Protocol Development Process Research Articles

Assessment of safety climate perception of maintenance workers during major overhauls, outages, shutdowns or turnarounds (MoOSTs)

AbstractMaintenance activities are used to sustain the reliability of physical industrial assets. However, studies indicate that some of the most devastating industrial accidents are attributable to poor safety perceptions of maintenance workers, especially during major overhauls, outages, shutdowns or turnarounds (MoOSTs). Typical MoOSTs involve the harmonisation of regular maintenance endeavours on a large scale, which in turn heighten risks of accidents and costs. Furthermore, MoOSTs are performed over short durations thereby necessitating parallel high‐risk activities by different organisations that have different perceptions of safety and possess different safety cultures. Understanding safety climate can immensely benefit MoOSTs organisations by improving the understanding of attitudes and perceptions that alleviate workplace incidents. This study aimed to establish safety climate that would boost safety culture and positively impact perceived safety performance during MoOSTs. Safety climate questionnaire survey was deployed to MoOSTs workers of leading cement plants in Nigeria. Through exploratory factor analysis, three underlying safety climate factors were identified, which helped to determine that factors such as ‛training and learning from incidents’, ‛commitment of senior management towards ensuring safety and its protocol development process’ and ‛effectiveness of incident reporting systems during MoOSTs’ were significant predictors of workers’ perceptions of safety performance. The findings also pointed out that the inter‐relationship between perceived safety performance, MoOSTs safety training and organisational commitment were positively correlated.

Risk and diagnostic factors and therapy outcome of neonatal early onset sepsis in ICU patients of Saudi Arabia: a systematic review and meta analysis.

Neonatal early onset sepsis (NEOS) is a serious and potentially life-threatening condition affecting newborns within the first few days of life. While the diagnosis of NEOS was based on clinical signs and symptoms in the past, recent years have seen growing interest in identifying specific diagnostic factors and optimizing therapy outcomes. This study aims to investigate the diagnostic and risk factors and therapy outcomes of neonatal EOS in ICU patients in Saudi Arabia, with the goal of improving the management of neonatal EOS in the country. This method outlines the protocol development, search strategy, study selection, and data collection process for a systematic review on neonatal early onset sepsis in Saudi Arabian ICU patients, following the PRISMA 2020 guidelines. PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) is a well-established guideline that provides a framework for conducting systematic reviews and meta-analyses in a transparent and standardized manner. It aims to improve the quality and reporting of such research by ensuring clear and comprehensive reporting of study methods, results, and interpretations. The search strategy included electronic databases (PubMed, Embase, Google Scholar, Science Direct, and the Cochrane Library) and manual search of relevant studies, and data were extracted using a standardized form. The systematic review included 21 studies on neonatal sepsis in Saudi Arabia, with varying study designs, sample sizes, and prevalence rates of sepsis. Group B streptococcus and E. coli were the most commonly isolated pathogens. Various diagnostic factors and risk factors were reported, including hematological parameters, biomarkers, and blood cultures. The quality of the included studies was assessed using the Newcastle-Ottawa Scale and Joanna Briggs Institute critical checklist. The review identified a number of risk and diagnostic factors and therapy outcomes for neonatal sepsis. However, most of the studies were having small scale cohort groups. Further research with controlled study designs is needed to develop effective prevention and management strategies for neonatal sepsis in Saudi Arabia.

FastContext: A tool for identification of adapters and other sequence patterns in next generation sequencing (NGS) data.

The development of next generation sequencing (NGS) methods has created the need for detailed analysis and control of each protocol step. NGS library preparation protocols may include steps with incorporation of various service sequences, such as sequencing adapters, primers, sample-, cell-, and molecule-specific barcodes. Despite a fairly high level of current knowledge, during the protocol development process researches often have to deal with various kinds of unexpected experiment outcomes, which result either from lack of information, lack of knowledge, or defects in reagent manufacturing. Detection and analysis of service sequences, their distribution and linkage may provide important information for protocol optimization. Here we introduce FastContext, a tool designed to analyze NGS read structure, based on sequence features found in reads, and their relative position in the read. The algorithm is able to create human readable read structures with user-specified patterns, to calculate counts and percentage of every read structure. Despite the simplicity of the algorithm, FastContext may be useful in read structure analysis and, as a result, can help better understand molecular processes that take place at different stages of NGS library preparation. The project is open-source software, distributed under GNU GPL v3, entirely written in the programming language Python, and based on well-maintained packages and commonly used data formats. Thus, it is cross-platform, may be patched or upgraded by the user if necessary. The FastContext package is available at the Python Package Index (https://pypi.org/project/FastContext), the source code is available at GitHub (https://github.com/regnveig/FastContext).

