A proposed protocol for acceptance and constancy control of computed tomography systems: a Nordic Association for Clinical Physics (NACP) work group report.

PubMed

Kuttner, Samuel; Bujila, Robert; Kortesniemi, Mika; Andersson, Henrik; Kull, Love; Østerås, Bjørn Helge; Thygesen, Jesper; Tarp, Ivanka Sojat

2013-03-01

Quality assurance (QA) of computed tomography (CT) systems is one of the routine tasks for medical physicists in the Nordic countries. However, standardized QA protocols do not yet exist and the QA methods, as well as the applied tolerance levels, vary in scope and extent at different hospitals. To propose a standardized protocol for acceptance and constancy testing of CT scanners in the Nordic Region. Following a Nordic Association for Clinical Physics (NACP) initiative, a group of medical physicists, with representatives from four Nordic countries, was formed. Based on international literature and practical experience within the group, a comprehensive standardized test protocol was developed. The proposed protocol includes tests related to the mechanical functionality, X-ray tube, detector, and image quality for CT scanners. For each test, recommendations regarding the purpose, equipment needed, an outline of the test method, the measured parameter, tolerance levels, and the testing frequency are stated. In addition, a number of optional tests are briefly discussed that may provide further information about the CT system. Based on international references and medical physicists' practical experiences, a comprehensive QA protocol for CT systems is proposed, including both acceptance and constancy tests. The protocol may serve as a reference for medical physicists in the Nordic countries.

Evolution of a Patient Information Management System in a Local Area Network Environment at Loyola University of Chicago Medical Center

PubMed Central

Price, Ronald N; Chandrasekhar, Arcot J; Tamirisa, Balaji

1990-01-01

The Department of Medicine at Loyola University Medical Center (LUMC) of Chicago has implemented a local area network (LAN) based Patient Information Management System (PIMS) as part of its integrated departmental database management system. PIMS consists of related database applications encompassing demographic information, current medications, problem lists, clinical data, prior events, and on-line procedure results. Integration into the existing departmental database system permits PIMS to capture and manipulate data in other departmental applications. Standardization of clinical data is accomplished through three data tables that verify diagnosis codes, procedures codes and a standardized set of clinical data elements. The modularity of the system, coupled with standardized data formats, allowed the development of a Patient Information Protocol System (PIPS). PIPS, a userdefinable protocol processor, provides physicians with individualized data entry or review screens customized for their specific research protocols or practice habits. Physician feedback indicates that the PIMS/PIPS combination enhances their ability to collect and review specific patient information by filtering large amount of clinical data.

ABM Clinical Protocol #21: Guidelines for Breastfeeding and the Drug-Dependent Woman

PubMed Central

2009-01-01

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:19835481

ABM Clinical Protocol #19: Breastfeeding Promotion in the Prenatal Setting, Revision 2015

PubMed Central

Rosen-Carole, Casey; Hartman, Scott

2015-01-01

A central goal of the Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:26651541

Optimization of protocol design: a path to efficient, lower cost clinical trial execution

PubMed Central

Malikova, Marina A

2016-01-01

Managing clinical trials requires strategic planning and efficient execution. In order to achieve a timely delivery of important clinical trials’ outcomes, it is useful to establish standardized trial management guidelines and develop robust scoring methodology for evaluation of study protocol complexity. This review will explore the challenges clinical teams face in developing protocols to ensure that the right patients are enrolled and the right data are collected to demonstrate that a drug is safe and efficacious, while managing study costs and study complexity based on proposed comprehensive scoring model. Key factors to consider when developing protocols and techniques to minimize complexity will be discussed. A methodology to identify processes at planning phase, approaches to increase fiscal return and mitigate fiscal compliance risk for clinical trials will be addressed. PMID:28031939

CT and MR Protocol Standardization Across a Large Health System: Providing a Consistent Radiologist, Patient, and Referring Provider Experience.

PubMed

Sachs, Peter B; Hunt, Kelly; Mansoubi, Fabien; Borgstede, James

2017-02-01

Building and maintaining a comprehensive yet simple set of standardized protocols for a cross-sectional image can be a daunting task. A single department may have difficulty preventing "protocol creep," which almost inevitably occurs when an organized "playbook" of protocols does not exist and individual radiologists and technologists alter protocols at will and on a case-by-case basis. When multiple departments or groups function in a large health system, the lack of uniformity of protocols can increase exponentially. In 2012, the University of Colorado Hospital formed a large health system (UCHealth) and became a 5-hospital provider network. CT and MR imaging studies are conducted at multiple locations by different radiology groups. To facilitate consistency in ordering, acquisition, and appearance of a given study, regardless of location, we minimized the number of protocols across all scanners and sites of practice with a clinical indication-driven protocol selection and standardization process. Here we review the steps utilized to perform this process improvement task and insure its stability over time. Actions included creation of a standardized protocol template, which allowed for changes in electronic storage and management of protocols, designing a change request form, and formation of a governance structure. We utilized rapid improvement events (1 day for CT, 2 days for MR) and reduced 248 CT protocols into 97 standardized protocols and 168 MR protocols to 66. Additional steps are underway to further standardize output and reporting of imaging interpretation. This will result in an improved, consistent radiologist, patient, and provider experience across the system.

Assessing and Managing Risk with Suicidal Individuals

ERIC Educational Resources Information Center

Linehan, Marsh M.; Comtois, Katherine A.; Ward-Ciesielski, Erin F.

2012-01-01

The University of Washington Risk Assessment Protocol (UWRAP) and Risk Assessment and Management Protocol (UWRAMP) have been used in numerous clinical trials treating high-risk suicidal individuals over several years. These protocols structure assessors and treatment providers to provide a thorough suicide risk assessment, review standards of care…

Evaluating the Process of Generating a Clinical Trial Protocol

PubMed Central

Franciosi, Lui G.; Butterfield, Noam N.; MacLeod, Bernard A.

2002-01-01

The research protocol is the principal document in the conduct of a clinical trial. Its generation requires knowledge about the research problem, the potential experimental confounders, and the relevant Good Clinical Practices for conducting the trial. However, such information is not always available to authors during the writing process. A checklist of over 80 items has been developed to better understand the considerations made by authors in generating a protocol. It is based on the most cited requirements for designing and implementing the randomised controlled trial. Items are categorised according to the trial's research question, experimental design, statistics, ethics, and standard operating procedures. This quality assessment tool evaluates the extent that a generated protocol deviates from the best-planned clinical trial.

ABM Clinical Protocol #21: Guidelines for Breastfeeding and Substance Use or Substance Use Disorder, Revised 2015

PubMed Central

2015-01-01

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:25836677

Hospital protocols for targeted glycemic control: Development, implementation, and models for cost justification.

PubMed

Magee, Michelle F

2007-05-15

Evolving elements of best practices for providing targeted glycemic control in the hospital setting, clinical performance measurement, basal-bolus plus correction-dose insulin regimens, components of standardized subcutaneous (s.c.) insulin order sets, and strategies for implementation and cost justification of glycemic control initiatives are discussed. Best practices for targeted glycemic control should address accurate documentation of hyperglycemia, initial patient assessment, management plan, target blood glucose range, blood glucose monitoring frequency, maintenance of glycemic control, criteria for glucose management consultations, and standardized insulin order sets and protocols. Establishing clinical performance measures, including desirable processes and outcomes, can help ensure the success of targeted hospital glycemic control initiatives. The basal-bolus plus correction-dose regimen for insulin administration will be used to mimic the normal physiologic pattern of endogenous insulin secretion. Standardized insulin order sets and protocols are being used to minimize the risk of error in insulin therapy. Components of standardized s.c. insulin order sets include specification of the hyperglycemia diagnosis, finger stick blood glucose monitoring frequency and timing, target blood glucose concentration range, cutoff values for excessively high or low blood glucose concentrations that warrant alerting the physician, basal and prandial or nutritional (i.e., bolus) insulin, correction doses, hypoglycemia treatment, and perioperative or procedural dosage adjustments. The endorsement of hospital administrators and key physician and nursing leaders is needed for glycemic control initiatives. Initiatives may be cost justified on the basis of the billings for clinical diabetes management services and/or the return- on-investment accrued to reductions in hospital length of stay, readmissions, and accurate documentation and coding of unrecognized or uncontrolled diabetes, and diabetes complications. Standardized insulin order sets and protocols may minimize risk of insulin errors. The endorsement of these protocols by administrators, physicians, nurses, and pharmacists is also needed for success.

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

PubMed

Zhang, Yan; Phy, Jennifer; Scott-Johnson, Chris; Garos, Sheila; Orlando, Jennie; Prien, Samuel; Huang, Jaou-Chen

2017-04-04

The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to assess the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF. This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively. Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule. ClinicalTrials NCT02591186 registered on October 7, 2015.

Pretreatment with low-energy shock waves induces renal vasoconstriction during standard SWL: a treatment protocol known to reduce lithotripsy-induced renal injury

PubMed Central

Handa, Rajash K.; Bailey, Michael R.; Paun, Marla; Gao, Sujuan; Connors, Bret A.; Willis, Lynn R.; Evan, Andrew P.

2008-01-01

Introduction and Objective A great deal of effort has been focused on developing new treatment protocols to reduce tissue injury to improve the safety of shock wave lithotripsy. This has led to the discovery that pretreatment of the kidney with a series of low-energy shock waves (SWs) will substantially reduce the hemorrhagic lesion that normally results from a standard clinical dose of high-energy SWs. Because renal blood flow is reduced following low- or high-energy SWL, and may therefore contribute to this effect, this study was designed to test the hypothesis that the pretreatment protocol induces renal vasoconstriction sooner than the standard protocol for SW delivery. Methods Female farm pigs (6-weeks old) were anesthetized with isoflurane and the lower pole of the right kidney treated with SWs using the HM3 lithotripter. Pulsed Doppler sonography was used to measure resistive index (RI) in blood vessels as a reflection of resistance/impedance to blood flow. RI was recorded from a single intralobar artery located in the targeted pole of the kidney, and measurements taken from pigs given sham SW treatment (Group 1; no SWs, n = 4), a standard clinical dose of high-energy SWs (Group 2; 2000 SWs, 24 kV, 120 SWs/min, n = 7), low-energy SW pretreatment followed by high-energy SWL (Group 3; 500 SWs, 12 kV, 120 SWs/min + 2000 SWs, 24 kV, 120 SWs/min, n = 8) and low-energy SW pretreatment alone (Group 4; 500 SWs, 12 kV, 120 SWs/min, n = 6). Results Baseline RI (~ 0.61) was similar for all groups. Pigs receiving sham SW treatment (Group 1) had no significant change in RI. A standard clinical dose of high-energy SWs (Group 2) did not significantly alter RI during treatment, but did increase RI at 45-min into the post-SWL period. Low-energy SWs did not alter RI in Group 3 pigs, but subsequent treatment with a standard clinical dose of high-energy SWs resulted in a significantly earlier (at 1000 SWs) and greater (two-fold) rise in RI than that observed in Group 2 pigs. This rise in RI during the low/high-energy SWL treatment protocol was not due to a delayed vasoconstrictor response of pretreatment, as low-energy SW treatment alone (Group 4) did not increase RI until 65 min into the post-SWL period. Conclusions The pretreatment protocol induces renal vasoconstriction during the period of SW application whereas the standard protocol shows vasoconstriction occurring only during the post-SWL period. Thus the earlier and greater rise in RI during the pretreatment protocol may be causally associated with a reduction in tissue injury. PMID:19154458

Development and implementation of clinical trial protocol templates at the National Institute of Allergy and Infectious Diseases.

PubMed

Bridge, Heather; Smolskis, Mary; Bianchine, Peter; Dixon, Dennis O; Kelly, Grace; Herpin, Betsey; Tavel, Jorge

2009-08-01

A clinical research protocol document must reflect both sound scientific rationale as well as local, national and, when applicable, international regulatory and human subject protections requirements. These requirements originate from a variety of sources, undergo frequent revision and are subject to interpretation. Tools to assist clinical investigators in the production of clinical protocols could facilitate navigating these requirements and ultimately increase the efficiency of clinical research. The National Institute of Allergy and Infectious Diseases (NIAID) developed templates for investigators to serve as the foundation for protocol development. These protocol templates are designed as tools to support investigators in developing clinical protocols. NIAID established a series of working groups to determine how to improve its capacity to conduct clinical research more efficiently and effectively. The Protocol Template Working Group was convened to determine what protocol templates currently existed within NIAID and whether standard NIAID protocol templates should be produced. After review and assessment of existing protocol documents and requirements, the group reached consensus about required and optional content, determined the format and identified methods for distribution as well as education of investigators in the use of these templates. The templates were approved by the NIAID Executive Committee in 2006 and posted as part of the NIAID Clinical Research Toolkit [1] website for broad access. These documents require scheduled revisions to stay current with regulatory and policy changes. The structure of any clinical protocol template, whether comprehensive or specific to a particular study phase, setting or design, affects how it is used by investigators. Each structure presents its own set of advantages and disadvantages. While useful, protocol templates are not stand-alone tools for creating an optimal protocol document, but must be complemented by institutional resources and support. Education and guidance of investigators in the appropriate use of templates is necessary to ensure a complete yet concise protocol document. Due to changing regulatory requirements, clinical protocol templates cannot become static, but require frequent revisions.

The Interface of Clinical Decision-Making With Study Protocols for Knowledge Translation From a Walking Recovery Trial.

PubMed

Hershberg, Julie A; Rose, Dorian K; Tilson, Julie K; Brutsch, Bettina; Correa, Anita; Gallichio, Joann; McLeod, Molly; Moore, Craig; Wu, Sam; Duncan, Pamela W; Behrman, Andrea L

2017-01-01

Despite efforts to translate knowledge into clinical practice, barriers often arise in adapting the strict protocols of a randomized, controlled trial (RCT) to the individual patient. The Locomotor Experience Applied Post-Stroke (LEAPS) RCT demonstrated equal effectiveness of 2 intervention protocols for walking recovery poststroke; both protocols were more effective than usual care physical therapy. The purpose of this article was to provide knowledge-translation tools to facilitate implementation of the LEAPS RCT protocols into clinical practice. Participants from 2 of the trial's intervention arms: (1) early Locomotor Training Program (LTP) and (2) Home Exercise Program (HEP) were chosen for case presentation. The two cases illustrate how the protocols are used in synergy with individual patient presentations and clinical expertise. Decision algorithms and guidelines for progression represent the interface between implementation of an RCT standardized intervention protocol and clinical decision-making. In each case, the participant presents with a distinct clinical challenge that the therapist addresses by integrating the participant's unique presentation with the therapist's expertise while maintaining fidelity to the LEAPS protocol. Both participants progressed through an increasingly challenging intervention despite their own unique presentation. Decision algorithms and exercise progression for the LTP and HEP protocols facilitate translation of the RCT protocol to the real world of clinical practice. The two case examples to facilitate translation of the LEAPS RCT into clinical practice by enhancing understanding of the protocols, their progression, and their application to individual participants.Video Abstract available for more insights from the authors (see Supplemental Digital Content 1, available at: http://links.lww.com/JNPT/A147).

ABM Clinical Protocol #1: Guidelines for Blood Glucose Monitoring and Treatment of Hypoglycemia in Term and Late-Preterm Neonates, Revised 2014

PubMed Central

Wight, Nancy

2014-01-01

A central goal of The Academy of Breastfeeding Medicine is the development of clinical protocols for managing common medical problems that may impact breastfeeding success. These protocols serve only as guidelines for the care of breastfeeding mothers and infants and do not delineate an exclusive course of treatment or serve as standards of medical care. Variations in treatment may be appropriate according to the needs of an individual patient. PMID:24823918

A literature review: polypharmacy protocol for primary care.

PubMed

Skinner, Mary

2015-01-01

The purpose of this literature review is to critically evaluate published protocols on polypharmacy in adults ages 65 and older that are currently used in primary care settings that may potentially lead to fewer adverse drug events. A review of OVID, CINAHL, EBSCO, Cochrane Library, Medline, and PubMed databases was completed using the following key words: protocol, guideline, geriatrics, elderly, older adult, polypharmacy, and primary care. Inclusion criteria were: articles in medical, nursing, and pharmacology journals with an intervention, protocol, or guideline addressing polypharmacy that lead to fewer adverse drug events. Qualitative and quantitative studies were included. Exclusion criteria were: publications prior to the year 1992. A gap exists in the literature. No standardized protocol for addressing polypharmacy in the primary care setting was found. Mnemonics, algorithms, clinical practice guidelines, and clinical strategies for addressing polypharmacy in a variety of health care settings were found throughout the literature. Several screening instruments for use in primary care to assess potentially inappropriate prescription of medications in the elderly, such as the Beers Criteria and the STOPP screening tool, were identified. However, these screening instruments were not included in a standardized protocol to manage polypharmacy in primary care. Polypharmacy in the elderly is a critical problem that may result in adverse drug events such as falls, hospitalizations, and increased expenditures for both the patient and the health care system. No standardized protocols to address polypharmacy specific to the primary care setting were identified in this review of the literature. Given the growing population of elderly in this country and the high number of medications they consume, it is critical to focus on the utilization of a standardized protocol to address the potential harm of polypharmacy in the primary care setting and evaluate its effects on patient outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.

Protocols | Office of Cancer Clinical Proteomics Research

Cancer.gov

Each reagent on the Antibody Portal has been characterized by a combination of methods specific for that antibody. To view the customized antibody methods and protocols (Standard Operating Procedures) used to generate and characterize each reagent, select an antibody of interest and open the protocols associated with their respective characterization methods along with characterization data.

Pretreatment with low-energy shock waves induces renal vasoconstriction during standard shock wave lithotripsy (SWL): a treatment protocol known to reduce SWL-induced renal injury.

PubMed

Handa, Rajash K; Bailey, Michael R; Paun, Marla; Gao, Sujuan; Connors, Bret A; Willis, Lynn R; Evan, Andrew P

2009-05-01

To test the hypothesis that the pretreatment of the kidney with low-energy shock waves (SWs) will induce renal vasoconstriction sooner than a standard clinical dose of high-energy SWs, thus providing a potential mechanism by which the pretreatment SW lithotripsy (SWL) protocol reduces tissue injury. Female farm pigs (6-weeks-old) were anaesthetized with isoflurane and the lower pole of the right kidney treated with SWs using a conventional electrohydraulic lithotripter (HM3, Dornier GmbH, Germany). Pulsed Doppler ultrasonography was used to measure renal resistive index (RI) in blood vessels as a measure of resistance/impedance to blood flow. RI was recorded from one intralobar artery located in the targeted pole of the kidney, and measurements taken from pigs given sham SW treatment (Group 1; no SWs, four pigs), a standard clinical dose of high-energy SWs (Group 2; 2000 SWs, 24 kV, 120 SWs/min, seven pigs), low-energy SW pretreatment followed by high-energy SWL (Group 3; 500 SWs, 12 kV, 120 SWs/min + 2000 SWs, 24 kV, 120 SWs/min, eight pigs) and low-energy SW pretreatment alone (Group 4; 500 SWs, 12 kV, 120 SWs/min, six pigs). Baseline RI (approximately 0.61) was similar for all groups. Pigs receiving sham SW treatment (Group 1) had no significant change in RI. A standard clinical dose of high-energy SWs (Group 2) did not significantly alter RI during treatment, but did increase RI at 45 min after SWL. Low-energy SWs did not alter RI in Group 3 pigs, but subsequent treatment with a standard clinical dose of high-energy SWs resulted in a significantly earlier (at 1000 SWs) and greater (two-fold) rise in RI than that in Group 2 pigs. This rise in RI during the low/high-energy SWL protocol was not due to a delayed vasoconstrictor response of pretreatment, as low-energy SW treatment alone (Group 4) did not increase RI until 65 min after SWL. The pretreatment protocol induces renal vasoconstriction during the period of SW application whereas the standard protocol shows vasoconstriction occurring after SWL. Thus, the earlier and greater rise in RI during the pretreatment protocol may be causally associated with a reduction in tissue injury.

Does the Concept of the "Flipped Classroom" Extend to the Emergency Medicine Clinical Clerkship?

PubMed

Heitz, Corey; Prusakowski, Melanie; Willis, George; Franck, Christopher

2015-11-01

Linking educational objectives and clinical learning during clerkships can be difficult. Clinical shifts during emergency medicine (EM) clerkships provide a wide variety of experiences, some of which may not be relevant to recommended educational objectives. Students can be directed to standardize their clinical experiences, and this improves performance on examinations. We hypothesized that applying a "flipped classroom" model to the clinical clerkship would improve performance on multiple-choice testing when compared to standard learning. Students at two institutions were randomized to complete two of four selected EM clerkship topics in a "flipped fashion," and two others in a standard fashion. For flipped topics, students were directed to complete chief complaint-based asynchronous modules prior to a shift, during which they were directed to focus on the chief complaint. For the other two topics, modules were to be performed at the students' discretion, and shifts would not have a theme. At the end of the four-week clerkship, a 40-question multiple-choice examination was administered with 10 questions per topic. We compared performance on flipped topics with those performed in standard fashion. Students were surveyed on perceived effectiveness, ability to follow the protocol, and willingness of preceptors to allow a chief-complaint focus. Sixty-nine students participated; examination scores for 56 were available for analysis. For the primary outcome, no difference was seen between the flipped method and standard (p=0.494.) A mixed model approach showed no effect of flipped status, protocol adherence, or site of rotation on the primary outcome of exam scores. Students rated the concept of the flipped clerkship highly (3.48/5). Almost one third (31.1%) of students stated that they were unable to adhere to the protocol. Preparation for a clinical shift with pre-assigned, web-based learning modules followed by an attempt at chief-complaint-focused learning during a shift did not result in improvements in performance on a multiple-choice assessment of knowledge; however, one third of participants did not adhere strictly to the protocol. Future investigations should ensure performance of pre-assigned learning as well as clinical experiences, and consider alternate measures of knowledge.

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

PubMed Central

Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleža-Jerić, Karmela; Laupacis, Andreas; Moher, David

2013-01-01

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders. PMID:23303884

SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials.

PubMed

Chan, An-Wen; Tetzlaff, Jennifer M; Gøtzsche, Peter C; Altman, Douglas G; Mann, Howard; Berlin, Jesse A; Dickersin, Kay; Hróbjartsson, Asbjørn; Schulz, Kenneth F; Parulekar, Wendy R; Krleza-Jeric, Karmela; Laupacis, Andreas; Moher, David

2013-01-08

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review for the benefit of all stakeholders.

Data standards for clinical research data collection forms: current status and challenges.

PubMed

Richesson, Rachel L; Nadkarni, Prakash

2011-05-01

Case report forms (CRFs) are used for structured-data collection in clinical research studies. Existing CRF-related standards encompass structural features of forms and data items, content standards, and specifications for using terminologies. This paper reviews existing standards and discusses their current limitations. Because clinical research is highly protocol-specific, forms-development processes are more easily standardized than is CRF content. Tools that support retrieval and reuse of existing items will enable standards adoption in clinical research applications. Such tools will depend upon formal relationships between items and terminological standards. Future standards adoption will depend upon standardized approaches for bridging generic structural standards and domain-specific content standards. Clinical research informatics can help define tools requirements in terms of workflow support for research activities, reconcile the perspectives of varied clinical research stakeholders, and coordinate standards efforts toward interoperability across healthcare and research data collection.

Effect of a Standardized Protocol of Antibiotic Therapy on Surgical Site Infection after Laparoscopic Surgery for Complicated Appendicitis.

PubMed

Park, Hyoung-Chul; Kim, Min Jeong; Lee, Bong Hwa

Although it is accepted that complicated appendicitis requires antibiotic therapy to prevent post-operative surgical infections, consensus protocols on the duration and regimens of treatment are not well established. This study aimed to compare the outcome of post-operative infectious complications in patients receiving old non-standardized and new standard antibiotic protocols, involving either 5 or 10 days of treatment, respectively. We enrolled 1,343 patients who underwent laparoscopic surgery for complicated appendicitis between January 2009 and December 2014. At the beginning of the new protocol, the patients were divided into two groups; 10 days of various antibiotic regimens (between January 2009 and June 2012, called the non-standardized protocol; n = 730) and five days of cefuroxime and metronidazole regimen (between July 2012 and December 2014; standardized protocol; n = 613). We compared the clinical outcomes, including surgical site infection (SSI) (superficial and deep organ/space infections) in the two groups. The standardized protocol group had a slightly shorter operative time (67 vs. 69 min), a shorter hospital stay (5 vs. 5.4 d), and lower medical cost (US$1,564 vs. US$1,654). Otherwise, there was no difference between the groups. No differences were found in the non-standardized and standard protocol groups with regard to the rate of superficial infection (10.3% vs. 12.7%; p = 0.488) or deep organ/space infection (2.3% vs. 2.1%; p = 0.797). In patients undergoing laparoscopic surgery for complicated appendicitis, five days of cefuroxime and metronidazole did not lead to more SSIs, and it decreased the medical costs compared with non-standardized antibiotic regimens.

The quest to standardize hemodialysis care.

PubMed

Hegbrant, Jörgen; Gentile, Giorgio; Strippoli, Giovanni F M

2011-01-01

A large global dialysis provider's core activities include providing dialysis care with excellent quality, ensuring a low variability across the clinic network and ensuring strong focus on patient safety. In this article, we summarize the pertinent components of the quality assurance and safety program of the Diaverum Renal Services Group. Concerning medical performance, the key components of a successful quality program are setting treatment targets; implementing evidence-based guidelines and clinical protocols; consistently, regularly, prospectively and accurately collecting data from all clinics in the network; processing collected data to provide feedback to clinics in a timely manner, incorporating information on interclinic and intercountry variations; and revising targets, guidelines and clinical protocols based on sound scientific data. The key activities for ensuring patient safety include a standardized approach to education, i.e. a uniform education program including control of theoretical knowledge and clinical competencies; implementation of clinical policies and procedures in the organization in order to reduce variability and potential defects in clinic practice; and auditing of clinical practice on a regular basis. By applying a standardized and systematic continuous quality improvement approach throughout the entire organization, it has been possible for Diaverum to progressively improve medical performance and ensure patient safety. Copyright © 2011 S. Karger AG, Basel.

Feasibility of Automatic Extraction of Electronic Health Data to Evaluate a Status Epilepticus Clinical Protocol.

PubMed

Hafeez, Baria; Paolicchi, Juliann; Pon, Steven; Howell, Joy D; Grinspan, Zachary M

2016-05-01

Status epilepticus is a common neurologic emergency in children. Pediatric medical centers often develop protocols to standardize care. Widespread adoption of electronic health records by hospitals affords the opportunity for clinicians to rapidly, and electronically evaluate protocol adherence. We reviewed the clinical data of a small sample of 7 children with status epilepticus, in order to (1) qualitatively determine the feasibility of automated data extraction and (2) demonstrate a timeline-style visualization of each patient's first 24 hours of care. Qualitatively, our observations indicate that most clinical data are well labeled in structured fields within the electronic health record, though some important information, particularly electroencephalography (EEG) data, may require manual abstraction. We conclude that a visualization that clarifies a patient's clinical course can be automatically created using the patient's electronic clinical data, supplemented with some manually abstracted data. Future work could use this timeline to evaluate adherence to status epilepticus clinical protocols. © The Author(s) 2015.

Automatic control of pressure support for ventilator weaning in surgical intensive care patients.

PubMed

Schädler, Dirk; Engel, Christoph; Elke, Gunnar; Pulletz, Sven; Haake, Nils; Frerichs, Inéz; Zick, Günther; Scholz, Jens; Weiler, Norbert

2012-03-15

Despite its ability to reduce overall ventilation time, protocol-guided weaning from mechanical ventilation is not routinely used in daily clinical practice. Clinical implementation of weaning protocols could be facilitated by integration of knowledge-based, closed-loop controlled protocols into respirators. To determine whether automated weaning decreases overall ventilation time compared with weaning based on a standardized written protocol in an unselected surgical patient population. In this prospective controlled trial patients ventilated for longer than 9 hours were randomly allocated to receive either weaning with automatic control of pressure support ventilation (automated-weaning group) or weaning based on a standardized written protocol (control group) using the same ventilation mode. The primary end point of the study was overall ventilation time. Overall ventilation time (median [25th and 75th percentile]) did not significantly differ between the automated-weaning (31 [19-101] h; n = 150) and control groups (39 [20-118] h; n = 150; P = 0.178). Patients who underwent cardiac surgery (n = 132) exhibited significantly shorter overall ventilation times in the automated-weaning (24 [18-57] h) than in the control group (35 [20-93] h; P = 0.035). The automated-weaning group exhibited shorter ventilation times until the first spontaneous breathing trial (1 [0-15] vs. 9 [1-51] h; P = 0.001) and a trend toward fewer tracheostomies (17 vs. 28; P = 0.075). Overall ventilation times did not significantly differ between weaning using automatic control of pressure support ventilation and weaning based on a standardized written protocol. Patients after cardiac surgery may benefit from automated weaning. Implementation of additional control variables besides the level of pressure support may further improve automated-weaning systems. Clinical trial registered with www.clinicaltrials.gov (NCT 00445289).

Standardized protocols for quality control of MRM-based plasma proteomic workflows.

PubMed

Percy, Andrew J; Chambers, Andrew G; Smith, Derek S; Borchers, Christoph H

2013-01-04

Mass spectrometry (MS)-based proteomics is rapidly emerging as a viable technology for the identification and quantitation of biological samples, such as human plasma--the most complex yet commonly employed biofluid in clinical analyses. The transition from a qualitative to quantitative science is required if proteomics is going to successfully make the transition to a clinically useful technique. MS, however, has been criticized for a lack of reproducibility and interlaboratory transferability. Currently, the MS and plasma proteomics communities lack standardized protocols and reagents to ensure that high-quality quantitative data can be accurately and precisely reproduced by laboratories across the world using different MS technologies. Toward addressing this issue, we have developed standard protocols for multiple reaction monitoring (MRM)-based assays with customized isotopically labeled internal standards for quality control of the sample preparation workflow and the MS platform in quantitative plasma proteomic analyses. The development of reference standards and their application to a single MS platform is discussed herein, along with the results from intralaboratory tests. The tests highlighted the importance of the reference standards in assessing the efficiency and reproducibility of the entire bottom-up proteomic workflow and revealed errors related to the sample preparation and performance quality and deficits of the MS and LC systems. Such evaluations are necessary if MRM-based quantitative plasma proteomics is to be used in verifying and validating putative disease biomarkers across different research laboratories and eventually in clinical laboratories.

Accuracy of the clinical diagnosis of vaginitis compared with a DNA probe laboratory standard.

PubMed

Lowe, Nancy K; Neal, Jeremy L; Ryan-Wenger, Nancy A

2009-01-01

To estimate the accuracy of the clinical diagnosis of the three most common causes of acute vulvovaginal symptoms (bacterial vaginosis, candidiasis vaginitis, and trichomoniasis vaginalis) using a traditional, standardized clinical diagnostic protocol compared with a DNA probe laboratory standard. This prospective clinical comparative study had a sample of 535 active-duty United States military women presenting with vulvovaginal symptoms. Clinical diagnoses were made by research staff using a standardized protocol of history, physical examination including pelvic examination, determination of vaginal pH, vaginal fluid amines test, and wet-prep microscopy. Vaginal fluid samples were obtained for DNA analysis. The research clinicians were blinded to the DNA results. The participants described a presenting symptom of abnormal discharge (50%), itching/irritation (33%), malodor (10%), burning (4%), or others such as vulvar pain and vaginal discomfort. According to laboratory standard, there were 225 cases (42%) of bacterial vaginosis, 76 cases (14%) of candidiasis vaginitis, 8 cases (1.5%) of trichomoniasis vaginalis, 87 cases of mixed infections (16%), and 139 negative cases (26%). For each single infection, the clinical diagnosis had a sensitivity and specificity of 80.8% and 70.0% for bacterial vaginosis, 83.8% and 84.8% for candidiasis vaginitis, and 84.6% and 99.6% for trichomoniasis vaginalis when compared with the DNA probe standard. Compared with a DNA probe standard, clinical diagnosis is 81-85% sensitive and 70-99% specific for bacterial vaginosis, Candida vaginitis, and trichomoniasis. Even under research conditions that provided clinicians with sufficient time and materials to conduct a thorough and standardized clinical evaluation, the diagnosis and, therefore, subsequent treatment of these common vaginal problems remains difficult. II.

Head Tilt Posturography to Enhance Balance Control Assessment for Astronauts: A Case Study

NASA Technical Reports Server (NTRS)

Hwang, E. Y.; Paloski, W. H.

2006-01-01

For many years, we have used a standard clinical computerized dynamic posturography (CDP) protocol to assess recovery of integrated sensory-motor function in astronauts returning from space flight. The most reliable indications of postflight crew performance capabilities have been obtained from the sensory organization tests (SOTs) within the CDP protocol, particularly SOTs 5 (eyes closed, surface support sway referenced) and 6 (eyes open, surface support and visual surround sway referenced), which are sensitive to changes in availability and/or utilization of vestibular cues. We have observed, however, that some astronauts exhibiting visible signs of incomplete sensory-motor recovery are able to score within clinical norms on standard SOTs 5 and 6 trials, perhaps as a result of cognitive strategies driven by their naturally competitive natures. To improve the sensitivity of the CDP protocol for assessing recovery of integrated sensory-motor function and fitness to return to duties and/or activities of daily living, we have introduced pitch plane head tilt SOT trials to our protocol. In a preliminary study of 5 short duration (11day missions) astronauts, we showed that they were unable to maintain balance on landing day when performing dynamic head tilt trials, despite scoring within the clinically normal range on the standard SOT trials. The present case report illustrates the advantages of including head tilt trials for assessing sensory-motor recovery in long duration crewmembers.

Therapeutic hypothermia for neonatal encephalopathy: JSPNM & MHLW Japan Working Group Practice Guidelines Consensus Statement from the Working Group on Therapeutic Hypothermia for Neonatal Encephalopathy, Ministry of Health, Labor and Welfare (MHLW), Japan, and Japan Society for Perinatal and Neonatal Medicine (JSPNM).

PubMed

Takenouchi, Toshiki; Iwata, Osuke; Nabetani, Makoto; Tamura, Masanori

2012-02-01

Neonatal encephalopathy (NE) secondary to intrapartum asphyxia remains a major cause of post-natal death and permanent neurological deficits worldwide. Supportive therapy has been the mainstay of the treatment until recent series of large clinical trials demonstrating benefit of therapeutic hypothermia (TH) in this high risk population. Now the International Liaison Committee on Resuscitation (ILCOR) recommends TH as a standard of care with the protocols used in the large clinical trials as tentative standard protocols. Our goal is to develop a nationwide consensus practice guideline not only consistent with the international standard protocols but also practical and compatible with the current medical system in Japan. In summary, TH should be offered to newborn infants born ≥36 weeks gestational age and birth weight ≥1800 g exhibiting clinical signs of moderate to severe NE as well as evidence of hypoxia-ischemia, i.e. 10 min Apgar score ≤5, a need for resuscitation at 10 min, blood pH<7.00, or base deficit ≥16 mmol/L. TH should be conducted in the NICUs capable of multidisciplinary care and under the standard protocols, i.e. utilization of cooling device, target (rectal or esophageal) temperatures at 33.5±0.5 and 34.5±0.5°C for whole body and selective head cooling respectively, duration of TH for 72 h, gradual rewarming not exceeding the rate of 0.5°C/h. Long term follow-up with multidisciplinary approach including standardized psychological assessment is warranted. Copyright © 2011 The Japanese Society of Child Neurology. Published by Elsevier B.V. All rights reserved.

Technical standards and guidelines: prenatal screening for Down syndrome that includes first-trimester biochemistry and/or ultrasound measurements.

PubMed

Palomaki, Glenn E; Lee, Jo Ellen S; Canick, Jacob A; McDowell, Geraldine A; Donnenfeld, Alan E

2009-09-01

This statement is intended to augment the current general ACMG Standards and Guidelines for Clinical Genetics Laboratories and to address guidelines specific to first-trimester screening for Down syndrome. The aim is to provide the laboratory the necessary information to ensure accurate and reliable Down syndrome screening results given a screening protocol (e.g., combined first trimester and integrated testing). Information about various test combinations and their expected performance are provided, but other issues such as availability of reagents, patient interest in early test results, access to open neural tube defect screening, and availability of chorionic villus sampling are all contextual factors in deciding which screening protocol(s) will be selected by individual health care providers. Individual laboratories are responsible for meeting the quality assurance standards described by the Clinical Laboratory Improvement Act, the College of American Pathologists, and other regulatory agencies, with respect to appropriate sample documentation, assay validation, general proficiency, and quality control measures. These guidelines address first-trimester screening that includes ultrasound measurement and interpretation of nuchal translucency thickness and protocols that combine markers from both the first and second trimesters. Laboratories can use their professional judgment to make modification or additions.

A Standardized Protocol for the Prospective Follow-Up of Cleft Lip and Palate Patients.

PubMed

Salimi, Negar; Jolanta, Aleksejūnienė; Edwin, Yen; Angelina, Loo

2018-01-01

To develop a standardized all-encompassing protocol for the assessment of cleft lip and palate patients with clinical and research implications. Electronic database searches were conducted and 13 major cleft centers worldwide were contacted in order to prepare for the development of the protocol. In preparation, the available evidence was reviewed and potential fistula-related risk determinants from 4 different domains were identified. No standardized protocol for the assessment of cleft patients could be found in any of the electronic database searches that were conducted. Interviews with representatives from several major centers revealed that the majority of centers do not have a standardized comprehensive strategy for the reporting and follow-up of cleft lip and palate patients. The protocol was developed and consisted of the following domains of determinants: (1) the sociodemographic domain, (2) the cleft defect domain, (3) the surgery domain, and (4) the fistula domain. The proposed protocol has the potential to enhance the quality of patient care by ensuring that multiple patient-related aspects are consistently reported. It may also facilitate future multicenter research, which could contribute to the reduction of fistula occurrence in cleft lip and palate patients.

Standardized terminology for clinical trial protocols based on top-level ontological categories.

PubMed

Heller, B; Herre, H; Lippoldt, K; Loeffler, M

2004-01-01

This paper describes a new method for the ontologically based standardization of concepts with regard to the quality assurance of clinical trial protocols. We developed a data dictionary for medical and trial-specific terms in which concepts and relations are defined context-dependently. The data dictionary is provided to different medical research networks by means of the software tool Onto-Builder via the internet. The data dictionary is based on domain-specific ontologies and the top-level ontology of GOL. The concepts and relations described in the data dictionary are represented in natural language, semi-formally or formally according to their use.

Variation in standards of research compensation and child assent practices: a comparison of 69 institutional review board-approved informed permission and assent forms for 3 multicenter pediatric clinical trials.

PubMed

Kimberly, Michael B; Hoehn, K Sarah; Feudtner, Chris; Nelson, Robert M; Schreiner, Mark

2006-05-01

To systematically compare standards for compensation and child participant assent in informed permission, assent, and consent forms (IP-A-CFs) approved by 55 local institutional review boards (IRBs) reviewing 3 standardized multicenter research protocols. Sixty-nine principal investigators participating in any of 3 national, multicenter clinical trials submitted standardized research protocols for their trials to their local IRBs for approval. Copies of the subsequently IRB-approved IP-A-CFs were then forwarded to an academic clinical research organization. This collection of IRB-approved forms allowed for a quasiexperimental retrospective evaluation of the variation in informed permission, assent, and consent standards operationalized by the local IRBs. Standards for compensation and child participant assent varied substantially across 69 IRB-approved IP-A-CFs. Among the 48 IP-A-CFs offering compensation, monetary compensation was offered by 33 as reimbursement for travel, parking, or food expenses, whereas monetary or material compensation was offered by 22 for subject inconvenience and by 13 for subject time. Compensation ranged widely within and across studies (study 1, $180-1425; study 2, $0-500; and study 3, $0-100). Regarding child participant assent, among the 57 IP-A-CFs that included a form of assent documentation, 33 included a line for assent on the informed permission or consent form, whereas 35 included a separate form written in simplified language. Of the IP-A-CFs that stipulated the documentation of assent, 31 specified > or =1 age ranges for obtaining assent. Informed permission or consent forms were addressed either to parents or child participants. In response to identical clinical trial protocols, local IRBs generate IP-A-CFs that vary considerably regarding compensation and child participant assent.

Assessing the detection, reporting and investigation of adverse events in clinical trial protocols implemented in Cameroon: a documentary review of clinical trial protocols.

PubMed

Ebile, Akoh Walter; Ateudjieu, Jerome; Yakum, Martin Ndinakie; Djuidje, Marceline Ngounoue; Watcho, Pierre

2015-09-29

International guidelines recommend ethical and scientific quality standards for managing and reporting adverse events occurring during clinical trials to competent research ethics committees and regulatory authorities. The purpose of this study was to determine whether clinical trial protocols in Cameroon are developed in line with national requirements and international guidelines as far as detecting, reporting and investigating of adverse events is concerned. It was a documentary review of all approved clinical trial protocols that were submitted at the Cameroon National Ethics Committee for evaluation from 1997 through 2012. Data were extracted using a preconceived and validated grid. Protocol review process targeted the title, abstract, objectives, methodology, resources, and the chapter on safety. In total, 106 (4.9 %) clinical trial protocols were identified from 2173 protocols seen in the archive and 104 (4.8 %) included for review. Seventy six (73.1 %) trials did not include the surveillance of adverse events as part of their objective. A total of 91 (87.5 %) protocols did not budget for adverse event surveillance, 76 (73.1 %) did not have a data safety management board (DSMB), 11(10.6 %) included insurance for participants, 47 (45.2 %) did not include a case definition for serious adverse events, 33 (31.7 %) described procedures to detect adverse events, 33 (31.7 %) described procedure for reporting and 22 (21.2 %) described procedure for investigating adverse events. Most clinical trial protocols in Cameroon are developed to focus on benefits and pay little attention to harms. The development of national guidelines can improve the surveillance of adverse events in clinical trial research conducted in Cameroon. Adverse events surveillance tools and a budget are critical for an adequate planning for adverse event surveillance when developing trial protocols. Clinical trial protocols submitted in the Cameroon National Ethics Committee do not adequately plan to assess adverse events in clinical trial protocols. In order to improve on the safety of participants and marketed drug, there is a need to develop national guidelines for clinical trials by the government, and to improve evaluation procedures and monitoring of ongoing trials by the ethics committee.

[Experts consensus of dental esthetic photography].

PubMed

2017-05-09

Clinical photography in esthetic dentistry is an essential skill in clinical practice. It is widely applied clinically in multiple fields related to esthetic dentistry. Society of Esthetic Dentistry of Chinese Stomatological Association established a consensus for clinical photography and standards for images in esthetic dentistry in order to standardize domestic dental practitioners' procedure, and meet the demands of diagnosis and design in modern esthetic dentistry. It was also developed to facilitate domestic and international academic communication. Sixteen commonly used images in practice, which are of apparent importance in guiding esthetic analysis, design and implementation, are proposed in the standards. This consensus states the clinical significance of these images and the standard protocol of acquiring them.

A universal standard for the validation of blood pressure measuring devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

PubMed

Stergiou, George S; Alpert, Bruce; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, Gerhard; Friedman, Bruce; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P; Lacy, Peter; McManus, Richard; Murray, Alan; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Jiguang; Wu, Colin O; O'Brien, Eoin

2018-03-01

: In the last 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring and the International Organization for Standardization (ISO) have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers and manufacturers would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by AAMI, ESH and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols.

A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement.

PubMed

Stergiou, George S; Alpert, Bruce; Mieke, Stephan; Asmar, Roland; Atkins, Neil; Eckert, Siegfried; Frick, Gerhard; Friedman, Bruce; Graßl, Thomas; Ichikawa, Tsutomu; Ioannidis, John P; Lacy, Peter; McManus, Richard; Murray, Alan; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Quinn, David; Sarkis, Josh; Shennan, Andrew; Usuda, Takashi; Wang, Jiguang; Wu, Colin O; O'Brien, Eoin

2018-03-01

In the past 30 years, several organizations, such as the US Association for the Advancement of Medical Instrumentation (AAMI), the British Hypertension Society, the European Society of Hypertension (ESH) Working Group on Blood Pressure (BP) Monitoring, and the International Organization for Standardization (ISO), have developed protocols for clinical validation of BP measuring devices. However, it is recognized that science, as well as patients, consumers, and manufacturers, would be best served if all BP measuring devices were assessed for accuracy according to an agreed single validation protocol that had global acceptance. Therefore, an international initiative was taken by the AAMI, ESH, and ISO experts who agreed to develop a universal standard for device validation. This statement presents the key aspects of a validation procedure, which were agreed by the AAMI, ESH, and ISO representatives as the basis for a single universal validation protocol. As soon as the AAMI/ESH/ISO standard is fully developed, this will be regarded as the single universal standard and will replace all other previous standards/protocols. © 2018 American Heart Association, Inc., and Wolters Kluwer Health, Inc.

Does the Concept of the “Flipped Classroom” Extend to the Emergency Medicine Clinical Clerkship?

PubMed Central

Heitz, Corey; Prusakowski, Melanie; Willis, George; Franck, Christopher

2015-01-01

Introduction Linking educational objectives and clinical learning during clerkships can be difficult. Clinical shifts during emergency medicine (EM) clerkships provide a wide variety of experiences, some of which may not be relevant to recommended educational objectives. Students can be directed to standardize their clinical experiences, and this improves performance on examinations. We hypothesized that applying a “flipped classroom” model to the clinical clerkship would improve performance on multiple-choice testing when compared to standard learning. Methods Students at two institutions were randomized to complete two of four selected EM clerkship topics in a “flipped fashion,” and two others in a standard fashion. For flipped topics, students were directed to complete chief complaint-based asynchronous modules prior to a shift, during which they were directed to focus on the chief complaint. For the other two topics, modules were to be performed at the students’ discretion, and shifts would not have a theme. At the end of the four-week clerkship, a 40-question multiple-choice examination was administered with 10 questions per topic. We compared performance on flipped topics with those performed in standard fashion. Students were surveyed on perceived effectiveness, ability to follow the protocol, and willingness of preceptors to allow a chief-complaint focus. Results Sixty-nine students participated; examination scores for 56 were available for analysis. For the primary outcome, no difference was seen between the flipped method and standard (p=0.494.) A mixed model approach showed no effect of flipped status, protocol adherence, or site of rotation on the primary outcome of exam scores. Students rated the concept of the flipped clerkship highly (3.48/5). Almost one third (31.1%) of students stated that they were unable to adhere to the protocol. Conclusion Preparation for a clinical shift with pre-assigned, web-based learning modules followed by an attempt at chief-complaint-focused learning during a shift did not result in improvements in performance on a multiple-choice assessment of knowledge; however, one third of participants did not adhere strictly to the protocol. Future investigations should ensure performance of pre-assigned learning as well as clinical experiences, and consider alternate measures of knowledge. PMID:26594277

Verification and large scale clinical evaluation of a national standard protocol for Salmonella spp./Shigella spp. screening using real-time PCR combined with guided culture.

PubMed

Tang, Xi-Jun; Yang, Ze; Chen, Xin-Bin; Tian, Wen-Fang; Tu, Cheng-Ning; Wang, Hai-Bo

2018-02-01

Salmonella spp./Shigella spp. are often associated with food poisoning and fecal-oral transmission of acute gastroenteritis that requires strict monitoring, especially among people who would handle food and water. In 2014, the National Health and Family Planning Commission of the P. R. China issued a national standard protocol (recommendatory) for the screening of Salmonella spp./Shigella spp.. However, its performance has not been fully studied. Whether it was suitable for use in our laboratory was still unknown. In the current study, the new protocol was first verified by various experiments and then its clinical performance was evaluated in about 20,000 stool samples over a three-year period. Verification results showed that the new protocol was highly specific and reproducible. Sensitivity (as defined as the lower limit of detection) of the new protocol at the PCR step was 10 3 CFU/mL and 10 1 CFU/mL for Salmonella spp. and Shigella spp., while that at the guided culture step was 10 4 CFU/mL and 10 3 CFU/mL, respectively. The large scale clinical evaluation indicated that the new protocol could increase the positivity rate by two fold and decrease the workload/median turnaround time significantly. In conclusion, the protocol was verified and evaluated and was proven to be a valuable platform for the rapid, specific, sensitive and high-throughput screening of Salmonella spp./Shigella spp. Copyright © 2017 Elsevier B.V. All rights reserved.

A diabetes-specific enteral formula improves glycemic variability in patients with type 2 diabetes.

PubMed

Alish, Carolyn J; Garvey, W Timothy; Maki, Kevin C; Sacks, Gordon S; Hustead, Deborah S; Hegazi, Refaat A; Mustad, Vikkie A

2010-06-01

Well-controlled studies have demonstrated that inpatient hyperglycemia is an indicator of poor clinical outcomes, but the use of diabetes-specific enteral formulas in hospitalized patients remains a topic of great debate. In two different protocols, postprandial glycemia and insulinemia were measured in 22 subjects with diabetes fed a diabetes-specific or standard formula (protocol 1). Continuous glucose monitoring was used to assess glucose levels in 12 enterally fed patients with diabetes receiving the standard formula followed by the diabetes-specific formula continuously for 5 days each (protocol 2). End points included postprandial glycemia and insulinemia, glycemic variability (mean amplitude of glycemic excursions [MAGE]), mean glucose, and insulin use. In the postprandial response protocol, the diabetes-specific formula resulted in lower positive areas under the postprandial curve (P < 0.001) and peak glucose (P < 0.001) and insulin (P = 0.017) levels. In the protocol using continuous glucose monitoring, glycemic variability (as measured by MAGE) was lower with continuous administration of the diabetes-specific than the standard formula (64.6 +/- 6.8 mg/dL vs. 110.6 +/-15.3 mg/dL, P = 0.003). Also, administration of the diabetes-specific formula resulted in lower mean glucose concentrations during feeding (171.1 +/- 16.1 vs. 202.1 +/- 17.4 mg/dL, P = 0.024) and insulin requirements (7.8 +/- 2.3 vs. 10.9 +/- 3.3 units/day, P = 0.039) than the standard formula. Relative to the standard formula, the diabetes-specific formula reduced postprandial glycemia, mean glucose, glycemic variability, and short-acting insulin requirements. These results suggest potential clinical usefulness of a diabetes-specific enteral formula for minimizing glycemic excursions in hospitalized patients.

The Clinical Urine Culture: Enhanced Techniques Improve Detection of Clinically Relevant Microorganisms

PubMed Central

Price, Travis K.; Dune, Tanaka; Hilt, Evann E.; Thomas-White, Krystal J.; Kliethermes, Stephanie; Brincat, Cynthia; Brubaker, Linda; Wolfe, Alan J.

2016-01-01

Enhanced quantitative urine culture (EQUC) detects live microorganisms in the vast majority of urine specimens reported as “no growth” by the standard urine culture protocol. Here, we evaluated an expanded set of EQUC conditions (expanded-spectrum EQUC) to identify an optimal version that provides a more complete description of uropathogens in women experiencing urinary tract infection (UTI)-like symptoms. One hundred fifty adult urogynecology patient-participants were characterized using a self-completed validated UTI symptom assessment (UTISA) questionnaire and asked “Do you feel you have a UTI?” Women responding negatively were recruited into the no-UTI cohort, while women responding affirmatively were recruited into the UTI cohort; the latter cohort was reassessed with the UTISA questionnaire 3 to 7 days later. Baseline catheterized urine samples were plated using both standard urine culture and expanded-spectrum EQUC protocols: standard urine culture inoculated at 1 μl onto 2 agars incubated aerobically; expanded-spectrum EQUC inoculated at three different volumes of urine onto 7 combinations of agars and environments. Compared to expanded-spectrum EQUC, standard urine culture missed 67% of uropathogens overall and 50% in participants with severe urinary symptoms. Thirty-six percent of participants with missed uropathogens reported no symptom resolution after treatment by standard urine culture results. Optimal detection of uropathogens could be achieved using the following: 100 μl of urine plated onto blood (blood agar plate [BAP]), colistin-nalidixic acid (CNA), and MacConkey agars in 5% CO2 for 48 h. This streamlined EQUC protocol achieved 84% uropathogen detection relative to 33% detection by standard urine culture. The streamlined EQUC protocol improves detection of uropathogens that are likely relevant for symptomatic women, giving clinicians the opportunity to receive additional information not currently reported using standard urine culture techniques. PMID:26962083

Development of an alcohol withdrawal protocol: CNS collaborative exemplar.

PubMed

Phillips, Susan; Haycock, Camille; Boyle, Deborah

2006-01-01

The purpose of this process improvement project was to develop an Alcohol Withdrawal Syndrome (AWS) management protocol for acute care. The prevalence of alcohol abuse in our society presents challenges for health professionals, and few nurses have received formal education on the identification and treatment of AWS, which has frequently resulted in ineffective, nonstandardized care. However, nurses practicing in medical-surgical, emergency, trauma, and critical care settings must be astute in the assessment and management of AWS. DESIGN/BACKGROUND/RATIONALE: Following an analysis of existing management protocols, a behavioral health clinical nurse specialist was asked to lead a work team composed of physicians, pharmacists, and nurses to develop a new evidence-based alcohol withdrawal protocol for acute care. By implementing a standardized assessment tool and treatment protocol, clinical nurse specialists empowered nursing staff with strategies to prevent the serious medical complications associated with AWS. FINDINGS/OUTCOMES: The development and integration of a safe and effective treatment protocol to manage AWS was facilitated by collaborative, evidence-based decision making. Clinical experience and specialty expertise were integrated by clinical nurse specialists skilled in group dynamics, problem-solving, and the implementation of change. Improving care of patients in AWS is an exemplar for clinical nurse specialist roles as change agent and patient advocate.

Variation in radiographic protocols in paediatric interventional cardiology.

PubMed

McFadden, S L; Hughes, C M; Winder, R J

2013-06-01

The aim of this work is to determine current radiographic protocols in paediatric interventional cardiology (IC) in the UK and Ireland. To do this we investigated which imaging parameters/protocols are commonly used in IC in different hospitals, to identify if a standard technique is used and illustrate any variation in practice. A questionnaire was sent to all hospitals in the UK and Ireland which perform paediatric IC to obtain information on techniques used in each clinical department and on the range of clinical examinations performed. Ethical and research governance approval was sought from the Office for Research Ethics Committees Northern Ireland and the individual trusts. A response rate of 79% was achieved, and a wide variation in technique was found between hospitals. The main differences in technique involved variations in the use of an anti-scatter grid and the use of additional filtration to the radiation beam, frame rates for digital acquisition and pre-programmed projections/paediatric specific programming in the equipment. We conclude that there is no standard protocol for carrying out paediatric IC in the UK or Ireland. Each hospital carries out the IC procedure according to its own local protocols resulting in a wide variation in radiation dose.

Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature.

PubMed

Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

2016-01-01

Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or "frosties," show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50-85%). We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol.

Standardisation of neonatal clinical practice.

PubMed

Bhutta, Z A; Giuliani, F; Haroon, A; Knight, H E; Albernaz, E; Batra, M; Bhat, B; Bertino, E; McCormick, K; Ochieng, R; Rajan, V; Ruyan, P; Cheikh Ismail, L; Paul, V

2013-09-01

The International Fetal and Newborn Growth Consortium for the 21(st) Century (INTERGROWTH-21(st) ) is a large-scale, population-based, multicentre project involving health institutions from eight geographically diverse countries, which aims to assess fetal, newborn and preterm growth under optimal conditions. Given the multicentre nature of the project and the expected number of preterm births, it is vital that all centres follow the same standardised clinical care protocols to assess and manage preterm infants, so as to ensure maximum validity of the resulting standards as indicators of growth and nutrition with minimal confounding. Moreover, it is well known that evidence-based clinical practice guidelines can reduce the delivery of inappropriate care and support the introduction of new knowledge into clinical practice. The INTERGROWTH-21(st) Neonatal Group produced an operations manual, which reflects the consensus reached by members of the group regarding standardised definitions of neonatal morbidities and the minimum standards of care to be provided by all centres taking part in the project. The operational definitions and summary management protocols were developed by consensus through a Delphi process based on systematic reviews of relevant guidelines and management protocols by authoritative bodies. This paper describes the process of developing the Basic Neonatal Care Manual, as well as the morbidity definitions and standardised neonatal care protocols applied across all the INTERGROWTH-21(st) participating centres. Finally, thoughts about implementation strategies are presented. © 2013 Royal College of Obstetricians and Gynaecologists.

Prospective Evaluation of a Matrix-Assisted Laser Desorption Ionization–Time of Flight Mass Spectrometry System in a Hospital Clinical Microbiology Laboratory for Identification of Bacteria and Yeasts: a Bench-by-Bench Study for Assessing the Impact on Time to Identification and Cost-Effectiveness

PubMed Central

Tan, K. E.; Ellis, B. C.; Lee, R.; Stamper, P. D.; Zhang, S. X.

2012-01-01

Matrix-assisted laser desorption ionization–time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories. PMID:22855510

Prospective evaluation of a matrix-assisted laser desorption ionization-time of flight mass spectrometry system in a hospital clinical microbiology laboratory for identification of bacteria and yeasts: a bench-by-bench study for assessing the impact on time to identification and cost-effectiveness.

PubMed

Tan, K E; Ellis, B C; Lee, R; Stamper, P D; Zhang, S X; Carroll, K C

2012-10-01

Matrix-assisted laser desorption ionization-time of flight mass spectrometry (MALDI-TOF MS) has been found to be an accurate, rapid, and inexpensive method for the identification of bacteria and yeasts. Previous evaluations have compared the accuracy, time to identification, and costs of the MALDI-TOF MS method against standard identification systems or commercial panels. In this prospective study, we compared a protocol incorporating MALDI-TOF MS (MALDI protocol) with the current standard identification protocols (standard protocol) to determine the performance in actual practice using a specimen-based, bench-by-bench approach. The potential impact on time to identification (TTI) and costs had MALDI-TOF MS been the first-line identification method was quantitated. The MALDI protocol includes supplementary tests, notably for Streptococcus pneumoniae and Shigella, and indications for repeat MALDI-TOF MS attempts, often not measured in previous studies. A total of 952 isolates (824 bacterial isolates and 128 yeast isolates) recovered from 2,214 specimens were assessed using the MALDI protocol. Compared with standard protocols, the MALDI protocol provided identifications 1.45 days earlier on average (P < 0.001). In our laboratory, we anticipate that the incorporation of the MALDI protocol can reduce reagent and labor costs of identification by $102,424 or 56.9% within 12 months. The model included the fixed annual costs of the MALDI-TOF MS, such as the cost of protein standards and instrument maintenance, and the annual prevalence of organisms encountered in our laboratory. This comprehensive cost analysis model can be generalized to other moderate- to high-volume laboratories.

[Fewer caesarean sections for breech presentation following external cephalic version according to a protocol in a special office visit].

PubMed

Kuppens, S M I; Hasaart, T H M; van der Donk, M W P; Huibers, M; Franssen, M J; de Becker, B M J; Wijnen, H A A; Pop, V J M

2008-06-07

Identification of determinants affecting the outcome of external cephalic version (ECV) in breech presentation, and investigation of the impact of ECV--performed according to a standardized protocol in an outpatient clinic--on the mode of delivery. Retrospective analysis. In 2003 a standardized protocol of ECV was developed in the outpatient clinic for obstetrics of the Catharina Hospital in Eindhoven, the Netherlands; it was tested in 'version office visits'. Obstetric characteristics of all pregnant women who underwent attempts of ECV in the clinic from January 2004 until June 2006 during these sessions, and the subsequent births, were analysed. 85% of all ECVs were performed by the same hospital midwife and gynaecologist, in accordance with the protocol. ECV was successful in 96 of 209 pregnant women (46%). In 1 pregnant woman an emergency caesarean section was performed after ECV because of partial abruptio placentae. Nulliparity, incomplete breech presentation and low birth weight of the baby were associated with a lower success rate of ECV in this study. In the group with a successful ECV the percentage of caesarean deliveries was substantially lower (9 versus 83%; odds ratio: 0.21; 95% CI: 0.09-0.51). A regular team consisting of a hospital midwife and a gynaecologist working according to a standardized protocol for ECV in a case of breech presentation proved successful: the number of term breech presentations substantially diminished and therefore the percentage of caesarean sections was lower in the group in which ECV had been successful. This could have considerable impact on health care in the Netherlands in terms of reduced maternal morbidity and cost savings.

Titrating Oxygen Requirements During Exercise: Evaluation of a Standardized Single Walk Test Protocol.

PubMed

Giovacchini, Coral X; Mathews, Anne M; Lawlor, Brian R; MacIntyre, Neil R

2018-04-01

Oxygen supplementation for exercise-induced hypoxemia is a common clinical practice that improves exercise tolerance. However, we know of no standardized exercise oxygen titration protocol using a single walk test. We report our experience with a protocol developed in our laboratory. Our protocol is based on the 6-min walk test (6MWT). Pulse oximetry readings (oxygen saturation [Spo 2 ]) are monitored, and supplemental oxygen is added in 2 L/min increments to keep Spo 2 > 88%. This continues for at least 6 min of walking with the Spo 2 remaining > 88% for at least 3 min. The records of consecutive patients over 4 months undergoing this procedure were reviewed for test performance, oxygen titration results, and adverse events. Two hundred twenty-two patients were tested; only two prematurely terminated the protocol because of intractable dyspnea. One hundred fifty-six patients (38%) required oxygen supplementation, with the first titration most commonly occurring between 1 and 2 min of walking. Nine of the patients had the first titration after 5 min of walking. The average test duration was 7 min (maximum, 15 min). The average number of titrations was 2.2 (maximum six). Sixteen patients could not maintain Spo 2 > 88% for 3 min despite administration of 15 L/min of supplemental oxygen (maximal dose). Our protocol was easily performed as a modification of a standard 6MWT with no serious adverse events. Because it is based on a widely accepted measurement of functional capabilities, and because it determined a stable final oxygen dose for ≥ 3 min of walking in most patients, we believe this protocol can be easily adapted for clinical use. Copyright © 2017 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.

A randomized trial of protocol-based care for early septic shock.

PubMed

Yealy, Donald M; Kellum, John A; Huang, David T; Barnato, Amber E; Weissfeld, Lisa A; Pike, Francis; Terndrup, Thomas; Wang, Henry E; Hou, Peter C; LoVecchio, Frank; Filbin, Michael R; Shapiro, Nathan I; Angus, Derek C

2014-05-01

In a single-center study published more than a decade ago involving patients presenting to the emergency department with severe sepsis and septic shock, mortality was markedly lower among those who were treated according to a 6-hour protocol of early goal-directed therapy (EGDT), in which intravenous fluids, vasopressors, inotropes, and blood transfusions were adjusted to reach central hemodynamic targets, than among those receiving usual care. We conducted a trial to determine whether these findings were generalizable and whether all aspects of the protocol were necessary. In 31 emergency departments in the United States, we randomly assigned patients with septic shock to one of three groups for 6 hours of resuscitation: protocol-based EGDT; protocol-based standard therapy that did not require the placement of a central venous catheter, administration of inotropes, or blood transfusions; or usual care. The primary end point was 60-day in-hospital mortality. We tested sequentially whether protocol-based care (EGDT and standard-therapy groups combined) was superior to usual care and whether protocol-based EGDT was superior to protocol-based standard therapy. Secondary outcomes included longer-term mortality and the need for organ support. We enrolled 1341 patients, of whom 439 were randomly assigned to protocol-based EGDT, 446 to protocol-based standard therapy, and 456 to usual care. Resuscitation strategies differed significantly with respect to the monitoring of central venous pressure and oxygen and the use of intravenous fluids, vasopressors, inotropes, and blood transfusions. By 60 days, there were 92 deaths in the protocol-based EGDT group (21.0%), 81 in the protocol-based standard-therapy group (18.2%), and 86 in the usual-care group (18.9%) (relative risk with protocol-based therapy vs. usual care, 1.04; 95% confidence interval [CI], 0.82 to 1.31; P=0.83; relative risk with protocol-based EGDT vs. protocol-based standard therapy, 1.15; 95% CI, 0.88 to 1.51; P=0.31). There were no significant differences in 90-day mortality, 1-year mortality, or the need for organ support. In a multicenter trial conducted in the tertiary care setting, protocol-based resuscitation of patients in whom septic shock was diagnosed in the emergency department did not improve outcomes. (Funded by the National Institute of General Medical Sciences; ProCESS ClinicalTrials.gov number, NCT00510835.).

High-Level Disinfection of Otorhinolaryngology Clinical Instruments: An Evaluation of the Efficacy and Cost-effectiveness of Instrument Storage.

PubMed

Yalamanchi, Pratyusha; Yu, Jason; Chandler, Laura; Mirza, Natasha

2018-01-01

Objectives Despite increasing interest in individual instrument storage, risk of bacterial cross-contamination of otorhinolaryngology clinic instruments has not been assessed. This study is the first to determine the clinical efficacy and cost-effectiveness of standard high-level disinfection and clinic instrument storage. Methods To assess for cross-contamination, surveillance cultures of otorhinolaryngology clinic instruments subject to standard high-level disinfection and storage were obtained at the start and end of the outpatient clinical workday. Rate of microorganism recovery was compared with cultures of instruments stored in individual peel packs and control cultures of contaminated instruments. Based on historical clinic data, the direct allocation method of cost accounting was used to determine aggregate raw material cost and additional labor hours required to process and restock peel-packed instruments. Results Among 150 cultures of standard high-level disinfected and co-located clinic instruments, 3 positive bacterial cultures occurred; 100% of control cultures were positive for bacterial species ( P < .001). There was no statistical difference between surveillance cultures obtained before and after the clinic day. While there was also no significant difference in rate of contamination between peel-packed and co-located instruments, peel packing all instruments requires 6250 additional labor hours, and conservative analyses place the cost of individual semicritical instrument storage at $97,852.50 per year. Discussion With in vitro inoculation of >200 otorhinolaryngology clinic instruments, this study demonstrates that standard high-level disinfection and storage are equally efficacious to more time-consuming and expensive individual instrument storage protocols, such as peel packing, with regard to bacterial contamination. Implications for Practice Standard high-level disinfection and storage are equally effective to labor-intensive and costly individual instrument storage protocols.

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care

PubMed Central

Kraybill, Ashley; Dember, Laura M.; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S.; Madden, Vanessa; Halpern, Scott D.

2016-01-01

Background Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. Methods We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. Results A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients’ concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. Conclusions This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials. PMID:27833931

Patient and Physician Views about Protocolized Dialysis Treatment in Randomized Trials and Clinical Care.

PubMed

Kraybill, Ashley; Dember, Laura M; Joffe, Steven; Karlawish, Jason; Ellenberg, Susan S; Madden, Vanessa; Halpern, Scott D

2016-01-01

Pragmatic trials comparing standard-of-care interventions may improve the quality of care for future patients, but raise ethical questions about limitations on decisional autonomy. We sought to understand how patients and physicians view and respond to these questions in the contexts of pragmatic trials and of usual clinical care. We conducted scenario-based, semi-structured interviews with 32 patients with end-stage renal disease (ESRD) receiving maintenance hemodialysis in outpatient dialysis units and with 24 nephrologists. Each participant was presented with two hypothetical scenarios in which a protocolized approach to hemodialysis treatment time was adopted for the entire dialysis unit as part of a clinical trial or a new clinical practice. A modified grounded theory analysis revealed three major themes: 1) the value of research, 2) the effect of protocolized care on patient and physician autonomy, and 3) information exchange between patients and physicians, including the mechanism of consent. Most patients and physicians were willing to relinquish decisional autonomy and were more willing to relinquish autonomy for research purposes than in clinical care. Patients' concerns towards clinical trials were tempered by their desires for certainty for a positive outcome and for physician validation. Patients tended to believe that being informed about research was more important than the actual mechanism of consent, and most were content with being able to opt out from participating. This qualitative study suggests the general acceptability of a pragmatic clinical trial comparing standard-of-care interventions that limits decisional autonomy for nephrologists and patients receiving hemodialysis. Future studies are needed to determine whether similar findings would emerge among other patients and providers considering other standard-of-care trials.

Optimisation of pharmacy content in clinical cancer research protocols: Experience of the United Kingdom Chemotherapy and Pharmacy Advisory Service.

PubMed

Debruyne, Philip R; Johnson, Philip J; Pottel, Lies; Daniels, Susanna; Greer, Rachel; Hodgkinson, Elizabeth; Kelly, Stephen; Lycke, Michelle; Samol, Jens; Mason, Julie; Kimber, Donna; Loucaides, Eileen; Parmar, Mahesh Kb; Harvey, Sally

2015-06-01

Clarity and accuracy of the pharmacy aspects of cancer clinical trial protocols is essential. Inconsistencies and ambiguities in such protocols have the potential to delay research and jeopardise both patient safety and collection of credible data. The Chemotherapy and Pharmacy Advisory Service was established by the UK National Cancer Research Network, currently known as National Institute for Health Research Clinical Research Network, to improve the quality of pharmacy-related content in cancer clinical research protocols. This article reports the scope of Chemotherapy and Pharmacy Advisory Service, its methodology of mandated protocol review and pharmacy-related guidance initiatives and its current impact. Over a 6-year period (2008-2013) since the inception of Chemotherapy and Pharmacy Advisory Service, cancer clinical trial protocols were reviewed by the service, prior to implementation at clinical trial sites. A customised Review Checklist was developed and used by a panel of experts to standardise the review process and report back queries and inconsistencies to chief investigators. Based on common queries, a Standard Protocol Template comprising specific guidance on drug-related content and a Pharmacy Manual Template were developed. In addition, a guidance framework was established to address 'ad hoc' pharmacy-related queries. The most common remarks made at protocol review have been summarised and categorised through retrospective analysis. In order to evaluate the impact of the service, chief investigators were asked to respond to queries made at protocol review and make appropriate changes to their protocols. Responses from chief investigators have been collated and acceptance rates determined. A total of 176 protocols were reviewed. The median number of remarks per protocol was 26, of which 20 were deemed clinically relevant and mainly concerned the drug regimen, support medication, frequency and type of monitoring and drug supply aspects. Further analysis revealed that 62% of chief investigators responded to the review. All responses were positive with an overall acceptance rate of 89% of the proposed protocol changes. Review of pharmacy content of cancer clinical trial protocols is feasible and exposes many undetected clinically relevant issues that could hinder efficient trial conduct. Our service audit revealed that the majority of suggestions were effectively incorporated in the final protocols. The refinement of existing and development of new pharmacy-related guidance documents by Chemotherapy and Pharmacy Advisory Service might aid in better and safer clinical research. © The Author(s) 2015.

Remotely-supervised transcranial direct current stimulation (tDCS) for clinical trials: guidelines for technology and protocols.

PubMed

Charvet, Leigh E; Kasschau, Margaret; Datta, Abhishek; Knotkova, Helena; Stevens, Michael C; Alonzo, Angelo; Loo, Colleen; Krull, Kevin R; Bikson, Marom

2015-01-01

The effect of transcranial direct current stimulation (tDCS) is cumulative. Treatment protocols typically require multiple consecutive sessions spanning weeks or months. However, traveling to clinic for a tDCS session can present an obstacle to subjects and their caregivers. With modified devices and headgear, tDCS treatment can be administered remotely under clinical supervision, potentially enhancing recruitment, throughput, and convenience. Here we propose standards and protocols for clinical trials utilizing remotely-supervised tDCS with the goal of providing safe, reproducible and well-tolerated stimulation therapy outside of the clinic. The recommendations include: (1) training of staff in tDCS treatment and supervision; (2) assessment of the user's capability to participate in tDCS remotely; (3) ongoing training procedures and materials including assessments of the user and/or caregiver; (4) simple and fail-safe electrode preparation techniques and tDCS headgear; (5) strict dose control for each session; (6) ongoing monitoring to quantify compliance (device preparation, electrode saturation/placement, stimulation protocol), with corresponding corrective steps as required; (7) monitoring for treatment-emergent adverse effects; (8) guidelines for discontinuation of a session and/or study participation including emergency failsafe procedures tailored to the treatment population's level of need. These guidelines are intended to provide a minimal level of methodological rigor for clinical trials seeking to apply tDCS outside a specialized treatment center. We outline indication-specific applications (Attention Deficit Hyperactivity Disorder, Depression, Multiple Sclerosis, Palliative Care) following these recommendations that support a standardized framework for evaluating the tolerability and reproducibility of remote-supervised tDCS that, once established, will allow for translation of tDCS clinical trials to a greater size and range of patient populations.

Potential contributions of hypnosis to ego-strengthening procedures in EMDR. Eye Movement Desensitization Reprocessing.

PubMed

Phillips, M

2001-01-01

This paper explores how hypnotic principles can be systematically incorporated into the standard EMDR protocol to enhance various ego strength capacities during EMDR treatment. Expanding these skill areas can widen the therapeutic window of possibility for clients with a variety of complex clinical issues, including posttraumatic, dissociative or personality disorders, anxiety symptoms, and depressive difficulties. Clinical case examples are used to illustrate ways of integrating hypnotic principles within a proposed EMDR protocol to promote ego strengthening and facilitate therapeutic change.

Metadata registry and management system based on ISO 11179 for cancer clinical trials information system

PubMed Central

Park, Yu Rang; Kim*, Ju Han

2006-01-01

Standardized management of data elements (DEs) for Case Report Form (CRF) is crucial in Clinical Trials Information System (CTIS). Traditional CTISs utilize organization-specific definitions and storage methods for Des and CRFs. We developed metadata-based DE management system for clinical trials, Clinical and Histopathological Metadata Registry (CHMR), using international standard for metadata registry (ISO 11179) for the management of cancer clinical trials information. CHMR was evaluated in cancer clinical trials with 1625 DEs extracted from the College of American Pathologists Cancer Protocols for 20 major cancers. PMID:17238675

Systematic Evaluation of the Patient-Reported Outcome (PRO) Content of Clinical Trial Protocols

PubMed Central

Kyte, Derek; Duffy, Helen; Fletcher, Benjamin; Gheorghe, Adrian; Mercieca-Bebber, Rebecca; King, Madeleine; Draper, Heather; Ives, Jonathan; Brundage, Michael; Blazeby, Jane; Calvert, Melanie

2014-01-01

Background Qualitative evidence suggests patient-reported outcome (PRO) information is frequently absent from clinical trial protocols, potentially leading to inconsistent PRO data collection and risking bias. Direct evidence regarding PRO trial protocol content is lacking. The aim of this study was to systematically evaluate the PRO-specific content of UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme trial protocols. Methods and Findings We conducted an electronic search of the NIHR HTA programme database (inception to August 2013) for protocols describing a randomised controlled trial including a primary/secondary PRO. Two investigators independently reviewed the content of each protocol, using a specially constructed PRO-specific protocol checklist, alongside the ‘Standard Protocol Items: Recommendations for Interventional Trials’ (SPIRIT) checklist. Disagreements were resolved through discussion with a third investigator. 75 trial protocols were included in the analysis. Protocols included a mean of 32/51 (63%) SPIRIT recommendations (range 16–41, SD 5.62) and 11/33 (33%) PRO-specific items (range 4–18, SD 3.56). Over half (61%) of the PRO items were incomplete. Protocols containing a primary PRO included slightly more PRO checklist items (mean 14/33 (43%)). PRO protocol content was not associated with general protocol completeness; thus, protocols judged as relatively ‘complete’ using SPIRIT were still likely to have omitted a large proportion of PRO checklist items. Conclusions The PRO components of HTA clinical trial protocols require improvement. Information on the PRO rationale/hypothesis, data collection methods, training and management was often absent. This low compliance is unsurprising; evidence shows existing PRO guidance for protocol developers remains difficult to access and lacks consistency. Study findings suggest there are a number of PRO protocol checklist items that are not fully addressed by the current SPIRIT statement. We therefore advocate the development of consensus-based supplementary guidelines, aimed at improving the completeness and quality of PRO content in clinical trial protocols. PMID:25333349

Photographing Injuries in the Acute Care Setting: Development and Evaluation of a Standardized Protocol for Research, Forensics, and Clinical Practice

PubMed Central

Bloemen, Elizabeth M.; Rosen, Tony; Schiroo, Justina A. Cline; Clark, Sunday; Mulcare, Mary R.; Stern, Michael E.; Mysliwiec, Regina; Flomenbaum, Neal E.; Lachs, Mark S.; Hargarten, Stephen

2016-01-01

Background Photographing injuries in the acute setting allows for improved documentation as well as assessment by clinicians and others who have not personally examined a patient. This tool is important, particularly for telemedicine, tracking of wound healing, the evaluation of potential abuse, and injury research. Despite this, protocols to ensure standardization of photography in clinical practice, forensics, or research have not been published. In preparation for a study of injury patterns in elder abuse and geriatric falls, our goal was to develop and evaluate a protocol for standardized photography of injuries that may be broadly applied. Methods We conducted a literature review for techniques and standards in medical, forensic, and legal photography. We developed a novel protocol describing types of photographs and body positioning for eight body regions, including instructional diagrams. We revised it iteratively in consultation with experts in medical photography; forensics; and elder, child, and domestic abuse. The resulting protocol requires a minimum of four photos of each injury at multiple distances with and without a ruler/color guide. To evaluate the protocol’s efficacy, multiple research assistants without previous photography experience photographed injuries from a convenience sample of elderly patients presenting to a single large, urban, academic emergency department. A selection of these patients’ images were then evaluated in a blinded fashion by four nontreating emergency medicine physicians and the inter-rater reliability between these physicians was calculated. Results Among the 131 injuries, from 53 patients, photographed by 18 photographers using this protocol, photographs of 25 injuries (10 bruises, seven lacerations, and eight abrasions) were used to assess characterization of the injury. Physicians’ characterizations of the injuries were reliable for the size of the injury (κ = 0.91, 95% confidence interval [CI] = 0.77 to 1.00), side of the body (κ = 0.97, 95% CI = 0.88 to 1.00), precise location of the injury (κ = 0.74, 95% CI = 0.63 = 0.81), and type of abrasion (κ = 0.76, 95% CI = 0.45 to 1.00). The exact shape of the injury (κ = 0.44, 95% CI = 0.17 to 0.51), and the primary color of bruises (κ = 0.37, 95% CI = 0.25 to 0.48) were not as reliably characterized. Conclusions Standardizing the documentation of injuries with photographs for clinical and research assessment can be conducted by nonprofessional photographers. A photography protocol will ensure that this important mechanism for documentation is optimized. PMID:26932497

Development of a cross-disciplinary continuous insulin infusion protocol for non-critically ill patients in a French university hospital.

PubMed

Bernard, Lise; Roche, Béatrice; Batisse, Marie; Maqdasy, Salwan; Terral, Daniel; Sautou, Valérie; Tauveron, Igor

2016-10-01

In non-critically ill patients, the use of an insulin syringe pump allows the management of temporary situations during which other therapies cannot be used (failure of subcutaneous injections, awaiting advice from the diabetes team, emergency situations, prolonged corticosteroid therapy, initiation of an artificial nutrition, need for a fasting status, etc.). To manage the risks related to this «never event», the use of a standard validated protocol for insulin administration and monitoring is an essential prerequisite. To this end, a multidisciplinary approach is recommended. With the support of our subcommission «Endocrinology-Diabetology», we proceeded with a «step-by-step process» to create such a standardized protocol: (1) review of all existing protocols in our hospital; (2) overview of the literature data concerning insulin infusion protocols developed by multidisciplinary teams in France and abroad; (3) development of a standardized protocol for non-intensive care unit patients, respecting the current recommendations and adapting it to the working habits of health teams; and (4) validation of the protocol Two protocols based on the same structure but adapted to the health status of the patient have been developed. The protocols are divided in to three parts: (1) golden rules to make the use of the protocol appropriate and safe; (2) the algorithm (a double entry table) corresponding to a dynamic adaptation of insulin doses, clearly defining the target and the 'at risk situations'; and (3) practical aspects of the protocol: preparation of the syringe, treatment initiation and traceability. The protocols have been validated by the institution. Our standardized insulin infusion protocol is simple, easy to implement, safe and is likely to be applicable in diverse care units. However, the efficiency, safety and the workability of our protocols have to be clinically evaluated. © 2016 John Wiley & Sons, Ltd.

Development of new method and protocol for cryopreservation related to embryo and oocytes freezing in terms of fertilization rate: A comparative study including review of literature

PubMed Central

Barik, Mayadhar; Bajpai, Minu; Patnaik, Santosh; Mishra, Pravash; Behera, Priyamadhaba; Dwivedi, Sada Nanda

2016-01-01

Background: Cryopreservation is basically related to meritorious thin samples or small clumps of cells that are cooled quickly without loss. Our main objective is to establish and formulate an innovative method and protocol development for cryopreservation as a gold standard for clinical uses in laboratory practice and treatment. The knowledge regarding usefulness of cryopreservation in clinical practice is essential to carry forward the clinical practice and research. Materials and Methods: We are trying to compare different methods of cryopreservation (in two dozen of cells) at the same time we compare the embryo and oocyte freezing interms of fertilization rate according to the International standard protocol. Results: The combination of cryoprotectants and regimes of rapid cooling and rinsing during warming often allows successful cryopreservation of biological materials, particularly cell suspensions or thin tissue samples. Examples include semen, blood, tissue samples like tumors, histological cross-sections, human eggs and human embryos. Although presently many studies have reported that the children born from frozen embryos or “frosties,” show consistently positive results with no increase in birth defects or development abnormalities is quite good enough and similar to our study (50–85%). Conclusions: We ensure that cryopreservation technology provided useful cell survivability, tissue and organ preservation in a proper way. Although it varies according to different laboratory conditions, it is certainly beneficial for patient's treatment and research. Further studies are needed for standardization and development of new protocol. PMID:27512686

Natural Language Processing-Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study.

PubMed

Kaufman, David R; Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-10-28

The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)-enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user's experience. The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods ("protocols") of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. ©David R. Kaufman, Barbara Sheehan, Peter Stetson, Ashish R. Bhatt, Adele I. Field, Chirag Patel, James Mark Maisel. Originally published in JMIR Medical Informatics (http://medinform.jmir.org), 28.10.2016.

HIV patient retention: the implementation of a North Carolina clinic-based protocol.

PubMed

Keller, Jennifer; Heine, Amy; LeViere, Anna Finestone; Donovan, Jenna; Wilkin, Aimee; Sullivan, Kristen; Quinlivan, Evelyn Byrd

2017-05-01

Decreased visit attendance leads to poor health outcomes, decreased viral suppression, and higher mortality rates for persons living with HIV. Retention in care is an important factor in improving health status for people living with HIV but continues to be a challenge in clinical settings. This paper details the development and implementation of the NC-LINK Retention Protocol, a clinic-based protocol to locate and reengage out-of-care patients, as part of overall clinic retention efforts. The protocol was implemented as one of four interventions of the NC-LINK Systems and Linkages Project, a multi-site initiative funded by the HIV/AIDS Bureau and the Special Projects of National Significance. Lists of out-of-care patients who had not received HIV medical care in over nine months and did not have a future appointment were created each month. Patient navigators, case managers, and other staff then followed a standardized protocol to locate and reengage these patients in care. A total of 452 patients were identified for reengagement services. Of those, 194 (43%) returned to care, 108 (24%) had another definitive outcome (incarcerated, deceased, or relocated) and 150 (33%) were referred for additional follow-up to locate and reengage in care. In summary, 67% of patients were located through the efforts of the clinic staff. The results of this intervention indicate that it is possible to successfully integrate a protocol into the existing infrastructure of a clinic and reengage a majority of out-of-care patients into medical care.

Broth Microdilution In Vitro Screening: An Easy and Fast Method to Detect New Antifungal Compounds.

PubMed

de-Souza-Silva, Calliandra Maria; Guilhelmelli, Fernanda; Zamith-Miranda, Daniel; de Oliveira, Marco Antônio; Nosanchuk, Joshua Daniel; Silva-Pereira, Ildinete; Albuquerque, Patrícia

2018-02-14

Fungal infections have become an important medical condition in the last decades, but the number of available antifungal drugs is limited. In this scenario, the search for new antifungal drugs is necessary. The protocol reported here details a method to screen peptides for their antifungal properties. It is based on the broth microdilution susceptibility test from the Clinical and Laboratory Standards Institute (CLSI) M27-A3 guidelines with modifications to suit the research of antimicrobial peptides as potential new antifungals. This protocol describes a functional assay to evaluate the activity of antifungal compounds and may be easily modified to suit any particular class of molecules under investigation. Since the assays are performed in 96-well plates using small volumes, a large-scale screening can be completed in a short amount of time, especially if carried out in an automation setting. This procedure illustrates how a standardized and adjustable clinical protocol can help the bench-work pursuit of new molecules to improve the therapy of fungal diseases.

Spontaneous Swallow Frequency Compared with Clinical Screening in the Identification of Dysphagia in Acute Stroke

PubMed Central

Crary, Michael A.; Carnaby, Giselle D.; Sia, Isaac

2017-01-01

Background The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. Methods In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Results Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Conclusions Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. PMID:25088166

Spontaneous swallow frequency compared with clinical screening in the identification of dysphagia in acute stroke.

PubMed

Crary, Michael A; Carnaby, Giselle D; Sia, Isaac

2014-09-01

The aim of this study was to compare spontaneous swallow frequency analysis (SFA) with clinical screening protocols for identification of dysphagia in acute stroke. In all, 62 patients with acute stroke were evaluated for spontaneous swallow frequency rates using a validated acoustic analysis technique. Independent of SFA, these same patients received a routine nurse-administered clinical dysphagia screening as part of standard stroke care. Both screening tools were compared against a validated clinical assessment of dysphagia for acute stroke. In addition, psychometric properties of SFA were compared against published, validated clinical screening protocols. Spontaneous SFA differentiates patients with versus without dysphagia after acute stroke. Using a previously identified cut point based on swallows per minute, spontaneous SFA demonstrated superior ability to identify dysphagia cases compared with a nurse-administered clinical screening tool. In addition, spontaneous SFA demonstrated equal or superior psychometric properties to 4 validated, published clinical dysphagia screening tools. Spontaneous SFA has high potential to identify dysphagia in acute stroke with psychometric properties equal or superior to clinical screening protocols. Copyright © 2014 National Stroke Association. Published by Elsevier Inc. All rights reserved.

