Conclusions This pilot study is the first of its kind in Australia and internationally to identify exposure rates of workplace violence by undergraduate paramedic students during clinical placements and one of very few to identify midwifery students’ exposure rates of workplace violence. The study identified that students were exposed to a range of workplace violence acts from verbal abuse through to sexual harassment. These findings highlight a need for investigation of workplace violence exposure of medical, nursing and allied health students during the clinical phase of their studies. PMID:27941182

Paramedic and midwifery student exposure to workplace violence during clinical placements in Australia - A pilot study.

PubMed

Boyle, Malcolm; McKenna, Lisa

2016-12-11

  The objective of this pilot study was to identify the type of workplace violence experienced by undergraduate paramedic and midwifery students. The study used a cross-sectional methodology with the self-administered paper-based Paramedic Workplace Violence Exposure Questionnaire to elicit undergraduate paramedic and midwife responses to workplace violence whilst on clinical placements. There were 393 students eligible for inclusion in the study. A convenience sample was used. The anonymous questionnaire took 10 to 20 minutes to complete. Descriptive statistics are used to summarise the data with a two-tailed t-test used to compare groups. The main form of workplace violence was verbal abuse 18% and intimidation 17%.  There was a statistically significant difference between midwifery and paramedic students for intimidation (t (134) =-3.143, CI: -0.367 to -0.082, p=0.002) and between females and males for sexual harassment (t (134) =2.029, CI: 0.001 to 0.074, p=0.045), all other results were not statistically different. This pilot study is the first of its kind in Australia and internationally to identify exposure rates of workplace violence by undergraduate paramedic students during clinical placements and one of very few to identify midwifery students' exposure rates of workplace violence. The study identified that students were exposed to a range of workplace violence acts from verbal abuse through to sexual harassment. These findings highlight a need for investigation of workplace violence exposure of medical, nursing and allied health students during the clinical phase of their studies.

The Psychedelic Debriefing in Alcohol Dependence Treatment: Illustrating Key Change Phenomena through Qualitative Content Analysis of Clinical Sessions

PubMed Central

Nielson, Elizabeth M.; May, Darrick G.; Forcehimes, Alyssa A.; Bogenschutz, Michael P.

2018-01-01

Research on the clinical applications of psychedelic-assisted psychotherapy has demonstrated promising early results for treatment of alcohol dependence. Detailed description of the content and methods of psychedelic-assisted psychotherapy, as it is conducted in clinical settings, is scarce. Methods: An open-label pilot (proof-of-concept) study of psilocybin-assisted treatment of alcohol dependence (NCT01534494) was conducted to generate data for a phase 2 RCT (NCT02061293) of a similar treatment in a larger population. The present paper presents a qualitative content analysis of the 17 debriefing sessions conducted in the pilot study, which occurred the day after corresponding psilocybin medication sessions. Results: Participants articulated a series of key phenomena related to change in drinking outcomes and acute subjective effects of psilocybin. Discussion: The data illuminate change processes in patients' own words during clinical sessions, shedding light on potential therapeutic mechanisms of change and how participants express effects of psilocybin. This study is unique in analyzing actual clinical sessions, as opposed to interviews of patients conducted separately from treatment. PMID:29515449

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound

PubMed Central

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-01-01

Background Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era where tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesize that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Study Design Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (Arm 1) versus SLNB (Arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Results 68 subjects were enrolled in the pilot phase of the trial (34 subjects in Arm 1, no further staging; 32 subjects in Arm 2, SLNB, and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40-80) in Arm 1 and 59 years (range 31-81) in Arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1-32). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (> 2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Conclusions Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. PMID:27212005

Autoantibodies to nervous system-specific proteins are elevated in sera of flight crew members: biomarkers for nervous system injury.

PubMed

Abou-Donia, Mohamed B; Abou-Donia, Martha M; ElMasry, Eman M; Monro, Jean A; Mulder, Michel F A

2013-01-01

This descriptive study reports the results of assays performed to detect circulating autoantibodies in a panel of 7 proteins associated with the nervous system (NS) in sera of 12 healthy controls and a group of 34 flight crew members including both pilots and attendants who experienced adverse effects after exposure to air emissions sourced to the ventilation system in their aircrafts and subsequently sought medical attention. The proteins selected represent various types of proteins present in nerve cells that are affected by neuronal degeneration. In the sera samples from flight crew members and healthy controls, immunoglobin (IgG) was measured using Western blotting against neurofilament triplet proteins (NFP), tubulin, microtubule-associated tau proteins (tau), microtubule-associated protein-2 (MAP-2), myelin basic protein (MBP), glial fibrillary acidic protein (GFAP), and glial S100B protein. Significant elevation in levels of circulating IgG-class autoantibodies in flight crew members was found. A symptom-free pilot was sampled before symptoms and then again afterward. This pilot developed clinical problems after flying for 45 h in 10 d. Significant increases in autoantibodies were noted to most of the tested proteins in the serum of this pilot after exposure to air emissions. The levels of autoantibodies rose with worsening of his condition compared to the serum sample collected prior to exposure. After cessation of flying for a year, this pilot's clinical condition improved, and eventually he recovered and his serum autoantibodies against nervous system proteins decreased. The case study with this pilot demonstrates a temporal relationship between exposure to air emissions, clinical condition, and level of serum autoantibodies to nervous system-specific proteins. Overall, these results suggest the possible development of neuronal injury and gliosis in flight crew members anecdotally exposed to cabin air emissions containing organophosphates. Thus, increased circulating serum autoantibodies resulting from neuronal damage may be used as biomarkers for chemical-induced CNS injury.

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

PubMed

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

2015-01-01

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

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

PubMed Central

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

2015-01-01

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

Collagen content as a risk factor in breast cancer? A pilot clinical study

NASA Astrophysics Data System (ADS)

Pifferi, Antonio; Quarto, Giovanna; Abbate, Francesca; Balestreri, Nicola; Menna, Simona; Cassano, Enrico; Cubeddu, Rinaldo; Taroni, Paola

2015-07-01

A retrospective pilot clinical study on time domain multi-wavelength (635 to 1060 nm) optical mammography was exploited to assess collagen as a breast-cancer risk factor on a total of 109 subjects (53 healthy and 56 with malignant lesions). An increased cancer occurrence is observed on the 15% subset of patients with higher age-matched collagen content. Further, a similar clustering based on the percentage breast density leads to a different set of patients, possibly indicating collagen as a new independent breast cancer risk factor. If confirmed statistically and on larger numbers, these results could have huge impact on personalized diagnostics, health care systems, as well as on basic research.

Effects of PTSD on Family

MedlinePlus

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Electronic problem-solving treatment: description and pilot study of an interactive media treatment for depression.

PubMed

Cartreine, James Albert; Locke, Steven E; Buckey, Jay C; Sandoval, Luis; Hegel, Mark T

2012-09-25

Computer-automated depression interventions rely heavily on users reading text to receive the intervention. However, text-delivered interventions place a burden on persons with depression and convey only verbal content. The primary aim of this project was to develop a computer-automated treatment for depression that is delivered via interactive media technology. By using branching video and audio, the program simulates the experience of being in therapy with a master clinician who provides six sessions of problem-solving therapy. A secondary objective was to conduct a pilot study of the program's usability, acceptability, and credibility, and to obtain an initial estimate of its efficacy. The program was produced in a professional multimedia production facility and incorporates video, audio, graphics, animation, and text. Failure analyses of patient data are conducted across sessions and across problems to identify ways to help the user improve his or her problem solving. A pilot study was conducted with persons who had minor depression. An experimental group (n = 7) used the program while a waitlist control group (n = 7) was provided with no treatment for 6 weeks. All of the experimental group participants completed the trial, whereas 1 from the control was lost to follow-up. Experimental group participants rated the program high on usability, acceptability, and credibility. The study was not powered to detect clinical improvement, although these pilot data are encouraging. Although the study was not powered to detect treatment effects, participants did find the program highly usable, acceptable, and credible. This suggests that the highly interactive and immersive nature of the program is beneficial. Further clinical trials are warranted. ClinicalTrials.gov NCT00906581; http://clinicaltrials.gov/ct2/show/NCT00906581 (Archived by WebCite at http://www.webcitation.org/6A5Ni5HUp).

Single-cell genomic profiling of acute myeloid leukemia for clinical use: A pilot study

PubMed Central

Yan, Benedict; Hu, Yongli; Ban, Kenneth H.K.; Tiang, Zenia; Ng, Christopher; Lee, Joanne; Tan, Wilson; Chiu, Lily; Tan, Tin Wee; Seah, Elaine; Ng, Chin Hin; Chng, Wee-Joo; Foo, Roger

2017-01-01

Although bulk high-throughput genomic profiling studies have led to a significant increase in the understanding of cancer biology, there is increasing awareness that bulk profiling approaches do not completely elucidate tumor heterogeneity. Single-cell genomic profiling enables the distinction of tumor heterogeneity, and may improve clinical diagnosis through the identification and characterization of putative subclonal populations. In the present study, the challenges associated with a single-cell genomics profiling workflow for clinical diagnostics were investigated. Single-cell RNA-sequencing (RNA-seq) was performed on 20 cells from an acute myeloid leukemia bone marrow sample. Putative blasts were identified based on their gene expression profiles and principal component analysis was performed to identify outlier cells. Variant calling was performed on the single-cell RNA-seq data. The present pilot study demonstrates a proof of concept for clinical single-cell genomic profiling. The recognized limitations include significant stochastic RNA loss and the relatively low throughput of the current proposed platform. Although the results of the present study are promising, further technological advances and protocol optimization are necessary for single-cell genomic profiling to be clinically viable. PMID:28454300

PTSD and Problems with Alcohol Use

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Effects of Disasters: Risk and Resilience Factors

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Assessing research impact in academic clinical medicine: a study using Research Excellence Framework pilot impact indicators

PubMed Central

2012-01-01

Background Funders of medical research the world over are increasingly seeking, in research assessment, to complement traditional output measures of scientific publications with more outcome-based indicators of societal and economic impact. In the United Kingdom, the Higher Education Funding Council for England (HEFCE) developed proposals for the Research Excellence Framework (REF) to allocate public research funding to higher education institutions, inter alia, on the basis of the social and economic impact of their research. In 2010, it conducted a pilot exercise to test these proposals and refine impact indicators and criteria. Methods The impact indicators proposed in the 2010 REF impact pilot exercise are critically reviewed and appraised using insights from the relevant literature and empirical data collected for the University of Oxford’s REF pilot submission in clinical medicine. The empirical data were gathered from existing administrative sources and an online administrative survey carried out by the university’s Medical Sciences Division among 289 clinical medicine faculty members (48.1% response rate). Results The feasibility and scope of measuring research impact in clinical medicine in a given university are assessed. Twenty impact indicators from seven categories proposed by HEFCE are presented; their strengths and limitations are discussed using insights from the relevant biomedical and research policy literature. Conclusions While the 2010 pilot exercise has confirmed that the majority of the proposed indicators have some validity, there are significant challenges in operationalising and measuring these indicators reliably, as well as in comparing evidence of research impact across different cases in a standardised manner. It is suggested that the public funding agencies, medical research charities, universities, and the wider medical research community work together to develop more robust methodologies for capturing and describing impact, including more valid and reliable impact indicators. PMID:23259467

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors.

PubMed

Elkins, Gary; Marcus, Joel; Stearns, Vered; Hasan Rajab, M

2007-05-01

This single arm, pilot study investigated the use of hypnosis to reduce hot flashes in 16 breast cancer survivors. Each patient provided baseline data and received 4 weekly sessions of hypnosis that followed a standardized transcript. Patients were also instructed in self-hypnosis. Throughout the clinical care, patients completed daily diaries of the frequency and severity of their hot flashes. Patients also completed baseline and post-treatment ratings of the degree to which hot flashes interfered with daily activities and quality of life. Results indicated a 59% decrease in total daily hot flashes and a 70% decrease in weekly hot flash scores from their baselines. There was also a significant decrease in the degree to which hot flashes interfered with daily activities for all measures including work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life, and overall quality of life. This pilot study suggests that clinical hypnosis may be an effective non-hormonal and non-pharmacological treatment for hot flashes. A randomized, controlled clinical trial is planned to more definitively elucidate the efficacy and applicability of hypnosis for reducing hot flashes.

Simulation debriefing based on principles of transfer of learning: A pilot study.

PubMed

Johnston, Sandra; Coyer, Fiona; Nash, Robyn

2017-09-01

Upon completion of undergraduate nursing courses, new graduates are expected to transition seamlessly into practice. Education providers face challenges in the preparation of undergraduate nurses due to increasing student numbers and decreasing availability of clinical placement sites. High fidelity patient simulation is an integral component of nursing curricula as an adjunct to preparation for clinical placement. Debriefing after simulation is an area where the underlying structure of problems can consciously be explored. When central principles of problems are identified, they can then be used in situations that differ from the simulation experience. Third year undergraduate nursing students participated in a pilot study conducted to test a debriefing intervention where the intervention group (n=7) participated in a simulation, followed by a debriefing based on transfer of learning principles. The control group (n=5) participated in a simulation of the same scenario, followed by a standard debriefing. Students then attended focus group interviews. The results of this pilot test provided preliminary information that the debriefing approach based on transfer of learning principles may be a useful way for student nurses to learn from a simulated experience and consider the application of learning to future clinical encounters. Copyright © 2017 Elsevier Ltd. All rights reserved.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

Are large clinical trials in orthopaedic trauma justified?

PubMed

Sprague, Sheila; Tornetta, Paul; Slobogean, Gerard P; O'Hara, Nathan N; McKay, Paula; Petrisor, Brad; Jeray, Kyle J; Schemitsch, Emil H; Sanders, David; Bhandari, Mohit

2018-04-20

The objective of this analysis is to evaluate the necessity of large clinical trials using FLOW trial data. The FLOW pilot study and definitive trial were factorial trials evaluating the effect of different irrigation solutions and pressures on re-operation. To explore treatment effects over time, we analyzed data from the pilot and definitive trial in increments of 250 patients until the final sample size of 2447 patients was reached. At each increment we calculated the relative risk (RR) and associated 95% confidence interval (CI) for the treatment effect, and compared the results that would have been reported at the smaller enrolments with those seen in the final, adequately powered study. The pilot study analysis of 89 patients and initial incremental enrolments in the FLOW definitive trial favored low pressure compared to high pressure (RR: 1.50, 95% CI: 0.75-3.04; RR: 1.39, 95% CI: 0.60-3.23, respectively), which is in contradiction to the final enrolment, which found no difference between high and low pressure (RR: 1.04, 95% CI: 0.81-1.33). In the soap versus saline comparison, the FLOW pilot study suggested that re-operation rate was similar in both the soap and saline groups (RR: 0.98, 95% CI: 0.50-1.92), whereas the FLOW definitive trial found that the re-operation rate was higher in the soap treatment arm (RR: 1.28, 95% CI: 1.04-1.57). Our findings suggest that studies with smaller sample sizes would have led to erroneous conclusions in the management of open fracture wounds. NCT01069315 (FLOW Pilot Study) Date of Registration: February 17, 2010, NCT00788398 (FLOW Definitive Trial) Date of Registration: November 10, 2008.

Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

PubMed Central

Dobkin, Bruce H.

2014-01-01

Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

Methodology of clinical research in rare diseases: development of a research program in juvenile neuronal ceroid lipofuscinosis (JNCL) via creation of a patient registry and collaboration with patient advocates

PubMed Central

de Blieck, Elisabeth A.; Augustine, Erika F.; Marshall, Frederick J.; Adams, Heather; Cialone, Jennifer; Dure, Leon; Kwon, Jennifer M.; Newhouse, Nicole; Rose, Katherine; Rothberg, Paul G.; Vierhile, Amy; Mink, Jonathan W.

2013-01-01

Introduction Juvenile neuronal ceroid lipofuscinosis (JNCL; Batten disease) is a rare, inherited, fatal lysosomal storage childhood disorder. True for many rare diseases, there are no treatments that impact the course of JNCL. The University of Rochester Batten Center’s (URBC) mission is to find treatments to slow, halt, or prevent JNCL. Objectives Our initial objective was to develop clinical research infrastructure preparatory to clinical trials, establish a JNCL research cohort, construct a disease-specific clinical outcome measure, and validate a non-invasive diagnostic sampling method. The long-term objective is to design and implement JNCL clinical trials. Methods The Unified Batten Disease Rating Scale (UBDRS) was developed. The Batten Disease Support and Research Association (BDSRA) referred participants; annual BDSRA meetings provided a mobile research setting for registry enrollment and UBDRS piloting. Neuropsychological examinations were performed, enabling external validation of the UBDRS. Buccal epithelial cell collection for genotyping was introduced. Telemedicine for remote UBDRS assessment was piloted. Results The registry enrolled 198 families representing 237 children with NCL. The UBDRS was piloted, validated and has been used to collect natural history data from 120 subjects. Funding and regulatory approval were obtained for a recently launched phase II clinical trial. Several additional lines of inquiry were reported. Conclusion The registry and BDSRA collaboration have enabled development of a clinical rating scale, natural history and neuropsychological studies, and genetic studies for disease confirmation. This work highlights an approach for preparatory natural history research and infrastructure development needed to facilitate efficient implementation of clinical trials in rare diseases. PMID:23628560

Managing Depression Among Homeless Mothers: Pilot Testing an Adapted Collaborative Care Intervention.

PubMed

Weinreb, Linda; Upshur, Carole C; Fletcher-Blake, Debbian; Reed, George; Frisard, Christine

2016-01-01

Although depression is common among homeless mothers, little progress has been made in testing treatment strategies for this group. We describe pilot test results of an adapted collaborative care model for homeless mothers with depression. We conducted a pilot intervention study of mothers screening positive for depression in 2 randomly selected shelter-based primary care clinics in New York over 18 months in 2010-2012. Study participants completed a psychosocial, health, and mental health assessment at baseline, 3 months, and 6 months. One-third of women screened positive for depression (123 of 328 women). Sixty-seven women (63.2% of the eligible sample) enrolled in the intervention. At 6 months, compared to usual-care women, intervention group women were more likely to be receiving depression treatment (40.0% vs 5.9%, P = .01) and antidepressant medication (73.3% vs 5.9%, P = .001, respectively) and had more primary care physician and care manager visits at both 3 months (74.3% vs 53.3%, P = .009 and 91.4% vs 26.7%, P < .001, respectively) and 6 months (46.7% vs 23.5%, P = .003 and 70% vs 17.7%, P = .001, respectively). More women in the intervention group compared to usual-care women reported ≥ 50% improvement in depression symptoms at 6 months (30% vs 5.9%, P = .07). This pilot study found that implementing an adapted collaborative care intervention was feasible in a shelter-based primary care clinic and had promising results that require further testing. ClinicalTrials.gov identifier: NCT02723058.

Pilot study of atomoxetine in patients with Parkinson's disease and dopa-unresponsive Freezing of Gait.

PubMed

Revuelta, Gonzalo J; Embry, Aaron; Elm, Jordan J; Gregory, Chris; Delambo, Amy; Kautz, Steve; Hinson, Vanessa K

2015-01-01

Freezing of gait (FoG) is a common and debilitating condition in Parkinson's disease (PD) associated with executive dysfunction. A subtype of FoG does not respond to dopaminergic therapy and may be related to noradrenergic deficiency. This pilot study explores the effects of atomoxetine on gait in PD patients with dopa-unresponsive FoG using a novel paradigm for objective gait assessment. Ten patients with PD and dopa-unresponsive FoG were enrolled in this eight-week open label pilot study. Assessments included an exploratory gait analysis protocol that quantified spatiotemporal parameters during straight-away walking and turning, while performing a dual task. Clinical, and subjective assessments of gait, quality of life, and safety were also administered. The primary outcome was a validated subjective assessment for FoG (FOG-Q). Atomoxetine was well tolerated, however, no significant change was observed in the primary outcome. The gait analysis protocol correlated well with clinical scales, but not with subjective assessments. DBS patients were more likely to increase gait velocity (p = 0.033), and improved in other clinical assessments. Objective gait analysis protocols assessing gait while dual tasking are feasible and useful for this patient population, and may be superior correlates of FoG severity than subjective measures. These findings can inform future trials in this population.

Chronic Pain and PTSD: A Guide for Patients

MedlinePlus

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Medical students as teachers at CoSMO, Columbia University's student-run clinic: a pilot study and literature review.

PubMed

Hamso, Magni; Ramsdell, Amanda; Balmer, Dorene; Boquin, Cyrus

2012-01-01

Although medical students are expected to teach as soon as they begin residency, medical schools have just recently begun adding teacher training to their curricula. Student-run clinics (SRCs) may provide opportunities in clinical teaching before residency. The aim of this pilot study was to examine students' experiences in clinical teaching at Columbia Student Medical Outreach (CoSMO), Columbia University's SRC, during the 2009-2010 school year. A mixed-methods approach was used. Data included closed and open-ended surveys (n = 34), combined interviews with preclinical and clinical student pairs (n = 5), individual interviews (n = 10), and focus groups (n = 3). The transcripts were analyzed using the principles of grounded theory. Many students had their first clinical teaching experience while volunteering at CoSMO. Clinical students' ability to teach affected the quality of the learning experience for their preclinical peers. Preclinical students who asked questions and engaged in patient care challenged their clinical peers to balance teaching with patient care. Clinical students began to see themselves as teachers while volunteering at CoSMO. The practical experiences in clinical teaching that students have at SRCs can supplement classroom-based trainings. Medical schools might revisit their SRCs as places for exposure to clinical teaching.

75 FR 4092 - Center for Scientific Review; Notice of Closed Meetings

Federal Register 2010, 2011, 2012, 2013, 2014

2010-01-26

...: Alzheimer's Disease Pilot Clinical Trials. Date: February 24, 2010. Time: 4 p.m. to 6 p.m. Agenda: To review... personal privacy. Name of Committee: Infectious Diseases and Microbiology Integrated Review Group, Clinical Research and Field Studies of Infectious Diseases Study Section. Date: February 15, 2010. Time: 8 a.m. to 6...

Plasma Metabolites Predict Severity of Depression and Suicidal Ideation in Psychiatric Patients-A Multicenter Pilot Analysis.

PubMed

Setoyama, Daiki; Kato, Takahiro A; Hashimoto, Ryota; Kunugi, Hiroshi; Hattori, Kotaro; Hayakawa, Kohei; Sato-Kasai, Mina; Shimokawa, Norihiro; Kaneko, Sachie; Yoshida, Sumiko; Goto, Yu-Ichi; Yasuda, Yuka; Yamamori, Hidenaga; Ohgidani, Masahiro; Sagata, Noriaki; Miura, Daisuke; Kang, Dongchon; Kanba, Shigenobu

2016-01-01

Evaluating the severity of depression (SOD), especially suicidal ideation (SI), is crucial in the treatment of not only patients with mood disorders but also psychiatric patients in general. SOD has been assessed on interviews such as the Hamilton Rating Scale for Depression (HAMD)-17, and/or self-administered questionnaires such as the Patient Health Questionnaire (PHQ)-9. However, these evaluation systems have relied on a person's subjective information, which sometimes lead to difficulties in clinical settings. To resolve this limitation, a more objective SOD evaluation system is needed. Herein, we collected clinical data including HAMD-17/PHQ-9 and blood plasma of psychiatric patients from three independent clinical centers. We performed metabolome analysis of blood plasma using liquid chromatography mass spectrometry (LC-MS), and 123 metabolites were detected. Interestingly, five plasma metabolites (3-hydroxybutyrate (3HB), betaine, citrate, creatinine, and gamma-aminobutyric acid (GABA)) are commonly associated with SOD in all three independent cohort sets regardless of the presence or absence of medication and diagnostic difference. In addition, we have shown several metabolites are independently associated with sub-symptoms of depression including SI. We successfully created a classification model to discriminate depressive patients with or without SI by machine learning technique. Finally, we produced a pilot algorithm to predict a grade of SI with citrate and kynurenine. The above metabolites may have strongly been associated with the underlying novel biological pathophysiology of SOD. We should explore the biological impact of these metabolites on depressive symptoms by utilizing a cross species study model with human and rodents. The present multicenter pilot study offers a potential utility for measuring blood metabolites as a novel objective tool for not only assessing SOD but also evaluating therapeutic efficacy in clinical practice. In addition, modification of these metabolites by diet and/or medications may be a novel therapeutic target for depression. To clarify these aspects, clinical trials measuring metabolites before/after interventions should be conducted. Larger cohort studies including non-clinical subjects are also warranted to clarify our pilot findings.

Effects of malicious ocular laser exposure in commercial airline pilots.

PubMed

Palakkamanil, Mathew M; Fielden, Michael P

2015-12-01

Intentional malicious laser strikes on commercial pilots are committed by individuals who target a laser into airplane cockpits during takeoff and landing. Because laser exposure to pilots is a relatively new but growing occurrence, our study investigates the ocular effect of this laser exposure in pilots. Retrospective chart review by a single ophthalmologist. All commercial airline pilots (58 male, 3 female) who experienced a laser strike while flying between April 2012 and November 2014 who presented to our clinic were included. A retrospective chart review was performed in a retinal specialist's practice. Ocular assessment was performed within 3 days of laser exposure. A complete ophthalmic evaluation was conducted, including Early Treatment Diabetic Retinopathy Study visual acuity, colour vision, visual fields, intraocular pressure, slit-lamp examination, dilated fundus examination, colour fundus photographs, and ocular coherence tomography. Sixty-four laser strike incidents involving commercial pilots were included. All pilots in the study experienced some degree of immediate ocular irritation or light sensitivity. No definite cases of ocular damage were attributed to laser strikes. No pilot had any functional ocular deficits. Our study revealed that laser strikes on aircraft did not result in permanent visual functional or structural deficits. However, laser strikes cause immediate visual effects, including glare, flash blindness, and ocular irritation that can interfere with a pilot's visual function. Given the widespread accessibility of high-power lasers and the rapid increase in incidents, laser strikes threaten to jeopardize aviation safety unless effective preventative measures are put in place. Copyright © 2015 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

A Pilot Study of Contextual UMLS Indexing to Improve the Precision of Concept-based Representation in XML-structured Clinical Radiology Reports

PubMed Central

Huang, Yang; Lowe, Henry J.; Hersh, William R.

2003-01-01

Objective: Despite the advantages of structured data entry, much of the patient record is still stored as unstructured or semistructured narrative text. The issue of representing clinical document content remains problematic. The authors' prior work using an automated UMLS document indexing system has been encouraging but has been affected by the generally low indexing precision of such systems. In an effort to improve precision, the authors have developed a context-sensitive document indexing model to calculate the optimal subset of UMLS source vocabularies used to index each document section. This pilot study was performed to evaluate the utility of this indexing approach on a set of clinical radiology reports. Design: A set of clinical radiology reports that had been indexed manually using UMLS concept descriptors was indexed automatically by the SAPHIRE indexing engine. Using the data generated by this process the authors developed a system that simulated indexing, at the document section level, of the same document set using many permutations of a subset of the UMLS constituent vocabularies. Measurements: The precision and recall scores generated by simulated indexing for each permutation of two or three UMLS constituent vocabularies were determined. Results: While there was considerable variation in precision and recall values across the different subtypes of radiology reports, the overall effect of this indexing strategy using the best combination of two or three UMLS constituent vocabularies was an improvement in precision without significant impact of recall. Conclusion: In this pilot study a contextual indexing strategy improved overall precision in a set of clinical radiology reports. PMID:12925544

A pilot study of contextual UMLS indexing to improve the precision of concept-based representation in XML-structured clinical radiology reports.

PubMed

Huang, Yang; Lowe, Henry J; Hersh, William R

2003-01-01

Despite the advantages of structured data entry, much of the patient record is still stored as unstructured or semistructured narrative text. The issue of representing clinical document content remains problematic. The authors' prior work using an automated UMLS document indexing system has been encouraging but has been affected by the generally low indexing precision of such systems. In an effort to improve precision, the authors have developed a context-sensitive document indexing model to calculate the optimal subset of UMLS source vocabularies used to index each document section. This pilot study was performed to evaluate the utility of this indexing approach on a set of clinical radiology reports. A set of clinical radiology reports that had been indexed manually using UMLS concept descriptors was indexed automatically by the SAPHIRE indexing engine. Using the data generated by this process the authors developed a system that simulated indexing, at the document section level, of the same document set using many permutations of a subset of the UMLS constituent vocabularies. The precision and recall scores generated by simulated indexing for each permutation of two or three UMLS constituent vocabularies were determined. While there was considerable variation in precision and recall values across the different subtypes of radiology reports, the overall effect of this indexing strategy using the best combination of two or three UMLS constituent vocabularies was an improvement in precision without significant impact of recall. In this pilot study a contextual indexing strategy improved overall precision in a set of clinical radiology reports.

Training oncology and palliative care clinical nurse specialists in psychological skills: evaluation of a pilot study.

PubMed

Clark, Jane E; Aitken, Susan; Watson, Nina; McVey, Joanne; Helbert, Jan; Wraith, Anita; Taylor, Vanessa; Catesby, Sarah

2015-06-01

National guidelines in the United Kingdom recommend training Clinical Nurse Specialists in psychological skills to improve the assessment and intervention with psychological problems experienced by people with a cancer diagnosis (National Institute for Health and Clinical Excellence, 2004). This pilot study evaluated a three-day training program combined with supervision sessions from Clinical Psychologists that focused on developing skills in psychological assessment and intervention for common problems experienced by people with cancer. Questionnaires were developed to measure participants' levels of confidence in 15 competencies of psychological skills. Participants completed these prior to the program and on completion of the program. Summative evaluation was undertaken and results were compared. In addition, a focus group interview provided qualitative data of participants' experiences of the structure, process, and outcomes of the program. Following the program, participants rated their confidence in psychological assessment and skills associated with providing psychological support as having increased in all areas. This included improved knowledge of psychological theories, skills in assessment and intervention and accessing and using supervision appropriately. The largest increase was in providing psycho-education to support the coping strategies of patients and carers. Thematic analysis of interview data identified two main themes including learning experiences and program enhancements. The significance of the clinical supervision sessions as key learning opportunities, achieved through the development of a community of practice, emerged. Although this pilot study has limitations, the results suggest that a combined teaching and supervision program is effective in improving Clinical Nurse Specialists' confidence level in specific psychological skills. Participants' experiences highlighted suggestions for refinement and development of the program. Opportunities for further research and developments in this area are discussed.

Using pilot data to size a two-arm randomized trial to find a nearly optimal personalized treatment strategy.

PubMed

Laber, Eric B; Zhao, Ying-Qi; Regh, Todd; Davidian, Marie; Tsiatis, Anastasios; Stanford, Joseph B; Zeng, Donglin; Song, Rui; Kosorok, Michael R

2016-04-15

A personalized treatment strategy formalizes evidence-based treatment selection by mapping patient information to a recommended treatment. Personalized treatment strategies can produce better patient outcomes while reducing cost and treatment burden. Thus, among clinical and intervention scientists, there is a growing interest in conducting randomized clinical trials when one of the primary aims is estimation of a personalized treatment strategy. However, at present, there are no appropriate sample size formulae to assist in the design of such a trial. Furthermore, because the sampling distribution of the estimated outcome under an estimated optimal treatment strategy can be highly sensitive to small perturbations in the underlying generative model, sample size calculations based on standard (uncorrected) asymptotic approximations or computer simulations may not be reliable. We offer a simple and robust method for powering a single stage, two-armed randomized clinical trial when the primary aim is estimating the optimal single stage personalized treatment strategy. The proposed method is based on inverting a plugin projection confidence interval and is thereby regular and robust to small perturbations of the underlying generative model. The proposed method requires elicitation of two clinically meaningful parameters from clinical scientists and uses data from a small pilot study to estimate nuisance parameters, which are not easily elicited. The method performs well in simulated experiments and is illustrated using data from a pilot study of time to conception and fertility awareness. Copyright © 2015 John Wiley & Sons, Ltd.

Electronic protocol of respiratory physical therapy in patients with idiopathic adolescent scoliosis.

PubMed

Cano, Danila Vieira Baldini; Malafaia, Osvaldo; Alves, Vera Lúcia dos Santos; Avanzi, Osmar; Pinto, José Simão de Paula

2011-01-01

To create a clinical database of respiratory function in patients with adolescent idiopathic scoliosis; computerize and store this clinical data through the use of a software; incorporate this electronic protocol to the SINPE© (Integrated Electronic Protocols System) and analyze a pilot project with interpretation of results. From the literature review a computerized data bank of clinical data of postural deviations was set up (master protocol). Upon completion of the master protocol a specific protocol of respiratory function in patients with adolescent idiopathic scoliosis was designed and a pilot project was conducted to collect and analyze data from ten patients. It was possible to create the master protocol of postural deviations and the specific protocol of respiratory function in patients with adolescent idiopathic scoliosis. The data collected in the pilot project was processed by the SINPE ANALYZER©, generating charts and statistics. The establishment of the clinical database of adolescent idiopathic scoliosis was possible. Computerization and storage of clinical data using the software were viable. The electronic protocol of adolescent idiopathic scoliosis could be incorporated into the SINPE© and its use in the pilot project was successful.

Data Quality and Interoperability Challenges for eHealth Exchange Participants: Observations from the Department of Veterans Affairs' Virtual Lifetime Electronic Record Health Pilot Phase.

PubMed

Botts, Nathan; Bouhaddou, Omar; Bennett, Jamie; Pan, Eric; Byrne, Colene; Mercincavage, Lauren; Olinger, Lois; Hunolt, Elaine; Cullen, Theresa

2014-01-01

Authors studied the United States (U.S.) Department of Veterans Affairs' (VA) Virtual Lifetime Electronic Record (VLER) Health pilot phase relative to two attributes of data quality - the adoption of eHealth Exchange data standards, and clinical content exchanged. The VLER Health pilot was an early effort in testing implementation of eHealth Exchange standards and technology. Testing included evaluation of exchange data from the VLER Health pilot sites partners: VA, U.S. Department of Defense (DoD), and private sector health care organizations. Domains assessed data quality and interoperability as it relates to: 1) conformance with data standards related to the underlying structure of C32 Summary Documents (C32) produced by eHealth Exchange partners; and 2) the types of C32 clinical content exchanged. This analysis identified several standards non-conformance issues in sample C32 files and informed further discourse on the methods needed to effectively monitor Health Information Exchange (HIE) data content and standards conformance.

What Can I Do If I Think I Have PTSD?

MedlinePlus

... VA for Vets Performance Based Interviewing Clinical Trainees (Academic Affiliations) Employees & Contractors Talent Management System (TMS) VA ... stress. Search Pilots Search PILOTS *, the largest citation database on PTSD. What is PILOTS? Subscribe Sign up ...

PTSD Treatment Programs in the U.S. Department of Veterans Affairs

MedlinePlus

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The impact of inclusion criteria in health economic assessments.

PubMed

Richter, Anke; Thieda, Patricia; Thaler, Kylie; Gartlehner, Gerald

2011-05-01

The debate surrounding whether the findings of efficacy studies are applicable to real-world treatment situations is ongoing. The issue of lack of applicability due to a lack of clinical heterogeneity could be addressed by employing less restrictive inclusion criteria. Given that health economic assessments based on cost-effectiveness measures are required by many governments and insurance providers, the impact of this choice may be far reaching. The objective of this article was to explore the use of a pilot study to examine the impact of inclusion criteria on cost-effectiveness results and clinical heterogeneity. A health economic assessment was conducted using QRISK®2 and simulation modelling of different population groups within the pilot study in Lower Austria. Patients were referred by their family physicians to 'Active Prevention' (Vorsorge Aktiv), a community-based lifestyle intervention focused on exercise and nutritional programmes. Cardiovascular risk factors were recorded before and after the intervention and translated to cardiovascular events. As expected, enforcing restrictive inclusion criteria produced stronger and more irrefutable computations - in the expected number of events, the number of deaths, the incremental cost per life-year saved and in the 95% confidence interval. These findings provide insight into the issues surrounding clinical heterogeneity and the need for restrictive inclusion criteria. This is not a full health economic assessment of the intervention. While inclusion criteria provide stronger results by limiting populations to those who would benefit the most, they must be enforced, both within and outside the clinical trial setting. Enforcement has costs, both monetary and arising from unintended negative consequences of enforcement mechanisms. All these considerations will affect the results realized by the payer organization. A pilot study can reveal whether an intervention may be cost effective 'enough' without restrictive inclusion criteria and can enable researchers to search for population subgroups in which the intervention remains cost effective. When the pilot study does not indicate sufficiently strong cost-effectiveness results, the broader trade-offs between clinical heterogeneity and the strength of the submission package to the reimbursement agency can be discussed by all parties. Payer concerns about the ability to generalize the results beyond the clinical trial can also be discussed at this time. Applicability then depends on the ability to enforce inclusion criteria similar to those used in the trials in the real world.

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Treatment of Aspergillus fumigatus in patients with cystic fibrosis: a randomized, placebo-controlled pilot study.

PubMed

Aaron, Shawn D; Vandemheen, Katherine L; Freitag, Andreas; Pedder, Linda; Cameron, William; Lavoie, Annick; Paterson, Nigel; Wilcox, Pearce; Rabin, Harvey; Tullis, Elizabeth; Morrison, Nancy; Ratjen, Felix

2012-01-01

Many patients with cystic fibrosis develop persistent airway infection/colonization with Aspergillus fumigatus, however the impact of A. fumigatus on clinical outcomes remains unclear. The objective of this study was to determine whether treatment directed against Aspergillus fumigatus improves pulmonary function and clinical outcomes in patients with cystic fibrosis (CF). We performed a double-blind randomized placebo-controlled pilot clinical trial involving 35 patients with CF whose sputum cultures were chronically positive for A. fumigatus. Participants were centrally randomized to receive either oral itraconazole 5 mg/kg/d (N = 18) or placebo (N = 17) for 24 weeks. The primary outcome was the proportion of patients who experienced a respiratory exacerbation requiring intravenous antibiotics over the 24 week treatment period. Secondary outcomes included changes in FEV(1) and quality of life. Over the 24 week treatment period, 4 of 18 (22%) patients randomized to itraconazole experienced a respiratory exacerbation requiring intravenous antibiotics, compared to 5 of 16 (31%) placebo treated patients, P = 0.70. FEV(1) declined by 4.62% over 24 weeks in the patients randomized to itraconazole, compared to a 0.32% improvement in the placebo group (between group difference = -4.94%, 95% CI: -15.33 to 5.45, P = 0.34). Quality of life did not differ between the 2 treatment groups throughout the study. Therapeutic itraconazole blood levels were not achieved in 43% of patients randomized to itraconazole. We did not identify clinical benefit from itraconazole treatment for CF patients whose sputum was chronically colonized with A. fumigatus. Limitations of this pilot study were its small sample size, and failure to achieve therapeutic levels of itraconazole in many patients. ClinicalTrials.gov NCT00528190.

Clinical variables and implications of the personality on the outcome of bipolar illness: a pilot study

PubMed Central

Casas-Barquero, Nieves; García-López, Olga; Fernández-Argüelles, Pedro; Camacho-Laraña, Manuel

2007-01-01

Outcome in bipolar patients is affected by comorbidity. Comorbid personality disorders are frequent and may complicate the course of bipolar illness. This pilot study examined a series of 40 euthymic bipolar patients (DSM-IV criteria) (bipolar I disorder 31, bipolar II disorder 9) to assess the effect of clinical variables and the influence of comorbid personality on the clinical course of bipolar illness. Bipolar patients with a diagnosis of comorbid personality disorder (n = 30) were compared with “pure” bipolar patients (n = 10) with regard to demographic, clinical, and course of illness variables. Comorbid personality disorder was diagnosed in 75% of patients according to ICD-10 criteria, with obsessive-compulsive personality disorder being the most frequent type. Sixty-three per cent of subjects had more than one comorbid personality disorder. Bipolar patients with and without comorbid personality disorder showed no significant differences regarding features of the bipolar illness, although the group with comorbid personality disorder showed a younger age at onset, more depressive episodes, and longer duration of bipolar illness. In subjects with comorbid personality disorders, the number of hospitalizations correlated significantly with depressive episodes and there was an inverse correlation between age at the first episode and duration of bipolar illness. These findings, however, should be interpreted taking into account the preliminary nature of a pilot study and the contamination of the sample with too many bipolar II patients. PMID:19300559

The clinical outcome and microbiological profile of bone-anchored hearing systems (BAHS) with different abutment topographies: a prospective pilot study.

PubMed

Trobos, Margarita; Johansson, Martin Lars; Jonhede, Sofia; Peters, Hanna; Hoffman, Maria; Omar, Omar; Thomsen, Peter; Hultcrantz, Malou

2018-06-01

In this prospective clinical pilot study, abutments with different topologies (machined versus polished) were compared with respect to the clinical outcome and the microbiological profile. Furthermore, three different sampling methods (retrieval of abutment, collection of peri-abutment exudate using paper-points, and a small peri-abutment soft-tissue biopsy) were evaluated for the identification and quantification of colonising bacteria. Twelve patients, seven with machined abutment and five with polished abutment, were included in the analysis. Three different sampling procedures were employed for the identification and quantification of colonising bacteria from baseline up to 12 months, using quantitative culturing. Clinical outcome measures (Holgers score, hygiene, pain, numbness and implant stability) were investigated. The clinical parameters, and total viable bacteria per abutment or in tissue biopsies did not differ significantly between the polished and machined abutments. The total CFU/mm 2 abutment and CFU/peri-abutment fluid space of anaerobes, aerobes and staphylococci were significantly higher for the polished abutment. Anaerobic bacteria were detected in the tissue biopsies before BAHS implantation. Anaerobes and Staphylococcus spp. were detected in all three compartments after BAHS installation. For most patients (10/12), the same staphylococcal species were found in at least two of the three compartments at the same time-point. The common skin coloniser Staphylococcus epidermidis was identified in all patients but one (11/12), whereas the pathogen Staphylococcus aureus was isolated in five of the patients. Several associations between clinical and microbiological parameters were found. There was no difference in the clinical outcome with the use of polished versus machined abutment at 3 and 12 months after implantation. The present pilot trial largely confirmed a suitable study design, sampling and analytical methodology to determine the effects of modified BAHS abutment properties. 2. Controlled prospective comparative study.

The Reliability, Validity, and Evaluation of the Objective Structured Clinical Examination in Podiatry (Chiropody).

ERIC Educational Resources Information Center

Woodburn, Jim; Sutcliffe, Nick

1996-01-01

The Objective Structured Clinical Examination (OSCE), initially developed for undergraduate medical education, has been adapted for assessment of clinical skills in podiatry students. A 12-month pilot study found the test had relatively low levels of reliability, high construct and criterion validity, and good stability of performance over time.…

Randomized pilot study and qualitative evaluation of a clinical decision support system for brain tumour diagnosis based on SV ¹H MRS: evaluation as an additional information procedure for novice radiologists.

PubMed

Sáez, Carlos; Martí-Bonmatí, Luis; Alberich-Bayarri, Angel; Robles, Montserrat; García-Gómez, Juan M

2014-02-01

The results of a randomized pilot study and qualitative evaluation of the clinical decision support system Curiam BT are reported. We evaluated the system's feasibility and potential value as a radiological information procedure complementary to magnetic resonance (MR) imaging to assist novice radiologists in diagnosing brain tumours using MR spectroscopy (1.5 and 3.0T). Fifty-five cases were analysed at three hospitals according to four non-exclusive diagnostic questions. Our results show that Curiam BT improved the diagnostic accuracy in all the four questions. Additionally, we discuss the findings of the users' feedback about the system, and the further work to optimize it for real environments and to conduct a large clinical trial. © 2013 Published by Elsevier Ltd.

CHAracteristics of research studies that iNfluence practice: a GEneral survey of Canadian orthopaedic Surgeons (CHANGES): a pilot survey.

PubMed

de Sa, Darren; Thornley, Patrick; Evaniew, Nathan; Madden, Kim; Bhandari, Mohit; Ghert, Michelle

2015-01-01

Evidence Based Medicine (EBM) is increasingly being applied to inform clinical decision-making in orthopaedic surgery. Despite the promotion of EBM in Orthopaedic Surgery, the adoption of results from high quality clinical research seems highly unpredictable and does not appear to be driven strictly by randomized trial data. The objective of this study was to pilot a survey to determine if we could identify surgeon opinions on the characteristics of research studies that are perceived as being most likely to influence clinical decision-making among orthopaedic surgeons in Canada. A 28-question electronic survey was distributed to active members of the Canadian Orthopaedic Association (COA) over a period of 11 weeks. The questionnaire sought to analyze the influence of both extrinsic and intrinsic characteristics of research studies and their potential to influence practice patterns. Extrinsic factors included the perceived journal quality and investigator profiles, economic impact, peer/patient/industry influence and individual surgeon residency/fellowship training experiences. Intrinsic factors included study design, sample size, and outcomes reported. Descriptive statistics are provided. Of the 109 members of the COA who opened the survey, 95 (87%) completed the survey in its entirety. The overall response rate was 11% (95/841). Surgeons achieved consensus on the influence of three key designs on their practices: 1) randomized controlled trials 94 (99%), 2) meta-analysis 83 (87%), and 3) systematic reviews 81 (85%). Sixty-seven percent of surgeons agreed that studies with sample sizes of 101-500 or more were more likely to influence clinical practice than smaller studies (n = <100). Factors other than design influencing adoption included 1) reputation of the investigators (99%) and 2) perceived quality of the journal (75%). Although study design and sample size (i.e. minimum of 100 patients) have some influence on clinical decision making, surgeon respondents are equally influenced by investigator reputation and perceived journal quality. At present, continued emphasis on the generation of large, methodologically sound clinical trials remains paramount to translating research findings to clinical practice changes. Specific to this pilot survey, strategies to solicit more widespread responses will be pursued.

Piloting Augmented Reality Technology to Enhance Realism in Clinical Simulation.

PubMed

Vaughn, Jacqueline; Lister, Michael; Shaw, Ryan J

2016-09-01

We describe a pilot study that incorporated an innovative hybrid simulation designed to increase the perception of realism in a high-fidelity simulation. Prelicensure students (N = 12) cared for a manikin in a simulation lab scenario wearing Google Glass, a wearable head device that projected video into the students' field of vision. Students reported that the simulation gave them confidence that they were developing skills and knowledge to perform necessary tasks in a clinical setting and that they met the learning objectives of the simulation. The video combined visual images and cues seen in a real patient and created a sense of realism the manikin alone could not provide.

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

A pilot study of clinical agreement in cardiovascular preparticipation examinations: how good is the standard of care?

PubMed

O'Connor, Francis G; Johnson, Jeremy D; Chapin, Mark; Oriscello, Ralph G; Taylor, Dean C

2005-05-01

To evaluate the interobserver agreement between physicians regarding a abnormal cardiovascular assessment on athletic preparticipation examinations. Cross-sectional clinical survey. Outpatient Clinic, United States Military Academy, West Point, NY. We randomly selected 101 out of 539 cadet-athletes presenting for a preparticipation examination. Two primary care sports medicine fellows and a cardiologist examined the cadets. After obtaining informed consent from all participants, all 3 physicians separately evaluated all 101 cadets. The physicians recorded their clinical findings and whether they thought further cardiovascular evaluation (echocardiography) was indicated. Rate of referral for further cardiovascular evaluation, clinical agreement between sports medicine fellows, and clinical agreement between sports medicine fellows and the cardiologist. Each fellow referred 6 of the 101 evaluated cadets (5.9%). The cardiologist referred none. Although each fellow referred 6 cadets, only 1 cadet was referred by both. The kappa statistic for clinical agreement between fellows is 0.114 (95% CI, -0.182 to 0.411). There was no clinical agreement between the fellows and the cardiologist. This pilot study reveals a low level of agreement between physicians regarding which athletes with an abnormal examination deserved further testing. It challenges the standard of care and questions whether there is a need for improved technologies or improved training in cardiovascular clinical assessment.

The Coping Cat Program for Children with Anxiety and Autism Spectrum Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

McNally Keehn, Rebecca H.; Lincoln, Alan J.; Brown, Milton Z.; Chavira, Denise A.

2013-01-01

The purpose of this pilot study was to evaluate whether a modified version of the Coping Cat program could be effective in reducing anxiety in children with autism spectrum disorder (ASD). Twenty-two children (ages 8-14; IQ greater than or equal to 70) with ASD and clinically significant anxiety were randomly assigned to 16 sessions of the Coping…

Critical care staff rotation: outcomes of a survey and pilot study.

PubMed

Richardson, Annette; Douglas, Margaret; Shuttler, Rachel; Hagland, Martin R

2003-01-01

Staff rotation is defined as a reciprocal exchange of staff between two or more clinical areas for a predetermined period of time. The rationale for introducing a 'Critical Care Nurse Rotation Programme' includes important issues such as improving nurses' knowledge and skills, providing development opportunities, networking, the ability to recruit and retain nurses and the provision of a more versatile and flexible workforce. To gain the understanding of nurses' views and opinions on critical care rotation programmes, evidence was collected by means of questionnaires involving 153 critical care nurses and by undertaking semi-structured interviews with four nurses. On the basis of the responses, a pilot of three Critical Care Nurse Rotation Programmes was introduced. An evaluation of the pilot project assessed participants, supervisors and senior nurses' experience of rotation and revealed very positive experiences being reported. The benefits highlighted included improving clinical skills and experience, improving interdepartmental relationships, heightened motivation and opportunities to network. The disadvantages focused on the operational and managerial issues, such as difficulties maintaining supervision and providing an adequate supernumerary period. Evidence from the survey and pilot study suggests that in the future, providing rotational programmes for critical care nurses would be a valuable strategy for recruitment, retention and developing the workforce.

A Pilot Study to Determine the Effect of an Educational DVD in Philippine Languages on Cancer Clinical Trial Participation among Filipinos in Hawai'i.

PubMed

Felicitas-Perkins, Jamie Q; Palalay, Melvin Paul; Cuaresma, Charlene; Ho, Reginald Cs; Chen, Moon S; Dang, Julie; Loui, William S

2017-07-01

We conducted an experimental pilot study in an oncology clinic in Honolulu, Hawai'i to determine the effect of a culturally-tailored educational DVD on cancer clinical trial participation among Filipino cancer patients. Thirty-seven patients participated in the study, with 17 randomized into the control group (ie, usual education) and 20 into the intervention group (ie, usual education plus educational DVD). Participants completed pre- and post-educational questionnaires with items asking about understanding of several cancer topics, behavioral outcomes, and attitudes regarding several treatment and physician related topics. A Fisher's exact test was conducted to explore the association between enrollment into a clinical trial and group assignment. General linear models were created to determine significant differences between study groups in post-education response scores for each questionnaire item after controlling for age, gender, education, and pre-education response scores. Two participants from the control group and three participants from the intervention group enrolled into clinical trials. Results showed no significant association between clinical trial enrollment and study group assignment ( P > .99). A significant difference was found between study groups on surety of joining the clinical trial suggested to them ( P = .013). A multilingual educational DVD to supplement clinical trial education may positively influence Filipino cancer patients to move forward with the decision to join a cancer clinical trial. However, health literacy may serve as a major barrier to actual enrollment into the particular clinical trial available to a patient.

A CIS (Clinical Information System) Quality Evaluation Tool for Nursing Care Services

ERIC Educational Resources Information Center

Lee, Seon Ah

2010-01-01

The purpose of this study was to develop a tool to evaluate the quality of a clinical information system (CIS) conceived by nurses and conduct a pilot test with the developed tool as an initial assessment. CIS quality is required for successful implementation in information technology (IT) environments. The study started with the realization that…

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.

Using video feedback to improve early father-infant interaction: a pilot study.

PubMed

Lawrence, Peter J; Davies, Beverley; Ramchandani, Paul G

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child's thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers' feedback was generally positive. The flexibility to conduct sessions at home (or at fathers' places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers.

Legacy system integration using web technology

NASA Astrophysics Data System (ADS)

Kennedy, Richard L.; Seibert, James A.; Hughes, Chris J.

2000-05-01

As healthcare moves towards a completely digital, multimedia environment there is an opportunity to provide for cost- effective, highly distributed physician access to clinical information including radiology-based imaging. In order to address this opportunity a Universal Clinical Desktop (UCD) system was developed. A UCD provides a single point of entry into an integrated view of all types of clinical data available within a network of disparate healthcare information systems. In order to explore the application of a UCD in a hospital environment, a pilot study was established with the University of California Davis Medical Center using technology from Trilix Information Systems. Within this pilot environment the information systems integrated under the UCD include a radiology information system (RIS), a picture archive and communication system (PACS) and a laboratory information system (LIS).

First-in-human pilot study of a spatial frequency domain oxygenation imaging system

NASA Astrophysics Data System (ADS)

Gioux, Sylvain; Mazhar, Amaan; Lee, Bernard T.; Lin, Samuel J.; Tobias, Adam M.; Cuccia, David J.; Stockdale, Alan; Oketokoun, Rafiou; Ashitate, Yoshitomo; Kelly, Edward; Weinmann, Maxwell; Durr, Nicholas J.; Moffitt, Lorissa A.; Durkin, Anthony J.; Tromberg, Bruce J.; Frangioni, John V.

2011-08-01

Oxygenation measurements are widely used in patient care. However, most clinically available instruments currently consist of contact probes that only provide global monitoring of the patient (e.g., pulse oximetry probes) or local monitoring of small areas (e.g., spectroscopy-based probes). Visualization of oxygenation over large areas of tissue, without a priori knowledge of the location of defects, has the potential to improve patient management in many surgical and critical care applications. In this study, we present a clinically compatible multispectral spatial frequency domain imaging (SFDI) system optimized for surgical oxygenation imaging. This system was used to image tissue oxygenation over a large area (16×12 cm) and was validated during preclinical studies by comparing results obtained with an FDA-approved clinical oxygenation probe. Skin flap, bowel, and liver vascular occlusion experiments were performed on Yorkshire pigs and demonstrated that over the course of the experiment, relative changes in oxygen saturation measured using SFDI had an accuracy within 10% of those made using the FDA-approved device. Finally, the new SFDI system was translated to the clinic in a first-in-human pilot study that imaged skin flap oxygenation during reconstructive breast surgery. Overall, this study lays the foundation for clinical translation of endogenous contrast imaging using SFDI.

First-in-human pilot study of a spatial frequency domain oxygenation imaging system

PubMed Central

Gioux, Sylvain; Mazhar, Amaan; Lee, Bernard T.; Lin, Samuel J.; Tobias, Adam M.; Cuccia, David J.; Stockdale, Alan; Oketokoun, Rafiou; Ashitate, Yoshitomo; Kelly, Edward; Weinmann, Maxwell; Durr, Nicholas J.; Moffitt, Lorissa A.; Durkin, Anthony J.; Tromberg, Bruce J.; Frangioni, John V.