A Clinically Optimal Protocol for the Imaging of Enteric Tubes: On the Basis of Radiologist Interpreted Diagnostic Utility and Radiation Dose Reduction

The purpose of this study was to develop and evaluate a patient thickness-based protocol specifically for the confirmation of enteric tube placements in bedside abdominal radiographs. Protocol techniques were set to maintain image quality while minimizing patient dose. A total of 226 pre-intervention radiographs were obtained to serve as a baseline cohort for comparison. After the implementation of a thickness-based protocol, a total of 229 radiographs were obtained as part of an intervention cohort. Radiographs were randomized and graded for diagnostic quality by seven expert radiologists based on a standardized conspicuity scale (grades: 0 non-diagnostic to 3+). Basic patient demographics, body mass index, ventilatory status, and enteric tube type were recorded and subgroup analyses were performed. Effective dose was estimated for both cohorts. The dedicated thickness-based protocol resulted in a significant reduction in effective dose of 80% (p-value < 0.01). There was no significant difference in diagnostic quality between the two cohorts with 209 (92.5%) diagnostic radiographs in the baseline and 221 (96.5%) diagnostic radiographs in the thickness-based protocol (p-value 0.06). A protocol optimized for the confirmation of enteric tube placements was developed. This protocol results in lower patient effective dose, without sacrificing diagnostic accuracy. The technique chart is provided for reference. The protocol development process outlined in this work could be readily generalized to other imaging clinical tasks.

Promoting readiness and engagement in pain rehabilitation for youth and families: Developing a pediatric telehealth motivational interviewing protocol.

ObjectiveIntensive interdisciplinary pain treatment (IIPT) is a promising approach for youth with complex, disabling, refractory pain conditions. However, youth and families who initiate IIPT without sufficient acceptance of its focus on functional rehabilitation or readiness to adopt a self‐management approach to their pain may face challenges in IIPT and/or experience suboptimal outcomes. Motivational interviewing (MI) techniques have been shown to enhance readiness to make a number of health behavior changes for adults and youth, but it has not been systematically examined in the context of pediatric IIPT. The authors developed an MI telehealth intervention protocol explicitly designed to prepare youth and families for admission to IIPT.MethodThe protocol development process is detailed here, including influential models, expert consultation, and feedback from IIPT clinical experts. The intervention protocol was then piloted with a group of eligible families to elicit feedback and prompt further refining. Feasibility and acceptability were explored through measures of treatment engagement and satisfaction.ResultsThe Promoting Readiness and Engagement in Pain Rehabilitation (PREPaRe) intervention protocol contains four modules aimed to enhance youth and parent readiness to adopt a self‐management approach to persistent pain, through a motivational interviewing approach. Initial responses from the test group suggested high levels of treatment engagement and treatment satisfaction with PREPaRe.ConclusionsPREPaRe appears feasible to administer and acceptable to families of youth with persistent pain seeking IIPT. Implications for implementation are discussed. Further study via randomized control trial is warranted.Trial registrationClinicalTrials.gov identifier: NCT04093921.

Assessing the Real-time Influence of Racism-Related Stress and Suicidality Among Black Men: Protocol for an Ecological Momentary Assessment Study.