Safety and cost-effectiveness of a clinical protocol implemented to standardize the use of Crotalidae polyvalent immune Fab antivenom at an academic medical center.

PubMed

Weant, Kyle A; Bowers, Rebecca C; Reed, Janelle; Braun, Kristopher A; Dodd, David M; Baker, Stephanie N

2012-05-01

To evaluate the safety and cost-effectiveness of a clinical protocol adopted in June 2006 that included a comprehensive, objective assessment of snake bite envenomations and standardized the use of Crotalidae polyvalent immune Fab antivenom (FabAV). Retrospective medical record review. Academic medical center that serves as the regional level I trauma center. Seventy-five adults treated with FabAV for snake envenomations in the emergency department between June 1, 2003, and June 1, 2009; 30 patients received treatment according to the protocol (treatment group), and 45 patients received treatment that did not adhere to the protocol (control group). Demographic and envenomation characteristics, as well as treatment details, were collected for all patients. In addition, information on quantity of FabAV vials required, length of hospital stay, and length of intensive care unit stay were compared between the treatment and control groups. In the treatment group, significantly fewer vials of FabAV were used (2.5 vs 4.727 vials, p=0.007). This decreased in usage correlated to a cost savings of approximately $2000/patient. Despite no significant difference in the severity of the envenomations between the two groups (p=0.379), the treatment group experienced a significantly shorter hospital length of stay (1.933 vs 2.791 days, p=0.030). No significant difference in the progression to fasciotomy or the development of allergic reactions was noted between the two groups. Use of a clinical protocol related to snake envenomations resulted in approximately two fewer vials of FabAV required for each patient. In addition, the treatment group experienced a shorter hospital length of stay without a corresponding increase in adverse events or envenomation progression. Data show that use of the protocol was cost-effective. The development of institution-specific multidisciplinary protocols regarding snake bite envenomations is recommended. Clinical pharmacists can play a vital role in the protocol development to ensure that optimal care is provided for this distinct patient population. © 2012 Pharmacotherapy Publications, Inc.

BRIDG: a domain information model for translational and clinical protocol-driven research.

PubMed

Becnel, Lauren B; Hastak, Smita; Ver Hoef, Wendy; Milius, Robert P; Slack, MaryAnn; Wold, Diane; Glickman, Michael L; Brodsky, Boris; Jaffe, Charles; Kush, Rebecca; Helton, Edward

2017-09-01

It is critical to integrate and analyze data from biological, translational, and clinical studies with data from health systems; however, electronic artifacts are stored in thousands of disparate systems that are often unable to readily exchange data. To facilitate meaningful data exchange, a model that presents a common understanding of biomedical research concepts and their relationships with health care semantics is required. The Biomedical Research Integrated Domain Group (BRIDG) domain information model fulfills this need. Software systems created from BRIDG have shared meaning "baked in," enabling interoperability among disparate systems. For nearly 10 years, the Clinical Data Standards Interchange Consortium, the National Cancer Institute, the US Food and Drug Administration, and Health Level 7 International have been key stakeholders in developing BRIDG. BRIDG is an open-source Unified Modeling Language-class model developed through use cases and harmonization with other models. With its 4+ releases, BRIDG includes clinical and now translational research concepts in its Common, Protocol Representation, Study Conduct, Adverse Events, Regulatory, Statistical Analysis, Experiment, Biospecimen, and Molecular Biology subdomains. The model is a Clinical Data Standards Interchange Consortium, Health Level 7 International, and International Standards Organization standard that has been utilized in national and international standards-based software development projects. It will continue to mature and evolve in the areas of clinical imaging, pathology, ontology, and vocabulary support. BRIDG 4.1.1 and prior releases are freely available at https://bridgmodel.nci.nih.gov . © The Author 2017. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com

Sub-Symptomatic Aerobic Exercise for Patients with Post-Concussion Syndrome: A Critically Appraised Topic.

PubMed

Ritter, Katrina G; Hussey, Matthew J; Valovich McLeod, Tamara C

2017-09-27

Clinical Scenario: Patients who experience prolonged concussion symptoms can be diagnosed with Post-Concussion Syndrome (PCS) when those symptoms persist past 4 weeks. Aerobic exercise protocols have been shown to be effective in improving physical and mental aspects of health. Emerging research suggests that aerobic exercise maybe useful as a treatment for PCS, where exercise allows patients to feel less isolated and more active during the recovery process. Is aerobic exercise more beneficial in reducing symptoms than current standard care in patients with prolonged symptoms or PCS lasting longer than 4 weeks? Summary of Key Findings: After a thorough literature search, 4 studies were selected relevant to the clinical question. Of the 4 studies, 1 was a randomized control trial and 3 were case series. All 4 studies investigate aerobic exercise protocol as treatment for PCS. 1-4 Three articles demonstrated a greater rate of symptom improvement from baseline assessment to follow-up after a controlled sub-symptomatic aerobic exercise program. 2-4 One study showed a decrease in symptoms in the aerobic exercise group compared to the full body stretching group. 1 Clinical Bottom Line: There is moderate evidence to support sub-symptomatic aerobic exercise as a treatment of PCS, therefore it should be considered as a clinical option for reducing PCS and prolonged concussion symptoms. A previously validated protocol, such as the Buffalo Concussion Treadmill Test, Balke Protocol, or Rating of Perceived Exertion (RPE) as mentioned in this critically appraised topic should be used to measure baseline values and treatment progression. Strength of Recommendation: Level C evidence exists that aerobic exercise protocol is more effective than the current standard of care in treating PCS.

ANDRO-IVF: a novel protocol for poor responders to IVF controlled ovarian stimulation

PubMed Central

Bercaire, Ludmila; Nogueira, Sara MB; Lima, Priscila CM; Alves, Vanessa R; Donadio, Nilka; Dzik, Artur; Cavagna, Mario; Fanchin, Renato

2018-01-01

Objective This study aimed to assess a novel protocol designed to improve poor ovarian response through intra-ovarian androgenization. The endpoints were: number of oocytes and mature oocytes retrieved, fertilization, cancellation and pregnancy rates. Methods This prospective crossover study enrolled poor responders from previous ovarian stimulation cycles submitted to a novel protocol called ANDRO-IVF. The protocol included pretreatment with transdermal AndroGel(r) (Besins) 25 mg, oral letrozole 2.5 mg and subcutaneous hCG 2500 IU; cycle control was performed with estradiol valerate and micronized progesterone; ovarian stimulation was attained with gonadotropins FSH/LH 450 IU, GnRH antagonist and hCG 5000 IU. Results Fourteen poor responders were enrolled. One patient did not meet the inclusion criteria. Thirteen patients previously summited to the standard protocol were offered the ANDRO-IVF Protocol.-Standard Protocol: Mean age: 35.30 years; cancellation rate: 61.53%; mean number of MII oocytes retrieved per patient: 1.8; fertilization rate: 33.33%. Only two patients had embryo transfers, and none got pregnant.-ANDRO-IVF Protocol: Mean age: 35.83 years; cancellation rate: 7.69%; mean number of oocytes retrieved per patient: 5.58, MII oocytes: 3.91. ICSI was performed in 84.61% of the patients and a mean of 1.5 embryos were transferred per patient. Fertilization rate: 62.5%; cumulative pregnancy rate: 16.66%; mean duration of stimulation: 9.77 days. Conclusion ANDRO-IVF allows intra-ovarian androgenization by increasing serum and intra-follicular androgen levels and preventing androgen aromatization. This protocol apparently improved clinical outcomes of poor responders in parameters such as number of oocytes retrieved and clinical pregnancy rates. Further randomized controlled trials are needed to confirm these findings. PMID:29303236

Quantitative and qualitative comparison of MR imaging of the temporomandibular joint at 1.5 and 3.0 T using an optimized high-resolution protocol

PubMed Central

Spinner, Georg; Wyss, Michael; Erni, Stefan; Ettlin, Dominik A; Nanz, Daniel; Ulbrich, Erika J; Gallo, Luigi M; Andreisek, Gustav

2016-01-01

Objectives: To quantitatively and qualitatively compare MRI of the temporomandibular joint (TMJ) using an optimized high-resolution protocol at 3.0 T and a clinical standard protocol at 1.5 T. Methods: A phantom and 12 asymptomatic volunteers were MR imaged using a 2-channel surface coil (standard TMJ coil) at 1.5 and 3.0 T (Philips Achieva and Philips Ingenia, respectively; Philips Healthcare, Best, Netherlands). Imaging protocol consisted of coronal and oblique sagittal proton density-weighted turbo spin echo sequences. For quantitative evaluation, a spherical phantom was imaged. Signal-to-noise ratio (SNR) maps were calculated on a voxelwise basis. For qualitative evaluation, all volunteers underwent MRI of the TMJ with the jaw in closed position. Two readers independently assessed visibility and delineation of anatomical structures of the TMJ and overall image quality on a 5-point Likert scale. Quantitative and qualitative measurements were compared between field strengths. Results: The quantitative analysis showed similar SNR for the high-resolution protocol at 3.0 T compared with the clinical protocol at 1.5 T. The qualitative analysis showed significantly better visibility and delineation of clinically relevant anatomical structures of the TMJ, including the TMJ disc and pterygoid muscle as well as better overall image quality at 3.0 T than at 1.5 T. Conclusions: The presented results indicate that expected gains in SNR at 3.0 T can be used to increase the spatial resolution when imaging the TMJ, which translates into increased visibility and delineation of anatomical structures of the TMJ. Therefore, imaging at 3.0 T should be preferred over 1.5 T for imaging the TMJ. PMID:26371077

Quantitative and qualitative comparison of MR imaging of the temporomandibular joint at 1.5 and 3.0 T using an optimized high-resolution protocol.

PubMed

Manoliu, Andrei; Spinner, Georg; Wyss, Michael; Erni, Stefan; Ettlin, Dominik A; Nanz, Daniel; Ulbrich, Erika J; Gallo, Luigi M; Andreisek, Gustav

2016-01-01

To quantitatively and qualitatively compare MRI of the temporomandibular joint (TMJ) using an optimized high-resolution protocol at 3.0 T and a clinical standard protocol at 1.5 T. A phantom and 12 asymptomatic volunteers were MR imaged using a 2-channel surface coil (standard TMJ coil) at 1.5 and 3.0 T (Philips Achieva and Philips Ingenia, respectively; Philips Healthcare, Best, Netherlands). Imaging protocol consisted of coronal and oblique sagittal proton density-weighted turbo spin echo sequences. For quantitative evaluation, a spherical phantom was imaged. Signal-to-noise ratio (SNR) maps were calculated on a voxelwise basis. For qualitative evaluation, all volunteers underwent MRI of the TMJ with the jaw in closed position. Two readers independently assessed visibility and delineation of anatomical structures of the TMJ and overall image quality on a 5-point Likert scale. Quantitative and qualitative measurements were compared between field strengths. The quantitative analysis showed similar SNR for the high-resolution protocol at 3.0 T compared with the clinical protocol at 1.5 T. The qualitative analysis showed significantly better visibility and delineation of clinically relevant anatomical structures of the TMJ, including the TMJ disc and pterygoid muscle as well as better overall image quality at 3.0 T than at 1.5 T. The presented results indicate that expected gains in SNR at 3.0 T can be used to increase the spatial resolution when imaging the TMJ, which translates into increased visibility and delineation of anatomical structures of the TMJ. Therefore, imaging at 3.0 T should be preferred over 1.5 T for imaging the TMJ.

Natural Language Processing–Enabled and Conventional Data Capture Methods for Input to Electronic Health Records: A Comparative Usability Study

PubMed Central

Sheehan, Barbara; Stetson, Peter; Bhatt, Ashish R; Field, Adele I; Patel, Chirag; Maisel, James Mark

2016-01-01

Background The process of documentation in electronic health records (EHRs) is known to be time consuming, inefficient, and cumbersome. The use of dictation coupled with manual transcription has become an increasingly common practice. In recent years, natural language processing (NLP)–enabled data capture has become a viable alternative for data entry. It enables the clinician to maintain control of the process and potentially reduce the documentation burden. The question remains how this NLP-enabled workflow will impact EHR usability and whether it can meet the structured data and other EHR requirements while enhancing the user’s experience. Objective The objective of this study is evaluate the comparative effectiveness of an NLP-enabled data capture method using dictation and data extraction from transcribed documents (NLP Entry) in terms of documentation time, documentation quality, and usability versus standard EHR keyboard-and-mouse data entry. Methods This formative study investigated the results of using 4 combinations of NLP Entry and Standard Entry methods (“protocols”) of EHR data capture. We compared a novel dictation-based protocol using MediSapien NLP (NLP-NLP) for structured data capture against a standard structured data capture protocol (Standard-Standard) as well as 2 novel hybrid protocols (NLP-Standard and Standard-NLP). The 31 participants included neurologists, cardiologists, and nephrologists. Participants generated 4 consultation or admission notes using 4 documentation protocols. We recorded the time on task, documentation quality (using the Physician Documentation Quality Instrument, PDQI-9), and usability of the documentation processes. Results A total of 118 notes were documented across the 3 subject areas. The NLP-NLP protocol required a median of 5.2 minutes per cardiology note, 7.3 minutes per nephrology note, and 8.5 minutes per neurology note compared with 16.9, 20.7, and 21.2 minutes, respectively, using the Standard-Standard protocol and 13.8, 21.3, and 18.7 minutes using the Standard-NLP protocol (1 of 2 hybrid methods). Using 8 out of 9 characteristics measured by the PDQI-9 instrument, the NLP-NLP protocol received a median quality score sum of 24.5; the Standard-Standard protocol received a median sum of 29; and the Standard-NLP protocol received a median sum of 29.5. The mean total score of the usability measure was 36.7 when the participants used the NLP-NLP protocol compared with 30.3 when they used the Standard-Standard protocol. Conclusions In this study, the feasibility of an approach to EHR data capture involving the application of NLP to transcribed dictation was demonstrated. This novel dictation-based approach has the potential to reduce the time required for documentation and improve usability while maintaining documentation quality. Future research will evaluate the NLP-based EHR data capture approach in a clinical setting. It is reasonable to assert that EHRs will increasingly use NLP-enabled data entry tools such as MediSapien NLP because they hold promise for enhancing the documentation process and end-user experience. PMID:27793791

Challenges in standardization of blood pressure measurement at the population level.

PubMed

Tolonen, Hanna; Koponen, Päivikki; Naska, Androniki; Männistö, Satu; Broda, Grazyna; Palosaari, Tarja; Kuulasmaa, Kari

2015-04-10

Accurate blood pressure measurements are needed in clinical practice, intervention studies and health examination surveys. Blood pressure measurements are sensitive: their accuracy can be affected by measurement environment, behaviour of the subject, measurement procedures, devices used for the measurement and the observer. To minimize errors in blood pressure measurement, a standardized measurement protocol is needed. The European Health Examination Survey (EHES) Pilot project was conducted in 2009-2012. A pilot health examination survey was conducted in 12 countries using a standardized protocol. The measurement protocols used in each survey, training provided for the measurers, measurement data, and observations during site visits were collected and evaluated to assess the level of standardization. The EHES measurement protocol for blood pressure was followed accurately in all 12 pilot surveys. Most of the surveys succeeded in organizing a quiet and comfortable measurement environment, and staff instructed survey participants appropriately before examination visits. In all surveys, blood pressure was measured three times, from the right arm in a sitting posture. The biggest variation was in the device used for the blood pressure measurement. It is possible to reach a high level of standardization for blood pressure measurements across countries and over time. A detailed, standardized measurement protocol, and adequate training and monitoring during the fieldwork and centrally organized quality assessment of the data are needed. The recent EU regulation banning the sale of mercury sphygmomanometer in European Union Member States has set new challenges for the standardization of measurement devices since the validity of oscillometric measurements is device-specific and performance of aneroid devices depends very much on calibration.

Lack of evidence of a beneficial effect of azathioprine in dogs treated with prednisolone for idiopathic immune-mediated hemolytic anemia: a retrospective cohort study.

PubMed

Piek, Christine J; van Spil, Willem Evert; Junius, Greet; Dekker, Aldo

2011-04-13

Azathioprine is used as an immunosuppressant in canine immune-mediated hemolytic anemia (IMHA), but this potentially toxic and carcinogenic drug has not been proven to be beneficial. The aim of this study was to determine the difference in outcome and survival of dogs with idiopathic IMHA treated with a protocol that included azathioprine and prednisolone versus a protocol that included prednisolone alone. The study included 222 dogs with a hematocrit lower than 0.30 L/L and either a positive Coombs' test or spherocytosis and no evidence of diseases that could trigger IMHA. The clinical and laboratory data at the time of diagnosis and the response to therapy and survival were compared in dogs treated according to the prednisolone and azathioprine protocol (AP protocol; n = 149) and dogs treated according to the prednisolone protocol (P protocol; n = 73). At study entry, the two groups were comparable, except that thrombocyte counts were significantly lower and clinical signs had been present significantly longer in the AP protocol group. No significant difference in survival was found between the two groups: the 1-year survival was 64% (95% CI 54 - 77%) in the P protocol group and 69% (95% CI 59-80%) in the AP protocol group, respectively. Azathioprine would appear not to be beneficial as standard treatment for all cases of IMHA; however, a blinded, randomized clinical trial is needed to establish whether outcome is different with the two treatment protocols.

Effects of Arnica comp.-Heel® on reducing cardiovascular events in patients with stable coronary disease.

PubMed

Fioranelli, Massimo; Bianchi, Maria; Roccia, Maria G; Di Nardo, Veronica

2016-02-01

The purpose of the study was to evaluate the effectiveness of the treatment with one tablet a day of a low dose multicomponent medication (Arnica comp.-Heel® tablets) with anti-inflammatory properties in order to reduce the risk of cardiovascular events in patients with clinically stable coronary disease. The presence of inflammatory cells in atherosclerotic plaques of patients with stable coronary disease indicates the possibility to act by inhibiting the inflammatory phenomenon with Arnica comp.-Heel® tablets reducing the risk of instability of the plaque and, consequently, improving the clinical outcome in patients with stable coronary disease. Within this retrospective observational spontaneous clinical study 44 patients (31 males and 13 females) all presenting stable coronary artery disease were evaluated; 25 subjects were treated with only acetylsalicylic acid and/or clopidogrel in association with statins (standard therapeutic protocol) while for the other 18 subjects the standard therapeutic protocol was integrated with Arnica comp.-Heel® (one sublingual tablet/day). The primary outcome was to evaluate the incidence of acute coronary syndrome, out-of-hospital cardiac arrest, or non-cardioembolic ischemic stroke. The evaluation of the primary outcome showed that in the group of patients (18) who received the standard therapeutic protocol plus Arnica comp.-Heel® only one cardiovascular event was registered (5.6%) while in the group treated only with standard therapy 4 events were recorded in 25 patients (16%). The treatment with Arnica comp.-Heel® (one tablet/day) in combination with standard therapies for secondary prevention is effective in reducing the incidence of cardiovascular events in patients with stable coronary artery disease.

Optimization of a secondary VOI protocol for lung imaging in a clinical CT scanner.

PubMed

Larsen, Thomas C; Gopalakrishnan, Vissagan; Yao, Jianhua; Nguyen, Catherine P; Chen, Marcus Y; Moss, Joel; Wen, Han

2018-05-21

We present a solution to meet an unmet clinical need of an in-situ "close look" at a pulmonary nodule or at the margins of a pulmonary cyst revealed by a primary (screening) chest CT while the patient is still in the scanner. We first evaluated options available on current whole-body CT scanners for high resolution screening scans, including ROI reconstruction of the primary scan data and HRCT, but found them to have insufficient SNR in lung tissue or discontinuous slice coverage. Within the capabilities of current clinical CT systems, we opted for the solution of a secondary, volume-of-interest (VOI) protocol where the radiation dose is focused into a short-beam axial scan at the z position of interest, combined with a small-FOV reconstruction at the xy position of interest. The objective of this work was to design a VOI protocol that is optimized for targeted lung imaging in a clinical whole-body CT system. Using a chest phantom containing a lung-mimicking foam insert with a simulated cyst, we identified the appropriate scan mode and optimized both the scan and recon parameters. The VOI protocol yielded 3.2 times the texture amplitude-to-noise ratio in the lung-mimicking foam when compared to the standard chest CT, and 8.4 times the texture difference between the lung mimicking and reference foams. It improved details of the wall of the simulated cyst and better resolution in a line-pair insert. The Effective Dose of the secondary VOI protocol was 42% on average and up to 100% in the worst-case scenario of VOI positioning relative to the standard chest CT. The optimized protocol will be used to obtain detailed CT textures of pulmonary lesions, which are biomarkers for the type and stage of lung diseases. Published 2018. This article is a U.S. Government work and is in the public domain in the USA.

The Rockefeller University Navigation Program: A Structured Multidisciplinary Protocol Development and Educational Program to Advance Translational Research

PubMed Central

Kost, Rhonda G.; Dowd, Kathleen A.; Hurley, Arlene M.; Rainer, Tyler‐Lauren; Coller, Barry S.

2014-01-01

Abstract The development of translational clinical research protocols is complex. To assist investigators, we developed a structured supportive guidance process (Navigation) to expedite protocol development to the standards of good clinical practice (GCP), focusing on research ethics and integrity. Navigation consists of experienced research coordinators leading investigators through a concerted multistep protocol development process from concept initiation to submission of the final protocol. To assess the effectiveness of Navigation, we collect data on the experience of investigators, the intensity of support required for protocol development, IRB review outcomes, and protocol start and completion dates. One hundred forty‐four protocols underwent Navigation and achieved IRB approval since the program began in 2007, including 37 led by trainee investigators, 26 led by MDs, 9 by MD/PhDs, 57 by PhDs, and 12 by investigators with other credentials (e.g., RN, MPH). In every year, more than 50% of Navigated protocols were approved by the IRB within 30 days. For trainees who had more than one protocol navigated, the intensity of Navigation support required decreased over time. Navigation can increase access to translational studies for basic scientists, facilitate GCP training for investigators, and accelerate development and approval of protocols of high ethical and scientific quality. PMID:24405608

Sequencing of hepatitis C virus for detection of resistance to direct-acting antiviral therapy: A systematic review.

PubMed

Bartlett, Sofia R; Grebely, Jason; Eltahla, Auda A; Reeves, Jacqueline D; Howe, Anita Y M; Miller, Veronica; Ceccherini-Silberstein, Francesca; Bull, Rowena A; Douglas, Mark W; Dore, Gregory J; Harrington, Patrick; Lloyd, Andrew R; Jacka, Brendan; Matthews, Gail V; Wang, Gary P; Pawlotsky, Jean-Michel; Feld, Jordan J; Schinkel, Janke; Garcia, Federico; Lennerstrand, Johan; Applegate, Tanya L

2017-07-01

The significance of the clinical impact of direct-acting antiviral (DAA) resistance-associated substitutions (RASs) in hepatitis C virus (HCV) on treatment failure is unclear. No standardized methods or guidelines for detection of DAA RASs in HCV exist. To facilitate further evaluations of the impact of DAA RASs in HCV, we conducted a systematic review of RAS sequencing protocols, compiled a comprehensive public library of sequencing primers, and provided expert guidance on the most appropriate methods to screen and identify RASs. The development of standardized RAS sequencing protocols is complicated due to a high genetic variability and the need for genotype- and subtype-specific protocols for multiple regions. We have identified several limitations of the available methods and have highlighted areas requiring further research and development. The development, validation, and sharing of standardized methods for all genotypes and subtypes should be a priority. ( Hepatology Communications 2017;1:379-390).

Security analysis of standards-driven communication protocols for healthcare scenarios.

PubMed

Masi, Massimiliano; Pugliese, Rosario; Tiezzi, Francesco

2012-12-01

The importance of the Electronic Health Record (EHR), that stores all healthcare-related data belonging to a patient, has been recognised in recent years by governments, institutions and industry. Initiatives like the Integrating the Healthcare Enterprise (IHE) have been developed for the definition of standard methodologies for secure and interoperable EHR exchanges among clinics and hospitals. Using the requisites specified by these initiatives, many large scale projects have been set up for enabling healthcare professionals to handle patients' EHRs. The success of applications developed in these contexts crucially depends on ensuring such security properties as confidentiality, authentication, and authorization. In this paper, we first propose a communication protocol, based on the IHE specifications, for authenticating healthcare professionals and assuring patients' safety. By means of a formal analysis carried out by using the specification language COWS and the model checker CMC, we reveal a security flaw in the protocol thus demonstrating that to simply adopt the international standards does not guarantee the absence of such type of flaws. We then propose how to emend the IHE specifications and modify the protocol accordingly. Finally, we show how to tailor our protocol for application to more critical scenarios with no assumptions on the communication channels. To demonstrate feasibility and effectiveness of our protocols we have fully implemented them.

Reproducibility of manifest refraction between surgeons and optometrists in a clinical refractive surgery practice.

PubMed

Reinstein, Dan Z; Yap, Timothy E; Carp, Glenn I; Archer, Timothy J; Gobbe, Marine

2014-03-01

To measure and compare the interobserver reproducibility of manifest refraction according to a standardized protocol for normal preoperative patients in a refractive surgery practice. Private clinic, London, United Kingdom. Retrospective case series. This retrospective study comprised patients attending 2 preoperative refractions before laser vision correction. The first manifest refraction was performed by 1 of 7 optometrists and the second manifest refraction by 1 of 2 surgeons, all trained using a standard manifest refraction protocol. Spherocylindrical data were converted into power vectors for analysis. The dioptric power differences between observers were calculated and analyzed. One thousand nine hundred twenty-two consecutive eyes were stratified into a myopia group and a hyperopia group and then further stratified by each surgeon-optometrist combination. The mean surgeon-optometrist dioptric power difference was 0.21 diopter (D) (range 0.15 to 0.32 D). The mean difference in spherical equivalent refraction was 0.03 D, with 95% of all refractions within ±0.44 D for all optometrist-surgeon combinations. The severity of myopic or hyperopic ametropia did not affect the interobserver reproducibility of the manifest refraction. There was close agreement in refraction between surgeons and optometrists using a standard manifest refraction protocol of less than 0.25 D. This degree of interobserver repeatability is similar to that in intraobserver repeatability studies published to date and may represent the value of training and the use of a standard manifest refraction protocol between refraction observers in a refractive surgery practice involving co-management between surgeons and optometrists. Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Validation of the BPLab(®) 24-hour blood pressure monitoring system according to the European standard BS EN 1060-4:2004 and British Hypertension Society protocol.

PubMed

Koudryavtcev, Sergey A; Lazarev, Vyacheslav M

2011-01-01

Automatic blood pressure (BP) measuring devices are more and more often used in BP self-checks and in 24-hour BP monitoring. Nowadays, 24-hour BP monitoring is a necessary procedure in arterial hypertension treatment. The aim of this study was to validate the BPLab(®) ambulatory blood pressure monitor according to the European standard BS EN 1060-4:2004 and the British Hypertension Society (BHS) protocol, as well as to work out solutions regarding the suitability of using this device in clinical practice. A group of 85 patients of both sexes and different ages, who voluntarily agreed to take part in the tests and were given detailed instructions on the measurement technique were recruited for this study. The results of the BP measurement obtained by a qualified operator using the BPLab(®) device were compared with the BP values measured using the Korotkov auscultatory method. Data were obtained simultaneously by two experts with experience of over 10 years and had completed a noninvasive BP measurement standardization training course. Discrepancies in the systolic and diastolic BP measurements (N = 510; 255 for each expert) were analyzed according to the criteria specified in the BHS-93 protocol. The device passed the requirements of the European Standard BS EN 1060-4:2004 and was graded 'A' according to the criteria of the BHS protocol for both systolic BP and diastolic BP. The BPLab(®) 24-hour ambulatory blood pressure monitoring device may be recommended for extensive clinical use.

The Wiley Protocol: an analysis of ethical issues.

PubMed

Rosenthal, M Sara

2008-01-01

: This review explores the ethical issues surrounding an unregulated protocol that is advertised to women through consumer books, the popular press, and the Internet, known as the Wiley Protocol. : A content analysis of relevant documents was conducted, followed by telephone interviews with investigators and former participants to verify facts. : The Wiley Protocol is an example of unregulated research involving potentially unsafe doses of bioidentical hormones applied to an unselected population of women. This protocol fails to use research ethics guidelines such as informed consent, investigator expertise, sound methodology, standardized data collection, and data safety monitoring. : Clinical ethics breaches include lack of full disclosure of risks, coercive influences, as well as misinformation about the study goals and safety. Breaches of professional ethics include conflicts of interest with respect to financial incentives, patient accrual, and inadequate standards of awareness and proficiency among participating investigators. It appears evident that the failure to regulate nutriceuticals and products of compounding pharmacy has provided the opportunity for these ethical violations.

Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application.

PubMed

Karakatsanis, Nicolas A; Lodge, Martin A; Tahari, Abdel K; Zhou, Y; Wahl, Richard L; Rahmim, Arman

2013-10-21

Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ~15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ~45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically acceptable sampling schedules examined. The framework was also applied to six FDG PET patient studies, demonstrating clinical feasibility. Both simulated and clinical results indicated enhanced contrast-to-noise ratios (CNRs) for Ki images in tumor regions with notable background FDG concentration, such as the liver, where SUV performed relatively poorly. Overall, the proposed framework enables enhanced quantification of physiological parameters across the whole body. In addition, the total acquisition length can be reduced from 45 to ~35 min and still achieve improved or equivalent CNR compared to SUV, provided the true Ki contrast is sufficiently high. In the follow-up companion paper, a set of advanced linear regression schemes is presented to particularly address the presence of noise, and attempt to achieve a better trade-off between the mean-squared error and the CNR metrics, resulting in enhanced task-based imaging.

Dynamic whole body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

PubMed Central

Karakatsanis, Nicolas A.; Lodge, Martin A.; Tahari, Abdel K.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

2013-01-01

Static whole body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single bed-coverage limiting the axial field-of-view to ~15–20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole body PET acquisition protocol of ~45min total length is presented, composed of (i) an initial 6-min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (6 passes x 7 bed positions, each scanned for 45sec). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares (OLS) Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of 10 different clinically acceptable sampling schedules examined. The framework was also applied to six FDG PET patient studies, demonstrating clinical feasibility. Both simulated and clinical results indicated enhanced contrast-to-noise ratios (CNRs) for Ki images in tumor regions with notable background FDG concentration, such as the liver, where SUV performed relatively poorly. Overall, the proposed framework enables enhanced quantification of physiological parameters across the whole-body. In addition, the total acquisition length can be reduced from 45min to ~35min and still achieve improved or equivalent CNR compared to SUV, provided the true Ki contrast is sufficiently high. In the follow-up companion paper, a set of advanced linear regression schemes is presented to particularly address the presence of noise, and attempt to achieve a better trade-off between the mean-squared error (MSE) and the CNR metrics, resulting in enhanced task-based imaging. PMID:24080962

Dynamic whole-body PET parametric imaging: I. Concept, acquisition protocol optimization and clinical application

NASA Astrophysics Data System (ADS)

Karakatsanis, Nicolas A.; Lodge, Martin A.; Tahari, Abdel K.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

2013-10-01

Static whole-body PET/CT, employing the standardized uptake value (SUV), is considered the standard clinical approach to diagnosis and treatment response monitoring for a wide range of oncologic malignancies. Alternative PET protocols involving dynamic acquisition of temporal images have been implemented in the research setting, allowing quantification of tracer dynamics, an important capability for tumor characterization and treatment response monitoring. Nonetheless, dynamic protocols have been confined to single-bed-coverage limiting the axial field-of-view to ˜15-20 cm, and have not been translated to the routine clinical context of whole-body PET imaging for the inspection of disseminated disease. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. We investigate solutions to address the challenges of: (i) long acquisitions, (ii) small number of dynamic frames per bed, and (iii) non-invasive quantification of kinetics in the plasma. In the present study, a novel dynamic (4D) whole-body PET acquisition protocol of ˜45 min total length is presented, composed of (i) an initial 6 min dynamic PET scan (24 frames) over the heart, followed by (ii) a sequence of multi-pass multi-bed PET scans (six passes × seven bed positions, each scanned for 45 s). Standard Patlak linear graphical analysis modeling was employed, coupled with image-derived plasma input function measurements. Ordinary least squares Patlak estimation was used as the baseline regression method to quantify the physiological parameters of tracer uptake rate Ki and total blood distribution volume V on an individual voxel basis. Extensive Monte Carlo simulation studies, using a wide set of published kinetic FDG parameters and GATE and XCAT platforms, were conducted to optimize the acquisition protocol from a range of ten different clinically acceptable sampling schedules examined. The framework was also applied to six FDG PET patient studies, demonstrating clinical feasibility. Both simulated and clinical results indicated enhanced contrast-to-noise ratios (CNRs) for Ki images in tumor regions with notable background FDG concentration, such as the liver, where SUV performed relatively poorly. Overall, the proposed framework enables enhanced quantification of physiological parameters across the whole body. In addition, the total acquisition length can be reduced from 45 to ˜35 min and still achieve improved or equivalent CNR compared to SUV, provided the true Ki contrast is sufficiently high. In the follow-up companion paper, a set of advanced linear regression schemes is presented to particularly address the presence of noise, and attempt to achieve a better trade-off between the mean-squared error and the CNR metrics, resulting in enhanced task-based imaging.

Standardized training in nurse model travel clinics.

PubMed

Sofarelli, Theresa A; Ricks, Jane H; Anand, Rahul; Hale, Devon C

2011-01-01

International travel plays a significant role in the emergence and redistribution of major human diseases. The importance of travel medicine clinics for preventing morbidity and mortality has been increasingly appreciated, although few studies have thus far examined the management and staff training strategies that result in successful travel-clinic operations. Here, we describe an example of travel-clinic operation and management coordinated through the University of Utah School of Medicine, Division of Infectious Diseases. This program, which involves eight separate clinics distributed statewide, functions both to provide patient consult and care services, as well as medical provider training and continuing medical education (CME). Initial training, the use of standardized forms and protocols, routine chart reviews and monthly continuing education meetings are the distinguishing attributes of this program. An Infectious Disease team consisting of one medical doctor (MD) and a physician assistant (PA) act as consultants to travel nurses who comprise the majority of clinic staff. Eight clinics distributed throughout the state of Utah serve approximately 6,000 travelers a year. Pre-travel medical services are provided by 11 nurses, including 10 registered nurses (RNs) and 1 licensed practical nurse (LPN). This trained nursing staff receives continuing travel medical education and participate in the training of new providers. All nurses have completed a full training program and 7 of the 11 (64%) of clinic nursing staff serve more than 10 patients a week. Quality assurance measures show that approximately 0.5% of charts reviewed contain a vaccine or prescription error which require patient notification for correction. Using an initial training program, standardized patient intake forms, vaccine and prescription protocols, preprinted prescriptions, and regular CME, highly trained nurses at travel clinics are able to provide standardized pre-travel care to international travelers originating from Utah. © 2010 International Society of Travel Medicine.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2018-01-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2017 Elsevier Inc. All rights reserved.

Practical Considerations for Clinical PET/MR Imaging.

PubMed

Galgano, Samuel; Viets, Zachary; Fowler, Kathryn; Gore, Lael; Thomas, John V; McNamara, Michelle; McConathy, Jonathan

2017-05-01

Clinical PET/MR imaging is currently performed at a number of centers around the world as part of routine standard of care. This article focuses on issues and considerations for a clinical PET/MR imaging program, focusing on routine standard-of-care studies. Although local factors influence how clinical PET/MR imaging is implemented, the approaches and considerations described here intend to apply to most clinical programs. PET/MR imaging provides many more options than PET/computed tomography with diagnostic advantages for certain clinical applications but with added complexity. A recurring theme is matching the PET/MR imaging protocol to the clinical application to balance diagnostic accuracy with efficiency. Copyright © 2016 Elsevier Inc. All rights reserved.

Revised Recommendations of the Consortium of MS Centers Task Force for a Standardized MRI Protocol and Clinical Guidelines for the Diagnosis and Follow-Up of Multiple Sclerosis

PubMed Central

Traboulsee, A.; Simon, J.H.; Stone, L.; Fisher, E.; Jones, D.E.; Malhotra, A.; Newsome, S.D.; Oh, J.; Reich, D.S.; Richert, N.; Rammohan, K.; Khan, O.; Radue, E.-W.; Ford, C.; Halper, J.; Li, D.

2016-01-01

SUMMARY An international group of neurologists and radiologists developed revised guidelines for standardized brain and spinal cord MR imaging for the diagnosis and follow-up of MS. A brain MR imaging with gadolinium is recommended for the diagnosis of MS. A spinal cord MR imaging is recommended if the brain MR imaging is nondiagnostic or if the presenting symptoms are at the level of the spinal cord. A follow-up brain MR imaging with gadolinium is recommended to demonstrate dissemination in time and ongoing clinically silent disease activity while on treatment, to evaluate unexpected clinical worsening, to re-assess the original diagnosis, and as a new baseline before starting or modifying therapy. A routine brain MR imaging should be considered every 6 months to 2 years for all patients with relapsing MS. The brain MR imaging protocol includes 3D T1-weighted, 3D T2-FLAIR, 3D T2-weighted, post-single-dose gadolinium-enhanced T1-weighted sequences, and a DWI sequence. The progressive multifocal leukoencephalopathy surveillance protocol includes FLAIR and DWI sequences only. The spinal cord MR imaging protocol includes sagittal T1-weighted and proton attenuation, STIR or phase-sensitive inversion recovery, axial T2- or T2*-weighted imaging through suspicious lesions, and, in some cases, postcontrast gadolinium-enhanced T1-weighted imaging. The clinical question being addressed should be provided in the requisition for the MR imaging. The radiology report should be descriptive, with results referenced to previous studies. MR imaging studies should be permanently retained and available. The current revision incorporates new clinical information and imaging techniques that have become more available. PMID:26564433

Accelerated rehabilitation compared with a standard protocol after distal radial fractures treated with volar open reduction and internal fixation: a prospective, randomized, controlled study.

PubMed

Brehmer, Jess L; Husband, Jeffrey B

2014-10-01

There are relatively few studies in the literature that specifically evaluate accelerated rehabilitation protocols for distal radial fractures treated with open reduction and internal fixation (ORIF). The purpose of this study was to compare the early postoperative outcomes (at zero to twelve weeks postoperatively) of patients enrolled in an accelerated rehabilitation protocol with those of patients enrolled in a standard rehabilitation protocol following ORIF for a distal radial fracture. We hypothesized that patients with accelerated rehabilitation after volar ORIF for a distal radial fracture would have an earlier return to function compared with patients who followed a standard protocol. From November 2007 to November 2010, eighty-one patients with an unstable distal radial fracture were prospectively randomized to follow either an accelerated or a standard rehabilitation protocol after undergoing ORIF with a volar plate for a distal radial fracture. Both groups began with gentle active range of motion at three to five days postoperatively. At two weeks, the accelerated group initiated wrist/forearm passive range of motion and strengthening exercises, whereas the standard group initiated passive range of motion and strengthening at six weeks postoperatively. Patients were assessed at three to five days, two weeks, three weeks, four weeks, six weeks, eight weeks, twelve weeks, and six months postoperatively. Outcomes included Disabilities of the Arm, Shoulder and Hand (DASH) scores (primary outcome) and measurements of wrist flexion/extension, supination, pronation, grip strength, and palmar pinch. The patients in the accelerated group had better mobility, strength, and DASH scores at the early postoperative time points (zero to eight weeks postoperatively) compared with the patients in the standard rehabilitation group. The difference between the groups was both clinically relevant and statistically significant. Patients who follow an accelerated rehabilitation protocol that emphasizes motion immediately postoperatively and initiates strengthening at two weeks after volar ORIF of a distal radial fracture have an earlier return to function than patients who follow a more standard rehabilitation protocol. Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence. Copyright © 2014 by The Journal of Bone and Joint Surgery, Incorporated.

Development of an open metadata schema for prospective clinical research (openPCR) in China.

PubMed

Xu, W; Guan, Z; Sun, J; Wang, Z; Geng, Y

2014-01-01

In China, deployment of electronic data capture (EDC) and clinical data management system (CDMS) for clinical research (CR) is in its very early stage, and about 90% of clinical studies collected and submitted clinical data manually. This work aims to build an open metadata schema for Prospective Clinical Research (openPCR) in China based on openEHR archetypes, in order to help Chinese researchers easily create specific data entry templates for registration, study design and clinical data collection. Singapore Framework for Dublin Core Application Profiles (DCAP) is used to develop openPCR and four steps such as defining the core functional requirements and deducing the core metadata items, developing archetype models, defining metadata terms and creating archetype records, and finally developing implementation syntax are followed. The core functional requirements are divided into three categories: requirements for research registration, requirements for trial design, and requirements for case report form (CRF). 74 metadata items are identified and their Chinese authority names are created. The minimum metadata set of openPCR includes 3 documents, 6 sections, 26 top level data groups, 32 lower data groups and 74 data elements. The top level container in openPCR is composed of public document, internal document and clinical document archetypes. A hierarchical structure of openPCR is established according to Data Structure of Electronic Health Record Architecture and Data Standard of China (Chinese EHR Standard). Metadata attributes are grouped into six parts: identification, definition, representation, relation, usage guides, and administration. OpenPCR is an open metadata schema based on research registration standards, standards of the Clinical Data Interchange Standards Consortium (CDISC) and Chinese healthcare related standards, and is to be publicly available throughout China. It considers future integration of EHR and CR by adopting data structure and data terms in Chinese EHR Standard. Archetypes in openPCR are modularity models and can be separated, recombined, and reused. The authors recommend that the method to develop openPCR can be referenced by other countries when designing metadata schema of clinical research. In the next steps, openPCR should be used in a number of CR projects to test its applicability and to continuously improve its coverage. Besides, metadata schema for research protocol can be developed to structurize and standardize protocol, and syntactical interoperability of openPCR with other related standards can be considered.

Clinical-pathological findings of otitis media and media-interna in calves and (clinical) evaluation of a standardized therapeutic protocol.

PubMed

Bertone, I; Bellino, C; Alborali, G L; Cagnasso, A; Cagnotti, G; Dappiano, E; Lizzi, M; Miciletta, M; Ramacciotti, A; Gianella, P; D'Angelo, A

2015-12-03

The aims of this field trial were to describe the clinical-pathologic findings in calves with otitis media (OM) and media-interna (OMI), to evaluate, through the development of a scoring system, the effectiveness of a standardized therapeutic protocol, and to identify the causative pathogens and their possible correlation with concurrent respiratory disease. All animals underwent physical and neurological examinations at three experimental time points: at diagnosis/beginning of treatment (T0), 1 week (T1) and 2 weeks (T2) after therapy was started, respectively. Follow-up telephone interviews with animal owners were conducted 1 month later. The therapeutic protocol consisted of tulathromycin (Draxxin®; Zoetis), oxytetracycline hydrochloride (Terramicina 100®; Zoetis), and carprofen (Rimadyl®; Zoetis). Twenty-two calves were enrolled. Physical and otoscopic examination at T0 revealed monolateral and bilateral otorrhea in 16 and 6 calves, respectively, with peripheral vestibular system involvement in calves presenting with neurological signs (n = 17; 77 %). A significant improvement of clinical and neurological scores was observed in 20 (90 %) calves, a full recovery in only 1 (5 %). One calf worsened between T0 and T1 and it was removed from the study. None of the other animals showed a worsening of clinical conditions and/or required further treatments at one month follow up. Mycoplasma bovis was isolated in 89 % of the affected ears either alone or together with P. multocida (n = 5), Streptococcus spp. (n = 1), Staphylococcus spp. (n = 1), and Pseudomonas spp. (n = 1). M. bovis either alone or together with these bacteria was also isolated from the upper and/or lower respiratory tract in 19 (86 %) calves. This is the first prospective study to evaluate the effectiveness of a standardized therapeutic protocol for the treatment of OM/OMI in calves. The therapy led to clinical improvement in the majority of the calves. Persistence of mild clinical-neurological signs did not compromise productive performance. The numerical scoring system for clinical and neurological signs permitted objective evaluation of response to therapy. M. bovis was the pathogen most often isolated. This finding should be considered in the treatment of OM/OMI in calves. Moreover, respiratory tract infection should not be underrated, since it is one of the major risk factors for the development of OM/OMI.

Effect of initial shock wave voltage on shock wave lithotripsy-induced lesion size during step-wise voltage ramping.

PubMed

Connors, Bret A; Evan, Andrew P; Blomgren, Philip M; Handa, Rajash K; Willis, Lynn R; Gao, Sujuan

2009-01-01

To determine if the starting voltage in a step-wise ramping protocol for extracorporeal shock wave lithotripsy (SWL) alters the size of the renal lesion caused by the SWs. To address this question, one kidney from 19 juvenile pigs (aged 7-8 weeks) was treated in an unmodified Dornier HM-3 lithotripter (Dornier Medical Systems, Kennesaw, GA, USA) with either 2000 SWs at 24 kV (standard clinical treatment, 120 SWs/min), 100 SWs at 18 kV followed by 2000 SWs at 24 kV or 100 SWs at 24 kV followed by 2000 SWs at 24 kV. The latter protocols included a 3-4 min interval, between the 100 SWs and the 2000 SWs, used to check the targeting of the focal zone. The kidneys were removed at the end of the experiment so that lesion size could be determined by sectioning the entire kidney and quantifying the amount of haemorrhage in each slice. The average parenchymal lesion for each pig was then determined and a group mean was calculated. Kidneys that received the standard clinical treatment had a mean (sem) lesion size of 3.93 (1.29)% functional renal volume (FRV). The mean lesion size for the 18 kV ramping group was 0.09 (0.01)% FRV, while lesion size for the 24 kV ramping group was 0.51 (0.14)% FRV. The lesion size for both of these groups was significantly smaller than the lesion size in the standard clinical treatment group. The data suggest that initial voltage in a voltage-ramping protocol does not correlate with renal damage. While voltage ramping does reduce injury when compared with SWL with no voltage ramping, starting at low or high voltage produces lesions of the same approximate size. Our findings also suggest that the interval between the initial shocks and the clinical dose of SWs, in our one-step ramping protocol, is important for protecting the kidney against injury.

Development of a Protocol for Automated Glucose Measurement Transmission Used in Clinical Decision Support Systems Based on the Continua Design Guidelines.

PubMed

Meyer, Markus; Donsa, Klaus; Truskaller, Thomas; Frohner, Matthias; Pohn, Birgit; Felfernig, Alexander; Sinner, Frank; Pieber, Thomas

2018-01-01

A fast and accurate data transmission from glucose meter to clinical decision support systems (CDSSs) is crucial for the management of type 2 diabetes mellitus since almost all therapeutic interventions are derived from glucose measurements. Aim was to develop a prototype of an automated glucose measurement transmission protocol based on the Continua Design Guidelines and to embed the protocol into a CDSS used by healthcare professionals. A literature and market research was performed to analyze the state-of-the-art and thereupon develop, integrate and validate an automated glucose measurement transmission protocol in an iterative process. Findings from literature and market research guided towards the development of a standardized glucose measurement transmission protocol using a middleware. The interface description to communicate with the glucose meter was illustrated and embedded into a CDSS. A prototype of an interoperable transmission of glucose measurements was developed and implemented in a CDSS presenting a promising way to reduce medication errors and improve user satisfaction.

Multivoxel MR Spectroscopy in Acute Ischemic Stroke:Comparison to the Stroke Protocol MRI

PubMed Central

Dani, Krishna A.; An, Li; Henning, Erica C.; Shen, Jun; Warach, Steven

2014-01-01

Background and Purpose Few patients with stroke have been imaged with MR spectroscopy (MRS) within the first few hours after onset. We compared data from current MRI protocols to MRS in subjects with ischemic stroke. Methods MRS was incorporated into the standard clinical MRI stroke protocol for subjects <24 hours after onset. MRI and clinical correlates for the metabolic data from MRS were sought. Results One hundred thirty-six MRS voxels from 32 subjects were analyzed. Lactate preceded the appearance of the lesion on diffusion-weighted imaging in some voxels but in others lagged behind it. Current protocols may predict up to 41% of the variance of MRS metabolites. Serum glucose concentration and time to maximum partially predicted the concentration of all major metabolites. Conclusion MRS may be helpful in acute stroke, especially for lactate detection when perfusion-weighted imaging is unavailable. Current MRI protocols do provide surrogate markers for some indices of metabolic activity. PMID:23091121

Guidelines on Good Clinical Laboratory Practice

PubMed Central

Ezzelle, J.; Rodriguez-Chavez, I. R.; Darden, J. M.; Stirewalt, M.; Kunwar, N.; Hitchcock, R.; Walter, T.; D’Souza, M. P.

2008-01-01

A set of Good Clinical Laboratory Practice (GCLP) standards that embraces both the research and clinical aspects of GLP were developed utilizing a variety of collected regulatory and guidance material. We describe eleven core elements that constitute the GCLP standards with the objective of filling a gap for laboratory guidance, based on IND sponsor requirements, for conducting laboratory testing using specimens from human clinical trials. These GCLP standards provide guidance on implementing GLP requirements that are critical for laboratory operations, such as performance of protocol-mandated safety assays, peripheral blood mononuclear cell processing and immunological or endpoint assays from biological interventions on IND-registered clinical trials. The expectation is that compliance with the GCLP standards, monitored annually by external audits, will allow research and development laboratories to maintain data integrity and to provide immunogenicity, safety, and product efficacy data that is repeatable, reliable, auditable and that can be easily reconstructed in a research setting. PMID:18037599

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases.  CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR), Office of Regulatory Affairs for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Protocol Coordinator II: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials Provides deployment of clinical support services for clinical research Streamlines protocol development timeline Provides data and document collection and compilation for regulatory filing with the FDA and other regulatory authorities Provides administrative coordination and general logistical support for regulatory activities Ensures the provision of training for investigators and associate staff to reinforce and enhance a GCP culture Provides quality assurance and quality control oversight Performs regulatory review of clinical protocols, informed consent and other clinical documents Tracks and facilitates a portfolio of protocols through each process step (IRB, RAC, DSMB, Office of Protocol Services) Assists clinical investigators in preparing clinical research protocols, including writing and formatting protocol documents and consent forms Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies Collaborates with investigators to resolve any protocol/data issues Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI Institutional Review Board (IRB) and the clinical trial sponsor or the FDA Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events Attends and prepares minutes for the Branch Protocol Review Committees For protocols that are performed with other research centers: contacts coordinators at other centers to obtain review committee approvals at these centers, maintains records of these approvals at the outside centers in the protocol files, and sends protocol amendments and other reports to the participating centers Maintains a schedule of all review committee submission deadline dates and meeting dates Assists clinical investigators in understanding and complying with the entire review process Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document management and tracking system for NCI protocols Converts protocols from Word format to PDF with bookmarks Maintains the PDF version of the most current approved version of each active clinical protocol on a central server    This position has the option to be located in Frederick or Rockville, Maryland.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides comprehensive clinical and administrative support to the National Cancer Institute’s Center for Cancer Research’s (CCR) Protocol Support Office (PSO) for protocol development review, regulatory review, and the implementation process as well as oversees medical writing/editing, regulatory/ compliance, and protocol coordination/navigation and administration. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator III: Provides programmatic and logistical support for the operations of clinical research for Phase I and Phase II clinical trials. Provides deployment of clinical support services for clinical research. Streamlines the protocol development timeline. Provides data and documents collection and compilation for regulatory filing with the U.S. Food and Drug Administration (FDA) and other regulatory authorities.. Provides technical review and report preparation. Provides administrative coordination and general logistical support for regulatory activities. Ensures the provision of training for investigators and associate staff to reinforce and enhance a Good Clinical Practices (GCP) culture. Oversees quality assurance and quality control, performs regulatory review of clinical protocols, informed consent and other clinical documents. Tracks and facilitates a portfolio of protocols through each process step (Institutional Review Board [IRB], Regulatory Affairs Compliance [RAC], Data Safety Monitoring Board [DSMB], Office of Protocol Services). Assists clinical investigators in preparing clinical research protocols, including writing and formatting consent forms. Prepares protocol packages for review and ensures that protocol packages include all of the required material and comply with CCR, NCI and NIH policies. Collaborates with investigators to resolve any protocol/data issues. Coordinates submission of protocols for scientific and ethical review by the Branch scientific review committees, the NCI IRB, and the clinical trial sponsor or the FDA. Monitors the review process and maintains detailed, complete and accurate records for each protocol of the approvals at the various stages of the review process, including new protocol submissions, amendments to protocols, and continuing reviews, as well as other submissions such as adverse events. Attends and prepares minutes for the Branch Protocol Review Committees. Contacts coordinators at other centers for protocols that are performed there to obtain review committee approvals at those centers, maintains records of these approvals and sends protocol amendments and other reports to the participating centers. Maintains a schedule of all review committee submission deadline dates and meeting dates. Assists clinical investigators in understanding and complying with the entire review process. Works closely with the NCI Protocol Review Office in establishing and maintaining a paperless automated document and tracking system for NCI protocols. Converts protocols from Word format to .pdf with bookmarks. Maintains the .pdf version of the most current approved version of each active clinical protocol on a central server. This position is located in Rockville, Maryland.

Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects: The PROMOTE Study Protocol.

PubMed

Hensel, Kendi L; Carnes, Michael S; Stoll, Scott T

2016-11-01

The structural and physiologic changes in a woman's body during pregnancy can predispose pregnant women to low back pain and its associated disability, as well as to complications of pregnancy, labor, and delivery. Anecdotal and empirical evidence has indicated that osteopathic manipulative treatment (OMT) may be efficacious in improving pain and functionality in women who are pregnant. Based on that premise, the Pregnancy Research on Osteopathic Manipulation Optimizing Treatment Effects (PROMOTE) study was designed as a prospective, randomized, placebo-controlled, and blinded clinical trial to evaluate the efficacy of an OMT protocol for pain during third-trimester pregnancy. The OMT protocol developed for the PROMOTE study was based on physiologic theory and the concept of the interrelationship of structure and function. The 12 well-defined, standardized OMT techniques used in the protocol are commonly taught at osteopathic medical schools in the United States. These techniques can be easily replicated as a 20-minute protocol applied in conjunction with usual prenatal care, thus making it feasible to implement into clinical practice. This article presents an overview of the study design and treatment protocols used in the PROMOTE study.

SU-E-I-22: A Comprehensive Investigation of Noise Variations Between the GE Discovery CT750 HD and GE LightSpeed VCT

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

Bache, S; Loyer, E; Stauduhar, P

2015-06-15

Purpose: To quantify and compare the noise properties between two GE CT models-the Discovery CT750 HD (aka HD750) and LightSpeed VCT, with the overall goal of assessing the impact in clinical diagnostic practice. Methods: Daily QC data from a fleet of 9 CT scanners currently in clinical use were investigated – 5 HD750 and 4 VCT (over 600 total acquisitions for each scanner). A standard GE QC phantom was scanned daily using two sets of scan parameters with each scanner over 1 year. Water CT number and standard deviation were recorded from the image of water section of the QCmore » phantom. The standard GE QC scan parameters (Pitch = 0.516, 120kVp, 0.4s, 335mA, Small Body SFOV, 5mm thickness) and an in-house developed protocol (Axial, 120kVp, 1.0s, 240mA, Head SFOV, 5mm thickness) were used, with Standard reconstruction algorithm. Noise was measured as the standard deviation in the center of the water phantom image. Inter-model noise distributions and tube output in mR/mAs were compared to assess any relative differences in noise properties. Results: With the in-house protocols, average noise for the five HD750 scanners was ∼9% higher than the VCT scanners (5.8 vs 5.3). For the GE QC protocol, average noise with the HD750 scanners was ∼11% higher than with the VCT scanners (4.8 vs 4.3). This discrepancy in noise between the two models was found despite the tube output in mR/mAs being comparable with the HD750 scanners only having ∼4% lower output (8.0 vs 8.3 mR/mAs). Conclusion: Using identical scan protocols, average noise in images from the HD750 group was higher than that from the VCT group. This confirms feedback from an institutional radiologist’s feedback regarding grainier patient images from HD750 scanners. Further investigation is warranted to assess the noise texture and distribution, as well as clinical impact.« less

Establishment of a multidisciplinary concussion program: impact of standardization on patient care and resource utilization.

PubMed

Wilkins, Sara Anne; Shannon, Chevis N; Brown, Steven T; Vance, E Haley; Ferguson, Drew; Gran, Kimberly; Crowther, Marshall; Wellons, John C; Johnston, James M

2014-01-01

Recent legislation and media coverage have heightened awareness of concussion in youth sports. Previous work by the authors' group defined significant variation of care in management of children with concussion. To address this variation, a multidisciplinary concussion program was established based on a uniform management protocol, with emphasis on community outreach via traditional media sources and the Internet. This retrospective study evaluates the impact of standardization of concussion care and resource utilization before and after standardization in a large regional pediatric hospital center. This retrospective study included all patients younger than 18 years of age evaluated for sports-related concussion between January 1, 2007, and December 31, 2011. Emergency department, sports medicine, and neurosurgery records were reviewed. Data collected included demographics, injury details, clinical course, Sports Concussion Assessment Tool-2 (SCAT2) scores, imaging, discharge instructions, and referral for specialty care. The cohort was analyzed comparing patients evaluated before and after standardization of care. Five hundred eighty-nine patients were identified, including 270 before standardization (2007-2011) and 319 after standardization (2011-2012). Statistically significant differences (p < 0.0001) were observed between the 2 groups for multiple variables: there were more girls, more first-time concussions, fewer initial presentations to the emergency department, more consistent administration of the SCAT2, and more consistent supervision of return to play and return to think after adoption of the protocol. A combination of increased public awareness and legislation has led to a 5-fold increase in the number of youth athletes presenting for concussion evaluation at the authors' center. Establishment of a multidisciplinary clinic with a standardized protocol resulted in significantly decreased institutional resource utilization and more consistent concussion care for this growing patient population.

Design of the multicenter standardized supervised exercise training intervention for the claudication: exercise vs endoluminal revascularization (CLEVER) study.

PubMed

Bronas, Ulf G; Hirsch, Alan T; Murphy, Timothy; Badenhop, Dalynn; Collins, Tracie C; Ehrman, Jonathan K; Ershow, Abby G; Lewis, Beth; Treat-Jacobson, Diane J; Walsh, M Eileen; Oldenburg, Niki; Regensteiner, Judith G

2009-11-01

The CLaudication: Exercise Vs Endoluminal Revascularization (CLEVER) study is the first randomized, controlled, clinical, multicenter trial that is evaluating a supervised exercise program compared with revascularization procedures to treat claudication. In this report, the methods and dissemination techniques of the supervised exercise training intervention are described. A total of 217 participants are being recruited and randomized to one of three arms: (1) optimal medical care; (2) aortoiliac revascularization with stent; or (3) supervised exercise training. Of the enrolled patients, 84 will receive supervised exercise therapy. Supervised exercise will be administered according to a protocol designed by a central CLEVER exercise training committee based on validated methods previously used in single center randomized control trials. The protocol will be implemented at each site by an exercise committee member using training methods developed and standardized by the exercise training committee. The exercise training committee reviews progress and compliance with the protocol of each participant weekly. In conclusion, a multicenter approach to disseminate the supervised exercise training technique and to evaluate its efficacy, safety and cost-effectiveness for patients with claudication due to peripheral arterial disease (PAD) is being evaluated for the first time in CLEVER. The CLEVER study will further establish the role of supervised exercise training in the treatment of claudication resulting from PAD and provide standardized methods for use of supervised exercise training in future PAD clinical trials as well as in clinical practice.

Improving post-stroke dysphagia outcomes through a standardized and multidisciplinary protocol: an exploratory cohort study.

PubMed

Gandolfi, Marialuisa; Smania, Nicola; Bisoffi, Giulia; Squaquara, Teresa; Zuccher, Paola; Mazzucco, Sara

2014-12-01

Stroke is a major cause of dysphagia. Few studies to date have reported on standardized multidisciplinary protocolized approaches to the management of post-stroke dysphagia. The aim of this retrospective cohort study was to evaluate the impact of a standardized multidisciplinary protocol on clinical outcomes in patients with post-stroke dysphagia. We performed retrospective chart reviews of patients with post-stroke dysphagia admitted to the neurological ward of Verona University Hospital from 2004 to 2008. Outcomes after usual treatment for dysphagia (T- group) were compared versus outcomes after treatment under a standardized diagnostic and rehabilitative multidisciplinary protocol (T+ group). Outcome measures were death, pneumonia on X-ray, need for respiratory support, and proportion of patients on tube feeding at discharge. Of the 378 patients admitted with stroke, 84 had dysphagia and were enrolled in the study. A significantly lower risk of in-hospital death (odds ratio [OR] 0.20 [0.53-0.78]), pneumonia (OR 0.33 [0.10-1.03]), need for respiratory support (OR 0.48 [0.14-1.66]), and tube feeding at discharge (OR 0.30 [0.09-0.91]) was recorded for the T+ group (N = 39) as compared to the T- group (N = 45). The adjusted OR showed no difference between the two groups for in-hospital death and tube feeding at discharge. Use of a standardized multidisciplinary protocolized approach to the management of post-stroke dysphagia may significantly reduce rates of aspiration pneumonia, in-hospital mortality, and tube feeding in dysphagic stroke survivors. Consistent with the study's exploratory purposes, our findings suggest that the multidisciplinary protocol applied in this study offers an effective model of management of post-stroke dysphagia.

Perceptions of Massage Therapists Participating in a Randomized Controlled Trial

PubMed Central

Perlman, Adam; Dreusicke, Mark; Keever, Teresa; Ali, Ather

2015-01-01

Background Clinical practice and randomized trials often have disparate aims, despite involving similar interventions. Attitudes and expectancies of practitioners influence patient outcomes, and there is growing emphasis on optimizing provider–patient relationships. In this study, we evaluated the experiences of licensed massage therapists involved in a randomized controlled clinical trial using qualitative methodology. Methods Seven massage therapists who were interventionists in a randomized controlled trial participated in structured interviews approximately 30 minutes in length. Interviews focused on their experiences and perceptions regarding aspects of the clinical trial, as well as recommendations for future trials. Transcribed interviews were analyzed for emergent topics and themes using standard qualitative methods. Results Six themes emerged. Therapists discussed 1) promoting the profession of massage therapy through research, 2) mixed views on using standardized protocols, 3) challenges of sham interventions, 4) participant response to the sham intervention, 5) views on scheduling and compensation, and 6) unanticipated benefits of participating in research. Conclusions Therapists largely appreciated the opportunity to promote massage through research. They demonstrated insight and understanding of the rationale for a clinical trial adhering to a standardized protocol. Evaluating the experiences and ideas of complementary and alternative medicine practitioners provides valuable insight that is relevant for the implementation and design of randomized trials. PMID:26388961

Implementing a Standardized Social Networks Testing Strategy in a Low HIV Prevalence Jurisdiction.

PubMed

Schumann, Casey; Kahn, Danielle; Broaddus, Michelle; Dougherty, Jacob; Elderbrook, Megan; Vergeront, James; Westergaard, Ryan

2018-05-15

Alternative HIV testing strategies are needed to engage individuals not reached by traditional clinical or non-clinical testing programs. A social networks recruitment strategy, in which people at risk for or living with HIV are enlisted and trained by community-based agencies to recruit individuals from their social, sexual, or drug-using networks for HIV testing, demonstrates higher positivity rates compared to other non-clinical recruitment strategies in some jurisdictions. During 2013-2015, a social networks testing protocol was implemented in Wisconsin to standardize an existing social networks testing program. Six community-based, non-clinical agencies with multiple sites throughout the state implemented the protocol over the 2-year period. Both quantitative and qualitative data were collected. The new positivity rate (0.49%) through social networks testing did not differ from that of traditional counseling, testing, and referral recruitment methods (0.48%). Although social networks testing did not yield a higher new positivity rate compared to other testing strategies, it proved to be successful at reaching high risk individuals who may not otherwise engage in HIV testing.

MRI of penile fracture: what should be a tailored protocol in emergency?

PubMed

Esposito, Andrea Alessandro; Giannitto, Caterina; Muzzupappa, Claudia; Maccagnoni, Sara; Gadda, Franco; Albo, Giancarlo; Biondetti, Pietro Raimondo

2016-09-01

To conduct a review of literature to summarize the existing MRI protocols for penile trauma, suggesting a tailored protocol to reduce costs and time of examination. A systematic search was performed in Medline, Embase, Cochrane Library, and Cinahl databases from 1995 to 2015 to identify studies evaluating penis trauma with MRI examination. Studies were included if there was the description of MRI protocol with at least sequences and orthogonal planes used. We chose a systematic approach for data extraction and descriptive synthesis. 12 articles were included in our study. Among the list of 12 articles: 2 were case reports, 3 were clinical series, and 7 were reviews. Clinical trials were not found. There is no unanimous consensus among the authors. Summarizing the data, the most used protocol is characterized by T2 sequences in three orthogonal planes plus T1 sequences in one plane (either axial or sagittal) without contrast medium injection. There is a lack of a standard protocol. A tailored protocol to answer the diagnostic question, reducing costs and time of examination, is characterized by T2 sequences in three orthogonal planes plus at least a T1 sequence (either axial or sagittal plane).

Application of EARL (ResEARch 4 Life®) protocols for [18F]FDG-PET/CT clinical and research studies. A roadmap towards exact recovery coefficient

NASA Astrophysics Data System (ADS)

Balcerzyk, Marcin; Fernández-López, Rosa; Parrado-Gallego, Ángel; Pachón-Garrudo, Víctor Manuel; Chavero-Royan, José; Hevilla, Juan; Jiménez-Ortega, Elisa; Leal, Antonio

2017-11-01

Tumour uptake value is a critical result in [18F]FDG-PET/CT ([18F]fluorodeoxyglucose) quantitative scans such as the dose prescription for radiotherapy and oncology. The quantification is highly dependent on the protocol of acquisition and reconstruction of the image, especially in low activity tumours. During adjusting acquisition and reconstruction protocols available in our Siemens Biograph mCT scanner for EARL (ResEARch 4 Life®) [18F]FDG-PET/CT accreditation requirements, we developed reconstruction protocols which will be used in PET based radiotherapy planning able to reduce inter-/intra-institute variability in Standard Uptake Value (SUV) results, and to bring Recovery Coefficient to 1 as close as possible for Image Quality NEMA 2007 phantom. Primary and secondary tumours from two patients were assessed by four independent evaluators. The influence of reconstruction protocols on tumour clinical assessment was presented. We proposed the improvement route for EARL accredited protocols so that they may be developed in classes to take advantage of scanner possibilities. The application of optimized reconstruction protocol eliminates the need of partial volume corrections.

Benchmarking pediatric cranial CT protocols using a dose tracking software system: a multicenter study.

PubMed

De Bondt, Timo; Mulkens, Tom; Zanca, Federica; Pyfferoen, Lotte; Casselman, Jan W; Parizel, Paul M

2017-02-01

To benchmark regional standard practice for paediatric cranial CT-procedures in terms of radiation dose and acquisition parameters. Paediatric cranial CT-data were retrospectively collected during a 1-year period, in 3 different hospitals of the same country. A dose tracking system was used to automatically gather information. Dose (CTDI and DLP), scan length, amount of retakes and demographic data were stratified by age and clinical indication; appropriate use of child-specific protocols was assessed. In total, 296 paediatric cranial CT-procedures were collected. Although the median dose of each hospital was below national and international diagnostic reference level (DRL) for all age categories, statistically significant (p-value < 0.001) dose differences among hospitals were observed. The hospital with lowest dose levels showed smallest dose variability and used age-stratified protocols for standardizing paediatric head exams. Erroneous selection of adult protocols for children still occurred, mostly in the oldest age-group. Even though all hospitals complied with national and international DRLs, dose tracking and benchmarking showed that further dose optimization and standardization is possible by using age-stratified protocols for paediatric cranial CT. Moreover, having a dose tracking system revealed that adult protocols are still applied for paediatric CT, a practice that must be avoided. • Significant differences were observed in the delivered dose between age-groups and hospitals. • Using age-adapted scanning protocols gives a nearly linear dose increase. • Sharing dose-data can be a trigger for hospitals to reduce dose levels.

Optimization and validation of sample preparation for metagenomic sequencing of viruses in clinical samples.

PubMed

Lewandowska, Dagmara W; Zagordi, Osvaldo; Geissberger, Fabienne-Desirée; Kufner, Verena; Schmutz, Stefan; Böni, Jürg; Metzner, Karin J; Trkola, Alexandra; Huber, Michael

2017-08-08

Sequence-specific PCR is the most common approach for virus identification in diagnostic laboratories. However, as specific PCR only detects pre-defined targets, novel virus strains or viruses not included in routine test panels will be missed. Recently, advances in high-throughput sequencing allow for virus-sequence-independent identification of entire virus populations in clinical samples, yet standardized protocols are needed to allow broad application in clinical diagnostics. Here, we describe a comprehensive sample preparation protocol for high-throughput metagenomic virus sequencing using random amplification of total nucleic acids from clinical samples. In order to optimize metagenomic sequencing for application in virus diagnostics, we tested different enrichment and amplification procedures on plasma samples spiked with RNA and DNA viruses. A protocol including filtration, nuclease digestion, and random amplification of RNA and DNA in separate reactions provided the best results, allowing reliable recovery of viral genomes and a good correlation of the relative number of sequencing reads with the virus input. We further validated our method by sequencing a multiplexed viral pathogen reagent containing a range of human viruses from different virus families. Our method proved successful in detecting the majority of the included viruses with high read numbers and compared well to other protocols in the field validated against the same reference reagent. Our sequencing protocol does work not only with plasma but also with other clinical samples such as urine and throat swabs. The workflow for virus metagenomic sequencing that we established proved successful in detecting a variety of viruses in different clinical samples. Our protocol supplements existing virus-specific detection strategies providing opportunities to identify atypical and novel viruses commonly not accounted for in routine diagnostic panels.

Standardization of a Videofluoroscopic Swallow Study Protocol to Investigate Dysphagia in Dogs.

PubMed

Harris, R A; Grobman, M E; Allen, M J; Schachtel, J; Rawson, N E; Bennett, B; Ledyayev, J; Hopewell, B; Coates, J R; Reinero, C R; Lever, T E

2017-03-01

Videofluoroscopic swallow study (VFSS) is the gold standard for diagnosis of dysphagia in veterinary medicine but lacks standardized protocols that emulate physiologic feeding practices. Age impacts swallow function in humans but has not been evaluated by VFSS in dogs. To develop a protocol with custom kennels designed to allow free-feeding of 3 optimized formulations of contrast media and diets that address limitations of current VFSS protocols. We hypothesized that dogs evaluated by a free-feeding VFSS protocol would show differences in objective swallow metrics based on age. Healthy juvenile, adult, and geriatric dogs (n = 24). Prospective, experimental study. Custom kennels were developed to maintain natural feeding behaviors during VFSS. Three food consistencies (thin liquid, pureed food, and dry kibble) were formulated with either iohexol or barium to maximize palatability and voluntary prehension. Dogs were evaluated by 16 swallow metrics and compared across age groups. Development of a standardized VFSS protocol resulted in successful collection of swallow data in healthy dogs. No significant differences in swallow metrics were observed among age groups. Substantial variability was observed in healthy dogs when evaluated under these physiologic conditions. Features typically attributed to pathologic states, such as gastric reflux, were seen in healthy dogs. Development of a VFSS protocol that reflects natural feeding practices may allow emulation of physiology resulting in clinical signs of dysphagia. Age did not result in significant changes in swallow metrics, but additional studies are needed, particularly in light of substantial normal variation. Copyright © 2017 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Comparison between TG-51 and TG-21: Calibration of photon and electron beams in water using cylindrical chambers.

PubMed

Cho, S H; Lowenstein, J R; Balter, P A; Wells, N H; Hanson, W F

2000-01-01

A new calibration protocol, developed by the AAPM Task Group 51 (TG-51) to replace the TG-21 protocol, is based on an absorbed-dose to water standard and calibration factor (N(D,w)), while the TG-21 protocol is based on an exposure (or air-kerma) standard and calibration factor (N(x)). Because of differences between these standards and the two protocols, the results of clinical reference dosimetry based on TG-51 may be somewhat different from those based on TG-21. The Radiological Physics Center has conducted a systematic comparison between the two protocols, in which photon and electron beam outputs following both protocols were compared under identical conditions. Cylindrical chambers used in this study were selected from the list given in the TG-51 report, covering the majority of current manufacturers. Measured ratios between absorbed-dose and air-kerma calibration factors, derived from the standards traceable to the NIST, were compared with calculated values using the TG-21 protocol. The comparison suggests that there is roughly a 1% discrepancy between measured and calculated ratios. This discrepancy may provide a reasonable measure of possible changes between the absorbed-dose to water determined by TG-51 and that determined by TG-21 for photon beam calibrations. The typical change in a 6 MV photon beam calibration following the implementation of the TG-51 protocol was about 1%, regardless of the chamber used, and the change was somewhat smaller for an 18 MV photon beam. On the other hand, the results for 9 and 16 MeV electron beams show larger changes up to 2%, perhaps because of the updated electron stopping power data used for the TG-51 protocol, in addition to the inherent 1% discrepancy presented in the calibration factors. The results also indicate that the changes may be dependent on the electron energy.

Evaluation of Dogs with Border Collie Collapse, Including Response to Two Standardized Strenuous Exercise Protocols.

PubMed

Taylor, Susan; Shmon, Cindy; Su, Lillian; Epp, Tasha; Minor, Katie; Mickelson, James; Patterson, Edward; Shelton, G Diane

2016-01-01

Clinical and metabolic variables were evaluated in 13 dogs with border collie collapse (BCC) before, during, and following completion of standardized strenuous exercise protocols. Six dogs participated in a ball-retrieving protocol, and seven dogs participated in a sheep-herding protocol. Findings were compared with 16 normal border collies participating in the same exercise protocols (11 retrieving, five herding). Twelve dogs with BCC developed abnormal mentation and/or an abnormal gait during evaluation. All dogs had post-exercise elevations in rectal temperature, pulse rate, arterial blood pH, PaO2, and lactate, and decreased PaCO2 and bicarbonate, as expected with strenuous exercise, but there were no significant differences between BCC dogs and normal dogs. Electrocardiography demonstrated sinus tachycardia in all dogs following exercise. Needle electromyography was normal, and evaluation of muscle biopsy cryosections using a standard panel of histochemical stains and reactions did not reveal a reason for collapse in 10 dogs with BCC in which these tests were performed. Genetic testing excluded the dynamin-1 related exercise-induced collapse mutation and the V547A malignant hyperthermia mutation as the cause of BCC. Common reasons for exercise intolerance were eliminated. Although a genetic basis is suspected, the cause of collapse in BCC was not determined.

From Expert Protocols to Standardized Management of Infectious Diseases.

PubMed

Lagier, Jean-Christophe; Aubry, Camille; Delord, Marion; Michelet, Pierre; Tissot-Dupont, Hervé; Million, Matthieu; Brouqui, Philippe; Raoult, Didier; Parola, Philippe

2017-08-15

We report here 4 examples of management of infectious diseases (IDs) at the University Hospital Institute Méditerranée Infection in Marseille, France, to illustrate the value of expert protocols feeding standardized management of IDs. First, we describe our experience on Q fever and Tropheryma whipplei infection management based on in vitro data and clinical outcome. Second, we describe our management-based approach for the treatment of infective endocarditis, leading to a strong reduction of mortality rate. Third, we report our use of fecal microbiota transplantation to face severe Clostridium difficile infections and to perform decolonization of patients colonized by emerging highly resistant bacteria. Finally, we present the standardized management of the main acute infections in patients admitted in the emergency department, promoting antibiotics by oral route, checking compliance with the protocol, and avoiding the unnecessary use of intravenous and urinary tract catheters. Overall, the standardization of the management is the keystone to reduce both mortality and morbidity related to IDs. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

The effect of personalized versus standard patient protocols for radiostereometric analysis (RSA).

PubMed

Muharemovic, O; Troelsen, A; Thomsen, M G; Kallemose, T; Gosvig, K K

2018-05-01

Increasing pressure in the clinic requires a more standardized approach to radiostereometric analysis (RSA) imaging. The aim of this study was to investigate whether implementation of personalized RSA patient protocols could increase image quality and decrease examination time and the number of exposure repetitions. Forty patients undergoing primary total hip arthroplasty were equally randomized to either a case or a control group. Radiographers in the case group were assisted by personalized patient protocols containing information about each patient's post-operative RSA imaging. Radiographers in the control group used a standard RSA protocol. At three months, radiographers in the case group significantly reduced (p < 0.001) the number of exposures by 1.6, examination time with 19.2 min, and distance between centrum of prosthesis and centrum of calibration field with 34.1 mm when compared to post-operative (baseline) results. At twelve months, the case group significantly reduced (p < 0.001) number of exposures by two, examination time with 22.5 min, and centrum of prosthesis to centrum of calibration field distance with 43.1 mm when compared to baseline results. No significant improvements were found in the control group at any time point. There is strong evidence that personalized RSA patient protocols have a positive effect on image quality and radiation dose savings. Implementation of personal patient protocols as a RSA standard will contribute to the reduction of examination time, thus ensuring a cost benefit for department and patient safety. Copyright © 2017 The College of Radiographers. Published by Elsevier Ltd. All rights reserved.

Frequency of "Pocket" Hematoma in Patients Receiving Vitamin K Antagonist and Antiplatelet Therapy at the Time of Pacemaker or Cardioverter Defibrillator Implantation (from the POCKET Study).

PubMed

Malagù, Michele; Trevisan, Filippo; Scalone, Antonella; Marcantoni, Lina; Sammarco, Giuseppe; Bertini, Matteo

2017-04-01

In patients undergoing cardiac device implantation, anticoagulant and antiplatelet therapy are associated with an increased risk of pocket hematoma. In case of vitamin K antagonist therapy, a strategy of continued warfarin with no heparin bridge showed a reduction of pocket hematoma. Evidence regarding antiplatelet therapy management is limited. This is a single-center observational study which reflects our systematic approach to the problem. In 2012, we proposed an improved management protocol for anticoagulant and antiplatelet therapy (no-bridge protocol) based on individual thromboembolic risk stratification, noninterruption of oral anticoagulation, no bridge with heparin and elastic adherence compression bandage. The primary end point was the incidence of clinically significant pocket hematoma in the first 30 days after implantation. A total of 1,035 patients were enrolled, of whom 522 received the standard management and 513 the new protocol. The primary end point occurred in 34 patients of the standard management group and 8 patients of the no-bridge protocol group (6.5% vs 1.6%, p <0.001). Patients in the standard management group had a higher incidence of pocket infections (2.3% vs 0.6%, p = 0.02), lead dislodgements (4.8% vs 2.1%, p = 0.02), and thromboembolic events (1.3% vs 0.0%, p <0.01). On a multivariate analysis, heparin and coronary artery disease were independent predictors of pocket hematoma (relative risk [RR] 3.48, 95% confidence interval [CI] 1.55 to 7.83 and RR 2.43, 95% CI 1.25 to 4.76, respectively), whereas the no-bridge protocol was associated with a reduction of pocket hematoma (RR 0.33, 95% CI 0.14 to 0.76). New anticoagulant and antiplatelet therapy management protocol was associated with a reduced incidence of clinically significant pocket hematomas, thromboembolic events, pocket infections, and lead dislodgements. Copyright © 2017 Elsevier Inc. All rights reserved.

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols.

PubMed

Reveiz, Ludovic; Haby, Michelle M; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E; Elias, Vanessa; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D

2017-01-01

Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV.

Standardization and quantification in FDG-PET/CT imaging for staging and restaging of malignant disease.

PubMed

Gámez-Cenzano, Cristina; Pino-Sorroche, Francisco

2014-04-01

There is a growing interest in using quantification in FDG-PET/CT in oncology, especially for evaluating response to therapy. Complex full quantitative procedures with blood sampling and dynamic scanning have been clinically replaced by the use of standardized uptake value measurements that provide an index of regional tracer uptake normalized to the administered dose of FDG. Some approaches have been proposed for assessing quantitative metabolic response, such as EORTC and PERCIST criteria in solid tumors. When using standardized uptake value in clinical routine and multicenter trials, standardization of protocols and quality control procedures of instrumentation is required. Copyright © 2014 Elsevier Inc. All rights reserved.

Brachial plexus assessment with three-dimensional isotropic resolution fast spin echo MRI: comparison with conventional MRI at 3.0 T

PubMed Central

Tagliafico, A; Succio, G; Neumaier, C E; Baio, G; Serafini, G; Ghidara, M; Calabrese, M; Martinoli, C

2012-01-01

Objective The purpose of our study was to determine whether a three-dimensional (3D) isotropic resolution fast spin echo sequence (FSE-cube) has similar image quality and diagnostic performance to a routine MRI protocol for brachial plexus evaluation in volunteers and symptomatic patients at 3.0 T. Institutional review board approval and written informed consent were guaranteed. Methods In this prospective study FSE-cube was added to the standard brachial plexus examination protocol in eight patients (mean age, 50.2 years) with brachial plexus pathologies and in six volunteers (mean age, 54 years). Nerve visibility, tissue contrast, edge sharpness, image blurring, motion artefact and acquisition time were calculated for FSE-cube sequences and for the standard protocol on a standardised five-point scale. The visibility of brachial plexus nerve and surrounding tissues at four levels (roots, interscalene area, costoclavicular space and axillary level) was assessed. Results Image quality and nerve visibility did not significantly differ between FSE-cube and the standard protocol (p>0.05). Acquisition time was statistically and clinically significantly shorter with FSE-cube (p<0.05). Pathological findings were seen equally well with FSE-cube and the standard protocol. Conclusion 3D FSE-cube provided similar image quality in a shorter acquisition time and enabled excellent visualisation of brachial plexus anatomy and pathology in any orientation, regardless of the original scanning plane. PMID:21343321

INTERGROWTH-21st Gestational Dating and Fetal and Newborn Growth Standards in Peri-Urban Nairobi, Kenya: Quasi-Experimental Implementation Study Protocol.

PubMed

Millar, Kathryn; Patel, Suha; Munson, Meghan; Vesel, Linda; Subbiah, Shalini; Jones, Rachel M; Little, Sarah; Papageorghiou, Aris T; Villar, Jose; Wegner, Mary Nell; Pearson, Nick; Muigai, Faith; Ongeti, Catherine; Langer, Ana

2018-06-22

The burden of preterm birth, fetal growth impairment, and associated neonatal deaths disproportionately falls on low- and middle-income countries where modern obstetric tools are not available to date pregnancies and monitor fetal growth accurately. The INTERGROWTH-21 st gestational dating, fetal growth monitoring, and newborn size at birth standards make this possible. To scale up the INTERGROWTH-21 st standards, it is essential to assess the feasibility and acceptability of their implementation and their effect on clinical decision-making in a low-resource clinical setting. This study protocol describes a pre-post, quasi-experimental implementation study of the standards at Jacaranda Health, a maternity hospital in peri-urban Nairobi, Kenya. All women with viable fetuses receiving antenatal and delivery services, their resulting newborns, and the clinicians caring for them from March 2016 to March 2018 are included. The study comprises a 12-month preimplementation phase, a 12-month implementation phase, and a 5-month post-implementation phase to be completed in August 2018. Quantitative clinical and qualitative data collected during the preimplementation and implementation phases will be assessed. A clinician survey was administered eight months into the implementation phase, month 20 of the study. Implementation outcomes include quantitative and qualitative analyses of feasibility, acceptability, adoption, appropriateness, fidelity, and penetration of the standards. Clinical outcomes include appropriateness of referral and effect of the standards on clinical care and decision-making. Descriptive analyses will be conducted, and comparisons will be made between pre- and postimplementation outcomes. Qualitative data will be analyzed using thematic coding and compared across time. The study was approved by the Amref Ethics and Scientific Review Committee (Kenya) and the Harvard University Institutional Review Board. Study results will be shared with stakeholders through conferences, seminars, publications, and knowledge management platforms. From October 2016 to February 2017, over 90% of all full-time Jacaranda clinicians (26/28) received at least one of the three aspects of the INTERGROWTH-21 st training: gestational dating ultrasound, fetal growth monitoring ultrasound, and neonatal anthropometry standards. Following the training, implementation and evaluation of the standards in Jacaranda Health's clinical workflow will take place from March 2017 through March 5, 2018. Data analysis will be finalized, and results will be shared by August 2018. The findings of this study will have major implications on the national and global scale up of the INTERGROWTH-21 st standards and on the process of scaling up global standards in general, particularly in limited-resource settings. RR1-10.2196/10293. ©Kathryn Millar, Suha Patel, Meghan Munson, Linda Vesel, Shalini Subbiah, Rachel M. Jones, Sarah Little, Aris T. Papageorghiou, Jose Villar, Mary Nell Wegner, Nick Pearson, Faith Muigai, Catherine Ongeti, Ana Langer. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.06.2018.

Computer simulation of fibrillation threshold measurements and electrophysiologic testing procedures

NASA Technical Reports Server (NTRS)

Grumbach, M. P.; Saxberg, B. E.; Cohen, R. J.

1987-01-01

A finite element model of cardiac conduction was used to simulate two experimental protocols: 1) fibrillation threshold measurements and 2) clinical electrophysiologic (EP) testing procedures. The model consisted of a cylindrical lattice whose properties were determined by four parameters: element length, conduction velocity, mean refractory period, and standard deviation of refractory periods. Different stimulation patterns were applied to the lattice under a given set of lattice parameter values and the response of the model was observed through a simulated electrocardiogram. The studies confirm that the model can account for observations made in experimental fibrillation threshold measurements and in clinical EP testing protocols.