2011-01-01

Oxygenation measurements are widely used in patient care. However, most clinically available instruments currently consist of contact probes that only provide global monitoring of the patient (e.g., pulse oximetry probes) or local monitoring of small areas (e.g., spectroscopy-based probes). Visualization of oxygenation over large areas of tissue, without a priori knowledge of the location of defects, has the potential to improve patient management in many surgical and critical care applications. In this study, we present a clinically compatible multispectral spatial frequency domain imaging (SFDI) system optimized for surgical oxygenation imaging. This system was used to image tissue oxygenation over a large area (16×12 cm) and was validated during preclinical studies by comparing results obtained with an FDA-approved clinical oxygenation probe. Skin flap, bowel, and liver vascular occlusion experiments were performed on Yorkshire pigs and demonstrated that over the course of the experiment, relative changes in oxygen saturation measured using SFDI had an accuracy within 10% of those made using the FDA-approved device. Finally, the new SFDI system was translated to the clinic in a first-in-human pilot study that imaged skin flap oxygenation during reconstructive breast surgery. Overall, this study lays the foundation for clinical translation of endogenous contrast imaging using SFDI. PMID:21895327

Cross-sectional study of neck pain and cervical sagittal alignment in air force pilots.

PubMed

Moon, Bong Ju; Choi, Kyong Ho; Yun, Chul; Ha, Yoon

2015-05-01

There is a high prevalence of neck pain in air force pilots; however, the causes are not clear and are considered work-related. Kyphotic changes in the cervical spine have been known to cause neck pain. In this study, we investigated the association between neck pain and cervical kyphosis in air force pilots. This is a cross-sectional study of 63 Republic of South Korea Air Force pilots. We examined the C2-7 absolute rotation angle (ARA) using the posterior tangent method and other radiologic parameters on whole spine lateral radiographs. We divided the participants into a neck pain group (N = 32) and no neck pain group (N = 31), and subsequently analyzed the difference in radiographic parameters and clinical data between the two groups. There were no significant differences found in age, body mass index, total flight time, or aerobic or anaerobic exercise between the neck pain and control groups. The fighter pilots had higher 1-yr prevalence of neck pain than nonfighter pilots (84.4% vs. 15.6%). The lower C2-7 ARA (OR = 0.91, 95% CI 0.846, 0.979) and fighter type aircrafts (OR = 3.93, 95% CI 1.104, 13.989) were associated with neck pain. Fighter pilots experienced neck pain more frequently than the nonfighter pilots. Those fighter pilots suffering from neck pain were shown to have more kyphotic changes in the cervical spine than control pilots through evaluation of whole spine lateral radiographs using the posterior tangent method. These key findings suggest that the forces involved in flying a fighter type aircraft may affect cervical alignment and neck pain.

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 ).

The Implementation and Development of an Objective Structured Clinical Examination in the Community Pharmacy Course of a Select Gulf-Region Academic Institution (Ras Al Khaimah College of Pharmaceutical Sciences): A Pilot Study

ERIC Educational Resources Information Center

Al-Azzawi, Amad Mohammed Jamil; Nagavi, B.G.; Hachim, Mahmood Y.; Mossa, Omar H.

2016-01-01

Background: Objective Structured Clinical Examinations (OSCEs) were used to assess translational pharmacotherapeutic skills of a Gulf-region representative academic institution. Aim: The aim of the current study was to assess the clinical skills of students enrolled within the third year Bachelor of Pharmacy (BPharm) programme within Ras Al…

Difficulties encountered at the beginning of professional life: results of a 2003 pilot survey among undergraduate students in Paris Rene Descartes University (France).

PubMed

Benbelaïd, R; Dot, D; Levy, G; Eid, N

2006-11-01

In addition to dental hospital clinical activity, dental students at Paris Rene Descartes University have the opportunity in their final year of study to practise clinically in a dental office, as associates. This paper outlines a pilot, experimental study designed to assess student reaction to this Vocational Clinical Activity (VCA) in order to identify relevant weaknesses of the undergraduate programme. Using questionnaires, data were collected for each of the following clinical or management skills: clinical difficulty, therapeutic decision-making, patient/practitioner relationship, time management, administrative matters and technical problems. Students were asked to rank each item in order of difficulty (1, high level to 6, low level). A high response rate was observed (90%) among the 50 undergraduate VCA students. The results pointed out three main difficulties encountered by undergraduate students during the VCA: time management (90% of the students), administrative matters (85% of the students) and clinical decision-making (80% of the students). These preliminary results need further investigation. However, they give us the incentive to carry on with this type of assessment and to extend it to young, qualified colleagues' perceptions and to other French Universities.

Exploring the validity and reliability of a questionnaire for evaluating veterinary clinical teachers' supervisory skills during clinical rotations.

PubMed

Boerboom, T B B; Dolmans, D H J M; Jaarsma, A D C; Muijtjens, A M M; Van Beukelen, P; Scherpbier, A J J A

2011-01-01

Feedback to aid teachers in improving their teaching requires validated evaluation instruments. When implementing an evaluation instrument in a different context, it is important to collect validity evidence from multiple sources. We examined the validity and reliability of the Maastricht Clinical Teaching Questionnaire (MCTQ) as an instrument to evaluate individual clinical teachers during short clinical rotations in veterinary education. We examined four sources of validity evidence: (1) Content was examined based on theory of effective learning. (2) Response process was explored in a pilot study. (3) Internal structure was assessed by confirmatory factor analysis using 1086 student evaluations and reliability was examined utilizing generalizability analysis. (4) Relations with other relevant variables were examined by comparing factor scores with other outcomes. Content validity was supported by theory underlying the cognitive apprenticeship model on which the instrument is based. The pilot study resulted in an additional question about supervision time. A five-factor model showed a good fit with the data. Acceptable reliability was achievable with 10-12 questionnaires per teacher. Correlations between the factors and overall teacher judgement were strong. The MCTQ appears to be a valid and reliable instrument to evaluate clinical teachers' performance during short rotations.

Development and clinical introduction of automated radiotherapy treatment planning for prostate cancer

NASA Astrophysics Data System (ADS)

Winkel, D.; Bol, G. H.; van Asselen, B.; Hes, J.; Scholten, V.; Kerkmeijer, L. G. W.; Raaymakers, B. W.

2016-12-01

To develop an automated radiotherapy treatment planning and optimization workflow to efficiently create patient specifically optimized clinical grade treatment plans for prostate cancer and to implement it in clinical practice. A two-phased planning and optimization workflow was developed to automatically generate 77Gy 5-field simultaneously integrated boost intensity modulated radiation therapy (SIB-IMRT) plans for prostate cancer treatment. A retrospective planning study (n  =  100) was performed in which automatically and manually generated treatment plans were compared. A clinical pilot (n  =  21) was performed to investigate the usability of our method. Operator time for the planning process was reduced to  <5 min. The retrospective planning study showed that 98 plans met all clinical constraints. Significant improvements were made in the volume receiving 72Gy (V72Gy) for the bladder and rectum and the mean dose of the bladder and the body. A reduced plan variance was observed. During the clinical pilot 20 automatically generated plans met all constraints and 17 plans were selected for treatment. The automated radiotherapy treatment planning and optimization workflow is capable of efficiently generating patient specifically optimized and improved clinical grade plans. It has now been adopted as the current standard workflow in our clinic to generate treatment plans for prostate cancer.

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study

PubMed Central

Juhász, Márk; Nagy, Viktor L.; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F.

2014-01-01

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m−1 gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. PMID:25008086

Influence of inhomogeneous static magnetic field-exposure on patients with erosive gastritis: a randomized, self- and placebo-controlled, double-blind, single centre, pilot study.

PubMed

Juhász, Márk; Nagy, Viktor L; Székely, Hajnal; Kocsis, Dorottya; Tulassay, Zsolt; László, János F

2014-09-06

This pilot study was devoted to the effect of static magnetic field (SMF)-exposure on erosive gastritis. The randomized, self- and placebo-controlled, double-blind, pilot study included 16 patients of the 2nd Department of Internal Medicine, Semmelweis University diagnosed with erosive gastritis. The instrumental analysis followed a qualitative (pre-intervention) assessment of the symptoms by the patient: lower heartburn (in the ventricle), upper heartburn (in the oesophagus), epigastric pain, regurgitation, bloating and dry cough. Medical diagnosis included a double-line upper panendoscopy followed by 30 min local inhomogeneous SMF-exposure intervention at the lower sternal region over the stomach with peak-to-peak magnetic induction of 3 mT and 30 mT m(-1) gradient at the target site. A qualitative (post-intervention) assessment of the same symptoms closed the examination. Sham- or SMF-exposure was used in a double-blind manner. The authors succeeded in justifying the clinically and statistically significant beneficial effect of the SMF- over sham-exposure on the symptoms of erosive gastritis, the average effect of inhibition was 56% by p = 0.001, n = 42 + 96. This pilot study was aimed to encourage gastroenterologists to test local, inhomogeneous SMF-exposure on erosive gastritis patients, so this intervention may become an evidence-based alternative or complementary method in the clinical use especially in cases when conventional therapy options are contraindicated. © 2014 The Author(s) Published by the Royal Society. All rights reserved.

The potential of telehealth for 'business as usual' in outpatient clinics.

PubMed

Day, Karen; Kerr, Patricia

2012-04-01

A six-month pilot study was conducted to ascertain the value of using high-definition videoconferencing equipment in an outpatients' setting. The videoconferencing equipment, which included digital biometric equipment, was installed in the outpatient clinics of a remote health service in New Zealand. Use of the equipment was evaluated using action research techniques. Clinicians were interviewed about their assessment of the equipment's usefulness. Patients and their carers completed questionnaires about their clinic experience. During the pilot trial, 109 patients were seen in 25 clinics of six different specialities. Questionnaire results showed that patients and their companions had a good user experience, similar to a face-to-face appointment. Clinicians found that the large screen, sense of proximity, video clarity and definition, and lack of sound/picture lag worked well for certain types of outpatients' clinics, e.g. methadone maintenance clinics. The need for process changes made it difficult to turn telehealth into business as usual in an environment built for face-to-face appointments. We conclude that videoconference equipment has potential to become integral to outpatients' clinics.

A rapid assessment of a community health worker pilot programme to improve the management of hypertension and diabetes in Emfuleni sub-district of Gauteng Province, South Africa.

PubMed

Ndou, Tshipfuralo; van Zyl, Greer; Hlahane, Salamina; Goudge, Jane

2013-01-24

Non-communicable diseases (NCD) and infectious chronic illnesses are recognised as significant contributing factors to the burden of disease globally, specifically in South Africa, yet clinical management is often poor. The involvement of community health workers (CHWs) in TB and HIV care in South Africa, and other low- and middle-income settings, suggests that they could make an important contribution in the management of NCDs. Using a rapid assessment, this study examines the outcomes of a pilot CHW programme to improve the management of hypertension and diabetes in Gauteng province, South Africa. A record review compared outcomes of patients receiving home visits (n56) with a control group (n168) attending the clinic, matched, as far as possible, on age, gender, and condition. Focus group discussions and semi-structured interviews with CHWs, patients, district, clinic, and NGO staff were used to obtain descriptions of the functioning of the programme and patient experiences. Despite the greater age and co-morbidity among those in the pilot programme, the findings suggest that control of hypertension was improved by CHW home visits in comparison to usual clinic care. However, too few doctor visits, insufficient monitoring of patient outcomes by clinic staff, and a poor procurement process for supplies required by the CHWs hampered the programme's activities. The role of CHWs in the management of hypertension should be given greater consideration, with larger studies being conducted to provide more robust evidence. Adequate training, supervision, and operational support will be required to ensure success of any CHW programme.

Long-term effects of exercise programs among helicopter pilots with flying related LBP

PubMed Central

Andersen, Knut; Baardsen, Roald; Dalen, Ingvild; Larsen, Jan Petter

2017-01-01

BACKGROUND: Flying related transient Low Back Pain (LBP) among helicopter pilots is considered an occupational distress. OBJECTIVE: To examine if exercise programs can alleviate transient LBP. METHODS: Sixty-five helicopter pilots (92% males), all reporting flying related LBP, responded to an epidemiological survey and a long-term follow-up, 44.8 months later, comprising questions regarding transient LBP and number of sick leaves. Data from 37 pilots participating in two exercise programs, A; general for LBP, B; focused for lumbar trunk (LT), included information from clinical examinations and muscular endurance tests of the LT before and after intervention. Twenty-eight pilots did not participate in any intervention. RESULTS: At long-term follow-up 42% of the pilots still reported flying related transient LBP. Among participants in program B 26% had persistent pain, 70% in program A and 46% among pilots without intervention. Sick-leave reduction was only observed among participants in program B (30% to 4%). Upon re-occurrence of LBP symptoms, half of the pilots in program B again performed exercises to improve their pain. CONCLUSION: This study indicates that exercise programs focused towards lumbar trunk muscular endurance reduces flying related transient LBP and sick-leave among helicopter pilots. These findings may have implications for the pilots’ working conditions. PMID:29278872

Can enriching emotional intelligence improve medical students' proactivity and adaptability during OB/GYN clerkships?

PubMed

Guseh, Stephanie H; Chen, Xiaodong P; Johnson, Natasha R

2015-12-26

The purpose of this pilot study was to examine our hypothesis that enriching workplace emotional intelligence through resident coaches could improve third-year medical students' adaptability and proactivity on the Obstetrics and Gynecology clerkship. An observational pilot study was conducted in a teaching hospital. Fourteen 3rd year medical students from two cohorts of clerkships were randomly divided into two groups, and equally assigned to trained resident coaches and untrained resident coaches. Data was collected through onsite naturalistic observation of students' adaptability and proactivity in clinical settings using a checklist with a 4-point Likert scale (1=poor to 4=excellent). Wilcoxon rank-sum test was used to compare the differences between these two groups. A total of 280 data points were collected through onsite observations conducted by investigators. All (n=14) students' adaptability and proactivity performance significantly improved from an average of 3.04 to 3.45 (p=0.014) over 6-week clerkship. Overall, students with trained resident coaches adapted significantly faster and were more proactive in the obstetrics and gynecology clinical setting than the students with untrained coaches (3.31 vs. 3.24, p=0.019). Findings from our pilot study supported our hypothesis that enriching workplace emotional intelligence knowledge through resident coaches was able to help medical students adapt into obstetrics and gynecology clinical settings faster and become more proactive in learning. Clerkship programs can incorporate the concept of a resident coach in their curriculum to help bridge medical students into clinical settings and to help them engage in self-directed learning throughout the rotation.

'Act on oncology' as a new comprehensive approach to assess prostate cancer centres--method description and results of a pilot study.

PubMed

Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

2014-01-01

Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. 'Act On Oncology'(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency.

Can enriching emotional intelligence improve medical students’ proactivity and adaptability during OB/GYN clerkships?

PubMed Central

Guseh, Stephanie H.; Chen, Xiaodong P.

2015-01-01

Objectives The purpose of this pilot study was to examine our hypothesis that enriching workplace emotional intelligence through resident coaches could improve third-year medical students’ adaptability and proactivity on the Obstetrics and Gynecology clerkship. Methods An observational pilot study was conducted in a teaching hospital. Fourteen 3rd year medical students from two cohorts of clerkships were randomly divided into two groups, and equally assigned to trained resident coaches and untrained resident coaches. Data was collected through onsite naturalistic observation of students’ adaptability and proactivity in clinical settings using a checklist with a 4-point Likert scale (1=poor to 4=excellent). Wilcoxon rank-sum test was used to compare the differences between these two groups. Results A total of 280 data points were collected through onsite observations conducted by investigators. All (n=14) students’ adaptability and proactivity performance significantly improved from an average of 3.04 to 3.45 (p=0.014) over 6-week clerkship. Overall, students with trained resident coaches adapted significantly faster and were more proactive in the obstetrics and gynecology clinical setting than the students with untrained coaches (3.31 vs. 3.24, p=0.019). Conclusions Findings from our pilot study supported our hypothesis that enriching workplace emotional intelligence knowledge through resident coaches was able to help medical students adapt into obstetrics and gynecology clinical settings faster and become more proactive in learning. Clerkship programs can incorporate the concept of a resident coach in their curriculum to help bridge medical students into clinical settings and to help them engage in self-directed learning throughout the rotation. PMID:26708233

A pilot study to assess the pharmacy impact of implementing a chemotherapy-induced nausea or vomiting collaborative disease therapy management in the outpatient oncology clinics.

PubMed

Jackson, Kasey; Letton, Cathy; Maldonado, Andy; Bodiford, Andrew; Sion, Amy; Hartwell, Rebekah; Graham, Anastasia; Bondarenka, Carolyn; Uber, Lynn

2018-01-01

Background Collaborative drug therapy management is a formal partnership between a pharmacist and physician to allow the pharmacist to manage a patient's drug therapy. Literature supports collaborative disease therapy management can improve patient outcomes, improve medication adherence, enhance medication safety, and positively influence healthcare expenditures. Chemotherapy induced nausea or vomiting is considered one of the most distressing and feared adverse events among patients receiving chemotherapy. Chemotherapy induced nausea or vomiting can impact a patient's quality of life and may affect compliance with the treatment plan. Purpose The objective of this pilot study was to determine the pharmacy impact of implementing a chemotherapy induced nausea or vomiting collaborative disease therapy management protocol in the outpatient oncology clinics at a National Cancer Institute (NCI)-designated cancer center associated with an academic medical center. The primary endpoint was to determine the number and type of chemotherapy induced nausea or vomiting clinical interventions made by the oncology pharmacists. Secondary endpoints included comparing patient's Multinational Association for Supportive Care in Cancer scores and revenue of pharmacists' services. Methods The credentialed oncology pharmacists were consulted by an oncologist to manage chemotherapy induced nausea or vomiting. Patients were included in the chemotherapy induced nausea or vomiting collaborative disease therapy management if they were seen in an outpatient oncology clinic from October 2016 to January 2017 and had a referral from a qualified provider to help manage chemotherapy induced nausea or vomiting. Patients admitted to the hospital at the time of consult were excluded from the study. The pharmacists interviewed patients and provided recommendations. The pharmacists followed up with the patient via a telephone call or during the next scheduled clinic visit to assess their symptoms. Results The chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study was implemented in October 2016. From October 2016 to January 2017, there were 45 consults for the management of chemotherapy induced nausea or vomiting. The pharmacists made 188 clinical interventions, which included addition of new medications (37%), patient education (34%), deletion of medications (10%), changing a dose/duration/frequency (8%), and other interventions (11%). Multinational Association for Supportive Care in Cancer symptom scores were available for 5 patients, in which all showed improvements from baseline with the pharmacists' clinical interventions. Conclusions The implementation of our chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study has shown favorable results after a 4-month evaluation period. The pharmacists have made a substantial number of clinical interventions and provided patient education to patients undergoing chemotherapy.

Telephone-administered cognitive-behavioral therapy for clients with depressive symptoms in an employee assistance program: a pilot study.

PubMed

Lam, Raymond W; Lutz, Kevin; Preece, Melady; Cayley, Paula M; Bowen Walker, Anne

2011-02-01

To assess the clinical and work productivity effects of a brief intervention using telephone-administered cognitive-behavioral therapy (CBT) for clients with depressive symptoms attending an employee assistance program (EAP). Self-referred clients attending the PPC Canada EAP with clinically relevant depressive symptoms at initial assessment were offered an 8-session telephone-administered CBT program. Outcomes before and after intervention were assessed with the 9-item Personal Health Questionnaire (PHQ-9), Global Assessment of Functioning (GAF), and clinician ratings of work absence and performance impairment. Fifty clients were referred to the pilot program; 39 participated and 31 completed the telephone CBT program. Among program participants, there was significant improvement in PHQ-9 and GAF scores. There was also a significant reduction in performance impairment but not work absence. Anecdotal reports indicated high satisfaction ratings among participants. The results of this pilot study, although limited by the absence of a comparison or control group, suggest that a brief telephone-administered CBT program can improve depressive symptomatology, work productivity, and general function in depressed clients attending an EAP. Further controlled studies are needed to confirm these preliminary findings.

Scan-layered reconstructions: A pilot study of a nondestructive dental histoanatomical analysis method and digital workflow to create restorations driven by natural dentin and enamel morphology.

PubMed

Malta Barbosa, João; Tovar, Nick; A Tuesta, Pablo; Hirata, Ronaldo; Guimarães, Nuno; Romanini, José C; Moghadam, Marjan; Coelho, Paulo G; Jahangiri, Leila

2017-07-08

This work aims to present a pilot study of a non-destructive dental histo-anatomical analysis technique as well as to push the boundaries of the presently available restorative workflows for the fabrication of highly customized ceramic restorations. An extracted human maxillary central incisor was subject to a micro computed tomography scan and the acquired data was transferred into a workstation, reconstructed, segmented, evaluated and later imported into a Computer-Aided Design/Computer-Aided Manufacturing software for the fabrication of a ceramic resin-bonded prosthesis. The obtained prosthesis presented an encouraging optical behavior and was used clinically as final restoration. The digitally layered restorative replication of natural tooth morphology presents today as a clear possibility. New clinical and laboratory-fabricated, biologically inspired digital restorative protocols are to be expected in the near future. The digitally layered restorative replication of natural tooth morphology presents today as a clear possibility. This pilot study may represent a stimulus for future research and applications of digital imaging as well as digital restorative workflows in service of esthetic dentistry. © 2017 Wiley Periodicals, Inc.

First clinical pilot study with intravascular polarization sensitive optical coherence tomography (Conference Presentation)

NASA Astrophysics Data System (ADS)

Villiger, Martin; Karanasos, Antonios; Ren, Jian; Lippok, Norman; Shishkov, Milen; Daemen, Joost; Van Mieghem, Nicolas; Diletti, Roberto; Valgimigli, Marco; van Geuns, Robert-Jan; de Jaegere, Peter; Zijlstra, Felix; van Soest, Gijs; Nadkarni, Seemantini; Regar, Evelyn; Bouma, Brett E.

2016-02-01

Polarization sensitive (PS) OCT measures the polarization states of the light backscattered by tissue and provides measures of tissue birefringence and depolarization in addition to the structural OCT signal. Ex vivo studies have demonstrated that birefringence is increased in tissue rich in collagen and with elevated smooth muscle cell content. Preliminary data further suggests that depolarization can identify regions of macrophage infiltration, lipid, and irregularly arranged collagen fibers. These are important aspects of the mechanical integrity and vulnerability of atherosclerotic plaques. To evaluate the potential of PS-OCT in the clinical setting, we combined our custom PS-OCT system with commercially available OCT catheters (Fastview, Terumo Corporation) and performed a pilot study in 30 patients, scheduled to undergo percutaneous coronary intervention (PCI) on the grounds of stable or unstable angina. A total of 82 pullbacks in 39 vessels were performed, either in the native coronary arteries or post procedure. Comparing consecutive pullbacks of the same coronary artery, we found excellent agreement between the polarization features in the repeat pullbacks, validating the repeatability and robustness of PS-OCT in the clinical in vivo setting. In addition we observed that the birefringence and depolarization features vary significantly across lesions with identical structural OCT appearance, suggesting morphological subtypes. This first human pilot study proved the feasibility and robustness of intravascular PS-OCT. PS-OCT achieves improved tissue characterization and may help in identifying high-risk plaques, with the potential to ultimately improve risk stratification and help guiding PCI.

Neuromuscular orthotics in the treatment of craniomandibular dysfunction and the effects on patients with multiple sclerosis: a pilot study.

PubMed

Heit, Tammarie

2011-01-01

The purpose of this pilot study was to identify, measure and document an effect on the subjective multiple sclerosis symptoms and compare it to any objective data changes in the neuromuscular system of the head and neck, following the correction of the jaw position using a neuromuscular orthotic. The hope is to provide clinical evidence of improvement in the disease long-term without relying on the subjective evidence of remissions and exacerbations reported by the patient. The evidence found in the current pilot study measured improvement of head position, jaw position, jaw function, and airway in the neuromuscular bite position, which correlated with the improvement of subjective symptoms of craniomandibular dysfunction and multiple sclerosis. Studies show that the bite affects blood flow in the brain, which may explain the improvement of the patients in the current study.

Successful Completion of the Pilot Phase of a Randomized Controlled Trial Comparing Sentinel Lymph Node Biopsy to No Further Axillary Staging in Patients with Clinical T1-T2 N0 Breast Cancer and Normal Axillary Ultrasound.

PubMed

Cyr, Amy E; Tucker, Natalia; Ademuyiwa, Foluso; Margenthaler, Julie A; Aft, Rebecca L; Eberlein, Timothy J; Appleton, Catherine M; Zoberi, Imran; Thomas, Maria A; Gao, Feng; Gillanders, William E

2016-08-01

Axillary surgery is not considered therapeutic in patients with clinical T1-T2 N0 breast cancer. The importance of axillary staging is eroding in an era in which tumor biology, as defined by biomarker and gene expression profile, is increasingly important in medical decision making. We hypothesized that axillary ultrasound (AUS) is a noninvasive alternative to sentinel lymph node biopsy (SLNB), and AUS could replace SLNB without compromising patient care. Patients with clinical T1-T2 N0 breast cancer and normal AUS were eligible for enrollment. Subjects were randomized to no further axillary staging (arm 1) vs SLNB (arm 2). Descriptive statistics were used to describe the results of the pilot phase of the randomized controlled trial. Sixty-eight subjects were enrolled in the pilot phase of the trial (34 subjects in arm 1, no further staging; 32 subjects in arm 2, SLNB; and 2 subjects voluntarily withdrew from the trial). The median age was 61 years (range 40 to 80 years) in arm 1 and 59 years (range 31 to 81 years) in arm 2, and there were no significant clinical or pathologic differences between the arms. Median follow-up was 17 months (range 1 to 32 months). The negative predictive value (NPV) of AUS for identification of clinically significant axillary disease (>2.0 mm) was 96.9%. No axillary recurrences have been observed in either arm. Successful completion of the pilot phase of the randomized controlled trial confirms the feasibility of the study design, and provides prospective evidence supporting the ability of AUS to exclude clinically significant disease in the axilla. The results provide strong support for a phase 2 randomized controlled trial. Copyright © 2016 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

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

Development and testing of study tools and methods to examine ethnic bias and clinical decision-making among medical students in New Zealand: The Bias and Decision-Making in Medicine (BDMM) study.

PubMed

Harris, Ricci; Cormack, Donna; Curtis, Elana; Jones, Rhys; Stanley, James; Lacey, Cameron

2016-07-11

Health provider racial/ethnic bias and its relationship to clinical decision-making is an emerging area of research focus in understanding and addressing ethnic health inequities. Examining potential racial/ethnic bias among medical students may provide important information to inform medical education and training. This paper describes the development, pretesting and piloting of study content, tools and processes for an online study of racial/ethnic bias (comparing Māori and New Zealand European) and clinical decision-making among final year medical students in New Zealand (NZ). The study was developed, pretested and piloted using a staged process (eight stages within five phases). Phase 1 included three stages: 1) scoping and conceptual framework development; 2) literature review and identification of potential measures and items; and, 3) development and adaptation of study content. Three main components were identified to assess different aspects of racial/ethnic bias: (1) implicit racial/ethnic bias using NZ-specific Implicit Association Tests (IATs); (2) explicit racial/ethnic bias using direct questions; and, (3) clinical decision-making, using chronic disease vignettes. Phase 2 (stage 4) comprised expert review and refinement. Formal pretesting (Phase 3) included construct testing using sorting and rating tasks (stage 5) and cognitive interviewing (stage 6). Phase 4 (stage 7) involved content revision and building of the web-based study, followed by pilot testing in Phase 5 (stage 8). Materials identified for potential inclusion performed well in construct testing among six participants. This assisted in the prioritisation and selection of measures that worked best in the New Zealand context and aligned with constructs of interest. Findings from the cognitive interviewing (nine participants) on the clarity, meaning, and acceptability of measures led to changes in the final wording of items and ordering of questions. Piloting (18 participants) confirmed the overall functionality of the web-based questionnaire, with a few minor revisions made to the final study. Robust processes are required in the development of study content to assess racial/ethnic bias in order to optimise the validity of specific measures, ensure acceptability and minimise potential problems. This paper has utility for other researchers in this area by informing potential development approaches and identifying possible measurement tools.

Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol.

PubMed

Murray, Mike; Lange, Britt; Nørnberg, Bo Riebeling; Søgaard, Karen; Sjøgaard, Gisela

2015-08-19

Flight-related neck/shoulder pain is frequent among military helicopter pilots and crew members. With a lifetime prevalence of 81% for pilots and 84% for crew members, the prevalence of neck pain is considered high compared to the general population. The aim of this study was to investigate whether a specifically tailored exercise intervention would reduce the prevalence and incidence rate of neck/shoulder pain among helicopter pilots and crew members. This study used a prospective, parallel group, single blinded, randomized controlled design. Participants were military helicopter pilots and crew members recruited from the Royal Danish Air Force. Inclusion criteria were: 1) employed within the Royal Danish Air Force as a helicopter pilot or onboard crew member (technician, systems-operator, tactical helicopter observer and/or navigator), 2) maintaining operational flight status at enrollment, and 3) operational flying within the previous 6 months. Primary outcome was change in neck and shoulder pain assessed by 1) a modified version of the "Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms" and by 2) pressure pain threshold measurements. Secondary outcomes included: postural balance, strength, stability, and rate of force development for neck and shoulder muscles. Measurements at baseline and follow-up were conducted at four air force bases in Denmark. Sixty-nine participants were individually randomized to either a training group (TG) or a reference group (RG). Participants in the TG performed 20-weeks of physical exercise training divided into sessions of 3 × 20 min per week. Training was completed within working hours and consisted of specific exercise training for the neck and shoulder muscles based on the principles of "Intelligent Physical Exercise Training". The RG received no training. In spite of the high prevalence of flight related neck/shoulder pain among military helicopter pilots and crew members there are currently no evidence based guidelines for the prevention or clinical handling of neck pain among these occupational groups. Results from this study may therefore be beneficial for future establishment of such guidelines. Ethical committee of Southern Denmark (S-20120121) 29 August, 2012. Clinical Trail Registration (NCT01926262) 16 August, 2013.

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.

Using Patient Reported Outcomes and PROMIS in Research and Clinical Applications: Experiences from the PCORI Pilot Projects

PubMed Central

Bingham, Clifton O.; Bartlett, Susan J.; Merkel, Peter A.; Mielenz, Thelma J.; Pilkonis, Paul A.; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K.

2016-01-01

Purpose The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes, and in particular, the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Methods Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects’ experiences. Results Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. Conclusions The PCORI Pilot Projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders. PMID:26914103

Using patient-reported outcomes and PROMIS in research and clinical applications: experiences from the PCORI pilot projects.

PubMed

Bingham, Clifton O; Bartlett, Susan J; Merkel, Peter A; Mielenz, Thelma J; Pilkonis, Paul A; Edmundson, Lauren; Moore, Emily; Sabharwal, Rajeev K

2016-08-01

The field of patient-centered outcomes research (PCOR) continues to develop. Patient-reported outcomes and, in particular the Patient-Reported Outcomes Measurement Information System (PROMIS) contribute complementary data to clinician-derived outcomes traditionally used in health decision-making. However, there has been little work to understand how PROMIS measures may inform or be integrated into PCOR or clinical applications. Lead investigators from four pilot projects funded by the Patient-Centered Outcomes Research Institute (PCORI) collaborated to discuss lessons learned about the use of PROMIS in PCOR studies via virtual and in-person meetings. In addition, a qualitative data collection tool was used to assess the pilot projects' experiences. Lessons learned from the pilot projects centered on practical elements of research design, such as choosing the right outcomes to study, considering the advantages and limitations of the PROMIS short forms and computer adaptive technology versions, planning ahead for a feasible data collection process, maintaining the focus on patients by ensuring that the research is truly patient-centered, and helping patients and providers make the most of PROMIS in care. The PCORI pilot projects demonstrated that PROMIS can be successfully used to conduct research that will help patients make decisions about their care. Interest in PCOR continues to grow and the lessons learned from these projects about the use of PROMIS will be helpful to investigators. Given the numerous benefits of PROMIS, implementing this tool in research and care will hopefully lead to significant progress in measuring health outcomes that are meaningful and relevant to all stakeholders.

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Conservative Management of Mechanical Neck Pain in a Helicopter Pilot.

PubMed

Alagha, Babak

2015-10-01

Acute and chronic spinal symptoms such as neck pain may limit flying performance significantly and disqualify the pilot from flight duty. Mechanical neck pain is very common among pilots because of their exposure to vibration, +GZ forces, helmet weight, poor neck posture during air combat maneuvers, previous neck injuries, and poor treatment plans for such injuries. Successful treatment of such injuries requires appropriate therapeutic procedures as well as an aeromedical assessment. The aim of this case study was to demonstrate the benefits of conservative procedures such as spinal manipulation and mobilization therapy (SMMT) and exercise therapy (ET) in treating chronic mechanical neck pain in an Iranian commercial helicopter pilot. A 36-yr-old male patient presented to the clinic with moderate, intermittent nonradicular chronic neck pain and limited range of motion over a 2-yr period. The patient was treated with cervical and upper thoracic SMMT followed by home ET for 5 wk. After this period, the patient reported significant recovery and improvement in range of motion in his neck. Mechanical neck pain is very common among helicopter pilots. Although Air Force and Navy waiver guides recommend nonsteroidal anti-inflammatory medications as well as SMMT and ET, there are currently very few published studies that examine the benefits of manual and exercise therapy for treating mechanical neck pain in commercial and military pilots. Based on the results of this study, it seems that SMMT and ET may be a safe and effective in treatment of uncomplicated mechanical neck pain in helicopter pilots. Alagha B. Conservative management of mechanical neck pain in a helicopter pilot.

Automated matching software for clinical trials eligibility: measuring efficiency and flexibility.

PubMed

Penberthy, Lynne; Brown, Richard; Puma, Federico; Dahman, Bassam

2010-05-01

Clinical trials (CT) serve as the media that translates clinical research into standards of care. Low or slow recruitment leads to delays in delivery of new therapies to the public. Determination of eligibility in all patients is one of the most important factors to assure unbiased results from the clinical trials process and represents the first step in addressing the issue of under representation and equal access to clinical trials. This is a pilot project evaluating the efficiency, flexibility, and generalizibility of an automated clinical trials eligibility screening tool across 5 different clinical trials and clinical trial scenarios. There was a substantial total savings during the study period in research staff time spent in evaluating patients for eligibility ranging from 165h to 1329h. There was a marked enhancement in efficiency with the automated system for all but one study in the pilot. The ratio of mean staff time required per eligible patient identified ranged from 0.8 to 19.4 for the manual versus the automated process. The results of this study demonstrate that automation offers an opportunity to reduce the burden of the manual processes required for CT eligibility screening and to assure that all patients have an opportunity to be evaluated for participation in clinical trials as appropriate. The automated process greatly reduces the time spent on eligibility screening compared with the traditional manual process by effectively transferring the load of the eligibility assessment process to the computer. Copyright (c) 2010 Elsevier Inc. All rights reserved.

Generic Reflective Feedback: An Effective Approach to Developing Clinical Reasoning Skills

ERIC Educational Resources Information Center

Wojcikowski, K.; Brownie, S.

2013-01-01

Problem-based learning can be an effective tool to develop clinical reasoning skills. However, it traditionally takes place in tutorial groups, giving students little flexibility in how and when they learn. This pilot study compared the effectiveness of generic reflective feedback (GRF) with tutorial-based reflective feedback on the development of…

Adaptation of a Cancer Clinical Trials Education Program for African American and Latina/o Community Members

ERIC Educational Resources Information Center

Pelto, Debra J.; Sadler, Georgia Robins; Njoku, Ogo; Rodriguez, Maria Carina; Villagra, Cristina; Malcarne, Vanessa L.; Riley, Natasha E.; Behar, Alma I.; Jandorf, Lina

2016-01-01

The pilot study reported in this article culturally and linguistically adapted an educational intervention to promote cancer clinical trials (CCTs) participation among Latinas/os and African Americans. The single-session slide presentation with embedded videos, originally developed through a campus-community partnership in Southern California, was…

Validation of the Quantitative Diagnostic Thinking Inventory for Athletic Training: A Pilot Study

ERIC Educational Resources Information Center

Kicklighter, Taz; Barnum, Mary; Geisler, Paul R.; Martin, Malissa

2016-01-01

Context: The cognitive process of making a clinical decision lies somewhere on a continuum between novices using hypothetico-deductive reasoning and experts relying more on case pattern recognition. Although several methods exist for measuring facets of clinical reasoning in specific situations, none have been experimentally applied, as of yet, to…

Enhancing Baccalaureate Nursing Students' Perception of Competence and Confidence During an Alternative Dedicated Education Unit Experience: A Pilot Study.

PubMed

Schecter, Rose; Gallagher, Joan; Ryan, Marybeth

This quasiexperimental pilot study explored the effect three consecutive adult health Dedicated Education Unit (DEU) clinical placements would have on baccalaureate nursing students' self-perception of growth in competence and confidence. A Likert-type Competence/Confidence Self-Assessment Scale was constructed as a pretest/posttest measure; competence and confidence posttest means increased in each course. The study provides nursing professional development practitioners with information about the alternative DEU concept, its effect on student outcomes, and benefits nursing staff can gain by participating in a DEU experience.

An exploratory pilot study to design and assess the credibility of a sham kinesiology treatment.

PubMed

Hall, Sue; Lewith, George; Brien, Sarah; Little, Paul

2008-12-01

Kinesiology is a complementary therapy assessing subtle change in manual muscle testing results to select individualised treatments. We report the exploratory 2-stage development and pilot of a sham kinesiology treatment for use in a clinical trial to evaluate the specific effects of this intervention. 1. To design, pilot and assess the credibility of a sham kinesiology treatment in a kinesiology-aware population. 2. To pilot the sham kinesiology in a cross-over study of sham versus real kinesiology, and to make an exploratory assessment of its credibility in a kinesiology-naïve population. 1. 10 kinesiology-aware volunteers received a specially designed sham treatment weekly for 5 weeks which was subject to a credibility assessment. 2. 10 kinesiology-naïve patients with low back pain were randomised to receive 4 real and 4 sham treatments in a cross-over design; the treatments were subject to a credibility assessment. 100% of participants found the sham protocol a credible treatment as measured by the credibility questionnaire. 100% of patients having real treatment first did not recognise that the second set of treatments were sham. Small numbers precluded the use of formal statistical tests. In this small sample it appeared feasible to deliver an apparently credible sham kinesiology treatment. This feasibility study has allowed us to develop a sham treatment for use in a larger prospective clinical trial of kinesiology in patients with low back pain. 2008 S. Karger AG, Basel.

Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

2018-01-01

This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

An Occupation and Participation Approach to Reading Intervention (OPARI) Part II: Pilot Clinical Application

ERIC Educational Resources Information Center

Grajo, Lenin C.; Candler, Catherine

2016-01-01

The Occupation and Participation Approach to Reading Intervention (OPARI) is an intervention approach for children with reading difficulties that emphasizes reading as an important occupation of children. Part I presented the theoretical basis of the OPARI. Part II describes a pilot clinical application of the OPARI. Guided by Schkade and…

Self-regulation workshop and Occupational Performance Coaching with teachers: A pilot study.

PubMed

Hui, Caroline; Snider, Laurie; Couture, Mélanie

2016-04-01

Teachers' occupational role and performance can be undermined when working with students with disruptive classroom behaviours. This pilot study aimed to explore the impact of school-based occupational therapy intervention on teachers' classroom management self-efficacy and perceived performance/satisfaction in their management of students with disruptive behaviours. This pilot study used a multiple-case replication study design. A cohort of regular classroom elementary school teachers (n = 11) participated in a 1-day workshop on sensorimotor strategies for supporting student self-regulation followed by eight individual sessions of Occupational Performance Coaching (OPC). Measurement tools were the Canadian Occupational Performance Measure, Goal Attainment Scaling (GAS), and Teachers' Self-Efficacy Scale-Classroom Management. Improvement in teachers' perception of performance, satisfaction, and classroom management was seen. GAS showed clinically significant improvement. Improvements were sustained at 7 weeks follow-up. Preliminary results support the use of sensorimotor education combined with OPC to enable teachers' occupational performance. © CAOT 2016.

Quantum Physics Principles and Communication in the Acute Healthcare Setting: A Pilot Study.

PubMed

Helgeson, Heidi L; Peyerl, Colleen Kraft; Solheim-Witt, Marit

This pilot study explores whether clinician awareness of quantum physics principles could facilitate open communication between patients and providers. In the spirit of action research, this study was conceptualized with a holistic view of human health, using a mixed method design of grounded theory as an emergent method. Instrumentation includes surveys and a focus group discussion with twelve registered nurses working in an acute care hospital setting. Findings document that the preliminary core phenomenon, energy as information, influences communication in the healthcare environment. Key emergent themes include awareness, language, validation, open communication, strategies, coherence, incoherence and power. Research participants indicate that quantum physics principles provide a language and conceptual framework for improving their awareness of communication and interactions in the healthcare environment. Implications of this pilot study support the feasibility of future research and education on awareness of quantum physics principles in other clinical settings. Copyright © 2016 Elsevier Inc. All rights reserved.

Three Families in Search of a Director: Study of Life of Multi-Family Treatment Group of Three Schizophrenic Families of Diametrically Opposed Life Styles.

ERIC Educational Resources Information Center

Pellman, Renee; Platt, Rhoda

This clinical study describes a pilot experience of Multi-Family Treatment Groups (MFTG) as a treatment modality. The group leaders were two family therapists. Three intact families with completely different life styles, all chronically malfunctioning, and with previously unsuccessful treatment were chosen at random from the Clinic intake. The…

Statistical analysis plan of the head position in acute ischemic stroke trial pilot (HEADPOST pilot).

PubMed

Olavarría, Verónica V; Arima, Hisatomi; Anderson, Craig S; Brunser, Alejandro; Muñoz-Venturelli, Paula; Billot, Laurent; Lavados, Pablo M

2017-02-01

Background The HEADPOST Pilot is a proof-of-concept, open, prospective, multicenter, international, cluster randomized, phase IIb controlled trial, with masked outcome assessment. The trial will test if lying flat head position initiated in patients within 12 h of onset of acute ischemic stroke involving the anterior circulation increases cerebral blood flow in the middle cerebral arteries, as measured by transcranial Doppler. The study will also assess the safety and feasibility of patients lying flat for ≥24 h. The trial was conducted in centers in three countries, with ability to perform early transcranial Doppler. A feature of this trial was that patients were randomized to a certain position according to the month of admission to hospital. Objective To outline in detail the predetermined statistical analysis plan for HEADPOST Pilot study. Methods All data collected by participating researchers will be reviewed and formally assessed. Information pertaining to the baseline characteristics of patients, their process of care, and the delivery of treatments will be classified, and for each item, appropriate descriptive statistical analyses are planned with comparisons made between randomized groups. For the outcomes, statistical comparisons to be made between groups are planned and described. Results This statistical analysis plan was developed for the analysis of the results of the HEADPOST Pilot study to be transparent, available, verifiable, and predetermined before data lock. Conclusions We have developed a statistical analysis plan for the HEADPOST Pilot study which is to be followed to avoid analysis bias arising from prior knowledge of the study findings. Trial registration The study is registered under HEADPOST-Pilot, ClinicalTrials.gov Identifier NCT01706094.

A Pilot Study of CPAP Adherence Promotion by Peer Buddies with Sleep Apnea

PubMed Central

Parthasarathy, Sairam; Wendel, Christopher; Haynes, Patricia L.; Atwood, Charles; Kuna, Samuel

2013-01-01

Study Objectives: To evaluate patient ratings of the acceptability of a peer buddy system (PBS). To promote continuous positive airway pressure (CPAP) therapy adherence in patients with obstructive sleep apnea (OSA). To obtain preliminary data on the effectiveness of PBS on sleep-specific health-related quality of life and CPAP adherence. Design: Prospective, randomized, and controlled study. Setting: Academic Center. Participants: Thirty-nine patients with OSA and 13 patients with OSA who were experienced CPAP users. Interventions: Recently diagnosed patients with OSA were randomly assigned to either the PBS to promote CPAP adherence (intervention group) or usual care (control group). Measurements: Patient satisfaction, Functional Outcomes of Sleep Questionnaire (FOSQ), CPAP adherence, vigilance, self-efficacy, and patient activation were measured. Results: Ninety-one percent of the subjects rated the PBS as very satisfactory (68%) or satisfactory (23%). During the 90 days of therapy, weekly CPAP adherence was greater in the intervention than the usual care group (MANOVA; F = 2.29; p = 0.04). Patient satisfaction was positively correlated with CPAP adherence (R2 = 0.14; p = 0.02). We did not find any group differences for FOSQ, vigilance, self-efficacy, or patient activation in this pilot study. Conclusion: Our pilot study suggests that the PBS intervention is feasible and received high patient satisfaction ratings. CPAP adherence may be improved by peer-driven intervention, but a larger, adequately powered study is needed. Clinical Trial Information: ClinicalTrials.gov identifier: NCT01164683. Commentary: A commentary on this article appears in this issue on page 551. Citation: Parthasarathy S; Wendel C; Haynes PL; Atwood C; Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med 2013;9(6):543-550. PMID:23772186

Prospective trial of an herbal formula BYSH and Saw palmetto in patients with hormonal refractory prostate cancer: a pilot study.

PubMed

Ng, Anthony C-F; Cheng, K-F; Leung, P-C

2014-01-01

BYSH, a herbal formula, was evaluated for efficacy and safety in a pilot study for patients with advanced hormone refractory prostate cancer (HRPC). The pilot study was designed as a single-center open-label trial. Patients with HRPC were treated with BYSH for 24 weeks. The primary end point was the changes in serum prostate-specific antigen (PSA) level. Safety parameters such as liver and renal functions were monitored during the study period. Ten patients were eligible for the study. Most of them had stable PSA levels while taking BYSH. However, at the end of the BYSH treatment, the level of PSA increased. The median survival from diagnosis of HRPC was 16.4 months. Liver and renal functions remained normal. BYSH was well tolerated and no patient reported adverse events during the study period. Although it is inappropriate to make a conclusion based on the pilot study results, the trend of improvement is obvious. Further investigations should be conducted to demonstrate its clinical benefits. We have also briefly reviewed some plant products which are patented and also available in market.

Spinal injury after ejection in jet pilots: mechanism, diagnosis, followup, and prevention.

PubMed

Rotondo, G

1975-06-01

In order to contribute to the study of spinal injury after ejection., the author analyzed the results of 100 cases of ejections carried out by military and civil Italian jet pilots in a period of 20 years. Of this group, 47 successfully ejected from aircraft without injury; 11 ejections proved fatal. The remaining 42 pilots sutained vertebral fractures, while 27 sustained other traumatic injuries different from spinal fractures. There were 23 vertebral fractures in 15 pilots and the most frequently affected vertebrae were those of the thoraco-lumbar junction. Analysis was make of the pathology, the clinical and radiological profiles, the therapeutic treatment, and the relative aeromedico-legal aspects concerning the temporary unfitness for flying or permanent grounding of the personnel as well as the possible prevention of spinal injury after ejection

Validity and reliability of a pilot scale for assessment of multiple system atrophy symptoms.

PubMed

Matsushima, Masaaki; Yabe, Ichiro; Takahashi, Ikuko; Hirotani, Makoto; Kano, Takahiro; Horiuchi, Kazuhiro; Houzen, Hideki; Sasaki, Hidenao

2017-01-01

Multiple system atrophy (MSA) is a rare progressive neurodegenerative disorder for which brief yet sensitive scale is required in order for use in clinical trials and general screening. We previously compared several scales for the assessment of MSA symptoms and devised an eight-item pilot scale with large standardized response mean [handwriting, finger taps, transfers, standing with feet together, turning trunk, turning 360°, gait, body sway]. The aim of the present study is to investigate the validity and reliability of a simple pilot scale for assessment of multiple system atrophy symptoms. Thirty-two patients with MSA (15 male/17 female; 20 cerebellar subtype [MSA-C]/12 parkinsonian subtype [MSA-P]) were prospectively registered between January 1, 2014 and February 28, 2015. Patients were evaluated by two independent raters using the Unified MSA Rating Scale (UMSARS), Scale for Assessment and Rating of Ataxia (SARA), and the pilot scale. Correlations between UMSARS, SARA, pilot scale scores, intraclass correlation coefficients (ICCs), and Cronbach's alpha coefficients were calculated. Pilot scale scores significantly correlated with scores for UMSARS Parts I, II, and IV as well as with SARA scores. Intra-rater and inter-rater ICCs and Cronbach's alpha coefficients remained high (> 0.94) for all measures. The results of the present study indicate the validity and reliability of the eight-item pilot scale, particularly for the assessment of symptoms in patients with early state multiple system atrophy.

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.

A Pilot Test of the Additive Benefits of Physical Exercise to CBT for OCD.

PubMed

Rector, Neil A; Richter, Margaret A; Lerman, Bethany; Regev, Rotem

2015-01-01

The majority of "responders" to first-line cognitive-behavioural therapy (CBT) and pharmacological treatments for obsessive-compulsive disorder (OCD) are left with residual symptoms that are clinically relevant and disabling. Therefore, there is pressing need for widely accessible efficacious alternative and/or adjunctive treatments for OCD. Accumulating evidence suggests that physical exercise may be one such intervention in the mood and anxiety disorders broadly, although we are aware of only two positive small-scale pilot studies that have tested its clinical benefits in OCD. This pilot study aimed to test the feasibility and preliminary efficacy of adding a structured physical exercise programme to CBT for OCD. A standard CBT group was delivered concurrently with a 12-week customized exercise programme to 11 participants. The exercise regimen was individualized for each participant based on peak heart rate measured using an incremental maximal exercise test. Reports of exercise adherence across the 12-week regimen exceeded 80%. A paired-samples t-test indicated very large treatment effects in Yale-Brown Obsessive-Compulsive Scale scores from pre- to post-treatment in CBT group cohorts led by expert CBT OCD specialists (d = 2.55) and junior CBT clinician non-OCD specialists (d = 2.12). These treatment effects are very large and exceed effects typically observed with individual and group-based CBT for OCD based on leading meta-analytic reviews, as well as previously obtained treatment effects for CBT using the same recruitment protocol without exercise. As such, this pilot work demonstrates the feasibility and significant potential clinical utility of a 12-week aerobic exercise programme delivered in conjunction with CBT for OCD.

Enabling recruitment success in bariatric surgical trials: pilot phase of the By-Band-Sleeve study.

PubMed

Paramasivan, S; Rogers, C A; Welbourn, R; Byrne, J P; Salter, N; Mahon, D; Noble, H; Kelly, J; Mazza, G; Whybrow, P; Andrews, R C; Wilson, C; Blazeby, J M; Donovan, J L

2017-11-01

Randomized controlled trials (RCTs) involving surgical procedures are challenging for recruitment and infrequent in the specialty of bariatrics. The pilot phase of the By-Band-Sleeve study (gastric bypass versus gastric band versus sleeve gastrectomy) provided the opportunity for an investigation of recruitment using a qualitative research integrated in trials (QuinteT) recruitment intervention (QRI). The QRI investigated recruitment in two centers in the pilot phase comparing bypass and banding, through the analysis of 12 in-depth staff interviews, 84 audio recordings of patient consultations, 19 non-participant observations of consultations and patient screening data. QRI findings were developed into a plan of action and fed back to centers to improve information provision and recruitment organization. Recruitment proved to be extremely difficult with only two patients recruited during the first 2 months. The pivotal issue in Center A was that an effective and established clinical service could not easily adapt to the needs of the RCT. There was little scope to present RCT details or ensure efficient eligibility assessment, and recruiters struggled to convey equipoise. Following presentation of QRI findings, recruitment in Center A increased from 9% in the first 2 months (2/22) to 40% (26/65) in the 4 months thereafter. Center B, commencing recruitment 3 months after Center A, learnt from the emerging issues in Center A and set up a special clinic for trial recruitment. The trial successfully completed pilot recruitment and progressed to the main phase across 11 centers. The QRI identified key issues that enabled the integration of the trial into the clinical setting. This contributed to successful recruitment in the By-Band-Sleeve trial-currently the largest in bariatric practice-and offers opportunities to optimize recruitment in other trials in bariatrics.

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.

Using video feedback to improve early father–infant interaction: A pilot study

PubMed Central

Davies, Beverley; Ramchandani, Paul G.

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child’s thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers’ feedback was generally positive. The flexibility to conduct sessions at home (or at fathers’ places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers. PMID:22434935

Reducing safety risk among underserved caregivers with an Alzheimer's home safety program.

PubMed

Levy-Storms, Lené; Cherry, Debra L; Lee, Linda J; Wolf, Sheldon M

2017-09-01

Older adults living with Alzheimer's disease (AD) experience more of the types of accidents and injuries prevalent among older adults. Relatively few studies specifically on safety risks have included older adults of color and tested interventions. This pilot study tested the feasibility and evaluability of educating Hispanic and African American caregivers of patients living with AD about reducing safety risks in their homes. This outpatient memory clinic-based intervention study included a pre-/post-test survey design with two nonequivalent groups and predominately serves Hispanic and African Americans. Of 60 eligible caregivers, 67% participated in a tailored, safety training class with an optional follow-up call. The results indicate a reduction in some safety risks compared to baseline and/or a no intervention group, respectively, including leaving patients at home alone part-time (p < .01 and p < .01), getting lost (p < .05 and p < .05), going outdoors alone less often (p < .05 and p < .01), and giving themselves medicine (p < .05 and p < .01). At post-test, 47 clinically significant instances occurred, in which caregivers who participated in the intervention self-reported patients living with AD to be 'completely safe' in one or more of the safety risk items compared to 8 instances among those who did not. This pilot pre/post design with non-equivalent groups study needs refinement in a future randomized control trial. Despite limitations, this pilot study demonstrates the first feasible and evaluable intervention with both statistically and clinically significant results that suggest potential for reducing safety risks among at-risk minority patients living with AD in future research.

The impact of an interprofessional problem-based learning curriculum of clinical ethics on medical and nursing students' attitudes and ability of interprofessional collaboration: a pilot study.

PubMed

Lin, Yu-Chih; Chan, Te-Fu; Lai, Chung-Sheng; Chin, Chi-Chun; Chou, Fan-Hao; Lin, Hui-Ju

2013-09-01

Clinical ethic situations in modern multiprofessional healthcare systems may involve different healthcare professions who work together for patient care. The undergraduate interprofessional education of clinical ethics would help to incubate healthcare students' ability of interprofessional collaboration in solving ethical problems. However, the impact from an interprofessional educational model on student's attitudes and confidence of interprofessional collaboration should be carefully evaluated during the process of curricular development. This study aimed to conduct a pilot interprofessional PBL curriculum of clinical ethics and evaluate the curricular impact on interprofessional students' attitude and confidence of collaborative teamwork. Thirty-six medical and nursing students volunteered to participate in this study and were divided into three groups (medical group, nursing group, and mixed group). Tutors were recruited from the Medical School and the College of Nursing. The pilot curriculum included one lecture of clinical ethics, one PBL case study with two tutorial sessions, and one session of group discussion and feedback. A narrative story with multiple story lines and a multiperspective problem analysis tool were used in the PBL tutorials. The students' self-evaluation of learning questionnaire was used to evaluate students' learning of clinical ethics and interprofessional collaborative skills and attitude. The internal consistency of the questionnaire was measured by Cronbach α, and the criterion-related validity of the questionnaire was evaluated through associations between the dimension scores with the student group by one-way analysis of variance test (ANOVA) test and Tukey-Kramer honestly significant difference (HSD) comparison. There was significant difference among different groups in students' ability and attitudes about "interprofessional communication and collaboration" (p = 0.0184). The scores in the mixed group (37.58 ± 3.26) were higher than the medical group (32.10 ± 4.98). In conclusion, our model for the interprofessional PBL curriculum of clinical ethics is practicable and will produce positive impacts on students' attitudes and confidence of interprofessional collaboration. Copyright © 2013. Published by Elsevier B.V.

