Training Decay Selection for Usability Validation: Pilot Study Methodology and Results for an FDA Research Grant

2020 ◽  
Vol 64 (1) ◽  
pp. 721-725
Author(s):  
Kelli Sum ◽  
Lana Sneath ◽  
Shannon Clark ◽  
Dan Nathan-Roberts
Keyword(s):  
Pilot Study ◽  
Medical Devices ◽  
Insulin Pump ◽  
Small Sample Size ◽  
Small Sample ◽  
Study Methodology ◽  
Selection For ◽  
Size Task ◽  
Task Types ◽  
Research Grant

As medical devices become more technologically advanced, patients risk forgetting their training and missing critical steps. Existing literature explores ways to train patients on medical devices but does not quantify how long information is retained, which is essential for valid medical device testing before approval. The aim of the research presented is to validate a robust method of quantifying training decay research across multiple periods. Some participants were trained on an insulin pump and assigned to decay periods of one hour, one day, or one week. Additionally, an untrained cohort represented a theoretical maximum decay. Although results are not statistically significant due to a small sample size, task performance shows possible differences between time points and task types. Improvements and considerations translating this pilot study into a more extensive main study are also discussed.

scholarly journals The Symbiotic Mutualism between Co-Creation and Entrepreneurship

2021 ◽  
Vol 13 (11) ◽  
pp. 6285
Author(s):  
Sandra Misiak-Kwit ◽  
Małgorzata Wiścicka-Fernando ◽  
Kelaniyage Shihan Dilruk Fernando
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Strong Association ◽  
Sampling Technique ◽  
Small Sample ◽  
Entrepreneurial Intentions ◽  
Added Value ◽  
Primary Data ◽  
Exploratory Research ◽  
Symbiotic Mutualism

In this manuscript, the authors aim to explore firstly the association between entrepreneurial mindset and co-creation experience, secondly the association between co-creation experience and entrepreneurial intentions, and thirdly the association between entrepreneurial mindset and entrepreneurial intentions within the sustainability context. In this paper, the authors present the results of the pilot study. Primary data were collected from 500 university students from China, Georgia, Poland, Romania, and Sri Lanka by using a convenient sampling technique, and a literature review was the primary method of the concept development. The authors selected the above-mentioned countries to collect primary data by using a convenient sampling technique based on accessibility; they also visited all analysed countries in order to conduct the pilot survey personally. Descriptive statistics and the Spearman’s rank correlation coefficient were applied as primary statistical methods. The findings reveal that there is a very strong association between co-creation experience and entrepreneurial intentions, a very weak negative association between entrepreneurial mindset and co-creation experience, and, surprisingly, a weak association between entrepreneurial mindset and entrepreneurial intentions. The added value of the conducted pilot research involves filling in a gap regarding the relationship between experience and the subjective norm. In the presented pilot research, co-creation experience was compared with not only entrepreneurial mindset but with entrepreneurial intentions as well. An additional value of this exploratory research is compiling an international comparison. The main contribution of this pilot study is examining the symbiotic mutualism between co-creation and entrepreneurship. Among many platforms of associations, the following can be differentiated: creativity, innovativeness, openness, engagement, awareness, motivation, trust (level of social capital), and recognizing the significance of social and sustainable development objectives. Due to the small sample size, the results cannot be generalised. Results refer only to the respondents. However, the findings of the pilot study are the basis for further research studies on symbiotic mutualism between entrepreneurship and co-creation.

scholarly journals Blinding in electric current stimulation in subacute neglect patients with current densities of 0.8 A/m2: a cross-over pilot study

2021 ◽  
Vol 14 (1) ◽  
Author(s):  
Anna Gorsler ◽  
Ulrike Grittner ◽  
Nadine Külzow ◽  
Torsten Rackoll
Keyword(s):  
Pilot Study ◽  
Electric Fields ◽  
Standard Care ◽  
Small Sample Size ◽  
Small Sample ◽  
Related Factors ◽  
Attentional Deficits ◽  
Age Related ◽  
Current Densities ◽  
Improve Standard