A GMP-compliant protocol to expand and transfect cancer patient T cells with mRNA encoding a tumor-specific chimeric antigen receptor.

PubMed

Krug, Christian; Wiesinger, Manuel; Abken, Hinrich; Schuler-Thurner, Beatrice; Schuler, Gerold; Dörrie, Jan; Schaft, Niels

2014-10-01

Chimeric antigen receptors (CARs), which combine an antibody-derived binding domain (single chain fragment variable) with T-cell-activating signaling domains, have become a promising tool in the adoptive cellular therapy of cancer. Retro- and lenti-viral transductions are currently the standard methods to equip T cells with a CAR; permanent CAR expression, however, harbors several risks like uncontrolled auto-reactivity. Modification of T cells by electroporation with CAR-encoding RNA to achieve transient expression likely circumvents these difficulties. We here present a GMP-compliant protocol to activate and expand T cells for clinical application. The protocol is optimized in particular to produce CAR-modified T cells in clinically sufficient numbers under full GMP-compliance from late-stage cancer patients. This protocol allows the generation of 6.7 × 10(8) CAR-expressing T cells from one patient leukapheresis. The CAR-engineered T cells produced pro-inflammatory cytokines after stimulation with antigen-bearing tumor cells and lysed tumor cells in an antigen-specific manner. This functional capacity was maintained after cryopreservation. Taken together, we provide a clinically applicable protocol to transiently engineer sufficient numbers of antigen-specific patient T cells for use in adoptive cell therapy of cancer.

Security architecture for HL/7 message interchange.

PubMed

Chen, T S; Liao, B S; Lin, M G; Gough, T G

2001-01-01

The promotion of quality medical treatment is very important to the healthcare providers as well as to patients. It requires that the medical resources of different hospitals be combined to ensure that medical information is shared and that resources are not wasted. A computer-based patient record is one of the best methods to accomplish the interchange of the patient's clinical data. In our system, the Health Level/Seven (HL/7) format is used for the interchange of the clinical data, as it has been supported by many healthcare providers and become a â standard'. The security of the interchange of clinical data is a serious issue for people using the Internet for data communication. Several international well-developed security algorithms, models and secure policies are adopted in the design of a security handler for an HL/7 architecture. The goal of our system is to combine our security system with the end-to-end communication systems constructed from the HL/7 format to establish a safe delivery channel. A suitable security interchange environment is implemented to address some shortcomings in clinical data interchange. located at the application layer of the ISO/OSI reference model. The medical message components, sub-components, and related types of message event are the primary goals of the HL/7 protocols. The patient management system, the doctor's system for recording his advice, examination and diagnosis as well as any financial management system are all covered by the HL/7 protocols. Healthcare providers and hospitals in Taiwan are very interested in developing the HL/7 protocols as a common standard for clinical data interchange.

Guidelines for Inclusion of Patient-Reported Outcomes in Clinical Trial Protocols: The SPIRIT-PRO Extension.

PubMed

Calvert, Melanie; Kyte, Derek; Mercieca-Bebber, Rebecca; Slade, Anita; Chan, An-Wen; King, Madeleine T; Hunn, Amanda; Bottomley, Andrew; Regnault, Antoine; Chan, An-Wen; Ells, Carolyn; O'Connor, Daniel; Revicki, Dennis; Patrick, Donald; Altman, Doug; Basch, Ethan; Velikova, Galina; Price, Gary; Draper, Heather; Blazeby, Jane; Scott, Jane; Coast, Joanna; Norquist, Josephine; Brown, Julia; Haywood, Kirstie; Johnson, Laura Lee; Campbell, Lisa; Frank, Lori; von Hildebrand, Maria; Brundage, Michael; Palmer, Michael; Kluetz, Paul; Stephens, Richard; Golub, Robert M; Mitchell, Sandra; Groves, Trish

2018-02-06

Patient-reported outcome (PRO) data from clinical trials can provide valuable evidence to inform shared decision making, labeling claims, clinical guidelines, and health policy; however, the PRO content of clinical trial protocols is often suboptimal. The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) statement was published in 2013 and aims to improve the completeness of trial protocols by providing evidence-based recommendations for the minimum set of items to be addressed, but it does not provide PRO-specific guidance. To develop international, consensus-based, PRO-specific protocol guidance (the SPIRIT-PRO Extension). The SPIRIT-PRO Extension was developed following the Enhancing Quality and Transparency of Health Research (EQUATOR) Network's methodological framework for guideline development. This included (1) a systematic review of existing PRO-specific protocol guidance to generate a list of potential PRO-specific protocol items (published in 2014); (2) refinements to the list and removal of duplicate items by the International Society for Quality of Life Research (ISOQOL) Protocol Checklist Taskforce; (3) an international stakeholder survey of clinical trial research personnel, PRO methodologists, health economists, psychometricians, patient advocates, funders, industry representatives, journal editors, policy makers, ethicists, and researchers responsible for evidence synthesis (distributed by 38 international partner organizations in October 2016); (4) an international Delphi exercise (n = 137 invited; October 2016 to February 2017); and (5) consensus meeting (n = 30 invited; May 2017). Prior to voting, consensus meeting participants were informed of the results of the Delphi exercise and given data from structured reviews evaluating the PRO protocol content of 3 defined samples of trial protocols. The systematic review identified 162 PRO-specific protocol recommendations from 54 sources. The ISOQOL Taskforce (n = 21) reduced this to 56 items, which were considered by 138 international stakeholder survey participants and 99 Delphi panelists. The final wording of the SPIRIT-PRO Extension was agreed on at a consensus meeting (n = 29 participants) and reviewed by external group of experts during a consultation period. Eleven extensions and 5 elaborations to the SPIRIT 2013 checklist were recommended for inclusion in clinical trial protocols in which PROs are a primary or key secondary outcome. Extension items focused on PRO-specific issues relating to the trial rationale, objectives, eligibility criteria, concepts used to evaluate the intervention, time points for assessment, PRO instrument selection and measurement properties, data collection plan, translation to other languages, proxy completion, strategies to minimize missing data, and whether PRO data will be monitored during the study to inform clinical care. The SPIRIT-PRO guidelines provide recommendations for items that should be addressed and included in clinical trial protocols in which PROs are a primary or key secondary outcome. Improved design of clinical trials including PROs could help ensure high-quality data that may inform patient-centered care.

A CAD system and quality assurance protocol for bone age assessment utilizing digital hand atlas

NASA Astrophysics Data System (ADS)

Gertych, Arakadiusz; Zhang, Aifeng; Ferrara, Benjamin; Liu, Brent J.

2007-03-01

Determination of bone age assessment (BAA) in pediatric radiology is a task based on detailed analysis of patient's left hand X-ray. The current standard utilized in clinical practice relies on a subjective comparison of the hand with patterns in the book atlas. The computerized approach to BAA (CBAA) utilizes automatic analysis of the regions of interest in the hand image. This procedure is followed by extraction of quantitative features sensitive to skeletal development that are further converted to a bone age value utilizing knowledge from the digital hand atlas (DHA). This also allows providing BAA results resembling current clinical approach. All developed methodologies have been combined into one CAD module with a graphical user interface (GUI). CBAA can also improve the statistical and analytical accuracy based on a clinical work-flow analysis. For this purpose a quality assurance protocol (QAP) has been developed. Implementation of the QAP helped to make the CAD more robust and find images that cannot meet conditions required by DHA standards. Moreover, the entire CAD-DHA system may gain further benefits if clinical acquisition protocol is modified. The goal of this study is to present the performance improvement of the overall CAD-DHA system with QAP and the comparison of the CAD results with chronological age of 1390 normal subjects from the DHA. The CAD workstation can process images from local image database or from a PACS server.

Electronic decision protocols for ART patient triaging to expand access to HIV treatment in South Africa: a cross sectional study for development and validation.

PubMed

Mitchell, Marc; Hedt, Bethany L; Eshun-Wilson, Ingrid; Fraser, Hamish; John, Melanie-Anne; Menezes, Colin; Grobusch, Martin P; Jackson, Jonathan; Taljaard, Jantjie; Lesh, Neal

2012-03-01

The shortage of doctors and nurses, along with future expansion into rural clinics, will require that the majority of clinic visits by HIV infected patients on antiretroviral therapy (ART) are managed by non-doctors. The goal of this study was to develop and evaluate a screening protocol to determine which patients needed a full clinical assessment and which patients were stable enough to receive their medications without a doctor's consultation. For this study, we developed an electronic, handheld tool to guide non-physician counselors through screening questions. Patients visiting two ART clinics in South Africa for routine follow-up visits between March 2007 and April 2008 were included in our study. Each patient was screened by non-physician counselors using the handheld device and then received a full clinical assessment. Clinicians' report on whether full clinical assessment had been necessary was used as the gold standard for determining "required referral". Observations were randomly divided into two datasets--989 for developing a referral protocol and 200 for validating protocol performance. A third of patients had at least one physical complaint, and 16% had five or more physical complaints. 38% of patients required referral for full clinical assessment. We identify a subset of questions which are 87% sensitive and 47% specific for recommended patient referral. The final screening protocol is highly sensitive and could reduce burden on ART clinicians by 30%. The uptake and acceptance of the handheld tool to support implementation of the protocol was high. Further examination of the data reveals several important questions to include in future referral algorithms to improve sensitivity and specificity. Based on these results, we identify a refined algorithm to explore in future evaluations. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Inconsistencies in quality of life data collection in clinical trials: a potential source of bias? Interviews with research nurses and trialists.

PubMed

Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

2013-01-01

Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection.

Inconsistencies in Quality of Life Data Collection in Clinical Trials: A Potential Source of Bias? Interviews with Research Nurses and Trialists

PubMed Central

Kyte, Derek; Ives, Jonathan; Draper, Heather; Keeley, Thomas; Calvert, Melanie

2013-01-01

Background Patient-reported outcomes (PROs), such as health-related quality of life (HRQL) are increasingly used to evaluate treatment effectiveness in clinical trials, are valued by patients, and may inform important decisions in the clinical setting. It is of concern, therefore, that preliminary evidence, gained from group discussions at UK-wide Medical Research Council (MRC) quality of life training days, suggests there are inconsistent standards of HRQL data collection in trials and appropriate training and education is often lacking. Our objective was to investigate these reports, to determine if they represented isolated experiences, or were indicative of a potentially wider problem. Methods And Findings We undertook a qualitative study, conducting 26 semi-structured interviews with research nurses, data managers, trial coordinators and research facilitators involved in the collection and entry of HRQL data in clinical trials, across one primary care NHS trust, two secondary care NHS trusts and two clinical trials units in the UK. We used conventional content analysis to analyze and interpret our data. Our study participants reported (1) inconsistent standards in HRQL measurement, both between, and within, trials, which appeared to risk the introduction of bias; (2), difficulties in dealing with HRQL data that raised concern for the well-being of the trial participant, which in some instances led to the delivery of non-protocol driven co-interventions, (3), a frequent lack of HRQL protocol content and appropriate training and education of trial staff, and (4) that HRQL data collection could be associated with emotional and/or ethical burden. Conclusions Our findings suggest there are inconsistencies in the standards of HRQL data collection in some trials resulting from a general lack of HRQL-specific protocol content, training and education. These inconsistencies could lead to biased HRQL trial results. Future research should aim to develop HRQL guidelines and training programmes aimed at supporting researchers to carry out high quality data collection. PMID:24124580

A Method of Managing Severe Traumatic Brain Injury in the Absence of Intracranial Pressure Monitoring: The Imaging and Clinical Examination Protocol.

PubMed

Chesnut, Randall M; Temkin, Nancy; Dikmen, Sureyya; Rondina, Carlos; Videtta, Walter; Petroni, Gustavo; Lujan, Silvia; Alanis, Victor; Falcao, Antonio; de la Fuenta, Gustavo; Gonzalez, Luis; Jibaja, Manuel; Lavarden, Arturo; Sandi, Freddy; Mérida, Roberto; Romero, Ricardo; Pridgeon, Jim; Barber, Jason; Machamer, Joan; Chaddock, Kelley

2018-01-01

The imaging and clinical examination (ICE) algorithm used in the Benchmark Evidence from South American Trials: Treatment of Intracranial Pressure (BEST TRIP) randomized controlled trial is the only prospectively investigated clinical protocol for traumatic brain injury management without intracranial pressure (ICP) monitoring. As the default literature standard, it warrants careful evaluation. We present the ICE protocol in detail and analyze the demographics, outcome, treatment intensity, frequency of intervention usage, and related adverse events in the ICE-protocol cohort. The 167 ICE protocol patients were young (median 29 years) with a median Glasgow Coma Scale motor score of 4 but with anisocoria or abnormal pupillary reactivity in 40%. This protocol produced outcomes not significantly different from those randomized to the monitor-based protocol (favorable 6-month extended Glasgow Outcome Score in 39%; 41% mortality rate). Agents commonly employed to treat suspected intracranial hypertension included low-/moderate-dose hypertonic saline (72%) and mannitol (57%), mild hyperventilation (adjusted partial pressure of carbon dioxide 30-35 mm Hg in 73%), and pressors to maintain cerebral perfusion (62%). High-dose hyperosmotics or barbiturates were uncommonly used. Adverse event incidence was low and comparable to the BEST TRIP monitored group. Although this protocol should produce similar/acceptable results under circumstances comparable to those in the trial, influences such as longer pre-hospital times and non-specialist transport personnel, plus an intensive care unit model of aggressive physician-intensive care by small groups of neurotrauma-focused intensivists, which differs from most high-resource models, support caution in expecting the same results in dissimilar settings. Finally, this protocol's ICP-titration approach to suspected intracranial hypertension (vs. crisis management for monitored ICP) warrants further study.

Evidence-based protocol for structural rehabilitation of the spine and posture: review of clinical biomechanics of posture (CBP®) publications

PubMed Central

Oakley, Paul A.; Harrison, Donald D.; Harrison, Deed E.; Haas, Jason W.

2005-01-01

BACKGROUND Although practice protocols exist for SMT and functional rehabilitation, no practice protocols exist for structural rehabilitation. Traditional chiropractic practice guidelines have been limited to acute and chronic pain treatment, with limited inclusion of functional and exclusion of structural rehabilitation procedures. OBJECTIVE (1) To derive an evidence-based practice protocol for structural rehabilitation from publications on Clinical Biomechanics of Posture (CBP®) methods, and (2) to compare the evidence for Diversified, SMT, and CBP®. METHODS Clinical control trials utilizing CBP® methods and spinal manipulative therapy (SMT) were obtained from searches in Mantis, CINAHL, and Index Medicus. Using data from SMT review articles, evidence for Diversified Technique (as taught in chiropractic colleges), SMT, and CBP® were rated and compared. RESULTS From the evidence from Clinical Control Trials on SMT and CBP®, there is very little evidence support for Diversified (our rating = 18), as taught in chiropractic colleges, for the treatment of pain subjects, while CBP® (our rating = 46) and SMT for neck pain (rating = 58) and low back pain (our rating = 202) have evidence-based support. CONCLUSIONS While CBP® Technique has approximately as much evidence-based support as SMT for neck pain, CBP® has more evidence to support its methods than the Diversified technique taught in chiropractic colleges, but not as much as SMT for low back pain. The evolution of chiropractic specialization has occurred, and doctors providing structural-based chiropractic care require protocol guidelines for patient quality assurance and standardization. A structural rehabilitation protocol was developed based on evidence from CBP® publications. PMID:17549209

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom.

PubMed

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

To develop a study aiming at optimizing myocardial perfusion imaging. Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The (99m)Tc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol.

Optimization of a protocol for myocardial perfusion scintigraphy by using an anthropomorphic phantom*

PubMed Central

Ramos, Susie Medeiros Oliveira; Glavam, Adriana Pereira; Kubo, Tadeu Takao Almodovar; de Sá, Lidia Vasconcellos

2014-01-01

Objective To develop a study aiming at optimizing myocardial perfusion imaging. Materials and Methods Imaging of an anthropomorphic thorax phantom with a GE SPECT Ventri gamma camera, with varied activities and acquisition times, in order to evaluate the influence of these parameters on the quality of the reconstructed medical images. The 99mTc-sestamibi radiotracer was utilized, and then the images were clinically evaluated on the basis of data such as summed stress score, and on the technical image quality and perfusion. The software ImageJ was utilized in the data quantification. Results The results demonstrated that for the standard acquisition time utilized in the procedure (15 seconds per angle), the injected activity could be reduced by 33.34%. Additionally, even if the standard scan time is reduced by 53.34% (7 seconds per angle), the standard injected activity could still be reduced by 16.67%, without impairing the image quality and the diagnostic reliability. Conclusion The described method and respective results provide a basis for the development of a clinical trial of patients in an optimized protocol. PMID:25741088

Action Observation Plus Sonification. A Novel Therapeutic Protocol for Parkinson’s Patient with Freezing of Gait

PubMed Central

Mezzarobba, Susanna; Grassi, Michele; Pellegrini, Lorella; Catalan, Mauro; Kruger, Bjorn; Furlanis, Giovanni; Manganotti, Paolo; Bernardis, Paolo

2018-01-01

Freezing of gait (FoG) is a disabling symptom associated with falls, with little or no responsiveness to pharmacological treatment. Current protocols used for rehabilitation are based on the use of external sensory cues. However, cued strategies might generate an important dependence on the environment. Teaching motor strategies without cues [i.e., action observation (AO) plus Sonification] could represent an alternative/innovative approach to rehabilitation that matters most on appropriate allocation of attention and lightening cognitive load. We aimed to test the effects of a novel experimental protocol to treat patients with Parkinson’s disease (PD) and FoG, using functional, and clinical scales. The experimental protocol was based on AO plus Sonification. 12 patients were treated with 8 motor gestures. They watched eight videos showing an actor performing the same eight gestures, and then tried to repeat each gesture. Each video was composed by images and sounds of the gestures. By means of the Sonification technique, the sounds of gestures were obtained by transforming kinematic data (velocity) recorded during gesture execution, into pitch variations. The same 8 motor gestures were also used in a second group of 10 patients; which were treated with a standard protocol based on a common sensory stimulation method. All patients were tested with functional and clinical scales before, after, at 1 month, and 3 months after the treatment. Data showed that the experimental protocol have positive effects on functional and clinical tests. In comparison with the baseline evaluations, significant performance improvements were seen in the NFOG questionnaire, and the UPDRS (parts II and III). Importantly, all these improvements were consistently observed at the end, 1 month, and 3 months after treatment. No improvement effects were found in the group of patients treated with the standard protocol. These data suggest that a multisensory approach based on AO plus Sonification, with the two stimuli semantically related, could help PD patients with FoG to relearn gait movements, to reduce freezing episodes, and that these effects could be prolonged over time. PMID:29354092

Team Training and Institutional Protocols to Prevent Shoulder Dystocia Complications.

PubMed

Smith, Samuel

2016-12-01

Shoulder dystocia is an obstetrical emergency that may result in significant neonatal complications. It requires rapid recognition and a coordinated response. Standardization of care, teamwork and communication, and clinical simulation are the key components of patient safety programs in obstetrics. Simulation-based team training and institutional protocols for the management of shoulder dystocia are emerging as integral components of many labor and delivery safety initiatives because of their impact on technical skills and team performance.

[Importance of clinical trial design and standardized implementation in ophthalmology].

PubMed

Xu, Xun

2013-06-01

Clinical trial is an important medical research method, as well as the bridge of translational medicine. The results of scientific evidences are useful to make clinical practice guidelines. At present,much experience of carrying out ophthalmology clinical trials has been obtained and achieved, but there are still some scientific, practical and ethical problems to be solved,because of their impact on the authenticity and reliability of the results. Therefore, attaching great importance to design of the clinical research and implement of the standardization would be the goal and the development direction. Clinical trial design rely on objective, follow international design principles on the ethics,randomization, blinding and placebo setting. During the trial implementation, personnel training,project management and monitoring would help to reduce protocol deviation and ensure data authenticity.

Modified Test Protocol Improves Sensitivity of the Stereo Fly Test.

PubMed

De La Cruz, Angie; Morale, Sarah E; Jost, Reed M; Kelly, Krista R; Birch, Eileen E

2016-01-01

Stereoacuity measurement is a common element of pediatric ophthalmic examinations. Although the Stereo Fly Test is routinely used to establish the presence of coarse stereopsis (3000 arcsecs), it often yields a false negative "pass" due to learned responses and non-stereoscopic cues. We developed and evaluated a modified Stereo Fly Test protocol aimed at increasing sensitivity, thus reducing false negatives. The Stereo Fly Test was administered according to manufacturer instructions to 321 children aged 3-12 years. Children with a "pass" outcome (n = 147) were re-tested wearing glasses fitted with polarizers of matching orientation for both eyes to verify that they were responding to stereoscopic cues (modified protocol). The response to the standard Stereo Fly Test was considered a false negative (pass) if the child still pinched above the plate after disparity cues were eliminated. Randot ® Preschool Stereoacuity and Butterfly Tests were used as gold standards. Sensitivity was 81% (95% CI: 0.75 - 0.86) for standard administration of the Stereo Fly Test (19% false negative "pass"). The modified protocol increased sensitivity to 90% (95% CI: 0.85 - 0.94). The modified two-step protocol is a simple and convenient way to administer the Stereo Fly Test with increased sensitivity in a clinical setting. © 2016 Board of regents of the University of Wisconsin System, American Orthoptic Journal, Volume 66, 2016, ISSN 0065-955X, E-ISSN 1553-4448.

Phase II clinical trial of combination chemotherapy with dexamethasone for lymphoma in dogs.

PubMed

Greenberg, Chelsea B; Boria, Pedro A; Borgatti-Jeffreys, Antonella; Raskin, Rose E; Lucroy, Michael D

2007-01-01

Dogs with histologically confirmed lymphoma were treated with a 14-week induction chemotherapy protocol that included dexamethasone. A phase II clinical trial was done using a standard two-stage design. Complete remission occurred in 21 (88%) dogs, with a median initial progression-free interval of 186 days. Toxicity was mild and self-limiting in the majority of dogs.

Microfluidic Transduction Harnesses Mass Transport Principles to Enhance Gene Transfer Efficiency.

PubMed

Tran, Reginald; Myers, David R; Denning, Gabriela; Shields, Jordan E; Lytle, Allison M; Alrowais, Hommood; Qiu, Yongzhi; Sakurai, Yumiko; Li, William C; Brand, Oliver; Le Doux, Joseph M; Spencer, H Trent; Doering, Christopher B; Lam, Wilbur A

2017-10-04

Ex vivo gene therapy using lentiviral vectors (LVs) is a proven approach to treat and potentially cure many hematologic disorders and malignancies but remains stymied by cumbersome, cost-prohibitive, and scale-limited production processes that cannot meet the demands of current clinical protocols for widespread clinical utilization. However, limitations in LV manufacture coupled with inefficient transduction protocols requiring significant excess amounts of vector currently limit widespread implementation. Herein, we describe a microfluidic, mass transport-based approach that overcomes the diffusion limitations of current transduction platforms to enhance LV gene transfer kinetics and efficiency. This novel ex vivo LV transduction platform is flexible in design, easy to use, scalable, and compatible with standard cell transduction reagents and LV preparations. Using hematopoietic cell lines, primary human T cells, primary hematopoietic stem and progenitor cells (HSPCs) of both murine (Sca-1 + ) and human (CD34 + ) origin, microfluidic transduction using clinically processed LVs occurs up to 5-fold faster and requires as little as one-twentieth of LV. As an in vivo validation of the microfluidic-based transduction technology, HSPC gene therapy was performed in hemophilia A mice using limiting amounts of LV. Compared to the standard static well-based transduction protocols, only animals transplanted with microfluidic-transduced cells displayed clotting levels restored to normal. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

Metabolomic changes in serum of children with different clinical diagnoses of malnutrition

USDA-ARS?s Scientific Manuscript database

Mortality in children with severe acute malnutrition (SAM) remains high despite standardized rehabilitation protocols. Two forms of SAM are classically distinguished: kwashiorkor and marasmus. Children with kwashiorkor have nutritional edema and metabolic disturbances, including hypoalbuminemia and ...

Clinical epidemiology survey of the traditional Chinese medicine etiology and syndrome differentiation of coronary artery disease: study protocol of a multicenter trial.

PubMed

Bi, Ying-fei; Mao, Jing-yuan; Wang, Xian-liang; Hou, Ya-zhu; Lu, Yi-zhu; Soh, Shan Bin; Zhang, Bo-li

2012-06-01

Coronary artery disease (CAD), a common disease with high incidence and mortality rate, has seriously threatened the health and life of the public. Traditional Chinese medicine (TCM) has an important role in the prevention and treatment of this disease. Through clinical epidemiological survey, a deeper understanding of TCM etiology and syndrome characteristics in CAD would further improve clinical efficacy in the treatment of this disease. The preliminary clinical questionnaire for TCM etiology and syndrome differentiation in CAD was designed after literature reviews and analysis. Through a series of clinical pre-surveys, expert consultation and demonstration, the formal TCM clinical epidemiology questionnaire on the etiology and syndrome differentiation in CAD was finalized, after which, the study protocol, inclusive and exclusive criteria and related quality control measures were prepared. The multiregional clinical epidemiological survey with more than 5000 participants with CAD will be carried out in 41 TCM hospitals of China for investigating the TCM etiology and syndrome differentiation of CAD. Multiregion large sample size clinical epidemiology survey on TCM etiology and syndrome differentiation in CAD will provide further evidence in preventing CAD and improving the standardization process of syndrome research. This study protocol was registered at the Chinese Clinical Trial Registry on November 27, 2011 in both Chinese and English editions and the registration number is ChiCTR-ECS-11001728.

Pressure ulcer risk assessment and prevention: a systematic comparative effectiveness review.

PubMed

Chou, Roger; Dana, Tracy; Bougatsos, Christina; Blazina, Ian; Starmer, Amy J; Reitel, Katie; Buckley, David I

2013-07-02

Pressure ulcers are associated with substantial health burdens but may be preventable. To review the clinical utility of pressure ulcer risk assessment instruments and the comparative effectiveness of preventive interventions in persons at higher risk. MEDLINE (1946 through November 2012), CINAHL, the Cochrane Library, grant databases, clinical trial registries, and reference lists. Randomized trials and observational studies on effects of using risk assessment on clinical outcomes and randomized trials of preventive interventions on clinical outcomes. Multiple investigators abstracted and checked study details and quality using predefined criteria. One good-quality trial found no evidence that use of a pressure ulcer risk assessment instrument, with or without a protocolized intervention strategy based on assessed risk, reduces risk for incident pressure ulcers compared with less standardized risk assessment based on nurses' clinical judgment. In higher-risk populations, 1 good-quality and 4 fair-quality randomized trials found that more advanced static support surfaces were associated with lower risk for pressure ulcers compared with standard mattresses (relative risk range, 0.20 to 0.60). Evidence on the effectiveness of low-air-loss and alternating-air mattresses was limited, with some trials showing no clear differences from advanced static support surfaces. Evidence on the effectiveness of nutritional supplementation, repositioning, and skin care interventions versus usual care was limited and had methodological shortcomings, precluding strong conclusions. Only English-language articles were included, publication bias could not be formally assessed, and most studies had methodological shortcomings. More advanced static support surfaces are more effective than standard mattresses for preventing ulcers in higher-risk populations. The effectiveness of formal risk assessment instruments and associated intervention protocols compared with less standardized assessment methods and the effectiveness of other preventive interventions compared with usual care have not been clearly established.

Standardized Reporting of the Eczema Area and Severity Index (EASI) and the Patient-Oriented Eczema Measure (POEM): A Recommendation by the Harmonising Outcome Measures for Eczema (HOME) Initiative.

PubMed

Grinich, E; Schmitt, J; Küster, D; Spuls, P I; Williams, H C; Chalmers, J R; Thomas, K S; Apfelbacher, C; Prinsen, C A C; Furue, M; Stuart, B; Carter, B; Simpson, E

2018-05-10

Several organizations from multiple fields of medicine are setting standards for clinical research including protocol development, 1 harmonization of outcome reporting, 2 statistical analysis, 3 quality assessment 4 and reporting of findings. 1 Clinical research standardization facilitates the interpretation and synthesis of data, increases the usability of trial results for guideline groups and shared decision-making, and reduces selective outcome reporting bias. The mission of the Harmonising Outcome Measures for Eczema (HOME) initiative is to establish an agreed-upon core set of outcomes to be measured and reported in all clinical trials of atopic dermatitis (AD). This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

In-Office Endoscopic Laryngeal Laser Procedures: A Patient Safety Initiative.

PubMed

Anderson, Jennifer; Bensoussan, Yael; Townsley, Richard; Kell, Erika

2018-05-01

Objective To review complications of in-office endoscopic laryngeal laser procedures after implementation of standardized safety protocol. Methods A retrospective review was conducted of the first 2 years of in-office laser procedures at St Michaels Hospital after the introduction of a standardized safety protocol. The protocol included patient screening, procedure checklist with standardized reporting of processes, medications, and complications. Primary outcomes measured were complication rates of in-office laryngeal laser procedures. Secondary outcomes included hemodynamic changes, local anesthetic dose, laser settings, total laser/procedure time, and incidence of sedation. Results A total of 145 in-office KTP procedures performed on 65 patients were reviewed. In 98% of cases, the safety protocol was fully implemented. The overall complication rate was 4.8%. No major complications were encountered. Minor complications included vasovagal episodes and patient intolerance. The rate of patient intolerance resulting early termination of anticipated procedure was 13.1%. Total local anesthetic dose averaged 172.9 mg lidocaine per procedure. The mean amount of laser energy dispersed was 261.2 J, with mean total procedure time of 48.3 minutes. Sixteen percent of patients had preprocedure sedation. Vital signs were found to vary modestly. Systolic blood pressure was lower postprocedure in 13.8% and symptomatic in 4.1%. Discussion The review of our standardized safety protocol has revealed that in-office laser treatment for laryngeal pathology has extremely low complication rates with safe patient outcomes. Implications for Practice The trend of shifting procedures out of the operating room into the office/clinic setting requires new processes designed to promote patient safety.

Production, concentration and titration of pseudotyped HIV-1-based lentiviral vectors.

PubMed

Kutner, Robert H; Zhang, Xian-Yang; Reiser, Jakob

2009-01-01

Over the past decade, lentiviral vectors have emerged as powerful tools for transgene delivery. The use of lentiviral vectors has become commonplace and applications in the fields of neuroscience, hematology, developmental biology, stem cell biology and transgenesis are rapidly emerging. Also, lentiviral vectors are at present being explored in the context of human clinical trials. Here we describe improved protocols to generate highly concentrated lentiviral vector pseudotypes involving different envelope glycoproteins. In this protocol, vector stocks are prepared by transient transfection using standard cell culture media or serum-free media. Such stocks are then concentrated by ultracentrifugation and/or ion exchange chromatography, or by precipitation using polyethylene glycol 6000, resulting in vector titers of up to 10(10) transducing units per milliliter and above. We also provide reliable real-time PCR protocols to titrate lentiviral vectors based on proviral DNA copies present in genomic DNA extracted from transduced cells or on vector RNA. These production/concentration methods result in high-titer vector preparations that show reduced toxicity compared with lentiviral vectors produced using standard protocols involving ultracentrifugation-based methods. The vector production and titration protocol described here can be completed within 8 d.

Early weight-bearing after periacetabular osteotomy leads to a high incidence of postoperative pelvic fractures.

PubMed

Ito, Hiroshi; Tanino, Hiromasa; Sato, Tatsuya; Nishida, Yasuhiro; Matsuno, Takeo

2014-07-11

It has not been shown whether accelerated rehabilitation following periacetabular osteotomy (PAO) is effective for early recovery. The purpose of this retrospective study was to compare complication rates in patients with standard and accelerated rehabilitation protocols who underwent PAO. Between January 2002 and August 2011, patients with a lateral center-edge (CE) angle of < 20°, showing good joint congruency with the hip in abduction, pre- or early stage of osteoarthritis, and age younger than 60 years were included in this study. We evaluated 156 hips in 138 patients, with a mean age at the time of surgery of 30 years. Full weight-bearing with two crutches started 2 months postoperatively in 73 patients (80 hips) with the standard rehabilitation protocol. In 65 patients (76 hips) with the accelerated rehabilitation protocol, postoperative strengthening of the hip, thigh and core musculature was begun on the day of surgery as tolerated. The exercise program included active hip range of motion, and gentle isometric hamstring and quadriceps muscle sets; these exercises were performed for 30 minutes in the morning and 30 minutes in the afternoon with a physical therapist every weekday for 6 weeks. Full weight-bearing with two axillary crutches started on the day of surgery as tolerated. Complications were evaluated for 2 years. The clinical results at the time of follow-up were similar in the two groups. The average periods between the osteotomy and full-weight-bearing walking without support were 4.2 months and 6.9 months in patients with the accelerated and standard rehabilitation protocols (P < 0.001), indicating that the accelerated rehabilitation protocol could achieve earlier recovery of patients. However, postoperative fractures of the ischial ramus and posterior column of the pelvis were more frequently found in patients with the accelerated rehabilitation protocol (8/76) than in those with the standard rehabilitation protocol (1/80) (P = 0.013). The accelerated rehabilitation protocol seems to have advantages for early muscle recovery in patients undergoing PAO; however, postoperative pelvic fracture rates were unacceptably high in patients with this protocol.

Early weight-bearing after periacetabular osteotomy leads to a high incidence of postoperative pelvic fractures

PubMed Central

2014-01-01

Background It has not been shown whether accelerated rehabilitation following periacetabular osteotomy (PAO) is effective for early recovery. The purpose of this retrospective study was to compare complication rates in patients with standard and accelerated rehabilitation protocols who underwent PAO. Methods Between January 2002 and August 2011, patients with a lateral center-edge (CE) angle of < 20°, showing good joint congruency with the hip in abduction, pre- or early stage of osteoarthritis, and age younger than 60 years were included in this study. We evaluated 156 hips in 138 patients, with a mean age at the time of surgery of 30 years. Full weight-bearing with two crutches started 2 months postoperatively in 73 patients (80 hips) with the standard rehabilitation protocol. In 65 patients (76 hips) with the accelerated rehabilitation protocol, postoperative strengthening of the hip, thigh and core musculature was begun on the day of surgery as tolerated. The exercise program included active hip range of motion, and gentle isometric hamstring and quadriceps muscle sets; these exercises were performed for 30 minutes in the morning and 30 minutes in the afternoon with a physical therapist every weekday for 6 weeks. Full weight-bearing with two axillary crutches started on the day of surgery as tolerated. Complications were evaluated for 2 years. Results The clinical results at the time of follow-up were similar in the two groups. The average periods between the osteotomy and full-weight-bearing walking without support were 4.2 months and 6.9 months in patients with the accelerated and standard rehabilitation protocols (P < 0.001), indicating that the accelerated rehabilitation protocol could achieve earlier recovery of patients. However, postoperative fractures of the ischial ramus and posterior column of the pelvis were more frequently found in patients with the accelerated rehabilitation protocol (8/76) than in those with the standard rehabilitation protocol (1/80) (P = 0.013). Conclusion The accelerated rehabilitation protocol seems to have advantages for early muscle recovery in patients undergoing PAO; however, postoperative pelvic fracture rates were unacceptably high in patients with this protocol. PMID:25015753

Gonadotrophin-releasing hormone antagonists for assisted conception.

PubMed

Al-Inany, H G; Abou-Setta, A M; Aboulghar, M

2006-07-19

Gonadotrophin-releasing hormone antagonists produce immediate suppression of gonadotrophin secretion, hence, they can be given after starting gonadotrophin administration. This has resulted in dramatic reduction in the duration of treatment cycle. Two different regimes have been described. The multiple-dose protocol involves the administration of 0.25 mg cetrorelix (or ganirelix) daily from day six to seven of stimulation, or when the leading follicle is 14 to15 mm, until human chorionic gonadotrophin (HCG) administration and the single-dose protocol involves the single administration of 3 mg cetrorelix on day seven to eight of stimulation. Assuming comparable clinical outcome, these benefits would justify a change from the standard long protocol of GnRH agonists to the new GnRH antagonist regimens. To evaluate the evidence regarding the efficacy of gonadotrophin-releasing hormone (GnRH) antagonists with the standard long protocol of GnRH agonists for controlled ovarian hyperstimulation in assisted conception. We searched Cochrane Menstrual Disorders and Subfertility Group's Specialised Register, MEDLINE and EMBASE databases from 1987 to February 2006, and handsearched bibliographies of relevant publications and reviews, and abstracts of scientific meetings. We also contacted manufacturers in the field. Randomized controlled studies comparing different protocols of GnRH antagonists with GnRH agonists in assisted conception cycles were included in this review. Two authors independently assessed trial quality and extracted data. If relevant data were missing or unclear, the authors have been consulted Twenty seven RCTs comparing the GnRH antagonist to the long protocol of GnRH agonist fulfilled the inclusion criteria. Clinical pregnancy rate was significantly lower in the antagonist group. (OR = 0.84, 95% CI = 0.72 - 0.97). The ongoing pregnancy/ live-birth rate showed the same significant lower pregnancy in the antagonist group (P = 0.03; OR 0.82, 95% CI 0.69 to 0.98).However, there was statistically significant reduction in incidence of severe OHSS with antagonist protocol. The relative risk ratio was (P = 0.01; RR 0.61, 95% CI 0.42 to 0.89). In addition, interventions to prevent OHSS (e.g. coasting, cycle cancellation) were administered more frequently in the agonist group (P = 0.03; OR 0.44, 95% CI 0.21 to 0.93). GnRH antagonist protocol is a short and simple protocol with good clinical outcome with significant reduction in incidence of severe ovarian hyperstimulation syndrome and amount of gonadotrophins but the lower pregnancy rate compared to the GnRH agonist long protocol necessitates counseling subfertile couples before recommending change from GnRH agonist to antagonist..

Knowledge translation interventions for critically ill patients: a systematic review*.

PubMed

Sinuff, Tasnim; Muscedere, John; Adhikari, Neill K J; Stelfox, Henry T; Dodek, Peter; Heyland, Daren K; Rubenfeld, Gordon D; Cook, Deborah J; Pinto, Ruxandra; Manoharan, Venika; Currie, Jan; Cahill, Naomi; Friedrich, Jan O; Amaral, Andre; Piquette, Dominique; Scales, Damon C; Dhanani, Sonny; Garland, Allan

2013-11-01

We systematically reviewed ICU-based knowledge translation studies to assess the impact of knowledge translation interventions on processes and outcomes of care. We searched electronic databases (to July, 2010) without language restrictions and hand-searched reference lists of relevant studies and reviews. Two reviewers independently identified randomized controlled trials and observational studies comparing any ICU-based knowledge translation intervention (e.g., protocols, guidelines, and audit and feedback) to management without a knowledge translation intervention. We focused on clinical topics that were addressed in greater than or equal to five studies. Pairs of reviewers abstracted data on the clinical topic, knowledge translation intervention(s), process of care measures, and patient outcomes. For each individual or combination of knowledge translation intervention(s) addressed in greater than or equal to three studies, we summarized each study using median risk ratio for dichotomous and standardized mean difference for continuous process measures. We used random-effects models. Anticipating a small number of randomized controlled trials, our primary meta-analyses included randomized controlled trials and observational studies. In separate sensitivity analyses, we excluded randomized controlled trials and collapsed protocols, guidelines, and bundles into one category of intervention. We conducted meta-analyses for clinical outcomes (ICU and hospital mortality, ventilator-associated pneumonia, duration of mechanical ventilation, and ICU length of stay) related to interventions that were associated with improvements in processes of care. From 11,742 publications, we included 119 investigations (seven randomized controlled trials, 112 observational studies) on nine clinical topics. Interventions that included protocols with or without education improved continuous process measures (seven observational studies and one randomized controlled trial; standardized mean difference [95% CI]: 0.26 [0.1, 0.42]; p = 0.001 and four observational studies and one randomized controlled trial; 0.83 [0.37, 1.29]; p = 0.0004, respectively). Heterogeneity among studies within topics ranged from low to extreme. The exclusion of randomized controlled trials did not change our results. Single-intervention and lower-quality studies had higher standardized mean differences compared to multiple-intervention and higher-quality studies (p = 0.013 and 0.016, respectively). There were no associated improvements in clinical outcomes. Knowledge translation interventions in the ICU that include protocols with or without education are associated with the greatest improvements in processes of critical care.

Graduate Periodontics Programs' Integration of Implant Provisionalization in Core Curricula: Implementation of CODA Standard 4-10.2.d.

PubMed

Barwacz, Christopher A; Pantzlaff, Ed; Allareddy, Veerasathpurush; Avila-Ortiz, Gustavo

2017-06-01

The aim of this descriptive study was to provide an overview of the status of implementation of Commission on Dental Accreditation (CODA) Standard 4-10.2.d (Provisionalization of Dental Implants) by U.S. graduate periodontics programs since its introduction in 2013. Surveys were sent in May 2015 to 56 accredited postdoctoral periodontics program directors to ascertain program director characteristics; status of planning, implementation, and curriculum resulting from adoption of Standard 4-10.2.d; preferred clinical protocols for implant provisionalization; interdisciplinary educational collaborators; and competency assessment mechanisms. The survey response rate was 52% (N=29); the majority were male, aged 55 or older, and had held their position for less than ten years. Among the responding programs, 93% had formal educational curricula established in implant provisionalization. Graduate periodontics (96%) and prosthodontics (63%) faculty members were predominantly involved with curriculum planning. Of these programs, 96% used immediate implant provisionalization, with direct (chairside) provisionalization protocols (86%) being preferred over indirect protocols (14%) and polyethylethylketone provisional abutments (75%) being preferred to titanium (25%) provisional abutments. Straight and concave transmucosal emergence profile designs (46% each) were preferred in teaching, with only 8% of programs favoring convex transmucosal profiles. A majority of responding programs (67%) lacked protocols for communicating to the restorative referral a mechanism to duplicate the mature peri-implant mucosal architecture. Regional location did not play a significant role in any educational component related to implant provisionalization for these graduate periodontal programs. Overall, this study found that a clear majority of graduate periodontics programs had established formal curricula related to implant provisionalization, with substantial clinical and philosophical consensus within the specialty.

Outpatient desensitization in selected patients with platinum hypersensitivity reactions.

PubMed

O'Malley, David M; Vetter, Monica Hagan; Cohn, David E; Khan, Ambar; Hays, John L

2017-06-01

Platinum-based chemotherapies are a standard treatment for both initial and recurrent gynecologic cancers. Given this widespread use, it is important to be aware of the features of platinum hypersensitivity reactions and the subsequent treatment of these reactions. There is also increasing interest in the development of desensitization protocols to allow patients with a history of platinum hypersensitivity to receive further platinum based therapy. In this review, we describe the management of platinum hypersensitivity reactions and the desensitization protocols utilized at our institution. We also describe the clinical categorizations utilized to triage patients to appropriate desensitization protocols. Copyright © 2017 Elsevier Inc. All rights reserved.

Protocol for Usability Testing and Validation of the ISO Draft International Standard 19223 for Lung Ventilators

PubMed Central

2017-01-01

Background Clinicians, such as respiratory therapists and physicians, are often required to set up pieces of medical equipment that use inconsistent terminology. Current lung ventilator terminology that is used by different manufacturers contributes to the risk of usage errors, and in turn the risk of ventilator-associated lung injuries and other conditions. Human factors and communication issues are often associated with ventilator-related sentinel events, and inconsistent ventilator terminology compounds these issues. This paper describes our proposed protocol, which will be implemented at the University of Waterloo, Canada when this project is externally funded. Objective We propose to determine whether a standardized vocabulary improves the ease of use, safety, and utility as it relates to the usability of medical devices, compared to legacy medical devices from multiple manufacturers, which use different terms. Methods We hypothesize that usage errors by clinicians will be lower when standardization is consistently applied by all manufacturers. The proposed study will experimentally examine the impact of standardized nomenclature on performance declines in the use of an unfamiliar ventilator product in clinically relevant scenarios. Participants will be respiratory therapy practitioners and trainees, and we propose studying approximately 60 participants. Results The work reported here is in the proposal phase. Once the protocol is implemented, we will report the results in a follow-up paper. Conclusions The proposed study will help us better understand the effects of standardization on medical device usability. The study will also help identify any terms in the International Organization for Standardization (ISO) Draft International Standard (DIS) 19223 that may be associated with recurrent errors. Amendments to the standard will be proposed if recurrent errors are identified. This report contributes a protocol that can be used to assess the effect of standardization in any given domain that involves equipment, multiple manufacturers, inconsistent vocabulary, symbology, audio tones, or patterns in interface navigation. Second, the protocol can be used to experimentally evaluate the ISO DIS 19223 for its effectiveness, as researchers around the world may wish to conduct such tests and compare results. PMID:28887292

Features Associated with Successful Recruitment of Diverse Patients onto Cancer Clinical Trials: Report from the American College of Surgeons Oncology Group

PubMed Central

Diehl, Kathleen M.; Green, Erin M.; Weinberg, Armin; Frederick, Wayne A.; Holmes, Dennis R.; Green, Bettye; Morris, Arden; Kuerer, Henry M.; Beltran, Robert A.; Mendez, Jane; Gines, Venus; Ota, David M.; Nelson, Heidi; Newman, Lisa A.

2018-01-01

Background The clinical trials mechanism of standardized treatment and follow-up for cancer patients with similar stages and patterns of disease is the most powerful approach available for evaluating the efficacy of novel therapies, and clinical trial participation should protect against delivery of care variations associated with racial/ethnic identity and/or socioeconomic status. Unfortunately, disparities in clinical trial accrual persist, with African Americans (AA) and Hispanic/Latino Americans (HA) underrepresented in most studies. Study Design We evaluated the accrual patterns for ten clinical trials conducted by the American College of Surgeons Oncology Group (ACOSOG) 1999–2009, and analyzed results by race/ethnicity as well as study design. Results Eight of ten protocols were successful in recruiting AA and/or HA participants; three of four randomized trials were successful. Features that were present among all of the successfully-recruiting protocols were: (i) studies designed to recruit patients with regional or advanced-stage disease (2/2 protocols); and (ii) studies that involved some investigational systemic therapy (3/3 protocols). Discussion AA and HA cancer patients can be successfully accrued onto randomized clinical trials, but study design affects recruitment patterns. Increased socioeconomic disadvantages observed within minority-ethnicity communities results in barriers to screening and more advanced cancer stage distribution. Improving cancer early detection is critical in the effort to eliminate outcome disparities but existing differences in disease burden results in diminished eligibility for early-stage cancer clinical trials among minority-ethnicity patients. PMID:21681382

Metabolic acidosis in neonatal calf diarrhea-clinical findings and theoretical assessment of a simple treatment protocol.

PubMed

Trefz, F M; Lorch, A; Feist, M; Sauter-Louis, C; Lorenz, I

2012-01-01

Clinical assessment of metabolic acidosis in calves with neonatal diarrhea can be difficult because increased blood concentrations of d-lactate and not acidemia per se are responsible for most of the clinical signs exhibited by these animals. To describe the correlation between clinical and laboratory findings and d-lactate concentrations. Furthermore, the theoretical outcome of a simplified treatment protocol based on posture/ability to stand and degree of dehydration was evaluated. A total of 121 calves with diagnosis of neonatal diarrhea admitted to a veterinary teaching hospital during an 8-month study period. Prospective blinded cohort study. Physical examinations were carried out following a standardized protocol. Theoretical outcome of treatment was calculated. Type and degree of metabolic acidosis were age dependent. The clinical parameters posture, behavior, and palpebral reflex were closely correlated to base excess (r = 0.74, 0.78, 0.68; P < .001) and d-lactate concentrations (r = 0.59, 0.59, 0.71; P < .001), respectively. Thus, determining the degree of loss of the palpebral reflex was identified as the best clinical tool for diagnosing increase in serum d-lactate concentrations. Theoretical outcome of treatment revealed that the tested dosages of sodium bicarbonate are more likely to overdose than to underdose calves with diarrhea and metabolic acidosis. The degree of metabolic acidosis in diarrheic calves can be predicted based on clinical findings. The assessed protocol provides a useful tool to determine bicarbonate requirements, but a revision is necessary for calves with ability to stand and marked metabolic acidosis. Copyright © 2011 by the American College of Veterinary Internal Medicine.

The Length of Child Anxiety Treatment in a Regional Health System.

PubMed

Whiteside, Stephen P H; Ale, Chelsea M; Young, Brennan; Olsen, Mark W; Biggs, Bridget K; Gregg, Melissa S; Geske, Jennifer R; Homan, Kendra

2016-12-01

Anxiety disorders are often undertreated due to unsuccessful dissemination of evidence-based treatments (EBTs). Lack of empirical data regarding the typical length of treatment in clinical settings may hamper the development of clinically relevant protocols. The current study examined billing records for 335 children ages 7-17 years to quantify the treatment received for newly diagnosed anxiety disorders within a regional health system. The vast majority of patients did not receive a sufficient number of appointments to complete the typical cognitive behavioral therapy protocol or reach the sessions introducing exposure. Although half of the sample received pharmacotherapy, the vast majority received fewer follow-up appointments than participants in pharmacotherapy research studies. Further, the type of treatment (i.e., number of sessions and medication) differed depending on utilization of specialty care. These results underscore the need to develop brief and flexible EBT protocols that can be standardized and implemented in community practice.

Digital pathology in nephrology clinical trials, research, and pathology practice.

PubMed

Barisoni, Laura; Hodgin, Jeffrey B

2017-11-01

In this review, we will discuss (i) how the recent advancements in digital technology and computational engineering are currently applied to nephropathology in the setting of clinical research, trials, and practice; (ii) the benefits of the new digital environment; (iii) how recognizing its challenges provides opportunities for transformation; and (iv) nephropathology in the upcoming era of kidney precision and predictive medicine. Recent studies highlighted how new standardized protocols facilitate the harmonization of digital pathology database infrastructure and morphologic, morphometric, and computer-aided quantitative analyses. Digital pathology enables robust protocols for clinical trials and research, with the potential to identify previously underused or unrecognized clinically useful parameters. The integration of digital pathology with molecular signatures is leading the way to establishing clinically relevant morpho-omic taxonomies of renal diseases. The introduction of digital pathology in clinical research and trials, and the progressive implementation of the modern software ecosystem, opens opportunities for the development of new predictive diagnostic paradigms and computer-aided algorithms, transforming the practice of renal disease into a modern computational science.

A system architecture for sharing de-identified, research-ready brain scans and health information across clinical imaging centers.

PubMed

Chervenak, Ann L; van Erp, Theo G M; Kesselman, Carl; D'Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G

2012-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment.

A System Architecture for Sharing De-Identified, Research-Ready Brain Scans and Health Information Across Clinical Imaging Centers

PubMed Central

Chervenak, Ann L.; van Erp, Theo G.M.; Kesselman, Carl; D’Arcy, Mike; Sobell, Janet; Keator, David; Dahm, Lisa; Murry, Jim; Law, Meng; Hasso, Anton; Ames, Joseph; Macciardi, Fabio; Potkin, Steven G.

2015-01-01

Progress in our understanding of brain disorders increasingly relies on the costly collection of large standardized brain magnetic resonance imaging (MRI) data sets. Moreover, the clinical interpretation of brain scans benefits from compare and contrast analyses of scans from patients with similar, and sometimes rare, demographic, diagnostic, and treatment status. A solution to both needs is to acquire standardized, research-ready clinical brain scans and to build the information technology infrastructure to share such scans, along with other pertinent information, across hospitals. This paper describes the design, deployment, and operation of a federated imaging system that captures and shares standardized, de-identified clinical brain images in a federation across multiple institutions. In addition to describing innovative aspects of the system architecture and our initial testing of the deployed infrastructure, we also describe the Standardized Imaging Protocol (SIP) developed for the project and our interactions with the Institutional Review Board (IRB) regarding handling patient data in the federated environment. PMID:22941984

Surfing the best practice guidelines: national clinical guideline clearinghouse in development.

PubMed

1997-08-01

The growth in development and usage of clinical guidelines during the last five years has been remarkable. Not only are health care practitioners reaching for what's deemed to be the best in protocols and practice, consumers, too, are looking toward standards and guidelines as they become more educated about the quality and quantity of health care services they should be receiving.

Informed Consent to Study Purpose in Randomized Clinical Trials of Antibiotics, 1991 Through 2011.

PubMed

Doshi, Peter; Hur, Peter; Jones, Mark; Albarmawi, Husam; Jefferson, Tom; Morgan, Daniel J; Spears, Patricia A; Powers, John H

2017-10-01

Potential research participants may assume that randomized trials comparing new interventions with older interventions always hypothesize greater efficacy for the new intervention, as in superiority trials. However, antibiotic trials frequently use "noninferiority" hypotheses allowing a degree of inferior efficacy deemed "clinically acceptable" compared with an older effective drug, in exchange for nonefficacy benefits (eg, decreased adverse effects). Considering these different benefit-harm trade-offs, proper informed consent necessitates supplying different information on the purposes of superiority and noninferiority trials. To determine the degree to which the study purpose is explained to potential participants in randomized clinical trials of antibiotics and the degree to which study protocols justify their selection of noninferiority hypotheses and amount of "clinically acceptable" inferiority. Cross-sectional analysis of study protocols, statistical analysis plans (SAPs), and informed consent forms (ICFs) from clinical study reports submitted to the European Medicines Agency. The ICFs were read by both methodologists and patient investigators. Protocols and SAPs were used as the reference standard to determine prespecified primary hypothesis and record rationale for selection of noninferiority hypotheses and noninferiority margins. This information was cross-referenced against ICFs to determine whether ICFs explained the study purpose. We obtained trial documents from 78 randomized trials with prespecified efficacy hypotheses (6 superiority, 72 noninferiority) for 17 antibiotics conducted between 1991 and 2011 that enrolled 39 407 patients. Fifty were included in the ICF analysis. All ICFs contained sections describing study purpose; however, none consistently conveyed study hypothesis to both methodologists and patient investigators. Methodologists found that 1 of 50 conveyed a study purpose. Patient investigators found that 11 of 50 conveyed a study purpose, 7 accurately and 4 inaccurately compared with the reference standard. Seventy-one of 72 noninferiority trial protocols or SAPs provided no rationale for selection of noninferiority hypothesis. None provided a clinical rationale for the chosen amount of decreased efficacy. Patients were not accurately informed of study purpose, which raises questions regarding the ethics of informed consent in antibiotic trials. Noninferiority and superiority trials entail different benefit-harm trade-offs that must be conveyed for ethical informed consent.

Risk of bias and confounding of observational studies of Zika virus infection: A scoping review of research protocols

PubMed Central

Haby, Michelle M.; Martínez-Vega, Ruth; Pinzón-Flores, Carlos E.; Smith, Emma; Pinart, Mariona; Broutet, Nathalie; Becerra-Posada, Francisco; Aldighieri, Sylvain; Van Kerkhove, Maria D.

2017-01-01

Introduction Given the severity and impact of the current Zika virus (ZIKV) outbreak in the Americas, numerous countries have rushed to develop research studies to assess ZIKV and its potential health consequences. In an effort to ensure that studies are comprehensive, both internally and externally valid, and with reliable results, the World Health Organization, the Pan American Health Organization, Institut Pasteur, the networks of Fiocruz, the Consortia for the Standardization of Influenza Seroepidemiology (CONSISE) and the International Severe Acute Respiratory and Emerging Infection Consortium (ISARIC) have generated six standardized clinical and epidemiological research protocols and questionnaires to address key public health questions on ZIKV. Methods We conducted a systematic search of ongoing study protocols related to ZIKV research. We analyzed the content of protocols of 32 cohort studies and 13 case control studies for systematic bias that could produce erroneous results. Additionally we aimed to characterize the risks of bias and confounding in observational studies related to ZIKV and to propose ways to minimize them, including the use of six newly standardized research protocols. Results Observational studies of ZIKV face an array of challenges, including measurement of exposure and outcomes (microcephaly and Guillain-Barré Syndrome). Potential confounders need to be measured where known and controlled for in the analysis. Selection bias due to non-random selection is a significant issue, particularly in the case-control design, and losses to follow-up is equally important for the cohort design. Conclusion Observational research seeking to answer key questions on the ZIKV should consider these restrictions and take precautions to minimize bias in an effort to provide reliable and valid results. Utilization of the standardized research protocols developed by the WHO, PAHO, Institut Pasteur, and CONSISE will harmonize the key methodological aspects of each study design to minimize bias at different stages of the study. Biases need to be considered by researchers implementing the standardized protocols as well as by users of observational epidemiological studies of ZIKV. PMID:28686621

Protocol and pilot data for establishing the Australian Stroke Clinical Registry.

PubMed

Cadilhac, Dominique A; Lannin, Natasha A; Anderson, Craig S; Levi, Christopher R; Faux, Steven; Price, Chris; Middleton, Sandy; Lim, Joyce; Thrift, Amanda G; Donnan, Geoffrey A

2010-06-01

Disease registries assist with clinical practice improvement. The Australian Stroke Clinical Registry aims to provide national, prospective, systematic data on processes and outcomes for stroke. We describe the methods of establishment and initial experience of operation. Australian Stroke Clinical Registry conforms to new national operating principles and technical standards for clinical quality registers. Features include: online data capture from acute public and private hospital sites; opt-out consent; expert consensus agreed core minimum dataset with standard definitions; outcomes assessed at 3 months poststroke; formal governance oversight; and formative evaluations for improvements. Qualitative feedback from sites indicates that the web-tool is simple to use and the user manuals, data dictionary, and training are appropriate. However, sites desire automated data-entry methods for routine demography variables and the opt-out consent protocol has sometimes been problematic. Data from 204 patients (median age 71 years, 54% males, 60% Australian) were collected from four pilot hospitals from June to October 2009 (mean, 50 cases per month) including ischaemic stroke (in 72%), intracerebral haemorrhage (16%), transient ischaemic attack (9%), and undetermined (3%), with only one case opting out. Australian Stroke Clinical Registry has been well established, but further refinements and broad roll-out are required before realising its potential of improving patient care through clinician feedback and allowance of local, national, and international comparative data.

In Vivo MRI Quantification of Individual Muscle and Organ Volumes for Assessment of Anabolic Steroid Growth Effects

PubMed Central

Wu, Ed X.; Tang, Haiying; Tong, Christopher; Heymsfield, Steve B.; Vasselli, Joseph R.

2015-01-01

This study aimed to develop a quantitative and in vivo magnetic resonance imaging (MRI) approach to investigate the muscle growth effects of anabolic steroids. A protocol of MRI acquisition on a standard clinical 1.5 Tesla scanner and quantitative image analysis was established and employed to measure the individual muscle and organ volumes in the intact and castrated guinea pigs undergoing a 16-week treatment protocol by two well-documented anabolic steroids, testosterone and nandrolone, via implanted silastic capsules. High correlations between the in vivo MRI and postmortem dissection measurements were observed for shoulder muscle complex (R = 0.86), masseter (R=0.79), temporalis (R=0.95), neck muscle complex (R=0.58), prostate gland and seminal vesicles (R=0.98), and testis (R=0.96). Furthermore, the longitudinal MRI measurements yielded adequate sensitivity to detect the restoration of growth to or towards normal in castrated guinea pigs by replacing circulating steroid levels to physiological or slightly higher levels, as expected. These results demonstrated that quantitative MRI using a standard clinical scanner provides accurate and sensitive measurement of individual muscles and organs, and this in vivo MRI protocol in conjunction with the castrated guinea pig model constitutes an effective platform to investigate the longitudinal and cross-sectional growth effects of other potential anabolic steroids. The quantitative MRI protocol developed can also be readily adapted for human studies on most clinical MRI scanner to investigate the anabolic steroid growth effects, or monitor the changes in individual muscle and organ volume and geometry following injury, strength training, neuromuscular disorders, and pharmacological or surgical interventions. PMID:18241900

Musculoskeletal MRI at 3.0 T and 7.0 T: a comparison of relaxation times and image contrast.

PubMed

Jordan, Caroline D; Saranathan, Manojkumar; Bangerter, Neal K; Hargreaves, Brian A; Gold, Garry E

2013-05-01

The purpose of this study was to measure and compare the relaxation times of musculoskeletal tissues at 3.0 T and 7.0 T, and to use these measurements to select appropriate parameters for musculoskeletal protocols at 7.0 T. We measured the T₁ and T₂ relaxation times of cartilage, muscle, synovial fluid, bone marrow and subcutaneous fat at both 3.0 T and 7.0 T in the knees of five healthy volunteers. The T₁ relaxation times were measured using a spin-echo inversion recovery sequence with six inversion times. The T₂ relaxation times were measured using a spin-echo sequence with seven echo times. The accuracy of both the T₁ and T₂ measurement techniques was verified in phantoms at both magnetic field strengths. We used the measured relaxation times to help design 7.0 T musculoskeletal protocols that preserve the favorable contrast characteristics of our 3.0 T protocols, while achieving significantly higher resolution at higher SNR efficiency. The T₁ relaxation times in all tissues at 7.0 T were consistently higher than those measured at 3.0 T, while the T₂ relaxation times at 7.0 T were consistently lower than those measured at 3.0 T. The measured relaxation times were used to help develop high resolution 7.0 T protocols that had similar fluid-to-cartilage contrast to that of the standard clinical 3.0 T protocols for the following sequences: proton-density-weighted fast spin-echo (FSE), T₂-weighted FSE, and 3D-FSE-Cube. The T₁ and T₂ changes were within the expected ranges. Parameters for musculoskeletal protocols at 7.0 T can be optimized based on these values, yielding improved resolution in musculoskeletal imaging with similar contrast to that of standard 3.0 T clinical protocols. Copyright © 2011 Elsevier Ireland Ltd. All rights reserved.

Enhancing the Detection of Dysmorphic Red Blood Cells and Renal Tubular Epithelial Cells with a Modified Urinalysis Protocol.

PubMed

Chu-Su, Yu; Shukuya, Kenichi; Yokoyama, Takashi; Lin, Wei-Chou; Chiang, Chih-Kang; Lin, Chii-Wann

2017-01-11

Urinary sediment is used to evaluate patients with possible urinary tract diseases. Currently, numerous protocols are applied to detect dysmorphic red blood cells (RBCs) and renal tubular epithelial cells (RTECs) in urinary sediment. However, distinct protocols are used by nephrologists and medical technologists for specimen concentration and observation, which leads to major discrepancies in the differential counts of formed elements such as dysmorphic RBCs and RTECs and might interfere with an accurate clinical diagnosis. To resolve these problems, we first tested a modified urinalysis protocol with an increased relative centrifuge force and concentration factor in 20 biopsy-confirmed glomerulonephritis patients with haematuria. We successfully improved the recovery ratio of dysmorphic RBCs in clinical specimens from 34.7% to 42.0% (P < 0.001). Furthermore, we confirmed the correlation between counts by the modified urinary protocol and Sysmex UF-1000i urinary flow cytometer (r ≥ 0.898, P < 0.001). A total of 28 types of isomorphic and dysmorphic RBCs were detected using a bright field microscope, with results comparable to those using a standard phase contrast microscope. Finally, we applied Sternheimer stain to enhance the contrast of RTECs in the urinary sediments. We concluded that this modified urinalysis protocol significantly enhanced the quality of urinalysis.

Enhancing the Detection of Dysmorphic Red Blood Cells and Renal Tubular Epithelial Cells with a Modified Urinalysis Protocol

PubMed Central

Chu-Su, Yu; Shukuya, Kenichi; Yokoyama, Takashi; Lin, Wei-Chou; Chiang, Chih-Kang; Lin, Chii-Wann

2017-01-01

Urinary sediment is used to evaluate patients with possible urinary tract diseases. Currently, numerous protocols are applied to detect dysmorphic red blood cells (RBCs) and renal tubular epithelial cells (RTECs) in urinary sediment. However, distinct protocols are used by nephrologists and medical technologists for specimen concentration and observation, which leads to major discrepancies in the differential counts of formed elements such as dysmorphic RBCs and RTECs and might interfere with an accurate clinical diagnosis. To resolve these problems, we first tested a modified urinalysis protocol with an increased relative centrifuge force and concentration factor in 20 biopsy-confirmed glomerulonephritis patients with haematuria. We successfully improved the recovery ratio of dysmorphic RBCs in clinical specimens from 34.7% to 42.0% (P < 0.001). Furthermore, we confirmed the correlation between counts by the modified urinary protocol and Sysmex UF-1000i urinary flow cytometer (r ≥ 0.898, P < 0.001). A total of 28 types of isomorphic and dysmorphic RBCs were detected using a bright field microscope, with results comparable to those using a standard phase contrast microscope. Finally, we applied Sternheimer stain to enhance the contrast of RTECs in the urinary sediments. We concluded that this modified urinalysis protocol significantly enhanced the quality of urinalysis. PMID:28074941

Quality assurance of data collection in the multi-site community randomized trial and prevalence survey of the children's healthy living program.

PubMed

Yamanaka, Ashley; Fialkowski, Marie Kainoa; Wilkens, Lynne; Li, Fenfang; Ettienne, Reynolette; Fleming, Travis; Power, Julianne; Deenik, Jonathan; Coleman, Patricia; Leon Guerrero, Rachael; Novotny, Rachel

2016-09-02

Quality assurance plays an important role in research by assuring data integrity, and thus, valid study results. We aim to describe and share the results of the quality assurance process used to guide the data collection process in a multi-site childhood obesity prevalence study and intervention trial across the US Affiliated Pacific Region. Quality assurance assessments following a standardized protocol were conducted by one assessor in every participating site. Results were summarized to examine and align the implementation of protocol procedures across diverse settings. Data collection protocols focused on food and physical activity were adhered to closely; however, protocols for handling completed forms and ensuring data security showed more variability. Quality assurance protocols are common in the clinical literature but are limited in multi-site community-based studies, especially in underserved populations. The reduction in the number of QA problems found in the second as compared to the first data collection periods for the intervention study attest to the value of this assessment. This paper can serve as a reference for similar studies wishing to implement quality assurance protocols of the data collection process to preserve data integrity and enhance the validity of study findings. NIH clinical trial #NCT01881373.

Validation of the A&D BP UA-651 device for home blood pressure measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Benetti, Elisabetta; Fania, Claudio; Palatini, Paolo

2014-02-01

The objective of this study was to determine the accuracy of the A&D BP UA-651 device for home blood pressure (BP) measurement according to the International Protocol of the European Society of Hypertension. Device evaluation was carried out in 33 patients. The mean age of the patients was 48.3±15.5 years, the mean systolic BP was 138.3±24.9 mmHg (range 90-180), the mean diastolic BP was 88.3±13.8 mmHg (range 60-108), and the mean arm circumference was 28.6±3.4 cm (range 23-36). The protocol requirements were followed precisely. The device passed all requirements, fulfilling the standards of the protocol. On average, the device underestimated the systolic BP by 0.4±4.4 mmHg and diastolic BP by 1.3±3.5 mmHg. The device-observer discrepancies were unrelated to patients' clinical characteristics. These data show that the A&D BP UA-651 device fulfilled the requirements for validation by the International Protocol and can be recommended for clinical use in the adult population.

The "ComPAS Trial" combined treatment model for acute malnutrition: study protocol for the economic evaluation.

PubMed

Lelijveld, Natasha; Bailey, Jeanette; Mayberry, Amy; Trenouth, Lani; N'Diaye, Dieynaba S; Haghparast-Bidgoli, Hassan; Puett, Chloe

2018-04-24

Acute malnutrition is currently divided into severe (SAM) and moderate (MAM) based on level of wasting. SAM and MAM currently have separate treatment protocols and products, managed by separate international agencies. For SAM, the dose of treatment is allocated by the child's weight. A combined and simplified protocol for SAM and MAM, with a standardised dose of ready-to-use therapeutic food (RUTF), is being trialled for non-inferior recovery rates and may be more cost-effective than the current standard protocols for treating SAM and MAM. This is the protocol for the economic evaluation of the ComPAS trial, a cluster-randomised controlled, non-inferiority trial that compares a novel combined protocol for treating uncomplicated acute malnutrition compared to the current standard protocol in South Sudan and Kenya. We will calculate the total economic costs of both protocols from a societal perspective, using accounting data, interviews and survey questionnaires. The incremental cost of implementing the combined protocol will be estimated, and all costs and outcomes will be presented as a cost-consequence analysis. Incremental cost-effectiveness ratio will be calculated for primary and secondary outcome, if statistically significant. We hypothesise that implementing the combined protocol will be cost-effective due to streamlined logistics at clinic level, reduced length of treatment, especially for MAM, and reduced dosages of RUTF. The findings of this economic evaluation will be important for policymakers, especially given the hypothesised non-inferiority of the main health outcomes. The publication of this protocol aims to improve rigour of conduct and transparency of data collection and analysis. It is also intended to promote inclusion of economic evaluation in other nutrition intervention studies, especially for MAM, and improve comparability with other studies. ISRCTN 30393230 , date: 16/03/2017.

Mobile phone-based clinical guidance for rural health providers in India.

PubMed

Gautham, Meenakshi; Iyengar, M Sriram; Johnson, Craig W

2015-12-01

There are few tried and tested mobile technology applications to enhance and standardize the quality of health care by frontline rural health providers in low-resource settings. We developed a media-rich, mobile phone-based clinical guidance system for management of fevers, diarrhoeas and respiratory problems by rural health providers. Using a randomized control design, we field tested this application with 16 rural health providers and 128 patients at two rural/tribal sites in Tamil Nadu, Southern India. Protocol compliance for both groups, phone usability, acceptability and patient feedback for the experimental group were evaluated. Linear mixed-model analyses showed statistically significant improvements in protocol compliance in the experimental group. Usability and acceptability among patients and rural health providers were very high. Our results indicate that mobile phone-based, media-rich procedural guidance applications have significant potential for achieving consistently standardized quality of care by diverse frontline rural health providers, with patient acceptance. © The Author(s) 2014.

Validation of the Tensoval Duo Control II blood pressure monitor for clinic use and self-measurement according to the British Hypertension Society protocol and the European Society of Hypertension International Protocol Revision 2010.

PubMed

de Greeff, Annemarie; Shennan, Andrew H

2013-06-01

The Tensoval Duo Control II is an automated upper arm device that uses a combination of oscillometric and auscultatory technology to determine blood pressure noninvasively. The accuracy of this device was assessed according to the British Hypertension Society (BHS) protocol and the European Society of Hypertension International Protocol revision 2010 (ESH-IP2) in an adult population. Ethical approval was obtained. Eighty-five and 33 adult individuals, respectively, were recruited to fulfil the requirements of each protocol. Trained observers took nine sequential same-arm measurements alternating between a mercury sphygmomanometer and the device. The device had to achieve at least a B grade for both systolic and diastolic pressures to pass the BHS protocol and had to fulfil the criteria of all three phases of the ESH-IP2 protocol to receive recommendation. The device achieved an A/A grading for the BHS protocol and passed all three phases of the ESH-IP2 protocol. The mean difference±SD for the BHS/ESH protocols, respectively, was -1.8±6.5/-0.7±5.7 mmHg for systolic pressure and 1.9±5.1/2.4±4.5 mmHg for diastolic pressure. The device maintained its A/A grading throughout the low-pressure, medium-pressure and high-pressure ranges. The Tensoval Duo Control II device is recommended for clinical and home use according to both the BHS and the ESH-IP2 standard.

Effects of Diet High in Palmitoleic Acid on Serum Lipid Levels and Metabolism.

DTIC Science & Technology

1998-04-01

be non-caloric decaffeinated . Up to five alcoholic drinks (wine, beer, or whiskey) were allowed per week. Consumption of all foods and beverages...standard sphygmoma- nometer by certified study personnel trained and standardized by protocols and methods. Phlebotomy and processing was also...hours, each subject had their blood drawn. Bloods were drawn and processed using trained phlebotomist and lab technicians in the portable clinic

Simulation improves procedural protocol adherence during central venous catheter placement: a randomized-controlled trial

PubMed Central

Peltan, Ithan D.; Shiga, Takashi; Gordon, James A.; Currier, Paul F.

2015-01-01

Background Simulation training may improve proficiency at and reduces complications from central venous catheter (CVC) placement, but the scope of simulation’s effect remains unclear. This randomized controlled trial evaluated the effects of a pragmatic CVC simulation program on procedural protocol adherence, technical skill, and patient outcomes. Methods Internal medicine interns were randomized to standard training for CVC insertion or standard training plus simulation-based mastery training. Standard training involved a lecture, a video-based online module, and instruction by the supervising physician during actual CVC insertions. Intervention-group subjects additionally underwent supervised training on a venous access simulator until they demonstrated procedural competence. Raters evaluated interns’ performance during internal jugular CVC placement on actual patients in the medical intensive care unit. Generalized estimating equations were used to account for outcome clustering within trainees. Results We observed 52 interns place 87 CVCs. Simulation-trained interns exhibited better adherence to prescribed procedural technique than interns who received only standard training (p=0.024). There were no significant differences detected in first-attempt or overall cannulation success rates, mean needle passes, global assessment scores or complication rates. Conclusions Simulation training added to standard training improved protocol adherence during CVC insertion by novice practitioners. This study may have been too small to detect meaningful differences in venous cannulation proficiency and other clinical outcomes, highlighting the difficulty of patient-centered simulation research in settings where poor outcomes are rare. For high-performing systems, where protocol deviations may provide an important proxy for rare procedural complications, simulation may improve CVC insertion quality and safety. PMID:26154250

Implant Mandibular Overdentures Retained by Immediately Loaded Implants: A 1-Year Randomized Trial Comparing the Clinical and Radiographic Outcomes Between Mini Dental Implants and Standard-Sized Implants.

PubMed

Zygogiannis, Kostas; Aartman, Irene Ha; Parsa, Azin; Tahmaseb, Ali; Wismeijer, Daniel

The aim of this 1-year randomized trial was to evaluate and compare the clinical and radiographic performance of four immediately loaded mini dental implants (MDIs) and two immediately loaded standard-sized tissue-level (STL) implants, placed in the interforaminal region of the mandible and used to retain mandibular overdentures (IODs) in completely edentulous patients. A total of 50 completely edentulous patients wearing conventional maxillary dentures and complaining about insufficient retention of their mandibular dentures were divided into two groups; 25 patients received four MDIs and 25 patients received two STL implants. The marginal bone loss (MBL) at the mesial and distal sides of each implant was assessed by means of standardized intraoral radiographs after a period of 1 year. Implant success and survival rates were also calculated. Immediate loading was possible for all patients in the first group. In the second group, an immediate loading protocol could not be applied for 10 patients. These patients were treated with a delayed loading protocol. A mean MBL of 0.42 ± 0.56 mm for the MDIs and 0.54 ± 0.49 mm for the immediately loaded STL implants was recorded at the end of the evaluation period. There was no statistically significant difference between the MDIs and the immediately loaded STL implants. Two MDIs failed, resulting in a survival rate of 98%. The success rate was 91%. For the immediately loaded conventional implants, the survival rate was 100% and the success rate 96.7% after 1 year of function. However, in 10 patients, the immediate loading protocol could not be followed. Considering the limitations of this short-term clinical study, immediate loading of four unsplinted MDIs or two splinted STL implants to retain mandibular overdentures seems to be a feasible treatment option. The marginal bone level changes around the MDIs were well within the clinically acceptable range.

Complete 3D kinematics of upper extremity functional tasks.

PubMed

van Andel, Carolien J; Wolterbeek, Nienke; Doorenbosch, Caroline A M; Veeger, DirkJan H E J; Harlaar, Jaap

2008-01-01

Upper extremity (UX) movement analysis by means of 3D kinematics has the potential to become an important clinical evaluation method. However, no standardized protocol for clinical application has yet been developed, that includes the whole upper limb. Standardization problems include the lack of a single representative function, the wide range of motion of joints and the complexity of the anatomical structures. A useful protocol would focus on the functional status of the arm and particularly the orientation of the hand. The aim of this work was to develop a standardized measurement method for unconstrained movement analysis of the UX that includes hand orientation, for a set of functional tasks for the UX and obtain normative values. Ten healthy subjects performed four representative activities of daily living (ADL). In addition, six standard active range of motion (ROM) tasks were executed. Joint angles of the wrist, elbow, shoulder and scapula were analyzed throughout each ADL task and minimum/maximum angles were determined from the ROM tasks. Characteristic trajectories were found for the ADL tasks, standard deviations were generally small and ROM results were consistent with the literature. The results of this study could form the normative basis for the development of a 'UX analysis report' equivalent to the 'gait analysis report' and would allow for future comparisons with pediatric and/or pathologic movement patterns.

Towards a five-minute comprehensive cardiac MR examination using highly accelerated parallel imaging with a 32-element coil array: feasibility and initial comparative evaluation.

PubMed

Xu, Jian; Kim, Daniel; Otazo, Ricardo; Srichai, Monvadi B; Lim, Ruth P; Axel, Leon; Mcgorty, Kelly Anne; Niendorf, Thoralf; Sodickson, Daniel K

2013-07-01

To evaluate the feasibility and perform initial comparative evaluations of a 5-minute comprehensive whole-heart magnetic resonance imaging (MRI) protocol with four image acquisition types: perfusion (PERF), function (CINE), coronary artery imaging (CAI), and late gadolinium enhancement (LGE). This study protocol was Health Insurance Portability and Accountability Act (HIPAA)-compliant and Institutional Review Board-approved. A 5-minute comprehensive whole-heart MRI examination protocol (Accelerated) using 6-8-fold-accelerated volumetric parallel imaging was incorporated into and compared with a standard 2D clinical routine protocol (Standard). Following informed consent, 20 patients were imaged with both protocols. Datasets were reviewed for image quality using a 5-point Likert scale (0 = non-diagnostic, 4 = excellent) in blinded fashion by two readers. Good image quality with full whole-heart coverage was achieved using the accelerated protocol, particularly for CAI, although significant degradations in quality, as compared with traditional lengthy examinations, were observed for the other image types. Mean total scan time was significantly lower for the Accelerated as compared to Standard protocols (28.99 ± 4.59 min vs. 1.82 ± 0.05 min, P < 0.05). Overall image quality for the Standard vs. Accelerated protocol was 3.67 ± 0.29 vs. 1.5 ± 0.51 (P < 0.005) for PERF, 3.48 ± 0.64 vs. 2.6 ± 0.68 (P < 0.005) for CINE, 2.35 ± 1.01 vs. 2.48 ± 0.68 (P = 0.75) for CAI, and 3.67 ± 0.42 vs. 2.67 ± 0.84 (P < 0.005) for LGE. Diagnostic image quality for Standard vs. Accelerated protocols was 20/20 (100%) vs. 10/20 (50%) for PERF, 20/20 (100%) vs. 18/20 (90%) for CINE, 18/20 (90%) vs. 18/20 (90%) for CAI, and 20/20 (100%) vs. 18/20 (90%) for LGE. This study demonstrates the technical feasibility and promising image quality of 5-minute comprehensive whole-heart cardiac examinations, with simplified scan prescription and high spatial and temporal resolution enabled by highly parallel imaging technology. The study also highlights technical hurdles that remain to be addressed. Although image quality remained diagnostic for most scan types, the reduced image quality of PERF, CINE, and LGE scans in the Accelerated protocol remain a concern. Copyright © 2012 Wiley Periodicals, Inc.

Ensuring Quality in AFRINEST and SATT

PubMed Central

2013-01-01

Background: Three randomized open-label clinical trials [Simplified Antibiotic Therapy Trial (SATT) Bangladesh, SATT Pakistan and African Neonatal Sepsis Trial (AFRINEST)] were developed to test the equivalence of simplified antibiotic regimens compared with the standard regimen of 7 days of parenteral antibiotics. These trials were originally conceived and designed separately; subsequently, significant efforts were made to develop and implement a common protocol and approach. Previous articles in this supplement briefly describe the specific quality control methods used in the individual trials; this article presents additional information about the systematic approaches used to minimize threats to validity and ensure quality across the trials. Methods: A critical component of quality control for AFRINEST and SATT was striving to eliminate variation in clinical assessments and decisions regarding eligibility, enrollment and treatment outcomes. Ensuring appropriate and consistent clinical judgment was accomplished through standardized approaches applied across the trials, including training, assessment of clinical skills and refresher training. Standardized monitoring procedures were also applied across the trials, including routine (day-to-day) internal monitoring of performance and adherence to protocols, systematic external monitoring by funding agencies and external monitoring by experienced, independent trial monitors. A group of independent experts (Technical Steering Committee/Technical Advisory Group) provided regular monitoring and technical oversight for the trials. Conclusions: Harmonization of AFRINEST and SATT have helped to ensure consistency and quality of implementation, both internally and across the trials as a whole, thereby minimizing potential threats to the validity of the trials’ results. PMID:23945575

Using standard treatment protocols to manage costs and quality of hospital services.

PubMed

Meyer, J W; Feingold, M G

1993-06-01

The current health care environment has made it critically important that hospital costs and quality be managed in an integrated fashion. Promised health care reforms are expected to make cost reduction and quality enhancement only more important. Traditional methods of hospital cost and quality control have largely been replaced by such approaches as practice parameters, outcomes measurement, clinical indicators, clinical paths, benchmarking, patient-centered care, and a focus on patient selection criteria. This Special Report describes an integrated process for strategically managing costs and quality simultaneously, incorporating key elements of many important new quality and cost control tools. By using a multidisciplinary group process to develop standard treatment protocols, hospitals and their medical staffs address the most important services provided within major product lines. Using both clinical and financial data, groups of physicians, nurses, department managers, financial analysts, and administrators redesign key patterns of care within their hospital, incorporating the best practices of their own and other institutions. The outcome of this process is a new, standardized set of clinical guidelines that reduce unnecessary variation in care, eliminate redundant interventions, establish clear lines of communication for all caregivers, and reduce the cost of each stay. The hospital, medical staff, and patients benefit from the improved opportunities for managed care contracting, more efficient hospital systems, consensus-based quality measures, and reductions in the cost of care. STPs offer a workable and worthwhile approach to positioning the hospital of the 1990s for operational efficiency and cost and quality competitiveness.

Publication trends of study protocols in rehabilitation.

PubMed

Jesus, Tiago S; Colquhoun, Heather L

2017-09-04

Growing evidence points for the need to publish study protocols in the health field. To observe whether the growing interest in publishing study protocols in the broader health field has been translated into increased publications of rehabilitation study protocols. Observational study using publication data and its indexation in PubMed. Not applicable. Not applicable. PubMed was searched with appropriate combinations of Medical Subject Headings up to December 2014. The effective presence of study protocols was manually screened. Regression models analyzed the yearly growth of publications. Two-sample Z-tests analyzed whether the proportion of Systematic Reviews (SRs) and Randomized Controlled Trials (RCTs) among study protocols differed from that of the same designs for the broader rehabilitation research. Up to December 2014, 746 publications of rehabilitation study protocols were identified, with an exponential growth since 2005 (r2=0.981; p<0.001). RCT protocols were the most common among rehabilitation study protocols (83%), while RCTs were significantly more prevalent among study protocols than among the broader rehabilitation research (83% vs. 35.8%; p<0.001). For SRs, the picture was reversed: significantly less common among study protocols (2.8% vs. 9.3%; p<0.001). Funding was more often reported by rehabilitation study protocols than the broader rehabilitation research (90% vs. 53.1%; p<0.001). Rehabilitation journals published a significantly lower share of rehabilitation study protocols than they did for the broader rehabilitation research (1.8% vs.16.7%; p<0.001). Identifying the reasons for these discrepancies and reverting unwarranted disparities (e.g. low rate of publication for rehabilitation SR protocols) are likely new avenues for rehabilitation research and its publication. SRs, particularly those aggregating RCT results, are considered the best standard of evidence to guide rehabilitation clinical practice; however, that standard can be improved in rigor and/or transparency if the publications of rehabilitation SRs protocols become more common.

SU-C-BRE-01: 3D Conformal Micro Irradiation Results of Four Treatment Sites for Preclinical Small Animal and Clinical Treatment Plans

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

Price, S; Yaddanapudi, S; Rangaraj, D

Purpose: Small animal irradiation can provide preclinical insights necessary for clinical advancement. In order to provide clinically relevant data, these small animal irradiations must be designed such that the treatment methods and results are comparable to clinical protocols, regardless of variations in treatment size and modality. Methods: Small animal treatments for four treatment sites (brain, liver, lung and spine) were investigated, accounting for change in treatment energy and target size. Up to five orthovoltage (300kVp) beams were used in the preclinical treatments, using circular, square, and conformal tungsten apertures, based on the treatment site. Treatments were delivered using the imagemore » guided micro irradiator (microIGRT). The plans were delivered to a mouse sized phantom and dose measurements in axial and coronal planes were performed using radiochromic film. The results of the clinical and preclinical protocols were characterized in terms of conformality number, CTV coverage, dose nonuniformity ratio, and organ at risk sparing. Results: Preclinical small animal treatment conformality was within 1–16% of clinical results for all treatment sites. The volume of the CTV receiving 100% of the prescription dose was typically within 10% of clinical values. The dose non-uniformity was consistently higher for preclinical treatments compared to clinical treatments, indicating hot spots in the target. The ratios of the mean dose in the target to the mean dose in an organ at risk were comparable if not better for preclinical versus clinical treatments. Finally, QUANTEC dose constraints were applied and the recommended morbidity limits were satisfied in each small animal treatment site. Conclusion: We have shown that for four treatment sites, preclinical 3D conformal small animal treatments can be clinically comparable if clinical protocols are followed. Using clinical protocols as the standard, preclinical irradiation methods can be altered and iteratively improved to achieve a clinically relevant irradiation model.« less

A proposed protocol for hand and table sanitizing in chiropractic clinics and education institutions

PubMed Central

Evans, Marion Willard; Ramcharan, Michael; Floyd, Rod; Globe, Gary; Ndetan, Harrison; Williams, Ronald; Ivie, Ronald

2009-01-01

Abstract Objective By nature, chiropractic is a hands-on profession using manipulation applied to the joints with direct skin-to-skin contacts. Chiropractic tables are designed with a face piece to accommodate the prone patient's head in a neutral position and hand rests to allow for relaxed shoulders and upper spine so treatment is facilitated. The purpose of this article is to present a proposed guideline for hand and treatment table surface sanitizing for the chiropractic profession that is evidence-based and can easily be adopted by teaching institutions and doctors in the field. Methods A review of the chiropractic literature demonstrated that pathogenic microbes are present on treatment tables in teaching clinics at multiple facilities, yet no standardized protocols exist in the United States regarding table sanitizing and hand hygiene in chiropractic clinics or education institutions. This article reviews the scientific literature on the subject by using several search engines, databases, and specific reviews of documents pertaining to the topic including existing general guidelines. Results The literature has several existing guidelines that the authors used to develop a proposed protocol for hand and table sanitizing specific to the chiropractic profession. Recommendations were developed and are presented on hand hygiene and table sanitizing procedures that could lower the risk of infection for both clinical personnel and patients in chiropractic facilities. Conclusion This article offers a protocol for hand and table sanitizing in chiropractic clinics and education institutions. The chiropractic profession should consider adoption of these or similar measures and disseminate them to teaching clinics, institutions, and private practitioners. PMID:19646384

Automating individualized coaching and authentic role-play practice for brief intervention training.