Interprofessional student clinics: an economic evaluation of collaborative clinical placement education.

PubMed

Haines, Terry P; Kent, Fiona; Keating, Jennifer L

2014-07-01

Interprofessional student clinics can be used to create clinical education placements for health professional students in addition to traditional hospital-based placements and present an opportunity to provide interprofessional learning experiences in a clinical context. To date, little consideration has been given in research literature as to whether such clinics are economically viable for a university to run. We conducted an economic evaluation based upon data generated during a pilot of an interprofessional student clinic based in Australia. Cost-minimization analyses of the student clinic as opposed to traditional profession-specific clinical education in hospitals were conducted from university, Commonwealth Government, state government and societal perspectives. Cost data gathered during the pilot study and market prices were used where available, while $AUD currency at 2011 values were used. Per student day of clinical education, the student clinic cost an additional $289, whereas the state government saved $49 and the Commonwealth Government saved $66. Overall, society paid an additional $175 per student day of clinical education using the student clinic as opposed to conventional hospital-based placements, indicating that traditional hospital-based placements are a cost-minimizing approach overall for providing clinical education. Although interprofessional student clinics have reported positive patient and student learning outcomes, further research is required to determine if these benefits can justify the additional cost of this model of education. Considerations for clinic sustainability are proposed.

Telehealth for diabetes self-management education and support in an underserved, free clinic population: A pilot study.

PubMed

Threatt, Tiffaney B; Ward, Eileen D

Primary study objectives were to (1) describe mean change in A1c from baseline of a free clinic population enrolled in telehealth diabetes self-management education and support (DSME/S) services and (2) to compare change in A1C and other clinical outcomes measures with free clinic patients enrolled in a traditional face-to-face DSME/S program. An exploratory study design and comparative evaluation of telehealth DSME/S services in a free clinic population was used. Baseline clinical measures were collected upon referral. Diabetes educators met with patients individually over 2-3 months. Clinical outcomes measures were collected within 6 months of program completion. Data from the telehealth group was assessed individually and compared to a free clinic traditional DSME/S program population. Twelve patients completed a telehealth free clinic DSME/S pilot program with a mean ± SD change in A1C from baseline of -1.03 ± 1.53% (P = 0.050). Mean ± SD change in A1C from baseline in the free clinic population participating in traditional face-to-face DSME/S services was -1.42 ± 1.80% (P = 0.001). No significant differences in secondary outcomes measures, including body mass index and blood pressure, were revealed among the study populations. Expanding access to care in populations faced with challenges of socioeconomics, limited education, and lower health literacy is a step toward reducing health disparities and positively affecting care. Mean A1C can be improved with telehealth DSME/S services in an underserved, free clinic population. Copyright © 2017 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

Evaluation of a filmed clinical scenario as a teaching resource for an introductory pharmacology unit for undergraduate health students: A pilot study.

PubMed

East, Leah; Hutchinson, Marie

2015-12-01

Simulation is frequently being used as a learning and teaching resource for both undergraduate and postgraduate students, however reporting of the effectiveness of simulation particularly within the pharmacology context is scant. The aim of this pilot study was to evaluate a filmed simulated pharmacological clinical scenario as a teaching resource in an undergraduate pharmacological unit. Pilot cross-sectional quantitative survey. An Australian university. 32 undergraduate students completing a healthcare degree including nursing, midwifery, clinical science, health science, naturopathy, and osteopathy. As a part of an undergraduate online pharmacology unit, students were required to watch a filmed simulated pharmacological clinical scenario. To evaluate student learning, a measurement instrument developed from Bloom's cognitive domains (knowledge, comprehension, application, analysis, synthesis and evaluation) was employed to assess pharmacological knowledge conceptualisation and knowledge application within the following fields: medication errors; medication adverse effects; medication interactions; and, general pharmacology. The majority of participants were enrolled in an undergraduate nursing or midwifery programme (72%). Results demonstrated that the majority of nursing and midwifery students (56.52%) found the teaching resource complementary or more useful compared to a lecture although less so compared to a tutorial. Students' self-assessment of learning according to Bloom's cognitive domains indicated that the filmed scenario was a valuable learning tool. Analysis of variance indicated that health science students reported higher levels of learning compared to midwifery and nursing. Students' self-report of the learning benefits of a filmed simulated clinical scenario as a teaching resource suggest enhanced critical thinking skills and knowledge conceptualisation regarding pharmacology, in addition to being useful and complementary to other teaching and learning methods. Copyright © 2015 Elsevier Ltd. All rights reserved.

Sibanye Methods for Prevention Packages Program Project Protocol: Pilot Study of HIV Prevention Interventions for Men Who Have Sex With Men in South Africa.

PubMed

McNaghten, Ad; Kearns, Rachel; Siegler, Aaron J; Phaswana-Mafuya, Nancy; Bekker, Linda-Gail; Stephenson, Rob; Baral, Stefan D; Brookmeyer, Ron; Yah, Clarence S; Lambert, Andrew J; Brown, Benjamin; Rosenberg, Eli; Blalock Tharp, Mondie; de Voux, Alex; Beyrer, Chris; Sullivan, Patrick S

2014-10-16

Human immunodeficiency virus (HIV) prevention intervention programs and related research for men who have sex with men (MSM) in the southern African region remain limited, despite the emergence of a severe epidemic among this group. With a lack of understanding of their social and sexual lives and HIV risks, and with MSM being a hidden and stigmatized group in the region, optimized HIV prevention packages for southern African MSM are an urgent public health and research priority. The objective of the Sibanye Health Project is to develop and evaluate a combination package of biomedical, behavioral, and community-level HIV prevention interventions and services for MSM in South Africa. The project consists of three phases: (1) a comprehensive literature review and summary of current HIV prevention interventions (Phase I), (2) agent-based mathematical modeling of HIV transmission in southern African MSM (Phase II), and (3) formative and stigma-related qualitative research, community engagement, training on providing health care to MSM, and the pilot study (Phase III). The pilot study is a prospective one-year study of 200 men in Cape Town and Port Elizabeth, South Africa. The study will assess a package of HIV prevention services, including condom and condom-compatible lubricant choices, risk-reduction counseling, couples HIV testing and counseling, pre-exposure prophylaxis (PrEP) for eligible men, and non-occupational post-exposure prophylaxis for men with a high risk exposure. The pilot study will begin in October 2014. Preliminary results from all components but the pilot study are available. We developed a literature review database with meta-data extracted from 3800 documents from 67 countries. Modeling results indicate that regular HIV testing and promotion of condom use can significantly impact new HIV infections among South African MSM, even in the context of high coverage of early treatment of HIV-positive men and high coverage of PrEP for at-risk HIV-negative men. Formative qualitative research consisted of 79 in-depth interviews, and six focus group discussions in Cape Town and Port Elizabeth. Analysis of these data has informed pilot study protocol development and has been documented in peer-reviewed manuscripts. Qualitative work regarding stigma faced by South African MSM resulted in finalized scales for use in the pilot study questionnaire. A total of 37 health care providers completed training designed to facilitate clinically and culturally competent care for MSM in the Eastern Cape. The design of a future, larger study of the HIV prevention package will be conducted at the end of the pilot study, powered to detect efficacy of the prevention package. Data from the updated mathematical model, results of the pilot study, acceptability data, and advancements in HIV prevention sciences will be considered in developing the final proposed package and study design. ClinicalTrials.gov NCT02043015; http://clinicaltrials.gov/show/NCT02043015 (Archived by WebCite at http://www.webcitation.org/6THvp7rAj).

[Pilot tests using molecular diagnostic assay cervicovaginal infection during pregnancy].

PubMed

Beltrán-Montoya, J; Escudero-Gontes, S; Martínez-Huerta, N E; Ávila-Vergara, M A; Morales-Hernández, V; Canchola-Sotelo, C; Palacios-González, B; Vadillo-Ortega, F

2016-08-01

The prevalence of cervicovaginal infections during pregnancy has been associated with adverse perinatal outcomes however, the actual approach used for diagnosis is not effective. The aim of this study was to compare the diagnosis of vaginal infections in pregnant women using clinical, molecular diagnostic and traditional microbiological culture in a pilot study, to determine the prevalence and association with the development of preterm labor. We performed a nested cross-sectional study composed by 54 women in a cohort of pregnant women in Mexico City. Cervicovaginal infections were evaluated by clinical methods, microbiology culture and a commercially available molecular biology test. Prevalence of cervicovaginal infections during pregnancy was estimated between 28% and 50% according to methodologies. Considering the clinical diagnosis of preterm labor as the gold standard, all diagnostic tests were poor as predictors of preterm labor. Traditional approaches to establish the significance of cervicovaginal infection in pregnancy are exhausted, so be sought new ways to understand this complex relationship. Meanwhile it is recommended to continue to use traditional methods to identify infections during pregnancy in both knowledge of new methods aimed at understanding these relationships are sophisticated.

A Pilot Study of Neurofeedback for Chronic PTSD.

PubMed

Gapen, Mark; van der Kolk, Bessel A; Hamlin, Ed; Hirshberg, Laurence; Suvak, Michael; Spinazzola, Joseph

2016-09-01

EEG Biofeedback (also known as neurofeedback) has been in use as a clinical intervention for well over 30 years; however, it has made very little impact on clinical care. One reason for this has been the difficulty in designing research to measure clinical change in the real world. While substantial evidence exists for its efficacy in treating attention deficit/hyperactivity disorder, relatively little evidence exists for its utility in other disorders including posttraumatic stress disorder (PTSD). The current study represents a "proof-of-concept" pilot for the use of neurofeedback with multiply-traumatized individuals with treatment-resistant PTSD. Participants completed 40 sessions of neurofeedback training two times per week with sensors randomly assigned (by the study coordinator, who was not blind to condition) to sensor placements of either T4-P4 or T3-T4. We found that neurofeedback significantly reduced PTSD symptoms (Davidson Trauma Scale scores averaged 69.14 at baseline to 49.26 at termination), and preceded gains in affect regulation (Inventory of Altered Self-Capacities-Affect Dysregulation scores averaged 23.63 at baseline to 17.20 at termination). We discuss a roadmap for future research.

The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

PubMed

Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

2016-05-01

Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

A Clinical Pharmacist's Role in Screening for Metabolic Syndrome in a Rural Pediatric Ambulatory Clinic

ERIC Educational Resources Information Center

Benavides, Sandra; Kohler, Lisa A.; Souffrant, Garry

2011-01-01

Purpose: The prevalence of metabolic syndrome in the pediatric population is increasing. Barriers, including the lack of consensus of a definition for metabolic syndrome and time constraints for the pediatrician, may limit the identification and diagnosis of metabolic syndrome in children. The objective of this pilot study was to evaluate the role…

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...

Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

2008-01-01

No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

Analysis of the relationship between periodontal disease and atherosclerosis within a local clinical system: a cross-sectional observational pilot study.

PubMed

Kudo, Chieko; Shin, Wee Soo; Minabe, Masato; Harai, Kazuo; Kato, Kai; Seino, Hiroaki; Goke, Eiji; Sasaki, Nobuhiro; Fujino, Takemasa; Kuribayashi, Nobuichi; Pearce, Youko Onuki; Taira, Masato; Maeda, Hiroshi; Takashiba, Shogo

2015-09-01

It has been revealed that atherosclerosis and periodontal disease may have a common mechanism of "chronic inflammation". Several reports have indicated that periodontal infection is related to atherosclerosis, but none have yet reported such an investigation through the cooperation of local clinics. This study was performed in local Japanese clinics to examine the relationship between periodontal disease and atherosclerosis under collaborative medical and dental care. A pilot multicenter cross-sectional study was conducted on 37 medical patients with lifestyle-related diseases under consultation in participating medical clinics, and 79 periodontal patients not undergoing medical treatment but who were seen by participating dental clinics. Systemic examination and periodontal examination were performed at baseline, and the relationships between periodontal and atherosclerosis-related clinical markers were analyzed. There was a positive correlation between LDL-C level and plasma IgG antibody titer to Porphyromonas gingivalis. According to the analysis under adjusted age, at a cut-off value of 5.04 for plasma IgG titer to Porphyromonas gingivalis, the IgG titer was significantly correlated with the level of low-density lipoprotein cholesterol (LDL-C). This study suggested that infection with periodontal bacteria (Porphyromonas gingivalis) is associated with the progression of atherosclerosis. Plasma IgG titer to Porphyromonas gingivalis may be useful as the clinical risk marker for atherosclerosis related to periodontal disease. Moreover, the application of the blood examination as a medical check may lead to the development of collaborative medical and dental care within the local medical clinical system for the purpose of preventing the lifestyle-related disease.

‘Act on Oncology’ as a New Comprehensive Approach to Assess Prostate Cancer Centres – Method Description and Results of a Pilot Study

PubMed Central

Voigt, Wieland; Hoellthaler, Josef; Magnani, Tiziana; Corrao, Vito; Valdagni, Riccardo

2014-01-01

Background Multidisciplinary care of prostate cancer is increasingly offered in specialised cancer centres. It requires the optimisation of medical and operational processes and the integration of the different medical and non-medical stakeholders. Objective To develop a standardised operational process assessment tool basing on the capability maturity model integration (CMMI) able to implement multidisciplinary care and improve process quality and efficiency. Design, Setting, and Participants Information for model development was derived from medical experts, clinical guidelines, best practice elements of renowned cancer centres, and scientific literature. Data were organised in a hierarchically structured model, consisting of 5 categories, 30 key process areas, 172 requirements, and more than 1500 criteria. Compliance with requirements was assessed through structured on-site surveys covering all relevant clinical and management processes. Comparison with best practice standards allowed to recommend improvements. ‘Act On Oncology’(AoO) was applied in a pilot study on a prostate cancer unit in Europe. Results and Limitations Several best practice elements such as multidisciplinary clinics or advanced organisational measures for patient scheduling were observed. Substantial opportunities were found in other areas such as centre management and infrastructure. As first improvements the evaluated centre administration described and formalised the organisation of the prostate cancer unit with defined personnel assignments and clinical activities and a formal agreement is being worked on to have structured access to First-Aid Posts. Conclusions In the pilot study, the AoO approach was feasible to identify opportunities for process improvements. Measures were derived that might increase the operational process quality and efficiency. PMID:25192213

Bruxism in military pilots and non-pilots: tooth wear and psychological stress.

PubMed

Lurie, Orit; Zadik, Yehuda; Einy, Shmuel; Tarrasch, Ricardo; Raviv, Gil; Goldstein, Liav

2007-02-01

Bruxism is the diurnal or nocturnal para-functional habit of clenching or grinding the teeth and affects 5-10% of the general western population. Bruxism can cause pain and irreversible damage to the teeth, periodontium, masticatory muscles, and temporo-mandibular joint. Variables such as general stress, work-related stress, and personality traits have been increasingly considered as initiating, predisposing, and perpetuating factors for bruxism. We sought to evaluate the potential of work-related stress and personality factors to induce bruxism among military pilots and non-pilot officers. Subjects were 57 healthy male Israel Air Force officers (mean age 25.8+/-4.3 yr). Of these, 17 were jet-pilots, 18 helicopter-pilots, and 22 non-pilot officers. Tooth-wear was classified according to a six-point scale. In addition, the subjects responded to a battery of psychological questionnaires for self-assessment of stress at the workplace and their coping behavior. Bruxism of clinical importance (i.e., with dentin exposure) was found in 69% of the aircrew members but only 27% of the non-pilot group. No difference was found between groups regarding stress levels. Military aircrews may be relatively vulnerable to deleterious bruxism as well as other signs of chronic stress. Among bruxers, pilots tended to show coping strategies that were significantly more emotional and less task-oriented than non-pilots, whereas non-bruxers showed no significant differences in coping behavior. This study suggest that integrating dental and psychological preventive intervention may be helpful.

A clinical evaluation of mineral trioxide aggregate for root-end closure of non-vital immature permanent incisors in children-a pilot study.

PubMed

Sarris, Spyridoula; Tahmassebi, Jinous F; Duggal, Monty S; Cross, Ian A

2008-02-01

The aim of this pilot study was to evaluate the clinical efficacy of mineral trioxide aggregate (MTA) as an apexification material when used in non-vital immature permanent incisors in children. Fifteen children with a mean age of 11.7 years and 17 non-vital permanent incisors were ajudged suitable for inclusion. Standard endodontic procedures were followed and an apical plug of 3-4 mm was created by using MTA after a calcium hydroxide intracanal dressing had been applied for at least 1 week. Final obturation was completed by using thermoplastisized Gutta-Percha (Obtura II) at least 1 week following MTA placement. Subjects were reviewed clinically and radiographically at 3-month intervals. Mean follow-up time for MTA was 12.53 months (+/-2.94 SD). Of the total of 17 teeth treated, MTA placement was considered to be adequate in 13 teeth. The procedure showed clinical success in 94.1% of the cases, radiographic success was found to be 76.5% and in further three cases (17.6%) the outcome was considered to be uncertain. This is one of the very few studies that have reported the out coming of MTA as an apexification material in children with non-vital teeth and incomplete root development. However, larger clinical studies are required to evaluate the long-term success of this procedure.

A listening skill educational intervention for pediatric rehabilitation clinicians: A mixed-methods pilot study.

PubMed

King, Gillian; Servais, Michelle; Shepherd, Tracy A; Willoughby, Colleen; Bolack, Linda; Moodie, Sheila; Baldwin, Patricia; Strachan, Deborah; Knickle, Kerry; Pinto, Madhu; Parker, Kathryn; McNaughton, Nancy

2017-01-01

To prepare for an RCT by examining the effects of an educational intervention on the listening skills of pediatric rehabilitation clinicians, piloting study procedures, and investigating participants' learning experiences. Six experienced clinicians received the intervention, consisting of video simulations and solution-focused coaching regarding personal listening goals. Self- and observer-rated measures of listening skill were completed and qualitative information was gathered in interviews and a member checking session. Significant change on self-reported listening skills was found from pre- to post-test and/or follow-up. The pilot provided useful information to improve the study protocol, including the addition of an initial orientation to listening skills. Participants found the intervention to be a highly valuable and intense learning experience, and reported immediate changes to their clinical and interprofessional practice. The educational intervention has the potential to be an effective means to enhance the listening skills of practicing pediatric rehabilitation clinicians.

Development and Validation of a Primary Care-Based Family Health History and Decision Support Program (MeTree)

PubMed Central

Orlando, Lori A.; Buchanan, Adam H.; Hahn, Susan E.; Christianson, Carol A.; Powell, Karen P.; Skinner, Celette Sugg; Chesnut, Blair; Blach, Colette; Due, Barbara; Ginsburg, Geoffrey S.; Henrich, Vincent C.

2016-01-01

INTRODUCTION Family health history is a strong predictor of disease risk. To reduce the morbidity and mortality of many chronic diseases, risk-stratified evidence-based guidelines strongly encourage the collection and synthesis of family health history to guide selection of primary prevention strategies. However, the collection and synthesis of such information is not well integrated into clinical practice. To address barriers to collection and use of family health histories, the Genomedical Connection developed and validated MeTree, a Web-based, patient-facing family health history collection and clinical decision support tool. MeTree is designed for integration into primary care practices as part of the genomic medicine model for primary care. METHODS We describe the guiding principles, operational characteristics, algorithm development, and coding used to develop MeTree. Validation was performed through stakeholder cognitive interviewing, a genetic counseling pilot program, and clinical practice pilot programs in 2 community-based primary care clinics. RESULTS Stakeholder feedback resulted in changes to MeTree’s interface and changes to the phrasing of clinical decision support documents. The pilot studies resulted in the identification and correction of coding errors and the reformatting of clinical decision support documents. MeTree’s strengths in comparison with other tools are its seamless integration into clinical practice and its provision of action-oriented recommendations guided by providers’ needs. LIMITATIONS The tool was validated in a small cohort. CONCLUSION MeTree can be integrated into primary care practices to help providers collect and synthesize family health history information from patients with the goal of improving adherence to risk-stratified evidence-based guidelines. PMID:24044145

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

PubMed

Haga, Susanne B; Allen LaPointe, Nancy M; Moaddeb, Jivan; Mills, Rachel; Patel, Mahesh; Kraus, William E

2014-11-01

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

The importance of a supportive environment in clinical audit: a pilot study of doctors' engagement with the NHS National PET-CT audit programme.

PubMed

Ross, Peter; Hubert, Jane; Saunders, Mike; Wong, Wai Lup

2014-10-01

The NHS National PET-CT Audit Programme was launched in 2008 as part of a national NHS programme to widen patient access to PET-computed tomography (CT) imaging in England. However, to implement clinical audit effectively, healthcare professionals need to be fully engaged with the process. The purpose of the pilot study was to identify and explore the different factors that influence doctors' engagement with the National NHS PET-CT Audit Programme. A single embedded case study was undertaken, which centred on the NHS National PET-CT Audit Programme. Seven theoretical propositions drawn from a review of the literature were tested and their influence evaluated. A purposeful sample of 13 semistructured interviews with consultant doctors was taken from different hospitals over a 6-month period. The data were analysed using directed thematic content analysis, with the themes compared against the study's propositions. Doctors' perspectives of clinical audit changed in response to the way in which the audit was implemented. The main barriers to engagement were the lack of a common vision and poor communication, which contributed to poor interprofessional relationships and a perceived culture of blame. In contrast, factors that facilitated engagement centred on the adoption of a more supportive and collaborative approach, which in turn facilitated higher levels of trust between professionals. The dissemination of performance data was found to be a key influencing factor. The study makes use of a unique data set and to the best of our knowledge is one of the first studies to document how the dissemination of doctors' performance data positively influences engagement with clinical audit in England. In addition, the study also shows how, contrary to some studies in the literature, clinical audit can reduce professional anxiety by providing a validation of professional competence. The study supports the premise that clinical audit will be fully embraced by doctors only if they are sufficiently involved in the process so as to be able to redefine and clarify its purpose and meaning. The preliminary findings of this pilot study provide the theoretical underpinning for a national survey into reporter perspectives of the National PET-CT Audit Programme.

Observing the work of the Clinical Nurse Specialist: a pilot study.

PubMed

Darmody, Julie V

2005-01-01

The Clinical Nurse Specialist (CNS) is an advanced practice nurse (APN) with graduate preparation as a clinical expert within a specialty area of nursing practice. There is a need for information about the work of the CNS in order to link CNS activities to outcomes and costs of care. To describe the work of the CNS in the acute care setting using the National Association of Clinical Nurse Specialists (NACNS) model as an organizing framework. Descriptive pilot study of the work of the CNS in acute care. A 500-bed academic medical center located in the Midwestern United States. Five masters-prepared APNs in a unit-based CNS role. Direct observation and time study were used to record activities and time for 4 hours with each CNS (n = 5) for a total of 20 hours of observation. CNS activity and time within each practice domain included patient/client (30%), nursing (44%), organization/system (10%), and other activities (16%). Specific activities observed were linked to possible outcomes in the NACNS framework. The NACNS model provided a useful framework for developing a data collection tool that can be used in a larger study that analyzes the work of the acute care CNS. Describing the work of the CNS is an important preliminary step to measuring outcomes and costs of care.

Developing a Web-Based Nursing Practice and Research Information Management System: A Pilot Study.

PubMed

Choi, Jeeyae; Lapp, Cathi; Hagle, Mary E

2015-09-01

Many hospital information systems have been developed and implemented to collect clinical data from the bedside and have used the information to improve patient care. Because of a growing awareness that the use of clinical information improves quality of care and patient outcomes, measuring tools (electronic and paper based) have been developed, but most of them require multiple steps of data collection and analysis. This necessitated the development of a Web-based Nursing Practice and Research Information Management System that processes clinical nursing data to measure nurses' delivery of care and its impact on patient outcomes and provides useful information to clinicians, administrators, researchers, and policy makers at the point of care. This pilot study developed a computer algorithm based on a falls prevention protocol and programmed the prototype Web-based Nursing Practice and Research Information Management System. It successfully measured performance of nursing care delivered and its impact on patient outcomes successfully using clinical nursing data from the study site. Although Nursing Practice and Research Information Management System was tested with small data sets, results of study revealed that it has the potential to measure nurses' delivery of care and its impact on patient outcomes, while pinpointing components of nursing process in need of improvement.

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID-TIA): study protocol for a pilot randomised controlled trial.

PubMed

Edwards, Duncan; Fletcher, Kate; Deller, Rachel; McManus, Richard; Lasserson, Daniel; Giles, Matthew; Sims, Don; Norrie, John; McGuire, Graham; Cohn, Simon; Whittle, Fiona; Hobbs, Vikki; Weir, Christopher; Mant, Jonathan

2013-07-02

People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist--that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. ISRCTN62019087.

Satanism among Adolescents: Empirical and Clinical Considerations.

ERIC Educational Resources Information Center

Steck, Gary M.; And Others

1992-01-01

Reviews literature on adolescent involvement in satanism. Presents results from a pilot study along with a case study to illustrate factors that may alert practitioners to adolescents who are susceptible to satanic influences. Discusses interventions for dealing with this adolescent subpopulation. (Author/NB)

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

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...

Human Papillomavirus-mediated cervical cancer awareness and Gardasil vaccination: a pilot survey among North Indian women.

PubMed

Pandey, Saumya; Chandravati

2013-10-01

Human Papillomavirus (HPV)-mediated cervical cancer is a leading cause of morbidity and mortality in women worldwide, including Indian women. Cervical cancer control and prevention strategies are being adopted in developing nations to reduce the increasing burden of HPV infection in the vaccine era. The present study, therefore, aimed to evaluate cervical cancer awareness and knowledge of Gardasil vaccination in North Indian women. A pilot survey was conducted among 103 women of North Indian ethnicity residing in Lucknow/adjoining areas in state of Uttar Pradesh, during routine screening/clinic visits from June 2012 to December 2012. The study subjects were interviewed in either Hindi or English; subsequently the awareness of HPV-mediated cervical cancer and knowledge of Gardasil vaccination was assessed in terms of "yes", "no" and "no response". The study was approved by the Institutional Review Board. Written informed consent was taken from the participants. Overall, the response of participants (n = 103) in our single-centre survey-based pilot study was well-defined. The response regarding HPV-mediated cervical cancer awareness in terms of "yes", "no" and "no response" among the study subjects was 43.7, 44.7 and 11.6 %, respectively. Furthermore, in response to knowledge of HPV vaccine Gardasil, out of 103 subjects, 28.1 % answered "yes" while 37.9 and 34.0 % stated "no" and "no response", respectively. Our pilot survey may help in assessing knowledge of HPV-mediated cervical cancer and Gardasil vaccination awareness in women, and accordingly develop cost-effective cervical cancer control and prevention/public health counseling sessions in a clinical setting.

An approach to improve the care of mid-life women through the implementation of a Women’s Health Assessment Tool/Clinical Decision Support toolkit

PubMed Central

Silvestrin, Terry M; Steenrod, Anna W; Coyne, Karin S; Gross, David E; Esinduy, Canan B; Kodsi, Angela B; Slifka, Gayle J; Abraham, Lucy; Araiza, Anna L; Bushmakin, Andrew G; Luo, Xuemei

2016-01-01

The objectives of this study are to describe the implementation process of the Women’s Health Assessment Tool/Clinical Decision Support toolkit and summarize patients’ and clinicians’ perceptions of the toolkit. The Women’s Health Assessment Tool/Clinical Decision Support toolkit was piloted at three clinical sites over a 4-month period in Washington State to evaluate health outcomes among mid-life women. The implementation involved a multistep process and engagement of multiple stakeholders over 18 months. Two-thirds of patients (n = 76/110) and clinicians (n = 8/12) participating in pilot completed feedback surveys; five clinicians participated in qualitative interviews. Most patients felt more prepared for their annual visit (69.7%) and that quality of care improved (68.4%) while clinicians reported streamlined patient visits and improved communication with patients. The Women’s Health Assessment Tool/Clinical Decision Support toolkit offers a unique approach to introduce and address some of the key health issues that affect mid-life women. PMID:27558508

Utilization of Portable Radios to Improve Ophthalmology Clinic Efficiency in an Academic Setting.

PubMed

Davis, Alexander S; Elkeeb, Ahmed M; Vizzeri, Gianmarco; Godley, Bernard F

2016-03-01

Improvement in clinic efficiency in the ambulatory setting is often looked at as an area for development of lean management strategies to deliver a higher quality of healthcare while reducing errors, costs, and delays. To examine the benefits of improving team communication and its impact on clinic flow and efficiency, we describe a time-motion study performed in an academic outpatient Ophthalmology clinic and its objective and subjective results. Compared to clinic encounters without the use of the portable radios, objective data demonstrated an overall significant decreases in mean workup time (15.18 vs. 13.10), room wait (13.10 vs. 10.47), and decreased the total time needed with an MD per encounter (9.45 vs. 6.63). Subjectively, significant improvements were seen in careprovider scores for patient flow (60.78 vs. 84.29), getting assistance (61.89 vs. 88.57), moving patient charts (54.44 vs. 85.71), teamwork (69.56 vs. 91.0), communications (62.33 vs. 90.43), providing quality patient care (76.22 vs. 89.57), and receiving input on the ability to see walk-in patients (80.11 vs. 90.43). For academic purposes, an improvement in engagement in patient care and learning opportunities was noted by the clinic resident-in-training during the pilot study. Portable radios in our pilot study were preferred over the previous method of communication and demonstrates significant improvements in certain areas of clinical efficiency, subjective perception of teamwork and communications, and academic learning.

Piloting a Deceased Subject Integrated Data Repository and Protecting Privacy of Relatives

PubMed Central

Huser, Vojtech; Kayaalp, Mehmet; Dodd, Zeyno A.; Cimino, James J.

2014-01-01

Use of deceased subject Electronic Health Records can be an important piloting platform for informatics or biomedical research. Existing legal framework allows such research under less strict de-identification criteria; however, privacy of non-decedent must be protected. We report on creation of the decease subject Integrated Data Repository (dsIDR) at National Institutes of Health, Clinical Center and a pilot methodology to remove secondary protected health information or identifiable information (secondary PxI; information about persons other than the primary patient). We characterize available structured coded data in dsIDR and report the estimated frequencies of secondary PxI, ranging from 12.9% (sensitive token presence) to 1.1% (using stricter criteria). Federating decedent EHR data from multiple institutions can address sample size limitations and our pilot study provides lessons learned and methodology that can be adopted by other institutions. PMID:25954378

Piloting a deceased subject integrated data repository and protecting privacy of relatives.

PubMed

Huser, Vojtech; Kayaalp, Mehmet; Dodd, Zeyno A; Cimino, James J

2014-01-01

Use of deceased subject Electronic Health Records can be an important piloting platform for informatics or biomedical research. Existing legal framework allows such research under less strict de-identification criteria; however, privacy of non-decedent must be protected. We report on creation of the decease subject Integrated Data Repository (dsIDR) at National Institutes of Health, Clinical Center and a pilot methodology to remove secondary protected health information or identifiable information (secondary PxI; information about persons other than the primary patient). We characterize available structured coded data in dsIDR and report the estimated frequencies of secondary PxI, ranging from 12.9% (sensitive token presence) to 1.1% (using stricter criteria). Federating decedent EHR data from multiple institutions can address sample size limitations and our pilot study provides lessons learned and methodology that can be adopted by other institutions.

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study.

PubMed

Cudia, Paola; Weis, Luca; Baba, Alfonc; Kiper, Pawel; Marcante, Andrea; Rossi, Simonetta; Angelini, Corrado; Piccione, Francesco

2016-11-01

Functional electrical stimulation (FES) is a new rehabilitative approach that combines electrical stimulation with a functional task. This pilot study evaluated the safety and effectiveness of FES lower extremity training in myotonic dystrophy type 1. This is a controlled pilot study that enrolled 20 patients with myotonic dystrophy type 1 over 2 years. Eight patients (age, 39-67 years) fulfilled the inclusion criteria. Four participants performed FES cycling training for 15 days (one daily session of 30 minutes for 5 days a week). A control group, matched for clinical and genetic variables, who had contraindications to electrical stimulation, performed 6 weeks of conventional resistance and aerobic training. The modified Medical Research Council Scale and functional assessments were performed before and after treatment. Cohen d effect size was used for statistical analysis. Functional electrical stimulation induced lower extremity training was well tolerated and resulted in a greater improvement of tibialis anterior muscle strength (d = 1,583), overall muscle strength (d = 1,723), and endurance (d = 0,626) than conventional training. Functional electrical stimulation might be considered a safe and valid tool to improve muscle function, also in muscles severely compromised in which no other restorative options are available. Confirmation of FES efficacy through further clinical trials is strongly advised.

Description and pilot results from a novel method for evaluating return of incidental findings from next-generation sequencing technologies.

PubMed

Goddard, Katrina A B; Whitlock, Evelyn P; Berg, Jonathan S; Williams, Marc S; Webber, Elizabeth M; Webster, Jennifer A; Lin, Jennifer S; Schrader, Kasmintan A; Campos-Outcalt, Doug; Offit, Kenneth; Feigelson, Heather Spencer; Hollombe, Celine

2013-09-01

The aim of this study was to develop, operationalize, and pilot test a transparent, reproducible, and evidence-informed method to determine when to report incidental findings from next-generation sequencing technologies. Using evidence-based principles, we proposed a three-stage process. Stage I "rules out" incidental findings below a minimal threshold of evidence and is evaluated using inter-rater agreement and comparison with an expert-based approach. Stage II documents criteria for clinical actionability using a standardized approach to allow experts to consistently consider and recommend whether results should be routinely reported (stage III). We used expert opinion to determine the face validity of stages II and III using three case studies. We evaluated the time and effort for stages I and II. For stage I, we assessed 99 conditions and found high inter-rater agreement (89%), and strong agreement with a separate expert-based method. Case studies for familial adenomatous polyposis, hereditary hemochromatosis, and α1-antitrypsin deficiency were all recommended for routine reporting as incidental findings. The method requires <3 days per topic. We establish an operational definition of clinically actionable incidental findings and provide documentation and pilot testing of a feasible method that is scalable to the whole genome.

Child Directed Interaction Training for Young Children in Kinship Care: A Pilot Study

PubMed Central

N’zi, Amanda M.; Stevens, Monica L.; Eyberg, Sheila M.

2016-01-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. PMID:27012997

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.

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

Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial.

PubMed

Koutoukidis, Dimitrios A; Beeken, Rebecca J; Manchanda, Ranjit; Burnell, Matthew; Knobf, M Tish; Lanceley, Anne

2016-03-10

Endometrial cancer survivors comprise a high-risk group for obesity-related comorbidities. Healthy eating and physical activity can lead to better health and well-being, but this population may experience difficulties adopting healthy lifestyle practices. Personalised behaviour change programmes that are feasible, acceptable and cost-effective are needed. The aim of this trial is to pilot a manualised programme about healthy eating and physical activity. This is a phase II, individually randomized, parallel, controlled, two-site, pilot clinical trial. Adult endometrial cancer survivors (n = 64) who have been diagnosed with endometrial cancer within the previous 3 years and are not on active treatment will be invited to participate. Participants will be assigned in a 1:1 ratio through minimisation to either an 8-week, group-based, behaviour-change programme with weekly 90-min sessions about healthy eating and physical activity or usual care. The intervention will focus on self-monitoring, goal setting and self-rewards. Follow-up assessments will be conducted at 8 and 24 weeks from the baseline assessment. Primary feasibility outcomes will include rates of recruitment, adherence, and retention. The study results will inform the development of a definitive randomised controlled trial to test if the programme can improve the health and quality of life of this population. It will also provide guidance on costing the intervention and the health care resource use in this population. ClinicalTrials.gov identifier: NCT02433080, 20 April 2015.

Physicians' accounts of frontline tensions when implementing pilot projects to improve primary care.

PubMed

Mansfield, Elizabeth; Bhattacharyya, Onil; Christian, Jennifer; Naglie, Gary; Steriopoulos, Vicky; Webster, Fiona

2018-03-19

Purpose Canada's primary care system has been described as "a culture of pilot projects" with little evidence of converting successful initiatives into funded, permanent programs or sharing project outcomes and insights across jurisdictions. Health services pilot projects are advocated as an effective strategy for identifying promising models of care and building integrated care partnerships in local settings. In the qualitative study reported here, the purpose of this paper is to investigate the strengths and challenges of this approach. Design/methodology/approach Semi-structured interviews were conducted with 34 primary care physicians who discussed their experiences as pilot project leads. Following thematic analysis methods, broad system issues were captured as well as individual project information. Findings While participants often portrayed themselves as advocates for vulnerable patients, mobilizing healthcare organizations and providers to support new models of care was discussed as challenging. Competition between local healthcare providers and initiatives could impact pilot project success. Participants also reported tensions between their clinical, project management and research roles with additional time demands and skill requirements interfering with the work of implementing and evaluating service innovations. Originality/value Study findings highlight the complexity of pilot project implementation, which encompasses physician commitment to addressing care for vulnerable populations through to the need for additional skill set requirements and the impact of local project environments. The current pilot project approach could be strengthened by including more multidisciplinary collaboration and providing infrastructure supports to enhance the design, implementation and evaluation of health services improvement initiatives.

Satanism among adolescents: empirical and clinical considerations.

PubMed

Steck, G M; Anderson, S A; Boylin, W M

1992-01-01

This paper reviews the literature on adolescent involvement in satanism. Results from a pilot study are presented along with a case study to illustrate factors that may alert practitioners to adolescents who are susceptible to satanic influences. Interventions for dealing with this adolescent subpopulation are discussed.

The UAE healthy future study: a pilot for a prospective cohort study of 20,000 United Arab Emirates nationals.

PubMed

Abdulle, Abdishakur; Alnaeemi, Abdullah; Aljunaibi, Abdullah; Al Ali, Abdulrahman; Al Saedi, Khaled; Al Zaabi, Eiman; Oumeziane, Naima; Al Bastaki, Marina; Al-Houqani, Mohammed; Al Maskari, Fatma; Al Dhaheri, Ayesha; Shah, Syed M; Loney, Tom; El-Sadig, Mohamed; Oulhaj, Abderrahim; Wareth, Leila Abdel; Al Mahmeed, Wael; Alsafar, Habiba; Hirsch, Benjamin; Al Anouti, Fatme; Yaaqoub, Jamila; Inman, Claire K; Al Hamiz, Aisha; Al Hosani, Ayesha; Haji, Muna; Alsharid, Teeb; Al Zaabi, Thekra; Al Maisary, Fatima; Galani, Divya; Sprosen, Tim; El Shahawy, Omar; Ahn, Jiyoung; Kirchhoff, Tomas; Ramasamy, Ravichandran; Schmidt, Ann Marie; Hayes, Richard; Sherman, Scott; Ali, Raghib

2018-01-05

The United Arab Emirates (UAE) is faced with a rapidly increasing burden of non-communicable diseases including obesity, diabetes, and cardiovascular disease. The UAE Healthy Future study is a prospective cohort designed to identify associations between risk factors and these diseases amongst Emiratis. The study will enroll 20,000 UAE nationals aged ≥18 years. Environmental and genetic risk factors will be characterized and participants will be followed for future disease events. As this was the first time a prospective cohort study was being planned in the UAE, a pilot study was conducted in 2015 with the primary aim of establishing the feasibility of conducting the study. Other objectives were to evaluate the implementation of the main study protocols, and to build adequate capacity to conduct advanced clinical laboratory analyses. Seven hundred sixty nine UAE nationals aged ≥18 years were invited to participate voluntarily in the pilot study. Participants signed an informed consent, completed a detailed questionnaire, provided random blood, urine, and mouthwash samples and were assessed for a series of clinical measures. All specimens were transported to the New York University Abu Dhabi laboratories where samples were processed and analyzed for routine chemistry and hematology. Plasma, serum, and a small whole blood sample for DNA extraction were aliquoted and stored at -80 °C for future analyses. Overall, 517 Emirati men and women agreed to participate (68% response rate). Of the total participants, 495 (95.0%), 430 (82.2%), and 492 (94.4%), completed the questionnaire, physical measurements, and provided biological samples, respectively. The pilot study demonstrated the feasibility of recruitment and completion of the study protocols for the first large-scale cohort study designed to identify emerging risk factors for the major non-communicable diseases in the region.

Exploring the role of children's dreams in psychoanalytic practice today: a pilot study.

PubMed

Lempen, Olivia; Midgley, Nick

2006-01-01

The aim of this research study was to investigate the role of children's dreams in the practice of child psychoanalysis today, and to explore contemporary psychoanalytic understanding of children's dreams. This pilot study consisted of two stages. The first involved a document analysis of published articles in The Psychoanalytic Study of the Child, making a comparison between those of the early 1950s and the 1990s, in order to see in what way the discourse around children's dreams within the psychoanalytic literature has changed over time. The second stage, based on questionnaires and in-depth interviews, attempted to understand in more detail the way contemporary child analysts, working in the Anna Freudian tradition, think about dreams and use them in their clinical practice. Results suggest that there has been a decreased focus on dreams in a clinical context over time, and that this may partly be a consequence of changing theoretical models and changes in training. When work with dreams does take place, it appears that child analysts have

Cost-effectiveness of midwifery services vs. medical services in Quebec. LEquipe dEvaluation des Projets-Pilotes Sages-Femmes.

PubMed

Reinharz, D; Blais, R; Fraser, W D; Contandriopoulos, A P

2000-01-01

This study compared the cost-effectiveness of midwife services provided in birth centres operating as pilot projects with current hospital-based medical services in the province of Quebec. One thousand midwives' clients were matched with 1,000 physicians' clients on the basis of socio-demographic characteristics and obstetrical risk. Direct costs for the prenatal, intrapartum and postpartum periods were estimated. Effectiveness was assessed on the basis of three clinical indicators and four indices related to the individualization of care as assessed by women. Results show that the costs of midwife services were barely lower than or equal to those of physician services, but cost-effectiveness ratios were to the advantage of the midwife group, except for one clinical indicator (neonatal ventilation). Overall, this study provides rational support for the process of legalizing midwifery in the province.

Effects of dental magnification lenses on indirect vision: a pilot study.

PubMed

Hoerler, Sarah B; Branson, Bonnie G; High, Anne M; Mitchell, Tanya Villalpando

2012-01-01

The purpose of this pilot study was to evaluate the effect of magnification lenses on the indirect vision skills of dental hygiene students. This pilot study examined the accuracy and efficiency of dental hygiene students' indirect vision skills while using traditional safety lenses and magnification lenses. The sample was comprised of 14 students in their final semester of a dental hygiene program. A crossover study approach was utilized, with each participant randomly assigned to a specific order of eyewear. The study included evaluation of each participant taking part in 2 separate clinical sessions. During the first session, each participant completed a clinical exercise on a dental manikin marked with 15 dots throughout the oral cavity while wearing the randomly as signed eyewear, and then completed a similar exercise on a differently marked dental manikin while wearing the randomly assigned eyewear. This procedure was repeated at a second clinical session, however, the dental manikin and eyewear pairings were reversed. Accuracy was measured on the number of correctly identified dots and efficiency was measured by the time it took to identify the dots. Perceptions of the participants' use of magnification lenses and the participants' opinion of the use of magnification lenses in a dental hygiene curriculum were evaluated using a questionnaire. Comparing the mean of the efficiency scores, students are more efficient at identifying indirect vision points with the use of magnification lenses (3 minutes, 36 seconds) than with traditional safety lenses (3 minutes, 56 seconds). Comparing the measurement of accuracy, students are more accurate at identifying indirect vision points with traditional safety lenses (84%) as com pared to magnification lenses (79%). Overall, the students report ed an increased quality of dental hygiene treatment provided in the clinical setting and an improved clinical posture while treating patients with the use of magnification lenses. This study did not produce statistically significant data to support the use of magnification lenses to enhance indirect vision skills among dental hygiene students, however, students perceived that their indirect vision skills were enhanced by the use of magnification lenses.

Application of Human Augmentics: A Persuasive Asthma Inhaler.

PubMed

Grossman, Brent; Conner, Steve; Mosnaim, Giselle; Albers, Joshua; Leigh, Jason; Jones, Steve; Kenyon, Robert

2017-03-01

This article describes a tailored health intervention delivered on a mobile phone platform, integrating low-literacy design strategies and basic principles of behavior change, to promote increased adherence and asthma control among underserved minority adolescents. We based the intervention and design principles on theories of Human Augmentics and the Elaboration Likelihood Model. We tested the efficacy of using electronic monitoring devices that incorporate informative and persuasive elements to improve adherence to a prescribed daily medication regimen intended to reduce use of asthma rescue medications. We describe the theoretical framework, hardware and software systems, and results of user testing for design purposes and a clinical pilot study incorporating use of the device and software by the targeted population. The results of the clinical pilot study showed an 83% completion rate for the treatment as well as improved adherence. Of note, 8% and 58% of participants achieved clinically significant adherence targets at baseline and last week of the study, respectively. Rescue asthma medication use decreased from a median of 3 puffs per week at baseline to 0 puffs per week during the last week of the study. Copyright © 2017 Elsevier Inc. All rights reserved.

Electronic Assessment and Feedback Tool in Supervision of Nursing Students during Clinical Training

ERIC Educational Resources Information Center

Mettiäinen, Sari

2015-01-01

The aim of this study was to determine nursing teachers' and students' attitudes to and experiences of using an electronic assessment and feedback tool in supervision of clinical training. The tool was called eTaitava, and it was developed in Finland. During the pilot project, the software was used by 12 nursing teachers and 430 nursing students.…

Promoting quality and safety in women's health through the use of transdisciplinary clinical simulation educational modules: methodology and a pilot trial.

PubMed

Montgomery, Kymberlee; Morse, Catherine; Smith-Glasgow, Mary Ellen; Posmontier, Bobbie; Follen, Michele

2012-02-01

This manuscript presents the methodology used to assess the impact of a clinical simulation module used for training providers specializing in women's health. The methodology presented here will be used for a quantitative study in the future. Copyright © 2012 Elsevier HS Journals, Inc. All rights reserved.

Using a didactic model to improve patient observation skills in neonatal intensive care nurse trainees - a pilot study.

PubMed

Solberg, Marianne Trygg; Tandberg, Bente Silnes; Lerdal, Anners

2012-08-01

To implement a didactic model for students specialising in intensive care nursing (n=12) and nurses working in neonatal intensive care units (NICU) (n=17). To evaluate nurse self-assessments following observation of children with congenital heart disease (CHD), before and after participation in the programme, as well as the usefulness of the programme. A pilot study with a pre- and post-test design, using self-administered questionnaires. The didactic model increased the number of clinical observations and assessments of physiological factors made by both students and NICU nurses during evaluation of children with suspected CHD. The majority of nurses reported that both participation in the programme and the didactic model were useful and they demonstrated high-level knowledge, according to Bloom's taxonomy for cognitive learning. In particular, subjects found that the literature provided and structured bedside guidance in the clinical setting assisted learning. Intensive care students and NICU nurses performed clinical observations and physical factor assessments more frequently after completing the programme, compared with baseline. We speculate that this didactic model may also be useful in other clinical settings. Copyright © 2011 Elsevier Ltd. All rights reserved.

Visual health screening by schoolteachers in remote communities of Peru: implementation research

PubMed Central

Latorre-Arteaga, Sergio; Gil-González, Diana; Bascarán, Covadonga; Núñez, Richard Hurtado; Morales, María del Carmen Peral; Orihuela, Guillermo Carrillo

2016-01-01

Abstract Objective To describe the adaptation and scaling-up of an intervention to improve the visual health of children in the Apurimac region, Peru. Methods In a pilot screening programme in 2009–2010, 26 schoolteachers were trained to detect and refer visual acuity problems in schoolchildren in one district in Apurimac. To scale-up the intervention, lessons learnt from the pilot were used to design strategies for: (i) strengthening multisector partnerships; (ii) promoting the engagement and participation of teachers and (iii) increasing children’s attendance at referral eye clinics. Implementation began in February 2015 in two out of eight provinces of Apurimac, including hard-to-reach communities. We made an observational study of the processes and outcomes of adapting and scaling-up the intervention. Qualitative and quantitative analyses were made of data collected from March 2015 to January 2016 from programme documents, routine reports and structured evaluation questionnaires completed by teachers. Findings Partnerships were expanded after sharing the results of the pilot phase. Training was completed by 355 teachers and directors in both provinces, belonging to 315 schools distributed in 24 districts. Teachers’ appraisal of the training achieved high positive scores. Outreach eye clinics and subsidies for glasses were provided for poorer families. Data from six districts showed that attendance at the eye clinic increased from 66% (45/68 children referred) in the pilot phase to 92% (237/259) in the implementation phase. Conclusion Adaptation to the local context allowed the scaling-up of an intervention to improve visual health in children and enhanced the equity of the programme. PMID:27708470

Anterior Segment Optical Coherence Tomography Angiography for Identification of Iris Vasculature and Staging of Iris Neovascularization: A Pilot Study.

PubMed

Roberts, Philipp K; Goldstein, Debra A; Fawzi, Amani A

2017-08-01

Purpose/Aim of the study: To assess the ability of optical coherence tomographic angiography (OCTA) to visualize the normal iris vasculature as well as neovascularization of the iris (NVI). Study participants with healthy eyes, patients at risk of NVI development and patients with active or regressed NVI were consecutively included in this cross-sectional observational study. Imaging was performed using a commercially available OCTA system (RTVue- XR Avanti, Optovue Inc., Fremont, CA, USA). Abnormal iris vessels were graded on OCTA according to a modified clinical staging system and compared to slitlamp and gonioscopic findings. Fifty eyes of 26 study participants (16 healthy eyes, 19 eyes at risk, 15 eyes with different stages of NVI) were imaged using OCTA. In 11 out of 16 healthy eyes (69%) with light or moderately dark iris pigmentation, we observed physiological, radially aligned iris vasculature on OCTA imaging, which could not be visualized in five eyes (31%) with darkly pigmented irides. One eye in the "eyes at risk" group was diagnosed with NVI based on OCTA, which was not observed clinically. Fifteen eyes with clinically active or regressed NVI were imaged. Different stages of NVI could be differentiated by OCTA, corresponding well to an established clinical grading system. Four eyes showed regressed NVI by OCTA, not seen clinically, and were graded as a newly defined stage 4. This pilot clinical study showed that OCTA for imaging of the iris vasculature in health and disease is highly dependent on iris pigmentation. Fine, clinically invisible iris vessels can be visualized by OCTA in the very early stages as well as in the regressed stage of NVI.

Anterior Segment Optical Coherence Tomography Angiography for Identification of Iris Vasculature and Staging of Iris Neovascularization: A Pilot Study

PubMed Central

Roberts, Philipp K.; Goldstein, Debra A.; Fawzi, Amani A.

2017-01-01

Purpose/Aim of the study To assess the ability of optical coherence tomographic angiography (OCTA) to visualize the normal iris vasculature as well as neovascularization of the iris (NVI). Materials and Methods Study participants with healthy eyes, patients at risk of NVI development and patients with active or regressed NVI were consecutively included in this cross-sectional observational study. Imaging was performed using a commercially available OCTA system (RTVue- XR Avanti, Optovue Inc., Fremont, CA, USA). Abnormal iris vessels were graded on OCTA according to a modified clinical staging system and compared to slitlamp and gonioscopic findings. Results Fifty eyes of 26 study participants (16 healthy eyes, 19 eyes at risk, 15 eyes with different stages of NVI) were imaged using OCTA. In 11 out of 16 healthy eyes (69%) with light or moderately dark iris pigmentation, we observed physiological, radially aligned iris vasculature on OCTA imaging, which could not be visualized in five eyes (31%) with darkly pigmented irides. One eye in the “eyes at risk” group was diagnosed with NVI based on OCTA, which was not observed clinically. Fifteen eyes with clinically active or regressed NVI were imaged. Different stages of NVI could be differentiated by OCTA, corresponding well to an established clinical grading system. Four eyes showed regressed NVI by OCTA, not seen clinically, and were graded as a newly defined stage 4. Conclusions This pilot clinical study showed that OCTA for imaging of the iris vasculature in health and disease is highly dependent on iris pigmentation. Fine, clinically invisible iris vessels can be visualized by OCTA in the very early stages as well as in the regressed stage of NVI. PMID:28441067

Pilot study of enhanced tobacco-cessation services coverage for low-income smokers.

PubMed

Doescher, Mark P; Whinston, Melicent A; Goo, Alvin; Cummings, Diane; Huntington, Jane; Saver, Barry G

2002-01-01

This study explored the feasibility of covering nicotine replacement therapy (NRT) and paying for pharmacist-delivered smoking cessation counseling at the time of NRT pick-up for low-income, managed Medicaid and Basic Health Plan (a state insurance program) enrollees. A prospective pilot intervention was used at two community health centers (CHCs) and two community pharmacies. Participants were adult managed-Medicaid or Basic Health Plan enrollees who attended the pilot CHCs and smoked. An innovative insurance benefit that included coverage for NRT and $15 payment to the pharmacist to deliver cessation counseling with each prescription fill. Proportion of eligible patients who used the cessation benefit and patient and pharmacist satisfaction with the intervention. During the 9-month intervention, 32 patients at the pilot clinics were referred for NRT and pharmacist-delivered counseling. This number represented roughly 5% of eligible smokers. Of these, 26 received NRT with concomitant pharmacist-delivered cessation counseling at least once. Recipients reported a high level of satisfaction with this intervention. Pharmacists indicated they would continue providing counseling if reimbursement remained adequate and if counseling lasted no longer than 5-10 min. However, 12 (38%) who were referred were no longer insured by the sponsoring plan by the end of the 9-month pilot period. Pharmacist-delivered cessation counseling may be feasible and merits further study. More importantly, this pilot reveals two key obstacles in our low-income, culturally diverse setting: low participation and rapid turnover of insureds. Future interventions will need to address these barriers.

Organizational characteristics of HIV/syphilis testing services for men who have sex with men in South China: a social entrepreneurship analysis and implications for creating sustainable service models.