Abstract Objective Neglect after stroke is a disabling disorder and its rehabilitation is a major challenge. Transcranial direct current stimulation (tDCS) seems to be a promising adjuvant technique to improve standard care neglect therapy. Since electric fields are influenced by age-related factors, higher current densities are probably needed for effective treatment in aged stroke patients. Validation of treatment efficacy requires sham-controlled experiments, but increased current densities might comprise blinding. Therefore, a pilot study was conducted to test sham adequacy when using current density of 0.8 A/m2. Whether especially neglect patients who mainly suffer from perceptual and attentional deficits are able to differentiate beyond chance active from sham tDCS was investigated in a randomized cross-over design (active/sham stimulation) in 12 early subacute patients with left-sided hemineglect. Stimulation (0.8 A/m2) was performed simultaneous to standard care neglect therapy. Results Odds ratio of correct guessing an atDCS condition compared to wrongly judge an atDCS condition as sham was 10.00 (95%CI 0.65–154.40, p = 0.099). However, given the small sample size and high OR, although likely somewhat overestimated, results require careful interpretation and blinding success in neglect studies with current densities of 0.8 A/m2 should be further confirmed.

Perceptions and Understanding of Diabetes Mellitus Technology in Adults with Type 1 or Type 2 DM: A Pilot Survey from Pakistan

2021 ◽  
pp. 193229682110111
Author(s):  
Sarah Nadeem ◽  
Uswah Siddiqi ◽  
Russell Seth Martins ◽  
Kaleemullah Badini
Keyword(s):  
Diabetes Mellitus ◽  
Pilot Study ◽  
Diabetes Care ◽  
Online Survey ◽  
Small Sample Size ◽  
Developed Countries ◽  
Small Sample ◽  
Cost Of Care ◽  
Cross Sectional ◽  
Specific Patient

Introduction: Diabetes mellitus technology (DMT) is increasingly used for routine management in developed countries, yet its uptake in developing countries is not as consistent. Multiple factors may influence this, including country specific patient perception regarding DMT. We conducted a pilot study in Pakistan to understand this important question which has not been studied yet. Methods: A cross-sectional pilot study was conducted in Pakistan. An anonymous survey exploring perceptions of diabetes technology was circulated on social media platforms, collecting responses over 2 weeks. Target population included adults (≥18 years) living in Pakistan, with DM1 or 2. Results: A total of 40 responses were received. The majority (36/40) reported using conventional glucometers. Nine used continuous glucose monitoring (CGM). Thirty-two of 40 patients believed DMT improved diabetes care, 22 felt it helped decreased risk of Diabetes-related complications. 15/40 stated that DMT results in increased cost of care. Sixteen reported their diabetes care teams had never discussed wearable DMT options whereas 11 disliked them because they did not want a device on their self. Conclusion: In our pilot study we have identified broad themes of opportunity and challenges to DMT use in Pakistan. Patients’ perceptions regarding DMT were generally positive but significant barriers to its acceptance included high cost, lack of discussion between doctor and patient about available technology and personal hesitation. Limitations of our study include sampling bias (online survey) and small sample size, but this data can help inform larger studies, to look at this important topic in greater detail.

scholarly journals Innovation in Pediatric Medical Devices: Proceedings From The West Coast Consortium for Technology & Innovation in Pediatrics 2019 Annual Stakeholder Summit

10.2196/17467 ◽  
2020 ◽  
Vol 5 (1) ◽  
pp. e17467
Author(s):  
Juan Espinoza ◽  
Kathryne Cooper ◽  
Nadine Afari ◽  
Payal Shah ◽  
Sriharinarayana Batchu ◽  
...  
Keyword(s):  
Los Angeles ◽  
Medical Device ◽  
Medical Devices ◽  
West Coast ◽  
Small Sample Size ◽  
Small Sample ◽  
The West ◽  
Device Development ◽  
Small Market ◽  
Broad Array