PubMed

Hayes-Roth, B; Saker, R; Amano, K

2010-01-01

Brief intervention helps to reduce alcohol abuse, but there is a need for accessible, cost-effective training of clinicians. This study evaluated STAR Workshop , a web-based training system that automates efficacious techniques for individualized coaching and authentic role-play practice. We compared STAR Workshop to a web-based, self-guided e-book and a no-treatment control, for training the Engage for Change (E4C) brief intervention protocol. Subjects were medical and nursing students. Brief written skill probes tested subjects' performance of individual protocol steps, in different clinical scenarios, at three test times: pre-training, post-training, and post-delay (two weeks). Subjects also did live phone interviews with a standardized patient, post-delay. STAR subjects performed significantly better than both other groups. They showed significantly greater improvement from pre-training probes to post-training and post-delay probes. They scored significantly higher on post-delay phone interviews. STAR Workshop appears to be an accessible, cost-effective approach for training students to use the E4C protocol for brief intervention in alcohol abuse. It may also be useful for training other clinical interviewing protocols.

Development and reproducibility evaluation of a Monte Carlo-based standard LINAC model for quality assurance of multi-institutional clinical trials.

PubMed

Usmani, Muhammad Nauman; Takegawa, Hideki; Takashina, Masaaki; Numasaki, Hodaka; Suga, Masaki; Anetai, Yusuke; Kurosu, Keita; Koizumi, Masahiko; Teshima, Teruki

2014-11-01

Technical developments in radiotherapy (RT) have created a need for systematic quality assurance (QA) to ensure that clinical institutions deliver prescribed radiation doses consistent with the requirements of clinical protocols. For QA, an ideal dose verification system should be independent of the treatment-planning system (TPS). This paper describes the development and reproducibility evaluation of a Monte Carlo (MC)-based standard LINAC model as a preliminary requirement for independent verification of dose distributions. The BEAMnrc MC code is used for characterization of the 6-, 10- and 15-MV photon beams for a wide range of field sizes. The modeling of the LINAC head components is based on the specifications provided by the manufacturer. MC dose distributions are tuned to match Varian Golden Beam Data (GBD). For reproducibility evaluation, calculated beam data is compared with beam data measured at individual institutions. For all energies and field sizes, the MC and GBD agreed to within 1.0% for percentage depth doses (PDDs), 1.5% for beam profiles and 1.2% for total scatter factors (Scps.). Reproducibility evaluation showed that the maximum average local differences were 1.3% and 2.5% for PDDs and beam profiles, respectively. MC and institutions' mean Scps agreed to within 2.0%. An MC-based standard LINAC model developed to independently verify dose distributions for QA of multi-institutional clinical trials and routine clinical practice has proven to be highly accurate and reproducible and can thus help ensure that prescribed doses delivered are consistent with the requirements of clinical protocols. © The Author 2014. Published by Oxford University Press on behalf of The Japan Radiation Research Society and Japanese Society for Radiation Oncology.

Validation of mobile eye-tracking as novel and efficient means for differentiating progressive supranuclear palsy from Parkinson's disease

PubMed Central

Marx, Svenja; Respondek, Gesine; Stamelou, Maria; Dowiasch, Stefan; Stoll, Josef; Bremmer, Frank; Oertel, Wolfgang H.; Höglinger, Günter U.; Einhäuser, Wolfgang

2012-01-01

Background: The decreased ability to carry out vertical saccades is a key symptom of Progressive Supranuclear Palsy (PSP). Objective measurement devices can help to reliably detect subtle eye movement disturbances to improve sensitivity and specificity of the clinical diagnosis. The present study aims at transferring findings from restricted stationary video-oculography (VOG) to a wearable head-mounted device, which can be readily applied in clinical practice. Methods: We investigated the eye movements in 10 possible or probable PSP patients, 11 Parkinson's disease (PD) patients, and 10 age-matched healthy controls (HCs) using a mobile, gaze-driven video camera setup (EyeSeeCam). Ocular movements were analyzed during a standardized fixation protocol and in an unrestricted real-life scenario while walking along a corridor. Results: The EyeSeeCam detected prominent impairment of both saccade velocity and amplitude in PSP patients, differentiating them from PD and HCs. Differences were particularly evident for saccades in the vertical plane, and stronger for saccades than for other eye movements. Differences were more pronounced during the standardized protocol than in the real-life scenario. Conclusions: Combined analysis of saccade velocity and saccade amplitude during the fixation protocol with the EyeSeeCam provides a simple, rapid (<20 s), and reliable tool to differentiate clinically established PSP patients from PD and HCs. As such, our findings prepare the ground for using wearable eye-tracking in patients with uncertain diagnoses. PMID:23248593

A vascular laboratory protocol for improving and managing after-hours suspected acute deep venous thrombosis.

PubMed

Martin, Angela H; Eckert, George; Lemmon, Gary W; Sawchuk, Alan; Dalsing, Michael C

2014-04-01

This study reviews the clinical and workforce impact of a suggested protocol designed for the management of suspected acute deep venous thrombosis (DVT) in patients seen after standard vascular laboratory business hours. The protocol included the use of Wells score, D-dimer and a single dose of therapeutic anticoagulant to defer venous duplex ultrasound (VDU) testing until routine business hours unless contraindicated. Information was collected on medical history, physical exam and the timing of any diagnostic studies and treatment provided. Over 15% of studies done after-hours were deemed unnecessary by our protocol and in every individual the results were negative for an acute DVT. There were no adverse events from a one-time dose of anticoagulant. Limiting emergency VDU coverage to evaluate for acute DVT based on a management protocol can eliminate unnecessary after-hours VDU testing without having a negative impact on patient care.

From skin biopsy to neurons through a pluripotent intermediate under Good Manufacturing Practice protocols.

PubMed

Karumbayaram, Saravanan; Lee, Peiyee; Azghadi, Soheila F; Cooper, Aaron R; Patterson, Michaela; Kohn, Donald B; Pyle, April; Clark, Amander; Byrne, James; Zack, Jerome A; Plath, Kathrin; Lowry, William E

2012-01-01

The clinical application of human-induced pluripotent stem cells (hiPSCs) requires not only the production of Good Manufacturing Practice-grade (GMP-grade) hiPSCs but also the derivation of specified cell types for transplantation under GMP conditions. Previous reports have suggested that hiPSCs can be produced in the absence of animal-derived reagents (xenobiotics) to ease the transition to production under GMP standards. However, to facilitate the use of hiPSCs in cell-based therapeutics, their progeny should be produced not only in the absence of xenobiotics but also under GMP conditions requiring extensive standardization of protocols, documentation, and reproducibility of methods and product. Here, we present a successful framework to produce GMP-grade derivatives of hiPSCs that are free of xenobiotic exposure from the collection of patient fibroblasts, through reprogramming, maintenance of hiPSCs, identification of reprogramming vector integration sites (nrLAM-PCR), and finally specification and terminal differentiation of clinically relevant cells. Furthermore, we developed a primary set of Standard Operating Procedures for the GMP-grade derivation and differentiation of these cells as a resource to facilitate widespread adoption of these practices.

Generation of comprehensive thoracic oncology database--tool for translational research.

PubMed

Surati, Mosmi; Robinson, Matthew; Nandi, Suvobroto; Faoro, Leonardo; Demchuk, Carley; Kanteti, Rajani; Ferguson, Benjamin; Gangadhar, Tara; Hensing, Thomas; Hasina, Rifat; Husain, Aliya; Ferguson, Mark; Karrison, Theodore; Salgia, Ravi

2011-01-22

The Thoracic Oncology Program Database Project was created to serve as a comprehensive, verified, and accessible repository for well-annotated cancer specimens and clinical data to be available to researchers within the Thoracic Oncology Research Program. This database also captures a large volume of genomic and proteomic data obtained from various tumor tissue studies. A team of clinical and basic science researchers, a biostatistician, and a bioinformatics expert was convened to design the database. Variables of interest were clearly defined and their descriptions were written within a standard operating manual to ensure consistency of data annotation. Using a protocol for prospective tissue banking and another protocol for retrospective banking, tumor and normal tissue samples from patients consented to these protocols were collected. Clinical information such as demographics, cancer characterization, and treatment plans for these patients were abstracted and entered into an Access database. Proteomic and genomic data have been included in the database and have been linked to clinical information for patients described within the database. The data from each table were linked using the relationships function in Microsoft Access to allow the database manager to connect clinical and laboratory information during a query. The queried data can then be exported for statistical analysis and hypothesis generation.

How do nurses, midwives and health visitors contribute to protocol-based care? A synthesis of the UK literature.

PubMed

Ilott, Irene; Booth, Andrew; Rick, Jo; Patterson, Malcolm

2010-06-01

To explore how nurses, midwives and health visitors contribute to the development, implementation and audit of protocol-based care. Protocol-based care refers to the use of documents that set standards for clinical care processes with the intent of reducing unacceptable variations in practice. Documents such as protocols, clinical guidelines and care pathways underpin evidence-based practice throughout the world. An interpretative review using the five-stage systematic literature review process. The data sources were the British Nursing Index, CINAHL, EMBASE, MEDLINE and Web of Science from onset to 2005. The Journal of Integrated Care Pathways was hand searched (1997-June 2006). Thirty three studies about protocol-based care in the United Kingdom were appraised using the Qualitative Assessment and Review Instrument (QARI version 2). The literature was synthesized inductively and deductively, using an official 12-step guide for development as a framework for the deductive synthesis. Most papers were descriptive, offering practitioner knowledge and positive findings about a locally developed and owned protocol-based care. The majority were instigated in response to clinical need or service re-design. Development of protocol-based care was a non-linear, idiosyncratic process, with steps omitted, repeated or completed in a different order. The context and the multiple purposes of protocol-based care influenced the development process. Implementation and sustainability were rarely mentioned, or theorised as a change. The roles and activities of nurses were so understated as to be almost invisible. There were notable gaps in the literature about the resource use costs, the engagement of patients in the decision-making process, leadership and the impact of formalisation and new roles on inter-professional relations. Documents that standardise clinical care are part of the history of nursing as well as contemporary evidence-based care and expanded roles. Considering the proliferation and contested nature of protocol-based care, the dearth of literature about the contribution, experience and outcomes for nurses, midwives and health visitors is noteworthy and requires further investigation. (c) 2010 Elsevier Ltd. All rights reserved.

Quality control for quantitative multicenter whole-body PET/MR studies: A NEMA image quality phantom study with three current PET/MR systems

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

Boellaard, Ronald, E-mail: r.boellaard@vumc.nl; European Association of Nuclear Medicine Research Ltd., Vienna 1060; European Association of Nuclear Medicine Physics Committee, Vienna 1060

2015-10-15

Purpose: Integrated positron emission tomography/magnetic resonance (PET/MR) systems derive the PET attenuation correction (AC) from dedicated MR sequences. While MR-AC performs reasonably well in clinical patient imaging, it may fail for phantom-based quality control (QC). The authors assess the applicability of different protocols for PET QC in multicenter PET/MR imaging. Methods: The National Electrical Manufacturers Association NU 2 2007 image quality phantom was imaged on three combined PET/MR systems: a Philips Ingenuity TF PET/MR, a Siemens Biograph mMR, and a GE SIGNA PET/MR (prototype) system. The phantom was filled according to the EANM FDG-PET/CT guideline 1.0 and scanned for 5more » min over 1 bed. Two MR-AC imaging protocols were tested: standard clinical procedures and a dedicated protocol for phantom tests. Depending on the system, the dedicated phantom protocol employs a two-class (water and air) segmentation of the MR data or a CT-based template. Differences in attenuation- and SUV recovery coefficients (RC) are reported. PET/CT-based simulations were performed to simulate the various artifacts seen in the AC maps (μ-map) and their impact on the accuracy of phantom-based QC. Results: Clinical MR-AC protocols caused substantial errors and artifacts in the AC maps, resulting in underestimations of the reconstructed PET activity of up to 27%, depending on the PET/MR system. Using dedicated phantom MR-AC protocols, PET bias was reduced to −8%. Mean and max SUV RC met EARL multicenter PET performance specifications for most contrast objects, but only when using the dedicated phantom protocol. Simulations confirmed the bias in experimental data to be caused by incorrect AC maps resulting from the use of clinical MR-AC protocols. Conclusions: Phantom-based quality control of PET/MR systems in a multicenter, multivendor setting may be performed with sufficient accuracy, but only when dedicated phantom acquisition and processing protocols are used for attenuation correction.« less

A standards-based clinical information system for HIV/AIDS.

PubMed

Stitt, F W

1995-01-01

To create a clinical data repository to interface the Veteran's Administration (VA) Decentralized Hospital Computer Program (DHCP) and a departmental clinical information system for the management of HIV patients. This system supports record-keeping, decision-making, reporting, and analysis. The database development was designed to overcome two impediments to successful implementations of clinical databases: (i) lack of a standard reference data model, and; (ii) lack of a universal standard for medical concept representation. Health Level Seven (HL7) is a standard protocol that specifies the implementation of interfaces between two computer applications (sender and receiver) from different vendors or sources of electronic data exchange in the health care environment. This eliminates or substantially reduces the custom interface programming and program maintenance that would otherwise be required. HL7 defines the data to be exchanged, the timing of the interchange, and the communication of errors to the application. The formats are generic in nature and must be configured to meet the needs of the two applications involved. The standard conceptually operates at the seventh level of the ISO model for Open Systems Interconnection (OSI). The OSI simply defines the data elements that are exchanged as abstract messages, and does not prescribe the exact bit stream of the messages that flow over the network. Lower level network software developed according to the OSI model may be used to encode and decode the actual bit stream. The OSI protocols are not universally implemented and, therefore, a set of encoding rules for defining the exact representation of a message must be specified. The VA has created an HL7 module to assist DHCP applications in exchanging health care information with other applications using the HL7 protocol. The DHCP HL7 module consists of a set of utility routines and files that provide a generic interface to the HL7 protocol for all DHCP applications. The VA's DHCP core modules are in standard use at 169 hospitals, and the role of the VA system in health care delivery has been discussed elsewhere. This development was performed at the Miami VA Medical Center Special Immunology Unit, where a database was created for an HIV patient registry in 1987. Over 2,300 patient have been entered into a database that supports a problem-oriented summary of the patient's clinical record. The interface to the VA DHCP was designed and implemented to capture information from the patient treatment file, pharmacy, laboratory, radiology, and other modules. We obtained a suite of programs for implementing the HL7 encoding rules from Columbia-Presbyterian Medical Center in New York, written in ANSI C. This toolkit isolates our application programs from the details of the HL7 encoding rules, and allows them to deal with abstract messages and the programming level. While HL7 has become a standard for healthcare message exchange, SQL (Structured Query Language) is the standard for database definition, data manipulation, and query. The target database (Stitt F.W. The Problem-Oriented Medical Synopsis: a patient-centered clinical information system. Proc 17 SCAMC. 1993:88-93) provides clinical workstation functionality. Medical concepts are encoded using a preferred terminology derived from over 15 sources that include the Unified Medical Language System and SNOMed International ( Stitt F.W. The Problem-Oriented Medical Synopsis: coding, indexing, and classification sub-model. Proc 18 SCAMC, 1994: in press). The databases were modeled using the Information Engineering CASE tools, and were written using relational database utilities, including embedded SQL in C (ESQL/C). We linked ESQL/C programs to the HL7 toolkit to allow data to be inserted, deleted, or updated, under transaction control. A graphical format will be used to display the entity-rel

[Spontaneous positive end-expiratory pressure ventilation in elderly patients with cardiogenic pulmonary edema. Assessment in an emergency admissions unit].

PubMed

L'Her, E; Duquesne, F; Paris, A; Mouline, J; Renault, A; Garo, B; Boles, J M

1998-06-20

Intubation and ventilatory assistance are often required in patients presenting severe hypoxemic respiratory distress, but may be contraindicated in elderly subjects due to an underlying condition. The aim of this study was to assess the feasibility, acceptability and contribution of early assistance with spontaneous positive end-expiratory pressure ventilation for elderly subjects admitted to an emergency unit for acute respiratory distress due to cardiogenic pulmonary edema. In our emergency admission unit, all patients with life-threatening hypoxemic respiratory distress are initially assisted with noninvasive spontaneous positive end-expiratory pressure ventilation using a standardized commercial device. We retrospectively analyzed the the files of all patients aged over 70 years who were treated with this standard protocol for cardiogenic pulmonary edema from April 1996 through September 1997. During the study period, 36 patients aged over 70 years required ventilatory assistance according to the standard protocol. Intubation was not reasonable in most of the patients (n = 30). After 1 hour of ventilation, none of the patients developed clinical signs of life-threatening distress. Blood gases demonstrated improved oxygenation (AEPO2 = +184.9 +/- 105.4 mmHg; p < 0.000001). Thirty-two patients were considered to be cured (88.9%) and were discharged; the cardiovascular condition was fatal in 4 patients (11.1%). The rapid improvement in clinical signs and blood gases as well as the final outcome suggests that early assistance with spontaneous positive end-expiratory pressure ventilation is warranted at admission for elderly patients with respiratory distress due to cardiogenic pulmonary edema. Compared with a control group of hospitalized patients cared for during the preceding year and who were not treated with the standard protocol, we also demonstrated a clear improvement in mortality (11% versus 20%).

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

PubMed

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

2013-05-01

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

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

PubMed Central

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

2013-01-01

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

Fully automated motion correction in first-pass myocardial perfusion MR image sequences.

PubMed

Milles, Julien; van der Geest, Rob J; Jerosch-Herold, Michael; Reiber, Johan H C; Lelieveldt, Boudewijn P F

2008-11-01

This paper presents a novel method for registration of cardiac perfusion magnetic resonance imaging (MRI). The presented method is capable of automatically registering perfusion data, using independent component analysis (ICA) to extract physiologically relevant features together with their time-intensity behavior. A time-varying reference image mimicking intensity changes in the data of interest is computed based on the results of that ICA. This reference image is used in a two-pass registration framework. Qualitative and quantitative validation of the method is carried out using 46 clinical quality, short-axis, perfusion MR datasets comprising 100 images each. Despite varying image quality and motion patterns in the evaluation set, validation of the method showed a reduction of the average right ventricle (LV) motion from 1.26+/-0.87 to 0.64+/-0.46 pixels. Time-intensity curves are also improved after registration with an average error reduced from 2.65+/-7.89% to 0.87+/-3.88% between registered data and manual gold standard. Comparison of clinically relevant parameters computed using registered data and the manual gold standard show a good agreement. Additional tests with a simulated free-breathing protocol showed robustness against considerable deviations from a standard breathing protocol. We conclude that this fully automatic ICA-based method shows an accuracy, a robustness and a computation speed adequate for use in a clinical environment.

Extravasation injuries: current medical and surgical treatment.

PubMed

Doornaert, M; Monstrey, S; Roche, N

2013-01-01

Extravasation is a devastating complication of intravenous therapy that develops when a drug infiltrates the interstitial tissue surrounding the vein. Due to the uncertain and possibly dramatic outcome, early recognition and adequate treatment with the aid of a standardized protocol are needed. A pubmed literature search was conducted and all relevant articles were reviewed for the development of an extravasation treatment protocol. An overview of current treatment guidelines and clinical experience is provided. The extravasation treatment protocol was implied during 1 year in this university hospital with satisfactory outcome. Treatment starts with prevention. In case of an established extravasation injury, early recognition, assessment of severity, and treatment with medical and/or surgical therapies are recommended.

Long-term reproducibility of phantom signal intensities in nonuniformity corrected STIR-MRI examinations of skeletal muscle.

PubMed

Viddeleer, Alain R; Sijens, Paul E; van Ooijen, Peter M A; Kuypers, Paul D L; Hovius, Steven E R; Oudkerk, Matthijs

2009-08-01

Nerve regeneration could be monitored by comparing MRI image intensities in time, as denervated muscles display increased signal intensity in STIR sequences. In this study long-term reproducibility of STIR image intensity was assessed under clinical conditions and the required image intensity nonuniformity correction was improved by using phantom scans obtained at multiple positions. Three-dimensional image intensity nonuniformity was investigated in phantom scans. Next, over a three-year period, 190 clinical STIR hand scans were obtained using a standardized acquisition protocol, and corrected for intensity nonuniformity by using the results of phantom scanning. The results of correction with 1, 3, and 11 phantom scans were compared. The image intensities in calibration tubes close to the hands were measured every time to determine the reproducibility of our method. With calibration, the reproducibility of STIR image intensity improved from 7.8 to 6.4%. Image intensity nonuniformity correction with 11 phantom scans gave significantly better results than correction with 1 or 3 scans. The image intensities in clinical STIR images acquired at different times can be compared directly, provided that the acquisition protocol is standardized and that nonuniformity correction is applied. Nonuniformity correction is preferably based on multiple phantom scans.

Psychotherapy for PTSD: An evidence-based guide to a theranostic approach to treatment.

PubMed

Goodnight, Jessica R M; Ragsdale, Katie A; Rauch, Sheila A M; Rothbaum, Barbara O

2018-05-18

Posttraumatic stress disorder (PTSD) is often a clinically complex disorder, frequently presenting with comorbid clinical conditions. Individuals with PTSD may also present with high-risk symptoms such as substance misuse and suicidal ideation. The clinical complexity of PTSD has precluded some clinicians from providing gold-standard trauma-focused treatment due to concern of iatrogenic effects. However, evidence to date suggests that trauma-focused treatments are safe and effective for PTSD even when higher-risk comorbidity presents. Occasionally, while some patients present with clinical concerns that may benefit from modifications to standard recommended treatment protocols, research suggests there are few absolute contraindications to trauma-focused treatment. The present manuscript provides a review of evidence-based assessment and treatment recommendations for PTSD. A clinical decision-making guide for PTSD across areas of clinical complexity is provided. Copyright © 2018 Elsevier Inc. All rights reserved.

Preventing Epilepsy After Traumatic Brain Injury

DTIC Science & Technology

2008-02-01

early seizures to the standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized clinical trial to...protocol was revised to eliminate several major obstacles. We have enrolled 5 subjects into the study; two in the phenytoin arm, one in the short term...prevent early seizures better than the current standard of care ( phenytoin ). A secondary objective is to obtain the data necessary to design a randomized

Neuropeptide Y stimulation as primary target for preventive measures of maladaptative cardiovascular reactions in occupational chronic stress exposure.

PubMed

Ciumaşu-Rîmbu, Mălina; Popa, Livia; Vulpoi, Carmen

2012-01-01

Chronic stress may produce a decrease in central NPY expression and subjects exposed to it may prove hypersensitivity to a novel stressor with dysfunctions in the NPY system and cardiovascular maladaptation to stress, even hypertension. Upregulation of NPY expression may contribute to successful behavioral adaptation to stress by reducing cardiovascular tone and suppressing anxious behaviors. Adaptogens, a new class of metabolic regulators stimulate NPY expression and release. The aim of this study is to increase tolerance and adaptation to stress of hypersensitive to novel stressor, occupational chronic stress exposed subjects with cardiovascular maladaptation to mild new stressor using adaptogens as part of prevention protocol. 40 military personnel with known cardiostressor reactional mode and occupational chronic stress exposure were exposed to mild novel stressor: occupational medicine routine evaluation and clinically assessed for maladaptative cardiovascular response prior and before application of 30 day prevention protocol. Employees were randomly split in two groups, one receiving standard prevention protocol (lifestyle counseling) plus adaptogens in multiple dose administration, twice daily and the other receiving only standard prevention protocol. We found significant statistic differences in all cardiovascular parameters in adaptogen group and only in diastolic blood pressure in control group. Adaptogens could be an important factor in successful prevention protocols of chronic occupational stress dysfunctions involving NPY systems.

Field validation of protocols developed to evaluate in-line mastitis detection systems.

PubMed

Kamphuis, C; Dela Rue, B T; Eastwood, C R

2016-02-01

This paper reports on a field validation of previously developed protocols for evaluating the performance of in-line mastitis-detection systems. The protocols outlined 2 requirements of these systems: (1) to detect cows with clinical mastitis (CM) promptly and accurately to enable timely and appropriate treatment and (2) to identify cows with high somatic cell count (SCC) to manage bulk milk SCC levels. Gold standard measures, evaluation tests, performance measures, and performance targets were proposed. The current study validated the protocols on commercial dairy farms with automated in-line mastitis-detection systems using both electrical conductivity (EC) and SCC sensor systems that both monitor at whole-udder level. The protocol for requirement 1 was applied on 3 commercial farms. For requirement 2, the protocol was applied on 6 farms; 3 of them had low bulk milk SCC (128×10(3) cells/mL) and were the same farms as used for field evaluation of requirement 1. Three farms with high bulk milk SCC (270×10(3) cells/mL) were additionally enrolled. The field evaluation methodology and results were presented at a workshop including representation from 7 international suppliers of in-line mastitis-detection systems. Feedback was sought on the acceptance of standardized performance evaluation protocols and recommended refinements to the protocols. Although the methodology for requirement 1 was relatively labor intensive and required organizational skills over an extended period, no major issues were encountered during the field validation of both protocols. The validation, thus, proved the protocols to be practical. Also, no changes to the data collection process were recommended by the technology supplier representatives. However, 4 recommendations were made to refine the protocols: inclusion of an additional analysis that ignores small (low-density) clot observations in the definition of CM, extension of the time window from 4 to 5 milkings for timely alerts for CM, setting a maximum number of 10 milkings for the time window to detect a CM episode, and presentation of sensitivity for a larger range of false alerts per 1,000 milkings replacing minimum performance targets. The recommended refinements are discussed with suggested changes to the original protocols. The information presented is intended to inform further debate toward achieving international agreement on standard protocols to evaluate performance of in-line mastitis-detection systems. Copyright © 2016 American Dairy Science Association. Published by Elsevier Inc. All rights reserved.

Response evaluation criteria for solid tumours in dogs (v1.0): a Veterinary Cooperative Oncology Group (VCOG) consensus document.

PubMed

Nguyen, S M; Thamm, D H; Vail, D M; London, C A

2015-09-01

In veterinary medical oncology, there is currently no standardized protocol for assessing response to therapy in solid tumours. The lack of such a formalized guideline makes it challenging to critically compare outcome measures across various treatment protocols. The Veterinary Cooperative Oncology Group (VCOG) membership consensus document presented here is based on the recommendations of a subcommittee of American College of Veterinary Internal Medicine (ACVIM) board-certified veterinary oncologists. This consensus paper has used the human response evaluation criteria in solid tumours (RECIST v1.1) as a framework to establish standard procedures for response assessment in canine solid tumours that is meant to be easy to use, repeatable and applicable across a variety of clinical trial structures in veterinary oncology. It is hoped that this new canine RECIST (cRECIST v1.0) will be adopted within the veterinary oncology community and thereby facilitate the comparison of current and future treatment protocols used for companion animals with cancer. © 2013 Blackwell Publishing Ltd.

Performance of the Colson MAM BP 3AA1-2 automatic blood pressure monitor according to the European Society of Hypertension validation protocol.

PubMed

Pereira, Telmo; Maldonado, João

2005-11-01

To evaluate the performance of the Colson MAM BP 3AA1-2 oscillometric automatic blood pressure monitor according to the validation protocol of the European Society of Hypertension, testing its suitability for self-measurement of blood pressure. The performance of the device was assessed in relation to various clinical variables, including age, gender, body mass index, arm circumference and arterial stiffness. 33 subjects (15 men and 18 women), with a mean age of 47 +/- 10 years, were studied according to the procedures laid down in the European Society of Hypertension validation protocol. Sequential same-arm blood pressure measurements were made, alternating between a mercury standard and the automatic device. The differences among the test-control measurements were assessed and divided into categorization zones of 5, 10 and 15 mmHg discrepancy. Aortic pulse wave velocity was assessed in all subjects with a Complior device (Colson, Paris). The Colson MAM BP 3AA1-2 passed all three phases of the protocol for both systolic and diastolic blood pressure. The mean differences between the test and control measurements were -1.0 +/- 5.0 mmHg for systolic blood pressure and -1.1 +/- 4.1 mmHg for diastolic blood pressure. Both standard deviations are well below the 8 mmHg limit proposed by the Association for the Advancement of Medical Instrumentation. The predictive value of various clinical variables for the discrepancies was assessed by a regression model analysis, with no variable being found that independently undermined the performance of the monitor. In another regression analysis, we found a similar relation between test and control blood pressures and aortic pulse wave velocity, a widely recognized and validated index of target organ damage. These data show that the Colson MAM BP 3AA1-2 satisfies the quality requirements proposed by the European Society of Hypertension, demonstrating its suitability for inclusion in integrated programs of clinical surveillance based on self-measurement of blood pressure. The uniformity of its performance over a wide spectrum of clinical characteristics and the relation found with pulse wave velocity further reinforce its clinical validity.

Clinical and economic impact of infliximab one-hour infusion protocol in patients with inflammatory bowel diseases: A multicenter study

PubMed Central

Viola, Anna; Costantino, Giuseppe; Privitera, Antonino Carlo; Bossa, Fabrizio; Lauria, Angelo; Grossi, Laurino; Principi, Maria Beatrice; Della Valle, Nicola; Cappello, Maria

2017-01-01

AIM To assess the impact of short infliximab (IFX) infusion on hospital resource utilization and costs. METHODS All inflammatory bowel diseases (IBD) patients who received IFX 1 h infusion from March 2007 to September 2014 in eight centers from Southern Italy were included in the analysis. Demographic, clinical and infusion related data were collected. The potential benefits related to the short infusion protocol were assessed both in terms of time saving and increased infusion unit capacity. In addition, indirect patient-related cost savings were evaluated. RESULTS One hundred and twenty-five patients were recruited (64 with ulcerative colitis and 61 with Crohn’s disease). Median duration of disease was of 53 mo and mean age of pts at diagnosis was of 34 years (SD: ± 13). Adverse infusion reactions were reported in less than 4% both before and after short infusion. The total number of infusions across the selected centers was of 2501 (30.5% short infusions). In the analyzed cohort, 1143 h were saved (762 in the infusion and 381 in observation phases) through the rapid IFX infusion protocol. This time saving (-15% compared to the standard protocol in infusion phase) represents, from the hospital perspective, an opportunity to optimize infusion unit capacity by allocating the saved time in alternative cost-effective treatments. This is the case of opportunity cost that represents the value of forgone benefit which could be obtained from a resource in its next-best alternative use. Hence, an extra hour of infusion in the case of standard 2-h IFX represents a loss in opportunity to provide other cost effective services. The analysis showed that the short infusion increased the infusion units capacity up to 50% on days when the IFX infusions were scheduled (infusion phase). Furthermore, the analysis showed that the short IFX infusion protocol leads to time savings also in the post-infusion phase (observation) leading to a time saving of 10% on average among the analyzed centers. Finally, the short infusion protocol has been demonstrated to lead to indirect cost savings of €138/patient (average -€17.300 on the whole cohort). CONCLUSION A short IFX infusion protocol can be considered time and cost saving in comparison to the standard infusion protocol both from the hospital’s perspective, as it contributes to increase infusion units capacity, and the patients’ perspective, as it reduces indirect costs and the impact of treatment on everyday life and work productivity. PMID:28533923

Comparison of eye lens dose on neuroimaging protocols between 16- and 64-section multidetector CT: achieving the lowest possible dose.

PubMed

Tan, J S P; Tan, K-L; Lee, J C L; Wan, C-M; Leong, J-L; Chan, L-L

2009-02-01

To our knowledge, there has been no study that compares the radiation dose delivered to the eye lens by 16- and 64-section multidetector CT (MDCT) for standard clinical neuroimaging protocols. Our aim was to assess radiation-dose differences between 16- and 64-section MDCT from the same manufacturer, by using near-identical neuroimaging protocols. Three cadaveric heads were scanned on 16- and 64-section MDCT by using standard neuroimaging CT protocols. Eye lens dose was measured by using thermoluminescent dosimeters (TLD), and each scanning was repeated to reduce random error. The dose-length product, volume CT dose index (CTDI(vol)), and TLD readings for each imaging protocol were averaged and compared between scanners and protocols, by using the paired Student t test. Statistical significance was defined at P < .05. The radiation dose delivered and eye lens doses were lower by 28.1%-45.7% (P < .000) on the 64-section MDCT for near-identical imaging protocols. On the 16-section MDCT, lens dose reduction was greatest (81.1%) on a tilted axial mode, compared with a nontilted helical mode for CT brain scans. Among the protocols studied, CT of the temporal bone delivered the greatest radiation dose to the eye lens. Eye lens radiation doses delivered by the 64-section MDCT are significantly lower, partly due to improvements in automatic tube current modulation technology. However, where applicable, protection of the eyes from the radiation beam by either repositioning the head or tilting the gantry remains the best way to reduce eye lens dose.

10 CFR 712.38 - Maintenance of medical records.

Code of Federal Regulations, 2010 CFR

2010-01-01

... 10 Energy 4 2010-01-01 2010-01-01 false Maintenance of medical records. 712.38 Section 712.38 Energy DEPARTMENT OF ENERGY HUMAN RELIABILITY PROGRAM Medical Standards § 712.38 Maintenance of medical... medical record. The psychological record must: (1) Contain any clinical reports, test protocols and data...

Development of Medical Technology for Contingency Response to Marrow Toxic Agents

DTIC Science & Technology

2013-10-30

under the following clinical trial protocol: o S1203: A Randomized Phase III Study of Standard Cytarabine plus Daunorubicin (7+3) Therapy or Idarubicin...with High Dose Cytarabine (IA) versus IA with Vorinostat (IA+V) in Younger Patients with Previously Untreated Acute Myeloid Leukemia (AML) o

Quality: performance improvement, teamwork, information technology and protocols.

PubMed

Coleman, Nana E; Pon, Steven

2013-04-01

Using the Institute of Medicine framework that outlines the domains of quality, this article considers four key aspects of health care delivery which have the potential to significantly affect the quality of health care within the pediatric intensive care unit. The discussion covers: performance improvement and how existing methods for reporting, review, and analysis of medical error relate to patient care; team composition and workflow; and the impact of information technologies on clinical practice. Also considered is how protocol-driven and standardized practice affects both patients and the fiscal interests of the health care system.

Improving the accuracy of blood pressure measurement: the influence of the European Society of Hypertension International Protocol (ESH-IP) for the validation of blood pressure measuring devices and future perspectives.

PubMed

Stergiou, George S; Asmar, Roland; Myers, Martin; Palatini, Paolo; Parati, Gianfranco; Shennan, Andrew; Wang, Jiguang; O'Brien, Eoin

2018-03-01

The European Society of Hypertension (ESH) International Protocol (ESH-IP) for the validation of blood pressure (BP) measuring devices was published in 2002, with the main objective of simplifying the validation procedures, so that more BP monitors would be subjected to independent validation. This article provides an overview of the international impact of the ESH-IP and of the lessons learned from its use, to be able to justify further developments in validation protocols. A review of published (PubMed) validation studies from 2002 to 2017 was performed. One hundred and seventy-seven validation studies using the ESH-IP, 59 using the British Hypertension Society protocol, 46 using the Association for the Advancement of Medical Instrumentation (AAMI) standard and 23 using the International Organization for Standardization (ISO) standard were identified. Lists of validated office-clinic, home and ambulatory BP monitors are provided. Of the ESH-IP studies, 93% tested oscillometric devices, 80% upper arm, 71% home, 25% office and 7% ambulatory monitors (some had more than one function). The original goal of the ESH-IP has been fulfilled in that in the last decade the number of published validation studies has more than doubled. It is now recognized that the provision of accurate devices would be best served by having a universal protocol. An international initiative has been put in place by AAMI, ESH and ISO experts aiming to reach consensus for a universal validation protocol to be accepted worldwide, which will allow a more thorough evaluation of the accuracy and performance of future BP monitors.

Efficacy of right unilateral ultrabrief pulse width ECT: a preliminary report.

PubMed

Magid, Michelle; Truong, Liz; Trevino, Kenneth; Husain, Mustafa

2013-12-01

Ultrabrief (right unilateral) electroconvulsive therapy (UB-RU ECT) is a newer form of ECT, which uses a shorter pulse width than the standard ECT (0.3 vs 1.0 millisecond, respectively). As a result, the use of UB ECT may provide a means of further decreasing ECT-related cognitive adverse effects. In 2011, the University of Texas Southwestern Department of ECT in Austin adopted a UB ECT protocol. The purpose of this study was to perform a preliminary evaluation of the effectiveness and efficiency of UB-RU ECT. This study also examined whether sex, age, or diagnosis affected response rates. This retrospective chart review identified 62 patients treated with the UB ECT protocol. An analysis of ECT response rates and demographic characteristics was conducted based on the data from clinical evaluations and Patient Health Questionnaire 9. Sixty-eight percent of patients in the study responded to ECT; 55% responded to UB pulse width RU ECT with another 13% responding when switched to standard pulse width bilateral ECT. The mean number of treatments in an index ECT series was 12.5. There was no statistically significant difference in response rates between bipolar and unipolar depressed patients. Men required progression to bilateral treatment more than women. This UB ECT protocol demonstrated a similar response rate when compared to standard ECT protocols; however, an increase in the number of treatments was required. Ultrabrief protocols are a viable option for both bipolar and unipolar depression. In men, UB ECT protocols may be less advantageous due to a need to overcome a potentially higher seizure threshold in men; however, additional research is needed to confirm this finding.

Security and Privacy in a DACS.

PubMed

Delgado, Jaime; Llorente, Silvia; Pàmies, Martí; Vilalta, Josep

2016-01-01

The management of electronic health records (EHR), in general, and clinical documents, in particular, is becoming a key issue in the daily work of Healthcare Organizations (HO). The need for providing secure and private access to, and storage for, clinical documents together with the need for HO to interoperate, raises a number of issues difficult to solve. Many systems are in place to manage EHR and documents. Some of these Healthcare Information Systems (HIS) follow standards in their document structure and communications protocols, but many do not. In fact, they are mostly proprietary and do not interoperate. Our proposal to solve the current situation is the use of a DACS (Document Archiving and Communication System) for providing security, privacy and standardized access to clinical documents.

Pelvic Muscle Rehabilitation: A Standardized Protocol for Pelvic Floor Dysfunction

PubMed Central

Pedraza, Rodrigo; Nieto, Javier; Ibarra, Sergio; Haas, Eric M.

2014-01-01

Introduction. Pelvic floor dysfunction syndromes present with voiding, sexual, and anorectal disturbances, which may be associated with one another, resulting in complex presentation. Thus, an integrated diagnosis and management approach may be required. Pelvic muscle rehabilitation (PMR) is a noninvasive modality involving cognitive reeducation, modification, and retraining of the pelvic floor and associated musculature. We describe our standardized PMR protocol for the management of pelvic floor dysfunction syndromes. Pelvic Muscle Rehabilitation Program. The diagnostic assessment includes electromyography and manometry analyzed in 4 phases: (1) initial baseline phase; (2) rapid contraction phase; (3) tonic contraction and endurance phase; and (4) late baseline phase. This evaluation is performed at the onset of every session. PMR management consists of 6 possible therapeutic modalities, employed depending on the diagnostic evaluation: (1) down-training; (2) accessory muscle isolation; (3) discrimination training; (4) muscle strengthening; (5) endurance training; and (6) electrical stimulation. Eight to ten sessions are performed at one-week intervals with integration of home exercises and lifestyle modifications. Conclusions. The PMR protocol offers a standardized approach to diagnose and manage pelvic floor dysfunction syndromes with potential advantages over traditional biofeedback, involving additional interventions and a continuous pelvic floor assessment with management modifications over the clinical course. PMID:25006337

Implementation of a Rapid, Protocol-based TIA Management Pathway.

PubMed

Jarhult, Susann J; Howell, Melissa L; Barnaure-Nachbar, Isabelle; Chang, Yuchiao; White, Benjamin A; Amatangelo, Mary; Brown, David F; Singhal, Aneesh B; Schwamm, Lee H; Silverman, Scott B; Goldstein, Joshua N

2018-03-01

Our goal was to assess whether use of a standardized clinical protocol improves efficiency for patients who present to the emergency department (ED) with symptoms of transient ischemic attack (TIA). We performed a structured, retrospective, cohort study at a large, urban, tertiary care academic center. In July 2012 this hospital implemented a standardized protocol for patients with suspected TIA. The protocol selected high-risk patients for admission and low/intermediate-risk patients to an ED observation unit for workup. Recommended workup included brain imaging, vascular imaging, cardiac monitoring, and observation. Patients were included if clinical providers determined the need for workup for TIA. We included consecutive patients presenting during a six-month period prior to protocol implementation, and those presenting between 6-12 months after implementation. Outcomes included ED length of stay (LOS), hospital LOS, use of neuroimaging, and 90-day risk of stroke or TIA. From 01/2012 to 06/2012, 130 patients were evaluated for TIA symptoms in the ED, and from 01/2013 to 06/2013, 150 patients. The final diagnosis was TIA or stroke in 45% before vs. 41% after (p=0.18). Following the intervention, the inpatient admission rate decreased from 62% to 24% (p<0.001), median ED LOS decreased by 1.2 hours (5.7 to 4.9 hours, p=0.027), and median total hospital LOS from 29.4 hours to 23.1 hours (p=0.019). The proportion of patients receiving head computed tomography (CT) went from 68% to 58% (p=0.087); brain magnetic resonance (MR) imaging from 83% to 88%, (p=0.44) neck CT angiography from 32% to 22% (p=0.039); and neck MR angiography from 61% to 72% (p=0.046). Ninety-day stroke or recurrent TIA among those with final diagnosis of TIA was 3% for both periods. Implementation of a TIA protocol significantly reduced ED LOS and total hospital LOS.

Targeted full energy and protein delivery in critically ill patients: a study protocol for a pilot randomised control trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa; Knight, Laura D; Rechnitzer, Thomas; Forsyth, Adrienne; Mourtzakis, Marina; Presneill, Jeffrey; MacIsaac, Christopher

2018-01-01

Current guidelines for the provision of protein for critically ill patients are based on incomplete evidence, due to limited data from randomised controlled trials. The present pilot randomised controlled trial is part of a program of work to expand knowledge about the clinical effects of protein delivery to critically ill patients. The primary aim of this pilot study is to determine whether an enteral feeding protocol using a volume target, with additional protein supplementation, delivers a greater amount of protein and energy to mechanically ventilated critically ill patients than a standard nutrition protocol. The secondary aims are to evaluate the potential effects of this feeding strategy on muscle mass and other patient-centred outcomes. This prospective, single-centred, pilot, randomised control trial will include 60 participants who are mechanically ventilated and can be enterally fed. Following informed consent, the participants receiving enteral nutrition in the intensive care unit (ICU) will be allocated using a randomisation algorithm in a 1:1 ratio to the intervention (high-protein daily volume-based feeding protocol, providing 25 kcal/kg and 1.5 g/kg protein) or standard care (hourly rate-based feeding protocol providing 25 kcal/kg and 1 g/kg protein). The co-primary outcomes are the average daily protein and energy delivered to the end of day 15 following randomisation. The secondary outcomes include change in quadriceps muscle layer thickness (QMLT) from baseline (prior to randomisation) to ICU discharge and other nutritional and patient-centred outcomes. This trial aims to examine whether a volume-based feeding protocol with supplemental protein increases protein and energy delivery. The potential effect of such increases on muscle mass loss will be explored. These outcomes will assist in formulating larger randomised control trials to assess mortality and morbidity. Australian New Zealand Clinical Trials Registry (ANZCTR), ACTRN: 12615000876594 UTN: U1111-1172-8563.

Clinical Trials Network / Building Infrastructure to Accelerate Transfer of Basic Research in Spinal Cord Injury (SCI) to Clinical Practice

DTIC Science & Technology

2015-05-01

Glasgow Coma Scale (GCS) and of associated injuries with the Abbreviated Injury Scale . The American Spinal Injury Association impairment scale (AIS) is...registry protocol includes: the AIS Impairment Scale , and where appropriate, the Functional Independence Measure FIM™, the Spinal Cord Independence...have been achieved with the registry. Enrollment of 762 participants has demonstrated that is feasible to acquire prospective standardized research

[Clinical studies in health workers employed in the manual lifting of patients: methods for the examination of spinal lesions].

PubMed

Ricci, M G; Menoni, O; Colombini, D; Occhipinti, E

1999-01-01

To enable different research groups to make a standardized collection of clinical data on alterations of the lumbar region of the spine, protocols were used for the collection and classification of data that were proposed and thoroughly validated by the authors. The protocols include a clinical/functional examination of the spine, checking for positive anamnestic threshold, for pain on pressure/palpation of the spiny apophyses and paravertebral muscles, for painful movements, in order to classify 1st, 2nd and 3rd grade functional spondylarthropathy (for different regions of the spine). An ad hoc questionnaire was also prepared for the quantitative and qualitative study of true acute low back pain and the ingravescent low back pain controlled at the onset pharmacologically. The results of this questionnaire make it possible to calculate the incidence of acute low back pain (true and pharmacologically controlled).

Safety and efficacy of collagen crosslinking for the treatment of keratoconus.

PubMed

Kolli, Sai; Aslanides, Ioannis M

2010-11-01

Keratoconus is a condition that causes corneal ectasia and reduced vision in young adults. A proportion of these patients have progressive disease requiring corneal transplantation. A revolutionary new treatment that is purported to halt progression of keratoconus, known as collagen crosslinking (CXL), has recently been introduced into clinical practice. CXL involves the treatment of the cornea with riboflavin followed by photoactivation with UVA light leading to corneal strengthening. This article reviews the basic science, clinical protocols, safety aspects and clinical results of CXL. The reader will gain a comprehensive understanding of: i) the basic science of CXL; ii) the optimised protocols for clinical use of CXL; iii) the results of all the main clinical trials in the literature; iv) contraindications to treatment and v) full clinical safety profile of CXL. CXL represents a new treatment that uniquely allows the halt of progression of keratoconus, thus preventing visual loss and the need for surgical intervention. Available data suggest that this treatment has high efficacy and is very safe and may represent the future standard treatment for progressive keratoconus.

Surgical Process Improvement: Impact of a Standardized Care Model With Electronic Decision Support to Improve Compliance With SCIP Inf-9.

PubMed

Cook, David J; Thompson, Jeffrey E; Suri, Rakesh; Prinsen, Sharon K

2014-01-01

The absence of standardization in surgical care process, exemplified in a "solution shop" model, can lead to unwarranted variation, increased cost, and reduced quality. A comprehensive effort was undertaken to improve quality of care around indwelling bladder catheter use following surgery by creating a "focused factory" model within the cardiac surgical practice. Baseline compliance with Surgical Care Improvement Inf-9, removal of urinary catheter by the end of surgical postoperative day 2, was determined. Comparison of baseline data to postintervention results showed clinically important reductions in the duration of indwelling bladder catheters as well as marked reduction in practice variation. Following the intervention, Surgical Care Improvement Inf-9 guidelines were met in 97% of patients. Although clinical quality improvement was notable, the process to accomplish this-identification of patients suitable for standardized pathways, protocol application, and electronic systems to support the standardized practice model-has potentially greater relevance than the specific clinical results. © 2013 by the American College of Medical Quality.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study

PubMed Central

2014-01-01

Background Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. Methods/Design Prospective observational study with two consecutive cohorts of patients. Setting: A high-volume, academic, supra-regional trauma centre in Germany. Study population: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call. Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. Data: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. Main outcomes: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients’ safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). Analysis: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. Discussion Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. Trial registration Current Controlled Trials ISRCTN74557102. PMID:24589310

Porcelain surface conditioning protocols and shear bond strength of orthodontic brackets.

PubMed

Lestrade, Ashley M; Ballard, Richard W; Xu, Xiaoming; Yu, Qingzhao; Kee, Edwin L; Armbruster, Paul C

2016-05-01

The objective of the present study was to determine which of six bonding protocols yielded a clinically acceptable shear bond strength (SBS) of metal orthodontic brackets to CAD/CAM lithium disilicate porcelain restorations. A secondary aim was to determine which bonding protocol produced the least surface damage at debond. Sixty lithium disilicate samples were fabricated to replicate the facial surface of a mandibular first molar using a CEREC CAD/CAM machine. The samples were split into six test groups, each of which received different mechanical/chemical pretreatment protocols to roughen the porcelain surface prior to bonding a molar orthodontic attachment. Shear bond strength testing was conducted using an Instron machine. The mean, maximum, minimal, and standard deviation SBS values for each sample group including an enamel control were calculated. A t-test was used to evaluate the statistical significance between the groups. No significant differences were found in SBS values, with the exception of surface roughening with a green stone prior to HFA and silane treatment. This protocol yielded slightly higher bond strength which was statistically significant. Chemical treatment alone with HFA/silane yielded SBS values within an acceptable clinical range to withstand forces applied by orthodontic treatment and potentially eliminates the need to mechanically roughen the ceramic surface.

The limits of evidence in drug approval and availability: a case study of cilostazol and naftidrofuryl for the treatment of intermittent claudication.

PubMed

Hong, Haeyeon; Mackey, William C

2014-08-01

Despite numerous efforts to develop effective medications for the treatment of intermittent claudication (IC) over the past 4 decades, a gold standard medical management option has yet to be defined. Although not life-threatening, IC interferes with mobility and activities of daily living, significantly impairing quality of life and potentially causing depression. Cilostazol, the leading pharmacologic agent for IC in the United States, was approved by the US Food and Drug Administration (FDA) in 1999 based on controversial data. Meanwhile, naftidrofuryl, the first-line pharmacologic agent for IC in the United Kingdom and Europe, has never been approved by the FDA and therefore is not available in the United States. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect impossible. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted, because the manufacturers of these agents have much to lose and little to gain from such a study. This article provides an overview of the pharmacology of cilostazol and naftidrofuryl, and the clinical studies leading to their approval and clinical acceptance. It further explores the possible sources of bias in analyzing these clinical trials, some of which have been brought to light by the National Institute for Health and Clinical Excellence (NICE) of the United Kingdom in its technology appraisal guidance. It also speculates the ways in which economic incentives may affect drug-marketing decisions. A literature review of pharmacology and clinical trials for cilostazol and naftidrofuryl was performed in PubMed. The majority of included clinical trials were initially identified through the most recent Cochrane review articles as well as the FDA's approval packet for cilostazol. The technology appraisal guidance of the National Institute for Health and Care Excellence of the United Kingdom and the manufacturer's response to this guidance document were located via an online search engine. The clinical data for cilostazol and naftidrofuryl are plagued by flaws related to lack of protocol standardization, objective endpoints, and strict eligibility criteria in study subjects, making identification of a true treatment effect difficult. Furthermore, no prospective randomized trial comparing the efficacy of cilostazol and naftidrofuryl has been conducted. The history of the evaluation, approval, and marketing of these drugs illustrates the limitations of data in the regulatory approval and marketing of agents whose benefit is subjective and difficult to quantify. Implementation of a standardized protocol with strict eligibility criteria, objective quantifiable measurement of drug effect, and validated endpoints will eventually allow development of an ideal pharmacotherapy for IC. Copyright © 2014 Elsevier HS Journals, Inc. All rights reserved.

Do we need 3D tube current modulation information for accurate organ dosimetry in chest CT? Protocols dose comparisons.

PubMed

Lopez-Rendon, Xochitl; Zhang, Guozhi; Coudyzer, Walter; Develter, Wim; Bosmans, Hilde; Zanca, Federica

2017-11-01

To compare the lung and breast dose associated with three chest protocols: standard, organ-based tube current modulation (OBTCM) and fast-speed scanning; and to estimate the error associated with organ dose when modelling the longitudinal (z-) TCM versus the 3D-TCM in Monte Carlo simulations (MC) for these three protocols. Five adult and three paediatric cadavers with different BMI were scanned. The CTDI vol of the OBTCM and the fast-speed protocols were matched to the patient-specific CTDI vol of the standard protocol. Lung and breast doses were estimated using MC with both z- and 3D-TCM simulated and compared between protocols. The fast-speed scanning protocol delivered the highest doses. A slight reduction for breast dose (up to 5.1%) was observed for two of the three female cadavers with the OBTCM in comparison to the standard. For both adult and paediatric, the implementation of the z-TCM data only for organ dose estimation resulted in 10.0% accuracy for the standard and fast-speed protocols, while relative dose differences were up to 15.3% for the OBTCM protocol. At identical CTDI vol values, the standard protocol delivered the lowest overall doses. Only for the OBTCM protocol is the 3D-TCM needed if an accurate (<10.0%) organ dosimetry is desired. • The z-TCM information is sufficient for accurate dosimetry for standard protocols. • The z-TCM information is sufficient for accurate dosimetry for fast-speed scanning protocols. • For organ-based TCM schemes, the 3D-TCM information is necessary for accurate dosimetry. • At identical CTDI vol , the fast-speed scanning protocol delivered the highest doses. • Lung dose was higher in XCare than standard protocol at identical CTDI vol .

Normalization of cortical thickness measurements across different T1 magnetic resonance imaging protocols by novel W-Score standardization.

PubMed

Chung, Jinyong; Yoo, Kwangsun; Lee, Peter; Kim, Chan Mi; Roh, Jee Hoon; Park, Ji Eun; Kim, Sang Joon; Seo, Sang Won; Shin, Jeong-Hyeon; Seong, Joon-Kyung; Jeong, Yong

2017-10-01

The use of different 3D T1-weighted magnetic resonance (T1 MR) imaging protocols induces image incompatibility across multicenter studies, negating the many advantages of multicenter studies. A few methods have been developed to address this problem, but significant image incompatibility still remains. Thus, we developed a novel and convenient method to improve image compatibility. W-score standardization creates quality reference values by using a healthy group to obtain normalized disease values. We developed a protocol-specific w-score standardization to control the protocol effect, which is applied to each protocol separately. We used three data sets. In dataset 1, brain T1 MR images of normal controls (NC) and patients with Alzheimer's disease (AD) from two centers, acquired with different T1 MR protocols, were used (Protocol 1 and 2, n = 45/group). In dataset 2, data from six subjects, who underwent MRI with two different protocols (Protocol 1 and 2), were used with different repetition times, echo times, and slice thicknesses. In dataset 3, T1 MR images from a large number of healthy normal controls (Protocol 1: n = 148, Protocol 2: n = 343) were collected for w-score standardization. The protocol effect and disease effect on subjects' cortical thickness were analyzed before and after the application of protocol-specific w-score standardization. As expected, different protocols resulted in differing cortical thickness measurements in both NC and AD subjects. Different measurements were obtained for the same subject when imaged with different protocols. Multivariate pattern difference between measurements was observed between the protocols. Classification accuracy between two protocols was nearly 90%. After applying protocol-specific w-score standardization, the differences between the protocols substantially decreased. Most importantly, protocol-specific w-score standardization reduced both univariate and multivariate differences in the images while maintaining the AD disease effect. Compared to conventional regression methods, our method showed the best performance for in terms of controlling the protocol effect while preserving disease information. Protocol-specific w-score standardization effectively resolved the concerns of conventional regression methods. It showed the best performance for improving the compatibility of a T1 MR post-processed feature, cortical thickness. Copyright © 2017 Elsevier Inc. All rights reserved.

Protocol for the management of psychiatric patients with psychomotor agitation.

PubMed

Vieta, Eduard; Garriga, Marina; Cardete, Laura; Bernardo, Miquel; Lombraña, María; Blanch, Jordi; Catalán, Rosa; Vázquez, Mireia; Soler, Victòria; Ortuño, Noélia; Martínez-Arán, Anabel

2017-09-08

Psychomotor agitation (PMA) is a state of motor restlessness and mental tension that requires prompt recognition, appropriate assessment and management to minimize anxiety for the patient and reduce the risk for escalation to aggression and violence. Standardized and applicable protocols and algorithms can assist healthcare providers to identify patients at risk of PMA, achieve timely diagnosis and implement minimally invasive management strategies to ensure patient and staff safety and resolution of the episode. Spanish experts in PMA from different disciplines (psychiatrists, psychologists and nurses) convened in Barcelona for a meeting in April 2016. Based on recently issued international consensus guidelines on the standard of care for psychiatric patients with PMA, the meeting provided the opportunity to address the complexities in the assessment and management of PMA from different perspectives. The attendees worked towards producing a consensus for a unified approach to PMA according to the local standards of care and current local legislations. The draft protocol developed was reviewed and ratified by all members of the panel prior to its presentation to the Catalan Society of Psychiatry and Mental Health, the Spanish Society of Biological Psychiatry (SEPB) and the Spanish Network Centre for Research in Mental Health (CIBERSAM) for input. The final protocol and algorithms were then submitted to these organizations for endorsement. The protocol presented here provides guidance on the appropriate selection and use of pharmacological agents (inhaled/oral/IM), seclusion, and physical restraint for psychiatric patients suspected of or presenting with PMA. The protocol is applicable within the Spanish healthcare system. Implementation of the protocol and the constituent algorithms described here should ensure the best standard of care of patients at risk of PMA. Episodes of PMA could be identified earlier in their clinical course and patients could be managed in the least invasive and coercive manner, ensuring their own safety and that of others around them. Establishing specialized teams in agitation and providing them with continued training on the identification of agitation, patient management and therapeutic alternatives might reduce the burden of PMA for both the patient and the healthcare system.

DXA in the assessment of subchondral bone mineral density in knee osteoarthritis--A semi-standardized protocol after systematic review.

PubMed

Sepriano, Alexandre; Roman-Blas, Jorge A; Little, Robert D; Pimentel-Santos, Fernando; Arribas, Jose María; Largo, Raquel; Branco, Jaime C; Herrero-Beaumont, Gabriel

2015-12-01

Subchondral bone mineral density (sBMD) contributes to the initiation and progression of knee osteoarthritis (OA). Reliable methods to assess sBMD status may predict the response of specific OA phenotypes to targeted therapies. While dual-energy X-ray absorptiometry (DXA) of the knee can determine sBMD, no consensus exists regarding its methodology. Construct a semi-standardized protocol for knee DXA to measure sBMD in patients with OA of the knee by evaluating the varying methodologies present in existing literature. We performed a systematic review of original papers published in PubMed and Web of Science from their inception to July 2014 using the following search terms: subchondral bone, osteoarthritis, and bone mineral density. DXA of the knee can be performed with similar reproducibility values to those proposed by the International Society for Clinical Densitometry for the hip and spine. We identified acquisition view, hip rotation, knee positioning and stabilization, ROI location and definition, and the type of analysis software as important sources of variation. A proposed knee DXA protocol was constructed taking into consideration the results of the review. DXA of the knee can be reliably performed in patients with knee OA. Nevertheless, we found substantial methodological variation across previous studies. Methodological standardization may provide a foundation from which to establish DXA of the knee as a valid tool for identification of SB changes and as an outcome measure in clinical trials of disease modifying osteoarthritic drugs. Copyright © 2015 Elsevier Inc. All rights reserved.

Polyethylene glycol 3350 based colon cleaning protocol: 2 d vs 4 d head to head comparison.

PubMed

Elitsur, Rotem; Butcher, Lisa; Vicki, Lund; Elitsur, Yoram

2013-04-16

To compare between 2 and 4 d colon cleansing protocols. Children who were scheduled for colonoscopy procedure (2010-2012) for various medical reasons, were recruited from the pediatric gastroenterology clinic at Marshall University School of Medicine, Huntington, WV. Exclusion criteria were patients who were allergic to the medication used in the protocols [polyethylene glycol (PEG) 3350, Bisacodyl], or children with metabolic or renal diseases. Two PEG 3350 protocols for 4 d (A) and 2 d (B) were prescribed as previously described. A questionnaire describing the volume of PEG consumed, clinical data, and side effects were recorded. Colon preparation was graded by two observers according to previously described method. Rate of adequate colon preparation. A total of 78 patients were considered for final calculation (group A: 40, group B: 38). Age and stool consistency at the last day was comparable in both groups, but the number of stools/day was significantly higher in group B (P = 0.001). Adequate colon preparation was reached in 57.5% (A) and 73.6% (B), respectively (P = 0.206). Side effects were minimal and comparable in both groups. There was no difference in children's age, stool characteristics, or side effects between the children with adequate or inadequate colon preparation. Correlation and agreement between observers was excellent (Pearson correlation = 0.972, kappa = 1.0). No difference between protocols was observed, but the 2 d protocol was superior for its shorter time. Direct comparison between different colon cleansing protocols is crucial in order to establish the "gold standard" protocol for children.

Portfolio of prospective clinical trials including brachytherapy: an analysis of the ClinicalTrials.gov database.

PubMed

Cihoric, Nikola; Tsikkinis, Alexandros; Miguelez, Cristina Gutierrez; Strnad, Vratislav; Soldatovic, Ivan; Ghadjar, Pirus; Jeremic, Branislav; Dal Pra, Alan; Aebersold, Daniel M; Lössl, Kristina

2016-03-22

To evaluate the current status of prospective interventional clinical trials that includes brachytherapy (BT) procedures. The records of 175,538 (100 %) clinical trials registered at ClinicalTrials.gov were downloaded on September 2014 and a database was established. Trials using BT as an intervention were identified for further analyses. The selected trials were manually categorized according to indication(s), BT source, applied dose rate, primary sponsor type, location, protocol initiator and funding source. We analyzed trials across 8 available trial protocol elements registered within the database. In total 245 clinical trials were identified, 147 with BT as primary investigated treatment modality and 98 that included BT as an optional treatment component or as part of the standard treatment. Academic centers were the most frequent protocol initiators in trials where BT was the primary investigational treatment modality (p < 0.01). High dose rate (HDR) BT was the most frequently investigated type of BT dose rate (46.3 %) followed by low dose rate (LDR) (42.0 %). Prostate was the most frequently investigated tumor entity in trials with BT as the primary treatment modality (40.1 %) followed by breast cancer (17.0 %). BT was rarely the primary investigated treatment modality for cervical cancer (6.8 %). Most clinical trials using BT are predominantly in early phases, investigator-initiated and with low accrual numbers. Current investigational activities that include BT mainly focus on prostate and breast cancers. Important questions concerning the optimal usage of BT will not be answered in the near future.

Improving the readability and processability of a pediatric informed consent document: effects on parents' understanding.

PubMed

Tait, Alan R; Voepel-Lewis, Terri; Malviya, Shobha; Philipson, Sandra J

2005-04-01

To examine whether a consent document modified to conform with the federal guidelines for readability and processability would result in greater parental understanding compared with a standard form. Randomized clinical study. The preoperative waiting area of a larger tertiary care children's hospital. A total of 305 parents of children scheduled for minor elective surgical procedures. Parents were randomized to receive information about a clinical study in 1 of 4 ways: (1) standard consent form alone, (2) standard consent form with verbal disclosure, (3) modified form alone (standard form modified to meet the federal guidelines for readability and processability), and (4) modified form with verbal disclosure. Parents were interviewed to determine their understanding of 11 elements of consent, including study purpose, protocol, risks, benefits to child (direct), benefit to others (indirect), freedom to withdraw, alternatives, duration of study, voluntariness, confidentiality, and whom to contact. Their responses were scored by 2 independent assessors. Understanding of the protocol, study duration, risks, and direct benefits, together with overall understanding, was greater among parents who received the modified form (P<.001). Additionally, parents reported that the modified form had greater clarity (P = .009) and improved layout compared with the standard form (P<.001). When parents were shown both forms, 81.2% preferred the modified version. Results suggest that a consent form written according to federal guidelines for readability and processability can improve parent understanding and thus will be important in enhancing the informed consent process.

[Interface interconnection and data integration in implementing of digital operating room].

PubMed

Feng, Jingyi; Chen, Hua; Liu, Jiquan

2011-10-01

The digital operating-room, with highly integrated clinical information, is very important for rescuing lives of patients and improving quality of operations. Since equipments in domestic operating-rooms have diversified interface and nonstandard communication protocols, designing and implementing an integrated data sharing program for different kinds of diagnosing, monitoring, and treatment equipments become a key point in construction of digital operating room. This paper addresses interface interconnection and data integration for commonly used clinical equipments from aspects of hardware interface, interface connection and communication protocol, and offers a solution for interconnection and integration of clinical equipments in heterogeneous environment. Based on the solution, a case of an optimal digital operating-room is presented in this paper. Comparing with the international solution for digital operating-room, the solution proposed in this paper is more economical and effective. And finally, this paper provides a proposal for the platform construction of digital perating-room as well as a viewpoint for standardization of domestic clinical equipments.

Testing for EMC (electromagnetic compatibility) in the clinical environment.

PubMed

Paperman, D; David, Y; Martinez, M

1996-01-01

Testing for electromagnetic compatibility (EMC) in the clinical environment introduces a host of complex conditions not normally encountered under laboratory conditions. In the clinical environment, various radio-frequency (RF) sources of electromagnetic interference (EMI) may be present throughout the entire spectrum of interest. Isolating and analyzing the impact from the sources of interference to medical devices involves a multidisciplinary approach based on training in, and knowledge of, the following: operation of medical devices and their susceptibility to EMI; RF propagation modalities and interaction theory; spectrum analysis systems and techniques (preferably with signature analysis capabilities) and calibrated antennas; the investigation methodology of suspected EMC problems, and testing protocols and standards. Using combinations of standard test procedures adapted for the clinical environment with personnel that have an understanding of radio-frequency behavior increases the probability of controlling, proactively, EMI in the clinical environment, thus providing for a safe and more effective patient care environment.

Toward Reliable Lipoprotein Particle Predictions from NMR Spectra of Human Blood: An Interlaboratory Ring Test.

PubMed

Monsonis Centelles, Sandra; Hoefsloot, Huub C J; Khakimov, Bekzod; Ebrahimi, Parvaneh; Lind, Mads V; Kristensen, Mette; de Roo, Niels; Jacobs, Doris M; van Duynhoven, John; Cannet, Claire; Fang, Fang; Humpfer, Eberhard; Schäfer, Hartmut; Spraul, Manfred; Engelsen, Søren B; Smilde, Age K

2017-08-01

Lipoprotein profiling of human blood by 1 H nuclear magnetic resonance (NMR) spectroscopy is a rapid and promising approach to monitor health and disease states in medicine and nutrition. However, lack of standardization of measurement protocols has prevented the use of NMR-based lipoprotein profiling in metastudies. In this study, a standardized NMR measurement protocol was applied in a ring test performed across three different laboratories in Europe on plasma and serum samples from 28 individuals. Data was evaluated in terms of (i) spectral differences, (ii) differences in LPD predictions obtained using an existing prediction model, and (iii) agreement of predictions with cholesterol concentrations in high- and low-density lipoproteins (HDL and LDL) particles measured by standardized clinical assays. ANOVA-simultaneous component analysis (ASCA) of the ring test spectral ensemble that contains methylene and methyl peaks (1.4-0.6 ppm) showed that 97.99% of the variance in the data is related to subject, 1.62% to sample type (serum or plasma), and 0.39% to laboratory. This interlaboratory variation is in fact smaller than the maximum acceptable intralaboratory variation on quality control samples. It is also shown that the reproducibility between laboratories is good enough for the LPD predictions to be exchangeable when the standardized NMR measurement protocol is followed. With the successful implementation of this protocol, which results in reproducible prediction of lipoprotein distributions across laboratories, a step is taken toward bringing NMR more into scope of prognostic and diagnostic biomarkers, reducing the need for less efficient methods such as ultracentrifugation or high-performance liquid chromatography (HPLC).

Comparison of two automatic methods for the assessment of brachial artery flow-mediated dilation.

PubMed

Faita, Francesco; Masi, Stefano; Loukogeorgakis, Stavros; Gemignani, Vincenzo; Okorie, Mike; Bianchini, Elisabetta; Charakida, Marietta; Demi, Marcello; Ghiadoni, Lorenzo; Deanfield, John Eric

2011-01-01

Brachial artery flow-mediated dilation (FMD) is associated with risk factors providing information on cardiovascular prognosis. Despite the large effort to standardize the methodology, the FMD examination is still characterized by problems of reproducibility and reliability that can be partially overcome with the use of automatic systems. We developed real-time software for the assessment of brachial FMD (FMD Studio, Institute of Clinical Physiology, Pisa, Italy) from ultrasound images. The aim of this study is to compare our system with another automatic method (Brachial Analyzer, MIA LLC, IA, USA) which is currently considered as a reference method in FMD assessment. The agreement between systems was assessed as follows. Protocol 1: Mean baseline (Basal), maximal (Max) brachial artery diameter after forearm ischemia and FMD, calculated as maximal percentage diameter increase, have been evaluated in 60 recorded FMD sequences. Protocol 2: Values of diameter and FMD have been evaluated in 618 frames extracted from 12 sequences. All biases are negligible and standard deviations of the differences are satisfactory (protocol 1: -0.27 ± 0.59%; protocol 2: -0.26 ± 0.61%) for FMD measurements. Analysis times were reduced (-33%) when FMD Studio is used. Rejected examinations due to the poor quality were 2% with the FMD Studio and 5% with the Brachial Analyzer. In conclusion, the compared systems show a optimal grade of agreement and they can be used interchangeably. Thus, the use of a system characterized by real-time functionalities could represent a referral method for assessing endothelial function in clinical trials.

Translating evidence-based protocol of wound drain management for total joint arthroplasty into practice: A quasi-experimental study.

PubMed

Tsang, Lap Fung; Cheng, Hang Cheong; Ho, Hon Shuen; Hsu, Yung Chak; Chow, Chiu Man; Law, Heung Wah; Fong, Lup Chau; Leung, Lok Ming; Kong, Ivy Ching Yan; Chan, Chi Wai; Sham, Alice So Yuen

2016-05-01

Although various drains have long been used in total joint replacement, evidence suggests inconsistent practice exists in the use of drainage systems including intermittently applying suction or free of drainage suction, and variations in the optimal timing for wound drain removal. A comprehensive systematic review of available evidence up to 2013 was conducted in a previous study and a protocol was adapted for clinical application according to the summary of the retrieved information (Tsang, 2015). To determine if the protocol could reduce blood loss and blood transfusion after operation and to develop a record form so as to enhance communication of drainage record amongst surgeons and nurses. A quasi-experimental time-series design was undertaken. In the conventional group, surgeons ordered free drainage if the drain output was more than 300 ml. The time of removal of the drain was based on their professional judgement. In the protocol group the method of drainage was dependant of the drainage output as was the timing of the removal of the drain. A standardized record form was developed to guide operating room and orthopaedic ward nurses to manage the drainage system. The drain was removed significantly earlier in the protocol group. Blood loss rate at the first hour of post-operation was extremely low in the protocol group due to clamping effect. Blood loss in volume during the first three hours in the protocol group was significantly lower than that in the conventional group. Only in 11.1% and 4% of cases was it necessary to clamp at the three and four hour post-operative hours. No clamping was required at the two and eight hour postoperative period. There was no significant difference in blood loss during the removal of the drain and during blood transfusion, which was required for patients upon removal of the drain in the two groups. This is the first clinical study to develop an evidence-based protocol to manage wound drain effectively in Hong Kong. Total blood loss and blood transfusions were not significantly different between the conventional and protocol groups. A standard documentation document is beneficial to enhance communication between doctors and nurses as well as to monitor and observe drainage effectively. Copyright © 2016 Elsevier Ltd. All rights reserved.

A novel protocol for dispatcher assisted CPR improves CPR quality and motivation among rescuers-A randomized controlled simulation study.

PubMed

Rasmussen, Stinne Eika; Nebsbjerg, Mette Amalie; Krogh, Lise Qvirin; Bjørnshave, Katrine; Krogh, Kristian; Povlsen, Jonas Agerlund; Riddervold, Ingunn Skogstad; Grøfte, Thorbjørn; Kirkegaard, Hans; Løfgren, Bo

2017-01-01

Emergency dispatchers use protocols to instruct bystanders in cardiopulmonary resuscitation (CPR). Studies changing one element in the dispatcher's protocol report improved CPR quality. Whether several changes interact is unknown and the effect of combining multiple changes previously reported to improve CPR quality into one protocol remains to be investigated. We hypothesize that a novel dispatch protocol, combining multiple beneficial elements improves CPR quality compared with a standard protocol. A novel dispatch protocol was designed including wording on chest compressions, using a metronome, regular encouragements and a 10-s rest each minute. In a simulated cardiac arrest scenario, laypersons were randomized to perform single-rescuer CPR guided with the novel or the standard protocol. a composite endpoint of time to first compression, hand position, compression depth and rate and hands-off time (maximum score: 22 points). Afterwards participants answered a questionnaire evaluating the dispatcher assistance. The novel protocol (n=61) improved CPR quality score compared with the standard protocol (n=64) (mean (SD): 18.6 (1.4)) points vs. 17.5 (1.7) points, p<0.001. The novel protocol resulted in deeper chest compressions (mean (SD): 58 (12)mm vs. 52 (13)mm, p=0.02) and improved rate of correct hand position (61% vs. 36%, p=0.01) compared with the standard protocol. In both protocols hands-off time was short. The novel protocol improved motivation among rescuers compared with the standard protocol (p=0.002). Participants guided with a standard dispatch protocol performed high quality CPR. A novel bundle of care protocol improved CPR quality score and motivation among rescuers. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Rod Electroretinograms Elicited by Silent Substitution Stimuli from the Light-Adapted Human Eye

PubMed Central

Maguire, John; Parry, Neil R. A.; Kremers, Jan; Kommanapalli, Deepika; Murray, Ian J.; McKeefry, Declan J.

2016-01-01

Purpose To demonstrate that silent substitution stimuli can be used to generate electroretinograms (ERGs) that effectively isolate rod photoreceptor function in humans without the need for dark adaptation, and that this approach constitutes a viable alternative to current clinical standard testing protocols. Methods Rod-isolating and non-isolating sinusoidal flicker stimuli were generated on a 4 primary light-emitting diode (LED) Ganzfeld stimulator to elicit ERGs from participants with normal and compromised rod function who had not undergone dark-adaptation. Responses were subjected to Fourier analysis, and the amplitude and phase of the fundamental were used to examine temporal frequency and retinal illuminance response characteristics. Results Electroretinograms elicited by rod-isolating silent substitution stimuli exhibit low-pass temporal frequency response characteristics with an upper response limit of 30 Hz. Responses are optimal between 5 and 8 Hz and between 10 and 100 photopic trolands (Td). There is a significant correlation between the response amplitudes obtained with the silent substitution method and current standard clinical protocols. Analysis of signal-to-noise ratios reveals significant differences between subjects with normal and compromised rod function. Conclusions Silent substitution provides an effective method for the isolation of human rod photoreceptor function in subjects with normal as well as compromised rod function when stimuli are used within appropriate parameter ranges. Translational Relevance This method of generating rod-mediated ERGs can be achieved without time-consuming periods of dark adaptation, provides improved isolation of rod- from cone-based activity, and will lead to the development of faster clinical electrophysiologic testing protocols with improved selectivity. PMID:27617180

Secure remote access to a clinical data repository using a wireless personal digital assistant (PDA).

PubMed

Duncan, R G; Shabot, M M

2000-01-01

TCP/IP and World-Wide-Web (WWW) technology have become the universal standards for networking and delivery of information. Personal digital assistants (PDAs), cellular telephones, and alphanumeric pagers are rapidly converging on a single pocket device that will leverage wireless TCP/IP networks and WWW protocols and can be used to deliver clinical information and alerts anytime, anywhere. We describe a wireless interface to clinical information for physicians based on Palm Corp.'s Palm VII pocket computer, a wireless digital network, encrypted data transmission, secure web servers, and a clinical data repository (CDR).

Secure remote access to a clinical data repository using a wireless personal digital assistant (PDA).

PubMed Central

Duncan, R. G.; Shabot, M. M.

2000-01-01

TCP/IP and World-Wide-Web (WWW) technology have become the universal standards for networking and delivery of information. Personal digital assistants (PDAs), cellular telephones, and alphanumeric pagers are rapidly converging on a single pocket device that will leverage wireless TCP/IP networks and WWW protocols and can be used to deliver clinical information and alerts anytime, anywhere. We describe a wireless interface to clinical information for physicians based on Palm Corp.'s Palm VII pocket computer, a wireless digital network, encrypted data transmission, secure web servers, and a clinical data repository (CDR). PMID:11079875

Standardizing Naming Conventions in Radiation Oncology

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

Santanam, Lakshmi; Hurkmans, Coen; Mutic, Sasa

2012-07-15

Purpose: The aim of this study was to report on the development of a standardized target and organ-at-risk naming convention for use in radiation therapy and to present the nomenclature for structure naming for interinstitutional data sharing, clinical trial repositories, integrated multi-institutional collaborative databases, and quality control centers. This taxonomy should also enable improved plan benchmarking between clinical institutions and vendors and facilitation of automated treatment plan quality control. Materials and Methods: The Advanced Technology Consortium, Washington University in St. Louis, Radiation Therapy Oncology Group, Dutch Radiation Oncology Society, and the Clinical Trials RT QA Harmonization Group collaborated in creatingmore » this new naming convention. The International Commission on Radiation Units and Measurements guidelines have been used to create standardized nomenclature for target volumes (clinical target volume, internal target volume, planning target volume, etc.), organs at risk, and planning organ-at-risk volumes in radiation therapy. The nomenclature also includes rules for specifying laterality and margins for various structures. The naming rules distinguish tumor and nodal planning target volumes, with correspondence to their respective tumor/nodal clinical target volumes. It also provides rules for basic structure naming, as well as an option for more detailed names. Names of nonstandard structures used mainly for plan optimization or evaluation (rings, islands of dose avoidance, islands where additional dose is needed [dose painting]) are identified separately. Results: In addition to its use in 16 ongoing Radiation Therapy Oncology Group advanced technology clinical trial protocols and several new European Organization for Research and Treatment of Cancer protocols, a pilot version of this naming convention has been evaluated using patient data sets with varying treatment sites. All structures in these data sets were satisfactorily identified using this nomenclature. Conclusions: Use of standardized naming conventions is important to facilitate comparison of dosimetry across patient datasets. The guidelines presented here will facilitate international acceptance across a wide range of efforts, including groups organizing clinical trials, Radiation Oncology Institute, Dutch Radiation Oncology Society, Integrating the Healthcare Enterprise, Radiation Oncology domain (IHE-RO), and Digital Imaging and Communication in Medicine (DICOM).« less

Three-Dimensional Upper Limb Movement Characteristics in Children with Hemiplegic Cerebral Palsy and Typically Developing Children

ERIC Educational Resources Information Center

Jaspers, Ellen; Desloovere, Kaat; Bruyninckx, Herman; Klingels, Katrijn; Molenaers, Guy; Aertbelien, Erwin; Van Gestel, Leen; Feys, Hilde

2011-01-01

The aim of this study was to measure which three-dimensional spatiotemporal and kinematic parameters differentiate upper limb movement characteristics in children with hemiplegic cerebral palsy (HCP) from those in typically developing children (TDC), during various clinically relevant tasks. We used a standardized protocol containing three reach…

Practice guidelines for music interventions with hospitalized pediatric patients.

PubMed

Stouffer, Janice W; Shirk, Beverly J; Polomano, Rosemary C

2007-12-01

Music therapy is an effective complementary approach that can achieve specific therapeutic outcomes in the clinical management of pediatric patients. Growing research on music interventions has generated scientific knowledge about how this modality benefits patients and has formed the basis for effective protocols that can be used in practice. Although it can be challenging to translate research-based protocols into routine clinical care at the bedside, it is essential that music therapy interventions be aligned with evidence-based information and that accepted standards be established by the music therapy discipline to achieve the greatest benefit. The importance of partnerships between nurses and music therapists is emphasized to enhance the success of music-based treatments. This discussion synthesizes research findings that can be used to design pediatric practice guidelines in the application of music therapy.

Intense pulse light and 5-ALA PDT: phototoxic effects in vitro depend on the spectral overlap with protoporphyrine IX but do not match cut-off filter notations.

PubMed

Maisch, Tim; Moor, Anne C E; Regensburger, Johannes; Ortland, Christoph; Szeimies, Rolf-Markus; Bäumler, Wolfgang

2011-02-01

Successful photodynamic therapy (PDT) requires a light source by which light is absorbed by the photosensitizer. Such absorption is achieved by adapting the emission spectrum of the lamp to the absorption-spectrum of the photosensitizer. Intense pulsed light sources (IPLs) are widely used in dermatology, but a standardized protocol for IPL-PDT is not available. Five different IPLs were chosen to evaluate their efficacy for PDT in vitro and the possibility for developing a standard protocol for PDT. Emission-spectra of IPLs were measured with an optical spectrograph and compared with the absorption spectrum of protoporphyrine IX (PpIX). Keratinocytes were incubated with 5-ALA and illuminated with the IPLs. Cell viability was determined for radiant exposures ranging from 0 to 504 J/cm(2) and pulse durations from 8 to 100 milliseconds. A standard LED light source was used as a reference. Cell viability is less effectively reduced by 5-ALA-PDT with IPLs than by a LED light source. Radiant exposures of the five IPLs ranged between 80 and 311 J/cm(2) to achieve the EC(50) value. This value correlated with the spectral overlap of the respective IPL and the absorption-spectrum of PpIX but not with the cut-off filter notations supplied by the manufacturer. All IPLs assessed emit different spectra because of different filter technologies. Different radiant exposures (J/cm(2) ) were necessary to achieve a photodynamic effect with 5-ALA in vitro depending on these spectra similar to the photodynamic effect of the standard LED light source. IPLs may be applicable in clinical PDT but radiant exposure protocols must be separately evaluated for each single IPL despite similar cut-off filter specifications. Such protocols are highly important for clinical practice to avoid a potential mismatch of excitation wavelengths and to prevent photothermal side effects when light intensities of up to hundreds of W/cm(2) are applied. Copyright © 2011 Wiley-Liss, Inc.

Impact on delay times and characteristics of patients undergoing primary percutaneous coronary intervention in the southern metropolitan area of Barcelona after implementation of the infarction code program.

PubMed

Gómez-Hospital, Joan Antoni; Dallaglio, Paolo Domenico; Sánchez-Salado, Jose Carlos; Ariza, Albert; Homs, Silvia; Lorente, Victoria; Ferreiro, Jose Luis; Gomez-Lara, Josep; Romaguera, Rafael; Salazar-Mendiguchía, Joel; Teruel, Luis; Cequier, Ángel

2012-10-01

A standardized protocol of emergent transfer for primary percutaneous coronary intervention for patients with ST elevation myocardial infarction, defined as the Infarction Code, was implemented in June 2009 in the Catalan regional health system. The objective of this study was to evaluate the impact of the new protocol on delay times, number of procedures and clinical characteristics compared with the previous period in the population of patients referred to our hospital. All consecutive patients undergoing primary percutaneous coronary intervention in our hospital were prospectively registered. The clinical characteristics, delay times and mortality in the follow-up of the protocol implementation period (June 2009-May 2010) were analyzed and compared with the previous year (June 2008-May 2009). During the protocol period, 514 patients were included, compared with 241 in the previous year. Age, cardiovascular risk factors, anterior myocardial infarction and procedure characteristics were similar in the 2 groups. The first medical contact to balloon time was lower in the protocol period (median time 120 min vs 88 min; P<.001). Patients in the protocol period showed a trend toward less severe disease (Killip III, rescue angioplasty). The multivariate regression analysis showed a significant association between 1-year mortality and age, Killip class ≥ III at admission, anterior infarction and 3-vessel disease. The introduction of the Infarction Code program increased the number of patients treated by primary percutaneous coronary intervention with a reduction in delay times and better clinical characteristics at presentation. Full English text available from:www.revespcardiol.org. Copyright © 2012 Sociedad Española de Cardiología. Published by Elsevier Espana. All rights reserved.

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.

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study.

PubMed

Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

2017-01-01

Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes performed better than controls, with similar effect size (ES). The efficacy of abbreviated mindfulness programmes may be similar to that of a standard MBI programme, making them potentially more accessible for a larger number of populations. Nevertheless, further studies with more powerful designs to compare the non-inferiority of the abbreviated protocol and addressing clinical populations are warranted. Clinical Trials.gov Registration ID: NCT02643927.