BackgroundSuicide is the third leading cause of death among Black adults aged 18-35 years. Although men represent a majority of suicide deaths among Black adults, less is known regarding the extent to which unique cultural stressors, such as racism-related stress (eg, racial discrimination), are salient in exacerbating suicide risk among Black men. Moreover, few studies examine the daily influence of racism-related stressors on suicide outcomes using real-time smartphone-based approaches. Smartphone-based mobile health approaches using ecological momentary assessments (EMA) provide an opportunity to assess and characterize racism-related stressors as a culturally sensitive suicide risk factor among Black young adult men.ObjectiveThe goal of this study is to describe a protocol development process that aims to capture real-time racism-related stressors and suicide outcomes using a smartphone-based EMA platform (MetricWire).MethodsGuided by the Interpersonal Theory of Suicide (ITS), we developed a brief EMA protocol using a multiphased approach. First, we conducted a literature review to identify brief measures previously used in EMA studies, with special emphasis on studies including Black participants. The identified measures were then shortened to items with the highest construct validity (eg, factor loadings) and revised to reflect momentary or daily frequency. Feasibility and acceptability of the study protocol will be assessed using self-report survey and qualitative responses. To protect participants from harm, a three-tier safety protocol was developed to identify participants with moderate, elevated, and acute risk based on EMA survey response to trigger outreach by the study coordinator.ResultsThe final EMA protocol, which will be completed over a 7-day period, is comprised of 15 questions administered 4 times per day and a daily questionnaire of 22 items related to sleep-related impairment and disruption, as well as racism-related stress. Study recruitment is currently underway. We anticipate the study will be completed in February 2023. Dissemination will be conducted through peer-reviewed publications and conference presentations.ConclusionsThis protocol will address gaps in our understanding of Black men’s suicide outcomes in the social contexts that they regularly navigate and will clarify the temporal role of racism-related stressors that influence suicidal outcomes.International Registered Report Identifier (IRRID)PRR1-10.2196/31241

Plant Tissue Culture Research and Development in Ethiopia: A Case Study on Current Status, Opportunities, and Challenges

Plant tissue culture (PTC) is one of the well-adapted and practiced biotechnology tools in Ethiopia. After the initial success of tissue culture at the Ethiopian Institute of Agriculture Research and Addis Ababa University, the technology spread its roots to most of the research institutes and universities across the country. Consequently, the technology continues to extend at the commercial level. However, there is a lack of information at the national level on the capacity of national institutes in terms of available infrastructure and skilled human power, the potential of the laboratories for tissue culture-related activities, and existing challenges that hinder tissue culture research and development. This study aimed to assess the status of tissue culture research and development in Ethiopia and identify gaps that hinder its application in various economic sectors. The primary data were collected from 19 tissue culture laboratories across the country using questionnaires and physical observation. Accordingly, the results of the study revealed that Jimma Agricultural Research Center from the federal research institute and Amhara Regional Agriculture Research Institute, Bahir Dar Laboratory, from the regional research institute are relatively well equipped with facilities and equipment for tissue culture R&amp;D activities. Among the commercial laboratories, Tigray Biotechnology Center is well equipped and has the highest production capacity with 40 million seedlings per year. Besides, the assessment revealed that a total of 54 plant species have been under in vitro protocol optimization and development process across all PTC laboratories. Nevertheless, tissue culture application in public and private sectors in Ethiopia is limited by several technical, administrative, and financial constraints. Therefore, to exploit the maximum benefit of PTC technology in the existing facilities, further intervention is critical in solving the identified challenges.

Administration of 3% Sodium Chloride Through Peripheral Intravenous Access: Development and Implementation of a Protocol for Clinical Practice.

Patients with traumatic brain injury, cerebral edema, and severe hyponatremia require rapid augmentation of serum sodium levels. Three percent sodium chloride is commonly used to normalize or augment serum sodium level, yet there are limited data available concerning the most appropriate route of administration. Traditionally, 3% sodium chloride is administered through a central venous catheter (CVC) due to the attributed theoretical risk of phlebitis and extravasation injuries when hyperosmolar solution is administered peripherally. CVCs are associated with numerous complications, including arterial puncture, pneumothorax, infection, thrombosis, and air embolus. Peripherally infused 3% sodium chloride may bypass these concerns. To explore the evidence for peripherally infused 3% sodium chloride and to implement the findings. The Iowa Model of Evidence-Based Practice (EBP) was used to guide the project. A multidisciplinary team was established, and they developed an evidence-based protocol for the administration of 3% sodium chloride using peripheral intravenous catheters (PIVs), identified potential barriers to implementation, and developed targeted education to implement this practice change in a large academic medical center. Of the 103 patients in this project, only three (2.9%) identified adverse events. Two were associated with continuous infusions, and one was associated with a bolus infusion. This is the first study to describe a multidisciplinary protocol development and implementation process for the administration of 3% sodium chloride peripherally. Utilizing a multidisciplinary team is critical to the success of an EBP project. Implementing an evidence-based PIV protocol with stringent monitoring criteria for the administration of 3% sodium chloride has the potential to reduce adverse events related to CVC injury.