Pediatric medical devices cover a broad array of indications and risk profiles, and have helped to reduce disease burden and improve quality of life for numerous children. However, many of the devices used in pediatrics are not intended for or tested on children. Several barriers have been identified that pose difficulties in bringing pediatric medical devices to the market. These include a small market and small sample size; unique design considerations; regulatory complexities; lack of infrastructure for research, development, and evaluation; and low return on investment. In 2007, the Food and Drug Administration (FDA) created the Pediatric Device Consortia (PDC) Grants Program under the administration of the Office of Orphan Products Development. In 2018, the FDA awarded over US $30 million to five new PDCs. The West Coast Consortium for Technology & Innovation in Pediatrics (CTIP) is one of these PDCs and is centered at the Children’s Hospital Los Angeles. In February 2019, CTIP convened its primary stakeholders to discuss its priorities and activities for the new grant cycle. In this paper, we have presented a report of the summit proceedings to raise awareness and advocate for patients and pediatric medical device innovators as well as to inform the activities and priorities of other organizations and agencies engaged in pediatric medical device development.

Do you see what I see? A randomised pilot study to evaluate the effectiveness and efficiency of simulation-based training with videolaryngoscopy for neonatal intubation

2015 ◽  
Vol 1 (1) ◽  
pp. 12-18 ◽  
Author(s):  
Lindsay C Johnston ◽  
Ruijun Chen ◽  
Travis M Whitfill ◽  
Christie J Bruno ◽  
Orly L Levit ◽  
...  
Keyword(s):  
Pilot Study ◽  
Small Sample Size ◽  
Deliberate Practice ◽  
Neonatal Resuscitation ◽  
Technical Skills ◽  
Small Sample ◽  
Efficiency And Effectiveness ◽  
Global Skills ◽  
Visual Confirmation ◽  
Future Work

IntroductionDirect laryngoscopy (DL) and airway intubation are critical for neonatal resuscitation. A challenge in teaching DL is that the instructor cannot assess the learners’ airway view. Videolaryngoscopy (VL), which allows display of a patient's airway on a monitor, enables the instructor to view the airway during the procedure. This pilot study compared deliberate practice using either VL with instruction (I-VL) or traditional DL. We hypothesised that I-VL would improve the efficiency and effectiveness of neonatal intubation (NI) training.MethodsParticipants (students, paediatric interns and neonatal fellows) were randomised to I-VL or DL. Baseline technical skills were assessed using a skills checklist and global skills assessment. Following educational sessions, deliberate practice was performed on mannequins using the Storz C-MAC. With I-VL, the instructor could guide training using a real-time airway monitor view. With DL, feedback was based solely on technique or direct visual confirmation, but the instructor and learner views were not concurrent. During summative assessment, procedural skills checklists were used to evaluate intubation ability on a neonatal airway trainer. The duration of attempts was recorded, and recorded airway views were blindly reviewed for airway grade. ‘Effectiveness’ reflected achievement of the minimum passing score (MPS). ‘Efficiency’ was the duration of training for learners achieving the MPS.Results58 learners were randomised. Baseline demographics were similar. All participants had a significant improvement in knowledge, skills and comfort/confidence following training. There were no significant differences between randomised groups in efficiency or effectiveness, but trends towards improvement in each were noted. Fellows were more likely to achieve ‘competency’ postinstruction compared to non-fellows (p<0.001).ConclusionsThis educational intervention to teach NI increased the learner's knowledge, technical skills and confidence in procedural performance in both groups. I-VL did not improve training effectiveness. The small sample size and participant diversity may have limited findings, and future work is indicated.