Efficacy of 8- and 4-Session Mindfulness-Based Interventions in a Non-clinical Population: A Controlled Study

PubMed Central

Demarzo, Marcelo; Montero-Marin, Jesus; Puebla-Guedea, Marta; Navarro-Gil, Mayte; Herrera-Mercadal, Paola; Moreno-González, Sergio; Calvo-Carrión, Sandra; Bafaluy-Franch, Laura; Garcia-Campayo, Javier

2017-01-01

Background: Many attempts have been made to abbreviate mindfulness programmes in order to make them more accessible for general and clinical populations while maintaining their therapeutic components and efficacy. The aim of this study was to assess the efficacy of an 8-week mindfulness-based intervention (MBI) programme and a 4-week abbreviated version for the improvement of well-being in a non-clinical population. Method: A quasi-experimental, controlled, pilot study was conducted with pre-post and 6-month follow-up measurements and three study conditions (8- and 4-session MBI programmes and a matched no-treatment control group, with a sample of 48, 46, and 47 participants in each condition, respectively). Undergraduate students were recruited, and mindfulness, positive and negative affect, self-compassion, resilience, anxiety, and depression were assessed. Mixed-effects multi-level analyses for repeated measures were performed. Results: The intervention groups showed significant improvements compared to controls in mindfulness and positive affect at the 2- and 6-month follow-ups, with no differences between 8- vs. 4-session programmes. The only difference between the abbreviated MBI vs. the standard MBI was found in self-kindness at 6 months, favoring the standard MBI. There were marginal differences in anxiety between the controls vs. the abbreviated MBI, but there were differences between the controls vs. the standard MBI at 2- and 6-months, with higher levels in the controls. There were no differences in depression between the controls vs. the abbreviated MBI, but differences were found between the controls vs. the standard MBI at 2- and 6-months, favoring the standard MBI. There were no differences with regard to negative affect and resilience. Conclusion: To our knowledge, this is the first study to directly investigate the efficacy of a standard 8-week MBI and a 4-week abbreviated protocol in the same population. Based on our findings, both programmes performed better than controls, with similar effect size (ES). The efficacy of abbreviated mindfulness programmes may be similar to that of a standard MBI programme, making them potentially more accessible for a larger number of populations. Nevertheless, further studies with more powerful designs to compare the non-inferiority of the abbreviated protocol and addressing clinical populations are warranted. Clinical Trials.gov Registration ID: NCT02643927 PMID:28848465

SU-E-J-19: An Intra-Institutional Study of Cone-Beam CT Dose for Image-Guided Radiation Therapy

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

Knutson, N; Present Address: Mount Sinai Roosevelt Hospital, New York, NY; Rankine, L

2015-06-15

Purpose: To determine the variability of Cone-Beam CT Dose Index (CB-CTDI) across multiple on-board imaging (OBI) systems within a single institution, and compare this to manufacturer provided data. Methods: The CB-CTDI was measured on three Trilogy and three TrueBeam Varian OBI systems, for six different clinically used scan protocols. Measurements were taken using a 10 cm long CT ionization chamber in either a 16 cm (head-simulating) or 32 cm (body-simulating) diameter, acrylic, cylindrical, 15 cm long CTDI phantom. We assessed the variation in CB-CTDI between the OBI systems and compared our measured values to the data provided by the manufacturer.more » Results: The standard error in the CB-CTDI measured for all protocols was found to be within ±2% and ±5% of the mean for TrueBeam and Trilogy, respectively. For all head scan protocols, the measured TrueBeam values were lower than the manufacturer’s reported values, with a maximum difference of 13.9% and an average difference of 11%. For the body scan protocols, the TrueBeam measured values were 3% and 13% greater than the manufacturer’s reported values for two out of three protocols, and 38% lower than reported for the third protocol. In total, 7/18 CB-CTDI measurements fell within the manufacturers specified range (±10%). Across all scans the Truebeam machines were found to have a lower CB-CTDI than Trilogy, particularly the head scan protocols, which show decreases of up to 30% . Conclusion: The intra-institutional variation of CB-CTDI was found to be clinically acceptable at less than 5%. For the TrueBeam OBI system, over half of the measured scans failed to fall with in the manufactured quoted range of 10%, however, all measured values were within 15% of the manufacturer’s reported values. For accurate assessment and reporting of imaging dose to radiotherapy patients, our results indicate a need for standardization in CB-CTDI measurement technique.« less

SU-F-J-16: Planar KV Imaging Dose Reduction Study

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

Gershkevitsh, E; Zolotuhhin, D

Purpose: IGRT has become an indispensable tool in modern radiotherapy with kV imaging used in many departments due to superior image quality and lower dose when compared to MV imaging. Many departments use manufacturer supplied protocols for imaging which are not always optimised between image quality and radiation dose (ALARA). Methods: Whole body phantom PBU-50 (Kyoto Kagaku ltd., Japan) for imaging in radiology has been imaged on Varian iX accelerator (Varian Medical Systems, USA) with OBI 1.5 system. Manufacturer’s default protocols were adapted by modifying kV and mAs values when imaging different anatomical regions of the phantom (head, thorax, abdomen,more » pelvis, extremities). Images with different settings were independently reviewed by two persons and their suitability for IGRT set-up correction protocols were evaluated. The suitable images with the lowest mAs were then selected. The entrance surface dose (ESD) for manufacturer’s default protocols and modified protocols were measured with RTI Black Piranha (RTI Group, Sweden) and compared. Image quality was also measured with kVQC phantom (Standard Imaging, USA) for different protocols. The modified protocols have been applied for clinical work. Results: For most cases optimized protocols reduced the ESD on average by a factor of 3(range 0.9–8.5). Further reduction in ESD has been observed by applying bow-tie filter designed for CBCT. The largest reduction in dose (12.2 times) was observed for Thorax lateral protocol. The dose was slightly increased (by 10%) for large pelvis AP protocol. Conclusion: Manufacturer’s default IGRT protocols could be optimised to reduce the ESD to the patient without losing the necessary image quality for patient set-up correction. For patient set-up with planar kV imaging the bony anatomy is mostly used and optimization should focus on this aspect. Therefore, the current approach with anthropomorphic phantom is more advantageous in optimization over standard kV quality control phantoms and SNR metrics.« less

Improving metabolic monitoring in patients maintained on antipsychotics in Penang, Malaysia.

PubMed

Hor, Esther Sl; Subramaniam, Sivasangari; Koay, Jun Min; Bharathy, Arokiamary; Vasudevan, Umadevi; Panickulam, Joseph J; Ng, InnTiong; Arif, Nor Hayati; Russell, Vincent

2016-02-01

To evaluate the monitoring of metabolic parameters among outpatients maintained on antipsychotic medications in a general hospital setting in Malaysia and to assess the impact of a local monitoring protocol. By performing a baseline audit of files from a random sample of 300 patients prescribed antipsychotic medications for at least 1 year; we determined the frequency of metabolic monitoring. The findings informed the design of a new local protocol, on which clinical staff was briefed. We re-evaluated metabolic monitoring immediately after implementation, in a small sample of new referrals and current patients. We explored staff perceptions of the initiative with a follow-up focus group, 6 months post-implementation. The baseline audit revealed a sub-optimal frequency of metabolic parameter recording. Re-audit, following implementation of the new protocol, revealed improved monitoring but persisting deficits. Dialogue with the clinical staff led to further protocol modification, clearer definition of staff roles and use of a standard recording template. Focus group findings revealed positive perceptions of the initiative, but persisting implementation barriers, including cultural issues surrounding waist circumference measurement. Responding to challenges in achieving improved routine metabolic monitoring of patients maintained on antipsychotics required on-going dialogue with the clinical staff, in order to address both service pressures and cultural concerns. © The Royal Australian and New Zealand College of Psychiatrists 2015.

Neurologic 3D MR Spectroscopic Imaging with Low-Power Adiabatic Pulses and Fast Spiral Acquisition

PubMed Central

Gagoski, Borjan A.; Sorensen, A. Gregory

2012-01-01

Purpose: To improve clinical three-dimensional (3D) MR spectroscopic imaging with more accurate localization and faster acquisition schemes. Materials and Methods: Institutional review board approval and patient informed consent were obtained. Data were acquired with a 3-T MR imager and a 32-channel head coil in phantoms, five healthy volunteers, and five patients with glioblastoma. Excitation was performed with localized adiabatic spin-echo refocusing (LASER) by using adiabatic gradient-offset independent adiabaticity wideband uniform rate and smooth truncation (GOIA-W[16,4]) pulses with 3.5-msec duration, 20-kHz bandwidth, 0.81-kHz amplitude, and 45-msec echo time. Interleaved constant-density spirals simultaneously encoded one frequency and two spatial dimensions. Conventional phase encoding (PE) (1-cm3 voxels) was performed after LASER excitation and was the reference standard. Spectra acquired with spiral encoding at similar and higher spatial resolution and with shorter imaging time were compared with those acquired with PE. Metabolite levels were fitted with software, and Bland-Altman analysis was performed. Results: Clinical 3D MR spectroscopic images were acquired four times faster with spiral protocols than with the elliptical PE protocol at low spatial resolution (1 cm3). Higher-spatial-resolution images (0.39 cm3) were acquired twice as fast with spiral protocols compared with the low-spatial-resolution elliptical PE protocol. A minimum signal-to-noise ratio (SNR) of 5 was obtained with spiral protocols under these conditions and was considered clinically adequate to reliably distinguish metabolites from noise. The apparent SNR loss was not linear with decreasing voxel sizes because of longer local T2* times. Improvement of spectral line width from 4.8 Hz to 3.5 Hz was observed at high spatial resolution. The Bland-Altman agreement between spiral and PE data is characterized by narrow 95% confidence intervals for their differences (0.12, 0.18 of their means). GOIA-W(16,4) pulses minimize chemical-shift displacement error to 2.1%, reduce nonuniformity of excitation to 5%, and eliminate the need for outer volume suppression. Conclusion: The proposed adiabatic spiral 3D MR spectroscopic imaging sequence can be performed in a standard clinical MR environment. Improvements in image quality and imaging time could enable more routine acquisition of spectroscopic data than is possible with current pulse sequences. © RSNA, 2011 PMID:22187628

Effective Dose of CT- and Fluoroscopy-Guided Perineural/Epidural Injections of the Lumbar Spine: A Comparative Study

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

Schmid, Gebhard; Schmitz, Alexander; Borchardt, Dieter

The objective of this study was to compare the effective radiation dose of perineural and epidural injections of the lumbar spine under computed tomography (CT) or fluoroscopic guidance with respect to dose-reduced protocols. We assessed the radiation dose with an Alderson Rando phantom at the lumbar segment L4/5 using 29 thermoluminescence dosimeters. Based on our clinical experience, 4-10 CT scans and 1-min fluoroscopy are appropriate. Effective doses were calculated for CT for a routine lumbar spine protocol and for maximum dose reduction; as well as for fluoroscopy in a continuous and a pulsed mode (3-15 pulses/s). Effective doses under CTmore » guidance were 1.51 mSv for 4 scans and 3.53 mSv for 10 scans using a standard protocol and 0.22 mSv and 0.43 mSv for the low-dose protocol. In continuous mode, the effective doses ranged from 0.43 to 1.25 mSv for 1-3 min of fluoroscopy. Using 1 min of pulsed fluoroscopy, the effective dose was less than 0.1 mSv for 3 pulses/s. A consequent low-dose CT protocol reduces the effective dose compared to a standard lumbar spine protocol by more than 85%. The latter dose might be expected when applying about 1 min of continuous fluoroscopy for guidance. A pulsed mode further reduces the effective dose of fluoroscopy by 80-90%.« less

Correction of stain variations in nuclear refractive index of clinical histology specimens

PubMed Central

Uttam, Shikhar; Bista, Rajan K.; Hartman, Douglas J.; Brand, Randall E.; Liu, Yang

2011-01-01

For any technique to be adopted into a clinical setting, it is imperative that it seamlessly integrates with well-established clinical diagnostic workflow. We recently developed an optical microscopy technique—spatial-domain low-coherence quantitative phase microscopy (SL-QPM) that can extract the refractive index of the cell nucleus from the standard histology specimens on glass slides prepared via standard clinical protocols. This technique has shown great potential in detecting cancer with a better sensitivity than conventional pathology. A major hurdle in the clinical translation of this technique is the intrinsic variation among staining agents used in histology specimens, which limits the accuracy of refractive index measurements of clinical samples. In this paper, we present a simple and easily generalizable method to remove the effect of variations in staining levels on nuclear refractive index obtained with SL-QPM. We illustrate the efficacy of our correction method by applying it to variously stained histology samples from animal model and clinical specimens. PMID:22112118

Low CREBBP expression is associated with adverse long-term outcomes in paediatric acute lymphoblastic leukaemia.

PubMed

Gao, Chao; Zhang, Rui-Dong; Liu, Shu-Guang; Zhao, Xiao-Xi; Cui, Lei; Yue, Zhi-Xia; Li, Wei-Jing; Chen, Zhen-Ping; Li, Zhi-Gang; Rao, Qing; Wang, Min; Zheng, Hu-Yong; Wang, Jian-Xiang

2017-08-01

CREBBP alterations are associated with many diseases including leukaemia. However, CREBBP expression and its clinical relevance in paediatric acute lymphoblastic leukaemia have not been elucidated. We studied CREBBP mRNA expression in 349 patients treated with either the BCH-2003 or CCLG-2008 protocol. Using a receiver operating characteristic curve, patients were divided into low- or high-CREBBP. The association among clinicobiological characteristics, outcomes and CREBBP level was analysed. Low expression of CREBBP (<1.0) at diagnosis was found in 97.7% of patients and increased significantly after complete remission. Low-CREBBP patients were associated with unfavourable clinical presentations, poor prednisone response and high minimal residual disease (>10 -2 ) after induction. We found significantly poorer event-free survival (EFS) and overall survival (OS) in low-CREBBP group whether administered BCH-2003 or CCLG-2008. Low-CREBBP was an inferior independent prognostic factor in BCH-2003; patients with low-CREBBP had better outcomes on an intermediate-risk regimen than a standard-risk regimen involving the CCLG-2008 protocol. Patients stratified to high-risk with low-CREBBP had the worst EFS and OS. These findings indicate that low-CREBBP is predictive of unfavourable outcomes; thus, a more intensive treatment protocol is necessitated for standard-risk patients with insufficient CREBBP and that a specific target therapy is necessitated for high-risk patients. © 2017 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Protocol Coordinator | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. KEY ROLES/RESPONSIBILITIES The Protocol Coordinator II: Provides comprehensive clinical and administrative support to the Brain Tumor Trial Collaborative, Neuro-Oncology Branch, NCI, National Institutes of Health Serves as a liaison with Principal Investigators (PIs), the associated study teams and a variety of offices associated with protocol development and approvals Orchestrates meetings with investigators and other key medical staff to identify required support Coordinates the writing and regulatory review processes that occur in tandem, facilitates the bi-directional dialogue and feedback between various teams, and assists investigators and medical writers on the production/revision of clinical research protocols Assists research staff in coordinating/navigating requirements for special circumstances and facilitates access to necessary services Facilitates initiation of intramural research by providing assistance in obtaining required approvals Coordinates with investigators and medical writers to ensure Institutional Review Board (IRB) and Food and Drug Administration (FDA) stipulations are appropriately addressed in a timely manner Provides consultation and assistance for all aspects of the protocol lifecycle including initial Investigational New Drug (IND) submission, IRB submission, continuing review applications, protocol amendments, annual reports, and protocol inactivation with IRB and FDA Tracks a portfolio of protocols through each lifecycle step; processes and tracks appropriate approvals (e.g., IRB, Data and Safety Monitoring Board, Radiation Safety, Office of Protocol Services, etc.) Provides administrative support to Scientific Review Committees (SRC), reviews proposed protocol documents to ensure they are complete, distributes to reviewers, documents meeting minutes, enters data into the IRIS database, facilitates processes to obtain approval to initiate and continue clinical research Creates, maintains and queries an IRB database of approved amendment descriptions Maintains records of the current protocol(s) version, current Informed Consent document(s), FDA Safe to Proceed designation, etc. for each IND Provides expertise in data management including data collection and analysis Develops procedural manuals for clinical trials protocols Participates in quality improvement and assurance involving International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines This position is located at the National Institutes of Health (NIH) in Bethesda, Maryland.

Multicenter Cell Processing for Cardiovascular Regenerative Medicine Applications - The Cardiovascular Cell Therapy Research Network (CCTRN) Experience

PubMed Central

Gee, Adrian P.; Richman, Sara; Durett, April; McKenna, David; Traverse, Jay; Henry, Timothy; Fisk, Diann; Pepine, Carl; Bloom, Jeannette; Willerson, James; Prater, Karen; Zhao, David; Koç, Jane Reese; Ellis, Steven; Taylor, Doris; Cogle, Christopher; Moyé, Lemuel; Simari, Robert; Skarlatos, Sonia

2013-01-01

Background Aims Multi-center cellular therapy clinical trials require the establishment and implementation of standardized cell processing protocols and associated quality control mechanisms. The aims here were to develop such an infrastructure in support of the Cardiovascular Cell Therapy Research Network (CCTRN) and to report on the results of processing for the first 60 patients. Methods Standardized cell preparations, consisting of autologous bone marrow mononuclear cells, prepared using the Sepax device were manufactured at each of the five processing facilities that supported the clinical treatment centers. Processing staff underwent centralized training that included proficiency evaluation. Quality was subsequently monitored by a central quality control program that included product evaluation by the CCTRN biorepositories. Results Data from the first 60 procedures demonstrate that uniform products, that met all release criteria, could be manufactured at all five sites within 7 hours of receipt of the bone marrow. Uniformity was facilitated by use of the automated systems (the Sepax for processing and the Endosafe device for endotoxin testing), standardized procedures and centralized quality control. Conclusions Complex multicenter cell therapy and regenerative medicine protocols can, where necessary, successfully utilize local processing facilities once an effective infrastructure is in place to provide training, and quality control. PMID:20524773

Dual-energy CT and ceramic or titanium prostheses material reduce CT artifacts and provide superior image quality of total knee arthroplasty.

PubMed

Kasparek, Maximilian F; Töpker, Michael; Lazar, Mathias; Weber, Michael; Kasparek, Michael; Mang, Thomas; Apfaltrer, Paul; Kubista, Bernd; Windhager, Reinhard; Ringl, Helmut

2018-06-07

To evaluate the influence of different scan parameters for single-energy CT and dual-energy CT, as well as the impact of different material used in a TKA prosthesis on image quality and the extent of metal artifacts. Eight pairs of TKA prostheses from different vendors were examined in a phantom set-up. Each pair consisted of a conventional CoCr prosthesis and the corresponding anti-allergic prosthesis (full titanium, ceramic, or ceramic-coated) from the same vendor. Nine different (seven dual-energy CT and two single-energy CT) scan protocols with different characteristics were used to determine the most suitable CT protocol for TKA imaging. Quantitative image analysis included assessment of blooming artifacts (metal implants appear thicker on CT than they are, given as virtual growth in mm in this paper) and streak artifacts (thick dark lines around metal). Qualitative image analysis was used to investigate the bone-prosthesis interface. The full titanium prosthesis and full ceramic knee showed significantly fewer blooming artifacts compared to the standard CoCr prosthesis (mean virtual growth 0.6-2.2 mm compared to 2.9-4.6 mm, p < 0.001). Dual-energy CT protocols showed less blooming (range 3.3-3.8 mm) compared to single-energy protocols (4.6-5.5 mm). The full titanium and full ceramic prostheses showed significantly fewer streak artifacts (mean standard deviation 77-86 Hounsfield unit (HU)) compared to the standard CoCr prosthesis (277-334 HU, p < 0.001). All dual-energy CT protocols had fewer metal streak artifacts (215-296 HU compared to single-energy CT protocols (392-497 HU)). Full titanium and ceramic prostheses were ranked superior with regard to the image quality at the bone/prosthesis interface compared to a standard CoCr prosthesis, and all dual-energy CT protocols were ranked better than single-energy protocols. Dual-energy CT and ceramic or titanium prostheses reduce CT artifacts and provide superior image quality of total knee arthroplasty at the bone/prosthesis interface. These findings support the use of dual-energy CT as a solid imaging base for clinical decision-making and the use of full-titanium or ceramic prostheses to allow for better CT visualization of the bone-prosthesis interface.

Application of evidence-based dentistry: from research to clinical periodontal practice.

PubMed

Kwok, Vivien; Caton, Jack G; Polson, Alan M; Hunter, Paul G

2012-06-01

Dentists need to make daily decisions regarding patient care, and these decisions should essentially be scientifically sound. Evidence-based dentistry is meant to empower clinicians to provide the most contemporary treatment. The benefits of applying the evidence-based method in clinical practice include application of the most updated treatment and stronger reasoning to justify the treatment. A vast amount of information is readily accessible with today's digital technology, and a standardized search protocol can be developed to ensure that a literature search is valid, specific and repeatable. It involves developing a preset question (population, intervention, comparison and outcome; PICO) and search protocol. It is usually used academically to perform commissioned reviews, but it can also be applied to answer simple clinical queries. The scientific evidence thus obtained can then be considered along with patient preferences and values, clinical patient circumstances and the practitioner's experience and judgment in order to make the treatment decision. This paper describes how clinicians can incorporate evidence-based methods into patient care and presents a clinical example to illustrate the process. © 2012 John Wiley & Sons A/S.

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

PubMed

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

2017-07-01

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

Individual researcher liability for clinical research on humans.

PubMed

Miller, Ruth K

2003-01-01

Despite international guidelines and federal regulations, a recent rash of problems in clinical trials have highlighted weaknesses in the oversight process. The federal regulatory system depends on self-policing by researchers and institutions. Because the existing system is overworked, applying common law forms of liability to clinical researchers may encourage improvements in this self-regulation. While research necessarily involves uncertainties, researchers have the greatest direct control over the implementation of the research protocol and the most extensive direct contact with subjects, and must bear corresponding responsibility for acts which fall below the standard of care. This paper argues that the existing FDA patient protections should be adopted as the standards of care for researchers. It examines the possible application of negligence, negligence per se, and fraud and misrepresentation claims against researchers.

Techniques for physicochemical characterization of nanomaterials

PubMed Central

Lin, Ping-Chang; Lin, Stephen; Wang, Paul C.; Sridhar, Rajagopalan

2014-01-01

Advances in nanotechnology have opened up a new era of diagnosis, prevention and treatment of diseases and traumatic injuries. Nanomaterials, including those with potential for clinical applications, possess novel physicochemical properties that have an impact on their physiological interactions, from the molecular level to the systemic level. There is a lack of standardized methodologies or regulatory protocols for detection or characterization of nanomaterials. This review summarizes the techniques that are commonly used to study the size, shape, surface properties, composition, purity and stability of nanomaterials, along with their advantages and disadvantages. At present there are no FDA guidelines that have been developed specifically for nanomaterial based formulations for diagnostic or therapeutic use. There is an urgent need for standardized protocols and procedures for the characterization of nanoparticles, especially those that are intended for use as theranostics. PMID:24252561

International Standardization of the Clinical Dosimetry of Beta Radiation Brachytherapy Sources: Progress of an ISO Standard

NASA Astrophysics Data System (ADS)

Soares, Christopher

2006-03-01

In 2004 a new work item proposal (NWIP) was accepted by the International Organization for Standardization (ISO) Technical Committee 85 (TC85 -- Nuclear Energy), Subcommittee 2 (Radiation Protection) for the development of a standard for the clinical dosimetry of beta radiation sources used for brachytherapy. To develop this standard, a new Working Group (WG 22 - Ionizing Radiation Dosimetry and Protocols in Medical Applications) was formed. The standard is based on the work of an ad-hoc working group initiated by the Dosimetry task group of the Deutsches Insitiut für Normung (DIN). Initially the work was geared mainly towards the needs of intravascular brachytherapy, but with the decline of this application, more focus has been placed on the challenges of accurate dosimetry for the concave eye plaques used to treat ocular melanoma. Guidance is given for dosimetry formalisms, reference data to be used, calibrations, measurement methods, modeling, uncertainty determinations, treatment planning and reporting, and clinical quality control. The document is currently undergoing review by the ISO member bodies for acceptance as a Committee Draft (CD) with publication of the final standard expected by 2007. There are opportunities for other ISO standards for medical dosimetry within the framework of WG22.

[Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer].

PubMed

2018-04-01

Colorectal cancer is one of the most common malignant tumors in China. In 2012 one million thirty six thousand cases of colorectal cancer were diagnosed all over the world, two hundred fifty three thousand cases were diagnosed in China (accounted for 18.6%). China has the largest number of new cases of colorectal cancer in the world. Colorectal cancer has becoming a serious threat of Chinese residents' health. In 2010, the National Ministry of Health organized colorectal cancer expertise of the Chinese Medical Association to write the "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2010edition), and publish it publicly. In recent years, the National Health and Family Planning Commission has organized experts to revised the protocol 2 times: the first time in 2015, the second time in 2017. The revised part of "Chinese Protocol of Diagnosis and Treatment of Colorectal Cancer" (2017 edition) involves new progress in the field of imaging examination, pathological evaluation, surgery, chemotherpy and radiotherapy. The 2017 edition of the protocol not only referred to the contents of the international guidelines, but also combined with the specific national conditions and clinical practice in China, and also included many evidence-based clinical data in China recently. The 2017 edition of the protocol would further promote the standardization of diagnosis and treatment of colorectal cancer in China, improve the survival and prognosis of patients, and benefit millions of patients with colorectal cancer and their families.

Impact of a pain protocol including hypnosis in major burns.

PubMed

Berger, Mette M; Davadant, Maryse; Marin, Christian; Wasserfallen, Jean-Blaise; Pinget, Christophe; Maravic, Philippe; Koch, Nathalie; Raffoul, Wassim; Chiolero, René L

2010-08-01

Pain is a major issue after burns even when large doses of opioids are prescribed. The study focused on the impact of a pain protocol using hypnosis on pain intensity, anxiety, clinical course, and costs. All patients admitted to the ICU, aged >18 years, with an ICU stay >24h, accepting to try hypnosis, and treated according to standardized pain protocol were included. Pain was scaled on the Visual Analog Scale (VAS) (mean of daily multiple recordings), and basal and procedural opioid doses were recorded. Clinical outcome and economical data were retrieved from hospital charts and information system, respectively. Treated patients were matched with controls for sex, age, and the burned surface area. Forty patients were admitted from 2006 to 2007: 17 met exclusion criteria, leaving 23 patients, who were matched with 23 historical controls. Altogether patients were 36+/-14 years old and burned 27+/-15%BSA. The first hypnosis session was performed after a median of 9 days. The protocol resulted in the early delivery of higher opioid doses/24h (p<0.0001) followed by a later reduction with lower pain scores (p<0.0001), less procedural related anxiety, less procedures under anaesthesia, reduced total grafting requirements (p=0.014), and lower hospital costs per patient. A pain protocol including hypnosis reduced pain intensity, improved opioid efficiency, reduced anxiety, improved wound outcome while reducing costs. The protocol guided use of opioids improved patient care without side effects, while hypnosis had significant psychological benefits.

Implementation of a 5-Minute Magnetic Resonance Imaging Screening Protocol for Prostate Cancer in Men With Elevated Prostate-Specific Antigen Before Biopsy.

PubMed

Weiss, Jakob; Martirosian, Petros; Notohamiprodjo, Mike; Kaufmann, Sascha; Othman, Ahmed E; Grosse, Ulrich; Nikolaou, Konstantin; Gatidis, Sergios

2018-03-01

The aims of this study were to establish a 5-minute magnetic resonance (MR) screening protocol for prostate cancer in men before biopsy and to evaluate effects on Prostate Imaging Reporting and Data System (PI-RADS) V2 scoring in comparison to a conventional, fully diagnostic multiparametric MR imaging (mpMRI) approach. Fifty-two patients with elevated prostate-specific antigen levels and without prior biopsy were prospectively included in this institutional review board-approved study. In all patients, an mpMRI protocol according to the PI-RADS recommendations was acquired on a 3 T MRI system. In addition, an accelerated diffusion-weighted imaging sequence was acquired using simultaneous multislice technique (DW-EPISMS). Two readers independently evaluated the images for the presence/absence of prostate cancer according to the PI-RADS criteria and for additional findings. In a first reading session, only the screening protocol consisting of axial T2-weighted and DW-EPISMS images was made available. In a subsequent reading session, the mpMRI protocol was assessed blinded to the results of the first reading, serving as reference standard. Both readers successfully established a final diagnosis according to the PI-RADS criteria in the screening and mpMRI protocol. Mean lesion size was 1.2 cm in the screening and 1.4 cm in the mpMRI protocol (P = 0.4) with 35% (18/52) of PI-RADS IV/V lesions. Diagnostic performance of the screening protocol was excellent with a sensitivity and specificity of 100% for both readers with no significant differences in comparison to the mpMRI standard (P = 1.0). In 3 patients, suspicious lymph nodes were reported as additional finding, which were equally detectable in the screening and mpMRI protocol. A 5-minute MR screening protocol for prostate cancer in men with elevated prostate-specific antigen levels before biopsy is applicable for clinical routine with similar diagnostic performance as the full diagnostic mpMRI approach.

Dependency of image quality on acquisition protocol and image processing in chest tomosynthesis-a visual grading study based on clinical data.

PubMed

Jadidi, Masoud; Båth, Magnus; Nyrén, Sven

2018-04-09

To compare the quality of images obtained with two different protocols with different acquisition time and the influence from image post processing in a chest digital tomosynthesis (DTS) system. 20 patients with suspected lung cancer were imaged with a chest X-ray equipment with tomosynthesis option. Two examination protocols with different acquisition times (6.3 and 12 s) were performed on each patient. Both protocols were presented with two different image post-processing (standard DTS processing and more advanced processing optimised for chest radiography). Thus, 4 series from each patient, altogether 80 series, were presented anonymously and in a random order. Five observers rated the quality of the reconstructed section images according to predefined quality criteria in three different classes. Visual grading characteristics (VGC) was used to analyse the data and the area under the VGC curve (AUC VGC ) was used as figure-of-merit. The 12 s protocol and the standard DTS processing were used as references in the analyses. The protocol with 6.3 s acquisition time had a statistically significant advantage over the vendor-recommended protocol with 12 s acquisition time for the classes of criteria, Demarcation (AUC VGC = 0.56, p = 0.009) and Disturbance (AUC VGC = 0.58, p < 0.001). A similar value of AUC VGC was found also for the class Structure (definition of bone structures in the spine) (0.56) but it could not be statistically separated from 0.5 (p = 0.21). For the image processing, the VGC analysis showed a small but statistically significant advantage for the standard DTS processing over the more advanced processing for the classes of criteria Demarcation (AUC VGC = 0.45, p = 0.017) and Disturbance (AUC VGC = 0.43, p = 0.005). A similar value of AUC VGC was found also for the class Structure (0.46), but it could not be statistically separated from 0.5 (p = 0.31). The study indicates that the protocol with 6.3 s acquisition time yields slightly better image quality than the vender-recommended protocol with acquisition time 12 s for several anatomical structures. Furthermore, the standard gradation processing  (the vendor-recommended post-processing for DTS), yields to some extent advantage over the gradation processing/multiobjective frequency processing/flexible noise control processing in terms of image quality for all classes of criteria. Advances in knowledge: The study proves that the image quality may be strongly affected by the selection of DTS protocol and that the vendor-recommended protocol may not always be the optimal choice.

Sensitive Quantitative Assessment of Balance Disorders

NASA Technical Reports Server (NTRS)

Paloski, Willilam H.

2007-01-01

Computerized dynamic posturography (CDP) has become a standard technique for objectively quantifying balance control performance, diagnosing the nature of functional impairments underlying balance disorders, and monitoring clinical treatment outcomes. We have long used CDP protocols to assess recovery of sensory-motor function in astronauts following space flight. The most reliable indicators of post-flight crew performance are the sensory organization tests (SOTs), particularly SOTs 5 and 6, which are sensitive to changes in availability and/or utilization of vestibular cues. We have noted, however, that some astronauts exhibiting obvious signs of balance impairment after flight are able to score within clinical norms on these tests, perhaps as a result of adopting competitive strategies or by their natural skills at substituting alternate sensory information sources. This insensitivity of the CDP protocol could underestimate of the degree of impairment and, perhaps, lead to premature release of those crewmembers to normal duties. To improve the sensitivity of the CDP protocol we have introduced static and dynamic head tilt SOT trials into our protocol. The pattern of postflight recovery quantified by the enhanced CDP protocol appears to more aptly track the re-integration of sensory-motor function, with recovery time increasing as the complexity of sensory-motor/biomechanical task increases. The new CDP protocol therefore seems more suitable for monitoring post-flight sensory-motor recovery and for indicating to crewmembers and flight surgeons fitness for return to duty and/or activities of daily living. There may be classes of patients (e.g., athletes, pilots) having motivation and/or performance characteristics similar to astronauts whose sensory-motor treatment outcomes would also be more accurately monitored using the enhanced CDP protocol. Furthermore, the enhanced protocol may be useful in early detection of age-related balance disorders.

Standardization and performance evaluation of "modified" and "ultrasensitive" versions of the Abbott RealTime HIV-1 assay, adapted to quantify minimal residual viremia.

PubMed

Amendola, Alessandra; Bloisi, Maria; Marsella, Patrizia; Sabatini, Rosella; Bibbò, Angela; Angeletti, Claudio; Capobianchi, Maria Rosaria

2011-09-01

Numerous studies investigating clinical significance of HIV-1 minimal residual viremia (MRV) suggest potential utility of assays more sensitive than those routinely used to monitor viral suppression. However currently available methods, based on different technologies, show great variation in detection limit and input plasma volume, and generally suffer from lack of standardization. In order to establish new tools suitable for routine quantification of minimal residual viremia in patients under virological suppression, some modifications were introduced into standard procedure of the Abbott RealTime HIV-1 assay leading to a "modified" and an "ultrasensitive" protocols. The following modifications were introduced: calibration curve extended towards low HIV-1 RNA concentration; 4 fold increased sample volume by concentrating starting material; reduced volume of internal control; adoption of "open-mode" software for quantification. Analytical performances were evaluated using the HIV-1 RNA Working Reagent 1 for NAT assays (NIBSC). Both tests were applied to clinical samples from virologically suppressed patients. The "modified" and the "ultrasensitive" configurations of the assay reached a limit of detection of 18.8 (95% CI: 11.1-51.0 cp/mL) and 4.8 cp/mL (95% CI: 2.6-9.1 cp/mL), respectively, with high precision and accuracy. In clinical samples from virologically suppressed patients, "modified" and "ultrasensitive" protocols allowed to detect and quantify HIV RNA in 12.7% and 46.6%, respectively, of samples resulted "not-detectable", and in 70.0% and 69.5%, respectively, of samples "detected <40 cp/mL" in the standard assay. The "modified" and "ultrasensitive" assays are precise and accurate, and easily adoptable in routine diagnostic laboratories for measuring MRV. Copyright © 2011 Elsevier B.V. All rights reserved.

Similarity-based modeling in large-scale prediction of drug-drug interactions.

PubMed

Vilar, Santiago; Uriarte, Eugenio; Santana, Lourdes; Lorberbaum, Tal; Hripcsak, George; Friedman, Carol; Tatonetti, Nicholas P

2014-09-01

Drug-drug interactions (DDIs) are a major cause of adverse drug effects and a public health concern, as they increase hospital care expenses and reduce patients' quality of life. DDI detection is, therefore, an important objective in patient safety, one whose pursuit affects drug development and pharmacovigilance. In this article, we describe a protocol applicable on a large scale to predict novel DDIs based on similarity of drug interaction candidates to drugs involved in established DDIs. The method integrates a reference standard database of known DDIs with drug similarity information extracted from different sources, such as 2D and 3D molecular structure, interaction profile, target and side-effect similarities. The method is interpretable in that it generates drug interaction candidates that are traceable to pharmacological or clinical effects. We describe a protocol with applications in patient safety and preclinical toxicity screening. The time frame to implement this protocol is 5-7 h, with additional time potentially necessary, depending on the complexity of the reference standard DDI database and the similarity measures implemented.

Model-based Iterative Reconstruction: Effect on Patient Radiation Dose and Image Quality in Pediatric Body CT

PubMed Central

Dillman, Jonathan R.; Goodsitt, Mitchell M.; Christodoulou, Emmanuel G.; Keshavarzi, Nahid; Strouse, Peter J.

2014-01-01

Purpose To retrospectively compare image quality and radiation dose between a reduced-dose computed tomographic (CT) protocol that uses model-based iterative reconstruction (MBIR) and a standard-dose CT protocol that uses 30% adaptive statistical iterative reconstruction (ASIR) with filtered back projection. Materials and Methods Institutional review board approval was obtained. Clinical CT images of the chest, abdomen, and pelvis obtained with a reduced-dose protocol were identified. Images were reconstructed with two algorithms: MBIR and 100% ASIR. All subjects had undergone standard-dose CT within the prior year, and the images were reconstructed with 30% ASIR. Reduced- and standard-dose images were evaluated objectively and subjectively. Reduced-dose images were evaluated for lesion detectability. Spatial resolution was assessed in a phantom. Radiation dose was estimated by using volumetric CT dose index (CTDIvol) and calculated size-specific dose estimates (SSDE). A combination of descriptive statistics, analysis of variance, and t tests was used for statistical analysis. Results In the 25 patients who underwent the reduced-dose protocol, mean decrease in CTDIvol was 46% (range, 19%–65%) and mean decrease in SSDE was 44% (range, 19%–64%). Reduced-dose MBIR images had less noise (P > .004). Spatial resolution was superior for reduced-dose MBIR images. Reduced-dose MBIR images were equivalent to standard-dose images for lungs and soft tissues (P > .05) but were inferior for bones (P = .004). Reduced-dose 100% ASIR images were inferior for soft tissues (P < .002), lungs (P < .001), and bones (P < .001). By using the same reduced-dose acquisition, lesion detectability was better (38% [32 of 84 rated lesions]) or the same (62% [52 of 84 rated lesions]) with MBIR as compared with 100% ASIR. Conclusion CT performed with a reduced-dose protocol and MBIR is feasible in the pediatric population, and it maintains diagnostic quality. © RSNA, 2013 Online supplemental material is available for this article. PMID:24091359

Assessment of Diverse Biological Indicators in Gulf War Illness: Are They Replicable Are They Related

DTIC Science & Technology

2016-04-01

compared to 50 healthy veteran controls in a protocol that includes physical and neuropsychological evaluations, neuroimaging (MRI, fMRI, DTI), adrenal...SUBJECT TERMS Gulf War illness, neuroimaging, neuropsychological testing, immune function, hypothalamic-pituitary-adrenal testing 16. SECURITY... neuropsychological evaluations, assessment of hypothalamic-pituitary-adrenal function, standard clinical diagnostic laboratory tests, and research

Dynamic whole body PET parametric imaging: II. Task-oriented statistical estimation

PubMed Central

Karakatsanis, Nicolas A.; Lodge, Martin A.; Zhou, Y.; Wahl, Richard L.; Rahmim, Arman

2013-01-01

In the context of oncology, dynamic PET imaging coupled with standard graphical linear analysis has been previously employed to enable quantitative estimation of tracer kinetic parameters of physiological interest at the voxel level, thus, enabling quantitative PET parametric imaging. However, dynamic PET acquisition protocols have been confined to the limited axial field-of-view (~15–20cm) of a single bed position and have not been translated to the whole-body clinical imaging domain. On the contrary, standardized uptake value (SUV) PET imaging, considered as the routine approach in clinical oncology, commonly involves multi-bed acquisitions, but is performed statically, thus not allowing for dynamic tracking of the tracer distribution. Here, we pursue a transition to dynamic whole body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. In a companion study, we presented a novel clinically feasible dynamic (4D) multi-bed PET acquisition protocol as well as the concept of whole body PET parametric imaging employing Patlak ordinary least squares (OLS) regression to estimate the quantitative parameters of tracer uptake rate Ki and total blood distribution volume V. In the present study, we propose an advanced hybrid linear regression framework, driven by Patlak kinetic voxel correlations, to achieve superior trade-off between contrast-to-noise ratio (CNR) and mean squared error (MSE) than provided by OLS for the final Ki parametric images, enabling task-based performance optimization. Overall, whether the observer's task is to detect a tumor or quantitatively assess treatment response, the proposed statistical estimation framework can be adapted to satisfy the specific task performance criteria, by adjusting the Patlak correlation-coefficient (WR) reference value. The multi-bed dynamic acquisition protocol, as optimized in the preceding companion study, was employed along with extensive Monte Carlo simulations and an initial clinical FDG patient dataset to validate and demonstrate the potential of the proposed statistical estimation methods. Both simulated and clinical results suggest that hybrid regression in the context of whole-body Patlak Ki imaging considerably reduces MSE without compromising high CNR. Alternatively, for a given CNR, hybrid regression enables larger reductions than OLS in the number of dynamic frames per bed, allowing for even shorter acquisitions of ~30min, thus further contributing to the clinical adoption of the proposed framework. Compared to the SUV approach, whole body parametric imaging can provide better tumor quantification, and can act as a complement to SUV, for the task of tumor detection. PMID:24080994

Dynamic whole-body PET parametric imaging: II. Task-oriented statistical estimation.

PubMed

Karakatsanis, Nicolas A; Lodge, Martin A; Zhou, Y; Wahl, Richard L; Rahmim, Arman

2013-10-21

In the context of oncology, dynamic PET imaging coupled with standard graphical linear analysis has been previously employed to enable quantitative estimation of tracer kinetic parameters of physiological interest at the voxel level, thus, enabling quantitative PET parametric imaging. However, dynamic PET acquisition protocols have been confined to the limited axial field-of-view (~15-20 cm) of a single-bed position and have not been translated to the whole-body clinical imaging domain. On the contrary, standardized uptake value (SUV) PET imaging, considered as the routine approach in clinical oncology, commonly involves multi-bed acquisitions, but is performed statically, thus not allowing for dynamic tracking of the tracer distribution. Here, we pursue a transition to dynamic whole-body PET parametric imaging, by presenting, within a unified framework, clinically feasible multi-bed dynamic PET acquisition protocols and parametric imaging methods. In a companion study, we presented a novel clinically feasible dynamic (4D) multi-bed PET acquisition protocol as well as the concept of whole-body PET parametric imaging employing Patlak ordinary least squares (OLS) regression to estimate the quantitative parameters of tracer uptake rate Ki and total blood distribution volume V. In the present study, we propose an advanced hybrid linear regression framework, driven by Patlak kinetic voxel correlations, to achieve superior trade-off between contrast-to-noise ratio (CNR) and mean squared error (MSE) than provided by OLS for the final Ki parametric images, enabling task-based performance optimization. Overall, whether the observer's task is to detect a tumor or quantitatively assess treatment response, the proposed statistical estimation framework can be adapted to satisfy the specific task performance criteria, by adjusting the Patlak correlation-coefficient (WR) reference value. The multi-bed dynamic acquisition protocol, as optimized in the preceding companion study, was employed along with extensive Monte Carlo simulations and an initial clinical (18)F-deoxyglucose patient dataset to validate and demonstrate the potential of the proposed statistical estimation methods. Both simulated and clinical results suggest that hybrid regression in the context of whole-body Patlak Ki imaging considerably reduces MSE without compromising high CNR. Alternatively, for a given CNR, hybrid regression enables larger reductions than OLS in the number of dynamic frames per bed, allowing for even shorter acquisitions of ~30 min, thus further contributing to the clinical adoption of the proposed framework. Compared to the SUV approach, whole-body parametric imaging can provide better tumor quantification, and can act as a complement to SUV, for the task of tumor detection.

Targeted Full Energy and Protein Delivery in Critically Ill Patients: A Pilot Randomized Controlled Trial (FEED Trial).

PubMed

Fetterplace, Kate; Deane, Adam M; Tierney, Audrey; Beach, Lisa J; Knight, Laura D; Presneill, Jeffrey; Rechnitzer, Thomas; Forsyth, Adrienne; Gill, Benjamin M T; Mourtzakis, Marina; MacIsaac, Christopher

2018-04-27

International guidelines recommend greater protein delivery to critically ill patients than they currently receive. This pilot randomized clinical trial aimed to determine whether a volume-target enteral protocol with supplemental protein delivered greater amounts of protein and energy to critically ill patients compared with standard care. Sixty participants received either the intervention (volume-based protocol, with protein supplementation) or standard nutrition care (hourly-rate-based protocol, without protein supplementation) in the intensive care unit (ICU). Coprimary outcomes were average daily protein and energy delivery. Secondary outcomes included change in quadriceps muscle layer thickness (QMLT, ultrasound) and malnutrition (subjective global assessment) at ICU discharge. Mean (SD) protein and energy delivery per day from nutrition therapy for the intervention were 1.2 (0.30) g/kg and 21 (5.2) kcal/kg compared with 0.75 (0.11) g/kg and 18 (2.7) kcal/kg for standard care. The mean difference between groups in protein and energy delivery per day was 0.45 g/kg (95% CI, 0.33-0.56; P < .001) and 2.8 kcal/kg (95% CI, 0.67-4.9, P = .01). Muscle loss (QMLT) at discharge was attenuated by 0.22 cm (95% CI, 0.06-0.38, P = .01) in patients receiving the intervention compared with standard care. The number of malnourished patients was fewer in the intervention [2 (7%) vs 8 (28%); P = .04]. Mortality and duration of admission were similar between groups. A high-protein volume-based protocol with protein supplementation delivered greater amounts of protein and energy. This intervention was associated with attenuation of QMLT loss and reduced prevalence of malnutrition at ICU discharge. © 2018 American Society for Parenteral and Enteral Nutrition.

Optimized protocol for quantitative multiple reaction monitoring-based proteomic analysis of formalin-fixed, paraffin embedded tissues

PubMed Central

Kennedy, Jacob J.; Whiteaker, Jeffrey R.; Schoenherr, Regine M.; Yan, Ping; Allison, Kimberly; Shipley, Melissa; Lerch, Melissa; Hoofnagle, Andrew N.; Baird, Geoffrey Stuart; Paulovich, Amanda G.

2016-01-01

Despite a clinical, economic, and regulatory imperative to develop companion diagnostics, precious few new biomarkers have been successfully translated into clinical use, due in part to inadequate protein assay technologies to support large-scale testing of hundreds of candidate biomarkers in formalin-fixed paraffin embedded (FFPE) tissues. While the feasibility of using targeted, multiple reaction monitoring-mass spectrometry (MRM-MS) for quantitative analyses of FFPE tissues has been demonstrated, protocols have not been systematically optimized for robust quantification across a large number of analytes, nor has the performance of peptide immuno-MRM been evaluated. To address this gap, we used a test battery approach coupled to MRM-MS with the addition of stable isotope labeled standard peptides (targeting 512 analytes) to quantitatively evaluate the performance of three extraction protocols in combination with three trypsin digestion protocols (i.e. 9 processes). A process based on RapiGest buffer extraction and urea-based digestion was identified to enable similar quantitation results from FFPE and frozen tissues. Using the optimized protocols for MRM-based analysis of FFPE tissues, median precision was 11.4% (across 249 analytes). There was excellent correlation between measurements made on matched FFPE and frozen tissues, both for direct MRM analysis (R2 = 0.94) and immuno-MRM (R2 = 0.89). The optimized process enables highly reproducible, multiplex, standardizable, quantitative MRM in archival tissue specimens. PMID:27462933

Treatment of Middle East Respiratory Syndrome with a combination of lopinavir-ritonavir and interferon-β1b (MIRACLE trial): study protocol for a randomized controlled trial.

PubMed

Arabi, Yaseen M; Alothman, Adel; Balkhy, Hanan H; Al-Dawood, Abdulaziz; AlJohani, Sameera; Al Harbi, Shmeylan; Kojan, Suleiman; Al Jeraisy, Majed; Deeb, Ahmad M; Assiri, Abdullah M; Al-Hameed, Fahad; AlSaedi, Asim; Mandourah, Yasser; Almekhlafi, Ghaleb A; Sherbeeni, Nisreen Murad; Elzein, Fatehi Elnour; Memon, Javed; Taha, Yusri; Almotairi, Abdullah; Maghrabi, Khalid A; Qushmaq, Ismael; Al Bshabshe, Ali; Kharaba, Ayman; Shalhoub, Sarah; Jose, Jesna; Fowler, Robert A; Hayden, Frederick G; Hussein, Mohamed A

2018-01-30

It had been more than 5 years since the first case of Middle East Respiratory Syndrome coronavirus infection (MERS-CoV) was recorded, but no specific treatment has been investigated in randomized clinical trials. Results from in vitro and animal studies suggest that a combination of lopinavir/ritonavir and interferon-β1b (IFN-β1b) may be effective against MERS-CoV. The aim of this study is to investigate the efficacy of treatment with a combination of lopinavir/ritonavir and recombinant IFN-β1b provided with standard supportive care, compared to treatment with placebo provided with standard supportive care in patients with laboratory-confirmed MERS requiring hospital admission. The protocol is prepared in accordance with the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. Hospitalized adult patients with laboratory-confirmed MERS will be enrolled in this recursive, two-stage, group sequential, multicenter, placebo-controlled, double-blind randomized controlled trial. The trial is initially designed to include 2 two-stage components. The first two-stage component is designed to adjust sample size and determine futility stopping, but not efficacy stopping. The second two-stage component is designed to determine efficacy stopping and possibly readjustment of sample size. The primary outcome is 90-day mortality. This will be the first randomized controlled trial of a potential treatment for MERS. The study is sponsored by King Abdullah International Medical Research Center, Riyadh, Saudi Arabia. Enrollment for this study began in November 2016, and has enrolled thirteen patients as of Jan 24-2018. ClinicalTrials.gov, ID: NCT02845843 . Registered on 27 July 2016.

Short- and long-term clinical outcomes following a standardized protocol of orthopedic manual physical therapy and exercise in individuals with osteoarthritis of the hip: a case series

PubMed Central

Hando, Ben R; Gill, Norman W; Walker, Michael J; Garber, Mathew

2012-01-01

Objectives: Describe short- and long-term outcomes observed in individuals with hip osteoarthritis (OA) treated with a pre-selected, standardized set of best-evidence manual therapy and therapeutic exercise interventions. Methods: Fifteen consecutive subjects (9 males, 6 females; mean age: 52±7.5 years) with unilateral hip OA received an identical protocol of manual therapy and therapeutic exercise interventions. Subjects attended 10 treatment sessions over an 8-week period for manual therapy interventions and performed the therapeutic exercise as a home program. Results: Baseline to 8-week follow-up outcomes were as follows: Harris Hip Scale (HHS) scores improved from 60.3(±10.4) to 80.7(±10.5), Numerical Pain Rating Scale (NPRS) scores improved from 4.3(±1.9) to 2.0(±1.9), hip flexion range of motion (ROM) improved from 99 degrees (±10.6) to 127 degrees (±6.3) and hip internal rotation ROM improved from 19 degrees (±9.1) to 31 degrees (±11.5). Improvements in HHS, NPRS, and hip ROM measures reached statistical significance (P<0.05) at 8-weeks and remained significant at the 29-week follow-up. Mean changes in NPRS and HHS scores exceeded the minimal clinically important difference (MCID) at 8-weeks and for the HHS scores alone at 29 weeks. The 8 and 29 week mean Global Rating of Change scores were 5.1(±1.4) and 2.1(±4.2), respectively. Improved outcomes observed following a pre-selected, standardized treatment protocol were similar to those observed in previous studies involving impairment-based manual therapy and therapeutic exercise for hip OA. Future studies might directly compare the two approaches. Discussion: PMID:24179327

Short- and long-term clinical outcomes following a standardized protocol of orthopedic manual physical therapy and exercise in individuals with osteoarthritis of the hip: a case series.

PubMed

Hando, Ben R; Gill, Norman W; Walker, Michael J; Garber, Mathew

2012-11-01

Describe short- and long-term outcomes observed in individuals with hip osteoarthritis (OA) treated with a pre-selected, standardized set of best-evidence manual therapy and therapeutic exercise interventions. Fifteen consecutive subjects (9 males, 6 females; mean age: 52±7.5 years) with unilateral hip OA received an identical protocol of manual therapy and therapeutic exercise interventions. Subjects attended 10 treatment sessions over an 8-week period for manual therapy interventions and performed the therapeutic exercise as a home program. Baseline to 8-week follow-up outcomes were as follows: Harris Hip Scale (HHS) scores improved from 60.3(±10.4) to 80.7(±10.5), Numerical Pain Rating Scale (NPRS) scores improved from 4.3(±1.9) to 2.0(±1.9), hip flexion range of motion (ROM) improved from 99 degrees (±10.6) to 127 degrees (±6.3) and hip internal rotation ROM improved from 19 degrees (±9.1) to 31 degrees (±11.5). Improvements in HHS, NPRS, and hip ROM measures reached statistical significance (P<0.05) at 8-weeks and remained significant at the 29-week follow-up. Mean changes in NPRS and HHS scores exceeded the minimal clinically important difference (MCID) at 8-weeks and for the HHS scores alone at 29 weeks. The 8 and 29 week mean Global Rating of Change scores were 5.1(±1.4) and 2.1(±4.2), respectively. Improved outcomes observed following a pre-selected, standardized treatment protocol were similar to those observed in previous studies involving impairment-based manual therapy and therapeutic exercise for hip OA. Future studies might directly compare the two approaches.

The pluralization of the international: Resistance and alter-standardization in regenerative stem cell medicine

PubMed Central

Rosemann, Achim; Chaisinthop, Nattaka

2016-01-01

The article explores the formation of an international politics of resistance and ‘alter-standardization’ in regenerative stem cell medicine. The absence of internationally harmonized regulatory frameworks in the clinical stem cell field and the presence of lucrative business opportunities have resulted in the formation of transnational networks adopting alternative research standards and practices. These oppose, as a universal global standard, strict evidence-based medicine clinical research protocols as defined by scientists and regulatory agencies in highly developed countries. The emergence of transnational spaces of alter-standardization is closely linked to scientific advances in rapidly developing countries such as China and India, but calls for more flexible regulatory frameworks, and the legitimization of experimental for-profit applications outside of evidence-based medical care, are emerging increasingly also within more stringently regulated countries, such as the United States and countries in the European Union. We can observe, then, a trend toward the pluralization of the standards, practices, and concepts in the stem cell field. PMID:26983174

Sequence optimization to reduce velocity offsets in cardiovascular magnetic resonance volume flow quantification - A multi-vendor study

PubMed Central

2011-01-01

Purpose Eddy current induced velocity offsets are of concern for accuracy in cardiovascular magnetic resonance (CMR) volume flow quantification. However, currently known theoretical aspects of eddy current behavior have not led to effective guidelines for the optimization of flow quantification sequences. This study is aimed at identifying correlations between protocol parameters and the resulting velocity error in clinical CMR flow measurements in a multi-vendor study. Methods Nine 1.5T scanners of three different types/vendors were studied. Measurements were performed on a large stationary phantom. Starting from a clinical breath-hold flow protocol, several protocol parameters were varied. Acquisitions were made in three clinically relevant orientations. Additionally, a time delay between the bipolar gradient and read-out, asymmetric versus symmetric velocity encoding, and gradient amplitude and slew rate were studied in adapted sequences as exploratory measurements beyond the protocol. Image analysis determined the worst-case offset for a typical great-vessel flow measurement. Results The results showed a great variation in offset behavior among scanners (standard deviation among samples of 0.3, 0.4, and 0.9 cm/s for the three different scanner types), even for small changes in the protocol. Considering the absolute values, none of the tested protocol settings consistently reduced the velocity offsets below the critical level of 0.6 cm/s neither for all three orientations nor for all three scanner types. Using multilevel linear model analysis, oblique aortic and pulmonary slices showed systematic higher offsets than the transverse aortic slices (oblique aortic 0.6 cm/s, and pulmonary 1.8 cm/s higher than transverse aortic). The exploratory measurements beyond the protocol yielded some new leads for further sequence development towards reduction of velocity offsets; however those protocols were not always compatible with the time-constraints of breath-hold imaging and flow-related artefacts. Conclusions This study showed that with current systems there was no generic protocol which resulted into acceptable flow offset values. Protocol optimization would have to be performed on a per scanner and per protocol basis. Proper optimization might make accurate (transverse) aortic flow quantification possible for most scanners. Pulmonary flow quantification would still need further (offline) correction. PMID:21388521

Randomized controlled trial of accelerated rehabilitation versus standard protocol following surgical repair of ruptured Achilles tendon.

PubMed

Porter, Mark D; Shadbolt, Bruce

2015-05-01

There is no consensus regarding the optimal management of the acutely ruptured Achilles tendon (TA). Functional bracing alone achieves outcomes similar to those of surgical repair. Surgical repair combined with immediate mobilization may improve the clinical outcome further. The purpose of our study was to determine if an accelerated rehabilitation programme following surgical repair of the ruptured TA could improve clinical outcome, relative to the standard protocol. Patients with an acutely ruptured TA were randomly allocated to undergo an accelerated programme (AP) or standard programme (SP), following surgery. Outcome was assessed at 12 months post-surgery using the Achilles tendon Total Rupture Score (ATRS), the heel-raise height and the time taken to return to running. Fifty-one patients completed the study, 25 in the AP group and 26 in the SP group. At 12 months post-surgery, the ATRS results were similar in the two treatment groups (87.46 in AP with standard error (SE) of 0.735 versus 87.12 in SP with SE of 0.75) while the AP group had less lengthening of the TA (0.385 cm, SE 0.166 versus 1.00 cm, SE 0.169) and a more rapid return to running (17.231 weeks, SE 0.401 versus 21.08 weeks, SE 0.409), than the SP group. The accelerated rehabilitation programme resulted in less tendon lengthening, more rapid return to running, but similar ATRS relative to the standard rehabilitation. Immobilization following TA repair may prolong recovery. © 2014 Royal Australasian College of Surgeons.

Protocol standards and implementation within the digital engineering laboratory computer network (DELNET) using the universal network interface device (UNID). Part 2

NASA Astrophysics Data System (ADS)

Phister, P. W., Jr.

1983-12-01

Development of the Air Force Institute of Technology's Digital Engineering Laboratory Network (DELNET) was continued with the development of an initial draft of a protocol standard for all seven layers as specified by the International Standards Organization's (ISO) Reference Model for Open Systems Interconnections. This effort centered on the restructuring of the Network Layer to perform Datagram routing and to conform to the developed protocol standards and actual software module development of the upper four protocol layers residing within the DELNET Monitor (Zilog MCZ 1/25 Computer System). Within the guidelines of the ISO Reference Model the Transport Layer was developed utilizing the Internet Header Format (IHF) combined with the Transport Control Protocol (TCP) to create a 128-byte Datagram. Also a limited Application Layer was created to pass the Gettysburg Address through the DELNET. This study formulated a first draft for the DELNET Protocol Standard and designed, implemented, and tested the Network, Transport, and Application Layers to conform to these protocol standards.

Human platelet lysate in mesenchymal stromal cell expansion according to a GMP grade protocol: a cell factory experience.

PubMed

Becherucci, Valentina; Piccini, Luisa; Casamassima, Serena; Bisin, Silvia; Gori, Valentina; Gentile, Francesca; Ceccantini, Riccardo; De Rienzo, Elena; Bindi, Barbara; Pavan, Paola; Cunial, Vanessa; Allegro, Elisa; Ermini, Stefano; Brugnolo, Francesca; Astori, Giuseppe; Bambi, Franco

2018-05-02

The use of platelet lysate (PL) for the ex-vivo expansion of mesenchymal stromal/stem cells (MSCs) was initially proposed by Doucet et al. in 2005, as an alternative to animal serum. Moreover, regulatory authorities discourage the use of fetal bovine serum (FBS) or other animal derivatives, to avoid risk of zoonoses and xenogeneic immune reactions. Even if many studies investigated PL composition, there still are some open issues related to its use in ex-vivo MSC expansion, especially according to good manufacturing practice (GMP) grade protocols. As an authorized cell factory, we report our experience using standardized PL produced by Azienda Ospedaliero Universitaria Meyer Transfusion Service for MSC expansion according to a GMP grade clinical protocol. As suggested by other authors, we performed an in-vitro test on MSCs versus MSCs cultured with FBS that still represents the best way to test PL batches. We compared 12 MSC batches cultured with DMEM 5% PL with similar batches cultured with DMEM 10% FBS, focusing on the MSC proliferation rate, MSC surface marker expression, MSC immunomodulatory and differentiation potential, and finally MSC relative telomere length. Results confirmed the literature data as PL increases cell proliferation without affecting the MSC immunophenotype, immunomodulatory potential, differentiation potential and relative telomere length. PL can be considered a safe alternative to FBS for ex-vivo expansion of MSC according to a GMP grade protocol. Our experience confirms the literature data: a large number of MSCs for clinical applications can be obtained by expansion with PL, without affecting the MSC main features. Our experience underlines the benefits of a close collaboration between the PL producers (transfusion service) and the end users (cell factory) in a synergy of skills and experiences that can lead to standardized PL production.

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery

PubMed Central

Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-01-01

Introduction Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions—physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. Methods and analysis This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. Ethics and dissemination This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. Trial registration number NCT02921932 (ClinicalTrials.gov) PMID:28778994

Protocol for a single-centre, randomised controlled study of a preoperative rehabilitation bundle in the frail and elderly undergoing abdominal surgery.

PubMed

Abdullah, Hairil Rizal; Lien, Victoria Peixin; Ong, Hwee Kuan; Er, Pei Ling; Hao, Ying; Khan, Shariq Ali; Liu, Christopher Weiyang

2017-08-04

Frail patients have decreased physiological reserves and consequently, they are unable to recover as quickly from surgery. Frailty, as an entity, is a risk factor of increased morbidity and mortality. It is also associated with a longer time to discharge. This trial is undertaken to determine if a novel prehabilitation protocol (10-day bundle of interventions-physiotherapy, nutritional supplementation and cognitive training) can reduce the postoperative length of stay of frail patients who are undergoing elective abdominal surgery, compared with standard care. This is a prospective, single-centre, randomised controlled trial with two parallel arms. 62 patients who are frail and undergoing elective abdominal surgery will be recruited and randomised to receive either a novel prehabilitation protocol or standard care. Participants will receive telephone reminders preoperatively to encourage protocol compliance. Data will be collected for up to 30 days postoperatively. The primary outcome of the trial will be the postoperative length of stay and the secondary outcomes are the postoperative complications and functional recovery during the hospital admission. This study has been approved by the Singapore General Hospital Institutional Review Board (CIRB Ref: 2016/2584). The study is also listed on ClinicalTrials.gov (Trial number: NCT02921932). All participants will sign an informed consent form before randomisation and translators will be made available to non-English speaking patients. The results of this study will be published in peer-reviewed journals as well as national and international conferences. The data collected will also be made available in a public data repository. NCT02921932 (ClinicalTrials.gov). © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

SMART on FHIR Genomics: facilitating standardized clinico-genomic apps.

PubMed

Alterovitz, Gil; Warner, Jeremy; Zhang, Peijin; Chen, Yishen; Ullman-Cullere, Mollie; Kreda, David; Kohane, Isaac S

2015-11-01

Supporting clinical decision support for personalized medicine will require linking genome and phenome variants to a patient's electronic health record (EHR), at times on a vast scale. Clinico-genomic data standards will be needed to unify how genomic variant data are accessed from different sequencing systems. A specification for the basis of a clinic-genomic standard, building upon the current Health Level Seven International Fast Healthcare Interoperability Resources (FHIR®) standard, was developed. An FHIR application protocol interface (API) layer was attached to proprietary sequencing platforms and EHRs in order to expose gene variant data for presentation to the end-user. Three representative apps based on the SMART platform were built to test end-to-end feasibility, including integration of genomic and clinical data. Successful design, deployment, and use of the API was demonstrated and adopted by HL7 Clinical Genomics Workgroup. Feasibility was shown through development of three apps by various types of users with background levels and locations. This prototyping work suggests that an entirely data (and web) standards-based approach could prove both effective and efficient for advancing personalized medicine. © The Author 2015. Published by Oxford University Press on behalf of the American Medical Informatics Association. All rights reserved. For Permissions, please email: journals.permissions@oup.com.

Multicenter evaluation of stress-first myocardial perfusion image triage by nuclear technologists and automated quantification.

PubMed

Chaudhry, Waseem; Hussain, Nasir; Ahlberg, Alan W; Croft, Lori B; Fernandez, Antonio B; Parker, Mathew W; Swales, Heather H; Slomka, Piotr J; Henzlova, Milena J; Duvall, W Lane

2017-06-01

A stress-first myocardial perfusion imaging (MPI) protocol saves time, is cost effective, and decreases radiation exposure. A limitation of this protocol is the requirement for physician review of the stress images to determine the need for rest images. This hurdle could be eliminated if an experienced technologist and/or automated computer quantification could make this determination. Images from consecutive patients who were undergoing a stress-first MPI with attenuation correction at two tertiary care medical centers were prospectively reviewed independently by a technologist and cardiologist blinded to clinical and stress test data. Their decision on the need for rest imaging along with automated computer quantification of perfusion results was compared with the clinical reference standard of an assessment of perfusion images by a board-certified nuclear cardiologist that included clinical and stress test data. A total of 250 patients (mean age 61 years and 55% female) who underwent a stress-first MPI were studied. According to the clinical reference standard, 42 (16.8%) and 208 (83.2%) stress-first images were interpreted as "needing" and "not needing" rest images, respectively. The technologists correctly classified 229 (91.6%) stress-first images as either "needing" (n = 28) or "not needing" (n = 201) rest images. Their sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 66.7%, 96.6%, 80.0%, and 93.5%, respectively. An automated stress TPD score ≥1.2 was associated with optimal sensitivity and specificity and correctly classified 179 (71.6%) stress-first images as either "needing" (n = 31) or "not needing" (n = 148) rest images. Its sensitivity, specificity, PPV, and NPV were 73.8%, 71.2%, 34.1%, and 93.1%, respectively. In a model whereby the computer or technologist could correct for the other's incorrect classification, 242 (96.8%) stress-first images were correctly classified. The composite sensitivity, specificity, PPV, and NPV were 83.3%, 99.5%, 97.2%, and 96.7%, respectively. Technologists and automated quantification software had a high degree of agreement with the clinical reference standard for determining the need for rest images in a stress-first imaging protocol. Utilizing an experienced technologist and automated systems to screen stress-first images could expand the use of stress-first MPI to sites where the cardiologist is not immediately available for interpretation.

[Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

PubMed

Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

2018-01-01

 Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

Novel methods of imaging and analysis for the thermoregulatory sweat test.

PubMed

Carroll, Michael Sean; Reed, David W; Kuntz, Nancy L; Weese-Mayer, Debra Ellyn

2018-06-07

The thermoregulatory sweat test (TST) can be central to the identification and management of disorders affecting sudomotor function and small sensory and autonomic nerve fibers, but the cumbersome nature of the standard testing protocol has prevented its widespread adoption. A high resolution, quantitative, clean and simple assay of sweating could significantly improve identification and management of these disorders. Images from 89 clinical TSTs were analyzed retrospectively using two novel techniques. First, using the standard indicator powder, skin surface sweat distributions were determined algorithmically for each patient. Second, a fundamentally novel method using thermal imaging of forced evaporative cooling was evaluated through comparison with the standard technique. Correlation and receiver operating characteristic analyses were used to determine the degree of match between these methods, and the potential limits of thermal imaging were examined through cumulative analysis of all studied patients. Algorithmic encoding of sweating and non-sweating regions produces a more objective analysis for clinical decision making. Additionally, results from the forced cooling method correspond well with those from indicator powder imaging, with a correlation across spatial regions of -0.78 (CI: -0.84 to -0.71). The method works similarly across body regions, and frame-by-frame analysis suggests the ability to identify sweating regions within about 1 second of imaging. While algorithmic encoding can enhance the standard sweat testing protocol, thermal imaging with forced evaporative cooling can dramatically improve the TST by making it less time-consuming and more patient-friendly than the current approach.

“Early Trigger” Intravenous Vitamin K

PubMed Central

Diament, Marina; MacLeod, Kirsty; O’Hare, Jonathan; Tate, Anne

2015-01-01

Best practice tariff (BPT) was introduced as a financial incentive model to improve compliance with evidence-based care, such as operation for hip fracture within 36 hours of admission. We previously evaluated the impact of warfarin on patients with hip fracture, revealing significant delay to operation and subsequent loss of revenue. As a result of this, an “early trigger” intravenous vitamin K (IVK) pathway was introduced and the service reaudited a year later. The first cycle was a retrospective audit of all cases with hip fracture against BPT standards over a 32-month period. Subsequent protocol change resulted in all warfarinised cases being given 2 mg IVK in the emergency department prior to blood testing. This protocol was reaudited against the same BPT standards 12 months later. An intention-to-treat approach was used, despite breaches of protocol and other reasons for patients not progressing to theater. The data were analyzed with parametric tools to establish true clinical and statistical impact of the introduction of the protocol. In the first cycle, 80 patients were admitted on warfarin with a mean time to theater of 53.71 hours. Of these patients, 79% breached BPT due to anticoagulation. Twelve months following protocol introduction, 42 patients had a mean time to theater of 37.61 hours. Of these patients, 34% breached BPT due to anticoagulation. These data are both clinically and statistically significant (P < .001). No adverse events occurred. We have shown for the first time that “early-trigger” IVK can reduce delay to theater and maximize tariff payments in warfarinised patients with hip fracture. This is in addition to other established benefits associated with early surgery such as decreasing risk of pressure lesions and pneumonia. It affords high-quality patient-centered care while ensuring trauma units achieve maximal financial reimbursement through pay for improved performance and supports a culture of change behavior. PMID:26623160

Clinical and Radiographic Mid-Term Outcomes After Total Shoulder Replacement: A Retrospective Study Protocol Including 400 Anatomical and Reverse Prosthetic Implants

PubMed Central

Merolla, Giovanni; Tartarone, Antonio; Porcellini, Giuseppe

2016-01-01

Objectives: To obtain outcomes data on anatomical and reverse total shoulder arthroplasty by analysis of clinical scores and standard radiographs. Subject selection and enrollment: 400 consecutive series of patients replaced with anatomical and reverse total shoulder arthroplasty (minimum 3 years follow-up). Study Design: retrospective monocenter. Preoperative assessment: Demographics, clinical scores (Constant-Murley) as available, shoulder X-ray (AP, outlet and axillary views) . Last follow-up: Postoperative radiographhs and clinical scores. Adverse events and complications to be reported as occurred since implantation. Statistical analysis: Data collected will be summarized and analyzed for statistical significance. PMID:27326389

A virtual experimenter to increase standardization for the investigation of placebo effects.

PubMed

Horing, Bjoern; Newsome, Nathan D; Enck, Paul; Babu, Sabarish V; Muth, Eric R

2016-07-18

Placebo effects are mediated by expectancy, which is highly influenced by psychosocial factors of a treatment context. These factors are difficult to standardize. Furthermore, dedicated placebo research often necessitates single-blind deceptive designs where biases are easily introduced. We propose a study protocol employing a virtual experimenter - a computer program designed to deliver treatment and instructions - for the purpose of standardization and reduction of biases when investigating placebo effects. To evaluate the virtual experimenter's efficacy in inducing placebo effects via expectancy manipulation, we suggest a partially blinded, deceptive design with a baseline/retest pain protocol (hand immersions in hot water bath). Between immersions, participants will receive an (actually inert) medication. Instructions pertaining to the medication will be delivered by one of three metaphors: The virtual experimenter, a human experimenter, and an audio/text presentation (predictor "Metaphor"). The second predictor includes falsely informing participants that the medication is an effective pain killer, or correctly informing them that it is, in fact, inert (predictor "Instruction"). Analysis will be performed with hierarchical linear modelling, with a sample size of N = 50. Results from two pilot studies are presented that indicate the viability of the pain protocol (N = 33), and of the virtual experimenter software and placebo manipulation (N = 48). It will be challenging to establish full comparability between all metaphors used for instruction delivery, and to account for participant differences in acceptance of their virtual interaction partner. Once established, the presence of placebo effects would suggest that the virtual experimenter exhibits sufficient cues to be perceived as a social agent. He could consequently provide a convenient platform to investigate effects of experimenter behavior, or other experimenter characteristics, e.g., sex, age, race/ethnicity or professional status. More general applications are possible, for example in psychological research such as bias research, or virtual reality research. Potential applications also exist for standardizing clinical research by documenting and communicating instructions used in clinical trials.

A tonic heat test stimulus yields a larger and more reliable conditioned pain modulation effect compared to a phasic heat test stimulus

PubMed Central

Lie, Marie Udnesseter; Matre, Dagfinn; Hansson, Per; Stubhaug, Audun; Zwart, John-Anker; Nilsen, Kristian Bernhard

2017-01-01

Abstract Introduction: The interest in conditioned pain modulation (CPM) as a clinical tool for measuring endogenously induced analgesia is increasing. There is, however, large variation in the CPM methodology, hindering comparison of results across studies. Research comparing different CPM protocols is needed in order to obtain a standardized test paradigm. Objectives: The aim of the study was to assess whether a protocol with phasic heat stimuli as test-stimulus is preferable to a protocol with tonic heat stimulus as test-stimulus. Methods: In this experimental crossover study, we compared 2 CPM protocols with different test-stimulus; one with tonic test-stimulus (constant heat stimulus of 120-second duration) and one with phasic test-stimuli (3 heat stimulations of 5 seconds duration separated by 10 seconds). Conditioning stimulus was a 7°C water bath in parallel with the test-stimulus. Twenty-four healthy volunteers were assessed on 2 occasions with minimum 1 week apart. Differences in the magnitude and test–retest reliability of the CPM effect in the 2 protocols were investigated with repeated-measures analysis of variance and by relative and absolute reliability indices. Results: The protocol with tonic test-stimulus induced a significantly larger CPM effect compared to the protocol with phasic test-stimuli (P < 0.001). Fair and good relative reliability was found with the phasic and tonic test-stimuli, respectively. Absolute reliability indices showed large intraindividual variability from session to session in both protocols. Conclusion: The present study shows that a CPM protocol with a tonic test-stimulus is preferable to a protocol with phasic test-stimuli. However, we emphasize that one should be cautious to use the CPM effect as biomarker or in clinical decision making on an individual level due to large intraindividual variability. PMID:29392240

Comparative studies of mesenchymal stem cells derived from different cord tissue compartments - The influence of cryopreservation and growth media.

PubMed

Dulugiac, Magda; Moldovan, Lucia; Zarnescu, Otilia

2015-10-01

We have identified some critical aspects concerning umbilical cord tissue mesenchymal stem cells: the lack of standards for cell isolation, expansion and cryopreservation, the lack of unanimous opinions upon their multilineage differentiation potential and the existence of very few results related to the functional characterization of the cells isolated from cryopreserved umbilical cord tissue. Umbilical cord tissue cryopreservation appears to be the optimal solution for umbilical cord tissue mesenchymal stem cells storage for future clinical use. Umbilical cord tissue cryopreservation allows mesenchymal stem cells isolation before expected use, according with the specific clinical applications, by different customized isolation and expansion protocols agreed by cell therapy institutions. Using an optimized protocol for umbilical cord tissue cryopreservation in autologous cord blood plasma, isolation explant method and growth media supplemented with FBS or human serum, we performed comparative studies with respect to the characteristics of mesenchymal stem cells (MSC) isolated from different compartments of the same umbilical cord tissue such as Wharton's jelly, vein, arteries, before cryopreservation (pre freeze) and after cryopreservation (post thaw). Expression of histochemical and immunohistochemical markers as well as electron microscopy observations revealed similar adipogenic, chondrogenic and osteogenic differentiation capacity for cells isolated from pre freeze and corresponding post thaw tissue fragments of Wharton's jelly, vein or arteries of the same umbilical cord tissue, regardless growth media used for cells isolation and expansion. Our efficient umbilical cord tissue cryopreservation protocol is reliable for clinical applicability of mesenchymal stem cells that could next be isolated and expanded in compliance with future accepted standards. Copyright © 2015 Elsevier Ltd. All rights reserved.

Critical issues with the in vivo comet assay: A report of the comet assay working group in the 6th International Workshop on Genotoxicity Testing (IWGT).

PubMed

Speit, Günter; Kojima, Hajime; Burlinson, Brian; Collins, Andrew R; Kasper, Peter; Plappert-Helbig, Ulla; Uno, Yoshifumi; Vasquez, Marie; Beevers, Carol; De Boeck, Marlies; Escobar, Patricia A; Kitamoto, Sachiko; Pant, Kamala; Pfuhler, Stefan; Tanaka, Jin; Levy, Dan D

2015-05-01

As a part of the 6th IWGT, an expert working group on the comet assay evaluated critical topics related to the use of the in vivo comet assay in regulatory genotoxicity testing. The areas covered were: identification of the domain of applicability and regulatory acceptance, identification of critical parameters of the protocol and attempts to standardize the assay, experience with combination and integration with other in vivo studies, demonstration of laboratory proficiency, sensitivity and power of the protocol used, use of different tissues, freezing of samples, and choice of appropriate measures of cytotoxicity. The standard protocol detects various types of DNA lesions but it does not detect all types of DNA damage. Modifications of the standard protocol may be used to detect additional types of specific DNA damage (e.g., cross-links, bulky adducts, oxidized bases). In addition, the working group identified critical parameters that should be carefully controlled and described in detail in every published study protocol. In vivo comet assay results are more reliable if they were obtained in laboratories that have demonstrated proficiency. This includes demonstration of adequate response to vehicle controls and an adequate response to a positive control for each tissue being examined. There was a general agreement that freezing of samples is an option but more data are needed in order to establish generally accepted protocols. With regard to tissue toxicity, the working group concluded that cytotoxicity could be a confounder of comet results. It is recommended to look at multiple parameters such as histopathological observations, organ-specific clinical chemistry as well as indicators of tissue inflammation to decide whether compound-specific toxicity might influence the result. The expert working group concluded that the alkaline in vivo comet assay is a mature test for the evaluation of genotoxicity and can be recommended to regulatory agencies for use. Copyright © 2014 Elsevier B.V. All rights reserved.

Integrating DXplain into a clinical information system using the World Wide Web.

PubMed

Elhanan, G; Socratous, S A; Cimino, J J

1996-01-01

The World Wide Web(WWW) offers a cross-platform environment and standard protocols that enable integration of various applications available on the Internet. The authors use the Web to facilitate interaction between their Web-based Clinical Information System and a decision-support system-DXplain, at the Massachusetts General Hospital-using local architecture and Common Gateway Interface programs. The current application translates patients laboratory test results into DXplain's terms to generate diagnostic hypotheses. Two different access methods are utilized for this model; Hypertext Transfer Protocol (HTTP) and TCP/IP function calls. While clinical aspects cannot be evaluated as yet, the model demonstrates the potential of Web-based applications for interaction and integration and how local architecture, with a controlled vocabulary server, can further facilitate such integration. This model serves to demonstrate some of the limitations of the current WWW technology and identifies issues such as control over Web resources and their utilization and liability issues as possible obstacles for further integration.

Multisite Semiautomated Clinical Data Repository for Duplication 15q Syndrome: Study Protocol and Early Uses.

PubMed

Ajayi, Oluwaseun Jessica; Smith, Ebony Jeannae; Viangteeravat, Teeradache; Huang, Eunice Y; Nagisetty, Naga Satya V Rao; Urraca, Nora; Lusk, Laina; Finucane, Brenda; Arkilo, Dimitrios; Young, Jennifer; Jeste, Shafali; Thibert, Ronald; Reiter, Lawrence T

2017-10-18

Chromosome 15q11.2-q13.1 duplication syndrome (Dup15q syndrome) is a rare disorder caused by duplications of chromosome 15q11.2-q13.1, resulting in a wide range of developmental disabilities in affected individuals. The Dup15q Alliance is an organization that provides family support and promotes research to improve the quality of life of patients living with Dup15q syndrome. Because of the low prevalence of this condition, the establishment of a single research repository would have been difficult and more time consuming without collaboration across multiple institutions. The goal of this project is to establish a national deidentified database with clinical and survey information on individuals diagnosed with Dup15q syndrome. The development of a multiclinic site repository for clinical and survey data on individuals with Dup15q syndrome was initiated and supported by the Dup15q Alliance. Using collaborative workflows, communication protocols, and stakeholder engagement tools, a comprehensive database of patient-centered information was built. We successfully established a self-report populating, centralized repository for Dup15q syndrome research. This repository also resulted in the development of standardized instruments that can be used for other studies relating to developmental disorders. By standardizing the data collection instruments, it allows us integrate our data with other national databases, such as the National Database for Autism Research. A substantial portion of the data collected from the questionnaires was facilitated through direct engagement of participants and their families. This allowed for a more complete set of information to be collected with a minimal turnaround time. We developed a repository that can efficiently be mined for shared clinical phenotypes observed at multiple clinic sites and used as a springboard for future clinical and basic research studies. ©Oluwaseun Jessica Ajayi, Ebony Jeannae Smith, Teeradache Viangteeravat, Eunice Y Huang, Naga Satya V Rao Nagisetty, Nora Urraca, Laina Lusk, Brenda Finucane, Dimitrios Arkilo, Jennifer Young, Shafali Jeste, Ronald Thibert, The Dup15q Alliance, Lawrence T Reiter. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.10.2017.

Comparison of clinical and physics scoring of PET images when image reconstruction parameters are varied.

PubMed

Walsh, C; Johnston, C; Sheehy, N; O' Reilly, G

2013-02-01

In this study the quantitative and qualitative image quality (IQ) measurements with clinical judgement of IQ in positron emission tomography (PET) were compared. The limitations of IQ metrics and the proposed criteria of acceptability for PET scanners are discussed. Phantom and patient images were reconstructed using seven different iterative reconstruction protocols. For each reconstructed set of images, IQ was scored based both on the visual analysis and on the quantitative metrics. The quantitative physics metrics did not rank the reconstruction protocols in the same order as the clinicians' scoring of perceived IQ (R(s)=-0.54). Better agreement was achieved when comparing the clinical perception of IQ to the physicist's visual assessment of IQ in the phantom images (R(s)=+0.59). The closest agreement was seen between the quantitative physics metrics and the measurement of the standard uptake values (SUVs) in small tumours (R(s)=+0.92). Given the disparity between the clinical perception of IQ and the physics metrics a cautious approach to use of IQ measurements for determining suspension levels is warranted.

Evaluation of a Modified Pamidronate Protocol for the Treatment of Osteogenesis Imperfecta.

PubMed

Palomo, Telma; Andrade, Maria C; Peters, Barbara S E; Reis, Fernanda A; Carvalhaes, João Tomás A; Glorieux, Francis H; Rauch, Frank; Lazaretti-Castro, Marise

2016-01-01

Intravenous pamidronate is widely used to treat children with osteogenesis imperfecta (OI). In a well-studied protocol ('standard protocol'), pamidronate is given at a daily dose of 1 mg per kg body weight over 4 h on 3 successive days; infusion cycles are repeated every 4 months. Here, we evaluated renal safety of a simpler protocol for intravenous pamidronate infusions (2 mg per kg body weight given in a single infusion over 2 h, repeated every 4 months; 'modified protocol'). Results of 18 patients with OI types I, III, or IV treated with the modified protocol for 12 months were compared to 18 historic controls, treated with standard protocol. In the modified protocol, mild transient post-infusion increases in serum creatinine were found during each infusion but after 12 months serum creatinine remained similar from baseline [0.40 mg/dl (SD: 0.13)] to the end of the study [0.41 mg/dl (SD: 0.11)] (P = 0.79). The two protocols led to similar changes in serum creatinine during the first pamidronate infusion [modified protocol: +2% (SD: 21%); standard protocol: -3% (SD: 8%); P = 0.32]. Areal lumbar spine bone mineral density Z-scores increased from -2.7 (SD: 1.5) to -1.8 (SD: 1.4) with the modified protocol, and from -4.1 (SD: 1.4) to -3.1 (SD: 1.1) with standard protocol (P = 0.68 for group differences in bone density Z-score changes). The modified pamidronate protocol is safe and may have similar effects on bone density as the standard pamidronate protocol. More studies are needed with longer follow-up to prove anti-fracture efficacy.

Nutrition management in enhanced recovery after abdominal pancreatic surgery.

PubMed

Márquez Mesa, Elena; Baz Figueroa, Caleb; Suárez Llanos, José Pablo; Sanz Pereda, Pablo; Barrera Gómez, Manuel Ángel

Multimodal rehabilitation programs are perioperative standardized strategies with the objective of improving patient recovery, and decreasing morbidity, hospital stay and health cost. The nutritional aspect is an essential component of multimodal rehabilitation programs and therefore nutritional screening is recommended prior to hospital admission, avoiding pre-surgical fasting, with oral carbohydrate overload and early initiation of oral intake after surgery. However, there are no standardized protocols of diet progression after pancreatic surgery. A systematic review was been performed of papers published between 2006 and 2016, describing different nutritional strategies after pancreatic surgery and its possible implications in postoperative outcome. The studies evaluated are very heterogeneous, so conclusive results could not be drawn on the diet protocol to be implemented, its influence on clinical variables, or the need for concomitant artificial nutrition. Copyright © 2017 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Internet-based intervention programme for obese adolescents and their families (Next.Step): research protocol of a controlled trial.

PubMed

Sousa, Pedro; Fonseca, Helena; Gaspar, Pedro; Gaspar, Filomena

2014-04-01

This paper describes the design and rationale of a controlled trial that aims to determine the effectiveness of an intervention programme in which the internet is used. Adolescent obesity is a major health problem, there being urgency to find effective interventions that induce behavioural change. The inclusion of the internet in the intervention may improve adolescents' adherence to the weight management programme and lead to adoption of healthier lifestyles. A clinical trial with a control group (non-randomized). Participants are adolescents with appointments at a paediatric obesity clinic (Portugal). Sample size was calculated according to the power analysis. The experimental group will follow the standard treatment protocol and receive free access to the e-therapeutic platform. The control group will follow the standard treatment protocol and join a waiting list. Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up for 12 weeks). This study was approved by the Ethical Committee for Health (Lisbon, Portugal) in January 2012 and funded by the Foundation for Science and Technology (Portugal) in December 2012. The results of this research will promote reflection on new approaches directed to treat adolescent obesity and on the promotion of healthy behaviours. We expect to gather empirical evidence of the intervention programme effectiveness. The expectations lie on the population health gains, empowerment in decision-making and adoption of healthier lifestyles. © 2013 John Wiley & Sons Ltd.

Dual trigger of triptorelin and HCG optimizes clinical outcome for high ovarian responder in GnRH-antagonist protocols.