Analyzing the Landscape: Community Organizing and Health Equity

In this paper we describe landscape analysis, a participatory research method for public health scholars interested in identifying and elucidating trends, opportunities, and gaps in the field. We used this method to understand the environmental and social conditions of primarily under-resourced communities of color, and identify key organizing strategies and practices used by community organizers to fight for policy and systems change around childhood health equity issues. Using a community-based participatory research approach, we developed and implemented a structured landscape analysis process among a national sample of 45 community-based organizations (CBOs). We discuss in detail our sampling procedures, protocol development, and analysis process. The resulting landscape analysis revealed similar challenges (e.g., lack of adequate housing, poor early childhood education resources) across diverse communities, and the best practices and innovative solutions used by CBOs to address these challenges. The landscape analysis process underscores the important role that social justice grassroots CBOs play in addressing the root causes of health inequity even though they may not identify, or be identified, as “public health” organizations.

Designing an ethnographic interview for evaluation of micronutrient powder trial: Challenges and opportunities for implementation science.

The evidence base for micronutrient powder (MNP) interventions predominantly consists of quantitative studies focused on measuring coverage, utilization, and/or biological outcomes. We need other types of studies to broaden the scope of our knowledge about determinants of MNP programme effectiveness. Addressing this knowledge gap, this paper focuses on the process of designing an ethnographic research protocol to obtain caregivers' perspectives on the factors that influenced their use of intervention delivery services and their adherence to MNP recommendations. The research was undertaken within the context of formative evaluations conducted in Mozambique and Ethiopia. Ethnography provides a means for acquiring and interpreting this knowledge and is an approach particularly well suited for formative evaluation to understand the response of a population to new interventions and programme delivery processes. We describe decisions made and challenges encountered in developing the protocol, and their implications for advancing methodology in implementation research science. In addition to a core team of three investigators, we added an “advisory group” of 10 experts to advise us as we developed the protocol. The advisory group reviewed multiple drafts of the interview protocol and participated in mock interviews. In the protocol development process, we faced the issues and made decisions about concerned gaps in content, cultural adaptations and comprehension, and interview guide structure and format. Differences between the core team and the advisory group in methodological approaches to the structure and content of questions call attention to the importance of establishing greater communication among implementation scientists working in nutrition interventions.

PO 8515 CAPACITY BUILDING IN PREPARATION FOR AN HIV VACCINE TRIAL: THE GLOBALLY RELEVANT AIDS VACCINE EUROPE-AFRICA TRIALS PARTNERSHIP (GREAT)

BackgroundThe Globally Relevant AIDS Vaccine Europe-Africa Trials (GREAT) partnership is an EDCTP-funded project that aims to foster collaboration between institutions in Europe and sub-Saharan Africa to build capacity among African clinical research centres (CRCs) for the design and conduct of HIV-1 vaccine efficacy trials.MethodsIn January 2017, the University of Oxford (UOXF) and five CRCs in Kenya, Uganda and Zambia were awarded a 5 year grant for capacity building and to support conduct of an HIV-1 vaccine trial in different high-risk populations across Africa using cross-clade (conserved protein regions) T-cell vaccines. UOXF and CRCs embarked on activities to strengthen capacity of the CRCs for future efficacy trials. This included training, community engagement, cohort preparation and infrastructure upgrade.ResultsIn the first year, the African investigators at the CRCs collaborated on the development of a protocol aimed at assessing the safety and immunogenicity of the tHIVconsvX vaccines. In preparation for the planned vaccine trial, infrastructure upgrades were prioritised at all partner sites and this included building laboratory space and procurement of appropriate laboratory equipment. Planned infrastructure upgrades will also ensure that high-risk populations can be safely and confidentially included in HIV prevention clinical trials. Systematic community engagement was implemented at all sites, training in GCP/GCLP was provided and training is planned for nominated CRC staff to lead community engagement efforts.ConclusionImproved infrastructure and the provision of targeted training will enhance future trials and increase the capacities of CRCs and staff to conduct quality trials in previously hard-to-reach populations. Early collaboration between investigators from European and sub-Saharan African institutions, with equal responsibilities in the protocol development process, established a meaningful partnership. EDCTP funding also offers a unique opportunity for capacity building.