Effects of the leucovorin shortage: Pilot study investigating cost, efficacy, and toxicity comparison of low fixed-dose versus body surface area-adjusted leucovorin dosing in patients with resectable colon or metastatic colorectal cancer

2016 ◽  
Vol 23 (3) ◽  
pp. 163-172 ◽  
Author(s):  
Brandon R Shank ◽  
Amy H Seung ◽  
Katharine Kinsman ◽  
Matthew J Newman ◽  
Ross C Donehower ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Adverse Event ◽  
Pilot Study ◽  
Metastatic Colorectal Cancer ◽  
Small Sample Size ◽  
Small Sample ◽  
Disease Stage ◽  
Fixed Dose ◽  
Dosing Strategies ◽  
Event Rates

Purpose As a result of the leucovorin shortage, we switched from BSA-adjusted to low fixed-dose leucovorin in patients with colon cancer receiving fluorouracil-containing therapy. Methods A retrospective, pilot study of adults receiving intravenous leucovorin as part of a fluorouracil-containing treatment was conducted including individuals with stage II or III colon or newly diagnosed metastatic colorectal cancer. One low fixed-dose (leucovorin 50 mg) patient was matched by the investigator to one BSA-adjusted (leucovorin 200–500 mg/m2/dose) patient on disease stage and age. The objectives were to compare cost of alternative dosing strategies as well as efficacy and adverse event rates. Only patients being treated in the first-line metastatic colorectal cancer setting were included in the efficacy analysis. Results Fifty-eight patients were included. Leucovorin cost was reduced by 7- to 14-fold, and we were able to conserve a total of 1580–3400 doses of leucovorin by changing to fixed-dose (estimated from 200 mg/m2 or 400 mg/m2 dosing strategies, respectively). No statistically significant differences in progression-free survival ( p = 0.254), overall survival ( p = 0.923), or complications resulted. Conclusion Our decision to reduce the dose of leucovorin allowed us to conserve supply and control cost. The small sample size did not allow us to detect differences in efficacy or adverse event rates, and thus a larger study would be required to confirm our findings that efficacy was not compromised nor adverse effects greater.

scholarly journals The Tree Is My Anchor: A Pilot Study on the Treatment of BED through Nature-Based Therapy

2018 ◽  
Vol 15 (11) ◽  
pp. 2486 ◽  
Author(s):  
Sus Corazon ◽  
Ulrik Sidenius ◽  
Katrine Vammen ◽  
Sabine Klinker ◽  
Ulrika Stigsdotter ◽  
...  
Keyword(s):  
Eating Disorder ◽  
Pilot Study ◽  
Binge Eating ◽  
Subjective Experience ◽  
Small Sample Size ◽  
Well Being ◽  
Self Esteem ◽  
Small Sample ◽  
Structured Interviews ◽  
Eating Disorder Examination

Binge eating disorder (BED), characterized by recurrent episodes of binge eating with a subjective experience of lack of control, is the world’s most common eating disorder. The aim of the present pilot study was to examine the feasibility of implementing nature-based therapy (NBT) in the treatment of BED. The NBT intervention was compared to Support Group Meetings (SGMs), which are the only publicly available form of support for people diagnosed with BED in Denmark. Twenty participants with a BED diagnosis were included in the study, which had a mixed-methods design including Eating Disorder Examination interviews, semi-structured interviews, and questionnaires measuring well-being (The Psychological General Well-Being Index) and self-esteem (Rosenberg’s Self-Esteem Scale). Both the NBT and the SGMs showed positive results on all outcome measures (decreases in binge eating episodes and increases in general psychological well-being and self-esteem). The interviews indicated that the NBT context made the psychotherapeutic content more accessible to the participants and further helped them transfer the therapeutic gains to daily life after completing treatment. However, these results should be interpreted with caution due to the small sample size—ideally, they would need to be tested on a larger, randomized sample.

scholarly journals Epigenetics and Proteomics Join Transcriptomics in the Quest for Tuberculosis Biomarkers

mBio ◽  
2015 ◽  
Vol 6 (5) ◽  
Author(s):  
Maria M. Esterhuyse ◽  
January Weiner ◽  
Etienne Caron ◽  
Andre G. Loxton ◽  
Marco Iannaccone ◽  
...  
Keyword(s):  
Dna Methylation ◽  
Pilot Study ◽  
Large Scale ◽  
Small Sample Size ◽  
Protein Translation ◽  
Small Sample ◽  
Transcriptional Level ◽  
Content Type ◽  
Dna Methylome ◽  
Large Scale Study