PubMed

Tucker, Joseph D; Muessig, Kathryn E; Cui, Rosa; Bien, Cedric H; Lo, Elaine J; Lee, Ramon; Wang, Kaidi; Han, Larry; Liu, Feng-Ying; Yang, Li-Gang; Yang, Bin; Larson, Heidi; Peeling, Rosanna W

2014-11-25

UNAIDS has called for greater HIV/syphilis testing worldwide just as local HIV/syphilis testing programs are cut or altered. New models are needed to make HIV/syphilis testing services sustainable while retaining their essential public health function. Social entrepreneurship, using business principles to promote a social cause, provides a framework to pilot programs that sustainably expand testing. Drawing on fieldwork in two South Chinese cities, we examined organizational and financial characteristics of current HIV/syphilis testing systems for men who have sex with men (MSM) in addition to new pilot programs focused on revenue-generation for sustainability. We undertook a qualitative study to explore organizational and financial characteristics of HIV/syphilis testing for MSM. Data were collected from men who have sex with men and policy stakeholders in Guangzhou and Hong Kong. Framework analysis was used to identify themes and then code the data. Our qualitative research study included MSM and policy stakeholders (n = 84). HIV/syphilis testing services were implemented at a wide range of organizations which we grouped broadly as independent community-based organizations (CBOs), independent clinics, and hybrid CBO-clinic sites. From an organizational perspective, hybrid CBO-clinic sites offered the inclusive environment of an MSM CBO linked to the technical capacity and trained staff of a clinic. From a financial perspective, stakeholders expressed concern about the sustainability and effectiveness of sexual health services reliant on external funding. We identified four hybrid CBO-clinic organizations that launched pilot testing programs in order to generate revenue while expanding HIV testing. Many MSM CBOs are searching for new organizational models to account for decreased external support. Hybrid CBO-clinic organizations create a strong foundation to increase HIV/syphilis testing using social entrepreneurship models in China.

Impact of Atraumatic Restorative Treatment (ART) on the treatment profile in pilot government dental clinics in Tanzania.

PubMed

Kikwilu, Emil Namakuka; Frencken, Jo; Mulder, Jan

2009-06-08

The predominant mode of treatment in government dental clinics in Tanzania has been tooth extraction because the economy could not support the conventional restorative care which depends on expensive equipment, electricity and piped water systems. Atraumatic Restorative Treatment (ART) was perceived as a suitable alternative. A 3.5-year study was designed to document the changes in the treatment profiles ascribed to the systematic introduction of ART in pilot government dental clinics. Dental practitioners who were working in 13 government dental clinics underwent a 7-day ART training. Treatment record data on teeth extracted and teeth restored by the conventional and ART approaches were collected from these clinics for the three study periods. The mean percentage of ART restorations to total treatment, ART restorations to total restorations, and total restorations to total treatments rendered were computed. Differences between variables were determined by ANOVA, t-test and Chi-square. The mean percentage of ART restorations to total treatment rendered was 0.4 (SE = 0.5) and 11.9 (SE = 1.1) during the baseline and second follow-up period respectively (ANOVA mixed model; P < 0.0001). The mean percentage of ART restorations to total restorations rendered at baseline and 2nd follow-up period was 8.4% and 88.9% respectively (ANOVA mixed model; P < 0.0001). The mean percentage of restorations to total treatment rendered at baseline and 2nd follow-up was 3.9% and 13.0%, respectively (ANOVA mixed model; P < 0.0001). Ninety-nine percent of patients were satisfied with ART restorations, 96.6% willing to receive ART restoration again in future, and 94.9% willing to recommend ART treatment to their close relatives. ART introduction in pilot government dental clinics raised the number of teeth saved by restorative care. Countrywide introduction of the ART approach in Tanzania is recommended.

Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

PubMed

Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

2014-12-23

The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. ChiCTR-TRC-13003911. 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.

A comparison of two recorders for obtaining in-flight heart rate data.

PubMed

Dahlstrom, Nicklas; Nahlinder, Staffan

2006-09-01

: Measurement of mental workload has been widely used for evaluation of aircraft design, mission analysis and assessment of pilot performance during flight operations. Heart rate is the psychophysiological measure that has been most frequently used for this purpose. The risk of interference with flight safety and pilot performance, as well as the generally constrained access to flights, make it difficult for researchers to collect in-flight heart rate data. Thus, this study was carried out to investigate whether small, non-intrusive sports recorders can be used for in-flight data collection for research purposes. Data was collected from real and simulated flights with student pilots using the Polar Team System sports recorder and the Vitaport II, a clinical and research recording device. Comparison of the data shows that in-flight heart rate data from the smaller and less intrusive sports recorder have a correlation of.981 with that from the clinical recorder, thus indicating that the sports recorder is reliable and cost-effective for obtaining heart rate data for many research situations.

Embedding evidence-based practice among nursing undergraduates: Results from a pilot study.

PubMed

André, Beate; Aune, Anne G; Brænd, Jorunn A

2016-05-01

Evidence-based practice is currently one of the most important developments in health care. Research in nursing science is rapidly growing; however, translating the knowledge based on this research into clinical practice is often hampered, and may be dependent on reflective skills. The aim of this study was to see how undergraduate nursing students in nursing should increase their skills and knowledge related to evidence-based practice through participation in clinical research projects. A qualitative approach was used in collecting and analyzing the data. Students participated in a pilot clinical research project and a received guidance related to their bachelor thesis. After the project was completed, all students filled in a questionnaire. The students' motivation to participate in this study was reported to be high, but they reported low knowledge related to evidence-based practice. All students reported that their attitude towards evidence-based practice changed in a positive direction during their participation in the project. Evidence-based practice influenced nursing practices by putting more focus on critical thinking, increasing pride and giving a sense of ownership in the clinical field. The curricula and the pedagogical perspectives in nursing education can influence the attitude towards evidence-based practice and skills among nursing bachelor students. Copyright © 2016 Elsevier Ltd. All rights reserved.

Assessment of personality-related levels of functioning: a pilot study of clinical assessment of the DSM-5 level of personality functioning based on a semi-structured interview.

PubMed

Thylstrup, Birgitte; Simonsen, Sebastian; Nemery, Caroline; Simonsen, Erik; Noll, Jane Fjernestad; Myatt, Mikkel Wanting; Hesse, Morten

2016-08-25

The personality disorder categories in the Diagnostic and Statistical Manual of Mental Disorders IV have been extensively criticized, and there is a growing consensus that personality pathology should be represented dimensionally rather than categorically. The aim of this pilot study was to test the Clinical Assessment of the Level of Personality Functioning Scale, a semi-structured clinical interview, designed to assess the Level of Personality Functioning Scale of the DSM-5 (Section III) by applying strategies similar to what characterizes assessments in clinical practice. The inter-rater reliability of the assessment of the four domains and the total impairment in the Level of Personality Functioning Scale were measured in a patient sample that varied in terms of severity and type of pathology. Ratings were done independently by the interviewer and two experts who watched a videotaped Clinical Assessment of the Level of Personality Functioning Scale interview. Inter-rater reliability coefficients varied between domains and were not sufficient for clinical practice, but may support the use of the interview to assess the dimensions of personality functioning for research purposes. While designed to measure the Level of Personality Functioning Scale with a high degree of similarity to clinical practice, the Clinical Assessment of the Level of Personality Functioning Scale had weak reliabilities and a rating based on a single interview should not be considered a stand-alone assessment of areas of functioning for a given patient.

Free and simple GIS as appropriate for health mapping in a low resource setting: a case study in eastern Indonesia.

PubMed

Fisher, Rohan P; Myers, Bronwyn A

2011-02-25

Despite the demonstrated utility of GIS for health applications, there are perceived problems in low resource settings: GIS software can be expensive and complex; input data are often of low quality. This study aimed to test the appropriateness of new, inexpensive and simple GIS tools in poorly resourced areas of a developing country. GIS applications were trialled in pilot studies based on mapping of health resources and health indicators at the clinic and district level in the predominantly rural province of Nusa Tenggara Timur in eastern Indonesia. The pilot applications were (i) rapid field collection of health infrastructure data using a GPS enabled PDA, (ii) mapping health indicator data using open source GIS software, and (iii) service availability mapping using a free modelling tool. Through contextualised training, district and clinic staff acquired skills in spatial analysis and visualisation and, six months after the pilot studies, they were using these skills for advocacy in the planning process, to inform the allocation of some health resources, and to evaluate some public health initiatives. We demonstrated that GIS can be a useful and inexpensive tool for the decentralisation of health data analysis to low resource settings through the use of free and simple software, locally relevant training materials and by providing data collection tools to ensure data reliability.

Free and simple GIS as appropriate for health mapping in a low resource setting: a case study in eastern Indonesia

PubMed Central

2011-01-01

Background Despite the demonstrated utility of GIS for health applications, there are perceived problems in low resource settings: GIS software can be expensive and complex; input data are often of low quality. This study aimed to test the appropriateness of new, inexpensive and simple GIS tools in poorly resourced areas of a developing country. GIS applications were trialled in pilot studies based on mapping of health resources and health indicators at the clinic and district level in the predominantly rural province of Nusa Tenggara Timur in eastern Indonesia. The pilot applications were (i) rapid field collection of health infrastructure data using a GPS enabled PDA, (ii) mapping health indicator data using open source GIS software, and (iii) service availability mapping using a free modelling tool. Results Through contextualised training, district and clinic staff acquired skills in spatial analysis and visualisation and, six months after the pilot studies, they were using these skills for advocacy in the planning process, to inform the allocation of some health resources, and to evaluate some public health initiatives. Conclusions We demonstrated that GIS can be a useful and inexpensive tool for the decentralisation of health data analysis to low resource settings through the use of free and simple software, locally relevant training materials and by providing data collection tools to ensure data reliability. PMID:21352553

Value of information analysis optimizing future trial design from a pilot study on catheter securement devices.

PubMed

Tuffaha, Haitham W; Reynolds, Heather; Gordon, Louisa G; Rickard, Claire M; Scuffham, Paul A

2014-12-01

Value of information analysis has been proposed as an alternative to the standard hypothesis testing approach, which is based on type I and type II errors, in determining sample sizes for randomized clinical trials. However, in addition to sample size calculation, value of information analysis can optimize other aspects of research design such as possible comparator arms and alternative follow-up times, by considering trial designs that maximize the expected net benefit of research, which is the difference between the expected cost of the trial and the expected value of additional information. To apply value of information methods to the results of a pilot study on catheter securement devices to determine the optimal design of a future larger clinical trial. An economic evaluation was performed using data from a multi-arm randomized controlled pilot study comparing the efficacy of four types of catheter securement devices: standard polyurethane, tissue adhesive, bordered polyurethane and sutureless securement device. Probabilistic Monte Carlo simulation was used to characterize uncertainty surrounding the study results and to calculate the expected value of additional information. To guide the optimal future trial design, the expected costs and benefits of the alternative trial designs were estimated and compared. Analysis of the value of further information indicated that a randomized controlled trial on catheter securement devices is potentially worthwhile. Among the possible designs for the future trial, a four-arm study with 220 patients/arm would provide the highest expected net benefit corresponding to 130% return-on-investment. The initially considered design of 388 patients/arm, based on hypothesis testing calculations, would provide lower net benefit with return-on-investment of 79%. Cost-effectiveness and value of information analyses were based on the data from a single pilot trial which might affect the accuracy of our uncertainty estimation. Another limitation was that different follow-up durations for the larger trial were not evaluated. The value of information approach allows efficient trial design by maximizing the expected net benefit of additional research. This approach should be considered early in the design of randomized clinical trials. © The Author(s) 2014.

Collaborative Audit of Risk Evaluation in Medical Emergency Treatment (CARE-MET I) - an international pilot.

PubMed

Subbe, C P; Gauntlett, W; Kellett, J G

2010-06-01

The absence of an accepted model for risk-adjustment of acute medical admissions leads to suboptimal clinical triage and serves as a disincentive to compare outcomes in different hospitals. The Simple Clinical Score (SCS) is a model based on 16 clinical parameters affecting hospital mortality. We undertook a feasibility pilot in 21 hospitals in Europe and New Zealand each collecting data for 12 or more consecutive medical emergency admissions. Data from 281 patients was analysed. Severity of illness as estimated by SCS was related to risk of admission to the Intensive Care Unit (p<0.001) but not to the Coronary Care Unit. Mortality increased from 0% in the Very Low Risk group to 22% in the Very High Risk Group (p<0.0001). Very low scores were associated with earlier discharge as opposed to very high scores (mean length of stay of 2.4 days vs 5.6 days, p<0.001). There were differences in the pattern of discharges in different hospitals with comparable SCS data. Clinicians reported no significant problems with the collection of data for the score in a number of different health care settings. The SCS appears to be a feasible tool to assist clinical triage of medical emergency admissions. The ability to view the profile of the SCS for different clinical centres opens up the possibility of accurate comparison of outcomes across clinical centres without distortion by different regional standards of health care. This pilot study demonstrates that the adoption of the SCS is practical across an international range of hospitals. Copyright 2010 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

Pilot clinical application of an adaptive robotic system for young children with autism

PubMed Central

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

2013-01-01

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 group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. PMID:24104517

Clinical Practice Improvement Approach in Multiple Sclerosis Rehabilitation: A Pilot Study

ERIC Educational Resources Information Center

Khan, Fary

2010-01-01

The objective of this study was to explore methods examining patient complexity and therapy interventions in relation to functional outcomes from an inpatient multiple sclerosis (MS) rehabilitation program. Retrospective and prospective data for 24 consecutive inpatients at a tertiary rehabilitation facility assessed (i)…

Electronic Health Records and Information Portability: A Pilot Study in a Rural Primary Healthcare Center in India

PubMed Central

Radhakrishna, Kedar; Goud, B. Ramakrishna; Kasthuri, Arvind; Waghmare, Abijeet; Raj, Tony

2014-01-01

Clinical documentation and health information portability pose unique challenges in urban and rural areas of India. This article presents findings of a pilot study conducted in a primary health center in rural India. In this article, we focus on primary care in rural India and how a portable health record system could facilitate the availability of medical information at the point of care. We followed a geriatric cohort and a maternal cohort of 308 participants over a nine-month period. Physician encounters were entered into a web-based electronic health record. This information was made available to all study participants through a short messaging service (SMS). Additionally, 135 randomly selected participants from the cohort were issued a USB-based memory card that contained their detailed health records and could be viewed on most computers. The dual portability model implemented in the pilot study demonstrates the utility of the concept. PMID:25214819

Evaluating the cost of one telehealth application connecting an acute and long-term care setting.

PubMed

Specht, J K; Wakefield, B; Flanagan, J

2001-01-01

This article describes a study of the costs of a pilot telemedicine chronic wound consultation clinic. Cost minimization analysis is the technique used to examine the costs of the clinic. The components of cost analysis include the fixed costs of personnel and equipment and the indirect costs of circuit and line charges. Cost avoidance is also examined. Cost avoidance evaluates what costs were avoided by the use of the telemedicine clinic. Additionally, the cost perspectives of the consulting agency, the referring agency, and the patient are examined. The average cost of a chronic wound consultation was $136.16 (acute care perspective). Costs of a traditional face-to-face consultation, if the residents were transported to the acute care facility would be $246.28. Fifteen telehealth consultations per month were used to determine per consultation costs for line charges and depreciation/maintenance costs. In this pilot study, a cost savings was realized and patients benefited. Increased volume will help to offset the cost of the equipment depreciation and maintenance and make telehealth chronic wound consultations more cost effective.

A pilot study on conducting mobile learning activities for clinical nursing courses based on the repertory grid approach.

PubMed

Wu, Po-Han; Hwang, Gwo-Jen; Tsai, Chin-Chung; Chen, Ya-Chun; Huang, Yueh-Min

2011-11-01

In clinical nursing courses, students are trained to identify the status of the target patients. The mastery of such ability and skills is very important since patients frequently need to be cared for immediately. In this pilot study, a repertory grid-oriented clinical mobile learning system is developed for a nursing training program. With the assistance of the mobile learning system, the nursing school students are able to learn in an authentic learning scenario, in which they can physically face the target patients, with the personal guidance and supplementary materials from the learning system to support them. To show the effectiveness of this innovative approach, an experiment has been conducted on the "respiratory system" unit of a nursing course. The experimental results show that the innovative approach is helpful to students in improving their learning achievements. Moreover, from the questionnaire surveys, it was found that most students showed favorable attitudes toward the usage of the mobile learning system and their participation in the training program. Copyright © 2010 Elsevier Ltd. All rights reserved.

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

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.

Pilot Research as Advocacy: The Case of Sayana Press in Kinshasa, Democratic Republic of the Congo

PubMed Central

Binanga, Arsene; Bertrand, Jane T

2016-01-01

ABSTRACT In the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to give injections, with one exception—medical and nursing students may also give injections if supervised by a clinical instructor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC to test the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the community level through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptive Depo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a short needle called the Uniject system. The Uniject system allows Sayana Press to be administered by community health workers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approval from the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward authorization for community health workers to provide the method. The pilot described in this article documents a process whereby an innovative approach moved from concept to implementation to replication in less than 2 years. It also paved the way for testing additional progressive strategies to increase access to contraception at the community level. Because the pilot project included a research component designed to assess benefits and challenges, it provided the means to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conference on family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketing authorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) conducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings to family planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was no precedent for medical and nursing students providing family planning methods or giving injections at the community level. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decision maker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of 3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection for Sayana Press with supervision by students, and injection of Sayana Press by community health workers with no formal clinical training. PMID:27979874

Pilot Research as Advocacy: The Case of Sayana Press in Kinshasa, Democratic Republic of the Congo.

PubMed

Binanga, Arsene; Bertrand, Jane T

2016-12-23

In the Democratic Republic of the Congo (DRC), the Ministry of Health authorizes only physicians and nurses to give injections, with one exception-medical and nursing students may also give injections if supervised by a clinical instructor. The emergence of the injectable contraceptive Sayana Press in some African countries prompted the DRC to test the acceptability and feasibility of distributing Sayana Press and other contraceptive methods at the community level through medical and nursing students. Sayana Press is similar in formulation to the injectable contraceptive Depo-Provera but contains a lower dose and is administered subcutaneously using a single-use syringe with a short needle called the Uniject system. The Uniject system allows Sayana Press to be administered by community health workers without clinical training or by self-injection. In this pilot, the advocacy objective was to obtain approval from the Ministry of Health to allow medical and nursing students to inject Sayana Press, as a first step toward authorization for community health workers to provide the method. The pilot described in this article documents a process whereby an innovative approach moved from concept to implementation to replication in less than 2 years. It also paved the way for testing additional progressive strategies to increase access to contraception at the community level. Because the pilot project included a research component designed to assess benefits and challenges, it provided the means to introduce the new task-shifting approach, which might not have been approved otherwise. Key pilot activities included: (1) increasing awareness of Sayana Press among family planning stakeholders at a national conference on family planning, (2) enlisting the support of key decision makers in designing the pilot, (3) obtaining marketing authorization to distribute Sayana Press in the DRC, (4) implementing the pilot from July to December 2015, (5) conducting quantitative and qualitative studies to assess acceptability and feasibility, and (6) disseminating the findings to family planning stakeholders. Before the pilot, Sayana Press was relatively unknown in the DRC, and there was no precedent for medical and nursing students providing family planning methods or giving injections at the community level. In less than 12 months, the approach gained legitimacy and acceptance. The key Ministry of Health decision maker orchestrated the closing session of the dissemination meeting on next steps, paving the way for pilot tests of 3 new task-shifting approaches: insertion of Implanon NXT by medical and nursing students, self-injection for Sayana Press with supervision by students, and injection of Sayana Press by community health workers with no formal clinical training. © Binanga and Bertrand.

A pilot study of maudsley family therapy with group dialectical behavior therapy skills training in an intensive outpatient program for adolescent eating disorders.

PubMed

Johnston, Jennifer A Y; O'Gara, Jesine S X; Koman, Stuart L; Baker, Christina Wood; Anderson, Drew A

2015-06-01

The goal of this study was to provide pilot clinical data on the effectiveness of an intensive outpatient treatment model for adolescent eating disorders that combines Maudsley-based family therapy and group dialectical behavior therapy skills training. Measures of physical and psychological status were gathered upon admission, discharge, and at 3 follow-up intervals. Adolescents who completed the program gained a significant amount of weight and experienced a significant decrease in eating disorder psychopathology. At the 1-year follow-up, 64% of adolescents were weight restored and menstruating normally. Measures of eating disorder psychopathology continued to improve up to a year after treatment. This pilot, multimodal program warrants further investigation and may be an effective intermediate level of care treatment option for adolescent eating disorders. © 2015 Wiley Periodicals, Inc.

The internal audit of clinical areas: a pilot of the internal audit methodology in a health service emergency department.

PubMed

Brown, Alison; Santilli, Mario; Scott, Belinda

2015-12-01

Governing bodies of health services need assurance that major risks to achieving the health service objectives are being controlled. Currently, the main assurance mechanisms generated within the organization are through the review of implementation of policies and procedures and review of clinical audits and quality data. The governing bodies of health services need more robust, objective data to inform their understanding of the control of clinical risks. Internal audit provides a methodological framework that provides independent and objective assurance to the governing body on the control of significant risks. The article describes the pilot of the internal audit methodology in an emergency unit in a health service. An internal auditor was partnered with a clinical expert to assess the application of clinical criteria based on best practice guidelines. The pilot of the internal audit of a clinical area was successful in identifying significant clinical risks that required further management. The application of an internal audit methodology to a clinical area is a promising mechanism to gain robust assurance at the governance level regarding the management of significant clinical risks. This approach needs further exploration and trial in a range of health care settings. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Implementation methods of medical image sharing for collaborative health care based on IHE XDS-I profile

PubMed Central

Zhang, Jianguo; Zhang, Kai; Yang, Yuanyuan; Sun, Jianyong; Ling, Tonghui; Wang, Mingqing; Bak, Peter

2015-01-01

Abstract. IHE XDS-I profile proposes an architecture model for cross-enterprise medical image sharing, but there are only a few clinical implementations reported. Here, we investigate three pilot studies based on the IHE XDS-I profile to see whether we can use this architecture as a foundation for image sharing solutions in a variety of health-care settings. The first pilot study was image sharing for cross-enterprise health care with federated integration, which was implemented in Huadong Hospital and Shanghai Sixth People’s Hospital within the Shanghai Shen-Kang Hospital Management Center; the second pilot study was XDS-I–based patient-controlled image sharing solution, which was implemented by the Radiological Society of North America (RSNA) team in the USA; and the third pilot study was collaborative imaging diagnosis with electronic health-care record integration in regional health care, which was implemented in two districts in Shanghai. In order to support these pilot studies, we designed and developed new image access methods, components, and data models such as RAD-69/WADO hybrid image retrieval, RSNA clearinghouse, and extension of metadata definitions in both the submission set and the cross-enterprise document sharing (XDS) registry. We identified several key issues that impact the implementation of XDS-I in practical applications, and conclude that the IHE XDS-I profile is a theoretically good architecture and a useful foundation for medical image sharing solutions across multiple regional health-care providers. PMID:26835497

Implementation methods of medical image sharing for collaborative health care based on IHE XDS-I profile.

PubMed

Zhang, Jianguo; Zhang, Kai; Yang, Yuanyuan; Sun, Jianyong; Ling, Tonghui; Wang, Mingqing; Bak, Peter

2015-10-01

IHE XDS-I profile proposes an architecture model for cross-enterprise medical image sharing, but there are only a few clinical implementations reported. Here, we investigate three pilot studies based on the IHE XDS-I profile to see whether we can use this architecture as a foundation for image sharing solutions in a variety of health-care settings. The first pilot study was image sharing for cross-enterprise health care with federated integration, which was implemented in Huadong Hospital and Shanghai Sixth People's Hospital within the Shanghai Shen-Kang Hospital Management Center; the second pilot study was XDS-I-based patient-controlled image sharing solution, which was implemented by the Radiological Society of North America (RSNA) team in the USA; and the third pilot study was collaborative imaging diagnosis with electronic health-care record integration in regional health care, which was implemented in two districts in Shanghai. In order to support these pilot studies, we designed and developed new image access methods, components, and data models such as RAD-69/WADO hybrid image retrieval, RSNA clearinghouse, and extension of metadata definitions in both the submission set and the cross-enterprise document sharing (XDS) registry. We identified several key issues that impact the implementation of XDS-I in practical applications, and conclude that the IHE XDS-I profile is a theoretically good architecture and a useful foundation for medical image sharing solutions across multiple regional health-care providers.

A pilot project using evidence-based clinical pathways and payment reform in China's rural hospitals shows early success.

PubMed

Cheng, Tsung-Mei

2013-05-01

Reforming China's public hospitals to curb widespread overtreatment and improve the quality and affordability of care has been the most challenging aspect of that nation's ambitious health reform, which began in 2009. This article describes a pilot project under way in several of China's provinces that combines payment reform with the implementation of evidence-based clinical pathways at a few hospitals serving rural areas. Results to date include reduced length-of-stay and prescription drug use and higher patient and provider satisfaction. These early results suggest that the pilot may be achieving its goals, which may have far-reaching and positive implications for China's ongoing reform.

Feasibility of cognitive remediation therapy for adults with autism spectrum disorders: a single-group pilot study.

PubMed

Okuda, Tomoko; Asano, Kenichi; Numata, Noriko; Hirano, Yoshiyuki; Yamamoto, Tetsuya; Tanaka, Mari; Matsuzawa, Daisuke; Shimizu, Eiji; Iyo, Masaomi; Nakazato, Michiko

2017-01-01

Set-shifting (SS) difficulties and weak central coherence (CC) are commonly associated with autism spectrum disorders (ASD). Cognitive remediation therapy (CRT) aims to improve such cognitive processing; however, there are no reports on CRT for patients with ASD. This pilot study aimed to provide preliminary evidence to support the use of CRT for individuals with ASD and provide data to inform future studies. Nineteen individuals with ASD were recruited and administered a series of neuropsychological and questionnaire measures to examine cognitive function and clinical outcomes such as anxiety and depression. Participants received CRT, and cognitive function and clinical variables were re-evaluated at postintervention and after 3 months. The participants demonstrated significant improvement in CC and anxiety at postintervention, which was maintained at 3-month follow-up. Although SS scores had improved with a large effect size, this was not statistically significant. CRT improved CC and anxiety scores for individuals with ASD, suggesting that CRT is an effective treatment for individuals with ASD.

Cognitive rehabilitation system for children with autism spectrum disorder using serious games: A pilot study.

PubMed

Aresti-Bartolome, Nuria; Garcia-Zapirain, Begonya

2015-01-01

This paper studies and assesses how rehabilitation activities and supervised computer games incorporated into a system aimed at people diagnosed with Autism Spectrum Disorder (ASD) can be used to work on the areas affected by ASD at any time and in any place. This research specifically assesses the areas that affect communication and interaction between people with ASD and professionals. In order to do this, a group of 20 children diagnosed with ASD of between 3 and 8 years old (clinical group) was used, together with a group of 20 children of between 3 and 8 years old with a neurotypical development, which served as a control group. During the tests, response time and visual interaction with the session leader were evaluated. Despite the fact that the clinical group spent more time (M = 21.08 sec) than the control group (M = 4.52) to interact leader, eye contact predominated in the interaction. As a result of the pilot study, the system obtained could help in cognitive rehabilitation.

Pilot non dialysis chronic renal insufficiency study (P-ND-CRIS): a pilot study of an open prospective hospital-based French cohort.

PubMed

Massol, Jacques; Janin, Gérard; Bachot, Camille; Gousset, Christophe; Deville, Geoffroy Sainte-Claire; Chalopin, Jean-Marc

2017-02-01

Before establishing a prospective cohort, an initial pilot study is recommended. However, there are no precise guidelines on this subject. This paper reports the findings of a French regional pilot study carried out in three nephrology departments, before realizing a major prospective Non Dialysis Chronic Renal Insufficiency study (ND-CRIS). We carried out an internal pilot study. The objectives of this pilot study were to validate the feasibility (regulatory approval, providing patients with information, availability of variables, refusal rate of eligible patients) and quality criteria (missing data, rate of patients lost to follow-up, characteristics of the patients included and non-included eligible patients, quality control of the data gathered) and estimate the human resources necessary (number of clinical research associates required). The authorizations obtained (CCTIRS - CNIL) and the contracts signed with hospitals have fulfilled the regulatory requirements. After validating the information on the study provided to patients, 1849 of them were included in three centres (university hospital, intercommunal hospital, town hospital) between April 2012 and September 2015. The low refusal rate (51 patients) and the characteristics of non-included patients have confirmed the benefit for patients of participating in the study and provide evidence of the feasibility and representativeness of the population studied. The lack of missing data on the variables studied, the quality of the data analyzed and the low number of patients lost to follow-up are evidence of the quality of the study. By taking into account the time spent by CRAs to enter data and to travel, as well as the annual patient numbers in each hospital, we estimate that five CRAs will be required in total. With no specific guidelines on how to realize a pilot study before implementing a major prospective cohort, we considered it pertinent to report our experience of P-ND-CRIS. This experience confirms that i) feasibility, ii) quality of data and iii) evaluating the resources required must be validated before carrying out a large prospective cohort study such as ND-CRIS.

A pilot Diabetic Support Service based on family practice attenders: comparison with diabetic clinics in east London.

PubMed

Boucher, B J; Claff, H R; Edmonson, M; Evans, S; Harris, B T; Hull, S A; Jones, E J; Mellins, D H; Safir, J G; Taylor, B

1987-01-01

A pilot Diabetic Support Service (DSS) based on a computer register was devised for diabetic patients identified within three group practices in an inner city district of London. Of 159 eligible diabetics, 142 were followed over 2 years. Glycosylated haemoglobin (GHb) monitoring and adequacy of clinic reviews were audited. Care achieved by the DSS was compared with conventional Diabetic Clinic (DC) management of a sample of 200 diabetics from the same district. Serial GHb measurements were made on 66.2% of DSS and 44.5% of DC patients: GHb fell significantly only in DSS patients (13.1% to 11.4%). Proportional falls in GHb were comparable in each DSS treatment group (diet alone, oral hypoglycaemic agents, and insulin) and for hospital attenders and non-attenders equally. The planned clinical reviews were achieved in 40.1% of DSS patients entered (29% GP only, 54% of clinic attenders) and in 15% of DC patients (plus 75% fundal and blood pressure examination). The study led to provision of a formal diabetic clinic annual review system, diabetic mini-clinics in two of the three group practices, and the appointment of two Diabetic Liaison Sisters. With administrative simplification the system is to be made available to all diabetics in the District through their GPs during 1986-8.

Teledermatology via a social networking web site: a pilot study between a general hospital and a rural clinic.

PubMed

Garcia-Romero, Maria Teresa; Prado, Fernanda; Dominguez-Cherit, Judith; Hojyo-Tomomka, Maria Teresa; Arenas, Roberto

2011-10-01

Teledermatology via a free public social networking Web site is a practical tool to provide attention to patients who do not have access to dermatologic care. In this pilot study, a general practitioner sent consults to a dermatology department at a general hospital via Facebook(®). Forty-four patients were seen and treatment was installed. We identified both simple-to-treat, common skin diseases and rare congenital diseases that require genetic counseling and more complex treatment. The majority of patients (75%) benefited with the diagnoses and treatments offered, thus avoiding unnecessary expenses or transportation to urban areas.

Guidelines for the Clinical Evaluation of Psychoactive Drugs in Infants and Children.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

These guidelines are intended to help those who design and conduct investigations of psychopharmacologic agents in children. A progression of studies in four phases is advocated. First, early short term studies should establish single and multiple dose safety baselines. Second, early pilot efficacy studies may be initiated jointly with longer…

Feasibility and Pilot Study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) Project

PubMed Central

Sun, Lena S.; Li, Guohua; DiMaggio, Charles J.; Byrne, Mary W.; Ing, Caleb; Miller, Tonya LK; Bellinger, David C.; Han, Sena; McGowan, Francis X.

2012-01-01

Background Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induce neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been performed using existing datasets, and produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at Columbia University Medical Center (CUMC) and Children’s Hospital of Boston (CHB) for the PANDA project. Methods The PANDA project uses an ambi-directional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs ages 6–11 years old. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair prior to age 36 months and the unexposed siblings had no anesthesia before age 36 months. All sibling pairs were English speaking and were 36 weeks gestational age or greater. Each sibling pair underwent direct testing using WASI and NEPSY II, and the parents completed questionnaires related to behavior using CBCL and Conners’ rating. Data are presented as means ± SD. We conducted descriptive analyses of demographic data. We compared exposed and unexposed sibling groups on WASI and NEPSY II, and total and T-scores from CBCL and Conners’ as continuous data by paired t test between. A P< 0.05 was considered significant. Results Following IRB approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. Scores for verbal IQ (Exposed=106.1±16.3,Unexposed=109.2±17.9), performance IQ (Exposed=109.1±16.0, Unexposed=113.9±15.9) and full IQ (Exposed=108.2±14.0, Unexposed=112.8±16.8) were comparable between siblings. There were no differences between the two groups in T scores for any of the NEPSY II sub-domains, CBCL or Conners’. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). Conclusions The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach, and yielded pilot data from neuropsychological testing. PMID:23076226

Exploring Organizational Characteristics Associated with Practice Changes Following a Mentored Online Educational Module

ERIC Educational Resources Information Center

Rappolt, Susan; Pearce, Kristine; McEwen, Sara; Polatajko, Helene J.

2005-01-01

Introduction: Studies of health professionals' perceptions of barriers to and facilitators of research utilization in clinical practices suggest that structural and resource characteristics of service provider organizations are key determinants of the capacity of individual practitioners to provide evidence-based practices. In this pilot study, we…

Metering Self-Reported Adherence to Clinical Outcomes in Malaysian Patients with Hypertension: Applying the Stages of Change Model to Healthful Behaviors in the CORFIS Study

ERIC Educational Resources Information Center

Karupaiah, Tilakavati; Wong, Kimberly; Chinna, Karuthan; Arasu, Kanimolli; Chee, Winnie Siew Swee

2015-01-01

The CORFIS ("Community-Based Cardiovascular Risk Factors Intervention Strategies") program was piloted in community clinics in Malaysia to address the lack of health education in chronic disease management. The stages of change model was applied in a multicenter quasi-experimental design to evaluate adherence to advocated behaviors in…

Can a brief two-hour interdisciplinary communication skills training be successful in undergraduate medical education?

PubMed

Bachmann, Cadja; Barzel, Anne; Roschlaub, Silke; Ehrhardt, Maren; Scherer, Martin

2013-11-01

To pilot-test feasibility, acceptance and learning-outcomes of a brief interdisciplinary communication skills training program in undergraduate medical education. A two-hour interdisciplinary communication skills program with simulated patients was developed and pilot-tested with clinical students at Hamburg University. Five psychosocial specialties facilitated the training. Composite effects were measured qualitatively and quantitatively. Eighty students volunteered to participate in the pilot-program (intervention-group). Their evaluations of the program were very positive (1.1 on a six-point scale). Benefits were seen in feedback, increase of self-confidence, cross-disciplinary clinical and communication experience. Students who did not volunteer (n=206) served as the control-group. The intervention-group performed significantly better (p=0.023) in a primary care communication examination and female students performed better than males. Clinical teachers evaluated the pilot-training very positively with regard to learning-outcomes and feasibility. The positive results from the pilot-training led to implementation into the regular curriculum. A two-hour interdisciplinary communication skills training program is beneficial for medical students with regard to communication competencies, self-confidence and learning-outcomes. The training is feasible within given time-frames and limited staff resources. The high teaching load for small-group-training are split between five specialties. The concept might be an interesting option for other faculties. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Statistical lessons learned for designing cluster randomized pragmatic clinical trials from the NIH Health Care Systems Collaboratory Biostatistics and Design Core.

PubMed

Cook, Andrea J; Delong, Elizabeth; Murray, David M; Vollmer, William M; Heagerty, Patrick J

2016-10-01

Pragmatic clinical trials embedded within health care systems provide an important opportunity to evaluate new interventions and treatments. Networks have recently been developed to support practical and efficient studies. Pragmatic trials will lead to improvements in how we deliver health care and promise to more rapidly translate research findings into practice. The National Institutes of Health (NIH) Health Care Systems Collaboratory was formed to conduct pragmatic clinical trials and to cultivate collaboration across research areas and disciplines to develop best practices for future studies. Through a two-stage grant process including a pilot phase (UH2) and a main trial phase (UH3), investigators across the Collaboratory had the opportunity to work together to improve all aspects of these trials before they were launched and to address new issues that arose during implementation. Seven Cores were created to address the various considerations, including Electronic Health Records; Phenotypes, Data Standards, and Data Quality; Biostatistics and Design Core; Patient-Reported Outcomes; Health Care Systems Interactions; Regulatory/Ethics; and Stakeholder Engagement. The goal of this article is to summarize the Biostatistics and Design Core's lessons learned during the initial pilot phase with seven pragmatic clinical trials conducted between 2012 and 2014. Methodological issues arose from the five cluster-randomized trials, also called group-randomized trials, including consideration of crossover and stepped wedge designs. We outlined general themes and challenges and proposed solutions from the pilot phase including topics such as study design, unit of randomization, sample size, and statistical analysis. Our findings are applicable to other pragmatic clinical trials conducted within health care systems. Pragmatic clinical trials using the UH2/UH3 funding mechanism provide an opportunity to ensure that all relevant design issues have been fully considered in order to reliably and efficiently evaluate new interventions and treatments. The integrity and generalizability of trial results can only be ensured if rigorous designs and appropriate analysis choices are an essential part of their research protocols. © The Author(s) 2016.

Integrating an internet-mediated walking program into family medicine clinical practice: a pilot feasibility study.

PubMed

Goodrich, David E; Buis, Lorraine R; Janney, Adrienne W; Ditty, Megan D; Krause, Christine W; Zheng, Kai; Sen, Ananda; Strecher, Victor J; Hess, Michael L; Piette, John D; Richardson, Caroline R

2011-06-24

Regular participation in physical activity can prevent many chronic health conditions. Computerized self-management programs are effective clinical tools to support patient participation in physical activity. This pilot study sought to develop and evaluate an online interface for primary care providers to refer patients to an Internet-mediated walking program called Stepping Up to Health (SUH) and to monitor participant progress in the program. In Phase I of the study, we recruited six pairs of physicians and medical assistants from two family practice clinics to assist with the design of a clinical interface. During Phase II, providers used the developed interface to refer patients to a six-week pilot intervention. Provider perspectives were assessed regarding the feasibility of integrating the program into routine care. Assessment tools included quantitative and qualitative data gathered from semi-structured interviews, surveys, and online usage logs. In Phase I, 13 providers used SUH and participated in two interviews. Providers emphasized the need for alerts flagging patients who were not doing well and the ability to review participant progress. Additionally, providers asked for summary views of data across all enrolled clinic patients as well as advertising materials for intervention recruitment. In response to this input, an interface was developed containing three pages: 1) a recruitment page, 2) a summary page, and 3) a detailed patient page. In Phase II, providers used the interface to refer 139 patients to SUH and 37 (27%) enrolled in the intervention. Providers rarely used the interface to monitor enrolled patients. Barriers to regular use of the intervention included lack of integration with the medical record system, competing priorities, patient disinterest, and physician unease with exercise referrals. Intention-to-treat analyses showed that patients increased walking by an average of 1493 steps/day from pre- to post-intervention (t = (36) = 4.13, p < 0.01). Providers successfully referred patients using the SUH provider interface, but were less willing to monitor patient compliance in the program. Patients who completed the program significantly increased their step counts. Future research is needed to test the effectiveness of integrating SUH with clinical information systems over a longer evaluation period.

Stochastic targeted (STAR) glycemic control: design, safety, and performance.

PubMed

Evans, Alicia; Le Compte, Aaron; Tan, Chia-Siong; Ward, Logan; Steel, James; Pretty, Christopher G; Penning, Sophie; Suhaimi, Fatanah; Shaw, Geoffrey M; Desaive, Thomas; Chase, J Geoffrey

2012-01-01

Tight glycemic control (TGC) has shown benefits but has been difficult to achieve consistently. STAR (Stochastic TARgeted) is a flexible, model-based TGC approach that directly accounts for intra- and interpatient variability with a stochastically derived maximum 5% risk of blood glucose (BG) below 72 mg/dl. This research assesses the safety, efficacy, and clinical burden of a STAR TGC controller modulating both insulin and nutrition inputs in virtual and clinical pilot trials. Clinically validated virtual trials using data from 370 patients in the SPRINT (Specialized Relative Insulin and Nutrition Titration) study were used to design the STAR protocol and test its safety, performance, and required clinical effort prior to clinical pilot trials. Insulin and nutrition interventions were given every 1-3 h as chosen by the nurse to allow them to manage workload. Interventions were designed to maximize the overlap of the model-predicted (5-95(th) percentile) range of BG outcomes with the 72-117 mg/dl band and thus provide a maximum 5% risk of BG <72 mg/dl. Interventions were calculated using clinically validated computer models of human metabolism and its variability in critical illness. Carbohydrate intake (all sources) was selected to maximize intake up to 100% of the American College of Chest Physicians/Society of Critical Care Medicine (ACCP/SCCM) goal (25 kg/kcal/h). Insulin doses were limited (8 U/h maximum), with limited increases based on current rate (0.5-2.0 U/h). Initial clinical pilot trials involved 3 patients covering ~450 h. Approval was granted by the Upper South A Regional Ethics Committee. Virtual trials indicate that STAR provides similar glycemic control performance to SPRINT with 2-3 h (maximum) measurement intervals. Time in the 72-126 mg/dl and 72-145 mg/dl bands was equivalent for all controllers, indicating that glycemic outcome differences between protocols were only shifted in this range. Safety from hypoglycemia was improved. Importantly, STAR using 2-3 h (maximum) intervention intervals reduced clinical burden up to 30%, which is clinically very significant. Initial clinical trials showed glycemic performance, safety, and management of inter- and intrapatient variability that matched or exceeded the virtual trial results. In virtual trials, STAR TGC provided tight control that maximized the likelihood of BG in a clinically specified glycemic band and reduced hypoglycemia with a maximum 5% (or lower) expected risk of light hypoglycemia (BG <72 mg/dl) via model-based management of intra- and interpatient variability. Clinical workload was self-managed and reduced up to 30% compared with SPRINT. Initial pilot clinical trials matched or exceeded these virtual results. © 2012 Diabetes Technology Society.

Development of a tool to support holistic generic assessment of clinical procedure skills.

PubMed

McKinley, Robert K; Strand, Janice; Gray, Tracey; Schuwirth, Lambert; Alun-Jones, Tom; Miller, Helen

2008-06-01

The challenges of maintaining comprehensive banks of valid checklists make context-specific checklists for assessment of clinical procedural skills problematic. This paper reports the development of a tool which supports generic holistic assessment of clinical procedural skills. We carried out a literature review, focus groups and non-participant observation of assessments with interview of participants, participant evaluation of a pilot objective structured clinical examination (OSCE), a national modified Delphi study with prior definitions of consensus and an OSCE. Participants were volunteers from a large acute teaching trust, a teaching primary care trust and a national sample of National Health Service staff. Results In total, 86 students, trainees and staff took part in the focus groups, observation of assessments and pilot OSCE, 252 in the Delphi study and 46 candidates and 50 assessors in the final OSCE. We developed a prototype tool with 5 broad categories amongst which were distributed 38 component competencies. There was > 70% agreement (our prior definition of consensus) at the first round of the Delphi study for inclusion of all categories and themes and no consensus for inclusion of additional categories or themes. Generalisability was 0.76. An OSCE based on the instrument has a predicted reliability of 0.79 with 12 stations and 1 assessor per station or 10 stations and 2 assessors per station. This clinical procedural skills assessment tool enables reliable assessment and has content and face validity for the assessment of clinical procedural skills. We have designated it the Leicester Clinical Procedure Assessment Tool (LCAT).

Tetherless ergonomics workstation to assess nurses' physical workload in a clinical setting.

PubMed

Smith, Warren D; Nave, Michael E; Hreljac, Alan P

2011-01-01

Nurses are at risk of physical injury when moving immobile patients. This paper describes the development and testing of a tetherless ergonomics workstation that is suitable for studying nurses' physical workload in a clinical setting. The workstation uses wearable sensors to record multiple channels of body orientation and muscle activity and wirelessly transmits them to a base station laptop computer for display, storage, and analysis. In preparation for use in a clinical setting, the workstation was tested in a laboratory equipped for multi-camera video motion analysis. The testing included a pilot study of the effect of bed height on student nurses' physical workload while they repositioned a volunteer posing as a bedridden patient toward the head of the bed. Each nurse subject chose a preferred bed height, and data were recorded, in randomized order, with the bed at this height, at 0.1 m below this height, and at 0.1 m above this height. The testing showed that the body orientation recordings made by the wearable sensors agreed closely with those obtained from the video motion analysis system. The pilot study showed the following trends: As the bed height was raised, the nurses' trunk flexion at both thoracic and lumbar sites and lumbar muscle effort decreased, whereas trapezius and deltoid muscle effort increased. These trends will be evaluated by further studies of practicing nurses in the clinical setting.

A brief report on the development of a theoretically-grounded intervention to promote patient autonomy and self-management of physiotherapy patients: face validity and feasibility of implementation.

PubMed

Matthews, James; Hall, Amanda M; Hernon, Marian; Murray, Aileen; Jackson, Ben; Taylor, Ian; Toner, John; Guerin, Suzanne; Lonsdale, Chris; Hurley, Deirdre A

2015-07-05

Clinical practice guidelines for the treatment of low back pain suggest the inclusion of a biopsychosocial approach in which patient self-management is prioritized. While many physiotherapists recognise the importance of evidence-based practice, there is an evidence practice gap that may in part be due to the fact that promoting self-management necessitates change in clinical behaviours. Evidence suggests that a patient's motivation and maintenance of self-management behaviours can be positively influenced by the clinician's use of an autonomy supportive communication style. Therefore, the aim of this study was to develop and pilot-test the feasibility of a theoretically derived implementation intervention to support physiotherapists in using an evidence-based autonomy supportive communication style in practice for promoting patient self-management in clinical practice. A systematic process was used to develop the intervention and pilot-test its feasibility in primary care physiotherapy. The development steps included focus groups to identify barriers and enablers for implementation, the theoretical domains framework to classify determinants of change, a behaviour change technique taxonomy to select appropriate intervention components, and forming a testable theoretical model. Face validity and acceptability of the intervention was pilot-tested with two physiotherapists and monitoring their communication with patients over a three-month timeframe. Using the process described above, eight barriers and enablers for implementation were identified. To address these barriers and enablers, a number of intervention components were selected ranging from behaviour change techniques such as, goal-setting, self-monitoring and feedback to appropriate modes of intervention delivery (i.e. continued education meetings and audit and feedback focused coaching). Initial pilot-testing revealed the acceptability of the intervention to recipients and highlighted key areas for refinement prior to scaling up for a definitive trial. The development process utilised in this study ensured the intervention was theory-informed and evidence-based, with recipients signalling its relevance and benefit to their clinical practice. Future research should consider additional intervention strategies to address barriers of social support and those beyond the clinician level.

Integrated care pilot in north-west London: a mixed methods evaluation

PubMed Central

Curry, Natasha; Harris, Matthew; Gunn, Laura H.; Pappas, Yannis; Blunt, Ian; Soljak, Michael; Mastellos, Nikolaos; Holder, Holly; Smith, Judith; Majeed, Azeem; Ignatowicz, Agnieszka; Greaves, Felix; Belsi, Athina; Costin-Davis, Nicola; Jones Nielsen, Jessica D.; Greenfield, Geva; Cecil, Elizabeth; Patterson, Susan; Car, Josip; Bardsley, Martin

2013-01-01

Introduction This paper provides the results of a year-long evaluation of a large-scale integrated care pilot in north-west London. The pilot aimed to integrate care across primary, acute, community, mental health and social care for people with diabetes and/or those aged 75+ through care planning, multidisciplinary case reviews, information sharing and project management support. Methods The evaluation team conducted qualitative studies of change at organisational, clinician and patient levels (using interviews, focus groups and a survey); and quantitative analysis of change in service use and patient-level clinical outcomes (using patient-level datasets and a matched control study). Results The pilot had successfully engaged provider organisations, created a shared strategic vision and established governance structures. However, the engagement of clinicians was variable and there was no evidence to date of significant reductions in emergency admissions. There was some evidence of changes in care processes. Conclusion Although the pilot has demonstrated the beginnings of large-scale change, it remains in the early stages and faces significant challenges as it seeks to become sustainable for the longer term. It is critical that National Health Service managers and clinicians have realistic expectations of what can be achieved in a relatively short period of time. PMID:24167455

Structural empowerment and anticipated turnover among behavioural health nurses.

PubMed

Smith, Thomas; Capitulo, Kathleen Leask; Quinn Griffin, Mary T; Fitzpatrick, Joyce J

2012-07-01

The aim of this pilot study was to examine the relationship between structural empowerment and anticipated turnover among behavioural health nurses. There have been several studies relating structural empowerment to a range of organizational characteristics and personal attributes of nurses themselves. There are also previous studies linking the key variables in the present study, but no previous research of behavioural health nurses was available. A quantitative design was used for this cross-sectional pilot study. All registered nurses (RN) working on inpatient units in the study facility were invited to participate (n = 97). An anonymous survey was sent to all potential participants. The response rate was 53% (n = 50). The majority of participants perceived themselves as moderately empowered. There was a significant negative correlation between empowerment and anticipated turnover. The results of this pilot study among behavioural health nurses are similar to the results among nurses working in other clinical areas. Nurse managers should be cognizant of the factors that enhance nurses' perceptions of empowerment, particularly related to issues of retention and anticipated turnover among behavioural health nurses. © 2012 Blackwell Publishing Ltd.

The Resident-Run Minor Surgery Clinic: A Pilot Study to Safely Increase Operative Autonomy.

PubMed

Wojcik, Brandon M; Fong, Zhi Ven; Patel, Madhukar S; Chang, David C; Petrusa, Emil; Mullen, John T; Phitayakorn, Roy

General surgery training has evolved to align with changes in work hour restrictions, supervision regulations, and reimbursement practices. This has culminated in a lack of operative autonomy, leaving residents feeling inadequately prepared to perform surgery independently when beginning fellowship or practice. A resident-run minor surgery clinic increases junior resident autonomy, but its effects on patient outcomes have not been formally established. This pilot study evaluated the safety of implementing a resident-run minor surgery clinic within a university-based general surgery training program. Single institution case-control pilot study of a resident-run minor surgery clinic from 9/2014 to 6/2015. Rotating third-year residents staffed the clinic once weekly. Residents performed operations independently in their own procedure room. A supervising attending surgeon staffed each case prior to residents performing the procedure and viewed the surgical site before wound closure. Postprocedure patient complications and admissions to the hospital because of a complication were analyzed and compared with an attending control cohort. Massachusetts General Hospital General in Boston, MA; an academic tertiary care general surgery residency program. Ten third-year general surgery residents. Overall, 341 patients underwent a total of 399 procedures (110 in the resident clinic vs. 289 in the attending clinic). Minor surgeries included soft tissue mass excision (n = 275), abscess incision and drainage (n = 66), skin lesion excision (n = 37), skin tag removal (n = 15), and lymph node excision (n = 6). There was no significant difference in the overall rate of patients developing a postprocedure complication within 30 days (3.6% resident vs. 2.8% attending; p = 0.65); which persisted on multivariate analysis. Similar findings were observed for the rate of hospital admission resulting from a complication. Resident evaluations overwhelmingly supported the rotation, citing increased operative autonomy as the greatest strength. Implementation of a resident-run minor surgery clinic is a safe and effective method to increase trainee operative autonomy. The rotation is well suited for mid-level residents, as it provides an opportunity for realistic self-evaluation and focused learning that may enhance their operative experience during senior level rotations. Copyright © 2016 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Low signal intensity in motor cortex on susceptibility-weighted MR imaging is correlated with clinical signs of amyotrophic lateral sclerosis: a pilot study.

PubMed

Endo, Hironobu; Sekiguchi, Kenji; Shimada, Hitoshi; Ueda, Takehiro; Kowa, Hisatomo; Kanda, Fumio; Toda, Tatsushi

2018-03-01

There is no reliable objective indicator for upper motor neuron dysfunction in amyotrophic lateral sclerosis (ALS). To determine the clinical significance and potential utility of magnetic resonance (MR) signals, we investigated the relationship between clinical symptoms and susceptibility changes in the motor cortex measured using susceptibility-weighted MR imaging taken by readily available 3-T MRI in clinical practice. Twenty-four ALS patients and 14 control subjects underwent 3-T MR T1-weighted imaging and susceptibility-weighted MR imaging with the principles of echo-shifting with a train of observations (PRESTO) sequence. We analysed relationships between relative susceptibility changes in the motor cortex assessed using voxel-based analysis (VBA) and clinical scores, including upper motor neuron score, ALS functional rating scale revised score, and Medical Research Council sum score on physical examination. Patients with ALS exhibited significantly lower signal intensity in the precentral gyrus on susceptibility-weighted MR imaging compared with controls. Clinical scores were significantly correlated with susceptibility changes. Importantly, the extent of the susceptibility changes in the bilateral precentral gyri was significantly correlated with upper motor neuron scores. The results of our pilot study using VBA indicated that low signal intensity in motor cortex on susceptibility-weighted MR imaging may correspond to clinical symptoms, particularly upper motor neuron dysfunction. Susceptibility-weighted MR imaging may be a useful diagnostic tool as an objective indicator of upper motor neuron dysfunction.

Developing the Translational Research Workforce: A Pilot Study of Common Metrics for Evaluating the Clinical and Translational Award KL2 Program

PubMed Central

Guerrero, Lourdes; Jones, Lisa B.; Tong, Greg; Ireland, Christine; Dumbauld, Jill; Rainwater, Julie

2015-01-01

Abstract Purpose This pilot study describes the career development programs (i.e., NIH KL2 awards) across five Clinical and Translational Science Award (CTSA) institutions within the University of California (UC) system, and examines the feasibility of a set of common metrics for evaluating early outcomes. Methods A survey of program administrators provided data related to the institutional environment within which each KL2 program was implemented. Application and progress report data yielded a combined data set that characterized KL2 awardees, their initial productivity, and early career outcomes. Results The pilot project demonstrated the feasibility of aggregating common metrics data across multiple institutions. The data indicated that KL2 awardees were an accomplished set of investigators, both before and after the award period, representing a wide variety of disciplines. Awardees that had completed their trainee period overwhelmingly remained active in translational research conducted within an academic setting. Early indications also suggest high rates of success with obtaining research funding subsequent to the KL2 award. Conclusion This project offers a model for how to collect and analyze common metrics related to the education and training function of the CTSA Consortium. Next steps call for expanding participation to other CTSA sites outside of the University of California system. PMID:26602332

Developing and Pilot Testing the Readiness and Motivation Interview for Families in Pediatric Weight Management.

PubMed

Geller, Josie; Avis, Jillian; Srikameswaran, Suja; Zelichowska, Joanna; Dartnell, Katie; Scheuerman, Bailey; Perez, Arnaldo; Rasquinha, Allison; Brown, Krista E; Chanoine, Jean-Pierre; Ball, Geoff

2015-12-01

Clinical acumen is often used to assess families' motivation prior to initiating pediatric obesity management due to a lack of available tools. The purpose of this pilot study was to (i) develop and (ii) pilot test the "Readiness and Motivation Interview for Families" (RMI-Family) in pediatric weight management. We conducted 5 focus groups with parents (n = 15), youth with obesity (n = 11), and health care providers (n = 8) to explore perceptions of barriers to making healthy behaviour changes, which led to the creation of the RMI-Family as a semi-structured interview. Five domains (treat foods, overeating, emotional eating, total physical activity, and screen time) emerged from the focus groups to inform the development of the RMI-Family, which was then pilot tested with a sample of youth with obesity and their parents (n = 11 dyads). Interviewers administered the RMI-Family to youth (age 12.8 ± 1.7 years; body mass index [BMI] z-score: 2.71 ± 0.43) and parents (age 47.1 ± 3.7 years; BMI: 33.5 ± 10.1 kg/m(2)). The RMI-Family was feasible to administer, easily understood by families, and may be a useful tool for assessing families' motivation. Research is underway to determine the psychometric properties and utility of the RMI-Family in predicting clinical outcomes in pediatric weight management.