Avocadoes and Chinese cuisine

This paper presents the results of qualitative research undertaken in Singapore with consumers from various Asian ethnic backgrounds, with emphasis on Chinese-ethnic consumers. The study provides an understanding of consumers’ attitudes, behaviours and beliefs towards avocadoes Persea americana). It also presents the results of unstructured interviews conducted with representatives of the food service industry in Singapore. The study found that although avocados are gaining popularity in Asian markets consumption is still relatively low, with only a small portion of consumers purchasing them regularly. Avocados are not popular with Chinese consumers, as most find it hard to integrate the fruit in Chinese cooking. Avocados are not commonly used in Asian cuisine and are only used for entertaining guests during gatherings. Furthermore, as avocados are known as ‘butter fruit’ in Chinese, there are misconceptions as to the negative health aspects of the fruit. The Australian avocado industry is taking active steps to gain market access to the expanding Asian consumer market. As the phytosanitary protocol development process is time consuming, costly and resource intensive, the industry needs to ensure that such investment translates into trade success. Understanding consumer’s attitudes and interaction with avocados in the first step to plan market development activities and ensure export success. This study concludes that to increase avocado consumption with consumers from Chinese background, greater awareness of the different uses of avocados is needed and more consumer information is required to dispel any confusion about the health attributes of the fruit.

Development of New Trial Protocol Development Process Chart using Quality by Design method

Development of New Trial Protocol Development Process Chart using Quality by Design method

Protocol for Monitoring Tropical Forest Restoration

Monitoring protocols are needed to evaluate the millions of hectares of land that are being proposed for forest restoration in the coming decades. Standardized proposals are critical to evaluate efficacy of restoration strategies, identify triggers for corrective actions, compare results across projects, and generally learn from past projects to inform future restoration efforts. We describe an iterative process, including over 200 stakeholders, to develop a protocol for monitoring Brazilian Atlantic Forest restoration. We give an overview of the ecological, socioeconomic, and management criteria, indicators, and metrics included in the protocol. Strengths of the protocol include the following: (a) testing and use across sites with a range of ages, forest types, past land uses, restoration techniques, and implementing institutions; (b) participation by a broad range of government, nongovernment, private, and academic institutions in the protocol development process; and (c) inclusion of socioeconomic and management criteria. Next steps for facilitating the broad adoption of the protocol in the Atlantic Forest region include providing in person and online training courses, establishing an online repository for storing and comparing monitoring data, and developing smartphone applications to facilitate data collection. Although the protocol was developed for the Atlantic Forest context and further refinements are needed, we think that the Atlantic Forest Pact monitoring protocol may serve as a model to inform the development of similar protocols in other regions, which ultimately could be integrated to produce a pantropical protocol for common use by several restoration forest programs worldwide.

How a CT-Direct Protocol at an American Comprehensive Stroke Center Led to Door-to-Needle Times Less Than 30 Minutes.