ABSTRACT An estimated one-third of the world's population is currently latently infected with Mycobacterium tuberculosis. Latent M. tuberculosis infection (LTBI) progresses into active tuberculosis (TB) disease in ~5 to 10% of infected individuals. Diagnostic and prognostic biomarkers to monitor disease progression are urgently needed to ensure better care for TB patients and to decrease the spread of TB. Biomarker development is primarily based on transcriptomics. Our understanding of biology combined with evolving technical advances in high-throughput techniques led us to investigate the possibility of additional platforms (epigenetics and proteomics) in the quest to (i) understand the biology of the TB host response and (ii) search for multiplatform biosignatures in TB. We engaged in a pilot study to interrogate the DNA methylome, transcriptome, and proteome in selected monocytes and granulocytes from TB patients and healthy LTBI participants. Our study provides first insights into the levels and sources of diversity in the epigenome and proteome among TB patients and LTBI controls, despite limitations due to small sample size. Functionally the differences between the infection phenotypes (LTBI versus active TB) observed in the different platforms were congruent, thereby suggesting regulation of function not only at the transcriptional level but also by DNA methylation and microRNA. Thus, our data argue for the development of a large-scale study of the DNA methylome, with particular attention to study design in accounting for variation based on gender, age, and cell type. IMPORTANCE DNA methylation modifies the transcriptional program of cells. We have focused on two major populations of leukocytes involved in immune response to infectious diseases, granulocytes and monocytes, both of which are professional phagocytes that engulf and kill bacteria. We have interrogated how DNA methylation, gene expression, and protein translation differ in these two cell populations between healthy individuals and patients suffering from TB. To better understand the underlying biologic mechanisms, we harnessed a statistical enrichment analysis, taking advantage of predefined and well-characterized gene sets. Not only were there clear differences on various levels between the two populations, but there were also differences between TB patients and healthy controls in the transcriptome, proteome, and, for the first time, DNA methylome in these cells. Our pilot study emphasizes the value of a large-scale study of the DNA methylome taking into account our findings.

Wrapper feature selection for small sample size data driven by complete error estimates

2012 ◽  
Vol 108 (1) ◽  
pp. 138-150 ◽  
Author(s):  
Martin Macaš ◽  
Lenka Lhotská ◽  
Eduard Bakstein ◽  
Daniel Novák ◽  
Jiří Wild ◽  
...  
Keyword(s):  
Feature Selection ◽  
Sample Size ◽  
Error Estimates ◽  
Small Sample Size ◽  
Small Sample ◽  
Data Driven ◽  
Selection For ◽  
Wrapper Feature Selection ◽  
Size Data

scholarly journals Ultra-Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI) Pilot Study Results

2020 ◽  
Vol 11 ◽  
Author(s):  
Liat Haruvi Catalan ◽  
Mira Levis Frenk ◽  
Ella Adini Spigelman ◽  
Yair Engelberg ◽  
Shira Barzilay ◽  
...  
Keyword(s):  
Pilot Study ◽  
Suicidal Ideation ◽  
Children And Adolescents ◽  
Crisis Intervention ◽  
Mental Health Treatment ◽  
Small Sample Size ◽  
Age Groups ◽  
Small Sample ◽  
Preliminary Results ◽  
Study Results

In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is also prominent in Israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate. To address the critical need in crisis intervention for children and adolescents at suicidal risk we developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). IPT is an evidence-based intervention for various psychopathologies among different age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of 3 months. This paper aims to review the theoretical foundation of this intervention, describe the research design, and present preliminary results of a pilot study. Preliminary Results from our samples of 26 adolescents indicate meaningful trends for both the suicidal ideation (SIQ) and depression (MFQ) outcome measures. Significant interaction was found concerning suicidal ideation but not for depression. Main limitations include small sample size and stratified controls. The treatment appears to be safe, feasible and acceptable and initial results show promising trends to support further study of the approach.

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