Co-Designing Mobile Apps to Assist in Clinical Nursing Education: A Study Protocol.

PubMed

O'Connor, Siobhan; Andrews, Tom

2016-01-01

Mobile applications (apps) to train health professionals is gaining momentum as the benefits of mobile learning (mLearning) are becoming apparent in complex clinical environments. However, most educational apps are generic, off-the-shelf pieces of software that do not take into consideration the unique needs of nursing students. The proposed study will apply a user-centred design process to create a tailored mobile app for nursing students to learn and apply clinical skills in practice. The app will be piloted and evaluated to understand how nursing students use mobile technology in clinical settings to support their learning and educational needs.

The feasibility of conducting a randomised controlled trial comparing arthroscopic hip surgery to conservative care for patients with femoroacetabular impingement syndrome: the FASHIoN feasibility study.

PubMed

Griffin, D R; Dickenson, E J; Wall, P D H; Realpe, A; Adams, A; Parsons, N; Hobson, R; Achten, J; Costa, M L; Foster, N E; Hutchinson, C E; Petrou, S; Donovan, J L

2016-10-01

To determine whether it was feasible to perform a randomized controlled trial (RCT) comparing arthroscopic hip surgery to conservative care in patients with femoroacetabular impingement (FAI). This study had two phases: a pre-pilot and pilot RCT. In the pre-pilot, we conducted interviews with clinicians who treated FAI and with FAI patients to determine their views about an RCT. We developed protocols for operative and conservative care. In the pilot RCT, we determined the rates of patient eligibility, recruitment and retention, to investigate the feasibility of the protocol and we established methods to assess treatment fidelity. In the pre-pilot phase, 32 clinicians were interviewed, of which 26 reported theoretical equipoise, but in example scenarios 7 failed to show clinical equipoise. Eighteen patients treated for FAI were also interviewed, the majority of whom felt that surgery and conservative care were acceptable treatments. Surgery was viewed by patients as a 'definitive solution'. Patients were motivated to participate in research but were uncomfortable about randomization. Randomization was more acceptable if the alternative was available at the end of the trial. In the pilot phase, 151 patients were assessed for eligibility. Sixty were eligible and invited to take part in the pilot RCT; 42 consented to randomization. Follow-up was 100% at 12 months. Assessments of treatment fidelity were satisfactory. An RCT to compare arthroscopic hip surgery with conservative care in patients with FAI is challenging but feasible. Recruitment has started for a full RCT.

3D ultrasound computer tomography: update from a clinical study

NASA Astrophysics Data System (ADS)

Hopp, T.; Zapf, M.; Kretzek, E.; Henrich, J.; Tukalo, A.; Gemmeke, H.; Kaiser, C.; Knaudt, J.; Ruiter, N. V.

2016-04-01

Ultrasound Computer Tomography (USCT) is a promising new imaging method for breast cancer diagnosis. We developed a 3D USCT system and tested it in a pilot study with encouraging results: 3D USCT was able to depict two carcinomas, which were present in contrast enhanced MRI volumes serving as ground truth. To overcome severe differences in the breast shape, an image registration was applied. We analyzed the correlation between average sound speed in the breast and the breast density estimated from segmented MRIs and found a positive correlation with R=0.70. Based on the results of the pilot study we now carry out a successive clinical study with 200 patients. For this we integrated our reconstruction methods and image post-processing into a comprehensive workflow. It includes a dedicated DICOM viewer for interactive assessment of fused USCT images. A new preview mode now allows intuitive and faster patient positioning. We updated the USCT system to decrease the data acquisition time by approximately factor two and to increase the penetration depth of the breast into the USCT aperture by 1 cm. Furthermore the compute-intensive reflectivity reconstruction was considerably accelerated, now allowing a sub-millimeter volume reconstruction in approximately 16 minutes. The updates made it possible to successfully image first patients in our ongoing clinical study.

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.

Education research: evaluating the use of podcasting for residents during EEG instruction: a pilot study.

PubMed

Bensalem-Owen, Meriem; Chau, Destiny F; Sardam, Sean C; Fahy, Brenda G

2011-08-23

Educational methods for residents are shifting toward greater learner independence aided by technological advances. A Web-based program using a podcast was created for resident EEG instruction, replacing conventional didactics. The EEG curriculum also consisted of EEG interpretations under the tutelage of a neurophysiologist. This pilot study aimed to objectively evaluate the effectiveness of the podcast as a new teaching tool. A podcast for resident EEG instruction was implemented on the Web, replacing the traditional lecture. After Institutional Review Board approval, consent was obtained from the participating residents. Using 25-question evaluation tools, participants were assessed at baseline before any EEG instruction, and reassessed after podcasting and after 10 clinical EEG exposures. Each 25-item evaluation tool contained tracings used for clinical EEG interpretations. Scores after podcast training were also compared to scores after traditional didactic training from a previous study among anesthesiology trainees. Ten anesthesiology residents completed the study. The mean scores with standard deviations are 9.50 ± 2.92 at baseline, 13.40 ± 3.31 (p = 0.034) after the podcast, and 16.20 ± 1.87 (p = 0.019) after interpreting 10 EEGs. No differences were noted between the mean educational tool scores for those who underwent podcasting training compared to those who had undergone traditional didactic training. In this pilot study, podcast training was as effective as the prior conventional lecture in meeting the curricular goals of increasing EEG knowledge after 10 EEG interpretations as measured by assessment tools.

Clinical Outcome, Social Impact and Patient Expectation: a Purposive Sampling Pilot Evaluation of Patients in Benin Seven Years After Surgery.

PubMed

White, Michelle C; Randall, Kirsten; Avara, Esther; Mullis, Jenny; Parker, Gary; Shrime, Mark G

2018-05-01

Access to affordable and timely surgery is not equitable around the world. Five billion people lack access, and while non-governmental organizations (NGOs) help to meet this need, long-term surgical outcomes, social impact or patient experience is rarely reported. In 2016, Mercy Ships, a surgical NGO, undertook an evaluation of patients who had received surgery seven years earlier with Mercy Ships in 2009 in Benin. Using purposive sampling, patients who had received maxillofacial, plastics or orthopedic surgery were invited to attend a surgical evaluation day. In this pilot study, we used semi-structured interviews and questionnaire responses to assess patient expectation, surgical and social outcome. Our results show that seven years after surgery 35% of patients report surgery-related pain and 18% had sought further care for a clinical complication of their condition. However, 73% of patients report gaining social benefit from surgery, and overall patient satisfaction was 89%, despite 35% of patients saying that they were unclear what to expect after surgery indicating a mismatch of doctor/patient expectations and failure of the consent process. In conclusion, our pilot study shows that NGO surgery in Benin provided positive social impact associated with complication rates comparable to high-income countries when assessed seven years later. Key areas for further study in LMICs are: evaluation and treatment of chronic pain, consent and access to further care.

Indicators of quality of antenatal care: a pilot study.

PubMed

Vause, S; Maresh, M

1999-03-01

To pilot a list of indicators of quality of antenatal care across a range of maternity care settings. For each indicator to determine what is achieved in current clinical practice, to facilitate the setting of audit standards and calculation of appropriate sample sizes for audit. A multicentre retrospective observational study. Nine maternity units in the United Kingdom. 20,771 women with a singleton pregnancy, who were delivered between 1 August 1994 and 31 July 1995. Nine of the eleven suggested indicators were successfully piloted. Two indicators require further development. In seven of the nine hospitals external cephalic version was not commonly performed. There were wide variations in the proportions of women screened for asymptomatic bacteriuria. Screening of women from ethnic minorities for haemoglobinopathy was more likely in hospitals with a large proportion of non-caucasian women. A large number of Rhesus negative women did not have a Rhesus antibody check performed after 28 weeks of gestation and did not receive anti-D immunoglobulin after a potentially sensitising event during pregnancy. As a result of the study appropriate sample sizes for future audit could be calculated. Measuring the extent to which evidence-based interventions are used in routine clinical practice provides a more detailed picture of the strengths and weaknesses in an antenatal service than traditional outcomes such as perinatal mortality rates. Awareness of an appropriate sample size should prevent waste of time and resources on inconclusive audits.

Clinical outcomes of a novel therapeutic vaccine with Tax peptide-pulsed dendritic cells for adult T cell leukaemia/lymphoma in a pilot study.

PubMed

Suehiro, Youko; Hasegawa, Atsuhiko; Iino, Tadafumi; Sasada, Amane; Watanabe, Nobukazu; Matsuoka, Masao; Takamori, Ayako; Tanosaki, Ryuji; Utsunomiya, Atae; Choi, Ilseung; Fukuda, Tetsuya; Miura, Osamu; Takaishi, Shigeo; Teshima, Takanori; Akashi, Koichi; Kannagi, Mari; Uike, Naokuni; Okamura, Jun

2015-05-01

Adult T cell leukaemia/lymphoma (ATL) is a human T cell leukaemia virus type-I (HTLV-I)-infected T cell malignancy with poor prognosis. We herein developed a novel therapeutic vaccine designed to augment an HTLV-I Tax-specific cytotoxic T lymphocyte (CTL) response that has been implicated in anti-ATL effects, and conducted a pilot study to investigate its safety and efficacy. Three previously treated ATL patients, classified as intermediate- to high-risk, were subcutaneously administered with the vaccine, consisting of autologous dendritic cells (DCs) pulsed with Tax peptides corresponding to the CTL epitopes. In all patients, the performance status improved after vaccination without severe adverse events, and Tax-specific CTL responses were observed with peaks at 16-20 weeks. Two patients achieved partial remission in the first 8 weeks, one of whom later achieved complete remission, maintaining their remission status without any additional chemotherapy 24 and 19 months after vaccination, respectively. The third patient, whose tumour cells lacked the ability to express Tax at biopsy, obtained stable disease in the first 8 weeks and later developed slowly progressive disease although additional therapy was not required for 14 months. The clinical outcomes of this pilot study indicate that the Tax peptide-pulsed DC vaccine is a safe and promising immunotherapy for ATL. © 2015 John Wiley & Sons Ltd.

Child Directed Interaction Training for young children in kinship care: A pilot study.

PubMed

N'zi, Amanda M; Stevens, Monica L; Eyberg, Sheila M

2016-05-01

This pilot study used a randomized controlled trial design to examine the feasibility and explore initial outcomes of a twice weekly, 8-session Child Directed Interaction Training (CDIT) program for children living in kinship care. Participants included 14 grandmothers and great-grandmothers with their 2- to 7-year-old children randomized either to CDIT or a waitlist control condition. Training was delivered at a local, community library with high fidelity to the training protocol. There was no attrition in either condition. After training, kinship caregivers in the CDIT condition demonstrated more positive relationships with their children during behavioral observation. The caregivers in the CDIT condition also reported clinically and statistically significant decreases in parenting stress and caregiver depression, as well as fewer externalizing child behavior problems than waitlist controls. Parent daily report measures indicated significant changes in disciplining that included greater use of limit-setting and less use of critical verbal force. Results appeared stable at 3-month follow-up. Changes in child internalizing behaviors and caregiver use of non-critical verbal force were not seen until 3-month follow-up. Results of this pilot study suggest both the feasibility of conducting full scale randomized clinical trials of CDIT in the community and the promise of this approach for providing effective parent training for kinship caregivers. Copyright © 2016 Elsevier Ltd. All rights reserved.

Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study.

PubMed

Benhamou, Pierre Yves; Huneker, Erik; Franc, Sylvia; Doron, Maeva; Charpentier, Guillaume

2018-06-01

Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach. A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters. Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70-180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses. This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety. This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.

Saffron in phytotherapy: pharmacology and clinical uses.

PubMed

Schmidt, Mathias; Betti, Georges; Hensel, Andreas

2007-01-01

Saffron (stigmata of Crocus sativus L.) has been used for medicinal purposes for millennia. Throughout history, uses against cancer and depressive mood can regularly be identified. These applications have also been in the focus of modern research. Promising and selective anti-cancer effects have been observed in vitro and in vivo, but not yet in clinical trials. Antidepressant effects were found in vivo and in clinical pilot studies. Saffron extracts thus have the potential to make a major contribution to rational phytotherapy.

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7)

PubMed Central

Deal, Linda S.; DiBenedetti, Dana B.; Nelson, Lauren; Fehnel, Sheri E.; Brown, T. Michelle

2016-01-01

Objective Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Methods Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014–July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Results Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Conclusions Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED. PMID:27486542

Development of the 7-Item Binge-Eating Disorder Screener (BEDS-7).

PubMed

Herman, Barry K; Deal, Linda S; DiBenedetti, Dana B; Nelson, Lauren; Fehnel, Sheri E; Brown, T Michelle

2016-01-01

Develop a brief, patient-reported screening tool designed to identify individuals with probable binge-eating disorder (BED) for further evaluation or referral to specialists. Items were developed on the basis of the DSM-5 diagnostic criteria, existing tools, and input from 3 clinical experts (January 2014). Items were then refined in cognitive debriefing interviews with participants self-reporting BED characteristics (March 2014) and piloted in a multisite, cross-sectional, prospective, noninterventional study consisting of a semistructured diagnostic interview (to diagnose BED) and administration of the pilot Binge-Eating Disorder Screener (BEDS), Binge Eating Scale (BES), and RAND 36-Item Short-Form Health Survey (RAND-36) (June 2014-July 2014). The sensitivity and specificity of classification algorithms (formed from the pilot BEDS item-level responses) in predicting BED diagnosis were evaluated. The final algorithm was selected to minimize false negatives and false positives, while utilizing the fewest number of BEDS items. Starting with the initial BEDS item pool (20 items), the 13-item pilot BEDS resulted from the cognitive debriefing interviews (n = 13). Of the 97 participants in the noninterventional study, 16 were diagnosed with BED (10/62 female, 16%; 6/35 male, 17%). Seven BEDS items (BEDS-7) yielded 100% sensitivity and 38.7% specificity. Participants correctly identified (true positives) had poorer BES scores and RAND-36 scores than participants identified as true negatives. Implementation of the brief, patient-reported BEDS-7 in real-world clinical practice is expected to promote better understanding of BED characteristics and help physicians identify patients who may have BED.

A pilot study examining experiential learning vs didactic education of abdominal compartment syndrome.

PubMed

Saraswat, Anju; Bach, John; Watson, William D; Elliott, John O; Dominguez, Edward P

2017-08-01

Current surgical education relies on simulated educational experiences or didactic sessions to teach low-frequency clinical events such as abdominal compartment syndrome (ACS). The purpose of this pilot study was to evaluate if simulation would improve performance and knowledge retention of ACS better than a didactic lecture. Nineteen general surgery residents were block randomized by postgraduate year level to a didactic or a simulation session. After 3 months, all residents completed a knowledge assessment before participating in an additional simulation. Two independent reviewers assessed resident performance via audio-video recordings. No baseline differences in ACS experience were noted between groups. The observational evaluation demonstrated a significant difference in performance between the didactic and simulation groups: 9.9 vs 12.5, P = .037 (effect size = 1.15). Knowledge retention was equivalent between groups. This pilot study suggests that simulation-based education may be more effective for teaching the basic concepts of ACS. Copyright © 2016 Elsevier Inc. All rights reserved.

A Pilot Study of a Distress Tolerance Treatment for Opiate Dependent Patients Initiating Buprenorphine: Rationale, Methodology, and Outcomes

PubMed Central

Brown, Richard A.; Bloom, Erika Litvin; Hecht, Jacki; Moitra, Ethan; Herman, Debra S.; Stein, Michael D.

2016-01-01

Buprenorphine, an opioid that is a long-acting partial opiate agonist, is an efficacious treatment for opiate dependence that is growing in popularity. Nevertheless, evidence suggests that many patients will lapse within the first week of treatment, and that lapses are often associated with withdrawal-related or emotional distress. Recent research suggests that individuals’ reactions to this distress may represent an important treatment target. In the current study, we describe the development and outcomes from a preliminary pilot evaluation (N = 5) of a novel distress tolerance treatment for individuals initiating buprenorphine. This treatment incorporates exposure-based and acceptance-based treatment approaches that we have previously applied to the treatment of tobacco dependence. Results from this pilot study establish the feasibility and acceptability of this approach. We are now conducting a randomized controlled trial of this treatment that we hope will yield clinically significant findings and offer clinicians an efficacious behavioral treatment to complement the effects of buprenorphine. PMID:24973401

Pilot study of erlotinib in patients with acute myeloid leukemia.

PubMed

Sayar, Hamid; Czader, Magdalena; Amin, Chirag; Cangany, Mary; Konig, Heiko; Cripe, Larry D

2015-02-01

We conducted a pilot study to investigate clinical efficacy of tyrosine kinase inhibitor erlotinib in the treatment of acute myeloid leukemia (AML). A total of 11 patients with de novo AML were treated, including 2 with relapsed and/or refractory disease and 9 older patients with previously untreated AML. Patients with high baseline leukocyte count were excluded. Erlotinib was given orally at 150 mg per day continuously in 28-day cycles. The treatment was tolerated well, and no toxicities were observed. An initial reduction in circulating blasts, followed by disease progression, was observed in 2 patients. Nine other patients did not demonstrate any response in blood or bone marrow. Baseline and post-cycle 1 flow-cytometry were performed on bone marrow blasts to investigate signs of differentiation. No immunophenotypic changes suggestive of differentiation were observed. This pilot study did not demonstrate response to standard doses of erlotinib in patients with AML. Copyright © 2014 Elsevier Ltd. All rights reserved.

White matter hyperintensities on MRI in high-altitude U-2 pilots.

PubMed

McGuire, Stephen; Sherman, Paul; Profenna, Leonardo; Grogan, Patrick; Sladky, John; Brown, Anthony; Robinson, Andrew; Rowland, Laura; Hong, Elliot; Patel, Beenish; Tate, David; Kawano, Elaine S; Fox, Peter; Kochunov, Peter

2013-08-20

To demonstrate that U-2 pilot occupational exposure to hypobaria leads to increased incidence of white matter hyperintensities (WMH) with a more uniform distribution throughout the brain irrespective of clinical neurologic decompression sickness history. We evaluated imaging findings in 102 U-2 pilots and 91 controls matched for age, health, and education levels. Three-dimensional, T2-weighted, high-resolution (1-mm isotropic) imaging data were collected using fluid-attenuated inversion recovery sequence on a 3-tesla MRI scanner. Whole-brain and regional WMH volume and number were compared between groups using a 2-tailed Wilcoxon rank sum test. U-2 pilots demonstrated an increase in volume (394%; p = 0.004) and number (295%; p < 0.001) of WMH. Analysis of regional distribution demonstrated WMH more uniformly distributed throughout the brain in U-2 pilots compared with mainly frontal distribution in controls. Pilots with occupational exposure to hypobaria showed a significant increase in WMH lesion volume and number. Unlike the healthy controls with predominantly WMH in the frontal white matter, WMH in pilots were more uniformly distributed throughout the brain. This is consistent with our hypothesized pattern of damage produced by interaction between microemboli and cerebral tissue, leading to thrombosis, coagulation, inflammation, and/or activation of innate immune response, although further studies will be necessary to clarify the pathologic mechanisms responsible.

White matter hyperintensities on MRI in high-altitude U-2 pilots

PubMed Central

Sherman, Paul; Profenna, Leonardo; Grogan, Patrick; Sladky, John; Brown, Anthony; Robinson, Andrew; Rowland, Laura; Hong, Elliot; Patel, Beenish; Tate, David; Kawano, Elaine S.; Fox, Peter; Kochunov, Peter

2013-01-01

Objective: To demonstrate that U-2 pilot occupational exposure to hypobaria leads to increased incidence of white matter hyperintensities (WMH) with a more uniform distribution throughout the brain irrespective of clinical neurologic decompression sickness history. Methods: We evaluated imaging findings in 102 U-2 pilots and 91 controls matched for age, health, and education levels. Three-dimensional, T2-weighted, high-resolution (1-mm isotropic) imaging data were collected using fluid-attenuated inversion recovery sequence on a 3-tesla MRI scanner. Whole-brain and regional WMH volume and number were compared between groups using a 2-tailed Wilcoxon rank sum test. Results: U-2 pilots demonstrated an increase in volume (394%; p = 0.004) and number (295%; p < 0.001) of WMH. Analysis of regional distribution demonstrated WMH more uniformly distributed throughout the brain in U-2 pilots compared with mainly frontal distribution in controls. Conclusion: Pilots with occupational exposure to hypobaria showed a significant increase in WMH lesion volume and number. Unlike the healthy controls with predominantly WMH in the frontal white matter, WMH in pilots were more uniformly distributed throughout the brain. This is consistent with our hypothesized pattern of damage produced by interaction between microemboli and cerebral tissue, leading to thrombosis, coagulation, inflammation, and/or activation of innate immune response, although further studies will be necessary to clarify the pathologic mechanisms responsible. PMID:23960192

RApid Primary care Initiation of Drug treatment for Transient Ischaemic Attack (RAPID−TIA): study protocol for a pilot randomised controlled trial

PubMed Central

2013-01-01

Background People who have a transient ischaemic attack (TIA) or minor stroke are at high risk of a recurrent stroke, particularly in the first week after the event. Early initiation of secondary prevention drugs is associated with an 80% reduction in risk of stroke recurrence. This raises the question as to whether these drugs should be given before being seen by a specialist – that is, in primary care or in the emergency department. The aims of the RAPID-TIA pilot trial are to determine the feasibility of a randomised controlled trial, to analyse cost effectiveness and to ask: Should general practitioners and emergency doctors (primary care physicians) initiate secondary preventative measures in addition to aspirin in people they see with suspected TIA or minor stroke at the time of referral to a specialist? Methods/Design This is a pilot randomised controlled trial with a sub-study of accuracy of primary care physician diagnosis of TIA. In the pilot trial, we aim to recruit 100 patients from 30 general practices (including out-of-hours general practice centres) and 1 emergency department whom the primary care physician diagnoses with TIA or minor stroke and randomly assign them to usual care (that is, initiation of aspirin and referral to a TIA clinic) or usual care plus additional early initiation of secondary prevention drugs (a blood-pressure lowering protocol, simvastatin 40 mg and dipyridamole 200 mg m/r bd). The primary outcome of the main study will be the number of strokes at 90 days. The diagnostic accuracy sub-study will include these 100 patients and an additional 70 patients in whom the primary care physician thinks the diagnosis of TIA is possible, rather than probable. For the pilot trial, we will report recruitment rate, follow-up rate, a preliminary estimate of the primary event rate and occurrence of any adverse events. For the diagnostic study, we will calculate sensitivity and specificity of primary care physician diagnosis using the final TIA clinic diagnosis as the reference standard. Discussion This pilot study will be used to estimate key parameters that are needed to design the main study and to estimate the accuracy of primary care diagnosis of TIA. The planned follow-on trial will have important implications for the initial management of people with suspected TIA. Trial registration ISRCTN62019087 PMID:23819476

Proton pump inhibitors and vascular function: A prospective cross-over pilot study.

PubMed

Ghebremariam, Yohannes T; Cooke, John P; Khan, Fouzia; Thakker, Rahul N; Chang, Peter; Shah, Nigam H; Nead, Kevin T; Leeper, Nicholas J

2015-08-01

Proton pump inhibitors (PPIs) are commonly used drugs for the treatment of gastric reflux. Recent retrospective cohorts and large database studies have raised concern that the use of PPIs is associated with increased cardiovascular (CV) risk. However, there is no prospective clinical study evaluating whether the use of PPIs directly causes CV harm. We conducted a controlled, open-label, cross-over pilot study among 21 adults aged 18 and older who are healthy (n=11) or have established clinical cardiovascular disease (n=10). Study subjects were assigned to receive a PPI (Prevacid; 30 mg) or a placebo pill once daily for 4 weeks. After a 2-week washout period, participants were crossed over to receive the alternate treatment for the ensuing 4 weeks. Subjects underwent evaluation of vascular function (by the EndoPAT technique) and had plasma levels of asymmetric dimethylarginine (ADMA, an endogenous inhibitor of endothelial function previously implicated in PPI-mediated risk) measured prior to and after each treatment interval. We observed a marginal inverse correlation between the EndoPAT score and plasma levels of ADMA (r = -0.364). Subjects experienced a greater worsening in plasma ADMA levels while on PPI than on placebo, and this trend was more pronounced amongst those subjects with a history of vascular disease. However, these trends did not reach statistical significance, and PPI use was also not associated with an impairment in flow-mediated vasodilation during the course of this study. In conclusion, in this open-label, cross-over pilot study conducted among healthy subjects and coronary disease patients, PPI use did not significantly influence vascular endothelial function. Larger, long-term and blinded trials are needed to mechanistically explain the correlation between PPI use and adverse clinical outcomes, which has recently been reported in retrospective cohort studies. © The Author(s) 2015.

Eight-step method to build the clinical content of an evidence-based care pathway: the case for COPD exacerbation

PubMed Central

2012-01-01

Background Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Methods The clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway. Results A set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients. Conclusions The set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways. PMID:23190552

Advanced practice physiotherapy-led triage in Irish orthopaedic and rheumatology services: national data audit.

PubMed

Fennelly, Orna; Blake, Catherine; FitzGerald, Oliver; Breen, Roisin; Ashton, Jennifer; Brennan, Aisling; Caffrey, Aoife; Desmeules, François; Cunningham, Caitriona

2018-06-01

Many people with musculoskeletal (MSK) disorders wait several months or years for Consultant Doctor appointments, despite often not requiring medical or surgical interventions. To allow earlier patient access to orthopaedic and rheumatology services in Ireland, Advanced Practice Physiotherapists (APPs) were introduced at 16 major acute hospitals. This study performed the first national evaluation of APP triage services. Throughout 2014, APPs (n = 22) entered clinical data on a national database. Analysis of these data using descriptive statistics determined patient wait times, Consultant Doctor involvement in clinical decisions, and patient clinical outcomes. Chi square tests were used to compare patient clinical outcomes across orthopaedic and rheumatology clinics. A pilot study at one site identified re-referral rates to orthopaedic/rheumatology services of patients managed by the APPs. In one year, 13,981 new patients accessed specialist orthopaedic and rheumatology consultations via the APP. Median wait time for an appointment was 5.6 months. Patients most commonly presented with knee (23%), lower back (22%) and shoulder (15%) disorders. APPs made autonomous clinical decisions regarding patient management at 77% of appointments, and managed patient care pathways without onward referral to Consultant Doctors in more than 80% of cases. Other onward clinical pathways recommended by APPs were: physiotherapy referrals (42%); clinical investigations (29%); injections administered (4%); and surgical listing (2%). Of those managed by the APP, the pilot study identified that only 6.5% of patients were re-referred within one year. This national evaluation of APP services demonstrated that the majority of patients assessed by an APP did not require onward referral for a Consultant Doctor appointment. Therefore, patients gained earlier access to orthopaedic and rheumatology consultations in secondary care, with most patients conservatively managed.

PHARMacy-based interdisciplinary program for patients with Chronic Heart Failure (PHARM-CHF): rationale and design of a randomized controlled trial, and results of the pilot study.

PubMed

Laufs, Ulrich; Griese-Mammen, Nina; Krueger, Katrin; Wachter, Angelika; Anker, Stefan D; Koehler, Friedrich; Rettig-Ewen, Volker; Botermann, Lea; Strauch, Dorothea; Trenk, Dietmar; Böhm, Michael; Schulz, Martin

2018-05-30

We report the rationale and design of a community PHARMacy-based prospective randomized controlled interdisciplinary study for ambulatory patients with Chronic Heart Failure (PHARM-CHF) and results of its pilot study. The pilot study randomized 50 patients to a pharmacy-based intervention or usual care for 12 months. It demonstrated the feasibility of the design and showed reduced systolic blood pressure in the intervention group as indicator for improved medication adherence. The main study will randomize patients ≥60 years on stable pharmacotherapy including at least one diuretic and a history of heart failure hospitalization within 12 months. The intervention group will receive a medication review at baseline followed by regular dose dispensing of the medication, counselling regarding medication use and symptoms of heart failure. The control patients are unknown to the pharmacy and receive usual care. The primary efficacy endpoint is medication adherence, pre-specified as a significant difference of the proportion of days covered between the intervention and control group within 365 days following randomization using pharmacy claims data for three CHF medications (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, beta-blockers, and mineralocorticoid receptor antagonists). The primary composite safety endpoint is days lost due to blindly adjudicated unplanned cardiovascular hospitalizations or death. Overall, 248 patients shall be randomized. The minimum follow-up is 12 months with an expected mean of 24 months. Based on the feasibility demonstrated in the pilot study, the randomized PHARM-CHF trial will test whether an interdisciplinary pharmacy-based intervention can safely improve medication adherence and will estimate the potential impact on clinical endpoints. ClinicalTrials.gov Identifier: NCT01692119. © 2018 The Authors. European Journal of Heart Failure © 2018 European Society of Cardiology.

GM1 ganglioside in Parkinson's disease: Pilot study of effects on dopamine transporter binding.

PubMed

Schneider, Jay S; Cambi, Franca; Gollomp, Stephen M; Kuwabara, Hiroto; Brašić, James R; Leiby, Benjamin; Sendek, Stephanie; Wong, Dean F

2015-09-15

GM1 ganglioside has been suggested as a treatment for Parkinson's disease (PD), potentially having symptomatic and disease modifying effects. The current pilot imaging study was performed to examine effects of GM1 on dopamine transporter binding, as a surrogate measure of disease progression, studied longitudinally. Positron emission tomography (PET) imaging data were obtained from a subset of subjects enrolled in a delayed start clinical trial of GM1 in PD [1]: 15 Early-start (ES) subjects, 14 Delayed-start (DS) subjects, and 11 Comparison (standard-of-care) subjects. Treatment subjects were studied over a 2.5 year period while Comparison subjects were studied over 2 years. Dynamic PET scans were performed over 90 min following injection of [(11)C]methylphenidate. Regional values of binding potential (BPND) were analyzed for several striatal volumes of interest. Clinical results for this subset of subjects were similar to those previously reported for the larger study group. ES subjects showed early symptomatic improvement and slow symptom progression over the study period. DS and Comparison subjects were initially on the same symptom progression trajectory but diverged once DS subjects received GM1 treatment. Imaging results showed significant slowing of BPND loss in several striatal regions in GM1-treated subjects and in some cases, an increased BPND in some striatal regions was detected after GM1 use. Results of this pilot imaging study provide additional data to suggest a potential disease modifying effect of GM1 on PD. These results need to be confirmed in a larger number of subjects. Copyright © 2015 Elsevier B.V. All rights reserved.

Pilot clinical application of an adaptive robotic system for young children with autism.

PubMed

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

2014-07-01

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 group of preschool children with autism spectrum disorders (n = 6) and a control group (n = 6). Children in both groups spent more time looking at the humanoid robot and were able to achieve a high level of accuracy across trials. However, across groups, children required higher levels of prompting to successfully orient within robot-administered trials. The results highlight both the potential benefits of closed-loop adaptive robotic systems as well as current limitations of existing humanoid-robotic platforms. © The Author(s) 2013.

An open-label six-month extension study to investigate the safety and efficacy of an extract of Artemisia annua for managing pain, stiffness and functional limitation associated with osteoarthritis of the hip and knee.

PubMed

Hunt, Sheena; Stebbings, Simon; McNamara, Debra

2016-10-28

This six-month single-centre open-label extension study, conducted at the University of Otago, Dunedin, follows from a previously published 12-week pilot double-blind randomised placebo-controlled study of dietary supplement, Arthrem® (ART) in patients with osteoarthritis (OA) of the hip or knee. The pilot double-blind study showed that treatment with ART 150 mg twice-daily was associated with clinically relevant pain reduction. The extension study aims were to assess longer-term safety and efficacy during six months' treatment following the pilot trial. Patients who completed the pilot double-blind study had the option to continue on open-label treatment with ART for a further six months. Safety was assessed by adverse event monitoring and laboratory tests at three and six months. Efficacy was assessed at three and six months using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC®). Thirty-four patients entered the optional extension and 28 completed six months' treatment. ART was well tolerated when taken for up to nine months. Improvements in WOMAC® efficacy parameters reported in the double-blind phase of the study were maintained over six months. ART appears to be a safe and effective alternative for managing the symptoms of OA over an extended period.

Validity and Reliability of the Clinical Competency Evaluation Instrument for Use among Physiotherapy Students: Pilot study.

PubMed

Muhamad, Zailani; Ramli, Ayiesah; Amat, Salleh

2015-05-01

The aim of this study was to determine the content validity, internal consistency, test-retest reliability and inter-rater reliability of the Clinical Competency Evaluation Instrument (CCEVI) in assessing the clinical performance of physiotherapy students. This study was carried out between June and September 2013 at University Kebangsaan Malaysia (UKM), Kuala Lumpur, Malaysia. A panel of 10 experts were identified to establish content validity by evaluating and rating each of the items used in the CCEVI with regards to their relevance in measuring students' clinical competency. A total of 50 UKM undergraduate physiotherapy students were assessed throughout their clinical placement to determine the construct validity of these items. The instrument's reliability was determined through a cross-sectional study involving a clinical performance assessment of 14 final-year undergraduate physiotherapy students. The content validity index of the entire CCEVI was 0.91, while the proportion of agreement on the content validity indices ranged from 0.83-1.00. The CCEVI construct validity was established with factor loading of ≥0.6, while internal consistency (Cronbach's alpha) overall was 0.97. Test-retest reliability of the CCEVI was confirmed with a Pearson's correlation range of 0.91-0.97 and an intraclass coefficient correlation range of 0.95-0.98. Inter-rater reliability of the CCEVI domains ranged from 0.59 to 0.97 on initial and subsequent assessments. This pilot study confirmed the content validity of the CCEVI. It showed high internal consistency, thereby providing evidence that the CCEVI has moderate to excellent inter-rater reliability. However, additional refinement in the wording of the CCEVI items, particularly in the domains of safety and documentation, is recommended to further improve the validity and reliability of the instrument.

The New Nitinol Conformable Self-Expandable Metal Stents for Malignant Colonic Obstruction: A Pilot Experience as Bridge to Surgery Treatment

PubMed Central

2014-01-01

Introduction. Self-expandable metal stents (SEMS) are a nonsurgical option for treatment of malignant colorectal obstruction also as a bridge to surgery approach. The new nitinol conformable stent has improved clinical outcomes in these kinds of patients. We report a pilot experience with nitinol conformable SEMS placement as bridge to surgery treatment in patients with colorectal obstruction. Materials and Methods. Between April and August 2012, we collected data on colonic nitinol conformable SEMS placement in a cohort of consecutive symptomatic patients, with malignant colorectal obstruction, who were treated as a bridge to surgery. Technical success, clinical success, and adverse events were recorded. Results. Ten patients (7 male (70%)), with a mean age of 69.2 ± 10.1, were evaluated. The mean length of the stenosis was 3.6 ± 0.6 cm. Five patients (50%) were treated on an emergency basis. The median time from stent placement to surgery was 16 days (interquartile range 7–21). Technical and clinical success was achieved in all patients with a significant early improvement of symptoms. No adverse events due to the SEMS placement were observed. Conclusion. This pilot study confirmed the important role of nitinol conformable SEMS as a bridge to surgery option in the treatment of symptomatic malignant colorectal obstruction. PMID:24526914

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

PubMed

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

2013-10-14

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

Gait retraining versus foot orthoses for patellofemoral pain: a pilot randomised clinical trial.

PubMed

Bonacci, Jason; Hall, Michelle; Saunders, Natalie; Vicenzino, Bill

2018-05-01

To determine the feasibility of a clinical trial that compares a 6-week, physiotherapist-guided gait retraining program with a foot orthoses intervention in runners with patellofemoral pain. Pilot randomised controlled trial. Runners aged 18-40 years with clinically diagnosed patellofemoral pain were randomly allocated to either a 6-week gait retraining intervention of increasing cadence and use of a minimalist shoe or prefabricated foot orthoses. Outcomes at baseline and 12-weeks included recruitment, retention, adherence, adverse events, global improvement, anterior knee pain scale, worst and average pain on a 100mm visual analogue scale. Of the 16 randomised participants, two withdrew prior to commencing treatment due to non-trial related matters (n=1 from each group) and 14 completed the pilot trial. Minor calf muscle soreness was reported by 3 participants in the gait retraining group while no adverse events were reported in the foot orthoses group. There were no deviations from the treatment protocols. There was a large between-group difference favouring gait retraining at 12-weeks in the anterior knee pain scale and the worst pain in the past week, which was reflected in the number needed-to-treat of 2. This study supports the feasibility of a trial comparing gait retraining with foot orthoses and provides point estimates of effect that informs the design and planning of a larger clinical trial. It appears that a 6-week gait retraining program has a clinically meaningful effect on runners with patellofemoral pain when compared to an evidence-based treatment of foot orthoses. Copyright © 2017 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

Developing Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT): protocol for a pilot randomized controlled trial.

PubMed

Watson, Dennis P; Ray, Bradley; Robison, Lisa; Xu, Huiping; Edwards, Rhiannon; Salyers, Michelle P; Hill, James; Shue, Sarah

2017-01-01

There is a lack of evidence-based substance use disorder treatment and services targeting returning inmates. Substance Use Programming for Person-Oriented Recovery and Treatment (SUPPORT) is a community-driven, recovery-oriented approach to substance abuse care which has the potential to address this service gap. SUPPORT is modeled after Indiana's Access to Recovery program, which was closed due to lack of federal support despite positive improvements in clients' recovery outcomes. SUPPORT builds on noted limitations of Indiana's Access to Recovery program. The ultimate goal of this project is to establish SUPPORT as an effective and scalable recovery-oriented system of care. A necessary step we must take before launching a large clinical trial is pilot testing the SUPPORT intervention. The pilot will take place at Public Advocates in Community Re-Entry (PACE), nonprofit serving individuals with felony convictions who are located in Marion County, Indiana (Indianapolis). The pilot will follow a basic parallel randomized design to compare clients receiving SUPPORT with clients receiving standard services. A total of 80 clients within 3 months of prison release will be recruited to participate and randomly assigned to one of the two intervention arms. Quantitative measures will be collected at multiple time points to understand SUPPORT's impact on recovery capital and outcomes. We will also collect qualitative data from SUPPORT clients to better understand their program and post-discharge experiences. Successful completion of this pilot will prepare us to conduct a multi-site clinical trial. The ultimate goal of this future work is to develop an evidence-based and scalable approach to treating substance use disorder among persons returning to society after incarceration. ClinicalTrials.gov (Clinical Trials ID: NCT03132753 and Protocol Number: 1511731907). Registered 28 April 2017.

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

Pilot study demonstrating effectiveness of targeted education to improve informed consent understanding in AIDS clinical trials.

PubMed

Sengupta, Sohini; Lo, Bernard; Strauss, Ronald P; Eron, Joseph; Gifford, Allen L

2011-11-01

Assessing and improving informed consent understanding is equally important as obtaining consent from participants in clinical trial research, but developing interventions to target gaps in participants' informed consent understanding remains a challenge. We used a randomized controlled study design to pilot test an educational intervention to improve actual informed consent understanding of new enrollees in the Adult AIDS Clinical Trial Group (AACTG). Questionnaires were administered to 24 enrollees to assess their baseline understanding on eight elements of informed consent associated with AIDS clinical trials. Enrollees who scored 18/21(85%) or less were randomly assigned to in-person, targeted education (intervention), or delayed education (control). Two follow-up assessments were administered. Repeated measures ANOVA was performed to determine intervention effectiveness in improving actual informed consent understanding over time. Actual understanding improved at the immediate post-intervention time point with a significant score difference of 2.5 when comparing the intervention and delayed groups. In addition, there was a significant score difference of 3.2 when comparing baseline to three-month follow-up for the two groups, suggesting a statistically significant intervention effect to improve actual understanding of the basic elements of informed consent. The findings demonstrated that one-time targeted education can improve actual informed consent understanding one week after the intervention, but retention of these concepts may require periodic monitoring to ensure comprehension throughout the course of a clinical trial.

Patient-centered consumer health social network websites: a pilot study of quality of user-generated health information.

PubMed

Tsai, Christopher C; Tsai, Sarai H; Zeng-Treitler, Qing; Liang, Bryan A

2007-10-11

The quality of user-generated health information on consumer health social networking websites has not been studied. We collected a set of postings related to Diabetes Mellitus Type I from three such sites and classified them based on accuracy, error type, and clinical significance of error. We found 48% of postings contained medical content, and 54% of these were either incomplete or contained errors. About 85% of the incomplete and erroneous messages were potentially clinically significant.

Clinical Investigation Program RCS-MED-300 (R1)

DTIC Science & Technology

1988-09-30

34, pluse one letter to the editor, and one article published (1986 and 1987). . .. ..... .......... .. . • m mmm il lm9 DETAIL SUMMARY SHEET DATE: 1 ...SUMMARY SHEET DATE: 1 October 1988 PROTOCOL #: 87/08 STATUS: Completed TITLE: A Pilot Study on Effect of Nicotine and Cigarette Smoking on...Clinical Immunology, Anaheim, California in March 1988. 29 DETAIL SUMMARY SHEET DATE: 1 October 1988 PROTOCOL #: 87/12 STATUS: Terminated TITLE: Effect

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.

Distant peer-tutoring of clinical skills, using tablets with instructional videos and Skype: A pilot study in the UK and Malaysia.

PubMed

O'Donovan, James; Maruthappu, Mahiben

2015-05-01

To assess the feasibility and impact of using low-cost Android tablets to deliver video tutorials and remote online peer-tutoring for clinical skills between two countries. Nine junior medical students from Malaysia were paired with five senior medical students from the UK, who played the role of peer-tutors. Students from Malaysia were given a low-cost Android tablet from which they could access instructional video tutorials. At the end of each week, the peer-tutors would observe their peer-learners as they performed a clinical examination. Tutors would then provide individual feedback using a videoconferencing tool. Outcomes were assessed using Observed Structured Clinical Examination (OSCE) scores, post-study questionnaires and semi-structured interviews with participants. Peer-learners reported an increased confidence in clinical examination of 8.4 (±1.0) on a 10-point scale and all nine said they would recommend the scheme to their peers. Both peer-tutors and peer-learners were able to establish a strong rapport over video, rating it as 8.4 (±0.6) and 8.4 (±0.9), respectively. Peer-learners' rated the sound and video quality of the tablet as 7.0 (±1.1) but were less satisfied with the screen resolution of the tablet, rating this as 4.0 (±1.5). This preliminary pilot study presents an innovative, low cost approach to international medical education with significant potential for future development.

Clinical predictors of dengue fever co-infected with leptospirosis among patients admitted for dengue fever - a pilot study.

PubMed

Suppiah, Jeyanthi; Chan, Shie-Yien; Ng, Min-Wern; Khaw, Yam-Sim; Ching, Siew-Mooi; Mat-Nor, Lailatul Akmar; Ahmad-Najimudin, Naematul Ain; Chee, Hui-Yee

2017-06-28

Dengue and leptospirosis infections are currently two major endemics in Malaysia. Owing to the overlapping clinical symptoms between both the diseases, frequent misdiagnosis and confusion of treatment occurs. As a solution, the present work initiated a pilot study to investigate the incidence related to co-infection of leptospirosis among dengue patients. This enables the identification of more parameters to predict the occurrence of co-infection. Two hundred sixty eight serum specimens collected from patients that were diagnosed for dengue fever were confirmed for dengue virus serotyping by real-time polymerase chain reaction. Clinical, laboratory and demographic data were extracted from the hospital database to identify patients with confirmed leptospirosis infection among the dengue patients. Thus, frequency of co-infection was calculated and association of the dataset with dengue-leptospirosis co-infection was statistically determined. The frequency of dengue co-infection with leptospirosis was 4.1%. Male has higher preponderance of developing the co-infection and end result of shock as clinical symptom is more likely present among co-infected cases. It is also noteworthy that, DENV 1 is the common dengue serotype among all cases identified as dengue-leptospirosis co-infection in this study. The increasing incidence of leptospirosis among dengue infected patients has posed the need to precisely identify the presence of co-infection for the betterment of treatment without mistakenly ruling out either one of them. Thus, anticipating the possible clinical symptoms and laboratory results of dengue-leptospirosis co-infection is essential.

Scaling Down to Scale Up: A Health Economic Analysis of Integrating Point-of-Care Syphilis Testing into Antenatal Care in Zambia during Pilot and National Rollout Implementation

PubMed Central

Ncube, Alexander Tshaka; Sweeney, Sedona; Fleischer, Colette; Mumba, Grace Tembo; Gill, Michelle M.; Strasser, Susan; Peeling, Rosanna W.; Terris-Prestholt, Fern

2015-01-01

Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST) can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, antenatal registers, clinic staff interviews, and facility observations, with the aim of assessing the cost and quality implications of scaling up a successful pilot into a national rollout. Start-up, capital, and recurrent cost inputs were collected, including costs of extensive supervision and quality monitoring during the pilot. Costs were analysed from a provider’s perspective, incremental to existing antenatal services. Total and unit costs were calculated and a multivariate sensitivity analysis was performed. Our accompanying qualitative study by Ansbro et al. (2015) elucidated quality assurance and supervisory system challenges experienced during rollout, which helped explain key cost drivers. The average unit cost per woman screened during rollout ($11.16) was more than triple the pilot unit cost ($3.19). While quality assurance costs were much lower during rollout, the increased unit costs can be attributed to several factors, including higher RST prices and lower RST coverage during rollout, which reduced economies of scale. Pilot and rollout cost drivers differed due to implementation decisions related to training, supervision, and quality assurance. This study explored the cost of integrating RST into antenatal care in pilot and national rollout settings, and highlighted important differences in costs that may be observed when moving from pilot to scale-up. PMID:25970443

Scaling Down to Scale Up: A Health Economic Analysis of Integrating Point-of-Care Syphilis Testing into Antenatal Care in Zambia during Pilot and National Rollout Implementation.

PubMed

Shelley, Katharine D; Ansbro, Éimhín M; Ncube, Alexander Tshaka; Sweeney, Sedona; Fleischer, Colette; Tembo Mumba, Grace; Gill, Michelle M; Strasser, Susan; Peeling, Rosanna W; Terris-Prestholt, Fern

2015-01-01

Maternal syphilis results in an estimated 500,000 stillbirths and neonatal deaths annually in Sub-Saharan Africa. Despite the existence of national guidelines for antenatal syphilis screening, syphilis testing is often limited by inadequate laboratory and staff services. Recent availability of inexpensive rapid point-of-care syphilis tests (RST) can improve access to antenatal syphilis screening. A 2010 pilot in Zambia explored the feasibility of integrating RST within prevention of mother-to-child-transmission of HIV services. Following successful demonstration, the Zambian Ministry of Health adopted RSTs into national policy in 2011. Cost data from the pilot and 2012 preliminary national rollout were extracted from project records, antenatal registers, clinic staff interviews, and facility observations, with the aim of assessing the cost and quality implications of scaling up a successful pilot into a national rollout. Start-up, capital, and recurrent cost inputs were collected, including costs of extensive supervision and quality monitoring during the pilot. Costs were analysed from a provider's perspective, incremental to existing antenatal services. Total and unit costs were calculated and a multivariate sensitivity analysis was performed. Our accompanying qualitative study by Ansbro et al. (2015) elucidated quality assurance and supervisory system challenges experienced during rollout, which helped explain key cost drivers. The average unit cost per woman screened during rollout ($11.16) was more than triple the pilot unit cost ($3.19). While quality assurance costs were much lower during rollout, the increased unit costs can be attributed to several factors, including higher RST prices and lower RST coverage during rollout, which reduced economies of scale. Pilot and rollout cost drivers differed due to implementation decisions related to training, supervision, and quality assurance. This study explored the cost of integrating RST into antenatal care in pilot and national rollout settings, and highlighted important differences in costs that may be observed when moving from pilot to scale-up.

Developing and piloting an expert system for better routine voluntary HIV counseling and testing in China: preliminary results and lessons.

PubMed

Chai, Jing; Wang, DeBin; Zhou, Meng; Xu, WangQuan; Liang, Guojun; Shen, Yi Fang

2012-01-01

This study aims at developing and testing a pragmatic expert system for HIV voluntary counseling (VCT-ES) that leverages best practices. The VCT-ES was developed via evolutionary prototyping and piloted in 10 voluntary HIV counseling and testing (VCT) clinics from Anhui and Beijing representative of prefecture and county level VCT clinics in China. All counselors with the clinics and the clients to the clinics within selected two weeks at baseline and the end of study were invited to participate. Assessment measures included essential counseling procedures (ECPs); clients' satisfaction, knowledge, and behavior efficacy. VCT-ES was developed which tries to model and facilitate standard VCT operation procedures and best practices. One hundred and eighty-two (96 at baseline vs. 86 after intervention) cases recordings, 172 (96 vs. 76) client questionnaires, 10 counselor, and 2 expert rating instruments were collected; and 17 clients and 8 counselors participated in qualitative interviews. VCT-ES increased delivery of ECPs from 18.94% to 66.39% on average; increased clients' knowledge from 40.51% to 86.34% and self-efficacy by 22.42%. The VCT-ES applications listed were rated 9.1 on average (maximum = 10). The VCT-ES could be an easy and effective solution to better routine VCT and merits further research.

Development and Pilot Testing of a Decision Aid for Genomic Research Participants Notified of Clinically Actionable Research Findings for Cancer Risk.

PubMed

Willis, Amanda M; Smith, Sian K; Meiser, Bettina; Ballinger, Mandy L; Thomas, David M; Tattersall, Martin; Young, Mary-Anne

2018-02-17

Germline genomic testing is increasingly used in research to identify genetic causes of disease, including cancer. However, there is evidence that individuals who are notified of clinically actionable research findings have difficulty making informed decisions regarding uptake of genetic counseling for these findings. This study aimed to produce and pilot test a decision aid to assist participants in genomic research studies who are notified of clinically actionable research findings to make informed choices regarding uptake of genetic counseling. Development was guided by published literature, the International Patient Decision Aid Standards, and the expertise of a steering committee of clinicians, researchers, and consumers. Decision aid acceptability was assessed by self-report questionnaire. All 19 participants stated that the decision aid was easy to read, clearly presented, increased their understanding of the implications of taking up research findings, and would be helpful in decision-making. While low to moderate levels of distress/worry were reported after reading the booklet, a majority of participants also reported feeling reassured. All participants would recommend the booklet to others considering uptake of clinically actionable research findings. Results indicate the decision aid is acceptable to the target audience, with potential as a useful decision support tool for genomic research participants.

Kenyan medical student and consultant experiences in a pilot decentralized training program at the University of Nairobi.

PubMed

Kibore, Minnie W; Daniels, Joseph A; Child, Mara J; Nduati, Ruth; Njiri, Francis J; Kinuthia, Raphael M; O'Malley, Gabrielle; John-Stewart, Grace; Kiarie, James; Farquhar, Carey

2014-01-01

Over the past decade, the University of Nairobi (UoN) has increased the number of enrolled medical students threefold in response to the growing need for more doctors. This has resulted in a congested clinical training environment and limited opportunities for students to practice clinical skills at the tertiary teaching facility. To enhance the clinical experience, the UoN Medical Education Partnership Initiative Program Undertook training of medical students in non-tertiary hospitals around the country under the mentorship of consultant preceptors at these hospitals. This study focused on the evaluation of the pilot decentralized training rotation. The decentralized training program was piloted in October 2011 with 29 fourth-year medical students at four public hospitals for a 7-week rotation. We evaluated student and consultant experiences using a series of focus group discussions. A three-person team developed the codes for the focus groups and then individually and anonymously coded the transcripts. The team's findings were triangulated to confirm major themes. Before the rotation, the students expressed the motivation to gain more clinical experience as they felt they lacked adequate opportunity to exercise clinical skills at the tertiary referral hospital. By the end of the rotation, the students felt they had been actively involved in patient care, had gained clinical skills and had learned to navigate socio-cultural challenges in patient care. They further expressed their wish to return to those hospitals for future practice. The consultants expressed their motivation to teach and mentor students and acknowledged that the academic interaction had positively impacted on patient care. The decentralized training enhanced students' learning by providing opportunities for clinical and community experiences and has demonstrated how practicing medical consultants can be engaged as preceptors in students learning. This training may also increase students' ability and willingness to work in rural and underserved areas.

Practicing evidence based medicine at the bedside: a randomized controlled pilot study in undergraduate medical students assessing the practicality of tablets, smartphones, and computers in clinical life.

PubMed

Friederichs, Hendrik; Marschall, Bernhard; Weissenstein, Anne

2014-12-05

Practicing evidence-based medicine is an important aspect of providing good medical care. Accessing external information through literature searches on computer-based systems can effectively achieve integration in clinical care. We conducted a pilot study using smartphones, tablets, and stationary computers as search devices at the bedside. The objective was to determine possible differences between the various devices and assess students' internet use habits. In a randomized controlled pilot study, 120 students were divided in three groups. One control group solved clinical problems on a computer and two intervention groups used mobile devices at the bedside. In a questionnaire, students were asked to report their internet use habits as well as their satisfaction with their respective search tool using a 5-point Likert scale. Of 120 surveys, 94 (78.3%) complete data sets were analyzed. The mobility of the tablet (3.90) and the smartphone (4.39) was seen as a significant advantage over the computer (2.38, p < .001). However, for performing an effective literature search at the bedside, the computer (3.22) was rated superior to both tablet computers (2.13) and smartphones (1.68). No significant differences were detected between tablets and smartphones except satisfaction with screen size (tablet 4.10, smartphone 2.00, p < .001). Using a mobile device at the bedside to perform an extensive search is not suitable for students who prefer using computers. However, mobility is regarded as a substantial advantage, and therefore future applications might facilitate quick and simple searches at the bedside.