The safety and efficacy of intravenous tissue plasminogen activator (IV tPA) following acute ischemic stroke (AIS) is dependent on its timely administration. In 2014, our Comprehensive Stroke Center designed and implemented a computed tomography-Direct protocol to streamline the evaluation process of suspected patients with AIS, with the aim of reducing door-to-needle (DTN) times. The objectives of our study were to describe the protocol development and implementation process, and to compare DTN times and symptomatic intracranial hemorrhage (sICH) rates before and after protocol implementation. Data were prospectively collected for patients with AIS receiving IV tPA between January 1, 2010, and May 31, 2015. The DTN times, examined as median times and time treatment windows, and sICH rates were compared pre- and postimplementation. Two hundred ninety-five patients were included in the study. After protocol implementation, median DTN times were significantly reduced (38 vs 28 minutes; P < .001). The distribution of patients treated in the three time treatment windows described below changed significantly, with an increase in patients with DTN times of 30 minutes or less, and a decrease in patients with DTN times 31 to 60 minutes and over 60 minutes (P < .001). There were two cases of sICH prior to implementation and one sICH case postimplementation. The implementation of a protocol that streamlined the processing of suspected patients with AIS significantly reduced DTN time without negatively impacting patient safety.

A Guide to Writing a Qualitative Systematic Review Protocol to Enhance Evidence-Based Practice in Nursing and Health Care.

The qualitative systematic review is a rapidly developing area of nursing research. In order to present trustworthy, high-quality recommendations, such reviews should be based on a review protocol to minimize bias and enhance transparency and reproducibility. Although there are a number of resources available to guide researchers in developing a quantitative review protocol, very few resources exist for qualitative reviews. To guide researchers through the process of developing a qualitative systematic review protocol, using an example review question. The key elements required in a systematic review protocol are discussed, with a focus on application to qualitative reviews: Development of a research question; formulation of key search terms and strategies; designing a multistage review process; critical appraisal of qualitative literature; development of data extraction techniques; and data synthesis. The paper highlights important considerations during the protocol development process, and uses a previously developed review question as a working example. This paper will assist novice researchers in developing a qualitative systematic review protocol. By providing a worked example of a protocol, the paper encourages the development of review protocols, enhancing the trustworthiness and value of the completed qualitative systematic review findings. Qualitative systematic reviews should be based on well planned, peer reviewed protocols to enhance the trustworthiness of results and thus their usefulness in clinical practice. Protocols should outline, in detail, the processes which will be used to undertake the review, including key search terms, inclusion and exclusion criteria, and the methods used for critical appraisal, data extraction and data analysis to facilitate transparency of the review process. Additionally, journals should encourage and support the publication of review protocols, and should require reference to a protocol prior to publication of the review results.

A provincial adaptation of clinical practice guidelines for depression in primary care: a case illustration of the ADAPTE method.

Mental health services for patients with a major depressive disorder are commonly delivered by primary care. To support the uptake of clinical practice guidelines in primary care, we developed and disseminated a practice protocol for depression tailored for a multidisciplinary audience of primary mental health care providers with the ADAPTE methodology. The research questions addressed in this study aimed at examining the experience of the development process of a mental health practice protocol in terms of adaptation, facilitation and implementation. We present a descriptive case study of the development and implementation of a practice protocol for major depressive disorder for primary mental health care in the organizational and cultural context of the province of Québec (Canada), following the steps of the ADAPTE methodology. An expert committee composed of general practitioners, mental health specialists, health care administrators and decision makers at regional and provincial levels participated in the protocol development process. The practice protocol was based on two clinical practice guidelines: the NICE guideline on the treatment and management of depression in adults (2009, 2010) and the Canadian Network for Mood and Anxiety Treatments clinical guidelines for the management of major depressive disorder in adults (2009). A stepped care model was embedded in the protocol to facilitate the implementation of clinical recommendations in primary mental health care. A multifaceted dissemination strategy was used to support the uptake of the protocol recommendations in clinical practice. The ADAPTE methodology provided structure, rigour and efficiency to the trans-contextual adaptation of guideline recommendations. We will share the challenges associated with the adaptation of clinical recommendations and organizational strategies for a mental health guideline, and the dissemination of the practice protocol in primary care.