PubMed

Li, Saijiao; Zhou, Danni; Yin, Tailang; Xu, Wangming; Xie, Qingzhen; Cheng, Dan; Yang, Jing

2018-01-12

In this paper, a retrospective cohort study was conducted to the high ovarian responders in GnRH-antagonist protocols of IVF/ICSI cycles. The purpose of the study is to investigate whether dual triggering of final oocyte maturation with a combination of gonadotropin-releasing hormone (GnRH) agonist and human chorionic gonadotropin (HCG) can improve the clinical outcome compared with traditional dose (10000IU) HCG trigger and low-dose (8000IU) HCG trigger for high ovarian responders in GnRH-antagonist in vitro fertilization/intracytoplasmic sperm injection (IVF-ICSI) cycles. Our study included 226 couples with high ovarian responders in GnRH-antagonist protocols of IVF/ICSI cycles. Standard dosage of HCG trigger (10000 IU of recombinant HCG) versus dual trigger (0.2 mg of triptorelin and 2000 IU of recombinant HCG) and low-dose HCG trigger (8000IU of recombinant HCG) were used for final oocyte maturation. Our main outcome measures were high quality embryo rate, the number of usable embryos, the risk of OHSS, duration of hospitalization and incidence rate of complications. Our evidence demonstrated that dual trigger is capable of preventing severe OHSS while still maintaining excellent high quality embryo rate in in high ovarian responders of GnRH-antagonist protocols.

Validation of the Pangao PG-800B5 for clinical use and self-measurement according to the European Society of Hypertension International Protocol revision 2010.

PubMed

Chen, Wan; Zeng, Zhaolin; Li, Lizhi; Wan, Xiaofen; Wan, Yi

2014-10-01

This study aimed to validate the Pangao PG-800B5 upper arm blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010. A total of 33 participants, 16 men and 17 women, were included in the device evaluation. The protocol requirements were followed precisely. The mean age of the participants was 56.4±21.0 years (range 22-84 years). The mean systolic blood pressure was 143.6±25.5 mmHg (range 98-188 mmHg), the mean diastolic blood pressure was 85.7±17.2 mmHg (range 49-125 mmHg), and the mean arm circumference was 26.1±2.2 cm (range 23-32 cm). On average, the device overestimated the systolic blood pressure by 0.9±4.2 mmHg and diastolic blood pressure by 0.7±4.5 mmHg. The device passed all requirements, fulfilling the standards of the protocol. Therefore, the Pangao PG-800B5 upper arm blood pressure monitor can be recommended for clinical use and self-measurement in an adult population.

Validity Evidence and Scoring Guidelines for Standardized Patient Encounters and Patient Notes From a Multisite Study of Clinical Performance Examinations in Seven Medical Schools.

PubMed

Park, Yoon Soo; Hyderi, Abbas; Heine, Nancy; May, Win; Nevins, Andrew; Lee, Ming; Bordage, Georges; Yudkowsky, Rachel

2017-11-01

To examine validity evidence of local graduation competency examination scores from seven medical schools using shared cases and to provide rater training protocols and guidelines for scoring patient notes (PNs). Between May and August 2016, clinical cases were developed, shared, and administered across seven medical schools (990 students participated). Raters were calibrated using training protocols, and guidelines were developed collaboratively across sites to standardize scoring. Data included scores from standardized patient encounters for history taking, physical examination, and PNs. Descriptive statistics were used to examine scores from the different assessment components. Generalizability studies (G-studies) using variance components were conducted to estimate reliability for composite scores. Validity evidence was collected for response process (rater perception), internal structure (variance components, reliability), relations to other variables (interassessment correlations), and consequences (composite score). Student performance varied by case and task. In the PNs, justification of differential diagnosis was the most discriminating task. G-studies showed that schools accounted for less than 1% of total variance; however, for the PNs, there were differences in scores for varying cases and tasks across schools, indicating a school effect. Composite score reliability was maximized when the PN was weighted between 30% and 40%. Raters preferred using case-specific scoring guidelines with clear point-scoring systems. This multisite study presents validity evidence for PN scores based on scoring rubric and case-specific scoring guidelines that offer rigor and feedback for learners. Variability in PN scores across participating sites may signal different approaches to teaching clinical reasoning among medical schools.

The standard treatment protocol for paracetamol poisoning may be inadequate following overdose with modified release formulation: a pharmacokinetic and clinical analysis of 53 cases.

PubMed

Salmonson, Heléne; Sjöberg, Gunilla; Brogren, Jacob

2018-01-01

The use of the standard procedure for managing overdoses with immediate release (IR) paracetamol is questionable when applied to overdoses with modified release (MR) formulations. This study describes the pharmacokinetics of paracetamol and the clinical outcomes following overdoses with a MR formulation. Medical records including laboratory analyses concerning overdoses of MR paracetamol from 2009 to 2015 were collected retrospectively. Inclusion criteria were ingestion of a toxic dose, known time of intake and documented measurements of serum paracetamol and liver function tests. Graphical analysis, descriptive statistics and population pharmacokinetic modelling were used to describe data. Fifty-three cases were identified. Median age was 26 years (range 13-68), median dose was 20 g (range 10-166) and 74% were females. The pharmacokinetic analysis showed a complex, dose dependent serum versus time profile with prolonged absorption and delayed serum peak concentrations with increasing dose. Ten patients had persistently high serum levels for 24 h or more, six of them had a second peak 8-19 h after ingestion. Seven of 34 patients receiving N-acetylcysteine (NAC) within 8 h had alanine aminotransferase (ALT) above reference range. Three of them developed hepatotoxicity (ALT >1000 IU/l). The pharmacokinetic and clinical analysis showed that the standard treatment protocol, including risk assessment and NAC regimen, used for IR paracetamol poisoning not appear suitable for MR formulation. Individual and tailored treatment may be valuable but further studies are warranted to determine optimal regimen of overdoses with MR formulation.

Low-dose oral microemulsion ciclosporin for severe, refractory ulcerative colitis.

PubMed

de Saussure, P; Soravia, C; Morel, P; Hadengue, A

2005-08-01

The optimal modalities of treatment with oral microemulsion ciclosporin in patients with severe, steroid-refractory ulcerative colitis are uncertain. To assess the applicability, in terms of efficacy and tolerability, of a standard oral microemulsion ciclosporin treatment protocol targeting relatively low blood ciclosporin concentrations, in patients with severe, steroid-resistant ulcerative colitis. Patients with a severe attack of ulcerative colitis and no satisfactory response to intravenous corticosteroids were started on oral microemulsion ciclosporin. Dosages were adapted according to a standard protocol, targeting a blood predose ciclosporin concentration (C0) of 100-200 ng/mL. Patients without a clinical response on day 8 were scheduled for colectomy. Sixteen patients were enrolled. A clinical response was observed in 14/16 (88%). The mean clinical activity index scores and concentrations of C-reactive protein on days 0, 4 and 8 were 11.8, 6.7 and 4.1, and 50.3, 19.3 and 9.7 mg/L respectively. The mean C0 (days 0-8) was 149 pg/mL. The mean creatinine clearance rates on days 0 and 8 were 88 and 96 mL/min. One patient had an acute elevation of transaminases that resulted in discontinuing ciclosporin. Even when dosed for a target C0 of 100-200 ng/mL, oral microemulsion ciclosporin for severe, steroid-refractory ulcerative colitis achieves an efficacy similar to that attained with higher, potentially more toxic levels. The oral route should replace intravenous treatment in this clinical setting.

Development of Standardized Material Testing Protocols for Prosthetic Liners

PubMed Central

Cagle, John C.; Reinhall, Per G.; Hafner, Brian J.; Sanders, Joan E.

2017-01-01

A set of protocols was created to characterize prosthetic liners across six clinically relevant material properties. Properties included compressive elasticity, shear elasticity, tensile elasticity, volumetric elasticity, coefficient of friction (CoF), and thermal conductivity. Eighteen prosthetic liners representing the diverse range of commercial products were evaluated to create test procedures that maximized repeatability, minimized error, and provided clinically meaningful results. Shear and tensile elasticity test designs were augmented with finite element analysis (FEA) to optimize specimen geometries. Results showed that because of the wide range of available liner products, the compressive elasticity and tensile elasticity tests required two test maxima; samples were tested until they met either a strain-based or a stress-based maximum, whichever was reached first. The shear and tensile elasticity tests required that no cyclic conditioning be conducted because of limited endurance of the mounting adhesive with some liner materials. The coefficient of friction test was based on dynamic coefficient of friction, as it proved to be a more reliable measurement than static coefficient of friction. The volumetric elasticity test required that air be released beneath samples in the test chamber before testing. The thermal conductivity test best reflected the clinical environment when thermal grease was omitted and when liner samples were placed under pressure consistent with load bearing conditions. The developed procedures provide a standardized approach for evaluating liner products in the prosthetics industry. Test results can be used to improve clinical selection of liners for individual patients and guide development of new liner products. PMID:28233885

Randomized Controlled Trial Comparing Transepithelial Corneal Cross-linking Using Iontophoresis with the Dresden Protocol in Progressive Keratoconus.

PubMed

Lombardo, Marco; Giannini, Daniela; Lombardo, Giuseppe; Serrao, Sebastiano

2017-06-01

To compare clinical outcomes of transepithelial corneal cross-linking using iontophoresis (T-ionto CL) and standard corneal cross-linking (standard CL) for the treatment of progressive keratoconus 12 months after the operation. Prospective randomized controlled clinical trial. Thirty-four eyes of 25 participants with progressive keratoconus were randomized into T-ionto CL (22 eyes) or standard CL (12 eyes). T-ionto CL was performed using an iontophoresis device with dextran-free 0.1% riboflavin-5-phosphate solution with enhancers and by irradiating the cornea with a 10 mW/cm 2 ultraviolet A device for 9 minutes. Standard CL was performed according to the Dresden protocol. The primary outcome measure was stabilization of keratoconus after 12 months through analysis of maximum simulated keratometry readings (K max , diopters). Other outcome measures were corrected distance visual acuity (CDVA, logarithm of the minimum angle of resolution [logMAR]), manifest spherical equivalent refraction (D), central corneal thickness (CCT, micrometers) and endothelial cell density (ECD). Follow-up examinations were arranged at 3 and 7 days and 1, 3, 6, and 12 months. Twelve months after T-ionto CL and standard CL, K max on average flattened by -0.52±1.30 D (P = 0.06) and -0.82±1.20 D (P = 0.04), respectively. The mean change in CDVA was -0.10±0.12 logMAR (P = 0.003) and -0.03±0.06 logMAR (P = 0.10) after T-ionto CL and standard CL, respectively. The manifest spherical equivalent refraction changed on average by +0.71±1.44 D (P = 0.03) and +0.21±0.76 D (P = 0.38), respectively. The CCT and ECD measures did not change significantly in any group at 12 months. Significant differences in the outcome measures between treatments were found in the first week postoperatively. No complications occurred in the T-ionto CL group; 1 eye (8%) had sterile corneal infiltrates, which did not affect the final visual acuity, in the standard CL group. Significant visual and refractive improvements were found 12 months after T-ionto CL, though the average improvement in corneal topography readings was slightly lower than the Dresden protocol in the same period. Copyright © 2017 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

A Protocol for Diagnosis and Management of Aortic Atherosclerosis in Cardiac Surgery Patients

PubMed Central

Brandon Bravo Bruinsma, George J.; Van 't Hof, Arnoud W. J.; Grandjean, Jan G.; Nierich, Arno P.

2017-01-01

In patients undergoing cardiac surgery, use of perioperative screening for aortic atherosclerosis with modified TEE (A-View method) was associated with lower postoperative mortality, but not stroke, as compared to patients operated on without such screening. At the time of clinical implementation and validation, we did not yet standardize the indications for modified TEE and the changes in patient management in the presence of aortic atherosclerosis. Therefore, we designed a protocol, which combined the diagnosis of atherosclerosis of thoracic aorta and the subsequent considerations with respect to the intraoperative management and provides a systematic approach to reduce the risk of cerebral complications. PMID:28852575

DDN (Defense Data Network) Protocol Handbook. Volume 1. DoD Military Standard Protocols

DTIC Science & Technology

1985-12-01

official Military Standard communication protocols in use on the DDN are included, as are several ARPANET (Advanced Research Projects Agency Network... research protocols which are currently in use, and some protocols currently undergoing review. Tutorial information and auxiliary documents are also...compatible with DoD needs, by researchers wishing to improve the protocols, and by impleroentors of local area networks (LANs) wishing their

Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review

PubMed Central

Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

2015-01-01

Introduction In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, ‘domains’) are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, ‘what’) is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Methods and analysis Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. Ethics and dissemination No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. Trial registration number The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. PMID:26560061

Enhancement of multimodality texture-based prediction models via optimization of PET and MR image acquisition protocols: a proof of concept

NASA Astrophysics Data System (ADS)

Vallières, Martin; Laberge, Sébastien; Diamant, André; El Naqa, Issam

2017-11-01

Texture-based radiomic models constructed from medical images have the potential to support cancer treatment management via personalized assessment of tumour aggressiveness. While the identification of stable texture features under varying imaging settings is crucial for the translation of radiomics analysis into routine clinical practice, we hypothesize in this work that a complementary optimization of image acquisition parameters prior to texture feature extraction could enhance the predictive performance of texture-based radiomic models. As a proof of concept, we evaluated the possibility of enhancing a model constructed for the early prediction of lung metastases in soft-tissue sarcomas by optimizing PET and MR image acquisition protocols via computerized simulations of image acquisitions with varying parameters. Simulated PET images from 30 STS patients were acquired by varying the extent of axial data combined per slice (‘span’). Simulated T 1-weighted and T 2-weighted MR images were acquired by varying the repetition time and echo time in a spin-echo pulse sequence, respectively. We analyzed the impact of the variations of PET and MR image acquisition parameters on individual textures, and we investigated how these variations could enhance the global response and the predictive properties of a texture-based model. Our results suggest that it is feasible to identify an optimal set of image acquisition parameters to improve prediction performance. The model constructed with textures extracted from simulated images acquired with a standard clinical set of acquisition parameters reached an average AUC of 0.84 +/- 0.01 in bootstrap testing experiments. In comparison, the model performance significantly increased using an optimal set of image acquisition parameters (p = 0.04 ), with an average AUC of 0.89 +/- 0.01 . Ultimately, specific acquisition protocols optimized to generate superior radiomics measurements for a given clinical problem could be developed and standardized via dedicated computer simulations and thereafter validated using clinical scanners.

Consensus Recommendations of the Multiple Sclerosis Study Group and Portuguese Neuroradiological Society for the Use of the Magnetic Resonance Imaging in Multiple Sclerosis in Clinical Practice: Part 1.

PubMed

Abreu, Pedro; Pedrosa, Rui; Sá, Maria José; Cerqueira, João; Sousa, Lívia; Da Silva, Ana Martins; Pinheiro, Joaquim; De Sá, João; Batista, Sónia; Simões, Rita Moiron; Pereira, Daniela Jardim; Vilela, Pedro; Vale, José

2018-05-30

Magnetic resonance imaging is established as a recognizable tool in the diagnosis and monitoring of multiple sclerosis patients. In the present, among multiple sclerosis centers, there are different magnetic resonance imaging sequences and protocols used to study multiple sclerosis that may hamper the optimal use of magnetic resonance imaging in multiple sclerosis. In this context, the Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after a joint discussion, appointed a committee of experts to create recommendations adapted to the national reality on the use of magnetic resonance imaging in multiple sclerosis. The purpose of this document is to publish the first Portuguese consensus recommendations on the use of magnetic resonance imaging in multiple sclerosis in clinical practice. The Group of Studies of Multiple Sclerosis and the Portuguese Society of Neuroradiology, after discussion of the topic in national meetings and after a working group meeting held in Figueira da Foz on May 2017, have appointed a committee of experts that have developed by consensus several standard protocols on the use of magnetic resonance imaging in the diagnosis and follow-up of multiple sclerosis. The document obtained was based on the best scientific evidence and expert opinion. Subsequently, the majority of Portuguese multiple sclerosis consultants and departments of neuroradiology scrutinized and reviewed the consensus paper; comments and suggestions were considered. Technical magnetic resonance imaging protocols regarding diagnostic, monitoring and the recommended information to be included in the magnetic resonance imaging report will be published in a separate paper. We provide some practical guidelines to promote standardized strategies to be applied in the clinical practice setting of Portuguese healthcare professionals regarding the use of magnetic resonance imaging in multiple sclerosis. We hope that these first Portuguese magnetic resonance imaging guidelines, based in the best available clinical evidence and practices, will serve to optimize multiple sclerosis management and improve multiple sclerosis patient care across Portugal.

Current-reported outcome domains in studies of adults with a focus on the treatment of tinnitus: protocol for a systematic review.

PubMed

Hall, Deborah A; Szczepek, Agnieszka J; Kennedy, Veronica; Haider, Haúla

2015-11-11

In Europe alone, over 70 million people experience tinnitus. Despite its considerable socioeconomic relevance, progress in developing successful treatments has been limited. Clinical effectiveness is judged according to change in primary outcome measures, but because tinnitus is a subjective condition, the definition of outcomes is challenging and it remains unclear which distinct aspects of tinnitus (ie, 'domains') are most relevant for assessment. The development of a minimum outcome reporting standard would go a long way towards addressing these problems. In 2006, a consensus meeting recommended using 1 of 4 questionnaires for tinnitus severity as an outcome in clinical trials, in part because of availability in different language translations. Our initiative takes an approach motivated by clinimetrics, first by determining what to measure before seeking to determine how to measure it. Agreeing on the domains that contribute to tinnitus severity (ie, 'what') is the first step towards achieving a minimum outcome reporting standard for tinnitus that has been reached via a methodologically rigorous and transparent process. Deciding what should be the core set of outcomes requires a great deal of discussion and so lends itself well to international effort. This protocol lays out the first-step methodology in defining a Core Domain Set for clinical trials of tinnitus by establishing existing knowledge and practice with respect to which outcome domains have been measured and which instruments used in recent registered and published clinical trials. No ethical issues are foreseen. Findings will be reported at national and international ear, nose and throat (ENT) and audiology conferences and in a peer-reviewed journal, using PRISMA (Preferred Reporting Items for Systematic reviews and Meta-analysis) guidelines. The systematic review protocol is registered on PROSPERO (International Prospective Register of Systematic Reviews): CRD42015017525. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A Systematic Evaluation of Blood Serum and Plasma Pre-Analytics for Metabolomics Cohort Studies

PubMed Central

Jobard, Elodie; Trédan, Olivier; Postoly, Déborah; André, Fabrice; Martin, Anne-Laure; Elena-Herrmann, Bénédicte; Boyault, Sandrine

2016-01-01

The recent thriving development of biobanks and associated high-throughput phenotyping studies requires the elaboration of large-scale approaches for monitoring biological sample quality and compliance with standard protocols. We present a metabolomic investigation of human blood samples that delineates pitfalls and guidelines for the collection, storage and handling procedures for serum and plasma. A series of eight pre-processing technical parameters is systematically investigated along variable ranges commonly encountered across clinical studies. While metabolic fingerprints, as assessed by nuclear magnetic resonance, are not significantly affected by altered centrifugation parameters or delays between sample pre-processing (blood centrifugation) and storage, our metabolomic investigation highlights that both the delay and storage temperature between blood draw and centrifugation are the primary parameters impacting serum and plasma metabolic profiles. Storing the blood drawn at 4 °C is shown to be a reliable routine to confine variability associated with idle time prior to sample pre-processing. Based on their fine sensitivity to pre-analytical parameters and protocol variations, metabolic fingerprints could be exploited as valuable ways to determine compliance with standard procedures and quality assessment of blood samples within large multi-omic clinical and translational cohort studies. PMID:27929400

Developing laser-based therapy monitoring of early caries in pediatric dental settings

NASA Astrophysics Data System (ADS)

Zhou, Yaxuan; Jiang, Yang; Kim, Amy S.; Xu, Zheng; Berg, Joel H.; Seibel, Eric J.

2017-02-01

Optical imaging modalities and therapy monitoring protocols are required for the emergence of non-surgical interventions for treating infections in teeth to remineralize the enamel. Current standard of visual inspection, tactile probing and radiograph for caries detection is not highly sensitive, quantitative, and safe. Furthermore, the latter two are not viable options for interproximal caries. We present preliminary results of multimodal laser-based imaging and uorescence spectroscopy in a blinded clinical study comparing two topical therapies of early interproximal caries in children. With a spacer placed interproximally both at baseline and followup examinations, the 405-nm excited red porphyrin uorescence imaging with green auto uorescence is measured and compared to a 12-month follow-up. 405-nm laser-induced uorescence spectroscopy is also measured from the center of selected multimodal video imaging frames. These results of three subjects are analyzed both qualitatively by comparing spectra and quantitatively based on uorescence region segmentation, and then are compared to the standard of care(visual examination and radiograph interpretation). Furthermore, this study points out challenges associated with optically monitoring non-surgical dental interventions over long periods of time in clinical practice and also indicates future direction for improvement on the protocol.

Programmatic assessment of a university-based implant training program using patient-reported outcomes.

PubMed

Al-Sabbagh, Mohanad; Jenkins, Diane W; de Leeuw, Reny; Nihill, Patricia; Robinson, Fonda G; Thomas, Mark V

2014-11-01

The University of Kentucky College of Dentistry (UKCD) established an implant training program that provides training in the use of a single implant system, evidence-based diagnostic and treatment protocols (standardized work practices), and a total quality management system (Implant Quality Assurance Program). The aim of this study was to assess the programmatic effectiveness of the UKCD implant training program by reporting the success and survival of implants placed, using patient-reported outcomes and comparing them to previously established benchmarks. A total of 415 patients (963 implants) were interviewed, approximately 50 percent of all qualified patients. The implant survival rate was 97 percent, and 88 percent of the implants were considered successful (as determined by patient-centric criteria). These outcomes were consistent with the program's previously established benchmarks of 90 percent. These results suggest that work standardization (in the form of specific treatment protocols) and the use of a formal, incremental learning system can result in positive patient outcomes. Clinical outcomes should be monitored in academic dental settings as part of clinical process improvement, and these outcomes can provide a means of assessing the effectiveness of the training program.

Comparison of the effect of two endodontic irrigation protocols on the elimination of bacteria from root canal system: a prospective, randomized clinical trial.

PubMed

Beus, Christopher; Safavi, Kamran; Stratton, Jeffrey; Kaufman, Blythe

2012-11-01

The purpose of this prospective, randomized clinical study was to compare the results of a nonactivated single-irrigation protocol (NAI) that used only 1% NaOCl with a passive ultrasonic multi-irrigation protocol (PUI) that used 1% NaOCl, 17% ethylenediaminetetraacetic acid, and 2% chlorhexidine in rendering canals bacteria free. In addition, the effect of a second-visit instrumentation after intra-appointment calcium hydroxide (CaOH(2)) was also evaluated in bacterial elimination. Fifty patients were recruited with a posterior tooth requiring primary endodontic treatment of apical periodontitis. Standard nonsurgical endodontic therapy was performed on both groups in a 2-visit approach by using calcium hydroxide intracanal medicament. Teeth were randomly treated with the NAI or PUI protocols in the first visit after complete instrumentation. Bacterial cultures were obtained at 4 periods during treatment from the canals: (1) before instrumentation, (2) after irrigation protocol, (3) after CaOH(2) medication, and (4) before obturation. Statistical analysis was performed on data by using the Fisher exact test and multivariate analysis. NAI and PUI rendered canals 80% and 84% bacteria free, respectively, at the end of the first visit. After CaOH(2) medication the total sample (NAI + PUI) had increased to 87% bacteria free, and the second-visit instrumentation resulted in a total of 91% bacteria free. These differences were not significant (P > .05). There was no statistical difference between irrigation methods. Each protocol resulted in a high frequency of negative cultures. This high frequency of negative cultures obtained in 1 visit is most likely related to an increased volume and depth of irrigation compared with previously reported protocols. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

The Activity of Antimicrobial Surfaces Varies by Testing Protocol Utilized

PubMed Central

Campos, Matias D.; Zucchi, Paola C.; Phung, Ann; Leonard, Steven N.; Hirsch, Elizabeth B.

2016-01-01

Background Contaminated hospital surfaces are an important source of nosocomial infections. A major obstacle in marketing antimicrobial surfaces is a lack of efficacy data based on standardized testing protocols. Aim We compared the efficacy of multiple testing protocols against several “antimicrobial” film surfaces. Methods Four clinical isolates were used: one Escherichia coli, one Klebsiella pneumoniae, and two Staphylococcus aureus strains. Two industry methods (modified ISO 22196 and ASTM E2149), a “dried droplet”, and a “transfer” method were tested against two commercially available antimicrobial films, one film in development, an untreated control, and a positive (silver) control film. At 2 (only ISO) and 24 hours following inoculation, bacteria were collected from film surfaces and enumerated. Results Compared to untreated films in all protocols, there were no significant differences in recovery on either commercial brand at 2 or 24 hours after inoculation. The silver surface demonstrated significant microbicidal activity (mean loss 4.9 Log10 CFU/ml) in all methods and time points with the exception of 2 hours in the ISO protocol and the transfer method. Using our novel droplet method, no differences between placebo and active surfaces were detected. The surface in development demonstrated variable activity depending on method, organism, and time point. The ISO demonstrated minimal activity at 2 hours but significant activity at 24 hours (mean 4.5 Log10 CFU/ml difference versus placebo). The ASTEM protocol exhibited significant differences in recovery of staphylococci (mean 5 Log10 CFU/ml) but not Gram-negative isolates (10 fold decrease). Minimal activity was observed with this film in the transfer method. Conclusions Varying results between protocols suggested that efficacy of antimicrobial surfaces cannot be easily and reproducibly compared. Clinical use should be considered and further development of representative methods is needed. PMID:27494336

Ultralow dose dentomaxillofacial CT imaging and iterative reconstruction techniques: variability of Hounsfield units and contrast-to-noise ratio

PubMed Central

Bischel, Alexander; Stratis, Andreas; Kakar, Apoorv; Bosmans, Hilde; Jacobs, Reinhilde; Gassner, Eva-Maria; Puelacher, Wolfgang; Pauwels, Ruben

2016-01-01

Objective: The aim of this study was to evaluate whether application of ultralow dose protocols and iterative reconstruction technology (IRT) influence quantitative Hounsfield units (HUs) and contrast-to-noise ratio (CNR) in dentomaxillofacial CT imaging. Methods: A phantom with inserts of five types of materials was scanned using protocols for (a) a clinical reference for navigated surgery (CT dose index volume 36.58 mGy), (b) low-dose sinus imaging (18.28 mGy) and (c) four ultralow dose imaging (4.14, 2.63, 0.99 and 0.53 mGy). All images were reconstructed using: (i) filtered back projection (FBP); (ii) IRT: adaptive statistical iterative reconstruction-50 (ASIR-50), ASIR-100 and model-based iterative reconstruction (MBIR); and (iii) standard (std) and bone kernel. Mean HU, CNR and average HU error after recalibration were determined. Each combination of protocols was compared using Friedman analysis of variance, followed by Dunn's multiple comparison test. Results: Pearson's sample correlation coefficients were all >0.99. Ultralow dose protocols using FBP showed errors of up to 273 HU. Std kernels had less HU variability than bone kernels. MBIR reduced the error value for the lowest dose protocol to 138 HU and retained the highest relative CNR. ASIR could not demonstrate significant advantages over FBP. Conclusions: Considering a potential dose reduction as low as 1.5% of a std protocol, ultralow dose protocols and IRT should be further tested for clinical dentomaxillofacial CT imaging. Advances in knowledge: HU as a surrogate for bone density may vary significantly in CT ultralow dose imaging. However, use of std kernels and MBIR technology reduce HU error values and may retain the highest CNR. PMID:26859336

Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

PubMed

Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

2014-06-01

Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

The Application of Standards and Recommendations to Clinical Ethics Consultation in Practice: An Evaluation at German Hospitals.

PubMed

Schochow, Maximilian; Rubeis, Giovanni; Steger, Florian

2017-06-01

The executive board of the Academy for Ethics in Medicine (AEM) and two AEM working groups formulated standards and recommendations for clinical ethics consultation in 2010, 2011, and 2013. These guidelines comply with the international standards like those set by the American Society for Bioethics and Humanities. There is no empirical data available yet that could indicate whether these standards and recommendations have been implemented in German hospitals. This desideratum is addressed in the present study. We contacted 1.858 German hospitals between September 2013 and January 2014. A follow-up survey was conducted between October 2014 and January 2015. The data of the initial survey and the follow-up survey were merged and evaluated. The statements of the participants were compared with the standards and recommendations. The standards of the AEM concerning the tasks of clinical ethics consultation (including ethics consultation, ethics training and the establishment of policy guidelines) are employed by a majority of participants of the study. Almost all of these participants document their consultation activities by means of protocols or entries in the patient file. There are deviations from the recommendations of the AEM working groups regarding the drafting of statutes, activity reports, and financial support. The activities of clinical ethics consultation predominantly comply with the standards of the AEM and recommendations for the documentation. The recommendations for evaluation should be improved in practice. This applies particularly for activity reports in order to evaluate the activities. Internal evaluation could take place accordingly.

SU-F-I-36: In-Utero Dose Measurements Within Postmortem Subjects for Estimating Fetal Doses in Pregnant Patients Examined with Pulmonary Embolism, Trauma, and Appendicitis CT

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

Lipnharski, I; Quails, N; Carranza, C

Purpose: The imaging of pregnant patients is medically necessary in certain clinical situations. The purpose of this work was to directly measure uterine doses in a cadaver scanned with CT protocols commonly performed on pregnant patients in order to estimate fetal dose and assess potential risk. Method: One postmortem subject was scanned on a 320-slice CT scanner with standard pulmonary embolism, trauma, and appendicitis protocols. All protocols were performed with the scan parameters and ranges currently used in clinical practice. Exams were performed both with and without iterative reconstruction to highlight the dose savings potential. Optically stimulated luminescent dosimeters (OSLDs)more » were inserted into the uterus in order to approximate fetal doses. Results: In the pulmonary embolism CT protocol, the uterus is outside of the primary beam, and the dose to the uterus was under 1 mGy. In the trauma and appendicitis protocols, the uterus is in the primary beam, the fetal dose estimates were 30.5 mGy for the trauma protocol, and 20.6 mGy for the appendicitis protocol. Iterative reconstruction reduced fetal doses by 30%, with uterine doses at 21.3 for the trauma and 14.3 mGy for the appendicitis protocol. Conclusion: Fetal doses were under 1 mGy when exposed to scatter radiation, and under 50 mGy when exposed to primary radiation with the trauma and appendicitis protocols. Consistent with the National Council on Radiation Protection & Measurements (NCRP) and the International Commission on Radiological Protection (ICRP), these doses exhibit a negligible risk to the fetus, with only a small increased risk of cancer. Still, CT scans are not recommended during pregnancy unless the benefits of the exam clearly outweigh the potential risk. Furthermore, when possible, pregnant patients should be examined on CT scanners equipped with iterative reconstruction in order to keep patient doses as low as reasonable achievable.« less

Use of clinical guidelines in remote Australia: A realist evaluation.

PubMed

Reddy, Sandeep; Orpin, Victoria; Herring, Sally; Mackie-Schneider, Stephanie; Struber, Janet

2018-02-01

The aim of this evaluation was to assess the acceptability, accessibility, and compliance with the 2014 editions of the Remote Primary Health Care Manuals (RPHCM) in health care centres across remote areas of Northern and Central Australia. To undertake a comprehensive evaluation that considered context, the evaluation used a realist evaluation framework. The evaluation used a variety of methods including interviews and survey to develop and test a programme theory. Many remote health practitioners have adopted standardized, evidence-based practice because of the use of the RPHCM. The mechanisms that led to the use of the manuals include acceptance of the worth of the protocols to their clinical practice, reliance on manual content to guide their practice, the perception of credibility, the applicability of RPHCM content to the context, and a fear of the consequences of not using the RPHCMs. Some remote health practitioners are less inclined to use the RPHCM regularly because of a perception that the content is less suited to their needs and daily practice or it is hard to navigate or understand. The evaluation concluded that there is work to be done to widen the RPHCM user base, and organizations need to increase support for their staff to use the RPHCM protocols better. These measures are expected to enable standardized clinical practice in the remote context. © 2017 John Wiley & Sons, Ltd.

Recent Innovations in Collagen Corneal Cross-linking; a Mini Review.

PubMed

Vastardis, Iraklis; Pajic-Eggspuehler, Brigitte; Nichorlis, Charis; Mueller, Jörg; Pajic, Bojan

2017-01-01

The introduction of corneal cross-linking (CXL) with ultraviolet-A (UVA) and Riboflavin photosensitizer (Vit B 2 ) from Seiler et al. , revolutionized the treatment of Keratoconus and other corneal ectatic diseases. Today, the commonly known epithelium off Dresden protocol is in clinical use for the last 15 years with great success and regarded by many as the golden standard. With several studies demonstrating its simplicity, efficacy and safety this revolutionary method, paved the way for new therapies and strategies in the treatment of corneal ectatic diseases and changed our understanding in corneal biomechanics. Recent scientific and technological advances enabled the creation of various modifications of the initial CXL protocol and the formation of new ones. This work highlights the recent advances of CXL, such as the role of oxygen, higher fluence and shorter irradiation times as well as the various clinical applications and updates of this method.

Can a science-based definition of acupuncture improve clinical outcomes?

PubMed

Priebe, Ted; Stumpf, Steven H; Zalunardo, Rod

2017-05-01

Research on acupuncture has been muddled by attempts to bridge the ancient with the modern. Barriers to effectiveness research are reflected in recurring conflicts that include disagreement on use of the most basic terms, lack of standard intervention controls, and the absence of functional measures for assessing treatment effect. Acupuncture research has stalled at the "placebo barrier" wherein acupuncture is "no better than placebo." The most widely recognized comparative effectiveness research in acupuncture does not compare acupuncture treatment protocols within groups, thereby, mutating large scale effectiveness studies into large scale efficacy trials. Too often research in acupuncture attempts to tie outcomes to traditional belief systems thereby limiting usefulness of the research. The acupuncture research paradigm needs to focus more closely on a scientific definition of treatments and outcomes that compare protocols in terms of prevalent clinical issues such as relative effectiveness for treating pain.

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

Nielsen, Yousef W., E-mail: yujwni01@heh.regionh.d; Eiberg, Jonas P., E-mail: Eiberg@dadlnet.d; Logager, Vibeke B., E-mail: viloe@heh.regionh.d

The purpose of this study was to determine the diagnostic performance of 3T whole-body magnetic resonance angiography (WB-MRA) using a hybrid protocol in comparison with a standard protocol in patients with peripheral arterial disease (PAD). In 26 consecutive patients with PAD two different protocols were used for WB-MRA: a standard sequential protocol (n = 13) and a hybrid protocol (n = 13). WB-MRA was performed using a gradient echo sequence, body coil for signal reception, and gadoterate meglumine as contrast agent (0.3 mmol/kg body weight). Two blinded observers evaluated all WB-MRA examinations with regard to presence of stenoses, as wellmore » as diagnostic quality and degree of venous contamination in each of the four stations used in WB-MRA. Digital subtraction angiography served as the method of reference. Sensitivity for detecting significant arterial disease (luminal narrowing {>=} 50%) using standard-protocol WB-MRA for the two observers was 0.63 (95%CI: 0.51-0.73) and 0.66 (0.58-0.78). Specificities were 0.94 (0.91-0.97) and 0.96 (0.92-0.98), respectively. In the hybrid protocol WB-MRA sensitivities were 0.75 (0.64-0.84) and 0.70 (0.58-0.8), respectively. Specificities were 0.93 (0.88-0.96) and 0.95 (0.91-0.97). Interobserver agreement was good using both the standard and the hybrid protocol, with {kappa} = 0.62 (0.44-0.67) and {kappa} = 0.70 (0.59-0.79), respectively. WB-MRA quality scores were significantly higher in the lower leg using the hybrid protocol compared to standard protocol (p = 0.003 and p = 0.03, observers 1 and 2). Distal venous contamination scores were significantly lower with the hybrid protocol (p = 0.02 and p = 0.01, observers 1 and 2). In conclusion, hybrid-protocol WB-MRA shows a better diagnostic performance than standard protocol WB-MRA at 3 T in patients with PAD.« less

Immunosuppression for in vivo research: state-of-the-art protocols and experimental approaches

PubMed Central

Diehl, Rita; Ferrara, Fabienne; Müller, Claudia; Dreyer, Antje Y; McLeod, Damian D; Fricke, Stephan; Boltze, Johannes

2017-01-01

Almost every experimental treatment strategy using non-autologous cell, tissue or organ transplantation is tested in small and large animal models before clinical translation. Because these strategies require immunosuppression in most cases, immunosuppressive protocols are a key element in transplantation experiments. However, standard immunosuppressive protocols are often applied without detailed knowledge regarding their efficacy within the particular experimental setting and in the chosen model species. Optimization of such protocols is pertinent to the translation of experimental results to human patients and thus warrants further investigation. This review summarizes current knowledge regarding immunosuppressive drug classes as well as their dosages and application regimens with consideration of species-specific drug metabolization and side effects. It also summarizes contemporary knowledge of novel immunomodulatory strategies, such as the use of mesenchymal stem cells or antibodies. Thus, this review is intended to serve as a state-of-the-art compendium for researchers to refine applied experimental immunosuppression and immunomodulation strategies to enhance the predictive value of preclinical transplantation studies. PMID:27721455

PET/CT in giant cell arteritis: High 18F-FDG uptake in the temporal, occipital and vertebral arteries.

PubMed

Rehak, Z; Vasina, J; Ptacek, J; Kazda, T; Fojtik, Z; Nemec, P

18 F-FDG PET/CT imaging is useful in patients with fever of unknown origin and can detect giant cell arteritis in extracranial large arteries. However, it is usually assumed that temporal arteries cannot be visualized with a PET/CT scanner due to their small diameter. Three patients with clinical symptoms of temporal arteritis were examined using a standard whole body PET/CT protocol (skull base - mid thighs) followed by a head PET/CT scan using the brain protocol. High 18 F-FDG uptake in the aorta and some arterial branches were detected in all 3 patients with the whole body protocol. Using the brain protocol, head imaging led to detection of high 18 F-FDG uptake in temporal arteries as well as in their branches (3 patients), in occipital arteries (2 patients) and also in vertebral arteries (3 patients). Copyright © 2016 Elsevier España, S.L.U. y SEMNIM. All rights reserved.

Treatment algorithms and protocolized care.

PubMed

Morris, Alan H

2003-06-01

Excess information in complex ICU environments exceeds human decision-making limits and likely contributes to unnecessary variation in clinical care, increasing the likelihood of clinical errors. I reviewed recent critical care clinical trials searching for information about the impact of protocol use on clinically pertinent outcomes. Several recently published clinical trials illustrate the importance of distinguishing efficacy and effectiveness trials. One of these trials illustrates the danger of conducting effectiveness trials before the efficacy of an intervention is established. The trials also illustrate the importance of distinguishing guidelines and inadequately explicit protocols from adequately explicit protocols. Only adequately explicit protocols contain enough detail to lead different clinicians to the same decision when faced with the same clinical scenario. Differences between guidelines and protocols are important. Guidelines lack detail and provide general guidance that requires clinicians to fill in many gaps. Computerized or paper-based protocols are detailed and, when used for complex clinical ICU problems, can generate patient-specific, evidence-based therapy instructions that can be carried out by different clinicians with almost no interclinician variability. Individualization of patient therapy can be preserved by these protocols when they are driven by individual patient data. Explicit decision-support tools (eg, guidelines and protocols) have favorable effects on clinician and patient outcomes and can reduce the variation in clinical practice. Guidelines and protocols that aid ICU decision makers should be more widely distributed.

Standardizing the care of detox patients to achieve quality outcomes.

PubMed

Becker, Kathy; Semrow, Sue

2006-03-01

Providing appropriate treatment for detoxification patients is both challenging and difficult because alcohol abuse and dependence are largely underestimated in the acute hospital setting. Alcohol withdrawal syndrome is treated not only by addictionologists on chemical dependency units, but also by primary care physicians in acute inpatient settings. The need for consistent inpatient treatment through the use of identified protocols can help provide safe and effective care. The need for consistent, inpatient medical-surgical detoxification treatment in our organization became apparent with the staff's identification of patient care concerns. Using an organizational approach, a multidisciplinary team was created to standardize the care of detoxification patients, beginning with patient admission and ending with discharge and referral for outpatient management. Standardization would ensure consistent assessment and intervention, and improve communication among the clinical team members. A protocol was developed for both the emergency department and the inpatient units. The goals of the team were to decrease the adverse events related to detoxification, such as seizures and aggression, and provide a consistent method of treatment for staff to follow.

The clinical effectiveness of concise cognitive behavioral therapy with or without pharmacotherapy for depressive and anxiety disorders; a pragmatic randomized controlled equivalence trial in clinical practice.

PubMed

Meuldijk, D; Carlier, I V E; van Vliet, I M; van Veen, T; Wolterbeek, R; van Hemert, A M; Zitman, F G

2016-03-01

Depressive and anxiety disorders contribute to a high disease burden. This paper investigates whether concise formats of cognitive behavioral- and/or pharmacotherapy are equivalent with longer standard care in the treatment of depressive and/or anxiety disorders in secondary mental health care. A pragmatic randomized controlled equivalence trial was conducted at five Dutch outpatient Mental Healthcare Centers (MHCs) of the Regional Mental Health Provider (RMHP) 'Rivierduinen'. Patients (aged 18-65 years) with a mild to moderate anxiety and/or depressive disorder, were randomly allocated to concise or standard care. Data were collected at baseline, 3, 6 and 12 months by Routine Outcome Monitoring (ROM). Primary outcomes were the Brief Symptom Inventory (BSI) and the Web Screening Questionnaire (WSQ). We used Generalized Estimating Equations (GEE) to assess outcomes. Between March 2010 and December 2012, 182 patients, were enrolled (n=89 standard care; n=93 concise care). Both intention-to-treat and per-protocol analyses demonstrated equivalence of concise care and standard care at all time points. Severity of illness reduced, and both treatments improved patient's general health status and subdomains of quality of life. Moreover, in concise care, the beneficial effects started earlier. Concise care has the potential to be a feasible and promising alternative to longer standard secondary mental health care in the treatment of outpatients with a mild to moderate depressive and/or anxiety disorder. For future research, we recommend adhering more strictly to the concise treatment protocols to further explore the beneficial effects of the concise treatment. The study is registered in the Netherlands Trial Register, number NTR2590. Clinicaltrials.gov identifier: NCT01643642. Copyright © 2015 Elsevier Inc. All rights reserved.

[Contemplation on the application of big data in clinical medicine].

PubMed

Lian, Lei

2015-01-01

Medicine is another area where big data is being used. The link between clinical treatment and outcome is the key step when applying big data in medicine. In the era of big data, it is critical to collect complete outcome data. Patient follow-up, comprehensive integration of data resources, quality control and standardized data management are the predominant approaches to avoid missing data and data island. Therefore, establishment of systemic patients follow-up protocol and prospective data management strategy are the important aspects of big data in medicine.

The Johns Hopkins RTR Consortium: A Collaborative Approach to Advance Translational Science and Standardize Clinical Monitoring of Restorative Transplantation - Immunomodulation and Tolerance Induction after VCA using Biologic Agent (cTLA4-Ig) and Donor Bone Marrow Cells

DTIC Science & Technology

2014-10-01

group, Pig 22227, was due to a gastrointestinal bleed , related to either infectious gastroenteritis/colitis or stress ulcer formation. The third... upper extremity transplantation. Delays in progress and incomplete groups will be discussed in detail in Section 5 – Changes/Problems. Table 1...Implemented successfully first clinical protocol for upper extremity transplantation using donor bone marrow cell therapies and tacrolimus

The applicability of real-time PCR in the diagnostic of cutaneous leishmaniasis and parasite quantification for clinical management: Current status and perspectives.

PubMed

Moreira, Otacilio C; Yadon, Zaida E; Cupolillo, Elisa

2017-09-29

Cutaneous leishmaniasis (CL) is spread worldwide and is the most common manifestation of leishmaniasis. Diagnosis is performed by combining clinical and epidemiological features, and through the detection of Leishmania parasites (or DNA) in tissue specimens or trough parasite isolation in culture medium. Diagnosis of CL is challenging, reflecting the pleomorphic clinical manifestations of this disease. Skin lesions vary in severity, clinical appearance, and duration, and in some cases, they can be indistinguishable from lesions related to other diseases. Over the past few decades, PCR-based methods, including real-time PCR assays, have been developed for Leishmania detection, quantification and species identification, improving the molecular diagnosis of CL. This review provides an overview of many real-time PCR methods reported for the diagnostic evaluation of CL and some recommendations for the application of these methods for quantification purposes for clinical management and epidemiological studies. Furthermore, the use of real-time PCR for Leishmania species identification is also presented. The advantages of real-time PCR protocols are numerous, including increased sensitivity and specificity and simpler standardization of diagnostic procedures. However, despite the numerous assays described, there is still no consensus regarding the methods employed. Furthermore, the analytical and clinical validation of CL molecular diagnosis has not followed international guidelines so far. A consensus methodology comprising a DNA extraction protocol with an exogenous quality control and an internal reference to normalize parasite load is still needed. In addition, the analytical and clinical performance of any consensus methodology must be accurately assessed. This review shows that a standardization initiative is essential to guide researchers and clinical laboratories towards the achievement of a robust and reproducible methodology, which will permit further evaluation of parasite load as a surrogate marker of prognosis and monitoring of aetiological treatment, particularly in multi-centric observational studies and clinical trials. Copyright © 2017 Elsevier B.V. All rights reserved.

Pediatric and Adolescent Gynecology in Europe: Clinical Services, Standards of Care, and Training.

PubMed

Richmond, Anna; Priyanka, Sweta; Mahmood, Tahir; MacDougall, Jane; Wood, Paul

2016-06-01

To identify current clinical services and training available across Europe within pediatric and adolescent gynecology (PAG) and establish the extent to which PAG services meet current European Board and College of Obstetrics and Gynecology (EBCOG) standards. Quantitative and qualitative questionnaire. European countries that are members of the EBCOG and the European Association of Pediatric and Adolescent Gynecology. Thirty-six countries that were approached beginning in September 2013; data were obtained from 27 countries. Questionnaires with 28 stems were sent to clinical leaders in 36 European countries. National society, national standards, legislation for female genital mutilation, protocols for transition to adult services, human papilloma virus vaccination programs, sex and contraception education, safeguarding, clinical leads for PAG, delivery of PAG services, and training available for PAG. Of 36 countries, 27 responded. Seventy-seven percent had a national PAG society but only 44% had national standards in PAG. There was agreement that PAG cases should be multidisciplinary but not all have clinical networks in place to facilitate this. Human papilloma virus programs are available in some European countries and not all have legislation against female genital mutilation. A significant proportion of cases continue to be seen in adult gynecology clinics as opposed to designated PAG clinics with only 41% with processes to transfer patients into adult care. In this article we provide a framework to explore areas for improvement within PAG services and training across Europe. The EBCOG standards of care are not being adhered to in many countries because processes and clinical networks are not in place to facilitate them. Crown Copyright © 2015. Published by Elsevier Inc. All rights reserved.

The Interlibrary Loan Protocol: An OSI Solution to ILL Messaging.

ERIC Educational Resources Information Center

Turner, Fay

1990-01-01

Discusses the interlibrary loan (ILL) protocol, a standard based on the principles of the Open Systems Interconnection (OSI) Reference Model. Benefits derived from protocol use are described, the status of the protocol as an international standard is reviewed, and steps taken by the National Library of Canada to facilitate migration to an ILL…

Manual muscle testing: a method of measuring extremity muscle strength applied to critically ill patients.

PubMed

Ciesla, Nancy; Dinglas, Victor; Fan, Eddy; Kho, Michelle; Kuramoto, Jill; Needham, Dale

2011-04-12

Survivors of acute respiratory distress syndrome (ARDS) and other causes of critical illness often have generalized weakness, reduced exercise tolerance, and persistent nerve and muscle impairments after hospital discharge. Using an explicit protocol with a structured approach to training and quality assurance of research staff, manual muscle testing (MMT) is a highly reliable method for assessing strength, using a standardized clinical examination, for patients following ARDS, and can be completed with mechanically ventilated patients who can tolerate sitting upright in bed and are able to follow two-step commands. (7, 8) This video demonstrates a protocol for MMT, which has been taught to ≥ 43 research staff who have performed >800 assessments on >280 ARDS survivors. Modifications for the bedridden patient are included. Each muscle is tested with specific techniques for positioning, stabilization, resistance, and palpation for each score of the 6-point ordinal Medical Research Council scale. Three upper and three lower extremity muscles are graded in this protocol: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and ankle dorsiflexion. These muscles were chosen based on the standard approach for evaluating patients for ICU-acquired weakness used in prior publications. (1,2).

Advancement of the Artificial Pancreas through the Development of Interoperability Standards

PubMed Central

Picton, Peter E.; Yeung, Melanie; Hamming, Nathaniel; Desborough, Lane; Dassau, Eyal; Cafazzo, Joseph A.

2013-01-01

Despite advancements in the development of the artificial pancreas, barriers in the form of proprietary data and communication protocols of diabetes devices have made the integration of these components challenging. The Artificial Pancreas Standards and Technical Platform Project is an initiative funded by the JDRF Canadian Clinical Trial Network with the goal of developing device communication standards for the interoperability of diabetes devices. Stakeholders from academia, industry, regulatory agencies, and medical and patient communities have been engaged in advancing this effort. In this article, we describe this initiative along with the process involved in working with the standards organizations and stakeholders that are key to ensuring effective standards are developed and adopted. Discussion from a special session of the 12th Annual Diabetes Technology Meeting is also provided. PMID:23911190

391 Description of Drug Allergy Study Conducted in a Teaching Hospital between October 2007 and March 2011

PubMed Central

Rodríguez Martínez, Consuelo Fernanda; Rubio, Alicia Sciaraffia

2012-01-01

Background The World Allergy Organization (WAO) in 2003 defined ‘drug allergy’ as an immunologically mediated drug hypersensitivity reaction. The mechanism of drug allergy may be either IgE or non-IgE mediated. The true incidence of drug allergy is not known. There are only few studies/datasets using standardized clinical questionnaires and validated in vivo or in vitro tests to confirm the diagnosis of drug allergy. Here we have analyzed the obtained results of in vivo test in suspected drug allergy patients. Methods Data from the Centre of Allergies of the Clinical Hospital of the Universidad de Chile between the months of October 2007 and March 2011 was obtained. The information of the protocols of drug executed, by defining as Protocol the study of a probable allergy by 2 or more procedures, which can be: Prick Test, intradermal reaction, specific IgE and/or Test Patch. Results For a total of 126 drug protocols, 25% of them were trivírica vaccine, 24% β-lactams, 21% local anaesthetics and 10% to general anesthesia (inductors, muscle relaxants and Latex). Of the total of patients undergoing protocols the most of them were women, there is no clear difference between the number of children and adults. The temporal distribution of protocols was stable between the months of October 2007 and March 2009 (15 protocols/semester), to then become variable, reaching values between 10 and 29 every 6 months. Of total protocols, 30.1% were positive; only one patient presented a mild adverse reaction (local welt). The β-lactams being most often the positive drugs. Protocols involving pethidine 100% was positive, diclofenac 33%, dipyrone, ketoprofen and hydrocortisone each one 25%. The most accomplished protocol was trivírica vaccine, resulting in 100% negative. Of all negative protocols 58% went to provocation, resulting in a 8% positive, including one provocation to the trívirica vaccine. Conclusions Methodologicall study is very important for a possible drug allergy, because history is not enough to certify the diagnosis. To do a provocation test to a negative protocol is crucial.

[Study protocol of a prevention of recurrent suicidal behaviour program based on case management (PSyMAC)].

PubMed

Sáiz, Pilar A; Rodríguez-Revuelta, Julia; González-Blanco, Leticia; Burón, Patricia; Al-Halabí, Susana; Garrido, Marlen; García-Alvarez, Leticia; García-Portilla, Paz; Bobes, Julio

2014-01-01

Prevention of suicidal behaviour is a public health priority in the European Union. A previous suicide attempt is the best risk predictor for future attempts, as well as completed suicides. The primary aim of this article is to describe a controlled study protocol designed for prevention of recurrent suicidal behaviour that proposes case management, and includes a psychoeducation program, as compared with the standard intervention (PSyMAC). Patients admitted from January 2011 to June 2013 to the emergency room of the Hospital Universitario Central de Asturias were evaluated using a protocol including sociodemographic, psychiatric, and psychosocial assessment. Patients were randomly assigned to either a group receiving continuous case management including participation in a psychoeducation program (experimental group), or a control group receiving standard care. The primary objective is to examine whether or not the period of time until recurrent suicidal behaviour in the experimental group is significantly different from that of the control group. PSyMAC proposes low cost and easily adaptable interventions to the usual clinical setting that can help to compensate the shortcoming of specific action protocols and suicidal behaviour prevention programs in our country. The evaluation of PSyMAC results will determine their real effectivity as a case-magament program to reduce suicidal risk. Copyright © 2013 SEP y SEPB. Published by Elsevier España. All rights reserved.

Reducing the Indication for Ventilatory Support in the Severely Burned Patient: Results of a New Protocol Approach at a Regional Burn Center.

PubMed

Gille, Jochen; Bauer, Nicole; Malcharek, Michael J; Dragu, Adrian; Sablotzki, Armin; Taha, Hischam; Czeslick, Elke

2016-01-01

Initial management of the severely injured routinely includes sedation and mechanical ventilatory support. However, nonjudiciously applied mechanical ventilatory support can itself lead to poorer patient outcomes. In an attempt to reduce this iatrogenic risk, a standardized, in-house, five-point protocol providing clinical guidance on the use and duration of ventilation was introduced and analyzed, and the impact on patient outcomes was assessed. In 2007, a protocol for early spontaneous breathing was introduced and established in clinical practice. This protocol included: 1) early extubation (≤6 hours after admission) in the absence of absolute ventilatory indication; 2) avoidance of "routine intubation" in spontaneously breathing patients; 3) early postoperative extubation, including patients requiring multiple surgical interventions; 4) intensive chest and respiratory physiotherapy with routine application of expectorants; and 5) early active mobilization. A retrospective clinical study compared patients (group A) over a 2-year period admitted under the new protocol with a historical patient group (group B). Patients in group A (n = 38) had fewer ventilator days over the time-course of treatment (3 [1; 5.8] vs 18.5 days [0.5; 20.5]; P = .0001) with a lower rate of tracheostomies (15.8 vs 54%; P = .0003). Patients on ventilation at admission in group A had shorter ventilation periods after admission (4.75 [4; 22.25] vs 378 hours [8.5; 681.5]; P = .0003), and 66.7% of these patients were extubated within 6 hours of admission (vs 9.1% in group B). No patients fulfilling the inclusion criteria required re- or emergency intubation. In the first 5 days of treatment, significantly lower Sequential Organ Failure Assessment scores were recorded in group A. There was also a trend for lower mortality rates (0 [0%] vs 6 [14%]), sepsis rates (24 [63.2%] vs 37 [88.1%]), and cumulative fluid balance on days 3 and 7 in group A. In contrast, group A demonstrated an elevated rate of pneumonia (15 [39.5%] vs 8 [19%]). These trends, however, lacked statistical significance. Our five-point protocol was safe and easily translated into clinical practice. In the authors experience, this protocol significantly reduced the ventilatory period in severely injured. Furthermore, this study suggests that many injured may be over-treated with routine ventilation, which carries accompanying risks.

An approach to standardization of urine sediment analysis via suggestion of a common manual protocol.

PubMed

Ko, Dae-Hyun; Ji, Misuk; Kim, Sollip; Cho, Eun-Jung; Lee, Woochang; Yun, Yeo-Min; Chun, Sail; Min, Won-Ki

2016-01-01

The results of urine sediment analysis have been reported semiquantitatively. However, as recent guidelines recommend quantitative reporting of urine sediment, and with the development of automated urine sediment analyzers, there is an increasing need for quantitative analysis of urine sediment. Here, we developed a protocol for urine sediment analysis and quantified the results. Based on questionnaires, various reports, guidelines, and experimental results, we developed a protocol for urine sediment analysis. The results of this new protocol were compared with those obtained with a standardized chamber and an automated sediment analyzer. Reference intervals were also estimated using new protocol. We developed a protocol with centrifugation at 400 g for 5 min, with the average concentration factor of 30. The correlation between quantitative results of urine sediment analysis, the standardized chamber, and the automated sediment analyzer were generally good. The conversion factor derived from the new protocol showed a better fit with the results of manual count than the default conversion factor in the automated sediment analyzer. We developed a protocol for manual urine sediment analysis to quantitatively report the results. This protocol may provide a mean for standardization of urine sediment analysis.

Nutritional adequacy of a novel human milk fortifier from donkey milk in feeding preterm infants: study protocol of a randomized controlled clinical trial.

PubMed

Coscia, Alessandra; Bertino, Enrico; Tonetto, Paola; Peila, Chiara; Cresi, Francesco; Arslanoglu, Sertac; Moro, Guido E; Spada, Elena; Milani, Silvano; Giribaldi, Marzia; Antoniazzi, Sara; Conti, Amedeo; Cavallarin, Laura

2018-01-09

Fortification of human milk is a standard practice for feeding very low birth weight infants. However, preterm infants often still experience suboptimal growth and feeding intolerance. New fortification strategies and different commercially available fortifiers have been developed. Commercially available fortifiers are constituted by a blend of ingredients from different sources, including plant oils and bovine milk proteins, thus presenting remarkable differences in the quality of macronutrients with respect to human milk. Based on the consideration that donkey milk has been suggested as a valid alternative for children allergic to cow's milk proteins, due to its biochemical similarity to human milk, we hypothesized that donkey milk could be a suitable ingredient for developing an innovative human milk fortifier. The aim of the study is to evaluate feeding tolerance, growth and clinical short and long-term outcomes in a population of preterm infants fed with a novel multi-component fortifier and a protein concentrate derived from donkey milk, in comparison to an analogous population fed with traditional fortifier and protein supplement containing bovine milk proteins. The study has been designed as a randomized, controlled, single-blind clinical trial. Infants born <1500 g and <32 weeks of gestational age were randomized to receive for 21 days either a combination of control bovine milk-based multicomponent fortifier and protein supplement, or a combination of a novel multicomponent fortifier and protein supplement derived from donkey milk. The fortification protocol followed is the same for the two groups, and the two diets were designed to be isoproteic and isocaloric. Weight, length and head circumference are measured; feeding tolerance is assessed by a standardized protocol. The occurrence of sepsis, necrotizing enterocolitis and adverse effects are monitored. This is the first clinical study investigating the use of a human milk fortifier derived from donkey milk for the nutrition of preterm infants. If donkey milk derived products will be shown to improve the feeding tolerance or either of the clinical, metabolic, neurological or auxological outcomes of preterm infants, it would be an absolute innovation in the field of feeding practices for preterm infants. ISRCTN - ISRCTN70022881 .

Considerations in establishing a post-mortem brain and tissue bank for the study of myalgic encephalomyelitis/chronic fatigue syndrome: a proposed protocol.

PubMed

Nacul, Luis; O'Donovan, Dominic G; Lacerda, Eliana M; Gveric, Djordje; Goldring, Kirstin; Hall, Alison; Bowman, Erinna; Pheby, Derek

2014-06-18

Our aim, having previously investigated through a qualitative study involving extensive discussions with experts and patients the issues involved in establishing and maintaining a disease specific brain and tissue bank for myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS), was to develop a protocol for a UK ME/CFS repository of high quality human tissue from well characterised subjects with ME/CFS and controls suitable for a broad range of research applications. This would involve a specific donor program coupled with rapid tissue collection and processing, supplemented by comprehensive prospectively collected clinical, laboratory and self-assessment data from cases and controls. We reviewed the operations of existing tissue banks from published literature and from their internal protocols and standard operating procedures (SOPs). On this basis, we developed the protocol presented here, which was designed to meet high technical and ethical standards and legal requirements and was based on recommendations of the MRC UK Brain Banks Network. The facility would be most efficient and cost-effective if incorporated into an existing tissue bank. Tissue collection would be rapid and follow robust protocols to ensure preservation sufficient for a wide range of research uses. A central tissue bank would have resources both for wide-scale donor recruitment and rapid response to donor death for prompt harvesting and processing of tissue. An ME/CFS brain and tissue bank could be established using this protocol. Success would depend on careful consideration of logistic, technical, legal and ethical issues, continuous consultation with patients and the donor population, and a sustainable model of funding ideally involving research councils, health services, and patient charities. This initiative could revolutionise the understanding of this still poorly-understood disease and enhance development of diagnostic biomarkers and treatments.

Rapid Diagnosis of Tuberculosis by Real-Time High-Resolution Imaging of Mycobacterium tuberculosis Colonies.

PubMed

Ghodbane, Ramzi; Asmar, Shady; Betzner, Marlena; Linet, Marie; Pierquin, Joseph; Raoult, Didier; Drancourt, Michel

2015-08-01

Culture remains the cornerstone of diagnosis for pulmonary tuberculosis, but the fastidiousness of Mycobacterium tuberculosis may delay culture-based diagnosis for weeks. We evaluated the performance of real-time high-resolution imaging for the rapid detection of M. tuberculosis colonies growing on a solid medium. A total of 50 clinical specimens, including 42 sputum specimens, 4 stool specimens, 2 bronchoalveolar lavage fluid specimens, and 2 bronchial aspirate fluid specimens were prospectively inoculated into (i) a commercially available Middlebrook broth and evaluated for mycobacterial growth indirectly detected by measuring oxygen consumption (standard protocol) and (ii) a home-made solid medium incubated in an incubator featuring real-time high-resolution imaging of colonies (real-time protocol). Isolates were identified by Ziehl-Neelsen staining and matrix-assisted laser desorption ionization-time of flight mass spectrometry. Use of the standard protocol yielded 14/50 (28%) M. tuberculosis isolates, which is not significantly different from the 13/50 (26%) M. tuberculosis isolates found using the real-time protocol (P = 1.00 by Fisher's exact test), and the contamination rate of 1/50 (2%) was not significantly different from the contamination rate of 2/50 (4%) using the real-time protocol (P = 1.00). The real-time imaging protocol showed a 4.4-fold reduction in time to detection, 82 ± 54 h versus 360 ± 142 h (P < 0.05). These preliminary data give the proof of concept that real-time high-resolution imaging of M. tuberculosis colonies is a new technology that shortens the time to growth detection and the laboratory diagnosis of pulmonary tuberculosis. Copyright © 2015, American Society for Microbiology. All Rights Reserved.

Validity of Assessments of Youth Access to Tobacco: The Familiarity Effect

PubMed Central

Landrine, Hope; Klonoff, Elizabeth A.

2003-01-01

Objectives. We examined the standard compliance protocol and its validity as a measure of youth access to tobacco. Methods. In Study 1, youth smokers reported buying cigarettes in stores where they are regular customers. In Study 2, youths attempted to purchase cigarettes by using the Standard Protocol, in which they appeared at stores once for cigarettes, and by using the Familiarity Protocol, in which they were rendered regular customers by purchasing nontobacco items 4 times and then requested cigarettes during their fifth visit. Results. Sales to youths aged 17 years in the Familiarity Protocol were significantly higher than sales to the same age group in the Standard Protocols (62.5% vs. 6%, respectively). Conclusions. The Standard Protocol does not match how youths obtain cigarettes. Access is low for stranger youths within compliance studies, but access is high for familiar youths outside of compliance studies. PMID:14600057

Use of Flowchart for Automation of Clinical Protocols in mHealth.

PubMed

Dias, Karine Nóra; Welfer, Daniel; Cordeiro d'Ornellas, Marcos; Pereira Haygert, Carlos Jesus; Dotto, Gustavo Nogara

2017-01-01

For healthcare professionals to use mobile applications we need someone who knows software development, provide them. In healthcare institutions, health professionals use clinical protocols to govern care, and sometimes these documents are computerized through mobile applications to assist them. This work aims to present a proposal of an application of flow as a way of describing clinical protocols for automatic generation of mobile applications to assist health professionals. The purpose of this research is to enable health professionals to develop applications from the description of their own clinical protocols. As a result, we developed a web system that automates clinical protocols for an Android platform, and we validated with two clinical protocols used in a Brazilian hospital. Preliminary results of the developed architecture demonstrate the feasibility of this study.

Comparison of the Liaison® Calprotectin kit with a well established point of care test (Quantum Blue - Bühlmann-Alere®) in terms of analytical performances and ability to detect relapses amongst a Crohn population in follow-up.

PubMed

Delefortrie, Quentin; Schatt, Patricia; Grimmelprez, Alexandre; Gohy, Patrick; Deltour, Didier; Collard, Geneviève; Vankerkhoven, Patrick

2016-02-01

Although colonoscopy associated with histopathological sampling remains the gold standard in the diagnostic and follow-up of inflammatory bowel disease (IBD), calprotectin is becoming an essential biomarker in gastroenterology. The aim of this work is to compare a newly developed kit (Liaison® Calprotectin - Diasorin®) and its two distinct extraction protocols (weighing and extraction device protocol) with a well established point of care test (Quantum Blue® - Bühlmann-Alere®) in terms of analytical performances and ability to detect relapses amongst a Crohn's population in follow-up. Stool specimens were collected over a six month period and were composed of control and Crohn's patients. Amongst the Crohn's population disease activity (active vs quiescent) was evaluated by gastroenterologists. A significant difference was found between all three procedures in terms of calprotectin measurements (weighing protocol=30.3μg/g (median); stool extraction device protocol=36.9μg/g (median); Quantum Blue® (median)=63; Friedman test, P value=0.05). However, a good correlation was found between both extraction methods coupled with the Liaison® analyzer and between the Quantum Blue® (weighing protocol/extraction device protocol Rs=0.844, P=0.01; Quantum Blue®/extraction device protocol Rs=0.708, P=0.01; Quantum Blue®/weighing protocol, Rs=0.808, P=0.01). Finally, optimal cut-offs (and associated negative predictive values - NPV) for detecting relapses were in accordance with above results (Quantum Blue® 183.5μg/g and NPV of 100%>extraction device protocol+Liaison® analyzer 124.5μg/g and NPV of 93.5%>weighing protocol+Liaison® analyzer 106.5μg/g and NPV of 95%). Although all three methods correlated well and had relatively good NPV in terms of detecting relapses amongst a Crohn's population in follow-up, the lack of any international standard is the origin of different optimal cut-offs between the three procedures. Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.

The Clinical Ethnographic Interview: A user-friendly guide to the cultural formulation of distress and help seeking

PubMed Central

Arnault, Denise Saint; Shimabukuro, Shizuka

2013-01-01

Transcultural nursing, psychiatry, and medical anthropology have theorized that practitioners and researchers need more flexible instruments to gather culturally relevant illness experience, meaning, and help seeking. The state of the science is sufficiently developed to allow standardized yet ethnographically sound protocols for assessment. However, vigorous calls for culturally adapted assessment models have yielded little real change in routine practice. This paper describes the conversion of the Diagnostic and Statistical Manual IV, Appendix I Outline for Cultural Formulation into a user-friendly Clinical Ethnographic Interview (CEI), and provides clinical examples of its use in a sample of highly distressed Japanese women. PMID:22194348

Impact of a lung transplantation donor-management protocol on lung donation and recipient outcomes.

PubMed

Angel, Luis F; Levine, Deborah J; Restrepo, Marcos I; Johnson, Scott; Sako, Edward; Carpenter, Andrea; Calhoon, John; Cornell, John E; Adams, Sandra G; Chisholm, Gary B; Nespral, Joe; Roberson, Ann; Levine, Stephanie M

2006-09-15

One of the limitations associated with lung transplantation is the lack of available organs. To determine whether a lung donor-management protocol could increase the number of lungs for transplantation without affecting the survival rates of the recipients. We implemented the San Antonio Lung Transplant protocol for managing potential lung donors according to modifications of standard criteria for donor selection and strategies for donor management. We then compared information gathered during a 4-yr period, during which the protocol was used with information gathered during a 4-yr period before protocol implementation. Primary outcome measures were the procurement rate of lungs and the 30-d and 1-yr survival rates of recipients. We reviewed data from 711 potential lung donors. The mean rate of lung procurement was significantly higher (p < 0.0001) during the protocol period (25.5%) than during the pre-protocol period (11.5%), with an estimated risk ratio of 2.2 in favor of the protocol period. More patients received transplants during the protocol period (n = 121) than during the pre-protocol period (n = 53; p < 0.0001). Of 98 actual lung donors during the protocol period, 53 (54%) had initially been considered poor donors; these donors provided 64 (53%) of the 121 lung transplants. The type of donor was not associated with significant differences in recipients' 30-d and 1-yr survival rates or any clinical measures of adequate graft function. The protocol was associated with a significant increase in the number of lung donors and transplant procedures without compromising pulmonary function, length of stay, or survival of the recipients.

Positioning Vascularized Composite Allotransplantation within the Spectrum of Transplantation

DTIC Science & Technology

2015-10-01

1 AWARD NUMBER: W81XWH-13-2-0057 TITLE: Positioning Vascularized Composite Allotransplantation within the Spectrum of Transplantation...Positioning Vascularized Composite Allotransplantation within the Spectrum of Transplantation 5b. GRANT NUMBER W81XWH-13-2-0057 5c. PROGRAM ELEMENT...Finally in Aim 8 we will develop standardization of protocols and clinical monitoring and treatment for VCA targeting vascular health. hand and face

Outcomes of Optimized over Standard Protocol of Rabbit Antithymocyte Globulin for Severe Aplastic Anemia: A Single-Center Experience

PubMed Central

Ge, Meili; Shao, Yingqi; Huang, Jinbo; Huang, Zhendong; Zhang, Jing; Nie, Neng; Zheng, Yizhou

2013-01-01

Background Previous reports showed that outcome of rabbit antithymocyte globulin (rATG) was not satisfactory as the first-line therapy for severe aplastic anemia (SAA). We explored a modifying schedule of administration of rATG. Design and Methods Outcomes of a cohort of 175 SAA patients, including 51 patients administered with standard protocol (3.55 mg/kg/d for 5 days) and 124 cases with optimized protocol (1.97 mg/kg/d for 9 days) of rATG plus cyclosporine (CSA), were analyzed retrospectively. Results Of all 175 patients, response rates at 3 and 6 months were 36.6% and 56.0%, respectively. 51 cases received standard protocol had poor responses at 3 (25.5%) and 6 months (41.2%). However, 124 patients received optimized protocol had better responses at 3 (41.1%, P = 0.14) and 6 (62.1%, P = 0.01). Higher incidences of infection (57.1% versus 37.9%, P = 0.02) and early mortality (17.9% versus 0.8%, P<0.001) occurred in patients received standard protocol compared with optimized protocol. The 5-year overall survival in favor of the optimized over standard rATG protocol (76.0% versus. 50.3%, P<0.001) was observed. By multivariate analysis, optimized protocol (RR = 2.21, P = 0.04), response at 3 months (RR = 10.31, P = 0.03) and shorter interval (<23 days) between diagnosis and initial dose of rATG (RR = 5.35, P = 0.002) were independent favorable predictors of overall survival. Conclusions Optimized instead of standard rATG protocol in combination with CSA remained efficacious as a first-line immunosuppressive regimen for SAA. PMID:23554855

Clinical evaluation of reducing acquisition time on single-photon emission computed tomography image quality using proprietary resolution recovery software.

PubMed

Aldridge, Matthew D; Waddington, Wendy W; Dickson, John C; Prakash, Vineet; Ell, Peter J; Bomanji, Jamshed B

2013-11-01

A three-dimensional model-based resolution recovery (RR) reconstruction algorithm that compensates for collimator-detector response, resulting in an improvement in reconstructed spatial resolution and signal-to-noise ratio of single-photon emission computed tomography (SPECT) images, was tested. The software is said to retain image quality even with reduced acquisition time. Clinically, any improvement in patient throughput without loss of quality is to be welcomed. Furthermore, future restrictions in radiotracer supplies may add value to this type of data analysis. The aims of this study were to assess improvement in image quality using the software and to evaluate the potential of performing reduced time acquisitions for bone and parathyroid SPECT applications. Data acquisition was performed using the local standard SPECT/CT protocols for 99mTc-hydroxymethylene diphosphonate bone and 99mTc-methoxyisobutylisonitrile parathyroid SPECT imaging. The principal modification applied was the acquisition of an eight-frame gated data set acquired using an ECG simulator with a fixed signal as the trigger. This had the effect of partitioning the data such that the effect of reduced time acquisitions could be assessed without conferring additional scanning time on the patient. The set of summed data sets was then independently reconstructed using the RR software to permit a blinded assessment of the effect of acquired counts upon reconstructed image quality as adjudged by three experienced observers. Data sets reconstructed with the RR software were compared with the local standard processing protocols; filtered back-projection and ordered-subset expectation-maximization. Thirty SPECT studies were assessed (20 bone and 10 parathyroid). The images reconstructed with the RR algorithm showed improved image quality for both full-time and half-time acquisitions over local current processing protocols (P<0.05). The RR algorithm improved image quality compared with local processing protocols and has been introduced into routine clinical use. SPECT acquisitions are now acquired at half of the time previously required. The method of binning the data can be applied to any other camera system to evaluate the reduction in acquisition time for similar processes. The potential for dose reduction is also inherent with this approach.

Improving the quality of child anthropometry: Manual anthropometry in the Body Imaging for Nutritional Assessment Study (BINA).

PubMed

Conkle, Joel; Ramakrishnan, Usha; Flores-Ayala, Rafael; Suchdev, Parminder S; Martorell, Reynaldo

2017-01-01

Anthropometric data collected in clinics and surveys are often inaccurate and unreliable due to measurement error. The Body Imaging for Nutritional Assessment Study (BINA) evaluated the ability of 3D imaging to correctly measure stature, head circumference (HC) and arm circumference (MUAC) for children under five years of age. This paper describes the protocol for and the quality of manual anthropometric measurements in BINA, a study conducted in 2016-17 in Atlanta, USA. Quality was evaluated by examining digit preference, biological plausibility of z-scores, z-score standard deviations, and reliability. We calculated z-scores and analyzed plausibility based on the 2006 WHO Child Growth Standards (CGS). For reliability, we calculated intra- and inter-observer Technical Error of Measurement (TEM) and Intraclass Correlation Coefficient (ICC). We found low digit preference; 99.6% of z-scores were biologically plausible, with z-score standard deviations ranging from 0.92 to 1.07. Total TEM was 0.40 for stature, 0.28 for HC, and 0.25 for MUAC in centimeters. ICC ranged from 0.99 to 1.00. The quality of manual measurements in BINA was high and similar to that of the anthropometric data used to develop the WHO CGS. We attributed high quality to vigorous training, motivated and competent field staff, reduction of non-measurement error through the use of technology, and reduction of measurement error through adequate monitoring and supervision. Our anthropometry measurement protocol, which builds on and improves upon the protocol used for the WHO CGS, can be used to improve anthropometric data quality. The discussion illustrates the need to standardize anthropometric data quality assessment, and we conclude that BINA can provide a valuable evaluation of 3D imaging for child anthropometry because there is comparison to gold-standard, manual measurements.

Effect of adding one 15-minute-walk on the day of surgery to fast-track rehabilitation after total knee arthroplasty: a randomized, single-blind study.

PubMed

Zietek, P; Zietek, J; Szczypior, K; Safranow, K

2015-06-01

Earlier and more intensive physiotherapy exercise after total knee arthroplasty (TKA) enhance recovery, but the best combination of intensity and duration has not been determined. To determine whether adding a single, 15-minute walk on the day of surgery to a fast-track rehabilitation protocol would reduce knee pain and improve knee function after TKA. A randomized single-blind study. Inpatient. Patients with primary osteoarthrosis after TKA. Patients undergoing TKA were randomly assigned to a standard, fast-track rehabilitation protocol consisting of a single, 15-minute walk with a high-rolling walker 4 to 6 hours after recovery from spinal anesthesia or to an intensive protocol, in which patients took a second 15-minute walk at least 3 hours after the first, only on the day of surgery. Outcomes were pain measured on a visual analog scale, Knee Society's (KSS) clinical and functional scores, Oxford knee scores, and Spielberger State-Trait Anxiety Inventory scores. Patients were blinded to group assignment. Since most data were non-normally distributed non-parametric tests were used. Groups were compared with Mann-Whitney U test (for continuous variables). Association between continuous variables was evaluated with Spearman`s rank correlation coefficient. Chi-square or Fisher's exact test was used to assess differences in categorical variables. Of 86 patients assessed for eligibility, 66 were randomly assigned. The 31 evaluable patients on the intensive protocol (mean age, 68 years; 18 women) did not differ significantly from the 31 (mean age, 70 years; 20 women) on the standard protocol on any baseline characteristic or on any outcome measure on any day. On the second postoperative day, pain while walking dropped from a mean of 6.1 to a mean of 4.9 in the intensive group and from 6.4 to 5.4 in the standard group. Results for pain at rest were 3.3 to 2.2, respectively, for the intensive group and 4.0 to 3.0 for the standard group. At 2 weeks, pain at rest was 2.8 in both groups, and pain while walking was 3.0, respectively, for the intensive group and 3.4 for the standard group. At 2 weeks, mean (SD) KSS clinical and KSS function scores were, respectively, 74.9 (12.5) and 51.6 (16.2) in the intensive group and 71.2 (14.3) and 46.3 (16.1) in the standard group. Older age correlated with decreasing knee function (rS=-0.43, P<0.001), and less knee flexion correlated with preoperatively higher state anxiety (rS=-0.37, P=0.005) and trait anxiety (rS=-0.29, P=0.027). The study is limited by its small sample. The fast-track program was not in line with the best available evidence following knee arthroplasty, because patients did not undergo such treatment as NMES. Finally, the intervention itself was modest. Adding an additional 15-minute walk to a fast-track rehabilitation protocol did not increase pain, but neither did it improve functional recovery. A 15-minute walk immediately after recovery from spinal anesthesia did not increase pain in patients with TKA. More intense exercise during this period might improve functional recovery without increasing pain.

Overcoming recruitment challenges in palliative care clinical trials.

PubMed

LeBlanc, Thomas W; Lodato, Jordan E; Currow, David C; Abernethy, Amy P

2013-11-01

Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research-especially participant recruitment-is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. The PCT was a 2 × 2 × 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach.

Comparing Short Dental Implants to Standard Dental Implants: Protocol for a Systematic Review.

PubMed

Rokn, Amir Reza; Keshtkar, Abbasali; Monzavi, Abbas; Hashemi, Kazem; Bitaraf, Tahereh

2018-01-18

Short dental implants have been proposed as a simpler, cheaper, and faster alternative for the rehabilitation of atrophic edentulous areas to avoid the disadvantages of surgical techniques for increasing bone volume. This review will compare short implants (4 to 8 mm) to standard implants (larger than 8 mm) in edentulous jaws, evaluating on the basis of marginal bone loss (MBL), survival rate, complications, and prosthesis failure. We will electronically search for randomized controlled trials comparing short dental implants to standard dental implants in the following databases: PubMed, Web of Science, EMBASE, Scopus, the Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov with English language restrictions. We will manually search the reference lists of relevant reviews and the included articles in this review. The following journals will also be searched: European Journal of Oral Implantology, Clinical Oral Implants Research, and Clinical Implant Dentistry and Related Research. Two reviewers will independently perform the study selection, data extraction and quality assessment (using the Cochrane Collaboration tool) of included studies. All meta-analysis procedures including appropriate effect size combination, sub-group analysis, meta-regression, assessing publication or reporting bias will be performed using Stata (Statacorp, TEXAS) version 12.1. Short implant effectiveness will be assessed using the mean difference of MBL in terms of weighted mean difference (WMD) and standardized mean difference (SMD) using Cohen's method. The combined effect size measures in addition to the related 95% confidence intervals will be estimated by a fixed effect model. The heterogeneity of the related effect size will be assessed using a Q Cochrane test and I2 measure. The MBL will be presented by a standardized mean difference with a 95% confidence interval. The survival rate of implants, prostheses failures, and complications will be reported using a risk ratio at 95% confidence interval (P<.05). The present protocol illustrates an appropriate method to perform the systematic review and ensures transparency for the completed review. The results will be published in a peer-reviewed journal and social networks. In addition, an ethics approval is not considered necessary. PROSPERO registration number: CRD42016048363; https://www.crd.york.ac.uk/PROSPERO/ display_record.asp?ID=CRD42016048363 (Archived by WebCite at http://www.webcitation.org/6wZ7Fntry). ©Amir Reza Rokn, Abbasali Keshtkar, Abbas Monzavi, Kazem Hashemi, Tahereh Bitaraf. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 18.01.2018.

Performance Evaluation of a PEM Scanner Using the NEMA NU 4—2008 Small Animal PET Standards

NASA Astrophysics Data System (ADS)

Luo, Weidong; Anashkin, Edward; Matthews, Christopher G.

2010-02-01

The recently published NEMA NU 4-2008 Standards has been specially designed for evaluating the performance of small animal PET scanners used in preclinical applications. In this paper, we report on the NU 4 performance of a clinical positron emission mammography (PEM) system. Since there are no PEM specific performance test protocols available, and the NU 2 protocol (intended for whole-body PET scanners) cannot be applied without modification due to the compact design of the PEM scanner, we decided to evaluate the NU 4 Standards as an alternative. We obtained the following results: Trans-axial spatial resolution 1.8 mm FWHM for high resolution reconstruction mode and 2.4 mm FWHM for standard resolution reconstruction mode with no significant variation within the field of view. The total system sensitivity was 0.16 cps/Bq. In image quality testing, the uniformity was found to be 3.9% STD at the standard resolution mode and 5.6% at the high resolution mode when measured with a 34 mm paddle separation. The NEMA NU 4-2008 Standards were found to be a practicable tool to evaluate the performance of the PEM scanner after some modifications to address the specifics of its detector configuration. Furthermore, the PEM scanner's in-plane spatial resolution was comparable to other small animal PET scanners with good image quality.

Uptake of a web-based oncology protocol system: how do cancer clinicians use eviQ cancer treatments online?

PubMed Central

2013-01-01

Background The use of computerized systems to support evidence-based practice is commonplace in contemporary medicine. Despite the prolific use of electronic support systems there has been relatively little research on the uptake of web-based systems in the oncology setting. Our objective was to examine the uptake of a web-based oncology protocol system (http://www.eviq.org.au) by Australian cancer clinicians. Methods We used web-logfiles and Google Analytics to examine the characteristics of eviQ registrants from October 2009-December 2011 and patterns of use by cancer clinicians during a typical month. Results As of December 2011, there were 16,037 registrants; 85% of whom were Australian health care professionals. During a typical month 87% of webhits occurred in standard clinical hours (08:00 to 18:00 weekdays). Raw webhits were proportional to the size of clinician groups: nurses (47% of Australian registrants), followed by doctors (20%), and pharmacists (14%). However, pharmacists had up to three times the webhit rate of other clinical groups. Clinicians spent five times longer viewing chemotherapy protocol pages than other content and the protocols viewed reflect the most common cancers: lung, breast and colorectal. Conclusions Our results demonstrate eviQ is used by a range of health professionals involved in cancer treatment at the point-of-care. Continued monitoring of electronic decision support systems is vital to understanding how they are used in clinical practice and their impact on processes of care and patient outcomes. PMID:23497080

Statistical controversies in clinical research: comparison of primary outcomes in protocols, public clinical-trial registries and publications: the example of oncology trials.

PubMed

Perlmutter, A S; Tran, V-T; Dechartres, A; Ravaud, P

2017-04-01

Protocols are often unavailable to peer-reviewers and readers. To detect outcome reporting bias (ORB), readers usually have to resort to publicly available descriptions of study design such as public clinical trial registries. We compared primary outcomes in protocols, ClinicalTrials.gov and publications of oncology trials and evaluated the use of ClinicalTrials.gov as compared with protocols in detecting discrepancies between planned and published outcomes. We searched for phase III oncology trials registered in ClinicalTrials.gov and published in the Journal of Clinical Oncology and New England Journal of Medicine between January 2014 and June 2015. We extracted primary outcomes reported in the protocol, ClinicalTrials.gov and the publication. First, we assessed the quality of primary outcome descriptions by using a published framework. Second, we evaluated modifications of primary outcomes between each source. Finally, we evaluated the agreement, specificity and sensitivity of detecting modifications between planned and published outcomes by using protocols or ClinicalTrials.gov. We included 65 trials, with 81 primary outcomes common among the 3 sources. The proportion of primary outcomes reporting all items from the framework was 73%, 22%, and 75% for protocols, ClinicalTrials.gov and publications, respectively. Eight (12%) trials presented a discrepancy between primary outcomes reported in the protocol and in the publication. Twelve (18.5%) trials presented a discrepancy between primary outcomes registered at ClinicalTrials.gov and in publications. We found a moderate agreement in detecting discrepant reporting of outcomes by using protocols or ClinicalTrials.gov [κ = 0.53, 95% confidence interval (0.25-0.81)]. Using ClinicalTrials.gov to detect discrepant reporting of outcomes showed high specificity (89.5%) but lacked sensitivity (75%) as compared with use of protocols. In oncology trials, primary outcome descriptions in ClinicalTrials.gov are often of low quality and may not reflect what is in the protocol, thus limiting the detection of modifications between planned and published outcomes. © The Author 2016. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oup.com.