Vitamin K Acupuncture Point Injection for Severe Primary Dysmenorrhea: An International Pilot Study

PubMed Central

Wang, Li; Zhao, Wenjie; Yu, Jin; Cardini, Francesco; Forcella, Emanuela; Regalia, Anna Laura; Wade, Christine

2004-01-01

Context Vitamin K acupuncture point injection, a menstrual pain treatment derived from traditional Chinese medicine, has been a standard treatment in some hospitals in China since the 1980s. Objectives To investigate the effects of vitamin K acupuncture point injection on menstrual pain in young women aged 14 to 25 from different countries and cultural backgrounds who have had unmitigated severe primary dysmenorrhea for 6 months or more Design Prospective, observational, clinical pilot study Settings One site in China (a hospital outpatient clinic in Shanghai) and 2 sites in Italy (a hospital clinic in Milan and a private gynecology practice in Verona) Interventions All subjects were treated with bilateral acupuncture point injection of vitamin K on the first or second day of menstrual pain. Vitamin K3 was used in China and vitamin K4 in Italy. Main Outcome Measures Pain intensity, total duration, and average intensity of menstrual distress, hours in bed, normal daily activity restrictions, and numbers of analgesic tablets taken to relieve pain were recorded before the treatment and for 4 subsequent menstrual cycles. Results Noticeable pain relief was observed 2 minutes after treatment, and subsequent pain reduction occurred at 30 minutes (P < .001). Subjects reported significantly fewer daily life restrictions, fewer hours in bed, less consumption of analgesic tablets, and lower scores of menstrual pain duration and intensity (P < .001). There were no adverse events. Some women experienced mild, self-limited pain at the injection site. Conclusion Acupuncture point injection with vitamin K alleviated acute menstrual pain, and relief extended through the nontreatment follow-up cycles in this uncontrolled pilot study conducted in 2 countries. Further investigation employing controlled experimental designs is warranted. PMID:15775872

Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

PubMed

Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria

2018-04-01

This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p < 0.01 and p = 0.03, respectively), while the change among the gabapentin-only group was nonsignificant. The OMM only group was the only group to experience a significant decline in CGI scale (p < 0.01). No statistically significant changes were observed with the FIQ or number of tender points. No differences across groups were statistically significant. This is to be expected in a feasibility study with a small sample size. This pilot study suggests that OMM treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

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…

Increase in Teachers' Knowledge about ADHD after a Week-Long Training Program: A Pilot Study

ERIC Educational Resources Information Center

Syed, Ehsan Ullah; Hussein, Sajida Abdul

2010-01-01

Objectives: ADHD affects 3% to 5% of school-age children. Clinical and community based epidemiological studies in Pakistan have shown a high prevalence of ADHD among school going children. A thorough review of literature shows that no studies of teachers' training programs regarding ADHD have been published in Pakistani research literature. The…

F30. SMARTPHONE APPLICATION “ROBIN”: FEASIBILITY, ENGAGEMENT AND SATISFACTION OF A SMARTPHONE APPLICATION APPROACH TO SUPPORT TREATMENT OF (ATTENUATED) PSYCHOTIC SYMPTOMS IN ADOLESCENTS

PubMed Central

Traber-Walker, Nina; Metzler, Sibylle; Gerstenberg, Miriam; Walitza, Susanne; Franscini, Maurizia

2018-01-01

Abstract Background There is increasing interest in using mobile technologies such as smartphones application in mental health care. First research results from the use of smartphone applications in the treatment of psychotic disorders are promising. Current analysis showed, that especially young people would be interested in smartphone applications within treatment settings. However, there is a lack of investigations in this population. There is also little known about mobile technologies in the work with attenuated psychotic symptoms. To address these gaps, we developed “Robin”, a specific smartphone application to support the therapy of adolescents with attenuated or full-blown psychotic symptoms. The smartphone application targets medication adherence, real-time symptom assessment and provides help coping with symptoms and stressful situations in daily life. Methods Based on existing literature and our clinical expertise within a specialized outpatient care for adolescents with (attenuated) psychotic symptoms, a first modular version of the app was developed and adapted after first pilot investigations with patients (N=7, Age 14–18) and therapists (N=10). Participants of the pilot investigation completed a questionnaire regarding usability and acceptance of the application. Furthermore, we investigated how the patients used the application in their daily life by analyzing the user data from the application. In September 2017, the development of the smartphone application has been finalized and we have started with a systematic clinical evaluation study for testing the efficiency of the app. The application is only used in combination with psychotherapy in our university hospital for child and adolescent psychiatry. Results The data from our pilot investigation showed, that “Robin” was accepted by clinicians and patients. All clinicians said they would like to use the application to enrich their therapeutic approaches. All patients in the pilot project used the application in their daily life. Especially modules with information about symptoms and coping strategies were frequently used. Since September 2017, first patients have been included to the systematic evaluation study. In Florence 2018, we will present first data from this study about feasibility, engagement and subjectively perceived benefit of the smartphone application. Discussion The first feedbacks from the pilot investigation were encouraging. The findings were used to improve and adapt the application. Since September 2017, the application is used in psychotherapy and an evaluation study has started. This is one of the first clinical trials to test the efficacy of a specific application developed for adolescents with psychotic and with attenuated psychotic symptoms.

The effects of "The Work" meditation (Byron Katie) on psychological symptoms and quality of life--a pilot clinical study.

PubMed

Smernoff, Eric; Mitnik, Inbal; Kolodner, Ken; Lev-Ari, Shahar

2015-01-01

"The Work" is a meditative technique that enables the identification and investigation of thoughts that cause an individual stress and suffering. Its core is comprised of four questions and turnarounds that enable the participant to experience a different interpretation of reality. We assessed the effect of "The Work" meditation on quality of life and psychological symptoms in a non-clinical sample. This study was designed as a single-group pilot clinical trial (open label). Participants (n = 197) enrolled in a nine-day training course ("The School for The Work") and completed a set of self-administered measures on three occasions: before the course (n = 197), after the course (n = 164), and six months after course completion (n = 102). Beck Depression Inventory-II (BDI-II), Subjective Happiness Scale (SHS), Quality of Life Inventory (QOLI), Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16), Outcome Questionnaire 45.2 (OQ-45.2), State-Trait Anger Expression Inventory-2 (STAXI-2), and State-Trait Anxiety Inventory (STAI). A mixed models analysis revealed significant positive changes between baseline compared to the end of the intervention and six-month follow-up in all measures: BDI-II (t = 10.24, P < .0001), SHS (t = -9.07, P <.0001), QOLI (t = -5.69, P < .0001), QIDS-SR16 (t = 9.35, P < .0001), OQ-45.2 (t = 11.74, P < .0001), STAXI-2 (State) (t = 3.69, P = .0003), STAXI-2 (Trait) (t = 7.8, P < .0001), STAI (State) (t = 11.46, P < .0001), and STAI (Trait) (t = 10.75, P < .0001). The promising results of this pilot study warrant randomized clinical trials to validate "The Work" meditation technique as an effective intervention for improvement in psychological state and quality of life in the general population. Copyright © 2015 Elsevier Inc. All rights reserved.

The national DBS brain tissue network pilot study: need for more tissue and more standardization.

PubMed

Vedam-Mai, V; Krock, N; Ullman, M; Foote, K D; Shain, W; Smith, K; Yachnis, A T; Steindler, D; Reynolds, B; Merritt, S; Pagan, F; Marjama-Lyons, J; Hogarth, P; Resnick, A S; Zeilman, P; Okun, M S

2011-08-01

Over 70,000 DBS devices have been implanted worldwide; however, there remains a paucity of well-characterized post-mortem DBS brains available to researchers. We propose that the overall understanding of DBS can be improved through the establishment of a Deep Brain Stimulation-Brain Tissue Network (DBS-BTN), which will further our understanding of DBS and brain function. The objectives of the tissue bank are twofold: (a) to provide a complete (clinical, imaging and pathological) database for DBS brain tissue samples, and (b) to make available DBS tissue samples to researchers, which will help our understanding of disease and underlying brain circuitry. Standard operating procedures for processing DBS brains were developed as part of the pilot project. Complete data files were created for individual patients and included demographic information, clinical information, imaging data, pathology, and DBS lead locations/settings. 19 DBS brains were collected from 11 geographically dispersed centers from across the U.S. The average age at the time of death was 69.3 years (51-92, with a standard deviation or SD of 10.13). The male:female ratio was almost 3:1. Average post-mortem interval from death to brain collection was 10.6 h (SD of 7.17). The DBS targets included: subthalamic nucleus, globus pallidus interna, and ventralis intermedius nucleus of the thalamus. In 16.7% of cases the clinical diagnosis failed to match the pathological diagnosis. We provide neuropathological findings from the cohort, and perilead responses to DBS. One of the most important observations made in this pilot study was the missing data, which was approximately 25% of all available data fields. Preliminary results demonstrated the feasibility and utility of creating a National DBS-BTN resource for the scientific community. We plan to improve our techniques to remedy omitted clinical/research data, and expand the Network to include a larger donor pool. We will enhance sample preparation to facilitate advanced molecular studies and progenitor cell retrieval.

Assisting differential clinical diagnosis of cattle diseases using smartphone-based technology in low resource settings: a pilot study.

PubMed

Beyene, Tariku Jibat; Eshetu, Amanuel; Abdu, Amina; Wondimu, Etenesh; Beyi, Ashenafi Feyisa; Tufa, Takele Beyene; Ibrahim, Sami; Revie, Crawford W

2017-11-09

The recent rise in mobile phone use and increased signal coverage has created opportunities for growth of the mobile Health sector in many low resource settings. This pilot study explores the use of a smartphone-based application, VetAfrica-Ethiopia, in assisting diagnosis of cattle diseases. We used a modified Delphi protocol to select important diseases and Bayesian algorithms to estimate the related disease probabilities based on various clinical signs being present in Ethiopian cattle. A total of 928 cases were diagnosed during the study period across three regions of Ethiopia, around 70% of which were covered by diseases included in VetAfrica-Ethiopia. Parasitic Gastroenteritis (26%), Blackleg (8.5%), Fasciolosis (8.4%), Pasteurellosis (7.4%), Colibacillosis (6.4%), Lumpy skin disease (5.5%) and CBPP (5.0%) were the most commonly occurring diseases. The highest (84%) and lowest (30%) levels of matching between diagnoses made by student practitioners and VetAfrica-Ethiopia were for Babesiosis and Pasteurellosis, respectively. Multiple-variable logistic regression analysis indicated that the putative disease indicated, the practitioner involved, and the level of confidence associated with the prediction made by VetAfrica-Ethiopia were major determinants of the likelihood that a diagnostic match would be obtained. This pilot study demonstrated that the use of such applications can be a valuable means of assisting less experienced animal health professionals in carrying out disease diagnosis which may lead to increased animal productivity through appropriate treatment.

Developing and pilot testing of a tool for "clinicosocial case study" assessment of community medicine residents.

PubMed

Gohel, Manisha; Singh, Uday Shankar; Bhanderi, Dinesh; Phatak, Ajay

2016-01-01

Practical and clinical skills teaching should constitute a core part of the postgraduate curriculum of Community Medicine. The clinicosocial case study is a method to enhance learners' skills but there is no generally accepted organized system of formative assessment and structured feedback to guide students. A new tool based on the principles of mini-Clinical Evaluation Exercise (mini CEX) was developed and pilot tested as a 'clinicosocial case study' assessment of community medicine residents with feedback as a core component. Ten core domains of clinicosocial skills were identified after reviewing the relevant literature and input from local experts in community medicine and medical education. We pilot tested the tool with eight faculty members to assess five residents during clinicosocial case presentations on a variety of topics. Kappa statistic and Bland Altman plots were used to assess agreement between faculty members' average assessment scores. Cronbach's alpha was used to test the internal consistency with faculty members as domains. All 95% confidence limits using the Bland-Altman method were within the predetermined limit of 2 points. The overall Kappa between two faculty members was fair ranging from 0.2 to 0.3. Qualitative feedback revealed that both faculty and residents were enthusiastic about the process but faculty suggested further standardization, while residents suggested streamlining of the process. This new assessment tool is available for objective and unbiased assessment of residents through 'clinicosocial case study,' which enriches learning through comprehensive feedback. Further validation in different settings is needed.

76 FR 9789 - Office of Urban Indian Health Programs; Announcement Type: Limited Competition, Continuation...

Federal Register 2010, 2011, 2012, 2013, 2014

2011-02-22

... many cases staffed by volunteers, offering outreach and referral-type services, and maintaining..., for a pilot urban clinic in Rapid City. In 1973, Congress appropriated funds to study the unmet urban Indian health needs in Minneapolis. The findings of this study documented cultural, economic, and access...

Early Language Development in Blind and Severely Visually Impaired Children. Interim Report on Pilot Study.

ERIC Educational Resources Information Center

Moore, Vanessa; McConachie, Helen

This study investigated variables that might be associated with outcome differences in language development of 10 children (ages 10-20 months) with blindness or severe visual impairments, attending a developmental vision clinic in southern England. Subjects' early patterns of expressive language development were examined and related to observed…

Investigating the Efficacy of Practical Skill Teaching: A Pilot-Study Comparing Three Educational Methods

ERIC Educational Resources Information Center

Maloney, Stephen; Storr, Michael; Paynter, Sophie; Morgan, Prue; Ilic, Dragan

2013-01-01

Effective education of practical skills can alter clinician behaviour, positively influence patient outcomes, and reduce the risk of patient harm. This study compares the efficacy of two innovative practical skill teaching methods, against a traditional teaching method. Year three pre-clinical physiotherapy students consented to participate in a…

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.

Medical student, nursing student, and non-health care respondents' implicit attitudes toward doctors and patients: Development and a pilot study of a new implicit attitudes test (IAT).

PubMed

Schwartz, Alan; Mazouni, Abdelhamid

2017-01-01

Medical educators have been concerned that medical students may decline in empathy for patients during the course of their training, based on studies measuring clinical empathy using psychometrically strong self-report measures. Clinical empathy is a complex construct, incorporating attitudes toward patients but also other components, such as professional detachment. Triangulation of extant measures with instruments based on nonreactive methods could provide a better understanding of whether and how physician attitudes toward patients may be changing during training. We sought to develop and pilot-test such a nonreactive method. We develop variations of an implicit association test (IAT) designed to measure attitudes toward physicians and patients based on speed of reaction to images of actors and positive and negative words. In the IATs, the same actors are photographed as doctors, clinic outpatients, hospitalized inpatients, and as a "general public" control. We examine preliminary evidence for their validity by collecting pilot data from internet participants (not involved in the health professions), medical students, and nursing students. Internet participants (n = 314) and nursing students (n = 31) had more negative associations (IAT scores) with doctors than did medical students (n = 89); nursing students and female internet participants had more positive associations with hospitalized patients than did medical students and male internet participants. Medical students' associations with hospitalized patients varied by year of training. This IAT may provide insight into implicit attitudes among those who enter training for the health profession and changes in those attitudes that may be inculcated during that training.

Development and implementation of an objective structured clinical examination to provide formative feedback on communication and interpersonal skills in geriatric training.

PubMed

O'Sullivan, Patricia; Chao, Serena; Russell, Matthew; Levine, Sharon; Fabiny, Anne

2008-09-01

Teaching and assessment of communication and interpersonal skills, one of the American Council for Graduate Medical Education-designated core competencies, is an important but difficult task in the training of physicians. Assessment of trainees offers an opportunity to provide explicit feedback on their skills and encourages learning. This article describes a pilot study in which clinician-educators affiliated with the geriatrics training programs at Beth Israel Deaconess Medical Center and Boston University Medical Center designed and piloted a novel Objective Structured Clinical Examination (OSCE) to assess the communication and interpersonal skills of medical, dental, and geriatric psychiatry fellows. The OSCE consisted of three stations where geriatricians and standardized patients evaluated candidates using specifically designed checklists and an abbreviated version of the Master Interview Rating Scale. Communication skills were assessed through performance of specific "real life" clinical tasks, such as obtaining a medical history, explaining a diagnosis and prognosis, giving therapeutic instructions, and counseling. Interpersonal skills were assessed through the effect of the communication between doctor and standardized patient on fostering trust, relieving anxiety, and establishing a therapeutic relationship. This pilot study demonstrated that the OSCE format of assessment provides a valid means of evaluating the communication and interpersonal skills of interdisciplinary geriatric trainees and provides a valuable forum for formative assessment and feedback. Given that geriatricians and non geriatricians involved in elder care both need communication and interpersonal skills, this novel OSCE can be used for assessment of these skills in trainees in diverse healthcare subspecialties.

Evaluation of a pilot hypertension management programme for Guatemalan adults

PubMed Central

Mendoza Montano, Carlos; Fort, Meredith; deRamirez, Miriam; Cruz, Judith; Ramirez-Zea, Manuel

2016-01-01

Corazón Sano y Feliz is a hypertension management intervention developed to address deficiencies in the management of hypertensive patients in Guatemala. From 2007 to 2009, Corazón Sano y Feliz was pilot-tested in the community of Mixco. Corazón Sano y Feliz comprises a clinical risk assessment and treatment component implemented primarily by nurses, and a health education component implemented by community health workers. To accomplish our secondary objective of determining Corazon Sano y Feliz's potential for change at the patient level, we implemented a one-group pretest-posttest study design to examine changes in clinical measures, knowledge and practices between baseline and the end of the 6-month intervention. Two nurses and one physician set up a hypertension clinic to manage patients according to risk level. Twenty-nine community health workers were trained in CVD risk reduction and health promotion and in turn led six educational sessions for patients. Comparing baseline and 6-month measures, the intervention achieved significant improvements in mean knowledge and behaviour (increase from 54.6 to 59.1 out of a possible 70 points) and significant reductions of mean systolic and diastolic blood pressure (27.2 and 7.7 mmHg), body mass index (from 26.5 to 26.2 kg/m2) and waist circumference (89.6–88.9 cm). In this pilot study we obtained preliminary evidence that this community-oriented hypertension management and health promotion intervention model was feasible and achieved significant reduction in risk factors. If scaled up, this intervention has the potential to substantially reduce CVD burden. PMID:25595280

Developing an Evaluation Tool for Assessing Clinical Ethics Consultation Skills in Simulation Based Education: The ACES Project.

PubMed

Wasson, Katherine; Parsi, Kayhan; McCarthy, Michael; Siddall, Viva Jo; Kuczewski, Mark

2016-06-01

The American Society for Bioethics and Humanities has created a quality attestation (QA) process for clinical ethics consultants; the pilot phase of reviewing portfolios has begun. One aspect of the QA process which is particularly challenging is assessing the interpersonal skills of individual clinical ethics consultants. We propose that using case simulation to evaluate clinical ethics consultants is an approach that can meet this need provided clear standards for assessment are identified. To this end, we developed the Assessing Clinical Ethics Skills (ACES) tool, which identifies and specifies specific behaviors that a clinical ethics consultant should demonstrate in an ethics case simulation. The aim is for the clinical ethics consultant or student to use a videotaped case simulation, along with the ACES tool scored by a trained rater, to demonstrate their competence as part of their QA portfolio. The development and piloting of the tool is described.

Clinical assessment of pitch perception.

PubMed

Vaerenberg, Bart; Pascu, Alexandru; Del Bo, Luca; Schauwers, Karen; De Ceulaer, Geert; Daemers, Kristin; Coene, Martine; Govaerts, Paul J

2011-07-01

The perception of pitch has recently gained attention. At present, clinical audiologic tests to assess this are hardly available. This article reports on the development of a clinical test using harmonic intonation (HI) and disharmonic intonation (DI). Prospective collection of normative data and pilot study in hearing-impaired subjects. Tertiary referral center. Normative data were collected from 90 normal-hearing subjects recruited from 3 different language backgrounds. The pilot study was conducted on 18 hearing-impaired individuals who were selected into 3 pathologic groups: high-frequency hearing loss (HF), low-frequency hearing loss (LF), and cochlear implant users (CI). Normative data collection and exploratory diagnostics by means of the newly constructed HI/DI tests using intonation patterns to find the just noticeable difference (JND) for pitch discrimination in low-frequency harmonic complex sounds presented in a same-different task. JND for pitch discrimination using HI/DI tests in the hearing population and pathologic groups. Normative data are presented in 5 parameter statistics and box-and-whisker plots showing median JNDs of 2 (HI) and 3 Hz (DI). The results on both tests are statistically abnormal in LF and CI subjects, whereas they are not significantly abnormal in the HF group. The HI and DI tests allow the clinical assessment of low-frequency pitch perception. The data obtained in this study define the normal zone for both tests. Preliminary results indicate possible abnormal TFS perception in some hearing-impaired subjects.

Self-Testing of Vision in Age-Related Macula Degeneration: A Longitudinal Pilot Study Using a Smartphone-Based Rarebit Test

PubMed Central

2015-01-01

Purpose. There is a need for efficient self-tests of vision in patients with neovascular age-related macula degeneration. A new tablet/smartphone application aiming to meet this need is described and its performance is assessed in a longitudinal pilot study. Materials and Methods. The new MultiBit Test (MBT) employs segmented digits defined by rarebits, that is, receptive field-size bright dots briefly presented against a dark background. The number of rarebits per digit segment was varied in a cyclic fashion, in preset steps. There were no fixation demands. Twenty-eight patients with neovascular AMD of varying severity were monitored for an average of 30 weeks. Test scores were evaluated on an individual basis, by contrasting observed trends with the clinical status recorded at independently scheduled clinical examinations. Results. Serial plots of MBT results revealed gradual improvement after successful antineovascular treatment. Recurrences were signalled by gradual deteriorations of results. Test results remained stable during clinically stable time intervals. MBT results agreed well with clinical assessments whereas an acuity test performed at chance level. The MBT was well accepted by all subjects. Conclusions. The MBT appears to have a good potential for effective self-testing of vision in AMD and merits large-scale studies. Exploration of MBT performance with other forms of macula conditions may be worthwhile. PMID:26124958

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

The usefulness of school-based syndromic surveillance for detecting malaria epidemics: experiences from a pilot project in Ethiopia.

PubMed

Ashton, Ruth A; Kefyalew, Takele; Batisso, Esey; Awano, Tessema; Kebede, Zelalem; Tesfaye, Gezahegn; Mesele, Tamiru; Chibsa, Sheleme; Reithinger, Richard; Brooker, Simon J

2016-01-09

Syndromic surveillance is a supplementary approach to routine surveillance, using pre-diagnostic and non-clinical surrogate data to identify possible infectious disease outbreaks. To date, syndromic surveillance has primarily been used in high-income countries for diseases such as influenza--however, the approach may also be relevant to resource-poor settings. This study investigated the potential for monitoring school absenteeism and febrile illness, as part of a school-based surveillance system to identify localised malaria epidemics in Ethiopia. Repeated cross-sectional school- and community-based surveys were conducted in six epidemic-prone districts in southern Ethiopia during the 2012 minor malaria transmission season to characterise prospective surrogate and syndromic indicators of malaria burden. Changes in these indicators over the transmission season were compared to standard indicators of malaria (clinical and confirmed cases) at proximal health facilities. Subsequently, two pilot surveillance systems were implemented, each at ten sites throughout the peak transmission season. Indicators piloted were school attendance recorded by teachers, or child-reported recent absenteeism from school and reported febrile illness. Lack of seasonal increase in malaria burden limited the ability to evaluate sensitivity of the piloted syndromic surveillance systems compared to existing surveillance at health facilities. Weekly absenteeism was easily calculated by school staff using existing attendance registers, while syndromic indicators were more challenging to collect weekly from schoolchildren. In this setting, enrolment of school-aged children was found to be low, at 54%. Non-enrolment was associated with low household wealth, lack of parental education, household size, and distance from school. School absenteeism is a plausible simple indicator of unusual health events within a community, such as malaria epidemics, but the sensitivity of an absenteeism-based surveillance system to detect epidemics could not be rigorously evaluated in this study. Further piloting during a demonstrated increase in malaria transmission within a community is recommended.

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.

A qualitative evaluation of a pilot leadership programme for dentists.

PubMed

Walsh, Jonathan; Taylor, Nicholas; Hough, Donna; Brocklehurst, Paul

2015-07-06

The purpose of this paper was to evaluate a pilot training programme run by Health Education North West to promote clinical leadership amongst general dental practitioners (GDPs). New powers and responsibilities for clinicians have caused a fundamental shift in the way that local services are planned and delivered in England. GDPs are being appointed onto the boards of local professional networks (LPNs) to influence the way that services are delivered at a local level. Analogous to clinical commissioning groups in medicine, the role of LPNs is to ensure that GDPs lead change and drive up the quality of service provision. Clinical leadership has been argued to be fundamentally important in these new structures, but has received little attention in the dental literature. Semi-structured interviews and a focus group were held with participants of the pilot to explore their understanding and experience of clinical leadership. These were recorded, transcribed verbatim and underwent thematic analysis. Nineteen codes were identified and organized into four themes: nature of clinical leadership, challenges for clinical leaders in dentistry, Leadership Exploration and Discovery programme evaluation and future direction. The research provides an understanding of how GDPs conceptualise clinical leadership and provides recommendations for future leadership training programmes. This is the first evaluation of a leadership programme for GDPs and so helps address the paucity of evidence in the dental literature.

Pilot clinical trial of a robot-aided neuro-rehabilitation workstation with stroke patients

NASA Astrophysics Data System (ADS)

Krebs, Hermano I.; Hogan, Neville; Aisen, Mindy L.; Volpe, Bruce T.

1996-12-01

This paper summarizes our efforts to apply robotics and automation technology to assist, enhance, quantify, and document neuro-rehabilitation. It reviews a pilot clinical trial involving twenty stroke patients with a prototype robot-aided rehabilitation facility developed at MIT and tested at Burke Rehabilitation Hospital. In particular, we present a few results: (a) on the patient's tolerance of the procedure, (b) whether peripheral manipulation of the impaired limb influences brain recovery, (c) on the development of a robot-aided assessment procedure.

Pilot clinical study of boron neutron capture therapy for recurrent hepatic cancer involving the intra-arterial injection of a (10)BSH-containing WOW emulsion.

PubMed

Yanagie, Hironobu; Higashi, Syushi; Seguchi, Koji; Ikushima, Ichiro; Fujihara, Mituteru; Nonaka, Yasumasa; Oyama, Kazuyuki; Maruyama, Syoji; Hatae, Ryo; Suzuki, Minoru; Masunaga, Shin-ichiro; Kinashi, Tomoko; Sakurai, Yoshinori; Tanaka, Hiroki; Kondo, Natsuko; Narabayashi, Masaru; Kajiyama, Tetsuya; Maruhashi, Akira; Ono, Koji; Nakajima, Jun; Ono, Minoru; Takahashi, Hiroyuki; Eriguchi, Masazumi

2014-06-01

A 63-year-old man with multiple HCC in his left liver lobe was enrolled as the first patient in a pilot study of boron neutron capture therapy (BNCT) involving the selective intra-arterial infusion of a (10)BSH-containing water-in-oil-in-water emulsion ((10)BSH-WOW). The size of the tumorous region remained stable during the 3 months after the BNCT. No adverse effects of the BNCT were observed. The present results show that (10)BSH-WOW can be used as novel intra-arterial boron carriers during BNCT for HCC. Copyright © 2014 Elsevier Ltd. All rights reserved.

Validity of FAA-approved color vision tests for class II and class III aeromedical screening.

DOT National Transportation Integrated Search

1993-09-01

All clinical color vision tests currently used in the medical examination of pilots were studied regarding validity for prediction of performance on practical tests of ability to discriminate the aviation signal colors, red, green, and white given un...

The Qatar Biobank: background and methods.

PubMed

Al Kuwari, Hanan; Al Thani, Asma; Al Marri, Ajayeb; Al Kaabi, Abdulla; Abderrahim, Hadi; Afifi, Nahla; Qafoud, Fatima; Chan, Queenie; Tzoulaki, Ioanna; Downey, Paul; Ward, Heather; Murphy, Neil; Riboli, Elio; Elliott, Paul

2015-12-03

The Qatar Biobank aims to collect extensive lifestyle, clinical, and biological information from up to 60,000 men and women Qatari nationals and long-term residents (individuals living in the country for ≥15 years) aged ≥18 years (approximately one-fifth of all Qatari citizens), to follow up these same individuals over the long term to record any subsequent disease, and hence to study the causes and progression of disease, and disease burden, in the Qatari population. Between the 11(th)-December-2012 and 20(th)-February-2014, 1209 participants were recruited into the pilot study of the Qatar Biobank. At recruitment, extensive phenotype information was collected from each participant, including information/measurements of socio-demographic factors, prevalent health conditions, diet, lifestyle, anthropometry, body composition, bone health, cognitive function, grip strength, retinal imaging, total body dual energy X-ray absorptiometry, and measurements of cardiovascular and respiratory function. Blood, urine, and saliva were collected and stored for future research use. A panel of 66 clinical biomarkers was routinely measured on fresh blood samples in all participants. Rates of recruitment are to be progressively increased in the coming period and the recruitment base widened to achieve a cohort of consented individuals broadly representative of the eligible Qatari population. In addition, it is planned to add additional measures in sub-samples of the cohort, including Magnetic Resonance Imaging (MRI) of the brain, heart and abdomen. The mean time for collection of the extensive phenotypic information and biological samples from each participant at the baseline recruitment visit was 179 min. The 1209 pilot study participants (506 men and 703 women) were aged between 28-80 years (median 39 years); 899 (74.4%) were Qatari nationals and 310 (25.6%) were long-term residents. Approximately two-thirds of pilot participants were educated to graduate level or above. The pilot has proven that recruitment of volunteers into the Qatar Biobank project with intensive baseline measurements of behavioural, physical, and clinical characteristics is well accepted and logistically feasible. Qatar Biobank will provide a powerful resource to investigate the major determinants of ill-health and well-being in Qatar, providing valuable insights into the current and future public health burden that faces the country.

Osteopathy for Endometriosis and Chronic Pelvic Pain - a Pilot Study.

PubMed

Sillem, M; Juhasz-Böss, I; Klausmeier, I; Mechsner, S; Siedentopf, F; Solomayer, E

2016-09-01

Introduction: Pelvic pain is a common problem in gynaecological practice. It is often unclear whether definite causality exists between reported symptoms and objective clinical findings of the female genital tract, and medical or operative treatments do not always achieve long-term resolution of symptoms. Methods: This pilot study investigated 28 patients (age 20-65, median 36.5 years) from a gynaecology practice whose only clinical finding was painful pelvic floor muscle tightness. Following standardised gynaecological and physiotherapist examination, all patients received osteopathic treatment. Pain had been present for a median of 3 years (range 1 month to 20 years). 14 patients had previously confirmed endometriosis. Treatment success was evaluated on consultation with patients in person or in writing. Results: 22 of the 28 participants completed the treatment according to plan. Overall, 17 reported symptom improvement, while 10 of the 14 patients with endometriosis did. Conclusion: Osteopathy is well received by women with painful pelvic floor muscle tightness and appears to be an effective treatment option.

A Pilot Study of a Peer-Group Lifestyle Intervention Enhanced With mHealth Technology and Social Media for Adults With Serious Mental Illness.

PubMed

Aschbrenner, Kelly A; Naslund, John A; Shevenell, Megan; Kinney, Elizabeth; Bartels, Stephen J

2016-06-01

This pilot study examined the preliminary effectiveness of a peer-group lifestyle intervention enhanced with mobile health technology and social media for obese individuals with serious mental illness. Thirty-two participants with a body mass index of 30 or higher received a 24-week intervention designed to facilitate peer support for lifestyle change through experiential learning and use of wearable activity tracking devices, smartphone applications, and Facebook to reinforce physical activity, healthy eating, and group participation between sessions. The primary outcome was weight loss. Secondary measures included fitness and participants' perceptions of peer-group support. Most participants (72%) lost weight, including 28% achieving clinically significant weight loss, and 17% of participants showed clinically significant improvements in cardiovascular fitness. Weight loss was associated with perceived peer-group support. This evaluation demonstrated the preliminary effectiveness of a potentially scalable peer-group lifestyle intervention delivered in community mental health settings for obese individuals with serious mental illness.

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.

RADIOLOGY EDUCATION: A PILOT STUDY TO ASSESS KNOWLEDGE OF MEDICAL STUDENTS REGARDING IMAGING IN TRAUMA.

PubMed

Siddiqui, Saad; Saeed, Muhammad Anwar; Shah, Noreen; Nadeem, Naila

2015-01-01

Trauma remains one of the most frequent presentations in emergency departments. Imaging has established role in setting of acute trauma with ability to identify potentially fatal conditions. Adequate knowledge of health professionals regarding trauma imaging is vital for improved healthcare. In this work we try to assess knowledge of medical students regarding imaging in trauma as well as identify most effective way of imparting radiology education. This cross-sectional pilot study was conducted at Aga Khan University Medical College & Khyber Girls Medical College, to assess knowledge of medical students regarding imaging protocols practiced in initial management of trauma patients. Only 40 & 20% respectively were able to identify radiographs included in trauma series. Very few had knowledge of correct indication for Focused abdominal sonography in trauma. Clinical radiology rotation was reported as best way of learning radiology. Change in curricula & restructuring of clinical radiology rotation structure is needed to improve knowledge regarding Trauma imaging.

Pilot-testing an adverse drug event reporting form prior to its implementation in an electronic health record.

PubMed

Chruscicki, Adam; Badke, Katherin; Peddie, David; Small, Serena; Balka, Ellen; Hohl, Corinne M

2016-01-01

Adverse drug events (ADEs), harmful unintended consequences of medication use, are a leading cause of hospital admissions, yet are rarely documented in a structured format between care providers. We describe pilot-testing structured ADE documentation fields prior to integration into an electronic medical record (EMR). We completed a qualitative study at two Canadian hospitals. Using data derived from a systematic review of the literature, we developed screen mock-ups for an ADE reporting platform, iteratively revised in participatory workshops with diverse end-user groups. We designed a paper-based form reflecting the data elements contained in the mock-ups. We distributed them to a convenience sample of clinical pharmacists, and completed ethnographic workplace observations while the forms were used. We reviewed completed forms, collected feedback from pharmacists using semi-structured interviews, and coded the data in NVivo for themes related to the ADE form. We completed 25 h of clinical observations, and 24 ADEs were documented. Pharmacists perceived the form as simple and clear, with sufficient detail to capture ADEs. They identified fields for omission, and others requiring more detail. Pharmacists encountered barriers to documenting ADEs including uncertainty about what constituted a reportable ADE, inability to complete patient follow-up, the need for inter-professional communication to rule out alternative diagnoses, and concern about creating a permanent record. Paper-based pilot-testing allowed planning for important modifications in an ADE documentation form prior to implementation in an EMR. While paper-based piloting is rarely reported prior to EMR implementations, it can inform design and enhance functionality. Piloting with other groups of care providers and in different healthcare settings will likely lead to further revisions prior to broader implementations.

Strengthening Community Involvement in Grant Review: Insights from the Community–University Research Partnership (CURES) Pilot Review Process

PubMed Central

Piechowski, Patricia; Warrick, Debra; Grawi, Carolyn; Choate, Celeste; Sneed, Glenda; Carr, Diane; Lota, Kanchan; Key, Kent; Alexander, Valerie; Ghosh, Pratik; Sampselle, Carolyn

2014-01-01

Abstract In 2007, the Michigan Institute for Clinical and Health Research (MICHR) at the University of Michigan received a Clinical and Translational Science Award (CTSA). Within MICHR, the Community Engagement (CE) program supports partnership efforts between researchers, practitioners, and community‐based organizations in specific focal communities throughout Michigan. A key component of the CE program is the Community Engagement Coordinating Council, a group that provides input and guidance on program priorities, strategic planning, and reviews pilot funding proposals for community–academic partnerships. This paper will describe a unique MICHR pilot funding mechanism for Community–University Research Partnerships (CURES) with an emphasis on the ways that community partners are involved in the review process, as well as the benefits, challenges, and insights gained over 5 years of pilot review. There is a growing need for community involvement and expertise in review of funding proposals for community‐engaged research at both institutional and federal levels. The CURES pilot review process is one example of an institutional effort to engage community partners in university funding decisions and has demonstrated clear benefit toward accomplishing the aims of the CTSA. PMID:24456508

Nursing Outcomes for Patients with Risk of Perioperative Positioning Injury.

PubMed

de Lima, Luciana Bjorklund; E Cardozo, Michelle Cardoso; Bernardes, Daniela de Souza; Rabelo-Silva, Eneida Rejane

2018-04-16

To select and refine the outcomes and indicators of Nursing Outcomes Classification for the diagnosis of risk for perioperative positioning injury. Validation study on expert consensus and refinement through pilot study. Eight outcomes and 35 indicators were selected in consensus. After clinical testing was performed, in which 10 patients were assessed at five different times. Eight outcomes and 33 indicators remained in the protocol. This study made it possible to select the most relevant outcomes and indicators to be measured for this diagnosis in clinical practice. Validation studies by consensus and clinical testing are important to promote the accuracy, creating opportunities to legitimize, and improve the concepts of taxonomies. © 2018 NANDA International, Inc.

Safety and Efficacy of Modified Preoperative Lung Nodule Microcoil Localization Without Pleural Marking: A Pilot Study.

PubMed

Kha, Lan-Chau T; Hanneman, Kate; Donahoe, Laura; Chung, Taebong; Pierre, Andrew F; Yasufuku, Kazuhiro; Keshavjee, Shafique; Mayo, John R; Paul, Narinder S; Nguyen, Elsie T

2016-01-01

The purpose of this pilot study was to evaluate the safety and efficacy of preoperative computed tomography (CT)-guided percutaneous microcoil lung nodule localization without pleural marking compared with the established technique with pleural marking. Sixty-three consecutive patients (66.7% female, mean age 61.6±11.4 y) with 64 lung nodules resected between October 2008 and January 2014 were retrospectively evaluated. Of the nodules, 29.7% (n=19) had microcoil deployment with pleural marking (control group) and 70.3% (n=45) had microcoil deployment without pleural marking (pilot group). Clinical, pathologic, and imaging characteristics, radiation dose, CT procedure and operating room time, and complete resection and complication rates were compared between the pilot and control groups. There was no significant difference in nodule size (P=0.552) or distance from the pleural surface (P=0.222) between the pilot and control groups. However, mean procedure duration (53.6±18.3 vs. 72.8±25.3 min, P=0.001) and total effective radiation dose (5.1±2.6 vs. 7.1±4.9 mSv, P=0.039) were significantly lower in the pilot group compared with the control group. CT procedure-related complications (P=0.483) [including pneumothoraces (P=0.769) and pulmonary hemorrhage (P=1.000)], operating room time (P=0.926), complete resection rates (P=0.520), intraoperative complications (P=0.549), and postoperative complications (P=1.000) were similar between the pilot and control groups. Preoperative CT-guided lung nodule microcoil localization performed without visceral pleural marking appears to decrease the CT procedure time and radiation dose while maintaining equivalent complete resection rates and procedural and surgical complications, when compared with microcoil localization performed with pleural marking.

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.

Using tablet-based technology in patient education about systemic therapy options for early-stage breast cancer: a pilot study.

PubMed

Morgan, E R; Laing, K; McCarthy, J; McCrate, F; Seal, M D

2015-10-01

Patient education in early-stage breast cancer has been shown to improve patient well-being and quality of life, but it poses a challenge given the increasingly complex regimens and time constraints in clinical practice. Technology-aided teaching in the clinic could help to improve the understanding of adjuvant systemic therapy for patients. In this prospective pilot study, we used a clinician-administered, tablet-based teaching aid to teach patients with early-stage breast cancer about adjuvant systemic therapy. Participation was offered to newly diagnosed patients with early-stage breast cancer presenting for their first medical oncology visit at a provincial cancer centre. Participants were shown a tablet-based presentation describing procedures, rationales, risks, and benefits of adjuvant systemic therapy as an adjunct to a discussion with the medical oncologist. After the clinic visit, participants completed a questionnaire measuring satisfaction with the visit and knowledge of the treatment plan discussed. The 25 patients recruited for the study had a mean age of 57 years. An offer of upfront chemotherapy alone was made to 12 participants (48%), chemotherapy with trastuzumab to 4 (16%), and hormonal therapy to 9 (36%). Correct answers to all questions related to treatment knowledge were given by 22 patients (88%). Satisfaction with the clinic visit was high (mean satisfaction score: 4.53 ± 0.1 of a possible 5). We found that a tablet-based presentation about adjuvant systemic therapy was satisfactory to patients with early-stage breast cancer and that knowledge retention after the clinic visit was high. Tablet-based teaching could be a feasible and effective way of educating patients in the breast oncology clinic and warrants further investigation in randomized studies.

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.

Improving foot self-care knowledge, self-efficacy, and behaviors in patients with type 2 diabetes at low risk for foot ulceration: a pilot study.

PubMed

Fan, Lifeng; Sidani, Souraya; Cooper-Brathwaite, Angela; Metcalfe, Kelly

2014-12-01

The pilot study aimed to explore the effects of an educational intervention on patients' foot self-care knowledge, self-efficacy, and behaviors in adult patients with type 2 diabetes at low risk for foot ulceration. The intervention consisted of three sessions and was given over a 3-week period. A total of 70 eligible consenting participants were recruited for this pilot study. Fifty-six participants completed the study. The outcomes were assessed at pretest, following the first two sessions, and 3-month follow-up. The findings indicated that the foot self-care educational intervention was effective in improving foot self-care knowledge, self-efficacy and behaviors in adult patients with type 2 diabetes at low risk for foot ulceration. The findings support the effects of the intervention. Future research should evaluate its efficacy using a randomized clinical trial design, and a large sample of patients with type 2 diabetes at low risk for foot ulcerations. © The Author(s) 2013.

iRENEX: a clinically informed decision support system for the interpretation of ⁹⁹mTc-MAG3 scans to detect renal obstruction.

PubMed

Garcia, Ernest V; Taylor, Andrew; Folks, Russell; Manatunga, Daya; Halkar, Raghuveer; Savir-Baruch, Bital; Dubovsky, Eva

2012-09-01

Decision support systems for imaging analysis and interpretation are rapidly being developed and will have an increasing impact on the practice of medicine. RENEX is a renal expert system to assist physicians evaluate suspected obstruction in patients undergoing mercaptoacetyltriglycine (MAG3) renography. RENEX uses quantitative parameters extracted from the dynamic renal scan data using QuantEM™II and heuristic rules in the form of a knowledge base gleaned from experts to determine if a kidney is obstructed; however, RENEX does not have access to and could not consider the clinical information available to diagnosticians interpreting these studies. We designed and implemented a methodology to incorporate clinical information into RENEX, implemented motion detection and evaluated this new comprehensive system (iRENEX) in a pilot group of 51 renal patients. To reach a conclusion as to whether a kidney is obstructed, 56 new clinical rules were added to the previously reported 60 rules used to interpret quantitative MAG3 parameters. All the clinical rules were implemented after iRENEX reached a conclusion on obstruction based on the quantitative MAG3 parameters, and the evidence of obstruction was then modified by the new clinical rules. iRENEX consisted of a library to translate parameter values to certainty factors, a knowledge base with 116 heuristic interpretation rules, a forward chaining inference engine to determine obstruction and a justification engine. A clinical database was developed containing patient histories and imaging report data obtained from the hospital information system associated with the pertinent MAG3 studies. The system was fine-tuned and tested using a pilot group of 51 patients (21 men, mean age 58.2 ± 17.1 years, 100 kidneys) deemed by an expert panel to have 61 unobstructed and 39 obstructed kidneys. iRENEX, using only quantitative MAG3 data agreed with the expert panel in 87 % (34/39) of obstructed and 90 % (55/61) of unobstructed kidneys. iRENEX, using both quantitative and clinical data agreed with the expert panel in 95 % (37/39) of obstructed and 92 % (56/61) of unobstructed kidneys. The clinical information significantly (p < 0.001) increased iRENEX certainty in detecting obstruction over using the quantitative data alone. Our renal expert system for detecting renal obstruction has been substantially expanded to incorporate the clinical information available to physicians as well as advanced quality control features and was shown to interpret renal studies in a pilot group at a standardized expert level. These encouraging results warrant a prospective study in a large population of patients with and without renal obstruction to establish the diagnostic performance of iRENEX.

Quercetin decrease somatic cells count in mastitis of dairy cows.

PubMed

Burmańczuk, Artur; Hola, Piotr; Milczak, Andrzej; Piech, Tomasz; Kowalski, Cezary; Wojciechowska, Beata; Grabowski, Tomasz

2018-04-01

Quercetin is a dietary flavonoid which has an effect on inflammation, angiogenesis and vascular inflammation. In several other flavonoids (e.g. kaempferol, astragalin, alpinetin, baicalein, indirubin), anti-inflammatory mechanism was proven by using mice mastitis model. The aim of the current study was pilot analysis of quercetin tolerability and its impact on somatic cells count (SCC) after multiple intramammary treatment on dairy cows with clinical mastitis. Based on SCC and clinical investigation, 9 dairy cows with clinical mastitis of one quarter were selected for the pilot study. Baseline analysis (hematology, TNFα, SCC) was performed every 24h among all cows three days before the first dose (B1-B3). After the baseline monitoring (B1-B3) eight days treatment (D1-D8) was performed with a high and low dose. Selected blood parameters were analyzed. Starting from D1 to D8, a decrease of SCC in relation to baseline was characterized by declining trend. The presented results allowed the confirmation of the significant influence of quercetin on the reduction of SCC in mastitis in dairy cows after 8days of therapy. Copyright © 2018. Published by Elsevier Ltd.

Electromagnetic navigated condylar positioning after high oblique sagittal split osteotomy of the mandible: a guided method to attain pristine temporomandibular joint conditions.

PubMed

Berger, Moritz; Nova, Igor; Kallus, Sebastian; Ristow, Oliver; Eisenmann, Urs; Dickhaus, Hartmut; Engel, Michael; Freudlsperger, Christian; Hoffmann, Jürgen; Seeberger, Robin

2018-05-01

Reproduction of the exact preoperative proximal-mandible position after osteotomy in orthognathic surgery is difficult to achieve. This clinical pilot study evaluated an electromagnetic (EM) navigation system for condylar positioning after high-oblique sagittal split osteotomy (HSSO). After HSSO as part of 2-jaw surgery, the position of 10 condyles was intraoperatively guided by an EM navigation system. As controls, 10 proximal segments were positioned by standard manual replacement. Accuracy was measured by pre- and postoperative cone beam computed tomography imaging. Overall, EM condyle repositioning was equally accurate compared with manual repositioning (P > .05). Subdivided into 3 axes, significant differences could be identified (P < .05). Nevertheless, no significantly and clinically relevant dislocations of the proximal segment of either the EM or the manual repositioning method could be shown (P > .05). This pilot study introduces a guided method for proximal segment positioning after HSSO by applying the intraoperative EM system. The data demonstrate the high accuracy of EM navigation, although manual replacement of the condyles could not be surpassed. However, EM navigation can avoid clinically hidden, severe malpositioning of the condyles. Copyright © 2017 Elsevier Inc. All rights reserved.

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.

Mixed-reality exercise effects on participation of individuals with spinal cord injuries and developmental disabilities: a pilot study.

PubMed

Heyn, Patricia C; Baumgardner, Chad A; McLachlan, Leslie; Bodine, Cathy

2014-01-01

The purpose of this pilot study was to investigate the effectiveness of a mixed-reality (MR) exercise environment on engagement and enjoyment levels of individuals with spinal cord injury (SCI) and intellectual and developmental disabilities (IDD). Six people participated in this cross-sectional, observational pilot study involving one MR exercise trial. The augmented reality environment was based on a first-person perspective video of a scenic biking/walking trail in Colorado. Males and females (mean age, 43.3 ± 13.7 years) were recruited from a research database for their participation in previous clinical studies. Of the 6 participants, 2 had SCI, 2 had IDD, and 2 were without disability. The primary outcome measurement of this pilot study was the self-reported engagement and enjoyment level of each participant after the exercise trial. All participants reported increased levels of engagement, enjoyment, and immersion involving the MR exercise environment as well as positive feedback recommending this type of exercise approach to peers with similar disabilities. All the participants reported higher than normal levels of enjoyment and 66.7% reported higher than normal levels of being on a real trail. Participants' feedback suggested that the MR environment could be entertaining, motivating, and engaging for users with disabilities, resulting in a foundation for further development of this technology for use in individuals with cognitive and physical disabilities.

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.

Feasibility and pilot study of the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project.

PubMed

Sun, Lena S; Li, Guohua; DiMaggio, Charles J; Byrne, Mary W; Ing, Caleb; Miller, Tonya L K; Bellinger, David C; Han, Sena; McGowan, Francis X

2012-10-01

Animal studies have documented that exposure of the developing brain to commonly used anesthetic agents induces neurotoxicity and late abnormal neurobehavioral functions as adults. Results from clinical studies have all been analyzed using existing data sets, and these studies produced inconsistent results. To provide more definitive evidence to address the clinical relevance of anesthetic neurotoxicity in children, an interdisciplinary team of investigators designed and developed the Pediatric Anesthesia NeuroDevelopment Assessment (PANDA) project. We present pilot study results in 28 sibling pairs recruited and tested at the Columbia University Medical Center (CUMC) and Children's Hospital of Boston (CHB) for the PANDA project. The PANDA project uses an ambidirectional cohort design. We performed prospective neuropsychological assessment in 28 exposed-unexposed sibling pairs from 6 to 11 years of age. The exposed siblings were ASA 1 or 2 and had received a single episode of anesthesia for inguinal hernia repair before the age of 36 months and the unexposed siblings had no anesthesia before the age of 36 months. All the sibling pairs were English speaking and were 36 weeks of gestational age or older. Each sibling pair underwent a direct testing using the Wechsler Abbreviated Scale of Intelligence (WASI) and the NEuroPSYchological Assessment, second edition (NEPSY II), and the parents completed questionnaires related to behavior using CBCL and Conners rating. Data are presented as means±SD. We conducted descriptive analyses of the demographic data. We compared both the exposed and the unexposed sibling groups on WASI and NEPSY II, and total and T scores from CBCL and Conners rating were analyzed as continuous data using the paired t test between the two groups. A P<0.05 was considered significant. After the Institutional Review Board approval for the study at both CUMC and CHB, the full PANDA study protocol was implemented to perform a pilot feasibility study. Our success rate was 96.7% in obtaining detailed medical and anesthesia records in our historical cohort. The scores for verbal IQ (exposed=106.1±16.3, unexposed=109.2±17.9), performance IQ (exposed=109.1±16.0, unexposed=113.9±15.9), and full IQ (exposed=108.2±14.0, unexposed=112.8±16.8) were comparable between the siblings. There were no differences between the two groups in T scores for any of the NEPSY II subdomains, CBCL, or Conners rating. An abstraction protocol with web-based electronic data capture forms also was developed in conjunction with the International Center for Health Outcomes and Innovation Research (InCHOIR). The pilot study provided useful information for feasibility to recruit the sample size and to obtain relevant clinical data. For the final study protocol, both the neuropsychological battery and the age range for testing were revised. Our results confirmed the feasibility of our study approach and yielded pilot data from neuropsychological testing.

Can virtual reality be used to conduct mass prophylaxis clinic training? A pilot program.

PubMed

Yellowlees, Peter; Cook, James N; Marks, Shayna L; Wolfe, Daniel; Mangin, Elanor

2008-03-01

To create and evaluate a pilot bioterrorism defense training environment using virtual reality technology. The present pilot project used Second Life, an internet-based virtual world system, to construct a virtual reality environment to mimic an actual setting that might be used as a Strategic National Stockpile (SNS) distribution site for northern California in the event of a bioterrorist attack. Scripted characters were integrated into the system as mock patients to analyze various clinic workflow scenarios. Users tested the virtual environment over two sessions. Thirteen users who toured the environment were asked to complete an evaluation survey. Respondents reported that the virtual reality system was relevant to their practice and had potential as a method of bioterrorism defense training. Computer simulations of bioterrorism defense training scenarios are feasible with existing personal computer technology. The use of internet-connected virtual environments holds promise for bioterrorism defense training. Recommendations are made for public health agencies regarding the implementation and benefits of using virtual reality for mass prophylaxis clinic training.

Clinical use of cold atmospheric pressure argon plasma in chronic leg ulcers: A pilot study.

PubMed

Ulrich, C; Kluschke, F; Patzelt, A; Vandersee, S; Czaika, V A; Richter, H; Bob, A; Hutten, J von; Painsi, C; Hüge, R; Kramer, A; Assadian, O; Lademann, J; Lange-Asschenfeldt, B

2015-05-01

In the age of multiresistant microbes and the increasing lack of efficient antibiotics, conventional antiseptics play a critical role in the prevention and therapy of wound infections. Recent studies have demonstrated the antiseptic effects of cold atmospheric pressure plasma (APP). In this pilot, study we investigate the overall suitability of one of the first APP sources for wound treatment focusing on its potential antimicrobial effects. The wound closure rate and the bacterial colonisation of the wounds were investigated. Patients suffering from chronic leg ulcers were treated in a clinical controlled monocentric trial with either APP or octenidine (OCT). In patients who presented with more than one ulceration in different locations, one was treated with APP and the other one with OCT. Each group was treated three times a week over a period of two weeks. The antimicrobial efficacy was evaluated immediately after and following two weeks of treatment. Wounds treated with OCT showed a significantly higher microbial reduction (64%) compared to wounds treated with APP (47%) immediately after the treatment. Over two weeks of antiseptic treatment the bacterial density was reduced within the OCT group (-35%) compared to a slight increase in bacterial density in the APP-treated group (+12%). Clinically, there were no signs of delayed wound healing observed in either group and both treatments were well tolerated. The immediate antimicrobial effects of the APP prototype source were almost comparable to OCT without any signs of cytotoxicity. This pilot study is limited by current configurations of the plasma source, where the narrow plasma beam made it difficult to cover larger wound surface areas and in order to avoid untreated areas of the wound bed, smaller wounds were assigned to the APP-treatment group. This limits the significance of AAP-related effects on the wound healing dynamics, as smaller wounds tend to heal faster than larger wounds. However, clinical wound healing studies on a larger scale now seem justifiable. A more advanced plasma source prototype allowing the treatment of larger wounds will address APP's influence on healing dynamics, synergetic treatment with current antiseptics and effects on multiresistant bacteria.

A single-arm pilot study of guided self-help treatment based cognitive behavioral therapy for bulimia nervosa in Japanese clinical settings.

PubMed

Setsu, R; Asano, K; Numata, N; Tanaka, M; Ibuki, H; Yamamoto, T; Uragami, R; Matsumoto, J; Hirano, Y; Iyo, M; Shimizu, E; Nakazato, M

2018-04-25

Guided self-help treatments based on cognitive behavioral therapy (CBT-GSH) are regarded as a first-line effective treatment for bulimia nervosa (BN). With limited application for CBT-GSH in Japanese clinical settings, we conducted a single arm pilot study in order to confirm the acceptability and availability of CBT-GSH in Japan. 25 women with BN received 16-20 sessions of face-to-face CBT-GSH. Primary outcomes were the completion rate of intervention and abstinence rates from objective bingeing and purging as assessed by the Eating Disorder Examination. Secondary outcomes were other self-report measurements of the frequency of bingeing and purging, and characteristic psychopathologies of eating disorders. Assessments were conducted before CBT as baseline as well as after CBT. 92% (23/25) of the participants completed the CBT sessions. After CBT-GSH, 40% (10/25) of the participants (intention-to-treat) achieved symptom abstinence. The mean binge and purge episodes during the previous 28 days improved from 21.88 to 10.96 (50% reduction) and from 22.44 to 10.88 (52% reduction), each (before CBT-GSH to after CBT-GSH), and the within-group effect sizes were medium (Cohen's d = 0.67, 0.65, each). Our study provided a preliminary evidence about the feasibility of CBT-GSH in Japanese clinical settings for the future. Trial registration This study was registered retrospectively in the national UMIN Clinical Trials Registry on July 10, 2013 (registration ID: UMIN000011120).