The Acute Fatigue Response to Bilateral Knee Extensions with Various Blood Flow Restriction Settings

PURPOSE: To examine the acute effects of different blood flow restriction (BFR) settings on neuromuscular activation (changes in motor unit activation and median frequency), and fatigue response during bilateral knee extension exercise. METHODS: Sixteen male (age= 26.63 (5.8) yr) participants performed four sets of bilateral knee extensions on three separate occasions separated by at least 48 hours with the following randomized conditions: Initial tightness of cuffs (Initial restrictive pressure, IRP) at 50 mmHg with the recommended final inflated pressure (final restrictive pressure, FRP) based on thigh circumference plus 20 mmHg ([email protected]+20), IRP of 65 mmHg and the recommended FRP minus 20 mmHg ([email protected]), and at 50 mmHg with the recommended final inflated pressure based on thigh circumference (IRP50, Control). The first day included measuring thigh circumference and one repetition maximum (1RM) for bilateral leg extension. 1RM was recorded through multiple RM testing. The subject’s skin was then prepared for electromyography (EMG) electrode placement by shaving, abrading, and cleansing the electrode site with alcohol. Exercise consisted of four sets of bilateral knee extension exercises at 20% 1RM on the three following days. The first set contained 30 repetitions while the following three sets contained 15 repetitions each. Maximal voluntary contraction (MVC) was recorded pre and post exercise. EMG was recorded at the vastus lateralis during knee extension exercises and MVCs, one-third the distance between the greater trochanter and lateral epicondyle. RESULTS: No significance was found between the conditions in RMS or MDF during sets one through four (p>0.05). A trend for condition main effect (p<0.083) was discovered for RMS during MVC for [email protected] A significant condition main effect (p<0.03) was discovered for torque values during [email protected] CONCLUSION: The condition [email protected] created the greatest levels of fatigue when compared to the other conditions. This may indicate that IRP may be a greater indicator of fatigue as opposed to FRP. This suggests that more research must be done including IRP in the protocol development process.

Compliance with AAPM Practice Guideline 1.a: CT Protocol Management and Review - from the perspective of a university hospital.

The purpose of this paper is to describe our experience with the AAPM Medical Physics Practice Guideline 1.a: “CT Protocol Management and Review Practice Guideline”. Specifically, we will share how our institution's quality management system addresses the suggestions within the AAPM practice report. We feel this paper is needed as it was beyond the scope of the AAPM practice guideline to provide specific details on fulfilling individual guidelines. Our hope is that other institutions will be able to emulate some of our practices and that this article would encourage other types of centers (e.g., community hospitals) to share their methodology for approaching CT protocol optimization and quality control. Our institution had a functioning CT protocol optimization process, albeit informal, since we began using CT. Recently, we made our protocol development and validation process compliant with a number of the ISO 9001:2008 clauses and this required us to formalize the roles of the members of our CT protocol optimization team. We rely heavily on PACS‐based IT solutions for acquiring radiologist feedback on the performance of our CT protocols and the performance of our CT scanners in terms of dose (scanner output) and the function of the automatic tube current modulation. Specific details on our quality management system covering both quality control and ongoing optimization have been provided. The roles of each CT protocol team member have been defined, and the critical role that IT solutions provides for the management of files and the monitoring of CT protocols has been reviewed. In addition, the invaluable role management provides by being a champion for the project has been explained; lack of a project champion will mitigate the efforts of a CT protocol optimization team. Meeting the guidelines set forth in the AAPM practice guideline was not inherently difficult, but did, in our case, require the cooperation of radiologists, technologists, physicists, IT, administrative staff, and hospital management. Some of the IT solutions presented in this paper are novel and currently unique to our institution.PACS number: 87.57.Q

Use of Crowdsourcing for Cancer Clinical Trial Development

Patient and physician awareness and acceptance of trials and patient ineligibility are major cancer clinical trial accrual barriers. Yet, trials are typically conceived and designed by small teams of researchers with limited patient input. We hypothesized that through crowdsourcing, the intellectual and creative capacity of a large number of researchers, clinicians, and patients could be harnessed to improve the clinical trial design process. In this study, we evaluated the feasibility and utility of using an internet-based crowdsourcing platform to inform the design of a clinical trial exploring an antidiabetic drug, metformin, in prostate cancer. Over a six-week period, crowd-sourced input was collected from 60 physicians/researchers and 42 patients/advocates leading to several major (eg, eligibility) and minor modifications to the clinical trial protocol as originally designed. Crowdsourcing clinical trial design is feasible, adds value to the protocol development process, and may ultimately improve the efficiency of trial conduct.