An in silico method to identify computer-based protocols worthy of clinical study: An insulin infusion protocol use case

PubMed Central

Wong, Anthony F; Pielmeier, Ulrike; Haug, Peter J; Andreassen, Steen

2016-01-01

Objective Develop an efficient non-clinical method for identifying promising computer-based protocols for clinical study. An in silico comparison can provide information that informs the decision to proceed to a clinical trial. The authors compared two existing computer-based insulin infusion protocols: eProtocol-insulin from Utah, USA, and Glucosafe from Denmark. Materials and Methods The authors used eProtocol-insulin to manage intensive care unit (ICU) hyperglycemia with intravenous (IV) insulin from 2004 to 2010. Recommendations accepted by the bedside clinicians directly link the subsequent blood glucose values to eProtocol-insulin recommendations and provide a unique clinical database. The authors retrospectively compared in silico 18 984 eProtocol-insulin continuous IV insulin infusion rate recommendations from 408 ICU patients with those of Glucosafe, the candidate computer-based protocol. The subsequent blood glucose measurement value (low, on target, high) was used to identify if the insulin recommendation was too high, on target, or too low. Results Glucosafe consistently provided more favorable continuous IV insulin infusion rate recommendations than eProtocol-insulin for on target (64% of comparisons), low (80% of comparisons), or high (70% of comparisons) blood glucose. Aggregated eProtocol-insulin and Glucosafe continuous IV insulin infusion rates were clinically similar though statistically significantly different (Wilcoxon signed rank test P = .01). In contrast, when stratified by low, on target, or high subsequent blood glucose measurement, insulin infusion rates from eProtocol-insulin and Glucosafe were statistically significantly different (Wilcoxon signed rank test, P < .001), and clinically different. Discussion This in silico comparison appears to be an efficient nonclinical method for identifying promising computer-based protocols. Conclusion Preclinical in silico comparison analytical framework allows rapid and inexpensive identification of computer-based protocol care strategies that justify expensive and burdensome clinical trials. PMID:26228765

CPM Test-Retest Reliability: "Standard" vs "Single Test-Stimulus" Protocols.

PubMed

Granovsky, Yelena; Miller-Barmak, Adi; Goldstein, Oren; Sprecher, Elliot; Yarnitsky, David

2016-03-01

Assessment of pain inhibitory mechanisms using conditioned pain modulation (CPM) is relevant clinically in prediction of pain and analgesic efficacy. Our objective is to provide necessary estimates of intersession CPM reliability, to enable transformation of the CPM paradigm into a clinical tool. Two cohorts of young healthy subjects (N = 65) participated in two dual-session studies. In Study I, a Bath-Thermode CPM protocol was used, with hot water immersion and contact heat as conditioning- and test-stimuli, respectively, in a classical parallel CPM design introducing test-stimulus first, and then the conditioning- and repeated test-stimuli in parallel. Study II consisted of two CPM protocols: 1) Two-Thermodes, one for each of the stimuli, in the same parallel design as above, and 2) single test-stimulus (STS) protocol with a single administration of a contact heat test-stimulus, partially overlapped in time by a remote shorter contact heat as conditioning stimulus. Test-retest reliability was assessed within 3-7 days. The STS-CPM had superior reliability intraclass correlation (ICC 2 ,: 1  = 0.59) over Bath-Thermode (ICC 2 ,: 1  = 0.34) or Two-Thermodes (ICC 2 ,: 1  = 0.21) protocols. The hand immersion conditioning pain had higher reliability than thermode pain (ICC 2 ,: 1  = 0.76 vs ICC 2 ,: 1  = 0.16). Conditioned test-stimulus pain scores were of good (ICC 2 ,: 1  = 0.62) or fair (ICC 2 ,: 1  = 0.43) reliability for the Bath-Thermode and the STS, respectively, but not for the Two-Thermodes protocol (ICC 2 ,: 1  = 0.20). The newly developed STS-CPM paradigm was more reliable than other CPM protocols tested here, and should be further investigated for its clinical relevance. It appears that large contact size of the conditioning-stimulus and use of single rather than dual test-stimulus pain contribute to augmentation of CPM reliability. © 2015 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Interoperability in the Planetary Science Archive (PSA)

NASA Astrophysics Data System (ADS)

Rios Diaz, C.

2017-09-01

The protocols and standards currently being supported by the recently released new version of the Planetary Science Archive at this time are the Planetary Data Access Protocol (PDAP), the EuroPlanet- Table Access Protocol (EPN-TAP) and Open Geospatial Consortium (OGC) standards. We explore these protocols in more detail providing scientifically useful examples of their usage within the PSA.

Physician Assistant/Sr. Nurse Practitioner | Center for Cancer Research

Cancer.gov

PROGRAM DESCRIPTION Within the Leidos Biomedical Research Inc.’s Clinical Research Directorate, the Clinical Monitoring Research Program (CMRP) provides high-quality comprehensive and strategic operational support to the high-profile domestic and international clinical research initiatives of the National Cancer Institute (NCI), National Institute of Allergy and Infectious Diseases (NIAID), Clinical Center (CC), National Institute of Heart, Lung and Blood Institute (NHLBI), National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Center for Advancing Translational Sciences (NCATS), National Institute of Neurological Disorders and Stroke (NINDS), and the National Institute of Mental Health (NIMH). Since its inception in 2001, CMRP’s ability to provide rapid responses, high-quality solutions, and to recruit and retain experts with a variety of backgrounds to meet the growing research portfolios of NCI, NIAID, CC, NHLBI, NIAMS, NCATS, NINDS, and NIMH has led to the considerable expansion of the program and its repertoire of support services. CMRP’s support services are strategically aligned with the program’s mission to provide comprehensive, dedicated support to assist National Institutes of Health researchers in providing the highest quality of clinical research in compliance with applicable regulations and guidelines, maintaining data integrity, and protecting human subjects. For the scientific advancement of clinical research, CMRP services include comprehensive clinical trials, regulatory, pharmacovigilance, protocol navigation and development, and programmatic and project management support for facilitating the conduct of 400+ Phase I, II, and III domestic and international trials on a yearly basis. These trials investigate the prevention, diagnosis, treatment of, and therapies for cancer, influenza, HIV, and other infectious diseases and viruses such as hepatitis C, tuberculosis, malaria, and Ebola virus; heart, lung, and blood diseases and conditions; parasitic infections; rheumatic and inflammatory diseases; and rare and neglected diseases. CMRP’s collaborative approach to clinical research and the expertise and dedication of staff to the continuation and success of the program’s mission has contributed to improving the overall standards of public health on a global scale. The Clinical Monitoring Research Program (CMRP) provides quality Physician Assistant and/or Nurse Practitioner clinical research services in support of the Urologic Oncology Branch (UOB), National Cancer Institute’s (NCI’s), Center for Cancer Research (CCR). KEY ROLES/RESPONSIBILITIES - THIS POSITION IS CONTINGENT UPON FUNDING APPROVAL The Physician Extender: Provides clinical care in collaboration with physicians and health care professionals. Performs a comprehensive physical assessment and documents findings in the appropriate format following institutional and protocol standards. Assesses the patient's general health status through observation and the use of appropriate screening procedures. Acquires patient data through health history taking that includes family history and significant social information. Explains the care management/discharge plan to all members of the covering team (inpatient NPs, attendings) at sign-out. Provides teaching and guidance related to the patient's current state of health and understanding of his/her disease to promote optimal performance. Coordinates study enrollment, collaborates with nursing staff to provide protocol treatment, and provides follow-up care for patients participating in clinical trials. Assists the Principal Investigator (PI) in assuring informed consent forms have been signed, obtaining written consent for treatment, pharmacokinetics, and assessing patients on the study for complications. Calculates the dose of and prescribes chemotherapy, investigational agents, medications, intravenous fluids and blood products according to established protocol, institutional, and practice guidelines. Provides guidance in the management of specific problems for the patient resulting from chemotherapy, immunotherapy or other treatments. Manages appropriate referrals to other specialists as indicated. Screens new patient calls and provides phone triage for active patients. Orders radiological studies, following protocols and patient care guidelines. Orders and interprets lab studies. Attends new patient consultations with the patient and family for the purpose of explaining the diagnosis, protocol, and treatment program, and establishing a rapport. Completes initial and follow-up assessment(s), progress notes and written correspondence to multidisciplinary personnel. Serves as a clinical liaison to area hospices and/or home care agencies as needed or as appropriate. Acts as a clinical liaison between inpatient and outpatient nurses in order to provide continuity of care to the hospitalized patient. Maintains documented evidence of weekly case review with the collaborating physician. Attends and participates in multidisciplinary meetings. Practices within boundaries established by the Nurse Practice Act, State of Maryland and Medical Board of the Clinical Center. Liaises with Leidos Biomed and various NCI staff to initiate and complete tasks relating to medicine and clinical protocols, and all activities related to nursing. Performs clinical data recording and medical chart entries. Dictates admission and discharge summaries. This position is located in Bethesda, Maryland.

Protocols for the dosimetry of high-energy photon and electron beams: a comparison of the IAEA TRS-398 and previous international Codes of Practice

NASA Astrophysics Data System (ADS)

Andreo, Pedro; Saiful Huq, M.; Westermark, Mathias; Song, Haijun; Tilikidis, Aris; DeWerd, Larry; Shortt, Ken

2002-09-01

A new international Code of Practice for radiotherapy dosimetry co-sponsored by several international organizations has been published by the IAEA, TRS-398. It is based on standards of absorbed dose to water, whereas previous protocols (TRS-381 and TRS-277) were based on air kerma standards. To estimate the changes in beam calibration caused by the introduction of TRS-398, a detailed experimental comparison of the dose determination in reference conditions in high-energy photon and electron beams has been made using the different IAEA protocols. A summary of the formulation and reference conditions in the various Codes of Practice, as well as of their basic data, is presented first. Accurate measurements have been made in 25 photon and electron beams from 10 clinical accelerators using 12 different cylindrical and plane-parallel chambers, and dose ratios under different conditions of TRS-398 to the other protocols determined. A strict step-by-step checklist was followed by the two participating clinical institutions to ascertain that the resulting calculations agreed within tenths of a per cent. The maximum differences found between TRS-398 and the previous Codes of Practice TRS-277 (2nd edn) and TRS-381 are of the order of 1.5-2.0%. TRS-398 yields absorbed doses larger than the previous protocols, around 1.0% for photons (TRS-277) and for electrons (TRS-381 and TRS-277) when plane-parallel chambers are cross-calibrated. For the Markus chamber, results show a very large variation, although a fortuitous cancellation of the old stopping powers with the ND,w/NK ratios makes the overall discrepancy between TRS-398 and TRS-277 in this case smaller than for well-guarded plane-parallel chambers. Chambers of the Roos-type with a 60Co ND,w calibration yield the maximum discrepancy in absorbed dose, which varies between 1.0% and 1.5% for TRS-381 and between 1.5% and 2.0% for TRS-277. Photon beam calibrations using directly measured or calculated TPR20,10 from a percentage dose data at SSD = 100 cm were found to be indistinguishable. Considering that approximately 0.8% of the differences between TRS-398 and the NK-based protocols are caused by the change to the new type of standards, the remaining difference in absolute dose is due either to a close similarity in basic data or to a fortuitous cancellation of the discrepancies in data and type of chamber calibration. It is emphasized that the NK-ND,air and ND,w formalisms have very similar uncertainty when the same criteria are used for both procedures. Arguments are provided in support of the recommendation for a change in reference dosimetry based on standards of absorbed dose to water.

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol

PubMed Central

Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Haxby Abbott, J.; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S.

2015-01-01

Background Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. Objective The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist–instructed home exercise leads to greater reductions in pain and improvements in function. Design An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. Setting The study will be conducted in a community setting. Participants The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Intervention Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Measurements Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. Limitations A self-reported diagnosis of persistent hip pain will be used. Conclusions The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist–instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. PMID:26023213

Effects of Adding an Internet-Based Pain Coping Skills Training Protocol to a Standardized Education and Exercise Program for People With Persistent Hip Pain (HOPE Trial): Randomized Controlled Trial Protocol.

PubMed

Bennell, Kim L; Rini, Christine; Keefe, Francis; French, Simon; Nelligan, Rachel; Kasza, Jessica; Forbes, Andrew; Dobson, Fiona; Abbott, J Haxby; Dalwood, Andrew; Vicenzino, Bill; Harris, Anthony; Hinman, Rana S

2015-10-01

Persistent hip pain in older people is usually due to hip osteoarthritis (OA), a major cause of pain, disability, and psychological dysfunction. The purpose of this study is to evaluate whether adding an Internet-based pain coping skills training (PCST) protocol to a standardized intervention of education followed by physical therapist-instructed home exercise leads to greater reductions in pain and improvements in function. An assessor-, therapist-, and participant-blinded randomized controlled trial will be conducted. The study will be conducted in a community setting. The participants will be 142 people over 50 years of age with self-reported hip pain consistent with hip OA. Participants will be randomly allocated to: (1) a control group receiving a 24-week standardized intervention comprising an 8-week Internet-based education package followed by 5 individual physical therapy exercise sessions plus home exercises (3 times weekly) or (2) a PCST group receiving an 8-week Internet-based PCST protocol in addition to the control intervention. Outcomes will be measured at baseline and 8, 24, and 52 weeks, with the primary time point at 24 weeks. Primary outcomes are hip pain on walking and self-reported physical function. Secondary outcomes include health-related quality-of-life, participant-perceived treatment response, self-efficacy for pain management and function, pain coping attempts, pain catastrophizing, and physical activity. Measurements of adherence, adverse events, use of health services, and process measures will be collected at 24 and 52 weeks. Cost-effectiveness will be assessed at 52 weeks. A self-reported diagnosis of persistent hip pain will be used. The findings will help determine whether adding an Internet-based PCST protocol to standardized education and physical therapist-instructed home exercise is more effective than education and exercise alone for persistent hip pain. This study has the potential to guide clinical practice toward innovative modes of psychosocial health care provision. © 2015 American Physical Therapy Association.

Clinical Components of Telemedicine Programs for Diabetic Retinopathy.

PubMed

Horton, Mark B; Silva, Paolo S; Cavallerano, Jerry D; Aiello, Lloyd Paul

2016-12-01

Diabetic retinopathy is a leading cause of new-onset vision loss worldwide. Treatments supported by large clinical trials are effective in preserving vision, but many persons do not receive timely diagnosis and treatment of diabetic retinopathy, which is typically asymptomatic when most treatable. Telemedicine evaluation to identify diabetic retinopathy has the potential to improve access to care, but there are no universal standards regarding camera choice or protocol for ocular telemedicine. We review the literature regarding the impact of imaging device, number and size of retinal images, pupil dilation, type of image grader, and diagnostic accuracy on telemedicine assessment for diabetic retinopathy. Telemedicine assessment of diabetic retinopathy has the potential to preserve vision, but further development of telemedicine specific technology and standardization of operations are needed to better realize its potential.

A neuromuscular exercise programme versus standard care for patients with traumatic anterior shoulder instability: study protocol for a randomised controlled trial (the SINEX study).

PubMed

Eshoj, Henrik; Rasmussen, Sten; Frich, Lars Henrik; Hvass, Inge; Christensen, Robin; Jensen, Steen Lund; Søndergaard, Jens; Søgaard, Karen; Juul-Kristensen, Birgit

2017-02-28

Anterior shoulder dislocation is a common injury and may have considerable impact on shoulder-related quality of life (QoL). If not warranted for initial stabilising surgery, patients are mostly left with little to no post-traumatic rehabilitation. This may be due to lack of evidence-based exercise programmes. In similar, high-impact injuries (e.g. anterior cruciate ligament tears in the knee) neuromuscular exercise has shown large success in improving physical function and QoL. Thus, the objective of this trial is to compare a nonoperative neuromuscular exercise shoulder programme with standard care in patients with traumatic anterior shoulder dislocations (TASD). Randomised, assessor-blinded, controlled, multicentre trial. Eighty patients with a TASD will be recruited from three orthopaedic departments in Denmark. Patients with primary or recurrent anterior shoulder dislocations due to at least one traumatic event will be randomised to 12 weeks of either a standardised, individualised or physiotherapist-supervised neuromuscular shoulder exercise programme or standard care (self-managed shoulder exercise programme). Patients will be stratified according to injury status (primary or recurrent). Primary outcome will be change from baseline to 12 weeks in the patient-reported QoL outcome questionnaire, the Western Ontario Shoulder Instability Index (WOSI). This trial will be the first study to compare the efficacy and safety of two different nonoperative exercise treatment strategies for patients with TASD. Moreover, this is also the first study to investigate nonoperative treatment effects in patients with recurrent shoulder dislocations. Lastly, this study will add knowledge to the shared decision-making process of treatment strategies for clinical practice. ClinicalTrials.gov, identifier: NCT02371928 . Registered on 9 February 2015 at the National Institutes of Health Clinical Trials Protocol Registration System.

Development, validation and operating room-transfer of a six-step laparoscopic training program for the vesicourethral anastomosis.

PubMed

Klein, Jan; Teber, Dogu; Frede, Tom; Stock, Christian; Hruza, Marcel; Gözen, Ali; Seemann, Othmar; Schulze, Michael; Rassweiler, Jens

2013-03-01

Development and full validation of a laparoscopic training program for stepwise learning of a reproducible application of a standardized laparoscopic anastomosis technique and integration into the clinical course. The training of vesicourethral anastomosis (VUA) was divided into six simple standardized steps. To fix the objective criteria, four experienced surgeons performed the stepwise training protocol. Thirty-eight participants with no previous laparoscopic experience were investigated in their training performance. The times needed to manage each training step and the total training time were recorded. The integration into the clinical course was investigated. The training results and the corresponding steps during laparoscopic radical prostatectomy (LRP) were analyzed. Data analysis of corresponding operating room (OR) sections of 793 LRP was performed. Based on the validity, criteria were determined. In the laboratory section, a significant reduction of OR time for every step was seen in all participants. Coordination: 62%; longitudinal incision: 52%; inverted U-shape incision: 43%; plexus: 47%. Anastomosis catheter model: 38%. VUA: 38%. The laboratory section required a total time of 29 hours (minimum: 16 hours; maximum: 42 hours). All participants had shorter execution times in the laboratory than under real conditions. The best match was found within the VUA model. To perform an anastomosis under real conditions, 25% more time was needed. By using the training protocol, the performance of the VUA is comparable to that of an surgeon with experience of about 50 laparoscopic VUA. Data analysis proved content, construct, and prognostic validity. The use of stepwise training approaches enables a surgeon to learn and reproduce complex reconstructive surgical tasks: eg, the VUA in a safe environment. The validity of the designed system is given at all levels and should be used as a standard in the clinical surgical training in laparoscopic reconstructive urology.

One Approach for Transitioning the iNET Standards into the IRIG 106 Telemetry Standards

DTIC Science & Technology

2015-05-26

Protocol Suite. Figure 1 illustrates the Open Systems Interconnection ( OSI ) Model, the corresponding TCP/IP Model, and the major components of the TCP...IP Protocol Suite. Figure 2 represents the iNET-specific protocols layered onto the TCP/IP Model. Figure 1. OSI and TCP/IP Model with TCP/IP...Protocol Suite TCP/IP Protocol Suite Major Components IPv4 IPv6 TCP/IP Model OSI Model Application Presentation

International Guillain-Barré Syndrome Outcome Study: protocol of a prospective observational cohort study on clinical and biological predictors of disease course and outcome in Guillain-Barré syndrome.

PubMed

Jacobs, Bart C; van den Berg, Bianca; Verboon, Christine; Chavada, Govindsinh; Cornblath, David R; Gorson, Kenneth C; Harbo, Thomas; Hartung, Hans-Peter; Hughes, Richard A C; Kusunoki, Susumu; van Doorn, Pieter A; Willison, Hugh J

2017-06-01

Guillain-Barré syndrome (GBS) is an acute polyradiculoneuropathy with a highly variable clinical presentation, course, and outcome. The factors that determine the clinical variation of GBS are poorly understood which complicates the care and treatment of individual patients. The protocol of the ongoing International GBS Outcome Study (IGOS), a prospective, observational, multicenter cohort study that aims to identify the clinical and biological determinants and predictors of disease onset, subtype, course and outcome of GBS is presented here. Patients fulfilling the diagnostic criteria for GBS, regardless of age, disease severity, variant forms, or treatment, can participate if included within 2 weeks after onset of weakness. Information about demography, preceding infections, clinical features, diagnostic findings, treatment, course, and outcome is collected. In addition, cerebrospinal fluid and serial blood samples for serum and DNA is collected at standard time points. The original aim was to include at least 1,000 patients with a follow-up of 1-3 years. Data are collected via a web-based data entry system and stored anonymously. IGOS started in May 2012 and by January 2017 included more than 1,400 participants from 143 active centers in 19 countries across 5 continents. The IGOS data/biobank is available for research projects conducted by expertise groups focusing on specific topics including epidemiology, diagnostic criteria, clinimetrics, electrophysiology, antecedent events, antibodies, genetics, prognostic modeling, treatment effects, and long-term outcome of GBS. The IGOS will help to standardize the international collection of data and biosamples for future research of GBS. © 2017 Peripheral Nerve Society.

Standardized radiologic protocol for the study of common coccygodynia and characteristics of the lesions observed in the sitting position. Clinical elements differentiating luxation, hypermobility, and normal mobility.

PubMed

Maigne, J Y; Tamalet, B

1996-11-15

Ninety-one patients with common coccygodynia and 47 control subjects prospectively underwent dynamic radiographic imagery. To standardize the radiologic protocol to better define normal and abnormal mobility of the coccyx, and to study clinical parameters useful in classifying and differentiating the lesions. In a previous study, comparison of films taken in the sitting and standing positions allowed to individualize two distinct coccygeal lesions: luxation and hypermobility. Measurement technique was precise and reproducible, but the control group was not pain-free. No specific clinical features were described. Standing films were made first. Control subjects were healthy volunteers. The following items were recorded: presence of an initial traumatic event, elapsed time before investigation, body mass index, presence of an acute pain when passing from sitting to standing, effect of intradiscal steroid injection, and angle of the coccyx with respect to the seat. Hypermobility was defined as a flexion of more than 25 degrees, luxation by displacement of more than 25% of the coccyx. The base angle is a good predictor of the direction in which the coccyx moves when sitting. In the "luxation" group, a history of initial trauma, a shorter clinical course, pain when standing up, increased body mass index, and satisfactory results with intradiscal injection were found more frequently than in the "normal" group. The "hypermobility" group had characteristics between these two groups. Common coccygodynia is associated in 48.4% of patients with a luxation or hypermobility of the coccyx. A distinct clinical presentation was found in individuals with luxation of the coccyx.

Independent but coordinated trials: insights from the practice-based Opportunities for Weight Reduction Trials Collaborative Research Group.

PubMed

Yeh, Hsin-Chieh; Clark, Jeanne M; Emmons, Karen E; Moore, Reneé H; Bennett, Gary G; Warner, Erica T; Sarwer, David B; Jerome, Gerald J; Miller, Edgar R; Volger, Sheri; Louis, Thomas A; Wells, Barbara; Wadden, Thomas A; Colditz, Graham A; Appel, Lawrence J

2010-08-01

The National Heart, Lung, and Blood Institute (NHLBI) funded three institutions to conduct effectiveness trials of weight loss interventions in primary care settings. Unlike traditional multi-center clinical trials, each study was established as an independent trial with a distinct protocol. Still, efforts were made to coordinate and standardize several aspects of the trials. The three trials formed a collaborative group, the 'Practice-based Opportunities for Weight Reduction (POWER) Trials Collaborative Research Group.' We describe the common and distinct features of the three trials, the key characteristics of the collaborative group, and the lessons learned from this novel organizational approach. The Collaborative Research Group consists of three individual studies: 'Be Fit, Be Well' (Washington University in St. Louis/Harvard University), 'POWER Hopkins' (Johns Hopkins), and 'POWER-UP' (University of Pennsylvania). There are a total of 15 participating clinics with ~1100 participants. The common primary outcome is change in weight at 24 months of follow-up, but each protocol has trial-specific elements including different interventions and different secondary outcomes. A Resource Coordinating Unit at Johns Hopkins provides administrative support. The Collaborative Research Group established common components to facilitate potential cross-site comparisons. The main advantage of this approach is to develop and evaluate several interventions, when there is insufficient evidence to test one or two approaches, as would be done in a traditional multi-center trial. The challenges of the organizational design include the complex decision-making process, the extent of potential data pooling, time intensive efforts to standardize reports, and the additional responsibilities of the DSMB to monitor three distinct protocols.

STANDARD MEASUREMENT PROTOCOLS - FLORIDA RADON RESEARCH PROGRAM

EPA Science Inventory

The manual, in support of the Florida Radon Research Program, contains standard protocols for key measurements where data quality is vital to the program. t contains two sections. he first section, soil measurements, contains field sampling protocols for soil gas permeability and...

Improving Warfarin Management Within the Medical Home: A Health-System Approach.

PubMed

Rose, Anne E; Robinson, Erin N; Premo, Joan A; Hauschild, Lori J; Trapskin, Philip J; McBride, Ann M

2017-03-01

Anticoagulation clinics have been considered the optimal strategy for warfarin management with demonstrated improved patient outcomes through increased time in therapeutic international normalized ratio (INR) range, decreased critical INR values, and decreased anticoagulation-related adverse events. However, not all health systems are able to support a specialized anticoagulation clinic or may see patient volume exceed available anticoagulation clinic resources. The purpose of this study was to utilize an anticoagulation clinic model to standardize warfarin management in a primary care clinic setting. A warfarin management program was developed that included standardized patient assessment, protocolized warfarin-dosing algorithm, and electronic documentation and reporting tools. Primary care clinics were targeted for training and implementation of this program. The warfarin management program was applied to over 2000 patients and implemented at 39 clinic sites. A total of 160 nurses and 15 pharmacists were trained on the program. Documentation of warfarin dose and date of the next INR increased from 70% to 90% (P <.0001), documentation occurring within 24 hours of the INR result increased from 75% to 87% (P <.0001), and monitoring the INR at least every 4 weeks increased from 71% to 83% (P <.0001) per patient encounter. Time in therapeutic INR range improved from 65% to 75%. Incorporating a standardized approach to warfarin management in the primary care setting significantly improves warfarin-related documentation and time in therapeutic INR range. Copyright © 2016 Elsevier Inc. All rights reserved.

Evaluation of a cleanser for petroleum-contaminated skin.

PubMed

Phieffer, Laura S; Banks, David M; Bosse, Michael J; Meyer, Martha H; Meyer, Ralph A; Smith, Kevin

2003-12-01

Extremity injuries contaminated with petroleum products pose clinical dilemmas. This project was designed to evaluate the efficacy of a dioctyl sulfosuccinate (DS) solution for cleansing petroleum-contaminated skin. One hundred Sprague-Dawley rats were subjected to a contamination protocol followed by a cleansing procedure. Four petroleum contaminants and five cleansing solutions were selected. The protocol consisted of shaving, initial punch biopsy, contamination, precleansing punch biopsy, standardized scrub protocol, and postcleansing punch biopsy. Biopsy samples were analyzed for petroleum residue using fluorometry. The 10% DS solution had the highest reduction of crude oil, grease, and tar: 99.6 +/- 0.4% (mean +/- SD) contaminant reduction for crude oil, 99.8 +/- 0.2% for grease, and 99.8 +/- 0.2% for tar. The other cleansers showed less efficacy (p < 0.05). Concentrated DS appears to be significantly more effective at cleaning petroleum products from skin than the commonly chosen surgical and commercial cleansers.

Task based rehabilitation protocol for elite athletes following Anterior Cruciate ligament reconstruction: a clinical commentary.

PubMed

Herrington, Lee; Myer, Gregory; Horsley, Ian

2013-11-01

Anterior Cruciate ligament (ACL) injuries are one of the most common and devastating knee injuries sustained whilst participating in sport. ACL reconstruction (ACLR) remains the standard approach for athletes who aim to return to high level sporting activities but the outcome from surgery is not assured. Secondary morbidities and an inability to return to the same competitive level are common following ACLR. One factor which might be linked to these sub-optimal outcomes may be a failure to have clearly defined performance criteria for return to activity and sport. This paper presents a commentary describing a structured return to sport rehabilitation protocol for athletes following ACLR. The protocol was developed from synthesis of the available literature and consensus of physiotherapists and strength and conditioning coaches based in the home country Institute of Sports within the United Kingdom. Copyright © 2013 Elsevier Ltd. All rights reserved.

Clinical accuracy of inflationary oscillometry in pregnancy and pre-eclampsia: Omron-MIT Elite.

PubMed

Chung, Y; Brochut, M C; de Greeff, A; Shennan, A H

2012-10-01

To evaluate the accuracy of the Omron MIT Elite in pregnancy and pre-eclampsia according to the British Hypertension Society protocol (BHS). Prospective observational study. Antenatal clinics and wards at St. Thomas' Hospital (London, UK). Forty-five pregnant women including 15 with pre-eclampsia. Nine sequential same arm blood pressure (BP) measurements were taken from each woman by trained observers, alternating between mercury sphygmomanometry and the test device. Grading criteria of the BHS protocol (A/B grade=pass; C/D=fail). The Omron MIT Elite achieved a grade A/A in both pregnancy and pre-eclampsia. The mean difference (SD) between the mercury standard and the device in pregnancy was -1.1 (5.2)mmHg and 1.5 (4.8)mmHg for systolic and diastolic BP respectively compared to 0.2 (5.3)mmHg and 2.2 (5.5)mmHg in pre-eclampsia. The Omron MIT Elite can be recommended for use in pregnancy and pre-eclampsia according to the BHS protocol. To date, this is the most accurate automated BP device validated in pre-eclampsia. Copyright © 2012. Published by Elsevier B.V.

A feasible repetitive transcranial magnetic stimulation clinical protocol in migraine prevention.

PubMed

Zardouz, Shawn; Shi, Lei; Leung, Albert

2016-01-01

This case series was conducted to determine the clinical feasibility of a repetitive transcranial magnetic stimulation protocol for the prevention of migraine (with and without aura). Five patients with migraines underwent five repetitive transcranial magnetic stimulation sessions separated in 1- to 2-week intervals for a period of 2 months at a single tertiary medical center. Repetitive transcranial magnetic stimulation was applied to the left motor cortex with 2000 pulses (20 trains with 1s inter-train interval) delivered per session, at a frequency of 10 Hz and 80% resting motor threshold. Pre- and post-treatment numerical rating pain scales were collected, and percent reductions in intensity, frequency, and duration were generated. An average decrease in 37.8%, 32.1%, and 31.2% were noted in the intensity, frequency, and duration of migraines post-repetitive transcranial magnetic stimulation, respectively. A mean decrease in 1.9±1.0 (numerical rating pain scale ± standard deviation; range: 0.4-2.8) in headache intensity scores was noted after the repetitive transcranial magnetic stimulation sessions. The tested repetitive transcranial magnetic stimulation protocol is a well-tolerated, safe, and effective method for migraine prevention.

What are the keys to successful adrenal venous sampling (AVS) in patients with primary aldosteronism?

PubMed

Young, William F; Stanson, Anthony W

2009-01-01

Adrenal venous sampling (AVS) is the criterion standard to distinguish between unilateral and bilateral adrenal disease in patients with primary aldosteronism. The keys to successful AVS include appropriate patient selection, careful patient preparation, focused technical expertise, defined protocol, and accurate data interpretation. The use of AVS should be based on patient preferences, patient age, clinical comorbidities, and the clinical probability of finding an aldosterone-producing adenoma. AVS is optimally performed in the fasting state in the morning. AVS is an intricate procedure because the right adrenal vein is small and may be difficult to locate - the success rate depends on the proficiency of the angiographer. The key factors that determine the successful catheterization of both adrenal veins are experience, dedication and repetition. With experience, and focusing the expertise to 1 or 2 radiologists at a referral centre, the AVS success rate can be as high as 96%. A centre-specific, written protocol is mandatory. The protocol should be developed by an interested group of endocrinologists, radiologists and laboratory personnel. Safeguards should be in place to prevent mislabelling of the blood tubes in the radiology suite and to prevent sample mix-up in the laboratory.

WE-A-BRD-01: Innovation in Radiation Therapy Planning I: Knowledge Guided Treatment Planning

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

Wu, Q; Olsen, L

2014-06-15

Intensity modulated radiation therapy (IMRT) and Volumetric Modulated Arc Therapy (VMAT) offer the capability of normal tissues and organs sparing. However, the exact amount of sparing is often unknown until the plan is complete. This lack of prior guidance has led to the iterative, trial and-error approach in current planning practice. Even with this effort the search for patient-specific optimal organ sparing is still strongly influenced by planner's experience. While experience generally helps in maximizing the dosimetric advantages of IMRT/VMAT, there have been several reports showing unnecessarily high degree of plan quality variability at individual institutions and amongst different institutions,more » even with a large amount of experience and the best available tools. Further, when physician and physicist evaluate a plan, the dosimetric quality of the plan is often compared with a standard protocol that ignores individual patient anatomy and tumor characteristic variations. In recent years, developments of knowledge models for clinical IMRT/VMAT planning guidance have shown promising clinical potentials. These knowledge models extract past expert clinical experience into mathematical models that predict dose sparing references at patient-specific level. For physicians and planners, these references provide objective values that reflect best achievable dosimetric constraints. For quality assurance, applying patient-specific dosimetry requirements will enable more quantitative and objective assessment of protocol compliance for complex IMRT planning. Learning Objectives: Modeling and representation of knowledge for knowledge-guided treatment planning. Demonstrations of knowledge-guided treatment planning with a few clinical caanatomical sites. Validation and evaluation of knowledge models for cost and quality effective standardization of plan optimization.« less

Wear measurement of dental tissues and materials in clinical studies: A systematic review.

PubMed

Wulfman, C; Koenig, V; Mainjot, A K

2018-06-01

This study aims to systematically review the different methods used for wear measurement of dental tissues and materials in clinical studies, their relevance and reliability in terms of accuracy and precision, and the performance of the different steps of the workflow taken independently. An exhaustive search of clinical studies related to wear of dental tissues and materials reporting a quantitative measurement method was conducted. MedLine, Embase, Scopus, Cochrane Library and Web of Science databases were used. Prospective studies, pilot studies and case series (>10 patients), as long as they contained a description of wear measurement methodology. Only studies published after 1995 were considered. After duplicates' removal, 495 studies were identified, and 41 remained for quantitative analysis. Thirty-four described wear-measurement protocols, using digital profilometry and superimposition, whereas 7 used alternative protocols. A specific form was designed to analyze the risk of bias. The methods were described in terms of material analyzed; study design; device used for surface acquisition; matching software details and settings; type of analysis (vertical height-loss measurement vs volume loss measurement); type of area investigated (entire occlusal area or selective areas); and results. There is a need of standardization of clinical wear measurement. Current methods exhibit accuracy, which is not sufficient to monitor wear of restorative materials and tooth tissues. Their performance could be improved, notably limiting the use of replicas, using standardized calibration procedures and positive controls, optimizing the settings of scanners and matching softwares, and taking into account unusable data. Copyright © 2018 The Academy of Dental Materials. Published by Elsevier Inc. All rights reserved.

Recurrent hemorrhage after western diamondback rattlesnake envenomation treated with crotalidae polyvalent immune fab (ovine).

PubMed

Fazelat, Joyia; Teperman, Sheldon H; Touger, Michael

2008-11-01

Recurrent coagulopathy has been observed in patients after rattlesnake envenomation treated with Crotalidae Polyvalent Immune Fab (ovine) [FabAV]. While recurrent coagulopathy is well documented in the literature, clinically significant sequelae have not been reported. We present a case of recurrent thrombocytopenia after western diamondback envenomation treated with FabAV, resulting in an extensive recurrent local hemorrhage. A 24-year-old male presented to our emergency department several hours after western diamondback envenomation. He sustained bites to both hands and the right flank by leaning over his pet "snake enclosure." On presentation, the patient was hypotensive, tachycardic, and thrombocytopenic with a platelet count of 17/nl. Antivenom therapy was initiated according to the standard FabAV protocol. However, sixteen hours after completion of the recommended FabAV infusion, the patient experienced a recurrent thrombocytopenia with a dramatic seventeen point drop in hematocrit. The source of bleeding was clinically attributed to an expanding hematoma at the site of envenomation. FabAV has become the standard treatment for symptomatic crotalid envenomation. However, the pharmacokinetics of this drug predispose it to recurrent coagulopathies. While studies have shown persistent and recurrent coagulopathic derangements after FabAV therapy, no clinically significant sequelae have been reported. This report highlights the potential for recurrent local hemorrhagic complications following rattlesnake envenomation, even after treatment guided by the current FabAV protocol. Recurrent coagulopathy following FabAV therapy can result in clinically significant hemorrhage, supporting the observation that extended repeat dosing may be necessary to adequately treat subjects of rattlesnake envenomation.

Retrospective analysis of 119 cases of pediatric acute promyelocytic leukemia: Comparisons of four treatment regimes

PubMed Central

LI, EN-QIN; XU, LING; ZHANG, ZHI-QUAN; XIAO, YAN; GUO, HAI-XIA; LUO, XUE-QUN; HU, QUN; LAI, DONG-BO; TU, LI-MING; JIN, RUN-MING

2012-01-01

Clinical trials have demonstrated that pediatric acute promyelocytic leukemia (APL) is highly curable. Small-scale studies have reported on the treatment of APL using one or two treatment regimes. Here, we report a multiple center-based study of 119 cases of pediatric APL treated with four regimes based on all-trans-retinoic acid (ATRA). We retrospectively analyzed the clinical characteristics, laboratorial test results and treatment outcome of the pediatric APL patients. Regime 1 used an in-house developed protocol, regime 2 was modified from the PETHEMA LPA99 protocol, regime 3 was modified from the European-APL93 protocol, and regime 4 used a protocol suggested by the British Committee for Standards in Haematology. The overall complete remission rates for the four regimes were 88.9, 87.5, 97.1 and 87.5%, respectively, which exhibited no statistical difference. However, more favorable results were observed for regimes 2 and 3 than regimes 1 and 4, in terms of the estimated 3.5-year disease-free survivals, relapse rates, drug toxicity (including hepatotoxicity, cardiac arrhythmia, and differentiation syndrome) and sepsis. In conclusion, the overall outcomes were more favorable after treatment with regimes 2 and 3 than with regimes 1 and 4, and this may have been due to the specific compositions of regimes 2 and 3. PMID:23060929

Reporting of methods was better in the Clinical Trials Registry-India than in Indian journal publications.

PubMed

Tharyan, Prathap; George, Aneesh Thomas; Kirubakaran, Richard; Barnabas, Jabez Paul

2013-01-01

We sought to evaluate if editorial policies and the reporting quality of randomized controlled trials (RCTs) had improved since our 2004-05 survey of 151 RCTs in 65 Indian journals, and to compare reporting quality of protocols in the Clinical Trials Registry-India (CTRI). An observational study of endorsement of Consolidated Standards for the Reporting of Trials (CONSORT) and International Committee of Medical Journal Editors (ICMJE) requirements in the instructions to authors in Indian journals, and compliance with selected requirements in all RCTs published during 2007-08 vs. our previous survey and between all RCT protocols in the CTRI on August 31, 2010 and published RCTs from both surveys. Journal policies endorsing the CONSORT statement (22/67, 33%) and ICMJE requirements (35/67, 52%) remained suboptimal, and only 4 of 13 CONSORT items were reported in more than 50% of the 145 RCTs assessed. Reporting of ethical issues had improved significantly, and that of methods addressing internal validity had not improved. Adequate methods were reported significantly more frequently in 768 protocols in the CTRI, than in the 296 published trials. The CTRI template facilitates the reporting of valid methods in registered trial protocols. The suboptimal compliance with CONSORT and ICMJE requirements in RCTs published in Indian journals reduces credibility in the reliability of their results. Copyright © 2013 Elsevier Inc. All rights reserved.

Multicenter evaluation of stress-first myocardial perfusion image triage by nuclear technologists and automated quantification

PubMed Central

Chaudhry, Waseem; Hussain, Nasir; Ahlberg, Alan W.; Croft, Lori B.; Fernandez, Antonio B.; Parker, Mathew W.; Swales, Heather H.; Slomka, Piotr J.; Henzlova, Milena J.; Duvall, W. Lane

2016-01-01

Background A stress-first myocardial perfusion imaging (MPI) protocol saves time, is cost effective, and decreases radiation exposure. A limitation of this protocol is the requirement for physician review of the stress images to determine the need for rest images. This hurdle could be eliminated if an experienced technologist and/or automated computer quantification could make this determination. Methods Images from consecutive patients who were undergoing a stress-first MPI with attenuation correction at two tertiary care medical centers were prospectively reviewed independently by a technologist and cardiologist blinded to clinical and stress test data. Their decision on the need for rest imaging along with automated computer quantification of perfusion results was compared with the clinical reference standard of an assessment of perfusion images by a board-certified nuclear cardiologist that included clinical and stress test data. Results A total of 250 patients (mean age 61 years and 55% female) who underwent a stress-first MPI were studied. According to the clinical reference standard, 42 (16.8%) and 208 (83.2%) stress-first images were interpreted as “needing” and “not needing” rest images, respectively. The technologists correctly classified 229 (91.6%) stress-first images as either “needing” (n = 28) or “not needing” (n = 201) rest images. Their sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) were 66.7%, 96.6%, 80.0%, and 93.5%, respectively. An automated stress TPD score ≥1.2 was associated with optimal sensitivity and specificity and correctly classified 179 (71.6%) stress-first images as either “needing” (n = 31) or “not needing” (n = 148) rest images. Its sensitivity, specificity, PPV, and NPV were 73.8%, 71.2%, 34.1%, and 93.1%, respectively. In a model whereby the computer or technologist could correct for the other's incorrect classification, 242 (96.8%) stress-first images were correctly classified. The composite sensitivity, specificity, PPV, and NPV were 83.3%, 99.5%, 97.2%, and 96.7%, respectively. Conclusion Technologists and automated quantification software had a high degree of agreement with the clinical reference standard for determining the need for rest images in a stress-first imaging protocol. Utilizing an experienced technologist and automated systems to screen stress-first images could expand the use of stress-first MPI to sites where the cardiologist is not immediately available for interpretation. PMID:26566774

In vivo decontamination of the nerve agent VX using the domestic swine model.

PubMed

Misik, Jan; Pavlik, Michal; Novotny, Ladislav; Pavlikova, Ruzena; Chilcott, Robert P; Cabal, Jiri; Kuca, Kamil

2012-11-01

The purpose of this in vivo study was to assess a new, putatively optimised method for mass casualty decontamination ("ORCHIDS protocol") for effectiveness in removing the chemical warfare agent VX from the skin of anaesthetised, domestic white pigs. ORCHIDS protocol consists of a 1.5-minute shower with a mild detergent (Argos™) supplemented by physical removal. A standard method of wet decontamination was used for comparison. Experimental animals were divided into four groups (A-D). Two groups were exposed to a supra-lethal percutaneous dose (5 × LD(50); 300 μg kg(-1)) of VX for 1 h prior to decontamination with either the ORCHIDS (C) or standard protocol (D). A third (B, positive control) group was exposed but not subject to decontamination. Blank controls (A) received anaesthesia and the corresponding dose of normal saline instead of VX. Observations of the clinical signs of intoxication were supplemented by measurements of whole blood cholinesterase (ChE) performed on samples of arterial blood acquired at 30-minute intervals for the duration of the study (up to 6 h). Untreated (B) animals displayed typical cholinergic signs consistent with VX intoxication (local fasciculation, mastication, salivation, pilo-erection and motor convulsions) and died 165-240 min post exposure. All animals in both decontamination treatment groups (C, D) survived the duration of the study and exhibited less severe signs of cholinergic poisoning. Thus, both the standard and ORCHIDS protocol were demonstrably effective against exposure to the potent nerve agent VX, even after a delay of 1 h. A critical advantage of the ORCHIDS protocol is the relatively short shower duration (1½ min compared to 3 min). In practice, this could substantially improve the rate at which individuals could be decontaminated by emergency responders following exposure to toxic materials such as chemical warfare agents.

Comparison of cyclophosphamide-thalidomide-dexamethasone to bortezomib-cyclophosphamide-dexamethasone as induction therapy for multiple myeloma patients in Brazil.

PubMed

Vigolo, Suelen; Zuckermann, Joice; Bittencourt, Rosane Isabel; Silla, Lúcia; Pilger, Diogo André

2017-09-01

Chemotherapy followed by autologous hematopoietic stem cell transplantation (HSCT) remains the standard treatment for multiple myeloma (MM). Thalidomide or bortezomib may be combined with cyclophosphamide and dexamethasone, in what are known as the CTD and VCD protocols, respectively. The objective of this study was to evaluate the clinical characteristics and response rates obtained with CTD and VCD, observing whether the inclusion of bortezomib to treat MM patients in Brazil increases therapeutic efficiency. Forty-three MM patients treated with induction protocols CTD and VCD between January 2010 and March 2015 were included. The parameters analyzed were staging, frequency of comorbidities prior to treatment, response rates obtained at each induction cycle, progression-free survival, and overall survival of patients. Very good partial response and complete response obtained with the VCD protocol were superior, compared with the CTD treatment. The presence of comorbidities was similar in the two groups, except kidney failure, which prevailed in the VCD group. Also, 78.3% and 48.3% of patients treated with the VCD and CTD protocols underwent autologous HSCT, respectively. In patients given the VCD protocol, 45.5% had complete response before autologous HSCT. Among those given CTD, this number was only 7.1% (p=0.023). Disease progression after autologous HSCT did not differ between the two groups. VCD afforded better responses than the CTD protocol, and improved patient condition before autologous HSCT. However, more studies are necessary including more patients and addressing various clinical conditions, besides the analysis of cost-effectiveness of these treatments. Copyright © 2017 King Faisal Specialist Hospital & Research Centre. Published by Elsevier B.V. All rights reserved.

Management of persistent postconcussion symptoms in youth: a randomised control trial protocol

PubMed Central

Reed, Nick; Greenspoon, Dayna; Iverson, Grant L; DeMatteo, Carol; Fait, Philippe; Gauvin-Lepage, Jérôme; Hunt, Anne; Gagnon, Isabelle J

2015-01-01

Introduction Current management of concussion consists of early education, rest until symptom free, with gradual return to school and physical activity protocols. Although this management strategy is effective for most youth who sustain a concussion, it is not an appropriate strategy for youth with persistent postconcussion symptoms. Prolonged rest and periods of restricted activity may place youth at risk for secondary issues and contribute to the chronicity of postconcussion symptoms. The purpose of this study is to evaluate the efficacy of an active rehabilitation protocol for youth who are slow to recover from concussion. It is hypothesised that an active rehabilitation intervention can reduce persistent postconcussion symptoms, improve function and facilitate return to activity. This article describes the research protocol. Methods and analysis This is a randomised clinical trial with blinded outcome measurement. Participants will be recruited and randomly assigned to 1 of 2 treatment groups, an active rehabilitation intervention or a standard care education group. Both groups will receive standard care education. However, the active rehabilitation group will participate in an additional low-intensity exercise programme consisting of aerobic, coordination and visualisation exercises. Both the active rehabilitation and the standard care education interventions will be 6 weeks in duration. The primary outcome measure is postconcussion symptoms. Secondary outcome measures include functional recovery (cognitive, motor, psychosocial and emotional functioning) and return to activity. Outcome measures will be administered preintervention and postintervention. The primary outcome measure will also be repeated 2 weeks into the intervention period. Ethics and dissemination This study has been approved by the Holland Bloorview Kids Rehabilitation Hospital research ethics board (REB # 13-459). The findings from this study will be shared with the general public, sport associations, relevant brain injury organisations and healthcare professionals. Trial registration number NCT02257749. PMID:26231756

Developing a Clinical-Grade Cryopreservation Protocol for Human Testicular Tissue and Cells

PubMed Central

Pacchiarotti, Jason; Ramos, Thomas; Howerton, Kyle; Greilach, Scott; Zaragoza, Karina; Olmstead, Marnie; Izadyar, Fariborz

2013-01-01

Recent work in preservation of female fertility as well as new information on the nature of spermatogonial stem cells has prompted an investigation into the possibility of an effective clinical-grade procedure for the cryopreservation of testicular cells and/or tissue. Clinical-grade reagents, validated equipment, and protocols consistent with cGTP/cGMP standards were used in developing a procedure suitable for the safe and effective cryopreservation of human testicular cells and tissues. These procedures were designed to be compliant with the relevant FDA regulations. The procedure proved to effectively cryopreserve both testicular cells and tissue. The cryopreservation of testicular tissue was comparable in most aspects we measured to the cryopreservation of isolated cells, except that the viability of the cells from cryopreserved testicular tissue was found to be significantly higher. On the other hand, cryopreservation of cells is preferred for cell analysis, quality control, and sterility testing. This study demonstrates that testicular tissue and cells from sexual reassignment patients can be successfully cryopreserved with a clinical-grade procedure and important cell populations are not only preserved but also enriched by the process. Further studies will determine whether these findings from hormone-treated patients can be generalized to other patients. PMID:23509810

Technical pre-analytical effects on the clinical biochemistry of Atlantic salmon (Salmo salar L.).

PubMed

Braceland, M; Houston, K; Ashby, A; Matthews, C; Haining, H; Rodger, H; Eckersall, P D

2017-01-01

Clinical biochemistry has long been utilized in human and veterinary medicine as a vital diagnostic tool, but despite occasional studies showing its usefulness in monitoring health status in Atlantic salmon (Salmo salar L.), it has not yet been widely utilized within the aquaculture industry. This is due, in part, to a lack of an agreed protocol for collection and processing of blood prior to analysis. Moreover, while the analytical phase of clinical biochemistry is well controlled, there is a growing understanding that technical pre-analytical variables can influence analyte concentrations or activities. In addition, post-analytical interpretation of treatment effects is variable in the literature, thus making the true effect of sample treatment hard to evaluate. Therefore, a number of pre-analytical treatments have been investigated to examine their effect on analyte concentrations and activities. In addition, reference ranges for salmon plasma biochemical analytes have been established to inform veterinary practitioners and the aquaculture industry of the importance of clinical biochemistry in health and disease monitoring. Furthermore, a standardized protocol for blood collection has been proposed. © 2016 The Authors Journal of Fish Diseases Published by John Wiley & Sons Ltd.

[Treatment results with ALL-BFM-95 protocol in children with acute lymphoblastic leukemia in Hungary].

PubMed

Müller, Judit; Kovács, Gábor; Jakab, Zsuzsanna; Rényi, Imre; Galántai, Ilona; Békési, Andrea; Kiss, Csongor; Nagy, Kálmán; Kajtár, Pál; Bartyik, Katalin; Masát, Péter; Magyarosy, Edina

2005-01-09

In Hungary children (from 1 to 18 years of age) with de novo acute lymphoblastic leukemia were treated from January 1996 to October 2002, according to protocol ALL-BFM-95. The aim of this study was to evaluate the experience with this protocol, the treatment results according to the risk groups and to compare the Hungarian data with the international results. Patients were stratified into 3 risk groups, based on initial white blood cell count, age, immunology, cytogenetics and response to treatment: standard, medium and high risk group. Three hundred sixty eight children entered the study (male-female ratio was 1.27:1, median age 6 years and 4 months). 110 (29.9%) children were in the standard, 210 (57.1%) in the medium and 48 (13%) in the high risk group. Duration of the chemotherapy was 2 years, except of the boys in the standard risk group, their maintenance therapy was 1 year longer. The overall complete remission rate was 93.2%. 20 (5.4%) children died in induction and 5 (1.4%) were non-responders. The 5-year overall survival for all patients was 78.5%, in the standard risk group 93.2%, in the medium risk group 78.4% and in the high risk group 44.5% with a minimum follow up of 1.19 years and median follow up of 4.85 years. From the 368 patients 272 (73.9%) are still in their first complete clinical remission and other 18 children are alive after relapse. In 14.7% of the patients relapse was diagnosed; the most common site was the bone marrow. In one patient second malignancy occurred. The 5-year event free survival for all patients was 72.6%, in the standard risk group 87.6%, in the medium risk group 72.1% and in the high risk group 39.9%. The treatment outcome of children with acute lymphoblastic leukemia improved remarkably over the last decades. 78% of children suffering from acute lymphoblastic leukemia could be cured with the ALL-BFM-95 protocol. The Hungarian results are comparable to those achieved by other leukaemia study groups in the world regarding the ALL-BFM-95 protocol.

Evaluation of Protocol Uniformity Concerning Laparoscopic Cholecystectomy in The Netherlands

PubMed Central

Goossens, Richard H. M.; van Eijk, Daan J.; Lange, Johan F.

2008-01-01

Background Iatrogenic bile duct injury remains a current complication of laparoscopic cholecystectomy. One uniform and standardized protocol, based on the “critical view of safety” concept of Strasberg, should reduce the incidence of this complication. Furthermore, owing to the rapid development of minimally invasive surgery, technicians are becoming more frequently involved. To improve communication between the operating team and technicians, standardized actions should also be defined. The aim of this study was to compare existing protocols for laparoscopic cholecystectomy from various Dutch hospitals. Methods Fifteen Dutch hospitals were contacted for evaluation of their protocols for laparoscopic cholecystectomy. All evaluated protocols were divided into six steps and were compared accordingly. Results In total, 13 hospitals responded—5 academic hospitals, 5 teaching hospitals, 3 community hospitals—of which 10 protocols were usable for comparison. Concerning the trocar positions, only minor differences were found. The concept of “critical view of safety” was represented in just one protocol. Furthermore, the order of clipping and cutting the cystic artery and duct differed. Descriptions of instruments and apparatus were also inconsistent. Conclusions Present protocols differ too much to define a universal procedure among surgeons in The Netherlands. The authors propose one (inter)national standardized protocol, including standardized actions. This uniform standardized protocol has to be officially released and recommended by national scientific associations (e.g., the Dutch Society of Surgery) or international societies (e.g., European Association for Endoscopic Surgery and Society of American Gastrointestinal and Endoscopic Surgeons). The aim is to improve patient safety and professional communication, which are necessary for new developments. PMID:18224485

[Evaluating psychological injury in motor vehicle accidents (MVA): development and validation of a protocol for detecting pretense].

PubMed

Arce, Ramón; Fariña, Francisca; Carballal, Alicia; Novo, Mercedes

2006-05-01

In order to assess the feigning ability of the psychological injury in a motor vehicle accident (MVA), a total of 105 subjects, which never had suffered a serious MVA and lay in psychopathology, responded to the MMPI-2 in line with the standard instructions. Thereafter, subjects were instructed to feign moral damage generated by a MVA prior to being evaluated using a clinical-forensic interview a week later, and responding to the MMPI-2 another week later. The results show that 60.9% of the subjects were able to effectively feign moral damage on the MMPI-2, and 3.8% in the forensic clinical interview. The analysis of the instruments and procedures for the validation of subject responses i.e., the original validity control scales of the MMPI-2 and the analysis of feigning strategies in the forensic clinical interview, revealed no efficacy in feigning detection. Nevertheless, collectively, all the control measures and procedures were effective for the detection of feigning. Therefore, a protocol for the detection of feigning of moral damage has been proposed.

Clinical examination of subjects with halitosis.

PubMed

Donaldson, A C; Riggio, M P; Rolph, H J; Bagg, J; Hodge, P J

2007-01-01

To develop and apply a detailed clinical protocol for screening and assessing subjects with a complaint of halitosis. Cross-sectional. Several methods were used to recruit subjects with a complaint of halitosis, including a newspaper advertisement. A definition of halitosis arising from within the oral cavity, which is not related to generalized chronic gingivitis, chronic periodontitis or pathology of the oral mucosa was used. An extensive list of exclusion criteria was applied at the initial visit. Eligible subjects were asked to follow strict instructions and complete a questionnaire prior to their second visit for data collection. The clinical examination consisted of an organoleptic assessment, Halimeter reading and periodontal examination. The best method of recruiting subjects was advertising. Of 66 individuals recruited, four failed to attend the screening visit and 25 were excluded. The main reasons for exclusion were poor oral hygiene and existing periodontal disease. Thirty-seven completed the full protocol, resulting in identification of 18 with halitosis and 19 controls. Application of the exclusion criteria resulted in significant attrition of eligible participants. Our results suggest that organoleptic assessment should be regarded as a useful standard for defining subjects with halitosis.

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.

3.0 Tesla magnetic resonance imaging: A new standard in liver imaging?

PubMed Central

Girometti, Rossano

2015-01-01

An ever-increasing number of 3.0 Tesla (T) magnets are installed worldwide. Moving from the standard of 1.5 T to higher field strength implies a number of potential advantage and drawbacks, requiring careful optimization of imaging protocols or implementation of novel hardware components. Clinical practice and literature review suggest that state-of-the-art 3.0 T is equivalent to 1.5 T in the assessment of focal liver lesions and diffuse liver disease. Therefore, further technical improvements are needed in order to fully exploit the potential of higher field strength. PMID:26244063

3.0 Tesla magnetic resonance imaging: A new standard in liver imaging?

PubMed

Girometti, Rossano

2015-07-28

An ever-increasing number of 3.0 Tesla (T) magnets are installed worldwide. Moving from the standard of 1.5 T to higher field strength implies a number of potential advantage and drawbacks, requiring careful optimization of imaging protocols or implementation of novel hardware components. Clinical practice and literature review suggest that state-of-the-art 3.0 T is equivalent to 1.5 T in the assessment of focal liver lesions and diffuse liver disease. Therefore, further technical improvements are needed in order to fully exploit the potential of higher field strength.

Optimized human platelet lysate as novel basis for a serum-, xeno-, and additive-free corneal endothelial cell and tissue culture.

PubMed

Thieme, Daniel; Reuland, Lynn; Lindl, Toni; Kruse, Friedrich; Fuchsluger, Thomas

2018-02-01

The expansion of donor-derived corneal endothelial cells (ECs) is a promising approach for regenerative therapies in corneal diseases. To achieve the best Good Manufacturing Practice standard the entire cultivation process should be devoid of nonhuman components. However, so far, there is no suitable xeno-free protocol for clinical applications. We therefore introduce a processed variant of a platelet lysate for the use in corneal cell and tissue culture based on a Good Manufacturing Practice-grade thrombocyte concentrate. This processed human platelet lysate (phPL), free of any animal components and of anticoagulants such as heparin with a physiological ionic composition, was used to cultivate corneal ECs in vitro and ex vivo in comparison to standard cultivation with fetal calf serum (FCS). Human donor corneas were cut in quarters while 2 quarters of each cornea were incubated with the respective medium supplement. Three fields of view per quarter were taken into account for the analysis. Evaluation of phPL as a medium supplement in cell culture of immortalized EC showed a superior viability compared with FCS control with reduced cell proliferation. Furthermore, the viability during the expansion of primary cells is significantly (3-fold ±0.5) increased with phPL compared with FCS standard medium. Quartering donor corneas was traumatic for the endothelium and therefore resulted in increased EC loss. Interestingly, however, cultivation of the quartered pieces for 2 weeks in 0.1-mg/ml pHPL in Biochrome I showed a 21 (±10) % EC loss compared with 67 (±12) % EC loss when cultivated in 2% FCS in Biochrome I. The cell culture protocol with pHPL as FCS replacement seems to be superior to the standard FCS protocols with respect to EC survival. It offers a xeno-free and physiological environment for corneal endothelial cells. This alternative cultivation protocol could facilitate the use of EC for human corneal cell therapy. Copyright © 2017 John Wiley & Sons, Ltd.

Quality assurance guides health reform in Jordan.

PubMed

Abubaker, W; Abdulrahman, M

1996-01-01

In November 1995, a World Bank mission went to Jordan to conduct a study of the health sector. The study recommended three strategies to reform the health sector: decentralization of Ministry of Health (MOH) management; improvement of clinical practices, quality of care, and consumer satisfaction; and adoption of treatment protocols and standards. The MOH chose quality assurance (QA) methods and quality management (QM) techniques to accomplish these reforms. The Monitoring and QA Directorate oversees QA applications within MOH. It also institutes and develops the capacity of local QA units in the 12 governorates. The QA units implement and monitor day-to-day QA activities. The QM approach encompasses quality principles: establish objectives; use a systematic approach; teach lessons learned and applicable research; use QA training to teach quality care, quality improvement, and patient satisfaction; educate health personnel about QM approaches; use assessment tools and interviews; measure the needs and expectations of local health providers and patients; ensure feedback on QA improvement projects; ensure valid and reliable data; monitor quality improvement efforts; standardize systemic data collection and outcomes; and establish and disseminate QA standards and performance improvement efforts. The Jordan QA Project has helped with the successful institutionalization of a QA system at both the central and local levels. The bylaws of the QA councils and committees require team participation in the decision-making process. Over the last two years, the M&QA Project has adopted 21 standards for nursing, maternal and child health care centers, pharmacies, and medications. The Balqa pilot project has developed 44 such protocols. Quality improvement (COUGH) studies have examined hyper-allergy, analysis of patient flow rate, redistribution of nurses, vaccine waste, and anemic pregnant women. There are a considerable number of on-going clinical and non-clinical COUGH studies. Four epidemiological studies are examining maternal mortality, causes of death, morbidity, and perinatal mortality.

Telemetry Standards, RCC Standard 106-17. Chapter 21. Telemetry Network Standard Introduction

DTIC Science & Technology

2017-07-01

Critical RF radio frequency RFC Request for Comment SNMP Simple Network Management Protocol TA test article TCP Transmission Control Protocol...chapters might be of most interest for a particular reader. In order to guide the reader toward the chapters of further interest , the applicable... Simple Network Management Protocol (SNMP) to pass management information through the system. The SNMP management information bases (MIBs) provide

Prospective Use of a Standardized Nonoperative Early Weightbearing Protocol for Achilles Tendon Rupture: 17 Years of Experience.

PubMed

Ecker, Timo M; Bremer, Anne K; Krause, Fabian G; Müller, Thorsten; Weber, Martin

2016-04-01

Acute traumatic rupture of the Achilles tendon can be treated operatively or nonoperatively. Throughout the literature, there is no consensus regarding the optimal treatment protocol. To report on 17 years of experience with treating this injury with a standardized nonoperative treatment protocol. Case Series; Level of evidence, 4. The treatment protocol was based on a combination of an equinus cast and rehabilitation boot, which promoted immediate full weightbearing and early functional rehabilitation. A total of 171 patients were consecutively treated and prospectively followed from 1996 to 2013. Assessed were subjective parameters such as pain, loss of strength, return to previous activity level, meteosensitivity, and general satisfaction with the treatment outcome. Clinical assessment included testing of plantar flexion strength and endurance, calf circumference, and tendon length. Subjective and clinical parameters were then used to calculate a modified Thermann score. The correlation between tendon lengthening and function was calculated using the Pearson correlation coefficient. A total of 114 patients were followed for a minimum of 12 months (mean, 27 ± 20 months; range, 12-88 months). The mean Thermann score was 82 ± 13 (range, 41-100), and subjective satisfaction was rated "very good" and "good" in 90%. An inverse correlation was found between tendon length and muscle strength (R = -0.3). There were 11 reruptures (8 with and 3 without an adequate trauma). General complications were 5 deep venous thromboses, 1 complex regional pain syndrome, and minor problems such as transient heel pain (n = 3), heel numbness (n = 1), and cast-associated skin abrasions (n = 4). Seventeen years of experience with a nonoperative treatment protocol for acute rupture of the Achilles tendon confirmed good functional outcome and patient satisfaction. Reruptures mostly occurred with new traumatic events in the vulnerable phase from 6 to 12 weeks after the initial injury. Muscle strength correlated to tendon length, making its assessment a crucial follow-up parameter. The protective equinus cast and boot can protect against excessive tendon lengthening during the healing process. © 2016 The Author(s).

An Improved In-house MALDI-TOF MS Protocol for Direct Cost-Effective Identification of Pathogens from Blood Cultures.

PubMed

Zhou, Menglan; Yang, Qiwen; Kudinha, Timothy; Sun, Liying; Zhang, Rui; Liu, Chang; Yu, Shuying; Xiao, Meng; Kong, Fanrong; Zhao, Yupei; Xu, Ying-Chun

2017-01-01

Background: Bloodstream infection is a major cause of morbidity and mortality in hospitalized patients worldwide. Delays in the identification of microorganisms often leads to a poor prognosis. The application of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry (MALDI-TOF MS) directly to blood culture (BC) broth can potentially identify bloodstream infections earlier, and facilitate timely management. Methods: We developed an "in-house" (IH) protocol for direct MALDI-TOF MS based identification of organisms in positive BCs. The IH protocol was initially evaluated and improved with spiked BC samples, and its performance was compared with the commercial Sepsityper™ kit using both traditional and modified cut-off values. We then studied in parallel the performance of the IH protocol and the colony MS identifications in positive clinical BC samples using only modified cut-off values. All discrepancies were investigated by "gold standard" of gene sequencing. Results: In 54 spiked BC samples, the IH method showed comparable results with Sepsityper™ after applying modified cut-off values. Specifically, accurate species and genus level identification was achieved in 88.7 and 3.9% of all the clinical monomicrobial BCs (284/301, 94.4%), respectively. The IH protocol exhibited superior performance for Gram negative bacteria than for Gram positive bacteria (92.8 vs. 82.4%). For anaerobes and yeasts, accurate species identification was achieved in 80.0 and 90.0% of the cases, respectively. For polymicrobial cultures (17/301, 5.6%), MALDI-TOF MS correctly identified a single species present in all the polymicrobial BCs under the Standard mode, while using the MIXED method, two species were correctly identified in 52.9% of the samples. Comparisons based on BC bottle type, showed that the BACTEC™ Lytic/10 Anaerobic/F culture vials performed the best. Conclusion: Our study provides a novel and effective sample preparation method for MALDI-TOF MS direct identification of pathogens from positive BC vials, with a lower cost ($1.5 vs. $ 7) albeit a slightly more laborious extracting process (an extra 15 min) compared with Sepsityper™ kit.

Refining animal models in fracture research: seeking consensus in optimising both animal welfare and scientific validity for appropriate biomedical use.

PubMed

Auer, Jorg A; Goodship, Allen; Arnoczky, Steven; Pearce, Simon; Price, Jill; Claes, Lutz; von Rechenberg, Brigitte; Hofmann-Amtenbrinck, Margarethe; Schneider, Erich; Müller-Terpitz, R; Thiele, F; Rippe, Klaus-Peter; Grainger, David W

2007-08-01

In an attempt to establish some consensus on the proper use and design of experimental animal models in musculoskeletal research, AOVET (the veterinary specialty group of the AO Foundation) in concert with the AO Research Institute (ARI), and the European Academy for the Study of Scientific and Technological Advance, convened a group of musculoskeletal researchers, veterinarians, legal experts, and ethicists to discuss, in a frank and open forum, the use of animals in musculoskeletal research. The group narrowed the field to fracture research. The consensus opinion resulting from this workshop can be summarized as follows: Anaesthesia and pain management protocols for research animals should follow standard protocols applied in clinical work for the species involved. This will improve morbidity and mortality outcomes. A database should be established to facilitate selection of anaesthesia and pain management protocols for specific experimental surgical procedures and adopted as an International Standard (IS) according to animal species selected. A list of 10 golden rules and requirements for conduction of animal experiments in musculoskeletal research was drawn up comprising 1) Intelligent study designs to receive appropriate answers; 2) Minimal complication rates (5 to max. 10%); 3) Defined end-points for both welfare and scientific outputs analogous to quality assessment (QA) audit of protocols in GLP studies; 4) Sufficient details for materials and methods applied; 5) Potentially confounding variables (genetic background, seasonal, hormonal, size, histological, and biomechanical differences); 6) Post-operative management with emphasis on analgesia and follow-up examinations; 7) Study protocols to satisfy criteria established for a "justified animal study"; 8) Surgical expertise to conduct surgery on animals; 9) Pilot studies as a critical part of model validation and powering of the definitive study design; 10) Criteria for funding agencies to include requirements related to animal experiments as part of the overall scientific proposal review protocols. Such agencies are also encouraged to seriously consider and adopt the recommendations described here when awarding funds for specific projects. Specific new requirements and mandates related both to improving the welfare and scientific rigour of animal-based research models are urgently needed as part of international harmonization of standards.

TU-G-BRD-04: A Round Robin Dosimetry Intercomparison of Gamma Stereotactic Radiosurgery Calibration Protocols

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

Drzymala, R; Alvarez, P; Bednarz, G

2015-06-15

Purpose: The purpose of this multi-institutional study was to compare two new gamma stereotactic radiosurgery (GSRS) dosimetry protocols to existing calibration methods. The ultimate goal was to guide AAPM Task Group 178 in recommending a standard GSRS dosimetry protocol. Methods: Nine centers (ten GSRS units) participated in the study. Each institution made eight sets of dose rate measurements: six with two different ionization chambers in three different 160mm-diameter spherical phantoms (ABS plastic, Solid Water and liquid water), and two using the same ionization chambers with a custom in-air positioning jig. Absolute dose rates were calculated using a newly proposed formalismmore » by the IAEA working group for small and non-standard radiation fields and with a new air-kerma based protocol. The new IAEA protocol requires an in-water ionization chamber calibration and uses previously reported Monte-Carlo generated factors to account for the material composition of the phantom, the type of ionization chamber, and the unique GSRS beam configuration. Results obtained with the new dose calibration protocols were compared to dose rates determined by the AAPM TG-21 and TG-51 protocols, with TG-21 considered as the standard. Results: Averaged over all institutions, ionization chambers and phantoms, the mean dose rate determined with the new IAEA protocol relative to that determined with TG-21 in the ABS phantom was 1.000 with a standard deviation of 0.008. For TG-51, the average ratio was 0.991 with a standard deviation of 0.013, and for the new in-air formalism it was 1.008 with a standard deviation of 0.012. Conclusion: Average results with both of the new protocols agreed with TG-21 to within one standard deviation. TG-51, which does not take into account the unique GSRS beam configuration or phantom material, was not expected to perform as well as the new protocols. The new IAEA protocol showed remarkably good agreement with TG-21. Conflict of Interests: Paula Petti, Josef Novotny, Gennady Neyman and Steve Goetsch are consultants for Elekta Instrument A/B; Elekta Instrument AB, PTW Freiburg GmbH, Standard Imaging, Inc., and The Phantom Laboratory, Inc. loaned equipment for use in these experiments; The University of Wisconsin Accredited Dosimetry Calibration Laboratory provided calibration services.« less

A Standard Mutual Authentication Protocol for Cloud Computing Based Health Care System.

PubMed

Mohit, Prerna; Amin, Ruhul; Karati, Arijit; Biswas, G P; Khan, Muhammad Khurram

2017-04-01

Telecare Medical Information System (TMIS) supports a standard platform to the patient for getting necessary medical treatment from the doctor(s) via Internet communication. Security protection is important for medical records (data) of the patients because of very sensitive information. Besides, patient anonymity is another most important property, which must be protected. Most recently, Chiou et al. suggested an authentication protocol for TMIS by utilizing the concept of cloud environment. They claimed that their protocol is patient anonymous and well security protected. We reviewed their protocol and found that it is completely insecure against patient anonymity. Further, the same protocol is not protected against mobile device stolen attack. In order to improve security level and complexity, we design a light weight authentication protocol for the same environment. Our security analysis ensures resilience of all possible security attacks. The performance of our protocol is relatively standard in comparison with the related previous research.

A contaminant-free assessment of Endogenous Retroviral RNA in human plasma

PubMed Central

Karamitros, Timokratis; Paraskevis, Dimitrios; Hatzakis, Angelos; Psichogiou, Mina; Elefsiniotis, Ioannis; Hurst, Tara; Geretti, Anna-Maria; Beloukas, Apostolos; Frater, John; Klenerman, Paul; Katzourakis, Aris; Magiorkinis, Gkikas

2016-01-01

Endogenous retroviruses (ERVs) comprise 6–8% of the human genome. HERVs are silenced in most normal tissues, up-regulated in stem cells and in placenta but also in cancer and HIV-1 infection. Crucially, there are conflicting reports on detecting HERV RNA in non-cellular clinical samples such as plasma that suggest the study of HERV RNA can be daunting. Indeed, we find that the use of real-time PCR in a quality assured clinical laboratory setting can be sensitive to low-level proviral contamination. We developed a mathematical model for low-level contamination that allowed us to design a laboratory protocol and standard operating procedures for robust measurement of HERV RNA. We focus on one family, HERV-K HML-2 (HK2) that has been most recently active even though they invaded our ancestral genomes almost 30 millions ago. We extensively validated our experimental design on a model cell culture system showing high sensitivity and specificity, totally eliminating the proviral contamination. We then tested 236 plasma samples from patients infected with HIV-1, HCV or HBV and found them to be negative. The study of HERV RNA for human translational studies should be performed with extensively validated protocols and standard operating procedures to control the widespread low-level human DNA contamination. PMID:27640347

EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards

EPA Science Inventory

In 1997, the U.S. Environmental Protection Agency (EPA) in Research Triangle Park, North Carolina, revised its 1993 version of its traceability protocol for the assay and certification of compressed gas and permeation-device calibration standards. The protocol allows producers o...

Effects of anesthetic protocol on normal canine brain uptake of 18F-FDG assessed by PET/CT.

PubMed

Lee, Min Su; Ko, Jeff; Lee, Ah Ra; Lee, In Hye; Jung, Mi Ae; Austin, Brenda; Chung, Hyunwoo; Nahm, Sangsoep; Eom, Kidong

2010-01-01

The purpose of this study was to assess the effects of four anesthetic protocols on normal canine brain uptake of 2-deoxy-2-[18F]fluoro-D-glucose (FDG) using positron emission tomography/computed tomography (PET/CT). Five clinically normal beagle dogs were anesthetized with (1) propofol/isoflurane, (2) medetomidine/pentobarbital, (3) xylazine/ketamine, and (4) medetomidine/tiletamine-zolazepam in a randomized cross-over design. The standard uptake value (SUV) of FDG was obtained in the frontal, parietal, temporal and occipital lobes, cerebellum, brainstem and whole brain, and compared within and between anesthetic protocols using the Friedman test with significance set at P < 0.05. Significant differences in SUVs were observed in various part of the brain associated with each anesthetic protocol. The SUV for the frontal and occipital lobes was significantly higher than in the brainstem in all dogs. Dogs receiving medetomidine/tiletamine-zolazepam also had significantly higher whole brain SUVs than the propofol/isoflurane group. We concluded that each anesthetic protocol exerted a different regional brain glucose uptake pattern. As a result, when comparing brain glucose uptake using PET/CT, one should consider the effects of anesthetic protocols on different regions of the glucose uptake in the dog's brain.

Performance of fast-setting impression materials in the reproduction of subgingival tooth surfaces without soft tissue retraction.

PubMed

Rudolph, Heike; Röhl, Andreas; Walter, Michael H; Luthardt, Ralph G; Quaas, Sebastian

2014-01-01

Fast-setting impression materials may be prone to inaccuracies due to accidental divergence from the recommended mixing protocol. This prospective randomized clinical trial aimed to assess three-dimensional (3D) deviations in the reproduction of subgingival tooth surfaces and to determine the effect of either following or purposely diverging from the recommended mixing procedure for a fast-setting addition-curing silicone (AS) and fast-setting polyether (PE). After three impressions each were taken from 96 participants, sawcut gypsum casts were fabricated with a standardized procedure and then optically digitized. Data were assessed with a computer-aided 3D analysis. For AS impressions, multivariate analysis of variance revealed a significant influence of the individual tooth and the degree to which the recommended mixing protocol was violated. For PE impressions, the ambient air temperature and individual tooth showed significant effects, while divergence from the recommended mixing protocol was not of significance. The fast-setting PE material was not affected by changes in the recommended mixing protocol. For the two fast-setting materials examined, no divergences from the recommended mixing protocol of less than 2 minutes led to failures in the reproduction of the subgingival tooth surfaces.

Validation protocols for blood pressure-measuring devices: status quo and development needs.

PubMed

Beime, Beate; Deutsch, Cornelia; Gomez, Timothy; Zwingers, Thomas; Mengden, Thomas; Bramlage, Peter

2016-02-01

Hypertension is a major risk factor for cardiovascular morbidity and mortality. Therefore, blood pressure self-measuring devices have emerged as valuable tools in patient care and the accuracy of these instruments is of fundamental importance. For this reason, several validation procedures for assessing the efficacy of blood pressure monitoring devices have been developed, including protocols by the Association for the Advancement of Medical Instrumentation, the British Hypertension Society, the German Hypertension League (Prüfsiegelprotokoll), and the International Protocol of the Working Group on Blood Pressure Monitoring of the European Society of Hypertension. In the past, most of the protocols have been reviewed and modified because of experiences gained during the validation studies carried out. However, each shows distinct differences, that is number and characteristics of patients required, blood pressure ranges, and the length of the validation procedure, which may result in unique advantages and/or limitations associated with their use. The continued standardization and evolution of these guidelines is essential to ensure the efficacy of blood pressure-measuring devices marketed for clinical and home use. Here, we aimed to compare four currently used validation protocols and to initiate a discussion on potential future improvements.

Comparison of the recommendations of the AAPM TG-51 and TG-51 addendum reference dosimetry protocols.

PubMed

McCaw, Travis J; Hwang, Min-Sig; Jang, Si Young; Huq, M Saiful

2017-07-01

This work quantified differences between recommendations of the TG-51 and TG-51 addendum reference dosimetry protocols. Reference dosimetry was performed for flattened photon beams with nominal energies of 6, 10, 15, and 23 MV, as well as flattening-filter free (FFF) beam energies of 6 and 10 MV, following the recommendations of both the TG-51 and TG-51 addendum protocols using both a Farmer ® ionization chamber and a scanning ionization chamber with calibration coefficients traceable to absorbed dose-to-water (D w ) standards. Differences in D w determined by the two protocols were 0.1%-0.3% for beam energies with a flattening filter, and up to 0.2% and 0.8% for FFF beams measured with the scanning and Farmer ® ionization chambers, respectively, due to k Q determination, volume-averaging correction, and collimator jaw setting. Combined uncertainty was between 0.91% and 1.2% (k = 1), varying by protocol and detector. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

16S rRNA Gene Sequencing for Deciphering the Colorectal Cancer Gut Microbiome: Current Protocols and Workflows.

PubMed

Osman, Muhammad-Afiq; Neoh, Hui-Min; Ab Mutalib, Nurul-Syakima; Chin, Siok-Fong; Jamal, Rahman

2018-01-01

The human gut holds the densest microbiome ecosystem essential in maintaining a healthy host physiology, whereby disruption of this ecosystem has been linked to the development of colorectal cancer (CRC). The advent of next-generation sequencing technologies such as the 16S rRNA gene sequencing has enabled characterization of the CRC gut microbiome architecture in an affordable and culture-free approach. Nevertheless, the lack of standardization in handling and storage of biospecimens, nucleic acid extraction, 16S rRNA gene primer selection, length, and depth of sequencing and bioinformatics analyses have contributed to discrepancies found in various published studies of this field. Accurate characterization of the CRC microbiome found in different stages of CRC has the potential to be developed into a screening tool in the clinical setting. This mini review aims to concisely compile all available CRC microbiome studies performed till end of 2016 and to suggest standardized protocols that are crucial in developing a gut microbiome screening panel for CRC.

TH-E-209-00: Radiation Dose Monitoring and Protocol Management

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

NONE

Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilitiesmore » over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.« less

TH-E-209-02: Dose Monitoring and Protocol Optimization: The Pediatric Perspective

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

MacDougall, R.

Radiation dose monitoring solutions have opened up new opportunities for medical physicists to be more involved in modern clinical radiology practices. In particular, with the help of comprehensive radiation dose data, data-driven protocol management and informed case follow up are now feasible. Significant challenges remain however and the problems faced by medical physicists are highly heterogeneous. Imaging systems from multiple vendors and a wide range of vintages co-exist in the same department and employ data communication protocols that are not fully standardized or implemented making harmonization complex. Many different solutions for radiation dose monitoring have been implemented by imaging facilitiesmore » over the past few years. Such systems are based on commercial software, home-grown IT solutions, manual PACS data dumping, etc., and diverse pathways can be used to bring the data to impact clinical practice. The speakers will share their experiences with creating or tailoring radiation dose monitoring/management systems and procedures over the past few years, which vary significantly in design and scope. Topics to cover: (1) fluoroscopic dose monitoring and high radiation event handling from a large academic hospital; (2) dose monitoring and protocol optimization in pediatric radiology; and (3) development of a home-grown IT solution and dose data analysis framework. Learning Objectives: Describe the scope and range of radiation dose monitoring and protocol management in a modern radiology practice Review examples of data available from a variety of systems and how it managed and conveyed. Reflect on the role of the physicist in radiation dose awareness.« less

Closed treatment of unilateral mandibular condyle fractures in adults: a systematic review.

PubMed

Rozeboom, A V J; Dubois, L; Bos, R R M; Spijker, R; de Lange, J

2017-04-01

Of all mandibular fractures, 25-35% are condylar. Many studies have focused on whether to treat such fractures via open or closed modalities. A uniform protocol for closed treatment is lacking, but such a protocol could ensure good clinical practice. The aims of this systematic review were to provide an overview of the published studies exclusively pertaining to closed treatment and to summarize the existing modalities for closed treatment and their clinical outcomes. Sixteen studies were selected for detailed analysis. The treatments given were highly variable, ranging from doing nothing to applying maxillomandibular fixation with stainless steel wires. The results of the different studies and the treatment modalities used were difficult to interpret; however no clear differences in the outcome measures were seen between the treatment modalities applied. Complications encountered after closed treatment included malocclusion, limited mouth opening, reduced range of motion, and persistent pain. Due to the heterogeneity between groups, high loss-to-follow-up, poor descriptions of the treatments given, and variability in outcome measurement methods, no clear associations between adverse outcomes and the treatments applied could be determined. This review suggests that due to the high level of methodological variability in the relevant studies published to date, there are currently no uniform standards for the closed treatment of condylar fractures that can be expected to yield good clinical results. The establishment of such standards could potentially improve treatment outcomes. Copyright © 2016 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Informed consent in human research: what to say and how to say it.

PubMed

Reiman, Robert E

2013-02-01

To ensure that the possibility of harm to human research subjects is minimized, clinical trials and other research protocols are subject to oversight by Institutional Review Boards (IRBs). IRBs require that subjects be fully informed about the real or potential risks of participation in a research study. The use of radiological examinations in research protocols subjects the participants to exposure to ionizing radiation, which in theory carries a risk of stochastic effects such as radiation-induced cancer, and in practice may lead to deterministic effects such as skin injury. Because IRB members and clinical study coordinators may have little knowledge of radiation effects or how best to communicate the risk to the research subjects, they will consult with institutional Radiation Safety Committees and radiation protection professionals regarding how to integrate radiation risk information into the informed consent process. Elements of radiation informed consent include: (1) comparison of the radiation dose to some benchmark that enables the study subjects to make a value judgment regarding the acceptability of the risk; (2) a quantitative expression of the absolute risk of stochastic effects; (3) an expression of uncertainty in the risk; and (4) understandability. Standardized risk statement templates may be created for specific radiological examinations. These standardized risk statements may be deployed as paper forms or electronically in the form of internet-based applications. The technical nature of creating useful radiation risk statements represents an opportunity for radiation protection professionals to participate productively in the clinical research process.

The use of autologous platelet-rich plasma in the orthopedic setting.

PubMed

Cohn, Claudia S; Lockhart, Evelyn; McCullough, J Jeffrey

2015-07-01

Autologous platelet-rich plasma (aPRP) is widely used with orthopedic patients to help treat injuries to tendons, cartilage, ligaments, and muscle. A comprehensive review of the literature was conducted to evaluate aPRP's efficacy and compare available methods. In addition, the production and administration of aPRP were explored. A literature search was performed. Randomized controlled clinical trials (RCTs) in orthopedic procedures on adult patients were included and assessed for methodologic quality. The main outcomes were pain relief, increase in function, structural integrity, and "healing" based on various validated scales. Twelve RCTs and one controlled cohort were included (four lateral epicondylitis, two chronic Achilles tendinopathy, two anterior cruciate ligament injury, and five rotator cuff injuries). Four trials reported some benefit from aPRP versus controls while eight trials found no benefit from aPRP applications versus control. One study had too many patients withdraw from the control arm for acceptable data interpretation. All protocols used a different aPRP formulation or method of delivery or application. Despite its popularity, there are no standardized criteria that define aPRP. Different techniques yield wide variability in terms of platelet count and concentration. These variations make it difficult to compare clinical trials that use aPRP or draw conclusions concerning its clinical efficacy in orthopedic procedures. Blood bankers have experience in the production of standardized blood components. This expertise may be used to develop and implement protocols for the production and administration of aPRP, as well as quality control measures. © 2015 AABB.

Factors affecting the cost-effectiveness of on-farm culture prior to the treatment of clinical mastitis in dairy cows.

PubMed

Down, P M; Bradley, A J; Breen, J E; Green, M J

2017-09-15

The objective of this study was to use probabilistic sensitivity analysis to evaluate the cost-effectiveness of using an on-farm culture (OFC) approach to the treatment of clinical mastitis in dairy cows and compare this to a 'standard' treatment approach. A specific aim was to identify the herd circumstances under which an OFC approach would be most likely to be cost-effective. A stochastic Monte Carlo model was developed to simulate 5000 cases of clinical mastitis at the cow level and to calculate the associated costs simultaneously when treated according to 2 different treatment protocols; i) a 'conventional' approach (3 tubes of intramammary antibiotic) and ii) an OFC programme, whereby cows are treated according to the results of OFC. Model parameters were taken from recent peer reviewed literature on the use of OFC prior to treatment of clinical mastitis. Spearman rank correlation coefficients were used to evaluate the relationships between model input values and the estimated difference in cost between the standard and OFC treatment protocols. The simulation analyses revealed that both the difference in the bacteriological cure rate due to a delay in treatment when using OFC and the proportion of Gram-positive cases that occur on a dairy unit would have a fundamental impact on whether OFC would be cost-effective. The results of this study illustrated that an OFC approach for the treatment of clinical mastitis would probably not be cost-effective in many circumstances, in particular, not those in which Gram-positive pathogens were responsible for more than 20% of all clinical cases. The results highlight an ethical dilemma surrounding reduced use of antimicrobials for clinical mastitis since it may be associated with financial losses and poorer cow welfare in many instances. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

The use of high-fidelity human patient simulation as an evaluative tool in the development of clinical research protocols and procedures.