Calculus detection calibration among dental hygiene faculty members utilizing dental endoscopy: a pilot study.

PubMed

Partido, Brian B; Jones, Archie A; English, Dana L; Nguyen, Carol A; Jacks, Mary E

2015-02-01

Dental and dental hygiene faculty members often do not provide consistent instruction in the clinical environment, especially in tasks requiring clinical judgment. From previous efforts to calibrate faculty members in calculus detection using typodonts, researchers have suggested using human subjects and emerging technology to improve consistency in clinical instruction. The purpose of this pilot study was to determine if a dental endoscopy-assisted training program would improve intra- and interrater reliability of dental hygiene faculty members in calculus detection. Training included an ODU 11/12 explorer, typodonts, and dental endoscopy. A convenience sample of six participants was recruited from the dental hygiene faculty at a California community college, and a two-group randomized experimental design was utilized. Intra- and interrater reliability was measured before and after calibration training. Pretest and posttest Kappa averages of all participants were compared using repeated measures (split-plot) ANOVA to determine the effectiveness of the calibration training on intra- and interrater reliability. The results showed that both kinds of reliability significantly improved for all participants and the training group improved significantly in interrater reliability from pretest to posttest. Calibration training was beneficial to these dental hygiene faculty members, especially those beginning with less than full agreement. This study suggests that calculus detection calibration training utilizing dental endoscopy can effectively improve interrater reliability of dental and dental hygiene clinical educators. Future studies should include human subjects, involve more participants at multiple locations, and determine whether improved rater reliability can be sustained over time.

Social abilities and gender roles in adolescent girls with polycystic ovary syndrome - a pilot study.

PubMed

Zachurzok, Agnieszka; Gawlik, Aneta; Nowak, Aleksandra; Drosdzol-Cop, Agnieszka; Małecka-Tendera, Ewa

2014-01-01

Clinical and hormonal features of polycystic ovary syndrome (PCOS), which may be present already in adolescence, can significantly influence the psychological development and wellbeing of a young woman.The aim of this pilot study was to determine social competence and gender roles in adolescent girls with PCOS compared to healthy peers, and to evaluate the relationship between psychological profile and clinical and hormonal components of PCOS. In 28 adolescent girls with PCOS, and 12 healthy regularly menstruating girls, clinical evaluation and hormonal profile were assessed and social competence inventory (SCI) and psychological gender inventory (PGI) tests were performed. There were no significant differences in all parts of SCI in absolute numbers or in sten scores between the study and the control group. Also in PGI, in both the feminine and masculine gender schemes, the differences between the groups were statistically insignificant. In the study group, DHEAS concentration correlated positively with self presentation score (r = 0.4, p = 0.03). There was also a significant negative correlation between testosterone level and SCI score (r = -0.5, p = 0.01) as well as assertiveness score (r = -0.5, p = 0.02). No significant correlations between SCI or PGI with BMI z-score or hirsutism score were found. Despite the existence of clinical and biochemical features that can influence sociopsychological condition, in adolescent girls with PCOS, social abilities and sex-typical behaviours do not seem to be disturbed.

The Biomarker Knowledge System Informatics Pilot Project Supplement To The Biomarker Development Laboratory at Moffitt (Bedlam) — EDRN Public Portal

Cancer.gov

The Biomarker Knowledge System Informatics Pilot Project goal will develop network interfaces among databases that contain information about existing clinical populations and biospecimens and data relating to those specimens that are important in biomarker assay validation. This protocol comprises one of two that will comprise the Moffitt participation in the Biomarker Knowledge System Informatics Pilot Project. THIS PROTOCOL (58) is the Sput-Epi Database.

A Virtual Patient Software Program to Improve Pharmacy Student Learning in a Comprehensive Disease Management Course

PubMed Central

Casale, Jillian P.; Skirvin, J. Andrew; DiVall, Margarita V.

2013-01-01

Objective. To implement and assess the impact of a virtual patient pilot program on pharmacy students’ clinical competence skills. Design. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessment. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students’ posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Conclusion. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes. PMID:24159213

Can Robotic Interaction Improve Joint Attention Skills?

ERIC Educational Resources Information Center

Warren, Zachary E.; Zheng, Zhi; Swanson, Amy R.; Bekele, Esubalew; Zhang, Lian; Crittendon, Julie A.; Weitlauf, Amy F.; Sarkar, Nilanjan

2015-01-01

Although it has often been argued that clinical applications of advanced technology may hold promise for addressing impairments associated with autism spectrum disorder (ASD), relatively few investigations have indexed the impact of intervention and feedback approaches. This pilot study investigated the application of a novel robotic interaction…

CCR study: evidence for benefit of TARP vaccine for men with early stage prostate cancer | Center for Cancer Research

Cancer.gov

Results from a pilot clinical trial found that TARP, or T-cell receptor gamma chain alternate reading frame protein, vaccination slowed prostate-specific antigen (PSA) rise in the majority of patients with early stage prostate cancer.

Web-Based Simulation in Psychiatry Residency Training: A Pilot Study

ERIC Educational Resources Information Center

Gorrindo, Tristan; Baer, Lee; Sanders, Kathy M.; Birnbaum, Robert J.; Fromson, John A.; Sutton-Skinner, Kelly M.; Romeo, Sarah A.; Beresin, Eugene V.

2011-01-01

Background: Medical specialties, including surgery, obstetrics, anesthesia, critical care, and trauma, have adopted simulation technology for measuring clinical competency as a routine part of their residency training programs; yet, simulation technologies have rarely been adapted or used for psychiatry training. Objective: The authors describe…

Teaching the physician-manager role to psychiatric residents: development and implementation of a pilot curriculum.

PubMed

Stergiopoulos, Vicky; Maggi, Julie; Sockalingam, Sanjeev

2009-01-01

The authors describe a pilot physician-manager curriculum designed to address the learning needs of psychiatric residents in administrative psychiatry and health systems. The pilot curriculum includes a junior and a senior toolkit of four workshops each. The junior toolkit introduces postgraduate-year two (PGY-2) residents to the principles of teamwork, conflict resolution, quality improvement, and program planning and evaluation. The senior toolkit exposes PGY-4 residents to leadership and change management, organizational structures, mental health and addictions reform, and self and career development. Following curriculum implementation at the University of Toronto, residents rated the importance and clinical relevance of curriculum objectives and commented on the strengths and weaknesses of the workshops and areas needing improvement. The pilot curriculum was successfully introduced at the University of Toronto in 2006. Residents rated the curriculum very highly and commented that interactive learning and contextually relevant topics are essential in meeting their needs. It is possible to successfully introduce a physician-manager curriculum early during psychiatric residency training, to match the specific needs of clinical rotations. Interactive techniques and clinical illustrations may be crucial in facilitating teaching and learning the physician-manager role. The authors discuss barriers, facilitators, and critical success factors in implementing such a curriculum.

[Multifamily therapy in children with learning disabilities].

PubMed

Retzlaff, Rüdiger; Brazil, Susanne; Goll-Kopka, Andrea

2008-01-01

Multifamily therapy is an evidence-based method used in the treatment and prevention of severe psychiatric disorders, behavioral problems and physical illnesses in children, adolescents and adults. For preventive family-oriented work with children with learning disorders there is a lack of therapeutic models. This article presents results from an innovative pilot project--multiple family groups for families with a learning disabled child of primary school age (six to eleven years old). Based on a systemic approach, this resource-oriented program integrates creative, activity-based interventions and group therapy techniques and conveys a comprehensive understanding of the challenges associated with learning disorders. Because of the pilot character of the study and the small sample size, the results have to be interpreted with care. The results do however clearly support the wider implementation and evaluation of the program in child guidance clinics, social-pediatric centers, as well as child and adolescent clinics and schools.

Reflective dialogue in clinical supervision: A pilot study involving collaborative review of supervision videos.

PubMed

Hill, Hamish R M; Crowe, Trevor P; Gonsalvez, Craig J

2016-01-01

To pilot an intervention involving reflective dialogue based on video recordings of clinical supervision. Fourteen participants (seven psychotherapists and their supervisors) completed a reflective practice protocol after viewing a video of their most recent supervision session, then shared their reflections in a second session. Thematic analysis of individual reflections and feedback resulted in the following dominant themes: (1) Increased discussion of supervisee anxiety and the tensions between autonomy and dependence; (2) intentions to alter supervisory roles and practice; (3) identification of and reflection on parallel process (defined as the dynamic transmission of relationship patterns between therapy and supervision); and (4) a range of perceived impacts including improvements in supervisory alliance. The results suggest that reflective dialogue based on supervision videos can play a useful role in psychotherapy supervision, including with relatively inexperienced supervisees. Suggestions are provided for the encouragement of ongoing reflective dialogue in routine supervision practice.

Using a medical simulation center as an electronic health record usability laboratory

PubMed Central

Landman, Adam B; Redden, Lisa; Neri, Pamela; Poole, Stephen; Horsky, Jan; Raja, Ali S; Pozner, Charles N; Schiff, Gordon; Poon, Eric G

2014-01-01

Usability testing is increasingly being recognized as a way to increase the usability and safety of health information technology (HIT). Medical simulation centers can serve as testing environments for HIT usability studies. We integrated the quality assurance version of our emergency department (ED) electronic health record (EHR) into our medical simulation center and piloted a clinical care scenario in which emergency medicine resident physicians evaluated a simulated ED patient and documented electronically using the ED EHR. Meticulous planning and close collaboration with expert simulation staff was important for designing test scenarios, pilot testing, and running the sessions. Similarly, working with information systems teams was important for integration of the EHR. Electronic tools are needed to facilitate entry of fictitious clinical results while the simulation scenario is unfolding. EHRs can be successfully integrated into existing simulation centers, which may provide realistic environments for usability testing, training, and evaluation of human–computer interactions. PMID:24249778

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.

[Changing of the patient safety culture in the pilot institutes of the Hungarian accreditation program].

PubMed

Lám, Judit; Merész, Gergő; Bakacsi, Gyula; Belicza, Éva; Surján, Cecília; Takács, Erika

2016-10-01

The accreditation system for health care providers was developed in Hungary aiming to increase safety, efficiency, and efficacy of care and optimise its organisational operation. The aim of this study was to assess changes of organisational culture in pilot institutes of the accreditation program. 7 volunteer pilot institutes using an internationally validated questionnaire were included. The impact study was performed in 2 rounds: the first before the introduction of the accreditation program, and the second a year later, when the standards were already known. Data were analysed using descriptive statistics and logistic regression models. Statistically significant (p<0.05) positive changes were detected in hospitals in three dimensions: organisational learning - continuous improvement, communication openness, teamwork within the unit while in outpatient clinics: overall perceptions of patient safety, and patient safety within the unit. Organisational culture in the observed institutes needs improvement, but positive changes already point to a safer care. Orv. Hetil., 2016, 157(42), 1667-1673.

Could situational judgement tests be used for selection into dental foundation training?

PubMed

Patterson, F; Ashworth, V; Mehra, S; Falcon, H

2012-07-13

To pilot and evaluate a machine-markable situational judgement test (SJT) designed to select candidates into UK dental foundation training. Single centre pilot study. UK postgraduate deanery in 2010. Seventy-four candidates attending interview for dental foundation training in Oxford and Wessex Deaneries volunteered to complete the situational judgement test. The situational judgement test was developed to assess relevant professional attributes for dentistry (for example, empathy and integrity) in a machine-markable format. Test content was developed by subject matter experts working with experienced psychometricians. Evaluation of psychometric properties of the pilot situational judgement test (for example, reliability, validity and fairness). Scores in the dental foundation training selection process (short-listing and interviews) were used to examine criterion-related validity. Candidates completed an evaluation questionnaire to examine candidate reactions and face validity of the new test. Forty-six candidates were female and 28 male; mean age was 23.5-years-old (range 22-32). Situational judgement test scores were normally distributed and the test showed good internal reliability when corrected for test length (α = 0.74). Situational judgement test scores positively correlated with the management, leadership and professionalism interview (N = 50; r = 0.43, p <0.01) but not with the clinical skills interview, providing initial evidence of criterion-related validity as the situational judgement test is designed to test non-cognitive professional attributes beyond clinical knowledge. Most candidates perceived the situational judgement test as relevant to dentistry, appropriate for their training level, and fair. This initial pilot study suggests that a situational judgement test is an appropriate and innovative method to measure professional attributes (eg empathy and integrity) for selection into foundation training. Further research will explore the long-term predictive validity of the situational judgement test once candidates have entered training.

Effectiveness of an Integrated Approach to HIV and Hypertension Care in Rural South Africa: Controlled Interrupted Time-Series Analysis.

PubMed

Ameh, Soter; Klipstein-Grobusch, Kerstin; Musenge, Eustasius; Kahn, Kathleen; Tollman, Stephen; Gómez-Olivé, Francesc Xavier

2017-08-01

South Africa faces a dual burden of HIV/AIDS and noncommunicable diseases. In 2011, a pilot integrated chronic disease management (ICDM) model was introduced by the National Health Department into selected primary health care (PHC) facilities. The objective of this study was to assess the effectiveness of the ICDM model in controlling patients' CD4 counts (>350 cells/mm) and blood pressure [BP (<140/90 mm Hg)] in PHC facilities in the Bushbuckridge municipality, South Africa. A controlled interrupted time-series study was conducted using the data from patients' clinical records collected multiple times before and after the ICDM model was initiated in PHC facilities in Bushbuckridge. Patients ≥18 years were recruited by proportionate sampling from the pilot (n = 435) and comparing (n = 443) PHC facilities from 2011 to 2013. Health outcomes for patients were retrieved from facility records for 30 months. We performed controlled segmented regression to model the monthly averages of individuals' propensity scores using autoregressive moving average model at 5% significance level. The pilot facilities had 6% greater likelihood of controlling patients' CD4 counts than the comparison facilities (coefficient = 0.057; 95% confidence interval: 0.056 to 0.058; P < 0.001). Compared with the comparison facilities, the pilot facilities had 1.0% greater likelihood of controlling patients' BP (coefficient = 0.010; 95% confidence interval: 0.003 to 0.016; P = 0.002). Application of the model had a small effect in controlling patients' CD4 counts and BP, but showed no overall clinical benefit for the patients; hence, the need to more extensively leverage the HIV program for hypertension treatment.

Sublingual Buprenorphine/Naloxone for Chronic Pain in At-Risk Patients: Development and Pilot Test of a Clinical Protocol

PubMed Central

Rosenblum, Andrew; Cruciani, Ricardo A.; Strain, Eric C; Cleland, Charles M.; Joseph, Herman; Magura, Stephen; Marsch, Lisa A; McNicholas, Laura F; Savage, Seddon R; Sundaram, Arun; Portenoy, Russell K.

2013-01-01

Objective Sublingual buprenorphine/naloxone (Bup/Nx) is approved for addiction treatment and may be useful for pain management, particularly in opioid-treated pain patients with nonadherence behaviors. The transition of opioid-treated pain patients to buprenorphine carries the risk of precipitated withdrawal and increased pain. This study convened pain and addiction specialists to develop and pilot a clinical protocol for safe transitioning to Bup/Nx. Design The protocol was revised three times based on outside expert review and pilot study observations. The pilot was conducted with a prospective cohort of 12 patients with moderate to severe chronic pain, who were receiving long-term opioid therapy with any full μ-agonist drug, and had exhibited one or more aberrant drug-related behaviors. Patients were followed up for 3 to 6 months with the expectation that they would experience few adverse events and report lower pain severity. Results The three patients on the highest baseline opioid dose (equivalent to 303–450 mg of oral morphine) and the three on the lowest doses (≤20 mg) had early adverse events (AEs) when switched to Bup/Nx and did not complete the trial. Of the remaining six, one withdrew due to AEs; one responded well, then withdrew; and four completed a three-month trial. A mixed effects model controlling for dropouts found that average and worst pain significantly decreased after the switch to Bup/Nx (both p < .01). Conclusion Based on this experience, the protocol recommends Bup/Nx for pain only when baseline opioid doses are within bounds that reduce AEs at transition and incorporates dose flexibility to further reduce risks. This protocol warrants further testing. PMID:23264315

Development of the Clinical Teaching Effectiveness Questionnaire in the United States.

PubMed

Wormley, Michelle E; Romney, Wendy; Greer, Anna E

2017-01-01

The purpose of this study was to develop a valid measure for assessing clinical teaching effectiveness within the field of physical therapy. The Clinical Teaching Effectiveness Questionnaire (CTEQ) was developed via a 4-stage process, including (1) initial content development, (2) content analysis with 8 clinical instructors with over 5 years of clinical teaching experience, (3) pilot testing with 205 clinical instructors from 2 universities in the Northeast of the United States, and (4) psychometric evaluation, including principal component analysis. The scale development process resulted in a 30-item questionnaire with 4 sections that relate to clinical teaching: learning experiences, learning environment, communication, and evaluation. The CTEQ provides a preliminary valid measure for assessing clinical teaching effectiveness in physical therapy practice.

A novel smart lighting clinical testbed.

PubMed

Gleason, Joseph D; Oishi, Meeko; Simkulet, Michelle; Tuzikas, Arunas; Brown, Lee K; Brueck, S R J; Karlicek, Robert F

2017-07-01

A real-time, feedback-capable, variable spectrum lighting system was recently installed at the University of New Mexico Hospital to facilitate biomedical research on the health impacts of lighting. The system consists of variable spectrum troffers, color sensors, occupancy sensors, and computing and communication infrastructure, and is the only such clinical facility in the US. The clinical environment posed special challenges for installation as well as for ongoing maintenance and operations. Pilot studies are currently underway to evaluate the effectiveness of the system to regulate circadian phase in subjects with delayed sleep-wake phase disorder.

Vestibular rehabilitation using video gaming in adults with dizziness: a pilot study.

PubMed

Phillips, J S; Fitzgerald, J; Phillis, D; Underwood, A; Nunney, I; Bath, A

2018-03-01

To determine the effectiveness of vestibular rehabilitation using the Wii Fit balance platform, in adults with dizziness. A single-site prospective clinical trial was conducted in a university hospital in the UK. Forty patients with dizziness, who would normally be candidates for vestibular rehabilitation, were identified and considered as potential participants. Participants were randomised into either the treatment group (the Wii Fit group) or the control group (standard customised vestibular rehabilitation protocol). Participants were assessed over a 16-week period using several balance and quality of life questionnaires. Both exercise regimes resulted in a reduction of dizziness and an improvement in quality of life scores over time, but no statistically significant difference between the two interventions was identified. This pilot study demonstrated that use of the Wii Fit balance platform resulted in a statistically significant improvement in balance function and quality of life. Furthermore, outcomes were comparable to a similar group of individuals following a standard customised vestibular rehabilitation protocol. The study provides useful information to inform the design and execution of a larger clinical trial.

Six-year clinical outcome of single implant-retained mandibular overdentures--a pilot study.

PubMed

Passia, Nicole; Wolfart, Stefan; Kern, Matthias

2015-10-01

The aim of this prospective pilot study was to evaluate the prosthodontic maintenance as well as the implant outcome of single implant-retained mandibular overdentures over an observation period of 6 years. Eleven edentulous patients received one single implant in the midline of the mandible. Denture bases were temporarily relined and 2 months later provided with a ball attachment for implant retention. Implant related parameters and prosthodontic maintenance interventions were assessed 4 weeks after implant loading and then once a year. Over a mean observation period of 75.9 months, no implant was lost. The most frequent prosthetic maintenance intervention was activation of the matrix due to loss of retention, followed by exchange of the female part. Eight denture bases had to be repaired after a fracture in the midline area. Within the limitations of this preliminary clinical study, the concept of a single midline implant to retain a mandibular complete denture was a successful treatment option for elderly edentulous patients. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Treatment of inflammatory facial acne vulgaris in Chinese patients with the 1450-nm diode laser: a pilot study

NASA Astrophysics Data System (ADS)

Liu, Huaxu; Dang, Yongyan; Wang, Zhan; Ma, Li; Ren, Qiushi

2007-02-01

The 1450-nm diode laser has been found to be effective for the treatment of inflammatory acne in USA, Europe and Japan. However, there is no report on its efficacy in Chinese acne vulgaris patients. We conduct this pilot study to evaluate the efficacy and safety of the 1450-nm diode laser in the treatment of inflammatory facial acne vulgaris in Chinese patients. Nineteen patients with inflammatory facial acne were treated with the 1450-nm diode laser at 4- to 6-week intervals. Clinical photographs and lesion counts were obtained at baseline and after each treatment. Subjective evaluation of response to treatment and pain was assessed using a questionnaire. In our study, clinical improvement was seen in all patients and was generally dramatic. Lesion counts decreased 34% after one treatment (p<0.01), 56% after two treatments (p<0.01), and 81% after three treatments (p<0.01). However, the treatment-related pain was comparatively hard to be tolerated in Chinese patitents, and the other main adverse effect was the hyper-pigmentation after treatments (36.84%, 7/19).

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus

PubMed Central

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-01-01

Background Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). Results Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. Conclusion Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury. PMID:15679916

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus.

PubMed

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-10-26

BACKGROUND: Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). RESULTS: Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. CONCLUSION: Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury.

Developing leadership capacity for guideline use: a pilot cluster randomized control trial.

PubMed

Gifford, Wendy A; Davies, Barbara L; Graham, Ian D; Tourangeau, Ann; Woodend, A Kirsten; Lefebre, Nancy

2013-02-01

The importance of leadership to influence nurses' use of clinical guidelines has been well documented. However, little is known about how to develop and evaluate leadership interventions for guideline use. The purpose of this study was to pilot a leadership intervention designed to influence nurses' use of guideline recommendations when caring for patients with diabetic foot ulcers in home care nursing. This paper reports on the feasibility of implementing the study protocol, the trial findings related to nursing process outcomes, and leadership behaviors. A mixed methods pilot study was conducted with a post-only cluster randomized controlled trial and descriptive qualitative interviews. Four units were randomized to control or experimental groups. Clinical and management leadership teams participated in a 12-week leadership intervention (workshop, teleconferences). Participants received summarized chart audit data, identified goals for change, and created a team leadership action. Criteria to assess feasibility of the protocol included: design, intervention, measures, and data collection procedures. For the trial, chart audits compared differences in nursing process outcomes. 8-item nursing assessments score. Secondary outcome: 5-item score of nursing care based on goals for change identified by intervention participants. Qualitative interviews described leadership behaviors that influenced guideline use. Conducting this pilot showed some aspects of the study protocol were feasible, while others require further development. Trial findings observed no significant difference in the primary outcome. A significant increase was observed in the 5-item score chosen by intervention participants (p = 0.02). In the experimental group more relations-oriented leadership behaviors, audit and feedback and reminders were described as leadership strategies. Findings suggest that a leadership intervention has the potential to influence nurses' use of guideline recommendations, but further work is required to refine the intervention and outcome measures. A taxonomy of leadership behaviors is proposed to inform future research. © 2012 The authors. World Views on Evidence-Based Nursing © Sigma Theta Tau International.

Implementation of interprofessional learning activities in a professional practicum: The emerging role of technology.

PubMed

Brault, Isabelle; Therriault, Pierre-Yves; St-Denis, Louise; Lebel, Paule

2015-01-01

To prepare future healthcare professionals to collaborate effectively, many universities have developed interprofessional education programs (IPE). Till date, these programs have been mostly courses or clinical simulation experiences. Few attempts have been made to pursue IPE in healthcare clinical settings. This article presents the results of a pilot project in which interprofessional learning activities (ILAs) were implemented during students' professional practicum and discusses the actual and potential use of informatics in the ILA implementation. We conducted a pilot study in four healthcare settings. Our analysis is based on focus group interviews with trainees, clinical supervisors, ILA coordinators, and education managers. Overall, ILAs led to better clarification of roles and understanding of each professional's specific expertise. Informatics was helpful for developing a common language about IPE between trainees and healthcare professionals; opportunities for future application of informatics were noted. Our results support the relevance of ILAs and the value of promoting professional exchanges between students of different professions, both in academia and in the clinical setting. Informatics appears to offer opportunities for networking among students from different professions and for team members' professional development. The use of technology facilitated communication among the participants.

Improving Emotional Face Perception in Autism with Diuretic Bumetanide: A Proof-of-Concept Behavioral and Functional Brain Imaging Pilot Study

ERIC Educational Resources Information Center

Hadjikhani, Nouchine; Zürcher, Nicole R; Rogier, Ophelie; Ruest, Torsten; Hippolyte, Loyse; Ben-Ari, Yehezkel; Lemonnier, Eric

2015-01-01

Clinical observations have shown that GABA-acting benzodiazepines exert paradoxical excitatory effects in autism, suggesting elevated intracellular chloride (Cl-)[subscript i] and excitatory action of GABA. In a previous double-blind randomized study, we have shown that the diuretic NKCC1 chloride importer antagonist bumetanide, that decreases…

Predicting Response of ADHD Symptoms to Methylphenidate Treatment Based on Comorbid Anxiety

ERIC Educational Resources Information Center

Blouin, Brittany; Maddeaux, Cindy; Stanley Firestone, Jill; van Stralen, Judy

2010-01-01

Objective: In this small pilot study, the association of comorbid anxiety with the treatment of ADHD is studied. Methods: Eighteen volunteers from a pediatric clinic are tested for ADHD and anxiety and assessed for behavioral and cognitive ADHD symptomology. Response to methylphenidate as treatment for ADHD symptoms is measured 2 to 3 weeks, and…

Remote Capture of Human Voice Acoustical Data by Telephone: A Methods Study

ERIC Educational Resources Information Center

Cannizzaro, Michael S.; Reilly, Nicole; Mundt, James C.; Snyder, Peter J.

2005-01-01

In this pilot study we sought to determine the reliability and validity of collecting speech and voice acoustical data via telephone transmission for possible future use in large clinical trials. Simultaneous recordings of each participant's speech and voice were made at the point of participation, the local recording (LR), and over a telephone…

Evaluating Conflicts of Interest in Research Presented in CME Venues

ERIC Educational Resources Information Center

Davis, Nancy L.; Galliher, James M.; Spano, Mindy S.; Main, Deborah S.; Brannigan, Michael; Pace, Wilson D.

2008-01-01

Introduction: There is much in the literature regarding the potential for commercial bias in clinical research and in continuing medical education (CME), but no studies were found regarding the potential for bias in reporting original research in CME venues. This pilot study investigated the presence of perceived bias in oral and print content of…

Reduction of fibromyalgia symptoms through intravenous nutrient therapy: results of a pilot clinical trial.

PubMed

Massey, Patrick B

2007-01-01

To evaluate the effectiveness of a modified Myers' formula of intravenous nutrient therapy (IVNT) on the symptoms of fibromyalgia (FM) in therapy-resistant FM patients. In this pilot clinical trial, 7 participants with therapy resistant FM were given IVNT once per week for 8 weeks. Patient's pain levels, fatigue, and activities of daily living were evaluated weekly. All participants reported decreased pain levels, decreased fatigue, and increased activities of daily living. Participants noted increased energy levels within 24-48 hours of the initial infusion. At the end of the study, all participants reported increased energy and activities of daily living as well as a 60% reduction in pain (P=.005) and an 80% decrease in fatigue (P=-.005). No participants, however, reported complete or lasting resolution of pain or fatigue. No side effects were reported. Anecdotal reports have indicated benefit for IVNT for patients with chronic pain, including FM. However, except for 2 reports, the medical literature is devoid of any studies of IVNT for the treatment of FM. In this pilot study, 7 participants received IVNT once a week for 8 weeks. All participants had long-standing FM (at least 8 years) and had tried conventional therapies, such as antidepressants, nonsteroidal anti-inflammatory drugs, and exercise, without significant or lasting relief. All had improvement in symptoms and increases in their activities of daily living, although no participant reported complete resolution of symptoms. IVNT appears to be safe to reduce FM symptoms.

Development of a Social Skills Assessment Screening Scale for Psychiatric Rehabilitation Settings: A Pilot Study.

PubMed

Bhola, Poornima; Basavarajappa, Chethan; Guruprasad, Deepti; Hegde, Gayatri; Khanam, Fatema; Thirthalli, Jagadisha; Chaturvedi, Santosh K

2016-01-01

Deficits in social skills may present in a range of psychiatric disorders, particularly in the more serious and persistent conditions, and have an influence on functioning across various domains. This pilot study aimed at developing a brief measure, for structured evaluation and screening for social skills deficits, which can be easily integrated into routine clinical practice. The sample consisted of 380 inpatients and their accompanying caregivers, referred to Psychiatric Rehabilitation Services at a tertiary care government psychiatric hospital. The evaluation included an Inpatient intake Proforma and the 20-item Social Skills Assessment Screening Scale (SSASS). Disability was assessed using the Indian Disability Evaluation and Assessment Scale (IDEAS) for a subset of 94 inpatients. The analysis included means and standard deviations, frequency and percentages, Cronbach's alpha to assess internal consistency, t -tests to assess differences in social skills deficits between select subgroups, and correlation between SSASS and IDEAS scores. The results indicated the profile of social skills deficits assessed among the inpatients with varied psychiatric diagnoses. The "psychosis" group exhibited significantly higher deficits than the "mood disorder" group. Results indicated high internal consistency of the SSASS and adequate criterion validity demonstrated by correlations with select IDEAS domains. Modifications were made to the SSASS following the pilot study. The SSASS has potential value as a measure for screening and individualised intervention plans for social skills training in mental health and rehabilitation settings. The implications for future work on the psychometric properties and clinical applications are discussed.

Reducing stigma among healthcare providers to improve mental health services (RESHAPE): protocol for a pilot cluster randomized controlled trial of a stigma reduction intervention for training primary healthcare workers in Nepal.

PubMed

Kohrt, Brandon A; Jordans, Mark J D; Turner, Elizabeth L; Sikkema, Kathleen J; Luitel, Nagendra P; Rai, Sauharda; Singla, Daisy R; Lamichhane, Jagannath; Lund, Crick; Patel, Vikram

2018-01-01

Non-specialist healthcare providers, including primary and community healthcare workers, in low- and middle-income countries can effectively treat mental illness. However, scaling-up mental health services within existing health systems has been limited by barriers such as stigma against people with mental illness. Therefore, interventions are needed to address attitudes and behaviors among non-specialists. Aimed at addressing this gap, RE ducing S tigma among H ealthc A re P roviders to Improv E mental health services (RESHAPE) is an intervention in which social contact with mental health service users is added to training for non-specialist healthcare workers integrating mental health services into primary healthcare. This protocol describes a mixed methods pilot and feasibility study in primary care centers in Chitwan, Nepal. The qualitative component will include key informant interviews and focus group discussions. The quantitative component consists of a pilot cluster randomized controlled trial (c-RCT), which will establish parameters for a future effectiveness study of RESHAPE compared to training as usual (TAU). Primary healthcare facilities (the cluster unit, k  = 34) will be randomized to TAU or RESHAPE. The direct beneficiaries of the intervention are the primary healthcare workers in the facilities ( n  = 150); indirect beneficiaries are their patients ( n  = 100). The TAU condition is existing mental health training and supervision for primary healthcare workers delivered through the Programme for Improving Mental healthcarE (PRIME) implementing the mental health Gap Action Programme (mhGAP). The primary objective is to evaluate acceptability and feasibility through qualitative interviews with primary healthcare workers, trainers, and mental health service users. The secondary objective is to collect quantitative information on health worker outcomes including mental health stigma (Social Distance Scale), clinical knowledge (mhGAP), clinical competency (ENhancing Assessment of Common Therapeutic factors, ENACT), and implicit attitudes (Implicit Association Test, IAT), and patient outcomes including stigma-related barriers to care, daily functioning, and symptoms. The pilot and feasibility study will contribute to refining recommendations for implementation of mhGAP and other mental health services in primary healthcare settings in low-resource health systems. The pilot c-RCT findings will inform an effectiveness trial of RESHAPE to advance the evidence-base for optimal approaches to training and supervision for non-specialist providers. ClinicalTrials.gov identifier, NCT02793271.

Female United States Air Force (USAF) pilots: themes, challenges, and possible solutions.

PubMed

McGlohn, S E; King, R E; Butler, J W; Retzlaff, P D

1997-02-01

Identification of stresses of mixed-gender squadrons, attention to the psychological concerns of pilots in combat, and recognition of the difficulties of balancing a career and family are important in today's United States Air Force (USAF). What qualities are desirable in male and female pilots in combat situations, how do men and women view their career and family goals, and how do men and women work together in day-to-day squadron activities versus deployment and combat situations? A semi-structured clinical interview sought in formation about personal/family health, squadron relationships, and career/deployment stresses. The interview covered the effect of grounding for more than 30 d, motivation to fly, health decrements due to aircraft design, teamwork difficulties and blocks to success, career demands, combat and prisoner of war (POW) concerns, stress and coping styles, flying goals, and family/health concerns. There were 114 (64 male and 50 female) pilots who participated in the study. The majority of male pilots interviewed asserted that they would be more protective of a woman in combat than a man and were concerned about their reaction to a female POW. Many women were concerned about being used to exploit men in a POW camp. The majority of pilots believed women were well integrated into their squadrons. Those interviewed reported that the squadron members with the most difficulty dealing with women were older males, including enlisted crew and some commanders. The information gained from this study will assist the USAF in understanding and coping with the psychological stresses associated with combat, deployment, and mixed-gender squadrons.

Development and Feasibility of a Structured Goals of Care Communication Guide.

PubMed

Bekelman, David B; Johnson-Koenke, Rachel; Ahluwalia, Sangeeta C; Walling, Anne M; Peterson, Jamie; Sudore, Rebecca L

2017-09-01

Discussing goals of care and advance care planning is beneficial, yet how to best integrate goals of care communication into clinical care remains unclear. To develop and determine the feasibility of a structured goals of care communication guide for nurses and social workers. Developmental study with providers in an academic and Veterans Affairs (VA) health system (n = 42) and subsequent pilot testing with patients with chronic obstructive pulmonary disease or heart failure (n = 15) and informal caregivers (n = 4) in a VA health system. During pilot testing, the communication guide was administered, followed by semistructured, open-ended questions about the content and process of communication. Changes to the guide were made iteratively, and subsequent piloting occurred until no additional changes emerged. Provider and patient feedback to the communication guide. Iterative input resulted in the goals of care communication guide. The guide included questions to elicit patient understanding of and attitudes toward the future of illness, clarify values and goals, identify end-of-life preferences, and agree on a follow-up plan. Revisions to guide content and phrasing continued during development and pilot testing. In pilot testing, patients validated the importance of the topic; none said the goals of care discussion should not be conducted. Patients and informal caregivers liked the final guide length (∼30 minutes), felt it flowed well, and was clear. In this developmental and pilot study, a structured goals of care communication guide was iteratively designed, implemented by nurses and social workers, and was feasible based on administration time and acceptability by patients and providers.

Personalized Oncology Through Integrative High-Throughput Sequencing: A Pilot Study

PubMed Central

Roychowdhury, Sameek; Iyer, Matthew K.; Robinson, Dan R.; Lonigro, Robert J.; Wu, Yi-Mi; Cao, Xuhong; Kalyana-Sundaram, Shanker; Sam, Lee; Balbin, O. Alejandro; Quist, Michael J.; Barrette, Terrence; Everett, Jessica; Siddiqui, Javed; Kunju, Lakshmi P.; Navone, Nora; Araujo, John C.; Troncoso, Patricia; Logothetis, Christopher J.; Innis, Jeffrey W.; Smith, David C.; Lao, Christopher D.; Kim, Scott Y.; Roberts, J. Scott; Gruber, Stephen B.; Pienta, Kenneth J.; Talpaz, Moshe; Chinnaiyan, Arul M.

2012-01-01

Individual cancers harbor a set of genetic aberrations that can be informative for identifying rational therapies currently available or in clinical trials. We implemented a pilot study to explore the practical challenges of applying high-throughput sequencing in clinical oncology. We enrolled patients with advanced or refractory cancer who were eligible for clinical trials. For each patient, we performed whole-genome sequencing of the tumor, targeted whole-exome sequencing of tumor and normal DNA, and transcriptome sequencing (RNA-Seq) of the tumor to identify potentially informative mutations in a clinically relevant time frame of 3 to 4 weeks. With this approach, we detected several classes of cancer mutations including structural rearrangements, copy number alterations, point mutations, and gene expression alterations. A multidisciplinary Sequencing Tumor Board (STB) deliberated on the clinical interpretation of the sequencing results obtained. We tested our sequencing strategy on human prostate cancer xenografts. Next, we enrolled two patients into the clinical protocol and were able to review the results at our STB within 24 days of biopsy. The first patient had metastatic colorectal cancer in which we identified somatic point mutations in NRAS, TP53, AURKA, FAS, and MYH11, plus amplification and overexpression of cyclin-dependent kinase 8 (CDK8). The second patient had malignant melanoma, in which we identified a somatic point mutation in HRAS and a structural rearrangement affecting CDKN2C. The STB identified the CDK8 amplification and Ras mutation as providing a rationale for clinical trials with CDK inhibitors or MEK (mitogenactivated or extracellular signal–regulated protein kinase kinase) and PI3K (phosphatidylinositol 3-kinase) inhibitors, respectively. Integrative high-throughput sequencing of patients with advanced cancer generates a comprehensive, individual mutational landscape to facilitate biomarker-driven clinical trials in oncology. PMID:22133722

Stress predicts brain changes in children: a pilot longitudinal study on youth stress, posttraumatic stress disorder, and the hippocampus.

PubMed

Carrion, Victor G; Weems, Carl F; Reiss, Allan L

2007-03-01

Does stress damage the brain? Studies of adults with posttraumatic stress disorder have demonstrated smaller hippocampal volumes when compared with the volumes of adults with no posttraumatic stress disorder. Studies of children with posttraumatic stress disorder have not replicated the smaller hippocampal findings in adults, which suggests that smaller hippocampal volume may be caused by neurodevelopmental experiences with stress. Animal research has demonstrated that the glucocorticoids secreted during stress can be neurotoxic to the hippocampus, but this has not been empirically demonstrated in human samples. We hypothesized that cortisol volumes would predict hippocampal volume reduction in patients with posttraumatic symptoms. We report data from a pilot longitudinal study of children (n = 15) with history of maltreatment who underwent clinical evaluation for posttraumatic stress disorder, cortisol, and neuroimaging. Posttraumatic stress disorder symptoms and cortisol at baseline predicted hippocampal reduction over an ensuing 12- to 18-month interval. Results from this pilot study suggest that stress is associated with hippocampal reduction in children with posttraumatic stress disorder symptoms and provide preliminary human evidence that stress may indeed damage the hippocampus. Additional studies seem to be warranted.

INfluence of Successful Periodontal Intervention in REnal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial.

PubMed

Sharma, Praveen; Cockwell, Paul; Dietrich, Thomas; Ferro, Charles; Ives, Natalie; Chapple, Iain L C

2017-11-13

Patients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing comorbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both. This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD. This pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n = 30) or treatment at a delay of 12 months (n = 30). Patients will be excluded if they have reached end-stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an outpatient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed-treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients' treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient-reported outcomes will be collected at each time point. This pilot randomised controlled trial will investigate the viability of undertaking a larger-scale study investigating the effect of treating periodontitis and maintaining periodontal health on cardio-renal outcomes in patients with CKD. National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID: 18458), ID: ISRCTN10227738 . Registered retrospectively to both registers on 23 April 2015.

Medication reconciliation in pediatric cardiology performed by a pharmacy technician: a prospective cohort comparison study.

PubMed

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model.

Medication Reconciliation in Pediatric Cardiology Performed by a Pharmacy Technician: A Prospective Cohort Comparison Study

PubMed Central

Chan, Carol; Woo, Renée; Seto, Winnie; Pong, Sandra; Gilhooly, Tessie; Russell, Jennifer

2015-01-01

Background: Medication reconciliation reduces potential medication discrepancies and adverse drug events. The role of pharmacy technicians in obtaining best possible medication histories (BPMHs) and performing reconciliation at the admission and transfer interfaces of care for pediatric patients has not been described. Objectives: To compare the completeness and accuracy of BPMHs and reconciliation conducted by a pharmacy technician (pilot study) and by nurses and/or pharmacists (baseline). The severity of identified unintentional discrepancies was rated to determine their clinical importance. Methods: This prospective cohort comparison study involved patients up to 18 years of age admitted to and/or transferred between the Cardiology ward and the Cardiac Critical Care Unit of a pediatric tertiary care teaching hospital. A pharmacy resident conducted two 3-week audits: the first to assess the completeness and accuracy of BPMHs and reconciliation performed by nurses and/or pharmacists and the second to assess the completeness and accuracy of BPMHs and reconciliation performed by a pharmacy technician. Results: The total number of patients was 38 in the baseline phase and 46 in the pilot period. There were no statistically significant differences between the baseline and pilot audits in terms of completion of BPMH (82% [28/34] versus 78% [21/27], p = 0.75) or completion of reconciliation (70% [23/33] versus 75% [15/20], p = 0.76) within 24 h of admission. Completeness of transfer reconciliation was significantly higher during the pilot study than at baseline (91% [31/34] versus 61% [11/18], p = 0.022). No significant differences between the baseline and pilot audits were found in the proportions of patients with at least one BPMH discrepancy (38% [13/34] versus 22% [6/27], p = 0.27), at least one unintentional discrepancy upon admission (21% [7/33] versus 10% [2/20], p = 0.46), or at least one unintentional discrepancy at the transfer interface (6% [1/18] versus 3% [1/34], p = 0.58). None of the 16 unintentional discrepancies were rated as causing severe patient discomfort or clinical deterioration. Conclusions: A trained pharmacy technician can perform admission and transfer medication reconciliation for pediatric patients with completeness and accuracy comparable to those of nurses and pharmacists. Future studies should explore the sustainability and cost-effectiveness of this practice model. PMID:25762814

ACORN's Accelerated Income Redistribution Project: A Program Evaluation

ERIC Educational Resources Information Center

Brooks, Fred; Russell, Daniel; Fisher, Robert

2006-01-01

Objective: This study evaluated the Association of Community Organizations for Reform Now's (ACORN) efforts to increase the uptake of families claiming the earned income tax credit through door-to-door canvassing and managing free tax preparation clinics in three pilot cities. Method: The mixed-method program evaluation included administrative…

Vitamin D-mediated calcium absorption in patients with clinically stable Crohn's disease: a pilot study

USDA-ARS?s Scientific Manuscript database

Vitamin D is the critical hormone for intestinal absorption of calcium. Optimal calcium absorption is important for proper mineralization of bone in the prevention of osteoporosis and osteoporotic fractures, among other important functions. Diseases associated with gut inflammation, such as Crohn's ...

Untoward effects of a sympathomimetic amine. [decongestant produced arrhythmia in pilot

NASA Technical Reports Server (NTRS)

Billings, C. E.; Ralston, R. H.; Hare, D. E.

1974-01-01

Presentation and discussion of a clinical report describing asymptomatic multifocal ventricular premature contractions in a professional pilot. He had been taking heavy doses of a systemic decongestant agent, pseudoephedrine, prescribed by a physician. He was taken off the medication, and over the next few days the PVCs became less frequent, then disappeared. It is pointed out that physician's instructions to pilots must be given with the realization that some airmen may follow the instructions too zealously in an attempt to remain on flying status.

Patient participation in cancer clinical trials: A pilot test of lay navigation.

PubMed

Cartmell, Kathleen B; Bonilha, Heather S; Matson, Terri; Bryant, Debbie C; Zapka, Jane G; Bentz, Tricia A; Ford, Marvella E; Hughes-Halbert, Chanita; Simpson, Kit N; Alberg, Anthony J

2016-08-15

Clinical trials (CT) represent an important treatment option for cancer patients. Unfortunately, patients face challenges to enrolling in CTs, such as logistical barriers, poor CT understanding and complex clinical regimens. Patient navigation is a strategy that may help to improve the delivery of CT education and support services. We examined the feasibility and initial effect of one navigation strategy, use of lay navigators. A lay CT navigation intervention was evaluated in a prospective cohort study among 40 lung and esophageal cancer patients. The intervention was delivered by a trained lay navigator who viewed a 17-minute CT educational video with each patient, assessed and answered their questions about CT participation and addressed reported barriers to care and trial participation. During this 12-month pilot project, 85% (95% CI: 72%-93%) of patients eligible for a therapeutic CT consented to participate in the CT navigation intervention. Among navigated patients, CT understanding improved between pre- and post-test (means 3.54 and 4.40, respectively; p-value 0.004), and 95% (95% CI: 82%-98%) of navigated patients consented to participate in a CT. Navigated patients reported being satisfied with patient navigation services and CT participation. In this formative single-arm pilot project, initial evidence was found for the potential effect of a lay navigation intervention on CT understanding and enrollment. A randomized controlled trial is needed to examine the efficacy of the intervention for improving CT education and enrollment.

Crosstalk between oral and general health status in e-smokers.

PubMed

Tatullo, Marco; Gentile, Stefano; Paduano, Francesco; Santacroce, Luigi; Marrelli, Massimo

2016-12-01

Electronic cigarette (e-cigarette) simulates the act of tobacco smoking by vaporizing a mixture of propylene glycol, nicotine, and flavoring agents. e-cigarette has been proposed as a product able to aid to stop smoking. The aim of the study is to verify the clinical variations of periodontal health induced by e-cigarettes use and, moreover, to investigate about the awareness of the e-smokers about their health variations and about their hypothetical need to turn back to smoke combustible cigarettes.This clinical observational pilot study involved 110 out of 350 smokers, who switched to e-cigarette. Patients were subjected to oral examinations. A questionnaire to self-assess the variations of some parameters of general health, and to self-assess the need to smoke combustible cigarettes, was distributed to such subjects involved in the study.At the end of the study, we registered a progressive improvement in the periodontal indexes, as well as in the general health perception. Finally, many patients reported an interesting reduction in the need to smoke.In the light of this pilot study, the e-cigarette can be considered as a valuable alternative to tobacco cigarettes, but with a positive impact on periodontal and general health status.

How we developed and piloted an electronic key features examination for the internal medicine clerkship based on a US national curriculum.

PubMed

Bronander, Kirk A; Lang, Valerie J; Nixon, L James; Harrell, Heather E; Kovach, Regina; Hingle, Susan; Berman, Norman

2015-01-01

Key features examinations (KFEs) have been used to assess clinical decision making in medical education, yet there are no reports of an online KFE-based on a national curriculum for the internal medicine clerkship. What we did: The authors developed and pilot tested an electronic KFE based on the US Clerkship Directors in Internal Medicine core curriculum. Teams, with expert oversight and peer review, developed key features (KFs) and cases. The exam was pilot tested at eight medical schools with 162 third and fourth year medical students, of whom 96 (59.3%) responded to a survey. While most students reported that the exam was more difficult than a multiple choice question exam, 61 (83.3%) students agreed that it reflected problems seen in clinical practice and 51 (69.9%) students reported that it more accurately assessed the ability to make clinical decisions. The development of an electronic KFs exam is a time-intensive process. A team approach offers built-in peer review and accountability. Students, although not familiar with this format in the US, recognized it as authentically assessing clinical decision-making for problems commonly seen in the clerkship.

Comparison of midwifery care to medical care in hospitals in the Quebec pilot projects study: clinical indicators. L'Equipe dEvaluation des Projets-Pilotes Sages-Femmes.

PubMed

Fraser, W; Hatem-Asmar, M; Krauss, I; Maillard, F; Bréart, G; Blais, R

2000-01-01

The purpose of this study was to compare indicators of process and outcome of midwifery services provided in the Quebec pilot projects to those associated with standard hospital-based medical services. Women receiving each type of care (961 per group) were matched on the basis of socio-demographic characteristics and level of obstetrical risk. We found midwifery care to be associated with less obstetrical intervention and a reduction in selected indicators of maternal morbidity (caesarean section and severe perineal injury). For neonatal outcome indicators, midwifery care was associated with a mixture of benefits and risks: fewer babies with preterm birth and low birthweight, but a trend toward a higher stillbirth ratio and more frequent requirement for neonatal resuscitation. The study design does not permit to conclude that the associations were causal in nature. However, the high stillbirth rate observed in the group of women who were selected for midwife care raises concerns both regarding the appropriateness of the screening procedures for admission to such care and regarding the quality of care itself.

A pilot study regarding basic knowledge of "cortical visual impairment in children" among ophthalmologists.

PubMed

Maitreya, Amit; Rawat, Darshika; Pandey, Shubham

2018-02-01

A pilot study was done to evaluate knowledge regarding "cortical visual impairment (CVI) in children" among ophthalmologists. This study was conducted during the annual conference of a zonal ophthalmological society. All ophthalmologists who attended the conference were requested to participate in this study. Those who agreed were given a validated questionnaire to assess knowledge regarding CVI. Cronbach's alpha of the questionnaire was 0.6. Participants were asked to respond to multiple choice questions by choosing the single best option. The responses obtained were then evaluated. The total number of registered delegates in the conference was 448. A total of 103 ophthalmologists showed interest to participate in the study with a response rate of 22.9%. Only 89/103 interested delegates were included in the study as remaining were unaware of CVI. No participant gave correct answers to all questions. Although more than 80% of them knew the most common association (87%) and site of pathology (84%), only 52% were sure about clinical features and even lesser respondents (39%) knew that magnetic resonance imaging is the correct investigation of choice. The majority responded correctly that these children need eye examination (89%) and can be managed by rehabilitation through multidisciplinary approach (82%), but only 58% could recognize differential diagnoses and had a correct idea regarding the prognosis of CVI. There was no correlation between the number of patients diagnosed per month by the respondent with knowledge of the disease. In this pilot study, ophthalmologists were found to have limited knowledge regarding clinical features, investigation, differential diagnosis, and visual prognosis of CVI in children. There is a need to improve awareness regarding CVI among ophthalmologists.

A pilot study regarding basic knowledge of “cortical visual impairment in children” among ophthalmologists

PubMed Central

Maitreya, Amit; Rawat, Darshika; Pandey, Shubham

2018-01-01

Purpose: A pilot study was done to evaluate knowledge regarding “cortical visual impairment (CVI) in children” among ophthalmologists. Methods: This study was conducted during the annual conference of a zonal ophthalmological society. All ophthalmologists who attended the conference were requested to participate in this study. Those who agreed were given a validated questionnaire to assess knowledge regarding CVI. Cronbach's alpha of the questionnaire was 0.6. Participants were asked to respond to multiple choice questions by choosing the single best option. The responses obtained were then evaluated. Results: The total number of registered delegates in the conference was 448. A total of 103 ophthalmologists showed interest to participate in the study with a response rate of 22.9%. Only 89/103 interested delegates were included in the study as remaining were unaware of CVI. No participant gave correct answers to all questions. Although more than 80% of them knew the most common association (87%) and site of pathology (84%), only 52% were sure about clinical features and even lesser respondents (39%) knew that magnetic resonance imaging is the correct investigation of choice. The majority responded correctly that these children need eye examination (89%) and can be managed by rehabilitation through multidisciplinary approach (82%), but only 58% could recognize differential diagnoses and had a correct idea regarding the prognosis of CVI. There was no correlation between the number of patients diagnosed per month by the respondent with knowledge of the disease. Conclusion: In this pilot study, ophthalmologists were found to have limited knowledge regarding clinical features, investigation, differential diagnosis, and visual prognosis of CVI in children. There is a need to improve awareness regarding CVI among ophthalmologists. PMID:29380776

From Survivor to Thriver: A Pilot Study of an Online Program for Rape Victims

PubMed Central

Littleton, Heather; Buck, Katherine; Rosman, Lindsey; Grills-Taquechel, Amie

2013-01-01

Approximately 15% to 20% of women have been victims of rape and close to a third report current rape-related PTSD or clinically significant depression or anxiety. Unfortunately, very few distressed rape victims seek formal help. This suggests a need to develop alternative ways to assist the many distressed victims of sexual violence. Online treatment programs represent a potentially important alternative strategy for reaching such individuals. The current paper describes a pilot evaluation of an online, therapist-facilitated, self-paced cognitive behavioral program for rape victims. Five college women with current rape-related PTSD were recruited to complete the From Survivor to Thriver (S to T) program in a lab setting over the course of 7 weeks. After completing the program, 4 participants reported clinically significant reductions in PTSD symptoms and no longer met criteria for PTSD. All participants reported clinically significant reductions in vulnerability fears and 4 reported significant reductions in negative trauma-related cognitions. Implications of the results for further development of the S to T program and how clinicians could utilize this program in treating rape-related PTSD are discussed. PMID:24009410

Transcranial direct current stimulation associated with gait training in Parkinson's disease: A pilot randomized clinical trial.

PubMed

Costa-Ribeiro, Adriana; Maux, Ariadne; Bosford, Thamyris; Aoki, Yumi; Castro, Rebeca; Baltar, Adriana; Shirahige, Lívia; Moura Filho, Alberto; Nitsche, Michael A; Monte-Silva, Kátia

2017-04-01

The aim of this study is to investigate the effects of transcranial direct current stimulation (tDCS) combined with cueing gait training (CGT) on functional mobility in patients with Parkinson´s disease (PD). A pilot double-blind controlled, randomized clinical trial was conducted with 22 patients with PD assigned to the experimental (anodal tDCS plus CGT) and control group (sham tDCS plus CGT). The primary outcome (functional mobility) was assessed by 10-m walk test, cadence, stride length, and Timed Up and Go test. Motor impairment, bradykinesia, balance, and quality of life were analyzed as secondary outcomes. Minimal clinically important differences (MCIDs) were observed when assessing outcome data. Both groups demonstrated similar gains in all outcome measures, except for the stride length. The number of participants who showed MCID was similar between groups. The CGT provided many benefits to functional mobility, motor impairment, bradykinesia, balance, and quality of life. However, these effect magnitudes were not influenced by stimulation, but tDCS seems to prolong the effects of cueing therapy on functional mobility.

A follow-up study of heroin addicts (VEdeTTE2): study design and protocol

PubMed Central

Vigna-Taglianti, Federica D; Mathis, Federica; Diecidue, Roberto; Burroni, Paola; Iannaccone, Antonio; Lampis, Fabio; Zuccaro, Piergiorgio; Pacifici, Roberta; Versino, Elisabetta; Davoli, Marina; Faggiano, Fabrizio

2007-01-01

Background In Italy, a large cohort study (VEdeTTE1) was conducted between 1998–2001 to evaluate the effectiveness of treatments in reducing mortality and increasing treatment retention among heroin addicts. The follow-up of this cohort (VEdeTTE2) was designed to evaluate the effectiveness of treatments on long-term outcomes, such as rehabilitation and social re-integration. The purpose of this paper is to describe the protocol of the VEdeTTE2 study, and to present the results of the pilot study carried out to assess the feasibility of the study and to improve study procedures. Methods The source population for the VEdeTTE2 study was the VEdeTTE1 cohort, from which a sample of 2,200 patients, traced two or more years after enrolment in the cohort, were asked to participate. An interview investigates drug use; overdose; family and social re-integration. Illegal activity are investigated separately in a questionnaire completed by the patient. Patients are also asked to provide a hair sample to test for heroin and cocaine use. Information on treatments and HIV, HBV and HCV morbidity are obtained from clinical records. A pilot phase was planned and carried out on 60 patients. Results The results of the pilot phase pointed out the validity of the procedures designed to limit attrition: the number of traced subjects was satisfactory (88%). Moreover, the pilot phase was very useful in identifying possible causes of delays and attrition, and flaws in the instruments. Improvements to the procedures and the instruments were subsequently implemented. Sensitivity of the biological test was quite good for heroin (78%) but lower for cocaine (42.3%), highlighting the need to obtain a hair sample from all patients. Conclusion In drug addiction research, studies investigating health status and social re-integration of subjects at long-term follow-up are lacking. The VEdeTTE2 study aims to investigate these outcomes at long-term follow-up. Results of the pilot phase underline the importance of the pilot phase when planning a follow-up study. PMID:17362515

Piloting an information literacy program for staff nurses: lessons learned.

PubMed

Rosenfeld, Peri; Salazar-Riera, Noraliza; Vieira, Dorice

2002-01-01

Intrinsic to all models of evidence-based practice is the need for information literacy and the critical assessment of information. As part of a house-wide evidence-based practice initiative, the objective of this pilot project was to develop the information literacy skills of staff nurses to increase their ability to find and assess available electronic resources for clinical decision making. An intensive care unit was chosen to pilot a unit-based approach to educate staff nurses to perform patient care-related electronic literature searches. An additional goal was to determine the effectiveness of unit-based training sessions on the frequency and quality of electronic literature searches by participating nurses. In addition to the unit-based instruction, nursing and library staff collaborated to develop a Web-based tutorial to supplement and reinforce the content of the training sessions. A pretest-post-test design was used to evaluate the initiative and to assess the effect of the educational intervention over time. Among the lessons learned from this pilot study was that unit-based instruction presents significant obstacles for effective learning of new technological skills for staff nurses.

A Pilot Study of a Culturally Targeted Video Intervention to Increase Participation of African American Patients in Cancer Clinical Trials

PubMed Central

Libin, Alexander V.; Wang, Hong; Swain, Sandra M.

2012-01-01

Purpose. Barriers to clinical trial participation among African American cancer patients are well characterized in the literature. Attitudinal barriers encompassing fear, distrust, and concerns about ethical misconduct are also well documented. To increase trial accrual, these attitudes must be adequately addressed, yet there remains a lack of targeted interventions toward this end. We developed a 15-minute culturally targeted video designed to impact six specific attitudes of African American cancer patients toward therapeutic trials. We conducted a pilot study to test in the first such intervention to increase intention to enroll. Patients and Methods. The primary study outcome was self-reported likelihood to participate in a therapeutic trial. Using a mixed methods approach, we developed the Attitudes and Intention to Enroll in Therapeutic Clinical Trials (AIET) instrument, a 30-item questionnaire measuring six attitudinal barriers to African American trial participation. We enrolled 108 eligible active treatment patients at a large urban cancer institute. McNemar's test for matched pairs was used to assess changes in attitudes and likelihood to enroll in a clinical trial at baseline and immediately after the video. Pre- and post-video AIET summative scores were analyzed by paired t-test for each attitudinal barrier. Results. Patients' likelihood of enrolling in a clinical trial significantly increased post-video with 36% of the sample showing positive changes in intention [McNemar's χ2 = 33.39, p < .001]. Paired t-tests showed significant changes in all six attitudinal barriers measured via AIET summative scores from pre- to post-video. Conclusion. These data suggest utility of our video for increasing African American participation in clinical trials. PMID:22639112

Medical student, nursing student, and non-health care respondents' implicit attitudes toward doctors and patients: Development and a pilot study of a new implicit attitudes test (IAT)

PubMed Central

Mazouni, Abdelhamid

2017-01-01

Introduction Medical educators have been concerned that medical students may decline in empathy for patients during the course of their training, based on studies measuring clinical empathy using psychometrically strong self-report measures. Clinical empathy is a complex construct, incorporating attitudes toward patients but also other components, such as professional detachment. Triangulation of extant measures with instruments based on nonreactive methods could provide a better understanding of whether and how physician attitudes toward patients may be changing during training. We sought to develop and pilot-test such a nonreactive method. Methods We develop variations of an implicit association test (IAT) designed to measure attitudes toward physicians and patients based on speed of reaction to images of actors and positive and negative words. In the IATs, the same actors are photographed as doctors, clinic outpatients, hospitalized inpatients, and as a “general public” control. We examine preliminary evidence for their validity by collecting pilot data from internet participants (not involved in the health professions), medical students, and nursing students. Results Internet participants (n = 314) and nursing students (n = 31) had more negative associations (IAT scores) with doctors than did medical students (n = 89); nursing students and female internet participants had more positive associations with hospitalized patients than did medical students and male internet participants. Medical students’ associations with hospitalized patients varied by year of training. Discussion This IAT may provide insight into implicit attitudes among those who enter training for the health profession and changes in those attitudes that may be inculcated during that training. PMID:28813524

Evaluation of a pilot hypertension management programme for Guatemalan adults.

PubMed

Mendoza Montano, Carlos; Fort, Meredith; deRamirez, Miriam; Cruz, Judith; Ramirez-Zea, Manuel

2016-06-01

Corazón Sano y Feliz is a hypertension management intervention developed to address deficiencies in the management of hypertensive patients in Guatemala. From 2007 to 2009, Corazón Sano y Feliz was pilot-tested in the community of Mixco. Corazón Sano y Feliz comprises a clinical risk assessment and treatment component implemented primarily by nurses, and a health education component implemented by community health workers. To accomplish our secondary objective of determining Corazon Sano y Feliz's potential for change at the patient level, we implemented a one-group pretest-posttest study design to examine changes in clinical measures, knowledge and practices between baseline and the end of the 6-month intervention. Two nurses and one physician set up a hypertension clinic to manage patients according to risk level. Twenty-nine community health workers were trained in CVD risk reduction and health promotion and in turn led six educational sessions for patients. Comparing baseline and 6-month measures, the intervention achieved significant improvements in mean knowledge and behaviour (increase from 54.6 to 59.1 out of a possible 70 points) and significant reductions of mean systolic and diastolic blood pressure (27.2 and 7.7 mmHg), body mass index (from 26.5 to 26.2 kg/m(2)) and waist circumference (89.6-88.9 cm). In this pilot study we obtained preliminary evidence that this community-oriented hypertension management and health promotion intervention model was feasible and achieved significant reduction in risk factors. If scaled up, this intervention has the potential to substantially reduce CVD burden. © The Author 2015. Published by Oxford University Press. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

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).

Template-Directed Instrumentation Reduces Cost and Improves Efficiency for Total Knee Arthroplasty: An Economic Decision Analysis and Pilot Study.

PubMed

McLawhorn, Alexander S; Carroll, Kaitlin M; Blevins, Jason L; DeNegre, Scott T; Mayman, David J; Jerabek, Seth A

2015-10-01

Template-directed instrumentation (TDI) for total knee arthroplasty (TKA) may streamline operating room (OR) workflow and reduce costs by preselecting implants and minimizing instrument tray burden. A decision model simulated the economics of TDI. Sensitivity analyses determined thresholds for model variables to ensure TDI success. A clinical pilot was reviewed. The accuracy of preoperative templates was validated, and 20 consecutive primary TKAs were performed using TDI. The model determined that preoperative component size estimation should be accurate to ±1 implant size for 50% of TKAs to implement TDI. The pilot showed that preoperative template accuracy exceeded 97%. There were statistically significant improvements in OR turnover time and in-room time for TDI compared to an historical cohort of TKAs. TDI reduces costs and improves OR efficiency. Copyright © 2015 Elsevier Inc. All rights reserved.

Neurofeedback as a treatment for major depressive disorder--a pilot study.

PubMed

Peeters, Frenk; Oehlen, Mare; Ronner, Jacco; van Os, Jim; Lousberg, Richel

2014-01-01

There is growing interest in neurofeedback as a treatment for major depressive disorder. Reduction of asymmetry of alpha-activity between left and right prefrontal areas with neurofeedback has been postulated as effective in earlier studies. Unfortunately, methodological shortcomings limit conclusions that can be drawn from these studies. In a pilot-study, we investigated the effectiveness of reduction of asymmetry of alpha-activity with neurofeedback in depressed participants with the use of a stringent methodological approach. Nine participants meeting DSM-IV criteria for major depressive disorder were treated with a maximum of 30 neurofeedback-sessions, aimed at reducing asymmetry of alpha-activity, over a 10-week period. No changes in the use of antidepressants were allowed 6 weeks before and during the intervention. Changes in depressive symptomatology were assessed with the Quick Inventory of Depressive Symptoms, self-report version. We observed response in 1 and remission in 4 out of a total of 9 participants. The effectiveness appeared largest in female participants. The mean asymmetry of alpha-activity decreased significantly over sessions in a quadratic fashion. This decrease was associated with clinical response. This pilot study suggests that neurofeedback aimed at a reduction of frontal asymmetry of alpha-activity may be effective as a treatment for depression. However, this was an open label pilot study. Non-specific effects of the procedure and/or a beneficial natural course may have confounded the results. Randomized controlled trials will have to establish the efficacy of neurofeedback for depression. Nederlands Trial Register NTR1629.

Modafinil treatment for fatigue in HIV+ patients: a pilot study.

PubMed

Rabkin, Judith G; McElhiney, Martin C; Rabkin, Richard; Ferrando, Stephen J

2004-12-01

Fatigue is widespread among human immunodeficiency virus-positive (HIV+) patients, yet few studies have assessed effective treatments. The authors conducted a pilot study to evaluate the efficacy of modafinil for fatigue in this clinical population. Response was evaluated after a 4-week open-label trial. Data were collected from February 2003 through January 2004. Responders were offered 8 additional weeks of modafinil. Inclusion criteria included written approval from the primary care physician, clinically significant fatigue, current use of anti-retroviral medications, and the absence of treatable medical conditions known to cause fatigue. Exclusion criteria included untreated major depression and current substance abuse. Major outcome measures were the Fatigue Severity Scale, Chalder Fatigue Scale, Hamilton Rating Scale for Depression, Beck Depression Inventory, and neuropsychological tests assessing verbal memory, speed of processing, and executive function. Immunologic and virologic measures were performed at baseline and week 4 to assess safety of treatment. All 30 patients who enrolled completed 4 weeks of treatment; 24 (80%) were rated as responders. Responders showed statistically significant improvement on all measures of fatigue, depressive symptoms, and executive function, while nonresponders did not. Mean values of CD4 cell count and HIV RNA viral load did not change. The most common side effect was headache, followed by irritability and feeling "hyper." This pilot study shows encouraging results for modafinil in alleviation of fatigue in HIV+ patients. In addition, depressive symptoms were substantially reduced. Improvements on measures of verbal memory and executive function were significant, but in the absence of a placebo control, the magnitude of effect due to practice cannot be determined.

A Survey of Medical Oncology Training in Australian Medical Schools: Pilot Study

PubMed Central

George, Mathew; Prawira, Amy

2017-01-01

Background Oncology is a rapidly evolving field with continuous advancements in the diagnosis and treatment of cancer. Therefore, it is important that medical students are provided with the knowledge and experience required to care for oncology patients and enable them to diagnose and manage toxicities of novel therapeutic agents. Objective This study was performed to understand the medical students’ perspective of the oncology education provided in universities across Australia and identify areas of education that could potentially be modified or improved to ultimately attract more students to a career in oncology. Methods This pilot cross-sectional study consisted of an 18-question survey that was submitted online to medical students in their final year and interns rotating to the Tamworth Hospital. Results The survey was completed by 94 fifth-year medical students and interns. Oncology was taught both theoretically and clinically for 68% (63/93) of participants, and 48% (44/92) had an exclusive oncology rotation. Both theoretical and clinical oncology assessments were conducted for only 21% (19/92) of participants. Overall, 42% (38/91) of participants were satisfied with their oncology education, and 78% (40/51) were dissatisfied with the number of oncology teaching hours. The importance of a career in oncology was rated as low by 46% (41/90) of participants. Conclusions This pilot study indicates that there are potential areas to improve oncology teaching in Australian universities. The majority of surveyed students were dissatisfied with the number of teaching hours they receive in oncology. More global assessment of students and/or interns from other Australian institutes may yield further useful information. PMID:29233799

The Effects of Compensatory Auditory Stimulation and High-Definition Transcranial Direct Current Stimulation (HD-tDCS) on Tinnitus Perception - A Randomized Pilot Study.

PubMed

Henin, Simon; Fein, Dovid; Smouha, Eric; Parra, Lucas C

2016-01-01

Tinnitus correlates with elevated hearing thresholds and reduced cochlear compression. We hypothesized that reduced peripheral input leads to elevated neuronal gain resulting in the perception of a phantom sound. The purpose of this pilot study was to test whether compensating for this peripheral deficit could reduce the tinnitus percept acutely using customized auditory stimulation. To further enhance the effects of auditory stimulation, this intervention was paired with high-definition transcranial direct current stimulation (HD-tDCS). A randomized sham-controlled, single blind study was conducted in a clinical setting on adult participants with chronic tinnitus (n = 14). Compensatory auditory stimulation (CAS) and HD-tDCS were administered either individually or in combination in order to access the effects of both interventions on tinnitus perception. CAS consisted of sound exposure typical to daily living (20-minute sound-track of a TV show), which was adapted with compressive gain to compensate for deficits in each subject's individual audiograms. Minimum masking levels and the visual analog scale were used to assess the strength of the tinnitus percept immediately before and after the treatment intervention. CAS reduced minimum masking levels, and visual analog scale trended towards improvement. Effects of HD-tDCS could not be resolved with the current sample size. The results of this pilot study suggest that providing tailored auditory stimulation with frequency-specific gain and compression may alleviate tinnitus in a clinical population. Further experimentation with longer interventions is warranted in order to optimize effect sizes.

Cosmic radiation and cancer: is there a link?

PubMed

Di Trolio, Rossella; Di Lorenzo, Giuseppe; Fumo, Bruno; Ascierto, Paolo A

2015-01-01

Cosmic radiation can cause genetic and cytogenetic damage. Certain occupations including airline pilots and cabin crew are acknowledged to have a greater exposure to cosmic radiation. In a systematic search of MEDLINE, performed from 1990 to 2014, we analyzed clinical studies using the keywords: cosmic radiation, cancer, chromosome aberration, pilots and astronauts. Increased incidence of skin cancers among airline cabin crew has been reported in a number of studies and appears to be the most consistent finding. However, as with other cancers, it is unclear whether increased exposure to cosmic radiation is a factor in the increased incidence or whether this can be explained by lifestyle factors. Further research is needed to clarify the risk of cancer in relation to cosmic radiation.

A pilot study measuring changes in student impressions before and after clinical training using a questionnaire based on the semantic differential technique.

PubMed

Tamura, Naomi; Terashita, Takayoshi; Ogasawara, Katsuhiko

2013-01-01

Students with a positive impression of their studies can become more motivated. This study measured the learning impact of clinical training by comparing student impressions before and after clinical training. The study included 32 students of radiological technology in their final year with the Division of Radiological Science and Technology, Department of Health Sciences, School of Medicine, Hokkaido University. To measure student impressions of x-ray examination training, we developed a questionnaire using the semantic differential technique. The resulting factor analysis identified 2 factors that accounted for 44.9% of the 10 bipolar adjective scales. Factor 1 represented a "resistance" impression of x-ray examination training, and factor 2 represented a "responsibility" impression. The differences in factor scores before and after the clinical training suggest that student impressions are affected by clinical training.

'Healthy gums do matter': A case study of clinical leadership within primary dental care.

PubMed

Moore, D; Saleem, S; Hawthorn, E; Pealing, R; Ashley, M; Bridgman, C

2015-09-25

The Health and Social Care Act 2012 heralded wide reaching reforms intended to place clinicians at the heart of the health service. For NHS general dental practice, the conduits for this clinical leadership are the NHS England local professional networks. In Greater Manchester, the local professional network has developed and piloted a clinician led quality improvement project: 'Healthy Gums DO Matter, a Practitioner's Toolkit'. Used as a case study, the project highlighted the following facilitators to clinical leadership in dentistry: supportive environment; mentoring and transformational leadership; alignment of project goals with national policy; funding allowance; cross-boundary collaboration; determination; altruism; and support from wider academic and specialist colleagues. Barriers to clinical leadership identified were: the hierarchical nature of healthcare, territorialism and competing clinical commitments.

Nursing students' early exposure to clinical practice: an innovation in curriculum development.

PubMed

Hoyles, A; Pollard, C; Lees, S; Glossop, D

2000-08-01

This paper describes a pilot study addressing issues surrounding the balance and status given to both theory and practice in the foundation part of a pre-registration programme. Contemporary thinking seems to suggest that there is a need to reverse recent trends which have placed an emphasis on theory. To facilitate this a framework for clinical learning was adapted to guide students' early exposure to clinical practice. The focus was to develop the students' observational and reflective skills whilst also providing the students with a frame of reference within which they could explore their theoretical studies. The information and experiences gained as a result of this study have led to the integration of an Orientation Framework to support students' early clinical experiences in a pre-registration programme.

Empirically Assessing Participant Perceptions of the Research Experience in a Randomized Clinical Trial: The Women's Self-Defense Project as a Case Example.

PubMed

Weitlauf, Julie C; Ruzek, Josef I; Westrup, Darrah A; Lee, Tina; Keller, Jennifer

2007-06-01

A growing body of empirical literature has systematically documented the reactions to research participation among participants in traumafocused research. To date, the available data has generally presented an optimistic picture regarding participants' ability to tolerate and even find benefit from their participation. However, this literature has been largely limited to cross-sectional designs. No extant literature has yet examined the perceptions of participants with psychiatric illness who are participating in randomized clinical trials (RCTs) designed to evaluate the efficacy or effectiveness of novel trauma treatments. The authors posit that negative experiences of, or poor reactions to, the research experience in the context of a trauma-focused RCT may elevate the risk of participation. Indeed, negative reactions may threaten to undermine the potential therapeutic gains of participants and promoting early drop out from the trial. Empirically assessing reactions to research participation at the pilot-study phase of a clinical trial can both provide investigators and IRB members alike with empirical evidence of some likely risks of participation. In turn, this information can be used to help shape the design and recruitment methodology of the full-scale trial. Using data from the pilot study of the Women's Self-Defense Project as a case illustration, we provide readers with concrete suggestions for empirically assessing participants' perceptions of risk involved in their participation in behaviorally oriented clinical trials.

A Pilot Study to Evaluate Effectiveness of INR Self-Testing in Elderly Patients.

PubMed

Pogge, Elizabeth

2015-12-01

To determine if international normalized ratio (INR) patient self-testing (PST) resulted in an increased time in therapeutic range (TTR) in an elderly population when compared with clinic testing over a six-month period. A pilot study and retrospective chart review from August 2010 to August 2014. Ambulatory, anticoagulation clinic with two locations in Sun City West and Peoria, Arizona. Of 91 patients, the data of 20 patients who were 65 years of age or older and had at least six months of pre- and post-PST INR data were extracted and analyzed. The primary outcome evaluated improvement of TTR during post-PST in elderly patients compared with clinic management over a six-month period. Secondary outcomes assessed patients' satisfaction with PST and identified barriers to PST. The post-PST mean TTR significantly increased to 73% from 63.6% for the first six months of PST (P = 0.04). Participants were satisfied with PST, with an average score ranging from 4.6 to 5 on a Likert scale of 1 to 5 on 10 satisfaction survey questions. Cost was identified as the most common barrier to PST, with 43% of patients not participating in PST because of financial burden. With appropriate screening and training, PST is associated with improved TTRs and higher patient satisfaction in elderly patients when compared with clinic testing. Barriers identified to PST include cost, the complex process, and noncompliance.

Dexpanthenol enemas in ulcerative colitis: a pilot study.

PubMed

Loftus, E V; Tremaine, W J; Nelson, R A; Shoemaker, J D; Sandborn, W J; Phillips, S F; Hasan, Y

1997-07-01

To test the hypothesis that topical administration of pantothenic acid, a precursor of coenzyme A, might result in increased tissue levels of coenzyme A, improvement of fatty acid oxidation, and amelioration of ulcerative colitis. In an open-label pilot study, three patients with active left-sided ulcerative colitis received nightly enemas that contained 1,000 mg of dexpanthenol for 4 weeks. Before and after the study, patients submitted stool specimens for short-chain fatty acid analysis and urine collections for measurement of pantothenic acid and dicarboxylic acids; they also underwent flexible sigmoidoscopy for procurement of biopsy specimens for histologic examination and measurement of colonic coenzyme A activity. A clinical disease activity index and histologic disease activity index were used to assess response. Despite increases in urinary pantothenic acid, no significant changes were found in colonic tissue coenzyme A concentrations, fecal short-chain fatty acid concentrations, or urinary dicarboxylic acid concentrations. Moreover, no significant changes in clinical or histologic disease activity were noted. Although stool frequency and rectal bleeding remained unchanged, all patients noted increased abdominal cramping, and one patient had an increased extent of disease. Topically administered dexpanthenol seems to be absorbed, but at the dose used in this study, it did not influence concentrations of colonic coenzyme A activity, fecal short-chain fatty acids, or clinical response in patients with active left-sided ulcerative colitis.

Pre-vaccination incidence of genital warts in 15-23-year-old women and men attending youth clinics in Stockholm, Sweden.

PubMed

Wikström, Arne; Brönnegård, Mikael; Cassel, Tobias; Young, Cecilia

2012-09-01

Human papillomavirus (HPV) vaccines were introduced to the market in 2006 and 2007. The present pilot study was designed to examine the incidence of genital warts in the population up to 23 y of age in the county of Stockholm before the start of mass HPV vaccination. Data from the electronic health records of 9 youth clinics in the county of Stockholm were collected retrospectively for the y 2006-2008. In total, 49,985 patients visited the study youth clinics during 2006-2008. Of these, 1817 were denoted genital warts patients. An extrapolation of the study data was done in an attempt to estimate the annual number of genital warts cases in the full Stockholm County population aged 15-23 y. Results showed that there were approximately 1792 genital warts patients in the age group 15-23 y each year in Stockholm County. Female cases represented approximately 62% of all cases in the age group 15-23 y. The peak incidence was at around 20 y of age for females, while males had a more flattened peak incidence around 19-23 y of age. This pilot study demonstrates that, compared to other reported data, genital warts are at least as common in Sweden as in other countries among 15-23 y old females and males.

Homeopathy for attention-deficit/hyperactivity disorder: a pilot randomized-controlled trial.

PubMed

Jacobs, Jennifer; Williams, Anna-Leila; Girard, Christine; Njike, Valentine Yanchou; Katz, David

2005-10-01

The aim of this study was to carry out a preliminary trial evaluating the effectiveness of homeopathy in the treatment of attention-deficit/hyperactivity disorder (ADHD). This work was a randomized, double-blind, placebo-controlled trial. This study was conducted in a private homeopathic clinic in the Seattle metropolitan area. Subjects included children 6-12 years of age meeting Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for ADHD. Forty-three subjects were randomized to receive a homeopathic consultation and either an individualized homeopathic remedy or placebo. Patients were seen by homeopathic physicians every 6 weeks for 18 weeks. Outcome measures included the Conner's Global Index-Parent, Conner's Global Index- Teacher, Conner's Parent Rating Scale-Brief, Continuous Performance Test, and the Clinical Global Impression Scale. There were no statistically significant differences between homeopathic remedy and placebo groups on the primary or secondary outcome variables. However, there were statistically and clinically significant improvements in both groups on many of the outcome measures. This pilot study provides no evidence to support a therapeutic effect of individually selected homeopathic remedies in children with ADHD. A therapeutic effect of the homeopathic encounter is suggested and warrants further evaluation. Future studies should be carried out over a longer period of time and should include a control group that does not receive the homeopathic consultation. Comparison to conventional stimulant medication for ADHD also should be considered.

Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

PubMed Central

2013-01-01

Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

Prevalence of periodontopathogens and Candida spp. in smokers after nonsurgical periodontal therapy - a pilot study.

PubMed

Camargo, Gabriela Alessandra da Cruz Galhardo; Abreu, Mariana Gouvêa Latini; Cordeiro, Renata Dos Santos; Wenderoscky, Letícia de Farias; Duque, Cristiane

2016-08-22

This pilot study aimed to evaluate the influence of smoking on clinical and microbiological parameters after nonsurgical periodontal therapy. Forty-eight subjects were grouped into smokers (SM, n = 24) and nonsmokers (NS, n = 24) and paired according to gender, age, ethnicity, and periodontal status. Both groups received oral hygiene education and scaling and root planing. Clinical evaluation was performed using plaque index (PI), bleeding on probing (BOP), pocket probing depth (PPD), gingival recession (GR), and clinical attachment level (CAL) before instrumentation (baseline) and at 3 and 6 months. The prevalence of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Candida albicans, Candida glabrata, Candida tropicalis, and Candida dubliniensis in subgingival biofilm was determined by polymerase chain reaction. The data were statistically analyzed considering p < 0.05. Clinical conditions improved between baseline and 3 months after periodontal treatment. However, NS had a better clinical response, presenting greater PPD reduction and CAL increase in comparison to SM. Periodontal treatment reduced the levels of P. gingivalis, A. actinomycetemcomitans, and T. forsythia individually after 3 months for the NS group and after 6 months for both groups. The prevalence of Candida species was markedly higher in SM than in NS at all time points evaluated. Periodontopathogens associated or not with C. albicans or C. dubliniensis were more prevalent in SM than in NS at baseline and after 3 months. It was concluded that smoking impairs clinical and microbiological responses to periodontal therapy. Periodontopathogens combined or not with some Candida species are resistant to short-term periodontal therapy in SM.

Developing an instrument for assessing fidelity of motivational care planning: The Aboriginal and Islander Mental health initiative adherence scale.

PubMed

Prowse, Phuong-Tu; Nagel, Tricia

2014-01-01

The aim of this study was to design and trial an Adherence Scale to measure fidelity of Motivational Care Planning (MCP) within a clinical trial. This culturally adapted therapy MCP uses a client centered holistic approach that emphasises family and culture to motivate healthy life style changes. The Motivational Care Planning-Adherence Scale (MCP-AS) was developed through consultation with Aboriginal and Islander Mental Health Initiative (AIMhi) Indigenous and non-Indigenous trainers, and review of MCP training resources. The resultant ten-item scale incorporates a 9-Point Likert Scale with a supporting protocol manual and uses objective, behaviourally anchored criteria for each scale point. A fidelity assessor piloted the tool through analysis of four audio-recordings of MCP (conducted by Indigenous researchers within a study in remote communities in Northern Australia). File audits of the remote therapy sessions were utilised as an additional source of information. A Gold Standard Motivational Care Planning training video was also assessed using the MCP-AS. The Motivational Care Planning-Adherence Scale contains items measuring both process and content of therapy sessions. This scale was used successfully to assess therapy through observation of audio or video-recorded sessions and review of clinical notes. Treatment fidelity measured by the MCP-AS within the pilot study indicated high fidelity ratings. Ratings were high across the three domains of rapport, motivation, and self-management with especially high ratings for positive feedback and engagement, review of stressors and goal setting. The Motivational Care Planning-Adherence Scale has the potential to provide a measure of quality of delivery of Motivation Care Planning. The pilot findings suggest that despite challenges within the remote Indigenous community setting, Indigenous therapists delivered therapy that was of high fidelity. While developed as a research tool, the scale has the potential to support fidelity of delivery of Motivation Care Planning in clinical, supervision and training settings. Larger studies are needed to establish inter-rater reliability and internal and external validity.

The development and piloting of a leadership questionnaire for general dental practitioners: preliminary results from the North West of England and Tokyo.

PubMed

Brocklehurst, P; O'Malley, L; Hill, H; Ozaki, T; Nomura, M; Matsuda, R

2014-11-01

Key reforms in England and Japan have called for greater clinical leadership from general dental practitioners to deliver improvements in the quality of care for patients. In England, the reorganisation of the National Health Service has led to the development of Local Professional Networks to ensure services are clinically led, patient and outcome focused. In Japan, the rapidly changing demographics have led to calls for general dental practitioners to become more active in meeting the emerging population health challenges. Both require engagement at a strategic and a local level. However, little is known about what is meant by clinical leadership in dentistry or what training needs exist. The aim of this study was to develop and pilot a questionnaire to understand what general dental practitioners feel is important about clinical leadership and how they rate themselves. A 61-item questionnaire was developed from the literature, an earlier qualitative study and refined through cognitive interviews. Questionnaires were distributed to general dental practitioners across the North West of England and Tokyo, using random sequence generation. For each item, the participant had to record whether they thought the statement was an important component of clinical leadership and how they rated themselves. Both were rated using a seven-point Likert scale. Data reduction was undertaken using principal component analysis to examine for factor loadings within the questionnaire. Differences in mean scores were also used to highlight substantive differences in how general dental practitioners rated the different components of leadership and how they rated themselves. The response rate for the pilot was low (22.9% and 7.5% for North West and Tokyo respectively). The items that were considered to be important in leadership reduced to two components in the North West (accounting for 62.1% of the total variance): 'How to lead' and 'How not to lead'. In Tokyo, 56.4% of the total variance was explained by three components: 'Demonstrating personal qualities', 'Working with others' and 'How not to lead'. When the self-rated items were reduced, three factors were found to be important in the North West: 'Working with others', 'Setting direction' and 'Managing services' (55.1% of the variance). 'Working with others', 'Demonstrating personal qualities', 'Pragmatism', 'Setting direction' and 'Improving services' were found to be important in Tokyo (52.8% of the variance). The questionnaire items relating to integrity, team-working and having a positive attitude during difficult times were rated highly by both groups. Items relating to providing vision for team, being assertive and having a positive attitude had the greatest mean difference, suggesting possible areas of training need. The nature of the pilot study and the poor response rate makes any conclusion difficult to infer. Among those that participated, leadership was understood to be more important at a practice level rather than at a strategic level. The questionnaire should be refined further based on the results of the pilot and the data reduction.

Clinical Pilot Study and Computational Modeling of Bitemporal Transcranial Direct Current Stimulation, and Safety of Repeated Courses of Treatment, in Major Depression.

PubMed

Ho, Kerrie-Anne; Bai, Siwei; Martin, Donel; Alonzo, Angelo; Dokos, Socrates; Loo, Colleen K

2015-12-01

This study aimed to examine a bitemporal (BT) transcranial direct current stimulation (tDCS) electrode montage for the treatment of depression through a clinical pilot study and computational modeling. The safety of repeated courses of stimulation was also examined. Four participants with depression who had previously received multiple courses of tDCS received a 4-week course of BT tDCS. Mood and neuropsychological function were assessed. The results were compared with previous courses of tDCS given to the same participants using different electrode montages. Computational modeling examined the electric field maps produced by the different montages. Three participants showed clinical improvement with BT tDCS (mean [SD] improvement, 49.6% [33.7%]). There were no adverse neuropsychological effects. Computational modeling showed that the BT montage activates the anterior cingulate cortices and brainstem, which are deep brain regions that are important for depression. However, a fronto-extracephalic montage stimulated these areas more effectively. No adverse effects were found in participants receiving up to 6 courses of tDCS. Bitemporal tDCS was safe and led to clinically meaningful efficacy in 3 of 4 participants. However, computational modeling suggests that the BT montage may not activate key brain regions in depression more effectively than another novel montage--fronto-extracephalic tDCS. There is also preliminary evidence to support the safety of up to 6 repeated courses of tDCS.

Systemic Chemokine Levels with "Gut-Specific" Vedolizumab in Patients with Inflammatory Bowel Disease-A Pilot Study.

PubMed

Zwicker, Stephanie; Lira-Junior, Ronaldo; Höög, Charlotte; Almer, Sven; Boström, Elisabeth A

2017-08-22

Vedolizumab, a gut-specific biological treatment for inflammatory bowel disease (IBD), is an antibody that binds to the α₄β₇ integrin and blocks T-cell migration into intestinal mucosa. We aimed to investigate chemokine levels in serum of IBD-patients treated with vedolizumab. In this pilot study, we included 11 IBD patients (8 Crohn's disease, 3 ulcerative colitis) previously non-respondent to anti-tumor necrosis factor (TNF)-agents. Patients received vedolizumab at week 0, 2 and 6 and were evaluated for clinical efficacy at week 10. Clinical characteristics and routine laboratory parameters were obtained and patients were classified as responders or non-responders. Expression of 21 chemokines in serum was measured using Proximity Extension Assay and related to clinical outcome. At week 10, 6 out of 11 patients had clinically responded. Overall expression of CCL13 increased after treatment. In non-responders, expression of CCL13 and CXCL8 increased after treatment, and CCL20 and CXCL1 expressions were higher compared to responders. In responders, CCL28 decreased after treatment. C-reactive protein (CRP) correlated negatively with 6 chemokines before therapy, but not after therapy. Systemic CCL13 expression increases in IBD-patients after vedolizumab therapy and several chemokine levels differ between responders and non-responders. An increased CCL13-level when starting vedolizumab treatment, might indicate potential prognostic value of measuring chemokine levels when starting therapy with vedolizumab. This study provides new information on modulation of systemic chemokine levels after vedolizumab treatment.

Assessing the accuracy of blood RNA profiles to identify patients with post-concussion syndrome: A pilot study in a military patient population.

PubMed

Hardy, Jimmaline J; Mooney, Scott R; Pearson, Andrea N; McGuire, Dawn; Correa, Daniel J; Simon, Roger P; Meller, Robert

2017-01-01

Mild traumatic brain injury (mTBI) is a complex, neurophysiological condition that can have detrimental outcomes. Yet, to date, no objective method of diagnosis exists. Physical damage to the blood-brain-barrier and normal waste clearance via the lymphatic system may enable the detection of biomarkers of mTBI in peripheral circulation. Here we evaluate the accuracy of whole transcriptome analysis of blood to predict the clinical diagnosis of post-concussion syndrome (PCS) in a military cohort. Sixty patients with clinically diagnosed chronic concussion and controls (no history of concussion) were recruited (retrospective study design). Male patients (46) were split into a training set comprised of 20 long-term concussed (> 6 months and symptomatic) and 12 controls (no documented history of concussion). Models were validated in a testing set (control = 9, concussed = 5). RNA_Seq libraries were prepared from whole blood samples for sequencing using a SOLiD5500XL sequencer and aligned to hg19 reference genome. Patterns of differential exon expression were used for diagnostic modeling using support vector machine classification, and then validated in a second patient cohort. The accuracy of RNA profiles to predict the clinical diagnosis of post-concussion syndrome patients from controls was 86% (sensitivity 80%; specificity 89%). In addition, RNA profiles reveal duration of concussion. This pilot study shows the potential utility of whole transcriptome analysis to establish the clinical diagnosis of chronic concussion syndrome.

Visual consequences of electronic reader use: a pilot study.

PubMed

Maducdoc, Marlon M; Haider, Asghar; Nalbandian, Angèle; Youm, Julie H; Morgan, Payam V; Crow, Robert W

2017-04-01

With the increasing prevalence of electronic readers (e-readers) for vocational and professional uses, it is important to discover if there are visual consequences in the use of these products. There are no studies in the literature quantifying the incidence or severity of eyestrain, nor are there clinical characteristics that may predispose to these symptoms with e-reader use. The primary objective of this pilot study was to assess the degree of eyestrain associated with e-reader use compared to traditional paper format. The secondary outcomes of this study were to assess the rate of eyestrain associated with e-reader use and identify any clinical characteristics that may be associated with the development of eyestrain. Forty-four students were randomly assigned to study (e-reader iPAD) and control (print) groups. Participant posture, luminosity of the room, and reading distance from reading device were measured during a 1-h session for both groups. At the end of the session, questionnaires were administered to determine symptoms. Significantly higher rates of eyestrain (p = 0.008) and irritation (p = 0.011) were found among the iPAD study group as compared to the print 'control' group. The study group was also 4.9 times more likely to report severe eyestrain (95 % CI [1.4, 16.9]). No clinical characteristics predisposing to eyestrain could be identified. These findings conclude that reading on e-readers may induce increased levels of irritation and eyestrain. Predisposing factors, etiology, and potential remedial interventions remain to be determined.

Adding Paracetamol to Ibuprofen for the Treatment of Patent Ductus Arteriosus in Preterm Infants: A Double-Blind, Randomized, Placebo-Controlled Pilot Study.

PubMed

Hochwald, Ori; Mainzer, Gur; Borenstein-Levin, Liron; Jubran, Huda; Dinur, Gil; Zucker, Meirav; Mor, Malka; Khoury, Asaad; Kugelman, Amir

2018-05-21

 The objective of this study was to compare the closure rate of hemodynamically significant patent ductus arteriosus (hsPDA) of intravenous ibuprofen + paracetamol (acetaminophen) versus ibuprofen + placebo, in preterm infants of 24 to 31 6/7 weeks postmenstrual age.  This is a single-center, double-blind, randomized controlled pilot study. Infants were assigned for treatment with either intravenous ibuprofen + paracetamol ( n  = 12) or ibuprofen + placebo ( n  = 12).  There was no statistical difference in baseline characteristics of the two groups. Echocardiography parameters were comparable before treatment in both groups. There was a trend toward higher hsPDA closure rate in the paracetamol group in comparison to the placebo group (83 vs. 42%, p  = 0.08). No adverse effects, clinical or laboratory, were associated with adding paracetamol.  Our pilot study was unable to detect a beneficial effect by adding intravenous paracetamol to ibuprofen for the treatment of hsPDA. Larger prospective studies are needed to explore the positive tendency suggested by our results and to assure safety. Thieme Medical Publishers 333 Seventh Avenue, New York, NY 10001, USA.

AMS in drug development at GSK

NASA Astrophysics Data System (ADS)

Young, G. C.; Ellis, W. J.

2007-06-01

A history of the use of AMS in GSK studies spanning the last 8 years (1998-2005) is presented, including use in pilot studies through to clinical, animal and in vitro studies. A brief summary of the status of GSK's in-house AMS capability is outlined and views on the future of AMS in GSK are presented, including potential impact on drug development and potential advances in AMS technology.

Group supervision for healthcare professionals within primary care for patients with psychosomatic health problems: a pilot intervention study.

PubMed

Bullington, Jennifer; Cronqvist, Agneta

2018-03-01

In primary health care, efficacious treatment strategies are lacking for these patients, although the most prominent symptoms accounting for consultation in primary care often cannot be related to any biological causes. The aim was to explore whether group supervision from a specific phenomenological theory of psychosomatics could provide healthcare professionals treating patients with psychosomatic health issues within primary care a deeper understanding of these conditions and stimulate profession-specific treatment strategies. Our research questions were as follows: (i) What is the healthcare professionals' understanding of psychosomatics before and after the intervention? (ii) What are the treatment strategies for this group of patients before and after the intervention? The study was an explorative qualitative intervention pilot study. The six participants from a primary healthcare setting in a medium-sized city in Sweden participated in the study. A supervision group was formed, based on a mix of professions, age, gender and years of clinical experience. Supervision consisted of one 75-minutes meeting every month during the course of 6 months. Participants were interviewed before and after the supervision intervention. The study showed two distinct categories emerged from the data. One category of healthcare professionals espoused a psycho-educative approach, while the other lacked a cohesive approach. The supervision improved the second category of healthcare professionals' understanding of psychosomatics. The psycho-educative group did not change their understanding of psychosomatics, although they felt strengthened in their approach by the supervision. Profession-specific strategies were not developed. This pilot study indicates that a relatively short supervision intervention can aid clinicians in their clinical encounters with these patients; however, further research is necessary to ascertain the value of the specific phenomenologically based supervision intervention. © 2017 Nordic College of Caring Science.

EEG Neurofeedback for ADHD: Double-Blind Sham-Controlled Randomized Pilot Feasibility Trial

ERIC Educational Resources Information Center

Arnold, L. Eugene; Lofthouse, Nicholas; Hersch, Sarah; Pan, Xueliang; Hurt, Elizabeth; Bates, Bethany; Kassouf, Kathleen; Moone, Stacey; Grantier, Cara

2013-01-01

Objective: Preparing for a definitive randomized clinical trial (RCT) of neurofeedback (NF) for ADHD, this pilot trial explored feasibility of a double-blind, sham-controlled design and adherence/palatability/relative effect of two versus three treatments/week. Method: Unmedicated 6- to 12-year-olds with "Diagnostic and Statistical Manual of…

Italian multicentre study on microbial environmental contamination in dental clinics: a pilot study.

PubMed

Pasquarella, Cesira; Veronesi, Licia; Castiglia, Paolo; Liguori, Giorgio; Montagna, Maria Teresa; Napoli, Christian; Rizzetto, Rolando; Torre, Ida; Masia, Maria Dolores; Di Onofrio, Valeria; Colucci, Maria Eugenia; Tinteri, Carola; Tanzi, Marialuisa

2010-09-01

The dental practice is associated with a high risk of infections, both for patients and healthcare operators, and the environment may play an important role in the transmission of infectious diseases. A microbiological environmental investigation was carried out in six dental clinics as a pilot study for a larger multicentre study that will be performed by the Italian SItI (Society of Hygiene, Preventive Medicine and Public Health) working group "Hygiene in Dentistry". Microbial contamination of water, air and surfaces was assessed in each clinic during the five working days of the week, before and during treatments. Air and surfaces were also examined at the end of the daily activity. A wide variation was found in microbial environmental contamination, both within the participating clinics and relative to the different sampling times. Microbial water contamination in Dental Unit Water Systems (DUWS) reached values of up to 26x10(4)cfu/mL (colony forming units per millilitre). P. aeruginosa was found in 33% of the sampled DUWS and Legionella spp. in 50%. A significant decrease in the Total Viable Count (TVC) was recorded during the activity. Microbial air contamination showed the highest levels during dental treatments and tended to decrease at the end of the working activity (p<0.05). Microbial buildup on surfaces increased significantly during the working hours. As these findings point out, research on microbial environmental contamination and the related risk factors in dental clinics should be expanded and should also be based on larger collections of data, in order to provide the essential knowledge aimed at targeted preventive interventions. Copyright 2010 Elsevier B.V. All rights reserved.

System requirements for a computerised patient record information system at a busy primary health care clinic.

PubMed

Blignaut, P J; McDonald, T; Tolmie, C J

2001-05-01

A prototyping approach was used to determine the essential system requirements of a computerised patient record information system for a typical township primary health care clinic. A pilot clinic was identified and the existing manual system and business processes in this clinic was studied intensively before the first prototype was implemented. Interviews with users, incidental observations and analysis of actual data entered were used as primary techniques to refine the prototype system iteratively until a system with an acceptable data set and adequate functionalities were in place. Several non-functional and user-related requirements were also discovered during the prototyping period.

RapidSplint: virtual splint generation for orthognathic surgery - results of a pilot series.

PubMed

Adolphs, Nicolai; Liu, Weichen; Keeve, Erwin; Hoffmeister, Bodo

2014-01-01

Within the domain of craniomaxillofacial surgery, orthognathic surgery is a special field dedicated to the correction of dentofacial anomalies resulting from skeletal malocclusion. Generally, in such cases, an interdisciplinary orthodontic and surgical treatment approach is required. After initial orthodontic alignment of the dental arches, skeletal discrepancies of the jaws can be corrected by distinct surgical strategies and procedures in order to achieve correct occlusal relations, as well as facial balance and harmony within individualized treatment concepts. To transfer the preoperative surgical planning and reposition the mobilized dental arches with optimal occlusal relations, surgical splints are typically used. For this purpose, different strategies have been described which use one or more splints. Traditionally, these splints are manufactured by a dental technician based on patient-specific dental casts; however, computer-assisted technologies have gained increasing importance with respect to preoperative planning and its subsequent surgical transfer. In a pilot study of 10 patients undergoing orthognathic corrections by a one-splint strategy, two final occlusal splints were produced for each patient and compared with respect to their clinical usability. One splint was manufactured in the traditional way by a dental technician according to the preoperative surgical planning. After performing a CBCT scan of the patient's dental casts, a second splint was designed virtually by an engineer and surgeon working together, according to the desired final occlusion. For this purpose, RapidSplint, a custom-made software platform, was used. After post-processing and conversion of the datasets into .stl files, the splints were fabricated by the PolyJet procedure using photo polymerization. During surgery, both splints were inserted after mobilization of the dental arches then compared with respect to their clinical usability according to the occlusal fitting. Using the workflow described above, virtual splints could be designed and manufactured for all patients in this pilot study. Eight of 10 virtual splints could be used clinically to achieve and maintain final occlusion after orthognathic surgery. In two cases virtual splints were not usable due to insufficient occlusal fitting, and even two of the traditional splints were not clinically usable. In five patients where both types of splints were available, their occlusal fitting was assessed as being equivalent, and in one case the virtual splint showed even better occlusal fitting than the traditional splint. In one case where no traditional splint was available, the virtual splint proved to be helpful in achieving the final occlusion. In this pilot study it was demonstrated that clinically usable splints for orthognathic surgery can be produced by computer-assisted technology. Virtual splint design was realized by RapidSplint®, an in-house software platform which might contribute in future to shorten preoperative workflows for the production of orthognathic surgical splints.

Assessing the Feasibility of a Social Media to Promote Weight Management Engagement in Adolescents with Severe Obesity: Pilot Study.

PubMed

Prout Parks, Elizabeth; Moore, Reneé H; Li, Ziyi; Bishop-Gilyard, Chanelle T; Garrett, Andrew R; Hill, Douglas L; Bruton, Yasmeen P; Sarwer, David B

2018-03-19

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. 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. 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. 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). 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. ©Elizabeth Prout Parks, Renee' H Moore, Ziyi Li, Chanelle T Bishop-Gilyard, Andrew R Garrett, Douglas L Hill, Yasmeen P. Bruton, David B Sarwer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 19.03.2018.

Chronic care coordination by integrating care through a team-based, population-driven approach: a case study.

PubMed

van Eeghen, Constance O; Littenberg, Benjamin; Kessler, Rodger

2018-05-23

Patients with chronic conditions frequently experience behavioral comorbidities to which primary care cannot easily respond. This study observed a Vermont family medicine practice with integrated medical and behavioral health services that use a structured approach to implement a chronic care management system with Lean. The practice chose to pilot a population-based approach to improve outcomes for patients with poorly controlled Type 2 diabetes using a stepped-care model with an interprofessional team including a community health nurse. This case study observed the team's use of Lean, with which it designed and piloted a clinical algorithm composed of patient self-assessment, endorsement of behavioral goals, shared documentation of goals and plans, and follow-up. The team redesigned workflows and measured reach (patients who engaged to the end of the pilot), outcomes (HbA1c results), and process (days between HbA1c tests). The researchers evaluated practice member self-reports about the use of Lean and facilitators and barriers to move from pilot to larger scale applications. Of 20 eligible patients recruited over 3 months, 10 agreed to participate and 9 engaged fully (45%); 106 patients were controls. Relative to controls, outcomes and process measures improved but lacked significance. Practice members identified barriers that prevented implementation of all changes needed but were in agreement that the pilot produced useful outcomes. A systematized, population-based, chronic care management service is feasible in a busy primary care practice. To test at scale, practice leadership will need to allocate staffing, invest in shared documentation, and standardize workflows to streamline office practice responsibilities.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. © 2017 Royal College of Speech and Language Therapists.

A toolkit for incorporating genetics into mainstream medical services: Learning from service development pilots in England

PubMed Central

2010-01-01

Background As advances in genetics are becoming increasingly relevant to mainstream healthcare, a major challenge is to ensure that these are integrated appropriately into mainstream medical services. In 2003, the Department of Health for England announced the availability of start-up funding for ten 'Mainstreaming Genetics' pilot services to develop models to achieve this. Methods Multiple methods were used to explore the pilots' experiences of incorporating genetics which might inform the development of new services in the future. A workshop with project staff, an email questionnaire, interviews and a thematic analysis of pilot final reports were carried out. Results Seven themes relating to the integration of genetics into mainstream medical services were identified: planning services to incorporate genetics; the involvement of genetics departments; the establishment of roles incorporating genetic activities; identifying and involving stakeholders; the challenges of working across specialty boundaries; working with multiple healthcare organisations; and the importance of cultural awareness of genetic conditions. Pilots found that the planning phase often included the need to raise awareness of genetic conditions and services and that early consideration of organisational issues such as clinic location was essential. The formal involvement of genetics departments was crucial to success; benefits included provision of clinical and educational support for staff in new roles. Recruitment and retention for new roles outside usual career pathways sometimes proved difficult. Differences in specialties' working practices and working with multiple healthcare organisations also brought challenges such as the 'genetic approach' of working with families, incompatible record systems and different approaches to health professionals' autonomous practice. 'Practice points' have been collated into a Toolkit which includes resources from the pilots, including job descriptions and clinical tools. These can be customised for reuse by other services. Conclusions Healthcare services need to translate advances in genetics into benefits for patients. Consideration of the issues presented here when incorporating genetics into mainstream medical services will help ensure that new service developments build on the body of experience gained by the pilots, to provide high quality services for patients with or at risk of genetic conditions. PMID:20470377

A toolkit for incorporating genetics into mainstream medical services: Learning from service development pilots in England.

PubMed

Bennett, Catherine L; Burke, Sarah E; Burton, Hilary; Farndon, Peter A

2010-05-14

As advances in genetics are becoming increasingly relevant to mainstream healthcare, a major challenge is to ensure that these are integrated appropriately into mainstream medical services. In 2003, the Department of Health for England announced the availability of start-up funding for ten 'Mainstreaming Genetics' pilot services to develop models to achieve this. Multiple methods were used to explore the pilots' experiences of incorporating genetics which might inform the development of new services in the future. A workshop with project staff, an email questionnaire, interviews and a thematic analysis of pilot final reports were carried out. Seven themes relating to the integration of genetics into mainstream medical services were identified: planning services to incorporate genetics; the involvement of genetics departments; the establishment of roles incorporating genetic activities; identifying and involving stakeholders; the challenges of working across specialty boundaries; working with multiple healthcare organisations; and the importance of cultural awareness of genetic conditions. Pilots found that the planning phase often included the need to raise awareness of genetic conditions and services and that early consideration of organisational issues such as clinic location was essential. The formal involvement of genetics departments was crucial to success; benefits included provision of clinical and educational support for staff in new roles. Recruitment and retention for new roles outside usual career pathways sometimes proved difficult. Differences in specialties' working practices and working with multiple healthcare organisations also brought challenges such as the 'genetic approach' of working with families, incompatible record systems and different approaches to health professionals' autonomous practice. 'Practice points' have been collated into a Toolkit which includes resources from the pilots, including job descriptions and clinical tools. These can be customised for reuse by other services. Healthcare services need to translate advances in genetics into benefits for patients. Consideration of the issues presented here when incorporating genetics into mainstream medical services will help ensure that new service developments build on the body of experience gained by the pilots, to provide high quality services for patients with or at risk of genetic conditions.

An Unembalmed Cadaveric Preparation for Simulating Pleural Effusion: A Pilot Study of Chest Percussion Involving Medical Students

ERIC Educational Resources Information Center

Cook, Mark S.; Kernahan, Peter J.

2017-01-01

Cadaveric simulations are an effective way to add clinical context to an anatomy course. In this study, unembalmed (fresh) cadavers were uniquely prepared to simulate pleural effusion to teach chest percussion and review thoracic anatomy. Thirty first-year medical students were assigned to either an intervention (Group A) or control group (Group…

Correlation of serum MMP3 and other biomarkers with clinical outcomes in patients with ankylosing spondylitis: A pilot study

USDA-ARS?s Scientific Manuscript database

The studies aimed to assess a set of biomarkers for their correlations with disease activity/severity of patients with ankylosing spondylitis (AS). A total of 24 AS patients were treated with etanercept and prospectively followed for 12 weeks. Serum levels of TNF-alpha, IFN-gamma, TGF-beta, IL6, IL1...

Programmed Physical Exertion in Recovery From Sports-Related Concussion: A Randomized Pilot Study.

PubMed

Maerlender, Arthur; Rieman, Wanda; Lichtenstein, Jonathan; Condiracci, C

2015-01-01

Although no data exist, general practice recommends only rest following concussion. This randomized clinical trial found that programmed physical exertion during recovery produced no significant differences in recovery time between groups of participants. However, high levels of exertion were deleterious. This study provides initial evidence that moderate physical activity is a safe replacement behavior during recovery.

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…

Clinician–Investigator Training and the Need to Pilot New Approaches to Recruiting and Retaining This Workforce

PubMed Central

Hall, Alison K.; Lund, P. Kay

2017-01-01

Clinician–investigators, also called physician–scientists, offer critical knowledge and perspectives that benefit research on basic science mechanisms, improved diagnostic and therapeutic approaches, population and outcomes medicine, health policy, and health services, yet few clinically trained health professionals pursue a research career. Sustaining this workforce requires attention to the unique challenges faced by investigators who must achieve clinical and research competence during training and their careers. These challenges include the duration of required clinical training, limited or discontinuous research opportunities, high levels of educational debt, balancing the dual obligations and rewards of clinical care and research, competition for research funding, and the need for leadership development after training. Women and individuals from underrepresented racial and ethnic groups comprise a small percentage of this workforce. The authors summarize the recent literature on training for clinician–investigators, emphasizing approaches with encouraging outcomes that warrant broader implementation. Using this overview as background, they convened three workshops at the National Institutes of Health in 2016 to identify and refine key priorities for potential new pilot programs to recruit and retain the clinician–investigator workforce. From these workshops emerged three priorities for future pilot programs: (1) support for research in residency, (2) new research on-ramps for health professionals at multiple career stages, and (3) national networks to diversify and sustain clinician–investigator faculty. Implementation of any pilot program will require coordinated commitment from academic health centers, medical licensing/certification boards, professional societies, and clinician–investigators themselves, in addition to support from the National Institutes of Health. PMID:28767499

Clinician-Investigator Training and the Need to Pilot New Approaches to Recruiting and Retaining This Workforce.

PubMed

Hall, Alison K; Mills, Sherry L; Lund, P Kay

2017-10-01

Clinician-investigators, also called physician-scientists, offer critical knowledge and perspectives that benefit research on basic science mechanisms, improved diagnostic and therapeutic approaches, population and outcomes medicine, health policy, and health services, yet few clinically trained health professionals pursue a research career. Sustaining this workforce requires attention to the unique challenges faced by investigators who must achieve clinical and research competence during training and their careers. These challenges include the duration of required clinical training, limited or discontinuous research opportunities, high levels of educational debt, balancing the dual obligations and rewards of clinical care and research, competition for research funding, and the need for leadership development after training. Women and individuals from underrepresented racial and ethnic groups comprise a small percentage of this workforce.The authors summarize the recent literature on training for clinician-investigators, emphasizing approaches with encouraging outcomes that warrant broader implementation. Using this overview as background, they convened three workshops at the National Institutes of Health in 2016 to identify and refine key priorities for potential new pilot programs to recruit and retain the clinician-investigator workforce. From these workshops emerged three priorities for future pilot programs: (1) support for research in residency, (2) new research on-ramps for health professionals at multiple career stages, and (3) national networks to diversify and sustain clinician-investigator faculty. Implementation of any pilot program will require coordinated commitment from academic health centers, medical licensing/certification boards, professional societies, and clinician-investigators themselves, in addition to support from the National Institutes of Health.