PubMed

Wright, Melanie C; Taekman, Jeffrey M; Barber, Linda; Hobbs, Gene; Newman, Mark F; Stafford-Smith, Mark

2005-12-01

Errors in clinical research can be costly, in terms of patient safety, data integrity, and data collection. Data inaccuracy in early subjects of a clinical study may be associated with problems in the design of the protocol, procedures, and data collection tools. High-fidelity patient simulation centers provide an ideal environment to apply human-centered design to clinical trial development. A draft of a complex clinical protocol was designed, evaluated and modified using a high-fidelity human patient simulator in the Duke University Human Simulation and Patient Safety Center. The process included walk-throughs, detailed modifications of the protocol and development of procedural aids. Training of monitors and coordinators provided an opportunity for observation of performance that was used to identify further improvements to the protocol. Evaluative steps were used to design the research protocol and procedures. Iterative modifications were made to the protocol and data collection tools. The success in use of human simulation in the preparation of a complex clinical drug trial suggests the benefits of human patient simulation extend beyond training and medical equipment evaluation. Human patient simulation can provide a context for informal expert evaluation of clinical protocol design and for formal "rehearsal" to evaluate the efficacy of procedures and support tools.

A randomized noninferiority trial of condensed protocols for genetic risk disclosure of Alzheimer's disease.

PubMed

Green, Robert C; Christensen, Kurt D; Cupples, L Adrienne; Relkin, Norman R; Whitehouse, Peter J; Royal, Charmaine D M; Obisesan, Thomas O; Cook-Deegan, Robert; Linnenbringer, Erin; Butson, Melissa Barber; Fasaye, Grace-Ann; Levinson, Elana; Roberts, J Scott

2015-10-01

Conventional multisession genetic counseling is currently recommended when disclosing apolipoprotein E (APOE) genotype for the risk of Alzheimer's disease (AD) in cognitively normal individuals. The objective of this study was to evaluate the safety of brief disclosure protocols for disclosing APOE genotype for the risk of AD. A randomized, multicenter noninferiority trial was conducted at four sites. Participants were asymptomatic adults having a first-degree relative with AD. A standard disclosure protocol by genetic counselors (SP-GC) was compared with condensed protocols, with disclosures by genetic counselors (CP-GC) and by physicians (CP-MD). Preplanned co-primary outcomes were anxiety and depression scales 12 months after disclosure. Three hundred and forty-three adults (mean age 58.3, range 33-86 years, 71% female, 23% African American) were randomly assigned to the SP-GC protocol (n = 115), CP-GC protocol (n = 116), or CP-MD protocol (n = 112). Mean postdisclosure scores on all outcomes were well below cut-offs for clinical concern across protocols. Comparing CP-GC with SP-GC, the 97.5% upper confidence limits at 12 months after disclosure on co-primary outcomes of anxiety and depression ranged from a difference of 1.2 to 2.0 in means (all P < .001 on noninferiority tests), establishing noninferiority for condensed protocols. Results were similar between European Americans and African Americans. These data support the safety of condensed protocols for APOE disclosure for those free of severe anxiety or depression who are actively seeking such information. Copyright © 2015 The Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

Standards for reporting chronic periodontitis prevalence and severity in epidemiologic studies: Proposed standards from the Joint EU/USA Periodontal Epidemiology Working Group.

PubMed

Holtfreter, Birte; Albandar, Jasim M; Dietrich, Thomas; Dye, Bruce A; Eaton, Kenneth A; Eke, Paul I; Papapanou, Panos N; Kocher, Thomas

2015-05-01

Periodontal diseases are common and their prevalence varies in different populations. However, prevalence estimates are influenced by the methodology used, including measurement techniques, case definitions, and periodontal examination protocols, as well as differences in oral health status. As a consequence, comparisons between populations are severely hampered and inferences regarding the global variation in prevalence can hardly be drawn. To overcome these limitations, the authors suggest standardized principles for the reporting of the prevalence and severity of periodontal diseases in future epidemiological studies. These principles include the comprehensive reporting of the study design, the recording protocol, and specific subject-related and oral data. Further, a range of periodontal data should be reported in the total population and within specific age groups. Periodontal data include the prevalence and extent of clinical attachment loss (CAL) and probing depth (PD) on site and tooth level according to specific thresholds, mean CAL/PD, the CDC/AAP case definition, and bleeding on probing. Consistent implementation of these standards in future studies will ensure improved reporting quality, permit meaningful comparisons of the prevalence of periodontal diseases across populations, and provide better insights into the determinants of such variation. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement.

PubMed

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-05-15

To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future.

Aerospace physiology.

DOT National Transportation Integrated Search

2004-01-01

This document defines the protocol standards for the Internet Protocol Suite (IPS), which is commonly referred to as Transmission Control Protocol/Internet Protocol (TCP/IP) protocols used for data communications within the National Airspace System (...

Role of imaging in testicular cancer: current and future practice.

PubMed

Barrisford, Glen W; Kreydin, Evgeniy I; Preston, Mark A; Rodriguez, Dayron; Harisighani, Mukesh G; Feldman, Adam S

2015-09-01

The article provides a summary of the epidemiologic and clinical aspects of testicular malignancy. Current standard imaging and novel techniques are reviewed. Present data and clinical treatment trends have favored surveillance protocols over adjuvant radiation or chemotherapy for low-stage testicular malignancy. This has resulted in increasing numbers of imaging studies and the potential for increased long-term exposure risks. Understanding imaging associated risks as well as strategies to minimize these risks is of increasing importance. The development, validation and incorporation of alternative lower risk highly efficacious and cost-effective imaging techniques is essential.

Expanding Role of Data Science and Bioinformatics in Drug Discovery and Development.

PubMed

Fingert, Howard J

2018-01-01

Numerous barriers have been identified which detract from successful applications of clinical trial data and platforms. Despite the challenges, opportunities are growing to advance compliance, quality, and practical applications through top-down establishment of guiding principles, coupled with bottom-up approaches to promote data science competencies among data producers. Recent examples of successful applications include modern treatments for hematologic malignancies, developed with support from public-private partnerships, guiding principles for data-sharing, standards for protocol designs and data management, digital technologies, and quality analytics. © 2017 American Society for Clinical Pharmacology and Therapeutics.

Clinical experience with a high-performance ATM-connected DICOM archive for cardiology

NASA Astrophysics Data System (ADS)

Solomon, Harry P.

1997-05-01

A system to archive large image sets, such as cardiac cine runs, with near realtime response must address several functional and performance issues, including efficient use of a high performance network connection with standard protocols, an architecture which effectively integrates both short- and long-term mass storage devices, and a flexible data management policy which allows optimization of image distribution and retrieval strategies based on modality and site-specific operational use. Clinical experience with such as archive has allowed evaluation of these systems issues and refinement of a traffic model for cardiac angiography.

[Phenylephrine dosing error in Intensive Care Unit. Case of the trimester].

PubMed

2013-01-01

A real clinical case reported to SENSAR is presented. A patient admitted to the surgical intensive care unit following a lung resection, suffered arterial hypotension. The nurse was asked to give the patient 1 mL of phenylephrine. A few seconds afterwards, the patient experienced a hypertensive crisis, which resolved spontaneously without damage. Thereafter, the nurse was interviewed and a dosing error was identified: she had mistakenly given the patient 1 mg of phenylephrine (1 mL) instead of 100 mcg (1 mL of the standard dilution, 1mg in 10 mL). The incident analysis revealed latent factors (event triggers) due to the lack of protocols and standard operating procedures, communication errors among team members (physician-nurse), suboptimal training, and underdeveloped safety culture. In order to preempt similar incidents in the future, the following actions were implemented in the surgical intensive care unit: a protocol for bolus and short lived infusions (<30 min) was developed and to close the communication gap through the adoption of communication techniques. The protocol was designed by physicians and nurses to standardize the administration of drugs with high potential for errors. To close the communication gap, repeated checks about saying and understanding was proposed ("closed loop"). Labeling syringes with the drug dilution was also recommended. Copyright © 2013 Sociedad Española de Anestesiología, Reanimación y Terapéutica del Dolor. Published by Elsevier España. All rights reserved.

Abbreviated Combined MR Protocol: A New Faster Strategy for Characterizing Breast Lesions.

PubMed

Moschetta, Marco; Telegrafo, Michele; Rella, Leonarda; Stabile Ianora, Amato Antonio; Angelelli, Giuseppe

2016-06-01

The use of an abbreviated magnetic resonance (MR) protocol has been recently proposed for cancer screening. The aim of our study is to evaluate the diagnostic accuracy of an abbreviated MR protocol combining short TI inversion recovery (STIR), turbo-spin-echo (TSE)-T2 sequences, a pre-contrast T1, and a single intermediate (3 minutes after contrast injection) post-contrast T1 sequence for characterizing breast lesions. A total of 470 patients underwent breast MR examination for screening, problem solving, or preoperative staging. Two experienced radiologists evaluated both standard and abbreviated protocols in consensus. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and diagnostic accuracy for both protocols were calculated (with the histological findings and 6-month ultrasound follow-up as the reference standard) and compared with the McNemar test. The post-processing and interpretation times for the MR images were compared with the paired t test. In 177 of 470 (38%) patients, the MR sequences detected 185 breast lesions. Standard and abbreviated protocols obtained sensitivity, specificity, diagnostic accuracy, PPV, and NPV values respectively of 92%, 92%, 92%, 68%, and 98% and of 89%, 91%, 91%, 64%, and 98% with no statistically significant difference (P < .0001). The mean post-processing and interpretation time were, respectively, 7 ± 1 minutes and 6 ± 3.2 minutes for the standard protocol and 1 ± 1.2 minutes and 2 ± 1.2 minutes for the abbreviated protocol, with a statistically significant difference (P < .01). An abbreviated combined MR protocol represents a time-saving tool for radiologists and patients with the same diagnostic potential as the standard protocol in patients undergoing breast MRI for screening, problem solving, or preoperative staging. Copyright © 2016 Elsevier Inc. All rights reserved.

Standardization of haematology critical results management in adults: an International Council for Standardization in Haematology, ICSH, survey and recommendations.

PubMed

Keng, T B; De La Salle, B; Bourner, G; Merino, A; Han, J-Y; Kawai, Y; Peng, M T; McCafferty, R

2016-10-01

These recommendations are intended to develop a consensus in the previously published papers as to which parameters and what values should be considered critical. A practical guide on the standardization of critical results management in haematology laboratories would be beneficial as part of good laboratory and clinical practice and for use by laboratory-accrediting agencies. A working group with members from Europe, America, Australasia and Asia was formed by International Council for Standardization in Haematology. A pattern of practice survey of 21 questions was distributed in 2014, and the data were collected electronically by Survey Monkey. The mode, or most commonly occurring value, was selected as the threshold for the upper and lower alert limits for critical results reporting. A total of 666 laboratories submitted data to this study and, of these, 499 submitted complete responses. Full blood count critical results alert thresholds, morphology findings that trigger critical result notification, critical results alert list, notification process and maintenance of critical results management protocol are described. This international survey provided a snapshot of the current practice worldwide and has identified the existence of considerable heterogeneity of critical results management. The recommendations in this study represent a consensus of good laboratory practice. They are intended to encourage the implementation of a standardized critical results management protocol in the laboratory. © 2016 John Wiley & Sons Ltd.

Implementation and Evaluation of Four Interoperable Open Standards for the Internet of Things.

PubMed

Jazayeri, Mohammad Ali; Liang, Steve H L; Huang, Chih-Yuan

2015-09-22

Recently, researchers are focusing on a new use of the Internet called the Internet of Things (IoT), in which enabled electronic devices can be remotely accessed over the Internet. As the realization of IoT concept is still in its early stages, manufacturers of Internet-connected devices and IoT web service providers are defining their proprietary protocols based on their targeted applications. Consequently, IoT becomes heterogeneous in terms of hardware capabilities and communication protocols. Addressing these heterogeneities by following open standards is a necessary step to communicate with various IoT devices. In this research, we assess the feasibility of applying existing open standards on resource-constrained IoT devices. The standard protocols developed in this research are OGC PUCK over Bluetooth, TinySOS, SOS over CoAP, and OGC SensorThings API. We believe that by hosting open standard protocols on IoT devices, not only do the devices become self-describable, self-contained, and interoperable, but innovative applications can also be easily developed with standardized interfaces. In addition, we use memory consumption, request message size, response message size, and response latency to benchmark the efficiency of the implemented protocols. In all, this research presents and evaluates standard-based solutions to better understand the feasibility of applying existing standards to the IoT vision.

The neurofibromatoses.

PubMed

Ferner, Rosalie E

2010-04-01

Neurofibromatosis 1 (NF1) and neurofibromatosis 2 (NF2) are inherited autosomal dominant disorders that have a significant impact on the nervous system and predispose to tumour formation. The current nomenclature makes NF1 and NF2 awkward bedfellows because they are clinically and genetically separate disorders. Neurofibromas are characteristic of NF1, a common condition with major skin involvement and many clinical complications. By contrast, schwannomas are the distinctive lesions in NF2, cutaneous signs are less prominent in this rarer disorder and clinical manifestations are largely restricted to the nervous system and eye. The current aim of neurofibromatosis specialists is to provide cohesive standards of care for everyone with neurofibromatosis and to devise standardised protocols for assessment and management within a multidisciplinary setting.

The Effect of Coded Healing Abutments on Treatment Duration and Clinical Outcome: A Randomized Controlled Clinical Trial Comparing Encode and Conventional Impression Protocols.

PubMed

Abduo, Jaafar; Chen, Chen; Le Breton, Eugene; Radu, Alexandra; Szeto, Josephine; Judge, Roy; Darby, Ivan

To compare the Encode impression protocol (Biomet 3i) with the conventional impression protocol in terms of treatment duration, clinical accuracy, and outcome up to the first postplacement review of single-implant crowns. A total of 45 implants were included in this study. The implants were randomly allocated to the Encode group (23 implants) or the conventional group (22 implants). At the time of surgery, all implants received two-piece Encode healing abutments. The implants were restored 3 months after insertion. In the conventional protocol, open-tray implant-level impressions were taken and the implants were restored with prefabricated abutments and porcelain-fused-to-metal (PFM) crowns. For the implants in the Encode group, closed-tray impressions of the healing abutments were taken. The generated casts were sent to the Biomet 3i scanning/milling center for custom abutment manufacturing on which PFM crowns were fabricated. Treatment duration (laboratory and clinical), clinical accuracy of occlusal and proximal contacts, and outcome (esthetics, patient satisfaction, and crown contour) were evaluated with the aid of a series of questionnaires. The Encode protocol required significantly less laboratory time (18 minutes) than the conventional protocol for adjustment of the abutments. The impression pour time, time for the laboratory to return the crown, time for crown insertion at the final appointment, and total clinical time for crown insertion did not differ significantly between the two protocols. Likewise, clinical accuracy, esthetics, and patient satisfaction were similar for the two protocols. The two protocols were clinically comparable. The Encode protocol is advantageous in reducing the laboratory time before crown fabrication.

Improvements in Clinical Trials Information Will Improve the Reproductive Health and Fertility of Cancer Patients.

PubMed

Dauti, Angela; Gerstl, Brigitte; Chong, Serena; Chisholm, Orin; Anazodo, Antoinette

2017-06-01

There are a number of barriers that result in cancer patients not being referred for oncofertility care, which include knowledge about reproductive risks of antineoplastic agents. Without this information, clinicians do not always make recommendations for oncofertility care. The objective of this study was to describe the level of reproductive information and recommendations that clinicians have available in clinical trial protocols regarding oncofertility management and follow-up, and the information that patients may receive in clinical trials patient information sheets or consent forms. A literature review of the 71 antineoplastic drugs included in the 68 clinical trial protocols showed that 68% of the antineoplastic drugs had gonadotoxic animal data, 32% had gonadotoxic human data, 83% had teratogenic animal data, and 32% had teratogenic human data. When the clinical trial protocols were reviewed, only 22% of the protocols reported the teratogenic risks and 32% of the protocols reported the gonadotoxic risk. Only 56% of phase 3 protocols had gonadotoxic information and 13% of phase 3 protocols had teratogenic information. Nine percent of the protocols provided fertility preservation recommendations and 4% provided reproductive information in the follow-up and survivorship period. Twenty-six percent had a section in the clinical trials protocol, which identified oncofertility information easily. When gonadotoxic and teratogenic effects of treatment were known, they were not consistently included in the clinical trial protocols and the lack of data for new drugs was not reported. Very few protocols gave recommendations for oncofertility management and follow-up following the completion of cancer treatment. The research team proposes a number of recommendations that should be required for clinicians and pharmaceutical companies developing new trials.

Examining the effects of enhanced provider-patient communication on postoperative tonsillectomy pain: protocol of a randomised controlled trial performed by nurses in daily clinical care.

PubMed

van Vliet, Liesbeth M; van Dulmen, Sandra; Thiel, Bram; van Deelen, Gerard W; Immerzeel, Stephanie; Godfried, Marc B; Bensing, Jozien M

2017-11-03

Placebo effects (true biopsychological effects not attributable to the active ingredients of medical technical interventions) can be attributed to several mechanisms, such as expectancy manipulation and empathy manipulation elicited by a provider's communication. So far, effects have primarily been shown in laboratory settings. The aim of this study is to determine the separate and combined effects of expectancy manipulation and empathy manipulation during preoperative and postoperative tonsillectomy analgesia care on clinical adult patients' outcomes. Using a two-by-two randomised controlled trial, 128 adult tonsillectomy patients will be randomly assigned to one out of four conditions differing in the level of expectancy manipulation (standard vs enhanced) and empathy manipulation (standard vs enhanced). Day care ward nurses are trained to deliver the intervention, while patients are treated via the standard analgesia protocol and hospital routines. The primary outcome, perceived pain, is measured via hospital routine by a Numeric Rating Scale, and additional prehospitalisation, perihospitalisation and posthospitalisation questionnaires are completed (until day 3, ie, 2 days after the operation). The manipulation is checked using audio recordings of nurse-patient interactions. Although communication is manipulated, the manipulations do not cross norms or values of acceptable behaviour. Standard medical care is provided. The ethical committee of the UMC Utrecht and the local OLVG hospital committee approved the study. Results will be published via (inter)national peer-reviewed journals and a lay publication. NTR5994; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Cardiac-Specific Conversion Factors to Estimate Radiation Effective Dose From Dose-Length Product in Computed Tomography.

PubMed

Trattner, Sigal; Halliburton, Sandra; Thompson, Carla M; Xu, Yanping; Chelliah, Anjali; Jambawalikar, Sachin R; Peng, Boyu; Peters, M Robert; Jacobs, Jill E; Ghesani, Munir; Jang, James J; Al-Khalidi, Hussein; Einstein, Andrew J

2018-01-01

This study sought to determine updated conversion factors (k-factors) that would enable accurate estimation of radiation effective dose (ED) for coronary computed tomography angiography (CTA) and calcium scoring performed on 12 contemporary scanner models and current clinical cardiac protocols and to compare these methods to the standard chest k-factor of 0.014 mSv·mGy -1 cm -1 . Accurate estimation of ED from cardiac CT scans is essential to meaningfully compare the benefits and risks of different cardiac imaging strategies and optimize test and protocol selection. Presently, ED from cardiac CT is generally estimated by multiplying a scanner-reported parameter, the dose-length product, by a k-factor which was determined for noncardiac chest CT, using single-slice scanners and a superseded definition of ED. Metal-oxide-semiconductor field-effect transistor radiation detectors were positioned in organs of anthropomorphic phantoms, which were scanned using all cardiac protocols, 120 clinical protocols in total, on 12 CT scanners representing the spectrum of scanners from 5 manufacturers (GE, Hitachi, Philips, Siemens, Toshiba). Organ doses were determined for each protocol, and ED was calculated as defined in International Commission on Radiological Protection Publication 103. Effective doses and scanner-reported dose-length products were used to determine k-factors for each scanner model and protocol. k-Factors averaged 0.026 mSv·mGy -1 cm -1 (95% confidence interval: 0.0258 to 0.0266) and ranged between 0.020 and 0.035 mSv·mGy -1 cm -1 . The standard chest k-factor underestimates ED by an average of 46%, ranging from 30% to 60%, depending on scanner, mode, and tube potential. Factors were higher for prospective axial versus retrospective helical scan modes, calcium scoring versus coronary CTA, and higher (100 to 120 kV) versus lower (80 kV) tube potential and varied among scanner models (range of average k-factors: 0.0229 to 0.0277 mSv·mGy -1 cm -1 ). Cardiac k-factors for all scanners and protocols are considerably higher than the k-factor currently used to estimate ED of cardiac CT studies, suggesting that radiation doses from cardiac CT have been significantly and systematically underestimated. Using cardiac-specific factors can more accurately inform the benefit-risk calculus of cardiac-imaging strategies. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

EPA Traceability Protocol for Assay and Certification of Gaseous Calibration Standards (EPA/600/R-12/531, May 2012)

EPA Science Inventory

In 1997, the U.S. Environmental Protection Agency (EPA) in Research Triangle Park, North Carolina, revised its 1993 version of its traceability protocol for the assay and certification of compressed gas and permeation-device calibration standards. The protocol allows producers of...

Security Issues for Mobile Medical Imaging: A Primer.

PubMed

Choudhri, Asim F; Chatterjee, Arindam R; Javan, Ramin; Radvany, Martin G; Shih, George

2015-10-01

The end-user of mobile device apps in the practice of clinical radiology should be aware of security measures that prevent unauthorized use of the device, including passcode policies, methods for dealing with failed login attempts, network manager-controllable passcode enforcement, and passcode enforcement for the protection of the mobile device itself. Protection of patient data must be in place that complies with the Health Insurance Portability and Accountability Act and U.S. Federal Information Processing Standards. Device security measures for data protection include methods for locally stored data encryption, hardware encryption, and the ability to locally and remotely clear data from the device. As these devices transfer information over both local wireless networks and public cell phone networks, wireless network security protocols, including wired equivalent privacy and Wi-Fi protected access, are important components in the chain of security. Specific virtual private network protocols, Secure Sockets Layer and related protocols (especially in the setting of hypertext transfer protocols), native apps, virtual desktops, and nonmedical commercial off-the-shelf apps require consideration in the transmission of medical data over both private and public networks. Enterprise security and management of both personal and enterprise mobile devices are discussed. Finally, specific standards for hardware and software platform security, including prevention of hardware tampering, protection from malicious software, and application authentication methods, are vital components in establishing a secure platform for the use of mobile devices in the medical field. © RSNA, 2015.

CT protocol management: simplifying the process by using a master protocol concept.

PubMed

Szczykutowicz, Timothy P; Bour, Robert K; Rubert, Nicholas; Wendt, Gary; Pozniak, Myron; Ranallo, Frank N

2015-07-08

This article explains a method for creating CT protocols for a wide range of patient body sizes and clinical indications, using detailed tube current information from a small set of commonly used protocols. Analytical expressions were created relating CT technical acquisition parameters which can be used to create new CT protocols on a given scanner or customize protocols from one scanner to another. Plots of mA as a function of patient size for specific anatomical regions were generated and used to identify the tube output needs for patients as a function of size for a single master protocol. Tube output data were obtained from the DICOM header of clinical images from our PACS and patient size was measured from CT localizer radiographs under IRB approval. This master protocol was then used to create 11 additional master protocols. The 12 master protocols were further combined to create 39 single and multiphase clinical protocols. Radiologist acceptance rate of exams scanned using the clinical protocols was monitored for 12,857 patients to analyze the effectiveness of the presented protocol management methods using a two-tailed Fisher's exact test. A single routine adult abdominal protocol was used as the master protocol to create 11 additional master abdominal protocols of varying dose and beam energy. Situations in which the maximum tube current would have been exceeded are presented, and the trade-offs between increasing the effective tube output via 1) decreasing pitch, 2) increasing the scan time, or 3) increasing the kV are discussed. Out of 12 master protocols customized across three different scanners, only one had a statistically significant acceptance rate that differed from the scanner it was customized from. The difference, however, was only 1% and was judged to be negligible. All other master protocols differed in acceptance rate insignificantly between scanners. The methodology described in this paper allows a small set of master protocols to be adapted among different clinical indications on a single scanner and among different CT scanners.

Dose uniformity analysis among ten 16-slice same-model CT scanners.

PubMed

Erdi, Yusuf Emre

2012-01-01

With the introduction of multislice scanners, computed tomographic (CT) dose optimization has become important. The patient-absorbed dose may differ among the scanners although they are the same type and model. To investigate the dose output variation of the CT scanners, we designed the study to analyze dose outputs of 10 same-model CT scanners using 3 clinical protocols. Ten GE Lightspeed (GE Healthcare, Waukesha, Wis) 16-slice scanners located at main campus and various satellite locations of our institution have been included in this study. All dose measurements were performed using poly (methyl methacrylate) (PMMA) head (diameter, 16 cm) and body (diameter, 32 cm) phantoms manufactured by Radcal (RadCal Corp, Monrovia, Calif) using a 9095 multipurpose analyzer with 10 × 9-3CT ion chamber both from the same manufacturer. Ion chamber is inserted into the peripheral and central axis locations and volume CT dose index (CTDIvol) is calculated as weighted average of doses at those locations. Three clinical protocol settings for adult head, high-resolution chest, and adult abdomen are used for dose measurements. We have observed up to 9.4% CTDIvol variation for the adult head protocol in which the largest variation occurred among the protocols. However, head protocol uses higher milliampere second values than the other 2 protocols. Most of the measured values were less than the system-stored CTDIvol values. It is important to note that reduction in dose output from tubes as they age is expected in addition to the intrinsic radiation output fluctuations of the same scanner. Although the same model CT scanners were used in this study, it is possible to see CTDIvol variation in standard patient scanning protocols of head, chest, and abdomen. The compound effect of the dose variation may be larger with higher milliampere and multiphase and multilocation CT scans.

Clinically Practical Magnetic Resonance Protocol for Improved Specificity in Breast Cancer Diagnosis

DTIC Science & Technology

2007-06-01

Protocol for Improved Specificity in Breast Cancer Diagnosis PRINCIPAL INVESTIGATOR: Luminita Alina Tudorica, Ph.D. CONTRACTING...TITLE AND SUBTITLE 5a. CONTRACT NUMBER Clinically Practical Magnetic Resonance Protocol for Improved Specificity in Breast Cancer Diagnosis 5b... breast cancer study in a clinical setting. This study aims to improve specificity of breast cancer detection by using a combined MRI/MRS protocol. In

Colon cleansing protocol in children: research conditions vs. clinical practice.

PubMed

Elitsur, Yoram; Balfaqih, Yaslam; Preston, Deborah

2018-04-01

 Colon preparation rates are the limiting factor for a successful diagnostic colonoscopy in children. Different colon cleansing protocols have been published for use in children. Unfortunately, the applicability of those published research protocols has not been formally evaluated in routine clinical practice. We investigated the success rate of our previously published colon cleansing protocol as utilized in our clinical practice.  This was a retrospective study. In the clinical practice, the colon cleansing protocol included PEG-3350 at a dose of 2 g/kg/day plus Dulcolax (Bisacodyl, Boehringer Ingelheim, TX USA) 5 mg/day for 2 days. Adequate colon preparation was graded between 1 - 5, as previously described, and grade ≥ 4.0 was considered an adequate preparation. Patients were instructed to complete a questionnaire that included PEG-3350 dose, number of stools per day, consistency of each stool, and side effects (vomiting, abdominal pain). Clinical and endoscopic results were compared between the protocol under research conditions and routine practice.  The success rate of the colon preparation in our clinical practice was similar to the results observed under our research protocol (75 % vs. 73.6 %). Moreover, the total number of stools, stool consistency, and the intubation rate of the terminal ileum were also similar. We concluded, that in our experience, the colon cleansing protocol used under research conditions was effective and appropriate for use in routine clinical practice.  We recommend testing each new protocol under the routine conditions of clinical practice to confirm its applicability for general practitioners.

Efficacy of intermittent Theta Burst Stimulation (iTBS) and 10-Hz high-frequency repetitive transcranial magnetic stimulation (rTMS) in treatment-resistant unipolar depression: study protocol for a randomised controlled trial.

PubMed

Bulteau, Samuel; Sébille, Veronique; Fayet, Guillemette; Thomas-Ollivier, Veronique; Deschamps, Thibault; Bonnin-Rivalland, Annabelle; Laforgue, Edouard; Pichot, Anne; Valrivière, Pierre; Auffray-Calvier, Elisabeth; Fortin, June; Péréon, Yann; Vanelle, Jean-Marie; Sauvaget, Anne

2017-01-13

The treatment of depression remains a challenge since at least 40% of patients do not respond to initial antidepressant therapy and 20% present chronic symptoms (more than 2 years despite standard treatment administered correctly). Repetitive transcranial magnetic stimulation (rTMS) is an effective adjuvant therapy but still not ideal. Intermittent Theta Burst Stimulation (iTBS), which has only been used recently in clinical practice, could have a faster and more intense effect compared to conventional protocols, including 10-Hz high-frequency rTMS (HF-rTMS). However, no controlled study has so far highlighted the superiority of iTBS in resistant unipolar depression. This paper focuses on the design of a randomised, controlled, double-blind, single-centre study with two parallel arms, carried out in France, in an attempt to assess the efficacy of an iTBS protocol versus a standard HF- rTMS protocol. Sixty patients aged between 18 and 75 years of age will be enrolled. They must be diagnosed with major depressive disorder persisting despite treatment with two antidepressants at an effective dose over a period of 6 weeks during the current episode. The study will consist of two phases: a treatment phase comprising 20 sessions of rTMS to the left dorsolateral prefrontal cortex, localised via a neuronavigation system and a 6-month longitudinal follow-up. The primary endpoint will be the number of responders per group, defined by a decrease of at least 50% in the initial score on the Montgomery and Asberg Rating Scale (MADRS) at the end of rTMS sessions. The secondary endpoints will be: response rate 1 month after rTMS sessions; number of remissions defined by a MADRS score of <8 at the endpoint and 1 month after; the number of responses and remissions maintained over the next 6 months; quality of life; and the presence of predictive markers of the therapeutic response: clinical (dimensional scales), neuropsychological (evaluation of cognitive functions), motor (objective motor testing) and neurophysiological (cortical excitability measurements). The purpose of our study is to check the assumption of iTBS superiority in the management of unipolar depression and we will discuss its effect over time. In case of a significant increase in the number of therapeutic responses with a prolonged effect, the iTBS protocol could be considered a first-line protocol in resistant unipolar depression. ClinicalTrials.gov, Identifier NCT02376491 . Registered on 17 February 2015 at http://clinicaltrials.gov .

Considerations in reporting palliative care clinical trials: Standardizing information reported and authorship practices

PubMed Central

LeBlanc, Thomas W.; Abernethy, Amy P.; Currow, David C.; Kutner, Jean S.

2014-01-01

Purpose of Review The nature of palliative care practice, especially the reliance on referrals and differing models of service delivery, poses unique challenges for the creation and interpretation of an evidence base, frequently limiting the applicability of data to patient care. Here we discuss two core aspects of clinical trials reporting in palliative medicine: 1) proposed standards governing the collection and reporting of data, and 2) rules governing authorship and publication. Recent Findings Existing literature often inadequately describes the characteristics of patients, caregivers, clinicians, systems, and interventions included in studies, thereby limiting the utility of results. Summary A generalizability framework is needed to ensure a robust evidence base that advances practice. Lessons learned through the development of research cooperative groups in palliative care reinforce the importance of an authorship protocol for large trials and working groups. PMID:23080306

SU-G-206-01: A Fully Automated CT Tool to Facilitate Phantom Image QA for Quantitative Imaging in Clinical Trials

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

Wahi-Anwar, M; Lo, P; Kim, H

Purpose: The use of Quantitative Imaging (QI) methods in Clinical Trials requires both verification of adherence to a specified protocol and an assessment of scanner performance under that protocol, which are currently accomplished manually. This work introduces automated phantom identification and image QA measure extraction towards a fully-automated CT phantom QA system to perform these functions and facilitate the use of Quantitative Imaging methods in clinical trials. Methods: This study used a retrospective cohort of CT phantom scans from existing clinical trial protocols - totaling 84 phantoms, across 3 phantom types using various scanners and protocols. The QA system identifiesmore » the input phantom scan through an ensemble of threshold-based classifiers. Each classifier - corresponding to a phantom type - contains a template slice, which is compared to the input scan on a slice-by-slice basis, resulting in slice-wise similarity metric values for each slice compared. Pre-trained thresholds (established from a training set of phantom images matching the template type) are used to filter the similarity distribution, and the slice with the most optimal local mean similarity, with local neighboring slices meeting the threshold requirement, is chosen as the classifier’s matched slice (if it existed). The classifier with the matched slice possessing the most optimal local mean similarity is then chosen as the ensemble’s best matching slice. If the best matching slice exists, image QA algorithm and ROIs corresponding to the matching classifier extracted the image QA measures. Results: Automated phantom identification performed with 84.5% accuracy and 88.8% sensitivity on 84 phantoms. Automated image quality measurements (following standard protocol) on identified water phantoms (n=35) matched user QA decisions with 100% accuracy. Conclusion: We provide a fullyautomated CT phantom QA system consistent with manual QA performance. Further work will include parallel component to automatically verify image acquisition parameters and automated adherence to specifications. Institutional research agreement, Siemens Healthcare; Past recipient, research grant support, Siemens Healthcare; Consultant, Toshiba America Medical Systems; Consultant, Samsung Electronics; NIH Grant support from: U01 CA181156.« less

Passive fMRI mapping of language function for pediatric epilepsy surgical planning: validation using Wada, ECS, and FMAER.

PubMed

Suarez, Ralph O; Taimouri, Vahid; Boyer, Katrina; Vega, Clemente; Rotenberg, Alexander; Madsen, Joseph R; Loddenkemper, Tobias; Duffy, Frank H; Prabhu, Sanjay P; Warfield, Simon K

2014-12-01

In this study we validate passive language fMRI protocols designed for clinical application in pediatric epilepsy surgical planning as they do not require overt participation from patients. We introduced a set of quality checks that assess reliability of noninvasive fMRI mappings utilized for clinical purposes. We initially compared two fMRI language mapping paradigms, one active in nature (requiring participation from the patient) and the other passive in nature (requiring no participation from the patient). Group-level analysis in a healthy control cohort demonstrated similar activation of the putative language centers of the brain in the inferior frontal (IFG) and temporoparietal (TPG) regions. Additionally, we showed that passive language fMRI produced more left-lateralized activation in TPG (LI=+0.45) compared to the active task; with similarly robust left-lateralized IFG (LI=+0.24) activations using the passive task. We validated our recommended fMRI mapping protocols in a cohort of 15 pediatric epilepsy patients by direct comparison against the invasive clinical gold-standards. We found that language-specific TPG activation by fMRI agreed to within 9.2mm to subdural localizations by invasive functional mapping in the same patients, and language dominance by fMRI agreed with Wada test results at 80% congruency in TPG and 73% congruency in IFG. Lastly, we tested the recommended passive language fMRI protocols in a cohort of very young patients and confirmed reliable language-specific activation patterns in that challenging cohort. We concluded that language activation maps can be reliably achieved using the passive language fMRI protocols we proposed even in very young (average 7.5 years old) or sedated pediatric epilepsy patients. Copyright © 2014 Elsevier B.V. All rights reserved.

Clinical Experience of Using Cortical Auditory Evoked Potentials in the Treatment of Infant Hearing Loss in Australia

PubMed Central

Punch, Simone; Van Dun, Bram; King, Alison; Carter, Lyndal; Pearce, Wendy

2016-01-01

This article presents the clinical protocol that is currently being used within Australian Hearing for infant hearing aid evaluation using cortical auditory evoked potentials (CAEPs). CAEP testing is performed in the free field at two stimulus levels (65 dB sound pressure level [SPL], followed by 55 or 75 dB SPL) using three brief frequency-distinct speech sounds /m/, /ɡ/, and /t/, within a standard audiological appointment of up to 90 minutes. CAEP results are used to check or guide modifications of hearing aid fittings or to confirm unaided hearing capability. A retrospective review of 83 client files evaluated whether clinical practice aligned with the clinical protocol. It showed that most children could be assessed as part of their initial fitting program when they were identified as a priority for CAEP testing. Aided CAEPs were most commonly assessed within 8 weeks of the fitting. A survey of 32 pediatric audiologists provided information about their perception of cortical testing at Australian Hearing. The results indicated that clinical CAEP testing influenced audiologists' approach to rehabilitation and was well received by parents and that they were satisfied with the technique. Three case studies were selected to illustrate how CAEP testing can be used in a clinical environment. Overall, CAEP testing has been effectively integrated into the infant fitting program. PMID:27587921

Recommendations for the Generation, Quantification, Storage, and Handling of Peptides Used for Mass Spectrometry-Based Assays.

PubMed

Hoofnagle, Andrew N; Whiteaker, Jeffrey R; Carr, Steven A; Kuhn, Eric; Liu, Tao; Massoni, Sam A; Thomas, Stefani N; Townsend, R Reid; Zimmerman, Lisa J; Boja, Emily; Chen, Jing; Crimmins, Daniel L; Davies, Sherri R; Gao, Yuqian; Hiltke, Tara R; Ketchum, Karen A; Kinsinger, Christopher R; Mesri, Mehdi; Meyer, Matthew R; Qian, Wei-Jun; Schoenherr, Regine M; Scott, Mitchell G; Shi, Tujin; Whiteley, Gordon R; Wrobel, John A; Wu, Chaochao; Ackermann, Brad L; Aebersold, Ruedi; Barnidge, David R; Bunk, David M; Clarke, Nigel; Fishman, Jordan B; Grant, Russ P; Kusebauch, Ulrike; Kushnir, Mark M; Lowenthal, Mark S; Moritz, Robert L; Neubert, Hendrik; Patterson, Scott D; Rockwood, Alan L; Rogers, John; Singh, Ravinder J; Van Eyk, Jennifer E; Wong, Steven H; Zhang, Shucha; Chan, Daniel W; Chen, Xian; Ellis, Matthew J; Liebler, Daniel C; Rodland, Karin D; Rodriguez, Henry; Smith, Richard D; Zhang, Zhen; Zhang, Hui; Paulovich, Amanda G

2016-01-01

For many years, basic and clinical researchers have taken advantage of the analytical sensitivity and specificity afforded by mass spectrometry in the measurement of proteins. Clinical laboratories are now beginning to deploy these work flows as well. For assays that use proteolysis to generate peptides for protein quantification and characterization, synthetic stable isotope-labeled internal standard peptides are of central importance. No general recommendations are currently available surrounding the use of peptides in protein mass spectrometric assays. The Clinical Proteomic Tumor Analysis Consortium of the National Cancer Institute has collaborated with clinical laboratorians, peptide manufacturers, metrologists, representatives of the pharmaceutical industry, and other professionals to develop a consensus set of recommendations for peptide procurement, characterization, storage, and handling, as well as approaches to the interpretation of the data generated by mass spectrometric protein assays. Additionally, the importance of carefully characterized reference materials-in particular, peptide standards for the improved concordance of amino acid analysis methods across the industry-is highlighted. The alignment of practices around the use of peptides and the transparency of sample preparation protocols should allow for the harmonization of peptide and protein quantification in research and clinical care. © 2015 American Association for Clinical Chemistry.

Advantage of four-electrode over two-electrode defibrillators

NASA Astrophysics Data System (ADS)

Bragard, J.; Šimić, A.; Laroze, D.; Elorza, J.

2015-12-01

Defibrillation is the standard clinical treatment used to stop ventricular fibrillation. An electrical device delivers a controlled amount of electrical energy via a pair of electrodes in order to reestablish a normal heart rate. We propose a technique that is a combination of biphasic shocks applied with a four-electrode system rather than the standard two-electrode system. We use a numerical model of a one-dimensional ring of cardiac tissue in order to test and evaluate the benefit of this technique. We compare three different shock protocols, namely a monophasic and two types of biphasic shocks. The results obtained by using a four-electrode system are compared quantitatively with those obtained with the standard two-electrode system. We find that a huge reduction in defibrillation threshold is achieved with the four-electrode system. For the most efficient protocol (asymmetric biphasic), we obtain a reduction in excess of 80% in the energy required for a defibrillation success rate of 90%. The mechanisms of successful defibrillation are also analyzed. This reveals that the advantage of asymmetric biphasic shocks with four electrodes lies in the duration of the cathodal and anodal phase of the shock.

The predictive value of skin prick testing for challenge-proven food allergy: a systematic review.

PubMed

Peters, Rachel L; Gurrin, Lyle C; Allen, Katrina J

2012-06-01

Immunoglobulin E-mediated (IgE) food allergy affects 6-8% of children, and the prevalence is believed to be increasing. The gold standard of food allergy diagnosis is oral food challenges (OFCs); however, they are resource-consuming and potentially dangerous. Skin prick tests (SPTs) are able to detect the presence of allergen-specific IgE antibodies (sensitization), but they have low specificity for clinically significant food allergy. To reduce the need for OFCs, it has been suggested that children forgo an OFC if their SPT wheal size exceeds a cutoff that has a high predictability for food allergy. Although data for these studies are almost always gathered from high-risk populations, the 95% positive predictive values (PPVs) vary substantially between studies. SPT thresholds with a high probability of food allergy generated from these studies may not be generalizable to other populations, because of highly selective samples and variability in participant's age, test allergens, and food challenge protocol. Standardization of SPT devices and allergens, OFC protocols including standardized cessation criteria, and population-based samples would all help to improve generalizability of PPVs of SPTs. © 2011 John Wiley & Sons A/S.

[Ventilatory dysfunction in motor neuron disease: when and how to act?].

PubMed

Rocha, J Afonso; Miranda, M J

2007-01-01

Amyotrophic lateral sclerosis is a devastating progressive neurodegenerative disorder, involving motor neurons in the cerebral cortex, brainstem and spinal cord. Mean duration of survival from the time of diagnosis is around 15 months, being pulmonary complications and respiratory failure responsible for more than 85% of deaths. Albeit the inevitability of respiratory failure and short-term death, standardized intervention protocols have been shown to significantly delay the need for invasive ventilatory support, thus prolonging survival and enhancing quality of life. The authors present an intervention protocol based on clinical progression and respiratory parameters. Decisions regarding initiation of non-invasive positive pressure ventilation (NIPPV) and mechanically assisted coughing, depend on development of symptoms of hypoventilation and on objective deterioration of respiratory parameters especially in what concerns bulbar muscle function. These include maximum inspiratory capacity (MIC), difference between MIC and vital capacity (MIC-VC), and assisted peak cough flow (PCF). These standardized protocols along with patient and caregivers education, allow for improved quality of life, prolonged survival and delay or eventually prevent the need for tracheotomy and invasive ventilatory support. Supplemental oxygen should be avoided in these patients, since it precludes use of oxymetry as feedback for titrating NIPPV and MAC, and is associated with decreased ventilatory drive and aggravated hypercapnia.

The role of digital imaging and communications in medicine in an evolving healthcare computing environment: the model is the message.

PubMed

Bidgood, W D; alSafadi, Y; Tucker, M; Prior, F; Hagan, G; Mattison, J E

1998-02-01

The decision to use Digital Imaging and Communications in Medicine (DICOM), Health Level 7 (HL7), a common object broker such as the Common Object Request Brokering Architecture (CORBA) or ActiveX (Microsoft Corp, Redmond, WA) or any other protocol for the transfer of DICOM data depends on the requirements of a particular implementation. The selection of protocol is independent of the information model. Our goal as message standards developers is to design a data interchange infrastructure that will faithfully convey the computer-based patient record and make it available to authorized health care providers when and where it is needed for patient care. DICOM accurately and expressively represents the clinically significant properties of images and the semantics of image-related information. The DICOM data model is small and well-defined. The model can be expressed in Standard Generalized Markup Language (SGML) or Object Management Group Interface Definition Language or other common syntax-and can be implemented using any reliable communications protocol. Therefore our opinion is that the DICOM semantic data model should serve as the basis for a logically equivalent set of specifications in HL7, CORBA, ActiveX, and SGML for the interchange of biomedical images and image-related information.

Clinical grade adult stem cell banking

PubMed Central

Thirumala, Sreedhar; Goebel, W Scott

2009-01-01

There has been a great deal of scientific interest recently generated by the potential therapeutic applications of adult stem cells in human care but there are several challenges regarding quality and safety in clinical applications and a number of these challenges relate to the processing and banking of these cells ex-vivo. As the number of clinical trials and the variety of adult cells used in regenerative therapy increases, safety remains a primary concern. This has inspired many nations to formulate guidelines and standards for the quality of stem cell collection, processing, testing, banking, packaging and distribution. Clinically applicable cryopreservation and banking of adult stem cells offers unique opportunities to advance the potential uses and widespread implementation of these cells in clinical applications. Most current cryopreservation protocols include animal serum proteins and potentially toxic cryoprotectant additives (CPAs) that prevent direct use of these cells in human therapeutic applications. Long term cryopreservation of adult stem cells under good manufacturing conditions using animal product free solutions is critical to the widespread clinical implementation of ex-vivo adult stem cell therapies. Furthermore, to avoid any potential cryoprotectant related complications, reduced CPA concentrations and efficient post-thaw washing to remove CPA are also desirable. The present review focuses on the current strategies and important aspects of adult stem cell banking for clinical applications. These include current good manufacturing practices (cGMPs), animal protein free freezing solutions, cryoprotectants, freezing & thawing protocols, viability assays, packaging and distribution. The importance and benefits of banking clinical grade adult stem cells are also discussed. PMID:20046678

Kilovoltage cone-beam CT: Comparative dose and image quality evaluations in partial and full-angle scan protocols

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

Kim, Sangroh; Yoo, Sua; Yin Fangfang

2010-07-15

Purpose: To assess imaging dose of partial and full-angle kilovoltage CBCT scan protocols and to evaluate image quality for each protocol. Methods: The authors obtained the CT dose index (CTDI) of the kilovoltage CBCT protocols in an on-board imager by ion chamber (IC) measurements and Monte Carlo (MC) simulations. A total of six new CBCT scan protocols were evaluated: Standard-dose head (100 kVp, 151 mA s, partial-angle), low-dose head (100 kVp, 75 mA s, partial-angle), high-quality head (100 kVp, 754 mA s, partial-angle), pelvis (125 kVp, 706 mA s, full-angle), pelvis spotlight (125 kVp, 752 mA s, partial-angle), and low-dosemore » thorax (110 kVp, 271 mA s, full-angle). Using the point dose method, various CTDI values were calculated by (1) the conventional weighted CTDI (CTDI{sub w}) calculation and (2) Bakalyar's method (CTDI{sub wb}). The MC simulations were performed to obtain the CTDI{sub w} and CTDI{sub wb}, as well as from (3) central slice averaging (CTDI{sub 2D}) and (4) volume averaging (CTDI{sub 3D}) techniques. The CTDI values of the new protocols were compared to those of the old protocols (full-angle CBCT protocols). Image quality of the new protocols was evaluated following the CBCT image quality assurance (QA) protocol [S. Yoo et al., ''A quality assurance program for the on-board imager registered ,'' Med. Phys. 33(11), 4431-4447 (2006)] testing Hounsfield unit (HU) linearity, spatial linearity/resolution, contrast resolution, and HU uniformity. Results: The CTDI{sub w} were found as 6.0, 3.2, 29.0, 25.4, 23.8, and 7.7 mGy for the new protocols, respectively. The CTDI{sub w} and CTDI{sub wb} differed within +3% between IC measurements and MC simulations. Method (2) results were within {+-}12% of method (1). In MC simulations, the CTDI{sub w} and CTDI{sub wb} were comparable to the CTDI{sub 2D} and CTDI{sub 3D} with the differences ranging from -4.3% to 20.6%. The CTDI{sub 3D} were smallest among all the CTDI values. CTDI{sub w} of the new protocols were found as {approx}14 times lower for standard head scan and 1.8 times lower for standard body scan than the old protocols, respectively. In the image quality QA tests, all the protocols except low-dose head and low-dose thorax protocols were within the tolerance in the HU verification test. The HU value for the two protocols was always higher than the nominal value. All the protocols passed the spatial linearity/resolution and HU uniformity tests. In the contrast resolution test, only high-quality head and pelvis scan protocols were within the tolerance. In addition, crescent effect was found in the partial-angle scan protocols. Conclusions: The authors found that CTDI{sub w} of the new CBCT protocols has been significantly reduced compared to the old protocols with acceptable image quality. The CTDI{sub w} values in the point dose method were close to the volume averaging method within 9%-21% for all the CBCT scan protocols. The Bakalyar's method produced more accurate dose estimation within 14%. The HU inaccuracy from low-dose head and low-dose thorax protocols can render incorrect dose results in the treatment planning system. When high soft-tissue contrast data are desired, high-quality head or pelvis scan protocol is recommended depending on the imaging area. The point dose method can be applicable to estimate CBCT dose with reasonable accuracy in the clinical environment.« less

Standardized limbal epithelial stem cell graft generation and transplantation.

PubMed

Zakaria, Nadia; Koppen, Carina; Van Tendeloo, Viggo; Berneman, Zwi; Hopkinson, Andrew; Tassignon, Marie-José

2010-10-01

To describe a standardized, xenogenic-free protocol for the manufacture of limbal epithelial stem cell grafts and a "no touch" surgical technique for its standardized transplantation. Antwerp University Hospital, Antwerp, Belgium. The limbo-amnion composite graft is generated by cultivating limbal epithelial stem cells on a standardized (thermolysin treated and spongy layer removed) amniotic membrane, stretched within an interlockable amnion ring. The cells are cultured in CnT-20 medium with the addition of 1% human AB serum for a period of 2 weeks. Fibrin glue is applied to the surgically prepared recipient's cornea and in one fluid motion, the composite graft within the amnion ring construct is transferred from culture and positioned onto the graft bed. The required size is cut out at the level of the limbus by means of a trephine and/or microsurgical scissors. The lightweight, plastic interlockable ring offered stability to the graft during culture, transport, and transplantation. The use of the standardized amniotic membrane, within the amnion ring construct, improves reproducibility of the results and therefore heralds elective surgery. Rapid transplantation of a wrinkle-free graft, using a sutureless, “no touch" technique was achieved and this allowed precise tailoring of the graft to the recipient bed. This is the first time a standardized, clinical grade protocol has been described for manufacturing limbal epithelial grafts with an efficient surgical technique that prevents postsurgical graft shrinkage and improves corneal integration. The quick, sutureless, and manipulation-free technique ensured transplantation of viable, proliferating limbal epithelial stem cells.

Bioreactor expansion of human mesenchymal stem cells according to GMP requirements.

PubMed

Elseberg, Christiane L; Salzig, Denise; Czermak, Peter

2015-01-01

In cell therapy, the use of autologous and allogenic human mesenchymal stem cells is rising. Accordingly, the supply of cells for clinical applications in highest quality is required. As hMSCs are considered as an advanced therapy medicinal products (ATMP), they underlie the requirements of GMP and PAT according to the authorities (FDA and EMA). The production process of these cells must therefore be documented according to GMP, which is usually performed via a GMP protocol based on standard operating procedures. This chapter provides an example of such a GMP protocol for hMSC, here a genetically modified allogenic cell line, based on a production process in a microcarrier-based stirred tank reactor including process monitoring according to PAT and final product quality assurance.

Xeno-Free Strategies for Safe Human Mesenchymal Stem/Stromal Cell Expansion: Supplements and Coatings

PubMed Central

Gonçalves, R. M.; Barrias, C. C.

2017-01-01

Human mesenchymal stem/stromal cells (hMSCs) have generated great interest in regenerative medicine mainly due to their multidifferentiation potential and immunomodulatory role. Although hMSC can be obtained from different tissues, the number of available cells is always low for clinical applications, thus requiring in vitro expansion. Most of the current protocols for hMSC expansion make use of fetal bovine serum (FBS) as a nutrient-rich supplement. However, regulatory guidelines encourage novel xeno-free alternatives to define safer and standardized protocols for hMSC expansion that preserve their intrinsic therapeutic potential. Since hMSCs are adherent cells, the attachment surface and cell-adhesive components also play a crucial role on their successful expansion. This review focuses on the advantages/disadvantages of FBS-free media and surfaces/coatings that avoid the use of animal serum, overcoming ethical issues and improving the expansion of hMSC for clinical applications in a safe and reproducible way. PMID:29158740

Performance factors of mobile rich media job aids for community health workers

PubMed Central

Florez-Arango, Jose F; Dunn, Kim; Zhang, Jiajie

2011-01-01

Objective To study and analyze the possible benefits on performance of community health workers using point-of-care clinical guidelines implemented as interactive rich media job aids on small-format mobile platforms. Design A crossover study with one intervention (rich media job aids) and one control (traditional job aids), two periods, with 50 community health workers, each subject solving a total 15 standardized cases per period per period (30 cases in total per subject). Measurements Error rate per case and task, protocol compliance. Results A total of 1394 cases were evaluated. Intervention reduces errors by an average of 33.15% (p=0.001) and increases protocol compliance 30.18% (p<0.001). Limitations Medical cases were presented on human patient simulators in a laboratory setting, not on real patients. Conclusion These results indicate encouraging prospects for mHealth technologies in general, and the use of rich media clinical guidelines on cell phones in particular, for the improvement of community health worker performance in developing countries. PMID:21292702

Performance factors of mobile rich media job aids for community health workers.

PubMed

Florez-Arango, Jose F; Iyengar, M Sriram; Dunn, Kim; Zhang, Jiajie

2011-01-01

To study and analyze the possible benefits on performance of community health workers using point-of-care clinical guidelines implemented as interactive rich media job aids on small-format mobile platforms. A crossover study with one intervention (rich media job aids) and one control (traditional job aids), two periods, with 50 community health workers, each subject solving a total 15 standardized cases per period per period (30 cases in total per subject). Error rate per case and task, protocol compliance. A total of 1394 cases were evaluated. Intervention reduces errors by an average of 33.15% (p = 0.001) and increases protocol compliance 30.18% (p < 0.001). Limitations Medical cases were presented on human patient simulators in a laboratory setting, not on real patients. These results indicate encouraging prospects for mHealth technologies in general, and the use of rich media clinical guidelines on cell phones in particular, for the improvement of community health worker performance in developing countries.

Arthroscopic management of the painful total elbow arthroplasty.

PubMed

Phadnis, Joideep; Bain, Gregory I

2016-01-01

Failure of total elbow arthroplasty is more common than after other major joint arthroplasties and is often a result of aseptic loosening, peri-prosthetic infection, fracture and instability. Infection can be a devastating complication, yet there are no established guidelines for the pre-operative diagnosis of total elbow peri-prosthetic infection. This is because pre-operative clinical, radiographic and biochemical tests are often unreliable. Using three case examples, a standardized protocol for the clinical and arthroscopic assessment of the painful total elbow arthroplasty is described. This is used to provide a mechanical and microbiological diagnosis of the patient's pain. There have been no complications resulting from the use of this technique in the three patients described, nor in any other patient to date. The staged protocol described in the present study, utilizing arthroscopic assessment, has refined the approach to the painful total elbow arthroplasty because it directly influences the definitive surgical management of the patient. It is recommended that other surgeons follow the principles outlined in the present study when faced with this challenging problem.

Efficacy of a polyvalent mastitis vaccine against Staphylococcus aureus on a dairy Mediterranean buffalo farm: results of two clinical field trials.

PubMed

Guccione, Jacopo; Pesce, Antonella; Pascale, Massimo; Salzano, Caterina; Tedeschi, Gianni; D'Andrea, Luigi; De Rosa, Angela; Ciaramella, Paolo

2017-01-19

In the last years the knowledges on Mediterranean Buffalo (MB) mastitis is remarkably improving, nevertheless the attention has been never focused on vaccination as preventive strategy for the control of mastitis in these ruminates. The aim of the current study was to assess clinical efficacy over time of two different preventive vaccination protocols against S. aureus mastitis, in primiparous MB.Vaccinated (VG) and not-vaccinated (N-VG) groups, of 30 MB each one, were selected from two different herds (herd A: VG1 and N-VG1; herd B: VG2 and N-VG2) of the same farm. Herd A received a double vaccination (Startvac®, 45 and 10 days before calving, protocol A), while in herd B an additional administration was performed (52 days after calving, protocol B). Bacteriological milk culture and assessment of somatic cell count (SCC) were performed at 10, 30, 60 and 90 days in milk (DIM) from composite milk samples. After 90 DIM, daily milk yields and SCC values were monthly detected until dry-off. The overall incidence of positive MB for S. aureus was 40.8% (49/120) in VG1 and 43.3% (52/120) in N-VG1 (Protocol A), while 45.8% (55/120) and 50.8% (61/120) in VG2 and N-VG2 (Protocol B). The latter was associated with a significant decreased in prevalence (at 90 DIM) and incidence of mastitis (animals positive for S. aureus, SCC > 200^10 3 , with or without clinical signs) in the vaccinated MB, while no difference occurred in protocol A. Moreover, herd B showed a significant reduction in prevalence of intramammary infection (animals positive for S. aureus, SCC < 200^10 3 , no clinical signs) in the vaccinated MB at 60 DIM while no differences were detected in herd A, at any sampling time; N-VG2 had significantly higher overall SCC values than VG2 (4.97 ± 4.75 and 4.84 ± 4.60 Log10 cells/mL ± standard deviation, respectively), while no differences were recorded in herd A. The current investigation explores for the first time the clinical efficacy of vaccinations against S. aureus infections in MB, showing encouraging results regarding reduction in mastitis and somatic cell count; the polyvalent mastitis vaccine may be considered an additional tool for in-herd S aureus infection and should be associated to other control procedures to maximize its properties.

Standard care versus protocol based therapy for new onset Pseudomonas aeruginosa in cystic fibrosis.

PubMed

Mayer-Hamblett, Nicole; Rosenfeld, Margaret; Treggiari, Miriam M; Konstan, Michael W; Retsch-Bogart, George; Morgan, Wayne; Wagener, Jeff; Gibson, Ronald L; Khan, Umer; Emerson, Julia; Thompson, Valeria; Elkin, Eric P; Ramsey, Bonnie W

2013-10-01

The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, P < 0.001). No significant differences in the incidence of hospitalization were observed between cohorts. Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa. © 2013 Wiley Periodicals, Inc.

Standard Care versus Protocol Based Therapy for New Onset Pseudomonas aeruginosa in Cystic Fibrosis

PubMed Central

Mayer-Hamblett, Nicole; Rosenfeld, Margaret; Treggiari, Miriam M.; Konstan, Michael W.; Retsch-Bogart, George; Morgan, Wayne; Wagener, Jeff; Gibson, Ronald L.; Khan, Umer; Emerson, Julia; Thompson, Valeria; Elkin, Eric P.; Ramsey, Bonnie W.

2014-01-01

Rationale The Early Pseudomonal Infection Control (EPIC) randomized trial rigorously evaluated the efficacy of different antibiotic regimens for eradication of newly identified Pseudomonas (Pa) in children with cystic fibrosis (CF). Protocol based therapy in the trial was provided based on culture positivity independent of symptoms. It is unclear whether outcomes observed in the clinical trial were different than those that would have been observed with historical standard of care driven more heavily by respiratory symptoms than culture positivity alone. We hypothesized that the incidence of Pa recurrence and hospitalizations would be significantly reduced among trial participants as compared to historical controls whose standard of care preceded the widespread adoption of tobramycin inhalation solution (TIS) as initial eradication therapy at the time of new isolation of Pa. Methods Eligibility criteria from the trial were used to derive historical controls from the Epidemiologic Study of CF (ESCF) who received standard of care treatment from 1995 to 1998, before widespread availability of TIS. Pa recurrence and hospitalization outcomes were assessed over a 15-month time period. Results As compared to 100% of the 304 trial participants, only 296/608 (49%) historical controls received antibiotics within an average of 20 weeks after new onset Pa. Pa recurrence occurred among 104/298 (35%) of the trial participants as compared to 295/549 (54%) of historical controls (19% difference, 95% CI: 12%, 26%, p<0.001). No significant differences in the incidence of hospitalization were observed between cohorts. Conclusions Protocol-based antimicrobial therapy for newly acquired Pa resulted in a lower rate of Pa recurrence but comparable hospitalization rates as compared to a historical control cohort less aggressively treated with antibiotics for new onset Pa. PMID:23818295

A quality analysis of clinical anaesthesia study protocols from the Chinese clinical trials registry according to the SPIRIT statement

PubMed Central

Yang, Lei; Chen, Shouming; Yang, Di; Li, Jiajin; Wu, Taixiang; Zuo, Yunxia

2018-01-01

Objective To learn about the overall quality of clinical anaesthesia study protocols from the Chinese Clinical Trials Registry and to discuss the way to improve study protocol quality. Methods We defined completeness of each sub-item in SPIRIT as N/A (not applicable) or with a score of 0, 1, or 2. For each protocol, we calculated the proportion of adequately reported items (score = 2 and N/A) and unreported items (score = 0). Protocol quality was determined according to the proportion of reported items, with values >50% indicating high quality. Protocol quality was determined according to the proportion of reported items. For each sub-item in SPIRIT, we calculated the adequately reported rate (percentage of all protocols with score 2 and NA on one sub-item) as well as the unreported rate (percentage of all protocols with score 0 on one sub-item). Results Total 126 study protocols were available for assessment. Among these, 88.1% were assessed as being of low quality. By comparison, the percentage of low-quality protocols was 88.9% after the publication of the SPIRIT statement. Among the 51 SPIRIT sub-items, 18 sub-items had an unreported rate above 90% while 16 had a higher adequately reported rate than an unreported rate. Conclusions The overall quality of clinical anaesthesia study protocols registered in the ChiCTR was poor. A mandatory protocol upload and self-check based on the SPIRIT statement during the trial registration process may improve protocol quality in the future. PMID:29872509

[Analysis of the quality of papers dealing with clinical trails in "Chinese Journal of Burns" during 2000-2004 by the standard of evidence-based medicine].

PubMed

Jia, Chi-yu; Wang, Yun-chuan; Bai, Feng

2006-02-01

To investigate the quality of reports of clinical results concerning burn injury, in order to raise the standard of clinical study of burn care in accordance to the standard of evidence-based medicine (EBM), with the aim of improving clinical research in burn care of this country. All the papers of clinical study published in Chinese Journal of Burns (CJB) from 2000 to 2004 were evaluated according to EBM standard. There were 89 papers about clinical trials published in the past 5 years, in which 43 (48.3%) of the studies were carried out with random control trials (RCT), and 46 (51.7%) were clinical control trials (CCT). RCT papers increased year by year, while the number of CCT papers fluctuated greatly. The disparity in the quality of research was found as follows. In all the RCT and CCT papers, blinded research was adopted only in 5 papers (5.6%). Strict diagnostic standard including inclusion and exclusion standards were reported in 53 articles (59.6%). The comparison with baselines was not provided in 64 articles (71.9%). P value was given in 10 papers but statistical method was not mentioned (11.2%). Follow-up visits and lost information were only recorded in 2 articles, but no detailed follow-up visiting data were provided. Side effects were reported in 10 articles (11.2%). There were analysis and explanation of mixed interfering factors only in 5 papers (5.6%). There was no explanation of the evaluation of sample size in any one paper. In summary, the literature concerning clinical studies published in CJB in the past five years has become more extensive. However, the present study indicates that many clinical trials are not designed and ethical consideration is often missing. Therefore, it is deemed imperative to improve the quality of the clinical studies by improving the planning of the protocols of the study and statistical analysis of the research results in future.

Study protocol of a mixed-methods evaluation of a cluster randomized trial to improve the safety of NSAID and antiplatelet prescribing: data-driven quality improvement in primary care.

PubMed

Grant, Aileen; Dreischulte, Tobias; Treweek, Shaun; Guthrie, Bruce

2012-08-28

Trials of complex interventions are criticized for being 'black box', so the UK Medical Research Council recommends carrying out a process evaluation to explain the trial findings. We believe it is good practice to pre-specify and publish process evaluation protocols to set standards and minimize bias. Unlike protocols for trials, little guidance or standards exist for the reporting of process evaluations. This paper presents the mixed-method process evaluation protocol of a cluster randomized trial, drawing on a framework designed by the authors. This mixed-method evaluation is based on four research questions and maps data collection to a logic model of how the data-driven quality improvement in primary care (DQIP) intervention is expected to work. Data collection will be predominately by qualitative case studies in eight to ten of the trial practices, focus groups with patients affected by the intervention and quantitative analysis of routine practice data, trial outcome and questionnaire data and data from the DQIP intervention. We believe that pre-specifying the intentions of a process evaluation can help to minimize bias arising from potentially misleading post-hoc analysis. We recognize it is also important to retain flexibility to examine the unexpected and the unintended. From that perspective, a mixed-methods evaluation allows the combination of exploratory and flexible qualitative work, and more pre-specified quantitative analysis, with each method contributing to the design, implementation and interpretation of the other.As well as strengthening the study the authors hope to stimulate discussion among their academic colleagues about publishing protocols for evaluations of randomized trials of complex interventions. DATA-DRIVEN QUALITY IMPROVEMENT IN PRIMARY CARE TRIAL REGISTRATION: ClinicalTrials.gov: NCT01425502.

Comparison of breathing gated CT images generated using a 5DCT technique and a commercial clinical protocol in a porcine model

PubMed Central

O’Connell, Dylan P.; Thomas, David H.; Dou, Tai H.; Lamb, James M.; Feingold, Franklin; Low, Daniel A.; Fuld, Matthew K.; Sieren, Jered P.; Sloan, Chelsea M.; Shirk, Melissa A.; Hoffman, Eric A.; Hofmann, Christian

2015-01-01

Purpose: To demonstrate that a “5DCT” technique which utilizes fast helical acquisition yields the same respiratory-gated images as a commercial technique for regular, mechanically produced breathing cycles. Methods: Respiratory-gated images of an anesthetized, mechanically ventilated pig were generated using a Siemens low-pitch helical protocol and 5DCT for a range of breathing rates and amplitudes and with standard and low dose imaging protocols. 5DCT reconstructions were independently evaluated by measuring the distances between tissue positions predicted by a 5D motion model and those measured using deformable registration, as well by reconstructing the originally acquired scans. Discrepancies between the 5DCT and commercial reconstructions were measured using landmark correspondences. Results: The mean distance between model predicted tissue positions and deformably registered tissue positions over the nine datasets was 0.65 ± 0.28 mm. Reconstructions of the original scans were on average accurate to 0.78 ± 0.57 mm. Mean landmark displacement between the commercial and 5DCT images was 1.76 ± 1.25 mm while the maximum lung tissue motion over the breathing cycle had a mean value of 27.2 ± 4.6 mm. An image composed of the average of 30 deformably registered images acquired with a low dose protocol had 6 HU image noise (single standard deviation) in the heart versus 31 HU for the commercial images. Conclusions: An end to end evaluation of the 5DCT technique was conducted through landmark based comparison to breathing gated images acquired with a commercial protocol under highly regular ventilation. The techniques were found to agree to within 2 mm for most respiratory phases and most points in the lung. PMID:26133604

Laser Tattoo Removal: A Clinical Update

PubMed Central

Ho, Stephanie GY; Goh, Chee Leok

2015-01-01

Techniques for tattoo removal have evolved significantly over the years. The commonly used Quality-switched (QS) ruby, alexandrite, and Nd:YAG lasers are the traditional workhorses for tattoo removal. Newer strategies using combination laser treatments, multi-pass treatments, and picosecond lasers offer promising results. The tattoo color and skin type of the patient are important considerations when choosing the appropriate laser. Standard protocols can be developed for the effective and safe treatment of tattoos. PMID:25949017

Improving Balance in TBI Using a Low Cost Customized Virtual Reality Rehabilitation Tool

DTIC Science & Technology

2015-10-01

INVESTIGATOR(S): Denise Krch, PhD CONTRACTING ORGANIZATION: Kessler Foundation West Orange , NJ 07052 REPORT DATE: October 2015 TYPE OF REPORT...Z39.18 email: dkrch@kesslerfoundation.org Kessler Foundation West Orange , NJ 07052 14 3 Table of Contents Page 1. Introduction 3 2. Keywords 3 3... Orange , NJ, USA  Significant contribution to the manualization of the Standard of Care and the Mystic Isle treatment protocols.  Training clinical

Phase 3 Clinical Trials: D-Methionine to Reduce Noise-Induced Hearing Loss

DTIC Science & Technology

2013-03-01

tympanometry, and pure-tone hearing threshold testing at .5, 1, 2, 3, 4, 6, 8 kHz bilaterally. Tinnitus will be measured using standardized ...chemistry, and urinalysis ) on all study participants. The purpose of these recommendations were 1) to exclude participants with mild renal impairment until...analysis and urinalysis for the study participants to the study protocol. Therefore, during the third quarter, no additions were made to the original

Development of an Inter-Service Complex Wound and Limb Salvage Center within the DoD (Briefing charts)

DTIC Science & Technology

2010-10-15

CWLSC Patient Growth: 2008-2010  Complex soft-tissue wound management in austere settings  NPWT/VAC application and management  Ostomy , fistula, and...acute and chronic wounds Complex Wound Limb Salvage Program WRAMC/NNMC Inpatient Care Wound and Ostomy NNMC and WRAMC Outpatient Care 2 Clinics...Standardization Ostomy Wound care Skin Care Cleansers Research / EBP Pressure ulcer protocol CPG development Wound education research grant WRNMMC

Protocol for a systematic review and economic evaluation of the clinical and cost-effectiveness of non-hospital-based non-invasive ventilation (NIV) in patients with stable end-stage COPD with hypercapnic respiratory failure.

PubMed

Dave, Chirag; Turner, Alice; Dretzke, Janine; Bayliss, Sue; O'Brien, Deirdre; Jowett, Sue; Moore, David

2014-03-27

Chronic obstructive pulmonary disease (COPD) remains a significant public health burden. Non-invasive ventilation (NIV) is a method of supported breathing used as standard care for acutely unwell patients in hospital with COPD, but there is uncertainty around the potential benefits of using NIV in the treatment of stable patients in a non-hospital setting. This is a protocol for systematic reviews of the clinical and cost-effectiveness of NIV in this context, being undertaken in support of a model based economic evaluation. Standard systematic review methods aimed at minimising bias will be employed for study identification, selection and data extraction for both the clinical and economic systematic reviews. Bibliographic databases (for example MEDLINE, EMBASE) and ongoing trials registers will be searched from 1980 onwards. The search strategy will combine terms for the population with those for the intervention. Studies will be selected for review if the population includes adult patients with COPD and hypercapnic respiratory failure, however defined. Systematic reviews, randomised controlled trials and observational studies (with n >1) will be included, and quality assessment will be tailored to the different study designs. The primary outcome measures of interest are survival, quality of life, and healthcare utilisations (hospitalisation and Accident and Emergency attendances). Meta-analyses will be undertaken where clinical and methodological homogeneity exists, supported by predefined subgroup analyses where appropriate. A systematic review of the evidence on the cost-effectiveness of non-hospital NIV will be completed, and a model-based cost-utility analysis undertaken to determine the cost-effectiveness of non-hospital-based NIV compared with standard care. These reviews will attempt to clarify the clinical effectiveness of non-hospital NIV in COPD patients as well as the cost-effectiveness. The findings may indicate whether NIV in a non-hospital setting should be considered more routinely in this patient group, and what the likely cost implications will be. 2012:CRD42012003286.

HIV and Cognitive Impairment in Clinical Practice: The Evaluation of a Stepwise Screening Protocol in Relation to Clinical Outcomes and Management.

PubMed

Hakkers, Charlotte S; Kraaijenhof, Jordan M; van Oers-Hazelzet, Esther B; Visser-Meily, Anne J M A; Hoepelman, Andy I M; Arends, Joop E; Barth, Roos E

2017-09-01

Neurocognitive impairment (NCI) is an increasingly important comorbidity in an ageing HIV+ population. Despite the lack of available treatment modalities, screening for NCI is recommended. In the UMC Utrecht, yearly NCI screening is done using the Montreal Cognitive Assessment (MoCA) tool and the HIV Dementia Scale (HDS). The aim of this study was to evaluate this screening protocol in relation to clinical outcomes and management. A retrospective cohort study was performed in suppressed adult HIV+ patients. Apart from the MoCa and the HDS, the Utrecht Scale for Evaluation of Rehabilitation-Participation (USER-P) and the Hospital Anxiety and Depression Scale (HADS) were performed. Patients scoring below average on cognitive screening tests or with subjective cognitive complaints were further evaluated using a standardized protocol, including optimizing cART and checking for somatic disorders. In patients with cognitive complaints and participation restrictions, cognitive rehabilitation was proposed. Two hundred eighty-six patients were screened. The vast majority were MSM with an average age of 49 years. One hundred forty-four out of 286 patients (50%) had an abnormal test score and/or had subjective cognitive complaints. Restrictions in participation were present in 23% of patients. Six patients on Efavirenz switched their regimes, as this drug is known for its potential central nervous system (CNS) side effects. A depressive component was present in 58 patients (40%). Five patients had a clinical relevant laboratory abnormality. Moreover, six patients were referred for cognitive rehabilitation, which resulted in a 100% success rate in set goals in the five evaluable patients. Although the protocol was not fully adhered to in all patients, it did result in detectable underlying causes of NCI in 59% of patients, and 21% was referred for further treatment. Moreover, cognitive rehabilitation appears to be a very successful intervention for patients with NCI who experience subjective complaints and participation restrictions.

Additional considerations are required when preparing a protocol for a systematic review with multiple interventions.

PubMed

Chaimani, Anna; Caldwell, Deborah M; Li, Tianjing; Higgins, Julian P T; Salanti, Georgia

2017-03-01

The number of systematic reviews that aim to compare multiple interventions using network meta-analysis is increasing. In this study, we highlight aspects of a standard systematic review protocol that may need modification when multiple interventions are to be compared. We take the protocol format suggested by Cochrane for a standard systematic review as our reference and compare the considerations for a pairwise review with those required for a valid comparison of multiple interventions. We suggest new sections for protocols of systematic reviews including network meta-analyses with a focus on how to evaluate their assumptions. We provide example text from published protocols to exemplify the considerations. Standard systematic review protocols for pairwise meta-analyses need extensions to accommodate the increased complexity of network meta-analysis. Our suggested modifications are widely applicable to both Cochrane and non-Cochrane systematic reviews involving network meta-analyses. Copyright © 2017 Elsevier Inc. All rights reserved.

Connecting the clinical IT infrastructure to a service-oriented architecture of medical devices.

PubMed

Andersen, Björn; Kasparick, Martin; Ulrich, Hannes; Franke, Stefan; Schlamelcher, Jan; Rockstroh, Max; Ingenerf, Josef

2018-02-23

The new medical device communication protocol known as IEEE 11073 SDC is well-suited for the integration of (surgical) point-of-care devices, so are the established Health Level Seven (HL7) V2 and Digital Imaging and Communications in Medicine (DICOM) standards for the communication of systems in the clinical IT infrastructure (CITI). An integrated operating room (OR) and other integrated clinical environments, however, need interoperability between both domains to fully unfold their potential for improving the quality of care as well as clinical workflows. This work thus presents concepts for the propagation of clinical and administrative data to medical devices, physiologic measurements and device parameters to clinical IT systems, as well as image and multimedia content in both directions. Prototypical implementations of the derived components have proven to integrate well with systems of networked medical devices and with the CITI, effectively connecting these heterogeneous domains. Our qualitative evaluation indicates that the interoperability concepts are suitable to be integrated into clinical workflows and are expected to benefit patients and clinicians alike. The upcoming HL7 Fast Healthcare Interoperability Resources (FHIR) communication standard will likely change the domain of clinical IT significantly. A straightforward mapping to its resource model thus ensures the tenability of these concepts despite a foreseeable change in demand and requirements.

Impact of a risk management plan on Legionella contamination of dental unit water.

PubMed

Leoni, Erica; Dallolio, Laura; Stagni, Francesca; Sanna, Tiziana; D'Alessandro, Giovanni; Piana, Gabriela

2015-02-23

The study aimed to assess the prevalence of Legionella spp. in dental unit waterlines of a dental clinic and to verify whether the microbiological parameters used as indicators of water quality were correlated with Legionella contamination. A risk management plan was subsequently implemented in the dental health care setting, in order to verify whether the adopted disinfection protocols were effective in preventing Legionella colonization. The water delivered from syringes and turbines of 63 dental units operating in a dental clinic, was monitored for counts of the heterotrophic bacteria P. aeruginosa and Legionella spp. (22 °C and 37 °C). At baseline, output water from dental units continuously treated with disinfection products was more compliant with the recommended standards than untreated and periodically treated water. However, continuous disinfection was still not able to prevent contamination by Legionella and P. aeruginosa. Legionella was isolated from 36.4%, 24.3% and 53.3% of samples from untreated, periodically and continuously treated waterlines, respectively. The standard microbiological parameters used as indicators of water quality proved to be unreliable as predictors of the presence of Legionella, whose source was identified as the tap water used to supply the dental units. The adoption of control measures, including the use of deionized water in supplying the dental unit waterlines and the application of a combined protocol of continuous and periodic disinfection, with different active products for the different devices, resulted in good control of Legionella contamination. The efficacy of the measures adopted was mainly linked to the strict adherence to the planned protocols, which placed particular stress on staff training and ongoing environmental monitoring.

Bivalirudin versus heparin in primary PCI: clinical outcomes and cost analysis

PubMed Central

Deharo, Pierre; Johnson, Thomas W; Rahbi, Hazim; Kandan, Raveen; Bowles, Ruth; Mozid, Abdul; Dorman, Stephen; Strange, Julian W; Baumbach, Andreas

2018-01-01

Background The evidence for benefits of bivalirudin over heparin has recently been challenged. We aimed to analyse the safety and cost-effectiveness following reintroduction of heparin instead of bivalirudin as the standard anticoagulation for primary percutaneous coronary intervention (PPCI) in a high-volume centre. Methods and results This analysis was an open-label, prospective registry including all patients admitted to our centre for PPCI from April 2014 to April 2016. Heparin was reintroduced as standard anticoagulant in April 2015. During the 2 years, 1291 patients underwent a PPCI, 662 in the Bivalirudin protocol period (Cohort B) and 629 in the Heparin protocol period (Cohort H). Baseline and procedural characteristics were not significantly different, except for a higher use of thromboaspiration and femoral access in the earlier Cohort B. Glycoprotein 2b3a (Gp2b3a) antagonists were used in 24% of the patients in Cohort B versus 28% in Cohort H (P<0.01). We did not observe any differences in death at 180 days (11.03% in Cohort B vs 11.29% in Cohort H)(HR 95% CI 0.98 (0.72 to 1.33), P=0.88). The incidence of any bleeding complications at 30 days did not differ between the two periods (21.9% vs 21.9%, P=0.99). The cost related to the anticoagulants amounted to £246 236 in Cohort B versus £4483 in Cohort H (£324 406 vs £102 347 when adding Gp2b3a antagonists). Conclusion We did not find clinically relevant changes in patient outcomes, including bleeding complications with reintroduction of heparin in our PPCI protocol. However, the use of heparin was associated with a major reduction in treatment costs. PMID:29765614

Evolutionary cognitive therapy versus standard cognitive therapy for depression: a protocol for a blinded, randomized, superiority clinical trial.

PubMed

Giosan, Cezar; Cobeanu, Oana; Mogoase, Cristina; Muresan, Vlad; Malta, Loretta S; Wyka, Katarzyna; Szentagotai, Aurora

2014-03-19

Depression is estimated to become the leading cause of disease burden globally by 2030. Despite existing efficacious treatments (both medical and psychotherapeutic), a large proportion of patients do not respond to therapy. Recent insights from evolutionary psychology suggest that, in addition to targeting the proximal causes of depression (for example, targeting dysfunctional beliefs by cognitive behavioral therapy), the distal or evolutionary causes (for example, inclusive fitness) should also be addressed. A randomized superiority trial is conducted to develop and test an evolutionary-driven cognitive therapy protocol for depression, and to compare its efficacy against standard cognitive therapy for depression. Romanian-speaking adults (18 years or older) with elevated Beck Depression Inventory (BDI) scores (>13), current diagnosis of major depressive disorder or major depressive episode (MDD or MDE), and MDD with comorbid dysthymia, as evaluated by the Structured Clinical Interview for DSM-IV (SCID), are included in the study. Participants are randomized to one of two conditions: 1) evolutionary-driven cognitive therapy (ED-CT) or 2) cognitive therapy (CT). Both groups undergo 12 psychotherapy sessions, and data are collected at baseline, mid-treatment, post-treatment, and the 3-month follow-up. Primary outcomes are depressive symptomatology and a categorical diagnosis of depression post-treatment. This randomized trial compares the newly proposed ED-CT with a classic CT protocol for depression. To our knowledge, this is the first attempt to integrate insights from evolutionary theories of depression into the treatment of this condition in a controlled manner. This study can thus add substantially to the body of knowledge on validated treatments for depression. Current Controlled Trials ISRCTN64664414The trial was registered in June 2013. The first participant was enrolled on October 3, 2012.

Cryopreservation of hematopoietic stem and progenitor cells amplified ex vivo from cord blood CD34+ cells.

PubMed

Duchez, Pascale; Chevaleyre, Jean; Brunet de la Grange, Philippe; Vlaski, Marija; Boiron, Jean-Michel; Wouters, Guy; Ivanovic, Zoran

2013-09-01

Our ex vivo expansion procedure starting from cord blood (CB) CD34+ cells enabled expansion of committed progenitors (CPs) without a negative impact on hematopoietic stem cells (HSCs) exhibiting both short- and long-term repopulating capacity. Upgraded to clinical scale (Macopharma HP01 in the presence of stem cell factor, FLT3-L [100 ng/mL each], granulocyte-colony-stimulating factor [10 ng/mL], and thrombopoietin [20 ng/mL]), it is being used for an ongoing clinical trial (adult allogeneic context) yielding promising preliminary results. Transplantation of ex vivo expanded CB cells is becoming a reality, while the issue of expanded cells' cryopreservation emerges as an option that allows the conservation of the product for transportation and future use. Here, we investigated whether it is possible to maintain the functional HSC and CP properties after freezing and thawing of expanded cells. We compared cryopreservation efficiency of the ex vivo expanded CB cells using the standard protocol (freezing solution human serum albumin (HSA)-dimethyl sulfoxide [DMSO]) with the newly designed protocol based on an enriched freezing solution (HP01-DMSO) with respect to the viability index, number of CD34+ and total cells, and recovery of CPs (colony-forming units) and HSCs (NOG/Scid/gamma-null mice engraftment). Cryopreservation and thawing of expanded CB cells using the "standard" procedure (HSA-DMSO) reduced recovery of the CPs (40%) and HSCs (drastically decreasing engraftment capacity). HP01-based protocol resulted in improvement of preservation of both CPs (>60%) and HSCs (nonaltered engraftment capacities). Functional maintenance of the expanded graft by cryopreservation is feasible in conditions compatible with human cell therapy requirements. © 2012 American Association of Blood Banks.

Validation of the Konsung QD217A for clinical use and self-measurement according to the European Society of Hypertension International Protocol.

PubMed

Wu, Ning; Zhang, Xuezhong; Wang, Wen; Zhang, Hongye

2015-08-01

This study aimed to evaluate the accuracy of the automated oscillometric upper arm blood pressure (BP) monitor Konsung QD217A for home BP monitoring according to the European Society of Hypertension International Protocol revision 2010. Three trained observers validated the performance of these devices by comparing the measurements obtained from these devices with those taken using a standard mercury sphygmomanometer. Systolic blood pressure (SBP) and diastolic blood pressure (DBP) were sequentially measured in 33 participants using a standard mercury sphygmomanometer and the Konsung QD217A device. A total of 99 pairs of comparisons were obtained from 33 participants. The QD217A device achieved the targets in part 1 of the validation study. The number of absolute differences between the device and the observers within a range of 5, 10 and 15 mmHg was 70/99, 92/99 and 96/99, respectively, for SBP and 80/99, 94/99 and 99/99, respectively, for DBP. The device also achieved the targets in part 2 of the validation study. A total of 27 and 31 participants for SBP and DBP, respectively, showed at least two of the three device-observers differences within 5 mmHg (required≥24). The number of participants without device-observer difference within 5 mmHg was one for SBP and one for DBP (required≤3). The Konsung upper arm BP monitor QD217A has passed the International Protocol requirements and it can be recommended for clinical use and self-measurement in adults. Copyright © 2015 Wolters Kluwer Health, Inc. All rights reserved.

Effectiveness of standardized approach versus usual care on physiotherapy treatment for patients submitted to alveolar bone graft: a pilot study.

PubMed

Vidotto, Laís Silva; Bigliassi, Marcelo; Alencar, Tatiane Romanini Rodrigues; Silva, Thaísa Maria Santos; Probst, Vanessa Suziane

2015-07-01

To compare the acute effects of a standardized physiotherapy protocol versus a typical non-standardized physiotherapy protocol on pain and performance of patients undergoing alveolar bone graft (ABG). Sixteen patients (9 males; 12 [11-13] years) with cleft lip and palate undergoing ABG were allocated into two groups: (1) experimental group--EG (standardized physiotherapy protocol); and (2) control group--CG (typical, non-standardized physiotherapy treatment). Range of motion, muscle strength, gait speed, and pain level were assessed prior to surgical intervention (PRE), as well as on the first, second, and third post-operative days (1st, 2nd, and 3rd PO, respectively). Recovery with respect to range of motion of hip flexion was more pronounced in the EG (64.6 ± 11.0°) in comparison to the CG (48.5 ± 17.7° on the 3rd PO; p < 0.05). In addition, less pain was observed in the EG (0 [0-0.2] versus 2 [0.7-3] in the CG on the 3rd PO; p < 0.05). A standardized physiotherapy protocol appears to be better than a non-standardized physiotherapy protocol for acute improvement of range of motion of hip flexion and for reducing pain in patients undergoing ABG.